...
The original scores include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "None"). For the MTWS-R, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
The time period of evaluation for the MTWS-R is populated in the QSEVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the MTWS-R is typically the last 24 hours (QSEVLINT = "-P24HPT24H").
Records are created in qs.xpt for every instrument item:
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.
- Due to the variability of copyright holder and public domain derived subscore and overall score generation processes, records are not included for derived subscores or overall scores that are not provided.
The MTWS-R instrument may include an overall score that is considered as captured data on the instrument and is not considered as derived in the example below. This overall score, or total withdrawal discomfort score, consists of the first eight symptoms. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from [Insert copyright holder's name or other source.].
- Subscores and overall scores are represented in QSORRES, QSSTRESC, and QSSTRESN.
- If subscores or overall scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible. It is the sponsors repsonsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
Terminology
QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN values are included in CDISC Controlled Terminology.
A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-15: | Comprise eight well-validated, primary withdrawal symptom descriptors (single items) based on DSM-5 (“Angry, irritable, frustrated;” “Anxious, nervous;” “Depressed mood, sad;” “Difficulty concentrating;” “Increased appetite, hungry, weight gain;” “Insomnia, sleep problems, awakening at night;” “Restless;” and “Impatient”) as well as nine additional symptom candidates (e.g., “Craving to smoke;” “Decreased pleasure from events;” and “Dizziness”). | | Row 16: | Shows the total withdrawal discomfort score calculated from the first eight symptoms. | | Rows 17-32: | Show the subject was not evaluated on this instrument at visit 2. Since the reason for not completing the visit was collected, the date is included in QSDTC for when the visit was planned. | |
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT | | 1 | STUDYX | QS | 2324-P0001 | 1 | MTWSR101 | MTWSR1-Angry, Irritable, Frustrated | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 2 | STUDYX | QS | 2324-P0001 | 2 | MTWSR102 | MTWSR1-Anxious, Nervous | MTWS-R | Moderate | 3 | 3 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 3 | STUDYX | QS | 2324-P0001 | 3 | MTWSR103 | MTWSR1-Depressed Mood, Sad | MTWS-R | Mild | 2 | 2 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 4 | STUDYX | QS | 2324-P0001 | 4 | MTWSR104 | MTWSR1-Difficulty Concentrating | MTWS-R | Mild | 2 | 2 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 5 | STUDYX | QS | 2324-P0001 | 5 | MTWSR105 | MTWSR1-Inc Appetite, Hungry, Weight Gain | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 6 | STUDYX | QS | 2324-P0001 | 6 | MTWSR106 | MTWSR1-Sleep Problems/Awakening at Night | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 7 | STUDYX | QS | 2324-P0001 | 7 | MTWSR107 | MTWSR1-Restless | MTWS-R | Moderate | 3 | 3 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 8 | STUDYX | QS | 2324-P0001 | 8 | MTWSR108 | MTWSR1-Impatient | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 9 | STUDYX | QS | 2324-P0001 | 9 | MTWSR109 | MTWSR1-Craving to Smoke | MTWS-R | Severe | 4 | 4 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 10 | STUDYX | QS | 2324-P0001 | 10 | MTWSR110 | MTWSR1-Constipation | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 11 | STUDYX | QS | 2324-P0001 | 11 | MTWSR111 | MTWSR1-Dizziness | MTWS-R | None | 0 | 0 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 12 | STUDYX | QS | 2324-P0001 | 12 | MTWSR112 | MTWSR1-Coughing | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 13 | STUDYX | QS | 2324-P0001 | 13 | MTWSR113 | MTWSR1-Dreaming or Nightmares | MTWS-R | Slight | 1 | 1 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 14 | STUDYX | QS | 2324-P0001 | 14 | MTWSR114 | MTWSR1-Nausea | MTWS-R | None | 0 | 0 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 15 | STUDYX | QS | 2324-P0001 | 15 | MTWSR115 | MTWSR1-Sore Throat | MTWS-R | None | 0 | 0 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 16 | STUDYX | QS | 2324-P0001 | 16 | MTWSR116 | MTWSR1-Total Withdrawal Discomfort Score | MTWS-R | 14 | 14 | 14 |
|
| Y | 1 | 2023-08-13 | -P24HPT24H | | 17 | STUDYX | QS | 2324-P0001 | 17 | MTWSR101 | MTWSR1-Angry, Irritable, Frustrated | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10-P24H |
| | 18 | STUDYX | QS | 2324-P0001 | 18 | MTWSR102 | MTWSR1-Anxious, Nervous | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H |
| | 19 | STUDYX | QS | 2324-P0001 | 19 | MTWSR103 | MTWSR1-Depressed Mood, Sad | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10-P24H |
| | 20 | STUDYX | QS | 2324-P0001 | 20 | MTWSR104 | MTWSR1-Difficulty Concentrating | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10-P24H |
| | 21 | STUDYX | QS | 2324-P0001 | 21 | MTWSR105 | MTWSR1-Inc Appetite, Hungry, Weight Gain | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H |
| | 22 | STUDYX | QS | 2324-P0001 | 22 | MTWSR106 | MTWSR1-Sleep Problems/Awakening at Night | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H |
| | 23 | STUDYX | QS | 2324-P0001 | 23 | MTWSR107 | MTWSR1-Restless | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H |
| | 24 | STUDYX | QS | 2324-P0001 | 24 | MTWSR108 | MTWSR1-Impatient | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10-P24H |
| | 25 | STUDYX | QS | 2324-P0001 | 25 | MTWSR109 | MTWSR1-Craving to Smoke | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H |
| | 26 | STUDYX | QS | 2324-P0001 | 26 | MTWSR110 | MTWSR1-Constipation | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H |
| | 27 | STUDYX | QS | 2324-P0001 | 27 | MTWSR111 | MTWSR1-Dizziness | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10-P24H |
| | 28 | STUDYX | QS | 2324-P0001 | 28 | MTWSR112 | MTWSR1-Coughing | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H |
| | 29 | STUDYX | QS | 2324-P0001 | 29 | MTWSR113 | MTWSR1-Dreaming or Nightmares | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10-P24H |
| | 30 | STUDYX | QS | 2324-P0001 | 30 | MTWSR114 | MTWSR1-Nausea | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10 | -P24H |
| | 31 | STUDYX | QS | 2324-P0001 | 31 | MTWSR115 | MTWSR1-Sore Throat | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10-P24H |
| | 32 | STUDYX | QS | 2324-P0001 | 32 | MTWSR116 | MTWSR1-Total Withdrawal Discomfort Score | MTWS-R |
|
|
| NOT DONE | PATIENT MISSED FORM AT VISIT. FILLED OUT ELECTRONICALLY FEW DAYS LATER AS UNSCHEDULED. |
| 2 | 2023-09-10-P24H |
|
|
|
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.
...