Date of Award

January 2012

Document Type

Open Access Thesis

Degree Name

Master of Public Health (MPH)

Department

School of Public Health

First Advisor

Haiqun Lin

Second Advisor

James Dziura

Abstract

The purpose of the study was to identify differential trajectories of patient compliance in a clinical trial and to determine demographic and health risk factors associated with compliance trajectory membership. The data was obtained from an 18 month, double-blinded, placebo-controlled trial looking at the long-term impact of increased dietary protein on bone mass in older men and women. Two hundred and eight subjects were randomized to either a protein treatment or carbohydrate placebo group. Statistical analysis utilized a group-based trajectory modeling framework to identify distinct clusters of individuals who follow similar compliance trajectories over time. Post hoc analysis using multinomial and standard logistic regression models were conducted to incorporate risks factors associated with compliance group membership. A four-group trajectory model was selected and determined that reported adverse event was a significant risk factor. This analysis will provide supplementation to the standard intention-to-treat analysis to understand how efficacy is driven by compliance and will pave the way to improve compliance in subsequent protein-supplemented trials.

Comments

This is an Open Access Thesis.

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