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This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS RS domain. It also provides guidance on how the result variables (QSORRESRSORRES, QSSTRESCRSSTRESC, and QSSTRESNRSSTRESN) should be populated.
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Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included. If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement. Some example mappings are below. |
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For QRS instruments with subcategories:
When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.
QSSCAT alignment with QSTESTCD
As stated in Section 3.1 assumptions, items on the HAMD 17 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.
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If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:
"All QSTESTCDs"
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Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.
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If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:
QSTESTCD = "test code 1" QSTEST = "test name 1"
QSTESTCD = "test code 4" QSTEST = "test name 4"
QSTESTCD = "test code 5" QSTEST = "test name 5"
QSTESTCD = "test code 6" QSTEST = "test name 6"
QSTESTCD = "test code 7" QSTEST = "test name 7"
QSTESTCD = "test code 8" QSTEST = "test name 8"
QSTESTCD = "test code 15" QSTEST = "test name 15"
QSTESTCD = "test code 22" QSTEST = "test name 22"
QSTESTCD = "test code 27" QSTEST = "test name 27"
QSTESTCD = "test code 29" QSTEST = "test name 29"
RSTESTCD = "HAMD101" RSTEST = "HAMD1-Depressed Mood"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Absent. | 0 | 0 |
| These feeling states indicated only on questioning. | 1 | 1 |
| These feeling states spontaneously reported verbally. | 2 | 2 |
| Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep. | 3 | 3 |
| Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication. | 4 | 4 |
RSTESTCD = "HAMD102" RSTEST = "HAMD1-Feelings of Guilt"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Absent. | 0 | 0 |
| Self reproach, feels he/she has let people down. | 1 | 1 |
| Ideas of guilt or rumination over past errors or sinful deeds. | 2 | 2 |
| Present illness is a punishment. Delusions of guilt. | 3 | 3 |
| Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations. | 4 | 4 |
RSTESTCD = "HAMD103" RSTEST = "HAMD1-Suicide"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Absent. | 0 | 0 |
| Feels life is not worth living. | 1 | 1 |
| Wishes he/she were dead or any thoughts of possible death to self. | 2 | 2 |
| Ideas or gestures of suicide. | 3 | 3 |
| Attempts at suicide (any serious attempt rates 4). | 4 | 4 |
RSTESTCD = "HAMD104" RSTEST = "HAMD1-Insomnia Early - Early Night"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| No difficulty falling asleep. | 0 | 0 |
| Complains of occasional difficulty falling asleep, i.e. more than ½ hour. | 1 | 1 |
| Complains of nightly difficulty falling asleep. | 2 | 2 |
RSTESTCD = "HAMD105" RSTEST = "HAMD1-Insomnia Middle - Middle Night"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| No difficulty. | 0 | 0 |
| Patient complains of being restless and disturbed during the night. | 1 | 1 |
| Waking during the night – any getting out of bed rates 2 (except for purposes of voiding). | 2 | 2 |
RSTESTCD = "HAMD106" RSTEST = "HAMD1-Insomnia Early Hours - Morning"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| No difficulty. | 0 | 0 |
| Waking in early hours of the morning but goes back to sleep. | 1 | 1 |
| Unable to fall asleep again if he/she gets out of bed. | 2 | 2 |
RSTESTCD = "HAMD107" RSTEST = "HAMD1-Work and Activities"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| No difficulty. | 0 | 0 |
| Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies. | 1 | 1 |
| Loss of interest in activity, hobbies or work – either directly reported by patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities). | 2 | 2 |
| Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores. | 3 | 3 |
| Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted. | 4 | 4 |
RSTESTCD = "HAMD108" RSTEST = "HAMD1-Retardation"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Normal speech and thought. | 0 | 0 |
| Slight retardation during the interview. | 1 | 1 |
| Obvious retardation during the interview. | 2 | 2 |
| Interview difficult. | 3 | 3 |
| Complete stupor. | 4 | 4 |
RSTESTCD = "HAMD109" RSTEST = "HAMD1-Agitation"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| None. | 0 | 0 |
| Fidgetiness. | 1 | 1 |
| Playing with hands, hair, etc. | 2 | 2 |
| Moving about, can’t sit still. | 3 | 3 |
| Hand wringing, nail biting, hair-pulling, biting of lips. | 4 | 4 |
RSTESTCD = "HAMD110" RSTEST = "HAMD1-Anxiety Psychic"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| No difficulty. | 0 | 0 |
| Subjective tension and irritability. | 1 | 1 |
| Worrying about minor matters. | 2 | 2 |
| Apprehensive attitude apparent in face or speech. | 3 | 3 |
| Fears expressed without questioning. | 4 | 4 |
RSTESTCD = "HAMD111" RSTEST = "HAMD1-Anxiety Somatic"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Absent. | 0 | 0 |
| Mild. | 1 | 1 |
| Moderate. | 2 | 2 |
| Severe. | 3 | 3 |
| Incapacitating. | 4 | 4 |
RSTESTCD = "HAMD112" RSTEST = "HAMD1-Somatic Symptoms GI"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| None. | 0 | 0 |
| Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen. | 1 | 1 |
| Difficulty eating without staff urging. Requests or requires laxatives or medications for bowels or medication for gastro-intestinal symptoms. | 2 | 2 |
RSTESTCD = "HAMD113" RSTEST = "HAMD1-General Somatic Symptoms"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| None. | 0 | 0 |
| Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability. | 1 | 1 |
| Any clear-cut symptom rates 2. | 2 | 2 |
RSTESTCD = "HAMD114" RSTEST = "HAMD1-Genital Symptoms"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Absent. | 0 | 0 |
| Mild. | 1 | 1 |
| Severe. | 2 | 2 |
RSTESTCD = "HAMD115" RSTEST = "HAMD1-Hypochondriasis"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Not present. | 0 | 0 |
| Self-absorption (bodily). | 1 | 1 |
| Preoccupation with health. | 2 | 2 |
| Frequent complaints, requests for help, etc. | 3 | 3 |
| Hypochondriacal delusions. | 4 | 4 |
RSTESTCD = "HAMD116A" RSTEST = "HAMD1-Loss of WT According to Patient"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| No weight loss. | 0 | 0 |
| Probable weight loss associated with present illness. | 1 | 1 |
| Definite (according to patient) weight loss. | 2 | 2 |
| Not assessed. | 3 | 3 |
RSTESTCD = "HAMD116B" RSTEST = "HAMD1-Loss of WT According to WK Meas"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Less than 1 lb weight loss in week. | 0 | 0 |
| Greater than 1 lb weight loss in week. | 1 | 1 |
| Greater than 2 lb weight loss in week. | 2 | 2 |
| Not assessed. | 3 | 3 |
RSTESTCD = "HAMD117" RSTEST = "HAMD1-Insight"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Acknowledges being depressed and ill. | 0 | 0 |
| Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc. | 1 | 1 |
| Denies being ill at all. | 2 | 2 |
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Omit the QSSTRESN column when it is not applicable to the dataset.
QSTESTCD = "test code" QSTEST = "test name"
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For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:
QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through
QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"
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5 Supplemental Qualifier Name Codes
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The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black. Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed. Remove Section 5 if it does not apply to the new instrument. |
The following table contains additional standard name codes for use in the Supplement Qualifiers for clinical classifications (SUPPQS) special purpose dataset.
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| Name | suppqs |
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End of Document
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