Adherence to study medication and visits: data from the BABY HUG trial.

ABSTRACT:

Background

Subject retention and adherence are essential to maintain the power and validity of the Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG). We designed a study to assess adherence with study medication administration and study visits and to evaluate socioeconomic factors (SES) that may influence these measurements of adherence. These data are important for assessing impact of adherence on BABY HUG trial outcome and defining impact of SES on adherence.

Methods

Each subject's median study medication (MedAd) and mean visit adherence (VAd) were evaluated. We examined associations of adherence with SES of participating families.

Results

MedAd data were available on 153 of the 191 subjects who started randomized study medication. MedAd was 101.7% of volume

SUBMITTER: Thornburg CD 

PROVIDER: S-EPMC2795096 | biostudies-literature | 2010 Feb

REPOSITORIES: biostudies-literature