CDE Detailed Report
Subdomain Name: Patient Reported Outcomes
CRF: welcome
Displaying 1 - 7 of 7
| CDE ID | CDE Name | Variable Name | Definition | Short Description | 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 / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C15966 | Diary day headache indicator | DiaryDayHeadachInd | Indicator of whether the participant/subject experienced a headache on a particular day | Indicator of whether the participant/subject experienced a headache on a particular day | Headache | Yes;No | Yes;No | Alphanumeric |
If 'Yes' answered, the appropriate Headache Record CRF (Acute or Preventive) must be completed for each yes capturing additional information about the headache. |
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study. | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-16 14:01:43.01 | Headache Calendar | Patient Reported Outcomes | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C15967 | Diary day migraine indicator | DiaryDayMigrnInd | Indicator of whether the participant/subject thought the headache was a migraine | Indicator of whether the participant/subject thought the headache was a migrain | Migraine | Yes;No | Yes;No | Alphanumeric |
A migraine is defined as pain in the head that includes at least 2 or more of the following features (1. throbbing; 2. pain in front, side, or back of head; 3. moderate or severe pain; 4. worsens with activity) AND 1 or more of the following 2 associated symptoms (1. nausea and/or vomiting; 2. light/sound sensitivity). If yes is answered for Headache or Migraine, complete the appropriate Headache Record CRF (Acute or Preventive) for EACH headache/migraine day. |
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study. | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-16 14:01:43.01 | Headache Calendar | Patient Reported Outcomes | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C22804 | Pain present eleven point intensity scale | PainPrsnt11IntensityScl | Scale for the participant's current pain intensity based on an a scale of 0-10 | Scale for the participant's current pain intensity based on an a scale of 0-10 | Severity | 0;1;10;2;3;4;5;6;7;8;9 | 0;1;10;2;3;4;5;6;7;8;9 | Numeric Values |
On a scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, how bad is your headache right now? |
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study. | Adult;Pediatric | Supplemental-Highly Recommended | 4.00 | 2023-05-18 16:39:30.0 | Headache Calendar | Patient Reported Outcomes | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C56042 | Headache severity scale | HeadacheSeverityScale | The scale of the amount of headache the participant/subject is experiencing | The scale of the amount of headache the participant/subject is experiencin | Severity | Mild;Moderate;Severe;None | Mild;Moderate;Severe;None | Alphanumeric | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-06-05 14:46:52.0 | Headache Calendar | Patient Reported Outcomes | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C56043 | Headache migraine onset time | HeadMigOnsetTime | The time that the subject's headache started | The time that the subject's headache starte | Time Onset | Date or Date & Time |
Record the start and end time according to the ISO 8601, the International Standard for the representation of dates and times. 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.). |
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-06-05 14:58:03.0 | Headache Calendar | Patient Reported Outcomes | Outcomes and End Points |
Free-Form Entry |
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| C56044 | Headache migraine end time | HeadMigEndTime | The time that the subject's headache ended | The time that the subject's headache ende | Time End | Date or Date & Time |
Record the start and end time according to the ISO 8601, the International Standard for the representation of dates and times. 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.). |
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-06-05 14:58:03.0 | Headache Calendar | Patient Reported Outcomes | Outcomes and End Points |
Free-Form Entry |
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| C10626 | Condition diary date and time | CondDiaryDateTime | Date (and time, if applicable and known) the diary data are recorded | Date (and time, if applicable and known) the diary data are recorded | Date | 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.). |
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study. | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-08-28 16:08:00.453 | Headache Calendar | Patient Reported Outcomes | Outcomes and End Points |
Free-Form Entry |
