CDE Detailed Report

Disease: Myasthenia Gravis
Sub-Domain: Pulmonary Function Testing/Respiratory Status
CRF: Pulmonary Function Testing

Displaying 1 - 28 of 28
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
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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

C11098 Pulmonary function test date and time PulmFuncTestDateTime Date the pulmonary function test was performed Date 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 Supplemental 3.00 2013-07-24 11:38:01.2 Pulmonary Function Testing Pulmonary Function Testing/Respiratory Status Outcomes and End Points

Free-Form Entry

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 completed. Other, specify Alphanumeric

Only answered if Not Done was checked for PFT Date

No references available Adult;Pediatric Supplemental 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

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 completed. 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 Supplemental 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

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 water. 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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

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 Supplemental 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

CSV