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Tension, Other Headache Types Robustly Linked to Attempted, Completed Suicide
DENVER –
, results of a large study suggest.The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.
The retrospective analysis included data on more than 100,000 headache patients from a Danish registry.
“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
Underestimated Problem
Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability.
Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.
However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.
Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.
Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.
Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.
Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.
Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.
For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
Robust Link
The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.
The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.
After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).
“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.
For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).
The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.
The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
Ask About Mood
The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.
After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.
Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.
A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.
Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.
Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”
It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.
The study received support from Aarhus University. No relevant conflicts of interest were reported.
A version of this article appeared on Medscape.com.
DENVER –
, results of a large study suggest.The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.
The retrospective analysis included data on more than 100,000 headache patients from a Danish registry.
“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
Underestimated Problem
Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability.
Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.
However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.
Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.
Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.
Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.
Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.
Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.
For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
Robust Link
The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.
The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.
After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).
“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.
For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).
The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.
The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
Ask About Mood
The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.
After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.
Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.
A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.
Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.
Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”
It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.
The study received support from Aarhus University. No relevant conflicts of interest were reported.
A version of this article appeared on Medscape.com.
DENVER –
, results of a large study suggest.The risk for suicide attempt was four times higher in people with trigeminal and autonomic cephalalgias (TAC), and the risk for completed suicide was double among those with posttraumatic headache compared with individuals with no headache.
The retrospective analysis included data on more than 100,000 headache patients from a Danish registry.
“The results suggest there’s a unique risk among headache patients for attempted and completed suicide,” lead investigator Holly Elser, MD, MPH, PhD, resident, Department of Neurology, University of Pennsylvania, Philadelphia, said at the 2024 annual meeting of the American Academy of Neurology, where the findings were presented. “This really underscores the potential importance of complementary psychiatric evaluation and treatment for individuals diagnosed with headache.”
Underestimated Problem
Headache disorders affect about half of working-age adults and are among the leading causes of productivity loss, absence from work, and disability.
Prior research suggests headache disorders often co-occur with psychiatric illness including depression, anxiety, posttraumatic stress disorder, and even attempted suicide.
However, previous studies that showed an increased risk for attempted suicide in patients with headache relied heavily on survey data and mostly focused on patients with migraine. There was little information on other headache types and on the risk for completed suicide.
Researchers used Danish registries to identify 64,057 patients with migraine, 40,160 with tension-type headache (TTH), 5743 with TAC, and 4253 with posttraumatic headache, all diagnosed from 1995 to 2019.
Some 5.8% of those with migraine, 6.3% with TAC, 7.2% with TTH, and 7.2% with posttraumatic headache, had a mood disorder (depression and anxiety combined) at baseline.
Those without a headache diagnosis were matched 5:1 to those with a headache diagnosis by sex and birth year.
Across all headache disorders, baseline prevalence of mood disorder was higher among those with headache versus population-matched controls. Dr. Elser emphasized that these are people diagnosed with a mood disorder in the inpatient, emergency department, or outpatient specialist clinic setting, “which means we are almost certainly underestimating the true burden of mood symptoms in our cohort,” she said.
Researchers identified attempted suicides using diagnostic codes. For completed suicide, they determined whether those who attempted suicide died within 30 days of the attempt.
For each headache type, investigators examined both the absolute and relative risk for attempted and completed suicides and estimated the risk at intervals of 5, 10, and 20 years after initial headache diagnosis.
Robust Link
The “power of this study is that we asked a simple, but important question, and answered it with simple, but appropriate, methodologic techniques,” Dr. Elser said.
The estimated risk differences (RDs) for attempted suicide were strongest for TAC and posttraumatic headache and for longer follow-ups. The RDs for completed suicide were largely the same but of a smaller magnitude and were “relatively less precise,” reflecting the “rarity of this outcome,” said Dr. Elser.
After adjusting for sex, age, education, income, comorbidities, and baseline medical and psychiatric diagnoses, researchers found the strongest association or attempted suicide was among those with TAC (adjusted hazard ratio [aHR], 4.25; 95% CI, 2.85-6.33).
“A hazard ratio of 4 is enormous” for this type of comparison, Dr. Elser noted.
For completed suicide, the strongest association was with posttraumatic headache (aHR, 2.19; 95% CI, 0.78-6.16).
The study revealed a robust association with attempted and completed suicide across all headache types, including TTH, noted Dr. Elser. The link between tension headaches and suicide “was the most striking finding to me because I think of that as sort of a benign and common headache disorder,” she said.
The was an observational study, so “it’s not clear whether headache is playing an etiological role in the relationship with suicide,” she said. “It’s possible there are common shared risk factors or confounders that explain the relationship in full or in part that aren’t accounted for in this study.”
Ask About Mood
The results underscore the need for psychiatric evaluations in patients with a headache disorder. “For me, this is just going to make me that much more likely to ask my patients about their mood when I see them in clinic,” Dr. Elser said.
After asking patients with headache about their mood and stress at home and at work, physicians should have a “low threshold to refer to a behavioral health provider,” she added.
Future research should aim to better understand the link between headache and suicide risk, with a focus on the mechanisms behind low- and high-risk subgroups, said Dr. Elser.
A limitation of the study was that headache diagnoses were based on inpatient, emergency department, and outpatient specialist visits but not on visits to primary care practitioners. The study didn’t include information on headache severity or frequency and included only people who sought treatment for their headaches.
Though it’s unlikely the results “are perfectly generalizable” with respect to other geographical or cultural contexts, “I don’t think this relationship is unique to Denmark based on the literature to date,” Dr. Elser said.
Commenting on the study, session co-chair Todd J. Schwedt, MD, professor of neurology, Mayo Clinic Arizona, Phoenix, and president-elect of the American Headache Society, noted that the study offers important findings “that demonstrate the enormous negative impact that headaches can exert.”
It’s “a strong reminder” that clinicians should assess the mental health of their patients with headaches and offer treatment when appropriate, he said.
The study received support from Aarhus University. No relevant conflicts of interest were reported.
A version of this article appeared on Medscape.com.
FROM AAN 2024
Chronic Pain Linked to Accelerated Brain Aging
, new research showed.
Using structural MRI data from more than 9000 adults with knee osteoarthritis (KOA) from the UK Biobank, investigators developed a brain age model to compare an individual’s brain age with their chronological age. Those with KOA showed a much faster rate of brain aging than healthy individuals.
The acceleration in brain aging was largely driven by the hippocampus and predicted memory decline and incident dementia during follow-up. Researchers identified a gene highly expressed in glial cells as a possible genetic factor for accelerated brain aging.
“We demonstrate the accelerated brain aging and cognitive decline in chronic musculoskeletal pain, in particular knee osteoarthritis, and provide a neural marker for early detection and intervention,” said co-first author Jiao Liu, PhD candidate, Chinese Academy of Sciences, Beijing.
“We are interested to know how to slow down the aging brain in chronic musculoskeletal pain patients. Proper exercise and lifestyle may reduce the risk,” Dr. Liu said.
The study was published online in Nature Mental Health.
Common Condition
CMP affects more than 40% of the world’s population and has been shown to have a harmful impact on cognitive function, although the exact mechanisms remain unclear. Prior research suggests that inflammatory markers associated with brain aging are higher in patients with CMP, suggesting a link between brain aging and CMP.
To investigate further, researchers explored patterns of brain aging in healthy cohorts and cohorts with four common types of CMP — chronic knee pain, chronic back pain, chronic neck pain, and chronic hip pain.
Using their brain age model, investigators observed significantly increased brain aging, or “predicted age difference,” only in individuals with KOA (P < .001). The observation was validated in an independent dataset (P = .020), suggesting a pattern of brain aging acceleration specific to KOA.
This acceleration was primarily driven by key brain regions involved in cognitive processing, including hippocampus and orbitofrontal cortex, and was correlated with longitudinal memory decline and dementia risk.
These data also suggest that the SLC39A8 gene, which is highly expressed in glial cells, might be a key genetic factor underpinning this acceleration.
“We not only revealed the specificity of accelerated brain aging in knee osteoarthritis patients, but importantly, we also provided longitudinal evidence suggesting the ability of our brain aging marker to predict future memory decline and increased dementia risk,” corresponding author Yiheng Tu, PhD, also with Chinese Academy of Sciences, Beijing, said in a news release.
A Future Treatment Target?
Commenting on this research, Shaheen Lakhan, MD, PhD, a neurologist and researcher based in Miami, noted that in this study, people with KOA showed signs of “faster brain aging on scans. Think of it as your brain wearing a disguise, appearing older than its actual years,” Dr. Lakhan said.
“Inflammation, a key player in osteoarthritis, might be playing a double agent, wreaking havoc not just on your joints but potentially on your memory too. Researchers even identified a specific gene linked to both knee pain and faster brain aging, hinting at a potential target for future treatments,” he added.
“Importantly, the increased risk of cognitive decline and dementia associated with chronic pain is likely one of many factors, and probably not a very high one on its own,” Dr. Lakhan noted.
The “good news,” he said, is that there are many “well-established ways to keep your brain sharp. Regular exercise, a healthy diet, and staying mentally stimulated are all proven strategies to reduce dementia risk. Think of chronic pain management as another tool you can add to your brain health toolbox.”
Support for the study was provided by the STI-2030 Major Project, the National Natural Science Foundation of China, the Scientific Foundation of the Institute of Psychology, Chinese Academy of Sciences, and the Young Elite Scientist Sponsorship Program by the China Association for Science and Technology. Dr. Liu and Dr. Lakhan had no relevant disclosures.
A version of this article appeared on Medscape.com.
, new research showed.
Using structural MRI data from more than 9000 adults with knee osteoarthritis (KOA) from the UK Biobank, investigators developed a brain age model to compare an individual’s brain age with their chronological age. Those with KOA showed a much faster rate of brain aging than healthy individuals.
The acceleration in brain aging was largely driven by the hippocampus and predicted memory decline and incident dementia during follow-up. Researchers identified a gene highly expressed in glial cells as a possible genetic factor for accelerated brain aging.
“We demonstrate the accelerated brain aging and cognitive decline in chronic musculoskeletal pain, in particular knee osteoarthritis, and provide a neural marker for early detection and intervention,” said co-first author Jiao Liu, PhD candidate, Chinese Academy of Sciences, Beijing.
“We are interested to know how to slow down the aging brain in chronic musculoskeletal pain patients. Proper exercise and lifestyle may reduce the risk,” Dr. Liu said.
The study was published online in Nature Mental Health.
Common Condition
CMP affects more than 40% of the world’s population and has been shown to have a harmful impact on cognitive function, although the exact mechanisms remain unclear. Prior research suggests that inflammatory markers associated with brain aging are higher in patients with CMP, suggesting a link between brain aging and CMP.
To investigate further, researchers explored patterns of brain aging in healthy cohorts and cohorts with four common types of CMP — chronic knee pain, chronic back pain, chronic neck pain, and chronic hip pain.
Using their brain age model, investigators observed significantly increased brain aging, or “predicted age difference,” only in individuals with KOA (P < .001). The observation was validated in an independent dataset (P = .020), suggesting a pattern of brain aging acceleration specific to KOA.
This acceleration was primarily driven by key brain regions involved in cognitive processing, including hippocampus and orbitofrontal cortex, and was correlated with longitudinal memory decline and dementia risk.
These data also suggest that the SLC39A8 gene, which is highly expressed in glial cells, might be a key genetic factor underpinning this acceleration.
“We not only revealed the specificity of accelerated brain aging in knee osteoarthritis patients, but importantly, we also provided longitudinal evidence suggesting the ability of our brain aging marker to predict future memory decline and increased dementia risk,” corresponding author Yiheng Tu, PhD, also with Chinese Academy of Sciences, Beijing, said in a news release.
A Future Treatment Target?
Commenting on this research, Shaheen Lakhan, MD, PhD, a neurologist and researcher based in Miami, noted that in this study, people with KOA showed signs of “faster brain aging on scans. Think of it as your brain wearing a disguise, appearing older than its actual years,” Dr. Lakhan said.
“Inflammation, a key player in osteoarthritis, might be playing a double agent, wreaking havoc not just on your joints but potentially on your memory too. Researchers even identified a specific gene linked to both knee pain and faster brain aging, hinting at a potential target for future treatments,” he added.
“Importantly, the increased risk of cognitive decline and dementia associated with chronic pain is likely one of many factors, and probably not a very high one on its own,” Dr. Lakhan noted.
The “good news,” he said, is that there are many “well-established ways to keep your brain sharp. Regular exercise, a healthy diet, and staying mentally stimulated are all proven strategies to reduce dementia risk. Think of chronic pain management as another tool you can add to your brain health toolbox.”
Support for the study was provided by the STI-2030 Major Project, the National Natural Science Foundation of China, the Scientific Foundation of the Institute of Psychology, Chinese Academy of Sciences, and the Young Elite Scientist Sponsorship Program by the China Association for Science and Technology. Dr. Liu and Dr. Lakhan had no relevant disclosures.
A version of this article appeared on Medscape.com.
, new research showed.
Using structural MRI data from more than 9000 adults with knee osteoarthritis (KOA) from the UK Biobank, investigators developed a brain age model to compare an individual’s brain age with their chronological age. Those with KOA showed a much faster rate of brain aging than healthy individuals.
The acceleration in brain aging was largely driven by the hippocampus and predicted memory decline and incident dementia during follow-up. Researchers identified a gene highly expressed in glial cells as a possible genetic factor for accelerated brain aging.
“We demonstrate the accelerated brain aging and cognitive decline in chronic musculoskeletal pain, in particular knee osteoarthritis, and provide a neural marker for early detection and intervention,” said co-first author Jiao Liu, PhD candidate, Chinese Academy of Sciences, Beijing.
“We are interested to know how to slow down the aging brain in chronic musculoskeletal pain patients. Proper exercise and lifestyle may reduce the risk,” Dr. Liu said.
The study was published online in Nature Mental Health.
Common Condition
CMP affects more than 40% of the world’s population and has been shown to have a harmful impact on cognitive function, although the exact mechanisms remain unclear. Prior research suggests that inflammatory markers associated with brain aging are higher in patients with CMP, suggesting a link between brain aging and CMP.
To investigate further, researchers explored patterns of brain aging in healthy cohorts and cohorts with four common types of CMP — chronic knee pain, chronic back pain, chronic neck pain, and chronic hip pain.
Using their brain age model, investigators observed significantly increased brain aging, or “predicted age difference,” only in individuals with KOA (P < .001). The observation was validated in an independent dataset (P = .020), suggesting a pattern of brain aging acceleration specific to KOA.
This acceleration was primarily driven by key brain regions involved in cognitive processing, including hippocampus and orbitofrontal cortex, and was correlated with longitudinal memory decline and dementia risk.
These data also suggest that the SLC39A8 gene, which is highly expressed in glial cells, might be a key genetic factor underpinning this acceleration.
“We not only revealed the specificity of accelerated brain aging in knee osteoarthritis patients, but importantly, we also provided longitudinal evidence suggesting the ability of our brain aging marker to predict future memory decline and increased dementia risk,” corresponding author Yiheng Tu, PhD, also with Chinese Academy of Sciences, Beijing, said in a news release.
A Future Treatment Target?
Commenting on this research, Shaheen Lakhan, MD, PhD, a neurologist and researcher based in Miami, noted that in this study, people with KOA showed signs of “faster brain aging on scans. Think of it as your brain wearing a disguise, appearing older than its actual years,” Dr. Lakhan said.
“Inflammation, a key player in osteoarthritis, might be playing a double agent, wreaking havoc not just on your joints but potentially on your memory too. Researchers even identified a specific gene linked to both knee pain and faster brain aging, hinting at a potential target for future treatments,” he added.
“Importantly, the increased risk of cognitive decline and dementia associated with chronic pain is likely one of many factors, and probably not a very high one on its own,” Dr. Lakhan noted.
The “good news,” he said, is that there are many “well-established ways to keep your brain sharp. Regular exercise, a healthy diet, and staying mentally stimulated are all proven strategies to reduce dementia risk. Think of chronic pain management as another tool you can add to your brain health toolbox.”
Support for the study was provided by the STI-2030 Major Project, the National Natural Science Foundation of China, the Scientific Foundation of the Institute of Psychology, Chinese Academy of Sciences, and the Young Elite Scientist Sponsorship Program by the China Association for Science and Technology. Dr. Liu and Dr. Lakhan had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM NATURE MENTAL HEALTH
Researchers Seek to Block Use of FDA-Approved OUD-Risk Test
A group of researchers urged US regulators to revoke the approval of a test marketed for predicting risk for opioid addiction and said government health plans should not pay for the product.
The focus of the request is AdvertD (SOLVD Health), which the US Food and Drug Administration (FDA) approved in December as the first test to use DNA to evaluate if people have an elevated risk for opioid use disorder (OUD). A sample obtained through a cheek swab is meant to help guide decisions about opioid prescriptions for patients not previously treated with these drugs, such as someone undergoing a planned surgery, the FDA said.
But Michael T. Abrams, MPH, PhD, senior health researcher for Public Citizen’s Health Research Group, and 30 other physicians and researchers sent an April 4 letter to the Food and Drug Administration calling on the government to reconsider.
Dr. Abrams and fellow signers of the letters, including longtime opioid watchdog Andrew Kolodny, MD, of Brandeis University, said the algorithm used in creating AvertD “fell into known pitfalls of genetic prediction that give the appearance of predicting genetic risk, without being a true measure of genetic risk.”
The letter adds that false-positive test results may result in harmful consequences, with clinicians refraining from prescribing needed opioids, a problem that may be magnified in minority populations.
Among the signers of the letter is Alexander Hatoum, PhD, of Washington University, who conducted an independent evaluation of AdvertD, which he and his colleagues published in 2021 in Drug and Alcohol Dependency.
Dr. Hatoum said many patients may not fully understand the limit of genetic testing in predicting conditions like risk for OUD, where many factors are at play. The availability of a test may lend the impression that a single DNA trait makes the difference, as happens with conditions like Huntington’s disease and cystic fibrosis, he said.
“But it’s just not reality for most diseases,” Dr. Hatoum told this news organization.
The FDA declined to comment on the letter and said its approval of the test was “another step forward” in efforts to prevent new cases of OUD.
In 2021, a little more than three quarters of people who died by overdose in the United States involved opioids, or more than 80,000 people, according to the US Centers for Disease Control and Prevention. This figure includes prescription opioids, heroin, and fentanyl.
While deaths from overdoses with prescription opioids peaked in 2017 at 17,029 people, that figure has decreased steadily. Meanwhile, synthetic opioids other than methadone — primarily fentanyl — were the main driver of drug overdose deaths with a nearly 7.5-fold increase from 2015 to 2021.
The FDA agency said it had “a reasonable assurance of AvertD’s safety and effectiveness, taking into consideration available alternatives, patients’ perspectives, the public health need and the ability to address uncertainty through the collection of post-market data.”
Slow Rollout
In a separate letter to the Centers for Medicare and Medicaid Services, Dr. Abrams, Dr. Kolodny, Dr. Hatoum, and the other signers repeated their arguments against the use of AdvertD and asked that the government not use federal funds to pay for the test.
SOLVD is not yet selling AdvertD in the United States, and it has not yet set a price for the product. The Carlsbad, California-based company told this news organization in an email exchange that it is working with both Medicare and private insurers on questions of future coverage.
AvertD correctly identified an elevated risk for OUD in about 82.8% of cases, equating to a false-negative rate of 18.2% of patients, the FDA said in its summary of on the data supporting the application. This measure is known as sensitivity, meaning it shows how often an individual has the condition addressed in the test.
Meanwhile, the false positive rate was 20.8%, the FDA said.
SOLVD published similar study results in 2021.
The company failed to impress the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel, which in October 2022, said the probable risks of the test likely outweighed its benefits.
Then, in November 2022, the FDA and National Institutes of Health (NIH) held a public workshop meeting to consider the challenges and possibilities in developing tools to predict the risk of developing OUD. At that meeting, Keri Donaldson, MD, MSCE, the chief executive officer of SOLVD, said the company planned to conduct a controlled rollout of AdvertD on FDA approval.
Dr. Donaldson said a “defined set” of clinicians would first access the test, allowing the company to understand how results would be used in clinical practice.
“Once a test gets into practice, you have to be very purposeful and thoughtful about how it’s used,” he said.
The FDA approved the test in December 2023, saying it had worked with the company on modifications to its test. It also said that the advisory committee’s feedback helped in the evaluation and ultimate approval of AdvertD.
Even beyond the debate about the predictive ability of genetic tests for OUD are larger questions that physicians need time to ask patients in assessing their potential risk for addiction when prescribing narcotic painkillers, said Maya Hambright, MD, a physician in New York’s Hudson Valley who has been working mainly in addiction in response to the overdose crisis.
Genetics are just one of many factors at play in causing people to become addicted to opioids, Dr. Hambright said.
Physicians must also consider the lasting effects of emotional and physical trauma experienced at any age, but particularly in childhood, as well as what kind of social support a patient has in facing the illness or injury that may require opioids for pain, she said.
“There is a time and place for narcotic medications to be prescribed appropriately, which means we have to do our due diligence,” Dr. Hambright told this news organization. “Regardless of the strides we make in research and development, we still must connect and communicate safely and effectively and compassionately with our patients.”
A version of this article appeared on Medscape.com.
A group of researchers urged US regulators to revoke the approval of a test marketed for predicting risk for opioid addiction and said government health plans should not pay for the product.
The focus of the request is AdvertD (SOLVD Health), which the US Food and Drug Administration (FDA) approved in December as the first test to use DNA to evaluate if people have an elevated risk for opioid use disorder (OUD). A sample obtained through a cheek swab is meant to help guide decisions about opioid prescriptions for patients not previously treated with these drugs, such as someone undergoing a planned surgery, the FDA said.
But Michael T. Abrams, MPH, PhD, senior health researcher for Public Citizen’s Health Research Group, and 30 other physicians and researchers sent an April 4 letter to the Food and Drug Administration calling on the government to reconsider.
Dr. Abrams and fellow signers of the letters, including longtime opioid watchdog Andrew Kolodny, MD, of Brandeis University, said the algorithm used in creating AvertD “fell into known pitfalls of genetic prediction that give the appearance of predicting genetic risk, without being a true measure of genetic risk.”
The letter adds that false-positive test results may result in harmful consequences, with clinicians refraining from prescribing needed opioids, a problem that may be magnified in minority populations.
Among the signers of the letter is Alexander Hatoum, PhD, of Washington University, who conducted an independent evaluation of AdvertD, which he and his colleagues published in 2021 in Drug and Alcohol Dependency.
Dr. Hatoum said many patients may not fully understand the limit of genetic testing in predicting conditions like risk for OUD, where many factors are at play. The availability of a test may lend the impression that a single DNA trait makes the difference, as happens with conditions like Huntington’s disease and cystic fibrosis, he said.
“But it’s just not reality for most diseases,” Dr. Hatoum told this news organization.
The FDA declined to comment on the letter and said its approval of the test was “another step forward” in efforts to prevent new cases of OUD.
In 2021, a little more than three quarters of people who died by overdose in the United States involved opioids, or more than 80,000 people, according to the US Centers for Disease Control and Prevention. This figure includes prescription opioids, heroin, and fentanyl.
While deaths from overdoses with prescription opioids peaked in 2017 at 17,029 people, that figure has decreased steadily. Meanwhile, synthetic opioids other than methadone — primarily fentanyl — were the main driver of drug overdose deaths with a nearly 7.5-fold increase from 2015 to 2021.
The FDA agency said it had “a reasonable assurance of AvertD’s safety and effectiveness, taking into consideration available alternatives, patients’ perspectives, the public health need and the ability to address uncertainty through the collection of post-market data.”
Slow Rollout
In a separate letter to the Centers for Medicare and Medicaid Services, Dr. Abrams, Dr. Kolodny, Dr. Hatoum, and the other signers repeated their arguments against the use of AdvertD and asked that the government not use federal funds to pay for the test.
SOLVD is not yet selling AdvertD in the United States, and it has not yet set a price for the product. The Carlsbad, California-based company told this news organization in an email exchange that it is working with both Medicare and private insurers on questions of future coverage.
AvertD correctly identified an elevated risk for OUD in about 82.8% of cases, equating to a false-negative rate of 18.2% of patients, the FDA said in its summary of on the data supporting the application. This measure is known as sensitivity, meaning it shows how often an individual has the condition addressed in the test.
Meanwhile, the false positive rate was 20.8%, the FDA said.
SOLVD published similar study results in 2021.
The company failed to impress the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel, which in October 2022, said the probable risks of the test likely outweighed its benefits.
Then, in November 2022, the FDA and National Institutes of Health (NIH) held a public workshop meeting to consider the challenges and possibilities in developing tools to predict the risk of developing OUD. At that meeting, Keri Donaldson, MD, MSCE, the chief executive officer of SOLVD, said the company planned to conduct a controlled rollout of AdvertD on FDA approval.
Dr. Donaldson said a “defined set” of clinicians would first access the test, allowing the company to understand how results would be used in clinical practice.
“Once a test gets into practice, you have to be very purposeful and thoughtful about how it’s used,” he said.
The FDA approved the test in December 2023, saying it had worked with the company on modifications to its test. It also said that the advisory committee’s feedback helped in the evaluation and ultimate approval of AdvertD.
Even beyond the debate about the predictive ability of genetic tests for OUD are larger questions that physicians need time to ask patients in assessing their potential risk for addiction when prescribing narcotic painkillers, said Maya Hambright, MD, a physician in New York’s Hudson Valley who has been working mainly in addiction in response to the overdose crisis.
Genetics are just one of many factors at play in causing people to become addicted to opioids, Dr. Hambright said.
Physicians must also consider the lasting effects of emotional and physical trauma experienced at any age, but particularly in childhood, as well as what kind of social support a patient has in facing the illness or injury that may require opioids for pain, she said.
“There is a time and place for narcotic medications to be prescribed appropriately, which means we have to do our due diligence,” Dr. Hambright told this news organization. “Regardless of the strides we make in research and development, we still must connect and communicate safely and effectively and compassionately with our patients.”
A version of this article appeared on Medscape.com.
A group of researchers urged US regulators to revoke the approval of a test marketed for predicting risk for opioid addiction and said government health plans should not pay for the product.
The focus of the request is AdvertD (SOLVD Health), which the US Food and Drug Administration (FDA) approved in December as the first test to use DNA to evaluate if people have an elevated risk for opioid use disorder (OUD). A sample obtained through a cheek swab is meant to help guide decisions about opioid prescriptions for patients not previously treated with these drugs, such as someone undergoing a planned surgery, the FDA said.
But Michael T. Abrams, MPH, PhD, senior health researcher for Public Citizen’s Health Research Group, and 30 other physicians and researchers sent an April 4 letter to the Food and Drug Administration calling on the government to reconsider.
Dr. Abrams and fellow signers of the letters, including longtime opioid watchdog Andrew Kolodny, MD, of Brandeis University, said the algorithm used in creating AvertD “fell into known pitfalls of genetic prediction that give the appearance of predicting genetic risk, without being a true measure of genetic risk.”
The letter adds that false-positive test results may result in harmful consequences, with clinicians refraining from prescribing needed opioids, a problem that may be magnified in minority populations.
Among the signers of the letter is Alexander Hatoum, PhD, of Washington University, who conducted an independent evaluation of AdvertD, which he and his colleagues published in 2021 in Drug and Alcohol Dependency.
Dr. Hatoum said many patients may not fully understand the limit of genetic testing in predicting conditions like risk for OUD, where many factors are at play. The availability of a test may lend the impression that a single DNA trait makes the difference, as happens with conditions like Huntington’s disease and cystic fibrosis, he said.
“But it’s just not reality for most diseases,” Dr. Hatoum told this news organization.
The FDA declined to comment on the letter and said its approval of the test was “another step forward” in efforts to prevent new cases of OUD.
In 2021, a little more than three quarters of people who died by overdose in the United States involved opioids, or more than 80,000 people, according to the US Centers for Disease Control and Prevention. This figure includes prescription opioids, heroin, and fentanyl.
While deaths from overdoses with prescription opioids peaked in 2017 at 17,029 people, that figure has decreased steadily. Meanwhile, synthetic opioids other than methadone — primarily fentanyl — were the main driver of drug overdose deaths with a nearly 7.5-fold increase from 2015 to 2021.
The FDA agency said it had “a reasonable assurance of AvertD’s safety and effectiveness, taking into consideration available alternatives, patients’ perspectives, the public health need and the ability to address uncertainty through the collection of post-market data.”
Slow Rollout
In a separate letter to the Centers for Medicare and Medicaid Services, Dr. Abrams, Dr. Kolodny, Dr. Hatoum, and the other signers repeated their arguments against the use of AdvertD and asked that the government not use federal funds to pay for the test.
SOLVD is not yet selling AdvertD in the United States, and it has not yet set a price for the product. The Carlsbad, California-based company told this news organization in an email exchange that it is working with both Medicare and private insurers on questions of future coverage.
AvertD correctly identified an elevated risk for OUD in about 82.8% of cases, equating to a false-negative rate of 18.2% of patients, the FDA said in its summary of on the data supporting the application. This measure is known as sensitivity, meaning it shows how often an individual has the condition addressed in the test.
Meanwhile, the false positive rate was 20.8%, the FDA said.
SOLVD published similar study results in 2021.
The company failed to impress the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel, which in October 2022, said the probable risks of the test likely outweighed its benefits.
Then, in November 2022, the FDA and National Institutes of Health (NIH) held a public workshop meeting to consider the challenges and possibilities in developing tools to predict the risk of developing OUD. At that meeting, Keri Donaldson, MD, MSCE, the chief executive officer of SOLVD, said the company planned to conduct a controlled rollout of AdvertD on FDA approval.
Dr. Donaldson said a “defined set” of clinicians would first access the test, allowing the company to understand how results would be used in clinical practice.
“Once a test gets into practice, you have to be very purposeful and thoughtful about how it’s used,” he said.
The FDA approved the test in December 2023, saying it had worked with the company on modifications to its test. It also said that the advisory committee’s feedback helped in the evaluation and ultimate approval of AdvertD.
Even beyond the debate about the predictive ability of genetic tests for OUD are larger questions that physicians need time to ask patients in assessing their potential risk for addiction when prescribing narcotic painkillers, said Maya Hambright, MD, a physician in New York’s Hudson Valley who has been working mainly in addiction in response to the overdose crisis.
Genetics are just one of many factors at play in causing people to become addicted to opioids, Dr. Hambright said.
Physicians must also consider the lasting effects of emotional and physical trauma experienced at any age, but particularly in childhood, as well as what kind of social support a patient has in facing the illness or injury that may require opioids for pain, she said.
“There is a time and place for narcotic medications to be prescribed appropriately, which means we have to do our due diligence,” Dr. Hambright told this news organization. “Regardless of the strides we make in research and development, we still must connect and communicate safely and effectively and compassionately with our patients.”
A version of this article appeared on Medscape.com.
Virtual Reality Brings Relief to Hospitalized Patients With Cancer
suggests a new randomized controlled trial.
While both interventions brought some pain relief, VR therapy yielded greater, longer-lasting comfort, reported lead author Hunter Groninger, MD, of MedStar Health Research Institute, Hyattsville, Maryland, and colleagues.
“Investigators have explored immersive VR interventions in cancer populations for a variety of indications including anxiety, depression, fatigue, and procedure‐associated pain, particularly among patients with pediatric cancer and adult breast cancer,” the investigators wrote in Cancer. “Nevertheless, despite growing evidence supporting the efficacy of VR‐delivered interventions for analgesia, few data address its role to mitigate cancer‐related pain specifically.”
To address this knowledge gap, Dr. Groninger and colleagues enrolled 128 adult hospitalized patients with cancer of any kind, all of whom had moderate to severe pain (self-reported score at least 4 out of 10) within the past 24 hours.
Study Methods and Results
Patients were randomized to receive either 10 minutes of immersive VR distraction therapy or 10 minutes of two-dimensional guided imagery distraction therapy.
“[The VR therapy] provides noncompetitive experiences in which the user can move around and explore natural environments (e.g., beachscape, forest) from standing, seated, or fixed positions, including within a hospital bed or chair,” the investigators wrote. “We provided over‐the‐ear headphones to assure high sound quality for the experience in the virtual natural environment.”
The two-dimensional intervention, delivered via electronic tablet, featured a meditation with images of natural landscapes and instrumental background music.
“We chose this active control because it is readily available and reflects content similar to relaxation‐focused television channels that are increasingly common in hospital settings,” the investigators noted.
Compared with this more common approach, patients who received VR therapy had significantly greater immediate reduction in pain (mean change in pain score, –1.4 vs –0.7; P = .03). Twenty-four hours later, improvements in the VR group generally persisted, while pain level in the two-dimensional group returned almost to baseline (P = .004). In addition, patients in the VR group reported significantly greater improvements in general distress and pain bothersomeness.
“VR therapies may modulate the pain experience by reducing the level of attention paid to noxious stimuli, thereby suppressing transmission of painful sensations via pain processing pathways to the cerebral cortex, particularly with more active VR experiences compared to passive experiences,” the investigators wrote.
Downsides to Using VR
Although VR brought more benefit, participants in the VR group more often reported difficulty using the intervention compared with those who interacted with an electronic tablet.
Plus, one VR user described mild dizziness that resolved with pharmacologic intervention. Still, approximately 9 out of 10 participants in each group reported willingness to try the intervention again.
Future VR Research
“Virtual reality is a rapidly evolving technology with a wealth of potential patient‐facing applications,” the investigators wrote. “Future studies should explore repeated use, optimal dosing, and impact on VR therapy on opioid analgesic requirements as well as usability testing, VR content preferences and facilitators of analgesia, and barriers and facilitators to use in acute care settings.”
This study was supported by the American Cancer Society. The investigators disclosed no conflicts of interest.
suggests a new randomized controlled trial.
While both interventions brought some pain relief, VR therapy yielded greater, longer-lasting comfort, reported lead author Hunter Groninger, MD, of MedStar Health Research Institute, Hyattsville, Maryland, and colleagues.
“Investigators have explored immersive VR interventions in cancer populations for a variety of indications including anxiety, depression, fatigue, and procedure‐associated pain, particularly among patients with pediatric cancer and adult breast cancer,” the investigators wrote in Cancer. “Nevertheless, despite growing evidence supporting the efficacy of VR‐delivered interventions for analgesia, few data address its role to mitigate cancer‐related pain specifically.”
To address this knowledge gap, Dr. Groninger and colleagues enrolled 128 adult hospitalized patients with cancer of any kind, all of whom had moderate to severe pain (self-reported score at least 4 out of 10) within the past 24 hours.
Study Methods and Results
Patients were randomized to receive either 10 minutes of immersive VR distraction therapy or 10 minutes of two-dimensional guided imagery distraction therapy.
“[The VR therapy] provides noncompetitive experiences in which the user can move around and explore natural environments (e.g., beachscape, forest) from standing, seated, or fixed positions, including within a hospital bed or chair,” the investigators wrote. “We provided over‐the‐ear headphones to assure high sound quality for the experience in the virtual natural environment.”
The two-dimensional intervention, delivered via electronic tablet, featured a meditation with images of natural landscapes and instrumental background music.
“We chose this active control because it is readily available and reflects content similar to relaxation‐focused television channels that are increasingly common in hospital settings,” the investigators noted.
Compared with this more common approach, patients who received VR therapy had significantly greater immediate reduction in pain (mean change in pain score, –1.4 vs –0.7; P = .03). Twenty-four hours later, improvements in the VR group generally persisted, while pain level in the two-dimensional group returned almost to baseline (P = .004). In addition, patients in the VR group reported significantly greater improvements in general distress and pain bothersomeness.
“VR therapies may modulate the pain experience by reducing the level of attention paid to noxious stimuli, thereby suppressing transmission of painful sensations via pain processing pathways to the cerebral cortex, particularly with more active VR experiences compared to passive experiences,” the investigators wrote.
Downsides to Using VR
Although VR brought more benefit, participants in the VR group more often reported difficulty using the intervention compared with those who interacted with an electronic tablet.
Plus, one VR user described mild dizziness that resolved with pharmacologic intervention. Still, approximately 9 out of 10 participants in each group reported willingness to try the intervention again.
Future VR Research
“Virtual reality is a rapidly evolving technology with a wealth of potential patient‐facing applications,” the investigators wrote. “Future studies should explore repeated use, optimal dosing, and impact on VR therapy on opioid analgesic requirements as well as usability testing, VR content preferences and facilitators of analgesia, and barriers and facilitators to use in acute care settings.”
This study was supported by the American Cancer Society. The investigators disclosed no conflicts of interest.
suggests a new randomized controlled trial.
While both interventions brought some pain relief, VR therapy yielded greater, longer-lasting comfort, reported lead author Hunter Groninger, MD, of MedStar Health Research Institute, Hyattsville, Maryland, and colleagues.
“Investigators have explored immersive VR interventions in cancer populations for a variety of indications including anxiety, depression, fatigue, and procedure‐associated pain, particularly among patients with pediatric cancer and adult breast cancer,” the investigators wrote in Cancer. “Nevertheless, despite growing evidence supporting the efficacy of VR‐delivered interventions for analgesia, few data address its role to mitigate cancer‐related pain specifically.”
To address this knowledge gap, Dr. Groninger and colleagues enrolled 128 adult hospitalized patients with cancer of any kind, all of whom had moderate to severe pain (self-reported score at least 4 out of 10) within the past 24 hours.
Study Methods and Results
Patients were randomized to receive either 10 minutes of immersive VR distraction therapy or 10 minutes of two-dimensional guided imagery distraction therapy.
“[The VR therapy] provides noncompetitive experiences in which the user can move around and explore natural environments (e.g., beachscape, forest) from standing, seated, or fixed positions, including within a hospital bed or chair,” the investigators wrote. “We provided over‐the‐ear headphones to assure high sound quality for the experience in the virtual natural environment.”
The two-dimensional intervention, delivered via electronic tablet, featured a meditation with images of natural landscapes and instrumental background music.
“We chose this active control because it is readily available and reflects content similar to relaxation‐focused television channels that are increasingly common in hospital settings,” the investigators noted.
Compared with this more common approach, patients who received VR therapy had significantly greater immediate reduction in pain (mean change in pain score, –1.4 vs –0.7; P = .03). Twenty-four hours later, improvements in the VR group generally persisted, while pain level in the two-dimensional group returned almost to baseline (P = .004). In addition, patients in the VR group reported significantly greater improvements in general distress and pain bothersomeness.
“VR therapies may modulate the pain experience by reducing the level of attention paid to noxious stimuli, thereby suppressing transmission of painful sensations via pain processing pathways to the cerebral cortex, particularly with more active VR experiences compared to passive experiences,” the investigators wrote.
Downsides to Using VR
Although VR brought more benefit, participants in the VR group more often reported difficulty using the intervention compared with those who interacted with an electronic tablet.
Plus, one VR user described mild dizziness that resolved with pharmacologic intervention. Still, approximately 9 out of 10 participants in each group reported willingness to try the intervention again.
Future VR Research
“Virtual reality is a rapidly evolving technology with a wealth of potential patient‐facing applications,” the investigators wrote. “Future studies should explore repeated use, optimal dosing, and impact on VR therapy on opioid analgesic requirements as well as usability testing, VR content preferences and facilitators of analgesia, and barriers and facilitators to use in acute care settings.”
This study was supported by the American Cancer Society. The investigators disclosed no conflicts of interest.
FROM CANCER
Should Opioids Be Used for Chronic Cancer Pain?
These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.
“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
Who Should Manage Chronic Cancer Pain?
Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.
“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?
To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.
These interviews yielded three themes.
First, no “medical home” exists for chronic pain management in cancer survivors.
“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.
Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.
“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”
The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.
“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”
Meanwhile, a palliative care provider described legal pressure from the opposite direction:
“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”
Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?
After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.
They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.
Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.
This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.
These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.
“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
Who Should Manage Chronic Cancer Pain?
Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.
“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?
To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.
These interviews yielded three themes.
First, no “medical home” exists for chronic pain management in cancer survivors.
“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.
Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.
“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”
The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.
“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”
Meanwhile, a palliative care provider described legal pressure from the opposite direction:
“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”
Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?
After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.
They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.
Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.
This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.
These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.
“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
Who Should Manage Chronic Cancer Pain?
Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.
“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?
To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.
These interviews yielded three themes.
First, no “medical home” exists for chronic pain management in cancer survivors.
“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.
Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.
“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”
The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.
“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”
Meanwhile, a palliative care provider described legal pressure from the opposite direction:
“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”
Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?
After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.
They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.
Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.
This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.
FROM CANCER
Erenumab Linked to Better Migraine Prevention
TOPLINE:
Earlier treatment with erenumab was associated with significantly better migraine prevention than that with nonspecific oral migraine preventive medications (OMPMs) in patients with resistant episodic migraine. Based on this research, the investigators suggest clinicians should start erenumab early and not prolong use of OMPMs.
METHODOLOGY:
- The 12-month prospective, international, multicenter, phase 4 randomized clinical APPRAISE trial included 621 adult patients (mean age, 41 years; 88% female) with a ≥ 12-month history of migraine and between 4 and 15 monthly migraine days (MMDs).
- Primary endpoint was the proportion of patients who completed 12 months of the initially assigned treatment and experiencing a reduction of ≥ 50% from baseline in MMDs at the end of the year.
- Secondary endpoints included cumulative mean change from baseline in MMDs during the treatment period and the proportion of responders (based on the Patients’ Global Impression of Change scale) at month 12 for patients taking the initially assigned treatment.
TAKEAWAY:
- At month 12, patients receiving erenumab were six times more likely to report a ≥ 50% reduction in MMDs than those receiving OMPMs (odds ratio [OR], 6.48; P < .001).
- Compared with OMPMs, treatment with erenumab yielded a higher responder rate at 1 year (76% vs 19%; OR, 13.75; P < .001) and a significantly greater reduction in cumulative average MMDs (−4.32 days vs −2.65 days; P < .001).
- Substantially, fewer patients in the erenumab vs the OMPM group switched medication (2% vs 35%) or discontinued treatment due to adverse events (3% vs 23%).
- Incidence of treatment-emergent adverse events was similar between the treatment arms (75% vs 76%) until the researchers adjusted for exposure to treatment, which revealed a roughly 30% lower exposure-adjusted rate (per 100 patient-years) in the erenumab group.
IN PRACTICE:
“Earlier initiation of erenumab may ultimately lead to fewer patients discontinuing or switching medication in a real-world clinical practice,” the authors wrote. In addition, the findings “lend further support to the recent guideline update issued by the European Headache Federation, in which CGRP-targeted mAbs are considered a first-line treatment option for patients with migraine who require preventive treatment.”
SOURCE:
Patricia Pozo-Rosich, MD, PhD, of the Headache and Neurological Pain Research Group, Vall d’Hebron Institute of Research, Department of Medicine, Universitat Autònoma de Barcelona, Spain, and the Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain, was the lead and corresponding author of the study. It was published online in JAMA Neurology.
LIMITATIONS:
Only locally approved and marketed OMPMs at study onset were used as comparators. The open-label study design might have led to a placebo response, which could have played a role in the findings because erenumab can only be administered in a clinic and was administered subcutaneously.
DISCLOSURES:
This study was funded by Novartis Pharma AG, Basel, Switzerland. Dr. Pozo-Rosich reported receiving grants from AbbVie, Novartis, and Teva and personal fees from AbbVie, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva outside the submitted work. The other authors’ disclosures were listed on the original paper.
A version of this article first appeared on Medscape.com.
TOPLINE:
Earlier treatment with erenumab was associated with significantly better migraine prevention than that with nonspecific oral migraine preventive medications (OMPMs) in patients with resistant episodic migraine. Based on this research, the investigators suggest clinicians should start erenumab early and not prolong use of OMPMs.
METHODOLOGY:
- The 12-month prospective, international, multicenter, phase 4 randomized clinical APPRAISE trial included 621 adult patients (mean age, 41 years; 88% female) with a ≥ 12-month history of migraine and between 4 and 15 monthly migraine days (MMDs).
- Primary endpoint was the proportion of patients who completed 12 months of the initially assigned treatment and experiencing a reduction of ≥ 50% from baseline in MMDs at the end of the year.
- Secondary endpoints included cumulative mean change from baseline in MMDs during the treatment period and the proportion of responders (based on the Patients’ Global Impression of Change scale) at month 12 for patients taking the initially assigned treatment.
TAKEAWAY:
- At month 12, patients receiving erenumab were six times more likely to report a ≥ 50% reduction in MMDs than those receiving OMPMs (odds ratio [OR], 6.48; P < .001).
- Compared with OMPMs, treatment with erenumab yielded a higher responder rate at 1 year (76% vs 19%; OR, 13.75; P < .001) and a significantly greater reduction in cumulative average MMDs (−4.32 days vs −2.65 days; P < .001).
- Substantially, fewer patients in the erenumab vs the OMPM group switched medication (2% vs 35%) or discontinued treatment due to adverse events (3% vs 23%).
- Incidence of treatment-emergent adverse events was similar between the treatment arms (75% vs 76%) until the researchers adjusted for exposure to treatment, which revealed a roughly 30% lower exposure-adjusted rate (per 100 patient-years) in the erenumab group.
IN PRACTICE:
“Earlier initiation of erenumab may ultimately lead to fewer patients discontinuing or switching medication in a real-world clinical practice,” the authors wrote. In addition, the findings “lend further support to the recent guideline update issued by the European Headache Federation, in which CGRP-targeted mAbs are considered a first-line treatment option for patients with migraine who require preventive treatment.”
SOURCE:
Patricia Pozo-Rosich, MD, PhD, of the Headache and Neurological Pain Research Group, Vall d’Hebron Institute of Research, Department of Medicine, Universitat Autònoma de Barcelona, Spain, and the Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain, was the lead and corresponding author of the study. It was published online in JAMA Neurology.
LIMITATIONS:
Only locally approved and marketed OMPMs at study onset were used as comparators. The open-label study design might have led to a placebo response, which could have played a role in the findings because erenumab can only be administered in a clinic and was administered subcutaneously.
DISCLOSURES:
This study was funded by Novartis Pharma AG, Basel, Switzerland. Dr. Pozo-Rosich reported receiving grants from AbbVie, Novartis, and Teva and personal fees from AbbVie, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva outside the submitted work. The other authors’ disclosures were listed on the original paper.
A version of this article first appeared on Medscape.com.
TOPLINE:
Earlier treatment with erenumab was associated with significantly better migraine prevention than that with nonspecific oral migraine preventive medications (OMPMs) in patients with resistant episodic migraine. Based on this research, the investigators suggest clinicians should start erenumab early and not prolong use of OMPMs.
METHODOLOGY:
- The 12-month prospective, international, multicenter, phase 4 randomized clinical APPRAISE trial included 621 adult patients (mean age, 41 years; 88% female) with a ≥ 12-month history of migraine and between 4 and 15 monthly migraine days (MMDs).
- Primary endpoint was the proportion of patients who completed 12 months of the initially assigned treatment and experiencing a reduction of ≥ 50% from baseline in MMDs at the end of the year.
- Secondary endpoints included cumulative mean change from baseline in MMDs during the treatment period and the proportion of responders (based on the Patients’ Global Impression of Change scale) at month 12 for patients taking the initially assigned treatment.
TAKEAWAY:
- At month 12, patients receiving erenumab were six times more likely to report a ≥ 50% reduction in MMDs than those receiving OMPMs (odds ratio [OR], 6.48; P < .001).
- Compared with OMPMs, treatment with erenumab yielded a higher responder rate at 1 year (76% vs 19%; OR, 13.75; P < .001) and a significantly greater reduction in cumulative average MMDs (−4.32 days vs −2.65 days; P < .001).
- Substantially, fewer patients in the erenumab vs the OMPM group switched medication (2% vs 35%) or discontinued treatment due to adverse events (3% vs 23%).
- Incidence of treatment-emergent adverse events was similar between the treatment arms (75% vs 76%) until the researchers adjusted for exposure to treatment, which revealed a roughly 30% lower exposure-adjusted rate (per 100 patient-years) in the erenumab group.
IN PRACTICE:
“Earlier initiation of erenumab may ultimately lead to fewer patients discontinuing or switching medication in a real-world clinical practice,” the authors wrote. In addition, the findings “lend further support to the recent guideline update issued by the European Headache Federation, in which CGRP-targeted mAbs are considered a first-line treatment option for patients with migraine who require preventive treatment.”
SOURCE:
Patricia Pozo-Rosich, MD, PhD, of the Headache and Neurological Pain Research Group, Vall d’Hebron Institute of Research, Department of Medicine, Universitat Autònoma de Barcelona, Spain, and the Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain, was the lead and corresponding author of the study. It was published online in JAMA Neurology.
LIMITATIONS:
Only locally approved and marketed OMPMs at study onset were used as comparators. The open-label study design might have led to a placebo response, which could have played a role in the findings because erenumab can only be administered in a clinic and was administered subcutaneously.
DISCLOSURES:
This study was funded by Novartis Pharma AG, Basel, Switzerland. Dr. Pozo-Rosich reported receiving grants from AbbVie, Novartis, and Teva and personal fees from AbbVie, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva outside the submitted work. The other authors’ disclosures were listed on the original paper.
A version of this article first appeared on Medscape.com.
Women’s Cancers: Clinicians Research, Advise on Sexual Dysfunction
Decreased sexual function is a side effect of many types of cancer, notably uterine, cervical, ovarian, and breast cancer, that often goes unaddressed, according to the authors of several studies presented at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer.
Patients want to talk about sex, but not necessarily at the start of their diagnosis or treatment, suggest the findings of a study presented at the meeting. Jesse T. Brewer of Weill Cornell Medicine in New York City and colleagues enrolled 63 patients who underwent surgery with documented hereditary breast cancer, ovarian cancer, or Lynch syndrome in a cross-sectional survey.
Overall, 86% said that sexuality and intimacy were very or somewhat important, and 78% said that the healthcare team addressing the issue was very or somewhat important, the researchers found. However, only 40% of the respondents said that they wanted to discuss sexuality at the time of diagnosis because the idea was too overwhelming.
Oncologists are more aware of sexual side effects and the potential for sexual issues that persist long after treatment, but many patients may not have opportunities to talk about sexual concerns, said Don S. Dizon, MD, an oncologist specializing in women’s cancers at Brown University, Providence, Rhode Island, in an interview.
“It is important that we [oncologists] be the ones to open the door to these conversations; people with cancer will not bring it up spontaneously, for fear of making their provider uncomfortable, especially if they’ve never been asked about it before,” Dr. Dizon said in an interview.
He advised clinicians to find a network within their health systems so they can refer patients to specialized services, such as sex therapy, couples counseling, pelvic rehabilitation, or menopausal experts as needed.
In another study presented at the meeting, Naaman Mehta, MD, of NYU Langone Health, and colleagues reviewed data from 166 healthcare providers who completed a 23-item survey about evaluating and managing sexual health concerns of their patients. Most of the respondents were gynecologic oncologists (93.4%), but one radiation oncologist and 10 other healthcare providers also completed the survey.
Overall, approximately 60% of the respondents routinely asked about the sexual health concerns of their patients, and 98% of these said they believed that sexual health discussions should be held with a gynecologic oncologist. Just over half (54%) also said that the patient should be the one to initiate a discussion of sexual health concerns.
Female providers were significantly more likely to discuss sexual health with patients, compared with male providers, after controlling for the hospital setting and training level, the researchers noted (odds ratio, 1.4;P < .01).
The results suggest a need for more ways to integrate sexual health screening into gynecologic oncologic clinics, the researchers concluded.
The provider survey findings are similar to the results of a survey conducted by Dr. Dizon and colleagues in 2007. In that study, less than half of respondents took a sexual history, but 80% felt there was insufficient time to explore sexual issues.
“It is critical to understand that people with cancer do not expect their oncologists to be sexual health experts, but as with all other side effects caused by treatment and the diagnosis, we can be the ones who recognize it,” Dr. Dizon noted, in an interview.
Common Complaints and Causes
In Dr. Dizon’s experience, local symptoms including vaginal dryness, pain with penetration, and vaginal thinning, are common sexual complaints in women with cancer, as are systemic issues such as lack of interest and menopause-type symptoms.
“For those undergoing radiation, the vaginal tunnel can actually develop adhesions, and if not treated proactively this can lead to vaginal stenosis,” said Dr. Dizon, who was not involved in the studies presented at the meeting.
Comorbidities such as diabetes, cardiovascular disease, and musculoskeletal conditions can contribute to sexual issues in women with cancer, according to Nora Lersch, DNP, FNP-BC, AOCNP, and Nicole Dreibelbis, CRNP, the authors of other research presented at the meeting.
Culture, religion, fitness level, history of sexual violence, and gender spectrum health also play a role, as do anxiety and depression, dementia, and substance abuse disorders, the authors wrote in their presentation, “Prioritizing Sexual Health in Gynecological Oncology Care.”
Low libido is a frequent complaint across all cancer types, Ms. Dreibelbis, a nurse practitioner specializing in gynecologic oncology at the UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, said in an interview.
“Breast cancer patients, especially those on [aromatase inhibitor] therapy, often experience vaginal dryness and therefore dyspareunia,” she added.
The pelvic floor muscles, with their important role in sexual response, can be weakened by cancer treatment or surgery, and the pudendal nerves, which are the primary nerves responsible for sexual response in women, can be affected as well, Dr. Lersch and Ms. Dreibelbis wrote.
Taking Sex Seriously
Researchers are exploring the impact of different cancer prevention treatments for women to mitigate sexual side effects, as illustrated by another study presented at the meeting.
Dr. Barbara Norquist, MD, a gynecologic oncologist at the University of Washington, Seattle, and colleagues compared the sexual function and menopausal symptoms of patients at high risk of ovarian carcinoma who underwent either interval salpingectomy/delayed oophorectomy (ISDO) or risk-reducing salpingo-oophorectomy (RRSO).
“For patients at high risk for ovarian cancer, surgical removal of the tubes and ovaries is the mainstay of prevention, as screening is not effective at reducing death from ovarian cancer. As a result of surgery, many patients become suddenly postmenopausal from losing their ovaries,” Dr. Norquist said in an interview.
Some patients delay surgery out of concern for health and quality of life, including sexual function, she said.
In the study (known as the WISP trial) the researchers compared data from 166 patients who underwent immediate removal of the fallopian tubes and ovaries and 171 who underwent fallopian tube removal and delayed oophorectomy. All patients completed questionnaires about sexual function. The primary outcome was change in sexual function based on the sexual function index (FSFI) from baseline to 6 months after surgery.
Overall, changes in sexual function were significantly greater in the immediate oophorectomy group, compared with the delayed oophorectomy group at 6 months (33% vs 17%) and also at 12 months (43% vs 20%).
A further review of patients using hormone therapy showed that those in the immediate oophorectomy group still had greater decreases in sexual function, compared with the delayed group, though the difference between groups of patients using hormone therapy was less dramatic.
“I was surprised that, even with hormone replacement therapy, patients undergoing removal of the ovaries still had significant detrimental changes to sexual function when compared to those having the tubes removed, although this was even worse in those who could not take HRT,” Dr. Norquist said, in an interview. “I was reassured that menopausal symptoms in general were well managed with HRT, as these patients did not score differently on menopause symptoms, compared with those having their tubes removed,” she said.
Patients deserve accurate information about predicted changes in menopausal symptoms and sexual function as a result of ovary removal, and HRT should be provided when there is no contraindication, Dr. Norquist told this news organization.
Dr. Norquist and colleagues are awaiting the results of clinical trials investigating the safety of salpingectomy with delayed oophorectomy in terms of ovarian cancer prevention, but more research is needed to identify optimal management of the menopausal and sexual side effects associated with surgical menopause, she noted.
“Findings from the WISP study show the importance of hormones in women undergoing prophylactic surgery,” Dr. Dizon said. The findings indicate that salpingectomy has less of a negative influence on sexual function compared to removal of the ovaries, and the impact of hormone therapy and the relatively young age of the patients who took hormones reinforces current knowledge about hormones and sex, he added.
Barriers and Solutions
Barriers to asking women with cancer about sexual issues reported by providers include limited time, lack of training in sexual health, a desire to avoid offending the patient or making them uncomfortable, and uncertainty about how to answer the questions, Dr. Lersch and Ms. Dreibelbis wrote in their presentation.
Barriers to asking healthcare providers about their sexual issues reported by patients include the beliefs that the clinician should initiate the discussion, that sexual function will not be taken seriously, and that they might make the provider uncomfortable.
“Fortunately, more information and research has been done on sexual health and gynecological cancer in recent years, so oncologists are becoming more aware of the issues women may have,” said Dr. Lersch who is an oncology nurse practitioner at Providence Franz Cancer Institute in Portland, Oregon, in an interview.
Telling patients early in their cancer treatment about potential sexual side effects and opportunities for help is essential, she added.
Although oncologists have become more aware of the importance of sexual health and well-being for their patients, “I think there has historically been a disconnect in including sexual health education in medical training,” Ms. Dreibelbis said in an interview.
Dr. Lersch and Ms. Dreibelbis advised a multidimensional approach to managing sexual problems in cancer patients that includes consideration of biological and psychological symptoms, but also social, cultural, and interpersonal factors, in their presentation.
Their suggestions include discussing dyspareunia with their patients, asking for details such as whether the pain is internal or external, whether it occurs with activities outside of sex including masturbation, and whether bleeding is present.
Oncology therapies and surgeries can decrease or eliminate an individual’s ability to produce their own lubricant; for example, removal of the cervix eliminates cervical mucous, which helps with internal lubrication, they wrote in their presentation.
For patients with dyspareunia, Dr. Lersch and Ms. Dreibelbis recommend a vaginal moisturizer especially formulated for vaginal tissue that can be absorbed by the mucosal tissue of the vagina. Use of this type of product can increase the effectiveness of lubricants and help restore integrity of the vaginal tissue. Such moisturizers are available as gels, creams, or suppositories over the counter, and do not contain hormones.
Vaginal estrogen can be helpful for burning, itching, irritation, tissue fragility, and pain with sex, according to Dr. Lersch and Ms. Dreibelbis. Adequate estrogen therapy can promote normalization of vaginal pH and microflora, as well increase vaginal secretion and reduce pain and dryness with intercourse, the presenters stated in their presentation. In addition, dilator therapy can be used to help prevent vaginal stenosis, and penetration bumpers can help relieve discomfort during intercourse, they wrote.
Looking ahead, more research is needed to serve a wider patient population, Ms. Dreibelbis said, in an interview.
“LGBTQIA [individuals] have not been included in sexual health research and there are more people than ever who identify within this group of people. I know there has also been some very early work on shielding the clitoris from the impacts of radiation, and I believe this is extremely important up-and-coming research,” she said.
Dr. Lersch, Ms. Dreibelbi, Dr. Dizon, Dr. Norquist, Ms. Brewer, and Dr. Mehta had no financial conflicts to disclose.
Decreased sexual function is a side effect of many types of cancer, notably uterine, cervical, ovarian, and breast cancer, that often goes unaddressed, according to the authors of several studies presented at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer.
Patients want to talk about sex, but not necessarily at the start of their diagnosis or treatment, suggest the findings of a study presented at the meeting. Jesse T. Brewer of Weill Cornell Medicine in New York City and colleagues enrolled 63 patients who underwent surgery with documented hereditary breast cancer, ovarian cancer, or Lynch syndrome in a cross-sectional survey.
Overall, 86% said that sexuality and intimacy were very or somewhat important, and 78% said that the healthcare team addressing the issue was very or somewhat important, the researchers found. However, only 40% of the respondents said that they wanted to discuss sexuality at the time of diagnosis because the idea was too overwhelming.
Oncologists are more aware of sexual side effects and the potential for sexual issues that persist long after treatment, but many patients may not have opportunities to talk about sexual concerns, said Don S. Dizon, MD, an oncologist specializing in women’s cancers at Brown University, Providence, Rhode Island, in an interview.
“It is important that we [oncologists] be the ones to open the door to these conversations; people with cancer will not bring it up spontaneously, for fear of making their provider uncomfortable, especially if they’ve never been asked about it before,” Dr. Dizon said in an interview.
He advised clinicians to find a network within their health systems so they can refer patients to specialized services, such as sex therapy, couples counseling, pelvic rehabilitation, or menopausal experts as needed.
In another study presented at the meeting, Naaman Mehta, MD, of NYU Langone Health, and colleagues reviewed data from 166 healthcare providers who completed a 23-item survey about evaluating and managing sexual health concerns of their patients. Most of the respondents were gynecologic oncologists (93.4%), but one radiation oncologist and 10 other healthcare providers also completed the survey.
Overall, approximately 60% of the respondents routinely asked about the sexual health concerns of their patients, and 98% of these said they believed that sexual health discussions should be held with a gynecologic oncologist. Just over half (54%) also said that the patient should be the one to initiate a discussion of sexual health concerns.
Female providers were significantly more likely to discuss sexual health with patients, compared with male providers, after controlling for the hospital setting and training level, the researchers noted (odds ratio, 1.4;P < .01).
The results suggest a need for more ways to integrate sexual health screening into gynecologic oncologic clinics, the researchers concluded.
The provider survey findings are similar to the results of a survey conducted by Dr. Dizon and colleagues in 2007. In that study, less than half of respondents took a sexual history, but 80% felt there was insufficient time to explore sexual issues.
“It is critical to understand that people with cancer do not expect their oncologists to be sexual health experts, but as with all other side effects caused by treatment and the diagnosis, we can be the ones who recognize it,” Dr. Dizon noted, in an interview.
Common Complaints and Causes
In Dr. Dizon’s experience, local symptoms including vaginal dryness, pain with penetration, and vaginal thinning, are common sexual complaints in women with cancer, as are systemic issues such as lack of interest and menopause-type symptoms.
“For those undergoing radiation, the vaginal tunnel can actually develop adhesions, and if not treated proactively this can lead to vaginal stenosis,” said Dr. Dizon, who was not involved in the studies presented at the meeting.
Comorbidities such as diabetes, cardiovascular disease, and musculoskeletal conditions can contribute to sexual issues in women with cancer, according to Nora Lersch, DNP, FNP-BC, AOCNP, and Nicole Dreibelbis, CRNP, the authors of other research presented at the meeting.
Culture, religion, fitness level, history of sexual violence, and gender spectrum health also play a role, as do anxiety and depression, dementia, and substance abuse disorders, the authors wrote in their presentation, “Prioritizing Sexual Health in Gynecological Oncology Care.”
Low libido is a frequent complaint across all cancer types, Ms. Dreibelbis, a nurse practitioner specializing in gynecologic oncology at the UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, said in an interview.
“Breast cancer patients, especially those on [aromatase inhibitor] therapy, often experience vaginal dryness and therefore dyspareunia,” she added.
The pelvic floor muscles, with their important role in sexual response, can be weakened by cancer treatment or surgery, and the pudendal nerves, which are the primary nerves responsible for sexual response in women, can be affected as well, Dr. Lersch and Ms. Dreibelbis wrote.
Taking Sex Seriously
Researchers are exploring the impact of different cancer prevention treatments for women to mitigate sexual side effects, as illustrated by another study presented at the meeting.
Dr. Barbara Norquist, MD, a gynecologic oncologist at the University of Washington, Seattle, and colleagues compared the sexual function and menopausal symptoms of patients at high risk of ovarian carcinoma who underwent either interval salpingectomy/delayed oophorectomy (ISDO) or risk-reducing salpingo-oophorectomy (RRSO).
“For patients at high risk for ovarian cancer, surgical removal of the tubes and ovaries is the mainstay of prevention, as screening is not effective at reducing death from ovarian cancer. As a result of surgery, many patients become suddenly postmenopausal from losing their ovaries,” Dr. Norquist said in an interview.
Some patients delay surgery out of concern for health and quality of life, including sexual function, she said.
In the study (known as the WISP trial) the researchers compared data from 166 patients who underwent immediate removal of the fallopian tubes and ovaries and 171 who underwent fallopian tube removal and delayed oophorectomy. All patients completed questionnaires about sexual function. The primary outcome was change in sexual function based on the sexual function index (FSFI) from baseline to 6 months after surgery.
Overall, changes in sexual function were significantly greater in the immediate oophorectomy group, compared with the delayed oophorectomy group at 6 months (33% vs 17%) and also at 12 months (43% vs 20%).
A further review of patients using hormone therapy showed that those in the immediate oophorectomy group still had greater decreases in sexual function, compared with the delayed group, though the difference between groups of patients using hormone therapy was less dramatic.
“I was surprised that, even with hormone replacement therapy, patients undergoing removal of the ovaries still had significant detrimental changes to sexual function when compared to those having the tubes removed, although this was even worse in those who could not take HRT,” Dr. Norquist said, in an interview. “I was reassured that menopausal symptoms in general were well managed with HRT, as these patients did not score differently on menopause symptoms, compared with those having their tubes removed,” she said.
Patients deserve accurate information about predicted changes in menopausal symptoms and sexual function as a result of ovary removal, and HRT should be provided when there is no contraindication, Dr. Norquist told this news organization.
Dr. Norquist and colleagues are awaiting the results of clinical trials investigating the safety of salpingectomy with delayed oophorectomy in terms of ovarian cancer prevention, but more research is needed to identify optimal management of the menopausal and sexual side effects associated with surgical menopause, she noted.
“Findings from the WISP study show the importance of hormones in women undergoing prophylactic surgery,” Dr. Dizon said. The findings indicate that salpingectomy has less of a negative influence on sexual function compared to removal of the ovaries, and the impact of hormone therapy and the relatively young age of the patients who took hormones reinforces current knowledge about hormones and sex, he added.
Barriers and Solutions
Barriers to asking women with cancer about sexual issues reported by providers include limited time, lack of training in sexual health, a desire to avoid offending the patient or making them uncomfortable, and uncertainty about how to answer the questions, Dr. Lersch and Ms. Dreibelbis wrote in their presentation.
Barriers to asking healthcare providers about their sexual issues reported by patients include the beliefs that the clinician should initiate the discussion, that sexual function will not be taken seriously, and that they might make the provider uncomfortable.
“Fortunately, more information and research has been done on sexual health and gynecological cancer in recent years, so oncologists are becoming more aware of the issues women may have,” said Dr. Lersch who is an oncology nurse practitioner at Providence Franz Cancer Institute in Portland, Oregon, in an interview.
Telling patients early in their cancer treatment about potential sexual side effects and opportunities for help is essential, she added.
Although oncologists have become more aware of the importance of sexual health and well-being for their patients, “I think there has historically been a disconnect in including sexual health education in medical training,” Ms. Dreibelbis said in an interview.
Dr. Lersch and Ms. Dreibelbis advised a multidimensional approach to managing sexual problems in cancer patients that includes consideration of biological and psychological symptoms, but also social, cultural, and interpersonal factors, in their presentation.
Their suggestions include discussing dyspareunia with their patients, asking for details such as whether the pain is internal or external, whether it occurs with activities outside of sex including masturbation, and whether bleeding is present.
Oncology therapies and surgeries can decrease or eliminate an individual’s ability to produce their own lubricant; for example, removal of the cervix eliminates cervical mucous, which helps with internal lubrication, they wrote in their presentation.
For patients with dyspareunia, Dr. Lersch and Ms. Dreibelbis recommend a vaginal moisturizer especially formulated for vaginal tissue that can be absorbed by the mucosal tissue of the vagina. Use of this type of product can increase the effectiveness of lubricants and help restore integrity of the vaginal tissue. Such moisturizers are available as gels, creams, or suppositories over the counter, and do not contain hormones.
Vaginal estrogen can be helpful for burning, itching, irritation, tissue fragility, and pain with sex, according to Dr. Lersch and Ms. Dreibelbis. Adequate estrogen therapy can promote normalization of vaginal pH and microflora, as well increase vaginal secretion and reduce pain and dryness with intercourse, the presenters stated in their presentation. In addition, dilator therapy can be used to help prevent vaginal stenosis, and penetration bumpers can help relieve discomfort during intercourse, they wrote.
Looking ahead, more research is needed to serve a wider patient population, Ms. Dreibelbis said, in an interview.
“LGBTQIA [individuals] have not been included in sexual health research and there are more people than ever who identify within this group of people. I know there has also been some very early work on shielding the clitoris from the impacts of radiation, and I believe this is extremely important up-and-coming research,” she said.
Dr. Lersch, Ms. Dreibelbi, Dr. Dizon, Dr. Norquist, Ms. Brewer, and Dr. Mehta had no financial conflicts to disclose.
Decreased sexual function is a side effect of many types of cancer, notably uterine, cervical, ovarian, and breast cancer, that often goes unaddressed, according to the authors of several studies presented at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer.
Patients want to talk about sex, but not necessarily at the start of their diagnosis or treatment, suggest the findings of a study presented at the meeting. Jesse T. Brewer of Weill Cornell Medicine in New York City and colleagues enrolled 63 patients who underwent surgery with documented hereditary breast cancer, ovarian cancer, or Lynch syndrome in a cross-sectional survey.
Overall, 86% said that sexuality and intimacy were very or somewhat important, and 78% said that the healthcare team addressing the issue was very or somewhat important, the researchers found. However, only 40% of the respondents said that they wanted to discuss sexuality at the time of diagnosis because the idea was too overwhelming.
Oncologists are more aware of sexual side effects and the potential for sexual issues that persist long after treatment, but many patients may not have opportunities to talk about sexual concerns, said Don S. Dizon, MD, an oncologist specializing in women’s cancers at Brown University, Providence, Rhode Island, in an interview.
“It is important that we [oncologists] be the ones to open the door to these conversations; people with cancer will not bring it up spontaneously, for fear of making their provider uncomfortable, especially if they’ve never been asked about it before,” Dr. Dizon said in an interview.
He advised clinicians to find a network within their health systems so they can refer patients to specialized services, such as sex therapy, couples counseling, pelvic rehabilitation, or menopausal experts as needed.
In another study presented at the meeting, Naaman Mehta, MD, of NYU Langone Health, and colleagues reviewed data from 166 healthcare providers who completed a 23-item survey about evaluating and managing sexual health concerns of their patients. Most of the respondents were gynecologic oncologists (93.4%), but one radiation oncologist and 10 other healthcare providers also completed the survey.
Overall, approximately 60% of the respondents routinely asked about the sexual health concerns of their patients, and 98% of these said they believed that sexual health discussions should be held with a gynecologic oncologist. Just over half (54%) also said that the patient should be the one to initiate a discussion of sexual health concerns.
Female providers were significantly more likely to discuss sexual health with patients, compared with male providers, after controlling for the hospital setting and training level, the researchers noted (odds ratio, 1.4;P < .01).
The results suggest a need for more ways to integrate sexual health screening into gynecologic oncologic clinics, the researchers concluded.
The provider survey findings are similar to the results of a survey conducted by Dr. Dizon and colleagues in 2007. In that study, less than half of respondents took a sexual history, but 80% felt there was insufficient time to explore sexual issues.
“It is critical to understand that people with cancer do not expect their oncologists to be sexual health experts, but as with all other side effects caused by treatment and the diagnosis, we can be the ones who recognize it,” Dr. Dizon noted, in an interview.
Common Complaints and Causes
In Dr. Dizon’s experience, local symptoms including vaginal dryness, pain with penetration, and vaginal thinning, are common sexual complaints in women with cancer, as are systemic issues such as lack of interest and menopause-type symptoms.
“For those undergoing radiation, the vaginal tunnel can actually develop adhesions, and if not treated proactively this can lead to vaginal stenosis,” said Dr. Dizon, who was not involved in the studies presented at the meeting.
Comorbidities such as diabetes, cardiovascular disease, and musculoskeletal conditions can contribute to sexual issues in women with cancer, according to Nora Lersch, DNP, FNP-BC, AOCNP, and Nicole Dreibelbis, CRNP, the authors of other research presented at the meeting.
Culture, religion, fitness level, history of sexual violence, and gender spectrum health also play a role, as do anxiety and depression, dementia, and substance abuse disorders, the authors wrote in their presentation, “Prioritizing Sexual Health in Gynecological Oncology Care.”
Low libido is a frequent complaint across all cancer types, Ms. Dreibelbis, a nurse practitioner specializing in gynecologic oncology at the UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, said in an interview.
“Breast cancer patients, especially those on [aromatase inhibitor] therapy, often experience vaginal dryness and therefore dyspareunia,” she added.
The pelvic floor muscles, with their important role in sexual response, can be weakened by cancer treatment or surgery, and the pudendal nerves, which are the primary nerves responsible for sexual response in women, can be affected as well, Dr. Lersch and Ms. Dreibelbis wrote.
Taking Sex Seriously
Researchers are exploring the impact of different cancer prevention treatments for women to mitigate sexual side effects, as illustrated by another study presented at the meeting.
Dr. Barbara Norquist, MD, a gynecologic oncologist at the University of Washington, Seattle, and colleagues compared the sexual function and menopausal symptoms of patients at high risk of ovarian carcinoma who underwent either interval salpingectomy/delayed oophorectomy (ISDO) or risk-reducing salpingo-oophorectomy (RRSO).
“For patients at high risk for ovarian cancer, surgical removal of the tubes and ovaries is the mainstay of prevention, as screening is not effective at reducing death from ovarian cancer. As a result of surgery, many patients become suddenly postmenopausal from losing their ovaries,” Dr. Norquist said in an interview.
Some patients delay surgery out of concern for health and quality of life, including sexual function, she said.
In the study (known as the WISP trial) the researchers compared data from 166 patients who underwent immediate removal of the fallopian tubes and ovaries and 171 who underwent fallopian tube removal and delayed oophorectomy. All patients completed questionnaires about sexual function. The primary outcome was change in sexual function based on the sexual function index (FSFI) from baseline to 6 months after surgery.
Overall, changes in sexual function were significantly greater in the immediate oophorectomy group, compared with the delayed oophorectomy group at 6 months (33% vs 17%) and also at 12 months (43% vs 20%).
A further review of patients using hormone therapy showed that those in the immediate oophorectomy group still had greater decreases in sexual function, compared with the delayed group, though the difference between groups of patients using hormone therapy was less dramatic.
“I was surprised that, even with hormone replacement therapy, patients undergoing removal of the ovaries still had significant detrimental changes to sexual function when compared to those having the tubes removed, although this was even worse in those who could not take HRT,” Dr. Norquist said, in an interview. “I was reassured that menopausal symptoms in general were well managed with HRT, as these patients did not score differently on menopause symptoms, compared with those having their tubes removed,” she said.
Patients deserve accurate information about predicted changes in menopausal symptoms and sexual function as a result of ovary removal, and HRT should be provided when there is no contraindication, Dr. Norquist told this news organization.
Dr. Norquist and colleagues are awaiting the results of clinical trials investigating the safety of salpingectomy with delayed oophorectomy in terms of ovarian cancer prevention, but more research is needed to identify optimal management of the menopausal and sexual side effects associated with surgical menopause, she noted.
“Findings from the WISP study show the importance of hormones in women undergoing prophylactic surgery,” Dr. Dizon said. The findings indicate that salpingectomy has less of a negative influence on sexual function compared to removal of the ovaries, and the impact of hormone therapy and the relatively young age of the patients who took hormones reinforces current knowledge about hormones and sex, he added.
Barriers and Solutions
Barriers to asking women with cancer about sexual issues reported by providers include limited time, lack of training in sexual health, a desire to avoid offending the patient or making them uncomfortable, and uncertainty about how to answer the questions, Dr. Lersch and Ms. Dreibelbis wrote in their presentation.
Barriers to asking healthcare providers about their sexual issues reported by patients include the beliefs that the clinician should initiate the discussion, that sexual function will not be taken seriously, and that they might make the provider uncomfortable.
“Fortunately, more information and research has been done on sexual health and gynecological cancer in recent years, so oncologists are becoming more aware of the issues women may have,” said Dr. Lersch who is an oncology nurse practitioner at Providence Franz Cancer Institute in Portland, Oregon, in an interview.
Telling patients early in their cancer treatment about potential sexual side effects and opportunities for help is essential, she added.
Although oncologists have become more aware of the importance of sexual health and well-being for their patients, “I think there has historically been a disconnect in including sexual health education in medical training,” Ms. Dreibelbis said in an interview.
Dr. Lersch and Ms. Dreibelbis advised a multidimensional approach to managing sexual problems in cancer patients that includes consideration of biological and psychological symptoms, but also social, cultural, and interpersonal factors, in their presentation.
Their suggestions include discussing dyspareunia with their patients, asking for details such as whether the pain is internal or external, whether it occurs with activities outside of sex including masturbation, and whether bleeding is present.
Oncology therapies and surgeries can decrease or eliminate an individual’s ability to produce their own lubricant; for example, removal of the cervix eliminates cervical mucous, which helps with internal lubrication, they wrote in their presentation.
For patients with dyspareunia, Dr. Lersch and Ms. Dreibelbis recommend a vaginal moisturizer especially formulated for vaginal tissue that can be absorbed by the mucosal tissue of the vagina. Use of this type of product can increase the effectiveness of lubricants and help restore integrity of the vaginal tissue. Such moisturizers are available as gels, creams, or suppositories over the counter, and do not contain hormones.
Vaginal estrogen can be helpful for burning, itching, irritation, tissue fragility, and pain with sex, according to Dr. Lersch and Ms. Dreibelbis. Adequate estrogen therapy can promote normalization of vaginal pH and microflora, as well increase vaginal secretion and reduce pain and dryness with intercourse, the presenters stated in their presentation. In addition, dilator therapy can be used to help prevent vaginal stenosis, and penetration bumpers can help relieve discomfort during intercourse, they wrote.
Looking ahead, more research is needed to serve a wider patient population, Ms. Dreibelbis said, in an interview.
“LGBTQIA [individuals] have not been included in sexual health research and there are more people than ever who identify within this group of people. I know there has also been some very early work on shielding the clitoris from the impacts of radiation, and I believe this is extremely important up-and-coming research,” she said.
Dr. Lersch, Ms. Dreibelbi, Dr. Dizon, Dr. Norquist, Ms. Brewer, and Dr. Mehta had no financial conflicts to disclose.
FROM SGO 2024
What is the Best Approach to “Sinus Headaches”?
A 27-year-old woman presents requesting antibiotics for a sinus headache. She reports she has had 3-4 episodes a year with pain in her maxillary area and congestion. She has not had fevers with these episodes. She had the onset of this headache 6 hours ago. She has had resolution of the pain within 24 hours in the past with the use of antibiotics and decongestants. What would be the best treatment for her?
A. Amoxicillin
B. Amoxicillin/clavulanate
C. Amoxicillin + fluticasone nasal spray
D. Sumatriptan
The best treatment would be sumatriptan. This is very likely a variant of migraine headache and migraine-directed therapy is the best option. In regard to sinus headache, the International Headache Society (IHS) classification states that chronic sinusitis is not a cause of headache and facial pain unless it relapses into an acute sinusitis.1
The recurrent nature of the headaches in this patient suggests a primary headache disorder with migraine being the most likely. In a study of 2991 patients with self-diagnosed or physician-diagnosed “sinus headaches,” 88% of the patients met IHS criteria for migraine.2 In this study, most of the patients had symptoms suggesting sinus problems, with the most common symptoms being sinus pressure (84%), sinus pain (82%), and nasal congestion (63%). The likely cause for these symptoms in migraine patients is vasodilation of the nasal mucosa that can be part of the migraine event.
Foroughipour and colleagues found similar results.3 In their study, 58 patients with “sinus headache” were evaluated, with the final diagnosis of migraine in 40 patients (69%), tension-type headache in 16 patients (27%), and chronic sinusitis with recurrent acute episodes in 2 patients (3%). Recurrent antibiotic therapy had been given to 73% of the tension-type headache patients and 66% of the migraine patients.
Obermann et al. looked at how common trigeminal autonomic symptoms were in patients with migraine in a population-based study.4 They found of 841 patients who had migraine, 226 reported accompanying unilateral trigeminal autonomic symptoms (26.9%).
Al-Hashel et al. reported on how patients with frequent migraine are misdiagnosed and how long it takes when they present with sinus symptoms. A total of 130 migraine patients were recruited for the study; of these, 81.5% were misdiagnosed with sinusitis. The mean time delay of migraine diagnosis was almost 8 years.5
In a study by Dr. Elina Kari and Dr. John M. DelGaudio, patients who had a history of “sinus headaches” were treated as though all these headaches were migraines. Fifty-four patients were enrolled, and 38 patients completed the study. All patients had nasal endoscopy and sinus CT scans that were negative. They were then given migraine-directed treatment to use for their headaches. Of the 38 patient who completed the study, 31 patients (82%) had a significant reduction in headache pain with triptan use, and 35 patients (92%) had a significant response to migraine-directed therapy.6 An expert panel consisting of otolaryngologists, neurologists, allergists, and primary care physicians concluded that the majority of sinus headaches can actually be classified as migraines.7
These references aren’t new. This information has been known in the medical literature for more than 2 decades, but I believe that the majority of medical professionals are not aware of it. In my own practice I have found great success treating patients with sinus headache histories with migraine-directed therapy (mostly triptans) when they have return of their headaches.
Pearl: When your patients say they have another sinus headache, think migraine.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Jones NS. Expert Rev Neurother. 2009;9:439-44.
2. Schreiber CP et al. Arch Intern Med. 2004;164:1769-72.
3. Foroughipour M et al. Eur Arch Otorhinolaryngol. 2011;268:1593-6.
4. Obermann M et al. Cephalalgia. 2007 Jun;27(6):504-9.
5. Al-Hashel JY et al. J Headache Pain. 2013 Dec 12;14(1):97.
6. Kari E and DelGaudi JM. Laryngoscope. 2008;118:2235-9.
7. Levine HL et al. Otolaryngol Head Neck Surg. 2006 Mar;134(3):516-23.
A 27-year-old woman presents requesting antibiotics for a sinus headache. She reports she has had 3-4 episodes a year with pain in her maxillary area and congestion. She has not had fevers with these episodes. She had the onset of this headache 6 hours ago. She has had resolution of the pain within 24 hours in the past with the use of antibiotics and decongestants. What would be the best treatment for her?
A. Amoxicillin
B. Amoxicillin/clavulanate
C. Amoxicillin + fluticasone nasal spray
D. Sumatriptan
The best treatment would be sumatriptan. This is very likely a variant of migraine headache and migraine-directed therapy is the best option. In regard to sinus headache, the International Headache Society (IHS) classification states that chronic sinusitis is not a cause of headache and facial pain unless it relapses into an acute sinusitis.1
The recurrent nature of the headaches in this patient suggests a primary headache disorder with migraine being the most likely. In a study of 2991 patients with self-diagnosed or physician-diagnosed “sinus headaches,” 88% of the patients met IHS criteria for migraine.2 In this study, most of the patients had symptoms suggesting sinus problems, with the most common symptoms being sinus pressure (84%), sinus pain (82%), and nasal congestion (63%). The likely cause for these symptoms in migraine patients is vasodilation of the nasal mucosa that can be part of the migraine event.
Foroughipour and colleagues found similar results.3 In their study, 58 patients with “sinus headache” were evaluated, with the final diagnosis of migraine in 40 patients (69%), tension-type headache in 16 patients (27%), and chronic sinusitis with recurrent acute episodes in 2 patients (3%). Recurrent antibiotic therapy had been given to 73% of the tension-type headache patients and 66% of the migraine patients.
Obermann et al. looked at how common trigeminal autonomic symptoms were in patients with migraine in a population-based study.4 They found of 841 patients who had migraine, 226 reported accompanying unilateral trigeminal autonomic symptoms (26.9%).
Al-Hashel et al. reported on how patients with frequent migraine are misdiagnosed and how long it takes when they present with sinus symptoms. A total of 130 migraine patients were recruited for the study; of these, 81.5% were misdiagnosed with sinusitis. The mean time delay of migraine diagnosis was almost 8 years.5
In a study by Dr. Elina Kari and Dr. John M. DelGaudio, patients who had a history of “sinus headaches” were treated as though all these headaches were migraines. Fifty-four patients were enrolled, and 38 patients completed the study. All patients had nasal endoscopy and sinus CT scans that were negative. They were then given migraine-directed treatment to use for their headaches. Of the 38 patient who completed the study, 31 patients (82%) had a significant reduction in headache pain with triptan use, and 35 patients (92%) had a significant response to migraine-directed therapy.6 An expert panel consisting of otolaryngologists, neurologists, allergists, and primary care physicians concluded that the majority of sinus headaches can actually be classified as migraines.7
These references aren’t new. This information has been known in the medical literature for more than 2 decades, but I believe that the majority of medical professionals are not aware of it. In my own practice I have found great success treating patients with sinus headache histories with migraine-directed therapy (mostly triptans) when they have return of their headaches.
Pearl: When your patients say they have another sinus headache, think migraine.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Jones NS. Expert Rev Neurother. 2009;9:439-44.
2. Schreiber CP et al. Arch Intern Med. 2004;164:1769-72.
3. Foroughipour M et al. Eur Arch Otorhinolaryngol. 2011;268:1593-6.
4. Obermann M et al. Cephalalgia. 2007 Jun;27(6):504-9.
5. Al-Hashel JY et al. J Headache Pain. 2013 Dec 12;14(1):97.
6. Kari E and DelGaudi JM. Laryngoscope. 2008;118:2235-9.
7. Levine HL et al. Otolaryngol Head Neck Surg. 2006 Mar;134(3):516-23.
A 27-year-old woman presents requesting antibiotics for a sinus headache. She reports she has had 3-4 episodes a year with pain in her maxillary area and congestion. She has not had fevers with these episodes. She had the onset of this headache 6 hours ago. She has had resolution of the pain within 24 hours in the past with the use of antibiotics and decongestants. What would be the best treatment for her?
A. Amoxicillin
B. Amoxicillin/clavulanate
C. Amoxicillin + fluticasone nasal spray
D. Sumatriptan
The best treatment would be sumatriptan. This is very likely a variant of migraine headache and migraine-directed therapy is the best option. In regard to sinus headache, the International Headache Society (IHS) classification states that chronic sinusitis is not a cause of headache and facial pain unless it relapses into an acute sinusitis.1
The recurrent nature of the headaches in this patient suggests a primary headache disorder with migraine being the most likely. In a study of 2991 patients with self-diagnosed or physician-diagnosed “sinus headaches,” 88% of the patients met IHS criteria for migraine.2 In this study, most of the patients had symptoms suggesting sinus problems, with the most common symptoms being sinus pressure (84%), sinus pain (82%), and nasal congestion (63%). The likely cause for these symptoms in migraine patients is vasodilation of the nasal mucosa that can be part of the migraine event.
Foroughipour and colleagues found similar results.3 In their study, 58 patients with “sinus headache” were evaluated, with the final diagnosis of migraine in 40 patients (69%), tension-type headache in 16 patients (27%), and chronic sinusitis with recurrent acute episodes in 2 patients (3%). Recurrent antibiotic therapy had been given to 73% of the tension-type headache patients and 66% of the migraine patients.
Obermann et al. looked at how common trigeminal autonomic symptoms were in patients with migraine in a population-based study.4 They found of 841 patients who had migraine, 226 reported accompanying unilateral trigeminal autonomic symptoms (26.9%).
Al-Hashel et al. reported on how patients with frequent migraine are misdiagnosed and how long it takes when they present with sinus symptoms. A total of 130 migraine patients were recruited for the study; of these, 81.5% were misdiagnosed with sinusitis. The mean time delay of migraine diagnosis was almost 8 years.5
In a study by Dr. Elina Kari and Dr. John M. DelGaudio, patients who had a history of “sinus headaches” were treated as though all these headaches were migraines. Fifty-four patients were enrolled, and 38 patients completed the study. All patients had nasal endoscopy and sinus CT scans that were negative. They were then given migraine-directed treatment to use for their headaches. Of the 38 patient who completed the study, 31 patients (82%) had a significant reduction in headache pain with triptan use, and 35 patients (92%) had a significant response to migraine-directed therapy.6 An expert panel consisting of otolaryngologists, neurologists, allergists, and primary care physicians concluded that the majority of sinus headaches can actually be classified as migraines.7
These references aren’t new. This information has been known in the medical literature for more than 2 decades, but I believe that the majority of medical professionals are not aware of it. In my own practice I have found great success treating patients with sinus headache histories with migraine-directed therapy (mostly triptans) when they have return of their headaches.
Pearl: When your patients say they have another sinus headache, think migraine.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].
References
1. Jones NS. Expert Rev Neurother. 2009;9:439-44.
2. Schreiber CP et al. Arch Intern Med. 2004;164:1769-72.
3. Foroughipour M et al. Eur Arch Otorhinolaryngol. 2011;268:1593-6.
4. Obermann M et al. Cephalalgia. 2007 Jun;27(6):504-9.
5. Al-Hashel JY et al. J Headache Pain. 2013 Dec 12;14(1):97.
6. Kari E and DelGaudi JM. Laryngoscope. 2008;118:2235-9.
7. Levine HL et al. Otolaryngol Head Neck Surg. 2006 Mar;134(3):516-23.
PT Delivered Via Telemedicine Proves Noninferior to In-Person Care for Chronic Knee Pain
Physiotherapy conducted via video conference is noninferior to in-person sessions for the treatment of chronic knee pain, according to new research.
In the trial, participants assigned to in-person or telehealth sessions had similar improvements in knee pain and physical function over 3 months, while the online group had better session attendance and reported higher convenience.
While the COVID-19 pandemic increased the use of telerehabilitation physiotherapy services, it is not clear how these teleservices will be utilized moving forward, the study authors wrote. There is some research suggesting that both in-person and online physiotherapy are equally effective, but surveys suggest that both providers and patients remain unconvinced.
“Based on pandemic telerehabilitation experiences, less than half of allied health clinicians believe telerehabilitation is as effective as in-person care and almost half of patients think video conferencing with a physiotherapist provides lower quality care,” study first author Rana Hinman, PhD, professor of physiotherapy at the University of Melbourne, Australia, and colleagues wrote in their report published online in The Lancet.
‘A Game Changer’ for Physical Therapy
Commenting on the study for this news organization, Daniel White, ScD, an associate professor in the department of physical therapy at the University of Delaware in Newark, Delaware, called the research “a game changer” for physical therapy.
“It’s showing that in-person care can be replicated in terms of efficacy,” in telehealth settings, he said. “From a telehealth perspective, it really opens the doors to access to people who have difficulty reaching physical therapists,” he added, “and puts us on stage with other modes of telehealth that are given as part of modern medicine.”
Dr. White noted that physical therapy treatment for knee osteoarthritis is underused, with just 10% of patients seeing a physical therapist prior to undergoing knee replacement. While knee replacements are effective interventions, he said, access to physical therapy could allow many patients to put off having surgery.
The findings not only provide solutions for access issues but also assuage concerns “that you’re going to get ‘physical therapy lite’” with telehealth, Dr. White added.
“You can deliver physical therapy to this group that typically is not getting enough of it,” he said, “and it is just as effective when delivered online than if it were to be delivered in person.”
Noninferiority Maintained at 9 Months’ Follow-up
To understand how video conferencing physiotherapy consultations compared to in-person care, the researchers designed a non-inferiority randomized controlled trial.
For the trial, researchers enrolled 394 adults with chronic knee pain who were aged ≥ 45 years, had activity-related joint pain, and either had no morning stiffness or morning stiffness lasting < 30 minutes. Other inclusion criteria were history of knee pain of ≥ 3 months, knee pain most days of the previous month, average walking pain score of four or more on the 11-point numeric rating scale (NRS) over the previous week, and difficulty walking and climbing stairs.
Participants also needed access to a computer device with internet as well as the ability to travel to the nearest trial physiotherapist.
The study recruited 15 physiotherapists across 27 practices in metropolitan Queensland and Victoria, Australia, of which 60% had no previous telerehabilitation experience. Physiotherapists were trained to conduct video sessions via e-learning, practice video consultations, and a competency video conferencing evaluation.
Participants were randomly assigned to in-person or video physiotherapist consultations, with both groups receiving five consultations over 3 months. All clients were prescribed a home-based strength training program and physical activity plan.
The primary outcomes were changes at 3 months in patient-reported knee pain (on a scale of 0-10), with an inferiority margin of 0.95, and physical function — assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) — with an inferiority margin of −5.44.
From December 10, 2019, to June 17, 2022, 204 participants were assigned to in-person sessions and 190 were assigned to telerehabilitation. At 3 months, both groups reported improved pain and physical function, with no significant differences between the two groups with either measure. The mean between-group difference was 0.16 (95% CI, −0.26 to 0.57) for knee pain and 1.65 (−0.23 to 3.53) for physical function. Noninferiority was also maintained at 9 months’ follow-up.
The trial took place over the COVID-19 pandemic, which limited participant ability to attend in-person consultations. In total, 84% of participants assigned to in-person rehabilitation attended at least three or more consultations compared with 96% of those assigned to telerehabilitation. In an additional analysis including only participants attending three or more sessions, improvement in knee pain and physical function was similar between the in-person or tele-rehabilitation groups “showing that the findings are robust,” the authors noted.
At 3 months, the telerehabilitation group ranked their sessions as more convenient that their in-person counterparts and reported greater adherence to their strengthening program. At 9 months’ follow-up, the telerehabilitation group had higher physical activity scores than the in-person group.
This research was funded by the Australian National Health and Medical Research Council. Two authors reported grant funding paid to the University of Melbourne from the National Health & Medical Research Council, Australian Research Council, Medical Research Future Fund, and Medibank for research. Dr. White has been a paid speaker for Viatris.
A version of this article appeared on Medscape.com.
Physiotherapy conducted via video conference is noninferior to in-person sessions for the treatment of chronic knee pain, according to new research.
In the trial, participants assigned to in-person or telehealth sessions had similar improvements in knee pain and physical function over 3 months, while the online group had better session attendance and reported higher convenience.
While the COVID-19 pandemic increased the use of telerehabilitation physiotherapy services, it is not clear how these teleservices will be utilized moving forward, the study authors wrote. There is some research suggesting that both in-person and online physiotherapy are equally effective, but surveys suggest that both providers and patients remain unconvinced.
“Based on pandemic telerehabilitation experiences, less than half of allied health clinicians believe telerehabilitation is as effective as in-person care and almost half of patients think video conferencing with a physiotherapist provides lower quality care,” study first author Rana Hinman, PhD, professor of physiotherapy at the University of Melbourne, Australia, and colleagues wrote in their report published online in The Lancet.
‘A Game Changer’ for Physical Therapy
Commenting on the study for this news organization, Daniel White, ScD, an associate professor in the department of physical therapy at the University of Delaware in Newark, Delaware, called the research “a game changer” for physical therapy.
“It’s showing that in-person care can be replicated in terms of efficacy,” in telehealth settings, he said. “From a telehealth perspective, it really opens the doors to access to people who have difficulty reaching physical therapists,” he added, “and puts us on stage with other modes of telehealth that are given as part of modern medicine.”
Dr. White noted that physical therapy treatment for knee osteoarthritis is underused, with just 10% of patients seeing a physical therapist prior to undergoing knee replacement. While knee replacements are effective interventions, he said, access to physical therapy could allow many patients to put off having surgery.
The findings not only provide solutions for access issues but also assuage concerns “that you’re going to get ‘physical therapy lite’” with telehealth, Dr. White added.
“You can deliver physical therapy to this group that typically is not getting enough of it,” he said, “and it is just as effective when delivered online than if it were to be delivered in person.”
Noninferiority Maintained at 9 Months’ Follow-up
To understand how video conferencing physiotherapy consultations compared to in-person care, the researchers designed a non-inferiority randomized controlled trial.
For the trial, researchers enrolled 394 adults with chronic knee pain who were aged ≥ 45 years, had activity-related joint pain, and either had no morning stiffness or morning stiffness lasting < 30 minutes. Other inclusion criteria were history of knee pain of ≥ 3 months, knee pain most days of the previous month, average walking pain score of four or more on the 11-point numeric rating scale (NRS) over the previous week, and difficulty walking and climbing stairs.
Participants also needed access to a computer device with internet as well as the ability to travel to the nearest trial physiotherapist.
The study recruited 15 physiotherapists across 27 practices in metropolitan Queensland and Victoria, Australia, of which 60% had no previous telerehabilitation experience. Physiotherapists were trained to conduct video sessions via e-learning, practice video consultations, and a competency video conferencing evaluation.
Participants were randomly assigned to in-person or video physiotherapist consultations, with both groups receiving five consultations over 3 months. All clients were prescribed a home-based strength training program and physical activity plan.
The primary outcomes were changes at 3 months in patient-reported knee pain (on a scale of 0-10), with an inferiority margin of 0.95, and physical function — assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) — with an inferiority margin of −5.44.
From December 10, 2019, to June 17, 2022, 204 participants were assigned to in-person sessions and 190 were assigned to telerehabilitation. At 3 months, both groups reported improved pain and physical function, with no significant differences between the two groups with either measure. The mean between-group difference was 0.16 (95% CI, −0.26 to 0.57) for knee pain and 1.65 (−0.23 to 3.53) for physical function. Noninferiority was also maintained at 9 months’ follow-up.
The trial took place over the COVID-19 pandemic, which limited participant ability to attend in-person consultations. In total, 84% of participants assigned to in-person rehabilitation attended at least three or more consultations compared with 96% of those assigned to telerehabilitation. In an additional analysis including only participants attending three or more sessions, improvement in knee pain and physical function was similar between the in-person or tele-rehabilitation groups “showing that the findings are robust,” the authors noted.
At 3 months, the telerehabilitation group ranked their sessions as more convenient that their in-person counterparts and reported greater adherence to their strengthening program. At 9 months’ follow-up, the telerehabilitation group had higher physical activity scores than the in-person group.
This research was funded by the Australian National Health and Medical Research Council. Two authors reported grant funding paid to the University of Melbourne from the National Health & Medical Research Council, Australian Research Council, Medical Research Future Fund, and Medibank for research. Dr. White has been a paid speaker for Viatris.
A version of this article appeared on Medscape.com.
Physiotherapy conducted via video conference is noninferior to in-person sessions for the treatment of chronic knee pain, according to new research.
In the trial, participants assigned to in-person or telehealth sessions had similar improvements in knee pain and physical function over 3 months, while the online group had better session attendance and reported higher convenience.
While the COVID-19 pandemic increased the use of telerehabilitation physiotherapy services, it is not clear how these teleservices will be utilized moving forward, the study authors wrote. There is some research suggesting that both in-person and online physiotherapy are equally effective, but surveys suggest that both providers and patients remain unconvinced.
“Based on pandemic telerehabilitation experiences, less than half of allied health clinicians believe telerehabilitation is as effective as in-person care and almost half of patients think video conferencing with a physiotherapist provides lower quality care,” study first author Rana Hinman, PhD, professor of physiotherapy at the University of Melbourne, Australia, and colleagues wrote in their report published online in The Lancet.
‘A Game Changer’ for Physical Therapy
Commenting on the study for this news organization, Daniel White, ScD, an associate professor in the department of physical therapy at the University of Delaware in Newark, Delaware, called the research “a game changer” for physical therapy.
“It’s showing that in-person care can be replicated in terms of efficacy,” in telehealth settings, he said. “From a telehealth perspective, it really opens the doors to access to people who have difficulty reaching physical therapists,” he added, “and puts us on stage with other modes of telehealth that are given as part of modern medicine.”
Dr. White noted that physical therapy treatment for knee osteoarthritis is underused, with just 10% of patients seeing a physical therapist prior to undergoing knee replacement. While knee replacements are effective interventions, he said, access to physical therapy could allow many patients to put off having surgery.
The findings not only provide solutions for access issues but also assuage concerns “that you’re going to get ‘physical therapy lite’” with telehealth, Dr. White added.
“You can deliver physical therapy to this group that typically is not getting enough of it,” he said, “and it is just as effective when delivered online than if it were to be delivered in person.”
Noninferiority Maintained at 9 Months’ Follow-up
To understand how video conferencing physiotherapy consultations compared to in-person care, the researchers designed a non-inferiority randomized controlled trial.
For the trial, researchers enrolled 394 adults with chronic knee pain who were aged ≥ 45 years, had activity-related joint pain, and either had no morning stiffness or morning stiffness lasting < 30 minutes. Other inclusion criteria were history of knee pain of ≥ 3 months, knee pain most days of the previous month, average walking pain score of four or more on the 11-point numeric rating scale (NRS) over the previous week, and difficulty walking and climbing stairs.
Participants also needed access to a computer device with internet as well as the ability to travel to the nearest trial physiotherapist.
The study recruited 15 physiotherapists across 27 practices in metropolitan Queensland and Victoria, Australia, of which 60% had no previous telerehabilitation experience. Physiotherapists were trained to conduct video sessions via e-learning, practice video consultations, and a competency video conferencing evaluation.
Participants were randomly assigned to in-person or video physiotherapist consultations, with both groups receiving five consultations over 3 months. All clients were prescribed a home-based strength training program and physical activity plan.
The primary outcomes were changes at 3 months in patient-reported knee pain (on a scale of 0-10), with an inferiority margin of 0.95, and physical function — assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) — with an inferiority margin of −5.44.
From December 10, 2019, to June 17, 2022, 204 participants were assigned to in-person sessions and 190 were assigned to telerehabilitation. At 3 months, both groups reported improved pain and physical function, with no significant differences between the two groups with either measure. The mean between-group difference was 0.16 (95% CI, −0.26 to 0.57) for knee pain and 1.65 (−0.23 to 3.53) for physical function. Noninferiority was also maintained at 9 months’ follow-up.
The trial took place over the COVID-19 pandemic, which limited participant ability to attend in-person consultations. In total, 84% of participants assigned to in-person rehabilitation attended at least three or more consultations compared with 96% of those assigned to telerehabilitation. In an additional analysis including only participants attending three or more sessions, improvement in knee pain and physical function was similar between the in-person or tele-rehabilitation groups “showing that the findings are robust,” the authors noted.
At 3 months, the telerehabilitation group ranked their sessions as more convenient that their in-person counterparts and reported greater adherence to their strengthening program. At 9 months’ follow-up, the telerehabilitation group had higher physical activity scores than the in-person group.
This research was funded by the Australian National Health and Medical Research Council. Two authors reported grant funding paid to the University of Melbourne from the National Health & Medical Research Council, Australian Research Council, Medical Research Future Fund, and Medibank for research. Dr. White has been a paid speaker for Viatris.
A version of this article appeared on Medscape.com.
FROM THE LANCET
Many Older Adults Don’t Receive Palliative Care Before Death
A prognostic tool may facilitate the early identification of older adults in the community who would benefit from palliative care in their final years, new research from Canada suggested.
The analysis of data from close to a quarter million community-dwelling older adults in Ontario with at least one interRAI (Resident Assessment Instrument) home care assessment showed that only half of those with an estimated survival of fewer than 3 months received at least one palliative home care visit before death.
“One of the challenges and a barrier to accessing palliative home care is the difficulty of predicting survival,” Amy Hsu, PhD, an investigator at the Bruyère Research Institute in Ottawa, Ontario, Canada, told this news organization. “Clinicians are good at prognosticating when a patient might be entering their last 3-6 weeks of life, but they have a harder time predicting if someone will survive 6 months or longer.”
The team developed the Risk Evaluation for Support: Predictions for Elder-life in their Communities Tool (RESPECT) to see whether access to predicted survival data could inform conversations about a patient’s status and palliative care needs.
The study was published online in the Canadian Medical Association Journal.
Setting Care Goals
Researchers analyzed population health administrative data from Ontario involving home care clients who received at least one interRAI Home Care assessment between April 2018 and September 2019. The cohort included 247,377 adults (62% women) with a mean age of 80.1 years at the time of assessment. Comorbidities, including congestive heart failure, coronary artery disease, cancer, and chronic obstructive pulmonary disease, as well as symptoms of health instability, were more prevalent among those at higher risk of dying.
The team used an updated, validated version of RESPECT to predict survival.
Only 2.6% of home care clients had received a clinician diagnosis of an end-stage disease, which was more prevalent among those at highest mortality risk (77.9%). Most clients (74.5%) required extensive assistance in performing instrumental activities of daily living (ADLs, score ≤ 4), and half (50.3%) were less able to perform ADLs in the last 3 months of life.
Within the cohort, 75% of patients with a predicted median survival of fewer than 3 months, 55.4% of those with a predicted median survival between 3 and 6 months, and 40.7% of those with a predicted median survival between 6 and 12 months died within 6 months of the home care assessment.
Among decedents, 50.6% of those with a RESPECT-estimated median survival of fewer than 3 months received at least one nonphysician palliative home care visit before death. Less than a third (27.8%) received at least one palliative home care visit from a physician.
The proportion of those who received at least one nonphysician visit fell to 38.7% among those with a median survival of between 3 and 6 months and to 29.5% among those with a median survival of between 6 and 12 months.
Patients who received at least one palliative home care visit (from either physicians or nonphysician home care providers) within 6 months of an assessment had clinical characteristics similar to those who did not receive a visit. However, those who did not receive palliative home care were more likely to not have been identified by a clinician as being in their past 6 months of life.
“These results reinforce the role of clinicians in identifying older adults who may be in their last 6 months of life as an important component for the receipt of palliative home care and highlight the value of RESPECT in supplementing clinicians’ assessments of prognosis,” the authors wrote.
“Our goal is to use data and tools like RESPECT to help individuals living with a life-limiting illness have conversations about what their end-of-life care goals and wishes may be and discuss whether a referral to palliative care is appropriate or needed,” Dr. Hsu added. “Data about life expectancy could be helpful for framing these conversations.”
The researchers are working with partners in home, community care, and long-term care to implement RESPECT in their settings.
‘Valuable Tool’
Guohua Li, MD, DrPH, professor of epidemiology and anesthesiology at Columbia University Mailman School of Public Health and Vagelos College of Physicians and Surgeons in New York City, commented on the findings for this news organization. He noted that the study is “rigorously designed and meticulously analyzed. The findings are of high validity and population health significance.”
The findings are comparable with what is seen in the United States and Canada, he said, where about 50% of terminally ill patients die at home or in hospice. However, palliative care outside of North America “varies greatly, and in many developing countries, [it] is still in its infancy.”
As a mortality risk prediction algorithm, “RESPECT seems to perform reasonably well,” he said. “If incorporated into the electronic health record, it could be a valuable tool for clinicians to identify patients with less than 6 months of life expectancy and deliver palliative care to these patients. RESPECT appears to be particularly beneficial for home care patients without a clinically diagnosed terminal disease.”
That said, he added, “RESPECT should be viewed as a clinical decision support tool. It is no substitute for clinicians or clinical judgment. Based on the data presented in the paper, the algorithm tends to overestimate the short-term mortality risk for home care patients, therefore resulting in many false alarms.”
The study was supported by the Canadian Institutes of Health Research and the Associated Medical Services. Dr. Hsu is an executive lead on the steering committee of the Ontario Centres for Learning, Research, and Innovation in Long-Term Care. Funding for the centers comes from the Ontario Ministry of Health and Ministry of Long-Term Care and is partially administered by the Bruyère Research Institute. Dr. Li reported no relevant financial interests.
A version of this article appeared on Medscape.com.
A prognostic tool may facilitate the early identification of older adults in the community who would benefit from palliative care in their final years, new research from Canada suggested.
The analysis of data from close to a quarter million community-dwelling older adults in Ontario with at least one interRAI (Resident Assessment Instrument) home care assessment showed that only half of those with an estimated survival of fewer than 3 months received at least one palliative home care visit before death.
“One of the challenges and a barrier to accessing palliative home care is the difficulty of predicting survival,” Amy Hsu, PhD, an investigator at the Bruyère Research Institute in Ottawa, Ontario, Canada, told this news organization. “Clinicians are good at prognosticating when a patient might be entering their last 3-6 weeks of life, but they have a harder time predicting if someone will survive 6 months or longer.”
The team developed the Risk Evaluation for Support: Predictions for Elder-life in their Communities Tool (RESPECT) to see whether access to predicted survival data could inform conversations about a patient’s status and palliative care needs.
The study was published online in the Canadian Medical Association Journal.
Setting Care Goals
Researchers analyzed population health administrative data from Ontario involving home care clients who received at least one interRAI Home Care assessment between April 2018 and September 2019. The cohort included 247,377 adults (62% women) with a mean age of 80.1 years at the time of assessment. Comorbidities, including congestive heart failure, coronary artery disease, cancer, and chronic obstructive pulmonary disease, as well as symptoms of health instability, were more prevalent among those at higher risk of dying.
The team used an updated, validated version of RESPECT to predict survival.
Only 2.6% of home care clients had received a clinician diagnosis of an end-stage disease, which was more prevalent among those at highest mortality risk (77.9%). Most clients (74.5%) required extensive assistance in performing instrumental activities of daily living (ADLs, score ≤ 4), and half (50.3%) were less able to perform ADLs in the last 3 months of life.
Within the cohort, 75% of patients with a predicted median survival of fewer than 3 months, 55.4% of those with a predicted median survival between 3 and 6 months, and 40.7% of those with a predicted median survival between 6 and 12 months died within 6 months of the home care assessment.
Among decedents, 50.6% of those with a RESPECT-estimated median survival of fewer than 3 months received at least one nonphysician palliative home care visit before death. Less than a third (27.8%) received at least one palliative home care visit from a physician.
The proportion of those who received at least one nonphysician visit fell to 38.7% among those with a median survival of between 3 and 6 months and to 29.5% among those with a median survival of between 6 and 12 months.
Patients who received at least one palliative home care visit (from either physicians or nonphysician home care providers) within 6 months of an assessment had clinical characteristics similar to those who did not receive a visit. However, those who did not receive palliative home care were more likely to not have been identified by a clinician as being in their past 6 months of life.
“These results reinforce the role of clinicians in identifying older adults who may be in their last 6 months of life as an important component for the receipt of palliative home care and highlight the value of RESPECT in supplementing clinicians’ assessments of prognosis,” the authors wrote.
“Our goal is to use data and tools like RESPECT to help individuals living with a life-limiting illness have conversations about what their end-of-life care goals and wishes may be and discuss whether a referral to palliative care is appropriate or needed,” Dr. Hsu added. “Data about life expectancy could be helpful for framing these conversations.”
The researchers are working with partners in home, community care, and long-term care to implement RESPECT in their settings.
‘Valuable Tool’
Guohua Li, MD, DrPH, professor of epidemiology and anesthesiology at Columbia University Mailman School of Public Health and Vagelos College of Physicians and Surgeons in New York City, commented on the findings for this news organization. He noted that the study is “rigorously designed and meticulously analyzed. The findings are of high validity and population health significance.”
The findings are comparable with what is seen in the United States and Canada, he said, where about 50% of terminally ill patients die at home or in hospice. However, palliative care outside of North America “varies greatly, and in many developing countries, [it] is still in its infancy.”
As a mortality risk prediction algorithm, “RESPECT seems to perform reasonably well,” he said. “If incorporated into the electronic health record, it could be a valuable tool for clinicians to identify patients with less than 6 months of life expectancy and deliver palliative care to these patients. RESPECT appears to be particularly beneficial for home care patients without a clinically diagnosed terminal disease.”
That said, he added, “RESPECT should be viewed as a clinical decision support tool. It is no substitute for clinicians or clinical judgment. Based on the data presented in the paper, the algorithm tends to overestimate the short-term mortality risk for home care patients, therefore resulting in many false alarms.”
The study was supported by the Canadian Institutes of Health Research and the Associated Medical Services. Dr. Hsu is an executive lead on the steering committee of the Ontario Centres for Learning, Research, and Innovation in Long-Term Care. Funding for the centers comes from the Ontario Ministry of Health and Ministry of Long-Term Care and is partially administered by the Bruyère Research Institute. Dr. Li reported no relevant financial interests.
A version of this article appeared on Medscape.com.
A prognostic tool may facilitate the early identification of older adults in the community who would benefit from palliative care in their final years, new research from Canada suggested.
The analysis of data from close to a quarter million community-dwelling older adults in Ontario with at least one interRAI (Resident Assessment Instrument) home care assessment showed that only half of those with an estimated survival of fewer than 3 months received at least one palliative home care visit before death.
“One of the challenges and a barrier to accessing palliative home care is the difficulty of predicting survival,” Amy Hsu, PhD, an investigator at the Bruyère Research Institute in Ottawa, Ontario, Canada, told this news organization. “Clinicians are good at prognosticating when a patient might be entering their last 3-6 weeks of life, but they have a harder time predicting if someone will survive 6 months or longer.”
The team developed the Risk Evaluation for Support: Predictions for Elder-life in their Communities Tool (RESPECT) to see whether access to predicted survival data could inform conversations about a patient’s status and palliative care needs.
The study was published online in the Canadian Medical Association Journal.
Setting Care Goals
Researchers analyzed population health administrative data from Ontario involving home care clients who received at least one interRAI Home Care assessment between April 2018 and September 2019. The cohort included 247,377 adults (62% women) with a mean age of 80.1 years at the time of assessment. Comorbidities, including congestive heart failure, coronary artery disease, cancer, and chronic obstructive pulmonary disease, as well as symptoms of health instability, were more prevalent among those at higher risk of dying.
The team used an updated, validated version of RESPECT to predict survival.
Only 2.6% of home care clients had received a clinician diagnosis of an end-stage disease, which was more prevalent among those at highest mortality risk (77.9%). Most clients (74.5%) required extensive assistance in performing instrumental activities of daily living (ADLs, score ≤ 4), and half (50.3%) were less able to perform ADLs in the last 3 months of life.
Within the cohort, 75% of patients with a predicted median survival of fewer than 3 months, 55.4% of those with a predicted median survival between 3 and 6 months, and 40.7% of those with a predicted median survival between 6 and 12 months died within 6 months of the home care assessment.
Among decedents, 50.6% of those with a RESPECT-estimated median survival of fewer than 3 months received at least one nonphysician palliative home care visit before death. Less than a third (27.8%) received at least one palliative home care visit from a physician.
The proportion of those who received at least one nonphysician visit fell to 38.7% among those with a median survival of between 3 and 6 months and to 29.5% among those with a median survival of between 6 and 12 months.
Patients who received at least one palliative home care visit (from either physicians or nonphysician home care providers) within 6 months of an assessment had clinical characteristics similar to those who did not receive a visit. However, those who did not receive palliative home care were more likely to not have been identified by a clinician as being in their past 6 months of life.
“These results reinforce the role of clinicians in identifying older adults who may be in their last 6 months of life as an important component for the receipt of palliative home care and highlight the value of RESPECT in supplementing clinicians’ assessments of prognosis,” the authors wrote.
“Our goal is to use data and tools like RESPECT to help individuals living with a life-limiting illness have conversations about what their end-of-life care goals and wishes may be and discuss whether a referral to palliative care is appropriate or needed,” Dr. Hsu added. “Data about life expectancy could be helpful for framing these conversations.”
The researchers are working with partners in home, community care, and long-term care to implement RESPECT in their settings.
‘Valuable Tool’
Guohua Li, MD, DrPH, professor of epidemiology and anesthesiology at Columbia University Mailman School of Public Health and Vagelos College of Physicians and Surgeons in New York City, commented on the findings for this news organization. He noted that the study is “rigorously designed and meticulously analyzed. The findings are of high validity and population health significance.”
The findings are comparable with what is seen in the United States and Canada, he said, where about 50% of terminally ill patients die at home or in hospice. However, palliative care outside of North America “varies greatly, and in many developing countries, [it] is still in its infancy.”
As a mortality risk prediction algorithm, “RESPECT seems to perform reasonably well,” he said. “If incorporated into the electronic health record, it could be a valuable tool for clinicians to identify patients with less than 6 months of life expectancy and deliver palliative care to these patients. RESPECT appears to be particularly beneficial for home care patients without a clinically diagnosed terminal disease.”
That said, he added, “RESPECT should be viewed as a clinical decision support tool. It is no substitute for clinicians or clinical judgment. Based on the data presented in the paper, the algorithm tends to overestimate the short-term mortality risk for home care patients, therefore resulting in many false alarms.”
The study was supported by the Canadian Institutes of Health Research and the Associated Medical Services. Dr. Hsu is an executive lead on the steering committee of the Ontario Centres for Learning, Research, and Innovation in Long-Term Care. Funding for the centers comes from the Ontario Ministry of Health and Ministry of Long-Term Care and is partially administered by the Bruyère Research Institute. Dr. Li reported no relevant financial interests.
A version of this article appeared on Medscape.com.
FROM THE CANADIAN MEDICAL ASSOCIATION JOURNAL