‘Medical Methuselahs’: Treating the growing population of centenarians

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For about the past year, Priya Goel, MD, can be seen cruising around the island of Manhattan as she makes her way between visits to some of New York City’s most treasured residents: a small but essential group of patients born before the Empire State Building scraped the sky and the old Yankee Stadium had become the House That Ruth Built.

Dr. Goel, a family physician, works for Heal, a national home health care company that primarily serves people older than 65. Her practice has 10 patients older than 100 – the oldest is a 108-year-old man – whom she visits monthly.
 

The gray wave

Dr. Goel’s charges are among America’s latest baby boom – babies born a century ago, that is.

Between 1980 and 2019, the share of American centenarians, those aged 100 and up, grew faster than the total population. In 2019, 100,322 persons in the United States were at least 100 years old – more than triple the 1980 figure of 32,194, according to the U.S. Administration on Aging. By 2060, experts predict, the U.S. centenarian population will reach nearly 600,000.

Although some of the ultra-aged live in nursing homes, many continue to live independently. They require both routine and acute medical care. So, what does it take to be a physician for a centenarian?

Dr. Goel, who is in her mid-30s and could well be the great-granddaughter of some of her patients, urged her colleagues not to stereotype patients on the basis of age.

“You have to consider their functional and cognitive abilities, their ability to understand disease processes and make decisions for themselves,” Dr. Goel said. “Age is just one factor in the grand scheme of things.”

Visiting patients in their homes provides her with insights into how well they’re doing, including the safety of their environments and the depth of their social networks.

New York City has its peculiar demands. Heal provides Dr. Goel with a driver who chauffeurs her to her patient visits. She takes notes between stops.

“The idea is to have these patients remain in an environment where they’re comfortable, in surroundings where they’ve grown up or lived for many years,” she said. “A lot of them are in elevator buildings and they are wheelchair-bound or bed-bound and they physically can’t leave.”

She said she gets a far different view of the patient than does an office-based physician.

“When you go into their home, it’s very personal. You’re seeing what their daily environment is like, what their diet is like. You can see their food on the counter. You can see the level of hygiene,” Dr. Goel said. “You get to see their social support. Are their kids involved? Are they hoarding? Stuff that they wouldn’t just necessarily disclose but on a visit you get to see going into the home. It’s an extra layer of understanding that patient.”

Dr. Goel contrasted home care from care in a nursing home, where the patients are seen daily. On the basis of her observations, she decides whether to see her patients every month or every 3 months.

She applies this strategy to everyone from age 60 to over 100.
 

 

 

Tracking a growing group

Since 1995, geriatrician Thomas Perls, MD, has directed the New England Centenarian Study at Boston University. The study, largely funded by the National Institute on Aging, has enrolled 2,599 centenarian persons and 700 of their offspring. At any given time in the study, about 10% of the centenarians are alive. The study has a high mortality rate.

The people in Dr. Perls’s study range in age, but they top out at 119, the third oldest person ever in the world. Most centenarians are women.

“When we first began the study in 1995, the prevalence of centenarians in the United States was about 1 per 10,000 in the population,” Perls told this news organization. “And now, that prevalence has doubled to 1 per 5,000.”

Even if no one has achieved the record of Methuselah, the Biblical patriarch who was purported to have lived to the age of 969, some people always have lived into their 90s and beyond. Dr. Perls attributed the increase in longevity to control at the turn of the 20th century of typhoid fever, diphtheria, and other infectious diseases with effective public health measures, including the availability of clean water and improvement in socioeconomic conditions.

“Infant mortality just plummeted. So, come around 1915, 1920, we were no longer losing a quarter of our population to these diseases. That meant a quarter more of the population could age into adulthood and middle age,” he said. “A certain component of that group was, therefore, able to continue to age to a very, very old age.”

Other advances, such as antibiotics and vaccinations in the 1960s; the availability in the 1970s of much better detection and effective treatment of high blood pressure; the recognition of the harms of smoking; and much more effective treatment of cardiovascular disease and cancer have allowed many people who would have otherwise died in their 70s and 80s to live much longer. “I think what this means is that there is a substantial proportion of the population that has the biology to get to 100,” Dr. Perls said.

Perls said the Latino population and Blacks have a better track record than Whites in reaching the 100-year milestone. “The average life expectancy might be lower in these populations because of socioeconomic factors, but if they are able to get to around their early 80s, compared to Whites, their ability to get to 100 is actually better,” he said.

Asians fare best when it comes to longevity. While around 1% of White women in the United States live to 100, 10% of Asian women in Hong Kong hit that mark.

“I think some of that is better environment and health habits in Hong Kong than in the United States,” Dr. Perls said. “I think another piece may be a genetic advantage in East Asians. We’re looking into that.”

Dr. Perls said he agreed with Dr. Goel that health care providers and the lay public should not make assumptions on the basis of age alone as to how a person is doing. “People can age so very differently from one another,” he said.

Up to about age 90, the vast majority of those differences are determined by our health behaviors, such as smoking, alcohol use, exercise, sleep, the effect of our diets on weight, and access to good health care, including regular screening for problems such as high blood pressure, diabetes, and cancer. “People who are able to do everything right generally add healthy years to their lives, while those who do not have shorter life expectancies and longer periods of chronic diseases,” Dr. Perls said.

Paying diligent attention to these behaviors over the long run can have a huge payoff.

Dr. Perls’s team has found that to live beyond age 90 and on into the early 100s, protective genes can play a strong role. These genes help slow aging and decrease one’s risk for aging-related diseases. Centenarians usually have a history of aging very slowly and greatly delaying aging-related diseases and disability toward the ends of their lives.

Centenarians are the antithesis of the misguided belief that the older you get, the sicker you get. Quite the opposite occurs. For Dr. Perls, “the older you get, the healthier you’ve been.”
 

 

 

MD bias against the elderly?

Care of elderly patients is becoming essential in the practice of primary care physicians – but not all of them enjoy the work.

To be effective, physicians who treat centenarians must get a better idea of the individual patient’s functional status and comorbidities. “You absolutely cannot make assumptions on age alone,” Dr. Perls said.

The so-called “normal” temperature, 98.6° F, can spell trouble for centenarians and other very old patients, warned Natalie Baker, DNP, CRNP, an associate professor of nursing at the University of Alabama, Birmingham, and president of the 3,000-member Gerontological Advanced Practice Nurses Association.

“We have to be very cognizant of what we call a typical presentation of disease or illness and that a very subtle change in an older adult can signal a serious infection or illness,” Dr. Baker said. “If your patient has a high fever, that is a potential problem.”

The average temperature of an older adult is lower than the accepted 98.6° F, and their body’s response to an infection is slow to exhibit an increase in temperature, Dr. Baker said. “When treating centenarians, clinicians must be cognizant of other subtle signs of infection, such as decreased appetite or change in mentation,” she cautioned.

A decline in appetite or insomnia may be a subtle sign that these patients need to be evaluated, she added.
 

COVID-19 and centenarians

Three-quarters of the 1 million U.S. deaths from COVID-19 occurred in people aged 65 and older. However, Dr. Perls said centenarians may be a special subpopulation when it comes to COVID.

The Japanese Health Ministry, which follows the large centenarian population in that country, noted a marked jump in the number of centenarians during the pandemic – although the reasons for the increase aren’t clear.

Centenarians may be a bit different. Dr. Perls said some evidence suggests that the over-100 crowd may have better immune systems than younger people. “Part of the trick of getting to 100 is having a pretty good immune system,” he said.
 

Don’t mess with success

“There is no need at that point for us to try to alter their diet to what we think it might be,” Dr. Baker said. “There’s no need to start with diabetic education. They may tell you their secret is a shot of vodka every day. Why should we stop it at that age? Accept their lifestyles, because they’ve done something right to get to that age.”

Opinions differ on how to approach screening for centenarians.

Dr. Goel said guidelines for routine screening, such as colonoscopies, mammograms, and PAP smears, drop off for patients starting at 75. Dr. Perls said this strategy stems from the belief that people will die from other things first, so screening is no longer needed. Dr. Perls said he disagrees with this approach.

“Again, we can’t base our screening and health care decisions on age alone. If I have an independently functioning and robust 95-year-old man in my office, you can be sure I am going to continue recommending regular screening for colon cancer and other screenings that are normal for people who are 30 years younger,” he said.

Justin Zaghi, MD, chief medical officer at Heal, said screening patients in their late 90s and 100s for cancer generally doesn’t make sense except in some rare circumstances in which the cancer would be unlikely to be a cause of death. “However, if we are talking about screening for fall risks, hearing difficulties, poor vision, pain, and malnutrition, those screenings still absolutely make sense for patients in their late 90s and 100s,” Dr. Zaghi said.

One high-functioning 104-year-old patient of Dr. Perls underwent a total hip replacement for a hip fracture and is faring well. “Obviously, if she had end-stage dementia, we’d do everything to keep the person comfortable, or if they had medical problems that made surgery too high risk, then you don’t do it,” he said. “But if they’re otherwise, I would proceed.”
 

 

 

Avoid the ED

Dr. Goel said doctors should avoid sending patients to the emergency department, an often chaotic place that is especially unfriendly to centenarians and the very old. “Sometimes I’ve seen older patients who are being rushed to the ER, and I ask, What are the goals of care?” she said.

Clinicians caring for seniors should keep in mind that infections can cause seniors to appear confused – and this may lead the clinician to think the patient has dementia. Or, Dr. Goel said, a patient with dementia may suddenly experience much worse dementia.

“In either case, you want to make sure you’re not dealing with any underlying infection, like urinary tract infection, or pneumonia brewing, or skin infections,” she said. “Their skin is so much frailer. You want to make sure there are no bedsores.”

She has had patients whose children report that their usually placid centenarian parents are suddenly acting out. “We’ll do a urinary test and it definitely shows a urinary tract infection. You want to make sure you’re not missing out on something else before you attribute it to dementia,” she said.

Environmental changes, such as moving a patient to a new room in a hospital setting, can trigger an acute mental status change, such as delirium, she added. Helping older patients feel in control as much as possible is important.

“You want to make sure you’re orienting them to the time of day. Make sure they get up at the same time, go to bed at the same time, have clocks and calendars present – just making sure that they feel like they’re still in control of their body and their day,” she said.

Physicians should be aware of potential depression in these patients, whose experience of loss – an unavoidable consequence of outliving family and friends – can result in problems with sleep and diet, as well as a sense of social isolation.

Neal Flomenbaum, MD, professor and emergency physician-in-chief emeritus, New York–Presbyterian/Weill Cornell Medical Center in New York, said sometimes the best thing for these very elderly patients is to “get them in and out of ED as quickly as possible, and do what you can diagnostically.”

He noted that EDs have been making accommodations to serve the elderly, such as using LEDs that replicate outdoor lighting conditions, as well as providing seniors with separate rooms with glass doors to protect them from noise, separate air handlers to prevent infections, and adequate space for visitors.

These patients often are subject to trauma from falls.

“The bones don’t heal as well as in younger people, and treating their comorbidities is essential. Once they have trouble with one area and they’re lying in bed and can’t move much, they can get bedsores,” Dr. Flomenbaum said. “In the hospital, they are vulnerable to infections. So, you’re thinking of all of these things at the same time and how to treat them appropriately and then get them out of the hospital as soon as possible with whatever care that they need in their own homes if at all possible.”

“I always err on the side of less is more,” Dr. Goel said. “Obviously, if there is something – if they have a cough, they need an x-ray. That’s very basic. We want to take care of that. Give them the antibiotic if they need that. But rushing them in and out of the hospital doesn’t add to their quality of life.”

Dr. Flomenbaum, a pioneer in geriatric emergency medicine, says physicians need to be aware that centenarians and other very old patients don’t present the same way as younger adults.

He began to notice more than 20 years ago that every night, patients would turn up in his ED who were in their late 90s into their 100s. Some would come in with what their children identified as sudden-onset dementia – they didn’t know their own names and couldn’t identify their kids. They didn’t know the time or day. Dr. Flomenbaum said the children often asked whether their parents should enter a nursing home.

“And I’d say, ‘Not so fast. Well, let’s take a look at this.’ You don’t develop that kind of dementia overnight. It usually takes a while,” he said.

He said he ordered complete blood cell counts and oxygen saturation tests that frequently turned out to be abnormal. They didn’t have a fever, and infiltrates initially weren’t seen on chest x-rays.

With rehydration and supplemental oxygen, their symptoms started to improve, and it became obvious that the symptoms were not of dementia but of pneumonia, and that they required antibiotics, Dr. Flomenbaum said.
 

 

 

Dementia dilemma

Too often, on the basis of age, doctors assume patients have dementia or other cognitive impairments.

“What a shock and a surprise when doctors actually talk to folks and do a neurocognitive screen and find they’re just fine,” Dr. Perls said.

The decline in hearing and vision can lead to a misdiagnosis of cognitive impairment because the patients are not able to hear what you’re asking them. “It’s really important that the person can hear you – whether you use an amplifying device or they have hearing aids, that’s critical,” he said. “You just have to be a good doctor.”

Often the physical toll of aging exacerbates social difficulties. Poor hearing, for example, can accelerate cognitive impairment and cause people to interact less often, and less meaningfully, with their environment. For some, wearing hearing aids seems demeaning – until they hear what they’ve been missing.

“I get them to wear their hearing aids and, lo and behold, they’re a whole new person because they’re now able to take in their environment and interact with others,” Dr. Perls said.

Dr. Flomenbaum said alcohol abuse and drug reactions can cause delirium, which, unlike dementia, is potentially reversible. Yet many physicians cannot reliably differentiate between dementia and delirium, he added.

The geriatric specialists talk about the lessons they’ve learned and the gratification they get from caring for centenarians.

“I have come to realize the importance of family, of having a close circle, whether that’s through friends or neighbors,” Dr. Goel said. “This work is very rewarding because, if it wasn’t for homebound organizations, how would these people get care or get access to care?”

For Dr. Baker, a joy of the job is hearing centenarians share their life stories.

“I love to hear their stories about how they’ve overcome adversity, living through the depression and living through different wars,” she said. “I love talking to veterans, and I think that oftentimes, we do not value our older adults in our society as we should. Sometimes they are dismissed because they move slowly or are hard to communicate with due to hearing deficits. But they are, I think, a very important part of our lives.”
 

‘They’ve already won’

Most centenarians readily offer the secrets to their longevity. Aline Jacobsohn, of Boca Raton, Fla., is no different.

Ms. Jacobsohn, who will be 101 in October, thinks a diet of small portions of fish, vegetables, and fruit, which she has followed since her husband Leo died in 1982, has helped keep her healthy. She eats lots of salmon and herring and is a fan of spinach sautéed with olive oil. “The only thing I don’t eat is meat,” the trim and active Ms. Jacobsohn said in a recent interview over Zoom.

Her other secret: “Doctors. I like to stay away from them as much as possible.”

Shari Rosenbaum, MD, Jacobsohn’s internist, doesn’t dismiss that approach. She uses a version of it when managing her three centenarian patients, the oldest of whom is 103.

“Let them smoke! Let them drink! They’re happy. It’s not causing harm. Let them eat cake! They’ve already won,” said Dr. Rosenbaum, who is affiliated with Boca Raton–based MDVIP, a national membership-based network of 1,100 primary care physicians serving 368,000 patients. Of those, nearly 460 are centenarians.

“You’re not preventing those problems in this population,” she said. “They’re here to enjoy every moment that they have, and they might as well.”

Dr. Rosenbaum sees a divergence in her patients – those who will reach very old age, and those who won’t – starting in their 60s.

“The centenarians don’t have medical problems,” she said. “They don’t get cancer. They don’t get diabetes. Some of them take good care of themselves. Some don’t take such good care of themselves. But they are all optimists. They all see the glass half full. They all participate in life. They all have excellent support systems. They have good genes, a positive attitude toward life, and a strong social network.”

Ms. Jacobsohn – whose surname at the time was Bakst – grew up in Frankfurt am Main, Germany, during the rise of the Nazi regime. The family fled to Columbia in 1938, where she met and eventually married her husband, Leo, who ran a business importing clocks and watches in Cali.

In 1989, the Jacobsohns and their three children moved to south Florida to escape the dangers of kidnappings and ransoms posed by the drug cartels.

Ms. Jacobsohn agreed that she appears to have longevity genes – “good stock,” she calls it. “My mother died 23 days before she was 100. My grandmother lived till 99, almost 100,” she said.

Two years ago, she donated her car to a charity and stopped driving in the interest of her own safety and that of other drivers and pedestrians.

Ms. Jacobsohn has a strong support system. Two of her children live nearby and visit her nearly every day. A live-in companion helps her with the activities of daily life, including preparing meals.

Ms. Jacobsohn plays bridge regularly, and well. “I’m sorry to say that I’m a very good bridge player,” she said, frankly. “How is it possible that I’ve played bridge so well and then I don’t remember what I had for lunch yesterday?”

She reads, mainly a diet of history but occasionally novels, too. “They have to be engaging,” she said.

The loss of loved ones is an inevitable part of very old age. Her husband of 47 years died of emphysema, and one of her sons died in his 70s of prostate cancer.

She knows well the fate that awaits us all and accepts it philosophically.

“It’s a very normal thing that people die. You don’t live forever. So, whenever it comes, it’s okay. Enough is enough. Dayenu,” she said, using the Hebrew word for, “It would have been enough” – a favorite in the Passover Seder celebrating the ancient Jews’ liberation from slavery in Egypt.

Ms. Jacobsohn sang the song and then took a reporter on a Zoom tour of her tidy home and her large flower garden featuring Cattleya orchids from Colombia.

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

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For about the past year, Priya Goel, MD, can be seen cruising around the island of Manhattan as she makes her way between visits to some of New York City’s most treasured residents: a small but essential group of patients born before the Empire State Building scraped the sky and the old Yankee Stadium had become the House That Ruth Built.

Dr. Goel, a family physician, works for Heal, a national home health care company that primarily serves people older than 65. Her practice has 10 patients older than 100 – the oldest is a 108-year-old man – whom she visits monthly.
 

The gray wave

Dr. Goel’s charges are among America’s latest baby boom – babies born a century ago, that is.

Between 1980 and 2019, the share of American centenarians, those aged 100 and up, grew faster than the total population. In 2019, 100,322 persons in the United States were at least 100 years old – more than triple the 1980 figure of 32,194, according to the U.S. Administration on Aging. By 2060, experts predict, the U.S. centenarian population will reach nearly 600,000.

Although some of the ultra-aged live in nursing homes, many continue to live independently. They require both routine and acute medical care. So, what does it take to be a physician for a centenarian?

Dr. Goel, who is in her mid-30s and could well be the great-granddaughter of some of her patients, urged her colleagues not to stereotype patients on the basis of age.

“You have to consider their functional and cognitive abilities, their ability to understand disease processes and make decisions for themselves,” Dr. Goel said. “Age is just one factor in the grand scheme of things.”

Visiting patients in their homes provides her with insights into how well they’re doing, including the safety of their environments and the depth of their social networks.

New York City has its peculiar demands. Heal provides Dr. Goel with a driver who chauffeurs her to her patient visits. She takes notes between stops.

“The idea is to have these patients remain in an environment where they’re comfortable, in surroundings where they’ve grown up or lived for many years,” she said. “A lot of them are in elevator buildings and they are wheelchair-bound or bed-bound and they physically can’t leave.”

She said she gets a far different view of the patient than does an office-based physician.

“When you go into their home, it’s very personal. You’re seeing what their daily environment is like, what their diet is like. You can see their food on the counter. You can see the level of hygiene,” Dr. Goel said. “You get to see their social support. Are their kids involved? Are they hoarding? Stuff that they wouldn’t just necessarily disclose but on a visit you get to see going into the home. It’s an extra layer of understanding that patient.”

Dr. Goel contrasted home care from care in a nursing home, where the patients are seen daily. On the basis of her observations, she decides whether to see her patients every month or every 3 months.

She applies this strategy to everyone from age 60 to over 100.
 

 

 

Tracking a growing group

Since 1995, geriatrician Thomas Perls, MD, has directed the New England Centenarian Study at Boston University. The study, largely funded by the National Institute on Aging, has enrolled 2,599 centenarian persons and 700 of their offspring. At any given time in the study, about 10% of the centenarians are alive. The study has a high mortality rate.

The people in Dr. Perls’s study range in age, but they top out at 119, the third oldest person ever in the world. Most centenarians are women.

“When we first began the study in 1995, the prevalence of centenarians in the United States was about 1 per 10,000 in the population,” Perls told this news organization. “And now, that prevalence has doubled to 1 per 5,000.”

Even if no one has achieved the record of Methuselah, the Biblical patriarch who was purported to have lived to the age of 969, some people always have lived into their 90s and beyond. Dr. Perls attributed the increase in longevity to control at the turn of the 20th century of typhoid fever, diphtheria, and other infectious diseases with effective public health measures, including the availability of clean water and improvement in socioeconomic conditions.

“Infant mortality just plummeted. So, come around 1915, 1920, we were no longer losing a quarter of our population to these diseases. That meant a quarter more of the population could age into adulthood and middle age,” he said. “A certain component of that group was, therefore, able to continue to age to a very, very old age.”

Other advances, such as antibiotics and vaccinations in the 1960s; the availability in the 1970s of much better detection and effective treatment of high blood pressure; the recognition of the harms of smoking; and much more effective treatment of cardiovascular disease and cancer have allowed many people who would have otherwise died in their 70s and 80s to live much longer. “I think what this means is that there is a substantial proportion of the population that has the biology to get to 100,” Dr. Perls said.

Perls said the Latino population and Blacks have a better track record than Whites in reaching the 100-year milestone. “The average life expectancy might be lower in these populations because of socioeconomic factors, but if they are able to get to around their early 80s, compared to Whites, their ability to get to 100 is actually better,” he said.

Asians fare best when it comes to longevity. While around 1% of White women in the United States live to 100, 10% of Asian women in Hong Kong hit that mark.

“I think some of that is better environment and health habits in Hong Kong than in the United States,” Dr. Perls said. “I think another piece may be a genetic advantage in East Asians. We’re looking into that.”

Dr. Perls said he agreed with Dr. Goel that health care providers and the lay public should not make assumptions on the basis of age alone as to how a person is doing. “People can age so very differently from one another,” he said.

Up to about age 90, the vast majority of those differences are determined by our health behaviors, such as smoking, alcohol use, exercise, sleep, the effect of our diets on weight, and access to good health care, including regular screening for problems such as high blood pressure, diabetes, and cancer. “People who are able to do everything right generally add healthy years to their lives, while those who do not have shorter life expectancies and longer periods of chronic diseases,” Dr. Perls said.

Paying diligent attention to these behaviors over the long run can have a huge payoff.

Dr. Perls’s team has found that to live beyond age 90 and on into the early 100s, protective genes can play a strong role. These genes help slow aging and decrease one’s risk for aging-related diseases. Centenarians usually have a history of aging very slowly and greatly delaying aging-related diseases and disability toward the ends of their lives.

Centenarians are the antithesis of the misguided belief that the older you get, the sicker you get. Quite the opposite occurs. For Dr. Perls, “the older you get, the healthier you’ve been.”
 

 

 

MD bias against the elderly?

Care of elderly patients is becoming essential in the practice of primary care physicians – but not all of them enjoy the work.

To be effective, physicians who treat centenarians must get a better idea of the individual patient’s functional status and comorbidities. “You absolutely cannot make assumptions on age alone,” Dr. Perls said.

The so-called “normal” temperature, 98.6° F, can spell trouble for centenarians and other very old patients, warned Natalie Baker, DNP, CRNP, an associate professor of nursing at the University of Alabama, Birmingham, and president of the 3,000-member Gerontological Advanced Practice Nurses Association.

“We have to be very cognizant of what we call a typical presentation of disease or illness and that a very subtle change in an older adult can signal a serious infection or illness,” Dr. Baker said. “If your patient has a high fever, that is a potential problem.”

The average temperature of an older adult is lower than the accepted 98.6° F, and their body’s response to an infection is slow to exhibit an increase in temperature, Dr. Baker said. “When treating centenarians, clinicians must be cognizant of other subtle signs of infection, such as decreased appetite or change in mentation,” she cautioned.

A decline in appetite or insomnia may be a subtle sign that these patients need to be evaluated, she added.
 

COVID-19 and centenarians

Three-quarters of the 1 million U.S. deaths from COVID-19 occurred in people aged 65 and older. However, Dr. Perls said centenarians may be a special subpopulation when it comes to COVID.

The Japanese Health Ministry, which follows the large centenarian population in that country, noted a marked jump in the number of centenarians during the pandemic – although the reasons for the increase aren’t clear.

Centenarians may be a bit different. Dr. Perls said some evidence suggests that the over-100 crowd may have better immune systems than younger people. “Part of the trick of getting to 100 is having a pretty good immune system,” he said.
 

Don’t mess with success

“There is no need at that point for us to try to alter their diet to what we think it might be,” Dr. Baker said. “There’s no need to start with diabetic education. They may tell you their secret is a shot of vodka every day. Why should we stop it at that age? Accept their lifestyles, because they’ve done something right to get to that age.”

Opinions differ on how to approach screening for centenarians.

Dr. Goel said guidelines for routine screening, such as colonoscopies, mammograms, and PAP smears, drop off for patients starting at 75. Dr. Perls said this strategy stems from the belief that people will die from other things first, so screening is no longer needed. Dr. Perls said he disagrees with this approach.

“Again, we can’t base our screening and health care decisions on age alone. If I have an independently functioning and robust 95-year-old man in my office, you can be sure I am going to continue recommending regular screening for colon cancer and other screenings that are normal for people who are 30 years younger,” he said.

Justin Zaghi, MD, chief medical officer at Heal, said screening patients in their late 90s and 100s for cancer generally doesn’t make sense except in some rare circumstances in which the cancer would be unlikely to be a cause of death. “However, if we are talking about screening for fall risks, hearing difficulties, poor vision, pain, and malnutrition, those screenings still absolutely make sense for patients in their late 90s and 100s,” Dr. Zaghi said.

One high-functioning 104-year-old patient of Dr. Perls underwent a total hip replacement for a hip fracture and is faring well. “Obviously, if she had end-stage dementia, we’d do everything to keep the person comfortable, or if they had medical problems that made surgery too high risk, then you don’t do it,” he said. “But if they’re otherwise, I would proceed.”
 

 

 

Avoid the ED

Dr. Goel said doctors should avoid sending patients to the emergency department, an often chaotic place that is especially unfriendly to centenarians and the very old. “Sometimes I’ve seen older patients who are being rushed to the ER, and I ask, What are the goals of care?” she said.

Clinicians caring for seniors should keep in mind that infections can cause seniors to appear confused – and this may lead the clinician to think the patient has dementia. Or, Dr. Goel said, a patient with dementia may suddenly experience much worse dementia.

“In either case, you want to make sure you’re not dealing with any underlying infection, like urinary tract infection, or pneumonia brewing, or skin infections,” she said. “Their skin is so much frailer. You want to make sure there are no bedsores.”

She has had patients whose children report that their usually placid centenarian parents are suddenly acting out. “We’ll do a urinary test and it definitely shows a urinary tract infection. You want to make sure you’re not missing out on something else before you attribute it to dementia,” she said.

Environmental changes, such as moving a patient to a new room in a hospital setting, can trigger an acute mental status change, such as delirium, she added. Helping older patients feel in control as much as possible is important.

“You want to make sure you’re orienting them to the time of day. Make sure they get up at the same time, go to bed at the same time, have clocks and calendars present – just making sure that they feel like they’re still in control of their body and their day,” she said.

Physicians should be aware of potential depression in these patients, whose experience of loss – an unavoidable consequence of outliving family and friends – can result in problems with sleep and diet, as well as a sense of social isolation.

Neal Flomenbaum, MD, professor and emergency physician-in-chief emeritus, New York–Presbyterian/Weill Cornell Medical Center in New York, said sometimes the best thing for these very elderly patients is to “get them in and out of ED as quickly as possible, and do what you can diagnostically.”

He noted that EDs have been making accommodations to serve the elderly, such as using LEDs that replicate outdoor lighting conditions, as well as providing seniors with separate rooms with glass doors to protect them from noise, separate air handlers to prevent infections, and adequate space for visitors.

These patients often are subject to trauma from falls.

“The bones don’t heal as well as in younger people, and treating their comorbidities is essential. Once they have trouble with one area and they’re lying in bed and can’t move much, they can get bedsores,” Dr. Flomenbaum said. “In the hospital, they are vulnerable to infections. So, you’re thinking of all of these things at the same time and how to treat them appropriately and then get them out of the hospital as soon as possible with whatever care that they need in their own homes if at all possible.”

“I always err on the side of less is more,” Dr. Goel said. “Obviously, if there is something – if they have a cough, they need an x-ray. That’s very basic. We want to take care of that. Give them the antibiotic if they need that. But rushing them in and out of the hospital doesn’t add to their quality of life.”

Dr. Flomenbaum, a pioneer in geriatric emergency medicine, says physicians need to be aware that centenarians and other very old patients don’t present the same way as younger adults.

He began to notice more than 20 years ago that every night, patients would turn up in his ED who were in their late 90s into their 100s. Some would come in with what their children identified as sudden-onset dementia – they didn’t know their own names and couldn’t identify their kids. They didn’t know the time or day. Dr. Flomenbaum said the children often asked whether their parents should enter a nursing home.

“And I’d say, ‘Not so fast. Well, let’s take a look at this.’ You don’t develop that kind of dementia overnight. It usually takes a while,” he said.

He said he ordered complete blood cell counts and oxygen saturation tests that frequently turned out to be abnormal. They didn’t have a fever, and infiltrates initially weren’t seen on chest x-rays.

With rehydration and supplemental oxygen, their symptoms started to improve, and it became obvious that the symptoms were not of dementia but of pneumonia, and that they required antibiotics, Dr. Flomenbaum said.
 

 

 

Dementia dilemma

Too often, on the basis of age, doctors assume patients have dementia or other cognitive impairments.

“What a shock and a surprise when doctors actually talk to folks and do a neurocognitive screen and find they’re just fine,” Dr. Perls said.

The decline in hearing and vision can lead to a misdiagnosis of cognitive impairment because the patients are not able to hear what you’re asking them. “It’s really important that the person can hear you – whether you use an amplifying device or they have hearing aids, that’s critical,” he said. “You just have to be a good doctor.”

Often the physical toll of aging exacerbates social difficulties. Poor hearing, for example, can accelerate cognitive impairment and cause people to interact less often, and less meaningfully, with their environment. For some, wearing hearing aids seems demeaning – until they hear what they’ve been missing.

“I get them to wear their hearing aids and, lo and behold, they’re a whole new person because they’re now able to take in their environment and interact with others,” Dr. Perls said.

Dr. Flomenbaum said alcohol abuse and drug reactions can cause delirium, which, unlike dementia, is potentially reversible. Yet many physicians cannot reliably differentiate between dementia and delirium, he added.

The geriatric specialists talk about the lessons they’ve learned and the gratification they get from caring for centenarians.

“I have come to realize the importance of family, of having a close circle, whether that’s through friends or neighbors,” Dr. Goel said. “This work is very rewarding because, if it wasn’t for homebound organizations, how would these people get care or get access to care?”

For Dr. Baker, a joy of the job is hearing centenarians share their life stories.

“I love to hear their stories about how they’ve overcome adversity, living through the depression and living through different wars,” she said. “I love talking to veterans, and I think that oftentimes, we do not value our older adults in our society as we should. Sometimes they are dismissed because they move slowly or are hard to communicate with due to hearing deficits. But they are, I think, a very important part of our lives.”
 

‘They’ve already won’

Most centenarians readily offer the secrets to their longevity. Aline Jacobsohn, of Boca Raton, Fla., is no different.

Ms. Jacobsohn, who will be 101 in October, thinks a diet of small portions of fish, vegetables, and fruit, which she has followed since her husband Leo died in 1982, has helped keep her healthy. She eats lots of salmon and herring and is a fan of spinach sautéed with olive oil. “The only thing I don’t eat is meat,” the trim and active Ms. Jacobsohn said in a recent interview over Zoom.

Her other secret: “Doctors. I like to stay away from them as much as possible.”

Shari Rosenbaum, MD, Jacobsohn’s internist, doesn’t dismiss that approach. She uses a version of it when managing her three centenarian patients, the oldest of whom is 103.

“Let them smoke! Let them drink! They’re happy. It’s not causing harm. Let them eat cake! They’ve already won,” said Dr. Rosenbaum, who is affiliated with Boca Raton–based MDVIP, a national membership-based network of 1,100 primary care physicians serving 368,000 patients. Of those, nearly 460 are centenarians.

“You’re not preventing those problems in this population,” she said. “They’re here to enjoy every moment that they have, and they might as well.”

Dr. Rosenbaum sees a divergence in her patients – those who will reach very old age, and those who won’t – starting in their 60s.

“The centenarians don’t have medical problems,” she said. “They don’t get cancer. They don’t get diabetes. Some of them take good care of themselves. Some don’t take such good care of themselves. But they are all optimists. They all see the glass half full. They all participate in life. They all have excellent support systems. They have good genes, a positive attitude toward life, and a strong social network.”

Ms. Jacobsohn – whose surname at the time was Bakst – grew up in Frankfurt am Main, Germany, during the rise of the Nazi regime. The family fled to Columbia in 1938, where she met and eventually married her husband, Leo, who ran a business importing clocks and watches in Cali.

In 1989, the Jacobsohns and their three children moved to south Florida to escape the dangers of kidnappings and ransoms posed by the drug cartels.

Ms. Jacobsohn agreed that she appears to have longevity genes – “good stock,” she calls it. “My mother died 23 days before she was 100. My grandmother lived till 99, almost 100,” she said.

Two years ago, she donated her car to a charity and stopped driving in the interest of her own safety and that of other drivers and pedestrians.

Ms. Jacobsohn has a strong support system. Two of her children live nearby and visit her nearly every day. A live-in companion helps her with the activities of daily life, including preparing meals.

Ms. Jacobsohn plays bridge regularly, and well. “I’m sorry to say that I’m a very good bridge player,” she said, frankly. “How is it possible that I’ve played bridge so well and then I don’t remember what I had for lunch yesterday?”

She reads, mainly a diet of history but occasionally novels, too. “They have to be engaging,” she said.

The loss of loved ones is an inevitable part of very old age. Her husband of 47 years died of emphysema, and one of her sons died in his 70s of prostate cancer.

She knows well the fate that awaits us all and accepts it philosophically.

“It’s a very normal thing that people die. You don’t live forever. So, whenever it comes, it’s okay. Enough is enough. Dayenu,” she said, using the Hebrew word for, “It would have been enough” – a favorite in the Passover Seder celebrating the ancient Jews’ liberation from slavery in Egypt.

Ms. Jacobsohn sang the song and then took a reporter on a Zoom tour of her tidy home and her large flower garden featuring Cattleya orchids from Colombia.

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

For about the past year, Priya Goel, MD, can be seen cruising around the island of Manhattan as she makes her way between visits to some of New York City’s most treasured residents: a small but essential group of patients born before the Empire State Building scraped the sky and the old Yankee Stadium had become the House That Ruth Built.

Dr. Goel, a family physician, works for Heal, a national home health care company that primarily serves people older than 65. Her practice has 10 patients older than 100 – the oldest is a 108-year-old man – whom she visits monthly.
 

The gray wave

Dr. Goel’s charges are among America’s latest baby boom – babies born a century ago, that is.

Between 1980 and 2019, the share of American centenarians, those aged 100 and up, grew faster than the total population. In 2019, 100,322 persons in the United States were at least 100 years old – more than triple the 1980 figure of 32,194, according to the U.S. Administration on Aging. By 2060, experts predict, the U.S. centenarian population will reach nearly 600,000.

Although some of the ultra-aged live in nursing homes, many continue to live independently. They require both routine and acute medical care. So, what does it take to be a physician for a centenarian?

Dr. Goel, who is in her mid-30s and could well be the great-granddaughter of some of her patients, urged her colleagues not to stereotype patients on the basis of age.

“You have to consider their functional and cognitive abilities, their ability to understand disease processes and make decisions for themselves,” Dr. Goel said. “Age is just one factor in the grand scheme of things.”

Visiting patients in their homes provides her with insights into how well they’re doing, including the safety of their environments and the depth of their social networks.

New York City has its peculiar demands. Heal provides Dr. Goel with a driver who chauffeurs her to her patient visits. She takes notes between stops.

“The idea is to have these patients remain in an environment where they’re comfortable, in surroundings where they’ve grown up or lived for many years,” she said. “A lot of them are in elevator buildings and they are wheelchair-bound or bed-bound and they physically can’t leave.”

She said she gets a far different view of the patient than does an office-based physician.

“When you go into their home, it’s very personal. You’re seeing what their daily environment is like, what their diet is like. You can see their food on the counter. You can see the level of hygiene,” Dr. Goel said. “You get to see their social support. Are their kids involved? Are they hoarding? Stuff that they wouldn’t just necessarily disclose but on a visit you get to see going into the home. It’s an extra layer of understanding that patient.”

Dr. Goel contrasted home care from care in a nursing home, where the patients are seen daily. On the basis of her observations, she decides whether to see her patients every month or every 3 months.

She applies this strategy to everyone from age 60 to over 100.
 

 

 

Tracking a growing group

Since 1995, geriatrician Thomas Perls, MD, has directed the New England Centenarian Study at Boston University. The study, largely funded by the National Institute on Aging, has enrolled 2,599 centenarian persons and 700 of their offspring. At any given time in the study, about 10% of the centenarians are alive. The study has a high mortality rate.

The people in Dr. Perls’s study range in age, but they top out at 119, the third oldest person ever in the world. Most centenarians are women.

“When we first began the study in 1995, the prevalence of centenarians in the United States was about 1 per 10,000 in the population,” Perls told this news organization. “And now, that prevalence has doubled to 1 per 5,000.”

Even if no one has achieved the record of Methuselah, the Biblical patriarch who was purported to have lived to the age of 969, some people always have lived into their 90s and beyond. Dr. Perls attributed the increase in longevity to control at the turn of the 20th century of typhoid fever, diphtheria, and other infectious diseases with effective public health measures, including the availability of clean water and improvement in socioeconomic conditions.

“Infant mortality just plummeted. So, come around 1915, 1920, we were no longer losing a quarter of our population to these diseases. That meant a quarter more of the population could age into adulthood and middle age,” he said. “A certain component of that group was, therefore, able to continue to age to a very, very old age.”

Other advances, such as antibiotics and vaccinations in the 1960s; the availability in the 1970s of much better detection and effective treatment of high blood pressure; the recognition of the harms of smoking; and much more effective treatment of cardiovascular disease and cancer have allowed many people who would have otherwise died in their 70s and 80s to live much longer. “I think what this means is that there is a substantial proportion of the population that has the biology to get to 100,” Dr. Perls said.

Perls said the Latino population and Blacks have a better track record than Whites in reaching the 100-year milestone. “The average life expectancy might be lower in these populations because of socioeconomic factors, but if they are able to get to around their early 80s, compared to Whites, their ability to get to 100 is actually better,” he said.

Asians fare best when it comes to longevity. While around 1% of White women in the United States live to 100, 10% of Asian women in Hong Kong hit that mark.

“I think some of that is better environment and health habits in Hong Kong than in the United States,” Dr. Perls said. “I think another piece may be a genetic advantage in East Asians. We’re looking into that.”

Dr. Perls said he agreed with Dr. Goel that health care providers and the lay public should not make assumptions on the basis of age alone as to how a person is doing. “People can age so very differently from one another,” he said.

Up to about age 90, the vast majority of those differences are determined by our health behaviors, such as smoking, alcohol use, exercise, sleep, the effect of our diets on weight, and access to good health care, including regular screening for problems such as high blood pressure, diabetes, and cancer. “People who are able to do everything right generally add healthy years to their lives, while those who do not have shorter life expectancies and longer periods of chronic diseases,” Dr. Perls said.

Paying diligent attention to these behaviors over the long run can have a huge payoff.

Dr. Perls’s team has found that to live beyond age 90 and on into the early 100s, protective genes can play a strong role. These genes help slow aging and decrease one’s risk for aging-related diseases. Centenarians usually have a history of aging very slowly and greatly delaying aging-related diseases and disability toward the ends of their lives.

Centenarians are the antithesis of the misguided belief that the older you get, the sicker you get. Quite the opposite occurs. For Dr. Perls, “the older you get, the healthier you’ve been.”
 

 

 

MD bias against the elderly?

Care of elderly patients is becoming essential in the practice of primary care physicians – but not all of them enjoy the work.

To be effective, physicians who treat centenarians must get a better idea of the individual patient’s functional status and comorbidities. “You absolutely cannot make assumptions on age alone,” Dr. Perls said.

The so-called “normal” temperature, 98.6° F, can spell trouble for centenarians and other very old patients, warned Natalie Baker, DNP, CRNP, an associate professor of nursing at the University of Alabama, Birmingham, and president of the 3,000-member Gerontological Advanced Practice Nurses Association.

“We have to be very cognizant of what we call a typical presentation of disease or illness and that a very subtle change in an older adult can signal a serious infection or illness,” Dr. Baker said. “If your patient has a high fever, that is a potential problem.”

The average temperature of an older adult is lower than the accepted 98.6° F, and their body’s response to an infection is slow to exhibit an increase in temperature, Dr. Baker said. “When treating centenarians, clinicians must be cognizant of other subtle signs of infection, such as decreased appetite or change in mentation,” she cautioned.

A decline in appetite or insomnia may be a subtle sign that these patients need to be evaluated, she added.
 

COVID-19 and centenarians

Three-quarters of the 1 million U.S. deaths from COVID-19 occurred in people aged 65 and older. However, Dr. Perls said centenarians may be a special subpopulation when it comes to COVID.

The Japanese Health Ministry, which follows the large centenarian population in that country, noted a marked jump in the number of centenarians during the pandemic – although the reasons for the increase aren’t clear.

Centenarians may be a bit different. Dr. Perls said some evidence suggests that the over-100 crowd may have better immune systems than younger people. “Part of the trick of getting to 100 is having a pretty good immune system,” he said.
 

Don’t mess with success

“There is no need at that point for us to try to alter their diet to what we think it might be,” Dr. Baker said. “There’s no need to start with diabetic education. They may tell you their secret is a shot of vodka every day. Why should we stop it at that age? Accept their lifestyles, because they’ve done something right to get to that age.”

Opinions differ on how to approach screening for centenarians.

Dr. Goel said guidelines for routine screening, such as colonoscopies, mammograms, and PAP smears, drop off for patients starting at 75. Dr. Perls said this strategy stems from the belief that people will die from other things first, so screening is no longer needed. Dr. Perls said he disagrees with this approach.

“Again, we can’t base our screening and health care decisions on age alone. If I have an independently functioning and robust 95-year-old man in my office, you can be sure I am going to continue recommending regular screening for colon cancer and other screenings that are normal for people who are 30 years younger,” he said.

Justin Zaghi, MD, chief medical officer at Heal, said screening patients in their late 90s and 100s for cancer generally doesn’t make sense except in some rare circumstances in which the cancer would be unlikely to be a cause of death. “However, if we are talking about screening for fall risks, hearing difficulties, poor vision, pain, and malnutrition, those screenings still absolutely make sense for patients in their late 90s and 100s,” Dr. Zaghi said.

One high-functioning 104-year-old patient of Dr. Perls underwent a total hip replacement for a hip fracture and is faring well. “Obviously, if she had end-stage dementia, we’d do everything to keep the person comfortable, or if they had medical problems that made surgery too high risk, then you don’t do it,” he said. “But if they’re otherwise, I would proceed.”
 

 

 

Avoid the ED

Dr. Goel said doctors should avoid sending patients to the emergency department, an often chaotic place that is especially unfriendly to centenarians and the very old. “Sometimes I’ve seen older patients who are being rushed to the ER, and I ask, What are the goals of care?” she said.

Clinicians caring for seniors should keep in mind that infections can cause seniors to appear confused – and this may lead the clinician to think the patient has dementia. Or, Dr. Goel said, a patient with dementia may suddenly experience much worse dementia.

“In either case, you want to make sure you’re not dealing with any underlying infection, like urinary tract infection, or pneumonia brewing, or skin infections,” she said. “Their skin is so much frailer. You want to make sure there are no bedsores.”

She has had patients whose children report that their usually placid centenarian parents are suddenly acting out. “We’ll do a urinary test and it definitely shows a urinary tract infection. You want to make sure you’re not missing out on something else before you attribute it to dementia,” she said.

Environmental changes, such as moving a patient to a new room in a hospital setting, can trigger an acute mental status change, such as delirium, she added. Helping older patients feel in control as much as possible is important.

“You want to make sure you’re orienting them to the time of day. Make sure they get up at the same time, go to bed at the same time, have clocks and calendars present – just making sure that they feel like they’re still in control of their body and their day,” she said.

Physicians should be aware of potential depression in these patients, whose experience of loss – an unavoidable consequence of outliving family and friends – can result in problems with sleep and diet, as well as a sense of social isolation.

Neal Flomenbaum, MD, professor and emergency physician-in-chief emeritus, New York–Presbyterian/Weill Cornell Medical Center in New York, said sometimes the best thing for these very elderly patients is to “get them in and out of ED as quickly as possible, and do what you can diagnostically.”

He noted that EDs have been making accommodations to serve the elderly, such as using LEDs that replicate outdoor lighting conditions, as well as providing seniors with separate rooms with glass doors to protect them from noise, separate air handlers to prevent infections, and adequate space for visitors.

These patients often are subject to trauma from falls.

“The bones don’t heal as well as in younger people, and treating their comorbidities is essential. Once they have trouble with one area and they’re lying in bed and can’t move much, they can get bedsores,” Dr. Flomenbaum said. “In the hospital, they are vulnerable to infections. So, you’re thinking of all of these things at the same time and how to treat them appropriately and then get them out of the hospital as soon as possible with whatever care that they need in their own homes if at all possible.”

“I always err on the side of less is more,” Dr. Goel said. “Obviously, if there is something – if they have a cough, they need an x-ray. That’s very basic. We want to take care of that. Give them the antibiotic if they need that. But rushing them in and out of the hospital doesn’t add to their quality of life.”

Dr. Flomenbaum, a pioneer in geriatric emergency medicine, says physicians need to be aware that centenarians and other very old patients don’t present the same way as younger adults.

He began to notice more than 20 years ago that every night, patients would turn up in his ED who were in their late 90s into their 100s. Some would come in with what their children identified as sudden-onset dementia – they didn’t know their own names and couldn’t identify their kids. They didn’t know the time or day. Dr. Flomenbaum said the children often asked whether their parents should enter a nursing home.

“And I’d say, ‘Not so fast. Well, let’s take a look at this.’ You don’t develop that kind of dementia overnight. It usually takes a while,” he said.

He said he ordered complete blood cell counts and oxygen saturation tests that frequently turned out to be abnormal. They didn’t have a fever, and infiltrates initially weren’t seen on chest x-rays.

With rehydration and supplemental oxygen, their symptoms started to improve, and it became obvious that the symptoms were not of dementia but of pneumonia, and that they required antibiotics, Dr. Flomenbaum said.
 

 

 

Dementia dilemma

Too often, on the basis of age, doctors assume patients have dementia or other cognitive impairments.

“What a shock and a surprise when doctors actually talk to folks and do a neurocognitive screen and find they’re just fine,” Dr. Perls said.

The decline in hearing and vision can lead to a misdiagnosis of cognitive impairment because the patients are not able to hear what you’re asking them. “It’s really important that the person can hear you – whether you use an amplifying device or they have hearing aids, that’s critical,” he said. “You just have to be a good doctor.”

Often the physical toll of aging exacerbates social difficulties. Poor hearing, for example, can accelerate cognitive impairment and cause people to interact less often, and less meaningfully, with their environment. For some, wearing hearing aids seems demeaning – until they hear what they’ve been missing.

“I get them to wear their hearing aids and, lo and behold, they’re a whole new person because they’re now able to take in their environment and interact with others,” Dr. Perls said.

Dr. Flomenbaum said alcohol abuse and drug reactions can cause delirium, which, unlike dementia, is potentially reversible. Yet many physicians cannot reliably differentiate between dementia and delirium, he added.

The geriatric specialists talk about the lessons they’ve learned and the gratification they get from caring for centenarians.

“I have come to realize the importance of family, of having a close circle, whether that’s through friends or neighbors,” Dr. Goel said. “This work is very rewarding because, if it wasn’t for homebound organizations, how would these people get care or get access to care?”

For Dr. Baker, a joy of the job is hearing centenarians share their life stories.

“I love to hear their stories about how they’ve overcome adversity, living through the depression and living through different wars,” she said. “I love talking to veterans, and I think that oftentimes, we do not value our older adults in our society as we should. Sometimes they are dismissed because they move slowly or are hard to communicate with due to hearing deficits. But they are, I think, a very important part of our lives.”
 

‘They’ve already won’

Most centenarians readily offer the secrets to their longevity. Aline Jacobsohn, of Boca Raton, Fla., is no different.

Ms. Jacobsohn, who will be 101 in October, thinks a diet of small portions of fish, vegetables, and fruit, which she has followed since her husband Leo died in 1982, has helped keep her healthy. She eats lots of salmon and herring and is a fan of spinach sautéed with olive oil. “The only thing I don’t eat is meat,” the trim and active Ms. Jacobsohn said in a recent interview over Zoom.

Her other secret: “Doctors. I like to stay away from them as much as possible.”

Shari Rosenbaum, MD, Jacobsohn’s internist, doesn’t dismiss that approach. She uses a version of it when managing her three centenarian patients, the oldest of whom is 103.

“Let them smoke! Let them drink! They’re happy. It’s not causing harm. Let them eat cake! They’ve already won,” said Dr. Rosenbaum, who is affiliated with Boca Raton–based MDVIP, a national membership-based network of 1,100 primary care physicians serving 368,000 patients. Of those, nearly 460 are centenarians.

“You’re not preventing those problems in this population,” she said. “They’re here to enjoy every moment that they have, and they might as well.”

Dr. Rosenbaum sees a divergence in her patients – those who will reach very old age, and those who won’t – starting in their 60s.

“The centenarians don’t have medical problems,” she said. “They don’t get cancer. They don’t get diabetes. Some of them take good care of themselves. Some don’t take such good care of themselves. But they are all optimists. They all see the glass half full. They all participate in life. They all have excellent support systems. They have good genes, a positive attitude toward life, and a strong social network.”

Ms. Jacobsohn – whose surname at the time was Bakst – grew up in Frankfurt am Main, Germany, during the rise of the Nazi regime. The family fled to Columbia in 1938, where she met and eventually married her husband, Leo, who ran a business importing clocks and watches in Cali.

In 1989, the Jacobsohns and their three children moved to south Florida to escape the dangers of kidnappings and ransoms posed by the drug cartels.

Ms. Jacobsohn agreed that she appears to have longevity genes – “good stock,” she calls it. “My mother died 23 days before she was 100. My grandmother lived till 99, almost 100,” she said.

Two years ago, she donated her car to a charity and stopped driving in the interest of her own safety and that of other drivers and pedestrians.

Ms. Jacobsohn has a strong support system. Two of her children live nearby and visit her nearly every day. A live-in companion helps her with the activities of daily life, including preparing meals.

Ms. Jacobsohn plays bridge regularly, and well. “I’m sorry to say that I’m a very good bridge player,” she said, frankly. “How is it possible that I’ve played bridge so well and then I don’t remember what I had for lunch yesterday?”

She reads, mainly a diet of history but occasionally novels, too. “They have to be engaging,” she said.

The loss of loved ones is an inevitable part of very old age. Her husband of 47 years died of emphysema, and one of her sons died in his 70s of prostate cancer.

She knows well the fate that awaits us all and accepts it philosophically.

“It’s a very normal thing that people die. You don’t live forever. So, whenever it comes, it’s okay. Enough is enough. Dayenu,” she said, using the Hebrew word for, “It would have been enough” – a favorite in the Passover Seder celebrating the ancient Jews’ liberation from slavery in Egypt.

Ms. Jacobsohn sang the song and then took a reporter on a Zoom tour of her tidy home and her large flower garden featuring Cattleya orchids from Colombia.

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

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Large study amplifies evidence of COVID vaccine safety in pregnancy

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Mon, 08/22/2022 - 08:59

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

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A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

A sweeping study of 85,000 infants found no link between mRNA COVID vaccination in pregnancy and greater risk of preterm birth, babies being born small for their gestational age, or stillbirth.

The research team wrote in the BMJ that their reassuring findings – drawn from a registry of all births in Ontario over an 8-month period – “can inform evidence-based decision-making” about COVID vaccination during pregnancy.

Previous research has found that pregnant patients are at higher risk of severe complications and death if they become infected with COVID and that vaccination before or during pregnancy prevents such outcomes and reduces the risk of newborn infection, noted Jeffrey Ecker, chief of obstetrics and gynecology at Massachusetts General Hospital, Boston.

This new study “adds to a growing body of information arguing clearly and reassuringly that vaccination during pregnancy is not associated with complications during pregnancy,” said Dr. Ecker, who was not involved in the new study.

He added that it “should help obstetric providers further reassure those who are hesitant that vaccination is safe and best both for the pregnant patient and their pregnancy.”
 

Methods and results

For the new study, researchers tapped a provincial registry of all live and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500 g. Unique health card numbers were used to link birth records to a database of COVID vaccinations.

Of 85,162 infants born from May through December of 2021, 43,099 (50.6%) were born to individuals who received at least one vaccine dose during pregnancy. Among those, 99.7% received an mRNA vaccine such as Pfizer-BioNTech or Moderna.

Vaccination during pregnancy was not associated with greater risk of overall preterm birth (6.5% among vaccinated individuals versus 6.9% among unvaccinated; hazard ratio, 1.02; 95% confidence interval, 0.96-1.08), spontaneous preterm birth (3.7% versus 4.4%; hazard ratio, 0.96; 95% CI, 0.90-1.03) or very preterm birth (0.59% versus 0.89%; hazard ratio, 0.80; 95% CI, 0.67-0.95).

Likewise, no increase was observed in the risk of an infant being small for gestational age at birth (9.1% versus 9.2%; hazard ratio, 0.98; 95% CI, 0.93-1.03).

The researchers observed a reduction in the risk of stillbirth, even after adjusting for potential confounders. Stillbirths occurred in 0.25% of vaccinated individuals, compared with 0.44% of unvaccinated individuals (hazard ratio, 0.65; 95% CI, 0.51-0.84).

A reduced risk of stillbirth – albeit to a smaller degree – was also found in a Scandinavian registry study that included 28,506 babies born to individuals who were vaccinated during pregnancy.

“Collectively, the findings from these two studies are reassuring and are consistent with no increased risk of stillbirth after COVID-19 vaccination during pregnancy. In contrast, COVID-19 disease during pregnancy has been associated with an increased risk of stillbirth,” the researchers wrote.

Findings did not vary by which mRNA vaccine a mother received, the number of doses she received, or the trimester in which a vaccine was given, the researchers reported.
 

Stillbirth findings will be ‘very reassuring’ for patients

The lead investigator, Deshayne Fell, PhD, said in an interview, the fact that the study comprised the entire population of pregnant people in Ontario during the study period “increases our confidence” about the validity and relevance of the findings for other geographic settings.

Dr. Fell, an associate professor in epidemiology and public health at the University of Ottawa and a scientist at the Children’s Hospital of Eastern Ontario Research Institute, Ottawa, said the evaluation of stillbirth in particular, “a rare but devastating outcome,” will be “very reassuring and useful for clinical counseling.”

A limitation cited by the research team included a lack of data on vaccination prior to pregnancy.

In the new study, Dr, Ecker said, “Though the investigators were able to adjust for many variables they cannot be certain that some unmeasured variable that, accordingly, was not adjusted for does not hide a small risk. This seems very unlikely, however.”

The Canadian research team said similar studies of non-mRNA COVID vaccines “should be a research priority.” However, such studies are not underway in Canada, where only mRNA vaccines are used in pregnancy, Dr. Fell said.

This study was supported by the Public Health Agency of Canada.

Dr. Fell and Dr. Ecker reported no competing financial interests.

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Exercise limitations in COPD – not everyone needs more inhalers

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Changed
Fri, 08/19/2022 - 07:47

Chronic obstructive pulmonary disease (COPD) is defined by airway obstruction and alveolar damage caused by exposure to noxious air particles. The physiologic results include varying degrees of gas-exchange abnormality and mechanical respiratory limitation, often in the form of dynamic hyperinflation. There’s a third major contributor, though – skeletal muscle deconditioning. Only one of these abnormalities responds to inhalers.

When your patients with COPD report dyspnea or exercise intolerance, what do you do? Do you attempt to determine its character to pinpoint its origin? Do you quiz them about their baseline activity levels to quantify their conditioning? I bet you get right to the point and order a cardiopulmonary exercise test (CPET). That way you’ll be able to tease out all the contributors. Nah. Most likely you add an inhaler before continuing to rush through your COPD quality metrics: Vaccines? Check. Lung cancer screening? Check. Smoking cessation? Check.

The physiology of dyspnea and exercise limitation in COPD has been extensively studied. Work-of-breathing, dynamic hyperinflation, and gas-exchange inefficiencies interact with each other in complex ways to produce symptoms. The presence of deconditioning simply magnifies the existing abnormalities within the respiratory system by creating more strain at lower work rates. Acute exacerbations (AECOPD) and oral corticosteroids further aggravate skeletal muscle dysfunction.

The Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) Report directs clinicians to use inhalers to manage dyspnea. If they’re already on one inhaler, they get another. This continues until they’re stabilized on a long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS). The GOLD report also advises pulmonary rehabilitation for any patient with grade B through D disease. Unfortunately, the pulmonary rehabilitation recommendation is buried in the text and doesn’t appear within the popularized pharmacologic algorithms in the report’s figures.

The data for adding inhalers on top of each other to reduce AECOPD and improve overall quality of life (QOL) are good. However, although GOLD tells us to keep adding inhalers for the dyspneic patient with COPD, the authors acknowledge that this hasn’t been systematically tested. It’s important to remember that GOLD is a “statement” as opposed to a clinical practice guideline. The difference? A statement doesn’t require the same formal, rigorous scientific analysis known as the GRADE approach. Using this kind of analysis, a recent clinical practice guideline by the American Thoracic Society found no benefit in dyspnea or respiratory QOL with step-up from inhaler monotherapy.

Inhalers won’t do anything for gas-exchange inefficiencies and deconditioning, at least not directly. A recent CPET study from the CanCOLD network found ventilatory inefficiency in 23% of GOLD 1 and 26% of GOLD 2-4 COPD patients. The numbers were higher for those who reported dyspnea. Skeletal muscle dysfunction rates are equally high.

Thus, dyspnea and exercise intolerance are major determinants of QOL in COPD, but inhalers will only get you so far. At a minimum, make sure you get an activity/exercise history from your patients with COPD. For those who are sedentary, provide an exercise prescription (really, it’s not that hard to do). If dyspnea persists despite LABA or LAMA monotherapy, clarify the complaint before doubling down. Finally, try to get the patient into a good pulmonary rehabilitation program. They’ll thank you afterwards.

Dr. Holley is Associate Professor, department of medicine, Uniformed Services University of the Health Sciences and Program Director, Pulmonary and Critical Care Medical Fellowship, department of medicine, Walter Reed National Military Medical Center, both in Bethesda, Md. He reported receiving research grants from Fisher-Paykel and receiving income from the American College of Chest Physicians.

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

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Chronic obstructive pulmonary disease (COPD) is defined by airway obstruction and alveolar damage caused by exposure to noxious air particles. The physiologic results include varying degrees of gas-exchange abnormality and mechanical respiratory limitation, often in the form of dynamic hyperinflation. There’s a third major contributor, though – skeletal muscle deconditioning. Only one of these abnormalities responds to inhalers.

When your patients with COPD report dyspnea or exercise intolerance, what do you do? Do you attempt to determine its character to pinpoint its origin? Do you quiz them about their baseline activity levels to quantify their conditioning? I bet you get right to the point and order a cardiopulmonary exercise test (CPET). That way you’ll be able to tease out all the contributors. Nah. Most likely you add an inhaler before continuing to rush through your COPD quality metrics: Vaccines? Check. Lung cancer screening? Check. Smoking cessation? Check.

The physiology of dyspnea and exercise limitation in COPD has been extensively studied. Work-of-breathing, dynamic hyperinflation, and gas-exchange inefficiencies interact with each other in complex ways to produce symptoms. The presence of deconditioning simply magnifies the existing abnormalities within the respiratory system by creating more strain at lower work rates. Acute exacerbations (AECOPD) and oral corticosteroids further aggravate skeletal muscle dysfunction.

The Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) Report directs clinicians to use inhalers to manage dyspnea. If they’re already on one inhaler, they get another. This continues until they’re stabilized on a long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS). The GOLD report also advises pulmonary rehabilitation for any patient with grade B through D disease. Unfortunately, the pulmonary rehabilitation recommendation is buried in the text and doesn’t appear within the popularized pharmacologic algorithms in the report’s figures.

The data for adding inhalers on top of each other to reduce AECOPD and improve overall quality of life (QOL) are good. However, although GOLD tells us to keep adding inhalers for the dyspneic patient with COPD, the authors acknowledge that this hasn’t been systematically tested. It’s important to remember that GOLD is a “statement” as opposed to a clinical practice guideline. The difference? A statement doesn’t require the same formal, rigorous scientific analysis known as the GRADE approach. Using this kind of analysis, a recent clinical practice guideline by the American Thoracic Society found no benefit in dyspnea or respiratory QOL with step-up from inhaler monotherapy.

Inhalers won’t do anything for gas-exchange inefficiencies and deconditioning, at least not directly. A recent CPET study from the CanCOLD network found ventilatory inefficiency in 23% of GOLD 1 and 26% of GOLD 2-4 COPD patients. The numbers were higher for those who reported dyspnea. Skeletal muscle dysfunction rates are equally high.

Thus, dyspnea and exercise intolerance are major determinants of QOL in COPD, but inhalers will only get you so far. At a minimum, make sure you get an activity/exercise history from your patients with COPD. For those who are sedentary, provide an exercise prescription (really, it’s not that hard to do). If dyspnea persists despite LABA or LAMA monotherapy, clarify the complaint before doubling down. Finally, try to get the patient into a good pulmonary rehabilitation program. They’ll thank you afterwards.

Dr. Holley is Associate Professor, department of medicine, Uniformed Services University of the Health Sciences and Program Director, Pulmonary and Critical Care Medical Fellowship, department of medicine, Walter Reed National Military Medical Center, both in Bethesda, Md. He reported receiving research grants from Fisher-Paykel and receiving income from the American College of Chest Physicians.

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

Chronic obstructive pulmonary disease (COPD) is defined by airway obstruction and alveolar damage caused by exposure to noxious air particles. The physiologic results include varying degrees of gas-exchange abnormality and mechanical respiratory limitation, often in the form of dynamic hyperinflation. There’s a third major contributor, though – skeletal muscle deconditioning. Only one of these abnormalities responds to inhalers.

When your patients with COPD report dyspnea or exercise intolerance, what do you do? Do you attempt to determine its character to pinpoint its origin? Do you quiz them about their baseline activity levels to quantify their conditioning? I bet you get right to the point and order a cardiopulmonary exercise test (CPET). That way you’ll be able to tease out all the contributors. Nah. Most likely you add an inhaler before continuing to rush through your COPD quality metrics: Vaccines? Check. Lung cancer screening? Check. Smoking cessation? Check.

The physiology of dyspnea and exercise limitation in COPD has been extensively studied. Work-of-breathing, dynamic hyperinflation, and gas-exchange inefficiencies interact with each other in complex ways to produce symptoms. The presence of deconditioning simply magnifies the existing abnormalities within the respiratory system by creating more strain at lower work rates. Acute exacerbations (AECOPD) and oral corticosteroids further aggravate skeletal muscle dysfunction.

The Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) Report directs clinicians to use inhalers to manage dyspnea. If they’re already on one inhaler, they get another. This continues until they’re stabilized on a long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS). The GOLD report also advises pulmonary rehabilitation for any patient with grade B through D disease. Unfortunately, the pulmonary rehabilitation recommendation is buried in the text and doesn’t appear within the popularized pharmacologic algorithms in the report’s figures.

The data for adding inhalers on top of each other to reduce AECOPD and improve overall quality of life (QOL) are good. However, although GOLD tells us to keep adding inhalers for the dyspneic patient with COPD, the authors acknowledge that this hasn’t been systematically tested. It’s important to remember that GOLD is a “statement” as opposed to a clinical practice guideline. The difference? A statement doesn’t require the same formal, rigorous scientific analysis known as the GRADE approach. Using this kind of analysis, a recent clinical practice guideline by the American Thoracic Society found no benefit in dyspnea or respiratory QOL with step-up from inhaler monotherapy.

Inhalers won’t do anything for gas-exchange inefficiencies and deconditioning, at least not directly. A recent CPET study from the CanCOLD network found ventilatory inefficiency in 23% of GOLD 1 and 26% of GOLD 2-4 COPD patients. The numbers were higher for those who reported dyspnea. Skeletal muscle dysfunction rates are equally high.

Thus, dyspnea and exercise intolerance are major determinants of QOL in COPD, but inhalers will only get you so far. At a minimum, make sure you get an activity/exercise history from your patients with COPD. For those who are sedentary, provide an exercise prescription (really, it’s not that hard to do). If dyspnea persists despite LABA or LAMA monotherapy, clarify the complaint before doubling down. Finally, try to get the patient into a good pulmonary rehabilitation program. They’ll thank you afterwards.

Dr. Holley is Associate Professor, department of medicine, Uniformed Services University of the Health Sciences and Program Director, Pulmonary and Critical Care Medical Fellowship, department of medicine, Walter Reed National Military Medical Center, both in Bethesda, Md. He reported receiving research grants from Fisher-Paykel and receiving income from the American College of Chest Physicians.

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

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Lung adverse effects in patients taking trastuzumab deruxtecan

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Wed, 01/04/2023 - 17:16

Lung disease as an adverse effect of the targeted cancer drug trastuzumab deruxtecan (T-DXd, Enhertu) is not negligible, although the benefit-to-risk relationship with use of the drug is still positive, say researchers who report a review of early clinical trials with the drug.

T-DXd is a monoclonal antibody that targets HER2. It is approved for use in HER2-positive breast, gastric, and lung cancers.

In the new study, investigators analyzed data from early clinical trials that involved patients with advanced cancers who had been heavily pretreated. They found an incidence of just over 15% for interstitial lung disease (ILD)/pneumonitis associated with the drug. Most patients (77.4%) had grade 1 or 2 ILD, but 2.2% of patients had grade 5 ILD.

“Interstitial lung disease is a known risk factor in patients treated with antibody conjugates for cancer,” commented lead author Charles Powell, MD, Icahn School of Medicine at Mount Sinai, New York. This adverse effect can lead to lung fibrosis and can become severe, life threatening, and even fatal, the authors warned.

The authors also discussed management of the event, which involves corticosteroids, and recommended that any patient who develops ILD of grade 3 or higher be hospitalized.

Close monitoring and proactive management may reduce the risk of ILD, they suggested.

Indeed, the incidence of this adverse effect was lower in a later phase 3 trial of the drug (10.5% in the DESTINY-Breast03 trial) and that the adverse events were less severe in this patient population (none of these events were of grade 4 or 5).

“Increased knowledge ... and implementation of ILD/pneumonitis monitoring, diagnosis, and management guidelines” may have resulted in this adverse effect being identified early and treated before it progressed, they commented.

ILD is highlighted in a boxed warning on the product label.

The study was published online in ESMO Open.

In their review, the investigators evaluated nine early-stage monotherapy clinical trials (phases 1 and 2) involving a total of 1,150 patients (breast cancer, 44.3%; gastric cancer, 25.6%; lung cancer, 17.7%; colorectal cancer, 9.3%, other cancers, 3.0%).

These patients had advanced cancer and had been heavily pretreated with a median of four prior lines of therapy. They received one or more doses of at least 5.4 mg/kg of T-DXd.

Nearly half of the cohort were treated for more than 6 months. A total of 276 potential ILD/pneumonitis events were sent for adjudication; of those, 85% were adjudicated as ILD/pneumonitis.

The overall incidence of adjudicated ILD/pneumonitis events was 15.4%; most were low-grade events. Some 87% of patients experienced their first ILD event within 12 months of treatment. The median time to experiencing an ILD/pneumonitis event was 5.4 months.

Some of the patients who developed grade 1 ILD/pneumonitis were treated and the adverse event resolved. These patients were then rechallenged with the drug. Only 3 of the 47 rechallenged patients experienced recurrence of ILD/pneumonitis, the authors noted.

“Rechallenge with T-DXd after complete resolution of grade 1 events is possible and warrants further investigation,” they commented. They cautioned, however, that rechallenge is not recommended for all patients, at least not for those with grade 2 or higher ILD/pneumonitis.

Overall, the authors concluded that the “benefit-risk of T-DXd treatment is positive,” but they warned that some patients may be at increased risk of developing ILD/pneumonitis

Baseline factors that increase the risk of developing an ILD/pneumonitis event include the following: being younger than 65 years, receiving a T-DXd dose of more than6.4 mg/kg, having a baseline oxygen saturation level of less than 95%, having moderate to severe renal impairment, and having lung comorbidities. In addition, patients who had initially been diagnosed with cancer more than 4 years before receiving the drug were at higher risk of developing ILD/pneumonitis.

“Using learnings from the early clinical trials experience, physician education and patient management protocols were revised and disseminated by the study sponsors [and] more recent trial data in earlier lines of therapy has demonstrated lower rates of ILD events, suggesting close monitoring and proactive management of ILD/pneumonitis is warranted for all patients,” Dr. Powell said in a statement.

The T-DXd clinical trials were sponsored by AstraZeneca and Daiichi Sankyo. Dr. Powell has received fees from Daiichi Sankyo, AstraZeneca, and Voluntis.

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

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Lung disease as an adverse effect of the targeted cancer drug trastuzumab deruxtecan (T-DXd, Enhertu) is not negligible, although the benefit-to-risk relationship with use of the drug is still positive, say researchers who report a review of early clinical trials with the drug.

T-DXd is a monoclonal antibody that targets HER2. It is approved for use in HER2-positive breast, gastric, and lung cancers.

In the new study, investigators analyzed data from early clinical trials that involved patients with advanced cancers who had been heavily pretreated. They found an incidence of just over 15% for interstitial lung disease (ILD)/pneumonitis associated with the drug. Most patients (77.4%) had grade 1 or 2 ILD, but 2.2% of patients had grade 5 ILD.

“Interstitial lung disease is a known risk factor in patients treated with antibody conjugates for cancer,” commented lead author Charles Powell, MD, Icahn School of Medicine at Mount Sinai, New York. This adverse effect can lead to lung fibrosis and can become severe, life threatening, and even fatal, the authors warned.

The authors also discussed management of the event, which involves corticosteroids, and recommended that any patient who develops ILD of grade 3 or higher be hospitalized.

Close monitoring and proactive management may reduce the risk of ILD, they suggested.

Indeed, the incidence of this adverse effect was lower in a later phase 3 trial of the drug (10.5% in the DESTINY-Breast03 trial) and that the adverse events were less severe in this patient population (none of these events were of grade 4 or 5).

“Increased knowledge ... and implementation of ILD/pneumonitis monitoring, diagnosis, and management guidelines” may have resulted in this adverse effect being identified early and treated before it progressed, they commented.

ILD is highlighted in a boxed warning on the product label.

The study was published online in ESMO Open.

In their review, the investigators evaluated nine early-stage monotherapy clinical trials (phases 1 and 2) involving a total of 1,150 patients (breast cancer, 44.3%; gastric cancer, 25.6%; lung cancer, 17.7%; colorectal cancer, 9.3%, other cancers, 3.0%).

These patients had advanced cancer and had been heavily pretreated with a median of four prior lines of therapy. They received one or more doses of at least 5.4 mg/kg of T-DXd.

Nearly half of the cohort were treated for more than 6 months. A total of 276 potential ILD/pneumonitis events were sent for adjudication; of those, 85% were adjudicated as ILD/pneumonitis.

The overall incidence of adjudicated ILD/pneumonitis events was 15.4%; most were low-grade events. Some 87% of patients experienced their first ILD event within 12 months of treatment. The median time to experiencing an ILD/pneumonitis event was 5.4 months.

Some of the patients who developed grade 1 ILD/pneumonitis were treated and the adverse event resolved. These patients were then rechallenged with the drug. Only 3 of the 47 rechallenged patients experienced recurrence of ILD/pneumonitis, the authors noted.

“Rechallenge with T-DXd after complete resolution of grade 1 events is possible and warrants further investigation,” they commented. They cautioned, however, that rechallenge is not recommended for all patients, at least not for those with grade 2 or higher ILD/pneumonitis.

Overall, the authors concluded that the “benefit-risk of T-DXd treatment is positive,” but they warned that some patients may be at increased risk of developing ILD/pneumonitis

Baseline factors that increase the risk of developing an ILD/pneumonitis event include the following: being younger than 65 years, receiving a T-DXd dose of more than6.4 mg/kg, having a baseline oxygen saturation level of less than 95%, having moderate to severe renal impairment, and having lung comorbidities. In addition, patients who had initially been diagnosed with cancer more than 4 years before receiving the drug were at higher risk of developing ILD/pneumonitis.

“Using learnings from the early clinical trials experience, physician education and patient management protocols were revised and disseminated by the study sponsors [and] more recent trial data in earlier lines of therapy has demonstrated lower rates of ILD events, suggesting close monitoring and proactive management of ILD/pneumonitis is warranted for all patients,” Dr. Powell said in a statement.

The T-DXd clinical trials were sponsored by AstraZeneca and Daiichi Sankyo. Dr. Powell has received fees from Daiichi Sankyo, AstraZeneca, and Voluntis.

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

Lung disease as an adverse effect of the targeted cancer drug trastuzumab deruxtecan (T-DXd, Enhertu) is not negligible, although the benefit-to-risk relationship with use of the drug is still positive, say researchers who report a review of early clinical trials with the drug.

T-DXd is a monoclonal antibody that targets HER2. It is approved for use in HER2-positive breast, gastric, and lung cancers.

In the new study, investigators analyzed data from early clinical trials that involved patients with advanced cancers who had been heavily pretreated. They found an incidence of just over 15% for interstitial lung disease (ILD)/pneumonitis associated with the drug. Most patients (77.4%) had grade 1 or 2 ILD, but 2.2% of patients had grade 5 ILD.

“Interstitial lung disease is a known risk factor in patients treated with antibody conjugates for cancer,” commented lead author Charles Powell, MD, Icahn School of Medicine at Mount Sinai, New York. This adverse effect can lead to lung fibrosis and can become severe, life threatening, and even fatal, the authors warned.

The authors also discussed management of the event, which involves corticosteroids, and recommended that any patient who develops ILD of grade 3 or higher be hospitalized.

Close monitoring and proactive management may reduce the risk of ILD, they suggested.

Indeed, the incidence of this adverse effect was lower in a later phase 3 trial of the drug (10.5% in the DESTINY-Breast03 trial) and that the adverse events were less severe in this patient population (none of these events were of grade 4 or 5).

“Increased knowledge ... and implementation of ILD/pneumonitis monitoring, diagnosis, and management guidelines” may have resulted in this adverse effect being identified early and treated before it progressed, they commented.

ILD is highlighted in a boxed warning on the product label.

The study was published online in ESMO Open.

In their review, the investigators evaluated nine early-stage monotherapy clinical trials (phases 1 and 2) involving a total of 1,150 patients (breast cancer, 44.3%; gastric cancer, 25.6%; lung cancer, 17.7%; colorectal cancer, 9.3%, other cancers, 3.0%).

These patients had advanced cancer and had been heavily pretreated with a median of four prior lines of therapy. They received one or more doses of at least 5.4 mg/kg of T-DXd.

Nearly half of the cohort were treated for more than 6 months. A total of 276 potential ILD/pneumonitis events were sent for adjudication; of those, 85% were adjudicated as ILD/pneumonitis.

The overall incidence of adjudicated ILD/pneumonitis events was 15.4%; most were low-grade events. Some 87% of patients experienced their first ILD event within 12 months of treatment. The median time to experiencing an ILD/pneumonitis event was 5.4 months.

Some of the patients who developed grade 1 ILD/pneumonitis were treated and the adverse event resolved. These patients were then rechallenged with the drug. Only 3 of the 47 rechallenged patients experienced recurrence of ILD/pneumonitis, the authors noted.

“Rechallenge with T-DXd after complete resolution of grade 1 events is possible and warrants further investigation,” they commented. They cautioned, however, that rechallenge is not recommended for all patients, at least not for those with grade 2 or higher ILD/pneumonitis.

Overall, the authors concluded that the “benefit-risk of T-DXd treatment is positive,” but they warned that some patients may be at increased risk of developing ILD/pneumonitis

Baseline factors that increase the risk of developing an ILD/pneumonitis event include the following: being younger than 65 years, receiving a T-DXd dose of more than6.4 mg/kg, having a baseline oxygen saturation level of less than 95%, having moderate to severe renal impairment, and having lung comorbidities. In addition, patients who had initially been diagnosed with cancer more than 4 years before receiving the drug were at higher risk of developing ILD/pneumonitis.

“Using learnings from the early clinical trials experience, physician education and patient management protocols were revised and disseminated by the study sponsors [and] more recent trial data in earlier lines of therapy has demonstrated lower rates of ILD events, suggesting close monitoring and proactive management of ILD/pneumonitis is warranted for all patients,” Dr. Powell said in a statement.

The T-DXd clinical trials were sponsored by AstraZeneca and Daiichi Sankyo. Dr. Powell has received fees from Daiichi Sankyo, AstraZeneca, and Voluntis.

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

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Guidelines: Convalescent plasma not recommended for most hospitalized with COVID

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Wed, 08/17/2022 - 14:58

 

The Association for the Advancement of Blood and Biotherapies has released clinical practice guidelines for using COVID-19 convalescent plasma (CCP) in hospital and outpatient settings.

In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”

The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:

  • Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
  • CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
  • CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
  • Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
  • The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)

Multiple guidelines for use of CCP are similar

In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.

They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.

The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.

The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.

“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.

“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.

Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”

One strong recommendation

Dr. Barrett pointed out that four of the five recommendations are rated “weak.”

“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”

She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.

“That clinical bottom line is what most clinicians will look for,” she said.

“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”

The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.

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The Association for the Advancement of Blood and Biotherapies has released clinical practice guidelines for using COVID-19 convalescent plasma (CCP) in hospital and outpatient settings.

In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”

The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:

  • Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
  • CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
  • CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
  • Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
  • The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)

Multiple guidelines for use of CCP are similar

In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.

They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.

The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.

The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.

“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.

“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.

Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”

One strong recommendation

Dr. Barrett pointed out that four of the five recommendations are rated “weak.”

“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”

She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.

“That clinical bottom line is what most clinicians will look for,” she said.

“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”

The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.

 

The Association for the Advancement of Blood and Biotherapies has released clinical practice guidelines for using COVID-19 convalescent plasma (CCP) in hospital and outpatient settings.

In summarizing the practice statement, the authors write, “CCP is most effective when transfused with high neutralizing titers early after symptom onset.”

The five guidelines, were published in Annals of Internal Medicine. The guidelines and strength of recommendations are:

  • Nonhospitalized patients at high risk for disease progression should have CCP transfusion in addition to usual standard of care. (weak)
  • CCP transfusion should not be done for unselected hospitalized patients with moderate or severe disease. This does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. (strong)
  • CCP transfusion is suggested in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies at admission. (weak)
  • Prophylactic CCP transfusion is not recommended for uninfected people with close contact exposure to someone with COVID-19. (weak)
  • The AABB suggests CCP transfusion along with standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression. (weak)

Multiple guidelines for use of CCP are similar

In an accompanying editorial, Jason V. Baker, MD, MS, and H. Clifford Lane, MD, who are part of the National Institutes of Health Treatment Guidelines Panel, say guidelines from that organization around CCP generally align with those of the AABB and the Infectious Diseases Society of America.

They all note CCP’s potential for helping immunocompromised patients and they recommend against CCP in unselected, hospitalized patients.

The main difference is that the AABB also “suggests” using CCP in combination with other standard treatments for outpatients at high risk for disease progression, regardless of their immune status, write Dr. Baker, who is with Hennepin Healthcare and the department of medicine at the University of Minnesota in Minneapolis, and Dr. Lane, who is with the National Institutes of Health.

The precise circumstance for recommending CCP remains unclear, Dr. Baker and Dr. Lane write. That’s because most available evidence has come in the absence of vaccines and antiviral agents, including nirmatrelvir–ritonavir (Paxlovid), they explain.

“At this point in the pandemic, it seems that the patient most likely to benefit from passive antibody therapy is the immunocompromised host with COVID-19 who cannot mount their own antibody response to vaccine or prior infection,” they write.

“In that setting, and in the absence of other antiviral treatments or progression despite receipt of standard treatments, high-titer CCP from a recently recovered donor is a reasonable approach,” they conclude.

Eileen Barrett, MD, MPH, an assistant professor in the division of hospital medicine at the University of New Mexico in Albuquerque, said in an interview that “clinical guidelines like this really help practicing physicians as we navigate the explosion of research findings since the start of the pandemic.”

One strong recommendation

Dr. Barrett pointed out that four of the five recommendations are rated “weak.”

“The weak recommendations for convalescent plasma in most situations is very humbling,” she said, “particularly as we recall the earliest days of the pandemic when many hospitalized patients received this treatment when little was known about what could help.”

She highlighted the paper’s only strong recommendation, which was against convalescent plasma use for the vast majority of hospitalized patients with COVID.

“That clinical bottom line is what most clinicians will look for,” she said.

“Similarly,” she said, “the accompanying editorial is so helpful in reminding the reader that, despite some possible benefit to convalescent plasma in a smaller subgroup of patients, variant-appropriate monoclonal antibodies and antivirals are better options.”

The disclosures for lead author of the guidelines, Lise J. Estcourt, MB BChir, DPhil, with the National Health Service Blood and Transplant Department and Radcliffe department of medicine at the University of Oxford (England) and her colleagues are available at https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-1079. The editorialists and Dr. Barrett declare no relevant financial relationships.

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Trials data on COPD leave primary care docs in the dark

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Changed
Mon, 08/15/2022 - 15:51

Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.

As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.

Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.

“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”

Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.

The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.

Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
 

A window onto patient burden

According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.

The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.

Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.

Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.

Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.

Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.

Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.

The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”

Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.

At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.

Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.

Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.

Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.

Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.

Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.

Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.

According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.

“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”

The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.

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

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Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.

As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.

Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.

“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”

Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.

The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.

Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
 

A window onto patient burden

According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.

The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.

Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.

Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.

Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.

Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.

Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.

The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”

Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.

At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.

Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.

Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.

Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.

Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.

Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.

Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.

According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.

“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”

The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.

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

Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.

As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.

Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.

“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”

Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.

The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.

Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
 

A window onto patient burden

According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.

The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.

Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.

Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.

Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.

Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.

Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.

The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”

Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.

At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.

Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.

Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.

Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.

Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.

Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.

Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.

According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.

“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”

The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.

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

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NYC switching children’s COVID vaccine sites to monkeypox

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Mon, 08/15/2022 - 15:09

New York City is closing 10 city-run sites where children younger than 5 could get the COVID-19 vaccine, with three of those sites transitioning to administer the monkeypox vaccine.

The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.

“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”

All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.

No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.

Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.

“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8

Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.

According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.

On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.

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

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New York City is closing 10 city-run sites where children younger than 5 could get the COVID-19 vaccine, with three of those sites transitioning to administer the monkeypox vaccine.

The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.

“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”

All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.

No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.

Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.

“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8

Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.

According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.

On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.

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

New York City is closing 10 city-run sites where children younger than 5 could get the COVID-19 vaccine, with three of those sites transitioning to administer the monkeypox vaccine.

The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.

“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”

All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.

No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.

Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.

“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8

Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.

According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.

On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.

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

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After ‘a Lot of Doors Shut in Our Face,’ Crusading Couple Celebrate Passage of Burn Pit Bill

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Changed
Fri, 08/12/2022 - 12:01

 

The battle was just beginning for Le Roy Torres and his wife, Rosie, when the Army captain returned to Texas in 2008, already starting to suffer from the toxic substances he’d inhaled from the 10-acre burn pit at Camp Anaconda in Balad, Iraq.

Along the way, Le Roy would lose the job he loved as a Texas state trooper and take his fight all the way to a Supreme Court victory. He would be rushed to the emergency room hundreds of times, be denied health benefits by the Department of Veterans Affairs for years, attempt suicide, and seek experimental cures for the damage done to his lungs and brain.

Amid all that, Le Roy and Rosie founded an organization to help others and push Congress to fix the laws that allowed the suffering of veterans to go on, and ultimately enlist people like comedian and activist Jon Stewart, who helped them win a dramatic showdown in the Senate last week.

Their struggle will never really be over. But the Torreses’ campaign to make sure no other veterans experience what they had to ends Aug. 10, when they are set to join President Joe Biden as he signs a law to guarantee that 3.5 million American warriors exposed to similar hazards can get care.

“I mean, to think that 13 years ago we were walking the halls [of Congress] — it’s really emotional,” Rosie said recently, halting to collect herself and wipe back tears, “because I think of all the people that died along the way.”

The bill provides a new entitlement program for veterans who served in a combat zone in the past 32 years. If they are diagnosed with any of 23 conditions identified in the legislation — ranging from specific cancers to breathing ailments — they would be deemed automatically eligible for health coverage. The Congressional Budget Office estimated the new benefits would cost $280 billion over the next 10 years.

Most veterans — nearly 80% — who start experiencing symptoms after leaving the service get denied what’s known as a service connection when they seek help from the VA. The system has been designed to disbelieve them, the veterans complain. They must prove their breathing problems or cancers came from the toxic trash smoke they breathed overseas, which is extremely difficult.

When Le Roy returned home from Balad Air Base — the second-largest U.S. post in Iraq and where the military incinerated tons of debris daily, including plastic, ammunition, and medical waste — he was already sick. He was rushed to the hospital a few weeks later with a severe respiratory infection.

He had expected to keep working as a state trooper, but by 2010 it was clear he couldn’t perform all the duties because of his illness. When he asked for a different job with the Texas Department of Public Safety, he was denied. He was told he had to resign if he wanted to apply for medical retirement. The retirement request was then rejected. So he sued and eventually took the case to the Supreme Court, which in June ruled that states were not immune from such lawsuits by service members.

In those early years, the military and VA doctors couldn’t say what caused his breathing problems and splitting headaches. As with other victims of toxic exposure, diagnoses proved to be difficult. Some doctors suggested the problems weren’t real — a pronouncement often encountered by other vets whose claims are denied.

Like so many others, Rosie turned to the internet for information she couldn’t get from the VA, where she had worked for 23 years. She discovered a Facebook group that she would use as the basis for a new advocacy group, Burn Pits 360.

Le Roy was ultimately diagnosed with constrictive bronchiolitis, fibrosis of the lungs, and toxic encephalopathy. He eventually got his benefits in early 2013. By then, the family was deep in debt.

For years he lived with the reality that the military he had served for 23 years refused to answer his needs, and the police force he loved didn’t seem to care.

“It’s something that we have now learned is known as moral injury and compound loss,” Rosie said.

As a man, he began to wonder how he could provide for his family, if he was any use to anyone, she added. “So then that led to him attempting to take his life.”

It also led the couple and parents of three to beseech Congress to fix the problems. They started walking the halls in the Capitol. Success there was not any easier.

“We came to Capitol Hill and just handed out information we had printed about burn pit exposure,” Le Roy said at his last visit to the Hill in June, an oxygen tube strung under his nose.

“There were a lot of doors shut in our face,” Rosie said.

 

 

While making little progress in Congress, they built Burn Pits 360 into an advocacy group and a clearinghouse to help other veterans similarly frustrated by a system that seemed to be failing them.

The breakthrough for Rosie began when she saw Stewart and 9/11 survivors’ advocate John Feal winning a similar battle to make Congress fully fund health and compensation programs for responders of the Sept. 11, 2001, terror attacks. She recalls reading up on the toxic substances in the dust and smoke that spewed from the collapsed twin towers and discovering they were remarkably similar to the poisons inhaled by troops near the waste fires that were also set ablaze with jet fuel.

She called Feal. Feal called Stewart, and by February 2019 the four of them were meeting on Capitol Hill with lawmakers, including Sen. Kirsten Gillibrand (D-N.Y.), one of the authors of the 9/11 legislation.

The key, they decided in those first meetings, was to remove the obstacles for the most common illnesses and eliminate the burden of proof on ill former soldiers. Gillibrand’s office wrote that bill, along with Rep. Raul Ruiz (D-Calif.), who championed it in the House.

Related Links

Ultimately, that bill became the heart of the measure that passed, known as the PACT Act and named for a soldier who died from cancer linked to his service.

“Our bill was the first federal presumption for burn pits coverage ever. And that was all because of Rosie and Le Roy,” said Gillibrand.

But just as with the 9/11 legislation, many in Congress weren’t that interested.

“It’s about money, and nobody likes to spend money,” Gillibrand said. “Congress never wants to accept the fact that treating these veterans and addressing their health care is the cost of war.”

Weeks ago, the bill appeared ready to glide through. It passed both the House and Senate but needed another vote to fix a technical legislative issue. Then on July 27, Sen. Pat Toomey (R-Pa.), who opposed the measure, unexpectedly persuaded 25 of his Republican colleagues who had supported the bill to vote against it, claiming that because the bill made the spending mandatory — not subject to the annual whims of Congress — Democrats would spend $400 billion elsewhere in the budget. Democrats countered that the money Toomey cited is already being spent and, regardless of how it’s categorized, it’s still up to Congress to appropriate it.

Rosie and veterans who had come to the Capitol that day to celebrate instead had to dig in one more time, with Stewart bringing the high-wattage attention that led the Republicans to reconsider. On Aug. 2, most Republicans decided to agree with the Democrats, and the bill passed 86 to 11.

Rosie said it never would have happened without Feal and Stewart. Stewart said it was all about Rosie, bringing together veterans in a way that Congress couldn’t ignore.

“She’s the reason I’m doing it, her and Le Roy,” Stewart said, standing outside the Capitol with Rosie the day before the vote.

Stewart, the Torreses, and untold other veterans tempered their joy with the warning that it will be a hard journey making the new program work with a VA that already has a massive backlog. The legislation has provisions to create facilities and bring in private doctors, but some vets remain dubious.

Iraq War veteran Brian Alvarado of Long Beach, California, was diagnosed with neck and throat cancer soon after returning from Iraq in 2006. He had been assigned to patrol one of the many burn pits. He eats and breathes through tubes and struggles to keep weight on. Radiation and a tracheostomy have left his voice almost inaudible.

“You can pass laws, but it all boils down to the VA. How are they going to implement the changes? The claims, the compensation, the treatment,” he asked in June. “And how long will it take?”

For the time being, though, Rosie said that even more than a visit to the White House, she was looking forward to going back to Texas and her family.

“You know, I lost 13 years away from my children, with trips to the hospital, coming to D.C.,” she said. “It means I can go home.”

Le Roy and Rosie can also reflect that as painful as this path has been, 3.5 million veterans are guaranteed a backstop because of this law, and thousands of veterans and active-duty service members who work for state and local governments now have recourse if they are fired after being injured at war.

“It is good to know that so many people will be helped,” Le Roy said from his home in Robstown, Texas. “It does help.”

KHN reporter Heidi de Marco contributed to this article.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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The battle was just beginning for Le Roy Torres and his wife, Rosie, when the Army captain returned to Texas in 2008, already starting to suffer from the toxic substances he’d inhaled from the 10-acre burn pit at Camp Anaconda in Balad, Iraq.

Along the way, Le Roy would lose the job he loved as a Texas state trooper and take his fight all the way to a Supreme Court victory. He would be rushed to the emergency room hundreds of times, be denied health benefits by the Department of Veterans Affairs for years, attempt suicide, and seek experimental cures for the damage done to his lungs and brain.

Amid all that, Le Roy and Rosie founded an organization to help others and push Congress to fix the laws that allowed the suffering of veterans to go on, and ultimately enlist people like comedian and activist Jon Stewart, who helped them win a dramatic showdown in the Senate last week.

Their struggle will never really be over. But the Torreses’ campaign to make sure no other veterans experience what they had to ends Aug. 10, when they are set to join President Joe Biden as he signs a law to guarantee that 3.5 million American warriors exposed to similar hazards can get care.

“I mean, to think that 13 years ago we were walking the halls [of Congress] — it’s really emotional,” Rosie said recently, halting to collect herself and wipe back tears, “because I think of all the people that died along the way.”

The bill provides a new entitlement program for veterans who served in a combat zone in the past 32 years. If they are diagnosed with any of 23 conditions identified in the legislation — ranging from specific cancers to breathing ailments — they would be deemed automatically eligible for health coverage. The Congressional Budget Office estimated the new benefits would cost $280 billion over the next 10 years.

Most veterans — nearly 80% — who start experiencing symptoms after leaving the service get denied what’s known as a service connection when they seek help from the VA. The system has been designed to disbelieve them, the veterans complain. They must prove their breathing problems or cancers came from the toxic trash smoke they breathed overseas, which is extremely difficult.

When Le Roy returned home from Balad Air Base — the second-largest U.S. post in Iraq and where the military incinerated tons of debris daily, including plastic, ammunition, and medical waste — he was already sick. He was rushed to the hospital a few weeks later with a severe respiratory infection.

He had expected to keep working as a state trooper, but by 2010 it was clear he couldn’t perform all the duties because of his illness. When he asked for a different job with the Texas Department of Public Safety, he was denied. He was told he had to resign if he wanted to apply for medical retirement. The retirement request was then rejected. So he sued and eventually took the case to the Supreme Court, which in June ruled that states were not immune from such lawsuits by service members.

In those early years, the military and VA doctors couldn’t say what caused his breathing problems and splitting headaches. As with other victims of toxic exposure, diagnoses proved to be difficult. Some doctors suggested the problems weren’t real — a pronouncement often encountered by other vets whose claims are denied.

Like so many others, Rosie turned to the internet for information she couldn’t get from the VA, where she had worked for 23 years. She discovered a Facebook group that she would use as the basis for a new advocacy group, Burn Pits 360.

Le Roy was ultimately diagnosed with constrictive bronchiolitis, fibrosis of the lungs, and toxic encephalopathy. He eventually got his benefits in early 2013. By then, the family was deep in debt.

For years he lived with the reality that the military he had served for 23 years refused to answer his needs, and the police force he loved didn’t seem to care.

“It’s something that we have now learned is known as moral injury and compound loss,” Rosie said.

As a man, he began to wonder how he could provide for his family, if he was any use to anyone, she added. “So then that led to him attempting to take his life.”

It also led the couple and parents of three to beseech Congress to fix the problems. They started walking the halls in the Capitol. Success there was not any easier.

“We came to Capitol Hill and just handed out information we had printed about burn pit exposure,” Le Roy said at his last visit to the Hill in June, an oxygen tube strung under his nose.

“There were a lot of doors shut in our face,” Rosie said.

 

 

While making little progress in Congress, they built Burn Pits 360 into an advocacy group and a clearinghouse to help other veterans similarly frustrated by a system that seemed to be failing them.

The breakthrough for Rosie began when she saw Stewart and 9/11 survivors’ advocate John Feal winning a similar battle to make Congress fully fund health and compensation programs for responders of the Sept. 11, 2001, terror attacks. She recalls reading up on the toxic substances in the dust and smoke that spewed from the collapsed twin towers and discovering they were remarkably similar to the poisons inhaled by troops near the waste fires that were also set ablaze with jet fuel.

She called Feal. Feal called Stewart, and by February 2019 the four of them were meeting on Capitol Hill with lawmakers, including Sen. Kirsten Gillibrand (D-N.Y.), one of the authors of the 9/11 legislation.

The key, they decided in those first meetings, was to remove the obstacles for the most common illnesses and eliminate the burden of proof on ill former soldiers. Gillibrand’s office wrote that bill, along with Rep. Raul Ruiz (D-Calif.), who championed it in the House.

Related Links

Ultimately, that bill became the heart of the measure that passed, known as the PACT Act and named for a soldier who died from cancer linked to his service.

“Our bill was the first federal presumption for burn pits coverage ever. And that was all because of Rosie and Le Roy,” said Gillibrand.

But just as with the 9/11 legislation, many in Congress weren’t that interested.

“It’s about money, and nobody likes to spend money,” Gillibrand said. “Congress never wants to accept the fact that treating these veterans and addressing their health care is the cost of war.”

Weeks ago, the bill appeared ready to glide through. It passed both the House and Senate but needed another vote to fix a technical legislative issue. Then on July 27, Sen. Pat Toomey (R-Pa.), who opposed the measure, unexpectedly persuaded 25 of his Republican colleagues who had supported the bill to vote against it, claiming that because the bill made the spending mandatory — not subject to the annual whims of Congress — Democrats would spend $400 billion elsewhere in the budget. Democrats countered that the money Toomey cited is already being spent and, regardless of how it’s categorized, it’s still up to Congress to appropriate it.

Rosie and veterans who had come to the Capitol that day to celebrate instead had to dig in one more time, with Stewart bringing the high-wattage attention that led the Republicans to reconsider. On Aug. 2, most Republicans decided to agree with the Democrats, and the bill passed 86 to 11.

Rosie said it never would have happened without Feal and Stewart. Stewart said it was all about Rosie, bringing together veterans in a way that Congress couldn’t ignore.

“She’s the reason I’m doing it, her and Le Roy,” Stewart said, standing outside the Capitol with Rosie the day before the vote.

Stewart, the Torreses, and untold other veterans tempered their joy with the warning that it will be a hard journey making the new program work with a VA that already has a massive backlog. The legislation has provisions to create facilities and bring in private doctors, but some vets remain dubious.

Iraq War veteran Brian Alvarado of Long Beach, California, was diagnosed with neck and throat cancer soon after returning from Iraq in 2006. He had been assigned to patrol one of the many burn pits. He eats and breathes through tubes and struggles to keep weight on. Radiation and a tracheostomy have left his voice almost inaudible.

“You can pass laws, but it all boils down to the VA. How are they going to implement the changes? The claims, the compensation, the treatment,” he asked in June. “And how long will it take?”

For the time being, though, Rosie said that even more than a visit to the White House, she was looking forward to going back to Texas and her family.

“You know, I lost 13 years away from my children, with trips to the hospital, coming to D.C.,” she said. “It means I can go home.”

Le Roy and Rosie can also reflect that as painful as this path has been, 3.5 million veterans are guaranteed a backstop because of this law, and thousands of veterans and active-duty service members who work for state and local governments now have recourse if they are fired after being injured at war.

“It is good to know that so many people will be helped,” Le Roy said from his home in Robstown, Texas. “It does help.”

KHN reporter Heidi de Marco contributed to this article.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

 

The battle was just beginning for Le Roy Torres and his wife, Rosie, when the Army captain returned to Texas in 2008, already starting to suffer from the toxic substances he’d inhaled from the 10-acre burn pit at Camp Anaconda in Balad, Iraq.

Along the way, Le Roy would lose the job he loved as a Texas state trooper and take his fight all the way to a Supreme Court victory. He would be rushed to the emergency room hundreds of times, be denied health benefits by the Department of Veterans Affairs for years, attempt suicide, and seek experimental cures for the damage done to his lungs and brain.

Amid all that, Le Roy and Rosie founded an organization to help others and push Congress to fix the laws that allowed the suffering of veterans to go on, and ultimately enlist people like comedian and activist Jon Stewart, who helped them win a dramatic showdown in the Senate last week.

Their struggle will never really be over. But the Torreses’ campaign to make sure no other veterans experience what they had to ends Aug. 10, when they are set to join President Joe Biden as he signs a law to guarantee that 3.5 million American warriors exposed to similar hazards can get care.

“I mean, to think that 13 years ago we were walking the halls [of Congress] — it’s really emotional,” Rosie said recently, halting to collect herself and wipe back tears, “because I think of all the people that died along the way.”

The bill provides a new entitlement program for veterans who served in a combat zone in the past 32 years. If they are diagnosed with any of 23 conditions identified in the legislation — ranging from specific cancers to breathing ailments — they would be deemed automatically eligible for health coverage. The Congressional Budget Office estimated the new benefits would cost $280 billion over the next 10 years.

Most veterans — nearly 80% — who start experiencing symptoms after leaving the service get denied what’s known as a service connection when they seek help from the VA. The system has been designed to disbelieve them, the veterans complain. They must prove their breathing problems or cancers came from the toxic trash smoke they breathed overseas, which is extremely difficult.

When Le Roy returned home from Balad Air Base — the second-largest U.S. post in Iraq and where the military incinerated tons of debris daily, including plastic, ammunition, and medical waste — he was already sick. He was rushed to the hospital a few weeks later with a severe respiratory infection.

He had expected to keep working as a state trooper, but by 2010 it was clear he couldn’t perform all the duties because of his illness. When he asked for a different job with the Texas Department of Public Safety, he was denied. He was told he had to resign if he wanted to apply for medical retirement. The retirement request was then rejected. So he sued and eventually took the case to the Supreme Court, which in June ruled that states were not immune from such lawsuits by service members.

In those early years, the military and VA doctors couldn’t say what caused his breathing problems and splitting headaches. As with other victims of toxic exposure, diagnoses proved to be difficult. Some doctors suggested the problems weren’t real — a pronouncement often encountered by other vets whose claims are denied.

Like so many others, Rosie turned to the internet for information she couldn’t get from the VA, where she had worked for 23 years. She discovered a Facebook group that she would use as the basis for a new advocacy group, Burn Pits 360.

Le Roy was ultimately diagnosed with constrictive bronchiolitis, fibrosis of the lungs, and toxic encephalopathy. He eventually got his benefits in early 2013. By then, the family was deep in debt.

For years he lived with the reality that the military he had served for 23 years refused to answer his needs, and the police force he loved didn’t seem to care.

“It’s something that we have now learned is known as moral injury and compound loss,” Rosie said.

As a man, he began to wonder how he could provide for his family, if he was any use to anyone, she added. “So then that led to him attempting to take his life.”

It also led the couple and parents of three to beseech Congress to fix the problems. They started walking the halls in the Capitol. Success there was not any easier.

“We came to Capitol Hill and just handed out information we had printed about burn pit exposure,” Le Roy said at his last visit to the Hill in June, an oxygen tube strung under his nose.

“There were a lot of doors shut in our face,” Rosie said.

 

 

While making little progress in Congress, they built Burn Pits 360 into an advocacy group and a clearinghouse to help other veterans similarly frustrated by a system that seemed to be failing them.

The breakthrough for Rosie began when she saw Stewart and 9/11 survivors’ advocate John Feal winning a similar battle to make Congress fully fund health and compensation programs for responders of the Sept. 11, 2001, terror attacks. She recalls reading up on the toxic substances in the dust and smoke that spewed from the collapsed twin towers and discovering they were remarkably similar to the poisons inhaled by troops near the waste fires that were also set ablaze with jet fuel.

She called Feal. Feal called Stewart, and by February 2019 the four of them were meeting on Capitol Hill with lawmakers, including Sen. Kirsten Gillibrand (D-N.Y.), one of the authors of the 9/11 legislation.

The key, they decided in those first meetings, was to remove the obstacles for the most common illnesses and eliminate the burden of proof on ill former soldiers. Gillibrand’s office wrote that bill, along with Rep. Raul Ruiz (D-Calif.), who championed it in the House.

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Ultimately, that bill became the heart of the measure that passed, known as the PACT Act and named for a soldier who died from cancer linked to his service.

“Our bill was the first federal presumption for burn pits coverage ever. And that was all because of Rosie and Le Roy,” said Gillibrand.

But just as with the 9/11 legislation, many in Congress weren’t that interested.

“It’s about money, and nobody likes to spend money,” Gillibrand said. “Congress never wants to accept the fact that treating these veterans and addressing their health care is the cost of war.”

Weeks ago, the bill appeared ready to glide through. It passed both the House and Senate but needed another vote to fix a technical legislative issue. Then on July 27, Sen. Pat Toomey (R-Pa.), who opposed the measure, unexpectedly persuaded 25 of his Republican colleagues who had supported the bill to vote against it, claiming that because the bill made the spending mandatory — not subject to the annual whims of Congress — Democrats would spend $400 billion elsewhere in the budget. Democrats countered that the money Toomey cited is already being spent and, regardless of how it’s categorized, it’s still up to Congress to appropriate it.

Rosie and veterans who had come to the Capitol that day to celebrate instead had to dig in one more time, with Stewart bringing the high-wattage attention that led the Republicans to reconsider. On Aug. 2, most Republicans decided to agree with the Democrats, and the bill passed 86 to 11.

Rosie said it never would have happened without Feal and Stewart. Stewart said it was all about Rosie, bringing together veterans in a way that Congress couldn’t ignore.

“She’s the reason I’m doing it, her and Le Roy,” Stewart said, standing outside the Capitol with Rosie the day before the vote.

Stewart, the Torreses, and untold other veterans tempered their joy with the warning that it will be a hard journey making the new program work with a VA that already has a massive backlog. The legislation has provisions to create facilities and bring in private doctors, but some vets remain dubious.

Iraq War veteran Brian Alvarado of Long Beach, California, was diagnosed with neck and throat cancer soon after returning from Iraq in 2006. He had been assigned to patrol one of the many burn pits. He eats and breathes through tubes and struggles to keep weight on. Radiation and a tracheostomy have left his voice almost inaudible.

“You can pass laws, but it all boils down to the VA. How are they going to implement the changes? The claims, the compensation, the treatment,” he asked in June. “And how long will it take?”

For the time being, though, Rosie said that even more than a visit to the White House, she was looking forward to going back to Texas and her family.

“You know, I lost 13 years away from my children, with trips to the hospital, coming to D.C.,” she said. “It means I can go home.”

Le Roy and Rosie can also reflect that as painful as this path has been, 3.5 million veterans are guaranteed a backstop because of this law, and thousands of veterans and active-duty service members who work for state and local governments now have recourse if they are fired after being injured at war.

“It is good to know that so many people will be helped,” Le Roy said from his home in Robstown, Texas. “It does help.”

KHN reporter Heidi de Marco contributed to this article.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Cardiorespiratory fitness key to longevity for all?

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Tue, 08/16/2022 - 09:18

Cardiorespiratory fitness emerged as a stronger predictor of all-cause mortality than did any traditional risk factor across the spectrum of age, sex, and race in a modeling study that included more than 750,000 U.S. veterans.

In addition, mortality risk was cut in half if individuals achieved a moderate cardiorespiratory fitness (CRF) level – that is, by meeting the current U.S. physical activity recommendations of 150 minutes per week, the authors note.

Furthermore, contrary to some previous research, “extremely high” fitness was not associated with an increased risk for mortality in the study, published online in the Journal of the American College of Cardiology.

“This study has been 15 years in the making,” lead author Peter Kokkinos, PhD, Rutgers University, New Brunswick, N.J., and the VA Medical Center, Washington, told this news organization. “We waited until we had the computer power and the right people to really assess this. We wanted to be very liberal in excluding patients we thought might contaminate the results, such as those with cardiovascular disease in the 6 months prior to a stress test.”

Figuring the time was right, the team analyzed data from the VA’s Exercise Testing and Health Outcomes Study (ETHOS) on individuals aged 30-95 years who underwent exercise treadmill tests between 1999 and 2020.

After exclusions, 750,302 individuals (from among 822,995) were included: 6.5% were women; 73.7% were White individuals; 19% were African American individuals; 4.7% were Hispanic individuals; and 2.1% were Native American, Asian, or Hawaiian individuals. Septuagenarians made up 14.7% of the cohort, and octogenarians made up 3.6%.

CRF categories for age and sex were determined by the peak metabolic equivalent of task (MET) achieved during the treadmill test. One MET is the energy spent at rest – that is the basal metabolic rate.

Although some physicians may resist putting patients through a stress test, “the amount of information we get from it is incredible,” Dr. Kokkinos noted. “We get blood pressure, we get heart rate, we get a response if you’re not doing exercise. This tells us a lot more than having you sit around so we can measure resting heart rate and blood pressure.”

Lowest mortality at 14.0 METs

During a median follow-up of 10.2 years (7,803,861 person-years), 23% of participants died, for an average of 22.4 events per 1,000 person-years.

Higher exercise capacity was inversely related to mortality risk across the cohort and within each age category. Specifically, every 1 MET increase in exercise capacity yielded an adjusted hazard ratio for mortality of 0.86 (95% confidence interval, 0.85-0.87; P < .001) for the entire cohort and similar HRs by sex and race.

The mortality risk for the least-fit individuals (20th percentile) was fourfold higher than for extremely fit individuals (HR, 4.09; 95% CI, 3.90-4.20), with the lowest mortality risk at about 14.0 METs for both men (HR, 0.24; 95% CI, 0.23-0.25) and women (HR, 0.23; 95% CI, 0.17-0.29). Extremely high CRF did not increase the risk.

In addition, at 20 years of follow-up, about 80% of men and 95% of women in the highest CRF category (98th percentile) were alive vs. less than 40% of men and approximately 75% of women in the least fit CRF category.

“We know CRF declines by 1% per year after age 30,” Dr. Kokkinos said. “But the age-related decline is cut in half if you are fit, meaning that an expected 10% decline over a decade will be only a 5% decline if you stay active. We cannot stop or reverse the decline, but we can kind of put the brakes on, and that’s a reason for clinicians to continue to encourage fitness.” 

Indeed, “improving CRF should be considered a target in CVD prevention, similar to improving lipids, blood sugar, blood pressure, and weight,” Carl J. Lavie, MD, Ochsner Health, New Orleans, and colleagues affirm in a related editorial.
 

 

 

‘A difficult battle’

But that may not happen any time soon. “Unfortunately, despite having been recognized in an American Heart Association scientific statement as a clinical vital sign, aerobic fitness is undervalued and underutilized,” Claudio Gil Araújo, MD, PhD, research director of the Exercise Medicine Clinic-CLINIMEX, Rio de Janeiro, told this news organization.

Dr. Araújo led a recent study showing that the ability to stand on one leg for at least 10 seconds is strongly linked to the risk for death over the next 7 years.

Although physicians should be encouraging fitness, he said that “a substantial part of health professionals are physically unfit and feel uncomfortable talking about and prescribing exercise for their patients. Also, physicians tend to be better trained in treating diseases (using medications and/or prescribing procedures) than in preventing diseases by stimulating adoption of healthy habits. So, this a long road and a difficult battle.”

Nonetheless, he added, “Darwin said a long time ago that only the fittest will survive. If Darwin could read this study, he would surely smile.”

No commercial funding or conflicts of interest related to the study were reported. Dr. Lavie previously served as a speaker and consultant for PAI Health on their PAI (Personalized Activity Intelligence) applications.

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

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Cardiorespiratory fitness emerged as a stronger predictor of all-cause mortality than did any traditional risk factor across the spectrum of age, sex, and race in a modeling study that included more than 750,000 U.S. veterans.

In addition, mortality risk was cut in half if individuals achieved a moderate cardiorespiratory fitness (CRF) level – that is, by meeting the current U.S. physical activity recommendations of 150 minutes per week, the authors note.

Furthermore, contrary to some previous research, “extremely high” fitness was not associated with an increased risk for mortality in the study, published online in the Journal of the American College of Cardiology.

“This study has been 15 years in the making,” lead author Peter Kokkinos, PhD, Rutgers University, New Brunswick, N.J., and the VA Medical Center, Washington, told this news organization. “We waited until we had the computer power and the right people to really assess this. We wanted to be very liberal in excluding patients we thought might contaminate the results, such as those with cardiovascular disease in the 6 months prior to a stress test.”

Figuring the time was right, the team analyzed data from the VA’s Exercise Testing and Health Outcomes Study (ETHOS) on individuals aged 30-95 years who underwent exercise treadmill tests between 1999 and 2020.

After exclusions, 750,302 individuals (from among 822,995) were included: 6.5% were women; 73.7% were White individuals; 19% were African American individuals; 4.7% were Hispanic individuals; and 2.1% were Native American, Asian, or Hawaiian individuals. Septuagenarians made up 14.7% of the cohort, and octogenarians made up 3.6%.

CRF categories for age and sex were determined by the peak metabolic equivalent of task (MET) achieved during the treadmill test. One MET is the energy spent at rest – that is the basal metabolic rate.

Although some physicians may resist putting patients through a stress test, “the amount of information we get from it is incredible,” Dr. Kokkinos noted. “We get blood pressure, we get heart rate, we get a response if you’re not doing exercise. This tells us a lot more than having you sit around so we can measure resting heart rate and blood pressure.”

Lowest mortality at 14.0 METs

During a median follow-up of 10.2 years (7,803,861 person-years), 23% of participants died, for an average of 22.4 events per 1,000 person-years.

Higher exercise capacity was inversely related to mortality risk across the cohort and within each age category. Specifically, every 1 MET increase in exercise capacity yielded an adjusted hazard ratio for mortality of 0.86 (95% confidence interval, 0.85-0.87; P < .001) for the entire cohort and similar HRs by sex and race.

The mortality risk for the least-fit individuals (20th percentile) was fourfold higher than for extremely fit individuals (HR, 4.09; 95% CI, 3.90-4.20), with the lowest mortality risk at about 14.0 METs for both men (HR, 0.24; 95% CI, 0.23-0.25) and women (HR, 0.23; 95% CI, 0.17-0.29). Extremely high CRF did not increase the risk.

In addition, at 20 years of follow-up, about 80% of men and 95% of women in the highest CRF category (98th percentile) were alive vs. less than 40% of men and approximately 75% of women in the least fit CRF category.

“We know CRF declines by 1% per year after age 30,” Dr. Kokkinos said. “But the age-related decline is cut in half if you are fit, meaning that an expected 10% decline over a decade will be only a 5% decline if you stay active. We cannot stop or reverse the decline, but we can kind of put the brakes on, and that’s a reason for clinicians to continue to encourage fitness.” 

Indeed, “improving CRF should be considered a target in CVD prevention, similar to improving lipids, blood sugar, blood pressure, and weight,” Carl J. Lavie, MD, Ochsner Health, New Orleans, and colleagues affirm in a related editorial.
 

 

 

‘A difficult battle’

But that may not happen any time soon. “Unfortunately, despite having been recognized in an American Heart Association scientific statement as a clinical vital sign, aerobic fitness is undervalued and underutilized,” Claudio Gil Araújo, MD, PhD, research director of the Exercise Medicine Clinic-CLINIMEX, Rio de Janeiro, told this news organization.

Dr. Araújo led a recent study showing that the ability to stand on one leg for at least 10 seconds is strongly linked to the risk for death over the next 7 years.

Although physicians should be encouraging fitness, he said that “a substantial part of health professionals are physically unfit and feel uncomfortable talking about and prescribing exercise for their patients. Also, physicians tend to be better trained in treating diseases (using medications and/or prescribing procedures) than in preventing diseases by stimulating adoption of healthy habits. So, this a long road and a difficult battle.”

Nonetheless, he added, “Darwin said a long time ago that only the fittest will survive. If Darwin could read this study, he would surely smile.”

No commercial funding or conflicts of interest related to the study were reported. Dr. Lavie previously served as a speaker and consultant for PAI Health on their PAI (Personalized Activity Intelligence) applications.

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

Cardiorespiratory fitness emerged as a stronger predictor of all-cause mortality than did any traditional risk factor across the spectrum of age, sex, and race in a modeling study that included more than 750,000 U.S. veterans.

In addition, mortality risk was cut in half if individuals achieved a moderate cardiorespiratory fitness (CRF) level – that is, by meeting the current U.S. physical activity recommendations of 150 minutes per week, the authors note.

Furthermore, contrary to some previous research, “extremely high” fitness was not associated with an increased risk for mortality in the study, published online in the Journal of the American College of Cardiology.

“This study has been 15 years in the making,” lead author Peter Kokkinos, PhD, Rutgers University, New Brunswick, N.J., and the VA Medical Center, Washington, told this news organization. “We waited until we had the computer power and the right people to really assess this. We wanted to be very liberal in excluding patients we thought might contaminate the results, such as those with cardiovascular disease in the 6 months prior to a stress test.”

Figuring the time was right, the team analyzed data from the VA’s Exercise Testing and Health Outcomes Study (ETHOS) on individuals aged 30-95 years who underwent exercise treadmill tests between 1999 and 2020.

After exclusions, 750,302 individuals (from among 822,995) were included: 6.5% were women; 73.7% were White individuals; 19% were African American individuals; 4.7% were Hispanic individuals; and 2.1% were Native American, Asian, or Hawaiian individuals. Septuagenarians made up 14.7% of the cohort, and octogenarians made up 3.6%.

CRF categories for age and sex were determined by the peak metabolic equivalent of task (MET) achieved during the treadmill test. One MET is the energy spent at rest – that is the basal metabolic rate.

Although some physicians may resist putting patients through a stress test, “the amount of information we get from it is incredible,” Dr. Kokkinos noted. “We get blood pressure, we get heart rate, we get a response if you’re not doing exercise. This tells us a lot more than having you sit around so we can measure resting heart rate and blood pressure.”

Lowest mortality at 14.0 METs

During a median follow-up of 10.2 years (7,803,861 person-years), 23% of participants died, for an average of 22.4 events per 1,000 person-years.

Higher exercise capacity was inversely related to mortality risk across the cohort and within each age category. Specifically, every 1 MET increase in exercise capacity yielded an adjusted hazard ratio for mortality of 0.86 (95% confidence interval, 0.85-0.87; P < .001) for the entire cohort and similar HRs by sex and race.

The mortality risk for the least-fit individuals (20th percentile) was fourfold higher than for extremely fit individuals (HR, 4.09; 95% CI, 3.90-4.20), with the lowest mortality risk at about 14.0 METs for both men (HR, 0.24; 95% CI, 0.23-0.25) and women (HR, 0.23; 95% CI, 0.17-0.29). Extremely high CRF did not increase the risk.

In addition, at 20 years of follow-up, about 80% of men and 95% of women in the highest CRF category (98th percentile) were alive vs. less than 40% of men and approximately 75% of women in the least fit CRF category.

“We know CRF declines by 1% per year after age 30,” Dr. Kokkinos said. “But the age-related decline is cut in half if you are fit, meaning that an expected 10% decline over a decade will be only a 5% decline if you stay active. We cannot stop or reverse the decline, but we can kind of put the brakes on, and that’s a reason for clinicians to continue to encourage fitness.” 

Indeed, “improving CRF should be considered a target in CVD prevention, similar to improving lipids, blood sugar, blood pressure, and weight,” Carl J. Lavie, MD, Ochsner Health, New Orleans, and colleagues affirm in a related editorial.
 

 

 

‘A difficult battle’

But that may not happen any time soon. “Unfortunately, despite having been recognized in an American Heart Association scientific statement as a clinical vital sign, aerobic fitness is undervalued and underutilized,” Claudio Gil Araújo, MD, PhD, research director of the Exercise Medicine Clinic-CLINIMEX, Rio de Janeiro, told this news organization.

Dr. Araújo led a recent study showing that the ability to stand on one leg for at least 10 seconds is strongly linked to the risk for death over the next 7 years.

Although physicians should be encouraging fitness, he said that “a substantial part of health professionals are physically unfit and feel uncomfortable talking about and prescribing exercise for their patients. Also, physicians tend to be better trained in treating diseases (using medications and/or prescribing procedures) than in preventing diseases by stimulating adoption of healthy habits. So, this a long road and a difficult battle.”

Nonetheless, he added, “Darwin said a long time ago that only the fittest will survive. If Darwin could read this study, he would surely smile.”

No commercial funding or conflicts of interest related to the study were reported. Dr. Lavie previously served as a speaker and consultant for PAI Health on their PAI (Personalized Activity Intelligence) applications.

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

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FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

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Tobramycin tames infection in bronchiectasis

Article Type
Changed
Wed, 08/10/2022 - 10:36

Nebulized tobramycin significantly reduced the density of Pseudomonas aeruginosa in sputum and improved quality of life for adults with bronchiectasis in a study with more than 300 individuals.

Chronic P. aeruginosa infection remains a challenge for bronchiectasis patients, and treatment options are limited, wrote Wei-jie Guan, MD, of the First Affiliated Hospital of Guangzhou Medical University, Guangdong, China, and colleagues. Tobramycin has demonstrated antipseudomonal effects, but previous studies have been small, results have been inconclusive, and there are safety concerns with the currently approved method of intravenous injection.

In a study published in the journal Chest, the researchers randomly assigned 167 patients to receive nebulized tobramycin inhalation solution (TIS) and 172 patients to receive placebo. Patients in the active-treatment group received 300 mg/5 mL of TIS twice daily in two cycles of 28 days on- and off-treatment alternating periods. The primary endpoints were changes in P. aeruginosa density from baseline and scores on the Quality of Life–Bronchiectasis questionnaire at day 29. Follow-up data were collected every 4 weeks for 16 weeks. Secondary endpoints included rate of negative P. aeruginosa culture at day 29; change in P. aeruginosa density from baseline; quality of life at day 85; and 24-hour sputum volume and purulence at day 29, 57, and 85.

The study population included adults aged 18-75 years with symptomatic bronchiectasis. The participants’ conditions had been clinically stable for 4 weeks. Sputum cultures tested positive for P. aeruginosa at two consecutive screening visits prior to randomization. The study was conducted at 33 sites within mainland China.

Overall, among the patients in the TIS group, there was a significantly greater reduction in P. aeruginosa density, compared with placebo patients, with an adjusted mean difference of 1.74 Log10 colony-forming units/g (P < .001). TIS patients also showed significantly greater improvement in Quality of Life–Bronchiectasis respiratory symptom scores, with an adjusted mean difference of 7.91 (P < .001) at day 29.

In addition, more TIS patients became culture negative for P. aeruginosa by day 29, compared with placebo patients (29.3% vs. 10.6%), and 24-hour sputum volume and sputum purulence scores were significantly lower for TIS patients at day 29, day 57, and day 85, compared with placebo patients.

Adverse events were similar and occurred in 81.5% of TIS patients and 81.6% of placebo patients. The most common were hemoptysis, chest discomfort, and acute upper respiratory tract infections. A total of 10 patients in the TIS group experienced transient wheezing that resolved within 30 minutes. A total of 11 TIS patients and 5 placebo patients experienced an adverse event that caused them to discontinue participation in the study. These events included blurred vision and dizziness, which occurred in two TIS patients and was deemed related to the study drug. One TIS patient died as a result of acute myocardial infarction, but this was deemed to be unrelated to the study drug.

The findings were limited by several factors, including the short duration of treatment and relatively young population, which might affect generalizability, the researchers noted. Other limitations include a lack of data on the effects of TIS on microorganisms other than P. aeruginosa, as well as limited outpatient visits, owing to COVID-19 restrictions.

However, the results confirm the ability of TIS nebulization to reduce P. aeruginosa and improve quality of life for adult patients with bronchiectasis, the authors concluded.

The study was funded by grants to multiple researchers from the National Science and Technology Major Project of the Ministry of Science and Technology of China and other government sources. The researchers disclosed no relevant financial relationships.

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

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Nebulized tobramycin significantly reduced the density of Pseudomonas aeruginosa in sputum and improved quality of life for adults with bronchiectasis in a study with more than 300 individuals.

Chronic P. aeruginosa infection remains a challenge for bronchiectasis patients, and treatment options are limited, wrote Wei-jie Guan, MD, of the First Affiliated Hospital of Guangzhou Medical University, Guangdong, China, and colleagues. Tobramycin has demonstrated antipseudomonal effects, but previous studies have been small, results have been inconclusive, and there are safety concerns with the currently approved method of intravenous injection.

In a study published in the journal Chest, the researchers randomly assigned 167 patients to receive nebulized tobramycin inhalation solution (TIS) and 172 patients to receive placebo. Patients in the active-treatment group received 300 mg/5 mL of TIS twice daily in two cycles of 28 days on- and off-treatment alternating periods. The primary endpoints were changes in P. aeruginosa density from baseline and scores on the Quality of Life–Bronchiectasis questionnaire at day 29. Follow-up data were collected every 4 weeks for 16 weeks. Secondary endpoints included rate of negative P. aeruginosa culture at day 29; change in P. aeruginosa density from baseline; quality of life at day 85; and 24-hour sputum volume and purulence at day 29, 57, and 85.

The study population included adults aged 18-75 years with symptomatic bronchiectasis. The participants’ conditions had been clinically stable for 4 weeks. Sputum cultures tested positive for P. aeruginosa at two consecutive screening visits prior to randomization. The study was conducted at 33 sites within mainland China.

Overall, among the patients in the TIS group, there was a significantly greater reduction in P. aeruginosa density, compared with placebo patients, with an adjusted mean difference of 1.74 Log10 colony-forming units/g (P < .001). TIS patients also showed significantly greater improvement in Quality of Life–Bronchiectasis respiratory symptom scores, with an adjusted mean difference of 7.91 (P < .001) at day 29.

In addition, more TIS patients became culture negative for P. aeruginosa by day 29, compared with placebo patients (29.3% vs. 10.6%), and 24-hour sputum volume and sputum purulence scores were significantly lower for TIS patients at day 29, day 57, and day 85, compared with placebo patients.

Adverse events were similar and occurred in 81.5% of TIS patients and 81.6% of placebo patients. The most common were hemoptysis, chest discomfort, and acute upper respiratory tract infections. A total of 10 patients in the TIS group experienced transient wheezing that resolved within 30 minutes. A total of 11 TIS patients and 5 placebo patients experienced an adverse event that caused them to discontinue participation in the study. These events included blurred vision and dizziness, which occurred in two TIS patients and was deemed related to the study drug. One TIS patient died as a result of acute myocardial infarction, but this was deemed to be unrelated to the study drug.

The findings were limited by several factors, including the short duration of treatment and relatively young population, which might affect generalizability, the researchers noted. Other limitations include a lack of data on the effects of TIS on microorganisms other than P. aeruginosa, as well as limited outpatient visits, owing to COVID-19 restrictions.

However, the results confirm the ability of TIS nebulization to reduce P. aeruginosa and improve quality of life for adult patients with bronchiectasis, the authors concluded.

The study was funded by grants to multiple researchers from the National Science and Technology Major Project of the Ministry of Science and Technology of China and other government sources. The researchers disclosed no relevant financial relationships.

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

Nebulized tobramycin significantly reduced the density of Pseudomonas aeruginosa in sputum and improved quality of life for adults with bronchiectasis in a study with more than 300 individuals.

Chronic P. aeruginosa infection remains a challenge for bronchiectasis patients, and treatment options are limited, wrote Wei-jie Guan, MD, of the First Affiliated Hospital of Guangzhou Medical University, Guangdong, China, and colleagues. Tobramycin has demonstrated antipseudomonal effects, but previous studies have been small, results have been inconclusive, and there are safety concerns with the currently approved method of intravenous injection.

In a study published in the journal Chest, the researchers randomly assigned 167 patients to receive nebulized tobramycin inhalation solution (TIS) and 172 patients to receive placebo. Patients in the active-treatment group received 300 mg/5 mL of TIS twice daily in two cycles of 28 days on- and off-treatment alternating periods. The primary endpoints were changes in P. aeruginosa density from baseline and scores on the Quality of Life–Bronchiectasis questionnaire at day 29. Follow-up data were collected every 4 weeks for 16 weeks. Secondary endpoints included rate of negative P. aeruginosa culture at day 29; change in P. aeruginosa density from baseline; quality of life at day 85; and 24-hour sputum volume and purulence at day 29, 57, and 85.

The study population included adults aged 18-75 years with symptomatic bronchiectasis. The participants’ conditions had been clinically stable for 4 weeks. Sputum cultures tested positive for P. aeruginosa at two consecutive screening visits prior to randomization. The study was conducted at 33 sites within mainland China.

Overall, among the patients in the TIS group, there was a significantly greater reduction in P. aeruginosa density, compared with placebo patients, with an adjusted mean difference of 1.74 Log10 colony-forming units/g (P < .001). TIS patients also showed significantly greater improvement in Quality of Life–Bronchiectasis respiratory symptom scores, with an adjusted mean difference of 7.91 (P < .001) at day 29.

In addition, more TIS patients became culture negative for P. aeruginosa by day 29, compared with placebo patients (29.3% vs. 10.6%), and 24-hour sputum volume and sputum purulence scores were significantly lower for TIS patients at day 29, day 57, and day 85, compared with placebo patients.

Adverse events were similar and occurred in 81.5% of TIS patients and 81.6% of placebo patients. The most common were hemoptysis, chest discomfort, and acute upper respiratory tract infections. A total of 10 patients in the TIS group experienced transient wheezing that resolved within 30 minutes. A total of 11 TIS patients and 5 placebo patients experienced an adverse event that caused them to discontinue participation in the study. These events included blurred vision and dizziness, which occurred in two TIS patients and was deemed related to the study drug. One TIS patient died as a result of acute myocardial infarction, but this was deemed to be unrelated to the study drug.

The findings were limited by several factors, including the short duration of treatment and relatively young population, which might affect generalizability, the researchers noted. Other limitations include a lack of data on the effects of TIS on microorganisms other than P. aeruginosa, as well as limited outpatient visits, owing to COVID-19 restrictions.

However, the results confirm the ability of TIS nebulization to reduce P. aeruginosa and improve quality of life for adult patients with bronchiectasis, the authors concluded.

The study was funded by grants to multiple researchers from the National Science and Technology Major Project of the Ministry of Science and Technology of China and other government sources. The researchers disclosed no relevant financial relationships.

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

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