myCSG © |Area: ADaM| Concept: ADQS : Full ADQS - Questionnaire Analysis Dataset | Lesson: L1101 : ADQSEQ5D dataset for a parallel arm study - statschoice-001 |
- Creation of EQ5D-5L Analysis dataset:
- Includes paramcd, paramn, param, parcat1 and parcat1n derivation
- Includes creation of a derived parameter which is moderately complex (CHI - Compostite Health Index)
- Includes baseline flagging and dependent variables creation - ABLFL, BASE, BASEC CHG
- Includes creation of an analysis flag- ANL01FL - to select one record per analysis visit/parameter/subject
- Includes creation of ANL02FL - to identify postbaseline records
- What is EQ5D-5L
- It is a questionnaire that is used to evaluate the quality of life
- It is a descriptive system that comprises five dimensions:
- mobility
- self-care
- usual activities
- pain/discomfort
- anxiety/depression
- Each dimension has 5 levels:
- no problems
- slight problems
- moderate problems
- severe problems
- extreme problems
- The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension.
- The digits for the five dimensions can be combined into a 5-digit number that describes the patient’s health state.
| VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT |
|---|---|---|---|
| STUDYID | Study Identifier | _ | QS.STUDYID |
| USUBJID | Unique Subject Identifier | _ | QS.USUBJID |
| SUBJID | Subject Identifier for the Study | _ | ADSL.SUBJID |
| SITEID | Study Site Identifier | _ | ADSL.SITEID |
| AGE | Age | _ | ADSL.AGE |
| AGEU | Age Units | _ | ADSL.AGEU |
| SEX | Sex | _ | ADSL.SEX |
| RACE | Race | _ | ADSL.RACE |
| QSSEQ | Sequence Number | _ | QS.QSSEQ |
| ADT | Analysis Date | _ | Populate using QS.QSDTC |
| ADY | Analysis Relative Day | _ | Populate using ADSL.TRTSDT and ADQS.ADT. If ADT is on or after treatment start date then populate as the difference between ADT and TRTSDT and add one to the difference. Else if ADT is before TRTSDT then populate as the difference between ADT and TRTSDT. |
| EPOCH | Epoch | _ | QS.EPOCH |
| VISITNUM | Visit Number | _ | QS.VISITNUM |
| VISIT | Visit Name | _ | QS.VISIT |
| AVISIT | Analysis Visit | _ | 1) Populate with QS.VISIT for scheduled visits. Leave null for unscheduled visits. 2) Populate as "Baseline" on baseline records (ADQS.ABLFL="Y"). |
| AVISITN | Analysis Visit (N) | _ | 1) Populate with QS.VISITNUM for scheduled visits. Leave null for unscheduled visits. 2) Populate as 0 on baseline records (ADQS.ABLFL="Y"). |
| PARAM | Parameter | _ | A. For the source records: Set to "Mobility" when QSTEST="MOBILITY" Set to "Self-care" when QSTEST="SELF-CARE" Set to "Usual activities" when QSTEST="USUAL ACTIVITIES" Set to "Pain/discomfort" when QSTEST="PAIN / DISCOMFORT" Set to "Anxiety/depression" when QSTEST="ANXIETY / DEPRESSION" Set to "Your health today" when QSTEST="YOUR HEALTH TODAY" B. Create a new derived parameter 'Composite Health Index' using individual scores |
| PARAMCD | Parameter Code | _ | For the source records: set to QSTESTCD For the derived parameter Set to 'CHI'. |
| PARAMN | Parameter (N) | _ | For the source parameters: Extract the last character from the PARAMCD and convert it to numeric. For the derived parameter, 'Composite Health Index': Set to 7. |
| PARAMTYP | Parameter Type | _ | Set to "DERIVED" on the newly created parameter (PARAMCD=CHI). |
| PARCAT1 | Parameter Category 1 | _ | QS.QSCAT |
| PARCAT1N | Parameter Category 1 (N) | _ | Populate using QS.QSCAT. Populate as 1 when QSCAT="EQ5D-5L". |
| AVAL | Analysis Value | _ | A. For the source records: Set to QSSTRESN For the derived parameter 'Composite Health Index': B1.Create a temporary variable named SCORE by multiplying the the factor provided based on the response for each parameter. Conversion factors for each response of a parameter are as shown below: For PARAMN=1: For AVAL=1, the conversion factor is: 0 For AVAL=2, the conversion factor is: 0.051 For AVAL=3, the conversion factor is: 0.063 For AVAL=4, the conversion factor is: 0.212 For AVAL=5, the conversion factor is: 0.275 For PARAMN=2: For AVAL=1, the conversion factor is: 0 For AVAL=2, the conversion factor is: 0.057 For AVAL=3, the conversion factor is: 0.076 For AVAL=4, the conversion factor is: 0.181 For AVAL=5, the conversion factor is: 0.217 For PARAMN=3: For AVAL=1, the conversion factor is: 0 For AVAL=2, the conversion factor is: 0.051 For AVAL=3, the conversion factor is: 0.067 For AVAL=4, the conversion factor is: 0.174 For AVAL=5, the conversion factor is: 0.190 For PARAMN=4: For AVAL=1, the conversion factor is: 0 For AVAL=2, the conversion factor is: 0.060 For AVAL=3, the conversion factor is: 0.075 For AVAL=4, the conversion factor is: 0.276 For AVAL=5, the conversion factor is: 0.341 For PARAMN=5: For AVAL=1, the conversion factor is: 0 For AVAL=2, the conversion factor is: 0.079 For AVAL=3, the conversion factor is: 0.104 For AVAL=4, the conversion factor is: 0.296 For AVAL=5, the conversion factor is: 0.301 B2. Transpose the SCORE such that the SCORES of all parameters are on a single record at a timepoint B3. When the SCORE is available for all 5 parameters, create AVAL as 1-0.9675*sum(of score of parameters 1 to 5). |
| AVALC | Analysis Value (C) | _ | For the source parameters: Populate with QSSTRESC |
| BASE | Baseline Value | _ | Populate using ADQS.AVAL on the record where ADQS.ABLFL="Y" of each parameter and subject on all records that subject and parameter. |
| BASEC | Baseline Value (C) | _ | Populate using ADQS.AVALC on the record where ADQS.ABLFL="Y" of each parameter and subject on all records that subject and parameter. |
| CHG | Change from Baseline | _ | Populate as the difference between ADQS.AVAL and ADQS.BASE on postbaseline records (ADQS.ANL02FL="Y"). |
| ABLFL | Baseline Record Flag | _ | Populate as "Y" on the latest record with non-missing result on or prior to treatment start date (ADSL.TRTSDT) for each subject and parameter. |
| ANL01FL | Analysis Flag 01 | _ | Populate as "Y" on the latest record within each analysis visit (ADQS.AVISIT) per subject and parameter. |
| ANL02FL | Analysis Flag 02 | _ | Populate as "Y" on postbaseline records (ADQS.ADT>ADSL.TRTSDT). |
| SAFFL | Safety Population Flag | _ | ADSL.SAFFL |
| RANDFL | Randomized Population Flag | _ | ADSL.RANDFL |
| ENRLFL | Enrolled Population Flag | _ | ADSL.ENRLFL |
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