CDE Detailed Report

Disease: system
Subdomain Name: Physical Examinations
CRF: files

Displaying 1 - 50 of 126
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
C06216 Abdominal pain discomfort frequency AbdmnlPainDiscfrtFreq The frequency of abdominal pain/discomfort within the last three months. The frequency of abdominal pain/discomfort within the last three months. Abdominal pain/discomfort (within the last three months): Daily;Not every day but at least once per week;Not every week but at least once per month;Less than once per month;Never;Not applicable;Unknown Daily;Not every day but at least once per week;Not every week but at least once per month;Less than once per month;Never;Not applicable;Unknown Alphanumeric

Choose one. Abdominal pain or discomfort is a common symptom in individuals with SCI but also in chronic constipation or irritable bowel syndrome. It should be documented separately from abdominal bloating and perianal symptoms covered by those specific variables. In some individuals abdominal pain is an indirect signal of the need to defecate. In such cases it is covered both by that specific variable in the Bowel Function Basic SCI Data Set and here. In subjects unable to feel abdominal pain the term "Never" should be used.

Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06403 Hyperthermia past three months status HyperthrmPstThreeMoStatus Status of whether the subject had hyperthermia after spinal cord lesion within the last three months. Hyperthermia is defined as rectal temperature above 38.4 degrees Celsius Status of whether the subject had hyperthermia after spinal cord lesion within the last three months. Hyperthermia is defined as rectal temperature above 38.4 degrees Celsiu Thermoregulation history after spinal cord lesion within the last three months Hyperthermia Non infectious;Infectious;Unknown Non infectious;Infectious;Unknown Alphanumeric

Choose one

Karlsson AK, Krassioukov A, Alexander MS, Donovan W, Biering-SØrensen F. International spinal cord injury skin and thermoregulation function basic data set. Spinal Cord. 2012 Jul;50(7):512-6. doi: 10.1038/sc.2011.167. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C18783 Pulmonary condition after spinal cord lesion last year other text PulmnCndAftrSpnlCrdLsnLstYrOTH The free-text field related to 'Pulmonary condition after spinal cord lesion last year type' specifying other text. Type of pulmonary complication or condition that may have occurred after the spinal cord lesion (within the last year) The free-text field related to 'Pulmonary condition after spinal cord lesion last year type' specifying other text. Type of pulmonary complication or condition that may have occurred after the spinal cord lesion (within the last year) Other, specify Alphanumeric

For each pulmonary complication or condition indicate if occurred within the last year.

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 Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

C06236 Stool defecation assistance past three months average duration StlDefctnAsstncPstThrMoAvgDur The average time duration in minutes during bowel movement that stool intermittently or continuously (in the case of a single defecation) comes out with or without assistance within the last three months The average time duration in minutes during bowel movement that stool intermittently or continuously (in the case of a single defecation) comes out with or without assistance within the last three months. Events and intervals of defecation (2): Average time during bowel movement that stool intermittently or continuously comes out with or without assistance (within the
last three months):
Numeric Values

Record in time duration in minutes based on each individual's own assessment of time consumption. This element begins at the end of the previous element (Bowel care initiation to stool comes out past three months average duration).

House JG, Stiens SA. Pharmacologically initiated defecation for persons with spinal cord injury: effectiveness of three agents. Arch Phys Med Rehabil 1997; 78: 1062-1065. Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Free-Form Entry

minute
C06431 Spinal injury traumatic translation indicator SpnlInjTraumtcTransltnInd For each of the spinal column injury level(s) whether there was any traumatic translation (occiput to sacrum). Translation is defined as sagittal and/or coronal plane mal-alignment of adjacent vertebra as seen on lateral and/or AP radiographs respectively; it consists of movement of 3.5 mm or more of one cervical vertebra on top of the adjacent vertebra or movement of 2.5 mm or more of one thoracic and lumbar vertebra on top of the adjacent vertebra1 (on available imaging) For each of the spinal column injury level(s) whether there was any traumatic translation (occiput to sacrum). Translation is defined as sagittal and/or coronal plane mal-alignment of adjacent vertebra as seen on lateral and/or AP radiographs respectively; it consists of movement of 3.5 mm or more of one cervical vertebra on top of the adjacent vertebra or movement of 2.5 mm or more of one thoracic and lumbar vertebra on top of the adjacent vertebra1 (on available imaging Traumatic translation No;Yes;Unknown No;Yes;Unknown Alphanumeric

Choose one - This is to be filled in for each level of injury, starting with the most cephalic injury. Malalignment that was caused by a degenerative process such as degenerative spondylolisthesis is not considered traumatic translation, and the value "No" should be recorded. In the case of multiple spinal injuries, a separate entry will be filled out regarding each level.
Translation will be defined as sagittal and/or coronal plane malalignment of adjacent vertebra as seen on lateral and/or AP radiographs respectively; it consists of movement of 3.5 mm or more of one cervical vertebra on top of the adjacent vertebra or movement of 2.5 mm or more of one thoracic and lumbar vertebra on top of the adjacent vertebra (on available imaging). Malalignment that was caused by a degenerative process such as degenerative spondylolisthesis is not considered traumatic translation, and the value "0" (No) should be recorded. In the case of multiple spinal injuries, a separate entry will be filled out regarding each level.

Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International Spinal Cord Injury Spinal Column Injury Basic Data Set. Spinal Cord. 2012 Nov;50(11):817-821; doi: 10.1038/sc.2012.60. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06021 Urinary incontinence collect appliance type UrinInconColApplTyp Type or types of collecting appliances for urinary incontinence. Collecting appliances are any externally applied aids to avoid urinary leakage, or devices for collection of urine Type or types of collecting appliances for urinary incontinence. Collecting appliances are any externally applied aids to avoid urinary leakage, or devices for collection of urin If yes, indicate appliance for urinary incontinence Condom catheter/sheath;Diaper;Ostomy bag;Other,specify Condom catheter/sheath;Diaper;Ostomy bag;Other, specify Alphanumeric

Regular use of one or more collecting appliances is to be recorded. For each collecting appliance type indicate if it is used. Individuals with spinal cord lesions that use such appliances less than once a month, "for the sake of safety", and who have no more than exceptional episodes of leakage during a year should be excluded (adapted from Levi and Ertzgaard 1998). For other possible collecting appliances it is recommended to write them in a textfield, from which it will be possible to retrieve more detailed data when necessary.

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. Levi R, Ertzgaard P, The Swedish Spinal Cord Injury Council 1998. Quality indicators in spinal cord injury care: A Swedish collaboration project. Scand J Rehabil Med 1998;Suppl.38:1-80. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Multiple Pre-Defined Values Selected

C18908 Diagnosis stroke risk factor new other text DiagnosStrokeRiskFactorNewOTH The free-text field related to 'Diagnosis new type' specifying other text. If there were any new diagnoses related to stroke risk factors during hospital stay, describes those risk factors The free-text field related to 'Diagnosis new type' specifying other text. If there were any new diagnoses related to stroke risk factors during hospital stay, describes those risk factor New diagnosis, describe Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

C21617 Stool defecation assistance past three month average indicator StlDefctnAstncPstThrMoAvgInd The indicator related to the average time duration in minutes during bowel movement that stool intermittently or continuously (in the case of a single defecation) comes out with or without assistance within the last three months The indicator related to the average time duration in minutes during bowel movement that stool intermittently or continuously (in the case of a single defecation) comes out with or without assistance within the last three month Events and intervals of defecation (2): Average time during bowel movement that stool intermittently or continuously comes out with or without assistance (within the
last three months):
Not applicable;Unknown Not applicable;Unknown Alphanumeric

Record in time duration in minutes based on each individual's own assessment of time consumption. This element begins at the end of the previous element (Bowel care initiation to stool comes out past three months average duration).

House JG, Stiens SA. Pharmacologically initiated defecation for persons with spinal cord injury: effectiveness of three agents. Arch Phys Med Rehabil 1997; 78: 1062-1065. Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06313 Psychogenic genital arousal scale PsychogenicGentialArousalScale Scale for how the female participant's psychogenic genital arousal is affected by the spinal cord injury Scale for how the female participant's psychogenic genital arousal is affected by the spinal cord injur Psychogenic Genital Arousal Normal;Reduced/altered;Absent;Unknown;Not applicable (Patient female) Includes reports of no change in time to achieve lubrication, amount of lubrication or duration of lubrication subsequent to the spinal cord lesion;Includes reports of either altered time (longer or shorter) to achieve, amount of lubrication, or duration of lubrication. It would also include reports of excessive psychogenic lubrication;Refers to women having no lubrication despite being psychologically aroused;Refers to reports by individuals that they have not been sexually active thus do not know if they are able to achieve psychogenic genital arousal after the spinal cord lesion; Alphanumeric

Choose one. When querying individuals about psychogenic arousal it is recommended that the interviewer focus on the woman's awareness of vaginal lubrication as opposed to clitoral engorgement.

Alexander MS, Biering-SØrensen F, Elliott S, Kreuter M, SØnksen J. International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set. Spinal Cord. 2011 Jul;49(7):787-90. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C17414 Urinary tract infection symptom type UTISymptmTyp Type of sign(s)/symptom(s) associated with a bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethra Type of sign(s)/symptom(s) associated with a bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethr Sign(s)/symptom(s) (select all that apply): Fever;Incontinence, onset or increase in episodes, including leaking around catheter;Spasticity, increased;Malaise, lethargy or sense of unease;Cloudy urine (with or without mucus or sediment) with increased odor;Pyuria;Discomfort or pain over the kidney or bladder or during micturition;Autonomic dysreflexia;Other Fever;Incontinence, onset or increase in episodes, including leaking around catheter;Spasticity, increased;Malaise, lethargy or sense of unease;Cloudy urine (with or without mucus or sediment) with increased odor;Pyuria;Discomfort or pain over the kidney or bladder or during micturition;Autonomic dysreflexia;Other Alphanumeric

Symptoms are subjective reports given to the examiner. Signs are objective physical findings of the examiner. Individuals with spinal cord lesions may have many of the above signs and symptoms due to their spinal cord lesion or other
problems. Therefore, it is important to determine that an individual's symptoms are of a new onset or have increased and are not chronic in nature from a preexisting or intercurrent problem. Many signs and symptoms do not constitute
justification for treatment. A UTI is characterized by the new onset of symptoms accompanied with laboratory findings (bacteriuria, leukocyturia and positive urine culture) of a UTI (National Institute on Disability and Rehabilitation
Research criteria for UTI, 1992). For the purposes of the International SCI UTI Basic Data Set only the signs and symptoms indicated above were chosen. Massa and colleagues (2009) found that cloudy urine had the highest accuracy (83.1%), and leukocytes in the urine had the highest sensitivity (82.8%) for the presence of UTI. Fever had very high specificity (99%) but very low sensitivity (6.9%). Autonomic dysreflexia data had low numbers and should be interpreted
with caution. Kidney/bladder discomfort, increased spasticity, feeling sick, sense of unease, increased need to perform catheterization, feeling tired, incontinence, and foul smelling urine all had high sensitivity (77-95%) but very low specificity
(less than 50%).

Goetz LL, Cardenas DD, Kennelly M, Bonne Lee BS, Linsenmeyer T, Moser C, Pannek J, Wyndaele JJ, Biering-Sorensen F. International spinal cord injury urinary tract infection basic data set. Spinal Cord. 2013 Sep;51(9):700-4. doi: 10.1038/sc.2013.72. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06191 Defecation past four week average frequency DefctnPstFourWkAvgDurFreq Average frequency of defecation within the last four weeks Average frequency of defecation within the last four week Frequency of defecation (within the last four weeks): Unknown;Daily;2-6 times per week;Once every week or less Unknown;Daily;2-6 times per week;Once every week or less Alphanumeric

Choose one.
This element does not distinguish between spontaneous or assisted defecation. Not applicable can be used i.e. in subjects with ileo- or colostomy.
The frequency of defecation is very variable. However, in the general population more than 94% defecate between three times per day and three times per week (Drossman et al. 1982). Among individuals with SCI approximately 3% defecate less than once every week. Extremely few individuals will not have defecated within the last four weeks. However, in order to be able to compute the Cleveland Constipation Score this option is included. Infrequent defecation is an indicator of insufficient bowel management and associated with impact on quality of life (Krogh et al. 2006).

Drossman DA, Sandler RS, McKee DC, Lovitz AJ. Bowel patterns among subjects not seeking health care. Gastroenterology 1982; 83: 529-534. Krogh K, Christensen P, Sabroe S, Laurberg S. Neurogenic bowel dysfunction score. Spinal Cord 2006; 44: 625. Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06217 Respiratory discomfort distended abdomen frequency ResprtyDiscfrtDistndAbdmnFreq The frequency of any respiratory discomfort (shortness of breath/difficulty in taking a deep breath) considered to be entirely or partly due to a distended abdomen within the last three months. The frequency of any respiratory discomfort (shortness of breath/difficulty in taking a deep breath) considered to be entirely or partly due to a distended abdomen within the last three months. Any respiratory discomfort (shortness of breath/difficulty in taking a deep breath) considered to be entirely or partly due to a distended abdomen (within the last three months): Daily;Not every day but at least once per week;Not every week but at least once per month;Less than once per month;Never;Not applicable;Unknown Daily;Not every day but at least once per week;Not every week but at least once per month;Less than once per month;Never;Not applicable;Unknown Alphanumeric

Choose one. Respiratory symptoms entirely due to higher level SCI should not be included in this element.

Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06404 Hypothermia past three months status HypothrmPstThreeMoStatus Status of whether the subject had hypothermia after spinal cord lesion within the last three months. Hypothermia is defined as rectal temperature below 35 degrees Celsius Status of whether the subject had hypothermia after spinal cord lesion within the last three months. Hypothermia is defined as rectal temperature below 35 degrees Celsiu Thermoregulation history after spinal cord lesion within the last three months Hypothermia Non infectious;Infectious;Unknown Non infectious;Infectious;Unknown Alphanumeric

Choose one

Karlsson AK, Krassioukov A, Alexander MS, Donovan W, Biering-SØrensen F. International spinal cord injury skin and thermoregulation function basic data set. Spinal Cord. 2012 Jul;50(7):512-6. doi: 10.1038/sc.2011.167. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C18784 Ventilatory assistance other text VentiltryAsstOTH The free-text field related to 'Ventilatory assistance type' specifying other text. Type of assistance device utilized to augment ventilation The free-text field related to 'Ventilatory assistance type' specifying other text. Type of assistance device utilized to augment ventilation Other, specify Alphanumeric

Record any assistance device utilized at the time of evaluation to augment ventilation. For each device indicate if it was utilized at the time of evaluation.

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 Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

C06237 Bowel care time stool pass care past three months average duration BwlCrTmStlPssCrPstThrMoAvgDur The average time duration spent waiting after last stool passes before ending bowel care within the last three months. The average time duration spent waiting after last stool passes before ending bowel care within the last three months. Events and intervals of defecation (3): Average time spent waiting after last stool passes before ending bowel care (within the last three months): Numeric Values

Record in time duration in minutes based on each individual's own assessment of time consumption. This element begins at the end of the previous element (Stool intermittent or continuous defecation with or without assistance past three months average duration).

House JG, Stiens SA. Pharmacologically initiated defecation for persons with spinal cord injury: effectiveness of three agents. Arch Phys Med Rehabil 1997; 78: 1062-1065. Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Free-Form Entry

minute
C06435 Neuro-Musculoskeletal condition type NeuroMuscskltlCondTyp Type of neuro-musculoskeletal condition experienced or diagnosed Type of neuro-musculoskeletal condition experienced or diagnosed Fractures, heterotopic ossifications, contractures, or degenerative changes/overuse Fracture;Heterotopic ossification;Contracture;Degenerative change/overuse Fracture;Heterotopic ossification;Contracture;Degenerative change/overuse Alphanumeric

Identifies whether the anatomic site and laterality type describes the fracture, heterotopic ossification, contracture, or degenerative change/overuse

Biering-SØrensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW, Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic data set. Spinal Cord. 2012 Nov;50(11):797-802; doi: 10.1038/sc.2012.102. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06054 Urinary symptom change past year indicator UrinSympChngPstYrInd Indicator of whether there were any change in urinary symptoms within the last year Indicator of whether there were any change in urinary symptoms within the last year Any change in urinary symptoms within the last year No;Yes;Not applicable;Unknown No;Yes;Not applicable;Unknown Alphanumeric

Lower urinary tract symptoms are according to the International Continence Society the subjective indicator of a disease or change in conditions as perceived by the individual with spinal cord lesion, attendant or partner and may lead him/her to seek help from health care professionals (Abrams et al. 2002). Symptoms may either be volunteered or described during the data collection interview with the individual with spinal cord lesion. The information may be qualitative as well as quantitative, e.g. change in frequency, urgency, nocturia, incontinence, hesitancy, slow stream, etc. "Not applicable" is to be used when data reporting is performed within the first year after the spinal cord lesion.

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardization of Terminology of Lower Urinary Tract Function: Report from the Standardization Sub-committee of the International Continence Society. 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 Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C19091 Urinary tract surgical procedure indicator UrinaryTractSurgProcedInd Indicator for surgical procedure on the urinary tract Indicator for surgical procedure on the urinary tract Surgical procedures on the urinary tract: No;Yes;Unknown No;Yes;Unknown Alphanumeric

Bladder stone or upper urinary tract stone removal includes any type of removal, including via endoscopy, extracorporal shock wave lithotripsy (ESWL), or open lithotomy.
The ileoureterostomy is corresponding to the formely ileal loop or ureteroileocutaneostomy (Bricker conduit). The continent catheterizable valves, include Monteand Mitrofanoff procedures.
For other possible surgical procedures it is recommended to write them in a textfield, from which it will be possible to retrieve more detailed data when necessary. If there is more than one "other" surgical procedure, this field may be duplicated or triplicated, with the latest date given when the particular procedure has been performed. If the information has been documented once and noadditional surgical procedures on the urinary tract have been performed it is not necessary fill in this item again, 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 Supplemental 1.00 2014-05-27 15:00:45.0 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C21618 Bowel care time stool pass care past three month average indicator BwlCrTmStlPsCrPstThrMoAvgInd The indicator related to average time duration spent waiting after last stool passes before ending bowel care within the last three months The indicator related to average time duration spent waiting after last stool passes before ending bowel care within the last three month Events and intervals of defecation (3): Average time spent waiting after last stool passes before ending bowel care (within the last three months): Not applicable;Unknown Not applicable;Unknown Alphanumeric

Record in time duration in minutes based on each individual's own assessment of time consumption. This element begins at the end of the previous element (Stool intermittent or continuous defecation with or without assistance past three months average duration).

House JG, Stiens SA. Pharmacologically initiated defecation for persons with spinal cord injury: effectiveness of three agents. Arch Phys Med Rehabil 1997; 78: 1062-1065. Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06314 Reflex genital arousal scale ReflexGenitalArousalScale Scale for how the female's reflex genital arousal is affected by the spinal cord injury Scale for how the female's reflex genital arousal is affected by the spinal cord injur Relfex Genital Arousal Normal;Reduced/altered;Absent;Unknown;Not applicable (Patient male) No change in time to achieve lubrication, amount of lubrication or duration of lubrication with genital stimulation subsequent to the spinal cord lesion;Includes reports of either altered time (longer or shorter) to achieve, amount of lubrication, or duration of lubrication. It would also include reports of excessive reflex lubrication. Absent refers to individuals having no awareness of lubrication despite being genitally stimulated;Reflex arousal is thought to only to happen in the presence of complete cauda equina or conus lesion;Refers to reports by individuals that they have not been sexually active thus they do not know if they are able to achieve reflex arousal after the spinal cord lesion; Alphanumeric

Choose one. When querying individuals about reflex arousal it is recommended that the interviewer focus on the woman's awareness of vaginal lubrication as opposed to clitoral engorgement.

Alexander MS, Biering-SØrensen F, Elliott S, Kreuter M, SØnksen J. International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set. Spinal Cord. 2011 Jul;49(7):787-90. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C17416 Urinary tract infection symptom other text UTISymptmOthrTxt Text field to specify a symptom (other than those pre-defined) associated with a bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethra Text field to specify a symptom (other than those pre-defined) associated with a bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethr Other, specify Alphanumeric Goetz LL, Cardenas DD, Kennelly M, Bonne Lee BS, Linsenmeyer T, Moser C, Pannek J, Wyndaele JJ, Biering-Sorensen F. International spinal cord injury urinary tract infection basic data set. Spinal Cord. 2013 Sep;51(9):700-4. doi: 10.1038/sc.2013.72. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations 255

Free-Form Entry

C06193 Diaper pad plug use past four week indicator DiapPadPlugPstFourWkInd Indicator for need to wear a diaper, pad or plug within the last four weeks Indicator for need to wear a diaper, pad or plug within the last four weeks Need to wear diaper, pad or plug No;Yes;Unknown No;Yes;Unknown Alphanumeric

Within the last four weeks, choose one. The need to wear a pad only for urinary incontinence should not be included.

Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06218 Perianal pain defecation frequency PernlPainDefctnFreq The frequency of any perianal pain during defecation within the last three months The frequency of any perianal pain during defecation within the last three month Perianal pain during defecation (within the last three months): Daily;Not every day but at least once per week;Not every week but at least once per month;Less than once per month;Never;Not applicable;Unknown Daily;Not every day but at least once per week;Not every week but at least once per month;Less than once per month;Never;Not applicable;Unknown Alphanumeric

Choose one. Most individuals with complete SCI are unable to feel perianal pain during defecation. In such cases the code "Never" and not the code "Unknown" should be used. Indirect indicators of perianal pain during defecation such as perspiration, spasms or headache are not registered here. The code "Not applicable" is mainly for individuals with stomas.

Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06405 Hyperhidrosis past three months status HyprhdrPstThreeMoStatus Status of whether the subject had hyperhidrosis after spinal cord lesion within the last three months. Hyperhidrosis is defined as excessive sweating above or below level of injury in the absence of increased ambient temperature Status of whether the subject had hyperhidrosis after spinal cord lesion within the last three months. Hyperhidrosis is defined as excessive sweating above or below level of injury in the absence of increased ambient temperatur Thermoregulation history after spinal cord lesion within the last three months Hyperhidrosis Above lesion;Below lesion;Unknown Above lesion;Below lesion;Unknown Alphanumeric

Choose one

Karlsson AK, Krassioukov A, Alexander MS, Donovan W, Biering-SØrensen F. International spinal cord injury skin and thermoregulation function basic data set. Spinal Cord. 2012 Jul;50(7):512-6. doi: 10.1038/sc.2011.167. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C00313 Medical history condition SNOMED CT code MedclHistCondSNOMEDCTCode Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject If YES, new diagnosis (indicate SNOMED term and code), describe Alphanumeric

Code each of the new diagnoses made using SNOMED CT.

Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Clinical Assessment Physical Examinations Assessments and Examinations 255

Free-Form Entry

C18786 Defecation method bowel care procedure used past four week main other text DefctnMthdBwlProcedUseMainOTH The free-text field related to 'Defecation method bowel care procedure used past four week main type' specifying other text. Type of main defecation method and bowel care procedures used within the last four weeks The free-text field related to 'Defecation method bowel care procedure used past four week main type' specifying other text. Type of main defecation method and bowel care procedures used within the last four week Other, specify Alphanumeric Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

C06238 Anal incontinence lifestyle alteration past three months scale AnlInctncLifstylAltPstThrMoScl The scale that assesses lifestyle alteration due to anal incontinence within the last three months. The scale that assesses lifestyle alteration due to anal incontinence within the last three months. Lifestyle alteration due to anal incontinence (within the last three months): Lifestyle altered each day;Lifestyle altered at least once per week but not every day;Lifestyle altered more than once per month but not every week;Lifestyle altered once per month;Lifestyle altered less than once per month;Lifestyle not altered;Not applicable;Unknown Lifestyle altered each day;Lifestyle altered at least once per week but not every day;Lifestyle altered more than once per month but not every week;Lifestyle altered once per month;Lifestyle altered less than once per month;Lifestyle not altered;Not applicable;Unknown Alphanumeric

Choose one. This variable only covers altered lifestyle due to anal incontinence or the risk of anal incontinence. Examples may by avoidance of social activities, traveling, sexual activities etc. The code "Not applicable" is mainly for individuals with stomas.

Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06436 Neuro-Musculoskeletal condition anatomic site NeuroMuscskltlCondAntmicSite Anatomic site of the neuro-musculoskeletal condition experienced or diagnosed Anatomic site of the neuro-musculoskeletal condition experienced or diagnosed Location Neck/Cervical spine;Shoulder/Humerus;Elbow;Forearm;Wrist;Hand;Upper back/Thoracic spine;Lower back/Lumbar spine;Pelvis;Hip/Femur;Knee;Tibia/Fibula;Ankle;Foot Neck/Cervical spine;Shoulder/Humerus;Elbow;Forearm;Wrist;Hand;Upper back/Thoracic spine;Lower back/Lumbar spine;Pelvis;Hip/Femur;Knee;Tibia/Fibula;Ankle;Foot Alphanumeric

Choose one for each neuro-musculoskeletal condition (fracture, heterotopic ossification, contracture, or degenerative change/overuse)

Fergusson D, Hutton B and Drodge A. The epidemiology of major joint contractures: A systematic review of the literature. Clinical Orthopaedics and Related Research. 2006;14:22-29. Apple, D, Cody, R, Allen, A. Overuse Syndrome of the Upper Limb in People With Spinal Cord Injury. In: Apple, DF, Editor, Physical Fitness: A guide for individuals with spinal cord injury. Journal of Rehabilitation Research and Development, Chapter 5, 1996 (Clinical Supplement): 97-108<br />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 data set. Spinal Cord. 2012 Nov;50(11):797-802; doi: 10.1038/sc.2012.102. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06109 Pulmonary condition after spinal cord lesion last year type PulmnCndAftrSpnlCrdLsnLstYrTyp Type of pulmonary complication or condition that may have occurred after the spinal cord lesion (within the last year) Type of pulmonary complication or condition that may have occurred after the spinal cord lesion (within the last year) Pulmonary complications and conditions after the spinal cord lesion within last year Pneumonia;Chronic obstructive pulmonary disease;Sleep apnea;Other, specify;Unknown;None Pneumonia;Chronic obstructive pulmonary disease (including emphysema and chronic bronchitis);Sleep apnea;Other, specify;Unknown;None Alphanumeric

For each pulmonary complication or condition indicate if occurred within the last year.
Pneumonia is one of the leading causes of mortality in individuals with spinal cord lesions (Hartkopp et al. 1997; DeVivo et al. 1999; Lidal et al. 2007), therefore it is important to record this information in detail and whenever possible. Other respiratory complications and conditions may develop after sustaining a spinal cord lesion, including atelectasis (lung collapse), and other disorders with high disease prevalence in the general population (i.e. asthma, COPD). Sleep apnea, either obstructive or central in etiology, is a common yet frequently unrecognized condition among individuals with spinal cord lesions (Leduc et al. 2007; Berlowitz et al. 2005). Sleep apnea may adversely affect sleep quality and daytime functioning, and studies in the general population suggest that obstructive sleep apnea is a risk factor for hypertension, stroke, and myocardial infarction.

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 Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Multiple Pre-Defined Values Selected

C19092 Urinary tract surgical procedure other text UrinaryTractSurgProcedOTH The free text field related to "Urinary tract surgical procedures indicator" specifying the other text. The type of procedure The free text field related to "Urinary tract surgical procedures indicator" specifying the other text. The type of procedur other, 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 Supplemental 1.00 2014-05-27 15:15:49.0 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

C21629 Hip instability indicator HipInstabilityInd Indicator related to whether the participant/subject has any hip instability, subluxation or pelvic obiquity Indicator related to whether the participant/subject has any hip instability, subluxation or pelvic obiquity Hip instability, subluxation and pelvic obiquity No;Yes No;Yes Alphanumeric

Choose one

Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06315 Orgasmic function scale OrgasmicFunctScale Scale that assesses orgasmic function. Females: Orgasm is the perception of sensation of feeling good through sexual stimulation, of reaching a climax after which the woman feels gratified. May be accompanied by an overall increase and then decrease in muscle tone. The potential is based on history. Males: Orgasm is the perception of sensation of a peak feeling of sexual release, or climax, after which the man feels gratified. It may be accompanied by an overall increase and then decrease in muscle tone and may or may not be accompanied by ejaculation. The potential is based on history Psychogenic genital arousal usually manifests itself as the presence of clitoral engorgement and vaginal lubrication, amongst other signs, and occurs from arousal generated from the brain e.g. through hearing, seeing, feeling or fantasy (erotic thoughts) Orgasmic Function Normal;Reduced/altered;Absent;Unknown Normal;Reduced/altered;Absent;Unknown Alphanumeric

Choose one
Normal refers to reports by individuals that there is no change in their ability to achieve orgasm or sensations or orgasm subsequent to their spinal cord lesion.
Reduced/altered, orgasm occurs after spinal cord lesion even if itis reported to take longer to occur and/or the feelings associated with orgasm are different, i.e. may be possible, though partially impaired.
Absent refers to inability to achieve orgasm after spinalcord lesion despite trying to achieve orgasm on multiple occasions.
Unknown refers to reports by individuals that they have not been sexually active thus they do not know if they are able to achieve orgasm after spinal cord lesion.

Alexander MS, Biering-S&Oslash;rensen F, Elliott S, Kreuter M, S&Oslash;nksen J. International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set. Spinal Cord. 2011 Jul;49(7):787-90. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C17417 Urine dipstick test nitrite status UrDipstckTstNitrStatus Status of nitrite presence in urine dipstick test Status of nitrite presence in urine dipstick test Urine dipstick test for nitrite (tick one only): Negative;Positive;Unknown Negative;Positive;Unknown Alphanumeric

The results can be recorded as negative, positive or unknown. An unknown result could occur from the test being unreadable, unusable, or not done.

Goetz LL, Cardenas DD, Kennelly M, Bonne Lee BS, Linsenmeyer T, Moser C, Pannek J, Wyndaele JJ, Biering-Sorensen F. International spinal cord injury urinary tract infection basic data set. Spinal Cord. 2013 Sep;51(9):700-4. doi: 10.1038/sc.2013.72. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06194 Bowel function medication constipating agent type BwlFUncMedConstAgtTyp Type of medication affecting bowel function / constipating agents Type of medication affecting bowel function / constipating agents If yes, specify medication affecting bowel function/constipating agents Anticholinergics;Narcotics;Other,specify Anticholinergics;Narcotics;Other, specify Alphanumeric

For each medication type indicate if it was used. This element does not only include orally taken agents, patches, suppositories, injections, or laxatives.
A number of drugs affect gastrointestinal motility. The most commonly used among individuals with SCI are probably anticholinergics and narcotics. Other common examples are: calcium antagonists, diuretics, serotonin reuptake inhibitors, and spasmolytics. Many drugs affect gastrointestinal function and it is impractical to give an exact list of them all. It does not only include orally taken agents but also patches, suppositories and injections. It does not include laxatives.
Constipating agents, especially loperamide, taken by a minority of individuals with SCI against fecal incontinence should also be listed here.

Krogh K, Perkash I, Stiens SA, Biering-S&Oslash;rensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Multiple Pre-Defined Values Selected

C06219 Flatus incontinence frequency FltsIncntncFreq The frequency of flatus incontinence within the last three months. The frequency of flatus incontinence within the last three months. Frequency of flatus incontinence (within the last three months): Daily;Not every day but at least once per week;Not every week but at least once per month;Less than once per month;Never;Not applicable;Unknown Daily;Not every day but at least once per week;Not every week but at least once per month;Less than once per month;Never;Not applicable;Unknown Alphanumeric

Choose one. The code "Not applicable" is mainly for individuals with stomas.

Krogh K, Perkash I, Stiens SA, Biering-S&Oslash;rensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06406 Hypohidrosis past three months status HypohdrPstThreeMoStatus Status of whether the subject had hypohidrosis after spinal cord lesion within the last three months. Hypohidrosis is defined as a loss of ability to sweat and is normally seen below the level of injury due to disruption of sympathetic outflow. Hypohidrosis may be total or partial Status of whether the subject had hypohidrosis after spinal cord lesion within the last three months. Hypohidrosis is defined as a loss of ability to sweat and is normally seen below the level of injury due to disruption of sympathetic outflow. Hypohidrosis may be total or partia Thermoregulation history after spinal cord lesion within the last three months Hypohidrosis Above lesion;Below lesion;Unknown Above lesion;Below lesion;Unknown Alphanumeric

Choose one

Karlsson AK, Krassioukov A, Alexander MS, Donovan W, Biering-S&Oslash;rensen F. International spinal cord injury skin and thermoregulation function basic data set. Spinal Cord. 2012 Jul;50(7):512-6. doi: 10.1038/sc.2011.167. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C02411 Laterality type LatTyp Laterality type relative to the anatomic site of the body examined or affected Laterality type relative to the anatomic site of the body examined or affected Pain locations sites Left;Right Left;Right Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C18787 Defecation method bowel care procedure used past four week supplementary other text DefctnMthdBwlProcedUseSuppOTH The free-text field related to 'Defecation method bowel care procedure used past four week supplementary type' specifying other text. Type or types of supplemental defecation methods and bowel care procedures used within the last four weeks. Supplementary methods should be performed at least once every week The free-text field related to 'Defecation method bowel care procedure used past four week supplementary type' specifying other text. Type or types of supplemental defecation methods and bowel care procedures used within the last four weeks. Supplementary methods should be performed at least once every wee Other, specify Alphanumeric Krogh K, Perkash I, Stiens SA, Biering-S&Oslash;rensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

C06239 Constipation lifestyle alteration past three months scale ConstptnLifstylAltPstThrMoScl The scale that assesses lifestyle alteration due to constipation within the last three months. The scale that assesses lifestyle alteration due to constipation within the last three months. Lifestyle alteration due to constipation (within the last three months): Lifestyle altered each day;Lifestyle altered at least once per week but not every day;Lifestyle altered more than once per month but not every week;Lifestyle altered once per month;Lifestyle altered less than once per month;Lifestyle not altered;Not applicable;Unknown Lifestyle altered each day;Lifestyle altered at least once per week but not every day;Lifestyle altered more than once per month but not every week;Lifestyle altered once per month;Lifestyle altered less than once per month;Lifestyle not altered;Not applicable;Unknown Alphanumeric

Choose one. This variable only covers altered lifestyle due constipation related symptoms including difficult bowel evacuation. Examples may by avoidance of social activities, traveling etc.

Krogh K, Perkash I, Stiens SA, Biering-S&Oslash;rensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06439 Fracture date FractrDate Date (and time, if applicable and known) the fracture occurred at each site Date (and time, if applicable and known) the fracture occurred at each site Date of fracture 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 data set. Spinal Cord. 2012 Nov;50(11):797-802; doi: 10.1038/sc.2012.102. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Free-Form Entry

C06110 Pneumonia episode treat antibiotic past year number PnmnaEpsdTrtAntibtcPstYrNum Number of pneumonia episodes treated with antibiotics occurring after the spinal cord lesion and within the last year Number of pneumonia episodes treated with antibiotics occurring after the spinal cord lesion and within the last year Number of episodes treated with antibiotics Numeric Values

Only answer if there is a history of pneumonia after spinal cord lesion and within the last year. If number of episodes is unknown then code 999 (999 = Unknown).

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 Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Free-Form Entry

C19356 Thermoregulation past three months reported type ThermoPastThreeMnthRepTyp The type of reported mechanism to regulate body temperature in the past three months The type of reported mechanism to regulate body temperature in the past three month Thermoregulation history after spinal cord lesion within the last three months Hyperthermia;Hypothermia;Hyperhidrosis;Hypohidrosis;Other, specify;None of the above;Unknown Hyperthermia;Hypothermia;Hyperhidrosis;Hypohidrosis;Other, specify;None of the above;Unknown Alphanumeric

Choose one
Hyperthermia, usually defined as rectal temperature above 38.4 C, as well as hypothermia, defined as rectal temperature below 35 C may be caused by an infection. Hyper and hypothermia may also be caused by non infectious reasons as exercise or by increased or decreased environmental temperature; the individual with spinal cord lesion is prone tobe poikilothermic. Hyperhidrosis is defined as excessive sweating above or below level of injury in the absence of increased ambient temperature. Hyperhidrosis may be a sign of an ongoing pathological process such as syringomyelia, autonomic dysreflexia, or dyspepsia or may accompany micturition and defecation. Hyperhidrosis may also be present without any known cause. Hypohidrosis is defined as a loss of ability to sweat and is normally seen below the level of injury due to disruption of sympathetic outflow. Hypohidrosis may be total or partial. Other thermoregulatory (for example subjective feeling of coldness) and sudomotor findings may be present and should be specified.

Karlsson AK, Krassioukov A, Alexander MS, Donovan W, Biering-S&Oslash;rensen F. International spinal cord injury skin and thermoregulation function basic data set. Spinal Cord. 2012 Jul;50(7):512-6. doi: 10.1038/sc.2011.167. Adult;Pediatric Supplemental 1.00 2014-06-12 12:12:56.0 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C21630 Instability assessment method type InstabAssmntMethdTyp Type of method(s) used to determine the presence of hip instability Type of method(s) used to determine the presence of hip instabilit If yes, method of assessment Observation;Palpation;Radiographs Observation;Palpation;Radiographs Alphanumeric

(Check all that apply)

O'Brien MF. (2005). Spinal Deformity Study Group Radiographic Measurement Manual Medtronic Sofamor Danek USA, Inc. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Multiple Pre-Defined Values Selected

C06316 Menstruation scale MenstruationScale Scale for how the female participant's menstruation is affected by the spinal cord injury Scale for how the female participant's menstruation is affected by the spinal cord injur Menstruation Normal;Reduced/altered;Unknown;Not applicable (For female);Not applicable (Patient male) Refers to no change in duration, frequency or quantity of menstrual flow and no change in subjective experience or symptoms of menstruation after the spinal cord lesion;i.e. Menstruation has been initiated, though partially impaired or changed. This refers to a change in the duration, frequency or amount of menstrual blood flow after spinal cord lesion. It can also refer to a change in the quality of sensations or other autonomic phenomena associated with menses;Means the impact of the spinal cord lesion on menstruation is unknown;Means the woman was not menstruating at the time of spinal cord lesion, thus there is not an impact on menstruation; Alphanumeric

Choose one
Normal refers to no change in duration, frequency or quantity of menstrual flow and no change in subjective experience or symptoms of menstruation after the spinal cord lesion.
Reduced/altered, i.e. menstruation has been initiated, though partially impaired or changed. This refers to a change in theduration, frequency or amount of menstrual blood flow after spinal cord lesion. It can also refer to a change in the quality of sensations or other autonomic phenomena associated with menses.
Unknown means the impact of the spinal cord lesion on menstruation is unknown.
Not applicable means the woman was not menstruating at the time of spinal cord lesion, thus there is not an impact on menstruation.

Alexander MS, Biering-S&Oslash;rensen F, Elliott S, Kreuter M, S&Oslash;nksen J. International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set. Spinal Cord. 2011 Jul;49(7):787-90. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C17418 Urine dipstick test leukocyte esterase status UrDipstckTstLeukEstrseStatus Status of leukocyte esterase presence in urine dipstick test which indicates the presence of white blood cells in a urine sample Status of leukocyte esterase presence in urine dipstick test which indicates the presence of white blood cells in a urine sampl Urine dipstick test for leukocyte esterase (tick one only): Negative;Positive;Unknown Negative;Positive;Unknown Alphanumeric

The results can be recorded as negative, positive or unknown. An unknown result could occur from the test being unreadable, unusable, or not done.

Goetz LL, Cardenas DD, Kennelly M, Bonne Lee BS, Linsenmeyer T, Moser C, Pannek J, Wyndaele JJ, Biering-Sorensen F. International spinal cord injury urinary tract infection basic data set. Spinal Cord. 2013 Sep;51(9):700-4. doi: 10.1038/sc.2013.72. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06195 Constipating agent fecal incontinence drug last four week indicator ConAgFeclInconLstFourWkInd Indicator related to whether a constipating agent or drugs against fecal incontinence were used in the last four weeks Indicator related to whether a constipating agent or drugs against fecal incontinence were used in the last four weeks Constipating agents/drugs against fecal incontinence Yes;No;Unknown Yes;No;Unknown Alphanumeric

(within the last four weeks)

Krogh K, Perkash I, Stiens SA, Biering-S&Oslash;rensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06220 Fecal incontinence liquid stools frequency FclIncntncLiqStlFreq The frequency of fecal incontinence to liquid stools within the last three months. The frequency of fecal incontinence to liquid stools within the last three months. Frequency of incontinence to liquid stools (within the last three months): Two or more episodes per day;Once daily;Not every day but at least once per week;Not every week but more than once per month;Once per month;Less than once per month;Never;Not applicable;Unknown Two or more episodes per day;Once daily;Not every day but at least once per week;Not every week but more than once per month;Once per month;Less than once per month;Never;Not applicable;Unknown Alphanumeric

Choose one. If the individual has not had liquid stools within the last three months the code "Never" and not the code "Unknown" should be used. In individuals with episodes of fecal incontinence to liquid stools before the last three months without any episodes within in the last three months the code "Never" and not the code "Less than once per month" be should used. The code "Not applicable" is mainly for individuals with stomas.

Krogh K, Perkash I, Stiens SA, Biering-S&Oslash;rensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06407 Thermoregulation other issue past three month result text ThermOthIssPstThreeMoResltTxt Indicator of whether the subject had other types of thermoregulation conditions or events after spinal cord lesion within the last three months Indicator of whether the subject had other types of thermoregulation conditions or events after spinal cord lesion within the last three month Thermoregulation history after spinal cord lesion within the last three months Other, specify Alphanumeric

Choose one. If yes than specify the condition.

Karlsson AK, Krassioukov A, Alexander MS, Donovan W, Biering-S&Oslash;rensen F. International spinal cord injury skin and thermoregulation function basic data set. Spinal Cord. 2012 Jul;50(7):512-6. doi: 10.1038/sc.2011.167. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

C05452 Spinal injury anatomic site SpnlInjAntmicSit Anatomic site(s) of the spine injury represented as level(s) of the spinal-injured vertebrae Anatomic site(s) of the spine injury represented as level(s) of the spinal-injured vertebra Spinal column injury level C0;C1;C2;C3;C4;C5;C6;C7;L1;L2;L3;L4;L5;S1;S2;S3;S4-5;T1;T2;T3;T4;T5;T6;T7;T8;T9;T10;T11;T12 C0;C1;C2;C3;C4;C5;C6;C7;L1;L2;L3;L4;L5;S1;S2;S3;S4-5;T1;T2;T3;T4;T5;T6;T7;T8;T9;T10;T11;T12 Alphanumeric

The element may be included if relevant to the study. For additional details like permissible values, see the data dictionary associated with this CRF.
The element may be included if relevant to the study. For additional details like permissible values, see the data dictionary associated with this CRF.
vC00 represents C0 and is the occiput.
The code vX99 should be used only if the level is completely unknown.
In the case of multiple spinal injuries, a separate entry will be completed for each spinal column injury level.

Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International Spinal Cord Injury Spinal Column Injury Basic Data Set. Spinal Cord. 2012 Nov;50(11):817-821; doi: 10.1038/sc.2012.60. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Clinical Assessment Physical Examinations Assessments and Examinations

Multiple Pre-Defined Values Selected

C18790 Perianal problem other text PerianlProbOTH The free-text field related to Perianal problem type' specifying other text. Type of problem with the anus found in the perianal space The free-text field related to Perianal problem type' specifying other text. Type of problem with the anus found in the perianal space Other, specify Alphanumeric

For each perianal problem indicate if it was experienced. Perianal problems may change with time and only those present within the last year should be noted.

Krogh K, Perkash I, Stiens SA, Biering-S&Oslash;rensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

CSV