CDISC SDTM SGRQ-C Questionnaire Supplement (Version 1.0)
St. George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients (SGRQ-C) Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by CDISC Questionnaires 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 2013-12-18
Version 1.0
2014-02-19
1.0
Summary of Changes St. George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients (SGRQ-C) DRAFT St. George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients (SGRQ-C)
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved
February 19, 2014
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CDISC SDTM SGRQ-C Questionnaire Supplement (Version 1.0)
1
Introduction
This document describes the CDISC implementation of the St. George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients (SGRQ-C), a 40-item version of the original 50-item SGRQ that was derived from the original version following a detailed analysis of data from large studies in COPD. The SGRQ-C preceded the CDISC CDASH CRF standards and cannot be modified to CDASH standards. The representation of data collected for this scale is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: (http://www.cdisc.org/sdtm). The specific implementation details for this scale/questionnaire are meant to be used in conjunction with the SDTMIG. All scale/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 SGRQ-C 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 form 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 at: (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 Jones PW, Quirk FH, Baveystock CM, and Littlejohns PA. Self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun; 145(6):1321-7, for the agreement to include the SGRQ-C in the CDISC data standards.
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved
February 19, 2014
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CDISC SDTM SGRQ-C 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 St. George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients are listed below. St. George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients (SGRQ-C) is a 40-item version of the original 50-item SGRQ that was derived from the original version following a detailed analysis of data from large studies in COPD. The questionnaire consists of two parts. Part 1 (Questions 1-7) addresses the frequency of respiratory symptoms. Part 2 (Questions 8-14) addresses the patient’s current state (i.e. how they are these days). The general scale on the front page is not part of the SGRQ-C, but some investigators find it useful as an additional global measure. 1. SGRQ-C is designed for supervised self-administration. This means that the patients should complete the questionnaire themselves, but someone should be available to give advice if required. The questionnaire evaluator, STUDY SUBJECT, should be stored in QSEVAL. 2. Response scores are not included in the SGRQ-C QS SDTM data set as they rely on a separate scoring supplement and may involve algorithms that are better suited for an analysis data set. Sponsors should therefore implement response scoring in ADaM. The Numeric Finding in Standard Units (QSSTRESN) has been omitted from the example and mapping strategy since the variable is permissible and missing for all records. 3. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for qualifier and result fields is provided in Section 4: SDTM Mapping Strategy.
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved
February 19, 2014
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CDISC SDTM SGRQ-C Questionnaire Supplement (Version 1.0)
3.2
Example for St. George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients (SGRQ-C) QS Domain Model The SGRQ-C example below shows the terminology used to implement the scale in the QS domain. This example shows the data for a subject collected at one visit. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. Rows 1-41: Represent the SGRQ-C results for a subject. All original results are represented with preferred terminology in QSORRES. Answers are not associated with a numeric score, so QSSTRESC is copied from QSORRES, and QSSTRESN has been omitted since the variable is permissible and missing for all records. In this example, these results represent baseline values and are flagged accordingly with QSBLFL. QS.XPT Row
STUDYID
DOMAIN
USUBJID
QSSEQ
QSTESTCD
1
STUDYX
QS
P101
1
SGRQC101
SGRQC1-Describe Your Current Health
SGRQ-C
2
STUDYX
QS
P101
2
SGRQC102
SGRQC1-I Cough
SGRQ-C
3
STUDYX
QS
P101
3
SGRQC103
SGRQC1-I Bring Up Phlegm
SGRQ-C
4
STUDYX
QS
P101
4
SGRQC104
SGRQC1-I Have Shortness of Breath
SGRQ-C
5
STUDYX
QS
P101
5
SGRQC105
SGRQC1-I Have Attacks of Wheezing
SGRQ-C
6
STUDYX
QS
P101
6
SGRQC106
SGRQC1-How Many Respiratory Attacks
SGRQ-C
7
STUDYX
QS
P101
7
SGRQC107
SGRQC1-How Often Do You Have Good Days
SGRQ-C
8
STUDYX
QS
P101
8
SGRQC108
SGRQC1-Wheeze Worse in the Morning
SGRQ-C
9
STUDYX
QS
P101
9
SGRQC109
SGRQC1-Describe Your Resp Problems
SGRQ-C
10
STUDYX
QS
P101
10
SGRQC110
SGRQC1-Washing or Dressing Yourself
SGRQ-C
11
STUDYX
QS
P101
11
SGRQC111
SGRQC1-Walking Around the House
SGRQ-C
12
STUDYX
QS
P101
12
SGRQC112
SGRQC1-Walking Outside on Level Ground
SGRQ-C
13
STUDYX
QS
P101
13
SGRQC113
SGRQC1-Walking Up a Flight of Stairs
SGRQ-C
14
STUDYX
QS
P101
14
SGRQC114
SGRQC1-Walking Up Hills
SGRQ-C
15
STUDYX
QS
P101
15
SGRQC115
SGRQC1-Coughing Hurts
SGRQ-C
16
STUDYX
QS
P101
16
SGRQC116
SGRQC1-Coughing Makes Me Tired
SGRQ-C
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved
February 19, 2014
QSTEST
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QSCAT
CDISC SDTM SGRQ-C Questionnaire Supplement (Version 1.0)
Row
STUDYID
DOMAIN
USUBJID
QSSEQ
QSTESTCD
17
STUDYX
QS
P101
17
SGRQC117
SGRQC1-Short of Breath When Talk
SGRQ-C
18
STUDYX
QS
P101
18
SGRQC118
SGRQC1-Short of Breath When Bend Over
SGRQ-C
19
STUDYX
QS
P101
19
SGRQC119
SGRQC1-Coughing Disturbs My Sleep
SGRQ-C
20
STUDYX
QS
P101
20
SGRQC120
SGRQC1-Get Exhausted Easily
SGRQ-C
21
STUDYX
QS
P101
21
SGRQC121
SGRQC1-Cough Is Embarrassing in Public
SGRQ-C
22
STUDYX
QS
P101
22
SGRQC122
SGRQC1-Respiratory Problems a Nuisance
SGRQ-C
23
STUDYX
QS
P101
23
SGRQC123
SGRQC1-Afraid When Cannot Catch Breath
SGRQ-C
24
STUDYX
QS
P101
24
SGRQC124
SGRQC1-Not in Control of Resp Problems
SGRQ-C
25
STUDYX
QS
P101
25
SGRQC125
SGRQC1-Frail Because of Resp Problems
SGRQ-C
26
STUDYX
QS
P101
26
SGRQC126
SGRQC1-Exercise Is Not Safe for Me
SGRQ-C
27
STUDYX
QS
P101
27
SGRQC127
SGRQC1-Everything Too Much Effort
SGRQ-C
28
STUDYX
QS
P101
28
SGRQC128
SGRQC1-Take a Long Time to Get Washed
SGRQ-C
29
STUDYX
QS
P101
29
SGRQC129
SGRQC1-Cannot Take a Bath or Shower
SGRQ-C
30
STUDYX
QS
P101
30
SGRQC130
SGRQC1-Walk Slow Than Others My Age
SGRQ-C
31
STUDYX
QS
P101
31
SGRQC131
SGRQC1-Jobs Take a Long Time
SGRQ-C
32
STUDYX
QS
P101
32
SGRQC132
SGRQC1-Walk Up Flight of Stairs Slowly
SGRQ-C
33
STUDYX
QS
P101
33
SGRQC133
SGRQC1-If I Hurry, I Have to Stop
SGRQ-C
34
STUDYX
QS
P101
34
SGRQC134
SGRQC1-Difficult to Walk Up Hills
SGRQ-C
35
STUDYX
QS
P101
35
SGRQC135
SGRQC1-Difficult to Carry Heavy Loads
SGRQ-C
36
STUDYX
QS
P101
36
SGRQC136
SGRQC1-Cannot Play Sports
SGRQ-C
37
STUDYX
QS
P101
37
SGRQC137
SGRQC1-Cannot Go Out for Entertainment
SGRQ-C
38
STUDYX
QS
P101
38
SGRQC138
SGRQC1-Cannot Go Out to Do Shopping
SGRQ-C
39
STUDYX
QS
P101
39
SGRQC139
SGRQC1-Cannot Do Household Chores
SGRQ-C
40
STUDYX
QS
P101
40
SGRQC140
SGRQC1-Cannot Move Far From My Bed
SGRQ-C
41
STUDYX
QS
P101
41
SGRQC141
SGRQC1-How Resp Problems Affect You
SGRQ-C
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved
February 19, 2014
QSTEST
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QSCAT
CDISC SDTM SGRQ-C Questionnaire Supplement (Version 1.0)
Row
QSORRES
QSSTRESC
QSBLFL
QSEVAL
VISITNUM
QSDTC
1 (cont)
Fair
Fair
Y
STUDY SUBJECT
2
2012-03-21
2 (cont)
several days a week
several days a week
Y
STUDY SUBJECT
2
2012-03-21
3 (cont)
only with respiratory infections
only with respiratory infections
Y
STUDY SUBJECT
2
2012-03-21
4 (cont)
several days a week
several days a week
Y
STUDY SUBJECT
2
2012-03-21
5 (cont)
a few days a month
a few days a month
Y
STUDY SUBJECT
2
2012-03-21
6 (cont)
1 or 2 attacks
1 or 2 attacks
Y
STUDY SUBJECT
2
2012-03-21
7 (cont)
a few good days
a few good days
Y
STUDY SUBJECT
2
2012-03-21
8 (cont)
Yes
Y
Y
STUDY SUBJECT
2
2012-03-21
9 (cont)
Cause me a few problems
Cause me a few problems
Y
STUDY SUBJECT
2
2012-03-21
10 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
11 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
12 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
13 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
14 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
15 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
16 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
17 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
18 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
19 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
20 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
21 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
22 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
23 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
24 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
25 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
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QSEVLINT
-P1Y
CDISC SDTM SGRQ-C Questionnaire Supplement (Version 1.0)
Row
QSORRES
QSSTRESC
QSBLFL
QSEVAL
VISITNUM
QSDTC
26 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
27 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
28 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
29 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
30 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
31 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
32 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
33 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
34 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
35 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
36 (cont)
True
True
Y
STUDY SUBJECT
2
2012-03-21
37 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
38 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
39 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
40 (cont)
False
False
Y
STUDY SUBJECT
2
2012-03-21
41 (cont)
They stop me from doing one or two things I would like to do
They stop me from doing one or two things I would like to do
Y
STUDY SUBJECT
2
2012-03-21
© 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved
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Page 7
QSEVLINT
CDISC SDTM SGRQ-C Questionnaire Supplement (Version 1.0)
4 SDTM Mapping Strategy SGRQ-C 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 results variables (QSORRES and QSSTRESC) should be populated for the scale. QSSTRESN has been omitted since the variable is permissible and missing for all values. QSTESTCD=SGRQC101 QSTEST=SGRQC1-Describe Your Current Health QSORRES
QSSTRESC
Very good
Very good
Good
Good
Fair
Fair
Poor
Poor
Very poor
Very poor
QSTESTCD=SGRQC102 QSTEST=SGRQC1-I Cough QSTESTCD=SGRQC103 QSTEST=SGRQC1-I Bring Up Phlegm QSORRES QSSTRESC most days a week most days a week several days a week
several days a week
only with respiratory infections
only with respiratory infections
not at all
not at all
QSTESTCD=SGRQC104 QSTEST=SGRQC1-I Have Shortness of Breath QSORRES QSSTRESC most days a week
most days a week
several days a week
several days a week
not at all
not at all
QSTESTCD=SGRQC105 QSTEST=SGRQC1-I Have Attacks of Wheezing QSORRES QSSTRESC most days a week most days a week several days a week
several days a week
a few days a month
a few days a month
only with respiratory infections
only with respiratory infections
not at all
not at all
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CDISC SDTM MMRC Questionnaire Supplement (Version 1.0)
QSTESTCD=SGRQC106 QSTEST=SGRQC1-How Many Respiratory Attacks QSORRES QSSTRESC 3 or more attacks 3 or more attacks 1 or 2 attacks
1 or 2 attacks
none
none
QSTESTCD=SGRQC107 QSTEST=SGRQC1-How Often Do You Have Good Days QSORRES QSSTRESC no good days no good days a few good days
a few good days
most days are good
most days are good
every day is good
every day is good
QSTESTCD=SGRQC108 QSTEST=SGRQC1-Wheeze Worse in the Morning QSORRES QSSTRESC No N Yes
Y
QSTESTCD=SGRQC109 QSTEST=SGRQC1-Describe Your Resp Problems QSORRES QSSTRESC Cause me a lot of problems or are the Cause me a lot of problems or are the most important physical problem I have most important physical problem I have Cause me a few problems Cause me a few problems Cause no problems QSTESTCD=SGRQC110 QSTESTCD=SGRQC111 QSTESTCD=SGRQC112 QSTESTCD=SGRQC113 QSTESTCD=SGRQC114 QSTESTCD=SGRQC115 QSTESTCD=SGRQC116 QSTESTCD=SGRQC117 QSTESTCD=SGRQC118 QSTESTCD=SGRQC119 QSTESTCD=SGRQC120 QSTESTCD=SGRQC121 QSTESTCD=SGRQC122 QSTESTCD=SGRQC123 QSTESTCD=SGRQC124 QSTESTCD=SGRQC125 QSTESTCD=SGRQC126 QSTESTCD=SGRQC127 QSTESTCD=SGRQC128
Cause no problems QSTEST=SGRQC1-Washing or Dressing Yourself QSTEST=SGRQC1-Walking Around the House QSTEST=SGRQC1-Walking Outside on Level Ground QSTEST=SGRQC1-Walking Up a Flight of Stairs QSTEST=SGRQC1-Walking Up Hills QSTEST=SGRQC1-Coughing Hurts QSTEST=SGRQC1-Coughing Makes Me Tired QSTEST=SGRQC1-Short of Breath When Talk QSTEST=SGRQC1-Short of Breath When Bend Over QSTEST=SGRQC1-Coughing Disturbs My Sleep QSTEST=SGRQC1-Get Exhausted Easily QSTEST=SGRQC1-Cough Is Embarrassing in Public QSTEST=SGRQC1-Respiratory Problems a Nuisance QSTEST=SGRQC1-Afraid When Cannot Catch Breath QSTEST=SGRQC1-Not in Control of Resp Problems QSTEST=SGRQC1-Frail Because of Resp Problems QSTEST=SGRQC1-Exercise Is Not Safe for Me QSTEST=SGRQC1-Everything Too Much Effort QSTEST=SGRQC1-Take a Long Time to Get Washed
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February 19, 2014
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CDISC SDTM MMRC Questionnaire Supplement (Version 1.0)
QSTESTCD=SGRQC129 QSTESTCD=SGRQC130 QSTESTCD=SGRQC131 QSTESTCD=SGRQC132 QSTESTCD=SGRQC133 QSTESTCD=SGRQC134 QSTESTCD=SGRQC135 QSTESTCD=SGRQC136 QSTESTCD=SGRQC137 QSTESTCD=SGRQC138 QSTESTCD=SGRQC139 QSTESTCD=SGRQC140 QSORRES True False
QSTEST=SGRQC1-Cannot Take a Bath or Shower QSTEST=SGRQC1-Walk Slow Than Others My Age QSTEST=SGRQC1-Jobs Take a Long Time QSTEST=SGRQC1-Walk Up Flight of Stairs Slowly QSTEST=SGRQC1-If I Hurry, I Have to Stop QSTEST=SGRQC1-Difficult to Walk Up Hills QSTEST=SGRQC1-Difficult to Carry Heavy Loads QSTEST=SGRQC1-Cannot Play Sports QSTEST=SGRQC1-Cannot Go Out for Entertainment QSTEST=SGRQC1-Cannot Go Out to Do Shopping QSTEST=SGRQC1-Cannot Do Household Chores QSTEST=SGRQC1-Cannot Move Far From My Bed QSSTRESC True False
QSTESTCD=SGRQC141 QSTEST=SGRQC1-How Resp Problems Affect You QSORRES QSSTRESC They do not stop me from doing They do not stop me from doing anything I would like to do anything I would like to do They stop me from doing one or They stop me from doing one or two two things I would like to do things I would like to do They stop me from doing most They stop me from doing most of the of the things I would like to do things I would like to do They stop me from doing They stop me from doing everything I everything I would like to do would like to do
End of Document
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