Reporting quality of noninferiority randomized controlled trials for skin disease: a meta-epidemiological study. Journal Articles uri icon

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abstract

  • Noninferiority randomized controlled trials (NI-RCTs) aim to demonstrate that an intervention has acceptable efficacy compared to an established treatment. We assessed the reporting quality of NI-RCTs evaluating treatments for skin conditions. We searched MEDLINE and Embase from inception to April 2024 for NI-RCTs published in top journals measured by h5-index. Screening, full-text review, and data-extraction were conducted independently in duplicate. We measured items reported from the Consolidated Standards of Reporting Trials (CONSORT) extension for NI-RCTs published after 2006. We included 71 NI-RCTs reporting, on average, 78% of overall and 67% of NI-RCT specific items. Forty-seven (51.6%) studies reported the noninferiority hypothesis. Sixty-five (91.5%) studies reported a noninferiority margin, with 26 (36.6%) providing justification; 48 (67.6%) calculated sample size using the margin. Twenty-two (31.0%) studies conducted both intention-to-treat (ITT) and per-protocol (PP) analyses, while 26 (36.6%) used ITT and 11 (15.5%) used PP alone. For 17 studies (24.0%), reviewers reached different conclusions from authors (7%) or could not assess appropriateness of authors' conclusions due to insufficient reporting (17.0%). Reporting of NI-RCTs for skin conditions is inconsistent, with crucial information missing from many publications. Improved reporting is essential to incorporating their results into clinical practice.

authors

  • Kim, Kevin
  • Tao, Brendan
  • Kaur, Hargun
  • Mikhail, David
  • Leung, Gareth
  • Bednar, Dimitra
  • Morassut, Rita
  • Leung, Darren
  • Miroshnychenko, Anna
  • Lynn, Matthew
  • Drucker, Aaron M
  • Chan, An-Wen

publication date

  • July 1, 2025