1. NJ CDISC Users Group April 17, 2014
Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM
Karin LaPann, MSIS
Terek Peterson, MBA
NJ CDISC Users Group
April 17, 2014

2. Agenda What are Questionnaires and How is CDISC implementing ?
How is Questionnaire Data Collected and Converted to a Standard Form?
Creating Analysis datasets with Heterogeneous questionnaire data
Processing Tips and Tricks plus Displaying the Analysis results
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18-Sep-18

3. What are Questionnaires?
Quantify feelings such as pain and depression which are not otherwise quantifiable
Numerous questionnaires used to capture this type of data
Ad Hoc  Market Surveys
Validated  FSS, MSIS, …
Copyrighted
Public Domain
Have multiple forms of responses
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18-Sep-18

4. CDISC Standards – Questionnaires
Here is a road map or all the various activities that the CDISC team is involved in. This located on the CDISC website in the Standards and implementations folder. At the top are the foundational standards, which shows the data life cycle.
Next is the XML Data exchange, which shows tools for describing and sending the data. The define.xml is an electronic file that documents the data flow down to the field and record level.
Then we have Semantics, dictionaries, and the Controlled Terminology which is used by SDTM and also some ADaM.
Finally we have the latest area of effort which is the implementations.
One large group is doing Therapeutic area implementations, using the foundational standards and customizing.
The one we are interested today is the Questionnaires implementation. This group is mapping the most common and validated questionnaires and I will show examples of this work.
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18-Sep-18

5. CDISC Questionnaire Supplements
Here is a snapshot of the list of available questionnaires on the CDISC web site.
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6. SDTM Annotated eCRF A Clear Difference
This is a simple example of a questionnaire, the Fatigue Severity Scale. This is a standard questionnaire that is typically used in clinical trials to assess disabling fatigue, such as with patients that have Multiple Sclerosis or Parkinson’s.
It is copyrighted so the questions cannot be changed in any way.
Note the scale is from strongly disagree, to strongly agree. We will follow this questionnaire through the examples to understand the transformations.
Although each question seems meaningful, they are not individually intersesting, but need to be compiled into a score in order to compare from baseline to a later timepoint.
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18-Sep-18

7. Columbia Suicide Severity Rating Scale (C-SSRS)
Disclaimer on the CDISC document
This scale is intended to be used by individuals who have received training in its administration. The questions contained in the Columbia-Suicide Severity Rating Scale are suggested probes. Ultimately, the determination of the presence of suicidal ideation or behavior depends on the judgment of the individual administering the scale.
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18-Sep-18

8. EDC FSS Collection Screen
Here is a screen shot of the FSS in an electronic data capture system. Note the drop-down box with the answer selections.
The wording is true to the copyrighted form. The data is provided with SAS formats.
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18-Sep-18

9. Samples of Controlled Terminology
Controlled Terminology (CT) for the FSS
Each questionnaire has its own unique set of Controlled Terminology.
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18-Sep-18

10. Multiple Questionnaires in QS SDTM Standard Structure
USUBJID
QSCAT
QSSCAT
QSTESTCD
QSTEST
QSORRES
QSSTRESC
QSSTRESN
ALPHA
CGI
CGI0101
CGI01-Severity of illness
Severely ill 6
CGI0102
CGI01-Global
improvement
Much worse
CGI0103
CGI01-
Efficacy index
Unchanged or worse – None 13
C-SSRS BASELINE
INTENSITY OF IDEATION
CSS0106
CSS01-Most Severe Ideation 2
CSS0109
CSS01-Most Severe Ideation, Control
Can control thoughts with a lot of difficulty 4
SUICIDAL BEHAVIOUR
CSS0120
CSS01-Suicidal Behavior
Yes Y
CSS0121A
CSS01-Most Recent Attempt Date
UPDRS
II: Activities
of Daily
Living (for
both “on” and
“off”)
UPD111
UPDRS-Activities: Hygiene
Needs help
to shower or
bathe; or
very slow in
hygienic care
The data as you saw is collected on a variety of forms with a variety of answers. You might ask, how can all these different questionnaires reside in one standardized dataset?
Well the answer lies in the vertical structure, similar to a data mart or data warehouse design, with the fields capable of storing infinitely differing data. The fields at the top highlighted in light blue are the SDTM standard field names. Note QSORRES, it stores the original answer all spelled out. Then QSSTRESC AND QSSTRESN show the alpha-numeric and the numeric versions of QSORRES.In this way we can store multiple types of data such as displayed here.
In addition to the QS dataset, there is also a demographics dataset, much like in surveys, you need to know basic demographics, such as AGE, SEX, RACE, age groups, and anything else you find important.
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18-Sep-18

11. Conversion from SDTM QS to Analysis-Ready ADaM
Step 1. Map existing SDTM to ADaM BDS structure
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12. Conversion from SDTM QS to Analysis-Ready ADaM
Step 2. Add derived rows and derived row flags
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13. Changing questions vertical to horizontal for Computations
Some Conversion Tips
Changing questions vertical to horizontal for Computations
Summing across items
Counting missing items
Imputing missing values
In summary, I have described how we capture , process and report quetionnaire data in the Pharmaceutical industry.
This can also be used as a template for other industries.
Standards are available at
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18-Sep-18

14. Annotated ADaM Table Shell
Finally we have a table shell. In the pharmaceutical industry this is presented as part of the Statistical analysis plan. It shows a map of how the data is to be displayed for analysis purposes.
In addition the SAP gives the imputation rules and guidelines on which time periods are meaningful to comp
are.
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18-Sep-18

15. Questionnaires are Used Everywhere
Pharmaceutical industry has data standards for processing Questionnaire data.
Demographic data is in the DM domain
This gets merged with QS to create the Analysis-ready ADaM datasets - ADQS
QS, DM and ADQS mappings can be used anywhere
Marketing
Data marts
Healthcare
In summary, I have described how we capture , process and report quetionnaire data in the Pharmaceutical industry.
This can also be used as a template for other industries.
Standards are available at
A Clear Difference
18-Sep-18

16. Contact Information
Karin LaPann, MSIS Principal CDISC Standards Consultant PRA International (434) Karin
Terek Peterson, MBA Senior Director, Global Standards Strategies PRA International (215)
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18-Sep-18

17. Thank You!
End Slide (Optional)