Grant: Knowledge Synthesis Grant

Child Health; Data Monitoring Committees; Methodology; Outcomes; Randomized Controlled Trials; Recruitment And Consent; Reporting; Risk Of Bias; Sample Size; Systematic Review

<html> <body> <b>Background:</b> High quality pediatric clinical research is a critical step in ensuring the best health for children. There are well-documented shortcomings in trials in child health, which may result in effective treatment being withheld, or children receiving ineffective or harmful treatment. There have been numerous initiatives worldwide to improve the quality of clinical research, but their impact on pediatric randomized controlled trials (RCTs) is unknown. Establishing the current state of pediatric trials is necessary to guide future knowledge translation (KT) efforts.<br> <br> <b>Objective:</b> To conduct a systematic review of the quality of pediatric clinical research, examining recently published randomized controlled trials conducted in children.<br> <br> <b>Methods:</b> We will follow established methodological standards for conducting systematic reviews. We will use <i>a priori</i> defined and well-accepted methods for searching the literature; study selection, including specific eligibility criteria with respect to study design and populations; data extraction; assessment of methodologic quality; data synthesis; and KT and dissemination. We will focus on areas identified as priorities for pediatric research by the international group Standards for Research in (StaR) Child Health (e.g., risk of bias, recruitment and consent, sample size, relevant subgroups and outcomes, data monitoring committees). We will include RCTs conducted in children (0-18 years of age), but will not restrict our sample by condition or intervention. We will synthesize data on measures of study quality, and where possible, will calculate effect estimates and determine their association with methodological rigor.<br> <br> <b>Team Members:</b> Our team includes members with extensive expertise in conducting both systematic reviews and clinical research in children. Our team comprises leaders in child health research methodology, representing a range of specialties including consent and recruitment; risk of bias; data monitoring committees and sample size; selection of appropriate outcomes; and age groups. We also have Knowledge Users that represent prominent initiatives dedicated to improving the quality of clinical research: the Maternal Infant Child &amp; Youth Research Network (MICYRN), StaR Child Health, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Initiative, the CONSORT (Consolidated Standards of Reporting Trials) Group, and the Women &amp; Children&rsquo;s Health Research Institute (WCHRI). These organizations will assist with 1) focusing the scope of the review to ensure relevance to end-users; and 2) interpretation, presentation, and dissemination of results to a widespread audience.<br> <br> <b>Knowledge Translation:</b> We will use an integrated KT approach involving methodological and clinical experts and key national and international organizations to ensure that the results are relevant and widely disseminated. Our Knowledge Users are involved in specific KT activities including development of educational activities and reporting guidelines. The results of this work will inform these initiatives.<br> <br> <b>Significance:</b> The results of this systematic review will provide a measure of the quality of current pediatric RCTs, a foundation for measures of change in quality over time, and guidance for the research agenda and educational efforts to continue to improve child health research. This work is essential in ensuring that children receive the best care based on the strongest evidence available.</body> </html>