Operational efficiency

Assessing clinical site readiness for electronic health record (EHR)-to-electronic data capture (EDC) automated data collection

Posted on by Kayla Korzekwinski

Contemporary Clinical Trials • May 2023

Eisenstein EL, Zozus MN, Garza MY, Lanham HJ, Adagarla B, Walden A, Zimmerman KO, Kumar KR

 

eSource software is used to automatically copy a patient’s electronic health record data into a clinical study’s electronic case report form. However, there is little evidence to assist sponsors in identifying the best sites for multi-center eSource studies. This site developed an eSource site readiness survey. The survey was administered to principal investigators, clinical research coordinators, and chief research information officers at Pediatric Trial Network sites.

 

Impact of Personal Protective Equipment on the Performance of Emergency Pediatric Procedures by Prehospital Providers

Posted on by Kayla Korzekwinski

Disaster Medicine and Public Health Preparedness • May 2020

Kou M, Donoghue AJ, Stacks H, Kochman A, Semiao M, Nash M, Siegel D, Ku L, Debski J, Chen J-Y, Sharma G, Gosnell L, Krug S, Adler MD

This study examined the effects of personal protective equipment (PPE) on the ability of prehospital providers (PHPs) to perform resuscitation procedures on pediatric patients. This prospective study was conducted at a US simulation center. Paramedics wore normal attire at the baseline session and donned full Level B PPE for the second session. PPE did not have a significant impact on PHPs performing critical tasks while caring for a pediatric patient with a highly infectious or chemical exposure. This information may guide PHPs faced with the situation of resuscitating children while wearing Level B PPE.

Creation of a Multicenter Pediatric Inpatient Data Repository Derived from Electronic Health Records

Posted on by Kayla Korzekwinski

Applied Clinical Informatics Journal • March 2019

Hornik CP, Atz AM, Bendel C, Chan F, Downes K, Grundmeier R, Fogel B, Gipson D, Laughon M, Miller M, Smith M, Livingston C, Kluchar C, Heath A, Jarrett C, McKerlie B, Patel H, Hunter C; Best Pharmaceuticals for Children Act Pediatric Trials Network

 

Integration of electronic health records (EHRs) data across sites and access to that data remain limited. This study developed an EHR-based pediatric inpatient repository using nine U.S. centers from the National Institute of Child Health and Human Development Pediatric Trials Network.

 

Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience

Posted on by Kayla Korzekwinski

Contemporary Clinical Trials • March 2016.

England A, Wade K, Smith PB, Berezny K, Laughon M; Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee.

Performing drug trials in pediatrics is challenging. In support of the Best Pharmaceuticals for Children Act, the Eunice Kennedy Shriver National Institute of Child Health and Human Development funded the formation of the Pediatric Trials Network (PTN) in 2010. Since its inception, the PTN has developed strategies to increase both efficiency and safety of pediatric drug trials. Through use of innovative techniques such as sparse and scavenged blood sampling as well as opportunistic study design, participation in trials has grown. The PTN has also strived to improve consistency of adverse event reporting in neonatal drug trials through the development of a standardized adverse event table. We review how the PTN is optimizing operational efficiencies in pediatric drug trials to increase the safety of drugs in children.

Access article on PubMed.