Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports.

Background And Objective: Upadacitinib is indicated for diseases affecting persons of childbearing potential including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis; however, teratogenicity was observed in animal studies. Given the potential for human fetal risk, pregnancy avoidance measures were required during clinical trials. This analysis describes pregnancy outcomes in patients exposed to upadacitinib during pregnancy.

Hospital Discharge Instructions: Characteristics, Accessibility, and National Guideline Adherence.

Objectives: The content of pediatric hospital discharge instructions is highly variable. This study aimed to describe the characteristics, accessibility per patient literacy level and language, and national guideline adherence of pediatric hospital discharge instructions.

Methods: This retrospective study assessed discharge instructions at a tertiary children's hospital.

Interactive Inpatient Asthma Education: A Randomized Controlled Trial.

Background And Objectives: Inpatient asthma education interventions provide benefit compared with usual care, but evaluation of the most effective educational model is needed. We compared the impact of interactive versus didactic inpatient pediatric asthma education on subsequent emergency department (ED) visits and hospitalizations.

Methods: Children (aged 2‒16) with asthma admitted to a tertiary care children's hospital with an asthma exacerbation between October 2016 and June 2017 were randomly assigned to interactive or didactic (control) asthma education.

SCN2A-Developmental and Epileptic Encephalopathies: Challenges to trial-readiness for non-seizure outcomes.

Objective: SCN2A-associated developmental and epileptic encephalopathies (DEEs) present with seizures, developmental impairments, and often both. We sought to characterize the level and pattern of development in children with SCN2A variants, and to address the sensitivity of the Vineland Adaptive Behavior Scales (VABS) in measuring changes over time in children with SCN2A-DEEs.

Methods: Clinical histories for participants with pathogenic SCN2A variants in the Simons SearchLight project were analyzed for descriptive purposes.

Comparison of Two Assessment Tools for Hospitalized Subjects With Asthma.

Background: Pediatric Asthma Assessment tools used to guide the weaning of inhaled therapies during inpatient hospitalization require further evaluation and validation. This study aimed to compare 2 asthma assessment tools: an asthma scale versus an asthma score.

Methods: A prospective, physician-blinded, comparison study was conducted in 2 separate 6-week phases of patients > 2 y old admitted to a tertiary care children's hospital with status asthmaticus between July and November 2014.

Natural history of burnout, stress, and fatigue in a pediatric resident cohort over three years.

Background: Burnout is known to be high amongst physician trainees. Factors such as stress, fatigue, social environment, and resilience could affect burnout. Cross-sectional data describe burnout in pediatric residents, but the trajectory of burnout in a cohort of residents followed longitudinally through the full course of residency training has not been reported.

The Importance of Engaging Children in Research Decision-Making: A Preliminary Mixed-Methods Study.

Studies demonstrate deficiencies in parents' and children's comprehension of research and lack of child engagement in research decision-making. We conducted a cross-sectional and interview-based study of 31 parent-child dyads to describe decision-making preferences, experiences, and comprehension of parents and children participating in research. Parents and children reported that parents played a greater role in decisions about research participation than either parents or children preferred.

Low prevalence of clinical decision support to calculate caloric and fluid intake for infants in the neonatal intensive care unit.

Background: Clinical decision support (CDS) improves nutrition delivery for infants in the neonatal intensive care unit (NICU), however, the prevalence of CDS to support nutrition is unknown.

Methods: Online surveys, with telephone and email validation of responses, were administered to NICU clinicians in the Children's Hospital Neonatal Consortium (CHNC). We determined and compared the availability of CDS to calculate calories and fluid received in the prior 24 h, stratified by enteral and parenteral intake, using McNemar's test.

Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials.

Background: Endometriosis profoundly impairs women's workplace and household productivity.

Objective: The aim of this study was to evaluate the impact of elagolix on endometriosis-related workplace and household productivity losses.

Methods: Data were pooled from two phase III trials of women aged 18-49 years with moderate to severe endometriosis-associated pain treated for 6 months with elagolix 150 mg daily (QD), 200 mg twice daily (BID), or placebo.

Ideal vs. real: a systematic review on handling covariates in randomized controlled trials.

Background: In theory, efficient design of randomized controlled trials (RCTs) involves randomization algorithms that control baseline variable imbalance efficiently, and corresponding analysis involves pre-specified adjustment for baseline covariates. This review sought to explore techniques for handling potentially influential baseline variables in both the design and analysis phase of RCTs.

Methods: We searched PubMed for articles indexed "randomized controlled trial", published in the NEJM, JAMA, BMJ, or Lancet for two time periods: 2009 and 2014 (before and after updated CONSORT guidelines).

Critical Errors in Inhaler Technique among Children Hospitalized with Asthma.

Past studies have not evaluated inhaler use in hospitalized children with asthma. The objectives of this study were to evaluate inhaler technique in hospitalized pediatric patients with asthma and identify risk factors for improper use. We conducted a prospective cross-sectional study in a tertiary children's hospital for children 2-16 years of age admitted for an asthma exacerbation, and inhaler technique demonstrations were analyzed.

A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Identification of Efficient and Cost-Effective Methods for Decision Making (Part 2).

Background: The ability to successfully recruit participants for electronic health (eHealth) clinical trials is largely dependent on the use of efficient and effective recruitment strategies. Determining which types of recruitment strategies to use presents a challenge for many researchers.

Objective: The aim of this study was to present an analysis of the time-efficiency and cost-effectiveness of recruitment strategies for eHealth clinical trials, and it describes a framework for cost-effective trial recruitment.

A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Simple Architecture (Part 1).

Background: The ability to identify, screen, and enroll potential research participants in an efficient and timely manner is crucial to the success of clinical trials. In the age of the internet, researchers can be confronted with large numbers of people contacting the program, overwhelming study staff and frustrating potential participants.

Objective: This paper describes a "do-it-yourself" recruitment support framework (DIY-RSF) that uses tools readily available in many academic research settings to support remote participant recruitment, prescreening, enrollment, and management across multiple concurrent eHealth clinical trials.

Use of Metformin for Weight Management in Children and Adolescents With Obesity in the Clinical Setting.

Use of metformin for weight loss for children in a clinical setting has not been well described; therefore, we aimed to identify characteristics of obese patients prescribed metformin in a clinical setting and evaluate changes in anthropometric measures. Records of obese patients aged 10 to 18 years without diabetes attending an academic endocrinology practice from 2009 to 2013 were reviewed. Analyses assessed changes in anthropometric measures (weight, body mass index [BMI], and BMI z-score) over 12 months between those prescribed metformin (n = 49) and those not prescribed metformin (n = 142).

Energy and Protein Intake During the Transition from Parenteral to Enteral Nutrition in Infants of Very Low Birth Weight.

Objective: To evaluate the association between nutrition delivery practices and energy and protein intake during the transition from parenteral to enteral nutrition in infants of very low birth weight (VLBW).

Study Design: This was a retrospective analysis of 115 infants who were VLBW from a regional neonatal intensive care unit. Changes in energy and protein intake were estimated during transition phase 1 (0% enteral); phase 2 (>0, ≤33.

Ideal and Actual Impact of Rapid Diagnostic Testing and Antibiotic Stewardship on Antibiotic Prescribing and Clinical Outcomes in Children With Positive Blood Cultures.

Background: Implementing matrix-assisted laser desorption ionization-time of flight and multiplex polymerase chain reaction has been associated with decreased mortality and hospital length of stay in adults, but the impact in pediatrics is less understood.

Methods: This pre-post quasi-experimental study compared antibiotic prescribing for positive blood cultures in patients ≤21 years of age collected in 2012 (preintervention) and in 2015 (after matrix-assisted laser desorption ionization-time of flight/multiplex polymerase chain reaction). Time to effective and optimal antimicrobial therapy was evaluated using Cox proportional hazards regression.

Postoperative Pain Outcomes After Nuss Procedures: Comparison of Epidural Analgesia, Continuous Infusion of Local Anesthetic, and Preoperative Self-Hypnosis Training.

Background/purpose: The Nuss procedure to correct pectus excavatum is associated with severe postoperative pain. The purpose of this retrospective study was to compare pain management outcomes of thoracic epidural analgesia and continuous infusion of local anesthetic (CILA) with and without preoperative self-hypnosis training (SHT) after Nuss procedure (4 treatment groups).

Methods: Between February 2010 and December 2013, 24 of 53 adolescents who underwent Nuss procedure received SHT.

Vital signs analysis algorithm detects inflammatory response in premature infants with late onset sepsis and necrotizing enterocolitis.

Background: Nonspecific clinical signs and suboptimal diagnostic tests limit accurate identification of late onset sepsis (LOS) and necrotizing enterocolitis (NEC) in premature infants, resulting in significant morbidity and antibiotic overuse. An infant's systemic inflammatory response may be identified earlier than clinical suspicion through analysis of multiple vital signs by a computerized algorithm (RALIS).

Aim: To evaluate the revised RALIS algorithm for detection of LOS and NEC in preterm infants.

The relationship between sweat chloride levels and mortality in cystic fibrosis varies by individual genotype.

Rationale: The association between CFTR genotype, sweat chloride and mortality has been inconsistent, but no previous analyses have examined the association stratified by individual genotypes.

Objectives: To evaluate the genotype-specific association between sweat chloride and mortality.

Methods: The CFF Patient Registry was assessed and included all patients in the registry between 1996 and 2012 with at least one F508del allele.

Antibiotic duration and changes in FEV are not associated with time until next exacerbation in adult cystic fibrosis: a single center study.

Background: Pulmonary exacerbations (PEx) are a major driver of morbidity and mortality in cystic fibrosis and reducing their frequency by extending the time between them is an important therapeutic goal. Although treatment decisions for exacerbations are often made based on dynamic changes in lung function, it is not clear if these changes truly impact future exacerbation risk. We analyzed adults with chronic Pseudomonas aeruginosa infection to determine whether changes in FEV or duration of intravenous antibiotic therapy were associated with time to the next pulmonary exacerbation.

Association Between the 7-Day Moving Average for Nutrition and Growth in Very Low Birth Weight Infants.

Background: Very low birth weight (VLBW) infants remain at risk for postnatal growth restriction. Clinicians may have difficulty identifying growth patterns resulting from nutrition interventions, impeding prompt management changes intended to increase growth velocity. This study aimed to quantify the association between growth and nutrition intake through 7-day moving averages (SDMAs).