CDE Detailed Report

Disease: Myasthenia Gravis
Sub-Domain: Global Outcome
CRF: Myasthenia Gravis Composite - MGC

Displaying 1 - 11 of 11
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
C16608 Myasthenia Gravis Composite (MGC) - shoulder abduct weak score MGCShoulderAbductWeakScore Score for weakness in shoulder abduction, as part of the Myasthenia Gravis Composite (MGC) Score for weakness in shoulder abduction, as part of the Myasthenia Gravis Composite (MGC) Shoulder abduction 0;2;4;5 0 = Normal;2 = Mild weakness;4 = Moderate weakness;5 = Severe weakness Numeric Values

Physical examination "Moderate weakness" should be construed as weakness that equals roughly 50% +/- 15% of expected normal strength. Any weakness milder than that would be "mild" and any weakness more severe than that would be classified as "severe".

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C16609 Myasthenia Gravis Composite (MGC) - hip flex weak score MGCHipFlexWeakScore Score for weakness in hip flexion, as part of the Myasthenia Gravis Composite (MGC) Score for weakness in hip flexion, as part of the Myasthenia Gravis Composite (MGC) Hip flexion 0;2;4;5 0 = Normal;2 = Mild weakness;4 = Moderate weakness;5 = Severe weakness Numeric Values

Physical examination "Moderate weakness" should be construed as weakness that equals roughly 50% +/- 15% of expected normal strength. Any weakness milder than that would be "mild" and any weakness more severe than that would be classified as "severe".

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C16610 Myasthenia Gravis Composite (MGC) - total score value MGCTotalScoreVal Value of the sum of all scores recorded, as part of the Myasthenia Gravis Composite (MGC) Value of the sum of all scores recorded, as part of the Myasthenia Gravis Composite (MGC) Total score Numeric Values

Sum of Q1 through Q10.

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Free-Form Entry

C16600 Myasthenia Gravis Composite (MGC) - ptosis up gaze duration score MGCPtosisUpGazeDuratnScore Score for duration of delay before ptosis in upward gaze, as part of the Myasthenia Gravis Composite (MGC) Score for duration of delay before ptosis in upward gaze, as part of the Myasthenia Gravis Composite (MGC) Ptosis, upward gaze 0;1;2;3 0 = > 45 seconds;1 = 11 - 45 seconds;2 = 1 - 10 seconds;3 = Immediate Numeric Values

Physician examination

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C16601 Myasthenia Gravis Composite (MGC) - double vision lateral gaze duration score MGCDblVisnLaterlGzeLftRtDurScr Score for duration of delay before double vision on lateral gaze left or right, as part of the Myasthenia Gravis Composite (MGC) Score for duration of delay before double vision on lateral gaze left or right, as part of the Myasthenia Gravis Composite (MGC) Double vision on lateral gaze, left or right 0;1;3;4 0 = > 45 seconds;1 = 11 - 45 seconds;3 = 1 - 10 seconds;4 = Immediate Numeric Values

Physician examination

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C16602 Myasthenia Gravis Composite (MGC) - eye close weak score MGCEyeCloseWeakScore Score for weakness of eye closure, as part of the Myasthenia Gravis Composite (MGC) Score for weakness of eye closure, as part of the Myasthenia Gravis Composite (MGC) Eye closure 0;0;1;2 0 = Normal;0 = Mild weakness (can be forced open with effort);1 = Moderate weakness (can be forced open easily);2 = Severe weakness (unable to keep eyes closed) Numeric Values

Physician examination

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C16603 Myasthenia Gravis Composite (MGC) - talk clear score MGCTalkClearScore Score for clarity of talking, as part of the Myasthenia Gravis Composite (MGC) Score for clarity of talking, as part of the Myasthenia Gravis Composite (MGC) Talking 0;2;4;6 0 = Normal;2 = Intermittent slurring or nasal speech;4 = Constant slurring or nasal but can be understood;6 = Difficult to understand speech Numeric Values

Patient history

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C16604 Myasthenia Gravis Composite (MGC) - chew fatigue score MGCChewFatigueScore Score for chewing fatigue, as part of the Myasthenia Gravis Composite (MGC) Score for chewing fatigue, as part of the Myasthenia Gravis Composite (MGC) Chewing 0;2;4;6 0 = Normal;2 = Fatigue with solid food;4 = Fatigue with soft food;6 = Gastric tube Numeric Values

Patient history

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C16605 Myasthenia Gravis Composite (MGC) - swallow difficult score MGCSwallowDifficultScore Score for difficulty swallowing, as part of the Myasthenia Gravis Composite (MGC) Score for difficulty swallowing, as part of the Myasthenia Gravis Composite (MGC) Swallowing 0;2;5;6 0 = Normal;2 = Rare episode of choking or trouble swallowing;5 = Frequent trouble swallowing, e.g. necessitating changes in diet;6 = Gastric tube Numeric Values

Patient history

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C16606 Myasthenia Gravis Composite (MGC) - breath difficult score MGCBreathDifficultScore Score for difficulty breathing, as part of the Myasthenia Gravis Composite (MGC) Score for difficulty breathing, as part of the Myasthenia Gravis Composite (MGC) Breathing 0;2;4;9 0 = Normal;2 = Shortness of breath with exertion;4 = Shortness of breath at rest;9 = Ventilator dependence Numeric Values

Thought to be caused by MG

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

C16607 Myasthenia Gravis Composite (MGC) - neck flex extend weak score MGCNeckFlexExtendWeakScore Score for weakest neck flexion or extension, as part of the Myasthenia Gravis Composite (MGC) Score for weakest neck flexion or extension, as part of the Myasthenia Gravis Composite (MGC) Neck flexion or extension, weakest 0;1;3;4 0 = Normal;1 = Mild weakness;3 = Moderate weakness;4 = Severe weakness Numeric Values

Physical examination "Moderate weakness" should be construed as weakness that equals roughly 50% +/- 15% of expected normal strength. Any weakness milder than that would be "mild" and any weakness more severe than that would be classified as "severe".

Burns TM, Conaway MR, Cutter GR, Sanders DB The construction of an efficient evaluative instrument for myasthenia gravis: the MG Composite. Muscle and Nerve;2008;38:1553-1562. Burns TM. History of outcome measures in myasthenia gravis. Muscle Nerve 2010;42:5-13. Burns TM, Conaway MR, Sanders DB and the MG Composite and MG-QOL15 Study Group. The MG Composite: A valid and reliable outcome measure for myasthenia gravis. Neurology 2010; 74:1434-1440. Adult Core 3.00 2013-07-24 21:00:23.88 Myasthenia Gravis Composite - MGC Global Outcome Outcomes and End Points

Single Pre-Defined Value Selected

CSV