Platform Options and TradeoffsCHC Study Description

Mike Jarrett

February 7, 2006

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

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

Research Platform MatrixPaper and Excel Desktop DB Enterprise DB Application

Ease of use High Med Low Med/High

Security People Dependent Low High High

Technical skills Required

Low Med / High (depends on study requirements)

High Low/Medium

Cost None Low for do-it-yourselfers Med/High for consultants

High Med/High

Self sufficiency High Med Low Depends on Vendor

User population Researcher User only

Small Team Med/Large Team Med/Large Team

Sites involved One only One only (can be used for more with special effort)

If web – unlimited If Client/Server, depends

If web – unlimited

If Client/Server, depends

Special Data type Low volumes handled manually

Depends on type, either manual or integrated

Works well for large databases

Depends on vendor

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

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.

Specific Aims for the CHC Study

1. 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

2. To assess the relationship between characteristics of heterosexual partnerships, parental and peer influences, and contraceptive choice.

3. To evaluate factors associated with long-term (1 year) continuation of the methods. .

4. To identify attributes of new combination hormonal contraceptive methods associated with user satisfaction and long-term continuation

5. 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.

General Database Description•Data is collected through a web-based questionnaire. Women are screened and if eligible are then tracked though the initial visit, a three-month, six-month and one-year followup. •The data structures are relatively simple. The variable count for each of the ‘visit’ tables is large (400+ for Visit One, 200+ for Visits Two and Three and 400+ for Visit Four).•The data are stored in a MySQL database accessed through Qgen, an application used for managing the data and creating questionnaires.

 

 

 

 

Database Structure

Subject

Visit ThreeVisit TwoVisit OneScreening Visit Four

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

Data Collection and Entry

• Data are collected using a web-based, skip-logic oriented questionnaire

• Demonstration

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.)

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)

Subject Count: 330 Count by Site: Count by RA: Count by Method

Hayward:33 RA1: 40 Pill: 139

Oakland: 139 RA2: 74 Depo: 32

Richmond: 117 RA3: 117 Patch: 124

Vallejo: 41 RA4:99 Ring: 35

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

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