Quality of Reporting of Key Methodological Items of Randomized Controlled Trials in Clinical Ophthalmic Journals

Abstract

Purpose: To evaluate the reporting quality of key methodological items in randomized controlled trials (RCTs) in four general clinical ophthalmology journals.Methods: The reporting of 11 key methodological items in RCTs published in American Journal of Ophthalmology, Archives of Ophthalmology, British Journal of Ophthalmology and Ophthalmology in the year 2005 was assessed. Results : Sixty-seven eligible RCTs were assessed and the mean number of items reported was 6.3 per RCT. No significant difference in the mean number of items reported was found between the four journals (P = 0.20). The most frequently reported item was ethics approval and informed consent (97.0%), followed by masking status (85.1%), description of withdrawals (76.1%), adverse events (73.1%), and intention-to-treat analysis (71.6%). Details on sequence generation, randomization restriction, allocation concealment, allocation implementation, patient flow diagrams, and sample size calculation were reported in < 50% of the RCTs assessed. Both sample size and page length of the RCTs correlated with the number of methodological items reported (P = 0.024 and P = 0.008, respectively). Conclusions: Similar to other specialties, rooms for improvement exist in the reporting of key methodological items of RCTs in clinical ophthalmic journals. Stricter adoption of the CONSORT statement might enhance the reporting quality of RCTs in ophthalmic journals.

Keywords:

• Evidence-Based Medicine
• Ophthalmology
• Randomized Controlled Trials
• CONSORT Statement