Selective Outcome Reporting Bias Is Highly Prevalent in Randomized Clinical Trials of Periodontology

Autor: Nathalia Vilela Souza, Alessandra Cardoso Nicolini, Isabella Neme Ribeiro Reis, Daniel Isaac Sendyk, Juliano Cavagni, Claudio Mendes Pannuti
Rok vydání: 2022
Popis: Objectives: This study aimed to investigate the prevalence of a type of bias named Selective Outcome Reporting (SOR) in publications of RCTs on non-surgical periodontal therapy (NSPT) and verify its associated factors. Materials and Methods: The protocols were searched and selected on the www.clinicaltrials.gov platform up to January 16, 2022. Corresponding publications were identified, and data extraction and discrepancy analysis were performed. The risk of bias was assessed according to the RoB2 tool. Results: One hundred forty-five studies (174 publications) were included. The prevalence of SOR was 49.7% and was unclear in nearly one third of studies (27.6%). Only 31.7% of the primary outcomes were completely described in the publications. The overall risk of bias was high in 60% of the included studies. SOR was associated with statistical significance (p < .001), and multiple publications of the same study (p = .005). Conclusions: Our study demonstrated the high prevalence of SOR, highlighting the need to improve the quality of reporting of RCTs on NSPT studies. Clinical relevance: SOR is a concerning bias that can affect clinical practice as it increases the effect of the intervention, emphasizing positive results. The incidence of SOR can be reduced by the prospective registry of the study protocol and the complete definition of the outcome. Journal editors could instruct reviewers to check discrepancies between the protocol and the manuscript whenever such information is available.
Databáze: OpenAIRE