AbbVie announced the US Food and Drug Administration has approved dalbavancin (Dalvance) for treatment of acute bacterial skin and skin structure infection (ABSSSI) in pediatric patients.1 It is the first single-dose treatment option administered as a 30-minute intravenous (IV) infusion for ABSSSI caused by susceptible Gram-positive bacteria in pediatric patients which includes infections caused by methicillin-resistant 

"Serious infections in children can be difficult to treat and the impact of ABSSSI among children is significant, as these infections often require IV antibiotics, resulting in hospitalization," said Margaret Burroughs, medical director, infectious diseases, AbbVie, Libertyville, Illinois. "This pediatric approval for Dalvance as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI."

This approval is based on results from a multicenter, open-label, actively controlled clinical trial (NCT02814916) evaluating dalbavancin as treatment in pediatric patients from 0 to 18 years diagnosed with ABSSI and 3 pharmacokinetic trials (NCT01946568, NCT02688790, and NCT00678106).

In NCT02814916, the safety and efficacy of dalbavancin was compared to vancomycin, intravenous oxacillin, and flucloxacillin. Patients were randomized 3:3:1 to be treated with single-dose dalbavancin, 2-dose dalbavancin, or comparator.

The primary endpoint of the study was to evaluate the safety and tolerability of dalbavancin. The trial was not powered for comparative inferential efficacy analysis. There was an analysis of 183 patients with ABSSI in a modified intent-to-treat (mITT) population, which included all randomized patients who received any dose of study drug and had a diagnosis of ABSSI by gram-positive organisms, to evaluate the treatment efficacy.

The analysis evaluated patient response at 48 to 72 hours on a 20% or greater reduction in lesion size compared to baseline and no past of rescue antibacterial therapy for pediatric patients 3 months and older. Of the 75 patients analyzed, 73 achieved an early clinical response (97.3%) in the single-dose arm, 73 out of 78 (93.6%) of the double-dose arm, and 26 of 30 (86.7%) patients in the comparator arm.

These results were similar to those observed in adults. The approved recommended dosage for dalbavancin in pediatric patients with a creatinine clearance of 30 mL/min/1.73m2 and above is a single-dose regimen based on the age and weight of the pediatric patient.

This article was originally published by Dermatology Times.

1. Dalvance® (Dalbavancin) receives FDA approval to treat acute bacterial skin and skin structure infections in pediatric patients | Abbvie news center. Accessed July 27, 2021. 

https://news.abbvie.com/news/press-releases/dalvance-dalbavancin-receives-fda-approval-to-treat-acute-bacterial-skin-and-skin-structure-infections-in-pediatric-patients.htm?view_id=5591

Articles

Dalbavancin has received US Food and Drug Administration (FDA) approval to treat acute bacterial skin and skin structure infections in pediatric patients.

FDA approval given to dalbavancin for acute skin infections 

Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

In a hospital setting, awareness of medical conditions that are most prevalent, have the highest costs, or greatest variations in costs can be helpful in determining which could most benefit from research funding. A 

Investigators performed a retrospective cohort study of children who had hospital encounters at 45 tertiary care US children’s hospitals. The Pediatric Clinical Classification System was used to classify the primary diagnosis discharge code. The Cost Master Index was used to determine the standard cost of hospital goods and services used for care, in order to eliminate the high variation in those costs across hospitals.

There were 2,882,490 inpatient hospital encounters included in the report. From a list of 50 most prevalent and 50 most costly conditions, there were 74 total conditions, of which 49 (66.2%) were medical, 15 (20.3%) were surgical, and 10 (13.5%) were medical/surgical. The top 10 costly conditions made up $12.4 billon of $33.4 billon total costs and 33.8% of all of the conditions. The highest cost per encounter was seen with extreme immaturity conditions (ie, birth weight 500-749 g) at $382,910 (95% CI, $368,084-$397,736). The highest degree of interhospital variability in cost was seen with major depressive disorder, type 1 diabetes with complications, diabetic ketoacidosis, and acute appendicitis without peritonitis. Conditions that had high prevalence, variation in cost, and overall cost were major depressive disorder (cost rank, 19; prevalence rank, 10), scoliosis (cost rank, 6; prevalence rank, 38), acute appendicitis with peritonitis (cost rank, 13; prevalence rank, 11), asthma (cost rank, 10; prevalence rank, 2), and dehydration (cost rank, 24; prevalence rank, 8).

Those in charge of determining where to allocate research funding for improved care and outcomes should keep in mind the conditions that were found to be most common and costly.

1. Gill P, Anwar M, Thavam T, et al. Identifying conditions with high prevalence, cost, and variation in cost in US children’s hospitals. 

. 2021;4(7):e2117816. doi:10.1001/jamanetworkopen.2021.17816

Knowing what conditions are the most prevalent and costly in hospitals can help determine the focus of future research, which can ensure better care. A report sheds some light.

What are the common but costly conditions treated at hospitals?

In only a matter of weeks, children and teenagers will be back at school. Many schools will be dropping virtual only or hybrid model learning at the start of the year. With so many children returning to the classroom as well as the rise of the delta variant of COVID-19, there are many questions that parents and older patients may have about returning. To address these concerns, the Infectious Disease Society of America held a briefing this morning to tackle the biggest questions in both K-12 and higher education and the delta variant.

editor-in-chief Tina Q. Tan, MD, FAAP, FIDSA, FPIDS, stressed that COVID-19 was definitely a cause for concern in children with 41 million infected with the disease, 18,000 requiring hospitalization, and 350 deaths. In addition, over 4000 of those children also developed multisystem inflammatory syndrome in children. Tan said that all who are eligible to be vaccinated should do so, nothing that only 30% of children aged 12 to 17 years are fully vaccinated. She affirmed her support of the American Academy of Pediatrics universal masking recommendations, in addition to maintaining social distancing of at least 3 feet, creating small cohorts of students and staff, and ensuring good hand hygiene as well as good ventilation. Due to the difficulty in implementing a protocol, testing in K-12 is likely not going to be common. Tan did address the fact that a number of states and cities have indicated that they will not require masking in schools. In those cases, she recommended that parents still send children to school with a mask as well as encouraging the child to maintain distance when possible.

Higher education offers a much different scenario said Preeti Malani, MD, MS, MSJ, FIDSA, FSHEA, professor of medicine in the division of infectious diseases, University of Michigan in Ann Arbor. Some institutions of higher education have mandated the vaccination for all students returning to campus, with a judge upholding one at Indiana University in Bloomington and some are setting additional fees for students who choose to go unvaccinated. Malani did note the institutions should be prepared to provide the vaccine for international students, as many may be unable to get the vaccine in their home country or the vaccine they did receive may not be one of those approved in the United States. She emphasized that even with the vaccine that the return to campus is not free of risk, but students who are vaccinated and are returning to campuses in communities with a high vaccination rate and low spread of the disease should feel comfortable with their risk level.

The Infectious Disease Society of America discussed keeping children and teenagers safe in the upcoming school year.

What the school year may hold

In response to the devastating COVID-19 pandemic in 2020, the federal government and state governments took a number of overlapping actions to promote telehealth as an alternative method for effectively delivering patient care while lowering risk of transmission – passing laws, updating regulations, issuing waivers and executive and agency orders, and releasing sub-regulatory guidance. Insurance companies and providers took corresponding steps to embrace telehealth, standing up new telehealth platforms and processes almost overnight. The result was a significant expansion of telehealth services, programs, and technologies that enabled patients to access critical care from the comfort of their homes, reduce the risk of transmission, and enable providers to reserve in-person care for higher acuity conditions.

These changes were crucial because regulatory and payment restrictions on telehealth limited its utility prior to the pandemic, except in certain situations and for specialized care for specific conditions. The COVID-19 expansion of telehealth resulted from a joint federal-state effort to waive, amend, and remove those restrictions. Importantly, inconsistencies in the approaches taken by states and the federal government, and inconsistent messaging from regulators, resulted in differing regulatory regimes for providers, particularly those who sought to provide care to patients across state lines, which was necessary as patients and providers scattered throughout the country in response to the pandemic. As a result, health care providers have raised questions regarding the permissibility of telehealth practice across state lines, and of potential exposure to audits for providers who have been reimbursed for telehealth services delivered to patients in states where providers may not be licensed. These questions – and the differences in approach taken between states – are becoming more acute as states terminate or allow state-level emergency declarations to expire, which in many cases end waivers that have enabled telehealth services during the pandemic.

Differences in telehealth regulation among New England states highlight the challenges for providers, and regulatory risks for practice across state lines. In response to the pandemic, Connecticut Governor Ned Lamont suspended state licensure requirements for telehealth services to facilitate the provision of telehealth services to patients in Connecticut by providers licensed in good standing in other states. Notably, out-of-state providers who met the minimum criteria under Governor Lamont’s order (and corresponding state Department of Public Health (DPH) orders available here and here) were authorized to provide telehealth services to individuals in Connecticut without completing any Connecticut registration or receiving a specific emergency license. The Connecticut legislature codified this approach with emergency legislation in July 2020 that was subsequently extended by Governor Lamont via executive order, and then superseded by follow-up legislation in 2021. As a result, out-of-state providers that maintain sufficient malpractice insurance are allowed to continue providing telehealth services to patients in Connecticut until DPH orders otherwise.

By contrast, Massachusetts Governor Baker’s order expanding access to telehealth services allowed for emergency licensure of physicians licensed in another state in good standing, but such out-of-state physicians were required to present a license verification to the Massachusetts Board of Registration in Medicine (BoRM) in order to be issued an emergency Massachusetts license. The Massachusetts Bureau of Health Professions Licensure then issued an order on licensure noting that BoRM “shall refrain from taking disciplinary action or other enforcement action solely upon the basis of providing telemedicine services to a patient in Massachusetts provided that the person providing such telemedicine services holds a valid Massachusetts license at the time the service is provided, including” an emergency license issued in response to COVID-19. Accordingly, to be able to provide telehealth services to a patient located in Massachusetts at the time of the visit, a physician would need to have obtained an emergency license from BoRM or other applicable licensure. Unlike in Connecticut, simply being licensed in good standing in another state was not sufficient to be licensed to provide telehealth services to individuals in Massachusetts.

Rhode Island took a third approach, in which the Department of Health’s (DOH) Board of Medical Licensure and Discipline (BMLD) issued guidance stating that although under normal circumstances “a physician not licensed to practice in Rhode Island cannot . . . treat a patient physically located in Rhode Island” due to the COVID-19 pandemic, the BMLD encouraged “all physicians to use telemedicine to deliver care to their patients” and would “not take action against physicians not licensed to practice in Rhode Island who, during the state of emergency, use telemedicine to deliver care to their established Rhode Island patients.” Interestingly, this guidance does not appear to have been accompanied by licensure waivers issued via executive order, but DOH did establish an emergency licensure approval process for out-of-state physicians who sought to obtain a license. Additionally, in early July 2021, the Rhode Island legislature codified modifications to the Rhode Island telemedicine parity law that had been included in Governor Raimondo’s executive order 20-06, which are intended to expand access and improve telehealth technologies in Rhode Island. Ultimately, however, out-of-state physicians could seek to obtain an emergency license from DOH (which are no longer being issued), or could rely on the BMLD guidance, which is limited by the duration of the state of emergency.

The different approaches among states, coupled with uncertainty regarding licensure rules applicable to telehealth encounters, almost certainly resulted in cases of non-compliance with various emergency orders, waivers, processes, and legislation. For example, although the location of the patient during the encounter generally governs licensure, providers may not have always be in a position to determine the patient’s location at the time of the encounter, thereby inadvertently running afoul of a state’s medical practice and licensure regulations. Whether such encounters are billable, or if already billed, could be subject to recoupment efforts, is an open question as payors and the government initiate audits and weigh the impact of the sudden expansion of telehealth on the health care system. Given the varying, and at times conflicting, guidance and requirements from regulators and executive orders, any out-of-state telehealth noncompliance may be immaterial from a reimbursement perspective as long as the service was provided in accordance with the standard of care. The government and payors will likely focus audit and recoupment efforts on bad actors who took advantage of COVID-19 programs for personal gain, and not to expand access to necessary care. However, the Office of the Inspector General has announced a more general approach as part of its work plan, and will review the use of Medicare telehealth services during the COVID-19 pandemic, and audit Medicare Part B telehealth services specifically. Accordingly, even providers who acted in good faith may be subject to such reviews and to heightened scrutiny of their telehealth activities. Therefore, prudent providers will assess their current compliance with licensure requirements, and plans for continued telehealth services in-state and across state lines, as COVID-19 waivers end and states determine how to move forward with telehealth services. Providers who received emergency licenses or similar in-state authorizations may want to follow up with state boards to determine options for maintaining licensure (e.g., by applying for a full license). It may also be advisable for providers to integrate processes into telehealth platforms that allow for documentation of patient location, and to implement restrictions on the provision of telehealth services to patients located in a state where the provider is not licensed. Finally, providers would also be well advised to advocate for the passing of legislation to maintain current telehealth flexibilities beyond the COVID-19 pandemic in order to maintain increased access to care for their patients.

This article was originally published by Medical Economics.

How a hodgepodge of federal and state telehealth waivers creates compliance concerns for providers practicing across state lines.

Confusion with telehealth could create issues

Despite its efficacy, the flu shot rates are still relatively low in children with only 63% of US children receiving it for the 2018-2019 influenza season. Children who are hospitalized often have conditions that may predispose them to influenza morbidity and mortality, but coverage rates are frequently lower than the national average. An 

 examined whether a clinical decision support strategy could improve influenza vaccination rates before discharge from the hospital.

Investigators conducted this quality improvement study in children who were eligible for the season influenza vaccine and were hospitalized in a tertiary pediatric health system that provides care to more than half a million patients every year in 3 hospitals. The intervention included putting a default flu short order into admission sets for eligible patients, providing a script to offer the flu shot that uses the presumptive strategy, and just-in-time education for clinicians that addressed vaccine eligibility.

There were 17,740 hospitalizations, mostly among Black (n = 8943) and White (n = 7559) patients with many using public insurance (n = 11,724). Of those hospitalizations, 10,997 were eligible for the influenza vaccine in the 2019-2020 influenza season, which were split evenly into the intervention group and concurrent controls. A pool of 6743 hospitalizations from 2018-2019 served as historical controls. Vaccine administration rates were 31% in the intervention group, 19% in the concurrent control group, and 14% in the historical control group. Following adjustment, investigators found that the odds of being administered an influenza vaccine was 3.25 (95% CI, 2.94 – 3.59) times higher in the intervention group and 1.28 (95% CI, 1.15-1.42) times higher in the concurrent controls than in the historical controls.

The investigators concluded that the program appeared to be linked to a definite improvement in vaccination rates among children who are hospitalized. Further study should see whether the benefits are sustained across seasons and whether the model would have similar results at other institutions.

1. Orenstein E, El Sayed-Ali O, Kandaswamy S, et al. Evaluation of a clinical decision support strategy to increase influenza vaccination among hospitalized children before inpatient discharge. 

. 2021;4(7):e2117809. doi: 10.1001/jamanetworkopen.2021.17809

Hospitalized children are often at risk of influenza morbidity and mortality, which means that influenza vaccination before discharge can help mitigate those risks. A study discusses how a quality improvement program could make a difference.

Improving flu shot rates in hospitalized children

“Helping parents cope with adolescent behavior

 provides a comprehensive review of emotional and behavioral changes that occur throughout the adolescent years. The article focuses the role of pediatricians helping parents and adolescents understand the vast array of emotions including promising behaviors as well as at-risk behaviors, eg, substance use, that can lead to troubling consequences for the adolescent and the parents. Jellinek describes the flux of emotions in cycles that occur on a pendulum with behaviors that demonstrate the promise of entering young adulthood with mature cognitive and emotional responses to a more toddler-like behavioral swing that frustrates parents, teachers, coaches, their friends, and perhaps, themselves. I highly recommend reading Jellinek’s article.

Thinking about adolescent emotional/behavioral swings during the COVID-19 pandemic

The normal day-to-day lives of adolescents have changed significantly over the past 18 months during the COVID-19 pandemic. Their routine behaviors, eg, meeting and interacting with friends, participating in sports, the anticipated experience by adolescents of ‘newfound’ freedoms, the excitement of entering high school, preparing to enter schools of higher education, and/or a first job have all been either put on hold or significantly altered during the pandemic.

Most adolescents have experienced at least some form of virtual education throughout the COVID-19 pandemic. For many, their first return to a classroom, either high school or college, will be this Fall 2021 semester. However, for high school students, return to school may be impacted by the current community spread of the Delta variant in areas of the country that have a high number of unvaccinated populations. How has virtual education impacted the totality of adolescent growth and development experiences? We do not have the answer to this question, as yet. Many pediatric providers schedule extra time for the annual adolescent visit. Today, this extended time for the visit is more critical than ever, to allow time to talk with the adolescent, identify real or potential emotional and/or behavioral health problems and make sustainable plans to assure the adolescent is on the path to healthy behaviors.

What about adolescents who lost a parent, sibling, relative, or friend to COVID-19?

On July, 20, 2021, the National Institute of Health published a news release based on a published research studyrevealing that 1.5 million children around the world lost a primary or secondary caregiver due to the COVID-19 pandemic.

 The United States was identified as 1 of 6 countries with the highest numbers of children who lost their parent or primary caregiver during the pandemic. As pediatricians and pediatric nurse practitioners, it is essential to consider the loss of a parent by an adolescent and the influences and possible consequences of this loss on the adolescent emotional and behavioral development. Has the adolescent even had time to grieve the loss of their parent or caregiver? Who is now supporting the adolescent? Has the adolescent received counseling for their loss? How is the adolescent coping with the loss? This is a critical time to administer and interpret validated screening tools, such as the Patient Health Questionnaires (PHQ-2

 or the Screen for Child Anxiety Related Disorders (SCARED) tool,

 during each of the office visits. These tools will help to identify the emotional and behavioral status of adolescents who have lost a parent, and to implement evidence-based treatment plans to help the adolescent cope and emerge mentally and physically healthy. In addition, as Dr. Jellinek discusses, it is also essential to screen for suicide ideation in adolescents and even more so, for adolescents who have lost a parent or primary caregiver during this pandemic. The mental health, emotional and behavioral health of our adolescents must addressed in each primary care encounter.

1. Hillis S, Unwin H, Chen Y et al. Global minimum estimates of children affected by COVID-19-associated orphanhood and deaths of caregivers: a modelling study. 

. July 20, 2021. Epub ahead of print. doi:10.1016/s0140-6736(21)01253-8

2. National Institute of Health. New Release: More than 1.5 million children lost a primary or secondary caregiver due to the COVID-19 pandemic

Published July 20, 2021. Accessed July 20, 2021.

 https://www.nih.gov/news-events/news-releases/more-15-million-children-lost-primary-or-secondary-caregiver-due-covid-19-pandemic

3. American Psychological Association. Patient Health Questionnaire (PHQ-9 & PHQ-2). Accessed July 22, 2021.

 https://www.apa.org/pi/about/publications/caregivers/practice-settings/assessment/tools/patient-health

4. The CRAFFT Questionnaire (version 2.0). Accessed July 22, 2021.

 https://njaap.org/wp-content/uploads/2018/03/COMBINED-CRAFFT-2.1-Self-Admin_Clinician-Interview_Risk-Assess-Guide.pdf

5. Generalized anxiety disorder GAD-7. Accessed July 22, 2021. 

http://www.medi-mouse.com/graphics/GAD7.pdf

6 .Screen for child anxiety related disorders (SCARED). Accessed July 21, 2021.

 https://projectteachny.org/wp-content/uploads/2017/09/SCARED_child.pdf

Adolescence is often a time when a teenager swings between maturity and childish behavior. This already fraught period has been exacerbated by the effects of the pandemic as well.

Understanding the perplexing adolescent years

Guidelines currently recommend administering intravenous magnesium sulfate for refractory pediatric asthma in the emergency department, but hospitalization rates tied to asthma have been stable. An 

 looked at whether receiving intravenous magnesium sulfate therapy was linked to subsequent hospitalization.

Investigators performed a post hoc secondary analysis of a double-blind randomized clinical trial of children who had acute asthma and were treated from September 2011 to November 2019 in 7 Canadian tertiary care pediatric emergency departments. Children with Pediatric Respiratory Assessment Measure scores that were 5 points or higher following an initial treatment with systemic corticosteroids and inhaled albuterol with ipratropium bromide were randomized to either receive 3 nebulized treatments of albuterol plus intravenous magnesium sulfate (40-75 mg/kg) or 3 nebulized treatments of albuterol plus an intravenous 5.5% saline placebo.

There were 816 children included in the study of which 364 were hospitalized. There were 215 children who were given intravenous magnesium sulfate, of which 190 were hospitalized. By comparison only 174 of the 601 children who did not get intravenous magnesium sulfate were hospitals. Factors linked to hospitalization included an increase in Pediatric Respiratory Assessment Measure score at disposition (per 1-U increase: odds ratio [OR], 2.24; 95% CI, 1.89-2.65; 

 < .001), utilization of additional albuterol (OR, 5.94; 95% CI, 3.52-10.01; 

 < .001), and receiving intravenous magnesium sulfate from 2011 to 2016 (OR, 22.67; 95% CI, 6.26-82.06; 

 < .001) as well as from 2017 to 2019 (OR, 4.19; 95% CI, 1.99-8.86; 

 < .001). Administration of intravenous magnesium sulfate was linked to hospitalization in children who had a disposition Pediatric Respiratory Assessment Measure score of 3 or lower (OR, 8.52; 95% CI, 2.96-24.41; 

The investigators concluded that after adjusting for patient-level characters that receiving intravenous magnesium sulfate therapy after an initial asthma treatment in the emergency department was linked to subsequent hospitalization and existed even among children with mild asthma at emergency department disposition.

1. Schuh S, Freedman S, Zemek R, et al. Association between intravenous magnesium therapy in the emergency department and subsequent hospitalization among pediatric patients with refractory acute asthma. 

. 2021;4(7):e2117542. doi:10.1001/jamanetworkopen.2021.17542

Intravenous (IV) magnesium sulfate is recommended for treating refractory pediatric asthma, but is it linked to consequent hospitalization?

Does IV magnesium treatment for asthma lead to hospitalization?

New report guides pediatricians on offering sexual education to children with disabilities

A guideline update from the American Academy of Pediatrics offers help to clinicians in guiding children and teenagers with disabilities through sexual development.

Using patient portals to improve flu shot rates

Patient portals can be a powerful communication tool for both clinician and family, but can they also be used to improve uptake of the annual influenza vaccine?

It was a very busy week for the Contemporary Pediatrics team.

In case you missed it: July 26 to July 30

The first 1000 days of a child’s life has become increasingly seen as a crucial time to shape lifelong health outcomes and habits. This may be particularly true with regards to nutrition, as the period sets dietary habits and cover key points in brain development. An 

 was used to see how it would impact the prevalence of an overweight infant as well as the mother’s postpartum weight retention and care.

The investigators examined the effects of the First 1000 Days program among 995 term, low-income infants as well as their mothers who received care at 2 intervention community health centers. There were 650 infant/mother pairs at 2 comparison health centers for control purposes. The pairs in the control arm received usual care. At the intervention centers, there was staff training, health, and behavioral screening, patient navigating, educational materials, health coaching, growth tracking, and text messaging. Infants were assessed at 6 and 12 months of age. 

The average birth weight was 3.34 kg. Two-thirds of the infant/mother pairs were publicly insured. At 6 months, the infants in intervention group had lower weight-for length 

 scores (β: −.27; 95% CI: −.39 to −.15) as well as lower odds of overweight (adjusted odds ratio [OR]: 0.46; 95% CI: 0.28 to 0.76) than the infants who were seen at the comparison sites. These differences were maintained through the 12 month assessment (z score β: −.18; 95% CI: −.30 to −.07; adjusted OR for overweight: 0.60; 95% CI: 0.39 to 0.92). Mothers who were part of the intervention program were found to have lower weight retention, noted as nonsignificant, when they were seen 6 weeks’ postpartum (β: −.51 kg; 95% CI: −1.15 to .13). Furthermore, the mothers had higher odds of having a postpartum visit than the mothers in the control sites.

The investigators concluded that the intervention, when used in combination with coaching appeared to be linked to improvements in both maternal postpartum care as well as infant weight status.

1. Taveras E, Perkins M, Boudreau A, et al. Twelve-Month outcomes of the first 1000 days program on infant weight status. 

. July 29, 2021. Epub ahead of print. doi:10.1542/peds.2020-046706

The first months of life set the course of a child’s health. How effective is an intervention at improving weight outcomes in the infant and use of postpartum care by the mother?

“First 1000 day” intervention improves newborn weight status

For children with systemic juvenile idiopathic arthritis, steroids have long been one of the only available treatments, despite the fact that they can increase the risk of infection and impede growth. The introduction of biologic therapies over the past few years has offered a new way to treat the condition without those adverse effects. A 

 examined how early initiation of biologic therapy impacted the use of glucocorticoids.

The investigators performed an emulated pragmatic trial that used observational data from children who had been hospitalized with new-onset systemic juvenile idiopathic arthritis. The Pediatric Health Information System was used to determine diagnostic and billing records. Glucocorticoid exposure during the index hospitalization was found through an inpatient billing code for oral or intravenous dexamethasone, hydrocortisone, methylprednisolone, prednisolone, or prednisone. Biologic therapy included anakinra, rilonacept, canakinumab, or tocilizumab.

A total of 468 children met the eligibility criteria for the study. Among this cohort, 19% of the patients had a billing code for biologic therapy without either preceding or concurrent initiation of immunomodulatory medications. The proportion saw significant increase over the study period from 2008 to 2019, reaching 40% of all patients discharged between 2017 and 2019. Median time to initiate a biologic therapy from admission was 4 days. For glucocorticoids, it was 5 days. Overall 51.3% of patients were given glucocorticoids, including 22.5% who were administered at least 1 dose of pulse dose glucocorticoids. Once glucocorticoids were started in patients, nearly all of them continued receiving them until they were discharged. Additionally, exposure to methotrexate was more common in patients who did not initiate biologics versus those who initiated them (8.6% vs 2.8%, 

= 0.09). The most common biologic therapy used was anakinra, which was initiated in 69 patients. Canakinumab was used in 1 patient and tocilizumab was used another patient.

The investigators concluded that not only has the use of biologic therapy with new-onset systemic juvenile idiopathic arthritis increased meaningfully over the past decade, but this shift in treatment appeared to be linked to less exposure to glucocorticoids. They believe that this increase in biologics could lead to clinically relevant reductions in adverse effects tied to the use of glucocorticoids.

1. Peterson R, Xiao R, Katcoff H, Fisher B, Weiss P. Effect of first-line biologic initiation on glucocorticoid exposure in children hospitalized with new-onset systemic juvenile idiopathic arthritis: emulation of a pragmatic trial using observational data. 

. 2021;19(1)109. doi:10.1186/s12969-021-00597-z

Treatment for systemic juvenile idiopathic arthritis (sJIA) has long included steroids, but biologics now offer new ways to treat. Does early initiation of biologic therapy lead to a lessening in steroid use?

 Reducing steroid use with sJIA

Patient portals in electronic health records are a helpful way for patients and families to have beneficial information about diagnoses and prescriptions. The portal is also a helpful tool for clinicians and families to communicate with one another. A 

 looked at whether using the portal to remind parents about influenza vaccines had a positive impact on vaccination rates.

The investigators performed an intention-to-treat randomized clinical trial in children aged 6 months to <18 years who were seen in 1 of 53 primary care practices. Patients or their parent/proxy who were considered active portal users were randomly assigned to 1 of 2 groups: receive reminder messages that were framed as gains or losses or receive no messages. The participants were also separately randomized to receive a precommitment message before the start of the influenza season. The administration of ≥1 seasonal influenza vaccinations were considered primary outcomes. Among patients aged 6 months to < 3 years who needed a second influenza vaccine dose, participants were randomized to either receive a message reminding the parent about the second dose or receiving no reminder.

There were 22,046 children included in the study. In the main control group, the vaccination rate was 56.9%. Within the intervention groups, the rate was 58.0% in the loss-frame reminders group (

 = .07), and 58.0% in the gain-frame group (

 = .47). When looking at the precommitment messaging, the investigators found that the rate was 58.3% in the precommitment group versus 57.0% in the control group (P = .11). Furthermore, the adjusted risk ratio for precommitment messaging was 1.02 (95% CI: 1.00–1.04) versus the control and 1.01 (95% CI: 0.98–1.05) for gain-frame reminders as well as 1.02 (95% confidence interval [CI]: 1.00–1.04) for loss-frame reminders. For the subset of children who required a second dose, the second-dose vaccination rates were 55.0% in the intervention group and 44.1% in the control group and had an adjusted risk ratio of 1.25 (95% CI: 1.07–1.45).

The investigators concluded that using patient portal reminders for influenza vaccines had no impact on first-dose influenza vaccination rates. However, the use of reminders was found to be an effective way to get young children back into the office for their second dose of the influenza vaccine.

1. Lerner C, Albertin C, Casillas A, et al. Patient portal reminders for pediatric influenza vaccinations: a randomized clinical trial. 

. July 28, 2021. Epub ahead of print. doi:10.1542/peds.2020-048413

Rachael Zimlich is a freelance writer in Cleveland, Ohio. She writes regularly for Contemporary Pediatrics, Managed Healthcare Executive, and Medical Economics.

Navigating developmental milestones can be difficult in children of all ages and abilities. In children with disabilities, this can become even more challenging depending on their physical, cognitive, or social capabilities—especially when it comes to sexual development.

A recent clinical report on healthy sexual development in children with disabilities aims to serve as a blueprint for pediatricians to help their patients and caregivers through the process. The 

 is an update to a guideline the American Academy of Pediatrics’ Council on Children with Disabilities released in 2006 on promoting healthy sexuality in children with disabilities. The updated report focuses on guidance for appropriate education, monitoring for a lack of coercion or violence in any sexual activity, and whether the child has reached the appropriate developmental level to navigate feelings and choices about sexual health. Pediatricians can be a resource for children and other teenagers to help them prepare for changes that are about to come, but preparation for patients and their families is usually lacking in this area.

“Children and teenagers with disabilities, just like all children and teenagers benefit from guidance from pediatricians on how to develop a healthy sexuality. We know that children and teenagers with disabilities are not receiving the sexual education they need, so pediatricians have a great opportunity to help bridge the knowledge gap for children and teenagers with disabilities and their families,” says Amy J. Houtrow, MD, PhD, MPH, lead author of the clinical report. Houtrow is a physical medicine and rehabilitation physician at the University of Pittsburgh Medical Center in Pennsylvania.

The updated report addresses a number of advances in the understanding of children with disabilities that have occurred over the last decade. This new knowledge is a combination increased understanding of disabilities like autism spectrum disorder, as well as the fact that many people with disabilities are living longer lives. At the same time as understanding of sexual health in children with disabilities is increasing, the report notes, formal education in school is decreasing and being replaced by media influences.

The primary focus of the report is to arm pediatricians with evidence-based guidance for promoting health sexual activity and development regardless of physical, cognitive, or social limitations. More than 10 million children in the United States have some sort of development disability and navigating their sexual health and development can be a challenge for the parents, pediatricians, and most of all the children themselves.

“As is true for everyone, it is important that individuals with disabilities be provided experiences to acquire developmentally appropriate, relevant, and accurate sexual health knowledge to become competent,” the report authors suggest. “Youth with disabilities need regular opportunities to develop and use skills for negotiating sexual desire, intimacy, and activity that supports healthy sexuality while limiting negative outcomes of sexual activity—such as sexually transmitted infections [STIs], unintended pregnancy or sexual coercion, violence, abuse, or exploitation) regardless of their intellectual capacity.”

Houtrow says the guide utilizes a strength-based approach that emphasizes self-determination and assets to help pediatricians better frame dialogues with children and their families about sexual health.

“Often times we fall back on providing too little information because we underestimate someone’s ability to understand or their interest to learn or their emerging desires, thoughts and feelings,” Houtrow says. “We also know that not discussing risks doesn’t mean that the risks aren’t there. Pediatricians should be playing the long game, so to speak. They can start dialogues about developing a healthy sexuality in early childhood.”

Discussing healthy sexual development “early and often” is a wise approach, she says, and helps set the stage for anticipatory guidance provided over time.

“The tools we have available to us for educating about sexuality are geared toward certain ages or developmental stages. We can adapt these tools for children and teenagers with disabilities, as well,” she explains. “For the pediatrician who is unsure of the cognitive capabilities of one of their patients, the child’s school and parents can often fill in the gaps.”

Houtrow gives the example of children who are non-verbal but have good receptive skills. They may understand language much better than they are able to express. Pediatricians should always be mindful when providing education to children with disabilities to ask how the child best learns and understands so they can tailor dialogue and guidance accordingly.

Another challenge in offering this guidance is trying to decide if parents should be involved. Hourtrow says the answer to this question depends on the child and the parent/pediatrician/patient relationship.

“If the pediatrician is repeatedly engaging in discussions throughout childhood, those early discussions should be with a parent present. Some children will want a private discussion, which should be offered,” Houtrow explains. “As recommended in Bright Futures, private discussions without the parent or guardian present in the teen years can be provided to most children with disabilities. Discussions with the family present should still occur, but the character and content of those discussions can differ. Having private discussions with teens with disability can help develop their autonomy and sense of self. There are circumstances where private discussions don’t make sense, but those are likely more rare than we think.”

Other topics covered in the guide include how and when to start discussion—usually around 8 or 9 years of age—and how to provide screening for STIs and advice on contraception, the report notes. Assessing for sexual abuse, assault, and coercion is also important, and pediatricians need to help parents and caregivers understand the increased risk children with disabilities have in this regard.

Houtrow says she hopes the guide will help pediatricians more effectively—and more comfortably—address these challenging issues in a very vulnerable population.

“I hope that more children and teenagers with disabilities receive helpful guidance about developing a healthy sexuality to help them flourish. I hope that pediatricians can help destigmatize sexuality and disability—many people erroneously assume that people with disabilities are non-sexual beings,” Houtrow says. “The pediatrician can be a great ally for all children and youth including those with disabilities. This is especially important for LGBTQ+ children and teenagers with disabilities.”

Houtrow adds that she is optimistic that these advances may also result in better outcomes in terms of sexual abuse prevalence, pregnancy rates, and STIs among children with disabilities.

“I hope that adults with disabilities report that the guidance from their pediatricians helped them develop their sexual autonomy, I hope that children and teenagers with disabilities have the supports they need to foster a healthy sexuality for themselves,” she says.

1. Houtrow A, Elias E, Davis B, COUNCIL ON CHILDREN WITH DISABILITIES. Promoting healthy sexuality for children and adolescents with disabilities. 

. 2021;148(1):e2021052043. doi:10.1542/peds.2021-052043