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This OGI example shows the terminology used to implement the instrument in the QS domain. The example shows the data for 1 subject collected at visits 1 and 2 for 3 OGI instruments and uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.
The table below illustrates implementation of represents the items from the OGI instrument dataset qs.
xpt. It represents a given subject’s responses to the global questions posed in the 3 OGI instruments at 2 visits. QSSCAT is populated with the specific underlying construct (e.g., “BACK PAIN”) being evaluated. The values of QSORRES, QSSTRESC, and QSSTRESN are determined by the sponsor and are therefore represented here with values of “X”. Note that for a given construct (e.g., “BACK PAIN”), it is neither required nor typical for all 3 OGI instruments to be administered within the same clinical study. All 3 OGI instruments have been included in the example below for illustrative purposes only. QSMETHOD is used to store the type of scale used.
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This section provides some examples of commonly utilized response option values for each of the 3 OGI instruments (i.e., OGI-S, OGI-C, OGI-I). Please note that these examples are not intended to be prescriptive; they are provided to help clarify some of the concepts and mapping strategies covered in Section 3, The QS Domain Model. The text of the response option selected by a given study subject at a given assessment time point is stored in the SDTM variable QSORRES, and the corresponding numeric score for the selected response option is stored as a numeric value in the SDTM variable QSSTRESN and as a character value in the SDTM variable QSSTRESC. The values of QSORRES, QSSTRESN, and QSSTRESC provided in this section are to be considered as examples only; the actual values of these variables depend on the specific instrument(s) implemented within a given clinical study.
OGI QSTESTCD and QSTEST Controlled Terminology
Instrument | CDISC Controlled Terminology | ||
QSCATQSCAT | QSTESTCDQSTESTCD | QSTESTQSTEST | |
OGI-S | OGI | OGI0101 | OGI01-Severity |
OGI-C | OGI | OGI0102 | OGI01-Change |
OGI-I | OGI | OGI0103 | OGI01-Improvement |
| QSMETHODQSMETHOD |
| VERBAL RATING SCALE 4-POINT |
| VERBAL RATING SCALE 7-POINT |
| LIKERT SCALE 4-POINT |
| LIKERT SCALE 7-POINT |
QSTESTCD=OGI0101 QSTEST=OGI01-Severity QSMETHOD=LIKERT SCALE 7-POINT
QSORRES | QSSTRESC | QSSTRESN |
Normal | 1 | 1 |
Borderline | 2 | 2 |
Mild | 3 | 3 |
Moderate | 4 | 4 |
Marked | 5 | 5 |
Severe | 6 | 6 |
Extreme | 7 | 7 |
QSTESTCD=OGI0101 QSTEST=OGI01-Severity QSMETHOD=LIKERT SCALE 4-POINT
QSORRESQSORRES | QSSTRESCQSSTRESC | QSSTRESN QSSTRESN |
Normal | 1 | 1 |
Mild | 2 | 2 |
Moderate | 3 | 3 |
Severe | 4 | 4 |
QSTESTCD=OGI0102 QSTEST=OGI01-Change QSMETHOD=LIKERT SCALE 7-POINT
QSORRESQSORRES | QSSTRESCQSSTRESC | QSSTRESN QSSTRESN |
Very much improved | 1 | 1 |
Much improved | 2 | 2 |
Minimally improved | 3 | 3 |
No change | 4 | 4 |
Minimally worse | 5 | 5 |
Much worse | 6 | 6 |
Very much worse | 7 | 7 |
QSTESTCD=OGI0102 QSTEST=OGI01-Change QSMETHOD=LIKERT SCALE 7-POINT
QSORRESQSORRES | QSSTRESCQSSTRESC | QSSTRESN QSSTRESN |
Much worse | -3 | -3 |
Moderately worse | -2 | -2 |
A little worse | -1 | -1 |
No change | 0 | 0 |
A little better | 1 | 1 |
Moderately better | 2 | 2 |
Much better | 3 | 3 |
QSTESTCD=OGI0103 QSTEST=OGI01-Improvement QSMETHOD=LIKERT SCALE 7-POINT
QSORRESQSORRES | QSSTRESCQSSTRESC | QSSTRESN QSSTRESN |
No change | 1 | 1 |
Almost the same | 2 | 2 |
A little better | 3 | 3 |
Somewhat better | 4 | 4 |
Moderately better | 5 | 5 |
Much better | 6 | 6 |
A great deal better | 7 | 7 |
End of Document
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