A CONSORT analysis of randomised controlled trials for the treatment of invasive aspergillosis

Brian L Jones1, Malcolm D Richardson2, Patricia M Ingram3

  • 1Department of Clinical Microbiology, Royal Infirmary, Glasgow, United Kingdom, and University of Glasgow, Glasgow, United Kingdom.

Medical Mycology
|December 5, 2016
PubMed

Insights

Reporting quality of antifungal randomized controlled trials (RCTs) for invasive aspergillosis (IA) is inconsistent. One trial report demonstrated significantly higher quality, impacting clinical recommendations.

Area of Science:

  • Medical Mycology
  • Clinical Trials Methodology
  • Evidence-Based Medicine

Background:

  • Guidelines for invasive aspergillosis (IA) treatment rely on antifungal randomized controlled trials (RCTs).
  • The reporting quality of these crucial RCTs has not been previously assessed.
  • Inconsistent reporting quality may affect the reliability of current treatment guidelines.

Purpose of the Study:

  • To evaluate the reporting quality of antifungal RCTs used in invasive aspergillosis (IA) treatment guidelines.
  • To identify variations in reporting standards among published trials.
  • To assess the potential impact of reporting quality on clinical recommendations.

Main Methods:

  • Searched Trip, Cochrane, Medline, and Embase for relevant antifungal RCTs.
  • Assessed trial report quality using the 25-item CONSORT checklist and a 4-point rating scale.
  • Calculated mean group-scores to quantify overall and specific domain reporting quality.

Main Results:

  • Seven antifungal RCTs met the inclusion criteria.
  • Overall mean reporting quality score was 2.44 out of 4, indicating moderate quality.
  • Significant variations in reporting quality were observed across trials (P < .001), particularly in Methods and Results sections.
  • The Cornely trial report exhibited the highest overall quality (3.15) and quality in Methods (3.36) and Results (3.40).

Conclusions:

  • The reporting quality of antifungal RCTs for IA varies significantly.
  • The superior reporting quality of the Cornely trial suggests it may provide more reliable data.
  • Incorporating CONSORT-based quality assessments into IA guideline development could refine clinical recommendations.

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