CDISC SDTM TDI Questionnaire Supplement (Version 1.

0)

Transition Dyspnea Index

(TDI)
Questionnaire Supplement to the Study Data
Tabulation Model Implementation Guide
for Human Clinical Trials
Prepared by
CDISC Questionnaire Sub-team

Notes to Readers

This supplement is intended to be used with other CDISC User Guides for specific
Therapeutic/Disease Areas and follows the CDISC Study Data Tabulation Model
Implementation Guide for Human Clinical trials.

Revision History

Date Version Summary of Changes

2013-10-06 1.0 Transition Dyspnea Index (TDI) Draft
2013-10-09 1.0 Transition Dyspnea Index (TDI)

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October 09, 2013
 CDISC SDTM TDI Questionnaire Supplement (Version 1.0)

1 Introduction
This document describes the CDISC implementation of the Transition Dyspnea Index (TDI), a
standard index that is typically used in clinical trials to denote dyspnea changes since baseline, as
assessed in the Baseline Dyspnea Index (BDI).

The TDI questionnaire preceded the CDISC CDASH CRF standards and, based on its copyright
status, cannot be modified to CDASH standards.

The representation of data collected for this questionnaire is based on the Study Data Tabulation
Model Implementation Guide (SDTMIG) QS domain model, which can be found at the CDISC
website at: (http://www.cdisc.org/sdtm).

These specific implementation details for this questionnaire are meant to be used in conjunction
with the SDTMIG. All questionnaire documentation can be found on the CDISC web site at:
(http://www.cdisc.org/content2909).

The CDISC Intellectual Property Policy can be found on the CDISC web site at:
(http://www.cdisc.org/bylaws-and-policies).

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the Study Data Tabulation Model Implementation Guide for
Human Clinical Trials and is covered under Appendix F of that document, which describes
representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of
the SDTMIG for a complete version of this material.

2 Copyright Status
CDISC has obtained permission to include the TDI as part of CDISC data standards. Hence, CDISC
developed QSTESTCD and QSTEST for each question based on the actual question text on the
questionnaire. The instrument itself was not changed.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2)
standard database structure with examples, and (3) case report forms annotated with the CDISC
SDTMIG submission values.

Note: CDISC controlled terminology is maintained by NCI EVS. The most recent version should
be accessed through the CDISC website. (http://www.cdisc.org/terminology)

CDISC has developed this documentation at no cost to copyright holder or any additional cost to
users of the instrument beyond the normal licenses fees charged by the copyright holder.

CDISC acknowledges Mahler DA, Weinberg DH, Wells CK, Feinstein AR (The measurement of
dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes.
Chest 1984, 85: 751-758) for the agreement to include the TDI index in the CDISC data standards.

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 CDISC SDTM TDI Questionnaire Supplement (Version 1.0)

3 The QS Domain Model

3.1 Assumptions for Questionnaire Domain Model
All assumptions and business rules described in the SDTMIG QS domain are applicable
to this supplement. Additional assumptions specific to the Transition Dyspnea Index are
listed below.
Transition Dyspnea Index (TDI): TDI is a multiple choice questionnaire that clinicians
may use to denote dyspnea changes since baseline. The scores depend on ratings for
three different categories: change in functional impairment, change in magnitude of task,
and change in magnitude of effort. The index consists of 3 items, one for each category,
each rated in 7 grades from -3 (major deterioration) to +3 (major improvement). The
ratings for each of the three categories are added to form a transition focal score with a
range from -9 to 9. There is also a choice for impairment for reasons other than shortness
of breath.
1. The scale grades include a rating (e.g. Major Deterioration) and a definition of what
is represented by the rating (e.g. Has deteriorated two grades or greater from
baseline status.). For TDI, QSORRES is populated with the rating only. The rating
definition is considered as just a reference for the evaluator to use in assigning a
rating and is not submitted in SDTM.
2. The questionnaire evaluator should be stored in QSEVAL. For TDI, the evaluator is
usually defined as INVESTIGATOR. Additional identifying information to further
distinguish the rater in QSEVAL should be stored in QSEVALID. An example is rater
initials.
3. Terminology:
a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology.
b. A full list of value sets for qualifier, timing, result and unit fields is provided in
Section 4: SDTM Mapping Strategy.

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 CDISC SDTM TDI Questionnaire Supplement (Version 1.0)

3.2 Example for Transition Dyspnea Index (TDI) QS Domain Model

The TDI example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for two
subjects collected at one visit for a TDI questionnaire. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT.
All original results are represented with preferred terminology in QSORRES. This result is then transformed into a standard score in QSSTRESC
and a numeric representation of the standard score in QSSTRESN (if possible). The QSBLFL variable was not included in the example as all values
would have been null.

Rows 1-6: Represent the questions from the TDI form.

Row 2 shows a case where impairment was not caused by shortness of breath and QSORRES=Further Impairment for Reasons Other than
Shortness of Breath. The index standardizes this value to Z which is used as the value for QSSTRESC, and since that is not a numeric value,
QSSTRESN is null.

QS.XPT
ROW STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN
TDI01-Change in
1 STUDYX QS P0001 1 TDI0101 Functional TDI Moderate Deterioration -2 -2
Impairment
Further Impairment for
TDI01-Change in
2 STUDYX QS P0001 2 TDI0102 TDI Reasons Other than Z
Magnitude of Task
Shortness of Breath
TDI01-Change in
3 STUDYX QS P0001 3 TDI0103 TDI No Change 0 0
Magnitude of Effort
TDI01-Change in
4 STUDYX QS P0002 1 TDI0101 Functional TDI Major Improvement 3 3
Impairment
TDI01-Change in Moderate
5 STUDYX QS P0002 2 TDI0102 TDI 2 2
Magnitude of Task Improvement
TDI01-Change in Moderate
6 STUDYX QS P0002 3 TDI0103 TDI 2 2
Magnitude of Effort Improvement

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 CDISC SDTM TDI Questionnaire Supplement (Version 1.0)

ROW QSEVAL VISITNUM QSDTC

1 (cont) INVESTIGATOR 2 2013-08-28

2 (cont) INVESTIGATOR 2 2013-08-28

3 (cont) INVESTIGATOR 2 2013-08-28

4 (cont) INVESTIGATOR 2 2013-09-03

5 (cont) INVESTIGATOR 2 2013-09-03

6 (cont) INVESTIGATOR 2 2013-09-03

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 CDISC SDTM TDI Questionnaire Supplement (Version 1.0)

4 SDTM Mapping Strategy

TDI specific mapping strategy: This section is used for reference with the annotated CRF for
further details on the CRF data capture and to understand the alignment of the questionnaire to
the SDTM QS domain. It also provides guidance on how the result variables (QSORRES,
QSSTRESC, and QSSTRESN) should be populated for the questionnaire.

QSTESTCD = TDI0101 QSTEST = TDI01-Change in Functional Impairment

QSTESTCD = TDI0102 QSTEST = TDI01-Change in Magnitude of Task
QSTESTCD = TDI0103 QSTEST = TDI01-Change in Magnitude of Effort

QSORRES QSSTRESC QSSTRESN

Major Deterioration -3 -3
Moderate Deterioration -2 -2
Minor Deterioration -1 -1
No Change 0 0
Minor Improvement 1 1
Moderate Improvement 2 2
Major Improvement 3 3
Further Impairment for Reasons Other than Shortness
Z
of Breath

End of Document

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