Sub-Domain: Outcomes and End Points
CRF: Quantitative Sensory Testing (QST)
CDE ID | CDE Name | Variable Name | Definition | Short Description | Additional Notes (Question Text) | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guideline) | Sub Domain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | Source | Form Set | Form | Field | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
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C15935 | Exam room temperature measurement | ExamRoomTempMeasr | The exam room temperature at the time of testing | The exam room temperature at the time of testing | Exam room temperature at the time of testing | Numeric Values |
Indicate numeric value of baseline skin temperature recorded in degrees Fahrenheit or Celsius |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C55778 | Imaging inter peri ictal next headache start duration | ImagInterPeriIctNextHeStartDur | The duration of time until the start of the subject's next inter-ictal or peri-ictal headache. | The duration of time until the start of the subject's next inter-ictal or peri-ictal headache. | If inter-ictal or peri-ictal, duration of time until start of next headache (include units) | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2017-05-31 12:23:34.0 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C15912 | Quantitative sensory testing outcome text | QntSnsryTstOutcmeTxt | Definition of the QST outcome(s) chosen | Definition of the QST outcome(s) chosen | Please define the type of outcome(s) chosen above | Alphanumeric |
Provide a definition for each outcome selected in "Outcome" |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism | 255 |
Free-Form Entry |
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C15925 | Quantitative sensory testing examiner count | QntSnsryTstExmnrCt | Number of examiners performing QST throughout the study | Number of examiners performing QST throughout the study | Number of examiners performing QST throughout the study | Numeric Values |
The purpose of this element is to determine whther or not QST was performed by one investigator |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C18022 | Data point exceed safety parameter description text | DataPtExceedSftyParamDesTxt | Description specifying how the data points that exceeded the safety parameters were handled statistically | Description specifying how the data points that exceeded the safety parameters were handled statistically | If Yes, specify how these data points were handled statistically | Alphanumeric |
If yes, specify how these data points were handled statistically |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism | 255 |
Free-Form Entry |
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C15913 | Quantitative sensory testing stimulation type | QntSnsryTstStmTyp | Type of QST stimulation | Type of QST stimulation | Type of stimulation | Heat;Cold;Pressure;Vibration;Electrical;Other, specify | Heat;Cold;Pressure;Vibration;Electrical;Other, specify | Alphanumeric |
Choose all that apply |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Multiple Pre-Defined Values Selected |
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C15926 | Quantitative sensory testing thermode electrode size value | QntSnsryTstThermdElectrdSizVal | Size of the thermode/electrode used during testing | Size of the thermode/electrode used during testing | Thermode/electrode size | Numeric Values |
Include units |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C18023 | Pain intensity stimulation result | PainIntStimResltScal | Scale of 0-10 used to measure the intensity of the pain resulting from stimulation | Scale of 0-10 used to measure the intensity of the pain resulting from stimulation | Intensity of pain resulting from stimulation on a scale from 0-10 | 0;1;2;3;4;5;6;7;8;9;10;0;1;2;3;4;5;6;7;8;9;10;0;1;2;3;4;5;6;7;8;9;10 | 0 (No pain);;;;;;;;;;10 (Most severe pain);0 (No pain);;;;;;;;;;10 (Most severe pain);0 (No pain);;;;;;;;;;10 (Most severe pain) | Numeric values |
Investigators shuold provide a definition of pain threshold for their particular study. (Example threshold: 0 = No pain, 10 = Most severe pain) |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Single Pre-Defined Value Selected |
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C15914 | Quantitative sensory testing stimulation anatomic site | QntSnsryTstStmAntmicSteTxt | Body site stimulated for QST | Body site stimulated for QST | Body site stimulated | Alphanumeric |
Indicate body location for stimulation |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism | 255 |
Free-Form Entry |
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C15927 | Quantitative sensory testing increase stimulation rate value | QntSnsryTstIncrStimRateVal | Rate of increase of stimulation used during testing | Rate of increase of stimulation used during testing | Rate of increase of stimulation | Numeric Values |
Include units (e.g. degree Celsius/second) |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
Celsius per second | ||||||||||||||||||||||||||||||
C18024 | Temperature skin unit of measure | TempSkinUOM | The units of measure for participant/subject's baseline skin temperature | The units of measure for participant/subject's baseline skin temperature | Participant/subject's baseline skin temperature | F;C;F;C | degrees Fahrenheit;degrees Celsius;degrees Fahrenheit;degrees Celsius | Alphanumeric | No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Single Pre-Defined Value Selected |
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C15915 | Trial performed count | TrialPerfCt | Number of times test was performed. | Number of times test was performed. | Number of times test was performed | Numeric Values |
If more than one, specify method used to combine data from individual tests |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C15928 | Quantitative sensory testing decrease stimulation rate value | QntSnsryTstDecrStimRateVal | Rate of decrease of stimulation used during testing | Rate of decrease of stimulation used during testing | Rate of decrease of stimulation | Numeric Values |
Example result is recorded in Celsius per second |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
Celsius/second | ||||||||||||||||||||||||||||||
C19028 | Quantitative sensory testing outcome other text | QSTOutcmeOTH | The free-text field related to 'Quantitative sensory testing outcome type' specifying other text. Type of QST outcome being measured. | The free-text field related to 'Quantitative sensory testing outcome type' specifying other text. Type of QST outcome being measured. | Other, specify | Alphanumeric |
Choose all that apply and define the type of outcome(s) chosen. Investigators should provide a definition of pain threshold for their particular study. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism | 4000 |
Free-Form Entry |
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C15916 | Statistical method used text | StatMethdUsedTxt | Details specifying the statistical method used to combine data if test was performed more than once. | Details specifying the statistical method used to combine data if test was performed more than once. | If more than one, specify method used to combine data from individual tests | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism | 255 |
Free-Form Entry |
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C15929 | Quantitative sensory testing stimulus duration | QntSnsryTstStimDur | Duration of stimulus used during testing | Duration of stimulus used during testing | Stimulus duration | Numeric Values |
No additional comments |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C19029 | Quantitative sensory testing stimulation other text | QSTStmOTH | The free-text field related to 'Quantitative sensory testing stimulation type' specifying other text. Type of QST stimulation | The free-text field related to 'Quantitative sensory testing stimulation type' specifying other text. Type of QST stimulation | Other, specify | Alphanumeric |
Choose all that apply |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism | 4000 |
Free-Form Entry |
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C15918 | Quantitative sensory testing test methodology type | QntSnsryTstTstMethdTyp | Type of methodology used for QST imaging | Type of methodology used for QST imaging | Testing methodology | Method of limits;Method of levels;Other, specify | Method of limits;Method of levels;Other, specify | Alphanumeric |
Choose all the apply |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Multiple Pre-Defined Values Selected |
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C15930 | Quantitative sensory testing stimulus duration unit of measure | QntSnsryTstStimDurMeasrUnit | The units used to measure duration of stimuli | The units used to measure duration of stimuli | Stimulus duration | seconds;minutes | seconds;minutes | Alphanumeric |
Choose one |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Single Pre-Defined Value Selected |
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C19030 | Quantitative sensory testing test methodology other text | QSTTstMethdOTH | The free-text field related to 'Quantitative sensory testing test methodology type' specifying other text. Type of methodology used for QST imaging | The free-text field related to 'Quantitative sensory testing test methodology type' specifying other text. Type of methodology used for QST imaging | Other methodology used, specify | Alphanumeric |
Choose all the apply |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism | 4000 |
Free-Form Entry |
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C15920 | Quantitative sensory testing test equipment text | QntSnsryTstTstEquipTxt | Description of equipment used for testing | Description of equipment used for testing | Equipment used for testing | Alphanumeric |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism | 255 |
Free-Form Entry |
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C15931 | Quantitative sensory testing vibration electrical stimuli frequency value | QntSnsryTstVibElecStmFreqVal | Frequency of vibration or electrical stimuli used during testing | Frequency of vibration or electrical stimuli used during testing | Frequency of vibration or electrical stimuli used | Numeric values |
Include the units |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C55774 | Imaging headache relation time type | ImagHeadacheRelTimeTyp | The type of timing of the imaging in relation to headache. | The type of timing of the imaging in relation to headache. | Timing of recordings | Inter-Ictal;Ictal;Peri-Ictal | Inter-Ictal;Ictal;Peri-Ictal | Alphanumeric |
Report the timing of recordings in relation to the headache. The precise time windows for peri-ictal and inter-ictal vary with headache type. For episodic migraine, an interval of at least 72h from the lat and before the next attack is generallaccepted for "inter-ictal". |
Adult;Pediatric | Supplemental | 1.00 | 2017-05-31 12:14:56.0 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Single Pre-Defined Value Selected |
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C15921 | Quantitative sensory testing maximum stimulation intensity value | QntSnsryTstMaxStmIntstyVal | Measure of the maximum level of stimulation used during the testing | Measure of the maximum level of stimulation used during the testing | Maximum intensity of stimulation (e.g. maximum temperature, maximum pressure; include units of measurement) | Alphanumeric |
Examples include maximum temperature and, maximum pressure. Include units of measurement. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism | 255 |
Free-Form Entry |
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C15932 | Quantitative sensory testing stimulus rest period duration | QntSnsryTstStmRestPdDur | Duration between stimulus rest periods/intertrial intervals | Duration between stimulus rest periods/intertrial intervals | Duration between stimuli/intertial intervals | Numeric Values |
No additional instructions |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C55775 | Imaging ictal pain intensity value | ImagIctPainIntensVal | The value related to the intensity of the subject's pain if the timing is ictal | The value related to the intensity of the subject's pain if the timing is ictal | If ictal, pain intensity at the time of recordings | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2017-05-31 12:19:15.0 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
0 | 10 | |||||||||||||||||||||||||||||||
C01580 | Temperature unit of measure | TempUOM | Unit of measure for the temperature numerical value | Unit of measure for the temperature numerical value | Exam room temperature at the time of testing | F;C;F;C | degrees Fahrenheit;degrees Celsius;degrees Fahrenheit;degrees Celsius | Alphanumeric |
Indicate the units used to measure temperature- degrees Celsius (°C) or degrees Fahrenheit (°F). |
Unified Code for Units of Measure - http://unitsofmeasure.org/ | Adult;Pediatric | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Single Pre-Defined Value Selected |
2956267 | ||||||||||||||||||||||||||||
C15922 | Quantitative sensory testing maximum stimulus duration | QntSnsryTstMaxStmDur | Maximum duration of stimuli used during the testing | Maximum duration of stimuli used during the testing | Maximum duration of stimuli | Numeric Values |
Indicate numeric value of maximum stimuli in seconds or minutes |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C15933 | Quantitative sensory testing stimulus rest period duration unit of measure | QntSnsryTstStmRstPdDurMeasrUnt | The units used to measure duration between stimulus rest periods | The units used to measure duration between stimulus rest periods | Duration between stimuli/intertial intervals | seconds;minutes | seconds;minutes | Alphanumeric |
Choose one |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Single Pre-Defined Value Selected |
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C55776 | Imaging ictal headache since onset duration | ImagIctHeadSinceOnsetDur | The duration of time since the onset of the subject's headache if it was ictal. | The duration of time since the onset of the subject's headache if it was ictal. | If ictal, duration of time since onset of headache (include units) | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2017-05-31 12:21:21.0 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C15910 | Assessment date and time | AssessDateTime | The date of participant's injury | The date of participant's injury | Date of test | Date or Date & Time |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C15923 | Quantitative sensory testing maximum stimuli duration unit of measure | QntSnsryTstMaxStmDurMeasrUnt | The units used to measure maximum stimuli | The units used to measure maximum stimuli | Maximum duration of stimuli | seconds;minutes | seconds;minutes | Alphanumeric |
Choose one |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Single Pre-Defined Value Selected |
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C15934 | Temperature skin measurement | TempSkinMeasr | The participant/subject's baseline skin temperature | The participant/subject's baseline skin temperature | Participant/subject's baseline skin temperature | Numeric Values |
Indicate numeric value of baseline skin temperature recorded in degrees Fahrenheit or Celsius |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C55777 | Imaging inter peri ictal headache since end duration | ImagInterPeriIctHeadSincEndDur | The duration of time since the end of the subject's last inter-ictal or peri-ictal headahe. | The duration of time since the end of the subject's last inter-ictal or peri-ictal headahe. | If inter-ictal or peri-ictal, duraton of time since end of last headache (include units) | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2017-05-31 12:23:34.0 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Free-Form Entry |
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C15911 | Quantitative sensory testing outcome type | QntSnsryTstOutcmeTyp | Type of QST outcome being measured. | Type of QST outcome being measured. | Outcome | Pain threshold;Pain tolerance threshold;Detection threshold;Other, specify | Pain threshold;Pain tolerance threshold;Detection threshold;Other, specify | Alphanumeric |
Choose all that apply and define the type of outcome(s) chosen. Investigators should provide a definition of pain threshold for their particular study. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Multiple Pre-Defined Values Selected |
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C15924 | Data point exceed safety parameter indicator | DataPtExceedSftyParamInd | Indicates whether there were any data points that exceeded the safety parameters | Indicates whether there were any data points that exceeded the safety parameters | Were there any data points that exceeded the safety parameters noted above? | Yes;No | Yes;No | Alphanumeric |
If yes, specify how these data points were handled statistically |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Quantitative Sensory Testing (QST) | Outcomes and End Points | Pain Mechanism |
Single Pre-Defined Value Selected |