Risk of bias analysis in diabetic retinopathy randomized clinical trials evaluated by RoB-1 tool from Cochrane systematic reviews

• Published in: Journal of Evidence-Based Healthcare Vol. 4; p. e3791
• Main Authors: Mozetic, Vânia, Barros, Valéria, Denadai, Lucas, Bueno de Moraes, Nilva Simeren
• Format: Journal Article
• Language: English
• Published: Escola Bahiana de Medicina e Saúde Pública 20-04-2022
• Subjects: Diabetic macular edema; Diabetic Retinopathy; Randomized Controlled Trials as Topic; Risk of Bias
• ISSN: 2675-021X; 2675-021X
• DOI: 10.17267/2675-021Xevidence.2022.e3791

The objective of clinical trials is to answer about intervention in the real-world, for which they must be properly designed and executed by presenting the results reliably with the findings and in a clear way. OBJECTIVES: To identify the risk of bias in clinical trials about interventions for diabetic retinopathy and/or diabetic macular edema from Cochrane systematic reviews. METHODS: A sensitive search strategy was designed to search Cochrane systematic reviews of interventions in diabetic retinopathy and diabetic macular edema. The assessment of the risk of bias was captured as presented by the author. FINDINGS: We found eight SR and one meta-analysis network totaling 116 randomized clinical trials. Our sample revealed that among the domains randomization, allocation secret, masking of participants and personnel, incomplete outcomes, selective outcomes and others, the risk of bias assessed as low ranged from 30.4 to 49.1%; unclear risk between 22 to 56% and high risk from 1 to 21.7%. CONCLUSIONS: The risk of bias in diabetic retinopathy randomized clinical trials exists in high frequency and the reader must be aware of it.