Applying the CONSORT and STROBE Statements to Evaluate the Reporting Quality of Neovascular Age-related Macular Degeneration Studies

Purpose: To evaluate the quality of reporting in the neovascular age-related macular degeneration (nvAMD) literature by applying the Consolidated Standards for Reporting Trials (CONSORT) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement writing standards. Design: CONSORT and STROBE impact analysis; literature review. Participants: Phase III randomized controlled trials (RCTs) of verteporfin photodynamic therapy, pegaptanib, and ranibizumab, and interventional case studies of bevacizumab for nvAMD. Methods: A literature search identified eligible articles published before October 31, 2007. We assessed the report quality of Phase III RCTs using the CONSORT statement and case series publications using the STROBE statement, both with indicators relevant to nvAMD. Main Outcome Measures: Presence or absence of CONSORT or STROBE statement indicators. Results: Seven publications of Phase III RCTs and 29 publications on bevacizumab interventional case studies for nvAMD met our inclusion criteria. Of 37 possible CONSORT writing guideline items, the mean report quality for RCTs was 30.6 (83%), with a range from 23 to 35 (65%-95%). Of 35 possible STROBE writing guideline items, the mean report quality grade for intravitreal bevacizumab case series was 23 (70%), with a range from 16 to 31 (46%-94%). Among the bevacizumab studies, more than 90% reported scientific background, drug dose and administration, baseline characteristics, unadjusted results, and adverse events. Fewer than 20% reported study size calculations, handling of missing data, or a discussion of bias. Conclusions: Since the adoption of the CONSORT standards by Ophthalmology and other journals in 1996, the reporting quality for RCTs has further improved among this cohort of nvAMD articles. On the other hand, no reporting standards for case series have existed until the recent publication of the STROBE statement. In this first application of the STROBE standards to ophthalmology, we found that the small interventional studies in our series had an average reporting score lower than the RCTs, but also that some individual scores were higher than the RCTs. This outcome demonstrates that good, useful articles can be written about small studies. Although not a direct measure of the quality of a study, good reporting allows a reader to assess the validity and applicability of the study's findings. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2009;116:286-296 (C) 2009 by the American Academy of Ophthalmology.