• Daniel K Nishijima, Melissa Gosdin, Hiba Naz, Daniel J Tancredi, Hilary A Hewes, Sage R Myers, Rachel M Stanley, P David Adelson, Randall S Burd, Yaron Finkelstein, John VanBuren, T Charles Casper, Nathan Kuppermann, and TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN).
• Department of Emergency Medicine, UC Davis School of Medicine, 4150 V. Street, PSSB 2100, Sacramento, CA 95817, United States of America. Electronic address: dnishijima@ucdavis.edu.
• Am J Emerg Med. 2021 May 1; 43: 210-216.

ObjectiveWe evaluated the acceptability of the Pediatric Quality of Life Inventory (PedsQL) and other outcomes as the primary outcomes for a pediatric hemorrhagic trauma trial (TIC-TOC) among clinicians.MethodsWe conducted a mixed-methods study that included an electronic questionnaire followed by teleconference discussions. Participants confirmed or rejected the PedsQL as the primary outcome for the TIC-TOC trial and evaluated and proposed alternative primary outcomes. Responses were compiled and a list of themes and representative quotes was generated.Results73 of 91 (80%) participants completed the questionnaire. 61 (84%) participants agreed that the PedsQL is an appropriate primary outcome for children with hemorrhagic brain injuries. 32 (44%) participants agreed that the PedsQL is an acceptable primary outcome for children with hemorrhagic torso injuries, 27 (38%) participants were neutral, and 13 (18%) participants disagreed. Several themes were identified from responses, including that the PedsQL is an important and patient-centered outcome but may be affected by other factors, and that intracranial hemorrhage progression assessed by brain imaging (among patients with brain injuries) or blood product transfusion requirements (among patients with torso injuries) may be more objective outcomes than the PedsQL.ConclusionsThe PedsQL was a well-accepted proposed primary outcome for children with hemorrhagic brain injuries. Traumatic intracranial hemorrhage progression was favored by a subset of clinicians. A plurality of participants also considered the PedsQL an acceptable outcome for children with hemorrhagic torso injuries. Blood product transfusion requirement was favored by fewer participants.Copyright © 2020 Elsevier Inc. All rights reserved.

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