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‘Landmark’ trial shows opioids for back, neck pain no better than placebo
Opioids do not relieve acute low back or neck pain in the short term and lead to worse outcomes in the long term, results of the first randomized controlled trial testing the efficacy and safety of a short course of opioids for acute nonspecific low back/neck pain suggest.
After 6 weeks, there was no significant difference in pain scores of patients who took opioids, compared with those who took placebo. After 1 year, patients given the placebo had slightly lower pain scores. Also, patients using opioids were at greater risk of opioid misuse after 1 year.
This is a “landmark” trial with “practice-changing” results, senior author Christine Lin, PhD, with the University of Sydney, told this news organization.
“Before this trial, we did not have good evidence on whether opioids were effective for acute low back pain or neck pain, yet opioids were one of the most commonly used medicines for these conditions,” Dr. Lin explained.
On the basis of these results, “opioids should not be recommended at all for acute low back pain and neck pain,” Dr. Lin said.
Results of the OPAL study were published online in The Lancet.
Rigorous trial
The trial was conducted in 157 primary care or emergency department sites in Australia and involved 347 adults who had been experiencing low back pain, neck pain, or both for 12 weeks or less.
They were randomly allocated (1:1) to receive guideline-recommended care (reassurance and advice to stay active) plus an opioid (oxycodone up to 20 mg daily) or identical placebo for up to 6 weeks. Naloxone was provided to help prevent opioid-induced constipation and improve blinding.
The primary outcome was pain severity at 6 weeks, measured with the pain severity subscale of the Brief Pain Inventory (10-point scale).
After 6 weeks, opioid therapy offered no more relief for acute back/neck pain or functional improvement than placebo.
The mean pain score at 6 weeks was 2.78 in the opioid group, versus 2.25 in the placebo group (adjusted mean difference, 0.53; 95% confidence interval, –0.00 to 1.07; P = .051). At 1 year, mean pain scores in the placebo group were slightly lower than in the opioid group (1.8 vs. 2.4).
In addition, there was a doubling of the risk of opioid misuse at 1 year among patients randomly allocated to receive opioid therapy for 6 weeks, compared with those allocated to receive placebo for 6 weeks.
At 1 year, 24 (20%) of 123 of the patients who received opioids were at risk of misuse, as indicated by the Current Opioid Misuse Measure scale, compared with 13 (10%) of 128 patients in the placebo group (P = .049). The COMM is a widely used measure of current aberrant drug-related behavior among patients with chronic pain who are being prescribed opioid therapy.
Results raise ‘serious questions’
“I believe the findings of the study will need to be disseminated to the doctors and patients, so they receive this latest evidence on opioids,” Dr. Lin said in an interview.
“We need to reassure doctors and patients that most people with acute low back pain and neck pain recover well with time (usually by 6 weeks), so management is simple – staying active, avoiding bed rest, and, if necessary, using a heat pack for short term pain relief. If drugs are required, consider anti-inflammatory drugs,” Dr. Lin added.
The authors of a linked comment say the OPAL trial “raises serious questions about the use of opioid therapy for acute low back and neck pain.”
Mark Sullivan, MD, PhD, and Jane Ballantyne, MD, with the University of Washington, Seattle, note that current clinical guidelines recommend opioids for patients with acute back and neck pain when other drug treatments fail or are contraindicated.
“As many as two-thirds of patients might receive an opioid when presenting for care of back or neck pain. It is time to re-examine these guidelines and these practices,” Dr. Sullivan and Dr. Ballantyne conclude.
Funding for the OPAL study was provided by the National Health and Medical Research Council, the University of Sydney Faculty of Medicine and Health, and SafeWork SA. The study authors have disclosed no relevant financial relationships. Dr. Sullivan and Dr. Ballantyne are board members (unpaid) of Physicians for Responsible Opioid Prescribing and have been paid consultants in opioid litigation.
A version of this article originally appeared on Medscape.com.
Opioids do not relieve acute low back or neck pain in the short term and lead to worse outcomes in the long term, results of the first randomized controlled trial testing the efficacy and safety of a short course of opioids for acute nonspecific low back/neck pain suggest.
After 6 weeks, there was no significant difference in pain scores of patients who took opioids, compared with those who took placebo. After 1 year, patients given the placebo had slightly lower pain scores. Also, patients using opioids were at greater risk of opioid misuse after 1 year.
This is a “landmark” trial with “practice-changing” results, senior author Christine Lin, PhD, with the University of Sydney, told this news organization.
“Before this trial, we did not have good evidence on whether opioids were effective for acute low back pain or neck pain, yet opioids were one of the most commonly used medicines for these conditions,” Dr. Lin explained.
On the basis of these results, “opioids should not be recommended at all for acute low back pain and neck pain,” Dr. Lin said.
Results of the OPAL study were published online in The Lancet.
Rigorous trial
The trial was conducted in 157 primary care or emergency department sites in Australia and involved 347 adults who had been experiencing low back pain, neck pain, or both for 12 weeks or less.
They were randomly allocated (1:1) to receive guideline-recommended care (reassurance and advice to stay active) plus an opioid (oxycodone up to 20 mg daily) or identical placebo for up to 6 weeks. Naloxone was provided to help prevent opioid-induced constipation and improve blinding.
The primary outcome was pain severity at 6 weeks, measured with the pain severity subscale of the Brief Pain Inventory (10-point scale).
After 6 weeks, opioid therapy offered no more relief for acute back/neck pain or functional improvement than placebo.
The mean pain score at 6 weeks was 2.78 in the opioid group, versus 2.25 in the placebo group (adjusted mean difference, 0.53; 95% confidence interval, –0.00 to 1.07; P = .051). At 1 year, mean pain scores in the placebo group were slightly lower than in the opioid group (1.8 vs. 2.4).
In addition, there was a doubling of the risk of opioid misuse at 1 year among patients randomly allocated to receive opioid therapy for 6 weeks, compared with those allocated to receive placebo for 6 weeks.
At 1 year, 24 (20%) of 123 of the patients who received opioids were at risk of misuse, as indicated by the Current Opioid Misuse Measure scale, compared with 13 (10%) of 128 patients in the placebo group (P = .049). The COMM is a widely used measure of current aberrant drug-related behavior among patients with chronic pain who are being prescribed opioid therapy.
Results raise ‘serious questions’
“I believe the findings of the study will need to be disseminated to the doctors and patients, so they receive this latest evidence on opioids,” Dr. Lin said in an interview.
“We need to reassure doctors and patients that most people with acute low back pain and neck pain recover well with time (usually by 6 weeks), so management is simple – staying active, avoiding bed rest, and, if necessary, using a heat pack for short term pain relief. If drugs are required, consider anti-inflammatory drugs,” Dr. Lin added.
The authors of a linked comment say the OPAL trial “raises serious questions about the use of opioid therapy for acute low back and neck pain.”
Mark Sullivan, MD, PhD, and Jane Ballantyne, MD, with the University of Washington, Seattle, note that current clinical guidelines recommend opioids for patients with acute back and neck pain when other drug treatments fail or are contraindicated.
“As many as two-thirds of patients might receive an opioid when presenting for care of back or neck pain. It is time to re-examine these guidelines and these practices,” Dr. Sullivan and Dr. Ballantyne conclude.
Funding for the OPAL study was provided by the National Health and Medical Research Council, the University of Sydney Faculty of Medicine and Health, and SafeWork SA. The study authors have disclosed no relevant financial relationships. Dr. Sullivan and Dr. Ballantyne are board members (unpaid) of Physicians for Responsible Opioid Prescribing and have been paid consultants in opioid litigation.
A version of this article originally appeared on Medscape.com.
Opioids do not relieve acute low back or neck pain in the short term and lead to worse outcomes in the long term, results of the first randomized controlled trial testing the efficacy and safety of a short course of opioids for acute nonspecific low back/neck pain suggest.
After 6 weeks, there was no significant difference in pain scores of patients who took opioids, compared with those who took placebo. After 1 year, patients given the placebo had slightly lower pain scores. Also, patients using opioids were at greater risk of opioid misuse after 1 year.
This is a “landmark” trial with “practice-changing” results, senior author Christine Lin, PhD, with the University of Sydney, told this news organization.
“Before this trial, we did not have good evidence on whether opioids were effective for acute low back pain or neck pain, yet opioids were one of the most commonly used medicines for these conditions,” Dr. Lin explained.
On the basis of these results, “opioids should not be recommended at all for acute low back pain and neck pain,” Dr. Lin said.
Results of the OPAL study were published online in The Lancet.
Rigorous trial
The trial was conducted in 157 primary care or emergency department sites in Australia and involved 347 adults who had been experiencing low back pain, neck pain, or both for 12 weeks or less.
They were randomly allocated (1:1) to receive guideline-recommended care (reassurance and advice to stay active) plus an opioid (oxycodone up to 20 mg daily) or identical placebo for up to 6 weeks. Naloxone was provided to help prevent opioid-induced constipation and improve blinding.
The primary outcome was pain severity at 6 weeks, measured with the pain severity subscale of the Brief Pain Inventory (10-point scale).
After 6 weeks, opioid therapy offered no more relief for acute back/neck pain or functional improvement than placebo.
The mean pain score at 6 weeks was 2.78 in the opioid group, versus 2.25 in the placebo group (adjusted mean difference, 0.53; 95% confidence interval, –0.00 to 1.07; P = .051). At 1 year, mean pain scores in the placebo group were slightly lower than in the opioid group (1.8 vs. 2.4).
In addition, there was a doubling of the risk of opioid misuse at 1 year among patients randomly allocated to receive opioid therapy for 6 weeks, compared with those allocated to receive placebo for 6 weeks.
At 1 year, 24 (20%) of 123 of the patients who received opioids were at risk of misuse, as indicated by the Current Opioid Misuse Measure scale, compared with 13 (10%) of 128 patients in the placebo group (P = .049). The COMM is a widely used measure of current aberrant drug-related behavior among patients with chronic pain who are being prescribed opioid therapy.
Results raise ‘serious questions’
“I believe the findings of the study will need to be disseminated to the doctors and patients, so they receive this latest evidence on opioids,” Dr. Lin said in an interview.
“We need to reassure doctors and patients that most people with acute low back pain and neck pain recover well with time (usually by 6 weeks), so management is simple – staying active, avoiding bed rest, and, if necessary, using a heat pack for short term pain relief. If drugs are required, consider anti-inflammatory drugs,” Dr. Lin added.
The authors of a linked comment say the OPAL trial “raises serious questions about the use of opioid therapy for acute low back and neck pain.”
Mark Sullivan, MD, PhD, and Jane Ballantyne, MD, with the University of Washington, Seattle, note that current clinical guidelines recommend opioids for patients with acute back and neck pain when other drug treatments fail or are contraindicated.
“As many as two-thirds of patients might receive an opioid when presenting for care of back or neck pain. It is time to re-examine these guidelines and these practices,” Dr. Sullivan and Dr. Ballantyne conclude.
Funding for the OPAL study was provided by the National Health and Medical Research Council, the University of Sydney Faculty of Medicine and Health, and SafeWork SA. The study authors have disclosed no relevant financial relationships. Dr. Sullivan and Dr. Ballantyne are board members (unpaid) of Physicians for Responsible Opioid Prescribing and have been paid consultants in opioid litigation.
A version of this article originally appeared on Medscape.com.
FDA OKs Suflave, a lower-volume colonoscopy prep drink
, the manufacturer, Sebela Pharmaceuticals, has announced.
Suflave comes in a carton containing two bottles and two flavor packets. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride. One bottle and one flavor packet are equivalent to one dose.
Administration of both doses is required for a complete preparation for colonoscopy. After each dose, an additional 16 ounces of water must be consumed.
In a clinical trial, 94% of patients achieved successful bowel cleansing with Suflave, the company said in a news release.
Most patients reported that Suflave tastes like a sports drink and described the taste as “neutral to very pleasant.” Most patients also reported that Suflave was “tolerable to very easy” to consume and indicated they would request it for a subsequent colonoscopy.
“Patients frequently struggle with the taste and volume of traditional bowel preparations – and fear related to the preparation can also negatively affect patient willingness to undergo follow-up colonoscopy if it is indicated,” Douglas K. Rex, MD, gastroenterologist and distinguished professor emeritus at Indiana University, Indianapolis, said in the release.
“I believe the palatable lemon-lime flavor of Suflave will be a welcomed option for patients – reducing preparation hesitancy and giving more people the chance to feel comfortable during preparation and getting a successful and effective procedure,” Dr. Rex added.
Suflave will be available by prescription to patients in the United States in early August.
A version of this article originally appeared on Medscape.com.
, the manufacturer, Sebela Pharmaceuticals, has announced.
Suflave comes in a carton containing two bottles and two flavor packets. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride. One bottle and one flavor packet are equivalent to one dose.
Administration of both doses is required for a complete preparation for colonoscopy. After each dose, an additional 16 ounces of water must be consumed.
In a clinical trial, 94% of patients achieved successful bowel cleansing with Suflave, the company said in a news release.
Most patients reported that Suflave tastes like a sports drink and described the taste as “neutral to very pleasant.” Most patients also reported that Suflave was “tolerable to very easy” to consume and indicated they would request it for a subsequent colonoscopy.
“Patients frequently struggle with the taste and volume of traditional bowel preparations – and fear related to the preparation can also negatively affect patient willingness to undergo follow-up colonoscopy if it is indicated,” Douglas K. Rex, MD, gastroenterologist and distinguished professor emeritus at Indiana University, Indianapolis, said in the release.
“I believe the palatable lemon-lime flavor of Suflave will be a welcomed option for patients – reducing preparation hesitancy and giving more people the chance to feel comfortable during preparation and getting a successful and effective procedure,” Dr. Rex added.
Suflave will be available by prescription to patients in the United States in early August.
A version of this article originally appeared on Medscape.com.
, the manufacturer, Sebela Pharmaceuticals, has announced.
Suflave comes in a carton containing two bottles and two flavor packets. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride. One bottle and one flavor packet are equivalent to one dose.
Administration of both doses is required for a complete preparation for colonoscopy. After each dose, an additional 16 ounces of water must be consumed.
In a clinical trial, 94% of patients achieved successful bowel cleansing with Suflave, the company said in a news release.
Most patients reported that Suflave tastes like a sports drink and described the taste as “neutral to very pleasant.” Most patients also reported that Suflave was “tolerable to very easy” to consume and indicated they would request it for a subsequent colonoscopy.
“Patients frequently struggle with the taste and volume of traditional bowel preparations – and fear related to the preparation can also negatively affect patient willingness to undergo follow-up colonoscopy if it is indicated,” Douglas K. Rex, MD, gastroenterologist and distinguished professor emeritus at Indiana University, Indianapolis, said in the release.
“I believe the palatable lemon-lime flavor of Suflave will be a welcomed option for patients – reducing preparation hesitancy and giving more people the chance to feel comfortable during preparation and getting a successful and effective procedure,” Dr. Rex added.
Suflave will be available by prescription to patients in the United States in early August.
A version of this article originally appeared on Medscape.com.
AHA statement addresses equity in cardio-oncology care
A new scientific statement from the American Heart Association focuses on equity in cardio-oncology care and research.
A “growing body of evidence” suggests that women and people from underrepresented patient groups experience disproportionately higher cardiovascular effects from new and emerging anticancer therapies, the writing group, led by Daniel Addison, MD, with the Ohio State University, Columbus, pointed out.
For example, women appear to be at higher risk of immune checkpoint inhibitor–related toxicities, whereas Black patients with cancer face up to a threefold higher risk of cardiotoxicity with anticancer therapies.
With reduced screening and delayed preventive measures, Hispanic patients have more complex heart disease, cancer is diagnosed at later stages, and they receive more cardiotoxic regimens because of a lack of eligibility for novel treatments. Ultimately, this contributes to a higher incidence of treatment complications, cardiac dysfunction, and adverse patient outcomes for this patient group, they write.
Although no studies have specifically addressed cardio-oncology disparities in the LGBTQIA+ population, such disparities can be inferred from known cardiovascular disease and oncology disparities, the writing group noted.
These disparities are supported by “disparately high” risk of death after a cancer diagnosis among women and individuals from underrepresented groups, even after accounting for socioeconomic and behavioral patterns, they pointed out.
The scientific statement was published online in Circulation.
Evidence gaps and the path forward
“Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations,” the writing group said.
Decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigations, and potential optimal strategies to address disparate cardiotoxicity with contemporary cancer immunotherapy, as well as biologic and cytotoxic therapies, they noted.
They said caution is needed when interpreting clinical trial data about cardiotoxicity and in generalizing the results because people from diverse racial and ethnic groups have not been well represented in many trials.
The writing group outlined key evidence gaps and future research directions for addressing cardio-oncology disparities, as well as strategies to improve equity in cardio-oncology care and research.
These include the following:
- Identifying specific predictive factors of long-term cardiotoxic risk with targeted and immune-based cancer therapies in women and underrepresented populations.
- Investigating biological mechanisms that may underlie differences in cardiotoxicities between different patient groups.
- Developing personalized cardioprotection strategies that integrate biological, genetic, and social determinant markers.
- Intentionally diversifying clinical trials and identifying optimal strategies to improve representation in cancer clinical trials.
- Determining the role of technology, such as artificial intelligence, in improving cardiotoxicity disparities.
“Conscientiously leveraging technology and designing trials with outcomes related to these issues in practice (considering feasibility and cost) will critically accelerate the field of cardio-oncology in the 21st century. With tangible goals, we can improve health inequities in cardio-oncology,” the writing group said.
The research had no commercial funding. No conflicts of interest were reported.
A version of this article originally appeared on Medscape.com.
A new scientific statement from the American Heart Association focuses on equity in cardio-oncology care and research.
A “growing body of evidence” suggests that women and people from underrepresented patient groups experience disproportionately higher cardiovascular effects from new and emerging anticancer therapies, the writing group, led by Daniel Addison, MD, with the Ohio State University, Columbus, pointed out.
For example, women appear to be at higher risk of immune checkpoint inhibitor–related toxicities, whereas Black patients with cancer face up to a threefold higher risk of cardiotoxicity with anticancer therapies.
With reduced screening and delayed preventive measures, Hispanic patients have more complex heart disease, cancer is diagnosed at later stages, and they receive more cardiotoxic regimens because of a lack of eligibility for novel treatments. Ultimately, this contributes to a higher incidence of treatment complications, cardiac dysfunction, and adverse patient outcomes for this patient group, they write.
Although no studies have specifically addressed cardio-oncology disparities in the LGBTQIA+ population, such disparities can be inferred from known cardiovascular disease and oncology disparities, the writing group noted.
These disparities are supported by “disparately high” risk of death after a cancer diagnosis among women and individuals from underrepresented groups, even after accounting for socioeconomic and behavioral patterns, they pointed out.
The scientific statement was published online in Circulation.
Evidence gaps and the path forward
“Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations,” the writing group said.
Decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigations, and potential optimal strategies to address disparate cardiotoxicity with contemporary cancer immunotherapy, as well as biologic and cytotoxic therapies, they noted.
They said caution is needed when interpreting clinical trial data about cardiotoxicity and in generalizing the results because people from diverse racial and ethnic groups have not been well represented in many trials.
The writing group outlined key evidence gaps and future research directions for addressing cardio-oncology disparities, as well as strategies to improve equity in cardio-oncology care and research.
These include the following:
- Identifying specific predictive factors of long-term cardiotoxic risk with targeted and immune-based cancer therapies in women and underrepresented populations.
- Investigating biological mechanisms that may underlie differences in cardiotoxicities between different patient groups.
- Developing personalized cardioprotection strategies that integrate biological, genetic, and social determinant markers.
- Intentionally diversifying clinical trials and identifying optimal strategies to improve representation in cancer clinical trials.
- Determining the role of technology, such as artificial intelligence, in improving cardiotoxicity disparities.
“Conscientiously leveraging technology and designing trials with outcomes related to these issues in practice (considering feasibility and cost) will critically accelerate the field of cardio-oncology in the 21st century. With tangible goals, we can improve health inequities in cardio-oncology,” the writing group said.
The research had no commercial funding. No conflicts of interest were reported.
A version of this article originally appeared on Medscape.com.
A new scientific statement from the American Heart Association focuses on equity in cardio-oncology care and research.
A “growing body of evidence” suggests that women and people from underrepresented patient groups experience disproportionately higher cardiovascular effects from new and emerging anticancer therapies, the writing group, led by Daniel Addison, MD, with the Ohio State University, Columbus, pointed out.
For example, women appear to be at higher risk of immune checkpoint inhibitor–related toxicities, whereas Black patients with cancer face up to a threefold higher risk of cardiotoxicity with anticancer therapies.
With reduced screening and delayed preventive measures, Hispanic patients have more complex heart disease, cancer is diagnosed at later stages, and they receive more cardiotoxic regimens because of a lack of eligibility for novel treatments. Ultimately, this contributes to a higher incidence of treatment complications, cardiac dysfunction, and adverse patient outcomes for this patient group, they write.
Although no studies have specifically addressed cardio-oncology disparities in the LGBTQIA+ population, such disparities can be inferred from known cardiovascular disease and oncology disparities, the writing group noted.
These disparities are supported by “disparately high” risk of death after a cancer diagnosis among women and individuals from underrepresented groups, even after accounting for socioeconomic and behavioral patterns, they pointed out.
The scientific statement was published online in Circulation.
Evidence gaps and the path forward
“Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations,” the writing group said.
Decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigations, and potential optimal strategies to address disparate cardiotoxicity with contemporary cancer immunotherapy, as well as biologic and cytotoxic therapies, they noted.
They said caution is needed when interpreting clinical trial data about cardiotoxicity and in generalizing the results because people from diverse racial and ethnic groups have not been well represented in many trials.
The writing group outlined key evidence gaps and future research directions for addressing cardio-oncology disparities, as well as strategies to improve equity in cardio-oncology care and research.
These include the following:
- Identifying specific predictive factors of long-term cardiotoxic risk with targeted and immune-based cancer therapies in women and underrepresented populations.
- Investigating biological mechanisms that may underlie differences in cardiotoxicities between different patient groups.
- Developing personalized cardioprotection strategies that integrate biological, genetic, and social determinant markers.
- Intentionally diversifying clinical trials and identifying optimal strategies to improve representation in cancer clinical trials.
- Determining the role of technology, such as artificial intelligence, in improving cardiotoxicity disparities.
“Conscientiously leveraging technology and designing trials with outcomes related to these issues in practice (considering feasibility and cost) will critically accelerate the field of cardio-oncology in the 21st century. With tangible goals, we can improve health inequities in cardio-oncology,” the writing group said.
The research had no commercial funding. No conflicts of interest were reported.
A version of this article originally appeared on Medscape.com.
FROM CIRCULATION
Genetic counseling enhances patient empowerment in familial colorectal cancer
TOPLINE:
, decreased depression, and reduced emotional distress.
METHODOLOGY:
- The researchers enrolled 82 patients (mean age, 44 years; 52% women) who were affected by or at risk for fCRC (Lynch syndrome, associated polyposis conditions, other risk-associated pathogenic variants, and clinically defined fCRC).
- Participants were randomly assigned to receive either standard care or standard care plus genetic counseling.
- Measures included empowerment, anxiety, depression, knowledge, risk perception, emotional distress, screening/surveillance behaviors, perceived social support, decisional conflict, and quality of life.
TAKEAWAY:
- Genetic counseling had a significant effect on patient empowerment after the researchers controlled for precounseling empowerment scores (P = .0043) and depression scores (P = .025).
- Genetic counseling also led to significant improvement in anxiety (P = .04), depression (P = .03), emotional distress (P = .03), and knowledge about fCRC (P = .025).
- Emotional distress appeared to have a moderating effect; those with lower initial levels of emotional distress benefited more from genetic counseling in terms of empowerment (P = .016).
IN PRACTICE:
“Empowerment is particularly important for these patients, since not only does it help them feel they can make real, informed choices, but it also aids their ability to manage their feelings and make plans for the future,” Andrada Ciuca, PhD, with Babes-Bolyai University, Cluj-Napoca, Romania, said in a statement. “An interesting finding was that the more anxiety decreased after their counseling session, the greater the impact was on their empowerment. This highlights the importance of addressing emotional distress during genetic counselling.”
STUDY DETAILS:
The study was conducted by Dr. Ciuca and colleagues. The results were presented at the European Society of Human Genetics 2023 annual conference on June 11.
LIMITATIONS:
The study comprised 82 participants and focused specifically on fCRC.
DISCLOSURES:
No conflicts of interest were disclosed.
A version of this article originally appeared on Medscape.com.
TOPLINE:
, decreased depression, and reduced emotional distress.
METHODOLOGY:
- The researchers enrolled 82 patients (mean age, 44 years; 52% women) who were affected by or at risk for fCRC (Lynch syndrome, associated polyposis conditions, other risk-associated pathogenic variants, and clinically defined fCRC).
- Participants were randomly assigned to receive either standard care or standard care plus genetic counseling.
- Measures included empowerment, anxiety, depression, knowledge, risk perception, emotional distress, screening/surveillance behaviors, perceived social support, decisional conflict, and quality of life.
TAKEAWAY:
- Genetic counseling had a significant effect on patient empowerment after the researchers controlled for precounseling empowerment scores (P = .0043) and depression scores (P = .025).
- Genetic counseling also led to significant improvement in anxiety (P = .04), depression (P = .03), emotional distress (P = .03), and knowledge about fCRC (P = .025).
- Emotional distress appeared to have a moderating effect; those with lower initial levels of emotional distress benefited more from genetic counseling in terms of empowerment (P = .016).
IN PRACTICE:
“Empowerment is particularly important for these patients, since not only does it help them feel they can make real, informed choices, but it also aids their ability to manage their feelings and make plans for the future,” Andrada Ciuca, PhD, with Babes-Bolyai University, Cluj-Napoca, Romania, said in a statement. “An interesting finding was that the more anxiety decreased after their counseling session, the greater the impact was on their empowerment. This highlights the importance of addressing emotional distress during genetic counselling.”
STUDY DETAILS:
The study was conducted by Dr. Ciuca and colleagues. The results were presented at the European Society of Human Genetics 2023 annual conference on June 11.
LIMITATIONS:
The study comprised 82 participants and focused specifically on fCRC.
DISCLOSURES:
No conflicts of interest were disclosed.
A version of this article originally appeared on Medscape.com.
TOPLINE:
, decreased depression, and reduced emotional distress.
METHODOLOGY:
- The researchers enrolled 82 patients (mean age, 44 years; 52% women) who were affected by or at risk for fCRC (Lynch syndrome, associated polyposis conditions, other risk-associated pathogenic variants, and clinically defined fCRC).
- Participants were randomly assigned to receive either standard care or standard care plus genetic counseling.
- Measures included empowerment, anxiety, depression, knowledge, risk perception, emotional distress, screening/surveillance behaviors, perceived social support, decisional conflict, and quality of life.
TAKEAWAY:
- Genetic counseling had a significant effect on patient empowerment after the researchers controlled for precounseling empowerment scores (P = .0043) and depression scores (P = .025).
- Genetic counseling also led to significant improvement in anxiety (P = .04), depression (P = .03), emotional distress (P = .03), and knowledge about fCRC (P = .025).
- Emotional distress appeared to have a moderating effect; those with lower initial levels of emotional distress benefited more from genetic counseling in terms of empowerment (P = .016).
IN PRACTICE:
“Empowerment is particularly important for these patients, since not only does it help them feel they can make real, informed choices, but it also aids their ability to manage their feelings and make plans for the future,” Andrada Ciuca, PhD, with Babes-Bolyai University, Cluj-Napoca, Romania, said in a statement. “An interesting finding was that the more anxiety decreased after their counseling session, the greater the impact was on their empowerment. This highlights the importance of addressing emotional distress during genetic counselling.”
STUDY DETAILS:
The study was conducted by Dr. Ciuca and colleagues. The results were presented at the European Society of Human Genetics 2023 annual conference on June 11.
LIMITATIONS:
The study comprised 82 participants and focused specifically on fCRC.
DISCLOSURES:
No conflicts of interest were disclosed.
A version of this article originally appeared on Medscape.com.
New data on traumatic brain injury show it’s chronic, evolving
The data show that patients with TBI may continue to improve or decline during a period of up to 7 years after injury, making it more of a chronic condition, the investigators report.
“Our results dispute the notion that TBI is a discrete, isolated medical event with a finite, static functional outcome following a relatively short period of upward recovery (typically up to 1 year),” Benjamin Brett, PhD, assistant professor, departments of neurosurgery and neurology, Medical College of Wisconsin, Milwaukee, told this news organization.
“Rather, individuals continue to exhibit improvement and decline across a range of domains, including psychiatric, cognitive, and functional outcomes, even 2-7 years after their injury,” Dr. Brett said.
“Ultimately, our findings support conceptualizing TBI as a chronic condition for many patients, which requires routine follow-up, medical monitoring, responsive care, and support, adapting to their evolving needs many years following injury,” he said.
Results of the TRACK TBI LONG (Transforming Research and Clinical Knowledge in TBI Longitudinal study) were published online in Neurology.
Chronic and evolving
The results are based on 1,264 adults (mean age at injury, 41 years) from the initial TRACK TBI study, including 917 with mild TBI (mTBI) and 193 with moderate/severe TBI (msTBI), who were matched to 154 control patients who had experienced orthopedic trauma without evidence of head injury (OTC).
The participants were followed annually for up to 7 years after injury using the Glasgow Outcome Scale–Extended (GOSE), Brief Symptom Inventory–18 (BSI), and the Brief Test of Adult Cognition by Telephone (BTACT), as well as a self-reported perception of function. The researchers calculated rates of change (classified as stable, improved, or declined) for individual outcomes at each long-term follow-up.
In general, “stable” was the most frequent change outcome for the individual measures from postinjury baseline assessment to 7 years post injury.
However, a substantial proportion of patients with TBI (regardless of severity) experienced changes in psychiatric status, cognition, and functional outcomes over the years.
When the GOSE, BSI, and BTACT were considered collectively, rates of decline were 21% for mTBI, 26% for msTBI, and 15% for OTC.
The highest rates of decline were in functional outcomes (GOSE scores). On average, over the course of 2-7 years post injury, 29% of patients with mTBI and 23% of those with msTBI experienced a decline in the ability to function with daily activities.
A pattern of improvement on the GOSE was noted in 36% of patients with msTBI and 22% patients with mTBI.
Notably, said Dr. Brett, patients who experienced greater difficulties near the time of injury showed improvement for a period of 2-7 years post injury. Patient factors, such as older age at the time of the injury, were associated with greater risk of long-term decline.
“Our findings highlight the need to embrace conceptualization of TBI as a chronic condition in order to establish systems of care that provide continued follow-up with treatment and supports that adapt to evolving patient needs, regardless of the directions of change,” Dr. Brett told this news organization.
Important and novel work
In a linked editorial, Robynne Braun, MD, PhD, with the department of neurology, University of Maryland, Baltimore, notes that there have been “few prospective studies examining postinjury outcomes on this longer timescale, especially in mild TBI, making this an important and novel body of work.”
The study “effectively demonstrates that changes in function across multiple domains continue to occur well beyond the conventionally tracked 6- to 12-month period of injury recovery,” Dr. Braun writes.
The observation that over the 7-year follow-up, a substantial proportion of patients with mTBI and msTBI exhibited a pattern of decline on the GOSE suggests that they “may have needed more ongoing medical monitoring, rehabilitation, or supportive services to prevent worsening,” Dr. Braun adds.
At the same time, the improvement pattern on the GOSE suggests “opportunities for recovery that further rehabilitative or medical services might have enhanced.”
The study was funded by the National Institute of Neurological Disorders and Stroke, the National Institute on Aging, the National Football League Scientific Advisory Board, and the U.S. Department of Defense. Dr. Brett and Dr. Braun have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The data show that patients with TBI may continue to improve or decline during a period of up to 7 years after injury, making it more of a chronic condition, the investigators report.
“Our results dispute the notion that TBI is a discrete, isolated medical event with a finite, static functional outcome following a relatively short period of upward recovery (typically up to 1 year),” Benjamin Brett, PhD, assistant professor, departments of neurosurgery and neurology, Medical College of Wisconsin, Milwaukee, told this news organization.
“Rather, individuals continue to exhibit improvement and decline across a range of domains, including psychiatric, cognitive, and functional outcomes, even 2-7 years after their injury,” Dr. Brett said.
“Ultimately, our findings support conceptualizing TBI as a chronic condition for many patients, which requires routine follow-up, medical monitoring, responsive care, and support, adapting to their evolving needs many years following injury,” he said.
Results of the TRACK TBI LONG (Transforming Research and Clinical Knowledge in TBI Longitudinal study) were published online in Neurology.
Chronic and evolving
The results are based on 1,264 adults (mean age at injury, 41 years) from the initial TRACK TBI study, including 917 with mild TBI (mTBI) and 193 with moderate/severe TBI (msTBI), who were matched to 154 control patients who had experienced orthopedic trauma without evidence of head injury (OTC).
The participants were followed annually for up to 7 years after injury using the Glasgow Outcome Scale–Extended (GOSE), Brief Symptom Inventory–18 (BSI), and the Brief Test of Adult Cognition by Telephone (BTACT), as well as a self-reported perception of function. The researchers calculated rates of change (classified as stable, improved, or declined) for individual outcomes at each long-term follow-up.
In general, “stable” was the most frequent change outcome for the individual measures from postinjury baseline assessment to 7 years post injury.
However, a substantial proportion of patients with TBI (regardless of severity) experienced changes in psychiatric status, cognition, and functional outcomes over the years.
When the GOSE, BSI, and BTACT were considered collectively, rates of decline were 21% for mTBI, 26% for msTBI, and 15% for OTC.
The highest rates of decline were in functional outcomes (GOSE scores). On average, over the course of 2-7 years post injury, 29% of patients with mTBI and 23% of those with msTBI experienced a decline in the ability to function with daily activities.
A pattern of improvement on the GOSE was noted in 36% of patients with msTBI and 22% patients with mTBI.
Notably, said Dr. Brett, patients who experienced greater difficulties near the time of injury showed improvement for a period of 2-7 years post injury. Patient factors, such as older age at the time of the injury, were associated with greater risk of long-term decline.
“Our findings highlight the need to embrace conceptualization of TBI as a chronic condition in order to establish systems of care that provide continued follow-up with treatment and supports that adapt to evolving patient needs, regardless of the directions of change,” Dr. Brett told this news organization.
Important and novel work
In a linked editorial, Robynne Braun, MD, PhD, with the department of neurology, University of Maryland, Baltimore, notes that there have been “few prospective studies examining postinjury outcomes on this longer timescale, especially in mild TBI, making this an important and novel body of work.”
The study “effectively demonstrates that changes in function across multiple domains continue to occur well beyond the conventionally tracked 6- to 12-month period of injury recovery,” Dr. Braun writes.
The observation that over the 7-year follow-up, a substantial proportion of patients with mTBI and msTBI exhibited a pattern of decline on the GOSE suggests that they “may have needed more ongoing medical monitoring, rehabilitation, or supportive services to prevent worsening,” Dr. Braun adds.
At the same time, the improvement pattern on the GOSE suggests “opportunities for recovery that further rehabilitative or medical services might have enhanced.”
The study was funded by the National Institute of Neurological Disorders and Stroke, the National Institute on Aging, the National Football League Scientific Advisory Board, and the U.S. Department of Defense. Dr. Brett and Dr. Braun have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The data show that patients with TBI may continue to improve or decline during a period of up to 7 years after injury, making it more of a chronic condition, the investigators report.
“Our results dispute the notion that TBI is a discrete, isolated medical event with a finite, static functional outcome following a relatively short period of upward recovery (typically up to 1 year),” Benjamin Brett, PhD, assistant professor, departments of neurosurgery and neurology, Medical College of Wisconsin, Milwaukee, told this news organization.
“Rather, individuals continue to exhibit improvement and decline across a range of domains, including psychiatric, cognitive, and functional outcomes, even 2-7 years after their injury,” Dr. Brett said.
“Ultimately, our findings support conceptualizing TBI as a chronic condition for many patients, which requires routine follow-up, medical monitoring, responsive care, and support, adapting to their evolving needs many years following injury,” he said.
Results of the TRACK TBI LONG (Transforming Research and Clinical Knowledge in TBI Longitudinal study) were published online in Neurology.
Chronic and evolving
The results are based on 1,264 adults (mean age at injury, 41 years) from the initial TRACK TBI study, including 917 with mild TBI (mTBI) and 193 with moderate/severe TBI (msTBI), who were matched to 154 control patients who had experienced orthopedic trauma without evidence of head injury (OTC).
The participants were followed annually for up to 7 years after injury using the Glasgow Outcome Scale–Extended (GOSE), Brief Symptom Inventory–18 (BSI), and the Brief Test of Adult Cognition by Telephone (BTACT), as well as a self-reported perception of function. The researchers calculated rates of change (classified as stable, improved, or declined) for individual outcomes at each long-term follow-up.
In general, “stable” was the most frequent change outcome for the individual measures from postinjury baseline assessment to 7 years post injury.
However, a substantial proportion of patients with TBI (regardless of severity) experienced changes in psychiatric status, cognition, and functional outcomes over the years.
When the GOSE, BSI, and BTACT were considered collectively, rates of decline were 21% for mTBI, 26% for msTBI, and 15% for OTC.
The highest rates of decline were in functional outcomes (GOSE scores). On average, over the course of 2-7 years post injury, 29% of patients with mTBI and 23% of those with msTBI experienced a decline in the ability to function with daily activities.
A pattern of improvement on the GOSE was noted in 36% of patients with msTBI and 22% patients with mTBI.
Notably, said Dr. Brett, patients who experienced greater difficulties near the time of injury showed improvement for a period of 2-7 years post injury. Patient factors, such as older age at the time of the injury, were associated with greater risk of long-term decline.
“Our findings highlight the need to embrace conceptualization of TBI as a chronic condition in order to establish systems of care that provide continued follow-up with treatment and supports that adapt to evolving patient needs, regardless of the directions of change,” Dr. Brett told this news organization.
Important and novel work
In a linked editorial, Robynne Braun, MD, PhD, with the department of neurology, University of Maryland, Baltimore, notes that there have been “few prospective studies examining postinjury outcomes on this longer timescale, especially in mild TBI, making this an important and novel body of work.”
The study “effectively demonstrates that changes in function across multiple domains continue to occur well beyond the conventionally tracked 6- to 12-month period of injury recovery,” Dr. Braun writes.
The observation that over the 7-year follow-up, a substantial proportion of patients with mTBI and msTBI exhibited a pattern of decline on the GOSE suggests that they “may have needed more ongoing medical monitoring, rehabilitation, or supportive services to prevent worsening,” Dr. Braun adds.
At the same time, the improvement pattern on the GOSE suggests “opportunities for recovery that further rehabilitative or medical services might have enhanced.”
The study was funded by the National Institute of Neurological Disorders and Stroke, the National Institute on Aging, the National Football League Scientific Advisory Board, and the U.S. Department of Defense. Dr. Brett and Dr. Braun have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM NEUROLOGY
Myasthenia gravis drug gets FDA nod
, the drug’s manufacturer, UCB, has announced.
Rozanolixizumab is a subcutaneous-infused humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), reducing the concentration of pathogenic IgG autoantibodies.
U.S. approval is based on results of the phase 3 MycarinG study involving 200 patients with AChR or MuSK autoantibody-positive gMG. Patients were randomly assigned to one of two rozanolixizumab groups (7 mg/kg or 10 mg/kg) or placebo for 6 weeks.
As reported last month in Lancet Neurology, rozanolixizumab led to statistically significant improvements in gMG-specific outcomes, including everyday activities such as breathing, talking, swallowing, and being able to rise from a chair.
“There is a significant need for new, innovative treatment options to reduce the day-to-day burden of gMG,” lead investigator Vera Bril, MD, professor of medicine (neurology), University of Toronto, said in a news release.
Rozanolixizumab is “a new treatment option, targeting one of the mechanisms of disease to provide symptom improvement in patient- and physician-reported outcomes at day 43,” Dr. Bril added.
The most common adverse reactions (reported in at least 10% of patients treated with rozanolixizumab) were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
The company expects rozanolixizumab to be available in the United States during the third quarter of 2023.
The FDA granted the application for rozanolixizumab in gMG priority review.
A version of this article first appeared on Medscape.com.
, the drug’s manufacturer, UCB, has announced.
Rozanolixizumab is a subcutaneous-infused humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), reducing the concentration of pathogenic IgG autoantibodies.
U.S. approval is based on results of the phase 3 MycarinG study involving 200 patients with AChR or MuSK autoantibody-positive gMG. Patients were randomly assigned to one of two rozanolixizumab groups (7 mg/kg or 10 mg/kg) or placebo for 6 weeks.
As reported last month in Lancet Neurology, rozanolixizumab led to statistically significant improvements in gMG-specific outcomes, including everyday activities such as breathing, talking, swallowing, and being able to rise from a chair.
“There is a significant need for new, innovative treatment options to reduce the day-to-day burden of gMG,” lead investigator Vera Bril, MD, professor of medicine (neurology), University of Toronto, said in a news release.
Rozanolixizumab is “a new treatment option, targeting one of the mechanisms of disease to provide symptom improvement in patient- and physician-reported outcomes at day 43,” Dr. Bril added.
The most common adverse reactions (reported in at least 10% of patients treated with rozanolixizumab) were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
The company expects rozanolixizumab to be available in the United States during the third quarter of 2023.
The FDA granted the application for rozanolixizumab in gMG priority review.
A version of this article first appeared on Medscape.com.
, the drug’s manufacturer, UCB, has announced.
Rozanolixizumab is a subcutaneous-infused humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), reducing the concentration of pathogenic IgG autoantibodies.
U.S. approval is based on results of the phase 3 MycarinG study involving 200 patients with AChR or MuSK autoantibody-positive gMG. Patients were randomly assigned to one of two rozanolixizumab groups (7 mg/kg or 10 mg/kg) or placebo for 6 weeks.
As reported last month in Lancet Neurology, rozanolixizumab led to statistically significant improvements in gMG-specific outcomes, including everyday activities such as breathing, talking, swallowing, and being able to rise from a chair.
“There is a significant need for new, innovative treatment options to reduce the day-to-day burden of gMG,” lead investigator Vera Bril, MD, professor of medicine (neurology), University of Toronto, said in a news release.
Rozanolixizumab is “a new treatment option, targeting one of the mechanisms of disease to provide symptom improvement in patient- and physician-reported outcomes at day 43,” Dr. Bril added.
The most common adverse reactions (reported in at least 10% of patients treated with rozanolixizumab) were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
The company expects rozanolixizumab to be available in the United States during the third quarter of 2023.
The FDA granted the application for rozanolixizumab in gMG priority review.
A version of this article first appeared on Medscape.com.
FDA clears new biomarker assays for early Alzheimer’s detection
The Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys total-tau CSF assays (tTau) (used as a tTau/Abeta42 ratio) are for use in adults ages 55 and older being evaluated for AD.
They join the Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys phospho-tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022.
“An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.
Appropriate use recommendations for new and emerging AD drugs call for confirmation of amyloid pathology. Currently, the only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scans.
“The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid pathology in the brain,” Roche said.
“They also offer detection of both amyloid and tau biomarkers from one draw, with no radiation and potential to detect Alzheimer’s pathology in early stages of disease,” the company added.
The previously approved Elecsys pTau181/Abeta42 ratio is currently available and the newly approved Elecsys tTau/Abeta42 ratio will be available in the fourth quarter of 2023.
A version of this article first appeared on Medscape.com.
The Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys total-tau CSF assays (tTau) (used as a tTau/Abeta42 ratio) are for use in adults ages 55 and older being evaluated for AD.
They join the Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys phospho-tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022.
“An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.
Appropriate use recommendations for new and emerging AD drugs call for confirmation of amyloid pathology. Currently, the only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scans.
“The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid pathology in the brain,” Roche said.
“They also offer detection of both amyloid and tau biomarkers from one draw, with no radiation and potential to detect Alzheimer’s pathology in early stages of disease,” the company added.
The previously approved Elecsys pTau181/Abeta42 ratio is currently available and the newly approved Elecsys tTau/Abeta42 ratio will be available in the fourth quarter of 2023.
A version of this article first appeared on Medscape.com.
The Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys total-tau CSF assays (tTau) (used as a tTau/Abeta42 ratio) are for use in adults ages 55 and older being evaluated for AD.
They join the Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys phospho-tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022.
“An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.
Appropriate use recommendations for new and emerging AD drugs call for confirmation of amyloid pathology. Currently, the only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scans.
“The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid pathology in the brain,” Roche said.
“They also offer detection of both amyloid and tau biomarkers from one draw, with no radiation and potential to detect Alzheimer’s pathology in early stages of disease,” the company added.
The previously approved Elecsys pTau181/Abeta42 ratio is currently available and the newly approved Elecsys tTau/Abeta42 ratio will be available in the fourth quarter of 2023.
A version of this article first appeared on Medscape.com.
Should race and ethnicity be used in CRC recurrence risk algorithms?
Omitting race and ethnicity from colorectal cancer (CRC) recurrence risk prediction models could decrease their accuracy and fairness, particularly for minority groups, potentially leading to inappropriate care advice and contributing to existing health disparities, new research suggests.
“Our study has important implications for developing clinical algorithms that are both accurate and fair,” write first author Sara Khor, MASc, with University of Washington, Seattle, and colleagues.
“Many groups have called for the removal of race in clinical algorithms,” Dr. Khor said in an interview. “We wanted to better understand, using CRC recurrence as a case study, what some of the implications might be if we simply remove race as a predictor in a risk prediction algorithm.”
Their findings suggest that doing so could lead to higher racial bias in model accuracy and less accurate estimation of risk for racial and ethnic minority groups. This could lead to inadequate or inappropriate surveillance and follow-up care more often in patients of minoritized racial and ethnic groups.
The study was published online in JAMA Network Open.
Lack of data and consensus
There is currently a lack of consensus on whether and how race and ethnicity should be included in clinical risk prediction models used to guide health care decisions, the authors note.
The inclusion of race and ethnicity in clinical risk prediction algorithms has come under increased scrutiny, because of concerns over the potential for racial profiling and biased treatment. On the other hand, some argue that excluding race and ethnicity could harm all groups by reducing predictive accuracy and would especially disadvantage minority groups.
It remains unclear whether simply omitting race and ethnicity from algorithms will ultimately improve care decisions for patients of minoritized racial and ethnic groups.
Dr. Khor and colleagues investigated the performance of four risk prediction models for CRC recurrence using data from 4,230 patients with CRC (53% non-Hispanic white; 22% Hispanic; 13% Black or African American; and 12% Asian, Hawaiian, or Pacific Islander).
The four models were:
- A race-neutral model that explicitly excluded race and ethnicity as a predictor.
- A race-sensitive model that included race and ethnicity.
- A model with two-way interactions between clinical predictors and race and ethnicity.
- Separate models stratified by race and ethnicity.
They found that the race-neutral model had poorer performance (worse calibration, negative predictive value, and false-negative rates) among racial and ethnic minority subgroups, compared with the non-Hispanic subgroup. The false-negative rate for Hispanic patients was 12% vs. 3% for non-Hispanic white patients.
Conversely, including race and ethnicity as a predictor of postoperative cancer recurrence improved the model’s accuracy and increased “algorithmic fairness” in terms of calibration slope, discriminative ability, positive predictive value, and false-negative rates. The false-negative rate for Hispanic patients was 9% and 8% for non-Hispanic white patients.
The inclusion of race interaction terms or using race-stratified models did not improve model fairness, likely due to small sample sizes in subgroups, the authors add.
‘No one-size-fits-all answer’
“There is no one-size-fits-all answer to whether race/ethnicity should be included, because the health disparity consequences that can result from each clinical decision are different,” Dr. Khor told this news organization.
“The downstream harms and benefits of including or excluding race will need to be carefully considered in each case,” Dr. Khor said.
“When developing a clinical risk prediction algorithm, one should consider the potential racial/ethnic biases present in clinical practice, which translate to bias in the data,” Dr. Khor added. “Care must be taken to think through the implications of such biases during the algorithm development and evaluation process in order to avoid further propagating those biases.”
The coauthors of a linked commentary say this study “highlights current challenges in measuring and addressing algorithmic bias, with implications for both patient care and health policy decision-making.”
Ankur Pandya, PhD, with Harvard School of Public Health, Boston, and Jinyi Zhu, PhD, with Vanderbilt University, Nashville, Tenn., agree that there is no “one-size-fits-all solution” – such as always excluding race and ethnicity from risk models – to confronting algorithmic bias.
“When possible, approaches for identifying and responding to algorithmic bias should focus on the decisions made by patients and policymakers as they relate to the ultimate outcomes of interest (such as length of life, quality of life, and costs) and the distribution of these outcomes across the subgroups that define important health disparities,” Dr. Pandya and Dr. Zhu suggest.
“What is most promising,” they write, is the high level of engagement from researchers, philosophers, policymakers, physicians and other healthcare professionals, caregivers, and patients to this cause in recent years, “suggesting that algorithmic bias will not be left unchecked as access to unprecedented amounts of data and methods continues to increase moving forward.”
This research was supported by a grant from the National Cancer Institute of the National Institutes of Health. The authors and editorial writers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Omitting race and ethnicity from colorectal cancer (CRC) recurrence risk prediction models could decrease their accuracy and fairness, particularly for minority groups, potentially leading to inappropriate care advice and contributing to existing health disparities, new research suggests.
“Our study has important implications for developing clinical algorithms that are both accurate and fair,” write first author Sara Khor, MASc, with University of Washington, Seattle, and colleagues.
“Many groups have called for the removal of race in clinical algorithms,” Dr. Khor said in an interview. “We wanted to better understand, using CRC recurrence as a case study, what some of the implications might be if we simply remove race as a predictor in a risk prediction algorithm.”
Their findings suggest that doing so could lead to higher racial bias in model accuracy and less accurate estimation of risk for racial and ethnic minority groups. This could lead to inadequate or inappropriate surveillance and follow-up care more often in patients of minoritized racial and ethnic groups.
The study was published online in JAMA Network Open.
Lack of data and consensus
There is currently a lack of consensus on whether and how race and ethnicity should be included in clinical risk prediction models used to guide health care decisions, the authors note.
The inclusion of race and ethnicity in clinical risk prediction algorithms has come under increased scrutiny, because of concerns over the potential for racial profiling and biased treatment. On the other hand, some argue that excluding race and ethnicity could harm all groups by reducing predictive accuracy and would especially disadvantage minority groups.
It remains unclear whether simply omitting race and ethnicity from algorithms will ultimately improve care decisions for patients of minoritized racial and ethnic groups.
Dr. Khor and colleagues investigated the performance of four risk prediction models for CRC recurrence using data from 4,230 patients with CRC (53% non-Hispanic white; 22% Hispanic; 13% Black or African American; and 12% Asian, Hawaiian, or Pacific Islander).
The four models were:
- A race-neutral model that explicitly excluded race and ethnicity as a predictor.
- A race-sensitive model that included race and ethnicity.
- A model with two-way interactions between clinical predictors and race and ethnicity.
- Separate models stratified by race and ethnicity.
They found that the race-neutral model had poorer performance (worse calibration, negative predictive value, and false-negative rates) among racial and ethnic minority subgroups, compared with the non-Hispanic subgroup. The false-negative rate for Hispanic patients was 12% vs. 3% for non-Hispanic white patients.
Conversely, including race and ethnicity as a predictor of postoperative cancer recurrence improved the model’s accuracy and increased “algorithmic fairness” in terms of calibration slope, discriminative ability, positive predictive value, and false-negative rates. The false-negative rate for Hispanic patients was 9% and 8% for non-Hispanic white patients.
The inclusion of race interaction terms or using race-stratified models did not improve model fairness, likely due to small sample sizes in subgroups, the authors add.
‘No one-size-fits-all answer’
“There is no one-size-fits-all answer to whether race/ethnicity should be included, because the health disparity consequences that can result from each clinical decision are different,” Dr. Khor told this news organization.
“The downstream harms and benefits of including or excluding race will need to be carefully considered in each case,” Dr. Khor said.
“When developing a clinical risk prediction algorithm, one should consider the potential racial/ethnic biases present in clinical practice, which translate to bias in the data,” Dr. Khor added. “Care must be taken to think through the implications of such biases during the algorithm development and evaluation process in order to avoid further propagating those biases.”
The coauthors of a linked commentary say this study “highlights current challenges in measuring and addressing algorithmic bias, with implications for both patient care and health policy decision-making.”
Ankur Pandya, PhD, with Harvard School of Public Health, Boston, and Jinyi Zhu, PhD, with Vanderbilt University, Nashville, Tenn., agree that there is no “one-size-fits-all solution” – such as always excluding race and ethnicity from risk models – to confronting algorithmic bias.
“When possible, approaches for identifying and responding to algorithmic bias should focus on the decisions made by patients and policymakers as they relate to the ultimate outcomes of interest (such as length of life, quality of life, and costs) and the distribution of these outcomes across the subgroups that define important health disparities,” Dr. Pandya and Dr. Zhu suggest.
“What is most promising,” they write, is the high level of engagement from researchers, philosophers, policymakers, physicians and other healthcare professionals, caregivers, and patients to this cause in recent years, “suggesting that algorithmic bias will not be left unchecked as access to unprecedented amounts of data and methods continues to increase moving forward.”
This research was supported by a grant from the National Cancer Institute of the National Institutes of Health. The authors and editorial writers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Omitting race and ethnicity from colorectal cancer (CRC) recurrence risk prediction models could decrease their accuracy and fairness, particularly for minority groups, potentially leading to inappropriate care advice and contributing to existing health disparities, new research suggests.
“Our study has important implications for developing clinical algorithms that are both accurate and fair,” write first author Sara Khor, MASc, with University of Washington, Seattle, and colleagues.
“Many groups have called for the removal of race in clinical algorithms,” Dr. Khor said in an interview. “We wanted to better understand, using CRC recurrence as a case study, what some of the implications might be if we simply remove race as a predictor in a risk prediction algorithm.”
Their findings suggest that doing so could lead to higher racial bias in model accuracy and less accurate estimation of risk for racial and ethnic minority groups. This could lead to inadequate or inappropriate surveillance and follow-up care more often in patients of minoritized racial and ethnic groups.
The study was published online in JAMA Network Open.
Lack of data and consensus
There is currently a lack of consensus on whether and how race and ethnicity should be included in clinical risk prediction models used to guide health care decisions, the authors note.
The inclusion of race and ethnicity in clinical risk prediction algorithms has come under increased scrutiny, because of concerns over the potential for racial profiling and biased treatment. On the other hand, some argue that excluding race and ethnicity could harm all groups by reducing predictive accuracy and would especially disadvantage minority groups.
It remains unclear whether simply omitting race and ethnicity from algorithms will ultimately improve care decisions for patients of minoritized racial and ethnic groups.
Dr. Khor and colleagues investigated the performance of four risk prediction models for CRC recurrence using data from 4,230 patients with CRC (53% non-Hispanic white; 22% Hispanic; 13% Black or African American; and 12% Asian, Hawaiian, or Pacific Islander).
The four models were:
- A race-neutral model that explicitly excluded race and ethnicity as a predictor.
- A race-sensitive model that included race and ethnicity.
- A model with two-way interactions between clinical predictors and race and ethnicity.
- Separate models stratified by race and ethnicity.
They found that the race-neutral model had poorer performance (worse calibration, negative predictive value, and false-negative rates) among racial and ethnic minority subgroups, compared with the non-Hispanic subgroup. The false-negative rate for Hispanic patients was 12% vs. 3% for non-Hispanic white patients.
Conversely, including race and ethnicity as a predictor of postoperative cancer recurrence improved the model’s accuracy and increased “algorithmic fairness” in terms of calibration slope, discriminative ability, positive predictive value, and false-negative rates. The false-negative rate for Hispanic patients was 9% and 8% for non-Hispanic white patients.
The inclusion of race interaction terms or using race-stratified models did not improve model fairness, likely due to small sample sizes in subgroups, the authors add.
‘No one-size-fits-all answer’
“There is no one-size-fits-all answer to whether race/ethnicity should be included, because the health disparity consequences that can result from each clinical decision are different,” Dr. Khor told this news organization.
“The downstream harms and benefits of including or excluding race will need to be carefully considered in each case,” Dr. Khor said.
“When developing a clinical risk prediction algorithm, one should consider the potential racial/ethnic biases present in clinical practice, which translate to bias in the data,” Dr. Khor added. “Care must be taken to think through the implications of such biases during the algorithm development and evaluation process in order to avoid further propagating those biases.”
The coauthors of a linked commentary say this study “highlights current challenges in measuring and addressing algorithmic bias, with implications for both patient care and health policy decision-making.”
Ankur Pandya, PhD, with Harvard School of Public Health, Boston, and Jinyi Zhu, PhD, with Vanderbilt University, Nashville, Tenn., agree that there is no “one-size-fits-all solution” – such as always excluding race and ethnicity from risk models – to confronting algorithmic bias.
“When possible, approaches for identifying and responding to algorithmic bias should focus on the decisions made by patients and policymakers as they relate to the ultimate outcomes of interest (such as length of life, quality of life, and costs) and the distribution of these outcomes across the subgroups that define important health disparities,” Dr. Pandya and Dr. Zhu suggest.
“What is most promising,” they write, is the high level of engagement from researchers, philosophers, policymakers, physicians and other healthcare professionals, caregivers, and patients to this cause in recent years, “suggesting that algorithmic bias will not be left unchecked as access to unprecedented amounts of data and methods continues to increase moving forward.”
This research was supported by a grant from the National Cancer Institute of the National Institutes of Health. The authors and editorial writers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
No link between PPIs and dementia in new study
TOPLINE:
A new study provides reassurance about the long-term safety of proton pump inhibitors (PPIs) and histamine-2 receptor antagonist (H2RA) use in older adults, finding no increased risk for dementia or cognitive changes.
METHODOLOGY:
- Post hoc observational study within the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial.
- 18,934 adults aged 65+ from the United States and Australia without dementia at baseline.
- 4,667 (25%) PPI users and 368 (2%) H2RA users at baseline.
- PPI and H2RA use, dementia incidence, and cognitive changes were tracked.
TAKEAWAY:
- In multivariable analysis, baseline PPI use was not associated with incident dementia (hazard ratio, 0.88) or cognitive impairment (HR, 1.00).
- PPI use was not linked to changes in overall cognitive test scores over time (beta –0.002).
- No associations were found between H2RA use and cognitive endpoints.
IN PRACTICE:
“Long-term use of PPIs in older adults is unlikely to have negative effects on cognition,” the study team concludes.
STUDY DETAILS:
The study was led by Raaj Mehta, MD, PhD, with Massachusetts General Hospital and Harvard Medical School in Boston. The study was published online in Gastroenterology. Funding was provided by grants from the National Institute on Aging, the National Cancer Institute, and other institutions.
LIMITATIONS:
Potential for residual confounding and underestimation of PPI and H2RA use, lack of data on medication dose and duration, and the absence of ApoE4 allele status.
DISCLOSURES:
Dr. Mehta has disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
A new study provides reassurance about the long-term safety of proton pump inhibitors (PPIs) and histamine-2 receptor antagonist (H2RA) use in older adults, finding no increased risk for dementia or cognitive changes.
METHODOLOGY:
- Post hoc observational study within the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial.
- 18,934 adults aged 65+ from the United States and Australia without dementia at baseline.
- 4,667 (25%) PPI users and 368 (2%) H2RA users at baseline.
- PPI and H2RA use, dementia incidence, and cognitive changes were tracked.
TAKEAWAY:
- In multivariable analysis, baseline PPI use was not associated with incident dementia (hazard ratio, 0.88) or cognitive impairment (HR, 1.00).
- PPI use was not linked to changes in overall cognitive test scores over time (beta –0.002).
- No associations were found between H2RA use and cognitive endpoints.
IN PRACTICE:
“Long-term use of PPIs in older adults is unlikely to have negative effects on cognition,” the study team concludes.
STUDY DETAILS:
The study was led by Raaj Mehta, MD, PhD, with Massachusetts General Hospital and Harvard Medical School in Boston. The study was published online in Gastroenterology. Funding was provided by grants from the National Institute on Aging, the National Cancer Institute, and other institutions.
LIMITATIONS:
Potential for residual confounding and underestimation of PPI and H2RA use, lack of data on medication dose and duration, and the absence of ApoE4 allele status.
DISCLOSURES:
Dr. Mehta has disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
A new study provides reassurance about the long-term safety of proton pump inhibitors (PPIs) and histamine-2 receptor antagonist (H2RA) use in older adults, finding no increased risk for dementia or cognitive changes.
METHODOLOGY:
- Post hoc observational study within the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial.
- 18,934 adults aged 65+ from the United States and Australia without dementia at baseline.
- 4,667 (25%) PPI users and 368 (2%) H2RA users at baseline.
- PPI and H2RA use, dementia incidence, and cognitive changes were tracked.
TAKEAWAY:
- In multivariable analysis, baseline PPI use was not associated with incident dementia (hazard ratio, 0.88) or cognitive impairment (HR, 1.00).
- PPI use was not linked to changes in overall cognitive test scores over time (beta –0.002).
- No associations were found between H2RA use and cognitive endpoints.
IN PRACTICE:
“Long-term use of PPIs in older adults is unlikely to have negative effects on cognition,” the study team concludes.
STUDY DETAILS:
The study was led by Raaj Mehta, MD, PhD, with Massachusetts General Hospital and Harvard Medical School in Boston. The study was published online in Gastroenterology. Funding was provided by grants from the National Institute on Aging, the National Cancer Institute, and other institutions.
LIMITATIONS:
Potential for residual confounding and underestimation of PPI and H2RA use, lack of data on medication dose and duration, and the absence of ApoE4 allele status.
DISCLOSURES:
Dr. Mehta has disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Final USPSTF recommendations on anxiety, depression, suicide risk
In line with draft recommendations, the task force for the first time has endorsed screening for anxiety disorders in all adults younger than age 65 without recognized signs or symptoms of anxiety.
This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit. There currently is not enough evidence to recommend for or against screening for anxiety disorders in adults 65 and older, the task force said.
The USPSTF final recommendation statements and corresponding evidence summaries were published online in the Journal of the American Medical Association, as well as on the task force website.
Jury out on screening for suicide risk
The task force continues to recommend screening all adults for depression. This “B” recommendation reflects moderate-certainty evidence that screening for major depression in adults has a moderate net benefit.
However, there is not enough evidence to recommend for or against screening for suicide risk in all adults. Therefore, the task issued an “I” statement, indicating that the balance of benefits and harms cannot be determined at present.
“We are urgently calling for more research to determine the effectiveness of screening all adults for suicide risk and screening adults 65 and older for anxiety disorders,” task force member Gbenga Ogedegbe, MD, MPH, founding director of the Institute for Excellence in Health Equity at NYU Langone Health, New York, said in a statement.
The authors of an accompanying editorial noted that a positive screen result for anxiety “should be immediately followed with clinical evaluation for suicidality”.
Murray Stein, MD, MPH, and Linda Hill, MD, MPH, both with University of California, San Diego, also noted that a positive screen for anxiety could be indicative of posttraumatic stress disorder (PTSD) and clinicians should “be prepared to follow up with requisite questions about traumatic experiences that will be needed to home in on a diagnosis of PTSD that may require additional follow-up, referral, or both.
“Anxiety disorders can be distressing and disabling, and appropriate recognition and treatment can be life-altering and, in some cases, lifesaving, for patients,” Dr. Stein and Dr. Hill pointed out.
Effective, evidence-based psychological and pharmacologic treatments for anxiety disorders are available, they added. But the recommendation to routinely screen for anxiety disorder “must be accompanied by the recognition that there are too few mental health specialists available to manage the care of all patients with anxiety disorders, and even fewer who provide services for low-income and non-English-speaking populations,” they wrote.
This research report received no commercial funding. Disclosures for task force members and editorial writers are listed with the original articles.
A version of this article originally appeared on Medscape.com.
In line with draft recommendations, the task force for the first time has endorsed screening for anxiety disorders in all adults younger than age 65 without recognized signs or symptoms of anxiety.
This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit. There currently is not enough evidence to recommend for or against screening for anxiety disorders in adults 65 and older, the task force said.
The USPSTF final recommendation statements and corresponding evidence summaries were published online in the Journal of the American Medical Association, as well as on the task force website.
Jury out on screening for suicide risk
The task force continues to recommend screening all adults for depression. This “B” recommendation reflects moderate-certainty evidence that screening for major depression in adults has a moderate net benefit.
However, there is not enough evidence to recommend for or against screening for suicide risk in all adults. Therefore, the task issued an “I” statement, indicating that the balance of benefits and harms cannot be determined at present.
“We are urgently calling for more research to determine the effectiveness of screening all adults for suicide risk and screening adults 65 and older for anxiety disorders,” task force member Gbenga Ogedegbe, MD, MPH, founding director of the Institute for Excellence in Health Equity at NYU Langone Health, New York, said in a statement.
The authors of an accompanying editorial noted that a positive screen result for anxiety “should be immediately followed with clinical evaluation for suicidality”.
Murray Stein, MD, MPH, and Linda Hill, MD, MPH, both with University of California, San Diego, also noted that a positive screen for anxiety could be indicative of posttraumatic stress disorder (PTSD) and clinicians should “be prepared to follow up with requisite questions about traumatic experiences that will be needed to home in on a diagnosis of PTSD that may require additional follow-up, referral, or both.
“Anxiety disorders can be distressing and disabling, and appropriate recognition and treatment can be life-altering and, in some cases, lifesaving, for patients,” Dr. Stein and Dr. Hill pointed out.
Effective, evidence-based psychological and pharmacologic treatments for anxiety disorders are available, they added. But the recommendation to routinely screen for anxiety disorder “must be accompanied by the recognition that there are too few mental health specialists available to manage the care of all patients with anxiety disorders, and even fewer who provide services for low-income and non-English-speaking populations,” they wrote.
This research report received no commercial funding. Disclosures for task force members and editorial writers are listed with the original articles.
A version of this article originally appeared on Medscape.com.
In line with draft recommendations, the task force for the first time has endorsed screening for anxiety disorders in all adults younger than age 65 without recognized signs or symptoms of anxiety.
This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit. There currently is not enough evidence to recommend for or against screening for anxiety disorders in adults 65 and older, the task force said.
The USPSTF final recommendation statements and corresponding evidence summaries were published online in the Journal of the American Medical Association, as well as on the task force website.
Jury out on screening for suicide risk
The task force continues to recommend screening all adults for depression. This “B” recommendation reflects moderate-certainty evidence that screening for major depression in adults has a moderate net benefit.
However, there is not enough evidence to recommend for or against screening for suicide risk in all adults. Therefore, the task issued an “I” statement, indicating that the balance of benefits and harms cannot be determined at present.
“We are urgently calling for more research to determine the effectiveness of screening all adults for suicide risk and screening adults 65 and older for anxiety disorders,” task force member Gbenga Ogedegbe, MD, MPH, founding director of the Institute for Excellence in Health Equity at NYU Langone Health, New York, said in a statement.
The authors of an accompanying editorial noted that a positive screen result for anxiety “should be immediately followed with clinical evaluation for suicidality”.
Murray Stein, MD, MPH, and Linda Hill, MD, MPH, both with University of California, San Diego, also noted that a positive screen for anxiety could be indicative of posttraumatic stress disorder (PTSD) and clinicians should “be prepared to follow up with requisite questions about traumatic experiences that will be needed to home in on a diagnosis of PTSD that may require additional follow-up, referral, or both.
“Anxiety disorders can be distressing and disabling, and appropriate recognition and treatment can be life-altering and, in some cases, lifesaving, for patients,” Dr. Stein and Dr. Hill pointed out.
Effective, evidence-based psychological and pharmacologic treatments for anxiety disorders are available, they added. But the recommendation to routinely screen for anxiety disorder “must be accompanied by the recognition that there are too few mental health specialists available to manage the care of all patients with anxiety disorders, and even fewer who provide services for low-income and non-English-speaking populations,” they wrote.
This research report received no commercial funding. Disclosures for task force members and editorial writers are listed with the original articles.
A version of this article originally appeared on Medscape.com.