April 2011
Volume 52, Issue 14
ARVO Annual Meeting Abstract  |   April 2011
Quality Of Reporting Of Randomised Clinical Trials In Ophthalmology
Author Affiliations & Notes
  • Reena Kumari
    Ophthalmology, Aberdeen Royal Infirmary, Aberdeen, United Kingdom
  • Neil W. Scott
    Department of Public Health,, University of Aberdeen, Aberdeen, United Kingdom
  • Noemi Lois
    Ophthalmology, Aberdeen Royal Infirmary, Aberdeen, United Kingdom
  • Footnotes
    Commercial Relationships  Reena Kumari, None; Neil W. Scott, None; Noemi Lois, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 2803. doi:
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      Reena Kumari, Neil W. Scott, Noemi Lois; Quality Of Reporting Of Randomised Clinical Trials In Ophthalmology. Invest. Ophthalmol. Vis. Sci. 2011;52(14):2803.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : To evaluate the quality of reporting following CONSORT (Consolidated Standards of reporting trials) guidelines of randomised clinical trials (RCTs) in Ophthalmology.

Methods: : Five high impact-factor journals (Ophthalmology, Investigative Ophthalmology and Visual Sciences, British Journal of Ophthalmology, American Journal of Ophthalmology and Retina) were selected for this study; all RCTs published in these journals during a period of 12 months, from January 2009-to December 2009 were included. RCT reporting was checked against the CONSORT guidelines on reporting (2001 statement) which included 22 items. Each item on the CONSORT statement was considered to be reported if the item was partially or fully covered in the manuscript. An item was considered not to be reported only when there was no mention of it.

Results: : A total of 80 manuscripts reporting on RCT’s were found during the period of the study and reviewed. Eleven of these were excluded as these manuscripts referred to further evaluation of RCTs that had been already published, leaving 69 manuscripts reporting on RCTs included. On average, less than 30% of manuscripts followed CONSORT guidelines on reporting of sample size, randomisation - allocation concealment and randomisation - implementation. There was between 30%-60% of manuscript reporting on outcomes, blinding, recruitment, outcomes and estimation, adverse events, generalizability and overall evidence. On average there was between 60%-90% manuscripts reported on statistical methods, participant flow, baseline data, ancillary analysis, However, on average over 90% of the manuscripts followed CONSORT guidelines on reporting of title and abstract, background, participants, interventions, objectives, number analyzed and interpretation of findings on the discussion.

Conclusions: : An improvement in the quality of reporting of RCTs in Ophthalmology is needed for adequate interpretation of published findings. Specifically, researchers should be aware of the need of reporting on sample size and method of randomisation used in RCT’s.

Keywords: clinical (human) or epidemiologic studies: biostatistics/epidemiology methodology 

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