Osteoporosis and osteopenia: Latest treatment recommendations

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Fri, 04/28/2023 - 00:30

 



This transcript has been edited for clarity.

I’m Dr. Neil Skolnik. Today’s topic is the new osteoporosis treatment guidelines issued by the American College of Physicians (ACP). The focus of the guidelines is treatment of osteoporosis. But first, I want to discuss screening.

In its 2018 statement, the U.S. Preventive Services Task Force (USPSTF) says that osteoporosis should be screened for in women older than 65 years of age, and those who are younger who are at increased risk based on a risk assessment tool (usually the FRAX tool). There is not enough evidence to weigh in for or against screening men. The other large organization that weighs in on screening is the Bone Health & Osteoporosis Foundation, which agrees with the USPSTF, but in addition says that we should be screening men over age 70 and men who are younger (age 50 to 69) who have risk factors. We should also screen anyone who has a fracture after low impact or no trauma.

Let’s now go on to the ACP treatment guidelines. Osteoporosis is defined as bone mineral density at the femoral neck or the lumbar spine, or both, with a T score less than -2.5.

For postmenopausal women with osteoporosis, you should use a bisphosphonate as first-line treatment to reduce the risk for future fractures. This is given a strong recommendation based on a high certainty of evidence. Bisphosphonates vs. placebo over 3 years leads to one fewer hip fracture per 150 patients treated and one fewer vertebral fracture per 50 people treated.

All the other recommendations in the guidelines are considered “conditional recommendations” that are correct for most people. But whether they make sense for an individual patient depends upon other details, as well as their values and preferences. For instance, treatment of osteoporosis in men is given a conditional recommendation, not because the evidence suggests that it’s not as effective, but because there is not as much evidence. Initial treatment for a man with osteoporosis is with bisphosphonates. Men do get osteoporosis and account for about 30% of hip fractures. This is not a surprise to anyone who takes care of older adults.

For postmenopausal women or men who you would want to treat but who can’t tolerate a bisphosphonate, then the recommendation is to use a RANK ligand inhibitor. Denosumab can be used as second-line treatment to reduce the risk for fractures. Remember, bisphosphonates and denosumab are antiresorptive drugs, meaning they slow the progression of osteoporosis. The anabolic drugs, on the other hand, such as the sclerostin inhibitor romosozumab and recombinant human parathyroid hormone (PTH) teriparatide, increase bone density. The anabolic agents should be used only in women with primary osteoporosis who are at very high risk for fractures, and use of these agents always needs to be followed by an antiresorptive agent, because otherwise there’s a risk for rebound osteoporosis and an increased risk for vertebral fractures.

Now, how about osteopenia? The guidelines recommend that for women over 65 with osteopenia, use an individualized approach influenced by the level of risk for fracture, including increased age, low body weight, current smoking, hip fracture in a parent, fall risk, and a personal history of fracture. The guidelines note that increasing the duration of bisphosphonate therapy beyond 3-5 years does reduce the risk for new vertebral fractures, but it doesn’t reduce the risk for other fractures and it increases the risk for osteonecrosis of the jaw and atypical hip fractures. Therefore, the guidelines say that we should use bisphosphonates only for 3-5 years unless someone is at extremely high risk. It’s also important to note that there’s a fivefold higher risk for atypical femoral fractures among Asian women.

Don’t forget about adequate vitamin D and calcium. And most importantly, don’t forget about exercise, particularly exercise aimed at improving balance and quadriceps strength, which helps prevent falls.
 

Dr. Skolnik is professor, department of family medicine, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director, department of family medicine, Abington (Pa.) Jefferson Health. He disclosed ties with AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Sanofi, Sanofi Pasteur, and Teva.

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

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This transcript has been edited for clarity.

I’m Dr. Neil Skolnik. Today’s topic is the new osteoporosis treatment guidelines issued by the American College of Physicians (ACP). The focus of the guidelines is treatment of osteoporosis. But first, I want to discuss screening.

In its 2018 statement, the U.S. Preventive Services Task Force (USPSTF) says that osteoporosis should be screened for in women older than 65 years of age, and those who are younger who are at increased risk based on a risk assessment tool (usually the FRAX tool). There is not enough evidence to weigh in for or against screening men. The other large organization that weighs in on screening is the Bone Health & Osteoporosis Foundation, which agrees with the USPSTF, but in addition says that we should be screening men over age 70 and men who are younger (age 50 to 69) who have risk factors. We should also screen anyone who has a fracture after low impact or no trauma.

Let’s now go on to the ACP treatment guidelines. Osteoporosis is defined as bone mineral density at the femoral neck or the lumbar spine, or both, with a T score less than -2.5.

For postmenopausal women with osteoporosis, you should use a bisphosphonate as first-line treatment to reduce the risk for future fractures. This is given a strong recommendation based on a high certainty of evidence. Bisphosphonates vs. placebo over 3 years leads to one fewer hip fracture per 150 patients treated and one fewer vertebral fracture per 50 people treated.

All the other recommendations in the guidelines are considered “conditional recommendations” that are correct for most people. But whether they make sense for an individual patient depends upon other details, as well as their values and preferences. For instance, treatment of osteoporosis in men is given a conditional recommendation, not because the evidence suggests that it’s not as effective, but because there is not as much evidence. Initial treatment for a man with osteoporosis is with bisphosphonates. Men do get osteoporosis and account for about 30% of hip fractures. This is not a surprise to anyone who takes care of older adults.

For postmenopausal women or men who you would want to treat but who can’t tolerate a bisphosphonate, then the recommendation is to use a RANK ligand inhibitor. Denosumab can be used as second-line treatment to reduce the risk for fractures. Remember, bisphosphonates and denosumab are antiresorptive drugs, meaning they slow the progression of osteoporosis. The anabolic drugs, on the other hand, such as the sclerostin inhibitor romosozumab and recombinant human parathyroid hormone (PTH) teriparatide, increase bone density. The anabolic agents should be used only in women with primary osteoporosis who are at very high risk for fractures, and use of these agents always needs to be followed by an antiresorptive agent, because otherwise there’s a risk for rebound osteoporosis and an increased risk for vertebral fractures.

Now, how about osteopenia? The guidelines recommend that for women over 65 with osteopenia, use an individualized approach influenced by the level of risk for fracture, including increased age, low body weight, current smoking, hip fracture in a parent, fall risk, and a personal history of fracture. The guidelines note that increasing the duration of bisphosphonate therapy beyond 3-5 years does reduce the risk for new vertebral fractures, but it doesn’t reduce the risk for other fractures and it increases the risk for osteonecrosis of the jaw and atypical hip fractures. Therefore, the guidelines say that we should use bisphosphonates only for 3-5 years unless someone is at extremely high risk. It’s also important to note that there’s a fivefold higher risk for atypical femoral fractures among Asian women.

Don’t forget about adequate vitamin D and calcium. And most importantly, don’t forget about exercise, particularly exercise aimed at improving balance and quadriceps strength, which helps prevent falls.
 

Dr. Skolnik is professor, department of family medicine, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director, department of family medicine, Abington (Pa.) Jefferson Health. He disclosed ties with AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Sanofi, Sanofi Pasteur, and Teva.

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

 



This transcript has been edited for clarity.

I’m Dr. Neil Skolnik. Today’s topic is the new osteoporosis treatment guidelines issued by the American College of Physicians (ACP). The focus of the guidelines is treatment of osteoporosis. But first, I want to discuss screening.

In its 2018 statement, the U.S. Preventive Services Task Force (USPSTF) says that osteoporosis should be screened for in women older than 65 years of age, and those who are younger who are at increased risk based on a risk assessment tool (usually the FRAX tool). There is not enough evidence to weigh in for or against screening men. The other large organization that weighs in on screening is the Bone Health & Osteoporosis Foundation, which agrees with the USPSTF, but in addition says that we should be screening men over age 70 and men who are younger (age 50 to 69) who have risk factors. We should also screen anyone who has a fracture after low impact or no trauma.

Let’s now go on to the ACP treatment guidelines. Osteoporosis is defined as bone mineral density at the femoral neck or the lumbar spine, or both, with a T score less than -2.5.

For postmenopausal women with osteoporosis, you should use a bisphosphonate as first-line treatment to reduce the risk for future fractures. This is given a strong recommendation based on a high certainty of evidence. Bisphosphonates vs. placebo over 3 years leads to one fewer hip fracture per 150 patients treated and one fewer vertebral fracture per 50 people treated.

All the other recommendations in the guidelines are considered “conditional recommendations” that are correct for most people. But whether they make sense for an individual patient depends upon other details, as well as their values and preferences. For instance, treatment of osteoporosis in men is given a conditional recommendation, not because the evidence suggests that it’s not as effective, but because there is not as much evidence. Initial treatment for a man with osteoporosis is with bisphosphonates. Men do get osteoporosis and account for about 30% of hip fractures. This is not a surprise to anyone who takes care of older adults.

For postmenopausal women or men who you would want to treat but who can’t tolerate a bisphosphonate, then the recommendation is to use a RANK ligand inhibitor. Denosumab can be used as second-line treatment to reduce the risk for fractures. Remember, bisphosphonates and denosumab are antiresorptive drugs, meaning they slow the progression of osteoporosis. The anabolic drugs, on the other hand, such as the sclerostin inhibitor romosozumab and recombinant human parathyroid hormone (PTH) teriparatide, increase bone density. The anabolic agents should be used only in women with primary osteoporosis who are at very high risk for fractures, and use of these agents always needs to be followed by an antiresorptive agent, because otherwise there’s a risk for rebound osteoporosis and an increased risk for vertebral fractures.

Now, how about osteopenia? The guidelines recommend that for women over 65 with osteopenia, use an individualized approach influenced by the level of risk for fracture, including increased age, low body weight, current smoking, hip fracture in a parent, fall risk, and a personal history of fracture. The guidelines note that increasing the duration of bisphosphonate therapy beyond 3-5 years does reduce the risk for new vertebral fractures, but it doesn’t reduce the risk for other fractures and it increases the risk for osteonecrosis of the jaw and atypical hip fractures. Therefore, the guidelines say that we should use bisphosphonates only for 3-5 years unless someone is at extremely high risk. It’s also important to note that there’s a fivefold higher risk for atypical femoral fractures among Asian women.

Don’t forget about adequate vitamin D and calcium. And most importantly, don’t forget about exercise, particularly exercise aimed at improving balance and quadriceps strength, which helps prevent falls.
 

Dr. Skolnik is professor, department of family medicine, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director, department of family medicine, Abington (Pa.) Jefferson Health. He disclosed ties with AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Sanofi, Sanofi Pasteur, and Teva.

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

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Unawareness of memory slips could indicate risk for Alzheimer’s

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Changed
Fri, 04/28/2023 - 08:26

Everyone’s memory fades to some extent as we age, but not everyone will develop Alzheimer’s disease. Screening the most likely people to develop Alzheimer’s remains an ongoing challenge, as some people present only unambiguous symptoms once their disease is advanced.

A new study in JAMA Network Open suggests that one early clue is found in people’s own self-perception of their memory skills. People who are more aware of their own declining memory capacity are less likely to develop Alzheimer’s, the study suggests.

“Some people are very aware of changes in their memory, but many people are unaware,” said study author Patrizia Vannini, PhD, a neurologist at Brigham and Women’s Hospital in Boston. There are gradations of unawareness of memory loss, Dr. Vannini said, from complete unawareness that anything is wrong, to a partial unawareness that memory is declining.

The study compared the records of 436 participants in the Alzheimer’s Disease Neuroimaging Initiative, an Alzheimer’s research institute housed at the University of Southern California. More than 90% of the participants were White, and generally had a college education. Their average age was 75 years, and 53% of participants were women.

Dr. Vannini and colleagues tracked people whose cognitive function was normal at the beginning of the study, based on the Clinical Dementia Rating. Throughout the course of the study, which included data from 2010 to 2021, 91 of the 436 participants experienced a sustained decline in their Clinical Dementia Rating scores, indicating a risk for eventual Alzheimer’s, whereas the other participants held steady.

The people who declined in cognitive function were less aware of slips in their memory, as assessed by discrepancies between people’s self-reports of their own memory skills and the perceptions of someone in their lives. For this part of the study, Dr. Vannini and colleagues used the Everyday Cognition Questionnaire, which evaluates memory tasks such as shopping without a grocery list or recalling conversations from a few days ago. Both the participant and the study partner rated their performance on such tasks compared to 10 years earlier. Those who were less aware of their memory slips were more likely to experience declines in the Clinical Dementia Rating, compared with people with a heightened concern about memory loss (as measured by being more concerned about memory decline than their study partners).

“Partial or complete unawareness is often related to delayed diagnosis of Alzheimer’s, because the patient is unaware they are having problems,” Dr. Vannini said, adding that this is associated with a poorer prognosis as well.
 

Implications for clinicians

Soo Borson, MD, professor of clinical family medicine at the University of Southern California and coleader of a CDC-funded early dementia detection center at New York University, pointed out that sometimes people are genuinely unaware that their memory is declining, while at other times they know it all too well but say everything is fine when a doctor asks about their current memory status. That may be because people fear the label of “Alzheimer’s,” Dr. Borson suggested, or simply because they don’t want to start a protracted diagnostic pathway that could involve lots of tests and time.

Dr. Borson, who was not involved in the study, noted that the population was predominantly White and well-educated, and by definition included people who were concerned enough about potential memory loss to become part of an Alzheimer’s research network. This limits the generalizability of this study’s results to other populations, Dr. Borson said.

Despite that limitation, in Dr. Borson’s view the study points to the continued importance of clinicians (ideally a primary care doctor who knows the patient well) engaging with patients about their brain health once they reach midlife. A doctor could ask if patients have noticed a decline in their thinking or memory over the last year, for example, or a more open-ended question about any memory concerns.

Although some patients may choose to withhold concerns about their memory, Dr. Borson acknowledged, the overall thrust of these questions is to provide a safe space for patients to air their concerns if they so choose. In some cases it would be appropriate to do a simple memory test on the spot, and then proceed accordingly – either for further tests if something of concern emerges, or to reassure the patient if the test doesn’t yield anything of note. In the latter case some patients will still want further tests for additional reassurance, and Dr. Borson thinks doctors should facilitate that request even if in their own judgment nothing is wrong.

“This is not like testing for impaired kidney function by doing a serum creatinine test,” Dr. Borson said. While the orientation of the health care system is toward quick and easy answers for everything, detecting possible dementia eludes such an approach.

Dr. Vannini reports funding from the National Institutes of Health National Institute on Aging. Dr. Borson reported no disclosures.

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Everyone’s memory fades to some extent as we age, but not everyone will develop Alzheimer’s disease. Screening the most likely people to develop Alzheimer’s remains an ongoing challenge, as some people present only unambiguous symptoms once their disease is advanced.

A new study in JAMA Network Open suggests that one early clue is found in people’s own self-perception of their memory skills. People who are more aware of their own declining memory capacity are less likely to develop Alzheimer’s, the study suggests.

“Some people are very aware of changes in their memory, but many people are unaware,” said study author Patrizia Vannini, PhD, a neurologist at Brigham and Women’s Hospital in Boston. There are gradations of unawareness of memory loss, Dr. Vannini said, from complete unawareness that anything is wrong, to a partial unawareness that memory is declining.

The study compared the records of 436 participants in the Alzheimer’s Disease Neuroimaging Initiative, an Alzheimer’s research institute housed at the University of Southern California. More than 90% of the participants were White, and generally had a college education. Their average age was 75 years, and 53% of participants were women.

Dr. Vannini and colleagues tracked people whose cognitive function was normal at the beginning of the study, based on the Clinical Dementia Rating. Throughout the course of the study, which included data from 2010 to 2021, 91 of the 436 participants experienced a sustained decline in their Clinical Dementia Rating scores, indicating a risk for eventual Alzheimer’s, whereas the other participants held steady.

The people who declined in cognitive function were less aware of slips in their memory, as assessed by discrepancies between people’s self-reports of their own memory skills and the perceptions of someone in their lives. For this part of the study, Dr. Vannini and colleagues used the Everyday Cognition Questionnaire, which evaluates memory tasks such as shopping without a grocery list or recalling conversations from a few days ago. Both the participant and the study partner rated their performance on such tasks compared to 10 years earlier. Those who were less aware of their memory slips were more likely to experience declines in the Clinical Dementia Rating, compared with people with a heightened concern about memory loss (as measured by being more concerned about memory decline than their study partners).

“Partial or complete unawareness is often related to delayed diagnosis of Alzheimer’s, because the patient is unaware they are having problems,” Dr. Vannini said, adding that this is associated with a poorer prognosis as well.
 

Implications for clinicians

Soo Borson, MD, professor of clinical family medicine at the University of Southern California and coleader of a CDC-funded early dementia detection center at New York University, pointed out that sometimes people are genuinely unaware that their memory is declining, while at other times they know it all too well but say everything is fine when a doctor asks about their current memory status. That may be because people fear the label of “Alzheimer’s,” Dr. Borson suggested, or simply because they don’t want to start a protracted diagnostic pathway that could involve lots of tests and time.

Dr. Borson, who was not involved in the study, noted that the population was predominantly White and well-educated, and by definition included people who were concerned enough about potential memory loss to become part of an Alzheimer’s research network. This limits the generalizability of this study’s results to other populations, Dr. Borson said.

Despite that limitation, in Dr. Borson’s view the study points to the continued importance of clinicians (ideally a primary care doctor who knows the patient well) engaging with patients about their brain health once they reach midlife. A doctor could ask if patients have noticed a decline in their thinking or memory over the last year, for example, or a more open-ended question about any memory concerns.

Although some patients may choose to withhold concerns about their memory, Dr. Borson acknowledged, the overall thrust of these questions is to provide a safe space for patients to air their concerns if they so choose. In some cases it would be appropriate to do a simple memory test on the spot, and then proceed accordingly – either for further tests if something of concern emerges, or to reassure the patient if the test doesn’t yield anything of note. In the latter case some patients will still want further tests for additional reassurance, and Dr. Borson thinks doctors should facilitate that request even if in their own judgment nothing is wrong.

“This is not like testing for impaired kidney function by doing a serum creatinine test,” Dr. Borson said. While the orientation of the health care system is toward quick and easy answers for everything, detecting possible dementia eludes such an approach.

Dr. Vannini reports funding from the National Institutes of Health National Institute on Aging. Dr. Borson reported no disclosures.

Everyone’s memory fades to some extent as we age, but not everyone will develop Alzheimer’s disease. Screening the most likely people to develop Alzheimer’s remains an ongoing challenge, as some people present only unambiguous symptoms once their disease is advanced.

A new study in JAMA Network Open suggests that one early clue is found in people’s own self-perception of their memory skills. People who are more aware of their own declining memory capacity are less likely to develop Alzheimer’s, the study suggests.

“Some people are very aware of changes in their memory, but many people are unaware,” said study author Patrizia Vannini, PhD, a neurologist at Brigham and Women’s Hospital in Boston. There are gradations of unawareness of memory loss, Dr. Vannini said, from complete unawareness that anything is wrong, to a partial unawareness that memory is declining.

The study compared the records of 436 participants in the Alzheimer’s Disease Neuroimaging Initiative, an Alzheimer’s research institute housed at the University of Southern California. More than 90% of the participants were White, and generally had a college education. Their average age was 75 years, and 53% of participants were women.

Dr. Vannini and colleagues tracked people whose cognitive function was normal at the beginning of the study, based on the Clinical Dementia Rating. Throughout the course of the study, which included data from 2010 to 2021, 91 of the 436 participants experienced a sustained decline in their Clinical Dementia Rating scores, indicating a risk for eventual Alzheimer’s, whereas the other participants held steady.

The people who declined in cognitive function were less aware of slips in their memory, as assessed by discrepancies between people’s self-reports of their own memory skills and the perceptions of someone in their lives. For this part of the study, Dr. Vannini and colleagues used the Everyday Cognition Questionnaire, which evaluates memory tasks such as shopping without a grocery list or recalling conversations from a few days ago. Both the participant and the study partner rated their performance on such tasks compared to 10 years earlier. Those who were less aware of their memory slips were more likely to experience declines in the Clinical Dementia Rating, compared with people with a heightened concern about memory loss (as measured by being more concerned about memory decline than their study partners).

“Partial or complete unawareness is often related to delayed diagnosis of Alzheimer’s, because the patient is unaware they are having problems,” Dr. Vannini said, adding that this is associated with a poorer prognosis as well.
 

Implications for clinicians

Soo Borson, MD, professor of clinical family medicine at the University of Southern California and coleader of a CDC-funded early dementia detection center at New York University, pointed out that sometimes people are genuinely unaware that their memory is declining, while at other times they know it all too well but say everything is fine when a doctor asks about their current memory status. That may be because people fear the label of “Alzheimer’s,” Dr. Borson suggested, or simply because they don’t want to start a protracted diagnostic pathway that could involve lots of tests and time.

Dr. Borson, who was not involved in the study, noted that the population was predominantly White and well-educated, and by definition included people who were concerned enough about potential memory loss to become part of an Alzheimer’s research network. This limits the generalizability of this study’s results to other populations, Dr. Borson said.

Despite that limitation, in Dr. Borson’s view the study points to the continued importance of clinicians (ideally a primary care doctor who knows the patient well) engaging with patients about their brain health once they reach midlife. A doctor could ask if patients have noticed a decline in their thinking or memory over the last year, for example, or a more open-ended question about any memory concerns.

Although some patients may choose to withhold concerns about their memory, Dr. Borson acknowledged, the overall thrust of these questions is to provide a safe space for patients to air their concerns if they so choose. In some cases it would be appropriate to do a simple memory test on the spot, and then proceed accordingly – either for further tests if something of concern emerges, or to reassure the patient if the test doesn’t yield anything of note. In the latter case some patients will still want further tests for additional reassurance, and Dr. Borson thinks doctors should facilitate that request even if in their own judgment nothing is wrong.

“This is not like testing for impaired kidney function by doing a serum creatinine test,” Dr. Borson said. While the orientation of the health care system is toward quick and easy answers for everything, detecting possible dementia eludes such an approach.

Dr. Vannini reports funding from the National Institutes of Health National Institute on Aging. Dr. Borson reported no disclosures.

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Food insecurity linked to more rapid cognitive decline in seniors

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Changed
Fri, 04/14/2023 - 14:23

Food insecurity is linked to a more rapid decline in executive function in older adults, a new study shows.

The findings were reported just weeks after a pandemic-era expansion in Supplemental Nutrition Assistance Program benefits ended, leading to less food assistance for about 5 million people over age 60 who participate in the program.

“Even though we found only a very small association between food insecurity and executive function, it’s still meaningful, because food insecurity is something we can prevent,” lead investigator Boeun Kim, PhD, MPH, RN, postdoctoral fellow at Johns Hopkins University School of Nursing, Baltimore, told this news organization.

The findings were published online  in JAMA Network Open.
 

National data

The number of Americans over 60 with food insecurity has more than doubled since 2007, with an estimated 5.2 million older adults reporting food insecurity in 2020.

Prior studies have linked malnutrition and food insecurity to a decline in cognitive function. Participating in food assistance programs such as SNAP is associated with slower memory decline in older adults.

However, to date, there has been no longitudinal study that has used data from a nationally representative sample of older Americans, which, Dr. Kim said, could limit generalizability of the findings.

To address that issue, investigators analyzed data from 3,037 participants in the National Health and Aging Trends Study, which includes community dwellers age 65 and older who receive Medicare.

Participants reported food insecurity over 7 years, from 2012 to 2019. Data on immediate memory, delayed memory, and executive function were from 2013 to 2020.

Food insecurity was defined as going without groceries due to limited ability or social support; a lack of hot meals related to functional limitation or no help; going without eating because of the inability to feed oneself or no available support; skipping meals due to insufficient food or money; or skipping meals for 5 days or more.

Immediate and delayed recall were assessed using a 10-item word-list memory task, and executive function was measured using a clock drawing test. Each year’s cognitive functions were linked to the prior year’s food insecurity data.

Over 7 years, 417 people, or 12.1%, experienced food insecurity at least once.

Those with food insecurity were more likely to be older, female, part of racial and ethnic minority groups, living alone, obese, and have a lower income and educational attainment, depressive symptoms, social isolation and disability, compared with those without food insecurity.

After adjusting for age, sex, race/ethnicity, educational level, income, marital status, body mass index, functional disability, social isolation, and other potential confounders, researchers found that food insecurity was associated with a more rapid decline in executive function (mean difference in annual change in executive function score, −0.04; 95% confidence interval, −0.09 to −0.003).

Food insecurity was not associated with baseline cognitive function scores or changes in immediate or delayed recall.

“Clinicians should be aware of the experience of food insecurity and the higher risk of cognitive decline so maybe they could do universal screening and refer people with food insecurity to programs that can help them access nutritious meals,” Dr. Kim said.
 

A sign of other problems?

 

 

Thomas Vidic, MD, said food insecurity often goes hand-in-hand with lack of medication adherence, lack of regular medical care, and a host of other issues. Dr. Vidic is a neurologist at the Elkhart Clinic, Ind., and an adjunct clinical professor of neurology at Indiana University.

“When a person has food insecurity, they likely have other problems, and they’re going to degenerate faster,” said Dr. Vidic, who was not part of the study. “This is one important component, and it’s one more way of getting a handle on people who are failing.”

Dr. Vidic, who has dealt with the issue of food insecurity with his own patients, said he suspects the self-report nature of the study may hide the true scale of the problem.

“I suspect the numbers might actually be higher,” he said, adding that the study fills a gap in the literature with a large, nationally representative sample.

“We’re looking for issues to help with the elderly as far as what can we do to keep dementia from progressing,” he said. “There are some things that make sense, but we’ve never had this kind of data before.”

The study was funded by the National Institute on Aging. Dr. Kim and Dr. Vidic have reported no relevant financial relationships.

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

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Food insecurity is linked to a more rapid decline in executive function in older adults, a new study shows.

The findings were reported just weeks after a pandemic-era expansion in Supplemental Nutrition Assistance Program benefits ended, leading to less food assistance for about 5 million people over age 60 who participate in the program.

“Even though we found only a very small association between food insecurity and executive function, it’s still meaningful, because food insecurity is something we can prevent,” lead investigator Boeun Kim, PhD, MPH, RN, postdoctoral fellow at Johns Hopkins University School of Nursing, Baltimore, told this news organization.

The findings were published online  in JAMA Network Open.
 

National data

The number of Americans over 60 with food insecurity has more than doubled since 2007, with an estimated 5.2 million older adults reporting food insecurity in 2020.

Prior studies have linked malnutrition and food insecurity to a decline in cognitive function. Participating in food assistance programs such as SNAP is associated with slower memory decline in older adults.

However, to date, there has been no longitudinal study that has used data from a nationally representative sample of older Americans, which, Dr. Kim said, could limit generalizability of the findings.

To address that issue, investigators analyzed data from 3,037 participants in the National Health and Aging Trends Study, which includes community dwellers age 65 and older who receive Medicare.

Participants reported food insecurity over 7 years, from 2012 to 2019. Data on immediate memory, delayed memory, and executive function were from 2013 to 2020.

Food insecurity was defined as going without groceries due to limited ability or social support; a lack of hot meals related to functional limitation or no help; going without eating because of the inability to feed oneself or no available support; skipping meals due to insufficient food or money; or skipping meals for 5 days or more.

Immediate and delayed recall were assessed using a 10-item word-list memory task, and executive function was measured using a clock drawing test. Each year’s cognitive functions were linked to the prior year’s food insecurity data.

Over 7 years, 417 people, or 12.1%, experienced food insecurity at least once.

Those with food insecurity were more likely to be older, female, part of racial and ethnic minority groups, living alone, obese, and have a lower income and educational attainment, depressive symptoms, social isolation and disability, compared with those without food insecurity.

After adjusting for age, sex, race/ethnicity, educational level, income, marital status, body mass index, functional disability, social isolation, and other potential confounders, researchers found that food insecurity was associated with a more rapid decline in executive function (mean difference in annual change in executive function score, −0.04; 95% confidence interval, −0.09 to −0.003).

Food insecurity was not associated with baseline cognitive function scores or changes in immediate or delayed recall.

“Clinicians should be aware of the experience of food insecurity and the higher risk of cognitive decline so maybe they could do universal screening and refer people with food insecurity to programs that can help them access nutritious meals,” Dr. Kim said.
 

A sign of other problems?

 

 

Thomas Vidic, MD, said food insecurity often goes hand-in-hand with lack of medication adherence, lack of regular medical care, and a host of other issues. Dr. Vidic is a neurologist at the Elkhart Clinic, Ind., and an adjunct clinical professor of neurology at Indiana University.

“When a person has food insecurity, they likely have other problems, and they’re going to degenerate faster,” said Dr. Vidic, who was not part of the study. “This is one important component, and it’s one more way of getting a handle on people who are failing.”

Dr. Vidic, who has dealt with the issue of food insecurity with his own patients, said he suspects the self-report nature of the study may hide the true scale of the problem.

“I suspect the numbers might actually be higher,” he said, adding that the study fills a gap in the literature with a large, nationally representative sample.

“We’re looking for issues to help with the elderly as far as what can we do to keep dementia from progressing,” he said. “There are some things that make sense, but we’ve never had this kind of data before.”

The study was funded by the National Institute on Aging. Dr. Kim and Dr. Vidic have reported no relevant financial relationships.

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

Food insecurity is linked to a more rapid decline in executive function in older adults, a new study shows.

The findings were reported just weeks after a pandemic-era expansion in Supplemental Nutrition Assistance Program benefits ended, leading to less food assistance for about 5 million people over age 60 who participate in the program.

“Even though we found only a very small association between food insecurity and executive function, it’s still meaningful, because food insecurity is something we can prevent,” lead investigator Boeun Kim, PhD, MPH, RN, postdoctoral fellow at Johns Hopkins University School of Nursing, Baltimore, told this news organization.

The findings were published online  in JAMA Network Open.
 

National data

The number of Americans over 60 with food insecurity has more than doubled since 2007, with an estimated 5.2 million older adults reporting food insecurity in 2020.

Prior studies have linked malnutrition and food insecurity to a decline in cognitive function. Participating in food assistance programs such as SNAP is associated with slower memory decline in older adults.

However, to date, there has been no longitudinal study that has used data from a nationally representative sample of older Americans, which, Dr. Kim said, could limit generalizability of the findings.

To address that issue, investigators analyzed data from 3,037 participants in the National Health and Aging Trends Study, which includes community dwellers age 65 and older who receive Medicare.

Participants reported food insecurity over 7 years, from 2012 to 2019. Data on immediate memory, delayed memory, and executive function were from 2013 to 2020.

Food insecurity was defined as going without groceries due to limited ability or social support; a lack of hot meals related to functional limitation or no help; going without eating because of the inability to feed oneself or no available support; skipping meals due to insufficient food or money; or skipping meals for 5 days or more.

Immediate and delayed recall were assessed using a 10-item word-list memory task, and executive function was measured using a clock drawing test. Each year’s cognitive functions were linked to the prior year’s food insecurity data.

Over 7 years, 417 people, or 12.1%, experienced food insecurity at least once.

Those with food insecurity were more likely to be older, female, part of racial and ethnic minority groups, living alone, obese, and have a lower income and educational attainment, depressive symptoms, social isolation and disability, compared with those without food insecurity.

After adjusting for age, sex, race/ethnicity, educational level, income, marital status, body mass index, functional disability, social isolation, and other potential confounders, researchers found that food insecurity was associated with a more rapid decline in executive function (mean difference in annual change in executive function score, −0.04; 95% confidence interval, −0.09 to −0.003).

Food insecurity was not associated with baseline cognitive function scores or changes in immediate or delayed recall.

“Clinicians should be aware of the experience of food insecurity and the higher risk of cognitive decline so maybe they could do universal screening and refer people with food insecurity to programs that can help them access nutritious meals,” Dr. Kim said.
 

A sign of other problems?

 

 

Thomas Vidic, MD, said food insecurity often goes hand-in-hand with lack of medication adherence, lack of regular medical care, and a host of other issues. Dr. Vidic is a neurologist at the Elkhart Clinic, Ind., and an adjunct clinical professor of neurology at Indiana University.

“When a person has food insecurity, they likely have other problems, and they’re going to degenerate faster,” said Dr. Vidic, who was not part of the study. “This is one important component, and it’s one more way of getting a handle on people who are failing.”

Dr. Vidic, who has dealt with the issue of food insecurity with his own patients, said he suspects the self-report nature of the study may hide the true scale of the problem.

“I suspect the numbers might actually be higher,” he said, adding that the study fills a gap in the literature with a large, nationally representative sample.

“We’re looking for issues to help with the elderly as far as what can we do to keep dementia from progressing,” he said. “There are some things that make sense, but we’ve never had this kind of data before.”

The study was funded by the National Institute on Aging. Dr. Kim and Dr. Vidic have reported no relevant financial relationships.

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

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Parathyroidectomy does not preserve kidney function in seniors

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Fri, 04/14/2023 - 14:07

 

Early parathyroidectomy within 1 year of diagnosis of primary hyperparathyroidism (PHPT) did not reduce the risk of a sustained decline in kidney function, measured by a decline in estimated glomerular filtration rate (eGFR) of at least 50%, compared with observation (no surgery) in adults aged 60 and older.

Early parathyroidectomy was, however, associated with a reduced adjusted risk of this decline in kidney function in patients with newly diagnosed PHPT who were younger than age 60.

The findings, based on data from close to 43,000 veterans, were published online in Annals of Internal Medicine.

“The important takeaway from our study is that for older adults [age 60 or older] with primary hyperparathyroidism, preservation of kidney function should not be a primary consideration when making decisions about whether to undergo parathyroidectomy,” lead author Carolyn D. Seib, MD, told this news organization.

“It is important that physicians also discuss with their patients the potential long-term benefits of parathyroidectomy related to a reduced risk of fractures, kidney stones, and cardiovascular disease, and improved quality of life, in addition to the need for lifelong surveillance if surgery is declined, weighing these against an individual patient’s risk of surgery,” said Dr. Seib, a surgeon at Palo Alto (Calif.) VA Medical Center.

“However, in patients younger than 60, early parathyroidectomy may prevent progression to chronic kidney disease (CKD) and should be more strongly considered,” she noted.

Parathyroidectomy, she observed, is a low-risk outpatient surgery for most adults.

“Potential complications of surgery include temporary or permanent hoarseness, hypoparathyroidism (low postoperative parathyroid function), bleeding requiring return to the operating room, and complications related to general anesthesia, all of which are rare,” said Dr. Seib.

“Surgery by a high-volume surgeon is associated with a reduced risk of complications, so patients should seek out an experienced parathyroid surgeon,” she emphasized.  

Moreover, parathyroidectomy is the only treatment for primary hyperparathyroidism.
 

Does parathyroidectomy slow loss of kidney function?

Multidisciplinary guidelines recommend parathyroidectomy, at least in part to mitigate the risk for, and effects related to, the progression of CKD in patients with PHPT and an eGFR below 60 mL/min per 1.73 m2, the researchers wrote.

However, whether parathyroidectomy slows the loss of kidney function in adults with PHPT is not clear.

Guidelines also state that “observation for PHPT disease progression can be considered when patients have no obvious end organ damage (i.e., eGFR > 60 mL/min per 1.73 m2, normal bone mineral density, and no history of kidney stones or fractures),” Dr. Seib noted.  

To address the evidence gap, the researchers emulated a randomized target trial using observational data.

In this type of study, Dr. Seib explained, “although patients aren’t randomly assigned to a treatment, complex statistical methods are used to adjust for baseline confounders in an attempt to emulate random treatment assignment and account for bias that may affect the timing of when patients receive treatment.”

Using national Veterans Health Administration data, researchers identified 43,697 veterans with a new biochemical diagnosis of PHPT, defined as elevated parathyroid hormone (> 65 ng/mL) within 6 months of an elevated serum calcium level (> 32.55 mmol/L or >10.2 mg/dL), from 2000 to 2019.

Of these patients, 3,804 underwent parathyroidectomy within 1 year of diagnosis of PHPT, and 39,893 did not, and instead, a watchful waiting approach was adopted.

To be included in the analysis, patients had to have an eGFR above 30 mL/min per 1.73 m2 for 12 months before PHPT diagnosis to exclude secondary or tertiary hyperparathyroidism.

The primary outcome was a sustained decline in eGFR of at least 50% from baseline.

In the overall cohort, patients had a mean pretreatment eGFR of 71.8 mL/min per 1.73 m2. The mean age of patients was 67, 88% were men, and 68% were White.

After a median follow-up of 4.9 years, 6.7% of the patients had a decline in eGFR of at least 50%.

The cumulative incidence of this decline in eGFR was 5.1% at 5 years and 10.8% at 10 years in patients who had had early parathyroidectomy compared with 5.1% and 12.0%, respectively, in patients who did not undergo surgery.

In the overall population, the risk of at least a 50% decline in eGFR was similar in the early parathyroidectomy group versus the observation group (adjusted hazard ratio [HR], 0.98, 95% confidence interval [CI], 0.82-1.16).

However, diving deeper showed that parathyroidectomy was associated with a reduced risk of the primary outcome among patients younger than 60 years (adjusted HR, 0.75, 95% CI, 0.59-0.93) but not among those aged 60 or older (adjusted HR, 1.08, 95% CI, 0.87-1.34).

“When participating in shared decision-making for older adults [age 60 and older] with PHPT, clinicians should not consider parathyroidectomy for potential benefits of preservation of kidney function,” the researchers reiterated.

“For younger patients, clinicians should discuss the potential benefit of parathyroidectomy to reduce the risk for CKD and associated complications in adults with PHPT,” they concluded.

The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.

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

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Early parathyroidectomy within 1 year of diagnosis of primary hyperparathyroidism (PHPT) did not reduce the risk of a sustained decline in kidney function, measured by a decline in estimated glomerular filtration rate (eGFR) of at least 50%, compared with observation (no surgery) in adults aged 60 and older.

Early parathyroidectomy was, however, associated with a reduced adjusted risk of this decline in kidney function in patients with newly diagnosed PHPT who were younger than age 60.

The findings, based on data from close to 43,000 veterans, were published online in Annals of Internal Medicine.

“The important takeaway from our study is that for older adults [age 60 or older] with primary hyperparathyroidism, preservation of kidney function should not be a primary consideration when making decisions about whether to undergo parathyroidectomy,” lead author Carolyn D. Seib, MD, told this news organization.

“It is important that physicians also discuss with their patients the potential long-term benefits of parathyroidectomy related to a reduced risk of fractures, kidney stones, and cardiovascular disease, and improved quality of life, in addition to the need for lifelong surveillance if surgery is declined, weighing these against an individual patient’s risk of surgery,” said Dr. Seib, a surgeon at Palo Alto (Calif.) VA Medical Center.

“However, in patients younger than 60, early parathyroidectomy may prevent progression to chronic kidney disease (CKD) and should be more strongly considered,” she noted.

Parathyroidectomy, she observed, is a low-risk outpatient surgery for most adults.

“Potential complications of surgery include temporary or permanent hoarseness, hypoparathyroidism (low postoperative parathyroid function), bleeding requiring return to the operating room, and complications related to general anesthesia, all of which are rare,” said Dr. Seib.

“Surgery by a high-volume surgeon is associated with a reduced risk of complications, so patients should seek out an experienced parathyroid surgeon,” she emphasized.  

Moreover, parathyroidectomy is the only treatment for primary hyperparathyroidism.
 

Does parathyroidectomy slow loss of kidney function?

Multidisciplinary guidelines recommend parathyroidectomy, at least in part to mitigate the risk for, and effects related to, the progression of CKD in patients with PHPT and an eGFR below 60 mL/min per 1.73 m2, the researchers wrote.

However, whether parathyroidectomy slows the loss of kidney function in adults with PHPT is not clear.

Guidelines also state that “observation for PHPT disease progression can be considered when patients have no obvious end organ damage (i.e., eGFR > 60 mL/min per 1.73 m2, normal bone mineral density, and no history of kidney stones or fractures),” Dr. Seib noted.  

To address the evidence gap, the researchers emulated a randomized target trial using observational data.

In this type of study, Dr. Seib explained, “although patients aren’t randomly assigned to a treatment, complex statistical methods are used to adjust for baseline confounders in an attempt to emulate random treatment assignment and account for bias that may affect the timing of when patients receive treatment.”

Using national Veterans Health Administration data, researchers identified 43,697 veterans with a new biochemical diagnosis of PHPT, defined as elevated parathyroid hormone (> 65 ng/mL) within 6 months of an elevated serum calcium level (> 32.55 mmol/L or >10.2 mg/dL), from 2000 to 2019.

Of these patients, 3,804 underwent parathyroidectomy within 1 year of diagnosis of PHPT, and 39,893 did not, and instead, a watchful waiting approach was adopted.

To be included in the analysis, patients had to have an eGFR above 30 mL/min per 1.73 m2 for 12 months before PHPT diagnosis to exclude secondary or tertiary hyperparathyroidism.

The primary outcome was a sustained decline in eGFR of at least 50% from baseline.

In the overall cohort, patients had a mean pretreatment eGFR of 71.8 mL/min per 1.73 m2. The mean age of patients was 67, 88% were men, and 68% were White.

After a median follow-up of 4.9 years, 6.7% of the patients had a decline in eGFR of at least 50%.

The cumulative incidence of this decline in eGFR was 5.1% at 5 years and 10.8% at 10 years in patients who had had early parathyroidectomy compared with 5.1% and 12.0%, respectively, in patients who did not undergo surgery.

In the overall population, the risk of at least a 50% decline in eGFR was similar in the early parathyroidectomy group versus the observation group (adjusted hazard ratio [HR], 0.98, 95% confidence interval [CI], 0.82-1.16).

However, diving deeper showed that parathyroidectomy was associated with a reduced risk of the primary outcome among patients younger than 60 years (adjusted HR, 0.75, 95% CI, 0.59-0.93) but not among those aged 60 or older (adjusted HR, 1.08, 95% CI, 0.87-1.34).

“When participating in shared decision-making for older adults [age 60 and older] with PHPT, clinicians should not consider parathyroidectomy for potential benefits of preservation of kidney function,” the researchers reiterated.

“For younger patients, clinicians should discuss the potential benefit of parathyroidectomy to reduce the risk for CKD and associated complications in adults with PHPT,” they concluded.

The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.

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

 

Early parathyroidectomy within 1 year of diagnosis of primary hyperparathyroidism (PHPT) did not reduce the risk of a sustained decline in kidney function, measured by a decline in estimated glomerular filtration rate (eGFR) of at least 50%, compared with observation (no surgery) in adults aged 60 and older.

Early parathyroidectomy was, however, associated with a reduced adjusted risk of this decline in kidney function in patients with newly diagnosed PHPT who were younger than age 60.

The findings, based on data from close to 43,000 veterans, were published online in Annals of Internal Medicine.

“The important takeaway from our study is that for older adults [age 60 or older] with primary hyperparathyroidism, preservation of kidney function should not be a primary consideration when making decisions about whether to undergo parathyroidectomy,” lead author Carolyn D. Seib, MD, told this news organization.

“It is important that physicians also discuss with their patients the potential long-term benefits of parathyroidectomy related to a reduced risk of fractures, kidney stones, and cardiovascular disease, and improved quality of life, in addition to the need for lifelong surveillance if surgery is declined, weighing these against an individual patient’s risk of surgery,” said Dr. Seib, a surgeon at Palo Alto (Calif.) VA Medical Center.

“However, in patients younger than 60, early parathyroidectomy may prevent progression to chronic kidney disease (CKD) and should be more strongly considered,” she noted.

Parathyroidectomy, she observed, is a low-risk outpatient surgery for most adults.

“Potential complications of surgery include temporary or permanent hoarseness, hypoparathyroidism (low postoperative parathyroid function), bleeding requiring return to the operating room, and complications related to general anesthesia, all of which are rare,” said Dr. Seib.

“Surgery by a high-volume surgeon is associated with a reduced risk of complications, so patients should seek out an experienced parathyroid surgeon,” she emphasized.  

Moreover, parathyroidectomy is the only treatment for primary hyperparathyroidism.
 

Does parathyroidectomy slow loss of kidney function?

Multidisciplinary guidelines recommend parathyroidectomy, at least in part to mitigate the risk for, and effects related to, the progression of CKD in patients with PHPT and an eGFR below 60 mL/min per 1.73 m2, the researchers wrote.

However, whether parathyroidectomy slows the loss of kidney function in adults with PHPT is not clear.

Guidelines also state that “observation for PHPT disease progression can be considered when patients have no obvious end organ damage (i.e., eGFR > 60 mL/min per 1.73 m2, normal bone mineral density, and no history of kidney stones or fractures),” Dr. Seib noted.  

To address the evidence gap, the researchers emulated a randomized target trial using observational data.

In this type of study, Dr. Seib explained, “although patients aren’t randomly assigned to a treatment, complex statistical methods are used to adjust for baseline confounders in an attempt to emulate random treatment assignment and account for bias that may affect the timing of when patients receive treatment.”

Using national Veterans Health Administration data, researchers identified 43,697 veterans with a new biochemical diagnosis of PHPT, defined as elevated parathyroid hormone (> 65 ng/mL) within 6 months of an elevated serum calcium level (> 32.55 mmol/L or >10.2 mg/dL), from 2000 to 2019.

Of these patients, 3,804 underwent parathyroidectomy within 1 year of diagnosis of PHPT, and 39,893 did not, and instead, a watchful waiting approach was adopted.

To be included in the analysis, patients had to have an eGFR above 30 mL/min per 1.73 m2 for 12 months before PHPT diagnosis to exclude secondary or tertiary hyperparathyroidism.

The primary outcome was a sustained decline in eGFR of at least 50% from baseline.

In the overall cohort, patients had a mean pretreatment eGFR of 71.8 mL/min per 1.73 m2. The mean age of patients was 67, 88% were men, and 68% were White.

After a median follow-up of 4.9 years, 6.7% of the patients had a decline in eGFR of at least 50%.

The cumulative incidence of this decline in eGFR was 5.1% at 5 years and 10.8% at 10 years in patients who had had early parathyroidectomy compared with 5.1% and 12.0%, respectively, in patients who did not undergo surgery.

In the overall population, the risk of at least a 50% decline in eGFR was similar in the early parathyroidectomy group versus the observation group (adjusted hazard ratio [HR], 0.98, 95% confidence interval [CI], 0.82-1.16).

However, diving deeper showed that parathyroidectomy was associated with a reduced risk of the primary outcome among patients younger than 60 years (adjusted HR, 0.75, 95% CI, 0.59-0.93) but not among those aged 60 or older (adjusted HR, 1.08, 95% CI, 0.87-1.34).

“When participating in shared decision-making for older adults [age 60 and older] with PHPT, clinicians should not consider parathyroidectomy for potential benefits of preservation of kidney function,” the researchers reiterated.

“For younger patients, clinicians should discuss the potential benefit of parathyroidectomy to reduce the risk for CKD and associated complications in adults with PHPT,” they concluded.

The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.

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

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Self-fitted and audiologist-fitted hearing aids equal for mild to moderate hearing loss

Article Type
Changed
Thu, 04/13/2023 - 11:15

Self-fitted over-the-counter (OTC) hearing aids may be an effective option for individuals with mild to moderate hearing loss, a small randomized effectiveness trial reports. OTC devices yielded 6-week patient-perceived and clinical outcomes comparable to those with audiologist-fitted hearing aids, In fact, at week 2, the self-fitted group had a small but meaningful advantage on two of the four study outcome measures.

“After support and fine-tuning were provided to the self-fitting (remote support) and audiologist-fitted groups, no clinically meaningful differences were evident in any outcome measures at the end of the 6-week trial,” wrote researchers led by Karina C. De Sousa, PhD, a postdoctoral researcher in the department of speech-language pathology and audiology at the University of Pretoria, South Africa.

Dr. De Sousa
Dr. Karina C. De Sousa

Their findings appear in JAMA Otolaryngology–Head & Neck Surgery.

Hearing aid uptake is low even in populations with adequate access to audiological resources, the authors noted, with hearing aid use in U.S. adults who could benefit estimated at about 20%. Currently, an estimated 22.9 million older Americans with audiometric hearing loss do not use hearing aids.

Major barriers have been access and affordability, Dr. De Sousa and associates wrote, and until recently, people with hearing loss could obtain hearing aids only after consultation with a credentialed dispenser. “The World Health Organization estimates that over 2.5 billion people will experience some degree of hearing loss by 2050,” Dr. De Sousa said in an interview. “This new category of self-fitting hearing aids opens up newer care pathways for people with mild to moderate hearing loss.”
 

The study

From April to August 2022 the trial recruited 68 participants (51.6% men) with mild-to-moderate self-reported hearing loss, a mean age of 63.6 years, and no ear disease within the past 90 days. They were randomized to a self-fitted commercially available device (Lexi Lumen), with instructional material on set-up and remote support, or to the same unit fitted by an audiologist. The majority in both arms were new users and were similar in age and baseline hearing scores.

The primary outcome measure was patient-reported hearing aid benefit, measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. This scale evaluates auditory acuity before and after amplification by such criteria as ease of communication, background noise, reverberation, aversiveness, and global hearing status.

Secondary measures included the International Outcome Inventory for Hearing Aids (IOI-HA) and speech recognition in noise measured using an abbreviated speech-in-noise test and a digits-in-noise test. Measures were taken at baseline, week 2, and week 6 after fitting. After the 2-week field trial, the self-fitting arm had an initial advantage on the self-reported APHAB: difference, Cohen d = −.5 (95% confidence interval [CI], −1.0 to 0). It also fared better on the IOI-HA: effect size, r = 0.3 (95% CI, .0 to –.5), but not on speech recognition in noise.

One member of the self-fitting arm withdrew owing to an unrelated middle-ear infection.

“While these results are promising, it is essential to note that OTC hearing aids are not a one-size-fits-all approach,” Dr. De Sousa said. “If a person has ear disease symptoms or hearing loss that is too severe, they have to consult a trained hearing health care professional.” She added that proper use of a self-fitted OTC hearing aid requires a degree of digital proficiency, as many devices are set up using a smartphone.

This study was supported by the National Institutes of Health and by the hearX Group, which provided the Lexie Lumen devices and software support for data collection. Dr. De Sousa reported nonfinancial support from hearX as well as consulting fees from hearX outside of the submitted work. A coauthor reported grant support from the UK’s National Institute for Health and Care Research Manchester Biomedical Research Centre, and fees from hearX during and outside of the study. Another coauthor disclosed fees, equity, and grant support from hearX during the conduct of the study.

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Self-fitted over-the-counter (OTC) hearing aids may be an effective option for individuals with mild to moderate hearing loss, a small randomized effectiveness trial reports. OTC devices yielded 6-week patient-perceived and clinical outcomes comparable to those with audiologist-fitted hearing aids, In fact, at week 2, the self-fitted group had a small but meaningful advantage on two of the four study outcome measures.

“After support and fine-tuning were provided to the self-fitting (remote support) and audiologist-fitted groups, no clinically meaningful differences were evident in any outcome measures at the end of the 6-week trial,” wrote researchers led by Karina C. De Sousa, PhD, a postdoctoral researcher in the department of speech-language pathology and audiology at the University of Pretoria, South Africa.

Dr. De Sousa
Dr. Karina C. De Sousa

Their findings appear in JAMA Otolaryngology–Head & Neck Surgery.

Hearing aid uptake is low even in populations with adequate access to audiological resources, the authors noted, with hearing aid use in U.S. adults who could benefit estimated at about 20%. Currently, an estimated 22.9 million older Americans with audiometric hearing loss do not use hearing aids.

Major barriers have been access and affordability, Dr. De Sousa and associates wrote, and until recently, people with hearing loss could obtain hearing aids only after consultation with a credentialed dispenser. “The World Health Organization estimates that over 2.5 billion people will experience some degree of hearing loss by 2050,” Dr. De Sousa said in an interview. “This new category of self-fitting hearing aids opens up newer care pathways for people with mild to moderate hearing loss.”
 

The study

From April to August 2022 the trial recruited 68 participants (51.6% men) with mild-to-moderate self-reported hearing loss, a mean age of 63.6 years, and no ear disease within the past 90 days. They were randomized to a self-fitted commercially available device (Lexi Lumen), with instructional material on set-up and remote support, or to the same unit fitted by an audiologist. The majority in both arms were new users and were similar in age and baseline hearing scores.

The primary outcome measure was patient-reported hearing aid benefit, measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. This scale evaluates auditory acuity before and after amplification by such criteria as ease of communication, background noise, reverberation, aversiveness, and global hearing status.

Secondary measures included the International Outcome Inventory for Hearing Aids (IOI-HA) and speech recognition in noise measured using an abbreviated speech-in-noise test and a digits-in-noise test. Measures were taken at baseline, week 2, and week 6 after fitting. After the 2-week field trial, the self-fitting arm had an initial advantage on the self-reported APHAB: difference, Cohen d = −.5 (95% confidence interval [CI], −1.0 to 0). It also fared better on the IOI-HA: effect size, r = 0.3 (95% CI, .0 to –.5), but not on speech recognition in noise.

One member of the self-fitting arm withdrew owing to an unrelated middle-ear infection.

“While these results are promising, it is essential to note that OTC hearing aids are not a one-size-fits-all approach,” Dr. De Sousa said. “If a person has ear disease symptoms or hearing loss that is too severe, they have to consult a trained hearing health care professional.” She added that proper use of a self-fitted OTC hearing aid requires a degree of digital proficiency, as many devices are set up using a smartphone.

This study was supported by the National Institutes of Health and by the hearX Group, which provided the Lexie Lumen devices and software support for data collection. Dr. De Sousa reported nonfinancial support from hearX as well as consulting fees from hearX outside of the submitted work. A coauthor reported grant support from the UK’s National Institute for Health and Care Research Manchester Biomedical Research Centre, and fees from hearX during and outside of the study. Another coauthor disclosed fees, equity, and grant support from hearX during the conduct of the study.

Self-fitted over-the-counter (OTC) hearing aids may be an effective option for individuals with mild to moderate hearing loss, a small randomized effectiveness trial reports. OTC devices yielded 6-week patient-perceived and clinical outcomes comparable to those with audiologist-fitted hearing aids, In fact, at week 2, the self-fitted group had a small but meaningful advantage on two of the four study outcome measures.

“After support and fine-tuning were provided to the self-fitting (remote support) and audiologist-fitted groups, no clinically meaningful differences were evident in any outcome measures at the end of the 6-week trial,” wrote researchers led by Karina C. De Sousa, PhD, a postdoctoral researcher in the department of speech-language pathology and audiology at the University of Pretoria, South Africa.

Dr. De Sousa
Dr. Karina C. De Sousa

Their findings appear in JAMA Otolaryngology–Head & Neck Surgery.

Hearing aid uptake is low even in populations with adequate access to audiological resources, the authors noted, with hearing aid use in U.S. adults who could benefit estimated at about 20%. Currently, an estimated 22.9 million older Americans with audiometric hearing loss do not use hearing aids.

Major barriers have been access and affordability, Dr. De Sousa and associates wrote, and until recently, people with hearing loss could obtain hearing aids only after consultation with a credentialed dispenser. “The World Health Organization estimates that over 2.5 billion people will experience some degree of hearing loss by 2050,” Dr. De Sousa said in an interview. “This new category of self-fitting hearing aids opens up newer care pathways for people with mild to moderate hearing loss.”
 

The study

From April to August 2022 the trial recruited 68 participants (51.6% men) with mild-to-moderate self-reported hearing loss, a mean age of 63.6 years, and no ear disease within the past 90 days. They were randomized to a self-fitted commercially available device (Lexi Lumen), with instructional material on set-up and remote support, or to the same unit fitted by an audiologist. The majority in both arms were new users and were similar in age and baseline hearing scores.

The primary outcome measure was patient-reported hearing aid benefit, measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. This scale evaluates auditory acuity before and after amplification by such criteria as ease of communication, background noise, reverberation, aversiveness, and global hearing status.

Secondary measures included the International Outcome Inventory for Hearing Aids (IOI-HA) and speech recognition in noise measured using an abbreviated speech-in-noise test and a digits-in-noise test. Measures were taken at baseline, week 2, and week 6 after fitting. After the 2-week field trial, the self-fitting arm had an initial advantage on the self-reported APHAB: difference, Cohen d = −.5 (95% confidence interval [CI], −1.0 to 0). It also fared better on the IOI-HA: effect size, r = 0.3 (95% CI, .0 to –.5), but not on speech recognition in noise.

One member of the self-fitting arm withdrew owing to an unrelated middle-ear infection.

“While these results are promising, it is essential to note that OTC hearing aids are not a one-size-fits-all approach,” Dr. De Sousa said. “If a person has ear disease symptoms or hearing loss that is too severe, they have to consult a trained hearing health care professional.” She added that proper use of a self-fitted OTC hearing aid requires a degree of digital proficiency, as many devices are set up using a smartphone.

This study was supported by the National Institutes of Health and by the hearX Group, which provided the Lexie Lumen devices and software support for data collection. Dr. De Sousa reported nonfinancial support from hearX as well as consulting fees from hearX outside of the submitted work. A coauthor reported grant support from the UK’s National Institute for Health and Care Research Manchester Biomedical Research Centre, and fees from hearX during and outside of the study. Another coauthor disclosed fees, equity, and grant support from hearX during the conduct of the study.

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FROM JAMA OTOLARYNGOLOGY–HEAD & NECK SURGERY

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Urban green and blue spaces linked to less psychological distress

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Mon, 04/17/2023 - 09:15

Older adults in cities are at lower risk of serious psychological distress – and potentially of later cognitive impairment and dementia – when they live close to so-called green and blue spaces, which can include public parks, community gardens, cemeteries, and bodies of water.

The findings of the study, which was released ahead of its scheduled presentation at the annual meeting of the American Academy of Neurology, build on a growing understanding of the relationship between types and qualities of urban environments and dementia risk.

Adithya Vegaraju

Adithya Vegaraju, a student at Washington State University, Spokane, led the study, which looked at data from the Washington State Behavioral Risk Factor Surveillance System to assess prevalence of serious psychological distress among 42,980 Washington state residents aged 65 and over.

The data, collected between 2011 and 2019, used a self-reported questionnaire to determine serious psychological distress, which is defined as a level of mental distress considered debilitating enough to warrant treatment.

Mr. Vegaraju and his coauthor Solmaz Amiri, DDes, also of Washington State University, used ZIP codes, along with U.S. census data, to approximate the urban adults’ proximity to green and blue spaces.

After controlling for potential confounders of age, sex, ethnicity, education, and marital status, the investigators found that people living within half a mile of green or blue spaces had a 17% lower risk of experiencing serious psychological distress, compared with people living farther from these spaces, the investigators said in a news release.
 

Implications for cognitive decline and dementia?

Psychological distress in adults has been linked in population-based longitudinal studies to later cognitive decline and dementia. One study in older adults found the risk of dementia to be more than 50% higher among adults aged 50-70 with persistent depression. Blue and green spaces have also been investigated in relation to neurodegenerative disease among older adults; a 2022 study looking at data from some 62 million Medicare beneficiaries found those living in areas with more vegetation saw lower risk of hospitalizations for Alzheimer’s disease and related dementias.

“Since we lack effective prevention methods or treatments for mild cognitive impairment and dementia, we need to get creative in how we look at these issues,” Dr. Amiri commented in a press statement about her and Mr. Vegaraju’s findings. “Our hope is that this study showing better mental health among people living close to parks and water will trigger other studies about how these benefits work and whether this proximity can help prevent or delay mild cognitive impairment and dementia.”

The investigators acknowledged that their findings were limited by reliance on a self-reported measure of psychological distress.
 

A bidirectional connection with depression and dementia

In a comment, Anjum Hajat, PhD, an epidemiologist at University of Washington School of Public Health in Seattle who has also studied the relationship between green space and dementia risk in older adults, noted some further apparent limitations of the new study, for which only an abstract was available at publication.

Dr. Anjum Hajat

“It has been shown that people with depression are at higher risk for dementia, but the opposite is also true,” Dr. Hajat commented. “Those with dementia are more likely to develop depression. This bidirectionality makes this study abstract difficult to interpret since the study is based on cross-sectional data: Individuals are not followed over time to see which develops first, dementia or depression.”

Additionally, Dr. Hajat noted, the data used to determine proximity to green and blue spaces did not allow for the calculation of precise distances between subjects’ homes and these spaces.

Mr. Vegaraju and Dr. Amiri’s study had no outside support, and the investigators declared no conflicts of interest. Dr. Hajat declared no conflicts of interest.

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Older adults in cities are at lower risk of serious psychological distress – and potentially of later cognitive impairment and dementia – when they live close to so-called green and blue spaces, which can include public parks, community gardens, cemeteries, and bodies of water.

The findings of the study, which was released ahead of its scheduled presentation at the annual meeting of the American Academy of Neurology, build on a growing understanding of the relationship between types and qualities of urban environments and dementia risk.

Adithya Vegaraju

Adithya Vegaraju, a student at Washington State University, Spokane, led the study, which looked at data from the Washington State Behavioral Risk Factor Surveillance System to assess prevalence of serious psychological distress among 42,980 Washington state residents aged 65 and over.

The data, collected between 2011 and 2019, used a self-reported questionnaire to determine serious psychological distress, which is defined as a level of mental distress considered debilitating enough to warrant treatment.

Mr. Vegaraju and his coauthor Solmaz Amiri, DDes, also of Washington State University, used ZIP codes, along with U.S. census data, to approximate the urban adults’ proximity to green and blue spaces.

After controlling for potential confounders of age, sex, ethnicity, education, and marital status, the investigators found that people living within half a mile of green or blue spaces had a 17% lower risk of experiencing serious psychological distress, compared with people living farther from these spaces, the investigators said in a news release.
 

Implications for cognitive decline and dementia?

Psychological distress in adults has been linked in population-based longitudinal studies to later cognitive decline and dementia. One study in older adults found the risk of dementia to be more than 50% higher among adults aged 50-70 with persistent depression. Blue and green spaces have also been investigated in relation to neurodegenerative disease among older adults; a 2022 study looking at data from some 62 million Medicare beneficiaries found those living in areas with more vegetation saw lower risk of hospitalizations for Alzheimer’s disease and related dementias.

“Since we lack effective prevention methods or treatments for mild cognitive impairment and dementia, we need to get creative in how we look at these issues,” Dr. Amiri commented in a press statement about her and Mr. Vegaraju’s findings. “Our hope is that this study showing better mental health among people living close to parks and water will trigger other studies about how these benefits work and whether this proximity can help prevent or delay mild cognitive impairment and dementia.”

The investigators acknowledged that their findings were limited by reliance on a self-reported measure of psychological distress.
 

A bidirectional connection with depression and dementia

In a comment, Anjum Hajat, PhD, an epidemiologist at University of Washington School of Public Health in Seattle who has also studied the relationship between green space and dementia risk in older adults, noted some further apparent limitations of the new study, for which only an abstract was available at publication.

Dr. Anjum Hajat

“It has been shown that people with depression are at higher risk for dementia, but the opposite is also true,” Dr. Hajat commented. “Those with dementia are more likely to develop depression. This bidirectionality makes this study abstract difficult to interpret since the study is based on cross-sectional data: Individuals are not followed over time to see which develops first, dementia or depression.”

Additionally, Dr. Hajat noted, the data used to determine proximity to green and blue spaces did not allow for the calculation of precise distances between subjects’ homes and these spaces.

Mr. Vegaraju and Dr. Amiri’s study had no outside support, and the investigators declared no conflicts of interest. Dr. Hajat declared no conflicts of interest.

Older adults in cities are at lower risk of serious psychological distress – and potentially of later cognitive impairment and dementia – when they live close to so-called green and blue spaces, which can include public parks, community gardens, cemeteries, and bodies of water.

The findings of the study, which was released ahead of its scheduled presentation at the annual meeting of the American Academy of Neurology, build on a growing understanding of the relationship between types and qualities of urban environments and dementia risk.

Adithya Vegaraju

Adithya Vegaraju, a student at Washington State University, Spokane, led the study, which looked at data from the Washington State Behavioral Risk Factor Surveillance System to assess prevalence of serious psychological distress among 42,980 Washington state residents aged 65 and over.

The data, collected between 2011 and 2019, used a self-reported questionnaire to determine serious psychological distress, which is defined as a level of mental distress considered debilitating enough to warrant treatment.

Mr. Vegaraju and his coauthor Solmaz Amiri, DDes, also of Washington State University, used ZIP codes, along with U.S. census data, to approximate the urban adults’ proximity to green and blue spaces.

After controlling for potential confounders of age, sex, ethnicity, education, and marital status, the investigators found that people living within half a mile of green or blue spaces had a 17% lower risk of experiencing serious psychological distress, compared with people living farther from these spaces, the investigators said in a news release.
 

Implications for cognitive decline and dementia?

Psychological distress in adults has been linked in population-based longitudinal studies to later cognitive decline and dementia. One study in older adults found the risk of dementia to be more than 50% higher among adults aged 50-70 with persistent depression. Blue and green spaces have also been investigated in relation to neurodegenerative disease among older adults; a 2022 study looking at data from some 62 million Medicare beneficiaries found those living in areas with more vegetation saw lower risk of hospitalizations for Alzheimer’s disease and related dementias.

“Since we lack effective prevention methods or treatments for mild cognitive impairment and dementia, we need to get creative in how we look at these issues,” Dr. Amiri commented in a press statement about her and Mr. Vegaraju’s findings. “Our hope is that this study showing better mental health among people living close to parks and water will trigger other studies about how these benefits work and whether this proximity can help prevent or delay mild cognitive impairment and dementia.”

The investigators acknowledged that their findings were limited by reliance on a self-reported measure of psychological distress.
 

A bidirectional connection with depression and dementia

In a comment, Anjum Hajat, PhD, an epidemiologist at University of Washington School of Public Health in Seattle who has also studied the relationship between green space and dementia risk in older adults, noted some further apparent limitations of the new study, for which only an abstract was available at publication.

Dr. Anjum Hajat

“It has been shown that people with depression are at higher risk for dementia, but the opposite is also true,” Dr. Hajat commented. “Those with dementia are more likely to develop depression. This bidirectionality makes this study abstract difficult to interpret since the study is based on cross-sectional data: Individuals are not followed over time to see which develops first, dementia or depression.”

Additionally, Dr. Hajat noted, the data used to determine proximity to green and blue spaces did not allow for the calculation of precise distances between subjects’ homes and these spaces.

Mr. Vegaraju and Dr. Amiri’s study had no outside support, and the investigators declared no conflicts of interest. Dr. Hajat declared no conflicts of interest.

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FROM AAN 2023

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New Medicare rule streamlines prior authorization in Medicare Advantage plans

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Wed, 04/12/2023 - 09:53

A new federal rule seeks to reduce Medicare Advantage insurance plans’ prior authorization burdens on physicians while also ensuring that enrollees have the same access to necessary care that they would receive under traditional fee-for-service Medicare.

The prior authorization changes, announced this week, are part of the Centers for Medicare & Medicaid Services’ 2024 update of policy changes for Medicare Advantage and Part D pharmacy plans

Medicare Advantage plans’ business practices have raised significant concerns in recent years. More than 28 million Americans were enrolled in a Medicare Advantage plan in 2022, which is nearly half of all Medicare enrollees, according to the Kaiser Family Foundation.

Medicare pays a fixed amount per enrollee per year to these privately run managed care plans, in contrast to traditional fee-for-service Medicare. Medicare Advantage plans have been criticized for aggressive marketing, for overbilling the federal government for care, and for using prior authorization to inappropriately deny needed care to patients.

About 13% of prior authorization requests that are denied by Medicare Advantage plans actually met Medicare coverage rules and should have been approved, the Office of the Inspector General at the U.S. Department of Health & Human Services reported in 2022.

The newly finalized rule now requires Medicare Advantage plans to do the following.

  • Ensure that a prior authorization approval, once granted, remains valid for as long as medically necessary to avoid disruptions in care.
  • Conduct an annual review of utilization management policies.
  • Ensure that coverage denials based on medical necessity be reviewed by health care professionals with relevant expertise before a denial can be issued.

Physician groups welcomed the changes. In a statement, the American Medical Association said that an initial reading of the rule suggested CMS had “taken important steps toward right-sizing the prior authorization process.”

The Medical Group Management Association praised CMS in a statement for having limited “dangerous disruptions and delays to necessary patient care” resulting from the cumbersome processes of prior approval. With the new rules, CMS will provide greater consistency across Advantage plans as well as traditional Medicare, said Anders Gilberg, MGMA’s senior vice president of government affairs, in a statement.
 

Peer consideration

The final rule did disappoint physician groups in one key way. CMS rebuffed requests to have CMS require Advantage plans to use reviewers of the same specialty as treating physicians in handling disputes about prior authorization. CMS said it expects plans to exercise judgment in finding reviewers with “sufficient expertise to make an informed and supportable decision.”

“In some instances, we expect that plans will use a physician or other health care professional of the same specialty or subspecialty as the treating physician,” CMS said. “In other instances, we expect that plans will utilize a reviewer with specialized training, certification, or clinical experience in the applicable field of medicine.”
 

Medicare Advantage marketing ‘sowing confusion’

With this final rule, CMS also sought to protect consumers from “potentially misleading marketing practices” used in promoting Medicare Advantage and Part D prescription drug plans.

The agency said it had received complaints about people who have received official-looking promotional materials for Medicare that directed them not to government sources of information but to Medicare Advantage and Part D plans or their agents and brokers.

Ads now must mention a specific plan name, and they cannot use the Medicare name, CMS logo, Medicare card, or other government information in a misleading way, CMS said.

“CMS can see no value or purpose in a non-governmental entity’s use of the Medicare logo or HHS logo except for the express purpose of sowing confusion and misrepresenting itself as the government,” the agency said.

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

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A new federal rule seeks to reduce Medicare Advantage insurance plans’ prior authorization burdens on physicians while also ensuring that enrollees have the same access to necessary care that they would receive under traditional fee-for-service Medicare.

The prior authorization changes, announced this week, are part of the Centers for Medicare & Medicaid Services’ 2024 update of policy changes for Medicare Advantage and Part D pharmacy plans

Medicare Advantage plans’ business practices have raised significant concerns in recent years. More than 28 million Americans were enrolled in a Medicare Advantage plan in 2022, which is nearly half of all Medicare enrollees, according to the Kaiser Family Foundation.

Medicare pays a fixed amount per enrollee per year to these privately run managed care plans, in contrast to traditional fee-for-service Medicare. Medicare Advantage plans have been criticized for aggressive marketing, for overbilling the federal government for care, and for using prior authorization to inappropriately deny needed care to patients.

About 13% of prior authorization requests that are denied by Medicare Advantage plans actually met Medicare coverage rules and should have been approved, the Office of the Inspector General at the U.S. Department of Health & Human Services reported in 2022.

The newly finalized rule now requires Medicare Advantage plans to do the following.

  • Ensure that a prior authorization approval, once granted, remains valid for as long as medically necessary to avoid disruptions in care.
  • Conduct an annual review of utilization management policies.
  • Ensure that coverage denials based on medical necessity be reviewed by health care professionals with relevant expertise before a denial can be issued.

Physician groups welcomed the changes. In a statement, the American Medical Association said that an initial reading of the rule suggested CMS had “taken important steps toward right-sizing the prior authorization process.”

The Medical Group Management Association praised CMS in a statement for having limited “dangerous disruptions and delays to necessary patient care” resulting from the cumbersome processes of prior approval. With the new rules, CMS will provide greater consistency across Advantage plans as well as traditional Medicare, said Anders Gilberg, MGMA’s senior vice president of government affairs, in a statement.
 

Peer consideration

The final rule did disappoint physician groups in one key way. CMS rebuffed requests to have CMS require Advantage plans to use reviewers of the same specialty as treating physicians in handling disputes about prior authorization. CMS said it expects plans to exercise judgment in finding reviewers with “sufficient expertise to make an informed and supportable decision.”

“In some instances, we expect that plans will use a physician or other health care professional of the same specialty or subspecialty as the treating physician,” CMS said. “In other instances, we expect that plans will utilize a reviewer with specialized training, certification, or clinical experience in the applicable field of medicine.”
 

Medicare Advantage marketing ‘sowing confusion’

With this final rule, CMS also sought to protect consumers from “potentially misleading marketing practices” used in promoting Medicare Advantage and Part D prescription drug plans.

The agency said it had received complaints about people who have received official-looking promotional materials for Medicare that directed them not to government sources of information but to Medicare Advantage and Part D plans or their agents and brokers.

Ads now must mention a specific plan name, and they cannot use the Medicare name, CMS logo, Medicare card, or other government information in a misleading way, CMS said.

“CMS can see no value or purpose in a non-governmental entity’s use of the Medicare logo or HHS logo except for the express purpose of sowing confusion and misrepresenting itself as the government,” the agency said.

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

A new federal rule seeks to reduce Medicare Advantage insurance plans’ prior authorization burdens on physicians while also ensuring that enrollees have the same access to necessary care that they would receive under traditional fee-for-service Medicare.

The prior authorization changes, announced this week, are part of the Centers for Medicare & Medicaid Services’ 2024 update of policy changes for Medicare Advantage and Part D pharmacy plans

Medicare Advantage plans’ business practices have raised significant concerns in recent years. More than 28 million Americans were enrolled in a Medicare Advantage plan in 2022, which is nearly half of all Medicare enrollees, according to the Kaiser Family Foundation.

Medicare pays a fixed amount per enrollee per year to these privately run managed care plans, in contrast to traditional fee-for-service Medicare. Medicare Advantage plans have been criticized for aggressive marketing, for overbilling the federal government for care, and for using prior authorization to inappropriately deny needed care to patients.

About 13% of prior authorization requests that are denied by Medicare Advantage plans actually met Medicare coverage rules and should have been approved, the Office of the Inspector General at the U.S. Department of Health & Human Services reported in 2022.

The newly finalized rule now requires Medicare Advantage plans to do the following.

  • Ensure that a prior authorization approval, once granted, remains valid for as long as medically necessary to avoid disruptions in care.
  • Conduct an annual review of utilization management policies.
  • Ensure that coverage denials based on medical necessity be reviewed by health care professionals with relevant expertise before a denial can be issued.

Physician groups welcomed the changes. In a statement, the American Medical Association said that an initial reading of the rule suggested CMS had “taken important steps toward right-sizing the prior authorization process.”

The Medical Group Management Association praised CMS in a statement for having limited “dangerous disruptions and delays to necessary patient care” resulting from the cumbersome processes of prior approval. With the new rules, CMS will provide greater consistency across Advantage plans as well as traditional Medicare, said Anders Gilberg, MGMA’s senior vice president of government affairs, in a statement.
 

Peer consideration

The final rule did disappoint physician groups in one key way. CMS rebuffed requests to have CMS require Advantage plans to use reviewers of the same specialty as treating physicians in handling disputes about prior authorization. CMS said it expects plans to exercise judgment in finding reviewers with “sufficient expertise to make an informed and supportable decision.”

“In some instances, we expect that plans will use a physician or other health care professional of the same specialty or subspecialty as the treating physician,” CMS said. “In other instances, we expect that plans will utilize a reviewer with specialized training, certification, or clinical experience in the applicable field of medicine.”
 

Medicare Advantage marketing ‘sowing confusion’

With this final rule, CMS also sought to protect consumers from “potentially misleading marketing practices” used in promoting Medicare Advantage and Part D prescription drug plans.

The agency said it had received complaints about people who have received official-looking promotional materials for Medicare that directed them not to government sources of information but to Medicare Advantage and Part D plans or their agents and brokers.

Ads now must mention a specific plan name, and they cannot use the Medicare name, CMS logo, Medicare card, or other government information in a misleading way, CMS said.

“CMS can see no value or purpose in a non-governmental entity’s use of the Medicare logo or HHS logo except for the express purpose of sowing confusion and misrepresenting itself as the government,” the agency said.

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

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Picking up the premotor symptoms of Parkinson’s

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Thu, 04/06/2023 - 15:36

 

This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome back to The Curbsiders. We had a great discussion on Parkinson’s Disease for Primary Care with Dr. Albert Hung. Paul, this was something that really made me nervous. I didn’t have a lot of comfort with it. But he taught us a lot of tips about how to recognize Parkinson’s.

I hadn’t been as aware of the premotor symptoms: constipation, hyposmia (loss of sense of smell), and rapid eye movement sleep behavior disorder. If patients have those early on and they aren’t explained by other things (especially the REM sleep behavior disorder), you should really key in because those patients are at risk of developing Parkinson’s years down the line. Those symptoms could present first, which just kind of blew my mind.

What tips do you have about how to recognize Parkinson’s? Do you want to talk about the physical exam?

Paul N. Williams, MD: You know I love the physical exam stuff, so I’m happy to talk about that.



You were deeply upset that cogwheel rigidity was not pathognomonic for Parkinson’s, but you made the point – and our guest agreed – that asymmetry tends to be the key here. And I really appreciated the point about reemergent tremor. This is this idea of a resting tremor. If someone has more parkinsonian features, you might see an intention tremor with essential tremor. If they reach out, it might seem steady at first, but if they hold long enough, then the tremor may kind of reemerge. I thought that was a neat distinction.

And this idea of cogwheel rigidity is a combination of some of the cardinal features of Parkinson’s – it’s a little bit of tremor and a little bit of rigidity too. There’s a baseline increase in tone, and then the tremor is superimposed on top of that. When you’re feeling cogwheeling, that’s actually what you’re feeling on examination. Parkinson’s, with all of its physical exam findings has always fascinated me.

Dr. Watto: He also told us about some red flags.



With classic idiopathic parkinsonism, there’s asymmetric involvement of the tremor. So red flags include a symmetric tremor, which might be something other than idiopathic parkinsonism. He also mentioned that one of the reasons you may want to get imaging (which is not always necessary if someone has a classic presentation), is if you see lower body–predominant symptoms of parkinsonism. These patients have rigidity or slowness of movement in their legs, but their upper bodies are not affected. They don’t have masked facies or the tremor in their hands. You might get an MRI in that case because that could be presentation of vascular dementia or vascular disease in the brain or even normal pressure hydrocephalus, which is a treatable condition. That would be one reason to get imaging.

What if the patient was exposed to a drug like a dopamine antagonist? They will get better in a couple of days, right?

 

 

Dr. Williams: This was a really fascinating point because we typically think if a patient’s symptoms are related to a drug exposure – in this case, drug-induced parkinsonism – we can just stop the medication and the symptoms will disappear in a couple of days as the drug leaves the system. But as it turns out, it might take much longer. A mistake that Dr Hung often sees is that the clinician stops the possibly offending agent, but when they don’t see an immediate relief of symptoms, they assume the drug wasn’t causing them. You really have to give the patient a fair shot off the medication to experience recovery because those symptoms can last weeks or even months after the drug is discontinued.

Dr. Watto: Dr Hung looks at the patient’s problem list and asks whether is there any reason this patient might have been exposed to one of these medications?

We’re not going to get too much into specific Parkinson’s treatment, but I was glad to hear that exercise actually improves mobility and may even have some neuroprotective effects. He mentioned ongoing trials looking at that. We always love an excuse to tell patients that they should be moving around more and being physically active.

Dr. Williams: That was one of the more shocking things I learned, that exercise might actually be good for you. That will deeply inform my practice. Many of the treatments that we use for Parkinson’s only address symptoms. They don’t address progression or fix anything, but exercise can help with that.

Dr. Watto: Paul, the last question I wanted to ask you is about our role in primary care. Patients with Parkinson’s have autonomic symptoms. They have neurocognitive symptoms. What is our role in that as primary care physicians?

Dr. Williams: Myriad symptoms can accompany Parkinson’s, and we have experience with most of them. We should all feel fairly comfortable dealing with constipation, which can be a very bothersome symptom. And we can use our full arsenal for symptoms such as depression, anxiety, and even apathy – the anhedonia, which apparently can be the predominant feature. We do have the tools to address these problems.

This might be a situation where we might reach for bupropion or a tricyclic antidepressant, which might not be your initial choice for a patient with a possibly annoying mood disorder. But for someone with Parkinson’s disease, this actually may be very helpful. We know how to manage a lot of the symptoms that come along with Parkinson’s that are not just the motor symptoms, and we should take ownership of those things.

Dr. Watto: You can hear the rest of this podcast here. This has been another episode of The Curbsiders bringing you a little knowledge food for your brain hole. Until next time, I’ve been Dr Matthew Frank Watto.

Dr. Williams: And I’m Dr Paul Nelson Williams.

Dr. Watto is a clinical assistant professor, department of medicine, at the University of Pennsylvania, Philadelphia. Dr. Williams is Associate Professor of Clinical Medicine, Department of General Internal Medicine, at Temple University, Philadelphia. Neither Dr. Watto nor Dr. Williams reported any relevant conflicts of interest.

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

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This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome back to The Curbsiders. We had a great discussion on Parkinson’s Disease for Primary Care with Dr. Albert Hung. Paul, this was something that really made me nervous. I didn’t have a lot of comfort with it. But he taught us a lot of tips about how to recognize Parkinson’s.

I hadn’t been as aware of the premotor symptoms: constipation, hyposmia (loss of sense of smell), and rapid eye movement sleep behavior disorder. If patients have those early on and they aren’t explained by other things (especially the REM sleep behavior disorder), you should really key in because those patients are at risk of developing Parkinson’s years down the line. Those symptoms could present first, which just kind of blew my mind.

What tips do you have about how to recognize Parkinson’s? Do you want to talk about the physical exam?

Paul N. Williams, MD: You know I love the physical exam stuff, so I’m happy to talk about that.



You were deeply upset that cogwheel rigidity was not pathognomonic for Parkinson’s, but you made the point – and our guest agreed – that asymmetry tends to be the key here. And I really appreciated the point about reemergent tremor. This is this idea of a resting tremor. If someone has more parkinsonian features, you might see an intention tremor with essential tremor. If they reach out, it might seem steady at first, but if they hold long enough, then the tremor may kind of reemerge. I thought that was a neat distinction.

And this idea of cogwheel rigidity is a combination of some of the cardinal features of Parkinson’s – it’s a little bit of tremor and a little bit of rigidity too. There’s a baseline increase in tone, and then the tremor is superimposed on top of that. When you’re feeling cogwheeling, that’s actually what you’re feeling on examination. Parkinson’s, with all of its physical exam findings has always fascinated me.

Dr. Watto: He also told us about some red flags.



With classic idiopathic parkinsonism, there’s asymmetric involvement of the tremor. So red flags include a symmetric tremor, which might be something other than idiopathic parkinsonism. He also mentioned that one of the reasons you may want to get imaging (which is not always necessary if someone has a classic presentation), is if you see lower body–predominant symptoms of parkinsonism. These patients have rigidity or slowness of movement in their legs, but their upper bodies are not affected. They don’t have masked facies or the tremor in their hands. You might get an MRI in that case because that could be presentation of vascular dementia or vascular disease in the brain or even normal pressure hydrocephalus, which is a treatable condition. That would be one reason to get imaging.

What if the patient was exposed to a drug like a dopamine antagonist? They will get better in a couple of days, right?

 

 

Dr. Williams: This was a really fascinating point because we typically think if a patient’s symptoms are related to a drug exposure – in this case, drug-induced parkinsonism – we can just stop the medication and the symptoms will disappear in a couple of days as the drug leaves the system. But as it turns out, it might take much longer. A mistake that Dr Hung often sees is that the clinician stops the possibly offending agent, but when they don’t see an immediate relief of symptoms, they assume the drug wasn’t causing them. You really have to give the patient a fair shot off the medication to experience recovery because those symptoms can last weeks or even months after the drug is discontinued.

Dr. Watto: Dr Hung looks at the patient’s problem list and asks whether is there any reason this patient might have been exposed to one of these medications?

We’re not going to get too much into specific Parkinson’s treatment, but I was glad to hear that exercise actually improves mobility and may even have some neuroprotective effects. He mentioned ongoing trials looking at that. We always love an excuse to tell patients that they should be moving around more and being physically active.

Dr. Williams: That was one of the more shocking things I learned, that exercise might actually be good for you. That will deeply inform my practice. Many of the treatments that we use for Parkinson’s only address symptoms. They don’t address progression or fix anything, but exercise can help with that.

Dr. Watto: Paul, the last question I wanted to ask you is about our role in primary care. Patients with Parkinson’s have autonomic symptoms. They have neurocognitive symptoms. What is our role in that as primary care physicians?

Dr. Williams: Myriad symptoms can accompany Parkinson’s, and we have experience with most of them. We should all feel fairly comfortable dealing with constipation, which can be a very bothersome symptom. And we can use our full arsenal for symptoms such as depression, anxiety, and even apathy – the anhedonia, which apparently can be the predominant feature. We do have the tools to address these problems.

This might be a situation where we might reach for bupropion or a tricyclic antidepressant, which might not be your initial choice for a patient with a possibly annoying mood disorder. But for someone with Parkinson’s disease, this actually may be very helpful. We know how to manage a lot of the symptoms that come along with Parkinson’s that are not just the motor symptoms, and we should take ownership of those things.

Dr. Watto: You can hear the rest of this podcast here. This has been another episode of The Curbsiders bringing you a little knowledge food for your brain hole. Until next time, I’ve been Dr Matthew Frank Watto.

Dr. Williams: And I’m Dr Paul Nelson Williams.

Dr. Watto is a clinical assistant professor, department of medicine, at the University of Pennsylvania, Philadelphia. Dr. Williams is Associate Professor of Clinical Medicine, Department of General Internal Medicine, at Temple University, Philadelphia. Neither Dr. Watto nor Dr. Williams reported any relevant conflicts of interest.

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

 

This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome back to The Curbsiders. We had a great discussion on Parkinson’s Disease for Primary Care with Dr. Albert Hung. Paul, this was something that really made me nervous. I didn’t have a lot of comfort with it. But he taught us a lot of tips about how to recognize Parkinson’s.

I hadn’t been as aware of the premotor symptoms: constipation, hyposmia (loss of sense of smell), and rapid eye movement sleep behavior disorder. If patients have those early on and they aren’t explained by other things (especially the REM sleep behavior disorder), you should really key in because those patients are at risk of developing Parkinson’s years down the line. Those symptoms could present first, which just kind of blew my mind.

What tips do you have about how to recognize Parkinson’s? Do you want to talk about the physical exam?

Paul N. Williams, MD: You know I love the physical exam stuff, so I’m happy to talk about that.



You were deeply upset that cogwheel rigidity was not pathognomonic for Parkinson’s, but you made the point – and our guest agreed – that asymmetry tends to be the key here. And I really appreciated the point about reemergent tremor. This is this idea of a resting tremor. If someone has more parkinsonian features, you might see an intention tremor with essential tremor. If they reach out, it might seem steady at first, but if they hold long enough, then the tremor may kind of reemerge. I thought that was a neat distinction.

And this idea of cogwheel rigidity is a combination of some of the cardinal features of Parkinson’s – it’s a little bit of tremor and a little bit of rigidity too. There’s a baseline increase in tone, and then the tremor is superimposed on top of that. When you’re feeling cogwheeling, that’s actually what you’re feeling on examination. Parkinson’s, with all of its physical exam findings has always fascinated me.

Dr. Watto: He also told us about some red flags.



With classic idiopathic parkinsonism, there’s asymmetric involvement of the tremor. So red flags include a symmetric tremor, which might be something other than idiopathic parkinsonism. He also mentioned that one of the reasons you may want to get imaging (which is not always necessary if someone has a classic presentation), is if you see lower body–predominant symptoms of parkinsonism. These patients have rigidity or slowness of movement in their legs, but their upper bodies are not affected. They don’t have masked facies or the tremor in their hands. You might get an MRI in that case because that could be presentation of vascular dementia or vascular disease in the brain or even normal pressure hydrocephalus, which is a treatable condition. That would be one reason to get imaging.

What if the patient was exposed to a drug like a dopamine antagonist? They will get better in a couple of days, right?

 

 

Dr. Williams: This was a really fascinating point because we typically think if a patient’s symptoms are related to a drug exposure – in this case, drug-induced parkinsonism – we can just stop the medication and the symptoms will disappear in a couple of days as the drug leaves the system. But as it turns out, it might take much longer. A mistake that Dr Hung often sees is that the clinician stops the possibly offending agent, but when they don’t see an immediate relief of symptoms, they assume the drug wasn’t causing them. You really have to give the patient a fair shot off the medication to experience recovery because those symptoms can last weeks or even months after the drug is discontinued.

Dr. Watto: Dr Hung looks at the patient’s problem list and asks whether is there any reason this patient might have been exposed to one of these medications?

We’re not going to get too much into specific Parkinson’s treatment, but I was glad to hear that exercise actually improves mobility and may even have some neuroprotective effects. He mentioned ongoing trials looking at that. We always love an excuse to tell patients that they should be moving around more and being physically active.

Dr. Williams: That was one of the more shocking things I learned, that exercise might actually be good for you. That will deeply inform my practice. Many of the treatments that we use for Parkinson’s only address symptoms. They don’t address progression or fix anything, but exercise can help with that.

Dr. Watto: Paul, the last question I wanted to ask you is about our role in primary care. Patients with Parkinson’s have autonomic symptoms. They have neurocognitive symptoms. What is our role in that as primary care physicians?

Dr. Williams: Myriad symptoms can accompany Parkinson’s, and we have experience with most of them. We should all feel fairly comfortable dealing with constipation, which can be a very bothersome symptom. And we can use our full arsenal for symptoms such as depression, anxiety, and even apathy – the anhedonia, which apparently can be the predominant feature. We do have the tools to address these problems.

This might be a situation where we might reach for bupropion or a tricyclic antidepressant, which might not be your initial choice for a patient with a possibly annoying mood disorder. But for someone with Parkinson’s disease, this actually may be very helpful. We know how to manage a lot of the symptoms that come along with Parkinson’s that are not just the motor symptoms, and we should take ownership of those things.

Dr. Watto: You can hear the rest of this podcast here. This has been another episode of The Curbsiders bringing you a little knowledge food for your brain hole. Until next time, I’ve been Dr Matthew Frank Watto.

Dr. Williams: And I’m Dr Paul Nelson Williams.

Dr. Watto is a clinical assistant professor, department of medicine, at the University of Pennsylvania, Philadelphia. Dr. Williams is Associate Professor of Clinical Medicine, Department of General Internal Medicine, at Temple University, Philadelphia. Neither Dr. Watto nor Dr. Williams reported any relevant conflicts of interest.

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

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Parkinson’s disease: What’s trauma got to do with it?

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Wed, 04/05/2023 - 10:08

 

This transcript has been edited for clarity.

Kathrin LaFaver, MD: Hello. I’m happy to talk today to Dr. Indu Subramanian, clinical professor at University of California, Los Angeles, and director of the Parkinson’s Disease Research, Education and Clinical Center in Los Angeles. I am a neurologist in Saratoga Springs, New York, and we will be talking today about Indu’s new paper on childhood trauma and Parkinson’s disease. Welcome and thanks for taking the time.

Indu Subramanian, MD: Thank you so much for letting us highlight this important topic.

Dr. LaFaver: There are many papers published every month on Parkinson’s disease, but this topic stands out because it’s not a thing that has been commonly looked at. What gave you the idea to study this?
 

Neurology behind other specialties

Dr. Subramanian: Kathrin, you and I have been looking at things that can inform us about our patients – the person who’s standing in front of us when they come in and we’re giving them this diagnosis. I think that so much of what we’ve done [in the past] is a cookie cutter approach to giving everybody the standard treatment. [We’ve been assuming that] It doesn’t matter if they’re a man or woman. It doesn’t matter if they’re a veteran. It doesn’t matter if they may be from a minoritized population.

Customization is so key, and we’re realizing that we have missed the boat often through the pandemic and in health care in general.

We’ve also been interested in approaches that are outside the box, right? We have this integrative medicine and lifestyle medicine background. I’ve been going to those meetings and really been struck by the mounting evidence on the importance of things like early adverse childhood events (ACEs), what zip code you live in, what your pollution index is, and how these things can affect people through their life and their health.

I think that it is high time neurologists pay attention to this. There’s been mounting evidence throughout many disease states, various types of cancers, and mental health. Cardiology is much more advanced, but we haven’t had much data in neurology. In fact, when we went to write this paper, there were just one or two papers that were looking at multiple sclerosis or general neurologic issues, but really nothing in Parkinson’s disease.

We know that Parkinson’s disease is not only a motor disease that affects mental health, but that it also affects nonmotor issues. Childhood adversity may affect how people progress or how quickly they may get a disease, and we were interested in how it may manifest in a disease like Parkinson’s disease.

That was the framework going to meetings. As we wrote this paper and were in various editing stages, there was a beautiful paper that came out by Nadine Burke Harris and team that really was a call to action for neurologists and caring about trauma.

Dr. LaFaver: I couldn’t agree more. It’s really an underrecognized issue. With my own background, being very interested in functional movement disorders, psychosomatic disorders, and so on, it becomes much more evident how common a trauma background is, not only for people we were traditionally asking about.

Why don’t you summarize your findings for us?
 

 

 

Adverse childhood events

Dr. Subramanian: This is a web-based survey, so obviously, these are patient self-reports of their disease. We have a large cohort of people that we’ve been following over 7 years. I’m looking at modifiable variables and what really impacts Parkinson’s disease. Some of our previous papers have looked at diet, exercise, and loneliness. This is the same cohort.

We ended up putting the ACEs questionnaire, which is 10 questions looking at whether you were exposed to certain things in your household below the age of 18. This is a relatively standard questionnaire that’s administered one time, and you get a score out of 10. This is something that has been pushed, at least in the state of California, as something that we should be checking more in all people coming in.

We introduced the survey, and we didn’t force everyone to take it. Unfortunately, there was 20% or so of our patients who chose not to answer these questions. One has to ask, who are those people that didn’t answer the questions? Are they the ones that may have had trauma and these questions were triggering? It was a gap. We didn’t add extra questions to explore why people didn’t answer those questions.

We have to also put this in context. We have a patient population that’s largely quite affluent, who are able to access web-based surveys through their computer, and largely Caucasian; there are not many minoritized populations in our cohort. We want to do better with that. We actually were able to gather a decent number of women. We represent women quite well in our survey. I think that’s because of this online approach and some of the things that we’re studying.

In our survey, we broke it down into people who had no ACEs, one to three ACEs, or four or more ACEs. This is a standard way to break down ACEs so that we’re able to categorize what to do with these patient populations.

What we saw – and it’s preliminary evidence – is that people who had higher ACE scores seemed to have more symptom severity when we controlled for things like years since diagnosis, age, and gender. They also seem to have a worse quality of life. There was some indication that there were more nonmotor issues in those populations, as you might expect, such as anxiety, depression, and things that presumably ACEs can affect separately.

There are some confounders, but I think we really want to use this as the first piece of evidence to hopefully pave the way for caring about trauma in Parkinson’s disease moving forward.

Dr. LaFaver: Thank you so much for that summary. You already mentioned the main methodology you used.

What is the next step for you? How do you see these findings informing our clinical care? Do you have suggestions for all of the neurologists listening in this regard?


 

PD not yet considered ACE-related

Dr. Subramanian: Dr. Burke Harris was the former surgeon general in California. She’s a woman of color and a brilliant speaker, and she had worked in inner cities, I think in San Francisco, with pediatric populations, seeing these effects of adversity in that time frame.

 

 

You see this population at risk, and then you’re following this cohort, which we knew from the Kaiser cohort determines earlier morbidity and mortality across a number of disease states. We’re seeing things like more heart attacks, more diabetes, and all kinds of things in these populations. This is not new news; we just have not been focusing on this.

In her paper, this call to action, they had talked about some ACE-related conditions that currently do not include Parkinson’s disease. There are three ACE-related neurologic conditions that people should be aware of. One is in the headache/pain universe. Another is in the stroke universe, and that’s understandable, given cardiovascular risk factors . Then the third is in this dementia risk category. I think Parkinson’s disease, as we know, can be associated with dementia. A large percentage of our patients get dementia, but we don’t have Parkinson’s disease called out in this framework.

What people are talking about is if you have no ACEs or are in this middle category of one to three ACEs and you don’t have an ACE-related diagnosis – which Parkinson’s disease is not currently – we just give some basic counseling about the importance of lifestyle. I think we would love to see that anyway. They’re talking about things like exercise, diet, sleep, social connection, getting out in nature, things like that, so just general counseling on the importance of that.

Then if you’re in this higher-risk category, and so with these ACE-related neurologic conditions, including dementia, headache, and stroke, if you had this middle range of one to three ACEs, they’re getting additional resources. Some of them may be referred for social work help or mental health support and things like that.

I’d really love to see that happening in Parkinson’s disease, because I think we have so many needs in our population. I’m always hoping to advocate for more mental health needs that are scarce and resources in the social support realm because I believe that social connection and social support is a huge buffer for this trauma.

ACEs are just one type of trauma. I take care of veterans in the Veterans [Affairs Department]. We have some information now coming out about posttraumatic stress disorder, predisposing to certain things in Parkinson’s disease, possibly head injury, and things like that. I think we have populations at risk that we can hopefully screen at intake, and I’m really pushing for that.

Maybe it’s not the neurologist that does this intake. It might be someone else on the team that can spend some time doing these questionnaires and understand if your patient has a high ACE score. Unless you ask, many patients don’t necessarily come forward to talk about this. I really am pushing for trying to screen and trying to advocate for more research in this area so that we can classify Parkinson’s disease as an ACE-related condition and thus give more resources from the mental health world, and also the social support world, to our patients.

Dr. LaFaver: Thank you. There are many important points, and I think it’s a very important thing to recognize that it may not be only trauma in childhood but also throughout life, as you said, and might really influence nonmotor symptoms of Parkinson’s disease in particular, including anxiety and pain, which are often difficult to treat.

I think there’s much more to do in research, advocacy, and education. We’re going to educate patients about this, and also educate other neurologists and providers. I think you mentioned that trauma-informed care is getting its spotlight in primary care and other specialties. I think we have catching up to do in neurology, and I think this is a really important work toward that goal.

Thank you so much for your work and for taking the time to share your thoughts. I hope to talk to you again soon.

Dr. Subramanian: Thank you so much, Kathrin.
 

Dr. LaFaver has disclosed no relevant financial relationships. Dr. Subramanian disclosed ties with Acorda Therapeutics.

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

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This transcript has been edited for clarity.

Kathrin LaFaver, MD: Hello. I’m happy to talk today to Dr. Indu Subramanian, clinical professor at University of California, Los Angeles, and director of the Parkinson’s Disease Research, Education and Clinical Center in Los Angeles. I am a neurologist in Saratoga Springs, New York, and we will be talking today about Indu’s new paper on childhood trauma and Parkinson’s disease. Welcome and thanks for taking the time.

Indu Subramanian, MD: Thank you so much for letting us highlight this important topic.

Dr. LaFaver: There are many papers published every month on Parkinson’s disease, but this topic stands out because it’s not a thing that has been commonly looked at. What gave you the idea to study this?
 

Neurology behind other specialties

Dr. Subramanian: Kathrin, you and I have been looking at things that can inform us about our patients – the person who’s standing in front of us when they come in and we’re giving them this diagnosis. I think that so much of what we’ve done [in the past] is a cookie cutter approach to giving everybody the standard treatment. [We’ve been assuming that] It doesn’t matter if they’re a man or woman. It doesn’t matter if they’re a veteran. It doesn’t matter if they may be from a minoritized population.

Customization is so key, and we’re realizing that we have missed the boat often through the pandemic and in health care in general.

We’ve also been interested in approaches that are outside the box, right? We have this integrative medicine and lifestyle medicine background. I’ve been going to those meetings and really been struck by the mounting evidence on the importance of things like early adverse childhood events (ACEs), what zip code you live in, what your pollution index is, and how these things can affect people through their life and their health.

I think that it is high time neurologists pay attention to this. There’s been mounting evidence throughout many disease states, various types of cancers, and mental health. Cardiology is much more advanced, but we haven’t had much data in neurology. In fact, when we went to write this paper, there were just one or two papers that were looking at multiple sclerosis or general neurologic issues, but really nothing in Parkinson’s disease.

We know that Parkinson’s disease is not only a motor disease that affects mental health, but that it also affects nonmotor issues. Childhood adversity may affect how people progress or how quickly they may get a disease, and we were interested in how it may manifest in a disease like Parkinson’s disease.

That was the framework going to meetings. As we wrote this paper and were in various editing stages, there was a beautiful paper that came out by Nadine Burke Harris and team that really was a call to action for neurologists and caring about trauma.

Dr. LaFaver: I couldn’t agree more. It’s really an underrecognized issue. With my own background, being very interested in functional movement disorders, psychosomatic disorders, and so on, it becomes much more evident how common a trauma background is, not only for people we were traditionally asking about.

Why don’t you summarize your findings for us?
 

 

 

Adverse childhood events

Dr. Subramanian: This is a web-based survey, so obviously, these are patient self-reports of their disease. We have a large cohort of people that we’ve been following over 7 years. I’m looking at modifiable variables and what really impacts Parkinson’s disease. Some of our previous papers have looked at diet, exercise, and loneliness. This is the same cohort.

We ended up putting the ACEs questionnaire, which is 10 questions looking at whether you were exposed to certain things in your household below the age of 18. This is a relatively standard questionnaire that’s administered one time, and you get a score out of 10. This is something that has been pushed, at least in the state of California, as something that we should be checking more in all people coming in.

We introduced the survey, and we didn’t force everyone to take it. Unfortunately, there was 20% or so of our patients who chose not to answer these questions. One has to ask, who are those people that didn’t answer the questions? Are they the ones that may have had trauma and these questions were triggering? It was a gap. We didn’t add extra questions to explore why people didn’t answer those questions.

We have to also put this in context. We have a patient population that’s largely quite affluent, who are able to access web-based surveys through their computer, and largely Caucasian; there are not many minoritized populations in our cohort. We want to do better with that. We actually were able to gather a decent number of women. We represent women quite well in our survey. I think that’s because of this online approach and some of the things that we’re studying.

In our survey, we broke it down into people who had no ACEs, one to three ACEs, or four or more ACEs. This is a standard way to break down ACEs so that we’re able to categorize what to do with these patient populations.

What we saw – and it’s preliminary evidence – is that people who had higher ACE scores seemed to have more symptom severity when we controlled for things like years since diagnosis, age, and gender. They also seem to have a worse quality of life. There was some indication that there were more nonmotor issues in those populations, as you might expect, such as anxiety, depression, and things that presumably ACEs can affect separately.

There are some confounders, but I think we really want to use this as the first piece of evidence to hopefully pave the way for caring about trauma in Parkinson’s disease moving forward.

Dr. LaFaver: Thank you so much for that summary. You already mentioned the main methodology you used.

What is the next step for you? How do you see these findings informing our clinical care? Do you have suggestions for all of the neurologists listening in this regard?


 

PD not yet considered ACE-related

Dr. Subramanian: Dr. Burke Harris was the former surgeon general in California. She’s a woman of color and a brilliant speaker, and she had worked in inner cities, I think in San Francisco, with pediatric populations, seeing these effects of adversity in that time frame.

 

 

You see this population at risk, and then you’re following this cohort, which we knew from the Kaiser cohort determines earlier morbidity and mortality across a number of disease states. We’re seeing things like more heart attacks, more diabetes, and all kinds of things in these populations. This is not new news; we just have not been focusing on this.

In her paper, this call to action, they had talked about some ACE-related conditions that currently do not include Parkinson’s disease. There are three ACE-related neurologic conditions that people should be aware of. One is in the headache/pain universe. Another is in the stroke universe, and that’s understandable, given cardiovascular risk factors . Then the third is in this dementia risk category. I think Parkinson’s disease, as we know, can be associated with dementia. A large percentage of our patients get dementia, but we don’t have Parkinson’s disease called out in this framework.

What people are talking about is if you have no ACEs or are in this middle category of one to three ACEs and you don’t have an ACE-related diagnosis – which Parkinson’s disease is not currently – we just give some basic counseling about the importance of lifestyle. I think we would love to see that anyway. They’re talking about things like exercise, diet, sleep, social connection, getting out in nature, things like that, so just general counseling on the importance of that.

Then if you’re in this higher-risk category, and so with these ACE-related neurologic conditions, including dementia, headache, and stroke, if you had this middle range of one to three ACEs, they’re getting additional resources. Some of them may be referred for social work help or mental health support and things like that.

I’d really love to see that happening in Parkinson’s disease, because I think we have so many needs in our population. I’m always hoping to advocate for more mental health needs that are scarce and resources in the social support realm because I believe that social connection and social support is a huge buffer for this trauma.

ACEs are just one type of trauma. I take care of veterans in the Veterans [Affairs Department]. We have some information now coming out about posttraumatic stress disorder, predisposing to certain things in Parkinson’s disease, possibly head injury, and things like that. I think we have populations at risk that we can hopefully screen at intake, and I’m really pushing for that.

Maybe it’s not the neurologist that does this intake. It might be someone else on the team that can spend some time doing these questionnaires and understand if your patient has a high ACE score. Unless you ask, many patients don’t necessarily come forward to talk about this. I really am pushing for trying to screen and trying to advocate for more research in this area so that we can classify Parkinson’s disease as an ACE-related condition and thus give more resources from the mental health world, and also the social support world, to our patients.

Dr. LaFaver: Thank you. There are many important points, and I think it’s a very important thing to recognize that it may not be only trauma in childhood but also throughout life, as you said, and might really influence nonmotor symptoms of Parkinson’s disease in particular, including anxiety and pain, which are often difficult to treat.

I think there’s much more to do in research, advocacy, and education. We’re going to educate patients about this, and also educate other neurologists and providers. I think you mentioned that trauma-informed care is getting its spotlight in primary care and other specialties. I think we have catching up to do in neurology, and I think this is a really important work toward that goal.

Thank you so much for your work and for taking the time to share your thoughts. I hope to talk to you again soon.

Dr. Subramanian: Thank you so much, Kathrin.
 

Dr. LaFaver has disclosed no relevant financial relationships. Dr. Subramanian disclosed ties with Acorda Therapeutics.

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

 

This transcript has been edited for clarity.

Kathrin LaFaver, MD: Hello. I’m happy to talk today to Dr. Indu Subramanian, clinical professor at University of California, Los Angeles, and director of the Parkinson’s Disease Research, Education and Clinical Center in Los Angeles. I am a neurologist in Saratoga Springs, New York, and we will be talking today about Indu’s new paper on childhood trauma and Parkinson’s disease. Welcome and thanks for taking the time.

Indu Subramanian, MD: Thank you so much for letting us highlight this important topic.

Dr. LaFaver: There are many papers published every month on Parkinson’s disease, but this topic stands out because it’s not a thing that has been commonly looked at. What gave you the idea to study this?
 

Neurology behind other specialties

Dr. Subramanian: Kathrin, you and I have been looking at things that can inform us about our patients – the person who’s standing in front of us when they come in and we’re giving them this diagnosis. I think that so much of what we’ve done [in the past] is a cookie cutter approach to giving everybody the standard treatment. [We’ve been assuming that] It doesn’t matter if they’re a man or woman. It doesn’t matter if they’re a veteran. It doesn’t matter if they may be from a minoritized population.

Customization is so key, and we’re realizing that we have missed the boat often through the pandemic and in health care in general.

We’ve also been interested in approaches that are outside the box, right? We have this integrative medicine and lifestyle medicine background. I’ve been going to those meetings and really been struck by the mounting evidence on the importance of things like early adverse childhood events (ACEs), what zip code you live in, what your pollution index is, and how these things can affect people through their life and their health.

I think that it is high time neurologists pay attention to this. There’s been mounting evidence throughout many disease states, various types of cancers, and mental health. Cardiology is much more advanced, but we haven’t had much data in neurology. In fact, when we went to write this paper, there were just one or two papers that were looking at multiple sclerosis or general neurologic issues, but really nothing in Parkinson’s disease.

We know that Parkinson’s disease is not only a motor disease that affects mental health, but that it also affects nonmotor issues. Childhood adversity may affect how people progress or how quickly they may get a disease, and we were interested in how it may manifest in a disease like Parkinson’s disease.

That was the framework going to meetings. As we wrote this paper and were in various editing stages, there was a beautiful paper that came out by Nadine Burke Harris and team that really was a call to action for neurologists and caring about trauma.

Dr. LaFaver: I couldn’t agree more. It’s really an underrecognized issue. With my own background, being very interested in functional movement disorders, psychosomatic disorders, and so on, it becomes much more evident how common a trauma background is, not only for people we were traditionally asking about.

Why don’t you summarize your findings for us?
 

 

 

Adverse childhood events

Dr. Subramanian: This is a web-based survey, so obviously, these are patient self-reports of their disease. We have a large cohort of people that we’ve been following over 7 years. I’m looking at modifiable variables and what really impacts Parkinson’s disease. Some of our previous papers have looked at diet, exercise, and loneliness. This is the same cohort.

We ended up putting the ACEs questionnaire, which is 10 questions looking at whether you were exposed to certain things in your household below the age of 18. This is a relatively standard questionnaire that’s administered one time, and you get a score out of 10. This is something that has been pushed, at least in the state of California, as something that we should be checking more in all people coming in.

We introduced the survey, and we didn’t force everyone to take it. Unfortunately, there was 20% or so of our patients who chose not to answer these questions. One has to ask, who are those people that didn’t answer the questions? Are they the ones that may have had trauma and these questions were triggering? It was a gap. We didn’t add extra questions to explore why people didn’t answer those questions.

We have to also put this in context. We have a patient population that’s largely quite affluent, who are able to access web-based surveys through their computer, and largely Caucasian; there are not many minoritized populations in our cohort. We want to do better with that. We actually were able to gather a decent number of women. We represent women quite well in our survey. I think that’s because of this online approach and some of the things that we’re studying.

In our survey, we broke it down into people who had no ACEs, one to three ACEs, or four or more ACEs. This is a standard way to break down ACEs so that we’re able to categorize what to do with these patient populations.

What we saw – and it’s preliminary evidence – is that people who had higher ACE scores seemed to have more symptom severity when we controlled for things like years since diagnosis, age, and gender. They also seem to have a worse quality of life. There was some indication that there were more nonmotor issues in those populations, as you might expect, such as anxiety, depression, and things that presumably ACEs can affect separately.

There are some confounders, but I think we really want to use this as the first piece of evidence to hopefully pave the way for caring about trauma in Parkinson’s disease moving forward.

Dr. LaFaver: Thank you so much for that summary. You already mentioned the main methodology you used.

What is the next step for you? How do you see these findings informing our clinical care? Do you have suggestions for all of the neurologists listening in this regard?


 

PD not yet considered ACE-related

Dr. Subramanian: Dr. Burke Harris was the former surgeon general in California. She’s a woman of color and a brilliant speaker, and she had worked in inner cities, I think in San Francisco, with pediatric populations, seeing these effects of adversity in that time frame.

 

 

You see this population at risk, and then you’re following this cohort, which we knew from the Kaiser cohort determines earlier morbidity and mortality across a number of disease states. We’re seeing things like more heart attacks, more diabetes, and all kinds of things in these populations. This is not new news; we just have not been focusing on this.

In her paper, this call to action, they had talked about some ACE-related conditions that currently do not include Parkinson’s disease. There are three ACE-related neurologic conditions that people should be aware of. One is in the headache/pain universe. Another is in the stroke universe, and that’s understandable, given cardiovascular risk factors . Then the third is in this dementia risk category. I think Parkinson’s disease, as we know, can be associated with dementia. A large percentage of our patients get dementia, but we don’t have Parkinson’s disease called out in this framework.

What people are talking about is if you have no ACEs or are in this middle category of one to three ACEs and you don’t have an ACE-related diagnosis – which Parkinson’s disease is not currently – we just give some basic counseling about the importance of lifestyle. I think we would love to see that anyway. They’re talking about things like exercise, diet, sleep, social connection, getting out in nature, things like that, so just general counseling on the importance of that.

Then if you’re in this higher-risk category, and so with these ACE-related neurologic conditions, including dementia, headache, and stroke, if you had this middle range of one to three ACEs, they’re getting additional resources. Some of them may be referred for social work help or mental health support and things like that.

I’d really love to see that happening in Parkinson’s disease, because I think we have so many needs in our population. I’m always hoping to advocate for more mental health needs that are scarce and resources in the social support realm because I believe that social connection and social support is a huge buffer for this trauma.

ACEs are just one type of trauma. I take care of veterans in the Veterans [Affairs Department]. We have some information now coming out about posttraumatic stress disorder, predisposing to certain things in Parkinson’s disease, possibly head injury, and things like that. I think we have populations at risk that we can hopefully screen at intake, and I’m really pushing for that.

Maybe it’s not the neurologist that does this intake. It might be someone else on the team that can spend some time doing these questionnaires and understand if your patient has a high ACE score. Unless you ask, many patients don’t necessarily come forward to talk about this. I really am pushing for trying to screen and trying to advocate for more research in this area so that we can classify Parkinson’s disease as an ACE-related condition and thus give more resources from the mental health world, and also the social support world, to our patients.

Dr. LaFaver: Thank you. There are many important points, and I think it’s a very important thing to recognize that it may not be only trauma in childhood but also throughout life, as you said, and might really influence nonmotor symptoms of Parkinson’s disease in particular, including anxiety and pain, which are often difficult to treat.

I think there’s much more to do in research, advocacy, and education. We’re going to educate patients about this, and also educate other neurologists and providers. I think you mentioned that trauma-informed care is getting its spotlight in primary care and other specialties. I think we have catching up to do in neurology, and I think this is a really important work toward that goal.

Thank you so much for your work and for taking the time to share your thoughts. I hope to talk to you again soon.

Dr. Subramanian: Thank you so much, Kathrin.
 

Dr. LaFaver has disclosed no relevant financial relationships. Dr. Subramanian disclosed ties with Acorda Therapeutics.

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

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Cervical screening often stops at 65, but should it?

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Fri, 04/07/2023 - 14:04

 

“Did you love your wife?” asks a character in “Rose,” a book by Martin Cruz Smith.

“No, but she became a fact through perseverance,” the man replied.

Medicine also has such relationships, it seems – tentative ideas that turned into fact simply by existing long enough.

Age 65 as the cutoff for cervical screening may be one such example. It has existed for 27 years with limited science to back it up. That may soon change with the launch of a $3.3 million study that is being funded by the National Institutes of Health (NIH). The study is intended to provide a more solid foundation for the benefits and harms of cervical screening for women older than 65.

It’s an important issue: 20% of all cervical cancer cases are found in women who are older than 65. Most of these patients have late-stage disease, which can be fatal. In the United States, 35% of cervical cancer deaths occur after age 65. But women in this age group are usually no longer screened for cervical cancer.

Back in 1996, the U.S. Preventive Services Task Force recommended that for women at average risk with adequate prior screening, cervical screening should stop at the age of 65. This recommendation has been carried forward year after year and has been incorporated into several other guidelines.

For example, current guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the USPSTF recommend that cervical screening stop at aged 65 for patients with adequate prior screening.

“Adequate screening” is defined as three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative co-tests within the prior 10 years, with the most recent screening within 5 years and with no precancerous lesions in the past 25 years.

This all sounds reasonable; however, for most women, medical records aren’t up to the task of providing a clean bill of cervical health over many decades.

Explained Sarah Feldman, MD, an associate professor in obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston: “You know, when a patient says to me at 65, ‘Should I continue screening?’ I say, ‘Do you have all your results?’ And they’ll say, ‘Well, I remember I had a sort of abnormal pap 15 years ago,’ and I say, ‘All right; well, who knows what that was?’ So I’ll continue screening.”

According to George Sawaya, MD, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, up to 60% of women do not meet the criteria to end screening at age 65. This means that each year in the United States, approximately 1.7 million women turn 65 and should, in theory, continue to undergo screening for cervical cancer.

Unfortunately, the evidence base for the harms and benefits of cervical screening after age 65 is almost nonexistent – at least by the current standards of evidence-based medicine.

“We need to be clear that we don’t really know the appropriateness of the screening after 65,” said Dr. Sawaya, “which is ironic, because cervical cancer screening is probably the most commonly implemented cancer screening test in the country because it starts so early and ends so late and it’s applied so frequently.”

Dr. Feldman agrees that the age 65 cutoff is “somewhat arbitrary.” She said, “Why don’t they want to consider it continuing past 65? I don’t really understand, I have to be honest with you.”

So what’s the scientific evidence backing up the 27-year-old recommendation?

In 2018, the USPSTF’s cervical-screening guidelines concluded “with moderate certainty that the benefits of screening in women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer do not outweigh the potential harms.”

This recommendation was based on a new decision model commissioned by the USPSTF. The model was needed because, as noted by the guidelines’ authors, “None of the screening trials enrolled women older than 65 years, so direct evidence on when to stop screening is not available.”

In 2020, the ACS carried out a fresh literature review and published its own recommendations. The ACS concluded that “the evidence for the effectiveness of screening beyond age 65 is limited, based solely on observational and modeling studies.”

As a result, the ACS assigned a “qualified recommendation” to the age-65 moratorium (defined as “less certainty about the balance of benefits and harms or about patients’ values and preferences”).

Most recently, the 2021 Updated Cervical Cancer Screening Guidelines, published by the American College of Obstetricians and Gynecologists, endorsed the recommendations of the USPSTF.

Dr. Sawaya said, “The whole issue about screening over 65 is complicated from a lot of perspectives. We don’t know a lot about the safety. We don’t really know a lot about patients’ perceptions of it. But we do know that there has to be an upper age limit after which screening is just simply imprudent.”

Dr. Sawaya acknowledges that there exists a “heck-why-not” attitude toward cervical screening after 65 among some physicians, given that the tests are quick and cheap and could save a life, but he sounds a note of caution.

“It’s like when we used to use old cameras: the film was cheap, but the developing was really expensive,” Dr. Sawaya said. “So it’s not necessarily about the tests being cheap, it’s about the cascade of events [that follow].”

Follow-up for cervical cancer can be more hazardous for a postmenopausal patient than for a younger woman, explained Dr. Sawaya, because the transformation zone of the cervix may be difficult to see on colposcopy. Instead of a straightforward 5-minute procedure in the doctor’s office, the older patient may need the operating room simply to provide the first biopsy.

In addition, treatments such as cone biopsy, loop excision, or ablation are also more worrying for older women, said Dr. Sawaya, “So you start thinking about the risks of anesthesia, you start thinking about the risks of bleeding and infection, etc. And these have not been well described in older people.”

To add to the uncertainty about the merits and risks of hunting out cervical cancer in older women, a lot has changed in women’s health since 1996.

Explained Dr. Sawaya, “This stake was put in the ground in 1996, ... but since that time, life expectancy has gained 5 years. So a logical person would say, ‘Oh, well, let’s just say it should be 70 now, right?’ [But] can we even use old studies to inform the current cohort of women who are entering this 65-year-and-older age group?”

To answer all these questions, a 5-year, $3.3 million study funded by the NIH through the National Cancer Institute is now underway.

The project, named Comparative Effectiveness Research to Validate and Improve Cervical Cancer Screening (CERVICCS 2), will be led by Dr. Sawaya and Michael Silverberg, PhD, associate director of the Behavioral Health, Aging and Infectious Diseases Section of Kaiser Permanente Northern California’s Division of Research.

 

 


It’s not possible to conduct a true randomized controlled trial in this field of medicine for ethical reasons, so CERVICCS 2 will emulate a randomized study by following the fate of approximately 280,000 women older than 65 who were long-term members of two large health systems during 2005-2022. The cohort-study design will allow the researchers to track cervical cancer incidence, stage at diagnosis, and cancer mortality and then compare these outcomes to a person’s screening history – both before and after the crucial age 65 cutoff.

The California study will also look at the downsides of diagnostic procedures and surgical interventions that follow a positive screening result after the age of 65 and the personal experiences of the women involved.

Dr. Sawaya and Dr. Silverberg’s team will use software that emulates a clinical trial by utilizing observational data to compare the benefits and risks of screening continuation or screening cessation after age 65.

In effect, after 27 years of loyalty to a recommendation supported by low-quality evidence, medicine will finally have a reliable answer to the question, Should we continue to look for cervical cancer in women over 65?

Dr. Sawaya concluded: “There’s very few things that are packaged away and thought to be just the truth. And this is why we always have to be vigilant. ... And that’s what keeps science so interesting and exciting.”

Dr. Sawaya has disclosed no relevant financial relationships. Dr. Feldman writes for UpToDate and receives several NIH grants.

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

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“Did you love your wife?” asks a character in “Rose,” a book by Martin Cruz Smith.

“No, but she became a fact through perseverance,” the man replied.

Medicine also has such relationships, it seems – tentative ideas that turned into fact simply by existing long enough.

Age 65 as the cutoff for cervical screening may be one such example. It has existed for 27 years with limited science to back it up. That may soon change with the launch of a $3.3 million study that is being funded by the National Institutes of Health (NIH). The study is intended to provide a more solid foundation for the benefits and harms of cervical screening for women older than 65.

It’s an important issue: 20% of all cervical cancer cases are found in women who are older than 65. Most of these patients have late-stage disease, which can be fatal. In the United States, 35% of cervical cancer deaths occur after age 65. But women in this age group are usually no longer screened for cervical cancer.

Back in 1996, the U.S. Preventive Services Task Force recommended that for women at average risk with adequate prior screening, cervical screening should stop at the age of 65. This recommendation has been carried forward year after year and has been incorporated into several other guidelines.

For example, current guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the USPSTF recommend that cervical screening stop at aged 65 for patients with adequate prior screening.

“Adequate screening” is defined as three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative co-tests within the prior 10 years, with the most recent screening within 5 years and with no precancerous lesions in the past 25 years.

This all sounds reasonable; however, for most women, medical records aren’t up to the task of providing a clean bill of cervical health over many decades.

Explained Sarah Feldman, MD, an associate professor in obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston: “You know, when a patient says to me at 65, ‘Should I continue screening?’ I say, ‘Do you have all your results?’ And they’ll say, ‘Well, I remember I had a sort of abnormal pap 15 years ago,’ and I say, ‘All right; well, who knows what that was?’ So I’ll continue screening.”

According to George Sawaya, MD, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, up to 60% of women do not meet the criteria to end screening at age 65. This means that each year in the United States, approximately 1.7 million women turn 65 and should, in theory, continue to undergo screening for cervical cancer.

Unfortunately, the evidence base for the harms and benefits of cervical screening after age 65 is almost nonexistent – at least by the current standards of evidence-based medicine.

“We need to be clear that we don’t really know the appropriateness of the screening after 65,” said Dr. Sawaya, “which is ironic, because cervical cancer screening is probably the most commonly implemented cancer screening test in the country because it starts so early and ends so late and it’s applied so frequently.”

Dr. Feldman agrees that the age 65 cutoff is “somewhat arbitrary.” She said, “Why don’t they want to consider it continuing past 65? I don’t really understand, I have to be honest with you.”

So what’s the scientific evidence backing up the 27-year-old recommendation?

In 2018, the USPSTF’s cervical-screening guidelines concluded “with moderate certainty that the benefits of screening in women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer do not outweigh the potential harms.”

This recommendation was based on a new decision model commissioned by the USPSTF. The model was needed because, as noted by the guidelines’ authors, “None of the screening trials enrolled women older than 65 years, so direct evidence on when to stop screening is not available.”

In 2020, the ACS carried out a fresh literature review and published its own recommendations. The ACS concluded that “the evidence for the effectiveness of screening beyond age 65 is limited, based solely on observational and modeling studies.”

As a result, the ACS assigned a “qualified recommendation” to the age-65 moratorium (defined as “less certainty about the balance of benefits and harms or about patients’ values and preferences”).

Most recently, the 2021 Updated Cervical Cancer Screening Guidelines, published by the American College of Obstetricians and Gynecologists, endorsed the recommendations of the USPSTF.

Dr. Sawaya said, “The whole issue about screening over 65 is complicated from a lot of perspectives. We don’t know a lot about the safety. We don’t really know a lot about patients’ perceptions of it. But we do know that there has to be an upper age limit after which screening is just simply imprudent.”

Dr. Sawaya acknowledges that there exists a “heck-why-not” attitude toward cervical screening after 65 among some physicians, given that the tests are quick and cheap and could save a life, but he sounds a note of caution.

“It’s like when we used to use old cameras: the film was cheap, but the developing was really expensive,” Dr. Sawaya said. “So it’s not necessarily about the tests being cheap, it’s about the cascade of events [that follow].”

Follow-up for cervical cancer can be more hazardous for a postmenopausal patient than for a younger woman, explained Dr. Sawaya, because the transformation zone of the cervix may be difficult to see on colposcopy. Instead of a straightforward 5-minute procedure in the doctor’s office, the older patient may need the operating room simply to provide the first biopsy.

In addition, treatments such as cone biopsy, loop excision, or ablation are also more worrying for older women, said Dr. Sawaya, “So you start thinking about the risks of anesthesia, you start thinking about the risks of bleeding and infection, etc. And these have not been well described in older people.”

To add to the uncertainty about the merits and risks of hunting out cervical cancer in older women, a lot has changed in women’s health since 1996.

Explained Dr. Sawaya, “This stake was put in the ground in 1996, ... but since that time, life expectancy has gained 5 years. So a logical person would say, ‘Oh, well, let’s just say it should be 70 now, right?’ [But] can we even use old studies to inform the current cohort of women who are entering this 65-year-and-older age group?”

To answer all these questions, a 5-year, $3.3 million study funded by the NIH through the National Cancer Institute is now underway.

The project, named Comparative Effectiveness Research to Validate and Improve Cervical Cancer Screening (CERVICCS 2), will be led by Dr. Sawaya and Michael Silverberg, PhD, associate director of the Behavioral Health, Aging and Infectious Diseases Section of Kaiser Permanente Northern California’s Division of Research.

 

 


It’s not possible to conduct a true randomized controlled trial in this field of medicine for ethical reasons, so CERVICCS 2 will emulate a randomized study by following the fate of approximately 280,000 women older than 65 who were long-term members of two large health systems during 2005-2022. The cohort-study design will allow the researchers to track cervical cancer incidence, stage at diagnosis, and cancer mortality and then compare these outcomes to a person’s screening history – both before and after the crucial age 65 cutoff.

The California study will also look at the downsides of diagnostic procedures and surgical interventions that follow a positive screening result after the age of 65 and the personal experiences of the women involved.

Dr. Sawaya and Dr. Silverberg’s team will use software that emulates a clinical trial by utilizing observational data to compare the benefits and risks of screening continuation or screening cessation after age 65.

In effect, after 27 years of loyalty to a recommendation supported by low-quality evidence, medicine will finally have a reliable answer to the question, Should we continue to look for cervical cancer in women over 65?

Dr. Sawaya concluded: “There’s very few things that are packaged away and thought to be just the truth. And this is why we always have to be vigilant. ... And that’s what keeps science so interesting and exciting.”

Dr. Sawaya has disclosed no relevant financial relationships. Dr. Feldman writes for UpToDate and receives several NIH grants.

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

 

“Did you love your wife?” asks a character in “Rose,” a book by Martin Cruz Smith.

“No, but she became a fact through perseverance,” the man replied.

Medicine also has such relationships, it seems – tentative ideas that turned into fact simply by existing long enough.

Age 65 as the cutoff for cervical screening may be one such example. It has existed for 27 years with limited science to back it up. That may soon change with the launch of a $3.3 million study that is being funded by the National Institutes of Health (NIH). The study is intended to provide a more solid foundation for the benefits and harms of cervical screening for women older than 65.

It’s an important issue: 20% of all cervical cancer cases are found in women who are older than 65. Most of these patients have late-stage disease, which can be fatal. In the United States, 35% of cervical cancer deaths occur after age 65. But women in this age group are usually no longer screened for cervical cancer.

Back in 1996, the U.S. Preventive Services Task Force recommended that for women at average risk with adequate prior screening, cervical screening should stop at the age of 65. This recommendation has been carried forward year after year and has been incorporated into several other guidelines.

For example, current guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the USPSTF recommend that cervical screening stop at aged 65 for patients with adequate prior screening.

“Adequate screening” is defined as three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative co-tests within the prior 10 years, with the most recent screening within 5 years and with no precancerous lesions in the past 25 years.

This all sounds reasonable; however, for most women, medical records aren’t up to the task of providing a clean bill of cervical health over many decades.

Explained Sarah Feldman, MD, an associate professor in obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston: “You know, when a patient says to me at 65, ‘Should I continue screening?’ I say, ‘Do you have all your results?’ And they’ll say, ‘Well, I remember I had a sort of abnormal pap 15 years ago,’ and I say, ‘All right; well, who knows what that was?’ So I’ll continue screening.”

According to George Sawaya, MD, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, up to 60% of women do not meet the criteria to end screening at age 65. This means that each year in the United States, approximately 1.7 million women turn 65 and should, in theory, continue to undergo screening for cervical cancer.

Unfortunately, the evidence base for the harms and benefits of cervical screening after age 65 is almost nonexistent – at least by the current standards of evidence-based medicine.

“We need to be clear that we don’t really know the appropriateness of the screening after 65,” said Dr. Sawaya, “which is ironic, because cervical cancer screening is probably the most commonly implemented cancer screening test in the country because it starts so early and ends so late and it’s applied so frequently.”

Dr. Feldman agrees that the age 65 cutoff is “somewhat arbitrary.” She said, “Why don’t they want to consider it continuing past 65? I don’t really understand, I have to be honest with you.”

So what’s the scientific evidence backing up the 27-year-old recommendation?

In 2018, the USPSTF’s cervical-screening guidelines concluded “with moderate certainty that the benefits of screening in women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer do not outweigh the potential harms.”

This recommendation was based on a new decision model commissioned by the USPSTF. The model was needed because, as noted by the guidelines’ authors, “None of the screening trials enrolled women older than 65 years, so direct evidence on when to stop screening is not available.”

In 2020, the ACS carried out a fresh literature review and published its own recommendations. The ACS concluded that “the evidence for the effectiveness of screening beyond age 65 is limited, based solely on observational and modeling studies.”

As a result, the ACS assigned a “qualified recommendation” to the age-65 moratorium (defined as “less certainty about the balance of benefits and harms or about patients’ values and preferences”).

Most recently, the 2021 Updated Cervical Cancer Screening Guidelines, published by the American College of Obstetricians and Gynecologists, endorsed the recommendations of the USPSTF.

Dr. Sawaya said, “The whole issue about screening over 65 is complicated from a lot of perspectives. We don’t know a lot about the safety. We don’t really know a lot about patients’ perceptions of it. But we do know that there has to be an upper age limit after which screening is just simply imprudent.”

Dr. Sawaya acknowledges that there exists a “heck-why-not” attitude toward cervical screening after 65 among some physicians, given that the tests are quick and cheap and could save a life, but he sounds a note of caution.

“It’s like when we used to use old cameras: the film was cheap, but the developing was really expensive,” Dr. Sawaya said. “So it’s not necessarily about the tests being cheap, it’s about the cascade of events [that follow].”

Follow-up for cervical cancer can be more hazardous for a postmenopausal patient than for a younger woman, explained Dr. Sawaya, because the transformation zone of the cervix may be difficult to see on colposcopy. Instead of a straightforward 5-minute procedure in the doctor’s office, the older patient may need the operating room simply to provide the first biopsy.

In addition, treatments such as cone biopsy, loop excision, or ablation are also more worrying for older women, said Dr. Sawaya, “So you start thinking about the risks of anesthesia, you start thinking about the risks of bleeding and infection, etc. And these have not been well described in older people.”

To add to the uncertainty about the merits and risks of hunting out cervical cancer in older women, a lot has changed in women’s health since 1996.

Explained Dr. Sawaya, “This stake was put in the ground in 1996, ... but since that time, life expectancy has gained 5 years. So a logical person would say, ‘Oh, well, let’s just say it should be 70 now, right?’ [But] can we even use old studies to inform the current cohort of women who are entering this 65-year-and-older age group?”

To answer all these questions, a 5-year, $3.3 million study funded by the NIH through the National Cancer Institute is now underway.

The project, named Comparative Effectiveness Research to Validate and Improve Cervical Cancer Screening (CERVICCS 2), will be led by Dr. Sawaya and Michael Silverberg, PhD, associate director of the Behavioral Health, Aging and Infectious Diseases Section of Kaiser Permanente Northern California’s Division of Research.

 

 


It’s not possible to conduct a true randomized controlled trial in this field of medicine for ethical reasons, so CERVICCS 2 will emulate a randomized study by following the fate of approximately 280,000 women older than 65 who were long-term members of two large health systems during 2005-2022. The cohort-study design will allow the researchers to track cervical cancer incidence, stage at diagnosis, and cancer mortality and then compare these outcomes to a person’s screening history – both before and after the crucial age 65 cutoff.

The California study will also look at the downsides of diagnostic procedures and surgical interventions that follow a positive screening result after the age of 65 and the personal experiences of the women involved.

Dr. Sawaya and Dr. Silverberg’s team will use software that emulates a clinical trial by utilizing observational data to compare the benefits and risks of screening continuation or screening cessation after age 65.

In effect, after 27 years of loyalty to a recommendation supported by low-quality evidence, medicine will finally have a reliable answer to the question, Should we continue to look for cervical cancer in women over 65?

Dr. Sawaya concluded: “There’s very few things that are packaged away and thought to be just the truth. And this is why we always have to be vigilant. ... And that’s what keeps science so interesting and exciting.”

Dr. Sawaya has disclosed no relevant financial relationships. Dr. Feldman writes for UpToDate and receives several NIH grants.

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

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