Abstract
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. 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. 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. 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.
Highlights
Selection of highly active antiretroviral therapy (HAART) is currently based on the relative efficacy and toxicity of the various HAART regimens
Reporting based on occurrence threshold all adverse events (AEs) reported above some threshold Detailed AEs that led to discontinuation (%)
The field of HIV therapy has undergone a major change in the last two decades, from monotherapy given to AIDS patients in the late stages of their disease, to potent triple therapy given to asymptomatic patients
Summary
Selection of highly active antiretroviral therapy (HAART) is currently based on the relative efficacy and toxicity of the various HAART regimens. With improving efficacy and patient life span, attention to adverse events (AEs) experienced with each regimen and the resulting quality of life has become a major determinant in selecting a HAART regimen for the individual patient.[1] Recommendations for treatment regimens are currently based on large randomized controlled trials (RCTs).[2] These trials serve as an important platform for assessing antiretroviral drug-related AEs. not all AEs appear during the limited follow-up period of RCTs and some rare AEs are revealed only after longer exposure of larger populations, RCTs have the advantage of intensively following up well-characterized populations. In the area of HIV, Carr[6] pointed out weaknesses in the monitoring, analysis and reporting of AEs in trials assessing antiretroviral therapy, and formulated a set of recommendations for improvement, addressing the special problems of these trials
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