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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 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 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.
3.2 Example for the QRS FACT-HEP V4 QS Domain Model
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The table represents the items from the QRS Short_Name instrument FACT-HEP V4 instrument.
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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. | |
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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 | IDSR101FAC01501 | IDSR1-Falling Asleep | IDS-SR | I never take longer than 30 minutes to fall asleep | 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 | IDSR102FAC01502 | IDSR1-Sleep During the Night | IDS-SR | FAC015-I Have Nausea | FACT-HEP V4I do not wake up at night |
| 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 3 | STUDYX | QS | 2324-P0001 | 3 | IDSR103FAC01503 | IDSR1-Waking Up Too Early | IDS-SR | Most of the time, I awaken no more than 30 minutes before I need to get up | 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 | IDSR104FAC01504 | IDSR1-Sleeping Too Much | IDS-SR | I sleep no longer than 7-8 hours/night, without napping during the day | 0 | 0 | Y | 1 | FAC015-I Have Pain | FACT-HEP V4 |
| 0 | 0 |
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| Y | 1 | 2015-05-2015-05-15 | -P7D | | 5 | STUDYX | QS | 2324-P0001 | 5 | IDSR105FAC01505 | IDSR1-Feeling Sad | IDS-SR | I feel sad less than half the time | 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 | IDSR106FAC01506 | IDSR1- Feeling Irritable | IDS-SR | I feel irritable less than half the time | 1 | 1 | 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 | IDSR107FAC01507 | IDSR1-Feeling Anxious or Tense | IDS-SR | I feel anxious (tense) less than half the time | 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 | IDSR108FAC01508 | IDSR1-Your Mood to Good/Desired Events | IDS-SR | My mood brightens but I do not feel like my normal self when good events occur | 1 | 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 | IDSR109FAC01509 | IDSR1-Mood in Relation to Time of Day | IDS-SR | My mood often relates to the time of day because of environmental events (e.g., being alone, working) | 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 | IDSR109AFAC01510 | FAC015-I Get Support From Friends | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01511 | FAC015-My Family Has Accepted My Illness | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01512 | FAC015-Satisfied Communication Illness | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01513 | FAC015-I Feel close to My Partner | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01514 | FAC015-I Am Satisfied With My Sex Life | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01515 | FAC015-I Feel Sad | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01516 | FAC015-Satisfied With How I Am Coping | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01517 | FAC015-Losing Hope Against Illness | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01518 | FAC015-I Feel Nervous | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01519 | FAC015- | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015- | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015- | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015- | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015- | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015- | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015- | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015- | FACT-HEP V4 | IDSR1-Mood Worse Morn/Afternoon/Night | IDS-SR | Afternoon | Afternoon |
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| Y | 1 | 2015-05-15 | -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.) | 3310 | STUDYX | QS | 2324-P0001 | 3310 | IDSR131FAC01510 | IDSR1FAC015-Score | IDS-SR | 18 | 18 | 18FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D |
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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 |
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| | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| STUDYX | QS | P0001 | QSSEQ | Sequence 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 | |
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