Applying Evidence From Clinical Trials: Need for Pediatric Learning Health System Research.

Abstract

* Abbreviations: MDD — : major depressive disorder PCOR — : Patient-Centered Outcomes Research RCT — : randomized controlled trial Nationally, the lifetime and 12-month prevalences of adolescent major depressive disorder (MDD) have been reported to be 11.7% and 8.2%, respectively.1,2 Recent data have also shown increases in prevalence from 2004 to 2015.3 These trends, coupled with a limited availability of pediatric and adolescent mental health specialists, have resulted in an increased demand for frontline pediatric providers to manage depression. Clinical management involves the use of pharmacological and psychotherapy interventions. Decisions on the most appropriate treatment course for a specific patient are typically based on the biomedical knowledge base composed of research studies as well as the judicious application of clinical experience and wisdom. Findings from randomized controlled trials (RCTs) that were rigorously performed and transparently reported in peer-reviewed medical journals are the most influential type of evidence, affecting both clinical decision-making and guideline development. The RCT has the reputation of being the gold standard for evidence generation because of its capacity to balance confounders (both measured and unmeasured) between groups, thereby strengthening the validity of treatment effect estimation. However, even this powerful study design has limitations of which practicing clinicians should … Address correspondence to Kamila B. Mistry, PhD, MPH, Agency for Healthcare Research and Quality, 5600 Fishers Ln, Room #06N03, Rockville, MD 20857. E-mail: kamila.mistry{at}ahrq.hhs.gov