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CMS unveils replacement for the Oncology Care Model
that ended on June 30.
The OCM’s successor, known as the Enhancing Oncology Model (EOM), will begin next year on July 1, and run for 5 years.
Like the OCM, the EOM will align payment incentives with care quality, and focus on value-based, patient-centered care for those undergoing chemotherapy based on 6-month episodes of care. The EOM will focus on health equity, and participants will include oncology practices that treat Medicare beneficiaries receiving chemotherapy for seven types of cancer: breast cancer, chronic leukemia, lung cancer, lymphoma, multiple myeloma, prostate cancer, and small intestine/colorectal cancer.
The new model will build on lessons learned from the OCM, incorporating successful elements of the previous model, such as patient navigation and care planning, and will introduce new elements, including gradually implementing electronic Patient-Reported Outcomes and activities that promote health equity.
In a statement, CMS Administrator Chiquita Brooks-LaSure noted that the EOM will “incentivize participating oncology practices – including those in rural and underserved areas – to improve the provision of high-quality, coordinated care that addresses patients’ social needs and improves patient and caregiver support.”
The goal, Ms. Brooks-LaSure added, is to address “stark inequities in the ability of people with cancer across race, gender, region, and income to access cancer screening, diagnostics, and treatment. CMS is working to advance President Biden’s Cancer Moonshot goals by helping Medicare cancer patients better navigate a challenging and often overwhelming journey.”
Applauds and concerns
The American Society of Clinical Oncology, the Association of Community Cancer Centers, and the Community Oncology Alliance all issued statements applauding the new model and the fact that it is voluntary. But they have also voiced several concerns.
The COA, for example, noted that the CMS Innovation Center plans to cut the Monthly Enhanced Oncology Services payments in the EOM by more than half ($70 vs $160 for the OCM), but at the same time, expects more work from practices.
While COA is “extremely supportive” of screening for health-related social needs and electronic patient-reported outcomes, “it seems unfair to burden practices with more work but pay less for it, particularly as practices are dealing with the return of the Medicare sequester cut, inflation, and ongoing COVID-19 practice challenges,” Ted Okon, executive director of COA, wrote in a statement.
COA also expressed concern with the 1-year gap between the end of the OCM and the start of EOM.
“During this time practices will have to shoulder the extensive investments and operational changes put in place to benefit patients without reimbursement,” Mr. Okon said.
ASCO echoed COA’s concerns and the ACCC expressed unease with some of the structural elements of the program.
The EOM includes two risk arrangements with different degrees of downside risk. However, requiring participants to accept downside risk from the start of the model “will be a significant barrier to enrollment given the current reimbursement landscape,” the ACCC said in a statement. This risk “may not make financial sense for smaller oncology programs, particularly those who care for underserved patients and those that have not previously participated in OCM.”
Instead, CMS should “endeavor to provide as much information on proposed payment methodologies, cost data, and benchmark amounts as early as possible so that practices can make informed decisions around participation,” the ACCC wrote.
An improvement over OCM?
The OCM represented the largest alternative payment model to address value-based payment for cancer care. More than 3,200 oncologists and 201 physician practices voluntarily entered the program, which lasted 6 years.
But since its implementation, studies assessing the success of the program have yielded mixed results.
A 2018 analysis, for instance, revealed that one large community practice saved Medicare $3 million over a year after adopting the OCM.
However, a 2021 study found that, while community practices experienced lower drug costs in lung and prostate cancer and lower office-based costs after implementing the program, the difference was not statistically significant when accounting for all costs.
Another analysis also revealed more mixed results, reporting cost reductions for all cancers, but also finding those savings were offset by administrative expenses. Overall, this study found the OCM led to a $155 million net loss to Medicare over 4 years.
Will the EOM improve upon the OCM?
According to the CMS, “the central goal of EOM is to better support patients and improve their care experience.”
Participating Physician Group Practices will take accountability for health care quality and total spending during 6-month episodes of care for Medicare patients with certain cancers.
CMS will give participants the option to bill for Monthly Enhanced Oncology Services payment for services provided to eligible beneficiaries. This payment will be higher for beneficiaries dually eligible for Medicare and Medicaid.
EOM participants will have the opportunity to earn a retrospective performance-based payment based on quality and savings. Participants will be required to take on downside risk from the start of the model, with the potential to owe CMS a performance-based recoupment.
EOM participants will be required to implement participant redesign activities, including 24/7 access to care, patient navigation, care planning, use of evidence-based guidelines, use of electronic Patient Reported Outcomes, screening for health-related social needs, use of data for quality improvement, and use of certified electronic health record technology.
“No one should have to battle cancer without access to high-quality, coordinated care,” said Health & Human Services Secretary Xavier Becerra, in a statement. “With this new Innovation Center model for oncology care, we are delivering on President Biden’s call to action to mobilize every option to address cancer, and creating a system of care that supports all patients and their families.”
A detailed payment methodology paper will be published for EOM this summer and will be available on the Innovation Center’s website.
A version of this article first appeared on Medscape.com.
that ended on June 30.
The OCM’s successor, known as the Enhancing Oncology Model (EOM), will begin next year on July 1, and run for 5 years.
Like the OCM, the EOM will align payment incentives with care quality, and focus on value-based, patient-centered care for those undergoing chemotherapy based on 6-month episodes of care. The EOM will focus on health equity, and participants will include oncology practices that treat Medicare beneficiaries receiving chemotherapy for seven types of cancer: breast cancer, chronic leukemia, lung cancer, lymphoma, multiple myeloma, prostate cancer, and small intestine/colorectal cancer.
The new model will build on lessons learned from the OCM, incorporating successful elements of the previous model, such as patient navigation and care planning, and will introduce new elements, including gradually implementing electronic Patient-Reported Outcomes and activities that promote health equity.
In a statement, CMS Administrator Chiquita Brooks-LaSure noted that the EOM will “incentivize participating oncology practices – including those in rural and underserved areas – to improve the provision of high-quality, coordinated care that addresses patients’ social needs and improves patient and caregiver support.”
The goal, Ms. Brooks-LaSure added, is to address “stark inequities in the ability of people with cancer across race, gender, region, and income to access cancer screening, diagnostics, and treatment. CMS is working to advance President Biden’s Cancer Moonshot goals by helping Medicare cancer patients better navigate a challenging and often overwhelming journey.”
Applauds and concerns
The American Society of Clinical Oncology, the Association of Community Cancer Centers, and the Community Oncology Alliance all issued statements applauding the new model and the fact that it is voluntary. But they have also voiced several concerns.
The COA, for example, noted that the CMS Innovation Center plans to cut the Monthly Enhanced Oncology Services payments in the EOM by more than half ($70 vs $160 for the OCM), but at the same time, expects more work from practices.
While COA is “extremely supportive” of screening for health-related social needs and electronic patient-reported outcomes, “it seems unfair to burden practices with more work but pay less for it, particularly as practices are dealing with the return of the Medicare sequester cut, inflation, and ongoing COVID-19 practice challenges,” Ted Okon, executive director of COA, wrote in a statement.
COA also expressed concern with the 1-year gap between the end of the OCM and the start of EOM.
“During this time practices will have to shoulder the extensive investments and operational changes put in place to benefit patients without reimbursement,” Mr. Okon said.
ASCO echoed COA’s concerns and the ACCC expressed unease with some of the structural elements of the program.
The EOM includes two risk arrangements with different degrees of downside risk. However, requiring participants to accept downside risk from the start of the model “will be a significant barrier to enrollment given the current reimbursement landscape,” the ACCC said in a statement. This risk “may not make financial sense for smaller oncology programs, particularly those who care for underserved patients and those that have not previously participated in OCM.”
Instead, CMS should “endeavor to provide as much information on proposed payment methodologies, cost data, and benchmark amounts as early as possible so that practices can make informed decisions around participation,” the ACCC wrote.
An improvement over OCM?
The OCM represented the largest alternative payment model to address value-based payment for cancer care. More than 3,200 oncologists and 201 physician practices voluntarily entered the program, which lasted 6 years.
But since its implementation, studies assessing the success of the program have yielded mixed results.
A 2018 analysis, for instance, revealed that one large community practice saved Medicare $3 million over a year after adopting the OCM.
However, a 2021 study found that, while community practices experienced lower drug costs in lung and prostate cancer and lower office-based costs after implementing the program, the difference was not statistically significant when accounting for all costs.
Another analysis also revealed more mixed results, reporting cost reductions for all cancers, but also finding those savings were offset by administrative expenses. Overall, this study found the OCM led to a $155 million net loss to Medicare over 4 years.
Will the EOM improve upon the OCM?
According to the CMS, “the central goal of EOM is to better support patients and improve their care experience.”
Participating Physician Group Practices will take accountability for health care quality and total spending during 6-month episodes of care for Medicare patients with certain cancers.
CMS will give participants the option to bill for Monthly Enhanced Oncology Services payment for services provided to eligible beneficiaries. This payment will be higher for beneficiaries dually eligible for Medicare and Medicaid.
EOM participants will have the opportunity to earn a retrospective performance-based payment based on quality and savings. Participants will be required to take on downside risk from the start of the model, with the potential to owe CMS a performance-based recoupment.
EOM participants will be required to implement participant redesign activities, including 24/7 access to care, patient navigation, care planning, use of evidence-based guidelines, use of electronic Patient Reported Outcomes, screening for health-related social needs, use of data for quality improvement, and use of certified electronic health record technology.
“No one should have to battle cancer without access to high-quality, coordinated care,” said Health & Human Services Secretary Xavier Becerra, in a statement. “With this new Innovation Center model for oncology care, we are delivering on President Biden’s call to action to mobilize every option to address cancer, and creating a system of care that supports all patients and their families.”
A detailed payment methodology paper will be published for EOM this summer and will be available on the Innovation Center’s website.
A version of this article first appeared on Medscape.com.
that ended on June 30.
The OCM’s successor, known as the Enhancing Oncology Model (EOM), will begin next year on July 1, and run for 5 years.
Like the OCM, the EOM will align payment incentives with care quality, and focus on value-based, patient-centered care for those undergoing chemotherapy based on 6-month episodes of care. The EOM will focus on health equity, and participants will include oncology practices that treat Medicare beneficiaries receiving chemotherapy for seven types of cancer: breast cancer, chronic leukemia, lung cancer, lymphoma, multiple myeloma, prostate cancer, and small intestine/colorectal cancer.
The new model will build on lessons learned from the OCM, incorporating successful elements of the previous model, such as patient navigation and care planning, and will introduce new elements, including gradually implementing electronic Patient-Reported Outcomes and activities that promote health equity.
In a statement, CMS Administrator Chiquita Brooks-LaSure noted that the EOM will “incentivize participating oncology practices – including those in rural and underserved areas – to improve the provision of high-quality, coordinated care that addresses patients’ social needs and improves patient and caregiver support.”
The goal, Ms. Brooks-LaSure added, is to address “stark inequities in the ability of people with cancer across race, gender, region, and income to access cancer screening, diagnostics, and treatment. CMS is working to advance President Biden’s Cancer Moonshot goals by helping Medicare cancer patients better navigate a challenging and often overwhelming journey.”
Applauds and concerns
The American Society of Clinical Oncology, the Association of Community Cancer Centers, and the Community Oncology Alliance all issued statements applauding the new model and the fact that it is voluntary. But they have also voiced several concerns.
The COA, for example, noted that the CMS Innovation Center plans to cut the Monthly Enhanced Oncology Services payments in the EOM by more than half ($70 vs $160 for the OCM), but at the same time, expects more work from practices.
While COA is “extremely supportive” of screening for health-related social needs and electronic patient-reported outcomes, “it seems unfair to burden practices with more work but pay less for it, particularly as practices are dealing with the return of the Medicare sequester cut, inflation, and ongoing COVID-19 practice challenges,” Ted Okon, executive director of COA, wrote in a statement.
COA also expressed concern with the 1-year gap between the end of the OCM and the start of EOM.
“During this time practices will have to shoulder the extensive investments and operational changes put in place to benefit patients without reimbursement,” Mr. Okon said.
ASCO echoed COA’s concerns and the ACCC expressed unease with some of the structural elements of the program.
The EOM includes two risk arrangements with different degrees of downside risk. However, requiring participants to accept downside risk from the start of the model “will be a significant barrier to enrollment given the current reimbursement landscape,” the ACCC said in a statement. This risk “may not make financial sense for smaller oncology programs, particularly those who care for underserved patients and those that have not previously participated in OCM.”
Instead, CMS should “endeavor to provide as much information on proposed payment methodologies, cost data, and benchmark amounts as early as possible so that practices can make informed decisions around participation,” the ACCC wrote.
An improvement over OCM?
The OCM represented the largest alternative payment model to address value-based payment for cancer care. More than 3,200 oncologists and 201 physician practices voluntarily entered the program, which lasted 6 years.
But since its implementation, studies assessing the success of the program have yielded mixed results.
A 2018 analysis, for instance, revealed that one large community practice saved Medicare $3 million over a year after adopting the OCM.
However, a 2021 study found that, while community practices experienced lower drug costs in lung and prostate cancer and lower office-based costs after implementing the program, the difference was not statistically significant when accounting for all costs.
Another analysis also revealed more mixed results, reporting cost reductions for all cancers, but also finding those savings were offset by administrative expenses. Overall, this study found the OCM led to a $155 million net loss to Medicare over 4 years.
Will the EOM improve upon the OCM?
According to the CMS, “the central goal of EOM is to better support patients and improve their care experience.”
Participating Physician Group Practices will take accountability for health care quality and total spending during 6-month episodes of care for Medicare patients with certain cancers.
CMS will give participants the option to bill for Monthly Enhanced Oncology Services payment for services provided to eligible beneficiaries. This payment will be higher for beneficiaries dually eligible for Medicare and Medicaid.
EOM participants will have the opportunity to earn a retrospective performance-based payment based on quality and savings. Participants will be required to take on downside risk from the start of the model, with the potential to owe CMS a performance-based recoupment.
EOM participants will be required to implement participant redesign activities, including 24/7 access to care, patient navigation, care planning, use of evidence-based guidelines, use of electronic Patient Reported Outcomes, screening for health-related social needs, use of data for quality improvement, and use of certified electronic health record technology.
“No one should have to battle cancer without access to high-quality, coordinated care,” said Health & Human Services Secretary Xavier Becerra, in a statement. “With this new Innovation Center model for oncology care, we are delivering on President Biden’s call to action to mobilize every option to address cancer, and creating a system of care that supports all patients and their families.”
A detailed payment methodology paper will be published for EOM this summer and will be available on the Innovation Center’s website.
A version of this article first appeared on Medscape.com.
Radiotherapy for brain metastases: ASTRO updates guidelines
“In the decade since the previous ASTRO brain metastases guideline, there has been a tremendous evolution in the way we manage patients’ disease,” said Paul D. Brown, MD, chair of the guideline task force and a professor of radiation oncology at the Mayo Clinic in Rochester, Minn.
“The development of stereotactic radiosurgery (SRS) has allowed treatment of limited brain metastases alone, often in a single fraction, while largely sparing the surrounding brain,” he elaborated in a statement. Also, novel techniques such as hippocampal avoidance with whole-brain radiation can greatly improve quality of life, he added.
The guideline was published May 6 in Practical Radiation Oncology.
“With the emergence of novel radiotherapy techniques and technologies, brain-penetrating drug therapies and neurosurgical interventions, modern management of brain metastases has become increasingly personalized, complex and multidisciplinary,” Vinai Gondi, MD, vice chair of the guideline task force and director of research and education at the Northwestern Medicine Cancer Center and Proton Center in Chicago, said in a statement.
“We developed this guideline to help inform and guide clinicians in patient-centered, multidisciplinary care for their patients with brain metastases,” he added.
Key recommendations
Overall, the recommendations address a wide range of topics related to radiation therapy in patients with cancer that has spread to the brain, including delivery techniques for radiation therapy to manage both unresected and resected brain metastases. The guideline also includes treatment algorithms for limited brain metastases and extensive brain metastases.
Key recommendations are as follows:
For patients with intact/unresected brain metastases:
- SRS is recommended for patients with 1-4 brain metastases and reasonable performance status (ECOG performance status 0-2); SRS is conditionally recommended for those with 5-10 brain metastases and reasonable performance status; for patients with tumors exerting mass effect and/or larger size, multidisciplinary discussion with neurosurgery to consider surgical resection is suggested.
- Upfront local therapy (radiation and/or surgery) is strongly recommended for patients with symptomatic brain metastases.
- For patients with asymptomatic brain metastases who are eligible for central nervous system-directed systemic therapy, multidisciplinary and patient-centered decision-making to determine whether local therapy may be safely deferred is conditionally recommended.
- Whole brain radiation therapy (WBRT) is recommended as a primary treatment for patients with favorable prognosis who have brain metastases that are ineligible for surgery and/or SRS. Hippocampal avoidance (HA) is recommended when appropriate to preserve memory function, as is the addition of memantine to delay neurocognitive decline. Adjuvant WBRT added to SRS routinely is not recommended.
- Supportive care only, without WBRT, should be considered for patients with poor prognosis and brain metastases. Reasonable options for this population include palliative care or hospice, or short-course WBRT for symptomatic brain metastases
- Recommendations also include guidance for SRS and WBRT dosing as well as the use of single-fraction vs hypofractionated SRS. Although SRS use is driven by the number of brain metastases, it is critical that other important factors (eg, total tumor volume and location, patient age, and extracranial disease status) should be taken into consideration during patient-centered decision-making by the multidisciplinary team.
For patients with resected brain metastases:
- Radiation therapy is recommended for all patients after resection in order to improve intracranial control.
- For patients with limited brain metastases after resection, postoperative SRS is recommended over WBRT to preserve the patient’s neurocognitive function and quality of life.
- As a potential alternative to SRS postresection, SRS prior to brain metastasis resection is conditionally recommended.
Updating the guidelines
ASTRO emphasizes that the scope of this paper is limited to the radiotherapeutic management of intact and resected brain metastases resulting from nonhematologic solid tumors. It provides guidance on the reasonable use of modern radiation therapy strategies, including single-fraction and fractionated (ie, hypofractionated SRS) SRS and HA-WBRT, and also discusses clinical considerations in selecting the optimal radiation therapy strategy or in deferring it in favor of best supportive care or close neuro-oncologic surveillance.
The authors note, however, that beyond the scope of this guideline, there are many other important questions that may be the subject of other guidance, such as the appropriate role for CNS-active systemic therapies and/or surgical intervention.
A version of this article was first published on Medscape.com.
“In the decade since the previous ASTRO brain metastases guideline, there has been a tremendous evolution in the way we manage patients’ disease,” said Paul D. Brown, MD, chair of the guideline task force and a professor of radiation oncology at the Mayo Clinic in Rochester, Minn.
“The development of stereotactic radiosurgery (SRS) has allowed treatment of limited brain metastases alone, often in a single fraction, while largely sparing the surrounding brain,” he elaborated in a statement. Also, novel techniques such as hippocampal avoidance with whole-brain radiation can greatly improve quality of life, he added.
The guideline was published May 6 in Practical Radiation Oncology.
“With the emergence of novel radiotherapy techniques and technologies, brain-penetrating drug therapies and neurosurgical interventions, modern management of brain metastases has become increasingly personalized, complex and multidisciplinary,” Vinai Gondi, MD, vice chair of the guideline task force and director of research and education at the Northwestern Medicine Cancer Center and Proton Center in Chicago, said in a statement.
“We developed this guideline to help inform and guide clinicians in patient-centered, multidisciplinary care for their patients with brain metastases,” he added.
Key recommendations
Overall, the recommendations address a wide range of topics related to radiation therapy in patients with cancer that has spread to the brain, including delivery techniques for radiation therapy to manage both unresected and resected brain metastases. The guideline also includes treatment algorithms for limited brain metastases and extensive brain metastases.
Key recommendations are as follows:
For patients with intact/unresected brain metastases:
- SRS is recommended for patients with 1-4 brain metastases and reasonable performance status (ECOG performance status 0-2); SRS is conditionally recommended for those with 5-10 brain metastases and reasonable performance status; for patients with tumors exerting mass effect and/or larger size, multidisciplinary discussion with neurosurgery to consider surgical resection is suggested.
- Upfront local therapy (radiation and/or surgery) is strongly recommended for patients with symptomatic brain metastases.
- For patients with asymptomatic brain metastases who are eligible for central nervous system-directed systemic therapy, multidisciplinary and patient-centered decision-making to determine whether local therapy may be safely deferred is conditionally recommended.
- Whole brain radiation therapy (WBRT) is recommended as a primary treatment for patients with favorable prognosis who have brain metastases that are ineligible for surgery and/or SRS. Hippocampal avoidance (HA) is recommended when appropriate to preserve memory function, as is the addition of memantine to delay neurocognitive decline. Adjuvant WBRT added to SRS routinely is not recommended.
- Supportive care only, without WBRT, should be considered for patients with poor prognosis and brain metastases. Reasonable options for this population include palliative care or hospice, or short-course WBRT for symptomatic brain metastases
- Recommendations also include guidance for SRS and WBRT dosing as well as the use of single-fraction vs hypofractionated SRS. Although SRS use is driven by the number of brain metastases, it is critical that other important factors (eg, total tumor volume and location, patient age, and extracranial disease status) should be taken into consideration during patient-centered decision-making by the multidisciplinary team.
For patients with resected brain metastases:
- Radiation therapy is recommended for all patients after resection in order to improve intracranial control.
- For patients with limited brain metastases after resection, postoperative SRS is recommended over WBRT to preserve the patient’s neurocognitive function and quality of life.
- As a potential alternative to SRS postresection, SRS prior to brain metastasis resection is conditionally recommended.
Updating the guidelines
ASTRO emphasizes that the scope of this paper is limited to the radiotherapeutic management of intact and resected brain metastases resulting from nonhematologic solid tumors. It provides guidance on the reasonable use of modern radiation therapy strategies, including single-fraction and fractionated (ie, hypofractionated SRS) SRS and HA-WBRT, and also discusses clinical considerations in selecting the optimal radiation therapy strategy or in deferring it in favor of best supportive care or close neuro-oncologic surveillance.
The authors note, however, that beyond the scope of this guideline, there are many other important questions that may be the subject of other guidance, such as the appropriate role for CNS-active systemic therapies and/or surgical intervention.
A version of this article was first published on Medscape.com.
“In the decade since the previous ASTRO brain metastases guideline, there has been a tremendous evolution in the way we manage patients’ disease,” said Paul D. Brown, MD, chair of the guideline task force and a professor of radiation oncology at the Mayo Clinic in Rochester, Minn.
“The development of stereotactic radiosurgery (SRS) has allowed treatment of limited brain metastases alone, often in a single fraction, while largely sparing the surrounding brain,” he elaborated in a statement. Also, novel techniques such as hippocampal avoidance with whole-brain radiation can greatly improve quality of life, he added.
The guideline was published May 6 in Practical Radiation Oncology.
“With the emergence of novel radiotherapy techniques and technologies, brain-penetrating drug therapies and neurosurgical interventions, modern management of brain metastases has become increasingly personalized, complex and multidisciplinary,” Vinai Gondi, MD, vice chair of the guideline task force and director of research and education at the Northwestern Medicine Cancer Center and Proton Center in Chicago, said in a statement.
“We developed this guideline to help inform and guide clinicians in patient-centered, multidisciplinary care for their patients with brain metastases,” he added.
Key recommendations
Overall, the recommendations address a wide range of topics related to radiation therapy in patients with cancer that has spread to the brain, including delivery techniques for radiation therapy to manage both unresected and resected brain metastases. The guideline also includes treatment algorithms for limited brain metastases and extensive brain metastases.
Key recommendations are as follows:
For patients with intact/unresected brain metastases:
- SRS is recommended for patients with 1-4 brain metastases and reasonable performance status (ECOG performance status 0-2); SRS is conditionally recommended for those with 5-10 brain metastases and reasonable performance status; for patients with tumors exerting mass effect and/or larger size, multidisciplinary discussion with neurosurgery to consider surgical resection is suggested.
- Upfront local therapy (radiation and/or surgery) is strongly recommended for patients with symptomatic brain metastases.
- For patients with asymptomatic brain metastases who are eligible for central nervous system-directed systemic therapy, multidisciplinary and patient-centered decision-making to determine whether local therapy may be safely deferred is conditionally recommended.
- Whole brain radiation therapy (WBRT) is recommended as a primary treatment for patients with favorable prognosis who have brain metastases that are ineligible for surgery and/or SRS. Hippocampal avoidance (HA) is recommended when appropriate to preserve memory function, as is the addition of memantine to delay neurocognitive decline. Adjuvant WBRT added to SRS routinely is not recommended.
- Supportive care only, without WBRT, should be considered for patients with poor prognosis and brain metastases. Reasonable options for this population include palliative care or hospice, or short-course WBRT for symptomatic brain metastases
- Recommendations also include guidance for SRS and WBRT dosing as well as the use of single-fraction vs hypofractionated SRS. Although SRS use is driven by the number of brain metastases, it is critical that other important factors (eg, total tumor volume and location, patient age, and extracranial disease status) should be taken into consideration during patient-centered decision-making by the multidisciplinary team.
For patients with resected brain metastases:
- Radiation therapy is recommended for all patients after resection in order to improve intracranial control.
- For patients with limited brain metastases after resection, postoperative SRS is recommended over WBRT to preserve the patient’s neurocognitive function and quality of life.
- As a potential alternative to SRS postresection, SRS prior to brain metastasis resection is conditionally recommended.
Updating the guidelines
ASTRO emphasizes that the scope of this paper is limited to the radiotherapeutic management of intact and resected brain metastases resulting from nonhematologic solid tumors. It provides guidance on the reasonable use of modern radiation therapy strategies, including single-fraction and fractionated (ie, hypofractionated SRS) SRS and HA-WBRT, and also discusses clinical considerations in selecting the optimal radiation therapy strategy or in deferring it in favor of best supportive care or close neuro-oncologic surveillance.
The authors note, however, that beyond the scope of this guideline, there are many other important questions that may be the subject of other guidance, such as the appropriate role for CNS-active systemic therapies and/or surgical intervention.
A version of this article was first published on Medscape.com.
FROM PRACTICAL RADIATION ONCOLOGY
‘Extremely exciting’ study results guide MM treatment options
CHICAGO – New results from a trial in patients with newly diagnosed multiple myeloma (MM) offer some answers to questions about which treatment route to choose.
Patients who received the triplet of lenalidomide, bortezomib, and dexamethasone (RVD) plus ASCT had a median PFS of 67.5 months, compared with 46.2 months for those who received RVD but did not have a transplant soon after.
However, patients were just as likely to be alive more than 6 years after treatment regardless of whether or not they underwent an immediate stem cell transplant.
In addition, treatment-related adverse events of grade 3 or above were higher in the group that received the transplant immediately after the triplet therapy.
The results were presented during a plenary session at the American Society of Clinical Oncology annual meeting and simultaneously published in the New England Journal of Medicine.
“Our findings confirm the PFS benefit of transplantation as first-line treatment for patients with myeloma and confirms stem cell transplant as a standard of care with certain triplet therapy,” said lead author Paul G. Richardson, MD, professor of medicine, Harvard Medical School, and clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana Farber Cancer Institute, Boston.
Another finding from the trial was that the use of maintenance lenalidomide in both groups continuously until progression conferred substantial clinical benefit.
“We can also say that the use of lenalidomide maintenance therapy is also a standard of care,” he added.
Study details
In this trial, Dr. Richardson and colleagues randomly assigned 873 patients newly diagnosed with multiple myeloma to the RVD-alone group (n = 357) or the transplantation group (n = 365). All patients had received one cycle of RVD prior to randomization and then received two additional RVD cycles plus stem-cell mobilization followed by either five additional RVD cycles (the RVD-alone group) or high-dose melphalan plus ASCT followed by two additional RVD cycles (the transplantation group). Lenalidomide was administered to all patients until disease progression, unacceptable side effects, or both.
At a median follow-up of 76.0 months, the risk of disease progression or death was 53% higher among patients who received RVD alone versus the transplantation group (hazard ratio [HR], 1.53; P < .001). The median duration of PFS among patients with a high-risk cytogenetic profile was 55.5 vs. 17.1 months, favoring the transplantation group.
The percentage of patients who were alive without progression at 5 years was 58.4% vs 41.6%, respectively (HR, 1.66) and median duration of response was 56.4 vs 38.9 months, also favoring transplantation (HR, 1.45).
The estimated 5-year overall survival was similar between groups: 80.7% for transplantation and 79.2% for RVD alone (HR for death, 1.10; P > .99). For patients with a high-risk cytogenetic profile, 5-year survival was 63.4% versus 54.3%, respectively.
“This tells us that for patients who had kept transplant in reserve, they had the same overall survival as those who had had a transplant right away, despite there being such impressive initial disease control for the patients in whom transplant was used early,” Dr. Richardson said in a press release from his institution.
Patients who did not undergo immediate transplant received treatment when their disease progressed with newer and active therapies, such as monoclonal antibodies and/or next-generation novel agents, he noted. Only 28% of patients used the reserve option of a transplant.
“It demonstrates the extent to which patients now have options and that we have new data to guide them in balancing the pluses and minuses of each approach,” he added.
When looking at safety, the authors noted that the most common treatment-related adverse events of grade 3 or higher occurred in 279 patients (78.2%) in the RVD-alone group and 344 patients (94.2%) in the transplantation group. Of those patients, 60.5% and 89.9%, respectively, reported hematologic events of grade 3 or higher (P < .001). The 5-year cumulative incidence of invasive second primary cancers was similar in both cohorts (RVD-alone group, 4.9%; transplantation group, 6.5%).
However, while the risk of secondary cancers was similar between groups, Dr. Richardson noted that there was a higher incidence of acute myeloid leukemia and myelodysplastic syndromes in the transplant cohort.
“There was also a significant drop in quality of life across transplant procedures, but the good news is that it was recoverable rapidly,” he said. “What is also really important is that we have prospective, multicenter, national comparative data on toxicity. That’s very important for providing patients with a choice as they move forward with their treatment plan.”
He noted that treatment continues to evolve. “This study was designed in 2009, begun in 2010, and now there is mature data in 2022,” Dr. Richardson said. “This is particularly relevant as we have now further improved the induction treatment for younger patients with newly diagnosed myeloma using quadruplet regimens incorporating monoclonal antibodies and novel next-generation therapies. The results from these studies are extremely exciting.
“Now more than ever, treatment for multiple myeloma can be adapted for each patient,” Dr. Richardson said. “Our study provides important information about the benefits of transplant in the era of highly effective novel therapies and continuous maintenance, as well as the potential risks, to help patients and their physicians decide what approach may be best for them. This is particularly relevant as we have now further improved the induction treatment for younger patients with newly diagnosed myeloma using quadruplet regimens incorporating monoclonal antibodies, such as RVD combined with daratumumab.”
Lack of difference in overall survival
These new results further support an already established role of autologous hematopoietic stem cell transplantation in the management of patients with multiple myeloma, said Samer Al-Homsi, MD, clinical professor of medicine and director of the blood and marrow transplant program at Perlmutter Cancer Center, NYU Langone, New York, who was approached for comment.
“The treatment regimen is applicable to patients who are determined by an expert in transplantation to be fit to receive autologous hematopoietic transplantation,” he added. “Although this study, like many others, establishes hematopoietic stem cell transplantation as part of the standard of care in multiple myeloma, only a fraction of patients are actually offered this important modality of treatment for a variety of reasons, including provider bias,” he noted. “In fact, although improvement in supportive care has enhanced the safety of the procedure, many patients are denied this therapy.”
Dr. Al-Homsi noted that the lack of difference in overall survival might be due to the fact that some patients (28%) in the RVD-alone group did end up undergoing transplantation at the time of progression. “Also, longer follow-up might reveal a difference in overall survival,” he said.
The toxicities are manageable, and the incidence of secondary malignancies was not significantly different between cohorts. “However,” he emphasized, “lenalidomide has been associated in other studies with increased incidence of secondary malignancies and it must be noted that this study used extended administration of lenalidomide until progression.”
Support for this study was provided by grants to the Blood and Marrow Transplant Clinical Trials Network from the National Heart, Lung, and Blood Institute, the National Cancer Institute, R. J. Corman Multiple Myeloma Foundation, Celgene/Bristol Myers Squibb, and Millennium/Takeda Pharmaceutical. Dr. Richardson has reported relationships with Celgene, Janssen, Jazz Pharmaceuticals, Karyopharm Therapeutics, Oncopeptides, Sanofi, Secura Bio, Takeda, and Bristol Myers Squibb. Dr. Al-Homsi has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – New results from a trial in patients with newly diagnosed multiple myeloma (MM) offer some answers to questions about which treatment route to choose.
Patients who received the triplet of lenalidomide, bortezomib, and dexamethasone (RVD) plus ASCT had a median PFS of 67.5 months, compared with 46.2 months for those who received RVD but did not have a transplant soon after.
However, patients were just as likely to be alive more than 6 years after treatment regardless of whether or not they underwent an immediate stem cell transplant.
In addition, treatment-related adverse events of grade 3 or above were higher in the group that received the transplant immediately after the triplet therapy.
The results were presented during a plenary session at the American Society of Clinical Oncology annual meeting and simultaneously published in the New England Journal of Medicine.
“Our findings confirm the PFS benefit of transplantation as first-line treatment for patients with myeloma and confirms stem cell transplant as a standard of care with certain triplet therapy,” said lead author Paul G. Richardson, MD, professor of medicine, Harvard Medical School, and clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana Farber Cancer Institute, Boston.
Another finding from the trial was that the use of maintenance lenalidomide in both groups continuously until progression conferred substantial clinical benefit.
“We can also say that the use of lenalidomide maintenance therapy is also a standard of care,” he added.
Study details
In this trial, Dr. Richardson and colleagues randomly assigned 873 patients newly diagnosed with multiple myeloma to the RVD-alone group (n = 357) or the transplantation group (n = 365). All patients had received one cycle of RVD prior to randomization and then received two additional RVD cycles plus stem-cell mobilization followed by either five additional RVD cycles (the RVD-alone group) or high-dose melphalan plus ASCT followed by two additional RVD cycles (the transplantation group). Lenalidomide was administered to all patients until disease progression, unacceptable side effects, or both.
At a median follow-up of 76.0 months, the risk of disease progression or death was 53% higher among patients who received RVD alone versus the transplantation group (hazard ratio [HR], 1.53; P < .001). The median duration of PFS among patients with a high-risk cytogenetic profile was 55.5 vs. 17.1 months, favoring the transplantation group.
The percentage of patients who were alive without progression at 5 years was 58.4% vs 41.6%, respectively (HR, 1.66) and median duration of response was 56.4 vs 38.9 months, also favoring transplantation (HR, 1.45).
The estimated 5-year overall survival was similar between groups: 80.7% for transplantation and 79.2% for RVD alone (HR for death, 1.10; P > .99). For patients with a high-risk cytogenetic profile, 5-year survival was 63.4% versus 54.3%, respectively.
“This tells us that for patients who had kept transplant in reserve, they had the same overall survival as those who had had a transplant right away, despite there being such impressive initial disease control for the patients in whom transplant was used early,” Dr. Richardson said in a press release from his institution.
Patients who did not undergo immediate transplant received treatment when their disease progressed with newer and active therapies, such as monoclonal antibodies and/or next-generation novel agents, he noted. Only 28% of patients used the reserve option of a transplant.
“It demonstrates the extent to which patients now have options and that we have new data to guide them in balancing the pluses and minuses of each approach,” he added.
When looking at safety, the authors noted that the most common treatment-related adverse events of grade 3 or higher occurred in 279 patients (78.2%) in the RVD-alone group and 344 patients (94.2%) in the transplantation group. Of those patients, 60.5% and 89.9%, respectively, reported hematologic events of grade 3 or higher (P < .001). The 5-year cumulative incidence of invasive second primary cancers was similar in both cohorts (RVD-alone group, 4.9%; transplantation group, 6.5%).
However, while the risk of secondary cancers was similar between groups, Dr. Richardson noted that there was a higher incidence of acute myeloid leukemia and myelodysplastic syndromes in the transplant cohort.
“There was also a significant drop in quality of life across transplant procedures, but the good news is that it was recoverable rapidly,” he said. “What is also really important is that we have prospective, multicenter, national comparative data on toxicity. That’s very important for providing patients with a choice as they move forward with their treatment plan.”
He noted that treatment continues to evolve. “This study was designed in 2009, begun in 2010, and now there is mature data in 2022,” Dr. Richardson said. “This is particularly relevant as we have now further improved the induction treatment for younger patients with newly diagnosed myeloma using quadruplet regimens incorporating monoclonal antibodies and novel next-generation therapies. The results from these studies are extremely exciting.
“Now more than ever, treatment for multiple myeloma can be adapted for each patient,” Dr. Richardson said. “Our study provides important information about the benefits of transplant in the era of highly effective novel therapies and continuous maintenance, as well as the potential risks, to help patients and their physicians decide what approach may be best for them. This is particularly relevant as we have now further improved the induction treatment for younger patients with newly diagnosed myeloma using quadruplet regimens incorporating monoclonal antibodies, such as RVD combined with daratumumab.”
Lack of difference in overall survival
These new results further support an already established role of autologous hematopoietic stem cell transplantation in the management of patients with multiple myeloma, said Samer Al-Homsi, MD, clinical professor of medicine and director of the blood and marrow transplant program at Perlmutter Cancer Center, NYU Langone, New York, who was approached for comment.
“The treatment regimen is applicable to patients who are determined by an expert in transplantation to be fit to receive autologous hematopoietic transplantation,” he added. “Although this study, like many others, establishes hematopoietic stem cell transplantation as part of the standard of care in multiple myeloma, only a fraction of patients are actually offered this important modality of treatment for a variety of reasons, including provider bias,” he noted. “In fact, although improvement in supportive care has enhanced the safety of the procedure, many patients are denied this therapy.”
Dr. Al-Homsi noted that the lack of difference in overall survival might be due to the fact that some patients (28%) in the RVD-alone group did end up undergoing transplantation at the time of progression. “Also, longer follow-up might reveal a difference in overall survival,” he said.
The toxicities are manageable, and the incidence of secondary malignancies was not significantly different between cohorts. “However,” he emphasized, “lenalidomide has been associated in other studies with increased incidence of secondary malignancies and it must be noted that this study used extended administration of lenalidomide until progression.”
Support for this study was provided by grants to the Blood and Marrow Transplant Clinical Trials Network from the National Heart, Lung, and Blood Institute, the National Cancer Institute, R. J. Corman Multiple Myeloma Foundation, Celgene/Bristol Myers Squibb, and Millennium/Takeda Pharmaceutical. Dr. Richardson has reported relationships with Celgene, Janssen, Jazz Pharmaceuticals, Karyopharm Therapeutics, Oncopeptides, Sanofi, Secura Bio, Takeda, and Bristol Myers Squibb. Dr. Al-Homsi has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – New results from a trial in patients with newly diagnosed multiple myeloma (MM) offer some answers to questions about which treatment route to choose.
Patients who received the triplet of lenalidomide, bortezomib, and dexamethasone (RVD) plus ASCT had a median PFS of 67.5 months, compared with 46.2 months for those who received RVD but did not have a transplant soon after.
However, patients were just as likely to be alive more than 6 years after treatment regardless of whether or not they underwent an immediate stem cell transplant.
In addition, treatment-related adverse events of grade 3 or above were higher in the group that received the transplant immediately after the triplet therapy.
The results were presented during a plenary session at the American Society of Clinical Oncology annual meeting and simultaneously published in the New England Journal of Medicine.
“Our findings confirm the PFS benefit of transplantation as first-line treatment for patients with myeloma and confirms stem cell transplant as a standard of care with certain triplet therapy,” said lead author Paul G. Richardson, MD, professor of medicine, Harvard Medical School, and clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana Farber Cancer Institute, Boston.
Another finding from the trial was that the use of maintenance lenalidomide in both groups continuously until progression conferred substantial clinical benefit.
“We can also say that the use of lenalidomide maintenance therapy is also a standard of care,” he added.
Study details
In this trial, Dr. Richardson and colleagues randomly assigned 873 patients newly diagnosed with multiple myeloma to the RVD-alone group (n = 357) or the transplantation group (n = 365). All patients had received one cycle of RVD prior to randomization and then received two additional RVD cycles plus stem-cell mobilization followed by either five additional RVD cycles (the RVD-alone group) or high-dose melphalan plus ASCT followed by two additional RVD cycles (the transplantation group). Lenalidomide was administered to all patients until disease progression, unacceptable side effects, or both.
At a median follow-up of 76.0 months, the risk of disease progression or death was 53% higher among patients who received RVD alone versus the transplantation group (hazard ratio [HR], 1.53; P < .001). The median duration of PFS among patients with a high-risk cytogenetic profile was 55.5 vs. 17.1 months, favoring the transplantation group.
The percentage of patients who were alive without progression at 5 years was 58.4% vs 41.6%, respectively (HR, 1.66) and median duration of response was 56.4 vs 38.9 months, also favoring transplantation (HR, 1.45).
The estimated 5-year overall survival was similar between groups: 80.7% for transplantation and 79.2% for RVD alone (HR for death, 1.10; P > .99). For patients with a high-risk cytogenetic profile, 5-year survival was 63.4% versus 54.3%, respectively.
“This tells us that for patients who had kept transplant in reserve, they had the same overall survival as those who had had a transplant right away, despite there being such impressive initial disease control for the patients in whom transplant was used early,” Dr. Richardson said in a press release from his institution.
Patients who did not undergo immediate transplant received treatment when their disease progressed with newer and active therapies, such as monoclonal antibodies and/or next-generation novel agents, he noted. Only 28% of patients used the reserve option of a transplant.
“It demonstrates the extent to which patients now have options and that we have new data to guide them in balancing the pluses and minuses of each approach,” he added.
When looking at safety, the authors noted that the most common treatment-related adverse events of grade 3 or higher occurred in 279 patients (78.2%) in the RVD-alone group and 344 patients (94.2%) in the transplantation group. Of those patients, 60.5% and 89.9%, respectively, reported hematologic events of grade 3 or higher (P < .001). The 5-year cumulative incidence of invasive second primary cancers was similar in both cohorts (RVD-alone group, 4.9%; transplantation group, 6.5%).
However, while the risk of secondary cancers was similar between groups, Dr. Richardson noted that there was a higher incidence of acute myeloid leukemia and myelodysplastic syndromes in the transplant cohort.
“There was also a significant drop in quality of life across transplant procedures, but the good news is that it was recoverable rapidly,” he said. “What is also really important is that we have prospective, multicenter, national comparative data on toxicity. That’s very important for providing patients with a choice as they move forward with their treatment plan.”
He noted that treatment continues to evolve. “This study was designed in 2009, begun in 2010, and now there is mature data in 2022,” Dr. Richardson said. “This is particularly relevant as we have now further improved the induction treatment for younger patients with newly diagnosed myeloma using quadruplet regimens incorporating monoclonal antibodies and novel next-generation therapies. The results from these studies are extremely exciting.
“Now more than ever, treatment for multiple myeloma can be adapted for each patient,” Dr. Richardson said. “Our study provides important information about the benefits of transplant in the era of highly effective novel therapies and continuous maintenance, as well as the potential risks, to help patients and their physicians decide what approach may be best for them. This is particularly relevant as we have now further improved the induction treatment for younger patients with newly diagnosed myeloma using quadruplet regimens incorporating monoclonal antibodies, such as RVD combined with daratumumab.”
Lack of difference in overall survival
These new results further support an already established role of autologous hematopoietic stem cell transplantation in the management of patients with multiple myeloma, said Samer Al-Homsi, MD, clinical professor of medicine and director of the blood and marrow transplant program at Perlmutter Cancer Center, NYU Langone, New York, who was approached for comment.
“The treatment regimen is applicable to patients who are determined by an expert in transplantation to be fit to receive autologous hematopoietic transplantation,” he added. “Although this study, like many others, establishes hematopoietic stem cell transplantation as part of the standard of care in multiple myeloma, only a fraction of patients are actually offered this important modality of treatment for a variety of reasons, including provider bias,” he noted. “In fact, although improvement in supportive care has enhanced the safety of the procedure, many patients are denied this therapy.”
Dr. Al-Homsi noted that the lack of difference in overall survival might be due to the fact that some patients (28%) in the RVD-alone group did end up undergoing transplantation at the time of progression. “Also, longer follow-up might reveal a difference in overall survival,” he said.
The toxicities are manageable, and the incidence of secondary malignancies was not significantly different between cohorts. “However,” he emphasized, “lenalidomide has been associated in other studies with increased incidence of secondary malignancies and it must be noted that this study used extended administration of lenalidomide until progression.”
Support for this study was provided by grants to the Blood and Marrow Transplant Clinical Trials Network from the National Heart, Lung, and Blood Institute, the National Cancer Institute, R. J. Corman Multiple Myeloma Foundation, Celgene/Bristol Myers Squibb, and Millennium/Takeda Pharmaceutical. Dr. Richardson has reported relationships with Celgene, Janssen, Jazz Pharmaceuticals, Karyopharm Therapeutics, Oncopeptides, Sanofi, Secura Bio, Takeda, and Bristol Myers Squibb. Dr. Al-Homsi has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ASCO 2022
FDA denies petition to disqualify researchers over controversial ketamine studies
The U.S. Food and Drug Administration has declined to take further action against a group of investigators at Hennepin County Medical Center/Hennepin Healthcare (HCMC) who conducted controversial studies involving ketamine and other sedatives on agitated persons without their consent.
A citizen petition filed by Public Citizen, a consumer advocacy group, had asked the FDA to initiate clinical-investigator disqualification proceedings against Jon Cole, MD, and Lauren Klein, MD, along with other researchers who participated in the studies, for “repeatedly and deliberately initiating and conducting clinical investigations of investigational drug products” without having submitted or having in effect the investigational new drug applications (INDs) required by the FDA.
In certain situations, wherein the FDA alleges that a clinical investigator has violated applicable regulations, the agency may initiate clinical investigator disqualification proceedings. The names of the disqualified researchers are then added to a federal database.
The petition, which was filed in November 2021, also requested that the FDA initiate disqualification proceedings against the institutional review board (IRB) at HCMC for repeatedly failing to comply with federal regulations that adversely affected the rights and welfare of the individuals who were enrolled in the study without their consent.
Of note, Public Citizen stated that the FDA should have required the hospital to contact the more than 1,700 patients who “were unwittingly enrolled in unethical experiments” and inform them that their rights had been violated and their health potentially endangered by the research team.
Michael A. Carome, MD, director of Public Citizen’s Health Research Group, told this news organization that it is uncommon for the FDA to disqualify researchers. “It should be more common than it is,” he said. “I think that FDA is just reluctant to take more action.”
The actions of the Hennepin investigators were “repetitive and appeared to be in deliberate violation of regulations,” he added. “The case for the FDA disqualifying the HCMC researchers is overwhelming. The FDA’s slap-on-the-wrist approach to such appalling regulatory and ethical violations risks emboldening other researchers to disregard the rights and welfare of human subjects.”
Carl Elliott, MD, PhD, a bioethicist at the University of Minnesota, Minneapolis, agrees that the researcher from HCMC should be disqualified. “They didn’t just conduct risky, exploitative studies – they conducted them after the FDA had warned them not to proceed,” he said. “The message sent by this slap on the wrist is that investigators can do whatever they want to nonconsenting subjects, and the FDA will look the other way.”
Initial complaint
Public Citizen initially filed a complaint with the FDA in 2018, after learning that researchers affiliated with HCMC were conducting high-risk clinical trials involving ketamine to control agitation outside of the hospital setting. The complaint was cosigned by 64 doctors, bioethicists, and academic researchers and was also submitted to the Office for Human Research Protections.
The FDA typically allows investigational drugs to be used in emergency situation without obtaining informed consent if the therapies are known to carry a minimal risk. The IRB at HCMC had determined that this was the case with ketamine and approved the trials.
But according to Public Citizen’s complaint, prior research had suggested that ketamine could cause more complications and severe adverse events, compared with other sedatives.
The trials were conducted between 2014 and 2018, and in its letter, Public Citizen alleged that the investigators and the IRB had allowed these trials to proceed without obtaining informed consent from patients. The goal was to evaluate how well ketamine worked, compared with other drugs in calming agitated individuals: “The patients were given either ketamine or haloperidol for agitation by paramedics who responded to medical emergencies, and the goal was to see which drug worked faster,” said Dr. Carome. “Patients were only notified afterwards that they had received a sedative. Informed consent had been waived by IRB.”
In the first clinical trial conducted by HCMC, published in 2016, the researchers had hypothesized that 5 mg/kg of intramuscular ketamine would be superior to 10 mg of intramuscular haloperidol for severe prehospital agitation. Time to adequate sedation was the primary outcome measure. The study included 146 people; 64 received ketamine and 82 received haloperidol. They found that ketamine worked far more quickly than haloperidol (5 minutes vs. 17 minutes) but that the risk for complications was much higher. Complications occurred in 49% of patients receiving ketamine, compared with 5%.
“There was a 10-fold risk of adverse events,” said Dr. Carome. “And 39% of patients given ketamine had respiratory problems requiring intubation, compared to 4% who received haloperidol.”
A second study was launched in 2017, wherein ketamine was compared with midazolam in agitated patients. During the first 6-month period of the study, individuals would receive a ketamine-based protocol for prehospital agitation, and during the second 6 months, that would switch to midazolam. However, the study was halted in June 2018 after the local newspaper, the Star Tribune, reported that the city police had encouraged medical personnel to sedate agitated patients. This included individuals who had already been physically restrained.
The report stated that “in many cases, the individual being detained or arrested was not only handcuffed but strapped down on a stretcher in an ambulance before receiving ketamine,” and that it raised a “concerning question” over why these people were given the drug before they were transported to the hospital, “given the immediate effects on breathing and heart function that the drug induces.”
Along with halting the trial, HCMC asked for a review of cases involving its paramedics; an independent investigation led by former U.S. Deputy Attorney General Sally Yates was initiated to assess whether the Minneapolis police had crossed a line and urged paramedics to use ketamine.
“The decision to use ketamine was based on the study’s timeline and not on clinical judgment,” said Dr. Carome.
The FDA acknowledged receipt of the complaint and inspected the IRB records and the clinical trial data. Preliminary reports received by Public Citizen confirmed their allegations. “There were not appropriate protections for vulnerable subjects,” he said. “In 2019, the FDA did further investigations, and those reports had similar findings.”
FDA letters
The FDA had sent warning letters to Dr. Cole and Dr. Klein, citing them for ignoring federal safety laws in experimental research on the public. In their investigations, the FDA cited “objectionable conditions” for the studies led by Dr. Cole and Dr. Klein, according to the letters. Both researchers seemingly ignored FDA regulations and used practices that subjected patients to “significantly increased risk,” and the hospital defended its research with “factually incorrect” statements.
In a letter to Dr. Cole, the FDA noted that he never filed INDs for the trials with the FDA, as required by law, and that he also failed to write appropriate protocols to ensure that children and pregnant women were not enrolled in the research. Individuals under the influence of intoxicants also were not excluded, though the use of ketamine is cautioned in this population.
“Administration of the investigational drugs to these subjects placed them at significantly increased risk of the adverse events associated with the investigational products and decreased the acceptability of those risks,” the FDA said in its letter. “Your failure to exclude, and the lack of any precautions for, subjects under the influence of various intoxicants significantly increased the risks and/or decreased the acceptability of the risks associated with the investigational drugs.”
However, Dr. Cole conducted both studies in the prehospital setting and failed to initiate any specific measures to protect study participants, according to the FDA.
Petition denied
Dr. Carome noted that the researchers had committed repetitive egregious regulatory violations over a 4-year period, which were documented by the FDA in their warning letters to Dr. Cole and Dr. Klein. “We felt that they were so egregious that we need to send a signal to the community that this sort of behavior will not be tolerated,” he said. “The FDA denied our petition, and we think that sends the wrong signal to the research community.”
In their response, the FDA noted that as with judicial enforcement, “the Agency makes decisions regarding whether to pursue administrative enforcement action, including disqualification proceedings, on a case-by-case basis, considering all relevant facts and circumstances.” They added that at this time, they would not be taking further action against Dr. Cole and Dr. Klein.
“However, we intend to continue to consider all the options available to the Agency as we determine whether to pursue additional compliance actions related to this matter,” the FDA concluded.
The FDA declined to comment further on their decision.
Dr. Cole also declined to comment, but Hennepin Healthcare told this news organization that the “decision by the FDA to deny the petition validates the changes we made to strengthen and improve the clinical research program across the institution since the closing of the studies in 2018. We look forward to continuing to work with the FDA to ensure full compliance with the standards in place to protect research subjects.”
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has declined to take further action against a group of investigators at Hennepin County Medical Center/Hennepin Healthcare (HCMC) who conducted controversial studies involving ketamine and other sedatives on agitated persons without their consent.
A citizen petition filed by Public Citizen, a consumer advocacy group, had asked the FDA to initiate clinical-investigator disqualification proceedings against Jon Cole, MD, and Lauren Klein, MD, along with other researchers who participated in the studies, for “repeatedly and deliberately initiating and conducting clinical investigations of investigational drug products” without having submitted or having in effect the investigational new drug applications (INDs) required by the FDA.
In certain situations, wherein the FDA alleges that a clinical investigator has violated applicable regulations, the agency may initiate clinical investigator disqualification proceedings. The names of the disqualified researchers are then added to a federal database.
The petition, which was filed in November 2021, also requested that the FDA initiate disqualification proceedings against the institutional review board (IRB) at HCMC for repeatedly failing to comply with federal regulations that adversely affected the rights and welfare of the individuals who were enrolled in the study without their consent.
Of note, Public Citizen stated that the FDA should have required the hospital to contact the more than 1,700 patients who “were unwittingly enrolled in unethical experiments” and inform them that their rights had been violated and their health potentially endangered by the research team.
Michael A. Carome, MD, director of Public Citizen’s Health Research Group, told this news organization that it is uncommon for the FDA to disqualify researchers. “It should be more common than it is,” he said. “I think that FDA is just reluctant to take more action.”
The actions of the Hennepin investigators were “repetitive and appeared to be in deliberate violation of regulations,” he added. “The case for the FDA disqualifying the HCMC researchers is overwhelming. The FDA’s slap-on-the-wrist approach to such appalling regulatory and ethical violations risks emboldening other researchers to disregard the rights and welfare of human subjects.”
Carl Elliott, MD, PhD, a bioethicist at the University of Minnesota, Minneapolis, agrees that the researcher from HCMC should be disqualified. “They didn’t just conduct risky, exploitative studies – they conducted them after the FDA had warned them not to proceed,” he said. “The message sent by this slap on the wrist is that investigators can do whatever they want to nonconsenting subjects, and the FDA will look the other way.”
Initial complaint
Public Citizen initially filed a complaint with the FDA in 2018, after learning that researchers affiliated with HCMC were conducting high-risk clinical trials involving ketamine to control agitation outside of the hospital setting. The complaint was cosigned by 64 doctors, bioethicists, and academic researchers and was also submitted to the Office for Human Research Protections.
The FDA typically allows investigational drugs to be used in emergency situation without obtaining informed consent if the therapies are known to carry a minimal risk. The IRB at HCMC had determined that this was the case with ketamine and approved the trials.
But according to Public Citizen’s complaint, prior research had suggested that ketamine could cause more complications and severe adverse events, compared with other sedatives.
The trials were conducted between 2014 and 2018, and in its letter, Public Citizen alleged that the investigators and the IRB had allowed these trials to proceed without obtaining informed consent from patients. The goal was to evaluate how well ketamine worked, compared with other drugs in calming agitated individuals: “The patients were given either ketamine or haloperidol for agitation by paramedics who responded to medical emergencies, and the goal was to see which drug worked faster,” said Dr. Carome. “Patients were only notified afterwards that they had received a sedative. Informed consent had been waived by IRB.”
In the first clinical trial conducted by HCMC, published in 2016, the researchers had hypothesized that 5 mg/kg of intramuscular ketamine would be superior to 10 mg of intramuscular haloperidol for severe prehospital agitation. Time to adequate sedation was the primary outcome measure. The study included 146 people; 64 received ketamine and 82 received haloperidol. They found that ketamine worked far more quickly than haloperidol (5 minutes vs. 17 minutes) but that the risk for complications was much higher. Complications occurred in 49% of patients receiving ketamine, compared with 5%.
“There was a 10-fold risk of adverse events,” said Dr. Carome. “And 39% of patients given ketamine had respiratory problems requiring intubation, compared to 4% who received haloperidol.”
A second study was launched in 2017, wherein ketamine was compared with midazolam in agitated patients. During the first 6-month period of the study, individuals would receive a ketamine-based protocol for prehospital agitation, and during the second 6 months, that would switch to midazolam. However, the study was halted in June 2018 after the local newspaper, the Star Tribune, reported that the city police had encouraged medical personnel to sedate agitated patients. This included individuals who had already been physically restrained.
The report stated that “in many cases, the individual being detained or arrested was not only handcuffed but strapped down on a stretcher in an ambulance before receiving ketamine,” and that it raised a “concerning question” over why these people were given the drug before they were transported to the hospital, “given the immediate effects on breathing and heart function that the drug induces.”
Along with halting the trial, HCMC asked for a review of cases involving its paramedics; an independent investigation led by former U.S. Deputy Attorney General Sally Yates was initiated to assess whether the Minneapolis police had crossed a line and urged paramedics to use ketamine.
“The decision to use ketamine was based on the study’s timeline and not on clinical judgment,” said Dr. Carome.
The FDA acknowledged receipt of the complaint and inspected the IRB records and the clinical trial data. Preliminary reports received by Public Citizen confirmed their allegations. “There were not appropriate protections for vulnerable subjects,” he said. “In 2019, the FDA did further investigations, and those reports had similar findings.”
FDA letters
The FDA had sent warning letters to Dr. Cole and Dr. Klein, citing them for ignoring federal safety laws in experimental research on the public. In their investigations, the FDA cited “objectionable conditions” for the studies led by Dr. Cole and Dr. Klein, according to the letters. Both researchers seemingly ignored FDA regulations and used practices that subjected patients to “significantly increased risk,” and the hospital defended its research with “factually incorrect” statements.
In a letter to Dr. Cole, the FDA noted that he never filed INDs for the trials with the FDA, as required by law, and that he also failed to write appropriate protocols to ensure that children and pregnant women were not enrolled in the research. Individuals under the influence of intoxicants also were not excluded, though the use of ketamine is cautioned in this population.
“Administration of the investigational drugs to these subjects placed them at significantly increased risk of the adverse events associated with the investigational products and decreased the acceptability of those risks,” the FDA said in its letter. “Your failure to exclude, and the lack of any precautions for, subjects under the influence of various intoxicants significantly increased the risks and/or decreased the acceptability of the risks associated with the investigational drugs.”
However, Dr. Cole conducted both studies in the prehospital setting and failed to initiate any specific measures to protect study participants, according to the FDA.
Petition denied
Dr. Carome noted that the researchers had committed repetitive egregious regulatory violations over a 4-year period, which were documented by the FDA in their warning letters to Dr. Cole and Dr. Klein. “We felt that they were so egregious that we need to send a signal to the community that this sort of behavior will not be tolerated,” he said. “The FDA denied our petition, and we think that sends the wrong signal to the research community.”
In their response, the FDA noted that as with judicial enforcement, “the Agency makes decisions regarding whether to pursue administrative enforcement action, including disqualification proceedings, on a case-by-case basis, considering all relevant facts and circumstances.” They added that at this time, they would not be taking further action against Dr. Cole and Dr. Klein.
“However, we intend to continue to consider all the options available to the Agency as we determine whether to pursue additional compliance actions related to this matter,” the FDA concluded.
The FDA declined to comment further on their decision.
Dr. Cole also declined to comment, but Hennepin Healthcare told this news organization that the “decision by the FDA to deny the petition validates the changes we made to strengthen and improve the clinical research program across the institution since the closing of the studies in 2018. We look forward to continuing to work with the FDA to ensure full compliance with the standards in place to protect research subjects.”
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has declined to take further action against a group of investigators at Hennepin County Medical Center/Hennepin Healthcare (HCMC) who conducted controversial studies involving ketamine and other sedatives on agitated persons without their consent.
A citizen petition filed by Public Citizen, a consumer advocacy group, had asked the FDA to initiate clinical-investigator disqualification proceedings against Jon Cole, MD, and Lauren Klein, MD, along with other researchers who participated in the studies, for “repeatedly and deliberately initiating and conducting clinical investigations of investigational drug products” without having submitted or having in effect the investigational new drug applications (INDs) required by the FDA.
In certain situations, wherein the FDA alleges that a clinical investigator has violated applicable regulations, the agency may initiate clinical investigator disqualification proceedings. The names of the disqualified researchers are then added to a federal database.
The petition, which was filed in November 2021, also requested that the FDA initiate disqualification proceedings against the institutional review board (IRB) at HCMC for repeatedly failing to comply with federal regulations that adversely affected the rights and welfare of the individuals who were enrolled in the study without their consent.
Of note, Public Citizen stated that the FDA should have required the hospital to contact the more than 1,700 patients who “were unwittingly enrolled in unethical experiments” and inform them that their rights had been violated and their health potentially endangered by the research team.
Michael A. Carome, MD, director of Public Citizen’s Health Research Group, told this news organization that it is uncommon for the FDA to disqualify researchers. “It should be more common than it is,” he said. “I think that FDA is just reluctant to take more action.”
The actions of the Hennepin investigators were “repetitive and appeared to be in deliberate violation of regulations,” he added. “The case for the FDA disqualifying the HCMC researchers is overwhelming. The FDA’s slap-on-the-wrist approach to such appalling regulatory and ethical violations risks emboldening other researchers to disregard the rights and welfare of human subjects.”
Carl Elliott, MD, PhD, a bioethicist at the University of Minnesota, Minneapolis, agrees that the researcher from HCMC should be disqualified. “They didn’t just conduct risky, exploitative studies – they conducted them after the FDA had warned them not to proceed,” he said. “The message sent by this slap on the wrist is that investigators can do whatever they want to nonconsenting subjects, and the FDA will look the other way.”
Initial complaint
Public Citizen initially filed a complaint with the FDA in 2018, after learning that researchers affiliated with HCMC were conducting high-risk clinical trials involving ketamine to control agitation outside of the hospital setting. The complaint was cosigned by 64 doctors, bioethicists, and academic researchers and was also submitted to the Office for Human Research Protections.
The FDA typically allows investigational drugs to be used in emergency situation without obtaining informed consent if the therapies are known to carry a minimal risk. The IRB at HCMC had determined that this was the case with ketamine and approved the trials.
But according to Public Citizen’s complaint, prior research had suggested that ketamine could cause more complications and severe adverse events, compared with other sedatives.
The trials were conducted between 2014 and 2018, and in its letter, Public Citizen alleged that the investigators and the IRB had allowed these trials to proceed without obtaining informed consent from patients. The goal was to evaluate how well ketamine worked, compared with other drugs in calming agitated individuals: “The patients were given either ketamine or haloperidol for agitation by paramedics who responded to medical emergencies, and the goal was to see which drug worked faster,” said Dr. Carome. “Patients were only notified afterwards that they had received a sedative. Informed consent had been waived by IRB.”
In the first clinical trial conducted by HCMC, published in 2016, the researchers had hypothesized that 5 mg/kg of intramuscular ketamine would be superior to 10 mg of intramuscular haloperidol for severe prehospital agitation. Time to adequate sedation was the primary outcome measure. The study included 146 people; 64 received ketamine and 82 received haloperidol. They found that ketamine worked far more quickly than haloperidol (5 minutes vs. 17 minutes) but that the risk for complications was much higher. Complications occurred in 49% of patients receiving ketamine, compared with 5%.
“There was a 10-fold risk of adverse events,” said Dr. Carome. “And 39% of patients given ketamine had respiratory problems requiring intubation, compared to 4% who received haloperidol.”
A second study was launched in 2017, wherein ketamine was compared with midazolam in agitated patients. During the first 6-month period of the study, individuals would receive a ketamine-based protocol for prehospital agitation, and during the second 6 months, that would switch to midazolam. However, the study was halted in June 2018 after the local newspaper, the Star Tribune, reported that the city police had encouraged medical personnel to sedate agitated patients. This included individuals who had already been physically restrained.
The report stated that “in many cases, the individual being detained or arrested was not only handcuffed but strapped down on a stretcher in an ambulance before receiving ketamine,” and that it raised a “concerning question” over why these people were given the drug before they were transported to the hospital, “given the immediate effects on breathing and heart function that the drug induces.”
Along with halting the trial, HCMC asked for a review of cases involving its paramedics; an independent investigation led by former U.S. Deputy Attorney General Sally Yates was initiated to assess whether the Minneapolis police had crossed a line and urged paramedics to use ketamine.
“The decision to use ketamine was based on the study’s timeline and not on clinical judgment,” said Dr. Carome.
The FDA acknowledged receipt of the complaint and inspected the IRB records and the clinical trial data. Preliminary reports received by Public Citizen confirmed their allegations. “There were not appropriate protections for vulnerable subjects,” he said. “In 2019, the FDA did further investigations, and those reports had similar findings.”
FDA letters
The FDA had sent warning letters to Dr. Cole and Dr. Klein, citing them for ignoring federal safety laws in experimental research on the public. In their investigations, the FDA cited “objectionable conditions” for the studies led by Dr. Cole and Dr. Klein, according to the letters. Both researchers seemingly ignored FDA regulations and used practices that subjected patients to “significantly increased risk,” and the hospital defended its research with “factually incorrect” statements.
In a letter to Dr. Cole, the FDA noted that he never filed INDs for the trials with the FDA, as required by law, and that he also failed to write appropriate protocols to ensure that children and pregnant women were not enrolled in the research. Individuals under the influence of intoxicants also were not excluded, though the use of ketamine is cautioned in this population.
“Administration of the investigational drugs to these subjects placed them at significantly increased risk of the adverse events associated with the investigational products and decreased the acceptability of those risks,” the FDA said in its letter. “Your failure to exclude, and the lack of any precautions for, subjects under the influence of various intoxicants significantly increased the risks and/or decreased the acceptability of the risks associated with the investigational drugs.”
However, Dr. Cole conducted both studies in the prehospital setting and failed to initiate any specific measures to protect study participants, according to the FDA.
Petition denied
Dr. Carome noted that the researchers had committed repetitive egregious regulatory violations over a 4-year period, which were documented by the FDA in their warning letters to Dr. Cole and Dr. Klein. “We felt that they were so egregious that we need to send a signal to the community that this sort of behavior will not be tolerated,” he said. “The FDA denied our petition, and we think that sends the wrong signal to the research community.”
In their response, the FDA noted that as with judicial enforcement, “the Agency makes decisions regarding whether to pursue administrative enforcement action, including disqualification proceedings, on a case-by-case basis, considering all relevant facts and circumstances.” They added that at this time, they would not be taking further action against Dr. Cole and Dr. Klein.
“However, we intend to continue to consider all the options available to the Agency as we determine whether to pursue additional compliance actions related to this matter,” the FDA concluded.
The FDA declined to comment further on their decision.
Dr. Cole also declined to comment, but Hennepin Healthcare told this news organization that the “decision by the FDA to deny the petition validates the changes we made to strengthen and improve the clinical research program across the institution since the closing of the studies in 2018. We look forward to continuing to work with the FDA to ensure full compliance with the standards in place to protect research subjects.”
A version of this article first appeared on Medscape.com.
Increased social services spending ups cancer survival of Blacks
Five-year overall survival increased among non-Hispanic Black patients by 2.02% in conjunction with a 10% increase in spending. In addition, there was a decrease in racial disparities in survival between non-Hispanic Black patients and White patients for many types of cancers.
However, public welfare spending had no real impact on the overall 5-year survival for the entire cohort (0.25 % per 10% increase in spending; P = .78) or for non-Hispanic White patients (0.52% per 10% increase in spending, P = .58).
“We know from prior research that outcomes are worse for minorities,” said lead author Justin Michael Barnes, MD, from the department of radiation oncology at Washington University in St. Louis, Mo. “It’s thought that some of the differences are related to impaired access to health care for minorities, which is related to social determinants of health. This includes socioeconomic factors, educational attainment, place of residence, as well as environmental stressors.
“Our data show that greater state welfare expenditures were associated with greater 5-year survival among Black patients and decreased Black–White disparities,” said Dr. Barnes. “I think these data are thought provoking, but they certainly aren’t the end. I see these data as a proof-of-concept project.”
Dr. Barnes reported the findings at a press conference held in advance of the annual meeting of the American Society of Clinical Oncology, during which the study will be presented (Abstract 6509).
Improved 5-year survival in Black patients
For the study, Dr. Barnes and colleagues evaluated the association of 5-year overall survival and public welfare spending in 2,925,550 individuals aged 18 years and older who were diagnosed with cancer during the period 2007-2016. The cohort was drawn from the Surveillance, Epidemiology, and End Results Program. In addition, annual state spending data were obtained from the U.S. Census Bureau. The team examined survival outcomes by race and ethnicity as well as by cancer site. The investigators accounted for factors such as age, sex, metropolitan residence, state, county-level income and education, insurance status, cancer site, stage at diagnosis, and year of diagnosis.
Much of public welfare spending was related to Medicaid but also included programs that provide subsidy assistance for individuals, such as Supplemental Security Income.
As compared with White patients, the 5-year overall survival rate was 10.8% lower among non-Hispanic Black patients. But there was a 4.46% (P for interaction <.001) narrowing of the 5-year overall survival disparity in non-Hispanic Black patients in comparison with White patients per 10% increase in spending, or a 42% closure of the 10.8% disparity.
Regarding specific cancer types, increased public welfare spending was associated with a narrowing of the 5-year overall survival disparity between Black patients and non-Hispanic White patients for the following cancers: breast (a 6.15% survival increase for Black patients led to a 39% closing of the disparity), cervix (a 11.9% survival increase led to a 46% closing of the disparity), colorectum (a 4.42% survival increase led to a 48% closing of the disparity), head and neck (a 9.41% survival increase led to a 38% closing of the disparity), liver (a 7.02% survival increase led to a 49% closing of the disparity), ovary (an 8.95% survival increase led to a 41% closing of the disparity), bladder (an 8.18% survival increase led to a 44% closing of the disparity), and uterus (a 14.1% survival increase led to a 40% closing of the disparity).
“Some type of public welfare seems to be helping improve oncologic outcomes for some of our most socioeconomically at-risk patients, but we don’t know the specifics,” Dr. Barnes concluded. “Additional work is needed to identify the most influential public health expenditures. If we can do this, we can more rigorously evaluate state-level policies and their association with cancer outcomes.”
Public welfare improves outcomes
Weighing in on the data, Sarah P. Cate, MD, director, Special Surveillance and Breast Program, Mount Sinai Health System, New York, noted that racial disparities have been identified in many areas of health care and with respect to many diseases. “In the world of oncology, time to diagnosis and treatment significantly impacts overall survival,” she told this news organization. “Many studies are currently underway to investigate why certain ethnic groups have worse cancer outcomes.”
This study is important, she noted, in that it “highlights a discrete source of correcting these disparities in a large group of patients. Obviously there are multiple barriers to care, but increased public welfare spending in oncology should decrease some of these disparities.”
Julie R. Gralow, MD, ASCO’s chief medical officer and executive vice president, commented that it is known that state public welfare spending can mitigate structural racism and at least partially address social determinants of health, such as financial stability, education, place of residence, and insurance status. “This research found that states that increased their public health spending improved overall survival in Black patients with a variety of solid tumors and also resulted in a decrease in racial disparities in survival,” she said. “This important data provides clear support for the benefits of investment in public welfare spending at the state level, including Medicaid expansion.”
The study did not receive funding. Dr. Barnes and Dr. Cate have disclosed no relevant financial relationships. Dr. Gralow has relationships with Genentech, AstraZeneca Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
Five-year overall survival increased among non-Hispanic Black patients by 2.02% in conjunction with a 10% increase in spending. In addition, there was a decrease in racial disparities in survival between non-Hispanic Black patients and White patients for many types of cancers.
However, public welfare spending had no real impact on the overall 5-year survival for the entire cohort (0.25 % per 10% increase in spending; P = .78) or for non-Hispanic White patients (0.52% per 10% increase in spending, P = .58).
“We know from prior research that outcomes are worse for minorities,” said lead author Justin Michael Barnes, MD, from the department of radiation oncology at Washington University in St. Louis, Mo. “It’s thought that some of the differences are related to impaired access to health care for minorities, which is related to social determinants of health. This includes socioeconomic factors, educational attainment, place of residence, as well as environmental stressors.
“Our data show that greater state welfare expenditures were associated with greater 5-year survival among Black patients and decreased Black–White disparities,” said Dr. Barnes. “I think these data are thought provoking, but they certainly aren’t the end. I see these data as a proof-of-concept project.”
Dr. Barnes reported the findings at a press conference held in advance of the annual meeting of the American Society of Clinical Oncology, during which the study will be presented (Abstract 6509).
Improved 5-year survival in Black patients
For the study, Dr. Barnes and colleagues evaluated the association of 5-year overall survival and public welfare spending in 2,925,550 individuals aged 18 years and older who were diagnosed with cancer during the period 2007-2016. The cohort was drawn from the Surveillance, Epidemiology, and End Results Program. In addition, annual state spending data were obtained from the U.S. Census Bureau. The team examined survival outcomes by race and ethnicity as well as by cancer site. The investigators accounted for factors such as age, sex, metropolitan residence, state, county-level income and education, insurance status, cancer site, stage at diagnosis, and year of diagnosis.
Much of public welfare spending was related to Medicaid but also included programs that provide subsidy assistance for individuals, such as Supplemental Security Income.
As compared with White patients, the 5-year overall survival rate was 10.8% lower among non-Hispanic Black patients. But there was a 4.46% (P for interaction <.001) narrowing of the 5-year overall survival disparity in non-Hispanic Black patients in comparison with White patients per 10% increase in spending, or a 42% closure of the 10.8% disparity.
Regarding specific cancer types, increased public welfare spending was associated with a narrowing of the 5-year overall survival disparity between Black patients and non-Hispanic White patients for the following cancers: breast (a 6.15% survival increase for Black patients led to a 39% closing of the disparity), cervix (a 11.9% survival increase led to a 46% closing of the disparity), colorectum (a 4.42% survival increase led to a 48% closing of the disparity), head and neck (a 9.41% survival increase led to a 38% closing of the disparity), liver (a 7.02% survival increase led to a 49% closing of the disparity), ovary (an 8.95% survival increase led to a 41% closing of the disparity), bladder (an 8.18% survival increase led to a 44% closing of the disparity), and uterus (a 14.1% survival increase led to a 40% closing of the disparity).
“Some type of public welfare seems to be helping improve oncologic outcomes for some of our most socioeconomically at-risk patients, but we don’t know the specifics,” Dr. Barnes concluded. “Additional work is needed to identify the most influential public health expenditures. If we can do this, we can more rigorously evaluate state-level policies and their association with cancer outcomes.”
Public welfare improves outcomes
Weighing in on the data, Sarah P. Cate, MD, director, Special Surveillance and Breast Program, Mount Sinai Health System, New York, noted that racial disparities have been identified in many areas of health care and with respect to many diseases. “In the world of oncology, time to diagnosis and treatment significantly impacts overall survival,” she told this news organization. “Many studies are currently underway to investigate why certain ethnic groups have worse cancer outcomes.”
This study is important, she noted, in that it “highlights a discrete source of correcting these disparities in a large group of patients. Obviously there are multiple barriers to care, but increased public welfare spending in oncology should decrease some of these disparities.”
Julie R. Gralow, MD, ASCO’s chief medical officer and executive vice president, commented that it is known that state public welfare spending can mitigate structural racism and at least partially address social determinants of health, such as financial stability, education, place of residence, and insurance status. “This research found that states that increased their public health spending improved overall survival in Black patients with a variety of solid tumors and also resulted in a decrease in racial disparities in survival,” she said. “This important data provides clear support for the benefits of investment in public welfare spending at the state level, including Medicaid expansion.”
The study did not receive funding. Dr. Barnes and Dr. Cate have disclosed no relevant financial relationships. Dr. Gralow has relationships with Genentech, AstraZeneca Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
Five-year overall survival increased among non-Hispanic Black patients by 2.02% in conjunction with a 10% increase in spending. In addition, there was a decrease in racial disparities in survival between non-Hispanic Black patients and White patients for many types of cancers.
However, public welfare spending had no real impact on the overall 5-year survival for the entire cohort (0.25 % per 10% increase in spending; P = .78) or for non-Hispanic White patients (0.52% per 10% increase in spending, P = .58).
“We know from prior research that outcomes are worse for minorities,” said lead author Justin Michael Barnes, MD, from the department of radiation oncology at Washington University in St. Louis, Mo. “It’s thought that some of the differences are related to impaired access to health care for minorities, which is related to social determinants of health. This includes socioeconomic factors, educational attainment, place of residence, as well as environmental stressors.
“Our data show that greater state welfare expenditures were associated with greater 5-year survival among Black patients and decreased Black–White disparities,” said Dr. Barnes. “I think these data are thought provoking, but they certainly aren’t the end. I see these data as a proof-of-concept project.”
Dr. Barnes reported the findings at a press conference held in advance of the annual meeting of the American Society of Clinical Oncology, during which the study will be presented (Abstract 6509).
Improved 5-year survival in Black patients
For the study, Dr. Barnes and colleagues evaluated the association of 5-year overall survival and public welfare spending in 2,925,550 individuals aged 18 years and older who were diagnosed with cancer during the period 2007-2016. The cohort was drawn from the Surveillance, Epidemiology, and End Results Program. In addition, annual state spending data were obtained from the U.S. Census Bureau. The team examined survival outcomes by race and ethnicity as well as by cancer site. The investigators accounted for factors such as age, sex, metropolitan residence, state, county-level income and education, insurance status, cancer site, stage at diagnosis, and year of diagnosis.
Much of public welfare spending was related to Medicaid but also included programs that provide subsidy assistance for individuals, such as Supplemental Security Income.
As compared with White patients, the 5-year overall survival rate was 10.8% lower among non-Hispanic Black patients. But there was a 4.46% (P for interaction <.001) narrowing of the 5-year overall survival disparity in non-Hispanic Black patients in comparison with White patients per 10% increase in spending, or a 42% closure of the 10.8% disparity.
Regarding specific cancer types, increased public welfare spending was associated with a narrowing of the 5-year overall survival disparity between Black patients and non-Hispanic White patients for the following cancers: breast (a 6.15% survival increase for Black patients led to a 39% closing of the disparity), cervix (a 11.9% survival increase led to a 46% closing of the disparity), colorectum (a 4.42% survival increase led to a 48% closing of the disparity), head and neck (a 9.41% survival increase led to a 38% closing of the disparity), liver (a 7.02% survival increase led to a 49% closing of the disparity), ovary (an 8.95% survival increase led to a 41% closing of the disparity), bladder (an 8.18% survival increase led to a 44% closing of the disparity), and uterus (a 14.1% survival increase led to a 40% closing of the disparity).
“Some type of public welfare seems to be helping improve oncologic outcomes for some of our most socioeconomically at-risk patients, but we don’t know the specifics,” Dr. Barnes concluded. “Additional work is needed to identify the most influential public health expenditures. If we can do this, we can more rigorously evaluate state-level policies and their association with cancer outcomes.”
Public welfare improves outcomes
Weighing in on the data, Sarah P. Cate, MD, director, Special Surveillance and Breast Program, Mount Sinai Health System, New York, noted that racial disparities have been identified in many areas of health care and with respect to many diseases. “In the world of oncology, time to diagnosis and treatment significantly impacts overall survival,” she told this news organization. “Many studies are currently underway to investigate why certain ethnic groups have worse cancer outcomes.”
This study is important, she noted, in that it “highlights a discrete source of correcting these disparities in a large group of patients. Obviously there are multiple barriers to care, but increased public welfare spending in oncology should decrease some of these disparities.”
Julie R. Gralow, MD, ASCO’s chief medical officer and executive vice president, commented that it is known that state public welfare spending can mitigate structural racism and at least partially address social determinants of health, such as financial stability, education, place of residence, and insurance status. “This research found that states that increased their public health spending improved overall survival in Black patients with a variety of solid tumors and also resulted in a decrease in racial disparities in survival,” she said. “This important data provides clear support for the benefits of investment in public welfare spending at the state level, including Medicaid expansion.”
The study did not receive funding. Dr. Barnes and Dr. Cate have disclosed no relevant financial relationships. Dr. Gralow has relationships with Genentech, AstraZeneca Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
FROM ASCO 2022
Are docs getting fed up with hearing about burnout?
There is a feeling of exhaustion, being unable to shake a lingering cold, suffering from frequent headaches and gastrointestinal disturbances, sleeplessness and shortness of breath ...
That was how burnout was described by clinical psychologist Herbert Freudenberger, PhD, who first used the phrase in a paper back in 1974, after observing the emotional depletion and accompanying psychosomatic symptoms among volunteer staff of a free clinic in New York City. He called it “burnout,” a term borrowed from the slang of substance abusers.
It has now been established beyond a shadow of a doubt that burnout is a serious issue facing physicians across specialties, albeit some more intensely than others. But with the constant barrage of stories published on an almost daily basis, along with studies and surveys, it begs the question:
Some have suggested that the focus should be more on tackling burnout and instituting viable solutions rather than rehashing the problem.
There haven’t been studies or surveys on this question, but several experts have offered their opinion.
Jonathan Fisher, MD, a cardiologist and organizational well-being and resiliency leader at Novant Health, Charlotte, N.C., cautioned that he hesitates to speak about what physicians in general believe. “We are a diverse group of nearly 1 million in the United States alone,” he said.
But he noted that there is a specific phenomenon among burned-out health care providers who are “burned out on burnout.”
“Essentially, the underlying thought is ‘talk is cheap and we want action,’” said Dr. Fisher, who is chair and co-founder of the Ending Physician Burnout Global Summit that was held in 2021. “This reaction is often a reflection of disheartened physicians’ sense of hopelessness and cynicism that systemic change to improve working conditions will happen in our lifetime.”
Dr. Fisher explained that “typically, anyone suffering – physicians or nonphysicians – cares more about ending the suffering as soon as possible than learning its causes, but to alleviate suffering at its core – including the emotional suffering of burnout – we must understand the many causes.”
“To address both the organizational and individual drivers of burnout requires a keen awareness of the thoughts, fears, and dreams of physicians, health care executives, and all other stakeholders in health care,” he added.
Burnout, of course, is a very real problem. The 2022 Medscape Physician Burnout & Depression Report found that nearly half of all respondents (47%) said they are burned out, which was higher than the prior year. Perhaps not surprisingly, burnout among emergency physicians took the biggest leap, jumping from 43% in 2021 to 60% this year. More than half of critical care physicians (56%) also reported that they were burned out.
The World Health Organization’s International Classification of Diseases (ICD-11) – the official compendium of diseases – has categorized burnout as a “syndrome” that results from “chronic workplace stress that has not been successfully managed.” It is considered to be an occupational phenomenon and is not classified as a medical condition.
But whether or not physicians are burned out on hearing about burnout remains unclear. “I am not sure if physicians are tired of hearing about ‘burnout,’ but I do think that they want to hear about solutions that go beyond just telling them to take better care of themselves,” said Anne Thorndike, MD, MPH, an internal medicine physician at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, Boston. “There are major systematic factors that contribute to physicians burning out.”
Why talk about negative outcomes?
Jonathan Ripp, MD, MPH, however, is familiar with this sentiment. “‘Why do we keep identifying a problem without solutions’ is certainly a sentiment that is being expressed,” he said. “It’s a negative outcome, so why do we keep talking about negative outcomes?”
Dr. Ripp, who is a professor of medicine, medical education, and geriatrics and palliative medicine; the senior associate dean for well-being and resilience; and chief wellness officer at Icahn School of Medicine at Mount Sinai, New York, is also a well-known expert and researcher in burnout and physician well-being.
He noted that burnout was one of the first “tools” used as a metric to measure well-being, but it is a negative measurement. “It’s been around a long time, so it has a lot of evidence,” said Dr. Ripp. “But that said, there are other ways of measuring well-being without a negative association, and ways of measuring meaning in work – fulfillment and satisfaction, and so on. It should be balanced.”
But for the average physician not familiar with the long legacy of research, they may be frustrated by this situation. “Then they ask, ‘Why are you just showing me more of this instead of doing something about it?’ but we are actually doing something about it,” said Dr. Ripp.
There are many efforts underway, he explained, but it’s a challenging and complex issue. “There are numerous drivers impacting the well-being of any given segment within the health care workforce,” he said. “It will also vary by discipline and location, and there are also a host of individual factors that may have very little to do with the work environment. There are some very well-established efforts for an organizational approach, but it remains to be seen which is the most effective.”
But in broad strokes, he continued, it’s about tackling the system and not about making an individual more resilient. “Individuals that do engage in activities that improve resilience do better, but that’s not what this is about – it’s not going to solve the problem,” said Dr. Ripp. “Those of us like myself, who are working in this space, are trying to promote a culture of well-being – at the system level.”
The question is how to enable the workforce to do their best work in an efficient way so that the balance of their activities are not the meaningless aspects. “And instead, shoot that balance to the meaningful aspects of work,” he added. “There are enormous challenges, but even though we are working on solutions, I can see how the individual may not see that – they may say, ‘Stop telling me to be resilient, stop telling me there’s a problem,’ but we’re working on it.”
Moving medicine forward
James Jerzak, MD, a family physician in Green Bay, Wisc., and physician lead at Bellin Health, noted that “it seems to me that doctors aren’t burned out talking about burnout, but they are burned out hearing that the solution to burnout is simply for them to become more resilient,” he said. “In actuality, the path to dealing with this huge problem is to make meaningful systemic changes in how medicine is practiced.”
He reiterated that medical care has become increasingly complex, with the aging of the population; the increasing incidence of chronic diseases, such as diabetes; the challenges with the increasing cost of care, higher copays, and lack of health insurance for a large portion of the country; and general incivility toward health care workers that was exacerbated by the pandemic.
“This has all led to significantly increased stress levels for medical workers,” he said. “Couple all of that with the increased work involved in meeting the demands of the electronic health record, and it is clear that the current situation is unsustainable.”
In his own health care system, moving medicine forward has meant advancing team-based care, which translates to expanding teams to include adequate support for physicians. This strategy addressed problems in health care delivery, part of which is burnout.
“In many systems practicing advanced team-based care, the ancillary staff – medical assistants, LPNs, and RNs – play an enhanced role in the patient visit and perform functions such as quality care gap closure, medication review and refill pending, pending orders, and helping with documentation,” he said. “Although the current health care workforce shortages has created challenges, there are a lot of innovative approaches being tried [that are] aimed at providing solutions.”
The second key factor is for systems is to develop robust support for their providers with a broad range of team members, such as case managers, clinical pharmacists, diabetic educators, care coordinators, and others. “The day has passed where individual physicians can effectivity manage all of the complexities of care, especially since there are so many nonclinical factors affecting care,” said Dr. Jerzak.
“The recent focus on the social determinants of health and health equity underlies the fact that it truly takes a team of health care professionals working together to provide optimal care for patients,” he said.
Dr. Thorndike, who mentors premedical and medical trainees, has pointed out that burnout begins way before an individual enters the workplace as a doctor. Burnout begins in the earliest stages of medical practice, with the application process to medical school. The admissions process extends over a 12-month period, causing a great deal of “toxic stress.”
One study found that, compared with non-premedical students, premedical students had greater depression severity and emotional exhaustion.
“The current system of medical school admissions ignores the toll that the lengthy and emotionally exhausting process takes on aspiring physicians,” she said. “This is just one example of many in training and health care that requires physicians to set aside their own lives to achieve their goals and to provide the best possible care to others.”
A version of this article first appeared on Medscape.com.
There is a feeling of exhaustion, being unable to shake a lingering cold, suffering from frequent headaches and gastrointestinal disturbances, sleeplessness and shortness of breath ...
That was how burnout was described by clinical psychologist Herbert Freudenberger, PhD, who first used the phrase in a paper back in 1974, after observing the emotional depletion and accompanying psychosomatic symptoms among volunteer staff of a free clinic in New York City. He called it “burnout,” a term borrowed from the slang of substance abusers.
It has now been established beyond a shadow of a doubt that burnout is a serious issue facing physicians across specialties, albeit some more intensely than others. But with the constant barrage of stories published on an almost daily basis, along with studies and surveys, it begs the question:
Some have suggested that the focus should be more on tackling burnout and instituting viable solutions rather than rehashing the problem.
There haven’t been studies or surveys on this question, but several experts have offered their opinion.
Jonathan Fisher, MD, a cardiologist and organizational well-being and resiliency leader at Novant Health, Charlotte, N.C., cautioned that he hesitates to speak about what physicians in general believe. “We are a diverse group of nearly 1 million in the United States alone,” he said.
But he noted that there is a specific phenomenon among burned-out health care providers who are “burned out on burnout.”
“Essentially, the underlying thought is ‘talk is cheap and we want action,’” said Dr. Fisher, who is chair and co-founder of the Ending Physician Burnout Global Summit that was held in 2021. “This reaction is often a reflection of disheartened physicians’ sense of hopelessness and cynicism that systemic change to improve working conditions will happen in our lifetime.”
Dr. Fisher explained that “typically, anyone suffering – physicians or nonphysicians – cares more about ending the suffering as soon as possible than learning its causes, but to alleviate suffering at its core – including the emotional suffering of burnout – we must understand the many causes.”
“To address both the organizational and individual drivers of burnout requires a keen awareness of the thoughts, fears, and dreams of physicians, health care executives, and all other stakeholders in health care,” he added.
Burnout, of course, is a very real problem. The 2022 Medscape Physician Burnout & Depression Report found that nearly half of all respondents (47%) said they are burned out, which was higher than the prior year. Perhaps not surprisingly, burnout among emergency physicians took the biggest leap, jumping from 43% in 2021 to 60% this year. More than half of critical care physicians (56%) also reported that they were burned out.
The World Health Organization’s International Classification of Diseases (ICD-11) – the official compendium of diseases – has categorized burnout as a “syndrome” that results from “chronic workplace stress that has not been successfully managed.” It is considered to be an occupational phenomenon and is not classified as a medical condition.
But whether or not physicians are burned out on hearing about burnout remains unclear. “I am not sure if physicians are tired of hearing about ‘burnout,’ but I do think that they want to hear about solutions that go beyond just telling them to take better care of themselves,” said Anne Thorndike, MD, MPH, an internal medicine physician at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, Boston. “There are major systematic factors that contribute to physicians burning out.”
Why talk about negative outcomes?
Jonathan Ripp, MD, MPH, however, is familiar with this sentiment. “‘Why do we keep identifying a problem without solutions’ is certainly a sentiment that is being expressed,” he said. “It’s a negative outcome, so why do we keep talking about negative outcomes?”
Dr. Ripp, who is a professor of medicine, medical education, and geriatrics and palliative medicine; the senior associate dean for well-being and resilience; and chief wellness officer at Icahn School of Medicine at Mount Sinai, New York, is also a well-known expert and researcher in burnout and physician well-being.
He noted that burnout was one of the first “tools” used as a metric to measure well-being, but it is a negative measurement. “It’s been around a long time, so it has a lot of evidence,” said Dr. Ripp. “But that said, there are other ways of measuring well-being without a negative association, and ways of measuring meaning in work – fulfillment and satisfaction, and so on. It should be balanced.”
But for the average physician not familiar with the long legacy of research, they may be frustrated by this situation. “Then they ask, ‘Why are you just showing me more of this instead of doing something about it?’ but we are actually doing something about it,” said Dr. Ripp.
There are many efforts underway, he explained, but it’s a challenging and complex issue. “There are numerous drivers impacting the well-being of any given segment within the health care workforce,” he said. “It will also vary by discipline and location, and there are also a host of individual factors that may have very little to do with the work environment. There are some very well-established efforts for an organizational approach, but it remains to be seen which is the most effective.”
But in broad strokes, he continued, it’s about tackling the system and not about making an individual more resilient. “Individuals that do engage in activities that improve resilience do better, but that’s not what this is about – it’s not going to solve the problem,” said Dr. Ripp. “Those of us like myself, who are working in this space, are trying to promote a culture of well-being – at the system level.”
The question is how to enable the workforce to do their best work in an efficient way so that the balance of their activities are not the meaningless aspects. “And instead, shoot that balance to the meaningful aspects of work,” he added. “There are enormous challenges, but even though we are working on solutions, I can see how the individual may not see that – they may say, ‘Stop telling me to be resilient, stop telling me there’s a problem,’ but we’re working on it.”
Moving medicine forward
James Jerzak, MD, a family physician in Green Bay, Wisc., and physician lead at Bellin Health, noted that “it seems to me that doctors aren’t burned out talking about burnout, but they are burned out hearing that the solution to burnout is simply for them to become more resilient,” he said. “In actuality, the path to dealing with this huge problem is to make meaningful systemic changes in how medicine is practiced.”
He reiterated that medical care has become increasingly complex, with the aging of the population; the increasing incidence of chronic diseases, such as diabetes; the challenges with the increasing cost of care, higher copays, and lack of health insurance for a large portion of the country; and general incivility toward health care workers that was exacerbated by the pandemic.
“This has all led to significantly increased stress levels for medical workers,” he said. “Couple all of that with the increased work involved in meeting the demands of the electronic health record, and it is clear that the current situation is unsustainable.”
In his own health care system, moving medicine forward has meant advancing team-based care, which translates to expanding teams to include adequate support for physicians. This strategy addressed problems in health care delivery, part of which is burnout.
“In many systems practicing advanced team-based care, the ancillary staff – medical assistants, LPNs, and RNs – play an enhanced role in the patient visit and perform functions such as quality care gap closure, medication review and refill pending, pending orders, and helping with documentation,” he said. “Although the current health care workforce shortages has created challenges, there are a lot of innovative approaches being tried [that are] aimed at providing solutions.”
The second key factor is for systems is to develop robust support for their providers with a broad range of team members, such as case managers, clinical pharmacists, diabetic educators, care coordinators, and others. “The day has passed where individual physicians can effectivity manage all of the complexities of care, especially since there are so many nonclinical factors affecting care,” said Dr. Jerzak.
“The recent focus on the social determinants of health and health equity underlies the fact that it truly takes a team of health care professionals working together to provide optimal care for patients,” he said.
Dr. Thorndike, who mentors premedical and medical trainees, has pointed out that burnout begins way before an individual enters the workplace as a doctor. Burnout begins in the earliest stages of medical practice, with the application process to medical school. The admissions process extends over a 12-month period, causing a great deal of “toxic stress.”
One study found that, compared with non-premedical students, premedical students had greater depression severity and emotional exhaustion.
“The current system of medical school admissions ignores the toll that the lengthy and emotionally exhausting process takes on aspiring physicians,” she said. “This is just one example of many in training and health care that requires physicians to set aside their own lives to achieve their goals and to provide the best possible care to others.”
A version of this article first appeared on Medscape.com.
There is a feeling of exhaustion, being unable to shake a lingering cold, suffering from frequent headaches and gastrointestinal disturbances, sleeplessness and shortness of breath ...
That was how burnout was described by clinical psychologist Herbert Freudenberger, PhD, who first used the phrase in a paper back in 1974, after observing the emotional depletion and accompanying psychosomatic symptoms among volunteer staff of a free clinic in New York City. He called it “burnout,” a term borrowed from the slang of substance abusers.
It has now been established beyond a shadow of a doubt that burnout is a serious issue facing physicians across specialties, albeit some more intensely than others. But with the constant barrage of stories published on an almost daily basis, along with studies and surveys, it begs the question:
Some have suggested that the focus should be more on tackling burnout and instituting viable solutions rather than rehashing the problem.
There haven’t been studies or surveys on this question, but several experts have offered their opinion.
Jonathan Fisher, MD, a cardiologist and organizational well-being and resiliency leader at Novant Health, Charlotte, N.C., cautioned that he hesitates to speak about what physicians in general believe. “We are a diverse group of nearly 1 million in the United States alone,” he said.
But he noted that there is a specific phenomenon among burned-out health care providers who are “burned out on burnout.”
“Essentially, the underlying thought is ‘talk is cheap and we want action,’” said Dr. Fisher, who is chair and co-founder of the Ending Physician Burnout Global Summit that was held in 2021. “This reaction is often a reflection of disheartened physicians’ sense of hopelessness and cynicism that systemic change to improve working conditions will happen in our lifetime.”
Dr. Fisher explained that “typically, anyone suffering – physicians or nonphysicians – cares more about ending the suffering as soon as possible than learning its causes, but to alleviate suffering at its core – including the emotional suffering of burnout – we must understand the many causes.”
“To address both the organizational and individual drivers of burnout requires a keen awareness of the thoughts, fears, and dreams of physicians, health care executives, and all other stakeholders in health care,” he added.
Burnout, of course, is a very real problem. The 2022 Medscape Physician Burnout & Depression Report found that nearly half of all respondents (47%) said they are burned out, which was higher than the prior year. Perhaps not surprisingly, burnout among emergency physicians took the biggest leap, jumping from 43% in 2021 to 60% this year. More than half of critical care physicians (56%) also reported that they were burned out.
The World Health Organization’s International Classification of Diseases (ICD-11) – the official compendium of diseases – has categorized burnout as a “syndrome” that results from “chronic workplace stress that has not been successfully managed.” It is considered to be an occupational phenomenon and is not classified as a medical condition.
But whether or not physicians are burned out on hearing about burnout remains unclear. “I am not sure if physicians are tired of hearing about ‘burnout,’ but I do think that they want to hear about solutions that go beyond just telling them to take better care of themselves,” said Anne Thorndike, MD, MPH, an internal medicine physician at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, Boston. “There are major systematic factors that contribute to physicians burning out.”
Why talk about negative outcomes?
Jonathan Ripp, MD, MPH, however, is familiar with this sentiment. “‘Why do we keep identifying a problem without solutions’ is certainly a sentiment that is being expressed,” he said. “It’s a negative outcome, so why do we keep talking about negative outcomes?”
Dr. Ripp, who is a professor of medicine, medical education, and geriatrics and palliative medicine; the senior associate dean for well-being and resilience; and chief wellness officer at Icahn School of Medicine at Mount Sinai, New York, is also a well-known expert and researcher in burnout and physician well-being.
He noted that burnout was one of the first “tools” used as a metric to measure well-being, but it is a negative measurement. “It’s been around a long time, so it has a lot of evidence,” said Dr. Ripp. “But that said, there are other ways of measuring well-being without a negative association, and ways of measuring meaning in work – fulfillment and satisfaction, and so on. It should be balanced.”
But for the average physician not familiar with the long legacy of research, they may be frustrated by this situation. “Then they ask, ‘Why are you just showing me more of this instead of doing something about it?’ but we are actually doing something about it,” said Dr. Ripp.
There are many efforts underway, he explained, but it’s a challenging and complex issue. “There are numerous drivers impacting the well-being of any given segment within the health care workforce,” he said. “It will also vary by discipline and location, and there are also a host of individual factors that may have very little to do with the work environment. There are some very well-established efforts for an organizational approach, but it remains to be seen which is the most effective.”
But in broad strokes, he continued, it’s about tackling the system and not about making an individual more resilient. “Individuals that do engage in activities that improve resilience do better, but that’s not what this is about – it’s not going to solve the problem,” said Dr. Ripp. “Those of us like myself, who are working in this space, are trying to promote a culture of well-being – at the system level.”
The question is how to enable the workforce to do their best work in an efficient way so that the balance of their activities are not the meaningless aspects. “And instead, shoot that balance to the meaningful aspects of work,” he added. “There are enormous challenges, but even though we are working on solutions, I can see how the individual may not see that – they may say, ‘Stop telling me to be resilient, stop telling me there’s a problem,’ but we’re working on it.”
Moving medicine forward
James Jerzak, MD, a family physician in Green Bay, Wisc., and physician lead at Bellin Health, noted that “it seems to me that doctors aren’t burned out talking about burnout, but they are burned out hearing that the solution to burnout is simply for them to become more resilient,” he said. “In actuality, the path to dealing with this huge problem is to make meaningful systemic changes in how medicine is practiced.”
He reiterated that medical care has become increasingly complex, with the aging of the population; the increasing incidence of chronic diseases, such as diabetes; the challenges with the increasing cost of care, higher copays, and lack of health insurance for a large portion of the country; and general incivility toward health care workers that was exacerbated by the pandemic.
“This has all led to significantly increased stress levels for medical workers,” he said. “Couple all of that with the increased work involved in meeting the demands of the electronic health record, and it is clear that the current situation is unsustainable.”
In his own health care system, moving medicine forward has meant advancing team-based care, which translates to expanding teams to include adequate support for physicians. This strategy addressed problems in health care delivery, part of which is burnout.
“In many systems practicing advanced team-based care, the ancillary staff – medical assistants, LPNs, and RNs – play an enhanced role in the patient visit and perform functions such as quality care gap closure, medication review and refill pending, pending orders, and helping with documentation,” he said. “Although the current health care workforce shortages has created challenges, there are a lot of innovative approaches being tried [that are] aimed at providing solutions.”
The second key factor is for systems is to develop robust support for their providers with a broad range of team members, such as case managers, clinical pharmacists, diabetic educators, care coordinators, and others. “The day has passed where individual physicians can effectivity manage all of the complexities of care, especially since there are so many nonclinical factors affecting care,” said Dr. Jerzak.
“The recent focus on the social determinants of health and health equity underlies the fact that it truly takes a team of health care professionals working together to provide optimal care for patients,” he said.
Dr. Thorndike, who mentors premedical and medical trainees, has pointed out that burnout begins way before an individual enters the workplace as a doctor. Burnout begins in the earliest stages of medical practice, with the application process to medical school. The admissions process extends over a 12-month period, causing a great deal of “toxic stress.”
One study found that, compared with non-premedical students, premedical students had greater depression severity and emotional exhaustion.
“The current system of medical school admissions ignores the toll that the lengthy and emotionally exhausting process takes on aspiring physicians,” she said. “This is just one example of many in training and health care that requires physicians to set aside their own lives to achieve their goals and to provide the best possible care to others.”
A version of this article first appeared on Medscape.com.
Young leukemia survivors still dying early, study shows
Although adolescents and young adults (AYAs) who survive leukemia are living much longer than ever before, their life spans are still shorter than those of the general population, a new study concludes.
The study found that the 10-year survival of AYA leukemia survivors was approximately 10% lower than that of the age-adjusted U.S. general population at large.
These differences persisted for up to 30 years of follow-up.
“We need to think about the long-term life span and the quality of life for our patients. Cure is not enough for our AYA cancer survivors,” said senior author Michael Roth, MD, associate professor of pediatric patient care and director of the Childhood Cancer Survivorship Clinic at the University of Texas MD Anderson Cancer Center, Houston.
“Once these patients reach the survivorship stage of their journey, they may encounter additional side effects as a result of intensive treatment, lack of access to quality health care, and other issues that may negatively impact their health and overall survival,” he said in a statement.
The study was published in Cancer Epidemiology, Biomarkers and Prevention.
Demographics play role in survival
AYAs were defined as those persons aged 15-39 years. For their study, Dr. Roth and colleagues used the Surveillance, Epidemiology, and End Results (SEER) registry to identify 1,938 AYA survivors of acute lymphoblastic leukemia (ALL) and 2,350 AYA survivors of acute myeloid leukemia (AML) who were diagnosed from 1980 to 2009. They were followed for a median of 12 years.
The median age at diagnosis was 23 years for ALL and 28 years for AML.
Among ALL survivors, 6% were Black, 7% were Asian or Pacific Islander, 29% were Hispanic, and 58% were White. Among AML survivors, 9% were Black, 10% were Asian or Pacific Islander, 22% were Hispanic, and 59% were White. Ten-year survival for ALL and AML survivors was 87% and 89%, respectively. For the general population, it was 99%.
For ALL survivors, the 10-year survival was 83% for those diagnosed in the 1980s; it was 88% for those diagnosed in the 1990s and in the 2000s. The pattern was similar for AML survivors: 82%, 90%, and 90%.
The most common cause of death during early survivorship was acute leukemia. Deaths plateaued approximately 10 years after the initial diagnosis.
“Some of these patients aren’t being fully cured of their initial cancer, so between 5 and 10 years post initial diagnosis, most of the deaths are due to disease progression or relapse, whereas after that, most of the deaths result from late side effects from treatment, including cardiovascular disease and secondary cancers,” Dr. Roth said. Mortality from other causes continued to rise during the survivorship period. Subsequent malignancies and cardiac disease were the most common causes of death for both ALL and AML survivors.
A recent study found that AYA cancer survivors face nearly a twofold higher risk of dying from a new primary cancer, compared with peers in the general population.
When looking at key demographics, the authors found that older age at diagnosis was significantly associated with differential long-term survival (P < .0001 for both ALL and AML). Each additional year older at diagnosis was associated with a 6% and 5% decrease in long-term survival for both types of leukemia.
The decade in which the diagnosis was made had a significant difference in long-term survival both for patients with ALL and those with AML. Long-term survival times for those diagnosed in the 1990s were more than twice those of patients diagnosed in the 1980s for ALL (unadjusted P = .008) and AML (unadjusted P = .0002). Survival times were also more than twice those of patients diagnosed in the 2000s versus the 1980s for ALL (unadjusted P = .009) and AML (unadjusted P = .0003).
No significant long-term survival differences were observed for those diagnosed in the 2000s, compared with the 1990s, for either leukemia.
“The data from the national registry used for this study gave us insights into some possible challenges AML and ALL patients may encounter throughout survivorship, but we need to more thoroughly survey their journey,” Dr. Roth said. “An examination of their socioeconomic status, comorbidities, access to quality health care, and other risk factors that may impact their survivorship is warranted.”
The research was supported by the National Cancer Institute at the National Institutes of Health, the Archer Charitable Foundation, and LyondellBasell. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Although adolescents and young adults (AYAs) who survive leukemia are living much longer than ever before, their life spans are still shorter than those of the general population, a new study concludes.
The study found that the 10-year survival of AYA leukemia survivors was approximately 10% lower than that of the age-adjusted U.S. general population at large.
These differences persisted for up to 30 years of follow-up.
“We need to think about the long-term life span and the quality of life for our patients. Cure is not enough for our AYA cancer survivors,” said senior author Michael Roth, MD, associate professor of pediatric patient care and director of the Childhood Cancer Survivorship Clinic at the University of Texas MD Anderson Cancer Center, Houston.
“Once these patients reach the survivorship stage of their journey, they may encounter additional side effects as a result of intensive treatment, lack of access to quality health care, and other issues that may negatively impact their health and overall survival,” he said in a statement.
The study was published in Cancer Epidemiology, Biomarkers and Prevention.
Demographics play role in survival
AYAs were defined as those persons aged 15-39 years. For their study, Dr. Roth and colleagues used the Surveillance, Epidemiology, and End Results (SEER) registry to identify 1,938 AYA survivors of acute lymphoblastic leukemia (ALL) and 2,350 AYA survivors of acute myeloid leukemia (AML) who were diagnosed from 1980 to 2009. They were followed for a median of 12 years.
The median age at diagnosis was 23 years for ALL and 28 years for AML.
Among ALL survivors, 6% were Black, 7% were Asian or Pacific Islander, 29% were Hispanic, and 58% were White. Among AML survivors, 9% were Black, 10% were Asian or Pacific Islander, 22% were Hispanic, and 59% were White. Ten-year survival for ALL and AML survivors was 87% and 89%, respectively. For the general population, it was 99%.
For ALL survivors, the 10-year survival was 83% for those diagnosed in the 1980s; it was 88% for those diagnosed in the 1990s and in the 2000s. The pattern was similar for AML survivors: 82%, 90%, and 90%.
The most common cause of death during early survivorship was acute leukemia. Deaths plateaued approximately 10 years after the initial diagnosis.
“Some of these patients aren’t being fully cured of their initial cancer, so between 5 and 10 years post initial diagnosis, most of the deaths are due to disease progression or relapse, whereas after that, most of the deaths result from late side effects from treatment, including cardiovascular disease and secondary cancers,” Dr. Roth said. Mortality from other causes continued to rise during the survivorship period. Subsequent malignancies and cardiac disease were the most common causes of death for both ALL and AML survivors.
A recent study found that AYA cancer survivors face nearly a twofold higher risk of dying from a new primary cancer, compared with peers in the general population.
When looking at key demographics, the authors found that older age at diagnosis was significantly associated with differential long-term survival (P < .0001 for both ALL and AML). Each additional year older at diagnosis was associated with a 6% and 5% decrease in long-term survival for both types of leukemia.
The decade in which the diagnosis was made had a significant difference in long-term survival both for patients with ALL and those with AML. Long-term survival times for those diagnosed in the 1990s were more than twice those of patients diagnosed in the 1980s for ALL (unadjusted P = .008) and AML (unadjusted P = .0002). Survival times were also more than twice those of patients diagnosed in the 2000s versus the 1980s for ALL (unadjusted P = .009) and AML (unadjusted P = .0003).
No significant long-term survival differences were observed for those diagnosed in the 2000s, compared with the 1990s, for either leukemia.
“The data from the national registry used for this study gave us insights into some possible challenges AML and ALL patients may encounter throughout survivorship, but we need to more thoroughly survey their journey,” Dr. Roth said. “An examination of their socioeconomic status, comorbidities, access to quality health care, and other risk factors that may impact their survivorship is warranted.”
The research was supported by the National Cancer Institute at the National Institutes of Health, the Archer Charitable Foundation, and LyondellBasell. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Although adolescents and young adults (AYAs) who survive leukemia are living much longer than ever before, their life spans are still shorter than those of the general population, a new study concludes.
The study found that the 10-year survival of AYA leukemia survivors was approximately 10% lower than that of the age-adjusted U.S. general population at large.
These differences persisted for up to 30 years of follow-up.
“We need to think about the long-term life span and the quality of life for our patients. Cure is not enough for our AYA cancer survivors,” said senior author Michael Roth, MD, associate professor of pediatric patient care and director of the Childhood Cancer Survivorship Clinic at the University of Texas MD Anderson Cancer Center, Houston.
“Once these patients reach the survivorship stage of their journey, they may encounter additional side effects as a result of intensive treatment, lack of access to quality health care, and other issues that may negatively impact their health and overall survival,” he said in a statement.
The study was published in Cancer Epidemiology, Biomarkers and Prevention.
Demographics play role in survival
AYAs were defined as those persons aged 15-39 years. For their study, Dr. Roth and colleagues used the Surveillance, Epidemiology, and End Results (SEER) registry to identify 1,938 AYA survivors of acute lymphoblastic leukemia (ALL) and 2,350 AYA survivors of acute myeloid leukemia (AML) who were diagnosed from 1980 to 2009. They were followed for a median of 12 years.
The median age at diagnosis was 23 years for ALL and 28 years for AML.
Among ALL survivors, 6% were Black, 7% were Asian or Pacific Islander, 29% were Hispanic, and 58% were White. Among AML survivors, 9% were Black, 10% were Asian or Pacific Islander, 22% were Hispanic, and 59% were White. Ten-year survival for ALL and AML survivors was 87% and 89%, respectively. For the general population, it was 99%.
For ALL survivors, the 10-year survival was 83% for those diagnosed in the 1980s; it was 88% for those diagnosed in the 1990s and in the 2000s. The pattern was similar for AML survivors: 82%, 90%, and 90%.
The most common cause of death during early survivorship was acute leukemia. Deaths plateaued approximately 10 years after the initial diagnosis.
“Some of these patients aren’t being fully cured of their initial cancer, so between 5 and 10 years post initial diagnosis, most of the deaths are due to disease progression or relapse, whereas after that, most of the deaths result from late side effects from treatment, including cardiovascular disease and secondary cancers,” Dr. Roth said. Mortality from other causes continued to rise during the survivorship period. Subsequent malignancies and cardiac disease were the most common causes of death for both ALL and AML survivors.
A recent study found that AYA cancer survivors face nearly a twofold higher risk of dying from a new primary cancer, compared with peers in the general population.
When looking at key demographics, the authors found that older age at diagnosis was significantly associated with differential long-term survival (P < .0001 for both ALL and AML). Each additional year older at diagnosis was associated with a 6% and 5% decrease in long-term survival for both types of leukemia.
The decade in which the diagnosis was made had a significant difference in long-term survival both for patients with ALL and those with AML. Long-term survival times for those diagnosed in the 1990s were more than twice those of patients diagnosed in the 1980s for ALL (unadjusted P = .008) and AML (unadjusted P = .0002). Survival times were also more than twice those of patients diagnosed in the 2000s versus the 1980s for ALL (unadjusted P = .009) and AML (unadjusted P = .0003).
No significant long-term survival differences were observed for those diagnosed in the 2000s, compared with the 1990s, for either leukemia.
“The data from the national registry used for this study gave us insights into some possible challenges AML and ALL patients may encounter throughout survivorship, but we need to more thoroughly survey their journey,” Dr. Roth said. “An examination of their socioeconomic status, comorbidities, access to quality health care, and other risk factors that may impact their survivorship is warranted.”
The research was supported by the National Cancer Institute at the National Institutes of Health, the Archer Charitable Foundation, and LyondellBasell. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CANCER EPIDEMIOLOGY, BIOMARKERS AND PREVENTION
Improved cancer survival in states with ACA Medicaid expansion
compared with patients in states that did not adopt the expansion.
The finding comes from an American Cancer Society study of more than 2 million patients with newly diagnosed cancer, published online in the Journal of the National Cancer Institute.
The analysis also showed that the evidence was strongest for malignancies with poor prognosis such as lung, pancreatic, and liver cancer, and also for colorectal cancer.
Importantly, improvements in survival were larger in non-Hispanic Black patients and individuals residing in rural areas, suggesting there was a narrowing of disparities in cancer survival by race and rurality.
“Our findings provide further evidence of the importance of expanding Medicaid eligibility in all states, particularly considering the economic crisis and health care disruptions caused by the COVID-19 pandemic,” said lead author Xuesong Han, PhD, scientific director of health services research at the American Cancer Society, in a statement. “What’s encouraging is the American Rescue Plan Act of 2021 provides new incentives for Medicaid expansion in states that have yet to increase eligibility.”
The ACA provided states with incentives to expand Medicaid eligibility to all low-income adults under 138% federal poverty level, regardless of parental status.
As of last month, just 12 states have not yet opted for Medicaid expansion, even though the American Rescue Plan Act of 2021 provides new incentives for those remaining jurisdictions. But to date, none of the remaining states have taken advantage of these new incentives.
An interactive map showing the status of Medicare expansion by state is available here. The 12 states that have not adopted Medicare expansion (as of April) are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.
The benefit of Medicaid expansion on cancer outcomes has already been observed in other studies. The first study to show a survival benefit was presented at the 2020 American Society of Clinical Oncology annual meeting. That analysis showed that cancer mortality declined by 29% in states that expanded Medicaid and by 25% in those that did not. The authors also noted that the greatest mortality benefit was observed in Hispanic patients.
Improved survival with expansion
In the current paper, Dr. Han and colleagues used population-based cancer registries from 42 states and compared data on patients aged 18-62 years who were diagnosed with cancer in a period of 2 years before (2010-2012) and after (2014-2016) ACA Medicaid expansion. They were followed through Sept. 30, 2013, and Dec. 31, 2017, respectively.
The analysis involved a total of 2.5 million patients, of whom 1.52 million lived in states that adopted Medicaid expansion and compared with 1 million patients were in states that did not.
Patients with grouped by sex, race and ethnicity, census tract-level poverty, and rurality. The authors note that non-Hispanic Black patients and those from high poverty areas and nonmetropolitan areas were disproportionately represented in nonexpansion states.
During the 2-year follow-up period, a total of 453,487 deaths occurred (257,950 in expansion states and 195,537 in nonexpansion states).
Overall, patients in expansion states generally had better survival versus those in nonexpansion states, the authors comment. However, for most cancer types, overall survival improved after the ACA for both groups of states.
The 2-year overall survival increased from 80.6% before the ACA to 82.2% post ACA in expansion states and from 78.7% to 80% in nonexpansion states.
This extrapolated to net increase of 0.44 percentage points in expansion states after adjusting for sociodemographic factors. By cancer site, the net increase was greater for colorectal cancer, lung cancer, non-Hodgkin’s lymphoma, pancreatic cancer, and liver cancer.
For Hispanic patients, 2-year survival also increased but was similar in expansion and nonexpansion states, and little net change was associated with Medicaid expansion.
“Our study shows that the increase was largely driven by improvements in survival for cancer types with poor prognosis, suggesting improved access to timely and effective treatments,” said Dr. Han. “It adds to accumulating evidence of the multiple benefits of Medicaid expansion.”
A version of this article first appeared on Medscape.com.
compared with patients in states that did not adopt the expansion.
The finding comes from an American Cancer Society study of more than 2 million patients with newly diagnosed cancer, published online in the Journal of the National Cancer Institute.
The analysis also showed that the evidence was strongest for malignancies with poor prognosis such as lung, pancreatic, and liver cancer, and also for colorectal cancer.
Importantly, improvements in survival were larger in non-Hispanic Black patients and individuals residing in rural areas, suggesting there was a narrowing of disparities in cancer survival by race and rurality.
“Our findings provide further evidence of the importance of expanding Medicaid eligibility in all states, particularly considering the economic crisis and health care disruptions caused by the COVID-19 pandemic,” said lead author Xuesong Han, PhD, scientific director of health services research at the American Cancer Society, in a statement. “What’s encouraging is the American Rescue Plan Act of 2021 provides new incentives for Medicaid expansion in states that have yet to increase eligibility.”
The ACA provided states with incentives to expand Medicaid eligibility to all low-income adults under 138% federal poverty level, regardless of parental status.
As of last month, just 12 states have not yet opted for Medicaid expansion, even though the American Rescue Plan Act of 2021 provides new incentives for those remaining jurisdictions. But to date, none of the remaining states have taken advantage of these new incentives.
An interactive map showing the status of Medicare expansion by state is available here. The 12 states that have not adopted Medicare expansion (as of April) are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.
The benefit of Medicaid expansion on cancer outcomes has already been observed in other studies. The first study to show a survival benefit was presented at the 2020 American Society of Clinical Oncology annual meeting. That analysis showed that cancer mortality declined by 29% in states that expanded Medicaid and by 25% in those that did not. The authors also noted that the greatest mortality benefit was observed in Hispanic patients.
Improved survival with expansion
In the current paper, Dr. Han and colleagues used population-based cancer registries from 42 states and compared data on patients aged 18-62 years who were diagnosed with cancer in a period of 2 years before (2010-2012) and after (2014-2016) ACA Medicaid expansion. They were followed through Sept. 30, 2013, and Dec. 31, 2017, respectively.
The analysis involved a total of 2.5 million patients, of whom 1.52 million lived in states that adopted Medicaid expansion and compared with 1 million patients were in states that did not.
Patients with grouped by sex, race and ethnicity, census tract-level poverty, and rurality. The authors note that non-Hispanic Black patients and those from high poverty areas and nonmetropolitan areas were disproportionately represented in nonexpansion states.
During the 2-year follow-up period, a total of 453,487 deaths occurred (257,950 in expansion states and 195,537 in nonexpansion states).
Overall, patients in expansion states generally had better survival versus those in nonexpansion states, the authors comment. However, for most cancer types, overall survival improved after the ACA for both groups of states.
The 2-year overall survival increased from 80.6% before the ACA to 82.2% post ACA in expansion states and from 78.7% to 80% in nonexpansion states.
This extrapolated to net increase of 0.44 percentage points in expansion states after adjusting for sociodemographic factors. By cancer site, the net increase was greater for colorectal cancer, lung cancer, non-Hodgkin’s lymphoma, pancreatic cancer, and liver cancer.
For Hispanic patients, 2-year survival also increased but was similar in expansion and nonexpansion states, and little net change was associated with Medicaid expansion.
“Our study shows that the increase was largely driven by improvements in survival for cancer types with poor prognosis, suggesting improved access to timely and effective treatments,” said Dr. Han. “It adds to accumulating evidence of the multiple benefits of Medicaid expansion.”
A version of this article first appeared on Medscape.com.
compared with patients in states that did not adopt the expansion.
The finding comes from an American Cancer Society study of more than 2 million patients with newly diagnosed cancer, published online in the Journal of the National Cancer Institute.
The analysis also showed that the evidence was strongest for malignancies with poor prognosis such as lung, pancreatic, and liver cancer, and also for colorectal cancer.
Importantly, improvements in survival were larger in non-Hispanic Black patients and individuals residing in rural areas, suggesting there was a narrowing of disparities in cancer survival by race and rurality.
“Our findings provide further evidence of the importance of expanding Medicaid eligibility in all states, particularly considering the economic crisis and health care disruptions caused by the COVID-19 pandemic,” said lead author Xuesong Han, PhD, scientific director of health services research at the American Cancer Society, in a statement. “What’s encouraging is the American Rescue Plan Act of 2021 provides new incentives for Medicaid expansion in states that have yet to increase eligibility.”
The ACA provided states with incentives to expand Medicaid eligibility to all low-income adults under 138% federal poverty level, regardless of parental status.
As of last month, just 12 states have not yet opted for Medicaid expansion, even though the American Rescue Plan Act of 2021 provides new incentives for those remaining jurisdictions. But to date, none of the remaining states have taken advantage of these new incentives.
An interactive map showing the status of Medicare expansion by state is available here. The 12 states that have not adopted Medicare expansion (as of April) are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.
The benefit of Medicaid expansion on cancer outcomes has already been observed in other studies. The first study to show a survival benefit was presented at the 2020 American Society of Clinical Oncology annual meeting. That analysis showed that cancer mortality declined by 29% in states that expanded Medicaid and by 25% in those that did not. The authors also noted that the greatest mortality benefit was observed in Hispanic patients.
Improved survival with expansion
In the current paper, Dr. Han and colleagues used population-based cancer registries from 42 states and compared data on patients aged 18-62 years who were diagnosed with cancer in a period of 2 years before (2010-2012) and after (2014-2016) ACA Medicaid expansion. They were followed through Sept. 30, 2013, and Dec. 31, 2017, respectively.
The analysis involved a total of 2.5 million patients, of whom 1.52 million lived in states that adopted Medicaid expansion and compared with 1 million patients were in states that did not.
Patients with grouped by sex, race and ethnicity, census tract-level poverty, and rurality. The authors note that non-Hispanic Black patients and those from high poverty areas and nonmetropolitan areas were disproportionately represented in nonexpansion states.
During the 2-year follow-up period, a total of 453,487 deaths occurred (257,950 in expansion states and 195,537 in nonexpansion states).
Overall, patients in expansion states generally had better survival versus those in nonexpansion states, the authors comment. However, for most cancer types, overall survival improved after the ACA for both groups of states.
The 2-year overall survival increased from 80.6% before the ACA to 82.2% post ACA in expansion states and from 78.7% to 80% in nonexpansion states.
This extrapolated to net increase of 0.44 percentage points in expansion states after adjusting for sociodemographic factors. By cancer site, the net increase was greater for colorectal cancer, lung cancer, non-Hodgkin’s lymphoma, pancreatic cancer, and liver cancer.
For Hispanic patients, 2-year survival also increased but was similar in expansion and nonexpansion states, and little net change was associated with Medicaid expansion.
“Our study shows that the increase was largely driven by improvements in survival for cancer types with poor prognosis, suggesting improved access to timely and effective treatments,” said Dr. Han. “It adds to accumulating evidence of the multiple benefits of Medicaid expansion.”
A version of this article first appeared on Medscape.com.
Jury is in? Survival benefit with lap surgery for rectal cancer
, according to findings from a large meta-analysis.
The estimated 5-year OS rate for patients who underwent laparoscopic surgery was 76.2%, vs. 72.7% for those who had open surgery.
“The survival benefit of laparoscopic surgery is encouraging and supports the routine use of laparoscopic surgery for adult patients with rectal cancer in the era of minimally invasive surgery,” wrote the authors, led by Leping Li, MD, of the department of gastrointestinal surgery, Shandong (China) Provincial Hospital.
The article was published online in JAMA Network Open.
Surgery is an essential component in treating rectal cancer, but the benefits of laparoscopic vs. open surgery are not clear. Over the past 15 years, randomized clinical trials (RCTs) have shown comparable long-term outcomes for laparoscopic and open surgery. However, in most meta-analyses that assessed the evidence more broadly, researchers used an “inappropriate” method for the pooled analysis. Dr. Li and colleagues wanted to perform their own meta-analysis to more definitively understand whether the evidence on long-term outcomes supports or opposes the use of laparoscopic surgery for rectal cancer.
In the current study, the authors conducted an individual participant data meta-analysis using time-to-event data and focused on the long-term survival outcomes after laparoscopic or open surgery for adult patients with rectal cancer.
Ten articles involving 12 RCTs and 3,709 participants were included. In these, 2,097 patients were randomly assigned to undergo laparoscopic surgery, and 1,612 were randomly assigned to undergo open surgery. The studies covered a global population, with participants from Europe, North America, and East Asia.
In a one-stage analysis, the authors found that disease-free survival was slightly better among patients who underwent laparoscopic surgery, but the results were statistically similar (hazard ratio [HR], 0.92; P = .26).
However, when it came to OS, those who had undergone laparoscopic surgery fared significantly better (HR, 0.85; P = .02).
These results held up in the two-stage analysis for both disease-free survival (HR, 0.92; P = .25) and OS (HR, 0.85; P = .02). A sensitivity analyses conducted with large RCTs yielded similar pooled effect sizes for disease-free survival (HR, 0.91; P = .20) and OS (HR, 0.84; P = .03).
The authors highlighted several reasons why laparoscopic surgery may be associated with better survival. First, the faster recovery from the minimally invasive procedure could allow patients to begin adjuvant therapy earlier. In addition, the reduced stress responses and higher levels of immune function among patients undergoing minimally invasive surgery may contribute to a long-term survival advantage.
“These findings address concerns regarding the effectiveness of laparoscopic surgery,” the authors wrote. However, “further studies are necessary to explore the specific mechanisms underlying the positive effect of laparoscopic surgery on OS.”
No outside funding source was noted. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to findings from a large meta-analysis.
The estimated 5-year OS rate for patients who underwent laparoscopic surgery was 76.2%, vs. 72.7% for those who had open surgery.
“The survival benefit of laparoscopic surgery is encouraging and supports the routine use of laparoscopic surgery for adult patients with rectal cancer in the era of minimally invasive surgery,” wrote the authors, led by Leping Li, MD, of the department of gastrointestinal surgery, Shandong (China) Provincial Hospital.
The article was published online in JAMA Network Open.
Surgery is an essential component in treating rectal cancer, but the benefits of laparoscopic vs. open surgery are not clear. Over the past 15 years, randomized clinical trials (RCTs) have shown comparable long-term outcomes for laparoscopic and open surgery. However, in most meta-analyses that assessed the evidence more broadly, researchers used an “inappropriate” method for the pooled analysis. Dr. Li and colleagues wanted to perform their own meta-analysis to more definitively understand whether the evidence on long-term outcomes supports or opposes the use of laparoscopic surgery for rectal cancer.
In the current study, the authors conducted an individual participant data meta-analysis using time-to-event data and focused on the long-term survival outcomes after laparoscopic or open surgery for adult patients with rectal cancer.
Ten articles involving 12 RCTs and 3,709 participants were included. In these, 2,097 patients were randomly assigned to undergo laparoscopic surgery, and 1,612 were randomly assigned to undergo open surgery. The studies covered a global population, with participants from Europe, North America, and East Asia.
In a one-stage analysis, the authors found that disease-free survival was slightly better among patients who underwent laparoscopic surgery, but the results were statistically similar (hazard ratio [HR], 0.92; P = .26).
However, when it came to OS, those who had undergone laparoscopic surgery fared significantly better (HR, 0.85; P = .02).
These results held up in the two-stage analysis for both disease-free survival (HR, 0.92; P = .25) and OS (HR, 0.85; P = .02). A sensitivity analyses conducted with large RCTs yielded similar pooled effect sizes for disease-free survival (HR, 0.91; P = .20) and OS (HR, 0.84; P = .03).
The authors highlighted several reasons why laparoscopic surgery may be associated with better survival. First, the faster recovery from the minimally invasive procedure could allow patients to begin adjuvant therapy earlier. In addition, the reduced stress responses and higher levels of immune function among patients undergoing minimally invasive surgery may contribute to a long-term survival advantage.
“These findings address concerns regarding the effectiveness of laparoscopic surgery,” the authors wrote. However, “further studies are necessary to explore the specific mechanisms underlying the positive effect of laparoscopic surgery on OS.”
No outside funding source was noted. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to findings from a large meta-analysis.
The estimated 5-year OS rate for patients who underwent laparoscopic surgery was 76.2%, vs. 72.7% for those who had open surgery.
“The survival benefit of laparoscopic surgery is encouraging and supports the routine use of laparoscopic surgery for adult patients with rectal cancer in the era of minimally invasive surgery,” wrote the authors, led by Leping Li, MD, of the department of gastrointestinal surgery, Shandong (China) Provincial Hospital.
The article was published online in JAMA Network Open.
Surgery is an essential component in treating rectal cancer, but the benefits of laparoscopic vs. open surgery are not clear. Over the past 15 years, randomized clinical trials (RCTs) have shown comparable long-term outcomes for laparoscopic and open surgery. However, in most meta-analyses that assessed the evidence more broadly, researchers used an “inappropriate” method for the pooled analysis. Dr. Li and colleagues wanted to perform their own meta-analysis to more definitively understand whether the evidence on long-term outcomes supports or opposes the use of laparoscopic surgery for rectal cancer.
In the current study, the authors conducted an individual participant data meta-analysis using time-to-event data and focused on the long-term survival outcomes after laparoscopic or open surgery for adult patients with rectal cancer.
Ten articles involving 12 RCTs and 3,709 participants were included. In these, 2,097 patients were randomly assigned to undergo laparoscopic surgery, and 1,612 were randomly assigned to undergo open surgery. The studies covered a global population, with participants from Europe, North America, and East Asia.
In a one-stage analysis, the authors found that disease-free survival was slightly better among patients who underwent laparoscopic surgery, but the results were statistically similar (hazard ratio [HR], 0.92; P = .26).
However, when it came to OS, those who had undergone laparoscopic surgery fared significantly better (HR, 0.85; P = .02).
These results held up in the two-stage analysis for both disease-free survival (HR, 0.92; P = .25) and OS (HR, 0.85; P = .02). A sensitivity analyses conducted with large RCTs yielded similar pooled effect sizes for disease-free survival (HR, 0.91; P = .20) and OS (HR, 0.84; P = .03).
The authors highlighted several reasons why laparoscopic surgery may be associated with better survival. First, the faster recovery from the minimally invasive procedure could allow patients to begin adjuvant therapy earlier. In addition, the reduced stress responses and higher levels of immune function among patients undergoing minimally invasive surgery may contribute to a long-term survival advantage.
“These findings address concerns regarding the effectiveness of laparoscopic surgery,” the authors wrote. However, “further studies are necessary to explore the specific mechanisms underlying the positive effect of laparoscopic surgery on OS.”
No outside funding source was noted. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Bone, breath, heart, guts: Eight essential papers in primary care
1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study
Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.
Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.
To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.
The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.
A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.
“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”
At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.
“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis
The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.
However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.
To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.
The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study
Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”
The study authors posed two questions:
- How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?
- Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?
During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.
“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study
The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.
The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.
Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.
“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial
This study assessed the effects of four doses of vitamin D3 supplements on the risk of falls.
The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.
“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study
This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.
The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events
This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.
Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.
“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review
Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.
It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.
As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.
“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.
Dr. Wee and Dr. Chang disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study
Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.
Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.
To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.
The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.
A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.
“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”
At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.
“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis
The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.
However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.
To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.
The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study
Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”
The study authors posed two questions:
- How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?
- Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?
During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.
“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study
The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.
The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.
Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.
“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial
This study assessed the effects of four doses of vitamin D3 supplements on the risk of falls.
The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.
“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study
This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.
The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events
This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.
Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.
“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review
Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.
It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.
As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.
“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.
Dr. Wee and Dr. Chang disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study
Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.
Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.
To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.
The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.
A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.
“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”
At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.
“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis
The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.
However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.
To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.
The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study
Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”
The study authors posed two questions:
- How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?
- Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?
During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.
“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study
The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.
The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.
Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.
“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial
This study assessed the effects of four doses of vitamin D3 supplements on the risk of falls.
The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.
“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study
This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.
The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events
This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.
Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.
“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review
Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.
It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.
As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.
“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.
Dr. Wee and Dr. Chang disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM INTERNAL MEDICINE 2022