Assessment of primary outcome measures for a clinical trial of pediatric hemorrhagic injuries.

ABSTRACT:

Objective

We 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.

Methods

We 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.

Results

73 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 ag

SUBMITTER: Nishijima DK 

PROVIDER: S-EPMC7483869 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature