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Biomarker duo rapidly identifies serious bacterial infections
MALMO, SWEDEN – The combination of serum procalcitonin and C-reactive protein levels upon admission to a pediatric ICU displayed high utility for early diagnosis of serious bacterial infection in critically ill children in a large prospective observational study presented at the annual meeting of the European Society for Paediatric Infectious Diseases.
This winning combination significantly outperformed neutrophil gelatinase-associated lipocalin, activated partial thromboplastin time, and resistin, both individually and in various combinations, for the vital task of making a rapid distinction between infectious and noninfectious causes of pediatric systemic inflammatory response syndrome, reported Enitan D. Carrol, MD, professor of pediatric infection at the University of Liverpool (England).
“One of the clinical dilemmas we face in intensive care is being able to differentiate between infectious and noninfectious causes of systemic inflammatory response syndrome. This is important because we need to identify which children have life-threatening infections so that we can promptly initiate antimicrobial therapy,” she explained.
One in four deaths in pediatric ICUs are infection related, Dr. Carrol noted.
“There is an urgent need for infection markers which, firstly, change early in the course of bacterial infection, secondly, correlate with real-time clinical progression, and thirdly, have a rapid turn-around time to allow effective clinical decision making,” she observed.
The combination of procalcitonin and C-reactive protein (CRP) levels measured at admission fits the bill, Dr. Carrol continued. Of the five biomarkers evaluated in her study – all backed by some supporting evidence of efficacy in earlier studies – the top two individual performers in terms of negative predictive value (NPV) were a CRP less than 4.2 mg/dL with a negative NPV of 99%, and a procalcitonin less than 1.52 ng/mL with an NPV of 96%. The positive predictive value of each of the biomarkers was 37%. The sensitivity and specificity of procalcitonin for diagnosis of serious bacterial infection were 78% and 80%, respectively. For CRP, the figures were 93% and 76%.
The combination of procalcitonin and CRP outperformed a multitude of other two-, three-, and four-biomarker combinations tested, with an area under the curve of 93% for combined sensitivity and specificity.
The study included 657 children admitted to the pediatric ICU at Alder Hey Children’s Hospital in Liverpool with systemic inflammatory response syndrome. All had blood samples measured for the five biomarkers on days 1-7. Clinicians were blinded as to the biomarker results. Ninety-two (14%) patients were ultimately found to have a serious bacterial infection – essentially, bacterial meningitis or septic shock – and 565 (86%) had a nonbacterial etiology.
The 28-day mortality rate was 9% in the group with serious bacterial infection, significantly higher than the 2% rate in the group with other causes of their systemic inflammatory response syndrome.
Longitudinal trends in procalcitonin and CRP as evidenced in the study can be used in clinical decision making, according to Dr. Carrol. Mean values of procalcitonin plummeted by 80% from day 1 to day 5 in response to antimicrobial therapy in the group with serious bacterial infections. In contrast, CRP levels rose sharply from day 1 to a peak on day 2, then fell, although the 50% drop from day 2 to day 5 in response to antimicrobial therapy wasn’t as pronounced as the change in procalcitonin.
“There is an additive benefit for both biomarkers compared with CRP alone. The problem with CRP on admission, as I’ve demonstrated in this study, is it often hasn’t risen yet early after admission. So although it gave the best area under the curve of any of the biomarkers, I think that combined with procalcitonin you get a much better descriminator,” Dr. Carrol said.
The median duration of ICU stay in the patients with serious bacterial infection at admission was 5 days, compared with 3 days when the cause of systemic inflammatory response syndrome lay elsewhere. Their median duration of ventilation was significantly longer, too: 4 days versus 2 in children without a serious bacterial infection.
Stepwise logistic regression analysis pinpointed several clinical variables as being associated with prolonged ICU stay.
In addition, initiation of antibiotic therapy prior to admission to the pediatric ICU was associated with a 50% reduction in the likelihood of a prolonged ICU stay. “This reflects the fact that early antibiotics give you a better prognosis if you have sepsis,” according to Dr. Carrol.
She and her coinvestigators now have embarked on a multicenter U.K. study looking at the impact of procalcitonin to guide duration of antimicrobial therapy in critically ill children.
The Alder Hey study was funded by the U.K. National Institute for Health Research. Dr. Carrol reported having no financial conflicts. Although she serves as a consultant to several health care companies, all remuneration goes directly to the University of Liverpool.
MALMO, SWEDEN – The combination of serum procalcitonin and C-reactive protein levels upon admission to a pediatric ICU displayed high utility for early diagnosis of serious bacterial infection in critically ill children in a large prospective observational study presented at the annual meeting of the European Society for Paediatric Infectious Diseases.
This winning combination significantly outperformed neutrophil gelatinase-associated lipocalin, activated partial thromboplastin time, and resistin, both individually and in various combinations, for the vital task of making a rapid distinction between infectious and noninfectious causes of pediatric systemic inflammatory response syndrome, reported Enitan D. Carrol, MD, professor of pediatric infection at the University of Liverpool (England).
“One of the clinical dilemmas we face in intensive care is being able to differentiate between infectious and noninfectious causes of systemic inflammatory response syndrome. This is important because we need to identify which children have life-threatening infections so that we can promptly initiate antimicrobial therapy,” she explained.
One in four deaths in pediatric ICUs are infection related, Dr. Carrol noted.
“There is an urgent need for infection markers which, firstly, change early in the course of bacterial infection, secondly, correlate with real-time clinical progression, and thirdly, have a rapid turn-around time to allow effective clinical decision making,” she observed.
The combination of procalcitonin and C-reactive protein (CRP) levels measured at admission fits the bill, Dr. Carrol continued. Of the five biomarkers evaluated in her study – all backed by some supporting evidence of efficacy in earlier studies – the top two individual performers in terms of negative predictive value (NPV) were a CRP less than 4.2 mg/dL with a negative NPV of 99%, and a procalcitonin less than 1.52 ng/mL with an NPV of 96%. The positive predictive value of each of the biomarkers was 37%. The sensitivity and specificity of procalcitonin for diagnosis of serious bacterial infection were 78% and 80%, respectively. For CRP, the figures were 93% and 76%.
The combination of procalcitonin and CRP outperformed a multitude of other two-, three-, and four-biomarker combinations tested, with an area under the curve of 93% for combined sensitivity and specificity.
The study included 657 children admitted to the pediatric ICU at Alder Hey Children’s Hospital in Liverpool with systemic inflammatory response syndrome. All had blood samples measured for the five biomarkers on days 1-7. Clinicians were blinded as to the biomarker results. Ninety-two (14%) patients were ultimately found to have a serious bacterial infection – essentially, bacterial meningitis or septic shock – and 565 (86%) had a nonbacterial etiology.
The 28-day mortality rate was 9% in the group with serious bacterial infection, significantly higher than the 2% rate in the group with other causes of their systemic inflammatory response syndrome.
Longitudinal trends in procalcitonin and CRP as evidenced in the study can be used in clinical decision making, according to Dr. Carrol. Mean values of procalcitonin plummeted by 80% from day 1 to day 5 in response to antimicrobial therapy in the group with serious bacterial infections. In contrast, CRP levels rose sharply from day 1 to a peak on day 2, then fell, although the 50% drop from day 2 to day 5 in response to antimicrobial therapy wasn’t as pronounced as the change in procalcitonin.
“There is an additive benefit for both biomarkers compared with CRP alone. The problem with CRP on admission, as I’ve demonstrated in this study, is it often hasn’t risen yet early after admission. So although it gave the best area under the curve of any of the biomarkers, I think that combined with procalcitonin you get a much better descriminator,” Dr. Carrol said.
The median duration of ICU stay in the patients with serious bacterial infection at admission was 5 days, compared with 3 days when the cause of systemic inflammatory response syndrome lay elsewhere. Their median duration of ventilation was significantly longer, too: 4 days versus 2 in children without a serious bacterial infection.
Stepwise logistic regression analysis pinpointed several clinical variables as being associated with prolonged ICU stay.
In addition, initiation of antibiotic therapy prior to admission to the pediatric ICU was associated with a 50% reduction in the likelihood of a prolonged ICU stay. “This reflects the fact that early antibiotics give you a better prognosis if you have sepsis,” according to Dr. Carrol.
She and her coinvestigators now have embarked on a multicenter U.K. study looking at the impact of procalcitonin to guide duration of antimicrobial therapy in critically ill children.
The Alder Hey study was funded by the U.K. National Institute for Health Research. Dr. Carrol reported having no financial conflicts. Although she serves as a consultant to several health care companies, all remuneration goes directly to the University of Liverpool.
MALMO, SWEDEN – The combination of serum procalcitonin and C-reactive protein levels upon admission to a pediatric ICU displayed high utility for early diagnosis of serious bacterial infection in critically ill children in a large prospective observational study presented at the annual meeting of the European Society for Paediatric Infectious Diseases.
This winning combination significantly outperformed neutrophil gelatinase-associated lipocalin, activated partial thromboplastin time, and resistin, both individually and in various combinations, for the vital task of making a rapid distinction between infectious and noninfectious causes of pediatric systemic inflammatory response syndrome, reported Enitan D. Carrol, MD, professor of pediatric infection at the University of Liverpool (England).
“One of the clinical dilemmas we face in intensive care is being able to differentiate between infectious and noninfectious causes of systemic inflammatory response syndrome. This is important because we need to identify which children have life-threatening infections so that we can promptly initiate antimicrobial therapy,” she explained.
One in four deaths in pediatric ICUs are infection related, Dr. Carrol noted.
“There is an urgent need for infection markers which, firstly, change early in the course of bacterial infection, secondly, correlate with real-time clinical progression, and thirdly, have a rapid turn-around time to allow effective clinical decision making,” she observed.
The combination of procalcitonin and C-reactive protein (CRP) levels measured at admission fits the bill, Dr. Carrol continued. Of the five biomarkers evaluated in her study – all backed by some supporting evidence of efficacy in earlier studies – the top two individual performers in terms of negative predictive value (NPV) were a CRP less than 4.2 mg/dL with a negative NPV of 99%, and a procalcitonin less than 1.52 ng/mL with an NPV of 96%. The positive predictive value of each of the biomarkers was 37%. The sensitivity and specificity of procalcitonin for diagnosis of serious bacterial infection were 78% and 80%, respectively. For CRP, the figures were 93% and 76%.
The combination of procalcitonin and CRP outperformed a multitude of other two-, three-, and four-biomarker combinations tested, with an area under the curve of 93% for combined sensitivity and specificity.
The study included 657 children admitted to the pediatric ICU at Alder Hey Children’s Hospital in Liverpool with systemic inflammatory response syndrome. All had blood samples measured for the five biomarkers on days 1-7. Clinicians were blinded as to the biomarker results. Ninety-two (14%) patients were ultimately found to have a serious bacterial infection – essentially, bacterial meningitis or septic shock – and 565 (86%) had a nonbacterial etiology.
The 28-day mortality rate was 9% in the group with serious bacterial infection, significantly higher than the 2% rate in the group with other causes of their systemic inflammatory response syndrome.
Longitudinal trends in procalcitonin and CRP as evidenced in the study can be used in clinical decision making, according to Dr. Carrol. Mean values of procalcitonin plummeted by 80% from day 1 to day 5 in response to antimicrobial therapy in the group with serious bacterial infections. In contrast, CRP levels rose sharply from day 1 to a peak on day 2, then fell, although the 50% drop from day 2 to day 5 in response to antimicrobial therapy wasn’t as pronounced as the change in procalcitonin.
“There is an additive benefit for both biomarkers compared with CRP alone. The problem with CRP on admission, as I’ve demonstrated in this study, is it often hasn’t risen yet early after admission. So although it gave the best area under the curve of any of the biomarkers, I think that combined with procalcitonin you get a much better descriminator,” Dr. Carrol said.
The median duration of ICU stay in the patients with serious bacterial infection at admission was 5 days, compared with 3 days when the cause of systemic inflammatory response syndrome lay elsewhere. Their median duration of ventilation was significantly longer, too: 4 days versus 2 in children without a serious bacterial infection.
Stepwise logistic regression analysis pinpointed several clinical variables as being associated with prolonged ICU stay.
In addition, initiation of antibiotic therapy prior to admission to the pediatric ICU was associated with a 50% reduction in the likelihood of a prolonged ICU stay. “This reflects the fact that early antibiotics give you a better prognosis if you have sepsis,” according to Dr. Carrol.
She and her coinvestigators now have embarked on a multicenter U.K. study looking at the impact of procalcitonin to guide duration of antimicrobial therapy in critically ill children.
The Alder Hey study was funded by the U.K. National Institute for Health Research. Dr. Carrol reported having no financial conflicts. Although she serves as a consultant to several health care companies, all remuneration goes directly to the University of Liverpool.
REPORTING FROM ESPID 2018
Key clinical point:
Major finding: The area under the curve combining sensitivity and specificity was 93%.
Study details: This was a prospective, observational, single-center, clinician-blinded study of 657 patients admitted to a pediatric ICU with symptoms of systemic inflammatory response syndrome.
Disclosures: The study was funded by the U.K. National Institute for Health Research. The presenter reported having no relevant financial conflicts. Although she serves as a consultant to several health care companies, all remuneration goes directly to the University of Liverpool.
Mindfulness skill can help in parenting
Behavioral parent management training (PMT), which teaches parents concrete skills to increase their attention to positive behavior and to plan for their response to undesired behavior, has abundant evidence for success for many challenging child behaviors. But sometimes parents have a hard time managing their own emotional responses in the often highly triggering situation of family conflict. Mindfulness has the potential to provide a complement to the PMT skills. Studies are beginning to explore these possibilities.
Case summary
Zoe is a bright 5-year-old who has been “strong willed” and shown intense emotional responses since early in life. The usual 2-year-old temper tantrums increased over time. She has outbursts of yelling, kicking, and hitting, especially with transitions. Her parents tried behavioral parent training, but found it frustrating. If Zoe has been yelling and hitting earlier in the day, her mother feels hurt and angry and can’t bring herself to pay warm attention when Zoe is doing better. When Zoe refuses to pick up her room, her father is flooded with thoughts about his own father hitting him for the slightest disrespect. He thinks that he is a bad, weak father, and sometimes “sees red” and ends up yelling at Zoe instead of putting into place a calm consequence.
Discussion
Mindfulness is defined by Jon Kabat-Zinn as “paying attention in a particular way – on purpose, in the present moment, and nonjudgmentally.” A central feature of mindfulness is strengthening the ability to focus our attention. We learn to pay attention to aspects of the present moment, be that breathing, the sensations in our body, or the experiences of our senses. Often the first skill in behavioral training methods is getting parents to pay attention to their children by participating in child-led play or spending attentive time with older children. This means attending to what the child is doing or talking about rather than jumping in and taking over with suggestions, instructions, or judgments. This meshes very well with this central aspect of mindfulness.
As we practice paying attention, we observe that the mind naturally jumps around from what we mean to be attending to, to a host of distractions, worries, plans, memories, thoughts, and emotions. Mindfulness encourages practitioners to notice these thoughts, to avoid criticizing or judging oneself for becoming involved with these, but instead gently lead the mind back to what you had intended to focus on. This observation of the mind’s activity gives the mindfulness practitioner a bit of space from the thought or emotion itself. We are encouraged to name the thought or emotional processes we notice: “I am worrying, I am planning, I am remembering.”
In the heat of a difficult moment with the child, parents often are flooded with intense emotions (such as anger, fear, anxiety, panic, despair) and thoughts (such as “If my child keeps acting this way he is going to go to jail when he grows up,” “I am a terrible parent,” “Why is my child doing this to me?” or “He is just like his father”). These emotions and thoughts can drive intense, impulsive responses from the parents. As they practice mindfulness, they can gain the ability to observe themselves having these thoughts; observe harsh judgments of themselves or their children or their partners; have some space from them; and realize they may change in a few minutes or realize they may be painful but don’t necessarily have to spur impulsive action. In that moment, parents can give themselves time and space to think through possible actions, and then choose one.
From a behavioral parenting standpoint, we know that parents and humans often react intensely to negative behaviors and inadvertently make them worse with intense emotional reactivity. We want parents to have a plan about how they will respond, to remain calm in the moment, and then put the plan in place. Mindfulness may enhance parents’ ability to notice their own responses and have the space to remember what the plan was and then put it into place. It also can give them space to consider what the child might be experiencing and respond in light of this awareness. This ability does require a significant amount of mindfulness practice.
The combination of mindfulness and parenting is just beginning to be studied in research trials using a range of study designs. Some of these programs have looked at the effect of mindfulness courses, especially mindfulness-based stress reduction without any specific parenting content or indices of parent stress and child behavior. Others have looked at programs which add mindfulness to standard behavioral parenting programs, and still others are specific mindfulness/parenting programs. So far, many of these studies are quasi-experimental in nature. A recent systematic review by Townshend et al. found seven randomized controlled trials of low to moderate quality with some suggestion of ability to decrease parental stress and ADHD symptoms (JBI Database System Rev Implement Rep. 2016 Mar;14[3]:139-80). There is a clear need for randomized controlled trials with larger sample sizes.
While we may not have specific, highly evidence-based mindful parenting programs available, individuals with experience in yoga, meditation, mindfulness, dialectical behavioral therapy, and acceptance and commitment therapy can be encouraged to bring these skills to bear as parents.
Zoe’s parents had pursued outside mindfulness programs. Mindfulness concepts were brought into a standard parenting program. Her parents were encouraged to engage in child-led play with Zoe in a mindful way, fully attending to her actions and experience. Zoe’s parents also were encouraged to observe their own emotional reactions and thoughts in stressful moments and to take a breathing space before taking action.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].
Resources
“Mindful Parenting” (New York: Norton & Co., 2015).
“Integrating mindfulness with parent training: Effects of the mindfulness-enhanced strengthening families program” (Dev Psychol. 2015;51[1]:26-35).
“Everyday blessings: The inner work of mindful parenting,” (New York: Hyperion, 1997).
Behavioral parent management training (PMT), which teaches parents concrete skills to increase their attention to positive behavior and to plan for their response to undesired behavior, has abundant evidence for success for many challenging child behaviors. But sometimes parents have a hard time managing their own emotional responses in the often highly triggering situation of family conflict. Mindfulness has the potential to provide a complement to the PMT skills. Studies are beginning to explore these possibilities.
Case summary
Zoe is a bright 5-year-old who has been “strong willed” and shown intense emotional responses since early in life. The usual 2-year-old temper tantrums increased over time. She has outbursts of yelling, kicking, and hitting, especially with transitions. Her parents tried behavioral parent training, but found it frustrating. If Zoe has been yelling and hitting earlier in the day, her mother feels hurt and angry and can’t bring herself to pay warm attention when Zoe is doing better. When Zoe refuses to pick up her room, her father is flooded with thoughts about his own father hitting him for the slightest disrespect. He thinks that he is a bad, weak father, and sometimes “sees red” and ends up yelling at Zoe instead of putting into place a calm consequence.
Discussion
Mindfulness is defined by Jon Kabat-Zinn as “paying attention in a particular way – on purpose, in the present moment, and nonjudgmentally.” A central feature of mindfulness is strengthening the ability to focus our attention. We learn to pay attention to aspects of the present moment, be that breathing, the sensations in our body, or the experiences of our senses. Often the first skill in behavioral training methods is getting parents to pay attention to their children by participating in child-led play or spending attentive time with older children. This means attending to what the child is doing or talking about rather than jumping in and taking over with suggestions, instructions, or judgments. This meshes very well with this central aspect of mindfulness.
As we practice paying attention, we observe that the mind naturally jumps around from what we mean to be attending to, to a host of distractions, worries, plans, memories, thoughts, and emotions. Mindfulness encourages practitioners to notice these thoughts, to avoid criticizing or judging oneself for becoming involved with these, but instead gently lead the mind back to what you had intended to focus on. This observation of the mind’s activity gives the mindfulness practitioner a bit of space from the thought or emotion itself. We are encouraged to name the thought or emotional processes we notice: “I am worrying, I am planning, I am remembering.”
In the heat of a difficult moment with the child, parents often are flooded with intense emotions (such as anger, fear, anxiety, panic, despair) and thoughts (such as “If my child keeps acting this way he is going to go to jail when he grows up,” “I am a terrible parent,” “Why is my child doing this to me?” or “He is just like his father”). These emotions and thoughts can drive intense, impulsive responses from the parents. As they practice mindfulness, they can gain the ability to observe themselves having these thoughts; observe harsh judgments of themselves or their children or their partners; have some space from them; and realize they may change in a few minutes or realize they may be painful but don’t necessarily have to spur impulsive action. In that moment, parents can give themselves time and space to think through possible actions, and then choose one.
From a behavioral parenting standpoint, we know that parents and humans often react intensely to negative behaviors and inadvertently make them worse with intense emotional reactivity. We want parents to have a plan about how they will respond, to remain calm in the moment, and then put the plan in place. Mindfulness may enhance parents’ ability to notice their own responses and have the space to remember what the plan was and then put it into place. It also can give them space to consider what the child might be experiencing and respond in light of this awareness. This ability does require a significant amount of mindfulness practice.
The combination of mindfulness and parenting is just beginning to be studied in research trials using a range of study designs. Some of these programs have looked at the effect of mindfulness courses, especially mindfulness-based stress reduction without any specific parenting content or indices of parent stress and child behavior. Others have looked at programs which add mindfulness to standard behavioral parenting programs, and still others are specific mindfulness/parenting programs. So far, many of these studies are quasi-experimental in nature. A recent systematic review by Townshend et al. found seven randomized controlled trials of low to moderate quality with some suggestion of ability to decrease parental stress and ADHD symptoms (JBI Database System Rev Implement Rep. 2016 Mar;14[3]:139-80). There is a clear need for randomized controlled trials with larger sample sizes.
While we may not have specific, highly evidence-based mindful parenting programs available, individuals with experience in yoga, meditation, mindfulness, dialectical behavioral therapy, and acceptance and commitment therapy can be encouraged to bring these skills to bear as parents.
Zoe’s parents had pursued outside mindfulness programs. Mindfulness concepts were brought into a standard parenting program. Her parents were encouraged to engage in child-led play with Zoe in a mindful way, fully attending to her actions and experience. Zoe’s parents also were encouraged to observe their own emotional reactions and thoughts in stressful moments and to take a breathing space before taking action.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].
Resources
“Mindful Parenting” (New York: Norton & Co., 2015).
“Integrating mindfulness with parent training: Effects of the mindfulness-enhanced strengthening families program” (Dev Psychol. 2015;51[1]:26-35).
“Everyday blessings: The inner work of mindful parenting,” (New York: Hyperion, 1997).
Behavioral parent management training (PMT), which teaches parents concrete skills to increase their attention to positive behavior and to plan for their response to undesired behavior, has abundant evidence for success for many challenging child behaviors. But sometimes parents have a hard time managing their own emotional responses in the often highly triggering situation of family conflict. Mindfulness has the potential to provide a complement to the PMT skills. Studies are beginning to explore these possibilities.
Case summary
Zoe is a bright 5-year-old who has been “strong willed” and shown intense emotional responses since early in life. The usual 2-year-old temper tantrums increased over time. She has outbursts of yelling, kicking, and hitting, especially with transitions. Her parents tried behavioral parent training, but found it frustrating. If Zoe has been yelling and hitting earlier in the day, her mother feels hurt and angry and can’t bring herself to pay warm attention when Zoe is doing better. When Zoe refuses to pick up her room, her father is flooded with thoughts about his own father hitting him for the slightest disrespect. He thinks that he is a bad, weak father, and sometimes “sees red” and ends up yelling at Zoe instead of putting into place a calm consequence.
Discussion
Mindfulness is defined by Jon Kabat-Zinn as “paying attention in a particular way – on purpose, in the present moment, and nonjudgmentally.” A central feature of mindfulness is strengthening the ability to focus our attention. We learn to pay attention to aspects of the present moment, be that breathing, the sensations in our body, or the experiences of our senses. Often the first skill in behavioral training methods is getting parents to pay attention to their children by participating in child-led play or spending attentive time with older children. This means attending to what the child is doing or talking about rather than jumping in and taking over with suggestions, instructions, or judgments. This meshes very well with this central aspect of mindfulness.
As we practice paying attention, we observe that the mind naturally jumps around from what we mean to be attending to, to a host of distractions, worries, plans, memories, thoughts, and emotions. Mindfulness encourages practitioners to notice these thoughts, to avoid criticizing or judging oneself for becoming involved with these, but instead gently lead the mind back to what you had intended to focus on. This observation of the mind’s activity gives the mindfulness practitioner a bit of space from the thought or emotion itself. We are encouraged to name the thought or emotional processes we notice: “I am worrying, I am planning, I am remembering.”
In the heat of a difficult moment with the child, parents often are flooded with intense emotions (such as anger, fear, anxiety, panic, despair) and thoughts (such as “If my child keeps acting this way he is going to go to jail when he grows up,” “I am a terrible parent,” “Why is my child doing this to me?” or “He is just like his father”). These emotions and thoughts can drive intense, impulsive responses from the parents. As they practice mindfulness, they can gain the ability to observe themselves having these thoughts; observe harsh judgments of themselves or their children or their partners; have some space from them; and realize they may change in a few minutes or realize they may be painful but don’t necessarily have to spur impulsive action. In that moment, parents can give themselves time and space to think through possible actions, and then choose one.
From a behavioral parenting standpoint, we know that parents and humans often react intensely to negative behaviors and inadvertently make them worse with intense emotional reactivity. We want parents to have a plan about how they will respond, to remain calm in the moment, and then put the plan in place. Mindfulness may enhance parents’ ability to notice their own responses and have the space to remember what the plan was and then put it into place. It also can give them space to consider what the child might be experiencing and respond in light of this awareness. This ability does require a significant amount of mindfulness practice.
The combination of mindfulness and parenting is just beginning to be studied in research trials using a range of study designs. Some of these programs have looked at the effect of mindfulness courses, especially mindfulness-based stress reduction without any specific parenting content or indices of parent stress and child behavior. Others have looked at programs which add mindfulness to standard behavioral parenting programs, and still others are specific mindfulness/parenting programs. So far, many of these studies are quasi-experimental in nature. A recent systematic review by Townshend et al. found seven randomized controlled trials of low to moderate quality with some suggestion of ability to decrease parental stress and ADHD symptoms (JBI Database System Rev Implement Rep. 2016 Mar;14[3]:139-80). There is a clear need for randomized controlled trials with larger sample sizes.
While we may not have specific, highly evidence-based mindful parenting programs available, individuals with experience in yoga, meditation, mindfulness, dialectical behavioral therapy, and acceptance and commitment therapy can be encouraged to bring these skills to bear as parents.
Zoe’s parents had pursued outside mindfulness programs. Mindfulness concepts were brought into a standard parenting program. Her parents were encouraged to engage in child-led play with Zoe in a mindful way, fully attending to her actions and experience. Zoe’s parents also were encouraged to observe their own emotional reactions and thoughts in stressful moments and to take a breathing space before taking action.
Dr. Hall is assistant professor of psychiatry and pediatrics at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].
Resources
“Mindful Parenting” (New York: Norton & Co., 2015).
“Integrating mindfulness with parent training: Effects of the mindfulness-enhanced strengthening families program” (Dev Psychol. 2015;51[1]:26-35).
“Everyday blessings: The inner work of mindful parenting,” (New York: Hyperion, 1997).
Pediatric Dermatology Consult - July 2018
Frequently misdiagnosed, streptococcal intertrigo more commonly affects infants and toddlers but is rarely reported, especially compared with other Streptococcus pyogenes infections, including impetigo, erysipelas, and cellulitis.1
Intertrigo, meaning “between” (inter) and “to rub” (terere) in Latin, describes any skin disorder involving two opposing skin surfaces that touch or rub to cause friction.2 The continuous chaffing, coupled with moisture trapped within the skin folds, leads to irritation and maceration, which provides an ideal environment for pathogens to thrive. Thus, frictional dermatitides that arise may become secondarily infected with one or more microorganisms, such as Candida albicans, Staphylococcus aureus, Streptococcus pyogenes, and even organisms less commonly associated with cutaneous infection, such as Proteus mirabilis.3
Streptococcal intertrigo may affect any intertriginous area, but most commonly it affects the folds of the neck; this is likely because of the combination of the deep folds that develop in shorter, infantile necks and the moisture from drool and saliva that pools in the area.5,6 In addition to these cervical folds, other intertriginous areas commonly are affected, including the inguinal, axillary, popliteal, posterior auricular, perianal, and genital folds.
Perianal streptococcal disease may present in a similar manner as streptococcal intertrigo, manifesting as well-demarcated, beefy red plaques in the skin folds around the anus and, in females, frequently perivaginally.7 Unlike streptococcal intertrigo, perianal streptococcal disease is often characterized by pain, pruritus, and fissuring of the involved area.8 It is associated with pharyngeal colonization of group A beta-hemolytic streptococci.7
Diagnosis is straight forward and may be confirmed by a positive streptococcal rapid antigen test of swab specimens of one or more surfaces of affected skin or by culture from a skin swab yielding growth of the organism.1,5 Skin biopsy is not necessary. If the index of suspicion for candida is high, a potassium hydroxide preparation and culture may be performed. Checking serum anti-DNase B antibodies, antistreptolysin O, and pharyngeal cultures is often unrevealing.9 A urinalysis may be performed to assess for poststreptococcal glomerulonephritis if the patient later develops facial or orbital edema, hypertension, hematuria, or lethargy.9
Treatment consists of systemic antistreptococcal therapy; oral amoxicillin and penicillin frequently have been used.9 Moisture in the area should be reduced with application of absorptive powders and physical barriers, such as zinc oxide, after gentle cleansing of the area.5
Other diagnoses to consider when evaluating dermatitides affecting skin folds include: other infectious causes, which may be ruled out by fungal or bacterial culture; inverse psoriasis, which will frequently demonstrate scale; atopic dermatitis, which will be pruritic with history of atopy; irritant or contact dermatitis, which will often have correlating clinical history; seborrheic dermatitis, which will often involve greasiness and scale; and less commonly, acrodermatitis enteropathica, which will be accompanied by diarrhea and hair loss.2,9 Scabies also may be on the differential if the patient endorses severe pruritus with close contacts with similar symptoms.
Ms. Han is a medical student at the University of California, San Diego. Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego. He is vice chair of the department of dermatology and a professor of dermatology and pediatrics at the university. They had no conflicts of interest or disclosures to report.
References
1. Pediatr Dermatol. 2014 Mar-Apr;31(2):e71-2.
2. Clin Dermatol. 2011 Mar-Apr;29(2):173-9.
3. Pediatrics. 2003 Dec;112(6 pt 1):1427-9.
4. BMJ Case Rep. 2018 Mar 20. doi: 10.1136/bcr-2018-224179.
5. Pediatr Infect Dis J. 2012 Aug;31(8):872-3.
6. J Pediatr. 2015 May;166(5):1318.
7. J Pediatr. 2015 Sep;167(3):687-93.e1-2.
8. Pediatrics in Review. 1991;12(8):248-55.
9. J Pediatr. 2017 May;184:230-1.e1.
Frequently misdiagnosed, streptococcal intertrigo more commonly affects infants and toddlers but is rarely reported, especially compared with other Streptococcus pyogenes infections, including impetigo, erysipelas, and cellulitis.1
Intertrigo, meaning “between” (inter) and “to rub” (terere) in Latin, describes any skin disorder involving two opposing skin surfaces that touch or rub to cause friction.2 The continuous chaffing, coupled with moisture trapped within the skin folds, leads to irritation and maceration, which provides an ideal environment for pathogens to thrive. Thus, frictional dermatitides that arise may become secondarily infected with one or more microorganisms, such as Candida albicans, Staphylococcus aureus, Streptococcus pyogenes, and even organisms less commonly associated with cutaneous infection, such as Proteus mirabilis.3
Streptococcal intertrigo may affect any intertriginous area, but most commonly it affects the folds of the neck; this is likely because of the combination of the deep folds that develop in shorter, infantile necks and the moisture from drool and saliva that pools in the area.5,6 In addition to these cervical folds, other intertriginous areas commonly are affected, including the inguinal, axillary, popliteal, posterior auricular, perianal, and genital folds.
Perianal streptococcal disease may present in a similar manner as streptococcal intertrigo, manifesting as well-demarcated, beefy red plaques in the skin folds around the anus and, in females, frequently perivaginally.7 Unlike streptococcal intertrigo, perianal streptococcal disease is often characterized by pain, pruritus, and fissuring of the involved area.8 It is associated with pharyngeal colonization of group A beta-hemolytic streptococci.7
Diagnosis is straight forward and may be confirmed by a positive streptococcal rapid antigen test of swab specimens of one or more surfaces of affected skin or by culture from a skin swab yielding growth of the organism.1,5 Skin biopsy is not necessary. If the index of suspicion for candida is high, a potassium hydroxide preparation and culture may be performed. Checking serum anti-DNase B antibodies, antistreptolysin O, and pharyngeal cultures is often unrevealing.9 A urinalysis may be performed to assess for poststreptococcal glomerulonephritis if the patient later develops facial or orbital edema, hypertension, hematuria, or lethargy.9
Treatment consists of systemic antistreptococcal therapy; oral amoxicillin and penicillin frequently have been used.9 Moisture in the area should be reduced with application of absorptive powders and physical barriers, such as zinc oxide, after gentle cleansing of the area.5
Other diagnoses to consider when evaluating dermatitides affecting skin folds include: other infectious causes, which may be ruled out by fungal or bacterial culture; inverse psoriasis, which will frequently demonstrate scale; atopic dermatitis, which will be pruritic with history of atopy; irritant or contact dermatitis, which will often have correlating clinical history; seborrheic dermatitis, which will often involve greasiness and scale; and less commonly, acrodermatitis enteropathica, which will be accompanied by diarrhea and hair loss.2,9 Scabies also may be on the differential if the patient endorses severe pruritus with close contacts with similar symptoms.
Ms. Han is a medical student at the University of California, San Diego. Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego. He is vice chair of the department of dermatology and a professor of dermatology and pediatrics at the university. They had no conflicts of interest or disclosures to report.
References
1. Pediatr Dermatol. 2014 Mar-Apr;31(2):e71-2.
2. Clin Dermatol. 2011 Mar-Apr;29(2):173-9.
3. Pediatrics. 2003 Dec;112(6 pt 1):1427-9.
4. BMJ Case Rep. 2018 Mar 20. doi: 10.1136/bcr-2018-224179.
5. Pediatr Infect Dis J. 2012 Aug;31(8):872-3.
6. J Pediatr. 2015 May;166(5):1318.
7. J Pediatr. 2015 Sep;167(3):687-93.e1-2.
8. Pediatrics in Review. 1991;12(8):248-55.
9. J Pediatr. 2017 May;184:230-1.e1.
Frequently misdiagnosed, streptococcal intertrigo more commonly affects infants and toddlers but is rarely reported, especially compared with other Streptococcus pyogenes infections, including impetigo, erysipelas, and cellulitis.1
Intertrigo, meaning “between” (inter) and “to rub” (terere) in Latin, describes any skin disorder involving two opposing skin surfaces that touch or rub to cause friction.2 The continuous chaffing, coupled with moisture trapped within the skin folds, leads to irritation and maceration, which provides an ideal environment for pathogens to thrive. Thus, frictional dermatitides that arise may become secondarily infected with one or more microorganisms, such as Candida albicans, Staphylococcus aureus, Streptococcus pyogenes, and even organisms less commonly associated with cutaneous infection, such as Proteus mirabilis.3
Streptococcal intertrigo may affect any intertriginous area, but most commonly it affects the folds of the neck; this is likely because of the combination of the deep folds that develop in shorter, infantile necks and the moisture from drool and saliva that pools in the area.5,6 In addition to these cervical folds, other intertriginous areas commonly are affected, including the inguinal, axillary, popliteal, posterior auricular, perianal, and genital folds.
Perianal streptococcal disease may present in a similar manner as streptococcal intertrigo, manifesting as well-demarcated, beefy red plaques in the skin folds around the anus and, in females, frequently perivaginally.7 Unlike streptococcal intertrigo, perianal streptococcal disease is often characterized by pain, pruritus, and fissuring of the involved area.8 It is associated with pharyngeal colonization of group A beta-hemolytic streptococci.7
Diagnosis is straight forward and may be confirmed by a positive streptococcal rapid antigen test of swab specimens of one or more surfaces of affected skin or by culture from a skin swab yielding growth of the organism.1,5 Skin biopsy is not necessary. If the index of suspicion for candida is high, a potassium hydroxide preparation and culture may be performed. Checking serum anti-DNase B antibodies, antistreptolysin O, and pharyngeal cultures is often unrevealing.9 A urinalysis may be performed to assess for poststreptococcal glomerulonephritis if the patient later develops facial or orbital edema, hypertension, hematuria, or lethargy.9
Treatment consists of systemic antistreptococcal therapy; oral amoxicillin and penicillin frequently have been used.9 Moisture in the area should be reduced with application of absorptive powders and physical barriers, such as zinc oxide, after gentle cleansing of the area.5
Other diagnoses to consider when evaluating dermatitides affecting skin folds include: other infectious causes, which may be ruled out by fungal or bacterial culture; inverse psoriasis, which will frequently demonstrate scale; atopic dermatitis, which will be pruritic with history of atopy; irritant or contact dermatitis, which will often have correlating clinical history; seborrheic dermatitis, which will often involve greasiness and scale; and less commonly, acrodermatitis enteropathica, which will be accompanied by diarrhea and hair loss.2,9 Scabies also may be on the differential if the patient endorses severe pruritus with close contacts with similar symptoms.
Ms. Han is a medical student at the University of California, San Diego. Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego. He is vice chair of the department of dermatology and a professor of dermatology and pediatrics at the university. They had no conflicts of interest or disclosures to report.
References
1. Pediatr Dermatol. 2014 Mar-Apr;31(2):e71-2.
2. Clin Dermatol. 2011 Mar-Apr;29(2):173-9.
3. Pediatrics. 2003 Dec;112(6 pt 1):1427-9.
4. BMJ Case Rep. 2018 Mar 20. doi: 10.1136/bcr-2018-224179.
5. Pediatr Infect Dis J. 2012 Aug;31(8):872-3.
6. J Pediatr. 2015 May;166(5):1318.
7. J Pediatr. 2015 Sep;167(3):687-93.e1-2.
8. Pediatrics in Review. 1991;12(8):248-55.
9. J Pediatr. 2017 May;184:230-1.e1.
An 8-week-old male with a history of cradle cap presented for a second evaluation of an erythematous rash on the neck that started 1.5 weeks before, and it had since worsened. The parents note that their infant has been more irritable, but they otherwise deny any fever, diarrhea, constipation, or decrease in oral intake.
The patient’s first evaluation had been 3 days prior; nystatin cream was prescribed, and the parents applied it twice a day but without improvement to the rash. The patient also had a rash behind the ears bilaterally, which was treated with hydrocortisone 2.5% ointment with some improvement
On physical exam, the central neck is covered by a bright, beefy red, erythematous plaque with distinct borders and strong odor. There is faint scale and superficial desquamation between the skin folds. There are no surrounding papules or pustules. The patient’s chin is moist with drool. In the postauricular skin folds bilaterally, there are fainter but still erythematous plaques with mild scale.
Serum troponin predicts cardiovascular death in early arthritis
LIVERPOOL, ENGLAND – Serum levels of the cardiac biomarker troponin might prove useful for assessing the risk of death from cardiovascular causes in patients with inflammatory arthritis, according to study findings presented at the British Society for Rheumatology annual conference.
“In this analysis we have shown that baseline troponin levels predict cardiovascular death in inflammatory arthritis, and this association is independent of the traditional risk factors, inflammation, and disease characteristics at baseline,” said study author Sarah Skeoch, MBChB, who works at the Arthritis Research UK Centre for Epidemiology in the division of musculoskeletal and dermatological sciences at the University of Manchester (England).
Furthermore, the association remained in patients who had rheumatoid arthritis classified according to the 2010 American College of Rheumatology and European League Against Rheumatism criteria (overall adjusted HR, 2.25) and in those without prior cardiovascular disease at baseline (HR, 1.63).
Individuals with inflammatory arthritis are known to have an increased risk of developing cardiovascular problems versus the general population, but current prediction models using traditional risk factors do not fully account for the increased risk seen in patients with inflammatory arthritis, Dr. Skeoch explained.
“There has been some work looking at troponin in inflammatory arthritis already,” she said, with “higher levels observed versus age- and sex-matched controls, and associations have been shown with traditional risk factors.” There has also been a link to C-reactive protein levels and disease activity, and there has also been an association with coronary stenosis on CT scans. The aim of the current study was to see if there was any link to cardiovascular events and death.
A total of 1,023 patients who had been recruited into NOAR between 2000 and 2009 were studied. NOAR is an inception cohort study that includes patients with a history of two or more swollen joints for 4 weeks or more and has been running for almost 30 years. At baseline serum samples are taken and a variety of assessments made, including cardiovascular risk factors.
The study population was mostly female (66%), aged a median of 56 years, and had symptoms for a median of 10.6 months. Around half were seropositive for rheumatoid factor, anti–citrullinated protein antibodies, or both. The median baseline disease activity score in 28 joints (DAS28) was 3.73, and 61% met ACR/EULAR 2010 criteria for RA.
Baseline serum samples were analyzed using a chemiluminescent assay to determine hs-TnI levels, with the median being 6.3 pg/mL. All patients had detectable hs-TnI levels, and 2.6% had levels exceeding 26.1 pg/mL, which is the level associated with having had an acute myocardial infarction. Almost 4% had a previous cardiovascular event, and 7% had diabetes. One in five were current smokers, and roughly 18% had hypertension. The investigators adjusted for all of these factors in the multivariate analyses.
The median follow up was 11.2 years, totaling 11,237 person-years, and during that time 158 deaths occurred, of which 27 were due to ischemic events. The median time from inclusion in NOAR to death was 7.4 years.
When levels of hs-TnI were separated into tertiles, a 12.5-fold increased risk was observed when comparing patients in the highest (more than 7.7 pg/mL) to lowest tertiles (less than 5.2 pg/mL).
“The magnitude of risk between the highest and the lowest tertile was much greater than observed in the general population,” Dr. Skeoch said, and although not directly comparable, she said the hazard ratios were 12.5 and 1.67, “which again suggests that troponin may be an effective tool or addition to the risk prediction models in inflammatory arthritis.”
Unlike some biomarkers, assays to assess troponin are already available in the clinic, Dr. Skeoch commented, “so if further work by us and other groups do suggest a role for troponin, this could be translated fairly rapidly into clinical practice.”
Further research needs to look at why troponin is raised and what is its relationship to other risk factors. “There is a strong association with traditional risk factors such as lipids, so it would stand to reason that managing those risk factors, as well as lifestyle factors, would have a positive impact,” Dr. Skeoch suggested.
The NOAR register is funded by Arthritis Research UK and the U.K. National Institute for Health Research. Dr. Skeoch and her coauthors had no relevant financial conflicts of interest.
SOURCE: Skeoch S et al. BSR 2018. Rheumatology. 2018;57[Suppl. 3]:key075.192.
LIVERPOOL, ENGLAND – Serum levels of the cardiac biomarker troponin might prove useful for assessing the risk of death from cardiovascular causes in patients with inflammatory arthritis, according to study findings presented at the British Society for Rheumatology annual conference.
“In this analysis we have shown that baseline troponin levels predict cardiovascular death in inflammatory arthritis, and this association is independent of the traditional risk factors, inflammation, and disease characteristics at baseline,” said study author Sarah Skeoch, MBChB, who works at the Arthritis Research UK Centre for Epidemiology in the division of musculoskeletal and dermatological sciences at the University of Manchester (England).
Furthermore, the association remained in patients who had rheumatoid arthritis classified according to the 2010 American College of Rheumatology and European League Against Rheumatism criteria (overall adjusted HR, 2.25) and in those without prior cardiovascular disease at baseline (HR, 1.63).
Individuals with inflammatory arthritis are known to have an increased risk of developing cardiovascular problems versus the general population, but current prediction models using traditional risk factors do not fully account for the increased risk seen in patients with inflammatory arthritis, Dr. Skeoch explained.
“There has been some work looking at troponin in inflammatory arthritis already,” she said, with “higher levels observed versus age- and sex-matched controls, and associations have been shown with traditional risk factors.” There has also been a link to C-reactive protein levels and disease activity, and there has also been an association with coronary stenosis on CT scans. The aim of the current study was to see if there was any link to cardiovascular events and death.
A total of 1,023 patients who had been recruited into NOAR between 2000 and 2009 were studied. NOAR is an inception cohort study that includes patients with a history of two or more swollen joints for 4 weeks or more and has been running for almost 30 years. At baseline serum samples are taken and a variety of assessments made, including cardiovascular risk factors.
The study population was mostly female (66%), aged a median of 56 years, and had symptoms for a median of 10.6 months. Around half were seropositive for rheumatoid factor, anti–citrullinated protein antibodies, or both. The median baseline disease activity score in 28 joints (DAS28) was 3.73, and 61% met ACR/EULAR 2010 criteria for RA.
Baseline serum samples were analyzed using a chemiluminescent assay to determine hs-TnI levels, with the median being 6.3 pg/mL. All patients had detectable hs-TnI levels, and 2.6% had levels exceeding 26.1 pg/mL, which is the level associated with having had an acute myocardial infarction. Almost 4% had a previous cardiovascular event, and 7% had diabetes. One in five were current smokers, and roughly 18% had hypertension. The investigators adjusted for all of these factors in the multivariate analyses.
The median follow up was 11.2 years, totaling 11,237 person-years, and during that time 158 deaths occurred, of which 27 were due to ischemic events. The median time from inclusion in NOAR to death was 7.4 years.
When levels of hs-TnI were separated into tertiles, a 12.5-fold increased risk was observed when comparing patients in the highest (more than 7.7 pg/mL) to lowest tertiles (less than 5.2 pg/mL).
“The magnitude of risk between the highest and the lowest tertile was much greater than observed in the general population,” Dr. Skeoch said, and although not directly comparable, she said the hazard ratios were 12.5 and 1.67, “which again suggests that troponin may be an effective tool or addition to the risk prediction models in inflammatory arthritis.”
Unlike some biomarkers, assays to assess troponin are already available in the clinic, Dr. Skeoch commented, “so if further work by us and other groups do suggest a role for troponin, this could be translated fairly rapidly into clinical practice.”
Further research needs to look at why troponin is raised and what is its relationship to other risk factors. “There is a strong association with traditional risk factors such as lipids, so it would stand to reason that managing those risk factors, as well as lifestyle factors, would have a positive impact,” Dr. Skeoch suggested.
The NOAR register is funded by Arthritis Research UK and the U.K. National Institute for Health Research. Dr. Skeoch and her coauthors had no relevant financial conflicts of interest.
SOURCE: Skeoch S et al. BSR 2018. Rheumatology. 2018;57[Suppl. 3]:key075.192.
LIVERPOOL, ENGLAND – Serum levels of the cardiac biomarker troponin might prove useful for assessing the risk of death from cardiovascular causes in patients with inflammatory arthritis, according to study findings presented at the British Society for Rheumatology annual conference.
“In this analysis we have shown that baseline troponin levels predict cardiovascular death in inflammatory arthritis, and this association is independent of the traditional risk factors, inflammation, and disease characteristics at baseline,” said study author Sarah Skeoch, MBChB, who works at the Arthritis Research UK Centre for Epidemiology in the division of musculoskeletal and dermatological sciences at the University of Manchester (England).
Furthermore, the association remained in patients who had rheumatoid arthritis classified according to the 2010 American College of Rheumatology and European League Against Rheumatism criteria (overall adjusted HR, 2.25) and in those without prior cardiovascular disease at baseline (HR, 1.63).
Individuals with inflammatory arthritis are known to have an increased risk of developing cardiovascular problems versus the general population, but current prediction models using traditional risk factors do not fully account for the increased risk seen in patients with inflammatory arthritis, Dr. Skeoch explained.
“There has been some work looking at troponin in inflammatory arthritis already,” she said, with “higher levels observed versus age- and sex-matched controls, and associations have been shown with traditional risk factors.” There has also been a link to C-reactive protein levels and disease activity, and there has also been an association with coronary stenosis on CT scans. The aim of the current study was to see if there was any link to cardiovascular events and death.
A total of 1,023 patients who had been recruited into NOAR between 2000 and 2009 were studied. NOAR is an inception cohort study that includes patients with a history of two or more swollen joints for 4 weeks or more and has been running for almost 30 years. At baseline serum samples are taken and a variety of assessments made, including cardiovascular risk factors.
The study population was mostly female (66%), aged a median of 56 years, and had symptoms for a median of 10.6 months. Around half were seropositive for rheumatoid factor, anti–citrullinated protein antibodies, or both. The median baseline disease activity score in 28 joints (DAS28) was 3.73, and 61% met ACR/EULAR 2010 criteria for RA.
Baseline serum samples were analyzed using a chemiluminescent assay to determine hs-TnI levels, with the median being 6.3 pg/mL. All patients had detectable hs-TnI levels, and 2.6% had levels exceeding 26.1 pg/mL, which is the level associated with having had an acute myocardial infarction. Almost 4% had a previous cardiovascular event, and 7% had diabetes. One in five were current smokers, and roughly 18% had hypertension. The investigators adjusted for all of these factors in the multivariate analyses.
The median follow up was 11.2 years, totaling 11,237 person-years, and during that time 158 deaths occurred, of which 27 were due to ischemic events. The median time from inclusion in NOAR to death was 7.4 years.
When levels of hs-TnI were separated into tertiles, a 12.5-fold increased risk was observed when comparing patients in the highest (more than 7.7 pg/mL) to lowest tertiles (less than 5.2 pg/mL).
“The magnitude of risk between the highest and the lowest tertile was much greater than observed in the general population,” Dr. Skeoch said, and although not directly comparable, she said the hazard ratios were 12.5 and 1.67, “which again suggests that troponin may be an effective tool or addition to the risk prediction models in inflammatory arthritis.”
Unlike some biomarkers, assays to assess troponin are already available in the clinic, Dr. Skeoch commented, “so if further work by us and other groups do suggest a role for troponin, this could be translated fairly rapidly into clinical practice.”
Further research needs to look at why troponin is raised and what is its relationship to other risk factors. “There is a strong association with traditional risk factors such as lipids, so it would stand to reason that managing those risk factors, as well as lifestyle factors, would have a positive impact,” Dr. Skeoch suggested.
The NOAR register is funded by Arthritis Research UK and the U.K. National Institute for Health Research. Dr. Skeoch and her coauthors had no relevant financial conflicts of interest.
SOURCE: Skeoch S et al. BSR 2018. Rheumatology. 2018;57[Suppl. 3]:key075.192.
REPORTING FROM BSR 2018
Key clinical point: Cardiovascular mortality was predicted by baseline levels of high-sensitivity troponin I.
Major finding: For every log unit increase in hs-TnI at baseline, there was an increase in cardiovascular mortality (HR, 2.16).
Study details: Analysis of data on 1,023 patients with inflammatory arthritis listed in the Norfolk Arthritis Register.
Disclosures: Dr. Skeoch and coauthors had no relevant financial conflicts of interest.
Source: Skeoch S et al. BSR 2018. Rheumatology. 2018;57[Suppl. 3]:key075.192.
Tralokinumab appears safe and effective for atopic dermatitis, in phase 2b study
Treatment with symptoms in patients with moderate to severe atopic dermatitis (AD), in a recent phase 2b study published in the Journal of Allergy and Clinical Immunology.
The randomized, double-blind, placebo-controlled, dose-ranging study assigned 204 patients to receive placebo or 45 mg, 150 mg, or 300 mg of tralokinumab administered subcutaneously every second week for 12 weeks. The groups had similar demographics and disease characteristics. The patients were aged 15-75 years and had Eczema Area and Severity Index (EASI) scores of 12 or more and an Investigator Global Assessment (IGA) score of 3 or higher. The coprimary endpoints were change in EASI from baseline to week 12 and the percentage of patients with either 0 (clear) or 1 (almost clear) on the IGA scale.
The higher dosages of tralokinumab showed the greatest adjusted mean differences in EASI scores: reductions of 4.36 for the 150-mg group (P = .03) and 4.94 for the 300-mg group (P = .01), compared with placebo. The changes in the 300-mg group were apparent as early as 4 weeks into treatment and were maintained beyond the 12-week mark. The greatest differences, compared with placebo, in IGA were seen in the 300-mg group as well.
Furthermore, patients who had high levels of biomarkers associated with IL-13 showed greater improvements than those seen in the intention-to-treat population at large. By week 12, patient-reported pruritus was also improved, and there were improvements in Dermatology Quality of Life Index (which did not persist past 12 weeks).
Most treatment-emergent adverse events were considered only mild or moderate, and the few more serious events were deemed unrelated to the study drug. The most common adverse events were upper respiratory infections and headaches.
“Participants entering the study had not achieved an adequate response to stable topical glucocorticoids during the 2-week run-in period and, therefore, represent a population with moderate to severe AD and major unmet treatment needs,” the investigators wrote. “The clinically meaningful benefits observed by combining tralokinumab treatment with topical glucocorticoids suggests that tralokinumab could demonstrate improvements in participants whose symptoms cannot be effectively controlled by topical glucocorticoids alone.”
The study was funded by MedImmune, a member of the AstraZeneca Group. Five authors were or are employees of the company; the three remaining authors had disclosures related to numerous pharmaceutical companies, including two with disclosures that included MedImmune.
SOURCE: Wollenberg A et al. J Allergy Clin Immunol. 2018 Jun 12. doi: 10.1016/j.jaci.2018.05.029.
Treatment with symptoms in patients with moderate to severe atopic dermatitis (AD), in a recent phase 2b study published in the Journal of Allergy and Clinical Immunology.
The randomized, double-blind, placebo-controlled, dose-ranging study assigned 204 patients to receive placebo or 45 mg, 150 mg, or 300 mg of tralokinumab administered subcutaneously every second week for 12 weeks. The groups had similar demographics and disease characteristics. The patients were aged 15-75 years and had Eczema Area and Severity Index (EASI) scores of 12 or more and an Investigator Global Assessment (IGA) score of 3 or higher. The coprimary endpoints were change in EASI from baseline to week 12 and the percentage of patients with either 0 (clear) or 1 (almost clear) on the IGA scale.
The higher dosages of tralokinumab showed the greatest adjusted mean differences in EASI scores: reductions of 4.36 for the 150-mg group (P = .03) and 4.94 for the 300-mg group (P = .01), compared with placebo. The changes in the 300-mg group were apparent as early as 4 weeks into treatment and were maintained beyond the 12-week mark. The greatest differences, compared with placebo, in IGA were seen in the 300-mg group as well.
Furthermore, patients who had high levels of biomarkers associated with IL-13 showed greater improvements than those seen in the intention-to-treat population at large. By week 12, patient-reported pruritus was also improved, and there were improvements in Dermatology Quality of Life Index (which did not persist past 12 weeks).
Most treatment-emergent adverse events were considered only mild or moderate, and the few more serious events were deemed unrelated to the study drug. The most common adverse events were upper respiratory infections and headaches.
“Participants entering the study had not achieved an adequate response to stable topical glucocorticoids during the 2-week run-in period and, therefore, represent a population with moderate to severe AD and major unmet treatment needs,” the investigators wrote. “The clinically meaningful benefits observed by combining tralokinumab treatment with topical glucocorticoids suggests that tralokinumab could demonstrate improvements in participants whose symptoms cannot be effectively controlled by topical glucocorticoids alone.”
The study was funded by MedImmune, a member of the AstraZeneca Group. Five authors were or are employees of the company; the three remaining authors had disclosures related to numerous pharmaceutical companies, including two with disclosures that included MedImmune.
SOURCE: Wollenberg A et al. J Allergy Clin Immunol. 2018 Jun 12. doi: 10.1016/j.jaci.2018.05.029.
Treatment with symptoms in patients with moderate to severe atopic dermatitis (AD), in a recent phase 2b study published in the Journal of Allergy and Clinical Immunology.
The randomized, double-blind, placebo-controlled, dose-ranging study assigned 204 patients to receive placebo or 45 mg, 150 mg, or 300 mg of tralokinumab administered subcutaneously every second week for 12 weeks. The groups had similar demographics and disease characteristics. The patients were aged 15-75 years and had Eczema Area and Severity Index (EASI) scores of 12 or more and an Investigator Global Assessment (IGA) score of 3 or higher. The coprimary endpoints were change in EASI from baseline to week 12 and the percentage of patients with either 0 (clear) or 1 (almost clear) on the IGA scale.
The higher dosages of tralokinumab showed the greatest adjusted mean differences in EASI scores: reductions of 4.36 for the 150-mg group (P = .03) and 4.94 for the 300-mg group (P = .01), compared with placebo. The changes in the 300-mg group were apparent as early as 4 weeks into treatment and were maintained beyond the 12-week mark. The greatest differences, compared with placebo, in IGA were seen in the 300-mg group as well.
Furthermore, patients who had high levels of biomarkers associated with IL-13 showed greater improvements than those seen in the intention-to-treat population at large. By week 12, patient-reported pruritus was also improved, and there were improvements in Dermatology Quality of Life Index (which did not persist past 12 weeks).
Most treatment-emergent adverse events were considered only mild or moderate, and the few more serious events were deemed unrelated to the study drug. The most common adverse events were upper respiratory infections and headaches.
“Participants entering the study had not achieved an adequate response to stable topical glucocorticoids during the 2-week run-in period and, therefore, represent a population with moderate to severe AD and major unmet treatment needs,” the investigators wrote. “The clinically meaningful benefits observed by combining tralokinumab treatment with topical glucocorticoids suggests that tralokinumab could demonstrate improvements in participants whose symptoms cannot be effectively controlled by topical glucocorticoids alone.”
The study was funded by MedImmune, a member of the AstraZeneca Group. Five authors were or are employees of the company; the three remaining authors had disclosures related to numerous pharmaceutical companies, including two with disclosures that included MedImmune.
SOURCE: Wollenberg A et al. J Allergy Clin Immunol. 2018 Jun 12. doi: 10.1016/j.jaci.2018.05.029.
FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Administration eases way for small businesses to buy insurance in bulk
Small employers will more easily be able to band together to buy health insurance under rules issued June 19 by the Trump administration, but the change could raise premiums for plans sold through the Affordable Care Act’s (ACA’s) online marketplaces, analysts say.
The move loosens restrictions on so-called association health plans, allowing more businesses, including sole proprietors, to join forces to buy health coverage in bulk for their workers.
By effectively shifting small-business coverage into the large-group market, it exempts such plans from ACA requirements for 10 “essential” health benefits, such as mental health care and prescription drug coverage, prompting warnings of “junk insurance” from consumer advocates.
Supporters say the new Labor Department rules, which the government estimated could create health plans covering as many as 11 million people, will lead to more affordable choices for some employers.
When it comes to health insurance, “the regulatory burden on small businesses should certainly not be more than that on large companies,” Labor Secretary Alexander Acosta told reporters June 19.
Existing rules limit association plans to groups of employers in the same industry in the same region.
The new regulations eliminate the geographical restriction for similar employers, allowing, for example, family-owned auto-repair shops in multiple states to offer one big health plan, said Christopher Condeluci, a health benefits lawyer and former Senate Finance Committee aide.
The rules, to be implemented in stages into next year, also allow companies in different industries in the same region to form a group to offer coverage – even if the only reason is to provide health insurance.
Like other coverage under the ACA, association insurance plans will still be required to cover preexisting illnesses.
Analysts warn that, because these changes will likely siphon away employers with relatively healthy consumers from ACA coverage into less-expensive trade-association plans, the result could be higher costs in the online marketplaces.
“If you have a group that is healthier than average, you might get a better rate from one of these plans, and your broker is going to come and say, ‘Hey, I can get you a better deal,’ ” said Dan Mendelson, president of Avalere Health, a consulting firm.
That would mean that, on balance, consumers insured through ACA small-group and individual plans could be older, sicker, and more expensive, adding to years of erosion of the ACA marketplaces engineered by Republicans hostile to the law.
Loosening rules for association plans would lead to 3.2 million people leaving the ACA plans by 2022 and raising premiums for those remaining in individual markets by 3.5%, Avalere calculated this year.
America’s Health Insurance Plans, the largest medical insurance trade group, issued a statement saying the regulation “may lead to higher premiums” in ACA insurance and “could result in fewer insured Americans.”
Unlike ACA plans, association coverage does not have to include benefits across the broad “essential” categories, including hospitalization and emergency care.
The National Association of Insurance Commissioners previously warned that such plans “threaten the stability of the small group market” and “provide inadequate benefits and insufficient protection to consumers.”
The American Academy of Actuaries has expressed similar concerns.
Business groups praised the change, proposed in draft form earlier this year.
“We’ve been advocating for association health plans for almost 20 years, and we’re pleased to see the department moving aggressively forward,” said David French, senior vice president of government relations for the National Retail Federation.
Association plans have been around for decades, although enrollment has been more limited since the ACA’s passage. While some of the plans have worked well for their members, others have a checkered history.
In April, for example, Massachusetts regulators settled with Kansas-based Unified Life Insurance Company, which agreed to pay $2.8 million to resolve allegations that it engaged in deceptive practices, such as claiming it covered services that it did not.
The coverage “was sold across state lines and was issued through a third-party association,” according to a release from the Massachusetts attorney general’s office.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Small employers will more easily be able to band together to buy health insurance under rules issued June 19 by the Trump administration, but the change could raise premiums for plans sold through the Affordable Care Act’s (ACA’s) online marketplaces, analysts say.
The move loosens restrictions on so-called association health plans, allowing more businesses, including sole proprietors, to join forces to buy health coverage in bulk for their workers.
By effectively shifting small-business coverage into the large-group market, it exempts such plans from ACA requirements for 10 “essential” health benefits, such as mental health care and prescription drug coverage, prompting warnings of “junk insurance” from consumer advocates.
Supporters say the new Labor Department rules, which the government estimated could create health plans covering as many as 11 million people, will lead to more affordable choices for some employers.
When it comes to health insurance, “the regulatory burden on small businesses should certainly not be more than that on large companies,” Labor Secretary Alexander Acosta told reporters June 19.
Existing rules limit association plans to groups of employers in the same industry in the same region.
The new regulations eliminate the geographical restriction for similar employers, allowing, for example, family-owned auto-repair shops in multiple states to offer one big health plan, said Christopher Condeluci, a health benefits lawyer and former Senate Finance Committee aide.
The rules, to be implemented in stages into next year, also allow companies in different industries in the same region to form a group to offer coverage – even if the only reason is to provide health insurance.
Like other coverage under the ACA, association insurance plans will still be required to cover preexisting illnesses.
Analysts warn that, because these changes will likely siphon away employers with relatively healthy consumers from ACA coverage into less-expensive trade-association plans, the result could be higher costs in the online marketplaces.
“If you have a group that is healthier than average, you might get a better rate from one of these plans, and your broker is going to come and say, ‘Hey, I can get you a better deal,’ ” said Dan Mendelson, president of Avalere Health, a consulting firm.
That would mean that, on balance, consumers insured through ACA small-group and individual plans could be older, sicker, and more expensive, adding to years of erosion of the ACA marketplaces engineered by Republicans hostile to the law.
Loosening rules for association plans would lead to 3.2 million people leaving the ACA plans by 2022 and raising premiums for those remaining in individual markets by 3.5%, Avalere calculated this year.
America’s Health Insurance Plans, the largest medical insurance trade group, issued a statement saying the regulation “may lead to higher premiums” in ACA insurance and “could result in fewer insured Americans.”
Unlike ACA plans, association coverage does not have to include benefits across the broad “essential” categories, including hospitalization and emergency care.
The National Association of Insurance Commissioners previously warned that such plans “threaten the stability of the small group market” and “provide inadequate benefits and insufficient protection to consumers.”
The American Academy of Actuaries has expressed similar concerns.
Business groups praised the change, proposed in draft form earlier this year.
“We’ve been advocating for association health plans for almost 20 years, and we’re pleased to see the department moving aggressively forward,” said David French, senior vice president of government relations for the National Retail Federation.
Association plans have been around for decades, although enrollment has been more limited since the ACA’s passage. While some of the plans have worked well for their members, others have a checkered history.
In April, for example, Massachusetts regulators settled with Kansas-based Unified Life Insurance Company, which agreed to pay $2.8 million to resolve allegations that it engaged in deceptive practices, such as claiming it covered services that it did not.
The coverage “was sold across state lines and was issued through a third-party association,” according to a release from the Massachusetts attorney general’s office.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Small employers will more easily be able to band together to buy health insurance under rules issued June 19 by the Trump administration, but the change could raise premiums for plans sold through the Affordable Care Act’s (ACA’s) online marketplaces, analysts say.
The move loosens restrictions on so-called association health plans, allowing more businesses, including sole proprietors, to join forces to buy health coverage in bulk for their workers.
By effectively shifting small-business coverage into the large-group market, it exempts such plans from ACA requirements for 10 “essential” health benefits, such as mental health care and prescription drug coverage, prompting warnings of “junk insurance” from consumer advocates.
Supporters say the new Labor Department rules, which the government estimated could create health plans covering as many as 11 million people, will lead to more affordable choices for some employers.
When it comes to health insurance, “the regulatory burden on small businesses should certainly not be more than that on large companies,” Labor Secretary Alexander Acosta told reporters June 19.
Existing rules limit association plans to groups of employers in the same industry in the same region.
The new regulations eliminate the geographical restriction for similar employers, allowing, for example, family-owned auto-repair shops in multiple states to offer one big health plan, said Christopher Condeluci, a health benefits lawyer and former Senate Finance Committee aide.
The rules, to be implemented in stages into next year, also allow companies in different industries in the same region to form a group to offer coverage – even if the only reason is to provide health insurance.
Like other coverage under the ACA, association insurance plans will still be required to cover preexisting illnesses.
Analysts warn that, because these changes will likely siphon away employers with relatively healthy consumers from ACA coverage into less-expensive trade-association plans, the result could be higher costs in the online marketplaces.
“If you have a group that is healthier than average, you might get a better rate from one of these plans, and your broker is going to come and say, ‘Hey, I can get you a better deal,’ ” said Dan Mendelson, president of Avalere Health, a consulting firm.
That would mean that, on balance, consumers insured through ACA small-group and individual plans could be older, sicker, and more expensive, adding to years of erosion of the ACA marketplaces engineered by Republicans hostile to the law.
Loosening rules for association plans would lead to 3.2 million people leaving the ACA plans by 2022 and raising premiums for those remaining in individual markets by 3.5%, Avalere calculated this year.
America’s Health Insurance Plans, the largest medical insurance trade group, issued a statement saying the regulation “may lead to higher premiums” in ACA insurance and “could result in fewer insured Americans.”
Unlike ACA plans, association coverage does not have to include benefits across the broad “essential” categories, including hospitalization and emergency care.
The National Association of Insurance Commissioners previously warned that such plans “threaten the stability of the small group market” and “provide inadequate benefits and insufficient protection to consumers.”
The American Academy of Actuaries has expressed similar concerns.
Business groups praised the change, proposed in draft form earlier this year.
“We’ve been advocating for association health plans for almost 20 years, and we’re pleased to see the department moving aggressively forward,” said David French, senior vice president of government relations for the National Retail Federation.
Association plans have been around for decades, although enrollment has been more limited since the ACA’s passage. While some of the plans have worked well for their members, others have a checkered history.
In April, for example, Massachusetts regulators settled with Kansas-based Unified Life Insurance Company, which agreed to pay $2.8 million to resolve allegations that it engaged in deceptive practices, such as claiming it covered services that it did not.
The coverage “was sold across state lines and was issued through a third-party association,” according to a release from the Massachusetts attorney general’s office.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Parents say cancer prevention is the best reason to give HPV vaccine
according to an analysis of a national survey.
Preventing a common infection also ranked highly as a reason for giving the vaccine, as did appeals to the vaccine’s lasting benefits and safety, the analysis showed.
The findings strongly support prioritizing cancer prevention as a reason for HPV vaccination, reported Melissa B. Gilkey, PhD, of the University of North Carolina Gillings School of Global Public Health, Chapel Hill, and her associates.
“To achieve widespread coverage, healthcare providers need strategies for more effectively and efficiently communicating its value,” Dr. Gilkey and her colleagues reported in Cancer Epidemiology, Biomarkers & Prevention.
The findings were based on responses obtained in the Adolescent Cancer Prevention Communication Study, a 2016 online survey completed by 1,259 parents of adolescents.
A total of 1,177 parent were included in this analysis after excluding surveys that were incomplete with regard to questions on provider communication about HPV vaccination.
In the online survey, parents were asked to rank, from best to worst, a list of 11 reasons providers commonly give to encourage parents to consider HPV vaccination for their child.
Overall, parents ranked cancer prevention as the best reason for guideline-consistent HPV vaccination (beta = 2.07), followed by preventing a common infection (beta = 0.68), having lasting benefits (beta = 0.67), and being a safe vaccine (beta = 0.41).
The worst reasons, as ranked by these parents, were “your child is due for it” (beta = –1.08), “I got it for my own child” (beta = –0.98), and “it is a scientific breakthrough” (beta = –0.67).
Researchers hypothesized that parents with low vaccination confidence would have different preferences. While those parents did less often endorse cancer prevention and a few other questions, the variation was minor and resulted in few differences versus the overall parent rankings, according to Dr. Gilkey and her colleagues.
“Although parents with low confidence may find top reasons for HPV vaccination less compelling, they would not necessarily benefit from targeted messaging,” they wrote.
The study was funded by the National Cancer Institute. Dr. Gilkey and coauthors had no potential conflicts of interest to disclose.
SOURCE: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.
according to an analysis of a national survey.
Preventing a common infection also ranked highly as a reason for giving the vaccine, as did appeals to the vaccine’s lasting benefits and safety, the analysis showed.
The findings strongly support prioritizing cancer prevention as a reason for HPV vaccination, reported Melissa B. Gilkey, PhD, of the University of North Carolina Gillings School of Global Public Health, Chapel Hill, and her associates.
“To achieve widespread coverage, healthcare providers need strategies for more effectively and efficiently communicating its value,” Dr. Gilkey and her colleagues reported in Cancer Epidemiology, Biomarkers & Prevention.
The findings were based on responses obtained in the Adolescent Cancer Prevention Communication Study, a 2016 online survey completed by 1,259 parents of adolescents.
A total of 1,177 parent were included in this analysis after excluding surveys that were incomplete with regard to questions on provider communication about HPV vaccination.
In the online survey, parents were asked to rank, from best to worst, a list of 11 reasons providers commonly give to encourage parents to consider HPV vaccination for their child.
Overall, parents ranked cancer prevention as the best reason for guideline-consistent HPV vaccination (beta = 2.07), followed by preventing a common infection (beta = 0.68), having lasting benefits (beta = 0.67), and being a safe vaccine (beta = 0.41).
The worst reasons, as ranked by these parents, were “your child is due for it” (beta = –1.08), “I got it for my own child” (beta = –0.98), and “it is a scientific breakthrough” (beta = –0.67).
Researchers hypothesized that parents with low vaccination confidence would have different preferences. While those parents did less often endorse cancer prevention and a few other questions, the variation was minor and resulted in few differences versus the overall parent rankings, according to Dr. Gilkey and her colleagues.
“Although parents with low confidence may find top reasons for HPV vaccination less compelling, they would not necessarily benefit from targeted messaging,” they wrote.
The study was funded by the National Cancer Institute. Dr. Gilkey and coauthors had no potential conflicts of interest to disclose.
SOURCE: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.
according to an analysis of a national survey.
Preventing a common infection also ranked highly as a reason for giving the vaccine, as did appeals to the vaccine’s lasting benefits and safety, the analysis showed.
The findings strongly support prioritizing cancer prevention as a reason for HPV vaccination, reported Melissa B. Gilkey, PhD, of the University of North Carolina Gillings School of Global Public Health, Chapel Hill, and her associates.
“To achieve widespread coverage, healthcare providers need strategies for more effectively and efficiently communicating its value,” Dr. Gilkey and her colleagues reported in Cancer Epidemiology, Biomarkers & Prevention.
The findings were based on responses obtained in the Adolescent Cancer Prevention Communication Study, a 2016 online survey completed by 1,259 parents of adolescents.
A total of 1,177 parent were included in this analysis after excluding surveys that were incomplete with regard to questions on provider communication about HPV vaccination.
In the online survey, parents were asked to rank, from best to worst, a list of 11 reasons providers commonly give to encourage parents to consider HPV vaccination for their child.
Overall, parents ranked cancer prevention as the best reason for guideline-consistent HPV vaccination (beta = 2.07), followed by preventing a common infection (beta = 0.68), having lasting benefits (beta = 0.67), and being a safe vaccine (beta = 0.41).
The worst reasons, as ranked by these parents, were “your child is due for it” (beta = –1.08), “I got it for my own child” (beta = –0.98), and “it is a scientific breakthrough” (beta = –0.67).
Researchers hypothesized that parents with low vaccination confidence would have different preferences. While those parents did less often endorse cancer prevention and a few other questions, the variation was minor and resulted in few differences versus the overall parent rankings, according to Dr. Gilkey and her colleagues.
“Although parents with low confidence may find top reasons for HPV vaccination less compelling, they would not necessarily benefit from targeted messaging,” they wrote.
The study was funded by the National Cancer Institute. Dr. Gilkey and coauthors had no potential conflicts of interest to disclose.
SOURCE: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.
FROM CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION
Key clinical point: Among the reasons health care providers give parents for adolescent HPV vaccination, cancer prevention may be the best.
Major finding: Cancer prevention ranked highest (beta = 2.07), followed by preventing a common infection (beta = 0.68), having lasting benefits (beta = 0.67), and being a safe vaccine (beta = 0.41).
Study details: An analysis of 1,177 responses from parents of adolescents obtained in the Adolescent Cancer Prevention Communication Study, a 2016 online survey.
Disclosures: The study was funded by the National Cancer Institute. Study authors had no potential conflicts of interest to disclose.
Source: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.
Blood and tissue TMB help predict checkpoint inhibition response in NSCLC
CHICAGO – according to interim findings from the ongoing B-F1RST study and a retrospective analysis of data from several prior studies.
The retrospective analysis also demonstrated the value of tissue tumor mutational burden (tTMB) as a biomarker for checkpoint inhibition benefit in patients with metastatic urothelial carcinoma and melanoma.
Progression-free survival (PFS) at a minimum of 6 months in 58 evaluable NSCLC patients from the single-arm phase 2b B-F1RST study of first-line atezolizumab monotherapy was 9.5 vs. 2.8 months in those with a high (16 or greater mutations/coding sequence) vs. low (less than 16 mutations/coding sequence) blood tumor mutational burden (bTMB) score (hazard ratio, 0.49), Vamsidhar Velcheti, MD, reported during an oral abstract session at the annual meeting of the American Society of Clinical Oncology.
Progression-free survival hazard ratios improved as bTMB scores increased, explained Dr. Velcheti, associate director of the Center for Immuno-Oncology Research at Taussig Cancer Institute, Cleveland Clinic.
“At the prespecified cutoff of 16, the hazard ratio is 0.51 and this suggests strong correlation of bTMB with clinical benefit,” he said.
The objective response rate in these biomarker evaluable patients was 12.1% and the disease control rate was 25.9%; in the high vs. low bTMB patients the overall response rate was 36.4% vs. 6.4%, he noted, adding that the responses in the high bTMB patients were deeper and more durable, and the safety profile of atezolizumab (Tecentriq) in the trial thus far is consistent with the known adverse event profile for the agent.
Further, prior studies, including the randomized phase 3 OAK and phase 2 POPLAR studies of second-line atezolizumab monotherapy, showed that high bTMB was associated with a PFS benefit.
In the current study, bTMB was evaluated prospectively for the first time as a predictive marker for first-line atezolizumab in stage IIIb-IVb locally advanced or metastatic NSCLC using a next-generation sequencing-based panel. Patients were treated with atezolizumab at a dose of 1,200 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or loss of clinical benefit.
The findings show preliminary utility of bTMB as a predictive biomarker for PFS and ORR, and further support bTMB selection of patients in the ongoing phase 3 B-FAST study, which is currently enrolling, Dr. Velcheti said, noting that the findings are encouraging, as 30% of patients with NSCLC have inadequate tumor tissue for molecular testing at diagnosis.
B-F1RST is also ongoing, but has completed enrollment at 153 patients. Primary analysis results will be presented later this year, he said.
Similarly, tTMB was associated with checkpoint inhibitor efficacy across tumor types and lines of therapy in the retrospective analysis of data from seven atezolizumab monotherapy trials.
The overall response rate (ORR) in 987 patients from those studies was 16%, but the response rates were 30% vs. 14% in 125 patients with high tTMB scores vs. 812 patients with low tTMB scores, David R. Gandara, MD, reported during the oral abstract session.
Median duration of response (DOR) was 16.6 months overall but was 29 vs. 14 months in those with high vs. low tTMB scores, respectively, added Dr. Gandara, a professor and director of the thoracic oncology program at the University of California, Davis.
This association was not seen in control cohorts of the three randomized studies included in the analysis (OAK, POPLAR, and IMvigor211), he noted, explaining that the pooled overall response rate in controls was 14.9%, and the response rate in those with high vs. low tTMB scores was 14.4% and 15.1%, respectively.
Further, an exploratory analysis of the three randomized studies showed that PFS increased with increasing levels of tumor mutational burden (TMB). The hazard ratio for PFS at TMB greater than or equal to 16 was 0.71, and the association occurred only in patients receiving atezolizumab.
“As has been previously reported from other studies, [high TMB] identifies a patient population which is distinct from [programmed death-ligand 1] immunohistochemistry and yet complementary,” he said, noting that both high tTMB and high PD-L1 have been shown to predict response independently, and in the current study it is the “small proportion of patients with both [high] TMB and PD-L1 ... that have the best response rate.”
The findings, which highlight “the association of high TMB and enrichment of ORR, DOR, and PFS benefit with atezolizumab monotherapy across indications and lines of therapy,” and demonstrate that high TMB may serve as a surrogate for neoantigen load (NAL – a component of TMB that has been linked with immune response) and complement PD-L1 expression in enriching for clinical benefit from immunotherapy, he concluded, noting that harmonization efforts are underway to standardize TMB platforms and computational algorithms.
Dr. Velcheti has reported financial relationships with Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, and many others. He has received research funding to his institution from Alkermes, Altor BioScience, Atreca, Bristol-Myers Squibb, and others. Dr. Gandara reported financial relationships with ARIAD, AstraZeneca, Boehringer Ingelheim, Celgene, and many others. He has received research funding to his institution from AstraZeneca/MedImmune, Bristol-Myers Squibb, Clovis Oncology, Genentech, and others.
SOURCES: Velcheti V et al. ASCO 2018 Abstract 12001; Legrand FA et al. ASCO 2018 Abstract 12000.
CHICAGO – according to interim findings from the ongoing B-F1RST study and a retrospective analysis of data from several prior studies.
The retrospective analysis also demonstrated the value of tissue tumor mutational burden (tTMB) as a biomarker for checkpoint inhibition benefit in patients with metastatic urothelial carcinoma and melanoma.
Progression-free survival (PFS) at a minimum of 6 months in 58 evaluable NSCLC patients from the single-arm phase 2b B-F1RST study of first-line atezolizumab monotherapy was 9.5 vs. 2.8 months in those with a high (16 or greater mutations/coding sequence) vs. low (less than 16 mutations/coding sequence) blood tumor mutational burden (bTMB) score (hazard ratio, 0.49), Vamsidhar Velcheti, MD, reported during an oral abstract session at the annual meeting of the American Society of Clinical Oncology.
Progression-free survival hazard ratios improved as bTMB scores increased, explained Dr. Velcheti, associate director of the Center for Immuno-Oncology Research at Taussig Cancer Institute, Cleveland Clinic.
“At the prespecified cutoff of 16, the hazard ratio is 0.51 and this suggests strong correlation of bTMB with clinical benefit,” he said.
The objective response rate in these biomarker evaluable patients was 12.1% and the disease control rate was 25.9%; in the high vs. low bTMB patients the overall response rate was 36.4% vs. 6.4%, he noted, adding that the responses in the high bTMB patients were deeper and more durable, and the safety profile of atezolizumab (Tecentriq) in the trial thus far is consistent with the known adverse event profile for the agent.
Further, prior studies, including the randomized phase 3 OAK and phase 2 POPLAR studies of second-line atezolizumab monotherapy, showed that high bTMB was associated with a PFS benefit.
In the current study, bTMB was evaluated prospectively for the first time as a predictive marker for first-line atezolizumab in stage IIIb-IVb locally advanced or metastatic NSCLC using a next-generation sequencing-based panel. Patients were treated with atezolizumab at a dose of 1,200 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or loss of clinical benefit.
The findings show preliminary utility of bTMB as a predictive biomarker for PFS and ORR, and further support bTMB selection of patients in the ongoing phase 3 B-FAST study, which is currently enrolling, Dr. Velcheti said, noting that the findings are encouraging, as 30% of patients with NSCLC have inadequate tumor tissue for molecular testing at diagnosis.
B-F1RST is also ongoing, but has completed enrollment at 153 patients. Primary analysis results will be presented later this year, he said.
Similarly, tTMB was associated with checkpoint inhibitor efficacy across tumor types and lines of therapy in the retrospective analysis of data from seven atezolizumab monotherapy trials.
The overall response rate (ORR) in 987 patients from those studies was 16%, but the response rates were 30% vs. 14% in 125 patients with high tTMB scores vs. 812 patients with low tTMB scores, David R. Gandara, MD, reported during the oral abstract session.
Median duration of response (DOR) was 16.6 months overall but was 29 vs. 14 months in those with high vs. low tTMB scores, respectively, added Dr. Gandara, a professor and director of the thoracic oncology program at the University of California, Davis.
This association was not seen in control cohorts of the three randomized studies included in the analysis (OAK, POPLAR, and IMvigor211), he noted, explaining that the pooled overall response rate in controls was 14.9%, and the response rate in those with high vs. low tTMB scores was 14.4% and 15.1%, respectively.
Further, an exploratory analysis of the three randomized studies showed that PFS increased with increasing levels of tumor mutational burden (TMB). The hazard ratio for PFS at TMB greater than or equal to 16 was 0.71, and the association occurred only in patients receiving atezolizumab.
“As has been previously reported from other studies, [high TMB] identifies a patient population which is distinct from [programmed death-ligand 1] immunohistochemistry and yet complementary,” he said, noting that both high tTMB and high PD-L1 have been shown to predict response independently, and in the current study it is the “small proportion of patients with both [high] TMB and PD-L1 ... that have the best response rate.”
The findings, which highlight “the association of high TMB and enrichment of ORR, DOR, and PFS benefit with atezolizumab monotherapy across indications and lines of therapy,” and demonstrate that high TMB may serve as a surrogate for neoantigen load (NAL – a component of TMB that has been linked with immune response) and complement PD-L1 expression in enriching for clinical benefit from immunotherapy, he concluded, noting that harmonization efforts are underway to standardize TMB platforms and computational algorithms.
Dr. Velcheti has reported financial relationships with Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, and many others. He has received research funding to his institution from Alkermes, Altor BioScience, Atreca, Bristol-Myers Squibb, and others. Dr. Gandara reported financial relationships with ARIAD, AstraZeneca, Boehringer Ingelheim, Celgene, and many others. He has received research funding to his institution from AstraZeneca/MedImmune, Bristol-Myers Squibb, Clovis Oncology, Genentech, and others.
SOURCES: Velcheti V et al. ASCO 2018 Abstract 12001; Legrand FA et al. ASCO 2018 Abstract 12000.
CHICAGO – according to interim findings from the ongoing B-F1RST study and a retrospective analysis of data from several prior studies.
The retrospective analysis also demonstrated the value of tissue tumor mutational burden (tTMB) as a biomarker for checkpoint inhibition benefit in patients with metastatic urothelial carcinoma and melanoma.
Progression-free survival (PFS) at a minimum of 6 months in 58 evaluable NSCLC patients from the single-arm phase 2b B-F1RST study of first-line atezolizumab monotherapy was 9.5 vs. 2.8 months in those with a high (16 or greater mutations/coding sequence) vs. low (less than 16 mutations/coding sequence) blood tumor mutational burden (bTMB) score (hazard ratio, 0.49), Vamsidhar Velcheti, MD, reported during an oral abstract session at the annual meeting of the American Society of Clinical Oncology.
Progression-free survival hazard ratios improved as bTMB scores increased, explained Dr. Velcheti, associate director of the Center for Immuno-Oncology Research at Taussig Cancer Institute, Cleveland Clinic.
“At the prespecified cutoff of 16, the hazard ratio is 0.51 and this suggests strong correlation of bTMB with clinical benefit,” he said.
The objective response rate in these biomarker evaluable patients was 12.1% and the disease control rate was 25.9%; in the high vs. low bTMB patients the overall response rate was 36.4% vs. 6.4%, he noted, adding that the responses in the high bTMB patients were deeper and more durable, and the safety profile of atezolizumab (Tecentriq) in the trial thus far is consistent with the known adverse event profile for the agent.
Further, prior studies, including the randomized phase 3 OAK and phase 2 POPLAR studies of second-line atezolizumab monotherapy, showed that high bTMB was associated with a PFS benefit.
In the current study, bTMB was evaluated prospectively for the first time as a predictive marker for first-line atezolizumab in stage IIIb-IVb locally advanced or metastatic NSCLC using a next-generation sequencing-based panel. Patients were treated with atezolizumab at a dose of 1,200 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or loss of clinical benefit.
The findings show preliminary utility of bTMB as a predictive biomarker for PFS and ORR, and further support bTMB selection of patients in the ongoing phase 3 B-FAST study, which is currently enrolling, Dr. Velcheti said, noting that the findings are encouraging, as 30% of patients with NSCLC have inadequate tumor tissue for molecular testing at diagnosis.
B-F1RST is also ongoing, but has completed enrollment at 153 patients. Primary analysis results will be presented later this year, he said.
Similarly, tTMB was associated with checkpoint inhibitor efficacy across tumor types and lines of therapy in the retrospective analysis of data from seven atezolizumab monotherapy trials.
The overall response rate (ORR) in 987 patients from those studies was 16%, but the response rates were 30% vs. 14% in 125 patients with high tTMB scores vs. 812 patients with low tTMB scores, David R. Gandara, MD, reported during the oral abstract session.
Median duration of response (DOR) was 16.6 months overall but was 29 vs. 14 months in those with high vs. low tTMB scores, respectively, added Dr. Gandara, a professor and director of the thoracic oncology program at the University of California, Davis.
This association was not seen in control cohorts of the three randomized studies included in the analysis (OAK, POPLAR, and IMvigor211), he noted, explaining that the pooled overall response rate in controls was 14.9%, and the response rate in those with high vs. low tTMB scores was 14.4% and 15.1%, respectively.
Further, an exploratory analysis of the three randomized studies showed that PFS increased with increasing levels of tumor mutational burden (TMB). The hazard ratio for PFS at TMB greater than or equal to 16 was 0.71, and the association occurred only in patients receiving atezolizumab.
“As has been previously reported from other studies, [high TMB] identifies a patient population which is distinct from [programmed death-ligand 1] immunohistochemistry and yet complementary,” he said, noting that both high tTMB and high PD-L1 have been shown to predict response independently, and in the current study it is the “small proportion of patients with both [high] TMB and PD-L1 ... that have the best response rate.”
The findings, which highlight “the association of high TMB and enrichment of ORR, DOR, and PFS benefit with atezolizumab monotherapy across indications and lines of therapy,” and demonstrate that high TMB may serve as a surrogate for neoantigen load (NAL – a component of TMB that has been linked with immune response) and complement PD-L1 expression in enriching for clinical benefit from immunotherapy, he concluded, noting that harmonization efforts are underway to standardize TMB platforms and computational algorithms.
Dr. Velcheti has reported financial relationships with Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, and many others. He has received research funding to his institution from Alkermes, Altor BioScience, Atreca, Bristol-Myers Squibb, and others. Dr. Gandara reported financial relationships with ARIAD, AstraZeneca, Boehringer Ingelheim, Celgene, and many others. He has received research funding to his institution from AstraZeneca/MedImmune, Bristol-Myers Squibb, Clovis Oncology, Genentech, and others.
SOURCES: Velcheti V et al. ASCO 2018 Abstract 12001; Legrand FA et al. ASCO 2018 Abstract 12000.
REPORTING FROM ASCO 2018
Key clinical point: High bTMB and tTMB may help predict checkpoint inhibition response in NSCLC patients.
Major finding: PFS in NSCLC patients in the B-F1RST study was 9.5 vs. 2.8 months in those with a high vs. low bTMB score (hazard ratio, 0.49).
Study details: The phase 2b B-F1RST study including 58 evaluable patients and a retrospective analysis of 7 studies including 987 evaluable patients.
Disclosures: Dr. Velcheti has reported financial relationships with Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, and many others. He has received research funding to his institution from Alkermes, Altor BioScience, Atreca, Bristol-Myers Squibb, and others. Dr. Gandara reported financial relationships with ARIAD, AstraZeneca, Boehringer Ingelheim, Celgene, and many others. He has received research funding to his institution from AstraZeneca/MedImmune, Bristol-Myers Squibb, Clovis Oncology, Genentech, and others.
Sources: Velcheti V et al. ASCO 2018 Abstract 12001; Legrand FA et al. ASCO 2018 Abstract 12000.
Hemophilia adherence tied to perception of disease
More than half (56%) of adult patients with hemophilia are adherent to a prescribed prophylaxis regimen, but compliance appears less likely among patients who are having difficulty coping with pain or have a high conviction of disease.
Ana Torres-Ortuño, PhD, of the University of Murcia (Spain) and her colleagues performed a multicenter, cross-sectional descriptive study of 23 adult patients with severe hemophilia A or hemophilia B using various validated questionnaires that measured quality of life, disease perception, coping strategies, and treatment adherence.
The researchers found that Patients who experienced haemarthrosis with greater frequency had significantly greater adherence in terms of dosing (P less than .05), planning (P less than .05), and skipping (P less than .01). Similarly, patients with HIV infection were more adherent in terms of frequency of infusion than patients without infection.
The researchers also found significant correlations among all the psychosocial variables measured and adherence to prophylaxis. For instance, patients who had poorer quality of life related to managing their physical health, pain, and emotions showed poorer planning of their treatment. Patients who had difficulty remembering treatment had poorer quality of life related to pain and vitality, but they also had greater conviction of disease and hypochondriasis.
“Intervention programmes should be aimed more at changing barriers that patients and caregivers encounter when accepting diagnosis and how they can adapt their resources and skills to better take advantage of the progress made in treatments,” the researchers wrote.
The study was supported by a grant from Pfizer. The researchers reported having no financial disclosures.
SOURCE: Torres-Ortuño A et al. Vox Sang. 2018 May 24. doi: 10.1111/vox.12669.
More than half (56%) of adult patients with hemophilia are adherent to a prescribed prophylaxis regimen, but compliance appears less likely among patients who are having difficulty coping with pain or have a high conviction of disease.
Ana Torres-Ortuño, PhD, of the University of Murcia (Spain) and her colleagues performed a multicenter, cross-sectional descriptive study of 23 adult patients with severe hemophilia A or hemophilia B using various validated questionnaires that measured quality of life, disease perception, coping strategies, and treatment adherence.
The researchers found that Patients who experienced haemarthrosis with greater frequency had significantly greater adherence in terms of dosing (P less than .05), planning (P less than .05), and skipping (P less than .01). Similarly, patients with HIV infection were more adherent in terms of frequency of infusion than patients without infection.
The researchers also found significant correlations among all the psychosocial variables measured and adherence to prophylaxis. For instance, patients who had poorer quality of life related to managing their physical health, pain, and emotions showed poorer planning of their treatment. Patients who had difficulty remembering treatment had poorer quality of life related to pain and vitality, but they also had greater conviction of disease and hypochondriasis.
“Intervention programmes should be aimed more at changing barriers that patients and caregivers encounter when accepting diagnosis and how they can adapt their resources and skills to better take advantage of the progress made in treatments,” the researchers wrote.
The study was supported by a grant from Pfizer. The researchers reported having no financial disclosures.
SOURCE: Torres-Ortuño A et al. Vox Sang. 2018 May 24. doi: 10.1111/vox.12669.
More than half (56%) of adult patients with hemophilia are adherent to a prescribed prophylaxis regimen, but compliance appears less likely among patients who are having difficulty coping with pain or have a high conviction of disease.
Ana Torres-Ortuño, PhD, of the University of Murcia (Spain) and her colleagues performed a multicenter, cross-sectional descriptive study of 23 adult patients with severe hemophilia A or hemophilia B using various validated questionnaires that measured quality of life, disease perception, coping strategies, and treatment adherence.
The researchers found that Patients who experienced haemarthrosis with greater frequency had significantly greater adherence in terms of dosing (P less than .05), planning (P less than .05), and skipping (P less than .01). Similarly, patients with HIV infection were more adherent in terms of frequency of infusion than patients without infection.
The researchers also found significant correlations among all the psychosocial variables measured and adherence to prophylaxis. For instance, patients who had poorer quality of life related to managing their physical health, pain, and emotions showed poorer planning of their treatment. Patients who had difficulty remembering treatment had poorer quality of life related to pain and vitality, but they also had greater conviction of disease and hypochondriasis.
“Intervention programmes should be aimed more at changing barriers that patients and caregivers encounter when accepting diagnosis and how they can adapt their resources and skills to better take advantage of the progress made in treatments,” the researchers wrote.
The study was supported by a grant from Pfizer. The researchers reported having no financial disclosures.
SOURCE: Torres-Ortuño A et al. Vox Sang. 2018 May 24. doi: 10.1111/vox.12669.
FROM VOX SANGUINIS
Preop Cognitive Issues and Surgery Type Affect Postop Delirium
Postoperative delirium has a high prevalence among vascular surgery patients, increasing morbidity, mortality and length of stay (LOS),according to Rima G. Styra, MD, and her colleagues at the University of Toronto (Canada).
In Friday’s Scientific Session 5, Dr. Styra will present their prospective study, which found that there were preop risk factors for delirium that can be determined by a surgical team in order to identify high risk patients; their study also looked at the impacts of delirium on hospital costs.
She and her colleagues preoperatively assessed 173 elective vascular surgery patients for cognitive function using the Montreal Cognitive Assessment Scale (MoCA) and the Confusion Assessment Method (CAM) for postoperative delirium, which was verified by chart and clinical review.
Demographic information, medications and a history of substance abuse, psychiatric disorders, previous delirium and the surgical procedure were prospectively recorded. An accompanying retrospective chart review of an additional 434 (elective and emergency) vascular surgery patients provided supplemental cost information related to sitter use and prolonged hospitalization secondary to three factors: delirium alone, dementia alone, and delirium and dementia.
Prospective screening of 173 patients (73.4% men, mean age 69.9 years), identified that 119 (68.8%) had MoCA scores indicating cognitive impairment, with 7.5% having severe impairment (dementia). Patients who underwent amputation had significantly lower MoCA scores (15.9 out of 30) compared to open and endovascular aortic surgery patients (23.6 out of 30). The normal range for MoCA is 25-30.
The incidence of delirium was 12% in the elective cohort. Regression analysis identified significant predictors of delirium including type of surgery: lower limb amputation (OR 16.7), open aortic repair (OR 5.3), and cognitive variables: dementia (OR 5.6), and MoCA scores indicating moderate to severe impairment (OR 5.6), and previous delirium (OR 3.0).
Retrospective review of 434 patients identified differences between sitter needs for patients with delirium and dementia (mean = 13.6 days), delirium alone (3.9 days) or dementia alone (less than 1day [17.7 hours]). A total of 15 patients required more than 200 hours (8.3 days), accounting for 69.7% of sitter costs for the surgical unit. Patients with underlying dementia who developed delirium accounted for 48% of the total surgical unit sitter days.
“Postoperative delirium is predicted by type of vascular surgery, impaired cognition (MoCA), and previous delirium. Costs and morbidity related to delirium are greatest for those with impaired cognitive burden. Preoperative MoCA screening can identify those at highest risk, allowing for patient and family education regarding post-operative delirium risk, procedure modification and informed care,” Dr. Styra and her colleagues concluded.
Friday, June 22
3:30–5 p.m.
HCC, Ballroom A/B
SS26: The Impact of Pre-Operative Cognitive Impairment and Type of Vascular Surgery on Postoperative Delirium and Cost Implications
Postoperative delirium has a high prevalence among vascular surgery patients, increasing morbidity, mortality and length of stay (LOS),according to Rima G. Styra, MD, and her colleagues at the University of Toronto (Canada).
In Friday’s Scientific Session 5, Dr. Styra will present their prospective study, which found that there were preop risk factors for delirium that can be determined by a surgical team in order to identify high risk patients; their study also looked at the impacts of delirium on hospital costs.
She and her colleagues preoperatively assessed 173 elective vascular surgery patients for cognitive function using the Montreal Cognitive Assessment Scale (MoCA) and the Confusion Assessment Method (CAM) for postoperative delirium, which was verified by chart and clinical review.
Demographic information, medications and a history of substance abuse, psychiatric disorders, previous delirium and the surgical procedure were prospectively recorded. An accompanying retrospective chart review of an additional 434 (elective and emergency) vascular surgery patients provided supplemental cost information related to sitter use and prolonged hospitalization secondary to three factors: delirium alone, dementia alone, and delirium and dementia.
Prospective screening of 173 patients (73.4% men, mean age 69.9 years), identified that 119 (68.8%) had MoCA scores indicating cognitive impairment, with 7.5% having severe impairment (dementia). Patients who underwent amputation had significantly lower MoCA scores (15.9 out of 30) compared to open and endovascular aortic surgery patients (23.6 out of 30). The normal range for MoCA is 25-30.
The incidence of delirium was 12% in the elective cohort. Regression analysis identified significant predictors of delirium including type of surgery: lower limb amputation (OR 16.7), open aortic repair (OR 5.3), and cognitive variables: dementia (OR 5.6), and MoCA scores indicating moderate to severe impairment (OR 5.6), and previous delirium (OR 3.0).
Retrospective review of 434 patients identified differences between sitter needs for patients with delirium and dementia (mean = 13.6 days), delirium alone (3.9 days) or dementia alone (less than 1day [17.7 hours]). A total of 15 patients required more than 200 hours (8.3 days), accounting for 69.7% of sitter costs for the surgical unit. Patients with underlying dementia who developed delirium accounted for 48% of the total surgical unit sitter days.
“Postoperative delirium is predicted by type of vascular surgery, impaired cognition (MoCA), and previous delirium. Costs and morbidity related to delirium are greatest for those with impaired cognitive burden. Preoperative MoCA screening can identify those at highest risk, allowing for patient and family education regarding post-operative delirium risk, procedure modification and informed care,” Dr. Styra and her colleagues concluded.
Friday, June 22
3:30–5 p.m.
HCC, Ballroom A/B
SS26: The Impact of Pre-Operative Cognitive Impairment and Type of Vascular Surgery on Postoperative Delirium and Cost Implications
Postoperative delirium has a high prevalence among vascular surgery patients, increasing morbidity, mortality and length of stay (LOS),according to Rima G. Styra, MD, and her colleagues at the University of Toronto (Canada).
In Friday’s Scientific Session 5, Dr. Styra will present their prospective study, which found that there were preop risk factors for delirium that can be determined by a surgical team in order to identify high risk patients; their study also looked at the impacts of delirium on hospital costs.
She and her colleagues preoperatively assessed 173 elective vascular surgery patients for cognitive function using the Montreal Cognitive Assessment Scale (MoCA) and the Confusion Assessment Method (CAM) for postoperative delirium, which was verified by chart and clinical review.
Demographic information, medications and a history of substance abuse, psychiatric disorders, previous delirium and the surgical procedure were prospectively recorded. An accompanying retrospective chart review of an additional 434 (elective and emergency) vascular surgery patients provided supplemental cost information related to sitter use and prolonged hospitalization secondary to three factors: delirium alone, dementia alone, and delirium and dementia.
Prospective screening of 173 patients (73.4% men, mean age 69.9 years), identified that 119 (68.8%) had MoCA scores indicating cognitive impairment, with 7.5% having severe impairment (dementia). Patients who underwent amputation had significantly lower MoCA scores (15.9 out of 30) compared to open and endovascular aortic surgery patients (23.6 out of 30). The normal range for MoCA is 25-30.
The incidence of delirium was 12% in the elective cohort. Regression analysis identified significant predictors of delirium including type of surgery: lower limb amputation (OR 16.7), open aortic repair (OR 5.3), and cognitive variables: dementia (OR 5.6), and MoCA scores indicating moderate to severe impairment (OR 5.6), and previous delirium (OR 3.0).
Retrospective review of 434 patients identified differences between sitter needs for patients with delirium and dementia (mean = 13.6 days), delirium alone (3.9 days) or dementia alone (less than 1day [17.7 hours]). A total of 15 patients required more than 200 hours (8.3 days), accounting for 69.7% of sitter costs for the surgical unit. Patients with underlying dementia who developed delirium accounted for 48% of the total surgical unit sitter days.
“Postoperative delirium is predicted by type of vascular surgery, impaired cognition (MoCA), and previous delirium. Costs and morbidity related to delirium are greatest for those with impaired cognitive burden. Preoperative MoCA screening can identify those at highest risk, allowing for patient and family education regarding post-operative delirium risk, procedure modification and informed care,” Dr. Styra and her colleagues concluded.
Friday, June 22
3:30–5 p.m.
HCC, Ballroom A/B
SS26: The Impact of Pre-Operative Cognitive Impairment and Type of Vascular Surgery on Postoperative Delirium and Cost Implications