Socioecomonic Determinants of Epilepsy

The Centers for Disease Control and Prevention intend to issues a sole source contract or purchase order to the Medical University of South Carolina to perform an analysis of data collected for the South Carolina Health Outcome Project on Epilepsy and prepare reports for publication. The statutory authority permitting other-than-full-and-open competition is 41 U.S.C., 253(c)(1): FAR 6.302-1. Only one responsible source and no other services will satisfy agency requirements. Interested persons may identify their interest and capability to respond to the requirement. This notice is not a request for competitive proposals. A determination by the Government not to compete this proposed contact will be based on responses to this notice and is solely within the discretion of the Government. Information received will be considered solely for informational purposes. This procurement is not set-aside for small business. The purpose of this request is to perform an in-depth multivariate analysis of data from the South Carolina Health Outcome Project on Epilepsy in order to elucidate role of comorbidities as determinants of epilepsy outcomes. b. The vendor will provide one or more reports of the analysis, including descriptive tables and figures ready for manuscript submission. This multivariate analysis will address determinants of epilepsy outcomes: (i) principal determinants-conditions that are comorbid at the time of epilepsy onset (neurologic, neuropsychologic, and general medical conditions); and (ii) associated determinants-epilepsy type and severity. The analysis will assess the relationships of these determinants with epilepsy outcomes such as seizure severity and frequency, secondary conditions, disability, and quality of life. Additional modifying variables (e.g., socioeconomic status (SES) and access to and utilization of medical care) will be considered. Data analysis will include the use of generalized linear mixed models (GLMM) to quantify the risk ratios the comorbidities of interest adjusting for other covariates in the model. Findings will be appropriately compared among demographic categories such as age, sex, and race. 2. Projects, Programs or Activities Supported Epilepsy Program, Arthritis, Epilepsy and Quality of Life Branch; Division of Adult and Community Health; National Center for Chronic Disease Prevention and Health Promotion; Centers for Disease Control and Prevention. 3. Objectives Served The CDC Epilepsy Program conducts and supports numerous activities focused on the early recognition, diagnosis, and treatment of epilepsy; epidemiology and surveillance of epilepsy; and assessments of quality of life to improve the public health science and to improve health outcomes among the more than 2 million U.S. adults affected by epilepsy. Identifying comorbidities of epilepsy and their distribution in diverse populations, improving access and quality of care, and improving outcomes in people with epilepsy were identified as a priority areas at the 2003 Second National Conference on Public Health and Epilepsy. Comorbid neurologic, neuropsychologic, and general medical conditions that occur with epilepsy strongly influence the severity and frequency of seizures and other outcomes such as disability and quality of life. While many studies have been able to identify the types of comorbidities that are associated with epilepsy, the extent to which these comorbidities determine the outcome of epilepsy is unclear. The SC Health outcome Project on Epilepsy has access to clinical data on a cohort of epilepsy patients that can be used to assess the outcome of epilepsy as a function of pre-existing comorbdity. The plan to assess this relationship relies on compiled clinical data from epilepsy verification forms that are completed by the physicians, linked with healthcare encounter data and data compiled from participant interviews. The data collected by the South Carolina Health Outcome Project on Epilepsy constitute a unique population-based dataset by virtue of: (1) representing a state with large minority population (largely African American), and (2) providing a wealth of detailed information collected regarding epilepsy comorbidities, severity, and outcome as well as related modifying variables and risk factors. Thus, it affords an exceptional opportunity to understand-and identify effective public health interventions for-modifiable causes of adverse outcomes among people with epilepsy. Products will include a multivariate analysis focused on the role of epilepsy comorbidities in predicting outcomes of interest (including seizure severity, disability, and quality of life), taking account of basic demographic categories, type and severity of epilepsy, SES, and healthcare access and utilization. 4. Client Identification These data will enable the Epilepsy Program of the Arthritis, Epilepsy, and Quality of Life Branch to provide, for the first time, detailed population-based descriptions of epilepsy outcomes and their principal determinants, including in racial and ethnic minorities. These descriptions will enable policy makers to develop effective primary and secondary public health prevention strategies on behalf of people with epilepsy. This project will be exempt from review by the CDC IRB because CDC staff will have no interaction with study subjects or with identifiable data and CDC scientists will be limited to a consultant role. Summary Schedule of Deliverable and Milestones or Tasks a.) Work Order Deliverables The work described will begin on August 1, 2008 and will end on July 31, 2009. September 1, 2008 -The vendor will confirm project start date and end-date. The vendor will confirm the analytic plans, including statistical modeling strategies such as generalized linear mixed models (GLMM). November 1, 2008 - The vendor will provide to CDC appropriate preliminary analyses of the frequency of principal determinants (by category of comorbidity), associated determinants (epilepsy and seizure type and initial seizure frequency), and other modifying risk factors (access and utilization of health care, SES, etc.), as well as outcome indicators, stratified by standard broad demographic categories. The vendor will also report on any problems identified with data quality and will include plans to proceed with the multivariate analysis. January 3, 2009 - The vendor will provide a preliminary report with descriptive tables and figures describing the multivariate analysis efforts to-date, including identifying any problems or difficulties encountered. July 31, 2009 - The vendor will have prepared detailed scientific manuscript(s) report that describes the project, its methods, its findings, and includes interpretation(s) and recommendation(s). The vendor will submit these to CDC in format suitable for subsequent submission to peer-reviewed scientific journal(s). The vendor will be available for individual consultation via telephone or e-mail as needed. b.) Work Order Milestones or Tasks-Payment Schedule 1. Provide individual consultation via telephone or e-mail as needed. Estimate due date: done as needed through project completion date. 2. Provide an e-mailed report of activities initiated, in process, and completed for the tasks noted in the Statement of Work and the Work Order Deliverables. Reports will be due by end of the months of October 2008, January 2009, April 2009 and July 2009. 3. Prepare and send final report(s) with content and format suitable for publication in a scientific peer-reviewed journal. a.) Special Knowledge Skills and Abilities Required of Contractor: Familiarity with dataset of the South Carolina Health Outcome Project in Epilepsy. Experience in conducting and analyzing epidemiologic studies of epilepsy. Expertise in epidemiology, biostatistics, and computer data set management and use of statistical analysis software such as SAS or equivalent products. Ability to work collaboratively with staff in the CDC Epilepsy Program.