Developing a Suite of
Electronic Data Capture Applications
Based on an Open-Source
Instrument Definition Standard
Leon Rozenblit, Ph.D., Founder & CEO
© 2015 Prometheus Research
Contact Info & References
Leon Rozenblit, JD, Ph.D.,
Founder & CEO
[email protected] | @leon_rozenblit
(800) 693-9057 | www.prometheusresearch.com
Documentation for today’s talk:
https://doc.rexdb.org/doc/rex.instrument/
https://doc.rexdb.org/doc/rex.forms/
Source code: https://bitbucket.org/rexdb
© 2015 Prometheus Research
Disclosures
✤
I disclose that I have a relevant financial relationship with
Prometheus Research, LLC, as company management and equity
owner.
✤
I receive support from the NIH
© 2015 Prometheus Research
Problem (acutely felt in Behavioral & Mental Health research)
✤
At this moment, multiple research groups are configuring either
identical or very similar forms for use in different EDC system;
Wasted time. Lack of consistency across projects.
✤
Shouldn’t they be able to download the form configuration from
an open library of instrument definitions and reuse them in any
common EDC application?
“Instrument” = standardized, validated form for collecting data that
purports to measure some construct (e.g., a depression scale)
© 2015 Prometheus Research
Grand(-ish) Vision
Develop an open-source, portable instrument definition standard that would
describe the content, structure, display properties, and presentation logic
for an instrument. It should:
✤
Define all instrument metadata needed for transportability of data;
✤
Anticipate transformation into formats supported by other platforms;
✤
Allow multiple presentation property profiles and be extensible to novel
presentation systems;
✤
Be human readable and editable;
✤
Be available under a standard open-source license that would encourage
the evolution of a user/developer community.
© 2015 Prometheus Research
Another “Standard”?
Source: http://xkcd.com/927/
© 2015 Prometheus Research
Does it have to be a “STANDARD”?
✤
Let’s not pretend we can get everyone to adopt a new standard.
✤
Instead, let’s build a reference implementation.
✤
Then, create open-source translators that can convert instruments
between the reference implementation and existing EDCs
(RedCap, Qualtrics, RexDB).
✤
Then, create an open source library of forms using that
implementation.
© 2015 Prometheus Research
Essential Preliminary Steps
✤
Come up with an acronym: PRISMH—Portable Research
Instrument Standard for Mental Health.
✤
Get funding.*
* Research reported in this publication was supported by the
National Institute Of Mental Health of the National Institutes of
Health under Award Number R43MH106225. The content is solely the
responsibility of the authors and does not necessarily represent
the official views of the National Institutes of Health.
© 2015 Prometheus Research
Grand(-ish) Vision (cont.)
Electronic Data Capture (EDC) Tools
REDCap
Qualtrics
Mobile
EDC
RexDB
Other
EDC
Aim 4
Aim 1
Portable Research
Instrument Standard for
Mental Health
(PRISMH)
This proposal
Converter Modules
(pluggable) Aim 2
Open Library of Instrument
Definitions
Sharing level settings
and privacy controls
Source-code repository
features: revision control
& forking
Aim 3
(hosting, API)
Open Science Framework (OSF)
© 2015 Prometheus Research
Available in OSF
Community Features
Challenges
✤
Instrument versioning
✤
Requirement that data resulting from any presentation method
for a form can be merged together into a single data exploration
source.
✤
Internationalization of instrument content.
✤
Translating presentation/display properties between different
EDC platforms (question text, hints, pagination, etc).
© 2015 Prometheus Research
Limitations of Common Formats
✤
REDCap’s commonly-used configuration format is not open source;
presentation properties assume one app.
✤
CDISC-ODM is too complex and heavy-weight for this need.
✤
CDISC and CDASH are focused on use-cases that support FDAregulated clinical trials (e.g. facilitating submission of data to the
FDA).
✤
CDISC and CDASH do not make it obvious how to include a
display characteristics layer.
© 2015 Prometheus Research
Getting Started: Practical Considerations
✤
We had previously developed two open source EDC applications,
each of which focuses on a specific user class.
✤
RexEntry is focused primarily on data entry by trained clinical or
research staff members who require rapid and accurate data
transcription.
✤
RexSurvey is focused primarily on intuitive data entry by selfreporters.
✤
The first proof of concept was to refactor these two different
systems to use a common portable instrument definition: PRISMH.
© 2015 Prometheus Research
Configuration Split: Instrument vs. Form
✤
Instrument: Data element definition (variable name, data type);
supports transportability of data, but nothing about presentation.
✤
Form: Rapid data entry parameters (keyboard shortcuts, skiplogic).
✤
Form: Question-level display information (question titles, hints,
hide/disable logic).
✤
Form: Grouping information (pagination, sections).
✤
Form: Mode-specific presentation instructions.
© 2015 Prometheus Research
YAML Example: Demo Demographic Form
Instrument
id: "urn:demo-demographics-form"
version: '1.0'
title: Demo Demographic Form
record:
- id: first_name
type: text
- id: last_name
type: text
- id: gender
type:
enumerations:
female: {}
male: {}
base: enumeration
- id: age
type:
enumerations:
age18-29: {}
age30-49: {}
age50-64: {}
age65-and-over: {}
© 2015 Prometheus Research
Form Presentation
defaultLocalization: en
instrument:
id: "urn:demo-demographics-form"
version: '1.0'
pages:
- id: page1
elements:
- type: question
options:
fieldId: first_name
text:
en: First Name - type: question
options:
fieldId: last_name
text:
en: Last Name - type: question
options:
fieldId: gender
text:
YAML is compiled
into JSON at runtime.
You can configure
instruments and
forms directly in
JSON, but it is less
human-readable than
YAML
RexEntry
© 2015 Prometheus Research
RexSurvey
Configuration (YAML)
Instrument
id: "urn:demo-demographics-form"
version: '1.0'
title: Demo Demographic Form
record:
- id: first_name
type: text
- id: last_name
type: text
- id: gender
type:
enumerations:
female: {}
male: {}
base: enumeration
© 2015 Prometheus Research
Multi-lingual Survey Form
defaultLocalization: en
instrument:
id: "urn:demo-demographics-form"
version: '1.0'
pages:
- id: page1
elements:
- type: header
options:
text:
en: General Information
es: Información General
- type: question
options:
fieldId: first_name
text:
en: What is your first name?
es: ¿Cuál es tu nombre?
- type: question
options:
fieldId: last_name
The form is
configured to display
in either English or
Spanish
Two Displays From One Rex.form Config. File
© 2015 Prometheus Research
Electronic Data Capture => RexMart
Represented in a Study Management System
Instruments:
Depression Scale A
IQ Test D
Demographic Form F
...
•
•
•
•
Instrument Versions:
Depression Scale A.2
IQ Test D.1
Demographic Form F.7
...
•
•
•
•
Instrument Drafts:
Unpublished versions of
instruments, not available for
data collection
Once published the draft
becomes available as an
Instrument Version and can be
used for data collection
•
Form Display Configuration:
One form.yaml file for
each channel that an
instrument version can
be presented in
•
measure_type
measure_type_revision
measure_type_revision_
channel
measure_type_revision_
draft
measure_type_revision_
chl_draft
Methods for presenting
the instrument:
RexSurvey
RexEntry
RexSMS
•
•
•
acquire_channel
•
Trunk
Branch
to only one
© 2015 Prometheus Research
Draft Form Display Configuration:
One form.yaml file for each channel
that an instrument draft can be
presented in (after it is published as an
instrument)
•
Cross
to one or zero
Ternary
to many
Facet
Entity Relationship Diagram - RexStudy 4.2.0
rex.study.main - acquire.yaml
RexDB Component Architecture
Form Builder
RexETL
RexSurvey
RexEntry
RexPlore
solution_application
Adv. FormConfig
RexAppBuilder
make files
instrument config.
urlmap.yaml
etl.htsq
form config.
screen_config.yaml
RexMartBuilder
deploy.yaml
deploy.yaml
etl.htsql
mart_list.yaml
applet
instrument, forms
explore_ui
widget
RexAcquire
port
expression
core, web, db
ctl
convert
urlmap
htsql
explore
deploy
Legacy
RexOps DB
Legacy'
External'DBs
Database
© 2015 Prometheus Research
Legend
RexMart
Database
DB
RexApp
RexMart
data flow
config. settings
Database
End-User App
Analyst Config.
Config File
Component
Component Group
RexDB
RexDBPlatform Architecture
RexAcquire
Legacy
Database
Legacy
Database
file
Legacy
File
RexApp
RexETL
RexAppBuilder
Extract, Transform, Load
data from
multiple sources
Customize Solution Applications
and add Applets
for custom interactions
RexFormBuilder
RexOps DB
Configure Electronic
Data Capture Forms
(basic and advanced)
RexMart
RexMartBuilder
Create Exploratory Data Marts for
Data Consumers
Transactional Read/Write System
for Operational Data
RexMart DB
RexMart
DB
Analytic
Read-Only
System
that supports ad hoc queries
by end-users
Staff
file
Entered
Forms
Self
file
Reported
Forms
RexEntry
Rapid Form Entry
for Trained Staff
RexSurvey
Collect
Self-Administered Forms
from Participants
RexReference DB
RexMart data
DB for
Read-only
UI interaction but not for
ad hoc queries
Customized App
Configured Templates and Widgets generate
custom screens for customized interactions
with transactional and analytic data
RexPlore
Explore, Share and
Export Data
What Did We Learn?
✤
Separating instrument content and form presentation/display definitions is
useful for supporting multiple versions, languages, and display delivery
methods.
✤
There is a downside to splitting instrument definition from form definition:
two files are somewhat more difficult to manage than one.
✤
Some redundancy in providing two kinds of configuration data.
✤
Will try auto-generation of a base form config file from an instrument
config file.
✤
Longer-term solution: GUI Form Builder.
© 2015 Prometheus Research
New FormBuilder (Beta)
© 2015 Prometheus Research
Future
Electronic Data Capture (EDC) Tools
REDCap
Qualtrics
Mobile
EDC
RexDB
Other
EDC
Aim 4
Aim 1
Portable Research
Instrument Standard for
Mental Health
(PRISMH)
This proposal
Converter Modules
(pluggable) Aim 2
Open Library of Instrument
Definitions
Sharing level settings
and privacy controls
Source-code repository
features: revision control
& forking
Aim 3
(hosting, API)
Open Science Framework (OSF)
© 2015 Prometheus Research
Available in OSF
Community Features
Take Home
✤
Developed an open-source portable instrument definition format.
✤
Tested it with two of our own EDC applications. It works.
✤
Now proceeding with developing translators to/from REDCap & Qualtrics.
✤
Please try it out and give us your feedback.
✤
If you want to develop translators to/from your favorite EDC app, join us!
An open-source, revision-controlled instrument-definition library, based on a portable
open standard, will save resources and will enable better data sharing and interoperability
across research programs and institutions.
© 2015 Prometheus Research
Thank You!
✤
Prometheus Team
✤
Center for Open Science
✤
My co-authors:
✤
Charles Tirrell
✤
Jason Simeone (lead architect)
✤
Frank J. Farach
© 2015 Prometheus Research
Contact Info & References
Leon Rozenblit, JD, Ph.D.,
Founder & CEO
[email protected] | @leon_rozenblit
(800) 693-9057 | www.prometheusresearch.com
Documentation for today’s talk:
https://doc.rexdb.org/doc/rex.instrument/
https://doc.rexdb.org/doc/rex.forms/
Source code: https://bitbucket.org/rexdb
© 2015 Prometheus Research