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ACOG supports delayed umbilical cord clamping for term infants
The American College of Obstetricians and Gynecologists recommends that umbilical cord clamping be delayed for at least 30-60 seconds after birth in vigorous preterm and term infants.
Since early studies suggested that up to 90% of the blood transfer from the placenta to the newborn after birth happens with an infant’s first few breaths, it has become common practice to clamp the cord within 15-20 seconds after birth.
In 2012, the ACOG Committee on Obstetric Practice recommended use of delayed umbilical cord clamping in preterm infants, but found a lack of evidence in term infants. “However, more recent randomized controlled trials of term and preterm infants as well as physiologic studies of blood volume, oxygenation, and arterial pressure have evaluated the effects of immediate versus delayed umbilical cord clamping (usually defined as cord clamping at least 30-60 seconds after birth),” wrote the members of the College’s Committee on Obstetric Practice in an updated opinion released on Dec. 21.
These studies showed that around 80 mL of blood is transferred from the placenta within 1 minute of birth, which appears to be facilitated by the newborn’s initial breaths. This initial transfer of blood supplies significant quantities of iron – 40-50 mg/kg of body weight - and is associated with a lower risk of iron deficiency during the first year of life (Obstet Gynecol. 2017;129:e5-10).
The committee cited a 2012 systematic review of the data on preterm infants that found a 39% reduction in the number of infants requiring transfusion for anemia when delayed umbilical cord clamping – defined as a delay of 30-180 seconds – was used, compared with immediate clamping. The review also noted a 41% reduction in the incidence of intraventricular hemorrhage and 38% reduction in necrotizing enterocolitis, compared with immediate umbilical cord clamping.
Similarly in term infants, those who had their umbilical cord clamped early showed significantly lower hemoglobin concentrations at birth and were more likely to have iron deficiency at 3-6 months of age, compared with term infants who had delayed clamping.
The committee did note that preterm infants who experienced delayed cord clamping showed higher peak bilirubin levels, compared with early clamping. In term infants, delayed cord clamping was associated with a small increase in the incidence of jaundice requiring phototherapy, although there were no significant differences in the rates of polycythemia or jaundice overall.
“Consequently, obstetrician-gynecologists and other obstetric care providers adopting delayed cord clamping in term infants should ensure that mechanisms are in place to monitor for and treat neonatal jaundice,” the committee members wrote.
With regards to maternal outcomes, there had been concerns that delayed umbilical cord clamping could increase the risk of maternal hemorrhage. But a review of five trials including more than 2,200 women found no sign of an increase in adverse events such as postpartum hemorrhage, increased blood loss at delivery, blood transfusions, or reduced postpartum hemoglobin levels.
“However, when there is increased risk of hemorrhage (e.g., placenta previa or placental abruption), the benefits of delayed umbilical cord clamping need to be balanced with the need for timely hemodynamic stabilization of the woman,” the authors wrote.
The committee found that skin-to-skin care could still take place with delayed umbilical cord clamping, as gravity was not necessary to facilitate the flow of blood from the placenta to the newborn. They also advised that early care of the newborn could still be carried out, including drying and stimulating for the first breath.
Delayed umbilical cord clamping should also not interfere with active management of the third stage of labor, including the use of uterotonic agents after delivery.
The authors reported having no conflicts of interest.
The American College of Obstetricians and Gynecologists recommends that umbilical cord clamping be delayed for at least 30-60 seconds after birth in vigorous preterm and term infants.
Since early studies suggested that up to 90% of the blood transfer from the placenta to the newborn after birth happens with an infant’s first few breaths, it has become common practice to clamp the cord within 15-20 seconds after birth.
In 2012, the ACOG Committee on Obstetric Practice recommended use of delayed umbilical cord clamping in preterm infants, but found a lack of evidence in term infants. “However, more recent randomized controlled trials of term and preterm infants as well as physiologic studies of blood volume, oxygenation, and arterial pressure have evaluated the effects of immediate versus delayed umbilical cord clamping (usually defined as cord clamping at least 30-60 seconds after birth),” wrote the members of the College’s Committee on Obstetric Practice in an updated opinion released on Dec. 21.
These studies showed that around 80 mL of blood is transferred from the placenta within 1 minute of birth, which appears to be facilitated by the newborn’s initial breaths. This initial transfer of blood supplies significant quantities of iron – 40-50 mg/kg of body weight - and is associated with a lower risk of iron deficiency during the first year of life (Obstet Gynecol. 2017;129:e5-10).
The committee cited a 2012 systematic review of the data on preterm infants that found a 39% reduction in the number of infants requiring transfusion for anemia when delayed umbilical cord clamping – defined as a delay of 30-180 seconds – was used, compared with immediate clamping. The review also noted a 41% reduction in the incidence of intraventricular hemorrhage and 38% reduction in necrotizing enterocolitis, compared with immediate umbilical cord clamping.
Similarly in term infants, those who had their umbilical cord clamped early showed significantly lower hemoglobin concentrations at birth and were more likely to have iron deficiency at 3-6 months of age, compared with term infants who had delayed clamping.
The committee did note that preterm infants who experienced delayed cord clamping showed higher peak bilirubin levels, compared with early clamping. In term infants, delayed cord clamping was associated with a small increase in the incidence of jaundice requiring phototherapy, although there were no significant differences in the rates of polycythemia or jaundice overall.
“Consequently, obstetrician-gynecologists and other obstetric care providers adopting delayed cord clamping in term infants should ensure that mechanisms are in place to monitor for and treat neonatal jaundice,” the committee members wrote.
With regards to maternal outcomes, there had been concerns that delayed umbilical cord clamping could increase the risk of maternal hemorrhage. But a review of five trials including more than 2,200 women found no sign of an increase in adverse events such as postpartum hemorrhage, increased blood loss at delivery, blood transfusions, or reduced postpartum hemoglobin levels.
“However, when there is increased risk of hemorrhage (e.g., placenta previa or placental abruption), the benefits of delayed umbilical cord clamping need to be balanced with the need for timely hemodynamic stabilization of the woman,” the authors wrote.
The committee found that skin-to-skin care could still take place with delayed umbilical cord clamping, as gravity was not necessary to facilitate the flow of blood from the placenta to the newborn. They also advised that early care of the newborn could still be carried out, including drying and stimulating for the first breath.
Delayed umbilical cord clamping should also not interfere with active management of the third stage of labor, including the use of uterotonic agents after delivery.
The authors reported having no conflicts of interest.
The American College of Obstetricians and Gynecologists recommends that umbilical cord clamping be delayed for at least 30-60 seconds after birth in vigorous preterm and term infants.
Since early studies suggested that up to 90% of the blood transfer from the placenta to the newborn after birth happens with an infant’s first few breaths, it has become common practice to clamp the cord within 15-20 seconds after birth.
In 2012, the ACOG Committee on Obstetric Practice recommended use of delayed umbilical cord clamping in preterm infants, but found a lack of evidence in term infants. “However, more recent randomized controlled trials of term and preterm infants as well as physiologic studies of blood volume, oxygenation, and arterial pressure have evaluated the effects of immediate versus delayed umbilical cord clamping (usually defined as cord clamping at least 30-60 seconds after birth),” wrote the members of the College’s Committee on Obstetric Practice in an updated opinion released on Dec. 21.
These studies showed that around 80 mL of blood is transferred from the placenta within 1 minute of birth, which appears to be facilitated by the newborn’s initial breaths. This initial transfer of blood supplies significant quantities of iron – 40-50 mg/kg of body weight - and is associated with a lower risk of iron deficiency during the first year of life (Obstet Gynecol. 2017;129:e5-10).
The committee cited a 2012 systematic review of the data on preterm infants that found a 39% reduction in the number of infants requiring transfusion for anemia when delayed umbilical cord clamping – defined as a delay of 30-180 seconds – was used, compared with immediate clamping. The review also noted a 41% reduction in the incidence of intraventricular hemorrhage and 38% reduction in necrotizing enterocolitis, compared with immediate umbilical cord clamping.
Similarly in term infants, those who had their umbilical cord clamped early showed significantly lower hemoglobin concentrations at birth and were more likely to have iron deficiency at 3-6 months of age, compared with term infants who had delayed clamping.
The committee did note that preterm infants who experienced delayed cord clamping showed higher peak bilirubin levels, compared with early clamping. In term infants, delayed cord clamping was associated with a small increase in the incidence of jaundice requiring phototherapy, although there were no significant differences in the rates of polycythemia or jaundice overall.
“Consequently, obstetrician-gynecologists and other obstetric care providers adopting delayed cord clamping in term infants should ensure that mechanisms are in place to monitor for and treat neonatal jaundice,” the committee members wrote.
With regards to maternal outcomes, there had been concerns that delayed umbilical cord clamping could increase the risk of maternal hemorrhage. But a review of five trials including more than 2,200 women found no sign of an increase in adverse events such as postpartum hemorrhage, increased blood loss at delivery, blood transfusions, or reduced postpartum hemoglobin levels.
“However, when there is increased risk of hemorrhage (e.g., placenta previa or placental abruption), the benefits of delayed umbilical cord clamping need to be balanced with the need for timely hemodynamic stabilization of the woman,” the authors wrote.
The committee found that skin-to-skin care could still take place with delayed umbilical cord clamping, as gravity was not necessary to facilitate the flow of blood from the placenta to the newborn. They also advised that early care of the newborn could still be carried out, including drying and stimulating for the first breath.
Delayed umbilical cord clamping should also not interfere with active management of the third stage of labor, including the use of uterotonic agents after delivery.
The authors reported having no conflicts of interest.
Shorter-course antimicrobials do not reduce antimicrobial resistance in AOM
A shorter duration of antimicrobial therapy for acute otitis media (AOM) in children is associated with higher rates of clinical failure and higher symptom scores but without any associated reduction in the rates of antimicrobial resistance or adverse events.
Alejandro Hoberman, MD, of the Children’s Hospital of Pittsburgh at the University of Pittsburgh Medical Center, and his coauthors report the results of a study in which 520 children aged 6-23 months were randomized to either 10 days of amoxicillin-clavulanate therapy, or 5 days of therapy followed by 5 days of placebo.
The children who received the full 10-day course also had lower mean symptom scores in the 6-14 days after initiation of therapy, compared with those who received 5 days of treatment (1.34 vs. 1.61; P = 0.07), while the number of children whose symptom scores decreased by 50% from baseline to the end of treatment was significantly lower in the 5-day group.
However, there were no significant differences between the two groups in the rate of nasopharyngeal colonization pathogens not susceptible to penicillin: 47% in the 10-day group, compared with 44% in the 5-day group (N Engl J Med. 2016 Dec 22;375[25]:2446-56).
Similarly, the rates of recurrence and adverse events were not significantly different between the two groups.
A shorter duration of treatment has been considered as a strategy for reducing the risk of antimicrobial resistance, but clinical trials so far have showed either modest difference favoring the standard duration of treatment, or no difference at all.
“The outcome differences we found were larger than the differences that have been reported previously, mainly because the rates of clinical failure among children who received reduced duration treatment were higher in our trial than in previous trials,” Dr. Hoberman and his associates wrote.
The researchers did note that clinical failure rates were higher among children with greater exposure to other children, and those with infection in both ears rather than a single ear.
The study was supported by the National Institute of Allergy and Infectious Diseases and the National Institutes of Health. Dr. Hoberman and Dr. Judith M. Martin declared consulting fees from Genocea Biosciences, and Dr. Hoberman declared grant support from Ricoh Innovations and holding pending patents for a reduced clavulanate concentration version of amoxicillin–clavulanate potassium, and a method and device for aiding in the diagnosis of otitis media. No other conflicts of interest were declared.
The study of acute otitis media is challenging owing to antibiotic pharmacokinetics, age of the patients, variation in regional pathogens, polymicrobial infection, viral cofactors, antibiotic resistance, status of patients with regard to receipt of PCV7 or PCV13, and a high rate of spontaneous resolution.
The study was not designed to address outcomes in older children, children with less severe acute otitis media or with acute otitis media in one ear, or children with additional risk factors such as cleft palate or trisomy 21. In addition, there is a paucity of studies from resource-poor and low income countries.
But for now, 10 days of amoxicillin-clavulanate for children younger than 2 years of age who have a definite diagnosis of acute otitis media seems to be a reasonable option.
Margaret A. Kenna, MD, MPH, is from the department of otolaryngology and communication enhancement at the Boston Children’s Hospital. These comments are excerpted from an accompanying editorial (N Engl J Med. 2016 Dec 22;375[25]:2492-93). Dr. Kenna declared a grant from Agilis outside the submitted work.
The study of acute otitis media is challenging owing to antibiotic pharmacokinetics, age of the patients, variation in regional pathogens, polymicrobial infection, viral cofactors, antibiotic resistance, status of patients with regard to receipt of PCV7 or PCV13, and a high rate of spontaneous resolution.
The study was not designed to address outcomes in older children, children with less severe acute otitis media or with acute otitis media in one ear, or children with additional risk factors such as cleft palate or trisomy 21. In addition, there is a paucity of studies from resource-poor and low income countries.
But for now, 10 days of amoxicillin-clavulanate for children younger than 2 years of age who have a definite diagnosis of acute otitis media seems to be a reasonable option.
Margaret A. Kenna, MD, MPH, is from the department of otolaryngology and communication enhancement at the Boston Children’s Hospital. These comments are excerpted from an accompanying editorial (N Engl J Med. 2016 Dec 22;375[25]:2492-93). Dr. Kenna declared a grant from Agilis outside the submitted work.
The study of acute otitis media is challenging owing to antibiotic pharmacokinetics, age of the patients, variation in regional pathogens, polymicrobial infection, viral cofactors, antibiotic resistance, status of patients with regard to receipt of PCV7 or PCV13, and a high rate of spontaneous resolution.
The study was not designed to address outcomes in older children, children with less severe acute otitis media or with acute otitis media in one ear, or children with additional risk factors such as cleft palate or trisomy 21. In addition, there is a paucity of studies from resource-poor and low income countries.
But for now, 10 days of amoxicillin-clavulanate for children younger than 2 years of age who have a definite diagnosis of acute otitis media seems to be a reasonable option.
Margaret A. Kenna, MD, MPH, is from the department of otolaryngology and communication enhancement at the Boston Children’s Hospital. These comments are excerpted from an accompanying editorial (N Engl J Med. 2016 Dec 22;375[25]:2492-93). Dr. Kenna declared a grant from Agilis outside the submitted work.
A shorter duration of antimicrobial therapy for acute otitis media (AOM) in children is associated with higher rates of clinical failure and higher symptom scores but without any associated reduction in the rates of antimicrobial resistance or adverse events.
Alejandro Hoberman, MD, of the Children’s Hospital of Pittsburgh at the University of Pittsburgh Medical Center, and his coauthors report the results of a study in which 520 children aged 6-23 months were randomized to either 10 days of amoxicillin-clavulanate therapy, or 5 days of therapy followed by 5 days of placebo.
The children who received the full 10-day course also had lower mean symptom scores in the 6-14 days after initiation of therapy, compared with those who received 5 days of treatment (1.34 vs. 1.61; P = 0.07), while the number of children whose symptom scores decreased by 50% from baseline to the end of treatment was significantly lower in the 5-day group.
However, there were no significant differences between the two groups in the rate of nasopharyngeal colonization pathogens not susceptible to penicillin: 47% in the 10-day group, compared with 44% in the 5-day group (N Engl J Med. 2016 Dec 22;375[25]:2446-56).
Similarly, the rates of recurrence and adverse events were not significantly different between the two groups.
A shorter duration of treatment has been considered as a strategy for reducing the risk of antimicrobial resistance, but clinical trials so far have showed either modest difference favoring the standard duration of treatment, or no difference at all.
“The outcome differences we found were larger than the differences that have been reported previously, mainly because the rates of clinical failure among children who received reduced duration treatment were higher in our trial than in previous trials,” Dr. Hoberman and his associates wrote.
The researchers did note that clinical failure rates were higher among children with greater exposure to other children, and those with infection in both ears rather than a single ear.
The study was supported by the National Institute of Allergy and Infectious Diseases and the National Institutes of Health. Dr. Hoberman and Dr. Judith M. Martin declared consulting fees from Genocea Biosciences, and Dr. Hoberman declared grant support from Ricoh Innovations and holding pending patents for a reduced clavulanate concentration version of amoxicillin–clavulanate potassium, and a method and device for aiding in the diagnosis of otitis media. No other conflicts of interest were declared.
A shorter duration of antimicrobial therapy for acute otitis media (AOM) in children is associated with higher rates of clinical failure and higher symptom scores but without any associated reduction in the rates of antimicrobial resistance or adverse events.
Alejandro Hoberman, MD, of the Children’s Hospital of Pittsburgh at the University of Pittsburgh Medical Center, and his coauthors report the results of a study in which 520 children aged 6-23 months were randomized to either 10 days of amoxicillin-clavulanate therapy, or 5 days of therapy followed by 5 days of placebo.
The children who received the full 10-day course also had lower mean symptom scores in the 6-14 days after initiation of therapy, compared with those who received 5 days of treatment (1.34 vs. 1.61; P = 0.07), while the number of children whose symptom scores decreased by 50% from baseline to the end of treatment was significantly lower in the 5-day group.
However, there were no significant differences between the two groups in the rate of nasopharyngeal colonization pathogens not susceptible to penicillin: 47% in the 10-day group, compared with 44% in the 5-day group (N Engl J Med. 2016 Dec 22;375[25]:2446-56).
Similarly, the rates of recurrence and adverse events were not significantly different between the two groups.
A shorter duration of treatment has been considered as a strategy for reducing the risk of antimicrobial resistance, but clinical trials so far have showed either modest difference favoring the standard duration of treatment, or no difference at all.
“The outcome differences we found were larger than the differences that have been reported previously, mainly because the rates of clinical failure among children who received reduced duration treatment were higher in our trial than in previous trials,” Dr. Hoberman and his associates wrote.
The researchers did note that clinical failure rates were higher among children with greater exposure to other children, and those with infection in both ears rather than a single ear.
The study was supported by the National Institute of Allergy and Infectious Diseases and the National Institutes of Health. Dr. Hoberman and Dr. Judith M. Martin declared consulting fees from Genocea Biosciences, and Dr. Hoberman declared grant support from Ricoh Innovations and holding pending patents for a reduced clavulanate concentration version of amoxicillin–clavulanate potassium, and a method and device for aiding in the diagnosis of otitis media. No other conflicts of interest were declared.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: A shorter duration of antimicrobial therapy for acute otitis media (AOM) in children is associated with higher rates of clinical failure without a reduction in the rates of antimicrobial resistance.
Major finding: Children who received 5 days of antimicrobial experienced clinical failure rates of 35%, compared with 16% in those who received a full 10-day course.
Data source: Randomized controlled trial in 520 children aged 6-23 months with AOM.
Disclosures: The study was supported by the National Institute of Allergy and Infectious Diseases and the National Institutes of Health. Dr. Hoberman and Dr. Judith M. Martin declared consulting fees from Genocea Biosciences, and Dr. Hoberman declared grant support from Ricoh Innovations and holding pending patents for a reduced clavulanate concentration version of amoxicillin–clavulanate potassium, and a method and device for aiding in the diagnosis of otitis media. No other conflicts of interest were declared.
Coronary revascularization appropriate use criteria updated
For ST segment–elevation myocardial infarction (STEMI) patients presenting between 12 and 24 hours from symptom onset but with no signs of clinical instability, coronary revascularization “may be appropriate,” according to a new report. At the same time, for STEMI patients initially treated with fibrinolysis, revascularization was rated as “appropriate therapy” in the setting of suspected failed fibrinolytic therapy or in stable and asymptomatic patients from 3 to 24 hours after fibrinolysis.
Those are two conclusions contained in a revision of the appropriate use criteria (AUC) for coronary revascularization published on Dec. 21 (J Am Coll Cardiol. doi: 10.1016/j.jacc.2016.10.034).
“This update provides a reassessment of clinical scenarios that the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria,” Manesh R. Patel, MD, chief of the division of cardiology and codirector of the Duke Heart Center at Duke University, Durham, N.C., and chair of the seven-member writing committee for the document, said in a prepared statement. “The primary objective of the appropriate use criteria is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making and ultimately lead to better patient outcomes.”
The 22-page document contains 17 clinical scenarios that were scored by a separate committee of 17 experts to indicate whether revascularization in patients with acute coronary syndromes is appropriate, may be appropriate, or is rarely appropriate for the clinical scenario presented. Step-by-step flow charts are included to help use the criteria. “Since publication of the 2012 AUC document (J Am Coll Cardiol. 2012;59:857-81), new guidelines for [STEMI] and non–ST segment elevation myocardial infarction (NSTEMI)/unstable angina have been published with additional focused updates of the [stable ischemic heart disease] guideline and a combined focused update of the percutaneous coronary intervention (PCI) and STEMI guideline,” the writing committee noted. “New clinical trials have been published extending the knowledge and evidence around coronary revascularization, including trials that challenge earlier recommendations about the timing of nonculprit vessel PCI in the setting of STEMI. Additional studies related to coronary artery bypass graft surgery, medical therapy, and diagnostic technologies such as fractional flow reserve (FFR) have emerged as well as analyses from the National Cardiovascular Data Registry (NCDR) on the existing AUC that provide insights into practice patterns, clinical scenarios, and patient features not previously addressed.”
Conclusions in the document include those for nonculprit artery revascularization during the index hospitalization after primary PCI or fibrinolysis. This was rated as “appropriate and reasonable” for patients with one or more severe stenoses and spontaneous or easily provoked ischemia or for asymptomatic patients with ischemic findings on noninvasive testing. Meanwhile, in the presence of an intermediate-severity nonculprit artery stenosis, revascularization was rated as “appropriate therapy” in cases where the fractional flow reserve is at or below 0.80. For patients who are stable and asymptomatic after primary PCI, revascularization was rated as “may be appropriate” for one or more severe stenoses even in the absence of further testing.
The only “rarely appropriate” rating in patients with acute coronary syndromes occurred for asymptomatic patients with intermediate-severity nonculprit artery stenoses in the absence of any additional testing to demonstrate the functional significance of the stenosis.
“As in prior versions of the AUC, these revascularization ratings should be used to reinforce existing management strategies and identify patient populations that need more information to identify the most effective treatments,” the authors concluded. Dr. Patel reported having no financial disclosures.
For ST segment–elevation myocardial infarction (STEMI) patients presenting between 12 and 24 hours from symptom onset but with no signs of clinical instability, coronary revascularization “may be appropriate,” according to a new report. At the same time, for STEMI patients initially treated with fibrinolysis, revascularization was rated as “appropriate therapy” in the setting of suspected failed fibrinolytic therapy or in stable and asymptomatic patients from 3 to 24 hours after fibrinolysis.
Those are two conclusions contained in a revision of the appropriate use criteria (AUC) for coronary revascularization published on Dec. 21 (J Am Coll Cardiol. doi: 10.1016/j.jacc.2016.10.034).
“This update provides a reassessment of clinical scenarios that the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria,” Manesh R. Patel, MD, chief of the division of cardiology and codirector of the Duke Heart Center at Duke University, Durham, N.C., and chair of the seven-member writing committee for the document, said in a prepared statement. “The primary objective of the appropriate use criteria is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making and ultimately lead to better patient outcomes.”
The 22-page document contains 17 clinical scenarios that were scored by a separate committee of 17 experts to indicate whether revascularization in patients with acute coronary syndromes is appropriate, may be appropriate, or is rarely appropriate for the clinical scenario presented. Step-by-step flow charts are included to help use the criteria. “Since publication of the 2012 AUC document (J Am Coll Cardiol. 2012;59:857-81), new guidelines for [STEMI] and non–ST segment elevation myocardial infarction (NSTEMI)/unstable angina have been published with additional focused updates of the [stable ischemic heart disease] guideline and a combined focused update of the percutaneous coronary intervention (PCI) and STEMI guideline,” the writing committee noted. “New clinical trials have been published extending the knowledge and evidence around coronary revascularization, including trials that challenge earlier recommendations about the timing of nonculprit vessel PCI in the setting of STEMI. Additional studies related to coronary artery bypass graft surgery, medical therapy, and diagnostic technologies such as fractional flow reserve (FFR) have emerged as well as analyses from the National Cardiovascular Data Registry (NCDR) on the existing AUC that provide insights into practice patterns, clinical scenarios, and patient features not previously addressed.”
Conclusions in the document include those for nonculprit artery revascularization during the index hospitalization after primary PCI or fibrinolysis. This was rated as “appropriate and reasonable” for patients with one or more severe stenoses and spontaneous or easily provoked ischemia or for asymptomatic patients with ischemic findings on noninvasive testing. Meanwhile, in the presence of an intermediate-severity nonculprit artery stenosis, revascularization was rated as “appropriate therapy” in cases where the fractional flow reserve is at or below 0.80. For patients who are stable and asymptomatic after primary PCI, revascularization was rated as “may be appropriate” for one or more severe stenoses even in the absence of further testing.
The only “rarely appropriate” rating in patients with acute coronary syndromes occurred for asymptomatic patients with intermediate-severity nonculprit artery stenoses in the absence of any additional testing to demonstrate the functional significance of the stenosis.
“As in prior versions of the AUC, these revascularization ratings should be used to reinforce existing management strategies and identify patient populations that need more information to identify the most effective treatments,” the authors concluded. Dr. Patel reported having no financial disclosures.
For ST segment–elevation myocardial infarction (STEMI) patients presenting between 12 and 24 hours from symptom onset but with no signs of clinical instability, coronary revascularization “may be appropriate,” according to a new report. At the same time, for STEMI patients initially treated with fibrinolysis, revascularization was rated as “appropriate therapy” in the setting of suspected failed fibrinolytic therapy or in stable and asymptomatic patients from 3 to 24 hours after fibrinolysis.
Those are two conclusions contained in a revision of the appropriate use criteria (AUC) for coronary revascularization published on Dec. 21 (J Am Coll Cardiol. doi: 10.1016/j.jacc.2016.10.034).
“This update provides a reassessment of clinical scenarios that the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria,” Manesh R. Patel, MD, chief of the division of cardiology and codirector of the Duke Heart Center at Duke University, Durham, N.C., and chair of the seven-member writing committee for the document, said in a prepared statement. “The primary objective of the appropriate use criteria is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making and ultimately lead to better patient outcomes.”
The 22-page document contains 17 clinical scenarios that were scored by a separate committee of 17 experts to indicate whether revascularization in patients with acute coronary syndromes is appropriate, may be appropriate, or is rarely appropriate for the clinical scenario presented. Step-by-step flow charts are included to help use the criteria. “Since publication of the 2012 AUC document (J Am Coll Cardiol. 2012;59:857-81), new guidelines for [STEMI] and non–ST segment elevation myocardial infarction (NSTEMI)/unstable angina have been published with additional focused updates of the [stable ischemic heart disease] guideline and a combined focused update of the percutaneous coronary intervention (PCI) and STEMI guideline,” the writing committee noted. “New clinical trials have been published extending the knowledge and evidence around coronary revascularization, including trials that challenge earlier recommendations about the timing of nonculprit vessel PCI in the setting of STEMI. Additional studies related to coronary artery bypass graft surgery, medical therapy, and diagnostic technologies such as fractional flow reserve (FFR) have emerged as well as analyses from the National Cardiovascular Data Registry (NCDR) on the existing AUC that provide insights into practice patterns, clinical scenarios, and patient features not previously addressed.”
Conclusions in the document include those for nonculprit artery revascularization during the index hospitalization after primary PCI or fibrinolysis. This was rated as “appropriate and reasonable” for patients with one or more severe stenoses and spontaneous or easily provoked ischemia or for asymptomatic patients with ischemic findings on noninvasive testing. Meanwhile, in the presence of an intermediate-severity nonculprit artery stenosis, revascularization was rated as “appropriate therapy” in cases where the fractional flow reserve is at or below 0.80. For patients who are stable and asymptomatic after primary PCI, revascularization was rated as “may be appropriate” for one or more severe stenoses even in the absence of further testing.
The only “rarely appropriate” rating in patients with acute coronary syndromes occurred for asymptomatic patients with intermediate-severity nonculprit artery stenoses in the absence of any additional testing to demonstrate the functional significance of the stenosis.
“As in prior versions of the AUC, these revascularization ratings should be used to reinforce existing management strategies and identify patient populations that need more information to identify the most effective treatments,” the authors concluded. Dr. Patel reported having no financial disclosures.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Initial suboptimal responders to secukinumab usually bloom later
VIENNA – When the occasional patient on secukinumab for moderate to severe psoriasis fails to achieve a PASI 75 response initially, don’t despair: Continuing treatment with the biologic usually gets them over that bar, Christopher E. Griffiths, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
A new secondary pooled analysis of four phase III, 52-week, pivotal clinical trials of secukinumab (Cosentyx) indicates that more than three-quarters of initial suboptimal responders will go on to achieve a PASI 75 response. Moreover, more than one-third will have a PASI 90 response by week 16, which is sustained through week 52. And almost one in five slow responders will have a PASI 100 response – clear skin – at week 52, according to Dr. Griffiths, professor of dermatology at the University of Manchester, England.
He presented a secondary analysis of four phase III studies: ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis), FEATURE (First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks), FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), and JUNCTURE (Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results). The analysis was conducted to provide additional perspective on the product labeling statement that treatment discontinuation should be considered in patients who haven’t responded to secukinumab by week 16.
The four studies featured a total of 2,405 patients with moderate to severe psoriasis on secukinumab at the approved dosing schedule.
The key findings: At week 12 – the primary endpoint in the four trials – only 5.2% of patients on secukinumab had not achieved a PASI 75 response. Yet just 4 weeks later, at week 16, 56% of this group had managed to get there. Seventy-seven percent of early non- or partial responders achieved a PASI 75 response at some point during weeks 13-52, and 55% had a PASI 75 response at 52 weeks.
Thirty-five percent of early poor responders achieved PASI 90 at 16 weeks and 37% at 52 weeks. Twelve percent of patients who didn’t get to PASI 75 at 12 weeks had a PASI 100 response by 16 weeks, and nearly 18% did by week 52.
This analysis was supported by secukinumab manufacturer Novartis. Dr. Griffiths reported receiving research funds from and serving as a consultant to Novartis and numerous other pharmaceutical companies.
VIENNA – When the occasional patient on secukinumab for moderate to severe psoriasis fails to achieve a PASI 75 response initially, don’t despair: Continuing treatment with the biologic usually gets them over that bar, Christopher E. Griffiths, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
A new secondary pooled analysis of four phase III, 52-week, pivotal clinical trials of secukinumab (Cosentyx) indicates that more than three-quarters of initial suboptimal responders will go on to achieve a PASI 75 response. Moreover, more than one-third will have a PASI 90 response by week 16, which is sustained through week 52. And almost one in five slow responders will have a PASI 100 response – clear skin – at week 52, according to Dr. Griffiths, professor of dermatology at the University of Manchester, England.
He presented a secondary analysis of four phase III studies: ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis), FEATURE (First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks), FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), and JUNCTURE (Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results). The analysis was conducted to provide additional perspective on the product labeling statement that treatment discontinuation should be considered in patients who haven’t responded to secukinumab by week 16.
The four studies featured a total of 2,405 patients with moderate to severe psoriasis on secukinumab at the approved dosing schedule.
The key findings: At week 12 – the primary endpoint in the four trials – only 5.2% of patients on secukinumab had not achieved a PASI 75 response. Yet just 4 weeks later, at week 16, 56% of this group had managed to get there. Seventy-seven percent of early non- or partial responders achieved a PASI 75 response at some point during weeks 13-52, and 55% had a PASI 75 response at 52 weeks.
Thirty-five percent of early poor responders achieved PASI 90 at 16 weeks and 37% at 52 weeks. Twelve percent of patients who didn’t get to PASI 75 at 12 weeks had a PASI 100 response by 16 weeks, and nearly 18% did by week 52.
This analysis was supported by secukinumab manufacturer Novartis. Dr. Griffiths reported receiving research funds from and serving as a consultant to Novartis and numerous other pharmaceutical companies.
VIENNA – When the occasional patient on secukinumab for moderate to severe psoriasis fails to achieve a PASI 75 response initially, don’t despair: Continuing treatment with the biologic usually gets them over that bar, Christopher E. Griffiths, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
A new secondary pooled analysis of four phase III, 52-week, pivotal clinical trials of secukinumab (Cosentyx) indicates that more than three-quarters of initial suboptimal responders will go on to achieve a PASI 75 response. Moreover, more than one-third will have a PASI 90 response by week 16, which is sustained through week 52. And almost one in five slow responders will have a PASI 100 response – clear skin – at week 52, according to Dr. Griffiths, professor of dermatology at the University of Manchester, England.
He presented a secondary analysis of four phase III studies: ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis), FEATURE (First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks), FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), and JUNCTURE (Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results). The analysis was conducted to provide additional perspective on the product labeling statement that treatment discontinuation should be considered in patients who haven’t responded to secukinumab by week 16.
The four studies featured a total of 2,405 patients with moderate to severe psoriasis on secukinumab at the approved dosing schedule.
The key findings: At week 12 – the primary endpoint in the four trials – only 5.2% of patients on secukinumab had not achieved a PASI 75 response. Yet just 4 weeks later, at week 16, 56% of this group had managed to get there. Seventy-seven percent of early non- or partial responders achieved a PASI 75 response at some point during weeks 13-52, and 55% had a PASI 75 response at 52 weeks.
Thirty-five percent of early poor responders achieved PASI 90 at 16 weeks and 37% at 52 weeks. Twelve percent of patients who didn’t get to PASI 75 at 12 weeks had a PASI 100 response by 16 weeks, and nearly 18% did by week 52.
This analysis was supported by secukinumab manufacturer Novartis. Dr. Griffiths reported receiving research funds from and serving as a consultant to Novartis and numerous other pharmaceutical companies.
AT THE EADV CONGRESS
Key clinical point:
Major finding: Most psoriasis patients who don’t achieve a PASI 75 response by week 12 on secukinumab will do so by week 16 and will maintain that response through week 52.
Data source: A pooled secondary analysis of PASI response rates in four phase III randomized clinical trials of secukinumab featuring 2,405 patients with moderate to severe psoriasis who were on the biologic for 52 weeks, including the 119 who did not achieve a PASI 75 response by week 12.
Disclosures: This analysis of four phase III clinical trials was sponsored by Novartis, as were the trials. The presenter reported receiving research funding from and serving as a consultant to Novartis and other pharmaceutical companies.
Systemic inflammation expands clinical challenge in IBD
ORLANDO – Prescribing optimal therapy for a patient with inflammatory bowel disease can be challenging under ordinary circumstances, but add an extra-intestinal manifestation and the complexity grows greater still. Until more evidence-based findings emerge to help guide and individualize systemic or combination therapy, one of the advantages of biologics – their ability to target the intestine – can be a drawback when patients present with other manifestations.
To highlight the challenges and propose management strategies, Corey A. Siegel, MD, presented the case of a 45-year-old man seeking care 8 years after a diagnosis of ileocolonic Crohn’s disease. Seven years earlier, after the patient failed 5-aminosalicylic acid medication and prednisone therapy, clinicians prescribed infliximab (Remicade, Janssen) monotherapy. He experienced a “great response,” Dr. Siegel said at the Advances in Inflammatory Bowel Diseases meeting.
“Unfortunately, he had a real-life delayed hypersensitivity reaction 2 years ago with no drug present at trough and good antibodies, equal to 12 on a drug tolerant assay,” added Dr. Siegel, director of the Inflammatory Bowel Disease Center at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and moderator of a case discussion panel session. So physicians initiated combination therapy with adalimumab (Humira, AbbVie) and methotrexate, but the patient “never felt as good as he did on infliximab, even with weekly dosing.”
A colonoscopy 9 months ago revealed mild to mildly active ileal and ascending colon disease. “So he still has residual disease present, even with weekly dosing of adalimumab,” Dr. Siegel explained. At the time, clinicians prescribed vedolizumab (Entyvio, Takeda) and the patient reported IBD symptom improvement. “He was doing better but not fantastic, and now his joints were bothering him, and they never bothered him before.” The man reported joint pain in his hands, knees, and hips. A more recent, follow-up colonoscopy revealed improvement, although mildly active disease was still present.
Do we need to dose-optimize vedolizumab or is it time to move on here? Dr. Siegel asked an expert panel: Bruce E. Sands, MD, David T. Rubin, MD, and Gary L. Lichtenstein, MD.
Instead of considering a third anti–tumor necrosis factor (anti-TNF) agent when the patient has already not responded fully to others in that class, Dr. Sands suggested ustekinumab (Stelara, Janssen). “It could be that ustekinumab would be a better choice versus dose escalation of vedolizumab, unless you add something to the dose-escalated vedolizumab to treat the arthralgias like celecoxib.”
Next, Dr. Siegel asked if the arthralgias are truly extra-intestinal manifestations of inflammatory bowel disease “or is it what my patients are telling me – what they see all over the Internet – that vedolizumab causes arthralgias or arthropathies?
“That is an important question,” said Dr. Rubin, section chief of gastroenterology, hepatology, and nutrition at the University of Chicago. “My question back to you is when did the joint pain start – right after vedolizumab was initiated? Right after steroids were tapered? Or after the patient was on stable dosing for some time?”
The arthralgias seemed to start right after the patient started vedolizumab, Dr. Siegel said. But when clinicians inquired a little further, the patient reported “it was when he came off the adalimumab that things really started.”
It could be that systemically active infliximab and adalimumab with methotrexate were essentially covering up an extra-intestinal manifestation that was later uncovered with the selective mechanism of vedolizumab, Dr. Rubin said. “If that’s true, I don’t think I would give him more vedolizumab to treat his joint pain – that certainly wouldn’t do it. I would make sure his disease is responding from mucosal view, then I would add methotrexate or even consider sulfasalazine.”
A meeting attendee said that the patient did very well with infliximab, and asked “can we ever go back?”
“Probably not easily,” Dr. Sands said. “For someone with a bona fide delayed hypersensitivity reaction – I wouldn’t go there, and I wouldn’t think that you could.”
Another attendee asked if there is a role for adding another biologic to vedolizumab. “We hope to initiate a study soon looking at combination of biologics, such as vedolizumab with adalimumab, with and without an immunomodulator, Dr. Sands replied. They cover somewhat different targets – so it’s sort of a ‘belts and suspenders approach’ … but there are no data whatsoever [yet].”
Dr. Siegel wrapped up the case discussion with the patient’s outcomes. “We did move him on to ustekinumab. He felt better and his arthralgias went away.”
The meeting was sponsored by the Crohn’s & Colitis Foundation of America.
Dr. Siegel and Dr. Rubin disclosed ties with AbbVie, Janssen, and Takeda. Dr. Sands disclosed ties with AbbVie, Janssen Biotech, and Takeda. Dr. Lichtenstein disclosed ties with AbbVie, Janssen Orthobiotech, and Takeda.
ORLANDO – Prescribing optimal therapy for a patient with inflammatory bowel disease can be challenging under ordinary circumstances, but add an extra-intestinal manifestation and the complexity grows greater still. Until more evidence-based findings emerge to help guide and individualize systemic or combination therapy, one of the advantages of biologics – their ability to target the intestine – can be a drawback when patients present with other manifestations.
To highlight the challenges and propose management strategies, Corey A. Siegel, MD, presented the case of a 45-year-old man seeking care 8 years after a diagnosis of ileocolonic Crohn’s disease. Seven years earlier, after the patient failed 5-aminosalicylic acid medication and prednisone therapy, clinicians prescribed infliximab (Remicade, Janssen) monotherapy. He experienced a “great response,” Dr. Siegel said at the Advances in Inflammatory Bowel Diseases meeting.
“Unfortunately, he had a real-life delayed hypersensitivity reaction 2 years ago with no drug present at trough and good antibodies, equal to 12 on a drug tolerant assay,” added Dr. Siegel, director of the Inflammatory Bowel Disease Center at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and moderator of a case discussion panel session. So physicians initiated combination therapy with adalimumab (Humira, AbbVie) and methotrexate, but the patient “never felt as good as he did on infliximab, even with weekly dosing.”
A colonoscopy 9 months ago revealed mild to mildly active ileal and ascending colon disease. “So he still has residual disease present, even with weekly dosing of adalimumab,” Dr. Siegel explained. At the time, clinicians prescribed vedolizumab (Entyvio, Takeda) and the patient reported IBD symptom improvement. “He was doing better but not fantastic, and now his joints were bothering him, and they never bothered him before.” The man reported joint pain in his hands, knees, and hips. A more recent, follow-up colonoscopy revealed improvement, although mildly active disease was still present.
Do we need to dose-optimize vedolizumab or is it time to move on here? Dr. Siegel asked an expert panel: Bruce E. Sands, MD, David T. Rubin, MD, and Gary L. Lichtenstein, MD.
Instead of considering a third anti–tumor necrosis factor (anti-TNF) agent when the patient has already not responded fully to others in that class, Dr. Sands suggested ustekinumab (Stelara, Janssen). “It could be that ustekinumab would be a better choice versus dose escalation of vedolizumab, unless you add something to the dose-escalated vedolizumab to treat the arthralgias like celecoxib.”
Next, Dr. Siegel asked if the arthralgias are truly extra-intestinal manifestations of inflammatory bowel disease “or is it what my patients are telling me – what they see all over the Internet – that vedolizumab causes arthralgias or arthropathies?
“That is an important question,” said Dr. Rubin, section chief of gastroenterology, hepatology, and nutrition at the University of Chicago. “My question back to you is when did the joint pain start – right after vedolizumab was initiated? Right after steroids were tapered? Or after the patient was on stable dosing for some time?”
The arthralgias seemed to start right after the patient started vedolizumab, Dr. Siegel said. But when clinicians inquired a little further, the patient reported “it was when he came off the adalimumab that things really started.”
It could be that systemically active infliximab and adalimumab with methotrexate were essentially covering up an extra-intestinal manifestation that was later uncovered with the selective mechanism of vedolizumab, Dr. Rubin said. “If that’s true, I don’t think I would give him more vedolizumab to treat his joint pain – that certainly wouldn’t do it. I would make sure his disease is responding from mucosal view, then I would add methotrexate or even consider sulfasalazine.”
A meeting attendee said that the patient did very well with infliximab, and asked “can we ever go back?”
“Probably not easily,” Dr. Sands said. “For someone with a bona fide delayed hypersensitivity reaction – I wouldn’t go there, and I wouldn’t think that you could.”
Another attendee asked if there is a role for adding another biologic to vedolizumab. “We hope to initiate a study soon looking at combination of biologics, such as vedolizumab with adalimumab, with and without an immunomodulator, Dr. Sands replied. They cover somewhat different targets – so it’s sort of a ‘belts and suspenders approach’ … but there are no data whatsoever [yet].”
Dr. Siegel wrapped up the case discussion with the patient’s outcomes. “We did move him on to ustekinumab. He felt better and his arthralgias went away.”
The meeting was sponsored by the Crohn’s & Colitis Foundation of America.
Dr. Siegel and Dr. Rubin disclosed ties with AbbVie, Janssen, and Takeda. Dr. Sands disclosed ties with AbbVie, Janssen Biotech, and Takeda. Dr. Lichtenstein disclosed ties with AbbVie, Janssen Orthobiotech, and Takeda.
ORLANDO – Prescribing optimal therapy for a patient with inflammatory bowel disease can be challenging under ordinary circumstances, but add an extra-intestinal manifestation and the complexity grows greater still. Until more evidence-based findings emerge to help guide and individualize systemic or combination therapy, one of the advantages of biologics – their ability to target the intestine – can be a drawback when patients present with other manifestations.
To highlight the challenges and propose management strategies, Corey A. Siegel, MD, presented the case of a 45-year-old man seeking care 8 years after a diagnosis of ileocolonic Crohn’s disease. Seven years earlier, after the patient failed 5-aminosalicylic acid medication and prednisone therapy, clinicians prescribed infliximab (Remicade, Janssen) monotherapy. He experienced a “great response,” Dr. Siegel said at the Advances in Inflammatory Bowel Diseases meeting.
“Unfortunately, he had a real-life delayed hypersensitivity reaction 2 years ago with no drug present at trough and good antibodies, equal to 12 on a drug tolerant assay,” added Dr. Siegel, director of the Inflammatory Bowel Disease Center at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and moderator of a case discussion panel session. So physicians initiated combination therapy with adalimumab (Humira, AbbVie) and methotrexate, but the patient “never felt as good as he did on infliximab, even with weekly dosing.”
A colonoscopy 9 months ago revealed mild to mildly active ileal and ascending colon disease. “So he still has residual disease present, even with weekly dosing of adalimumab,” Dr. Siegel explained. At the time, clinicians prescribed vedolizumab (Entyvio, Takeda) and the patient reported IBD symptom improvement. “He was doing better but not fantastic, and now his joints were bothering him, and they never bothered him before.” The man reported joint pain in his hands, knees, and hips. A more recent, follow-up colonoscopy revealed improvement, although mildly active disease was still present.
Do we need to dose-optimize vedolizumab or is it time to move on here? Dr. Siegel asked an expert panel: Bruce E. Sands, MD, David T. Rubin, MD, and Gary L. Lichtenstein, MD.
Instead of considering a third anti–tumor necrosis factor (anti-TNF) agent when the patient has already not responded fully to others in that class, Dr. Sands suggested ustekinumab (Stelara, Janssen). “It could be that ustekinumab would be a better choice versus dose escalation of vedolizumab, unless you add something to the dose-escalated vedolizumab to treat the arthralgias like celecoxib.”
Next, Dr. Siegel asked if the arthralgias are truly extra-intestinal manifestations of inflammatory bowel disease “or is it what my patients are telling me – what they see all over the Internet – that vedolizumab causes arthralgias or arthropathies?
“That is an important question,” said Dr. Rubin, section chief of gastroenterology, hepatology, and nutrition at the University of Chicago. “My question back to you is when did the joint pain start – right after vedolizumab was initiated? Right after steroids were tapered? Or after the patient was on stable dosing for some time?”
The arthralgias seemed to start right after the patient started vedolizumab, Dr. Siegel said. But when clinicians inquired a little further, the patient reported “it was when he came off the adalimumab that things really started.”
It could be that systemically active infliximab and adalimumab with methotrexate were essentially covering up an extra-intestinal manifestation that was later uncovered with the selective mechanism of vedolizumab, Dr. Rubin said. “If that’s true, I don’t think I would give him more vedolizumab to treat his joint pain – that certainly wouldn’t do it. I would make sure his disease is responding from mucosal view, then I would add methotrexate or even consider sulfasalazine.”
A meeting attendee said that the patient did very well with infliximab, and asked “can we ever go back?”
“Probably not easily,” Dr. Sands said. “For someone with a bona fide delayed hypersensitivity reaction – I wouldn’t go there, and I wouldn’t think that you could.”
Another attendee asked if there is a role for adding another biologic to vedolizumab. “We hope to initiate a study soon looking at combination of biologics, such as vedolizumab with adalimumab, with and without an immunomodulator, Dr. Sands replied. They cover somewhat different targets – so it’s sort of a ‘belts and suspenders approach’ … but there are no data whatsoever [yet].”
Dr. Siegel wrapped up the case discussion with the patient’s outcomes. “We did move him on to ustekinumab. He felt better and his arthralgias went away.”
The meeting was sponsored by the Crohn’s & Colitis Foundation of America.
Dr. Siegel and Dr. Rubin disclosed ties with AbbVie, Janssen, and Takeda. Dr. Sands disclosed ties with AbbVie, Janssen Biotech, and Takeda. Dr. Lichtenstein disclosed ties with AbbVie, Janssen Orthobiotech, and Takeda.
AT AIBD 2016
Key clinical point: Extra-intestinal manifestations of inflammatory bowel disease can leave gastroenterologists wondering about the best approach to treatment.
Major finding: Less gut-specific drug action may actually be better for these patients.
Data source: Panel discussion of challenging cases at AIBD 2016.
Disclosures: Dr. Siegel and Dr. Rubin disclosed ties with AbbVie, Janssen, and Takeda. Dr. Sands disclosed ties with AbbVie, Janssen Biotech, and Takeda. Dr. Lichtenstein disclosed ties with AbbVie, Janssen Orthobiotech, and Takeda.
Stress management for ambitious students
Most parents hope that their children will be motivated and hard-working at school, but ambitious students usually face very high levels of stress. Ambitious young people typically push themselves very hard and may not spend enough time in play, relaxation, or exploring potential interests. Their time with peers might be more competitive than social or fun. They may become rigidly focused on a goal, paving the way for devastation if they fall short of their own expectations. They may internalize stress and not ask for help if it starts to take a toll on their mental health. But ambition is not incompatible with healthy development and well-being. Pediatricians usually know who the ambitious students in their practice are, and will hear about the stress they may be experiencing. You have the opportunity to offer them (or their parents) some strategies to manage their high stress levels, and build resilience.
Support ambition, but not perfectionism
It can be helpful to acknowledge to young people that they are ambitious, enabling them to acknowledge this fact about themselves. This kind of drive can be an admirable strength when it is part of an emerging identity, a wish to be successful as defined by the patient.
It is more likely to be problematic if it is a product of a parent’s need to have a child perform as they deem best. Second, it is critical to differentiate ambition from perfectionism. While ambition can keep someone focused and motivated in the face of difficulty, perfectionism is a bully that leaves a person feeling perpetually inadequate. Ambition without a specific interest or focus can lead to general perfectionism in a young person, and parents might unwittingly support this by applauding successes or becoming overinvested in this success reflecting onto them. When the pediatrician points out to a patient (and parents) that perfection is neither possible nor desirable, they may respond, “why wouldn’t I want to be perfect?” Remind them that perfectionism is actually the enemy of long-term accomplishment, discouraging risk-taking, reflection, and growth.
Celebrate failure!
The critical difference between an ambitious person who is persistent and determined (and thus equipped to succeed) and the brittle perfectionist is the ability to tolerate failure and setbacks. Point out to your patients that ambition means there will be a lot of setbacks, disappointments, and failures, as they attempt things that are challenging. Indeed, they should embrace each little failure, as that is how real learning and growth happen, especially if they are constantly stretching their goals.
As children or teenagers learn that failure is evidence that they are on track, working hard, and improving, they will develop tenacity and flexibility. Carol S. Dweck, PhD, a psychologist who has studied school performance in young people, has demonstrated that when young people are praised for their results they tend to give up when they fail, whereas if they are praised for their hard work and persistence, they redouble their effort when they fail. Parents, teachers, and pediatricians have the power to shift an ambitious child’s mindset (Dweck’s term) by helping the child change his or her thinking about what failure really means.
Cultivate self-awareness and perspective
It is one of the central tasks of growing up to learn what one’s interests, talents, and values are, and this self-knowledge is especially critical in ambitious young people. Without genuine interests or passions, ambition may feel like a hollow quest for approval. It is more likely to become general perfectionism. So children and teenagers need adults who are curious about their underlying interests, who patiently help them to cultivate these interests and dedicate their ambition to the pursuit of these passions. Younger children need adult time and support to explore a variety of interests, dabbling so they might figure out where their interests and talents converge. This can provide plenty of opportunity to celebrate effort over achievement. By adolescence, they should have a clearer sense of their personal interests and abilities, and will be deepening their efforts in fewer areas. Adolescence is also when they start to build a narrative of who they are and what values are truly their own. Parents can serve as models and facilitators for their teenagers’ emerging sets of values. Values such as honesty, compassion, or generosity (for example) organize one’s efforts, giving them deeper meaning and keeping difficulties in perspective. Values also will help ambitious young people set their own goals and create an individualized and meaningful definition of success, and keep bigger failures, losses, or disappointments in perspective.
Teach self-care
It seems obvious to state that learning how to care for one’s self is essential to well-being, but for ambitious young people (and adults), self-care is often the first thing to go (or the last thing they consider) in their busy days. Explain to your patients (and parents) that without adequate, consistent, restful sleep, all of their hard work will be inefficient or likely squandered. Explain that daily cardiovascular exercise is not frivolous, but rather essential to balance their cognitive efforts, and offers potent protection for their physical and mental health. There is even robust evidence that sleep and exercise are directly helpful to memory, learning, and creativity. When a parent models this kind of self-care, it is far more powerful than simply talking about it!
Relaxation is self-care!
While most teenagers do not need to be taught how to relax, those very ambitious ones are likely to need permission and even help in learning how to effectively and efficiently blow off steam. Help them to approach relaxation as they would approach a new subject, open-minded and trying different things to determine what works for them. Some may find exercise relaxing, while some may need a cognitive distraction (sometimes called “senseless fun,” an activity not dedicated to achievement) such as reading, family games, or television. Social time often is very effective relaxation for teenagers, and they should know that it is as important as sleep and studying for their performance. Some may find that a calming activity such as yoga or meditation recharges their batteries, whereas others may need noisy video games to feel renewed. Suggest that they should protect (just a little) time for relaxation even on their busiest days to help them develop good habits of self-care. Without consistent, reliable relaxation, ambitious young people are at risk for burnout or for impulsive and extreme behaviors such as binge-drinking.
Be on the lookout for red flags
In the same way that high performing athletes are at risk for stress fractures or other injuries of repetitive, intense physical activity, ambitious students are vulnerable to some of the problems that can follow sustained, intense cognitive effort. These risks go up if they are sleep deprived, stop exercising, or are socially isolated. Parents can be on the lookout for signs of depression or anxiety disorders, such as loss of energy, withdrawal from friends or beloved activities, persistent unhappiness or irritability (sustained over days to weeks), and of course morbid preoccupations.
Intense perfectionism is common among young people at risk for eating disorders, depression and self-injury, and anxiety disorders. Beyond recognizing signs, it is even more important for parents and pediatricians to equip ambitious young people to stay connected and ask for help if they experience a change in their emotional equilibrium. Suggest to your patients that they should never worry alone. They should ask for help if they are struggling to sleep, to sustain their motivation or effort, or notice feeling panicked, unusually tearful, or hopeless. Depression and anxiety are common and treatable problems in adolescents, but ambitious adolescents might be inclined to try to soldier through them. Caring adults should demystify and destigmatize mood and anxiety problems. You might point out that they would ask for help for a toothache or a painful knee joint, and that their mental health should be no different.
Many ambitious children have ambitious parents who might look back on their own adolescence and wonder if they were sufficiently balanced in their approach or whether they overreacted to failure. Sometimes honest sharing of successes, failures, and enduring dilemmas can build an empathic bridge from one generation to the next.
Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
Most parents hope that their children will be motivated and hard-working at school, but ambitious students usually face very high levels of stress. Ambitious young people typically push themselves very hard and may not spend enough time in play, relaxation, or exploring potential interests. Their time with peers might be more competitive than social or fun. They may become rigidly focused on a goal, paving the way for devastation if they fall short of their own expectations. They may internalize stress and not ask for help if it starts to take a toll on their mental health. But ambition is not incompatible with healthy development and well-being. Pediatricians usually know who the ambitious students in their practice are, and will hear about the stress they may be experiencing. You have the opportunity to offer them (or their parents) some strategies to manage their high stress levels, and build resilience.
Support ambition, but not perfectionism
It can be helpful to acknowledge to young people that they are ambitious, enabling them to acknowledge this fact about themselves. This kind of drive can be an admirable strength when it is part of an emerging identity, a wish to be successful as defined by the patient.
It is more likely to be problematic if it is a product of a parent’s need to have a child perform as they deem best. Second, it is critical to differentiate ambition from perfectionism. While ambition can keep someone focused and motivated in the face of difficulty, perfectionism is a bully that leaves a person feeling perpetually inadequate. Ambition without a specific interest or focus can lead to general perfectionism in a young person, and parents might unwittingly support this by applauding successes or becoming overinvested in this success reflecting onto them. When the pediatrician points out to a patient (and parents) that perfection is neither possible nor desirable, they may respond, “why wouldn’t I want to be perfect?” Remind them that perfectionism is actually the enemy of long-term accomplishment, discouraging risk-taking, reflection, and growth.
Celebrate failure!
The critical difference between an ambitious person who is persistent and determined (and thus equipped to succeed) and the brittle perfectionist is the ability to tolerate failure and setbacks. Point out to your patients that ambition means there will be a lot of setbacks, disappointments, and failures, as they attempt things that are challenging. Indeed, they should embrace each little failure, as that is how real learning and growth happen, especially if they are constantly stretching their goals.
As children or teenagers learn that failure is evidence that they are on track, working hard, and improving, they will develop tenacity and flexibility. Carol S. Dweck, PhD, a psychologist who has studied school performance in young people, has demonstrated that when young people are praised for their results they tend to give up when they fail, whereas if they are praised for their hard work and persistence, they redouble their effort when they fail. Parents, teachers, and pediatricians have the power to shift an ambitious child’s mindset (Dweck’s term) by helping the child change his or her thinking about what failure really means.
Cultivate self-awareness and perspective
It is one of the central tasks of growing up to learn what one’s interests, talents, and values are, and this self-knowledge is especially critical in ambitious young people. Without genuine interests or passions, ambition may feel like a hollow quest for approval. It is more likely to become general perfectionism. So children and teenagers need adults who are curious about their underlying interests, who patiently help them to cultivate these interests and dedicate their ambition to the pursuit of these passions. Younger children need adult time and support to explore a variety of interests, dabbling so they might figure out where their interests and talents converge. This can provide plenty of opportunity to celebrate effort over achievement. By adolescence, they should have a clearer sense of their personal interests and abilities, and will be deepening their efforts in fewer areas. Adolescence is also when they start to build a narrative of who they are and what values are truly their own. Parents can serve as models and facilitators for their teenagers’ emerging sets of values. Values such as honesty, compassion, or generosity (for example) organize one’s efforts, giving them deeper meaning and keeping difficulties in perspective. Values also will help ambitious young people set their own goals and create an individualized and meaningful definition of success, and keep bigger failures, losses, or disappointments in perspective.
Teach self-care
It seems obvious to state that learning how to care for one’s self is essential to well-being, but for ambitious young people (and adults), self-care is often the first thing to go (or the last thing they consider) in their busy days. Explain to your patients (and parents) that without adequate, consistent, restful sleep, all of their hard work will be inefficient or likely squandered. Explain that daily cardiovascular exercise is not frivolous, but rather essential to balance their cognitive efforts, and offers potent protection for their physical and mental health. There is even robust evidence that sleep and exercise are directly helpful to memory, learning, and creativity. When a parent models this kind of self-care, it is far more powerful than simply talking about it!
Relaxation is self-care!
While most teenagers do not need to be taught how to relax, those very ambitious ones are likely to need permission and even help in learning how to effectively and efficiently blow off steam. Help them to approach relaxation as they would approach a new subject, open-minded and trying different things to determine what works for them. Some may find exercise relaxing, while some may need a cognitive distraction (sometimes called “senseless fun,” an activity not dedicated to achievement) such as reading, family games, or television. Social time often is very effective relaxation for teenagers, and they should know that it is as important as sleep and studying for their performance. Some may find that a calming activity such as yoga or meditation recharges their batteries, whereas others may need noisy video games to feel renewed. Suggest that they should protect (just a little) time for relaxation even on their busiest days to help them develop good habits of self-care. Without consistent, reliable relaxation, ambitious young people are at risk for burnout or for impulsive and extreme behaviors such as binge-drinking.
Be on the lookout for red flags
In the same way that high performing athletes are at risk for stress fractures or other injuries of repetitive, intense physical activity, ambitious students are vulnerable to some of the problems that can follow sustained, intense cognitive effort. These risks go up if they are sleep deprived, stop exercising, or are socially isolated. Parents can be on the lookout for signs of depression or anxiety disorders, such as loss of energy, withdrawal from friends or beloved activities, persistent unhappiness or irritability (sustained over days to weeks), and of course morbid preoccupations.
Intense perfectionism is common among young people at risk for eating disorders, depression and self-injury, and anxiety disorders. Beyond recognizing signs, it is even more important for parents and pediatricians to equip ambitious young people to stay connected and ask for help if they experience a change in their emotional equilibrium. Suggest to your patients that they should never worry alone. They should ask for help if they are struggling to sleep, to sustain their motivation or effort, or notice feeling panicked, unusually tearful, or hopeless. Depression and anxiety are common and treatable problems in adolescents, but ambitious adolescents might be inclined to try to soldier through them. Caring adults should demystify and destigmatize mood and anxiety problems. You might point out that they would ask for help for a toothache or a painful knee joint, and that their mental health should be no different.
Many ambitious children have ambitious parents who might look back on their own adolescence and wonder if they were sufficiently balanced in their approach or whether they overreacted to failure. Sometimes honest sharing of successes, failures, and enduring dilemmas can build an empathic bridge from one generation to the next.
Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
Most parents hope that their children will be motivated and hard-working at school, but ambitious students usually face very high levels of stress. Ambitious young people typically push themselves very hard and may not spend enough time in play, relaxation, or exploring potential interests. Their time with peers might be more competitive than social or fun. They may become rigidly focused on a goal, paving the way for devastation if they fall short of their own expectations. They may internalize stress and not ask for help if it starts to take a toll on their mental health. But ambition is not incompatible with healthy development and well-being. Pediatricians usually know who the ambitious students in their practice are, and will hear about the stress they may be experiencing. You have the opportunity to offer them (or their parents) some strategies to manage their high stress levels, and build resilience.
Support ambition, but not perfectionism
It can be helpful to acknowledge to young people that they are ambitious, enabling them to acknowledge this fact about themselves. This kind of drive can be an admirable strength when it is part of an emerging identity, a wish to be successful as defined by the patient.
It is more likely to be problematic if it is a product of a parent’s need to have a child perform as they deem best. Second, it is critical to differentiate ambition from perfectionism. While ambition can keep someone focused and motivated in the face of difficulty, perfectionism is a bully that leaves a person feeling perpetually inadequate. Ambition without a specific interest or focus can lead to general perfectionism in a young person, and parents might unwittingly support this by applauding successes or becoming overinvested in this success reflecting onto them. When the pediatrician points out to a patient (and parents) that perfection is neither possible nor desirable, they may respond, “why wouldn’t I want to be perfect?” Remind them that perfectionism is actually the enemy of long-term accomplishment, discouraging risk-taking, reflection, and growth.
Celebrate failure!
The critical difference between an ambitious person who is persistent and determined (and thus equipped to succeed) and the brittle perfectionist is the ability to tolerate failure and setbacks. Point out to your patients that ambition means there will be a lot of setbacks, disappointments, and failures, as they attempt things that are challenging. Indeed, they should embrace each little failure, as that is how real learning and growth happen, especially if they are constantly stretching their goals.
As children or teenagers learn that failure is evidence that they are on track, working hard, and improving, they will develop tenacity and flexibility. Carol S. Dweck, PhD, a psychologist who has studied school performance in young people, has demonstrated that when young people are praised for their results they tend to give up when they fail, whereas if they are praised for their hard work and persistence, they redouble their effort when they fail. Parents, teachers, and pediatricians have the power to shift an ambitious child’s mindset (Dweck’s term) by helping the child change his or her thinking about what failure really means.
Cultivate self-awareness and perspective
It is one of the central tasks of growing up to learn what one’s interests, talents, and values are, and this self-knowledge is especially critical in ambitious young people. Without genuine interests or passions, ambition may feel like a hollow quest for approval. It is more likely to become general perfectionism. So children and teenagers need adults who are curious about their underlying interests, who patiently help them to cultivate these interests and dedicate their ambition to the pursuit of these passions. Younger children need adult time and support to explore a variety of interests, dabbling so they might figure out where their interests and talents converge. This can provide plenty of opportunity to celebrate effort over achievement. By adolescence, they should have a clearer sense of their personal interests and abilities, and will be deepening their efforts in fewer areas. Adolescence is also when they start to build a narrative of who they are and what values are truly their own. Parents can serve as models and facilitators for their teenagers’ emerging sets of values. Values such as honesty, compassion, or generosity (for example) organize one’s efforts, giving them deeper meaning and keeping difficulties in perspective. Values also will help ambitious young people set their own goals and create an individualized and meaningful definition of success, and keep bigger failures, losses, or disappointments in perspective.
Teach self-care
It seems obvious to state that learning how to care for one’s self is essential to well-being, but for ambitious young people (and adults), self-care is often the first thing to go (or the last thing they consider) in their busy days. Explain to your patients (and parents) that without adequate, consistent, restful sleep, all of their hard work will be inefficient or likely squandered. Explain that daily cardiovascular exercise is not frivolous, but rather essential to balance their cognitive efforts, and offers potent protection for their physical and mental health. There is even robust evidence that sleep and exercise are directly helpful to memory, learning, and creativity. When a parent models this kind of self-care, it is far more powerful than simply talking about it!
Relaxation is self-care!
While most teenagers do not need to be taught how to relax, those very ambitious ones are likely to need permission and even help in learning how to effectively and efficiently blow off steam. Help them to approach relaxation as they would approach a new subject, open-minded and trying different things to determine what works for them. Some may find exercise relaxing, while some may need a cognitive distraction (sometimes called “senseless fun,” an activity not dedicated to achievement) such as reading, family games, or television. Social time often is very effective relaxation for teenagers, and they should know that it is as important as sleep and studying for their performance. Some may find that a calming activity such as yoga or meditation recharges their batteries, whereas others may need noisy video games to feel renewed. Suggest that they should protect (just a little) time for relaxation even on their busiest days to help them develop good habits of self-care. Without consistent, reliable relaxation, ambitious young people are at risk for burnout or for impulsive and extreme behaviors such as binge-drinking.
Be on the lookout for red flags
In the same way that high performing athletes are at risk for stress fractures or other injuries of repetitive, intense physical activity, ambitious students are vulnerable to some of the problems that can follow sustained, intense cognitive effort. These risks go up if they are sleep deprived, stop exercising, or are socially isolated. Parents can be on the lookout for signs of depression or anxiety disorders, such as loss of energy, withdrawal from friends or beloved activities, persistent unhappiness or irritability (sustained over days to weeks), and of course morbid preoccupations.
Intense perfectionism is common among young people at risk for eating disorders, depression and self-injury, and anxiety disorders. Beyond recognizing signs, it is even more important for parents and pediatricians to equip ambitious young people to stay connected and ask for help if they experience a change in their emotional equilibrium. Suggest to your patients that they should never worry alone. They should ask for help if they are struggling to sleep, to sustain their motivation or effort, or notice feeling panicked, unusually tearful, or hopeless. Depression and anxiety are common and treatable problems in adolescents, but ambitious adolescents might be inclined to try to soldier through them. Caring adults should demystify and destigmatize mood and anxiety problems. You might point out that they would ask for help for a toothache or a painful knee joint, and that their mental health should be no different.
Many ambitious children have ambitious parents who might look back on their own adolescence and wonder if they were sufficiently balanced in their approach or whether they overreacted to failure. Sometimes honest sharing of successes, failures, and enduring dilemmas can build an empathic bridge from one generation to the next.
Dr. Swick is an attending psychiatrist in the division of child psychiatry at Massachusetts General Hospital, Boston, and director of the Parenting at a Challenging Time (PACT) Program at the Vernon Cancer Center at Newton Wellesley Hospital, also in Boston. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
Control of COPD Symptoms: Addressing an Unmet Need
This series for primary care physicians covers key topics in the management of chronic obstructive pulmonary disease (COPD) and asthma within the context of current national guidelines and clinical practice.
Click here to read the supplement
Randall Brown, MD, MPH, AE-C
Center for Managing Chronic Disease
University of Michigan, Ann Arbor
This series for primary care physicians covers key topics in the management of chronic obstructive pulmonary disease (COPD) and asthma within the context of current national guidelines and clinical practice.
Click here to read the supplement
Randall Brown, MD, MPH, AE-C
Center for Managing Chronic Disease
University of Michigan, Ann Arbor
This series for primary care physicians covers key topics in the management of chronic obstructive pulmonary disease (COPD) and asthma within the context of current national guidelines and clinical practice.
Click here to read the supplement
Randall Brown, MD, MPH, AE-C
Center for Managing Chronic Disease
University of Michigan, Ann Arbor
Counsel women against unnecessary prophylactic mastectomies
Women with breast cancer are much less likely to opt for contralateral prophylactic mastectomies if they know it won’t prolong their lives, according to a survey of 2,402 women with unilateral stage 0-II breast cancer.
Contralateral prophylactic mastectomy (CPM) – removing the healthy breast along with the cancerous one – is on the rise for early-stage, unilateral breast cancer because of “celebrity exposure and publicity,” said investigators led by Reshma Jagsi, MD, of the University of Michigan, Ann Arbor (JAMA Surg. 2016 Dec 21. doi: 10.1001/jamasurg.2016.4749).
CPM might make sense for women at genetic risk for breast cancer, like actress Angelina Jolie – who made headlines in 2013 when she opted for double mastectomy – but the survey found that nearly one in five women with no genetic risks also opted for CPM when their surgeons made no recommendation either way.
When surgeons advised against the procedure, the number fell to about 2%. Meanwhile, many women said their surgeons stayed silent on the issue, which is a problem, according to the investigators.
Overall, about 44% of women in the survey considered CPM, but just 38% of them said they knew that CPM didn’t improve survival for all women with breast cancer.
“Some patients may pursue CPM for cosmetic symmetry or other reasons. However, it is not clear that average-risk patients who choose CPM truly understand that it will not improve their survival or alter recurrence risk,” the investigators noted.
Surgeons’ knowledge and communication practices could be targets for quality improvement interventions, the investigators wrote. “Our findings should motivate surgeons to broach these difficult conversations with their patients, to make their recommendations clear, and to promote patients’ peace of mind by emphasizing how other treatments complement surgery to reduce the risk of both tumor recurrence and subsequent cancer development,” they said.
Women in the study were identified through the Surveillance Epidemiology and End Results (SEER) registries of Los Angeles County and Georgia. They were 62 years old, on average. CPM was associated with younger age, white race, higher educational level, family history, and private insurance.
The National Institutes of Health supported the study. Dr. Jagsi reported having no disclosures. A coauthor reported research funding from Myriad Genetics, Invitae, Ambry Genetics, GeneDx, and Genomic Health.
Although CPM is not associated with improved survival, it reduces the risk of contralateral breast cancer, and the significance of this fact to some patients should not be minimized.
As we move toward an ever-more personalized, patient-centered approach to care, we must thoughtfully weigh the balance between respecting patients’ preferences and leaving them with the long-term consequences associated with an “unnecessary” operation. For many women who choose CPM, the peace of mind associated with a reduced – albeit not eliminated – likelihood of subsequent cancer justifies the additional surgery and the potential attendant complications, even if the avoided cancer might not have actually shortened their lives. Furthermore, concerns about postsurgical cosmesis and symmetry can significantly affect the self-esteem of young women with breast cancer and affect their quality of life as much as, if not more than, concerns surrounding mortality and risk reduction.
Patients should be supported to make their own value-based medical decisions, but the medical community must continue to do its part to educate patients on the negligible benefits of this procedure and help to overcome the fears and misperceptions that often drive this decision.
Oluwadamilola M. Fayanju, MD, and E. Shelley Hwang, MD, are at Duke University in Durham, N.C. Their comments are adapted from an editorial (JAMA Surg. 2016 Dec 21. doi: 10.1001/jamasurg.2016.4750). They reported having no conflicts of interest.
Although CPM is not associated with improved survival, it reduces the risk of contralateral breast cancer, and the significance of this fact to some patients should not be minimized.
As we move toward an ever-more personalized, patient-centered approach to care, we must thoughtfully weigh the balance between respecting patients’ preferences and leaving them with the long-term consequences associated with an “unnecessary” operation. For many women who choose CPM, the peace of mind associated with a reduced – albeit not eliminated – likelihood of subsequent cancer justifies the additional surgery and the potential attendant complications, even if the avoided cancer might not have actually shortened their lives. Furthermore, concerns about postsurgical cosmesis and symmetry can significantly affect the self-esteem of young women with breast cancer and affect their quality of life as much as, if not more than, concerns surrounding mortality and risk reduction.
Patients should be supported to make their own value-based medical decisions, but the medical community must continue to do its part to educate patients on the negligible benefits of this procedure and help to overcome the fears and misperceptions that often drive this decision.
Oluwadamilola M. Fayanju, MD, and E. Shelley Hwang, MD, are at Duke University in Durham, N.C. Their comments are adapted from an editorial (JAMA Surg. 2016 Dec 21. doi: 10.1001/jamasurg.2016.4750). They reported having no conflicts of interest.
Although CPM is not associated with improved survival, it reduces the risk of contralateral breast cancer, and the significance of this fact to some patients should not be minimized.
As we move toward an ever-more personalized, patient-centered approach to care, we must thoughtfully weigh the balance between respecting patients’ preferences and leaving them with the long-term consequences associated with an “unnecessary” operation. For many women who choose CPM, the peace of mind associated with a reduced – albeit not eliminated – likelihood of subsequent cancer justifies the additional surgery and the potential attendant complications, even if the avoided cancer might not have actually shortened their lives. Furthermore, concerns about postsurgical cosmesis and symmetry can significantly affect the self-esteem of young women with breast cancer and affect their quality of life as much as, if not more than, concerns surrounding mortality and risk reduction.
Patients should be supported to make their own value-based medical decisions, but the medical community must continue to do its part to educate patients on the negligible benefits of this procedure and help to overcome the fears and misperceptions that often drive this decision.
Oluwadamilola M. Fayanju, MD, and E. Shelley Hwang, MD, are at Duke University in Durham, N.C. Their comments are adapted from an editorial (JAMA Surg. 2016 Dec 21. doi: 10.1001/jamasurg.2016.4750). They reported having no conflicts of interest.
Women with breast cancer are much less likely to opt for contralateral prophylactic mastectomies if they know it won’t prolong their lives, according to a survey of 2,402 women with unilateral stage 0-II breast cancer.
Contralateral prophylactic mastectomy (CPM) – removing the healthy breast along with the cancerous one – is on the rise for early-stage, unilateral breast cancer because of “celebrity exposure and publicity,” said investigators led by Reshma Jagsi, MD, of the University of Michigan, Ann Arbor (JAMA Surg. 2016 Dec 21. doi: 10.1001/jamasurg.2016.4749).
CPM might make sense for women at genetic risk for breast cancer, like actress Angelina Jolie – who made headlines in 2013 when she opted for double mastectomy – but the survey found that nearly one in five women with no genetic risks also opted for CPM when their surgeons made no recommendation either way.
When surgeons advised against the procedure, the number fell to about 2%. Meanwhile, many women said their surgeons stayed silent on the issue, which is a problem, according to the investigators.
Overall, about 44% of women in the survey considered CPM, but just 38% of them said they knew that CPM didn’t improve survival for all women with breast cancer.
“Some patients may pursue CPM for cosmetic symmetry or other reasons. However, it is not clear that average-risk patients who choose CPM truly understand that it will not improve their survival or alter recurrence risk,” the investigators noted.
Surgeons’ knowledge and communication practices could be targets for quality improvement interventions, the investigators wrote. “Our findings should motivate surgeons to broach these difficult conversations with their patients, to make their recommendations clear, and to promote patients’ peace of mind by emphasizing how other treatments complement surgery to reduce the risk of both tumor recurrence and subsequent cancer development,” they said.
Women in the study were identified through the Surveillance Epidemiology and End Results (SEER) registries of Los Angeles County and Georgia. They were 62 years old, on average. CPM was associated with younger age, white race, higher educational level, family history, and private insurance.
The National Institutes of Health supported the study. Dr. Jagsi reported having no disclosures. A coauthor reported research funding from Myriad Genetics, Invitae, Ambry Genetics, GeneDx, and Genomic Health.
Women with breast cancer are much less likely to opt for contralateral prophylactic mastectomies if they know it won’t prolong their lives, according to a survey of 2,402 women with unilateral stage 0-II breast cancer.
Contralateral prophylactic mastectomy (CPM) – removing the healthy breast along with the cancerous one – is on the rise for early-stage, unilateral breast cancer because of “celebrity exposure and publicity,” said investigators led by Reshma Jagsi, MD, of the University of Michigan, Ann Arbor (JAMA Surg. 2016 Dec 21. doi: 10.1001/jamasurg.2016.4749).
CPM might make sense for women at genetic risk for breast cancer, like actress Angelina Jolie – who made headlines in 2013 when she opted for double mastectomy – but the survey found that nearly one in five women with no genetic risks also opted for CPM when their surgeons made no recommendation either way.
When surgeons advised against the procedure, the number fell to about 2%. Meanwhile, many women said their surgeons stayed silent on the issue, which is a problem, according to the investigators.
Overall, about 44% of women in the survey considered CPM, but just 38% of them said they knew that CPM didn’t improve survival for all women with breast cancer.
“Some patients may pursue CPM for cosmetic symmetry or other reasons. However, it is not clear that average-risk patients who choose CPM truly understand that it will not improve their survival or alter recurrence risk,” the investigators noted.
Surgeons’ knowledge and communication practices could be targets for quality improvement interventions, the investigators wrote. “Our findings should motivate surgeons to broach these difficult conversations with their patients, to make their recommendations clear, and to promote patients’ peace of mind by emphasizing how other treatments complement surgery to reduce the risk of both tumor recurrence and subsequent cancer development,” they said.
Women in the study were identified through the Surveillance Epidemiology and End Results (SEER) registries of Los Angeles County and Georgia. They were 62 years old, on average. CPM was associated with younger age, white race, higher educational level, family history, and private insurance.
The National Institutes of Health supported the study. Dr. Jagsi reported having no disclosures. A coauthor reported research funding from Myriad Genetics, Invitae, Ambry Genetics, GeneDx, and Genomic Health.
FROM JAMA SURGERY
Key clinical point:
Major finding: Overall, about 44% of women in the survey considered CPM, but just 38% of them knew that it did not improve survival.
Data source: Survey of 2,402 women with unilateral stage 0-II breast cancer.
Disclosures: The National Institutes of Health supported the study. One investigator reported research funding from Myriad Genetics, Invitae, Ambry Genetics, GeneDx, and Genomic Health.
CMS finalizes cardiac pay bundles, but their future is unclear
The Centers for Medicare & Medicaid Services has finalized three cardiac payment bundles that will qualify as advanced alternative payment models under MACRA’s Quality Payment Program, but questions linger as to whether the bundles will survive in the Trump administration.
The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model. The three programs were proposed in July 2016 and finalized in a rule posted Dec. 20, and scheduled for publication in the Federal Register on Jan. 3, 2017.
The bundled payment model will place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas will be placed under this model and monitored for 5 years to test whether the model leads to improved outcomes and lower costs.
Physician participation will be voluntary; those who do participate will eligible for bonus payments as part of a Quality Payment Program advanced Alternative Payment Model (APM) when savings are generated, and responsible for penalties when costs exceed targets. Physician participation would begin in 2018.
CMS also finalized a program to test whether an incentive payment will increase the use of cardiac rehabilitation services.
Participating hospitals will receive an initial payment of $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare post-AMI or post-CABG, and $175 per service during the care period after 11 services. The care period runs parallel with the 90-day period for the AMI and CABG episode payment bundled.
“As we move from volume-based care to value-based care, this new path for cardiologists to participate in advanced alternative payment models under MACRA’s Quality Payment Program is a challenging step,” American College of Cardiology President Richard A. Chazal, MD, said in a statement. “It is our sincere hope that the end result will be opportunities for coordinated care and improvement in quality, while also decreasing costs for patients with heart attack or who undergo bypass surgery.”
The final rule also will test the Medicare ACO Track 1+ model, an accountable care organization that qualifies as an APM but has a lower risk of penalty than other ACOs, starting in 2018.
These new programs could be short-lived, depending on the direction taken by the Trump Administration. Rep. Tom Price, MD (R-Ga.), the incoming administration’s choice to lead the Health & Human Services department, was a lead cosigner to a Sept. 29 letter to Dr. Conway and CMS Acting Administrator Andy Slavitt that called on the agency to “cease all current and future planned mandatory initiatives” generating from the Centers for Medicare and Medicaid Innovation, which is where the bundles were developed. The letter said that the mandatory models “overhaul major payment systems, commandeer clinical decision-making, and dramatically alter the delivery of care.”
During the teleconference, Dr. Conway avoided answering questions about how the incoming administration might handle these models.
The final rule also offered a new bundle for patients requiring surgery after a hip fracture and provided updates to the Comprehensive Care for Joint Replacement (CJR) model.
The Centers for Medicare & Medicaid Services has finalized three cardiac payment bundles that will qualify as advanced alternative payment models under MACRA’s Quality Payment Program, but questions linger as to whether the bundles will survive in the Trump administration.
The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model. The three programs were proposed in July 2016 and finalized in a rule posted Dec. 20, and scheduled for publication in the Federal Register on Jan. 3, 2017.
The bundled payment model will place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas will be placed under this model and monitored for 5 years to test whether the model leads to improved outcomes and lower costs.
Physician participation will be voluntary; those who do participate will eligible for bonus payments as part of a Quality Payment Program advanced Alternative Payment Model (APM) when savings are generated, and responsible for penalties when costs exceed targets. Physician participation would begin in 2018.
CMS also finalized a program to test whether an incentive payment will increase the use of cardiac rehabilitation services.
Participating hospitals will receive an initial payment of $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare post-AMI or post-CABG, and $175 per service during the care period after 11 services. The care period runs parallel with the 90-day period for the AMI and CABG episode payment bundled.
“As we move from volume-based care to value-based care, this new path for cardiologists to participate in advanced alternative payment models under MACRA’s Quality Payment Program is a challenging step,” American College of Cardiology President Richard A. Chazal, MD, said in a statement. “It is our sincere hope that the end result will be opportunities for coordinated care and improvement in quality, while also decreasing costs for patients with heart attack or who undergo bypass surgery.”
The final rule also will test the Medicare ACO Track 1+ model, an accountable care organization that qualifies as an APM but has a lower risk of penalty than other ACOs, starting in 2018.
These new programs could be short-lived, depending on the direction taken by the Trump Administration. Rep. Tom Price, MD (R-Ga.), the incoming administration’s choice to lead the Health & Human Services department, was a lead cosigner to a Sept. 29 letter to Dr. Conway and CMS Acting Administrator Andy Slavitt that called on the agency to “cease all current and future planned mandatory initiatives” generating from the Centers for Medicare and Medicaid Innovation, which is where the bundles were developed. The letter said that the mandatory models “overhaul major payment systems, commandeer clinical decision-making, and dramatically alter the delivery of care.”
During the teleconference, Dr. Conway avoided answering questions about how the incoming administration might handle these models.
The final rule also offered a new bundle for patients requiring surgery after a hip fracture and provided updates to the Comprehensive Care for Joint Replacement (CJR) model.
The Centers for Medicare & Medicaid Services has finalized three cardiac payment bundles that will qualify as advanced alternative payment models under MACRA’s Quality Payment Program, but questions linger as to whether the bundles will survive in the Trump administration.
The bundles include the Acute Myocardial Infarction (AMI) model, the Coronary Artery Bypass Graft (CABG) model, and the Cardiac Rehabilitation Incentive Payment model. The three programs were proposed in July 2016 and finalized in a rule posted Dec. 20, and scheduled for publication in the Federal Register on Jan. 3, 2017.
The bundled payment model will place accountability for patient outcomes 90 days after discharge on the hospital where treatment occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas will be placed under this model and monitored for 5 years to test whether the model leads to improved outcomes and lower costs.
Physician participation will be voluntary; those who do participate will eligible for bonus payments as part of a Quality Payment Program advanced Alternative Payment Model (APM) when savings are generated, and responsible for penalties when costs exceed targets. Physician participation would begin in 2018.
CMS also finalized a program to test whether an incentive payment will increase the use of cardiac rehabilitation services.
Participating hospitals will receive an initial payment of $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare post-AMI or post-CABG, and $175 per service during the care period after 11 services. The care period runs parallel with the 90-day period for the AMI and CABG episode payment bundled.
“As we move from volume-based care to value-based care, this new path for cardiologists to participate in advanced alternative payment models under MACRA’s Quality Payment Program is a challenging step,” American College of Cardiology President Richard A. Chazal, MD, said in a statement. “It is our sincere hope that the end result will be opportunities for coordinated care and improvement in quality, while also decreasing costs for patients with heart attack or who undergo bypass surgery.”
The final rule also will test the Medicare ACO Track 1+ model, an accountable care organization that qualifies as an APM but has a lower risk of penalty than other ACOs, starting in 2018.
These new programs could be short-lived, depending on the direction taken by the Trump Administration. Rep. Tom Price, MD (R-Ga.), the incoming administration’s choice to lead the Health & Human Services department, was a lead cosigner to a Sept. 29 letter to Dr. Conway and CMS Acting Administrator Andy Slavitt that called on the agency to “cease all current and future planned mandatory initiatives” generating from the Centers for Medicare and Medicaid Innovation, which is where the bundles were developed. The letter said that the mandatory models “overhaul major payment systems, commandeer clinical decision-making, and dramatically alter the delivery of care.”
During the teleconference, Dr. Conway avoided answering questions about how the incoming administration might handle these models.
The final rule also offered a new bundle for patients requiring surgery after a hip fracture and provided updates to the Comprehensive Care for Joint Replacement (CJR) model.
FDA expands indication for continuous glucose monitoring system
People with diabetes have come a step closer to a life without multiple daily finger sticks. The with diabetes, the Food and Drug Administration announced .
“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the FDA statement.
The FDA based its decision on data from two clinical studies of 130 adults and children aged 2 years and older with diabetes. No serious adverse events were reported during a 7-day period when system readings were compared with blood glucose meter values and lab glucose measures.
The action comes just a few months after the agency approved the MiniMed 670G by Medtronic, a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses in patients aged 14 years and older. Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.
People with diabetes have come a step closer to a life without multiple daily finger sticks. The with diabetes, the Food and Drug Administration announced .
“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the FDA statement.
The FDA based its decision on data from two clinical studies of 130 adults and children aged 2 years and older with diabetes. No serious adverse events were reported during a 7-day period when system readings were compared with blood glucose meter values and lab glucose measures.
The action comes just a few months after the agency approved the MiniMed 670G by Medtronic, a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses in patients aged 14 years and older. Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.
People with diabetes have come a step closer to a life without multiple daily finger sticks. The with diabetes, the Food and Drug Administration announced .
“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the FDA statement.
The FDA based its decision on data from two clinical studies of 130 adults and children aged 2 years and older with diabetes. No serious adverse events were reported during a 7-day period when system readings were compared with blood glucose meter values and lab glucose measures.
The action comes just a few months after the agency approved the MiniMed 670G by Medtronic, a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses in patients aged 14 years and older. Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.