User login
Childhood vaccine trauma decreases adolescent HPV immunization uptake
The more vaccines children get at any one office visit between the ages of 4 and 6 years, the more fearful they are of needles later on and the less likely they are to start human papillomavirus vaccine (HPV) as adolescents, according to an investigation of 120 children.
Shot-stacking between ages 4 and 6 years is not uncommon, especially if children might not be back in the office any time soon. Although it’s convenient and often better reimbursed to give all the recommended 4- to 6-year-old shots – MMR, DTaP, varicella, IPV, and maybe flu and hepatitis B vaccines – in one visit, the investigators found a hidden cost.
“We don’t need to change the vaccine schedule,” but we do have to be careful because 4- to 6-year-olds are especially vulnerable to phobias. “I think the best thing would be to give one vaccine at age 4, two at age 5, and two at age 6,” years, said lead investigator and pediatric emergency physician Amy Baxter, MD, a clinical associate professor at the Medical College of Georgia, Augusta.
“I’ve dealt with needle phobia in the ED. These kids come in and they are already freaked out about needles. If they get diagnosed with diabetes or leukemia, parents don’t think they are going to be able to handle it,” she said in an interview.
Expanded school vaccination programs might help by making it more convenient for parents to space out shots. The development of patch, microneedle, or effective sublingual or intranasal options also would help.
Dr. Baxter and her colleagues asked 120 children aged 10 to 12 years old to rate their fear of needles on a visual analogue scale (VAS), from 0 points meaning no fear to 100. The investigators matched the scores against the children’s immunization records (Vaccine. 2017 Jun 20. doi: 10.1016/j.vaccine.2017.06.029).
There was no significant relationship between needle fear and the total number of injections. However, fear did correlate with the number of shots children received in 1 day from ages 4 to 6 years old. Six children (50%) who had four same-day injections during that period scored in the upper quartile of anxiety as adolescents (VAS greater than 83), versus 22 (27%) who had three, and 2 (10%) who had two. None of the children who had just one shot per office visit as preschoolers were very worried about needles (P = .0387).
The investigators found that the likelihood of being in the upper quartile of fear as adolescents increased with each additional same-day injection between the ages of 4 and 6 years (odds ratio, 3.108; 95% confidence interval, 1.311-7.367; P = .01).
The team checked back with the children a few years later to see who had started HPV immunizations by age 14 years. Just 27% of children in the upper quartile of needle fear had done so, versus 48% in the least anxious quartile (VAS less than 32). The study wasn’t powered to detect a statistically significant difference in HPV vaccine uptake, but decreased uptake with higher needle fear came close (OR, 2.57; 95% CI, 0.864-7.621; P = .0889).
“It’s the stacking that causes fear. There was no difference in the uptake of vaccines when they were spread out, but more shots” at one time “causes more distress, so there was a difference in fear 5 years later,” Dr. Baxter said.
The investigators also assessed parental concerns about immunizations. “What was interesting was that whether the parents were in the upper or lower quartile of anxiety didn’t impact HPV initiation at all. The children’s anxiety 2 years earlier seemed much more relevant,” Dr. Baxter said.
In a literature review of 15 studies from 1958-2016 that included over 8,000 subjects, the investigators also found that needle fear tracked neatly with the sixfold increase in scheduled vaccines since the 1970s, with more than 60% of people now endorsing some degree of injection anxiety – more than ever before. “The curve of increasing needle fear correlated strongly with increasing vaccine number,” they found (Kendall’s tau b = 0.747; 95% CI, 0.513-0.982; P = .0003).
As two-thirds of the literature review sample were adults, “these results imply that fear acquired in childhood persists,” they concluded.
The majority of children in the study were white. Their mothers were a mean of 44 years, with a mean education level of 18 years. Demographic differences didn’t affect needle fear.
Dr. Baxter is a pediatric pain researcher and the inventor of Buzzy, a bumblebee shaped vibrator to distract children and relieve pain during shots. When asked if readers could trust her study findings given her interest in selling the device, she noted that, in a previous study, “Buzzy for 15 seconds did not work well for 4 to 6 year olds” getting multiple injections at one office visit. “Buzzy is not the solution for giving four shots at once.”
The more vaccines children get at any one office visit between the ages of 4 and 6 years, the more fearful they are of needles later on and the less likely they are to start human papillomavirus vaccine (HPV) as adolescents, according to an investigation of 120 children.
Shot-stacking between ages 4 and 6 years is not uncommon, especially if children might not be back in the office any time soon. Although it’s convenient and often better reimbursed to give all the recommended 4- to 6-year-old shots – MMR, DTaP, varicella, IPV, and maybe flu and hepatitis B vaccines – in one visit, the investigators found a hidden cost.
“We don’t need to change the vaccine schedule,” but we do have to be careful because 4- to 6-year-olds are especially vulnerable to phobias. “I think the best thing would be to give one vaccine at age 4, two at age 5, and two at age 6,” years, said lead investigator and pediatric emergency physician Amy Baxter, MD, a clinical associate professor at the Medical College of Georgia, Augusta.
“I’ve dealt with needle phobia in the ED. These kids come in and they are already freaked out about needles. If they get diagnosed with diabetes or leukemia, parents don’t think they are going to be able to handle it,” she said in an interview.
Expanded school vaccination programs might help by making it more convenient for parents to space out shots. The development of patch, microneedle, or effective sublingual or intranasal options also would help.
Dr. Baxter and her colleagues asked 120 children aged 10 to 12 years old to rate their fear of needles on a visual analogue scale (VAS), from 0 points meaning no fear to 100. The investigators matched the scores against the children’s immunization records (Vaccine. 2017 Jun 20. doi: 10.1016/j.vaccine.2017.06.029).
There was no significant relationship between needle fear and the total number of injections. However, fear did correlate with the number of shots children received in 1 day from ages 4 to 6 years old. Six children (50%) who had four same-day injections during that period scored in the upper quartile of anxiety as adolescents (VAS greater than 83), versus 22 (27%) who had three, and 2 (10%) who had two. None of the children who had just one shot per office visit as preschoolers were very worried about needles (P = .0387).
The investigators found that the likelihood of being in the upper quartile of fear as adolescents increased with each additional same-day injection between the ages of 4 and 6 years (odds ratio, 3.108; 95% confidence interval, 1.311-7.367; P = .01).
The team checked back with the children a few years later to see who had started HPV immunizations by age 14 years. Just 27% of children in the upper quartile of needle fear had done so, versus 48% in the least anxious quartile (VAS less than 32). The study wasn’t powered to detect a statistically significant difference in HPV vaccine uptake, but decreased uptake with higher needle fear came close (OR, 2.57; 95% CI, 0.864-7.621; P = .0889).
“It’s the stacking that causes fear. There was no difference in the uptake of vaccines when they were spread out, but more shots” at one time “causes more distress, so there was a difference in fear 5 years later,” Dr. Baxter said.
The investigators also assessed parental concerns about immunizations. “What was interesting was that whether the parents were in the upper or lower quartile of anxiety didn’t impact HPV initiation at all. The children’s anxiety 2 years earlier seemed much more relevant,” Dr. Baxter said.
In a literature review of 15 studies from 1958-2016 that included over 8,000 subjects, the investigators also found that needle fear tracked neatly with the sixfold increase in scheduled vaccines since the 1970s, with more than 60% of people now endorsing some degree of injection anxiety – more than ever before. “The curve of increasing needle fear correlated strongly with increasing vaccine number,” they found (Kendall’s tau b = 0.747; 95% CI, 0.513-0.982; P = .0003).
As two-thirds of the literature review sample were adults, “these results imply that fear acquired in childhood persists,” they concluded.
The majority of children in the study were white. Their mothers were a mean of 44 years, with a mean education level of 18 years. Demographic differences didn’t affect needle fear.
Dr. Baxter is a pediatric pain researcher and the inventor of Buzzy, a bumblebee shaped vibrator to distract children and relieve pain during shots. When asked if readers could trust her study findings given her interest in selling the device, she noted that, in a previous study, “Buzzy for 15 seconds did not work well for 4 to 6 year olds” getting multiple injections at one office visit. “Buzzy is not the solution for giving four shots at once.”
The more vaccines children get at any one office visit between the ages of 4 and 6 years, the more fearful they are of needles later on and the less likely they are to start human papillomavirus vaccine (HPV) as adolescents, according to an investigation of 120 children.
Shot-stacking between ages 4 and 6 years is not uncommon, especially if children might not be back in the office any time soon. Although it’s convenient and often better reimbursed to give all the recommended 4- to 6-year-old shots – MMR, DTaP, varicella, IPV, and maybe flu and hepatitis B vaccines – in one visit, the investigators found a hidden cost.
“We don’t need to change the vaccine schedule,” but we do have to be careful because 4- to 6-year-olds are especially vulnerable to phobias. “I think the best thing would be to give one vaccine at age 4, two at age 5, and two at age 6,” years, said lead investigator and pediatric emergency physician Amy Baxter, MD, a clinical associate professor at the Medical College of Georgia, Augusta.
“I’ve dealt with needle phobia in the ED. These kids come in and they are already freaked out about needles. If they get diagnosed with diabetes or leukemia, parents don’t think they are going to be able to handle it,” she said in an interview.
Expanded school vaccination programs might help by making it more convenient for parents to space out shots. The development of patch, microneedle, or effective sublingual or intranasal options also would help.
Dr. Baxter and her colleagues asked 120 children aged 10 to 12 years old to rate their fear of needles on a visual analogue scale (VAS), from 0 points meaning no fear to 100. The investigators matched the scores against the children’s immunization records (Vaccine. 2017 Jun 20. doi: 10.1016/j.vaccine.2017.06.029).
There was no significant relationship between needle fear and the total number of injections. However, fear did correlate with the number of shots children received in 1 day from ages 4 to 6 years old. Six children (50%) who had four same-day injections during that period scored in the upper quartile of anxiety as adolescents (VAS greater than 83), versus 22 (27%) who had three, and 2 (10%) who had two. None of the children who had just one shot per office visit as preschoolers were very worried about needles (P = .0387).
The investigators found that the likelihood of being in the upper quartile of fear as adolescents increased with each additional same-day injection between the ages of 4 and 6 years (odds ratio, 3.108; 95% confidence interval, 1.311-7.367; P = .01).
The team checked back with the children a few years later to see who had started HPV immunizations by age 14 years. Just 27% of children in the upper quartile of needle fear had done so, versus 48% in the least anxious quartile (VAS less than 32). The study wasn’t powered to detect a statistically significant difference in HPV vaccine uptake, but decreased uptake with higher needle fear came close (OR, 2.57; 95% CI, 0.864-7.621; P = .0889).
“It’s the stacking that causes fear. There was no difference in the uptake of vaccines when they were spread out, but more shots” at one time “causes more distress, so there was a difference in fear 5 years later,” Dr. Baxter said.
The investigators also assessed parental concerns about immunizations. “What was interesting was that whether the parents were in the upper or lower quartile of anxiety didn’t impact HPV initiation at all. The children’s anxiety 2 years earlier seemed much more relevant,” Dr. Baxter said.
In a literature review of 15 studies from 1958-2016 that included over 8,000 subjects, the investigators also found that needle fear tracked neatly with the sixfold increase in scheduled vaccines since the 1970s, with more than 60% of people now endorsing some degree of injection anxiety – more than ever before. “The curve of increasing needle fear correlated strongly with increasing vaccine number,” they found (Kendall’s tau b = 0.747; 95% CI, 0.513-0.982; P = .0003).
As two-thirds of the literature review sample were adults, “these results imply that fear acquired in childhood persists,” they concluded.
The majority of children in the study were white. Their mothers were a mean of 44 years, with a mean education level of 18 years. Demographic differences didn’t affect needle fear.
Dr. Baxter is a pediatric pain researcher and the inventor of Buzzy, a bumblebee shaped vibrator to distract children and relieve pain during shots. When asked if readers could trust her study findings given her interest in selling the device, she noted that, in a previous study, “Buzzy for 15 seconds did not work well for 4 to 6 year olds” getting multiple injections at one office visit. “Buzzy is not the solution for giving four shots at once.”
FROM VACCINE
Key clinical point:
Major finding: Six children (50%) who had four same-day injections during that period scored in the upper quartile of anxiety as adolescents (VAS greater than 83), versus 22 (27%) who had three, and 2 (10%) who had two same-day injections. Just 27% of children in the upper quartile of needle fear had started HPV immunization at age 14 years, versus 48% in the least anxious quartile.
Data source: Survey and follow-up of 120 children and their parents.
Disclosures: The lead investigator is a pediatric pain researcher and the inventor of Buzzy, a bumblebee shaped vibrator to distract children and relieve pain during shots. When asked if readers could trust her findings given her interest in selling the device, she noted that, in a previous study, “Buzzy for 15 seconds did not work well for 4-6 year olds” getting multiple injections in one office visit. “Buzzy is not the solution for giving four shots at once.”
Nurses help more rheumatic disease patients get vaccinated
MADRID – A nurse-led program successfully increased the uptake of pneumococcal vaccination among patients with chronic inflammatory rheumatic diseases in a single-center study.
From the start to the end of a 4-month evaluation period, the rate of vaccination of at-risk patients increased from 17.1% (13/76) to 77.6% (59/76; P less than .001).
It is well known that patients with inflammatory rheumatic diseases, such as systemic lupus erythematous (SLE) and systemic vasculitis, are at high risk for contracting pneumococcal disease, reported Tiphaine Goulenok, MD, of Bichat Hospital, Paris, at the European Congress of Rheumatology. This is particularly the case if they are receiving immunosuppressive treatments.
Although French national guidelines were introduced in 2011 that recommend that such patients routinely receive pneumococcal vaccination, the vaccination rate is often lower than is desirable, Dr. Goulenok observed at a press briefing. Her prior research suggests that only 16.2% of patients with an indication for the PCV13 vaccine actually received it.
In the current study, 126 patients with inflammatory rheumatic diseases were consecutively recruited and seen at the day unit of Bichat Hospital. Of these patients, 76 were candidates for pneumococcal vaccination because they were receiving steroids or other immunosuppressive drugs. Of these patients, 13 were already vaccinated, and, of the 63 who were not, nurses correctly identified 56 (88.9%) who needed to be vaccinated, of whom 46 agreed and 10 refused.
“We found a low rate of pneumococcal vaccination among patients,” said Dr. Goulenok, “but, thanks to high screening by the nurses, vaccination coverage was increased and the nurse-led vaccination program was very efficient”.
Robert Landewé, MD, who chaired the press briefing, observed that, despite being in an “era of guidelines,” ways of successfully implementing them in practice remained a challenge. The nurse-led program appeared to be one way to increase pneumococcal vaccination uptake, but perhaps other ways need to be sought, especially as there may be substantial resistance to vaccination among patients, he said.
“Patients are sometimes more afraid of the consequences of vaccination than [of] the disease that is prevented by vaccination,” said Dr. Landewé, who is professor of rheumatology at the Academic Medical Center in Amsterdam (the Netherlands).
Dr. Goulenok and Dr. Landewé reported no disclosures.
MADRID – A nurse-led program successfully increased the uptake of pneumococcal vaccination among patients with chronic inflammatory rheumatic diseases in a single-center study.
From the start to the end of a 4-month evaluation period, the rate of vaccination of at-risk patients increased from 17.1% (13/76) to 77.6% (59/76; P less than .001).
It is well known that patients with inflammatory rheumatic diseases, such as systemic lupus erythematous (SLE) and systemic vasculitis, are at high risk for contracting pneumococcal disease, reported Tiphaine Goulenok, MD, of Bichat Hospital, Paris, at the European Congress of Rheumatology. This is particularly the case if they are receiving immunosuppressive treatments.
Although French national guidelines were introduced in 2011 that recommend that such patients routinely receive pneumococcal vaccination, the vaccination rate is often lower than is desirable, Dr. Goulenok observed at a press briefing. Her prior research suggests that only 16.2% of patients with an indication for the PCV13 vaccine actually received it.
In the current study, 126 patients with inflammatory rheumatic diseases were consecutively recruited and seen at the day unit of Bichat Hospital. Of these patients, 76 were candidates for pneumococcal vaccination because they were receiving steroids or other immunosuppressive drugs. Of these patients, 13 were already vaccinated, and, of the 63 who were not, nurses correctly identified 56 (88.9%) who needed to be vaccinated, of whom 46 agreed and 10 refused.
“We found a low rate of pneumococcal vaccination among patients,” said Dr. Goulenok, “but, thanks to high screening by the nurses, vaccination coverage was increased and the nurse-led vaccination program was very efficient”.
Robert Landewé, MD, who chaired the press briefing, observed that, despite being in an “era of guidelines,” ways of successfully implementing them in practice remained a challenge. The nurse-led program appeared to be one way to increase pneumococcal vaccination uptake, but perhaps other ways need to be sought, especially as there may be substantial resistance to vaccination among patients, he said.
“Patients are sometimes more afraid of the consequences of vaccination than [of] the disease that is prevented by vaccination,” said Dr. Landewé, who is professor of rheumatology at the Academic Medical Center in Amsterdam (the Netherlands).
Dr. Goulenok and Dr. Landewé reported no disclosures.
MADRID – A nurse-led program successfully increased the uptake of pneumococcal vaccination among patients with chronic inflammatory rheumatic diseases in a single-center study.
From the start to the end of a 4-month evaluation period, the rate of vaccination of at-risk patients increased from 17.1% (13/76) to 77.6% (59/76; P less than .001).
It is well known that patients with inflammatory rheumatic diseases, such as systemic lupus erythematous (SLE) and systemic vasculitis, are at high risk for contracting pneumococcal disease, reported Tiphaine Goulenok, MD, of Bichat Hospital, Paris, at the European Congress of Rheumatology. This is particularly the case if they are receiving immunosuppressive treatments.
Although French national guidelines were introduced in 2011 that recommend that such patients routinely receive pneumococcal vaccination, the vaccination rate is often lower than is desirable, Dr. Goulenok observed at a press briefing. Her prior research suggests that only 16.2% of patients with an indication for the PCV13 vaccine actually received it.
In the current study, 126 patients with inflammatory rheumatic diseases were consecutively recruited and seen at the day unit of Bichat Hospital. Of these patients, 76 were candidates for pneumococcal vaccination because they were receiving steroids or other immunosuppressive drugs. Of these patients, 13 were already vaccinated, and, of the 63 who were not, nurses correctly identified 56 (88.9%) who needed to be vaccinated, of whom 46 agreed and 10 refused.
“We found a low rate of pneumococcal vaccination among patients,” said Dr. Goulenok, “but, thanks to high screening by the nurses, vaccination coverage was increased and the nurse-led vaccination program was very efficient”.
Robert Landewé, MD, who chaired the press briefing, observed that, despite being in an “era of guidelines,” ways of successfully implementing them in practice remained a challenge. The nurse-led program appeared to be one way to increase pneumococcal vaccination uptake, but perhaps other ways need to be sought, especially as there may be substantial resistance to vaccination among patients, he said.
“Patients are sometimes more afraid of the consequences of vaccination than [of] the disease that is prevented by vaccination,” said Dr. Landewé, who is professor of rheumatology at the Academic Medical Center in Amsterdam (the Netherlands).
Dr. Goulenok and Dr. Landewé reported no disclosures.
AT THE EULAR 2017 CONGRESS
Key clinical point: A nurse-led program increased the uptake of a guideline-recommended vaccination in patients with chronic inflammatory rheumatic diseases.
Major finding: The pre- and postintervention pneumococcal vaccination rates were 17.1% (13/76) and 77.6% (59/76) of at-risk patients (P less than .001).
Data source: A 4-month, prospective pilot study of 126 consecutively recruited patients with chronic inflammatory rheumatic diseases.
Disclosures: The presenter and commentator had no disclosures to report.
English infant quadravalent group B meningococcal vaccine pays off
MADRID – Cases of invasive meningococcal disease in English 1 year olds dropped fourfold in the first year after the multicomponent group B meningococcal (MenB) vaccine (4CMenB, Bexsero) was added to the national infant immunization list, Shamez Ladhani, MD, Ph.D, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“In 1 year olds, we have seen a significant decrease in the number of cases, compared with the number of cases predicted. I suspect the vaccine effectiveness is close to 94% against meningococcal group B,” said Dr. Ladhani of Public Health England, London.
Meningococcal meningitis and septicemia remain the leading cause of death for children under 5 in the UK. Public awareness of this threat is high, so 4CMenB has been well accepted. Of eligible infants, 96% have received the first dose and 89% the second. The first cohort became available for the 12-month booster dose in May 2016.
Between May and December of 2016, the Public Health England intensive surveillance program confirmed six cases of invasive meningococcal disease. During the same time frame in 2015, there were 24 cases, whereas, during the 4 years prior to introduction of 4CMenB, the average was 18 cases per year.
Three of the six 1-year-olds had meningitis, and three had septicemia. One was admitted to an ICU. None died. None had comorbid conditions placing them at increased risk. Five of the six children with invasive meningococcal disease had received two doses of the vaccine, and one child became ill 3 months after receiving the third dose.
The vaccine is licensed to be given as a four-dose series: three primary doses plus one booster dose. UK health officials deemed that excessive and not cost effective. Based on data from the vaccine trials, they determined that three doses are sufficient. This cut the cost of the national program by 25% while maintaining protection (Lancet. 2016 Dec 3;388(10061):2775-82).
Pediatricians from other countries were extremely curious about this innovative immunization program. What about vaccine side effects in infants? they asked.
Dr. Ladhani replied that studies in Australia, Northern Ireland, and Scotland have all shown a small uptick in mild fever and irritability in the first 3 days after the first dose of 4CMenB. It’s less of an issue with the second dose.
“One dose is not protective. You need two. Parents understand that, while these side effects are annoying, the risks associated with meningitis are far greater. They are very, very accepting of the vaccine,” according to Dr. Ladhani.
What about using 4CMenB in teenagers? physicians asked.
Dr. Ladhani predicted that the infant immunization program will have zero effect in adolescents. Teens are the main carriers of meningococcal bacteria. So, in theory, vaccinating them could not only protect the adolescents themselves but could benefit the whole population through herd immunity.
“The problem is we don’t have solid evidence that Bexsero protects against carriage. A massive carriage study is underway in Australia. It should provide data in 2 or 3 years. If we do see a carriage effect, then vaccinating teenagers becomes a very attractive option because you protect them and others around them,” he explained.
Dr. Ladhani reported having no financial conflicts regarding his study, funded by Public Health England.
MADRID – Cases of invasive meningococcal disease in English 1 year olds dropped fourfold in the first year after the multicomponent group B meningococcal (MenB) vaccine (4CMenB, Bexsero) was added to the national infant immunization list, Shamez Ladhani, MD, Ph.D, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“In 1 year olds, we have seen a significant decrease in the number of cases, compared with the number of cases predicted. I suspect the vaccine effectiveness is close to 94% against meningococcal group B,” said Dr. Ladhani of Public Health England, London.
Meningococcal meningitis and septicemia remain the leading cause of death for children under 5 in the UK. Public awareness of this threat is high, so 4CMenB has been well accepted. Of eligible infants, 96% have received the first dose and 89% the second. The first cohort became available for the 12-month booster dose in May 2016.
Between May and December of 2016, the Public Health England intensive surveillance program confirmed six cases of invasive meningococcal disease. During the same time frame in 2015, there were 24 cases, whereas, during the 4 years prior to introduction of 4CMenB, the average was 18 cases per year.
Three of the six 1-year-olds had meningitis, and three had septicemia. One was admitted to an ICU. None died. None had comorbid conditions placing them at increased risk. Five of the six children with invasive meningococcal disease had received two doses of the vaccine, and one child became ill 3 months after receiving the third dose.
The vaccine is licensed to be given as a four-dose series: three primary doses plus one booster dose. UK health officials deemed that excessive and not cost effective. Based on data from the vaccine trials, they determined that three doses are sufficient. This cut the cost of the national program by 25% while maintaining protection (Lancet. 2016 Dec 3;388(10061):2775-82).
Pediatricians from other countries were extremely curious about this innovative immunization program. What about vaccine side effects in infants? they asked.
Dr. Ladhani replied that studies in Australia, Northern Ireland, and Scotland have all shown a small uptick in mild fever and irritability in the first 3 days after the first dose of 4CMenB. It’s less of an issue with the second dose.
“One dose is not protective. You need two. Parents understand that, while these side effects are annoying, the risks associated with meningitis are far greater. They are very, very accepting of the vaccine,” according to Dr. Ladhani.
What about using 4CMenB in teenagers? physicians asked.
Dr. Ladhani predicted that the infant immunization program will have zero effect in adolescents. Teens are the main carriers of meningococcal bacteria. So, in theory, vaccinating them could not only protect the adolescents themselves but could benefit the whole population through herd immunity.
“The problem is we don’t have solid evidence that Bexsero protects against carriage. A massive carriage study is underway in Australia. It should provide data in 2 or 3 years. If we do see a carriage effect, then vaccinating teenagers becomes a very attractive option because you protect them and others around them,” he explained.
Dr. Ladhani reported having no financial conflicts regarding his study, funded by Public Health England.
MADRID – Cases of invasive meningococcal disease in English 1 year olds dropped fourfold in the first year after the multicomponent group B meningococcal (MenB) vaccine (4CMenB, Bexsero) was added to the national infant immunization list, Shamez Ladhani, MD, Ph.D, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“In 1 year olds, we have seen a significant decrease in the number of cases, compared with the number of cases predicted. I suspect the vaccine effectiveness is close to 94% against meningococcal group B,” said Dr. Ladhani of Public Health England, London.
Meningococcal meningitis and septicemia remain the leading cause of death for children under 5 in the UK. Public awareness of this threat is high, so 4CMenB has been well accepted. Of eligible infants, 96% have received the first dose and 89% the second. The first cohort became available for the 12-month booster dose in May 2016.
Between May and December of 2016, the Public Health England intensive surveillance program confirmed six cases of invasive meningococcal disease. During the same time frame in 2015, there were 24 cases, whereas, during the 4 years prior to introduction of 4CMenB, the average was 18 cases per year.
Three of the six 1-year-olds had meningitis, and three had septicemia. One was admitted to an ICU. None died. None had comorbid conditions placing them at increased risk. Five of the six children with invasive meningococcal disease had received two doses of the vaccine, and one child became ill 3 months after receiving the third dose.
The vaccine is licensed to be given as a four-dose series: three primary doses plus one booster dose. UK health officials deemed that excessive and not cost effective. Based on data from the vaccine trials, they determined that three doses are sufficient. This cut the cost of the national program by 25% while maintaining protection (Lancet. 2016 Dec 3;388(10061):2775-82).
Pediatricians from other countries were extremely curious about this innovative immunization program. What about vaccine side effects in infants? they asked.
Dr. Ladhani replied that studies in Australia, Northern Ireland, and Scotland have all shown a small uptick in mild fever and irritability in the first 3 days after the first dose of 4CMenB. It’s less of an issue with the second dose.
“One dose is not protective. You need two. Parents understand that, while these side effects are annoying, the risks associated with meningitis are far greater. They are very, very accepting of the vaccine,” according to Dr. Ladhani.
What about using 4CMenB in teenagers? physicians asked.
Dr. Ladhani predicted that the infant immunization program will have zero effect in adolescents. Teens are the main carriers of meningococcal bacteria. So, in theory, vaccinating them could not only protect the adolescents themselves but could benefit the whole population through herd immunity.
“The problem is we don’t have solid evidence that Bexsero protects against carriage. A massive carriage study is underway in Australia. It should provide data in 2 or 3 years. If we do see a carriage effect, then vaccinating teenagers becomes a very attractive option because you protect them and others around them,” he explained.
Dr. Ladhani reported having no financial conflicts regarding his study, funded by Public Health England.
AT ESPID 2017
Key clinical point:
Major finding: The number of confirmed cases of invasive meningococcal disease in English 1-year-olds dropped to six the year after introduction of the 4CMenB vaccine in the infant immunization schedule, down from 24 cases the previous year.
Data source: An enhanced surveillance study utilizing a combination of laboratory, public health, and clinical reporting to track and confirm all cases of invasive meningococcal disease in English 1-year-olds.
Disclosures: The study was funded by Public Health England. The presenter, who is employed by the agency, reported having no financial conflicts.
Transient tachypnea of newborn increases bronchiolitis risk
MADRID – A new Finnish study raises a provocative question: Is transient tachypnea of the newborn really transient?
Transient tachypnea of the newborn (TTN) has traditionally been viewed as a benign, self-limited condition involving 1-3 days of respiratory distress. But data from Finland’s comprehensive national health registries indicate that TTN in term babies is associated with significantly increased risk of subsequent bronchiolitis during infancy, Otto Helve, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“This association suggests similar pathogenic mechanisms in transient tachypnea of the newborn and bronchiolitis. We suggest that an intrinsic defect in sodium ion–driven pulmonary fluid transport may predispose to clinically significant bronchiolitis during the first year of life,” said Dr. Helve, a pediatrician at the National Institute for Health and Welfare, Helsinki, and the University of Helsinki.
Of more than 1 million term babies born in Finland during 1996-2015, 17,569 were diagnosed with TTN. During the same period, 40,338 infants were hospitalized with a diagnosis of bronchiolitis attributable to respiratory syncytial virus infection.
In a multivariate analysis adjusted for birth year, gender, delivery method, gestational age, and parity, TTN was independently associated with a 1.2-fold increased risk of bronchiolitis during the first year of life.
Dr. Helve reported having no financial conflicts of interest regarding his study.
MADRID – A new Finnish study raises a provocative question: Is transient tachypnea of the newborn really transient?
Transient tachypnea of the newborn (TTN) has traditionally been viewed as a benign, self-limited condition involving 1-3 days of respiratory distress. But data from Finland’s comprehensive national health registries indicate that TTN in term babies is associated with significantly increased risk of subsequent bronchiolitis during infancy, Otto Helve, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“This association suggests similar pathogenic mechanisms in transient tachypnea of the newborn and bronchiolitis. We suggest that an intrinsic defect in sodium ion–driven pulmonary fluid transport may predispose to clinically significant bronchiolitis during the first year of life,” said Dr. Helve, a pediatrician at the National Institute for Health and Welfare, Helsinki, and the University of Helsinki.
Of more than 1 million term babies born in Finland during 1996-2015, 17,569 were diagnosed with TTN. During the same period, 40,338 infants were hospitalized with a diagnosis of bronchiolitis attributable to respiratory syncytial virus infection.
In a multivariate analysis adjusted for birth year, gender, delivery method, gestational age, and parity, TTN was independently associated with a 1.2-fold increased risk of bronchiolitis during the first year of life.
Dr. Helve reported having no financial conflicts of interest regarding his study.
MADRID – A new Finnish study raises a provocative question: Is transient tachypnea of the newborn really transient?
Transient tachypnea of the newborn (TTN) has traditionally been viewed as a benign, self-limited condition involving 1-3 days of respiratory distress. But data from Finland’s comprehensive national health registries indicate that TTN in term babies is associated with significantly increased risk of subsequent bronchiolitis during infancy, Otto Helve, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“This association suggests similar pathogenic mechanisms in transient tachypnea of the newborn and bronchiolitis. We suggest that an intrinsic defect in sodium ion–driven pulmonary fluid transport may predispose to clinically significant bronchiolitis during the first year of life,” said Dr. Helve, a pediatrician at the National Institute for Health and Welfare, Helsinki, and the University of Helsinki.
Of more than 1 million term babies born in Finland during 1996-2015, 17,569 were diagnosed with TTN. During the same period, 40,338 infants were hospitalized with a diagnosis of bronchiolitis attributable to respiratory syncytial virus infection.
In a multivariate analysis adjusted for birth year, gender, delivery method, gestational age, and parity, TTN was independently associated with a 1.2-fold increased risk of bronchiolitis during the first year of life.
Dr. Helve reported having no financial conflicts of interest regarding his study.
AT ESPID 2017
Key clinical point:
Major finding: Transient tachypnea of the newborn was independently associated with a 1.2-fold increased risk of bronchiolitis during the first year of life of Finnish term babies.
Data source: This population-based case-control study included 17,569 Finnish term babies diagnosed with transient tachypnea of the newborn and 40,338 diagnosed with bronchiolitis.
Disclosures: Dr. Helve reported having no financial conflicts of interest.
Study validates EULAR definition of arthralgia suspicious for progression to RA
Results of a longitudinal study have confirmed that the recently established EULAR definition of arthralgia suspicious for progression to rheumatoid arthritis can help to distinguish patients who are at highest risk for progression from those who do not progress to RA.
Patients clinically suspected of arthralgia who met the definition for arthralgia suspicious for progression to RA displayed an increased risk for arthritis development, compared with patients who did not meet the EULAR definition (hazard ratio, 2.1; 95% confidence interval, 0.9-4.7). The approach had a sensitivity of 83% and positive predictive value of 30%, study head Annette van der Helm–van Mil, MD, reported at the European Congress of Rheumatology in Madrid.
The findings should help investigators looking at early arthritis progression to design better clinical trials by enabling more homogeneous populations of patients to be included, said Dr. van der Helm–van Mil, professor of rheumatology at Leiden University Medical Center and at Erasmus Medical Center in Rotterdam, both in the Netherlands.
“Previous data have shown that rheumatologists do recognize patients at risk for RA based on their clinical expertise and pattern recognition. So, they do recognize patients who have a combination of clinical characteristics that characterize the symptomatic prearthritis stage of RA. (This pattern is also called clinically suspect arthralgia,)” Dr. van der Helm–van Mil said in an interview.
However, the disadvantage of rheumatologists’ use of pattern recognition to identify patients at risk for RA is that it can be subjective, she said.
Several proof-of-concept trials are testing the hypothesis that the disease is more susceptible to disease-modifying treatment in the symptomatic prearthritis phase and that such early treatment might even prevent progression to chronic RA. But, selecting the “correct symptomatic patient” for early treatment with disease-modifying antirheumatic drugs is important, she said. Such a patient does not have clinical arthritis but is truly at risk for RA. Not all arthralgia patients are similar, and the type of arthralgia that is the hallmark for a heightened risk of progression to RA had not been defined formally prior to the EULAR definition.
A EULAR task force sought to provide some objective clarity by defining arthralgia at risk for RA (Ann Rheum Dis. 2017;76:491-6). The process relied on clinical expertise at all stages. However, until now, the definition had not been validated longitudinally. The current study used progression from arthralgia to clinical arthritis or RA as the outcome.
The definition of arthralgia at risk for RA hinges on seven parameters: symptom duration less than 1 year, symptoms in metacarpophalangeal joints, morning stiffness lasting an hour or more, symptoms that are worst in the morning, family history of RA, difficulty forming a fist, and positive squeeze test of metacarpophalangeal joints.
The researchers used those seven parameters to follow 241 Dutch patients considered likely to develop RA and 113 patients with recent-onset arthralgia in small joints who had not been evaluated by rheumatologists and who were referred to secondary care.
“The EULAR definition was developed for use in scientific studies and this definition is immediately applicable for this purpose,” Dr. van der Helm–van Mil said.
“With regards to application in daily practice, the clinical definition should be combined with results of additional investigations to accurately identify imminent RA in the phase of arthralgia. Which combination of markers yields the best accuracy is a subject for further studies,” Dr. van der Helm–van Mil said.
An important aspect of the task force’s definition is that rheumatologists should use it in patients in whom they consider imminent RA more likely than other diagnoses. The definition was not discriminative for RA when the investigators of the current study ignored this entry criterion, leading to a sensitivity of just 10% and positive predictive value of 3%.
“This suggests that the definition should be used in secondary care but may not be useful in primary care. However, more research is needed here,” Dr. van der Helm–van Mil said.
The authors reported no disclosures of interest.
Results of a longitudinal study have confirmed that the recently established EULAR definition of arthralgia suspicious for progression to rheumatoid arthritis can help to distinguish patients who are at highest risk for progression from those who do not progress to RA.
Patients clinically suspected of arthralgia who met the definition for arthralgia suspicious for progression to RA displayed an increased risk for arthritis development, compared with patients who did not meet the EULAR definition (hazard ratio, 2.1; 95% confidence interval, 0.9-4.7). The approach had a sensitivity of 83% and positive predictive value of 30%, study head Annette van der Helm–van Mil, MD, reported at the European Congress of Rheumatology in Madrid.
The findings should help investigators looking at early arthritis progression to design better clinical trials by enabling more homogeneous populations of patients to be included, said Dr. van der Helm–van Mil, professor of rheumatology at Leiden University Medical Center and at Erasmus Medical Center in Rotterdam, both in the Netherlands.
“Previous data have shown that rheumatologists do recognize patients at risk for RA based on their clinical expertise and pattern recognition. So, they do recognize patients who have a combination of clinical characteristics that characterize the symptomatic prearthritis stage of RA. (This pattern is also called clinically suspect arthralgia,)” Dr. van der Helm–van Mil said in an interview.
However, the disadvantage of rheumatologists’ use of pattern recognition to identify patients at risk for RA is that it can be subjective, she said.
Several proof-of-concept trials are testing the hypothesis that the disease is more susceptible to disease-modifying treatment in the symptomatic prearthritis phase and that such early treatment might even prevent progression to chronic RA. But, selecting the “correct symptomatic patient” for early treatment with disease-modifying antirheumatic drugs is important, she said. Such a patient does not have clinical arthritis but is truly at risk for RA. Not all arthralgia patients are similar, and the type of arthralgia that is the hallmark for a heightened risk of progression to RA had not been defined formally prior to the EULAR definition.
A EULAR task force sought to provide some objective clarity by defining arthralgia at risk for RA (Ann Rheum Dis. 2017;76:491-6). The process relied on clinical expertise at all stages. However, until now, the definition had not been validated longitudinally. The current study used progression from arthralgia to clinical arthritis or RA as the outcome.
The definition of arthralgia at risk for RA hinges on seven parameters: symptom duration less than 1 year, symptoms in metacarpophalangeal joints, morning stiffness lasting an hour or more, symptoms that are worst in the morning, family history of RA, difficulty forming a fist, and positive squeeze test of metacarpophalangeal joints.
The researchers used those seven parameters to follow 241 Dutch patients considered likely to develop RA and 113 patients with recent-onset arthralgia in small joints who had not been evaluated by rheumatologists and who were referred to secondary care.
“The EULAR definition was developed for use in scientific studies and this definition is immediately applicable for this purpose,” Dr. van der Helm–van Mil said.
“With regards to application in daily practice, the clinical definition should be combined with results of additional investigations to accurately identify imminent RA in the phase of arthralgia. Which combination of markers yields the best accuracy is a subject for further studies,” Dr. van der Helm–van Mil said.
An important aspect of the task force’s definition is that rheumatologists should use it in patients in whom they consider imminent RA more likely than other diagnoses. The definition was not discriminative for RA when the investigators of the current study ignored this entry criterion, leading to a sensitivity of just 10% and positive predictive value of 3%.
“This suggests that the definition should be used in secondary care but may not be useful in primary care. However, more research is needed here,” Dr. van der Helm–van Mil said.
The authors reported no disclosures of interest.
Results of a longitudinal study have confirmed that the recently established EULAR definition of arthralgia suspicious for progression to rheumatoid arthritis can help to distinguish patients who are at highest risk for progression from those who do not progress to RA.
Patients clinically suspected of arthralgia who met the definition for arthralgia suspicious for progression to RA displayed an increased risk for arthritis development, compared with patients who did not meet the EULAR definition (hazard ratio, 2.1; 95% confidence interval, 0.9-4.7). The approach had a sensitivity of 83% and positive predictive value of 30%, study head Annette van der Helm–van Mil, MD, reported at the European Congress of Rheumatology in Madrid.
The findings should help investigators looking at early arthritis progression to design better clinical trials by enabling more homogeneous populations of patients to be included, said Dr. van der Helm–van Mil, professor of rheumatology at Leiden University Medical Center and at Erasmus Medical Center in Rotterdam, both in the Netherlands.
“Previous data have shown that rheumatologists do recognize patients at risk for RA based on their clinical expertise and pattern recognition. So, they do recognize patients who have a combination of clinical characteristics that characterize the symptomatic prearthritis stage of RA. (This pattern is also called clinically suspect arthralgia,)” Dr. van der Helm–van Mil said in an interview.
However, the disadvantage of rheumatologists’ use of pattern recognition to identify patients at risk for RA is that it can be subjective, she said.
Several proof-of-concept trials are testing the hypothesis that the disease is more susceptible to disease-modifying treatment in the symptomatic prearthritis phase and that such early treatment might even prevent progression to chronic RA. But, selecting the “correct symptomatic patient” for early treatment with disease-modifying antirheumatic drugs is important, she said. Such a patient does not have clinical arthritis but is truly at risk for RA. Not all arthralgia patients are similar, and the type of arthralgia that is the hallmark for a heightened risk of progression to RA had not been defined formally prior to the EULAR definition.
A EULAR task force sought to provide some objective clarity by defining arthralgia at risk for RA (Ann Rheum Dis. 2017;76:491-6). The process relied on clinical expertise at all stages. However, until now, the definition had not been validated longitudinally. The current study used progression from arthralgia to clinical arthritis or RA as the outcome.
The definition of arthralgia at risk for RA hinges on seven parameters: symptom duration less than 1 year, symptoms in metacarpophalangeal joints, morning stiffness lasting an hour or more, symptoms that are worst in the morning, family history of RA, difficulty forming a fist, and positive squeeze test of metacarpophalangeal joints.
The researchers used those seven parameters to follow 241 Dutch patients considered likely to develop RA and 113 patients with recent-onset arthralgia in small joints who had not been evaluated by rheumatologists and who were referred to secondary care.
“The EULAR definition was developed for use in scientific studies and this definition is immediately applicable for this purpose,” Dr. van der Helm–van Mil said.
“With regards to application in daily practice, the clinical definition should be combined with results of additional investigations to accurately identify imminent RA in the phase of arthralgia. Which combination of markers yields the best accuracy is a subject for further studies,” Dr. van der Helm–van Mil said.
An important aspect of the task force’s definition is that rheumatologists should use it in patients in whom they consider imminent RA more likely than other diagnoses. The definition was not discriminative for RA when the investigators of the current study ignored this entry criterion, leading to a sensitivity of just 10% and positive predictive value of 3%.
“This suggests that the definition should be used in secondary care but may not be useful in primary care. However, more research is needed here,” Dr. van der Helm–van Mil said.
The authors reported no disclosures of interest.
FROM THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Patients clinically suspected of arthralgia who met the EULAR definition were twice as likely to develop RA at 2 years than were those who did not meet the definition (hazard ratio, 2.1; 95% confidence interval, 0.9–4.7).
Data source: Longitudinal study of 241 patients considered likely to develop RA and 113 patients with recent-onset arthralgia in small joints who had not been evaluated by rheumatologists and who were referred to secondary care.
Disclosures: The authors reported no disclosures of interest.
Dacomitinib boosts PFS in advanced NSCLC
CHICAGO – The clear advantage goes to the second-generation tyrosine kinase inhibitor in a new trial comparing dacomitinib to gefitinib for advanced non–small cell lung cancer.
In a randomized, open-label phase III trial designed as a head-to-head comparison of the two drugs for the first-line treatment of advanced non–small cell lung cancer (NSCLC), “the blinded, independent review showed that we have a median progression-free survival (PFS) of 14.7 months versus 9.2 months,” said first author Tony Mok, MD, professor and chair of the department of clinical oncology at the Chinese University of Hong Kong. This PFS rate, he said, “is among the highest of randomized phase III trials in the first-line setting.”
Two years into the study, those taking dacomitinib had triple the PFS rate of those on gefitinib (30.6% versus 9.6%). The overall hazard ratio (HR) for PFS with dacomitinib compared to gefitinib was 0.59 (95% confidence interval [CI], 0.47-0.74, P less than .0001).
A previous single-arm phase II trial of the drug, ARCHER 2017, showed a response rate of 75.6% and a median PFS of 18.2 months for patients with NSCLC and an EGFR-activating mutation.
“Based on these data, we thought it was likely that we could have a hypothesis for dacomitinib to be superior to gefitinib, a first-generation TKI [tyrosine kinase inhibitor], in terms of progression-free survival,” Dr. Mok said in a press conference at the annual meeting of the American Society of Clinical Oncology. Dacomitinib is a second-generation TKI.
Patients in the new study, ARCHER 1050, had advanced NSCLC with EGFR-activating mutations and no prior systemic treatment for their advanced disease. In addition, patients had good performance status, could not have had prior TKI exposure, and could not have CNS metastases. This last exclusion, explained Dr. Mok, was because investigators were uncertain about dacomitinib’s CNS penetration at the time of study design, and because gefitinib may also not be the best therapeutic choice for CNS metastases.
Patients were randomized 1:1 to receive either dacomitinib 45 mg orally daily (n = 227), or gefitinib 250 mg orally daily (n = 225). Patients were stratified by whether or not they were ethnically Asian, and by whether they had EGFR mutation of exon 19 or exon 21. Patients were balanced in terms of age, gender, ethnicity, smoking, and performance status between arms. About 75% of the patients were Asian, and 65% were nonsmokers.
The international study enrolled patients from 71 centers in Asia and Europe. At the time of the data cutoff, investigators saw PFS events totaling 59.9% in the dacomitinib arm and 79.6% in the gefitinib arm. Patients were followed for PFS for a median of 22.1 months. “We have relatively mature data,” said Dr. Mok, except for overall survival, with only 36.9% of events occurring at the time of the data cutoff.
The primary endpoint in the open-label trial was PFS in the intention-to-treat population, as assessed by an independent, blinded reviewer. Dr. Mok said that the study was powered to see at least 256 PFS events, and to see an improvement in PFS for dacomitinib that equated to an HR of no more than 0.667. This would translate to median PFS for dacomitinib of 14.3 months versus 9.5 months for gefitinib, values Dr. Mok said were “reasonable.” And, he pointed out, the study results fell almost exactly in line with these predictions, though the actual HR was a bit lower than predicted.
An analysis of PFS by subgroup, also conducted by independent review, found that dacomitinib was favored for all subgroups except for non-Asian patients, for whom the HR was 0.89 but did not reach statistical significance. Since these patients made up about one-fourth of the study population, said Dr. Mok, small sample size was a potential issue. “But we have to ask ourselves the question, do they really perform worse than the Asians, if they have a response?”
To attempt to answer this question, the investigators performed an exploratory analysis of the 72 non-Asian patients who had responded to therapy. Among this group, they saw data similar to that of the overall group, with an HR of 0.547 (95% CI, 0.321-0.933, P less than .0123).
Secondary endpoints included investigator-assessed PFS, overall survival, objective response rate, duration of response, quality of life, and safety assessments.
Objective response rates were similar between arms, at 74.9% for dacomitinib and 71.6% for gefitinib (P = .3883). However, the median duration of response was significantly longer for those on dacomitinib (14.8 versus 8.3 months, P less than .0001).
“This may be best explained by looking into the depth of the response,” said Dr. Mok. Patient-level data showed that dacomitinib patients had a larger reduction in target lesion size; “this may reflect a more potent inhibition of EGFR,” he said.
With the more potent inhibition, however, came more frequent grade 3 adverse events involving diarrhea, dermatitis, stomatitis, and paronychia for those on dacomitinib; however, noted Dr. Mok, serious transaminase elevations were more common in the gefitinib group. “There is no new signal” for concerning toxicity, he said. Dose reductions were more common in dacomitinib than in gefitinib (66.1% versus 18%), but there are two tiers of dose reductions permissible with dacomitinib, giving some flexibility.
Dr. Mok reported financial relationships with multiple pharmaceutical companies, including Pfizer and SFJ Pharmaceuticals, which sponsored the study.
[email protected]
On Twitter @karioakes
CHICAGO – The clear advantage goes to the second-generation tyrosine kinase inhibitor in a new trial comparing dacomitinib to gefitinib for advanced non–small cell lung cancer.
In a randomized, open-label phase III trial designed as a head-to-head comparison of the two drugs for the first-line treatment of advanced non–small cell lung cancer (NSCLC), “the blinded, independent review showed that we have a median progression-free survival (PFS) of 14.7 months versus 9.2 months,” said first author Tony Mok, MD, professor and chair of the department of clinical oncology at the Chinese University of Hong Kong. This PFS rate, he said, “is among the highest of randomized phase III trials in the first-line setting.”
Two years into the study, those taking dacomitinib had triple the PFS rate of those on gefitinib (30.6% versus 9.6%). The overall hazard ratio (HR) for PFS with dacomitinib compared to gefitinib was 0.59 (95% confidence interval [CI], 0.47-0.74, P less than .0001).
A previous single-arm phase II trial of the drug, ARCHER 2017, showed a response rate of 75.6% and a median PFS of 18.2 months for patients with NSCLC and an EGFR-activating mutation.
“Based on these data, we thought it was likely that we could have a hypothesis for dacomitinib to be superior to gefitinib, a first-generation TKI [tyrosine kinase inhibitor], in terms of progression-free survival,” Dr. Mok said in a press conference at the annual meeting of the American Society of Clinical Oncology. Dacomitinib is a second-generation TKI.
Patients in the new study, ARCHER 1050, had advanced NSCLC with EGFR-activating mutations and no prior systemic treatment for their advanced disease. In addition, patients had good performance status, could not have had prior TKI exposure, and could not have CNS metastases. This last exclusion, explained Dr. Mok, was because investigators were uncertain about dacomitinib’s CNS penetration at the time of study design, and because gefitinib may also not be the best therapeutic choice for CNS metastases.
Patients were randomized 1:1 to receive either dacomitinib 45 mg orally daily (n = 227), or gefitinib 250 mg orally daily (n = 225). Patients were stratified by whether or not they were ethnically Asian, and by whether they had EGFR mutation of exon 19 or exon 21. Patients were balanced in terms of age, gender, ethnicity, smoking, and performance status between arms. About 75% of the patients were Asian, and 65% were nonsmokers.
The international study enrolled patients from 71 centers in Asia and Europe. At the time of the data cutoff, investigators saw PFS events totaling 59.9% in the dacomitinib arm and 79.6% in the gefitinib arm. Patients were followed for PFS for a median of 22.1 months. “We have relatively mature data,” said Dr. Mok, except for overall survival, with only 36.9% of events occurring at the time of the data cutoff.
The primary endpoint in the open-label trial was PFS in the intention-to-treat population, as assessed by an independent, blinded reviewer. Dr. Mok said that the study was powered to see at least 256 PFS events, and to see an improvement in PFS for dacomitinib that equated to an HR of no more than 0.667. This would translate to median PFS for dacomitinib of 14.3 months versus 9.5 months for gefitinib, values Dr. Mok said were “reasonable.” And, he pointed out, the study results fell almost exactly in line with these predictions, though the actual HR was a bit lower than predicted.
An analysis of PFS by subgroup, also conducted by independent review, found that dacomitinib was favored for all subgroups except for non-Asian patients, for whom the HR was 0.89 but did not reach statistical significance. Since these patients made up about one-fourth of the study population, said Dr. Mok, small sample size was a potential issue. “But we have to ask ourselves the question, do they really perform worse than the Asians, if they have a response?”
To attempt to answer this question, the investigators performed an exploratory analysis of the 72 non-Asian patients who had responded to therapy. Among this group, they saw data similar to that of the overall group, with an HR of 0.547 (95% CI, 0.321-0.933, P less than .0123).
Secondary endpoints included investigator-assessed PFS, overall survival, objective response rate, duration of response, quality of life, and safety assessments.
Objective response rates were similar between arms, at 74.9% for dacomitinib and 71.6% for gefitinib (P = .3883). However, the median duration of response was significantly longer for those on dacomitinib (14.8 versus 8.3 months, P less than .0001).
“This may be best explained by looking into the depth of the response,” said Dr. Mok. Patient-level data showed that dacomitinib patients had a larger reduction in target lesion size; “this may reflect a more potent inhibition of EGFR,” he said.
With the more potent inhibition, however, came more frequent grade 3 adverse events involving diarrhea, dermatitis, stomatitis, and paronychia for those on dacomitinib; however, noted Dr. Mok, serious transaminase elevations were more common in the gefitinib group. “There is no new signal” for concerning toxicity, he said. Dose reductions were more common in dacomitinib than in gefitinib (66.1% versus 18%), but there are two tiers of dose reductions permissible with dacomitinib, giving some flexibility.
Dr. Mok reported financial relationships with multiple pharmaceutical companies, including Pfizer and SFJ Pharmaceuticals, which sponsored the study.
[email protected]
On Twitter @karioakes
CHICAGO – The clear advantage goes to the second-generation tyrosine kinase inhibitor in a new trial comparing dacomitinib to gefitinib for advanced non–small cell lung cancer.
In a randomized, open-label phase III trial designed as a head-to-head comparison of the two drugs for the first-line treatment of advanced non–small cell lung cancer (NSCLC), “the blinded, independent review showed that we have a median progression-free survival (PFS) of 14.7 months versus 9.2 months,” said first author Tony Mok, MD, professor and chair of the department of clinical oncology at the Chinese University of Hong Kong. This PFS rate, he said, “is among the highest of randomized phase III trials in the first-line setting.”
Two years into the study, those taking dacomitinib had triple the PFS rate of those on gefitinib (30.6% versus 9.6%). The overall hazard ratio (HR) for PFS with dacomitinib compared to gefitinib was 0.59 (95% confidence interval [CI], 0.47-0.74, P less than .0001).
A previous single-arm phase II trial of the drug, ARCHER 2017, showed a response rate of 75.6% and a median PFS of 18.2 months for patients with NSCLC and an EGFR-activating mutation.
“Based on these data, we thought it was likely that we could have a hypothesis for dacomitinib to be superior to gefitinib, a first-generation TKI [tyrosine kinase inhibitor], in terms of progression-free survival,” Dr. Mok said in a press conference at the annual meeting of the American Society of Clinical Oncology. Dacomitinib is a second-generation TKI.
Patients in the new study, ARCHER 1050, had advanced NSCLC with EGFR-activating mutations and no prior systemic treatment for their advanced disease. In addition, patients had good performance status, could not have had prior TKI exposure, and could not have CNS metastases. This last exclusion, explained Dr. Mok, was because investigators were uncertain about dacomitinib’s CNS penetration at the time of study design, and because gefitinib may also not be the best therapeutic choice for CNS metastases.
Patients were randomized 1:1 to receive either dacomitinib 45 mg orally daily (n = 227), or gefitinib 250 mg orally daily (n = 225). Patients were stratified by whether or not they were ethnically Asian, and by whether they had EGFR mutation of exon 19 or exon 21. Patients were balanced in terms of age, gender, ethnicity, smoking, and performance status between arms. About 75% of the patients were Asian, and 65% were nonsmokers.
The international study enrolled patients from 71 centers in Asia and Europe. At the time of the data cutoff, investigators saw PFS events totaling 59.9% in the dacomitinib arm and 79.6% in the gefitinib arm. Patients were followed for PFS for a median of 22.1 months. “We have relatively mature data,” said Dr. Mok, except for overall survival, with only 36.9% of events occurring at the time of the data cutoff.
The primary endpoint in the open-label trial was PFS in the intention-to-treat population, as assessed by an independent, blinded reviewer. Dr. Mok said that the study was powered to see at least 256 PFS events, and to see an improvement in PFS for dacomitinib that equated to an HR of no more than 0.667. This would translate to median PFS for dacomitinib of 14.3 months versus 9.5 months for gefitinib, values Dr. Mok said were “reasonable.” And, he pointed out, the study results fell almost exactly in line with these predictions, though the actual HR was a bit lower than predicted.
An analysis of PFS by subgroup, also conducted by independent review, found that dacomitinib was favored for all subgroups except for non-Asian patients, for whom the HR was 0.89 but did not reach statistical significance. Since these patients made up about one-fourth of the study population, said Dr. Mok, small sample size was a potential issue. “But we have to ask ourselves the question, do they really perform worse than the Asians, if they have a response?”
To attempt to answer this question, the investigators performed an exploratory analysis of the 72 non-Asian patients who had responded to therapy. Among this group, they saw data similar to that of the overall group, with an HR of 0.547 (95% CI, 0.321-0.933, P less than .0123).
Secondary endpoints included investigator-assessed PFS, overall survival, objective response rate, duration of response, quality of life, and safety assessments.
Objective response rates were similar between arms, at 74.9% for dacomitinib and 71.6% for gefitinib (P = .3883). However, the median duration of response was significantly longer for those on dacomitinib (14.8 versus 8.3 months, P less than .0001).
“This may be best explained by looking into the depth of the response,” said Dr. Mok. Patient-level data showed that dacomitinib patients had a larger reduction in target lesion size; “this may reflect a more potent inhibition of EGFR,” he said.
With the more potent inhibition, however, came more frequent grade 3 adverse events involving diarrhea, dermatitis, stomatitis, and paronychia for those on dacomitinib; however, noted Dr. Mok, serious transaminase elevations were more common in the gefitinib group. “There is no new signal” for concerning toxicity, he said. Dose reductions were more common in dacomitinib than in gefitinib (66.1% versus 18%), but there are two tiers of dose reductions permissible with dacomitinib, giving some flexibility.
Dr. Mok reported financial relationships with multiple pharmaceutical companies, including Pfizer and SFJ Pharmaceuticals, which sponsored the study.
[email protected]
On Twitter @karioakes
AT ASCO 2017
Key clinical point:
Major finding: At 2 years, the dacomitinib arm had triple the PFS rate of the gefitinib arm (30.6% versus 9.6%).
Data source: Randomized, open-label phase III clinical trial of 452 patients who received dacomitinib or gefitinib for first-line therapy for advanced non–small cell lung cancer.
Disclosures: Dr. Mok reported financial relationships with multiple pharmaceutical companies, including Pfizer and SFJ Pharmaceuticals, which funded the study.
Add-on tofacitinib as good as adalimumab for active RA
MADRID – When it comes to patients with rheumatoid arthritis who are responding inadequately to methotrexate therapy, results of the Oral Rheumatoid Arthritis triaL (ORAL) Strategy study suggest that adding the Janus kinase inhibitor tofacitinib is just as effective as adding the tumor necrosis factor inhibitor adalimumab.
At 6 months’ follow-up, 46% of patients randomized to tofacitinib (Xeljanz) plus methotrexate met the trial’s primary endpoint of an American College of Rheumatology response of at least 50% (ACR50), compared with 44% of those who were given adalimumab (Humira) plus methotrexate. This result met the trial’s prespecified criteria for noninferiority. An ACR50 response means that there was at least 50% improvement in tender or swollen joint counts as well as a 50% improvement in at least three of the other five criteria (acute phase reactant, such as erythrocyte sedimentation rate; patient assessment; physician assessment; pain scale; and disability/functional questionnaire).
Nevertheless, “in circumstances where methotrexate is precluded, tofacitinib monotherapy is a clinically viable option,” lead study author Roy Fleischmann, MD, said at the European Congress of Rheumatology.
“This actually substantiates what I’ve done in clinical practice since [tofacitinib] was approved,” said Dr. Fleischmann, a rheumatologist in group practice in Dallas. “If I have patients on methotrexate and they show an incomplete response, I add tofacitinib; I don’t switch, I add. Then if the patient has a good response – a really good response – then I discontinue [methotrexate].”
Dr. Fleischmann said he does the same when adding a tumor necrosis factor inhibitor to methotrexate and that there are some patients who just do better with combination treatment.
ORAL Strategy was a phase IIIB/IV study that randomized 1,152 adults with active RA, despite treatment for more than 4 months with 15-25 mg/kg of methotrexate per week. Patients had to have four or more painful or tender joints and four or more swollen joints at baseline, and a high-sensitivity C-reactive protein level of 3 mg/L or more.
Patients were randomized to one of the study’s three treatment arms: tofacitinib 5 mg twice daily as monotherapy (n = 384), the same regimen of tofacitinib added to methotrexate (n = 376), or adalimumab 40 mg every 2 weeks added to methotrexate (n = 386). (Two patients in each group did not receive their assigned treatment.) Treatment was for 1 year, and concomitant treatment with nonsteroidal anti-inflammatory drugs, oral glucocorticoids, or both was allowed so long as their doses remained stable and no dose adjustments were necessary.
ACR20 responses were also recorded and were achieved by 65% with tofacitinib monotherapy, 73% with tofacitinib plus methotrexate, and 71% with adalimumab plus methotrexate, and ACR70 responses were 18%, 25%, and 21%, respectively. Comparable improvements from baseline to the end of the study were also seen for Simple Disease Activity Index, Clinical Disease Activity Index, Disease Activity Score in 28 joints using erythrocyte sedimentation rate, and Health Assessment Questionnaire scores in patients given the combination treatments.
The study’s findings were published online (Lancet. 2017 Jun 16. doi: 10.1016/S0140-6736[17]31618-5) to coincide with their presentation in a late-breaking abstract at the meeting.
“The ORAL Strategy trial highlights three benefits from the combination of tofacitinib and methotrexate in active rheumatoid arthritis,” independent commentators David Scott, MD, and Matt D. Stevenson, PhD, wrote in an editorial (Lancet. 2017 Jun 16. doi: 10.1016/S0140-6736[17]31659-8).
“First, this combination’s efficacy and toxicity are similar to injectable biologics such as adalimumab,” said Dr. Scott of King’s College London and Dr. Stevenson of the University of Sheffield (England). Indeed, no new side effects were seen, and side effects were consistent with those seen in previous studies.
“Second,” they wrote, “the onset of action of these drugs seems equally rapid. Third, most patients are able to remain on tofacitinib therapy for 12 months.”
Dr. Scott and Dr. Stevenson suggested these findings are “extremely encouraging” as “they show the ongoing benefits of innovation in drug treatment.”
The findings support the previous RA-BEAM trial (N Engl J Med. 2017;376:652-62) with another Janus kinase inhibitor, baricitinib, Dr. Fleischmann said during his presentation, which had also shown combination therapy with methotrexate was perhaps more beneficial than adding adalimumab.
In the Lancet editorial, Dr. Scott and Dr. Stevenson wrote: “Although a combination of [Janus kinase] inhibitors with methotrexate is likely to be the way they are used in clinical practice, monotherapy results in clinical and functional responses, as shown in the ORAL Strategy trial, and thus might be appropriate in some patients.”
The study was funded by Pfizer. Dr. Fleischmann has received research grants, research support, and consultancy fees from Pfizer and from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Sanofi-Genzyme, and UCB. Dr. Scott has advised Eli Lilly, Roche Products, Napp Pharmaceuticals, Baxalta, and Novartis. Dr. Stevenson did not have any industry disclosures.
MADRID – When it comes to patients with rheumatoid arthritis who are responding inadequately to methotrexate therapy, results of the Oral Rheumatoid Arthritis triaL (ORAL) Strategy study suggest that adding the Janus kinase inhibitor tofacitinib is just as effective as adding the tumor necrosis factor inhibitor adalimumab.
At 6 months’ follow-up, 46% of patients randomized to tofacitinib (Xeljanz) plus methotrexate met the trial’s primary endpoint of an American College of Rheumatology response of at least 50% (ACR50), compared with 44% of those who were given adalimumab (Humira) plus methotrexate. This result met the trial’s prespecified criteria for noninferiority. An ACR50 response means that there was at least 50% improvement in tender or swollen joint counts as well as a 50% improvement in at least three of the other five criteria (acute phase reactant, such as erythrocyte sedimentation rate; patient assessment; physician assessment; pain scale; and disability/functional questionnaire).
Nevertheless, “in circumstances where methotrexate is precluded, tofacitinib monotherapy is a clinically viable option,” lead study author Roy Fleischmann, MD, said at the European Congress of Rheumatology.
“This actually substantiates what I’ve done in clinical practice since [tofacitinib] was approved,” said Dr. Fleischmann, a rheumatologist in group practice in Dallas. “If I have patients on methotrexate and they show an incomplete response, I add tofacitinib; I don’t switch, I add. Then if the patient has a good response – a really good response – then I discontinue [methotrexate].”
Dr. Fleischmann said he does the same when adding a tumor necrosis factor inhibitor to methotrexate and that there are some patients who just do better with combination treatment.
ORAL Strategy was a phase IIIB/IV study that randomized 1,152 adults with active RA, despite treatment for more than 4 months with 15-25 mg/kg of methotrexate per week. Patients had to have four or more painful or tender joints and four or more swollen joints at baseline, and a high-sensitivity C-reactive protein level of 3 mg/L or more.
Patients were randomized to one of the study’s three treatment arms: tofacitinib 5 mg twice daily as monotherapy (n = 384), the same regimen of tofacitinib added to methotrexate (n = 376), or adalimumab 40 mg every 2 weeks added to methotrexate (n = 386). (Two patients in each group did not receive their assigned treatment.) Treatment was for 1 year, and concomitant treatment with nonsteroidal anti-inflammatory drugs, oral glucocorticoids, or both was allowed so long as their doses remained stable and no dose adjustments were necessary.
ACR20 responses were also recorded and were achieved by 65% with tofacitinib monotherapy, 73% with tofacitinib plus methotrexate, and 71% with adalimumab plus methotrexate, and ACR70 responses were 18%, 25%, and 21%, respectively. Comparable improvements from baseline to the end of the study were also seen for Simple Disease Activity Index, Clinical Disease Activity Index, Disease Activity Score in 28 joints using erythrocyte sedimentation rate, and Health Assessment Questionnaire scores in patients given the combination treatments.
The study’s findings were published online (Lancet. 2017 Jun 16. doi: 10.1016/S0140-6736[17]31618-5) to coincide with their presentation in a late-breaking abstract at the meeting.
“The ORAL Strategy trial highlights three benefits from the combination of tofacitinib and methotrexate in active rheumatoid arthritis,” independent commentators David Scott, MD, and Matt D. Stevenson, PhD, wrote in an editorial (Lancet. 2017 Jun 16. doi: 10.1016/S0140-6736[17]31659-8).
“First, this combination’s efficacy and toxicity are similar to injectable biologics such as adalimumab,” said Dr. Scott of King’s College London and Dr. Stevenson of the University of Sheffield (England). Indeed, no new side effects were seen, and side effects were consistent with those seen in previous studies.
“Second,” they wrote, “the onset of action of these drugs seems equally rapid. Third, most patients are able to remain on tofacitinib therapy for 12 months.”
Dr. Scott and Dr. Stevenson suggested these findings are “extremely encouraging” as “they show the ongoing benefits of innovation in drug treatment.”
The findings support the previous RA-BEAM trial (N Engl J Med. 2017;376:652-62) with another Janus kinase inhibitor, baricitinib, Dr. Fleischmann said during his presentation, which had also shown combination therapy with methotrexate was perhaps more beneficial than adding adalimumab.
In the Lancet editorial, Dr. Scott and Dr. Stevenson wrote: “Although a combination of [Janus kinase] inhibitors with methotrexate is likely to be the way they are used in clinical practice, monotherapy results in clinical and functional responses, as shown in the ORAL Strategy trial, and thus might be appropriate in some patients.”
The study was funded by Pfizer. Dr. Fleischmann has received research grants, research support, and consultancy fees from Pfizer and from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Sanofi-Genzyme, and UCB. Dr. Scott has advised Eli Lilly, Roche Products, Napp Pharmaceuticals, Baxalta, and Novartis. Dr. Stevenson did not have any industry disclosures.
MADRID – When it comes to patients with rheumatoid arthritis who are responding inadequately to methotrexate therapy, results of the Oral Rheumatoid Arthritis triaL (ORAL) Strategy study suggest that adding the Janus kinase inhibitor tofacitinib is just as effective as adding the tumor necrosis factor inhibitor adalimumab.
At 6 months’ follow-up, 46% of patients randomized to tofacitinib (Xeljanz) plus methotrexate met the trial’s primary endpoint of an American College of Rheumatology response of at least 50% (ACR50), compared with 44% of those who were given adalimumab (Humira) plus methotrexate. This result met the trial’s prespecified criteria for noninferiority. An ACR50 response means that there was at least 50% improvement in tender or swollen joint counts as well as a 50% improvement in at least three of the other five criteria (acute phase reactant, such as erythrocyte sedimentation rate; patient assessment; physician assessment; pain scale; and disability/functional questionnaire).
Nevertheless, “in circumstances where methotrexate is precluded, tofacitinib monotherapy is a clinically viable option,” lead study author Roy Fleischmann, MD, said at the European Congress of Rheumatology.
“This actually substantiates what I’ve done in clinical practice since [tofacitinib] was approved,” said Dr. Fleischmann, a rheumatologist in group practice in Dallas. “If I have patients on methotrexate and they show an incomplete response, I add tofacitinib; I don’t switch, I add. Then if the patient has a good response – a really good response – then I discontinue [methotrexate].”
Dr. Fleischmann said he does the same when adding a tumor necrosis factor inhibitor to methotrexate and that there are some patients who just do better with combination treatment.
ORAL Strategy was a phase IIIB/IV study that randomized 1,152 adults with active RA, despite treatment for more than 4 months with 15-25 mg/kg of methotrexate per week. Patients had to have four or more painful or tender joints and four or more swollen joints at baseline, and a high-sensitivity C-reactive protein level of 3 mg/L or more.
Patients were randomized to one of the study’s three treatment arms: tofacitinib 5 mg twice daily as monotherapy (n = 384), the same regimen of tofacitinib added to methotrexate (n = 376), or adalimumab 40 mg every 2 weeks added to methotrexate (n = 386). (Two patients in each group did not receive their assigned treatment.) Treatment was for 1 year, and concomitant treatment with nonsteroidal anti-inflammatory drugs, oral glucocorticoids, or both was allowed so long as their doses remained stable and no dose adjustments were necessary.
ACR20 responses were also recorded and were achieved by 65% with tofacitinib monotherapy, 73% with tofacitinib plus methotrexate, and 71% with adalimumab plus methotrexate, and ACR70 responses were 18%, 25%, and 21%, respectively. Comparable improvements from baseline to the end of the study were also seen for Simple Disease Activity Index, Clinical Disease Activity Index, Disease Activity Score in 28 joints using erythrocyte sedimentation rate, and Health Assessment Questionnaire scores in patients given the combination treatments.
The study’s findings were published online (Lancet. 2017 Jun 16. doi: 10.1016/S0140-6736[17]31618-5) to coincide with their presentation in a late-breaking abstract at the meeting.
“The ORAL Strategy trial highlights three benefits from the combination of tofacitinib and methotrexate in active rheumatoid arthritis,” independent commentators David Scott, MD, and Matt D. Stevenson, PhD, wrote in an editorial (Lancet. 2017 Jun 16. doi: 10.1016/S0140-6736[17]31659-8).
“First, this combination’s efficacy and toxicity are similar to injectable biologics such as adalimumab,” said Dr. Scott of King’s College London and Dr. Stevenson of the University of Sheffield (England). Indeed, no new side effects were seen, and side effects were consistent with those seen in previous studies.
“Second,” they wrote, “the onset of action of these drugs seems equally rapid. Third, most patients are able to remain on tofacitinib therapy for 12 months.”
Dr. Scott and Dr. Stevenson suggested these findings are “extremely encouraging” as “they show the ongoing benefits of innovation in drug treatment.”
The findings support the previous RA-BEAM trial (N Engl J Med. 2017;376:652-62) with another Janus kinase inhibitor, baricitinib, Dr. Fleischmann said during his presentation, which had also shown combination therapy with methotrexate was perhaps more beneficial than adding adalimumab.
In the Lancet editorial, Dr. Scott and Dr. Stevenson wrote: “Although a combination of [Janus kinase] inhibitors with methotrexate is likely to be the way they are used in clinical practice, monotherapy results in clinical and functional responses, as shown in the ORAL Strategy trial, and thus might be appropriate in some patients.”
The study was funded by Pfizer. Dr. Fleischmann has received research grants, research support, and consultancy fees from Pfizer and from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Sanofi-Genzyme, and UCB. Dr. Scott has advised Eli Lilly, Roche Products, Napp Pharmaceuticals, Baxalta, and Novartis. Dr. Stevenson did not have any industry disclosures.
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: The primary endpoint of an ACR50 was met by 46% of patients randomized to tofacitinib plus methotrexate vs. 44% of those who were given adalimumab plus methotrexate. This result met the trial’s prespecified criteria for noninferiority.
Data source: ORAL Strategy: A phase IIIB/IV, double-blind, head-to-head, noninferiority, randomized, controlled trial of tofacitinib with or without methotrexate, and adalimumab with methotrexate, in 1,152 RA patients inadequately responding to methotrexate.
Disclosures: The study was funded by Pfizer. The study presenter has received research grants, research support, and consultancy fees from Pfizer and from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Sanofi-Genzyme, and UCB. One independent commentator has advised Eli Lilly, Roche Products, Napp Pharmaceuticals, Baxalta, and Novartis, while the other did not have any industry disclosures.
Adoptions increasingly involve special needs, prenatal drug exposures
SAN FRANCISCO – International adoptions today almost exclusively involve children with special needs, and domestic adoptions are far more likely to involve children exposed prenatally to marijuana, opiates, or another drug, Lisa Prock, MD, MPH, found in a study.
“Pediatric health care providers reviewing referrals for adoption should be knowledgeable about the changing demographics of this population and the long-term implications of prenatal substance exposure, given increasing opiate and marijuana use nationally,” said Dr. Prock of Boston Children’s Hospital.
During the initial flood of international adoptions in the 1990s, families sought preadoption consultations, often centering on infectious disease, at an increasing number of adoption clinics. Even with the decline of international adoptions, however, prospective parents still frequently seek information from pediatric providers about children they are considering adopting, whether internationally or domestically.
Prospective parents can receive medical record reviews of children they are considering adopting, provided by adoption agencies or attorneys. Dr. Prock retrospectively reviewed all the preadoptive charts submitted to one adoption clinic during 2 years a decade apart: 63 charts in 2006 and 91 charts in 2016.
Domestic records for both years usually included information about family history, prenatal history, maternal substance abuse history, lab results, and, for newborns, a physical exam. International records, however, generally included only lab results and a physical exam, sometimes with limited information on substance abuse as well, at both time points.
The records reveal just how dramatically referrals have flipped from an international focus to a domestic one in the past decade. International adoption referrals dropped from 84% in 2006 to 29% in 2016 as domestic ones increased from 16% to 71%.
Children with special needs also account for a larger proportion of all adoption referrals today. Just a quarter of international adoption referrals in 2006 involved children with special needs, including cleft lip and/or palate and congenital heart disease, but nearly all international referrals (96%) involved special needs in 2016.
Similarly, domestic adoption referrals in which the child is known to have prenatal exposure to alcohol or drugs doubled from 30% in 2006 to 66% in 2016, driven predominantly by maternal use of marijuana and opiates, Dr. Prock found. It’s important both for providers and for prospective parents to be aware of the higher likelihood that an internationally adopted child will have significant medical and/or developmental needs and that domestically adopted children are more likely to have experienced prenatal drug or alcohol exposures.
“Prospective adoptive parents may benefit from increased understanding of the long-term impact of prenatal substance exposure to marijuana, opiates and other substances,” Dr. Prock said. She also noted the need for prospective parents to be aware of the mental health concerns that can co-occur with substance use even though they may not be reported in preadoptive medical records.
No external funding was used for the research. Dr. Prock had no relevant financial disclosures.
SAN FRANCISCO – International adoptions today almost exclusively involve children with special needs, and domestic adoptions are far more likely to involve children exposed prenatally to marijuana, opiates, or another drug, Lisa Prock, MD, MPH, found in a study.
“Pediatric health care providers reviewing referrals for adoption should be knowledgeable about the changing demographics of this population and the long-term implications of prenatal substance exposure, given increasing opiate and marijuana use nationally,” said Dr. Prock of Boston Children’s Hospital.
During the initial flood of international adoptions in the 1990s, families sought preadoption consultations, often centering on infectious disease, at an increasing number of adoption clinics. Even with the decline of international adoptions, however, prospective parents still frequently seek information from pediatric providers about children they are considering adopting, whether internationally or domestically.
Prospective parents can receive medical record reviews of children they are considering adopting, provided by adoption agencies or attorneys. Dr. Prock retrospectively reviewed all the preadoptive charts submitted to one adoption clinic during 2 years a decade apart: 63 charts in 2006 and 91 charts in 2016.
Domestic records for both years usually included information about family history, prenatal history, maternal substance abuse history, lab results, and, for newborns, a physical exam. International records, however, generally included only lab results and a physical exam, sometimes with limited information on substance abuse as well, at both time points.
The records reveal just how dramatically referrals have flipped from an international focus to a domestic one in the past decade. International adoption referrals dropped from 84% in 2006 to 29% in 2016 as domestic ones increased from 16% to 71%.
Children with special needs also account for a larger proportion of all adoption referrals today. Just a quarter of international adoption referrals in 2006 involved children with special needs, including cleft lip and/or palate and congenital heart disease, but nearly all international referrals (96%) involved special needs in 2016.
Similarly, domestic adoption referrals in which the child is known to have prenatal exposure to alcohol or drugs doubled from 30% in 2006 to 66% in 2016, driven predominantly by maternal use of marijuana and opiates, Dr. Prock found. It’s important both for providers and for prospective parents to be aware of the higher likelihood that an internationally adopted child will have significant medical and/or developmental needs and that domestically adopted children are more likely to have experienced prenatal drug or alcohol exposures.
“Prospective adoptive parents may benefit from increased understanding of the long-term impact of prenatal substance exposure to marijuana, opiates and other substances,” Dr. Prock said. She also noted the need for prospective parents to be aware of the mental health concerns that can co-occur with substance use even though they may not be reported in preadoptive medical records.
No external funding was used for the research. Dr. Prock had no relevant financial disclosures.
SAN FRANCISCO – International adoptions today almost exclusively involve children with special needs, and domestic adoptions are far more likely to involve children exposed prenatally to marijuana, opiates, or another drug, Lisa Prock, MD, MPH, found in a study.
“Pediatric health care providers reviewing referrals for adoption should be knowledgeable about the changing demographics of this population and the long-term implications of prenatal substance exposure, given increasing opiate and marijuana use nationally,” said Dr. Prock of Boston Children’s Hospital.
During the initial flood of international adoptions in the 1990s, families sought preadoption consultations, often centering on infectious disease, at an increasing number of adoption clinics. Even with the decline of international adoptions, however, prospective parents still frequently seek information from pediatric providers about children they are considering adopting, whether internationally or domestically.
Prospective parents can receive medical record reviews of children they are considering adopting, provided by adoption agencies or attorneys. Dr. Prock retrospectively reviewed all the preadoptive charts submitted to one adoption clinic during 2 years a decade apart: 63 charts in 2006 and 91 charts in 2016.
Domestic records for both years usually included information about family history, prenatal history, maternal substance abuse history, lab results, and, for newborns, a physical exam. International records, however, generally included only lab results and a physical exam, sometimes with limited information on substance abuse as well, at both time points.
The records reveal just how dramatically referrals have flipped from an international focus to a domestic one in the past decade. International adoption referrals dropped from 84% in 2006 to 29% in 2016 as domestic ones increased from 16% to 71%.
Children with special needs also account for a larger proportion of all adoption referrals today. Just a quarter of international adoption referrals in 2006 involved children with special needs, including cleft lip and/or palate and congenital heart disease, but nearly all international referrals (96%) involved special needs in 2016.
Similarly, domestic adoption referrals in which the child is known to have prenatal exposure to alcohol or drugs doubled from 30% in 2006 to 66% in 2016, driven predominantly by maternal use of marijuana and opiates, Dr. Prock found. It’s important both for providers and for prospective parents to be aware of the higher likelihood that an internationally adopted child will have significant medical and/or developmental needs and that domestically adopted children are more likely to have experienced prenatal drug or alcohol exposures.
“Prospective adoptive parents may benefit from increased understanding of the long-term impact of prenatal substance exposure to marijuana, opiates and other substances,” Dr. Prock said. She also noted the need for prospective parents to be aware of the mental health concerns that can co-occur with substance use even though they may not be reported in preadoptive medical records.
No external funding was used for the research. Dr. Prock had no relevant financial disclosures.
AT PAS 17
Key clinical point:
Major finding: International adoption referrals with special needs increased from 25% to 96% from 2006 to 2016; domestic referrals with prenatal substance exposure increased from 30% to 66% over the same time period.
Data source: A retrospective review of all preadoptive medical records at a single adoption clinic in 2006 and 2016.
Disclosures: The researchers did not receive external funding. Dr. Prock had no relevant financial disclosures.
Sneak Peek: The Hospital Leader blog - July 2017
“We Are Not Done Changing”
Recently, the online version of JAMA published an original investigation titled, “Patient Mortality During Unannounced Accreditation Surveys at US Hospitals.” The purpose of this investigation was to determine the effect of heightened vigilance during unannounced accreditation surveys on safety and quality of inpatient care.
The authors found that there was a significant reduction in mortality in patients admitted during the week of surveys by The Joint Commission. The change was more significant in major teaching hospitals, where mortality fell from 6.41% to 5.93% during survey weeks, a 5.9% relative decrease. The positive effects of being monitored have been well documented in all kinds of arenas, such as hand washing and antibiotic stewardship. But mortality?
Overall, I feel like I’m a reasonable person, but the clear lack of interest – or willingness to consider that this might not be a good idea on the part of the hospitalist in charge – incited a certain amount of anger and disbelief in me. She also received an antibiotic that she had a documented allergy to – a clear medical error. I instructed my sis-in-law to refuse access to the line; it was removed, and she ultimately recovered to discharge.
This brings me back to the JAMA study. It’s easy to perceive unannounced inspections as merely an inconvenience, where things are locked up that normally aren’t, or where that coveted cup of coffee you normally bring on rounds to get you through your day is summarily yanked out of your hand.
Read the full text of this blog post at hospitalleader.org.
Also on The Hospital Leader…
• How Often Do You Ask This (Ineffective) Question? by Brad Flansbaum, DO, MPH, MHM• Building a Practice that People Want to Be a Part Of by Leslie Flores, MHA• A Need for Medicare Appeals Process Reform in Hospital Observation Care by Anne Sheehy, MD, MS, FHM
“We Are Not Done Changing”
Recently, the online version of JAMA published an original investigation titled, “Patient Mortality During Unannounced Accreditation Surveys at US Hospitals.” The purpose of this investigation was to determine the effect of heightened vigilance during unannounced accreditation surveys on safety and quality of inpatient care.
The authors found that there was a significant reduction in mortality in patients admitted during the week of surveys by The Joint Commission. The change was more significant in major teaching hospitals, where mortality fell from 6.41% to 5.93% during survey weeks, a 5.9% relative decrease. The positive effects of being monitored have been well documented in all kinds of arenas, such as hand washing and antibiotic stewardship. But mortality?
Overall, I feel like I’m a reasonable person, but the clear lack of interest – or willingness to consider that this might not be a good idea on the part of the hospitalist in charge – incited a certain amount of anger and disbelief in me. She also received an antibiotic that she had a documented allergy to – a clear medical error. I instructed my sis-in-law to refuse access to the line; it was removed, and she ultimately recovered to discharge.
This brings me back to the JAMA study. It’s easy to perceive unannounced inspections as merely an inconvenience, where things are locked up that normally aren’t, or where that coveted cup of coffee you normally bring on rounds to get you through your day is summarily yanked out of your hand.
Read the full text of this blog post at hospitalleader.org.
Also on The Hospital Leader…
• How Often Do You Ask This (Ineffective) Question? by Brad Flansbaum, DO, MPH, MHM• Building a Practice that People Want to Be a Part Of by Leslie Flores, MHA• A Need for Medicare Appeals Process Reform in Hospital Observation Care by Anne Sheehy, MD, MS, FHM
“We Are Not Done Changing”
Recently, the online version of JAMA published an original investigation titled, “Patient Mortality During Unannounced Accreditation Surveys at US Hospitals.” The purpose of this investigation was to determine the effect of heightened vigilance during unannounced accreditation surveys on safety and quality of inpatient care.
The authors found that there was a significant reduction in mortality in patients admitted during the week of surveys by The Joint Commission. The change was more significant in major teaching hospitals, where mortality fell from 6.41% to 5.93% during survey weeks, a 5.9% relative decrease. The positive effects of being monitored have been well documented in all kinds of arenas, such as hand washing and antibiotic stewardship. But mortality?
Overall, I feel like I’m a reasonable person, but the clear lack of interest – or willingness to consider that this might not be a good idea on the part of the hospitalist in charge – incited a certain amount of anger and disbelief in me. She also received an antibiotic that she had a documented allergy to – a clear medical error. I instructed my sis-in-law to refuse access to the line; it was removed, and she ultimately recovered to discharge.
This brings me back to the JAMA study. It’s easy to perceive unannounced inspections as merely an inconvenience, where things are locked up that normally aren’t, or where that coveted cup of coffee you normally bring on rounds to get you through your day is summarily yanked out of your hand.
Read the full text of this blog post at hospitalleader.org.
Also on The Hospital Leader…
• How Often Do You Ask This (Ineffective) Question? by Brad Flansbaum, DO, MPH, MHM• Building a Practice that People Want to Be a Part Of by Leslie Flores, MHA• A Need for Medicare Appeals Process Reform in Hospital Observation Care by Anne Sheehy, MD, MS, FHM
Health IT: Cybercrime risks are real
Aging equipment, valuable data, and an improperly trained workforce make health care IT extraordinarily vulnerable to external malfeasance, as demonstrated by the WannaCry virus episode that occurred this spring in the United Kingdom.
Computer hackers used a weakness in the operating system employed by the U.K. National Health Service, allowing the WannaCry virus to spread quickly across connected systems. The ransomware attack locked clinicians out of patient records and diagnostic machines that were connected, bringing patient care to a near standstill.
The attack lasted 3 days until Marcus Hutchins, a 22-year-old security researcher, stumbled onto a way to slow the spread of the virus enough to manage it, but not before nearly 60 million attacks had been conducted, Salim Neino, CEO of Kryptos Logic, testified June 15 at a joint hearing of two subcommittees of the House Science, Space & Technology Committee. Mr. Hutchins is employed by Kryptos Logic.
U.S. officials are keenly aware that a similar attack could happen here. In June, the federally sponsored Health Care Industry Cybersecurity Task Force issued a report on their year-long look at the state of the health care IT in this country. The task force was mandated by the Cybersecurity Act of 2015and formed in March 2016.
Specifically, the task force recommended:
• Defining and streamlining leadership, governance, and expectations for health care industry cybersecurity.
• Increasing the security and resilience of medical devices and health IT.
• Developing the health care workforce capacity necessary to prioritize and ensure cybersecurity awareness and technical capabilities.
• Increasing health care industry readiness through improved cybersecurity awareness and education.
• Identifying mechanisms to protect research and development efforts and intellectual property from attacks or exposure.
• Improving information sharing of industry threats, weaknesses, and mitigations.
Health care cybercrime is a significant problem in the United States. In 2016, 328 U.S. health care firms reported data breaches, up from 268 in 2015, with a total of 16.6 million Americans affected, according to a report conducted by Bitglass (registration required), a security software company. In February 2016, a hospital in California was forced to pay about $17,000 in Bitcoin, an electronic currency that is known to be favored by cybercriminals, to access electronic health records (EHRs) that were held in a similar manner to last month’s attack on the NHS.
For physicians, this may seem like someone else’s problem; however, unsafe day-to-day interactions with connected devices and patient EHRs were among the task force’s primary concerns.
For many, creating a safe password or not giving out critical information may seem like common sense, but many physicians are not able or willing to take the time to make sure they are interacting with systems safely, or they are overconfident in their security system, according to task force member Mark Jarrett, MD, senior vice president and chief quality officer at Northwell Health in New York.
“Most physicians now will try to access medical records of their patients who have been in the hospital because that’s good care,” Dr. Jarrett said in an interview. But they have to recognize that “they cannot give these passwords to other people and they need to make these passwords complex.”
“Phishing” is another concern. In a phishing scam, cybercriminals will pose as a fraudulent institution or individual in order to trick a target into downloading a virus, sending additional valuable information, or even paying money directly to the criminals.
“Physicians checking their emails need to be aware of possible phishing episodes, because they could be infected, and then there is the possibility that infection could be introduced into the system, Dr. Jarrett said. “I think the disconnect is [that physicians] are not used to [cybersecurity]. It’s not part of their daily life and they also, up until recently, thought ‘it’s never going to happen to me.’ ”
While hospitals are not completely incapable of protecting themselves, experts are concerned about an overinflated sense of confidence among health care professionals.
“Health care workers often assume that the IT network and the devices they support function efficiently and that their level of cybersecurity vulnerability is low,” according to the task force report.
This can be a costly assumption, financially, as well for safety; the price per stolen EHR averaged at $380 in 2016-2017, according to the Ponemon Institute’s 2017 Cost of Data Breach Study, released in June. That is nearly triple the average cost of all breaches – $141– and higher than the price of $241 for information stolen from financial industries because, unlike a credit card number, patients’ data are unique and cannot be replaced.
Aging equipment is another concern. Legacy software and machine systems used in medical practices and hospitals are not equipped with the necessary security services needed to handle the growing risks of connectivity, despite being included in the network.
“Every CT machine, every x-ray machine today is connected online, on one consolidated Internet” cybersecurity expert Idan Udi Edry of Trustifi said in an interview. “The more comfortable we are with the digital edge coming into our lives, the more vulnerable we become and the more security we need to implement to protect ourselves.”
Some solutions already have been suggested to help health care professionals replace their outdated equipment, especially private practice physicians or smaller hospitals without much financial wiggle room,
The cybersecurity task force report recommended creating health IT version of Cash for Clunkers, an Obama administration program that offered rebates to consumers who traded in older, less fuel efficient cars when purchasing a new car.
While experts agree that the growing focus on connected health care will continue to create cybersecurity risks, with all members of the health care industry working together, it is possible to keep hospitals and patients safe from would-be criminals.
The next key step is creating regulations that would encourage a cohesive structure of cybersecurity guidelines. According to the task force report, “a priority for regulatory agencies should be to ensure consistency among various federal and state cybersecurity regulations so that health care providers can focus on deploying their resources appropriately between securing patient information and the quality, safety, and accessibility of patient care” rather than having to focus on statutory and regulatory inconsistencies.
[email protected]
On Twitter @eaztweets
When computer hackers took control of the United Kingdom’s National Health Service using a virus known as “WannaCry,” doctors and nurses were left helpless, blocked from the files they would need to treat their patients until they paid to get them those files back.
Doctors were forced to revert to older methods, slowing everything to a snail’s pace.
The media coverage of the event was dramatic, but there is no doubt the effects made it justifiably so.
NHS hospitals had not achieved their goal of being paperless; had they been, the service would have been completely unable to stop the attack.
It was not just software that was affected but medical devices as well. Physicians were unable to perform x-rays, and some hospitals found that the refrigerators used to store blood products were shut down.
While the NHS was particularly vulnerable to the WannaCry because of budget cuts, this cybercrime could have happened to any hospital, and its lessons are applicable far all.
Doctors do understand the value of patients records, but they seem to be unaware of the physical harm that could befall patients from a cyberattack.
This attack needs to serve as a wake-up call for health care professionals who are not invested in their facilities’ cybersecurity practices.
Underfunding left NHS hospitals terribly exposed and, if physicians continue to be complacent with how to handle this issue, the results are sure to be more severe.
Rachel Clarke, MD, is at Oxford (England) University Hospitals NHS Foundation Trust, and Taryn Youngstein, MD, is at Imperial College Healthcare NHS Trust, London. They reported having no relevant financial conflicts of interest. Their remarks were make in a perspective published in the New England Journal of Medicine (doi: 10.1056/NEJMp1706754).
When computer hackers took control of the United Kingdom’s National Health Service using a virus known as “WannaCry,” doctors and nurses were left helpless, blocked from the files they would need to treat their patients until they paid to get them those files back.
Doctors were forced to revert to older methods, slowing everything to a snail’s pace.
The media coverage of the event was dramatic, but there is no doubt the effects made it justifiably so.
NHS hospitals had not achieved their goal of being paperless; had they been, the service would have been completely unable to stop the attack.
It was not just software that was affected but medical devices as well. Physicians were unable to perform x-rays, and some hospitals found that the refrigerators used to store blood products were shut down.
While the NHS was particularly vulnerable to the WannaCry because of budget cuts, this cybercrime could have happened to any hospital, and its lessons are applicable far all.
Doctors do understand the value of patients records, but they seem to be unaware of the physical harm that could befall patients from a cyberattack.
This attack needs to serve as a wake-up call for health care professionals who are not invested in their facilities’ cybersecurity practices.
Underfunding left NHS hospitals terribly exposed and, if physicians continue to be complacent with how to handle this issue, the results are sure to be more severe.
Rachel Clarke, MD, is at Oxford (England) University Hospitals NHS Foundation Trust, and Taryn Youngstein, MD, is at Imperial College Healthcare NHS Trust, London. They reported having no relevant financial conflicts of interest. Their remarks were make in a perspective published in the New England Journal of Medicine (doi: 10.1056/NEJMp1706754).
When computer hackers took control of the United Kingdom’s National Health Service using a virus known as “WannaCry,” doctors and nurses were left helpless, blocked from the files they would need to treat their patients until they paid to get them those files back.
Doctors were forced to revert to older methods, slowing everything to a snail’s pace.
The media coverage of the event was dramatic, but there is no doubt the effects made it justifiably so.
NHS hospitals had not achieved their goal of being paperless; had they been, the service would have been completely unable to stop the attack.
It was not just software that was affected but medical devices as well. Physicians were unable to perform x-rays, and some hospitals found that the refrigerators used to store blood products were shut down.
While the NHS was particularly vulnerable to the WannaCry because of budget cuts, this cybercrime could have happened to any hospital, and its lessons are applicable far all.
Doctors do understand the value of patients records, but they seem to be unaware of the physical harm that could befall patients from a cyberattack.
This attack needs to serve as a wake-up call for health care professionals who are not invested in their facilities’ cybersecurity practices.
Underfunding left NHS hospitals terribly exposed and, if physicians continue to be complacent with how to handle this issue, the results are sure to be more severe.
Rachel Clarke, MD, is at Oxford (England) University Hospitals NHS Foundation Trust, and Taryn Youngstein, MD, is at Imperial College Healthcare NHS Trust, London. They reported having no relevant financial conflicts of interest. Their remarks were make in a perspective published in the New England Journal of Medicine (doi: 10.1056/NEJMp1706754).
Aging equipment, valuable data, and an improperly trained workforce make health care IT extraordinarily vulnerable to external malfeasance, as demonstrated by the WannaCry virus episode that occurred this spring in the United Kingdom.
Computer hackers used a weakness in the operating system employed by the U.K. National Health Service, allowing the WannaCry virus to spread quickly across connected systems. The ransomware attack locked clinicians out of patient records and diagnostic machines that were connected, bringing patient care to a near standstill.
The attack lasted 3 days until Marcus Hutchins, a 22-year-old security researcher, stumbled onto a way to slow the spread of the virus enough to manage it, but not before nearly 60 million attacks had been conducted, Salim Neino, CEO of Kryptos Logic, testified June 15 at a joint hearing of two subcommittees of the House Science, Space & Technology Committee. Mr. Hutchins is employed by Kryptos Logic.
U.S. officials are keenly aware that a similar attack could happen here. In June, the federally sponsored Health Care Industry Cybersecurity Task Force issued a report on their year-long look at the state of the health care IT in this country. The task force was mandated by the Cybersecurity Act of 2015and formed in March 2016.
Specifically, the task force recommended:
• Defining and streamlining leadership, governance, and expectations for health care industry cybersecurity.
• Increasing the security and resilience of medical devices and health IT.
• Developing the health care workforce capacity necessary to prioritize and ensure cybersecurity awareness and technical capabilities.
• Increasing health care industry readiness through improved cybersecurity awareness and education.
• Identifying mechanisms to protect research and development efforts and intellectual property from attacks or exposure.
• Improving information sharing of industry threats, weaknesses, and mitigations.
Health care cybercrime is a significant problem in the United States. In 2016, 328 U.S. health care firms reported data breaches, up from 268 in 2015, with a total of 16.6 million Americans affected, according to a report conducted by Bitglass (registration required), a security software company. In February 2016, a hospital in California was forced to pay about $17,000 in Bitcoin, an electronic currency that is known to be favored by cybercriminals, to access electronic health records (EHRs) that were held in a similar manner to last month’s attack on the NHS.
For physicians, this may seem like someone else’s problem; however, unsafe day-to-day interactions with connected devices and patient EHRs were among the task force’s primary concerns.
For many, creating a safe password or not giving out critical information may seem like common sense, but many physicians are not able or willing to take the time to make sure they are interacting with systems safely, or they are overconfident in their security system, according to task force member Mark Jarrett, MD, senior vice president and chief quality officer at Northwell Health in New York.
“Most physicians now will try to access medical records of their patients who have been in the hospital because that’s good care,” Dr. Jarrett said in an interview. But they have to recognize that “they cannot give these passwords to other people and they need to make these passwords complex.”
“Phishing” is another concern. In a phishing scam, cybercriminals will pose as a fraudulent institution or individual in order to trick a target into downloading a virus, sending additional valuable information, or even paying money directly to the criminals.
“Physicians checking their emails need to be aware of possible phishing episodes, because they could be infected, and then there is the possibility that infection could be introduced into the system, Dr. Jarrett said. “I think the disconnect is [that physicians] are not used to [cybersecurity]. It’s not part of their daily life and they also, up until recently, thought ‘it’s never going to happen to me.’ ”
While hospitals are not completely incapable of protecting themselves, experts are concerned about an overinflated sense of confidence among health care professionals.
“Health care workers often assume that the IT network and the devices they support function efficiently and that their level of cybersecurity vulnerability is low,” according to the task force report.
This can be a costly assumption, financially, as well for safety; the price per stolen EHR averaged at $380 in 2016-2017, according to the Ponemon Institute’s 2017 Cost of Data Breach Study, released in June. That is nearly triple the average cost of all breaches – $141– and higher than the price of $241 for information stolen from financial industries because, unlike a credit card number, patients’ data are unique and cannot be replaced.
Aging equipment is another concern. Legacy software and machine systems used in medical practices and hospitals are not equipped with the necessary security services needed to handle the growing risks of connectivity, despite being included in the network.
“Every CT machine, every x-ray machine today is connected online, on one consolidated Internet” cybersecurity expert Idan Udi Edry of Trustifi said in an interview. “The more comfortable we are with the digital edge coming into our lives, the more vulnerable we become and the more security we need to implement to protect ourselves.”
Some solutions already have been suggested to help health care professionals replace their outdated equipment, especially private practice physicians or smaller hospitals without much financial wiggle room,
The cybersecurity task force report recommended creating health IT version of Cash for Clunkers, an Obama administration program that offered rebates to consumers who traded in older, less fuel efficient cars when purchasing a new car.
While experts agree that the growing focus on connected health care will continue to create cybersecurity risks, with all members of the health care industry working together, it is possible to keep hospitals and patients safe from would-be criminals.
The next key step is creating regulations that would encourage a cohesive structure of cybersecurity guidelines. According to the task force report, “a priority for regulatory agencies should be to ensure consistency among various federal and state cybersecurity regulations so that health care providers can focus on deploying their resources appropriately between securing patient information and the quality, safety, and accessibility of patient care” rather than having to focus on statutory and regulatory inconsistencies.
[email protected]
On Twitter @eaztweets
Aging equipment, valuable data, and an improperly trained workforce make health care IT extraordinarily vulnerable to external malfeasance, as demonstrated by the WannaCry virus episode that occurred this spring in the United Kingdom.
Computer hackers used a weakness in the operating system employed by the U.K. National Health Service, allowing the WannaCry virus to spread quickly across connected systems. The ransomware attack locked clinicians out of patient records and diagnostic machines that were connected, bringing patient care to a near standstill.
The attack lasted 3 days until Marcus Hutchins, a 22-year-old security researcher, stumbled onto a way to slow the spread of the virus enough to manage it, but not before nearly 60 million attacks had been conducted, Salim Neino, CEO of Kryptos Logic, testified June 15 at a joint hearing of two subcommittees of the House Science, Space & Technology Committee. Mr. Hutchins is employed by Kryptos Logic.
U.S. officials are keenly aware that a similar attack could happen here. In June, the federally sponsored Health Care Industry Cybersecurity Task Force issued a report on their year-long look at the state of the health care IT in this country. The task force was mandated by the Cybersecurity Act of 2015and formed in March 2016.
Specifically, the task force recommended:
• Defining and streamlining leadership, governance, and expectations for health care industry cybersecurity.
• Increasing the security and resilience of medical devices and health IT.
• Developing the health care workforce capacity necessary to prioritize and ensure cybersecurity awareness and technical capabilities.
• Increasing health care industry readiness through improved cybersecurity awareness and education.
• Identifying mechanisms to protect research and development efforts and intellectual property from attacks or exposure.
• Improving information sharing of industry threats, weaknesses, and mitigations.
Health care cybercrime is a significant problem in the United States. In 2016, 328 U.S. health care firms reported data breaches, up from 268 in 2015, with a total of 16.6 million Americans affected, according to a report conducted by Bitglass (registration required), a security software company. In February 2016, a hospital in California was forced to pay about $17,000 in Bitcoin, an electronic currency that is known to be favored by cybercriminals, to access electronic health records (EHRs) that were held in a similar manner to last month’s attack on the NHS.
For physicians, this may seem like someone else’s problem; however, unsafe day-to-day interactions with connected devices and patient EHRs were among the task force’s primary concerns.
For many, creating a safe password or not giving out critical information may seem like common sense, but many physicians are not able or willing to take the time to make sure they are interacting with systems safely, or they are overconfident in their security system, according to task force member Mark Jarrett, MD, senior vice president and chief quality officer at Northwell Health in New York.
“Most physicians now will try to access medical records of their patients who have been in the hospital because that’s good care,” Dr. Jarrett said in an interview. But they have to recognize that “they cannot give these passwords to other people and they need to make these passwords complex.”
“Phishing” is another concern. In a phishing scam, cybercriminals will pose as a fraudulent institution or individual in order to trick a target into downloading a virus, sending additional valuable information, or even paying money directly to the criminals.
“Physicians checking their emails need to be aware of possible phishing episodes, because they could be infected, and then there is the possibility that infection could be introduced into the system, Dr. Jarrett said. “I think the disconnect is [that physicians] are not used to [cybersecurity]. It’s not part of their daily life and they also, up until recently, thought ‘it’s never going to happen to me.’ ”
While hospitals are not completely incapable of protecting themselves, experts are concerned about an overinflated sense of confidence among health care professionals.
“Health care workers often assume that the IT network and the devices they support function efficiently and that their level of cybersecurity vulnerability is low,” according to the task force report.
This can be a costly assumption, financially, as well for safety; the price per stolen EHR averaged at $380 in 2016-2017, according to the Ponemon Institute’s 2017 Cost of Data Breach Study, released in June. That is nearly triple the average cost of all breaches – $141– and higher than the price of $241 for information stolen from financial industries because, unlike a credit card number, patients’ data are unique and cannot be replaced.
Aging equipment is another concern. Legacy software and machine systems used in medical practices and hospitals are not equipped with the necessary security services needed to handle the growing risks of connectivity, despite being included in the network.
“Every CT machine, every x-ray machine today is connected online, on one consolidated Internet” cybersecurity expert Idan Udi Edry of Trustifi said in an interview. “The more comfortable we are with the digital edge coming into our lives, the more vulnerable we become and the more security we need to implement to protect ourselves.”
Some solutions already have been suggested to help health care professionals replace their outdated equipment, especially private practice physicians or smaller hospitals without much financial wiggle room,
The cybersecurity task force report recommended creating health IT version of Cash for Clunkers, an Obama administration program that offered rebates to consumers who traded in older, less fuel efficient cars when purchasing a new car.
While experts agree that the growing focus on connected health care will continue to create cybersecurity risks, with all members of the health care industry working together, it is possible to keep hospitals and patients safe from would-be criminals.
The next key step is creating regulations that would encourage a cohesive structure of cybersecurity guidelines. According to the task force report, “a priority for regulatory agencies should be to ensure consistency among various federal and state cybersecurity regulations so that health care providers can focus on deploying their resources appropriately between securing patient information and the quality, safety, and accessibility of patient care” rather than having to focus on statutory and regulatory inconsistencies.
[email protected]
On Twitter @eaztweets