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MDedge conference coverage features onsite reporting of the latest study results and expert perspectives from leading researchers.
Weight cycling linked to cartilage degeneration in knee OA
Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.
A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m2 or above, which examined the effects of “weight cycling” on OA outcomes.
Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.
The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.
Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.
However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.
Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.
“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.
Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.
While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.
“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”
She suggested both these possibilities could be explored in future studies of weight cycling and its effects.
“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.
The study was supported by the National Institutes of Health. No conflicts of interest were declared.
Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.
A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m2 or above, which examined the effects of “weight cycling” on OA outcomes.
Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.
The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.
Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.
However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.
Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.
“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.
Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.
While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.
“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”
She suggested both these possibilities could be explored in future studies of weight cycling and its effects.
“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.
The study was supported by the National Institutes of Health. No conflicts of interest were declared.
Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.
A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m2 or above, which examined the effects of “weight cycling” on OA outcomes.
Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.
The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.
Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.
However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.
Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.
“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.
Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.
While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.
“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”
She suggested both these possibilities could be explored in future studies of weight cycling and its effects.
“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.
The study was supported by the National Institutes of Health. No conflicts of interest were declared.
FROM OARSI 2021
High MRD rates with CAR T in r/r B-ALL in kids
It’s early days, but preliminary data show that a chimeric antigen receptor T-cell therapy (CAR T) product was associated with high rates of minimal residual disease (MRD) negativity, and complete or near-complete responses in children and adolescents with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL).
Among 24 patients aged 3-20 years with relapsed or refractory B-ALL treated with the CAR T construct brexucabtagene autoleucel (KTE-X19; Tecartus), 16 had either a complete response or CR with incomplete recovery of blood counts (CRi), for a combined CR/CRi rate of 67%, reported Alan S. Wayne, MD, from Children’s Hospital Los Angeles and the University of Southern California Norris Comprehensive Cancer Center, also in Los Angeles.
“Optimized KTE-X19 formulation of 40 mL and revised toxicity management were associated with an improved risk/benefit profile,” he said in audio narration accompanying a poster presented during the annual meeting of the American Society of Pediatric Hematology/Oncology.
Although overall survival for children and adolescents receiving first-line therapy for B-ALL is associated with remission rates of 80% or more, the prognosis is poor following relapse, despite the availability of newer therapies such as blinatumomab (Blincyto) and inotuzumab (Besponsa), with a 1-year overall survival rate of approximately 36%, he said.
To see whether they could improve on these odds, Dr. Wayne and colleagues conducted the phase 1 Zuma-4 trial, a single-arm, open-label study in children and adolescents with relapsed/refractory B-ALL.
He reported long-term follow-up results from the study.
Zuma-4 details
A total of 24 patients, median age 14 (range 3 to 20) years, received the CAR T product. Four patients received the starting dose of 2 x 106 CAR T per kg (these patients were enrolled per protocol for evaluation of dose-limiting toxicities).
Following the initial dosing and evaluation of safety, 11 patients were treated with a dose of 1 x 106 cells per kg with a total volume of 68 mL, and 9 received 1 x 106 per kg at a volume of 40 mL (the dose being used in current phase 2 trials).
The median follow-up at the time of data cutoff in September 2020 was 36.1 months.
The combined CR/CRi rate was 75% for patients treated at the starting dose, 64% for patients treated at the 1 x 106 68-mL dose, and 67% for those who received the 48-mL dose.
The respective median durations of response were 4.14 months, 10.68 months, and not reached.
All patients who had an objective response had undetectable MRD assessed by flow cytometry with a sensitivity of .01%.
The therapy served as a bridge to allogeneic transplant in 16 patients, including 2 in the initial dose group, 8 in the 68-mL group, and 6 in the 40-mL group.
Median overall survival was not reached in either of the two 1 x 106–dose groups, but was 8 months in the 2 x 106 group.
There were no dose-limiting toxicities seen, and the adverse event profile was consistent with that seen with the use of CAR T therapy for other malignancies.
Patients treated at either the 68-mL or 40-mL 1 x 106–dose levels received tocilizumab only for neurologic events occurring in context with the cytokine release syndrome (CRS), and were started on steroids for grade 2 or greater neurologic events.
Rates of grade 3 or greater neurologic events were 25% in the initial-dose group, 27% in the 68-mL group, and 11% in the 40-mL group. Respective rates of grade 3 or greater CRS were 75%, 27%, and 22%.
Four patients died on study, all from causes deemed unrelated to CAR T therapy: two from progressive disease, one from disseminated mucormycosis, and one from Escherichia sepsis.
Investigators are currently enrolling pediatric patients with relapsed/refractory B-ALL or non-Hodgkin lymphoma, including patients with MRD-positive disease and early relapse after first-line therapy, in phase 2 of the Zuma-4 study.
How long will it last?
Howard Weinstein, MD, chief of pediatric hematology/oncology at Mass General for Children in Boston, who was not involved in the study, said in an interview that the response rate and comparatively low toxicity profile look good.
“One of the challenges, though, with CAR T-cell products has been relapse – almost half of the patients who go into remission relapse. Sometimes leukemic cells change their surface properties, resulting in antigen loss, there’s T-cell exhaustion, and other postulates for relapse,” he said.
He noted that due to the high number of patients who went on to transplant, the study lacks good data on the durability of remissions.
“One of the unknowns at the moment is whether CAR T cells are sufficient to cure a high percentage of children who have had a relapse, or do you need to follow it with a bone marrow transplant,” Dr. Weinstein said.
The ZUMA-4 trial is sponsored by Kite Pharma. Dr. Wayne disclosed research funding from Kite, Servier, and Institut de Recherches Internationales. Dr. Weinstein had no relevant disclosures.
It’s early days, but preliminary data show that a chimeric antigen receptor T-cell therapy (CAR T) product was associated with high rates of minimal residual disease (MRD) negativity, and complete or near-complete responses in children and adolescents with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL).
Among 24 patients aged 3-20 years with relapsed or refractory B-ALL treated with the CAR T construct brexucabtagene autoleucel (KTE-X19; Tecartus), 16 had either a complete response or CR with incomplete recovery of blood counts (CRi), for a combined CR/CRi rate of 67%, reported Alan S. Wayne, MD, from Children’s Hospital Los Angeles and the University of Southern California Norris Comprehensive Cancer Center, also in Los Angeles.
“Optimized KTE-X19 formulation of 40 mL and revised toxicity management were associated with an improved risk/benefit profile,” he said in audio narration accompanying a poster presented during the annual meeting of the American Society of Pediatric Hematology/Oncology.
Although overall survival for children and adolescents receiving first-line therapy for B-ALL is associated with remission rates of 80% or more, the prognosis is poor following relapse, despite the availability of newer therapies such as blinatumomab (Blincyto) and inotuzumab (Besponsa), with a 1-year overall survival rate of approximately 36%, he said.
To see whether they could improve on these odds, Dr. Wayne and colleagues conducted the phase 1 Zuma-4 trial, a single-arm, open-label study in children and adolescents with relapsed/refractory B-ALL.
He reported long-term follow-up results from the study.
Zuma-4 details
A total of 24 patients, median age 14 (range 3 to 20) years, received the CAR T product. Four patients received the starting dose of 2 x 106 CAR T per kg (these patients were enrolled per protocol for evaluation of dose-limiting toxicities).
Following the initial dosing and evaluation of safety, 11 patients were treated with a dose of 1 x 106 cells per kg with a total volume of 68 mL, and 9 received 1 x 106 per kg at a volume of 40 mL (the dose being used in current phase 2 trials).
The median follow-up at the time of data cutoff in September 2020 was 36.1 months.
The combined CR/CRi rate was 75% for patients treated at the starting dose, 64% for patients treated at the 1 x 106 68-mL dose, and 67% for those who received the 48-mL dose.
The respective median durations of response were 4.14 months, 10.68 months, and not reached.
All patients who had an objective response had undetectable MRD assessed by flow cytometry with a sensitivity of .01%.
The therapy served as a bridge to allogeneic transplant in 16 patients, including 2 in the initial dose group, 8 in the 68-mL group, and 6 in the 40-mL group.
Median overall survival was not reached in either of the two 1 x 106–dose groups, but was 8 months in the 2 x 106 group.
There were no dose-limiting toxicities seen, and the adverse event profile was consistent with that seen with the use of CAR T therapy for other malignancies.
Patients treated at either the 68-mL or 40-mL 1 x 106–dose levels received tocilizumab only for neurologic events occurring in context with the cytokine release syndrome (CRS), and were started on steroids for grade 2 or greater neurologic events.
Rates of grade 3 or greater neurologic events were 25% in the initial-dose group, 27% in the 68-mL group, and 11% in the 40-mL group. Respective rates of grade 3 or greater CRS were 75%, 27%, and 22%.
Four patients died on study, all from causes deemed unrelated to CAR T therapy: two from progressive disease, one from disseminated mucormycosis, and one from Escherichia sepsis.
Investigators are currently enrolling pediatric patients with relapsed/refractory B-ALL or non-Hodgkin lymphoma, including patients with MRD-positive disease and early relapse after first-line therapy, in phase 2 of the Zuma-4 study.
How long will it last?
Howard Weinstein, MD, chief of pediatric hematology/oncology at Mass General for Children in Boston, who was not involved in the study, said in an interview that the response rate and comparatively low toxicity profile look good.
“One of the challenges, though, with CAR T-cell products has been relapse – almost half of the patients who go into remission relapse. Sometimes leukemic cells change their surface properties, resulting in antigen loss, there’s T-cell exhaustion, and other postulates for relapse,” he said.
He noted that due to the high number of patients who went on to transplant, the study lacks good data on the durability of remissions.
“One of the unknowns at the moment is whether CAR T cells are sufficient to cure a high percentage of children who have had a relapse, or do you need to follow it with a bone marrow transplant,” Dr. Weinstein said.
The ZUMA-4 trial is sponsored by Kite Pharma. Dr. Wayne disclosed research funding from Kite, Servier, and Institut de Recherches Internationales. Dr. Weinstein had no relevant disclosures.
It’s early days, but preliminary data show that a chimeric antigen receptor T-cell therapy (CAR T) product was associated with high rates of minimal residual disease (MRD) negativity, and complete or near-complete responses in children and adolescents with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL).
Among 24 patients aged 3-20 years with relapsed or refractory B-ALL treated with the CAR T construct brexucabtagene autoleucel (KTE-X19; Tecartus), 16 had either a complete response or CR with incomplete recovery of blood counts (CRi), for a combined CR/CRi rate of 67%, reported Alan S. Wayne, MD, from Children’s Hospital Los Angeles and the University of Southern California Norris Comprehensive Cancer Center, also in Los Angeles.
“Optimized KTE-X19 formulation of 40 mL and revised toxicity management were associated with an improved risk/benefit profile,” he said in audio narration accompanying a poster presented during the annual meeting of the American Society of Pediatric Hematology/Oncology.
Although overall survival for children and adolescents receiving first-line therapy for B-ALL is associated with remission rates of 80% or more, the prognosis is poor following relapse, despite the availability of newer therapies such as blinatumomab (Blincyto) and inotuzumab (Besponsa), with a 1-year overall survival rate of approximately 36%, he said.
To see whether they could improve on these odds, Dr. Wayne and colleagues conducted the phase 1 Zuma-4 trial, a single-arm, open-label study in children and adolescents with relapsed/refractory B-ALL.
He reported long-term follow-up results from the study.
Zuma-4 details
A total of 24 patients, median age 14 (range 3 to 20) years, received the CAR T product. Four patients received the starting dose of 2 x 106 CAR T per kg (these patients were enrolled per protocol for evaluation of dose-limiting toxicities).
Following the initial dosing and evaluation of safety, 11 patients were treated with a dose of 1 x 106 cells per kg with a total volume of 68 mL, and 9 received 1 x 106 per kg at a volume of 40 mL (the dose being used in current phase 2 trials).
The median follow-up at the time of data cutoff in September 2020 was 36.1 months.
The combined CR/CRi rate was 75% for patients treated at the starting dose, 64% for patients treated at the 1 x 106 68-mL dose, and 67% for those who received the 48-mL dose.
The respective median durations of response were 4.14 months, 10.68 months, and not reached.
All patients who had an objective response had undetectable MRD assessed by flow cytometry with a sensitivity of .01%.
The therapy served as a bridge to allogeneic transplant in 16 patients, including 2 in the initial dose group, 8 in the 68-mL group, and 6 in the 40-mL group.
Median overall survival was not reached in either of the two 1 x 106–dose groups, but was 8 months in the 2 x 106 group.
There were no dose-limiting toxicities seen, and the adverse event profile was consistent with that seen with the use of CAR T therapy for other malignancies.
Patients treated at either the 68-mL or 40-mL 1 x 106–dose levels received tocilizumab only for neurologic events occurring in context with the cytokine release syndrome (CRS), and were started on steroids for grade 2 or greater neurologic events.
Rates of grade 3 or greater neurologic events were 25% in the initial-dose group, 27% in the 68-mL group, and 11% in the 40-mL group. Respective rates of grade 3 or greater CRS were 75%, 27%, and 22%.
Four patients died on study, all from causes deemed unrelated to CAR T therapy: two from progressive disease, one from disseminated mucormycosis, and one from Escherichia sepsis.
Investigators are currently enrolling pediatric patients with relapsed/refractory B-ALL or non-Hodgkin lymphoma, including patients with MRD-positive disease and early relapse after first-line therapy, in phase 2 of the Zuma-4 study.
How long will it last?
Howard Weinstein, MD, chief of pediatric hematology/oncology at Mass General for Children in Boston, who was not involved in the study, said in an interview that the response rate and comparatively low toxicity profile look good.
“One of the challenges, though, with CAR T-cell products has been relapse – almost half of the patients who go into remission relapse. Sometimes leukemic cells change their surface properties, resulting in antigen loss, there’s T-cell exhaustion, and other postulates for relapse,” he said.
He noted that due to the high number of patients who went on to transplant, the study lacks good data on the durability of remissions.
“One of the unknowns at the moment is whether CAR T cells are sufficient to cure a high percentage of children who have had a relapse, or do you need to follow it with a bone marrow transplant,” Dr. Weinstein said.
The ZUMA-4 trial is sponsored by Kite Pharma. Dr. Wayne disclosed research funding from Kite, Servier, and Institut de Recherches Internationales. Dr. Weinstein had no relevant disclosures.
FROM ASPHO 2021
National poll shows ‘concerning’ impact of COVID on Americans’ mental health
Concern and anxiety around COVID-19 remains high among Americans, with more people reporting mental health effects from the pandemic this year than last, and parents concerned about the mental health of their children, results of a new poll by the American Psychiatric Association show. Although the overall level of anxiety has decreased from last year’s APA poll, “the degree to which anxiety still reigns is concerning,” APA President Jeffrey Geller, MD, MPH, told this news organization.
The results of the latest poll were presented at the American Psychiatric Association 2021 annual meeting and based on an online survey conducted March 26 to April 5 among a sample of 1,000 adults aged 18 years or older.
Serious mental health hit
In the new poll, about 4 in 10 Americans (41%) report they are more anxious than last year, down from just over 60%.
Young adults aged 18-29 years (49%) and Hispanic/Latinos (50%) are more likely to report being more anxious now than a year ago. Those 65 or older (30%) are less apt to say they feel more anxious than last year.
The latest poll also shows that Americans are more anxious about family and loved ones getting COVID-19 (64%) than about catching the virus themselves (49%).
Concern about family and loved ones contracting COVID-19 has increased since last year’s poll (conducted September 2020), rising from 56% then to 64% now. Hispanic/Latinx individuals (73%) and African American/Black individuals (76%) are more anxious about COVID-19 than White people (59%).
In the new poll, 43% of adults report the pandemic has had a serious impact on their mental health, up from 37% in 2020. Younger adults are more apt than older adults to report serious mental health effects.
Slightly fewer Americans report the pandemic is affecting their day-to-day life now as compared to a year ago, in ways such as problems sleeping (19% down from 22%), difficulty concentrating (18% down from 20%), and fighting more with loved ones (16% down from 17%).
The percentage of adults consuming more alcohol or other substances/drugs than normal increased slightly since last year (14%-17%). Additionally, 33% of adults (40% of women) report gaining weight during the pandemic.
Call to action
More than half of adults (53%) with children report they are concerned about the mental state of their children and almost half (48%) report the pandemic has caused mental health problems for one or more of their children, including minor problems for 29% and major problems for 19%.
More than a quarter (26%) of parents have sought professional mental health help for their children because of the pandemic.
; 23% received help from a primary care professional, 18% from a psychiatrist, 15% from a psychologist, 13% from a therapist, 10% from a social worker, and 10% from a school counselor or school psychologist.
More than 1 in 5 parents reported difficulty scheduling appointments for their child with a mental health professional.
“This poll shows that, even as vaccines become more widespread, Americans are still worried about the mental state of their children,” Dr. Geller said in a news release.
“This is a call to action for policymakers, who need to remember that, in our COVID-19 recovery, there’s no health without mental health,” he added.
Just over three-quarters (76%) of those surveyed say they have been or intend to get vaccinated; 22% say they don’t intend to get vaccinated; and 2% didn’t know.
For those who do not intend to get vaccinated, the primary concern (53%) is about side effects of the vaccine. Other reasons for not getting vaccinated include believing the vaccine is not effective (31%), believing the makers of the vaccine aren’t being honest about what’s in it (27%), and fear/anxiety about needles (12%).
Resiliency a finite resource
Reached for comment, Samoon Ahmad, MD, professor in the department of psychiatry, New York University, said it’s not surprising that Americans are still suffering more anxiety than normal.
“The Census Bureau’s Household Pulse Survey has shown that anxiety and depression levels have remained higher than normal since the pandemic began. That 43% of adults now say that the pandemic has had a serious impact on their mental health seems in line with what that survey has been reporting for over a year,” Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York, said in an interview.
He believes there are several reasons why anxiety levels remain high. One reason is something he’s noticed among his patients for years. “Most people struggle with anxiety especially at night when the noise and distractions of contemporary life fade away. This is the time of introspection,” he explained.
“Quarantine has been kind of like a protracted night because the distractions that are common in the so-called ‘rat race’ have been relatively muted for the past 14 months. I believe this has caused what you might call ‘forced introspection,’ and that this is giving rise to feelings of anxiety as people use their time alone to reassess their careers and their social lives and really begin to fret about some of the decisions that have led them to this point in their lives,” said Dr. Ahmad.
The other finding in the APA survey – that people are more concerned about their loved ones catching the virus than they were a year ago – is also not surprising, Dr. Ahmad said.
“Even though we seem to have turned a corner in the United States and the worst of the pandemic is behind us, the surge that went from roughly November through March of this year was more wide-reaching geographically than previous waves, and I think this made the severity of the virus far more real to people who lived in communities that had been spared severe outbreaks during the surges that we saw in the spring and summer of 2020,” Dr. Ahmad told this news organization.
“There’s also heightened concern over variants and the efficacy of the vaccine in treating these variants. Those who have families in other countries where the virus is surging, such as India or parts of Latin America, are likely experiencing additional stress and anxiety too,” he noted.
While the new APA poll findings are not surprising, they still are “deeply concerning,” Dr. Ahmad said.
“Resiliency is a finite resource, and people can only take so much stress before their mental health begins to suffer. For most people, this is not going to lead to some kind of overdramatic nervous breakdown. Instead, one may notice that they are more irritable than they once were, that they’re not sleeping particularly well, or that they have a nagging sense of discomfort and stress when doing activities that they used to think of as normal,” like taking a trip to the grocery store, meeting up with friends, or going to work, Dr. Ahmad said.
“Overcoming this kind of anxiety and reacclimating ourselves to social situations is going to take more time for some people than others, and that is perfectly natural,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York.
“I don’t think it’s wise to try to put a limit on what constitutes a normal amount of time to readjust, and I think everyone in the field of mental health needs to avoid pathologizing any lingering sense of unease. No one needs to be medicated or diagnosed with a mental illness because they are nervous about going into public spaces in the immediate aftermath of a pandemic. We need to show a lot of patience and encourage people to readjust at their own pace for the foreseeable future,” Dr. Ahmad said.
Dr. Geller and Dr. Ahmad have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Concern and anxiety around COVID-19 remains high among Americans, with more people reporting mental health effects from the pandemic this year than last, and parents concerned about the mental health of their children, results of a new poll by the American Psychiatric Association show. Although the overall level of anxiety has decreased from last year’s APA poll, “the degree to which anxiety still reigns is concerning,” APA President Jeffrey Geller, MD, MPH, told this news organization.
The results of the latest poll were presented at the American Psychiatric Association 2021 annual meeting and based on an online survey conducted March 26 to April 5 among a sample of 1,000 adults aged 18 years or older.
Serious mental health hit
In the new poll, about 4 in 10 Americans (41%) report they are more anxious than last year, down from just over 60%.
Young adults aged 18-29 years (49%) and Hispanic/Latinos (50%) are more likely to report being more anxious now than a year ago. Those 65 or older (30%) are less apt to say they feel more anxious than last year.
The latest poll also shows that Americans are more anxious about family and loved ones getting COVID-19 (64%) than about catching the virus themselves (49%).
Concern about family and loved ones contracting COVID-19 has increased since last year’s poll (conducted September 2020), rising from 56% then to 64% now. Hispanic/Latinx individuals (73%) and African American/Black individuals (76%) are more anxious about COVID-19 than White people (59%).
In the new poll, 43% of adults report the pandemic has had a serious impact on their mental health, up from 37% in 2020. Younger adults are more apt than older adults to report serious mental health effects.
Slightly fewer Americans report the pandemic is affecting their day-to-day life now as compared to a year ago, in ways such as problems sleeping (19% down from 22%), difficulty concentrating (18% down from 20%), and fighting more with loved ones (16% down from 17%).
The percentage of adults consuming more alcohol or other substances/drugs than normal increased slightly since last year (14%-17%). Additionally, 33% of adults (40% of women) report gaining weight during the pandemic.
Call to action
More than half of adults (53%) with children report they are concerned about the mental state of their children and almost half (48%) report the pandemic has caused mental health problems for one or more of their children, including minor problems for 29% and major problems for 19%.
More than a quarter (26%) of parents have sought professional mental health help for their children because of the pandemic.
; 23% received help from a primary care professional, 18% from a psychiatrist, 15% from a psychologist, 13% from a therapist, 10% from a social worker, and 10% from a school counselor or school psychologist.
More than 1 in 5 parents reported difficulty scheduling appointments for their child with a mental health professional.
“This poll shows that, even as vaccines become more widespread, Americans are still worried about the mental state of their children,” Dr. Geller said in a news release.
“This is a call to action for policymakers, who need to remember that, in our COVID-19 recovery, there’s no health without mental health,” he added.
Just over three-quarters (76%) of those surveyed say they have been or intend to get vaccinated; 22% say they don’t intend to get vaccinated; and 2% didn’t know.
For those who do not intend to get vaccinated, the primary concern (53%) is about side effects of the vaccine. Other reasons for not getting vaccinated include believing the vaccine is not effective (31%), believing the makers of the vaccine aren’t being honest about what’s in it (27%), and fear/anxiety about needles (12%).
Resiliency a finite resource
Reached for comment, Samoon Ahmad, MD, professor in the department of psychiatry, New York University, said it’s not surprising that Americans are still suffering more anxiety than normal.
“The Census Bureau’s Household Pulse Survey has shown that anxiety and depression levels have remained higher than normal since the pandemic began. That 43% of adults now say that the pandemic has had a serious impact on their mental health seems in line with what that survey has been reporting for over a year,” Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York, said in an interview.
He believes there are several reasons why anxiety levels remain high. One reason is something he’s noticed among his patients for years. “Most people struggle with anxiety especially at night when the noise and distractions of contemporary life fade away. This is the time of introspection,” he explained.
“Quarantine has been kind of like a protracted night because the distractions that are common in the so-called ‘rat race’ have been relatively muted for the past 14 months. I believe this has caused what you might call ‘forced introspection,’ and that this is giving rise to feelings of anxiety as people use their time alone to reassess their careers and their social lives and really begin to fret about some of the decisions that have led them to this point in their lives,” said Dr. Ahmad.
The other finding in the APA survey – that people are more concerned about their loved ones catching the virus than they were a year ago – is also not surprising, Dr. Ahmad said.
“Even though we seem to have turned a corner in the United States and the worst of the pandemic is behind us, the surge that went from roughly November through March of this year was more wide-reaching geographically than previous waves, and I think this made the severity of the virus far more real to people who lived in communities that had been spared severe outbreaks during the surges that we saw in the spring and summer of 2020,” Dr. Ahmad told this news organization.
“There’s also heightened concern over variants and the efficacy of the vaccine in treating these variants. Those who have families in other countries where the virus is surging, such as India or parts of Latin America, are likely experiencing additional stress and anxiety too,” he noted.
While the new APA poll findings are not surprising, they still are “deeply concerning,” Dr. Ahmad said.
“Resiliency is a finite resource, and people can only take so much stress before their mental health begins to suffer. For most people, this is not going to lead to some kind of overdramatic nervous breakdown. Instead, one may notice that they are more irritable than they once were, that they’re not sleeping particularly well, or that they have a nagging sense of discomfort and stress when doing activities that they used to think of as normal,” like taking a trip to the grocery store, meeting up with friends, or going to work, Dr. Ahmad said.
“Overcoming this kind of anxiety and reacclimating ourselves to social situations is going to take more time for some people than others, and that is perfectly natural,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York.
“I don’t think it’s wise to try to put a limit on what constitutes a normal amount of time to readjust, and I think everyone in the field of mental health needs to avoid pathologizing any lingering sense of unease. No one needs to be medicated or diagnosed with a mental illness because they are nervous about going into public spaces in the immediate aftermath of a pandemic. We need to show a lot of patience and encourage people to readjust at their own pace for the foreseeable future,” Dr. Ahmad said.
Dr. Geller and Dr. Ahmad have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Concern and anxiety around COVID-19 remains high among Americans, with more people reporting mental health effects from the pandemic this year than last, and parents concerned about the mental health of their children, results of a new poll by the American Psychiatric Association show. Although the overall level of anxiety has decreased from last year’s APA poll, “the degree to which anxiety still reigns is concerning,” APA President Jeffrey Geller, MD, MPH, told this news organization.
The results of the latest poll were presented at the American Psychiatric Association 2021 annual meeting and based on an online survey conducted March 26 to April 5 among a sample of 1,000 adults aged 18 years or older.
Serious mental health hit
In the new poll, about 4 in 10 Americans (41%) report they are more anxious than last year, down from just over 60%.
Young adults aged 18-29 years (49%) and Hispanic/Latinos (50%) are more likely to report being more anxious now than a year ago. Those 65 or older (30%) are less apt to say they feel more anxious than last year.
The latest poll also shows that Americans are more anxious about family and loved ones getting COVID-19 (64%) than about catching the virus themselves (49%).
Concern about family and loved ones contracting COVID-19 has increased since last year’s poll (conducted September 2020), rising from 56% then to 64% now. Hispanic/Latinx individuals (73%) and African American/Black individuals (76%) are more anxious about COVID-19 than White people (59%).
In the new poll, 43% of adults report the pandemic has had a serious impact on their mental health, up from 37% in 2020. Younger adults are more apt than older adults to report serious mental health effects.
Slightly fewer Americans report the pandemic is affecting their day-to-day life now as compared to a year ago, in ways such as problems sleeping (19% down from 22%), difficulty concentrating (18% down from 20%), and fighting more with loved ones (16% down from 17%).
The percentage of adults consuming more alcohol or other substances/drugs than normal increased slightly since last year (14%-17%). Additionally, 33% of adults (40% of women) report gaining weight during the pandemic.
Call to action
More than half of adults (53%) with children report they are concerned about the mental state of their children and almost half (48%) report the pandemic has caused mental health problems for one or more of their children, including minor problems for 29% and major problems for 19%.
More than a quarter (26%) of parents have sought professional mental health help for their children because of the pandemic.
; 23% received help from a primary care professional, 18% from a psychiatrist, 15% from a psychologist, 13% from a therapist, 10% from a social worker, and 10% from a school counselor or school psychologist.
More than 1 in 5 parents reported difficulty scheduling appointments for their child with a mental health professional.
“This poll shows that, even as vaccines become more widespread, Americans are still worried about the mental state of their children,” Dr. Geller said in a news release.
“This is a call to action for policymakers, who need to remember that, in our COVID-19 recovery, there’s no health without mental health,” he added.
Just over three-quarters (76%) of those surveyed say they have been or intend to get vaccinated; 22% say they don’t intend to get vaccinated; and 2% didn’t know.
For those who do not intend to get vaccinated, the primary concern (53%) is about side effects of the vaccine. Other reasons for not getting vaccinated include believing the vaccine is not effective (31%), believing the makers of the vaccine aren’t being honest about what’s in it (27%), and fear/anxiety about needles (12%).
Resiliency a finite resource
Reached for comment, Samoon Ahmad, MD, professor in the department of psychiatry, New York University, said it’s not surprising that Americans are still suffering more anxiety than normal.
“The Census Bureau’s Household Pulse Survey has shown that anxiety and depression levels have remained higher than normal since the pandemic began. That 43% of adults now say that the pandemic has had a serious impact on their mental health seems in line with what that survey has been reporting for over a year,” Dr. Ahmad, who serves as unit chief of inpatient psychiatry at Bellevue Hospital Center in New York, said in an interview.
He believes there are several reasons why anxiety levels remain high. One reason is something he’s noticed among his patients for years. “Most people struggle with anxiety especially at night when the noise and distractions of contemporary life fade away. This is the time of introspection,” he explained.
“Quarantine has been kind of like a protracted night because the distractions that are common in the so-called ‘rat race’ have been relatively muted for the past 14 months. I believe this has caused what you might call ‘forced introspection,’ and that this is giving rise to feelings of anxiety as people use their time alone to reassess their careers and their social lives and really begin to fret about some of the decisions that have led them to this point in their lives,” said Dr. Ahmad.
The other finding in the APA survey – that people are more concerned about their loved ones catching the virus than they were a year ago – is also not surprising, Dr. Ahmad said.
“Even though we seem to have turned a corner in the United States and the worst of the pandemic is behind us, the surge that went from roughly November through March of this year was more wide-reaching geographically than previous waves, and I think this made the severity of the virus far more real to people who lived in communities that had been spared severe outbreaks during the surges that we saw in the spring and summer of 2020,” Dr. Ahmad told this news organization.
“There’s also heightened concern over variants and the efficacy of the vaccine in treating these variants. Those who have families in other countries where the virus is surging, such as India or parts of Latin America, are likely experiencing additional stress and anxiety too,” he noted.
While the new APA poll findings are not surprising, they still are “deeply concerning,” Dr. Ahmad said.
“Resiliency is a finite resource, and people can only take so much stress before their mental health begins to suffer. For most people, this is not going to lead to some kind of overdramatic nervous breakdown. Instead, one may notice that they are more irritable than they once were, that they’re not sleeping particularly well, or that they have a nagging sense of discomfort and stress when doing activities that they used to think of as normal,” like taking a trip to the grocery store, meeting up with friends, or going to work, Dr. Ahmad said.
“Overcoming this kind of anxiety and reacclimating ourselves to social situations is going to take more time for some people than others, and that is perfectly natural,” said Dr. Ahmad, founder of the Integrative Center for Wellness in New York.
“I don’t think it’s wise to try to put a limit on what constitutes a normal amount of time to readjust, and I think everyone in the field of mental health needs to avoid pathologizing any lingering sense of unease. No one needs to be medicated or diagnosed with a mental illness because they are nervous about going into public spaces in the immediate aftermath of a pandemic. We need to show a lot of patience and encourage people to readjust at their own pace for the foreseeable future,” Dr. Ahmad said.
Dr. Geller and Dr. Ahmad have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Baricitinib continuation rate high in real-world practice
Around three-quarters of patients remained on treatment with baricitinib (Olumiant) for rheumatoid arthritis after their first 6-month assessment in an independent analysis of British Society for Rheumatology Biologics Register (BSRBR) data.
The rate of continuation was even higher, at almost 85%, in patients who had not previously been treated with a biologic or targeted synthetic disease-modifying antirheumatic drug (b/ts DMARD) before being given baricitinib. The 6-month continuation rate was also higher, at 80%, in patients who received baricitinib without additional DMARDs or steroid therapy.
Overall, the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) score was reduced from a baseline of 5.7 to 3.4, with similar reductions seen among the subgroups of patients who had received baricitinib as monotherapy, after prior b/tsDMARDs, or no prior b/tsDMARDs.
“We’ve looked at an RA study population using data from the BSR biologics registry, to try and have a look at how patients with baricitinib are being treated and how they’re doing in this real-world setting, within the U.K.,” explained consultant rheumatologist Christopher J. Edwards, MD, of University Hospital Southampton (England) at the British Society for Rheumatology annual conference.
“Overall, effectiveness and tolerability seem to be pretty good indeed,” he said. “Sample size, of course, was small and it will be nice to see a little bit more data collected over time that allow us to be more confident in any conclusions.”
‘Getting to grips’ with baricitinib
Baricitinib is a drug that clinicians in the United Kingdom are “just getting to grips with,” observed Jon Packham, BM, DM, a consultant rheumatologist at Haywood Hospital in Stoke-on-Trent (England) who was not involved in the analysis.
“We look forward to when we’ve got a few more patients through that 6-month hurdle and we were getting even more data coming through,” Dr. Packham said.
Baricitinib was given marketing authorization in Europe for the treatment of moderate to severe RA in 2017 and so is a relatively new addition into the BSRBR-RA, which has been running for the past 20 years. It includes data on patients with RA who are newly starting a bDMARD or tsDMARD, and patients are followed up every 6 months for the first 3 years of their treatment and then annually thereafter.
Dr. Edwards presented data on some of the baseline characteristics and status of patients at the first 6-month follow-up of the BSRBR-RA. He was clear that this analysis was done independently of the BSRBR-RA study team and performed under an agreement between Eli Lilly and the BSR to allow access to the data.
Between Jan. 1, 2018, and March 31, 2019, there were 409 patients who were just starting baricitinib treatment and who were entered into the BSRBR-RA. The mean age of patients was 61 years, and the majority (76%) was female. On average, patients starting baricitinib had been diagnosed with RA for 11 years, and 62% had previously been treated with a biologic.
As per the European label, most patients were being treated with baricitinib in combination with a conventional synthetic DMARD (61%), with 40% of patients receiving it in combination with methotrexate. Around 38% of patients received baricitinib as monotherapy, and just under 30% were receiving concomitant glucocorticoids.
The majority (84%) were prescribed a 4-mg daily dose of baricitinib, with the remainder on a daily dose of 2 mg.
There were 163 patients with data available at the first 6-month follow up, and of those, 103 had prior experience of being treated with a b/ts DMARD, 59 did not, and 65 had been given baricitinib as monotherapy.
Reasons for discontinuation
Overall, around a quarter of patients discontinued treatment with baricitinib, and “the reasons for this were lack of efficacy in approximately a quarter and adverse events in about two-thirds of the patients,” Dr. Edwards said.
Breaking down the types of adverse events was not part of this analysis, and that information is likely to come from the BSRBR-RA study team directly.
“We have some experience in our practice in Southampton,” Dr. Edwards observed. This experience was outlined in a separate abstract at the meeting and presented by Dr. May Nwe Lwin, a clinical research fellow within Dr. Edwards’ group.
Dr. Lwin presented data on 83 patients who had received baricitinib at University Hospital Southampton between October 2017 and July 2020, 55 (65.2%) of whom remain on treatment to date, with mean follow-up of 17 months. Of the 28 patients who stopped baricitinib, 21 stopped within 12 months.
“Patients who continued on baricitinib appeared more likely to be older and female,” Dr. Lwin said.
The mean age of patients who continued on treatment after 12 months was 61.5 years but was 49 years for those who stopped earlier. The percentage of women continuing treatment at 12 months versus those stopping earlier were a respective 82% and 67%. Both findings were significant (P < .001) but “could mean nothing, or could be very interesting data to explore more,” Dr. Lwin suggested.
“However, there was no significant difference in discontinuation rates for those using mono or combination therapy, and also no effect of disease duration or seropositivity,” Dr. Lwin said.
“Most people stopped baricitinib in the first 3 months of their treatment,” Dr. Lwin reported, noting that the most common reason was a lack of efficacy in 64% of patients, with 28.5% of patients discontinuing because of side effects.
“When you look at the adverse events, the reasons for discontinuation are quite variable,” Dr. Lwin said. These included infections (one urinary tract infection, two chest infections, and a urinary tract infection), and one case each of discitis, deranged liver function, lymphoma, and personality change.
Update on the long-term safety profile
Also at the BSR annual conference, an update on the long-term safety profile of baricitinib seen in clinical trials was presented, using data from the ‘All-BARI-RA’ dataset. This includes data from nine clinical trials and one long-term extension study.
“We recently published a long-term safety analysis of this molecule involving 3,700-plus patients with exposure up to 7 years,” said Kevin L. Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health Sciences University in Portland.
Dr. Winthrop provided an update on this, adding in another 13,148 patient-years of follow-up and giving data on the safety experience with baricitinib with up to 8.4 years of exposure for some patients.
“In short, not much has changed,” Dr. Winthrop said, noting that event rates have remained stable.
The overall major adverse cardiovascular event (MACE) and overall deep vein thrombosis/pulmonary embolism event rate were both 0.5 per 100 patient-years. Referring to the latter, Dr. Winthrop called them “rock solid stable” and “it’s been that way really all the way through the development program.”
Overall, event rates per 100 patient-years for serious infections, herpes zoster, and tuberculosis were a respective 2.7, 3.0, and 0.2. Serious infection rates over time have remained similar, but “clearly age is a risk factor for infection,” Dr. Winthrop said. “I would just say it’s similar to what we see with all biologics and small molecules in this setting.”
Malignancy and death rates were also higher in older patients, but after age adjustment, these had been stable across the different analysis points.
“Malignancy overall, excluding NMSC [nonmelanoma skin cancer], the event rate is 0.9 per 100 patient-years, very similar to what we’ve seen in the prior data cuts,” he said. “The same is true for lymphoma,” he added, with an overall event rate of 0.1 per 100 patient-years.
This updated analysis, Dr. Winthrop concluded, “suggests a safety profile really very similar to what was published recently.”Dr. Edwards has received research and educational grants and advisory panel and speaker fees from Eli Lilly and from multiple other pharmaceutical companies. The analysis of BSRBR-RA data he presented was sponsored by Eli Lilly and performed independently of the BSRBR-RA study team. Dr. Packham reported no conflicts of interest; he chaired the oral abstracts sessions in which Dr. Edwards presented his findings.
Dr. Lwin did not report having any disclosures.
Dr. Winthrop has acted as a consultant to Eli Lilly and several other pharmaceutical companies and had received research or grant support from Bristol-Myers Squibb and Pfizer. The work he presented was sponsored by Eli Lilly.
Around three-quarters of patients remained on treatment with baricitinib (Olumiant) for rheumatoid arthritis after their first 6-month assessment in an independent analysis of British Society for Rheumatology Biologics Register (BSRBR) data.
The rate of continuation was even higher, at almost 85%, in patients who had not previously been treated with a biologic or targeted synthetic disease-modifying antirheumatic drug (b/ts DMARD) before being given baricitinib. The 6-month continuation rate was also higher, at 80%, in patients who received baricitinib without additional DMARDs or steroid therapy.
Overall, the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) score was reduced from a baseline of 5.7 to 3.4, with similar reductions seen among the subgroups of patients who had received baricitinib as monotherapy, after prior b/tsDMARDs, or no prior b/tsDMARDs.
“We’ve looked at an RA study population using data from the BSR biologics registry, to try and have a look at how patients with baricitinib are being treated and how they’re doing in this real-world setting, within the U.K.,” explained consultant rheumatologist Christopher J. Edwards, MD, of University Hospital Southampton (England) at the British Society for Rheumatology annual conference.
“Overall, effectiveness and tolerability seem to be pretty good indeed,” he said. “Sample size, of course, was small and it will be nice to see a little bit more data collected over time that allow us to be more confident in any conclusions.”
‘Getting to grips’ with baricitinib
Baricitinib is a drug that clinicians in the United Kingdom are “just getting to grips with,” observed Jon Packham, BM, DM, a consultant rheumatologist at Haywood Hospital in Stoke-on-Trent (England) who was not involved in the analysis.
“We look forward to when we’ve got a few more patients through that 6-month hurdle and we were getting even more data coming through,” Dr. Packham said.
Baricitinib was given marketing authorization in Europe for the treatment of moderate to severe RA in 2017 and so is a relatively new addition into the BSRBR-RA, which has been running for the past 20 years. It includes data on patients with RA who are newly starting a bDMARD or tsDMARD, and patients are followed up every 6 months for the first 3 years of their treatment and then annually thereafter.
Dr. Edwards presented data on some of the baseline characteristics and status of patients at the first 6-month follow-up of the BSRBR-RA. He was clear that this analysis was done independently of the BSRBR-RA study team and performed under an agreement between Eli Lilly and the BSR to allow access to the data.
Between Jan. 1, 2018, and March 31, 2019, there were 409 patients who were just starting baricitinib treatment and who were entered into the BSRBR-RA. The mean age of patients was 61 years, and the majority (76%) was female. On average, patients starting baricitinib had been diagnosed with RA for 11 years, and 62% had previously been treated with a biologic.
As per the European label, most patients were being treated with baricitinib in combination with a conventional synthetic DMARD (61%), with 40% of patients receiving it in combination with methotrexate. Around 38% of patients received baricitinib as monotherapy, and just under 30% were receiving concomitant glucocorticoids.
The majority (84%) were prescribed a 4-mg daily dose of baricitinib, with the remainder on a daily dose of 2 mg.
There were 163 patients with data available at the first 6-month follow up, and of those, 103 had prior experience of being treated with a b/ts DMARD, 59 did not, and 65 had been given baricitinib as monotherapy.
Reasons for discontinuation
Overall, around a quarter of patients discontinued treatment with baricitinib, and “the reasons for this were lack of efficacy in approximately a quarter and adverse events in about two-thirds of the patients,” Dr. Edwards said.
Breaking down the types of adverse events was not part of this analysis, and that information is likely to come from the BSRBR-RA study team directly.
“We have some experience in our practice in Southampton,” Dr. Edwards observed. This experience was outlined in a separate abstract at the meeting and presented by Dr. May Nwe Lwin, a clinical research fellow within Dr. Edwards’ group.
Dr. Lwin presented data on 83 patients who had received baricitinib at University Hospital Southampton between October 2017 and July 2020, 55 (65.2%) of whom remain on treatment to date, with mean follow-up of 17 months. Of the 28 patients who stopped baricitinib, 21 stopped within 12 months.
“Patients who continued on baricitinib appeared more likely to be older and female,” Dr. Lwin said.
The mean age of patients who continued on treatment after 12 months was 61.5 years but was 49 years for those who stopped earlier. The percentage of women continuing treatment at 12 months versus those stopping earlier were a respective 82% and 67%. Both findings were significant (P < .001) but “could mean nothing, or could be very interesting data to explore more,” Dr. Lwin suggested.
“However, there was no significant difference in discontinuation rates for those using mono or combination therapy, and also no effect of disease duration or seropositivity,” Dr. Lwin said.
“Most people stopped baricitinib in the first 3 months of their treatment,” Dr. Lwin reported, noting that the most common reason was a lack of efficacy in 64% of patients, with 28.5% of patients discontinuing because of side effects.
“When you look at the adverse events, the reasons for discontinuation are quite variable,” Dr. Lwin said. These included infections (one urinary tract infection, two chest infections, and a urinary tract infection), and one case each of discitis, deranged liver function, lymphoma, and personality change.
Update on the long-term safety profile
Also at the BSR annual conference, an update on the long-term safety profile of baricitinib seen in clinical trials was presented, using data from the ‘All-BARI-RA’ dataset. This includes data from nine clinical trials and one long-term extension study.
“We recently published a long-term safety analysis of this molecule involving 3,700-plus patients with exposure up to 7 years,” said Kevin L. Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health Sciences University in Portland.
Dr. Winthrop provided an update on this, adding in another 13,148 patient-years of follow-up and giving data on the safety experience with baricitinib with up to 8.4 years of exposure for some patients.
“In short, not much has changed,” Dr. Winthrop said, noting that event rates have remained stable.
The overall major adverse cardiovascular event (MACE) and overall deep vein thrombosis/pulmonary embolism event rate were both 0.5 per 100 patient-years. Referring to the latter, Dr. Winthrop called them “rock solid stable” and “it’s been that way really all the way through the development program.”
Overall, event rates per 100 patient-years for serious infections, herpes zoster, and tuberculosis were a respective 2.7, 3.0, and 0.2. Serious infection rates over time have remained similar, but “clearly age is a risk factor for infection,” Dr. Winthrop said. “I would just say it’s similar to what we see with all biologics and small molecules in this setting.”
Malignancy and death rates were also higher in older patients, but after age adjustment, these had been stable across the different analysis points.
“Malignancy overall, excluding NMSC [nonmelanoma skin cancer], the event rate is 0.9 per 100 patient-years, very similar to what we’ve seen in the prior data cuts,” he said. “The same is true for lymphoma,” he added, with an overall event rate of 0.1 per 100 patient-years.
This updated analysis, Dr. Winthrop concluded, “suggests a safety profile really very similar to what was published recently.”Dr. Edwards has received research and educational grants and advisory panel and speaker fees from Eli Lilly and from multiple other pharmaceutical companies. The analysis of BSRBR-RA data he presented was sponsored by Eli Lilly and performed independently of the BSRBR-RA study team. Dr. Packham reported no conflicts of interest; he chaired the oral abstracts sessions in which Dr. Edwards presented his findings.
Dr. Lwin did not report having any disclosures.
Dr. Winthrop has acted as a consultant to Eli Lilly and several other pharmaceutical companies and had received research or grant support from Bristol-Myers Squibb and Pfizer. The work he presented was sponsored by Eli Lilly.
Around three-quarters of patients remained on treatment with baricitinib (Olumiant) for rheumatoid arthritis after their first 6-month assessment in an independent analysis of British Society for Rheumatology Biologics Register (BSRBR) data.
The rate of continuation was even higher, at almost 85%, in patients who had not previously been treated with a biologic or targeted synthetic disease-modifying antirheumatic drug (b/ts DMARD) before being given baricitinib. The 6-month continuation rate was also higher, at 80%, in patients who received baricitinib without additional DMARDs or steroid therapy.
Overall, the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) score was reduced from a baseline of 5.7 to 3.4, with similar reductions seen among the subgroups of patients who had received baricitinib as monotherapy, after prior b/tsDMARDs, or no prior b/tsDMARDs.
“We’ve looked at an RA study population using data from the BSR biologics registry, to try and have a look at how patients with baricitinib are being treated and how they’re doing in this real-world setting, within the U.K.,” explained consultant rheumatologist Christopher J. Edwards, MD, of University Hospital Southampton (England) at the British Society for Rheumatology annual conference.
“Overall, effectiveness and tolerability seem to be pretty good indeed,” he said. “Sample size, of course, was small and it will be nice to see a little bit more data collected over time that allow us to be more confident in any conclusions.”
‘Getting to grips’ with baricitinib
Baricitinib is a drug that clinicians in the United Kingdom are “just getting to grips with,” observed Jon Packham, BM, DM, a consultant rheumatologist at Haywood Hospital in Stoke-on-Trent (England) who was not involved in the analysis.
“We look forward to when we’ve got a few more patients through that 6-month hurdle and we were getting even more data coming through,” Dr. Packham said.
Baricitinib was given marketing authorization in Europe for the treatment of moderate to severe RA in 2017 and so is a relatively new addition into the BSRBR-RA, which has been running for the past 20 years. It includes data on patients with RA who are newly starting a bDMARD or tsDMARD, and patients are followed up every 6 months for the first 3 years of their treatment and then annually thereafter.
Dr. Edwards presented data on some of the baseline characteristics and status of patients at the first 6-month follow-up of the BSRBR-RA. He was clear that this analysis was done independently of the BSRBR-RA study team and performed under an agreement between Eli Lilly and the BSR to allow access to the data.
Between Jan. 1, 2018, and March 31, 2019, there were 409 patients who were just starting baricitinib treatment and who were entered into the BSRBR-RA. The mean age of patients was 61 years, and the majority (76%) was female. On average, patients starting baricitinib had been diagnosed with RA for 11 years, and 62% had previously been treated with a biologic.
As per the European label, most patients were being treated with baricitinib in combination with a conventional synthetic DMARD (61%), with 40% of patients receiving it in combination with methotrexate. Around 38% of patients received baricitinib as monotherapy, and just under 30% were receiving concomitant glucocorticoids.
The majority (84%) were prescribed a 4-mg daily dose of baricitinib, with the remainder on a daily dose of 2 mg.
There were 163 patients with data available at the first 6-month follow up, and of those, 103 had prior experience of being treated with a b/ts DMARD, 59 did not, and 65 had been given baricitinib as monotherapy.
Reasons for discontinuation
Overall, around a quarter of patients discontinued treatment with baricitinib, and “the reasons for this were lack of efficacy in approximately a quarter and adverse events in about two-thirds of the patients,” Dr. Edwards said.
Breaking down the types of adverse events was not part of this analysis, and that information is likely to come from the BSRBR-RA study team directly.
“We have some experience in our practice in Southampton,” Dr. Edwards observed. This experience was outlined in a separate abstract at the meeting and presented by Dr. May Nwe Lwin, a clinical research fellow within Dr. Edwards’ group.
Dr. Lwin presented data on 83 patients who had received baricitinib at University Hospital Southampton between October 2017 and July 2020, 55 (65.2%) of whom remain on treatment to date, with mean follow-up of 17 months. Of the 28 patients who stopped baricitinib, 21 stopped within 12 months.
“Patients who continued on baricitinib appeared more likely to be older and female,” Dr. Lwin said.
The mean age of patients who continued on treatment after 12 months was 61.5 years but was 49 years for those who stopped earlier. The percentage of women continuing treatment at 12 months versus those stopping earlier were a respective 82% and 67%. Both findings were significant (P < .001) but “could mean nothing, or could be very interesting data to explore more,” Dr. Lwin suggested.
“However, there was no significant difference in discontinuation rates for those using mono or combination therapy, and also no effect of disease duration or seropositivity,” Dr. Lwin said.
“Most people stopped baricitinib in the first 3 months of their treatment,” Dr. Lwin reported, noting that the most common reason was a lack of efficacy in 64% of patients, with 28.5% of patients discontinuing because of side effects.
“When you look at the adverse events, the reasons for discontinuation are quite variable,” Dr. Lwin said. These included infections (one urinary tract infection, two chest infections, and a urinary tract infection), and one case each of discitis, deranged liver function, lymphoma, and personality change.
Update on the long-term safety profile
Also at the BSR annual conference, an update on the long-term safety profile of baricitinib seen in clinical trials was presented, using data from the ‘All-BARI-RA’ dataset. This includes data from nine clinical trials and one long-term extension study.
“We recently published a long-term safety analysis of this molecule involving 3,700-plus patients with exposure up to 7 years,” said Kevin L. Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health Sciences University in Portland.
Dr. Winthrop provided an update on this, adding in another 13,148 patient-years of follow-up and giving data on the safety experience with baricitinib with up to 8.4 years of exposure for some patients.
“In short, not much has changed,” Dr. Winthrop said, noting that event rates have remained stable.
The overall major adverse cardiovascular event (MACE) and overall deep vein thrombosis/pulmonary embolism event rate were both 0.5 per 100 patient-years. Referring to the latter, Dr. Winthrop called them “rock solid stable” and “it’s been that way really all the way through the development program.”
Overall, event rates per 100 patient-years for serious infections, herpes zoster, and tuberculosis were a respective 2.7, 3.0, and 0.2. Serious infection rates over time have remained similar, but “clearly age is a risk factor for infection,” Dr. Winthrop said. “I would just say it’s similar to what we see with all biologics and small molecules in this setting.”
Malignancy and death rates were also higher in older patients, but after age adjustment, these had been stable across the different analysis points.
“Malignancy overall, excluding NMSC [nonmelanoma skin cancer], the event rate is 0.9 per 100 patient-years, very similar to what we’ve seen in the prior data cuts,” he said. “The same is true for lymphoma,” he added, with an overall event rate of 0.1 per 100 patient-years.
This updated analysis, Dr. Winthrop concluded, “suggests a safety profile really very similar to what was published recently.”Dr. Edwards has received research and educational grants and advisory panel and speaker fees from Eli Lilly and from multiple other pharmaceutical companies. The analysis of BSRBR-RA data he presented was sponsored by Eli Lilly and performed independently of the BSRBR-RA study team. Dr. Packham reported no conflicts of interest; he chaired the oral abstracts sessions in which Dr. Edwards presented his findings.
Dr. Lwin did not report having any disclosures.
Dr. Winthrop has acted as a consultant to Eli Lilly and several other pharmaceutical companies and had received research or grant support from Bristol-Myers Squibb and Pfizer. The work he presented was sponsored by Eli Lilly.
FROM BSR 2021
A new biomarker of traumatic brain injury?
, new research suggests. “Reliable detection of this biomarker at very early time points may allow for prompt TBI detection and therefore intervention,” said study investigator Rachel Elizabeth Thomas, MD, PhD, a neurology resident at the University of Pennsylvania, Philadelphia, while presenting study findings at the American Academy of Neurology’s 2021 annual meeting.
“The level reflects the degree of severity and provides some degree of prognostic information,” she added.
A specific marker of acute injury?
Von Willebrand factor is a glycoprotein released in the endothelium in response to local trauma. It plays a part in hemostasis and inflammation and is an indicator of traumatic microvascular injury. Research has shown that it is a biomarker of cerebrovascular pathology. In addition, increased expression of the factor is associated with vascular and neurodegenerative dementia.
The researchers examined whether von Willebrand factor is a biomarker of mild, repetitive TBI. They measured plasma levels of von Willebrand factor in 17 professional boxers before and after boxing bouts.
Eligible participants were between the ages of 18 and 35 years. They had a score of greater than or equal to 1 on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ-3), had competed in at least three 3-minute bouts, and had withstood 25 or more blows to the head.
The investigators compared the plasma levels of von Willebrand factor of the boxers with those of 42 patients who presented to the University of Pennsylvania Trauma Center with TBI and with those of 23 uninjured control persons.
There was no significant difference in plasma levels of von Willebrand factor between boxers before the bout (13.15 µg/mL) and the control persons (6.16 µg/mL). Among the boxers, levels of von Willebrand factor increased by a factor of 1.8 within 30 minutes after bouts, compared with the levels among the control persons. The mean post-bout von Willebrand factor level was 25.09 µg/mL.
“Von Willebrand factor may be more specific for acute injuries, given that it does not seem to stay chronically elevated,” said Dr. Thomas.
In addition, the researchers found a significant positive correlation (r = 0.51; P = .03) between the fold change in plasma von Willebrand factor levels and the number of blows to the head that the athletes sustained.
They also found a significant positive correlation between fold change in von Willebrand factor and RPQ-3 score (r = 0.69; P = .002). These objective and subjective data suggest that levels of von Willebrand factor reflect injury severity, said Dr. Thomas.
Among patients hospitalized with TBI, levels of von Willebrand factor were significantly higher than among control persons (73.2 µg/mL vs. 40.8 µg/mL; P < .0009). The investigators found a linear correlation between plasma von Willebrand factor level and RPQ-3 score (r = 0.24) that was not statistically significant.
Levels of von Willebrand factor among patients hospitalized with TBI were higher on average and demonstrated a greater degree of variability than the levels among boxers immediately after a bout.
“This is not unexpected, given that this group represents a more heterogeneous population with varied forms of acute blunt injury, as compared to the boxers, who have undergone relatively repetitive, milder trauma,” Dr. Thomas said.
The traditional biomarkers of neurotrauma reflect neuronal and glial injury, whereas von Willebrand factor is an indicator of vascular trauma.
“Although on its own, von Willebrand factor is not specific to intracranial vascular injury, paired together with markers such as neurofilament light, GFAP [glial fibrillary acidic protein], and tau, it could be utilized to identify TBI-associated microvascular injury and thus delineate between specific TBI endophenotypes,” said Dr. Thomas. It could distinguish, for example, predominantly neuronal injury from predominantly vascular injury.
Because von Willebrand factor plays a role in the neurovascular unit and is a marker of microvascular injury, the investigators intend to pair measurements of plasma von Willebrand factor with advanced imaging techniques to evaluate cerebral blood flow or cerebrovascular reactivity. Such a study could help determine whether von Willebrand factor levels correlate with the degree of vascular injury and cerebrovascular dysregulation.
Point-of-care test?
Commenting on the findings, Kristine O’Phelan, MD, professor of clinical neurology and director of neurocritical care in the department of neurology at the University of Miami, said von Willebrand factor’s likely utility would be as a marker of injury in patients with mild TBI or sports-related concussion.
Imaging and clinical exams do not always reveal these injuries, Dr. O’Phelan added. “Having a biomarker that you can easily test in the blood would be extremely helpful,” she said.
The most exciting part of this study is that it indicates the potential to develop a point-of-care test for use on the athletic field or the battlefield for early detection of mild TBI, she added.
The fact that the test for von Willebrand factor has already been developed is an advantage, said Dr. O’Phelan. The normal and abnormal values of the test are clearly understood. “I do think that they will still need to calibrate it for head injury, because that’s not usually what the test is used for,” said Dr. O’Phelan.
One of the study’s strengths is that the investigators compared patients with TBI with control persons who had exercised, she added, because such a comparison helps clarify the biomarker’s relationship to the injury. Another strength is the application of the test to injuries of various types and of different degrees of severity.
But the biomarker will need to be tested in a larger population, said Dr. O’Phelan. In addition, there is a need to identify the right patient population for this test, as well as the best time frame for its application and potential factors that could confound the test results.
“I do worry a little bit about using early biomarkers for prognosis, particularly in severe TBI, because there’s so many variables that go into outcome,” said Dr. O’Phelan. This test likely would be administered in the first hours after injury, but many factors might affect patients’ outcomes, she added.
One influential factor is age. “If you have a von Willebrand factor of whatever number, that might have different importance in a 30-year-old than in an 80-year-old,” said Dr. O’Phelan. “We need to understand how to interpret those findings better.”
The study was supported by the National Institute for Neurological Disorders and Stroke, the U.S. Department of Defense, and the Pennsylvania Department of Health. Dr. Thomas and Dr. O’Phelan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests. “Reliable detection of this biomarker at very early time points may allow for prompt TBI detection and therefore intervention,” said study investigator Rachel Elizabeth Thomas, MD, PhD, a neurology resident at the University of Pennsylvania, Philadelphia, while presenting study findings at the American Academy of Neurology’s 2021 annual meeting.
“The level reflects the degree of severity and provides some degree of prognostic information,” she added.
A specific marker of acute injury?
Von Willebrand factor is a glycoprotein released in the endothelium in response to local trauma. It plays a part in hemostasis and inflammation and is an indicator of traumatic microvascular injury. Research has shown that it is a biomarker of cerebrovascular pathology. In addition, increased expression of the factor is associated with vascular and neurodegenerative dementia.
The researchers examined whether von Willebrand factor is a biomarker of mild, repetitive TBI. They measured plasma levels of von Willebrand factor in 17 professional boxers before and after boxing bouts.
Eligible participants were between the ages of 18 and 35 years. They had a score of greater than or equal to 1 on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ-3), had competed in at least three 3-minute bouts, and had withstood 25 or more blows to the head.
The investigators compared the plasma levels of von Willebrand factor of the boxers with those of 42 patients who presented to the University of Pennsylvania Trauma Center with TBI and with those of 23 uninjured control persons.
There was no significant difference in plasma levels of von Willebrand factor between boxers before the bout (13.15 µg/mL) and the control persons (6.16 µg/mL). Among the boxers, levels of von Willebrand factor increased by a factor of 1.8 within 30 minutes after bouts, compared with the levels among the control persons. The mean post-bout von Willebrand factor level was 25.09 µg/mL.
“Von Willebrand factor may be more specific for acute injuries, given that it does not seem to stay chronically elevated,” said Dr. Thomas.
In addition, the researchers found a significant positive correlation (r = 0.51; P = .03) between the fold change in plasma von Willebrand factor levels and the number of blows to the head that the athletes sustained.
They also found a significant positive correlation between fold change in von Willebrand factor and RPQ-3 score (r = 0.69; P = .002). These objective and subjective data suggest that levels of von Willebrand factor reflect injury severity, said Dr. Thomas.
Among patients hospitalized with TBI, levels of von Willebrand factor were significantly higher than among control persons (73.2 µg/mL vs. 40.8 µg/mL; P < .0009). The investigators found a linear correlation between plasma von Willebrand factor level and RPQ-3 score (r = 0.24) that was not statistically significant.
Levels of von Willebrand factor among patients hospitalized with TBI were higher on average and demonstrated a greater degree of variability than the levels among boxers immediately after a bout.
“This is not unexpected, given that this group represents a more heterogeneous population with varied forms of acute blunt injury, as compared to the boxers, who have undergone relatively repetitive, milder trauma,” Dr. Thomas said.
The traditional biomarkers of neurotrauma reflect neuronal and glial injury, whereas von Willebrand factor is an indicator of vascular trauma.
“Although on its own, von Willebrand factor is not specific to intracranial vascular injury, paired together with markers such as neurofilament light, GFAP [glial fibrillary acidic protein], and tau, it could be utilized to identify TBI-associated microvascular injury and thus delineate between specific TBI endophenotypes,” said Dr. Thomas. It could distinguish, for example, predominantly neuronal injury from predominantly vascular injury.
Because von Willebrand factor plays a role in the neurovascular unit and is a marker of microvascular injury, the investigators intend to pair measurements of plasma von Willebrand factor with advanced imaging techniques to evaluate cerebral blood flow or cerebrovascular reactivity. Such a study could help determine whether von Willebrand factor levels correlate with the degree of vascular injury and cerebrovascular dysregulation.
Point-of-care test?
Commenting on the findings, Kristine O’Phelan, MD, professor of clinical neurology and director of neurocritical care in the department of neurology at the University of Miami, said von Willebrand factor’s likely utility would be as a marker of injury in patients with mild TBI or sports-related concussion.
Imaging and clinical exams do not always reveal these injuries, Dr. O’Phelan added. “Having a biomarker that you can easily test in the blood would be extremely helpful,” she said.
The most exciting part of this study is that it indicates the potential to develop a point-of-care test for use on the athletic field or the battlefield for early detection of mild TBI, she added.
The fact that the test for von Willebrand factor has already been developed is an advantage, said Dr. O’Phelan. The normal and abnormal values of the test are clearly understood. “I do think that they will still need to calibrate it for head injury, because that’s not usually what the test is used for,” said Dr. O’Phelan.
One of the study’s strengths is that the investigators compared patients with TBI with control persons who had exercised, she added, because such a comparison helps clarify the biomarker’s relationship to the injury. Another strength is the application of the test to injuries of various types and of different degrees of severity.
But the biomarker will need to be tested in a larger population, said Dr. O’Phelan. In addition, there is a need to identify the right patient population for this test, as well as the best time frame for its application and potential factors that could confound the test results.
“I do worry a little bit about using early biomarkers for prognosis, particularly in severe TBI, because there’s so many variables that go into outcome,” said Dr. O’Phelan. This test likely would be administered in the first hours after injury, but many factors might affect patients’ outcomes, she added.
One influential factor is age. “If you have a von Willebrand factor of whatever number, that might have different importance in a 30-year-old than in an 80-year-old,” said Dr. O’Phelan. “We need to understand how to interpret those findings better.”
The study was supported by the National Institute for Neurological Disorders and Stroke, the U.S. Department of Defense, and the Pennsylvania Department of Health. Dr. Thomas and Dr. O’Phelan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests. “Reliable detection of this biomarker at very early time points may allow for prompt TBI detection and therefore intervention,” said study investigator Rachel Elizabeth Thomas, MD, PhD, a neurology resident at the University of Pennsylvania, Philadelphia, while presenting study findings at the American Academy of Neurology’s 2021 annual meeting.
“The level reflects the degree of severity and provides some degree of prognostic information,” she added.
A specific marker of acute injury?
Von Willebrand factor is a glycoprotein released in the endothelium in response to local trauma. It plays a part in hemostasis and inflammation and is an indicator of traumatic microvascular injury. Research has shown that it is a biomarker of cerebrovascular pathology. In addition, increased expression of the factor is associated with vascular and neurodegenerative dementia.
The researchers examined whether von Willebrand factor is a biomarker of mild, repetitive TBI. They measured plasma levels of von Willebrand factor in 17 professional boxers before and after boxing bouts.
Eligible participants were between the ages of 18 and 35 years. They had a score of greater than or equal to 1 on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ-3), had competed in at least three 3-minute bouts, and had withstood 25 or more blows to the head.
The investigators compared the plasma levels of von Willebrand factor of the boxers with those of 42 patients who presented to the University of Pennsylvania Trauma Center with TBI and with those of 23 uninjured control persons.
There was no significant difference in plasma levels of von Willebrand factor between boxers before the bout (13.15 µg/mL) and the control persons (6.16 µg/mL). Among the boxers, levels of von Willebrand factor increased by a factor of 1.8 within 30 minutes after bouts, compared with the levels among the control persons. The mean post-bout von Willebrand factor level was 25.09 µg/mL.
“Von Willebrand factor may be more specific for acute injuries, given that it does not seem to stay chronically elevated,” said Dr. Thomas.
In addition, the researchers found a significant positive correlation (r = 0.51; P = .03) between the fold change in plasma von Willebrand factor levels and the number of blows to the head that the athletes sustained.
They also found a significant positive correlation between fold change in von Willebrand factor and RPQ-3 score (r = 0.69; P = .002). These objective and subjective data suggest that levels of von Willebrand factor reflect injury severity, said Dr. Thomas.
Among patients hospitalized with TBI, levels of von Willebrand factor were significantly higher than among control persons (73.2 µg/mL vs. 40.8 µg/mL; P < .0009). The investigators found a linear correlation between plasma von Willebrand factor level and RPQ-3 score (r = 0.24) that was not statistically significant.
Levels of von Willebrand factor among patients hospitalized with TBI were higher on average and demonstrated a greater degree of variability than the levels among boxers immediately after a bout.
“This is not unexpected, given that this group represents a more heterogeneous population with varied forms of acute blunt injury, as compared to the boxers, who have undergone relatively repetitive, milder trauma,” Dr. Thomas said.
The traditional biomarkers of neurotrauma reflect neuronal and glial injury, whereas von Willebrand factor is an indicator of vascular trauma.
“Although on its own, von Willebrand factor is not specific to intracranial vascular injury, paired together with markers such as neurofilament light, GFAP [glial fibrillary acidic protein], and tau, it could be utilized to identify TBI-associated microvascular injury and thus delineate between specific TBI endophenotypes,” said Dr. Thomas. It could distinguish, for example, predominantly neuronal injury from predominantly vascular injury.
Because von Willebrand factor plays a role in the neurovascular unit and is a marker of microvascular injury, the investigators intend to pair measurements of plasma von Willebrand factor with advanced imaging techniques to evaluate cerebral blood flow or cerebrovascular reactivity. Such a study could help determine whether von Willebrand factor levels correlate with the degree of vascular injury and cerebrovascular dysregulation.
Point-of-care test?
Commenting on the findings, Kristine O’Phelan, MD, professor of clinical neurology and director of neurocritical care in the department of neurology at the University of Miami, said von Willebrand factor’s likely utility would be as a marker of injury in patients with mild TBI or sports-related concussion.
Imaging and clinical exams do not always reveal these injuries, Dr. O’Phelan added. “Having a biomarker that you can easily test in the blood would be extremely helpful,” she said.
The most exciting part of this study is that it indicates the potential to develop a point-of-care test for use on the athletic field or the battlefield for early detection of mild TBI, she added.
The fact that the test for von Willebrand factor has already been developed is an advantage, said Dr. O’Phelan. The normal and abnormal values of the test are clearly understood. “I do think that they will still need to calibrate it for head injury, because that’s not usually what the test is used for,” said Dr. O’Phelan.
One of the study’s strengths is that the investigators compared patients with TBI with control persons who had exercised, she added, because such a comparison helps clarify the biomarker’s relationship to the injury. Another strength is the application of the test to injuries of various types and of different degrees of severity.
But the biomarker will need to be tested in a larger population, said Dr. O’Phelan. In addition, there is a need to identify the right patient population for this test, as well as the best time frame for its application and potential factors that could confound the test results.
“I do worry a little bit about using early biomarkers for prognosis, particularly in severe TBI, because there’s so many variables that go into outcome,” said Dr. O’Phelan. This test likely would be administered in the first hours after injury, but many factors might affect patients’ outcomes, she added.
One influential factor is age. “If you have a von Willebrand factor of whatever number, that might have different importance in a 30-year-old than in an 80-year-old,” said Dr. O’Phelan. “We need to understand how to interpret those findings better.”
The study was supported by the National Institute for Neurological Disorders and Stroke, the U.S. Department of Defense, and the Pennsylvania Department of Health. Dr. Thomas and Dr. O’Phelan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
From AAN 2021
Nighttime asthma predicts poor outcomes in teens
Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.
Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.
In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.
The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.
Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.
Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).
In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).
The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.
The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.
However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.
“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.
However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.
“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.
Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.
However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.
The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.
*This story was updated on May 5. 2021.
Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.
Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.
In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.
The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.
Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.
Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).
In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).
The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.
The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.
However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.
“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.
However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.
“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.
Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.
However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.
The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.
*This story was updated on May 5. 2021.
Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.
Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.
In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.
The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.
Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.
Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).
In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).
The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.
The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.
However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.
“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.
However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.
“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.
Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.
However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.
The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.
*This story was updated on May 5. 2021.
FROM PAS 2021
Police contact tied to elevated anxiety in young Black adults
Young Black adults who witness or experience police violence have significantly elevated levels of anxiety, new research shows.
In the first study to quantify the impact of police contact anxiety, investigators found it was associated with moderately severe anxiety levels in this group of individuals, highlighting the need to screen for exposure to police violence in this patient population, study investigator Robert O. Motley Jr, PhD, manager of the Race & Opportunity Lab at Washington University in St. Louis, said in an interview.
“If you’re working in an institution and providing clinical care, mental health care, or behavior health care, these additional measures should be included to get a much more holistic view of the exposure of these individuals in terms of traumatic events. These assessments can inform your decisions around care,” Dr. Motley added.
The findings were presented at the annual meeting of the American Psychiatric Association.
‘Alarming’ rates of exposure
Evidence shows anxiety disorders are among the most prevalent conditions for Black people aged 18-29 years – an age group described as “emergent adulthood” because these individuals haven’t yet taken on full responsibilities of adulthood.
Research shows Black emergent adults are three to four times more likely than other ethnic groups to be exposed to actual or threatened nonfatal police violence, said Dr. Motley. “So they didn’t die, but were exposed to force, which could be things like police yelling at them, hitting or kicking them, pointing a gun at them, or tasing them.”
These individuals are also two to three times more likely to experience exposure to fatal police violence, and to be unarmed and killed, said Dr. Motley.
Evidence shows a clear link between exposure to stressful or traumatic events and anxiety disorders, but there has been little research examining the relationship between exposure to police violence and anxiety disorders among Black emergent adults, he said.
To assess the prevalence and correlates of “police contact anxiety” the investigators used computer-assisted surveys to collect data from 300 young Black college students in St. Louis who had been exposed to police violence at some point in their lives. The mean age of the sample was 20.4 years and included an equal number of men and women.
Work status for the previous year showed almost one-quarter (23.6%) were unemployed and about half worked part time. Almost two-thirds (62.6%) had an annual income of less than $10,000.
Respondents reported they had personally experienced police violence almost twice (a mean of 1.89) during their lifetime. The mean number of times they witnessed police using force against someone else was 7.82. Respondents also reported they had watched videos showing police use of force on the internet or television an average of 34.5 times.
This, said Dr. Motley, isn’t surprising given the growing number of young adults – of all races – who are using social media platforms to upload and share videos.
The researchers also looked at witnessing community violence, unrelated to police violence. Here, respondents had an average of 10.9 exposures.
Protectors or predators?
To examine the impact of police contact anxiety caused either by direct experience, or as a result of witnessing, or seeing a video of police use of violence in the past 30 days, the researchers created a “police contact anxiety” scale.
Respondents were asked six questions pertaining specifically to experiences during, or in anticipation of, police contact and its effects on anxiety levels.
For each of the six questions, participants rated the severity of anxiety on a scale of 0 (least severe) to 3 (most severe) for each exposure type. The final score had a potential range of 0-24.
Results showed police contact anxiety was moderately severe for all three exposure types with scores ranging from 13 to 14.
Ordinary least square regression analyses showed that, compared with unemployed participants, those who worked full time were less likely to have higher police contact anxiety as a result of seeing a video of police use of force (P < .05) – a finding Dr. Motley said was not surprising.
Employment, he noted, promotes individual self-efficacy, social participation, and mental health, which may provide a “buffer” to the effects of watching videos of police violence.
Dr. Motley noted that police officers “have been entrusted to serve and protect” the community, but “rarely face consequences when they use force against Black emergent adults; they’re rarely held accountable.”
These young Black adults “may perceive police officers as more of a threat to personal safety instead of a protector of it.”
Additional bivariate analyses showed that males had significantly higher scores than females for police contact anxiety because of witnessing police use of force.
This, too, was not surprising since males are exposed to more violence in general, said Dr. Motley.
It’s important to replicate the findings using a much larger and more diverse sample, he said. His next research project will be to collect data from a nationally representative sample of emerging adults across different ethnic groups and examining a range of different variables.
Commenting on the findings, Jeffrey Borenstein, MD, president and CEO of the Brain & Behavior Research Foundation and editor in chief of Psychiatric News, called it “outstanding.”
“This is a very important issue,” said Dr. Borenstein, who moderated a press briefing that featured the study.
“We know anxiety is an extremely important condition and symptom, across the board for all groups, and often anxiety isn’t evaluated in the way that it needs to be. This is a great study that will lead to further research in this important area,” he added.
The study was funded by the National Institute on Minority Health and Health Disparities. Dr. Motley and Dr. Borenstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Young Black adults who witness or experience police violence have significantly elevated levels of anxiety, new research shows.
In the first study to quantify the impact of police contact anxiety, investigators found it was associated with moderately severe anxiety levels in this group of individuals, highlighting the need to screen for exposure to police violence in this patient population, study investigator Robert O. Motley Jr, PhD, manager of the Race & Opportunity Lab at Washington University in St. Louis, said in an interview.
“If you’re working in an institution and providing clinical care, mental health care, or behavior health care, these additional measures should be included to get a much more holistic view of the exposure of these individuals in terms of traumatic events. These assessments can inform your decisions around care,” Dr. Motley added.
The findings were presented at the annual meeting of the American Psychiatric Association.
‘Alarming’ rates of exposure
Evidence shows anxiety disorders are among the most prevalent conditions for Black people aged 18-29 years – an age group described as “emergent adulthood” because these individuals haven’t yet taken on full responsibilities of adulthood.
Research shows Black emergent adults are three to four times more likely than other ethnic groups to be exposed to actual or threatened nonfatal police violence, said Dr. Motley. “So they didn’t die, but were exposed to force, which could be things like police yelling at them, hitting or kicking them, pointing a gun at them, or tasing them.”
These individuals are also two to three times more likely to experience exposure to fatal police violence, and to be unarmed and killed, said Dr. Motley.
Evidence shows a clear link between exposure to stressful or traumatic events and anxiety disorders, but there has been little research examining the relationship between exposure to police violence and anxiety disorders among Black emergent adults, he said.
To assess the prevalence and correlates of “police contact anxiety” the investigators used computer-assisted surveys to collect data from 300 young Black college students in St. Louis who had been exposed to police violence at some point in their lives. The mean age of the sample was 20.4 years and included an equal number of men and women.
Work status for the previous year showed almost one-quarter (23.6%) were unemployed and about half worked part time. Almost two-thirds (62.6%) had an annual income of less than $10,000.
Respondents reported they had personally experienced police violence almost twice (a mean of 1.89) during their lifetime. The mean number of times they witnessed police using force against someone else was 7.82. Respondents also reported they had watched videos showing police use of force on the internet or television an average of 34.5 times.
This, said Dr. Motley, isn’t surprising given the growing number of young adults – of all races – who are using social media platforms to upload and share videos.
The researchers also looked at witnessing community violence, unrelated to police violence. Here, respondents had an average of 10.9 exposures.
Protectors or predators?
To examine the impact of police contact anxiety caused either by direct experience, or as a result of witnessing, or seeing a video of police use of violence in the past 30 days, the researchers created a “police contact anxiety” scale.
Respondents were asked six questions pertaining specifically to experiences during, or in anticipation of, police contact and its effects on anxiety levels.
For each of the six questions, participants rated the severity of anxiety on a scale of 0 (least severe) to 3 (most severe) for each exposure type. The final score had a potential range of 0-24.
Results showed police contact anxiety was moderately severe for all three exposure types with scores ranging from 13 to 14.
Ordinary least square regression analyses showed that, compared with unemployed participants, those who worked full time were less likely to have higher police contact anxiety as a result of seeing a video of police use of force (P < .05) – a finding Dr. Motley said was not surprising.
Employment, he noted, promotes individual self-efficacy, social participation, and mental health, which may provide a “buffer” to the effects of watching videos of police violence.
Dr. Motley noted that police officers “have been entrusted to serve and protect” the community, but “rarely face consequences when they use force against Black emergent adults; they’re rarely held accountable.”
These young Black adults “may perceive police officers as more of a threat to personal safety instead of a protector of it.”
Additional bivariate analyses showed that males had significantly higher scores than females for police contact anxiety because of witnessing police use of force.
This, too, was not surprising since males are exposed to more violence in general, said Dr. Motley.
It’s important to replicate the findings using a much larger and more diverse sample, he said. His next research project will be to collect data from a nationally representative sample of emerging adults across different ethnic groups and examining a range of different variables.
Commenting on the findings, Jeffrey Borenstein, MD, president and CEO of the Brain & Behavior Research Foundation and editor in chief of Psychiatric News, called it “outstanding.”
“This is a very important issue,” said Dr. Borenstein, who moderated a press briefing that featured the study.
“We know anxiety is an extremely important condition and symptom, across the board for all groups, and often anxiety isn’t evaluated in the way that it needs to be. This is a great study that will lead to further research in this important area,” he added.
The study was funded by the National Institute on Minority Health and Health Disparities. Dr. Motley and Dr. Borenstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Young Black adults who witness or experience police violence have significantly elevated levels of anxiety, new research shows.
In the first study to quantify the impact of police contact anxiety, investigators found it was associated with moderately severe anxiety levels in this group of individuals, highlighting the need to screen for exposure to police violence in this patient population, study investigator Robert O. Motley Jr, PhD, manager of the Race & Opportunity Lab at Washington University in St. Louis, said in an interview.
“If you’re working in an institution and providing clinical care, mental health care, or behavior health care, these additional measures should be included to get a much more holistic view of the exposure of these individuals in terms of traumatic events. These assessments can inform your decisions around care,” Dr. Motley added.
The findings were presented at the annual meeting of the American Psychiatric Association.
‘Alarming’ rates of exposure
Evidence shows anxiety disorders are among the most prevalent conditions for Black people aged 18-29 years – an age group described as “emergent adulthood” because these individuals haven’t yet taken on full responsibilities of adulthood.
Research shows Black emergent adults are three to four times more likely than other ethnic groups to be exposed to actual or threatened nonfatal police violence, said Dr. Motley. “So they didn’t die, but were exposed to force, which could be things like police yelling at them, hitting or kicking them, pointing a gun at them, or tasing them.”
These individuals are also two to three times more likely to experience exposure to fatal police violence, and to be unarmed and killed, said Dr. Motley.
Evidence shows a clear link between exposure to stressful or traumatic events and anxiety disorders, but there has been little research examining the relationship between exposure to police violence and anxiety disorders among Black emergent adults, he said.
To assess the prevalence and correlates of “police contact anxiety” the investigators used computer-assisted surveys to collect data from 300 young Black college students in St. Louis who had been exposed to police violence at some point in their lives. The mean age of the sample was 20.4 years and included an equal number of men and women.
Work status for the previous year showed almost one-quarter (23.6%) were unemployed and about half worked part time. Almost two-thirds (62.6%) had an annual income of less than $10,000.
Respondents reported they had personally experienced police violence almost twice (a mean of 1.89) during their lifetime. The mean number of times they witnessed police using force against someone else was 7.82. Respondents also reported they had watched videos showing police use of force on the internet or television an average of 34.5 times.
This, said Dr. Motley, isn’t surprising given the growing number of young adults – of all races – who are using social media platforms to upload and share videos.
The researchers also looked at witnessing community violence, unrelated to police violence. Here, respondents had an average of 10.9 exposures.
Protectors or predators?
To examine the impact of police contact anxiety caused either by direct experience, or as a result of witnessing, or seeing a video of police use of violence in the past 30 days, the researchers created a “police contact anxiety” scale.
Respondents were asked six questions pertaining specifically to experiences during, or in anticipation of, police contact and its effects on anxiety levels.
For each of the six questions, participants rated the severity of anxiety on a scale of 0 (least severe) to 3 (most severe) for each exposure type. The final score had a potential range of 0-24.
Results showed police contact anxiety was moderately severe for all three exposure types with scores ranging from 13 to 14.
Ordinary least square regression analyses showed that, compared with unemployed participants, those who worked full time were less likely to have higher police contact anxiety as a result of seeing a video of police use of force (P < .05) – a finding Dr. Motley said was not surprising.
Employment, he noted, promotes individual self-efficacy, social participation, and mental health, which may provide a “buffer” to the effects of watching videos of police violence.
Dr. Motley noted that police officers “have been entrusted to serve and protect” the community, but “rarely face consequences when they use force against Black emergent adults; they’re rarely held accountable.”
These young Black adults “may perceive police officers as more of a threat to personal safety instead of a protector of it.”
Additional bivariate analyses showed that males had significantly higher scores than females for police contact anxiety because of witnessing police use of force.
This, too, was not surprising since males are exposed to more violence in general, said Dr. Motley.
It’s important to replicate the findings using a much larger and more diverse sample, he said. His next research project will be to collect data from a nationally representative sample of emerging adults across different ethnic groups and examining a range of different variables.
Commenting on the findings, Jeffrey Borenstein, MD, president and CEO of the Brain & Behavior Research Foundation and editor in chief of Psychiatric News, called it “outstanding.”
“This is a very important issue,” said Dr. Borenstein, who moderated a press briefing that featured the study.
“We know anxiety is an extremely important condition and symptom, across the board for all groups, and often anxiety isn’t evaluated in the way that it needs to be. This is a great study that will lead to further research in this important area,” he added.
The study was funded by the National Institute on Minority Health and Health Disparities. Dr. Motley and Dr. Borenstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patchy growth of TAVR programs leaves poorer communities behind
Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.
Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.
Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.
Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.
Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).
When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).
“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.
Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.
Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.
As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”
Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”
Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.
“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.
“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”
Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.
“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”
Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.
A version of this article first appeared on Medscape.com.
Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.
Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.
Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.
Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.
Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).
When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).
“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.
Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.
Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.
As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”
Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”
Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.
“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.
“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”
Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.
“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”
Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.
A version of this article first appeared on Medscape.com.
Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.
Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.
Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.
Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.
Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).
When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).
“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.
Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.
Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.
As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”
Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”
Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.
“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.
“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”
Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.
“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”
Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.
A version of this article first appeared on Medscape.com.
The power and promise of social media in oncology
Mark A. Lewis, MD, explained to the COSMO meeting audience how storytelling on social media can educate and engage patients, advocates, and professional colleagues – advancing knowledge, dispelling misinformation, and promoting clinical research.
Dr. Lewis, an oncologist at Intermountain Healthcare in Salt Lake City, reflected on the bifid roles of oncologists as scientists engaged in life-long learning and humanists who can internalize and appreciate the unique character and circumstances of their patients.
Patients who have serious illnesses are necessarily aggregated by statistics. However, in an essay published in 2011, Dr. Lewis noted that “each individual patient partakes in a unique, irreproducible experiment where n = 1” (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).
Dr. Lewis highlighted the duality of individual data points on a survival curve as descriptors of common disease trajectories and treatment effects. However, those data points also conceal important narratives regarding the most highly valued aspects of the doctor-patient relationship and the impact of cancer treatment on patients’ lives.
In referring to the futuristic essay “Ars Brevis,” Dr. Lewis contrasted the humanism of oncology specialists in the present day with the fictional image of data-regurgitating robots programmed to maximize the efficiency of each patient encounter (J Clin Oncol. 2013 May 10;31[14]:1792-4).
Dr. Lewis reminded attendees that to practice medicine without using both “head and heart” undermines the inherent nature of medical care.
Unfortunately, that perspective may not match the public perception of oncologists. Dr. Lewis described his experience of typing “oncologists are” into an Internet search engine and seeing the auto-complete function prompt words such as “criminals,” “evil,” “murderers,” and “confused.”
Obviously, it is hard to establish a trusting patient-doctor relationship if that is the prima facie perception of the oncology specialty.
Dispelling myths and creating community via social media
A primary goal of consultation with a newly-diagnosed cancer patient is for the patient to feel that the oncologist will be there to take care of them, regardless of what the future holds.
Dr. Lewis has found that social media can potentially extend that feeling to a global community of patients, caregivers, and others seeking information relevant to a cancer diagnosis. He believes that oncologists have an opportunity to dispel myths and fears by being attentive to the real-life concerns of patients.
Dr. Lewis took advantage of this opportunity when he underwent a Whipple procedure (pancreaticoduodenectomy) for a pancreatic neuroendocrine tumor. He and the hospital’s media services staff “live-tweeted” his surgery and recovery.
With those tweets, Dr. Lewis demystified each step of a major surgical procedure. From messages he received on social media, Dr. Lewis knows he made the decision to have a Whipple procedure more acceptable to other patients.
His personal medical experience notwithstanding, Dr. Lewis acknowledged that every patient’s circumstances are unique.
Oncologists cannot possibly empathize with every circumstance. However, when they show sensitivity to personal elements of the cancer experience, they shed light on the complicated role they play in patient care and can facilitate good decision-making among patients across the globe.
Social media for professional development and patient care
The publication of his 2011 essay was gratifying for Dr. Lewis, but the finite number of comments he received thereafter illustrated the rather limited audience that traditional academic publications have and the laborious process for subsequent interaction (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).
First as an observer and later as a participant on social media, Dr. Lewis appreciated that teaching points and publications can be amplified by global distribution and the potential for informal bidirectional communication.
Social media platforms enable physicians to connect with a larger audience through participative communication, in which users develop, share, and react to content (N Engl J Med. 2009 Aug 13;361[7]:649-51).
Dr. Lewis reflected on how oncologists are challenged to sort through the thousands of oncology-focused publications annually. Through social media, one can see the studies on which the experts are commenting and appreciate the nuances that contextualize the results. Focused interactions with renowned doctors, at regular intervals, require little formality.
Online journal clubs enable the sharing of ideas, opinions, multimedia resources, and references across institutional and international borders (J Gen Intern Med. 2014 Oct;29[10]:1317-8).
Social media in oncology: Accomplishments and promise
The development of broadband Internet, wireless connectivity, and social media for peer-to-peer and general communication are among the major technological advances that have transformed medical communication.
As an organization, COSMO aims to describe, understand, and improve the use of social media to increase the penetration of evidence-based guidelines and research insights into clinical practice (Future Oncol. 2017 Jun;13[15]:1281-5).
At the inaugural COSMO meeting, areas of progress since COSMO’s inception in 2015 were highlighted, including:
- The involvement of cancer professionals and advocates in multiple distinctive platforms.
- The development of hashtag libraries to aggregate interest groups and topics.
- The refinement of strategies for engaging advocates with attention to inclusiveness.
- A steady trajectory of growth in tweeting at scientific conferences.
An overarching theme of the COSMO meeting was “authenticity,” a virtue that is easy to admire but requires conscious, consistent effort to achieve.
Disclosure of conflicts of interest and avoiding using social media simply as a recruitment tool for clinical trials are basic components of accurate self-representation.
In addition, Dr. Lewis advocated for sharing personal experiences in a component of social media posts so oncologists can show humanity as a feature of their professional online identity and inherent nature.
Dr. Lewis disclosed consultancy with Medscape/WebMD, which are owned by the same parent company as MDedge. He also disclosed relationships with Foundation Medicine, Natera, Exelixis, QED, HalioDX, and Ipsen.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
Mark A. Lewis, MD, explained to the COSMO meeting audience how storytelling on social media can educate and engage patients, advocates, and professional colleagues – advancing knowledge, dispelling misinformation, and promoting clinical research.
Dr. Lewis, an oncologist at Intermountain Healthcare in Salt Lake City, reflected on the bifid roles of oncologists as scientists engaged in life-long learning and humanists who can internalize and appreciate the unique character and circumstances of their patients.
Patients who have serious illnesses are necessarily aggregated by statistics. However, in an essay published in 2011, Dr. Lewis noted that “each individual patient partakes in a unique, irreproducible experiment where n = 1” (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).
Dr. Lewis highlighted the duality of individual data points on a survival curve as descriptors of common disease trajectories and treatment effects. However, those data points also conceal important narratives regarding the most highly valued aspects of the doctor-patient relationship and the impact of cancer treatment on patients’ lives.
In referring to the futuristic essay “Ars Brevis,” Dr. Lewis contrasted the humanism of oncology specialists in the present day with the fictional image of data-regurgitating robots programmed to maximize the efficiency of each patient encounter (J Clin Oncol. 2013 May 10;31[14]:1792-4).
Dr. Lewis reminded attendees that to practice medicine without using both “head and heart” undermines the inherent nature of medical care.
Unfortunately, that perspective may not match the public perception of oncologists. Dr. Lewis described his experience of typing “oncologists are” into an Internet search engine and seeing the auto-complete function prompt words such as “criminals,” “evil,” “murderers,” and “confused.”
Obviously, it is hard to establish a trusting patient-doctor relationship if that is the prima facie perception of the oncology specialty.
Dispelling myths and creating community via social media
A primary goal of consultation with a newly-diagnosed cancer patient is for the patient to feel that the oncologist will be there to take care of them, regardless of what the future holds.
Dr. Lewis has found that social media can potentially extend that feeling to a global community of patients, caregivers, and others seeking information relevant to a cancer diagnosis. He believes that oncologists have an opportunity to dispel myths and fears by being attentive to the real-life concerns of patients.
Dr. Lewis took advantage of this opportunity when he underwent a Whipple procedure (pancreaticoduodenectomy) for a pancreatic neuroendocrine tumor. He and the hospital’s media services staff “live-tweeted” his surgery and recovery.
With those tweets, Dr. Lewis demystified each step of a major surgical procedure. From messages he received on social media, Dr. Lewis knows he made the decision to have a Whipple procedure more acceptable to other patients.
His personal medical experience notwithstanding, Dr. Lewis acknowledged that every patient’s circumstances are unique.
Oncologists cannot possibly empathize with every circumstance. However, when they show sensitivity to personal elements of the cancer experience, they shed light on the complicated role they play in patient care and can facilitate good decision-making among patients across the globe.
Social media for professional development and patient care
The publication of his 2011 essay was gratifying for Dr. Lewis, but the finite number of comments he received thereafter illustrated the rather limited audience that traditional academic publications have and the laborious process for subsequent interaction (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).
First as an observer and later as a participant on social media, Dr. Lewis appreciated that teaching points and publications can be amplified by global distribution and the potential for informal bidirectional communication.
Social media platforms enable physicians to connect with a larger audience through participative communication, in which users develop, share, and react to content (N Engl J Med. 2009 Aug 13;361[7]:649-51).
Dr. Lewis reflected on how oncologists are challenged to sort through the thousands of oncology-focused publications annually. Through social media, one can see the studies on which the experts are commenting and appreciate the nuances that contextualize the results. Focused interactions with renowned doctors, at regular intervals, require little formality.
Online journal clubs enable the sharing of ideas, opinions, multimedia resources, and references across institutional and international borders (J Gen Intern Med. 2014 Oct;29[10]:1317-8).
Social media in oncology: Accomplishments and promise
The development of broadband Internet, wireless connectivity, and social media for peer-to-peer and general communication are among the major technological advances that have transformed medical communication.
As an organization, COSMO aims to describe, understand, and improve the use of social media to increase the penetration of evidence-based guidelines and research insights into clinical practice (Future Oncol. 2017 Jun;13[15]:1281-5).
At the inaugural COSMO meeting, areas of progress since COSMO’s inception in 2015 were highlighted, including:
- The involvement of cancer professionals and advocates in multiple distinctive platforms.
- The development of hashtag libraries to aggregate interest groups and topics.
- The refinement of strategies for engaging advocates with attention to inclusiveness.
- A steady trajectory of growth in tweeting at scientific conferences.
An overarching theme of the COSMO meeting was “authenticity,” a virtue that is easy to admire but requires conscious, consistent effort to achieve.
Disclosure of conflicts of interest and avoiding using social media simply as a recruitment tool for clinical trials are basic components of accurate self-representation.
In addition, Dr. Lewis advocated for sharing personal experiences in a component of social media posts so oncologists can show humanity as a feature of their professional online identity and inherent nature.
Dr. Lewis disclosed consultancy with Medscape/WebMD, which are owned by the same parent company as MDedge. He also disclosed relationships with Foundation Medicine, Natera, Exelixis, QED, HalioDX, and Ipsen.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
Mark A. Lewis, MD, explained to the COSMO meeting audience how storytelling on social media can educate and engage patients, advocates, and professional colleagues – advancing knowledge, dispelling misinformation, and promoting clinical research.
Dr. Lewis, an oncologist at Intermountain Healthcare in Salt Lake City, reflected on the bifid roles of oncologists as scientists engaged in life-long learning and humanists who can internalize and appreciate the unique character and circumstances of their patients.
Patients who have serious illnesses are necessarily aggregated by statistics. However, in an essay published in 2011, Dr. Lewis noted that “each individual patient partakes in a unique, irreproducible experiment where n = 1” (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).
Dr. Lewis highlighted the duality of individual data points on a survival curve as descriptors of common disease trajectories and treatment effects. However, those data points also conceal important narratives regarding the most highly valued aspects of the doctor-patient relationship and the impact of cancer treatment on patients’ lives.
In referring to the futuristic essay “Ars Brevis,” Dr. Lewis contrasted the humanism of oncology specialists in the present day with the fictional image of data-regurgitating robots programmed to maximize the efficiency of each patient encounter (J Clin Oncol. 2013 May 10;31[14]:1792-4).
Dr. Lewis reminded attendees that to practice medicine without using both “head and heart” undermines the inherent nature of medical care.
Unfortunately, that perspective may not match the public perception of oncologists. Dr. Lewis described his experience of typing “oncologists are” into an Internet search engine and seeing the auto-complete function prompt words such as “criminals,” “evil,” “murderers,” and “confused.”
Obviously, it is hard to establish a trusting patient-doctor relationship if that is the prima facie perception of the oncology specialty.
Dispelling myths and creating community via social media
A primary goal of consultation with a newly-diagnosed cancer patient is for the patient to feel that the oncologist will be there to take care of them, regardless of what the future holds.
Dr. Lewis has found that social media can potentially extend that feeling to a global community of patients, caregivers, and others seeking information relevant to a cancer diagnosis. He believes that oncologists have an opportunity to dispel myths and fears by being attentive to the real-life concerns of patients.
Dr. Lewis took advantage of this opportunity when he underwent a Whipple procedure (pancreaticoduodenectomy) for a pancreatic neuroendocrine tumor. He and the hospital’s media services staff “live-tweeted” his surgery and recovery.
With those tweets, Dr. Lewis demystified each step of a major surgical procedure. From messages he received on social media, Dr. Lewis knows he made the decision to have a Whipple procedure more acceptable to other patients.
His personal medical experience notwithstanding, Dr. Lewis acknowledged that every patient’s circumstances are unique.
Oncologists cannot possibly empathize with every circumstance. However, when they show sensitivity to personal elements of the cancer experience, they shed light on the complicated role they play in patient care and can facilitate good decision-making among patients across the globe.
Social media for professional development and patient care
The publication of his 2011 essay was gratifying for Dr. Lewis, but the finite number of comments he received thereafter illustrated the rather limited audience that traditional academic publications have and the laborious process for subsequent interaction (J Clin Oncol. 2011 Aug 1;29[22]:3103-4).
First as an observer and later as a participant on social media, Dr. Lewis appreciated that teaching points and publications can be amplified by global distribution and the potential for informal bidirectional communication.
Social media platforms enable physicians to connect with a larger audience through participative communication, in which users develop, share, and react to content (N Engl J Med. 2009 Aug 13;361[7]:649-51).
Dr. Lewis reflected on how oncologists are challenged to sort through the thousands of oncology-focused publications annually. Through social media, one can see the studies on which the experts are commenting and appreciate the nuances that contextualize the results. Focused interactions with renowned doctors, at regular intervals, require little formality.
Online journal clubs enable the sharing of ideas, opinions, multimedia resources, and references across institutional and international borders (J Gen Intern Med. 2014 Oct;29[10]:1317-8).
Social media in oncology: Accomplishments and promise
The development of broadband Internet, wireless connectivity, and social media for peer-to-peer and general communication are among the major technological advances that have transformed medical communication.
As an organization, COSMO aims to describe, understand, and improve the use of social media to increase the penetration of evidence-based guidelines and research insights into clinical practice (Future Oncol. 2017 Jun;13[15]:1281-5).
At the inaugural COSMO meeting, areas of progress since COSMO’s inception in 2015 were highlighted, including:
- The involvement of cancer professionals and advocates in multiple distinctive platforms.
- The development of hashtag libraries to aggregate interest groups and topics.
- The refinement of strategies for engaging advocates with attention to inclusiveness.
- A steady trajectory of growth in tweeting at scientific conferences.
An overarching theme of the COSMO meeting was “authenticity,” a virtue that is easy to admire but requires conscious, consistent effort to achieve.
Disclosure of conflicts of interest and avoiding using social media simply as a recruitment tool for clinical trials are basic components of accurate self-representation.
In addition, Dr. Lewis advocated for sharing personal experiences in a component of social media posts so oncologists can show humanity as a feature of their professional online identity and inherent nature.
Dr. Lewis disclosed consultancy with Medscape/WebMD, which are owned by the same parent company as MDedge. He also disclosed relationships with Foundation Medicine, Natera, Exelixis, QED, HalioDX, and Ipsen.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
FROM COSMO 2021
For cervical cancer screening, any strategy is acceptable
Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.
“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.
To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.
First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.
“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”
Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.
In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.
“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.
Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
Primary HPV vs. cytology testing
Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.
Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.
Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.
“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
Self-swabbing could improve screening in certain groups
To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.
Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.
“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”
Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.
“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”
Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.
“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”
Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.
Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.
“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”
“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.
Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.
Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.
“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.
To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.
First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.
“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”
Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.
In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.
“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.
Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
Primary HPV vs. cytology testing
Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.
Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.
Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.
“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
Self-swabbing could improve screening in certain groups
To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.
Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.
“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”
Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.
“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”
Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.
“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”
Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.
Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.
“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”
“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.
Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.
Cytology testing every 3 years, cytology/human papillomavirus cotesting every 5 years, and primary HPV testing every 5 years are similarly effective at reducing cervical cancer risk, said Rachel P. Brook, MD, of the University of California, Los Angeles Health Iris Cantor Women’s Health Center, during a presentation at the annual meeting of the American College of Physicians.
“The most important thing a primary care provider can do is to screen with whatever test is most accessible,” Dr. Brook said in an interview. She also noted that access to screening remains a pressing concern, particularly among underrepresented groups and women in rural areas. Even when women can access testing, follow-up after abnormal results can be inadequate, leading to increased risk of cervical cancer mortality.
To address some of these shortcomings, Dr. Brook provided an overview of current guidelines and appropriate responses to abnormal test results.
First, during her presentation, she noted that guideline recommendations do not apply to patients with additional risk factors, including a compromised immune system, HIV infection, previous treatment of cervical cancer or a high-grade cancerous lesion, or in utero exposure to diethylstilbestrol.
“This is very important,” Dr. Brook said during her presentation. “They should receive individualized care due to their above average risk of cervical cancer.”
Among women with average risk, both the USPSTF 2018 guideline and the ACS 2020 guideline recommend against screening women aged less than 21 years.
In a major change to the most recent ACS guideline, screening women aged 21-24 years is no longer recommended, in contrast with the USPSTF guideline, which still calls for cytology every 3 years for this age group. This recommendation by the USPSTF extends to women aged 25-29 years, a group for which the ACS recommends primary HPV testing every 5 years, cytology/HPV cotesting every 5 years, or cytology testing every 3 years. For both organizations, any of these three testing methods is recommended for women aged 30-65 years, followed by discontinuation of testing after 65 years, given adequate prior screening.
“For all these recommendations and guidelines, they’re pertinent to patients regardless of HPV vaccination status,” Dr. Brook said. But she added that increased rates of HPV vaccination may affect future screening guidelines, as vaccinated patients are more likely to have false positive cytology results because of low-risk HPV strains. This trend may steer future recommendations toward primary HPV testing, Dr. Brook said.
Presently, for applicable age groups, the ACS guideline favors HPV testing alone over cytology alone or cotesting, whereas the USPSTF guideline offers no preference between the three testing strategies.
Primary HPV vs. cytology testing
Dr. Brook said a single negative HPV test provides more than 95% assurance that a patient will not develop cervical cancer or a cancer precursor within the next 5 years. One negative HPV test offers similar reliability to about 3 negative cytology tests.
Switching to a 5-year testing cycle may be unsettling for patients who are used to getting a Pap test every year, but having a conversation about test accuracy can help assuage patient concerns, she said.
Still, Dr. Brook emphasized that any of the three testing strategies is ultimately acceptable.
“The take-home message here is – truly – that any of the recommended screening options will greatly reduce cervical cancer risk,” Dr. Brook said. “So, screen. And if there is any confusion or concern with your patients about which [screening strategy to use], just help them decide on any of the three. But please screen.”
Self-swabbing could improve screening in certain groups
To improve screening rates, particularly for women with poor access and those averse to a speculum exam, Dr. Brook highlighted self-swabbing primary HPV tests, which may soon be available. While no self-swabbing HPV tests are yet approved by the Food and Drug Administration, they offer a 76% sensitivity rate for cervical intraepithelial neoplasia grade 2, and a rate of 85% for CIN3, compared with 91% for physician-collected samples.
Regardless of the exact HPV test, Dr. Brook advised appropriate reflex testing.
“We need to make sure all primary HPV screening tests positive for types other than HPV-16 or -18 will require additional reflex triage testing with cytology,” Dr. Brook said in interview. “If not – if a woman has a primary HPV screening test that is positive and I cannot perform reflex cytology – I have to bring her back for an additional test and speculum exam to get cytology, which is an unnecessary burden to the patient, and also increases testing.”
Kathy L. MacLaughlin, MD, associate professor of family medicine at Mayo Clinic, Rochester, Minn., said this is one drawback to self-swabbing tests in an interview.
“If there is a positive HPV result [with a self-swabbing test], the patient will need to have a clinic appointment for Pap collection [if one of the ‘other’ 12 HPV types are identified], or be referred for a colposcopy [if HPV types 16 or 18 are identified],” Dr. MacLaughlin said. “There need to be plans in place for access to those services.”
Incidentally, it may be women who face barriers to access that need self-swabbing HPV tests the most, according to Dr. MacLaughlin.
“I think there is significant potential to improve screening rates among never-screened and underscreened women and those are the groups for whom this makes the most sense,” she said. “I don’t think anyone is suggesting that women who have the means and interest in scheduling a face-to-face visit for clinician-collected screening switch to self-screening, but it is a promising option [once FDA approved] for reaching other women and reducing disparities in screening rates.”
Dr. MacLaughlin suggested that self-screening programs could operate outside of normal business hours in a variety of settings, such as homes, community centers, and churches.
Until self-screening is an option, Dr. MacLaughlin agreed with Dr. Brook that any of the three testing strategies is suitable for screening, and recommended that primary care providers seize the opportunities presented to them.
“Individual primary care providers can improve screening rates by offering to update cervical cancer screening at a clinic appointment even if that was not the primary indication for the visit, especially for women who are long overdue,” Dr. MacLaughlin said. “If there is just no time to fit in the screening or the patient declines, then order a return visit and have the patient stop at the appointment desk as they leave.”
“I recognize we are asked to fit in more and more in less time, but I’ve found this to be effective when I have capacity in the clinic day to offer it,” she added.
Dr. Brook and Dr. MacLaughlin reported no conflicts of interest.
FROM INTERNAL MEDICINE 2021