WHAT IS ASKED IN CLINICAL DATA
REQUEST FORMS? A MULTI-SITE
THEMATIC ANALYSIS OF FORMS
TOWARDS BETTER DATA ACCESS
SUPPORT
1
DAVID A HANAUER, MD, GREGORY W. HRUBY, MA,
DANIEL G. FORT, MPH, LUKE V. RASMUSSEN,
ENEIDA A. MENDONÇA, MD, PHD, AND CHUNHUA WENG,, PHD
11/17/2014
AMIA – S43: Capturing and Organizing Phenotypes
Introduction
2
“Big ‘EHR’ Data” provides CER, PCOR, and
translational research opportunities
EHR data access to medical researchers is a key
priority
Introduction
3
EHR Data
Query Tools:
i2b2
SHRINE
RedX
STRIDE
RedCap
CAISIS
Introduction
4
Data Request Form
EHR Data
Warehouse
Researchers
Query Analyst
Data need negotiation
Introduction
5
Researchers
Query
Analyst
Regulatory
Officers
Data Request Forms
Data Owners
Motivation
6
The manner in which data request forms collect pertinent
information may have severe downstream consequences
effecting all stakeholders adversely.
Goal
7
To understand variance among EHR data request
forms for initiating communication with the key
stakeholders
Research Questions
8
1.  What are the high-level organizational categories for form
elements?
2.  What percentage of form elements are present in other
source systems?
3.  What is the distribution of form elements?
4.  How much detail does each element on a form seek?
Methods
9
10 CTSA-supported institution’s data request
forms
Development of thematic codebook including 22
codes for form annotation
Thematic codebook
10
! 
22 coding elements were distributed among
five parent categories:
!  Requester
metadata, Request metadata,
Compliance, Data use, and Miscellaneous
! 
Additionally, a comprehensive measure of
simple or extensive was used to assess each
element
Methods
11
Form annotation
! 
! 
Two reviewers independently annotated the 10
forms
Element disagreements were discussed and
consensus reached
Analysis
12
Form completeness
Sum of individual form elements
Total number of codebook form elements
Thematic representation
Number of forms with a particular coded element
Total number of forms
Results – Form completeness
13
Total Score
Percent coverage
Max
Score
A
B
C
D
E
F
G
H
I
J
46
24
5
22
8
13
16
13
10
14
22
100%
Form
52% 11% 48% 17% 28% 35% 28% 22% 30% 48%
Results – Thematic representation
14
J
# Forms
with
element
E
5
E
7
E
4
Form
Code
Description
A
1.0
Requester Metadata
1.1
Name
E
1.2
PI, supervisor, department head
E
1.3
Billing/Administrative content
1.4
Other
B
C
D
E
F
E
S
E
E
E
S
G
H
E
E
E
S
I
E
S
S
S
E = Extensive ; S = Simple
!
Element
!
“Principal Investigator: Degree(s):”
3
Results – Thematic representation
15
Form
Code
Description
A
B
C
S
S
D
E
F
G
H
I
J
# Forms
with
element
S
S
S
S
S
S
9
2.0
Request Metadata
2.1
Study Title/Request
S
2.2
Existing/New request
S
2.3
Funding source
2.4
Request purpose
2.5
Request type
2.6
Data sources
E
S
2.7
Data element specification
E
E
2.8
Recurring requests
S
S
E
S
S
S
S
S
S
E
S
E
S
3
S
S
S
4
S
S
8
S
3
S
S
S
3
S
S
6
2
!
Element
“What question(s) are you trying to answer”
“What problem(s) are you trying to solve”
!
Results – Thematic representation
16
Form
Code
Description
A
B
C
D
E
3.0
Compliance
3.1
IRB
S
3.2
IRB proof
S
3.3
PHI
E
E
3.4
Other
S
E
F
S
G
H
I
J
# Forms
with
element
S
S
4
S
2
2
E
E
4
E = Extensive ; S = Simple
!
Element
“Indicate all identifiers (PHI) that may be included in the study
research records”
“IRB Protocol #”
!
Results – Thematic representation
17
Form
Code
Description
A
B
C
4.0
Data Use
4.1
Internal data sharing
E
4.2
External collaborators DUA
E
4.3
Public sharing of original
dataset
4.4
Terms and conditions of use
4.5
Other
D
E
F
G
H
S
E
S
I
J
# Forms
with
element
4
S
E
2
1
S
S
S
2
1
!
Element
“Please specify what type of Biomedical Informatics Services
you are requesting: REDCap, Velos…”
!
Results – Thematic representation
18
Form
Code
Description
5.0
Miscellaneous
5.1
Elements not classified
elsewhere
A
S
B
C
D
E
F
E
S
S
E
G
!
Element
“Will you be contacting patients?
____No ____Yes.
If yes, please justify the need.”
!
H
I
J
# Forms
with
element
S
E
E
8
Discussion – Stakeholder Relevance
19
How do the forms help the stakeholders communicate?
! 
Data Owners and Regulatory Officers
! 
! 
! 
Query Analysts
! 
! 
Detailed documentation establishing regulatory compliance
Elements may effect request prioritization
Lessen the burdened of eliciting non-vague details from researchers
Researchers
! 
! 
Minimize bureaucratic red tape
Elements provide guidance for specifying the information need
Discussion – Researcher Communication
20
! 
Expand the scope of elements related to the data request
P
Population/Patient
I
Intervention/Indicator
C
Comparator/Control
O
Outcome
The medical researcher’s ability to formally represent the
information need prior to engaging with the data analyst
can be aided through the PICO framework
Snowball (1997) Using the clinical questions to reach search strategy: fostering transferable conceptual
skills in user education by active learning.
Conclusions
21
Form elements were highly variable in breadth
and depth
Most forms
! 
Included an abundance of Requester Metadata and
Miscellaneous elements
! 
Lacked Compliance and Data Use elements
! 
Contained simple Request Metadata elements
Future Work
22
! 
! 
! 
Why is there huge variation from comparable
institutions?
Would it be wise to reduce variation and
standardize the process?
From the perspective of key stakeholders, how are
form elements prioritized?
Acknowledgments
23
! 
This work was supported by
!  National
Library of Medicine grants R01LM009886
and R01LM010815, and by
!  National Center for Advancing Translational Sciences
grant UL1TR000040.
! 
The content is solely the responsibility of the authors
and does not necessarily represent the official views
of the supporting agencies.
Thank you!
24
Feedback appreciated:
http://is.gd/BNYKX7