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High-Quality Diet in Early Life May Ward Off Later IBD
, prospective pooled data from two Scandinavian birth cohorts suggested.
It appears important to feed children a quality diet at a very young age, in particular one rich in vegetables and fish, since by age three, only dietary fish intake had any impact on IBD risk.
Although high intakes of these two food categories in very early life correlated with lower IBD risk, exposure to sugar-sweetened beverages (SSBs) was associated with an increased risk. “While non-causal explanations for our results cannot be ruled out, these novel findings are consistent with the hypothesis that early-life diet, possibly mediated through changes in the gut microbiome, may affect the risk of developing IBD,” wrote lead author Annie Guo, a PhD candidate in the Department of Pediatrics, University of Gothenburg, Sweden, and colleagues. The report was published in Gut.
“This is a population-based study investigating the risk for IBD, rather than the specific effect of diet,” Ms. Guo said in an interview. “Therefore, the results are not enough on their own to be translated into individual advice that can be applicable in the clinic. However, the study supports current dietary guidelines for small children, that is, the intake of sugar should be limited and a higher intake of fish and vegetables is beneficial for overall health.”
Two-Cohort Study
The investigators prospectively recorded food-group information on children (just under half were female) from the All Babies in Southeast Sweden and The Norwegian Mother, Father and Child Cohort Study to assess the diet quality using a Healthy Eating Index and intake frequency. Parents answered questions about their offspring’s diet at ages 12-18 months and 30-36 months. Quality of diet was measured by intake of meat, fish, fruit, vegetables, dairy, sweets, snacks, and drinks.
The Swedish cohort included 21,700 children born between October 1997 and October 1999, while the Norwegian analysis included 114,500 children, 95,200 mothers, and 75,200 fathers recruited from across Norway from 1999 to 2008. In 1,304,433 person-years of follow-up, the researchers tracked 81,280 participants from birth to childhood and adolescence, with median follow-ups in the two cohorts ranging from 1 year of age to 21.3 years (Sweden) and to 15.2 years of age (Norway). Of these children, 307 were diagnosed with IBD: Crohn’s disease (CD; n = 131); ulcerative colitis (UC; n = 97); and IBD unclassified (n = 79).
Adjusting for parental IBD history, sex, origin, education, and maternal comorbidities, the study found:
- Compared with low-quality diet, both medium- and high-quality diets at 1 year were associated with a roughly 25% reduced risk for IBD (pooled adjusted hazard ratio [aHR], 0.75 [95% CI, 0.58-0.98] and 0.75 [0.56-1.0], respectively).
- The pooled aHR per increase of category was 0.86 (95% CI, 0.74-0.99). The pooled aHR for IBD in 1-year-olds with high vs low fish intake was 0.70 (95% CI, 0.49-1.0), and this diet showed an association with a reduced risk for UC (pooled aHR, 0.46; 95% CI, 0.21-0.99). Higher vegetable intake at 1 year was also associated with a risk reduction in IBD (HR, 0.72; 95% CI, 0.55-0.95). It has been hypothesized that intake of vegetables and vegetable fibers may have programming effects on the immune system.
- AutoWith 72% of children reportedly consuming SSBs at age 1, pooled aHRs showed that some vs no intake of SSBs was associated with an increased risk for later IBD (pooled aHR, 1.42; 95% CI, 1.05-1.90).
- There were no obvious associations between overall IBD or CD/UC risk and meat, dairy, fruit, grains, potatoes, and foods high in sugar and/or fat. Diet at age 3 years was not associated with incident IBD (pooled aHR, 1.02; 95% CI, 0.76-1.37), suggesting that the risk impact of diet is greatest on very young and vulnerable microbiomes.
Ms. Guo noted that a Swedish national survey among 4-year-olds found a mean SSB consumption of 187 g/d with a mean frequency of once daily. The most desired changes in food habits are a lower intake of soft drinks, sweets, crisps, cakes, and biscuits and an increase in the intake of fruits and vegetables. A similar Norwegian survey among 2-year-olds showed that SSBs were consumed by 36% of all children with a mean intake of 40 g/d.
The exact mechanism by which sugar affects the intestinal microbiota is not established. “However, what we do know is that an excessive intake of sugar can disrupt the balance of the gut microbiome,” Ms. Guo said. “And if the child has a high intake of foods with high in sugar, that also increases the chances that the child’s overall diet has a lower intake of other foods that contribute to a diverse microbiome such as fruits and vegetables.”
An ‘Elegant’ Study
In an accompanying editorial, gastroenterologist Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, of Mass General Brigham and the Mass General Research Institute, Boston, cautioned that accurately measuring food intake in very young children is difficult, and dietary questionnaires in this study did not address food additives and emulsifiers common in commercial baby food, which may play a role in the pathogenesis of IBD.
Another study limitation is that the dietary questionnaire used has not been qualitatively or quantitatively validated against other more conventional methods, said Dr. Ananthakrishnan, who was not involved in the research.
Nevertheless, he called the study “elegant” and expanding of the data on the importance of this period in IBD development. “Although in the present study there was no association between diet at 3 years and development of IBD (in contrast to the association observed for dietary intake at 1 year), other prospective cohorts of adult-onset IBD have demonstrated an inverse association between vegetable or fish intake and reduced risk for CD while sugar-sweetened beverages have been linked to a higher risk for IBD.”
As to the question of recommending early preventive diet for IBD, “thus far, data on the impact of diet very early in childhood, outside of breastfeeding, on the risk for IBD has been lacking,” Dr. Ananthakrishnan said in an interview. “This important study highlights that diet as early as 1 year can modify subsequent risk for IBD. This raises the intriguing possibility of whether early changes in diet could be used, particularly in those at higher risk, to reduce or even prevent future development of IBD. Of course, more works needs to be done to define modifiability of diet as a risk factor, but this is an important supportive data.”
In his editorial, Dr. Ananthakrishnan stated that despite the absence of gold-standard interventional data demonstrating a benefit of dietary interventions, “in my opinion, it may still be reasonable to suggest such interventions to motivate individuals who incorporate several of the dietary patterns associated with lower risk for IBD from this and other studies. This includes ensuring adequate dietary fiber, particularly from fruits and vegetables, intake of fish, minimizing sugar-sweetened beverages and preferring fresh over processed and ultra-processed foods and snacks.” According to the study authors, their novel findings support further research on the role of childhood diet in the prevention of IBD.
The All Babies in Southeast Sweden Study is supported by Barndiabetesfonden (Swedish Child Diabetes Foundation), the Swedish Council for Working Life and Social Research, the Swedish Research Council, the Medical Research Council of Southeast Sweden, the JDRF Wallenberg Foundation, ALF and LFoU grants from Region Östergötland and Linköping University, and the Joanna Cocozza Foundation.
The Norwegian Mother, Father and Child Cohort Study is supported by the Norwegian Ministry of Health and Care Services and the Ministry of Education and Research.
Ms. Guo received grants from the Swedish Society for Medical Research and the Henning and Johan Throne-Holst Foundation to conduct this study. Co-author Karl Mårild has received funding from the Swedish Society for Medical Research, the Swedish Research Council, and ALF, Sweden’s medical research and education co-ordinating body. The authors declared no competing interests. Dr. Ananthakrishnan is supported by the National Institutes of Health, the Leona M. and Harry B. Helmsley Charitable Trust, and the Chleck Family Foundation. He has served on the scientific advisory board for Geneoscopy.
, prospective pooled data from two Scandinavian birth cohorts suggested.
It appears important to feed children a quality diet at a very young age, in particular one rich in vegetables and fish, since by age three, only dietary fish intake had any impact on IBD risk.
Although high intakes of these two food categories in very early life correlated with lower IBD risk, exposure to sugar-sweetened beverages (SSBs) was associated with an increased risk. “While non-causal explanations for our results cannot be ruled out, these novel findings are consistent with the hypothesis that early-life diet, possibly mediated through changes in the gut microbiome, may affect the risk of developing IBD,” wrote lead author Annie Guo, a PhD candidate in the Department of Pediatrics, University of Gothenburg, Sweden, and colleagues. The report was published in Gut.
“This is a population-based study investigating the risk for IBD, rather than the specific effect of diet,” Ms. Guo said in an interview. “Therefore, the results are not enough on their own to be translated into individual advice that can be applicable in the clinic. However, the study supports current dietary guidelines for small children, that is, the intake of sugar should be limited and a higher intake of fish and vegetables is beneficial for overall health.”
Two-Cohort Study
The investigators prospectively recorded food-group information on children (just under half were female) from the All Babies in Southeast Sweden and The Norwegian Mother, Father and Child Cohort Study to assess the diet quality using a Healthy Eating Index and intake frequency. Parents answered questions about their offspring’s diet at ages 12-18 months and 30-36 months. Quality of diet was measured by intake of meat, fish, fruit, vegetables, dairy, sweets, snacks, and drinks.
The Swedish cohort included 21,700 children born between October 1997 and October 1999, while the Norwegian analysis included 114,500 children, 95,200 mothers, and 75,200 fathers recruited from across Norway from 1999 to 2008. In 1,304,433 person-years of follow-up, the researchers tracked 81,280 participants from birth to childhood and adolescence, with median follow-ups in the two cohorts ranging from 1 year of age to 21.3 years (Sweden) and to 15.2 years of age (Norway). Of these children, 307 were diagnosed with IBD: Crohn’s disease (CD; n = 131); ulcerative colitis (UC; n = 97); and IBD unclassified (n = 79).
Adjusting for parental IBD history, sex, origin, education, and maternal comorbidities, the study found:
- Compared with low-quality diet, both medium- and high-quality diets at 1 year were associated with a roughly 25% reduced risk for IBD (pooled adjusted hazard ratio [aHR], 0.75 [95% CI, 0.58-0.98] and 0.75 [0.56-1.0], respectively).
- The pooled aHR per increase of category was 0.86 (95% CI, 0.74-0.99). The pooled aHR for IBD in 1-year-olds with high vs low fish intake was 0.70 (95% CI, 0.49-1.0), and this diet showed an association with a reduced risk for UC (pooled aHR, 0.46; 95% CI, 0.21-0.99). Higher vegetable intake at 1 year was also associated with a risk reduction in IBD (HR, 0.72; 95% CI, 0.55-0.95). It has been hypothesized that intake of vegetables and vegetable fibers may have programming effects on the immune system.
- AutoWith 72% of children reportedly consuming SSBs at age 1, pooled aHRs showed that some vs no intake of SSBs was associated with an increased risk for later IBD (pooled aHR, 1.42; 95% CI, 1.05-1.90).
- There were no obvious associations between overall IBD or CD/UC risk and meat, dairy, fruit, grains, potatoes, and foods high in sugar and/or fat. Diet at age 3 years was not associated with incident IBD (pooled aHR, 1.02; 95% CI, 0.76-1.37), suggesting that the risk impact of diet is greatest on very young and vulnerable microbiomes.
Ms. Guo noted that a Swedish national survey among 4-year-olds found a mean SSB consumption of 187 g/d with a mean frequency of once daily. The most desired changes in food habits are a lower intake of soft drinks, sweets, crisps, cakes, and biscuits and an increase in the intake of fruits and vegetables. A similar Norwegian survey among 2-year-olds showed that SSBs were consumed by 36% of all children with a mean intake of 40 g/d.
The exact mechanism by which sugar affects the intestinal microbiota is not established. “However, what we do know is that an excessive intake of sugar can disrupt the balance of the gut microbiome,” Ms. Guo said. “And if the child has a high intake of foods with high in sugar, that also increases the chances that the child’s overall diet has a lower intake of other foods that contribute to a diverse microbiome such as fruits and vegetables.”
An ‘Elegant’ Study
In an accompanying editorial, gastroenterologist Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, of Mass General Brigham and the Mass General Research Institute, Boston, cautioned that accurately measuring food intake in very young children is difficult, and dietary questionnaires in this study did not address food additives and emulsifiers common in commercial baby food, which may play a role in the pathogenesis of IBD.
Another study limitation is that the dietary questionnaire used has not been qualitatively or quantitatively validated against other more conventional methods, said Dr. Ananthakrishnan, who was not involved in the research.
Nevertheless, he called the study “elegant” and expanding of the data on the importance of this period in IBD development. “Although in the present study there was no association between diet at 3 years and development of IBD (in contrast to the association observed for dietary intake at 1 year), other prospective cohorts of adult-onset IBD have demonstrated an inverse association between vegetable or fish intake and reduced risk for CD while sugar-sweetened beverages have been linked to a higher risk for IBD.”
As to the question of recommending early preventive diet for IBD, “thus far, data on the impact of diet very early in childhood, outside of breastfeeding, on the risk for IBD has been lacking,” Dr. Ananthakrishnan said in an interview. “This important study highlights that diet as early as 1 year can modify subsequent risk for IBD. This raises the intriguing possibility of whether early changes in diet could be used, particularly in those at higher risk, to reduce or even prevent future development of IBD. Of course, more works needs to be done to define modifiability of diet as a risk factor, but this is an important supportive data.”
In his editorial, Dr. Ananthakrishnan stated that despite the absence of gold-standard interventional data demonstrating a benefit of dietary interventions, “in my opinion, it may still be reasonable to suggest such interventions to motivate individuals who incorporate several of the dietary patterns associated with lower risk for IBD from this and other studies. This includes ensuring adequate dietary fiber, particularly from fruits and vegetables, intake of fish, minimizing sugar-sweetened beverages and preferring fresh over processed and ultra-processed foods and snacks.” According to the study authors, their novel findings support further research on the role of childhood diet in the prevention of IBD.
The All Babies in Southeast Sweden Study is supported by Barndiabetesfonden (Swedish Child Diabetes Foundation), the Swedish Council for Working Life and Social Research, the Swedish Research Council, the Medical Research Council of Southeast Sweden, the JDRF Wallenberg Foundation, ALF and LFoU grants from Region Östergötland and Linköping University, and the Joanna Cocozza Foundation.
The Norwegian Mother, Father and Child Cohort Study is supported by the Norwegian Ministry of Health and Care Services and the Ministry of Education and Research.
Ms. Guo received grants from the Swedish Society for Medical Research and the Henning and Johan Throne-Holst Foundation to conduct this study. Co-author Karl Mårild has received funding from the Swedish Society for Medical Research, the Swedish Research Council, and ALF, Sweden’s medical research and education co-ordinating body. The authors declared no competing interests. Dr. Ananthakrishnan is supported by the National Institutes of Health, the Leona M. and Harry B. Helmsley Charitable Trust, and the Chleck Family Foundation. He has served on the scientific advisory board for Geneoscopy.
, prospective pooled data from two Scandinavian birth cohorts suggested.
It appears important to feed children a quality diet at a very young age, in particular one rich in vegetables and fish, since by age three, only dietary fish intake had any impact on IBD risk.
Although high intakes of these two food categories in very early life correlated with lower IBD risk, exposure to sugar-sweetened beverages (SSBs) was associated with an increased risk. “While non-causal explanations for our results cannot be ruled out, these novel findings are consistent with the hypothesis that early-life diet, possibly mediated through changes in the gut microbiome, may affect the risk of developing IBD,” wrote lead author Annie Guo, a PhD candidate in the Department of Pediatrics, University of Gothenburg, Sweden, and colleagues. The report was published in Gut.
“This is a population-based study investigating the risk for IBD, rather than the specific effect of diet,” Ms. Guo said in an interview. “Therefore, the results are not enough on their own to be translated into individual advice that can be applicable in the clinic. However, the study supports current dietary guidelines for small children, that is, the intake of sugar should be limited and a higher intake of fish and vegetables is beneficial for overall health.”
Two-Cohort Study
The investigators prospectively recorded food-group information on children (just under half were female) from the All Babies in Southeast Sweden and The Norwegian Mother, Father and Child Cohort Study to assess the diet quality using a Healthy Eating Index and intake frequency. Parents answered questions about their offspring’s diet at ages 12-18 months and 30-36 months. Quality of diet was measured by intake of meat, fish, fruit, vegetables, dairy, sweets, snacks, and drinks.
The Swedish cohort included 21,700 children born between October 1997 and October 1999, while the Norwegian analysis included 114,500 children, 95,200 mothers, and 75,200 fathers recruited from across Norway from 1999 to 2008. In 1,304,433 person-years of follow-up, the researchers tracked 81,280 participants from birth to childhood and adolescence, with median follow-ups in the two cohorts ranging from 1 year of age to 21.3 years (Sweden) and to 15.2 years of age (Norway). Of these children, 307 were diagnosed with IBD: Crohn’s disease (CD; n = 131); ulcerative colitis (UC; n = 97); and IBD unclassified (n = 79).
Adjusting for parental IBD history, sex, origin, education, and maternal comorbidities, the study found:
- Compared with low-quality diet, both medium- and high-quality diets at 1 year were associated with a roughly 25% reduced risk for IBD (pooled adjusted hazard ratio [aHR], 0.75 [95% CI, 0.58-0.98] and 0.75 [0.56-1.0], respectively).
- The pooled aHR per increase of category was 0.86 (95% CI, 0.74-0.99). The pooled aHR for IBD in 1-year-olds with high vs low fish intake was 0.70 (95% CI, 0.49-1.0), and this diet showed an association with a reduced risk for UC (pooled aHR, 0.46; 95% CI, 0.21-0.99). Higher vegetable intake at 1 year was also associated with a risk reduction in IBD (HR, 0.72; 95% CI, 0.55-0.95). It has been hypothesized that intake of vegetables and vegetable fibers may have programming effects on the immune system.
- AutoWith 72% of children reportedly consuming SSBs at age 1, pooled aHRs showed that some vs no intake of SSBs was associated with an increased risk for later IBD (pooled aHR, 1.42; 95% CI, 1.05-1.90).
- There were no obvious associations between overall IBD or CD/UC risk and meat, dairy, fruit, grains, potatoes, and foods high in sugar and/or fat. Diet at age 3 years was not associated with incident IBD (pooled aHR, 1.02; 95% CI, 0.76-1.37), suggesting that the risk impact of diet is greatest on very young and vulnerable microbiomes.
Ms. Guo noted that a Swedish national survey among 4-year-olds found a mean SSB consumption of 187 g/d with a mean frequency of once daily. The most desired changes in food habits are a lower intake of soft drinks, sweets, crisps, cakes, and biscuits and an increase in the intake of fruits and vegetables. A similar Norwegian survey among 2-year-olds showed that SSBs were consumed by 36% of all children with a mean intake of 40 g/d.
The exact mechanism by which sugar affects the intestinal microbiota is not established. “However, what we do know is that an excessive intake of sugar can disrupt the balance of the gut microbiome,” Ms. Guo said. “And if the child has a high intake of foods with high in sugar, that also increases the chances that the child’s overall diet has a lower intake of other foods that contribute to a diverse microbiome such as fruits and vegetables.”
An ‘Elegant’ Study
In an accompanying editorial, gastroenterologist Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, of Mass General Brigham and the Mass General Research Institute, Boston, cautioned that accurately measuring food intake in very young children is difficult, and dietary questionnaires in this study did not address food additives and emulsifiers common in commercial baby food, which may play a role in the pathogenesis of IBD.
Another study limitation is that the dietary questionnaire used has not been qualitatively or quantitatively validated against other more conventional methods, said Dr. Ananthakrishnan, who was not involved in the research.
Nevertheless, he called the study “elegant” and expanding of the data on the importance of this period in IBD development. “Although in the present study there was no association between diet at 3 years and development of IBD (in contrast to the association observed for dietary intake at 1 year), other prospective cohorts of adult-onset IBD have demonstrated an inverse association between vegetable or fish intake and reduced risk for CD while sugar-sweetened beverages have been linked to a higher risk for IBD.”
As to the question of recommending early preventive diet for IBD, “thus far, data on the impact of diet very early in childhood, outside of breastfeeding, on the risk for IBD has been lacking,” Dr. Ananthakrishnan said in an interview. “This important study highlights that diet as early as 1 year can modify subsequent risk for IBD. This raises the intriguing possibility of whether early changes in diet could be used, particularly in those at higher risk, to reduce or even prevent future development of IBD. Of course, more works needs to be done to define modifiability of diet as a risk factor, but this is an important supportive data.”
In his editorial, Dr. Ananthakrishnan stated that despite the absence of gold-standard interventional data demonstrating a benefit of dietary interventions, “in my opinion, it may still be reasonable to suggest such interventions to motivate individuals who incorporate several of the dietary patterns associated with lower risk for IBD from this and other studies. This includes ensuring adequate dietary fiber, particularly from fruits and vegetables, intake of fish, minimizing sugar-sweetened beverages and preferring fresh over processed and ultra-processed foods and snacks.” According to the study authors, their novel findings support further research on the role of childhood diet in the prevention of IBD.
The All Babies in Southeast Sweden Study is supported by Barndiabetesfonden (Swedish Child Diabetes Foundation), the Swedish Council for Working Life and Social Research, the Swedish Research Council, the Medical Research Council of Southeast Sweden, the JDRF Wallenberg Foundation, ALF and LFoU grants from Region Östergötland and Linköping University, and the Joanna Cocozza Foundation.
The Norwegian Mother, Father and Child Cohort Study is supported by the Norwegian Ministry of Health and Care Services and the Ministry of Education and Research.
Ms. Guo received grants from the Swedish Society for Medical Research and the Henning and Johan Throne-Holst Foundation to conduct this study. Co-author Karl Mårild has received funding from the Swedish Society for Medical Research, the Swedish Research Council, and ALF, Sweden’s medical research and education co-ordinating body. The authors declared no competing interests. Dr. Ananthakrishnan is supported by the National Institutes of Health, the Leona M. and Harry B. Helmsley Charitable Trust, and the Chleck Family Foundation. He has served on the scientific advisory board for Geneoscopy.
FROM GUT
The Inconsistency of Preparticipation Sports Evaluations Raises Issues About Their Utility
TORONTO — There is little consistency in the elements and types of information captured in preparticipation physical evaluations (PPE) for sports among school-aged children, which is complicating efforts to determine if they have value, according to a study presented at the Pediatric Academic Societies annual meeting.
The study concept developed when Tammy Ng, MD, a third-year resident in pediatrics at the University of California, Davis, School of Medicine in Sacramento, was surprised to learn that the American Academy of Pediatrics (AAP) had been issuing a standard-of-care PPE for decades.
Dr. Ng had a long-standing interest in pediatric sports medicine and thought that if she was unfamiliar with this form, which was first developed by the AAP in the 1990s in collaboration with other professional organizations, there must be others who were unaware of this resource.
Assuming that this collaborative effort led by the AAP could serve as a standard of care, Dr. Ng evaluated whether PPEs at her own institution were capturing similar information.
In the most recent (5th) edition of the PPE, which was released in 2019 and is available online, medical history is elicited for numerous organ systems relevant to risk. The questions are not directed to any specific sport; the form does not even provide a question about which sports are being considered.
Little Consistency
In evaluating whether PPEs completed at her institution in the previous year elicited similar information, Dr. Ng sought to match 25 elements of patient history from the AAP form to questions posed in the PPEs completed at her institution, some of which had been supplied by school or sports organizations.
Of the 365 PPE forms completed at Dr. Ng’s institution that met study criteria, only 28.6% addressed all 25 elements in the AAP form (range, 0%-78%). Although more than half asked specifically about a history of respiratory symptoms, fewer than half included inquiries about cardiovascular history. There was also little consistency in the capture of information about other relevant medical history.
According to Dr. Ng, these low percentages were observed even when liberally awarding credit. For one example, she said forms that asked any question about syncope with exercise were credited with seeking information about cardiovascular health even though a yes-or-no response might not be helpful.
“We did not distinguish between syncope before or after exercise and this is relevant,” Dr. Ng said. “Syncope during exercise is more likely to be a predictor of sudden cardiac death, whereas syncope after exercise is more likely to be a vasovagal response to exertion.”
Of the 365 PPEs evaluated, about half were completed by pediatricians and half by family medicine clinicians. The average age of the children was about 14 years. Sixty-three percent were male. Only one third of the forms documented the sport for which a pre-participation screen was being submitted.
While almost all states now require PPEs for children considering participation in sports, few specify what information should be elicited, according to Dr. Ng. She further noted that no major study has shown that PPEs have any role in preventing morbidity or mortality related to sports participation.
Does Heterogeneity Negate Worth?
With such diversity across PPEs, evaluating their role is difficult. For example, with such heterogeneity among forms for the information elicited, there is no reasonable approach for testing their sensitivity in predicting medical complications.
Dr. Ng noted that school-created forms were just as likely as forms from other sources to diverge from the AAP-endorsed PPE and ignore organ systems relevant to risk of medical complications. Yet, if the answer is to use the AAP form, Dr. Ng noted that the first sentence on the form reads, “This form should be placed in the athlete’s medical file and should not be shared with schools or sports organizations.”
Although Dr. Ng acknowledged that providing completed PPEs to third parties raises questions about privacy, she questioned how the information should be used by children, parents, and sports organization administrators for discussing risks if not shared.
This concern was seconded in the discussion following Dr. Ng’s presentation.
“You might be signing off on sports participation, but is this for cheerleading or for football?” asked Daniel C. Worthington, MD, a pediatrician in private practice who has a clinical appointment at Case Western Reserve University School of Medicine, Cleveland. “This makes a huge difference when evaluating if participation is safe.”
He has no issue with completing PPEs for the goal of keeping children safe, but he focused on the inconsistency of how information is collected and distributed.
“The major question is: Does it make any difference?” said Dr. Worthington, referring to the completion of PPEs.
Another participant in the discussion that followed Dr. Ng’s presentation pointed out that the urgent care office in a mall near to his office offers a completed PPE form for a price of $20. In their recommendations, the AAP suggests PPEs be completed by the individual’s primary care physician during a well visit, according to Dr. Ng.
Dr. Ng indicated that PPEs and their purpose deserve a closer look. Based on her data, it is reasonable to assume that the priority for some – whether those requiring or those completing the form — is completing the task rather than meaningful screening of risk.
Dr. Ng and Dr. Worthington report no potential conflicts of interest.
TORONTO — There is little consistency in the elements and types of information captured in preparticipation physical evaluations (PPE) for sports among school-aged children, which is complicating efforts to determine if they have value, according to a study presented at the Pediatric Academic Societies annual meeting.
The study concept developed when Tammy Ng, MD, a third-year resident in pediatrics at the University of California, Davis, School of Medicine in Sacramento, was surprised to learn that the American Academy of Pediatrics (AAP) had been issuing a standard-of-care PPE for decades.
Dr. Ng had a long-standing interest in pediatric sports medicine and thought that if she was unfamiliar with this form, which was first developed by the AAP in the 1990s in collaboration with other professional organizations, there must be others who were unaware of this resource.
Assuming that this collaborative effort led by the AAP could serve as a standard of care, Dr. Ng evaluated whether PPEs at her own institution were capturing similar information.
In the most recent (5th) edition of the PPE, which was released in 2019 and is available online, medical history is elicited for numerous organ systems relevant to risk. The questions are not directed to any specific sport; the form does not even provide a question about which sports are being considered.
Little Consistency
In evaluating whether PPEs completed at her institution in the previous year elicited similar information, Dr. Ng sought to match 25 elements of patient history from the AAP form to questions posed in the PPEs completed at her institution, some of which had been supplied by school or sports organizations.
Of the 365 PPE forms completed at Dr. Ng’s institution that met study criteria, only 28.6% addressed all 25 elements in the AAP form (range, 0%-78%). Although more than half asked specifically about a history of respiratory symptoms, fewer than half included inquiries about cardiovascular history. There was also little consistency in the capture of information about other relevant medical history.
According to Dr. Ng, these low percentages were observed even when liberally awarding credit. For one example, she said forms that asked any question about syncope with exercise were credited with seeking information about cardiovascular health even though a yes-or-no response might not be helpful.
“We did not distinguish between syncope before or after exercise and this is relevant,” Dr. Ng said. “Syncope during exercise is more likely to be a predictor of sudden cardiac death, whereas syncope after exercise is more likely to be a vasovagal response to exertion.”
Of the 365 PPEs evaluated, about half were completed by pediatricians and half by family medicine clinicians. The average age of the children was about 14 years. Sixty-three percent were male. Only one third of the forms documented the sport for which a pre-participation screen was being submitted.
While almost all states now require PPEs for children considering participation in sports, few specify what information should be elicited, according to Dr. Ng. She further noted that no major study has shown that PPEs have any role in preventing morbidity or mortality related to sports participation.
Does Heterogeneity Negate Worth?
With such diversity across PPEs, evaluating their role is difficult. For example, with such heterogeneity among forms for the information elicited, there is no reasonable approach for testing their sensitivity in predicting medical complications.
Dr. Ng noted that school-created forms were just as likely as forms from other sources to diverge from the AAP-endorsed PPE and ignore organ systems relevant to risk of medical complications. Yet, if the answer is to use the AAP form, Dr. Ng noted that the first sentence on the form reads, “This form should be placed in the athlete’s medical file and should not be shared with schools or sports organizations.”
Although Dr. Ng acknowledged that providing completed PPEs to third parties raises questions about privacy, she questioned how the information should be used by children, parents, and sports organization administrators for discussing risks if not shared.
This concern was seconded in the discussion following Dr. Ng’s presentation.
“You might be signing off on sports participation, but is this for cheerleading or for football?” asked Daniel C. Worthington, MD, a pediatrician in private practice who has a clinical appointment at Case Western Reserve University School of Medicine, Cleveland. “This makes a huge difference when evaluating if participation is safe.”
He has no issue with completing PPEs for the goal of keeping children safe, but he focused on the inconsistency of how information is collected and distributed.
“The major question is: Does it make any difference?” said Dr. Worthington, referring to the completion of PPEs.
Another participant in the discussion that followed Dr. Ng’s presentation pointed out that the urgent care office in a mall near to his office offers a completed PPE form for a price of $20. In their recommendations, the AAP suggests PPEs be completed by the individual’s primary care physician during a well visit, according to Dr. Ng.
Dr. Ng indicated that PPEs and their purpose deserve a closer look. Based on her data, it is reasonable to assume that the priority for some – whether those requiring or those completing the form — is completing the task rather than meaningful screening of risk.
Dr. Ng and Dr. Worthington report no potential conflicts of interest.
TORONTO — There is little consistency in the elements and types of information captured in preparticipation physical evaluations (PPE) for sports among school-aged children, which is complicating efforts to determine if they have value, according to a study presented at the Pediatric Academic Societies annual meeting.
The study concept developed when Tammy Ng, MD, a third-year resident in pediatrics at the University of California, Davis, School of Medicine in Sacramento, was surprised to learn that the American Academy of Pediatrics (AAP) had been issuing a standard-of-care PPE for decades.
Dr. Ng had a long-standing interest in pediatric sports medicine and thought that if she was unfamiliar with this form, which was first developed by the AAP in the 1990s in collaboration with other professional organizations, there must be others who were unaware of this resource.
Assuming that this collaborative effort led by the AAP could serve as a standard of care, Dr. Ng evaluated whether PPEs at her own institution were capturing similar information.
In the most recent (5th) edition of the PPE, which was released in 2019 and is available online, medical history is elicited for numerous organ systems relevant to risk. The questions are not directed to any specific sport; the form does not even provide a question about which sports are being considered.
Little Consistency
In evaluating whether PPEs completed at her institution in the previous year elicited similar information, Dr. Ng sought to match 25 elements of patient history from the AAP form to questions posed in the PPEs completed at her institution, some of which had been supplied by school or sports organizations.
Of the 365 PPE forms completed at Dr. Ng’s institution that met study criteria, only 28.6% addressed all 25 elements in the AAP form (range, 0%-78%). Although more than half asked specifically about a history of respiratory symptoms, fewer than half included inquiries about cardiovascular history. There was also little consistency in the capture of information about other relevant medical history.
According to Dr. Ng, these low percentages were observed even when liberally awarding credit. For one example, she said forms that asked any question about syncope with exercise were credited with seeking information about cardiovascular health even though a yes-or-no response might not be helpful.
“We did not distinguish between syncope before or after exercise and this is relevant,” Dr. Ng said. “Syncope during exercise is more likely to be a predictor of sudden cardiac death, whereas syncope after exercise is more likely to be a vasovagal response to exertion.”
Of the 365 PPEs evaluated, about half were completed by pediatricians and half by family medicine clinicians. The average age of the children was about 14 years. Sixty-three percent were male. Only one third of the forms documented the sport for which a pre-participation screen was being submitted.
While almost all states now require PPEs for children considering participation in sports, few specify what information should be elicited, according to Dr. Ng. She further noted that no major study has shown that PPEs have any role in preventing morbidity or mortality related to sports participation.
Does Heterogeneity Negate Worth?
With such diversity across PPEs, evaluating their role is difficult. For example, with such heterogeneity among forms for the information elicited, there is no reasonable approach for testing their sensitivity in predicting medical complications.
Dr. Ng noted that school-created forms were just as likely as forms from other sources to diverge from the AAP-endorsed PPE and ignore organ systems relevant to risk of medical complications. Yet, if the answer is to use the AAP form, Dr. Ng noted that the first sentence on the form reads, “This form should be placed in the athlete’s medical file and should not be shared with schools or sports organizations.”
Although Dr. Ng acknowledged that providing completed PPEs to third parties raises questions about privacy, she questioned how the information should be used by children, parents, and sports organization administrators for discussing risks if not shared.
This concern was seconded in the discussion following Dr. Ng’s presentation.
“You might be signing off on sports participation, but is this for cheerleading or for football?” asked Daniel C. Worthington, MD, a pediatrician in private practice who has a clinical appointment at Case Western Reserve University School of Medicine, Cleveland. “This makes a huge difference when evaluating if participation is safe.”
He has no issue with completing PPEs for the goal of keeping children safe, but he focused on the inconsistency of how information is collected and distributed.
“The major question is: Does it make any difference?” said Dr. Worthington, referring to the completion of PPEs.
Another participant in the discussion that followed Dr. Ng’s presentation pointed out that the urgent care office in a mall near to his office offers a completed PPE form for a price of $20. In their recommendations, the AAP suggests PPEs be completed by the individual’s primary care physician during a well visit, according to Dr. Ng.
Dr. Ng indicated that PPEs and their purpose deserve a closer look. Based on her data, it is reasonable to assume that the priority for some – whether those requiring or those completing the form — is completing the task rather than meaningful screening of risk.
Dr. Ng and Dr. Worthington report no potential conflicts of interest.
FROM PAS 2024
Neutrophils Take Center Stage in Growing Understanding of Colchicine’s Role in Treating Atherosclerotic Cardiovascular Disease
NEW YORK — New insights into colchicine’s disruption of the pathway that contributes to arterial inflammation and new clinical studies of the drug could pave the way toward greater use of the anti-inflammatory drug in patients with or at risk for atherosclerotic cardiovascular disease (ASCVD), researchers said at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
Colchicine was approved by the US Food and Drug Administration (FDA) in June 2023 in a once-daily 0.5-mg formulation under the brand name Lodoco to reduce the risk for major adverse cardiovascular events (MACE) in patients with established atherosclerotic disease or with multiple risk factors for CVD. The Lodoco formulation is slightly smaller than the 0.6-mg formulation that’s taken twice daily for the prophylaxis and treatment of acute gout flares.
In a presentation at the conference, Binita Shah, MD, one of the principal investigators in trials of Lodoco, explained how the inflammatory pathway contributes to atherosclerosis and provided an update on how colchicine disrupts the pathway. Dr. Shah is an associate professor of medicine at New York University in New York City and director of research at NYU Langone Health Interventional Cardiology.
“Colchicine dampens inflammatory markers on neutrophils so that they are less likely to be attracted to inflamed or injured endothelium, which would be the site of where plaque is building up or where the plaque has ruptured in the setting of a heart attack,” Shah told this news organization after her presentation.
The Inflammatory Pathway
Dr. Shah explained that normal coronary endothelium resists adhesion by circulating leukocytes, but inflamed or injured coronary endothelium attracts those neutrophils via two types of selectins: L-selectins on neutrophils and E-selectins on endothelial cells. Those neutrophils then release inflammatory cytokines including interleukin-1 beta (IL-1ß), which then triggers production of IL-6 and, subsequently, high-sensitivity C-reactive protein (hsCRP), which contributes to plaque formation, she said.
“Colchicine affects these pathways with a balance for safety and effect on clinical outcomes, particularly to reduce recurrent myocardial infarction [MI],” Dr. Shah said during her presentation.
Results from the CIRT trial demonstrated that methotrexate is ineffective in blocking the adenosine-mediated anti-inflammatory pathway, Dr. Shah said, so focusing on the IL-1ß–IL-6–hsCRP pathway, which is known to work based on the results of the CANTOS trial, could pay dividends.
“This is where colchicine can potentially play a role,” she said.
Dr. Shah cited a secondary analysis of the CANTOS trial in which the magnitude of hsCRP reduction correlated with a reduction in MI, stroke, or cardiovascular death. The secondary analysis showed that patients who received canakinumab and achieved hsCRP ≥ 2 mg/L had a nonsignificant 5% lower risk and those who reached < 2 mg/L had a statistically significant 25% lower risk than those who received placebo.
The COPE-PCI Pilot trial demonstrated the benefit of targeting the interleukin pathways, she noted.
Further clarification of the role of colchicine in managing patients with acute coronary syndrome may come from two other randomized trials now underway, Dr. Shah said: POPCORN is evaluating colchicine to reduce MACE after noncardiac surgery, and CLEAR SYNERGY is evaluating the best timing for colchicine therapy after an acute MI.
Dr. Shah presented preliminary data from her group from a neutrophil biomarker substudy of CLEAR SYNERGY that isolated neutrophils from patients who had an acute MI. “We treated them with various doses of colchicine and showed that the interaction between those treated neutrophils [and] the endothelial cells were a lot lower; they were less sticky to endothelial cells as colchicine was administered,” she said in her presentation. She added that colchicine also reduced neutrophil chemotaxis and neutrophil activation and potentially inhibited inflammasomes, decreasing IL-1ß production.
What’s more, colchicine has been shown to not affect platelets alone but rather platelets at the site of inflammation or plaque rupture, Dr. Shah added. “At currently used doses, colchicine does not inhibit platelet activity [by] itself, so we’ve never seen increased bleeding events, but it will dampen neutrophils’ ability to latch onto a platelet that could contribute to a clot,” she later told this news organization.
“There are multiple studies, both retrospective studies in gout cohorts as well as prospective studies in the cardiovascular cohort, that all show consistently one thing, which is that colchicine continues to reduce the risk of having a recurrent MI in patients who either have cardiovascular disease or are at high risk of having cardiovascular disease,” she said.
“I think that’s very helpful to know that it’s not just one study — it’s not just a fluke, potentially a play of chance — but multiple studies consistently showing the same thing: That there’s a reduced risk of acute MI.”
Slow to Embrace Colchicine
Despite this evidence, cardiologists and rheumatologists have been slow to embrace colchicine for patients at risk for cardiovascular events, said Michael S. Garshick, MD, who attended the conference and is head of the Cardio-Rheumatology Program at NYU Langone. “What [Shah] really highlighted was that for a number of years now, we’ve had several clinical trials showing the benefit of low-dose colchicine to prevent atherosclerotic cardiovascular events, and yet despite these and that there’s now an indication to use low-dose colchicine to reduce cardiovascular disease, we’re still struggling for this medication to be taken up by the general cardiology community to treat high-risk patients.
“There’s still some work to do to prove that we need to break those barriers,” Dr. Garshick added. Some of the confusion surrounding the use of colchicine for ASCVD may be attributed to the 0.5-mg dose approved for CVD as opposed to the long-approved 0.6-mg dose for gout, he said. “People are generally confused: Is it OK to use the 0.6-mg dose?” Dr. Garshick said.
Potential gastrointestinal side effects may be another concerning factor, although, he added, “we didn’t see any major complications.” Another issue could be polypharmacy in many of these patients, he said.
Dr. Garshick concurred with Shah that the existing evidence supporting the use of colchicine to reduce risk for cardiovascular events is strong, but more will come out. “I think there’s going to be evolving data supporting it,” he said.
Dr. Shah disclosed financial relationships with Philips Volcano and Novo Nordisk. She is a principal investigator of the CLEAR SYNERGY biomarker substudy and the POPCORN trial. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.
A version of this article appeared on Medscape.com .
NEW YORK — New insights into colchicine’s disruption of the pathway that contributes to arterial inflammation and new clinical studies of the drug could pave the way toward greater use of the anti-inflammatory drug in patients with or at risk for atherosclerotic cardiovascular disease (ASCVD), researchers said at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
Colchicine was approved by the US Food and Drug Administration (FDA) in June 2023 in a once-daily 0.5-mg formulation under the brand name Lodoco to reduce the risk for major adverse cardiovascular events (MACE) in patients with established atherosclerotic disease or with multiple risk factors for CVD. The Lodoco formulation is slightly smaller than the 0.6-mg formulation that’s taken twice daily for the prophylaxis and treatment of acute gout flares.
In a presentation at the conference, Binita Shah, MD, one of the principal investigators in trials of Lodoco, explained how the inflammatory pathway contributes to atherosclerosis and provided an update on how colchicine disrupts the pathway. Dr. Shah is an associate professor of medicine at New York University in New York City and director of research at NYU Langone Health Interventional Cardiology.
“Colchicine dampens inflammatory markers on neutrophils so that they are less likely to be attracted to inflamed or injured endothelium, which would be the site of where plaque is building up or where the plaque has ruptured in the setting of a heart attack,” Shah told this news organization after her presentation.
The Inflammatory Pathway
Dr. Shah explained that normal coronary endothelium resists adhesion by circulating leukocytes, but inflamed or injured coronary endothelium attracts those neutrophils via two types of selectins: L-selectins on neutrophils and E-selectins on endothelial cells. Those neutrophils then release inflammatory cytokines including interleukin-1 beta (IL-1ß), which then triggers production of IL-6 and, subsequently, high-sensitivity C-reactive protein (hsCRP), which contributes to plaque formation, she said.
“Colchicine affects these pathways with a balance for safety and effect on clinical outcomes, particularly to reduce recurrent myocardial infarction [MI],” Dr. Shah said during her presentation.
Results from the CIRT trial demonstrated that methotrexate is ineffective in blocking the adenosine-mediated anti-inflammatory pathway, Dr. Shah said, so focusing on the IL-1ß–IL-6–hsCRP pathway, which is known to work based on the results of the CANTOS trial, could pay dividends.
“This is where colchicine can potentially play a role,” she said.
Dr. Shah cited a secondary analysis of the CANTOS trial in which the magnitude of hsCRP reduction correlated with a reduction in MI, stroke, or cardiovascular death. The secondary analysis showed that patients who received canakinumab and achieved hsCRP ≥ 2 mg/L had a nonsignificant 5% lower risk and those who reached < 2 mg/L had a statistically significant 25% lower risk than those who received placebo.
The COPE-PCI Pilot trial demonstrated the benefit of targeting the interleukin pathways, she noted.
Further clarification of the role of colchicine in managing patients with acute coronary syndrome may come from two other randomized trials now underway, Dr. Shah said: POPCORN is evaluating colchicine to reduce MACE after noncardiac surgery, and CLEAR SYNERGY is evaluating the best timing for colchicine therapy after an acute MI.
Dr. Shah presented preliminary data from her group from a neutrophil biomarker substudy of CLEAR SYNERGY that isolated neutrophils from patients who had an acute MI. “We treated them with various doses of colchicine and showed that the interaction between those treated neutrophils [and] the endothelial cells were a lot lower; they were less sticky to endothelial cells as colchicine was administered,” she said in her presentation. She added that colchicine also reduced neutrophil chemotaxis and neutrophil activation and potentially inhibited inflammasomes, decreasing IL-1ß production.
What’s more, colchicine has been shown to not affect platelets alone but rather platelets at the site of inflammation or plaque rupture, Dr. Shah added. “At currently used doses, colchicine does not inhibit platelet activity [by] itself, so we’ve never seen increased bleeding events, but it will dampen neutrophils’ ability to latch onto a platelet that could contribute to a clot,” she later told this news organization.
“There are multiple studies, both retrospective studies in gout cohorts as well as prospective studies in the cardiovascular cohort, that all show consistently one thing, which is that colchicine continues to reduce the risk of having a recurrent MI in patients who either have cardiovascular disease or are at high risk of having cardiovascular disease,” she said.
“I think that’s very helpful to know that it’s not just one study — it’s not just a fluke, potentially a play of chance — but multiple studies consistently showing the same thing: That there’s a reduced risk of acute MI.”
Slow to Embrace Colchicine
Despite this evidence, cardiologists and rheumatologists have been slow to embrace colchicine for patients at risk for cardiovascular events, said Michael S. Garshick, MD, who attended the conference and is head of the Cardio-Rheumatology Program at NYU Langone. “What [Shah] really highlighted was that for a number of years now, we’ve had several clinical trials showing the benefit of low-dose colchicine to prevent atherosclerotic cardiovascular events, and yet despite these and that there’s now an indication to use low-dose colchicine to reduce cardiovascular disease, we’re still struggling for this medication to be taken up by the general cardiology community to treat high-risk patients.
“There’s still some work to do to prove that we need to break those barriers,” Dr. Garshick added. Some of the confusion surrounding the use of colchicine for ASCVD may be attributed to the 0.5-mg dose approved for CVD as opposed to the long-approved 0.6-mg dose for gout, he said. “People are generally confused: Is it OK to use the 0.6-mg dose?” Dr. Garshick said.
Potential gastrointestinal side effects may be another concerning factor, although, he added, “we didn’t see any major complications.” Another issue could be polypharmacy in many of these patients, he said.
Dr. Garshick concurred with Shah that the existing evidence supporting the use of colchicine to reduce risk for cardiovascular events is strong, but more will come out. “I think there’s going to be evolving data supporting it,” he said.
Dr. Shah disclosed financial relationships with Philips Volcano and Novo Nordisk. She is a principal investigator of the CLEAR SYNERGY biomarker substudy and the POPCORN trial. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.
A version of this article appeared on Medscape.com .
NEW YORK — New insights into colchicine’s disruption of the pathway that contributes to arterial inflammation and new clinical studies of the drug could pave the way toward greater use of the anti-inflammatory drug in patients with or at risk for atherosclerotic cardiovascular disease (ASCVD), researchers said at the 4th Annual Cardiometabolic Risk in Inflammatory Conditions conference.
Colchicine was approved by the US Food and Drug Administration (FDA) in June 2023 in a once-daily 0.5-mg formulation under the brand name Lodoco to reduce the risk for major adverse cardiovascular events (MACE) in patients with established atherosclerotic disease or with multiple risk factors for CVD. The Lodoco formulation is slightly smaller than the 0.6-mg formulation that’s taken twice daily for the prophylaxis and treatment of acute gout flares.
In a presentation at the conference, Binita Shah, MD, one of the principal investigators in trials of Lodoco, explained how the inflammatory pathway contributes to atherosclerosis and provided an update on how colchicine disrupts the pathway. Dr. Shah is an associate professor of medicine at New York University in New York City and director of research at NYU Langone Health Interventional Cardiology.
“Colchicine dampens inflammatory markers on neutrophils so that they are less likely to be attracted to inflamed or injured endothelium, which would be the site of where plaque is building up or where the plaque has ruptured in the setting of a heart attack,” Shah told this news organization after her presentation.
The Inflammatory Pathway
Dr. Shah explained that normal coronary endothelium resists adhesion by circulating leukocytes, but inflamed or injured coronary endothelium attracts those neutrophils via two types of selectins: L-selectins on neutrophils and E-selectins on endothelial cells. Those neutrophils then release inflammatory cytokines including interleukin-1 beta (IL-1ß), which then triggers production of IL-6 and, subsequently, high-sensitivity C-reactive protein (hsCRP), which contributes to plaque formation, she said.
“Colchicine affects these pathways with a balance for safety and effect on clinical outcomes, particularly to reduce recurrent myocardial infarction [MI],” Dr. Shah said during her presentation.
Results from the CIRT trial demonstrated that methotrexate is ineffective in blocking the adenosine-mediated anti-inflammatory pathway, Dr. Shah said, so focusing on the IL-1ß–IL-6–hsCRP pathway, which is known to work based on the results of the CANTOS trial, could pay dividends.
“This is where colchicine can potentially play a role,” she said.
Dr. Shah cited a secondary analysis of the CANTOS trial in which the magnitude of hsCRP reduction correlated with a reduction in MI, stroke, or cardiovascular death. The secondary analysis showed that patients who received canakinumab and achieved hsCRP ≥ 2 mg/L had a nonsignificant 5% lower risk and those who reached < 2 mg/L had a statistically significant 25% lower risk than those who received placebo.
The COPE-PCI Pilot trial demonstrated the benefit of targeting the interleukin pathways, she noted.
Further clarification of the role of colchicine in managing patients with acute coronary syndrome may come from two other randomized trials now underway, Dr. Shah said: POPCORN is evaluating colchicine to reduce MACE after noncardiac surgery, and CLEAR SYNERGY is evaluating the best timing for colchicine therapy after an acute MI.
Dr. Shah presented preliminary data from her group from a neutrophil biomarker substudy of CLEAR SYNERGY that isolated neutrophils from patients who had an acute MI. “We treated them with various doses of colchicine and showed that the interaction between those treated neutrophils [and] the endothelial cells were a lot lower; they were less sticky to endothelial cells as colchicine was administered,” she said in her presentation. She added that colchicine also reduced neutrophil chemotaxis and neutrophil activation and potentially inhibited inflammasomes, decreasing IL-1ß production.
What’s more, colchicine has been shown to not affect platelets alone but rather platelets at the site of inflammation or plaque rupture, Dr. Shah added. “At currently used doses, colchicine does not inhibit platelet activity [by] itself, so we’ve never seen increased bleeding events, but it will dampen neutrophils’ ability to latch onto a platelet that could contribute to a clot,” she later told this news organization.
“There are multiple studies, both retrospective studies in gout cohorts as well as prospective studies in the cardiovascular cohort, that all show consistently one thing, which is that colchicine continues to reduce the risk of having a recurrent MI in patients who either have cardiovascular disease or are at high risk of having cardiovascular disease,” she said.
“I think that’s very helpful to know that it’s not just one study — it’s not just a fluke, potentially a play of chance — but multiple studies consistently showing the same thing: That there’s a reduced risk of acute MI.”
Slow to Embrace Colchicine
Despite this evidence, cardiologists and rheumatologists have been slow to embrace colchicine for patients at risk for cardiovascular events, said Michael S. Garshick, MD, who attended the conference and is head of the Cardio-Rheumatology Program at NYU Langone. “What [Shah] really highlighted was that for a number of years now, we’ve had several clinical trials showing the benefit of low-dose colchicine to prevent atherosclerotic cardiovascular events, and yet despite these and that there’s now an indication to use low-dose colchicine to reduce cardiovascular disease, we’re still struggling for this medication to be taken up by the general cardiology community to treat high-risk patients.
“There’s still some work to do to prove that we need to break those barriers,” Dr. Garshick added. Some of the confusion surrounding the use of colchicine for ASCVD may be attributed to the 0.5-mg dose approved for CVD as opposed to the long-approved 0.6-mg dose for gout, he said. “People are generally confused: Is it OK to use the 0.6-mg dose?” Dr. Garshick said.
Potential gastrointestinal side effects may be another concerning factor, although, he added, “we didn’t see any major complications.” Another issue could be polypharmacy in many of these patients, he said.
Dr. Garshick concurred with Shah that the existing evidence supporting the use of colchicine to reduce risk for cardiovascular events is strong, but more will come out. “I think there’s going to be evolving data supporting it,” he said.
Dr. Shah disclosed financial relationships with Philips Volcano and Novo Nordisk. She is a principal investigator of the CLEAR SYNERGY biomarker substudy and the POPCORN trial. Dr. Garshick disclosed relationships with Kiniksa Pharmaceuticals, Agepha Pharma, Bristol Myers Squibb, and Horizon Therapeutics.
A version of this article appeared on Medscape.com .
Do Health-Related Social Needs Raise Mortality Risk in Cancer Survivors?
Little is known about the specific association between health-related social needs (HRSNs) and mortality risk even though HRSNs, defined as challenges in affording food, housing, and other necessities of daily living, are potential challenges for cancer survivors, wrote Zhiyuan Zheng, PhD, of the American Cancer Society, Atlanta, and colleagues.
A 2020 study by Dr. Zheng and colleagues published in the Journal of the National Comprehensive Cancer Network (NCCN) showed that food insecurity and financial worries had a negative impact on cancer survivorship. In the new study, published in Cancer, the researchers identified cancer survivors using the 2013-2018 National Health Interview Survey (NHIS) and the NHIS Mortality File through December 31, 2019. The researchers examined mortality using the data from the Centers for Disease Control and Prevention’s National Death Index (NDI) through December 31, 2019, which links to the National Health Interview Survey Data used in the study.
Individuals’ HRSNs were categorized into three groups: severe, moderate, and minor/none. HRSNs included food insecurity and nonmedical financial concerns, such as housing costs (rent, mortgage). Medical financial hardship included material, psychological, and behavioral domains and was divided into three groups: 2-3 domains, 1 domain, or 0 domains.
What Are the Potential Financial Implications of this Research?
The high costs of cancer care often cause medical financial hardships for cancer survivors, and expenses also may cause psychological distress and nonmedical financial hardship as survivors try to make ends meet while facing medical bills, wrote Dr. Zheng and colleagues.
Policy makers are increasingly interested in adding HRSNs to insurance coverage; recent guidance from the Centers for Medicare & Medicaid Services (CMS) allows individual states to apply to provide nutrition and housing supports through state Medicaid programs, according to authors of a 2023 article published in JAMA Health Forum.
The new study adds to the understanding of how HRSNs impact people with cancer by examining the association with mortality risk, Yelak Biru, MSc, president and chief executive officer of the International Myeloma Foundation, said in an interview.
“This is a key area of study for addressing the disparities in treatments and outcomes that result in inequities,” said Mr. Biru, a patient advocate and multiple myeloma survivor who was not involved in the study.
What Does the New Study Show?
The new study characterized HRSNs in 5,855 adult cancer survivors aged 18-64 years and 5,918 aged 65-79 years. In the 18- to 64-year-old group, 25.5% reported moderate levels of HRSNs, and 18.3% reported severe HRSNs. In patients aged 65-79 years, 15.6% and 6.6% reported moderate HRSNs and severe HRSNs, respectively.
Severe HRSN was significantly associated with higher mortality risk in an adjusted analysis in patients aged 18-64 years (hazard ratio 2.00, P < .001).
Among adults aged 65-79 years, severe HRSN was not associated with higher mortality risk; however, in this older age group, those with 2-3 domains of medical financial hardship had significantly increased mortality risk compared with adults aged 65-79 years with zero domains of medical financial hardship (HR 1.58, P = .007).
Although the findings that HRSNs were associated with increased mortality risk, especially in the younger group, were not surprising, they serve as a call to action to address how HRSNs are contributing to cancer mortality, Mr. Biru said in an interview. “HRSNs, like food or housing insecurity, can lead to patients being unable to undergo the best treatment approach for their cancer,” he said.
What Are the Limitations and Research Gaps?
The study findings were limited by several factors including the use of self-reports to measure medical financial hardship, food insecurity, and nonmedical financial concerns in the NHIS, the researchers wrote in their discussion. More research with longer follow-up time beyond 1-5 years is needed, wrote Dr. Zheng and colleagues.
Studies also are needed to illustrate how patient navigation can help prevent patients from falling through the cracks with regard to social needs and financial hardships, Mr. Biru told this news organization.
Other areas for research include how addressing social needs affects health outcomes and whether programs designed to address social needs are effective, he said.
“Finally, qualitative research is needed to capture the lived experiences of cancer survivors facing these challenges. This knowledge can inform the development of more patient-centered interventions and policies that effectively address the social determinants of health and improve overall outcomes for all cancer survivors,” Mr. Biru said.
What Is the Takeaway Message for Clinicians?
HRSNs and financial hardship are significantly associated with increased risk of mortality in adult cancer survivors, Dr. Zheng and colleagues concluded. Looking ahead, comprehensive assessment of HRSNs and financial hardship may help clinicians connect patients with relevant services to mitigate the social and financial impacts of cancer, they wrote.
“The takeaway message for oncologists in practice is that addressing [HRSNs] and financial hardship is crucial for providing comprehensive and equitable cancer care,” Mr. Biru said during his interview.
“The impact of social determinants of health on cancer outcomes cannot be ignored, and oncologists play a vital role in identifying and addressing these needs,” he said. Sensitive, discussion-based screenings are needed to identify core needs such as food and transportation, but clinicians also can consider broader social factors and work with a team to connect patients to appropriate resources, he added.
“By recognizing the importance of HRSN screening and taking proactive steps to address these needs, oncologists can contribute to improving health outcomes, reducing healthcare disparities, and providing more equitable cancer care for their patients,” he said.
What Other Guidance Is Available?
“High-quality cancer care requires treating the whole person; measuring and addressing anything in their life that could result in poorer health outcomes is a key component of comprehensive care,” Mr. Biru emphasized.
In September 2023, the National Comprehensive Cancer Network (NCCN) convened a working group cochaired by Mr. Biru that developed recommendations for how oncology practices should routinely measure HRSNs (NCCN.org/social-needs).
“The working group proposed that every cancer patient be assessed for food, transportation access, and financial and housing security at least once a year, and be reassessed at every care transition point as well,” Mr. Biru said. Such screenings should include follow-up to connect patients with services to address any HRSNs they are experiencing, he added.
Lead author Dr. Zheng is employed by the American Cancer Society, which as a nonprofit receives funds from the public through fundraising and contributions, as well as some support from corporations and industry to support its mission programs and services. Mr. Biru had no financial conflicts to disclose.
Little is known about the specific association between health-related social needs (HRSNs) and mortality risk even though HRSNs, defined as challenges in affording food, housing, and other necessities of daily living, are potential challenges for cancer survivors, wrote Zhiyuan Zheng, PhD, of the American Cancer Society, Atlanta, and colleagues.
A 2020 study by Dr. Zheng and colleagues published in the Journal of the National Comprehensive Cancer Network (NCCN) showed that food insecurity and financial worries had a negative impact on cancer survivorship. In the new study, published in Cancer, the researchers identified cancer survivors using the 2013-2018 National Health Interview Survey (NHIS) and the NHIS Mortality File through December 31, 2019. The researchers examined mortality using the data from the Centers for Disease Control and Prevention’s National Death Index (NDI) through December 31, 2019, which links to the National Health Interview Survey Data used in the study.
Individuals’ HRSNs were categorized into three groups: severe, moderate, and minor/none. HRSNs included food insecurity and nonmedical financial concerns, such as housing costs (rent, mortgage). Medical financial hardship included material, psychological, and behavioral domains and was divided into three groups: 2-3 domains, 1 domain, or 0 domains.
What Are the Potential Financial Implications of this Research?
The high costs of cancer care often cause medical financial hardships for cancer survivors, and expenses also may cause psychological distress and nonmedical financial hardship as survivors try to make ends meet while facing medical bills, wrote Dr. Zheng and colleagues.
Policy makers are increasingly interested in adding HRSNs to insurance coverage; recent guidance from the Centers for Medicare & Medicaid Services (CMS) allows individual states to apply to provide nutrition and housing supports through state Medicaid programs, according to authors of a 2023 article published in JAMA Health Forum.
The new study adds to the understanding of how HRSNs impact people with cancer by examining the association with mortality risk, Yelak Biru, MSc, president and chief executive officer of the International Myeloma Foundation, said in an interview.
“This is a key area of study for addressing the disparities in treatments and outcomes that result in inequities,” said Mr. Biru, a patient advocate and multiple myeloma survivor who was not involved in the study.
What Does the New Study Show?
The new study characterized HRSNs in 5,855 adult cancer survivors aged 18-64 years and 5,918 aged 65-79 years. In the 18- to 64-year-old group, 25.5% reported moderate levels of HRSNs, and 18.3% reported severe HRSNs. In patients aged 65-79 years, 15.6% and 6.6% reported moderate HRSNs and severe HRSNs, respectively.
Severe HRSN was significantly associated with higher mortality risk in an adjusted analysis in patients aged 18-64 years (hazard ratio 2.00, P < .001).
Among adults aged 65-79 years, severe HRSN was not associated with higher mortality risk; however, in this older age group, those with 2-3 domains of medical financial hardship had significantly increased mortality risk compared with adults aged 65-79 years with zero domains of medical financial hardship (HR 1.58, P = .007).
Although the findings that HRSNs were associated with increased mortality risk, especially in the younger group, were not surprising, they serve as a call to action to address how HRSNs are contributing to cancer mortality, Mr. Biru said in an interview. “HRSNs, like food or housing insecurity, can lead to patients being unable to undergo the best treatment approach for their cancer,” he said.
What Are the Limitations and Research Gaps?
The study findings were limited by several factors including the use of self-reports to measure medical financial hardship, food insecurity, and nonmedical financial concerns in the NHIS, the researchers wrote in their discussion. More research with longer follow-up time beyond 1-5 years is needed, wrote Dr. Zheng and colleagues.
Studies also are needed to illustrate how patient navigation can help prevent patients from falling through the cracks with regard to social needs and financial hardships, Mr. Biru told this news organization.
Other areas for research include how addressing social needs affects health outcomes and whether programs designed to address social needs are effective, he said.
“Finally, qualitative research is needed to capture the lived experiences of cancer survivors facing these challenges. This knowledge can inform the development of more patient-centered interventions and policies that effectively address the social determinants of health and improve overall outcomes for all cancer survivors,” Mr. Biru said.
What Is the Takeaway Message for Clinicians?
HRSNs and financial hardship are significantly associated with increased risk of mortality in adult cancer survivors, Dr. Zheng and colleagues concluded. Looking ahead, comprehensive assessment of HRSNs and financial hardship may help clinicians connect patients with relevant services to mitigate the social and financial impacts of cancer, they wrote.
“The takeaway message for oncologists in practice is that addressing [HRSNs] and financial hardship is crucial for providing comprehensive and equitable cancer care,” Mr. Biru said during his interview.
“The impact of social determinants of health on cancer outcomes cannot be ignored, and oncologists play a vital role in identifying and addressing these needs,” he said. Sensitive, discussion-based screenings are needed to identify core needs such as food and transportation, but clinicians also can consider broader social factors and work with a team to connect patients to appropriate resources, he added.
“By recognizing the importance of HRSN screening and taking proactive steps to address these needs, oncologists can contribute to improving health outcomes, reducing healthcare disparities, and providing more equitable cancer care for their patients,” he said.
What Other Guidance Is Available?
“High-quality cancer care requires treating the whole person; measuring and addressing anything in their life that could result in poorer health outcomes is a key component of comprehensive care,” Mr. Biru emphasized.
In September 2023, the National Comprehensive Cancer Network (NCCN) convened a working group cochaired by Mr. Biru that developed recommendations for how oncology practices should routinely measure HRSNs (NCCN.org/social-needs).
“The working group proposed that every cancer patient be assessed for food, transportation access, and financial and housing security at least once a year, and be reassessed at every care transition point as well,” Mr. Biru said. Such screenings should include follow-up to connect patients with services to address any HRSNs they are experiencing, he added.
Lead author Dr. Zheng is employed by the American Cancer Society, which as a nonprofit receives funds from the public through fundraising and contributions, as well as some support from corporations and industry to support its mission programs and services. Mr. Biru had no financial conflicts to disclose.
Little is known about the specific association between health-related social needs (HRSNs) and mortality risk even though HRSNs, defined as challenges in affording food, housing, and other necessities of daily living, are potential challenges for cancer survivors, wrote Zhiyuan Zheng, PhD, of the American Cancer Society, Atlanta, and colleagues.
A 2020 study by Dr. Zheng and colleagues published in the Journal of the National Comprehensive Cancer Network (NCCN) showed that food insecurity and financial worries had a negative impact on cancer survivorship. In the new study, published in Cancer, the researchers identified cancer survivors using the 2013-2018 National Health Interview Survey (NHIS) and the NHIS Mortality File through December 31, 2019. The researchers examined mortality using the data from the Centers for Disease Control and Prevention’s National Death Index (NDI) through December 31, 2019, which links to the National Health Interview Survey Data used in the study.
Individuals’ HRSNs were categorized into three groups: severe, moderate, and minor/none. HRSNs included food insecurity and nonmedical financial concerns, such as housing costs (rent, mortgage). Medical financial hardship included material, psychological, and behavioral domains and was divided into three groups: 2-3 domains, 1 domain, or 0 domains.
What Are the Potential Financial Implications of this Research?
The high costs of cancer care often cause medical financial hardships for cancer survivors, and expenses also may cause psychological distress and nonmedical financial hardship as survivors try to make ends meet while facing medical bills, wrote Dr. Zheng and colleagues.
Policy makers are increasingly interested in adding HRSNs to insurance coverage; recent guidance from the Centers for Medicare & Medicaid Services (CMS) allows individual states to apply to provide nutrition and housing supports through state Medicaid programs, according to authors of a 2023 article published in JAMA Health Forum.
The new study adds to the understanding of how HRSNs impact people with cancer by examining the association with mortality risk, Yelak Biru, MSc, president and chief executive officer of the International Myeloma Foundation, said in an interview.
“This is a key area of study for addressing the disparities in treatments and outcomes that result in inequities,” said Mr. Biru, a patient advocate and multiple myeloma survivor who was not involved in the study.
What Does the New Study Show?
The new study characterized HRSNs in 5,855 adult cancer survivors aged 18-64 years and 5,918 aged 65-79 years. In the 18- to 64-year-old group, 25.5% reported moderate levels of HRSNs, and 18.3% reported severe HRSNs. In patients aged 65-79 years, 15.6% and 6.6% reported moderate HRSNs and severe HRSNs, respectively.
Severe HRSN was significantly associated with higher mortality risk in an adjusted analysis in patients aged 18-64 years (hazard ratio 2.00, P < .001).
Among adults aged 65-79 years, severe HRSN was not associated with higher mortality risk; however, in this older age group, those with 2-3 domains of medical financial hardship had significantly increased mortality risk compared with adults aged 65-79 years with zero domains of medical financial hardship (HR 1.58, P = .007).
Although the findings that HRSNs were associated with increased mortality risk, especially in the younger group, were not surprising, they serve as a call to action to address how HRSNs are contributing to cancer mortality, Mr. Biru said in an interview. “HRSNs, like food or housing insecurity, can lead to patients being unable to undergo the best treatment approach for their cancer,” he said.
What Are the Limitations and Research Gaps?
The study findings were limited by several factors including the use of self-reports to measure medical financial hardship, food insecurity, and nonmedical financial concerns in the NHIS, the researchers wrote in their discussion. More research with longer follow-up time beyond 1-5 years is needed, wrote Dr. Zheng and colleagues.
Studies also are needed to illustrate how patient navigation can help prevent patients from falling through the cracks with regard to social needs and financial hardships, Mr. Biru told this news organization.
Other areas for research include how addressing social needs affects health outcomes and whether programs designed to address social needs are effective, he said.
“Finally, qualitative research is needed to capture the lived experiences of cancer survivors facing these challenges. This knowledge can inform the development of more patient-centered interventions and policies that effectively address the social determinants of health and improve overall outcomes for all cancer survivors,” Mr. Biru said.
What Is the Takeaway Message for Clinicians?
HRSNs and financial hardship are significantly associated with increased risk of mortality in adult cancer survivors, Dr. Zheng and colleagues concluded. Looking ahead, comprehensive assessment of HRSNs and financial hardship may help clinicians connect patients with relevant services to mitigate the social and financial impacts of cancer, they wrote.
“The takeaway message for oncologists in practice is that addressing [HRSNs] and financial hardship is crucial for providing comprehensive and equitable cancer care,” Mr. Biru said during his interview.
“The impact of social determinants of health on cancer outcomes cannot be ignored, and oncologists play a vital role in identifying and addressing these needs,” he said. Sensitive, discussion-based screenings are needed to identify core needs such as food and transportation, but clinicians also can consider broader social factors and work with a team to connect patients to appropriate resources, he added.
“By recognizing the importance of HRSN screening and taking proactive steps to address these needs, oncologists can contribute to improving health outcomes, reducing healthcare disparities, and providing more equitable cancer care for their patients,” he said.
What Other Guidance Is Available?
“High-quality cancer care requires treating the whole person; measuring and addressing anything in their life that could result in poorer health outcomes is a key component of comprehensive care,” Mr. Biru emphasized.
In September 2023, the National Comprehensive Cancer Network (NCCN) convened a working group cochaired by Mr. Biru that developed recommendations for how oncology practices should routinely measure HRSNs (NCCN.org/social-needs).
“The working group proposed that every cancer patient be assessed for food, transportation access, and financial and housing security at least once a year, and be reassessed at every care transition point as well,” Mr. Biru said. Such screenings should include follow-up to connect patients with services to address any HRSNs they are experiencing, he added.
Lead author Dr. Zheng is employed by the American Cancer Society, which as a nonprofit receives funds from the public through fundraising and contributions, as well as some support from corporations and industry to support its mission programs and services. Mr. Biru had no financial conflicts to disclose.
FROM CANCER
ADHD Tied to Risk for Lewy Body Disease, Dementia, MCI
, results of a new study showed.
“Determining whether there is an association between ADHD and subsequent conversion to a specific type of dementia is important. This information could generate opportunities for prevention and early treatment, as well as initiate research into the pathophysiological processes involved in understanding the process of cognitive decline,” the researchers, led by Ángel Golimstok, MD, of Hospital Italiano, Buenos Aires, Argentina, wrote.
The findings were published online in The American Journal of Geriatric Psychiatry.
Seeking Confirmation
The researchers first identified a link between DLB and ADHD in 2011. Since then, there have been eight additional studies from other groups also showing a possible link between ADHD and DLB.
To confirm the relationship, the researchers recruited 270 individuals between the ages of 45 and 70 years between 2007 and 2012. Of these, 161 had ADHD, and 109 were healthy controls.
Participants with ADHD met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text revision criteria for a diagnosis in the past and had a chronic course of ADHD symptoms from adolescence to adulthood that caused mild to severe impairment.
Investigators excluded participants who had been taking ADHD medications for 6 months or more, those with MCI at study initiation, and those with other comorbid psychiatric disorders.
At baseline, all participants received a physical exam, an MRI, and a neuropsychological exam to test for any type of dementia-related impairment.
Study participants were followed for an average of 12 years. A total of 27 individuals with ADHD developed dementia versus four patients in the control group (17% vs 4%, respectively), and 19 of those also had DLB (P = .002 for both).
Of those who developed any type of dementia, 87% were from the ADHD group. The most frequent type of dementia was DLB, 95% of which occurred in the ADHD group. Overall, DLB represented 70% of the dementia cases among participants with ADHD.
A total of 108 participants with ADHD were subsequently diagnosed with naMCI versus 19 healthy controls (67% vs 17%; P < .001).
“Although this pattern of deficits is reasonably expected in early DLB, these results should be interpreted with caution because they may be related to the overlap of symptoms and cognitive deficits between ADHD and naMCI, which may lead to an overestimation of the degenerative phenomenon. Thus, our cases of naMCI could correspond to the natural aging of ADHD patients and not to pathological deterioration,” the authors wrote.
The researchers pointed out that the sample of patients with ADHD originally sought evaluation because of a cognitive complaint or their own motivation. Therefore, the study results are not generalizable to all patients with ADHD. Another limitation was the relatively small number of patients included in the sample.
There was no reported source of funding, and there were no relevant disclosures reported.
A version of this article appeared on Medscape.com.
, results of a new study showed.
“Determining whether there is an association between ADHD and subsequent conversion to a specific type of dementia is important. This information could generate opportunities for prevention and early treatment, as well as initiate research into the pathophysiological processes involved in understanding the process of cognitive decline,” the researchers, led by Ángel Golimstok, MD, of Hospital Italiano, Buenos Aires, Argentina, wrote.
The findings were published online in The American Journal of Geriatric Psychiatry.
Seeking Confirmation
The researchers first identified a link between DLB and ADHD in 2011. Since then, there have been eight additional studies from other groups also showing a possible link between ADHD and DLB.
To confirm the relationship, the researchers recruited 270 individuals between the ages of 45 and 70 years between 2007 and 2012. Of these, 161 had ADHD, and 109 were healthy controls.
Participants with ADHD met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text revision criteria for a diagnosis in the past and had a chronic course of ADHD symptoms from adolescence to adulthood that caused mild to severe impairment.
Investigators excluded participants who had been taking ADHD medications for 6 months or more, those with MCI at study initiation, and those with other comorbid psychiatric disorders.
At baseline, all participants received a physical exam, an MRI, and a neuropsychological exam to test for any type of dementia-related impairment.
Study participants were followed for an average of 12 years. A total of 27 individuals with ADHD developed dementia versus four patients in the control group (17% vs 4%, respectively), and 19 of those also had DLB (P = .002 for both).
Of those who developed any type of dementia, 87% were from the ADHD group. The most frequent type of dementia was DLB, 95% of which occurred in the ADHD group. Overall, DLB represented 70% of the dementia cases among participants with ADHD.
A total of 108 participants with ADHD were subsequently diagnosed with naMCI versus 19 healthy controls (67% vs 17%; P < .001).
“Although this pattern of deficits is reasonably expected in early DLB, these results should be interpreted with caution because they may be related to the overlap of symptoms and cognitive deficits between ADHD and naMCI, which may lead to an overestimation of the degenerative phenomenon. Thus, our cases of naMCI could correspond to the natural aging of ADHD patients and not to pathological deterioration,” the authors wrote.
The researchers pointed out that the sample of patients with ADHD originally sought evaluation because of a cognitive complaint or their own motivation. Therefore, the study results are not generalizable to all patients with ADHD. Another limitation was the relatively small number of patients included in the sample.
There was no reported source of funding, and there were no relevant disclosures reported.
A version of this article appeared on Medscape.com.
, results of a new study showed.
“Determining whether there is an association between ADHD and subsequent conversion to a specific type of dementia is important. This information could generate opportunities for prevention and early treatment, as well as initiate research into the pathophysiological processes involved in understanding the process of cognitive decline,” the researchers, led by Ángel Golimstok, MD, of Hospital Italiano, Buenos Aires, Argentina, wrote.
The findings were published online in The American Journal of Geriatric Psychiatry.
Seeking Confirmation
The researchers first identified a link between DLB and ADHD in 2011. Since then, there have been eight additional studies from other groups also showing a possible link between ADHD and DLB.
To confirm the relationship, the researchers recruited 270 individuals between the ages of 45 and 70 years between 2007 and 2012. Of these, 161 had ADHD, and 109 were healthy controls.
Participants with ADHD met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text revision criteria for a diagnosis in the past and had a chronic course of ADHD symptoms from adolescence to adulthood that caused mild to severe impairment.
Investigators excluded participants who had been taking ADHD medications for 6 months or more, those with MCI at study initiation, and those with other comorbid psychiatric disorders.
At baseline, all participants received a physical exam, an MRI, and a neuropsychological exam to test for any type of dementia-related impairment.
Study participants were followed for an average of 12 years. A total of 27 individuals with ADHD developed dementia versus four patients in the control group (17% vs 4%, respectively), and 19 of those also had DLB (P = .002 for both).
Of those who developed any type of dementia, 87% were from the ADHD group. The most frequent type of dementia was DLB, 95% of which occurred in the ADHD group. Overall, DLB represented 70% of the dementia cases among participants with ADHD.
A total of 108 participants with ADHD were subsequently diagnosed with naMCI versus 19 healthy controls (67% vs 17%; P < .001).
“Although this pattern of deficits is reasonably expected in early DLB, these results should be interpreted with caution because they may be related to the overlap of symptoms and cognitive deficits between ADHD and naMCI, which may lead to an overestimation of the degenerative phenomenon. Thus, our cases of naMCI could correspond to the natural aging of ADHD patients and not to pathological deterioration,” the authors wrote.
The researchers pointed out that the sample of patients with ADHD originally sought evaluation because of a cognitive complaint or their own motivation. Therefore, the study results are not generalizable to all patients with ADHD. Another limitation was the relatively small number of patients included in the sample.
There was no reported source of funding, and there were no relevant disclosures reported.
A version of this article appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
Proton Pump Inhibitors Tied to Migraine, Other Severe Headache Types
, new research showed.
Using data from the National Health and Nutrition Examination Survey (NHANES), investigators conducted a cross-sectional analysis and found all types of acid-suppression therapy were associated with an increased risk for severe headache including migraine but that PPIs conferred the greatest risk.
“It’s important to note that many people do need acid-reducing medications to manage acid reflux or other conditions, and people with migraine or severe headache who are taking these drugs or supplements should talk with their doctors about whether they should continue,” lead author Margaret Slavin, PhD, of the University of Maryland in College Park, said in a press release.
The findings were published online in Neurology Clinical Practice.
New Look at Old Data
Previous research has shown that headache is listed among the most common adverse reactions in adults taking PPIs and histamine receptor agonists (H2RAs), which include cimetidine, famotidine, and nizatidine.
Other large studies of health databases have shown increased headache risk within a week of PPI exposure.
To compare the risk from PPIs versus H2RAs and other generics, researchers analyzed data from the NHANES for those who used PPIs, H2RAs, and generic antacids to learn more about the potential link between acid-suppression therapy and headache.
They used survey data from 1999 to 2004, the only years the NHANES included a question about migraine and other headache during the past 3 months.
Investigators analyzed data for 11,800 participants aged 20 years or older who used prescription drugs, over-the-counter medications, and nutritional supplements during the past month.
Participants who used acid-suppressing medications had an increased risk for migraine or severe headache versus those who did not use these agents. Investigators found PPIs were tied to a 70% increased risk, while H2RAs and antacids were associated with 40% and 30% higher risks, respectively. Use of any type of acid-suppression therapy was tied to a 47% increased risk for severe headache.
Magnesium a Risk Factor?
While magnesium supplements are sometimes prescribed as a “natural” headache prevention therapy to prevent migraine and other headache types, the investigators noted they were surprised to find individuals taking H2RAs who met the dietary reference intake for magnesium had a nearly threefold increased risk for migraine or severe headache (odds ratio, 2.80; 95% CI, 1.02-1.45; P = .025).
However, there was no association between magnesium and the other acid-reducing medications.
The study’s limitations included the use of a single question to identify migraine or severe headache, which may have resulted in some misclassification of the outcome. The authors also pointed out that dietary and drug-intake data may be subject to recall bias.
“These results suggest that there is a need for more intentionally designed prospective work to inform the extent to which associations between migraine and acid-suppression therapy are merely detecting comorbidities or to what extent migraine is an adverse event associated with the medications,” the authors wrote.
There was no targeted funding. Disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
, new research showed.
Using data from the National Health and Nutrition Examination Survey (NHANES), investigators conducted a cross-sectional analysis and found all types of acid-suppression therapy were associated with an increased risk for severe headache including migraine but that PPIs conferred the greatest risk.
“It’s important to note that many people do need acid-reducing medications to manage acid reflux or other conditions, and people with migraine or severe headache who are taking these drugs or supplements should talk with their doctors about whether they should continue,” lead author Margaret Slavin, PhD, of the University of Maryland in College Park, said in a press release.
The findings were published online in Neurology Clinical Practice.
New Look at Old Data
Previous research has shown that headache is listed among the most common adverse reactions in adults taking PPIs and histamine receptor agonists (H2RAs), which include cimetidine, famotidine, and nizatidine.
Other large studies of health databases have shown increased headache risk within a week of PPI exposure.
To compare the risk from PPIs versus H2RAs and other generics, researchers analyzed data from the NHANES for those who used PPIs, H2RAs, and generic antacids to learn more about the potential link between acid-suppression therapy and headache.
They used survey data from 1999 to 2004, the only years the NHANES included a question about migraine and other headache during the past 3 months.
Investigators analyzed data for 11,800 participants aged 20 years or older who used prescription drugs, over-the-counter medications, and nutritional supplements during the past month.
Participants who used acid-suppressing medications had an increased risk for migraine or severe headache versus those who did not use these agents. Investigators found PPIs were tied to a 70% increased risk, while H2RAs and antacids were associated with 40% and 30% higher risks, respectively. Use of any type of acid-suppression therapy was tied to a 47% increased risk for severe headache.
Magnesium a Risk Factor?
While magnesium supplements are sometimes prescribed as a “natural” headache prevention therapy to prevent migraine and other headache types, the investigators noted they were surprised to find individuals taking H2RAs who met the dietary reference intake for magnesium had a nearly threefold increased risk for migraine or severe headache (odds ratio, 2.80; 95% CI, 1.02-1.45; P = .025).
However, there was no association between magnesium and the other acid-reducing medications.
The study’s limitations included the use of a single question to identify migraine or severe headache, which may have resulted in some misclassification of the outcome. The authors also pointed out that dietary and drug-intake data may be subject to recall bias.
“These results suggest that there is a need for more intentionally designed prospective work to inform the extent to which associations between migraine and acid-suppression therapy are merely detecting comorbidities or to what extent migraine is an adverse event associated with the medications,” the authors wrote.
There was no targeted funding. Disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
, new research showed.
Using data from the National Health and Nutrition Examination Survey (NHANES), investigators conducted a cross-sectional analysis and found all types of acid-suppression therapy were associated with an increased risk for severe headache including migraine but that PPIs conferred the greatest risk.
“It’s important to note that many people do need acid-reducing medications to manage acid reflux or other conditions, and people with migraine or severe headache who are taking these drugs or supplements should talk with their doctors about whether they should continue,” lead author Margaret Slavin, PhD, of the University of Maryland in College Park, said in a press release.
The findings were published online in Neurology Clinical Practice.
New Look at Old Data
Previous research has shown that headache is listed among the most common adverse reactions in adults taking PPIs and histamine receptor agonists (H2RAs), which include cimetidine, famotidine, and nizatidine.
Other large studies of health databases have shown increased headache risk within a week of PPI exposure.
To compare the risk from PPIs versus H2RAs and other generics, researchers analyzed data from the NHANES for those who used PPIs, H2RAs, and generic antacids to learn more about the potential link between acid-suppression therapy and headache.
They used survey data from 1999 to 2004, the only years the NHANES included a question about migraine and other headache during the past 3 months.
Investigators analyzed data for 11,800 participants aged 20 years or older who used prescription drugs, over-the-counter medications, and nutritional supplements during the past month.
Participants who used acid-suppressing medications had an increased risk for migraine or severe headache versus those who did not use these agents. Investigators found PPIs were tied to a 70% increased risk, while H2RAs and antacids were associated with 40% and 30% higher risks, respectively. Use of any type of acid-suppression therapy was tied to a 47% increased risk for severe headache.
Magnesium a Risk Factor?
While magnesium supplements are sometimes prescribed as a “natural” headache prevention therapy to prevent migraine and other headache types, the investigators noted they were surprised to find individuals taking H2RAs who met the dietary reference intake for magnesium had a nearly threefold increased risk for migraine or severe headache (odds ratio, 2.80; 95% CI, 1.02-1.45; P = .025).
However, there was no association between magnesium and the other acid-reducing medications.
The study’s limitations included the use of a single question to identify migraine or severe headache, which may have resulted in some misclassification of the outcome. The authors also pointed out that dietary and drug-intake data may be subject to recall bias.
“These results suggest that there is a need for more intentionally designed prospective work to inform the extent to which associations between migraine and acid-suppression therapy are merely detecting comorbidities or to what extent migraine is an adverse event associated with the medications,” the authors wrote.
There was no targeted funding. Disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
FROM NEUROLOGY CLINICAL PRACTICE
New HIV Infections After Vampire Facials at Unlicensed Spa
At least three clients of an unlicensed spa in New Mexico contracted HIV after receiving platelet-rich plasma (PRP) microneedling facials, according to an investigation by the US Centers for Disease Control and Prevention (CDC).
The investigation, spanning 5 years with parts of it still ongoing, has resulted in the closure of the spa and is raising questions about public safety in cosmetic clinics.
Though transmission of HIV by unsterile injection practices is a known risk, this is the first time it has been linked to cosmetic injection services, said Anna Stadelman-Behar, PhD, MPH, of the CDC’s Epidemic Intelligence Service.
Sometimes called a vampire facial, the PRP treatment involves taking a patient’s own blood and separating it in a centrifuge. The portion containing a high concentration of platelets is then reinjected with a syringe or microneedling device.
“The idea is that when you inject this concentrated amount of platelets, the growth factors that the platelets release help to stimulate the regenerative nature of that area,” said Anthony Rossi, MD, professor of dermatology at Weill Cornell Medical College in New York, and attending dermatologist at Memorial Sloan Kettering Cancer Center.
The infections under investigation first came to light when a woman was diagnosed with HIV with no known risk factors for the disease other than exposure to microneedling facials at a cosmetic spa.
The New Mexico Department of Health and the CDC launched an investigation of the spa and discovered a litany of “gross violations of infection control practices,” said Dr. Stadelman-Behar.
Infection-Control Violations
At the spa in New Mexico, investigators found:
- On a kitchen counter, a centrifuge, a heating dry bath, and a rack of unlabeled tubes containing blood
- In a refrigerator, unlabeled tubes of blood and medical injectables including botox and lidocaine stored along with food
- Unwrapped syringes in drawers, on counters, and discarded in regular trash cans
- No autoclave for steam sterilization on the premises
- Only surface cleaning for procedure equipment with ammonium chloride disinfecting spray and benzalkonium chloride disinfecting wipes after each client visit
- Disposable electric desiccator tips cleaned only by alcohol immersion to be reused
The spa’s owner operated without appropriate licenses at multiple locations and did not have an appointment scheduling system that stored client contact information.
Investigators contacted as many people as they could find and launched a large-scale community outreach effort to find more.
In total, four clients and one intimate partner of a client were diagnosed with HIV during the investigation, but one client and her partner were determined to likely have been infected before the spa visit.
It is not clear whether the infections were due to unlabeled contaminated blood products being given to the wrong client or contamination on shared needles. Investigators did not have the authority to collect specimens during their site visit that would have allowed them to study that.
“We can’t definitively say what the route of contamination was,” noted Dr. Stadelman-Behar.
Anne Chapas, MD, a board-certified dermatologist, and instructor at Mount Sinai Hospital in New York, added that just because a procedure is cosmetic, that doesn’t mean it is not medical. “Personally, I feel it should only be done by medical practitioners who understand the risks.”
A Medical Procedure
PRP microneedling has been used extensively in orthopedic surgery to promote joint regeneration. For the past 10 years, it has also been used in dermatology to treat hair loss from alopecia, to augment wound healing, and cosmetically to reduce facial wrinkles.
It is generally done in a doctor’s office or medical spa, and the procedure takes about half an hour.
Dr. Stadelman-Behar said that this ongoing investigation highlights the importance of front-line healthcare workers using their clinical expertise to help identify potential new routes of transmission for infections. “It was provider-led intuition that sparked this investigation, so it’s important to let the department of health know if there is something amiss with any of the exposures that the patient might have had,” she said.
A version of this article appeared on Medscape.com.
At least three clients of an unlicensed spa in New Mexico contracted HIV after receiving platelet-rich plasma (PRP) microneedling facials, according to an investigation by the US Centers for Disease Control and Prevention (CDC).
The investigation, spanning 5 years with parts of it still ongoing, has resulted in the closure of the spa and is raising questions about public safety in cosmetic clinics.
Though transmission of HIV by unsterile injection practices is a known risk, this is the first time it has been linked to cosmetic injection services, said Anna Stadelman-Behar, PhD, MPH, of the CDC’s Epidemic Intelligence Service.
Sometimes called a vampire facial, the PRP treatment involves taking a patient’s own blood and separating it in a centrifuge. The portion containing a high concentration of platelets is then reinjected with a syringe or microneedling device.
“The idea is that when you inject this concentrated amount of platelets, the growth factors that the platelets release help to stimulate the regenerative nature of that area,” said Anthony Rossi, MD, professor of dermatology at Weill Cornell Medical College in New York, and attending dermatologist at Memorial Sloan Kettering Cancer Center.
The infections under investigation first came to light when a woman was diagnosed with HIV with no known risk factors for the disease other than exposure to microneedling facials at a cosmetic spa.
The New Mexico Department of Health and the CDC launched an investigation of the spa and discovered a litany of “gross violations of infection control practices,” said Dr. Stadelman-Behar.
Infection-Control Violations
At the spa in New Mexico, investigators found:
- On a kitchen counter, a centrifuge, a heating dry bath, and a rack of unlabeled tubes containing blood
- In a refrigerator, unlabeled tubes of blood and medical injectables including botox and lidocaine stored along with food
- Unwrapped syringes in drawers, on counters, and discarded in regular trash cans
- No autoclave for steam sterilization on the premises
- Only surface cleaning for procedure equipment with ammonium chloride disinfecting spray and benzalkonium chloride disinfecting wipes after each client visit
- Disposable electric desiccator tips cleaned only by alcohol immersion to be reused
The spa’s owner operated without appropriate licenses at multiple locations and did not have an appointment scheduling system that stored client contact information.
Investigators contacted as many people as they could find and launched a large-scale community outreach effort to find more.
In total, four clients and one intimate partner of a client were diagnosed with HIV during the investigation, but one client and her partner were determined to likely have been infected before the spa visit.
It is not clear whether the infections were due to unlabeled contaminated blood products being given to the wrong client or contamination on shared needles. Investigators did not have the authority to collect specimens during their site visit that would have allowed them to study that.
“We can’t definitively say what the route of contamination was,” noted Dr. Stadelman-Behar.
Anne Chapas, MD, a board-certified dermatologist, and instructor at Mount Sinai Hospital in New York, added that just because a procedure is cosmetic, that doesn’t mean it is not medical. “Personally, I feel it should only be done by medical practitioners who understand the risks.”
A Medical Procedure
PRP microneedling has been used extensively in orthopedic surgery to promote joint regeneration. For the past 10 years, it has also been used in dermatology to treat hair loss from alopecia, to augment wound healing, and cosmetically to reduce facial wrinkles.
It is generally done in a doctor’s office or medical spa, and the procedure takes about half an hour.
Dr. Stadelman-Behar said that this ongoing investigation highlights the importance of front-line healthcare workers using their clinical expertise to help identify potential new routes of transmission for infections. “It was provider-led intuition that sparked this investigation, so it’s important to let the department of health know if there is something amiss with any of the exposures that the patient might have had,” she said.
A version of this article appeared on Medscape.com.
At least three clients of an unlicensed spa in New Mexico contracted HIV after receiving platelet-rich plasma (PRP) microneedling facials, according to an investigation by the US Centers for Disease Control and Prevention (CDC).
The investigation, spanning 5 years with parts of it still ongoing, has resulted in the closure of the spa and is raising questions about public safety in cosmetic clinics.
Though transmission of HIV by unsterile injection practices is a known risk, this is the first time it has been linked to cosmetic injection services, said Anna Stadelman-Behar, PhD, MPH, of the CDC’s Epidemic Intelligence Service.
Sometimes called a vampire facial, the PRP treatment involves taking a patient’s own blood and separating it in a centrifuge. The portion containing a high concentration of platelets is then reinjected with a syringe or microneedling device.
“The idea is that when you inject this concentrated amount of platelets, the growth factors that the platelets release help to stimulate the regenerative nature of that area,” said Anthony Rossi, MD, professor of dermatology at Weill Cornell Medical College in New York, and attending dermatologist at Memorial Sloan Kettering Cancer Center.
The infections under investigation first came to light when a woman was diagnosed with HIV with no known risk factors for the disease other than exposure to microneedling facials at a cosmetic spa.
The New Mexico Department of Health and the CDC launched an investigation of the spa and discovered a litany of “gross violations of infection control practices,” said Dr. Stadelman-Behar.
Infection-Control Violations
At the spa in New Mexico, investigators found:
- On a kitchen counter, a centrifuge, a heating dry bath, and a rack of unlabeled tubes containing blood
- In a refrigerator, unlabeled tubes of blood and medical injectables including botox and lidocaine stored along with food
- Unwrapped syringes in drawers, on counters, and discarded in regular trash cans
- No autoclave for steam sterilization on the premises
- Only surface cleaning for procedure equipment with ammonium chloride disinfecting spray and benzalkonium chloride disinfecting wipes after each client visit
- Disposable electric desiccator tips cleaned only by alcohol immersion to be reused
The spa’s owner operated without appropriate licenses at multiple locations and did not have an appointment scheduling system that stored client contact information.
Investigators contacted as many people as they could find and launched a large-scale community outreach effort to find more.
In total, four clients and one intimate partner of a client were diagnosed with HIV during the investigation, but one client and her partner were determined to likely have been infected before the spa visit.
It is not clear whether the infections were due to unlabeled contaminated blood products being given to the wrong client or contamination on shared needles. Investigators did not have the authority to collect specimens during their site visit that would have allowed them to study that.
“We can’t definitively say what the route of contamination was,” noted Dr. Stadelman-Behar.
Anne Chapas, MD, a board-certified dermatologist, and instructor at Mount Sinai Hospital in New York, added that just because a procedure is cosmetic, that doesn’t mean it is not medical. “Personally, I feel it should only be done by medical practitioners who understand the risks.”
A Medical Procedure
PRP microneedling has been used extensively in orthopedic surgery to promote joint regeneration. For the past 10 years, it has also been used in dermatology to treat hair loss from alopecia, to augment wound healing, and cosmetically to reduce facial wrinkles.
It is generally done in a doctor’s office or medical spa, and the procedure takes about half an hour.
Dr. Stadelman-Behar said that this ongoing investigation highlights the importance of front-line healthcare workers using their clinical expertise to help identify potential new routes of transmission for infections. “It was provider-led intuition that sparked this investigation, so it’s important to let the department of health know if there is something amiss with any of the exposures that the patient might have had,” she said.
A version of this article appeared on Medscape.com.
Terminal Cancer: What Matters to Patients and Caregivers
New research found that patients and caregivers both tend to prioritize symptom control over life extension but often preferring a balance. Patients and caregivers, however, are less aligned on decisions about cost containment, with patients more likely to prioritize cost containment.
“Our research has revealed that patients and caregivers generally share similar end-of-life goals,” with a “notable exception” when it comes to costs, first author Semra Ozdemir, PhD, with the Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore, told this news organization.
However, when patients and caregivers have a better understanding of the patient’s prognosis, both may be more inclined to avoid costly life-extending treatments and prioritize symptom management.
In other words, the survey suggests that “knowing the prognosis helps patients and their families set realistic expectations for care and adequately prepare for end-of-life decisions,” said Dr. Ozdemir.
This study was published online in JAMA Network Open.
Patients with advanced cancer often face difficult decisions: Do they opt for treatments that may — or may not — extend life or do they focus more on symptom control?
Family caregivers, who also play an important role in this decision-making process, may have different care goals. Some research suggests that caregivers tend to prioritize treatments that could extend life, whereas patients prioritize symptom management, but it’s less clear how these priorities may change over time and how patients and caregivers may influence each other.
In the current study, the researchers examined goals of care among patients with stage IV solid tumors and caregivers during the last 2 years of life, focusing on life extension vs symptom management and cost containment, as well as how these goals changed over time.
The survey included 210 patient-caregiver pairs, recruited from outpatient clinics at two major cancer centers in Singapore. Patients had a mean age of 63 years, and about half were men. The caregivers had a mean age of 49 years, and almost two third (63%) were women.
Overall, 34% patients and 29% caregivers prioritized symptom management over life extension, whereas 24% patients and 19% caregivers prioritized life extension. Most patients and caregivers preferred balancing the two, with 34%-47% patients and 37%-69% caregivers supporting this approach.
When balancing cost and treatment decisions, however, patients were more likely to prioritize containing costs — 28% vs 17% for caregivers — over extending life — 26% of patients vs 35% of caregivers.
Cost containment tended to be more of a priority for older patients, those with a higher symptom burden, and those with less family caregiver support. For caregivers, cost containment was more of a priority for those who reported that caregiving had a big impact on their finances, those with worse self-esteem related to their caregiving abilities, as well as those caring for older patients.
To better align cost containment priorities between patients and caregivers, it’s essential for families to engage in open and thorough discussions about the allocation of resources, Dr. Ozdemir said.
Although “patients, families, and physicians often avoid discussions about prognosis,” such conversations are essential for setting realistic expectations for care and adequately preparing for end-of-life decisions, Dr. Ozdemir told this news organization.
“These conversations should aim to balance competing interests and create care plans that are mutually acceptable to both patients and caregivers,” she said, adding that “this approach will help in minimizing any potential conflicts and ensure that both parties feel respected and understood in their decision-making process.”
Managing Unrealistic Expectations
As patients approached the end of life, neither patients nor caregivers shifted their priorities from life extension to symptom management.
This finding raises concerns because it suggests that many patients hold unrealistic expectations regarding their care and “underscores the need for continuous dialogue and reassessment of care goals throughout the progression of illness,” Dr. Ozdemir said.
“This stability in preferences over time suggests that initial care decisions are deeply ingrained or that there may be a lack of ongoing communication about evolving care needs and possibilities as conditions change,” Ozdemir said.
Yet, it can be hard to define what unrealistic expectations mean, said Olivia Seecof, MD, who wasn’t involved in the study.
“I think people are hopeful that a devastating diagnosis won’t lead to the end of their life and that there will be a treatment or something that will change [their prognosis], and they’ll get better,” said Dr. Seecof, palliative care expert with the Supportive Oncology Program at NYU Langone Health’s Perlmutter Cancer Center in New York City.
Giving patients and caregivers a realistic understanding of the prognosis is important, but “there’s more to it than just telling the patient their diagnosis,” she said.
“We have to plan for end of life, what it can look like,” said Dr. Seecof, adding that “often we don’t do a very good job of talking about that early on in an illness course.”
Overall, though, Dr. Seecof stressed that no two patients or situations are the same, and it’s important to understand what’s important in each scenario. End-of-life care requires “an individual approach because every patient is different, even if they have the same diagnosis as someone else,” she said.
This work was supported by funding from the Singapore Millennium Foundation and the Lien Centre for Palliative Care. Dr. Ozdemir and Dr. Seecof had no relevant disclosures.
A version of this article appeared on Medscape.com.
New research found that patients and caregivers both tend to prioritize symptom control over life extension but often preferring a balance. Patients and caregivers, however, are less aligned on decisions about cost containment, with patients more likely to prioritize cost containment.
“Our research has revealed that patients and caregivers generally share similar end-of-life goals,” with a “notable exception” when it comes to costs, first author Semra Ozdemir, PhD, with the Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore, told this news organization.
However, when patients and caregivers have a better understanding of the patient’s prognosis, both may be more inclined to avoid costly life-extending treatments and prioritize symptom management.
In other words, the survey suggests that “knowing the prognosis helps patients and their families set realistic expectations for care and adequately prepare for end-of-life decisions,” said Dr. Ozdemir.
This study was published online in JAMA Network Open.
Patients with advanced cancer often face difficult decisions: Do they opt for treatments that may — or may not — extend life or do they focus more on symptom control?
Family caregivers, who also play an important role in this decision-making process, may have different care goals. Some research suggests that caregivers tend to prioritize treatments that could extend life, whereas patients prioritize symptom management, but it’s less clear how these priorities may change over time and how patients and caregivers may influence each other.
In the current study, the researchers examined goals of care among patients with stage IV solid tumors and caregivers during the last 2 years of life, focusing on life extension vs symptom management and cost containment, as well as how these goals changed over time.
The survey included 210 patient-caregiver pairs, recruited from outpatient clinics at two major cancer centers in Singapore. Patients had a mean age of 63 years, and about half were men. The caregivers had a mean age of 49 years, and almost two third (63%) were women.
Overall, 34% patients and 29% caregivers prioritized symptom management over life extension, whereas 24% patients and 19% caregivers prioritized life extension. Most patients and caregivers preferred balancing the two, with 34%-47% patients and 37%-69% caregivers supporting this approach.
When balancing cost and treatment decisions, however, patients were more likely to prioritize containing costs — 28% vs 17% for caregivers — over extending life — 26% of patients vs 35% of caregivers.
Cost containment tended to be more of a priority for older patients, those with a higher symptom burden, and those with less family caregiver support. For caregivers, cost containment was more of a priority for those who reported that caregiving had a big impact on their finances, those with worse self-esteem related to their caregiving abilities, as well as those caring for older patients.
To better align cost containment priorities between patients and caregivers, it’s essential for families to engage in open and thorough discussions about the allocation of resources, Dr. Ozdemir said.
Although “patients, families, and physicians often avoid discussions about prognosis,” such conversations are essential for setting realistic expectations for care and adequately preparing for end-of-life decisions, Dr. Ozdemir told this news organization.
“These conversations should aim to balance competing interests and create care plans that are mutually acceptable to both patients and caregivers,” she said, adding that “this approach will help in minimizing any potential conflicts and ensure that both parties feel respected and understood in their decision-making process.”
Managing Unrealistic Expectations
As patients approached the end of life, neither patients nor caregivers shifted their priorities from life extension to symptom management.
This finding raises concerns because it suggests that many patients hold unrealistic expectations regarding their care and “underscores the need for continuous dialogue and reassessment of care goals throughout the progression of illness,” Dr. Ozdemir said.
“This stability in preferences over time suggests that initial care decisions are deeply ingrained or that there may be a lack of ongoing communication about evolving care needs and possibilities as conditions change,” Ozdemir said.
Yet, it can be hard to define what unrealistic expectations mean, said Olivia Seecof, MD, who wasn’t involved in the study.
“I think people are hopeful that a devastating diagnosis won’t lead to the end of their life and that there will be a treatment or something that will change [their prognosis], and they’ll get better,” said Dr. Seecof, palliative care expert with the Supportive Oncology Program at NYU Langone Health’s Perlmutter Cancer Center in New York City.
Giving patients and caregivers a realistic understanding of the prognosis is important, but “there’s more to it than just telling the patient their diagnosis,” she said.
“We have to plan for end of life, what it can look like,” said Dr. Seecof, adding that “often we don’t do a very good job of talking about that early on in an illness course.”
Overall, though, Dr. Seecof stressed that no two patients or situations are the same, and it’s important to understand what’s important in each scenario. End-of-life care requires “an individual approach because every patient is different, even if they have the same diagnosis as someone else,” she said.
This work was supported by funding from the Singapore Millennium Foundation and the Lien Centre for Palliative Care. Dr. Ozdemir and Dr. Seecof had no relevant disclosures.
A version of this article appeared on Medscape.com.
New research found that patients and caregivers both tend to prioritize symptom control over life extension but often preferring a balance. Patients and caregivers, however, are less aligned on decisions about cost containment, with patients more likely to prioritize cost containment.
“Our research has revealed that patients and caregivers generally share similar end-of-life goals,” with a “notable exception” when it comes to costs, first author Semra Ozdemir, PhD, with the Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore, told this news organization.
However, when patients and caregivers have a better understanding of the patient’s prognosis, both may be more inclined to avoid costly life-extending treatments and prioritize symptom management.
In other words, the survey suggests that “knowing the prognosis helps patients and their families set realistic expectations for care and adequately prepare for end-of-life decisions,” said Dr. Ozdemir.
This study was published online in JAMA Network Open.
Patients with advanced cancer often face difficult decisions: Do they opt for treatments that may — or may not — extend life or do they focus more on symptom control?
Family caregivers, who also play an important role in this decision-making process, may have different care goals. Some research suggests that caregivers tend to prioritize treatments that could extend life, whereas patients prioritize symptom management, but it’s less clear how these priorities may change over time and how patients and caregivers may influence each other.
In the current study, the researchers examined goals of care among patients with stage IV solid tumors and caregivers during the last 2 years of life, focusing on life extension vs symptom management and cost containment, as well as how these goals changed over time.
The survey included 210 patient-caregiver pairs, recruited from outpatient clinics at two major cancer centers in Singapore. Patients had a mean age of 63 years, and about half were men. The caregivers had a mean age of 49 years, and almost two third (63%) were women.
Overall, 34% patients and 29% caregivers prioritized symptom management over life extension, whereas 24% patients and 19% caregivers prioritized life extension. Most patients and caregivers preferred balancing the two, with 34%-47% patients and 37%-69% caregivers supporting this approach.
When balancing cost and treatment decisions, however, patients were more likely to prioritize containing costs — 28% vs 17% for caregivers — over extending life — 26% of patients vs 35% of caregivers.
Cost containment tended to be more of a priority for older patients, those with a higher symptom burden, and those with less family caregiver support. For caregivers, cost containment was more of a priority for those who reported that caregiving had a big impact on their finances, those with worse self-esteem related to their caregiving abilities, as well as those caring for older patients.
To better align cost containment priorities between patients and caregivers, it’s essential for families to engage in open and thorough discussions about the allocation of resources, Dr. Ozdemir said.
Although “patients, families, and physicians often avoid discussions about prognosis,” such conversations are essential for setting realistic expectations for care and adequately preparing for end-of-life decisions, Dr. Ozdemir told this news organization.
“These conversations should aim to balance competing interests and create care plans that are mutually acceptable to both patients and caregivers,” she said, adding that “this approach will help in minimizing any potential conflicts and ensure that both parties feel respected and understood in their decision-making process.”
Managing Unrealistic Expectations
As patients approached the end of life, neither patients nor caregivers shifted their priorities from life extension to symptom management.
This finding raises concerns because it suggests that many patients hold unrealistic expectations regarding their care and “underscores the need for continuous dialogue and reassessment of care goals throughout the progression of illness,” Dr. Ozdemir said.
“This stability in preferences over time suggests that initial care decisions are deeply ingrained or that there may be a lack of ongoing communication about evolving care needs and possibilities as conditions change,” Ozdemir said.
Yet, it can be hard to define what unrealistic expectations mean, said Olivia Seecof, MD, who wasn’t involved in the study.
“I think people are hopeful that a devastating diagnosis won’t lead to the end of their life and that there will be a treatment or something that will change [their prognosis], and they’ll get better,” said Dr. Seecof, palliative care expert with the Supportive Oncology Program at NYU Langone Health’s Perlmutter Cancer Center in New York City.
Giving patients and caregivers a realistic understanding of the prognosis is important, but “there’s more to it than just telling the patient their diagnosis,” she said.
“We have to plan for end of life, what it can look like,” said Dr. Seecof, adding that “often we don’t do a very good job of talking about that early on in an illness course.”
Overall, though, Dr. Seecof stressed that no two patients or situations are the same, and it’s important to understand what’s important in each scenario. End-of-life care requires “an individual approach because every patient is different, even if they have the same diagnosis as someone else,” she said.
This work was supported by funding from the Singapore Millennium Foundation and the Lien Centre for Palliative Care. Dr. Ozdemir and Dr. Seecof had no relevant disclosures.
A version of this article appeared on Medscape.com.
Home ventilation consult
Specialist input on a sudden shift in device availability
Philips Respironics released a public statement on January 25, 2024, that would dramatically change the landscape of home mechanical ventilation and sleep-disordered breathing management in the United States. The company announced that, effective immediately in the US and US territories, Philips Respironics would stop production and sale of all hospital and home mechanical ventilation products, home and hospital ventilation devices, and oxygen concentrators.
Why is this happening?
John M. Coleman III, MD, FCCP: To understand the current Philips Respironics announcement, we must go back to June 2021. At that time, Philips recalled certain home mechanical ventilators, CPAP machines, and BiPAP machines due to potential health risks related to breakdown of the polyester-based polyurethane (PE-PUR) foam placed in these devices for noise reduction. Small and microscopic particles of this foam were at risk for being inhaled or ingested by patients using these devices. It was suspected that inhalation of these particles could potentially result in temporary or permanent injury. Machines in hot temperatures or using ozone cleaning were at increased risk. The US Food and Drug Administration (FDA) issued a class 1 recall, defined as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
In the months following the initial recall, there were additional recalls of both in-hospital and home ventilators related to the potential of these foam particles to move and block the air path, reducing airflow and causing the device to alarm.
Over the next few years, tens of thousands of medical device reports were filed about PE-PUR foam-related injuries, with some cases resulting in death. At this time, the Department of Justice began collaborating with the FDA on a consent decree. There were ongoing recalls of the CoughAssist T70 device, as well as the newest generation of Philips Respironics home ventilators, the Trilogy EVO.
Ultimately, after years of ongoing recalls and reports of numerous deaths and injuries, with multiple class action lawsuits, the consent decree was finalized. Philips Respironics agreed to stop production of all respiratory-related products in the US and US territories.
What devices does this apply to?
Jason Ackrivo, MD: This notice affects the devices shown in Table 1. All sales and device shipments have been discontinued as of January 25, 2024. Philips Respironics will continue to service the devices, subject to part availability, up to 5 years after sales discontinuation. However, Philips Respironics will continue to sell consumables and accessories, including masks.
What are my options for home mechanical ventilators?
Bethany L. Lussier, MD, FCCP: In the US, alternative approved home mechanical ventilator (HMV) devices include Astral by ResMed, Vivo 45 and Vivo 65 by Breas, and VOCSN by Ventec. Additional options made available through emergency use authorization by the FDA between 2020 and 2022 included Luisa by Löwenstein Medical, the V+ by Ventec, and Life2000 by Baxter. Many of us expedite disposition from the hospital by prescribing HMVs rather than respiratory assist devices (RADs) because it is easier to meet qualifying criteria for insurance. In efforts to promote just allocation of resources, now might be the ideal time to reconsider higher utilization of RADs over HMVs. Reasonable RAD candidates are those who do not need autotitration of EPAP, dual mode therapy, or invasive ventilation. In these cases, the qualifying criteria and patient needs may be met with a RAD capable of VAPS or BPAP-ST mode.
How are these alternative devices similar to and different from the Trilogy EVO?
Dr. Ackrivo:All these devices are portable ventilators that can deliver noninvasive or invasive ventilation. They have internal batteries for enabling portability. They offer multiple programmable presets and mouthpiece ventilation, and some offer both oxygenation and CO2 monitoring (both TcCO2 and EtCO2).
All alternative portable ventilators include a proprietary ventilation mode analogous to the Trilogy AVAPS algorithm (Table 2). The ResMed Astral has a safety tidal volume feature that targets a minimum tidal volume in PS, S/T, or P(A)C modes. The ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. The Breas Vivo can target a tidal volume (TgV) in either PSV or PCV mode.
Unique ventilator characteristics are shown in Table 2. ResMed Astral mode options will differ between leak (passive) or valve (active) circuits. Both the Breas Vivo and Löwenstein Luisa enable high-flow oxygen delivery. Only the Breas Vivo enables connecting to a transcutaneous carbon dioxide monitor. The VOCSN name is an acronym for its multifunctional capabilities: ventilation, oxygenation, cough assist, suction, and nebulizer treatments. Lastly, the VOCSN can disable leak compensation, which may be advantageous for enabling leak speech with a tracheostomy.
I just provided my patient with a Trilogy EVO. Do I need to change this immediately?
Dr. Coleman: No, but you should start conversations with your patient/caregiving support and with your durable medical equipment (DME) provider about alternative options. The ripple effects of the Philips Respironics recall will be ongoing for years. The silver lining of this situation is that there are numerous HMV options on the market currently. It is important to review the differences between these new devices and consider what will work best for your patient and your practice. In addition, it is critical that your DME provider is familiar with these new devices, both for support and education, and is taking steps to make alternate devices available. We anticipate a push in coming months to switch patients off Trilogy EVO, so it important to get this process started.
For patients not interested in switching just yet, Philips Respironics will continue to service and offer supplies for these devices for up to 5 years, depending on part availability (Table 1). Refer to the Philips Respironics Sleep & Respiratory Product Portfolio Changes website for the most up-to-date information.
I have a patient on AVAPS, and I must change to iVAPS. What now?
Dr. Lussier: As mentioned previously by Dr. Ackrivo, the ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. A download from a current VAPS setting can be helpful in defining target ventilation and pressure ranges for a tailored prescription. ResMed has an online iVAPS calculator (resmed.com) to assist in making this switch. Close clinical monitoring with data downloads is recommended to assure desired targets are still achieved.
What will happen to Philips Respironics’ cloud patient data?
Dr. Lussier: Representatives have reported that both providers and DME companies will have continued access to Care Orchestrator going forward. Currently, the logistics of data maintenance and ownership remain unclear, which poses additional questions about global access to patients’ data downloads.
----------
The recent discontinuation of Philips Respironics ventilation devices will induce a dramatic shift in home ventilation options in the US. Clinicians and DME companies should begin familiarizing themselves with alternative ventilators and their unique features. While significant uncertainty exists, we encourage a proactive approach to education and communication to ensure a smooth transition for patients on home ventilation.
John M. Coleman III, MD, FCCP, is Associate Professor, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine. Bethany L. Lussier, MD, FCCP, is in the Department of Internal Medicine, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Division of Neurocritical Care, UT Southwestern Medical Center. Jason Ackrivo, MD, is Assistant Professor of Medicine and Neurology, and Associate Director, Jay and Randy Fishman Program for Home Assisted Ventilation, Pulmonary, Allergy, and Critical Care Division, Perelman School of Medicine, University of Pennsylvania.
Specialist input on a sudden shift in device availability
Specialist input on a sudden shift in device availability
Philips Respironics released a public statement on January 25, 2024, that would dramatically change the landscape of home mechanical ventilation and sleep-disordered breathing management in the United States. The company announced that, effective immediately in the US and US territories, Philips Respironics would stop production and sale of all hospital and home mechanical ventilation products, home and hospital ventilation devices, and oxygen concentrators.
Why is this happening?
John M. Coleman III, MD, FCCP: To understand the current Philips Respironics announcement, we must go back to June 2021. At that time, Philips recalled certain home mechanical ventilators, CPAP machines, and BiPAP machines due to potential health risks related to breakdown of the polyester-based polyurethane (PE-PUR) foam placed in these devices for noise reduction. Small and microscopic particles of this foam were at risk for being inhaled or ingested by patients using these devices. It was suspected that inhalation of these particles could potentially result in temporary or permanent injury. Machines in hot temperatures or using ozone cleaning were at increased risk. The US Food and Drug Administration (FDA) issued a class 1 recall, defined as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
In the months following the initial recall, there were additional recalls of both in-hospital and home ventilators related to the potential of these foam particles to move and block the air path, reducing airflow and causing the device to alarm.
Over the next few years, tens of thousands of medical device reports were filed about PE-PUR foam-related injuries, with some cases resulting in death. At this time, the Department of Justice began collaborating with the FDA on a consent decree. There were ongoing recalls of the CoughAssist T70 device, as well as the newest generation of Philips Respironics home ventilators, the Trilogy EVO.
Ultimately, after years of ongoing recalls and reports of numerous deaths and injuries, with multiple class action lawsuits, the consent decree was finalized. Philips Respironics agreed to stop production of all respiratory-related products in the US and US territories.
What devices does this apply to?
Jason Ackrivo, MD: This notice affects the devices shown in Table 1. All sales and device shipments have been discontinued as of January 25, 2024. Philips Respironics will continue to service the devices, subject to part availability, up to 5 years after sales discontinuation. However, Philips Respironics will continue to sell consumables and accessories, including masks.
What are my options for home mechanical ventilators?
Bethany L. Lussier, MD, FCCP: In the US, alternative approved home mechanical ventilator (HMV) devices include Astral by ResMed, Vivo 45 and Vivo 65 by Breas, and VOCSN by Ventec. Additional options made available through emergency use authorization by the FDA between 2020 and 2022 included Luisa by Löwenstein Medical, the V+ by Ventec, and Life2000 by Baxter. Many of us expedite disposition from the hospital by prescribing HMVs rather than respiratory assist devices (RADs) because it is easier to meet qualifying criteria for insurance. In efforts to promote just allocation of resources, now might be the ideal time to reconsider higher utilization of RADs over HMVs. Reasonable RAD candidates are those who do not need autotitration of EPAP, dual mode therapy, or invasive ventilation. In these cases, the qualifying criteria and patient needs may be met with a RAD capable of VAPS or BPAP-ST mode.
How are these alternative devices similar to and different from the Trilogy EVO?
Dr. Ackrivo:All these devices are portable ventilators that can deliver noninvasive or invasive ventilation. They have internal batteries for enabling portability. They offer multiple programmable presets and mouthpiece ventilation, and some offer both oxygenation and CO2 monitoring (both TcCO2 and EtCO2).
All alternative portable ventilators include a proprietary ventilation mode analogous to the Trilogy AVAPS algorithm (Table 2). The ResMed Astral has a safety tidal volume feature that targets a minimum tidal volume in PS, S/T, or P(A)C modes. The ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. The Breas Vivo can target a tidal volume (TgV) in either PSV or PCV mode.
Unique ventilator characteristics are shown in Table 2. ResMed Astral mode options will differ between leak (passive) or valve (active) circuits. Both the Breas Vivo and Löwenstein Luisa enable high-flow oxygen delivery. Only the Breas Vivo enables connecting to a transcutaneous carbon dioxide monitor. The VOCSN name is an acronym for its multifunctional capabilities: ventilation, oxygenation, cough assist, suction, and nebulizer treatments. Lastly, the VOCSN can disable leak compensation, which may be advantageous for enabling leak speech with a tracheostomy.
I just provided my patient with a Trilogy EVO. Do I need to change this immediately?
Dr. Coleman: No, but you should start conversations with your patient/caregiving support and with your durable medical equipment (DME) provider about alternative options. The ripple effects of the Philips Respironics recall will be ongoing for years. The silver lining of this situation is that there are numerous HMV options on the market currently. It is important to review the differences between these new devices and consider what will work best for your patient and your practice. In addition, it is critical that your DME provider is familiar with these new devices, both for support and education, and is taking steps to make alternate devices available. We anticipate a push in coming months to switch patients off Trilogy EVO, so it important to get this process started.
For patients not interested in switching just yet, Philips Respironics will continue to service and offer supplies for these devices for up to 5 years, depending on part availability (Table 1). Refer to the Philips Respironics Sleep & Respiratory Product Portfolio Changes website for the most up-to-date information.
I have a patient on AVAPS, and I must change to iVAPS. What now?
Dr. Lussier: As mentioned previously by Dr. Ackrivo, the ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. A download from a current VAPS setting can be helpful in defining target ventilation and pressure ranges for a tailored prescription. ResMed has an online iVAPS calculator (resmed.com) to assist in making this switch. Close clinical monitoring with data downloads is recommended to assure desired targets are still achieved.
What will happen to Philips Respironics’ cloud patient data?
Dr. Lussier: Representatives have reported that both providers and DME companies will have continued access to Care Orchestrator going forward. Currently, the logistics of data maintenance and ownership remain unclear, which poses additional questions about global access to patients’ data downloads.
----------
The recent discontinuation of Philips Respironics ventilation devices will induce a dramatic shift in home ventilation options in the US. Clinicians and DME companies should begin familiarizing themselves with alternative ventilators and their unique features. While significant uncertainty exists, we encourage a proactive approach to education and communication to ensure a smooth transition for patients on home ventilation.
John M. Coleman III, MD, FCCP, is Associate Professor, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine. Bethany L. Lussier, MD, FCCP, is in the Department of Internal Medicine, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Division of Neurocritical Care, UT Southwestern Medical Center. Jason Ackrivo, MD, is Assistant Professor of Medicine and Neurology, and Associate Director, Jay and Randy Fishman Program for Home Assisted Ventilation, Pulmonary, Allergy, and Critical Care Division, Perelman School of Medicine, University of Pennsylvania.
Philips Respironics released a public statement on January 25, 2024, that would dramatically change the landscape of home mechanical ventilation and sleep-disordered breathing management in the United States. The company announced that, effective immediately in the US and US territories, Philips Respironics would stop production and sale of all hospital and home mechanical ventilation products, home and hospital ventilation devices, and oxygen concentrators.
Why is this happening?
John M. Coleman III, MD, FCCP: To understand the current Philips Respironics announcement, we must go back to June 2021. At that time, Philips recalled certain home mechanical ventilators, CPAP machines, and BiPAP machines due to potential health risks related to breakdown of the polyester-based polyurethane (PE-PUR) foam placed in these devices for noise reduction. Small and microscopic particles of this foam were at risk for being inhaled or ingested by patients using these devices. It was suspected that inhalation of these particles could potentially result in temporary or permanent injury. Machines in hot temperatures or using ozone cleaning were at increased risk. The US Food and Drug Administration (FDA) issued a class 1 recall, defined as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
In the months following the initial recall, there were additional recalls of both in-hospital and home ventilators related to the potential of these foam particles to move and block the air path, reducing airflow and causing the device to alarm.
Over the next few years, tens of thousands of medical device reports were filed about PE-PUR foam-related injuries, with some cases resulting in death. At this time, the Department of Justice began collaborating with the FDA on a consent decree. There were ongoing recalls of the CoughAssist T70 device, as well as the newest generation of Philips Respironics home ventilators, the Trilogy EVO.
Ultimately, after years of ongoing recalls and reports of numerous deaths and injuries, with multiple class action lawsuits, the consent decree was finalized. Philips Respironics agreed to stop production of all respiratory-related products in the US and US territories.
What devices does this apply to?
Jason Ackrivo, MD: This notice affects the devices shown in Table 1. All sales and device shipments have been discontinued as of January 25, 2024. Philips Respironics will continue to service the devices, subject to part availability, up to 5 years after sales discontinuation. However, Philips Respironics will continue to sell consumables and accessories, including masks.
What are my options for home mechanical ventilators?
Bethany L. Lussier, MD, FCCP: In the US, alternative approved home mechanical ventilator (HMV) devices include Astral by ResMed, Vivo 45 and Vivo 65 by Breas, and VOCSN by Ventec. Additional options made available through emergency use authorization by the FDA between 2020 and 2022 included Luisa by Löwenstein Medical, the V+ by Ventec, and Life2000 by Baxter. Many of us expedite disposition from the hospital by prescribing HMVs rather than respiratory assist devices (RADs) because it is easier to meet qualifying criteria for insurance. In efforts to promote just allocation of resources, now might be the ideal time to reconsider higher utilization of RADs over HMVs. Reasonable RAD candidates are those who do not need autotitration of EPAP, dual mode therapy, or invasive ventilation. In these cases, the qualifying criteria and patient needs may be met with a RAD capable of VAPS or BPAP-ST mode.
How are these alternative devices similar to and different from the Trilogy EVO?
Dr. Ackrivo:All these devices are portable ventilators that can deliver noninvasive or invasive ventilation. They have internal batteries for enabling portability. They offer multiple programmable presets and mouthpiece ventilation, and some offer both oxygenation and CO2 monitoring (both TcCO2 and EtCO2).
All alternative portable ventilators include a proprietary ventilation mode analogous to the Trilogy AVAPS algorithm (Table 2). The ResMed Astral has a safety tidal volume feature that targets a minimum tidal volume in PS, S/T, or P(A)C modes. The ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. The Breas Vivo can target a tidal volume (TgV) in either PSV or PCV mode.
Unique ventilator characteristics are shown in Table 2. ResMed Astral mode options will differ between leak (passive) or valve (active) circuits. Both the Breas Vivo and Löwenstein Luisa enable high-flow oxygen delivery. Only the Breas Vivo enables connecting to a transcutaneous carbon dioxide monitor. The VOCSN name is an acronym for its multifunctional capabilities: ventilation, oxygenation, cough assist, suction, and nebulizer treatments. Lastly, the VOCSN can disable leak compensation, which may be advantageous for enabling leak speech with a tracheostomy.
I just provided my patient with a Trilogy EVO. Do I need to change this immediately?
Dr. Coleman: No, but you should start conversations with your patient/caregiving support and with your durable medical equipment (DME) provider about alternative options. The ripple effects of the Philips Respironics recall will be ongoing for years. The silver lining of this situation is that there are numerous HMV options on the market currently. It is important to review the differences between these new devices and consider what will work best for your patient and your practice. In addition, it is critical that your DME provider is familiar with these new devices, both for support and education, and is taking steps to make alternate devices available. We anticipate a push in coming months to switch patients off Trilogy EVO, so it important to get this process started.
For patients not interested in switching just yet, Philips Respironics will continue to service and offer supplies for these devices for up to 5 years, depending on part availability (Table 1). Refer to the Philips Respironics Sleep & Respiratory Product Portfolio Changes website for the most up-to-date information.
I have a patient on AVAPS, and I must change to iVAPS. What now?
Dr. Lussier: As mentioned previously by Dr. Ackrivo, the ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. A download from a current VAPS setting can be helpful in defining target ventilation and pressure ranges for a tailored prescription. ResMed has an online iVAPS calculator (resmed.com) to assist in making this switch. Close clinical monitoring with data downloads is recommended to assure desired targets are still achieved.
What will happen to Philips Respironics’ cloud patient data?
Dr. Lussier: Representatives have reported that both providers and DME companies will have continued access to Care Orchestrator going forward. Currently, the logistics of data maintenance and ownership remain unclear, which poses additional questions about global access to patients’ data downloads.
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The recent discontinuation of Philips Respironics ventilation devices will induce a dramatic shift in home ventilation options in the US. Clinicians and DME companies should begin familiarizing themselves with alternative ventilators and their unique features. While significant uncertainty exists, we encourage a proactive approach to education and communication to ensure a smooth transition for patients on home ventilation.
John M. Coleman III, MD, FCCP, is Associate Professor, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine. Bethany L. Lussier, MD, FCCP, is in the Department of Internal Medicine, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Division of Neurocritical Care, UT Southwestern Medical Center. Jason Ackrivo, MD, is Assistant Professor of Medicine and Neurology, and Associate Director, Jay and Randy Fishman Program for Home Assisted Ventilation, Pulmonary, Allergy, and Critical Care Division, Perelman School of Medicine, University of Pennsylvania.
Making invisible problems visible
How Erika Mosesón, MD, educates on the effects of air pollution and encourages community-level advocacy
For Erika Mosesón, MD, a pulmonologist and ICU doctor, advocacy for clean air and climate action started small: signing petitions and writing letters.
Even as she attended conferences and learned about the health impacts of air pollution, her impression was that experts were handling it. “I didn’t really think my voice was worth highlighting,” Dr. Mosesón said.
But her concerns grew with the repeal of the Clean Power Plan in 2019 and rolled-back federal protections around particulate matter and other environmental guidelines.
In response, Dr. Mosesón moved from writing letters to educating people in her home state of Oregon on the lung-related effects of pollution. She spoke at organization meetings and town halls and met with legislators. One way or another, she knew she needed to get the word out.
After all, problem-causing particulates are teeny-tiny; too small to be seen. “It’s literally invisible,” Dr. Mosesón said. But the impact on patients is not.
That’s how the Air Health Our Health podcast was born.
The podcast has a straightforward tagline — ”Clean air saves lives” — and a blunt recommendation: “If you do nothing else, don’t light things on fire and breathe them into your lungs.”
Giving a voice to the voiceless
In early 2017, the Oregon legislature was considering bills aimed at transitioning from diesel-fueled engines to cleaner alternatives. At the time, Dr. Mosesón was on the executive committee for the Oregon Thoracic Society, and, in partnership with the American Lung Association, she was tapped to speak to legislators about clean air and the health impacts of air pollution.
This role made it clear to her that lawmakers don’t hear diverse perspectives. A trucking company may budget for full-time lobbyists, whereas parents of kids with asthma aren’t in the room.
So there’s an asymmetry to who is and is not heard from, Dr. Mosesón said. That’s why in her conversations and presentations, she advocates for those who might not otherwise be represented in the rooms where big decisions are made.
Automating advocacy
Over time, Dr. Mosesón found her schedule was filling up with meetings and presentations.
“I’m a full-time clinician,” Dr. Mosesón noted. She’s also a parent to three kids. When she was asked to attend a hearing, sometimes her schedule required her to decline. And so, early in the pandemic, the Air Health Our Health podcast and the accompanying website were born.
“The podcast and website were honestly a way to automate advocacy,” Dr. Mosesón said.
In many ways, the pandemic was an ideal time to launch the podcast. For one thing, the idea of podcasting from your closet or living room (as opposed to a professional audio studio) became commonplace. Plus, for a pulmonologist, these years were full of relevant topics like how climate change and particulate matter interacted with COVID-19 , Dr. Mosesón noted.
Then, in 2020, the Labor Day fires led to Oregon’s having the worst air quality in the world. That same year, there were George Floyd protests around the country, including in Portland, which led to rampant use of tear gas and prompted Dr. Mosesón to dig into studies about these chemicals.
Given just how much air pollution affects health — and the continued extreme weather events (such as Oregon’s heat dome in summer 2021) — there was no shortage of topics for the podcast.
Next steps to empower physicians
Confronting climate change is daunting, and it is made more challenging by a partisan environment, distrust of experts, and disinformation. On her podcast, Dr. Mosesón aims to make it easier.
In each episode, she shares information and interviews experts. She shares how a patient might be affected by particular issues — radon, wildfires, and so on. The goal is to provide clinicians with a foundation on everyday issues.
“Every single doctor feels like they can talk to a patient about smoking, even if they don’t know all the deep nitty-gritty studies about it,” Dr. Mosesón said. The exact effects of smoking — cancer, heart disease, and lung disease — occur due to air pollution. “When I give talks, I tell people, if you can talk about smoking, you can talk about air pollution.”
Each podcast also features an array of action items.
Some steps are practical, such as creating a plan for heat events or encouraging radon testing. The solution could also be as simple as asking the right questions.
For example, at a doctor’s visit for asthma, common recommendations are to use a HEPA filter or place a sheet protector on the bed, Dr. Mosesón said. It won’t typically come up that a patient’s asthma may be caused or exacerbated by living beside a highway.
Dr. Mosesón also encourages advocacy. “There are all these different levels [of response],” she said. Next steps might involve writing a letter, contacting a councilperson, or advocating for a program (like retiring gas-powered leaf blowers).
For many patients, their doctor is the only person they routinely interact with who has advanced scientific training. Rather than presenting dry data, Dr. Mosesón recommends framing changes and recommendations in ways that are meaningful to neighbors.
“Each physician or clinician is going to know the values of their community,” Dr. Mosesón said. If you’re in a military town, advocating for electric cars may be easier if framed around decreasing dependence on foreign oil. If the region recently experienced back-to-back heat events, advocating for a cooling center might be galvanizing.
What is Dr. Mosesón’s ultimate goal? Inform others so well that she can retire her podcasting equipment.
“I would love,” Dr. Mosesón said, “for every physician in their local community to be a clean air and climate advocate.”
------
Be sure to check out a special episode of the Air Health Our Health podcast, where Dr. Mosesón and CHEST Advocates Editor in Chief, Drew Harris, MD, FCCP, discuss the serious health issues impacting coal miners. They take a deep dive into black lung disease and silica dust, highlighting the science and research, prevention efforts and challenges to implementation, and the importance of advocacy work.
LISTEN NOW »
This article was adapted from the Winter 2024 online issue of CHEST Advocates. For the full article — and to engage with the other content from this issue — visit chestnet.org/chest-advocates.
How Erika Mosesón, MD, educates on the effects of air pollution and encourages community-level advocacy
How Erika Mosesón, MD, educates on the effects of air pollution and encourages community-level advocacy
For Erika Mosesón, MD, a pulmonologist and ICU doctor, advocacy for clean air and climate action started small: signing petitions and writing letters.
Even as she attended conferences and learned about the health impacts of air pollution, her impression was that experts were handling it. “I didn’t really think my voice was worth highlighting,” Dr. Mosesón said.
But her concerns grew with the repeal of the Clean Power Plan in 2019 and rolled-back federal protections around particulate matter and other environmental guidelines.
In response, Dr. Mosesón moved from writing letters to educating people in her home state of Oregon on the lung-related effects of pollution. She spoke at organization meetings and town halls and met with legislators. One way or another, she knew she needed to get the word out.
After all, problem-causing particulates are teeny-tiny; too small to be seen. “It’s literally invisible,” Dr. Mosesón said. But the impact on patients is not.
That’s how the Air Health Our Health podcast was born.
The podcast has a straightforward tagline — ”Clean air saves lives” — and a blunt recommendation: “If you do nothing else, don’t light things on fire and breathe them into your lungs.”
Giving a voice to the voiceless
In early 2017, the Oregon legislature was considering bills aimed at transitioning from diesel-fueled engines to cleaner alternatives. At the time, Dr. Mosesón was on the executive committee for the Oregon Thoracic Society, and, in partnership with the American Lung Association, she was tapped to speak to legislators about clean air and the health impacts of air pollution.
This role made it clear to her that lawmakers don’t hear diverse perspectives. A trucking company may budget for full-time lobbyists, whereas parents of kids with asthma aren’t in the room.
So there’s an asymmetry to who is and is not heard from, Dr. Mosesón said. That’s why in her conversations and presentations, she advocates for those who might not otherwise be represented in the rooms where big decisions are made.
Automating advocacy
Over time, Dr. Mosesón found her schedule was filling up with meetings and presentations.
“I’m a full-time clinician,” Dr. Mosesón noted. She’s also a parent to three kids. When she was asked to attend a hearing, sometimes her schedule required her to decline. And so, early in the pandemic, the Air Health Our Health podcast and the accompanying website were born.
“The podcast and website were honestly a way to automate advocacy,” Dr. Mosesón said.
In many ways, the pandemic was an ideal time to launch the podcast. For one thing, the idea of podcasting from your closet or living room (as opposed to a professional audio studio) became commonplace. Plus, for a pulmonologist, these years were full of relevant topics like how climate change and particulate matter interacted with COVID-19 , Dr. Mosesón noted.
Then, in 2020, the Labor Day fires led to Oregon’s having the worst air quality in the world. That same year, there were George Floyd protests around the country, including in Portland, which led to rampant use of tear gas and prompted Dr. Mosesón to dig into studies about these chemicals.
Given just how much air pollution affects health — and the continued extreme weather events (such as Oregon’s heat dome in summer 2021) — there was no shortage of topics for the podcast.
Next steps to empower physicians
Confronting climate change is daunting, and it is made more challenging by a partisan environment, distrust of experts, and disinformation. On her podcast, Dr. Mosesón aims to make it easier.
In each episode, she shares information and interviews experts. She shares how a patient might be affected by particular issues — radon, wildfires, and so on. The goal is to provide clinicians with a foundation on everyday issues.
“Every single doctor feels like they can talk to a patient about smoking, even if they don’t know all the deep nitty-gritty studies about it,” Dr. Mosesón said. The exact effects of smoking — cancer, heart disease, and lung disease — occur due to air pollution. “When I give talks, I tell people, if you can talk about smoking, you can talk about air pollution.”
Each podcast also features an array of action items.
Some steps are practical, such as creating a plan for heat events or encouraging radon testing. The solution could also be as simple as asking the right questions.
For example, at a doctor’s visit for asthma, common recommendations are to use a HEPA filter or place a sheet protector on the bed, Dr. Mosesón said. It won’t typically come up that a patient’s asthma may be caused or exacerbated by living beside a highway.
Dr. Mosesón also encourages advocacy. “There are all these different levels [of response],” she said. Next steps might involve writing a letter, contacting a councilperson, or advocating for a program (like retiring gas-powered leaf blowers).
For many patients, their doctor is the only person they routinely interact with who has advanced scientific training. Rather than presenting dry data, Dr. Mosesón recommends framing changes and recommendations in ways that are meaningful to neighbors.
“Each physician or clinician is going to know the values of their community,” Dr. Mosesón said. If you’re in a military town, advocating for electric cars may be easier if framed around decreasing dependence on foreign oil. If the region recently experienced back-to-back heat events, advocating for a cooling center might be galvanizing.
What is Dr. Mosesón’s ultimate goal? Inform others so well that she can retire her podcasting equipment.
“I would love,” Dr. Mosesón said, “for every physician in their local community to be a clean air and climate advocate.”
------
Be sure to check out a special episode of the Air Health Our Health podcast, where Dr. Mosesón and CHEST Advocates Editor in Chief, Drew Harris, MD, FCCP, discuss the serious health issues impacting coal miners. They take a deep dive into black lung disease and silica dust, highlighting the science and research, prevention efforts and challenges to implementation, and the importance of advocacy work.
LISTEN NOW »
This article was adapted from the Winter 2024 online issue of CHEST Advocates. For the full article — and to engage with the other content from this issue — visit chestnet.org/chest-advocates.
For Erika Mosesón, MD, a pulmonologist and ICU doctor, advocacy for clean air and climate action started small: signing petitions and writing letters.
Even as she attended conferences and learned about the health impacts of air pollution, her impression was that experts were handling it. “I didn’t really think my voice was worth highlighting,” Dr. Mosesón said.
But her concerns grew with the repeal of the Clean Power Plan in 2019 and rolled-back federal protections around particulate matter and other environmental guidelines.
In response, Dr. Mosesón moved from writing letters to educating people in her home state of Oregon on the lung-related effects of pollution. She spoke at organization meetings and town halls and met with legislators. One way or another, she knew she needed to get the word out.
After all, problem-causing particulates are teeny-tiny; too small to be seen. “It’s literally invisible,” Dr. Mosesón said. But the impact on patients is not.
That’s how the Air Health Our Health podcast was born.
The podcast has a straightforward tagline — ”Clean air saves lives” — and a blunt recommendation: “If you do nothing else, don’t light things on fire and breathe them into your lungs.”
Giving a voice to the voiceless
In early 2017, the Oregon legislature was considering bills aimed at transitioning from diesel-fueled engines to cleaner alternatives. At the time, Dr. Mosesón was on the executive committee for the Oregon Thoracic Society, and, in partnership with the American Lung Association, she was tapped to speak to legislators about clean air and the health impacts of air pollution.
This role made it clear to her that lawmakers don’t hear diverse perspectives. A trucking company may budget for full-time lobbyists, whereas parents of kids with asthma aren’t in the room.
So there’s an asymmetry to who is and is not heard from, Dr. Mosesón said. That’s why in her conversations and presentations, she advocates for those who might not otherwise be represented in the rooms where big decisions are made.
Automating advocacy
Over time, Dr. Mosesón found her schedule was filling up with meetings and presentations.
“I’m a full-time clinician,” Dr. Mosesón noted. She’s also a parent to three kids. When she was asked to attend a hearing, sometimes her schedule required her to decline. And so, early in the pandemic, the Air Health Our Health podcast and the accompanying website were born.
“The podcast and website were honestly a way to automate advocacy,” Dr. Mosesón said.
In many ways, the pandemic was an ideal time to launch the podcast. For one thing, the idea of podcasting from your closet or living room (as opposed to a professional audio studio) became commonplace. Plus, for a pulmonologist, these years were full of relevant topics like how climate change and particulate matter interacted with COVID-19 , Dr. Mosesón noted.
Then, in 2020, the Labor Day fires led to Oregon’s having the worst air quality in the world. That same year, there were George Floyd protests around the country, including in Portland, which led to rampant use of tear gas and prompted Dr. Mosesón to dig into studies about these chemicals.
Given just how much air pollution affects health — and the continued extreme weather events (such as Oregon’s heat dome in summer 2021) — there was no shortage of topics for the podcast.
Next steps to empower physicians
Confronting climate change is daunting, and it is made more challenging by a partisan environment, distrust of experts, and disinformation. On her podcast, Dr. Mosesón aims to make it easier.
In each episode, she shares information and interviews experts. She shares how a patient might be affected by particular issues — radon, wildfires, and so on. The goal is to provide clinicians with a foundation on everyday issues.
“Every single doctor feels like they can talk to a patient about smoking, even if they don’t know all the deep nitty-gritty studies about it,” Dr. Mosesón said. The exact effects of smoking — cancer, heart disease, and lung disease — occur due to air pollution. “When I give talks, I tell people, if you can talk about smoking, you can talk about air pollution.”
Each podcast also features an array of action items.
Some steps are practical, such as creating a plan for heat events or encouraging radon testing. The solution could also be as simple as asking the right questions.
For example, at a doctor’s visit for asthma, common recommendations are to use a HEPA filter or place a sheet protector on the bed, Dr. Mosesón said. It won’t typically come up that a patient’s asthma may be caused or exacerbated by living beside a highway.
Dr. Mosesón also encourages advocacy. “There are all these different levels [of response],” she said. Next steps might involve writing a letter, contacting a councilperson, or advocating for a program (like retiring gas-powered leaf blowers).
For many patients, their doctor is the only person they routinely interact with who has advanced scientific training. Rather than presenting dry data, Dr. Mosesón recommends framing changes and recommendations in ways that are meaningful to neighbors.
“Each physician or clinician is going to know the values of their community,” Dr. Mosesón said. If you’re in a military town, advocating for electric cars may be easier if framed around decreasing dependence on foreign oil. If the region recently experienced back-to-back heat events, advocating for a cooling center might be galvanizing.
What is Dr. Mosesón’s ultimate goal? Inform others so well that she can retire her podcasting equipment.
“I would love,” Dr. Mosesón said, “for every physician in their local community to be a clean air and climate advocate.”
------
Be sure to check out a special episode of the Air Health Our Health podcast, where Dr. Mosesón and CHEST Advocates Editor in Chief, Drew Harris, MD, FCCP, discuss the serious health issues impacting coal miners. They take a deep dive into black lung disease and silica dust, highlighting the science and research, prevention efforts and challenges to implementation, and the importance of advocacy work.
LISTEN NOW »
This article was adapted from the Winter 2024 online issue of CHEST Advocates. For the full article — and to engage with the other content from this issue — visit chestnet.org/chest-advocates.