User login
Docs using AI? Some love it, most remain wary
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
Your practice was bought out by private equity: Now what?
After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.
“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”
Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.
“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”
Blackstone and Ascension St. John did not respond to this news organization’s request for comment.
TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.
Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”
Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.
Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
What should you expect after PE acquisition?
Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.
Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.
“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”
Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.
“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”
When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.
Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.
In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.
PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.
On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.
“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”
Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.
The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.
“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
How to prepare for and cope with PE partnerships
If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.
“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.
When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.
“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”
Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.
“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”
“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”
For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.
Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.
Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.
In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.
She advises physicians who are unhappy after acquisitions to speak up and stick together.
“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
Why is PE so attracted to health care?
PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.
These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.
When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.
At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.
Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.
Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.
A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.
“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.
Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.
“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.
PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.
A version of this article appeared on Medscape.com.
After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.
“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”
Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.
“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”
Blackstone and Ascension St. John did not respond to this news organization’s request for comment.
TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.
Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”
Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.
Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
What should you expect after PE acquisition?
Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.
Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.
“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”
Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.
“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”
When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.
Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.
In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.
PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.
On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.
“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”
Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.
The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.
“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
How to prepare for and cope with PE partnerships
If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.
“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.
When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.
“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”
Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.
“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”
“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”
For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.
Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.
Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.
In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.
She advises physicians who are unhappy after acquisitions to speak up and stick together.
“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
Why is PE so attracted to health care?
PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.
These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.
When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.
At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.
Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.
Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.
A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.
“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.
Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.
“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.
PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.
A version of this article appeared on Medscape.com.
After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.
“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”
Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.
“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”
Blackstone and Ascension St. John did not respond to this news organization’s request for comment.
TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.
Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”
Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.
Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
What should you expect after PE acquisition?
Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.
Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.
“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”
Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.
“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”
When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.
Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.
In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.
PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.
On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.
“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”
Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.
The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.
“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
How to prepare for and cope with PE partnerships
If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.
“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.
When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.
“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”
Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.
“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”
“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”
For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.
Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.
Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.
In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.
She advises physicians who are unhappy after acquisitions to speak up and stick together.
“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
Why is PE so attracted to health care?
PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.
These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.
When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.
At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.
Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.
Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.
A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.
“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.
Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.
“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.
PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.
A version of this article appeared on Medscape.com.
Battling pediatric cancer outcome disparities, new interventions aim to close gaps
Pediatric oncologist Lena Winestone, MD, recalls treating a 2-year-old leukemia patient who underwent a bone marrow transplant as her only chance for a cure.
The girl’s family, who spoke only Spanish and struggled with literacy, could not pay their rent or afford the girl’s weekly transportation to the hospital for after-transplant care. The family had three other children and lived more than 2 hours from the transplant center, remembers Dr. Winestone, an assistant professor of pediatrics in the division of malignancies and bone & marrow transplant at the University of California, San Francisco.
The hospital’s social worker was able to secure grant support for the family’s housing and worked with the patient’s insurance to arrange for transportation. However, the departure times were rigid, Dr. Winestone said, and the family sometimes had to leave the hospital before the child’s graft vs. host disease (GvHD) treatment was complete for the day.
“If we had not finished her treatment, we had to disconnect her from the machine early,” Dr. Winestone said. “Her mother also had to load her oxygen tanks [three of them], her BiPAP machine, and her tube feeds into the transportation every week in order to make sure she could be safely transported. She was treated for GvHD for almost 2 years, but unfortunately, her GvHD started to affect her lungs and ultimately, she passed away.”
Dr. Winestone says it’s difficult to know whether the girl’s death was directly related to her socioeconomic status, but that it certainly made all aspects of the child’s care more complicated and forced health care providers to adapt her cancer care to accommodate the family’s circumstances.
This story is one of countless cases where socioeconomic status impacted a young patient’s cancer care and likely contributed to a worse outcome.
A 2022 study for example, found that children from marginalized racial/ethnic groups and those living in poverty were more likely to have inferior 5-year overall survival, compared with other children, even when assigned to receive the same initial treatment. Of 696 children with high-risk neuroblastoma, 47% of Hispanic children had a 5-year overall survival (OS), compared with 50% for other non-Hispanic children, and 61% for white non-Hispanic patients. Children on public health insurance (a proxy for household poverty) had a 53% 5-year OS, compared with 63% for children unexposed to household poverty. Pediatric patients exposed to neighborhood poverty had a 54% 5-year OS, compared with 62% for unexposed children.
In another study, children with acute lymphoblastic leukemia who lived in high-poverty areas were more likely to experience early relapse than other patients, despite having the same treatment. Of the 575 children studied, 92% of children from high-poverty areas who relapsed, experienced early relapse, defined as less than 36 months after remission. By comparison, only 48% of other children who relapsed experienced early relapse.
Reasons behind the relapse and survival disparities are multifold, which has led to challenges in addressing the gaps and improving cancer outcomes for poverty-stricken children. A research infrastructure that is largely based on biological, rather than social determinants of health, acts as another barrier, oncologists say.
Historically, interventions to address disparities in pediatric oncology have never been evaluated, said Kira Bona, MD, MPH, a pediatric oncologist at Dana-Farber/Boston Children’s Cancer and Blood Disorders Center. This is in large part because the body of literature illustrating the disparities is relatively new, said Dr. Bona, whose research focuses on poverty-associated outcome disparities in childhood cancer.
However, new efforts aim to change this landscape by using the growing data to develop and analyze possible interventions. A set of three novel interventions led by Dr. Bona and her research team are in the works, some of which have shown promise in early studies.
“Now is the time to begin to actively intervene on disparities in childhood cancer,” Dr. Bona said. “We’re really good at studying genetic mutations in cancer cells that might lead to a risk of relapse, and when we identify those mutations, what we do is intervene. We try new chemotherapy agents, new ways of delivering therapy. We are now at the point where we have identified that social determinants of health may be equally ‘risky’ but we haven’t taken the next step to begin intervening in the same way.”
What is causing disparities in pediatric cancer outcomes?
Lack of access to the health care system is a top contributor to the disparities, although there is no single root cause, said Sharon Castellino, MD, director of the Leukemia and Lymphoma Program at the Aflac Cancer & Blood Disorders Center of Children’s Healthcare of Atlanta, and a professor in the department of pediatrics at Emory University, Atlanta.
Even before cancer diagnosis, Dr. Castellino notes that many children of color and/or of lower socioeconomic status are not receiving regular health care, leading to sicker children and more advanced-stage cancer by the time they are diagnosed.
Lack of insurance is a primary barrier to this access, adds Xu Ji, PhD, MSPH, an assistant professor in the department of pediatrics at Emory University and a member of the Cancer Prevention and Control Research Program at the university’s Winship Cancer Institute.
Studies have long shown that uninsured children are more likely to go without needed care, compared with those with private insurance. Patients of color are at much higher risk of being uninsured than White patients, with the uninsured rates for Hispanic, American Indian, and Alaska Native patients being more than 2.5 times higher than that of White patients.
“We all know that insurance is a strong predictor of health outcomes,” said Dr. Ji, whose research focuses on insurance disparities and gains among cancer patients. “Lack of insurance coverage and therefore lack of access to care along the pediatric cancer continuum from early detection to early diagnosis to timely initiation of treatment to receipt of high-quality treatment to access to recommended survivorship care and even access to palliative and end-of-life care are all very important constructs in the pathway from poverty to ultimate cancer outcomes for children.”
Unstable housing, employment difficulties, and lack of family support can also come into play. Dr. Castellino remembers the case of a 12-year-old cancer patient who entered treatment with advanced-stage Hodgkin Lymphoma. The girl came from a low-income, single-parent household without stable housing. Dr. Castellino said when the child was granted a wish from the Make-a-Wish Foundation, she asked for her own bed.
“We had been working with her every week for 6 months when that request came up,” she recalled. “We said, ‘You don’t have to wait for your make-a-wish, we can get you a bed now.’ We don’t even know the extent of what happens at home for many of these children.”
The impact of toxic stress on child cancer patients is an emerging area of research, said Dr. Winestone, whose research explores racial, ethnic, and socioeconomic disparities in access to care and outcomes of leukemia and lymphoma treatment. For example, Dr. Winestone’s research includes understanding how exposure to poverty or adverse experiences in childhood may influence a patient’s biological response to chemotherapy.
Other contributors to disparities include transportation issues, lack of childcare for other children, literacy, and language barriers. A 2016 study suggests that language barriers negatively impact the quality of informed decision-making and the care experience for Spanish-speaking parents of pediatric cancer patients with limited English proficiency.
Such access issues are also compounded by systemic factors, including a shortage of physicians of color who may be able to forge better trust relationships with families of similar race and ethnicity, Dr. Castellino adds. Lower enrollment of pediatric cancer patients with higher social vulnerabilities in clinical trials is another problem.
“In childhood cancer, I believe our improvements have been built on the backs of prior generations of families and children who have enrolled in trials. We learn things, and the next generation of therapy improves,” Dr. Castellino said. “If you have a whole group of the population not represented in trials, you don’t know what’s driving the fact they may or may not improve.”
Working toward solutions
With such a diverse set of factors fueling outcome gaps, a similarly diverse approach is needed to help bridge the divide, say disparity researchers.
To this end, Dr. Bona and her research team are currently building the first portfolio of health equity interventions, each designed to address a different adverse social determinant of health differently.
The Pediatric Cancer Resource Equity (PediCARE) intervention is a centrally delivered, household material hardship (HMH)–targeted intervention that provides transportation and groceries to low-income pediatric oncology families. The intervention was recently studied in a pilot, randomized, controlled trial at Dana-Farber Cancer Institute and the University of Alabama between May 2019 and August 2021.
Families were first screened for HMH and randomized into receiving either the intervention or usual care for 6 months. The intervention group received groceries via Instacart and transportation to and from the hospital coordinated through the Ride Health platform using Uber or Lyft. For families with their own cars, gas cards were provided. Of the families offered the chance to participate, 100% agreed to participate in the program, and there was 0% attrition in either arm of the program during the 6 months, according to the study findings, which were presented at the 2023 American Society of Clinical Oncology annual meeting in June.
Among families who received the PediCARE intervention, 100% successfully received grocery and transportation resources, 100% reported that it was “easier to buy food for my family,” 85% reported it was easier to get to and from the hospital, and 95% reported they would be “very likely to recommend the intervention to other families,” according to the results.
“The key takeaway is that we had excellent feasibility outcomes,” said Haley Newman, MD, lead author of the study and an attending physician in the division of oncology at The Children’s Hospital of Philadelphia. “From this study, we learned that PediCARE is accessible and feasible in very diverse settings. From this, what we really took away is that PediCARE could be successfully rolled out in a phase 3 randomized trial, which would be the best way to examine efficacy.”
Another initiative in its early stages is Pediatric RISE, a guaranteed income intervention being developed with support from the Children’s Cancer Research Fund, the American Cancer Society, and other donors. The intervention will provide unrestricted cash transfers to low-income families during the early months of chemotherapy, Dr. Bona said. Families are currently being enrolled in a pilot study with a goal of refining the intervention before it’s tested for feasibility and efficacy.
“The goal here is ultimately to evaluate the question: If we are able to successfully provide income support to low-income families going through childhood cancer treatment, might we be able to ameliorate some of the disparities associated with living in poverty that we have already described in childhood cancer,” Dr. Bona said.
Pediatric Assist, a developing intervention centering on benefits, is a third initiative that will soon be evaluated. The intervention will provide newly diagnosed families with systemic access to a centralized benefits counselor who can help them determine which existing government benefits they might be eligible for and assist them in navigating the application process.
“The idea here is that we know many lower-income families in the U.S. are eligible for existing supports, but may not be accessing them because of how incredibly difficult the system is to navigate,” Dr. Bona said. “For example, we know that low-income families may be eligible for SNAP benefits, but figuring out if you are eligible and then applying for SNAP involves multiple, complicated steps that are often infeasible for a parent when their child is admitted to the hospital with a newly diagnosed, life-threatening illness.”
Pilot refinement of the intervention is expected in the fall of 2023.
Overcoming barriers, addressing challenges
Investigators are also making headway in proving that collecting social determinants of health (SDoH) data during existing clinical trials is easily achievable.
Past Children’s Oncology Group trials have collected only race, ethnicity, insurance, and zip code data as proxies for exposure to adverse SDoH. Dr. Winestone and her colleagues recently investigated the feasibility and acceptability of the first COG trial to prospectively embed SDoH data collection.
Of eligible participants, 360 of 413 opted-in to the embedded SDOH aim across 101 COG sites (87.2% consent rate). Among participants, 316 surveys (87.8%) were completed a median of 11 days post enrollment, according to the findings, which were presented at the ASCO annual meeting.
“We’ve come to realize the importance of the social determinants of health [as it pertains] to outcomes, but it has been a process to learn how to effectively collect that data in a large collaborative environment,” said Dr. Winestone. “This abstract demonstrates that patients are very willing to provide this data, and they’re able to do it in an efficient way. People think of these questions as very sensitive and that families may not want to share the answers, but this study demonstrates those presumptions are false.”
The authors hope the findings fuel incorporation of SDoH data collection in future National Clinical Trials Network trials to inform impactful health equity research.
While such research and intervention efforts are gaining momentum, challenges to do the work remain. A lack of research funding and support are among the obstacles, Dr. Winestone said.
To date, much of pediatric cancer work has focused on developing new therapeutic approaches to reach a cure for more patients, she explained.
“While that’s incredibly essential, if we’re creating these approaches that only work for a subset of patients that have resources, we’re contributing to the inequities in the system,” Dr. Winestone said. “Really, [we need] dedicated support to studying how to make sure the interventions we know are effective are reaching all populations, and that the patients are poised to benefit from those interventions by setting them up for success.”
A strong research infrastructure exists to evaluate and support clinical drug trials in pediatric oncology, but the same does not exist for health equity interventions, Dr. Bona adds. A significant question that needs to be addressed is how best to integrate health equity evaluation into existing infrastructure or whether to build a parallel infrastructure.
Despite the challenges, Dr. Bona believes now is exactly the right time to investigate and intervene in poverty as a risk factor for childhood cancer relapse and outcomes. What has led to success in childhood cancer is how pediatric oncology has collaborated across the country to operate clinical drug trials at various centers, all in the same way, to identify which treatments work best, she said.
“We have an opportunity now in pediatrics to take advantage of this highly successful clinical trials research infrastructure to integrate interventions to address disparities in a way that has not been done previously,” she said. “The opportunity to significantly improve survival in childhood cancer by reducing disparities exists if we take this head on from a research and funding perspective and approach social risk factors just as we already know how to approach tumor genomic risk factors.”
Pediatric oncologist Lena Winestone, MD, recalls treating a 2-year-old leukemia patient who underwent a bone marrow transplant as her only chance for a cure.
The girl’s family, who spoke only Spanish and struggled with literacy, could not pay their rent or afford the girl’s weekly transportation to the hospital for after-transplant care. The family had three other children and lived more than 2 hours from the transplant center, remembers Dr. Winestone, an assistant professor of pediatrics in the division of malignancies and bone & marrow transplant at the University of California, San Francisco.
The hospital’s social worker was able to secure grant support for the family’s housing and worked with the patient’s insurance to arrange for transportation. However, the departure times were rigid, Dr. Winestone said, and the family sometimes had to leave the hospital before the child’s graft vs. host disease (GvHD) treatment was complete for the day.
“If we had not finished her treatment, we had to disconnect her from the machine early,” Dr. Winestone said. “Her mother also had to load her oxygen tanks [three of them], her BiPAP machine, and her tube feeds into the transportation every week in order to make sure she could be safely transported. She was treated for GvHD for almost 2 years, but unfortunately, her GvHD started to affect her lungs and ultimately, she passed away.”
Dr. Winestone says it’s difficult to know whether the girl’s death was directly related to her socioeconomic status, but that it certainly made all aspects of the child’s care more complicated and forced health care providers to adapt her cancer care to accommodate the family’s circumstances.
This story is one of countless cases where socioeconomic status impacted a young patient’s cancer care and likely contributed to a worse outcome.
A 2022 study for example, found that children from marginalized racial/ethnic groups and those living in poverty were more likely to have inferior 5-year overall survival, compared with other children, even when assigned to receive the same initial treatment. Of 696 children with high-risk neuroblastoma, 47% of Hispanic children had a 5-year overall survival (OS), compared with 50% for other non-Hispanic children, and 61% for white non-Hispanic patients. Children on public health insurance (a proxy for household poverty) had a 53% 5-year OS, compared with 63% for children unexposed to household poverty. Pediatric patients exposed to neighborhood poverty had a 54% 5-year OS, compared with 62% for unexposed children.
In another study, children with acute lymphoblastic leukemia who lived in high-poverty areas were more likely to experience early relapse than other patients, despite having the same treatment. Of the 575 children studied, 92% of children from high-poverty areas who relapsed, experienced early relapse, defined as less than 36 months after remission. By comparison, only 48% of other children who relapsed experienced early relapse.
Reasons behind the relapse and survival disparities are multifold, which has led to challenges in addressing the gaps and improving cancer outcomes for poverty-stricken children. A research infrastructure that is largely based on biological, rather than social determinants of health, acts as another barrier, oncologists say.
Historically, interventions to address disparities in pediatric oncology have never been evaluated, said Kira Bona, MD, MPH, a pediatric oncologist at Dana-Farber/Boston Children’s Cancer and Blood Disorders Center. This is in large part because the body of literature illustrating the disparities is relatively new, said Dr. Bona, whose research focuses on poverty-associated outcome disparities in childhood cancer.
However, new efforts aim to change this landscape by using the growing data to develop and analyze possible interventions. A set of three novel interventions led by Dr. Bona and her research team are in the works, some of which have shown promise in early studies.
“Now is the time to begin to actively intervene on disparities in childhood cancer,” Dr. Bona said. “We’re really good at studying genetic mutations in cancer cells that might lead to a risk of relapse, and when we identify those mutations, what we do is intervene. We try new chemotherapy agents, new ways of delivering therapy. We are now at the point where we have identified that social determinants of health may be equally ‘risky’ but we haven’t taken the next step to begin intervening in the same way.”
What is causing disparities in pediatric cancer outcomes?
Lack of access to the health care system is a top contributor to the disparities, although there is no single root cause, said Sharon Castellino, MD, director of the Leukemia and Lymphoma Program at the Aflac Cancer & Blood Disorders Center of Children’s Healthcare of Atlanta, and a professor in the department of pediatrics at Emory University, Atlanta.
Even before cancer diagnosis, Dr. Castellino notes that many children of color and/or of lower socioeconomic status are not receiving regular health care, leading to sicker children and more advanced-stage cancer by the time they are diagnosed.
Lack of insurance is a primary barrier to this access, adds Xu Ji, PhD, MSPH, an assistant professor in the department of pediatrics at Emory University and a member of the Cancer Prevention and Control Research Program at the university’s Winship Cancer Institute.
Studies have long shown that uninsured children are more likely to go without needed care, compared with those with private insurance. Patients of color are at much higher risk of being uninsured than White patients, with the uninsured rates for Hispanic, American Indian, and Alaska Native patients being more than 2.5 times higher than that of White patients.
“We all know that insurance is a strong predictor of health outcomes,” said Dr. Ji, whose research focuses on insurance disparities and gains among cancer patients. “Lack of insurance coverage and therefore lack of access to care along the pediatric cancer continuum from early detection to early diagnosis to timely initiation of treatment to receipt of high-quality treatment to access to recommended survivorship care and even access to palliative and end-of-life care are all very important constructs in the pathway from poverty to ultimate cancer outcomes for children.”
Unstable housing, employment difficulties, and lack of family support can also come into play. Dr. Castellino remembers the case of a 12-year-old cancer patient who entered treatment with advanced-stage Hodgkin Lymphoma. The girl came from a low-income, single-parent household without stable housing. Dr. Castellino said when the child was granted a wish from the Make-a-Wish Foundation, she asked for her own bed.
“We had been working with her every week for 6 months when that request came up,” she recalled. “We said, ‘You don’t have to wait for your make-a-wish, we can get you a bed now.’ We don’t even know the extent of what happens at home for many of these children.”
The impact of toxic stress on child cancer patients is an emerging area of research, said Dr. Winestone, whose research explores racial, ethnic, and socioeconomic disparities in access to care and outcomes of leukemia and lymphoma treatment. For example, Dr. Winestone’s research includes understanding how exposure to poverty or adverse experiences in childhood may influence a patient’s biological response to chemotherapy.
Other contributors to disparities include transportation issues, lack of childcare for other children, literacy, and language barriers. A 2016 study suggests that language barriers negatively impact the quality of informed decision-making and the care experience for Spanish-speaking parents of pediatric cancer patients with limited English proficiency.
Such access issues are also compounded by systemic factors, including a shortage of physicians of color who may be able to forge better trust relationships with families of similar race and ethnicity, Dr. Castellino adds. Lower enrollment of pediatric cancer patients with higher social vulnerabilities in clinical trials is another problem.
“In childhood cancer, I believe our improvements have been built on the backs of prior generations of families and children who have enrolled in trials. We learn things, and the next generation of therapy improves,” Dr. Castellino said. “If you have a whole group of the population not represented in trials, you don’t know what’s driving the fact they may or may not improve.”
Working toward solutions
With such a diverse set of factors fueling outcome gaps, a similarly diverse approach is needed to help bridge the divide, say disparity researchers.
To this end, Dr. Bona and her research team are currently building the first portfolio of health equity interventions, each designed to address a different adverse social determinant of health differently.
The Pediatric Cancer Resource Equity (PediCARE) intervention is a centrally delivered, household material hardship (HMH)–targeted intervention that provides transportation and groceries to low-income pediatric oncology families. The intervention was recently studied in a pilot, randomized, controlled trial at Dana-Farber Cancer Institute and the University of Alabama between May 2019 and August 2021.
Families were first screened for HMH and randomized into receiving either the intervention or usual care for 6 months. The intervention group received groceries via Instacart and transportation to and from the hospital coordinated through the Ride Health platform using Uber or Lyft. For families with their own cars, gas cards were provided. Of the families offered the chance to participate, 100% agreed to participate in the program, and there was 0% attrition in either arm of the program during the 6 months, according to the study findings, which were presented at the 2023 American Society of Clinical Oncology annual meeting in June.
Among families who received the PediCARE intervention, 100% successfully received grocery and transportation resources, 100% reported that it was “easier to buy food for my family,” 85% reported it was easier to get to and from the hospital, and 95% reported they would be “very likely to recommend the intervention to other families,” according to the results.
“The key takeaway is that we had excellent feasibility outcomes,” said Haley Newman, MD, lead author of the study and an attending physician in the division of oncology at The Children’s Hospital of Philadelphia. “From this study, we learned that PediCARE is accessible and feasible in very diverse settings. From this, what we really took away is that PediCARE could be successfully rolled out in a phase 3 randomized trial, which would be the best way to examine efficacy.”
Another initiative in its early stages is Pediatric RISE, a guaranteed income intervention being developed with support from the Children’s Cancer Research Fund, the American Cancer Society, and other donors. The intervention will provide unrestricted cash transfers to low-income families during the early months of chemotherapy, Dr. Bona said. Families are currently being enrolled in a pilot study with a goal of refining the intervention before it’s tested for feasibility and efficacy.
“The goal here is ultimately to evaluate the question: If we are able to successfully provide income support to low-income families going through childhood cancer treatment, might we be able to ameliorate some of the disparities associated with living in poverty that we have already described in childhood cancer,” Dr. Bona said.
Pediatric Assist, a developing intervention centering on benefits, is a third initiative that will soon be evaluated. The intervention will provide newly diagnosed families with systemic access to a centralized benefits counselor who can help them determine which existing government benefits they might be eligible for and assist them in navigating the application process.
“The idea here is that we know many lower-income families in the U.S. are eligible for existing supports, but may not be accessing them because of how incredibly difficult the system is to navigate,” Dr. Bona said. “For example, we know that low-income families may be eligible for SNAP benefits, but figuring out if you are eligible and then applying for SNAP involves multiple, complicated steps that are often infeasible for a parent when their child is admitted to the hospital with a newly diagnosed, life-threatening illness.”
Pilot refinement of the intervention is expected in the fall of 2023.
Overcoming barriers, addressing challenges
Investigators are also making headway in proving that collecting social determinants of health (SDoH) data during existing clinical trials is easily achievable.
Past Children’s Oncology Group trials have collected only race, ethnicity, insurance, and zip code data as proxies for exposure to adverse SDoH. Dr. Winestone and her colleagues recently investigated the feasibility and acceptability of the first COG trial to prospectively embed SDoH data collection.
Of eligible participants, 360 of 413 opted-in to the embedded SDOH aim across 101 COG sites (87.2% consent rate). Among participants, 316 surveys (87.8%) were completed a median of 11 days post enrollment, according to the findings, which were presented at the ASCO annual meeting.
“We’ve come to realize the importance of the social determinants of health [as it pertains] to outcomes, but it has been a process to learn how to effectively collect that data in a large collaborative environment,” said Dr. Winestone. “This abstract demonstrates that patients are very willing to provide this data, and they’re able to do it in an efficient way. People think of these questions as very sensitive and that families may not want to share the answers, but this study demonstrates those presumptions are false.”
The authors hope the findings fuel incorporation of SDoH data collection in future National Clinical Trials Network trials to inform impactful health equity research.
While such research and intervention efforts are gaining momentum, challenges to do the work remain. A lack of research funding and support are among the obstacles, Dr. Winestone said.
To date, much of pediatric cancer work has focused on developing new therapeutic approaches to reach a cure for more patients, she explained.
“While that’s incredibly essential, if we’re creating these approaches that only work for a subset of patients that have resources, we’re contributing to the inequities in the system,” Dr. Winestone said. “Really, [we need] dedicated support to studying how to make sure the interventions we know are effective are reaching all populations, and that the patients are poised to benefit from those interventions by setting them up for success.”
A strong research infrastructure exists to evaluate and support clinical drug trials in pediatric oncology, but the same does not exist for health equity interventions, Dr. Bona adds. A significant question that needs to be addressed is how best to integrate health equity evaluation into existing infrastructure or whether to build a parallel infrastructure.
Despite the challenges, Dr. Bona believes now is exactly the right time to investigate and intervene in poverty as a risk factor for childhood cancer relapse and outcomes. What has led to success in childhood cancer is how pediatric oncology has collaborated across the country to operate clinical drug trials at various centers, all in the same way, to identify which treatments work best, she said.
“We have an opportunity now in pediatrics to take advantage of this highly successful clinical trials research infrastructure to integrate interventions to address disparities in a way that has not been done previously,” she said. “The opportunity to significantly improve survival in childhood cancer by reducing disparities exists if we take this head on from a research and funding perspective and approach social risk factors just as we already know how to approach tumor genomic risk factors.”
Pediatric oncologist Lena Winestone, MD, recalls treating a 2-year-old leukemia patient who underwent a bone marrow transplant as her only chance for a cure.
The girl’s family, who spoke only Spanish and struggled with literacy, could not pay their rent or afford the girl’s weekly transportation to the hospital for after-transplant care. The family had three other children and lived more than 2 hours from the transplant center, remembers Dr. Winestone, an assistant professor of pediatrics in the division of malignancies and bone & marrow transplant at the University of California, San Francisco.
The hospital’s social worker was able to secure grant support for the family’s housing and worked with the patient’s insurance to arrange for transportation. However, the departure times were rigid, Dr. Winestone said, and the family sometimes had to leave the hospital before the child’s graft vs. host disease (GvHD) treatment was complete for the day.
“If we had not finished her treatment, we had to disconnect her from the machine early,” Dr. Winestone said. “Her mother also had to load her oxygen tanks [three of them], her BiPAP machine, and her tube feeds into the transportation every week in order to make sure she could be safely transported. She was treated for GvHD for almost 2 years, but unfortunately, her GvHD started to affect her lungs and ultimately, she passed away.”
Dr. Winestone says it’s difficult to know whether the girl’s death was directly related to her socioeconomic status, but that it certainly made all aspects of the child’s care more complicated and forced health care providers to adapt her cancer care to accommodate the family’s circumstances.
This story is one of countless cases where socioeconomic status impacted a young patient’s cancer care and likely contributed to a worse outcome.
A 2022 study for example, found that children from marginalized racial/ethnic groups and those living in poverty were more likely to have inferior 5-year overall survival, compared with other children, even when assigned to receive the same initial treatment. Of 696 children with high-risk neuroblastoma, 47% of Hispanic children had a 5-year overall survival (OS), compared with 50% for other non-Hispanic children, and 61% for white non-Hispanic patients. Children on public health insurance (a proxy for household poverty) had a 53% 5-year OS, compared with 63% for children unexposed to household poverty. Pediatric patients exposed to neighborhood poverty had a 54% 5-year OS, compared with 62% for unexposed children.
In another study, children with acute lymphoblastic leukemia who lived in high-poverty areas were more likely to experience early relapse than other patients, despite having the same treatment. Of the 575 children studied, 92% of children from high-poverty areas who relapsed, experienced early relapse, defined as less than 36 months after remission. By comparison, only 48% of other children who relapsed experienced early relapse.
Reasons behind the relapse and survival disparities are multifold, which has led to challenges in addressing the gaps and improving cancer outcomes for poverty-stricken children. A research infrastructure that is largely based on biological, rather than social determinants of health, acts as another barrier, oncologists say.
Historically, interventions to address disparities in pediatric oncology have never been evaluated, said Kira Bona, MD, MPH, a pediatric oncologist at Dana-Farber/Boston Children’s Cancer and Blood Disorders Center. This is in large part because the body of literature illustrating the disparities is relatively new, said Dr. Bona, whose research focuses on poverty-associated outcome disparities in childhood cancer.
However, new efforts aim to change this landscape by using the growing data to develop and analyze possible interventions. A set of three novel interventions led by Dr. Bona and her research team are in the works, some of which have shown promise in early studies.
“Now is the time to begin to actively intervene on disparities in childhood cancer,” Dr. Bona said. “We’re really good at studying genetic mutations in cancer cells that might lead to a risk of relapse, and when we identify those mutations, what we do is intervene. We try new chemotherapy agents, new ways of delivering therapy. We are now at the point where we have identified that social determinants of health may be equally ‘risky’ but we haven’t taken the next step to begin intervening in the same way.”
What is causing disparities in pediatric cancer outcomes?
Lack of access to the health care system is a top contributor to the disparities, although there is no single root cause, said Sharon Castellino, MD, director of the Leukemia and Lymphoma Program at the Aflac Cancer & Blood Disorders Center of Children’s Healthcare of Atlanta, and a professor in the department of pediatrics at Emory University, Atlanta.
Even before cancer diagnosis, Dr. Castellino notes that many children of color and/or of lower socioeconomic status are not receiving regular health care, leading to sicker children and more advanced-stage cancer by the time they are diagnosed.
Lack of insurance is a primary barrier to this access, adds Xu Ji, PhD, MSPH, an assistant professor in the department of pediatrics at Emory University and a member of the Cancer Prevention and Control Research Program at the university’s Winship Cancer Institute.
Studies have long shown that uninsured children are more likely to go without needed care, compared with those with private insurance. Patients of color are at much higher risk of being uninsured than White patients, with the uninsured rates for Hispanic, American Indian, and Alaska Native patients being more than 2.5 times higher than that of White patients.
“We all know that insurance is a strong predictor of health outcomes,” said Dr. Ji, whose research focuses on insurance disparities and gains among cancer patients. “Lack of insurance coverage and therefore lack of access to care along the pediatric cancer continuum from early detection to early diagnosis to timely initiation of treatment to receipt of high-quality treatment to access to recommended survivorship care and even access to palliative and end-of-life care are all very important constructs in the pathway from poverty to ultimate cancer outcomes for children.”
Unstable housing, employment difficulties, and lack of family support can also come into play. Dr. Castellino remembers the case of a 12-year-old cancer patient who entered treatment with advanced-stage Hodgkin Lymphoma. The girl came from a low-income, single-parent household without stable housing. Dr. Castellino said when the child was granted a wish from the Make-a-Wish Foundation, she asked for her own bed.
“We had been working with her every week for 6 months when that request came up,” she recalled. “We said, ‘You don’t have to wait for your make-a-wish, we can get you a bed now.’ We don’t even know the extent of what happens at home for many of these children.”
The impact of toxic stress on child cancer patients is an emerging area of research, said Dr. Winestone, whose research explores racial, ethnic, and socioeconomic disparities in access to care and outcomes of leukemia and lymphoma treatment. For example, Dr. Winestone’s research includes understanding how exposure to poverty or adverse experiences in childhood may influence a patient’s biological response to chemotherapy.
Other contributors to disparities include transportation issues, lack of childcare for other children, literacy, and language barriers. A 2016 study suggests that language barriers negatively impact the quality of informed decision-making and the care experience for Spanish-speaking parents of pediatric cancer patients with limited English proficiency.
Such access issues are also compounded by systemic factors, including a shortage of physicians of color who may be able to forge better trust relationships with families of similar race and ethnicity, Dr. Castellino adds. Lower enrollment of pediatric cancer patients with higher social vulnerabilities in clinical trials is another problem.
“In childhood cancer, I believe our improvements have been built on the backs of prior generations of families and children who have enrolled in trials. We learn things, and the next generation of therapy improves,” Dr. Castellino said. “If you have a whole group of the population not represented in trials, you don’t know what’s driving the fact they may or may not improve.”
Working toward solutions
With such a diverse set of factors fueling outcome gaps, a similarly diverse approach is needed to help bridge the divide, say disparity researchers.
To this end, Dr. Bona and her research team are currently building the first portfolio of health equity interventions, each designed to address a different adverse social determinant of health differently.
The Pediatric Cancer Resource Equity (PediCARE) intervention is a centrally delivered, household material hardship (HMH)–targeted intervention that provides transportation and groceries to low-income pediatric oncology families. The intervention was recently studied in a pilot, randomized, controlled trial at Dana-Farber Cancer Institute and the University of Alabama between May 2019 and August 2021.
Families were first screened for HMH and randomized into receiving either the intervention or usual care for 6 months. The intervention group received groceries via Instacart and transportation to and from the hospital coordinated through the Ride Health platform using Uber or Lyft. For families with their own cars, gas cards were provided. Of the families offered the chance to participate, 100% agreed to participate in the program, and there was 0% attrition in either arm of the program during the 6 months, according to the study findings, which were presented at the 2023 American Society of Clinical Oncology annual meeting in June.
Among families who received the PediCARE intervention, 100% successfully received grocery and transportation resources, 100% reported that it was “easier to buy food for my family,” 85% reported it was easier to get to and from the hospital, and 95% reported they would be “very likely to recommend the intervention to other families,” according to the results.
“The key takeaway is that we had excellent feasibility outcomes,” said Haley Newman, MD, lead author of the study and an attending physician in the division of oncology at The Children’s Hospital of Philadelphia. “From this study, we learned that PediCARE is accessible and feasible in very diverse settings. From this, what we really took away is that PediCARE could be successfully rolled out in a phase 3 randomized trial, which would be the best way to examine efficacy.”
Another initiative in its early stages is Pediatric RISE, a guaranteed income intervention being developed with support from the Children’s Cancer Research Fund, the American Cancer Society, and other donors. The intervention will provide unrestricted cash transfers to low-income families during the early months of chemotherapy, Dr. Bona said. Families are currently being enrolled in a pilot study with a goal of refining the intervention before it’s tested for feasibility and efficacy.
“The goal here is ultimately to evaluate the question: If we are able to successfully provide income support to low-income families going through childhood cancer treatment, might we be able to ameliorate some of the disparities associated with living in poverty that we have already described in childhood cancer,” Dr. Bona said.
Pediatric Assist, a developing intervention centering on benefits, is a third initiative that will soon be evaluated. The intervention will provide newly diagnosed families with systemic access to a centralized benefits counselor who can help them determine which existing government benefits they might be eligible for and assist them in navigating the application process.
“The idea here is that we know many lower-income families in the U.S. are eligible for existing supports, but may not be accessing them because of how incredibly difficult the system is to navigate,” Dr. Bona said. “For example, we know that low-income families may be eligible for SNAP benefits, but figuring out if you are eligible and then applying for SNAP involves multiple, complicated steps that are often infeasible for a parent when their child is admitted to the hospital with a newly diagnosed, life-threatening illness.”
Pilot refinement of the intervention is expected in the fall of 2023.
Overcoming barriers, addressing challenges
Investigators are also making headway in proving that collecting social determinants of health (SDoH) data during existing clinical trials is easily achievable.
Past Children’s Oncology Group trials have collected only race, ethnicity, insurance, and zip code data as proxies for exposure to adverse SDoH. Dr. Winestone and her colleagues recently investigated the feasibility and acceptability of the first COG trial to prospectively embed SDoH data collection.
Of eligible participants, 360 of 413 opted-in to the embedded SDOH aim across 101 COG sites (87.2% consent rate). Among participants, 316 surveys (87.8%) were completed a median of 11 days post enrollment, according to the findings, which were presented at the ASCO annual meeting.
“We’ve come to realize the importance of the social determinants of health [as it pertains] to outcomes, but it has been a process to learn how to effectively collect that data in a large collaborative environment,” said Dr. Winestone. “This abstract demonstrates that patients are very willing to provide this data, and they’re able to do it in an efficient way. People think of these questions as very sensitive and that families may not want to share the answers, but this study demonstrates those presumptions are false.”
The authors hope the findings fuel incorporation of SDoH data collection in future National Clinical Trials Network trials to inform impactful health equity research.
While such research and intervention efforts are gaining momentum, challenges to do the work remain. A lack of research funding and support are among the obstacles, Dr. Winestone said.
To date, much of pediatric cancer work has focused on developing new therapeutic approaches to reach a cure for more patients, she explained.
“While that’s incredibly essential, if we’re creating these approaches that only work for a subset of patients that have resources, we’re contributing to the inequities in the system,” Dr. Winestone said. “Really, [we need] dedicated support to studying how to make sure the interventions we know are effective are reaching all populations, and that the patients are poised to benefit from those interventions by setting them up for success.”
A strong research infrastructure exists to evaluate and support clinical drug trials in pediatric oncology, but the same does not exist for health equity interventions, Dr. Bona adds. A significant question that needs to be addressed is how best to integrate health equity evaluation into existing infrastructure or whether to build a parallel infrastructure.
Despite the challenges, Dr. Bona believes now is exactly the right time to investigate and intervene in poverty as a risk factor for childhood cancer relapse and outcomes. What has led to success in childhood cancer is how pediatric oncology has collaborated across the country to operate clinical drug trials at various centers, all in the same way, to identify which treatments work best, she said.
“We have an opportunity now in pediatrics to take advantage of this highly successful clinical trials research infrastructure to integrate interventions to address disparities in a way that has not been done previously,” she said. “The opportunity to significantly improve survival in childhood cancer by reducing disparities exists if we take this head on from a research and funding perspective and approach social risk factors just as we already know how to approach tumor genomic risk factors.”
Severe obesity and postmenopausal status associated with increased migraine frequency
Key clinical point: Severe obesity (body mass index [BMI] > 40 kg/m2) and postmenopausal status were associated with a significantly higher migraine frequency, with severe obesity also being associated with higher migraine severity.
Major finding: Migraine headache index scores (165.5 vs 105.5; P = .01) and the number of migraine headaches per month (P = .007) were significantly higher in patients with severe obesity vs those with healthy weight (BMI 18.5-24.9 kg/m2), with the number of migraine headaches per month being significantly higher among postmenopausal vs premenopausal women (mean 23 vs 19 days; P = .02).
Study details: Findings are from a retrospective cohort study including 223 patients with refractory migraine.
Disclosures: This study did not receive any specific funding. The authors declared no competing interests.
Source: Saffari TM et al. Severe obesity is associated with increased migraine severity and frequency: A retrospective cohort study. J Clin Neurosci. 2023;115:8-13 (Jul 14). doi: 10.1016/j.jocn.2023.07.007
Key clinical point: Severe obesity (body mass index [BMI] > 40 kg/m2) and postmenopausal status were associated with a significantly higher migraine frequency, with severe obesity also being associated with higher migraine severity.
Major finding: Migraine headache index scores (165.5 vs 105.5; P = .01) and the number of migraine headaches per month (P = .007) were significantly higher in patients with severe obesity vs those with healthy weight (BMI 18.5-24.9 kg/m2), with the number of migraine headaches per month being significantly higher among postmenopausal vs premenopausal women (mean 23 vs 19 days; P = .02).
Study details: Findings are from a retrospective cohort study including 223 patients with refractory migraine.
Disclosures: This study did not receive any specific funding. The authors declared no competing interests.
Source: Saffari TM et al. Severe obesity is associated with increased migraine severity and frequency: A retrospective cohort study. J Clin Neurosci. 2023;115:8-13 (Jul 14). doi: 10.1016/j.jocn.2023.07.007
Key clinical point: Severe obesity (body mass index [BMI] > 40 kg/m2) and postmenopausal status were associated with a significantly higher migraine frequency, with severe obesity also being associated with higher migraine severity.
Major finding: Migraine headache index scores (165.5 vs 105.5; P = .01) and the number of migraine headaches per month (P = .007) were significantly higher in patients with severe obesity vs those with healthy weight (BMI 18.5-24.9 kg/m2), with the number of migraine headaches per month being significantly higher among postmenopausal vs premenopausal women (mean 23 vs 19 days; P = .02).
Study details: Findings are from a retrospective cohort study including 223 patients with refractory migraine.
Disclosures: This study did not receive any specific funding. The authors declared no competing interests.
Source: Saffari TM et al. Severe obesity is associated with increased migraine severity and frequency: A retrospective cohort study. J Clin Neurosci. 2023;115:8-13 (Jul 14). doi: 10.1016/j.jocn.2023.07.007
Higher dietary zinc intake and risk for migraine: Is there a link?
Key clinical point: Higher dietary intake of zinc was negatively associated with the risk for migraine in adults, with the association being more prominent among those age 20-50 years.
Major finding: Compared with participants in the lowest quintile of dietary zinc consumption (≤ 5.93 mg/day), the risk for migraine was lower among those in the higher quintiles of dietary zinc consumption (5.94-8.38 mg/day: adjusted odds ratio [aOR] 0.73; P = .004; 8.39-11.26 mg/day: aOR 0.72; P = .02; and 11.27-15.75 mg/day: aOR 0.76; P = .04), with a non-linear association observed between zinc intake and migraine in the age 20-50 years group (P < .001).
Study details: This cross-sectional study included 9849 adult participants (age ≥ 20 years), of whom 1963 (19.93%) had migraine.
Disclosures: This study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangxi Province, and Jiangxi Provincial Department of Education Science and Technology Program Project. No potential conflicts of interest were declared.
Source: Zheng H et al. Dietary zinc intake in relation to migraine among adults: A cross sectional study of NHANES 1999-2004. Nutr Neurosci. 2023 (Aug 4). doi: 10.1080/1028415X.2023.2243678
Key clinical point: Higher dietary intake of zinc was negatively associated with the risk for migraine in adults, with the association being more prominent among those age 20-50 years.
Major finding: Compared with participants in the lowest quintile of dietary zinc consumption (≤ 5.93 mg/day), the risk for migraine was lower among those in the higher quintiles of dietary zinc consumption (5.94-8.38 mg/day: adjusted odds ratio [aOR] 0.73; P = .004; 8.39-11.26 mg/day: aOR 0.72; P = .02; and 11.27-15.75 mg/day: aOR 0.76; P = .04), with a non-linear association observed between zinc intake and migraine in the age 20-50 years group (P < .001).
Study details: This cross-sectional study included 9849 adult participants (age ≥ 20 years), of whom 1963 (19.93%) had migraine.
Disclosures: This study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangxi Province, and Jiangxi Provincial Department of Education Science and Technology Program Project. No potential conflicts of interest were declared.
Source: Zheng H et al. Dietary zinc intake in relation to migraine among adults: A cross sectional study of NHANES 1999-2004. Nutr Neurosci. 2023 (Aug 4). doi: 10.1080/1028415X.2023.2243678
Key clinical point: Higher dietary intake of zinc was negatively associated with the risk for migraine in adults, with the association being more prominent among those age 20-50 years.
Major finding: Compared with participants in the lowest quintile of dietary zinc consumption (≤ 5.93 mg/day), the risk for migraine was lower among those in the higher quintiles of dietary zinc consumption (5.94-8.38 mg/day: adjusted odds ratio [aOR] 0.73; P = .004; 8.39-11.26 mg/day: aOR 0.72; P = .02; and 11.27-15.75 mg/day: aOR 0.76; P = .04), with a non-linear association observed between zinc intake and migraine in the age 20-50 years group (P < .001).
Study details: This cross-sectional study included 9849 adult participants (age ≥ 20 years), of whom 1963 (19.93%) had migraine.
Disclosures: This study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangxi Province, and Jiangxi Provincial Department of Education Science and Technology Program Project. No potential conflicts of interest were declared.
Source: Zheng H et al. Dietary zinc intake in relation to migraine among adults: A cross sectional study of NHANES 1999-2004. Nutr Neurosci. 2023 (Aug 4). doi: 10.1080/1028415X.2023.2243678
Migraine tied to a greater risk for rheumatoid arthritis
Key clinical point: Patients with migraine are at a greater risk of experiencing rheumatoid arthritis (RA) attacks, with the risk being prominently higher among those having migraine without aura.
Major finding: The risk for RA was 1.94 times higher in patients with migraine vs control individuals (adjusted odds ratio [aOR] 1.94; 95% CI 1.74-2.17), with the risk being prominent in those with migraine without aura (aOR 1.49; 95% CI 1.35-1.64).
Study details: The data come from a meta-analysis of five studies including 321,877 participants.
Disclosures: This study did not disclose the funding source. The authors declared no competing interests.
Source: Tian D et al. Migraine and risk of rheumatoid arthritis: A systematic review and meta-analysis of observational studies. Heliyon. 2023;9(8):e18430 (Jul 18). doi: 10.1016/j.heliyon.2023.e18430
Key clinical point: Patients with migraine are at a greater risk of experiencing rheumatoid arthritis (RA) attacks, with the risk being prominently higher among those having migraine without aura.
Major finding: The risk for RA was 1.94 times higher in patients with migraine vs control individuals (adjusted odds ratio [aOR] 1.94; 95% CI 1.74-2.17), with the risk being prominent in those with migraine without aura (aOR 1.49; 95% CI 1.35-1.64).
Study details: The data come from a meta-analysis of five studies including 321,877 participants.
Disclosures: This study did not disclose the funding source. The authors declared no competing interests.
Source: Tian D et al. Migraine and risk of rheumatoid arthritis: A systematic review and meta-analysis of observational studies. Heliyon. 2023;9(8):e18430 (Jul 18). doi: 10.1016/j.heliyon.2023.e18430
Key clinical point: Patients with migraine are at a greater risk of experiencing rheumatoid arthritis (RA) attacks, with the risk being prominently higher among those having migraine without aura.
Major finding: The risk for RA was 1.94 times higher in patients with migraine vs control individuals (adjusted odds ratio [aOR] 1.94; 95% CI 1.74-2.17), with the risk being prominent in those with migraine without aura (aOR 1.49; 95% CI 1.35-1.64).
Study details: The data come from a meta-analysis of five studies including 321,877 participants.
Disclosures: This study did not disclose the funding source. The authors declared no competing interests.
Source: Tian D et al. Migraine and risk of rheumatoid arthritis: A systematic review and meta-analysis of observational studies. Heliyon. 2023;9(8):e18430 (Jul 18). doi: 10.1016/j.heliyon.2023.e18430
Ubrogepant effective for acute treatment of migraine when taken with onabotulinumtoxinA
Key clinical point: Ubrogepant in combination with onabotulinumtoxinA led to meaningful pain relief and return to normal function at 2 and 4 hours post-dose in patients with self-identified migraine.
Major finding: Overall, 53.3% and 76.2% of patients achieved meaningful pain relief and 25.4% and 45.9% of patients achieved returned to normal function at 2 and 4 hours post-dose after the first treated attack, respectively.
Study details: The data come from a prospective real-world study including 122 patients with migraine (age ≥ 18 years) who received ubrogepant in combination with onabotulinumtoxinA.
Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). Some authors declared receiving research support, royalties, or honoraria from, and serving as consultants and advisory board members for various sources, including AbbVie. Three authors declared being employees of or holding stocks in AbbVie.
Source: Manack Adams A et al. Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: Results from the COURAGE Study. J Headache Pain. 2023;24:102 (Aug 3). doi: 10.1186/s10194-023-01622-0
Key clinical point: Ubrogepant in combination with onabotulinumtoxinA led to meaningful pain relief and return to normal function at 2 and 4 hours post-dose in patients with self-identified migraine.
Major finding: Overall, 53.3% and 76.2% of patients achieved meaningful pain relief and 25.4% and 45.9% of patients achieved returned to normal function at 2 and 4 hours post-dose after the first treated attack, respectively.
Study details: The data come from a prospective real-world study including 122 patients with migraine (age ≥ 18 years) who received ubrogepant in combination with onabotulinumtoxinA.
Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). Some authors declared receiving research support, royalties, or honoraria from, and serving as consultants and advisory board members for various sources, including AbbVie. Three authors declared being employees of or holding stocks in AbbVie.
Source: Manack Adams A et al. Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: Results from the COURAGE Study. J Headache Pain. 2023;24:102 (Aug 3). doi: 10.1186/s10194-023-01622-0
Key clinical point: Ubrogepant in combination with onabotulinumtoxinA led to meaningful pain relief and return to normal function at 2 and 4 hours post-dose in patients with self-identified migraine.
Major finding: Overall, 53.3% and 76.2% of patients achieved meaningful pain relief and 25.4% and 45.9% of patients achieved returned to normal function at 2 and 4 hours post-dose after the first treated attack, respectively.
Study details: The data come from a prospective real-world study including 122 patients with migraine (age ≥ 18 years) who received ubrogepant in combination with onabotulinumtoxinA.
Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). Some authors declared receiving research support, royalties, or honoraria from, and serving as consultants and advisory board members for various sources, including AbbVie. Three authors declared being employees of or holding stocks in AbbVie.
Source: Manack Adams A et al. Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: Results from the COURAGE Study. J Headache Pain. 2023;24:102 (Aug 3). doi: 10.1186/s10194-023-01622-0
Add-on MIND outperforms treatment as usual in chronic migraine and medication-overuse headache
Key clinical point: Addition of mindfulness-based intervention (MIND) comprising 6 weekly sessions and 7-10 minutes daily self-practice to treatment as usual (TaU) led to greater improvements in clinical outcomes compared with TaU alone in patients with chronic migraine (CM) and medication-overuse headache (MOH).
Major finding: TaU-plus-MIND outperformed TaU in the achievement of ≥ 50% reduction in headache frequency at 12 months (P < .0001), percentage reduction in headache days (P = .0001), and reduction in intake of total medication and non-steroidal anti-inflammatory drugs (P = .0001).
Study details: Finding are from MIND-CM, a phase 3 trial including 177 patients with CM and MOH who were randomly assigned to receive either TaU (including withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis; n = 89) or MIND added to TaU (n = 88).
Disclosures: This study was funded by the Italian Ministry of Health. The authors declared no conflicts of interest.
Source: Grazzi L at al. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: A phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023;24 (Jul 14). doi: 10.1186/s10194-023-01630-0
Key clinical point: Addition of mindfulness-based intervention (MIND) comprising 6 weekly sessions and 7-10 minutes daily self-practice to treatment as usual (TaU) led to greater improvements in clinical outcomes compared with TaU alone in patients with chronic migraine (CM) and medication-overuse headache (MOH).
Major finding: TaU-plus-MIND outperformed TaU in the achievement of ≥ 50% reduction in headache frequency at 12 months (P < .0001), percentage reduction in headache days (P = .0001), and reduction in intake of total medication and non-steroidal anti-inflammatory drugs (P = .0001).
Study details: Finding are from MIND-CM, a phase 3 trial including 177 patients with CM and MOH who were randomly assigned to receive either TaU (including withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis; n = 89) or MIND added to TaU (n = 88).
Disclosures: This study was funded by the Italian Ministry of Health. The authors declared no conflicts of interest.
Source: Grazzi L at al. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: A phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023;24 (Jul 14). doi: 10.1186/s10194-023-01630-0
Key clinical point: Addition of mindfulness-based intervention (MIND) comprising 6 weekly sessions and 7-10 minutes daily self-practice to treatment as usual (TaU) led to greater improvements in clinical outcomes compared with TaU alone in patients with chronic migraine (CM) and medication-overuse headache (MOH).
Major finding: TaU-plus-MIND outperformed TaU in the achievement of ≥ 50% reduction in headache frequency at 12 months (P < .0001), percentage reduction in headache days (P = .0001), and reduction in intake of total medication and non-steroidal anti-inflammatory drugs (P = .0001).
Study details: Finding are from MIND-CM, a phase 3 trial including 177 patients with CM and MOH who were randomly assigned to receive either TaU (including withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis; n = 89) or MIND added to TaU (n = 88).
Disclosures: This study was funded by the Italian Ministry of Health. The authors declared no conflicts of interest.
Source: Grazzi L at al. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: A phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023;24 (Jul 14). doi: 10.1186/s10194-023-01630-0
Triptans and ergotamine lower ischemic cardio-cerebrovascular diseases risk in migraine
Key clinical point: Migraine increased the risk for ischemic cardio-cerebrovascular diseases (CCVD), but the risk was lower in those treated with triptans or ergotamine (TE).
Major finding: Compared with patients having non-migraine headaches (NMH), the risk for ischemic CCVD was higher in patients with migraine receiving TE (men: adjusted hazard ratio [aHR] 1.18; 95% CI 1.01-1.39; women: aHR 1.22; 95% CI 1.09-1.37) and in those receiving neither triptans nor ergotamine (NTNE; men: aHR 1.39; 95% CI 1.28-1.50; women: aHR 1.53; 95% CI 1.42-1.65). The risk for ischemic CCVD was lower in the TE vs NTNE group (men: aHR 0.86; 95% CI 0.73-0.999; women: aHR 0.80; 95% CI 0.72-0.88).
Study details: This study included 62,272 patients with migraine or NMH. Patients with migraine were categorized into those who received ≥ 1 prescriptions for TE (n = 4959) and those who received NTNE (n = 37,624).
Disclosures: This study received no specific funding. The authors declared no conflicts of interest.
Source: Kim Y et al. Association between migraine and ischemic cardio-cerebrovascular disease (CCVD) and effects of triptans and ergotamine on the risk of ischemic CCVD in patients with migraine in the Korean NHIS-HEALS cohort. Clin Drug Investig. 2023;43(7):541-550 (Jul 17). doi: 10.1007/s40261-023-01290-7
Key clinical point: Migraine increased the risk for ischemic cardio-cerebrovascular diseases (CCVD), but the risk was lower in those treated with triptans or ergotamine (TE).
Major finding: Compared with patients having non-migraine headaches (NMH), the risk for ischemic CCVD was higher in patients with migraine receiving TE (men: adjusted hazard ratio [aHR] 1.18; 95% CI 1.01-1.39; women: aHR 1.22; 95% CI 1.09-1.37) and in those receiving neither triptans nor ergotamine (NTNE; men: aHR 1.39; 95% CI 1.28-1.50; women: aHR 1.53; 95% CI 1.42-1.65). The risk for ischemic CCVD was lower in the TE vs NTNE group (men: aHR 0.86; 95% CI 0.73-0.999; women: aHR 0.80; 95% CI 0.72-0.88).
Study details: This study included 62,272 patients with migraine or NMH. Patients with migraine were categorized into those who received ≥ 1 prescriptions for TE (n = 4959) and those who received NTNE (n = 37,624).
Disclosures: This study received no specific funding. The authors declared no conflicts of interest.
Source: Kim Y et al. Association between migraine and ischemic cardio-cerebrovascular disease (CCVD) and effects of triptans and ergotamine on the risk of ischemic CCVD in patients with migraine in the Korean NHIS-HEALS cohort. Clin Drug Investig. 2023;43(7):541-550 (Jul 17). doi: 10.1007/s40261-023-01290-7
Key clinical point: Migraine increased the risk for ischemic cardio-cerebrovascular diseases (CCVD), but the risk was lower in those treated with triptans or ergotamine (TE).
Major finding: Compared with patients having non-migraine headaches (NMH), the risk for ischemic CCVD was higher in patients with migraine receiving TE (men: adjusted hazard ratio [aHR] 1.18; 95% CI 1.01-1.39; women: aHR 1.22; 95% CI 1.09-1.37) and in those receiving neither triptans nor ergotamine (NTNE; men: aHR 1.39; 95% CI 1.28-1.50; women: aHR 1.53; 95% CI 1.42-1.65). The risk for ischemic CCVD was lower in the TE vs NTNE group (men: aHR 0.86; 95% CI 0.73-0.999; women: aHR 0.80; 95% CI 0.72-0.88).
Study details: This study included 62,272 patients with migraine or NMH. Patients with migraine were categorized into those who received ≥ 1 prescriptions for TE (n = 4959) and those who received NTNE (n = 37,624).
Disclosures: This study received no specific funding. The authors declared no conflicts of interest.
Source: Kim Y et al. Association between migraine and ischemic cardio-cerebrovascular disease (CCVD) and effects of triptans and ergotamine on the risk of ischemic CCVD in patients with migraine in the Korean NHIS-HEALS cohort. Clin Drug Investig. 2023;43(7):541-550 (Jul 17). doi: 10.1007/s40261-023-01290-7
Anti-CGRP mAb equally effective when restarted in patients with migraine
Key clinical point: Retreatment with monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) or its receptor was highly effective with persistent benefits in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed the first treatment year followed by 1-3 months of discontinuation.
Major finding: In the second treatment year, monthly migraine days (MMD) were lower than pre-treatment baseline levels (P < .0001), with only 23.5% presenting with same or higher MMD at the baseline of the second vs first treatment year (P = .207). MMD at 90-112 days after treatment initiation were also lower in the second vs first treatment year (7.2 vs 8.8; P < .001).
Study details: Findings are from a prospective observational cohort study including 226 patients with HFEM and CM who received erenumab (n = 125) and either galcanezumab or fremanezumab (n = 101).
Disclosures: This study was funded by Fondazione Policlinico Campus Bio-Medico, Italy. Some authors declared receiving travel grants, personal fees, research support, or honoraria for participation in advisory boards, speaker panels, or clinical investigation studies from various sources.
Source: Vernieri F et al. Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: The multicenter prospective cohort RE-DO study. J Neurol. 2023 (Jul 19). doi: 10.1007/s00415-023-11872-2
Key clinical point: Retreatment with monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) or its receptor was highly effective with persistent benefits in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed the first treatment year followed by 1-3 months of discontinuation.
Major finding: In the second treatment year, monthly migraine days (MMD) were lower than pre-treatment baseline levels (P < .0001), with only 23.5% presenting with same or higher MMD at the baseline of the second vs first treatment year (P = .207). MMD at 90-112 days after treatment initiation were also lower in the second vs first treatment year (7.2 vs 8.8; P < .001).
Study details: Findings are from a prospective observational cohort study including 226 patients with HFEM and CM who received erenumab (n = 125) and either galcanezumab or fremanezumab (n = 101).
Disclosures: This study was funded by Fondazione Policlinico Campus Bio-Medico, Italy. Some authors declared receiving travel grants, personal fees, research support, or honoraria for participation in advisory boards, speaker panels, or clinical investigation studies from various sources.
Source: Vernieri F et al. Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: The multicenter prospective cohort RE-DO study. J Neurol. 2023 (Jul 19). doi: 10.1007/s00415-023-11872-2
Key clinical point: Retreatment with monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) or its receptor was highly effective with persistent benefits in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed the first treatment year followed by 1-3 months of discontinuation.
Major finding: In the second treatment year, monthly migraine days (MMD) were lower than pre-treatment baseline levels (P < .0001), with only 23.5% presenting with same or higher MMD at the baseline of the second vs first treatment year (P = .207). MMD at 90-112 days after treatment initiation were also lower in the second vs first treatment year (7.2 vs 8.8; P < .001).
Study details: Findings are from a prospective observational cohort study including 226 patients with HFEM and CM who received erenumab (n = 125) and either galcanezumab or fremanezumab (n = 101).
Disclosures: This study was funded by Fondazione Policlinico Campus Bio-Medico, Italy. Some authors declared receiving travel grants, personal fees, research support, or honoraria for participation in advisory boards, speaker panels, or clinical investigation studies from various sources.
Source: Vernieri F et al. Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: The multicenter prospective cohort RE-DO study. J Neurol. 2023 (Jul 19). doi: 10.1007/s00415-023-11872-2