Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.

ABSTRACT:

Objectives

Non-inferiority (NI) randomized clinical trials (RCTs) commonly evaluate efficacy of new antiretroviral (ARV) drugs in human immunodeficiency virus (HIV) patients. Their reporting and interpretation have not been systematically evaluated. We evaluated the reporting of NI RCTs in HIV patients according to the CONSORT statement and assessed the degree of misinterpretation of RCTs when NI was inconclusive or not established.

Design

Systematic review.

Methods

PubMed, Web of Science, and Scopus were reviewed until December 2011. Selection and extraction was performed independently by three reviewers.

Results

Of the 42 RCTs (n = 21,919; range 41-3,316) selected, 23 were in ARV-naïve and 19 in ARV-experienced patients. Twenty-seven (64%) RCTs provided infor

SUBMITTER: Hernandez AV 

PROVIDER: S-EPMC3643946 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature