title: Analyzing adherence to prenatal supplement: does pill count measure up?
abstract: Objective. To determine if adherence as measured by pill count would show a significant association with serum-based measures of adherence. Methods. Data were obtained from a prenatal vitamin D supplementation trial where subjects were stratified by race and randomized into three dosing groups: 400 (control), 2000, or 4000 IU vitamin D(3)/day. One measurement of adherence was obtained via pill counts remaining compared to a novel definition for adherence using serum 25-hydroxy-vitamin D (25-OH-D) levels (absolute change in 25(OH)D over the study period and the subject's steady-state variation in their 25(OH)D levels). A multivariate logistic regression model examined whether mean percent adherence by pill count was significantly associated with the adherence measure by serum metabolite levels. Results. Subjects' mean percentage of adherence by pill count was not a significant predictor of adherence by serum metabolite levels. This finding was robust across a series of sensitivity analyses. Conclusions. Based on our novel definition of adherence, pill count was not a reliable predictor of adherence to protocol, and calls into question how adherence is measured in clinical research. Our findings have implications regarding the determination of efficacy of medications under study and offer an alternative approach to measuring adherence of long half-life supplements/medications.
authors.affiliation: Department of Pediatrics, Duke University, Durham, NC 27710, USA.
authors.forename: Kristie E
authors.initials: KE
authors.lastname: Appelgren
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Nietert
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Hulsey
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Hollis
authors.forename: Carol L
authors.initials: CL
authors.lastname: Wagner