CDE Detailed Report

Disease: Spinal Muscular Atrophy
Sub-Domain: Devices
CRF: External Devices - SMA

Displaying 1 - 13 of 13
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 External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C12688 Orthosis knee ankle foot orthosis ischial weight bearing indicator OrthsisKnAnkFoOIschlWgtBrngInd Indicator whether any knee-ankle-foot orthosis (KAFO) currently used by the participant/subject is ischial weight bearing Indicator whether any knee-ankle-foot orthosis (KAFO) currently used by the participant/subject is ischial weight bearing Yes, ischial weight bearing? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Only answer if Knee-ankle-foot Orthosis is answered Yes. Choose one.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 External Devices - SMA Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C12943 Orthosis type OrthosisTyp Type of orthosis (i.e., external orthopedic appliance that prevents or assists the movement of the spine or limbs) Type of orthosis (i.e., external orthopedic appliance that prevents or assists the movement of the spine or limbs) Orthoses Inserts of any type;Supramalleolar orthotic;Ankle-foot orthosis (AFO);Knee-ankle-foot orthosis;Hip-knee-ankle-foot orthosis (HKAFO);Stander;Body jacket/Thoracic-lumbar-sacral orthoses;Reciprocal gait orthoses (RGO);Other, specify Inserts of any type;Supramalleolar orthotic (SMO);Ankle-foot orthosis (AFO);Knee-ankle-foot orthosis (KAFO);Hip-knee-ankle-foot orthosis (HKAFO);Stander;Body jacket/Thoracic-lumbar-sacral orthoses (TLSO);Reciprocal gait orthoses (RGO);Other, specify Alphanumeric

For each orthosis type record if it is used

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 External Devices - SMA Devices Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C17970 Positioning device text PositioningDevTxt Text specification of any positioning device currently used by the participant/subject Text specification of any positioning device currently used by the participant/subject Positioning Devices, specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 External Devices - SMA Devices Treatment/Intervention Data 255

Free-Form Entry

C12673 Position device use indicator PositionDevUseInd Indicator of whether the participant/subject uses any positioning devices Indicator of whether the participant/subject uses any positioning devices Does the participant/subject use positioning devices? Yes, specify;No Yes, specify;No Alphanumeric

Choose one. If a positioning device is used specify the type.

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 External Devices - SMA Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C18870 Mobility device other text MobilityDvcOTH The free-text field related to 'Mobility device type' specifying other text. Type for all mobility devices currently used by the participant/subject The free-text field related to 'Mobility device type' specifying other text. Type for all mobility devices currently used by the participant/subject Other, specify Alphanumeric

For each mobility device type record if it is used

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 External Devices - SMA Devices Treatment/Intervention Data 4000

Free-Form Entry

C12679 Mobility device use indicator MobilityDvcUseInd Whether the participant/subject uses a mobility device (e.g., wheelchair) Whether the participant/subject uses a mobility device (e.g., wheelchair) Does the participant/subject use mobility devices? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Yes(complete section 1)

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 External Devices - SMA Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C18883 Orthosis other text OrthosisOTH The free-text field related to 'Orthosis type' specifying other text. Type of orthosis (i.e., external orthopedic appliance that prevents or assists the movement of the spine or limbs) The free-text field related to 'Orthosis type' specifying other text. Type of orthosis (i.e., external orthopedic appliance that prevents or assists the movement of the spine or limbs) Other, specify Alphanumeric

For each orthosis type record if it is used

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 External Devices - SMA Devices Treatment/Intervention Data 4000

Free-Form Entry

C12682 Orthosis use indicator OrthosisUseInd Whether the participant/subject uses orthosis (i.e., external orthopedic appliance that prevents or assists the movement of the spine or limbs) Whether the participant/subject uses orthosis (i.e., external orthopedic appliance that prevents or assists the movement of the spine or limbs) Does the participant/subject use orthoses? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Yes(complete section 2)

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 External Devices - SMA Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C12683 Mobility device type MobilityDvcTyp Type for all mobility devices currently used by the participant/subject Type for all mobility devices currently used by the participant/subject Mobility Devices Quad cane;Straight cane;Walker;Manual wheelchair;Power wheelchair;Scooter;Other, specify Quad cane;Straight cane;Walker;Manual wheelchair;Power wheelchair;Scooter;Other, specify Alphanumeric

For each mobility device type record if it is used

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 External Devices - SMA Devices Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C12684 Mobility device type use indicator MobltyDevTypUseInd Indicator whether the participant/subject currently uses the selected types of mobility device Indicator whether the participant/subject currently uses the selected types of mobility device Device used? Yes;No;Not applicable;Unknown Yes;No;Not applicable;Unknown Alphanumeric

For each mobility device type record if it is used. Choose one for each device type.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 External Devices - SMA Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C12685 Wheelchair use frequency WheelchairUseFreq Frequency with which the participant/subject uses their wheelchair, if applicable Frequency with which the participant/subject uses their wheelchair, if applicable Wheelchair Yes Full-time;Part-time Full-time;Part-time Alphanumeric

If the participant/subject uses a manual wheelchair or power wheelchair then record the extent of use. Choose one option.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 External Devices - SMA Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C12686 Orthosis type use indicator OrthsisTypUseInd Indicator whether the participant/subject currently uses the selected types of orthosis Indicator whether the participant/subject currently uses the selected types of orthosis Device used? Yes;No;Not applicable;Unknown Yes;No;Not applicable;Unknown Alphanumeric

For each orthosis type record if it is used. Choose one for each device type.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 External Devices - SMA Devices Treatment/Intervention Data

Single Pre-Defined Value Selected

C12687 Orthosis ankle foot orthosis type OrthsisAFOTyp Type of any ankle-foot orthosis (AFO) currently used by the participant/subject Type of any ankle-foot orthosis (AFO) currently used by the participant/subject Ankle-foot orthosis (AFO) Yes Solid;Articulating;(DAFO) Solid;Articulating;Dynamic ankle-foot orthosis (DAFO) Alphanumeric

Only answer if Ankle-foot Orthosis is answered Yes. Choose all that apply.

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 External Devices - SMA Devices Treatment/Intervention Data

Multiple Pre-Defined Values Selected

CSV