Research electronic data capture (REDCap)

advertisement
. . . for our health
Research electronic data capture
(REDCap): A promising resource for
database development and
management and in PBRN research
Hannah Louks
University of Wisconsin School of Medicine and Public Health
Department of Family Medicine
Outline
•
•
•
•
•
•
•
•
What is REDCap?
Background
Why WREN uses REDCap
Overview of key features
Surveys
Tips for good design
Limitations
Resources
What is
?
• Research Electronic Data Capture
• Used for building and managing surveys and
databases quickly and securely
▪ This includes protected health information (PHI)
• 462 consortium partners and rapidly growing
• Developed at Vanderbilt University in 2004
Background: Challenges across PBRNs
▪ 116 primary care PBRNs
۰ 73% of practices have collaborated with another PBRN or plan to
▪ National studies across PBRNs (i.e. CKD
Guideline project)
▪ Continued need to share data quickly and
securely across PBRNs
۰ Especially so with new AHRQ Research Centers (P30s)
Background: Challenges within PBRNs
▪ Vast distribution of PBRN members across
states/regions
▪ Multicenter research designs
▪ Multisite research networks (i.e. WREN)
▪ Need to share data quickly and securely across
sites
Background: Data Management and Quality
• Substantial coordination and management needed to
ensure high data quality, addressing:
▪ Accessibility
▪ Accuracy
▪ Completeness
▪ Comprehensiveness
▪ Security
• Why is this important?
▪ Ensures consistency
▪ Instills confidence in stakeholders, participants, etc.
▪ Lays groundwork for uncomplicated data cleaning
and analysis
Some reasons
uses
• Regional Research Coordinators can create data
collection forms and surveys without the need for a
programmer. (Although, will need a programmer to facilitate REDCap startup and software
maintenance.)
• RRCs can access data for multicenter studies
regardless of where data collection is taking place
(i.e. in a practice, remote chart abstraction from the
office, etc.)
• All data stored on REDCap compliant with UW IRB
HIPAA standards for security.
• Audit trails for tracking data manipulation and
import/export.
• Suitable for (almost) any multi-site study with webbased data entry capabilities.
Surveys
vs. Data entry forms
-“Read-only” after submission
-Can modify data at any time, as
long as permitted
-Data entry performed by the
participant
-Report building
-URL can give access to form,
regardless if REDCap user
-Scheduling
module
-Can be built
using online
designer or
offline data
dictionary
-Audited data entry
-Data entry performed by
research team
-Authorized REDCap users only
Sample case report
form
Web-based data
collection form
builder
Data dictionary:
Offline method for
building data
collection form
Audit Trail
Field Types
• Field Types (13 types)
▪
▪
▪
▪
Text box
Notes box
Calculated field
Multiple choice
۰ Radio and dropdown buttons
۰ Must select one answer only
▪
▪
▪
▪
▪
▪
▪
Checkboxes (Multiple answers)
Yes/No
Begin new section
True/False
Slider/Visual Analog Scale
File upload
Descriptive Text
• Matrix of Fields
Field Types: Screen Shots
Text Box
Notes Box
File Upload
Field Types: Screen Shots
Calculated
Field
Radio
Buttons
Checkboxes
Dropdown
Field Types: Screen Shots
Yes/No
Section
Header
True/False
Slider/Analog
Scale
Text Box Validation Option
• Hard Validation - Error
message displayed if entry
does not match expected
format and entry not saved.
• Soft Validation - Minimum &
Maximum Values
▪
▪
Can enter (not required) for date, integer, number, and time options.
Will alert data enterer if entry is outside of range, but will still save entry.
Required and Identifier Fields
• Required – Will alert data enterer if “required” field is
left blank, but will allow you to opt to leave blank.
• Identifier – Tags variables with PHI for removal
option during export.
Matrix of Fields
• Ideal for grouping of questions that share same
response options (i.e. Likert scale questions)
• “Answer Format” can be specified as radio buttons or
checkboxes.
Screen shot courtesy of University of Iowa ICTS.
Branching Logic
• Can be applied to a field to specify whether it will be
displayed depending on information from other
fields.
• ‘Section Header’ is the only field type that does not
allow branching logic.
Quality Control
Data Access Groups
Allow multiple groups to enter
data in one database without
groups being able to view
each other’s data.
Reports, Graphs, and Descriptive Stats
REDCap can display data
using three different
graphs types: bar charts,
pie charts, and scatter
plots.
Can navigate to a specific data
record within REDCap by clicking on
the associated data marker
Data Visualization
Easily identify
potential outliers.
Data Export
REDCap Survey
Pros
•Private or public links
Cons
•May only create one survey per
project
•Responses are secure
•Ability to e-mail non-respondents
•Multiple options and features for
customizability
•Survey responses can not be
changed once submitted (by either
the respondent or the data enterer)
Survey Options
• Triggers & Notifications
▪ You or other users will be notified via e-mail every time a
respondent completes a survey
• “Save & Return Later” option
▪ Allows respondents to save a partially completed survey
and complete the remaining portion at a later time.
▪ Respondents will be given a unique validation code to enter
when they return to the survey.
۰ If the validation code is lost, the researcher can NOT
recover this for the respondent – Keep this in mind when
selecting this option.
• Allow participants to view aggregate survey responses
Example: Screening Survey
(and miscellaneous features)
Use HTML tags for
font control
Reverse scoring
Example: Screening Survey cont.
Screen shown to
respondent
Tips for Good Design
• “Don’t use a hammer to swat a fly off
someone’s head.”
▪ Just because technology is available, does not mean you
should use it.
• Group similar information into sections.
• Go through multiple trial runs with your
database before moving a project to
“production mode.”
▪ Allows for less confusion down the road.
Limitations
• Limited flexibility in form design
• Data entry on online form only possible with web or
3G connection
• Once a project is in “production mode,” any changes
must be submitted to a REDCap administrator for
approval
▪ Some revisions may not be allowed (i.e. changing
variable names)
• Not 21 CFR Part 11-compliant (not suitable for FDA
governed clinical trials)
Resources
• http://project-redcap.org
▪ REDCap Shared Library – a repository for
REDCap data collection instruments and forms
that can be downloaded and used (for free) by
consortium partners
▪ Video Resources – Webinars and tutorials
References & Acknowledgements
•
•
•
•
•
Paul Smith, Melody Bockenfeld, Mark Remiker, Kate Judge, and Don
Thomson
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG.
Research electronic data capture (REDCap) – A metadata-driven
methodology and workflow process for providing translational research
informatics support. J Biomed Inform. April 2009;42(2): 377-381.
Pace WD, Staton EW. Electronic data collection options for practicebased research networks. Ann Fam Med. 2005;3(Suppl 1): S21-S29.
Practice Based Research Networks (PBRN): PBRN Information. 14
May 2012. Available at
http://pbrn.ahrq.gov/portal/server.pt/community/practice_based_resear
ch_networks_%28pbrn%29__pbrn_information/855/pbrn_slides/28200
, Accessed 10 August 2012.
Select REDCap screenshots used with permission from University of
Chicago Initiative in Biomedical Informatics.
Download