Chen, Chen-Evaluating the quality of pilot RCT studies in pediatric urology with CONSORT (2019)

Evaluating the quality of pilot RCT studies in pediatric urology with CONSORT 

Dr. Forough Farrokhyar, The aim of this systematic review is to assess the quality of pilot randomized controlled trials (RCTs) in pediatric urology based on their adherence to the Consolidated Stands of Reporting Trials (CONSORT) checklist extension to pilot studies. All pilot studies published between 2005 and 2018 in pediatric urology were searched from MEDLINE and EMBASE. Studies included were reported in English,  conducted on humans,  relevant to at least one clinical intervention in pediatric urology,  and framed as pilot RCTs. Of the 1347 titles from the initial search,  70 remained after screening titles,  abstracts,  and full-texts of the studies. Studies were scored on each of the 13 criteria in the CONSORT statement extension to assess their quality,  which included evaluation of the pilot RCT randomization protocol,  appropriateness of outcomes,  and reported adverse effects. Screening of studies from the initial search and scoring of each screened pilot RCT were completed by two researchers independently,  and agreement statistics were performed to ensure consistency. From the lack of stringency in journal criteria for pilot RCTs and the misconceptions surrounding the purpose of a study framed to be pilot,  the quality of pilot RCTs in pediatric urology are often suboptimal. Due to the vast cost,  sample size,  and risk associated with RCTs,  researchers are recommended to first complete a pilot study assessing the feasibility of their RCT study design. Unfortunately,  suboptimal pilot RCT quality may therefore affect the implementation of future RCTs.