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Revision History

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

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This document describes the CDISC implementation of the Functional Assessment of Cancer Therapy-Hepatobiliary instrumentGeneral 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.

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David Cella, PhD. owns the copyright for the FACT-HEP G 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.

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

Reference for the FACT-HEP G 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.

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

The FACT-HEP G V4 is a multiple-choice health-related general quality of life questionnaire about problems associated with hepatobiliary cancer. It consists of 45 27 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 G 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 FAC00114 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 G 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 G 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 G V4 instrument includes subscale scores for each subcategory in addition to trial outcome index, FACT-G, and total scores a total score 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-

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G V4 QS Domain Model

The FACT-HEP V4 G 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 G 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.

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The table represents the items from the FACT-HEP G 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, no date is assumed for when the visit would have occurred.

4 SDTM Mapping Strategy

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As stated in Section 3.1 assumptions, items on the FACT-HEP G 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.

All QSTESTCDs

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