Identification and Evaluation of Controlled Trials in Pediatric Cardiology: Crowdsourced Scoping Review and Creation of Accessible Searchable Database

Abstract Cardiac disease in children is associated with significant morbidity and mortality as well as increased health resource utilization. There is a perception that there is a paucity of high-quality studies, particularly randomized controlled trials (RCTs), in the field of pediatric cardiology. We sought to identify, examine, and map the range of RCTs conducted in children with cardiac conditions, including the development of a searchable open-access database. A literature search was conducted encompassing MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from inception to 2018. All English-language RCTs enrolling children (age 0-21 years) with cardiac conditions were included. Data extraction and risk of bias assessments were performed in duplicate via crowdsourcing for each eligible study and entered into an online database. A total of 933 RCTs met eligibility criteria. Median trial recruitment was 49 patients (IQR: 30–86) with 18.9% of studies (N=176) including more than 100 patients. A wide variety of populations and interventions were encompassed with congenital heart disease (79.8% of RCTs) and medications (63.3% of RCTs) often studied. Just over half of the trials (53.4%) clearly identified a primary outcome while less than half (46.6%) fully documented a robust randomization process. Trials were summarized in a searchable online database ( https://pediatrics.knack.com/cardiology-rct-database#cardiology-rcts/ ). Contrary to a commonly held perception, there are nearly 1,000 published RCTs in pediatric cardiology. The open-access database created as part of this project provides a resource that facilitates an efficient, comprehensive review of the literature to clinicians and researchers caring for children with cardiac issues.