Abstract
BackgroundIntention-to-treat (ITT) analysis is commonly recommended for use, due to its benefits on external validity, in randomized, controlled trials (RCTs). No published reports describe how ITT analysis, as well as alternative approaches, are used in anti-infective RCTs. The purpose of this study is to describe the extent to which ITT analysis and alternative data approaches are used, the practices used to handle missing subject data, and whether non-inferiority trials present both ITT and per protocol (PP) analyses. Results of this analysis will help guide end users of infectious diseases primary drug literature.MethodsA cross-sectional study of RCTs of anti-infectives published from January 1, 2013 through December 31, 2014 was conducted. A PubMed search identified relevant articles published in five specialty infectious diseases journals and four general medical journals. Each article was reviewed by two independent investigators with discrepancies resolved by consensus. Descriptive statistics were used to quantify results.ResultsOne hundred four articles met study criteria. The most common medication classes represented in the RCTs were hepatitis C antivirals (26 %), antibacterials (25 %), and antiretrovirals (21 %). Thirty studies (29 %) were non-inferiority trials. Most studies (77 %) described use of ITT or modified ITT (mITT) in their methods. Of the ITT and mITT studies, most (73 %) did not describe practices used to handle missing data. Most (97 %) non-inferiority trials described use of ITT, mITT, or both; however, only 15 (50 %) also described use of PP.ConclusionsRCTs of anti-infectives commonly employ ITT and mITT. Most do not describe how missing data were addressed. Non-inferiority trials of anti-infectives do not consistently employ both ITT and PP populations.Electronic supplementary materialThe online version of this article (doi:10.1186/s12874-016-0215-2) contains supplementary material, which is available to authorized users.
Highlights
Intention-to-treat (ITT) analysis is commonly recommended for use, due to its benefits on external validity, in randomized, controlled trials (RCTs)
In order to better understand use of ITT and related methods in published RCTs of anti-infectives, and how current practice benchmarks to best practices, the objectives of this study were to: 1. Describe the extent to which ITT analysis and alternative approaches to data analysis are used
Results from this study strongly suggest that most RCTs of anti-infectives consistently employ ITT or modified ITT (mITT), which should provide the most conservative estimate of effect size
Summary
Intention-to-treat (ITT) analysis is commonly recommended for use, due to its benefits on external validity, in randomized, controlled trials (RCTs). The purpose of this study is to describe the extent to which ITT analysis and alternative data approaches are used, the practices used to handle missing subject data, and whether non-inferiority trials present both ITT and per protocol (PP) analyses Results of this analysis will help guide end users of infectious diseases primary drug literature. ITT analysis includes all patients regardless of adherence to study protocol and attrition, maximizing external validity, and more closely mirroring circumstances encountered in actual practice. This yields estimates of treatment effect that are more. A common modification is including all patients who were randomized and received at least one treatment dose
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