Critical Analysis of Consent Rates in Randomized Clinical Trials with Pediatric Patients: A Systematic Review

Methodology: Eligibility Criteria: For inclusion, studies had to be RCTs in pediatrics published between 2019-2026. Only studies that reported on the total sample size and informed consent rate were included. Studies published in the English language were included. Search Strategy: A systematic search was performed in PubMed, Cochrane, and CINHAL between 2019-2026. Search String: ("randomized controlled trial AND "informed consent) OR ("informed consent" AND "pediatrics") OR ("pediatrics" AND "clinical trials)). Screening and Selection of Studies: Two reviewers (Y.A.K. and A.K.) independently screened titles, abstracts, and full records, followed by a group meeting to arrive at a consensus. The studies reporting on pediatric RCTs from 2019 to 2026 were included if the informed consent rate was available and the total trial size was available. Data Extraction: Data extraction involved collecting information on study characteristics, including author details, publication year, country of trial execution, and relevant trial details. The primary outcomes extracted were the total number of trials and the rate of informed consent. Risk of bias Assessment: The risk of bias assessment of all included studies was performed by two reviewers independently using the revised Cochrane risk of bias tool (ROB 2) for randomized trials to minimize the risk of any potential bias in the study. The potential biases that were targeted included the randomization process, informed consent rates, and measurement of outcomes.