Leveraging system sciences methods in clinical trial evaluation: An example concerning African American women diagnosed with breast cancer via the Patient Navigation in Medically Underserved Areas study.

BACKGROUND: Systems science methodologies offer a promising assessment approach for clinical trials by: 1) providing an in-silico laboratory to conduct investigations where purely empirical research may be infeasible or unethical; and, 2) offering a more precise measurement of intervention benefits across individual, network, and population levels. We propose to assess the potential of systems sciences methodologies by quantifying the spillover effects of randomized controlled trial via empirical social network analysis and agent-based models (ABM). DESIGN/METHODS: We will evaluate the effects of the Patient Navigation in Medically Underserved Areas (PNMUA) study on adult African American participants diagnosed with breast cancer and their networks through social network analysis and agent-based modeling. First, we will survey 100 original trial participants (50 navigated, 50 non-navigated) and 150 of members of their social networks (75 from navigated, 75 non-navigated) to assess if navigation results in: 1) greater dissemination of breast health information and breast healthcare utilization throughout the trial participants' networks; and, 2) lower incremental costs, when incorporating navigation effects on trial participants and network members. Second, we will compare cost-effectiveness models, using a provider perspective, incorporating effects on trial participants versus trial participants and network members. Third, we will develop an ABM platform, parameterized using published data sources and PNMUA data, to examine if navigation increases the proportion of early stage breast cancer diagnoses. DISCUSSION: Our study results will provide promising venues for leveraging systems science methodologies in clinical trial evaluation.