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Title

Functional Assessment of Cancer Therapy-Hepatobiliary Version 4 (FACT-HEP V4)

CDISC ReferenceQuestionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

FACT-HEP V4

QRS Permission StatusApproveApproved
TeamPancreatic Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date20022023-1007-28 
Notes
  • 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

DateVersion
20222023-1007-281.0 Draft

© 2022 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Functional Assessment of Cancer Therapy-Hepatobiliary Version 4 (FACT-HEP V4)

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-671
instrument.

CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

...

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG 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.

...

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.  

2 Copyright Status

David Cella, PhD. , owns the copyright for the FACT-HEP V4 instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

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

Info
titleInformation for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

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

These materials discuss and/or include the FACIT Measurement System, which is owned exclusively by Dr. David Cella. No part of the FACIT Measurement System may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Dr. David Cella and payment of any applicable fees. Copyright Dr. David Cella. All rights reserved.  Copyright 1987, 1997 David Cella, PhD.

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

Info
titleInformation for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

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

CDISC acknowledges Dr. David Cella and FACIT.org for CDISC acknowledges Dr. David Cella and FACIT.org, for the approval to include the FACT-HEP V4 in the CDISC data standards.

Reference for the FACT-HEP V4:

  • Copyright 1987, 1997 David Cella, Ph.D.
  • These materials discuss and/or include FACIT Measurement System, which is owned exclusively by Dr. David Cella. No part of the FACIT Measurement System may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Dr. David Cella and payment of any applicable fees. Copyright Dr. David Cella. All rights reserved.
Info

Notes on the use of quotation marks:

  • Use for text values of a Likert scale: e.g., ...with response options ranging from “never” to “daily."
  • Actual numbers of the scale (e.g., 0-3) do not appear in quotation marks while the definitions of these anchors (e.g., 5 = “I always fall asleep”) do.
  • Enclose values for variables within quotation marks (e.g., QSTESTCD = "IPA0102")

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the FACT-HEP V4 are listed below.

The FACT-HEP V4 is a multiple-choice health-related quality of life questionnaire about problems associated with hepatobiliary cancer. It consists of 45 items rated on a 5-point scale.

  1. All items rated on a 5-point scale include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "Not at all", 4 = "Very much"). For the FACT-HEP V4, QSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

    1. FAC01514 may be rated on a 5-point scale or the subject may prefer not to answer. When the checkbox is marked that the subject prefers not to rate the item, this is noted with QSSTAT = "NOT DONE" and QSREASND = "PREFER NOT TO ANSWER". QSORRES, QSSTRESC, and QSSTRESN are all missing.

  2. The time period of evaluation for the FACT-HEP V4 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the FACT-HEP V4 is the past 7 days (QSEVLINT = "-P7D").

  3. Items are divided into 5 subcategories represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", "FUNCTIONAL WELL-BEING", and "ADDITIONAL CONCERNS".

  4. Records are created in qs.xpt for every item on the instrument: 

    1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE".  If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "LOGICALLY SKIPPED ITEM" or QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

  5. The FACT-HEP V4 instrument includes subscale scores for each subcategory in addition to trial outcome index, FACT-G, and total scores per FACIT.org's scoring materials and are considered as captured data on the CRF and are not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from FACIT.org.

    1. Subscores and total scores are represented in QSORRES.

    2. If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.
  6. Terminology

    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the QRS FACT-HEP V4 QS Domain Model

The FACT-HEP V4 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the FACT-HEP V4 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.

...

Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.

For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:

...

When the reason is collected for a not done visit, information or a row description should be added as follows:

  • FACIT.org for more information as well as the scoring guide.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the FACT-HEP V4 are listed below.

The FACT-HEP V4 is a multiple-choice health-related quality of life questionnaire about problems associated with hepatobiliary cancer. It consists of 45 items rated on a 5-point scale. The FACT-G is included as the first 27 items in the FACT-HEP V4. 

  1. All items rated on a 5-point scale include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "Not at all", 4 = "Very much"). For the FACT-HEP V4, QSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

    1. FAC01514 may be rated on a 5-point scale or the subject may prefer not to answer. When the checkbox is marked that the subject prefers not to answer the item, this is noted with QSSTAT = "NOT DONE" and QSREASND = "PREFER NOT TO ANSWER". QSORRES, QSSTRESC, and QSSTRESN are all missing.

  2. The time period of evaluation for the FACT-HEP V4 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the FACT-HEP V4 is the past 7 days (QSEVLINT = "-P7D").

  3. Items are divided into 5 subcategories represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", "FUNCTIONAL WELL-BEING", and "ADDITIONAL CONCERNS".

  4. Records are created in qs.xpt for every item on the instrument: 

    1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE".  If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

  5. The FACT-HEP V4 instrument includes subscale scores for each subcategory in addition to trial outcome index, FACT-G, and total scores per FACIT.org's scoring materials and are considered as captured data on the CRF and are not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from FACIT.org.

    1. Subscores and total scores are represented in QSORRES.

    2. If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.
  6. Terminology

    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the QRS FACT-HEP V4 QS Domain Model

The FACT-HEP V4 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the FACT-HEP V4 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.


Info

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.


The following table represents the items from the FACT-HEP V4 instrument. The subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, and no date is assumed for when the visit would have occurred.

Dataset wrap
Nameqs
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011FAC01501FAC015-I Have a Lack of EnergyFACT-HEP V4PHYSICAL WELL-BEINGA little bit11

Y12015-05-15-P7D
2STUDYXQS2324-P00012FAC01502FAC015-I Have NauseaFACT-HEP V4PHYSICAL WELL-BEINGNot at all00

Y12015-05-15-P7D
3STUDYXQS2324-P00013FAC01503FAC015-Trouble Meeting Needs of FamilyFACT-HEP V4PHYSICAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
4STUDYXQS2324-P00014FAC01504FAC015-I Have PainFACT-HEP V4PHYSICAL WELL-BEINGA little bit11

...

Info

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

...

I do not wake up at night
Dataset wrap
Nameqs
0
Rowcaps
Rows 13-14:Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX".
Rows 15-16:Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX".
Row 33:The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF.
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011IDSR101IDSR1-Falling AsleepIDS-SRI never take longer than 30 minutes to fall asleep0


Y12015-05-15-P7D
2
5STUDYXQS2324-P00015
2IDSR102IDSR1-Sleep During the NightIDS-SR
FAC01505FAC015-Botheredby Treatment Side EffectFACT-HEP V4PHYSICAL WELL-BEINGNot at all00

Y12015-05-15-P7D
3
6STUDYXQS2324-P0001
3IDSR103IDSR1-Waking Up Too EarlyIDS-SRMost of the time, I awaken no more than 30 minutes before I need to get up0
6FAC01506FAC015-I Feel IllFACT-HEP V4PHYSICAL WELL-BEINGA little bit11
0


Y12015-05-15-P7D
4
7STUDYXQS2324-P0001
4
7
IDSR104
FAC01507
IDSR1-Sleeping Too MuchIDS-SRI sleep no longer than 7-8 hours/night, without napping during the day0
FAC015-I Am Forced to Spend Time in BedFACT-HEP V4PHYSICAL WELL-BEINGA little bit11
0


Y12015-05-15-P7D
5
8STUDYXQS2324-P00018
5IDSR105IDSR1-Feeling SadIDS-SRI feel sad less than half the time1
FAC01508FAC015-I Feel Close to My FriendsFACT-HEP V4SOCIAL/FAMILY WELL-BEINGQuite a bit33
1


Y12015-05-15-P7D
6
9STUDYXQS2324-P0001
6
9
IDSR106IDSR1- Feeling IrritableIDS-SRI feel irritable less than half the time1
FAC01509FAC015-Get Emotional Support From FamilyFACT-HEP V4SOCIAL/FAMILY WELL-BEINGQuite a bit33
1


Y12015-05-15-P7D
7
10STUDYXQS2324-P0001
7
10
IDSR107
FAC01510
IDSR1-Feeling Anxious or TenseIDS-SRI feel anxious (tense) less than half the time1
FAC015-I Get Support From FriendsFACT-HEP V4SOCIAL/FAMILY WELL-BEINGSomewhat22
1


Y12015-05-15-P7D
8
11STUDYXQS2324-P0001
8IDSR108IDSR1-Your Mood to Good/Desired EventsIDS-SRMy mood brightens but I do not feel like my normal self when good events occur1
11FAC01511FAC015-My Family Has Accepted My IllnessFACT-HEP V4SOCIAL/FAMILY WELL-BEINGQuite a bit33
1


Y12015-05-15-P7D
9
12STUDYXQS2324-P0001
9
12
IDSR109
FAC01512
IDSR1-Mood in Relation to Time of DayIDS-SRMy mood often relates to the time of day because of environmental events (e.g., being alone, working)1
FAC015-Satisfied Communication IllnessFACT-HEP V4SOCIAL/FAMILY WELL-BEINGVery much44
1


Y12015-05-15-P7D
10
13STUDYXQS2324-P0001
10
13
IDSR109A
FAC01513
IDSR1-Mood Worse Morn/Afternoon/NightIDS-SRAfternoon
FAC015-I Feel close to My PartnerFACT-HEP V4SOCIAL/FAMILY WELL-BEINGVery much44
Afternoon33


Y12015-05-15-P7D
Rows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.)
14STUDYXQS2324-P0001
33
14
IDSR131
FAC01514
IDSR1-ScoreIDS-SR1818
FAC015-I Am Satisfied With My Sex LifeFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONEPREFER NOT TO ANSWER
18
Y12015-05-15
Info

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

Dataset wrap
Namesuppqs
STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGSTUDYXQSP0001QSSEQSequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8)Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).Label for QNAM (e.g., Contact Type)Value of QNAM variable ( e.g., SUBJECT VISIT)CRF

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

Info

Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.

If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.

Some example mappings are below.

...

For QRS instruments with subcategories:

When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, items on the QRS Short_Name are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

...

Info
titleFor public domain instrument's published QRS responses

  • If this is a public domain instrument that has an individual item with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.

    • The controlled response terminology for the tests below is named --TESTCDOR for the variable RSORRES and --TESTCDSTR for the variables RSSTRESN and RSSTTRESC.

  • If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.
    • The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.

...

If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

"All QSTESTCDs"

...

Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

Info
titleFor public domain instrument's published QRS responses

If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses. This approach used the CDISC QRS CT instrument's SYNONYM as part of the codelist name.

The controlled response terminology for the tests below is named SYNONYMSET1OR for the variable RSORRES and SYNONYMSET1STR for the variables RSSTRESN and RSSTTRESC.

...

If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

QSTESTCD = "test code 1" QSTEST = "test name 1"

QSTESTCD = "test code 4" QSTEST = "test name 4"

QSTESTCD = "test code 5" QSTEST = "test name 5"

QSTESTCD = "test code 6" QSTEST = "test name 6"

QSTESTCD = "test code 7" QSTEST = "test name 7"

QSTESTCD = "test code 8" QSTEST = "test name 8"

QSTESTCD = "test code 15" QSTEST = "test name 15"

QSTESTCD = "test code 22" QSTEST = "test name 22"

QSTESTCD = "test code 27" QSTEST = "test name 27"

QSTESTCD = "test code 29" QSTEST = "test name 29"

-P7D
15STUDYXQS2324-P000115FAC01515FAC015-I Feel SadFACT-HEP V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
16STUDYXQS2324-P000116FAC01516FAC015-Satisfied With How I Am CopingFACT-HEP V4EMOTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
17STUDYXQS2324-P000117FAC01517FAC015-Losing Hope Against IllnessFACT-HEP V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
18STUDYXQS2324-P000118FAC01518FAC015-I Feel NervousFACT-HEP V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
19STUDYXQS2324-P000119FAC01519FAC015-I Worry About DyingFACT-HEP V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
20STUDYXQS2324-P000120FAC01520FAC015-Worry My Condition Will Get WorseFACT-HEP V4EMOTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
21STUDYXQS2324-P000121FAC01521FAC015-I Am Able to WorkFACT-HEP V4FUNCTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
22STUDYXQS2324-P000122FAC01522FAC015-My Work Is FulfillingFACT-HEP V4FUNCTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
23STUDYXQS2324-P000123FAC01523FAC015-I Am Able to Enjoy LifeFACT-HEP V4FUNCTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
24STUDYXQS2324-P000124FAC01524FAC015-I Have Accepted My IllnessFACT-HEP V4FUNCTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
25STUDYXQS2324-P000125FAC01525FAC015-I Am Sleeping WellFACT-HEP V4FUNCTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
26STUDYXQS2324-P000126FAC01526FAC015-Enjoy Things I Usually Do for FunFACT-HEP V4FUNCTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
27STUDYXQS2324-P000127FAC01527FAC015-Content With Quality of My LifeFACT-HEP V4FUNCTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
28STUDYXQS2324-P000128FAC01528FAC015-Swelling/Cramps in Stomach AreaFACT-HEP V4ADDITIONAL CONCERNSSomewhat22

Y12015-05-15-P7D
29STUDYXQS2324-P000129FAC01529FAC015-I Am Losing WeightFACT-HEP V4ADDITIONAL CONCERNSNot at all00

Y12015-05-15-P7D
30STUDYXQS2324-P000130FAC01530FAC015-I Have Control of My BowelsFACT-HEP V4ADDITIONAL CONCERNSQuite a bit33

Y12015-05-15-P7D
31STUDYXQS2324-P000131FAC01531FAC015-I Can Digest My Food WellFACT-HEP V4ADDITIONAL CONCERNSQuite a bit33

Y12015-05-15-P7D
32STUDYXQS2324-P000132FAC01532FAC015-I Have DiarrheaFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
33STUDYXQS2324-P000133FAC01533FAC015-I Have a Good AppetiteFACT-HEP V4ADDITIONAL CONCERNSQuite a bit33

Y12015-05-15-P7D
34STUDYXQS2324-P000134FAC01534FAC015-Unhappy About Change in My AppearFACT-HEP V4ADDITIONAL CONCERNSNot at all00

Y12015-05-15-P7D
35STUDYXQS2324-P000135FAC01535FAC015-I Have Pain in My BackFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
36STUDYXQS2324-P000136FAC01536FAC015-I Am Bothered by ConstipationFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
37STUDYXQS2324-P000137FAC01537FAC015-I Feel FatiguedFACT-HEP V4ADDITIONAL CONCERNSSomewhat22

Y12015-05-15-P7D
38STUDYXQS2324-P000138FAC01538FAC015-Able to Do My Usual ActivitiesFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
39STUDYXQS2324-P000139FAC01539FAC015-Bothered by Jaundice/Yellow SkinFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
40STUDYXQS2324-P000140FAC01540FAC015-I Have Had FeversFACT-HEP V4ADDITIONAL CONCERNSNot at all00

Y12015-05-15-P7D
41STUDYXQS2324-P000141FAC01541FAC015-I Have Had ItchingFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
42STUDYXQS2324-P000142FAC01542FAC015-Had Change in the Way Food TastesFACT-HEP V4ADDITIONAL CONCERNSNot at all00

Y12015-05-15-P7D
43STUDYXQS2324-P000143FAC01543FAC015-I Have Had ChillsFACT-HEP V4ADDITIONAL CONCERNSNot at all00

Y12015-05-15-P7D
44STUDYXQS2324-P000144FAC01544FAC015-My Mouth Is DryFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
45STUDYXQS2324-P000145FAC01545FAC015-Discomfort/Pain in Stomach AreaFACT-HEP V4ADDITIONAL CONCERNSSomewhat22

Y12015-05-15-P7D
46STUDYXQS2324-P000146FAC01546FAC015-Physical Subscale ScoreFACT-HEP V4
222222

Y12015-05-15-P7D
47STUDYXQS2324-P000147FAC01547FAC015-Social/Family Subscale ScoreFACT-HEP V4
222222

Y12015-05-15-P7D
48STUDYXQS2324-P000148FAC01548FAC015-Emotional Subscale ScoreFACT-HEP V4
171717

Y12015-05-15-P7D
49STUDYXQS2324-P000149FAC01549FAC015-Functional Subscale ScoreFACT-HEP V4
161616

Y12015-05-15-P7D
50STUDYXQS2324-P000150FAC01550FAC015-Additional Concern Subscale ScoreFACT-HEP V4
545454

Y12015-05-15-P7D
51STUDYXQS2324-P000151FAC01551FAC015-Trial Outcome Index ScoreFACT-HEP V4
929292

Y12015-05-15-P7D
52STUDYXQS2324-P000152FAC01552FAC015-FACT-G Total ScoreFACT-HEP V4
777777

Y12015-05-15-P7D
53STUDYXQS2324-P000153FAC01553FAC015-Total ScoreFACT-HEP V4
131131131

Y12015-05-15-P7D
54STUDYXQS2324-P00011FAC01501FAC015-I Have a Lack of EnergyFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

55STUDYXQS2324-P00012FAC01502FAC015-I Have NauseaFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

56STUDYXQS2324-P00013FAC01503FAC015-Trouble Meeting Needs of FamilyFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

57STUDYXQS2324-P00014FAC01504FAC015-I Have PainFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

58STUDYXQS2324-P00015FAC01505FAC015-Botheredby Treatment Side EffectFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

59STUDYXQS2324-P00016FAC01506FAC015-I Feel IllFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

60STUDYXQS2324-P00017FAC01507FAC015-I Am Forced to Spend Time in BedFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

61STUDYXQS2324-P00018FAC01508FAC015-I Feel Close to My FriendsFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

62STUDYXQS2324-P00019FAC01509FAC015-Get Emotional Support From FamilyFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

63STUDYXQS2324-P000110FAC01510FAC015-I Get Support From FriendsFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

64STUDYXQS2324-P000111FAC01511FAC015-My Family Has Accepted My IllnessFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

65STUDYXQS2324-P000112FAC01512FAC015-Satisfied Communication IllnessFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

66STUDYXQS2324-P000113FAC01513FAC015-I Feel close to My PartnerFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

67STUDYXQS2324-P000114FAC01514FAC015-I Am Satisfied With My Sex LifeFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

68STUDYXQS2324-P000115FAC01515FAC015-I Feel SadFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

69STUDYXQS2324-P000116FAC01516FAC015-Satisfied With How I Am CopingFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

70STUDYXQS2324-P000117FAC01517FAC015-Losing Hope Against IllnessFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

71STUDYXQS2324-P000118FAC01518FAC015-I Feel NervousFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

72STUDYXQS2324-P000119FAC01519FAC015-I Worry About DyingFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

73STUDYXQS2324-P000120FAC01520FAC015-Worry My Condition Will Get WorseFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

74STUDYXQS2324-P000121FAC01521FAC015-I Am Able to WorkFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

75STUDYXQS2324-P000122FAC01522FAC015-My Work Is FulfillingFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

76STUDYXQS2324-P000123FAC01523FAC015-I Am Able to Enjoy LifeFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

77STUDYXQS2324-P000124FAC01524FAC015-I Have Accepted My IllnessFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

78STUDYXQS2324-P000125FAC01525FAC015-I Am Sleeping WellFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

79STUDYXQS2324-P000126FAC01526FAC015-Enjoy Things I Usually Do for FunFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

80STUDYXQS2324-P000127FAC01527FAC015-Content With Quality of My LifeFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

81STUDYXQS2324-P000128FAC01528FAC015-Swelling/Cramps in Stomach AreaFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

82STUDYXQS2324-P000129FAC01529FAC015-I Am Losing WeightFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

83STUDYXQS2324-P000130FAC01530FAC015-I Have Control of My BowelsFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

84STUDYXQS2324-P000131FAC01531FAC015-I Can Digest My Food WellFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

85STUDYXQS2324-P000132FAC01532FAC015-I Have DiarrheaFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

86STUDYXQS2324-P000133FAC01533FAC015-I Have a Good AppetiteFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

87STUDYXQS2324-P000134FAC01534FAC015-Unhappy About Change in My AppearFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

88STUDYXQS2324-P000135FAC01535FAC015-I Have Pain in My BackFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

89STUDYXQS2324-P000136FAC01536FAC015-I Am Bothered by ConstipationFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

90STUDYXQS2324-P000137FAC01537FAC015-I Feel FatiguedFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

91STUDYXQS2324-P000138FAC01538FAC015-Able to Do My Usual ActivitiesFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

92STUDYXQS2324-P000139FAC01539FAC015-Bothered by Jaundice/Yellow SkinFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

93STUDYXQS2324-P000140FAC01540FAC015-I Have Had FeversFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

94STUDYXQS2324-P000141FAC01541FAC015-I Have Had ItchingFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

95STUDYXQS2324-P000142FAC01542FAC015-Had Change in the Way Food TastesFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

96STUDYXQS2324-P000143FAC01543FAC015-I Have Had ChillsFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

97STUDYXQS2324-P000144FAC01544FAC015-My Mouth Is DryFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

98STUDYXQS2324-P000145FAC01545FAC015-Discomfort/Pain in Stomach AreaFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

99STUDYXQS2324-P000146FAC01546FAC015-Physical Subscale ScoreFACT-HEP V4



NOT DONE

2

100STUDYXQS2324-P000147FAC01547FAC015-Social/Family Subscale ScoreFACT-HEP V4



NOT DONE

2

101STUDYXQS2324-P000148FAC01548FAC015-Emotional Subscale ScoreFACT-HEP V4



NOT DONE

2

102STUDYXQS2324-P000149FAC01549FAC015-Functional Subscale ScoreFACT-HEP V4



NOT DONE

2

103STUDYXQS2324-P000150FAC01550FAC015-Additional Concern Subscale ScoreFACT-HEP V4



NOT DONE

2

104STUDYXQS2324-P000151FAC01551FAC015-Trial Outcome Index ScoreFACT-HEP V4



NOT DONE

2

105STUDYXQS2324-P000152FAC01552FAC015-FACT-G Total ScoreFACT-HEP V4



NOT DONE

2

106STUDYXQS2324-P000153FAC01553FAC015-Total ScoreFACT-HEP V4



NOT DONE

2


4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1, Assumptions, items on the FACT-HEP V4 are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

QSSCATQSTESTCD
PHYSICAL WELL-BEINGFAC01501 - FAC01507
SOCIAL/FAMILY WELL-BEINGFAC01508 - FAC01514
EMOTIONAL WELL-BEINGFAC01515 - FAC01520
FUNCTIONAL WELL-BEINGFAC01521 - FAC01527
ADDITIONAL CONCERNSFAC01528 - FAC01545


All QSTESTCDs

QSORRES

QSSTRESC

QSSTRESN

Not at all00
A little bit11
Somewhat22
Quite a bit33
Very much44

...

Omit the QSSTRESN column when it is not applicable to the dataset.

QSTESTCD = "test code" QSTEST = "test name"

...

Info
titleFor public domain instrument's published QRS responses

If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.

    • The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.

...

For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:

QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through

QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"

...

5 Supplemental Qualifier Name Codes

Info

The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

Remove Section 5 if it does not apply to the new instrument.

The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

...

Namesuppqs

...





End of Document