CDE Detailed Report

Disease: Parkinson's Disease
Sub-Domain: Other Non-Motor
CRF: Other Non-motor Guidelines for CDE Use

Displaying 1 - 25 of 25
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
C10176 Peak Expiratory Flow Rate Percentage value PeakExpiratoryFlowRatePctVal Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR) Numeric Values

Normal range is 80-100%

http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

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C10187 Videofluoroscopic swallowing study liquid type VFSSLiquidTyp Type of liquid used in the Videofluoroscopic Swallowing Study (VFSS) Type of liquid used in the Videofluoroscopic Swallowing Study (VFSS) Thin liquid;Thick liquid;High volume;Puree;Solid Thin liquid;Thick liquid;High volume;Puree;Solid Alphanumeric

Answer for all swallow efforts

Assessment: http://www.nature.com/gimo/contents/pt1/fig_tab/gimo95_T2.html Penetration Aspiration Rating Scale: http://www.nature.com/gimo/contents/pt1/fig_tab/gimo95_T5.html Dysphagia Severity Rating Scale: http://www.nature.com/gimo/contents/pt1/fig_ Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

Single Pre-Defined Value Selected

C10166 Quantitative sudomotor axon reflex test (QSART) - resting skin temperature anatomic site QSARTRestingSkinTempAnatSite Location on body where probes are placed to obtain resting skin temperature from quantitative sudomotor axon reflex test (QSART). Location on body where probes are placed to obtain resting skin temperature Arms;Legs;Both arms and legs Arms;Legs;Both arms and legs Alphanumeric http://www.neurology.upmc.edu/neuromuscular/patient_info/testing.html Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

Single Pre-Defined Value Selected

C10177 Slow vital capacity percent of predicted normal value SlowVitalCapPcntPredctdNormVal Value representing the percentage of the predicted normal value of Slow Vital Capacity (sVC) to grade the severity of the abnormality, where sVC is the total amount of air that can be blown out leisurely after a maximal deep breath. Value representing the percentage of the predicted normal value of Slow Vital Capacity (sVC) to grade the severity of the abnormality, where sVC is the total amount of air that can be blown out leisurely after a maximal deep breath. Numeric Values

Normal range is 80-120% predicted

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0 150 percent
C10188 Videofluoroscopic swallowing study penetration aspiration scale VFSSPenetrationAspirationScale Penetration aspiration scale of the Videofluoroscopic Swallowing Study (VFSS) Penetration aspiration scale of the Videofluoroscopic Swallowing Study (VFSS) 1;2;3;4;5;6;7;8 1;2;3;4;5;6;7;8 Numeric Values

Answer for all swallow efforts

Assessment: http://www.nature.com/gimo/contents/pt1/fig_tab/gimo95_T2.html Penetration Aspiration Rating Scale: http://www.nature.com/gimo/contents/pt1/fig_tab/gimo95_T5.html Dysphagia Severity Rating Scale: http://www.nature.com/gimo/contents/pt1/fig_ Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

Single Pre-Defined Value Selected

C10167 Quantitative sudomotor axon reflex test (QSART) - resting skin temperature measurement QSARTRestingSkinTempMeasr Resting Skin Temperature at a "normal" state from quantitative sudomotor axon reflex test (QSART). Resting Skin Temperature at a "normal" state Numeric Values http://www.neurology.upmc.edu/neuromuscular/patient_info/testing.html Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

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C10178 Diffusion Capacity Uncorrected measurement DiffusnCapacityUncorrectdMeasr Diffusion Capacity Uncorrected (DLCO UNC) = Participant/subject is asked to take a deep breath of air containing known concentration of carbon monoxide and to hold it for 10 seconds. The terminal (alveolar air) portion of expiration is collected to measure Diffusion Capacity Uncorrected (DLCO UNC) = Participant/subject is asked to take a deep breath of air containing known concentration of carbon monoxide and hold it for 10 seconds. The terminal (alveolar air) portion of expiration is collected to measure. Numeric Values http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

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C10189 Videofluoroscopic swallowing study dysphagia severity rating scale VFSSDysphagiasSverityRatingScl Dysphagia severity rating scale of the Videofluoroscopic Swallowing Study (VFSS) Dysphagia severity rating scale of the Videofluoroscopic Swallowing Study (VFSS) 0;1;2;3;4;5;6 0;1;2;3;4;5;6 Numeric Values

Answer for all swallow efforts

Assessment: http://www.nature.com/gimo/contents/pt1/fig_tab/gimo95_T2.html Penetration Aspiration Rating Scale: http://www.nature.com/gimo/contents/pt1/fig_tab/gimo95_T5.html Dysphagia Severity Rating Scale: http://www.nature.com/gimo/contents/pt1/fig_ Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

Single Pre-Defined Value Selected

C10168 Quantitative sudomotor axon reflex test (QSART) - resting skin temperature unit of measurement QSARTRestingSkinTemperatureUOM Unit resting skin temperature is measured from quantitative sudomotor axon reflex test (QSART). Unit resting skin temperature is measured F;C degrees Fahrenheit;degrees Celsius Alphanumeric http://www.neurology.upmc.edu/neuromuscular/patient_info/testing.html Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

Single Pre-Defined Value Selected

C10179 Diffusion Capacity Corrected measurement DiffusionCapacityCorrectdMeasr Diffusion Capacity Corrected (DLCO CORR) = A correction for predicted value is made using patients Hemoglobin Diffusion Capacity Corrected (DLCO CORR) = A correction for predicted value is made using patients Hemoglobin Numeric Values

Normal range is 75-125% predicted

http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

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C18769 Thermoregulatory sweat test sweat chemical other text TSTSweatChemicalOTH The free-text field related to 'Thermoregulatory sweat test sweat chemical type' specifying other text. Chemical used for Thermoregulatory Sweat Test (TST) that shows a significant color change when mingled with sweat The free-text field related to 'Thermoregulatory sweat test sweat chemical type' specifying other text. Chemical used for Thermoregulatory Sweat Test (TST) that shows a significant color change when mingled with sweat Alphanumeric http://www.medicalhealthtests.com/articles/134/medical-tests/thermoregulatory-sweat-test.html Adult Supplemental 1.00 2014-05-27 13:34:46.0 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points 4000

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C10169 Quantitative sudomotor axon reflex test (QSART) - resting sweat output value QSARTRestingSweatOutputVal Amount of sweat that the participant/subject produces at a "normal" state from quantitative sudomotor axon reflex test (QSART). Amount of sweat that the participant/subject produces at a "normal" state Numeric Values http://www.neurology.upmc.edu/neuromuscular/patient_info/testing.html Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

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C10180 Thermoregulatory sweat test sweat chemical type TSTSweatChemicalTyp Chemical used for Thermoregulatory Sweat Test (TST) that shows a significant color change when mingled with sweat Chemical used for Thermoregulatory Sweat Test (TST) that shows a significant color change when mingled with sweat Corn starch;Sodium carbonate;Alizarin red;Other, specify Corn starch;Sodium carbonate;Alizarin red;Other, specify Alphanumeric http://www.medicalhealthtests.com/articles/134/medical-tests/thermoregulatory-sweat-test.html Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

Multiple Pre-Defined Values Selected

C10170 Quantitative sudomotor axon reflex test (QSART) - results QSARTReslt Overall results of quantitative sudomotor axon reflex test (QSART). Overall results of QSART test Abnormal;Normal Abnormal;Normal Alphanumeric http://www.neurology.upmc.edu/neuromuscular/patient_info/testing.html Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

Single Pre-Defined Value Selected

C10181 Thermoregulatory sweat test sweat chemical text TSTSweatChemicalTxt If chemical used on participant/subject for Thermoregulatory Sweat Test (TST) is not listed, record here If chemical used on participant/subject for Thermoregulatory Sweat Test (TST) is not listed, record here Alphanumeric http://www.medicalhealthtests.com/articles/134/medical-tests/thermoregulatory-sweat-test.html Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points 255

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C10171 Trial number TrialNum The number representing the sequence for any repeated measure test or assessment when it is performed multiple times. The number representing the sequence for any repeated measure test or assessment when it is performed multiple times. Trial 1;Trial 2;Trial 3 Trial 1;Trial 2;Trial 3 Alphanumeric Beck M, Giess R, Wuerffel W, Magnus T, Ochs, G, Toyka KV. Comparison of Maximal Voluntary Isometric Contraction and Drachman's Hand-Held Dynamometry in Evaluating Patients with Amyotrophic Lateral Sclosis. Muscle Nerve. 1999; 22: 1265-1270. Bohannon RW. Hand-Held Dynamometry; Stability of Muscle Strength Over Multiple Measurements. Clinical Biomechanics. 1986: 2:74-77. Wang CY, Olson SL, Protas EJ. Test-Retest Strength Reliability: Hand-Held Dynamometry in Community-Dwelling Elderly Faller. Arch Phys Med Rehabil. 2002; 83: 811-5. Shefner J, Cudkowicz ME, Maragakis N, Cedarbaum JM, Lee J, Jones D, Watson ML, Shaver K, Chen M, Saikali K, Mao J, Russell AK, Hansen L, Malik F, Wolff AA, for the NEALS/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in Amyotrophic Lateral Sclerosis. (submitted for publication) http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

Single Pre-Defined Value Selected

C10182 Thermoregulatory sweat test baseline room temperature value TSTBaselineRoomTemperatureVal Baseline (starting) temperature of the room the participant/subject is placed in for Thermoregulatory Sweat Test (TST) Baseline (starting) temperature of the room the participant/subject is placed in for Thermoregulatory Sweat Test (TST) Numeric Values http://www.medicalhealthtests.com/articles/134/medical-tests/thermoregulatory-sweat-test.html Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

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C10172 Forced vital capacity result ForcedVitalCapacityReslt Value representing the Forced Vital Capacity (FVC), in Liters, as the maximum volume of air that can be exhaled as rapidly, forcefully, and completely as possible from the point of maximal inhalation. Value representing the Forced Vital Capacity (FVC), in Liters, as the maximum volume of air that can be exhaled as rapidly, forcefully, and completely as possible from the point of maximal inhalation. Numeric Values

Results recorded in liters for each trial

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liter
C10183 Thermoregulatory sweat test 30 minutes elapsed room temperature value TST30MinElapsedRoomTempVal Temperature of the room which induced the participant/subject to sweat for 30 minutes during the Thermoregulatory Sweat Test (TST) Temperature of the room which induced the participant/subject to sweat for 30 minutes during the Thermoregulatory Sweat Test (TST) Numeric Values http://www.medicalhealthtests.com/articles/134/medical-tests/thermoregulatory-sweat-test.html Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

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C10173 Forced expiratory volume second result ForcedExpiratoryVolumSecondRes Value representing the Amount of air, in Liters, that can be blown in the first second in the FVC maneuver (FEV1) Value representing the Amount of air, in Liters, that can be blown in the first second in the FVC maneuver (FEV1) Numeric Values http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm Adult Supplemental 3.00 2013-07-22 16:57:17.79 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

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liter
C10184 Thermoregulatory sweat test room temperature unit of measurement TSTRoomTempUOM Unit temperature is measured in for the Thermoregulatory Sweat Test (TST) Unit temperature is measured in for the Thermoregulatory Sweat Test (TST) F;C degrees Fahrenheit;degrees Celsius Alphanumeric http://www.medicalhealthtests.com/articles/134/medical-tests/thermoregulatory-sweat-test.html Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

Single Pre-Defined Value Selected

C10174 FEV1/FVC percentage value FEV1FVCPercentageVal Forced Expired Volume in One Second (FEV1) volume divided by Forced Vital Capacity (FVC), expressed as percent Forced Expired Volume in One Second (FEV1) volume divided by Forced Vital Capacity (FVC), expressed as percent Numeric Values

Observed percent less than 75% is indicative of obstruction

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C10185 Thermoregulatory sweat test intensity color change value TSTIntensityColorChangeVal Intensity of the color change of the chemical on participant/subject's body during the Thermoregulatory Sweat Test (TST) Intensity of the color change of the chemical on participant/subject's body during the Thermoregulatory Sweat Test (TST) Alphanumeric

The intensity of the color change correlates with functioning of the autonomous nervous system

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C10175 FEF25-75 percentage value FEF2575PercentageVal Forced expiratory flow rate between 25 to 75% of FVC (Used to be known as maximal mid expiratory flow rate) Forced expiratory flow rate between 25 to 75% of FVC (Used to be known as maximal mid expiratory flow rate) Numeric Values

Normal range is 75-125%

http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

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C10186 Videofluoroscopic swallowing study swallow effort number VFSSSwallowEffortNum Each swallow effort of the Videofluoroscopic Swallowing Study (VFSS) is numbered; first swallow effort is numbered 1, second swallow effort is numbered 2, etc. Each swallow effort of the Videofluoroscopic Swallowing Study (VFSS) is numbered; first swallow effort is numbered 1, second swallow effort is numbered 2, etc. 1;2;3;4;5;6;7 1;2;3;4;5;6;7 Numeric Values Assessment: http://www.nature.com/gimo/contents/pt1/fig_tab/gimo95_T2.html Penetration Aspiration Rating Scale: http://www.nature.com/gimo/contents/pt1/fig_tab/gimo95_T5.html Dysphagia Severity Rating Scale: http://www.nature.com/gimo/contents/pt1/fig_ Adult Supplemental 3.00 2013-07-22 09:34:41.527 Other Non-motor Guidelines for CDE Use Other Non-Motor Outcomes and End Points

Single Pre-Defined Value Selected

CSV