Journal Article

Pitfalls of Assessing Hepatotoxicity in Trials and Observational Cohorts

Caroline A. Sabin

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 38, issue Supplement_2, pages S56-S64
Published in print March 2004 | ISSN: 1058-4838
Published online March 2004 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/381448
Pitfalls of Assessing Hepatotoxicity in Trials and Observational Cohorts

More Like This

Show all results sharing these subjects:

  • Infectious Diseases
  • Immunology
  • Public Health and Epidemiology
  • Microbiology

GO

Show Summary Details

Preview

The relationship between the use of antiretroviral drugs and the development of hepatic abnormalities has been documented in both randomized controlled trials (RCTs) and observational database studies. Both types of study design are known to have limitations when addressing this issue. Whereas RCTs may enroll a population that is at lower risk for the development of hepatotoxicity, thus underestimating the possible effect of antiretroviral therapy on hepatic abnormalities, observational databases may encompass information from a more heterogeneous group of patients, allowing the drugs to be assessed in a more realistic situation. However, a number of possible biases associated with the use of observational data may limit the conclusions that can be drawn from such studies. I describe some of the benefits and limitations of RCTs and observational data sets when drawing conclusions about the relationship between antiretroviral therapy and the development of hepatic abnormalities.

Journal Article.  5746 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

Full text: subscription required

How to subscribe Recommend to my Librarian

Users without a subscription are not able to see the full content. Please, subscribe or login to access all content.