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Reporting of Complications in Retinal Detachment Surgical Trials: A Systematic Review using the CONSORT Extension for Harms

  • Zheng Yang Xu
  • , Augusto Azuara-Blanco
  • , Kazuaki Kadonosono
  • , Timothy Murray
  • , Sundaram Natarajan
  • , Samantha Sii
  • , William Smiddy
  • , David H Steel
  • , Thomas J. Wolfensberger
  • , Noemi Lois

Research output: Contribution to journalArticlepeer-review

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Abstract

Question: What is the quality of reporting of harms in randomized clinical trials (RCTs) of rhegmatogenous retinal detachment (RRD) surgery?

Findings: A systematic review of RCTs in RRD surgery using the Consolidated Standards of Reporting Trials Extension for Harms checklist was conducted. The median number of checklist items reported was 8 (range, 0-15), and infrequently reported criteria included distinguishing between expected and unexpected adverse events and use of a validated instrument to report adverse event severity.

Meaning: These results suggest there are key areas that need improvement in the reporting of complications of RRD surgical trials.
Original languageEnglish
Pages (from-to)898-905
JournalJAMA Ophthalmology
Volume139
Issue number8
DOIs
Publication statusPublished - 17 Jun 2021

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