© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1
October 30, 2013
Functional Assessment of Multiple Sclerosis
(FAMS)
Questionnaire Supplement to the Study Data
Tabulation Model Implementation Guide
for Human Clinical Trials
Prepared by
Multiple Sclerosis Outcomes Assessment Consortium and the 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
2013-10-17 1.0 Functional Assessment of Multiple Sclerosis (FAMS) Draft
2013-10-30 1.0 Functional Assessment of Multiple Sclerosis (FAMS)
CDISC SDTM FAMS Questionnaire Supplement (Version 1.0)
© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2
October 30, 2013
1 Introduction
This document describes the CDISC implementation of the Functional Assessment of Multiple Sclerosis (FAMS) questionnaire, a disease-specific self-report questionnaire that investigates six
primary aspects of quality of life in patients with Multiple Sclerosis. The FAMS questionnaire preceded the CDISC CDASH CRF standards and based on its
copyrighted 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 This instrument is copyright approved. CDISC has included the Functional Assessment of Multiple
Sclerosis (FAMS) as part of CDISC Data Standards. Hence, CDISC developed QSTESTCD and QSTEST for each question based on the actual question text on the questionnaire. There may be
many versions of this questionnaire in the public domain or copyright questionnaire. CDISC has chosen to use this version as the data standard.
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 that the FAMS questionnaire and all related subscales, translations, and
adaptations (“FACIT System”) are owned and copyrighted by David Cella, Ph.D. The ownership and copyright of the FACIT System resides strictly with Dr. Cella. Dr. Cella has granted FACIT.org the right to license usage of the FACIT System to other parties.
CDISC SDTM FAMS Questionnaire Supplement (Version 1.0)
© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3
October 30, 2013
The reference for this questionnaire is:
Cella et al. Validation of the Functional Assessment of Multiple Sclerosis quality of life instrument. NEUROLOGY 1996;47: 129-139.
CDISC SDTM FAMS Questionnaire Supplement (Version 1.0)
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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 Functional Assessment of Multiple Sclerosis questionnaire are listed below.
Functional Assessment of Multiple Sclerosis (FAMS): FAMS is a disease-specific self-report questionnaire that investigates six primary aspects of quality of life in patients with Multiple
Sclerosis. It consists of 58 items, each rated on a 5-point scale.
1. These 58 CRF questions are grouped into sub-categories (QSSCAT) as MOBILITY, SYMPTOMS, EMOTIONAL WELL-BEING, GENERAL CONTENTMENT,
THINKING AND FATIGUE, FAMILY/SOCIAL WELL-BEING, and ADDITIONAL CONCERNS.
2. The questionnaire evaluator should be stored in QSEVAL. For FAMS, the evaluator is usually defined as STUDY SUBJECT.
3. The time period of evaluation for the FAMS is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. Typically,
the evaluation interval for FAMS is the past 7 days.
4. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for qualifier, timing, and result fields is provided in Section 4:
SDTM Mapping Strategy.
CDISC SDTM FAMS Questionnaire Supplement (Version 1.0)
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3.2 Example for Functional Assessment of Multiple Sclerosis (FAMS) QS Domain Model
The FAMS example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for one
subject collected at the baseline visit for a FAMS questionnaire. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. This example is based on a questionnaire with an evaluation interval of the past 7 days. QSBLFL is Y based on VISITNUM=1. All
original results are represented with preferred terminology in QSORRES. This result is then transformed into a standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.
Rows 1-58: Represent the questions from the FAMS CRF. The evaluation interval for FAMS is the past 7 days, which is stored in QSEVLINT in ISO format.
qs.xpt Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SSCAT Q SO RRES Q SSTRESC Q SSTRESN
1 STUDYX QS P0001 1 FAMS0101 FAMS01-Trouble Meeting Needs of Family FAMS MOBILITY Somewhat 2 2
2 STUDYX QS P0001 2 FAMS0102 FAMS01-I Am Able to Work FAMS MOBILITY A litt le bit 1 1
3 STUDYX QS P0001 3 FAMS0103 FAMS01-I Have Trouble Walking FAMS MOBILITY Quite a bit 3 3
4 STUDYX QS P0001 4 FAMS0104 FAMS01-Limit My Social Activity FAMS MOBILITY Somewhat 2 2
5 STUDYX QS P0001 5 FAMS0105 FAMS01-I Have Strength in My Legs FAMS MOBILITY A litt le bit 1 1
6 STUDYX QS P0001 6 FAMS0106 FAMS01-Trouble Getting Around in Public FAMS MOBILITY Quite a bit 3 3
7 STUDYX QS P0001 7 FAMS0107 FAMS01-Take My Condition Into Account FAMS MOBILITY Very much 4 4
8 STUDYX QS P0001 8 FAMS0108 FAMS01-I Have Nausea FAMS SYMPTOMS Not at all 0 0
9 STUDYX QS P0001 9 FAMS0109 FAMS01-I Have Pain FAMS SYMPTOMS A litt le bit 1 1
10 STUDYX QS P0001 10 FAMS0110 FAMS01-I Feel Ill FAMS SYMPTOMS Somewhat 2 2
11 STUDYX QS P0001 11 FAMS0111 FAMS01-I Feel Weak All Over FAMS SYMPTOMS Somewhat 2 2
12 STUDYX QS P0001 12 FAMS0112 FAMS01-I Have Pain in My Joints FAMS SYMPTOMS A litt le bit 1 1
13 STUDYX QS P0001 13 FAMS0113 FAMS01-I Am Bothered by Headaches FAMS SYMPTOMS Not at all 0 0
14 STUDYX QS P0001 14 FAMS0114 FAMS01-I Am Bothered by Muscle Pains FAMS SYMPTOMS A litt le bit 1 1
15 STUDYX QS P0001 15 FAMS0115 FAMS01-I Feel Sad FAMS EMOTIONAL
WELL-BEING A litt le bit 1 1
16 STUDYX QS P0001 16 FAMS0116 FAMS01-Losing Hope Against Illness FAMS EMOTIONAL
WELL-BEING A litt le bit 1 1
17 STUDYX QS P0001 17 FAMS0117 FAMS01-I Am Able to Enjoy Life FAMS EMOTIONAL
WELL-BEING Quite a bit 3 3
18 STUDYX QS P0001 18 FAMS0118 FAMS01-I Feel Trapped by My Condition FAMS EMOTIONAL
WELL-BEING Somewhat 2 2
19 STUDYX QS P0001 19 FAMS0119 FAMS01-I Am Depressed About My Condition FAMS EMOTIONAL
WELL-BEING A litt le bit 1 1
CDISC SDTM FAMS Questionnaire Supplement (Version 1.0)
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Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SSCAT Q SO RRES Q SSTRESC Q SSTRESN
20 STUDYX QS P0001 20 FAMS0120 FAMS01-I Feel Useless FAMS EMOTIONAL WELL-BEING
Somewhat 2 2
21 STUDYX QS P0001 21 FAMS0121 FAMS01-Feel Overwhelmed by My Condition FAMS EMOTIONAL WELL-BEING
Quite a bit 3 3
22 STUDYX QS P0001 22 FAMS0122 FAMS01-My Work Is Fulfilling FAMS GENERAL
CONTENTMENT Very much 4 4
23 STUDYX QS P0001 23 FAMS0123 FAMS01-I Have Accepted My Illness FAMS GENERAL
CONTENTMENT Quite a bit 3 3
24 STUDYX QS P0001 24 FAMS0124 FAMS01-Enjoy Things I Usually Do for Fun FAMS GENERAL
CONTENTMENT Quite a bit 3 3
25 STUDYX QS P0001 25 FAMS0125 FAMS01-Content With Quality of My Life FAMS GENERAL
CONTENTMENT Somewhat 2 2
26 STUDYX QS P0001 26 FAMS0126 FAMS01-I Am Frustrated by My Condition FAMS GENERAL
CONTENTMENT Somewhat 2 2
27 STUDYX QS P0001 27 FAMS0127 FAMS01-Feel Sense of Purpose in My Life FAMS GENERAL
CONTENTMENT A litt le bit 1 1
28 STUDYX QS P0001 28 FAMS0128 FAMS01-I Feel Motivated to Do Things FAMS GENERAL
CONTENTMENT Somewhat 2 2
29 STUDYX QS P0001 29 FAMS0129 FAMS01-I Have a Lack of Energy FAMS THINKING AND
FATIGUE Somewhat 2 2
30 STUDYX QS P0001 30 FAMS0130 FAMS01-I Feel T ired FAMS THINKING AND
FATIGUE A litt le bit 1 1
31 STUDYX QS P0001 31 FAMS0131 FAMS01-Trouble Starting Things FAMS THINKING AND
FATIGUE A litt le bit 1 1
32 STUDYX QS P0001 32 FAMS0132 FAMS01-Trouble Finishing Things FAMS THINKING AND
FATIGUE A litt le bit 1 1
33 STUDYX QS P0001 33 FAMS0133 FAMS01-I Need to Rest During the Day FAMS THINKING AND
FATIGUE Somewhat 2 2
34 STUDYX QS P0001 34 FAMS0134 FAMS01-I Have Trouble Remembering Things FAMS THINKING AND
FATIGUE Not at all 0 0
35 STUDYX QS P0001 35 FAMS0135 FAMS01-I Have Trouble Concentrating FAMS THINKING AND
FATIGUE Not at all 0 0
36 STUDYX QS P0001 36 FAMS0136 FAMS01-My Thinking Is Slower Than Before FAMS THINKING AND
FATIGUE Not at all 0 0
37 STUDYX QS P0001 37 FAMS0137 FAMS01-I Have Trouble Learning New Tasks FAMS THINKING AND
FATIGUE Not at all 0 0
38 STUDYX QS P0001 38 FAMS0138 FAMS01-I Feel Close to My Friends FAMS FAMILY/SOCIAL
WELL-BEING Very much 4 4
39 STUDYX QS P0001 39 FAMS0139 FAMS01-Get Emotional Support From Family FAMS FAMILY/SOCIAL
WELL-BEING Very much 4 4
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Row STUDYID DO MAIN USUBJID Q SSEQ Q STESTCD Q STEST Q SCAT Q SSCAT Q SO RRES Q SSTRESC Q SSTRESN
40 STUDYX QS P0001 40 FAMS0140 FAMS01-I Get Support From My Friends FAMS FAMILY/SOCIAL
WELL-BEING Very much 4 4
41 STUDYX QS P0001 41 FAMS0141 FAMS01-My Family Has Accepted My Illness FAMS FAMILY/SOCIAL
WELL-BEING Somewhat 2 2
42 STUDYX QS P0001 42 FAMS0142 FAMS01-Satisfied Communication Illness FAMS FAMILY/SOCIAL
WELL-BEING Somewhat 2 2
43 STUDYX QS P0001 43 FAMS0143 FAMS01-Trouble Understanding Worsening FAMS FAMILY/SOCIAL
WELL-BEING A litt le bit 1 1
44 STUDYX QS P0001 44 FAMS0144 FAMS01-I Feel Left Out of Things FAMS FAMILY/SOCIAL
WELL-BEING A litt le bit 1 1
45 STUDYX QS P0001 45 FAMS0145 FAMS01-Bothered by Treatment Side Effect FAMS ADDITIONAL
CONCERNS A litt le bit 1 1
46 STUDYX QS P0001 46 FAMS0146 FAMS01-I Am Forced to Spend Time in Bed FAMS ADDITIONAL
CONCERNS Somewhat 2 2
47 STUDYX QS P0001 47 FAMS0147 FAMS01-I Feel Close to My Partner FAMS ADDITIONAL
CONCERNS Very much 4 4
48 STUDYX QS P0001 48 FAMS0148 FAMS01-I Am Satisfied With My Sex Life FAMS ADDITIONAL
CONCERNS Quite a bit 3 3
49 STUDYX QS P0001 49 FAMS0149 FAMS01-Satisfied With How I Am Coping FAMS ADDITIONAL
CONCERNS Quite a bit 3 3
50 STUDYX QS P0001 50 FAMS0150 FAMS01-I Feel Nervous FAMS ADDITIONAL
CONCERNS A litt le bit 1 1
51 STUDYX QS P0001 51 FAMS0151 FAMS01-Worry My Condition Will Get Worse FAMS ADDITIONAL
CONCERNS Quite a bit 3 3
52 STUDYX QS P0001 52 FAMS0152 FAMS01-I Am Sleeping Well FAMS ADDITIONAL
CONCERNS Quite a bit 3 3
53 STUDYX QS P0001 53 FAMS0153 FAMS01-Heat Worsens My Symptoms FAMS ADDITIONAL
CONCERNS A litt le bit 1 1
54 STUDYX QS P0001 54 FAMS0154 FAMS01-Have Trouble Controlling My Urine FAMS ADDITIONAL
CONCERNS Not at all 0 0
55 STUDYX QS P0001 55 FAMS0155 FAMS01-I Urinate More Frequently FAMS ADDITIONAL
CONCERNS Not at all 0 0
56 STUDYX QS P0001 56 FAMS0156 FAMS01-I Am Bothered by the Chills FAMS ADDITIONAL
CONCERNS A litt le bit 1 1
57 STUDYX QS P0001 57 FAMS0157 FAMS01-I Am Bothered by Fevers FAMS ADDITIONAL
CONCERNS A litt le bit 1 1
58 STUDYX QS P0001 58 FAMS0158 FAMS01-I Am Bothered by Muscle Spasms FAMS ADDITIONAL
CONCERNS Somewhat 2 2
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qs.xpt (cont) Row Q SBLFL Q SEVAL VISITNUM Q SDTC Q SEVLINT
1 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
2 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
3 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
4 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
5 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
6 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
7 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
8 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
9 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
10 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
11 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
12 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
13 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
14 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
15 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
16 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
17 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
18 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
19 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
20 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
21 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
22 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
23 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
24 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
25 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
26 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
27 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
28 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
29 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
30 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
31 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
32 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
33 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
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34 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
35 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
36 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
37 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
38 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
39 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
40 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
41 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
42 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
43 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
44 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
45 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
46 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
47 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
48 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
49 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
50 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
51 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
52 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
53 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
54 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
55 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
56 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
57 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
58 (cont) Y STUDY SUBJECT 1 2012-11-16 -P7D
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4 SDTM Mapping Strategy
FAMS 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.
All QSTESTCDs
QSORRES QSSTRESC QSSTRESN Not at all 0 0
A little bit 1 1
Somewhat 2 2 Quite a bit 3 3
Very much 4 4
QSSCAT=MOBILITY
QSTESTCD QSTEST
FAMS0101 FAMS01-Trouble Meeting Needs of Family FAMS0102 FAMS01-I Am Able to Work
FAMS0103 FAMS01-I Have Trouble Walking FAMS0104 FAMS01-Limit My Social Activity
FAMS0105 FAMS01-I Have Strength in My Legs FAMS0106 FAMS01-Trouble Getting Around in Public
FAMS0107 FAMS01-Take My Condition Into Account
QSSCAT=SYMPTOMS
QSTESTCD QSTEST
FAMS0108 FAMS01-I Have Nausea FAMS0109 FAMS01-I Have Pain
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FAMS0110 FAMS01-I Feel Ill FAMS0111 FAMS01-I Feel Weak All Over
FAMS0112 FAMS01-I Have Pain in My Joints FAMS0113 FAMS01-I Am Bothered by Headaches
FAMS0114 FAMS01-I Am Bothered By Muscle Pains
QSSCAT=EMOTIONAL WELL-BEING
QSTESTCD QSTEST
FAMS0115 FAMS01-I Feel Sad FAMS0116 FAMS01-Losing Hope Against Illness
FAMS0117 FAMS01-I Am Able to Enjoy Life FAMS0118 FAMS01-I Feel Trapped by My Condition
FAMS0119 FAMS01-I Am Depressed About My Condition FAMS0120 FAMS01-I Feel Useless
FAMS0121 FAMS01-Feel Overwhelmed by My Condition
QSSCAT=GENERAL CONTENTMENT
QSTESTCD QSTEST FAMS0122 FAMS01-My Work Is Fulfilling
FAMS0123 FAMS01-I Have Accepted My Illness FAMS0124 FAMS01-Enjoy Things I Usually Do for Fun
FAMS0125 FAMS01-Content With Quality of My Life
FAMS0126 FAMS01-I Am Frustrated by My Condition FAMS0127 FAMS01-Feel Sense of Purpose in My Life
FAMS0128 FAMS01-I Feel Motivated to Do Things
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QSSCAT=THINKING AND FATIGUE
QSTESTCD QSTEST
FAMS0129 FAMS01-I Have a Lack of Energy FAMS0130 FAMS01-I Feel Tired
FAMS0131 FAMS01-Trouble Starting Things
FAMS0132 FAMS01-Trouble Finishing Things FAMS0133 FAMS01-I Need to Rest During the Day
FAMS0134 FAMS01-I Have Trouble Remembering Things FAMS0135 FAMS01-I Have Trouble Concentrating
FAMS0136 FAMS01-My Thinking Is Slower Than Before FAMS0137 FAMS01-I Have Trouble Learning New Tasks
QSSCAT=FAMILY/SOCIAL WELL-BEING
QSTESTCD QSTEST
FAMS0138 FAMS01-I Feel Close to My Friends FAMS0139 FAMS01-Get Emotional Support From Family
FAMS0140 FAMS01-I Get Support From My Friends
FAMS0141 FAMS01-My Family Has Accepted My Illness FAMS0142 FAMS01-Satisfied Communication Illness
FAMS0143 FAMS01-Trouble Understanding Worsening FAMS0144 FAMS01-I Feel Left Out of Things
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QSSCAT=ADDITIONAL CONCERNS
QSTESTCD QSTEST
FAMS0145 FAMS01-Bothered by Treatment Side Effect FAMS0146 FAMS01-I Am Forced to Spend Time in Bed
FAMS0147 FAMS01-I Feel Close to My Partner
FAMS0148 FAMS01-I Am Satisfied With My Sex Life FAMS0149 FAMS01-Satisfied With How I Am Coping
FAMS0150 FAMS01-I Feel Nervous FAMS0151 FAMS01-Worry My Condition Will Get Worse
FAMS0152 FAMS01-I Am Sleeping Well FAMS0153 FAMS01-Heat Worsens My Symptoms
FAMS0154 FAMS01-Have Trouble Controlling My Urine FAMS0155 FAMS01-I Urinate More Frequently
FAMS0156 FAMS01-I Am Bothered by the Chills FAMS0157 FAMS01-I Am Bothered by Fevers
FAMS0158 FAMS01-I Am Bothered by Muscle Spasms
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The FAMS is part of the FACIT system of scales and symptom indexes. The FACIT system uses the same FACIT code across multiple instruments. In order to compare these similar questions across disease areas or medical conditions, each question of the FAMS has a FACIT code that can be matched with the same question in other FACIT scales. These codes are not included as part of
the CDISC QS terminology, but are included below for reference.
FACIT Code QSTESTCD QSTEST QSSCAT GP3 FAMS0101 FAMS01-Trouble Meeting Needs of Family QSSCAT=MOBILITY
GF1 FAMS0102 FAMS01-I Am Able to Work QSSCAT=MOBILITY An6 FAMS0103 FAMS01-I Have Trouble Walking QSSCAT=MOBILITY
ITU3 FAMS0104 FAMS01-Limit My Social Activity QSSCAT=MOBILITY CNS5 FAMS0105 FAMS01-I Have Strength in My Legs QSSCAT=MOBILITY
MS1 FAMS0106 FAMS01-Trouble Getting Around in Public QSSCAT=MOBILITY MS2 FAMS0107 FAMS01-Take My Condition Into Account QSSCAT=MOBILITY
GP2 FAMS0108 FAMS01-I Have Nausea QSSCAT=SYMPTOMS GP4 FAMS0109 FAMS01-I Have Pain QSSCAT=SYMPTOMS
GP6 FAMS0110 FAMS01-I Feel Ill QSSCAT=SYMPTOMS HI12 FAMS0111 FAMS01-I Feel Weak All Over QSSCAT=SYMPTOMS
BRM1 FAMS0112 FAMS01-I Have Pain in My Joints QSSCAT=SYMPTOMS
MS3 FAMS0113 FAMS01-I Am Bothered by Headaches QSSCAT=SYMPTOMS MS4 FAMS0114 FAMS01-I Am Bothered by Muscle Pains QSSCAT=SYMPTOMS
GE1 FAMS0115 FAMS01-I Feel Sad QSSCAT=EMOTIONAL WELL-BEING GE3 FAMS0116 FAMS01-Losing Hope Against Illness QSSCAT=EMOTIONAL WELL-BEING
GF3 FAMS0117 FAMS01-I Am Able to Enjoy Life QSSCAT=EMOTIONAL WELL-BEING MS5 FAMS0118 FAMS01-I Feel Trapped by My Condition QSSCAT=EMOTIONAL WELL-BEING
MS6 FAMS0119 FAMS01-I Am Depressed About My
Condition QSSCAT=EMOTIONAL WELL-BEING
MS7 FAMS0120 FAMS01-I Feel Useless QSSCAT=EMOTIONAL WELL-BEING
MS8 FAMS0121 FAMS01-Feel Overwhelmed by My
Condition QSSCAT=EMOTIONAL WELL-BEING
GF2 FAMS0122 FAMS01-My Work Is Fulfilling QSSCAT=GENERAL CONTENTMENT
GF4 FAMS0123 FAMS01-I Have Accepted My Illness QSSCAT=GENERAL CONTENTMENT GF6 FAMS0124 FAMS01-Enjoy Things I Usually Do for Fun QSSCAT=GENERAL CONTENTMENT
GF7 FAMS0125 FAMS01-Content With Quality of My Life QSSCAT=GENERAL CONTENTMENT MS9 FAMS0126 FAMS01-I Am Frustrated by My Condition QSSCAT=GENERAL CONTENTMENT
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FACIT Code QSTESTCD QSTEST QSSCAT Sp5 FAMS0127 FAMS01-Feel Sense of Purpose in My Life QSSCAT=GENERAL CONTENTMENT
HI6 FAMS0128 FAMS01-I Feel Motivated to Do Things QSSCAT=GENERAL CONTENTMENT GP1 FAMS0129 FAMS01-I Have a Lack of Energy QSSCAT=THINKING AND FATIGUE
An2 FAMS0130 FAMS01-I Feel Tired QSSCAT=THINKING AND FATIGUE An3 FAMS0131 FAMS01-Trouble Starting Things QSSCAT=THINKING AND FATIGUE
An4 FAMS0132 FAMS01-Trouble Finishing Things QSSCAT=THINKING AND FATIGUE MS10 FAMS0133 FAMS01-I Need to Rest During the Day QSSCAT=THINKING AND FATIGUE
HI9 FAMS0134 FAMS01-I Have Trouble Remembering
Things QSSCAT=THINKING AND FATIGUE HI8 FAMS0135 FAMS01-I Have Trouble Concentrating QSSCAT=THINKING AND FATIGUE
MS11 FAMS0136 FAMS01-My Thinking Is Slower Than
Before QSSCAT=THINKING AND FATIGUE
MS12 FAMS0137 FAMS01-I Have Trouble Learning New
Tasks QSSCAT=THINKING AND FATIGUE
GS1 FAMS0138 FAMS01-I Feel Close to My Friends QSSCAT=FAMILY/SOCIAL WELL-
BEING
GS2 FAMS0139 FAMS01-Get Emotional Support From
Family QSSCAT=FAMILY/SOCIAL WELL-
BEING
GS3 FAMS0140 FAMS01-I Get Support From My Friends QSSCAT=FAMILY/SOCIAL WELL-
BEING
GS4 FAMS0141 FAMS01-My Family Has Accepted My
Illness QSSCAT=FAMILY/SOCIAL WELL-
BEING
GS5 FAMS0142 FAMS01-Satisfied Communication Illness QSSCAT=FAMILY/SOCIAL WELL-
BEING
MS13 FAMS0143 FAMS01-Trouble Understanding Worsening QSSCAT=FAMILY/SOCIAL WELL-
BEING
MS14 FAMS0144 FAMS01-I Feel Left Out of Things QSSCAT=FAMILY/SOCIAL WELL-
BEING GP5 FAMS0145 FAMS01-Bothered by Treatment Side Effect QSSCAT=ADDITONAL CONCERNS
GP7 FAMS0146 FAMS01-I Am Forced to Spend Time in Bed QSSCAT=ADDITONAL CONCERNS GS6 FAMS0147 FAMS01-I Feel Close to My Partner QSSCAT=ADDITONAL CONCERNS
GS7 FAMS0148 FAMS01-I Am Satisfied With My Sex Life QSSCAT=ADDITONAL CONCERNS
GE2 FAMS0149 FAMS01-Satisfied With How I Am Coping QSSCAT=ADDITONAL CONCERNS GE4 FAMS0150 FAMS01-I Feel Nervous QSSCAT=ADDITONAL CONCERNS
CDISC SDTM FAMS Questionnaire Supplement (Version 1.0)
© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 16
October 30, 2013
FACIT Code QSTESTCD QSTEST QSSCAT
GE6 FAMS0151 FAMS01-Worry My Condition Will Get
Worse QSSCAT=ADDITONAL CONCERNS
GF5 FAMS0152 FAMS01-I Am Sleeping Well QSSCAT=ADDITONAL CONCERNS MS15 FAMS0153 FAMS01-Heat Worsens My Symptoms QSSCAT=ADDITONAL CONCERNS
BL1 FAMS0154 FAMS01-Have Trouble Controlling My
Urine QSSCAT=ADDITONAL CONCERNS BL2 FAMS0155 FAMS01-I Urinate More Frequently QSSCAT=ADDITONAL CONCERNS
BRM2 FAMS0156 FAMS01-I Am Bothered by the Chills QSSCAT=ADDITONAL CONCERNS BRM3 FAMS0157 FAMS01-I Am Bothered by Fevers QSSCAT=ADDITONAL CONCERNS
MS16 FAMS0158 FAMS01-I Am Bothered by Muscle Spasms QSSCAT=ADDITONAL CONCERNS
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