Reporting of adverse events in randomized controlled trials of highly active antiretroviral therapy: systematic review

J Antimicrob Chemother. 2009 Aug;64(2):239-50. doi: 10.1093/jac/dkp191. Epub 2009 May 28.


Objectives: Our objectives were to systematically assess the quality of reporting of adverse events (AEs) in publications of randomized trials of highly active antiretroviral therapy (HAART), and to examine whether reporting quality affects the effect estimates reported for AEs.

Methods: We searched the PubMed, Cochrane library and EMBASE electronic databases up to December 2008. We included all published randomized controlled trials assessing HAART for treatment-naive adult HIV-infected individuals, with 48 weeks' follow-up. The quality of AE reporting was extracted according to CONSORT guidelines. We pooled the relative risks for AEs and compared results by sponsorship and different reporting methods.

Results: Forty-nine trials, including 19 882 patients, published between 2000 and 2008, met the inclusion criteria. Only one of the trials reported on AE collection methods. Twenty-six trials reported only AEs attributed to drugs, 17 of which did not refer to the attribution methods. AE reporting was nearly always selective and selection criteria were highly variable, based on severity grading or occurrence threshold. Presentation of AEs above an occurrence threshold was more common in studies sponsored by industry (30/31) than in studies sponsored by non-profit organizations (3/18). Moreover, we showed that differences in the methods of reporting AEs may affect the results reported for AEs. No significant improvement in AE reporting was seen over this period.

Conclusions: We found substantial variability in AE reporting. Variability was influenced by sponsor identity and affected outcomes. These facts obstruct our ability to choose HAART based on currently published data.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Antiretroviral Therapy, Highly Active / adverse effects*
  • HIV Infections / drug therapy*
  • Humans
  • Publications / statistics & numerical data*
  • Randomized Controlled Trials as Topic