6.119 SYSTEMATIC REVIEW OF OUTCOMES IN THE TREATMENT OF CHILDHOOD AND ADOLESCENT POSTTRAUMATIC STRESS DISORDER

Objectives: Core outcome sets are consensus-based, standardized sets of outcomes recommended for measurement across all clinical trials studying a particular condition. Currently, the diversity of outcomes and the differences in the methods used to measure them present challenges for systematic reviews of post-traumatic stress disorder. These challenges include the risk of selecting suboptimal outcomes due to inconsistencies in operational definitions across trials, discrepancies in approaches used for measurement, and an altogether omission of important outcomes. The use of core outcome sets mitigates these inconsistencies and leads to more consistent, meaningful research, limits reporting bias, and strengthens clinical decision making. Methods: We conducted a systematic review of registered trials examining post-traumatic stress disorder in children and adolescents to determine the outcome domains reported across studies and to determine the instruments used to measure these domains. We conducted a search of ClinicalTrials.gov to locate relevant studies examining post-traumatic stress disorder from January 1, 2008 to present using the child limiter. Our search produced 163 results. All primary and secondary outcomes, their associated measurement devices, and time frames were recorded for each study as well as relevant trial characteristics. Results: Descriptive statistics were tabulated for all variables in Stata 13. Our results suggest inconsistency in both outcome selection and measurement across trials. Furthermore, patient centered outcomes and adverse events were underreported. Conclusions: This study was the first phase toward the development of a core outcome set for post-traumatic stress disorder in children and adolescents. In future phases, consensus methodologies (such as the Delphi technique) could be used to narrow the set of outcomes found in our study.