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Title | Functional Assessment of Cancer Therapy-Hepatobiliary Version 4 (FACT-HEP V4) |
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CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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QRS Short Name | |
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QRS Permission Status | Approve |
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Team | Pancreatic Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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Supplement Version | 1.0 |
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Status | DRAFT |
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Date | 2002-1011-28 01 |
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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.
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Revision History
Date | Version |
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2022-1011-2801 | 1.0 Draft |
© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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- 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.
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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")
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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.
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.
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.
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.
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").
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".
Records are created in qs.xpt for every item on the instrument:
For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then
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.
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.
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").
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".
Records are created in qs.xpt for every item on the instrument:
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.
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.
Subscores and total scores are represented in QSORRES.
- If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.
- Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.
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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.with items 13 and 14 that differ from the remaining items on the CRF. | |
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Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
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1 | STUDYX | QS | 2324-P0001 | 1 | FAC01501 | FAC015-I Have a Lack of Energy | FACT-HEP V4 |
| 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | 2 | STUDYX | QS | 2324-P0001 | 2 | FAC01502 | FAC015-I Have Nausea | FACT-HEP V4 |
| 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | 3 | STUDYX | QS | 2324-P0001 | 3 | FAC01503 | FAC015-Trouble Meeting Needs of Family | FACT-HEP V4 |
| 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | 4 | STUDYX | QS | 2324-P0001 | 4 | FAC01504 | FAC015-I Have Pain | FACT-HEP V4 |
| 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | 5 | STUDYX | QS | 2324-P0001 | 5 | FAC01505 | FAC015-Botheredby Treatment Side Effect | FACT-HEP V4 |
| 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 6 | STUDYX | QS | 2324-P0001 | 6 | FAC01506 | FAC015-I Feel Ill | FACT-HEP V4 |
| 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 7 | STUDYX | QS | 2324-P0001 | 7 | FAC01507 | FAC015-I Am Forced to Spend Time in Bed | FACT-HEP V4 |
| 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 8 | STUDYX | QS | 2324-P0001 | 8 | FAC01508 | FAC015-I Feel Close to My Friends | FACT-HEP V4 |
| 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 9 | STUDYX | QS | 2324-P0001 | 9 | FAC01509 | FAC015-Get Emotional Support From Family | FACT-HEP V4 |
| 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015-I Get Support From Friends | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 11 | STUDYX | QS | 2324-P0001 | 11 | FAC01511 | FAC015-My Family Has Accepted My Illness | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 12 | STUDYX | QS | 2324-P0001 | 12 | FAC01512 | FAC015-Satisfied Communication Illness | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 13 | STUDYX | QS | 2324-P0001 | 13 | FAC01513 | FAC015-I Feel close to My Partner | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 14 | STUDYX | QS | 2324-P0001 | 14 | FAC01514 | FAC015-I Am Satisfied With My Sex Life | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 15 | STUDYX | QS | 2324-P0001 | 15 | FAC01515 | FAC015-I Feel Sad | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 16 | STUDYX | QS | 2324-P0001 | 16 | FAC01516 | FAC015-Satisfied With How I Am Coping | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 17 | STUDYX | QS | 2324-P0001 | 17 | FAC01517 | FAC015-Losing Hope Against Illness | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 18 | STUDYX | QS | 2324-P0001 | 18 | FAC01518 | FAC015-I Feel Nervous | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 19 |
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Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
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1 | STUDYX | QS | 2324-P0001 | 119 | FAC01501FAC01519 | FAC015-I Have a Lack of EnergyWorry About Dying | FACT-HEP V40 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | 220 | STUDYX | QS | 2324-P0001 | 220 | FAC01502FAC01520 | FAC015-I Have NauseaWorry My Condition Will Get Worse | FACT-HEP V4 | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | 321 | STUDYX | QS | 2324-P0001 | 321 | FAC01503FAC01521 | FAC015-Trouble Meeting Needs of FamilyI Am Able to Work | FACT-HEP V40 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | 422 | STUDYX | QS | 2324-P0001 | 422 | FAC01504FAC01522 | FAC015-I Have PainMy Work Is Fulfilling | FACT-HEP V4 | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | 523 | STUDYX | QS | 2324-P0001 | 523 | FAC01505FAC01523 | FAC015-Botheredby Treatment Side EffectI Am Able to Enjoy Life | FACT-HEP V4 | 1 | 1V4 |
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| Y | 1 | 2015-05-15 | -P7D | 624 | STUDYX | QS | 2324-P0001 | 624 | FAC01506FAC01524 | FAC015-I Feel IllHave Accepted My Illness | FACT-HEP V41 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 725 | STUDYX | QS | 2324-P0001 | 725 | FAC01507FAC01525 | FAC015-I Am Forced to Spend Time in BedSleeping Well | FACT-HEP V4 | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 826 | STUDYX | QS | 2324-P0001 | 826 | FAC01508FAC01526 | FAC015-I Feel Close to My FriendsEnjoy Things I Usually Do for Fun | FACT-HEP V41 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 927 | STUDYX | QS | 2324-P0001 | 927 | FAC01509FAC01527 | FAC015-Get Emotional Support From FamilyContent With Quality of My Life | FACT-HEP V4 | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 1028 | STUDYX | QS | 2324-P0001 | 1028 | FAC01510FAC01528 | FAC015-I Get Support From FriendsSwelling/Cramps in Stomach Area | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 1129 | STUDYX | QS | 2324-P0001 | 1129 | FAC01511FAC01529 | FAC015-My Family Has Accepted My IllnessI Am Losing Weight | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 1230 | STUDYX | QS | 2324-P0001 | 1230 | FAC01512FAC01530 | FAC015-Satisfied Communication IllnessI Have Control of My Bowels | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 1331 | STUDYX | QS | 2324-P0001 | 1331 | FAC01513FAC01531 | FAC015-I Feel close to My PartnerCan Digest My Food Well | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 1432 | STUDYX | QS | 2324-P0001 | 1432 | FAC01514FAC01532 | FAC015-I Am Satisfied With My Sex LifeHave Diarrhea | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 1533 | STUDYX | QS | 2324-P0001 | 1533 | FAC01515FAC01533 | FAC015-I Feel SadHave a Good Appetite | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 1634 | STUDYX | QS | 2324-P0001 | 1634 | FAC01516FAC01534 | FAC015-Satisfied With How I Am CopingUnhappy About Change in My Appear | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 1735 | STUDYX | QS | 2324-P0001 | 1735 | FAC01517FAC01535 | FAC015-Losing Hope Against IllnessI Have Pain in My Back | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 1836 | STUDYX | QS | 2324-P0001 | 1836 | FAC01518FAC01536 | FAC015-I Feel NervousAm Bothered by Constipation | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 1937 | STUDYX | QS | 2324-P0001 | 1937 | FAC01519FAC01537 | FAC015-I Feel Fatigued | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 2038 | STUDYX | QS | 2324-P0001 | 2038 | FAC01520FAC01538 | FAC015-Able to Do My Usual Activities | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 2139 | STUDYX | QS | 2324-P0001 | 2139 | FAC01521FAC01539 | FAC015-Bothered by Jaundice/Yellow Skin | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 2240 | STUDYX | QS | 2324-P0001 | 2240 | FAC01522FAC01540 | FAC015-I Have Had Fevers | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 2341 | STUDYX | QS | 2324-P0001 | 2341 | FAC01523FAC01541 | FAC015-I Have Had Itching | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 2442 | STUDYX | QS | 2324-P0001 | 2442 | FAC01524FAC01542 | FAC015-Had Change in the Way Food Tastes | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 2543 | STUDYX | QS | 2324-P0001 | 2543 | FAC01525FAC01543 | FAC015-I Have Had Chills | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 2644 | STUDYX | QS | 2324-P0001 | 2644 | FAC01526FAC01544 | FAC015-My Mouth Is Dry | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | 2745 | STUDYX | QS | 2324-P0001 | 2745 | FAC01527FAC01545 | FAC015-Discomfort/Pain in Stomach Area | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D |
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