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AI in Medicine: Are Large Language Models Ready for the Exam Room?

Article Type
Changed
Tue, 10/29/2024 - 10:52

In seconds, Ravi Parikh, MD, an oncologist at the Emory University School of Medicine in Atlanta, had a summary of his patient’s entire medical history. Normally, Parikh skimmed the cumbersome files before seeing a patient. However, the artificial intelligence (AI) tool his institution was testing could list the highlights he needed in a fraction of the time.

“On the whole, I like it ... it saves me time,” Parikh said of the tool. “But I’d be lying if I told you it was perfect all the time. It’s interpreting the [patient] history in some ways that may be inaccurate,” he said.

Within the first week of testing the tool, Parikh started to notice that the large language model (LLM) made a particular mistake in his patients with prostate cancer. If their prostate-specific antigen test results came back slightly elevated — which is part of normal variation — the LLM recorded it as disease progression. Because Parikh reviews all his notes — with or without using an AI tool — after a visit, he easily caught the mistake before it was added to the chart. “The problem, I think, is if these mistakes go under the hood,” he said.

In the data science world, these mistakes are called hallucinations. And a growing body of research suggests they’re happening more frequently than is safe for healthcare. The industry promised LLMs would alleviate administrative burden and reduce physician burnout. But so far, studies show these AI-tool mistakes often create more work for doctors, not less. To truly help physicians and be safe for patients, some experts say healthcare needs to build its own LLMs from the ground up. And all agree that the field desperately needs a way to vet these algorithms more thoroughly.
 

Prone to Error

Right now, “I think the industry is focused on taking existing LLMs and forcing them into usage for healthcare,” said Nigam H. Shah, MBBS, PhD, chief data scientist for Stanford Health. However, the value of deploying general LLMs in the healthcare space is questionable. “People are starting to wonder if we’re using these tools wrong,” he told this news organization.

In 2023, Shah and his colleagues evaluated seven LLMs on their ability to answer electronic health record–based questions. For realistic tasks, the error rate in the best cases was about 35%, he said. “To me, that rate seems a bit high ... to adopt for routine use.”

study earlier this year by the UC San Diego School of Medicine showed that using LLMs to respond to patient messages increased the time doctors spent on messages. And this summer, a study by the clinical AI firm Mendel found that when GPT-4o or Llama-3 were used to summarize patient medical records, almost every summary contained at least one type of hallucination.

“We’ve seen cases where a patient does have drug allergies, but the system says ‘no known drug allergies’ ” in the medical history summary, said Wael Salloum, PhD, cofounder and chief science officer at Mendel. “That’s a serious hallucination.” And if physicians have to constantly verify what the system is telling them, that “defeats the purpose [of summarization],” he said.
 

 

 

A Higher Quality Diet

Part of the trouble with LLMs is that there’s just not enough high-quality information to feed them. The algorithms are insatiable, requiring vast swaths of data for training. GPT-3.5, for instance, was trained on 570 GB of data from the internet, more than 300 billion words. And to train GPT-4o, OpenAI reportedly transcribed more than 1 million hours of YouTube content.

However, the strategies that built these general LLMs don’t always translate well to healthcare. The internet is full of low-quality or misleading health information from wellness sites and supplement advertisements. And even data that are trustworthy, like the millions of clinical studies and the US Food and Drug Administration (FDA) statements, can be outdated, Salloum said. And “an LLM in training can’t distinguish good from bad,” he added.

The good news is that clinicians don’t rely on controversial information in the real world. Medical knowledge is standardized. “Healthcare is a domain rich with explicit knowledge,” Salloum said. So there’s potential to build a more reliable LLM that is guided by robust medical standards and guidelines.

It’s possible that healthcare could use small language models, which are LLM’s pocket-sized cousins, and perform tasks needing only bite-sized datasets requiring fewer resources and easier fine-tuning, according to Microsoft’s website. Shah said training these smaller models on real medical data might be an option, like an LLM meant to respond to patient messages that could be trained with real messages sent by physicians.

Several groups are already working on databases of standardized human medical knowledge or real physician responses. “Perhaps that will work better than using LLMs trained on the general internet. Those studies need to be done,” Shah said.

Jon Tamir, assistant professor of electrical and computer engineering and co-lead of the AI Health Lab at The University of Texas at Austin, said, “The community has recognized that we are entering a new era of AI where the dataset itself is the most important aspect. We need training sets that are highly curated and highly specialized.

“If the dataset is highly specialized, it will definitely help reduce hallucinations,” he said.
 

Cutting Overconfidence

A major problem with LLM mistakes is that they are often hard to detect. Hallucinations can be highly convincing even if they’re highly inaccurate, according to Tamir.

When Shah, for instance, was recently testing an LLM on de-identified patient data, he asked the LLM which blood test the patient last had. The model responded with “complete blood count [CBC].” But when he asked for the results, the model gave him white blood count and other values. “Turns out that record did not have a CBC done at all! The result was entirely made up,” he said.

Making healthcare LLMs safer and more reliable will mean training AI to acknowledge potential mistakes and uncertainty. Existing LLMs are trained to project confidence and produce a lot of answers, even when there isn’t one, Salloum said. They rarely respond with “I don’t know” even when their prediction has low confidence, he added.

Healthcare stands to benefit from a system that highlights uncertainty and potential errors. For instance, if a patient’s history shows they have smoked, stopped smoking, vaped, and started smoking again. The LLM might call them a smoker but flag the comment as uncertain because the chronology is complicated, Salloum said.

Tamir added that this strategy could improve LLM and doctor collaboration by honing in on where human expertise is needed most.
 

 

 

Too Little Evaluation

For any improvement strategy to work, LLMs — and all AI-assisted healthcare tools — first need a better evaluation framework. So far, LLMs have “been used in really exciting ways but not really well-vetted ways,” Tamir said.

While some AI-assisted tools, particularly in medical imaging, have undergone rigorous FDA evaluations and earned approval, most haven’t. And because the FDA only regulates algorithms that are considered medical devices, Parikh said that most LLMs used for administrative tasks and efficiency don’t fall under the regulatory agency’s purview.

But these algorithms still have access to patient information and can directly influence patient and doctor decisions. Third-party regulatory agencies are expected to emerge, but it’s still unclear who those will be. Before developers can build a safer and more efficient LLM for healthcare, they’ll need better guidelines and guardrails. “Unless we figure out evaluation, how would we know whether the healthcare-appropriate large language models are better or worse?” Shah asked.
 

A version of this article appeared on Medscape.com.

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In seconds, Ravi Parikh, MD, an oncologist at the Emory University School of Medicine in Atlanta, had a summary of his patient’s entire medical history. Normally, Parikh skimmed the cumbersome files before seeing a patient. However, the artificial intelligence (AI) tool his institution was testing could list the highlights he needed in a fraction of the time.

“On the whole, I like it ... it saves me time,” Parikh said of the tool. “But I’d be lying if I told you it was perfect all the time. It’s interpreting the [patient] history in some ways that may be inaccurate,” he said.

Within the first week of testing the tool, Parikh started to notice that the large language model (LLM) made a particular mistake in his patients with prostate cancer. If their prostate-specific antigen test results came back slightly elevated — which is part of normal variation — the LLM recorded it as disease progression. Because Parikh reviews all his notes — with or without using an AI tool — after a visit, he easily caught the mistake before it was added to the chart. “The problem, I think, is if these mistakes go under the hood,” he said.

In the data science world, these mistakes are called hallucinations. And a growing body of research suggests they’re happening more frequently than is safe for healthcare. The industry promised LLMs would alleviate administrative burden and reduce physician burnout. But so far, studies show these AI-tool mistakes often create more work for doctors, not less. To truly help physicians and be safe for patients, some experts say healthcare needs to build its own LLMs from the ground up. And all agree that the field desperately needs a way to vet these algorithms more thoroughly.
 

Prone to Error

Right now, “I think the industry is focused on taking existing LLMs and forcing them into usage for healthcare,” said Nigam H. Shah, MBBS, PhD, chief data scientist for Stanford Health. However, the value of deploying general LLMs in the healthcare space is questionable. “People are starting to wonder if we’re using these tools wrong,” he told this news organization.

In 2023, Shah and his colleagues evaluated seven LLMs on their ability to answer electronic health record–based questions. For realistic tasks, the error rate in the best cases was about 35%, he said. “To me, that rate seems a bit high ... to adopt for routine use.”

study earlier this year by the UC San Diego School of Medicine showed that using LLMs to respond to patient messages increased the time doctors spent on messages. And this summer, a study by the clinical AI firm Mendel found that when GPT-4o or Llama-3 were used to summarize patient medical records, almost every summary contained at least one type of hallucination.

“We’ve seen cases where a patient does have drug allergies, but the system says ‘no known drug allergies’ ” in the medical history summary, said Wael Salloum, PhD, cofounder and chief science officer at Mendel. “That’s a serious hallucination.” And if physicians have to constantly verify what the system is telling them, that “defeats the purpose [of summarization],” he said.
 

 

 

A Higher Quality Diet

Part of the trouble with LLMs is that there’s just not enough high-quality information to feed them. The algorithms are insatiable, requiring vast swaths of data for training. GPT-3.5, for instance, was trained on 570 GB of data from the internet, more than 300 billion words. And to train GPT-4o, OpenAI reportedly transcribed more than 1 million hours of YouTube content.

However, the strategies that built these general LLMs don’t always translate well to healthcare. The internet is full of low-quality or misleading health information from wellness sites and supplement advertisements. And even data that are trustworthy, like the millions of clinical studies and the US Food and Drug Administration (FDA) statements, can be outdated, Salloum said. And “an LLM in training can’t distinguish good from bad,” he added.

The good news is that clinicians don’t rely on controversial information in the real world. Medical knowledge is standardized. “Healthcare is a domain rich with explicit knowledge,” Salloum said. So there’s potential to build a more reliable LLM that is guided by robust medical standards and guidelines.

It’s possible that healthcare could use small language models, which are LLM’s pocket-sized cousins, and perform tasks needing only bite-sized datasets requiring fewer resources and easier fine-tuning, according to Microsoft’s website. Shah said training these smaller models on real medical data might be an option, like an LLM meant to respond to patient messages that could be trained with real messages sent by physicians.

Several groups are already working on databases of standardized human medical knowledge or real physician responses. “Perhaps that will work better than using LLMs trained on the general internet. Those studies need to be done,” Shah said.

Jon Tamir, assistant professor of electrical and computer engineering and co-lead of the AI Health Lab at The University of Texas at Austin, said, “The community has recognized that we are entering a new era of AI where the dataset itself is the most important aspect. We need training sets that are highly curated and highly specialized.

“If the dataset is highly specialized, it will definitely help reduce hallucinations,” he said.
 

Cutting Overconfidence

A major problem with LLM mistakes is that they are often hard to detect. Hallucinations can be highly convincing even if they’re highly inaccurate, according to Tamir.

When Shah, for instance, was recently testing an LLM on de-identified patient data, he asked the LLM which blood test the patient last had. The model responded with “complete blood count [CBC].” But when he asked for the results, the model gave him white blood count and other values. “Turns out that record did not have a CBC done at all! The result was entirely made up,” he said.

Making healthcare LLMs safer and more reliable will mean training AI to acknowledge potential mistakes and uncertainty. Existing LLMs are trained to project confidence and produce a lot of answers, even when there isn’t one, Salloum said. They rarely respond with “I don’t know” even when their prediction has low confidence, he added.

Healthcare stands to benefit from a system that highlights uncertainty and potential errors. For instance, if a patient’s history shows they have smoked, stopped smoking, vaped, and started smoking again. The LLM might call them a smoker but flag the comment as uncertain because the chronology is complicated, Salloum said.

Tamir added that this strategy could improve LLM and doctor collaboration by honing in on where human expertise is needed most.
 

 

 

Too Little Evaluation

For any improvement strategy to work, LLMs — and all AI-assisted healthcare tools — first need a better evaluation framework. So far, LLMs have “been used in really exciting ways but not really well-vetted ways,” Tamir said.

While some AI-assisted tools, particularly in medical imaging, have undergone rigorous FDA evaluations and earned approval, most haven’t. And because the FDA only regulates algorithms that are considered medical devices, Parikh said that most LLMs used for administrative tasks and efficiency don’t fall under the regulatory agency’s purview.

But these algorithms still have access to patient information and can directly influence patient and doctor decisions. Third-party regulatory agencies are expected to emerge, but it’s still unclear who those will be. Before developers can build a safer and more efficient LLM for healthcare, they’ll need better guidelines and guardrails. “Unless we figure out evaluation, how would we know whether the healthcare-appropriate large language models are better or worse?” Shah asked.
 

A version of this article appeared on Medscape.com.

In seconds, Ravi Parikh, MD, an oncologist at the Emory University School of Medicine in Atlanta, had a summary of his patient’s entire medical history. Normally, Parikh skimmed the cumbersome files before seeing a patient. However, the artificial intelligence (AI) tool his institution was testing could list the highlights he needed in a fraction of the time.

“On the whole, I like it ... it saves me time,” Parikh said of the tool. “But I’d be lying if I told you it was perfect all the time. It’s interpreting the [patient] history in some ways that may be inaccurate,” he said.

Within the first week of testing the tool, Parikh started to notice that the large language model (LLM) made a particular mistake in his patients with prostate cancer. If their prostate-specific antigen test results came back slightly elevated — which is part of normal variation — the LLM recorded it as disease progression. Because Parikh reviews all his notes — with or without using an AI tool — after a visit, he easily caught the mistake before it was added to the chart. “The problem, I think, is if these mistakes go under the hood,” he said.

In the data science world, these mistakes are called hallucinations. And a growing body of research suggests they’re happening more frequently than is safe for healthcare. The industry promised LLMs would alleviate administrative burden and reduce physician burnout. But so far, studies show these AI-tool mistakes often create more work for doctors, not less. To truly help physicians and be safe for patients, some experts say healthcare needs to build its own LLMs from the ground up. And all agree that the field desperately needs a way to vet these algorithms more thoroughly.
 

Prone to Error

Right now, “I think the industry is focused on taking existing LLMs and forcing them into usage for healthcare,” said Nigam H. Shah, MBBS, PhD, chief data scientist for Stanford Health. However, the value of deploying general LLMs in the healthcare space is questionable. “People are starting to wonder if we’re using these tools wrong,” he told this news organization.

In 2023, Shah and his colleagues evaluated seven LLMs on their ability to answer electronic health record–based questions. For realistic tasks, the error rate in the best cases was about 35%, he said. “To me, that rate seems a bit high ... to adopt for routine use.”

study earlier this year by the UC San Diego School of Medicine showed that using LLMs to respond to patient messages increased the time doctors spent on messages. And this summer, a study by the clinical AI firm Mendel found that when GPT-4o or Llama-3 were used to summarize patient medical records, almost every summary contained at least one type of hallucination.

“We’ve seen cases where a patient does have drug allergies, but the system says ‘no known drug allergies’ ” in the medical history summary, said Wael Salloum, PhD, cofounder and chief science officer at Mendel. “That’s a serious hallucination.” And if physicians have to constantly verify what the system is telling them, that “defeats the purpose [of summarization],” he said.
 

 

 

A Higher Quality Diet

Part of the trouble with LLMs is that there’s just not enough high-quality information to feed them. The algorithms are insatiable, requiring vast swaths of data for training. GPT-3.5, for instance, was trained on 570 GB of data from the internet, more than 300 billion words. And to train GPT-4o, OpenAI reportedly transcribed more than 1 million hours of YouTube content.

However, the strategies that built these general LLMs don’t always translate well to healthcare. The internet is full of low-quality or misleading health information from wellness sites and supplement advertisements. And even data that are trustworthy, like the millions of clinical studies and the US Food and Drug Administration (FDA) statements, can be outdated, Salloum said. And “an LLM in training can’t distinguish good from bad,” he added.

The good news is that clinicians don’t rely on controversial information in the real world. Medical knowledge is standardized. “Healthcare is a domain rich with explicit knowledge,” Salloum said. So there’s potential to build a more reliable LLM that is guided by robust medical standards and guidelines.

It’s possible that healthcare could use small language models, which are LLM’s pocket-sized cousins, and perform tasks needing only bite-sized datasets requiring fewer resources and easier fine-tuning, according to Microsoft’s website. Shah said training these smaller models on real medical data might be an option, like an LLM meant to respond to patient messages that could be trained with real messages sent by physicians.

Several groups are already working on databases of standardized human medical knowledge or real physician responses. “Perhaps that will work better than using LLMs trained on the general internet. Those studies need to be done,” Shah said.

Jon Tamir, assistant professor of electrical and computer engineering and co-lead of the AI Health Lab at The University of Texas at Austin, said, “The community has recognized that we are entering a new era of AI where the dataset itself is the most important aspect. We need training sets that are highly curated and highly specialized.

“If the dataset is highly specialized, it will definitely help reduce hallucinations,” he said.
 

Cutting Overconfidence

A major problem with LLM mistakes is that they are often hard to detect. Hallucinations can be highly convincing even if they’re highly inaccurate, according to Tamir.

When Shah, for instance, was recently testing an LLM on de-identified patient data, he asked the LLM which blood test the patient last had. The model responded with “complete blood count [CBC].” But when he asked for the results, the model gave him white blood count and other values. “Turns out that record did not have a CBC done at all! The result was entirely made up,” he said.

Making healthcare LLMs safer and more reliable will mean training AI to acknowledge potential mistakes and uncertainty. Existing LLMs are trained to project confidence and produce a lot of answers, even when there isn’t one, Salloum said. They rarely respond with “I don’t know” even when their prediction has low confidence, he added.

Healthcare stands to benefit from a system that highlights uncertainty and potential errors. For instance, if a patient’s history shows they have smoked, stopped smoking, vaped, and started smoking again. The LLM might call them a smoker but flag the comment as uncertain because the chronology is complicated, Salloum said.

Tamir added that this strategy could improve LLM and doctor collaboration by honing in on where human expertise is needed most.
 

 

 

Too Little Evaluation

For any improvement strategy to work, LLMs — and all AI-assisted healthcare tools — first need a better evaluation framework. So far, LLMs have “been used in really exciting ways but not really well-vetted ways,” Tamir said.

While some AI-assisted tools, particularly in medical imaging, have undergone rigorous FDA evaluations and earned approval, most haven’t. And because the FDA only regulates algorithms that are considered medical devices, Parikh said that most LLMs used for administrative tasks and efficiency don’t fall under the regulatory agency’s purview.

But these algorithms still have access to patient information and can directly influence patient and doctor decisions. Third-party regulatory agencies are expected to emerge, but it’s still unclear who those will be. Before developers can build a safer and more efficient LLM for healthcare, they’ll need better guidelines and guardrails. “Unless we figure out evaluation, how would we know whether the healthcare-appropriate large language models are better or worse?” Shah asked.
 

A version of this article appeared on Medscape.com.

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Family Medicine–Led Obstetric Units Achieve Lower C-Section Rates, Better Safety Culture

Article Type
Changed
Tue, 10/29/2024 - 10:11

Labor and delivery centers run by family medicine (FM) healthcare providers have a lower cesarean delivery rate and better safety culture than centers led by obstetricians (OBs), based on observational data from Iowa hospitals.

These findings show how FM providers backed up by general surgeons can deliver a high standard of obstetric care, suggesting that this team-based model could address growing maternity care deserts across the United States, lead author Emily White VanGompel, MD, of the University of Illinois College of Medicine in Chicago, and colleagues reported.

“Despite decades of research documenting the high quality of care provided by FM physicians, controversy continues regarding whether family physicians trained in existing FM residency programs should provide intrapartum obstetric care,” the investigators wrote in Annals of Family Medicine.

This controversy, though long-standing, has gained more attention in the past decade with worsening severe maternal morbidity and maternal health disparities in rural areas, along with state-based perinatal quality initiatives to improve care and reduce severe maternal morbidity. These efforts have largely involved obstetric, nursing, and midwifery organizations, with minimal input from FM professionals.

The role of FM in these initiatives therefore remains unexplored.

This is a clear blind spot, according to White VanGompel and colleagues, who noted that 40% of counties in the United States do not have an OB or a midwife, while only 6.5% of counties lack an FM physician. In other words, FM providers may be the most rational — and widely available — specialty to close gaps in obstetric care.
 

Study Reveals Fewer C-Sections, Better Safety Culture Among FM-Led Centers

To explore the viability of an FM-led model, the investigators used a cross-sectional survey to assess the relationship between staffing models and perinatal outcomes. A total of 849 clinicians, including physicians, nurses, and midwives from 39 hospitals, were surveyed as part of a statewide quality improvement initiative designed to reduce cesarean delivery rates. The hospitals were categorized on the basis of the type of physician providing intrapartum care: Some hospitals were staffed exclusively by FM physicians (13), some by OBs only (11), and others by both types of providers (15).

The primary outcome measured was the low-risk cesarean delivery rate, specifically the nulliparous, term, singleton, vertex cesarean delivery rate.

The study found that FM-only hospitals, all of which were located in rural areas with fewer than 1000 annual births, had significantly lower cesarean delivery rates than hospitals with mixed or OB-only staffing. After adjusting for factors such as hospital birth volume, geographic location, patient body mass index, maternal age, and insurance status, FM-only hospitals had an adjusted 34.3% lower rate of cesarean sections than hospitals with both FM and OB physicians (adjusted incidence rate ratio, 0.66; 95% CI, 0.52-0.98).

In addition to lower cesarean delivery rates, the study revealed that hospitals staffed exclusively by FM physicians reported a stronger safety culture, as measured by nurse perceptions of unit norms supporting vaginal birth. Nurses at FM-only hospitals were more likely to endorse safety practices that favored vaginal delivery, a finding that was statistically significant. The study also found that nurses at FM-only hospitals rated overall unit safety culture higher than those at hospitals staffed solely by OBs or a combination of FM physicians and OBs.

“I’m not surprised [by these findings],” said Joedrecka S. Brown Speights, MD, professor and chair of the Department of Family Medicine and Rural Health at Florida State University College of Medicine, Tallahassee.

She noted that the data echo previous reports demonstrating the broader benefits of FM involvement.

“When people get primary care, life is better,” Brown Speights said, citing improved outcomes, greater health equity, and lower overall healthcare costs associated with high-quality primary care.

“That’s what we need for women and for pregnant persons, especially in rural areas,” she said.
 

 

 

The Model Itself Could Be the Biggest Finding

According to White VanGompel, the biggest finding from the study is the existence of the team-based model itself — where FM providers lead obstetric care with support from general surgeons.

“Quite honestly, many people around the country, including family physicians like myself, did not know [this model] existed and was thriving in these rural areas that are on the verge of becoming maternity care deserts,” White VanGompel said in an interview. “That makes a huge difference clinically because those are patients that otherwise wouldn’t have access to comprehensive pregnancy care.”

This FM-led model has the added advantage of improving continuity of care, she added, noting that issues like maternal mental health — a major contributor to postpartum morbidity and mortality — are a primary care issue.

“If we are not involved in that patient’s pregnancy care, and we don’t know that they’ve had this postpartum course or they’ve had antepartum depression, it’s very hard for us to then jump in and accurately treat that person,” White VanGompel said. “If we’re involved in the entire course of care, we can make that contribution.”

Emilio A. Russo, MD, Marie Lahasky Professor of Family Medicine and chair of the Department of Family Medicine at Louisiana State University (LSU) Health Sciences Center New Orleans, and program director of the LSU Rural Family Medicine Program, Bogalusa, Louisiana, agreed that FM providers’ more continuous care, along with experience treating both mothers and babies, make them invaluable in the maternity care setting.

“We are missing the opportunity to incorporate family physicians and nurse midwives into the continuum of care for women, especially in these remote areas,” Russo said in an interview. “Family physicians and nurse midwives are the only two [groups] in the health system trained and licensed to care for both mother and baby, and I have to believe that there’s something profoundly important about that.”
 

Barriers May Block FM Providers From Obstetric Practice

In a recent Birth editorial, Simone Hampton, MD, of Carle Health Family Medicine, Urbana, Illinois, explored a key question: Why aren’t we using FM to help confront the maternal mortality crisis in the United States?

Hampton described how obstetric care is often siloed between specialties and barriers, including insufficient training, organizational constraints, and malpractice coverage, deter FM physicians from practicing obstetrics.

In an additional written comment, Hampton suggested that family doctors also face misconceptions about their ability to provide obstetric care, even with rigorous training and a comprehensive skill set.

“We are interested in caring for families,” Hampton said, emphasizing how FM providers are uniquely trained to care for the maternal dyad in a way that OBs are not and often view birth as a more natural process that typically does not require intervention.

Unfortunately, hospital administrators often maintain a different view, Brown Speights said, describing how some centers limit obstetric care privileges exclusively to OBs or require case volume minimums that can be tough to reach in a rural setting.

“If you have low-volume places, you can have a challenge meeting the numbers to keep up the requirements to get credentialed to practice obstetrics at the hospital,” she said, which only exacerbates gaps in maternity care access.

“This type of skill set in a rural place often, by default, represents a lower volume,” Russo said. “So how do the interests of competency and access intersect in this space?”

Generating more data to support the quality of FM-led obstetric models could be the clearest path forward, according to White VanGompel. She suggested that team-based approaches like the one described in the present study deserve further investigation in other hospital systems.

Until then, this gap in maternity care remains an ongoing, and often personal, concern.

“The more I do this quality work, the more I’m in these rooms where I’m the only family physician and I’m surrounded by all of these amazing labor and delivery nurses and obstetricians and maternal-fetal medicine doctors and midwives and doulas,” White VanGompel said. “I’m just constantly asking myself, Why am I the only family doctor in the room?”

This study was supported by the Agency for Healthcare Research and Quality and the North Shore Auxiliary. The Iowa Maternal Quality Care Collaborative is supported by a State Maternal Health Innovation award from the Health Resources and Services Administration. The investigators, Hampton and Brown Speights, disclosed no conflicts of interest.

A version of this article first appeared on Medscape.com.

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Labor and delivery centers run by family medicine (FM) healthcare providers have a lower cesarean delivery rate and better safety culture than centers led by obstetricians (OBs), based on observational data from Iowa hospitals.

These findings show how FM providers backed up by general surgeons can deliver a high standard of obstetric care, suggesting that this team-based model could address growing maternity care deserts across the United States, lead author Emily White VanGompel, MD, of the University of Illinois College of Medicine in Chicago, and colleagues reported.

“Despite decades of research documenting the high quality of care provided by FM physicians, controversy continues regarding whether family physicians trained in existing FM residency programs should provide intrapartum obstetric care,” the investigators wrote in Annals of Family Medicine.

This controversy, though long-standing, has gained more attention in the past decade with worsening severe maternal morbidity and maternal health disparities in rural areas, along with state-based perinatal quality initiatives to improve care and reduce severe maternal morbidity. These efforts have largely involved obstetric, nursing, and midwifery organizations, with minimal input from FM professionals.

The role of FM in these initiatives therefore remains unexplored.

This is a clear blind spot, according to White VanGompel and colleagues, who noted that 40% of counties in the United States do not have an OB or a midwife, while only 6.5% of counties lack an FM physician. In other words, FM providers may be the most rational — and widely available — specialty to close gaps in obstetric care.
 

Study Reveals Fewer C-Sections, Better Safety Culture Among FM-Led Centers

To explore the viability of an FM-led model, the investigators used a cross-sectional survey to assess the relationship between staffing models and perinatal outcomes. A total of 849 clinicians, including physicians, nurses, and midwives from 39 hospitals, were surveyed as part of a statewide quality improvement initiative designed to reduce cesarean delivery rates. The hospitals were categorized on the basis of the type of physician providing intrapartum care: Some hospitals were staffed exclusively by FM physicians (13), some by OBs only (11), and others by both types of providers (15).

The primary outcome measured was the low-risk cesarean delivery rate, specifically the nulliparous, term, singleton, vertex cesarean delivery rate.

The study found that FM-only hospitals, all of which were located in rural areas with fewer than 1000 annual births, had significantly lower cesarean delivery rates than hospitals with mixed or OB-only staffing. After adjusting for factors such as hospital birth volume, geographic location, patient body mass index, maternal age, and insurance status, FM-only hospitals had an adjusted 34.3% lower rate of cesarean sections than hospitals with both FM and OB physicians (adjusted incidence rate ratio, 0.66; 95% CI, 0.52-0.98).

In addition to lower cesarean delivery rates, the study revealed that hospitals staffed exclusively by FM physicians reported a stronger safety culture, as measured by nurse perceptions of unit norms supporting vaginal birth. Nurses at FM-only hospitals were more likely to endorse safety practices that favored vaginal delivery, a finding that was statistically significant. The study also found that nurses at FM-only hospitals rated overall unit safety culture higher than those at hospitals staffed solely by OBs or a combination of FM physicians and OBs.

“I’m not surprised [by these findings],” said Joedrecka S. Brown Speights, MD, professor and chair of the Department of Family Medicine and Rural Health at Florida State University College of Medicine, Tallahassee.

She noted that the data echo previous reports demonstrating the broader benefits of FM involvement.

“When people get primary care, life is better,” Brown Speights said, citing improved outcomes, greater health equity, and lower overall healthcare costs associated with high-quality primary care.

“That’s what we need for women and for pregnant persons, especially in rural areas,” she said.
 

 

 

The Model Itself Could Be the Biggest Finding

According to White VanGompel, the biggest finding from the study is the existence of the team-based model itself — where FM providers lead obstetric care with support from general surgeons.

“Quite honestly, many people around the country, including family physicians like myself, did not know [this model] existed and was thriving in these rural areas that are on the verge of becoming maternity care deserts,” White VanGompel said in an interview. “That makes a huge difference clinically because those are patients that otherwise wouldn’t have access to comprehensive pregnancy care.”

This FM-led model has the added advantage of improving continuity of care, she added, noting that issues like maternal mental health — a major contributor to postpartum morbidity and mortality — are a primary care issue.

“If we are not involved in that patient’s pregnancy care, and we don’t know that they’ve had this postpartum course or they’ve had antepartum depression, it’s very hard for us to then jump in and accurately treat that person,” White VanGompel said. “If we’re involved in the entire course of care, we can make that contribution.”

Emilio A. Russo, MD, Marie Lahasky Professor of Family Medicine and chair of the Department of Family Medicine at Louisiana State University (LSU) Health Sciences Center New Orleans, and program director of the LSU Rural Family Medicine Program, Bogalusa, Louisiana, agreed that FM providers’ more continuous care, along with experience treating both mothers and babies, make them invaluable in the maternity care setting.

“We are missing the opportunity to incorporate family physicians and nurse midwives into the continuum of care for women, especially in these remote areas,” Russo said in an interview. “Family physicians and nurse midwives are the only two [groups] in the health system trained and licensed to care for both mother and baby, and I have to believe that there’s something profoundly important about that.”
 

Barriers May Block FM Providers From Obstetric Practice

In a recent Birth editorial, Simone Hampton, MD, of Carle Health Family Medicine, Urbana, Illinois, explored a key question: Why aren’t we using FM to help confront the maternal mortality crisis in the United States?

Hampton described how obstetric care is often siloed between specialties and barriers, including insufficient training, organizational constraints, and malpractice coverage, deter FM physicians from practicing obstetrics.

In an additional written comment, Hampton suggested that family doctors also face misconceptions about their ability to provide obstetric care, even with rigorous training and a comprehensive skill set.

“We are interested in caring for families,” Hampton said, emphasizing how FM providers are uniquely trained to care for the maternal dyad in a way that OBs are not and often view birth as a more natural process that typically does not require intervention.

Unfortunately, hospital administrators often maintain a different view, Brown Speights said, describing how some centers limit obstetric care privileges exclusively to OBs or require case volume minimums that can be tough to reach in a rural setting.

“If you have low-volume places, you can have a challenge meeting the numbers to keep up the requirements to get credentialed to practice obstetrics at the hospital,” she said, which only exacerbates gaps in maternity care access.

“This type of skill set in a rural place often, by default, represents a lower volume,” Russo said. “So how do the interests of competency and access intersect in this space?”

Generating more data to support the quality of FM-led obstetric models could be the clearest path forward, according to White VanGompel. She suggested that team-based approaches like the one described in the present study deserve further investigation in other hospital systems.

Until then, this gap in maternity care remains an ongoing, and often personal, concern.

“The more I do this quality work, the more I’m in these rooms where I’m the only family physician and I’m surrounded by all of these amazing labor and delivery nurses and obstetricians and maternal-fetal medicine doctors and midwives and doulas,” White VanGompel said. “I’m just constantly asking myself, Why am I the only family doctor in the room?”

This study was supported by the Agency for Healthcare Research and Quality and the North Shore Auxiliary. The Iowa Maternal Quality Care Collaborative is supported by a State Maternal Health Innovation award from the Health Resources and Services Administration. The investigators, Hampton and Brown Speights, disclosed no conflicts of interest.

A version of this article first appeared on Medscape.com.

Labor and delivery centers run by family medicine (FM) healthcare providers have a lower cesarean delivery rate and better safety culture than centers led by obstetricians (OBs), based on observational data from Iowa hospitals.

These findings show how FM providers backed up by general surgeons can deliver a high standard of obstetric care, suggesting that this team-based model could address growing maternity care deserts across the United States, lead author Emily White VanGompel, MD, of the University of Illinois College of Medicine in Chicago, and colleagues reported.

“Despite decades of research documenting the high quality of care provided by FM physicians, controversy continues regarding whether family physicians trained in existing FM residency programs should provide intrapartum obstetric care,” the investigators wrote in Annals of Family Medicine.

This controversy, though long-standing, has gained more attention in the past decade with worsening severe maternal morbidity and maternal health disparities in rural areas, along with state-based perinatal quality initiatives to improve care and reduce severe maternal morbidity. These efforts have largely involved obstetric, nursing, and midwifery organizations, with minimal input from FM professionals.

The role of FM in these initiatives therefore remains unexplored.

This is a clear blind spot, according to White VanGompel and colleagues, who noted that 40% of counties in the United States do not have an OB or a midwife, while only 6.5% of counties lack an FM physician. In other words, FM providers may be the most rational — and widely available — specialty to close gaps in obstetric care.
 

Study Reveals Fewer C-Sections, Better Safety Culture Among FM-Led Centers

To explore the viability of an FM-led model, the investigators used a cross-sectional survey to assess the relationship between staffing models and perinatal outcomes. A total of 849 clinicians, including physicians, nurses, and midwives from 39 hospitals, were surveyed as part of a statewide quality improvement initiative designed to reduce cesarean delivery rates. The hospitals were categorized on the basis of the type of physician providing intrapartum care: Some hospitals were staffed exclusively by FM physicians (13), some by OBs only (11), and others by both types of providers (15).

The primary outcome measured was the low-risk cesarean delivery rate, specifically the nulliparous, term, singleton, vertex cesarean delivery rate.

The study found that FM-only hospitals, all of which were located in rural areas with fewer than 1000 annual births, had significantly lower cesarean delivery rates than hospitals with mixed or OB-only staffing. After adjusting for factors such as hospital birth volume, geographic location, patient body mass index, maternal age, and insurance status, FM-only hospitals had an adjusted 34.3% lower rate of cesarean sections than hospitals with both FM and OB physicians (adjusted incidence rate ratio, 0.66; 95% CI, 0.52-0.98).

In addition to lower cesarean delivery rates, the study revealed that hospitals staffed exclusively by FM physicians reported a stronger safety culture, as measured by nurse perceptions of unit norms supporting vaginal birth. Nurses at FM-only hospitals were more likely to endorse safety practices that favored vaginal delivery, a finding that was statistically significant. The study also found that nurses at FM-only hospitals rated overall unit safety culture higher than those at hospitals staffed solely by OBs or a combination of FM physicians and OBs.

“I’m not surprised [by these findings],” said Joedrecka S. Brown Speights, MD, professor and chair of the Department of Family Medicine and Rural Health at Florida State University College of Medicine, Tallahassee.

She noted that the data echo previous reports demonstrating the broader benefits of FM involvement.

“When people get primary care, life is better,” Brown Speights said, citing improved outcomes, greater health equity, and lower overall healthcare costs associated with high-quality primary care.

“That’s what we need for women and for pregnant persons, especially in rural areas,” she said.
 

 

 

The Model Itself Could Be the Biggest Finding

According to White VanGompel, the biggest finding from the study is the existence of the team-based model itself — where FM providers lead obstetric care with support from general surgeons.

“Quite honestly, many people around the country, including family physicians like myself, did not know [this model] existed and was thriving in these rural areas that are on the verge of becoming maternity care deserts,” White VanGompel said in an interview. “That makes a huge difference clinically because those are patients that otherwise wouldn’t have access to comprehensive pregnancy care.”

This FM-led model has the added advantage of improving continuity of care, she added, noting that issues like maternal mental health — a major contributor to postpartum morbidity and mortality — are a primary care issue.

“If we are not involved in that patient’s pregnancy care, and we don’t know that they’ve had this postpartum course or they’ve had antepartum depression, it’s very hard for us to then jump in and accurately treat that person,” White VanGompel said. “If we’re involved in the entire course of care, we can make that contribution.”

Emilio A. Russo, MD, Marie Lahasky Professor of Family Medicine and chair of the Department of Family Medicine at Louisiana State University (LSU) Health Sciences Center New Orleans, and program director of the LSU Rural Family Medicine Program, Bogalusa, Louisiana, agreed that FM providers’ more continuous care, along with experience treating both mothers and babies, make them invaluable in the maternity care setting.

“We are missing the opportunity to incorporate family physicians and nurse midwives into the continuum of care for women, especially in these remote areas,” Russo said in an interview. “Family physicians and nurse midwives are the only two [groups] in the health system trained and licensed to care for both mother and baby, and I have to believe that there’s something profoundly important about that.”
 

Barriers May Block FM Providers From Obstetric Practice

In a recent Birth editorial, Simone Hampton, MD, of Carle Health Family Medicine, Urbana, Illinois, explored a key question: Why aren’t we using FM to help confront the maternal mortality crisis in the United States?

Hampton described how obstetric care is often siloed between specialties and barriers, including insufficient training, organizational constraints, and malpractice coverage, deter FM physicians from practicing obstetrics.

In an additional written comment, Hampton suggested that family doctors also face misconceptions about their ability to provide obstetric care, even with rigorous training and a comprehensive skill set.

“We are interested in caring for families,” Hampton said, emphasizing how FM providers are uniquely trained to care for the maternal dyad in a way that OBs are not and often view birth as a more natural process that typically does not require intervention.

Unfortunately, hospital administrators often maintain a different view, Brown Speights said, describing how some centers limit obstetric care privileges exclusively to OBs or require case volume minimums that can be tough to reach in a rural setting.

“If you have low-volume places, you can have a challenge meeting the numbers to keep up the requirements to get credentialed to practice obstetrics at the hospital,” she said, which only exacerbates gaps in maternity care access.

“This type of skill set in a rural place often, by default, represents a lower volume,” Russo said. “So how do the interests of competency and access intersect in this space?”

Generating more data to support the quality of FM-led obstetric models could be the clearest path forward, according to White VanGompel. She suggested that team-based approaches like the one described in the present study deserve further investigation in other hospital systems.

Until then, this gap in maternity care remains an ongoing, and often personal, concern.

“The more I do this quality work, the more I’m in these rooms where I’m the only family physician and I’m surrounded by all of these amazing labor and delivery nurses and obstetricians and maternal-fetal medicine doctors and midwives and doulas,” White VanGompel said. “I’m just constantly asking myself, Why am I the only family doctor in the room?”

This study was supported by the Agency for Healthcare Research and Quality and the North Shore Auxiliary. The Iowa Maternal Quality Care Collaborative is supported by a State Maternal Health Innovation award from the Health Resources and Services Administration. The investigators, Hampton and Brown Speights, disclosed no conflicts of interest.

A version of this article first appeared on Medscape.com.

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Cybersecurity Concerns Continue to Rise With Ransom, Data Manipulation, AI Risks

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Tue, 10/29/2024 - 10:00

From the largest healthcare companies to solo practices, just every organization in medicine faces a risk for costly cyberattacks. In recent years, hackers have threatened to release the personal information of patients and employees — or paralyze online systems — unless they’re paid a ransom.

Should companies pay? It’s not an easy answer, a pair of experts told colleagues in an American Medical Association (AMA) cybersecurity webinar on October 18. It turns out that each choice — pay or don’t pay — can end up being costly.

This is just one of the new challenges facing the American medical system on the cybersecurity front, the speakers said. Others include the possibility that hackers will manipulate patient data — turning a medical test negative, for example, when it’s actually positive — and take advantage of the powers of artificial intelligence (AI).

The AMA held the webinar to educate physicians about cybersecurity risks and defenses, an especially hot topic in the wake of February’s Change Healthcare hack, which cost UnitedHealth Group an estimated $2.5 billion — so far — and deeply disrupted the American healthcare system.

Cautionary tales abound. Greg Garcia, executive director for cybersecurity of the Health Sector Coordinating Council, a coalition of medical industry organizations, pointed to a Pennsylvania clinic that refused to pay a ransom to prevent the release of hundreds of images of patients with breast cancer undressed from the waist up. Garcia told webinar participants that the ransom was $5 million.
 

Risky Choices

While the Federal Bureau of Investigation recommends against paying a ransom, this can be a risky choice, Garcia said. Hackers released the images, and the center has reportedly agreed to settle a class-action lawsuit for $65 million. “They traded $5 million for $60 million,” Garcia added, slightly misstating the settlement amount.

Health systems have been cagey about whether they’ve paid ransoms to prevent private data from being made public in cyberattacks. If a ransom is demanded, “it’s every organization for itself,” Garcia said.

He highlighted the case of a chain of psychiatry practices in Finland that suffered a ransomware attack in 2020. The hackers “contacted the patients and said: ‘Hey, call your clinic and tell them to pay the ransom. Otherwise, we’re going to release all your psychiatric notes to the public.’ ”

Cyberattacks continue. In October, Boston Children’s Health Physicians announced that it had suffered a “ recent security incident” involving data — possibly including Social Security numbers and treatment information — regarding patients and employees. A hacker group reportedly claimed responsibility and wants the system, which boasts more than 300 clinicians, to pay a ransom or else it will release the stolen information.
 

Should Paying Ransom Be a Crime?

Christian Dameff, MD, MS, an emergency medicine physician and director of the Center for Healthcare Cybersecurity at the University of California (UC), San Diego, noted that there are efforts to turn paying ransom into a crime. “If people aren’t paying ransoms, then ransomware operators will move to something else that makes them money.”

Dameff urged colleagues to understand we no longer live in a world where clinicians only bother to think of technology when they call the IT department to help them reset their password.

New challenges face clinicians, he said. “How do we develop better strategies, downtime procedures, and safe clinical care in an era where our vital technology may be gone, not just for an hour or 2, but as is the case with these ransomware attacks, sometimes weeks to months.”

Garcia said “cybersecurity is everybody’s responsibility, including frontline clinicians. Because you’re touching data, you’re touching technology, you’re touching patients, and all of those things combine to present some vulnerabilities in the digital world.”
 

 

 

Next Frontier: Hackers May Manipulate Patient Data

Dameff said future hackers may use AI to manipulate individual patient data in ways that threaten patient health. AI makes this easier to accomplish.

“What if I delete your allergies in your electronic health record, or I manipulate your chest x-ray, or I change your lab values so it looks like you’re in diabetic ketoacidosis when you’re not so a clinician gives you insulin when you don’t need it?”

Garcia highlighted another new threat: Phishing efforts that are harder to ignore thanks to AI.

“One of the most successful way that hackers get in, disrupt systems, and steal data is through email phishing, and it’s only going to get better because of artificial intelligence,” he said. “No longer are you going to have typos in that email written by a hacking group in Nigeria or in China. It’s going to be perfect looking.”

What can practices and healthcare systems do? Garcia highlighted federal health agency efforts to encourage organizations to adopt best practices in cybersecurity.

“If you’ve got a data breach, and you can show to the US Department of Health & Human Services [HHS] you have implemented generally recognized cybersecurity controls over the past year, that you have done your best, you did the right thing, and you still got hit, HHS is directed to essentially take it easy on you,” he said. “That’s a positive incentive.”
 

Ransomware Guide in the Works

Dameff said UC San Diego’s Center for Healthcare Cybersecurity plans to publish a free cybersecurity guide in 2025 that will include specific information about ransomware attacks for medical specialties such as cardiology, trauma surgery, and pediatrics.

“Then, should you ever be ransomed, you can pull out this guide. You’ll know what’s going to kind of happen, and you can better prepare for those effects.”

Will the future president prioritize healthcare cybersecurity? That remains to be seen, but crises do have the capacity to concentrate the mind, experts said.

The nation’s capital “has a very short memory, a short attention span. The policymakers tend to be reactive,” Dameff said. “All it takes is yet another Change Healthcare–like attack that disrupts 30% or more of the nation’s healthcare system for the policymakers to sit up, take notice, and try to come up with solutions.”

In addition, he said, an estimated two data breaches/ransomware attacks are occurring per day. “The fact is that we’re all patients, up to the President of the United States and every member of the Congress is a patient.”

There’s a “very existential, very palpable understanding that cyber safety is patient safety and cyber insecurity is patient insecurity,” Dameff said.

A version of this article appeared on Medscape.com.

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From the largest healthcare companies to solo practices, just every organization in medicine faces a risk for costly cyberattacks. In recent years, hackers have threatened to release the personal information of patients and employees — or paralyze online systems — unless they’re paid a ransom.

Should companies pay? It’s not an easy answer, a pair of experts told colleagues in an American Medical Association (AMA) cybersecurity webinar on October 18. It turns out that each choice — pay or don’t pay — can end up being costly.

This is just one of the new challenges facing the American medical system on the cybersecurity front, the speakers said. Others include the possibility that hackers will manipulate patient data — turning a medical test negative, for example, when it’s actually positive — and take advantage of the powers of artificial intelligence (AI).

The AMA held the webinar to educate physicians about cybersecurity risks and defenses, an especially hot topic in the wake of February’s Change Healthcare hack, which cost UnitedHealth Group an estimated $2.5 billion — so far — and deeply disrupted the American healthcare system.

Cautionary tales abound. Greg Garcia, executive director for cybersecurity of the Health Sector Coordinating Council, a coalition of medical industry organizations, pointed to a Pennsylvania clinic that refused to pay a ransom to prevent the release of hundreds of images of patients with breast cancer undressed from the waist up. Garcia told webinar participants that the ransom was $5 million.
 

Risky Choices

While the Federal Bureau of Investigation recommends against paying a ransom, this can be a risky choice, Garcia said. Hackers released the images, and the center has reportedly agreed to settle a class-action lawsuit for $65 million. “They traded $5 million for $60 million,” Garcia added, slightly misstating the settlement amount.

Health systems have been cagey about whether they’ve paid ransoms to prevent private data from being made public in cyberattacks. If a ransom is demanded, “it’s every organization for itself,” Garcia said.

He highlighted the case of a chain of psychiatry practices in Finland that suffered a ransomware attack in 2020. The hackers “contacted the patients and said: ‘Hey, call your clinic and tell them to pay the ransom. Otherwise, we’re going to release all your psychiatric notes to the public.’ ”

Cyberattacks continue. In October, Boston Children’s Health Physicians announced that it had suffered a “ recent security incident” involving data — possibly including Social Security numbers and treatment information — regarding patients and employees. A hacker group reportedly claimed responsibility and wants the system, which boasts more than 300 clinicians, to pay a ransom or else it will release the stolen information.
 

Should Paying Ransom Be a Crime?

Christian Dameff, MD, MS, an emergency medicine physician and director of the Center for Healthcare Cybersecurity at the University of California (UC), San Diego, noted that there are efforts to turn paying ransom into a crime. “If people aren’t paying ransoms, then ransomware operators will move to something else that makes them money.”

Dameff urged colleagues to understand we no longer live in a world where clinicians only bother to think of technology when they call the IT department to help them reset their password.

New challenges face clinicians, he said. “How do we develop better strategies, downtime procedures, and safe clinical care in an era where our vital technology may be gone, not just for an hour or 2, but as is the case with these ransomware attacks, sometimes weeks to months.”

Garcia said “cybersecurity is everybody’s responsibility, including frontline clinicians. Because you’re touching data, you’re touching technology, you’re touching patients, and all of those things combine to present some vulnerabilities in the digital world.”
 

 

 

Next Frontier: Hackers May Manipulate Patient Data

Dameff said future hackers may use AI to manipulate individual patient data in ways that threaten patient health. AI makes this easier to accomplish.

“What if I delete your allergies in your electronic health record, or I manipulate your chest x-ray, or I change your lab values so it looks like you’re in diabetic ketoacidosis when you’re not so a clinician gives you insulin when you don’t need it?”

Garcia highlighted another new threat: Phishing efforts that are harder to ignore thanks to AI.

“One of the most successful way that hackers get in, disrupt systems, and steal data is through email phishing, and it’s only going to get better because of artificial intelligence,” he said. “No longer are you going to have typos in that email written by a hacking group in Nigeria or in China. It’s going to be perfect looking.”

What can practices and healthcare systems do? Garcia highlighted federal health agency efforts to encourage organizations to adopt best practices in cybersecurity.

“If you’ve got a data breach, and you can show to the US Department of Health & Human Services [HHS] you have implemented generally recognized cybersecurity controls over the past year, that you have done your best, you did the right thing, and you still got hit, HHS is directed to essentially take it easy on you,” he said. “That’s a positive incentive.”
 

Ransomware Guide in the Works

Dameff said UC San Diego’s Center for Healthcare Cybersecurity plans to publish a free cybersecurity guide in 2025 that will include specific information about ransomware attacks for medical specialties such as cardiology, trauma surgery, and pediatrics.

“Then, should you ever be ransomed, you can pull out this guide. You’ll know what’s going to kind of happen, and you can better prepare for those effects.”

Will the future president prioritize healthcare cybersecurity? That remains to be seen, but crises do have the capacity to concentrate the mind, experts said.

The nation’s capital “has a very short memory, a short attention span. The policymakers tend to be reactive,” Dameff said. “All it takes is yet another Change Healthcare–like attack that disrupts 30% or more of the nation’s healthcare system for the policymakers to sit up, take notice, and try to come up with solutions.”

In addition, he said, an estimated two data breaches/ransomware attacks are occurring per day. “The fact is that we’re all patients, up to the President of the United States and every member of the Congress is a patient.”

There’s a “very existential, very palpable understanding that cyber safety is patient safety and cyber insecurity is patient insecurity,” Dameff said.

A version of this article appeared on Medscape.com.

From the largest healthcare companies to solo practices, just every organization in medicine faces a risk for costly cyberattacks. In recent years, hackers have threatened to release the personal information of patients and employees — or paralyze online systems — unless they’re paid a ransom.

Should companies pay? It’s not an easy answer, a pair of experts told colleagues in an American Medical Association (AMA) cybersecurity webinar on October 18. It turns out that each choice — pay or don’t pay — can end up being costly.

This is just one of the new challenges facing the American medical system on the cybersecurity front, the speakers said. Others include the possibility that hackers will manipulate patient data — turning a medical test negative, for example, when it’s actually positive — and take advantage of the powers of artificial intelligence (AI).

The AMA held the webinar to educate physicians about cybersecurity risks and defenses, an especially hot topic in the wake of February’s Change Healthcare hack, which cost UnitedHealth Group an estimated $2.5 billion — so far — and deeply disrupted the American healthcare system.

Cautionary tales abound. Greg Garcia, executive director for cybersecurity of the Health Sector Coordinating Council, a coalition of medical industry organizations, pointed to a Pennsylvania clinic that refused to pay a ransom to prevent the release of hundreds of images of patients with breast cancer undressed from the waist up. Garcia told webinar participants that the ransom was $5 million.
 

Risky Choices

While the Federal Bureau of Investigation recommends against paying a ransom, this can be a risky choice, Garcia said. Hackers released the images, and the center has reportedly agreed to settle a class-action lawsuit for $65 million. “They traded $5 million for $60 million,” Garcia added, slightly misstating the settlement amount.

Health systems have been cagey about whether they’ve paid ransoms to prevent private data from being made public in cyberattacks. If a ransom is demanded, “it’s every organization for itself,” Garcia said.

He highlighted the case of a chain of psychiatry practices in Finland that suffered a ransomware attack in 2020. The hackers “contacted the patients and said: ‘Hey, call your clinic and tell them to pay the ransom. Otherwise, we’re going to release all your psychiatric notes to the public.’ ”

Cyberattacks continue. In October, Boston Children’s Health Physicians announced that it had suffered a “ recent security incident” involving data — possibly including Social Security numbers and treatment information — regarding patients and employees. A hacker group reportedly claimed responsibility and wants the system, which boasts more than 300 clinicians, to pay a ransom or else it will release the stolen information.
 

Should Paying Ransom Be a Crime?

Christian Dameff, MD, MS, an emergency medicine physician and director of the Center for Healthcare Cybersecurity at the University of California (UC), San Diego, noted that there are efforts to turn paying ransom into a crime. “If people aren’t paying ransoms, then ransomware operators will move to something else that makes them money.”

Dameff urged colleagues to understand we no longer live in a world where clinicians only bother to think of technology when they call the IT department to help them reset their password.

New challenges face clinicians, he said. “How do we develop better strategies, downtime procedures, and safe clinical care in an era where our vital technology may be gone, not just for an hour or 2, but as is the case with these ransomware attacks, sometimes weeks to months.”

Garcia said “cybersecurity is everybody’s responsibility, including frontline clinicians. Because you’re touching data, you’re touching technology, you’re touching patients, and all of those things combine to present some vulnerabilities in the digital world.”
 

 

 

Next Frontier: Hackers May Manipulate Patient Data

Dameff said future hackers may use AI to manipulate individual patient data in ways that threaten patient health. AI makes this easier to accomplish.

“What if I delete your allergies in your electronic health record, or I manipulate your chest x-ray, or I change your lab values so it looks like you’re in diabetic ketoacidosis when you’re not so a clinician gives you insulin when you don’t need it?”

Garcia highlighted another new threat: Phishing efforts that are harder to ignore thanks to AI.

“One of the most successful way that hackers get in, disrupt systems, and steal data is through email phishing, and it’s only going to get better because of artificial intelligence,” he said. “No longer are you going to have typos in that email written by a hacking group in Nigeria or in China. It’s going to be perfect looking.”

What can practices and healthcare systems do? Garcia highlighted federal health agency efforts to encourage organizations to adopt best practices in cybersecurity.

“If you’ve got a data breach, and you can show to the US Department of Health & Human Services [HHS] you have implemented generally recognized cybersecurity controls over the past year, that you have done your best, you did the right thing, and you still got hit, HHS is directed to essentially take it easy on you,” he said. “That’s a positive incentive.”
 

Ransomware Guide in the Works

Dameff said UC San Diego’s Center for Healthcare Cybersecurity plans to publish a free cybersecurity guide in 2025 that will include specific information about ransomware attacks for medical specialties such as cardiology, trauma surgery, and pediatrics.

“Then, should you ever be ransomed, you can pull out this guide. You’ll know what’s going to kind of happen, and you can better prepare for those effects.”

Will the future president prioritize healthcare cybersecurity? That remains to be seen, but crises do have the capacity to concentrate the mind, experts said.

The nation’s capital “has a very short memory, a short attention span. The policymakers tend to be reactive,” Dameff said. “All it takes is yet another Change Healthcare–like attack that disrupts 30% or more of the nation’s healthcare system for the policymakers to sit up, take notice, and try to come up with solutions.”

In addition, he said, an estimated two data breaches/ransomware attacks are occurring per day. “The fact is that we’re all patients, up to the President of the United States and every member of the Congress is a patient.”

There’s a “very existential, very palpable understanding that cyber safety is patient safety and cyber insecurity is patient insecurity,” Dameff said.

A version of this article appeared on Medscape.com.

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Can Better Diet Improve Survival in Black Women With Ovarian Cancer?

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Changed
Tue, 10/29/2024 - 09:36

 

TOPLINE:

Better prediagnosis dietary quality is linked to improved survival in Black women with high-grade serous ovarian cancer (HGSOC). No significant survival association was found among the full study sample, which included women with multiple types of epithelial ovarian cancer (EOC).

METHODOLOGY:

  • Researchers conducted a prospective cohort study among 483 self-identified Black women aged 20-79 years newly diagnosed with histologically confirmed EOC between December 2010 and December 2015.
  • The study aimed to examine associations between dietary patterns and survival among Black women diagnosed with EOC using data from the African American Cancer Epidemiology Study.
  • Dietary patterns were assessed using the Healthy Eating Index–2020 (HEI-2020) and Alternative Healthy Eating Index–2010 (AHEI-2010), based on dietary intake in the year prior to diagnosis collected via the validated Block 2005 Food Frequency Questionnaire (FFQ). Participant characteristics were summarized across quartiles of HEI-2020 and AHEI-2010 scores.
  • The researchers obtained and summarized clinical characteristics, including tumor characteristics, first-line treatment regimen, debulking status, residual disease, and cancer antigen 125 levels, from medical records.
  • The main outcome measure was overall survival, with hazard ratios (HRs) and 95% CIs estimated from multivariable Cox models for the association between adherence to dietary recommendations and overall mortality. Follow-up was conducted until October 2022, with data analyzed from March 2023 to June 2024.

TAKEAWAY:

  • No significant association was found between dietary patterns and overall mortality among women with EOC.
  • Among women with HGSOC, the most lethal histotype of EOC, better adherence to the HEI-2020 was associated with decreased mortality in later quartiles vs the first quartile (HR, 0.63; 95% CI, 0.44-0.92).
  • Similar results were observed with the AHEI-2010 among women with HGSOC for the second (HR, 0.62; 95% CI, 0.43-0.89) and fourth (HR, 0.67; 95% CI, 0.45-0.98) quartiles vs the first quartile.
  • Women with moderate and high prediagnosis dietary quality had significantly lower mortality rates from HGSOC than those with the lowest prediagnosis dietary quality.

IN PRACTICE:

“Our findings suggest that prediagnosis dietary patterns (ie, the combination of foods and nutrients) are more important than individual components for ovarian cancer survival as shown by comparing results of dietary patterns with individual components,” the authors of the study wrote.

SOURCE:

This study was led by Tsion A. Armidie, MPH, Rollins School of Public Health, Emory University in Atlanta, Georgia. It was published online on October 18 in JAMA Network Open.

LIMITATIONS:

This study’s limitations included the potential for residual confounding, despite accounting for a wide array of covariates. The median time between diagnosis and FFQ completion was 5.8 months, which may have introduced measurement errors in dietary recall. Additionally, the study did not collect postdiagnostic dietary information, which could have provided further insights into the association between diet and survival.

DISCLOSURES:

This study was supported by grants from the National Cancer Institute. One coauthor reported receiving personal fees from Pfizer outside the submitted work. One coauthor reported receiving grants from the US Department of Defense during the conduct of the study and Bristol-Myers Squibb and Karyopharm outside the submitted work. One coauthor reported receiving personal fees from Ashcraft and Gerel outside the submitted work. One coauthor reported receiving personal fees from Epidemiologic Research & Methods outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Better prediagnosis dietary quality is linked to improved survival in Black women with high-grade serous ovarian cancer (HGSOC). No significant survival association was found among the full study sample, which included women with multiple types of epithelial ovarian cancer (EOC).

METHODOLOGY:

  • Researchers conducted a prospective cohort study among 483 self-identified Black women aged 20-79 years newly diagnosed with histologically confirmed EOC between December 2010 and December 2015.
  • The study aimed to examine associations between dietary patterns and survival among Black women diagnosed with EOC using data from the African American Cancer Epidemiology Study.
  • Dietary patterns were assessed using the Healthy Eating Index–2020 (HEI-2020) and Alternative Healthy Eating Index–2010 (AHEI-2010), based on dietary intake in the year prior to diagnosis collected via the validated Block 2005 Food Frequency Questionnaire (FFQ). Participant characteristics were summarized across quartiles of HEI-2020 and AHEI-2010 scores.
  • The researchers obtained and summarized clinical characteristics, including tumor characteristics, first-line treatment regimen, debulking status, residual disease, and cancer antigen 125 levels, from medical records.
  • The main outcome measure was overall survival, with hazard ratios (HRs) and 95% CIs estimated from multivariable Cox models for the association between adherence to dietary recommendations and overall mortality. Follow-up was conducted until October 2022, with data analyzed from March 2023 to June 2024.

TAKEAWAY:

  • No significant association was found between dietary patterns and overall mortality among women with EOC.
  • Among women with HGSOC, the most lethal histotype of EOC, better adherence to the HEI-2020 was associated with decreased mortality in later quartiles vs the first quartile (HR, 0.63; 95% CI, 0.44-0.92).
  • Similar results were observed with the AHEI-2010 among women with HGSOC for the second (HR, 0.62; 95% CI, 0.43-0.89) and fourth (HR, 0.67; 95% CI, 0.45-0.98) quartiles vs the first quartile.
  • Women with moderate and high prediagnosis dietary quality had significantly lower mortality rates from HGSOC than those with the lowest prediagnosis dietary quality.

IN PRACTICE:

“Our findings suggest that prediagnosis dietary patterns (ie, the combination of foods and nutrients) are more important than individual components for ovarian cancer survival as shown by comparing results of dietary patterns with individual components,” the authors of the study wrote.

SOURCE:

This study was led by Tsion A. Armidie, MPH, Rollins School of Public Health, Emory University in Atlanta, Georgia. It was published online on October 18 in JAMA Network Open.

LIMITATIONS:

This study’s limitations included the potential for residual confounding, despite accounting for a wide array of covariates. The median time between diagnosis and FFQ completion was 5.8 months, which may have introduced measurement errors in dietary recall. Additionally, the study did not collect postdiagnostic dietary information, which could have provided further insights into the association between diet and survival.

DISCLOSURES:

This study was supported by grants from the National Cancer Institute. One coauthor reported receiving personal fees from Pfizer outside the submitted work. One coauthor reported receiving grants from the US Department of Defense during the conduct of the study and Bristol-Myers Squibb and Karyopharm outside the submitted work. One coauthor reported receiving personal fees from Ashcraft and Gerel outside the submitted work. One coauthor reported receiving personal fees from Epidemiologic Research & Methods outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Better prediagnosis dietary quality is linked to improved survival in Black women with high-grade serous ovarian cancer (HGSOC). No significant survival association was found among the full study sample, which included women with multiple types of epithelial ovarian cancer (EOC).

METHODOLOGY:

  • Researchers conducted a prospective cohort study among 483 self-identified Black women aged 20-79 years newly diagnosed with histologically confirmed EOC between December 2010 and December 2015.
  • The study aimed to examine associations between dietary patterns and survival among Black women diagnosed with EOC using data from the African American Cancer Epidemiology Study.
  • Dietary patterns were assessed using the Healthy Eating Index–2020 (HEI-2020) and Alternative Healthy Eating Index–2010 (AHEI-2010), based on dietary intake in the year prior to diagnosis collected via the validated Block 2005 Food Frequency Questionnaire (FFQ). Participant characteristics were summarized across quartiles of HEI-2020 and AHEI-2010 scores.
  • The researchers obtained and summarized clinical characteristics, including tumor characteristics, first-line treatment regimen, debulking status, residual disease, and cancer antigen 125 levels, from medical records.
  • The main outcome measure was overall survival, with hazard ratios (HRs) and 95% CIs estimated from multivariable Cox models for the association between adherence to dietary recommendations and overall mortality. Follow-up was conducted until October 2022, with data analyzed from March 2023 to June 2024.

TAKEAWAY:

  • No significant association was found between dietary patterns and overall mortality among women with EOC.
  • Among women with HGSOC, the most lethal histotype of EOC, better adherence to the HEI-2020 was associated with decreased mortality in later quartiles vs the first quartile (HR, 0.63; 95% CI, 0.44-0.92).
  • Similar results were observed with the AHEI-2010 among women with HGSOC for the second (HR, 0.62; 95% CI, 0.43-0.89) and fourth (HR, 0.67; 95% CI, 0.45-0.98) quartiles vs the first quartile.
  • Women with moderate and high prediagnosis dietary quality had significantly lower mortality rates from HGSOC than those with the lowest prediagnosis dietary quality.

IN PRACTICE:

“Our findings suggest that prediagnosis dietary patterns (ie, the combination of foods and nutrients) are more important than individual components for ovarian cancer survival as shown by comparing results of dietary patterns with individual components,” the authors of the study wrote.

SOURCE:

This study was led by Tsion A. Armidie, MPH, Rollins School of Public Health, Emory University in Atlanta, Georgia. It was published online on October 18 in JAMA Network Open.

LIMITATIONS:

This study’s limitations included the potential for residual confounding, despite accounting for a wide array of covariates. The median time between diagnosis and FFQ completion was 5.8 months, which may have introduced measurement errors in dietary recall. Additionally, the study did not collect postdiagnostic dietary information, which could have provided further insights into the association between diet and survival.

DISCLOSURES:

This study was supported by grants from the National Cancer Institute. One coauthor reported receiving personal fees from Pfizer outside the submitted work. One coauthor reported receiving grants from the US Department of Defense during the conduct of the study and Bristol-Myers Squibb and Karyopharm outside the submitted work. One coauthor reported receiving personal fees from Ashcraft and Gerel outside the submitted work. One coauthor reported receiving personal fees from Epidemiologic Research & Methods outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Six Tips for Media Interviews

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Changed
Mon, 10/28/2024 - 14:47

As a physician, you might be contacted by the media to provide your professional opinion and advice. Or you might be looking for media interview opportunities to market your practice or side project. And if you do research, media interviews can be an effective way to spread the word. It’s important to prepare for a media interview so that you achieve the outcome you are looking for. Here are six tips I learned from writing health articles, interviewing experts, and being interviewed myself. 

Keep your message simple. When you are a subject expert, you might think that the basics are obvious or even boring, and that the nuances are more important. However, most of the audience is looking for big-picture information that they can apply to their lives. Consider a few key takeaways, keeping in mind that your interview is likely to be edited to short sound bites or a few quotes. It may help to jot down notes so that you cover the fundamentals clearly. You could even write and rehearse a script beforehand. If there is something complicated or subtle that you want to convey, you can preface it by saying, “This is confusing but very important …” to let the audience know to give extra consideration to what you are about to say.

Avoid extremes and hyperbole. Sometimes, exaggerated statements make their way into medical discussions. Statements such as “it doesn’t matter how many calories you consume — it’s all about the quality” are common oversimplifications. But you might be upset to see your name next to a comment like this because it is not actually correct. Check the phrasing of your key takeaways to avoid being stuck defending or explaining an inaccurate statement when your patients ask you about it later. 

Ask the interviewers what they are looking for. Many medical topics have some controversial element, so it is good to know what you’re getting into. Find out the purpose of the article or interview before you decide whether it is right for you. It could be about another doctor in town who is being sued; if you don’t want to be associated with that story, it might be best to decline the interview. 

Explain your goals. You might accept or pursue an interview to raise awareness about an underrecognized condition. You might want the public to identify and get help for early symptoms, or you might want to create empathy for people coping with a disease you treat. Consider why you are participating in an interview, and communicate that to the interviewer to ensure that your objective can be part of the final product. 

Know whom you’re dealing with. It is good to learn about the publication/media channel before you agree to participate. It may have a political bias, or perhaps the interview is intended to promote a specific product. If you agree with and support their purposes, then you may be happy to lend your opinion. But learning about the “voice” of the publication in advance allows you to make an informed decision about whether you want to be identified with a particular political ideology or product endorsement.

Ask to see your quotes before publication. It’s good to have the opportunity to make corrections in case you are accidentally misquoted or misunderstood. It is best to ask to see quotes before you agree to the interview. Some reporters may agree to (or even prefer) a written question-and-answer format so that they can directly quote your responses without rephrasing your words. You could suggest this, especially if you are too busy for a call or live meeting.

As a physician, your insights and advice can be highly beneficial to others. You can also use media interviews to propel your career forward. Doing your homework can ensure that you will be pleased with the final product and how your words were used. 
 

Dr. Moawad, Clinical Assistant Professor, Department of Medical Education, Case Western Reserve University School of Medicine, Cleveland, Ohio, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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As a physician, you might be contacted by the media to provide your professional opinion and advice. Or you might be looking for media interview opportunities to market your practice or side project. And if you do research, media interviews can be an effective way to spread the word. It’s important to prepare for a media interview so that you achieve the outcome you are looking for. Here are six tips I learned from writing health articles, interviewing experts, and being interviewed myself. 

Keep your message simple. When you are a subject expert, you might think that the basics are obvious or even boring, and that the nuances are more important. However, most of the audience is looking for big-picture information that they can apply to their lives. Consider a few key takeaways, keeping in mind that your interview is likely to be edited to short sound bites or a few quotes. It may help to jot down notes so that you cover the fundamentals clearly. You could even write and rehearse a script beforehand. If there is something complicated or subtle that you want to convey, you can preface it by saying, “This is confusing but very important …” to let the audience know to give extra consideration to what you are about to say.

Avoid extremes and hyperbole. Sometimes, exaggerated statements make their way into medical discussions. Statements such as “it doesn’t matter how many calories you consume — it’s all about the quality” are common oversimplifications. But you might be upset to see your name next to a comment like this because it is not actually correct. Check the phrasing of your key takeaways to avoid being stuck defending or explaining an inaccurate statement when your patients ask you about it later. 

Ask the interviewers what they are looking for. Many medical topics have some controversial element, so it is good to know what you’re getting into. Find out the purpose of the article or interview before you decide whether it is right for you. It could be about another doctor in town who is being sued; if you don’t want to be associated with that story, it might be best to decline the interview. 

Explain your goals. You might accept or pursue an interview to raise awareness about an underrecognized condition. You might want the public to identify and get help for early symptoms, or you might want to create empathy for people coping with a disease you treat. Consider why you are participating in an interview, and communicate that to the interviewer to ensure that your objective can be part of the final product. 

Know whom you’re dealing with. It is good to learn about the publication/media channel before you agree to participate. It may have a political bias, or perhaps the interview is intended to promote a specific product. If you agree with and support their purposes, then you may be happy to lend your opinion. But learning about the “voice” of the publication in advance allows you to make an informed decision about whether you want to be identified with a particular political ideology or product endorsement.

Ask to see your quotes before publication. It’s good to have the opportunity to make corrections in case you are accidentally misquoted or misunderstood. It is best to ask to see quotes before you agree to the interview. Some reporters may agree to (or even prefer) a written question-and-answer format so that they can directly quote your responses without rephrasing your words. You could suggest this, especially if you are too busy for a call or live meeting.

As a physician, your insights and advice can be highly beneficial to others. You can also use media interviews to propel your career forward. Doing your homework can ensure that you will be pleased with the final product and how your words were used. 
 

Dr. Moawad, Clinical Assistant Professor, Department of Medical Education, Case Western Reserve University School of Medicine, Cleveland, Ohio, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

As a physician, you might be contacted by the media to provide your professional opinion and advice. Or you might be looking for media interview opportunities to market your practice or side project. And if you do research, media interviews can be an effective way to spread the word. It’s important to prepare for a media interview so that you achieve the outcome you are looking for. Here are six tips I learned from writing health articles, interviewing experts, and being interviewed myself. 

Keep your message simple. When you are a subject expert, you might think that the basics are obvious or even boring, and that the nuances are more important. However, most of the audience is looking for big-picture information that they can apply to their lives. Consider a few key takeaways, keeping in mind that your interview is likely to be edited to short sound bites or a few quotes. It may help to jot down notes so that you cover the fundamentals clearly. You could even write and rehearse a script beforehand. If there is something complicated or subtle that you want to convey, you can preface it by saying, “This is confusing but very important …” to let the audience know to give extra consideration to what you are about to say.

Avoid extremes and hyperbole. Sometimes, exaggerated statements make their way into medical discussions. Statements such as “it doesn’t matter how many calories you consume — it’s all about the quality” are common oversimplifications. But you might be upset to see your name next to a comment like this because it is not actually correct. Check the phrasing of your key takeaways to avoid being stuck defending or explaining an inaccurate statement when your patients ask you about it later. 

Ask the interviewers what they are looking for. Many medical topics have some controversial element, so it is good to know what you’re getting into. Find out the purpose of the article or interview before you decide whether it is right for you. It could be about another doctor in town who is being sued; if you don’t want to be associated with that story, it might be best to decline the interview. 

Explain your goals. You might accept or pursue an interview to raise awareness about an underrecognized condition. You might want the public to identify and get help for early symptoms, or you might want to create empathy for people coping with a disease you treat. Consider why you are participating in an interview, and communicate that to the interviewer to ensure that your objective can be part of the final product. 

Know whom you’re dealing with. It is good to learn about the publication/media channel before you agree to participate. It may have a political bias, or perhaps the interview is intended to promote a specific product. If you agree with and support their purposes, then you may be happy to lend your opinion. But learning about the “voice” of the publication in advance allows you to make an informed decision about whether you want to be identified with a particular political ideology or product endorsement.

Ask to see your quotes before publication. It’s good to have the opportunity to make corrections in case you are accidentally misquoted or misunderstood. It is best to ask to see quotes before you agree to the interview. Some reporters may agree to (or even prefer) a written question-and-answer format so that they can directly quote your responses without rephrasing your words. You could suggest this, especially if you are too busy for a call or live meeting.

As a physician, your insights and advice can be highly beneficial to others. You can also use media interviews to propel your career forward. Doing your homework can ensure that you will be pleased with the final product and how your words were used. 
 

Dr. Moawad, Clinical Assistant Professor, Department of Medical Education, Case Western Reserve University School of Medicine, Cleveland, Ohio, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Mepivacaine Reduces Pain During IUD Placement in Nulliparous Women

Article Type
Changed
Mon, 10/28/2024 - 14:16

 

TOPLINE:

Mepivacaine instillation significantly reduced pain during intrauterine device (IUD) placement in nulliparous women. More than 90% of women in the intervention group reported tolerable pain compared with 80% of those in the placebo group.

METHODOLOGY:

  • A multicenter, double-blind, randomized, placebo-controlled trial was conducted in 12 centers in Sweden, which involved 151 nulliparous women aged 18-31 years.
  • Participants were randomly assigned to receive either 10 mL of 20 mg/mL mepivacaine or 10 mL of 0.9 mg/mL sodium chloride (placebo) through a hydrosonography catheter 2 minutes before IUD placement.
  • Pain scores were measured using a 100-mm visual analog scale (VAS) at baseline, after instillation, during IUD placement, and 10 minutes post placement.
  • The primary outcome was the difference in VAS pain scores during IUD placement between the intervention and placebo groups.

TAKEAWAY:

  • Mepivacaine instillation resulted in a statistically significant reduction in mean VAS pain scores during IUD placement, with a mean difference of 13.3 mm (95% CI, 5.75-20.87; P < .001).
  • After adjusting for provider impact, the mean VAS pain score difference remained significant at 12.2 mm (95% CI, 4.85-19.62; P < .001).
  • A higher proportion of women in the mepivacaine group reported tolerable pain during IUD placement (93.3%) than the placebo group (80.3%; P = .021).
  • No serious adverse effects were associated with mepivacaine instillation, and there were no cases of uterine perforation in either group.

IN PRACTICE:

“We argue that the pain reduction in our study is clinically important as a greater proportion of women in our intervention group, compared to the placebo group, reported tolerable pain during placement and to a higher extent rated the placement as easier than expected and expressed a willingness to choose IUD as contraception again,” the authors of the study wrote.

SOURCE:

This study was led by Niklas Envall, PhD; Karin Elgemark, MD; and Helena Kopp Kallner, MD, PhD, at the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet in Stockholm, Sweden. It was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

This study’s limitations included the exclusive focus on one type of IUD (LNG-IUS 52 mg, 4.4 mm), which may limit generalizability to other IUD types. Additionally, only experienced providers participated, which may not reflect settings with less experienced providers. Factors such as anticipated pain and patient anxiety were not systematically assessed, potentially influencing pain perception.

DISCLOSURES:

Envall received personal fees from Bayer for educational activities and honorarium from Medsphere Corp USA for expert opinions on long-acting reversible contraception. Kallner received honoraria for consultancy work and lectures from multiple pharmaceutical companies, including AbbVie, Actavis, Bayer, and others. The study was funded by the Swedish Research Council. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Mepivacaine instillation significantly reduced pain during intrauterine device (IUD) placement in nulliparous women. More than 90% of women in the intervention group reported tolerable pain compared with 80% of those in the placebo group.

METHODOLOGY:

  • A multicenter, double-blind, randomized, placebo-controlled trial was conducted in 12 centers in Sweden, which involved 151 nulliparous women aged 18-31 years.
  • Participants were randomly assigned to receive either 10 mL of 20 mg/mL mepivacaine or 10 mL of 0.9 mg/mL sodium chloride (placebo) through a hydrosonography catheter 2 minutes before IUD placement.
  • Pain scores were measured using a 100-mm visual analog scale (VAS) at baseline, after instillation, during IUD placement, and 10 minutes post placement.
  • The primary outcome was the difference in VAS pain scores during IUD placement between the intervention and placebo groups.

TAKEAWAY:

  • Mepivacaine instillation resulted in a statistically significant reduction in mean VAS pain scores during IUD placement, with a mean difference of 13.3 mm (95% CI, 5.75-20.87; P < .001).
  • After adjusting for provider impact, the mean VAS pain score difference remained significant at 12.2 mm (95% CI, 4.85-19.62; P < .001).
  • A higher proportion of women in the mepivacaine group reported tolerable pain during IUD placement (93.3%) than the placebo group (80.3%; P = .021).
  • No serious adverse effects were associated with mepivacaine instillation, and there were no cases of uterine perforation in either group.

IN PRACTICE:

“We argue that the pain reduction in our study is clinically important as a greater proportion of women in our intervention group, compared to the placebo group, reported tolerable pain during placement and to a higher extent rated the placement as easier than expected and expressed a willingness to choose IUD as contraception again,” the authors of the study wrote.

SOURCE:

This study was led by Niklas Envall, PhD; Karin Elgemark, MD; and Helena Kopp Kallner, MD, PhD, at the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet in Stockholm, Sweden. It was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

This study’s limitations included the exclusive focus on one type of IUD (LNG-IUS 52 mg, 4.4 mm), which may limit generalizability to other IUD types. Additionally, only experienced providers participated, which may not reflect settings with less experienced providers. Factors such as anticipated pain and patient anxiety were not systematically assessed, potentially influencing pain perception.

DISCLOSURES:

Envall received personal fees from Bayer for educational activities and honorarium from Medsphere Corp USA for expert opinions on long-acting reversible contraception. Kallner received honoraria for consultancy work and lectures from multiple pharmaceutical companies, including AbbVie, Actavis, Bayer, and others. The study was funded by the Swedish Research Council. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Mepivacaine instillation significantly reduced pain during intrauterine device (IUD) placement in nulliparous women. More than 90% of women in the intervention group reported tolerable pain compared with 80% of those in the placebo group.

METHODOLOGY:

  • A multicenter, double-blind, randomized, placebo-controlled trial was conducted in 12 centers in Sweden, which involved 151 nulliparous women aged 18-31 years.
  • Participants were randomly assigned to receive either 10 mL of 20 mg/mL mepivacaine or 10 mL of 0.9 mg/mL sodium chloride (placebo) through a hydrosonography catheter 2 minutes before IUD placement.
  • Pain scores were measured using a 100-mm visual analog scale (VAS) at baseline, after instillation, during IUD placement, and 10 minutes post placement.
  • The primary outcome was the difference in VAS pain scores during IUD placement between the intervention and placebo groups.

TAKEAWAY:

  • Mepivacaine instillation resulted in a statistically significant reduction in mean VAS pain scores during IUD placement, with a mean difference of 13.3 mm (95% CI, 5.75-20.87; P < .001).
  • After adjusting for provider impact, the mean VAS pain score difference remained significant at 12.2 mm (95% CI, 4.85-19.62; P < .001).
  • A higher proportion of women in the mepivacaine group reported tolerable pain during IUD placement (93.3%) than the placebo group (80.3%; P = .021).
  • No serious adverse effects were associated with mepivacaine instillation, and there were no cases of uterine perforation in either group.

IN PRACTICE:

“We argue that the pain reduction in our study is clinically important as a greater proportion of women in our intervention group, compared to the placebo group, reported tolerable pain during placement and to a higher extent rated the placement as easier than expected and expressed a willingness to choose IUD as contraception again,” the authors of the study wrote.

SOURCE:

This study was led by Niklas Envall, PhD; Karin Elgemark, MD; and Helena Kopp Kallner, MD, PhD, at the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet in Stockholm, Sweden. It was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

This study’s limitations included the exclusive focus on one type of IUD (LNG-IUS 52 mg, 4.4 mm), which may limit generalizability to other IUD types. Additionally, only experienced providers participated, which may not reflect settings with less experienced providers. Factors such as anticipated pain and patient anxiety were not systematically assessed, potentially influencing pain perception.

DISCLOSURES:

Envall received personal fees from Bayer for educational activities and honorarium from Medsphere Corp USA for expert opinions on long-acting reversible contraception. Kallner received honoraria for consultancy work and lectures from multiple pharmaceutical companies, including AbbVie, Actavis, Bayer, and others. The study was funded by the Swedish Research Council. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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‘Small Increase’ in Breast Cancer With Levonorgestrel IUD?

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Mon, 10/28/2024 - 14:08

 

TOPLINE: 

The use of a levonorgestrel-releasing intrauterine system (LNG-IUS) is associated with an increased risk for breast cancer. An analysis by Danish researchers found 14 extra cases of breast cancer per 10,000 women using this type of an intrauterine device (IUD) vs women not using hormonal contraceptives.

METHODOLOGY:

  • The investigators used nationwide registries in Denmark to identify all women aged 15-49 years who were first-time initiators of any LNG-IUS between 2000 and 2019.
  • They matched 78,595 new users of LNG-IUS 1:1 with women with the same birth year who were not taking hormonal contraceptives.
  • Participants were followed through 2022 or until a diagnosis of breast cancer or another malignancy, pregnancy, the initiation of postmenopausal hormone therapy, emigration, or death.
  • The investigators used a Cox proportional hazards model to examine the association between the continuous use of LNG-IUS and breast cancer. Their analysis adjusted for variables such as the duration of previous hormonal contraception, fertility drugs, parity, age at first delivery, polycystic ovarian syndrome, endometriosis, and education.

TAKEAWAY:

  • Compared with the nonuse of hormonal contraceptives, the continuous use of LNG-IUS was associated with a hazard ratio for breast cancer of 1.4 (95% CI, 1.2-1.5).
  • The use of a levonorgestrel IUD for 5 years or less was associated with a hazard ratio of 1.3 (95% CI, 1.1-1.5). With 5-10 years of use, the hazard ratio was 1.4 (95% CI, 1.1-1.7). And with 10-15 years of use, the hazard ratio was 1.8 (95% CI, 1.2-2.6). A test for trend was not significant, however, and “risk did not increase with duration of use,” the study authors wrote.

IN PRACTICE:

“Women should be aware that most types of hormonal contraceptive are associated with a small increased risk of breast cancer. This study adds another type of hormonal contraceptive to that list,” Amy Berrington de Gonzalez, DPhil, professor of clinical cancer epidemiology at The Institute of Cancer Research in London, England, said in comments on the research. “That has to be considered with the many benefits from hormonal contraceptives.”

Behaviors such as smoking could have differed between the groups in the study, and it has not been established that LNG-IUS use directly causes an increased risk for breast cancer, said Channa Jayasena, PhD, an endocrinologist at Imperial College London.

“Smoking, alcohol and obesity are much more important risk factors for breast cancer than contraceptive medications,” he said. “My advice for women is that breast cancer risk caused by LNG-IUS is not established but warrants a closer look.”
 

SOURCE:

Lina Steinrud Mørch, MSc, PhD, with the Danish Cancer Institute in Copenhagen, Denmark, was the corresponding author of the study. The researchers published their findings in JAMA.

LIMITATIONS: 

Unmeasured confounding was possible, and the lack of a significant dose-response relationship “could indicate low statistical precision or no causal association,” the researchers noted.

DISCLOSURES:

The study was funded by Sundhedsdonationer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE: 

The use of a levonorgestrel-releasing intrauterine system (LNG-IUS) is associated with an increased risk for breast cancer. An analysis by Danish researchers found 14 extra cases of breast cancer per 10,000 women using this type of an intrauterine device (IUD) vs women not using hormonal contraceptives.

METHODOLOGY:

  • The investigators used nationwide registries in Denmark to identify all women aged 15-49 years who were first-time initiators of any LNG-IUS between 2000 and 2019.
  • They matched 78,595 new users of LNG-IUS 1:1 with women with the same birth year who were not taking hormonal contraceptives.
  • Participants were followed through 2022 or until a diagnosis of breast cancer or another malignancy, pregnancy, the initiation of postmenopausal hormone therapy, emigration, or death.
  • The investigators used a Cox proportional hazards model to examine the association between the continuous use of LNG-IUS and breast cancer. Their analysis adjusted for variables such as the duration of previous hormonal contraception, fertility drugs, parity, age at first delivery, polycystic ovarian syndrome, endometriosis, and education.

TAKEAWAY:

  • Compared with the nonuse of hormonal contraceptives, the continuous use of LNG-IUS was associated with a hazard ratio for breast cancer of 1.4 (95% CI, 1.2-1.5).
  • The use of a levonorgestrel IUD for 5 years or less was associated with a hazard ratio of 1.3 (95% CI, 1.1-1.5). With 5-10 years of use, the hazard ratio was 1.4 (95% CI, 1.1-1.7). And with 10-15 years of use, the hazard ratio was 1.8 (95% CI, 1.2-2.6). A test for trend was not significant, however, and “risk did not increase with duration of use,” the study authors wrote.

IN PRACTICE:

“Women should be aware that most types of hormonal contraceptive are associated with a small increased risk of breast cancer. This study adds another type of hormonal contraceptive to that list,” Amy Berrington de Gonzalez, DPhil, professor of clinical cancer epidemiology at The Institute of Cancer Research in London, England, said in comments on the research. “That has to be considered with the many benefits from hormonal contraceptives.”

Behaviors such as smoking could have differed between the groups in the study, and it has not been established that LNG-IUS use directly causes an increased risk for breast cancer, said Channa Jayasena, PhD, an endocrinologist at Imperial College London.

“Smoking, alcohol and obesity are much more important risk factors for breast cancer than contraceptive medications,” he said. “My advice for women is that breast cancer risk caused by LNG-IUS is not established but warrants a closer look.”
 

SOURCE:

Lina Steinrud Mørch, MSc, PhD, with the Danish Cancer Institute in Copenhagen, Denmark, was the corresponding author of the study. The researchers published their findings in JAMA.

LIMITATIONS: 

Unmeasured confounding was possible, and the lack of a significant dose-response relationship “could indicate low statistical precision or no causal association,” the researchers noted.

DISCLOSURES:

The study was funded by Sundhedsdonationer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE: 

The use of a levonorgestrel-releasing intrauterine system (LNG-IUS) is associated with an increased risk for breast cancer. An analysis by Danish researchers found 14 extra cases of breast cancer per 10,000 women using this type of an intrauterine device (IUD) vs women not using hormonal contraceptives.

METHODOLOGY:

  • The investigators used nationwide registries in Denmark to identify all women aged 15-49 years who were first-time initiators of any LNG-IUS between 2000 and 2019.
  • They matched 78,595 new users of LNG-IUS 1:1 with women with the same birth year who were not taking hormonal contraceptives.
  • Participants were followed through 2022 or until a diagnosis of breast cancer or another malignancy, pregnancy, the initiation of postmenopausal hormone therapy, emigration, or death.
  • The investigators used a Cox proportional hazards model to examine the association between the continuous use of LNG-IUS and breast cancer. Their analysis adjusted for variables such as the duration of previous hormonal contraception, fertility drugs, parity, age at first delivery, polycystic ovarian syndrome, endometriosis, and education.

TAKEAWAY:

  • Compared with the nonuse of hormonal contraceptives, the continuous use of LNG-IUS was associated with a hazard ratio for breast cancer of 1.4 (95% CI, 1.2-1.5).
  • The use of a levonorgestrel IUD for 5 years or less was associated with a hazard ratio of 1.3 (95% CI, 1.1-1.5). With 5-10 years of use, the hazard ratio was 1.4 (95% CI, 1.1-1.7). And with 10-15 years of use, the hazard ratio was 1.8 (95% CI, 1.2-2.6). A test for trend was not significant, however, and “risk did not increase with duration of use,” the study authors wrote.

IN PRACTICE:

“Women should be aware that most types of hormonal contraceptive are associated with a small increased risk of breast cancer. This study adds another type of hormonal contraceptive to that list,” Amy Berrington de Gonzalez, DPhil, professor of clinical cancer epidemiology at The Institute of Cancer Research in London, England, said in comments on the research. “That has to be considered with the many benefits from hormonal contraceptives.”

Behaviors such as smoking could have differed between the groups in the study, and it has not been established that LNG-IUS use directly causes an increased risk for breast cancer, said Channa Jayasena, PhD, an endocrinologist at Imperial College London.

“Smoking, alcohol and obesity are much more important risk factors for breast cancer than contraceptive medications,” he said. “My advice for women is that breast cancer risk caused by LNG-IUS is not established but warrants a closer look.”
 

SOURCE:

Lina Steinrud Mørch, MSc, PhD, with the Danish Cancer Institute in Copenhagen, Denmark, was the corresponding author of the study. The researchers published their findings in JAMA.

LIMITATIONS: 

Unmeasured confounding was possible, and the lack of a significant dose-response relationship “could indicate low statistical precision or no causal association,” the researchers noted.

DISCLOSURES:

The study was funded by Sundhedsdonationer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Cancer’s Other Toll: Long-Term Financial Fallout for Survivors

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Changed
Mon, 10/28/2024 - 14:04

— While the physical toll of cancer is well documented, the financial toll can also be severe and lasting.

Overall, patients with cancer tend to face higher rates of debt collection, medical collections, and bankruptcies, as well as lower credit scores, according to two new studies presented at the American College of Surgeons Clinical Congress 2024.

“These are the first studies to provide numerical evidence of financial toxicity among cancer survivors,” Benjamin C. James, MD, with Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, Massachusetts, who worked on both studies, said in a statement. “Previous data on this topic largely relies on subjective survey reviews.”

In one study, researchers used the Massachusetts Cancer Registry to identify 99,175 patients diagnosed with cancer between 2010 and 2019 and matched them with 188,875 control individuals without cancer. Researchers then assessed financial toxicity using Experian credit bureau data for participants.

Overall, patients with cancer faced a range of financial challenges that often lasted years following their diagnosis.

Patients were nearly five times more likely to experience bankruptcy and had average credit scores nearly 80 points lower than control individuals without cancer. The drop in credit scores was more pronounced for survivors of bladder, liver, lung, and colorectal cancer (CRC) and persisted for up to 9.5 years.

For certain cancer types, in particular, “we are looking years after a diagnosis, and we see that the credit score goes down and it never comes back up,” James said.

The other study, which used a sample of 7227 patients with CRC from Massachusetts, identified several factors that correlated with lower credit scores.

Compared with patients who only had surgery, peers who underwent radiation only experienced a 62-point drop in their credit score after their diagnosis, while those who had chemotherapy alone had just over a 14-point drop in their credit score. Among patients who had combination treatments, those who underwent both surgery and radiation experienced a nearly 16-point drop in their credit score and those who had surgery and chemoradiation actually experienced a 2.59 bump, compared with those who had surgery alone.

Financial toxicity was worse for patients younger than 62 years, those identifying as Black or Hispanic individuals, unmarried individuals, those with an annual income below $52,000, and those living in deprived areas.

The studies add to findings from the 2015 North American Thyroid Cancer Survivorship Study, which reported that 50% of thyroid cancer survivors encountered financial toxicity because of their diagnosis.

James said the persistent financial strain of cancer care, even in a state like Massachusetts, which mandates universal healthcare, underscores the need for “broader policy changes and reforms, including reconsidering debt collection practices.”

“Financial security should be a priority in cancer care,” he added.

The studies had no specific funding. The authors have disclosed no relevant conflict of interest.

A version of this article first appeared on Medscape.com.

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— While the physical toll of cancer is well documented, the financial toll can also be severe and lasting.

Overall, patients with cancer tend to face higher rates of debt collection, medical collections, and bankruptcies, as well as lower credit scores, according to two new studies presented at the American College of Surgeons Clinical Congress 2024.

“These are the first studies to provide numerical evidence of financial toxicity among cancer survivors,” Benjamin C. James, MD, with Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, Massachusetts, who worked on both studies, said in a statement. “Previous data on this topic largely relies on subjective survey reviews.”

In one study, researchers used the Massachusetts Cancer Registry to identify 99,175 patients diagnosed with cancer between 2010 and 2019 and matched them with 188,875 control individuals without cancer. Researchers then assessed financial toxicity using Experian credit bureau data for participants.

Overall, patients with cancer faced a range of financial challenges that often lasted years following their diagnosis.

Patients were nearly five times more likely to experience bankruptcy and had average credit scores nearly 80 points lower than control individuals without cancer. The drop in credit scores was more pronounced for survivors of bladder, liver, lung, and colorectal cancer (CRC) and persisted for up to 9.5 years.

For certain cancer types, in particular, “we are looking years after a diagnosis, and we see that the credit score goes down and it never comes back up,” James said.

The other study, which used a sample of 7227 patients with CRC from Massachusetts, identified several factors that correlated with lower credit scores.

Compared with patients who only had surgery, peers who underwent radiation only experienced a 62-point drop in their credit score after their diagnosis, while those who had chemotherapy alone had just over a 14-point drop in their credit score. Among patients who had combination treatments, those who underwent both surgery and radiation experienced a nearly 16-point drop in their credit score and those who had surgery and chemoradiation actually experienced a 2.59 bump, compared with those who had surgery alone.

Financial toxicity was worse for patients younger than 62 years, those identifying as Black or Hispanic individuals, unmarried individuals, those with an annual income below $52,000, and those living in deprived areas.

The studies add to findings from the 2015 North American Thyroid Cancer Survivorship Study, which reported that 50% of thyroid cancer survivors encountered financial toxicity because of their diagnosis.

James said the persistent financial strain of cancer care, even in a state like Massachusetts, which mandates universal healthcare, underscores the need for “broader policy changes and reforms, including reconsidering debt collection practices.”

“Financial security should be a priority in cancer care,” he added.

The studies had no specific funding. The authors have disclosed no relevant conflict of interest.

A version of this article first appeared on Medscape.com.

— While the physical toll of cancer is well documented, the financial toll can also be severe and lasting.

Overall, patients with cancer tend to face higher rates of debt collection, medical collections, and bankruptcies, as well as lower credit scores, according to two new studies presented at the American College of Surgeons Clinical Congress 2024.

“These are the first studies to provide numerical evidence of financial toxicity among cancer survivors,” Benjamin C. James, MD, with Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, Massachusetts, who worked on both studies, said in a statement. “Previous data on this topic largely relies on subjective survey reviews.”

In one study, researchers used the Massachusetts Cancer Registry to identify 99,175 patients diagnosed with cancer between 2010 and 2019 and matched them with 188,875 control individuals without cancer. Researchers then assessed financial toxicity using Experian credit bureau data for participants.

Overall, patients with cancer faced a range of financial challenges that often lasted years following their diagnosis.

Patients were nearly five times more likely to experience bankruptcy and had average credit scores nearly 80 points lower than control individuals without cancer. The drop in credit scores was more pronounced for survivors of bladder, liver, lung, and colorectal cancer (CRC) and persisted for up to 9.5 years.

For certain cancer types, in particular, “we are looking years after a diagnosis, and we see that the credit score goes down and it never comes back up,” James said.

The other study, which used a sample of 7227 patients with CRC from Massachusetts, identified several factors that correlated with lower credit scores.

Compared with patients who only had surgery, peers who underwent radiation only experienced a 62-point drop in their credit score after their diagnosis, while those who had chemotherapy alone had just over a 14-point drop in their credit score. Among patients who had combination treatments, those who underwent both surgery and radiation experienced a nearly 16-point drop in their credit score and those who had surgery and chemoradiation actually experienced a 2.59 bump, compared with those who had surgery alone.

Financial toxicity was worse for patients younger than 62 years, those identifying as Black or Hispanic individuals, unmarried individuals, those with an annual income below $52,000, and those living in deprived areas.

The studies add to findings from the 2015 North American Thyroid Cancer Survivorship Study, which reported that 50% of thyroid cancer survivors encountered financial toxicity because of their diagnosis.

James said the persistent financial strain of cancer care, even in a state like Massachusetts, which mandates universal healthcare, underscores the need for “broader policy changes and reforms, including reconsidering debt collection practices.”

“Financial security should be a priority in cancer care,” he added.

The studies had no specific funding. The authors have disclosed no relevant conflict of interest.

A version of this article first appeared on Medscape.com.

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Air Pollution Exposure Linked to Higher Breast Cancer Risk

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Changed
Mon, 10/28/2024 - 09:57

 

TOPLINE: 

A recent study found that long-term exposure to fine particulate matter ≤ 2.5 μm (PM2.5) is associated with an increased risk for breast cancer, with the highest risk observed among White women.

METHODOLOGY:

  • Studies have suggested that exposure to air pollution — specifically PM2.5 — may increase the risk for breast cancer, but data are largely in populations of White women.
  • The current analysis explored the potential risk among a more racially and ethnically diverse group.
  • The study included 58,358 women (median age, 60.4 years at enrollment) from the California Cancer Registry, followed over an average of 19.3 years. Overall, 35% were African American, 39% were Latino, 15% were White, and 10% were Japanese American.
  • Researchers measured PM2.5 exposure using satellite-based data and geocoded addresses. Other pollutants, such as PM10, NO2, NOX, and CO, were also tracked using Environmental Protection Agency data.

TAKEAWAY:

  • A total of 3524 invasive breast cancer cases were diagnosed over an average follow-up period of 19.3 years. PM2.5 exposure was associated with a 28% increased risk for breast cancer overall (hazard ratio [HR], 1.28; 95% CI, 1.08-1.51).
  • When looking at risk by racial/ethnic group, the association between PM2.5 exposure and breast cancer risk was strongest among White women (HR, 1.67). PM2.5 exposure was also associated with a higher risk for breast cancer among African American women (HR, 1.14; 95% CI, 0.89-1.46) and Latino women (HR, 1.34; 95% CI, 0.94-1.92), but the associations were not significant.
  • Overall breast cancer incidence was also positively associated with exposure to NO2, NOX, and CO (HRs, 1.09-1.11), but the associations were not significant. A meta-analysis of this study and ten other cohorts estimated a 5% increased breast cancer incidence per 10-unit increase in PM2.5 (HR, 1.05).

IN PRACTICE:

“Collective findings suggest that PM2.5 exposure should be considered a risk factor for breast cancer, and curtailing air pollution exposures at the population level using regulatory strategies should be a priority,” the authors concluded.

SOURCE:

The study, led by Anna H. Wu, PhD, MPH, Keck School of Medicine, University of Southern California, Los Angeles, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study did not include data on nonresidential exposures or residential history before cohort entry, which limited the assessment of earlier exposures. The study also lacked information on specific sources of PM emissions, as well as an explanation for why White women had the highest breast cancer risk compared with other racial/ethnic groups.

DISCLOSURES:

The study was supported by grants from the Health Effects Air Pollution Foundation, the National Cancer Institute, USC Environmental Exposures, Host Factors, and Human Disease, and the California Air Resource Board. One author disclosed being an associate editor for the Journal of Clinical Oncology. No other potential conflicts of interest were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE: 

A recent study found that long-term exposure to fine particulate matter ≤ 2.5 μm (PM2.5) is associated with an increased risk for breast cancer, with the highest risk observed among White women.

METHODOLOGY:

  • Studies have suggested that exposure to air pollution — specifically PM2.5 — may increase the risk for breast cancer, but data are largely in populations of White women.
  • The current analysis explored the potential risk among a more racially and ethnically diverse group.
  • The study included 58,358 women (median age, 60.4 years at enrollment) from the California Cancer Registry, followed over an average of 19.3 years. Overall, 35% were African American, 39% were Latino, 15% were White, and 10% were Japanese American.
  • Researchers measured PM2.5 exposure using satellite-based data and geocoded addresses. Other pollutants, such as PM10, NO2, NOX, and CO, were also tracked using Environmental Protection Agency data.

TAKEAWAY:

  • A total of 3524 invasive breast cancer cases were diagnosed over an average follow-up period of 19.3 years. PM2.5 exposure was associated with a 28% increased risk for breast cancer overall (hazard ratio [HR], 1.28; 95% CI, 1.08-1.51).
  • When looking at risk by racial/ethnic group, the association between PM2.5 exposure and breast cancer risk was strongest among White women (HR, 1.67). PM2.5 exposure was also associated with a higher risk for breast cancer among African American women (HR, 1.14; 95% CI, 0.89-1.46) and Latino women (HR, 1.34; 95% CI, 0.94-1.92), but the associations were not significant.
  • Overall breast cancer incidence was also positively associated with exposure to NO2, NOX, and CO (HRs, 1.09-1.11), but the associations were not significant. A meta-analysis of this study and ten other cohorts estimated a 5% increased breast cancer incidence per 10-unit increase in PM2.5 (HR, 1.05).

IN PRACTICE:

“Collective findings suggest that PM2.5 exposure should be considered a risk factor for breast cancer, and curtailing air pollution exposures at the population level using regulatory strategies should be a priority,” the authors concluded.

SOURCE:

The study, led by Anna H. Wu, PhD, MPH, Keck School of Medicine, University of Southern California, Los Angeles, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study did not include data on nonresidential exposures or residential history before cohort entry, which limited the assessment of earlier exposures. The study also lacked information on specific sources of PM emissions, as well as an explanation for why White women had the highest breast cancer risk compared with other racial/ethnic groups.

DISCLOSURES:

The study was supported by grants from the Health Effects Air Pollution Foundation, the National Cancer Institute, USC Environmental Exposures, Host Factors, and Human Disease, and the California Air Resource Board. One author disclosed being an associate editor for the Journal of Clinical Oncology. No other potential conflicts of interest were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE: 

A recent study found that long-term exposure to fine particulate matter ≤ 2.5 μm (PM2.5) is associated with an increased risk for breast cancer, with the highest risk observed among White women.

METHODOLOGY:

  • Studies have suggested that exposure to air pollution — specifically PM2.5 — may increase the risk for breast cancer, but data are largely in populations of White women.
  • The current analysis explored the potential risk among a more racially and ethnically diverse group.
  • The study included 58,358 women (median age, 60.4 years at enrollment) from the California Cancer Registry, followed over an average of 19.3 years. Overall, 35% were African American, 39% were Latino, 15% were White, and 10% were Japanese American.
  • Researchers measured PM2.5 exposure using satellite-based data and geocoded addresses. Other pollutants, such as PM10, NO2, NOX, and CO, were also tracked using Environmental Protection Agency data.

TAKEAWAY:

  • A total of 3524 invasive breast cancer cases were diagnosed over an average follow-up period of 19.3 years. PM2.5 exposure was associated with a 28% increased risk for breast cancer overall (hazard ratio [HR], 1.28; 95% CI, 1.08-1.51).
  • When looking at risk by racial/ethnic group, the association between PM2.5 exposure and breast cancer risk was strongest among White women (HR, 1.67). PM2.5 exposure was also associated with a higher risk for breast cancer among African American women (HR, 1.14; 95% CI, 0.89-1.46) and Latino women (HR, 1.34; 95% CI, 0.94-1.92), but the associations were not significant.
  • Overall breast cancer incidence was also positively associated with exposure to NO2, NOX, and CO (HRs, 1.09-1.11), but the associations were not significant. A meta-analysis of this study and ten other cohorts estimated a 5% increased breast cancer incidence per 10-unit increase in PM2.5 (HR, 1.05).

IN PRACTICE:

“Collective findings suggest that PM2.5 exposure should be considered a risk factor for breast cancer, and curtailing air pollution exposures at the population level using regulatory strategies should be a priority,” the authors concluded.

SOURCE:

The study, led by Anna H. Wu, PhD, MPH, Keck School of Medicine, University of Southern California, Los Angeles, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study did not include data on nonresidential exposures or residential history before cohort entry, which limited the assessment of earlier exposures. The study also lacked information on specific sources of PM emissions, as well as an explanation for why White women had the highest breast cancer risk compared with other racial/ethnic groups.

DISCLOSURES:

The study was supported by grants from the Health Effects Air Pollution Foundation, the National Cancer Institute, USC Environmental Exposures, Host Factors, and Human Disease, and the California Air Resource Board. One author disclosed being an associate editor for the Journal of Clinical Oncology. No other potential conflicts of interest were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Industry Payments to Peer Reviewers Scrutinized at Four Major Medical Journals

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Thu, 10/24/2024 - 09:35

 

TOPLINE: 

More than half of the US peer reviewers for four major medical journals received industry payments between 2020-2022, new research shows. Altogether they received more than $64 million in general, non-research payments, with a median payment per physician of $7614. Research payments — including money paid directly to physicians as well as funds related to research for which a physician was registered as a principal investigator — exceeded $1 billion.

METHODOLOGY:

  • Researchers identified peer reviewers in 2022 for The BMJJAMAThe Lancet, and The New England Journal of Medicine using each journal’s list of reviewers for that year. They included 1962 US-based physicians in their analysis.
  • General and research payments made to the peer reviewers between 2020-2022 were extracted from the Open Payments database.

TAKEAWAY:

  • Nearly 59% of the peer reviewers received industry payments between 2020-2022.
  • Payments included $34.31 million in consulting fees and $11.8 million for speaking compensation unrelated to continuing medical education programs.
  • Male reviewers received a significantly higher median total payment than did female reviewers ($38,959 vs $19,586). General payments were higher for men as well ($8663 vs $4183).
  • For comparison, the median general payment to all physicians in 2018 was $216, the researchers noted.

IN PRACTICE:

“Additional research and transparency regarding industry payments in the peer review process are needed,” the authors of the study wrote.

SOURCE:

Christopher J. D. Wallis, MD, PhD, with the division of urology at the University of Toronto, Canada, was the corresponding author for the study. The article was published online October 10 in JAMA.

LIMITATIONS: 

Whether the financial ties were relevant to any of the papers that the peer reviewers critiqued is not known. Some reviewers might have received additional payments from insurance and technology companies that were not captured in this study. The findings might not apply to other journals, the researchers noted. 

DISCLOSURES:

Wallis disclosed personal fees from Janssen Oncology, Nanostics, Precision Point Specialty, Sesen Bio, AbbVie, Astellas, AstraZeneca, Bayer, EMD Serono, Knight Therapeutics, Merck, Science and Medicine Canada, TerSera, and Tolmar. He and some coauthors also disclosed support and grants from foundations and government institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE: 

More than half of the US peer reviewers for four major medical journals received industry payments between 2020-2022, new research shows. Altogether they received more than $64 million in general, non-research payments, with a median payment per physician of $7614. Research payments — including money paid directly to physicians as well as funds related to research for which a physician was registered as a principal investigator — exceeded $1 billion.

METHODOLOGY:

  • Researchers identified peer reviewers in 2022 for The BMJJAMAThe Lancet, and The New England Journal of Medicine using each journal’s list of reviewers for that year. They included 1962 US-based physicians in their analysis.
  • General and research payments made to the peer reviewers between 2020-2022 were extracted from the Open Payments database.

TAKEAWAY:

  • Nearly 59% of the peer reviewers received industry payments between 2020-2022.
  • Payments included $34.31 million in consulting fees and $11.8 million for speaking compensation unrelated to continuing medical education programs.
  • Male reviewers received a significantly higher median total payment than did female reviewers ($38,959 vs $19,586). General payments were higher for men as well ($8663 vs $4183).
  • For comparison, the median general payment to all physicians in 2018 was $216, the researchers noted.

IN PRACTICE:

“Additional research and transparency regarding industry payments in the peer review process are needed,” the authors of the study wrote.

SOURCE:

Christopher J. D. Wallis, MD, PhD, with the division of urology at the University of Toronto, Canada, was the corresponding author for the study. The article was published online October 10 in JAMA.

LIMITATIONS: 

Whether the financial ties were relevant to any of the papers that the peer reviewers critiqued is not known. Some reviewers might have received additional payments from insurance and technology companies that were not captured in this study. The findings might not apply to other journals, the researchers noted. 

DISCLOSURES:

Wallis disclosed personal fees from Janssen Oncology, Nanostics, Precision Point Specialty, Sesen Bio, AbbVie, Astellas, AstraZeneca, Bayer, EMD Serono, Knight Therapeutics, Merck, Science and Medicine Canada, TerSera, and Tolmar. He and some coauthors also disclosed support and grants from foundations and government institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

 

TOPLINE: 

More than half of the US peer reviewers for four major medical journals received industry payments between 2020-2022, new research shows. Altogether they received more than $64 million in general, non-research payments, with a median payment per physician of $7614. Research payments — including money paid directly to physicians as well as funds related to research for which a physician was registered as a principal investigator — exceeded $1 billion.

METHODOLOGY:

  • Researchers identified peer reviewers in 2022 for The BMJJAMAThe Lancet, and The New England Journal of Medicine using each journal’s list of reviewers for that year. They included 1962 US-based physicians in their analysis.
  • General and research payments made to the peer reviewers between 2020-2022 were extracted from the Open Payments database.

TAKEAWAY:

  • Nearly 59% of the peer reviewers received industry payments between 2020-2022.
  • Payments included $34.31 million in consulting fees and $11.8 million for speaking compensation unrelated to continuing medical education programs.
  • Male reviewers received a significantly higher median total payment than did female reviewers ($38,959 vs $19,586). General payments were higher for men as well ($8663 vs $4183).
  • For comparison, the median general payment to all physicians in 2018 was $216, the researchers noted.

IN PRACTICE:

“Additional research and transparency regarding industry payments in the peer review process are needed,” the authors of the study wrote.

SOURCE:

Christopher J. D. Wallis, MD, PhD, with the division of urology at the University of Toronto, Canada, was the corresponding author for the study. The article was published online October 10 in JAMA.

LIMITATIONS: 

Whether the financial ties were relevant to any of the papers that the peer reviewers critiqued is not known. Some reviewers might have received additional payments from insurance and technology companies that were not captured in this study. The findings might not apply to other journals, the researchers noted. 

DISCLOSURES:

Wallis disclosed personal fees from Janssen Oncology, Nanostics, Precision Point Specialty, Sesen Bio, AbbVie, Astellas, AstraZeneca, Bayer, EMD Serono, Knight Therapeutics, Merck, Science and Medicine Canada, TerSera, and Tolmar. He and some coauthors also disclosed support and grants from foundations and government institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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