Daniel K Nishijima1, Melissa Gosdin2, Hiba Naz3, Daniel J Tancredi4, Hilary A Hewes5, Sage R Myers6, Rachel M Stanley7, P David Adelson8, Randall S Burd9, Yaron Finkelstein10, John VanBuren11, T Charles Casper12, Nathan Kuppermann13. 1. 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. 2. Center for Healthcare Policy and Research, UC Davis School of Medicine, 2103 Stockton Blvd, Sacramento, CA 95817, United States of America. Electronic address: mmgosdin@ucdavis.edu. 3. Center for Healthcare Policy and Research, UC Davis School of Medicine, 2103 Stockton Blvd, Sacramento, CA 95817, United States of America. Electronic address: knaz@ucdavis.edu. 4. Department of Pediatrics, UC Davis School of Medicine, 2516 Stockton Blvd, Room 379, Sacramento, CA 95817, United States of America. Electronic address: djtancredi@ucdavis.edu. 5. Department of Pediatrics, Division of Pediatric Emergency Medicine, University of Utah School of Medicine, Primary Children's Hospital, 100 N. Mario Capecchi Dr., Salt Lake City, UT 84113, United States of America. Electronic address: hilary.hewes@hsc.utah.edu. 6. Department of Pediatrics, Division of Pediatric Emergency Medicine, Perelman School of Medicine at the University of Pennsylvania, Children's Hospital of Philadelphia, 3401 Civic Center Blvd., Philadelphia, PA 19104, United States of America. Electronic address: myerss@email.chop.edu. 7. Department of Pediatrics, Division of Pediatric Emergency Medicine, Ohio State University School of Medicine, Nationwide Children's Hospital, 700 Children's Dr., Columbus, OH 43205, United States of America. Electronic address: rachel.stanley@nationwidechildrens.org. 8. Department of Neurological Surgery, Barrow Neurological Institute at Phoenix Children's Hospital, 1919 E. Thomas Rd, Phoenix, AZ 85016, United States of America. Electronic address: dadelson@phoenixchildrens.com. 9. Division of Trauma and Burn Surgery, Children's National Medical Center, 111 Michigan Avenue NW, Washington, DC 20010, United States of America. Electronic address: rburd@childrensnational.org. 10. Department of Pediatrics, Divisions of Pediatric Emergency Medicine and Clinical Pharmacology & Toxicology, University of Toronto School of Medicine, Hospital for Sick Children, 555 University Ave., Toronto, ON M5G1X8, Canada. Electronic address: yaron.finkelstein@sickkids.ca. 11. Department of Pediatrics, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT 84108, United States of America. Electronic address: John.vanburen@hsc.utah.edu. 12. Department of Pediatrics, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT 84108, United States of America. Electronic address: Charlie.Casper@hsc.utah.edu. 13. Departments of Emergency Medicine and Pediatrics, UC Davis School of Medicine, 4150 V. Street, PSSB 2100, Sacramento, CA 95817, United States of America. Electronic address: nkuppermann@ucdavis.edu.
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 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. CONCLUSIONS: The 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.
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 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. CONCLUSIONS: The 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.
Authors: Daniel K Nishijima; John M VanBuren; Seth W Linakis; Hilary A Hewes; Sage R Myers; Matthew Bobinski; Nam K Tran; Simona Ghetti; P David Adelson; Ian Roberts; James F Holmes; Walton O Schalick; J Michael Dean; T Charles Casper; Nathan Kuppermann Journal: Acad Emerg Med Date: 2022-03-10 Impact factor: 5.221
Authors: John M VanBuren; T Charles Casper; Daniel K Nishijima; Nathan Kuppermann; Roger J Lewis; J Michael Dean; Anna McGlothlin Journal: Trials Date: 2021-11-04 Impact factor: 2.279