Adults

Population Pharmacokinetics of Meropenem Across the Adult Lifespan

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • February 2025

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Boutzoukas AE, Balevic SJ, Hemmersbach-Miller M, Winokur PL, Gu K, Chan AW, Cohen-Wolkowiez M, Conrad T, An G, Kirkpatrick CMJ, Swamy GK, Walter EB, Schmader KE, Landersdorfer CB.

This study conducted an opportunistic pharmacokinetic study to evaluate the population pharmacokinetics of meropenem, an antimicrobial commonly used to treat Gram-negative infections in adults of different ages, including older adults, and determined optimal dosing regimens. Meropenem dosing should be based on renal function rather than age. For patients without renal impairment, extended infusion may increase the probability of target attainment.

 

Predictors of Potentially Inappropriate Stimulant Prescribing Among Adults

Posted on by Kayla Korzekwinski

Pharmacoepidemiology and Drug Safety • January 2025

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Thakkar PV, Boutzoukas AE, Compton SN, Sivashankar O, Zimmerman KO, Benjamin DK Jr, Brookhart MA

Increases in adult stimulant prescribing pose a potential risk due to the higher prevalence of contraindicated conditions among this population. This study sought to identify patient, provider, and visit characteristics predictive of potentially inappropriate adult stimulant prescriptions. The proportion of potentially inappropriate adult stimulant prescriptions increased over time and with patient age. Visits to primary care providers were predictive of potentially inappropriate prescribing, and a history of substance abuse was predictive of new stimulant prescriptions; therefore, quality improvement interventions regarding safe stimulant prescribing practices may be warranted.

Mentorship

Posted on by Kayla Korzekwinski

Journal of the Pediatric Infectious Diseases Society • December 2023

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Zimmerman KO

A unique feature of the Duke Summer Training in Academic Research (STAR) program is its focus on mentorship. STAR is an opportunity for junior faculty members and fellows to learn how to be mentors, and for undergraduate and high school students to learn how to be mentored. These are important and fundamental points; mentorship, from the perspective of mentor or mentee, should be a deliberate and skilled activity that can result from adequate training.

Duke STAR Program

Posted on by Kayla Korzekwinski

Journal of the Pediatric Infectious Diseases Society • December 2023

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Benjamin DK Jr

The DCRI Pediatrics group designed a summer internship program that had a wide reach and reflects its purpose and mission to conduct research to help children everywhere. This led to the creation of the Duke STAR (Summer Training in Academic Research) Program, a program that provides ~20 high school or college students per summer the opportunity to be exposed to clinical research and to work closely with researchers and practicing clinicians. Recruiting efforts prioritized participants from historically marginalized communities in North Carolina, with a goal to include at least several students each year who were “hidden talent.”

Trends in Pediatric Emergency and Inpatient Healthcare Use for Mental and Behavioral Health Among North Carolinians During the Early COVID-19 Pandemic

Posted on by Kayla Korzekwinski

Journal of the Pediatric Infectious Diseases Society • December 2023

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Sielaty R, Boutzoukas AE, Zimmerman KO, Caison B, Charles CO, CoyneSmith T, Darden T, Overman RA, Benjamin, Jr DK, Brookhart MA

Widespread school closures and health care avoidance during the COVID-19 pandemic led to disruptions in access to pediatric mental health care. This study conducted a retrospective analysis of emergency and inpatient administrative claims from privately insured children aged 6-20 years in North Carolina between January 2019 and December 2020.

Population Pharmacokinetics of Piperacillin/Tazobactam Across the Adult Lifespan

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • January 2023

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Hemmersbach-Miller M, Balevic SJ, Winokur PL, Landersdorfer C, Gu K, Chan AW, Cohen-Wolkowiez M, Conrad T, An G, Kirkpatrick C, Swamy GK, Walter EB, Schmader KE

Piperacillin/tazobactam is one of the most frequently used antimicrobials in older adults. Using an opportunistic study design, we evaluated the pharmacokinetics of piperacillin/tazobactam as a probe drug to evaluate changes in antibacterial drug exposure and dosing requirements, including in older adults.

Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure-Response

Posted on by Kayla Korzekwinski

Journal of Clinical Pharmacology • January 2023

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Balevic SJ, Niu J, Chen J, Green D, McMahon A, Hornik CP, Schanberg L, Glaser R, Doddapaneni S, Gonzalez D, Burckart GJ

To streamline drug development, the United States Food and Drug Administration (FDA) can consider the extrapolation of adult efficacy data to children when the disease and drug effects are sufficiently similar. This study explored whether the relationship between drug exposure and response for selected drugs in systemic lupus erythematosus (SLE) was sufficiently similar to support a consideration of the extrapolation of adult efficacy data to children of ≥5 years of age.

Developing lay summaries and thank you notes in paediatric pragmatic clinical trials

Posted on by Kayla Korzekwinski

Health Expectations • June 2022

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Zimmerman KO, Perry B, Nsonwu A, Hanlen-Rosado E, Lane MD, Benjamin DK Jr., Becker M, Corneli A; on behalf of the Best Pharmaceuticals for Children Act — Pediatric Trials Network Steering Committee
This study conducted formative research to assess the acceptability of lay summaries and thank you notes, as well as to refine and expand guidance on participant and family engagement in Pediatric Trials Network’s (PTN) pragmatic paediatric clinical research. Researchers conducted in-depth qualitative interviews with adolescent clinical trial participants and caregivers of paediatric participants in four trials conducted by PTN across eight sites. This is the first study to describe stakeholder preferences for thank you note content and layout. Using these findings, researchers finalized PTN’s trial communication guidance for use in future PTN trials.

Impact of Personal Protective Equipment on the Performance of Emergency Pediatric Tasks

Posted on by Kayla Korzekwinski

Pediatric Emergency Care • December 2021

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Adler MD, Krug S, Eiger C, Good GL, Kou M, Nash M, Henretig FM, Hornik CP, Gosnell L, Chen JY, Debski J, Sharma G, Siegel D, Donoghue A
This study evaluated the impacts of personal protective equipment (PPE) on timeliness or success of emergency procedures performed by pediatric health care providers (HCPs). For session 1, HCPs wore normal attire; for session 2, they wore full-shroud PPE garb with 2 glove types: Ebola level or chemical. During each session, they performed clinical tasks on a patient simulator: intubation, bag-valve mask ventilation, venous catheter (IV) placement, push-pull fluid bolus, and defibrillation. Personal protective equipment did not affect procedure timeliness or success on a simulated child, with the exception of IV placement. Further study is needed to investigate PPE’s impact on procedures performed in a clinical care context.

Evaluating Site-Level Implementations of the HL7 FHIR Standard to Support eSource Data Exchange in Clinical Research

Posted on by Kayla Korzekwinski

Studies in Health Technology and Informatics • May 2021

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Garza MY, Eisenstein E, Kumar KR, Zimmerman KO, Zozus M
Direct extraction and use of electronic health record (EHR) data is a long-term and multifaceted endeavor. A systematic mapping of study data elements was used to measure the coverage of the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard for a federally sponsored, pragmatic cardiovascular randomized controlled trial (RCT) targeting adults. Researchers evaluated site-level implementations of the HL7® FHIR® standard to investigate study- and site-level differences that could affect coverage and offer insight into the feasibility of a FHIR-based eSource solution for multicenter clinical research.