CDE Detailed Report
Subdomain Name: General Health History
CRF: welcome
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 / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
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C18147 | Laboratory procedure LDL cholesterol measurement | LabProcedLDLCholesterolMeasr | Measurement of the amount of low density lipoprotein (LDL) cholesterol in the participant's blood | Measurement of the amount of low density lipoprotein (LDL) cholesterol in the participant's blood | 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-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 | 4.00 | 2024-02-29 15:53:42.0 | 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-SØrensen 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 |
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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-SØrensen 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 |
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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 medical history | Date (and time, if applicable and known) for the start of an event in the participant'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 | 3.10 | 2024-02-29 15:42:43.0 | 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 |
Biering-SØrensen 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 |
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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-SØrensen 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 |
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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-SØrensen 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 |
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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-SØrensen 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 |
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C00319 | Medical history condition ongoing indicator | MedclHistCondOngoingInd | Indicator of whether a medical condition/disease experienced by the participant is ongoing | Indicator of whether a medical condition/disease experienced by the participant 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 | 4.00 | 2024-02-29 15:42:44.0 | 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-SØrensen 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 |
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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-SØrensen 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 |
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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 |
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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. |
Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen 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 |
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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 |
Biering-SØrensen 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 |
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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 availabl | 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 |
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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 tex | Other, specify | Alphanumeric | Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen 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 |
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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-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 14:58:45.0 | Medical History | General Health History | Participant History and Family History |
Multiple Pre-Defined Values Selected |
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C04802 | Death date and time | DeathDateTime | Date (and time, if known) of participant's death | Date (and time, if known) of participant's death | Date of Death (and time) | Date or Date & Time | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:24 AM | Medical History | General Health History | Participant History and Family History |
Free-Form Entry |
2004152 | |||||||||||
C19209 | Pre-existing degenerative spine disorder specify anatomic site | DgnrtvSpinDisordSpcfyAntmcSite | Specifies anatomic site of pre-existing degenerative spine disorder | Specifies anatomic site of pre-existing degenerative spine disorder | Specify location | 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 |
Biering-SØrensen 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 15:23:28.0 | Medical History | General Health History | Participant History and Family History | 4000 |
Free-Form Entry |
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C18168 | Laboratory procedure total cholesterol measurement | LabProcedTotalCholesterolMeasr | Measurement of the total amount of cholesterol in the participant's blood | Measurement of the total amount of cholesterol in the participant's blood | 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 | 4.00 | 2024-02-29 15:53:43.0 | 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's death | ICD-10-CM code that describes the cause of participant'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 | 3.1 | 10/16/2024 8:50:26 AM | Medical History | General Health History | Participant History and Family History | 255 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
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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 |
Biering-SØrensen 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 |
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C18169 | Laboratory procedure triglycerides measurement | LabProcedTriglyceridesMeasr | Measurement of the amount of triglycerides in the participant's blood | Measurement of the amount of triglycerides in the participant's blood | 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-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 | 4.00 | 2024-02-29 15:53:45.0 | Medical History | General Health History | Participant History and Family History |
Free-Form Entry |
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-SØrensen 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 |
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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 SC | 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 |
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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 |
Biering-SØrensen 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 |
Free-Form Entry |
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C18678 | Family history medical condition type other text | FamHistMedclCondTypOTH | 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-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. | Adult;Pediatric | Exploratory | 1.10 | 2024-02-29 15:42:35.0 | 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-SØrensen 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 |
Free-Form Entry |
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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 |
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. 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 | 4.00 | 2024-02-29 15:41:20.0 | Medical History | General Health History | Participant History and Family History |
Single Pre-Defined Value Selected |
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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-SØrensen 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 |
Free-Form Entry |
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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 lesio | If yes, specify | Alphanumeric | 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 | 4000 |
Free-Form Entry |
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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 system | 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-SØrensen 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 |
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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 |
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-SØrensen 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 |
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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-SØrensen 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 |
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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 SC | 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 |
Free-Form Entry |
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C00314 | Medical history taken date and time | MedclHistTakenDateTime | Date (and time, if applicable and known) the participant's medical history was taken | Date (and time, if applicable and known) the participant '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 | 3.20 | 2024-02-29 15:42:39.0 | 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 |
Biering-SØrensen 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 |
Free-Form Entry |
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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-SØrensen 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 |
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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-SØrensen 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 |
Free-Form Entry |
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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-SØrensen 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 |
Free-Form Entry |
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C00315 | Medical history global assessment indicator | MedclHistGlobalAssmtInd | Indicator of whether the participant has a history of any medical problems/conditions | Indicator of whether the participant 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 | 3.10 | 2024-02-29 15:42:39.0 | 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 |
Biering-SØrensen 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 |
Free-Form Entry |
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C18146 | Laboratory procedure HDL cholesterol measurement | LabProcedHDLCholesterolMeasr | Measurement of the amount of high density lipoprotein (HDL) cholesterol in the participant's blood | Measurement of the amount of high density lipoprotein (HDL) cholesterol in the participant's blood | 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-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 | 4.00 | 2024-02-29 15:53:42.0 | 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-SØrensen 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 |
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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 |
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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 medical history | Date (and time, if applicable and known) for the end of an event in the participant'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 | 3.10 | 2024-02-29 15:42:44.0 | Medical History | General Health History | Participant History and Family History |
Free-Form Entry |
3145557 |