April 2014
Volume 55, Issue 13
ARVO Annual Meeting Abstract  |   April 2014
Reporting of Harms by Randomized Controlled Trials in Ophthalmology
Author Affiliations & Notes
  • Roderick O'Day
    Royal Victorian Eye and Ear Hospital, East Melbourne, VIC, Australia
    Save Sight Institute, University of Sydney, Sydney, NSW, Australia
  • Richard Walton
    Save Sight Institute, University of Sydney, Sydney, NSW, Australia
  • Richard Blennerhassett
    Westmead Hospital, Sydney, NSW, Australia
  • Mark C Gillies
    Save Sight Institute, University of Sydney, Sydney, NSW, Australia
  • Daniel Barthelmes
    Save Sight Institute, University of Sydney, Sydney, NSW, Australia
    Ophthalmology, University Hospital Zurich, Zurich, Switzerland
  • Footnotes
    Commercial Relationships Roderick O'Day, None; Richard Walton, None; Richard Blennerhassett, None; Mark Gillies, Allergan (C), Bayer (C), Novartis (C); Daniel Barthelmes, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 5547. doi:
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      Roderick O'Day, Richard Walton, Richard Blennerhassett, Mark C Gillies, Daniel Barthelmes; Reporting of Harms by Randomized Controlled Trials in Ophthalmology. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5547.

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

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Purpose: To evaluate the reporting of harms by randomized controlled trials investigating intravitreal therapies for diabetic macular edema.

Methods: A thorough literature search identified eligible reports. Two authors independently extracted data from these using a prospectively created checklist. The main outcome measure was compliance with the 10 recommendations of the 2004 Consolidated Standards of Reporting Trials statement extension for better harms reporting. Secondary outcomes were the predictors of the number of recommendations met and the amount of space devoted to harms reporting.

Results: Thirty-six articles involving 7246 eyes met the criteria for analysis. The fidelity of the data extraction was excellent, with Cohen’s kappa coefficient of 0.90 for all items extracted. The median number of recommendations met was 6, interquartile range 5 to 7. Recommendation four (describe how harms-related information was collected) was met by 97% of articles and recommendation eight (present the absolute risk of each adverse event) by 92%. The least frequently met recommendations were numbers three (list addressed adverse events with definitions of each), 31% of articles, and six (describe participant withdrawals because of harms), 36% of articles. The following article characteristics were associated with meeting more recommendations by univariate analyses: articles reporting trials that were placebo-controlled, involved a dose comparison, had more than the median sample size, were multi-centered and were commercially funded; and articles that were published in journals with an impact factor more than 3. However, none of these article characteristics were found to be associated with the number of recommendations met using a binomial regression analysis. The mean percentage of the results section devoted to harms-related data was 25.8%, standard deviation 10.8%.

Conclusions: Harms reporting in published reports of trials of intravitreal therapies for diabetic macular edema is still not entirely adequate despite increased attention and efforts to standardise it.

Keywords: 462 clinical (human) or epidemiologic studies: outcomes/complications • 499 diabetic retinopathy  

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