Study Characteristics

Table of Contents

Overview

The study characteristics will drive the project setup in StudyTRAX in addition to the built-in features.

Feature Summary

• Study Design
  • Longitudinal studies are set up with intervals that represent the data collection summary
  • Cross-sectional studies are set up to capture data at one specific point in time, although may include questions about the past
• Study Type
  • Patient Registries
  • Clinical Trials
• Reports
  • Driven by data
  • Automated clinic notes
    • Boilerplate and conditional logic driven text
    • Within or across visit summaries and analysis
    • All data elements completely accessible and configurable
  • Group-level reports
    • Aggregation across subjects, within or across visits
    • Combine data across patient registries and/or studies
• Automated email reminders of data collection events
• Organize and Plan Publications, Abstracts, etc.
  • Dynamically link together data collection efforts with all associated academic output
  • Manage generation of academic output using the Workbench
    • Create and organize data sets
      • Include raw, recoded, transformed, and calculated variables within or across visits
      • Utilize integrated data cleaning / scrubbing routines
      • Seamlessly transfer data to statistical packages
    • Create reports with charts, graphs, and tables dynamically linked to study data
    • Integrated word processor for report layout design and formatting
  • File and task management
    • Coordinate tasks across staff using a centralized calendar
    • Upload and track all associated files

What to Consider

Clinical Trial

• Will the treatment arms differ between groups?
• Will the forms collected vary by group assignment or subject characteristics (e.g. prostate questions only for males)
• What are the inclusion/exclusion criteria?
• Data Collection schedule
  • Assign forms to encounters (what forms are collected at what encounters)
  • What forms are filled out by subjects?
  • Encounters can be fixed (e.g. Year 1) and non-fixed (e.g. adverse event)
  • What is the target length and range of each fixed encounter?
  • Will automated emails go out to subjects for data entry at scheduled time intervals?

Patient Registry

• Start with the desired results first and then work back to data content
• The KEY consideration is transforming data into information and delivering to three primary stakeholders
  • Patients
  • Health care staff
  • Academic community
• Subject Portal
  • What proportion of targeted cohort is able to use / access a computer?
  • What information would be helpful to patients (e.g. disease FAQs, brochures, charts, graphs, feedback on goals, prognostic chart, treatment video, educational materials, etc.)
  • How can this information be customized to a specific patient?
  • What information could a patient provide that would facilitate or improve clinical care?
• Clinic Notes and Reports
  • What data driven tasks can be automated (e.g. clinic notes, group reporting, patient summaries)
  • What components of the clinic note best fit standardization or target an important research aim?
  • What information would help staff improve care and/or facilitate workflow (e.g. trends, cut-points, goals, seminal events, risk-factors, standardized scores, event date timing)
• Output
  • What academic output is planned (e.g. manuscripts, abstracts)?
  • What would make the process of creating this output faster?
  • How should data sets be set up so as to facilitate data analysis?
  • What are the planned research productivity and quality of care administrative reports?
    

Setup Steps

 Patient Registry Setup Outline

Steps to set up a project in StudyTRAX:  Project Setup Guide