CDE Detailed Report

Disease: Spinal Cord Injury
Sub-Domain: General Health History
CRF: Medical History

Displaying 1 - 50 of 51
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 / 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
C18168 Total cholesterol value TotCholstrlVal Total cholesterol level measured Total cholesterol level measured Total cholesterol (TC) Numeric Values

Dyslipidemias may be worsened by a reduction in the serum HDL cholesterol value in those with acute or chronic SCI. Therefore, to have the ability to determine the effect of SCI per se on the lipid profile, this information, if available, should be provided (if several lipid profiles are available, the most recent values prior to SCI should be provided), along with the date obtained. The units of measurement to be used in this data set are mg/dL.

Bauman WA, Biering-SØrensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Free-Form Entry

milligrams per deciliter
C21665 Death cause ICD-10-CM code DeathCauseICD10CMCode ICD-10-CM code that describes the cause of participant/subject's death ICD-10-CM code that describes the cause of participant/subject's death Primary cause of death Alphanumeric

Record the ICD-10-CM code that corresponds to the primary cause of death

International Classification of Disease, Tenth Revision (ICD-10-CM) - http://www.cdc.gov/nchs/icd/icd10cm.htm Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History 255

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C19178 Pre spinal cord lesion pulmonary condition other text PreSpnlCrdLsnPulmnyCondOTH The free-text field related to "Pre spinal cord lesion pulmonary condition type" specifying other text. Type of pulmonary conditions present before spinal cord lesion The free-text field related to "Pre spinal cord lesion pulmonary condition type" specifying other text. Type of pulmonary conditions present before spinal cord lesion Other, specify Alphanumeric

Other, specify

Biering-SØrensen F, Krassioukov A, Alexander MS, Donovan W, Karlsson AK, Mueller G, Perkash I, William Sheel A, Wecht J, Schilero GJ.International Spinal Cord Injury Pulmonary Function Basic Data Set. Spinal Cord. 2012 Jun; 50(6):418-21. Adult;Pediatric Exploratory 1.00 2014-05-30 15:18:00.0 Medical History General Health History Participant History and Family History 4000

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C06012 Urinary tract impairment unrelate injury indicator UrinTractImpairUnrelInjInd Indicator of urinary tract impairment unrelated to spinal cord lesion. Indicator of urinary tract impairment unrelated to spinal cord lesion Urinary tract impairment unrelated (before) the spinal cord lesion No;Yes, specify;Unknown No;Yes, specify;Unknown Alphanumeric

To be able to evaluate the lower urinary tract function in an individual with spinal cord lesion it is necessary to know if there are any other urinary tract impairments unrelated to the spinal cord lesion. If there have been any urinary tract impairments unrelated to the spinal cord lesion this/these is/are recommended to be written in a text-field, from which it will be possible to retrieve more detailed data when necessary. Because many possible urinary tract impairments exist, it is not practical to give an exact list of impairments. If this information has been documented once and no additional urinary tract impairments unrelated to the spinal cord lesion have been identified it is only necessary fill in this item once, to avoid redundant data.

Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30. Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19210 Degenerative spine disorder surgery caused indicator DegenrtveSpnDisrdSurgCausdInd Indicator for surgery caused by degenerative spine disorder Indicator for surgery caused by degenerative spine disorder If previous surgery due to this No;Yes No;Yes (if more than one repeat the information below) Alphanumeric

Degenerative spine disorders present with aging. The most common disorders are lumbar (Abbas et al. 2010; Yasar et al. 2009) and cervical (Tracy & Bartleson 2010; Fehlings & Arvin 2009) spinal canal stenosis, spondylosis and degenerative systemic disorders (like diffuse idiopathic skeletal hyperostosis (DISH) and rheumatoid arthritis). These disorders typically develop slowly with the spinal cord often adapting to extensive morphological changes before notable
impairment. The onset of impairments is usually slow and insidious and therefore not noticed by individuals for a considerable time. However, the degenerative changes can increase susceptibility to spinal cord lesions from relatively minor insults, e.g. minor falls with mild extension/flexion trauma inducing a central cord syndrome (Matz et al. 2009).

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW,<br />Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:28:19.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C18169 Triglycerides value TriglcrdVal Triglycerides measured Triglycerides measured Triglycerides (TG) Numeric Values

Dyslipidemias may be worsened by a reduction in the serum HDL cholesterol value in those with acute or chronic SCI. Therefore, to have the ability to determine the effect of SCI per se on the lipid profile, this information, if available, should be provided (if several lipid profiles are available, the most recent values prior to SCI should be provided), along with the date obtained. The units of measurement to be used in this data set are mg/dL.

Bauman WA, Biering-S&Oslash;rensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

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milligrams per deciliter
C19179 Pre spinal cord lesion endocrine metabolic condition diagnosed type PreSpnlCrdLsnMtblicCondTyp Type of endocrine & metabolic condition diagnosed before spinal cord lesion Type of endocrine & metabolic condition diagnosed before spinal cord lesion Endocrine & Metabolic conditions diagnosed before the spinal cord lesion Diabetes mellitus;Lipid disorder;Osteoporosis;Thyroid disease;Other, specify;None;Unknown Diabetes mellitus;Lipid disorder;Osteoporosis;Thyroid disease;Other, specify;None;Unknown Alphanumeric

These codes include endocrine and metabolic conditions diagnosed prior to the spinal cord lesion that may negatively impact health and function after spinal cord lesion.

Bauman WA, Biering-S&Oslash;rensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult;Pediatric Exploratory 1.00 2014-06-02 09:42:35.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C06173 Gastrointestinal anal sphincter dysfunction unrelate SCI indicator GasAnlSphDysfncUnrelSClInd Indicator of any gastrointestinal or anal sphincter dysfunction unrelated to SCI. This is gastrointestinal or anal sphincter dysfunction concomitant and thus unrelated to changes in bowel function due to SCI. Indicator of any gastrointestinal or anal sphincter dysfunction unrelated to SCI. This is gastrointestinal or anal sphincter dysfunction concomitant and thus unrelated to changes in bowel function due to SCI. Gastrointestinal or anal sphincter dysfunction unrelated (before) the spinal cord lesion Yes, specify;No;Unknown Yes, specify;No;Unknown Alphanumeric

This is gastrointestinal or anal sphincter dysfunction concomitant and thus unrelated to changes in bowel function due SCI. Functional gastrointestinal disorders, especially irritable bowel syndrome and idiopathic constipation, are very common in the general population. The prevalence depends on the exact definitions used but vary from 5% up to approximately 20% (Jones R and Lydeard S 1992). The presence of functional or other gastrointestinal disorders before SCI may affect symptoms and treatment outcome. Anal sphincter lesions due to childbirth are common and may contribute to fecal incontinence. Many types of gastrointestinal and anal sphincter dysfunction exist and it is therefore impractical to give an exact list of such conditions.

Krogh K et al. International bowel function basic spinal cord injury data set. Spinal Cord 2009;47:230-4 Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19211 Degenerative spine disorder surgery caused description DegenrtveSpnDisrdSurgDescrpn Description of surgery caused by degenerative spine disorder Description of surgery caused by degenerative spine disorder If previous surgery due to this, description Alphanumeric

Degenerative spine disorders present with aging. The most common disorders are lumbar (Abbas et al. 2010; Yasar et al. 2009) and cervical (Tracy & Bartleson 2010; Fehlings & Arvin 2009) spinal canal stenosis, spondylosis and degenerative systemic disorders (like diffuse idiopathic skeletal hyperostosis (DISH) and rheumatoid arthritis). These disorders typically develop slowly with the spinal cord often adapting to extensive morphological changes before notable
impairment. The onset of impairments is usually slow and insidious and therefore not noticed by individuals for a considerable time. However, the degenerative changes can increase susceptibility to spinal cord lesions from relatively minor insults, e.g. minor falls with mild extension/flexion trauma inducing a central cord syndrome (Matz et al. 2009).

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW,<br />Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:32:04.0 Medical History General Health History Participant History and Family History 4000

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C18678 Family history medical condition other text FamHistMedclCondOTH The free-text field related to 'Family history medical condition type' specifying other text. Type of medical condition or health related event for which the family history is taken The free-text field related to 'Family history medical condition type' specifying other text. Type of medical condition or health related event for which the family history is taken Family history of cardiac disease Alphanumeric Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Exploratory 1.00 2014-05-27 13:34:46.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

3165585
C19201 Pre spinal cord lesion endocrine metabolic condition diagnosed other text PreSpnlCrdLsnEncrnCndnDiagOTH The free text field related to "Pre spinal cord lesion endocrine metabolic condition diagnosed type" specifying the other text. Type of pre spinal cord lesion endocrine & metabolic condition The free text field related to "Pre spinal cord lesion endocrine metabolic condition diagnosed type" specifying the other text. Type of pre spinal cord lesion endocrine & metabolic condition Other, specify Alphanumeric Bauman WA, Biering-S&Oslash;rensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult;Pediatric Exploratory 1.00 2014-06-03 11:46:39.0 Medical History General Health History Participant History and Family History 4000

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C06358 Diabetes mellitus type DiabetesMellitusTyp Type of diabetes mellitus Type of diabetes mellitus Diabetes mellitus Type 1;Type 2;Unknown Type 1;Type 2;Unknown Alphanumeric

Choose one
At time of spinal cord lesion, a patient may present with a history of type 1 or type 2 diabetes mellitus (The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, 2003), which may be more difficult to manage after acute spinal cord injury (SCI) due to glucocorticoid administration, heightened stress, variable caloric intake, and severe immobilization; chronic injury may be associated with a further increase in insulin resistance in association with a reduction in muscle mass (i.e., the primary insulin responsive tissue responsible for glucose deposition). The designation of type 1 or type 2 diabetes mellitus is usually determined on clinical judgement. Juvenile-onset patients should be classified as type 1, and all others, as type 2. Appreciated: the patient with type 2 diabetes may have features distinctive of a patient with type 1 diabetes, including a tendency for ketosis, but such patients are classified clinically as insulin-requiring type 2 diabetes. Therefore, the clinician must decide if a patient has type 1 or a type 2 diabetes mellitus.

Bauman WA, Biering-S&Oslash;rensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, Follow-up Report on the Diagnosis of Diabetes Mellitus. Diabetes Care 2003; 26:3160-3167. Adult;Pediatric Exploratory 3.00 2013-07-24 21:00:23.88 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19212 Degenerative spine disorder surgery date DegenrtveSpnDisrdSurgDate Date of surgery caused by degenerative spine disorder Date of surgery caused by degenerative spine disorder Date of surgery 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.).

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW,<br />Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:37:24.0 Medical History General Health History Participant History and Family History

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C18779 Urinary tract impairment unrelate injury specify text UrinaryTractImpairUnrelInjST The free-text field related to 'Urinary tract impairment unrelate injury indicator'. Indicator of urinary tract impairment unrelated to spinal cord lesion. The free-text field related to 'Urinary tract impairment unrelate injury indicator'. Indicator of urinary tract impairment unrelated to spinal cord lesion. If yes, specify Alphanumeric Biering-S&Oslash;rensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30. Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History 4000

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C00312 Body system category BodySysCat Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Body System Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Genitourinary;Hematologic/Lymphatic;Integumentary (skin and/or breast);Musculoskeletal;Neurological;Psychiatric;Respiratory;Other, specify: Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Genitourinary;Hematologic/Lymphatic;Integumentary (skin and/or breast);Musculoskeletal;Neurological;Psychiatric;Respiratory;Other, specify: Alphanumeric

Record the appropriate body system for each line of medical history.

*For specific questions related to cardiovascular, endocrine, respiratory, musculoskeletal, genitourinary, neurological and gastrointestinal systems, please see the Exploratory list of questions which may be applicable.

Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2002895
C19202 Pre spinal cord lesion neuro-musculoskeletal history type PreSpnlCrdLsnNroMscSkelHistTyp Type of neuro-musculoskeletal history prior to spinal cord lesion Type of neuro-musculoskeletal history prior to spinal cord lesion Neuro-Musculoskeletal history before the spinal cord lesion None;Pre-existing congenital deformities of the spine and spinal cord;Pre-existing degenerative spine disorders;Pre-existing systemic neuro-degenerative disorders None;Pre-existing congenital deformities of the spine and spinal cord;Pre-existing degenerative spine disorders;Pre-existing systemic neuro-degenerative disorders Alphanumeric

Any neuro-musculoskeletal disorders preceding the onset of the spinal cord lesion are to be documented. This is important because relevant pre-existing neuromuscular disorders may influence management.

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW, Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 11:51:17.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C06359 Osteoporosis diagnosis method type OstprsisDiagnosMethdTyp Method used to diagnosis osteoporosis Method used to diagnosis osteoporosis Osteoporosis method DXA;Other (e.g. CT, radiograph) DXA;Other (e.g. CT, radiograph) Alphanumeric

Choose one
Osteoporosis present prior to the spinal cord lesion would be expected to be accelerated because of the adverse effects of paralysis and immobilization on the skeleton below the level of SCI (Biering-Sorensen et al. 1990; NIH Consensus Development Panel, 2001; National Osteoporosis Foundation, 2008). The WHO diagnostic classification of osteoporosis cannot be applied to T-scores from measurements other than dual energy x-ray absorptiometry (DXA) at standard measurement sites (i.e., at the femoral neck, total femur, lumbar spine, or one-third radius). If DXA is not performed, the diagnosis of osteoporosis may be suggested if assessed by other diagnostic methods (i.e., x-ray, quantitative computerized tomography (qCT) or peripheral qCT, in conjunction with clinical risk factors (Baim et al. 2008). Therefore, if osteoporosis is to be diagnosed according to accepted guidelines, DXA must be the method used, or if presumptively diagnosed from methods that are not validated to make the diagnosis of osteoporosis, or performed by qualitative methods, this would be designated as Other method (e.g., CT, radiograph).

Bauman WA, Spungen AM, Schwartz E, Wang J, Pierson Jr RN. Continuous Loss of Bone in Chronic Immobilization: A Monozygotic Twin Study. Osteopor Internat 1999; 10: 123-127. Bauman WA, Biering-S&Oslash;rensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Biering-Sorensen F, Bohr HH, Schaadt OP. Longitudinal study of bone mineral content in the lumbar spine, the forearm and the lower extremities after spinal cord injury. Euro J Clin Invest 1990; 20: 330-335. NIH Consensus Development Panel. Osteoporosis is a skeletal disorder characterized by compromised bone strength predisposing to an increased risk of fracture. Bone strength reflects the integration of two main features: bone density and bone quality. JAMA. 2001;285:785-795. Eser P, Frotzler A, Zehnder Y, Wick L, Knecht H, et al. Relationship between the duration of paralysis and bone structure: a pQCT study of spinal cord injured individuals. Bone 2004; 24: 869-880. National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Bone Source. Washington, D.C. 2008. http://www.nof.org/professsionals/clinicians_guide.htm Baim S, Wilson C, Lewiecki E, Luckey M, Downs R. Precision assessment and radiation safety for dual-energy x-ray absorptiometry:: Position paper of the international society for clinical densitometry. Journal of Clinical Densitometry. 2006;8(4):371-378. Adult Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19213 Pre-existing systemic neuro-degenerative disorder specify diagnosis name PreXstSysNroDgnDsrdSpfDiagName Specifies name of pre-existing systemic neuro-degenerative disorder Specifies name of pre-existing systemic neuro-degenerative disorder Specify diagnosis Alphanumeric

Systemic neuro-degenerative disorders comprise conditions like multiple sclerosis, amyotrophic lateral sclerosis and others. They typically occur in adults and are characterized by an acute or chronic progressive course, which can eventually present as tetra/paraplegia.

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW,<br />Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:43:30.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C18785 Gastrointestinal anal sphincter dysfunction unrelate SCI specify text GasAnlSphDysfncUnrelSClST The free-text field related to 'Gastrointestinal anal sphincter dysfunction unrelate SCI indicator'. Gastrointestinal or anal sphincter dysfunction concomitant and thus unrelated to changes in bowel function due to SCI. The free-text field related to 'Gastrointestinal anal sphincter dysfunction unrelate SCI indicator'. Gastrointestinal or anal sphincter dysfunction concomitant and thus unrelated to changes in bowel function due to SCI. If yes, specify Alphanumeric Krogh K et al. International bowel function basic spinal cord injury data set. Spinal Cord 2009;47:230-4 Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History 255

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C00314 Medical history taken date and time MedclHistTakenDateTime Date (and time, if applicable and known) the participant/subject's medical history was taken Date (and time, if applicable and known) the participant/subject's medical history was taken Date medical (and time) history taken 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 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2179659
C19203 Pre-existing congenital deformity specify diagnosis name CongentlDeformSpecifyDiagName Specifies name of pre-existing congenital deformity of the spine and spinal cord Specifies name of pre-existing congenital deformity of the spine and spinal cord Specify diagnosis Alphanumeric

Congenital disorders include malformations or other pathology of bones (infantile idiopathic scoliosis (Dobbs et al. 2002; Pahys et al. 2009), congenital spinal canal stenosis (Kotil et al. 2007), achondroplasia (Laederich and Horton 2010; Benglis and Sandberg 2007)), muscles (muscular dystrophy) or neural tissues (syringohydromyelia). These also include combined multi system/organ disorders such as myelomenigocele (MMC) (Guille et al. 2006; Rajpal et al. 2007), malformations of the craniocervical junction (i.e. Arnold Chiari type, congenital stenosis, Klippel-Feil anomalies etc. ) (Fernandez et al. 2009; Nakamura et al. 2009; Pahys et al. 2009) or tethered cord (Kramer et al. 2009; Iskandar et al. 2001). Sometimes, these conditions are present in early childhood but only become
symptomatic during adolescence or advancing age. This may be due to progression or unmasking of the condition.

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW, Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 14:52:14.0 Medical History General Health History Participant History and Family History 4000

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C17473 Cardiovascular history cardiac surgery date CardioHistCardSurgDate Date of most recent cardiac surgery or mechanical intervention performed on the participant/subject Date of most recent cardiac surgery or mechanical intervention performed on the participant/subject Cardiac surgery, date last performed 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.).

Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Exploratory 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Free-Form Entry

C19214 Pre-existing systemic neuro-degenerative disorder specify anatomic site PreXstSysNroDgnDsrdSpfAntSite Specifies anatomic site of pre-existing systemic neuro-degenerative disorder Specifies anatomic site of pre-existing systemic neuro-degenerative disorder Specify location Alphanumeric

Systemic neuro-degenerative disorders comprise conditions like multiple sclerosis, amyotrophic lateral sclerosis and others. They typically occur in adults and are characterized by an acute or chronic progressive course, which can eventually present as tetra/paraplegia.

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW,<br />Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:48:42.0 Medical History General Health History Participant History and Family History 4000

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C19078 Cardiovascular history cardiac surgery other text CardioHistCardSurgOTH The free-text field related to 'Cardiovascular history cardiac surgery type' specifying other text. Type of cardiac surgery or mechanical intervention the participant/subject underwent The free-text field related to 'Cardiovascular history cardiac surgery type' specifying other text. Type of cardiac surgery or mechanical intervention the participant/subject underwent Cardiac surgery, specify Alphanumeric Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Exploratory 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History 4000

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C00315 Medical history global assessment indicator MedclHistGlobalAssmtInd Indicator of whether the participant/subject has a history of any medical problems/conditions Indicator of whether the participant/subject has a history of any medical problems/conditions Does the participant have a history of any medical problems/conditions in the following body systems? Yes;No Yes;No Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

3145578
C19204 Pre-existing congenital deformity specify anatomic site CongentlDeformSpcfyAntmicSite Anatomic site of pre-existing congenital deformity of spine and spinal cord Anatomic site of pre-existing congenital deformity of spine and spinal cord Specify location Alphanumeric

Congenital disorders include malformations or other pathology of bones (infantile idiopathic scoliosis (Dobbs et al. 2002; Pahys et al. 2009), congenital spinal canal stenosis (Kotil et al. 2007), achondroplasia (Laederich and Horton 2010; Benglis and Sandberg 2007)), muscles (muscular dystrophy) or neural tissues (syringohydromyelia). These also include combined multi system/organ disorders such as myelomenigocele (MMC) (Guille et al. 2006; Rajpal et al. 2007), malformations of the craniocervical junction (i.e. Arnold Chiari type, congenital stenosis, Klippel-Feil anomalies etc. ) (Fernandez et al. 2009; Nakamura et al. 2009; Pahys et al. 2009) or tethered cord (Kramer et al. 2009; Iskandar et al. 2001). Sometimes, these conditions are present in early childhood but only become
symptomatic during adolescence or advancing age. This may be due to progression or unmasking of the condition.

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW, Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 14:57:24.0 Medical History General Health History Participant History and Family History 4000

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C18146 HDL cholesterol value HDLCholstrlVal HDL cholesterol measured HDL cholesterol measured HDL cholesterol Numeric Values

Dyslipidemias may be worsened by a reduction in the serum HDL cholesterol value in those with acute or chronic SCI. Therefore, to have the ability to determine the effect of SCI per se on the lipid profile, this information, if available, should be provided (if several lipid profiles are available, the most recent values prior to SCI should be provided), along with the date obtained. The units of measurement to be used in this data set are mg/dL.

Bauman WA, Biering-S&Oslash;rensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Free-Form Entry

0 500 milligram per deciliter
C19215 Systemic neuro-degenerative disorder surgery caused indicator SysNeurDegenDisordSurgCausdInd Indicator for surgery caused by systemic neuro-degenerative disorder Indicator for surgery caused by systemic neuro-degenerative disorder Previous surgery due to this No;Yes No;Yes (if more than one repeat the information below) Alphanumeric

Systemic neuro-degenerative disorders comprise conditions like multiple sclerosis, amyotrophic lateral sclerosis and others. They typically occur in adults and are characterized by an acute or chronic progressive course, which can eventually present as tetra/paraplegia.

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW,<br />Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:52:41.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19161 Participant safety compromising medical condition indicator PrtcpntSftyComprmsngMedCondInd Indicator for serious co-morbid or concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient/participant or compromise the participant's ability to participate in the study Indicator for serious co-morbid or concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient/participant or compromise the participant's ability to participate in the study Does the participant have any other serious co-morbid or concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient/participant or compromise the participant's ability to participate in the study? No;Yes;Unknown No;Yes;Unknown Alphanumeric

Choose one. If this question is answered NO then the rest of the form is blank. If the question is answered YES then the medical history for at least one body system should be recorded

Adult;Pediatric Supplemental 1.00 2014-05-29 12:13:42.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00316 Medical history condition end date and time MedclHistCondEndDateTime Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history End Date Date or Date & Time

If the condition is not ongoing, record the date (and time) the medical condition/disease stopped. 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.) and in the format acceptable to the study database.

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

3145557
C19205 Congenital deformity surgery caused indicator CongentlDeformtySurgCausedInd Indicator for surgery caused by pre-existing congenital deformities of spine and spinal cord Indicator for surgery caused by pre-existing congenital deformities of spine and spinal cord Previous surgery due to this No;Yes No;Yes (if more than one repeat the information below) Alphanumeric

Congenital disorders include malformations or other pathology of bones (infantile idiopathic scoliosis (Dobbs et al. 2002; Pahys et al. 2009), congenital spinal canal stenosis (Kotil et al. 2007), achondroplasia (Laederich and Horton 2010; Benglis and Sandberg 2007)), muscles (muscular dystrophy) or neural tissues (syringohydromyelia). These also include combined multi system/organ disorders such as myelomenigocele (MMC) (Guille et al. 2006; Rajpal et al. 2007), malformations of the craniocervical junction (i.e. Arnold Chiari type, congenital stenosis, Klippel-Feil anomalies etc. ) (Fernandez et al. 2009; Nakamura et al. 2009; Pahys et al. 2009) or tethered cord (Kramer et al. 2009; Iskandar et al. 2001). Sometimes, these conditions are present in early childhood but only become
symptomatic during adolescence or advancing age. This may be due to progression or unmasking of the condition.

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW, Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:01:39.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C18147 LDL cholesterol value LDLCholestrlVal LDL cholesterol measured LDL cholesterol measured LDL cholesterol Numeric Values

Dyslipidemias may be worsened by a reduction in the serum HDL cholesterol value in those with acute or chronic SCI. Therefore, to have the ability to determine the effect of SCI per se on the lipid profile, this information, if available, should be provided (if several lipid profiles are available, the most recent values prior to SCI should be provided), along with the date obtained. The units of measurement to be used in this data set are mg/dL.

Bauman WA, Biering-S&Oslash;rensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Free-Form Entry

0 500 milligram per deciliter
C19216 Systemic neuro-degenerative disorder surgery caused description SysNeurDegnDsrdSurgCausdDesptn Description of surgery caused by systemic neuro-degenerative disorder Description of surgery caused by systemic neuro-degenerative disorder If previous surgery due to this, description Alphanumeric

Systemic neuro-degenerative disorders comprise conditions like multiple sclerosis, amyotrophic lateral sclerosis and others. They typically occur in adults and are characterized by an acute or chronic progressive course, which can eventually present as tetra/paraplegia.

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW,<br />Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:58:12.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C19171 Cardiac pacemaker last insertion date CardiacPacemkrLstInsertionDate Date at which cardiac pacemaker was last inserted Date at which cardiac pacemaker was last inserted Cardiac pacemaker, date last inserted 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.).

Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Exploratory 1.00 2014-05-29 14:20:49.0 Medical History General Health History Participant History and Family History

Free-Form Entry

C00317 Medical history condition start date and time MedclHistCondStrtDateTime Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Start Date Date or Date & Time

Record the date themedical condition/disease started. 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.) and in the format acceptable to the study database

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2543596
C19206 Congenital deformity surgery caused description CongentlDeformSurgCausdDescrip Description of surgery caused by pre-existing congenital deformities of spine and spinal cord Description of surgery caused by pre-existing congenital deformities of spine and spinal cord If previous surgery due to this, description Alphanumeric

Congenital disorders include malformations or other pathology of bones (infantile idiopathic scoliosis (Dobbs et al. 2002; Pahys et al. 2009), congenital spinal canal stenosis (Kotil et al. 2007), achondroplasia (Laederich and Horton 2010; Benglis and Sandberg 2007)), muscles (muscular dystrophy) or neural tissues (syringohydromyelia). These also include combined multi system/organ disorders such as myelomenigocele (MMC) (Guille et al. 2006; Rajpal et al. 2007), malformations of the craniocervical junction (i.e. Arnold Chiari type, congenital stenosis, Klippel-Feil anomalies etc. ) (Fernandez et al. 2009; Nakamura et al. 2009; Pahys et al. 2009) or tethered cord (Kramer et al. 2009; Iskandar et al. 2001). Sometimes, these conditions are present in early childhood but only become
symptomatic during adolescence or advancing age. This may be due to progression or unmasking of the condition.

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW, Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:10:34.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C18149 Lipid disorder specify name LipdDisordrSpecfyName Specifies the name of lipid disorder diagnosed Specifies the name of lipid disorder diagnosed Lipid disorder Specify diagnosis Alphanumeric

Dyslipidemias may be worsened by a reduction in the serum HDL cholesterol value in those with acute or chronic SCI. Therefore, to have the ability to determine the effect of SCI per se on the lipid profile, this information, if available, should be provided (if several lipid profiles are available, the most recent values prior to SCI should be provided), along with the date obtained. The units of measurement to be used in this data set are mg/dL.

Bauman WA, Biering-S&Oslash;rensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History 255

Free-Form Entry

C19217 Systemic neuro-degenerative disorder surgery date SystNeurDegenDisordSurgDate Date of surgery for systemic neuro-degenerative disorder Date of surgery for systemic neuro-degenerative disorder Date of surgery 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.).

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW, Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 16:01:57.0 Medical History General Health History Participant History and Family History

Free-Form Entry

C19174 Other cardiac disorder type OthrCardiacDisorderTyp Type of other cardiac disorder Type of other cardiac disorder Other cardiac disorders, specify Alphanumeric Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Exploratory 1.00 2014-05-30 14:25:23.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C00319 Medical history condition ongoing indicator MedclHistCondOngoingInd Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing Ongoing? Yes;No Yes;No Alphanumeric

Check Yes or No to indicate if the medical condition/disease is still present

Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2736881
C19207 Congenital deformity surgery date CongentlDeformtySurgeryDate The date of surgery on congenital deformity of spine and spinal cord The date of surgery on congenital deformity of spine and spinal cord Date of surgery 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.).

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW,<br />Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:14:06.0 Medical History General Health History Participant History and Family History

Free-Form Entry

C18151 Thyroid disease specify name ThyrdDiseasSpecfyName Specifies the name of thyroid disease diagnosed Specifies the name of thyroid disease diagnosed Specify diagnosis Alphanumeric

Having a spinal cord lesion does not protect against having other fairly prevalent endocrine abnormalities. Autoimmune thyroid dysfunction may be precipitated or made worse by an acute stressful event (Ladenson et al. 2000; Sonino et al. 1993).

Bauman WA, Biering-S&Oslash;rensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History 255

Free-Form Entry

C19282 Secondary death cause ICD-10-CM code SecondDeathCasueICD10Code ICD-10 code that describes the secondary cause of participant/subject's death ICD-10 code that describes the secondary cause of participant/subject's death Secondary cause(s) of death Alphanumeric

Record the ICD-10-CM code that corresponds to the secondary cause of death

Adult;Pediatric Supplemental 1.00 2014-06-06 10:52:23.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C19176 Pre spinal cord lesion cardiovascular history condition type PreSpnlCdLsnCardHistCondTyp Types of cardiovascular conditions present before spinal cord lesion Types of cardiovascular conditions present before spinal cord lesion Cardiovascular history before spinal cord lesion None;Cardiac surgery, specify;Other cardiac disorders, specify;Hypertension;Hypotension;Orthostatic hypotension;Deep vein thrombosis;Neuropathy (alcoholic, diabetic, and others);Myocardial infarction;Stroke;Family history of cardiovascular disease;Other, specify;Unknown;Cardiac pacemaker None;Cardiac surgery, specify;Other cardiac disorders, specify;Hypertension;Hypotension;Orthostatic hypotension;Deep vein thrombosis;Neuropathy (alcoholic, diabetic, and others);Myocardial infarction;Stroke;Family history of cardiovascular disease;Other, specify;Unknown;Cardiac pacemaker Alphanumeric

These codes include conditions present prior to the spinal cord lesion, which may influence the outcomes related to the cardiovascular functions. Altered autonomic control routinely leads to instability of blood pressure following spinal cord lesions. Hypotension is common in acute and chronic spinal cord lesions. In addition, intermittent hypertension can be associated with noxious or non-noxious stimuli and resultant autonomic dysreflexia. Preexisting abnormalities of blood pressure can influence these changes.
Hypertension: (arterial blood pressure >140/90 mmHg).
Hypotension: (systolic arterial blood pressure Orthostatic hypotension: Symptomatic or asymptomatic decrease in blood pressure usually exceeding 20 mmHg systolic or 10 mmHg diastolic on moving from the supine to an upright position.
Deep vein thrombosis: Thrombosis of the deep veins of the legs, pelvis or arms, due to coagulopathy, stasis, or endothelial injury.
Pre-existing neuropathies (e.g. diabetic or alcoholic neuropathy) and other conditions associated with autonomic dysfunctions (e.g. Parkinson's disease, multiple sclerosis, traumatic brain injury) can affect altered cardiovascular functions post spinal cord lesion, and should therefore be included.

Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Exploratory 1.00 2014-05-30 14:56:50.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00322 Medical history condition text MedclHistCondTxt Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history Medical history term Alphanumeric

Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus of this study. Use only one line per description.

Make sure to record if the following events are in the medical history which are Core items: Any stroke; Ischemic stroke; Hemorrhagic stroke; Hemorrhagic stroke type; 4) Transient ischemic attack (TIA); Carotid stenosis; Epilepsy/ Seizure disorder; Central nervous system infection; Dementia; Head trauma; Head trauma type; Atrial fibrillation (AF)/ flutter; Rheumatic heart disease

SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

2003874
C19208 Pre-existing degenerative spine disorders specify diagnosis name DgnrtvSpinDisordSpcfyDiagName Specifies name of pre-existing degenerative spine disorder Specifies name of pre-existing degenerative spine disorder Specify diagnosis Alphanumeric

Degenerative spine disorders present with aging. The most common disorders are lumbar (Abbas et al. 2010; Yasar et al. 2009) and cervical (Tracy & Bartleson 2010; Fehlings & Arvin 2009) spinal canal stenosis, spondylosis and degenerative systemic disorders (like diffuse idiopathic skeletal hyperostosis (DISH) and rheumatoid arthritis). These disorders typically develop slowly with the spinal cord often adapting to extensive morphological changes before notable
impairment. The onset of impairments is usually slow and insidious and therefore not noticed by individuals for a considerable time. However, the degenerative changes can increase susceptibility to spinal cord lesions from relatively minor insults, e.g. minor falls with mild extension/flexion trauma inducing a central cord syndrome (Matz et al. 2009).

Biering-S&Oslash;rensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW,<br />Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic<br />data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 1.00 2014-06-03 15:18:46.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C18153 Data unknown text DataUnknwnTxt The free-text field to Mark an "X" in to record if data are unknown or not available. The free-text field to Mark an "X" in to record if data are unknown or not available. Or data. Date of surgery unknown Alphanumeric Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History 20

Free-Form Entry

C19348 Cardiovascular history other text CardVascHistOTH The free-text field related to "Cardiovascular history condition type" specifying other text. The free-text field related to "Cardiovascular history condition type" specifying other text. Other, specify Alphanumeric Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Exploratory 1.00 2014-06-12 09:08:09.0 Medical History General Health History Participant History and Family History 255

Free-Form Entry

C19177 Pre spinal cord lesion pulmonary conditions present type PreSpnlCrdLesionPulmnyCondTyp Types of pulmonary conditions present before spinal cord lesion Types of pulmonary conditions present before spinal cord lesion Pulmonary conditions present before the spinal cord lesion None;Asthma;Sleep apnea;Unknown;Chronic obstructive pulmonary disease;Other, specify None;Asthma;Sleep apnea;Unknown;Chronic obstructive pulmonary disease (including emphysema and chronic bronchitis);Other, specify Alphanumeric

These codes include pulmonary conditions diagnosed prior to the spinal cord lesion that may negatively impact pulmonary function. Asthma and COPD are relatively common conditions associated with airflow obstruction. If the information has been documented once it is not necessary to fill in this variable again, to avoid redundant data.

Biering-S&Oslash;rensen F, Krassioukov A, Alexander MS, Donovan W, Karlsson AK, Mueller G, Perkash I, William Sheel A, Wecht J, Schilero GJ.International Spinal Cord Injury Pulmonary Function Basic Data Set. Spinal Cord. 2012 Jun; 50(6):418-21. Adult;Pediatric Exploratory 1.00 2014-05-30 14:58:45.0 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C04802 Death date and time DeathDateTime Date (and time, if known) of participant's/subject's death Date (and time, if known) of participant's/subject's death Date of Death (and time) Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2004152
CSV