Pediatrics

A 3-and-a-half-year-old girl presented to a pediatrician’s office with complaints of vomiting and high fever (103.3°). She was seen by a nurse practitioner, who diagnosed gastroenteritis, prescribed fluid replacement and acetaminophen, and sent the child home.

The NP did not chart the child’s blood pressure, pulse, or respiratory rate. She did note swollen lymph nodes and absence of diarrhea. The NP performed a flu screen but did not order a rapid strep test or urinalysis.

Several hours later, the child was taken to the emergency department with shortness of breath, cough, congestion, tachycardia, hypoxia, dehydration, and lethargy. She was admitted to the pediatric ICU with diagnoses of pneumonia, acute respiratory distress, hypoxemia, neutropenia, and sepsis. She was given IV antibiotics.

Several hours later, the decision was made to transfer the patient to a regional medical center. During transfer, she suffered cardiopulmonary arrest while being placed on a ventilator for transport. Upon arrival at the hospital, she arrested again and required resuscitation for several hours until spontaneous circulation could not be restored.

An autopsy concluded the child died of sepsis and shock from Group A beta-hemolytic streptococcal infection.

It was argued that the NP failed to diagnose and treat streptococcal toxic shock syndrome at the time of the child’s presentation. In support of this contention, it was argued that the NP had failed to perform basic follow-up when the child’s flu test came back negative and that the child’s swollen lymph nodes and lack of diarrhea both mitigated against the NP’s diagnosis of gastroenteritis.

VERDICT

The parties in this case reached a $950,000 settlement.

Continue to: DISCUSSION

 

 

DISCUSSION

Every headache and fever could be an early meningitis, every vague abdominal pain an early appendicitis. So how do we handle innocuous-appearing cases with early, nonspecific symptoms of a very serious illness about to unfold?

We must start by following the Miyagi rule. In The Karate Kid, Mr. Miyagi advised that walking on the left or the right side of the road was safe, but walking in the middle would result, sooner or later, in “squish, just like grape.” Although he related this premise to karate, we can also apply it to medicine: See a patient or do not see a patient; but if you see a patient “so-so,” you will be squished—by the patient, by a plaintiff’s attorney, and/or by your state’s medical board.

A case such as this one strikes fear in the heart of anyone who has seen patients in an ambulatory setting. The initial presentation was modest: a toddler with vomiting and fever. We do not know what the other vital signs were, and we do not know whether the child appeared toxic. The lack of vital signs or recorded vital signs represent half-measures. The patient’s vitals could have been normal, and the NP’s actions could have been fully defensible. The problem is, we don’t know—and the clinician is on the hook.

All patients require vital signs. They must be done; they must be complete, and they must be recorded. At a minimum, temperature, blood pressure, respiratory rate, and (generally) O₂ saturation are required. Some specialties may have other requirements (eg, fingerstick glucose for patients with diabetes, visual acuity testing for those with eye complaints). A full list of data you should be obtaining is practice specific and beyond the scope of this article; the point is, decide on the relevant set of vitals and intake data and be sure it is recorded at every visit.

Failure to obtain and record vital signs—as seen in this case—is sloppy practice, difficult to defend, and sets up an inference of negligence. Even when the care is perfect (and without bad outcome), if the medical board reviews the record for any reason, you will be sanctioned for “failure to keep adequate and accurate medical records” and your license burdened. Here, we are told the defendant NP “did not chart the child’s blood pressure, pulse, or respiratory rate.” I am willing to bet the NP was not responsible for charting the values in the normal course of practice, but see how responsibility is parked with the clinician? If intake staff do not record vital signs, politely (yet firmly) insist they do so.

Continue to: Furthermore, the disposition of many child visits...

Furthermore, the disposition of many child visits turns on whether the patient “appeared toxic.” Any child’s condition could worsen after evaluation—and in litigation, parents, friends, and family will testify the patient was extremely ill, they “knew something was wrong,” and the clinician ignored their loved one. Thus, the jury will be invited to reconstruct how the child appeared.

When assessing children and the question of “toxic appearance” arises, don’t state a conclusion—paint a picture. Don’t merely state “child appeared nontoxic.” Use your powers of observation to record why they appear nontoxic: “Child sitting up, watching Moana on parent’s phone, smiling and laughing appropriately.” Get interactive; some pediatric providers carry a small vial of bubbles with them and record the child’s response to bubble-making (“Child appropriately reaching for bubbles, smiling, holding one on finger”). The cost is less than $1 for the bubbles, plus the documentation time. The benefit is that it paints a clear picture for the jury of a child responding appropriately. And if your observations suggest a child who is at least unwell—if the movie is poorly received or the bubbles prompt the child to scream or bury her face in her mom’s shoulder—you can consider oral antipyretics/analgesics, fluid, and re-observation.

Another way to create a strong and defensible record is to use patient quotations. These can be extremely helpful to your defense in a malpractice action; as an attorney, I have searched 8,000 pages of records in a medical malpractice case, hoping to find a clear description from a human (not a template) of how a patient looked. Make it clear by adding patient remarks to the chart—just remember that “the only thing that belongs in quotes is what comes out of the patient’s mouth.” Words from an 8-year-old boy— such as “My brother found a legendary scar [a reference to Fortnite] and almost won”—may seem silly, but this documentation itself could win your case.

With teenagers, you may have to ask more questions to glean something suitable; you could ask a 13-year-old her favorite sport and when her one-word answer is “Lacrosse,” ask why. Even if the response is “Because, I don’t know, it’s exciting. There are a lot of goals,” write that down exactly (along with any other observations, such as Teen texting on her phone). These notations tell the plaintiff’s attorney, the judge, and the jury that the patient was behaving normally and interacting with the environment. Should this teen later deteriorate with meningitis, the plaintiff will claim she was toxic in the office. The medical record, however, will show that the patient’s condition changed, and it was a departure from how she looked in your office.

Also, it never hurts to get backup. In any close call, ask the nurse to reevaluate the patient as to whether he or she is “toxic appearing” or is interacting normally with the environment. Have the nurse or medical assistant record facts, such as “patient trying to make a plane out of two tongue depressors, pretending to land it on sister’s leg.” This will create a strong and defensible record: two clinicians relaying two sets of detailed observations.

Continue to: Likewise, encourage intake staff to document...

Likewise, encourage intake staff to document what they see rather than what they conclude from it. Buzzwords (eg, listless, lethargic) should be avoided. If such characterizations find their way into the record, you must take active steps to address them. Either agree with the characterization and perform appropriate work-up, or establish why you do not agree using the methods described (detailed description, verification by another clinician).

Taking these steps will help to protect you in the event of a changing clinical course. But also be wary of those predictable circumstances that lead you into Mr. Miyagi’s middle of the road (what I call “half-visits”): a quick look at a sibling in the room during a patient’s appointment; a “curbside consult” on the medical assistant’s child; the neighborhood acquaintance who asks you to “just take a look.” Why are these dangerous? Because they remove the clinician from his or her usual routine: proper examination on a properly undressed patient, formal assessment of vital signs, and review of relevant history in the chart, among other things. (In this way, phone and email communications with patients require similar caution.) Skipping the routine leads to shortcuts, and shortcuts lead to bad medicine. And if that doesn’t worry you, remember: All these scenarios create a full legal duty and clinician/patient relationship—making them potential pathways to misdiagnosis and eventual loss of license.

IN SUMMARY

Don’t be party to a “half-visit”; insist on full vital signs and a complete visit following your usual routine. Use observational powers and patient quotations to paint a picture of how a patient looked, get backup from another clinician with similar observations. If you can’t document a reassuring record, protect the patient and make the required intervention.

A 3-and-a-half-year-old girl presented to a pediatrician’s office with complaints of vomiting and high fever (103.3°). She was seen by a nurse practitioner, who diagnosed gastroenteritis, prescribed fluid replacement and acetaminophen, and sent the child home.

The NP did not chart the child’s blood pressure, pulse, or respiratory rate. She did note swollen lymph nodes and absence of diarrhea. The NP performed a flu screen but did not order a rapid strep test or urinalysis.

Several hours later, the child was taken to the emergency department with shortness of breath, cough, congestion, tachycardia, hypoxia, dehydration, and lethargy. She was admitted to the pediatric ICU with diagnoses of pneumonia, acute respiratory distress, hypoxemia, neutropenia, and sepsis. She was given IV antibiotics.

Several hours later, the decision was made to transfer the patient to a regional medical center. During transfer, she suffered cardiopulmonary arrest while being placed on a ventilator for transport. Upon arrival at the hospital, she arrested again and required resuscitation for several hours until spontaneous circulation could not be restored.

An autopsy concluded the child died of sepsis and shock from Group A beta-hemolytic streptococcal infection.

It was argued that the NP failed to diagnose and treat streptococcal toxic shock syndrome at the time of the child’s presentation. In support of this contention, it was argued that the NP had failed to perform basic follow-up when the child’s flu test came back negative and that the child’s swollen lymph nodes and lack of diarrhea both mitigated against the NP’s diagnosis of gastroenteritis.

VERDICT

The parties in this case reached a $950,000 settlement.

Continue to: DISCUSSION

 

 

DISCUSSION

Every headache and fever could be an early meningitis, every vague abdominal pain an early appendicitis. So how do we handle innocuous-appearing cases with early, nonspecific symptoms of a very serious illness about to unfold?

We must start by following the Miyagi rule. In The Karate Kid, Mr. Miyagi advised that walking on the left or the right side of the road was safe, but walking in the middle would result, sooner or later, in “squish, just like grape.” Although he related this premise to karate, we can also apply it to medicine: See a patient or do not see a patient; but if you see a patient “so-so,” you will be squished—by the patient, by a plaintiff’s attorney, and/or by your state’s medical board.

A case such as this one strikes fear in the heart of anyone who has seen patients in an ambulatory setting. The initial presentation was modest: a toddler with vomiting and fever. We do not know what the other vital signs were, and we do not know whether the child appeared toxic. The lack of vital signs or recorded vital signs represent half-measures. The patient’s vitals could have been normal, and the NP’s actions could have been fully defensible. The problem is, we don’t know—and the clinician is on the hook.

All patients require vital signs. They must be done; they must be complete, and they must be recorded. At a minimum, temperature, blood pressure, respiratory rate, and (generally) O₂ saturation are required. Some specialties may have other requirements (eg, fingerstick glucose for patients with diabetes, visual acuity testing for those with eye complaints). A full list of data you should be obtaining is practice specific and beyond the scope of this article; the point is, decide on the relevant set of vitals and intake data and be sure it is recorded at every visit.

Failure to obtain and record vital signs—as seen in this case—is sloppy practice, difficult to defend, and sets up an inference of negligence. Even when the care is perfect (and without bad outcome), if the medical board reviews the record for any reason, you will be sanctioned for “failure to keep adequate and accurate medical records” and your license burdened. Here, we are told the defendant NP “did not chart the child’s blood pressure, pulse, or respiratory rate.” I am willing to bet the NP was not responsible for charting the values in the normal course of practice, but see how responsibility is parked with the clinician? If intake staff do not record vital signs, politely (yet firmly) insist they do so.

Continue to: Furthermore, the disposition of many child visits...

Furthermore, the disposition of many child visits turns on whether the patient “appeared toxic.” Any child’s condition could worsen after evaluation—and in litigation, parents, friends, and family will testify the patient was extremely ill, they “knew something was wrong,” and the clinician ignored their loved one. Thus, the jury will be invited to reconstruct how the child appeared.

When assessing children and the question of “toxic appearance” arises, don’t state a conclusion—paint a picture. Don’t merely state “child appeared nontoxic.” Use your powers of observation to record why they appear nontoxic: “Child sitting up, watching Moana on parent’s phone, smiling and laughing appropriately.” Get interactive; some pediatric providers carry a small vial of bubbles with them and record the child’s response to bubble-making (“Child appropriately reaching for bubbles, smiling, holding one on finger”). The cost is less than $1 for the bubbles, plus the documentation time. The benefit is that it paints a clear picture for the jury of a child responding appropriately. And if your observations suggest a child who is at least unwell—if the movie is poorly received or the bubbles prompt the child to scream or bury her face in her mom’s shoulder—you can consider oral antipyretics/analgesics, fluid, and re-observation.

Another way to create a strong and defensible record is to use patient quotations. These can be extremely helpful to your defense in a malpractice action; as an attorney, I have searched 8,000 pages of records in a medical malpractice case, hoping to find a clear description from a human (not a template) of how a patient looked. Make it clear by adding patient remarks to the chart—just remember that “the only thing that belongs in quotes is what comes out of the patient’s mouth.” Words from an 8-year-old boy— such as “My brother found a legendary scar [a reference to Fortnite] and almost won”—may seem silly, but this documentation itself could win your case.

With teenagers, you may have to ask more questions to glean something suitable; you could ask a 13-year-old her favorite sport and when her one-word answer is “Lacrosse,” ask why. Even if the response is “Because, I don’t know, it’s exciting. There are a lot of goals,” write that down exactly (along with any other observations, such as Teen texting on her phone). These notations tell the plaintiff’s attorney, the judge, and the jury that the patient was behaving normally and interacting with the environment. Should this teen later deteriorate with meningitis, the plaintiff will claim she was toxic in the office. The medical record, however, will show that the patient’s condition changed, and it was a departure from how she looked in your office.

Also, it never hurts to get backup. In any close call, ask the nurse to reevaluate the patient as to whether he or she is “toxic appearing” or is interacting normally with the environment. Have the nurse or medical assistant record facts, such as “patient trying to make a plane out of two tongue depressors, pretending to land it on sister’s leg.” This will create a strong and defensible record: two clinicians relaying two sets of detailed observations.

Continue to: Likewise, encourage intake staff to document...

Likewise, encourage intake staff to document what they see rather than what they conclude from it. Buzzwords (eg, listless, lethargic) should be avoided. If such characterizations find their way into the record, you must take active steps to address them. Either agree with the characterization and perform appropriate work-up, or establish why you do not agree using the methods described (detailed description, verification by another clinician).

Taking these steps will help to protect you in the event of a changing clinical course. But also be wary of those predictable circumstances that lead you into Mr. Miyagi’s middle of the road (what I call “half-visits”): a quick look at a sibling in the room during a patient’s appointment; a “curbside consult” on the medical assistant’s child; the neighborhood acquaintance who asks you to “just take a look.” Why are these dangerous? Because they remove the clinician from his or her usual routine: proper examination on a properly undressed patient, formal assessment of vital signs, and review of relevant history in the chart, among other things. (In this way, phone and email communications with patients require similar caution.) Skipping the routine leads to shortcuts, and shortcuts lead to bad medicine. And if that doesn’t worry you, remember: All these scenarios create a full legal duty and clinician/patient relationship—making them potential pathways to misdiagnosis and eventual loss of license.

IN SUMMARY

Don’t be party to a “half-visit”; insist on full vital signs and a complete visit following your usual routine. Use observational powers and patient quotations to paint a picture of how a patient looked, get backup from another clinician with similar observations. If you can’t document a reassuring record, protect the patient and make the required intervention.

A 3-and-a-half-year-old girl presented to a pediatrician’s office with complaints of vomiting and high fever (103.3°). She was seen by a nurse practitioner, who diagnosed gastroenteritis, prescribed fluid replacement and acetaminophen, and sent the child home.

The NP did not chart the child’s blood pressure, pulse, or respiratory rate. She did note swollen lymph nodes and absence of diarrhea. The NP performed a flu screen but did not order a rapid strep test or urinalysis.

Several hours later, the child was taken to the emergency department with shortness of breath, cough, congestion, tachycardia, hypoxia, dehydration, and lethargy. She was admitted to the pediatric ICU with diagnoses of pneumonia, acute respiratory distress, hypoxemia, neutropenia, and sepsis. She was given IV antibiotics.

Several hours later, the decision was made to transfer the patient to a regional medical center. During transfer, she suffered cardiopulmonary arrest while being placed on a ventilator for transport. Upon arrival at the hospital, she arrested again and required resuscitation for several hours until spontaneous circulation could not be restored.

An autopsy concluded the child died of sepsis and shock from Group A beta-hemolytic streptococcal infection.

It was argued that the NP failed to diagnose and treat streptococcal toxic shock syndrome at the time of the child’s presentation. In support of this contention, it was argued that the NP had failed to perform basic follow-up when the child’s flu test came back negative and that the child’s swollen lymph nodes and lack of diarrhea both mitigated against the NP’s diagnosis of gastroenteritis.

VERDICT

The parties in this case reached a $950,000 settlement.

Continue to: DISCUSSION

 

 

DISCUSSION

Every headache and fever could be an early meningitis, every vague abdominal pain an early appendicitis. So how do we handle innocuous-appearing cases with early, nonspecific symptoms of a very serious illness about to unfold?

We must start by following the Miyagi rule. In The Karate Kid, Mr. Miyagi advised that walking on the left or the right side of the road was safe, but walking in the middle would result, sooner or later, in “squish, just like grape.” Although he related this premise to karate, we can also apply it to medicine: See a patient or do not see a patient; but if you see a patient “so-so,” you will be squished—by the patient, by a plaintiff’s attorney, and/or by your state’s medical board.

A case such as this one strikes fear in the heart of anyone who has seen patients in an ambulatory setting. The initial presentation was modest: a toddler with vomiting and fever. We do not know what the other vital signs were, and we do not know whether the child appeared toxic. The lack of vital signs or recorded vital signs represent half-measures. The patient’s vitals could have been normal, and the NP’s actions could have been fully defensible. The problem is, we don’t know—and the clinician is on the hook.

All patients require vital signs. They must be done; they must be complete, and they must be recorded. At a minimum, temperature, blood pressure, respiratory rate, and (generally) O₂ saturation are required. Some specialties may have other requirements (eg, fingerstick glucose for patients with diabetes, visual acuity testing for those with eye complaints). A full list of data you should be obtaining is practice specific and beyond the scope of this article; the point is, decide on the relevant set of vitals and intake data and be sure it is recorded at every visit.

Failure to obtain and record vital signs—as seen in this case—is sloppy practice, difficult to defend, and sets up an inference of negligence. Even when the care is perfect (and without bad outcome), if the medical board reviews the record for any reason, you will be sanctioned for “failure to keep adequate and accurate medical records” and your license burdened. Here, we are told the defendant NP “did not chart the child’s blood pressure, pulse, or respiratory rate.” I am willing to bet the NP was not responsible for charting the values in the normal course of practice, but see how responsibility is parked with the clinician? If intake staff do not record vital signs, politely (yet firmly) insist they do so.

Continue to: Furthermore, the disposition of many child visits...

Furthermore, the disposition of many child visits turns on whether the patient “appeared toxic.” Any child’s condition could worsen after evaluation—and in litigation, parents, friends, and family will testify the patient was extremely ill, they “knew something was wrong,” and the clinician ignored their loved one. Thus, the jury will be invited to reconstruct how the child appeared.

When assessing children and the question of “toxic appearance” arises, don’t state a conclusion—paint a picture. Don’t merely state “child appeared nontoxic.” Use your powers of observation to record why they appear nontoxic: “Child sitting up, watching Moana on parent’s phone, smiling and laughing appropriately.” Get interactive; some pediatric providers carry a small vial of bubbles with them and record the child’s response to bubble-making (“Child appropriately reaching for bubbles, smiling, holding one on finger”). The cost is less than $1 for the bubbles, plus the documentation time. The benefit is that it paints a clear picture for the jury of a child responding appropriately. And if your observations suggest a child who is at least unwell—if the movie is poorly received or the bubbles prompt the child to scream or bury her face in her mom’s shoulder—you can consider oral antipyretics/analgesics, fluid, and re-observation.

Another way to create a strong and defensible record is to use patient quotations. These can be extremely helpful to your defense in a malpractice action; as an attorney, I have searched 8,000 pages of records in a medical malpractice case, hoping to find a clear description from a human (not a template) of how a patient looked. Make it clear by adding patient remarks to the chart—just remember that “the only thing that belongs in quotes is what comes out of the patient’s mouth.” Words from an 8-year-old boy— such as “My brother found a legendary scar [a reference to Fortnite] and almost won”—may seem silly, but this documentation itself could win your case.

With teenagers, you may have to ask more questions to glean something suitable; you could ask a 13-year-old her favorite sport and when her one-word answer is “Lacrosse,” ask why. Even if the response is “Because, I don’t know, it’s exciting. There are a lot of goals,” write that down exactly (along with any other observations, such as Teen texting on her phone). These notations tell the plaintiff’s attorney, the judge, and the jury that the patient was behaving normally and interacting with the environment. Should this teen later deteriorate with meningitis, the plaintiff will claim she was toxic in the office. The medical record, however, will show that the patient’s condition changed, and it was a departure from how she looked in your office.

Also, it never hurts to get backup. In any close call, ask the nurse to reevaluate the patient as to whether he or she is “toxic appearing” or is interacting normally with the environment. Have the nurse or medical assistant record facts, such as “patient trying to make a plane out of two tongue depressors, pretending to land it on sister’s leg.” This will create a strong and defensible record: two clinicians relaying two sets of detailed observations.

Continue to: Likewise, encourage intake staff to document...

Likewise, encourage intake staff to document what they see rather than what they conclude from it. Buzzwords (eg, listless, lethargic) should be avoided. If such characterizations find their way into the record, you must take active steps to address them. Either agree with the characterization and perform appropriate work-up, or establish why you do not agree using the methods described (detailed description, verification by another clinician).

Taking these steps will help to protect you in the event of a changing clinical course. But also be wary of those predictable circumstances that lead you into Mr. Miyagi’s middle of the road (what I call “half-visits”): a quick look at a sibling in the room during a patient’s appointment; a “curbside consult” on the medical assistant’s child; the neighborhood acquaintance who asks you to “just take a look.” Why are these dangerous? Because they remove the clinician from his or her usual routine: proper examination on a properly undressed patient, formal assessment of vital signs, and review of relevant history in the chart, among other things. (In this way, phone and email communications with patients require similar caution.) Skipping the routine leads to shortcuts, and shortcuts lead to bad medicine. And if that doesn’t worry you, remember: All these scenarios create a full legal duty and clinician/patient relationship—making them potential pathways to misdiagnosis and eventual loss of license.

IN SUMMARY

Don’t be party to a “half-visit”; insist on full vital signs and a complete visit following your usual routine. Use observational powers and patient quotations to paint a picture of how a patient looked, get backup from another clinician with similar observations. If you can’t document a reassuring record, protect the patient and make the required intervention.

Newborns who develop neonatal abstinence syndrome (NAS) caused by chronic maternal opioid use during pregnancy are at risk of significantly smaller head circumference (HC), reported Craig V. Towers, MD, and his associates at the University of Tennessee Medical Center in Knoxville in Pediatrics.

In the first large prospective cohort study to compare HC in newborns being treated for NAS, a total of 858 neonates, including 429 with NAS and 429 controls, were enrolled and assessed at the University of Tennessee Medical Center, Knoxville, from April 1, 2014, to Dec. 31, 2016.

SOURCE: Towers CV et al. Pediatrics. 2019;143(1):e20180541.

Newborns who develop neonatal abstinence syndrome (NAS) caused by chronic maternal opioid use during pregnancy are at risk of significantly smaller head circumference (HC), reported Craig V. Towers, MD, and his associates at the University of Tennessee Medical Center in Knoxville in Pediatrics.

In the first large prospective cohort study to compare HC in newborns being treated for NAS, a total of 858 neonates, including 429 with NAS and 429 controls, were enrolled and assessed at the University of Tennessee Medical Center, Knoxville, from April 1, 2014, to Dec. 31, 2016.

SOURCE: Towers CV et al. Pediatrics. 2019;143(1):e20180541.

Newborns who develop neonatal abstinence syndrome (NAS) caused by chronic maternal opioid use during pregnancy are at risk of significantly smaller head circumference (HC), reported Craig V. Towers, MD, and his associates at the University of Tennessee Medical Center in Knoxville in Pediatrics.

In the first large prospective cohort study to compare HC in newborns being treated for NAS, a total of 858 neonates, including 429 with NAS and 429 controls, were enrolled and assessed at the University of Tennessee Medical Center, Knoxville, from April 1, 2014, to Dec. 31, 2016.

SOURCE: Towers CV et al. Pediatrics. 2019;143(1):e20180541.

While many pediatric clinicians have not frequently managed newborns of mothers with reactive syphilis serology, increased adult syphilis may change that.¹

Diagnosing/managing congenital syphilis is not always clear cut. A positive rapid plasma reagin (RPR) titer in a newborn may not indicate congenital infection but merely may reflect transplacental, passively acquired maternal IgG from the mother’s current or previous infection rather than antibodies produced by the newborn. Because currently no IgM assay for syphilis is recommended by the Centers for Disease Control and Prevention for newborn testing, we must deal with IgG test results.

Often initial management decisions are needed while the infant’s status is evolving. The questions to answer to make final decisions include the following²:

• Was the mother actively infected with Treponema pallidum during pregnancy?
• If so, was the mother appropriately treated and when?
• Does the infant have any clinical, laboratory, or radiographic evidence of syphilis?
• How do the mother’s and infant’s nontreponemal serologic titers (NTT) compare at delivery using the same test?

Note: All infants assessed for congenital syphilis need a full evaluation for HIV.
 

Managing the infant of a mother with positive tests^3,4

All such neonates need an examination for evidence of congenital syphilis. The clinical signs of congenital syphilis in neonates include nonimmune hydrops, jaundice, hepatosplenomegaly, rhinitis, skin rash, and pseudoparalysis of extremity. Also, consider dark-field examination or polymerase chain reaction (PCR) of lesions (such as bullae) or secretions (nasal). If available, have the placenta examined histologically (silver stain) or by PCR (Clinical Laboratory Improvement Amendments–validated test). Skeletal radiographic surveys are more useful for stillborn than live born infants. (The complete algorithm can be found in Figure 3.10 of reference 4.)

Order a quantitative NTT, using the Venereal Disease Research Laboratory (VDRL) test or RPR test on neonatal serum. Umbilical cord blood is not appropriate because of potential maternal blood contamination, which could give a false-positive result, or Wharton’s jelly, which could give a false-negative result. Use of treponemal-specific tests that are used for maternal diagnosis – such as T. pallidum particle agglutination (TP-PA), T. pallidum enzyme-linked immunosorbent assay (TP-EIA), fluorescent treponemal antibody absorption (FTA-ABS) test, or T. pallidum chemiluminescence immunoassay (TP-CIA) – on neonatal serum is not recommended because of difficulties in interpretation.

Diagnostic results allow designation of an infant into one of four CDC categories: proven/highly probable syphilis; possible syphilis; syphilis less likely; and syphilis unlikely. Treatment recommendations are based on these categories.

Proven or highly probable syphilis

There are two alternative recommended 10-day treatment regimens.

A. Aqueous crystalline penicillin G 100,000-150,000 U/kg per day by IV at 50,000 U/kg per dose, given every 12 hours through 7 days of age or every 8 hours if greater than 7 days old.

B. Procaine penicillin G at 50,000 U/kg per dose intramuscularly in one dose each day.

More than 1 day of missed therapy requires restarting a new 10-day course. Use of other antimicrobial agents (such as ampicillin) is not validated, so any empiric ampicillin initially given for possible sepsis does not count toward the 10-day penicillin regimen. If nonpenicillin drugs must be used, close serologic follow-up must occur to ensure adequacy of response to therapy.
 

Possible syphilis

There are three alternative regimens, the same two as in proven/highly probable syphilis (above) plus a single-dose option

A. Aqueous crystalline penicillin G, as described above.

B. Procaine penicillin G, as described above.

C. Benzathine penicillin G at 50,000 U/kg per dose intramuscularly in a single dose.

Note: To be eligible for regimen C, an infant must have a complete evaluation that is normal (cerebrospinal fluid [CSF] examination, long-bone radiographs, and complete blood count with platelet count) and follow-up must be assured. Exception: Neonates born to mothers with untreated early syphilis at the time of delivery are at increased risk for congenital syphilis, and the 10-day course of penicillin G may be considered even if the complete evaluation is normal and follow-up is certain.
 

Less likely syphilis

One antibiotic regimen is available, but no treatment also may be an option.

A. Benzathine penicillin G as described above.

B. If mother’s NTT has decreased at least fourfold after appropriate early syphilis therapy or remained stably low, which indicates latent syphilis (VDRL less than 1:2; RPR less than 1:4), no treatment is an option but requires repeat serology every 2-3 months until infant is 6 months old.

Unlikely syphilis

No treatment is recommended unless follow-up is uncertain, in which case it is appropriate to give the infant benzathine penicillin G as described above.

Infant with positive NTT at birth

All neonates with reactive NTT need careful follow-up examinations and repeat NTT every 2-3 months until nonreactive. NTT in infants who are not treated because of less likely or unlikely syphilis status should drop by 3 months and be nonreactive by 6 months; this indicates NTT was passively transferred maternal IgG. If NTT remains reactive at 6 months, the infant is likely infected and needs treatment. Persistent NTT at 6-12 months in treated neonates should trigger repeat CSF examination and infectious diseases consultation about a possible repeat of the 10-day penicillin G regimen. If the mother was seroreactive, but the newborn’s NTT was negative at birth, testing of the infant’s NTT needs repeating at 3 months to exclude the possibility that the congenital syphilis was incubating when prior testing occurred at birth. Note: Treponemal-specific tests are not useful in assessing treatment because detectable maternal IgG treponemal antibody can persist at least 15 months.

Neonates with abnormal CSF at birth

Repeat cerebrospinal fluid evaluation every 6 months until results normalize. Persistently reactive CSF VDRL or abnormal CSF indexes not caused by another known cause requires retreatment for possible neurosyphilis, as well as consultation with an expert.

Summary

Decisions on managing infants of mothers with positive syphilis testing can be difficult. NTT are the essential test for newborns and some degree of laboratory or imaging work up often are needed. Consider consulting an expert in infectious diseases and/or perinatology if the gray areas do not readily become clear. Treatment of the correct patients with the right drug for the right duration remains the goal, as usual.

Dr. Harrison is a professor of pediatrics at University of Missouri-Kansas City and Director of Research Affairs in the pediatric infectious diseases division at Children’s Mercy Hospital – Kansas City. He said he had no relevant financial disclosures. Email him at pdnews@mdedge.com.

References

1. MMWR. 2015 Nov 13;64(44);1241-5.

2. “Congenital Syphilis,” 2015 Sexually Transmitted Diseases Treatment Guidelines.

3. “Syphilis During Pregnancy,” 2015 Sexually Transmitted Diseases Treatment Guidelines.

4. Syphilis – Section 3: Summaries of Infectious Diseases. Red Book Online. 2018.
 

While many pediatric clinicians have not frequently managed newborns of mothers with reactive syphilis serology, increased adult syphilis may change that.¹

Diagnosing/managing congenital syphilis is not always clear cut. A positive rapid plasma reagin (RPR) titer in a newborn may not indicate congenital infection but merely may reflect transplacental, passively acquired maternal IgG from the mother’s current or previous infection rather than antibodies produced by the newborn. Because currently no IgM assay for syphilis is recommended by the Centers for Disease Control and Prevention for newborn testing, we must deal with IgG test results.

Often initial management decisions are needed while the infant’s status is evolving. The questions to answer to make final decisions include the following²:

• Was the mother actively infected with Treponema pallidum during pregnancy?
• If so, was the mother appropriately treated and when?
• Does the infant have any clinical, laboratory, or radiographic evidence of syphilis?
• How do the mother’s and infant’s nontreponemal serologic titers (NTT) compare at delivery using the same test?

Note: All infants assessed for congenital syphilis need a full evaluation for HIV.
 

Managing the infant of a mother with positive tests^3,4

All such neonates need an examination for evidence of congenital syphilis. The clinical signs of congenital syphilis in neonates include nonimmune hydrops, jaundice, hepatosplenomegaly, rhinitis, skin rash, and pseudoparalysis of extremity. Also, consider dark-field examination or polymerase chain reaction (PCR) of lesions (such as bullae) or secretions (nasal). If available, have the placenta examined histologically (silver stain) or by PCR (Clinical Laboratory Improvement Amendments–validated test). Skeletal radiographic surveys are more useful for stillborn than live born infants. (The complete algorithm can be found in Figure 3.10 of reference 4.)

Order a quantitative NTT, using the Venereal Disease Research Laboratory (VDRL) test or RPR test on neonatal serum. Umbilical cord blood is not appropriate because of potential maternal blood contamination, which could give a false-positive result, or Wharton’s jelly, which could give a false-negative result. Use of treponemal-specific tests that are used for maternal diagnosis – such as T. pallidum particle agglutination (TP-PA), T. pallidum enzyme-linked immunosorbent assay (TP-EIA), fluorescent treponemal antibody absorption (FTA-ABS) test, or T. pallidum chemiluminescence immunoassay (TP-CIA) – on neonatal serum is not recommended because of difficulties in interpretation.

Diagnostic results allow designation of an infant into one of four CDC categories: proven/highly probable syphilis; possible syphilis; syphilis less likely; and syphilis unlikely. Treatment recommendations are based on these categories.

Proven or highly probable syphilis

There are two alternative recommended 10-day treatment regimens.

A. Aqueous crystalline penicillin G 100,000-150,000 U/kg per day by IV at 50,000 U/kg per dose, given every 12 hours through 7 days of age or every 8 hours if greater than 7 days old.

B. Procaine penicillin G at 50,000 U/kg per dose intramuscularly in one dose each day.

More than 1 day of missed therapy requires restarting a new 10-day course. Use of other antimicrobial agents (such as ampicillin) is not validated, so any empiric ampicillin initially given for possible sepsis does not count toward the 10-day penicillin regimen. If nonpenicillin drugs must be used, close serologic follow-up must occur to ensure adequacy of response to therapy.
 

Possible syphilis

There are three alternative regimens, the same two as in proven/highly probable syphilis (above) plus a single-dose option

A. Aqueous crystalline penicillin G, as described above.

B. Procaine penicillin G, as described above.

C. Benzathine penicillin G at 50,000 U/kg per dose intramuscularly in a single dose.

Note: To be eligible for regimen C, an infant must have a complete evaluation that is normal (cerebrospinal fluid [CSF] examination, long-bone radiographs, and complete blood count with platelet count) and follow-up must be assured. Exception: Neonates born to mothers with untreated early syphilis at the time of delivery are at increased risk for congenital syphilis, and the 10-day course of penicillin G may be considered even if the complete evaluation is normal and follow-up is certain.
 

Less likely syphilis

One antibiotic regimen is available, but no treatment also may be an option.

A. Benzathine penicillin G as described above.

B. If mother’s NTT has decreased at least fourfold after appropriate early syphilis therapy or remained stably low, which indicates latent syphilis (VDRL less than 1:2; RPR less than 1:4), no treatment is an option but requires repeat serology every 2-3 months until infant is 6 months old.

Unlikely syphilis

No treatment is recommended unless follow-up is uncertain, in which case it is appropriate to give the infant benzathine penicillin G as described above.

Infant with positive NTT at birth

All neonates with reactive NTT need careful follow-up examinations and repeat NTT every 2-3 months until nonreactive. NTT in infants who are not treated because of less likely or unlikely syphilis status should drop by 3 months and be nonreactive by 6 months; this indicates NTT was passively transferred maternal IgG. If NTT remains reactive at 6 months, the infant is likely infected and needs treatment. Persistent NTT at 6-12 months in treated neonates should trigger repeat CSF examination and infectious diseases consultation about a possible repeat of the 10-day penicillin G regimen. If the mother was seroreactive, but the newborn’s NTT was negative at birth, testing of the infant’s NTT needs repeating at 3 months to exclude the possibility that the congenital syphilis was incubating when prior testing occurred at birth. Note: Treponemal-specific tests are not useful in assessing treatment because detectable maternal IgG treponemal antibody can persist at least 15 months.

Neonates with abnormal CSF at birth

Repeat cerebrospinal fluid evaluation every 6 months until results normalize. Persistently reactive CSF VDRL or abnormal CSF indexes not caused by another known cause requires retreatment for possible neurosyphilis, as well as consultation with an expert.

Summary

Decisions on managing infants of mothers with positive syphilis testing can be difficult. NTT are the essential test for newborns and some degree of laboratory or imaging work up often are needed. Consider consulting an expert in infectious diseases and/or perinatology if the gray areas do not readily become clear. Treatment of the correct patients with the right drug for the right duration remains the goal, as usual.

Dr. Harrison is a professor of pediatrics at University of Missouri-Kansas City and Director of Research Affairs in the pediatric infectious diseases division at Children’s Mercy Hospital – Kansas City. He said he had no relevant financial disclosures. Email him at pdnews@mdedge.com.

References

1. MMWR. 2015 Nov 13;64(44);1241-5.

2. “Congenital Syphilis,” 2015 Sexually Transmitted Diseases Treatment Guidelines.

3. “Syphilis During Pregnancy,” 2015 Sexually Transmitted Diseases Treatment Guidelines.

4. Syphilis – Section 3: Summaries of Infectious Diseases. Red Book Online. 2018.
 

While many pediatric clinicians have not frequently managed newborns of mothers with reactive syphilis serology, increased adult syphilis may change that.¹

Diagnosing/managing congenital syphilis is not always clear cut. A positive rapid plasma reagin (RPR) titer in a newborn may not indicate congenital infection but merely may reflect transplacental, passively acquired maternal IgG from the mother’s current or previous infection rather than antibodies produced by the newborn. Because currently no IgM assay for syphilis is recommended by the Centers for Disease Control and Prevention for newborn testing, we must deal with IgG test results.

Often initial management decisions are needed while the infant’s status is evolving. The questions to answer to make final decisions include the following²:

• Was the mother actively infected with Treponema pallidum during pregnancy?
• If so, was the mother appropriately treated and when?
• Does the infant have any clinical, laboratory, or radiographic evidence of syphilis?
• How do the mother’s and infant’s nontreponemal serologic titers (NTT) compare at delivery using the same test?

Note: All infants assessed for congenital syphilis need a full evaluation for HIV.
 

Managing the infant of a mother with positive tests^3,4

All such neonates need an examination for evidence of congenital syphilis. The clinical signs of congenital syphilis in neonates include nonimmune hydrops, jaundice, hepatosplenomegaly, rhinitis, skin rash, and pseudoparalysis of extremity. Also, consider dark-field examination or polymerase chain reaction (PCR) of lesions (such as bullae) or secretions (nasal). If available, have the placenta examined histologically (silver stain) or by PCR (Clinical Laboratory Improvement Amendments–validated test). Skeletal radiographic surveys are more useful for stillborn than live born infants. (The complete algorithm can be found in Figure 3.10 of reference 4.)

Order a quantitative NTT, using the Venereal Disease Research Laboratory (VDRL) test or RPR test on neonatal serum. Umbilical cord blood is not appropriate because of potential maternal blood contamination, which could give a false-positive result, or Wharton’s jelly, which could give a false-negative result. Use of treponemal-specific tests that are used for maternal diagnosis – such as T. pallidum particle agglutination (TP-PA), T. pallidum enzyme-linked immunosorbent assay (TP-EIA), fluorescent treponemal antibody absorption (FTA-ABS) test, or T. pallidum chemiluminescence immunoassay (TP-CIA) – on neonatal serum is not recommended because of difficulties in interpretation.

Diagnostic results allow designation of an infant into one of four CDC categories: proven/highly probable syphilis; possible syphilis; syphilis less likely; and syphilis unlikely. Treatment recommendations are based on these categories.

Proven or highly probable syphilis

There are two alternative recommended 10-day treatment regimens.

A. Aqueous crystalline penicillin G 100,000-150,000 U/kg per day by IV at 50,000 U/kg per dose, given every 12 hours through 7 days of age or every 8 hours if greater than 7 days old.

B. Procaine penicillin G at 50,000 U/kg per dose intramuscularly in one dose each day.

More than 1 day of missed therapy requires restarting a new 10-day course. Use of other antimicrobial agents (such as ampicillin) is not validated, so any empiric ampicillin initially given for possible sepsis does not count toward the 10-day penicillin regimen. If nonpenicillin drugs must be used, close serologic follow-up must occur to ensure adequacy of response to therapy.
 

Possible syphilis

There are three alternative regimens, the same two as in proven/highly probable syphilis (above) plus a single-dose option

A. Aqueous crystalline penicillin G, as described above.

B. Procaine penicillin G, as described above.

C. Benzathine penicillin G at 50,000 U/kg per dose intramuscularly in a single dose.

Note: To be eligible for regimen C, an infant must have a complete evaluation that is normal (cerebrospinal fluid [CSF] examination, long-bone radiographs, and complete blood count with platelet count) and follow-up must be assured. Exception: Neonates born to mothers with untreated early syphilis at the time of delivery are at increased risk for congenital syphilis, and the 10-day course of penicillin G may be considered even if the complete evaluation is normal and follow-up is certain.
 

Less likely syphilis

One antibiotic regimen is available, but no treatment also may be an option.

A. Benzathine penicillin G as described above.

B. If mother’s NTT has decreased at least fourfold after appropriate early syphilis therapy or remained stably low, which indicates latent syphilis (VDRL less than 1:2; RPR less than 1:4), no treatment is an option but requires repeat serology every 2-3 months until infant is 6 months old.

Unlikely syphilis

No treatment is recommended unless follow-up is uncertain, in which case it is appropriate to give the infant benzathine penicillin G as described above.

Infant with positive NTT at birth

All neonates with reactive NTT need careful follow-up examinations and repeat NTT every 2-3 months until nonreactive. NTT in infants who are not treated because of less likely or unlikely syphilis status should drop by 3 months and be nonreactive by 6 months; this indicates NTT was passively transferred maternal IgG. If NTT remains reactive at 6 months, the infant is likely infected and needs treatment. Persistent NTT at 6-12 months in treated neonates should trigger repeat CSF examination and infectious diseases consultation about a possible repeat of the 10-day penicillin G regimen. If the mother was seroreactive, but the newborn’s NTT was negative at birth, testing of the infant’s NTT needs repeating at 3 months to exclude the possibility that the congenital syphilis was incubating when prior testing occurred at birth. Note: Treponemal-specific tests are not useful in assessing treatment because detectable maternal IgG treponemal antibody can persist at least 15 months.

Neonates with abnormal CSF at birth

Repeat cerebrospinal fluid evaluation every 6 months until results normalize. Persistently reactive CSF VDRL or abnormal CSF indexes not caused by another known cause requires retreatment for possible neurosyphilis, as well as consultation with an expert.

Summary

Decisions on managing infants of mothers with positive syphilis testing can be difficult. NTT are the essential test for newborns and some degree of laboratory or imaging work up often are needed. Consider consulting an expert in infectious diseases and/or perinatology if the gray areas do not readily become clear. Treatment of the correct patients with the right drug for the right duration remains the goal, as usual.

Dr. Harrison is a professor of pediatrics at University of Missouri-Kansas City and Director of Research Affairs in the pediatric infectious diseases division at Children’s Mercy Hospital – Kansas City. He said he had no relevant financial disclosures. Email him at pdnews@mdedge.com.

References

1. MMWR. 2015 Nov 13;64(44);1241-5.

2. “Congenital Syphilis,” 2015 Sexually Transmitted Diseases Treatment Guidelines.

3. “Syphilis During Pregnancy,” 2015 Sexually Transmitted Diseases Treatment Guidelines.

4. Syphilis – Section 3: Summaries of Infectious Diseases. Red Book Online. 2018.
 

Photo by Bill Branson

The thrombopoietin receptor agonist romiplostim (NPlate®) is now approved by the U.S. Food and Drug Administration (FDA) to treat pediatric patients 1 year and older who have had immune thrombocytopenia (ITP) for at least 6 months and have not responded sufficiently to corticosteroids, immunoglobulins, or splenectomy.

Romiplostim was originally FDA-approved in 2008 to treat adult patients with chronic ITP who had an insufficient response to the same treatments.

Romiplostim is manufactured by Amgen, Inc.

The FDA based its approval on two double-blind, placebo-controlled clinical trials.

NCT01444417

The phase 3 study (NCT01444417) enrolled 62 pediatric patients 1 year and older who had ITP for at least 6 months. They were refractory to or relapsed after at least one prior therapy.

Investigators randomized them 2:1 to receive romiplostim (n=42) or placebo (n=20).

The starting dose was 1 μg/kg weekly for all ages. The dose was titrated up over a 24-week period to a maximum of 10 μg/kg weekly.

Patients were a median age of 9.5 years (range, 3–17), and 57% were female. A little over half (58%) had baseline platelet counts of 20 x 10⁹/L or less, which was similar in both treatment arms.

Eighty-one percent of romiplostim-treated patients had at least two prior ITP therapies, compared with 70% in the placebo group. One patient in each group had undergone splenectomy.

Twenty-two (52%) of the romiplostim-treated patients had durable platelet responses of 50 x 10⁹/L or greater for at least six weekly assessments during weeks 18 through 25 of treatment. Two (10%) patients in the placebo arm achieved durable platelet responses.

Thirty (71%) romiplostim-treated patients achieved an overall platelet response, defined as a durable or transient platelet response. This compared with four (20%) patients in the placebo group.

Romiplostim-treated patients had platelet counts of at least 50 x 10⁹/L for a median of 12 weeks, compared to 1 week for patients in the placebo arm.

All response endpoints were significant at P<0.05.

NCT00515203

The phase 1/2 study (NCT00515203) enrolled 22 patients who had ITP for at least 6 months prior to study enrollment and were relapsed from or refractory to prior treatment.

Investigators randomized the patients 3:1 to romiplostim (n=17) or placebo (n=5).

Patients were a median age of 10 years (range, 1–17), and 27.3% were female.

Approximately 82% of patients had baseline platelet counts of 20 x 10⁹/L or less, which was similar between the treatment arms.

Eighty-eight percent of patients in the romiplostim arm had at least two prior ITP therapies, as did 100% in the placebo group.

Six patients in the romiplostim group and two in the placebo group had undergone splenectomy.

Of the 17 patients treated with romiplostim, 15 (88.2%) achieved a platelet count of 50 x 10⁹/L or great for 2 consecutive weeks.

The same 15 patients also achieved an increase in platelet count of 20 x 10⁹/L or greater above baseline for 2 consecutive weeks during the treatment period.

None of the placebo-treated patients achieved either endpoint.

The adverse events profile in pediatric patients was compiled from the two trials and reflects a median drug exposure of 168 days for 59 patients.

The most common adverse events, occurring in 25% or more of romiplostim-treated patients, were contusion (41%), upper respiratory tract infection (31%), and oropharyngeal pain (25%). These occurred with an incidence at least 5% higher than in the placebo group.

Dosing

The recommended starting dose for pediatric patients is 1 µg/kg based on actual body weight and administered as a weekly subcutaneous injection.

The dose should be adjusted in increments of 1 µg/kg until the patient achieves a platelet count of 50 x 10⁹/L or greater.

The prescribing information recommends reassessing patients’ body weight every 12 weeks. 

Photo by Bill Branson

The thrombopoietin receptor agonist romiplostim (NPlate®) is now approved by the U.S. Food and Drug Administration (FDA) to treat pediatric patients 1 year and older who have had immune thrombocytopenia (ITP) for at least 6 months and have not responded sufficiently to corticosteroids, immunoglobulins, or splenectomy.

Romiplostim was originally FDA-approved in 2008 to treat adult patients with chronic ITP who had an insufficient response to the same treatments.

Romiplostim is manufactured by Amgen, Inc.

The FDA based its approval on two double-blind, placebo-controlled clinical trials.

NCT01444417

The phase 3 study (NCT01444417) enrolled 62 pediatric patients 1 year and older who had ITP for at least 6 months. They were refractory to or relapsed after at least one prior therapy.

Investigators randomized them 2:1 to receive romiplostim (n=42) or placebo (n=20).

The starting dose was 1 μg/kg weekly for all ages. The dose was titrated up over a 24-week period to a maximum of 10 μg/kg weekly.

Patients were a median age of 9.5 years (range, 3–17), and 57% were female. A little over half (58%) had baseline platelet counts of 20 x 10⁹/L or less, which was similar in both treatment arms.

Eighty-one percent of romiplostim-treated patients had at least two prior ITP therapies, compared with 70% in the placebo group. One patient in each group had undergone splenectomy.

Twenty-two (52%) of the romiplostim-treated patients had durable platelet responses of 50 x 10⁹/L or greater for at least six weekly assessments during weeks 18 through 25 of treatment. Two (10%) patients in the placebo arm achieved durable platelet responses.

Thirty (71%) romiplostim-treated patients achieved an overall platelet response, defined as a durable or transient platelet response. This compared with four (20%) patients in the placebo group.

Romiplostim-treated patients had platelet counts of at least 50 x 10⁹/L for a median of 12 weeks, compared to 1 week for patients in the placebo arm.

All response endpoints were significant at P<0.05.

NCT00515203

The phase 1/2 study (NCT00515203) enrolled 22 patients who had ITP for at least 6 months prior to study enrollment and were relapsed from or refractory to prior treatment.

Investigators randomized the patients 3:1 to romiplostim (n=17) or placebo (n=5).

Patients were a median age of 10 years (range, 1–17), and 27.3% were female.

Approximately 82% of patients had baseline platelet counts of 20 x 10⁹/L or less, which was similar between the treatment arms.

Eighty-eight percent of patients in the romiplostim arm had at least two prior ITP therapies, as did 100% in the placebo group.

Six patients in the romiplostim group and two in the placebo group had undergone splenectomy.

Of the 17 patients treated with romiplostim, 15 (88.2%) achieved a platelet count of 50 x 10⁹/L or great for 2 consecutive weeks.

The same 15 patients also achieved an increase in platelet count of 20 x 10⁹/L or greater above baseline for 2 consecutive weeks during the treatment period.

None of the placebo-treated patients achieved either endpoint.

The adverse events profile in pediatric patients was compiled from the two trials and reflects a median drug exposure of 168 days for 59 patients.

The most common adverse events, occurring in 25% or more of romiplostim-treated patients, were contusion (41%), upper respiratory tract infection (31%), and oropharyngeal pain (25%). These occurred with an incidence at least 5% higher than in the placebo group.

Dosing

The recommended starting dose for pediatric patients is 1 µg/kg based on actual body weight and administered as a weekly subcutaneous injection.

The dose should be adjusted in increments of 1 µg/kg until the patient achieves a platelet count of 50 x 10⁹/L or greater.

The prescribing information recommends reassessing patients’ body weight every 12 weeks. 

Photo by Bill Branson

The thrombopoietin receptor agonist romiplostim (NPlate®) is now approved by the U.S. Food and Drug Administration (FDA) to treat pediatric patients 1 year and older who have had immune thrombocytopenia (ITP) for at least 6 months and have not responded sufficiently to corticosteroids, immunoglobulins, or splenectomy.

Romiplostim was originally FDA-approved in 2008 to treat adult patients with chronic ITP who had an insufficient response to the same treatments.

Romiplostim is manufactured by Amgen, Inc.

The FDA based its approval on two double-blind, placebo-controlled clinical trials.

NCT01444417

The phase 3 study (NCT01444417) enrolled 62 pediatric patients 1 year and older who had ITP for at least 6 months. They were refractory to or relapsed after at least one prior therapy.

Investigators randomized them 2:1 to receive romiplostim (n=42) or placebo (n=20).

The starting dose was 1 μg/kg weekly for all ages. The dose was titrated up over a 24-week period to a maximum of 10 μg/kg weekly.

Patients were a median age of 9.5 years (range, 3–17), and 57% were female. A little over half (58%) had baseline platelet counts of 20 x 10⁹/L or less, which was similar in both treatment arms.

Eighty-one percent of romiplostim-treated patients had at least two prior ITP therapies, compared with 70% in the placebo group. One patient in each group had undergone splenectomy.

Twenty-two (52%) of the romiplostim-treated patients had durable platelet responses of 50 x 10⁹/L or greater for at least six weekly assessments during weeks 18 through 25 of treatment. Two (10%) patients in the placebo arm achieved durable platelet responses.

Thirty (71%) romiplostim-treated patients achieved an overall platelet response, defined as a durable or transient platelet response. This compared with four (20%) patients in the placebo group.

Romiplostim-treated patients had platelet counts of at least 50 x 10⁹/L for a median of 12 weeks, compared to 1 week for patients in the placebo arm.

All response endpoints were significant at P<0.05.

NCT00515203

The phase 1/2 study (NCT00515203) enrolled 22 patients who had ITP for at least 6 months prior to study enrollment and were relapsed from or refractory to prior treatment.

Investigators randomized the patients 3:1 to romiplostim (n=17) or placebo (n=5).

Patients were a median age of 10 years (range, 1–17), and 27.3% were female.

Approximately 82% of patients had baseline platelet counts of 20 x 10⁹/L or less, which was similar between the treatment arms.

Eighty-eight percent of patients in the romiplostim arm had at least two prior ITP therapies, as did 100% in the placebo group.

Six patients in the romiplostim group and two in the placebo group had undergone splenectomy.

Of the 17 patients treated with romiplostim, 15 (88.2%) achieved a platelet count of 50 x 10⁹/L or great for 2 consecutive weeks.

The same 15 patients also achieved an increase in platelet count of 20 x 10⁹/L or greater above baseline for 2 consecutive weeks during the treatment period.

None of the placebo-treated patients achieved either endpoint.

The adverse events profile in pediatric patients was compiled from the two trials and reflects a median drug exposure of 168 days for 59 patients.

The most common adverse events, occurring in 25% or more of romiplostim-treated patients, were contusion (41%), upper respiratory tract infection (31%), and oropharyngeal pain (25%). These occurred with an incidence at least 5% higher than in the placebo group.

Dosing

The recommended starting dose for pediatric patients is 1 µg/kg based on actual body weight and administered as a weekly subcutaneous injection.

The dose should be adjusted in increments of 1 µg/kg until the patient achieves a platelet count of 50 x 10⁹/L or greater.

The prescribing information recommends reassessing patients’ body weight every 12 weeks. 

The effectiveness of the influenza vaccine declined significantly after 9 months, according to 5 years of data from approximately 15,000 children in Hong Kong.

CAP53/iStockphoto.com

The vaccine is known to last less than a year, but the findings support the need for more vaccine availability in areas where influenza activity occurs year-round, wrote Shuo Feng, PhD, and Susan S. Chiu, MD, of the University of Hong Kong, and their colleagues.

In a study published in the Lancet Respiratory Medicine, the researchers reviewed how vaccine effectiveness changed over time by analyzing data from children aged 6 months to 17 years admitted to a Hong Kong hospital between 2012 and 2017. The study population involved 15,695 children hospitalized for respiratory infections, including 2,500 who were positive for influenza A or B and 13,195 who were negative. Of these, 6.4% of the positive patients and 11% of the negative patients had been vaccinated; 70% to 80% of the vaccinations occurred before the end of December of a given year.

Overall, the vaccination effectiveness rate was 79% for 0.5 to 2 months after vaccination, then dropped to 60% at 2-4 months, 57% at 4-6 months, and 45% at 6-9 months.

The researchers estimated vaccine effectiveness by three time periods: September to December, January to April, and May to August. Across seasons, vaccine effectiveness for all age groups was 79% for September to December, 67% for January to April, and 43% for May to August.

The study results were strengthened by the inclusion of year-round activity, but limited by several factors including lack of data on patients’ vaccination history and the specifics of each year’s flu virus, and lack of generalizability to an adult population, the researchers said.

However, the findings support data from previous studies on the effectiveness of annual vaccination, with the optimal timing from October to December in Hong Kong, they said. “Improved influenza vaccines are needed to provide year-round protection for children, particularly in subtropical and tropical locations,” they added.

The study was supported by the Health and Medical Research Fund and the Research Grants Council, Hong Kong. The lead authors had no financial conflicts to disclose.

SOURCE: Feng S et al. Lancet Respir Med. 2018;6:925-34.

The effectiveness of the influenza vaccine declined significantly after 9 months, according to 5 years of data from approximately 15,000 children in Hong Kong.

CAP53/iStockphoto.com

The vaccine is known to last less than a year, but the findings support the need for more vaccine availability in areas where influenza activity occurs year-round, wrote Shuo Feng, PhD, and Susan S. Chiu, MD, of the University of Hong Kong, and their colleagues.

In a study published in the Lancet Respiratory Medicine, the researchers reviewed how vaccine effectiveness changed over time by analyzing data from children aged 6 months to 17 years admitted to a Hong Kong hospital between 2012 and 2017. The study population involved 15,695 children hospitalized for respiratory infections, including 2,500 who were positive for influenza A or B and 13,195 who were negative. Of these, 6.4% of the positive patients and 11% of the negative patients had been vaccinated; 70% to 80% of the vaccinations occurred before the end of December of a given year.

Overall, the vaccination effectiveness rate was 79% for 0.5 to 2 months after vaccination, then dropped to 60% at 2-4 months, 57% at 4-6 months, and 45% at 6-9 months.

The researchers estimated vaccine effectiveness by three time periods: September to December, January to April, and May to August. Across seasons, vaccine effectiveness for all age groups was 79% for September to December, 67% for January to April, and 43% for May to August.

The study results were strengthened by the inclusion of year-round activity, but limited by several factors including lack of data on patients’ vaccination history and the specifics of each year’s flu virus, and lack of generalizability to an adult population, the researchers said.

However, the findings support data from previous studies on the effectiveness of annual vaccination, with the optimal timing from October to December in Hong Kong, they said. “Improved influenza vaccines are needed to provide year-round protection for children, particularly in subtropical and tropical locations,” they added.

The study was supported by the Health and Medical Research Fund and the Research Grants Council, Hong Kong. The lead authors had no financial conflicts to disclose.

SOURCE: Feng S et al. Lancet Respir Med. 2018;6:925-34.

The effectiveness of the influenza vaccine declined significantly after 9 months, according to 5 years of data from approximately 15,000 children in Hong Kong.

CAP53/iStockphoto.com

The vaccine is known to last less than a year, but the findings support the need for more vaccine availability in areas where influenza activity occurs year-round, wrote Shuo Feng, PhD, and Susan S. Chiu, MD, of the University of Hong Kong, and their colleagues.

In a study published in the Lancet Respiratory Medicine, the researchers reviewed how vaccine effectiveness changed over time by analyzing data from children aged 6 months to 17 years admitted to a Hong Kong hospital between 2012 and 2017. The study population involved 15,695 children hospitalized for respiratory infections, including 2,500 who were positive for influenza A or B and 13,195 who were negative. Of these, 6.4% of the positive patients and 11% of the negative patients had been vaccinated; 70% to 80% of the vaccinations occurred before the end of December of a given year.

Overall, the vaccination effectiveness rate was 79% for 0.5 to 2 months after vaccination, then dropped to 60% at 2-4 months, 57% at 4-6 months, and 45% at 6-9 months.

The researchers estimated vaccine effectiveness by three time periods: September to December, January to April, and May to August. Across seasons, vaccine effectiveness for all age groups was 79% for September to December, 67% for January to April, and 43% for May to August.

The study results were strengthened by the inclusion of year-round activity, but limited by several factors including lack of data on patients’ vaccination history and the specifics of each year’s flu virus, and lack of generalizability to an adult population, the researchers said.

However, the findings support data from previous studies on the effectiveness of annual vaccination, with the optimal timing from October to December in Hong Kong, they said. “Improved influenza vaccines are needed to provide year-round protection for children, particularly in subtropical and tropical locations,” they added.

The study was supported by the Health and Medical Research Fund and the Research Grants Council, Hong Kong. The lead authors had no financial conflicts to disclose.

SOURCE: Feng S et al. Lancet Respir Med. 2018;6:925-34.

Photo by Rod Waddington

SAN DIEGO—An inexpensive, rapid, and easy-to-use blood test accurately detected sickle cell disease in young children in Uganda, according to a speaker at the 2018 ASH Annual Meeting.

The test, called HemoTypeSC, uses monoclonal antibodies to detect hemoglobins A, S, and C in a drop of whole blood.

HemoTypeSC costs less than $2 to the end user and delivers results in about 10 minutes.

“This is ideal for use in resource-constrained regions of high prevalence, such as Africa and central India,” said Erik Serrao, PhD, of Silver Lake Research in Azusa, California.

“Early screening plus treatment plus counseling equals saving millions of lives over the coming decades, and we believe HemoTypeSC can form an integral part of the initial part of this equation.”

Dr. Serrao reported results from a study of HemoTypeSC during the late-breaking abstracts session at ASH (abstract LBA-3).

He and his colleagues compared results with the HemoTypeSC test to results with hemoglobin electrophoresis for detection of the phenotypes HbAA (normal), HbAS (sickle cell trait), and HbSS (sickle cell disease).

The investigators compared these two testing methods in 1,000 children between the ages of 1 month and 5 years who were prospectively recruited from hospital wards and outpatient clinics in Uganda.

Results

The initial analysis suggested HemoTypeSC had an overall accuracy of 99.8%, correctly identifying 998 of 1,000 phenotypes as initially determined by electrophoresis.

HemoTypeSC correctly identified 100% of the 720 HbAA specimens and 100% of 182 HbAS specimens.

HemoTypeSC identified as HbSS 98% (96/98) of specimens that were identified as HbSS by electrophoresis. This left two discordant samples, both of which HemoTypeSC identified as HbAS.

Investigators subsequently discovered that both individuals with the discordant samples had previously been diagnosed with sickle cell disease and had received recent transfusions with HbAA blood.

“Therefore, the true phenotype at the time of testing for these samples was HbAS, as hemoglobin A and S were both in the blood,” Dr. Serrao said.

This brought the accuracy rate of HemoTypeSC up to 100%.

Dr. Serrao noted that this study excluded newborns. However, a different study of HemoTypeSC, recently published in the American Journal of Hematology, demonstrated 100% accuracy across multiple phenotypes in the setting of newborn screening.

Implications

Of all the late-breaking abstracts at ASH this year, the study by Dr. Serrao and his colleagues is the one with the potential to save the most lives, according to Mark Crowther, MD, of McMaster University in Hamilton, Ontario, Canada.

He said using current gold-standard methods for diagnosing sickle cell disease is, at minimum, challenging and “frankly impossible” in many low-resource settings because of the cost and the requirement for sophisticated equipment and reliable electricity.

However, he believes HemoTypeSC could change that.

“The ability to diagnose sickle cell disease early and intervene early will result in potentially thousands of infants, who would otherwise die in infancy or early childhood, surviving into adulthood,” Dr. Crowther said.

Dr. Serrao noted that sickle cell disease screening programs have been projected to be cost-effective in Africa. Such programs could even save money for governments over time as budgets are reallocated toward screening, with less money needed for treatment of patients presenting with severe complications in hospitals.

Dr. Serrao reported that he is an employee of Silver Lake Research, which funded this study, approved the study design, and donated HemoTypeSC tests.

Photo by Rod Waddington

SAN DIEGO—An inexpensive, rapid, and easy-to-use blood test accurately detected sickle cell disease in young children in Uganda, according to a speaker at the 2018 ASH Annual Meeting.

The test, called HemoTypeSC, uses monoclonal antibodies to detect hemoglobins A, S, and C in a drop of whole blood.

HemoTypeSC costs less than $2 to the end user and delivers results in about 10 minutes.

“This is ideal for use in resource-constrained regions of high prevalence, such as Africa and central India,” said Erik Serrao, PhD, of Silver Lake Research in Azusa, California.

“Early screening plus treatment plus counseling equals saving millions of lives over the coming decades, and we believe HemoTypeSC can form an integral part of the initial part of this equation.”

Dr. Serrao reported results from a study of HemoTypeSC during the late-breaking abstracts session at ASH (abstract LBA-3).

He and his colleagues compared results with the HemoTypeSC test to results with hemoglobin electrophoresis for detection of the phenotypes HbAA (normal), HbAS (sickle cell trait), and HbSS (sickle cell disease).

The investigators compared these two testing methods in 1,000 children between the ages of 1 month and 5 years who were prospectively recruited from hospital wards and outpatient clinics in Uganda.

Results

The initial analysis suggested HemoTypeSC had an overall accuracy of 99.8%, correctly identifying 998 of 1,000 phenotypes as initially determined by electrophoresis.

HemoTypeSC correctly identified 100% of the 720 HbAA specimens and 100% of 182 HbAS specimens.

HemoTypeSC identified as HbSS 98% (96/98) of specimens that were identified as HbSS by electrophoresis. This left two discordant samples, both of which HemoTypeSC identified as HbAS.

Investigators subsequently discovered that both individuals with the discordant samples had previously been diagnosed with sickle cell disease and had received recent transfusions with HbAA blood.

“Therefore, the true phenotype at the time of testing for these samples was HbAS, as hemoglobin A and S were both in the blood,” Dr. Serrao said.

This brought the accuracy rate of HemoTypeSC up to 100%.

Dr. Serrao noted that this study excluded newborns. However, a different study of HemoTypeSC, recently published in the American Journal of Hematology, demonstrated 100% accuracy across multiple phenotypes in the setting of newborn screening.

Implications

Of all the late-breaking abstracts at ASH this year, the study by Dr. Serrao and his colleagues is the one with the potential to save the most lives, according to Mark Crowther, MD, of McMaster University in Hamilton, Ontario, Canada.

He said using current gold-standard methods for diagnosing sickle cell disease is, at minimum, challenging and “frankly impossible” in many low-resource settings because of the cost and the requirement for sophisticated equipment and reliable electricity.

However, he believes HemoTypeSC could change that.

“The ability to diagnose sickle cell disease early and intervene early will result in potentially thousands of infants, who would otherwise die in infancy or early childhood, surviving into adulthood,” Dr. Crowther said.

Dr. Serrao noted that sickle cell disease screening programs have been projected to be cost-effective in Africa. Such programs could even save money for governments over time as budgets are reallocated toward screening, with less money needed for treatment of patients presenting with severe complications in hospitals.

Dr. Serrao reported that he is an employee of Silver Lake Research, which funded this study, approved the study design, and donated HemoTypeSC tests.

Photo by Rod Waddington

SAN DIEGO—An inexpensive, rapid, and easy-to-use blood test accurately detected sickle cell disease in young children in Uganda, according to a speaker at the 2018 ASH Annual Meeting.

The test, called HemoTypeSC, uses monoclonal antibodies to detect hemoglobins A, S, and C in a drop of whole blood.

HemoTypeSC costs less than $2 to the end user and delivers results in about 10 minutes.

“This is ideal for use in resource-constrained regions of high prevalence, such as Africa and central India,” said Erik Serrao, PhD, of Silver Lake Research in Azusa, California.

“Early screening plus treatment plus counseling equals saving millions of lives over the coming decades, and we believe HemoTypeSC can form an integral part of the initial part of this equation.”

Dr. Serrao reported results from a study of HemoTypeSC during the late-breaking abstracts session at ASH (abstract LBA-3).

He and his colleagues compared results with the HemoTypeSC test to results with hemoglobin electrophoresis for detection of the phenotypes HbAA (normal), HbAS (sickle cell trait), and HbSS (sickle cell disease).

The investigators compared these two testing methods in 1,000 children between the ages of 1 month and 5 years who were prospectively recruited from hospital wards and outpatient clinics in Uganda.

Results

The initial analysis suggested HemoTypeSC had an overall accuracy of 99.8%, correctly identifying 998 of 1,000 phenotypes as initially determined by electrophoresis.

HemoTypeSC correctly identified 100% of the 720 HbAA specimens and 100% of 182 HbAS specimens.

HemoTypeSC identified as HbSS 98% (96/98) of specimens that were identified as HbSS by electrophoresis. This left two discordant samples, both of which HemoTypeSC identified as HbAS.

Investigators subsequently discovered that both individuals with the discordant samples had previously been diagnosed with sickle cell disease and had received recent transfusions with HbAA blood.

“Therefore, the true phenotype at the time of testing for these samples was HbAS, as hemoglobin A and S were both in the blood,” Dr. Serrao said.

This brought the accuracy rate of HemoTypeSC up to 100%.

Dr. Serrao noted that this study excluded newborns. However, a different study of HemoTypeSC, recently published in the American Journal of Hematology, demonstrated 100% accuracy across multiple phenotypes in the setting of newborn screening.

Implications

Of all the late-breaking abstracts at ASH this year, the study by Dr. Serrao and his colleagues is the one with the potential to save the most lives, according to Mark Crowther, MD, of McMaster University in Hamilton, Ontario, Canada.

He said using current gold-standard methods for diagnosing sickle cell disease is, at minimum, challenging and “frankly impossible” in many low-resource settings because of the cost and the requirement for sophisticated equipment and reliable electricity.

However, he believes HemoTypeSC could change that.

“The ability to diagnose sickle cell disease early and intervene early will result in potentially thousands of infants, who would otherwise die in infancy or early childhood, surviving into adulthood,” Dr. Crowther said.

Dr. Serrao noted that sickle cell disease screening programs have been projected to be cost-effective in Africa. Such programs could even save money for governments over time as budgets are reallocated toward screening, with less money needed for treatment of patients presenting with severe complications in hospitals.

Dr. Serrao reported that he is an employee of Silver Lake Research, which funded this study, approved the study design, and donated HemoTypeSC tests.

PARIS – A major worldwide survey of the 12-month prevalence of atopic dermatitis (AD) across the course of life provides new insights into global disease trends, Jonathan I. Silverberg, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Among the most important takeaways from this Internet-based survey of more than 273,645 infants, children, and adults in 18 countries across five continents conducted in 2017 was that “global atopic dermatitis prevalence appears to be higher in adults, at 10%, than in younger cohorts, where it’s 4%-8%, which I think is quite provocative and requires further study and confirmation,” said Dr. Silverberg, a dermatologist at Northwestern University in Chicago.

“Let’s keep in mind that there’s this accepted dogma in the literature than atopic dermatitis is somehow only a childhood disorder – it doesn’t affect adults. Well, these data tell a very different story because we’re actually seeing overall highest prevalences throughout the world occurring in adulthood,” based on the U.K. Working Party’s Diagnostic Criteria for Atopic Dermatitis (Br J Dermatol. 1994 Sep;131[3]:383-96).

This is the biggest epidemiologic survey ever to examine the 12-month prevalence and severity of AD around the world for both adults and children. Survey respondents included 172,627 adults aged 18 years and older, 34,212 adolescents aged 12-17 years, 54,806 children aged 2-11 years, and more than 12,000 infants.

Key findings from the study include the following:

• AD prevalence rates varied widely from country to country around the world, as well as by age groups (see graphic).
• The highest rate in adults was observed in China. South Korea had the highest rates in both children and adolescents. The top AD rates in infancy occurred in France and the United Kingdom.
• Rates across the age spectrum were consistently lowest in Israel and Switzerland.

“These kinds of patterns raise fascinating questions about the potential risk factors or protective factors that happen in different countries. There are some startling differences in terms of the different regions,” Dr. Silverberg observed. “Certain regions of the world really stand out as having much higher prevalences, particularly China and South Korea, and then as you get into the adult years, Brazil and Mexico, which I think are areas that, at least in the global atopic dermatitis epidemiology community, are not quite as well recognized as being hot spots for atopic dermatitis.”

Indeed, the 12-month prevalence rate of AD among adults was 14% in Mexico and 12% in Brazil, as compared with 13% in Saudi Arabia, 11% in Australia and Spain, 10% in Canada and the United Kingdom, and 9% in the United States.

The prevalence was generally lowest in infants, then jumped substantially within countries during the childhood years, declined slightly in adolescents, and then peaked in adulthood.

AD severity was assessed using PO-SCORAD, the Patient-Oriented Scoring AD measure. Most affected individuals had moderate AD as defined by a PO-SCORAD score of 25-50. Across the age spectrum, the highest proportion of infants with AD who had moderate disease was in China, with 72%. In Taiwan, 63% of children with AD had moderate disease, as did 68% of adolescents and an equal proportion of adults.

In the United Kingdom, 49% percent of infants with AD had severe disease, making that country the world leader in the youngest age group. Severe AD was most common among Turkish children, where 30% of kids with the skin disease had a PO-SCORAD score greater than 50. In Brazil, 31% of adolescents with AD had severe disease, the world’s highest rate in that age group. Among adults with AD, the world’s highest rate of severe disease was 25%, which was seen in the United States, Brazil, and Saudi Arabia.

Across the age spectrum, Japan had a consistently lower-end, overall, 12-month AD prevalence rate of 5%. Germany, Italy, and France had overall rates of 6%, 7%, and 8%, respectively. The rate was 9% in the United States and Canada, and it was 10% in Australia.

Dr. Silverberg performed validation analyses using the Patient-Oriented Eczema Measure (POEM) and diagnostic criteria similar to the earlier landmark International Study of Asthma and Allergies in Childhood, or ISAAC (Lancet. 1998 Apr 25;351[9111]:1225-32). This was a huge study that excluded the United States, leaving a hole in the epidemiologic picture of the disease that the new survey fills. The validation analyses were supportive of the main findings based on the U.K. Working Party criteria.

Dr. Silverberg reported serving as a consultant to Pfizer, which sponsored the global epidemiologic survey, as well as to roughly a dozen other pharmaceutical companies.

bjancin@mdedge.com

SOURCE: Silverberg JI. EADV Congress, Abstract FC01.01.

PARIS – A major worldwide survey of the 12-month prevalence of atopic dermatitis (AD) across the course of life provides new insights into global disease trends, Jonathan I. Silverberg, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Among the most important takeaways from this Internet-based survey of more than 273,645 infants, children, and adults in 18 countries across five continents conducted in 2017 was that “global atopic dermatitis prevalence appears to be higher in adults, at 10%, than in younger cohorts, where it’s 4%-8%, which I think is quite provocative and requires further study and confirmation,” said Dr. Silverberg, a dermatologist at Northwestern University in Chicago.

“Let’s keep in mind that there’s this accepted dogma in the literature than atopic dermatitis is somehow only a childhood disorder – it doesn’t affect adults. Well, these data tell a very different story because we’re actually seeing overall highest prevalences throughout the world occurring in adulthood,” based on the U.K. Working Party’s Diagnostic Criteria for Atopic Dermatitis (Br J Dermatol. 1994 Sep;131[3]:383-96).

This is the biggest epidemiologic survey ever to examine the 12-month prevalence and severity of AD around the world for both adults and children. Survey respondents included 172,627 adults aged 18 years and older, 34,212 adolescents aged 12-17 years, 54,806 children aged 2-11 years, and more than 12,000 infants.

Key findings from the study include the following:

• AD prevalence rates varied widely from country to country around the world, as well as by age groups (see graphic).
• The highest rate in adults was observed in China. South Korea had the highest rates in both children and adolescents. The top AD rates in infancy occurred in France and the United Kingdom.
• Rates across the age spectrum were consistently lowest in Israel and Switzerland.

“These kinds of patterns raise fascinating questions about the potential risk factors or protective factors that happen in different countries. There are some startling differences in terms of the different regions,” Dr. Silverberg observed. “Certain regions of the world really stand out as having much higher prevalences, particularly China and South Korea, and then as you get into the adult years, Brazil and Mexico, which I think are areas that, at least in the global atopic dermatitis epidemiology community, are not quite as well recognized as being hot spots for atopic dermatitis.”

Indeed, the 12-month prevalence rate of AD among adults was 14% in Mexico and 12% in Brazil, as compared with 13% in Saudi Arabia, 11% in Australia and Spain, 10% in Canada and the United Kingdom, and 9% in the United States.

The prevalence was generally lowest in infants, then jumped substantially within countries during the childhood years, declined slightly in adolescents, and then peaked in adulthood.

AD severity was assessed using PO-SCORAD, the Patient-Oriented Scoring AD measure. Most affected individuals had moderate AD as defined by a PO-SCORAD score of 25-50. Across the age spectrum, the highest proportion of infants with AD who had moderate disease was in China, with 72%. In Taiwan, 63% of children with AD had moderate disease, as did 68% of adolescents and an equal proportion of adults.

In the United Kingdom, 49% percent of infants with AD had severe disease, making that country the world leader in the youngest age group. Severe AD was most common among Turkish children, where 30% of kids with the skin disease had a PO-SCORAD score greater than 50. In Brazil, 31% of adolescents with AD had severe disease, the world’s highest rate in that age group. Among adults with AD, the world’s highest rate of severe disease was 25%, which was seen in the United States, Brazil, and Saudi Arabia.

Across the age spectrum, Japan had a consistently lower-end, overall, 12-month AD prevalence rate of 5%. Germany, Italy, and France had overall rates of 6%, 7%, and 8%, respectively. The rate was 9% in the United States and Canada, and it was 10% in Australia.

Dr. Silverberg performed validation analyses using the Patient-Oriented Eczema Measure (POEM) and diagnostic criteria similar to the earlier landmark International Study of Asthma and Allergies in Childhood, or ISAAC (Lancet. 1998 Apr 25;351[9111]:1225-32). This was a huge study that excluded the United States, leaving a hole in the epidemiologic picture of the disease that the new survey fills. The validation analyses were supportive of the main findings based on the U.K. Working Party criteria.

Dr. Silverberg reported serving as a consultant to Pfizer, which sponsored the global epidemiologic survey, as well as to roughly a dozen other pharmaceutical companies.

bjancin@mdedge.com

SOURCE: Silverberg JI. EADV Congress, Abstract FC01.01.

PARIS – A major worldwide survey of the 12-month prevalence of atopic dermatitis (AD) across the course of life provides new insights into global disease trends, Jonathan I. Silverberg, MD, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Among the most important takeaways from this Internet-based survey of more than 273,645 infants, children, and adults in 18 countries across five continents conducted in 2017 was that “global atopic dermatitis prevalence appears to be higher in adults, at 10%, than in younger cohorts, where it’s 4%-8%, which I think is quite provocative and requires further study and confirmation,” said Dr. Silverberg, a dermatologist at Northwestern University in Chicago.

“Let’s keep in mind that there’s this accepted dogma in the literature than atopic dermatitis is somehow only a childhood disorder – it doesn’t affect adults. Well, these data tell a very different story because we’re actually seeing overall highest prevalences throughout the world occurring in adulthood,” based on the U.K. Working Party’s Diagnostic Criteria for Atopic Dermatitis (Br J Dermatol. 1994 Sep;131[3]:383-96).

This is the biggest epidemiologic survey ever to examine the 12-month prevalence and severity of AD around the world for both adults and children. Survey respondents included 172,627 adults aged 18 years and older, 34,212 adolescents aged 12-17 years, 54,806 children aged 2-11 years, and more than 12,000 infants.

Key findings from the study include the following:

• AD prevalence rates varied widely from country to country around the world, as well as by age groups (see graphic).
• The highest rate in adults was observed in China. South Korea had the highest rates in both children and adolescents. The top AD rates in infancy occurred in France and the United Kingdom.
• Rates across the age spectrum were consistently lowest in Israel and Switzerland.

“These kinds of patterns raise fascinating questions about the potential risk factors or protective factors that happen in different countries. There are some startling differences in terms of the different regions,” Dr. Silverberg observed. “Certain regions of the world really stand out as having much higher prevalences, particularly China and South Korea, and then as you get into the adult years, Brazil and Mexico, which I think are areas that, at least in the global atopic dermatitis epidemiology community, are not quite as well recognized as being hot spots for atopic dermatitis.”

Indeed, the 12-month prevalence rate of AD among adults was 14% in Mexico and 12% in Brazil, as compared with 13% in Saudi Arabia, 11% in Australia and Spain, 10% in Canada and the United Kingdom, and 9% in the United States.

The prevalence was generally lowest in infants, then jumped substantially within countries during the childhood years, declined slightly in adolescents, and then peaked in adulthood.

AD severity was assessed using PO-SCORAD, the Patient-Oriented Scoring AD measure. Most affected individuals had moderate AD as defined by a PO-SCORAD score of 25-50. Across the age spectrum, the highest proportion of infants with AD who had moderate disease was in China, with 72%. In Taiwan, 63% of children with AD had moderate disease, as did 68% of adolescents and an equal proportion of adults.

In the United Kingdom, 49% percent of infants with AD had severe disease, making that country the world leader in the youngest age group. Severe AD was most common among Turkish children, where 30% of kids with the skin disease had a PO-SCORAD score greater than 50. In Brazil, 31% of adolescents with AD had severe disease, the world’s highest rate in that age group. Among adults with AD, the world’s highest rate of severe disease was 25%, which was seen in the United States, Brazil, and Saudi Arabia.

Across the age spectrum, Japan had a consistently lower-end, overall, 12-month AD prevalence rate of 5%. Germany, Italy, and France had overall rates of 6%, 7%, and 8%, respectively. The rate was 9% in the United States and Canada, and it was 10% in Australia.

Dr. Silverberg performed validation analyses using the Patient-Oriented Eczema Measure (POEM) and diagnostic criteria similar to the earlier landmark International Study of Asthma and Allergies in Childhood, or ISAAC (Lancet. 1998 Apr 25;351[9111]:1225-32). This was a huge study that excluded the United States, leaving a hole in the epidemiologic picture of the disease that the new survey fills. The validation analyses were supportive of the main findings based on the U.K. Working Party criteria.

Dr. Silverberg reported serving as a consultant to Pfizer, which sponsored the global epidemiologic survey, as well as to roughly a dozen other pharmaceutical companies.

bjancin@mdedge.com

SOURCE: Silverberg JI. EADV Congress, Abstract FC01.01.

Patients with tumor necrosis factor inhibitor–induced psoriasis could potentially be switched to a different drug class if they have moderate to severe skin eruption or mild skin eruption with an uncontrolled underlying disease such as inflammatory bowel disease, psoriasis, psoriatic arthritis, or rheumatoid arthritis, according to a new treatment algorithm proposed by researchers from Brigham and Women’s Hospital and Harvard Medical School in Boston.

The researchers outlined the prevalence of tumor necrosis factor–alpha inhibitor (TNFi)-induced psoriasis in a literature review of inflammatory bowel disease (IBD), psoriasis, psoriatic arthritis (PsA), and rheumatoid arthritis (RA) and identified an estimated rate of between 2.3% and 5% in patients with RA and between 1.6% and 2.7% in patients with IBD. Although there have been reports of TNFi-induced psoriasis in patients with psoriasis and PsA, the prevalence is unclear, they wrote in the Journal of Psoriasis and Psoriatic Arthritis.

The authors then created an algorithm to manage and treat TNFi-induced psoriasiform skin eruptions with decisions to continue therapy and “treat through” symptoms, switch to a different anti-TNF therapy, or switch to a different drug class based on severity of symptoms, whether the underlying disease is well controlled, and how patients with those underlying diseases have fared with those specific therapies or agents.

“We’ve shifted gears over the past decade, and we’ve gone from having very few agents and trying to keep patients desperately on one or two agents because we didn’t want to have to give up on them for their other comorbid disease, whether it was Crohn’s, colitis, RA, or whatever it may be,” senior author Joseph Merola, MD, director of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston, said in an interview. “We’re now in an area where we can have an algorithm like this, and we have so many more mechanistic options to move to.”

Dr. Merola, who is board certified in dermatology and rheumatology, said the algorithm is meant to “open a dialogue” with other specialists in different areas and raise awareness of treatments in related but separate fields. For diseases not often seen by more than one specialty, with the exception of psoriasis and PsA, he said that “the idea is to start a dialogue and increase communication between specialists.”

Dr. Merola noted that while the algorithm in many respects is meant to guide a physician in a specialty in appropriate medication decisions, at the same time he hopes that “it opens a dialogue and communication with the other specialty who tends to oversee this particular disease state or class of medicine to really work together to try to find the right drug for the right person.”

For patients with a mild skin eruption and a controlled underlying disease, the algorithm recommends a “treat through” approach by continuing anti-TNF therapy and treating psoriasis symptoms with topical steroids, ultraviolet therapy, methotrexate, cyclosporine, or acitretin, and to consider dapsone in cases of pustular psoriasis. However, the researchers noted that “treat through” studies have reported complete symptom resolution in 26%-41% of patients.

For patients with recalcitrant or worsening TNFi-induced psoriasis or patients with mild skin eruptions with an uncontrolled underlying disease, the researchers proposed considering switching to a different anti-TNF therapy, although studies have shown complete resolution of symptoms in only 5%-37% of patients.

If patients worsen from there, or if they have moderate to-severe skin eruption with uncontrolled underlying disease, they could be considered for switching to a different drug class and treated based on their underlying disease, along with treatment for psoriasis symptoms. This approach has been shown to completely resolve lesions in up to 64% of cases, they said. IBD patients could benefit from ustekinumab, vedolizumab, 6-mercaptopurine, or azathioprine as an alternative to anti-TNF therapy. Those patients with psoriasis should be considered for guselkumab, while ustekinumab, ixekizumab, secukinumab, and apremilast are effective treatments for patients with psoriasis and PsA. Patients with RA could receive treatment with tocilizumab, rituximab, abatacept, and tofacitinib, the authors wrote.

Dr. Merola reported serving as a consultant and/or investigator for Merck Research Laboratories, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Samumed, Celgene, Sanofi Regeneron, GlaxoSmithKline, Almirall, Sun Pharma, Biogen, Pfizer, Incyte, Aclaris, and Leo Pharma.

SOURCE: Li SJ et al. J Psoriasis Psoriatic Arthritis. 2018 Nov 21. doi: 10.1177/2475530318810851.

Patients with tumor necrosis factor inhibitor–induced psoriasis could potentially be switched to a different drug class if they have moderate to severe skin eruption or mild skin eruption with an uncontrolled underlying disease such as inflammatory bowel disease, psoriasis, psoriatic arthritis, or rheumatoid arthritis, according to a new treatment algorithm proposed by researchers from Brigham and Women’s Hospital and Harvard Medical School in Boston.

The researchers outlined the prevalence of tumor necrosis factor–alpha inhibitor (TNFi)-induced psoriasis in a literature review of inflammatory bowel disease (IBD), psoriasis, psoriatic arthritis (PsA), and rheumatoid arthritis (RA) and identified an estimated rate of between 2.3% and 5% in patients with RA and between 1.6% and 2.7% in patients with IBD. Although there have been reports of TNFi-induced psoriasis in patients with psoriasis and PsA, the prevalence is unclear, they wrote in the Journal of Psoriasis and Psoriatic Arthritis.

The authors then created an algorithm to manage and treat TNFi-induced psoriasiform skin eruptions with decisions to continue therapy and “treat through” symptoms, switch to a different anti-TNF therapy, or switch to a different drug class based on severity of symptoms, whether the underlying disease is well controlled, and how patients with those underlying diseases have fared with those specific therapies or agents.

“We’ve shifted gears over the past decade, and we’ve gone from having very few agents and trying to keep patients desperately on one or two agents because we didn’t want to have to give up on them for their other comorbid disease, whether it was Crohn’s, colitis, RA, or whatever it may be,” senior author Joseph Merola, MD, director of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston, said in an interview. “We’re now in an area where we can have an algorithm like this, and we have so many more mechanistic options to move to.”

Dr. Merola, who is board certified in dermatology and rheumatology, said the algorithm is meant to “open a dialogue” with other specialists in different areas and raise awareness of treatments in related but separate fields. For diseases not often seen by more than one specialty, with the exception of psoriasis and PsA, he said that “the idea is to start a dialogue and increase communication between specialists.”

Dr. Merola noted that while the algorithm in many respects is meant to guide a physician in a specialty in appropriate medication decisions, at the same time he hopes that “it opens a dialogue and communication with the other specialty who tends to oversee this particular disease state or class of medicine to really work together to try to find the right drug for the right person.”

For patients with a mild skin eruption and a controlled underlying disease, the algorithm recommends a “treat through” approach by continuing anti-TNF therapy and treating psoriasis symptoms with topical steroids, ultraviolet therapy, methotrexate, cyclosporine, or acitretin, and to consider dapsone in cases of pustular psoriasis. However, the researchers noted that “treat through” studies have reported complete symptom resolution in 26%-41% of patients.

For patients with recalcitrant or worsening TNFi-induced psoriasis or patients with mild skin eruptions with an uncontrolled underlying disease, the researchers proposed considering switching to a different anti-TNF therapy, although studies have shown complete resolution of symptoms in only 5%-37% of patients.

If patients worsen from there, or if they have moderate to-severe skin eruption with uncontrolled underlying disease, they could be considered for switching to a different drug class and treated based on their underlying disease, along with treatment for psoriasis symptoms. This approach has been shown to completely resolve lesions in up to 64% of cases, they said. IBD patients could benefit from ustekinumab, vedolizumab, 6-mercaptopurine, or azathioprine as an alternative to anti-TNF therapy. Those patients with psoriasis should be considered for guselkumab, while ustekinumab, ixekizumab, secukinumab, and apremilast are effective treatments for patients with psoriasis and PsA. Patients with RA could receive treatment with tocilizumab, rituximab, abatacept, and tofacitinib, the authors wrote.

Dr. Merola reported serving as a consultant and/or investigator for Merck Research Laboratories, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Samumed, Celgene, Sanofi Regeneron, GlaxoSmithKline, Almirall, Sun Pharma, Biogen, Pfizer, Incyte, Aclaris, and Leo Pharma.

SOURCE: Li SJ et al. J Psoriasis Psoriatic Arthritis. 2018 Nov 21. doi: 10.1177/2475530318810851.

Patients with tumor necrosis factor inhibitor–induced psoriasis could potentially be switched to a different drug class if they have moderate to severe skin eruption or mild skin eruption with an uncontrolled underlying disease such as inflammatory bowel disease, psoriasis, psoriatic arthritis, or rheumatoid arthritis, according to a new treatment algorithm proposed by researchers from Brigham and Women’s Hospital and Harvard Medical School in Boston.

The researchers outlined the prevalence of tumor necrosis factor–alpha inhibitor (TNFi)-induced psoriasis in a literature review of inflammatory bowel disease (IBD), psoriasis, psoriatic arthritis (PsA), and rheumatoid arthritis (RA) and identified an estimated rate of between 2.3% and 5% in patients with RA and between 1.6% and 2.7% in patients with IBD. Although there have been reports of TNFi-induced psoriasis in patients with psoriasis and PsA, the prevalence is unclear, they wrote in the Journal of Psoriasis and Psoriatic Arthritis.

The authors then created an algorithm to manage and treat TNFi-induced psoriasiform skin eruptions with decisions to continue therapy and “treat through” symptoms, switch to a different anti-TNF therapy, or switch to a different drug class based on severity of symptoms, whether the underlying disease is well controlled, and how patients with those underlying diseases have fared with those specific therapies or agents.

“We’ve shifted gears over the past decade, and we’ve gone from having very few agents and trying to keep patients desperately on one or two agents because we didn’t want to have to give up on them for their other comorbid disease, whether it was Crohn’s, colitis, RA, or whatever it may be,” senior author Joseph Merola, MD, director of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston, said in an interview. “We’re now in an area where we can have an algorithm like this, and we have so many more mechanistic options to move to.”

Dr. Merola, who is board certified in dermatology and rheumatology, said the algorithm is meant to “open a dialogue” with other specialists in different areas and raise awareness of treatments in related but separate fields. For diseases not often seen by more than one specialty, with the exception of psoriasis and PsA, he said that “the idea is to start a dialogue and increase communication between specialists.”

Dr. Merola noted that while the algorithm in many respects is meant to guide a physician in a specialty in appropriate medication decisions, at the same time he hopes that “it opens a dialogue and communication with the other specialty who tends to oversee this particular disease state or class of medicine to really work together to try to find the right drug for the right person.”

For patients with a mild skin eruption and a controlled underlying disease, the algorithm recommends a “treat through” approach by continuing anti-TNF therapy and treating psoriasis symptoms with topical steroids, ultraviolet therapy, methotrexate, cyclosporine, or acitretin, and to consider dapsone in cases of pustular psoriasis. However, the researchers noted that “treat through” studies have reported complete symptom resolution in 26%-41% of patients.

For patients with recalcitrant or worsening TNFi-induced psoriasis or patients with mild skin eruptions with an uncontrolled underlying disease, the researchers proposed considering switching to a different anti-TNF therapy, although studies have shown complete resolution of symptoms in only 5%-37% of patients.

If patients worsen from there, or if they have moderate to-severe skin eruption with uncontrolled underlying disease, they could be considered for switching to a different drug class and treated based on their underlying disease, along with treatment for psoriasis symptoms. This approach has been shown to completely resolve lesions in up to 64% of cases, they said. IBD patients could benefit from ustekinumab, vedolizumab, 6-mercaptopurine, or azathioprine as an alternative to anti-TNF therapy. Those patients with psoriasis should be considered for guselkumab, while ustekinumab, ixekizumab, secukinumab, and apremilast are effective treatments for patients with psoriasis and PsA. Patients with RA could receive treatment with tocilizumab, rituximab, abatacept, and tofacitinib, the authors wrote.

Dr. Merola reported serving as a consultant and/or investigator for Merck Research Laboratories, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Samumed, Celgene, Sanofi Regeneron, GlaxoSmithKline, Almirall, Sun Pharma, Biogen, Pfizer, Incyte, Aclaris, and Leo Pharma.

SOURCE: Li SJ et al. J Psoriasis Psoriatic Arthritis. 2018 Nov 21. doi: 10.1177/2475530318810851.

BONITA SPRINGS, FLA. – Urine drug screening is a vital part of clinical care, but many clinicians say they do not know enough about how the tests work, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Rebecca Ann Payne, MD, said clinicians, including residents, tend to cite little training as a reason for their uncertainty about how to interpret urine drug screen results. Also, primary care clinicians say they need more education on implementing and interpreting the screens.

The good news is that medicine and pediatric residents said they felt that a 30-minute educational program significantly boosted their knowledge base and comfort in interpreting urine drug screens, said Dr. Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health–University of South Carolina Medical Group. She offered several points that addiction psychiatrists should be aware of:

• Be careful not to put too much stock in the results.

“A positive test doesn’t necessarily mean there’s a substance use disorder,” she said. “You still need to walk through those criteria with your patients. And a positive test doesn’t mean they’re physically dependent upon it.” She said she sometimes hears from patients who say that they’d been on a certain treatment – then failed a test given by their clinician – and had their treatment stripped away.

“Drug testing is meant to be a source of information and should not dictate treatment,” she said. “I have found it’s not unusual to hear from the community that decisions are being made solely on the results of these tests, which can be problematic.”

• Point-of-care tests, which sometimes can be bought in drug stores, she said, are “much less than perfect.”

The false-positive rate for benzodiazepines has been found to be 61%; and for methadone, it is 46%; for opioids, 22%; and for amphetamines, 21%.

• Know what your lab is actually testing for, because “it’s not universal.”

She emphasized knowing the particulars of opiate testing.

“A lot of times in a hospital setting, your lab is really only testing those opiates that are directly derived from the poppy – we’re talking about things like codeine, heroin, morphine. They’re not testing for things like your semi-synthetics or your full-synthetic opiates.”

• Know the answer to the question: “Can you get a positive result on a marijuana drug screen just from passive inhalation?”

Physicians often will be confronted by patients who insist they were only in the car or in the same room with someone who was smoking marijuana. How likely is it that their test could be positive?

“Possible,” she said, “but not probable.”

Dr. Payne’s key interest areas include teaching medical students and residents, treating substance use and psychiatric disorders that are comorbid, and conducting research in addiction psychiatry.

BONITA SPRINGS, FLA. – Urine drug screening is a vital part of clinical care, but many clinicians say they do not know enough about how the tests work, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Rebecca Ann Payne, MD, said clinicians, including residents, tend to cite little training as a reason for their uncertainty about how to interpret urine drug screen results. Also, primary care clinicians say they need more education on implementing and interpreting the screens.

The good news is that medicine and pediatric residents said they felt that a 30-minute educational program significantly boosted their knowledge base and comfort in interpreting urine drug screens, said Dr. Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health–University of South Carolina Medical Group. She offered several points that addiction psychiatrists should be aware of:

• Be careful not to put too much stock in the results.

“A positive test doesn’t necessarily mean there’s a substance use disorder,” she said. “You still need to walk through those criteria with your patients. And a positive test doesn’t mean they’re physically dependent upon it.” She said she sometimes hears from patients who say that they’d been on a certain treatment – then failed a test given by their clinician – and had their treatment stripped away.

“Drug testing is meant to be a source of information and should not dictate treatment,” she said. “I have found it’s not unusual to hear from the community that decisions are being made solely on the results of these tests, which can be problematic.”

• Point-of-care tests, which sometimes can be bought in drug stores, she said, are “much less than perfect.”

The false-positive rate for benzodiazepines has been found to be 61%; and for methadone, it is 46%; for opioids, 22%; and for amphetamines, 21%.

• Know what your lab is actually testing for, because “it’s not universal.”

She emphasized knowing the particulars of opiate testing.

“A lot of times in a hospital setting, your lab is really only testing those opiates that are directly derived from the poppy – we’re talking about things like codeine, heroin, morphine. They’re not testing for things like your semi-synthetics or your full-synthetic opiates.”

• Know the answer to the question: “Can you get a positive result on a marijuana drug screen just from passive inhalation?”

Physicians often will be confronted by patients who insist they were only in the car or in the same room with someone who was smoking marijuana. How likely is it that their test could be positive?

“Possible,” she said, “but not probable.”

Dr. Payne’s key interest areas include teaching medical students and residents, treating substance use and psychiatric disorders that are comorbid, and conducting research in addiction psychiatry.

BONITA SPRINGS, FLA. – Urine drug screening is a vital part of clinical care, but many clinicians say they do not know enough about how the tests work, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Rebecca Ann Payne, MD, said clinicians, including residents, tend to cite little training as a reason for their uncertainty about how to interpret urine drug screen results. Also, primary care clinicians say they need more education on implementing and interpreting the screens.

The good news is that medicine and pediatric residents said they felt that a 30-minute educational program significantly boosted their knowledge base and comfort in interpreting urine drug screens, said Dr. Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health–University of South Carolina Medical Group. She offered several points that addiction psychiatrists should be aware of:

• Be careful not to put too much stock in the results.

“A positive test doesn’t necessarily mean there’s a substance use disorder,” she said. “You still need to walk through those criteria with your patients. And a positive test doesn’t mean they’re physically dependent upon it.” She said she sometimes hears from patients who say that they’d been on a certain treatment – then failed a test given by their clinician – and had their treatment stripped away.

“Drug testing is meant to be a source of information and should not dictate treatment,” she said. “I have found it’s not unusual to hear from the community that decisions are being made solely on the results of these tests, which can be problematic.”

• Point-of-care tests, which sometimes can be bought in drug stores, she said, are “much less than perfect.”

The false-positive rate for benzodiazepines has been found to be 61%; and for methadone, it is 46%; for opioids, 22%; and for amphetamines, 21%.

• Know what your lab is actually testing for, because “it’s not universal.”

She emphasized knowing the particulars of opiate testing.

“A lot of times in a hospital setting, your lab is really only testing those opiates that are directly derived from the poppy – we’re talking about things like codeine, heroin, morphine. They’re not testing for things like your semi-synthetics or your full-synthetic opiates.”

• Know the answer to the question: “Can you get a positive result on a marijuana drug screen just from passive inhalation?”

Physicians often will be confronted by patients who insist they were only in the car or in the same room with someone who was smoking marijuana. How likely is it that their test could be positive?

“Possible,” she said, “but not probable.”

Dr. Payne’s key interest areas include teaching medical students and residents, treating substance use and psychiatric disorders that are comorbid, and conducting research in addiction psychiatry.

A relatively high proportion of pediatric visits to the emergency department are related to psychiatric symptoms, oftentimes with suicidal or violent ideation.¹ Given that pediatric emergencies related to psychiatric symptoms are on the increase, clinicians frequently are called to assess children and adolescents with symptoms of aggression and violence. Management of these cases can be tricky.

Case presentation

Henry is a 6-year-old boy with mild developmental delays and possible anxiety who was brought to the emergency department because of concerns on the bus. For about a month, Henry, who is repeating his kindergarten year, had been struggling with getting on and off the bus and with other transitions at school. These struggles had been attributed to anxiety. He was started on sertraline and the dose was increased about 2 weeks later. Soon thereafter he complained of stomach upset with the sertraline, refused to take the medicine, and had a very hard day at school. He required one-on-one attention for unsafe behavior most of that day, and he missed most of his lunch and recess. His school support team was able to get him onto the bus at the end of the day, but he refused to get off of the bus at home. He became violent with the bus driver, kicking and biting him until the police were called. The police called EMS and he was brought into the emergency department after fighting to get on the transport stretcher. He was eventually brought into a secure exam room in the emergency department, but was unable to be fully assessed because he would only make animal noises when approached. His father already had been called, but was unable to calm him down. The emergency department physician was unable to approach Henry because he began swinging at him as soon as the physician entered the room. An emergent psychiatric consultation was called to determine what medication to give to Henry to calm him down and to assess him for possible psychosis.

Case discussion

It sounds like Henry was having a severe tantrum exacerbated by a number of factors. First of all, this is a child who struggles with transitions. That day had been loaded with transitions, eventually leading him to be in an unfamiliar environment with many unfamiliar faces. Even the familiar face of his father wasn’t enough to help because he was overly stimulated and scared. Next, he was probably hungry. We know for certain that he missed lunch, and several hours into his presentation there were no breaks to deal with his basic needs. The first approach to assessment of aggressive behavior in the emergency setting is to try to care for the basic needs of the individual to deescalate the situation. Finally, he had recently been started on sertraline, a selective serotonin reuptake inhibitor. He had been having some dyspepsia and/or nausea with the sertraline, leading to his having missed some doses. Some children and adolescents have a discontinuation syndrome, which can be more severe in younger children and with medications that have shorter half-lives.² In Henry’s case, a missed dose or two can be enough to trigger this discontinuation response leading to more aggressive behavior.

Case follow-up

The child and adolescent psychiatrist called to the case received a history from the primary team. When he started to try to talk with the parent outside of the room, the child became upset. He was able to gather the information that Henry also had skipped breakfast. In an attempt to calm the patient down, the psychiatrist addressed Henry using a nonjudgmental, nonconfrontational, collaborative approach, incorporating play. Henry responded to this approach and allowed the psychiatrist to ask a few questions about basic needs, and admitted that he was hungry. He was offered a turkey sandwich, which was rapidly ingested. The tantrum slowly subsided. Within about 30 minutes (and with some more food), the child was able to sit on his parent’s lap and finish the interview. The decision was made to have him follow up with his primary care provider to change to an SSRI with a longer half-life, such as fluoxetine, as he did seem to be experiencing some discontinuation even after missing just a dose or two of sertraline.

RatRanch/Flickr/CC by 2.0 RatRanch/Flickr/CC by 2.0

When dealing with emergent, aggressive behavior, food isn’t always the best medicine, but sometimes it is. In the context of aggression with children, it is critical to evaluate for triggers that can worsen a fight or flight response. Environmental barriers to the child’s regaining control include hunger, thirst, a full bladder, constipation, or other pain. Attending to these issues first sometimes can help avoid sedating medications, which can prolong emergency visits and lead to unwelcome side effects.
 

Dr. Althoff is associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Email him at pdnews@mdedge.com.

References

1. Pediatrics. 2011 May;127(5):e1356-66.

2. J Can Acad Child Adolesc Psychiatry. 2011 Feb;20(1):60-7.

A relatively high proportion of pediatric visits to the emergency department are related to psychiatric symptoms, oftentimes with suicidal or violent ideation.¹ Given that pediatric emergencies related to psychiatric symptoms are on the increase, clinicians frequently are called to assess children and adolescents with symptoms of aggression and violence. Management of these cases can be tricky.

Case presentation

Henry is a 6-year-old boy with mild developmental delays and possible anxiety who was brought to the emergency department because of concerns on the bus. For about a month, Henry, who is repeating his kindergarten year, had been struggling with getting on and off the bus and with other transitions at school. These struggles had been attributed to anxiety. He was started on sertraline and the dose was increased about 2 weeks later. Soon thereafter he complained of stomach upset with the sertraline, refused to take the medicine, and had a very hard day at school. He required one-on-one attention for unsafe behavior most of that day, and he missed most of his lunch and recess. His school support team was able to get him onto the bus at the end of the day, but he refused to get off of the bus at home. He became violent with the bus driver, kicking and biting him until the police were called. The police called EMS and he was brought into the emergency department after fighting to get on the transport stretcher. He was eventually brought into a secure exam room in the emergency department, but was unable to be fully assessed because he would only make animal noises when approached. His father already had been called, but was unable to calm him down. The emergency department physician was unable to approach Henry because he began swinging at him as soon as the physician entered the room. An emergent psychiatric consultation was called to determine what medication to give to Henry to calm him down and to assess him for possible psychosis.

Case discussion

It sounds like Henry was having a severe tantrum exacerbated by a number of factors. First of all, this is a child who struggles with transitions. That day had been loaded with transitions, eventually leading him to be in an unfamiliar environment with many unfamiliar faces. Even the familiar face of his father wasn’t enough to help because he was overly stimulated and scared. Next, he was probably hungry. We know for certain that he missed lunch, and several hours into his presentation there were no breaks to deal with his basic needs. The first approach to assessment of aggressive behavior in the emergency setting is to try to care for the basic needs of the individual to deescalate the situation. Finally, he had recently been started on sertraline, a selective serotonin reuptake inhibitor. He had been having some dyspepsia and/or nausea with the sertraline, leading to his having missed some doses. Some children and adolescents have a discontinuation syndrome, which can be more severe in younger children and with medications that have shorter half-lives.² In Henry’s case, a missed dose or two can be enough to trigger this discontinuation response leading to more aggressive behavior.

Case follow-up

The child and adolescent psychiatrist called to the case received a history from the primary team. When he started to try to talk with the parent outside of the room, the child became upset. He was able to gather the information that Henry also had skipped breakfast. In an attempt to calm the patient down, the psychiatrist addressed Henry using a nonjudgmental, nonconfrontational, collaborative approach, incorporating play. Henry responded to this approach and allowed the psychiatrist to ask a few questions about basic needs, and admitted that he was hungry. He was offered a turkey sandwich, which was rapidly ingested. The tantrum slowly subsided. Within about 30 minutes (and with some more food), the child was able to sit on his parent’s lap and finish the interview. The decision was made to have him follow up with his primary care provider to change to an SSRI with a longer half-life, such as fluoxetine, as he did seem to be experiencing some discontinuation even after missing just a dose or two of sertraline.

RatRanch/Flickr/CC by 2.0 RatRanch/Flickr/CC by 2.0

When dealing with emergent, aggressive behavior, food isn’t always the best medicine, but sometimes it is. In the context of aggression with children, it is critical to evaluate for triggers that can worsen a fight or flight response. Environmental barriers to the child’s regaining control include hunger, thirst, a full bladder, constipation, or other pain. Attending to these issues first sometimes can help avoid sedating medications, which can prolong emergency visits and lead to unwelcome side effects.
 

Dr. Althoff is associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Email him at pdnews@mdedge.com.

References

1. Pediatrics. 2011 May;127(5):e1356-66.

2. J Can Acad Child Adolesc Psychiatry. 2011 Feb;20(1):60-7.

A relatively high proportion of pediatric visits to the emergency department are related to psychiatric symptoms, oftentimes with suicidal or violent ideation.¹ Given that pediatric emergencies related to psychiatric symptoms are on the increase, clinicians frequently are called to assess children and adolescents with symptoms of aggression and violence. Management of these cases can be tricky.

Case presentation

Henry is a 6-year-old boy with mild developmental delays and possible anxiety who was brought to the emergency department because of concerns on the bus. For about a month, Henry, who is repeating his kindergarten year, had been struggling with getting on and off the bus and with other transitions at school. These struggles had been attributed to anxiety. He was started on sertraline and the dose was increased about 2 weeks later. Soon thereafter he complained of stomach upset with the sertraline, refused to take the medicine, and had a very hard day at school. He required one-on-one attention for unsafe behavior most of that day, and he missed most of his lunch and recess. His school support team was able to get him onto the bus at the end of the day, but he refused to get off of the bus at home. He became violent with the bus driver, kicking and biting him until the police were called. The police called EMS and he was brought into the emergency department after fighting to get on the transport stretcher. He was eventually brought into a secure exam room in the emergency department, but was unable to be fully assessed because he would only make animal noises when approached. His father already had been called, but was unable to calm him down. The emergency department physician was unable to approach Henry because he began swinging at him as soon as the physician entered the room. An emergent psychiatric consultation was called to determine what medication to give to Henry to calm him down and to assess him for possible psychosis.

Case discussion

It sounds like Henry was having a severe tantrum exacerbated by a number of factors. First of all, this is a child who struggles with transitions. That day had been loaded with transitions, eventually leading him to be in an unfamiliar environment with many unfamiliar faces. Even the familiar face of his father wasn’t enough to help because he was overly stimulated and scared. Next, he was probably hungry. We know for certain that he missed lunch, and several hours into his presentation there were no breaks to deal with his basic needs. The first approach to assessment of aggressive behavior in the emergency setting is to try to care for the basic needs of the individual to deescalate the situation. Finally, he had recently been started on sertraline, a selective serotonin reuptake inhibitor. He had been having some dyspepsia and/or nausea with the sertraline, leading to his having missed some doses. Some children and adolescents have a discontinuation syndrome, which can be more severe in younger children and with medications that have shorter half-lives.² In Henry’s case, a missed dose or two can be enough to trigger this discontinuation response leading to more aggressive behavior.

Case follow-up

The child and adolescent psychiatrist called to the case received a history from the primary team. When he started to try to talk with the parent outside of the room, the child became upset. He was able to gather the information that Henry also had skipped breakfast. In an attempt to calm the patient down, the psychiatrist addressed Henry using a nonjudgmental, nonconfrontational, collaborative approach, incorporating play. Henry responded to this approach and allowed the psychiatrist to ask a few questions about basic needs, and admitted that he was hungry. He was offered a turkey sandwich, which was rapidly ingested. The tantrum slowly subsided. Within about 30 minutes (and with some more food), the child was able to sit on his parent’s lap and finish the interview. The decision was made to have him follow up with his primary care provider to change to an SSRI with a longer half-life, such as fluoxetine, as he did seem to be experiencing some discontinuation even after missing just a dose or two of sertraline.

RatRanch/Flickr/CC by 2.0 RatRanch/Flickr/CC by 2.0

When dealing with emergent, aggressive behavior, food isn’t always the best medicine, but sometimes it is. In the context of aggression with children, it is critical to evaluate for triggers that can worsen a fight or flight response. Environmental barriers to the child’s regaining control include hunger, thirst, a full bladder, constipation, or other pain. Attending to these issues first sometimes can help avoid sedating medications, which can prolong emergency visits and lead to unwelcome side effects.
 

Dr. Althoff is associate professor of psychiatry, psychology, and pediatrics at the University of Vermont, Burlington. He is director of the division of behavioral genetics and conducts research on the development of self-regulation in children. Email him at pdnews@mdedge.com.

References

1. Pediatrics. 2011 May;127(5):e1356-66.

2. J Can Acad Child Adolesc Psychiatry. 2011 Feb;20(1):60-7.