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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Mitochondrial Disease
Sub-Domain: Pulmonary Function Testing/Respiratory Status
CRF: Pulmonary Function
Item count: 19 (19 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C11098
Pulmonary function test date and time
PulmFuncTestDateTime
Date the pulmonary function test was performed
Date of Pulmonary Function Testing (PFT)
  
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.).
ISO 8601 - http://www.iso.org/iso/iso_catalogue.htm
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Pulmonary function test date and time
 
Free-Form Entry
       
C11099
Pulmonary function test type
PulmFunctTestTyp
Type of pulmonary function testing performed
What type of pulmonary function testing is being performed?
Slow Vital Capacity;Maximum Inspiratory Pressure;Maximum Expiratory Pressure;Peak Expiratory Flow;Forced Vital Capacity;Forced Expiratory Volume in one second;
Slow Vital Capacity;Maximum Inspiratory Pressure;Maximum Expiratory Pressure;Peak Expiratory Flow;Forced Vital Capacity;Forced Expiratory Volume in one second;
Alphanumeric
Check all that apply. Record results in appropriate tables on next page. A study should write detailed standard operating procedures (SOPs) for the pulmonary function testing to help ensure consistent measurements. The SOP should cover details like the equipment used, the position of the participant/subject for the measurements, etc.
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Pulmonary function test type
 
Multiple Pre-Defined Values Selected
       
C17832
Pulmonary function maximum inspiratory pressure (MIP) type
PulmFuncMICTyp
Type of Maximum Inspiratory Pressure (MIP)
Specify type below
Sniff Nasal Inspiratory Pressure;Maximal Voluntary Ventilation;
Sniff Nasal Inspiratory Pressure (SNIP);Maximal Voluntary Ventilation (MVV);
Alphanumeric
No instructions available
No references available
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
  
Single Pre-Defined Value Selected
       
C11100
Pulmonary function test position type
PulmFuncTestPositionTyp
Participant's/subject's position for the pulmonary function assessment
Position for the assessment
Sitting;Supine;Both;
Sitting;Supine;Both;
Alphanumeric
Choose one for each pulmonary function test performed. Supine should be used for Forced Vital Capacity (FVC) only.
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Pulmonary function test position type
 
Single Pre-Defined Value Selected
       
C11101
Pulmonary function test mouth apparatus type
PulmFuncTestMouthApparTyp
Type of mouthpiece used for the pulmonary function test
What type of mouthpiece was used (if applicable)?
Scuba;Cardboard;Mask;Tube;Other;
Scuba;Cardboard;Mask;Tube;Other;
Alphanumeric
If applicable
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Pulmonary function test mouth apparatus type
 
Single Pre-Defined Value Selected
       
C10171
Trial number
TrialNum
The number representing the sequence for any repeated measure test or assessment when it is performed multiple times.
Trial
Trial 1;Trial 2;Trial 3;
Trial 1;Trial 2;Trial 3;
Alphanumeric
Record the results for each trial of the specific pulmonary function test
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
3.0
7/25/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Trial number
 
Single Pre-Defined Value Selected
       
C11104
Pulmonary function slow vital capacity (sVC) result value
PulmFuncsVCResltVal
Value, in Liters, representing the slow Vital Capacity (SVC) maximal amount of air exhaled steadily from full inspiration to maximal expiration in liters. Not time-dependent.
sVC Results
  
Numeric Values
Results should be recorded in liters (L) for each trial. If sVC not performed, check N/A
No references available
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Slow vital capacity result
 
Free-Form Entry
  
liter
    
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.
sVC %of Predicted
  
Numeric Values
Please repeat 3 times in assessment.
http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Slow vital capacity percent of predicted normal value
 
Free-Form Entry
0
150
percent
    
C11105
Pulmonary function maximal inspiratory pressure (MIP) result value
PulmFuncMIPResltVal
Value, in cm H2O, representing the percentage of the predicted normal value of Maximal Inspiratory Pressure (MIP) a measure of the strength of respiratory muscles.
MIP Results
  
Numeric Values
Results should be recorded in centimeters of water (cm H2O) for each trial. If MIP not performed, check N/A
No references available
Adult
Exploratory
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Maximal inspiratory pressure result
 
Free-Form Entry
  
centimeter of water
    
C11106
Pulmonary function maximal expiratory pressure (MEP) result value
PulmFuncMEPResltVal
Value, representing the percentage of the predicted normal value of Maximal Expiratory Pressure (MEP) a measure of the strength of respiratory muscles.
MEP Results
  
Numeric Values
Results should be recorded in centimeters of water (cm H2O) for each trial. If MEP not performed, check N/A.
No references available
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Maximal expiratory pressure result
 
Free-Form Entry
  
centimeter of water
    
C11107
Pulmonary function peak expiratory flow result value
PulmFuncPEFResltVal
Value representing the Peak Expiratory Flow (PEF) as a person's maximum speed of expiration.
PEF Results
  
Numeric Values
Results should be recorded in liters per minute (L/min) for each trial. If PEF not performed, check N/A.
No references available
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Peak expiratory flow result
 
Free-Form Entry
  
liter per minute
    
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)
FEV1 Results
  
Numeric Values
Please repeat 3 times in assessment.
http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Forced expiratory volume in one second result
 
Free-Form Entry
  
liter
    
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.
FVC Results
  
Numeric Values
Please repeat 3 times in assessment.
http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Forced vital capacity result
 
Free-Form Entry
  
liter
    
C11109
Pulmonary function forced vital capacity (FVC) flow volume crossed x-axis indicator
PulmFunFVCFlowVolCrossXAxisInd
Whether the Forced Vital Capacity (FVC) flow volume crossed the x-axis
FVC Flow volume crossed X-axis
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. Answer for each trial performed.
No references available
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Forced vital capacity flow volume crossed x-axis indicator
 
Single Pre-Defined Value Selected
       
C11110
Pulmonary function sniff nasal inspiratory pressure (SNIP) result value
PulmFuncSNIPResltVal
Value representing the Sniff Nasal Inspiratory Pressure (SNIP), in cm H2O, as a measure of global inspiratory muscle strength.
SNIP Results
  
Numeric Values
Results should be recorded in liters (L) for each trial. If SNIP not performed, check N/A.
No references available
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Sniff nasal inspiratory pressure result
 
Free-Form Entry
  
centimeter of water
    
C11111
Pulmonary function sniff nasal inspiratory pressure (SNIP) peak pressure value
PulmFuncSNIPPeakPressrVal
Value representing the peak Sniff Nasal Inspiratory Pressure (SNIP), in cm H2O, of three trials
SNIP Peak Pressure Value
  
Numeric Values
Results should be recorded in liters (L)
No references available
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Sniff nasal inspiratory pressure peak pressure value
 
Free-Form Entry
  
centimeter of water
    
C02411
Laterality type
LatTyp
Laterality type relative to the anatomic site of the body examined or affected
Nare
  
Alphanumeric
Choose one
Kendall. Muscles: Testing and Function with Posture and Pain, 5th ed. Florence JM, Pandya S, King WM et al. Intrarater reliability of manual muscle test (Medical Research Council Scale) grades in Duchenne's muscular dystrophy. Phys Ther 1992;72:115-126.
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Laterality type
 
Single Pre-Defined Value Selected
       
C11114
Pulmonary function sniff nasal inspiratory pressure (SNIP) congestion indicator
PulmFuncSNIPCongestionInd
Indicator as to whether or not the participant/subject has nasal congestion when Sniff Nasal Inspiratory Pressure (SNIP) was measured
Nasal Congestion
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
This question is answered for SNIP
No references available
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Sniff nasal inspiratory pressure nasal congestion indicator
 
Single Pre-Defined Value Selected
       
C11112
Pulmonary function maximal voluntary ventilation (MVV) result value
PulmFuncMVVResltVal
Value representing the Maximal Voluntary Ventilation, in Liters per Minute, as the greatest volume of gas that can be breathed per minute by voluntary effort.
MVV Results
  
Numeric Values
Results should be recorded in liters per minute (L/min) for each trial. If MVV not performed, check N/A.
No references available
Adult
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Pulmonary Function
Pulmonary Function Testing/Respiratory Status
Outcomes and End Points
Maximal voluntary ventilation result
 
Free-Form Entry
  
liter per minute
    
07-21-2019
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