research electronic data capture - partners healthcare€¦ · o mobile device, smart-phone ......
TRANSCRIPT
Research Electronic Data Capture
Data Management and Survey Tool
http://catalyst.harvard.edu
Lynn Simpson, MPH
Research Analytics & Data Service Manager
Partners HealthCare | Enterprise Research Infrastructure & Systems
Harvard Catalyst | The Harvard Clinical and Translational Science
Center
1
FREE license from Vanderbilt U. Medical Center
REDCap Consortium = 2051 Institutions, 107 Countries
2
http://project-redcap.org/
Overview
3
Free,
Licensed from Vanderbilt U. Medical Center
Secure,
Hosted by PHS IS Research Computing
o No purchasing, downloading software, or storing data locally
Web-based application o PC and Mac compatible
o Mobile device, Smart-phone friendly
o Accessible via internet (no VPN, remote access required)
o Compatible with all popular web browsers
Safari, Internet Explorer, Chrome, Firefox…
Fully customizable - You are in total control of shaping your database or survey. Define:
Question / Field types Validation for text fields (dates, numbers, ranges) Calculations Branching logic: hide/display fields based on data entered Piping: display data entered across forms / visits
No limit to number of data fields or forms you can program
Mid-study modifications - Modify projects as needed
during the course of your study.
4
Overview
Support Model
1.5 FTE : 8,876 Projects : 10,450 Active Users 1-2 Business Days for most responses
2-5 Business Days for some requests
Self Service Module: • Help & FAQ
• Getting Started website: http://rc.partners.org/redcapgettingstarted
• Knowledgebase: Guidelines, How-To Articles, Feature Highlights.
Test site: http://redcap-training.dipr.partners.org/redcap/
This is open access to internal Partners users - do not enter real research or clinical study data.
5
Online Form Editor
6
Q: How much experience with programming, networking and/or database construction is required to use and design EDC tools in REDCap?
A: No programming, networking or database experience required.
Use Point-and-Click interface to design your EDC tool(s).
Database Design: Data Dictionary
7
Or use “Off-line” Excel .csv File to build forms
Project Home > Other Functionality
8
Benefits: Shared Library
9
REDCap Library: Accepting requests for open domain assessments REDLOC: - Builds Forms - Obtains Licensing Requirements
Project Settings
10
There are two data collection instrument types:
1. Data Entry Forms: Data entry by study team
2. Survey: Data entry performed by subjects, participants
Data Collection
11
(1) Data Entry by Project User
REDCap Account
Required
https://redcap.partners.org/redcap
Survey
12
(2) Data Entry by participants subjects SURVEY No log in required. REDCap generates unique URLs
https://redcap.partners.org/redcap/surveys/?s=GrQES4YYR8
Project Settings
13
There are two data collection instrument types:
1. Data Entry Forms: Data entry by study team
2. Survey: Data entry performed by subjects, participants
There are two data collection formats:
1. Classic: One record per patient (WIDE)
2. Longitudinal: One record per patient per event, with
the possibility of defining multiple arms (LONG)
Wide vs Long Design
15
•Each FORM will create fields in database - Data model by REDCap is EAV – Single Table
•Projects with multiple visits executed two ways
(1) Traditional Format: (WIDE) - Create unique forms for each Visit - Data saved as one row with distinct fields
Traditional Design
16
Wide (multivariate) Example Each record is a row in data export Each Lab Visit variable is unique:
alb_b, alb_v1, alb_v2, alb_v3…
Limitations: To search for all Albumin > 10,
must parse through all alb_ variables
List of forms may get unruly if you have a lot of forms / visits; Useful for trials with less time points
Wide vs Long Design
17
(2) Longitudinal Format (LONG) - Create 1 Form for each measure - Create Events for each visit - Designate FORM to multiple EVENTS - Data saved as multiple rows with same field
• As # of EVENTS increase this option easier to execute
Longitudinal Design
18
Raw Data Representation
A new record is created for each event ALL data collected for a single event appears in one record
Un-utilized Events do not generate records
Green dot denotes that data has been entered for event
Data Management
Applications
20
Calendar - View and edit project calendar for scheduling and event tracking
Data Exports, Reports, and Stats - Extract data fields from database to Microsoft Excel, SPSS, SAS, R, STATA software (Ability to de-identified data sets), View Plots (graphical representations) and Descriptive Statistics for data entry forms; view, edit, copy, delete custom reports; query database in real time and display data in a table format.
Data Import Tool - Add and edit data by importing data into database from a Microsoft Excel file
Data Comparison Tool - Compare database records entered by designated data entry persons (double data entry)
Logging - View and export a list of all changes made to the database, including data exports, data changes, and the creation or deletion of users
File Repository - View, upload, and download project files; view and download previous data exports (data and syntax stored files)
Data Access Groups (DAGs) - Restrict access to database records by group, users in the same Data Access Group can access records created by that group. Record Locking / Locking Mgmt – Lock records to disable changes API – Allows external applications to connect to REDCap remotely; automate imports and exports REDCap Mobile App – Collect data offline (no internet access) to sync back to project
User Rights
21
Customize Each User: Application Rights Data Entry Rights
Export
22
REDCap Data Export
• Export to Excel, SPSS, SAS, STATA, R
• Numerous de-identification options
- Removal of fields that contain PHI - Automatic removal of date fields; date shifting
• Exports include corresponding syntax files
• Maintain record of entire export history
Surveys
26
- Public URL vs Participant List vs Designate an Email Address
- Anonymous
- Multiple Surveys linked to specific Participant
- Automated Survey Invitations
Survey Settings
27
- Survey Title
- Survey Instructions
- Logo
- Size of survey text
- Font of survey text
- Survey (color) theme
- Question Numbering
- Question Display Format
- Require Field options
- Survey Expiration Date
- Save & Return option
- End of Survey Options: • Auto-Continue to next
survey
• Redirect to a URL
• Survey completion text
Survey Settings
28
Longitudinal Example
Advantages
- Can designated certain instruments at certain events
- Can track which surveys have been completed
Limitations
- “Save&Return” option may not be as intuitive to manage because each
survey has it’s own link; Participant only receives 1st survey link.
Public URL vs Participant List
vs Designated Email
29
Public Survey URL: • Single survey link for your project which all participants
• Link can be copy and pasted into:
• The body of an email message in your own email client
• Posted to web pages.
• Limitations: allows for the possibility of participants taking the survey
multiple times.
• Advantages: Participants can forward or resend the link to other
participants.
Participant List: • Send emails and track who responds to your survey
• Identify an individual's survey answers by providing an Identifier for
each participant.
• Limitations: Must know email addresses
• Advantages: Tracks Responders / Non-Responders
Public URL vs Participant List
vs Designated Email
30
Designate an email field : • Example field designated: email ("E-mail address"):
• Capture email addresses for sending survey invitations on a form/
survey
• Any records with entered email address will have that email address
show in the Participant List
• Limitations: Email address saved to record
• Advantages: First instrument does not have to be a survey
Anonymous Surveys
31
Truly Anonymous = Public Survey Link
“Honest Broker” = Coded Participant List
• “Behind the scenes” link
• Information is provided to investigators in such a manner that it would not
be reasonably possible for the investigator or others to identify the
corresponding patients-subjects directly or indirectly.
• REDCap/REDCap Admins have access to the key to the code.
Public Survey Link or the Participant List
• For either method, the survey questionnaire must not contain any
questions asking the participants for identifying data
• What is your email? name? address?
Participant Contact List
• Do not enter unique values into the "Participant Identifier” field
• Links the email address to the survey responses.
Automated Survey Invitations
32
Getting Started
33
Partners HealthCare Access: https://redcap.partners.org/redcap/ Partners users can log in with their Partners usernames and passwords External users: contact EDC Support [email protected]
Language for grant and IRB submission:
http://rc.partners.org/boilerplates Getting Started website:
http://rc.partners.org/redcapgettingstarted
Training:
There is no formal training required to use REDCap. Video tutorials and Help&FAQ page in REDCap contain a lot of useful information. Test site: http://redcap-training.dipr.partners.org/redcap/ This is open access to internal Partners users - do not enter real research or
clinical study data.
Contacts
Contact Information for Harvard Catalyst REDCap Support Staff
Lynn Simpson, MPH
Jeremy Alphonse
MGH, BWH, Spaulding & McLean
http://rc.partners.org/edcredcap
BIDMC, Children’s & Joslin
http://www.bidmc.org/Research/CoreFacilities/REDCapEDC.aspx
For support for other Harvard schools or affiliated academic health care centers,
contact [email protected]
34