CDE Detailed Report

Disease: Traumatic Brain Injury
Sub-Domain: Global Outcome
CRF: Glasgow Outcome Scale Extended (GOSE) Pediatric Revision

Displaying 1 - 17 of 17
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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C20338 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Information obtain type GOSEPInfoObtain The type as related to how the information was obtained The type as related to how the information was obtaine Information obtained In person;By phone;From records In person;By phone;From records Alphanumeric

Note: The scale presented here is not based on the original article. It has become common practice in clinical trial administration to use this modified version that places the scores in reverse order (i.e., "good recovery" = 1, "moderate disability" =2, etc.).

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20349 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Extent restriction social leisure activity little decrease participation indicator GOSEPSocLeisParticBitLessInd The indicator related to a bit less participate in social and leisure activities The indicator related to a bit less participate in social and leisure activitie Participate a bit less: At least half as often as before injury. No;Yes No;Yes Alphanumeric

Module: What is the extent of restrictions on social and leisure activities?

If Yes, register Lower Good Recovery and skip to end of form and record GOS-E Peds Score = 2. If No, skip to 6.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20339 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Consciousness indicator GOSEPConsciousnessInd Indicator related to ability of the head-injured child to obey simple commands or say any words. For younger children, indicates ability to act/react/interact beyond reflexes Indicator related to ability of the head-injured child to obey simple commands or say any words. For younger children, indicates ability to act/react/interact beyond reflexe Is the head-injured person able to obey simple commands or say any words? For younger patients, can he or she act/react/interact beyond reflexes? No;Yes No;Yes Alphanumeric

If No, register Vegetative State (VS) and skip to end of form and record GOS-E Peds Score = 7.

An individual who shows the ability to obey even simple commands or utter any word or communicate specifically in any other way is no longer considered to be in a vegetative state. Eye movements are not reliable evidence of meaningful responsiveness; corroborate with nursing staff and the child's parents when possible. Confirmation of VS requires full assessment as in the Royal College of Physician Guidelines. However, for infants, actively following the movement of a parent or people/object with eyes, grasping for objects, making faces, etc. are interactions; breast feeding and crying continuously can be reflexes.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20350 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Family friendship psychological problem indicator GOSEPFamFrindshpInd Indicates if there are psychological problems that have resulted in ongoing disruption with respect to either family or friendships Indicates if there are psychological problems that have resulted in ongoing disruption with respect to either family or friendships Are there psychological problems that have resulted in ongoing disruption with respect to either family or friendships? No;Yes No;Yes Alphanumeric

If Yes, go to 6b. If No, skip to 7.

Typical post-traumatic personality changes: quick temper, irritability, anxiety, aggressive acts, insensitivity to others, mood swings, depression, and unreasonable or childish behavior that is not age appropriate

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20340 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Assistance home requirement indicator GOSEPAsstNeedInd Indicates if the assistance of another person at home is essential for some activities of daily living. For younger children, indicates if the child is dependent upon a caretaker more than it is expected based on age Indicates if the assistance of another person at home is essential for some activities of daily living. For younger children, indicates if the child is dependent upon a caretaker more than it is expected based on ag Is the assistance of another person at home essential every day for some activities of daily living? For younger patients, is the child dependent upon a caretaker more so than is expected based on age? No;Yes No;Yes Alphanumeric

If Yes, go to 2b. If No, skip to 3.

For an older child, complete independence and a 'no' answer should mean that the person can get washed, put on clean clothes without prompting, prepare food for themselves, deal with callers, and handle minor domestic crises. The person should be able to carry out activities without needing prompting or reminding, and should be capable of being left alone for an age appropriate period. Young children should be able to accomplish age appropriate developmental milestones without assistance (see Vineland Daily Living Skills). If a child compensates for physical disability to the point where developmental milestones are only mildly compromised, question parents to determine the level of independence (i.e., a child with a hemiparesis who is still able to complete tasks that other children of that age can be rated as independent).

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20351 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Extent disruption family friendship type GOSEPExtntDisrFamFrindshp The extent of disruption or strain in family and friendship due to injury The extent of disruption or strain in family and friendship due to injur What is the extent of disruption or strain? Occasional - less than weekly;Unknown;Constant - daily and intolerable;Frequent - once a week or more, but tolerable Occasional - less than weekly;Unknown;Constant - daily and intolerable;Frequent - once a week or more, but tolerable Alphanumeric

If "Constant – daily and intolerable", register Lower Moderate Disability and skip to end of form and record GOS-E Peds Score = 4. If "Frequent – once a week or more, but tolerable", register Upper Moderate Disability and skip to end of form and record GOS-E Peds Score = 3. If "Occasional – less than weekly", register Lower Good Recovery and skip to end of form and record GOS-E Peds Score = 2.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20341 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Frequent assistance home need indicator GOSEPFreqntHlpNeedInd Indicates if the child needs frequent help or for someone to be around at home most of the time. For younger children, indicates that the child needs frequent help from a caretaker to accomplish tasks relevant for his/her age Indicates if the child needs frequent help or for someone to be around at home most of the time. For younger children, indicates that the child needs frequent help from a caretaker to accomplish tasks relevant for his/her age Does the child need frequent help or for someone to be around at home most of the time? For younger patients, does the child need frequent help from a caretaker to accomplish tasks that a child this age should be able to accomplish (If child sometimes functions at an age appropriate level, then answer 'yes.') No;Yes No;Yes Alphanumeric

If child sometimes functions at an age appropriate level, then answer Yes. If Yes, register Lower Severe Disability and skip to end of form and record GOS-E Peds Score = 6. If No, register Upper Severe Disability and skip to end of form and record GOS-E Peds Score = 5.

For an older child, complete independence and a 'no' answer should mean that the person can get washed, put on clean clothes without prompting, prepare food for themselves, deal with callers, and handle minor domestic crises. The person should be able to carry out activities without needing prompting or reminding, and should be capable of being left alone for an age appropriate period. Young children should be able to accomplish age appropriate developmental milestones without assistance (see Vineland Daily Living Skills). If a child compensates for physical disability to the point where developmental milestones are only mildly compromised, question parents to determine the level of independence (i.e., a child with a hemiparesis who is still able to complete tasks that other children of that age can be rated as independent).

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20352 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Return normal life other problem indicator GOSEPCrrntOthProbInd The indicator related to other problem in returning to normal life The indicator related to other problem in returning to normal lif Are there any other problems relating to the injury that affect daily life? No;Yes No;Yes Alphanumeric

If Yes, register Lower Good Recovery and skip to end of form and record GOS-E Peds Score = 2. If No, register Upper Good Recovery and skip to end of form and record GOS-E Peds Score = 1.

Typical problems reported after head injury: headaches, dizziness, tiredness, sensitivity to noise or light, slowness, memory failures, concentration problems, or other problems.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20342 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Shop travel without assistance indicator GOSEPShpTrvlWoutAsstInd Indicates if the child is able to shop and travel without assistance. For younger children, indicates if the child behave age appropriately outside the home Indicates if the child is able to shop and travel without assistance. For younger children, indicates if the child behave age appropriately outside the hom Is the child able to shop and travel without assistance? For younger patients, does the child behave age appropriately outside the home? No;Yes No;Yes Alphanumeric

If yes, skip to 4. If No, register Upper Severe Disability and skip to end of form and record GOS-E Peds Score = 5.

This item considers activities such as shopping and traveling, always in the context of age appropriate behaviors. This includes being able to plan what to buy, take care of money, and behave appropriately in public. The individual need not normally shop, but must be able to do so. A younger child must behave age appropriately in public. An older child may drive or use public transit to get around. Ability to use a taxi is sufficient, provided the person can phone for it themselves and give instruction the driver. Older children who sometimes were allowed to travel independently before the injury should be able to walk to a neighbor's house, take a school bus, ride a bike, or take public transportation.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20343 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Current work school function pre-injury capacity indicator GOSEPCrrntWrkSchlInd Indicates if the child can function at work or in school at their previous capacity Indicates if the child can function at work or in school at their previous capacit Can the child function at work or in school at his or her previous capacity? No;Yes No;Yes Alphanumeric

If Yes, skip to 5. If No, go to 4b.

If an adolescent was working before the injury, then his or her current capacity for work should be at the same level. If the individual was seeking work before, then the injury should not have adversely affected chances of obtaining work or the level of work for which he or she is eligible. If the patient was in preschool or a student before the injury, then capacity for school work and school activities should not be adversely affected.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20344 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Work school restriction indicator GOSEPWrkSchlRestrictInd Indicates restrictions that apply to child's ability to work and study, including ability to work only in a sheltered workshop or non-competitive job, in a school setting for severely impaired children or tutored at home, or currently unable to work or go to school Indicates restrictions that apply to child's ability to work and study, including ability to work only in a sheltered workshop or non-competitive job, in a school setting for severely impaired children or tutored at home, or currently unable to work or go to schoo Level of restriction: i) Able to work only in a sheltered workshop or non-competitive job, in a school setting for severely impaired children or tutored at home, or currently unable to work or go to school. No;Yes No;Yes Alphanumeric

If Yes, register Lower Moderate Disability and skip to end of form and record GOS-E Peds Score = 4. If No, go to 4bii.

If an adolescent was working before the injury, then his or her current capacity for work should be at the same level. If the individual was seeking work before, then the injury should not have adversely affected chances of obtaining work or the level of work for which he or she is eligible. If the patient was in preschool or a student before the injury, then capacity for school work and school activities should not be adversely affected.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20345 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Reduced work school capacity indicator GOSEPWrkSchlReducedCapacInd Indicates reduced work or school capacity for an injured child Indicates reduced work or school capacity for an injured chil School/work level of restriction: ii) Reduced work or school capacity No;Yes No;Yes Alphanumeric

If Yes, register Upper Moderate Disability and skip to end of form and record GOS-E Peds Score = 3. If No, go to 5.

If an adolescent was working before the injury, then his or her current capacity for work should be at the same level. If the individual was seeking work before, then the injury should not have adversely affected chances of obtaining work or the level of work for which he or she is eligible. If the patient was in preschool or a student before the injury, then capacity for school work and school activities should not be adversely affected.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20346 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Current participation social leisure activity pre-injury indicator GOSEPSocLeisInd Indicates if the child is able to resume regular social and leisure activities Indicates if the child is able to resume regular social and leisure activitie Is the child able to resume regular social and leisure activities? No;Yes No;Yes Alphanumeric

If yes, skip to 6. If No, go to 5b.

The individual may not have resumed all previous leisure activities, but should not be prevented from doing so by physical or mental impairment. If he or she has stopped the majority of activities because of loss of interest or motivation, then this is considered a disability. For younger children, social and leisure activities can include games and toys played with caretakers, siblings or other children as well as the ability to interact in a playful manner with others.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C07434 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Score PGOSEScore Score for the participant, as a part of the Pediatric Glasgow Outcome Scale - Extended (PGOSE) Score for the participant, as a part of the Pediatric Glasgow Outcome Scale - Extended (PGOSE Glasgow Outcome Scale -Extended, Pediatric Revision 8;7;6;5;4;3;2;1 Death;Vegetative State (VS);Lower Severe Disability (Lower SD);Upper Severe Disability (Upper SD);Lower Moderate Disability (Lower MD);Upper Moderate Disability (Upper MD);Lower Good Recovery (Lower GR);Upper Good Recovery (Upper GR) Numeric Values

Note: The scale presented here is not based on the original article. It has become common practice in clinical trial administration to use this modified version that places the scores in reverse order (i.e., "good recovery" = 1, "moderate disability" =2, etc.).

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C20347 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Extent restriction social leisure activity unable participate indicator GOSEPSocLeisUnablParticInd Indicator related to being unable to participate in social and leisure activities Indicator related to being unable to participate in social and leisure activitie Unable to participate: Rarely, if ever, take part No;Yes No;Yes Alphanumeric

Module: What is the extent of restrictions on social and leisure activities?

If Yes, register Lower Moderate Disability and skip to end of form and record GOS-E Peds Score = 4. If No, go to 5bii.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C18431 Pediatric Glasgow Outcome Scale - Extended, Pediatric Revision (GOS-E Peds) - date time PGOSEDateTime Date and time that the participant performed the Pediatric Glasgow Outcome Scale extended version, as a part of Pediatric Glasgow Coma Scale Extended (PGOSE) Date and time that the participant performed the Pediatric Glasgow Outcome Scale extended version, as a part of Pediatric Glasgow Coma Scale Extended (PGOSE Date and time of Glasgow Outcome Scale -Extended, Pediatric Revision Date or Date & Time

Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.

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.).

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Free-Form Entry

C20348 Pediatric Glasgow Outcome Scale - Extended (GOS-E Peds) - Extent restriction social leisure activity much decrease participation indicator GOSEPSocLeisParticMuchLessInd Indicator related to being much less able to participate in social and leisure activities Indicator related to being much less able to participate in social and leisure activitie Participate much less: Less than half as often. No;Yes No;Yes Alphanumeric

Module: What is the extent of restrictions on social and leisure activities?

If Yes, register Upper Moderate Disability and skip to end of form and record GOS-E Peds Score = 3. If No, go to 5biii.

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. Epub 2012 Apr 10. Pediatric Supplemental 3.00 2015-03-11 10:21:26.0 Glasgow Outcome Scale Extended (GOSE) Pediatric Revision Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

CSV