Platform Options and Tradeoffs CHC Study Description

1. Platform Options and TradeoffsCHC Study Description Mike Jarrett February 7, 2006

2. Research Platform Considerations|What should I use for my study? • Ease of use • Security • Technical skills required • Cost • Self sufficiency • User population • Sites involved • Special Data type

3. Research Platform Options • Paper and Excel • Best for unstructured data or the research data model is unclear • Desktop Databases (Access, Filemaker) • Best for simpler studies, small numbers of users • Enterprise Databases (SQLServer, MySQL, Oracle) • Best for larger studies with technically savvy developers, larger budgets and specialized data type requirements • Study Management Applications (Qgen, Velos, StudyTRAX, Accelere) • Best for medium and larger studies

4. Research Platform Matrix

5. Hybrid Approaches • Terminal Server – Uses Access or other desktop applications as a simulated Enterprise database • Database replication – Copies of desktop applications that role into a master dataset

6. CHC Study A cross-sectional and cohort study to determine the association between initial choice of combination hormonal contraceptive method (the transdermal patch, vaginal ring, or OCPs) and multiple outcomes (including continuation of the initially chosen method) in “high-risk” women*. * Defined as unmarried, low-income and/or minority women, ages 15-24, who initiate one of the new user-controlled combination hormonal contraceptive methods.

7. Specific Aims for the CHC Study • To assess the relationship between individual characteristics and contraceptive choice among high-risk women seeking to avoid pregnancy who initiate reversible, user-controlled, combination hormonal contraceptive (CHC) methods • To assess the relationship between characteristics of heterosexual partnerships, parental and peer influences, and contraceptive choice. • To evaluate factors associated with long-term (1 year) continuation of the methods. . • To identify attributes of new combination hormonal contraceptive methods associated with user satisfaction and long-term continuation • To assess the extent to which high-risk young women who use these methods use condoms and are dual users of condoms and to determine characteristics of dual users.

9. Subject Screening Visit One Visit Two Visit Three Visit Four Database Structure

10. Database Structure Approach “Based on everything that I’ve learned in this class, isn’t that bad normalization?” • Each visit has a very different variable set, so there is a one-to-one relationship between Subject and Visit 1-4 tables

11. Data Collection and Entry • Data are collected using a web-based, skip-logic oriented questionnaire • Demonstration

12. Error Checking and Validation • Direct user input into the system • Answers are typically ‘select one’ or ‘select all’ from a set of responses • Each question must be answered before continuing • Users may opt to skip a response, but must do so affirmatively. (I don’t want to answer must be checked.)

13. Analysis and Reporting • Data are extracted and downloaded into xml or .csv files for loading into SPSS • There is a tickler function for follow-ups • There are several standard reports (NIH reporting, breakdown by method/RA/site, etc)

14. Security and Confidentiality • Data are entered through a web-browser that is SSL enabled • All system access is provide by a login and password • Each login and data update is logged • PHI fields can be restricted

15. Administration and Back up • Qgen runs in a secured data center • Backups are managed by the application vendor • Users are setup and removed by ‘Administrative’ level team members