User login
Total replacement and fusion yield similar outcomes for ankle osteoarthritis
Ankle osteoarthritis remains a cause of severe pain and disability. Patients are treated nonoperatively if possible, but surgery is often needed for individuals with end-stage disease, wrote Andrew Goldberg, MBBS, of University College London and colleagues in the Annals of Internal Medicine.
“Most patients with ankle arthritis respond to nonoperative treatments, such as weight loss, activity modification, support braces, and analgesia, [but] once the disease has progressed to end-stage osteoarthritis, the main surgical treatments are total ankle re-placement or ankle arthrodesis,” Dr. Goldberg said, in an interview.
In the new study, patients were randomized to receive either a total ankle replacement (TAR) or ankle fusion (AF).
“We showed that, in both treatment groups the clinical scores improved hugely, by more than three times the minimal clinically important difference,” Dr. Goldberg said in an interview.
“Although the ankle replacement arm improved, on average, by more than an extra 4 points over ankle fusion, this was not considered clinically or statistically significant,” he said.
The study is the first randomized trial to show high-quality and robust results, he noted, and findings support data from previous studies.
“Although both TAR and ankle fusion have been shown to be effective, they are very different treatments, with one fusing the bones so that there is no ankle joint movement, and the other replacing the joint with the aim of retaining ankle joint movement. It is difficult for a patient to know which treatment is more suitable for them, with most seeking guidance from their surgeon,” he said.
Generating high-quality evidence
The study, a randomized, multicenter, open-label trial known as TARVA (Total Ankle Replacement Versus Ankle Arthrodesis), aimed to compare the clinical effectiveness of the two existing publicly funded U.K. treatment options, the authors wrote.
Patients were recruited at 17 U.K. centers between March 6, 2015, and Jan. 10, 2019. The study enrolled 303 adults aged 50-85 years with end-stage ankle osteoarthritis. The mean age of the participants was 68 years; 71% were men. A total of 137 TAR patients and 144 ankle fusion patients completed their surgeries with clinical scores available for analysis. Baseline characteristics were mainly similar between the groups.
Blinding was not possible because of the nature of the procedures, but the surgeons who screened the patients were not aware of the randomization allocations, the researchers noted. A total of 33 surgeons participated in the trial, with a median number of seven patients per surgeon during the study period.
For TAR, U.K. surgeons use both two-component, fixed-bearing and three-component, mobile-bearing implants, the authors write. Ankle fusion was done using the surgeon’s usual technique of either arthroscopic-assisted or open ankle fusion.
The primary outcome was the change in the Manchester–Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores from baseline to 52 weeks after surgery. The MOXFQ-W/S uses a scale of 0-100, with lower scores representing better outcomes. Secondary outcomes included change in the MOXFQ-W/S scores at 26 weeks after surgery, as well as measures of patient quality of life.
No statistically significant difference
Overall, the mean MOXFQ-W/S scores improved significantly from baseline to 52 weeks for both groups, with average improvements of 49.9 in the TAR group and 44.4 points in the AF group. The average scores at 52 weeks were 31.4 in the TAR group and 36.8 in the AF group.
The adjusted difference in score change from baseline was –5.56, showing a slightly greater degree of improvement with TAR, but this difference was not clinically or statistically significant, the researchers noted.
Adverse event numbers were similar for both procedures, with 54% of TAR patients and 53% of AF patients experiencing at least 1 adverse event during the study period. Of those, 18% of TAR patients and 24% of AF patients experienced at least 1 serious adverse event.
However, the TAR patients experienced a higher rate of wound healing complications and nerve injuries, while thromboembolism was higher in the AF patients, the researchers noted.
A prespecified subgroup analysis of patients with osteoarthritis in adjacent joints suggested a greater improvement in TAR, compared with AF, a difference that increased when fixed-bearing TAR was compared with AF, the authors wrote.
“This reinforces previous reports that suggest that the presence of adjacent joint arthritis may be an indication for ankle replacement over AF,” the authors wrote in their discussion.
“Many of these patients did not have any symptoms in the adjacent joints,” they noted.
“The presence of adjacent joint arthritis, meaning the wear and tear of the joints around the ankle joint, seemed to favor ankle replacement,” Dr. Goldberg said. Approximately 30 joints in the foot continue to move after the ankle is fused, and if these adjacent joints are not healthy before surgery [as was the case in 42% of the study patients], the results of fusion were less successful, he explained.
A post hoc analysis between TAR subtypes showed that patients who had fixed-bearing TAR had significantly greater improvements, compared with AF patients, but this difference was not observed in patients who had mobile-bearing TAR, the researchers noted.
Dr. Goldberg said it was surprising “that, in a separate analysis, we found that the fixed-bearing ankle replacement patients [who accounted for half of the implants used] improved by a much greater difference when compared to ankle fusion.”
The study findings were limited by several factors including the short follow-up and study design that allowed surgeons to choose any implant and technique, the researchers noted.
Other limitations include a lack of data on cost-effectiveness and the impact of comorbidities on outcomes, they wrote. However, the study is the first completed multicenter randomized controlled trial to compare TAR and AF procedures for end-stage ankle osteoarthritis and shows that both yield similar clinical improvements, they concluded.
Data can inform treatment discussion
The take-home messages for clinicians are that both ankle replacement and ankle fusion are effective treatments that improve patients’ quality of life, and it is important to establish the health of adjacent joints before making treatment recommendations, Dr. Goldberg said.
“Careful counseling on the relative risks of each procedure should be part of the informed consent process,” he added. Ideally, all patients seeking surgical care for ankle arthritis should have a choice between ankle replacement and ankle fusion, but sometimes there is inequity of provision of the two treatments, he noted.
“We now encourage all surgeons to work in ankle arthritis networks so that every patient, no matter where they live, can have choice about the best treatment for them,” he said.
Researchers met the challenge of surgical RCT
Randomized trials of surgical interventions are challenging to conduct, and therefore limited, wrote Bruce Sangeorzan, MD, of the University of Washington, Seattle, and colleagues in an accompanying editorial. However, the new study was strengthened by the inclusion of 17 centers for heterogeneity of implant type and surgeon experience level, the editorialists said in the Annals of Internal Medicine.
The study is especially important, because ankle arthritis treatment is very understudied, compared with hip and knee arthritis, but it has a similar impact on activity, editorial coauthor Dr. Sangeorzan said in an interview.
“Randomized controlled trials are the gold standard for comparing medical therapies,” he said, “but they are very difficult to do in surgical treatments, particularly when the two treatments can be differentiated, in this case by movement of the ankle.”
In addition, there is a strong placebo effect attached to interventions, Dr. Sangeorzan noted. “Determining best-case treatment relies on prospective research, preferably randomized. Since both ankle fusion and ankle replacement are effective therapies, a prospective randomized trial is the best way to help make treatment decisions,” he said.
The current study findings are not surprising, but they are preliminary, and 1 year of follow-up is not enough to determine effectiveness, Dr. Sangeorzan emphasized. However, “the authors have done the hard work of randomizing the patients and collecting the data, and the patients can now be followed for a longer time,” he said.
“In addition, the trial was designed with multiple secondary outcome measures, so the data can be matched up with larger trials that were not randomized to identify key elements of success for each procedure,” he noted.
The key message for clinicians is that ankle arthritis has a significant impact on patients’ lives, but there are two effective treatments that can reduce the impact of the disease, said Dr. Sangeorzan. “The data suggest that there are differences in implant design and differences in comorbidities that should influence decision-making,” he added.
Additional research is needed in the form of a longer study duration with larger cohorts, said Dr. Sangeorzan. In particular, researchers need to determine what comorbidities might drive patients to one type of care vs. another, he said. “The suggestion that [patients receiving implants with two motion segments have better outcomes than those receiving implants with a one-motion segment] also deserves further study,” he added.
The research was supported by the UK National Institute for Health and Care Research Health Technology Assessment Programme. The trial was sponsored by University College London. Dr. Goldberg disclosed grant support from NIHR HTA, as well as financial relationships with companies including Stryker, Paragon 28, and stock options with Standing CT Company, Elstree Waterfront Outpatients, and X Bolt Orthopedics.
The editorialists had no financial conflicts to disclose.
Ankle osteoarthritis remains a cause of severe pain and disability. Patients are treated nonoperatively if possible, but surgery is often needed for individuals with end-stage disease, wrote Andrew Goldberg, MBBS, of University College London and colleagues in the Annals of Internal Medicine.
“Most patients with ankle arthritis respond to nonoperative treatments, such as weight loss, activity modification, support braces, and analgesia, [but] once the disease has progressed to end-stage osteoarthritis, the main surgical treatments are total ankle re-placement or ankle arthrodesis,” Dr. Goldberg said, in an interview.
In the new study, patients were randomized to receive either a total ankle replacement (TAR) or ankle fusion (AF).
“We showed that, in both treatment groups the clinical scores improved hugely, by more than three times the minimal clinically important difference,” Dr. Goldberg said in an interview.
“Although the ankle replacement arm improved, on average, by more than an extra 4 points over ankle fusion, this was not considered clinically or statistically significant,” he said.
The study is the first randomized trial to show high-quality and robust results, he noted, and findings support data from previous studies.
“Although both TAR and ankle fusion have been shown to be effective, they are very different treatments, with one fusing the bones so that there is no ankle joint movement, and the other replacing the joint with the aim of retaining ankle joint movement. It is difficult for a patient to know which treatment is more suitable for them, with most seeking guidance from their surgeon,” he said.
Generating high-quality evidence
The study, a randomized, multicenter, open-label trial known as TARVA (Total Ankle Replacement Versus Ankle Arthrodesis), aimed to compare the clinical effectiveness of the two existing publicly funded U.K. treatment options, the authors wrote.
Patients were recruited at 17 U.K. centers between March 6, 2015, and Jan. 10, 2019. The study enrolled 303 adults aged 50-85 years with end-stage ankle osteoarthritis. The mean age of the participants was 68 years; 71% were men. A total of 137 TAR patients and 144 ankle fusion patients completed their surgeries with clinical scores available for analysis. Baseline characteristics were mainly similar between the groups.
Blinding was not possible because of the nature of the procedures, but the surgeons who screened the patients were not aware of the randomization allocations, the researchers noted. A total of 33 surgeons participated in the trial, with a median number of seven patients per surgeon during the study period.
For TAR, U.K. surgeons use both two-component, fixed-bearing and three-component, mobile-bearing implants, the authors write. Ankle fusion was done using the surgeon’s usual technique of either arthroscopic-assisted or open ankle fusion.
The primary outcome was the change in the Manchester–Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores from baseline to 52 weeks after surgery. The MOXFQ-W/S uses a scale of 0-100, with lower scores representing better outcomes. Secondary outcomes included change in the MOXFQ-W/S scores at 26 weeks after surgery, as well as measures of patient quality of life.
No statistically significant difference
Overall, the mean MOXFQ-W/S scores improved significantly from baseline to 52 weeks for both groups, with average improvements of 49.9 in the TAR group and 44.4 points in the AF group. The average scores at 52 weeks were 31.4 in the TAR group and 36.8 in the AF group.
The adjusted difference in score change from baseline was –5.56, showing a slightly greater degree of improvement with TAR, but this difference was not clinically or statistically significant, the researchers noted.
Adverse event numbers were similar for both procedures, with 54% of TAR patients and 53% of AF patients experiencing at least 1 adverse event during the study period. Of those, 18% of TAR patients and 24% of AF patients experienced at least 1 serious adverse event.
However, the TAR patients experienced a higher rate of wound healing complications and nerve injuries, while thromboembolism was higher in the AF patients, the researchers noted.
A prespecified subgroup analysis of patients with osteoarthritis in adjacent joints suggested a greater improvement in TAR, compared with AF, a difference that increased when fixed-bearing TAR was compared with AF, the authors wrote.
“This reinforces previous reports that suggest that the presence of adjacent joint arthritis may be an indication for ankle replacement over AF,” the authors wrote in their discussion.
“Many of these patients did not have any symptoms in the adjacent joints,” they noted.
“The presence of adjacent joint arthritis, meaning the wear and tear of the joints around the ankle joint, seemed to favor ankle replacement,” Dr. Goldberg said. Approximately 30 joints in the foot continue to move after the ankle is fused, and if these adjacent joints are not healthy before surgery [as was the case in 42% of the study patients], the results of fusion were less successful, he explained.
A post hoc analysis between TAR subtypes showed that patients who had fixed-bearing TAR had significantly greater improvements, compared with AF patients, but this difference was not observed in patients who had mobile-bearing TAR, the researchers noted.
Dr. Goldberg said it was surprising “that, in a separate analysis, we found that the fixed-bearing ankle replacement patients [who accounted for half of the implants used] improved by a much greater difference when compared to ankle fusion.”
The study findings were limited by several factors including the short follow-up and study design that allowed surgeons to choose any implant and technique, the researchers noted.
Other limitations include a lack of data on cost-effectiveness and the impact of comorbidities on outcomes, they wrote. However, the study is the first completed multicenter randomized controlled trial to compare TAR and AF procedures for end-stage ankle osteoarthritis and shows that both yield similar clinical improvements, they concluded.
Data can inform treatment discussion
The take-home messages for clinicians are that both ankle replacement and ankle fusion are effective treatments that improve patients’ quality of life, and it is important to establish the health of adjacent joints before making treatment recommendations, Dr. Goldberg said.
“Careful counseling on the relative risks of each procedure should be part of the informed consent process,” he added. Ideally, all patients seeking surgical care for ankle arthritis should have a choice between ankle replacement and ankle fusion, but sometimes there is inequity of provision of the two treatments, he noted.
“We now encourage all surgeons to work in ankle arthritis networks so that every patient, no matter where they live, can have choice about the best treatment for them,” he said.
Researchers met the challenge of surgical RCT
Randomized trials of surgical interventions are challenging to conduct, and therefore limited, wrote Bruce Sangeorzan, MD, of the University of Washington, Seattle, and colleagues in an accompanying editorial. However, the new study was strengthened by the inclusion of 17 centers for heterogeneity of implant type and surgeon experience level, the editorialists said in the Annals of Internal Medicine.
The study is especially important, because ankle arthritis treatment is very understudied, compared with hip and knee arthritis, but it has a similar impact on activity, editorial coauthor Dr. Sangeorzan said in an interview.
“Randomized controlled trials are the gold standard for comparing medical therapies,” he said, “but they are very difficult to do in surgical treatments, particularly when the two treatments can be differentiated, in this case by movement of the ankle.”
In addition, there is a strong placebo effect attached to interventions, Dr. Sangeorzan noted. “Determining best-case treatment relies on prospective research, preferably randomized. Since both ankle fusion and ankle replacement are effective therapies, a prospective randomized trial is the best way to help make treatment decisions,” he said.
The current study findings are not surprising, but they are preliminary, and 1 year of follow-up is not enough to determine effectiveness, Dr. Sangeorzan emphasized. However, “the authors have done the hard work of randomizing the patients and collecting the data, and the patients can now be followed for a longer time,” he said.
“In addition, the trial was designed with multiple secondary outcome measures, so the data can be matched up with larger trials that were not randomized to identify key elements of success for each procedure,” he noted.
The key message for clinicians is that ankle arthritis has a significant impact on patients’ lives, but there are two effective treatments that can reduce the impact of the disease, said Dr. Sangeorzan. “The data suggest that there are differences in implant design and differences in comorbidities that should influence decision-making,” he added.
Additional research is needed in the form of a longer study duration with larger cohorts, said Dr. Sangeorzan. In particular, researchers need to determine what comorbidities might drive patients to one type of care vs. another, he said. “The suggestion that [patients receiving implants with two motion segments have better outcomes than those receiving implants with a one-motion segment] also deserves further study,” he added.
The research was supported by the UK National Institute for Health and Care Research Health Technology Assessment Programme. The trial was sponsored by University College London. Dr. Goldberg disclosed grant support from NIHR HTA, as well as financial relationships with companies including Stryker, Paragon 28, and stock options with Standing CT Company, Elstree Waterfront Outpatients, and X Bolt Orthopedics.
The editorialists had no financial conflicts to disclose.
Ankle osteoarthritis remains a cause of severe pain and disability. Patients are treated nonoperatively if possible, but surgery is often needed for individuals with end-stage disease, wrote Andrew Goldberg, MBBS, of University College London and colleagues in the Annals of Internal Medicine.
“Most patients with ankle arthritis respond to nonoperative treatments, such as weight loss, activity modification, support braces, and analgesia, [but] once the disease has progressed to end-stage osteoarthritis, the main surgical treatments are total ankle re-placement or ankle arthrodesis,” Dr. Goldberg said, in an interview.
In the new study, patients were randomized to receive either a total ankle replacement (TAR) or ankle fusion (AF).
“We showed that, in both treatment groups the clinical scores improved hugely, by more than three times the minimal clinically important difference,” Dr. Goldberg said in an interview.
“Although the ankle replacement arm improved, on average, by more than an extra 4 points over ankle fusion, this was not considered clinically or statistically significant,” he said.
The study is the first randomized trial to show high-quality and robust results, he noted, and findings support data from previous studies.
“Although both TAR and ankle fusion have been shown to be effective, they are very different treatments, with one fusing the bones so that there is no ankle joint movement, and the other replacing the joint with the aim of retaining ankle joint movement. It is difficult for a patient to know which treatment is more suitable for them, with most seeking guidance from their surgeon,” he said.
Generating high-quality evidence
The study, a randomized, multicenter, open-label trial known as TARVA (Total Ankle Replacement Versus Ankle Arthrodesis), aimed to compare the clinical effectiveness of the two existing publicly funded U.K. treatment options, the authors wrote.
Patients were recruited at 17 U.K. centers between March 6, 2015, and Jan. 10, 2019. The study enrolled 303 adults aged 50-85 years with end-stage ankle osteoarthritis. The mean age of the participants was 68 years; 71% were men. A total of 137 TAR patients and 144 ankle fusion patients completed their surgeries with clinical scores available for analysis. Baseline characteristics were mainly similar between the groups.
Blinding was not possible because of the nature of the procedures, but the surgeons who screened the patients were not aware of the randomization allocations, the researchers noted. A total of 33 surgeons participated in the trial, with a median number of seven patients per surgeon during the study period.
For TAR, U.K. surgeons use both two-component, fixed-bearing and three-component, mobile-bearing implants, the authors write. Ankle fusion was done using the surgeon’s usual technique of either arthroscopic-assisted or open ankle fusion.
The primary outcome was the change in the Manchester–Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores from baseline to 52 weeks after surgery. The MOXFQ-W/S uses a scale of 0-100, with lower scores representing better outcomes. Secondary outcomes included change in the MOXFQ-W/S scores at 26 weeks after surgery, as well as measures of patient quality of life.
No statistically significant difference
Overall, the mean MOXFQ-W/S scores improved significantly from baseline to 52 weeks for both groups, with average improvements of 49.9 in the TAR group and 44.4 points in the AF group. The average scores at 52 weeks were 31.4 in the TAR group and 36.8 in the AF group.
The adjusted difference in score change from baseline was –5.56, showing a slightly greater degree of improvement with TAR, but this difference was not clinically or statistically significant, the researchers noted.
Adverse event numbers were similar for both procedures, with 54% of TAR patients and 53% of AF patients experiencing at least 1 adverse event during the study period. Of those, 18% of TAR patients and 24% of AF patients experienced at least 1 serious adverse event.
However, the TAR patients experienced a higher rate of wound healing complications and nerve injuries, while thromboembolism was higher in the AF patients, the researchers noted.
A prespecified subgroup analysis of patients with osteoarthritis in adjacent joints suggested a greater improvement in TAR, compared with AF, a difference that increased when fixed-bearing TAR was compared with AF, the authors wrote.
“This reinforces previous reports that suggest that the presence of adjacent joint arthritis may be an indication for ankle replacement over AF,” the authors wrote in their discussion.
“Many of these patients did not have any symptoms in the adjacent joints,” they noted.
“The presence of adjacent joint arthritis, meaning the wear and tear of the joints around the ankle joint, seemed to favor ankle replacement,” Dr. Goldberg said. Approximately 30 joints in the foot continue to move after the ankle is fused, and if these adjacent joints are not healthy before surgery [as was the case in 42% of the study patients], the results of fusion were less successful, he explained.
A post hoc analysis between TAR subtypes showed that patients who had fixed-bearing TAR had significantly greater improvements, compared with AF patients, but this difference was not observed in patients who had mobile-bearing TAR, the researchers noted.
Dr. Goldberg said it was surprising “that, in a separate analysis, we found that the fixed-bearing ankle replacement patients [who accounted for half of the implants used] improved by a much greater difference when compared to ankle fusion.”
The study findings were limited by several factors including the short follow-up and study design that allowed surgeons to choose any implant and technique, the researchers noted.
Other limitations include a lack of data on cost-effectiveness and the impact of comorbidities on outcomes, they wrote. However, the study is the first completed multicenter randomized controlled trial to compare TAR and AF procedures for end-stage ankle osteoarthritis and shows that both yield similar clinical improvements, they concluded.
Data can inform treatment discussion
The take-home messages for clinicians are that both ankle replacement and ankle fusion are effective treatments that improve patients’ quality of life, and it is important to establish the health of adjacent joints before making treatment recommendations, Dr. Goldberg said.
“Careful counseling on the relative risks of each procedure should be part of the informed consent process,” he added. Ideally, all patients seeking surgical care for ankle arthritis should have a choice between ankle replacement and ankle fusion, but sometimes there is inequity of provision of the two treatments, he noted.
“We now encourage all surgeons to work in ankle arthritis networks so that every patient, no matter where they live, can have choice about the best treatment for them,” he said.
Researchers met the challenge of surgical RCT
Randomized trials of surgical interventions are challenging to conduct, and therefore limited, wrote Bruce Sangeorzan, MD, of the University of Washington, Seattle, and colleagues in an accompanying editorial. However, the new study was strengthened by the inclusion of 17 centers for heterogeneity of implant type and surgeon experience level, the editorialists said in the Annals of Internal Medicine.
The study is especially important, because ankle arthritis treatment is very understudied, compared with hip and knee arthritis, but it has a similar impact on activity, editorial coauthor Dr. Sangeorzan said in an interview.
“Randomized controlled trials are the gold standard for comparing medical therapies,” he said, “but they are very difficult to do in surgical treatments, particularly when the two treatments can be differentiated, in this case by movement of the ankle.”
In addition, there is a strong placebo effect attached to interventions, Dr. Sangeorzan noted. “Determining best-case treatment relies on prospective research, preferably randomized. Since both ankle fusion and ankle replacement are effective therapies, a prospective randomized trial is the best way to help make treatment decisions,” he said.
The current study findings are not surprising, but they are preliminary, and 1 year of follow-up is not enough to determine effectiveness, Dr. Sangeorzan emphasized. However, “the authors have done the hard work of randomizing the patients and collecting the data, and the patients can now be followed for a longer time,” he said.
“In addition, the trial was designed with multiple secondary outcome measures, so the data can be matched up with larger trials that were not randomized to identify key elements of success for each procedure,” he noted.
The key message for clinicians is that ankle arthritis has a significant impact on patients’ lives, but there are two effective treatments that can reduce the impact of the disease, said Dr. Sangeorzan. “The data suggest that there are differences in implant design and differences in comorbidities that should influence decision-making,” he added.
Additional research is needed in the form of a longer study duration with larger cohorts, said Dr. Sangeorzan. In particular, researchers need to determine what comorbidities might drive patients to one type of care vs. another, he said. “The suggestion that [patients receiving implants with two motion segments have better outcomes than those receiving implants with a one-motion segment] also deserves further study,” he added.
The research was supported by the UK National Institute for Health and Care Research Health Technology Assessment Programme. The trial was sponsored by University College London. Dr. Goldberg disclosed grant support from NIHR HTA, as well as financial relationships with companies including Stryker, Paragon 28, and stock options with Standing CT Company, Elstree Waterfront Outpatients, and X Bolt Orthopedics.
The editorialists had no financial conflicts to disclose.
Nutrition for cognition: A missed opportunity in U.S. seniors?
, new research shows. Researchers assessed the memory function of more than 3,500 persons who used SNAP or did not use SNAP over a period of 20 years. They found that those who didn’t use the food benefits program experienced 2 more years of cognitive aging compared with program users.
Of the 3,555 individuals included in the study, all were eligible to use the benefits, but only 559 did, leaving 2,996 participants who did not take advantage of the program.
Low program participation levels translate into a missed opportunity to prevent dementia, said study investigator Adina Zeki Al Hazzouri, PhD, assistant professor of epidemiology at the Columbia Aging Center at Columbia University Mailman School of Public Health in New York.
She said that prior research has shown that stigma may prevent older Americans from using SNAP. “Educational programs are needed to reduce the stigma that the public holds towards SNAP use,” she said.
Policy change could increase usage among older individuals, Dr. Zeki Al Hazzouri noted. Such changes could include simplifying enrollment and reporting procedures, shortening recertification periods, and increasing benefit levels.
The study was published online in Neurology.
Memory preservation
Dr. Zeki Al Hazzouri and her team assessed respondents from the Health and Retirement Study (HRS), a representative sample of Americans aged 50 and older. All respondents who were eligible to participate in SNAP in 1996 were followed every 2 years until 2016.
At each assessment, HRS respondents completed memory tests, including immediate and delayed word recall. For those who were too impaired to complete the interview, proxy informants – typically, their spouses or family members – assessed the memory and cognition of their family members using validated instruments, such as the 16-item Informant Questionnaire for Cognitive Decline.
Investigators used a validated memory function composite score, which is benchmarked against the memory assessments and evaluations of the Aging, Demographics, and Memory Study (ADAMS) cohort.
The team found that compared with nonusers, SNAP users were more likely to be women, Black, and born in the southern United States. They were less likely to be married and had more chronic conditions, such as high blood pressure, diabetes, cancer, heart problems, psychiatric problems, and arthritis.
One important study limitation was that SNAP use was measured only once during the study, the investigators noted. Ideally, Dr. Zeki Al Hazzouri said, future research would examine cumulative SNAP use history and explore the pathways that might account for the association between SNAP use and memory decline.
While findings suggest that there were no significant differences in baseline memory function between SNAP users and nonusers, users experienced approximately 2 fewer years of cognitive aging over a 10-year period than those who didn’t use the program.
Dr. Zeki Al Hazzouri speculated that SNAP benefits may slow cognitive aging by contributing to overall brain health and that, in comparison with nonusers, SNAP users absorb more nutrients, which promote neuronal integrity.
The investigators theorized that SNAP benefits may reduce stress from financial hardship, which has been linked to premature cognitive aging in other research.
“SNAP may also increase the purchasing power and investment in other health preserving behaviors, but also resulting in better access to care, which may in turn result in better disease management and management of risk factors for cognitive function,” the investigators wrote.
An underutilized program
In an accompanying editorial, Steven Albert, PhD, Philip B. Hallen Endowed Chair in Community Health and Social Justice at the University of Pittsburgh, noted that in 2020, among households with people aged 50 and older in the United States, more than 9 million Americans experienced food insecurity.
Furthermore, he pointed out, research from 2018 showed that 71% of people aged 60 and older who met income eligibility for SNAP did not participate in the program. “SNAP is an underutilized food security program involving substantial income supplements for older people with low incomes.
“Against the backdrop of so many failures of pharmacotherapy for dementia and the so far inexorable increase in the prevalence of dementia due to population aging, are we missing an opportunity to support cognitive health by failing to enroll the 14 million Americans who are over age 60 and eligible for SNAP but who do not participate?” Dr. Albert asked. He suggested that it would be helpful to determine this through a randomized promotion trial.
The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows. Researchers assessed the memory function of more than 3,500 persons who used SNAP or did not use SNAP over a period of 20 years. They found that those who didn’t use the food benefits program experienced 2 more years of cognitive aging compared with program users.
Of the 3,555 individuals included in the study, all were eligible to use the benefits, but only 559 did, leaving 2,996 participants who did not take advantage of the program.
Low program participation levels translate into a missed opportunity to prevent dementia, said study investigator Adina Zeki Al Hazzouri, PhD, assistant professor of epidemiology at the Columbia Aging Center at Columbia University Mailman School of Public Health in New York.
She said that prior research has shown that stigma may prevent older Americans from using SNAP. “Educational programs are needed to reduce the stigma that the public holds towards SNAP use,” she said.
Policy change could increase usage among older individuals, Dr. Zeki Al Hazzouri noted. Such changes could include simplifying enrollment and reporting procedures, shortening recertification periods, and increasing benefit levels.
The study was published online in Neurology.
Memory preservation
Dr. Zeki Al Hazzouri and her team assessed respondents from the Health and Retirement Study (HRS), a representative sample of Americans aged 50 and older. All respondents who were eligible to participate in SNAP in 1996 were followed every 2 years until 2016.
At each assessment, HRS respondents completed memory tests, including immediate and delayed word recall. For those who were too impaired to complete the interview, proxy informants – typically, their spouses or family members – assessed the memory and cognition of their family members using validated instruments, such as the 16-item Informant Questionnaire for Cognitive Decline.
Investigators used a validated memory function composite score, which is benchmarked against the memory assessments and evaluations of the Aging, Demographics, and Memory Study (ADAMS) cohort.
The team found that compared with nonusers, SNAP users were more likely to be women, Black, and born in the southern United States. They were less likely to be married and had more chronic conditions, such as high blood pressure, diabetes, cancer, heart problems, psychiatric problems, and arthritis.
One important study limitation was that SNAP use was measured only once during the study, the investigators noted. Ideally, Dr. Zeki Al Hazzouri said, future research would examine cumulative SNAP use history and explore the pathways that might account for the association between SNAP use and memory decline.
While findings suggest that there were no significant differences in baseline memory function between SNAP users and nonusers, users experienced approximately 2 fewer years of cognitive aging over a 10-year period than those who didn’t use the program.
Dr. Zeki Al Hazzouri speculated that SNAP benefits may slow cognitive aging by contributing to overall brain health and that, in comparison with nonusers, SNAP users absorb more nutrients, which promote neuronal integrity.
The investigators theorized that SNAP benefits may reduce stress from financial hardship, which has been linked to premature cognitive aging in other research.
“SNAP may also increase the purchasing power and investment in other health preserving behaviors, but also resulting in better access to care, which may in turn result in better disease management and management of risk factors for cognitive function,” the investigators wrote.
An underutilized program
In an accompanying editorial, Steven Albert, PhD, Philip B. Hallen Endowed Chair in Community Health and Social Justice at the University of Pittsburgh, noted that in 2020, among households with people aged 50 and older in the United States, more than 9 million Americans experienced food insecurity.
Furthermore, he pointed out, research from 2018 showed that 71% of people aged 60 and older who met income eligibility for SNAP did not participate in the program. “SNAP is an underutilized food security program involving substantial income supplements for older people with low incomes.
“Against the backdrop of so many failures of pharmacotherapy for dementia and the so far inexorable increase in the prevalence of dementia due to population aging, are we missing an opportunity to support cognitive health by failing to enroll the 14 million Americans who are over age 60 and eligible for SNAP but who do not participate?” Dr. Albert asked. He suggested that it would be helpful to determine this through a randomized promotion trial.
The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research shows. Researchers assessed the memory function of more than 3,500 persons who used SNAP or did not use SNAP over a period of 20 years. They found that those who didn’t use the food benefits program experienced 2 more years of cognitive aging compared with program users.
Of the 3,555 individuals included in the study, all were eligible to use the benefits, but only 559 did, leaving 2,996 participants who did not take advantage of the program.
Low program participation levels translate into a missed opportunity to prevent dementia, said study investigator Adina Zeki Al Hazzouri, PhD, assistant professor of epidemiology at the Columbia Aging Center at Columbia University Mailman School of Public Health in New York.
She said that prior research has shown that stigma may prevent older Americans from using SNAP. “Educational programs are needed to reduce the stigma that the public holds towards SNAP use,” she said.
Policy change could increase usage among older individuals, Dr. Zeki Al Hazzouri noted. Such changes could include simplifying enrollment and reporting procedures, shortening recertification periods, and increasing benefit levels.
The study was published online in Neurology.
Memory preservation
Dr. Zeki Al Hazzouri and her team assessed respondents from the Health and Retirement Study (HRS), a representative sample of Americans aged 50 and older. All respondents who were eligible to participate in SNAP in 1996 were followed every 2 years until 2016.
At each assessment, HRS respondents completed memory tests, including immediate and delayed word recall. For those who were too impaired to complete the interview, proxy informants – typically, their spouses or family members – assessed the memory and cognition of their family members using validated instruments, such as the 16-item Informant Questionnaire for Cognitive Decline.
Investigators used a validated memory function composite score, which is benchmarked against the memory assessments and evaluations of the Aging, Demographics, and Memory Study (ADAMS) cohort.
The team found that compared with nonusers, SNAP users were more likely to be women, Black, and born in the southern United States. They were less likely to be married and had more chronic conditions, such as high blood pressure, diabetes, cancer, heart problems, psychiatric problems, and arthritis.
One important study limitation was that SNAP use was measured only once during the study, the investigators noted. Ideally, Dr. Zeki Al Hazzouri said, future research would examine cumulative SNAP use history and explore the pathways that might account for the association between SNAP use and memory decline.
While findings suggest that there were no significant differences in baseline memory function between SNAP users and nonusers, users experienced approximately 2 fewer years of cognitive aging over a 10-year period than those who didn’t use the program.
Dr. Zeki Al Hazzouri speculated that SNAP benefits may slow cognitive aging by contributing to overall brain health and that, in comparison with nonusers, SNAP users absorb more nutrients, which promote neuronal integrity.
The investigators theorized that SNAP benefits may reduce stress from financial hardship, which has been linked to premature cognitive aging in other research.
“SNAP may also increase the purchasing power and investment in other health preserving behaviors, but also resulting in better access to care, which may in turn result in better disease management and management of risk factors for cognitive function,” the investigators wrote.
An underutilized program
In an accompanying editorial, Steven Albert, PhD, Philip B. Hallen Endowed Chair in Community Health and Social Justice at the University of Pittsburgh, noted that in 2020, among households with people aged 50 and older in the United States, more than 9 million Americans experienced food insecurity.
Furthermore, he pointed out, research from 2018 showed that 71% of people aged 60 and older who met income eligibility for SNAP did not participate in the program. “SNAP is an underutilized food security program involving substantial income supplements for older people with low incomes.
“Against the backdrop of so many failures of pharmacotherapy for dementia and the so far inexorable increase in the prevalence of dementia due to population aging, are we missing an opportunity to support cognitive health by failing to enroll the 14 million Americans who are over age 60 and eligible for SNAP but who do not participate?” Dr. Albert asked. He suggested that it would be helpful to determine this through a randomized promotion trial.
The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
From Neurology
Does subclinical hyperthyroidism raise fracture risk?
People with subclinical hyperthyroidism are at 34% greater risk of experiencing a fracture compared with those with normal thyroid function, new research shows.
The finding, from a study of nearly 11,000 middle-aged men and women followed for a median of 2 decades, “highlights a potential role for more aggressive screening and monitoring of patients with subclinical hyperthyroidism to prevent bone mineral disease,” the researchers wrote.
Primary care physicians “should be more aware of the risks for fracture among persons with subclinical hyperthyroidism in the ambulatory setting,” Natalie R. Daya, a PhD student in epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, and first author of the study, told this news organization.
Ms. Daya and her colleagues published their findings in JAMA Network Open.
Building on earlier findings
The results agree with previous work, including a meta-analysis of 13 prospective cohort studies of 70,289 primarily White individuals with an average age of 64 years, which found that subclinical hyperthyroidism was associated with a modestly increased risk for fractures, the researchers noted.
“Our study extends these findings to a younger, community-based cohort that included both Black and White participants, included extensive adjustment for potential confounders, and had a longer follow-up period (median follow-up of 21 years vs. 12 years),” they wrote.
The study included 10,946 participants in the Atherosclerosis Risk in Communities Study who were recruited in Washington County, Maryland; Forsyth County, North Carolina; Jackson, Mississippi; and the suburbs of Minneapolis.
Baseline thyroid function was measured in blood samples collected during the second visit, which occurred between 1990 and 1992. No participants in the new analysis took thyroid medications or had a history of hospitalization for fractures at baseline, and all identified as Black or White. The mean age was 57 years, 24% were Black, and 54.3% were female.
Subclinical hyperthyroidism was defined as a thyrotropin level less than 0.56 mIU/L; subclinical hypothyroidism as a thyrotropin level greater than 5.1 mIU/L; and normal thyroid function as a thyrotropin level between 0.56 and 5.1 mIU/L, with normal free thyroxine levels of 0.85-1.4 ng/dL.
The vast majority (93%) of participants had normal thyroid function, 2.6% had subclinical hyperthyroidism, and 4.4% had subclinical hypothyroidism, according to the researchers.
Median follow-up was 21 years. The researchers identified 3,556 incident fractures, detected with hospitalization discharge codes through 2019 and inpatient and Medicare claims data through 2018, for a rate of 167.1 per 10,000 person-years.
Adjusted hazard ratios for fracture were 1.34 (95% confidence interval [CI], 1.09-1.65) for people with subclinical hyperthyroidism and 0.90 (95% CI, 0.77-1.05) for those with subclinical hypothyroidism, compared with those with normal thyroid function.
Most fractures occurred in either the hip (14.1%) or spine (13.8%), according to the researchers.
Limitations included a lack of thyroid function data during the follow-up period and lack of data on bone mineral density, the researchers wrote.
‘An important risk factor’
Endocrinologist Michael McClung, MD, founding and emeritus director of the Oregon Osteoporosis Center, Portland, who was not involved in the study, pointed out that both subclinical hypothyroidism and subclinical hyperthyroidism have been linked to greater risk for cardiovascular disease as well as fracture.
The new paper underscores that subclinical hyperthyroidism “should be included as an important risk factor” for fracture as well as cardiovascular risk, Dr. McClung said in an interview. In considering whether to treat osteoporosis, subclinical hyperthyroidism “may be enough to tip the balance in favor of pharmacological therapy,” he added.
Thyroid-stimulating hormone (TSH) tests to assess thyroid function are typically ordered only if a patient has symptoms of hyperthyroidism or hypothyroidism, Ms. Daya said. Depending on the cause and severity of a low TSH level, a physician may prescribe methimazole or radioactive iodine therapy to reduce the production of thyroxine, she said.
However, well-designed studies are needed to evaluate whether treatment of subclinical thyroid dysfunction reduces the risk for fracture or cardiovascular problems and assess downsides such as side effects, costs, and psychological harm, Dr. McClung noted.
The U.S. Preventive Services Task Force concluded in 2015 that the data were insufficient to recommend screening for thyroid dysfunction in adults without symptoms. As of a year ago, no new evidence has emerged to support an update, according to the task force’s website.
“Until those studies are available, selective screening of thyroid function should be considered in all patients undergoing risk assessment for cardiovascular disease or skeletal health,” Dr. McClung said.
The Atherosclerosis Risk in Communities Study has been funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services. Ms. Daya and four study authors reported receiving NIH grants during the study period. Dr. McClung reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
People with subclinical hyperthyroidism are at 34% greater risk of experiencing a fracture compared with those with normal thyroid function, new research shows.
The finding, from a study of nearly 11,000 middle-aged men and women followed for a median of 2 decades, “highlights a potential role for more aggressive screening and monitoring of patients with subclinical hyperthyroidism to prevent bone mineral disease,” the researchers wrote.
Primary care physicians “should be more aware of the risks for fracture among persons with subclinical hyperthyroidism in the ambulatory setting,” Natalie R. Daya, a PhD student in epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, and first author of the study, told this news organization.
Ms. Daya and her colleagues published their findings in JAMA Network Open.
Building on earlier findings
The results agree with previous work, including a meta-analysis of 13 prospective cohort studies of 70,289 primarily White individuals with an average age of 64 years, which found that subclinical hyperthyroidism was associated with a modestly increased risk for fractures, the researchers noted.
“Our study extends these findings to a younger, community-based cohort that included both Black and White participants, included extensive adjustment for potential confounders, and had a longer follow-up period (median follow-up of 21 years vs. 12 years),” they wrote.
The study included 10,946 participants in the Atherosclerosis Risk in Communities Study who were recruited in Washington County, Maryland; Forsyth County, North Carolina; Jackson, Mississippi; and the suburbs of Minneapolis.
Baseline thyroid function was measured in blood samples collected during the second visit, which occurred between 1990 and 1992. No participants in the new analysis took thyroid medications or had a history of hospitalization for fractures at baseline, and all identified as Black or White. The mean age was 57 years, 24% were Black, and 54.3% were female.
Subclinical hyperthyroidism was defined as a thyrotropin level less than 0.56 mIU/L; subclinical hypothyroidism as a thyrotropin level greater than 5.1 mIU/L; and normal thyroid function as a thyrotropin level between 0.56 and 5.1 mIU/L, with normal free thyroxine levels of 0.85-1.4 ng/dL.
The vast majority (93%) of participants had normal thyroid function, 2.6% had subclinical hyperthyroidism, and 4.4% had subclinical hypothyroidism, according to the researchers.
Median follow-up was 21 years. The researchers identified 3,556 incident fractures, detected with hospitalization discharge codes through 2019 and inpatient and Medicare claims data through 2018, for a rate of 167.1 per 10,000 person-years.
Adjusted hazard ratios for fracture were 1.34 (95% confidence interval [CI], 1.09-1.65) for people with subclinical hyperthyroidism and 0.90 (95% CI, 0.77-1.05) for those with subclinical hypothyroidism, compared with those with normal thyroid function.
Most fractures occurred in either the hip (14.1%) or spine (13.8%), according to the researchers.
Limitations included a lack of thyroid function data during the follow-up period and lack of data on bone mineral density, the researchers wrote.
‘An important risk factor’
Endocrinologist Michael McClung, MD, founding and emeritus director of the Oregon Osteoporosis Center, Portland, who was not involved in the study, pointed out that both subclinical hypothyroidism and subclinical hyperthyroidism have been linked to greater risk for cardiovascular disease as well as fracture.
The new paper underscores that subclinical hyperthyroidism “should be included as an important risk factor” for fracture as well as cardiovascular risk, Dr. McClung said in an interview. In considering whether to treat osteoporosis, subclinical hyperthyroidism “may be enough to tip the balance in favor of pharmacological therapy,” he added.
Thyroid-stimulating hormone (TSH) tests to assess thyroid function are typically ordered only if a patient has symptoms of hyperthyroidism or hypothyroidism, Ms. Daya said. Depending on the cause and severity of a low TSH level, a physician may prescribe methimazole or radioactive iodine therapy to reduce the production of thyroxine, she said.
However, well-designed studies are needed to evaluate whether treatment of subclinical thyroid dysfunction reduces the risk for fracture or cardiovascular problems and assess downsides such as side effects, costs, and psychological harm, Dr. McClung noted.
The U.S. Preventive Services Task Force concluded in 2015 that the data were insufficient to recommend screening for thyroid dysfunction in adults without symptoms. As of a year ago, no new evidence has emerged to support an update, according to the task force’s website.
“Until those studies are available, selective screening of thyroid function should be considered in all patients undergoing risk assessment for cardiovascular disease or skeletal health,” Dr. McClung said.
The Atherosclerosis Risk in Communities Study has been funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services. Ms. Daya and four study authors reported receiving NIH grants during the study period. Dr. McClung reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
People with subclinical hyperthyroidism are at 34% greater risk of experiencing a fracture compared with those with normal thyroid function, new research shows.
The finding, from a study of nearly 11,000 middle-aged men and women followed for a median of 2 decades, “highlights a potential role for more aggressive screening and monitoring of patients with subclinical hyperthyroidism to prevent bone mineral disease,” the researchers wrote.
Primary care physicians “should be more aware of the risks for fracture among persons with subclinical hyperthyroidism in the ambulatory setting,” Natalie R. Daya, a PhD student in epidemiology at Johns Hopkins Bloomberg School of Public Health, Baltimore, and first author of the study, told this news organization.
Ms. Daya and her colleagues published their findings in JAMA Network Open.
Building on earlier findings
The results agree with previous work, including a meta-analysis of 13 prospective cohort studies of 70,289 primarily White individuals with an average age of 64 years, which found that subclinical hyperthyroidism was associated with a modestly increased risk for fractures, the researchers noted.
“Our study extends these findings to a younger, community-based cohort that included both Black and White participants, included extensive adjustment for potential confounders, and had a longer follow-up period (median follow-up of 21 years vs. 12 years),” they wrote.
The study included 10,946 participants in the Atherosclerosis Risk in Communities Study who were recruited in Washington County, Maryland; Forsyth County, North Carolina; Jackson, Mississippi; and the suburbs of Minneapolis.
Baseline thyroid function was measured in blood samples collected during the second visit, which occurred between 1990 and 1992. No participants in the new analysis took thyroid medications or had a history of hospitalization for fractures at baseline, and all identified as Black or White. The mean age was 57 years, 24% were Black, and 54.3% were female.
Subclinical hyperthyroidism was defined as a thyrotropin level less than 0.56 mIU/L; subclinical hypothyroidism as a thyrotropin level greater than 5.1 mIU/L; and normal thyroid function as a thyrotropin level between 0.56 and 5.1 mIU/L, with normal free thyroxine levels of 0.85-1.4 ng/dL.
The vast majority (93%) of participants had normal thyroid function, 2.6% had subclinical hyperthyroidism, and 4.4% had subclinical hypothyroidism, according to the researchers.
Median follow-up was 21 years. The researchers identified 3,556 incident fractures, detected with hospitalization discharge codes through 2019 and inpatient and Medicare claims data through 2018, for a rate of 167.1 per 10,000 person-years.
Adjusted hazard ratios for fracture were 1.34 (95% confidence interval [CI], 1.09-1.65) for people with subclinical hyperthyroidism and 0.90 (95% CI, 0.77-1.05) for those with subclinical hypothyroidism, compared with those with normal thyroid function.
Most fractures occurred in either the hip (14.1%) or spine (13.8%), according to the researchers.
Limitations included a lack of thyroid function data during the follow-up period and lack of data on bone mineral density, the researchers wrote.
‘An important risk factor’
Endocrinologist Michael McClung, MD, founding and emeritus director of the Oregon Osteoporosis Center, Portland, who was not involved in the study, pointed out that both subclinical hypothyroidism and subclinical hyperthyroidism have been linked to greater risk for cardiovascular disease as well as fracture.
The new paper underscores that subclinical hyperthyroidism “should be included as an important risk factor” for fracture as well as cardiovascular risk, Dr. McClung said in an interview. In considering whether to treat osteoporosis, subclinical hyperthyroidism “may be enough to tip the balance in favor of pharmacological therapy,” he added.
Thyroid-stimulating hormone (TSH) tests to assess thyroid function are typically ordered only if a patient has symptoms of hyperthyroidism or hypothyroidism, Ms. Daya said. Depending on the cause and severity of a low TSH level, a physician may prescribe methimazole or radioactive iodine therapy to reduce the production of thyroxine, she said.
However, well-designed studies are needed to evaluate whether treatment of subclinical thyroid dysfunction reduces the risk for fracture or cardiovascular problems and assess downsides such as side effects, costs, and psychological harm, Dr. McClung noted.
The U.S. Preventive Services Task Force concluded in 2015 that the data were insufficient to recommend screening for thyroid dysfunction in adults without symptoms. As of a year ago, no new evidence has emerged to support an update, according to the task force’s website.
“Until those studies are available, selective screening of thyroid function should be considered in all patients undergoing risk assessment for cardiovascular disease or skeletal health,” Dr. McClung said.
The Atherosclerosis Risk in Communities Study has been funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services. Ms. Daya and four study authors reported receiving NIH grants during the study period. Dr. McClung reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Daily aspirin fails to reduce risk of fractures in older adults
Previous research suggests that aspirin may reduce the risk of fragility fractures by delaying bone loss, but the direct effects of aspirin on bone microarchitecture and the association between aspirin use and fracture risk in humans has not been explored, corresponding author Anna L. Barker, PhD, and colleagues wrote in their paper published in JAMA Internal Medicine.
Dr. Barker, who is executive director of research and innovation for Silverchain (a senior care program), said, in an interview, that she and her coauthors hypothesized “that aspirin could reduce both falls and fractures by reducing cardiovascular-associated physical and cognitive impairments and the anti-inflammatory properties mediating bone remodeling.”
Study methods and results
In the ASPREE-FRACTURE substudy, the authors examined the impact of daily low-dose aspirin (100 mg) on incidence of any fracture in more than 16,000 community-dwelling adults aged 70 years and older. A secondary endpoint was the incidence of serious falls, defined as falls requiring a hospital visit. Individuals with chronic illness and cardiovascular or cerebrovascular disease were excluded, as were those with dementia or other cognitive impairment, or a physical disability.
The study population included 16,703 participants enrolled in the larger Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial between 2010 and 2014. Of these, 8,322 were randomized to aspirin and 8,381 to a placebo. The median age was 74 years, and 55% of the participants were women.
Over a median follow-up of 4.6 years (76,219 total person-years), the risk of first fracture was similar between the aspirin and placebo groups (hazard ratio, 0.97), but the risk of serious falls was significantly higher in the aspirin group (884 falls vs. 804 falls, P = .01).
The incidence of first fracture was similar between the aspirin and placebo groups (813 vs. 718), as was the incidence of all fractures (1,394 and 1,471, respectively).
The results for both fractures and falls were essentially unchanged in a multivariate analysis controlling for variables known to affect fracture and fall risk and remained similar for different types of fractures (hip, trauma-related, nonpathological) as well, the researchers noted.
In their discussion, the researchers wrote that the clinical significance of the study is the inability of aspirin to reduce the risk of fractures in otherwise healthy older adults. They expressed surprise at the increase in serious falls, citing their hypothesis that the antiplatelet effects of aspirin may reduce cardiovascular and cerebrovascular events, thereby slowing physical decline and decreasing fall risk.
The increased risk of serious falls was not accompanied by an increase in fractures, and the increased fall risk was similar across subgroups of aspirin users, the researchers said.
Low-dose aspirin’s failure to reduce the risk of fractures but increasing the risk of serious falls adds to evidence that this agent provides little favorable benefit in a healthy, White older adult population.
The study findings were limited by several factors including the relatively homogeneous older and healthy population, and possible insufficient study duration to allow for changes in fracture and fall risk, the researchers noted. Other potential limitations include that the dose of aspirin used in the study was too low to affect bone remodeling and the lack of data on bone density, rheumatoid arthritis, and osteoporosis, they said.
However, the results were strengthened by the large sample size and high participant retention rate, and represent the first known examination of data from a randomized, controlled trial of the effect of aspirin on fractures, they added.
Setting the stage for more research
Overall, “This study adds to the growing body of evidence from other studies that the use of aspirin in people who do not have a risk of cardiovascular disease or stroke provides little benefit,” said Dr. Barker, who is also a professor at Monash University, Melbourne, Australia. However, “Older adults with a medical reason to take aspirin should continue to do so,” she emphasized.
“The most important thing the study showed is the primary endpoint, which was that aspirin use does not have an effect on fracture risk,” said Neil Skolnik, MD, of Sidney Kimmel Medical College, Philadelphia, in an interview.
“The increase in serious falls, as defined by a fall resulting in a visit to a hospital, is likely due to an increased risk of bleeding after a fall on aspirin,” said Dr. Skolnik, who was not involved in the study. Dr. Skolnik added that the current study findings support the current recommendations of the United States Preventive Services Task Force, which he quoted as follows, “The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older.”
The study was supported by the National Institute on Aging and the National Cancer Institute at the National Institutes of Health; the National Health and Medical Research Council (Australia); Monash University; and the Victorian Cancer Agency. Lead author Dr. Barker was supported in part by the NHMRC and also disclosed grants from the NHMRC outside the current study. The ASPREE substudy also was supported by the University of Pittsburgh Claude D. Pepper Older American Independence Center and the Wake Forest University Claude D. Pepper Older Americans Independence Center. Bayer AG provided the aspirin used in the study but had no other role. Dr. Skolnik had no financial conflicts to disclose, but he serves on the editorial advisory board of Family Practice News.
Previous research suggests that aspirin may reduce the risk of fragility fractures by delaying bone loss, but the direct effects of aspirin on bone microarchitecture and the association between aspirin use and fracture risk in humans has not been explored, corresponding author Anna L. Barker, PhD, and colleagues wrote in their paper published in JAMA Internal Medicine.
Dr. Barker, who is executive director of research and innovation for Silverchain (a senior care program), said, in an interview, that she and her coauthors hypothesized “that aspirin could reduce both falls and fractures by reducing cardiovascular-associated physical and cognitive impairments and the anti-inflammatory properties mediating bone remodeling.”
Study methods and results
In the ASPREE-FRACTURE substudy, the authors examined the impact of daily low-dose aspirin (100 mg) on incidence of any fracture in more than 16,000 community-dwelling adults aged 70 years and older. A secondary endpoint was the incidence of serious falls, defined as falls requiring a hospital visit. Individuals with chronic illness and cardiovascular or cerebrovascular disease were excluded, as were those with dementia or other cognitive impairment, or a physical disability.
The study population included 16,703 participants enrolled in the larger Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial between 2010 and 2014. Of these, 8,322 were randomized to aspirin and 8,381 to a placebo. The median age was 74 years, and 55% of the participants were women.
Over a median follow-up of 4.6 years (76,219 total person-years), the risk of first fracture was similar between the aspirin and placebo groups (hazard ratio, 0.97), but the risk of serious falls was significantly higher in the aspirin group (884 falls vs. 804 falls, P = .01).
The incidence of first fracture was similar between the aspirin and placebo groups (813 vs. 718), as was the incidence of all fractures (1,394 and 1,471, respectively).
The results for both fractures and falls were essentially unchanged in a multivariate analysis controlling for variables known to affect fracture and fall risk and remained similar for different types of fractures (hip, trauma-related, nonpathological) as well, the researchers noted.
In their discussion, the researchers wrote that the clinical significance of the study is the inability of aspirin to reduce the risk of fractures in otherwise healthy older adults. They expressed surprise at the increase in serious falls, citing their hypothesis that the antiplatelet effects of aspirin may reduce cardiovascular and cerebrovascular events, thereby slowing physical decline and decreasing fall risk.
The increased risk of serious falls was not accompanied by an increase in fractures, and the increased fall risk was similar across subgroups of aspirin users, the researchers said.
Low-dose aspirin’s failure to reduce the risk of fractures but increasing the risk of serious falls adds to evidence that this agent provides little favorable benefit in a healthy, White older adult population.
The study findings were limited by several factors including the relatively homogeneous older and healthy population, and possible insufficient study duration to allow for changes in fracture and fall risk, the researchers noted. Other potential limitations include that the dose of aspirin used in the study was too low to affect bone remodeling and the lack of data on bone density, rheumatoid arthritis, and osteoporosis, they said.
However, the results were strengthened by the large sample size and high participant retention rate, and represent the first known examination of data from a randomized, controlled trial of the effect of aspirin on fractures, they added.
Setting the stage for more research
Overall, “This study adds to the growing body of evidence from other studies that the use of aspirin in people who do not have a risk of cardiovascular disease or stroke provides little benefit,” said Dr. Barker, who is also a professor at Monash University, Melbourne, Australia. However, “Older adults with a medical reason to take aspirin should continue to do so,” she emphasized.
“The most important thing the study showed is the primary endpoint, which was that aspirin use does not have an effect on fracture risk,” said Neil Skolnik, MD, of Sidney Kimmel Medical College, Philadelphia, in an interview.
“The increase in serious falls, as defined by a fall resulting in a visit to a hospital, is likely due to an increased risk of bleeding after a fall on aspirin,” said Dr. Skolnik, who was not involved in the study. Dr. Skolnik added that the current study findings support the current recommendations of the United States Preventive Services Task Force, which he quoted as follows, “The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older.”
The study was supported by the National Institute on Aging and the National Cancer Institute at the National Institutes of Health; the National Health and Medical Research Council (Australia); Monash University; and the Victorian Cancer Agency. Lead author Dr. Barker was supported in part by the NHMRC and also disclosed grants from the NHMRC outside the current study. The ASPREE substudy also was supported by the University of Pittsburgh Claude D. Pepper Older American Independence Center and the Wake Forest University Claude D. Pepper Older Americans Independence Center. Bayer AG provided the aspirin used in the study but had no other role. Dr. Skolnik had no financial conflicts to disclose, but he serves on the editorial advisory board of Family Practice News.
Previous research suggests that aspirin may reduce the risk of fragility fractures by delaying bone loss, but the direct effects of aspirin on bone microarchitecture and the association between aspirin use and fracture risk in humans has not been explored, corresponding author Anna L. Barker, PhD, and colleagues wrote in their paper published in JAMA Internal Medicine.
Dr. Barker, who is executive director of research and innovation for Silverchain (a senior care program), said, in an interview, that she and her coauthors hypothesized “that aspirin could reduce both falls and fractures by reducing cardiovascular-associated physical and cognitive impairments and the anti-inflammatory properties mediating bone remodeling.”
Study methods and results
In the ASPREE-FRACTURE substudy, the authors examined the impact of daily low-dose aspirin (100 mg) on incidence of any fracture in more than 16,000 community-dwelling adults aged 70 years and older. A secondary endpoint was the incidence of serious falls, defined as falls requiring a hospital visit. Individuals with chronic illness and cardiovascular or cerebrovascular disease were excluded, as were those with dementia or other cognitive impairment, or a physical disability.
The study population included 16,703 participants enrolled in the larger Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial between 2010 and 2014. Of these, 8,322 were randomized to aspirin and 8,381 to a placebo. The median age was 74 years, and 55% of the participants were women.
Over a median follow-up of 4.6 years (76,219 total person-years), the risk of first fracture was similar between the aspirin and placebo groups (hazard ratio, 0.97), but the risk of serious falls was significantly higher in the aspirin group (884 falls vs. 804 falls, P = .01).
The incidence of first fracture was similar between the aspirin and placebo groups (813 vs. 718), as was the incidence of all fractures (1,394 and 1,471, respectively).
The results for both fractures and falls were essentially unchanged in a multivariate analysis controlling for variables known to affect fracture and fall risk and remained similar for different types of fractures (hip, trauma-related, nonpathological) as well, the researchers noted.
In their discussion, the researchers wrote that the clinical significance of the study is the inability of aspirin to reduce the risk of fractures in otherwise healthy older adults. They expressed surprise at the increase in serious falls, citing their hypothesis that the antiplatelet effects of aspirin may reduce cardiovascular and cerebrovascular events, thereby slowing physical decline and decreasing fall risk.
The increased risk of serious falls was not accompanied by an increase in fractures, and the increased fall risk was similar across subgroups of aspirin users, the researchers said.
Low-dose aspirin’s failure to reduce the risk of fractures but increasing the risk of serious falls adds to evidence that this agent provides little favorable benefit in a healthy, White older adult population.
The study findings were limited by several factors including the relatively homogeneous older and healthy population, and possible insufficient study duration to allow for changes in fracture and fall risk, the researchers noted. Other potential limitations include that the dose of aspirin used in the study was too low to affect bone remodeling and the lack of data on bone density, rheumatoid arthritis, and osteoporosis, they said.
However, the results were strengthened by the large sample size and high participant retention rate, and represent the first known examination of data from a randomized, controlled trial of the effect of aspirin on fractures, they added.
Setting the stage for more research
Overall, “This study adds to the growing body of evidence from other studies that the use of aspirin in people who do not have a risk of cardiovascular disease or stroke provides little benefit,” said Dr. Barker, who is also a professor at Monash University, Melbourne, Australia. However, “Older adults with a medical reason to take aspirin should continue to do so,” she emphasized.
“The most important thing the study showed is the primary endpoint, which was that aspirin use does not have an effect on fracture risk,” said Neil Skolnik, MD, of Sidney Kimmel Medical College, Philadelphia, in an interview.
“The increase in serious falls, as defined by a fall resulting in a visit to a hospital, is likely due to an increased risk of bleeding after a fall on aspirin,” said Dr. Skolnik, who was not involved in the study. Dr. Skolnik added that the current study findings support the current recommendations of the United States Preventive Services Task Force, which he quoted as follows, “The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older.”
The study was supported by the National Institute on Aging and the National Cancer Institute at the National Institutes of Health; the National Health and Medical Research Council (Australia); Monash University; and the Victorian Cancer Agency. Lead author Dr. Barker was supported in part by the NHMRC and also disclosed grants from the NHMRC outside the current study. The ASPREE substudy also was supported by the University of Pittsburgh Claude D. Pepper Older American Independence Center and the Wake Forest University Claude D. Pepper Older Americans Independence Center. Bayer AG provided the aspirin used in the study but had no other role. Dr. Skolnik had no financial conflicts to disclose, but he serves on the editorial advisory board of Family Practice News.
FROM JAMA INTERNAL MEDICINE
Novel drug eases Parkinson’s-related constipation in early trial
The findings are based on 135 patients who completed 7-25 days of treatment with a daily oral dose of the drug, ENT-01, or a placebo. Complete spontaneous bowel movements (CSBMs), the primary efficacy endpoint, increased from a mean of 0.7 per week to 3.2 in individuals who took ENT-01 versus 1.2 in the placebo group.
The phase 2, multicenter, randomized trial showed that the drug “is safe and that it rapidly normalized bowel function in a dose-dependent fashion, with an effect that seems to persist for several weeks beyond the treatment period,” the researchers wrote in their paper on the research, which was published in Annals of Internal Medicine.
The researchers hypothesized that displacing aggregated alpha-synuclein from nerve cells in the gastrointestinal tract may also “slow progression of neurologic symptoms” in patients with PD by arresting the abnormal development of alpha-nucleic aggregates in the brain.
Denise Barbut, MD, cofounder, president and chief medical officer of Enterin, the company developing ENT-01, said the next step is another phase 2 trial to determine whether the drug reverses dementia or psychosis in patients with PD, before conducting a phase 3 study.
“We want to treat all nonmotor symptoms of Parkinson’s disease, not just constipation,” she said.
Constipation is an early PD symptom
Constipation is a common and persistent symptom of PD that often emerges years earlier than other symptoms such as motor deficits. Recent research has linked it to aggregates of alpha-synuclein that bind to cells in the enteric nervous system and may spread to the brain via the vagus nerve.
According to the researchers, ENT-01, a synthetic derivative of the antimicrobial compound squalamine, improves neural signaling in the gut by displacing alpha-synuclein aggregates.
In their double-blinded study, patients were randomized 3:1 to receive ENT-01 or a placebo and stratified by constipation severity to one of two starting doses: 75 mg or three placebo pills or 150 mg or six placebo pills. Doses increased until a patient reached a “prokinetic” dose, a maximum of 250 mg or 10 placebo pills, or the individual’s tolerability limit.
Dosing was fixed for the remainder of the 25 days, after which all patients took a placebo for 2 weeks followed by a 4-week washout.
In addition to more CSBMs, the treatment group had greater improvements in secondary endpoints of weekly spontaneous bowel movements (P = .002), better stool consistency (P < .001), improved ease of passage (P = .006), and less laxative use (P = .041).
There were no significant differences between the groups in scores on the Patient Assessment of Constipation Symptoms or the Patient Assessment of Constipation Quality of Life.
No deaths occurred, and there were no serious adverse events attributed to ENT-01. However, adverse events occurred in 61 (65.6%) of patients who took the drug versus 27 (47.4%) of those who took a placebo.
The most common problems were nausea, experienced by 32 (34%) in the ENT-01 group and 3 (5.3%) in the placebo group, and diarrhea, which occurred in 18 (9.4%) of those in the ENT-01 group and three (5.3%) who took the placebo.
Of 93 patients randomized to the drug (25.8%), 24 discontinued treatment before therapy ended, mostly because of nausea or diarrhea. That compared with 8 of 57 (14.1%) patients in the placebo group who stopped taking their pills before the end of the therapy period.
The researchers suggested that nausea and diarrhea might be alleviated by more gradual dosing escalation and the use of antinausea medication.
Dr. Barbut noted that a previous open-label trial of 50 patients with PD showed that ENT-01 acts locally in the gastrointestinal tract, which means it would not be absorbed into the bloodstream or interfere with other medications.
Targeting the underlying disease
Researchers noted that, in small subsets of patients with dementia or psychosis, greater improvements in those symptoms occurred among those who took ENT-01 versus those who took a placebo.
According to the study, among 11 patients with psychosis, average scores on the Scale for the Assessment of Positive Symptoms adapted for PD dropped from 6.5 to 1.8 on a 45-point scale at the end of treatment in the ENT-01 group (n = 5) and from 6.3 to 3.4 in the placebo group (n = 6).
In 28 patients with dementia, scores on the Mini-Mental State Examination improved by 2.4 points on a 30-point scale, from 24.1 to 26.5, during the treatment period for the ENT-01 group (n = 14) versus an improvement of 0.9 points, from 24.8 to 25.7, in the placebo group (n = 14).
The researchers said the findings must be evaluated in future trials dedicated to studying ENT-01’s effects on PD-related psychosis and dementia.
He added that, if findings are reproduced in a large study, the drug could have “a major impact” not just in treating constipation, for which there are no PD-specific drugs, but also in addressing neurological dysfunctions that are cardinal features of PD. “That is what is exciting to me, because we’re now talking about reversing the disease itself,” he said.
However, Dr. Barbut said it’s been difficult to get across to the medical community and to investors that a drug that acts on nerve cells in the gut might reverse neurologic symptoms by improving direct gut-brain communication. “That’s a concept that is alien to most people’s thinking,” she said.
Enterin funded the study and was responsible for the design, data collection and analysis. Its employees also participated in the interpretation of data, writing of the report, and the decision to submit the manuscript for publication. Dr. Barbut reported stock options in Enterin and patent interests in ENT-01. Fifteen other study investigators reported financial ties to Enterin and/or ENT-01 including employment, stock options, research funding, consulting fees and patent application ownership. Dr. Rao reported receiving honoraria from multiple companies that market drugs for general constipation.
The findings are based on 135 patients who completed 7-25 days of treatment with a daily oral dose of the drug, ENT-01, or a placebo. Complete spontaneous bowel movements (CSBMs), the primary efficacy endpoint, increased from a mean of 0.7 per week to 3.2 in individuals who took ENT-01 versus 1.2 in the placebo group.
The phase 2, multicenter, randomized trial showed that the drug “is safe and that it rapidly normalized bowel function in a dose-dependent fashion, with an effect that seems to persist for several weeks beyond the treatment period,” the researchers wrote in their paper on the research, which was published in Annals of Internal Medicine.
The researchers hypothesized that displacing aggregated alpha-synuclein from nerve cells in the gastrointestinal tract may also “slow progression of neurologic symptoms” in patients with PD by arresting the abnormal development of alpha-nucleic aggregates in the brain.
Denise Barbut, MD, cofounder, president and chief medical officer of Enterin, the company developing ENT-01, said the next step is another phase 2 trial to determine whether the drug reverses dementia or psychosis in patients with PD, before conducting a phase 3 study.
“We want to treat all nonmotor symptoms of Parkinson’s disease, not just constipation,” she said.
Constipation is an early PD symptom
Constipation is a common and persistent symptom of PD that often emerges years earlier than other symptoms such as motor deficits. Recent research has linked it to aggregates of alpha-synuclein that bind to cells in the enteric nervous system and may spread to the brain via the vagus nerve.
According to the researchers, ENT-01, a synthetic derivative of the antimicrobial compound squalamine, improves neural signaling in the gut by displacing alpha-synuclein aggregates.
In their double-blinded study, patients were randomized 3:1 to receive ENT-01 or a placebo and stratified by constipation severity to one of two starting doses: 75 mg or three placebo pills or 150 mg or six placebo pills. Doses increased until a patient reached a “prokinetic” dose, a maximum of 250 mg or 10 placebo pills, or the individual’s tolerability limit.
Dosing was fixed for the remainder of the 25 days, after which all patients took a placebo for 2 weeks followed by a 4-week washout.
In addition to more CSBMs, the treatment group had greater improvements in secondary endpoints of weekly spontaneous bowel movements (P = .002), better stool consistency (P < .001), improved ease of passage (P = .006), and less laxative use (P = .041).
There were no significant differences between the groups in scores on the Patient Assessment of Constipation Symptoms or the Patient Assessment of Constipation Quality of Life.
No deaths occurred, and there were no serious adverse events attributed to ENT-01. However, adverse events occurred in 61 (65.6%) of patients who took the drug versus 27 (47.4%) of those who took a placebo.
The most common problems were nausea, experienced by 32 (34%) in the ENT-01 group and 3 (5.3%) in the placebo group, and diarrhea, which occurred in 18 (9.4%) of those in the ENT-01 group and three (5.3%) who took the placebo.
Of 93 patients randomized to the drug (25.8%), 24 discontinued treatment before therapy ended, mostly because of nausea or diarrhea. That compared with 8 of 57 (14.1%) patients in the placebo group who stopped taking their pills before the end of the therapy period.
The researchers suggested that nausea and diarrhea might be alleviated by more gradual dosing escalation and the use of antinausea medication.
Dr. Barbut noted that a previous open-label trial of 50 patients with PD showed that ENT-01 acts locally in the gastrointestinal tract, which means it would not be absorbed into the bloodstream or interfere with other medications.
Targeting the underlying disease
Researchers noted that, in small subsets of patients with dementia or psychosis, greater improvements in those symptoms occurred among those who took ENT-01 versus those who took a placebo.
According to the study, among 11 patients with psychosis, average scores on the Scale for the Assessment of Positive Symptoms adapted for PD dropped from 6.5 to 1.8 on a 45-point scale at the end of treatment in the ENT-01 group (n = 5) and from 6.3 to 3.4 in the placebo group (n = 6).
In 28 patients with dementia, scores on the Mini-Mental State Examination improved by 2.4 points on a 30-point scale, from 24.1 to 26.5, during the treatment period for the ENT-01 group (n = 14) versus an improvement of 0.9 points, from 24.8 to 25.7, in the placebo group (n = 14).
The researchers said the findings must be evaluated in future trials dedicated to studying ENT-01’s effects on PD-related psychosis and dementia.
He added that, if findings are reproduced in a large study, the drug could have “a major impact” not just in treating constipation, for which there are no PD-specific drugs, but also in addressing neurological dysfunctions that are cardinal features of PD. “That is what is exciting to me, because we’re now talking about reversing the disease itself,” he said.
However, Dr. Barbut said it’s been difficult to get across to the medical community and to investors that a drug that acts on nerve cells in the gut might reverse neurologic symptoms by improving direct gut-brain communication. “That’s a concept that is alien to most people’s thinking,” she said.
Enterin funded the study and was responsible for the design, data collection and analysis. Its employees also participated in the interpretation of data, writing of the report, and the decision to submit the manuscript for publication. Dr. Barbut reported stock options in Enterin and patent interests in ENT-01. Fifteen other study investigators reported financial ties to Enterin and/or ENT-01 including employment, stock options, research funding, consulting fees and patent application ownership. Dr. Rao reported receiving honoraria from multiple companies that market drugs for general constipation.
The findings are based on 135 patients who completed 7-25 days of treatment with a daily oral dose of the drug, ENT-01, or a placebo. Complete spontaneous bowel movements (CSBMs), the primary efficacy endpoint, increased from a mean of 0.7 per week to 3.2 in individuals who took ENT-01 versus 1.2 in the placebo group.
The phase 2, multicenter, randomized trial showed that the drug “is safe and that it rapidly normalized bowel function in a dose-dependent fashion, with an effect that seems to persist for several weeks beyond the treatment period,” the researchers wrote in their paper on the research, which was published in Annals of Internal Medicine.
The researchers hypothesized that displacing aggregated alpha-synuclein from nerve cells in the gastrointestinal tract may also “slow progression of neurologic symptoms” in patients with PD by arresting the abnormal development of alpha-nucleic aggregates in the brain.
Denise Barbut, MD, cofounder, president and chief medical officer of Enterin, the company developing ENT-01, said the next step is another phase 2 trial to determine whether the drug reverses dementia or psychosis in patients with PD, before conducting a phase 3 study.
“We want to treat all nonmotor symptoms of Parkinson’s disease, not just constipation,” she said.
Constipation is an early PD symptom
Constipation is a common and persistent symptom of PD that often emerges years earlier than other symptoms such as motor deficits. Recent research has linked it to aggregates of alpha-synuclein that bind to cells in the enteric nervous system and may spread to the brain via the vagus nerve.
According to the researchers, ENT-01, a synthetic derivative of the antimicrobial compound squalamine, improves neural signaling in the gut by displacing alpha-synuclein aggregates.
In their double-blinded study, patients were randomized 3:1 to receive ENT-01 or a placebo and stratified by constipation severity to one of two starting doses: 75 mg or three placebo pills or 150 mg or six placebo pills. Doses increased until a patient reached a “prokinetic” dose, a maximum of 250 mg or 10 placebo pills, or the individual’s tolerability limit.
Dosing was fixed for the remainder of the 25 days, after which all patients took a placebo for 2 weeks followed by a 4-week washout.
In addition to more CSBMs, the treatment group had greater improvements in secondary endpoints of weekly spontaneous bowel movements (P = .002), better stool consistency (P < .001), improved ease of passage (P = .006), and less laxative use (P = .041).
There were no significant differences between the groups in scores on the Patient Assessment of Constipation Symptoms or the Patient Assessment of Constipation Quality of Life.
No deaths occurred, and there were no serious adverse events attributed to ENT-01. However, adverse events occurred in 61 (65.6%) of patients who took the drug versus 27 (47.4%) of those who took a placebo.
The most common problems were nausea, experienced by 32 (34%) in the ENT-01 group and 3 (5.3%) in the placebo group, and diarrhea, which occurred in 18 (9.4%) of those in the ENT-01 group and three (5.3%) who took the placebo.
Of 93 patients randomized to the drug (25.8%), 24 discontinued treatment before therapy ended, mostly because of nausea or diarrhea. That compared with 8 of 57 (14.1%) patients in the placebo group who stopped taking their pills before the end of the therapy period.
The researchers suggested that nausea and diarrhea might be alleviated by more gradual dosing escalation and the use of antinausea medication.
Dr. Barbut noted that a previous open-label trial of 50 patients with PD showed that ENT-01 acts locally in the gastrointestinal tract, which means it would not be absorbed into the bloodstream or interfere with other medications.
Targeting the underlying disease
Researchers noted that, in small subsets of patients with dementia or psychosis, greater improvements in those symptoms occurred among those who took ENT-01 versus those who took a placebo.
According to the study, among 11 patients with psychosis, average scores on the Scale for the Assessment of Positive Symptoms adapted for PD dropped from 6.5 to 1.8 on a 45-point scale at the end of treatment in the ENT-01 group (n = 5) and from 6.3 to 3.4 in the placebo group (n = 6).
In 28 patients with dementia, scores on the Mini-Mental State Examination improved by 2.4 points on a 30-point scale, from 24.1 to 26.5, during the treatment period for the ENT-01 group (n = 14) versus an improvement of 0.9 points, from 24.8 to 25.7, in the placebo group (n = 14).
The researchers said the findings must be evaluated in future trials dedicated to studying ENT-01’s effects on PD-related psychosis and dementia.
He added that, if findings are reproduced in a large study, the drug could have “a major impact” not just in treating constipation, for which there are no PD-specific drugs, but also in addressing neurological dysfunctions that are cardinal features of PD. “That is what is exciting to me, because we’re now talking about reversing the disease itself,” he said.
However, Dr. Barbut said it’s been difficult to get across to the medical community and to investors that a drug that acts on nerve cells in the gut might reverse neurologic symptoms by improving direct gut-brain communication. “That’s a concept that is alien to most people’s thinking,” she said.
Enterin funded the study and was responsible for the design, data collection and analysis. Its employees also participated in the interpretation of data, writing of the report, and the decision to submit the manuscript for publication. Dr. Barbut reported stock options in Enterin and patent interests in ENT-01. Fifteen other study investigators reported financial ties to Enterin and/or ENT-01 including employment, stock options, research funding, consulting fees and patent application ownership. Dr. Rao reported receiving honoraria from multiple companies that market drugs for general constipation.
FROM ANNALS OF INTERNAL MEDICINE
Sexual activities in seniors: Experts advise on what to ask
Sexual activity in older adults is something of a taboo, rarely discussed and largely ignored by researchers.
But failing to address human sexuality in old age can lead doctors to ask seniors the wrong questions about sex – if they ask at all.
When researchers do look at the issue, they find surprises, as Janie Steckenrider, PhD, has learned. In a new study presented at the annual scientific meeting of the Gerontological Society of America, Dr. Steckenrider, a professor of political science at Loyola Marymount University, Los Angeles, found that previous attempts to qualify the sexual activities of seniors appear to be limited largely to partnered sex – despite the fact that many older people tend to practice “solo sex,” another term for masturbation.
“Maybe they don’t have a partner, or their partner has sexual dysfunction, or has died. There could be pain involved,” Dr. Steckenrider said. “In the hierarchy of sexual activity, penetrative sex is the cultural norm. As people get older, penetrative sex becomes less important. The hierarchy shifts to include more emotional intimacy like touching and fondling.”
Of the 17 survey questionnaires Dr. Steckenrider analyzed, 11 had questions that focused exclusively on sex with a partner. Nine defined sexual activity and just five included questions about masturbation.
Take, for example, a 2018 poll by researchers at the University of Michigan, Ann Arbor, who found that 40% of people ages 65-80 said they were sexually active. Meanwhile, nearly two thirds of older adults said they were interested in sex, and more than half said sex was important to their quality of life.
But Dr. Steckenrider said this poll, like others, left the term “sexually active” undefined – raising questions about the meaning of the findings.
Sheryl A. Kingsberg, PhD, chief of behavioral medicine in the department of obstetrics and gynecology at University Hospitals Cleveland Medical Center, said she was surprised so few of the studies analyzed by Dr. Steckenrider included masturbation in their definition of sex.
“Clinical trials of potential treatments for female sexual problems, like hypoactive sexual desire disorder or painful sex, include both definitions of sexual activity and questions about masturbation, she said. “Definitions also should not assume partnered sex is male or female,” she added.
Dr. Steckenrider and Dr. Kingsberg encouraged healthcare providers to address the sexual health of their patients by asking questions about their sexual health and concerns.
“Health care professionals cannot address sexual concerns if they don’t acknowledge their patients as sexual beings and inquire about sexual problems,” Dr. Kingsberg said.
The key, according to Dr. Steckenrider, is for clinicians to ask the right questions. But which ones?
Detail is crucial.
“I think that’s far better than asking whether they are sexually active, yes or no,” she said. “Ask: ‘How often have you engaged in these types of sexual activities?’ If you are looking for frequency, and be specific about the types of sex: kissing, fondling, or masturbation.”
A version of this article first appeared on Medscape.com.
Sexual activity in older adults is something of a taboo, rarely discussed and largely ignored by researchers.
But failing to address human sexuality in old age can lead doctors to ask seniors the wrong questions about sex – if they ask at all.
When researchers do look at the issue, they find surprises, as Janie Steckenrider, PhD, has learned. In a new study presented at the annual scientific meeting of the Gerontological Society of America, Dr. Steckenrider, a professor of political science at Loyola Marymount University, Los Angeles, found that previous attempts to qualify the sexual activities of seniors appear to be limited largely to partnered sex – despite the fact that many older people tend to practice “solo sex,” another term for masturbation.
“Maybe they don’t have a partner, or their partner has sexual dysfunction, or has died. There could be pain involved,” Dr. Steckenrider said. “In the hierarchy of sexual activity, penetrative sex is the cultural norm. As people get older, penetrative sex becomes less important. The hierarchy shifts to include more emotional intimacy like touching and fondling.”
Of the 17 survey questionnaires Dr. Steckenrider analyzed, 11 had questions that focused exclusively on sex with a partner. Nine defined sexual activity and just five included questions about masturbation.
Take, for example, a 2018 poll by researchers at the University of Michigan, Ann Arbor, who found that 40% of people ages 65-80 said they were sexually active. Meanwhile, nearly two thirds of older adults said they were interested in sex, and more than half said sex was important to their quality of life.
But Dr. Steckenrider said this poll, like others, left the term “sexually active” undefined – raising questions about the meaning of the findings.
Sheryl A. Kingsberg, PhD, chief of behavioral medicine in the department of obstetrics and gynecology at University Hospitals Cleveland Medical Center, said she was surprised so few of the studies analyzed by Dr. Steckenrider included masturbation in their definition of sex.
“Clinical trials of potential treatments for female sexual problems, like hypoactive sexual desire disorder or painful sex, include both definitions of sexual activity and questions about masturbation, she said. “Definitions also should not assume partnered sex is male or female,” she added.
Dr. Steckenrider and Dr. Kingsberg encouraged healthcare providers to address the sexual health of their patients by asking questions about their sexual health and concerns.
“Health care professionals cannot address sexual concerns if they don’t acknowledge their patients as sexual beings and inquire about sexual problems,” Dr. Kingsberg said.
The key, according to Dr. Steckenrider, is for clinicians to ask the right questions. But which ones?
Detail is crucial.
“I think that’s far better than asking whether they are sexually active, yes or no,” she said. “Ask: ‘How often have you engaged in these types of sexual activities?’ If you are looking for frequency, and be specific about the types of sex: kissing, fondling, or masturbation.”
A version of this article first appeared on Medscape.com.
Sexual activity in older adults is something of a taboo, rarely discussed and largely ignored by researchers.
But failing to address human sexuality in old age can lead doctors to ask seniors the wrong questions about sex – if they ask at all.
When researchers do look at the issue, they find surprises, as Janie Steckenrider, PhD, has learned. In a new study presented at the annual scientific meeting of the Gerontological Society of America, Dr. Steckenrider, a professor of political science at Loyola Marymount University, Los Angeles, found that previous attempts to qualify the sexual activities of seniors appear to be limited largely to partnered sex – despite the fact that many older people tend to practice “solo sex,” another term for masturbation.
“Maybe they don’t have a partner, or their partner has sexual dysfunction, or has died. There could be pain involved,” Dr. Steckenrider said. “In the hierarchy of sexual activity, penetrative sex is the cultural norm. As people get older, penetrative sex becomes less important. The hierarchy shifts to include more emotional intimacy like touching and fondling.”
Of the 17 survey questionnaires Dr. Steckenrider analyzed, 11 had questions that focused exclusively on sex with a partner. Nine defined sexual activity and just five included questions about masturbation.
Take, for example, a 2018 poll by researchers at the University of Michigan, Ann Arbor, who found that 40% of people ages 65-80 said they were sexually active. Meanwhile, nearly two thirds of older adults said they were interested in sex, and more than half said sex was important to their quality of life.
But Dr. Steckenrider said this poll, like others, left the term “sexually active” undefined – raising questions about the meaning of the findings.
Sheryl A. Kingsberg, PhD, chief of behavioral medicine in the department of obstetrics and gynecology at University Hospitals Cleveland Medical Center, said she was surprised so few of the studies analyzed by Dr. Steckenrider included masturbation in their definition of sex.
“Clinical trials of potential treatments for female sexual problems, like hypoactive sexual desire disorder or painful sex, include both definitions of sexual activity and questions about masturbation, she said. “Definitions also should not assume partnered sex is male or female,” she added.
Dr. Steckenrider and Dr. Kingsberg encouraged healthcare providers to address the sexual health of their patients by asking questions about their sexual health and concerns.
“Health care professionals cannot address sexual concerns if they don’t acknowledge their patients as sexual beings and inquire about sexual problems,” Dr. Kingsberg said.
The key, according to Dr. Steckenrider, is for clinicians to ask the right questions. But which ones?
Detail is crucial.
“I think that’s far better than asking whether they are sexually active, yes or no,” she said. “Ask: ‘How often have you engaged in these types of sexual activities?’ If you are looking for frequency, and be specific about the types of sex: kissing, fondling, or masturbation.”
A version of this article first appeared on Medscape.com.
How can I keep from losing my mind?
A) Thiamine
B) Vitamin E
C) Multivitamin (MV)
D) Keto diet
E) Red wine
FDA-approved therapies for dementia
To date the actual therapies for dementia have been disappointing. Donepezil, the most prescribed medication for the treatment of dementia has a number-needed-to treat (NNT) over 17, and causes frequent side effects. Aducanumab was recently approved by the Food and Drug Administration for the treatment of Alzheimer’s disease (AD), but controversy has arisen, as the clinical results were modest, and the price tag will be large – estimated at $30,000-$50,000/year.
Preventive options that may decrease the likelihood of dementia
Patients often ask the question stated above. Regarding how to respond to that question, choice C, MV, has some recent evidence of benefit. Baker and colleagues studied the effect of cocoa extract and multivitamins on cognitive function in the COSMOS-Mind trial.1 A total of 2,262 people were enrolled, and over 90% completed baseline and at least one annual cognitive assessment. Cocoa extract had no impact on global cognition (confidence interval [CI], –.02-.08, P = .28), but MV supplementation did have a statistically significant impact on global cognition (CI, .02-.12, P less than .007).
Vitamin E has been enthusiastically endorsed in the past as a treatment to prevent cognitive decline. The most recent Cochrane review on vitamin E concluded there was no evidence that the alpha-tocopherol form of vitamin E given to people with MCI prevents progression to dementia, or that it improves cognitive function in people with MCI or dementia due to AD.2
Exercise has long been a mainstay of our advice to patients as something they can do to help prevent dementia. Yu and colleagues did a meta-analysis of almost 400 randomized controlled trials and observational studies to grade the evidence on different interventions.3 They gave exercise a grade B for evidence of benefit.
A recent study addressed this issue, and I think it is helpful on quantifying how much exercise is needed. Del Pozo Cruz and colleagues did a prospective population-based cohort study of 78,000 adults aged 40-79, with an average of 6.9 years of follow up.4 The optimal step count was 9,826 steps (hazard ratio [HR], 0.49; 95% CI, 0.39-0.62) and the minimal step count for benefit was 3,826 steps (HR, 0.75; 95% CI, 0.67-0.83).
Modifiable factors
The other major modifiable factors to consider are problems with special senses. Both vision loss and hearing loss have been associated with cognitive impairment.
Shang and colleagues published a meta-analysis of 14 cohort studies addressing vision impairment and cognitive function involving more than 6 million individuals.5 They concluded that vision impairment is associated with an increased risk of both dementia and cognitive impairment in older adults.
Loughrey and colleagues performed a meta-analysis of 36 studies addressing hearing loss and cognitive decline.6 They reported that, among cross-sectional studies, a significant association was found for cognitive impairment (odds ratio [OR], 2.00; 95% CI, 1.39-2.89) and dementia (OR, 2.42; 95% CI, 1.24-4.72). A similar finding was present in prospective cohort studies with a significant association being found for cognitive impairment (OR, 1.22; 95% CI, 1.09-1.36) and dementia (OR, 1.28; 95% CI, 1.02-1.59).
A 25-year prospective, population-based study of patients with hearing loss revealed a difference in the rate of change in MMSE score over the 25-year follow-up between participants with hearing loss not using hearing aids matched with controls who didn’t have hearing loss. Those with untreated hearing loss had more cognitive decline than that of patients without hearing loss.7 The subjects with hearing loss using a hearing aid had no difference in cognitive decline from controls.
Pearl
Several simple and safe interventions may protect our patients from cognitive decline. These include taking a daily multivitamin, walking more than 4,000 steps a day, and optimizing vision and hearing.
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. Contact Dr. Paauw at [email protected].
References
1. Baker LD et al. Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial. Alzheimer’s Dement. 2022 Sep 14. doi: 10.1002/alz.12767.
2. Farina N et al. Vitamin E for Alzheimer’s dementia and mild cognitive impairment. Cochrane Database Syst Rev. 2017 Apr 18;4(4):CD002854. doi: 10.1002/14651858.CD002854.pub5.
3. Yu JT et al. Evidence-based prevention of Alzheimer’s disease: Systematic review and meta-analysis of 243 observational prospective studies and 153 randomised controlled trials. J Neurol Neurosurg Psychiatry. 2020 Nov;91(11):1201-9.
4. Del Pozo Cruz B et al. Association of daily step count and intensity with incident dementia in 78,430 adults living in the UK. JAMA Neurol. 2022 Oct 1;79(10):1059-63.
5. Shang X et al. The association between vision impairment and incidence of dementia and cognitive impairment: A systematic review and meta-analysis. Ophthalmology. 2021 Aug;128(8):1135-49.
6. Loughrey DG et al. Association of age-related hearing loss with cognitive function, cognitive impairment, and dementia: A systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Feb 1;144(2):115-26.
7. Amieva H et al. Self-reported hearing loss, hearing aids, and cognitive decline in elderly adults: A 25-year study. J Am Geriatr Soc. 2015 Oct;63(10):2099-104.
A) Thiamine
B) Vitamin E
C) Multivitamin (MV)
D) Keto diet
E) Red wine
FDA-approved therapies for dementia
To date the actual therapies for dementia have been disappointing. Donepezil, the most prescribed medication for the treatment of dementia has a number-needed-to treat (NNT) over 17, and causes frequent side effects. Aducanumab was recently approved by the Food and Drug Administration for the treatment of Alzheimer’s disease (AD), but controversy has arisen, as the clinical results were modest, and the price tag will be large – estimated at $30,000-$50,000/year.
Preventive options that may decrease the likelihood of dementia
Patients often ask the question stated above. Regarding how to respond to that question, choice C, MV, has some recent evidence of benefit. Baker and colleagues studied the effect of cocoa extract and multivitamins on cognitive function in the COSMOS-Mind trial.1 A total of 2,262 people were enrolled, and over 90% completed baseline and at least one annual cognitive assessment. Cocoa extract had no impact on global cognition (confidence interval [CI], –.02-.08, P = .28), but MV supplementation did have a statistically significant impact on global cognition (CI, .02-.12, P less than .007).
Vitamin E has been enthusiastically endorsed in the past as a treatment to prevent cognitive decline. The most recent Cochrane review on vitamin E concluded there was no evidence that the alpha-tocopherol form of vitamin E given to people with MCI prevents progression to dementia, or that it improves cognitive function in people with MCI or dementia due to AD.2
Exercise has long been a mainstay of our advice to patients as something they can do to help prevent dementia. Yu and colleagues did a meta-analysis of almost 400 randomized controlled trials and observational studies to grade the evidence on different interventions.3 They gave exercise a grade B for evidence of benefit.
A recent study addressed this issue, and I think it is helpful on quantifying how much exercise is needed. Del Pozo Cruz and colleagues did a prospective population-based cohort study of 78,000 adults aged 40-79, with an average of 6.9 years of follow up.4 The optimal step count was 9,826 steps (hazard ratio [HR], 0.49; 95% CI, 0.39-0.62) and the minimal step count for benefit was 3,826 steps (HR, 0.75; 95% CI, 0.67-0.83).
Modifiable factors
The other major modifiable factors to consider are problems with special senses. Both vision loss and hearing loss have been associated with cognitive impairment.
Shang and colleagues published a meta-analysis of 14 cohort studies addressing vision impairment and cognitive function involving more than 6 million individuals.5 They concluded that vision impairment is associated with an increased risk of both dementia and cognitive impairment in older adults.
Loughrey and colleagues performed a meta-analysis of 36 studies addressing hearing loss and cognitive decline.6 They reported that, among cross-sectional studies, a significant association was found for cognitive impairment (odds ratio [OR], 2.00; 95% CI, 1.39-2.89) and dementia (OR, 2.42; 95% CI, 1.24-4.72). A similar finding was present in prospective cohort studies with a significant association being found for cognitive impairment (OR, 1.22; 95% CI, 1.09-1.36) and dementia (OR, 1.28; 95% CI, 1.02-1.59).
A 25-year prospective, population-based study of patients with hearing loss revealed a difference in the rate of change in MMSE score over the 25-year follow-up between participants with hearing loss not using hearing aids matched with controls who didn’t have hearing loss. Those with untreated hearing loss had more cognitive decline than that of patients without hearing loss.7 The subjects with hearing loss using a hearing aid had no difference in cognitive decline from controls.
Pearl
Several simple and safe interventions may protect our patients from cognitive decline. These include taking a daily multivitamin, walking more than 4,000 steps a day, and optimizing vision and hearing.
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. Contact Dr. Paauw at [email protected].
References
1. Baker LD et al. Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial. Alzheimer’s Dement. 2022 Sep 14. doi: 10.1002/alz.12767.
2. Farina N et al. Vitamin E for Alzheimer’s dementia and mild cognitive impairment. Cochrane Database Syst Rev. 2017 Apr 18;4(4):CD002854. doi: 10.1002/14651858.CD002854.pub5.
3. Yu JT et al. Evidence-based prevention of Alzheimer’s disease: Systematic review and meta-analysis of 243 observational prospective studies and 153 randomised controlled trials. J Neurol Neurosurg Psychiatry. 2020 Nov;91(11):1201-9.
4. Del Pozo Cruz B et al. Association of daily step count and intensity with incident dementia in 78,430 adults living in the UK. JAMA Neurol. 2022 Oct 1;79(10):1059-63.
5. Shang X et al. The association between vision impairment and incidence of dementia and cognitive impairment: A systematic review and meta-analysis. Ophthalmology. 2021 Aug;128(8):1135-49.
6. Loughrey DG et al. Association of age-related hearing loss with cognitive function, cognitive impairment, and dementia: A systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Feb 1;144(2):115-26.
7. Amieva H et al. Self-reported hearing loss, hearing aids, and cognitive decline in elderly adults: A 25-year study. J Am Geriatr Soc. 2015 Oct;63(10):2099-104.
A) Thiamine
B) Vitamin E
C) Multivitamin (MV)
D) Keto diet
E) Red wine
FDA-approved therapies for dementia
To date the actual therapies for dementia have been disappointing. Donepezil, the most prescribed medication for the treatment of dementia has a number-needed-to treat (NNT) over 17, and causes frequent side effects. Aducanumab was recently approved by the Food and Drug Administration for the treatment of Alzheimer’s disease (AD), but controversy has arisen, as the clinical results were modest, and the price tag will be large – estimated at $30,000-$50,000/year.
Preventive options that may decrease the likelihood of dementia
Patients often ask the question stated above. Regarding how to respond to that question, choice C, MV, has some recent evidence of benefit. Baker and colleagues studied the effect of cocoa extract and multivitamins on cognitive function in the COSMOS-Mind trial.1 A total of 2,262 people were enrolled, and over 90% completed baseline and at least one annual cognitive assessment. Cocoa extract had no impact on global cognition (confidence interval [CI], –.02-.08, P = .28), but MV supplementation did have a statistically significant impact on global cognition (CI, .02-.12, P less than .007).
Vitamin E has been enthusiastically endorsed in the past as a treatment to prevent cognitive decline. The most recent Cochrane review on vitamin E concluded there was no evidence that the alpha-tocopherol form of vitamin E given to people with MCI prevents progression to dementia, or that it improves cognitive function in people with MCI or dementia due to AD.2
Exercise has long been a mainstay of our advice to patients as something they can do to help prevent dementia. Yu and colleagues did a meta-analysis of almost 400 randomized controlled trials and observational studies to grade the evidence on different interventions.3 They gave exercise a grade B for evidence of benefit.
A recent study addressed this issue, and I think it is helpful on quantifying how much exercise is needed. Del Pozo Cruz and colleagues did a prospective population-based cohort study of 78,000 adults aged 40-79, with an average of 6.9 years of follow up.4 The optimal step count was 9,826 steps (hazard ratio [HR], 0.49; 95% CI, 0.39-0.62) and the minimal step count for benefit was 3,826 steps (HR, 0.75; 95% CI, 0.67-0.83).
Modifiable factors
The other major modifiable factors to consider are problems with special senses. Both vision loss and hearing loss have been associated with cognitive impairment.
Shang and colleagues published a meta-analysis of 14 cohort studies addressing vision impairment and cognitive function involving more than 6 million individuals.5 They concluded that vision impairment is associated with an increased risk of both dementia and cognitive impairment in older adults.
Loughrey and colleagues performed a meta-analysis of 36 studies addressing hearing loss and cognitive decline.6 They reported that, among cross-sectional studies, a significant association was found for cognitive impairment (odds ratio [OR], 2.00; 95% CI, 1.39-2.89) and dementia (OR, 2.42; 95% CI, 1.24-4.72). A similar finding was present in prospective cohort studies with a significant association being found for cognitive impairment (OR, 1.22; 95% CI, 1.09-1.36) and dementia (OR, 1.28; 95% CI, 1.02-1.59).
A 25-year prospective, population-based study of patients with hearing loss revealed a difference in the rate of change in MMSE score over the 25-year follow-up between participants with hearing loss not using hearing aids matched with controls who didn’t have hearing loss. Those with untreated hearing loss had more cognitive decline than that of patients without hearing loss.7 The subjects with hearing loss using a hearing aid had no difference in cognitive decline from controls.
Pearl
Several simple and safe interventions may protect our patients from cognitive decline. These include taking a daily multivitamin, walking more than 4,000 steps a day, and optimizing vision and hearing.
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. Contact Dr. Paauw at [email protected].
References
1. Baker LD et al. Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial. Alzheimer’s Dement. 2022 Sep 14. doi: 10.1002/alz.12767.
2. Farina N et al. Vitamin E for Alzheimer’s dementia and mild cognitive impairment. Cochrane Database Syst Rev. 2017 Apr 18;4(4):CD002854. doi: 10.1002/14651858.CD002854.pub5.
3. Yu JT et al. Evidence-based prevention of Alzheimer’s disease: Systematic review and meta-analysis of 243 observational prospective studies and 153 randomised controlled trials. J Neurol Neurosurg Psychiatry. 2020 Nov;91(11):1201-9.
4. Del Pozo Cruz B et al. Association of daily step count and intensity with incident dementia in 78,430 adults living in the UK. JAMA Neurol. 2022 Oct 1;79(10):1059-63.
5. Shang X et al. The association between vision impairment and incidence of dementia and cognitive impairment: A systematic review and meta-analysis. Ophthalmology. 2021 Aug;128(8):1135-49.
6. Loughrey DG et al. Association of age-related hearing loss with cognitive function, cognitive impairment, and dementia: A systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Feb 1;144(2):115-26.
7. Amieva H et al. Self-reported hearing loss, hearing aids, and cognitive decline in elderly adults: A 25-year study. J Am Geriatr Soc. 2015 Oct;63(10):2099-104.
Vedolizumab linked to increased treatment failure in older patients with Crohn’s
Findings indicate that vedolizumab is associated with an increased risk for treatment failure in older patients with inflammatory bowel disease (IBD), as compared with tumor necrosis factor (TNF) antagonists, according to a new study published in JAMA Network Open.
Although the incidence and prevalence of IBD among older adults are rapidly increasing, there is a lack of evidence-based treatment guidance for these patients, who represent less than 5% of participants in IBD-related clinical trials, wrote Siddharth Singh, MD, a gastroenterologist and assistant professor of medicine at the University of California, San Diego, and colleagues.
“Older patients are frequently undertreated and mismanaged with long-term corticosteroid use and limited use of steroid-sparing therapies owing to patients’ and clinicians’ concerns about the safety of immunosuppressive therapy,” the authors wrote. “There is considerable need for evidence-based treatment guidance for older patients with IBD.”
The researchers undertook an observational study of the comparative effectiveness of vedolizumab versus TNF antagonists (namely infliximab, adalimumab, and golimumab) among older patients with IBD in Denmark. Using the Danish National Patient Register, the authors included 754 patients aged 50 years and older who received treatment between 2005 and 2018.
The primary effectiveness outcome was treatment failure, defined as the composite 1-year risk of IBD-related hospitalization, IBD-related surgery, or a new corticosteroid prescription more than 6 weeks after initiation of treatment with a biologic. Secondary effectiveness outcomes included time to each component included in the composite score.
The primary safety outcome was the risk of serious infections, defined as those that required hospitalization. Secondary safety outcomes were risk of cancer and major adverse cardiovascular or venous thromboembolic events.
The researchers conducted a 1:1 propensity score-matched analysis, accounting for patient, disease, and treatment factors. The 754 patients included 377 incident users of vedolizumab, including 177 with Crohn’s disease; and 377 incident users of TNF antagonists, including 182 with Crohn’s disease. The average follow-up after treatment initiation occurred between 32 and 40 weeks.
Notably, patients treated with vedolizumab were more likely than those treated with TNF antagonists to have multimorbidity, at 16.2% versus 14.1%, and a higher burden of frailty, at 2.7% versus 1.9%. No significant differences were observed in the proportion of patients with recent immunomodulator and corticosteroid exposure.
Overall, vedolizumab was associated with a 31% increased risk of treatment failure (45.4%), compared with TNF antagonists (34.7%). This included an increased risk of IBD-related hospitalization (27.8% versus 16.3%) and IBD-related major abdominal surgery (21.3% versus 8%).
Among patients with Crohn’s disease, vedolizumab was associated with a 77% increased risk of treatment failure, as well as a greater need for corticosteroids. There was no significant difference in the risk of treatment failure or need for corticosteroids in patients with ulcerative colitis
No significant differences were seen in the risk of serious infections between patients treated with vedolizumab or TNF antagonists, at 8.2% versus 8.7%. This didn’t change by IBD phenotype, age at time of biologic therapy initiation, or treatment with biologic monotherapy versus combination therapy with immunomodulators.
The overall incidence of major adverse cardiovascular or venous thromboembolic events was similar among the groups. Rates of new malignant neoplasms were low, with fewer than five events.
In a subgroup analysis based on the Charlson Comorbidity Index, vedolizumab was associated with a 63% increased risk of treatment failure for patients without comorbidities but not for patients with comorbidities.
“This study adds to the body of literature comparing vedolizumab and anti-TNF in older adults. The findings have been mixed, in some part due to differences in study designs,” said Ashwin N. Ananthakrishnan, MBBS, MPH, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, both in Boston.
Dr. Ananthakrishnan, who wasn’t involved with this study, has previously researched the two treatments and found that they are comparably safe in older adults. In fact, among patients with significant comorbidity, vedolizumab may be safer. However, the Danish study wasn’t powered to describe that, he said. Moreover, patient characteristics and treatment approaches likely differ between the United States and Denmark.
“Overall, the findings are reassuring. Often when we treat older adults, the emphasis is on safety,” he said. “But by highlighting the difference in clinical response rates – their findings being consistent with a study we published a few years ago – it highlights the importance of also considering efficacy and onset of action for specific disease phenotypes in treatment selection.”
Dr. Ananthakrishnan and colleagues are currently developing clinical tools for risk stratification and prognostication in older adults with IBD, including functional and frailty assessments. “Biologically, older adults may be particularly vulnerable to specific treatment risks such as infections and cancer, but they are also vulnerable to the consequences of untreated disease, including loss of functional independence and frailty,” he explained. “Thus, arriving at the right risk to benefit balance is critically important when making treatment decisions for older adults.”
The study by Dr. Singh and colleagues was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and the Danish National Research Foundation. Dr. Singh reported receiving grants from pharmaceutical companies unrelated to the study, as well as support from the International Organization for the Study of Inflammatory Bowel Disease Operating Grant and Litwin Pioneers in IBD. No other disclosures were reported. Dr. Ananthakrishnan reported no relevant disclosures.
Findings indicate that vedolizumab is associated with an increased risk for treatment failure in older patients with inflammatory bowel disease (IBD), as compared with tumor necrosis factor (TNF) antagonists, according to a new study published in JAMA Network Open.
Although the incidence and prevalence of IBD among older adults are rapidly increasing, there is a lack of evidence-based treatment guidance for these patients, who represent less than 5% of participants in IBD-related clinical trials, wrote Siddharth Singh, MD, a gastroenterologist and assistant professor of medicine at the University of California, San Diego, and colleagues.
“Older patients are frequently undertreated and mismanaged with long-term corticosteroid use and limited use of steroid-sparing therapies owing to patients’ and clinicians’ concerns about the safety of immunosuppressive therapy,” the authors wrote. “There is considerable need for evidence-based treatment guidance for older patients with IBD.”
The researchers undertook an observational study of the comparative effectiveness of vedolizumab versus TNF antagonists (namely infliximab, adalimumab, and golimumab) among older patients with IBD in Denmark. Using the Danish National Patient Register, the authors included 754 patients aged 50 years and older who received treatment between 2005 and 2018.
The primary effectiveness outcome was treatment failure, defined as the composite 1-year risk of IBD-related hospitalization, IBD-related surgery, or a new corticosteroid prescription more than 6 weeks after initiation of treatment with a biologic. Secondary effectiveness outcomes included time to each component included in the composite score.
The primary safety outcome was the risk of serious infections, defined as those that required hospitalization. Secondary safety outcomes were risk of cancer and major adverse cardiovascular or venous thromboembolic events.
The researchers conducted a 1:1 propensity score-matched analysis, accounting for patient, disease, and treatment factors. The 754 patients included 377 incident users of vedolizumab, including 177 with Crohn’s disease; and 377 incident users of TNF antagonists, including 182 with Crohn’s disease. The average follow-up after treatment initiation occurred between 32 and 40 weeks.
Notably, patients treated with vedolizumab were more likely than those treated with TNF antagonists to have multimorbidity, at 16.2% versus 14.1%, and a higher burden of frailty, at 2.7% versus 1.9%. No significant differences were observed in the proportion of patients with recent immunomodulator and corticosteroid exposure.
Overall, vedolizumab was associated with a 31% increased risk of treatment failure (45.4%), compared with TNF antagonists (34.7%). This included an increased risk of IBD-related hospitalization (27.8% versus 16.3%) and IBD-related major abdominal surgery (21.3% versus 8%).
Among patients with Crohn’s disease, vedolizumab was associated with a 77% increased risk of treatment failure, as well as a greater need for corticosteroids. There was no significant difference in the risk of treatment failure or need for corticosteroids in patients with ulcerative colitis
No significant differences were seen in the risk of serious infections between patients treated with vedolizumab or TNF antagonists, at 8.2% versus 8.7%. This didn’t change by IBD phenotype, age at time of biologic therapy initiation, or treatment with biologic monotherapy versus combination therapy with immunomodulators.
The overall incidence of major adverse cardiovascular or venous thromboembolic events was similar among the groups. Rates of new malignant neoplasms were low, with fewer than five events.
In a subgroup analysis based on the Charlson Comorbidity Index, vedolizumab was associated with a 63% increased risk of treatment failure for patients without comorbidities but not for patients with comorbidities.
“This study adds to the body of literature comparing vedolizumab and anti-TNF in older adults. The findings have been mixed, in some part due to differences in study designs,” said Ashwin N. Ananthakrishnan, MBBS, MPH, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, both in Boston.
Dr. Ananthakrishnan, who wasn’t involved with this study, has previously researched the two treatments and found that they are comparably safe in older adults. In fact, among patients with significant comorbidity, vedolizumab may be safer. However, the Danish study wasn’t powered to describe that, he said. Moreover, patient characteristics and treatment approaches likely differ between the United States and Denmark.
“Overall, the findings are reassuring. Often when we treat older adults, the emphasis is on safety,” he said. “But by highlighting the difference in clinical response rates – their findings being consistent with a study we published a few years ago – it highlights the importance of also considering efficacy and onset of action for specific disease phenotypes in treatment selection.”
Dr. Ananthakrishnan and colleagues are currently developing clinical tools for risk stratification and prognostication in older adults with IBD, including functional and frailty assessments. “Biologically, older adults may be particularly vulnerable to specific treatment risks such as infections and cancer, but they are also vulnerable to the consequences of untreated disease, including loss of functional independence and frailty,” he explained. “Thus, arriving at the right risk to benefit balance is critically important when making treatment decisions for older adults.”
The study by Dr. Singh and colleagues was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and the Danish National Research Foundation. Dr. Singh reported receiving grants from pharmaceutical companies unrelated to the study, as well as support from the International Organization for the Study of Inflammatory Bowel Disease Operating Grant and Litwin Pioneers in IBD. No other disclosures were reported. Dr. Ananthakrishnan reported no relevant disclosures.
Findings indicate that vedolizumab is associated with an increased risk for treatment failure in older patients with inflammatory bowel disease (IBD), as compared with tumor necrosis factor (TNF) antagonists, according to a new study published in JAMA Network Open.
Although the incidence and prevalence of IBD among older adults are rapidly increasing, there is a lack of evidence-based treatment guidance for these patients, who represent less than 5% of participants in IBD-related clinical trials, wrote Siddharth Singh, MD, a gastroenterologist and assistant professor of medicine at the University of California, San Diego, and colleagues.
“Older patients are frequently undertreated and mismanaged with long-term corticosteroid use and limited use of steroid-sparing therapies owing to patients’ and clinicians’ concerns about the safety of immunosuppressive therapy,” the authors wrote. “There is considerable need for evidence-based treatment guidance for older patients with IBD.”
The researchers undertook an observational study of the comparative effectiveness of vedolizumab versus TNF antagonists (namely infliximab, adalimumab, and golimumab) among older patients with IBD in Denmark. Using the Danish National Patient Register, the authors included 754 patients aged 50 years and older who received treatment between 2005 and 2018.
The primary effectiveness outcome was treatment failure, defined as the composite 1-year risk of IBD-related hospitalization, IBD-related surgery, or a new corticosteroid prescription more than 6 weeks after initiation of treatment with a biologic. Secondary effectiveness outcomes included time to each component included in the composite score.
The primary safety outcome was the risk of serious infections, defined as those that required hospitalization. Secondary safety outcomes were risk of cancer and major adverse cardiovascular or venous thromboembolic events.
The researchers conducted a 1:1 propensity score-matched analysis, accounting for patient, disease, and treatment factors. The 754 patients included 377 incident users of vedolizumab, including 177 with Crohn’s disease; and 377 incident users of TNF antagonists, including 182 with Crohn’s disease. The average follow-up after treatment initiation occurred between 32 and 40 weeks.
Notably, patients treated with vedolizumab were more likely than those treated with TNF antagonists to have multimorbidity, at 16.2% versus 14.1%, and a higher burden of frailty, at 2.7% versus 1.9%. No significant differences were observed in the proportion of patients with recent immunomodulator and corticosteroid exposure.
Overall, vedolizumab was associated with a 31% increased risk of treatment failure (45.4%), compared with TNF antagonists (34.7%). This included an increased risk of IBD-related hospitalization (27.8% versus 16.3%) and IBD-related major abdominal surgery (21.3% versus 8%).
Among patients with Crohn’s disease, vedolizumab was associated with a 77% increased risk of treatment failure, as well as a greater need for corticosteroids. There was no significant difference in the risk of treatment failure or need for corticosteroids in patients with ulcerative colitis
No significant differences were seen in the risk of serious infections between patients treated with vedolizumab or TNF antagonists, at 8.2% versus 8.7%. This didn’t change by IBD phenotype, age at time of biologic therapy initiation, or treatment with biologic monotherapy versus combination therapy with immunomodulators.
The overall incidence of major adverse cardiovascular or venous thromboembolic events was similar among the groups. Rates of new malignant neoplasms were low, with fewer than five events.
In a subgroup analysis based on the Charlson Comorbidity Index, vedolizumab was associated with a 63% increased risk of treatment failure for patients without comorbidities but not for patients with comorbidities.
“This study adds to the body of literature comparing vedolizumab and anti-TNF in older adults. The findings have been mixed, in some part due to differences in study designs,” said Ashwin N. Ananthakrishnan, MBBS, MPH, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, both in Boston.
Dr. Ananthakrishnan, who wasn’t involved with this study, has previously researched the two treatments and found that they are comparably safe in older adults. In fact, among patients with significant comorbidity, vedolizumab may be safer. However, the Danish study wasn’t powered to describe that, he said. Moreover, patient characteristics and treatment approaches likely differ between the United States and Denmark.
“Overall, the findings are reassuring. Often when we treat older adults, the emphasis is on safety,” he said. “But by highlighting the difference in clinical response rates – their findings being consistent with a study we published a few years ago – it highlights the importance of also considering efficacy and onset of action for specific disease phenotypes in treatment selection.”
Dr. Ananthakrishnan and colleagues are currently developing clinical tools for risk stratification and prognostication in older adults with IBD, including functional and frailty assessments. “Biologically, older adults may be particularly vulnerable to specific treatment risks such as infections and cancer, but they are also vulnerable to the consequences of untreated disease, including loss of functional independence and frailty,” he explained. “Thus, arriving at the right risk to benefit balance is critically important when making treatment decisions for older adults.”
The study by Dr. Singh and colleagues was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and the Danish National Research Foundation. Dr. Singh reported receiving grants from pharmaceutical companies unrelated to the study, as well as support from the International Organization for the Study of Inflammatory Bowel Disease Operating Grant and Litwin Pioneers in IBD. No other disclosures were reported. Dr. Ananthakrishnan reported no relevant disclosures.
FROM JAMA NETWORK OPEN
Suicide notes offer ‘unique window’ into motives, risks in the elderly
A new analysis of notes penned by seniors who died by suicide reveals several common themes. These include feeling as if they were a burden, feelings of guilt, experiencing mental illness, loneliness, or isolation, as well as poor health and/or disability.
“The most important message [in our findings] is that there is hope,” study investigator Ari B. Cuperfain, MD, Temerty Faculty of Medicine, University of Toronto, told this news organization.
“Suicide risk is modifiable, and we encourage that care providers sensitively explore thoughts of suicide in patients expressing depressive thoughts or difficulty coping with other life stressors,” he said.
The study was published online in The American Journal of Geriatric Psychiatry.
Opportunity for intervention
Most previous studies of late-life suicide have focused on risk factors rather than the themes and meaning underlying individuals’ distress.
Dr. Cuperfain’s group had previously analyzed suicide notes to “explore the relationship between suicide and an individual’s experience with mental health care in all age groups,” he said. For the current study, the investigators analyzed the subset of notes written exclusively by older adults.
The researchers “hypothesized that suicide notes could provide a unique window into the thought processes of older adults during a critical window for mental health intervention,” he added.
Although effective screening for suicidality in older adults can mitigate suicide risk, the frequency of suicide screening decreases with increasing age, the authors noted.
In addition, suicide attempts are typically more often fatal in older adults than in the general population. Understanding the motivations for suicide in this vulnerable population can inform potential interventions.
The researchers used a constructivist grounded theory framework to analyze suicide notes available from their previous study and notes obtained from the Office of the Coroner in Toronto from adults aged 65 years and older (n = 29; mean [SD], age 76.2 [8.3] years; 79% men).
The investigators began with open coding of the notes, “specifying a short name to a segment of data that summarizes and accounts for each piece of data.” They then used a series of techniques to identify terms and themes (repeated patterns of ideas reflected in the data).
Once themes had been determined, they identified “pathways between these themes and the final act of suicide.”
Common themes
Four major themes emerged in the analysis of the suicide notes.
Recurring terms included “pain,” “[poor] sleep,” or “[wakeful] nights,” as well as “sorry” (either about past actions or about the suicide), and “I just can’t” (referring to the inability to carry on).
The suicide notes “provided the older writers’ conceptual schema for suicide, elucidating the cognitive process linking their narratives to the acts of suicide.” Examples included the following:
- Suicide as a way out or solution to an insoluble problem.
- Suicide as the final act in a long road of suffering.
- Suicide as the logical culmination of life (the person “lived a good life”).
“Our study enriches the understanding of ‘why’ rather than just ‘which’ older adults die by suicide,” the authors noted.
“Care providers can help older adults at risk of suicide through a combination of treatment options. These include physician involvement to manage depression, psychosis, or pain, psychotherapy to reframe certain ways of thinking, or social activities to reduce isolation,” Dr. Cuperfain said.
“By understanding the experiences of older adults and what is underlying their suicidal thoughts, these interventions can be tailored specifically for the individual experiencing distress,” he added.
Untangling suicide drivers
Commenting on the study, Yeates Conwell, MD, professor and vice chair, department of psychiatry, University of Rochester (N.Y.) Medical Center, said that “by analyzing the suicide notes of older people who died by suicide, the paper lends a unique perspective to our understanding of why they may have taken their lives.”
Dr. Conwell, director of the geriatric psychiatry program and codirector of the Center for the Study and Prevention of Suicide, University of Rochester, and author of an accompanying editorial, said that “by including the decedent’s own voice, the analysis of notes is a useful complement to other approaches used for the study of suicide in this age group”.
However, “like all other approaches, it is subject to potential biases in interpretation. The meaning in the notes must be derived with careful consideration of context, both what is said and what is not said, and the likelihood that both overt and covert messages are contained in and between their lines,” cautioned Dr. Conwell.
“Acknowledging the strength and limitations of each approach to the study of suicide death, together they can help untangle its drivers and support the search for effective, acceptable, and scalable prevention interventions. No one approach alone, however, will reveal the ‘cause’ of suicide,” Dr. Conwell wrote.
No source of study funding was provided. Dr. Cuperfain reports no relevant financial relationships. The other authors’ disclosures are listed on the original article. Dr. Conwell reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new analysis of notes penned by seniors who died by suicide reveals several common themes. These include feeling as if they were a burden, feelings of guilt, experiencing mental illness, loneliness, or isolation, as well as poor health and/or disability.
“The most important message [in our findings] is that there is hope,” study investigator Ari B. Cuperfain, MD, Temerty Faculty of Medicine, University of Toronto, told this news organization.
“Suicide risk is modifiable, and we encourage that care providers sensitively explore thoughts of suicide in patients expressing depressive thoughts or difficulty coping with other life stressors,” he said.
The study was published online in The American Journal of Geriatric Psychiatry.
Opportunity for intervention
Most previous studies of late-life suicide have focused on risk factors rather than the themes and meaning underlying individuals’ distress.
Dr. Cuperfain’s group had previously analyzed suicide notes to “explore the relationship between suicide and an individual’s experience with mental health care in all age groups,” he said. For the current study, the investigators analyzed the subset of notes written exclusively by older adults.
The researchers “hypothesized that suicide notes could provide a unique window into the thought processes of older adults during a critical window for mental health intervention,” he added.
Although effective screening for suicidality in older adults can mitigate suicide risk, the frequency of suicide screening decreases with increasing age, the authors noted.
In addition, suicide attempts are typically more often fatal in older adults than in the general population. Understanding the motivations for suicide in this vulnerable population can inform potential interventions.
The researchers used a constructivist grounded theory framework to analyze suicide notes available from their previous study and notes obtained from the Office of the Coroner in Toronto from adults aged 65 years and older (n = 29; mean [SD], age 76.2 [8.3] years; 79% men).
The investigators began with open coding of the notes, “specifying a short name to a segment of data that summarizes and accounts for each piece of data.” They then used a series of techniques to identify terms and themes (repeated patterns of ideas reflected in the data).
Once themes had been determined, they identified “pathways between these themes and the final act of suicide.”
Common themes
Four major themes emerged in the analysis of the suicide notes.
Recurring terms included “pain,” “[poor] sleep,” or “[wakeful] nights,” as well as “sorry” (either about past actions or about the suicide), and “I just can’t” (referring to the inability to carry on).
The suicide notes “provided the older writers’ conceptual schema for suicide, elucidating the cognitive process linking their narratives to the acts of suicide.” Examples included the following:
- Suicide as a way out or solution to an insoluble problem.
- Suicide as the final act in a long road of suffering.
- Suicide as the logical culmination of life (the person “lived a good life”).
“Our study enriches the understanding of ‘why’ rather than just ‘which’ older adults die by suicide,” the authors noted.
“Care providers can help older adults at risk of suicide through a combination of treatment options. These include physician involvement to manage depression, psychosis, or pain, psychotherapy to reframe certain ways of thinking, or social activities to reduce isolation,” Dr. Cuperfain said.
“By understanding the experiences of older adults and what is underlying their suicidal thoughts, these interventions can be tailored specifically for the individual experiencing distress,” he added.
Untangling suicide drivers
Commenting on the study, Yeates Conwell, MD, professor and vice chair, department of psychiatry, University of Rochester (N.Y.) Medical Center, said that “by analyzing the suicide notes of older people who died by suicide, the paper lends a unique perspective to our understanding of why they may have taken their lives.”
Dr. Conwell, director of the geriatric psychiatry program and codirector of the Center for the Study and Prevention of Suicide, University of Rochester, and author of an accompanying editorial, said that “by including the decedent’s own voice, the analysis of notes is a useful complement to other approaches used for the study of suicide in this age group”.
However, “like all other approaches, it is subject to potential biases in interpretation. The meaning in the notes must be derived with careful consideration of context, both what is said and what is not said, and the likelihood that both overt and covert messages are contained in and between their lines,” cautioned Dr. Conwell.
“Acknowledging the strength and limitations of each approach to the study of suicide death, together they can help untangle its drivers and support the search for effective, acceptable, and scalable prevention interventions. No one approach alone, however, will reveal the ‘cause’ of suicide,” Dr. Conwell wrote.
No source of study funding was provided. Dr. Cuperfain reports no relevant financial relationships. The other authors’ disclosures are listed on the original article. Dr. Conwell reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new analysis of notes penned by seniors who died by suicide reveals several common themes. These include feeling as if they were a burden, feelings of guilt, experiencing mental illness, loneliness, or isolation, as well as poor health and/or disability.
“The most important message [in our findings] is that there is hope,” study investigator Ari B. Cuperfain, MD, Temerty Faculty of Medicine, University of Toronto, told this news organization.
“Suicide risk is modifiable, and we encourage that care providers sensitively explore thoughts of suicide in patients expressing depressive thoughts or difficulty coping with other life stressors,” he said.
The study was published online in The American Journal of Geriatric Psychiatry.
Opportunity for intervention
Most previous studies of late-life suicide have focused on risk factors rather than the themes and meaning underlying individuals’ distress.
Dr. Cuperfain’s group had previously analyzed suicide notes to “explore the relationship between suicide and an individual’s experience with mental health care in all age groups,” he said. For the current study, the investigators analyzed the subset of notes written exclusively by older adults.
The researchers “hypothesized that suicide notes could provide a unique window into the thought processes of older adults during a critical window for mental health intervention,” he added.
Although effective screening for suicidality in older adults can mitigate suicide risk, the frequency of suicide screening decreases with increasing age, the authors noted.
In addition, suicide attempts are typically more often fatal in older adults than in the general population. Understanding the motivations for suicide in this vulnerable population can inform potential interventions.
The researchers used a constructivist grounded theory framework to analyze suicide notes available from their previous study and notes obtained from the Office of the Coroner in Toronto from adults aged 65 years and older (n = 29; mean [SD], age 76.2 [8.3] years; 79% men).
The investigators began with open coding of the notes, “specifying a short name to a segment of data that summarizes and accounts for each piece of data.” They then used a series of techniques to identify terms and themes (repeated patterns of ideas reflected in the data).
Once themes had been determined, they identified “pathways between these themes and the final act of suicide.”
Common themes
Four major themes emerged in the analysis of the suicide notes.
Recurring terms included “pain,” “[poor] sleep,” or “[wakeful] nights,” as well as “sorry” (either about past actions or about the suicide), and “I just can’t” (referring to the inability to carry on).
The suicide notes “provided the older writers’ conceptual schema for suicide, elucidating the cognitive process linking their narratives to the acts of suicide.” Examples included the following:
- Suicide as a way out or solution to an insoluble problem.
- Suicide as the final act in a long road of suffering.
- Suicide as the logical culmination of life (the person “lived a good life”).
“Our study enriches the understanding of ‘why’ rather than just ‘which’ older adults die by suicide,” the authors noted.
“Care providers can help older adults at risk of suicide through a combination of treatment options. These include physician involvement to manage depression, psychosis, or pain, psychotherapy to reframe certain ways of thinking, or social activities to reduce isolation,” Dr. Cuperfain said.
“By understanding the experiences of older adults and what is underlying their suicidal thoughts, these interventions can be tailored specifically for the individual experiencing distress,” he added.
Untangling suicide drivers
Commenting on the study, Yeates Conwell, MD, professor and vice chair, department of psychiatry, University of Rochester (N.Y.) Medical Center, said that “by analyzing the suicide notes of older people who died by suicide, the paper lends a unique perspective to our understanding of why they may have taken their lives.”
Dr. Conwell, director of the geriatric psychiatry program and codirector of the Center for the Study and Prevention of Suicide, University of Rochester, and author of an accompanying editorial, said that “by including the decedent’s own voice, the analysis of notes is a useful complement to other approaches used for the study of suicide in this age group”.
However, “like all other approaches, it is subject to potential biases in interpretation. The meaning in the notes must be derived with careful consideration of context, both what is said and what is not said, and the likelihood that both overt and covert messages are contained in and between their lines,” cautioned Dr. Conwell.
“Acknowledging the strength and limitations of each approach to the study of suicide death, together they can help untangle its drivers and support the search for effective, acceptable, and scalable prevention interventions. No one approach alone, however, will reveal the ‘cause’ of suicide,” Dr. Conwell wrote.
No source of study funding was provided. Dr. Cuperfain reports no relevant financial relationships. The other authors’ disclosures are listed on the original article. Dr. Conwell reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
Too old to practice medicine?
Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.
The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.
In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.
At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.
No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.
In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.
“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.
In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.
Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.
Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.
Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.
The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”
Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.
In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.
The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.
Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.
In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.
The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”
Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.
During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”
In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.
It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.
Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.
“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.
The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.
In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.
“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.
In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.
Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.
In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.
The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.
Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.
Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.
The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.
A version of this article first appeared on Medscape.com.
Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.
The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.
In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.
At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.
No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.
In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.
“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.
In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.
Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.
Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.
Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.
The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”
Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.
In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.
The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.
Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.
In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.
The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”
Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.
During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”
In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.
It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.
Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.
“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.
The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.
In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.
“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.
In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.
Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.
In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.
The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.
Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.
Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.
The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.
A version of this article first appeared on Medscape.com.
Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.
The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.
In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.
At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.
No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.
In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.
“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.
In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.
Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.
Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.
Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.
The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”
Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.
In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.
The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.
Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.
In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.
The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”
Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.
During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”
In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.
It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.
Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.
“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.
The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.
In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.
“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.
In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.
Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.
In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.
The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.
Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.
Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.
The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.
A version of this article first appeared on Medscape.com.