CDE Detailed Report

Disease: Congenital Muscular Dystrophy
Sub-Domain: General Health History
CRF: Interval Medical History

Displaying 1 - 47 of 47
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
C19846 Medical history tracheostomy since last visit indicator MedHistTracheostomySLVInd Indicator of tracheostomy since last visit indicator Indicator of tracheostomy since last visit indicator Have you had a tracheostomy since your last visit? No;Yes No;Yes Alphanumeric

Any new tracheostomy since the last visit should be recorded on the Surgical and Hospital History.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19878 Meical history anxiety development since last visit indicator MedHistAnxDvlpmntSLVInd Indicator of anxiety since last study visit Indicator of anxiety since last study visit Have you developed anxiety since your last study visit? No;Yes No;Yes Alphanumeric

Development of anxiety since the last visit should be recorded on the AE CRF.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19857 Medical history new contracture since last visit indicator MelHistCntrcturesSLVInd Indicator of new contractures since last study visit Indicator of new contractures since last study visit Have you had any new contractures since your last study visit? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19868 Medical history congenital muscular dystrophy Limb-Girdle muscular dystrophy genetic confirmation spectrum disorder since last visit indicator MedHistCMDLGMDGntCnSLVInd Indicator of genetic confirmation of CMD to LGMD spectrum since last visit Indicator of genetic confirmation of CMD to LGMD spectrum since last visit Have you had a genetic confirmation of CMD to LGMD spectrum disorder since your last visit? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19847 Medical history bilevel positive airway pressure ventilator since last visit indicator MedHistBiPAPVentltrSLVInd Indicator of bilevel positive airway pressure or ventilator adjusted since last visit Indicator of bilevel positive airway pressure or ventilator adjusted since last visit Have your BiPAP/Ventilator settings been adjusted since your last visit? No;Yes No;Yes Alphanumeric

Review NIV (BiPAP/Ventilator settings on Intake Medical History with Family

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19879 Medical history upper respiratory infection since last visit indicator MedHistURISLVInd Indicator of upper respiratory infections since last study visit Indicator of upper respiratory infections since last study visit Have you had frequent upper respiratory infections (URI) since your last study visit? No;Yes No;Yes Alphanumeric

Any upper respiratory infections since the last visit should be recorded on the AE CR.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19858 Medical history broken bones since last visit indicator MedHistBrknBonesSLVInd Indicator of broken bones since last study visit Indicator of broken bones since last study visit Have you broken a bone since your last study visit? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19869 Medical history gene mutation text MedHistGeneMutatTxt Text specifying which gene has been mutated to confirm CMD to LGMD spectrum Text specifying which gene has been mutated to confirm CMD to LGMD spectrum If Yes, which gene has been identified as mutated? Alphanumeric

Only answered if Interval Disease Progression or Accidents question #10 is Yes

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C19848 Medical History non-invasive ventilation setting type MedHistNIVSettingTyp Type of NIV settings made Type of NIV settings made If Yes, NIV settings: IPAP;EPAP IPAP;EPAP (Expiratory positive airway pressure) Alphanumeric

Only answered if BiPAP settings have been adjusted since the last visit.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19880 Medical history upper respiratory infection frequency MedHistURIFreq Frequency of upper respiratory infection Frequency of upper respiratory infection If Yes, how frequent? None;1-2;3-4;>5 None;1-2;3-4;>5 Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19859 Medical history joint dislocation since last visit indicator MedHistJointDislocSLVInd Indicator of joint dislocations since last study visit Indicator of joint dislocations since last study visit Have you dislocated a joint since your last study visit? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19870 Medical history arrhythmias since last visit indicator MedHistArrhymSLVInd Indicator of arrhythmias since last study visit Indicator of arrhythmias since last study visit Have you had any arrhythmias (heart rhythm problem) since your last study visit? No;Yes No;Yes Alphanumeric

Any arrhythmias since the last visit should be recorded on the AE CRF.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19849 Medical history ventilator setting type MedHistVentltSettingTyp Type of Ventilator settings Type of Ventilator settings If Yes, ventilator settings: Tidal Volume;PEEP;Backup rate Tidal Volume;PEEP;Backup rate Alphanumeric

Only answered if Ventilator settings have been adjusted since the last visit.

No references available Adult;Pediatric Supplemental 2.00 2017-01-26 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19881 Medical history pain since last visit indicator MedHistPainSLVInd Indicator of pain in a new location since last study visit Indicator of pain in a new location since last study visit Have you had pain in a new location since your last study visit? No;Yes No;Yes Alphanumeric

Any pain in a new location since the last visit should be recorded on the AE CRF.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19860 Medical history strength change since last visit status MedHistStrngthChngSLVStat Indicator of change in strength since last study visit Indicator of change in strength since last study visit Have you noticed any change in strength since your last study visit? No change;Yes, I feel stronger;Yes, I feel weaker No change;Yes, I feel stronger;Yes, I feel weaker Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19871 Medical history cardiomyopathy since last visit indicator MedHistCardiomyopathyInd Indicator of cardiomyopathy since last visit Indicator of cardiomyopathy since last visit Have you had cardiomyopathy (enlarged heart) since your last study visit? No;Yes No;Yes Alphanumeric

Any cardiomyopathy since the last visit should be recorded on the AE CRF.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19850 Medical history non-invasive ventilation adjusted setting text MedHistNIVAdjTxt Text specifying any adjustments made to non-invasive ventilation settings Text specifying any adjustments made to non-invasive ventilation settings If Yes, NIV settings: Alphanumeric

Only answered if BiPAP settings have been adjusted since the last visit. Record any adjustments made to BiPAP settings.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C19882 Medical history pain location anatomic site MedclHistPainLocAnatSite Anatomic site of pain Anatomic site of pain If Yes, which joints had pain? Neck;Shoulder;Elbows;Wrists;Fingers;Hips;Knees;Ankles Neck;Shoulder;Elbows;Wrists;Fingers;Hips;Knees;Ankles Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19861 Medical history roll in bed unassisted since last visit status MedHistRollBedAssiSLVStatus Status of assistance needed to roll over in bed since last study visit Status of assistance needed to roll over in bed since last study visit Are you able to roll over in bed unassisted? Yes, I can roll over completely from back to front;Yes, I can roll to my side;No, I cannot roll over on my own Yes, I can roll over completely from back to front;Yes, I can roll to my side;No, I cannot roll over on my own Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19872 Medical history urinary tract infection since last visit indicator MedHistUTISLVInd Indicator of UTI since last study visit Indicator of UTI since last study visit Have you had frequent urinary tract infections (UTI) since your last study visit? No;Yes No;Yes Alphanumeric

Any urinary tract infections since the last visit should be recorded on the AE CRF.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19840 Medical history medication change since last visit indicator MedHistMedctnChngeSLVInd Indicator of medication changes since last study visit Indicator of medication changes since last study visit Have you had any medication changes since your last visit? No;Yes No;Yes Alphanumeric

Any new medications since the last visit should be recorded on the Prior and Concomitant Medications CRF.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19851 Medical history ventilator adjusted setting text MedHistVentltAdjTxt Text specifying any adjustments made to ventilator settings Text specifying any adjustments made to ventilator settings If Yes, ventilator settings: Alphanumeric

Only answered if Ventilator settings have been adjusted since the last visit. Record any adjustments made to Ventilator settings. Tidal volume should be reported in "ml" units

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C19883 Motor function history type MotorFuncHistTyp Type of motor function Type of motor function Motor Function Able to run;Able to climb stairs using a handrail;Able to walk indoors without assistnace > 10 steps;Able to walk outdoors without assistance > 10 steps;Able to walk with assistance (including walker, calipers, of KAFOs);Able to sit when placed;Able to hold head up Able to run;Able to climb stairs using a handrail;Able to walk indoors without assistnace > 10 steps;Able to walk outdoors without assistance > 10 steps;Able to walk with assistance (including walker, calipers, of KAFOs);Able to sit when placed;Able to hold head up Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19862 Medical history stumble since last visit indicator MedHistStmblInd Indicator of stumbling since last study visit Indicator of stumbling since last study visit If walking, have you been falling or stumbling (tripping) more often since your last visit? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19873 Medical history urinary tract infection since last visit frequency MedHistUTISLVFreq Frequency of UTI since last visit Frequency of UTI since last visit If Yes, how frequent? 0;1-2;3-4;>5 0;1-2;3-4;>5 Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19841 Medical history illness since last visit indicator MedHistIllnessSLVInd Indicator of illness since last study visit Indicator of illness since last study visit Have you had any illnesses since your last study visit(s)? No;Yes No;Yes Alphanumeric

Any new illnesses since the last visit should be recorded on the Surgical and Hospital History.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19852 Medical history aspiration choking since last visit indicator MedHistAspirChokeSLVInd Indicator of aspiration or choking since last study visit Indicator of aspiration or choking since last study visit Have you had any aspiration or choking episodes since your last visit? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19884 Motor function history maintain indicator MotorFuncHistMaintnInd Indicator of motor function history maintained Indicator of motor function history maintained Still maintained? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19863 Medical history self feed increase difficulty indicator MedHistSelfFeedIncDifInd Indicator of self-feed difficulty Indicator of self-feed difficulty Has it become more difficult to feed yourself? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19874 Medical history scoliosis development since last visit indicator MedHistScolDvlpmntSLVInd Indicator of scoliosis development since last visit Indicator of scoliosis development since last visit Have you developed scoliosis since your last study visit? No;Yes No;Yes Alphanumeric

If the participant/subject developed scoliosis since the last visit, it should be recorded on the AE CRF.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19842 Medical history hospitalizations since last visit indicator MedHistHosptlSLVInd Indicator of hospitilizations since last study visit Indicator of hospitilizations since last study visit Have you had any hospitalizations since your last study visit(s)? No;Yes No;Yes Alphanumeric

Any new hospitalizations since the last visit should be recorded on the Surgical and Hospital History.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19853 Medical history cough assist since last visit indicator MedHistCghAstSLVInd Indicator of cough assist since last visit Indicator of cough assist since last visit Have you started using mechanical in/ex-sufflation (cough assist) since your last visit? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19885 Motor function history age lost function value MotorFuncHistAgeLostFuncVal Age lost number Age lost number Age lost (years) Numeric Values

Age should be recorded in years

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Free-Form Entry

0 100 Years old
C19864 Medical history physical therapy change since last visit indicator MedHistPTChngSLVInd Indicaor of change in physical therapy since last visit Indicaor of change in physical therapy since last visit Have you had a change in how much physical therapy you receive since your last visit? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19875 Medical history seizures since last visit indicator MedHistSeizSLVInd Indicator of seizures since last visit Indicator of seizures since last visit Have you had any seizures since your last study visit? No;Yes No;Yes Alphanumeric

Any seizures since the last visit should be recorded on the AE CRF.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19843 Medical history emergency room visits since last visit indicator MedHistEmrgyRmSLVInd Indicator of emergency room visits since last study visit Indicator of emergency room visits since last study visit Have you had any ER visits since your last study visit(s)? No;Yes No;Yes Alphanumeric

Any new ER visits since the last visit should be recorded on the Surgical and Hospital History.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19854 Medical history scoliosis surgery since last visit indicator MedHistScolSurgSLVInd Indicator of scoliosis surgery since last study visit Indicator of scoliosis surgery since last study visit Have you had any scoliosis surgeries since your last study visit? No;Yes No;Yes Alphanumeric

Any new scoliosis surgery since the last visit should be recorded on the Surgical and Hospital History.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19886 Motor function history lost function date MotorFuncHistLostFuncDt Date of motor function lost Date of motor function lost Date Lost (YYYY/MM) Date or Date & Time

Date should be recorded in the format MM/YYYY.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Free-Form Entry

C19865 Medical history physical therapy change since last visit frequency MedHistPTChngSLVFreq Frequency of change in physical therapy since last visit Frequency of change in physical therapy since last visit If Yes, how much change in physical therapy since your last visit? Increased;Decreased;Don't go to physical therapy Increased;Decreased;Don't go to physical therapy Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19844 Medical history wheezing since last visit indicator MedHistWheezeSLVInd Indicator of wheezing since last visit Indicator of wheezing since last visit Have you had any wheezing since your last visit? No;Yes No;Yes Alphanumeric

Any new incidents of wheezing since the last visit should be recorded on the Surgical and Hospital History.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19876 Medical history behavior issue since last visit indicator MedHistBehvrIssueSLVInd Indicator of behavioral issues since last visit Indicator of behavioral issues since last visit Have you had behavioral issues since your last study visit? No;Yes No;Yes Alphanumeric

Any behavioral issues since the last visit should be recorded on the AE CRF.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19855 Medical history other surgery since last visit indicator MedHistOthSurgSLVInd Indicator of other surgery performed since last study visit Indicator of other surgery performed since last study visit Have you had any other surgery since your last study visit? No;Yes No;Yes Alphanumeric

Any new surgery since the last visit should be recorded on the Surgical and Hospital History.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19866 Medical history speech therapy since last visit indicator MedHistSpchThrpySLVInd Indicator of change in speech therapy since last visit Indicator of change in speech therapy since last visit Have you had a change in how much speech therapy you receive since your last visit? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19845 Medical history intubated since last visit indicator MedHistIntubatedSLVInd Indicator of intubation since last study visit Indicator of intubation since last study visit Have you been intubated since your last visit? No;Yes No;Yes Alphanumeric

Any new incidents of intubation since the last visit should be recorded on the Surgical and Hospital History.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19877 Medical history depression since last visit indicator MedHistDepressSLVInd Indicator of depression since last study visit Indicator of depression since last study visit Have you developed depression since your last study visit? No;Yes No;Yes Alphanumeric

Development of depression since the last visit should be recorded on the AE CRF.

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19856 Medical history gastrostomy tube since last visit indicator MedHistGtubeSLVInd Indicator of Gtube placed since last study visit Indicator of Gtube placed since last study visit Have you had a G-Tube placed since your last study visit? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19867 Medical history speech therapy since last visit frequency MedHistSpchThrpySLVFreq Frequency of change in speech therapy since last visit Frequency of change in speech therapy since last visit If Yes, how much change in speech therapy since your last visit? Increased;Decreased;Don't go to speech therapy Increased;Decreased;Don't go to speech therapy Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Interval Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

CSV