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‘Remarkable’ seizure-free rates seen with adjunctive cenobamate
In addition, “high rates of seizure freedom were observed with doses of 200 mg and 400 mg,” investigators reported in the Lancet Neurology.
During a 12-week maintenance phase, 21% of patients who received cenobamate 400 mg/day and 11% who received cenobamate 200 mg/day were seizure free, compared with 1% who received placebo. “These data suggest that cenobamate might be a safe and effective treatment option in patients with uncontrolled focal (partial)-onset seizures,” the authors wrote.
On Nov. 21, 2019, the Food and Drug Administration approved cenobamate tablets, marketed as Xcopri, to treat focal-onset seizures in adults. The agency noted that hypersensitivity reactions have occurred with cenobamate in two randomized, controlled studies and that one patient died when the drug was titrated rapidly during one of the studies that has not been published yet.
Researchers think that cenobamate, a novel tetrazole alkyl carbamate derivative, reduces neuronal excitability “by enhancing the fast and slow inactivation of sodium channels and by inhibiting the persistent component of the sodium channel current,” wrote Gregory L. Krauss, MD, a professor of neurology at Johns Hopkins University, Baltimore, and colleagues.
The rates of seizure freedom with adjunctive cenobamate in the published trial are “a remarkable finding,” wrote Stephan Arnold, MD, an epilepsy specialist at Neurozentrum Nymphenburg in Munich, in an accompanying commentary. Twenty of 95 patients in the 400-mg/day group and 11 of 98 patients in the 200-mg/day group “had no seizures during the 12-week maintenance phase, whereas only 1 patient (1%) of the placebo group remained free of seizures during this period,” Dr. Arnold wrote. “To my knowledge, a seizure freedom rate of 20% or higher has not yet been reported in a placebo-controlled, double-blind trial of anticonvulsive drugs.”
Still, clinical trials in general are limited by their inclusion and exclusion criteria, relatively short maintenance phases, and the need to keep the dosage of concomitant drugs unchanged during the study, Dr. Arnold noted. “Thus, future findings under real-life conditions will reveal the clinical relevance of cenobamate.”
Hypersensitivity reactions led to protocol adjustments
During the trial, the investigators amended the protocol to lower the starting dose of cenobamate and slow the rate of up-titration to address a risk of allergic drug reactions. “Three hypersensitivity reactions, characterized as rash with involvement of at least one other body system, were reported in three patients” who were assigned to receive cenobamate 200 mg/day, the authors wrote. One case of pruritic rash accompanied by pyrexia occurred on day 10 during the initial faster titration protocol. In another case, “a rash and facial swelling occurred on day 57 in a patient who underwent the amended titration protocol.” These two patients discontinued treatment, and the rashes resolved.
“The third hypersensitivity reaction was a serious case of drug reaction with eosinophilia and systemic symptoms that occurred starting on day 24 of treatment in a patient randomly assigned to receive 200 mg/day of cenobamate during the faster initial titration protocol,” the authors wrote. “Treatment was discontinued and the patient was treated with corticosteroids and recovered within 2 months.”
The most common treatment-emergent adverse events included somnolence, dizziness, and fatigue. Most events were mild or moderate. The rate of titration and an inability to adjust the dose of concomitant medications may have contributed to the rate of adverse events, the researchers noted. Treatment-emergent adverse events were most frequent in the 400-mg/day group and led to treatment discontinuation in 20% of patients in this group. An ongoing phase 3 study is assessing a lower starting dose and slower titration rate.
A double-blind, randomized, placebo-controlled trial
The 18-week, double-blind, randomized trial published in Lancet Neurology is one of two phase 2 clinical trials of cenobamate. The other phase 2 study, which lasted 12 weeks, is pending publication. For the 18-week study, researchers at 107 centers in 16 countries enrolled more than 430 adults aged 18-70 years with uncontrolled focal epilepsy. Patients were taking one to three concomitant antiepileptic drugs at stable doses for at least 4 weeks before screening. Patients completed an 8-week baseline assessment, followed by a 6-week titration phase and a 12-week maintenance phase.
“During the 8-week baseline assessment, patients had to have eight or more focal aware (simple partial) seizures with a motor component, focal impaired awareness (complex partial) seizures, or focal to bilateral tonic-clonic (secondarily generalized) seizures, with a seizure-free interval of less than 25 days,” Dr. Krauss and colleagues wrote. In addition, participants had to have at least three of these seizures during the first 4 weeks of the baseline assessment and at least three during the last 4 weeks.
The investigators excluded patients who were taking diazepam, phenytoin, or phenobarbital within 1 month of screening because of a potential drug-drug interaction with cenobamate. Other exclusion criteria included clinically significant psychiatric illness and status epilepticus within 3 months of screening.
The researchers assigned patients 1:1:1:1 to receive cenobamate 100 mg/day, cenobamate 200 mg/day, cenobamate 400 mg/day, or placebo. Percentage change from baseline in focal seizure frequency averaged over 28 days during the 18-week treatment period was the primary efficacy outcome for the FDA. The responder rate (the percentage of patients with at least a 50% reduction from baseline in focal seizure frequency) during the 12-week maintenance phase was the primary efficacy outcome for the European Medicines Agency.
The investigators screened 533 patients and assigned 437 to treatment groups. The modified intention-to-treat population included 434 patients, the modified intention-to-treat maintenance-phase population included 397 patients, and the safety population included 437 patients. The most frequently used concomitant medications were levetiracetam (43%), lamotrigine (32%), and carbamazepine (28%).
The median percentage change from baseline in focal seizure frequency per 28 days during treatment was –24% for the placebo group and –35.5% for the cenobamate 100-mg group. The cenobamate 200 mg group and the cenobamate 400-mg/day group each had a change of –55%.
Responder rates during the maintenance phase were 25% for the placebo group, 40% for the 100-mg group, 56% for the 200-mg group, and 64% for the 400-mg group.
The implications of seizure freedom
The authors acknowledged that it is “difficult to interpret seizure freedom in clinical trials given the constraints of the study designs ... which do not reflect real-life practice. Nonetheless, seizure freedom is of great clinical significance to patient quality of life and the rates reported in this study are notable relative to all other pivotal studies of antiepileptic drug treatment in uncontrolled focal seizures over the past 25 years.”
Rates of seizure freedom represent a crucial outcome measure, Dr. Arnold wrote in his commentary.
“For individual patients, it is not a seizure reduction of 50% or even higher that counts, since this effect will not allow them to drive a car or to work under circumstances bearing increased health risks,” he wrote. “Even when seizure are infrequent, patients nevertheless face the risks of falls, fractures, drowning, and sudden unexpected death in epilepsy. It is complete seizure control that gives rise for hope of an independent lifestyle.”
The study was funded by SK Life Science, the developer of cenobamate. One of the study authors is an employee of SK Life Science. Dr. Krauss is a consultant or advisor for Eisai, Otsuka, and Shire and has received research support from Biogen, SK Life Science, and UCB. Dr. Arnold had no competing interests.
SOURCE: Krauss GL et al. Lancet Neurol. 2019 Nov 13. doi: 10.1016/S1474-4422(19)30399-0.
In addition, “high rates of seizure freedom were observed with doses of 200 mg and 400 mg,” investigators reported in the Lancet Neurology.
During a 12-week maintenance phase, 21% of patients who received cenobamate 400 mg/day and 11% who received cenobamate 200 mg/day were seizure free, compared with 1% who received placebo. “These data suggest that cenobamate might be a safe and effective treatment option in patients with uncontrolled focal (partial)-onset seizures,” the authors wrote.
On Nov. 21, 2019, the Food and Drug Administration approved cenobamate tablets, marketed as Xcopri, to treat focal-onset seizures in adults. The agency noted that hypersensitivity reactions have occurred with cenobamate in two randomized, controlled studies and that one patient died when the drug was titrated rapidly during one of the studies that has not been published yet.
Researchers think that cenobamate, a novel tetrazole alkyl carbamate derivative, reduces neuronal excitability “by enhancing the fast and slow inactivation of sodium channels and by inhibiting the persistent component of the sodium channel current,” wrote Gregory L. Krauss, MD, a professor of neurology at Johns Hopkins University, Baltimore, and colleagues.
The rates of seizure freedom with adjunctive cenobamate in the published trial are “a remarkable finding,” wrote Stephan Arnold, MD, an epilepsy specialist at Neurozentrum Nymphenburg in Munich, in an accompanying commentary. Twenty of 95 patients in the 400-mg/day group and 11 of 98 patients in the 200-mg/day group “had no seizures during the 12-week maintenance phase, whereas only 1 patient (1%) of the placebo group remained free of seizures during this period,” Dr. Arnold wrote. “To my knowledge, a seizure freedom rate of 20% or higher has not yet been reported in a placebo-controlled, double-blind trial of anticonvulsive drugs.”
Still, clinical trials in general are limited by their inclusion and exclusion criteria, relatively short maintenance phases, and the need to keep the dosage of concomitant drugs unchanged during the study, Dr. Arnold noted. “Thus, future findings under real-life conditions will reveal the clinical relevance of cenobamate.”
Hypersensitivity reactions led to protocol adjustments
During the trial, the investigators amended the protocol to lower the starting dose of cenobamate and slow the rate of up-titration to address a risk of allergic drug reactions. “Three hypersensitivity reactions, characterized as rash with involvement of at least one other body system, were reported in three patients” who were assigned to receive cenobamate 200 mg/day, the authors wrote. One case of pruritic rash accompanied by pyrexia occurred on day 10 during the initial faster titration protocol. In another case, “a rash and facial swelling occurred on day 57 in a patient who underwent the amended titration protocol.” These two patients discontinued treatment, and the rashes resolved.
“The third hypersensitivity reaction was a serious case of drug reaction with eosinophilia and systemic symptoms that occurred starting on day 24 of treatment in a patient randomly assigned to receive 200 mg/day of cenobamate during the faster initial titration protocol,” the authors wrote. “Treatment was discontinued and the patient was treated with corticosteroids and recovered within 2 months.”
The most common treatment-emergent adverse events included somnolence, dizziness, and fatigue. Most events were mild or moderate. The rate of titration and an inability to adjust the dose of concomitant medications may have contributed to the rate of adverse events, the researchers noted. Treatment-emergent adverse events were most frequent in the 400-mg/day group and led to treatment discontinuation in 20% of patients in this group. An ongoing phase 3 study is assessing a lower starting dose and slower titration rate.
A double-blind, randomized, placebo-controlled trial
The 18-week, double-blind, randomized trial published in Lancet Neurology is one of two phase 2 clinical trials of cenobamate. The other phase 2 study, which lasted 12 weeks, is pending publication. For the 18-week study, researchers at 107 centers in 16 countries enrolled more than 430 adults aged 18-70 years with uncontrolled focal epilepsy. Patients were taking one to three concomitant antiepileptic drugs at stable doses for at least 4 weeks before screening. Patients completed an 8-week baseline assessment, followed by a 6-week titration phase and a 12-week maintenance phase.
“During the 8-week baseline assessment, patients had to have eight or more focal aware (simple partial) seizures with a motor component, focal impaired awareness (complex partial) seizures, or focal to bilateral tonic-clonic (secondarily generalized) seizures, with a seizure-free interval of less than 25 days,” Dr. Krauss and colleagues wrote. In addition, participants had to have at least three of these seizures during the first 4 weeks of the baseline assessment and at least three during the last 4 weeks.
The investigators excluded patients who were taking diazepam, phenytoin, or phenobarbital within 1 month of screening because of a potential drug-drug interaction with cenobamate. Other exclusion criteria included clinically significant psychiatric illness and status epilepticus within 3 months of screening.
The researchers assigned patients 1:1:1:1 to receive cenobamate 100 mg/day, cenobamate 200 mg/day, cenobamate 400 mg/day, or placebo. Percentage change from baseline in focal seizure frequency averaged over 28 days during the 18-week treatment period was the primary efficacy outcome for the FDA. The responder rate (the percentage of patients with at least a 50% reduction from baseline in focal seizure frequency) during the 12-week maintenance phase was the primary efficacy outcome for the European Medicines Agency.
The investigators screened 533 patients and assigned 437 to treatment groups. The modified intention-to-treat population included 434 patients, the modified intention-to-treat maintenance-phase population included 397 patients, and the safety population included 437 patients. The most frequently used concomitant medications were levetiracetam (43%), lamotrigine (32%), and carbamazepine (28%).
The median percentage change from baseline in focal seizure frequency per 28 days during treatment was –24% for the placebo group and –35.5% for the cenobamate 100-mg group. The cenobamate 200 mg group and the cenobamate 400-mg/day group each had a change of –55%.
Responder rates during the maintenance phase were 25% for the placebo group, 40% for the 100-mg group, 56% for the 200-mg group, and 64% for the 400-mg group.
The implications of seizure freedom
The authors acknowledged that it is “difficult to interpret seizure freedom in clinical trials given the constraints of the study designs ... which do not reflect real-life practice. Nonetheless, seizure freedom is of great clinical significance to patient quality of life and the rates reported in this study are notable relative to all other pivotal studies of antiepileptic drug treatment in uncontrolled focal seizures over the past 25 years.”
Rates of seizure freedom represent a crucial outcome measure, Dr. Arnold wrote in his commentary.
“For individual patients, it is not a seizure reduction of 50% or even higher that counts, since this effect will not allow them to drive a car or to work under circumstances bearing increased health risks,” he wrote. “Even when seizure are infrequent, patients nevertheless face the risks of falls, fractures, drowning, and sudden unexpected death in epilepsy. It is complete seizure control that gives rise for hope of an independent lifestyle.”
The study was funded by SK Life Science, the developer of cenobamate. One of the study authors is an employee of SK Life Science. Dr. Krauss is a consultant or advisor for Eisai, Otsuka, and Shire and has received research support from Biogen, SK Life Science, and UCB. Dr. Arnold had no competing interests.
SOURCE: Krauss GL et al. Lancet Neurol. 2019 Nov 13. doi: 10.1016/S1474-4422(19)30399-0.
In addition, “high rates of seizure freedom were observed with doses of 200 mg and 400 mg,” investigators reported in the Lancet Neurology.
During a 12-week maintenance phase, 21% of patients who received cenobamate 400 mg/day and 11% who received cenobamate 200 mg/day were seizure free, compared with 1% who received placebo. “These data suggest that cenobamate might be a safe and effective treatment option in patients with uncontrolled focal (partial)-onset seizures,” the authors wrote.
On Nov. 21, 2019, the Food and Drug Administration approved cenobamate tablets, marketed as Xcopri, to treat focal-onset seizures in adults. The agency noted that hypersensitivity reactions have occurred with cenobamate in two randomized, controlled studies and that one patient died when the drug was titrated rapidly during one of the studies that has not been published yet.
Researchers think that cenobamate, a novel tetrazole alkyl carbamate derivative, reduces neuronal excitability “by enhancing the fast and slow inactivation of sodium channels and by inhibiting the persistent component of the sodium channel current,” wrote Gregory L. Krauss, MD, a professor of neurology at Johns Hopkins University, Baltimore, and colleagues.
The rates of seizure freedom with adjunctive cenobamate in the published trial are “a remarkable finding,” wrote Stephan Arnold, MD, an epilepsy specialist at Neurozentrum Nymphenburg in Munich, in an accompanying commentary. Twenty of 95 patients in the 400-mg/day group and 11 of 98 patients in the 200-mg/day group “had no seizures during the 12-week maintenance phase, whereas only 1 patient (1%) of the placebo group remained free of seizures during this period,” Dr. Arnold wrote. “To my knowledge, a seizure freedom rate of 20% or higher has not yet been reported in a placebo-controlled, double-blind trial of anticonvulsive drugs.”
Still, clinical trials in general are limited by their inclusion and exclusion criteria, relatively short maintenance phases, and the need to keep the dosage of concomitant drugs unchanged during the study, Dr. Arnold noted. “Thus, future findings under real-life conditions will reveal the clinical relevance of cenobamate.”
Hypersensitivity reactions led to protocol adjustments
During the trial, the investigators amended the protocol to lower the starting dose of cenobamate and slow the rate of up-titration to address a risk of allergic drug reactions. “Three hypersensitivity reactions, characterized as rash with involvement of at least one other body system, were reported in three patients” who were assigned to receive cenobamate 200 mg/day, the authors wrote. One case of pruritic rash accompanied by pyrexia occurred on day 10 during the initial faster titration protocol. In another case, “a rash and facial swelling occurred on day 57 in a patient who underwent the amended titration protocol.” These two patients discontinued treatment, and the rashes resolved.
“The third hypersensitivity reaction was a serious case of drug reaction with eosinophilia and systemic symptoms that occurred starting on day 24 of treatment in a patient randomly assigned to receive 200 mg/day of cenobamate during the faster initial titration protocol,” the authors wrote. “Treatment was discontinued and the patient was treated with corticosteroids and recovered within 2 months.”
The most common treatment-emergent adverse events included somnolence, dizziness, and fatigue. Most events were mild or moderate. The rate of titration and an inability to adjust the dose of concomitant medications may have contributed to the rate of adverse events, the researchers noted. Treatment-emergent adverse events were most frequent in the 400-mg/day group and led to treatment discontinuation in 20% of patients in this group. An ongoing phase 3 study is assessing a lower starting dose and slower titration rate.
A double-blind, randomized, placebo-controlled trial
The 18-week, double-blind, randomized trial published in Lancet Neurology is one of two phase 2 clinical trials of cenobamate. The other phase 2 study, which lasted 12 weeks, is pending publication. For the 18-week study, researchers at 107 centers in 16 countries enrolled more than 430 adults aged 18-70 years with uncontrolled focal epilepsy. Patients were taking one to three concomitant antiepileptic drugs at stable doses for at least 4 weeks before screening. Patients completed an 8-week baseline assessment, followed by a 6-week titration phase and a 12-week maintenance phase.
“During the 8-week baseline assessment, patients had to have eight or more focal aware (simple partial) seizures with a motor component, focal impaired awareness (complex partial) seizures, or focal to bilateral tonic-clonic (secondarily generalized) seizures, with a seizure-free interval of less than 25 days,” Dr. Krauss and colleagues wrote. In addition, participants had to have at least three of these seizures during the first 4 weeks of the baseline assessment and at least three during the last 4 weeks.
The investigators excluded patients who were taking diazepam, phenytoin, or phenobarbital within 1 month of screening because of a potential drug-drug interaction with cenobamate. Other exclusion criteria included clinically significant psychiatric illness and status epilepticus within 3 months of screening.
The researchers assigned patients 1:1:1:1 to receive cenobamate 100 mg/day, cenobamate 200 mg/day, cenobamate 400 mg/day, or placebo. Percentage change from baseline in focal seizure frequency averaged over 28 days during the 18-week treatment period was the primary efficacy outcome for the FDA. The responder rate (the percentage of patients with at least a 50% reduction from baseline in focal seizure frequency) during the 12-week maintenance phase was the primary efficacy outcome for the European Medicines Agency.
The investigators screened 533 patients and assigned 437 to treatment groups. The modified intention-to-treat population included 434 patients, the modified intention-to-treat maintenance-phase population included 397 patients, and the safety population included 437 patients. The most frequently used concomitant medications were levetiracetam (43%), lamotrigine (32%), and carbamazepine (28%).
The median percentage change from baseline in focal seizure frequency per 28 days during treatment was –24% for the placebo group and –35.5% for the cenobamate 100-mg group. The cenobamate 200 mg group and the cenobamate 400-mg/day group each had a change of –55%.
Responder rates during the maintenance phase were 25% for the placebo group, 40% for the 100-mg group, 56% for the 200-mg group, and 64% for the 400-mg group.
The implications of seizure freedom
The authors acknowledged that it is “difficult to interpret seizure freedom in clinical trials given the constraints of the study designs ... which do not reflect real-life practice. Nonetheless, seizure freedom is of great clinical significance to patient quality of life and the rates reported in this study are notable relative to all other pivotal studies of antiepileptic drug treatment in uncontrolled focal seizures over the past 25 years.”
Rates of seizure freedom represent a crucial outcome measure, Dr. Arnold wrote in his commentary.
“For individual patients, it is not a seizure reduction of 50% or even higher that counts, since this effect will not allow them to drive a car or to work under circumstances bearing increased health risks,” he wrote. “Even when seizure are infrequent, patients nevertheless face the risks of falls, fractures, drowning, and sudden unexpected death in epilepsy. It is complete seizure control that gives rise for hope of an independent lifestyle.”
The study was funded by SK Life Science, the developer of cenobamate. One of the study authors is an employee of SK Life Science. Dr. Krauss is a consultant or advisor for Eisai, Otsuka, and Shire and has received research support from Biogen, SK Life Science, and UCB. Dr. Arnold had no competing interests.
SOURCE: Krauss GL et al. Lancet Neurol. 2019 Nov 13. doi: 10.1016/S1474-4422(19)30399-0.
FROM LANCET NEUROLOGY
Certolizumab safety profile varies widely across indications
MADRID – , Andrew Blauvelt, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
He presented a comprehensive analysis of safety data from all 49 clinical trials of the tumor necrosis factor inhibitor for its approved indications. The data set included 11,317 patients who received certolizumab for a collective 21,695 person-years in 27 trials in rheumatoid arthritis patients, 5 in psoriasis, 15 for Crohn’s disease, and one trial each for axial spondyloarthritis and psoriatic arthritis.
“It’s not real-world data, but it is a large group of patients [studied] over many years,” noted Dr. Blauvelt, a dermatologist and president of the Oregon Medical Research Center, Portland.
As a renowned authority on psoriasis, he was part of a multidisciplinary expert panel commissioned by UCB to analyze serious adverse events in the complete clinical trials experience involving the company’s tumor necrosis factor inhibitor certolizumab (Cimzia). The panel included experts from rheumatology, gastroenterology, epidemiology, and other disciplines.
The key takeaway: “When you think about the serious side effects of the drug, you have to think about what the indication is, whether the patients are on systemic corticosteroids, and whether they’re heavy or not,” Dr. Blauvelt said.
Take, for example, the risk of serious infections requiring treatment with intravenous antibiotics. The incidence rates ranged from a low of 1.5 per 100 patient-years in psoriasis patients on certolizumab to a high of 5.97 in those with Crohn’s disease, with rates of 3.44 cases per 100 patient-years among rheumatoid arthritis patients and 1.64-1.67 in those with psoriatic arthritis and ankylosing spondylitis, respectively. Patients with Crohn’s disease were 2.22-fold more likely than were those with rheumatoid arthritis to experience a serious infection during their clinical trial experience on certolizumab. In contrast, psoriasis patients had a 52% relative risk reduction and those with psoriatic arthritis were 31% less likely to develop a serious infection compared with those with rheumatoid arthritis.
The explanation for these highly variable serious infection rates lies in part on the huge differences in the concurrent use of systemic corticosteroids with certolizumab across indications. A mere 3.3% of psoriasis patients were also on steroids, compared with 46.2% of rheumatoid arthritis patients, 50.8% of those with ankylosing spondylitis, and about 25% of the Crohn’s disease and psoriatic arthritis patients, he noted.
Advanced age was independently associated with increased risk of serious infections. Patients aged 65 or older were 1.68-fold more likely to experience this event than were those under age 45. And patients whose disease duration was 10 years or more at baseline had a 1.36-fold increased serious infection risk compared with those who had less than a 1-year-long disease history, independent of which disease they had.
The prevalence of baseline obesity varied by indication. The mean body mass index was 30.1 kg/m2 in the psoriasis patients, 29.8 kg/m2 in those with psoriatic arthritis, lowest at 24 kg/m2 in Crohn’s disease patients, and a bit over 27 kg/m2 in those with rheumatoid arthritis or ankylosing spondylitis.
Obesity alone was not an independent risk factor for serious infection in certolizumab-treated patients; however, the combination of a BMI of 30 kg/m2 or more plus systemic corticosteroid use was associated with a greater risk than with steroids alone.
Based upon a multivariate regression analysis adjusted for age, sex, indication, disease duration, use of methotrexate, and prior use of other TNF inhibitors, the investigators calculated that in patients with Crohn’s disease 16.6% of serious infections in patients on certolizumab were attributable to systemic corticosteroid use.
Risks of major adverse cardiovascular events and cancer on certolizumab
The risk of major adverse cardiovascular events (MACE) while on certolizumab ranged from a high of 0.62 MACE events per 100 patient-years in the rheumatoid arthritis population to a low of 0.1 per 100 patient-years in patients treated for Crohn’s disease or ankylosing spondylitis. Psoriasis and psoriatic arthritis patients had MACE rates of 0.27 and 0.54, respectively.
Obesity was independently associated with increased risk of an acute MI and other MACEs. So was advanced age. No surprises there. The investigators calculated that 16.7% of MACEs in patients on certolizumab were attributable to obesity and another 20.9% were attributable to use of systemic corticosteroids.
The incidence rate for all malignancies, including nonmelanoma skin cancer, ranged from a low of 0.46 cases per 100 patient-years in the psoriatic arthritis cohort on certolizumab to a high of 0.93 in those with rheumatoid arthritis, with rates of 0.68, 0.73, and 0.51 in patients with psoriasis, Crohn’s disease, and ankylosing spondylitis, respectively.
Neither systemic corticosteroids, obesity, disease duration, or prior exposure to a TNF inhibitor was linked to increased risk of cancer in patients on certolizumab. The standout risk factor was age: Patients who were 65 or older at baseline were 11.4-fold more likely to develop cancer during participation in their clinical trial than were those younger than 45. Those who were 45 to 65 years old were 4.3-fold more likely to be diagnosed with a malignancy than were those younger than age 45.
Of note, concomitant use of methotrexate was associated with a statistically significant 28% reduction in malignancy risk.
Dr. Blauvelt reported serving as a consultant to and receiving research funding from UCB, the study sponsor, as well as more than two dozen other pharmaceutical companies.
SOURCE: Blauvelt A. EADV Congress, Abstract FC04.06.
MADRID – , Andrew Blauvelt, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
He presented a comprehensive analysis of safety data from all 49 clinical trials of the tumor necrosis factor inhibitor for its approved indications. The data set included 11,317 patients who received certolizumab for a collective 21,695 person-years in 27 trials in rheumatoid arthritis patients, 5 in psoriasis, 15 for Crohn’s disease, and one trial each for axial spondyloarthritis and psoriatic arthritis.
“It’s not real-world data, but it is a large group of patients [studied] over many years,” noted Dr. Blauvelt, a dermatologist and president of the Oregon Medical Research Center, Portland.
As a renowned authority on psoriasis, he was part of a multidisciplinary expert panel commissioned by UCB to analyze serious adverse events in the complete clinical trials experience involving the company’s tumor necrosis factor inhibitor certolizumab (Cimzia). The panel included experts from rheumatology, gastroenterology, epidemiology, and other disciplines.
The key takeaway: “When you think about the serious side effects of the drug, you have to think about what the indication is, whether the patients are on systemic corticosteroids, and whether they’re heavy or not,” Dr. Blauvelt said.
Take, for example, the risk of serious infections requiring treatment with intravenous antibiotics. The incidence rates ranged from a low of 1.5 per 100 patient-years in psoriasis patients on certolizumab to a high of 5.97 in those with Crohn’s disease, with rates of 3.44 cases per 100 patient-years among rheumatoid arthritis patients and 1.64-1.67 in those with psoriatic arthritis and ankylosing spondylitis, respectively. Patients with Crohn’s disease were 2.22-fold more likely than were those with rheumatoid arthritis to experience a serious infection during their clinical trial experience on certolizumab. In contrast, psoriasis patients had a 52% relative risk reduction and those with psoriatic arthritis were 31% less likely to develop a serious infection compared with those with rheumatoid arthritis.
The explanation for these highly variable serious infection rates lies in part on the huge differences in the concurrent use of systemic corticosteroids with certolizumab across indications. A mere 3.3% of psoriasis patients were also on steroids, compared with 46.2% of rheumatoid arthritis patients, 50.8% of those with ankylosing spondylitis, and about 25% of the Crohn’s disease and psoriatic arthritis patients, he noted.
Advanced age was independently associated with increased risk of serious infections. Patients aged 65 or older were 1.68-fold more likely to experience this event than were those under age 45. And patients whose disease duration was 10 years or more at baseline had a 1.36-fold increased serious infection risk compared with those who had less than a 1-year-long disease history, independent of which disease they had.
The prevalence of baseline obesity varied by indication. The mean body mass index was 30.1 kg/m2 in the psoriasis patients, 29.8 kg/m2 in those with psoriatic arthritis, lowest at 24 kg/m2 in Crohn’s disease patients, and a bit over 27 kg/m2 in those with rheumatoid arthritis or ankylosing spondylitis.
Obesity alone was not an independent risk factor for serious infection in certolizumab-treated patients; however, the combination of a BMI of 30 kg/m2 or more plus systemic corticosteroid use was associated with a greater risk than with steroids alone.
Based upon a multivariate regression analysis adjusted for age, sex, indication, disease duration, use of methotrexate, and prior use of other TNF inhibitors, the investigators calculated that in patients with Crohn’s disease 16.6% of serious infections in patients on certolizumab were attributable to systemic corticosteroid use.
Risks of major adverse cardiovascular events and cancer on certolizumab
The risk of major adverse cardiovascular events (MACE) while on certolizumab ranged from a high of 0.62 MACE events per 100 patient-years in the rheumatoid arthritis population to a low of 0.1 per 100 patient-years in patients treated for Crohn’s disease or ankylosing spondylitis. Psoriasis and psoriatic arthritis patients had MACE rates of 0.27 and 0.54, respectively.
Obesity was independently associated with increased risk of an acute MI and other MACEs. So was advanced age. No surprises there. The investigators calculated that 16.7% of MACEs in patients on certolizumab were attributable to obesity and another 20.9% were attributable to use of systemic corticosteroids.
The incidence rate for all malignancies, including nonmelanoma skin cancer, ranged from a low of 0.46 cases per 100 patient-years in the psoriatic arthritis cohort on certolizumab to a high of 0.93 in those with rheumatoid arthritis, with rates of 0.68, 0.73, and 0.51 in patients with psoriasis, Crohn’s disease, and ankylosing spondylitis, respectively.
Neither systemic corticosteroids, obesity, disease duration, or prior exposure to a TNF inhibitor was linked to increased risk of cancer in patients on certolizumab. The standout risk factor was age: Patients who were 65 or older at baseline were 11.4-fold more likely to develop cancer during participation in their clinical trial than were those younger than 45. Those who were 45 to 65 years old were 4.3-fold more likely to be diagnosed with a malignancy than were those younger than age 45.
Of note, concomitant use of methotrexate was associated with a statistically significant 28% reduction in malignancy risk.
Dr. Blauvelt reported serving as a consultant to and receiving research funding from UCB, the study sponsor, as well as more than two dozen other pharmaceutical companies.
SOURCE: Blauvelt A. EADV Congress, Abstract FC04.06.
MADRID – , Andrew Blauvelt, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
He presented a comprehensive analysis of safety data from all 49 clinical trials of the tumor necrosis factor inhibitor for its approved indications. The data set included 11,317 patients who received certolizumab for a collective 21,695 person-years in 27 trials in rheumatoid arthritis patients, 5 in psoriasis, 15 for Crohn’s disease, and one trial each for axial spondyloarthritis and psoriatic arthritis.
“It’s not real-world data, but it is a large group of patients [studied] over many years,” noted Dr. Blauvelt, a dermatologist and president of the Oregon Medical Research Center, Portland.
As a renowned authority on psoriasis, he was part of a multidisciplinary expert panel commissioned by UCB to analyze serious adverse events in the complete clinical trials experience involving the company’s tumor necrosis factor inhibitor certolizumab (Cimzia). The panel included experts from rheumatology, gastroenterology, epidemiology, and other disciplines.
The key takeaway: “When you think about the serious side effects of the drug, you have to think about what the indication is, whether the patients are on systemic corticosteroids, and whether they’re heavy or not,” Dr. Blauvelt said.
Take, for example, the risk of serious infections requiring treatment with intravenous antibiotics. The incidence rates ranged from a low of 1.5 per 100 patient-years in psoriasis patients on certolizumab to a high of 5.97 in those with Crohn’s disease, with rates of 3.44 cases per 100 patient-years among rheumatoid arthritis patients and 1.64-1.67 in those with psoriatic arthritis and ankylosing spondylitis, respectively. Patients with Crohn’s disease were 2.22-fold more likely than were those with rheumatoid arthritis to experience a serious infection during their clinical trial experience on certolizumab. In contrast, psoriasis patients had a 52% relative risk reduction and those with psoriatic arthritis were 31% less likely to develop a serious infection compared with those with rheumatoid arthritis.
The explanation for these highly variable serious infection rates lies in part on the huge differences in the concurrent use of systemic corticosteroids with certolizumab across indications. A mere 3.3% of psoriasis patients were also on steroids, compared with 46.2% of rheumatoid arthritis patients, 50.8% of those with ankylosing spondylitis, and about 25% of the Crohn’s disease and psoriatic arthritis patients, he noted.
Advanced age was independently associated with increased risk of serious infections. Patients aged 65 or older were 1.68-fold more likely to experience this event than were those under age 45. And patients whose disease duration was 10 years or more at baseline had a 1.36-fold increased serious infection risk compared with those who had less than a 1-year-long disease history, independent of which disease they had.
The prevalence of baseline obesity varied by indication. The mean body mass index was 30.1 kg/m2 in the psoriasis patients, 29.8 kg/m2 in those with psoriatic arthritis, lowest at 24 kg/m2 in Crohn’s disease patients, and a bit over 27 kg/m2 in those with rheumatoid arthritis or ankylosing spondylitis.
Obesity alone was not an independent risk factor for serious infection in certolizumab-treated patients; however, the combination of a BMI of 30 kg/m2 or more plus systemic corticosteroid use was associated with a greater risk than with steroids alone.
Based upon a multivariate regression analysis adjusted for age, sex, indication, disease duration, use of methotrexate, and prior use of other TNF inhibitors, the investigators calculated that in patients with Crohn’s disease 16.6% of serious infections in patients on certolizumab were attributable to systemic corticosteroid use.
Risks of major adverse cardiovascular events and cancer on certolizumab
The risk of major adverse cardiovascular events (MACE) while on certolizumab ranged from a high of 0.62 MACE events per 100 patient-years in the rheumatoid arthritis population to a low of 0.1 per 100 patient-years in patients treated for Crohn’s disease or ankylosing spondylitis. Psoriasis and psoriatic arthritis patients had MACE rates of 0.27 and 0.54, respectively.
Obesity was independently associated with increased risk of an acute MI and other MACEs. So was advanced age. No surprises there. The investigators calculated that 16.7% of MACEs in patients on certolizumab were attributable to obesity and another 20.9% were attributable to use of systemic corticosteroids.
The incidence rate for all malignancies, including nonmelanoma skin cancer, ranged from a low of 0.46 cases per 100 patient-years in the psoriatic arthritis cohort on certolizumab to a high of 0.93 in those with rheumatoid arthritis, with rates of 0.68, 0.73, and 0.51 in patients with psoriasis, Crohn’s disease, and ankylosing spondylitis, respectively.
Neither systemic corticosteroids, obesity, disease duration, or prior exposure to a TNF inhibitor was linked to increased risk of cancer in patients on certolizumab. The standout risk factor was age: Patients who were 65 or older at baseline were 11.4-fold more likely to develop cancer during participation in their clinical trial than were those younger than 45. Those who were 45 to 65 years old were 4.3-fold more likely to be diagnosed with a malignancy than were those younger than age 45.
Of note, concomitant use of methotrexate was associated with a statistically significant 28% reduction in malignancy risk.
Dr. Blauvelt reported serving as a consultant to and receiving research funding from UCB, the study sponsor, as well as more than two dozen other pharmaceutical companies.
SOURCE: Blauvelt A. EADV Congress, Abstract FC04.06.
REPORTING FROM THE EADV CONGRESS
Is there a (robotic) doctor in the house?
In the 2012 movie “Robot and Frank,” an aging ex-jewel thief named Frank receives a robotic home assistant from his well-meaning son. Frank lives alone and suffers from dementia, and his son hopes that the friendly electronic companion will help keep his father safe, assisting him with housework and improving his cognitive health. Frank initially rejects the idea but changes his mind when he realizes the robot’s talents aren’t limited to domestic chores. He begins teaching the robot new skills, and an unlikely partnership develops. With Frank’s penchant for pilfering and the robot’s digital dexterity, the two of them pull off a multimillion-dollar jewelry heist – and Frank’s outlook improves in ways his son never dreamed possible!
“Robot and Frank” takes place “in the near future,” and while we don’t yet have robotic home companions as capable as the one in the movie, we need not look very far to realize that robotics and artificial intelligence may revolutionize the delivery of health care.
With an aging population and an industry shift toward value-based care, new research has focused on novel ways of avoiding hospitalization and reducing hospital readmission. We have seen a resurgence of home visits and the development of telemedicine and remote monitoring.
To stay healthy, patients need to be safe in their home environment and at a minimum need to be able to navigate their activities of daily living. Research published last year by Washington University’s Center for Advanced Studies in Adaptive Systems (CASAS) describes a technology that aims to help patients in their own homes.
The Robot Activity Support system, or RAS, interacts with intelligent sensors in a home environment “to detect and assist with activity errors that may occur in everyday settings.”1 If sensors in the home indicate that a person is experiencing difficulty completing a certain task such as taking a medication or finding a bathroom, a robot can navigate to the person in need and show an instructional video, or lead the patient to the next step in the process.
Another manufacturer is taking a ‘softer’ approach to activity support in the elderly. Toymaker Hasbro has developed a line of robotic cats that provide companionship and comfort. While currently limited to tactile stimulation and simple responses, the manufacturer is working in collaboration with researchers at Brown University to add artificial intelligence capabilities. The goal of the program – Project ARIES (Affordable Robotic Intelligence for Elderly Support) – is to give the cats useful skills such as being able to provide medication and safety reminders while keeping their price point accessible to all.
Other organizations are attempting to take the robotic home health aide idea to the next level. “RUDY,” a robotic companion developed by INF Robotics, is capable of much more than just educating patients and leading them around the house. About the size of small child and wearing a huge smile, Rudy can detect falls, ensure medication adherence, provide social interaction, and even offer remote patient monitoring. According to the manufacturer, it uses natural language processing, machine learning, and a smart social interface to “facilitate trusting relationships between RUDY and older adults.” The idea is to promote acceptance from patients and offer peace of mind to their loved ones. This can be particularly valuable in assisting those with dementia, as a heavy emphasis is placed on socialization and maintaining cognitive stimulation.
Instead of developing novel artificial intelligence platforms, many groups are attempting to leverage existing technologies to assist patients in their homes. One such technology is Amazon’s Echo smart speakers, which became more attractive to health care providers on April 4 of this year with the launch of the Alexa Healthcare Skills Kit. This is Amazon’s HIPAA-compliant application programming interface (API) that allows developers to create ‘skills’ (apps for Echo devices) that can securely handle protected health information.
At launch, Amazon announced six partner organizations who have already written skills for patients. One organization, Boston Children’s Hospital, developed a skill called My Children’s Enhanced Recovery After Surgery (ERAS). According to John Brownstein, the hospital’s Chief Innovation Officer, it “allows patients and caregivers to easily share recovery progress with their care team post surgery ... it is just one example of how voice technology can extend the care and support of our patients beyond the four walls of the hospital.”
Some companies, such as HealthTap, have been working on artificial intelligence to build a platform to allow physicians and patients to interact online. HealthTap is leveraging the wisdom of those interactions to power a deep learning system called Dr. A.I. Available for Alexa and mobile devices, it attempts to assess patients’ symptoms and provide personalized medical explanations and health recommendations. In the developer’s own words: “Dr. A.I. engages with you in an empathetic conversation about your symptoms and overall health ... then gives you appropriate doctor-recommended insights as well as the best possible courses of action you can take on the road to feeling good.”
Some physicians may find this movement troubling, but we believe it represents an early glimpse of what is to come. with no shortage of companies stepping up to meet the demand. While it’s doubtful the robots they create can be easily reprogrammed to steal jewelry, it won’t stop them from trying to steal our jobs. We as physicians will need to continue to hone our skills in compassion and empathy to provide something a computer never can: true care for our patients.
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
Reference
1. Robot-enabled support of daily activities in smart home environments. Cogn Syst Res. 2019 May. doi: 10.1016/j.cogsys.2018.10.032.
In the 2012 movie “Robot and Frank,” an aging ex-jewel thief named Frank receives a robotic home assistant from his well-meaning son. Frank lives alone and suffers from dementia, and his son hopes that the friendly electronic companion will help keep his father safe, assisting him with housework and improving his cognitive health. Frank initially rejects the idea but changes his mind when he realizes the robot’s talents aren’t limited to domestic chores. He begins teaching the robot new skills, and an unlikely partnership develops. With Frank’s penchant for pilfering and the robot’s digital dexterity, the two of them pull off a multimillion-dollar jewelry heist – and Frank’s outlook improves in ways his son never dreamed possible!
“Robot and Frank” takes place “in the near future,” and while we don’t yet have robotic home companions as capable as the one in the movie, we need not look very far to realize that robotics and artificial intelligence may revolutionize the delivery of health care.
With an aging population and an industry shift toward value-based care, new research has focused on novel ways of avoiding hospitalization and reducing hospital readmission. We have seen a resurgence of home visits and the development of telemedicine and remote monitoring.
To stay healthy, patients need to be safe in their home environment and at a minimum need to be able to navigate their activities of daily living. Research published last year by Washington University’s Center for Advanced Studies in Adaptive Systems (CASAS) describes a technology that aims to help patients in their own homes.
The Robot Activity Support system, or RAS, interacts with intelligent sensors in a home environment “to detect and assist with activity errors that may occur in everyday settings.”1 If sensors in the home indicate that a person is experiencing difficulty completing a certain task such as taking a medication or finding a bathroom, a robot can navigate to the person in need and show an instructional video, or lead the patient to the next step in the process.
Another manufacturer is taking a ‘softer’ approach to activity support in the elderly. Toymaker Hasbro has developed a line of robotic cats that provide companionship and comfort. While currently limited to tactile stimulation and simple responses, the manufacturer is working in collaboration with researchers at Brown University to add artificial intelligence capabilities. The goal of the program – Project ARIES (Affordable Robotic Intelligence for Elderly Support) – is to give the cats useful skills such as being able to provide medication and safety reminders while keeping their price point accessible to all.
Other organizations are attempting to take the robotic home health aide idea to the next level. “RUDY,” a robotic companion developed by INF Robotics, is capable of much more than just educating patients and leading them around the house. About the size of small child and wearing a huge smile, Rudy can detect falls, ensure medication adherence, provide social interaction, and even offer remote patient monitoring. According to the manufacturer, it uses natural language processing, machine learning, and a smart social interface to “facilitate trusting relationships between RUDY and older adults.” The idea is to promote acceptance from patients and offer peace of mind to their loved ones. This can be particularly valuable in assisting those with dementia, as a heavy emphasis is placed on socialization and maintaining cognitive stimulation.
Instead of developing novel artificial intelligence platforms, many groups are attempting to leverage existing technologies to assist patients in their homes. One such technology is Amazon’s Echo smart speakers, which became more attractive to health care providers on April 4 of this year with the launch of the Alexa Healthcare Skills Kit. This is Amazon’s HIPAA-compliant application programming interface (API) that allows developers to create ‘skills’ (apps for Echo devices) that can securely handle protected health information.
At launch, Amazon announced six partner organizations who have already written skills for patients. One organization, Boston Children’s Hospital, developed a skill called My Children’s Enhanced Recovery After Surgery (ERAS). According to John Brownstein, the hospital’s Chief Innovation Officer, it “allows patients and caregivers to easily share recovery progress with their care team post surgery ... it is just one example of how voice technology can extend the care and support of our patients beyond the four walls of the hospital.”
Some companies, such as HealthTap, have been working on artificial intelligence to build a platform to allow physicians and patients to interact online. HealthTap is leveraging the wisdom of those interactions to power a deep learning system called Dr. A.I. Available for Alexa and mobile devices, it attempts to assess patients’ symptoms and provide personalized medical explanations and health recommendations. In the developer’s own words: “Dr. A.I. engages with you in an empathetic conversation about your symptoms and overall health ... then gives you appropriate doctor-recommended insights as well as the best possible courses of action you can take on the road to feeling good.”
Some physicians may find this movement troubling, but we believe it represents an early glimpse of what is to come. with no shortage of companies stepping up to meet the demand. While it’s doubtful the robots they create can be easily reprogrammed to steal jewelry, it won’t stop them from trying to steal our jobs. We as physicians will need to continue to hone our skills in compassion and empathy to provide something a computer never can: true care for our patients.
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
Reference
1. Robot-enabled support of daily activities in smart home environments. Cogn Syst Res. 2019 May. doi: 10.1016/j.cogsys.2018.10.032.
In the 2012 movie “Robot and Frank,” an aging ex-jewel thief named Frank receives a robotic home assistant from his well-meaning son. Frank lives alone and suffers from dementia, and his son hopes that the friendly electronic companion will help keep his father safe, assisting him with housework and improving his cognitive health. Frank initially rejects the idea but changes his mind when he realizes the robot’s talents aren’t limited to domestic chores. He begins teaching the robot new skills, and an unlikely partnership develops. With Frank’s penchant for pilfering and the robot’s digital dexterity, the two of them pull off a multimillion-dollar jewelry heist – and Frank’s outlook improves in ways his son never dreamed possible!
“Robot and Frank” takes place “in the near future,” and while we don’t yet have robotic home companions as capable as the one in the movie, we need not look very far to realize that robotics and artificial intelligence may revolutionize the delivery of health care.
With an aging population and an industry shift toward value-based care, new research has focused on novel ways of avoiding hospitalization and reducing hospital readmission. We have seen a resurgence of home visits and the development of telemedicine and remote monitoring.
To stay healthy, patients need to be safe in their home environment and at a minimum need to be able to navigate their activities of daily living. Research published last year by Washington University’s Center for Advanced Studies in Adaptive Systems (CASAS) describes a technology that aims to help patients in their own homes.
The Robot Activity Support system, or RAS, interacts with intelligent sensors in a home environment “to detect and assist with activity errors that may occur in everyday settings.”1 If sensors in the home indicate that a person is experiencing difficulty completing a certain task such as taking a medication or finding a bathroom, a robot can navigate to the person in need and show an instructional video, or lead the patient to the next step in the process.
Another manufacturer is taking a ‘softer’ approach to activity support in the elderly. Toymaker Hasbro has developed a line of robotic cats that provide companionship and comfort. While currently limited to tactile stimulation and simple responses, the manufacturer is working in collaboration with researchers at Brown University to add artificial intelligence capabilities. The goal of the program – Project ARIES (Affordable Robotic Intelligence for Elderly Support) – is to give the cats useful skills such as being able to provide medication and safety reminders while keeping their price point accessible to all.
Other organizations are attempting to take the robotic home health aide idea to the next level. “RUDY,” a robotic companion developed by INF Robotics, is capable of much more than just educating patients and leading them around the house. About the size of small child and wearing a huge smile, Rudy can detect falls, ensure medication adherence, provide social interaction, and even offer remote patient monitoring. According to the manufacturer, it uses natural language processing, machine learning, and a smart social interface to “facilitate trusting relationships between RUDY and older adults.” The idea is to promote acceptance from patients and offer peace of mind to their loved ones. This can be particularly valuable in assisting those with dementia, as a heavy emphasis is placed on socialization and maintaining cognitive stimulation.
Instead of developing novel artificial intelligence platforms, many groups are attempting to leverage existing technologies to assist patients in their homes. One such technology is Amazon’s Echo smart speakers, which became more attractive to health care providers on April 4 of this year with the launch of the Alexa Healthcare Skills Kit. This is Amazon’s HIPAA-compliant application programming interface (API) that allows developers to create ‘skills’ (apps for Echo devices) that can securely handle protected health information.
At launch, Amazon announced six partner organizations who have already written skills for patients. One organization, Boston Children’s Hospital, developed a skill called My Children’s Enhanced Recovery After Surgery (ERAS). According to John Brownstein, the hospital’s Chief Innovation Officer, it “allows patients and caregivers to easily share recovery progress with their care team post surgery ... it is just one example of how voice technology can extend the care and support of our patients beyond the four walls of the hospital.”
Some companies, such as HealthTap, have been working on artificial intelligence to build a platform to allow physicians and patients to interact online. HealthTap is leveraging the wisdom of those interactions to power a deep learning system called Dr. A.I. Available for Alexa and mobile devices, it attempts to assess patients’ symptoms and provide personalized medical explanations and health recommendations. In the developer’s own words: “Dr. A.I. engages with you in an empathetic conversation about your symptoms and overall health ... then gives you appropriate doctor-recommended insights as well as the best possible courses of action you can take on the road to feeling good.”
Some physicians may find this movement troubling, but we believe it represents an early glimpse of what is to come. with no shortage of companies stepping up to meet the demand. While it’s doubtful the robots they create can be easily reprogrammed to steal jewelry, it won’t stop them from trying to steal our jobs. We as physicians will need to continue to hone our skills in compassion and empathy to provide something a computer never can: true care for our patients.
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
Reference
1. Robot-enabled support of daily activities in smart home environments. Cogn Syst Res. 2019 May. doi: 10.1016/j.cogsys.2018.10.032.
Late-onset MS is often more severe than earlier-onset MS
ST. LOUIS –
Whether the pathophysiology is different, or if the disease is simply compounded by the effects of aging, is uncertain. It is likely, however, that patients with late onset are at greater risk of misdiagnosis and delayed treatment, said Mattia Wruble, a 4th-year medical student at the University of Virginia.
The reason is that MS usually presents in young women as relapsing-remitting disease, but late onset is more typically primary progressive, with a higher proportion of men, which is something that has been demonstrated in previous work and also found in the new study.
“What we didn’t expect to find,” however, was greater “disability and higher disability accrual rates” across all subtypes. Late-onset MS “is a worse disease, a more severe disease” that might even need different treatment options, Ms. Wruble said at the American Neurological Association annual meeting.
Ms. Wruble and colleagues compared the charts of 1,381 patients with MS onset before age 50 years, at a median age of 33 years, with 143 patients whose symptoms began at age 50 years or later, at a median of 55 years.
It was one of the largest late-onset MS samples to date. Incidence of the condition is on the rise, but research has been limited. The investigators hoped to address a need for “a better and more thorough characterization of” the disease to aid treatment and improve outcomes, Ms. Wruble said.
There was a higher proportion of men in the late-onset group, 38% vs. 26%. About 75% of patients with early onset had relapsing remitting disease, and 10% had primary progressive disease. The late-onset group was about evenly split between relapsing-remitting and primary progressive MS (P less than .001).
Patients with late onset MS also had a higher degree of disability at their most recent visit across all subtypes (median Expanded Disability Status Scale score of 5 versus 3), despite having a shorter duration of disease (mean 12 vs. 17 years from symptom onset).
Overall disease accrual rate in the late-onset group was twice that of early-onset group, a decline of 0.647 points per year on the EDSS versus 0.357 points (P less than .001). The finding held when limited to early and late relapsing-remitting cases. The accrual rate for late-onset primary and secondary progressive MS was 1.5 times that of early-onset cases.
Transition to secondary progressive disease also was faster in the late-onset group, a mean of about 7 years versus 15-19 years. Patients with late onset also were more likely to have a history of smoking.
The cerebrospinal fluid in late-onset MS generally has fewer unique oligoclonal bands, which are part of the McDonald diagnostic criteria for MS. “The McDonald criteria were made for patients between 20 and 50 years old; maybe they are not the best criteria to diagnose this late-onset group,” Ms. Wruble said.
There was no external funding, and Ms. Wruble had no disclosures.
SOURCE: Wruble M et al. ANA 2019. Abstract S234.
ST. LOUIS –
Whether the pathophysiology is different, or if the disease is simply compounded by the effects of aging, is uncertain. It is likely, however, that patients with late onset are at greater risk of misdiagnosis and delayed treatment, said Mattia Wruble, a 4th-year medical student at the University of Virginia.
The reason is that MS usually presents in young women as relapsing-remitting disease, but late onset is more typically primary progressive, with a higher proportion of men, which is something that has been demonstrated in previous work and also found in the new study.
“What we didn’t expect to find,” however, was greater “disability and higher disability accrual rates” across all subtypes. Late-onset MS “is a worse disease, a more severe disease” that might even need different treatment options, Ms. Wruble said at the American Neurological Association annual meeting.
Ms. Wruble and colleagues compared the charts of 1,381 patients with MS onset before age 50 years, at a median age of 33 years, with 143 patients whose symptoms began at age 50 years or later, at a median of 55 years.
It was one of the largest late-onset MS samples to date. Incidence of the condition is on the rise, but research has been limited. The investigators hoped to address a need for “a better and more thorough characterization of” the disease to aid treatment and improve outcomes, Ms. Wruble said.
There was a higher proportion of men in the late-onset group, 38% vs. 26%. About 75% of patients with early onset had relapsing remitting disease, and 10% had primary progressive disease. The late-onset group was about evenly split between relapsing-remitting and primary progressive MS (P less than .001).
Patients with late onset MS also had a higher degree of disability at their most recent visit across all subtypes (median Expanded Disability Status Scale score of 5 versus 3), despite having a shorter duration of disease (mean 12 vs. 17 years from symptom onset).
Overall disease accrual rate in the late-onset group was twice that of early-onset group, a decline of 0.647 points per year on the EDSS versus 0.357 points (P less than .001). The finding held when limited to early and late relapsing-remitting cases. The accrual rate for late-onset primary and secondary progressive MS was 1.5 times that of early-onset cases.
Transition to secondary progressive disease also was faster in the late-onset group, a mean of about 7 years versus 15-19 years. Patients with late onset also were more likely to have a history of smoking.
The cerebrospinal fluid in late-onset MS generally has fewer unique oligoclonal bands, which are part of the McDonald diagnostic criteria for MS. “The McDonald criteria were made for patients between 20 and 50 years old; maybe they are not the best criteria to diagnose this late-onset group,” Ms. Wruble said.
There was no external funding, and Ms. Wruble had no disclosures.
SOURCE: Wruble M et al. ANA 2019. Abstract S234.
ST. LOUIS –
Whether the pathophysiology is different, or if the disease is simply compounded by the effects of aging, is uncertain. It is likely, however, that patients with late onset are at greater risk of misdiagnosis and delayed treatment, said Mattia Wruble, a 4th-year medical student at the University of Virginia.
The reason is that MS usually presents in young women as relapsing-remitting disease, but late onset is more typically primary progressive, with a higher proportion of men, which is something that has been demonstrated in previous work and also found in the new study.
“What we didn’t expect to find,” however, was greater “disability and higher disability accrual rates” across all subtypes. Late-onset MS “is a worse disease, a more severe disease” that might even need different treatment options, Ms. Wruble said at the American Neurological Association annual meeting.
Ms. Wruble and colleagues compared the charts of 1,381 patients with MS onset before age 50 years, at a median age of 33 years, with 143 patients whose symptoms began at age 50 years or later, at a median of 55 years.
It was one of the largest late-onset MS samples to date. Incidence of the condition is on the rise, but research has been limited. The investigators hoped to address a need for “a better and more thorough characterization of” the disease to aid treatment and improve outcomes, Ms. Wruble said.
There was a higher proportion of men in the late-onset group, 38% vs. 26%. About 75% of patients with early onset had relapsing remitting disease, and 10% had primary progressive disease. The late-onset group was about evenly split between relapsing-remitting and primary progressive MS (P less than .001).
Patients with late onset MS also had a higher degree of disability at their most recent visit across all subtypes (median Expanded Disability Status Scale score of 5 versus 3), despite having a shorter duration of disease (mean 12 vs. 17 years from symptom onset).
Overall disease accrual rate in the late-onset group was twice that of early-onset group, a decline of 0.647 points per year on the EDSS versus 0.357 points (P less than .001). The finding held when limited to early and late relapsing-remitting cases. The accrual rate for late-onset primary and secondary progressive MS was 1.5 times that of early-onset cases.
Transition to secondary progressive disease also was faster in the late-onset group, a mean of about 7 years versus 15-19 years. Patients with late onset also were more likely to have a history of smoking.
The cerebrospinal fluid in late-onset MS generally has fewer unique oligoclonal bands, which are part of the McDonald diagnostic criteria for MS. “The McDonald criteria were made for patients between 20 and 50 years old; maybe they are not the best criteria to diagnose this late-onset group,” Ms. Wruble said.
There was no external funding, and Ms. Wruble had no disclosures.
SOURCE: Wruble M et al. ANA 2019. Abstract S234.
REPORTING FROM ANA 2019
ASCO releases revised version of its Patient-Centered Oncology Payment model
The American Society of Clinical Oncology has made some adjustments to its Patient-Centered Oncology Payment (PCOP) advanced alternative payment model and will now be looking to gain approval from the Physician-Focused Payment Model Technical Advisory Committee (PTAC).
PTAC reviews physician-developed advanced alternative payment models and sends those APMs that are approved to the Centers for Medicare & Medicaid Services’ Center for Medicare & Medicaid Innovation (CMMI) to determine if there will be further testing and possible implementation for use by physicians as part of the APM track of the Quality Payment Program.
Even if approved by PTAC, the ASCO model faces an uphill battle. CMS already has its own Oncology Care Model (OCM), and given the agency’s track record of not testing APMs that have been approved by PTAC, the deck may be stacked against ASCO in terms of getting its model into Medicare.
But officials at ASCO are hoping a PTAC vetting and approval will open the door to its implementation by commercial payers.
“We are now ready to take this to PTAC,” Jeffery Ward, MD, past chair of ASCO’s government relations committee, said in an interview. “I don’t expect any trouble getting through PTAC. The other question is whether CMMI would decide to actually test a model like this, and so far, they have seemed pretty much a one-trick pony, as in they’ve got their Oncology Care Model and they are going to run with it.”
However, Dr. Ward, a medical oncologist at Swedish Cancer Institute of Edmonds, Wash., said that PCOP has been designed with the commercial market in mind and the PTAC recommendation will help validate the model and make it more appealing to commercial payers.
A key feature of the adjusted payment model is that it has taken a lesson learned from CMS’s Oncology Care Model in terms of how to account for the price of drugs. Including the price of drugs in a value-based payment model – the approach taken by the OCM – creates too much variability, Dr. Ward noted. He used lung cancer as an example, noting that the type of lung cancer could have more of an impact on physician spending than any specific treatment decisions a physician can make because the treatment choices may not be there.
“When that happens, whether you are successful or not depends on the luck of the draw instead of the choices you make,” he said.
In an effort not to penalize practices because of their patient mix, PCOP takes the cost of drugs out of the value mix.
“What this model does is it doesn’t hold practices responsible for the cost of the drugs. It holds them responsible for how they utilize the drugs,” he said. “It really begins to make me responsible for making value-based decisions as opposed to just getting lucky and having a cheaper panel of patients.”
Overall, Dr. Ward described the PCOP model as accomplishing the goals of CMS’s APMs by encouraging physicians to treat patients through high-value treatments.
“This model does that by including quality measures that play a role in how much you get paid,” he said. “There are pathways that are value-based pathways and your ability to follow those pathways plays a role in how much you get paid. The amount of care that you send to the ER or the hospital plays a role in how much you get paid. Those things are then used in adjusting what is our fee-for-service model of medicine. So you are still getting paid a base rate based on the care that you give on a fee-for-service model, but that gets adjusted up or down depending on those other characteristics.”
But for the model to have the biggest impact, it needs to be adopted by all payers in a given state or region and used by all physicians, who by the design of the payment model, will have a role in shaping the implementation details.
Savings could come from lower administrative costs at the physician office because there would be no need for separate contracts between payers, something that could generate savings of up to 8%, compared with the current system, Dr. Ward noted.
“This is designed to be a multipayer and multipractice initiative,” he said. “In its grandest form, a state or states would implement this and it would be participated in by all the oncology practices and all of the payers.”
The American Society of Clinical Oncology has made some adjustments to its Patient-Centered Oncology Payment (PCOP) advanced alternative payment model and will now be looking to gain approval from the Physician-Focused Payment Model Technical Advisory Committee (PTAC).
PTAC reviews physician-developed advanced alternative payment models and sends those APMs that are approved to the Centers for Medicare & Medicaid Services’ Center for Medicare & Medicaid Innovation (CMMI) to determine if there will be further testing and possible implementation for use by physicians as part of the APM track of the Quality Payment Program.
Even if approved by PTAC, the ASCO model faces an uphill battle. CMS already has its own Oncology Care Model (OCM), and given the agency’s track record of not testing APMs that have been approved by PTAC, the deck may be stacked against ASCO in terms of getting its model into Medicare.
But officials at ASCO are hoping a PTAC vetting and approval will open the door to its implementation by commercial payers.
“We are now ready to take this to PTAC,” Jeffery Ward, MD, past chair of ASCO’s government relations committee, said in an interview. “I don’t expect any trouble getting through PTAC. The other question is whether CMMI would decide to actually test a model like this, and so far, they have seemed pretty much a one-trick pony, as in they’ve got their Oncology Care Model and they are going to run with it.”
However, Dr. Ward, a medical oncologist at Swedish Cancer Institute of Edmonds, Wash., said that PCOP has been designed with the commercial market in mind and the PTAC recommendation will help validate the model and make it more appealing to commercial payers.
A key feature of the adjusted payment model is that it has taken a lesson learned from CMS’s Oncology Care Model in terms of how to account for the price of drugs. Including the price of drugs in a value-based payment model – the approach taken by the OCM – creates too much variability, Dr. Ward noted. He used lung cancer as an example, noting that the type of lung cancer could have more of an impact on physician spending than any specific treatment decisions a physician can make because the treatment choices may not be there.
“When that happens, whether you are successful or not depends on the luck of the draw instead of the choices you make,” he said.
In an effort not to penalize practices because of their patient mix, PCOP takes the cost of drugs out of the value mix.
“What this model does is it doesn’t hold practices responsible for the cost of the drugs. It holds them responsible for how they utilize the drugs,” he said. “It really begins to make me responsible for making value-based decisions as opposed to just getting lucky and having a cheaper panel of patients.”
Overall, Dr. Ward described the PCOP model as accomplishing the goals of CMS’s APMs by encouraging physicians to treat patients through high-value treatments.
“This model does that by including quality measures that play a role in how much you get paid,” he said. “There are pathways that are value-based pathways and your ability to follow those pathways plays a role in how much you get paid. The amount of care that you send to the ER or the hospital plays a role in how much you get paid. Those things are then used in adjusting what is our fee-for-service model of medicine. So you are still getting paid a base rate based on the care that you give on a fee-for-service model, but that gets adjusted up or down depending on those other characteristics.”
But for the model to have the biggest impact, it needs to be adopted by all payers in a given state or region and used by all physicians, who by the design of the payment model, will have a role in shaping the implementation details.
Savings could come from lower administrative costs at the physician office because there would be no need for separate contracts between payers, something that could generate savings of up to 8%, compared with the current system, Dr. Ward noted.
“This is designed to be a multipayer and multipractice initiative,” he said. “In its grandest form, a state or states would implement this and it would be participated in by all the oncology practices and all of the payers.”
The American Society of Clinical Oncology has made some adjustments to its Patient-Centered Oncology Payment (PCOP) advanced alternative payment model and will now be looking to gain approval from the Physician-Focused Payment Model Technical Advisory Committee (PTAC).
PTAC reviews physician-developed advanced alternative payment models and sends those APMs that are approved to the Centers for Medicare & Medicaid Services’ Center for Medicare & Medicaid Innovation (CMMI) to determine if there will be further testing and possible implementation for use by physicians as part of the APM track of the Quality Payment Program.
Even if approved by PTAC, the ASCO model faces an uphill battle. CMS already has its own Oncology Care Model (OCM), and given the agency’s track record of not testing APMs that have been approved by PTAC, the deck may be stacked against ASCO in terms of getting its model into Medicare.
But officials at ASCO are hoping a PTAC vetting and approval will open the door to its implementation by commercial payers.
“We are now ready to take this to PTAC,” Jeffery Ward, MD, past chair of ASCO’s government relations committee, said in an interview. “I don’t expect any trouble getting through PTAC. The other question is whether CMMI would decide to actually test a model like this, and so far, they have seemed pretty much a one-trick pony, as in they’ve got their Oncology Care Model and they are going to run with it.”
However, Dr. Ward, a medical oncologist at Swedish Cancer Institute of Edmonds, Wash., said that PCOP has been designed with the commercial market in mind and the PTAC recommendation will help validate the model and make it more appealing to commercial payers.
A key feature of the adjusted payment model is that it has taken a lesson learned from CMS’s Oncology Care Model in terms of how to account for the price of drugs. Including the price of drugs in a value-based payment model – the approach taken by the OCM – creates too much variability, Dr. Ward noted. He used lung cancer as an example, noting that the type of lung cancer could have more of an impact on physician spending than any specific treatment decisions a physician can make because the treatment choices may not be there.
“When that happens, whether you are successful or not depends on the luck of the draw instead of the choices you make,” he said.
In an effort not to penalize practices because of their patient mix, PCOP takes the cost of drugs out of the value mix.
“What this model does is it doesn’t hold practices responsible for the cost of the drugs. It holds them responsible for how they utilize the drugs,” he said. “It really begins to make me responsible for making value-based decisions as opposed to just getting lucky and having a cheaper panel of patients.”
Overall, Dr. Ward described the PCOP model as accomplishing the goals of CMS’s APMs by encouraging physicians to treat patients through high-value treatments.
“This model does that by including quality measures that play a role in how much you get paid,” he said. “There are pathways that are value-based pathways and your ability to follow those pathways plays a role in how much you get paid. The amount of care that you send to the ER or the hospital plays a role in how much you get paid. Those things are then used in adjusting what is our fee-for-service model of medicine. So you are still getting paid a base rate based on the care that you give on a fee-for-service model, but that gets adjusted up or down depending on those other characteristics.”
But for the model to have the biggest impact, it needs to be adopted by all payers in a given state or region and used by all physicians, who by the design of the payment model, will have a role in shaping the implementation details.
Savings could come from lower administrative costs at the physician office because there would be no need for separate contracts between payers, something that could generate savings of up to 8%, compared with the current system, Dr. Ward noted.
“This is designed to be a multipayer and multipractice initiative,” he said. “In its grandest form, a state or states would implement this and it would be participated in by all the oncology practices and all of the payers.”
Obesity dropping in kids aged 2-4 years in WIC program
During 2010-2016, the prevalence of obesity among children in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program significantly decreased in 73% of 56 states and territories, Liping Pan, MD, and colleagues reported in the Morbidity and Mortality Weekly Report.
The obesity prevalence decreases varied, but exceeded 3% in Guam, New Jersey, New Mexico, Northern Mariana Islands, Puerto Rico, Utah, and Virginia. Puerto Rico experienced the greatest benefit, with an 8% decrease in obesity among children aged 2-4 years enrolled in the WIC program, wrote Dr. Pan, an epidemiologist at the Centers for Disease Control and Prevention and coauthors.
Although the changes were small, the positive trend gains more import when viewed in light of the country’s long-term obesity trends, Dr. Pan and his team wrote. After a short-lived dip during 2007-2012, obesity has been on the rise among these children, jumping from 8% in 2012 to 14% in 2016. “Thus, even these small decreases indicate progress for this vulnerable WIC population,” the team said.
WIC extends nutritional assistance to families whose income is 185% or less of the federal poverty guideline or are eligible for other programs, as well as being deemed at nutritional risk.
The current study looked at obesity trends during 2010-2016 among 12,403,629 WIC recipients aged 2-4 years in all 50 U.S. states and five territories.
In 2010, obesity prevalence ranged from a low of 10% in Colorado to a high of 22% in Virginia. In Alaska, Puerto Rico, and Virginia, it was 20% or higher. Only in Colorado and Hawaii was obesity prevalence 10% or less among these children.
By 2016, obesity prevalence among children aged 2-4 years ranged from 8% in the Northern Mariana Islands to 19.8% in Alaska. It was less than 20% in all the states and territories, and less than 10% in Colorado, Guam, Hawaii, Northern Mariana Islands, Utah, and Wyoming.
It increased during 2010-2016, however, in Alabama (0.5%), North Carolina (0.6%), and West Virginia (2.2%).
The changes reflect the 2009 program revisions made to adhere to the 2005 Dietary Guidelines for Americans and the infant food and feeding practice guidelines of the American Academy of Pediatrics, Dr. Pan and associates wrote.
“The revised food packages include a broader range of healthy food options; promote fruit, vegetable, and whole wheat product purchases; support breastfeeding; and give WIC state and territory agencies more flexibility to accommodate cultural food preferences,” the authors noted.
In response to the changes, Dr. Pan and associates noted, authorized WIC stores began carrying healthier offerings. Tracking showed that children in the program consumed more fruits, vegetables, and whole grain products and less juice, white bread, and whole milk after the revisions than they did previously.
Despite the good news, childhood obesity rates still are too high and much remains to be done, they noted.
“Multiple approaches are needed to address and eliminate childhood obesity. The National Academy of Medicine and other groups have recommended a comprehensive and integrated approach that calls for positive changes in physical activity and food and beverage environments in multiple settings including home, early care and education [such as nutrition standards for food served], and community [such as neighborhood designs that encourage walking and biking] to promote healthy eating and physical activity for young children. Further implementation of these positive changes across the United States could further the decreases in child-hood obesity,” Dr. Pan and coauthors concluded.
Dr. Pan and coauthors had no financial disclosures.
SOURCE: Pan L et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 22;68(46):1057-61.
During 2010-2016, the prevalence of obesity among children in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program significantly decreased in 73% of 56 states and territories, Liping Pan, MD, and colleagues reported in the Morbidity and Mortality Weekly Report.
The obesity prevalence decreases varied, but exceeded 3% in Guam, New Jersey, New Mexico, Northern Mariana Islands, Puerto Rico, Utah, and Virginia. Puerto Rico experienced the greatest benefit, with an 8% decrease in obesity among children aged 2-4 years enrolled in the WIC program, wrote Dr. Pan, an epidemiologist at the Centers for Disease Control and Prevention and coauthors.
Although the changes were small, the positive trend gains more import when viewed in light of the country’s long-term obesity trends, Dr. Pan and his team wrote. After a short-lived dip during 2007-2012, obesity has been on the rise among these children, jumping from 8% in 2012 to 14% in 2016. “Thus, even these small decreases indicate progress for this vulnerable WIC population,” the team said.
WIC extends nutritional assistance to families whose income is 185% or less of the federal poverty guideline or are eligible for other programs, as well as being deemed at nutritional risk.
The current study looked at obesity trends during 2010-2016 among 12,403,629 WIC recipients aged 2-4 years in all 50 U.S. states and five territories.
In 2010, obesity prevalence ranged from a low of 10% in Colorado to a high of 22% in Virginia. In Alaska, Puerto Rico, and Virginia, it was 20% or higher. Only in Colorado and Hawaii was obesity prevalence 10% or less among these children.
By 2016, obesity prevalence among children aged 2-4 years ranged from 8% in the Northern Mariana Islands to 19.8% in Alaska. It was less than 20% in all the states and territories, and less than 10% in Colorado, Guam, Hawaii, Northern Mariana Islands, Utah, and Wyoming.
It increased during 2010-2016, however, in Alabama (0.5%), North Carolina (0.6%), and West Virginia (2.2%).
The changes reflect the 2009 program revisions made to adhere to the 2005 Dietary Guidelines for Americans and the infant food and feeding practice guidelines of the American Academy of Pediatrics, Dr. Pan and associates wrote.
“The revised food packages include a broader range of healthy food options; promote fruit, vegetable, and whole wheat product purchases; support breastfeeding; and give WIC state and territory agencies more flexibility to accommodate cultural food preferences,” the authors noted.
In response to the changes, Dr. Pan and associates noted, authorized WIC stores began carrying healthier offerings. Tracking showed that children in the program consumed more fruits, vegetables, and whole grain products and less juice, white bread, and whole milk after the revisions than they did previously.
Despite the good news, childhood obesity rates still are too high and much remains to be done, they noted.
“Multiple approaches are needed to address and eliminate childhood obesity. The National Academy of Medicine and other groups have recommended a comprehensive and integrated approach that calls for positive changes in physical activity and food and beverage environments in multiple settings including home, early care and education [such as nutrition standards for food served], and community [such as neighborhood designs that encourage walking and biking] to promote healthy eating and physical activity for young children. Further implementation of these positive changes across the United States could further the decreases in child-hood obesity,” Dr. Pan and coauthors concluded.
Dr. Pan and coauthors had no financial disclosures.
SOURCE: Pan L et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 22;68(46):1057-61.
During 2010-2016, the prevalence of obesity among children in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program significantly decreased in 73% of 56 states and territories, Liping Pan, MD, and colleagues reported in the Morbidity and Mortality Weekly Report.
The obesity prevalence decreases varied, but exceeded 3% in Guam, New Jersey, New Mexico, Northern Mariana Islands, Puerto Rico, Utah, and Virginia. Puerto Rico experienced the greatest benefit, with an 8% decrease in obesity among children aged 2-4 years enrolled in the WIC program, wrote Dr. Pan, an epidemiologist at the Centers for Disease Control and Prevention and coauthors.
Although the changes were small, the positive trend gains more import when viewed in light of the country’s long-term obesity trends, Dr. Pan and his team wrote. After a short-lived dip during 2007-2012, obesity has been on the rise among these children, jumping from 8% in 2012 to 14% in 2016. “Thus, even these small decreases indicate progress for this vulnerable WIC population,” the team said.
WIC extends nutritional assistance to families whose income is 185% or less of the federal poverty guideline or are eligible for other programs, as well as being deemed at nutritional risk.
The current study looked at obesity trends during 2010-2016 among 12,403,629 WIC recipients aged 2-4 years in all 50 U.S. states and five territories.
In 2010, obesity prevalence ranged from a low of 10% in Colorado to a high of 22% in Virginia. In Alaska, Puerto Rico, and Virginia, it was 20% or higher. Only in Colorado and Hawaii was obesity prevalence 10% or less among these children.
By 2016, obesity prevalence among children aged 2-4 years ranged from 8% in the Northern Mariana Islands to 19.8% in Alaska. It was less than 20% in all the states and territories, and less than 10% in Colorado, Guam, Hawaii, Northern Mariana Islands, Utah, and Wyoming.
It increased during 2010-2016, however, in Alabama (0.5%), North Carolina (0.6%), and West Virginia (2.2%).
The changes reflect the 2009 program revisions made to adhere to the 2005 Dietary Guidelines for Americans and the infant food and feeding practice guidelines of the American Academy of Pediatrics, Dr. Pan and associates wrote.
“The revised food packages include a broader range of healthy food options; promote fruit, vegetable, and whole wheat product purchases; support breastfeeding; and give WIC state and territory agencies more flexibility to accommodate cultural food preferences,” the authors noted.
In response to the changes, Dr. Pan and associates noted, authorized WIC stores began carrying healthier offerings. Tracking showed that children in the program consumed more fruits, vegetables, and whole grain products and less juice, white bread, and whole milk after the revisions than they did previously.
Despite the good news, childhood obesity rates still are too high and much remains to be done, they noted.
“Multiple approaches are needed to address and eliminate childhood obesity. The National Academy of Medicine and other groups have recommended a comprehensive and integrated approach that calls for positive changes in physical activity and food and beverage environments in multiple settings including home, early care and education [such as nutrition standards for food served], and community [such as neighborhood designs that encourage walking and biking] to promote healthy eating and physical activity for young children. Further implementation of these positive changes across the United States could further the decreases in child-hood obesity,” Dr. Pan and coauthors concluded.
Dr. Pan and coauthors had no financial disclosures.
SOURCE: Pan L et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 22;68(46):1057-61.
FROM THE MORBIDITY AND MORTALITY WEEKLY REPORT
Managing pain in kids during minor procedures: A tricky balance
NEW ORLEANS – Baruch S. Krauss, MD, EdM said at the annual meeting of the American Academy of Pediatrics.
Dr. Krauss, a pediatric emergency physician at Boston Children’s Hospital, shared tips for producing a positive experience when children present for minor procedures such as an intravenous catheter insertion or a laceration repair.
Control the environment
Setting the stage for a positive experience for children and their parents involves decreasing sensory stimuli by minimizing noise and bustle, the number of people in the room, and the reminder cues. “Even if you have trust with the child, there are certain things that could trigger the child to become fearful and anxious,” said Dr. Krauss, who also holds an academic post in the department of pediatrics at Harvard Medical School, Boston. “You want to make sure that medical equipment or a syringe is covered – anything that would remind the child or trigger the child to be more concerned and anxious.”
He recommends careful use of lighting, particularly in children who present with a head laceration or a facial laceration. “You may need to put a light near the wound, but that may be fearful for the child,” said Dr. Krauss, who coauthored a recent article on the topic that contains links to instructional videos (Ann Emerg Med 2019;74[1]:30-5). “Read the cues of the child,” he said. One desensitization technique he uses in such cases is to tell the child a story about the sun. He then goes on to liken the warmth of the exam light to the warmth of the sun.
Limiting the number of clinicians who speak to the child during the procedure also is key. “One person should speak to the child,” he advised. “Otherwise, it creates confusion for the child and it is hard for them to focus their attention. What you really want is to be able to control the child’s attention. You want to be able to capture their attention.”
It’s also important to keep medical equipment out of view. “I can’t tell you how many times I’ve seen consultants come in and a child needs to have a laceration repair, and they’re filling the syringe with lidocaine in front of the child,” Dr. Krauss said. “You want to avoid that. You also want to work outside of the child’s visual field if you can. Positioning is critical. I will try whatever position works for the child and the family.” This may including asking the parent to hold and swaddle an infant during the procedure, or positioning young children in the parent’s lap with their arm secured.
“Two things that upset kids during laceration repair are water dripping into their eyes during irrigation and the suture falling across their face as you’re stitching,” he added. “You want to develop your procedural skills so you can avoid that happening.”
Tailor the approach to the individual child
Some children will want to watch what you’re doing, but normally Dr. Krauss uses towels or blankets to cover the area being worked on. “If the child is part of your practice and you know his temperament and coping style, that makes it a lot easier; you know how to approach him,” he said. “They can trust you but they still can be quite fearful.” Sometimes, the child is relaxed but the parent becomes anxious. That anxiety can be transmitted to child. “If I see that the parents are anxious, I work directly with the child, and not the parent,” he said. “There’s not much I can tell a parent verbally that’s going to change their anxiety or fear level. But, as soon I start moving the child’s emotional state from fear to trust, the parent senses that and they relax, and that gets transmitted back to the child.”
Use age-appropriate language
When treating infants and children, Dr. Krauss often uses “parentese,” a simplified way that parents use to talk to young children. “It’s clearer, simpler, more attention-maintaining, and has longer pauses,” he said. “That can be very comforting to children.” Content and phrasing become important in older children. “You want to avoid the nocebo effect,” he continued. “If you tell a child, ‘This is really going to sting or hurt,’ you’re tipping the scales toward them having that experience.”
In an article about behavioral approaches to anxiety and pain management for pediatric venous access, Lindsey L. Cohen, PhD, devised a list of suggested phrasing to use. For example, instead of saying “You will be fine; there is nothing to worry about,” ask, “What did you do in school today?” as a form of distraction. Instead of saying, “It will feel like a bee sting,” ask, “Tell me how it feels.” And instead of saying, “Don’t cry,” say, “That was hard; I am proud of you” (Pediatrics 2008;122[suppl 3]:S134-9).
In a more recent article, Dr. Krauss and colleagues discussed current concepts of managing pain in children who present to the emergency department (Lancet 2016;387:83-92). Among distracting activities to try with infants and preschoolers are blowing bubbles, the use of a lighted wand, sound, music, or books, they noted. Distracting activities to try with preschoolers and in older children include art activities such as drawing, coloring, and the use of play dough, and computer games.
Clinicians also can ask the child to engage in a developmental task as a form of distraction. Dr. Krauss recalled a 22-month-old boy who presented to the emergency department with a forehead laceration. Mindful that the boy was developing eye-hand coordination and fine motor activity, Dr. Krauss offered him a coloring book that contained a picture of a clown, and instructed him to color the clown’s eyes red while Dr. Krauss tended to the wound. “His attention was completely fixed on that learning task,” he said.
Dr. Krauss reported having no financial disclosures.
NEW ORLEANS – Baruch S. Krauss, MD, EdM said at the annual meeting of the American Academy of Pediatrics.
Dr. Krauss, a pediatric emergency physician at Boston Children’s Hospital, shared tips for producing a positive experience when children present for minor procedures such as an intravenous catheter insertion or a laceration repair.
Control the environment
Setting the stage for a positive experience for children and their parents involves decreasing sensory stimuli by minimizing noise and bustle, the number of people in the room, and the reminder cues. “Even if you have trust with the child, there are certain things that could trigger the child to become fearful and anxious,” said Dr. Krauss, who also holds an academic post in the department of pediatrics at Harvard Medical School, Boston. “You want to make sure that medical equipment or a syringe is covered – anything that would remind the child or trigger the child to be more concerned and anxious.”
He recommends careful use of lighting, particularly in children who present with a head laceration or a facial laceration. “You may need to put a light near the wound, but that may be fearful for the child,” said Dr. Krauss, who coauthored a recent article on the topic that contains links to instructional videos (Ann Emerg Med 2019;74[1]:30-5). “Read the cues of the child,” he said. One desensitization technique he uses in such cases is to tell the child a story about the sun. He then goes on to liken the warmth of the exam light to the warmth of the sun.
Limiting the number of clinicians who speak to the child during the procedure also is key. “One person should speak to the child,” he advised. “Otherwise, it creates confusion for the child and it is hard for them to focus their attention. What you really want is to be able to control the child’s attention. You want to be able to capture their attention.”
It’s also important to keep medical equipment out of view. “I can’t tell you how many times I’ve seen consultants come in and a child needs to have a laceration repair, and they’re filling the syringe with lidocaine in front of the child,” Dr. Krauss said. “You want to avoid that. You also want to work outside of the child’s visual field if you can. Positioning is critical. I will try whatever position works for the child and the family.” This may including asking the parent to hold and swaddle an infant during the procedure, or positioning young children in the parent’s lap with their arm secured.
“Two things that upset kids during laceration repair are water dripping into their eyes during irrigation and the suture falling across their face as you’re stitching,” he added. “You want to develop your procedural skills so you can avoid that happening.”
Tailor the approach to the individual child
Some children will want to watch what you’re doing, but normally Dr. Krauss uses towels or blankets to cover the area being worked on. “If the child is part of your practice and you know his temperament and coping style, that makes it a lot easier; you know how to approach him,” he said. “They can trust you but they still can be quite fearful.” Sometimes, the child is relaxed but the parent becomes anxious. That anxiety can be transmitted to child. “If I see that the parents are anxious, I work directly with the child, and not the parent,” he said. “There’s not much I can tell a parent verbally that’s going to change their anxiety or fear level. But, as soon I start moving the child’s emotional state from fear to trust, the parent senses that and they relax, and that gets transmitted back to the child.”
Use age-appropriate language
When treating infants and children, Dr. Krauss often uses “parentese,” a simplified way that parents use to talk to young children. “It’s clearer, simpler, more attention-maintaining, and has longer pauses,” he said. “That can be very comforting to children.” Content and phrasing become important in older children. “You want to avoid the nocebo effect,” he continued. “If you tell a child, ‘This is really going to sting or hurt,’ you’re tipping the scales toward them having that experience.”
In an article about behavioral approaches to anxiety and pain management for pediatric venous access, Lindsey L. Cohen, PhD, devised a list of suggested phrasing to use. For example, instead of saying “You will be fine; there is nothing to worry about,” ask, “What did you do in school today?” as a form of distraction. Instead of saying, “It will feel like a bee sting,” ask, “Tell me how it feels.” And instead of saying, “Don’t cry,” say, “That was hard; I am proud of you” (Pediatrics 2008;122[suppl 3]:S134-9).
In a more recent article, Dr. Krauss and colleagues discussed current concepts of managing pain in children who present to the emergency department (Lancet 2016;387:83-92). Among distracting activities to try with infants and preschoolers are blowing bubbles, the use of a lighted wand, sound, music, or books, they noted. Distracting activities to try with preschoolers and in older children include art activities such as drawing, coloring, and the use of play dough, and computer games.
Clinicians also can ask the child to engage in a developmental task as a form of distraction. Dr. Krauss recalled a 22-month-old boy who presented to the emergency department with a forehead laceration. Mindful that the boy was developing eye-hand coordination and fine motor activity, Dr. Krauss offered him a coloring book that contained a picture of a clown, and instructed him to color the clown’s eyes red while Dr. Krauss tended to the wound. “His attention was completely fixed on that learning task,” he said.
Dr. Krauss reported having no financial disclosures.
NEW ORLEANS – Baruch S. Krauss, MD, EdM said at the annual meeting of the American Academy of Pediatrics.
Dr. Krauss, a pediatric emergency physician at Boston Children’s Hospital, shared tips for producing a positive experience when children present for minor procedures such as an intravenous catheter insertion or a laceration repair.
Control the environment
Setting the stage for a positive experience for children and their parents involves decreasing sensory stimuli by minimizing noise and bustle, the number of people in the room, and the reminder cues. “Even if you have trust with the child, there are certain things that could trigger the child to become fearful and anxious,” said Dr. Krauss, who also holds an academic post in the department of pediatrics at Harvard Medical School, Boston. “You want to make sure that medical equipment or a syringe is covered – anything that would remind the child or trigger the child to be more concerned and anxious.”
He recommends careful use of lighting, particularly in children who present with a head laceration or a facial laceration. “You may need to put a light near the wound, but that may be fearful for the child,” said Dr. Krauss, who coauthored a recent article on the topic that contains links to instructional videos (Ann Emerg Med 2019;74[1]:30-5). “Read the cues of the child,” he said. One desensitization technique he uses in such cases is to tell the child a story about the sun. He then goes on to liken the warmth of the exam light to the warmth of the sun.
Limiting the number of clinicians who speak to the child during the procedure also is key. “One person should speak to the child,” he advised. “Otherwise, it creates confusion for the child and it is hard for them to focus their attention. What you really want is to be able to control the child’s attention. You want to be able to capture their attention.”
It’s also important to keep medical equipment out of view. “I can’t tell you how many times I’ve seen consultants come in and a child needs to have a laceration repair, and they’re filling the syringe with lidocaine in front of the child,” Dr. Krauss said. “You want to avoid that. You also want to work outside of the child’s visual field if you can. Positioning is critical. I will try whatever position works for the child and the family.” This may including asking the parent to hold and swaddle an infant during the procedure, or positioning young children in the parent’s lap with their arm secured.
“Two things that upset kids during laceration repair are water dripping into their eyes during irrigation and the suture falling across their face as you’re stitching,” he added. “You want to develop your procedural skills so you can avoid that happening.”
Tailor the approach to the individual child
Some children will want to watch what you’re doing, but normally Dr. Krauss uses towels or blankets to cover the area being worked on. “If the child is part of your practice and you know his temperament and coping style, that makes it a lot easier; you know how to approach him,” he said. “They can trust you but they still can be quite fearful.” Sometimes, the child is relaxed but the parent becomes anxious. That anxiety can be transmitted to child. “If I see that the parents are anxious, I work directly with the child, and not the parent,” he said. “There’s not much I can tell a parent verbally that’s going to change their anxiety or fear level. But, as soon I start moving the child’s emotional state from fear to trust, the parent senses that and they relax, and that gets transmitted back to the child.”
Use age-appropriate language
When treating infants and children, Dr. Krauss often uses “parentese,” a simplified way that parents use to talk to young children. “It’s clearer, simpler, more attention-maintaining, and has longer pauses,” he said. “That can be very comforting to children.” Content and phrasing become important in older children. “You want to avoid the nocebo effect,” he continued. “If you tell a child, ‘This is really going to sting or hurt,’ you’re tipping the scales toward them having that experience.”
In an article about behavioral approaches to anxiety and pain management for pediatric venous access, Lindsey L. Cohen, PhD, devised a list of suggested phrasing to use. For example, instead of saying “You will be fine; there is nothing to worry about,” ask, “What did you do in school today?” as a form of distraction. Instead of saying, “It will feel like a bee sting,” ask, “Tell me how it feels.” And instead of saying, “Don’t cry,” say, “That was hard; I am proud of you” (Pediatrics 2008;122[suppl 3]:S134-9).
In a more recent article, Dr. Krauss and colleagues discussed current concepts of managing pain in children who present to the emergency department (Lancet 2016;387:83-92). Among distracting activities to try with infants and preschoolers are blowing bubbles, the use of a lighted wand, sound, music, or books, they noted. Distracting activities to try with preschoolers and in older children include art activities such as drawing, coloring, and the use of play dough, and computer games.
Clinicians also can ask the child to engage in a developmental task as a form of distraction. Dr. Krauss recalled a 22-month-old boy who presented to the emergency department with a forehead laceration. Mindful that the boy was developing eye-hand coordination and fine motor activity, Dr. Krauss offered him a coloring book that contained a picture of a clown, and instructed him to color the clown’s eyes red while Dr. Krauss tended to the wound. “His attention was completely fixed on that learning task,” he said.
Dr. Krauss reported having no financial disclosures.
EXPERT ANALYSIS AT AAP 19
Anticipating the A.I. revolution
Goal is to augment human performance
Artificial intelligence (A.I.) is likely to change almost everything in medical practice, according to a new book called “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again,” by Eric Topol, MD.
Dr. Topol told The Hospitalist that his book’s subtitle “is the paradox: the unexpected, far-reaching goal of A.I. that can, if used properly, restore the most important part of medicine – a deep patient-doctor relationship.”
That’s because A.I. can do more than enhance diagnoses; it can also help with tasks such as note-taking and reading scans, making it possible for hospitalists to spend more time connecting with their patients. “Hospitalists could have a much better handle on a patient’s dataset via algorithmic processing, providing alerts and augmented performance of hospitalists (when validated),” Dr. Topol said. “They can also expect far less keyboard use with the help of speech recognition, natural language processing, and deep learning.”In an interview with the New York Times, Dr. Topol said that by augmenting human performance, A.I. has the potential to markedly improve productivity, efficiency, work flow, accuracy and speed, both for doctors and for patients, giving more charge and control to consumers through algorithmic support of their data.
“We can’t, and will never, rely on only algorithms for interpretation of life and death matters,” he said. “That requires human expert contextualization, something machines can’t do.”Of course, there could be pitfalls. “The liabilities include breaches of privacy and security, hacking, the lack of explainability of most A.I. algorithms, the potential to worsen inequities, the embedded bias, and ethical quandaries,” he said.
Reference
1. O’Connor A. How Artificial Intelligence Could Transform Medicine. New York Times. March 11, 2019. https://www.nytimes.com/2019/03/11/well/live/how-artificial-intelligence-could-transform-medicine.html.
Goal is to augment human performance
Goal is to augment human performance
Artificial intelligence (A.I.) is likely to change almost everything in medical practice, according to a new book called “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again,” by Eric Topol, MD.
Dr. Topol told The Hospitalist that his book’s subtitle “is the paradox: the unexpected, far-reaching goal of A.I. that can, if used properly, restore the most important part of medicine – a deep patient-doctor relationship.”
That’s because A.I. can do more than enhance diagnoses; it can also help with tasks such as note-taking and reading scans, making it possible for hospitalists to spend more time connecting with their patients. “Hospitalists could have a much better handle on a patient’s dataset via algorithmic processing, providing alerts and augmented performance of hospitalists (when validated),” Dr. Topol said. “They can also expect far less keyboard use with the help of speech recognition, natural language processing, and deep learning.”In an interview with the New York Times, Dr. Topol said that by augmenting human performance, A.I. has the potential to markedly improve productivity, efficiency, work flow, accuracy and speed, both for doctors and for patients, giving more charge and control to consumers through algorithmic support of their data.
“We can’t, and will never, rely on only algorithms for interpretation of life and death matters,” he said. “That requires human expert contextualization, something machines can’t do.”Of course, there could be pitfalls. “The liabilities include breaches of privacy and security, hacking, the lack of explainability of most A.I. algorithms, the potential to worsen inequities, the embedded bias, and ethical quandaries,” he said.
Reference
1. O’Connor A. How Artificial Intelligence Could Transform Medicine. New York Times. March 11, 2019. https://www.nytimes.com/2019/03/11/well/live/how-artificial-intelligence-could-transform-medicine.html.
Artificial intelligence (A.I.) is likely to change almost everything in medical practice, according to a new book called “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again,” by Eric Topol, MD.
Dr. Topol told The Hospitalist that his book’s subtitle “is the paradox: the unexpected, far-reaching goal of A.I. that can, if used properly, restore the most important part of medicine – a deep patient-doctor relationship.”
That’s because A.I. can do more than enhance diagnoses; it can also help with tasks such as note-taking and reading scans, making it possible for hospitalists to spend more time connecting with their patients. “Hospitalists could have a much better handle on a patient’s dataset via algorithmic processing, providing alerts and augmented performance of hospitalists (when validated),” Dr. Topol said. “They can also expect far less keyboard use with the help of speech recognition, natural language processing, and deep learning.”In an interview with the New York Times, Dr. Topol said that by augmenting human performance, A.I. has the potential to markedly improve productivity, efficiency, work flow, accuracy and speed, both for doctors and for patients, giving more charge and control to consumers through algorithmic support of their data.
“We can’t, and will never, rely on only algorithms for interpretation of life and death matters,” he said. “That requires human expert contextualization, something machines can’t do.”Of course, there could be pitfalls. “The liabilities include breaches of privacy and security, hacking, the lack of explainability of most A.I. algorithms, the potential to worsen inequities, the embedded bias, and ethical quandaries,” he said.
Reference
1. O’Connor A. How Artificial Intelligence Could Transform Medicine. New York Times. March 11, 2019. https://www.nytimes.com/2019/03/11/well/live/how-artificial-intelligence-could-transform-medicine.html.
How should we monitor for ovarian cancer recurrence?
Several practice-changing developments in the treatment of ovarian cancer were seen in 2019, including the results of the pivotal trial Gynecologic Oncology Group (GOG)-213, which were published in November in the New England Journal of Medicine.1 This trial randomly assigned women with ovarian cancer who had achieved a remission of more than 6 months after primary therapy (“platinum sensitive”) to either a repeat surgical cytoreduction followed by chemotherapy versus chemotherapy alone. It found that the addition of surgery provided no benefit in overall survival, challenging the notion that repeat surgical “debulking” should be routinely considered for the treatment of women with platinum-sensitive ovarian cancer.
The primary treatment of ovarian cancer includes a combination of surgery and chemotherapy, after which the vast majority of patients will experience a complete clinical response, a so-called “remission.” At that time patients enter surveillance care, in which their providers evaluate them, typically every 3 months in the first 2-3 years. These visits are designed to address ongoing toxicities of therapy in addition to evaluation for recurrence. At these visits, it is common for providers to assess tumor markers, such as CA 125 (cancer antigen 125), if they had been elevated at original diagnosis. As a gynecologic oncologist, I can vouch for the fact that patients “sweat” on this lab result the most. No matter how reassuring my physical exams or their symptom profiles are, there is nothing more comforting as a normal, stable CA 125 value in black and white. However, and may, in fact, be harmful.
Providers have drawn tumor markers at surveillance exams under the working premise that abnormal or rising values signal the onset of asymptomatic recurrence, and that earlier treatment will be associated with better responses to salvage therapy. However, this has not been shown to be the case in randomized, controlled trials. In a large European cooperative-group trial, more than 500 patients with a history of completely treated ovarian cancer were randomized to either reinitiation of chemotherapy (salvage therapy) when CA 125 values first doubled or to reinitiation of therapy when they became symptomatic without knowledge of their CA 125 values.2 In this trial the mean survival of both groups was the same (26 months for the early initiation of chemotherapy vs. 27 for late initiation). However, what did differ were the quality of life scores, which were lower for the group who initiated chemotherapy earlier, likely because they received toxic therapies for longer periods of time.
The results of this trial were challenged by those who felt that this study did not evaluate the role that surgery might play. Their argument was that surgery in the recurrent setting would improve the outcomes from chemotherapy for certain patients with long platinum-free intervals (duration of remission since last receiving a platinum-containing drug), oligometastatic disease, and good performance status, just as it had in the primary setting. Retrospective series seemed to confirm this phenomenon, particularly if surgeons were able to achieve a complete resection (no residual measurable disease).3,4 By detecting asymptomatic patients with early elevations in CA 125, they proposed they might identify patients with lower disease burden in whom complete debulking would be more feasible. Whereas, in waiting for symptoms alone, they might “miss the boat,” and discover recurrence when it was too advanced to be completely resected.
The results of the GOG-213 study significantly challenge this line of thought, although with some caveats. Because this new trial showed no survival benefit for women with secondary debulking prior to chemotherapy, one could question whether there is any benefit in screening for asymptomatic, early recurrence. The authors of the study looked in subgroup analyses to attempt to identify groups who might benefit over others, such as women who had complete surgical cytoreduction (no residual disease) but still did not find a benefit to surgery. The trial population as a whole included women who had very favorable prognostic factors, including very long disease-free intervals (median, 20.4 months), and most women had only one or two sites of measurable recurrence. Yet it is remarkable that, in this group of patients who were predisposed to optimal outcomes, no benefit from surgery was observed.
However, it is important to recognize that the equivalent results of single-modality chemotherapy were achieved with the majority of women receiving bevacizumab with their chemotherapy regimen. An additional consideration is that the chemotherapy for platinum-sensitive, recurrent ovarian cancer has changed in recent years as we have learned the benefit of poly (ADP-ribose) polymerase (PARP) inhibitor drugs as maintenance therapy following complete or partial response to chemotherapy.5 It is unclear how the addition of PARP inhibitor maintenance therapy might have influenced the results of GOG-213. Further advancements in targeted therapies and consideration of hyperthermic intraperitoneal chemotherapy at the time of surgery also are being developed, and so, the answer of optimal therapy for platinum-sensitive ovarian cancer is a fluid one and might include a role for surgery for some of these patients.
However, in the meantime, before routinely ordering that tumor marker assessment in the surveillance period, it is important to remember that, if secondary cytoreduction is not beneficial and early initiation of chemotherapy is not helpful either, then these tumor marker results might provide more hindrance than help. Why search for recurrence at an earlier time point with CA 125 elevations if there isn’t a benefit to the patient in doing so? There certainly appears to be worse quality of life in doing so, and most likely also additional cost. Perhaps we should wait for clinical symptoms to confirm recurrence?
In the meantime, we will continue to have discussions with patients after primary therapy regarding how to best monitor them in the surveillance period. We will educate them about the limitations of early initiation of chemotherapy and the potentially limited role for surgery. Hopefully with individualized care and shared decision making, patients can guide us as to how they best be evaluated. While receiving a normal CA 125 result is powerfully reassuring, it is just as powerfully confusing and difficult for a patient to receive an abnormal one followed by a period of “doing nothing,” otherwise known as expectant management, if immediate treatment is not beneficial.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at obnews@mdedge.com.
References
1. N Engl J Med. 2019 Nov 14;381(20):1929-39.
2. Lancet. 2010 Oct 2;376(9747):1155-63.
3. Gynecol Oncol. 2009 Jan;112(1):265-74.
4. Br J Cancer. 2011 Sep 27;105(7):890-6.
5. N Engl J Med. 2016 Dec 1;375(22):2154-64.
Several practice-changing developments in the treatment of ovarian cancer were seen in 2019, including the results of the pivotal trial Gynecologic Oncology Group (GOG)-213, which were published in November in the New England Journal of Medicine.1 This trial randomly assigned women with ovarian cancer who had achieved a remission of more than 6 months after primary therapy (“platinum sensitive”) to either a repeat surgical cytoreduction followed by chemotherapy versus chemotherapy alone. It found that the addition of surgery provided no benefit in overall survival, challenging the notion that repeat surgical “debulking” should be routinely considered for the treatment of women with platinum-sensitive ovarian cancer.
The primary treatment of ovarian cancer includes a combination of surgery and chemotherapy, after which the vast majority of patients will experience a complete clinical response, a so-called “remission.” At that time patients enter surveillance care, in which their providers evaluate them, typically every 3 months in the first 2-3 years. These visits are designed to address ongoing toxicities of therapy in addition to evaluation for recurrence. At these visits, it is common for providers to assess tumor markers, such as CA 125 (cancer antigen 125), if they had been elevated at original diagnosis. As a gynecologic oncologist, I can vouch for the fact that patients “sweat” on this lab result the most. No matter how reassuring my physical exams or their symptom profiles are, there is nothing more comforting as a normal, stable CA 125 value in black and white. However, and may, in fact, be harmful.
Providers have drawn tumor markers at surveillance exams under the working premise that abnormal or rising values signal the onset of asymptomatic recurrence, and that earlier treatment will be associated with better responses to salvage therapy. However, this has not been shown to be the case in randomized, controlled trials. In a large European cooperative-group trial, more than 500 patients with a history of completely treated ovarian cancer were randomized to either reinitiation of chemotherapy (salvage therapy) when CA 125 values first doubled or to reinitiation of therapy when they became symptomatic without knowledge of their CA 125 values.2 In this trial the mean survival of both groups was the same (26 months for the early initiation of chemotherapy vs. 27 for late initiation). However, what did differ were the quality of life scores, which were lower for the group who initiated chemotherapy earlier, likely because they received toxic therapies for longer periods of time.
The results of this trial were challenged by those who felt that this study did not evaluate the role that surgery might play. Their argument was that surgery in the recurrent setting would improve the outcomes from chemotherapy for certain patients with long platinum-free intervals (duration of remission since last receiving a platinum-containing drug), oligometastatic disease, and good performance status, just as it had in the primary setting. Retrospective series seemed to confirm this phenomenon, particularly if surgeons were able to achieve a complete resection (no residual measurable disease).3,4 By detecting asymptomatic patients with early elevations in CA 125, they proposed they might identify patients with lower disease burden in whom complete debulking would be more feasible. Whereas, in waiting for symptoms alone, they might “miss the boat,” and discover recurrence when it was too advanced to be completely resected.
The results of the GOG-213 study significantly challenge this line of thought, although with some caveats. Because this new trial showed no survival benefit for women with secondary debulking prior to chemotherapy, one could question whether there is any benefit in screening for asymptomatic, early recurrence. The authors of the study looked in subgroup analyses to attempt to identify groups who might benefit over others, such as women who had complete surgical cytoreduction (no residual disease) but still did not find a benefit to surgery. The trial population as a whole included women who had very favorable prognostic factors, including very long disease-free intervals (median, 20.4 months), and most women had only one or two sites of measurable recurrence. Yet it is remarkable that, in this group of patients who were predisposed to optimal outcomes, no benefit from surgery was observed.
However, it is important to recognize that the equivalent results of single-modality chemotherapy were achieved with the majority of women receiving bevacizumab with their chemotherapy regimen. An additional consideration is that the chemotherapy for platinum-sensitive, recurrent ovarian cancer has changed in recent years as we have learned the benefit of poly (ADP-ribose) polymerase (PARP) inhibitor drugs as maintenance therapy following complete or partial response to chemotherapy.5 It is unclear how the addition of PARP inhibitor maintenance therapy might have influenced the results of GOG-213. Further advancements in targeted therapies and consideration of hyperthermic intraperitoneal chemotherapy at the time of surgery also are being developed, and so, the answer of optimal therapy for platinum-sensitive ovarian cancer is a fluid one and might include a role for surgery for some of these patients.
However, in the meantime, before routinely ordering that tumor marker assessment in the surveillance period, it is important to remember that, if secondary cytoreduction is not beneficial and early initiation of chemotherapy is not helpful either, then these tumor marker results might provide more hindrance than help. Why search for recurrence at an earlier time point with CA 125 elevations if there isn’t a benefit to the patient in doing so? There certainly appears to be worse quality of life in doing so, and most likely also additional cost. Perhaps we should wait for clinical symptoms to confirm recurrence?
In the meantime, we will continue to have discussions with patients after primary therapy regarding how to best monitor them in the surveillance period. We will educate them about the limitations of early initiation of chemotherapy and the potentially limited role for surgery. Hopefully with individualized care and shared decision making, patients can guide us as to how they best be evaluated. While receiving a normal CA 125 result is powerfully reassuring, it is just as powerfully confusing and difficult for a patient to receive an abnormal one followed by a period of “doing nothing,” otherwise known as expectant management, if immediate treatment is not beneficial.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at obnews@mdedge.com.
References
1. N Engl J Med. 2019 Nov 14;381(20):1929-39.
2. Lancet. 2010 Oct 2;376(9747):1155-63.
3. Gynecol Oncol. 2009 Jan;112(1):265-74.
4. Br J Cancer. 2011 Sep 27;105(7):890-6.
5. N Engl J Med. 2016 Dec 1;375(22):2154-64.
Several practice-changing developments in the treatment of ovarian cancer were seen in 2019, including the results of the pivotal trial Gynecologic Oncology Group (GOG)-213, which were published in November in the New England Journal of Medicine.1 This trial randomly assigned women with ovarian cancer who had achieved a remission of more than 6 months after primary therapy (“platinum sensitive”) to either a repeat surgical cytoreduction followed by chemotherapy versus chemotherapy alone. It found that the addition of surgery provided no benefit in overall survival, challenging the notion that repeat surgical “debulking” should be routinely considered for the treatment of women with platinum-sensitive ovarian cancer.
The primary treatment of ovarian cancer includes a combination of surgery and chemotherapy, after which the vast majority of patients will experience a complete clinical response, a so-called “remission.” At that time patients enter surveillance care, in which their providers evaluate them, typically every 3 months in the first 2-3 years. These visits are designed to address ongoing toxicities of therapy in addition to evaluation for recurrence. At these visits, it is common for providers to assess tumor markers, such as CA 125 (cancer antigen 125), if they had been elevated at original diagnosis. As a gynecologic oncologist, I can vouch for the fact that patients “sweat” on this lab result the most. No matter how reassuring my physical exams or their symptom profiles are, there is nothing more comforting as a normal, stable CA 125 value in black and white. However, and may, in fact, be harmful.
Providers have drawn tumor markers at surveillance exams under the working premise that abnormal or rising values signal the onset of asymptomatic recurrence, and that earlier treatment will be associated with better responses to salvage therapy. However, this has not been shown to be the case in randomized, controlled trials. In a large European cooperative-group trial, more than 500 patients with a history of completely treated ovarian cancer were randomized to either reinitiation of chemotherapy (salvage therapy) when CA 125 values first doubled or to reinitiation of therapy when they became symptomatic without knowledge of their CA 125 values.2 In this trial the mean survival of both groups was the same (26 months for the early initiation of chemotherapy vs. 27 for late initiation). However, what did differ were the quality of life scores, which were lower for the group who initiated chemotherapy earlier, likely because they received toxic therapies for longer periods of time.
The results of this trial were challenged by those who felt that this study did not evaluate the role that surgery might play. Their argument was that surgery in the recurrent setting would improve the outcomes from chemotherapy for certain patients with long platinum-free intervals (duration of remission since last receiving a platinum-containing drug), oligometastatic disease, and good performance status, just as it had in the primary setting. Retrospective series seemed to confirm this phenomenon, particularly if surgeons were able to achieve a complete resection (no residual measurable disease).3,4 By detecting asymptomatic patients with early elevations in CA 125, they proposed they might identify patients with lower disease burden in whom complete debulking would be more feasible. Whereas, in waiting for symptoms alone, they might “miss the boat,” and discover recurrence when it was too advanced to be completely resected.
The results of the GOG-213 study significantly challenge this line of thought, although with some caveats. Because this new trial showed no survival benefit for women with secondary debulking prior to chemotherapy, one could question whether there is any benefit in screening for asymptomatic, early recurrence. The authors of the study looked in subgroup analyses to attempt to identify groups who might benefit over others, such as women who had complete surgical cytoreduction (no residual disease) but still did not find a benefit to surgery. The trial population as a whole included women who had very favorable prognostic factors, including very long disease-free intervals (median, 20.4 months), and most women had only one or two sites of measurable recurrence. Yet it is remarkable that, in this group of patients who were predisposed to optimal outcomes, no benefit from surgery was observed.
However, it is important to recognize that the equivalent results of single-modality chemotherapy were achieved with the majority of women receiving bevacizumab with their chemotherapy regimen. An additional consideration is that the chemotherapy for platinum-sensitive, recurrent ovarian cancer has changed in recent years as we have learned the benefit of poly (ADP-ribose) polymerase (PARP) inhibitor drugs as maintenance therapy following complete or partial response to chemotherapy.5 It is unclear how the addition of PARP inhibitor maintenance therapy might have influenced the results of GOG-213. Further advancements in targeted therapies and consideration of hyperthermic intraperitoneal chemotherapy at the time of surgery also are being developed, and so, the answer of optimal therapy for platinum-sensitive ovarian cancer is a fluid one and might include a role for surgery for some of these patients.
However, in the meantime, before routinely ordering that tumor marker assessment in the surveillance period, it is important to remember that, if secondary cytoreduction is not beneficial and early initiation of chemotherapy is not helpful either, then these tumor marker results might provide more hindrance than help. Why search for recurrence at an earlier time point with CA 125 elevations if there isn’t a benefit to the patient in doing so? There certainly appears to be worse quality of life in doing so, and most likely also additional cost. Perhaps we should wait for clinical symptoms to confirm recurrence?
In the meantime, we will continue to have discussions with patients after primary therapy regarding how to best monitor them in the surveillance period. We will educate them about the limitations of early initiation of chemotherapy and the potentially limited role for surgery. Hopefully with individualized care and shared decision making, patients can guide us as to how they best be evaluated. While receiving a normal CA 125 result is powerfully reassuring, it is just as powerfully confusing and difficult for a patient to receive an abnormal one followed by a period of “doing nothing,” otherwise known as expectant management, if immediate treatment is not beneficial.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at obnews@mdedge.com.
References
1. N Engl J Med. 2019 Nov 14;381(20):1929-39.
2. Lancet. 2010 Oct 2;376(9747):1155-63.
3. Gynecol Oncol. 2009 Jan;112(1):265-74.
4. Br J Cancer. 2011 Sep 27;105(7):890-6.
5. N Engl J Med. 2016 Dec 1;375(22):2154-64.
Inexperience is the main cause of unsafe driving among teens
NEW ORLEANS – Teens need to drive for a wide range of reasons, from going to and from school or work to overall mobility, but driving still is the most dangerous thing teenagers do, according to Brian Johnston, MD, MPH, professor of pediatrics at the University of Washington in Seattle.
Motor vehicle traffic accidents continue to be the leading cause of death of adolescents aged 15-19 years, according to 2017 data from the National Center for Health Statistics at the Centers for the Disease Control and Prevention.
“Inexperience drives the statistics we see,” Dr. Johnston said at the annual meeting of the American Academy of Pediatrics. “There is a steep learning curve among drivers of all ages, and crash rates are highest during the first few months after teens begin driving without supervision.”
Although the risk of accidents is higher than average for any new driver, it’s disproportionately higher for younger teens, compared with other ages: 16-year-old novice drivers have a higher accident risk than that of 17-year-olds, whose risk is similar to that of 18- and 19-year-old novices.
How long drivers have been licensed has a far bigger impact on crash risk, Dr. Johnston said (Traffic Inj. Prev. 2009 Jun;10[3]:209-19).
But the risk of an accident also increases with each additional passenger a teen driver has, particularly for younger and male drivers (Traffic Inj Prev. 2013;14[3]:283-92). More passengers likely means more distraction, and distraction, driving too fast for road conditions, and not scanning the roadway are the three most common errors – together accounting for about half of all teen drivers’ crashes.
Risk factors for accidents
Speed is a contributing factor in just over a third (36%) of teens’ fatal crashes. Adolescents drive faster and keep shorter following distances than adults do. But as with adults, wearing seat belts substantially reduces the risk of death in accidents.
Nationally, 90% of drivers use seat belts, with higher rates in states with primary enforcement (92%) than those in states with secondary enforcement (83%).
But barely more than half (54%) of U.S. high school students say they “always” wear a seat belt, and just under half of teens (47%) who died in crashes in 2017 weren’t wearing one. As seen in adults, teens are more likely to buckle up, by 12%, in states with primary seat belt laws.
Distraction during driving can be visual, manual, or cognitive – and handheld electronic devices such as smartphones cause all three distraction types. Cell phones nearly double the proportion of teen drivers who die in crashes, from 7% to 13%.
But if teens can keep their eyes on the roadway at all times, even the risks posed by cellphones drop considerably.
“The best evidence shows that secondary tasks only degrade driving performance when they require drivers to look away from the road,” Dr. Johnston said. Looking away for 2 seconds or longer increases crash risk more than fivefold.
Two other risk factors for teen car accidents are drowsiness and nighttime driving. Sleepiness can play a role in crashes at any time of day, and Dr. Johnston noted that some research has associated later high school start times with reduced crash risk.
Teens aged 16-19 years are about four times more likely to have a car accident at night than during the day per each mile driven, the pediatrician noted. Many licensing laws restrict teen driving starting at 11 p.m. or later, but about 50%-60% of their crashes occur between 9 and 11 p.m.
One reason for the increased risk is less experience driving in more difficult conditions, but teens also are more likely to have teen passengers, to be driving excessively fast, or to be under the influence of alcohol at night.
Adolescents’ crash risk is higher than that of adults for any level of blood alcohol content. Self-reported driving after drinking dropped by almost half – from 10% to 5.5% – from 2013 to 2017, but alcohol still is implicated in a substantial number of fatal teen crashes.
As drunk driving has declined, however, driving while under the influence of marijuana has been increasing. According to the National Highway Traffic Safety Administration, case control studies show drivers with tetrahydrocannabinol (THC) in their blood have a 25% increased risk of accidents – but the excess risk associated with THC vanishes when researchers control for age, sex, and concurrent use of alcohol. Not enough research exists to determine what the crash risk would be for adolescent drivers using THC alone.
A less-recognized risk factor for car accidents in teen drivers is ADHD, which increases a teen’s risk of crashing by 36%, particularly in the first month after getting a license, Dr. Johnston said.
ADHD medication appears to mitigate the danger, according to data: Crash risk was 40% lower in adult drivers with ADHD during months they filled their stimulant prescriptions. But one study found only 12% of teens with ADHD filled their prescriptions the month they got their license, and adolescents may not take their medications or still have them in their system on weekends or at night.
Teens recovering from concussion also may have an increased risk. Some evidence suggests driving impairment continues even when other symptoms have resolved, but not enough data exist to determine appropriate criteria for clearing teens to begin driving again.
Interventions to improve teens’ driving safety
Most teens take a basic driver education course before getting their licenses, but no evidence shows that it reduces risk of citations, crashes, or injury. In fact, “skid control training and other kinds of advanced skill training seem to increase crash risk, particularly among young males,” Dr. Johnston said.
What helps teens most is, ironically, more driving.
“If I say inexperience is the single most important risk factor for dying in a crash as a teen, driving experience is the intervention,” he said. More time spent driving – “with supervision in particular, and under diverse conditions,” Dr. Johnston said – increases the repertoire of skills and abilities.
Parents should be encouraged to ride along as their teens drive under diverse road conditions: different roads, different times of the day, and different weather conditions, for example. Parents can narrate their own driving, pointing out hazards and times when they slow down for increased caution, Dr. Johnston said. It might feel “awkward and unnatural,” but “some of the things you as a driver notice all the time are novel to teen drivers.”
Parents can influence road safety for teens in terms of their own behavior and in selecting a safer vehicle. A strong correlation exists between parental texting while driving when children are younger and what they do as teen drivers, for example.
Safer vehicles are bigger, heavier cars with electronic stability control, which reduces risk of death about as much as wearing seat belts. Parents should avoid vehicles with high horsepower and look for cars with the best safety ratings they can afford, Dr. Johnston said.
Several special features in newer cars can help reduce crash risk, such as blind spot detection, automatic breaking, collision avoidance systems, lane departure warning systems, and driver drowsiness detection. Parents may worry that relying on this technology could reduce teens’ learning, but it actually can compensate for skill deficits as they are becoming more skilled drivers.
Parents can look into feedback programs such as smartphone apps or other in-car units that allow parents to see data on teens’ speed, unsafe driving, “near-misses,” and similar driving behaviors. Research has shown that unsafe driving in newly licensed teens dropped by 66% over 4 months of using one of these feedback programs, compared with teens who didn’t use it.
Dr. Johnston also discussed the idea of prelicensure medical exams, similar to physicals that are required before playing sports. These already exist for commercial licenses in most states, but no data exist on whether it’s effective for teens. The goal would be to promote a discussion between parents and their teens about driving: reviewing medications the teen is taking and whether they affect driving; discussing safety of different vehicles; and assessing the teens’ risks, including any cognitive or other medical conditions that could affect driving safety. Even if such a “driving physical” is not currently required, pediatricians can do their own version of one with families.
Dr. Johnston had no disclosures.
NEW ORLEANS – Teens need to drive for a wide range of reasons, from going to and from school or work to overall mobility, but driving still is the most dangerous thing teenagers do, according to Brian Johnston, MD, MPH, professor of pediatrics at the University of Washington in Seattle.
Motor vehicle traffic accidents continue to be the leading cause of death of adolescents aged 15-19 years, according to 2017 data from the National Center for Health Statistics at the Centers for the Disease Control and Prevention.
“Inexperience drives the statistics we see,” Dr. Johnston said at the annual meeting of the American Academy of Pediatrics. “There is a steep learning curve among drivers of all ages, and crash rates are highest during the first few months after teens begin driving without supervision.”
Although the risk of accidents is higher than average for any new driver, it’s disproportionately higher for younger teens, compared with other ages: 16-year-old novice drivers have a higher accident risk than that of 17-year-olds, whose risk is similar to that of 18- and 19-year-old novices.
How long drivers have been licensed has a far bigger impact on crash risk, Dr. Johnston said (Traffic Inj. Prev. 2009 Jun;10[3]:209-19).
But the risk of an accident also increases with each additional passenger a teen driver has, particularly for younger and male drivers (Traffic Inj Prev. 2013;14[3]:283-92). More passengers likely means more distraction, and distraction, driving too fast for road conditions, and not scanning the roadway are the three most common errors – together accounting for about half of all teen drivers’ crashes.
Risk factors for accidents
Speed is a contributing factor in just over a third (36%) of teens’ fatal crashes. Adolescents drive faster and keep shorter following distances than adults do. But as with adults, wearing seat belts substantially reduces the risk of death in accidents.
Nationally, 90% of drivers use seat belts, with higher rates in states with primary enforcement (92%) than those in states with secondary enforcement (83%).
But barely more than half (54%) of U.S. high school students say they “always” wear a seat belt, and just under half of teens (47%) who died in crashes in 2017 weren’t wearing one. As seen in adults, teens are more likely to buckle up, by 12%, in states with primary seat belt laws.
Distraction during driving can be visual, manual, or cognitive – and handheld electronic devices such as smartphones cause all three distraction types. Cell phones nearly double the proportion of teen drivers who die in crashes, from 7% to 13%.
But if teens can keep their eyes on the roadway at all times, even the risks posed by cellphones drop considerably.
“The best evidence shows that secondary tasks only degrade driving performance when they require drivers to look away from the road,” Dr. Johnston said. Looking away for 2 seconds or longer increases crash risk more than fivefold.
Two other risk factors for teen car accidents are drowsiness and nighttime driving. Sleepiness can play a role in crashes at any time of day, and Dr. Johnston noted that some research has associated later high school start times with reduced crash risk.
Teens aged 16-19 years are about four times more likely to have a car accident at night than during the day per each mile driven, the pediatrician noted. Many licensing laws restrict teen driving starting at 11 p.m. or later, but about 50%-60% of their crashes occur between 9 and 11 p.m.
One reason for the increased risk is less experience driving in more difficult conditions, but teens also are more likely to have teen passengers, to be driving excessively fast, or to be under the influence of alcohol at night.
Adolescents’ crash risk is higher than that of adults for any level of blood alcohol content. Self-reported driving after drinking dropped by almost half – from 10% to 5.5% – from 2013 to 2017, but alcohol still is implicated in a substantial number of fatal teen crashes.
As drunk driving has declined, however, driving while under the influence of marijuana has been increasing. According to the National Highway Traffic Safety Administration, case control studies show drivers with tetrahydrocannabinol (THC) in their blood have a 25% increased risk of accidents – but the excess risk associated with THC vanishes when researchers control for age, sex, and concurrent use of alcohol. Not enough research exists to determine what the crash risk would be for adolescent drivers using THC alone.
A less-recognized risk factor for car accidents in teen drivers is ADHD, which increases a teen’s risk of crashing by 36%, particularly in the first month after getting a license, Dr. Johnston said.
ADHD medication appears to mitigate the danger, according to data: Crash risk was 40% lower in adult drivers with ADHD during months they filled their stimulant prescriptions. But one study found only 12% of teens with ADHD filled their prescriptions the month they got their license, and adolescents may not take their medications or still have them in their system on weekends or at night.
Teens recovering from concussion also may have an increased risk. Some evidence suggests driving impairment continues even when other symptoms have resolved, but not enough data exist to determine appropriate criteria for clearing teens to begin driving again.
Interventions to improve teens’ driving safety
Most teens take a basic driver education course before getting their licenses, but no evidence shows that it reduces risk of citations, crashes, or injury. In fact, “skid control training and other kinds of advanced skill training seem to increase crash risk, particularly among young males,” Dr. Johnston said.
What helps teens most is, ironically, more driving.
“If I say inexperience is the single most important risk factor for dying in a crash as a teen, driving experience is the intervention,” he said. More time spent driving – “with supervision in particular, and under diverse conditions,” Dr. Johnston said – increases the repertoire of skills and abilities.
Parents should be encouraged to ride along as their teens drive under diverse road conditions: different roads, different times of the day, and different weather conditions, for example. Parents can narrate their own driving, pointing out hazards and times when they slow down for increased caution, Dr. Johnston said. It might feel “awkward and unnatural,” but “some of the things you as a driver notice all the time are novel to teen drivers.”
Parents can influence road safety for teens in terms of their own behavior and in selecting a safer vehicle. A strong correlation exists between parental texting while driving when children are younger and what they do as teen drivers, for example.
Safer vehicles are bigger, heavier cars with electronic stability control, which reduces risk of death about as much as wearing seat belts. Parents should avoid vehicles with high horsepower and look for cars with the best safety ratings they can afford, Dr. Johnston said.
Several special features in newer cars can help reduce crash risk, such as blind spot detection, automatic breaking, collision avoidance systems, lane departure warning systems, and driver drowsiness detection. Parents may worry that relying on this technology could reduce teens’ learning, but it actually can compensate for skill deficits as they are becoming more skilled drivers.
Parents can look into feedback programs such as smartphone apps or other in-car units that allow parents to see data on teens’ speed, unsafe driving, “near-misses,” and similar driving behaviors. Research has shown that unsafe driving in newly licensed teens dropped by 66% over 4 months of using one of these feedback programs, compared with teens who didn’t use it.
Dr. Johnston also discussed the idea of prelicensure medical exams, similar to physicals that are required before playing sports. These already exist for commercial licenses in most states, but no data exist on whether it’s effective for teens. The goal would be to promote a discussion between parents and their teens about driving: reviewing medications the teen is taking and whether they affect driving; discussing safety of different vehicles; and assessing the teens’ risks, including any cognitive or other medical conditions that could affect driving safety. Even if such a “driving physical” is not currently required, pediatricians can do their own version of one with families.
Dr. Johnston had no disclosures.
NEW ORLEANS – Teens need to drive for a wide range of reasons, from going to and from school or work to overall mobility, but driving still is the most dangerous thing teenagers do, according to Brian Johnston, MD, MPH, professor of pediatrics at the University of Washington in Seattle.
Motor vehicle traffic accidents continue to be the leading cause of death of adolescents aged 15-19 years, according to 2017 data from the National Center for Health Statistics at the Centers for the Disease Control and Prevention.
“Inexperience drives the statistics we see,” Dr. Johnston said at the annual meeting of the American Academy of Pediatrics. “There is a steep learning curve among drivers of all ages, and crash rates are highest during the first few months after teens begin driving without supervision.”
Although the risk of accidents is higher than average for any new driver, it’s disproportionately higher for younger teens, compared with other ages: 16-year-old novice drivers have a higher accident risk than that of 17-year-olds, whose risk is similar to that of 18- and 19-year-old novices.
How long drivers have been licensed has a far bigger impact on crash risk, Dr. Johnston said (Traffic Inj. Prev. 2009 Jun;10[3]:209-19).
But the risk of an accident also increases with each additional passenger a teen driver has, particularly for younger and male drivers (Traffic Inj Prev. 2013;14[3]:283-92). More passengers likely means more distraction, and distraction, driving too fast for road conditions, and not scanning the roadway are the three most common errors – together accounting for about half of all teen drivers’ crashes.
Risk factors for accidents
Speed is a contributing factor in just over a third (36%) of teens’ fatal crashes. Adolescents drive faster and keep shorter following distances than adults do. But as with adults, wearing seat belts substantially reduces the risk of death in accidents.
Nationally, 90% of drivers use seat belts, with higher rates in states with primary enforcement (92%) than those in states with secondary enforcement (83%).
But barely more than half (54%) of U.S. high school students say they “always” wear a seat belt, and just under half of teens (47%) who died in crashes in 2017 weren’t wearing one. As seen in adults, teens are more likely to buckle up, by 12%, in states with primary seat belt laws.
Distraction during driving can be visual, manual, or cognitive – and handheld electronic devices such as smartphones cause all three distraction types. Cell phones nearly double the proportion of teen drivers who die in crashes, from 7% to 13%.
But if teens can keep their eyes on the roadway at all times, even the risks posed by cellphones drop considerably.
“The best evidence shows that secondary tasks only degrade driving performance when they require drivers to look away from the road,” Dr. Johnston said. Looking away for 2 seconds or longer increases crash risk more than fivefold.
Two other risk factors for teen car accidents are drowsiness and nighttime driving. Sleepiness can play a role in crashes at any time of day, and Dr. Johnston noted that some research has associated later high school start times with reduced crash risk.
Teens aged 16-19 years are about four times more likely to have a car accident at night than during the day per each mile driven, the pediatrician noted. Many licensing laws restrict teen driving starting at 11 p.m. or later, but about 50%-60% of their crashes occur between 9 and 11 p.m.
One reason for the increased risk is less experience driving in more difficult conditions, but teens also are more likely to have teen passengers, to be driving excessively fast, or to be under the influence of alcohol at night.
Adolescents’ crash risk is higher than that of adults for any level of blood alcohol content. Self-reported driving after drinking dropped by almost half – from 10% to 5.5% – from 2013 to 2017, but alcohol still is implicated in a substantial number of fatal teen crashes.
As drunk driving has declined, however, driving while under the influence of marijuana has been increasing. According to the National Highway Traffic Safety Administration, case control studies show drivers with tetrahydrocannabinol (THC) in their blood have a 25% increased risk of accidents – but the excess risk associated with THC vanishes when researchers control for age, sex, and concurrent use of alcohol. Not enough research exists to determine what the crash risk would be for adolescent drivers using THC alone.
A less-recognized risk factor for car accidents in teen drivers is ADHD, which increases a teen’s risk of crashing by 36%, particularly in the first month after getting a license, Dr. Johnston said.
ADHD medication appears to mitigate the danger, according to data: Crash risk was 40% lower in adult drivers with ADHD during months they filled their stimulant prescriptions. But one study found only 12% of teens with ADHD filled their prescriptions the month they got their license, and adolescents may not take their medications or still have them in their system on weekends or at night.
Teens recovering from concussion also may have an increased risk. Some evidence suggests driving impairment continues even when other symptoms have resolved, but not enough data exist to determine appropriate criteria for clearing teens to begin driving again.
Interventions to improve teens’ driving safety
Most teens take a basic driver education course before getting their licenses, but no evidence shows that it reduces risk of citations, crashes, or injury. In fact, “skid control training and other kinds of advanced skill training seem to increase crash risk, particularly among young males,” Dr. Johnston said.
What helps teens most is, ironically, more driving.
“If I say inexperience is the single most important risk factor for dying in a crash as a teen, driving experience is the intervention,” he said. More time spent driving – “with supervision in particular, and under diverse conditions,” Dr. Johnston said – increases the repertoire of skills and abilities.
Parents should be encouraged to ride along as their teens drive under diverse road conditions: different roads, different times of the day, and different weather conditions, for example. Parents can narrate their own driving, pointing out hazards and times when they slow down for increased caution, Dr. Johnston said. It might feel “awkward and unnatural,” but “some of the things you as a driver notice all the time are novel to teen drivers.”
Parents can influence road safety for teens in terms of their own behavior and in selecting a safer vehicle. A strong correlation exists between parental texting while driving when children are younger and what they do as teen drivers, for example.
Safer vehicles are bigger, heavier cars with electronic stability control, which reduces risk of death about as much as wearing seat belts. Parents should avoid vehicles with high horsepower and look for cars with the best safety ratings they can afford, Dr. Johnston said.
Several special features in newer cars can help reduce crash risk, such as blind spot detection, automatic breaking, collision avoidance systems, lane departure warning systems, and driver drowsiness detection. Parents may worry that relying on this technology could reduce teens’ learning, but it actually can compensate for skill deficits as they are becoming more skilled drivers.
Parents can look into feedback programs such as smartphone apps or other in-car units that allow parents to see data on teens’ speed, unsafe driving, “near-misses,” and similar driving behaviors. Research has shown that unsafe driving in newly licensed teens dropped by 66% over 4 months of using one of these feedback programs, compared with teens who didn’t use it.
Dr. Johnston also discussed the idea of prelicensure medical exams, similar to physicals that are required before playing sports. These already exist for commercial licenses in most states, but no data exist on whether it’s effective for teens. The goal would be to promote a discussion between parents and their teens about driving: reviewing medications the teen is taking and whether they affect driving; discussing safety of different vehicles; and assessing the teens’ risks, including any cognitive or other medical conditions that could affect driving safety. Even if such a “driving physical” is not currently required, pediatricians can do their own version of one with families.
Dr. Johnston had no disclosures.