Hematology Nursing

Lab mouse

Results of a new study contradict previous research suggesting mice do not make suitable models for human inflammatory conditions.

The original study, published in PNAS in February 2013, indicated that genomic responses to different acute inflammatory stressors—trauma, burns, sepsis, and infection—are highly similar in humans but poorly reproduced in corresponding mouse models.

The new study, published in PNAS yesterday, suggests that is not the case.

The original study was conducted by Junhee Seok, PhD, of Northwestern University, and his colleagues. It garnered a lot of attention from the scientific community and the general public, reigniting the debate over mouse models’ suitability for medical research.

Tsuyoshi Miyakawa, PhD, of Fujita Health University in Japan, was among those who argued that mice are suitable models, and Dr Seok’s findings were likely incorrect.

So Dr Miyakawa and his colleague, Keizo Takao, PhD, of the National Institute for Physiological Sciences in Japan, reanalyzed the data from Dr Seok’s study using the bioinformatics tool NextBio. 

Dr Seok’s group had compared the expression levels of genes that were altered in a particular human condition between humans and mice.

A comparison of the genomic response between humans and mice, including those genes altered in one species but not in another, obscures the correlation between homologous genes of humans and mice to nearly 0, as the team showed.

The group’s comparison of the gene expression patterns between human burn victims and mouse models of burns, trauma, sepsis, and infection revealed a Pearson’s correlation coefficient (R) that ranged from 0.14 to 0.28. And the percentage of genes whose expression changed in the same direction was 55% to 61%.

In the new analysis based on the same data, Drs Miyakawa and Takao found the R values ranged from 0.36 to 0.59. And 77% to 93% of the genes changed in the same directions between the human condition and the mouse models.

Non-parametric ranking analysis using NextBio showed the pattern of the gene expression changes in mouse models was highly similar to that in human burn conditions—a significant correlation (P = 6.5 x 10^-11 to 1.2 x 10^-35).

Drs Miyakawa and Takao noted that many molecular pathways are commonly dysregulated in human diseases and mouse models. And focusing on the commonalities between human diseases and mouse models will allow us to derive useful information for studying the pathophysiology and pathogenesis of human diseases, as well as aid treatment development.

Lab mouse

Results of a new study contradict previous research suggesting mice do not make suitable models for human inflammatory conditions.

The original study, published in PNAS in February 2013, indicated that genomic responses to different acute inflammatory stressors—trauma, burns, sepsis, and infection—are highly similar in humans but poorly reproduced in corresponding mouse models.

The new study, published in PNAS yesterday, suggests that is not the case.

The original study was conducted by Junhee Seok, PhD, of Northwestern University, and his colleagues. It garnered a lot of attention from the scientific community and the general public, reigniting the debate over mouse models’ suitability for medical research.

Tsuyoshi Miyakawa, PhD, of Fujita Health University in Japan, was among those who argued that mice are suitable models, and Dr Seok’s findings were likely incorrect.

So Dr Miyakawa and his colleague, Keizo Takao, PhD, of the National Institute for Physiological Sciences in Japan, reanalyzed the data from Dr Seok’s study using the bioinformatics tool NextBio. 

Dr Seok’s group had compared the expression levels of genes that were altered in a particular human condition between humans and mice.

A comparison of the genomic response between humans and mice, including those genes altered in one species but not in another, obscures the correlation between homologous genes of humans and mice to nearly 0, as the team showed.

The group’s comparison of the gene expression patterns between human burn victims and mouse models of burns, trauma, sepsis, and infection revealed a Pearson’s correlation coefficient (R) that ranged from 0.14 to 0.28. And the percentage of genes whose expression changed in the same direction was 55% to 61%.

In the new analysis based on the same data, Drs Miyakawa and Takao found the R values ranged from 0.36 to 0.59. And 77% to 93% of the genes changed in the same directions between the human condition and the mouse models.

Non-parametric ranking analysis using NextBio showed the pattern of the gene expression changes in mouse models was highly similar to that in human burn conditions—a significant correlation (P = 6.5 x 10^-11 to 1.2 x 10^-35).

Drs Miyakawa and Takao noted that many molecular pathways are commonly dysregulated in human diseases and mouse models. And focusing on the commonalities between human diseases and mouse models will allow us to derive useful information for studying the pathophysiology and pathogenesis of human diseases, as well as aid treatment development.

Lab mouse

Results of a new study contradict previous research suggesting mice do not make suitable models for human inflammatory conditions.

The original study, published in PNAS in February 2013, indicated that genomic responses to different acute inflammatory stressors—trauma, burns, sepsis, and infection—are highly similar in humans but poorly reproduced in corresponding mouse models.

The new study, published in PNAS yesterday, suggests that is not the case.

The original study was conducted by Junhee Seok, PhD, of Northwestern University, and his colleagues. It garnered a lot of attention from the scientific community and the general public, reigniting the debate over mouse models’ suitability for medical research.

Tsuyoshi Miyakawa, PhD, of Fujita Health University in Japan, was among those who argued that mice are suitable models, and Dr Seok’s findings were likely incorrect.

So Dr Miyakawa and his colleague, Keizo Takao, PhD, of the National Institute for Physiological Sciences in Japan, reanalyzed the data from Dr Seok’s study using the bioinformatics tool NextBio. 

Dr Seok’s group had compared the expression levels of genes that were altered in a particular human condition between humans and mice.

A comparison of the genomic response between humans and mice, including those genes altered in one species but not in another, obscures the correlation between homologous genes of humans and mice to nearly 0, as the team showed.

The group’s comparison of the gene expression patterns between human burn victims and mouse models of burns, trauma, sepsis, and infection revealed a Pearson’s correlation coefficient (R) that ranged from 0.14 to 0.28. And the percentage of genes whose expression changed in the same direction was 55% to 61%.

In the new analysis based on the same data, Drs Miyakawa and Takao found the R values ranged from 0.36 to 0.59. And 77% to 93% of the genes changed in the same directions between the human condition and the mouse models.

Non-parametric ranking analysis using NextBio showed the pattern of the gene expression changes in mouse models was highly similar to that in human burn conditions—a significant correlation (P = 6.5 x 10^-11 to 1.2 x 10^-35).

Drs Miyakawa and Takao noted that many molecular pathways are commonly dysregulated in human diseases and mouse models. And focusing on the commonalities between human diseases and mouse models will allow us to derive useful information for studying the pathophysiology and pathogenesis of human diseases, as well as aid treatment development.

Doctor consults with cancer

patient and her father

Credit: Rhoda Baer

Following a healthy lifestyle can decrease the risk of metabolic syndrome in childhood cancer survivors, according to a study published in Cancer.

Unfortunately, only about a quarter of the survivors studied actually practiced healthy lifestyle habits, such as engaging in moderate physical activity; eating the recommended daily serving of fruits, vegetables, and complex carbohydrates; and consuming red meat, alcohol, and sodium in moderation.

Childhood cancer survivors are known to have an increased risk of developing metabolic syndrome.

The syndrome is actually a number of conditions—high blood pressure, increased body fat, and abnormal cholesterol and glucose levels—that, when they occur together, increase a person’s risk of heart disease, stroke, and diabetes.

Kirsten Ness, PhD, of St Jude Children’s Research Hospital in Memphis, Tennessee, and her colleagues wanted to determine if lifestyle habits might affect the risk of metabolic syndrome among childhood cancer survivors.

So the team analyzed 1598 survivors who were cancer-free for at least 10 years. They had a median age of 32.7 years (range, 18.9 to 60).

The analysis showed that failure to follow healthy lifestyle guidelines roughly doubled the survivors’ risk of developing metabolic syndrome. Women had a 2.4-times greater risk, and men had a 2.2-times greater risk of the syndrome if they did not follow the guidelines.

Metabolic syndrome was present in 31.8% of the participants—32.5% of males and 31% of females.

The researchers considered a subject to have metabolic syndrome if he had or received treatment for 3 or more of the following:

• Abdominal obesity (waist circumference of > 102 cm in males and > 88 cm in females)
• Triglycerides ≥ 150 mg/dL
• High-density lipoprotein cholesterol (< 40 mg/dL in males and < 50 mg/dL in females)
• Hypertension (systolic pressure ≥ 130 mm Hg or diastolic pressure ≥ 85 mm Hg)
• Fasting plasma glucose ≥ 100 mg/dL.

Questionnaires and tests helped the researchers assess whether participants followed healthy lifestyle recommendations issued by the World Cancer Research Fund and American Institute for Cancer Research.

The recommendations include:

• Having a body mass index of 25 or lower
• Engaging in moderate physical activity for 150 minutes each week
• Eating 5 or more servings of fruits and vegetables each day
• Consuming 400 g or more of complex carbohydrates daily
• Eating less than 80 g of red meat each day
• Consuming less than 2400 mg of sodium each day
• Low daily alcohol consumption (less than 14 g for females and less than 28 g for males).

Subjects who met at least 4 of these 7 criteria were classified as following the guidelines. And 27% of the participants—25.2% of males and 28.8% of females—were classified as such.

“These findings are important because they indicate that adults who were treated for cancer as children have the opportunity to influence their own health outcomes,” Dr Ness said.

“[A]dopting a lifestyle that includes maintaining a healthy body weight, regular physical activity, and a diet that includes fruits and vegetables and that limits refined sugars, excessive alcohol, red meat, and salt has potential to prevent development of metabolic syndrome.”

Doctor consults with cancer

patient and her father

Credit: Rhoda Baer

Following a healthy lifestyle can decrease the risk of metabolic syndrome in childhood cancer survivors, according to a study published in Cancer.

Unfortunately, only about a quarter of the survivors studied actually practiced healthy lifestyle habits, such as engaging in moderate physical activity; eating the recommended daily serving of fruits, vegetables, and complex carbohydrates; and consuming red meat, alcohol, and sodium in moderation.

Childhood cancer survivors are known to have an increased risk of developing metabolic syndrome.

The syndrome is actually a number of conditions—high blood pressure, increased body fat, and abnormal cholesterol and glucose levels—that, when they occur together, increase a person’s risk of heart disease, stroke, and diabetes.

Kirsten Ness, PhD, of St Jude Children’s Research Hospital in Memphis, Tennessee, and her colleagues wanted to determine if lifestyle habits might affect the risk of metabolic syndrome among childhood cancer survivors.

So the team analyzed 1598 survivors who were cancer-free for at least 10 years. They had a median age of 32.7 years (range, 18.9 to 60).

The analysis showed that failure to follow healthy lifestyle guidelines roughly doubled the survivors’ risk of developing metabolic syndrome. Women had a 2.4-times greater risk, and men had a 2.2-times greater risk of the syndrome if they did not follow the guidelines.

Metabolic syndrome was present in 31.8% of the participants—32.5% of males and 31% of females.

The researchers considered a subject to have metabolic syndrome if he had or received treatment for 3 or more of the following:

• Abdominal obesity (waist circumference of > 102 cm in males and > 88 cm in females)
• Triglycerides ≥ 150 mg/dL
• High-density lipoprotein cholesterol (< 40 mg/dL in males and < 50 mg/dL in females)
• Hypertension (systolic pressure ≥ 130 mm Hg or diastolic pressure ≥ 85 mm Hg)
• Fasting plasma glucose ≥ 100 mg/dL.

Questionnaires and tests helped the researchers assess whether participants followed healthy lifestyle recommendations issued by the World Cancer Research Fund and American Institute for Cancer Research.

The recommendations include:

• Having a body mass index of 25 or lower
• Engaging in moderate physical activity for 150 minutes each week
• Eating 5 or more servings of fruits and vegetables each day
• Consuming 400 g or more of complex carbohydrates daily
• Eating less than 80 g of red meat each day
• Consuming less than 2400 mg of sodium each day
• Low daily alcohol consumption (less than 14 g for females and less than 28 g for males).

Subjects who met at least 4 of these 7 criteria were classified as following the guidelines. And 27% of the participants—25.2% of males and 28.8% of females—were classified as such.

“These findings are important because they indicate that adults who were treated for cancer as children have the opportunity to influence their own health outcomes,” Dr Ness said.

“[A]dopting a lifestyle that includes maintaining a healthy body weight, regular physical activity, and a diet that includes fruits and vegetables and that limits refined sugars, excessive alcohol, red meat, and salt has potential to prevent development of metabolic syndrome.”

Doctor consults with cancer

patient and her father

Credit: Rhoda Baer

Following a healthy lifestyle can decrease the risk of metabolic syndrome in childhood cancer survivors, according to a study published in Cancer.

Unfortunately, only about a quarter of the survivors studied actually practiced healthy lifestyle habits, such as engaging in moderate physical activity; eating the recommended daily serving of fruits, vegetables, and complex carbohydrates; and consuming red meat, alcohol, and sodium in moderation.

Childhood cancer survivors are known to have an increased risk of developing metabolic syndrome.

The syndrome is actually a number of conditions—high blood pressure, increased body fat, and abnormal cholesterol and glucose levels—that, when they occur together, increase a person’s risk of heart disease, stroke, and diabetes.

Kirsten Ness, PhD, of St Jude Children’s Research Hospital in Memphis, Tennessee, and her colleagues wanted to determine if lifestyle habits might affect the risk of metabolic syndrome among childhood cancer survivors.

So the team analyzed 1598 survivors who were cancer-free for at least 10 years. They had a median age of 32.7 years (range, 18.9 to 60).

The analysis showed that failure to follow healthy lifestyle guidelines roughly doubled the survivors’ risk of developing metabolic syndrome. Women had a 2.4-times greater risk, and men had a 2.2-times greater risk of the syndrome if they did not follow the guidelines.

Metabolic syndrome was present in 31.8% of the participants—32.5% of males and 31% of females.

The researchers considered a subject to have metabolic syndrome if he had or received treatment for 3 or more of the following:

• Abdominal obesity (waist circumference of > 102 cm in males and > 88 cm in females)
• Triglycerides ≥ 150 mg/dL
• High-density lipoprotein cholesterol (< 40 mg/dL in males and < 50 mg/dL in females)
• Hypertension (systolic pressure ≥ 130 mm Hg or diastolic pressure ≥ 85 mm Hg)
• Fasting plasma glucose ≥ 100 mg/dL.

Questionnaires and tests helped the researchers assess whether participants followed healthy lifestyle recommendations issued by the World Cancer Research Fund and American Institute for Cancer Research.

The recommendations include:

• Having a body mass index of 25 or lower
• Engaging in moderate physical activity for 150 minutes each week
• Eating 5 or more servings of fruits and vegetables each day
• Consuming 400 g or more of complex carbohydrates daily
• Eating less than 80 g of red meat each day
• Consuming less than 2400 mg of sodium each day
• Low daily alcohol consumption (less than 14 g for females and less than 28 g for males).

Subjects who met at least 4 of these 7 criteria were classified as following the guidelines. And 27% of the participants—25.2% of males and 28.8% of females—were classified as such.

“These findings are important because they indicate that adults who were treated for cancer as children have the opportunity to influence their own health outcomes,” Dr Ness said.

“[A]dopting a lifestyle that includes maintaining a healthy body weight, regular physical activity, and a diet that includes fruits and vegetables and that limits refined sugars, excessive alcohol, red meat, and salt has potential to prevent development of metabolic syndrome.”

Nurses administering

chemo to a cancer patient

Credit: Rhoda Baer

The nursing workforce in the US has grown substantially in recent years, and this is only partly due to an increase in nursing graduates, according to a new study.

The research revealed that registered nurses (RNs) are putting off retirement for longer than they have in the past.

From 1991 to 2012, 24% of RNs who were working at age 50 remained working as late as age 69. From 1969 to 1990, however, only 9% of nurses were still working at age 69.

These findings appear in Health Affairs.

“We estimate this trend accounts for about a quarter of an unexpected surge in the supply of registered nurses that the nation has experienced in recent years,” said study author David Auerbach, PhD, of RAND Corporation in Boston. “This may provide advantages to parts of the US healthcare system.”

The researchers noted that the RN workforce has surpassed forecasts from a decade ago, growing to 2.7 million in 2012 instead of peaking at 2.2 million as predicted. While much of the difference is the result of a surge in new nursing graduates, the size of the workforce is particularly sensitive to changes in retirement age.

Dr Auerbach and his colleagues uncovered the trend of delaying retirement by analyzing data from the Current Population Survey and the American Community Survey.

The team included all respondents aged 23 to 69 who reported being employed as an RN during the week of the relevant survey from 1969 to 2012. There were 70,724 RNs who responded to the Current Population Survey and 307,187 who responded to the American Community Survey.

The researchers found that, from 1969 to 1990, for a given number of RNs working at age 50, 47% were still working at age 62. From 1991 to 2012, 74% of RNs were working at age 62.

The trend of RNs delaying retirement, which largely predates the recent recession, extended nursing careers by 2.5 years after age 50 and increased the 2012 RN workforce by 136,000 people, according to the researchers.

The team said the reasons older RNs are working longer is unclear, but it is likely part of an overall trend that has seen more Americans—particularly women—stay in the workforce longer because of lengthening life expectancy and the satisfaction they derive from employment.

Nurses administering

chemo to a cancer patient

Credit: Rhoda Baer

The nursing workforce in the US has grown substantially in recent years, and this is only partly due to an increase in nursing graduates, according to a new study.

The research revealed that registered nurses (RNs) are putting off retirement for longer than they have in the past.

From 1991 to 2012, 24% of RNs who were working at age 50 remained working as late as age 69. From 1969 to 1990, however, only 9% of nurses were still working at age 69.

These findings appear in Health Affairs.

“We estimate this trend accounts for about a quarter of an unexpected surge in the supply of registered nurses that the nation has experienced in recent years,” said study author David Auerbach, PhD, of RAND Corporation in Boston. “This may provide advantages to parts of the US healthcare system.”

The researchers noted that the RN workforce has surpassed forecasts from a decade ago, growing to 2.7 million in 2012 instead of peaking at 2.2 million as predicted. While much of the difference is the result of a surge in new nursing graduates, the size of the workforce is particularly sensitive to changes in retirement age.

Dr Auerbach and his colleagues uncovered the trend of delaying retirement by analyzing data from the Current Population Survey and the American Community Survey.

The team included all respondents aged 23 to 69 who reported being employed as an RN during the week of the relevant survey from 1969 to 2012. There were 70,724 RNs who responded to the Current Population Survey and 307,187 who responded to the American Community Survey.

The researchers found that, from 1969 to 1990, for a given number of RNs working at age 50, 47% were still working at age 62. From 1991 to 2012, 74% of RNs were working at age 62.

The trend of RNs delaying retirement, which largely predates the recent recession, extended nursing careers by 2.5 years after age 50 and increased the 2012 RN workforce by 136,000 people, according to the researchers.

The team said the reasons older RNs are working longer is unclear, but it is likely part of an overall trend that has seen more Americans—particularly women—stay in the workforce longer because of lengthening life expectancy and the satisfaction they derive from employment.

Nurses administering

chemo to a cancer patient

Credit: Rhoda Baer

The nursing workforce in the US has grown substantially in recent years, and this is only partly due to an increase in nursing graduates, according to a new study.

The research revealed that registered nurses (RNs) are putting off retirement for longer than they have in the past.

From 1991 to 2012, 24% of RNs who were working at age 50 remained working as late as age 69. From 1969 to 1990, however, only 9% of nurses were still working at age 69.

These findings appear in Health Affairs.

“We estimate this trend accounts for about a quarter of an unexpected surge in the supply of registered nurses that the nation has experienced in recent years,” said study author David Auerbach, PhD, of RAND Corporation in Boston. “This may provide advantages to parts of the US healthcare system.”

The researchers noted that the RN workforce has surpassed forecasts from a decade ago, growing to 2.7 million in 2012 instead of peaking at 2.2 million as predicted. While much of the difference is the result of a surge in new nursing graduates, the size of the workforce is particularly sensitive to changes in retirement age.

Dr Auerbach and his colleagues uncovered the trend of delaying retirement by analyzing data from the Current Population Survey and the American Community Survey.

The team included all respondents aged 23 to 69 who reported being employed as an RN during the week of the relevant survey from 1969 to 2012. There were 70,724 RNs who responded to the Current Population Survey and 307,187 who responded to the American Community Survey.

The researchers found that, from 1969 to 1990, for a given number of RNs working at age 50, 47% were still working at age 62. From 1991 to 2012, 74% of RNs were working at age 62.

The trend of RNs delaying retirement, which largely predates the recent recession, extended nursing careers by 2.5 years after age 50 and increased the 2012 RN workforce by 136,000 people, according to the researchers.

The team said the reasons older RNs are working longer is unclear, but it is likely part of an overall trend that has seen more Americans—particularly women—stay in the workforce longer because of lengthening life expectancy and the satisfaction they derive from employment.

Blood samples

Credit: Graham Colm

An immune marker may help predict which child trauma patients are likely to develop a hospital-acquired infection, and it may also provide new insight into immune response following transfusion.

In a small study, blood samples from critically ill children showed decreased production of TNF-alpha, a cytokine that’s part of the first line of defense in the innate immune system, when compared to samples from healthy control children.

In addition, TNF-alpha production was lower among children who received transfusions with older blood, compared to children who received fresher blood.

Mark W. Hall, MD, of Nationwide Children’s Hospital in Columbus, Ohio, and his colleagues reported these findings in Shock.

The researchers had collected blood samples from 21 healthy children and 76 critically injured children aged 18 years or younger. The team then exposed each sample to lipopolysaccharide (LPS), a known stimulant of the immune response. When healthy cells are exposed to LPS, it prompts the production of TNF-alpha.

When they analyzed the immune response, the researchers found that blood samples from the healthy children responded normally to LPS, producing high levels of TNF-alpha.

Samples from the patients with critical injuries all showed at least a moderate decrease in the production of TNF-alpha. But the children who went on to develop an infection showed a much more severe and persistent drop in TNF-alpha following injury.

While the findings strongly suggest that infection risk is associated with immune system function after critical injury, they don’t explain what’s causing the malfunction. Dr Hall’s team is investigating that question now.

Transfusion implications

The research also highlighted another issue that may affect the immune response in critical illness. The team found that patients who received a transfusion of blood stored for more than 2 weeks had a lower level of TNF-alpha production than kids whose transfused blood was less than 2 weeks old, regardless of the severity of their original injury.

This supports a study published by Dr Hall and his colleagues in 2012 in Transfusion. The study showed the same immunosuppressive effect in a human cell culture model.

Dr Hall plans to look into this further through his work with a multi-institutional effort called The Pediatric Critical Care Blood Research Network (BloodNet). The group is studying, among other things, what impact blood transfusions have on immune function.

“There’s a whole line of research in which we’re involved that is dedicated to understanding the effects of transfusion in critical illness,” he said. “It’s not clear yet if blood transfusions are immunosuppressive, but our work so far suggests that blood becomes more immunosuppressive the longer it sits on the shelf.”

Reversing immunosuppression

Yet another element to the study involves reversing the immunosuppression that follows critical injury or illness. The researchers took 3 blood samples in which TNF-alpha production was decreased and cultured them with GM-CSF.

Once treated, the cells began to produce normal levels of TNF-alpha—an indication that the immunosuppression had been reversed.

Dr Hall is now leading a phase 4 clinical trial of GM-CSF to reverse immunosuppression in critically injured patients aged 1 to 21 years old.

Although findings from that project won’t be ready for another year or so, the results in the Shock article seem to offer yet another weapon in physicians’ arsenal when caring for critically ill and injured children, Dr Hall said.

“We have certainly made headway in reducing preventable infections through programs such as our own Zero Hero initiative,” he noted.

“But what this paper suggests is that it’s also important to consider the patient’s immune system and how well they are able to fight off infection. We believe that critical illness- and injury-related immune suppression may be reversible with beneficial effects on clinical outcomes.”

Blood samples

Credit: Graham Colm

An immune marker may help predict which child trauma patients are likely to develop a hospital-acquired infection, and it may also provide new insight into immune response following transfusion.

In a small study, blood samples from critically ill children showed decreased production of TNF-alpha, a cytokine that’s part of the first line of defense in the innate immune system, when compared to samples from healthy control children.

In addition, TNF-alpha production was lower among children who received transfusions with older blood, compared to children who received fresher blood.

Mark W. Hall, MD, of Nationwide Children’s Hospital in Columbus, Ohio, and his colleagues reported these findings in Shock.

The researchers had collected blood samples from 21 healthy children and 76 critically injured children aged 18 years or younger. The team then exposed each sample to lipopolysaccharide (LPS), a known stimulant of the immune response. When healthy cells are exposed to LPS, it prompts the production of TNF-alpha.

When they analyzed the immune response, the researchers found that blood samples from the healthy children responded normally to LPS, producing high levels of TNF-alpha.

Samples from the patients with critical injuries all showed at least a moderate decrease in the production of TNF-alpha. But the children who went on to develop an infection showed a much more severe and persistent drop in TNF-alpha following injury.

While the findings strongly suggest that infection risk is associated with immune system function after critical injury, they don’t explain what’s causing the malfunction. Dr Hall’s team is investigating that question now.

Transfusion implications

The research also highlighted another issue that may affect the immune response in critical illness. The team found that patients who received a transfusion of blood stored for more than 2 weeks had a lower level of TNF-alpha production than kids whose transfused blood was less than 2 weeks old, regardless of the severity of their original injury.

This supports a study published by Dr Hall and his colleagues in 2012 in Transfusion. The study showed the same immunosuppressive effect in a human cell culture model.

Dr Hall plans to look into this further through his work with a multi-institutional effort called The Pediatric Critical Care Blood Research Network (BloodNet). The group is studying, among other things, what impact blood transfusions have on immune function.

“There’s a whole line of research in which we’re involved that is dedicated to understanding the effects of transfusion in critical illness,” he said. “It’s not clear yet if blood transfusions are immunosuppressive, but our work so far suggests that blood becomes more immunosuppressive the longer it sits on the shelf.”

Reversing immunosuppression

Yet another element to the study involves reversing the immunosuppression that follows critical injury or illness. The researchers took 3 blood samples in which TNF-alpha production was decreased and cultured them with GM-CSF.

Once treated, the cells began to produce normal levels of TNF-alpha—an indication that the immunosuppression had been reversed.

Dr Hall is now leading a phase 4 clinical trial of GM-CSF to reverse immunosuppression in critically injured patients aged 1 to 21 years old.

Although findings from that project won’t be ready for another year or so, the results in the Shock article seem to offer yet another weapon in physicians’ arsenal when caring for critically ill and injured children, Dr Hall said.

“We have certainly made headway in reducing preventable infections through programs such as our own Zero Hero initiative,” he noted.

“But what this paper suggests is that it’s also important to consider the patient’s immune system and how well they are able to fight off infection. We believe that critical illness- and injury-related immune suppression may be reversible with beneficial effects on clinical outcomes.”

Blood samples

Credit: Graham Colm

An immune marker may help predict which child trauma patients are likely to develop a hospital-acquired infection, and it may also provide new insight into immune response following transfusion.

In a small study, blood samples from critically ill children showed decreased production of TNF-alpha, a cytokine that’s part of the first line of defense in the innate immune system, when compared to samples from healthy control children.

In addition, TNF-alpha production was lower among children who received transfusions with older blood, compared to children who received fresher blood.

Mark W. Hall, MD, of Nationwide Children’s Hospital in Columbus, Ohio, and his colleagues reported these findings in Shock.

The researchers had collected blood samples from 21 healthy children and 76 critically injured children aged 18 years or younger. The team then exposed each sample to lipopolysaccharide (LPS), a known stimulant of the immune response. When healthy cells are exposed to LPS, it prompts the production of TNF-alpha.

When they analyzed the immune response, the researchers found that blood samples from the healthy children responded normally to LPS, producing high levels of TNF-alpha.

Samples from the patients with critical injuries all showed at least a moderate decrease in the production of TNF-alpha. But the children who went on to develop an infection showed a much more severe and persistent drop in TNF-alpha following injury.

While the findings strongly suggest that infection risk is associated with immune system function after critical injury, they don’t explain what’s causing the malfunction. Dr Hall’s team is investigating that question now.

Transfusion implications

The research also highlighted another issue that may affect the immune response in critical illness. The team found that patients who received a transfusion of blood stored for more than 2 weeks had a lower level of TNF-alpha production than kids whose transfused blood was less than 2 weeks old, regardless of the severity of their original injury.

This supports a study published by Dr Hall and his colleagues in 2012 in Transfusion. The study showed the same immunosuppressive effect in a human cell culture model.

Dr Hall plans to look into this further through his work with a multi-institutional effort called The Pediatric Critical Care Blood Research Network (BloodNet). The group is studying, among other things, what impact blood transfusions have on immune function.

“There’s a whole line of research in which we’re involved that is dedicated to understanding the effects of transfusion in critical illness,” he said. “It’s not clear yet if blood transfusions are immunosuppressive, but our work so far suggests that blood becomes more immunosuppressive the longer it sits on the shelf.”

Reversing immunosuppression

Yet another element to the study involves reversing the immunosuppression that follows critical injury or illness. The researchers took 3 blood samples in which TNF-alpha production was decreased and cultured them with GM-CSF.

Once treated, the cells began to produce normal levels of TNF-alpha—an indication that the immunosuppression had been reversed.

Dr Hall is now leading a phase 4 clinical trial of GM-CSF to reverse immunosuppression in critically injured patients aged 1 to 21 years old.

Although findings from that project won’t be ready for another year or so, the results in the Shock article seem to offer yet another weapon in physicians’ arsenal when caring for critically ill and injured children, Dr Hall said.

“We have certainly made headway in reducing preventable infections through programs such as our own Zero Hero initiative,” he noted.

“But what this paper suggests is that it’s also important to consider the patient’s immune system and how well they are able to fight off infection. We believe that critical illness- and injury-related immune suppression may be reversible with beneficial effects on clinical outcomes.”

Hydrogels

Credit: Kathy Atkinson

Researchers have devised a novel way to deliver chemotherapy drugs “on demand,” according to a paper published in Proceedings of the National Academy of Sciences.

The team loaded a biocompatible hydrogel with a chemotherapy drug and used ultrasound to trigger the gel to release the drug.

Like many other injectable gels, this one gradually releases a low level of the drug by diffusion over time. But the new hydrogel differs from others in a key way.

Researchers previously applied ultrasound to gels to temporarily increase doses of drug, but that approach was a one-shot deal, as the ultrasound was used to destroy those gels.

In the current study, the researchers used ultrasound to temporarily disrupt the gel so that it released short, high-dose bursts of the drug. But when they stopped the ultrasound, the hydrogels self-healed.

By closing back up, they were ready to go for the next “on demand” drug burst, providing a way to administer drugs with a greater level of control than was possible before.

The researchers also demonstrated in lab cultures and in mouse models of breast cancer that the pulsed, ultrasound-triggered hydrogel approach to drug delivery was more effective at stopping the growth of tumor cells than traditional, sustained-release drug therapy.

“Our approach counters the whole idea of sustained drug release and offers a double whammy,” said study author David J. Mooney, PhD, of the Harvard School of Engineering and Applied Sciences in Boston.

“We have shown that we can use the hydrogels repeatedly and turn the drug pulses on and off at will, and that the drug bursts in concert with the baseline low-level drug delivery seems to be particularly effective in killing cancer cells.”

Self-healing hydrogel

Key to the researchers’ success in designing a hydrogel that self-heals was choosing the right kind of hydrogel with the right kind of drug and applying the right intensity of ultrasound.

“We were able to trigger our system with a level of ultrasound that was much lower than high-intensity focused ultrasound that is used clinically to heat and destroy tumors,” said study author Cathal Kearney, PhD, of the Royal College of Surgeons in Ireland. “The careful selection of materials and properties make it a reversible process.”

The team carried out the majority of their work for this study with a gel made out of alginate, a natural polysaccharide from algae that is held together with calcium ions.

In a series of tests, they found that, with the right level of ultrasound, the bonds break up and enable the gel to release its drug cargo. But as long as the gel is in the presence of more calcium, the bonds reform and the gel self-heals.

Drug testing

Once the researchers knew the gel would self-heal, they tested out a drug they suspected it would hold well: the chemotherapy drug mitoxantrone.

Sure enough, the ultrasound triggered the gel to release the blue-colored drug, as indicated by the newly blue color of the surrounding medium. Just a single ultrasound dose was effective, and the gel reformed after it was disrupted, making multiple cycles possible.

Next, the team tested the treatment in mouse models of breast cancer. They injected the drug-laden gel close to the tumors.

Over the course of 6 months, the mice that received a low-level, sustained release of the drug with a daily concentrated pulse of ultrasound (2.5 minutes) fared significantly better than mice treated the same but without ultrasound.

In contrast to controls, the tumors in the ultrasound-treated mice did not grow substantially. And the mice survived for an additional 80 days.

Potential applications

The researchers believe their technique could help improve cancer treatment and other therapies requiring drugs to be delivered at the right place and the right time—from post-surgery pain medications to protein-based drugs that require daily injections.

It requires an initial injection of the hydrogel, but the approach could be a much less traumatic, minimally invasive, and more effective method of drug delivery than current methods, Dr Mooney said.

The researchers also found their hydrogel can release cargo other than drugs, including proteins and condensed plasmid DNA. This lays the groundwork for using these hydrogels for tissue regeneration and gene therapy.

Dr Mooney said he and his colleagues plan to explore these potential applications, as well as the possibility of unleashing 2 different drugs independently from the same hydrogel.

Hydrogels

Credit: Kathy Atkinson

Researchers have devised a novel way to deliver chemotherapy drugs “on demand,” according to a paper published in Proceedings of the National Academy of Sciences.

The team loaded a biocompatible hydrogel with a chemotherapy drug and used ultrasound to trigger the gel to release the drug.

Like many other injectable gels, this one gradually releases a low level of the drug by diffusion over time. But the new hydrogel differs from others in a key way.

Researchers previously applied ultrasound to gels to temporarily increase doses of drug, but that approach was a one-shot deal, as the ultrasound was used to destroy those gels.

In the current study, the researchers used ultrasound to temporarily disrupt the gel so that it released short, high-dose bursts of the drug. But when they stopped the ultrasound, the hydrogels self-healed.

By closing back up, they were ready to go for the next “on demand” drug burst, providing a way to administer drugs with a greater level of control than was possible before.

The researchers also demonstrated in lab cultures and in mouse models of breast cancer that the pulsed, ultrasound-triggered hydrogel approach to drug delivery was more effective at stopping the growth of tumor cells than traditional, sustained-release drug therapy.

“Our approach counters the whole idea of sustained drug release and offers a double whammy,” said study author David J. Mooney, PhD, of the Harvard School of Engineering and Applied Sciences in Boston.

“We have shown that we can use the hydrogels repeatedly and turn the drug pulses on and off at will, and that the drug bursts in concert with the baseline low-level drug delivery seems to be particularly effective in killing cancer cells.”

Self-healing hydrogel

Key to the researchers’ success in designing a hydrogel that self-heals was choosing the right kind of hydrogel with the right kind of drug and applying the right intensity of ultrasound.

“We were able to trigger our system with a level of ultrasound that was much lower than high-intensity focused ultrasound that is used clinically to heat and destroy tumors,” said study author Cathal Kearney, PhD, of the Royal College of Surgeons in Ireland. “The careful selection of materials and properties make it a reversible process.”

The team carried out the majority of their work for this study with a gel made out of alginate, a natural polysaccharide from algae that is held together with calcium ions.

In a series of tests, they found that, with the right level of ultrasound, the bonds break up and enable the gel to release its drug cargo. But as long as the gel is in the presence of more calcium, the bonds reform and the gel self-heals.

Drug testing

Once the researchers knew the gel would self-heal, they tested out a drug they suspected it would hold well: the chemotherapy drug mitoxantrone.

Sure enough, the ultrasound triggered the gel to release the blue-colored drug, as indicated by the newly blue color of the surrounding medium. Just a single ultrasound dose was effective, and the gel reformed after it was disrupted, making multiple cycles possible.

Next, the team tested the treatment in mouse models of breast cancer. They injected the drug-laden gel close to the tumors.

Over the course of 6 months, the mice that received a low-level, sustained release of the drug with a daily concentrated pulse of ultrasound (2.5 minutes) fared significantly better than mice treated the same but without ultrasound.

In contrast to controls, the tumors in the ultrasound-treated mice did not grow substantially. And the mice survived for an additional 80 days.

Potential applications

The researchers believe their technique could help improve cancer treatment and other therapies requiring drugs to be delivered at the right place and the right time—from post-surgery pain medications to protein-based drugs that require daily injections.

It requires an initial injection of the hydrogel, but the approach could be a much less traumatic, minimally invasive, and more effective method of drug delivery than current methods, Dr Mooney said.

The researchers also found their hydrogel can release cargo other than drugs, including proteins and condensed plasmid DNA. This lays the groundwork for using these hydrogels for tissue regeneration and gene therapy.

Dr Mooney said he and his colleagues plan to explore these potential applications, as well as the possibility of unleashing 2 different drugs independently from the same hydrogel.

Hydrogels

Credit: Kathy Atkinson

Researchers have devised a novel way to deliver chemotherapy drugs “on demand,” according to a paper published in Proceedings of the National Academy of Sciences.

The team loaded a biocompatible hydrogel with a chemotherapy drug and used ultrasound to trigger the gel to release the drug.

Like many other injectable gels, this one gradually releases a low level of the drug by diffusion over time. But the new hydrogel differs from others in a key way.

Researchers previously applied ultrasound to gels to temporarily increase doses of drug, but that approach was a one-shot deal, as the ultrasound was used to destroy those gels.

In the current study, the researchers used ultrasound to temporarily disrupt the gel so that it released short, high-dose bursts of the drug. But when they stopped the ultrasound, the hydrogels self-healed.

By closing back up, they were ready to go for the next “on demand” drug burst, providing a way to administer drugs with a greater level of control than was possible before.

The researchers also demonstrated in lab cultures and in mouse models of breast cancer that the pulsed, ultrasound-triggered hydrogel approach to drug delivery was more effective at stopping the growth of tumor cells than traditional, sustained-release drug therapy.

“Our approach counters the whole idea of sustained drug release and offers a double whammy,” said study author David J. Mooney, PhD, of the Harvard School of Engineering and Applied Sciences in Boston.

“We have shown that we can use the hydrogels repeatedly and turn the drug pulses on and off at will, and that the drug bursts in concert with the baseline low-level drug delivery seems to be particularly effective in killing cancer cells.”

Self-healing hydrogel

Key to the researchers’ success in designing a hydrogel that self-heals was choosing the right kind of hydrogel with the right kind of drug and applying the right intensity of ultrasound.

“We were able to trigger our system with a level of ultrasound that was much lower than high-intensity focused ultrasound that is used clinically to heat and destroy tumors,” said study author Cathal Kearney, PhD, of the Royal College of Surgeons in Ireland. “The careful selection of materials and properties make it a reversible process.”

The team carried out the majority of their work for this study with a gel made out of alginate, a natural polysaccharide from algae that is held together with calcium ions.

In a series of tests, they found that, with the right level of ultrasound, the bonds break up and enable the gel to release its drug cargo. But as long as the gel is in the presence of more calcium, the bonds reform and the gel self-heals.

Drug testing

Once the researchers knew the gel would self-heal, they tested out a drug they suspected it would hold well: the chemotherapy drug mitoxantrone.

Sure enough, the ultrasound triggered the gel to release the blue-colored drug, as indicated by the newly blue color of the surrounding medium. Just a single ultrasound dose was effective, and the gel reformed after it was disrupted, making multiple cycles possible.

Next, the team tested the treatment in mouse models of breast cancer. They injected the drug-laden gel close to the tumors.

Over the course of 6 months, the mice that received a low-level, sustained release of the drug with a daily concentrated pulse of ultrasound (2.5 minutes) fared significantly better than mice treated the same but without ultrasound.

In contrast to controls, the tumors in the ultrasound-treated mice did not grow substantially. And the mice survived for an additional 80 days.

Potential applications

The researchers believe their technique could help improve cancer treatment and other therapies requiring drugs to be delivered at the right place and the right time—from post-surgery pain medications to protein-based drugs that require daily injections.

It requires an initial injection of the hydrogel, but the approach could be a much less traumatic, minimally invasive, and more effective method of drug delivery than current methods, Dr Mooney said.

The researchers also found their hydrogel can release cargo other than drugs, including proteins and condensed plasmid DNA. This lays the groundwork for using these hydrogels for tissue regeneration and gene therapy.

Dr Mooney said he and his colleagues plan to explore these potential applications, as well as the possibility of unleashing 2 different drugs independently from the same hydrogel.

Doctor consults with a family

Credit: Rhoda Baer

A new analysis suggests family dysfunction is the greatest predictor of emotional and behavioral problems among children who have a parent with cancer.

Other variables, such as the child’s age, did not predict the risk as accurately.

And illness-related factors, such as the parent’s prognosis, did not appear to have an impact at all.

Birgit Möller, PhD, of the University Medical Center Hamburg-Eppendorf in Germany, and her colleagues reported these findings in Cancer.

The researchers evaluated 235 families in which at least 1 parent was diagnosed with cancer. This included 402 parents and 324 children aged 11 to 21 years. Parents and children completed questionnaires that assessed emotional and behavioral health.

Responses suggested that children of cancer patients have higher-than-average levels of emotional and behavioral symptoms.

The overall mean values for emotional and behavioral problems—from both the parents’ and children’s perspectives—were significantly higher in the study population than the average values from a representative non-cancer population.

General family functioning was the strongest predictor of children’s symptom status from both the parents’ and child’s perspectives.

The effects of the child’s age and gender on behavioral and emotional symptoms varied according to the subject asked. But none of the respondents reported an association between child adjustment and illness-related factors such as poor prognoses or recurrent illness.

Dr Möller noted that screening for child mental health problems, family dysfunction, and parental depression can be easily adopted into cancer care so that families in need of support can be identified.

“Additional training of oncologists, interdisciplinary approaches, and family-based mental health liaison services are recommended to meet the needs of minor

children and their families and to minimize negative long-term effects in children,” she said.

Dr Möller and her team have developed a preventive counseling program—called the Children of Somatically Ill Parents (COSIP) program—that focuses on family communication, involvement of family members, flexible problem solving, mutual support, and parenting issues.

Doctor consults with a family

Credit: Rhoda Baer

A new analysis suggests family dysfunction is the greatest predictor of emotional and behavioral problems among children who have a parent with cancer.

Other variables, such as the child’s age, did not predict the risk as accurately.

And illness-related factors, such as the parent’s prognosis, did not appear to have an impact at all.

Birgit Möller, PhD, of the University Medical Center Hamburg-Eppendorf in Germany, and her colleagues reported these findings in Cancer.

The researchers evaluated 235 families in which at least 1 parent was diagnosed with cancer. This included 402 parents and 324 children aged 11 to 21 years. Parents and children completed questionnaires that assessed emotional and behavioral health.

Responses suggested that children of cancer patients have higher-than-average levels of emotional and behavioral symptoms.

The overall mean values for emotional and behavioral problems—from both the parents’ and children’s perspectives—were significantly higher in the study population than the average values from a representative non-cancer population.

General family functioning was the strongest predictor of children’s symptom status from both the parents’ and child’s perspectives.

The effects of the child’s age and gender on behavioral and emotional symptoms varied according to the subject asked. But none of the respondents reported an association between child adjustment and illness-related factors such as poor prognoses or recurrent illness.

Dr Möller noted that screening for child mental health problems, family dysfunction, and parental depression can be easily adopted into cancer care so that families in need of support can be identified.

“Additional training of oncologists, interdisciplinary approaches, and family-based mental health liaison services are recommended to meet the needs of minor

children and their families and to minimize negative long-term effects in children,” she said.

Dr Möller and her team have developed a preventive counseling program—called the Children of Somatically Ill Parents (COSIP) program—that focuses on family communication, involvement of family members, flexible problem solving, mutual support, and parenting issues.

Doctor consults with a family

Credit: Rhoda Baer

A new analysis suggests family dysfunction is the greatest predictor of emotional and behavioral problems among children who have a parent with cancer.

Other variables, such as the child’s age, did not predict the risk as accurately.

And illness-related factors, such as the parent’s prognosis, did not appear to have an impact at all.

Birgit Möller, PhD, of the University Medical Center Hamburg-Eppendorf in Germany, and her colleagues reported these findings in Cancer.

The researchers evaluated 235 families in which at least 1 parent was diagnosed with cancer. This included 402 parents and 324 children aged 11 to 21 years. Parents and children completed questionnaires that assessed emotional and behavioral health.

Responses suggested that children of cancer patients have higher-than-average levels of emotional and behavioral symptoms.

The overall mean values for emotional and behavioral problems—from both the parents’ and children’s perspectives—were significantly higher in the study population than the average values from a representative non-cancer population.

General family functioning was the strongest predictor of children’s symptom status from both the parents’ and child’s perspectives.

The effects of the child’s age and gender on behavioral and emotional symptoms varied according to the subject asked. But none of the respondents reported an association between child adjustment and illness-related factors such as poor prognoses or recurrent illness.

Dr Möller noted that screening for child mental health problems, family dysfunction, and parental depression can be easily adopted into cancer care so that families in need of support can be identified.

“Additional training of oncologists, interdisciplinary approaches, and family-based mental health liaison services are recommended to meet the needs of minor

children and their families and to minimize negative long-term effects in children,” she said.

Dr Möller and her team have developed a preventive counseling program—called the Children of Somatically Ill Parents (COSIP) program—that focuses on family communication, involvement of family members, flexible problem solving, mutual support, and parenting issues.

Doctor consults with a cancer

patient and her father

Credit: Rhoda Baer

A new questionnaire can measure a cancer patient’s risk for financial stress, according to a paper published in Cancer.

Researchers developed the 11-item questionnaire, called the COmprehensive Score for financial Toxicity (COST), through conversations with more than 150 cancer patients.

The team used the term “financial toxicity” to describe the expense, anxiety, and loss of confidence confronting patients who face big, unpredictable costs of cancer treatment.

And the researchers said financial toxicity can be considered another side effect of cancer care.

“Few physicians discuss this increasingly significant side effect with their patients,” said study author Jonas de Souza, MD, of the University of Chicago Medicine in Illinois.

“Physicians aren’t trained to do this. It makes them, as well as patients, feel uncomfortable. [However,] we believe that a thoughtful, concise tool that could help predict a patient’s risk for financial toxicity might open the lines of communication. This gives us a way to launch that discussion.”

Development of the COST questionnaire began with a literature review and a series of extensive interviews. Dr de Souza and his colleagues spoke with 20 patients and 6 cancer professionals, as well as nurses and social workers, and this produced a list of 147 questions.

The researchers pared the list down to 58 questions. Then, they asked 35 patients to help them decide which of the remaining questions were the most important. And the patients narrowed the list down to 30.

“In the end, 155 patients led us, with some judicious editing, to a set of 11 statements,” Dr de Souza said. “This was sufficiently brief to prevent annoying those responding to the questions but thorough enough to get us the information we need.”

All 11 entries are short and easy to understand, according to the researchers. For example, item 2 states, “My out-of-pocket medical expenses are more than I thought they would be.” And item 7 states, “I am able to meet my monthly expenses.”

For each question, patients choose from 5 potential responses: “not at all”, “a little bit,” “somewhat,” “quite a bit,” or “very much.”

Learning how a patient responds may help caregivers determine who is likely to need education, financial counseling, or referral to a support network. The quiz may also predict who is likely to have problems and require interventions.

All patients who helped develop the study had been in treatment for at least 2 months and had received bills. Excluding the top 10% and the bottom 10%, patients in the study earned between $37,000 and $111,000. The median annual income for these patients was about $63,000.

The researchers expected that financial toxicity would correlate with income.

“But, in our small sample, that did not hold up,” Dr de Souza said. “People with less education seemed to have more financial distress, but variations in income did not make much difference. We need bigger studies to confirm that, but at least we now have a tool we can use to study this.”

The researchers are now conducting a larger study to validate these findings and correlate the newly developed scale with quality of life and anxiety in cancer patients.

“We need to assess outcomes that are important for patients,” Dr de Souza said. “[T]his is another important piece of information in the shared-decision-making process.”

Doctor consults with a cancer

patient and her father

Credit: Rhoda Baer

A new questionnaire can measure a cancer patient’s risk for financial stress, according to a paper published in Cancer.

Researchers developed the 11-item questionnaire, called the COmprehensive Score for financial Toxicity (COST), through conversations with more than 150 cancer patients.

The team used the term “financial toxicity” to describe the expense, anxiety, and loss of confidence confronting patients who face big, unpredictable costs of cancer treatment.

And the researchers said financial toxicity can be considered another side effect of cancer care.

“Few physicians discuss this increasingly significant side effect with their patients,” said study author Jonas de Souza, MD, of the University of Chicago Medicine in Illinois.

“Physicians aren’t trained to do this. It makes them, as well as patients, feel uncomfortable. [However,] we believe that a thoughtful, concise tool that could help predict a patient’s risk for financial toxicity might open the lines of communication. This gives us a way to launch that discussion.”

Development of the COST questionnaire began with a literature review and a series of extensive interviews. Dr de Souza and his colleagues spoke with 20 patients and 6 cancer professionals, as well as nurses and social workers, and this produced a list of 147 questions.

The researchers pared the list down to 58 questions. Then, they asked 35 patients to help them decide which of the remaining questions were the most important. And the patients narrowed the list down to 30.

“In the end, 155 patients led us, with some judicious editing, to a set of 11 statements,” Dr de Souza said. “This was sufficiently brief to prevent annoying those responding to the questions but thorough enough to get us the information we need.”

All 11 entries are short and easy to understand, according to the researchers. For example, item 2 states, “My out-of-pocket medical expenses are more than I thought they would be.” And item 7 states, “I am able to meet my monthly expenses.”

For each question, patients choose from 5 potential responses: “not at all”, “a little bit,” “somewhat,” “quite a bit,” or “very much.”

Learning how a patient responds may help caregivers determine who is likely to need education, financial counseling, or referral to a support network. The quiz may also predict who is likely to have problems and require interventions.

All patients who helped develop the study had been in treatment for at least 2 months and had received bills. Excluding the top 10% and the bottom 10%, patients in the study earned between $37,000 and $111,000. The median annual income for these patients was about $63,000.

The researchers expected that financial toxicity would correlate with income.

“But, in our small sample, that did not hold up,” Dr de Souza said. “People with less education seemed to have more financial distress, but variations in income did not make much difference. We need bigger studies to confirm that, but at least we now have a tool we can use to study this.”

The researchers are now conducting a larger study to validate these findings and correlate the newly developed scale with quality of life and anxiety in cancer patients.

“We need to assess outcomes that are important for patients,” Dr de Souza said. “[T]his is another important piece of information in the shared-decision-making process.”

Doctor consults with a cancer

patient and her father

Credit: Rhoda Baer

A new questionnaire can measure a cancer patient’s risk for financial stress, according to a paper published in Cancer.

Researchers developed the 11-item questionnaire, called the COmprehensive Score for financial Toxicity (COST), through conversations with more than 150 cancer patients.

The team used the term “financial toxicity” to describe the expense, anxiety, and loss of confidence confronting patients who face big, unpredictable costs of cancer treatment.

And the researchers said financial toxicity can be considered another side effect of cancer care.

“Few physicians discuss this increasingly significant side effect with their patients,” said study author Jonas de Souza, MD, of the University of Chicago Medicine in Illinois.

“Physicians aren’t trained to do this. It makes them, as well as patients, feel uncomfortable. [However,] we believe that a thoughtful, concise tool that could help predict a patient’s risk for financial toxicity might open the lines of communication. This gives us a way to launch that discussion.”

Development of the COST questionnaire began with a literature review and a series of extensive interviews. Dr de Souza and his colleagues spoke with 20 patients and 6 cancer professionals, as well as nurses and social workers, and this produced a list of 147 questions.

The researchers pared the list down to 58 questions. Then, they asked 35 patients to help them decide which of the remaining questions were the most important. And the patients narrowed the list down to 30.

“In the end, 155 patients led us, with some judicious editing, to a set of 11 statements,” Dr de Souza said. “This was sufficiently brief to prevent annoying those responding to the questions but thorough enough to get us the information we need.”

All 11 entries are short and easy to understand, according to the researchers. For example, item 2 states, “My out-of-pocket medical expenses are more than I thought they would be.” And item 7 states, “I am able to meet my monthly expenses.”

For each question, patients choose from 5 potential responses: “not at all”, “a little bit,” “somewhat,” “quite a bit,” or “very much.”

Learning how a patient responds may help caregivers determine who is likely to need education, financial counseling, or referral to a support network. The quiz may also predict who is likely to have problems and require interventions.

All patients who helped develop the study had been in treatment for at least 2 months and had received bills. Excluding the top 10% and the bottom 10%, patients in the study earned between $37,000 and $111,000. The median annual income for these patients was about $63,000.

The researchers expected that financial toxicity would correlate with income.

“But, in our small sample, that did not hold up,” Dr de Souza said. “People with less education seemed to have more financial distress, but variations in income did not make much difference. We need bigger studies to confirm that, but at least we now have a tool we can use to study this.”

The researchers are now conducting a larger study to validate these findings and correlate the newly developed scale with quality of life and anxiety in cancer patients.

“We need to assess outcomes that are important for patients,” Dr de Souza said. “[T]his is another important piece of information in the shared-decision-making process.”

Doctor and patient

Credit: CDC

The medical technology company CareFusion has announced a Class I recall of its Alaris Pump model 8100, software version 9.1.18.

This large-volume infusion pump is used for the delivery of fluids, medicines, blood, and blood products.

Version 9.1.18 of the Alaris Pump model 8100 is being recalled due to the possibility of a software failure in which the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used.

There have been no reports of adverse events or deaths related to this malfunction, but it does pose risks. CareFusion has received 1 report where the device malfunctioned when the “Delay Until” option was selected.

The software failure also prevents the pump from properly delivering a multidose infusion under the following conditions:

• When the first dose is programmed to infuse when the system time is earlier than 7 pm and a subsequent dose is intended to infuse between 7 pm and 11:59 pm
• When the first dose is programmed to infuse when the system time is between 7 pm and 11:59 pm and a subsequent dose is intended to infuse between 12 am and 6:59 pm the next day.

If the infusion starts earlier or later than intended and is not immediately detected and stopped, serious injury or death could result. Therefore, healthcare professionals should not use the Alaris Pump module “Delay Until” option or the “Multidose” option.

However, CareFusion said it has identified the root cause of the issue and recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. The company said it will contact all affected customers to schedule the installation of software version 9.1.17.

As an interim guidance, customers may update their dataset to disable both “Delay” options (“Delay Until” and “Delay For”) and/or the “Multidose” option across all profiles to prevent the use of these features. These are shared configurations with the Alaris Syringe module and, if disabled, would prevent use of these features with the Alaris Syringe module as well.

For more information on this recall, see CareFusion’s recall notice, or contact the CareFusion Support Center at 888-562-6018 or SupportCenter@carefusion.com.

To report adverse reactions or quality problems associated with this product, visit the Food and Drug Administration’s MedWatch website.

Doctor and patient

Credit: CDC

The medical technology company CareFusion has announced a Class I recall of its Alaris Pump model 8100, software version 9.1.18.

This large-volume infusion pump is used for the delivery of fluids, medicines, blood, and blood products.

Version 9.1.18 of the Alaris Pump model 8100 is being recalled due to the possibility of a software failure in which the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used.

There have been no reports of adverse events or deaths related to this malfunction, but it does pose risks. CareFusion has received 1 report where the device malfunctioned when the “Delay Until” option was selected.

The software failure also prevents the pump from properly delivering a multidose infusion under the following conditions:

• When the first dose is programmed to infuse when the system time is earlier than 7 pm and a subsequent dose is intended to infuse between 7 pm and 11:59 pm
• When the first dose is programmed to infuse when the system time is between 7 pm and 11:59 pm and a subsequent dose is intended to infuse between 12 am and 6:59 pm the next day.

If the infusion starts earlier or later than intended and is not immediately detected and stopped, serious injury or death could result. Therefore, healthcare professionals should not use the Alaris Pump module “Delay Until” option or the “Multidose” option.

However, CareFusion said it has identified the root cause of the issue and recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. The company said it will contact all affected customers to schedule the installation of software version 9.1.17.

As an interim guidance, customers may update their dataset to disable both “Delay” options (“Delay Until” and “Delay For”) and/or the “Multidose” option across all profiles to prevent the use of these features. These are shared configurations with the Alaris Syringe module and, if disabled, would prevent use of these features with the Alaris Syringe module as well.

For more information on this recall, see CareFusion’s recall notice, or contact the CareFusion Support Center at 888-562-6018 or SupportCenter@carefusion.com.

To report adverse reactions or quality problems associated with this product, visit the Food and Drug Administration’s MedWatch website.

Doctor and patient

Credit: CDC

The medical technology company CareFusion has announced a Class I recall of its Alaris Pump model 8100, software version 9.1.18.

This large-volume infusion pump is used for the delivery of fluids, medicines, blood, and blood products.

Version 9.1.18 of the Alaris Pump model 8100 is being recalled due to the possibility of a software failure in which the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used.

There have been no reports of adverse events or deaths related to this malfunction, but it does pose risks. CareFusion has received 1 report where the device malfunctioned when the “Delay Until” option was selected.

The software failure also prevents the pump from properly delivering a multidose infusion under the following conditions:

• When the first dose is programmed to infuse when the system time is earlier than 7 pm and a subsequent dose is intended to infuse between 7 pm and 11:59 pm
• When the first dose is programmed to infuse when the system time is between 7 pm and 11:59 pm and a subsequent dose is intended to infuse between 12 am and 6:59 pm the next day.

If the infusion starts earlier or later than intended and is not immediately detected and stopped, serious injury or death could result. Therefore, healthcare professionals should not use the Alaris Pump module “Delay Until” option or the “Multidose” option.

However, CareFusion said it has identified the root cause of the issue and recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. The company said it will contact all affected customers to schedule the installation of software version 9.1.17.

As an interim guidance, customers may update their dataset to disable both “Delay” options (“Delay Until” and “Delay For”) and/or the “Multidose” option across all profiles to prevent the use of these features. These are shared configurations with the Alaris Syringe module and, if disabled, would prevent use of these features with the Alaris Syringe module as well.

For more information on this recall, see CareFusion’s recall notice, or contact the CareFusion Support Center at 888-562-6018 or SupportCenter@carefusion.com.

To report adverse reactions or quality problems associated with this product, visit the Food and Drug Administration’s MedWatch website.

Blood for transfusion

Credit: Daniel Gay

Hospira, Inc., has issued a Class I recall of Abbott Acclaim infusion pumps and Hospira Acclaim Encore infusion pumps, after receiving reports of broken door assemblies on these products.

If a door assembly breaks, the door may not close properly and an over-infusion or a delay of therapy may occur.

If the door cannot be closed, the pump cannot be used, and this can result in a delay of therapy.

Use of these products may cause serious adverse events, including death.

These pumps are used to deliver hydration fluids, drugs, blood and blood fractions, intravenous nutritionals, and enteral nutritionals.

The affected Abbott Acclaim Infusion Pumps, list Number 12032, were manufactured from February 1998 to November 1998 and distributed from September 1998 through February 2004.

The affected Hospira Acclaim Encore infusion pumps, list Number 12237, were manufactured from February 1997 to February 2010 and distributed from July 1999 through November 2013.

Hospira is recommending that users inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks prior to programming a therapy, by taking the following steps:

1. After inserting the tubing (with the roller clamp closed) and closing the door handle against the infusion pump, check that the door is fully closed.

If a pump has a door that does not close properly and a gap or separation exists between the completely closed door and the pump itself, remove the pump from clinical service, and call Hospira at 1-800-441-4100 (M-F, 8am-5pm, CT). If the door closes correctly, proceed to Step 2.

2. If the door closes correctly and a gap or separation does not exist between the completely closed door and the pump itself, check that there is no free flow activity in the drip chamber of the administration set by opening the roller clamp.

If free flow is detected, close the roller clamp, remove the pump from clinical service, and call Hospira at 1-800-441-4100 (M-F, 8am-5pm, CT).

3. If no issues are found through steps 1 and 2, the pump is acceptable for use. However, healthcare professionals should still ensure that anyone in their facility who might use these products is made aware of this safety notification and the recommended actions.

Healthcare professionals and patients can report adverse events or side effects related to the use of these products to the FDA’s MedWatch Program.

Blood for transfusion

Credit: Daniel Gay

Hospira, Inc., has issued a Class I recall of Abbott Acclaim infusion pumps and Hospira Acclaim Encore infusion pumps, after receiving reports of broken door assemblies on these products.

If a door assembly breaks, the door may not close properly and an over-infusion or a delay of therapy may occur.

If the door cannot be closed, the pump cannot be used, and this can result in a delay of therapy.

Use of these products may cause serious adverse events, including death.

These pumps are used to deliver hydration fluids, drugs, blood and blood fractions, intravenous nutritionals, and enteral nutritionals.

The affected Abbott Acclaim Infusion Pumps, list Number 12032, were manufactured from February 1998 to November 1998 and distributed from September 1998 through February 2004.

The affected Hospira Acclaim Encore infusion pumps, list Number 12237, were manufactured from February 1997 to February 2010 and distributed from July 1999 through November 2013.

Hospira is recommending that users inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks prior to programming a therapy, by taking the following steps:

1. After inserting the tubing (with the roller clamp closed) and closing the door handle against the infusion pump, check that the door is fully closed.

If a pump has a door that does not close properly and a gap or separation exists between the completely closed door and the pump itself, remove the pump from clinical service, and call Hospira at 1-800-441-4100 (M-F, 8am-5pm, CT). If the door closes correctly, proceed to Step 2.

2. If the door closes correctly and a gap or separation does not exist between the completely closed door and the pump itself, check that there is no free flow activity in the drip chamber of the administration set by opening the roller clamp.

If free flow is detected, close the roller clamp, remove the pump from clinical service, and call Hospira at 1-800-441-4100 (M-F, 8am-5pm, CT).

3. If no issues are found through steps 1 and 2, the pump is acceptable for use. However, healthcare professionals should still ensure that anyone in their facility who might use these products is made aware of this safety notification and the recommended actions.

Healthcare professionals and patients can report adverse events or side effects related to the use of these products to the FDA’s MedWatch Program.

Blood for transfusion

Credit: Daniel Gay

Hospira, Inc., has issued a Class I recall of Abbott Acclaim infusion pumps and Hospira Acclaim Encore infusion pumps, after receiving reports of broken door assemblies on these products.

If a door assembly breaks, the door may not close properly and an over-infusion or a delay of therapy may occur.

If the door cannot be closed, the pump cannot be used, and this can result in a delay of therapy.

Use of these products may cause serious adverse events, including death.

These pumps are used to deliver hydration fluids, drugs, blood and blood fractions, intravenous nutritionals, and enteral nutritionals.

The affected Abbott Acclaim Infusion Pumps, list Number 12032, were manufactured from February 1998 to November 1998 and distributed from September 1998 through February 2004.

The affected Hospira Acclaim Encore infusion pumps, list Number 12237, were manufactured from February 1997 to February 2010 and distributed from July 1999 through November 2013.

Hospira is recommending that users inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks prior to programming a therapy, by taking the following steps:

1. After inserting the tubing (with the roller clamp closed) and closing the door handle against the infusion pump, check that the door is fully closed.

If a pump has a door that does not close properly and a gap or separation exists between the completely closed door and the pump itself, remove the pump from clinical service, and call Hospira at 1-800-441-4100 (M-F, 8am-5pm, CT). If the door closes correctly, proceed to Step 2.

2. If the door closes correctly and a gap or separation does not exist between the completely closed door and the pump itself, check that there is no free flow activity in the drip chamber of the administration set by opening the roller clamp.

If free flow is detected, close the roller clamp, remove the pump from clinical service, and call Hospira at 1-800-441-4100 (M-F, 8am-5pm, CT).

3. If no issues are found through steps 1 and 2, the pump is acceptable for use. However, healthcare professionals should still ensure that anyone in their facility who might use these products is made aware of this safety notification and the recommended actions.

Healthcare professionals and patients can report adverse events or side effects related to the use of these products to the FDA’s MedWatch Program.

Doctor and patient

Credit: CDC

Hospira, Inc., has announced a medical device correction for the GemStar Docking Station (list number 13075), used in conjunction with the GemStar infusion pump.

The correction follows customer reports of 2 malfunctions that may occur with the docking station.

The company is not recalling the product but is notifying US customers of the potential malfunctions and providing instructions for overriding these errors.

The errors could potentially cause delays or interruptions in therapy. And this might result in serious adverse events or death, but there have been no such events reported to date.

Potential malfunctions

The GemStar Docking Station is an accessory to the GemStar infusion pump (sold separately) and provides an alternate power source to the GemStar pump.

When the docking station is used in conjunction with a GemStar Phase 3 pump (List 13000, 13100 or 13150), there is a risk that the GemStar Phase 3 pump may fail to power up while connected to the docking station.

When a GemStar Phase 3 (List 13000, 13100 or 13150) or GemStar Phase 4 pump (List 13086, 13087 or 13088) is used in conjunction with both a docking station and an external battery pack accessory (List 13073), the GemStar pump may display error code 11/003 and give an audible alarm, indicating excessive input voltage from the external sources.

If the GemStar pump detects what is perceived to be more than 3.6 volts, as measured on the external voltage input, the pump will stop the infusion. This will trigger an audible alarm, and the device will display alarm code 11/003.

If a GemStar fails to power up or the 11/003 error code stops an infusion, a patient’s therapy might be delayed or interrupted. This could result in significant injury or death, although there have been no reports of death or serious injury associated with these malfunctions to date.

The products impacted by these issues have been in distribution since February 2002.

Responding to/preventing malfunctions

Hospira is advising that healthcare professionals weigh the risk/benefit to patients associated with the use of the docking station when administering critical therapies. Clinicians should consider the use of an alternative pump, particularly in patients for whom a delay or interruption of therapy could result in serious injury or death.

However, the company says there is no need to return the GemStar Docking Station at this time. Instead, Hospira recommends that users take the following actions.

To avoid a failure to power up, turn on the pump before connecting it with the docking station. This will prevent the failure to power up.

To mitigate the potential for an 11/003 error code, remove the external battery pack accessory (List 13073) from the docking station and pump prior to installing the pump in the docking station.

In addition, clinicians should stop using a docking station in conjunction with an external battery pack accessory (List 13073). Contact Hospira to discuss an appropriate alternative option.

Docking station users who experience a failure to power up or an 11/003 error code should report the issue to Hospira by calling 1-800-441-4100 (M-F, 8am-5pm CT) or emailing ProductComplaintsPP@hospira.com.

For additional assistance or to obtain a copy of the Urgent Medical Device Correction letter and/or a reply form, contact Stericycle at 1-866-792-5451 (M-F, 8am-5pm ET).

On May 1, 2013, Hospira announced that it would begin the process of retiring the GemStar family of infusion devices in accordance with the company’s global device strategy. As of July 31, 2015, Hospira will consider the products within the GemStar Infusion System family retired and will no longer support them.

Adverse reactions or quality problems related to the GemStar Docking Station can be reported to the US Food and Drug Administration’s MedWatch Program.

Doctor and patient

Credit: CDC

Hospira, Inc., has announced a medical device correction for the GemStar Docking Station (list number 13075), used in conjunction with the GemStar infusion pump.

The correction follows customer reports of 2 malfunctions that may occur with the docking station.

The company is not recalling the product but is notifying US customers of the potential malfunctions and providing instructions for overriding these errors.

The errors could potentially cause delays or interruptions in therapy. And this might result in serious adverse events or death, but there have been no such events reported to date.

Potential malfunctions

The GemStar Docking Station is an accessory to the GemStar infusion pump (sold separately) and provides an alternate power source to the GemStar pump.

When the docking station is used in conjunction with a GemStar Phase 3 pump (List 13000, 13100 or 13150), there is a risk that the GemStar Phase 3 pump may fail to power up while connected to the docking station.

When a GemStar Phase 3 (List 13000, 13100 or 13150) or GemStar Phase 4 pump (List 13086, 13087 or 13088) is used in conjunction with both a docking station and an external battery pack accessory (List 13073), the GemStar pump may display error code 11/003 and give an audible alarm, indicating excessive input voltage from the external sources.

If the GemStar pump detects what is perceived to be more than 3.6 volts, as measured on the external voltage input, the pump will stop the infusion. This will trigger an audible alarm, and the device will display alarm code 11/003.

If a GemStar fails to power up or the 11/003 error code stops an infusion, a patient’s therapy might be delayed or interrupted. This could result in significant injury or death, although there have been no reports of death or serious injury associated with these malfunctions to date.

The products impacted by these issues have been in distribution since February 2002.

Responding to/preventing malfunctions

Hospira is advising that healthcare professionals weigh the risk/benefit to patients associated with the use of the docking station when administering critical therapies. Clinicians should consider the use of an alternative pump, particularly in patients for whom a delay or interruption of therapy could result in serious injury or death.

However, the company says there is no need to return the GemStar Docking Station at this time. Instead, Hospira recommends that users take the following actions.

To avoid a failure to power up, turn on the pump before connecting it with the docking station. This will prevent the failure to power up.

To mitigate the potential for an 11/003 error code, remove the external battery pack accessory (List 13073) from the docking station and pump prior to installing the pump in the docking station.

In addition, clinicians should stop using a docking station in conjunction with an external battery pack accessory (List 13073). Contact Hospira to discuss an appropriate alternative option.

Docking station users who experience a failure to power up or an 11/003 error code should report the issue to Hospira by calling 1-800-441-4100 (M-F, 8am-5pm CT) or emailing ProductComplaintsPP@hospira.com.

For additional assistance or to obtain a copy of the Urgent Medical Device Correction letter and/or a reply form, contact Stericycle at 1-866-792-5451 (M-F, 8am-5pm ET).

On May 1, 2013, Hospira announced that it would begin the process of retiring the GemStar family of infusion devices in accordance with the company’s global device strategy. As of July 31, 2015, Hospira will consider the products within the GemStar Infusion System family retired and will no longer support them.

Adverse reactions or quality problems related to the GemStar Docking Station can be reported to the US Food and Drug Administration’s MedWatch Program.

Doctor and patient

Credit: CDC

Hospira, Inc., has announced a medical device correction for the GemStar Docking Station (list number 13075), used in conjunction with the GemStar infusion pump.

The correction follows customer reports of 2 malfunctions that may occur with the docking station.

The company is not recalling the product but is notifying US customers of the potential malfunctions and providing instructions for overriding these errors.

The errors could potentially cause delays or interruptions in therapy. And this might result in serious adverse events or death, but there have been no such events reported to date.

Potential malfunctions

The GemStar Docking Station is an accessory to the GemStar infusion pump (sold separately) and provides an alternate power source to the GemStar pump.

When the docking station is used in conjunction with a GemStar Phase 3 pump (List 13000, 13100 or 13150), there is a risk that the GemStar Phase 3 pump may fail to power up while connected to the docking station.

When a GemStar Phase 3 (List 13000, 13100 or 13150) or GemStar Phase 4 pump (List 13086, 13087 or 13088) is used in conjunction with both a docking station and an external battery pack accessory (List 13073), the GemStar pump may display error code 11/003 and give an audible alarm, indicating excessive input voltage from the external sources.

If the GemStar pump detects what is perceived to be more than 3.6 volts, as measured on the external voltage input, the pump will stop the infusion. This will trigger an audible alarm, and the device will display alarm code 11/003.

If a GemStar fails to power up or the 11/003 error code stops an infusion, a patient’s therapy might be delayed or interrupted. This could result in significant injury or death, although there have been no reports of death or serious injury associated with these malfunctions to date.

The products impacted by these issues have been in distribution since February 2002.

Responding to/preventing malfunctions

Hospira is advising that healthcare professionals weigh the risk/benefit to patients associated with the use of the docking station when administering critical therapies. Clinicians should consider the use of an alternative pump, particularly in patients for whom a delay or interruption of therapy could result in serious injury or death.

However, the company says there is no need to return the GemStar Docking Station at this time. Instead, Hospira recommends that users take the following actions.

To avoid a failure to power up, turn on the pump before connecting it with the docking station. This will prevent the failure to power up.

To mitigate the potential for an 11/003 error code, remove the external battery pack accessory (List 13073) from the docking station and pump prior to installing the pump in the docking station.

In addition, clinicians should stop using a docking station in conjunction with an external battery pack accessory (List 13073). Contact Hospira to discuss an appropriate alternative option.

Docking station users who experience a failure to power up or an 11/003 error code should report the issue to Hospira by calling 1-800-441-4100 (M-F, 8am-5pm CT) or emailing ProductComplaintsPP@hospira.com.

For additional assistance or to obtain a copy of the Urgent Medical Device Correction letter and/or a reply form, contact Stericycle at 1-866-792-5451 (M-F, 8am-5pm ET).

On May 1, 2013, Hospira announced that it would begin the process of retiring the GemStar family of infusion devices in accordance with the company’s global device strategy. As of July 31, 2015, Hospira will consider the products within the GemStar Infusion System family retired and will no longer support them.

Adverse reactions or quality problems related to the GemStar Docking Station can be reported to the US Food and Drug Administration’s MedWatch Program.