The Quality Of Cluster Randomized Controlled Trials Of Pediatrics Should Be Improved: An Integrative Literature Review

Background: The number of cluster Randomized Controlled Trials (cRCTs) have been increasing and application in pediatrics is also growing. However, we did not know the quality of cRCTs in pediatrics and no previous study has comprehensively analyzed cRCTs in pediatrics. To investigate the status of cRCTs in pediatrics and analyzed influencing factors of the methodological quality.Methods: Through a search of 10 highest-impact-factor journals from PEDIATRICS and MEDICINE, GENERAL & INTERNAL, we identified cRCTs published from 1 January 2015 to 7 June 2020. The associations between study factors and grade of ROB (Risk of Bias) quality were analyzed by Pearson’s chi-squared test.Results: A total of 73 cRCTs were included. For the number of cRCTs, it has fluctuated in the past five years. For the International Classification of Diseases Eleventh Revision (ICD-11), 34.2% cRCTs could not be classified, of which more focused on vaccines; 15.1% cRCTs were classified into "X Extension Codes", of which more focused on vaccines and school bullying. For research settings, studies were concentrated in schools, communities, hospitals, clinics, and kindergartens, of which schools (36.5%) were the most. The number of clusters ranged from 1 to 1533 (M=28) and the participants ranged from 135 to 190,238 (M=1903). For the results of ROB assessment, 31 cRCTs were in high-quality, 28 were in low-quality, and 14 were unclear. The majority of cRCTs provided flow diagrams (87.8%), registered (98.6%), and made a distinction between primary and secondary outcomes (86.5%).Conclusions: The further improvement of the quality of cRCTs in pediatrics is needed, particularly in the terms of randomization, allocation concealment, and blinding. Writing and publishing the protocol can enhance transparency. Comply with of CONSORT statement for future studies is needed.