CDE Detailed Report

Disease: Duchenne Muscular Dystrophy/Becker Muscular Dystrophy
Subdomain Name: Pulmonary Function Testing/Respiratory Status
CRF: Pulmonary Function Testing

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 / 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
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 No references available Adult;Pediatric Supplemental-Highly Recommended 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
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 references available Adult;Pediatric Supplemental-Highly Recommended 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 No references available Adult;Pediatric Supplemental-Highly Recommended 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 references available Adult;Pediatric Supplemental-Highly Recommended 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
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 No references available Adult;Pediatric Supplemental-Highly Recommended 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 Exploratory 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
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 No references available Adult;Pediatric Supplemental-Highly Recommended 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
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 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. <br /><br />Bohannon RW. Hand-Held Dynamometry; Stability of Muscle Strength Over Multiple Measurements. Clinical Biomechanics. 1986: 2:74-77. <br /><br />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. <br /><br />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-Highly Recommended 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 No references available Pediatric Exploratory 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
C18319 Pulmonary function test best trial number PulmFunctTestBestTrialNum The number of the best pulmonary function testing trial The number of the best pulmonary function testing trial Check if Best Trial Trial 1;Trial 2;Trial 3 Trial 1;Trial 2;Trial 3 Alphanumeric No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-21 12:11:21.037 Pulmonary Function Testing Pulmonary Function Testing/Respiratory Status Outcomes and End Points

Single Pre-Defined Value Selected
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 No references available Adult;Pediatric Supplemental-Highly Recommended 3.10 2024-02-29 15:59:28.0 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 bronchodulator at time of testing Yes;No;Unknown Yes;No;Unknown 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
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 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
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 No references available Adult;Pediatric Supplemental-Highly Recommended 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 No references available Pediatric Exploratory 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
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-Highly Recommended 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-Highly Recommended 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
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;Cardboard;Mask;Tube;Other Scuba;Cardboard;Mask;Tube;Other Alphanumeric No references available Adult;Pediatric Supplemental-Highly Recommended 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
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 No references available Adult;Pediatric Supplemental-Highly Recommended 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
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 Attemped, but failed, indicate reason 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 No references available Adult;Pediatric Supplemental-Highly Recommended 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
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 No references available Adult;Pediatric Supplemental-Highly Recommended 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
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 No references available Adult;Pediatric Supplemental-Highly Recommended 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
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 No references available Adult;Pediatric Supplemental-Highly Recommended 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 references available Adult;Pediatric Supplemental-Highly Recommended 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
CSV