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More Than a Decade Since the Latest CONSORT Non-inferiority Trials Extension: Do Infectious Diseases Trials Do

Adam S Komorowski1,2, Carson K L Lo3, Andrew K Kapoor4

  • 1Medical Microbiology, Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|September 22, 2023
PubMed

Insights

Reporting standards for non-inferiority trials in infectious diseases are still lacking over ten years after guidelines were issued. Researchers, journals, and reviewers must improve adherence to these critical reporting items.

Area of Science:

  • Infectious Diseases
  • Clinical Trials
  • Research Methodology

Background:

  • The Consolidated Standards of Reporting Trials (CONSORT) group developed a checklist for non-inferiority randomized controlled trials over a decade ago.
  • Non-inferiority trials are crucial for evaluating new treatments when superiority is not the primary goal.
  • Adherence to reporting guidelines ensures transparency and reproducibility in scientific research.

Purpose of the Study:

  • To assess the extent to which infectious diseases literature adheres to CONSORT reporting items for non-inferiority trials.
  • To highlight the persistent underreporting of essential items in published infectious diseases studies.
  • To emphasize the need for improved reporting standards in clinical research.

Main Methods:

  • A review of infectious diseases randomized controlled trials was conducted.
  • The studies were evaluated against the established CONSORT checklist for non-inferiority trials.
  • Data on the reporting of specific checklist items were collected and analyzed.

Main Results:

  • A significant underreporting of essential CONSORT checklist items was identified in infectious diseases non-inferiority trials.
  • Despite the availability of guidelines for more than ten years, compliance remains suboptimal.
  • Key reporting elements crucial for trial interpretation are frequently omitted.

Conclusions:

  • The infectious diseases research community has not fully adopted the CONSORT reporting guidelines for non-inferiority trials.
  • Trialists, journal editors, and peer reviewers must prioritize and enforce adherence to these reporting standards.
  • Improving the quality of reporting is essential for the reliable advancement of infectious diseases research.
Keywords:
anti-infective agentsdata qualitynon-inferiority trialsrandomized controlled trials as topicresearch design

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