CDE Detailed Report
Disease: Spinal Muscular Atrophy
Subdomain Name: Pulmonary Function Testing/Respiratory Status
CRF: Pulmonary Function Testing
Displaying 1 - 28 of 28
Subdomain Name: Pulmonary Function Testing/Respiratory Status
CRF: Pulmonary Function Testing
Displaying 1 - 28 of 28
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C12516 | Pulmonary function lung function measurement | PulmnryFunctLungFunctMeasr | Numeric result of index function of the lungs tested | Numeric result of index function of the lungs tested | Trial 1,2, or 3 | Alphanumeric |
Record the numeric result for each function test trial performed. The following units should be used for each function trial result: FVC (liters) FEV1 (liters) FEV1/FVC (ratio/ no units) FEV0.5 (liters) FEV0.5/FVC (ratio/ no units) FEF25-75 (liters/ second) FEFmax (liters/ second) PCF (liters/ second) TLC (liters) SVC (liters) IC (liters) FRC (liters) RV (liters) FRC/TLC (ratio/ no unit) RV/TLC (ratio/ no unit) MEP (cm of water) MIP (cm of water) |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points | 255 |
Free-Form Entry |
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| C11098 | Pulmonary function test date and time | PulmFuncTestDateTime | Date (and time, if applicable and known) the pulmonary function test was performed | Date (and time, if applicable and known) the pulmonary function test was performed | Date of Pulmonary Function Testing | 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.). |
No references available | Adult;Pediatric | Core | 3.10 | 2024-02-29 15:59:28.0 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
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| C12308 | Pulmonary function test bronchodilator indicator | PulmnryFunctTstBronchdltrInd | Whether the patient was taking bronchodilator during the time of testing | Whether the patient was taking bronchodilator during the time of testing | Was the patient taking bronchodilator at time of testing | Yes;No | Yes;No | Alphanumeric |
This is a pediatric-specific element |
No references available | Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C17874 | Pulmonary function test not done indicator | PulmnryFunctTstNotDoneInd | Was the pulmonary function test not done | Was the pulmonary function test not done | Date of Pulmonary Function Testing | Yes | Yes | Alphanumeric | No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C11099 | Pulmonary function test type | PulmFunctTestTyp | Type of pulmonary function testing performed | Type of pulmonary function testing performed | What type of pulmonary function testing is being perfomed | 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 below. Position should be consistent for all trials |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Multiple Pre-Defined Values Selected |
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| C12310 | Pulmonary function complete exhalation indicator | PulmnryFunctComplteExhalInd | Whether the complete amount of air was exhaled from the participant/subject | Whether the complete amount of air was exhaled from the participant/subject | Exhalation | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
To be answered for each trial performed |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C17875 | Pulmonary function test text | PulmnryFunctTstTxt | Other type of pulmonary function testing performed | Other type of pulmonary function testing performed | What type of pulmonary function testing is being perfomed | Alphanumeric | No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points | 255 |
Free-Form Entry |
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| C11100 | Pulmonary function test position type | PulmFuncTestPositionTyp | Participant's/subject's position for the pulmonary function assessment | Participant's/subject's position for the pulmonary function assessment | Position for the assessment | Sitting;Supine;Both | Sitting;Supine;Both | Alphanumeric |
Please note that "Supine" is for FVC only. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C12311 | Pulmonary function index of lung function type | PulmnryFunctIndLungFunctTyp | The different functions of the lungs tested during pulmonary function test (PFT) | The different functions of the lungs tested during pulmonary function test (PFT) | Index of Lung Function | FVC;FEV1;FEV1/FVC;FEV0.5;FEV0.5/FVC;FEF25-75;FEFmax;PCF;TLC;SVC;IC;FRC;RV;FRC/TLC;RV/TLC;MEP;MIP;SNIP | FVC;FEV1;FEV1/FVC;FEV0.5;FEV0.5/FVC;FEF25-75;FEFmax;PCF;TLC;SVC;IC;FRC;RV;FRC/TLC;RV/TLC;MEP;MIP;SNIP | Alphanumeric | No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C17876 | Pulmonary function test not done text | PulmnryFunctTstNotDoneTxt | If the PFT was not performed on the participant/subject, specify other reason | If the PFT was not performed on the participant/subject, specify other reason | Reason not done | Alphanumeric | No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points | 255 |
Free-Form Entry |
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| C11101 | Pulmonary function test mouth apparatus type | PulmFuncTestMouthApparTyp | Type of mouthpiece used for the pulmonary function test | Type of mouthpiece used for the pulmonary function test | What type of mouthpiece was used? | Scuba;Mask;Cardboard | Scuba;Mask;Cardboard | Alphanumeric |
Nose clips are required for all testing |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C12312 | Pulmonary function index of lung function best trial measurement | PulmFuncIndLungFuncBstMeasr | The best trial of the index of lung function trials performed for pulmonary function test (PFT) measures | The best trial of the index of lung function trials performed for PFT measures | Best Trial | Alphanumeric |
Record the Best cumulative index of lung function trial for: FVC; FEV1; FEV1/FVC; FEV0.5; FEV0.5/FVC; FEF25-75; FEFmax; and PCF Record the Best individual index of lung function trial for: TLC; SVC; IC; FRC; RV; FRC/TLC; RV/TLC; MEP; and MIP |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points | 255 |
Free-Form Entry |
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| C18833 | Pulmonary function test not done other text | PulmnryFunctTstNotDoneOTH | The free-text field related to 'Pulmonary function test not done reason' specifying other text. Reason the pulmonary function test was attempted but not completed | The free-text field related to 'Pulmonary function test not done reason' specifying other text. Reason the pulmonary function test was attempted but not complete | Other, specify | Alphanumeric |
Only answered if Not Done was checked for PFT Date |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points | 4000 |
Free-Form Entry |
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| C12298 | Pulmonary function test not done reason | PulmnryFunctTstNotDoneRsn | Reason the pulmonary function test was attempted but not completed | Reason the pulmonary function test was attempted but not complete | Reason not done | Fatigue;URI/LRI/severe coughing;Behavioral issues;Equipment failure;Unable to follow directions;Low oral motor tone/unable to hold mouthpiece;Unable to get subject into supine position due to scoliosis, contractures, cannot move to bed;Other, specify | Fatigue;Upper respriatory infection (URI)/lower respiratory infection (LRI)/severe coughing;Behavioral issues;Equipment failure;Unable to follow directions;Low oral motor tone/unable to hold mouthpiece;Unable to get subject into supine position due to scoliosis, contractures, cannot move to bed (for supine only);Other, specify | Alphanumeric |
Only answered if Not Done was checked for PFT Date |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Multiple Pre-Defined Values Selected |
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| C12313 | Pulmonary function maximal pressure trial difference indicator | PulmnFuncMaxPressTrDiffInd | Whether each trial for maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) had a difference greater than 3 cm, measured in centimeters of water | Whether each trial for maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) had a difference greater than 3 cm, measured in centimeters of wate | Was there a difference of greater than 3cm of H20 between trial efforts? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Answered only if MIP and/or MEP assessments are performed. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C18834 | Ulna length measure tool other text | UlnaLngthMeasrToolOTH | The free-text field related to 'Ulna length measure tool name' specifying other text. Instrument used to measure ulna length | The free-text field related to 'Ulna length measure tool name' specifying other text. Instrument used to measure ulna length | Other, specify | Alphanumeric |
This is a pediatric-specific element |
No references available | Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points | 4000 |
Free-Form Entry |
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| C12301 | Pulmonary Function Test seat position type | PulmnryFunctTstSeatPostnTyp | The seated position of the participant/subject during the assessment | The seated position of the participant/subject during the assessment | If assessment performed sitting, what was the subject's seated position? | Semi-erect;Erect;Leaning forward;N/A - assessment done supine | Semi-erect;Erect;Leaning forward;N/A - assessment done supine | Alphanumeric |
Position should remain consistent for all trials. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C12314 | Pulmonary function forced vital capacity cough exhalation indicator | PulmnFunctFVCCghExhltnInd | Whether or not the participant coughed during the first second of exhalation in any trial for forced vital capacity (FVC) | Whether or not the participant coughed during the first second of exhalation in any trial for forced vital capacity (FVC) | Was there a cough during the first second of exhalation? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Answered only if FVC is performed. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C12303 | Pulmonary function test equipment manufacturer name | PulmnryFunctTstEquiqManufNam | Name of manufacturer of the pulmonary function test equipment | Name of manufacturer of the pulmonary function test equipment | Type of Pulmonary Function Testing Equipment Used: Manufacturer | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points | 255 |
Free-Form Entry |
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| C12315 | Pulmonary function forced vital capacity leak indicator | PulmnryFuncFVCLeakInd | Whether or not there was a leak during exhalation in any trial for forced vital capacity (FVC) | Whether or not there was a leak during exhalation in any trial for forced vital capacity (FVC) | Was there a leak during exhalation? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Answered only if FVC is performed. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C12304 | Pulmonary function test equipment model name | PulmnryFunctTstEquipModelNam | Name of model of the pulmonary function test equipment | Name of model of the pulmonary function test equipment | Type of Pulmonary Function Testing Equipment Used: Model | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points | 255 |
Free-Form Entry |
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| C12316 | Pulmonary function forced vital capacity large value range indicator | PulmnrFuncFVCLrgValRngInd | Whether the two largest values of forced vital capacity (FVC) are within 10% of each other | Whether the two largest values of forced vital capacity (FVC) are within 10% of each other | Are the 2 largest values for FVC within 10% of each other? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Answered only if FVC is performed. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C12305 | Pulmonary function test equipment software program name | PlmnryFuncTstEquipSftwrePrgNam | The software program used in the pulmonary function test equipment | The software program used in the pulmonary function test equipment | Type of Pulmonary Function Testing Equipment Used: Software program | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points | 255 |
Free-Form Entry |
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| C12317 | Pulmonary function forced vital capacity early termination indicator | PulmnryFuncFVCErlyTermInd | Whether or not there was early termination with a steep cutoff during the trials for forced vital capacity (FVC) | Whether or not there was early termination with a steep cutoff during the trials for forced vital capacity (FVC) | Was there early termination with steep cut off? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Answered only if FVC is performed. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C12306 | Ulna length measurement | UlnaLngthMeasr | The length of the ulna of the participant/subject | The length of the ulna of the participant/subject | Ulna length | Numeric Values |
If the Date performed on this form is the same as the Date performed on the Vital Signs form, then this field will be pre-populated from the value recorded on the Vital Signs form. For adults whose height cannot be measured or is unknown, arm span length can be used (instead of ulna length), however, arm span length is not a surrogate for height. |
No references available | Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
centimeter | |||||||||
| C12318 | Pulmonary function forced vital capacity peak flow indicator | PulmnryFunctFVCPeakFlowInd | Whether or not there was a clearly defined peak flow during any of the trials for forced vital capacity (FVC) | Whether or not there was a clearly defined peak flow during any of the trials for forced vital capacity (FVC) | Was there a clearly defined peak flow? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Answered only if FVC is performed. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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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 1,2, or 3 | Trial 1;Trial 2;Trial 3 | Trial 1;Trial 2;Trial 3 | Alphanumeric |
Record the 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 | Core | 3.00 | 2013-07-25 08:54:08.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C12307 | Ulna length measure tool name | UlnaLngthMeasrToolNam | Instrument used to measure ulna length | Instrument used to measure ulna length | Ulna length measured with: | Harpenden Anthropometer;Rosscraft segmometer;Other, specify | Harpenden Anthropometer;Rosscraft segmometer;Other, specify | Alphanumeric |
This is a pediatric-specific element |
No references available | Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function Testing | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
