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Simple tool improves inpatient influenza vaccination rates
TORONTO –
“When we looked at the immunization status of children in New York City, we found that one of the vaccines most commonly missed was influenza vaccine, especially from 2011 through 2014,” one of the study authors, Anmol Goyal, MD, of SUNY Downstate Medical Center, Brooklyn, N.Y., said in an interview at the Pediatric Academic Societies meeting.
“Given this year’s epidemic of influenza and the increasing deaths, we decided to look back on interventions we had done in the past to see if any can be reimplemented to help improve the vaccination status for these children,” he said. “The national goal is 80%, but if we look at the recent trend, even though we have been able to improve vaccination status, it is still below the national goal.” For example, he said, according to New York Department of Health data, the 2012-2013 influenza vaccination rates in New York City were 65% among children 6 months to 5 years old, 47% among those 5-8 years old, and 31% among those 9-18 years old, which were well below the national goal.
In an effort to improve influenza vaccine access, lead author Stephan Kohlhoff, MD, a pediatric infectious disease specialist at the medical center, and his associates, implemented a simple vaccine screening tool to use in the inpatient setting as an opportunity to improve vaccination rates among children in New York City. It consisted of nursing staff assessing the patient’s influenza immunization status on admission and conducting source verification using the citywide immunization registry, or with vaccine cards brought by parents or guardians during admission. Influenza vaccine was administered as a standing order before discharge, unless refused by the parents or guardians. The study population comprised 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.
Dr. Goyal, a second-year pediatric resident at the medical center, reported that the influenza vaccination status on admission was positive in only 31% of children in 2011, 30% in 2012, and 34% in 2013. The vaccine screening tool was implemented in 64% of admitted children in 2012 and 70% in 2013. Following implementation, the researchers observed a 5% increase in immunization rates in 2012 and an 11% increase in 2013, with an overall increase of 8% over 2 years (P less than .001). He was quick to point out that the influenza rate could have been improved by an additional 22% had 77% of patients not refused vaccination.
“Unfortunately, as our primary objective was to assess the utility of our screening tool in improving inpatient immunization status, we had very limited data points toward refusal of vaccine,” Dr. Goyal said. “Some of the reasons for refusal that were gathered during screening included preferred vaccination by their primary care provider after discharge. Or, maybe they don’t want the vaccine because they feel that the vaccine will make their kids sick. We don’t have enough data to point to any particular reason. This study provides information on acceptance rate of inpatient immunization, which may be useful for implementing additional educational initiatives to overcome potential barriers and help us reach our national goal.”
The researchers reported having no financial disclosures.
TORONTO –
“When we looked at the immunization status of children in New York City, we found that one of the vaccines most commonly missed was influenza vaccine, especially from 2011 through 2014,” one of the study authors, Anmol Goyal, MD, of SUNY Downstate Medical Center, Brooklyn, N.Y., said in an interview at the Pediatric Academic Societies meeting.
“Given this year’s epidemic of influenza and the increasing deaths, we decided to look back on interventions we had done in the past to see if any can be reimplemented to help improve the vaccination status for these children,” he said. “The national goal is 80%, but if we look at the recent trend, even though we have been able to improve vaccination status, it is still below the national goal.” For example, he said, according to New York Department of Health data, the 2012-2013 influenza vaccination rates in New York City were 65% among children 6 months to 5 years old, 47% among those 5-8 years old, and 31% among those 9-18 years old, which were well below the national goal.
In an effort to improve influenza vaccine access, lead author Stephan Kohlhoff, MD, a pediatric infectious disease specialist at the medical center, and his associates, implemented a simple vaccine screening tool to use in the inpatient setting as an opportunity to improve vaccination rates among children in New York City. It consisted of nursing staff assessing the patient’s influenza immunization status on admission and conducting source verification using the citywide immunization registry, or with vaccine cards brought by parents or guardians during admission. Influenza vaccine was administered as a standing order before discharge, unless refused by the parents or guardians. The study population comprised 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.
Dr. Goyal, a second-year pediatric resident at the medical center, reported that the influenza vaccination status on admission was positive in only 31% of children in 2011, 30% in 2012, and 34% in 2013. The vaccine screening tool was implemented in 64% of admitted children in 2012 and 70% in 2013. Following implementation, the researchers observed a 5% increase in immunization rates in 2012 and an 11% increase in 2013, with an overall increase of 8% over 2 years (P less than .001). He was quick to point out that the influenza rate could have been improved by an additional 22% had 77% of patients not refused vaccination.
“Unfortunately, as our primary objective was to assess the utility of our screening tool in improving inpatient immunization status, we had very limited data points toward refusal of vaccine,” Dr. Goyal said. “Some of the reasons for refusal that were gathered during screening included preferred vaccination by their primary care provider after discharge. Or, maybe they don’t want the vaccine because they feel that the vaccine will make their kids sick. We don’t have enough data to point to any particular reason. This study provides information on acceptance rate of inpatient immunization, which may be useful for implementing additional educational initiatives to overcome potential barriers and help us reach our national goal.”
The researchers reported having no financial disclosures.
TORONTO –
“When we looked at the immunization status of children in New York City, we found that one of the vaccines most commonly missed was influenza vaccine, especially from 2011 through 2014,” one of the study authors, Anmol Goyal, MD, of SUNY Downstate Medical Center, Brooklyn, N.Y., said in an interview at the Pediatric Academic Societies meeting.
“Given this year’s epidemic of influenza and the increasing deaths, we decided to look back on interventions we had done in the past to see if any can be reimplemented to help improve the vaccination status for these children,” he said. “The national goal is 80%, but if we look at the recent trend, even though we have been able to improve vaccination status, it is still below the national goal.” For example, he said, according to New York Department of Health data, the 2012-2013 influenza vaccination rates in New York City were 65% among children 6 months to 5 years old, 47% among those 5-8 years old, and 31% among those 9-18 years old, which were well below the national goal.
In an effort to improve influenza vaccine access, lead author Stephan Kohlhoff, MD, a pediatric infectious disease specialist at the medical center, and his associates, implemented a simple vaccine screening tool to use in the inpatient setting as an opportunity to improve vaccination rates among children in New York City. It consisted of nursing staff assessing the patient’s influenza immunization status on admission and conducting source verification using the citywide immunization registry, or with vaccine cards brought by parents or guardians during admission. Influenza vaccine was administered as a standing order before discharge, unless refused by the parents or guardians. The study population comprised 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.
Dr. Goyal, a second-year pediatric resident at the medical center, reported that the influenza vaccination status on admission was positive in only 31% of children in 2011, 30% in 2012, and 34% in 2013. The vaccine screening tool was implemented in 64% of admitted children in 2012 and 70% in 2013. Following implementation, the researchers observed a 5% increase in immunization rates in 2012 and an 11% increase in 2013, with an overall increase of 8% over 2 years (P less than .001). He was quick to point out that the influenza rate could have been improved by an additional 22% had 77% of patients not refused vaccination.
“Unfortunately, as our primary objective was to assess the utility of our screening tool in improving inpatient immunization status, we had very limited data points toward refusal of vaccine,” Dr. Goyal said. “Some of the reasons for refusal that were gathered during screening included preferred vaccination by their primary care provider after discharge. Or, maybe they don’t want the vaccine because they feel that the vaccine will make their kids sick. We don’t have enough data to point to any particular reason. This study provides information on acceptance rate of inpatient immunization, which may be useful for implementing additional educational initiatives to overcome potential barriers and help us reach our national goal.”
The researchers reported having no financial disclosures.
AT PAS 18
Key clinical point: The inpatient setting can be used to successfully improve influenza vaccine rates.
Major finding: Following implementation of a simple inpatient vaccine screening tool, a 5% increase in immunization rates occurred in 2012 and an 11% increase occurred in 2013.
Study details: A review of 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.
Disclosures: The researchers reported having no financial disclosures.
A New Target for a Flu Vaccine?
Seasonal flu vaccines mainly target an influenza surface protein called hemagglutinin (HA). But new research from National Institute of Health (NIH) studies suggest that it might be better to target a surface protein called neuraminidase (NA) for broader protection.
Researchers analyzed blood samples from people vaccinated against influenza and people who were diagnosed with the 2009 H1N1 virus or H3N2 viruses. The analyses indicated that influenza vaccines rarely induce NA-reactive antibodies, whereas natural influenza infection induces these types of antibodies at least as often as it induces HA-reactive antibodies, the researchers say.
Additional laboratory experiments showed the NA-reactive antibodies induced during natural flu infection were “broadly reactive,” meaning they could potentially protect against diverse strains. To test that theory, the researchers isolated NA-reactive monoclonal antibodies from the patients with H3N2 and H1N1, then administered 13 N2-reactive antibodies to mice and infected the mice with a different H3N2 virus strain. Eleven of the N2-reactive antibodies partially or fully protected the mice. In a similar test of N1-reactive antibodies versus H1N1 virus and H5N1-like virus, 4 of 8 antibodies completely protected against both strains.
Seasonal flu vaccines mainly target an influenza surface protein called hemagglutinin (HA). But new research from National Institute of Health (NIH) studies suggest that it might be better to target a surface protein called neuraminidase (NA) for broader protection.
Researchers analyzed blood samples from people vaccinated against influenza and people who were diagnosed with the 2009 H1N1 virus or H3N2 viruses. The analyses indicated that influenza vaccines rarely induce NA-reactive antibodies, whereas natural influenza infection induces these types of antibodies at least as often as it induces HA-reactive antibodies, the researchers say.
Additional laboratory experiments showed the NA-reactive antibodies induced during natural flu infection were “broadly reactive,” meaning they could potentially protect against diverse strains. To test that theory, the researchers isolated NA-reactive monoclonal antibodies from the patients with H3N2 and H1N1, then administered 13 N2-reactive antibodies to mice and infected the mice with a different H3N2 virus strain. Eleven of the N2-reactive antibodies partially or fully protected the mice. In a similar test of N1-reactive antibodies versus H1N1 virus and H5N1-like virus, 4 of 8 antibodies completely protected against both strains.
Seasonal flu vaccines mainly target an influenza surface protein called hemagglutinin (HA). But new research from National Institute of Health (NIH) studies suggest that it might be better to target a surface protein called neuraminidase (NA) for broader protection.
Researchers analyzed blood samples from people vaccinated against influenza and people who were diagnosed with the 2009 H1N1 virus or H3N2 viruses. The analyses indicated that influenza vaccines rarely induce NA-reactive antibodies, whereas natural influenza infection induces these types of antibodies at least as often as it induces HA-reactive antibodies, the researchers say.
Additional laboratory experiments showed the NA-reactive antibodies induced during natural flu infection were “broadly reactive,” meaning they could potentially protect against diverse strains. To test that theory, the researchers isolated NA-reactive monoclonal antibodies from the patients with H3N2 and H1N1, then administered 13 N2-reactive antibodies to mice and infected the mice with a different H3N2 virus strain. Eleven of the N2-reactive antibodies partially or fully protected the mice. In a similar test of N1-reactive antibodies versus H1N1 virus and H5N1-like virus, 4 of 8 antibodies completely protected against both strains.
Why Iron Can Make Malaria Worse
A National Institute of Health (NIH) research team that may have found the explanation for why iron supplements can sometimes worsen malaria infection. “Our study helps solve a long-standing mystery,” says Tracey Rouault, MD, a member of the team.
The researchers say the answer may lie with ferroportin, a protein that prevents iron from building to toxic levels in red blood cells and helps prevent malaria infection. Red blood cells use ferroportin to remove excess iron (a food source for malaria parasites). When the researchers fed mice a high-iron diet, they found that a hormone called hepcidin regulates ferroportin in erythroid cells. The hormone, which is more abundant in high-iron environments, not only lowered ferroportin levels in erythroblasts and red blood cells, but physically bound to ferroportin, preventing iron from being removed from cells.
Findings from 2 malaria studies suggest that Q248H, a ferroportin mutation often found in malaria-endemic regions, protects against malaria. In 1 study, nearly 20% of 66 children hospitalized for malaria in Zambia had the mutation; these children also tended to have fewer malarial parasites in the blood and tolerated their fevers for a longer period before coming to the hospital.
In the other study, of 290 pregnant women in Ghana, nearly 9% had the mutation. Those women were significantly less likely to have pregnancy-associated malaria.
Rouault says the findings may help explain why iron supplements can sometimes worsen malaria infection and why, conversely, iron deficiency can sometimes be protective. The findings also may help researchers develop strategies to prevent and treat malarial infections, which numbered nearly 216 million in 2016.
A National Institute of Health (NIH) research team that may have found the explanation for why iron supplements can sometimes worsen malaria infection. “Our study helps solve a long-standing mystery,” says Tracey Rouault, MD, a member of the team.
The researchers say the answer may lie with ferroportin, a protein that prevents iron from building to toxic levels in red blood cells and helps prevent malaria infection. Red blood cells use ferroportin to remove excess iron (a food source for malaria parasites). When the researchers fed mice a high-iron diet, they found that a hormone called hepcidin regulates ferroportin in erythroid cells. The hormone, which is more abundant in high-iron environments, not only lowered ferroportin levels in erythroblasts and red blood cells, but physically bound to ferroportin, preventing iron from being removed from cells.
Findings from 2 malaria studies suggest that Q248H, a ferroportin mutation often found in malaria-endemic regions, protects against malaria. In 1 study, nearly 20% of 66 children hospitalized for malaria in Zambia had the mutation; these children also tended to have fewer malarial parasites in the blood and tolerated their fevers for a longer period before coming to the hospital.
In the other study, of 290 pregnant women in Ghana, nearly 9% had the mutation. Those women were significantly less likely to have pregnancy-associated malaria.
Rouault says the findings may help explain why iron supplements can sometimes worsen malaria infection and why, conversely, iron deficiency can sometimes be protective. The findings also may help researchers develop strategies to prevent and treat malarial infections, which numbered nearly 216 million in 2016.
A National Institute of Health (NIH) research team that may have found the explanation for why iron supplements can sometimes worsen malaria infection. “Our study helps solve a long-standing mystery,” says Tracey Rouault, MD, a member of the team.
The researchers say the answer may lie with ferroportin, a protein that prevents iron from building to toxic levels in red blood cells and helps prevent malaria infection. Red blood cells use ferroportin to remove excess iron (a food source for malaria parasites). When the researchers fed mice a high-iron diet, they found that a hormone called hepcidin regulates ferroportin in erythroid cells. The hormone, which is more abundant in high-iron environments, not only lowered ferroportin levels in erythroblasts and red blood cells, but physically bound to ferroportin, preventing iron from being removed from cells.
Findings from 2 malaria studies suggest that Q248H, a ferroportin mutation often found in malaria-endemic regions, protects against malaria. In 1 study, nearly 20% of 66 children hospitalized for malaria in Zambia had the mutation; these children also tended to have fewer malarial parasites in the blood and tolerated their fevers for a longer period before coming to the hospital.
In the other study, of 290 pregnant women in Ghana, nearly 9% had the mutation. Those women were significantly less likely to have pregnancy-associated malaria.
Rouault says the findings may help explain why iron supplements can sometimes worsen malaria infection and why, conversely, iron deficiency can sometimes be protective. The findings also may help researchers develop strategies to prevent and treat malarial infections, which numbered nearly 216 million in 2016.
Study Reaffirms Tenofovir’s Safety for Pregnant Women
A reanalysis of 2 National Institutes of Health (NIH)-funded studies refutes the conclusions of PROMISE (Promoting Maternal and Infant Survival Everywhere), which found tenofovir disoproxil fumarate (TDF) combination treatment raised the risk of adverse outcomes.
The PROMISE study compared several treatments in pregnant women with HIV in India and Africa. According to those researchers, women on TDF regimens were twice as likely as those on zidovudine to have a very preterm infant, and their infants were more likely to die within the first 2 weeks.
Those results surprised the current researchers, given that other, earlier studies had found TDF combinations safe for use during pregnancy. In fact, the World Health Organization recommends that all adults with HIV, including pregnant women, receive TDF combination therapy.
In the current study, NIH researchers compared outcomes from 2 US studies, reviewing records on more than 4,600 infants born to 3,847 women. The women were on either a combination regimen including zidovudine or 1 containing TDF.
The researchers found no significant differences in the risk of preterm birth or low birth weight, nor did they find any significant difference in severe birth outcomes, including infant death, in the first 2 weeks. “Notably,” they add, comparing women on zidovudine combination treatment with TDF/emtricitabine/atazanavir/ritonavir, the researchers found the TDF group had a 10% lower chance of preterm birth, low birth weight, and infant death.
Source:
National Institutes of Health. https://www.nih.gov/news-events/news-releases/anti-hiv-drug-combination-does-not-increase-preterm-birth-risk-study-suggests. Published April 25, 2018. Accessed May 24, 2018.
A reanalysis of 2 National Institutes of Health (NIH)-funded studies refutes the conclusions of PROMISE (Promoting Maternal and Infant Survival Everywhere), which found tenofovir disoproxil fumarate (TDF) combination treatment raised the risk of adverse outcomes.
The PROMISE study compared several treatments in pregnant women with HIV in India and Africa. According to those researchers, women on TDF regimens were twice as likely as those on zidovudine to have a very preterm infant, and their infants were more likely to die within the first 2 weeks.
Those results surprised the current researchers, given that other, earlier studies had found TDF combinations safe for use during pregnancy. In fact, the World Health Organization recommends that all adults with HIV, including pregnant women, receive TDF combination therapy.
In the current study, NIH researchers compared outcomes from 2 US studies, reviewing records on more than 4,600 infants born to 3,847 women. The women were on either a combination regimen including zidovudine or 1 containing TDF.
The researchers found no significant differences in the risk of preterm birth or low birth weight, nor did they find any significant difference in severe birth outcomes, including infant death, in the first 2 weeks. “Notably,” they add, comparing women on zidovudine combination treatment with TDF/emtricitabine/atazanavir/ritonavir, the researchers found the TDF group had a 10% lower chance of preterm birth, low birth weight, and infant death.
Source:
National Institutes of Health. https://www.nih.gov/news-events/news-releases/anti-hiv-drug-combination-does-not-increase-preterm-birth-risk-study-suggests. Published April 25, 2018. Accessed May 24, 2018.
A reanalysis of 2 National Institutes of Health (NIH)-funded studies refutes the conclusions of PROMISE (Promoting Maternal and Infant Survival Everywhere), which found tenofovir disoproxil fumarate (TDF) combination treatment raised the risk of adverse outcomes.
The PROMISE study compared several treatments in pregnant women with HIV in India and Africa. According to those researchers, women on TDF regimens were twice as likely as those on zidovudine to have a very preterm infant, and their infants were more likely to die within the first 2 weeks.
Those results surprised the current researchers, given that other, earlier studies had found TDF combinations safe for use during pregnancy. In fact, the World Health Organization recommends that all adults with HIV, including pregnant women, receive TDF combination therapy.
In the current study, NIH researchers compared outcomes from 2 US studies, reviewing records on more than 4,600 infants born to 3,847 women. The women were on either a combination regimen including zidovudine or 1 containing TDF.
The researchers found no significant differences in the risk of preterm birth or low birth weight, nor did they find any significant difference in severe birth outcomes, including infant death, in the first 2 weeks. “Notably,” they add, comparing women on zidovudine combination treatment with TDF/emtricitabine/atazanavir/ritonavir, the researchers found the TDF group had a 10% lower chance of preterm birth, low birth weight, and infant death.
Source:
National Institutes of Health. https://www.nih.gov/news-events/news-releases/anti-hiv-drug-combination-does-not-increase-preterm-birth-risk-study-suggests. Published April 25, 2018. Accessed May 24, 2018.
The ‘Other’ Risks of High Blood Pressure
Other cardiovascular disease outcomes, such as kidney disease and dementia, are less known than the “tradional” outcomes, such as heart attack, heart failure, and stroke. In a Centers for Disease Control and Prevention (CDC) study of 4,166 adults, only 38.5% of those with self-reported hypertension were aware of the risk of kidney disease, versus 24.8% of normotensive adults. Awareness of the risk of dementia was “markedly low”: 8.7% and 7.9%, respectively.
The researchers found “notable” socioeconomic and racial/ethnic differences in awareness of risks. For example, high-income respondents had greater awareness of the association between uncontrolled hypertension and kidney disease, stroke, and dementia, when compared with low-income respondents. Non-Hispanic whites had greater awareness of risk than non-Hispanic blacks (who have a higher prevalence of hypertension and uncontrolled hypertension).
Nearly 35 million people have uncontrolled hypertension, the researchers note. To educate more diverse patient populations about the risks, they recommend expanding current initiatives such as the “Mind Your Risks” program (https://mindyourrisks.nih.gov), promoted by the National Institute of Neurological Disorders and Stroke; and the “Measure Up/Pressure Down (www.measureuppressuredown.com) program, sponsored by the American Medical Group Association.
Other cardiovascular disease outcomes, such as kidney disease and dementia, are less known than the “tradional” outcomes, such as heart attack, heart failure, and stroke. In a Centers for Disease Control and Prevention (CDC) study of 4,166 adults, only 38.5% of those with self-reported hypertension were aware of the risk of kidney disease, versus 24.8% of normotensive adults. Awareness of the risk of dementia was “markedly low”: 8.7% and 7.9%, respectively.
The researchers found “notable” socioeconomic and racial/ethnic differences in awareness of risks. For example, high-income respondents had greater awareness of the association between uncontrolled hypertension and kidney disease, stroke, and dementia, when compared with low-income respondents. Non-Hispanic whites had greater awareness of risk than non-Hispanic blacks (who have a higher prevalence of hypertension and uncontrolled hypertension).
Nearly 35 million people have uncontrolled hypertension, the researchers note. To educate more diverse patient populations about the risks, they recommend expanding current initiatives such as the “Mind Your Risks” program (https://mindyourrisks.nih.gov), promoted by the National Institute of Neurological Disorders and Stroke; and the “Measure Up/Pressure Down (www.measureuppressuredown.com) program, sponsored by the American Medical Group Association.
Other cardiovascular disease outcomes, such as kidney disease and dementia, are less known than the “tradional” outcomes, such as heart attack, heart failure, and stroke. In a Centers for Disease Control and Prevention (CDC) study of 4,166 adults, only 38.5% of those with self-reported hypertension were aware of the risk of kidney disease, versus 24.8% of normotensive adults. Awareness of the risk of dementia was “markedly low”: 8.7% and 7.9%, respectively.
The researchers found “notable” socioeconomic and racial/ethnic differences in awareness of risks. For example, high-income respondents had greater awareness of the association between uncontrolled hypertension and kidney disease, stroke, and dementia, when compared with low-income respondents. Non-Hispanic whites had greater awareness of risk than non-Hispanic blacks (who have a higher prevalence of hypertension and uncontrolled hypertension).
Nearly 35 million people have uncontrolled hypertension, the researchers note. To educate more diverse patient populations about the risks, they recommend expanding current initiatives such as the “Mind Your Risks” program (https://mindyourrisks.nih.gov), promoted by the National Institute of Neurological Disorders and Stroke; and the “Measure Up/Pressure Down (www.measureuppressuredown.com) program, sponsored by the American Medical Group Association.
Older CLL and NHL patients are more vulnerable to toxicities
Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.
An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).
Investigators analyzed data obtained from the Alliance for Clinical Trials in Oncology to compare the incidence of toxicities between age groups. Of the 1,199 patients included in the analysis, 409 were 65 years of age or older, and 790 were younger than 65 years. Among these patients, 438 received only therapy with novel agents including biologic combinations, monoclonal antibodies, cell cycle inhibitors, chemoimmunotherapy, and immunomodulators, and 761 received novel agents in addition to chemotherapy.
Overall, 68% of CLL patients and 35% of NHL patients had at least one grade three or four hematologic toxicity, compared with 48% and 54% for nonhematologic toxicities, respectively.
Older CLL patients with at least one grade three or four toxicity in the first 3 months had similar overall survival (OS) and progression-free survival (PFS) as those without a toxicity. In contrast, older NHL patients with at least one grade three or four hematologic toxicity in the first 3 months had worse OS (HR, 3.14; P = .006; 95% CI, 2.25-4.39) and PFS (HR, 3.06; P = .011; 95% CI, 2.10-4.45) than patients without these toxicities. Nonhematologic toxicities were not significantly associated with survival outcomes for patients with NHL.
“The observed associations between hematologic toxicity and OS/PFS among older patients with NHL require further investigation,” the researchers wrote. “These findings could represent a direct effect of toxicity due to decreased physiologic reserve, decreased drug clearance, or an increased sensitivity of tissue to novel agents.”
The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.
SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.
Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.
An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).
Investigators analyzed data obtained from the Alliance for Clinical Trials in Oncology to compare the incidence of toxicities between age groups. Of the 1,199 patients included in the analysis, 409 were 65 years of age or older, and 790 were younger than 65 years. Among these patients, 438 received only therapy with novel agents including biologic combinations, monoclonal antibodies, cell cycle inhibitors, chemoimmunotherapy, and immunomodulators, and 761 received novel agents in addition to chemotherapy.
Overall, 68% of CLL patients and 35% of NHL patients had at least one grade three or four hematologic toxicity, compared with 48% and 54% for nonhematologic toxicities, respectively.
Older CLL patients with at least one grade three or four toxicity in the first 3 months had similar overall survival (OS) and progression-free survival (PFS) as those without a toxicity. In contrast, older NHL patients with at least one grade three or four hematologic toxicity in the first 3 months had worse OS (HR, 3.14; P = .006; 95% CI, 2.25-4.39) and PFS (HR, 3.06; P = .011; 95% CI, 2.10-4.45) than patients without these toxicities. Nonhematologic toxicities were not significantly associated with survival outcomes for patients with NHL.
“The observed associations between hematologic toxicity and OS/PFS among older patients with NHL require further investigation,” the researchers wrote. “These findings could represent a direct effect of toxicity due to decreased physiologic reserve, decreased drug clearance, or an increased sensitivity of tissue to novel agents.”
The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.
SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.
Older patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) have an increased odds of experiencing treatment-related toxicities, even when treated with novel agents, according to findings reported in the Journal of Geriatric Oncology.
An analysis of 1,199 patients showed that CLL patients aged 65 years and older had significantly higher odds than younger patients of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI, 1.39-1.55).
Investigators analyzed data obtained from the Alliance for Clinical Trials in Oncology to compare the incidence of toxicities between age groups. Of the 1,199 patients included in the analysis, 409 were 65 years of age or older, and 790 were younger than 65 years. Among these patients, 438 received only therapy with novel agents including biologic combinations, monoclonal antibodies, cell cycle inhibitors, chemoimmunotherapy, and immunomodulators, and 761 received novel agents in addition to chemotherapy.
Overall, 68% of CLL patients and 35% of NHL patients had at least one grade three or four hematologic toxicity, compared with 48% and 54% for nonhematologic toxicities, respectively.
Older CLL patients with at least one grade three or four toxicity in the first 3 months had similar overall survival (OS) and progression-free survival (PFS) as those without a toxicity. In contrast, older NHL patients with at least one grade three or four hematologic toxicity in the first 3 months had worse OS (HR, 3.14; P = .006; 95% CI, 2.25-4.39) and PFS (HR, 3.06; P = .011; 95% CI, 2.10-4.45) than patients without these toxicities. Nonhematologic toxicities were not significantly associated with survival outcomes for patients with NHL.
“The observed associations between hematologic toxicity and OS/PFS among older patients with NHL require further investigation,” the researchers wrote. “These findings could represent a direct effect of toxicity due to decreased physiologic reserve, decreased drug clearance, or an increased sensitivity of tissue to novel agents.”
The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.
SOURCE: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.
FROM THE JOURNAL OF GERIATRIC ONCOLOGY
Key clinical point:
Major finding: Older CLL patients had significantly higher odds of developing a grade three or four hematologic toxicity (adjusted odds ratio, 1.70; P = .009; 95% confidence interval, 1.57-1.84) or nonhematologic toxicity (OR, 1.47; P = .022; 95% CI 1.39-1.55).
Study details: An analysis of data from 1,199 CLL and NHL patients in the Alliance for Clinical Trials in Oncology.
Disclosures: The study was supported by a National Institutes of Health grant. Researchers reported relationships with Bartlett, KITE, Pfizer, Seattle Genetics, Roche-Genentech, Celgene, Pharmacyclics, and Gilead.
Source: Tallarico M et al. J Geriatr Oncol. 2018 Apr 16. pii: S1879-4068(18)30131-0.
How to Eliminate TB—Faster
The US goal is to get Tuberculosis (TB) rates down to > 1 case per 1 million people, but in 2017 there were 28 cases per million. After years of decline, TB rates have stagnated among people born in the US. The TB rate dropped slightly (–2.5%) from 2016 to 2017. Another even slighter decrease was seen in 2017 (–1.8%). Moreover, < 1 in 10 TB cases occurred among children aged < 15 years (a “key marker” of recent transmission, the CDC says). Half of all cases were reported in California, New York, Texas, and Florida, all 4 corners of the country.
As many as 13 million people in the US have latent TB infection but the vast majority do not know it. On average, 5% - 10% of people with latent TB infection progress to infectious TB. More than 80% of US TB cases are associated with long-standing, untreated latent TB infections.
The CDC says reaching the elimination goal will take an “intensified, dual approach” that strengthens existing systems to prevent transmission of infectious TB disease and increases efforts to detect and treat latent infection before it progresses to infectious TB.
It is essential to ensure that every active case of TB disease is effectively detected and treated, the CDC says. Treatments can be difficult to complete; however, not completing treatment can lead to drug-resistant bacteria, and even lengthier and more expensive treatment. CDC research has identified a shorter regimen for people with latent infection: 12 once-weekly doses of isoniazid and rifapentine, a simpler treatment compared with other regimens that include a 270-dose, and 9-month daily regimen of isoniazid.
Over the past 20 years, health departments and CDC TB control efforts have prevented an estimated 300,000 cases of TB disease. “Challenges remain,” says Philip LoBue, MD, director of CDC’s Division of Tuberculosis Elimination. But “[t]he good news is that the path to accelerated progress is clear.” In addition to the shorter treatment regimen, recent advances include electronic directly observed therapy (eDOT), which makes TB treatment less expensive and more convenient; and a diagnostic blood test that can provide accurate results in a single medical visit.
The US goal is to get Tuberculosis (TB) rates down to > 1 case per 1 million people, but in 2017 there were 28 cases per million. After years of decline, TB rates have stagnated among people born in the US. The TB rate dropped slightly (–2.5%) from 2016 to 2017. Another even slighter decrease was seen in 2017 (–1.8%). Moreover, < 1 in 10 TB cases occurred among children aged < 15 years (a “key marker” of recent transmission, the CDC says). Half of all cases were reported in California, New York, Texas, and Florida, all 4 corners of the country.
As many as 13 million people in the US have latent TB infection but the vast majority do not know it. On average, 5% - 10% of people with latent TB infection progress to infectious TB. More than 80% of US TB cases are associated with long-standing, untreated latent TB infections.
The CDC says reaching the elimination goal will take an “intensified, dual approach” that strengthens existing systems to prevent transmission of infectious TB disease and increases efforts to detect and treat latent infection before it progresses to infectious TB.
It is essential to ensure that every active case of TB disease is effectively detected and treated, the CDC says. Treatments can be difficult to complete; however, not completing treatment can lead to drug-resistant bacteria, and even lengthier and more expensive treatment. CDC research has identified a shorter regimen for people with latent infection: 12 once-weekly doses of isoniazid and rifapentine, a simpler treatment compared with other regimens that include a 270-dose, and 9-month daily regimen of isoniazid.
Over the past 20 years, health departments and CDC TB control efforts have prevented an estimated 300,000 cases of TB disease. “Challenges remain,” says Philip LoBue, MD, director of CDC’s Division of Tuberculosis Elimination. But “[t]he good news is that the path to accelerated progress is clear.” In addition to the shorter treatment regimen, recent advances include electronic directly observed therapy (eDOT), which makes TB treatment less expensive and more convenient; and a diagnostic blood test that can provide accurate results in a single medical visit.
The US goal is to get Tuberculosis (TB) rates down to > 1 case per 1 million people, but in 2017 there were 28 cases per million. After years of decline, TB rates have stagnated among people born in the US. The TB rate dropped slightly (–2.5%) from 2016 to 2017. Another even slighter decrease was seen in 2017 (–1.8%). Moreover, < 1 in 10 TB cases occurred among children aged < 15 years (a “key marker” of recent transmission, the CDC says). Half of all cases were reported in California, New York, Texas, and Florida, all 4 corners of the country.
As many as 13 million people in the US have latent TB infection but the vast majority do not know it. On average, 5% - 10% of people with latent TB infection progress to infectious TB. More than 80% of US TB cases are associated with long-standing, untreated latent TB infections.
The CDC says reaching the elimination goal will take an “intensified, dual approach” that strengthens existing systems to prevent transmission of infectious TB disease and increases efforts to detect and treat latent infection before it progresses to infectious TB.
It is essential to ensure that every active case of TB disease is effectively detected and treated, the CDC says. Treatments can be difficult to complete; however, not completing treatment can lead to drug-resistant bacteria, and even lengthier and more expensive treatment. CDC research has identified a shorter regimen for people with latent infection: 12 once-weekly doses of isoniazid and rifapentine, a simpler treatment compared with other regimens that include a 270-dose, and 9-month daily regimen of isoniazid.
Over the past 20 years, health departments and CDC TB control efforts have prevented an estimated 300,000 cases of TB disease. “Challenges remain,” says Philip LoBue, MD, director of CDC’s Division of Tuberculosis Elimination. But “[t]he good news is that the path to accelerated progress is clear.” In addition to the shorter treatment regimen, recent advances include electronic directly observed therapy (eDOT), which makes TB treatment less expensive and more convenient; and a diagnostic blood test that can provide accurate results in a single medical visit.
In-hospital mortality predictors eyed in pneumonia patient subset
SAN DIEGO –, results from a large retrospective cohort study found.
In a poster abstract presented at an international conference of the American Thoracic Society, researchers led by Thomas P. Lodise Jr., PharmD, noted that ventilator-associated pneumonia is one of the most common hospital-acquired infections in intensive care units and affected an estimated 9%-27% of all intubated patients. “While data are readily available surrounding mortality associated with VAP, scant data are available on outcomes associated with any type of pneumonia requiring intubation and mechanical ventilation (MV) caused by gram-negative organisms,” they wrote.
In an effort to describe mortality rates and associated risk factors for intubated and MV patients diagnosed with gram-negative pneumonia, Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences and his associates conducted a retrospective cohort study of data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database (NRD). HCUP is the largest source of hospital care data in the United States, accounting for 49.3% of the total U.S. resident population and 49.1% of U.S. hospitalizations. The researchers included patients at least 18 years of age who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia between Feb. 1, 2013, and Nov. 30, 2013. They excluded index hospitalizations with a primary or secondary diagnosis of viral pneumonia, fungal pneumonia, atypical organisms, gram-positive bacterial pneumonia, or pneumonia occurring secondary to an infectious disease. They examined mortality rates descriptively and modeled them via adjusted multivariate logistic regression to evaluate the impact of baseline characteristics and comorbidities on risk of mortality. All analyses incorporated sample weights to increase generalizability and allow for extrapolation to the entire U.S. population.
A total of 32,683 patients met all study criteria. Of these, 2,323 (7.1%) had a primary diagnosis and 30,360 (92.9%) had a secondary diagnosis for gram-negative pneumonia. Their mean age was 64 years, and 61.1% were male. In all, 7,928 patients (24.3%) died during hospitalization. Multivariate analysis revealed that patients with concomitant sepsis had the highest risk of mortality (odds ratio, 2.60), followed by patients aged 65 years and older (OR, 1.88) and those with any prior hospitalization within 30 days (OR, 1.34). Comorbidities upon admission with highest risk of mortality included cancer (OR, 2.45), liver disease (OR, 1.91), AIDS/HIV (OR, 1.59), renal disease (OR, 1.33), and congestive heart failure (OR, 1.15). Diabetes was found to have a decreased risk of mortality, with an OR of 0.80. “However, a majority of patients with diabetes had no complications; thus, these patients may be representative of a less severe patient population,” Dr. Lodise and his associates noted in the poster.
They acknowledged certain limitations of the study, including the potential for coding errors. They also pointed out the HCUP NRD does not contain treatment-specific information, drugs administered or treatment patterns during hospitalization, the number of days patients spent in the ICU, or the number of days on ventilation, “which can influence outcomes in pneumonia patients.” In addition, the study did not attempt to determine cause of death. “Death may have been due to combinations of factors separate from pneumonia,” they wrote.
Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.
dbrunk@mdedge.com
SOURCE: Lodise T. et al. ATS 2018, Poster 272.
SAN DIEGO –, results from a large retrospective cohort study found.
In a poster abstract presented at an international conference of the American Thoracic Society, researchers led by Thomas P. Lodise Jr., PharmD, noted that ventilator-associated pneumonia is one of the most common hospital-acquired infections in intensive care units and affected an estimated 9%-27% of all intubated patients. “While data are readily available surrounding mortality associated with VAP, scant data are available on outcomes associated with any type of pneumonia requiring intubation and mechanical ventilation (MV) caused by gram-negative organisms,” they wrote.
In an effort to describe mortality rates and associated risk factors for intubated and MV patients diagnosed with gram-negative pneumonia, Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences and his associates conducted a retrospective cohort study of data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database (NRD). HCUP is the largest source of hospital care data in the United States, accounting for 49.3% of the total U.S. resident population and 49.1% of U.S. hospitalizations. The researchers included patients at least 18 years of age who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia between Feb. 1, 2013, and Nov. 30, 2013. They excluded index hospitalizations with a primary or secondary diagnosis of viral pneumonia, fungal pneumonia, atypical organisms, gram-positive bacterial pneumonia, or pneumonia occurring secondary to an infectious disease. They examined mortality rates descriptively and modeled them via adjusted multivariate logistic regression to evaluate the impact of baseline characteristics and comorbidities on risk of mortality. All analyses incorporated sample weights to increase generalizability and allow for extrapolation to the entire U.S. population.
A total of 32,683 patients met all study criteria. Of these, 2,323 (7.1%) had a primary diagnosis and 30,360 (92.9%) had a secondary diagnosis for gram-negative pneumonia. Their mean age was 64 years, and 61.1% were male. In all, 7,928 patients (24.3%) died during hospitalization. Multivariate analysis revealed that patients with concomitant sepsis had the highest risk of mortality (odds ratio, 2.60), followed by patients aged 65 years and older (OR, 1.88) and those with any prior hospitalization within 30 days (OR, 1.34). Comorbidities upon admission with highest risk of mortality included cancer (OR, 2.45), liver disease (OR, 1.91), AIDS/HIV (OR, 1.59), renal disease (OR, 1.33), and congestive heart failure (OR, 1.15). Diabetes was found to have a decreased risk of mortality, with an OR of 0.80. “However, a majority of patients with diabetes had no complications; thus, these patients may be representative of a less severe patient population,” Dr. Lodise and his associates noted in the poster.
They acknowledged certain limitations of the study, including the potential for coding errors. They also pointed out the HCUP NRD does not contain treatment-specific information, drugs administered or treatment patterns during hospitalization, the number of days patients spent in the ICU, or the number of days on ventilation, “which can influence outcomes in pneumonia patients.” In addition, the study did not attempt to determine cause of death. “Death may have been due to combinations of factors separate from pneumonia,” they wrote.
Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.
dbrunk@mdedge.com
SOURCE: Lodise T. et al. ATS 2018, Poster 272.
SAN DIEGO –, results from a large retrospective cohort study found.
In a poster abstract presented at an international conference of the American Thoracic Society, researchers led by Thomas P. Lodise Jr., PharmD, noted that ventilator-associated pneumonia is one of the most common hospital-acquired infections in intensive care units and affected an estimated 9%-27% of all intubated patients. “While data are readily available surrounding mortality associated with VAP, scant data are available on outcomes associated with any type of pneumonia requiring intubation and mechanical ventilation (MV) caused by gram-negative organisms,” they wrote.
In an effort to describe mortality rates and associated risk factors for intubated and MV patients diagnosed with gram-negative pneumonia, Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences and his associates conducted a retrospective cohort study of data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database (NRD). HCUP is the largest source of hospital care data in the United States, accounting for 49.3% of the total U.S. resident population and 49.1% of U.S. hospitalizations. The researchers included patients at least 18 years of age who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia between Feb. 1, 2013, and Nov. 30, 2013. They excluded index hospitalizations with a primary or secondary diagnosis of viral pneumonia, fungal pneumonia, atypical organisms, gram-positive bacterial pneumonia, or pneumonia occurring secondary to an infectious disease. They examined mortality rates descriptively and modeled them via adjusted multivariate logistic regression to evaluate the impact of baseline characteristics and comorbidities on risk of mortality. All analyses incorporated sample weights to increase generalizability and allow for extrapolation to the entire U.S. population.
A total of 32,683 patients met all study criteria. Of these, 2,323 (7.1%) had a primary diagnosis and 30,360 (92.9%) had a secondary diagnosis for gram-negative pneumonia. Their mean age was 64 years, and 61.1% were male. In all, 7,928 patients (24.3%) died during hospitalization. Multivariate analysis revealed that patients with concomitant sepsis had the highest risk of mortality (odds ratio, 2.60), followed by patients aged 65 years and older (OR, 1.88) and those with any prior hospitalization within 30 days (OR, 1.34). Comorbidities upon admission with highest risk of mortality included cancer (OR, 2.45), liver disease (OR, 1.91), AIDS/HIV (OR, 1.59), renal disease (OR, 1.33), and congestive heart failure (OR, 1.15). Diabetes was found to have a decreased risk of mortality, with an OR of 0.80. “However, a majority of patients with diabetes had no complications; thus, these patients may be representative of a less severe patient population,” Dr. Lodise and his associates noted in the poster.
They acknowledged certain limitations of the study, including the potential for coding errors. They also pointed out the HCUP NRD does not contain treatment-specific information, drugs administered or treatment patterns during hospitalization, the number of days patients spent in the ICU, or the number of days on ventilation, “which can influence outcomes in pneumonia patients.” In addition, the study did not attempt to determine cause of death. “Death may have been due to combinations of factors separate from pneumonia,” they wrote.
Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.
dbrunk@mdedge.com
SOURCE: Lodise T. et al. ATS 2018, Poster 272.
AT ATS 2018
Key clinical point: Before this analysis, mortality and associated risk factors for intubated or mechanically ventilated patients diagnosed with gram-negative pneumonia were poorly understood.
Major finding: Among hospitalized, intubated or mechanically ventilated patients with gram-negative pneumonia, 24.3% died during their hospital stay.
Study details: A retrospective cohort study of data from 32,683 patients who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia.
Disclosures: Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.
Source: Lodise T. et al. ATS 2018, Poster 272.
Four-meter gait speed predicts mortality in IPF
SAN DIEGO – Among patients with idiopathic pulmonary fibrosis (IPF), an improvement in 4-meter gait speed with pulmonary rehabilitation is an independent predictor of all-cause mortality at 1 year, suggest results from a multicenter study presented at an international conference of the American Thoracic Society.
In all, 11% of patients died within 1 year of completing pulmonary rehabilitation.
“Mortality is an attractive endpoint in IPF clinical research but requires large sample sizes and long follow-up duration, making clinical trials expensive and challenging to undertake,” lead study author Claire M. Nolan, MSc, said at the conference.
“Consequently, there is much interest in surrogate endpoints of mortality. In the elderly population, a lot of work has been done on performance measures, in particular the 4-meter gait test. It’s a simple test to do from the assessor’s perspective, because you just need a 4-meter corridor and a stopwatch. From the patient’s perspective, they only have to walk at their usual speed, making it feasible in most settings.”
The study by Ms. Nolan, a National Institute for Health Research fellow, and her associates, involved recruiting 90 IPF patients referred to three outpatient pulmonary rehabilitation programs in London. All patients underwent the following assessments before and after 8 weeks of pulmonary rehabilitation: spirometry; Medical Research Council dyspnea score; anthropometry; 4-meter gait speed; incremental shuttle walk test, and King’s Brief Interstitial Lung Disease questionnaire. Ms. Nolan, a respiratory physiotherapist with the Harefield Pulmonary Rehabilitation and Muscle Research Group, Royal Brompton and Harefield NHS Foundation Trust, Harefield, London, and her associates drew from national databases to obtain data on all-cause mortality 1 year following pulmonary rehabilitation.
“We also identified a cutpoint, so if patients improved their walking speed by 0.009 meters per second or above, that was associated with a longer survival time at 1 year (area under the curve of 0.76, for sensitivity of 69.6% and a specificity of 70%; P less than 0.01),” she said.* “Among patients who achieved that cutpoint or exceeded it, only 5% of them died in the 1-year follow-up period, compared with 23% in the group that didn’t achieve that cutpoint. That’s quite a big difference, but this requires external validation in another population.”
To determine the 4-meter gait speed change cut-off that best discriminated between patients who died and survived, the investigators plotted receiver operating characteristic curves. For validation, they conducted a Kaplan-Meier analysis to assess time to death, with significance assessed via the log-rank test. Finally, they used a multivariate Cox proportional hazards model to characterize the relationship between 4-meter gait speed change and all-cause mortality, adjusting for independent predictors of mortality (age, previous respiratory hospitalizations in the past year, forced vital capacity percent predicted) and baseline 4-meter gait speed.
At baseline, 70% of the 90 patients were male, mean age was 74 years, mean forced vital capacity was 72.8% predicted, and mean Medical Research Council dyspnea score was 3. In addition, mean body mass index was 27.2 kg/m2, mean 4-meter gait speed was 0.92 meters per second, mean incremental shuttle walk test measurement was 271 meters, and mean King’s Brief Interstitial Lung Disease total score was 56.4. Following 8 weeks of pulmonary rehabilitation, the patients’ 4-meter gait speed improved significantly by a mean of 0.15 meters per second (P less than .001). All other variables also improved significantly, with the exception of forced vital capacity.
In an interview, Ms. Nolan characterized the results as “one piece of the puzzle in answering whether 4-meter gait speed is a useful test for clinicians and researchers. It needs to be taken in the context of 4-meter gait speed in other populations as well as with what we’re finding in patients with IPF. We know that this test is reliable, valid, and responsive to treatment. Now we know that it has predictive capacity as well.”
During her presentation, she cited potential reasons why change in gait speed is associated with survival. “Firstly, gait speed has been described as a clinical indicator of multisystem well-being and the ‘sixth vital sign,’ ”she said. “Walking ability and speed rely on multiple factors and the integration of many systems, cardiovascular and otherwise. We know that pulmonary rehab has multiple benefits and improves these systems, and it’s plausible that change in gait speed may be a surrogate marker for, say, improvement in exercise capacity or health status. But the precise mechanism requires verification.”
Ms. Nolan acknowledged certain limitations of the study, including the fact that contemporaneous measurement of full lung function testing and pulmonary hypertension diagnosis were not available at the time of the study. “Therefore, we were unable to account for [diffusing capacity of the lung for carbon monoxide] and pulmonary hypertension diagnosis,” she said. “Secondly, we were unable to identify the precise cause of death from the national database of harm and care records, but this corroborates previous data which suggest that it’s difficult to reliably discern if a death is IPF- or non-IPF related. Lastly, we know that the benefits of pulmonary rehab experienced by IPF patients tend to wane after 6 months. It would be interesting to compare the short-term improvements in gait speed that we observed to more sustained improvements, to identify whether this impacts prognostability.”
National Institute for Health Research funded the study. Ms. Nolan reported having no financial disclosures.
*Correction, 5/23/18: An earlier version of this article misstated the 4-meter gait speed cutoff point.
SOURCE: Nolan CM et al. ATS 2018, Abstract A2456.
SAN DIEGO – Among patients with idiopathic pulmonary fibrosis (IPF), an improvement in 4-meter gait speed with pulmonary rehabilitation is an independent predictor of all-cause mortality at 1 year, suggest results from a multicenter study presented at an international conference of the American Thoracic Society.
In all, 11% of patients died within 1 year of completing pulmonary rehabilitation.
“Mortality is an attractive endpoint in IPF clinical research but requires large sample sizes and long follow-up duration, making clinical trials expensive and challenging to undertake,” lead study author Claire M. Nolan, MSc, said at the conference.
“Consequently, there is much interest in surrogate endpoints of mortality. In the elderly population, a lot of work has been done on performance measures, in particular the 4-meter gait test. It’s a simple test to do from the assessor’s perspective, because you just need a 4-meter corridor and a stopwatch. From the patient’s perspective, they only have to walk at their usual speed, making it feasible in most settings.”
The study by Ms. Nolan, a National Institute for Health Research fellow, and her associates, involved recruiting 90 IPF patients referred to three outpatient pulmonary rehabilitation programs in London. All patients underwent the following assessments before and after 8 weeks of pulmonary rehabilitation: spirometry; Medical Research Council dyspnea score; anthropometry; 4-meter gait speed; incremental shuttle walk test, and King’s Brief Interstitial Lung Disease questionnaire. Ms. Nolan, a respiratory physiotherapist with the Harefield Pulmonary Rehabilitation and Muscle Research Group, Royal Brompton and Harefield NHS Foundation Trust, Harefield, London, and her associates drew from national databases to obtain data on all-cause mortality 1 year following pulmonary rehabilitation.
“We also identified a cutpoint, so if patients improved their walking speed by 0.009 meters per second or above, that was associated with a longer survival time at 1 year (area under the curve of 0.76, for sensitivity of 69.6% and a specificity of 70%; P less than 0.01),” she said.* “Among patients who achieved that cutpoint or exceeded it, only 5% of them died in the 1-year follow-up period, compared with 23% in the group that didn’t achieve that cutpoint. That’s quite a big difference, but this requires external validation in another population.”
To determine the 4-meter gait speed change cut-off that best discriminated between patients who died and survived, the investigators plotted receiver operating characteristic curves. For validation, they conducted a Kaplan-Meier analysis to assess time to death, with significance assessed via the log-rank test. Finally, they used a multivariate Cox proportional hazards model to characterize the relationship between 4-meter gait speed change and all-cause mortality, adjusting for independent predictors of mortality (age, previous respiratory hospitalizations in the past year, forced vital capacity percent predicted) and baseline 4-meter gait speed.
At baseline, 70% of the 90 patients were male, mean age was 74 years, mean forced vital capacity was 72.8% predicted, and mean Medical Research Council dyspnea score was 3. In addition, mean body mass index was 27.2 kg/m2, mean 4-meter gait speed was 0.92 meters per second, mean incremental shuttle walk test measurement was 271 meters, and mean King’s Brief Interstitial Lung Disease total score was 56.4. Following 8 weeks of pulmonary rehabilitation, the patients’ 4-meter gait speed improved significantly by a mean of 0.15 meters per second (P less than .001). All other variables also improved significantly, with the exception of forced vital capacity.
In an interview, Ms. Nolan characterized the results as “one piece of the puzzle in answering whether 4-meter gait speed is a useful test for clinicians and researchers. It needs to be taken in the context of 4-meter gait speed in other populations as well as with what we’re finding in patients with IPF. We know that this test is reliable, valid, and responsive to treatment. Now we know that it has predictive capacity as well.”
During her presentation, she cited potential reasons why change in gait speed is associated with survival. “Firstly, gait speed has been described as a clinical indicator of multisystem well-being and the ‘sixth vital sign,’ ”she said. “Walking ability and speed rely on multiple factors and the integration of many systems, cardiovascular and otherwise. We know that pulmonary rehab has multiple benefits and improves these systems, and it’s plausible that change in gait speed may be a surrogate marker for, say, improvement in exercise capacity or health status. But the precise mechanism requires verification.”
Ms. Nolan acknowledged certain limitations of the study, including the fact that contemporaneous measurement of full lung function testing and pulmonary hypertension diagnosis were not available at the time of the study. “Therefore, we were unable to account for [diffusing capacity of the lung for carbon monoxide] and pulmonary hypertension diagnosis,” she said. “Secondly, we were unable to identify the precise cause of death from the national database of harm and care records, but this corroborates previous data which suggest that it’s difficult to reliably discern if a death is IPF- or non-IPF related. Lastly, we know that the benefits of pulmonary rehab experienced by IPF patients tend to wane after 6 months. It would be interesting to compare the short-term improvements in gait speed that we observed to more sustained improvements, to identify whether this impacts prognostability.”
National Institute for Health Research funded the study. Ms. Nolan reported having no financial disclosures.
*Correction, 5/23/18: An earlier version of this article misstated the 4-meter gait speed cutoff point.
SOURCE: Nolan CM et al. ATS 2018, Abstract A2456.
SAN DIEGO – Among patients with idiopathic pulmonary fibrosis (IPF), an improvement in 4-meter gait speed with pulmonary rehabilitation is an independent predictor of all-cause mortality at 1 year, suggest results from a multicenter study presented at an international conference of the American Thoracic Society.
In all, 11% of patients died within 1 year of completing pulmonary rehabilitation.
“Mortality is an attractive endpoint in IPF clinical research but requires large sample sizes and long follow-up duration, making clinical trials expensive and challenging to undertake,” lead study author Claire M. Nolan, MSc, said at the conference.
“Consequently, there is much interest in surrogate endpoints of mortality. In the elderly population, a lot of work has been done on performance measures, in particular the 4-meter gait test. It’s a simple test to do from the assessor’s perspective, because you just need a 4-meter corridor and a stopwatch. From the patient’s perspective, they only have to walk at their usual speed, making it feasible in most settings.”
The study by Ms. Nolan, a National Institute for Health Research fellow, and her associates, involved recruiting 90 IPF patients referred to three outpatient pulmonary rehabilitation programs in London. All patients underwent the following assessments before and after 8 weeks of pulmonary rehabilitation: spirometry; Medical Research Council dyspnea score; anthropometry; 4-meter gait speed; incremental shuttle walk test, and King’s Brief Interstitial Lung Disease questionnaire. Ms. Nolan, a respiratory physiotherapist with the Harefield Pulmonary Rehabilitation and Muscle Research Group, Royal Brompton and Harefield NHS Foundation Trust, Harefield, London, and her associates drew from national databases to obtain data on all-cause mortality 1 year following pulmonary rehabilitation.
“We also identified a cutpoint, so if patients improved their walking speed by 0.009 meters per second or above, that was associated with a longer survival time at 1 year (area under the curve of 0.76, for sensitivity of 69.6% and a specificity of 70%; P less than 0.01),” she said.* “Among patients who achieved that cutpoint or exceeded it, only 5% of them died in the 1-year follow-up period, compared with 23% in the group that didn’t achieve that cutpoint. That’s quite a big difference, but this requires external validation in another population.”
To determine the 4-meter gait speed change cut-off that best discriminated between patients who died and survived, the investigators plotted receiver operating characteristic curves. For validation, they conducted a Kaplan-Meier analysis to assess time to death, with significance assessed via the log-rank test. Finally, they used a multivariate Cox proportional hazards model to characterize the relationship between 4-meter gait speed change and all-cause mortality, adjusting for independent predictors of mortality (age, previous respiratory hospitalizations in the past year, forced vital capacity percent predicted) and baseline 4-meter gait speed.
At baseline, 70% of the 90 patients were male, mean age was 74 years, mean forced vital capacity was 72.8% predicted, and mean Medical Research Council dyspnea score was 3. In addition, mean body mass index was 27.2 kg/m2, mean 4-meter gait speed was 0.92 meters per second, mean incremental shuttle walk test measurement was 271 meters, and mean King’s Brief Interstitial Lung Disease total score was 56.4. Following 8 weeks of pulmonary rehabilitation, the patients’ 4-meter gait speed improved significantly by a mean of 0.15 meters per second (P less than .001). All other variables also improved significantly, with the exception of forced vital capacity.
In an interview, Ms. Nolan characterized the results as “one piece of the puzzle in answering whether 4-meter gait speed is a useful test for clinicians and researchers. It needs to be taken in the context of 4-meter gait speed in other populations as well as with what we’re finding in patients with IPF. We know that this test is reliable, valid, and responsive to treatment. Now we know that it has predictive capacity as well.”
During her presentation, she cited potential reasons why change in gait speed is associated with survival. “Firstly, gait speed has been described as a clinical indicator of multisystem well-being and the ‘sixth vital sign,’ ”she said. “Walking ability and speed rely on multiple factors and the integration of many systems, cardiovascular and otherwise. We know that pulmonary rehab has multiple benefits and improves these systems, and it’s plausible that change in gait speed may be a surrogate marker for, say, improvement in exercise capacity or health status. But the precise mechanism requires verification.”
Ms. Nolan acknowledged certain limitations of the study, including the fact that contemporaneous measurement of full lung function testing and pulmonary hypertension diagnosis were not available at the time of the study. “Therefore, we were unable to account for [diffusing capacity of the lung for carbon monoxide] and pulmonary hypertension diagnosis,” she said. “Secondly, we were unable to identify the precise cause of death from the national database of harm and care records, but this corroborates previous data which suggest that it’s difficult to reliably discern if a death is IPF- or non-IPF related. Lastly, we know that the benefits of pulmonary rehab experienced by IPF patients tend to wane after 6 months. It would be interesting to compare the short-term improvements in gait speed that we observed to more sustained improvements, to identify whether this impacts prognostability.”
National Institute for Health Research funded the study. Ms. Nolan reported having no financial disclosures.
*Correction, 5/23/18: An earlier version of this article misstated the 4-meter gait speed cutoff point.
SOURCE: Nolan CM et al. ATS 2018, Abstract A2456.
AT ATS 2018
Key clinical point: Change in 4-meter gait speed following pulmonary rehabilitation is an independent predictor of all-cause mortality at 1 year in patients with IPF.
Major finding: IPF patients who improved their 4-meter walking speed by 0.009 meters per second or more were more likely to be alive 1 year following pulmonary rehabilitation, compared with those who did not reach that cut point (P less than .01).
Study details: A multicenter study of 90 IPF patients who underwent 8 weeks of pulmonary rehabilitation.
Disclosures: The National Institute for Health Research funded the study. Ms. Nolan reported having no financial disclosures.
Source: Nolan, CM et al. ATS 2018, Abstract A2456.
Call for Serious Mental Illness and Substance Use Disorder Manuscripts
Federal Practitioner is inviting VA, DoD, and PHS health care providers and researchers to contribute to a special issue that will be published in October 2018 and will examine series mental health and substance use disorders. Articles that address serious mental illnesses, including schizophrenia, bipolar disorder, major depressive disorder, and alcohol or opioid misuse are especially desired. Articles may include new research, review articles, case studies, quality improvement/quality assurance programs, and patient-centered care best practices.
The full text of all accepted Federal Practitioner articles are now included in the PubMed Central database and are part of any PubMed search result.
Interested authors can submit articles at http://www.editorialmanager.com/fedprac or submit a brief 2 to 3 sentence abstract to fedprac@mdedge.com by July 15, 2018. The updated and complete submission guidelines, including details about the style and format, can be found here:
http://www.mdedge.com/fedprac/page/submission-guidelines
Federal Practitioner uses Editorial Manager, a web-based manuscript submission and review system. All manuscripts must be submitted through this system.
All manuscripts submitted to Federal Practitioner for both special and regular issues will be subject to peer review. Peer reviews are conducted in a double-blind fashion, and the reviewers are asked to comment on the manuscript’s importance, accuracy, relevance, clarity, timeliness, balance, and reference citation. Final decisions on all submitted manuscripts are made by the Editor-in-Chief (or, in the event of a potential conflict of interest, a designated surrogate from the journal’s Editorial Advisory Association).
Federal Practitioner is inviting VA, DoD, and PHS health care providers and researchers to contribute to a special issue that will be published in October 2018 and will examine series mental health and substance use disorders. Articles that address serious mental illnesses, including schizophrenia, bipolar disorder, major depressive disorder, and alcohol or opioid misuse are especially desired. Articles may include new research, review articles, case studies, quality improvement/quality assurance programs, and patient-centered care best practices.
The full text of all accepted Federal Practitioner articles are now included in the PubMed Central database and are part of any PubMed search result.
Interested authors can submit articles at http://www.editorialmanager.com/fedprac or submit a brief 2 to 3 sentence abstract to fedprac@mdedge.com by July 15, 2018. The updated and complete submission guidelines, including details about the style and format, can be found here:
http://www.mdedge.com/fedprac/page/submission-guidelines
Federal Practitioner uses Editorial Manager, a web-based manuscript submission and review system. All manuscripts must be submitted through this system.
All manuscripts submitted to Federal Practitioner for both special and regular issues will be subject to peer review. Peer reviews are conducted in a double-blind fashion, and the reviewers are asked to comment on the manuscript’s importance, accuracy, relevance, clarity, timeliness, balance, and reference citation. Final decisions on all submitted manuscripts are made by the Editor-in-Chief (or, in the event of a potential conflict of interest, a designated surrogate from the journal’s Editorial Advisory Association).
Federal Practitioner is inviting VA, DoD, and PHS health care providers and researchers to contribute to a special issue that will be published in October 2018 and will examine series mental health and substance use disorders. Articles that address serious mental illnesses, including schizophrenia, bipolar disorder, major depressive disorder, and alcohol or opioid misuse are especially desired. Articles may include new research, review articles, case studies, quality improvement/quality assurance programs, and patient-centered care best practices.
The full text of all accepted Federal Practitioner articles are now included in the PubMed Central database and are part of any PubMed search result.
Interested authors can submit articles at http://www.editorialmanager.com/fedprac or submit a brief 2 to 3 sentence abstract to fedprac@mdedge.com by July 15, 2018. The updated and complete submission guidelines, including details about the style and format, can be found here:
http://www.mdedge.com/fedprac/page/submission-guidelines
Federal Practitioner uses Editorial Manager, a web-based manuscript submission and review system. All manuscripts must be submitted through this system.
All manuscripts submitted to Federal Practitioner for both special and regular issues will be subject to peer review. Peer reviews are conducted in a double-blind fashion, and the reviewers are asked to comment on the manuscript’s importance, accuracy, relevance, clarity, timeliness, balance, and reference citation. Final decisions on all submitted manuscripts are made by the Editor-in-Chief (or, in the event of a potential conflict of interest, a designated surrogate from the journal’s Editorial Advisory Association).