title: Applying the CONSORT and STROBE statements to evaluate the reporting quality of neovascular age-related macular degeneration studies.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  CONSORT and STROBE impact analysis; literature review.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  Proprietary or commercial disclosure may be found after the references.
authors.affiliation: Pacific Eye Associates, California Pacific Medical Center, San Francisco, California 94115, USA. annefungmd@yahoo.com
authors.forename: Anne E
authors.initials: AE
authors.lastname: Fung
authors.forename: Ram
authors.initials: R
authors.lastname: Palanki
authors.forename: Sophie J
authors.initials: SJ
authors.lastname: Bakri
authors.forename: Eric
authors.initials: E
authors.lastname: Depperschmidt
authors.forename: Andrea
authors.initials: A
authors.lastname: Gibson
mesh_terms: D020533:Angiogenesis Inhibitors / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D052157:Aptamers, Nucleotide / Q000627:therapeutic use; D000068258:Bevacizumab; D020256:Choroidal Neovascularization / Q000209:etiology / Q000628:therapy*; D017408:Guidelines as Topic / Q000592:standards; D006801:Humans; D008268:Macular Degeneration / Q000150:complications / Q000628:therapy*; D009885:Ophthalmology / Q000592:standards*; D010506:Periodicals as Topic / Q000592:standards*; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use; D011166:Porphyrins / Q000627:therapeutic use; D011643:Publishing / Q000592:standards*; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D000069579:Ranibizumab; D000077362:Verteporfin
chemical_list: D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D052157:Aptamers, Nucleotide; D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin; C495058:pegaptanib; D000068258:Bevacizumab; D000069579:Ranibizumab