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ACIP recommends third MMR dose, if outbreak risk
The Advisory Committee on Immunization Practices voted Oct. 25 to recommend a 3rd dose of measles, mumps, and rubella (MMR) vaccine for individuals at mumps risk from an outbreak.
The recommendation applies to individuals who already have been vaccinated with the usual two doses of MMR “who are identified by public health as at increased risk for mumps because of an outbreak,” according to draft text of the recommendation. This practice would “improve protection against mumps disease and related complications.”
Young adults are at highest risk, she said.
Key evidence supporting the ACIP’s recommendation includes one recent study suggesting a 3rd dose of MMR is effective for mumps outbreak control (N Engl J Med. 2017 Sep 7; doi: 10.1056/NEJMoa1703309).
In that study, Cristina V. Cardemil, MD, of the CDC, and her colleagues looked at college students who received a 3rd MMR dose during an outbreak of at the University of Iowa in Iowa City. Almost a quarter of students (4,783 of 20,496) enrolled in the 2015-2016 academic year received a 3rd dose. Compared with two doses of MMR, students receiving three total doses had a 78% lower risk of mumps at 28 days after vaccination, investigators reported.
“These findings suggest that the campaign to administer a 3rd dose of MMR vaccine improved mumps outbreak control and that waning immunity probably contributed to propagation of the outbreak,” Dr. Cardemil and her colleagues wrote.
The vote in favor of a 3rd dose was unanimous among 15 voting members of ACIP. The committee’s recommendations must be approved by the CDC director before they are considered official recommendations.
The Advisory Committee on Immunization Practices voted Oct. 25 to recommend a 3rd dose of measles, mumps, and rubella (MMR) vaccine for individuals at mumps risk from an outbreak.
The recommendation applies to individuals who already have been vaccinated with the usual two doses of MMR “who are identified by public health as at increased risk for mumps because of an outbreak,” according to draft text of the recommendation. This practice would “improve protection against mumps disease and related complications.”
Young adults are at highest risk, she said.
Key evidence supporting the ACIP’s recommendation includes one recent study suggesting a 3rd dose of MMR is effective for mumps outbreak control (N Engl J Med. 2017 Sep 7; doi: 10.1056/NEJMoa1703309).
In that study, Cristina V. Cardemil, MD, of the CDC, and her colleagues looked at college students who received a 3rd MMR dose during an outbreak of at the University of Iowa in Iowa City. Almost a quarter of students (4,783 of 20,496) enrolled in the 2015-2016 academic year received a 3rd dose. Compared with two doses of MMR, students receiving three total doses had a 78% lower risk of mumps at 28 days after vaccination, investigators reported.
“These findings suggest that the campaign to administer a 3rd dose of MMR vaccine improved mumps outbreak control and that waning immunity probably contributed to propagation of the outbreak,” Dr. Cardemil and her colleagues wrote.
The vote in favor of a 3rd dose was unanimous among 15 voting members of ACIP. The committee’s recommendations must be approved by the CDC director before they are considered official recommendations.
The Advisory Committee on Immunization Practices voted Oct. 25 to recommend a 3rd dose of measles, mumps, and rubella (MMR) vaccine for individuals at mumps risk from an outbreak.
The recommendation applies to individuals who already have been vaccinated with the usual two doses of MMR “who are identified by public health as at increased risk for mumps because of an outbreak,” according to draft text of the recommendation. This practice would “improve protection against mumps disease and related complications.”
Young adults are at highest risk, she said.
Key evidence supporting the ACIP’s recommendation includes one recent study suggesting a 3rd dose of MMR is effective for mumps outbreak control (N Engl J Med. 2017 Sep 7; doi: 10.1056/NEJMoa1703309).
In that study, Cristina V. Cardemil, MD, of the CDC, and her colleagues looked at college students who received a 3rd MMR dose during an outbreak of at the University of Iowa in Iowa City. Almost a quarter of students (4,783 of 20,496) enrolled in the 2015-2016 academic year received a 3rd dose. Compared with two doses of MMR, students receiving three total doses had a 78% lower risk of mumps at 28 days after vaccination, investigators reported.
“These findings suggest that the campaign to administer a 3rd dose of MMR vaccine improved mumps outbreak control and that waning immunity probably contributed to propagation of the outbreak,” Dr. Cardemil and her colleagues wrote.
The vote in favor of a 3rd dose was unanimous among 15 voting members of ACIP. The committee’s recommendations must be approved by the CDC director before they are considered official recommendations.
AT AN ACIP MEETING
VIDEO: Burnout affects half of U.S. gastroenterologists
ORLANDO – Nearly half of U.S. gastroenterologists who responded to a recent survey had symptoms of burnout that seemed largely driven by work-life balance issues.
Burnout appeared to disproportionately affect younger gastroenterologists, those who spend more time on chores at home including caring for young children, physicians who were neutral toward or dissatisfied with a spouse or partner, and clinicians planning to soon leave their practice, Carol A. Burke, MD, said at the World Congress of Gastroenterology at ACG 2017.
Factors not linked with burnout included their type of practice, whether the gastroenterologists worked full or part time, their location, and their compensation, said Dr. Burke, director of the Center for Colon Polyp and Cancer Prevention at the Cleveland Clinic.
The life issues that appeared most strongly linked to burnout “speak to a problem for physicians to balance” their professional and personal lives, Dr. Burke said in a video interview. Several interventions exist that can potentially mitigate burnout, and the American College of Gastroenterology, which ran the survey, is taking steps to make information on these interventions available to members, noted Dr. Burke, the organization’s president.
Dr. Burke and her associates sent a 60-item survey to all 11,080 College members during 2014 and 2015 and received 1,021 replies including 754 fully completed responses. Their prespecified definition of burnout was a high score for emotional exhaustion or for depersonalization, or both, on the Maslach Burnout Inventory. The results showed that 45% of respondents had a high score for emotional exhaustion, 21% scored high on depersonalization, and overall 49% met the burnout criteria set by the investigators. The Inventory answers also showed that 18% had a low sense of personal accomplishment.
A multivariate analysis showed that significant links with burnout were younger age, more time spent on domestic chores, having a neutral or dissatisfying relationship with a spouse or partner, and plans for imminent retirement from gastroenterology practice, Dr. Burke reported.
The main reasons for planning imminent retirement were reimbursement, cited by 32% of this subgroup, regulations, cited by 21%, recertification, cited by 16%, and electronic medical records, cited by 10% as the main reason for leaving practice.
Strategies and resources aimed at better dealing with burnout were requested by 60% of all survey respondents, and the College is in the process of making these tools available, Dr. Burke said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
ORLANDO – Nearly half of U.S. gastroenterologists who responded to a recent survey had symptoms of burnout that seemed largely driven by work-life balance issues.
Burnout appeared to disproportionately affect younger gastroenterologists, those who spend more time on chores at home including caring for young children, physicians who were neutral toward or dissatisfied with a spouse or partner, and clinicians planning to soon leave their practice, Carol A. Burke, MD, said at the World Congress of Gastroenterology at ACG 2017.
Factors not linked with burnout included their type of practice, whether the gastroenterologists worked full or part time, their location, and their compensation, said Dr. Burke, director of the Center for Colon Polyp and Cancer Prevention at the Cleveland Clinic.
The life issues that appeared most strongly linked to burnout “speak to a problem for physicians to balance” their professional and personal lives, Dr. Burke said in a video interview. Several interventions exist that can potentially mitigate burnout, and the American College of Gastroenterology, which ran the survey, is taking steps to make information on these interventions available to members, noted Dr. Burke, the organization’s president.
Dr. Burke and her associates sent a 60-item survey to all 11,080 College members during 2014 and 2015 and received 1,021 replies including 754 fully completed responses. Their prespecified definition of burnout was a high score for emotional exhaustion or for depersonalization, or both, on the Maslach Burnout Inventory. The results showed that 45% of respondents had a high score for emotional exhaustion, 21% scored high on depersonalization, and overall 49% met the burnout criteria set by the investigators. The Inventory answers also showed that 18% had a low sense of personal accomplishment.
A multivariate analysis showed that significant links with burnout were younger age, more time spent on domestic chores, having a neutral or dissatisfying relationship with a spouse or partner, and plans for imminent retirement from gastroenterology practice, Dr. Burke reported.
The main reasons for planning imminent retirement were reimbursement, cited by 32% of this subgroup, regulations, cited by 21%, recertification, cited by 16%, and electronic medical records, cited by 10% as the main reason for leaving practice.
Strategies and resources aimed at better dealing with burnout were requested by 60% of all survey respondents, and the College is in the process of making these tools available, Dr. Burke said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
ORLANDO – Nearly half of U.S. gastroenterologists who responded to a recent survey had symptoms of burnout that seemed largely driven by work-life balance issues.
Burnout appeared to disproportionately affect younger gastroenterologists, those who spend more time on chores at home including caring for young children, physicians who were neutral toward or dissatisfied with a spouse or partner, and clinicians planning to soon leave their practice, Carol A. Burke, MD, said at the World Congress of Gastroenterology at ACG 2017.
Factors not linked with burnout included their type of practice, whether the gastroenterologists worked full or part time, their location, and their compensation, said Dr. Burke, director of the Center for Colon Polyp and Cancer Prevention at the Cleveland Clinic.
The life issues that appeared most strongly linked to burnout “speak to a problem for physicians to balance” their professional and personal lives, Dr. Burke said in a video interview. Several interventions exist that can potentially mitigate burnout, and the American College of Gastroenterology, which ran the survey, is taking steps to make information on these interventions available to members, noted Dr. Burke, the organization’s president.
Dr. Burke and her associates sent a 60-item survey to all 11,080 College members during 2014 and 2015 and received 1,021 replies including 754 fully completed responses. Their prespecified definition of burnout was a high score for emotional exhaustion or for depersonalization, or both, on the Maslach Burnout Inventory. The results showed that 45% of respondents had a high score for emotional exhaustion, 21% scored high on depersonalization, and overall 49% met the burnout criteria set by the investigators. The Inventory answers also showed that 18% had a low sense of personal accomplishment.
A multivariate analysis showed that significant links with burnout were younger age, more time spent on domestic chores, having a neutral or dissatisfying relationship with a spouse or partner, and plans for imminent retirement from gastroenterology practice, Dr. Burke reported.
The main reasons for planning imminent retirement were reimbursement, cited by 32% of this subgroup, regulations, cited by 21%, recertification, cited by 16%, and electronic medical records, cited by 10% as the main reason for leaving practice.
Strategies and resources aimed at better dealing with burnout were requested by 60% of all survey respondents, and the College is in the process of making these tools available, Dr. Burke said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT THE 13TH WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Forty-nine percent of surveyed U.S. gastroenterologists showed a high level of emotional exhaustion, depersonalization, or both.
Data source: Survey results from 754 members of the American College of Gastroenterology.
Disclosures: The American College of Gastroenterology funded the survey. Dr. Burke had no relevant disclosures.
Citrate reactions seen in 7% of apheresis donations
SAN DIEGO – , based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.
Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.
The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.
Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.
Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.
During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.
Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).
“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.
The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).
The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.
SAN DIEGO – , based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.
Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.
The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.
Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.
Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.
During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.
Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).
“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.
The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).
The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.
SAN DIEGO – , based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.
Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.
The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.
Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.
Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.
During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.
Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).
“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.
The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).
The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.
AT AABB17
Key clinical point: Adverse reactions to apheresis donations can be significant; calcium supplements can reduce the risk of citrate reactions and volume replacement can reduce the risk of vasovagal reactions in donors.
Major finding: Citrate reactions accompanied 6.8% of donations; 2.5% had vasovagal reactions without loss of consciousness and 0.1% had loss of consciousness.
Data source: A study at Héma-Québec, Montreal, of 80,409 apheresis procedures conducted in 14,742 donors.
Disclosures: Dr. Robillard had no disclosures.
State regulations for tattoo facilities increased blood donor pools
SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.
“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.
Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.
Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.
In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.
They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.
For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).
A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.
“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.
SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.
“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.
Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.
Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.
In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.
They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.
For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).
A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.
“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.
SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.
“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.
Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.
Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.
In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.
They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.
For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).
A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.
“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.
AT AABB 2017
Key clinical point:
Major finding: The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
Data source: An analysis of blood centers in California and Arizona before and after state tattoo regulations were implemented.
Disclosures: Dr. Townsend has no disclosures.
Stroke cognitive outcomes found worse in Mexican Americans
SAN DIEGO – A new analysis shows that Mexican Americans (MAs) have worse cognitive outcomes a year after having a stroke than do non-Hispanic whites (NHWs).
The findings, which show that MAs had a mean score of 86 on the Modified Mini-Mental State Examination (3MSE; range: 0-100), compared with 92 for NHWs, come from a prospective study of MAs and NHWs in Corpus Christi, Texas, where both populations have long-established residencies.
After controlling for all factors, the researchers found a difference of –6.73 (95% confidence interval, –3.88 to –9.57; P less than .001).
“The Mexican-American population is growing quickly and aging. The cost of stroke-related cognitive impairment is high for patient, family, and society. Efforts to combat stroke-related cognitive decline are critical,” said Dr. Morgenstern, professor of neurology and epidemiology at the University of Michigan, Ann Arbor.
The study grew out of the Brain Attack Surveillance in Corpus Christi (BASIC) Project, which began in 1999 and is funded until 2019. It is the only ongoing stroke surveillance program that focuses on Mexican Americans, who comprise the largest segment of Hispanic Americans.
The researchers analyzed data encompassing all stroke patients in the BASIC Project from October 2014 through January 2016 (n = 227). They analyzed cognitive outcome data from 3 months, 6 months, and 12 months. MAs were younger on average than NHWs (median age 66 vs. 70; P = .018), and were more likely to have diabetes (54% vs. 36%; P less than .001). They were less likely to have atrial fibrillation (13% vs. 20%; P = .025).
At 12 months, MAs had a lower median 3MSE score of 86 (interquartile range, 73-93, compared with 92 in NHWs (IQR, 83-96; P less than .001). As the researchers adjusted for additional factors, the discrepancy became larger. Adjustment for age and sex revealed a difference of 6.88 (95% confidence interval, 4.15-9.60). Additional adjustment for prestroke condition showed a difference of 7.04. Additional adjustment for insurance led to the same differential of 7.04. Adjustment for diabetes and comorbidities pushed the difference to 7.11. Adjustment for stroke severity (National Institutes of Health Stroke Scale) revealed a difference of 6.73 (P less than .001).
Asked if the results were surprising, Dr. Morgenstern replied: “I think it’s always surprising to see one population of U.S. citizens who have more disease or a worse outcome than another when it’s not explained by the many possible factors we considered.” He also called for additional studies of cognitive dysfunction in Hispanic communities in other forms of dementia, such as Alzheimer’s disease and vascular dementia. “There’s very little of that,” he said.
The National Institutes of Health funded the study. Dr. Morgenstern reported having no financial disclosures.
SAN DIEGO – A new analysis shows that Mexican Americans (MAs) have worse cognitive outcomes a year after having a stroke than do non-Hispanic whites (NHWs).
The findings, which show that MAs had a mean score of 86 on the Modified Mini-Mental State Examination (3MSE; range: 0-100), compared with 92 for NHWs, come from a prospective study of MAs and NHWs in Corpus Christi, Texas, where both populations have long-established residencies.
After controlling for all factors, the researchers found a difference of –6.73 (95% confidence interval, –3.88 to –9.57; P less than .001).
“The Mexican-American population is growing quickly and aging. The cost of stroke-related cognitive impairment is high for patient, family, and society. Efforts to combat stroke-related cognitive decline are critical,” said Dr. Morgenstern, professor of neurology and epidemiology at the University of Michigan, Ann Arbor.
The study grew out of the Brain Attack Surveillance in Corpus Christi (BASIC) Project, which began in 1999 and is funded until 2019. It is the only ongoing stroke surveillance program that focuses on Mexican Americans, who comprise the largest segment of Hispanic Americans.
The researchers analyzed data encompassing all stroke patients in the BASIC Project from October 2014 through January 2016 (n = 227). They analyzed cognitive outcome data from 3 months, 6 months, and 12 months. MAs were younger on average than NHWs (median age 66 vs. 70; P = .018), and were more likely to have diabetes (54% vs. 36%; P less than .001). They were less likely to have atrial fibrillation (13% vs. 20%; P = .025).
At 12 months, MAs had a lower median 3MSE score of 86 (interquartile range, 73-93, compared with 92 in NHWs (IQR, 83-96; P less than .001). As the researchers adjusted for additional factors, the discrepancy became larger. Adjustment for age and sex revealed a difference of 6.88 (95% confidence interval, 4.15-9.60). Additional adjustment for prestroke condition showed a difference of 7.04. Additional adjustment for insurance led to the same differential of 7.04. Adjustment for diabetes and comorbidities pushed the difference to 7.11. Adjustment for stroke severity (National Institutes of Health Stroke Scale) revealed a difference of 6.73 (P less than .001).
Asked if the results were surprising, Dr. Morgenstern replied: “I think it’s always surprising to see one population of U.S. citizens who have more disease or a worse outcome than another when it’s not explained by the many possible factors we considered.” He also called for additional studies of cognitive dysfunction in Hispanic communities in other forms of dementia, such as Alzheimer’s disease and vascular dementia. “There’s very little of that,” he said.
The National Institutes of Health funded the study. Dr. Morgenstern reported having no financial disclosures.
SAN DIEGO – A new analysis shows that Mexican Americans (MAs) have worse cognitive outcomes a year after having a stroke than do non-Hispanic whites (NHWs).
The findings, which show that MAs had a mean score of 86 on the Modified Mini-Mental State Examination (3MSE; range: 0-100), compared with 92 for NHWs, come from a prospective study of MAs and NHWs in Corpus Christi, Texas, where both populations have long-established residencies.
After controlling for all factors, the researchers found a difference of –6.73 (95% confidence interval, –3.88 to –9.57; P less than .001).
“The Mexican-American population is growing quickly and aging. The cost of stroke-related cognitive impairment is high for patient, family, and society. Efforts to combat stroke-related cognitive decline are critical,” said Dr. Morgenstern, professor of neurology and epidemiology at the University of Michigan, Ann Arbor.
The study grew out of the Brain Attack Surveillance in Corpus Christi (BASIC) Project, which began in 1999 and is funded until 2019. It is the only ongoing stroke surveillance program that focuses on Mexican Americans, who comprise the largest segment of Hispanic Americans.
The researchers analyzed data encompassing all stroke patients in the BASIC Project from October 2014 through January 2016 (n = 227). They analyzed cognitive outcome data from 3 months, 6 months, and 12 months. MAs were younger on average than NHWs (median age 66 vs. 70; P = .018), and were more likely to have diabetes (54% vs. 36%; P less than .001). They were less likely to have atrial fibrillation (13% vs. 20%; P = .025).
At 12 months, MAs had a lower median 3MSE score of 86 (interquartile range, 73-93, compared with 92 in NHWs (IQR, 83-96; P less than .001). As the researchers adjusted for additional factors, the discrepancy became larger. Adjustment for age and sex revealed a difference of 6.88 (95% confidence interval, 4.15-9.60). Additional adjustment for prestroke condition showed a difference of 7.04. Additional adjustment for insurance led to the same differential of 7.04. Adjustment for diabetes and comorbidities pushed the difference to 7.11. Adjustment for stroke severity (National Institutes of Health Stroke Scale) revealed a difference of 6.73 (P less than .001).
Asked if the results were surprising, Dr. Morgenstern replied: “I think it’s always surprising to see one population of U.S. citizens who have more disease or a worse outcome than another when it’s not explained by the many possible factors we considered.” He also called for additional studies of cognitive dysfunction in Hispanic communities in other forms of dementia, such as Alzheimer’s disease and vascular dementia. “There’s very little of that,” he said.
The National Institutes of Health funded the study. Dr. Morgenstern reported having no financial disclosures.
AT ANA 2017
Key clinical point: In an analysis, cognitive outcomes were worse in Mexican-American stroke survivors despite researchers’ controlling for many factors.
Major finding: At 12 months, Mexican Americans scored 6 points lower on the Modified Mini-Mental State Examination compared with non-Hispanic whites.
Data source: Prospective analysis of 227 stroke patients in Corpus Christi, Texas.
Disclosures: The National Institutes of Health funded the study. Dr. Morgenstern reported having no financial disclosures.
Patients prefer higher dose of levothyroxine despite lack of objective benefit
VICTORIA, B.C. – Patient perception plays a large role in subjective benefit of levothyroxine therapy for hypothyroidism, suggests a double-blind randomized controlled trial reported at the annual meeting of the American Thyroid Association.
Mood, cognition, and quality of life (QoL) did not differ whether patients’ levothyroxine dose was adjusted to achieve thyroid-stimulating hormone (TSH) levels in the low-normal, high-normal, or mildly elevated range. But despite this lack of objective benefit, the large majority of patients preferred levothyroxine doses that they perceived to be higher – whether they actually were or not.
The study was not restricted to certain groups who might have a better response to higher levothyroxine dose, she acknowledged. Two such groups are patients with more symptoms (although volunteering for the study suggested dissatisfaction with symptom control) and patients with low tri-iodothyronine (T3) levels (although about half of patients had low baseline levels).
“We encourage further research in older subjects, men, and subjects with specific symptoms, low T3 levels, or functional polymorphisms in thyroid-relevant genes,” Dr. Samuels said. “These are really difficult, expensive studies to do, and if we are going to have any hope of getting them funded and doing them, I think that we have to be much more targeted.”
One of the session co-chairs, Catherine A. Dinauer, MD, a pediatric endocrinologist and clinician at the Yale Pediatric Thyroid Center, New Haven, Conn., commented, “I think these are really interesting data because there’s this sense among patients that their dose really affects how they feel, and this is essentially turning that on its head. It’s not really clear, then, why are these patients still maybe not feeling well.”
“It will be interesting to see more data on this and ... more about this business of checking T3 levels. Do we need to supplement with T3? I think we really don’t know that, especially in kids, but even in adults,” she added.
The other session co-chair, Yaron Tomer, MD, chair of the department of medicine and the Anita and Jack Saltz Chair in Diabetes Research at the Montefiore Medical Center, Bronx, N.Y., commented, “I think this study confirmed what a lot of us feel, that there is a lot of placebo effect when you treat in different ways to optimize the TSH or give T3.”
Other data reported in the session provide a possible explanation for the lack of benefit of adjusting pharmacologic therapy, suggesting that the volumes of various brain structures change with perturbations of thyroid function, he noted. “There might be true changes in the brain that affect how the patients feel. So these patients may truly not feel well. It’s just that we can’t fix it by adjusting the TSH level to very narrow margins or by adding T3,” he said.
Study details
“It is well known that overt hypothyroidism interferes with mood and a number of cognitive functions. However, neurocognitive effects of variations in thyroid function within the reference range and in mild or subclinical hypothyroidism are less clear,” Dr. Samuels noted, giving some background to the research.
“Observational studies of this question have tended to be negative but have often included less sensitive global screening tests of cognition. There are very few small-scale interventional studies,” she continued. “In the absence of conclusive data, many patients with mild hypothyroidism are started on levothyroxine to treat nonspecific quality of life, mood, or cognitive symptoms, and many additional treated patients request increased levothyroxine doses due to persistence of these symptoms.”
Dr. Samuels and her coinvestigators enrolled in the trial 138 hypothyroid but otherwise healthy patients who had been on a stable dose of levothyroxine (Synthroid and others) alone for at least 3 months and had normal TSH levels.
The patients were randomized to three groups in which clinicians adjusted levothyroxine dose every 6 weeks in blinded fashion to achieve different target TSH levels: low-normal TSH (0.34-2.50 mU/L), high-normal TSH (2.51-5.60 mU/L), or mildly elevated TSH (5.60-12.0 mU/L). Patients completed a battery of assessments at baseline and again at 6 months.
Main results confirmed that TSH targets were generally achieved, with significantly different mean TSH levels in the low-normal group (1.34 mU/L), high-normal group (3.74 mU/L), and mildly elevated group (9.74 mU/L) (P less than .05).
In crude analyses, results differed significantly across groups for only two of the dozens of measures of mood, cognition, and QoL assessed: bodily pain (26%, 11%, and 34% of patients reporting a high pain level in the low-normal, high-normal, and mildly elevated TSH groups, respectively; P = .03) and working memory on the N-Back test (86%, 58%, and 75% with a 1-back result; P = .002). However, there were no significant differences for any of the measures when analyses were repeated with statistical correction for multiple comparisons.
At the end of the study, patients were unable to say with any accuracy say whether they were receiving a dose of levothyroxine that was higher than, lower than, or unchanged from their baseline dose (P = .55 for actual vs. perceived).
However, patients preferred what they perceived to be a higher dose (P less than .001 for preferred vs. perceived). In the group perceiving their end-of-study dose was higher, the majority of patients (68%) preferred that dose, and in the group perceiving their end-of-study dose was lower, most (96%) preferred their baseline dose.
The sample size may not have been adequate to detect very small effects of changes in levothyroxine dose, acknowledged Dr. Samuels, who disclosed that she had no relevant conflicts of interest. Additionally, patients were predominantly female and younger, and heterogeneous with respect to thyroid diagnosis and length of levothyroxine therapy.
VICTORIA, B.C. – Patient perception plays a large role in subjective benefit of levothyroxine therapy for hypothyroidism, suggests a double-blind randomized controlled trial reported at the annual meeting of the American Thyroid Association.
Mood, cognition, and quality of life (QoL) did not differ whether patients’ levothyroxine dose was adjusted to achieve thyroid-stimulating hormone (TSH) levels in the low-normal, high-normal, or mildly elevated range. But despite this lack of objective benefit, the large majority of patients preferred levothyroxine doses that they perceived to be higher – whether they actually were or not.
The study was not restricted to certain groups who might have a better response to higher levothyroxine dose, she acknowledged. Two such groups are patients with more symptoms (although volunteering for the study suggested dissatisfaction with symptom control) and patients with low tri-iodothyronine (T3) levels (although about half of patients had low baseline levels).
“We encourage further research in older subjects, men, and subjects with specific symptoms, low T3 levels, or functional polymorphisms in thyroid-relevant genes,” Dr. Samuels said. “These are really difficult, expensive studies to do, and if we are going to have any hope of getting them funded and doing them, I think that we have to be much more targeted.”
One of the session co-chairs, Catherine A. Dinauer, MD, a pediatric endocrinologist and clinician at the Yale Pediatric Thyroid Center, New Haven, Conn., commented, “I think these are really interesting data because there’s this sense among patients that their dose really affects how they feel, and this is essentially turning that on its head. It’s not really clear, then, why are these patients still maybe not feeling well.”
“It will be interesting to see more data on this and ... more about this business of checking T3 levels. Do we need to supplement with T3? I think we really don’t know that, especially in kids, but even in adults,” she added.
The other session co-chair, Yaron Tomer, MD, chair of the department of medicine and the Anita and Jack Saltz Chair in Diabetes Research at the Montefiore Medical Center, Bronx, N.Y., commented, “I think this study confirmed what a lot of us feel, that there is a lot of placebo effect when you treat in different ways to optimize the TSH or give T3.”
Other data reported in the session provide a possible explanation for the lack of benefit of adjusting pharmacologic therapy, suggesting that the volumes of various brain structures change with perturbations of thyroid function, he noted. “There might be true changes in the brain that affect how the patients feel. So these patients may truly not feel well. It’s just that we can’t fix it by adjusting the TSH level to very narrow margins or by adding T3,” he said.
Study details
“It is well known that overt hypothyroidism interferes with mood and a number of cognitive functions. However, neurocognitive effects of variations in thyroid function within the reference range and in mild or subclinical hypothyroidism are less clear,” Dr. Samuels noted, giving some background to the research.
“Observational studies of this question have tended to be negative but have often included less sensitive global screening tests of cognition. There are very few small-scale interventional studies,” she continued. “In the absence of conclusive data, many patients with mild hypothyroidism are started on levothyroxine to treat nonspecific quality of life, mood, or cognitive symptoms, and many additional treated patients request increased levothyroxine doses due to persistence of these symptoms.”
Dr. Samuels and her coinvestigators enrolled in the trial 138 hypothyroid but otherwise healthy patients who had been on a stable dose of levothyroxine (Synthroid and others) alone for at least 3 months and had normal TSH levels.
The patients were randomized to three groups in which clinicians adjusted levothyroxine dose every 6 weeks in blinded fashion to achieve different target TSH levels: low-normal TSH (0.34-2.50 mU/L), high-normal TSH (2.51-5.60 mU/L), or mildly elevated TSH (5.60-12.0 mU/L). Patients completed a battery of assessments at baseline and again at 6 months.
Main results confirmed that TSH targets were generally achieved, with significantly different mean TSH levels in the low-normal group (1.34 mU/L), high-normal group (3.74 mU/L), and mildly elevated group (9.74 mU/L) (P less than .05).
In crude analyses, results differed significantly across groups for only two of the dozens of measures of mood, cognition, and QoL assessed: bodily pain (26%, 11%, and 34% of patients reporting a high pain level in the low-normal, high-normal, and mildly elevated TSH groups, respectively; P = .03) and working memory on the N-Back test (86%, 58%, and 75% with a 1-back result; P = .002). However, there were no significant differences for any of the measures when analyses were repeated with statistical correction for multiple comparisons.
At the end of the study, patients were unable to say with any accuracy say whether they were receiving a dose of levothyroxine that was higher than, lower than, or unchanged from their baseline dose (P = .55 for actual vs. perceived).
However, patients preferred what they perceived to be a higher dose (P less than .001 for preferred vs. perceived). In the group perceiving their end-of-study dose was higher, the majority of patients (68%) preferred that dose, and in the group perceiving their end-of-study dose was lower, most (96%) preferred their baseline dose.
The sample size may not have been adequate to detect very small effects of changes in levothyroxine dose, acknowledged Dr. Samuels, who disclosed that she had no relevant conflicts of interest. Additionally, patients were predominantly female and younger, and heterogeneous with respect to thyroid diagnosis and length of levothyroxine therapy.
VICTORIA, B.C. – Patient perception plays a large role in subjective benefit of levothyroxine therapy for hypothyroidism, suggests a double-blind randomized controlled trial reported at the annual meeting of the American Thyroid Association.
Mood, cognition, and quality of life (QoL) did not differ whether patients’ levothyroxine dose was adjusted to achieve thyroid-stimulating hormone (TSH) levels in the low-normal, high-normal, or mildly elevated range. But despite this lack of objective benefit, the large majority of patients preferred levothyroxine doses that they perceived to be higher – whether they actually were or not.
The study was not restricted to certain groups who might have a better response to higher levothyroxine dose, she acknowledged. Two such groups are patients with more symptoms (although volunteering for the study suggested dissatisfaction with symptom control) and patients with low tri-iodothyronine (T3) levels (although about half of patients had low baseline levels).
“We encourage further research in older subjects, men, and subjects with specific symptoms, low T3 levels, or functional polymorphisms in thyroid-relevant genes,” Dr. Samuels said. “These are really difficult, expensive studies to do, and if we are going to have any hope of getting them funded and doing them, I think that we have to be much more targeted.”
One of the session co-chairs, Catherine A. Dinauer, MD, a pediatric endocrinologist and clinician at the Yale Pediatric Thyroid Center, New Haven, Conn., commented, “I think these are really interesting data because there’s this sense among patients that their dose really affects how they feel, and this is essentially turning that on its head. It’s not really clear, then, why are these patients still maybe not feeling well.”
“It will be interesting to see more data on this and ... more about this business of checking T3 levels. Do we need to supplement with T3? I think we really don’t know that, especially in kids, but even in adults,” she added.
The other session co-chair, Yaron Tomer, MD, chair of the department of medicine and the Anita and Jack Saltz Chair in Diabetes Research at the Montefiore Medical Center, Bronx, N.Y., commented, “I think this study confirmed what a lot of us feel, that there is a lot of placebo effect when you treat in different ways to optimize the TSH or give T3.”
Other data reported in the session provide a possible explanation for the lack of benefit of adjusting pharmacologic therapy, suggesting that the volumes of various brain structures change with perturbations of thyroid function, he noted. “There might be true changes in the brain that affect how the patients feel. So these patients may truly not feel well. It’s just that we can’t fix it by adjusting the TSH level to very narrow margins or by adding T3,” he said.
Study details
“It is well known that overt hypothyroidism interferes with mood and a number of cognitive functions. However, neurocognitive effects of variations in thyroid function within the reference range and in mild or subclinical hypothyroidism are less clear,” Dr. Samuels noted, giving some background to the research.
“Observational studies of this question have tended to be negative but have often included less sensitive global screening tests of cognition. There are very few small-scale interventional studies,” she continued. “In the absence of conclusive data, many patients with mild hypothyroidism are started on levothyroxine to treat nonspecific quality of life, mood, or cognitive symptoms, and many additional treated patients request increased levothyroxine doses due to persistence of these symptoms.”
Dr. Samuels and her coinvestigators enrolled in the trial 138 hypothyroid but otherwise healthy patients who had been on a stable dose of levothyroxine (Synthroid and others) alone for at least 3 months and had normal TSH levels.
The patients were randomized to three groups in which clinicians adjusted levothyroxine dose every 6 weeks in blinded fashion to achieve different target TSH levels: low-normal TSH (0.34-2.50 mU/L), high-normal TSH (2.51-5.60 mU/L), or mildly elevated TSH (5.60-12.0 mU/L). Patients completed a battery of assessments at baseline and again at 6 months.
Main results confirmed that TSH targets were generally achieved, with significantly different mean TSH levels in the low-normal group (1.34 mU/L), high-normal group (3.74 mU/L), and mildly elevated group (9.74 mU/L) (P less than .05).
In crude analyses, results differed significantly across groups for only two of the dozens of measures of mood, cognition, and QoL assessed: bodily pain (26%, 11%, and 34% of patients reporting a high pain level in the low-normal, high-normal, and mildly elevated TSH groups, respectively; P = .03) and working memory on the N-Back test (86%, 58%, and 75% with a 1-back result; P = .002). However, there were no significant differences for any of the measures when analyses were repeated with statistical correction for multiple comparisons.
At the end of the study, patients were unable to say with any accuracy say whether they were receiving a dose of levothyroxine that was higher than, lower than, or unchanged from their baseline dose (P = .55 for actual vs. perceived).
However, patients preferred what they perceived to be a higher dose (P less than .001 for preferred vs. perceived). In the group perceiving their end-of-study dose was higher, the majority of patients (68%) preferred that dose, and in the group perceiving their end-of-study dose was lower, most (96%) preferred their baseline dose.
The sample size may not have been adequate to detect very small effects of changes in levothyroxine dose, acknowledged Dr. Samuels, who disclosed that she had no relevant conflicts of interest. Additionally, patients were predominantly female and younger, and heterogeneous with respect to thyroid diagnosis and length of levothyroxine therapy.
AT ATA 2017
Key clinical point:
Major finding: Mood, cognition, and QoL were similar across levothyroxine doses targeting various TSH levels, but patients preferred what they believed was a higher dose, even when it was not (P less than .001 for preferred vs. perceived).
Data source: A randomized trial of levothyroxine adjustment among 138 hypothyroid patients on a stable dose of the drug who had normal TSH levels.
Disclosures: Dr. Samuels disclosed that she had no relevant conflicts of interest.
Conjugate typhoid vaccine safe and effective in phase 2 trials
A new conjugate typhoid vaccine suitable for administration to infants and young children was efficacious, highly immunogenic, and well tolerated, compared with placebo, in a phase 2 study that tested the vaccine using a human typhoid infection model.
In a study that compared two formulations of typhoid vaccine to a control meningococcal vaccine, the new Vi-conjugate (Vi-TT) vaccine had an efficacy of 54.6% (95% confidence interval, 26.8-71.8) and a 100% seroconversion rate.
The study was not powered for a direct comparison of the efficacy of the Vi-TT with the efficacy of the Vi-polysaccharide (Vi-PS), the other vaccine used in the study. The Vi-PS vaccine had an efficacy of 52.0% (95% CI, 23.2-70.0), and 88.6% of the Vi-PS recipients had seroconversion.
However, “clinical manifestations of typhoid fever seemed less severe among diagnosed participants following Vi-TT vaccination,” Celina Jin, MD, and her colleagues wrote (Lancet. 2017 Sep 28: doi: 10.1016/S0140-6736[17]32149-9). Fever, defined as an oral temperature of 38° C or higher, was seen in 6 of 37 (16%) Vi-TT recipients, 17 of 31 (55%) receiving control, and 11 of 35 (31%) receiving Vi-PS.
Geometric mean titers also were significantly higher in the Vi-TT group than in the Vi-PS group, with an adjusted geometric mean titer of 562.9 EU/mL for Vi-TT and 140.5 EU/mL for Vi-PS (P less than .0001).
The study enrolled 112 healthy adult volunteers who were randomized 1:1:1 to receive Vi-PS, Vi-TT, or control meningococcal vaccine. A total of 103 of the participants eventually received one of the two study vaccines or the control vaccines, and that group was included in the per-protocol analysis.
After vaccination (recipients and investigators were masked as to which formulation participants received), study participants kept an online diary to report any vaccination-related symptoms for 7 days, and also had clinic visits scheduled at days 1, 3, 7, and 10.
Participants received one oral dose of wild-type Salmonella enterica serovar Typhi Quailes strain bacteria about 1 month after vaccination. The dose was 1-5x104 colony forming units, and was administered immediately following a 120-mL oral bolus of sodium bicarbonate (to neutralize stomach acid).
Participants then were seen daily in an outpatient clinic for 2 weeks. At each visit, investigators monitored vital signs, performed a general assessment, and drew blood to assess for typhoid bacteremia. Participants also kept an online diary for 21 days, reporting twice-daily self-measured temperatures as well. No antipyretics were allowed before typhoid diagnosis.
Participants who met the study’s criteria for typhoid diagnosis were treated with a 2-week course of ciprofloxacin or azithromycin; patients who did not become ill were treated 14 days after the oral typhoid challenge. None of the four serious adverse events reported during the study was deemed to be related to vaccination.
That broad definition of typhoid infection was used to determine attack rates for the study’s primary outcome measure. However, Dr. Jin and her colleagues also looked at a less stringent – and perhaps more clinically pertinent – definition of 12 hours of fever of 38° C or higher followed by S. Typhi bacteremia. Using those criteria, the Vi-TT vaccine prevented up to 87% of infections.
Salmonella Typhi is the world’s leading cause of enteric fever, said Dr. Jin, of the Oxford Vaccine Group at the University of Oxford (England). Up to 20.6 million people per year are affected, with children most commonly infected and low-resource populations in Asia and Africa hardest hit.
Both prescription and over-the-counter antibiotics are used worldwide to combat typhoid fever, and S. Typhi strains are becoming increasingly antibiotic resistant in South Asia and Africa, Dr. Jin and her coauthors said.
The typhoid vaccines that are currently licensed are either not suitable for administration to infants and young children, or are insufficiently immunogenic in younger populations.
The typhoid conjugate vaccine used in the study combines the Vi-polysaccharide capsule with a protein carrier, increasing host immunologic response and making the vaccine effective in infancy.
“This human challenge study provides further evidence to support the deployment of Vi-conjugate vaccines as a control measure to reduce the burden of typhoid fever, because those individuals living in endemic regions should not be made to wait another 60 years,” wrote Dr. Jin and her coauthors.
The study was funded by the Bill & Melinda Gates Foundation and the European commission FP7 grant, Advanced Immunization Technologies.
The Oxford Vaccine Group has developed a typhoid challenge model that provides an important bridge in clinical testing and affords the possibility of significant acceleration of the vaccine development process. Despite the controversy human challenge models sometimes engender, previous human typhoid challenge studies contributed to the development of the live attenuated typhoid vaccine Ty21a.
The conjugate vaccine tested by Dr. Jin and her colleagues is a much-needed weapon in the public health armamentarium of typhoid control. Treatment options are limited in regions of South Asia and Africa where endemic typhoid shows increasing antibiotic resistance.
This human challenge study provides the first evidence that the conjugate vaccine reduces the attack rate of typhoid fever, though its use in India has shown it to be safe and immunogenic, even in children as young as 6 months of age.
The stringent definition of typhoid fever attack used in this study may result in a finding of lower efficacy than would be seen in a field trial, and a National Institutes of Health–sponsored study of another conjugate vaccine found efficacy rates of 89% among Vietnamese preschoolers followed for nearly 4 years after vaccination. When the present study’s data were reanalyzed with use of the less stringent case definition of fever followed by typhoid bacteremia, a similar efficacy of 87.1% was seen for the conjugate vaccine. A larger sample size would be needed in a challenge study that included the less stringent definition as a coprimary endpoint, but results might better correlate with real-world field trials.
Phase 3 and 4 trials for the typhoid conjugate vaccine are forthcoming, but final results will not be tallied for many years. The typhoid challenge study reported by Dr. Jin and her colleagues bolsters hopes that the candidate vaccine will help with typhoid control where it’s most needed.
Nicholas A. Feasey, MD , is at the Liverpool (England) School of Tropical Medicine. Myron M. Levine, MD , is at the University of Maryland, Baltimore. Their comments were drawn from an editorial accompanying the study (Lancet. 2017 Sep 28. doi: 10.1016/S0140-6736[17]32407-8 ).
The Oxford Vaccine Group has developed a typhoid challenge model that provides an important bridge in clinical testing and affords the possibility of significant acceleration of the vaccine development process. Despite the controversy human challenge models sometimes engender, previous human typhoid challenge studies contributed to the development of the live attenuated typhoid vaccine Ty21a.
The conjugate vaccine tested by Dr. Jin and her colleagues is a much-needed weapon in the public health armamentarium of typhoid control. Treatment options are limited in regions of South Asia and Africa where endemic typhoid shows increasing antibiotic resistance.
This human challenge study provides the first evidence that the conjugate vaccine reduces the attack rate of typhoid fever, though its use in India has shown it to be safe and immunogenic, even in children as young as 6 months of age.
The stringent definition of typhoid fever attack used in this study may result in a finding of lower efficacy than would be seen in a field trial, and a National Institutes of Health–sponsored study of another conjugate vaccine found efficacy rates of 89% among Vietnamese preschoolers followed for nearly 4 years after vaccination. When the present study’s data were reanalyzed with use of the less stringent case definition of fever followed by typhoid bacteremia, a similar efficacy of 87.1% was seen for the conjugate vaccine. A larger sample size would be needed in a challenge study that included the less stringent definition as a coprimary endpoint, but results might better correlate with real-world field trials.
Phase 3 and 4 trials for the typhoid conjugate vaccine are forthcoming, but final results will not be tallied for many years. The typhoid challenge study reported by Dr. Jin and her colleagues bolsters hopes that the candidate vaccine will help with typhoid control where it’s most needed.
Nicholas A. Feasey, MD , is at the Liverpool (England) School of Tropical Medicine. Myron M. Levine, MD , is at the University of Maryland, Baltimore. Their comments were drawn from an editorial accompanying the study (Lancet. 2017 Sep 28. doi: 10.1016/S0140-6736[17]32407-8 ).
The Oxford Vaccine Group has developed a typhoid challenge model that provides an important bridge in clinical testing and affords the possibility of significant acceleration of the vaccine development process. Despite the controversy human challenge models sometimes engender, previous human typhoid challenge studies contributed to the development of the live attenuated typhoid vaccine Ty21a.
The conjugate vaccine tested by Dr. Jin and her colleagues is a much-needed weapon in the public health armamentarium of typhoid control. Treatment options are limited in regions of South Asia and Africa where endemic typhoid shows increasing antibiotic resistance.
This human challenge study provides the first evidence that the conjugate vaccine reduces the attack rate of typhoid fever, though its use in India has shown it to be safe and immunogenic, even in children as young as 6 months of age.
The stringent definition of typhoid fever attack used in this study may result in a finding of lower efficacy than would be seen in a field trial, and a National Institutes of Health–sponsored study of another conjugate vaccine found efficacy rates of 89% among Vietnamese preschoolers followed for nearly 4 years after vaccination. When the present study’s data were reanalyzed with use of the less stringent case definition of fever followed by typhoid bacteremia, a similar efficacy of 87.1% was seen for the conjugate vaccine. A larger sample size would be needed in a challenge study that included the less stringent definition as a coprimary endpoint, but results might better correlate with real-world field trials.
Phase 3 and 4 trials for the typhoid conjugate vaccine are forthcoming, but final results will not be tallied for many years. The typhoid challenge study reported by Dr. Jin and her colleagues bolsters hopes that the candidate vaccine will help with typhoid control where it’s most needed.
Nicholas A. Feasey, MD , is at the Liverpool (England) School of Tropical Medicine. Myron M. Levine, MD , is at the University of Maryland, Baltimore. Their comments were drawn from an editorial accompanying the study (Lancet. 2017 Sep 28. doi: 10.1016/S0140-6736[17]32407-8 ).
A new conjugate typhoid vaccine suitable for administration to infants and young children was efficacious, highly immunogenic, and well tolerated, compared with placebo, in a phase 2 study that tested the vaccine using a human typhoid infection model.
In a study that compared two formulations of typhoid vaccine to a control meningococcal vaccine, the new Vi-conjugate (Vi-TT) vaccine had an efficacy of 54.6% (95% confidence interval, 26.8-71.8) and a 100% seroconversion rate.
The study was not powered for a direct comparison of the efficacy of the Vi-TT with the efficacy of the Vi-polysaccharide (Vi-PS), the other vaccine used in the study. The Vi-PS vaccine had an efficacy of 52.0% (95% CI, 23.2-70.0), and 88.6% of the Vi-PS recipients had seroconversion.
However, “clinical manifestations of typhoid fever seemed less severe among diagnosed participants following Vi-TT vaccination,” Celina Jin, MD, and her colleagues wrote (Lancet. 2017 Sep 28: doi: 10.1016/S0140-6736[17]32149-9). Fever, defined as an oral temperature of 38° C or higher, was seen in 6 of 37 (16%) Vi-TT recipients, 17 of 31 (55%) receiving control, and 11 of 35 (31%) receiving Vi-PS.
Geometric mean titers also were significantly higher in the Vi-TT group than in the Vi-PS group, with an adjusted geometric mean titer of 562.9 EU/mL for Vi-TT and 140.5 EU/mL for Vi-PS (P less than .0001).
The study enrolled 112 healthy adult volunteers who were randomized 1:1:1 to receive Vi-PS, Vi-TT, or control meningococcal vaccine. A total of 103 of the participants eventually received one of the two study vaccines or the control vaccines, and that group was included in the per-protocol analysis.
After vaccination (recipients and investigators were masked as to which formulation participants received), study participants kept an online diary to report any vaccination-related symptoms for 7 days, and also had clinic visits scheduled at days 1, 3, 7, and 10.
Participants received one oral dose of wild-type Salmonella enterica serovar Typhi Quailes strain bacteria about 1 month after vaccination. The dose was 1-5x104 colony forming units, and was administered immediately following a 120-mL oral bolus of sodium bicarbonate (to neutralize stomach acid).
Participants then were seen daily in an outpatient clinic for 2 weeks. At each visit, investigators monitored vital signs, performed a general assessment, and drew blood to assess for typhoid bacteremia. Participants also kept an online diary for 21 days, reporting twice-daily self-measured temperatures as well. No antipyretics were allowed before typhoid diagnosis.
Participants who met the study’s criteria for typhoid diagnosis were treated with a 2-week course of ciprofloxacin or azithromycin; patients who did not become ill were treated 14 days after the oral typhoid challenge. None of the four serious adverse events reported during the study was deemed to be related to vaccination.
That broad definition of typhoid infection was used to determine attack rates for the study’s primary outcome measure. However, Dr. Jin and her colleagues also looked at a less stringent – and perhaps more clinically pertinent – definition of 12 hours of fever of 38° C or higher followed by S. Typhi bacteremia. Using those criteria, the Vi-TT vaccine prevented up to 87% of infections.
Salmonella Typhi is the world’s leading cause of enteric fever, said Dr. Jin, of the Oxford Vaccine Group at the University of Oxford (England). Up to 20.6 million people per year are affected, with children most commonly infected and low-resource populations in Asia and Africa hardest hit.
Both prescription and over-the-counter antibiotics are used worldwide to combat typhoid fever, and S. Typhi strains are becoming increasingly antibiotic resistant in South Asia and Africa, Dr. Jin and her coauthors said.
The typhoid vaccines that are currently licensed are either not suitable for administration to infants and young children, or are insufficiently immunogenic in younger populations.
The typhoid conjugate vaccine used in the study combines the Vi-polysaccharide capsule with a protein carrier, increasing host immunologic response and making the vaccine effective in infancy.
“This human challenge study provides further evidence to support the deployment of Vi-conjugate vaccines as a control measure to reduce the burden of typhoid fever, because those individuals living in endemic regions should not be made to wait another 60 years,” wrote Dr. Jin and her coauthors.
The study was funded by the Bill & Melinda Gates Foundation and the European commission FP7 grant, Advanced Immunization Technologies.
A new conjugate typhoid vaccine suitable for administration to infants and young children was efficacious, highly immunogenic, and well tolerated, compared with placebo, in a phase 2 study that tested the vaccine using a human typhoid infection model.
In a study that compared two formulations of typhoid vaccine to a control meningococcal vaccine, the new Vi-conjugate (Vi-TT) vaccine had an efficacy of 54.6% (95% confidence interval, 26.8-71.8) and a 100% seroconversion rate.
The study was not powered for a direct comparison of the efficacy of the Vi-TT with the efficacy of the Vi-polysaccharide (Vi-PS), the other vaccine used in the study. The Vi-PS vaccine had an efficacy of 52.0% (95% CI, 23.2-70.0), and 88.6% of the Vi-PS recipients had seroconversion.
However, “clinical manifestations of typhoid fever seemed less severe among diagnosed participants following Vi-TT vaccination,” Celina Jin, MD, and her colleagues wrote (Lancet. 2017 Sep 28: doi: 10.1016/S0140-6736[17]32149-9). Fever, defined as an oral temperature of 38° C or higher, was seen in 6 of 37 (16%) Vi-TT recipients, 17 of 31 (55%) receiving control, and 11 of 35 (31%) receiving Vi-PS.
Geometric mean titers also were significantly higher in the Vi-TT group than in the Vi-PS group, with an adjusted geometric mean titer of 562.9 EU/mL for Vi-TT and 140.5 EU/mL for Vi-PS (P less than .0001).
The study enrolled 112 healthy adult volunteers who were randomized 1:1:1 to receive Vi-PS, Vi-TT, or control meningococcal vaccine. A total of 103 of the participants eventually received one of the two study vaccines or the control vaccines, and that group was included in the per-protocol analysis.
After vaccination (recipients and investigators were masked as to which formulation participants received), study participants kept an online diary to report any vaccination-related symptoms for 7 days, and also had clinic visits scheduled at days 1, 3, 7, and 10.
Participants received one oral dose of wild-type Salmonella enterica serovar Typhi Quailes strain bacteria about 1 month after vaccination. The dose was 1-5x104 colony forming units, and was administered immediately following a 120-mL oral bolus of sodium bicarbonate (to neutralize stomach acid).
Participants then were seen daily in an outpatient clinic for 2 weeks. At each visit, investigators monitored vital signs, performed a general assessment, and drew blood to assess for typhoid bacteremia. Participants also kept an online diary for 21 days, reporting twice-daily self-measured temperatures as well. No antipyretics were allowed before typhoid diagnosis.
Participants who met the study’s criteria for typhoid diagnosis were treated with a 2-week course of ciprofloxacin or azithromycin; patients who did not become ill were treated 14 days after the oral typhoid challenge. None of the four serious adverse events reported during the study was deemed to be related to vaccination.
That broad definition of typhoid infection was used to determine attack rates for the study’s primary outcome measure. However, Dr. Jin and her colleagues also looked at a less stringent – and perhaps more clinically pertinent – definition of 12 hours of fever of 38° C or higher followed by S. Typhi bacteremia. Using those criteria, the Vi-TT vaccine prevented up to 87% of infections.
Salmonella Typhi is the world’s leading cause of enteric fever, said Dr. Jin, of the Oxford Vaccine Group at the University of Oxford (England). Up to 20.6 million people per year are affected, with children most commonly infected and low-resource populations in Asia and Africa hardest hit.
Both prescription and over-the-counter antibiotics are used worldwide to combat typhoid fever, and S. Typhi strains are becoming increasingly antibiotic resistant in South Asia and Africa, Dr. Jin and her coauthors said.
The typhoid vaccines that are currently licensed are either not suitable for administration to infants and young children, or are insufficiently immunogenic in younger populations.
The typhoid conjugate vaccine used in the study combines the Vi-polysaccharide capsule with a protein carrier, increasing host immunologic response and making the vaccine effective in infancy.
“This human challenge study provides further evidence to support the deployment of Vi-conjugate vaccines as a control measure to reduce the burden of typhoid fever, because those individuals living in endemic regions should not be made to wait another 60 years,” wrote Dr. Jin and her coauthors.
The study was funded by the Bill & Melinda Gates Foundation and the European commission FP7 grant, Advanced Immunization Technologies.
FROM THE LANCET
Key clinical point: A conjugate typhoid vaccine significantly reduced typhoid fever rates under a stringent case definition.
Major finding: Efficacy was 54.6% for the Vi-conjugate vaccine, with 100% seroconversion.
Study details: Randomized, controlled phase 2b trial of 112 participants receiving one of two typhoid vaccines, or control meningococcal vaccine.
Disclosures: The study was funded by the Bill & Melinda Gates Foundation and the European Commission FP7 grant, Advanced Immunization Technologies.
CHEST Physician’s planned coverage of CHEST 2017
CHEST Physician is providing on-site coverage of the CHEST annual meeting in Toronto from Oct. 29 through Nov. 1.
We are planning to share findings from the latest research on treating COPD, sleep apnea, pulmonary hypertension, severe asthma, and other diseases that are part of pulmonary, critical care, and sleep medicine. Any improved methods for managing an ICU and updated recommendations on screening for lung cancer will also be on our radar.
The meeting’s agenda includes presentations of hundreds of study abstracts, and we thought you would be interested in hearing which ones grabbed the attention of some of CHEST Physician’s editorial advisory board members.
Board member Susan L. Millard, MD, FCCP, suggested attendees check out presentations of the following two studies:
- Impact of Race on Quality of Life of Families of Children with Asthma when Asthma Guidelines are Followed: Long-Term Follow-Up
- Results Of A Phase 3, Multicenter, Randomized, Placebo-controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine for Bronchoscopy
The first study is part of a session entitled Pediatrics, scheduled to run from 3:15 to 4:15 p.m. on Sunday, Oct. 29, in Convention Center - 606. Shahid Sheikh, MD, of Nationwide Children’s Hospital in New Albany, Ohio, is scheduled to present the abstract at 4:00 p.m.
Dr. Millard, who is Therapeutic Development Network director for the Pediatric CF Care Center and director of research for pediatric pulmonary and sleep medicine at the Helen DeVos Children’s Hospital in Grand Rapids, Mich., noted that she is interested in Dr. Sheikh’s research, “because cultural diversity is such a hot topic in general.”
Her other recommendation is part of the Late Breaking Abstracts 2 session, scheduled to occur on Wednesday, Nov. 1, from 2:45 to 4:15 p.m. in Convention Center - 603. CHEST President, Gerard A. Silvestri, MD, MS, FCCP, will present the abstract at 4:00 p.m.
Dr. Millard said she is interested in this study, because new drug options are so helpful for the frequently performed bronchoscopy.
Two sleep medicine experts on CHEST Physician’s editorial advisory board also selected a few presentations they expect to be newsworthy.
David Schulman, MD, MPH, FCCP, and professor of medicine at Emory University School of Medicine in Atlanta suggested CHEST Physician cover the following studies:
- Results of a Randomized, Placebo-Controlled, Double-Blind, 12-Week, Multicenter Study of JZP-110 for the Treatment Of Excessive Sleepiness in Patients with OSA, scheduled to be presented on Sunday, Oct. 29, at 1:30 p.m. in Convention Center - 601A. Dr. Kingman Strohl, MD, FCCP, of University Hospitals Case Medical Center-Sleep Center in Shaker Heights, Ohio, will present this research during a session entitled, Obstructive Sleep Apnea: Insights & Management, running from 1:30 to 3:00 p.m.
- History of Sleep Apnea and Cardiovascular Disease may Portend Improved Mortality in Patients With Acute Ischemic Stroke, scheduled to be presented on Tuesday, Oct. 31, at 11:15 a.m., in Convention Center - 601A. Nura Festic will present this research during the session, “Sleep, Heart, Brain and More,” running from 11:00 a.m. to 12:15 p.m.
- Ischemic Preconditioning in OSA Patients Manifested after Surviving a Cardiac Arrest? John Moss, MD, of Jacksonville, Fla., will present this study on Tuesday, Oct. 31, at 11:30 a.m., in Convention Center - 601A as part of the session “Sleep, Heart, Brain and More.”
Krishna M. Sundar, MD, FCCP, also recommended that CHEST Physician cover “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients.” Lirim Krveshi is scheduled to present this study on Sunday, Oct. 29, at 1:45 p.m. in Convention Center - 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session.
Dr. Sundar is an associate clinical professor of pulmonary, critical care and sleep medicine and medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City.
To view the full agenda of the CHEST annual meeting, visit: chestmeeting.chestnet.org.
Look for CHEST Physician’s coverage of CHEST 2017 on our conference coverage page.
CHEST Physician is providing on-site coverage of the CHEST annual meeting in Toronto from Oct. 29 through Nov. 1.
We are planning to share findings from the latest research on treating COPD, sleep apnea, pulmonary hypertension, severe asthma, and other diseases that are part of pulmonary, critical care, and sleep medicine. Any improved methods for managing an ICU and updated recommendations on screening for lung cancer will also be on our radar.
The meeting’s agenda includes presentations of hundreds of study abstracts, and we thought you would be interested in hearing which ones grabbed the attention of some of CHEST Physician’s editorial advisory board members.
Board member Susan L. Millard, MD, FCCP, suggested attendees check out presentations of the following two studies:
- Impact of Race on Quality of Life of Families of Children with Asthma when Asthma Guidelines are Followed: Long-Term Follow-Up
- Results Of A Phase 3, Multicenter, Randomized, Placebo-controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine for Bronchoscopy
The first study is part of a session entitled Pediatrics, scheduled to run from 3:15 to 4:15 p.m. on Sunday, Oct. 29, in Convention Center - 606. Shahid Sheikh, MD, of Nationwide Children’s Hospital in New Albany, Ohio, is scheduled to present the abstract at 4:00 p.m.
Dr. Millard, who is Therapeutic Development Network director for the Pediatric CF Care Center and director of research for pediatric pulmonary and sleep medicine at the Helen DeVos Children’s Hospital in Grand Rapids, Mich., noted that she is interested in Dr. Sheikh’s research, “because cultural diversity is such a hot topic in general.”
Her other recommendation is part of the Late Breaking Abstracts 2 session, scheduled to occur on Wednesday, Nov. 1, from 2:45 to 4:15 p.m. in Convention Center - 603. CHEST President, Gerard A. Silvestri, MD, MS, FCCP, will present the abstract at 4:00 p.m.
Dr. Millard said she is interested in this study, because new drug options are so helpful for the frequently performed bronchoscopy.
Two sleep medicine experts on CHEST Physician’s editorial advisory board also selected a few presentations they expect to be newsworthy.
David Schulman, MD, MPH, FCCP, and professor of medicine at Emory University School of Medicine in Atlanta suggested CHEST Physician cover the following studies:
- Results of a Randomized, Placebo-Controlled, Double-Blind, 12-Week, Multicenter Study of JZP-110 for the Treatment Of Excessive Sleepiness in Patients with OSA, scheduled to be presented on Sunday, Oct. 29, at 1:30 p.m. in Convention Center - 601A. Dr. Kingman Strohl, MD, FCCP, of University Hospitals Case Medical Center-Sleep Center in Shaker Heights, Ohio, will present this research during a session entitled, Obstructive Sleep Apnea: Insights & Management, running from 1:30 to 3:00 p.m.
- History of Sleep Apnea and Cardiovascular Disease may Portend Improved Mortality in Patients With Acute Ischemic Stroke, scheduled to be presented on Tuesday, Oct. 31, at 11:15 a.m., in Convention Center - 601A. Nura Festic will present this research during the session, “Sleep, Heart, Brain and More,” running from 11:00 a.m. to 12:15 p.m.
- Ischemic Preconditioning in OSA Patients Manifested after Surviving a Cardiac Arrest? John Moss, MD, of Jacksonville, Fla., will present this study on Tuesday, Oct. 31, at 11:30 a.m., in Convention Center - 601A as part of the session “Sleep, Heart, Brain and More.”
Krishna M. Sundar, MD, FCCP, also recommended that CHEST Physician cover “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients.” Lirim Krveshi is scheduled to present this study on Sunday, Oct. 29, at 1:45 p.m. in Convention Center - 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session.
Dr. Sundar is an associate clinical professor of pulmonary, critical care and sleep medicine and medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City.
To view the full agenda of the CHEST annual meeting, visit: chestmeeting.chestnet.org.
Look for CHEST Physician’s coverage of CHEST 2017 on our conference coverage page.
CHEST Physician is providing on-site coverage of the CHEST annual meeting in Toronto from Oct. 29 through Nov. 1.
We are planning to share findings from the latest research on treating COPD, sleep apnea, pulmonary hypertension, severe asthma, and other diseases that are part of pulmonary, critical care, and sleep medicine. Any improved methods for managing an ICU and updated recommendations on screening for lung cancer will also be on our radar.
The meeting’s agenda includes presentations of hundreds of study abstracts, and we thought you would be interested in hearing which ones grabbed the attention of some of CHEST Physician’s editorial advisory board members.
Board member Susan L. Millard, MD, FCCP, suggested attendees check out presentations of the following two studies:
- Impact of Race on Quality of Life of Families of Children with Asthma when Asthma Guidelines are Followed: Long-Term Follow-Up
- Results Of A Phase 3, Multicenter, Randomized, Placebo-controlled Trial of Remimazolam: A New Ultra Short Acting Benzodiazepine for Bronchoscopy
The first study is part of a session entitled Pediatrics, scheduled to run from 3:15 to 4:15 p.m. on Sunday, Oct. 29, in Convention Center - 606. Shahid Sheikh, MD, of Nationwide Children’s Hospital in New Albany, Ohio, is scheduled to present the abstract at 4:00 p.m.
Dr. Millard, who is Therapeutic Development Network director for the Pediatric CF Care Center and director of research for pediatric pulmonary and sleep medicine at the Helen DeVos Children’s Hospital in Grand Rapids, Mich., noted that she is interested in Dr. Sheikh’s research, “because cultural diversity is such a hot topic in general.”
Her other recommendation is part of the Late Breaking Abstracts 2 session, scheduled to occur on Wednesday, Nov. 1, from 2:45 to 4:15 p.m. in Convention Center - 603. CHEST President, Gerard A. Silvestri, MD, MS, FCCP, will present the abstract at 4:00 p.m.
Dr. Millard said she is interested in this study, because new drug options are so helpful for the frequently performed bronchoscopy.
Two sleep medicine experts on CHEST Physician’s editorial advisory board also selected a few presentations they expect to be newsworthy.
David Schulman, MD, MPH, FCCP, and professor of medicine at Emory University School of Medicine in Atlanta suggested CHEST Physician cover the following studies:
- Results of a Randomized, Placebo-Controlled, Double-Blind, 12-Week, Multicenter Study of JZP-110 for the Treatment Of Excessive Sleepiness in Patients with OSA, scheduled to be presented on Sunday, Oct. 29, at 1:30 p.m. in Convention Center - 601A. Dr. Kingman Strohl, MD, FCCP, of University Hospitals Case Medical Center-Sleep Center in Shaker Heights, Ohio, will present this research during a session entitled, Obstructive Sleep Apnea: Insights & Management, running from 1:30 to 3:00 p.m.
- History of Sleep Apnea and Cardiovascular Disease may Portend Improved Mortality in Patients With Acute Ischemic Stroke, scheduled to be presented on Tuesday, Oct. 31, at 11:15 a.m., in Convention Center - 601A. Nura Festic will present this research during the session, “Sleep, Heart, Brain and More,” running from 11:00 a.m. to 12:15 p.m.
- Ischemic Preconditioning in OSA Patients Manifested after Surviving a Cardiac Arrest? John Moss, MD, of Jacksonville, Fla., will present this study on Tuesday, Oct. 31, at 11:30 a.m., in Convention Center - 601A as part of the session “Sleep, Heart, Brain and More.”
Krishna M. Sundar, MD, FCCP, also recommended that CHEST Physician cover “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients.” Lirim Krveshi is scheduled to present this study on Sunday, Oct. 29, at 1:45 p.m. in Convention Center - 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session.
Dr. Sundar is an associate clinical professor of pulmonary, critical care and sleep medicine and medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City.
To view the full agenda of the CHEST annual meeting, visit: chestmeeting.chestnet.org.
Look for CHEST Physician’s coverage of CHEST 2017 on our conference coverage page.
FROM CHEST 2017
Stopping anti-TNF drugs in PsA has high rebound risk
A report on the largest cohort to date of patients with psoriatic arthritis who discontinued tumor necrosis factor inhibitor (TNFi) therapy during a period of low disease activity adds further evidence in support of keeping patients on the biologics during such periods.
The findings from the report on patients with psoriatic arthritis (PsA) from the U.S. Corrona registry found a rebound in disease activity in 69 (73%) of 94 patients. These results are in line with prior small studies, including a pilot, randomized, controlled trial, in PsA patients who have attempted to stop conventional synthetic disease-modifying antirheumatic drugs and biologic DMARDs, mostly TNFi agents, during periods of low disease activity (LDA).
The 73% rate of disease activity rebound observed in the patients – defined by a Clinical Disease Activity Index (CDAI) score of more than 10, a reinitiation of their TNFi, or the start of a new agent – “offers an important perspective for physicians who are considering TNFi discontinuation for patients who have achieved remission/LDA and may provide a key piece of data in discussing the most likely potential outcome with their patients’ TNFi discontinuation,” Dr. Harrold and her associates wrote. “TNFi discontinuation after achieving LDA should be carefully considered.”
The 94 patients with PsA in the Corrona registry study all met study criteria for remission or LDA (CDAI score of 10 or less) and had discontinued their TNFi while in LDA and did not immediately switch to a different biologic. The mean age of the patients was 51; 57% were women and 92% were white. At the time of TNFi initiation, they had an average disease duration of 8.4 years and a mean CDAI score of 10.1, and 64% had LDA. Most patients had taken methotrexate (86%) or a conventional synthetic DMARD (10%) prior to starting a TNFi (J Rheumatol. 2017 Oct 1. doi: 10.3899/jrheum.161567).
Among the 69 patients with rebound of disease activity, 15 had a CDAI score of greater than 10, 24 restarted a biologic DMARD but did not have an elevated CDAI, and 30 had both an elevated CDAI and biologic initiation.
Close to three-quarters of the 59 rebounders who returned for a postrebound visit were in remission or LDA at that visit, and nearly half had resumed use of their original TNFi by the time of the visit.
The U.S.-based Corrona registry has registered about 6,000 PsA patients from around 500 rheumatologists since 2001. The conclusions that can be drawn from the current study, which included patients who started a TNFi between Oct. 1, 2002, and March 21, 2013, are limited by the use of the CDAI, a measure for disease activity in rheumatoid arthritis. The use of the CDAI means that disease features of PsA such as enthesitis, psoriasis, and dactylitis were not captured in the assessment of LDA. “That is a caveat,” Dr. Harrold said.
Other limitations of the study include its sporadic follow-up and the open-label, uncontrolled nature of the TNFi discontinuation, according to Dr. Helliwell.
“There could have been any number of reasons why the drug was stopped, not just because of low disease activity – because of financial reasons, perhaps, adverse events, or ... a switch to another drug,” he said in an interview.
Despite these limitations, Dr. Helliwell said that the study “provides useful data, and it will add to the number of publications on this subject that are already out there, and it is the biggest cohort that’s been published.”
Dr. Harrold and her coauthors said that their findings were consistent with those from other studies, including one that Dr. Helliwell’s group was a part of.
That was a pilot randomized, controlled trial to test the feasibility of drug withdrawal in PsA patients in a stable, low disease state, defined by meeting minimal disease activity criteria. Of the 17 patients randomized, 6 of 11 who were in the withdrawal arm experienced a flare (defined as not meeting minimal disease activity criteria). Of these six patients, two had been receiving methotrexate only and four had been treated with methotrexate plus a biologic, whereas none of the six patients who continued therapy experienced a flare (Clin Rheumatol. 2015;34[8]:1407-12). Dr. Helliwell noted that all patients in the withdrawal arm eventually relapsed.
Another study with similar results from investigators at the University of Erlangen-Nuremberg (Germany) found that out of 26 PsA patients on either methotrexate monotherapy (n = 14) or a TNFi (n = 12), with no musculoskeletal symptoms and minimal skin disease, 20 had disease recurrence at a mean of just 74 days after drug discontinuation (Ann Rheum Dis. 2015;74:655-60).
Investigators for another study from the Corrona registry looked at 325 discontinuations of TNFi therapy while in LDA in 302 PsA patients and found disease rebound in 45% at an estimated median time of about 29 months. This study included a physician’s global assessment of skin psoriasis of 20 or less out of 100 as part of the definition of LDA, in addition to a CDAI score of 10 or less. Current smoking was the only significant predictor of disease rebound in a multivariate analysis. Age, gender, the number of prior TNFis used, or overweight or obese status did not predict disease rebound. CDAI score of 3.2 or greater was just outside the range of statistical significance (RMD Open. 2017;3:e000395).
“I think the message here is: ‘Be very careful discontinuing anti-TNF drugs in people with PsA and low disease activity.’ It’s not the same as rheumatoid arthritis in that respect,” Dr. Helliwell said.
Ultimately, the goal is to determine the characteristics of patients who can either stop or taper drugs such as TNF inhibitors. “I think there are going to be patients who can be tapered off, and there are going to be patients who can’t be,” Dr. Harrold said. Going forward, it will be important to identify which subset of patients are going to flare when taken off medication, such as a TNF inhibitor, particularly because of the diversity of presentations that PsA patients can have, she said.
Dr. Helliwell agreed, saying that, when he is asked whether you can stop a TNFi in PsA patients with LDA, “I say you should taper the drug by increasing the interval between doses or lower the dose, but not discontinue it.”
The Corrona registry has been supported by numerous pharmaceutical companies that manufacture drugs for PsA and rheumatoid arthritis. Dr. Harrold and some of her coinvestigators are employees and shareholders of Corrona. Some authors are employees and shareholders of Amgen, and others reported financial relationships with various pharmaceutical companies. Dr. Helliwell has received grant or research support, consulted for, or served on the speakers bureau for many of the companies that support Corrona.
A report on the largest cohort to date of patients with psoriatic arthritis who discontinued tumor necrosis factor inhibitor (TNFi) therapy during a period of low disease activity adds further evidence in support of keeping patients on the biologics during such periods.
The findings from the report on patients with psoriatic arthritis (PsA) from the U.S. Corrona registry found a rebound in disease activity in 69 (73%) of 94 patients. These results are in line with prior small studies, including a pilot, randomized, controlled trial, in PsA patients who have attempted to stop conventional synthetic disease-modifying antirheumatic drugs and biologic DMARDs, mostly TNFi agents, during periods of low disease activity (LDA).
The 73% rate of disease activity rebound observed in the patients – defined by a Clinical Disease Activity Index (CDAI) score of more than 10, a reinitiation of their TNFi, or the start of a new agent – “offers an important perspective for physicians who are considering TNFi discontinuation for patients who have achieved remission/LDA and may provide a key piece of data in discussing the most likely potential outcome with their patients’ TNFi discontinuation,” Dr. Harrold and her associates wrote. “TNFi discontinuation after achieving LDA should be carefully considered.”
The 94 patients with PsA in the Corrona registry study all met study criteria for remission or LDA (CDAI score of 10 or less) and had discontinued their TNFi while in LDA and did not immediately switch to a different biologic. The mean age of the patients was 51; 57% were women and 92% were white. At the time of TNFi initiation, they had an average disease duration of 8.4 years and a mean CDAI score of 10.1, and 64% had LDA. Most patients had taken methotrexate (86%) or a conventional synthetic DMARD (10%) prior to starting a TNFi (J Rheumatol. 2017 Oct 1. doi: 10.3899/jrheum.161567).
Among the 69 patients with rebound of disease activity, 15 had a CDAI score of greater than 10, 24 restarted a biologic DMARD but did not have an elevated CDAI, and 30 had both an elevated CDAI and biologic initiation.
Close to three-quarters of the 59 rebounders who returned for a postrebound visit were in remission or LDA at that visit, and nearly half had resumed use of their original TNFi by the time of the visit.
The U.S.-based Corrona registry has registered about 6,000 PsA patients from around 500 rheumatologists since 2001. The conclusions that can be drawn from the current study, which included patients who started a TNFi between Oct. 1, 2002, and March 21, 2013, are limited by the use of the CDAI, a measure for disease activity in rheumatoid arthritis. The use of the CDAI means that disease features of PsA such as enthesitis, psoriasis, and dactylitis were not captured in the assessment of LDA. “That is a caveat,” Dr. Harrold said.
Other limitations of the study include its sporadic follow-up and the open-label, uncontrolled nature of the TNFi discontinuation, according to Dr. Helliwell.
“There could have been any number of reasons why the drug was stopped, not just because of low disease activity – because of financial reasons, perhaps, adverse events, or ... a switch to another drug,” he said in an interview.
Despite these limitations, Dr. Helliwell said that the study “provides useful data, and it will add to the number of publications on this subject that are already out there, and it is the biggest cohort that’s been published.”
Dr. Harrold and her coauthors said that their findings were consistent with those from other studies, including one that Dr. Helliwell’s group was a part of.
That was a pilot randomized, controlled trial to test the feasibility of drug withdrawal in PsA patients in a stable, low disease state, defined by meeting minimal disease activity criteria. Of the 17 patients randomized, 6 of 11 who were in the withdrawal arm experienced a flare (defined as not meeting minimal disease activity criteria). Of these six patients, two had been receiving methotrexate only and four had been treated with methotrexate plus a biologic, whereas none of the six patients who continued therapy experienced a flare (Clin Rheumatol. 2015;34[8]:1407-12). Dr. Helliwell noted that all patients in the withdrawal arm eventually relapsed.
Another study with similar results from investigators at the University of Erlangen-Nuremberg (Germany) found that out of 26 PsA patients on either methotrexate monotherapy (n = 14) or a TNFi (n = 12), with no musculoskeletal symptoms and minimal skin disease, 20 had disease recurrence at a mean of just 74 days after drug discontinuation (Ann Rheum Dis. 2015;74:655-60).
Investigators for another study from the Corrona registry looked at 325 discontinuations of TNFi therapy while in LDA in 302 PsA patients and found disease rebound in 45% at an estimated median time of about 29 months. This study included a physician’s global assessment of skin psoriasis of 20 or less out of 100 as part of the definition of LDA, in addition to a CDAI score of 10 or less. Current smoking was the only significant predictor of disease rebound in a multivariate analysis. Age, gender, the number of prior TNFis used, or overweight or obese status did not predict disease rebound. CDAI score of 3.2 or greater was just outside the range of statistical significance (RMD Open. 2017;3:e000395).
“I think the message here is: ‘Be very careful discontinuing anti-TNF drugs in people with PsA and low disease activity.’ It’s not the same as rheumatoid arthritis in that respect,” Dr. Helliwell said.
Ultimately, the goal is to determine the characteristics of patients who can either stop or taper drugs such as TNF inhibitors. “I think there are going to be patients who can be tapered off, and there are going to be patients who can’t be,” Dr. Harrold said. Going forward, it will be important to identify which subset of patients are going to flare when taken off medication, such as a TNF inhibitor, particularly because of the diversity of presentations that PsA patients can have, she said.
Dr. Helliwell agreed, saying that, when he is asked whether you can stop a TNFi in PsA patients with LDA, “I say you should taper the drug by increasing the interval between doses or lower the dose, but not discontinue it.”
The Corrona registry has been supported by numerous pharmaceutical companies that manufacture drugs for PsA and rheumatoid arthritis. Dr. Harrold and some of her coinvestigators are employees and shareholders of Corrona. Some authors are employees and shareholders of Amgen, and others reported financial relationships with various pharmaceutical companies. Dr. Helliwell has received grant or research support, consulted for, or served on the speakers bureau for many of the companies that support Corrona.
A report on the largest cohort to date of patients with psoriatic arthritis who discontinued tumor necrosis factor inhibitor (TNFi) therapy during a period of low disease activity adds further evidence in support of keeping patients on the biologics during such periods.
The findings from the report on patients with psoriatic arthritis (PsA) from the U.S. Corrona registry found a rebound in disease activity in 69 (73%) of 94 patients. These results are in line with prior small studies, including a pilot, randomized, controlled trial, in PsA patients who have attempted to stop conventional synthetic disease-modifying antirheumatic drugs and biologic DMARDs, mostly TNFi agents, during periods of low disease activity (LDA).
The 73% rate of disease activity rebound observed in the patients – defined by a Clinical Disease Activity Index (CDAI) score of more than 10, a reinitiation of their TNFi, or the start of a new agent – “offers an important perspective for physicians who are considering TNFi discontinuation for patients who have achieved remission/LDA and may provide a key piece of data in discussing the most likely potential outcome with their patients’ TNFi discontinuation,” Dr. Harrold and her associates wrote. “TNFi discontinuation after achieving LDA should be carefully considered.”
The 94 patients with PsA in the Corrona registry study all met study criteria for remission or LDA (CDAI score of 10 or less) and had discontinued their TNFi while in LDA and did not immediately switch to a different biologic. The mean age of the patients was 51; 57% were women and 92% were white. At the time of TNFi initiation, they had an average disease duration of 8.4 years and a mean CDAI score of 10.1, and 64% had LDA. Most patients had taken methotrexate (86%) or a conventional synthetic DMARD (10%) prior to starting a TNFi (J Rheumatol. 2017 Oct 1. doi: 10.3899/jrheum.161567).
Among the 69 patients with rebound of disease activity, 15 had a CDAI score of greater than 10, 24 restarted a biologic DMARD but did not have an elevated CDAI, and 30 had both an elevated CDAI and biologic initiation.
Close to three-quarters of the 59 rebounders who returned for a postrebound visit were in remission or LDA at that visit, and nearly half had resumed use of their original TNFi by the time of the visit.
The U.S.-based Corrona registry has registered about 6,000 PsA patients from around 500 rheumatologists since 2001. The conclusions that can be drawn from the current study, which included patients who started a TNFi between Oct. 1, 2002, and March 21, 2013, are limited by the use of the CDAI, a measure for disease activity in rheumatoid arthritis. The use of the CDAI means that disease features of PsA such as enthesitis, psoriasis, and dactylitis were not captured in the assessment of LDA. “That is a caveat,” Dr. Harrold said.
Other limitations of the study include its sporadic follow-up and the open-label, uncontrolled nature of the TNFi discontinuation, according to Dr. Helliwell.
“There could have been any number of reasons why the drug was stopped, not just because of low disease activity – because of financial reasons, perhaps, adverse events, or ... a switch to another drug,” he said in an interview.
Despite these limitations, Dr. Helliwell said that the study “provides useful data, and it will add to the number of publications on this subject that are already out there, and it is the biggest cohort that’s been published.”
Dr. Harrold and her coauthors said that their findings were consistent with those from other studies, including one that Dr. Helliwell’s group was a part of.
That was a pilot randomized, controlled trial to test the feasibility of drug withdrawal in PsA patients in a stable, low disease state, defined by meeting minimal disease activity criteria. Of the 17 patients randomized, 6 of 11 who were in the withdrawal arm experienced a flare (defined as not meeting minimal disease activity criteria). Of these six patients, two had been receiving methotrexate only and four had been treated with methotrexate plus a biologic, whereas none of the six patients who continued therapy experienced a flare (Clin Rheumatol. 2015;34[8]:1407-12). Dr. Helliwell noted that all patients in the withdrawal arm eventually relapsed.
Another study with similar results from investigators at the University of Erlangen-Nuremberg (Germany) found that out of 26 PsA patients on either methotrexate monotherapy (n = 14) or a TNFi (n = 12), with no musculoskeletal symptoms and minimal skin disease, 20 had disease recurrence at a mean of just 74 days after drug discontinuation (Ann Rheum Dis. 2015;74:655-60).
Investigators for another study from the Corrona registry looked at 325 discontinuations of TNFi therapy while in LDA in 302 PsA patients and found disease rebound in 45% at an estimated median time of about 29 months. This study included a physician’s global assessment of skin psoriasis of 20 or less out of 100 as part of the definition of LDA, in addition to a CDAI score of 10 or less. Current smoking was the only significant predictor of disease rebound in a multivariate analysis. Age, gender, the number of prior TNFis used, or overweight or obese status did not predict disease rebound. CDAI score of 3.2 or greater was just outside the range of statistical significance (RMD Open. 2017;3:e000395).
“I think the message here is: ‘Be very careful discontinuing anti-TNF drugs in people with PsA and low disease activity.’ It’s not the same as rheumatoid arthritis in that respect,” Dr. Helliwell said.
Ultimately, the goal is to determine the characteristics of patients who can either stop or taper drugs such as TNF inhibitors. “I think there are going to be patients who can be tapered off, and there are going to be patients who can’t be,” Dr. Harrold said. Going forward, it will be important to identify which subset of patients are going to flare when taken off medication, such as a TNF inhibitor, particularly because of the diversity of presentations that PsA patients can have, she said.
Dr. Helliwell agreed, saying that, when he is asked whether you can stop a TNFi in PsA patients with LDA, “I say you should taper the drug by increasing the interval between doses or lower the dose, but not discontinue it.”
The Corrona registry has been supported by numerous pharmaceutical companies that manufacture drugs for PsA and rheumatoid arthritis. Dr. Harrold and some of her coinvestigators are employees and shareholders of Corrona. Some authors are employees and shareholders of Amgen, and others reported financial relationships with various pharmaceutical companies. Dr. Helliwell has received grant or research support, consulted for, or served on the speakers bureau for many of the companies that support Corrona.
FROM JOURNAL OF RHEUMATOLOGY
Key clinical point:
Major finding: Among 94 patients, 69 (73%) experienced symptom rebound after discontinuing their TNFi therapy.
Data source: The prospective observational Corrona disease registry database of about 6,000 patients with PsA.
Disclosures: The Corrona registry has been supported by numerous pharmaceutical companies that manufacture drugs for PsA and RA. Dr. Harrold and some of her coinvestigators are employees and shareholders of Corrona. Some authors are employees and shareholders of Amgen, and others reported financial relationships with various pharmaceutical companies. Dr. Helliwell has received grant or research support, consulted for, or served on the speakers bureau for many of the companies that support Corrona.
Translating Research Into Practice the NIOSH Way
The National Occupational Research Agenda (NORA), a partnership program created by the National Institute for Occupational Safety and Health (NIOSH), is celebrating its second anniversary with a report addressing the question: how can research be better moved into practice in the workplace?
NORA has focused on 10 industry sectors representing major areas of the U.S. economy, and developed sector councils—comprising of stakeholders from universities, business, professional societies, government agencies, and worker organizations—that set priority research goals for the nation.
In the past 20 years, NIOSH has had an average of 740 active projects per year. It invested an average of $243.8 million per year in research between 2007 - 2015. Between 2007 - 2014, nearly 11,000 publications were developed through NIOSH-funded research.
Outcome measures include whether those NORA outputs have been used by others, in citations and research. NIOSH says its outputs are widely disseminated; the VA and other veterans’ organizations, for instance, disseminated NIOSH information on return-to-work issues for veterans with PTSD. As another example, academicians and researchers are using NIOSH findings to improve tuberculosis risk and prevention education in workplaces. And approximately 50% of the NIOSH products cited by another federal agency in a Federal Register document were aged ≥ 11 years —suggesting that NIOSH documents have a “sustained relevance and impact well beyond their publication date,” the report says.
NIOSH highlights NORA’s progress with “impact stories” about the influence of NORA on health, safety, and wellbeing of the U.S. workforce. Case in point: “Preventing Occupational Transmission of Blood-borne Pathogens Among Healthcare Workers” helped improve worker safety by instructing > 20,000 trainers and leading to new regulations, NIOSH says.
For its third decade, NIOSH says, NORA will build on the “many successes and lessons learned from the first 2 decades of this unique partnership approach.”
The National Occupational Research Agenda (NORA), a partnership program created by the National Institute for Occupational Safety and Health (NIOSH), is celebrating its second anniversary with a report addressing the question: how can research be better moved into practice in the workplace?
NORA has focused on 10 industry sectors representing major areas of the U.S. economy, and developed sector councils—comprising of stakeholders from universities, business, professional societies, government agencies, and worker organizations—that set priority research goals for the nation.
In the past 20 years, NIOSH has had an average of 740 active projects per year. It invested an average of $243.8 million per year in research between 2007 - 2015. Between 2007 - 2014, nearly 11,000 publications were developed through NIOSH-funded research.
Outcome measures include whether those NORA outputs have been used by others, in citations and research. NIOSH says its outputs are widely disseminated; the VA and other veterans’ organizations, for instance, disseminated NIOSH information on return-to-work issues for veterans with PTSD. As another example, academicians and researchers are using NIOSH findings to improve tuberculosis risk and prevention education in workplaces. And approximately 50% of the NIOSH products cited by another federal agency in a Federal Register document were aged ≥ 11 years —suggesting that NIOSH documents have a “sustained relevance and impact well beyond their publication date,” the report says.
NIOSH highlights NORA’s progress with “impact stories” about the influence of NORA on health, safety, and wellbeing of the U.S. workforce. Case in point: “Preventing Occupational Transmission of Blood-borne Pathogens Among Healthcare Workers” helped improve worker safety by instructing > 20,000 trainers and leading to new regulations, NIOSH says.
For its third decade, NIOSH says, NORA will build on the “many successes and lessons learned from the first 2 decades of this unique partnership approach.”
The National Occupational Research Agenda (NORA), a partnership program created by the National Institute for Occupational Safety and Health (NIOSH), is celebrating its second anniversary with a report addressing the question: how can research be better moved into practice in the workplace?
NORA has focused on 10 industry sectors representing major areas of the U.S. economy, and developed sector councils—comprising of stakeholders from universities, business, professional societies, government agencies, and worker organizations—that set priority research goals for the nation.
In the past 20 years, NIOSH has had an average of 740 active projects per year. It invested an average of $243.8 million per year in research between 2007 - 2015. Between 2007 - 2014, nearly 11,000 publications were developed through NIOSH-funded research.
Outcome measures include whether those NORA outputs have been used by others, in citations and research. NIOSH says its outputs are widely disseminated; the VA and other veterans’ organizations, for instance, disseminated NIOSH information on return-to-work issues for veterans with PTSD. As another example, academicians and researchers are using NIOSH findings to improve tuberculosis risk and prevention education in workplaces. And approximately 50% of the NIOSH products cited by another federal agency in a Federal Register document were aged ≥ 11 years —suggesting that NIOSH documents have a “sustained relevance and impact well beyond their publication date,” the report says.
NIOSH highlights NORA’s progress with “impact stories” about the influence of NORA on health, safety, and wellbeing of the U.S. workforce. Case in point: “Preventing Occupational Transmission of Blood-borne Pathogens Among Healthcare Workers” helped improve worker safety by instructing > 20,000 trainers and leading to new regulations, NIOSH says.
For its third decade, NIOSH says, NORA will build on the “many successes and lessons learned from the first 2 decades of this unique partnership approach.”