CHEST Physician

Artificial intelligence (AI) models are typically a year out of date and have this “charming problem of hallucinating made-up data and saying it with all the certainty of an attending on rounds,” Isaac Kohane, MD, PhD, Harvard Medical School, Boston, told a packed audience at plenary at an annual scientific meeting on infectious diseases.

Dr. Kohane, chair of the department of biomedical informatics, says the future intersection between AI and health care is “muddy.”

Echoing questions about the accuracy of new AI tools, researchers at the meeting presented the results of their new test of ChatGPT.

The AI chatbot is designed for language processing – not scientific accuracy – and does not guarantee that responses to medical queries are fully factual.

To test the accuracy of ChatGPT’s version 3.5, the researchers asked it if there are any boxed warnings on the U.S. Food and Drug Administration’s label for common antibiotics, and if so, what they are.

ChatGPT provided correct answers about FDA boxed warnings for only 12 of the 41 antibiotics queried – a matching rate of just 29%.

For the other 29 antibiotics, ChatGPT either “incorrectly reported that there was an FDA boxed warning when there was not, or inaccurately or incorrectly reported the boxed warning,” Rebecca Linfield, MD, infectious diseases fellow, Stanford (Calif.) University, said in an interview.
 

Uncritical AI use risky

Nine of the 41 antibiotics included in the query have boxed warnings. And ChatGPT correctly identified all nine, but only three were the matching adverse event (33%). For the 32 antibiotics without an FDA boxed warning, ChatGPT correctly reported that 28% (9 of 32) do not have a boxed warning.

For example, ChatGPT stated that the antibiotic fidaxomicin has a boxed warning for increased risk for Clostridioides difficile, “but it is the first-line antibiotic used to treat C. difficile,” Dr. Linfield pointed out.

ChatGPT also reported that cefepime increased the risk for death in those with pneumonia and fabricated a study supporting that assertion. “However, cefepime is a first-line drug for those with hospital-acquired pneumonia,” Dr. Linfield explained.

“I can imagine a worried family member finding this through ChatGPT, and needing to have extensive reassurances from the patient’s physicians about why this antibiotic was chosen,” she said.

ChatGPT also incorrectly stated that aztreonam has a boxed warning for increased mortality.

“The risk is that both physicians and the public uncritically use ChatGPT as an easily accessible, readable source of clinically validated information, when these large language models are meant to generate fluid text, and not necessarily accurate information,” Dr. Linfield told this news organization.

Dr. Linfield said that the next step is to compare the ChatGPT 3.5 used in this analysis with ChatGPT 4, as well as with Google’s Med-PaLM 2 after it is released to the public.
 

Advancing fast

At plenary, Dr. Kohane pointed out that AI is a quick learner and improvements in tools are coming fast.

As an example, just 3 years ago, the best AI tool could score about as well as the worst student taking the medical boards, he told the audience. “Three years later, the leading large language models are scoring better than 90% of all the candidates. What’s it going to be doing next year?” he asked.

“I don’t know,” Dr. Kohane said, “but it will be better than this year.” AI will “transform health care.”

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

Artificial intelligence (AI) models are typically a year out of date and have this “charming problem of hallucinating made-up data and saying it with all the certainty of an attending on rounds,” Isaac Kohane, MD, PhD, Harvard Medical School, Boston, told a packed audience at plenary at an annual scientific meeting on infectious diseases.

Dr. Kohane, chair of the department of biomedical informatics, says the future intersection between AI and health care is “muddy.”

Echoing questions about the accuracy of new AI tools, researchers at the meeting presented the results of their new test of ChatGPT.

The AI chatbot is designed for language processing – not scientific accuracy – and does not guarantee that responses to medical queries are fully factual.

To test the accuracy of ChatGPT’s version 3.5, the researchers asked it if there are any boxed warnings on the U.S. Food and Drug Administration’s label for common antibiotics, and if so, what they are.

ChatGPT provided correct answers about FDA boxed warnings for only 12 of the 41 antibiotics queried – a matching rate of just 29%.

For the other 29 antibiotics, ChatGPT either “incorrectly reported that there was an FDA boxed warning when there was not, or inaccurately or incorrectly reported the boxed warning,” Rebecca Linfield, MD, infectious diseases fellow, Stanford (Calif.) University, said in an interview.
 

Uncritical AI use risky

Nine of the 41 antibiotics included in the query have boxed warnings. And ChatGPT correctly identified all nine, but only three were the matching adverse event (33%). For the 32 antibiotics without an FDA boxed warning, ChatGPT correctly reported that 28% (9 of 32) do not have a boxed warning.

For example, ChatGPT stated that the antibiotic fidaxomicin has a boxed warning for increased risk for Clostridioides difficile, “but it is the first-line antibiotic used to treat C. difficile,” Dr. Linfield pointed out.

ChatGPT also reported that cefepime increased the risk for death in those with pneumonia and fabricated a study supporting that assertion. “However, cefepime is a first-line drug for those with hospital-acquired pneumonia,” Dr. Linfield explained.

“I can imagine a worried family member finding this through ChatGPT, and needing to have extensive reassurances from the patient’s physicians about why this antibiotic was chosen,” she said.

ChatGPT also incorrectly stated that aztreonam has a boxed warning for increased mortality.

“The risk is that both physicians and the public uncritically use ChatGPT as an easily accessible, readable source of clinically validated information, when these large language models are meant to generate fluid text, and not necessarily accurate information,” Dr. Linfield told this news organization.

Dr. Linfield said that the next step is to compare the ChatGPT 3.5 used in this analysis with ChatGPT 4, as well as with Google’s Med-PaLM 2 after it is released to the public.
 

Advancing fast

At plenary, Dr. Kohane pointed out that AI is a quick learner and improvements in tools are coming fast.

As an example, just 3 years ago, the best AI tool could score about as well as the worst student taking the medical boards, he told the audience. “Three years later, the leading large language models are scoring better than 90% of all the candidates. What’s it going to be doing next year?” he asked.

“I don’t know,” Dr. Kohane said, “but it will be better than this year.” AI will “transform health care.”

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

Artificial intelligence (AI) models are typically a year out of date and have this “charming problem of hallucinating made-up data and saying it with all the certainty of an attending on rounds,” Isaac Kohane, MD, PhD, Harvard Medical School, Boston, told a packed audience at plenary at an annual scientific meeting on infectious diseases.

Dr. Kohane, chair of the department of biomedical informatics, says the future intersection between AI and health care is “muddy.”

Echoing questions about the accuracy of new AI tools, researchers at the meeting presented the results of their new test of ChatGPT.

The AI chatbot is designed for language processing – not scientific accuracy – and does not guarantee that responses to medical queries are fully factual.

To test the accuracy of ChatGPT’s version 3.5, the researchers asked it if there are any boxed warnings on the U.S. Food and Drug Administration’s label for common antibiotics, and if so, what they are.

ChatGPT provided correct answers about FDA boxed warnings for only 12 of the 41 antibiotics queried – a matching rate of just 29%.

For the other 29 antibiotics, ChatGPT either “incorrectly reported that there was an FDA boxed warning when there was not, or inaccurately or incorrectly reported the boxed warning,” Rebecca Linfield, MD, infectious diseases fellow, Stanford (Calif.) University, said in an interview.
 

Uncritical AI use risky

Nine of the 41 antibiotics included in the query have boxed warnings. And ChatGPT correctly identified all nine, but only three were the matching adverse event (33%). For the 32 antibiotics without an FDA boxed warning, ChatGPT correctly reported that 28% (9 of 32) do not have a boxed warning.

For example, ChatGPT stated that the antibiotic fidaxomicin has a boxed warning for increased risk for Clostridioides difficile, “but it is the first-line antibiotic used to treat C. difficile,” Dr. Linfield pointed out.

ChatGPT also reported that cefepime increased the risk for death in those with pneumonia and fabricated a study supporting that assertion. “However, cefepime is a first-line drug for those with hospital-acquired pneumonia,” Dr. Linfield explained.

“I can imagine a worried family member finding this through ChatGPT, and needing to have extensive reassurances from the patient’s physicians about why this antibiotic was chosen,” she said.

ChatGPT also incorrectly stated that aztreonam has a boxed warning for increased mortality.

“The risk is that both physicians and the public uncritically use ChatGPT as an easily accessible, readable source of clinically validated information, when these large language models are meant to generate fluid text, and not necessarily accurate information,” Dr. Linfield told this news organization.

Dr. Linfield said that the next step is to compare the ChatGPT 3.5 used in this analysis with ChatGPT 4, as well as with Google’s Med-PaLM 2 after it is released to the public.
 

Advancing fast

At plenary, Dr. Kohane pointed out that AI is a quick learner and improvements in tools are coming fast.

As an example, just 3 years ago, the best AI tool could score about as well as the worst student taking the medical boards, he told the audience. “Three years later, the leading large language models are scoring better than 90% of all the candidates. What’s it going to be doing next year?” he asked.

“I don’t know,” Dr. Kohane said, “but it will be better than this year.” AI will “transform health care.”

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

New England Baptist Hospital has been grappling with a serious problem facing health care today: insurers demanding prior authorizations for services ordered by physicians. Meeting payers’ requirements eats up time, delays treatment, and can be a costly drain on doctors’ practices. 

To deal with this problem, the Boston orthopedic hospital has opted to automate submission of prior authorization requests on behalf of more than 100 mostly orthopedic surgeons on staff. 

After 5 years using this system, “we can say that automation definitely works,” said Lidiya Hadzhieva, director of patient access at the hospital. The software has reduced write-offs by 30% and staff costs by 25%. Prior authorization gets approved 3 days after scheduling, compared with 11 days previously, she said.

“This software not only saves staff time, but it can also more accurately predict when prior authorization is needed,” she added.

For practices deluged with required prior authorizations by insurers, automation is emerging as a way for practices to make the process less time-consuming and save money. However, the software can be costly and may not be adoptable to many practices, and many physicians are not even aware it exists.

So far, the software is mainly used at large organizations like hospital systems. But as word gets out and the software becomes easier to use, private practices and other smaller entities may join the automation trend.

There is definitely a need to automate prior authorization. The American Medical Association reports that physicians spend 16 hours per week on prior authorizations. In a recent AMA survey, more than 60% of physicians indicated that it’s difficult to know when prior authorization is needed. And 93% of physicians reported care delays while waiting for authorization, the AMA said.  

Experts estimate that 80% of prior authorization work could be automated, but most practices still use the phone or fax, even as numbers of prior authorizations continue to increase.
 

How it works

Automation software connects directly to the practice’s electronic health record (EHR). “When the doctor places an order in the EHR, the process starts automatically,” Ms. Hadzhieva said. “The doctor may not even notice it.” 

In addition to using an EHR connection, many software products can communicate with the payer through its portal or by fax or phone, while still automating other parts of the process.

The software’s first step is to decide whether prior authorization is needed. This requires having an updated list of the rules that each payer uses for prior authorization. Manually keeping track of payer rules is very time-consuming, but automation uses bots to visit each payer site to look for rules changes. One vendor, Infinitus, uses a voice-based bot called Eva that calls up each payer and speaks with a representative.

“Automatically updating payer rules is not a new technology,” said YiDing Yu, MD, chief product officer at Olive, the automation vendor for New England Baptist. “What is new in the last 5 years is extracting the information needed for the prior authorization out of the clinical notes.”

This is challenging because each doctor has different ways to describe each step of clinical work. To identify this shorthand, Dr. Yu said Olive uses natural language processing, which is a form of artificial intelligence that learns how each doctor describes things.

Dr. Yu asserts that Olive is actually better than a practice’s staff at digging out clinical information. She said staff without much clinical training may miss terms that the software can catch, and they don’t have the time to go back many months into the record to find valuable information. But automation can do that.

In some instances, however, the software may not be able to find the information, in which case it alerts staff through a prompt in the EHR and the information is retrieved manually, Dr. Yu said.

Next, the Olive software puts the information it found into the request form and sends it to the payer. After submission, the software constantly checks on the status of each request, again visiting payer sites with a bot.

At New England Baptist, the software is used mainly by physicians in fairly small private practices who are on staff. They are using the software on the hospital’s dime, but it only works inside the hospital, Ms. Hadzhieva said. For their work outside of the hospital, they would have to purchase the Olive software on their own, she said.
 

Automation hasn’t spread to practices yet

Despite the promising outcomes for products like Olive, automation software is still primarily used by large organizations. Vendors say very few private practices have bought it yet. “The technology works, but it is still in the early-adopter phase,” Dr. Yu said.

For one thing, the software can be expensive. Very few vendors reveal their prices, but Dr. Yu did so. She said Olive normally costs about $50,000 a year for even a small organization. She insisted, however, that the savings from avoiding just one denial each month for a hip surgery would justify the expense.

On the other hand, some automation software is free, such as the Surescripts product for prior authorization of prescriptions. But it is unclear whether Surescripts does as much as Olive. Vendors’ descriptions of their products tend to be vague.

Also, Surescripts and Olive have entirely separate functions. Dr. Yu said Olive is limited to procedures, so it benefits specialties like oncology, neurosurgery, colorectal surgery, vascular surgery, and cardiology. Olive does not cover prescriptions, because they operate on a different technology.

Dr. Yu said another hurdle for adopting the software is the kind of EHR systems that doctors use. At this point, only a few EHR systems – such as Epic, Cerner, and Athena – are compatible with Olive. Large organizations tend to use Epic and Cerner, while many practices often use Athena or a variety of other systems, she said.

Despite stunted demand, there is no shortage of companies offering automation software for medical (that is, non-prescription) prior authorization. One compilation lists 25 such vendors, including companies like Myndshft, Rhyme, Infinitus, Infinx, and Waystar. As with any start-up technology, companies occasionally buy each other out.

In addition to issues like cost, specialty, and EHR compatibility, another hurdle is that few doctors even know the technology exists. Vendors say marketing focuses on larger provider organizations, not smaller practices.

Even many tech-savvy doctors, like Adam Bruggeman, MD, an orthopedist and CEO of Texas Spine Care Center in San Antonio, say they know little about the technology. “There is definitely a need to automate prior authorization,” he said. “But I don’t know of any colleagues who use it.” He has only just begun to explore vendors, he said.

Many medical practice consultants also have not yet explored the technology. “Automation makes a lot of sense, because there are a lot of repetitive tasks in prior authorization,” said Jill Arena, CEO of Portland, Ore.–based Health e Practices. “But I haven’t looked into it yet, and none of my clients has even asked about it.”

“I could see how it could be an easier sell for large organizations,” she added. “They have an IT person and a CFO who can explore the issue. Smaller practices usually don’t have that kind of expertise.”
 

Where does automation go from here?

Until now, clinicians who want to fully automate prior authorizations would have to buy two products – one for medical procedures and one for prescriptions. This has to do with incompatible electronic transmission standards, which are used to digitize information, said Susan Lawson-Dawson, content marketing strategist for the vendor Myndshft Health.

Myndshft has long been selling automation software for medical prior authorizations, but now it is introducing a product for prescriptions, Ms. Lawson-Dawson said. She said Myndshft will then be the only vendor to automate both kinds of prior authorizations.

Ms. Lawson-Dawson said Myndshft has 685 customers to date and is looking for more business. Recently the company entered the Google Cloud Marketplace. Google Cloud customers can now direct their committed spend with Google to purchasing Myndshft, meaning they could get it at a discount.

Software like Olive and Myndshft can operate independently of payers, but a vendor called Rhyme depends on payers for its software to function, said Rhyme CEO Joe Anstine. He said more than 300 payers have agreed to install the Rhyme system, and Rhyme has signed up a number of large health systems to use the product. Initially, he said, clinicians paid for the service, but now Rhyme is beginning to find payers to foot the costs and to let clinicians use it for free, which would open Rhyme up to smaller practices.

EHR companies themselves are beginning to offer automation, too. Epic, for example, has created a tool for prior authorization as part of its Epic Payer Platform. Like Rhyme, it requires payer cooperation, because information goes back and forth between clinician and payer in what is called bi-directional exchange.

The Epic product is still in its pilot phase. Epic reported that several large health systems were using its product in conjunction with a specific payer – for instance, Mayo Clinic with Blue Cross and Blue Shield of Minnesota and Ochsner Health with Humana. According to Epic, the arrangement reduced Mayo’s denials due to additional documentation requests by 63% for professional billing.

Automating with just one payer still means the clinician has to deal with manual processes at other payers, but a large clinician could have sufficient volume with that one payer to make the arrangement useful.
 

Will payers automate prior authorization?

Ultimately, payers may take the automation business away from vendors, offering a free product to all clinicians. But don’t hold your breath. Payers first have to rebuild their electronic systems to accommodate an electronic connection with providers. Even then, some payers might hold back from automating, forcing practices to continue manually processing some prior authorizations.

Efforts are underway, however, to mandate payers to support prior authorization automation. For this to happen, payers would have to revamp their data so that it could be easily read by practices’ EHRs. This would mean adopting a specific interoperability standard called Health Level 7 Fast Healthcare Interoperability Resources (FHIR).

Toward this goal, the Centers for Medicare & Medicaid Services proposes to require payers to adopt FHIR by January 2026. (CMS still has to finalize the rule.) Experts say the two-year ramp-up time is needed because it takes extensive work for payers to translate their data into FHIR.

The only payer so far to switch to FHIR for prior authorization is Regence in Washington state. In a pilot project, it has automated prior authorization with just one provider, MultiCare Connected Care, an accountable care organization (ACO), also in Washington state.

Anna Taylor, associate vice president of population health and value-based care at MultiCare, explained how the arrangement works. “Two separate entities are sharing one operational process,” she told this news organization. “That means they can have a digital conversation back and forth, so it is much easier to resolve prior authorization issues.” 

Unlike many vendor products, the Regence service is free. And while the vendors market only to large organizations, most doctors in the MultiCare arrangement are in independent practices. Ms. Taylor said these doctors have been “enthusiastic” about the arrangement.

The results of the pilot are impressive. Ms. Taylor said automation has resulted in a 233% productivity gain for MultiCare clinicians, and 89% of submissions to Regence get an immediate response.

There is a potential downside, however, to working directly with payers. A direct connection to clinicians allows payers to access the doctor’s clinical notes, which could make many doctors uneasy. But Ms. Taylor said Regence only has access to the “discrete data fields” on MultiCare’s EHR dashboard, not to the notes themselves.

The ultimate goal of the Regence-Multicare project is to include more payers and clinicians. Ms. Taylor said two of the 27 other payers that MultiCare works with are “highly interested,” but it would take a lot of work for them to get connected with practices and other clinicians. 

Ultimately, payers could offer automation and third-party vendors might then fade away. However, physicians may resist working directly with payers if the arrangement requires full access to their medical records.

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

New England Baptist Hospital has been grappling with a serious problem facing health care today: insurers demanding prior authorizations for services ordered by physicians. Meeting payers’ requirements eats up time, delays treatment, and can be a costly drain on doctors’ practices. 

To deal with this problem, the Boston orthopedic hospital has opted to automate submission of prior authorization requests on behalf of more than 100 mostly orthopedic surgeons on staff. 

After 5 years using this system, “we can say that automation definitely works,” said Lidiya Hadzhieva, director of patient access at the hospital. The software has reduced write-offs by 30% and staff costs by 25%. Prior authorization gets approved 3 days after scheduling, compared with 11 days previously, she said.

“This software not only saves staff time, but it can also more accurately predict when prior authorization is needed,” she added.

For practices deluged with required prior authorizations by insurers, automation is emerging as a way for practices to make the process less time-consuming and save money. However, the software can be costly and may not be adoptable to many practices, and many physicians are not even aware it exists.

So far, the software is mainly used at large organizations like hospital systems. But as word gets out and the software becomes easier to use, private practices and other smaller entities may join the automation trend.

There is definitely a need to automate prior authorization. The American Medical Association reports that physicians spend 16 hours per week on prior authorizations. In a recent AMA survey, more than 60% of physicians indicated that it’s difficult to know when prior authorization is needed. And 93% of physicians reported care delays while waiting for authorization, the AMA said.  

Experts estimate that 80% of prior authorization work could be automated, but most practices still use the phone or fax, even as numbers of prior authorizations continue to increase.
 

How it works

Automation software connects directly to the practice’s electronic health record (EHR). “When the doctor places an order in the EHR, the process starts automatically,” Ms. Hadzhieva said. “The doctor may not even notice it.” 

In addition to using an EHR connection, many software products can communicate with the payer through its portal or by fax or phone, while still automating other parts of the process.

The software’s first step is to decide whether prior authorization is needed. This requires having an updated list of the rules that each payer uses for prior authorization. Manually keeping track of payer rules is very time-consuming, but automation uses bots to visit each payer site to look for rules changes. One vendor, Infinitus, uses a voice-based bot called Eva that calls up each payer and speaks with a representative.

“Automatically updating payer rules is not a new technology,” said YiDing Yu, MD, chief product officer at Olive, the automation vendor for New England Baptist. “What is new in the last 5 years is extracting the information needed for the prior authorization out of the clinical notes.”

This is challenging because each doctor has different ways to describe each step of clinical work. To identify this shorthand, Dr. Yu said Olive uses natural language processing, which is a form of artificial intelligence that learns how each doctor describes things.

Dr. Yu asserts that Olive is actually better than a practice’s staff at digging out clinical information. She said staff without much clinical training may miss terms that the software can catch, and they don’t have the time to go back many months into the record to find valuable information. But automation can do that.

In some instances, however, the software may not be able to find the information, in which case it alerts staff through a prompt in the EHR and the information is retrieved manually, Dr. Yu said.

Next, the Olive software puts the information it found into the request form and sends it to the payer. After submission, the software constantly checks on the status of each request, again visiting payer sites with a bot.

At New England Baptist, the software is used mainly by physicians in fairly small private practices who are on staff. They are using the software on the hospital’s dime, but it only works inside the hospital, Ms. Hadzhieva said. For their work outside of the hospital, they would have to purchase the Olive software on their own, she said.
 

Automation hasn’t spread to practices yet

Despite the promising outcomes for products like Olive, automation software is still primarily used by large organizations. Vendors say very few private practices have bought it yet. “The technology works, but it is still in the early-adopter phase,” Dr. Yu said.

For one thing, the software can be expensive. Very few vendors reveal their prices, but Dr. Yu did so. She said Olive normally costs about $50,000 a year for even a small organization. She insisted, however, that the savings from avoiding just one denial each month for a hip surgery would justify the expense.

On the other hand, some automation software is free, such as the Surescripts product for prior authorization of prescriptions. But it is unclear whether Surescripts does as much as Olive. Vendors’ descriptions of their products tend to be vague.

Also, Surescripts and Olive have entirely separate functions. Dr. Yu said Olive is limited to procedures, so it benefits specialties like oncology, neurosurgery, colorectal surgery, vascular surgery, and cardiology. Olive does not cover prescriptions, because they operate on a different technology.

Dr. Yu said another hurdle for adopting the software is the kind of EHR systems that doctors use. At this point, only a few EHR systems – such as Epic, Cerner, and Athena – are compatible with Olive. Large organizations tend to use Epic and Cerner, while many practices often use Athena or a variety of other systems, she said.

Despite stunted demand, there is no shortage of companies offering automation software for medical (that is, non-prescription) prior authorization. One compilation lists 25 such vendors, including companies like Myndshft, Rhyme, Infinitus, Infinx, and Waystar. As with any start-up technology, companies occasionally buy each other out.

In addition to issues like cost, specialty, and EHR compatibility, another hurdle is that few doctors even know the technology exists. Vendors say marketing focuses on larger provider organizations, not smaller practices.

Even many tech-savvy doctors, like Adam Bruggeman, MD, an orthopedist and CEO of Texas Spine Care Center in San Antonio, say they know little about the technology. “There is definitely a need to automate prior authorization,” he said. “But I don’t know of any colleagues who use it.” He has only just begun to explore vendors, he said.

Many medical practice consultants also have not yet explored the technology. “Automation makes a lot of sense, because there are a lot of repetitive tasks in prior authorization,” said Jill Arena, CEO of Portland, Ore.–based Health e Practices. “But I haven’t looked into it yet, and none of my clients has even asked about it.”

“I could see how it could be an easier sell for large organizations,” she added. “They have an IT person and a CFO who can explore the issue. Smaller practices usually don’t have that kind of expertise.”
 

Where does automation go from here?

Until now, clinicians who want to fully automate prior authorizations would have to buy two products – one for medical procedures and one for prescriptions. This has to do with incompatible electronic transmission standards, which are used to digitize information, said Susan Lawson-Dawson, content marketing strategist for the vendor Myndshft Health.

Myndshft has long been selling automation software for medical prior authorizations, but now it is introducing a product for prescriptions, Ms. Lawson-Dawson said. She said Myndshft will then be the only vendor to automate both kinds of prior authorizations.

Ms. Lawson-Dawson said Myndshft has 685 customers to date and is looking for more business. Recently the company entered the Google Cloud Marketplace. Google Cloud customers can now direct their committed spend with Google to purchasing Myndshft, meaning they could get it at a discount.

Software like Olive and Myndshft can operate independently of payers, but a vendor called Rhyme depends on payers for its software to function, said Rhyme CEO Joe Anstine. He said more than 300 payers have agreed to install the Rhyme system, and Rhyme has signed up a number of large health systems to use the product. Initially, he said, clinicians paid for the service, but now Rhyme is beginning to find payers to foot the costs and to let clinicians use it for free, which would open Rhyme up to smaller practices.

EHR companies themselves are beginning to offer automation, too. Epic, for example, has created a tool for prior authorization as part of its Epic Payer Platform. Like Rhyme, it requires payer cooperation, because information goes back and forth between clinician and payer in what is called bi-directional exchange.

The Epic product is still in its pilot phase. Epic reported that several large health systems were using its product in conjunction with a specific payer – for instance, Mayo Clinic with Blue Cross and Blue Shield of Minnesota and Ochsner Health with Humana. According to Epic, the arrangement reduced Mayo’s denials due to additional documentation requests by 63% for professional billing.

Automating with just one payer still means the clinician has to deal with manual processes at other payers, but a large clinician could have sufficient volume with that one payer to make the arrangement useful.
 

Will payers automate prior authorization?

Ultimately, payers may take the automation business away from vendors, offering a free product to all clinicians. But don’t hold your breath. Payers first have to rebuild their electronic systems to accommodate an electronic connection with providers. Even then, some payers might hold back from automating, forcing practices to continue manually processing some prior authorizations.

Efforts are underway, however, to mandate payers to support prior authorization automation. For this to happen, payers would have to revamp their data so that it could be easily read by practices’ EHRs. This would mean adopting a specific interoperability standard called Health Level 7 Fast Healthcare Interoperability Resources (FHIR).

Toward this goal, the Centers for Medicare & Medicaid Services proposes to require payers to adopt FHIR by January 2026. (CMS still has to finalize the rule.) Experts say the two-year ramp-up time is needed because it takes extensive work for payers to translate their data into FHIR.

The only payer so far to switch to FHIR for prior authorization is Regence in Washington state. In a pilot project, it has automated prior authorization with just one provider, MultiCare Connected Care, an accountable care organization (ACO), also in Washington state.

Anna Taylor, associate vice president of population health and value-based care at MultiCare, explained how the arrangement works. “Two separate entities are sharing one operational process,” she told this news organization. “That means they can have a digital conversation back and forth, so it is much easier to resolve prior authorization issues.” 

Unlike many vendor products, the Regence service is free. And while the vendors market only to large organizations, most doctors in the MultiCare arrangement are in independent practices. Ms. Taylor said these doctors have been “enthusiastic” about the arrangement.

The results of the pilot are impressive. Ms. Taylor said automation has resulted in a 233% productivity gain for MultiCare clinicians, and 89% of submissions to Regence get an immediate response.

There is a potential downside, however, to working directly with payers. A direct connection to clinicians allows payers to access the doctor’s clinical notes, which could make many doctors uneasy. But Ms. Taylor said Regence only has access to the “discrete data fields” on MultiCare’s EHR dashboard, not to the notes themselves.

The ultimate goal of the Regence-Multicare project is to include more payers and clinicians. Ms. Taylor said two of the 27 other payers that MultiCare works with are “highly interested,” but it would take a lot of work for them to get connected with practices and other clinicians. 

Ultimately, payers could offer automation and third-party vendors might then fade away. However, physicians may resist working directly with payers if the arrangement requires full access to their medical records.

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

New England Baptist Hospital has been grappling with a serious problem facing health care today: insurers demanding prior authorizations for services ordered by physicians. Meeting payers’ requirements eats up time, delays treatment, and can be a costly drain on doctors’ practices. 

To deal with this problem, the Boston orthopedic hospital has opted to automate submission of prior authorization requests on behalf of more than 100 mostly orthopedic surgeons on staff. 

After 5 years using this system, “we can say that automation definitely works,” said Lidiya Hadzhieva, director of patient access at the hospital. The software has reduced write-offs by 30% and staff costs by 25%. Prior authorization gets approved 3 days after scheduling, compared with 11 days previously, she said.

“This software not only saves staff time, but it can also more accurately predict when prior authorization is needed,” she added.

For practices deluged with required prior authorizations by insurers, automation is emerging as a way for practices to make the process less time-consuming and save money. However, the software can be costly and may not be adoptable to many practices, and many physicians are not even aware it exists.

So far, the software is mainly used at large organizations like hospital systems. But as word gets out and the software becomes easier to use, private practices and other smaller entities may join the automation trend.

There is definitely a need to automate prior authorization. The American Medical Association reports that physicians spend 16 hours per week on prior authorizations. In a recent AMA survey, more than 60% of physicians indicated that it’s difficult to know when prior authorization is needed. And 93% of physicians reported care delays while waiting for authorization, the AMA said.  

Experts estimate that 80% of prior authorization work could be automated, but most practices still use the phone or fax, even as numbers of prior authorizations continue to increase.
 

How it works

Automation software connects directly to the practice’s electronic health record (EHR). “When the doctor places an order in the EHR, the process starts automatically,” Ms. Hadzhieva said. “The doctor may not even notice it.” 

In addition to using an EHR connection, many software products can communicate with the payer through its portal or by fax or phone, while still automating other parts of the process.

The software’s first step is to decide whether prior authorization is needed. This requires having an updated list of the rules that each payer uses for prior authorization. Manually keeping track of payer rules is very time-consuming, but automation uses bots to visit each payer site to look for rules changes. One vendor, Infinitus, uses a voice-based bot called Eva that calls up each payer and speaks with a representative.

“Automatically updating payer rules is not a new technology,” said YiDing Yu, MD, chief product officer at Olive, the automation vendor for New England Baptist. “What is new in the last 5 years is extracting the information needed for the prior authorization out of the clinical notes.”

This is challenging because each doctor has different ways to describe each step of clinical work. To identify this shorthand, Dr. Yu said Olive uses natural language processing, which is a form of artificial intelligence that learns how each doctor describes things.

Dr. Yu asserts that Olive is actually better than a practice’s staff at digging out clinical information. She said staff without much clinical training may miss terms that the software can catch, and they don’t have the time to go back many months into the record to find valuable information. But automation can do that.

In some instances, however, the software may not be able to find the information, in which case it alerts staff through a prompt in the EHR and the information is retrieved manually, Dr. Yu said.

Next, the Olive software puts the information it found into the request form and sends it to the payer. After submission, the software constantly checks on the status of each request, again visiting payer sites with a bot.

At New England Baptist, the software is used mainly by physicians in fairly small private practices who are on staff. They are using the software on the hospital’s dime, but it only works inside the hospital, Ms. Hadzhieva said. For their work outside of the hospital, they would have to purchase the Olive software on their own, she said.
 

Automation hasn’t spread to practices yet

Despite the promising outcomes for products like Olive, automation software is still primarily used by large organizations. Vendors say very few private practices have bought it yet. “The technology works, but it is still in the early-adopter phase,” Dr. Yu said.

For one thing, the software can be expensive. Very few vendors reveal their prices, but Dr. Yu did so. She said Olive normally costs about $50,000 a year for even a small organization. She insisted, however, that the savings from avoiding just one denial each month for a hip surgery would justify the expense.

On the other hand, some automation software is free, such as the Surescripts product for prior authorization of prescriptions. But it is unclear whether Surescripts does as much as Olive. Vendors’ descriptions of their products tend to be vague.

Also, Surescripts and Olive have entirely separate functions. Dr. Yu said Olive is limited to procedures, so it benefits specialties like oncology, neurosurgery, colorectal surgery, vascular surgery, and cardiology. Olive does not cover prescriptions, because they operate on a different technology.

Dr. Yu said another hurdle for adopting the software is the kind of EHR systems that doctors use. At this point, only a few EHR systems – such as Epic, Cerner, and Athena – are compatible with Olive. Large organizations tend to use Epic and Cerner, while many practices often use Athena or a variety of other systems, she said.

Despite stunted demand, there is no shortage of companies offering automation software for medical (that is, non-prescription) prior authorization. One compilation lists 25 such vendors, including companies like Myndshft, Rhyme, Infinitus, Infinx, and Waystar. As with any start-up technology, companies occasionally buy each other out.

In addition to issues like cost, specialty, and EHR compatibility, another hurdle is that few doctors even know the technology exists. Vendors say marketing focuses on larger provider organizations, not smaller practices.

Even many tech-savvy doctors, like Adam Bruggeman, MD, an orthopedist and CEO of Texas Spine Care Center in San Antonio, say they know little about the technology. “There is definitely a need to automate prior authorization,” he said. “But I don’t know of any colleagues who use it.” He has only just begun to explore vendors, he said.

Many medical practice consultants also have not yet explored the technology. “Automation makes a lot of sense, because there are a lot of repetitive tasks in prior authorization,” said Jill Arena, CEO of Portland, Ore.–based Health e Practices. “But I haven’t looked into it yet, and none of my clients has even asked about it.”

“I could see how it could be an easier sell for large organizations,” she added. “They have an IT person and a CFO who can explore the issue. Smaller practices usually don’t have that kind of expertise.”
 

Where does automation go from here?

Until now, clinicians who want to fully automate prior authorizations would have to buy two products – one for medical procedures and one for prescriptions. This has to do with incompatible electronic transmission standards, which are used to digitize information, said Susan Lawson-Dawson, content marketing strategist for the vendor Myndshft Health.

Myndshft has long been selling automation software for medical prior authorizations, but now it is introducing a product for prescriptions, Ms. Lawson-Dawson said. She said Myndshft will then be the only vendor to automate both kinds of prior authorizations.

Ms. Lawson-Dawson said Myndshft has 685 customers to date and is looking for more business. Recently the company entered the Google Cloud Marketplace. Google Cloud customers can now direct their committed spend with Google to purchasing Myndshft, meaning they could get it at a discount.

Software like Olive and Myndshft can operate independently of payers, but a vendor called Rhyme depends on payers for its software to function, said Rhyme CEO Joe Anstine. He said more than 300 payers have agreed to install the Rhyme system, and Rhyme has signed up a number of large health systems to use the product. Initially, he said, clinicians paid for the service, but now Rhyme is beginning to find payers to foot the costs and to let clinicians use it for free, which would open Rhyme up to smaller practices.

EHR companies themselves are beginning to offer automation, too. Epic, for example, has created a tool for prior authorization as part of its Epic Payer Platform. Like Rhyme, it requires payer cooperation, because information goes back and forth between clinician and payer in what is called bi-directional exchange.

The Epic product is still in its pilot phase. Epic reported that several large health systems were using its product in conjunction with a specific payer – for instance, Mayo Clinic with Blue Cross and Blue Shield of Minnesota and Ochsner Health with Humana. According to Epic, the arrangement reduced Mayo’s denials due to additional documentation requests by 63% for professional billing.

Automating with just one payer still means the clinician has to deal with manual processes at other payers, but a large clinician could have sufficient volume with that one payer to make the arrangement useful.
 

Will payers automate prior authorization?

Ultimately, payers may take the automation business away from vendors, offering a free product to all clinicians. But don’t hold your breath. Payers first have to rebuild their electronic systems to accommodate an electronic connection with providers. Even then, some payers might hold back from automating, forcing practices to continue manually processing some prior authorizations.

Efforts are underway, however, to mandate payers to support prior authorization automation. For this to happen, payers would have to revamp their data so that it could be easily read by practices’ EHRs. This would mean adopting a specific interoperability standard called Health Level 7 Fast Healthcare Interoperability Resources (FHIR).

Toward this goal, the Centers for Medicare & Medicaid Services proposes to require payers to adopt FHIR by January 2026. (CMS still has to finalize the rule.) Experts say the two-year ramp-up time is needed because it takes extensive work for payers to translate their data into FHIR.

The only payer so far to switch to FHIR for prior authorization is Regence in Washington state. In a pilot project, it has automated prior authorization with just one provider, MultiCare Connected Care, an accountable care organization (ACO), also in Washington state.

Anna Taylor, associate vice president of population health and value-based care at MultiCare, explained how the arrangement works. “Two separate entities are sharing one operational process,” she told this news organization. “That means they can have a digital conversation back and forth, so it is much easier to resolve prior authorization issues.” 

Unlike many vendor products, the Regence service is free. And while the vendors market only to large organizations, most doctors in the MultiCare arrangement are in independent practices. Ms. Taylor said these doctors have been “enthusiastic” about the arrangement.

The results of the pilot are impressive. Ms. Taylor said automation has resulted in a 233% productivity gain for MultiCare clinicians, and 89% of submissions to Regence get an immediate response.

There is a potential downside, however, to working directly with payers. A direct connection to clinicians allows payers to access the doctor’s clinical notes, which could make many doctors uneasy. But Ms. Taylor said Regence only has access to the “discrete data fields” on MultiCare’s EHR dashboard, not to the notes themselves.

The ultimate goal of the Regence-Multicare project is to include more payers and clinicians. Ms. Taylor said two of the 27 other payers that MultiCare works with are “highly interested,” but it would take a lot of work for them to get connected with practices and other clinicians. 

Ultimately, payers could offer automation and third-party vendors might then fade away. However, physicians may resist working directly with payers if the arrangement requires full access to their medical records.

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

I’m speaking today about the ever-rising prominence of neoadjuvant therapy for patients with locally advanced lung cancers. There are more and more data emerging suggesting that the neoadjuvant strategy is a better one.

Many of you saw the press release from Merck announcing that their randomized trial comparing chemo with chemo plus pembrolizumab in the neoadjuvant setting led to improved event-free survival and also improved pathologic complete response rate.

This comes in addition to the data from the AstraZeneca trial with durvalumab saying they’ve already achieved their endpoint of higher pathologic complete response rate vs. chemotherapy alone and also the data with nivolumab from Bristol-Myers Squibb saying that nivolumab plus chemotherapy leads to a better event-free survival and a better pathologic complete response rate. That information has led to Food and Drug Administration approval for their regimen.

We’re running the table with these very positive data, and I think it’s just a sign that the approach is safe and effective.

A huge question has come up. I just came from a meeting of lung cancer experts asking what to do if you have a patient with a small tumor, for example, a 3-cm tumor. Do you recommend immediate surgery followed by adjuvant therapy, chemotherapy, and then a checkpoint inhibitor if appropriate? Or do you proceed with neoadjuvant therapy if appropriate? The truth is that it’s a very difficult decision.

We have overwhelming data that the neoadjuvant approach works for that patient. Please remember that this is a clinically staged patient. This is not the patient after their surgery, where I think we have a very clear path. We have adjuvant data and adjuvant trials for those patients.

For the patient who’s in your office with a small tumor or a small tumor and only hilar lymphadenopathy, the decision there isn’t data driven, but rather it is experience driven. The data that are out there right now suggest that neoadjuvant therapy is a better way to go. Why is that?

Well, I think that the first reason is that it is probably a better regimen. I think many of you saw the recent clinical trial by Patel and colleagues in the New England Journal of Medicine with melanoma. It was an interesting trial. They gave a checkpoint inhibitor for 18 doses after surgery for melanoma versus three doses of checkpoint inhibitor, surgery, and then 15 doses of the checkpoint inhibitor.

It was 18 doses versus 18 doses, with the only difference being the three doses before surgery. Lo and behold, the three doses before surgery led to a better event-free survival.

There are preclinical data in lung cancer demonstrating that the same thing is true. Tina Cascone published on that years ago. We could talk about why, but it appears that neoadjuvant is just better.

There are other advantages to it as well. I think a big one is that all the information shows that it’s better tolerated, so you’re more likely to give all the drug. You can see if the drug isn’t working, and you can stop the drug. Also, if the drug is causing a side effect, you can see whether it’s working or not and use that decision to stop. It’s different than when you’re giving a drug in the adjuvant setting where you don’t really know whether it is working or not.

I think that it’s time to change some of our standards. When patients appear with lung cancers other than tiny ones that might be detected through screening, you need to convene your multidisciplinary group. You need to weigh the pros and cons I think that it’s time to change some of our standards. When patients appear with lung cancers other than tiny ones that might be detected through screening, you need to convene your multidisciplinary group coming in. It’s already an FDA-approved regimen with nivolumab and chemotherapy, and I think we’re moving to making that our standard of care now.

The way to handle it today, though, is to convene your multidisciplinary panel about every patient other than those with the tiniest of lung cancers and put your heads together to see what the best treatment is for that patient.

Dr. Kris is professor of medicine, Weill Cornell Medicine, and the William and Joy Ruane Chair in Thoracic Oncology, Memorial Sloan Kettering Cancer Center, both in New York. He disclosed ties with Ariad Pharmaceuticals, AstraZeneca, Pfizer, PUMA, and Roche/Genentech.

A version of this article appeared on Medscape.com.

I’m speaking today about the ever-rising prominence of neoadjuvant therapy for patients with locally advanced lung cancers. There are more and more data emerging suggesting that the neoadjuvant strategy is a better one.

Many of you saw the press release from Merck announcing that their randomized trial comparing chemo with chemo plus pembrolizumab in the neoadjuvant setting led to improved event-free survival and also improved pathologic complete response rate.

This comes in addition to the data from the AstraZeneca trial with durvalumab saying they’ve already achieved their endpoint of higher pathologic complete response rate vs. chemotherapy alone and also the data with nivolumab from Bristol-Myers Squibb saying that nivolumab plus chemotherapy leads to a better event-free survival and a better pathologic complete response rate. That information has led to Food and Drug Administration approval for their regimen.

We’re running the table with these very positive data, and I think it’s just a sign that the approach is safe and effective.

A huge question has come up. I just came from a meeting of lung cancer experts asking what to do if you have a patient with a small tumor, for example, a 3-cm tumor. Do you recommend immediate surgery followed by adjuvant therapy, chemotherapy, and then a checkpoint inhibitor if appropriate? Or do you proceed with neoadjuvant therapy if appropriate? The truth is that it’s a very difficult decision.

We have overwhelming data that the neoadjuvant approach works for that patient. Please remember that this is a clinically staged patient. This is not the patient after their surgery, where I think we have a very clear path. We have adjuvant data and adjuvant trials for those patients.

For the patient who’s in your office with a small tumor or a small tumor and only hilar lymphadenopathy, the decision there isn’t data driven, but rather it is experience driven. The data that are out there right now suggest that neoadjuvant therapy is a better way to go. Why is that?

Well, I think that the first reason is that it is probably a better regimen. I think many of you saw the recent clinical trial by Patel and colleagues in the New England Journal of Medicine with melanoma. It was an interesting trial. They gave a checkpoint inhibitor for 18 doses after surgery for melanoma versus three doses of checkpoint inhibitor, surgery, and then 15 doses of the checkpoint inhibitor.

It was 18 doses versus 18 doses, with the only difference being the three doses before surgery. Lo and behold, the three doses before surgery led to a better event-free survival.

There are preclinical data in lung cancer demonstrating that the same thing is true. Tina Cascone published on that years ago. We could talk about why, but it appears that neoadjuvant is just better.

There are other advantages to it as well. I think a big one is that all the information shows that it’s better tolerated, so you’re more likely to give all the drug. You can see if the drug isn’t working, and you can stop the drug. Also, if the drug is causing a side effect, you can see whether it’s working or not and use that decision to stop. It’s different than when you’re giving a drug in the adjuvant setting where you don’t really know whether it is working or not.

I think that it’s time to change some of our standards. When patients appear with lung cancers other than tiny ones that might be detected through screening, you need to convene your multidisciplinary group. You need to weigh the pros and cons I think that it’s time to change some of our standards. When patients appear with lung cancers other than tiny ones that might be detected through screening, you need to convene your multidisciplinary group coming in. It’s already an FDA-approved regimen with nivolumab and chemotherapy, and I think we’re moving to making that our standard of care now.

The way to handle it today, though, is to convene your multidisciplinary panel about every patient other than those with the tiniest of lung cancers and put your heads together to see what the best treatment is for that patient.

Dr. Kris is professor of medicine, Weill Cornell Medicine, and the William and Joy Ruane Chair in Thoracic Oncology, Memorial Sloan Kettering Cancer Center, both in New York. He disclosed ties with Ariad Pharmaceuticals, AstraZeneca, Pfizer, PUMA, and Roche/Genentech.

A version of this article appeared on Medscape.com.

I’m speaking today about the ever-rising prominence of neoadjuvant therapy for patients with locally advanced lung cancers. There are more and more data emerging suggesting that the neoadjuvant strategy is a better one.

Many of you saw the press release from Merck announcing that their randomized trial comparing chemo with chemo plus pembrolizumab in the neoadjuvant setting led to improved event-free survival and also improved pathologic complete response rate.

This comes in addition to the data from the AstraZeneca trial with durvalumab saying they’ve already achieved their endpoint of higher pathologic complete response rate vs. chemotherapy alone and also the data with nivolumab from Bristol-Myers Squibb saying that nivolumab plus chemotherapy leads to a better event-free survival and a better pathologic complete response rate. That information has led to Food and Drug Administration approval for their regimen.

We’re running the table with these very positive data, and I think it’s just a sign that the approach is safe and effective.

A huge question has come up. I just came from a meeting of lung cancer experts asking what to do if you have a patient with a small tumor, for example, a 3-cm tumor. Do you recommend immediate surgery followed by adjuvant therapy, chemotherapy, and then a checkpoint inhibitor if appropriate? Or do you proceed with neoadjuvant therapy if appropriate? The truth is that it’s a very difficult decision.

We have overwhelming data that the neoadjuvant approach works for that patient. Please remember that this is a clinically staged patient. This is not the patient after their surgery, where I think we have a very clear path. We have adjuvant data and adjuvant trials for those patients.

For the patient who’s in your office with a small tumor or a small tumor and only hilar lymphadenopathy, the decision there isn’t data driven, but rather it is experience driven. The data that are out there right now suggest that neoadjuvant therapy is a better way to go. Why is that?

Well, I think that the first reason is that it is probably a better regimen. I think many of you saw the recent clinical trial by Patel and colleagues in the New England Journal of Medicine with melanoma. It was an interesting trial. They gave a checkpoint inhibitor for 18 doses after surgery for melanoma versus three doses of checkpoint inhibitor, surgery, and then 15 doses of the checkpoint inhibitor.

It was 18 doses versus 18 doses, with the only difference being the three doses before surgery. Lo and behold, the three doses before surgery led to a better event-free survival.

There are preclinical data in lung cancer demonstrating that the same thing is true. Tina Cascone published on that years ago. We could talk about why, but it appears that neoadjuvant is just better.

There are other advantages to it as well. I think a big one is that all the information shows that it’s better tolerated, so you’re more likely to give all the drug. You can see if the drug isn’t working, and you can stop the drug. Also, if the drug is causing a side effect, you can see whether it’s working or not and use that decision to stop. It’s different than when you’re giving a drug in the adjuvant setting where you don’t really know whether it is working or not.

I think that it’s time to change some of our standards. When patients appear with lung cancers other than tiny ones that might be detected through screening, you need to convene your multidisciplinary group. You need to weigh the pros and cons I think that it’s time to change some of our standards. When patients appear with lung cancers other than tiny ones that might be detected through screening, you need to convene your multidisciplinary group coming in. It’s already an FDA-approved regimen with nivolumab and chemotherapy, and I think we’re moving to making that our standard of care now.

The way to handle it today, though, is to convene your multidisciplinary panel about every patient other than those with the tiniest of lung cancers and put your heads together to see what the best treatment is for that patient.

Dr. Kris is professor of medicine, Weill Cornell Medicine, and the William and Joy Ruane Chair in Thoracic Oncology, Memorial Sloan Kettering Cancer Center, both in New York. He disclosed ties with Ariad Pharmaceuticals, AstraZeneca, Pfizer, PUMA, and Roche/Genentech.

A version of this article appeared on Medscape.com.

HONOLULU – Sexual and gender minority (SGM) people are at increased risk for asthma severity, compared with non-SGM people, and asthma is especially exacerbated in SGM persons who use e-cigarettes compared with heterosexuals.

These findings come from a study of asthma severity among SGM people, with a special focus on the contribution of tobacco, reported Tugba Kaplan, MD, a resident in internal medicine at Luminis Health Anne Arundel Medical Center, Annapolis, Md.

“To the best of our knowledge, this is the first study assessing asthma severity among SGM people in a nationally representative longitudinal cohort study,” she said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

There has been only limited research on the health status and health needs of SGM people, and most of the studies conducted have focused on issues such as HIV/AIDS, sexual health, and substance use, not respiratory health, she said.
 

Following the PATH

Dr. Kaplan and colleagues drew on data from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort study with data on approximately 46,000 adults and adolescents in the United States.

The study uses self-reported data on tobacco use patterns; perceptions of risk and attitudes toward tobacco products; tobacco initiation, cessation, and relapse; and associated health outcomes.

The investigators combined data from three waves of the PATH Study, conducted from 2015 to 2019 on nonpregnant participants aged 18 years and older, and used mixed-effect logistic regression models to look for potential associations between sexual orientation and asthma severity.

They used standard definitions of asthma severity, based on lung function impairment measured by forced expiratory volume in 1 second and forced vital capacity, nighttime awakenings, use of a short-acting beta2-agonist for symptoms, interference with normal activity, and exacerbations requiring oral systemic corticosteroids.

The study also includes a sexual orientation question, asking participants, “do you consider yourself to be ...” with the options “straight, lesbian or gay, bisexual, something else, don’t know, or refused.”

Based on these responses, Dr. Kaplan and colleagues studied a total sample of 1,815 people who identify as SGM and 12,879 who identify as non-SGM.
 

Risks increased

In an analysis adjusted for age, sex, race/ethnicity, tobacco use, body mass index, physical activity, and asthma medication use, the authors found that, compared with non-SGM people, SGM respondents were significantly more likely to have had asthma attacks requiring steroid use in the past years (odds ratio, 1.47; 95% confidence interval, 1.01-2.15), asthma interfering with daily activities in the past month (OR, 1.33; CI, 1.10-1.61), and shortness of breath in any week over the 30 days (OR, 1.82; CI, 1.32-2.51). There was no significant difference between the groups in inhaler use over the past month, however.

They also found two interactions in the logistic regression models, one between urgent care visits and respondents who reported using both regular tobacco and e-cigarettes (dual users), and between exclusive e-cigarette use and waking up at night.

Among dual users, SGM respondents had a nearly fourfold greater risk for asthma attacks requiring urgent care visits, compared with non-SGM respondents (OR, 3.89; CI, 1.99-7.63). In contrast, among those who never used tobacco, there were no significant differences between the sexual orientation groups in regard to asthma attacks requiring urgent care visits.

Among those who reported using e-cigarettes exclusively, SGM respondents were nearly eight times more likely to report night awakening, compared with non-SGM users (OR, 7.81; CI, 2.93-20.8).

Among never users, in contrast, there was no significant difference in nighttime disturbances.
 

Possible confounders

The data suggest that “in the context of chronic illnesses like asthma, it is crucial to offer patients the knowledge and tools required to proficiently handle their conditions,” Dr. Kaplan said, adding that the differences seen between SGM and non-SGM respondents may be caused by health care disparities among SGM people that result in nonadherence to regular follow-ups.

In an interview, Jean Bourbeau, MD, MSc, who was a moderator for the session but was not involved in the study, commented that “we have to be very careful before making any conclusions, because this population could be at high risk for different reasons, and especially, do they get the same attention in terms of the care that is provided to the general population, and do they get access to the same medication?”

Nonetheless, Dr. Bourbeau continued, “I think this study is very important, because it shows us how much awareness we need to determine differences in populations, and [sexual orientation] is probably one thing that nobody had considered before, and for the first time we are now considering these potential differences in our population.”

The authors did not report a study funding source. Dr. Kaplan and Dr. Bourbeau reported having no relevant financial relationships.

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

HONOLULU – Sexual and gender minority (SGM) people are at increased risk for asthma severity, compared with non-SGM people, and asthma is especially exacerbated in SGM persons who use e-cigarettes compared with heterosexuals.

These findings come from a study of asthma severity among SGM people, with a special focus on the contribution of tobacco, reported Tugba Kaplan, MD, a resident in internal medicine at Luminis Health Anne Arundel Medical Center, Annapolis, Md.

“To the best of our knowledge, this is the first study assessing asthma severity among SGM people in a nationally representative longitudinal cohort study,” she said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

There has been only limited research on the health status and health needs of SGM people, and most of the studies conducted have focused on issues such as HIV/AIDS, sexual health, and substance use, not respiratory health, she said.
 

Following the PATH

Dr. Kaplan and colleagues drew on data from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort study with data on approximately 46,000 adults and adolescents in the United States.

The study uses self-reported data on tobacco use patterns; perceptions of risk and attitudes toward tobacco products; tobacco initiation, cessation, and relapse; and associated health outcomes.

The investigators combined data from three waves of the PATH Study, conducted from 2015 to 2019 on nonpregnant participants aged 18 years and older, and used mixed-effect logistic regression models to look for potential associations between sexual orientation and asthma severity.

They used standard definitions of asthma severity, based on lung function impairment measured by forced expiratory volume in 1 second and forced vital capacity, nighttime awakenings, use of a short-acting beta2-agonist for symptoms, interference with normal activity, and exacerbations requiring oral systemic corticosteroids.

The study also includes a sexual orientation question, asking participants, “do you consider yourself to be ...” with the options “straight, lesbian or gay, bisexual, something else, don’t know, or refused.”

Based on these responses, Dr. Kaplan and colleagues studied a total sample of 1,815 people who identify as SGM and 12,879 who identify as non-SGM.
 

Risks increased

In an analysis adjusted for age, sex, race/ethnicity, tobacco use, body mass index, physical activity, and asthma medication use, the authors found that, compared with non-SGM people, SGM respondents were significantly more likely to have had asthma attacks requiring steroid use in the past years (odds ratio, 1.47; 95% confidence interval, 1.01-2.15), asthma interfering with daily activities in the past month (OR, 1.33; CI, 1.10-1.61), and shortness of breath in any week over the 30 days (OR, 1.82; CI, 1.32-2.51). There was no significant difference between the groups in inhaler use over the past month, however.

They also found two interactions in the logistic regression models, one between urgent care visits and respondents who reported using both regular tobacco and e-cigarettes (dual users), and between exclusive e-cigarette use and waking up at night.

Among dual users, SGM respondents had a nearly fourfold greater risk for asthma attacks requiring urgent care visits, compared with non-SGM respondents (OR, 3.89; CI, 1.99-7.63). In contrast, among those who never used tobacco, there were no significant differences between the sexual orientation groups in regard to asthma attacks requiring urgent care visits.

Among those who reported using e-cigarettes exclusively, SGM respondents were nearly eight times more likely to report night awakening, compared with non-SGM users (OR, 7.81; CI, 2.93-20.8).

Among never users, in contrast, there was no significant difference in nighttime disturbances.
 

Possible confounders

The data suggest that “in the context of chronic illnesses like asthma, it is crucial to offer patients the knowledge and tools required to proficiently handle their conditions,” Dr. Kaplan said, adding that the differences seen between SGM and non-SGM respondents may be caused by health care disparities among SGM people that result in nonadherence to regular follow-ups.

In an interview, Jean Bourbeau, MD, MSc, who was a moderator for the session but was not involved in the study, commented that “we have to be very careful before making any conclusions, because this population could be at high risk for different reasons, and especially, do they get the same attention in terms of the care that is provided to the general population, and do they get access to the same medication?”

Nonetheless, Dr. Bourbeau continued, “I think this study is very important, because it shows us how much awareness we need to determine differences in populations, and [sexual orientation] is probably one thing that nobody had considered before, and for the first time we are now considering these potential differences in our population.”

The authors did not report a study funding source. Dr. Kaplan and Dr. Bourbeau reported having no relevant financial relationships.

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

HONOLULU – Sexual and gender minority (SGM) people are at increased risk for asthma severity, compared with non-SGM people, and asthma is especially exacerbated in SGM persons who use e-cigarettes compared with heterosexuals.

These findings come from a study of asthma severity among SGM people, with a special focus on the contribution of tobacco, reported Tugba Kaplan, MD, a resident in internal medicine at Luminis Health Anne Arundel Medical Center, Annapolis, Md.

“To the best of our knowledge, this is the first study assessing asthma severity among SGM people in a nationally representative longitudinal cohort study,” she said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

There has been only limited research on the health status and health needs of SGM people, and most of the studies conducted have focused on issues such as HIV/AIDS, sexual health, and substance use, not respiratory health, she said.
 

Following the PATH

Dr. Kaplan and colleagues drew on data from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort study with data on approximately 46,000 adults and adolescents in the United States.

The study uses self-reported data on tobacco use patterns; perceptions of risk and attitudes toward tobacco products; tobacco initiation, cessation, and relapse; and associated health outcomes.

The investigators combined data from three waves of the PATH Study, conducted from 2015 to 2019 on nonpregnant participants aged 18 years and older, and used mixed-effect logistic regression models to look for potential associations between sexual orientation and asthma severity.

They used standard definitions of asthma severity, based on lung function impairment measured by forced expiratory volume in 1 second and forced vital capacity, nighttime awakenings, use of a short-acting beta2-agonist for symptoms, interference with normal activity, and exacerbations requiring oral systemic corticosteroids.

The study also includes a sexual orientation question, asking participants, “do you consider yourself to be ...” with the options “straight, lesbian or gay, bisexual, something else, don’t know, or refused.”

Based on these responses, Dr. Kaplan and colleagues studied a total sample of 1,815 people who identify as SGM and 12,879 who identify as non-SGM.
 

Risks increased

In an analysis adjusted for age, sex, race/ethnicity, tobacco use, body mass index, physical activity, and asthma medication use, the authors found that, compared with non-SGM people, SGM respondents were significantly more likely to have had asthma attacks requiring steroid use in the past years (odds ratio, 1.47; 95% confidence interval, 1.01-2.15), asthma interfering with daily activities in the past month (OR, 1.33; CI, 1.10-1.61), and shortness of breath in any week over the 30 days (OR, 1.82; CI, 1.32-2.51). There was no significant difference between the groups in inhaler use over the past month, however.

They also found two interactions in the logistic regression models, one between urgent care visits and respondents who reported using both regular tobacco and e-cigarettes (dual users), and between exclusive e-cigarette use and waking up at night.

Among dual users, SGM respondents had a nearly fourfold greater risk for asthma attacks requiring urgent care visits, compared with non-SGM respondents (OR, 3.89; CI, 1.99-7.63). In contrast, among those who never used tobacco, there were no significant differences between the sexual orientation groups in regard to asthma attacks requiring urgent care visits.

Among those who reported using e-cigarettes exclusively, SGM respondents were nearly eight times more likely to report night awakening, compared with non-SGM users (OR, 7.81; CI, 2.93-20.8).

Among never users, in contrast, there was no significant difference in nighttime disturbances.
 

Possible confounders

The data suggest that “in the context of chronic illnesses like asthma, it is crucial to offer patients the knowledge and tools required to proficiently handle their conditions,” Dr. Kaplan said, adding that the differences seen between SGM and non-SGM respondents may be caused by health care disparities among SGM people that result in nonadherence to regular follow-ups.

In an interview, Jean Bourbeau, MD, MSc, who was a moderator for the session but was not involved in the study, commented that “we have to be very careful before making any conclusions, because this population could be at high risk for different reasons, and especially, do they get the same attention in terms of the care that is provided to the general population, and do they get access to the same medication?”

Nonetheless, Dr. Bourbeau continued, “I think this study is very important, because it shows us how much awareness we need to determine differences in populations, and [sexual orientation] is probably one thing that nobody had considered before, and for the first time we are now considering these potential differences in our population.”

The authors did not report a study funding source. Dr. Kaplan and Dr. Bourbeau reported having no relevant financial relationships.

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

HONOLULU – Patients with acute respiratory distress syndrome (ARDS) and coexisting pulmonary hypertension (PH) are significantly more likely to have longer and more costly hospital stays and to die in-hospital than patients with ARDS without PH, results of a retrospective study suggest.

Among more than 156,000 hospitalized patients with ARDS, 16.8% of whom also had a diagnosis of PH, the presence of PH was associated with about a 50% higher risk for in-hospital mortality and a 37% higher risk for longer hospital stays. In addition, the presence of PH was associated with nearly $20,000 of higher hospital expenditures, reported Kaushik Kumar, MBBS, at the annual meeting of the American College of Chest Physicians (CHEST).

“Clinicians should be vigilant in identifying and managing pulmonary hypertension in ARDS patients,” Dr. Kumar, a resident in internal medicine at Medstar Health, Baltimore, said in an oral abstract presentation.

He added that PH has the potential to serve as an indicator of disease severity for patients with ARDS.
 

National database

PH is a frequent complication of ARDS, likely related to a combination of pulmonary vasoconstriction, thromboembolism, and interstitial edema, he said.

To test their hypothesis that the presence of PH in patients with ARDS is associated with worse outcomes, Dr. Kumar and colleagues drew on the National Inpatient Sample database for information on adults aged 18 years and older who had been diagnosed with ARDS with or without PH.

They identified a total of 156,687 patients of whom 26,324 (16.8%) also had been diagnosed with PH. Among the cohort with PH, there were higher proportions of older patients, women, and patients with multiple comorbidities.

The in-hospital mortality rate was 36.8% among patients with PH, compared with 24.6% among those without. The mean length of stay was also longer among patients with PH, at 12 days versus 10 days.

In an unadjusted analysis, mean total hospital charges for patients with ARDS and PH were $210,165, versus $160,683 for patients with ARDS who did not have PH.

In an analysis in which the investigators controlled for age, sex, index admission length of stay, insurance status, and comorbidities, in-hospital mortality for patients with PH remained significantly higher, with an odds ratio of 1.52 (P < .001). PH was also significantly associated with longer length of stay (odds ratio, 1.37; P < .001) and higher total hospital costs, with a mean difference of $19,406.

Dr. Kumar said that the findings underscore the importance of a tailored approach to managing patients with ARDS, especially in the presence of PH.

The investigators plan further studies to assess the role of PH-targeted therapies, to examine the role of sepsis and right ventricular failure and to explore the long-term impact of PH among ARDS survivors, including effects with respect to pulmonary function, quality of life, and long-term morbidity.
 

Potential to inform practice

A pulmonologist who was not involved in the study said in an interview that the findings of the trial suggest that PH may have a greater influence on mortality than is currently understood and that further investigations into this association could change practice in the future.

“I think it would be very important for us to understand if that is going to change our outlook on how ARDS is managed. It’s possible that some of the interventions that we give people who don’t have pulmonary hypertension, for example, increasing the airway pressure in order to minimize oxygenation, may have a detrimental effect on the pulmonary vasculature,” said Timothy Morris, MD, medical director of the pulmonary and exercise lab and professor of medicine at the University of California, San Diego.

“I think it’s a little bit premature to say that this should guide management now, but it’s certainly an interesting question that may end up changing practice in the future,” said Dr. Morris, who was moderator of the session in which Dr. Kumar presented the data.

The study was supported by the Agency for Healthcare Research and Quality and Medstar Health Research Institute. Dr. Kumar and Dr. Morris have disclosed no relevant financial relationships.

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

HONOLULU – Patients with acute respiratory distress syndrome (ARDS) and coexisting pulmonary hypertension (PH) are significantly more likely to have longer and more costly hospital stays and to die in-hospital than patients with ARDS without PH, results of a retrospective study suggest.

Among more than 156,000 hospitalized patients with ARDS, 16.8% of whom also had a diagnosis of PH, the presence of PH was associated with about a 50% higher risk for in-hospital mortality and a 37% higher risk for longer hospital stays. In addition, the presence of PH was associated with nearly $20,000 of higher hospital expenditures, reported Kaushik Kumar, MBBS, at the annual meeting of the American College of Chest Physicians (CHEST).

“Clinicians should be vigilant in identifying and managing pulmonary hypertension in ARDS patients,” Dr. Kumar, a resident in internal medicine at Medstar Health, Baltimore, said in an oral abstract presentation.

He added that PH has the potential to serve as an indicator of disease severity for patients with ARDS.
 

National database

PH is a frequent complication of ARDS, likely related to a combination of pulmonary vasoconstriction, thromboembolism, and interstitial edema, he said.

To test their hypothesis that the presence of PH in patients with ARDS is associated with worse outcomes, Dr. Kumar and colleagues drew on the National Inpatient Sample database for information on adults aged 18 years and older who had been diagnosed with ARDS with or without PH.

They identified a total of 156,687 patients of whom 26,324 (16.8%) also had been diagnosed with PH. Among the cohort with PH, there were higher proportions of older patients, women, and patients with multiple comorbidities.

The in-hospital mortality rate was 36.8% among patients with PH, compared with 24.6% among those without. The mean length of stay was also longer among patients with PH, at 12 days versus 10 days.

In an unadjusted analysis, mean total hospital charges for patients with ARDS and PH were $210,165, versus $160,683 for patients with ARDS who did not have PH.

In an analysis in which the investigators controlled for age, sex, index admission length of stay, insurance status, and comorbidities, in-hospital mortality for patients with PH remained significantly higher, with an odds ratio of 1.52 (P < .001). PH was also significantly associated with longer length of stay (odds ratio, 1.37; P < .001) and higher total hospital costs, with a mean difference of $19,406.

Dr. Kumar said that the findings underscore the importance of a tailored approach to managing patients with ARDS, especially in the presence of PH.

The investigators plan further studies to assess the role of PH-targeted therapies, to examine the role of sepsis and right ventricular failure and to explore the long-term impact of PH among ARDS survivors, including effects with respect to pulmonary function, quality of life, and long-term morbidity.
 

Potential to inform practice

A pulmonologist who was not involved in the study said in an interview that the findings of the trial suggest that PH may have a greater influence on mortality than is currently understood and that further investigations into this association could change practice in the future.

“I think it would be very important for us to understand if that is going to change our outlook on how ARDS is managed. It’s possible that some of the interventions that we give people who don’t have pulmonary hypertension, for example, increasing the airway pressure in order to minimize oxygenation, may have a detrimental effect on the pulmonary vasculature,” said Timothy Morris, MD, medical director of the pulmonary and exercise lab and professor of medicine at the University of California, San Diego.

“I think it’s a little bit premature to say that this should guide management now, but it’s certainly an interesting question that may end up changing practice in the future,” said Dr. Morris, who was moderator of the session in which Dr. Kumar presented the data.

The study was supported by the Agency for Healthcare Research and Quality and Medstar Health Research Institute. Dr. Kumar and Dr. Morris have disclosed no relevant financial relationships.

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

HONOLULU – Patients with acute respiratory distress syndrome (ARDS) and coexisting pulmonary hypertension (PH) are significantly more likely to have longer and more costly hospital stays and to die in-hospital than patients with ARDS without PH, results of a retrospective study suggest.

Among more than 156,000 hospitalized patients with ARDS, 16.8% of whom also had a diagnosis of PH, the presence of PH was associated with about a 50% higher risk for in-hospital mortality and a 37% higher risk for longer hospital stays. In addition, the presence of PH was associated with nearly $20,000 of higher hospital expenditures, reported Kaushik Kumar, MBBS, at the annual meeting of the American College of Chest Physicians (CHEST).

“Clinicians should be vigilant in identifying and managing pulmonary hypertension in ARDS patients,” Dr. Kumar, a resident in internal medicine at Medstar Health, Baltimore, said in an oral abstract presentation.

He added that PH has the potential to serve as an indicator of disease severity for patients with ARDS.
 

National database

PH is a frequent complication of ARDS, likely related to a combination of pulmonary vasoconstriction, thromboembolism, and interstitial edema, he said.

To test their hypothesis that the presence of PH in patients with ARDS is associated with worse outcomes, Dr. Kumar and colleagues drew on the National Inpatient Sample database for information on adults aged 18 years and older who had been diagnosed with ARDS with or without PH.

They identified a total of 156,687 patients of whom 26,324 (16.8%) also had been diagnosed with PH. Among the cohort with PH, there were higher proportions of older patients, women, and patients with multiple comorbidities.

The in-hospital mortality rate was 36.8% among patients with PH, compared with 24.6% among those without. The mean length of stay was also longer among patients with PH, at 12 days versus 10 days.

In an unadjusted analysis, mean total hospital charges for patients with ARDS and PH were $210,165, versus $160,683 for patients with ARDS who did not have PH.

In an analysis in which the investigators controlled for age, sex, index admission length of stay, insurance status, and comorbidities, in-hospital mortality for patients with PH remained significantly higher, with an odds ratio of 1.52 (P < .001). PH was also significantly associated with longer length of stay (odds ratio, 1.37; P < .001) and higher total hospital costs, with a mean difference of $19,406.

Dr. Kumar said that the findings underscore the importance of a tailored approach to managing patients with ARDS, especially in the presence of PH.

The investigators plan further studies to assess the role of PH-targeted therapies, to examine the role of sepsis and right ventricular failure and to explore the long-term impact of PH among ARDS survivors, including effects with respect to pulmonary function, quality of life, and long-term morbidity.
 

Potential to inform practice

A pulmonologist who was not involved in the study said in an interview that the findings of the trial suggest that PH may have a greater influence on mortality than is currently understood and that further investigations into this association could change practice in the future.

“I think it would be very important for us to understand if that is going to change our outlook on how ARDS is managed. It’s possible that some of the interventions that we give people who don’t have pulmonary hypertension, for example, increasing the airway pressure in order to minimize oxygenation, may have a detrimental effect on the pulmonary vasculature,” said Timothy Morris, MD, medical director of the pulmonary and exercise lab and professor of medicine at the University of California, San Diego.

“I think it’s a little bit premature to say that this should guide management now, but it’s certainly an interesting question that may end up changing practice in the future,” said Dr. Morris, who was moderator of the session in which Dr. Kumar presented the data.

The study was supported by the Agency for Healthcare Research and Quality and Medstar Health Research Institute. Dr. Kumar and Dr. Morris have disclosed no relevant financial relationships.

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

The newly approved respiratory syncytial virus vaccine administered during pregnancy substantially reduces the clinical and economic burden of lower respiratory tract disease caused by RSV, according to research presented at an annual scientific meeting on infectious diseases.

“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.

“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.

This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.

The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
 

Strong efficacy data

Most children are infected with RSV at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis.

As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
 

New modeling study

Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.

According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.

With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.

Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.

Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.

Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.

Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”

In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.

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

The newly approved respiratory syncytial virus vaccine administered during pregnancy substantially reduces the clinical and economic burden of lower respiratory tract disease caused by RSV, according to research presented at an annual scientific meeting on infectious diseases.

“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.

“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.

This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.

The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
 

Strong efficacy data

Most children are infected with RSV at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis.

As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
 

New modeling study

Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.

According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.

With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.

Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.

Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.

Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.

Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”

In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.

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

The newly approved respiratory syncytial virus vaccine administered during pregnancy substantially reduces the clinical and economic burden of lower respiratory tract disease caused by RSV, according to research presented at an annual scientific meeting on infectious diseases.

“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.

“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.

This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.

The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
 

Strong efficacy data

Most children are infected with RSV at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis.

As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
 

New modeling study

Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.

According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.

With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.

Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.

Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.

Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.

Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”

In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.

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

Thoracic Oncology & Chest Imaging Network

Pleural Disease Section

After more than a decade, the British Thoracic Society (BTS) released updated guidelines for pleural disease (Roberts ME , et al. Thorax 2023; 78, s1-s42). Their focus includes spontaneous pneumothorax, undiagnosed unilateral pleural effusion, pleural infections, and malignant pleural effusion (MPE). Separate statements for pleural procedures (Asciak R et al. Thorax. 2023;78:s43-s68) and pleural mesothelioma (Woolhouse I et al. Thorax. 2018;73:i1-i30) are available.

Major highlights of the recommendations are as follows:

• Conservative management can be considered for minimally symptomatic primary spontaneous pneumothorax regardless of size. A multi-disciplinary approach and shared decision-making is vital, especially when deciding between needle aspiration, intercostal drainage or ambulatory devices. Special recommendations were for pregnancy, cystic fibrosis, catamenial, iatrogenic and familial.
• Undiagnosed unilateral pleural effusion. Besides pleural fluid studies, in those with unclear etiology, thoracoscopic or image-guided pleural biopsy is recommended.
• Pleural infection. Use of renal, age, purulence, infection source, dietary factors (RAPID) scoring may be considered for risk stratification. Drainage of the pleural space with catheter and intrapleural therapy with combination tissue plasminogen activator (TPA) and DNAse in residual pleural fluid should be considered. Medical thoracoscopy not supported due to lack of evidence.
• MPE. Definitive pleural intervention based on symptoms and shared decision making was supported. Modality may include talc slurry via chest tube, talc poudrage via thoracoscopy or talc instillation via indwelling pleural catheter. Intrapleural chemotherapy should not be routinely used for treatment of MPE.

These guidelines provide a comprehensive consensus to the literature and reinforce prior recommendations of other professional societies (Gilbert CR et al. Chest. 2020;158:2221-8. Miller RJ et al.; J Bronchology Interv Pulmonol. 2020;27[4]:229-45. Feller-Kopman DJ et al.; Am J Respir Crit Care Med. 2018;198:839-49).

Munish Sharma, MD

Hiren Mehta, MD, Section Member-at-Large

Philip Ong, MD, Section Member-at-Large

Thoracic Oncology & Chest Imaging Network

Pleural Disease Section

After more than a decade, the British Thoracic Society (BTS) released updated guidelines for pleural disease (Roberts ME , et al. Thorax 2023; 78, s1-s42). Their focus includes spontaneous pneumothorax, undiagnosed unilateral pleural effusion, pleural infections, and malignant pleural effusion (MPE). Separate statements for pleural procedures (Asciak R et al. Thorax. 2023;78:s43-s68) and pleural mesothelioma (Woolhouse I et al. Thorax. 2018;73:i1-i30) are available.

Major highlights of the recommendations are as follows:

• Conservative management can be considered for minimally symptomatic primary spontaneous pneumothorax regardless of size. A multi-disciplinary approach and shared decision-making is vital, especially when deciding between needle aspiration, intercostal drainage or ambulatory devices. Special recommendations were for pregnancy, cystic fibrosis, catamenial, iatrogenic and familial.
• Undiagnosed unilateral pleural effusion. Besides pleural fluid studies, in those with unclear etiology, thoracoscopic or image-guided pleural biopsy is recommended.
• Pleural infection. Use of renal, age, purulence, infection source, dietary factors (RAPID) scoring may be considered for risk stratification. Drainage of the pleural space with catheter and intrapleural therapy with combination tissue plasminogen activator (TPA) and DNAse in residual pleural fluid should be considered. Medical thoracoscopy not supported due to lack of evidence.
• MPE. Definitive pleural intervention based on symptoms and shared decision making was supported. Modality may include talc slurry via chest tube, talc poudrage via thoracoscopy or talc instillation via indwelling pleural catheter. Intrapleural chemotherapy should not be routinely used for treatment of MPE.

These guidelines provide a comprehensive consensus to the literature and reinforce prior recommendations of other professional societies (Gilbert CR et al. Chest. 2020;158:2221-8. Miller RJ et al.; J Bronchology Interv Pulmonol. 2020;27[4]:229-45. Feller-Kopman DJ et al.; Am J Respir Crit Care Med. 2018;198:839-49).

Munish Sharma, MD

Hiren Mehta, MD, Section Member-at-Large

Philip Ong, MD, Section Member-at-Large

Thoracic Oncology & Chest Imaging Network

Pleural Disease Section

After more than a decade, the British Thoracic Society (BTS) released updated guidelines for pleural disease (Roberts ME , et al. Thorax 2023; 78, s1-s42). Their focus includes spontaneous pneumothorax, undiagnosed unilateral pleural effusion, pleural infections, and malignant pleural effusion (MPE). Separate statements for pleural procedures (Asciak R et al. Thorax. 2023;78:s43-s68) and pleural mesothelioma (Woolhouse I et al. Thorax. 2018;73:i1-i30) are available.

Major highlights of the recommendations are as follows:

• Conservative management can be considered for minimally symptomatic primary spontaneous pneumothorax regardless of size. A multi-disciplinary approach and shared decision-making is vital, especially when deciding between needle aspiration, intercostal drainage or ambulatory devices. Special recommendations were for pregnancy, cystic fibrosis, catamenial, iatrogenic and familial.
• Undiagnosed unilateral pleural effusion. Besides pleural fluid studies, in those with unclear etiology, thoracoscopic or image-guided pleural biopsy is recommended.
• Pleural infection. Use of renal, age, purulence, infection source, dietary factors (RAPID) scoring may be considered for risk stratification. Drainage of the pleural space with catheter and intrapleural therapy with combination tissue plasminogen activator (TPA) and DNAse in residual pleural fluid should be considered. Medical thoracoscopy not supported due to lack of evidence.
• MPE. Definitive pleural intervention based on symptoms and shared decision making was supported. Modality may include talc slurry via chest tube, talc poudrage via thoracoscopy or talc instillation via indwelling pleural catheter. Intrapleural chemotherapy should not be routinely used for treatment of MPE.

These guidelines provide a comprehensive consensus to the literature and reinforce prior recommendations of other professional societies (Gilbert CR et al. Chest. 2020;158:2221-8. Miller RJ et al.; J Bronchology Interv Pulmonol. 2020;27[4]:229-45. Feller-Kopman DJ et al.; Am J Respir Crit Care Med. 2018;198:839-49).

Munish Sharma, MD

Hiren Mehta, MD, Section Member-at-Large

Philip Ong, MD, Section Member-at-Large

Sleep Medicine Network

Respiratory-Related Sleep Disorders Section

The overlap syndrome (OS), which refers to the co-occurrence of OSA and COPD, was first described by Flenley in 1985 (Flenley DC. Clin Chest Med. 1985;6[4]:651). Over the years, numerous studies have demonstrated an increased risk of hospitalization and mortality in patients with OS (Brennan M, et al. 2022;1-10). Despite these findings, limited evidence exists regarding the optimal treatment approach for individuals with OS.

CPAP therapy has demonstrated various physiologic advantages for patients with OS (Srivali N, et al. Sleep Med. 2023;108:55-60), which contribute to diminished dyspnea symptoms, lowered pro-inflammatory markers, improved arterial blood gases, increased 6-minute walk distance, enhanced FEV₁, and decreased mean pulmonary artery pressure (Suri TM, et al. FASEB BioAdv. 2021;3[9]:683-93). CPAP therapy in patients with OS has been linked to a reduction in COPD exacerbations (Voulgaris A, et al. Clin Respir Jour. 2023; 17[3]:165), fewer COPD-related hospitalizations (Marin JM, et al. Am J Respir Crit Care Med. 2010;182[3]:325-31), decreased cardiovascular events (Kendzerska T, et al. Ann ATS. 2019;16[1]:71), and an overall decline in mortality rates (Machado ML, et al. Eur Respir J. 2010;35[1]:132-7).

It is important to acknowledge that, as of now, no randomized clinical trial has specifically addressed the treatment of OS, leaving recommendations largely reliant on observational studies. Conversely, recent guidelines have proposed the utilization of high-intensity noninvasive ventilation (NIV) for hypercapnic patients with COPD. Thus, extensive research is warranted to characterize distinct sleep-related breathing disorders within the OS population and to investigate the effects of CPAP in comparison to other NIV modalities on patients with overlap syndrome.

Solmaz Ehteshami-Afshar, MD

Kirat Gill, MD, Section Member-at-Large

Sleep Medicine Network

Respiratory-Related Sleep Disorders Section

The overlap syndrome (OS), which refers to the co-occurrence of OSA and COPD, was first described by Flenley in 1985 (Flenley DC. Clin Chest Med. 1985;6[4]:651). Over the years, numerous studies have demonstrated an increased risk of hospitalization and mortality in patients with OS (Brennan M, et al. 2022;1-10). Despite these findings, limited evidence exists regarding the optimal treatment approach for individuals with OS.

CPAP therapy has demonstrated various physiologic advantages for patients with OS (Srivali N, et al. Sleep Med. 2023;108:55-60), which contribute to diminished dyspnea symptoms, lowered pro-inflammatory markers, improved arterial blood gases, increased 6-minute walk distance, enhanced FEV₁, and decreased mean pulmonary artery pressure (Suri TM, et al. FASEB BioAdv. 2021;3[9]:683-93). CPAP therapy in patients with OS has been linked to a reduction in COPD exacerbations (Voulgaris A, et al. Clin Respir Jour. 2023; 17[3]:165), fewer COPD-related hospitalizations (Marin JM, et al. Am J Respir Crit Care Med. 2010;182[3]:325-31), decreased cardiovascular events (Kendzerska T, et al. Ann ATS. 2019;16[1]:71), and an overall decline in mortality rates (Machado ML, et al. Eur Respir J. 2010;35[1]:132-7).

It is important to acknowledge that, as of now, no randomized clinical trial has specifically addressed the treatment of OS, leaving recommendations largely reliant on observational studies. Conversely, recent guidelines have proposed the utilization of high-intensity noninvasive ventilation (NIV) for hypercapnic patients with COPD. Thus, extensive research is warranted to characterize distinct sleep-related breathing disorders within the OS population and to investigate the effects of CPAP in comparison to other NIV modalities on patients with overlap syndrome.

Solmaz Ehteshami-Afshar, MD

Kirat Gill, MD, Section Member-at-Large

Sleep Medicine Network

Respiratory-Related Sleep Disorders Section

The overlap syndrome (OS), which refers to the co-occurrence of OSA and COPD, was first described by Flenley in 1985 (Flenley DC. Clin Chest Med. 1985;6[4]:651). Over the years, numerous studies have demonstrated an increased risk of hospitalization and mortality in patients with OS (Brennan M, et al. 2022;1-10). Despite these findings, limited evidence exists regarding the optimal treatment approach for individuals with OS.

CPAP therapy has demonstrated various physiologic advantages for patients with OS (Srivali N, et al. Sleep Med. 2023;108:55-60), which contribute to diminished dyspnea symptoms, lowered pro-inflammatory markers, improved arterial blood gases, increased 6-minute walk distance, enhanced FEV₁, and decreased mean pulmonary artery pressure (Suri TM, et al. FASEB BioAdv. 2021;3[9]:683-93). CPAP therapy in patients with OS has been linked to a reduction in COPD exacerbations (Voulgaris A, et al. Clin Respir Jour. 2023; 17[3]:165), fewer COPD-related hospitalizations (Marin JM, et al. Am J Respir Crit Care Med. 2010;182[3]:325-31), decreased cardiovascular events (Kendzerska T, et al. Ann ATS. 2019;16[1]:71), and an overall decline in mortality rates (Machado ML, et al. Eur Respir J. 2010;35[1]:132-7).

It is important to acknowledge that, as of now, no randomized clinical trial has specifically addressed the treatment of OS, leaving recommendations largely reliant on observational studies. Conversely, recent guidelines have proposed the utilization of high-intensity noninvasive ventilation (NIV) for hypercapnic patients with COPD. Thus, extensive research is warranted to characterize distinct sleep-related breathing disorders within the OS population and to investigate the effects of CPAP in comparison to other NIV modalities on patients with overlap syndrome.

Solmaz Ehteshami-Afshar, MD

Kirat Gill, MD, Section Member-at-Large

Diffuse Lung & Transplant Network

Pulmonary Physiology & Rehabilitation Section

Pulmonary arterial hypertension (PH) and more recently interstitial lung disease (ILD) trials use the 6-minute walk test (6MWT) as a primary outcome due to its ability to conveniently capture a patient’s functional capacity and quality of life. However, interpreting the 6MWT in complex and diverse diseases, such as ILD, presents significant challenges.

A recent article (Harari, et al. Eur Respir Rev. 2022 Aug 23;31(165):220087. doi: 10.1183/16000617.0087-2022) advocates for further research to determine the optimal use of the 6MWT as a clinical endpoint in ILD trials. A decline in 6MWT can represent progression of ILD; ILD-related PH; or musculoskeletal, hematologic, or cardiac etiologies related to the underlying cause of ILD.

To enhance sensitivity, the authors endorse the inclusion of additional parameters in the analysis, possibly as a composite outcome. This would involve integrating the oxygen desaturation profile, dyspnea scores, and heart rate recovery with changes in the 6MWT-distance. They propose this composite measure could serve as a primary endpoint when the study intervention’s impact on clinical performance – either improvement or stabilization of ILD or ILD-related PH – is clearly defined. The prognostic significance of these additional parameters in patients with ILD, however, requires further investigation.

Inter-test reliability requires a standardized 6MWT, as previously proposed for this population (Lancaster, et al. Contemporary Clin Trials. 2021;Nov 25,2020). The standardized test protocol that includes continuous pulse oximetry and heart rate measurement, oxygen titration, and end of test guidelines, will reduce variability and boost reproducibility.

In light of recent advancements in the affordability, convenience, and portability of oxygen consumption (VO2) gas analyzers, we believe that incorporating Vo2 measurements into the 6MWT is a needed incremental improvement. This integration will help define the disease process, its impact on patient performance, and clinical prognosis. Future work should focus on understanding how to effectively estimate Vo2 in combination with a standardized 6MWT to make this test a reliable clinical outcome in trials.

Ruchicka Sangani, MD, Section Fellow-in-Training

Saqib Baig, MD, Section Member-at-Large
 

Diffuse Lung & Transplant Network

Pulmonary Physiology & Rehabilitation Section

Pulmonary arterial hypertension (PH) and more recently interstitial lung disease (ILD) trials use the 6-minute walk test (6MWT) as a primary outcome due to its ability to conveniently capture a patient’s functional capacity and quality of life. However, interpreting the 6MWT in complex and diverse diseases, such as ILD, presents significant challenges.

A recent article (Harari, et al. Eur Respir Rev. 2022 Aug 23;31(165):220087. doi: 10.1183/16000617.0087-2022) advocates for further research to determine the optimal use of the 6MWT as a clinical endpoint in ILD trials. A decline in 6MWT can represent progression of ILD; ILD-related PH; or musculoskeletal, hematologic, or cardiac etiologies related to the underlying cause of ILD.

To enhance sensitivity, the authors endorse the inclusion of additional parameters in the analysis, possibly as a composite outcome. This would involve integrating the oxygen desaturation profile, dyspnea scores, and heart rate recovery with changes in the 6MWT-distance. They propose this composite measure could serve as a primary endpoint when the study intervention’s impact on clinical performance – either improvement or stabilization of ILD or ILD-related PH – is clearly defined. The prognostic significance of these additional parameters in patients with ILD, however, requires further investigation.

Inter-test reliability requires a standardized 6MWT, as previously proposed for this population (Lancaster, et al. Contemporary Clin Trials. 2021;Nov 25,2020). The standardized test protocol that includes continuous pulse oximetry and heart rate measurement, oxygen titration, and end of test guidelines, will reduce variability and boost reproducibility.

In light of recent advancements in the affordability, convenience, and portability of oxygen consumption (VO2) gas analyzers, we believe that incorporating Vo2 measurements into the 6MWT is a needed incremental improvement. This integration will help define the disease process, its impact on patient performance, and clinical prognosis. Future work should focus on understanding how to effectively estimate Vo2 in combination with a standardized 6MWT to make this test a reliable clinical outcome in trials.

Ruchicka Sangani, MD, Section Fellow-in-Training

Saqib Baig, MD, Section Member-at-Large
 

Diffuse Lung & Transplant Network

Pulmonary Physiology & Rehabilitation Section

Pulmonary arterial hypertension (PH) and more recently interstitial lung disease (ILD) trials use the 6-minute walk test (6MWT) as a primary outcome due to its ability to conveniently capture a patient’s functional capacity and quality of life. However, interpreting the 6MWT in complex and diverse diseases, such as ILD, presents significant challenges.

A recent article (Harari, et al. Eur Respir Rev. 2022 Aug 23;31(165):220087. doi: 10.1183/16000617.0087-2022) advocates for further research to determine the optimal use of the 6MWT as a clinical endpoint in ILD trials. A decline in 6MWT can represent progression of ILD; ILD-related PH; or musculoskeletal, hematologic, or cardiac etiologies related to the underlying cause of ILD.

To enhance sensitivity, the authors endorse the inclusion of additional parameters in the analysis, possibly as a composite outcome. This would involve integrating the oxygen desaturation profile, dyspnea scores, and heart rate recovery with changes in the 6MWT-distance. They propose this composite measure could serve as a primary endpoint when the study intervention’s impact on clinical performance – either improvement or stabilization of ILD or ILD-related PH – is clearly defined. The prognostic significance of these additional parameters in patients with ILD, however, requires further investigation.

Inter-test reliability requires a standardized 6MWT, as previously proposed for this population (Lancaster, et al. Contemporary Clin Trials. 2021;Nov 25,2020). The standardized test protocol that includes continuous pulse oximetry and heart rate measurement, oxygen titration, and end of test guidelines, will reduce variability and boost reproducibility.

In light of recent advancements in the affordability, convenience, and portability of oxygen consumption (VO2) gas analyzers, we believe that incorporating Vo2 measurements into the 6MWT is a needed incremental improvement. This integration will help define the disease process, its impact on patient performance, and clinical prognosis. Future work should focus on understanding how to effectively estimate Vo2 in combination with a standardized 6MWT to make this test a reliable clinical outcome in trials.

Ruchicka Sangani, MD, Section Fellow-in-Training

Saqib Baig, MD, Section Member-at-Large
 

Critical Care Network

Sepsis/Shock Section

Beta-lactam antibiotics, including penicillin, carbapenems, and cephalosporins, exhibit time-dependent bacterial eradication. Prolonged infusions are thought to enhance the duration of effective bactericidal antibiotic exposure, decreasing the emergence of drug resistance due to reduced bacterial regrowth between doses – which may lead to cost savings by reducing drug acquisition costs and shortening hospital stays (Lodise TP Jr, et al. Clin Infect Dis. 2007;44[3]:357-63).

The best evidence for these benefits comes from observational studies and meta-analyses. The Defining Antibiotic Levels in Intensive Care Unit Patients (DALI) study emphasized the correlation between achieving target concentrations of beta-lactam antibiotics in critically ill patients and positive clinical outcomes for bloodstream infections but not for lung or intra-abdominal infections (Roberts JA, et al. Clin Infect Dis. 2014;58[8]:1072-83). A meta-analysis of 29 studies suggested that prolonged infusion of piperacillin-tazobactam was associated with a mortality benefit compared with intermittent infusions, but prolonged infusions of cephalosporins or carbapenems resulted in comparable outcomes without mortality benefit (Teo J, et al. Int J Antimicrob Agents. 2014;43[5]:403-11).

MERCY was a multinational, randomized controlled trial investigating the efficacy of continuous vs intermittent administration of meropenem in critically ill patients with sepsis. The primary outcome, a composite of mortality and emergence of resistant bacteria at day 28, showed no significant difference between continuous and intermittent administration (47% vs. 49%). Secondary outcomes and adverse events also did not display significant differences, suggesting that continuous meropenem did not improve outcomes compared with intermittent administration (Monti G, et al. JAMA. 2023;330[2]:141-51).

MERCY adds to the existing body of evidence suggesting that prolonged and intermittent infusion strategies for meropenem are at least equivalent in efficacy. Therefore, the strategy chosen can depend on other individualized factors.

The views expressed are those of the authors and do not reflect the official policy or position of the U.S. Navy, Department of Defense, or the US Government.

Critical Care Network

Sepsis/Shock Section

Beta-lactam antibiotics, including penicillin, carbapenems, and cephalosporins, exhibit time-dependent bacterial eradication. Prolonged infusions are thought to enhance the duration of effective bactericidal antibiotic exposure, decreasing the emergence of drug resistance due to reduced bacterial regrowth between doses – which may lead to cost savings by reducing drug acquisition costs and shortening hospital stays (Lodise TP Jr, et al. Clin Infect Dis. 2007;44[3]:357-63).

The best evidence for these benefits comes from observational studies and meta-analyses. The Defining Antibiotic Levels in Intensive Care Unit Patients (DALI) study emphasized the correlation between achieving target concentrations of beta-lactam antibiotics in critically ill patients and positive clinical outcomes for bloodstream infections but not for lung or intra-abdominal infections (Roberts JA, et al. Clin Infect Dis. 2014;58[8]:1072-83). A meta-analysis of 29 studies suggested that prolonged infusion of piperacillin-tazobactam was associated with a mortality benefit compared with intermittent infusions, but prolonged infusions of cephalosporins or carbapenems resulted in comparable outcomes without mortality benefit (Teo J, et al. Int J Antimicrob Agents. 2014;43[5]:403-11).

MERCY was a multinational, randomized controlled trial investigating the efficacy of continuous vs intermittent administration of meropenem in critically ill patients with sepsis. The primary outcome, a composite of mortality and emergence of resistant bacteria at day 28, showed no significant difference between continuous and intermittent administration (47% vs. 49%). Secondary outcomes and adverse events also did not display significant differences, suggesting that continuous meropenem did not improve outcomes compared with intermittent administration (Monti G, et al. JAMA. 2023;330[2]:141-51).

MERCY adds to the existing body of evidence suggesting that prolonged and intermittent infusion strategies for meropenem are at least equivalent in efficacy. Therefore, the strategy chosen can depend on other individualized factors.

The views expressed are those of the authors and do not reflect the official policy or position of the U.S. Navy, Department of Defense, or the US Government.

Critical Care Network

Sepsis/Shock Section

Beta-lactam antibiotics, including penicillin, carbapenems, and cephalosporins, exhibit time-dependent bacterial eradication. Prolonged infusions are thought to enhance the duration of effective bactericidal antibiotic exposure, decreasing the emergence of drug resistance due to reduced bacterial regrowth between doses – which may lead to cost savings by reducing drug acquisition costs and shortening hospital stays (Lodise TP Jr, et al. Clin Infect Dis. 2007;44[3]:357-63).

The best evidence for these benefits comes from observational studies and meta-analyses. The Defining Antibiotic Levels in Intensive Care Unit Patients (DALI) study emphasized the correlation between achieving target concentrations of beta-lactam antibiotics in critically ill patients and positive clinical outcomes for bloodstream infections but not for lung or intra-abdominal infections (Roberts JA, et al. Clin Infect Dis. 2014;58[8]:1072-83). A meta-analysis of 29 studies suggested that prolonged infusion of piperacillin-tazobactam was associated with a mortality benefit compared with intermittent infusions, but prolonged infusions of cephalosporins or carbapenems resulted in comparable outcomes without mortality benefit (Teo J, et al. Int J Antimicrob Agents. 2014;43[5]:403-11).

MERCY was a multinational, randomized controlled trial investigating the efficacy of continuous vs intermittent administration of meropenem in critically ill patients with sepsis. The primary outcome, a composite of mortality and emergence of resistant bacteria at day 28, showed no significant difference between continuous and intermittent administration (47% vs. 49%). Secondary outcomes and adverse events also did not display significant differences, suggesting that continuous meropenem did not improve outcomes compared with intermittent administration (Monti G, et al. JAMA. 2023;330[2]:141-51).

MERCY adds to the existing body of evidence suggesting that prolonged and intermittent infusion strategies for meropenem are at least equivalent in efficacy. Therefore, the strategy chosen can depend on other individualized factors.

The views expressed are those of the authors and do not reflect the official policy or position of the U.S. Navy, Department of Defense, or the US Government.