CDE Detailed Report

Disease: Spinal Cord Injury
Subdomain Name: Physical Examinations
CRF: Clinical Assessment

Displaying 51 - 100 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
C06240 Bowel dysfunction impact life quality scale BwlDysfnctnImpctLifQualtyScale The self report scale that describes impact on quality of life caused by neurogenic bowel dysfunction. The self report scale that describes impact on quality of life caused by neurogenic bowel dysfunction. Self reported impact on quality of life due to bowel dysfunction Major impact;Some impact;Little impact;No impact;Unknown Major impact;Some impact;Little impact;No impact;Unknown Alphanumeric

Choose one. Self reported impact on quality of life caused by neurogenic bowel dysfunction covers the subject's own assessment of the impact of all aspects of neurogenic bowel dysfunction.

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

C06447 Spasticity spasm indicator SpasctySpsmInd Indicator of the presence of spasticity/spasms Indicator of the presence of spasticity/spasms Presence of spasticity/spasms Yes;No;Unknown Yes;No;Unknown Alphanumeric

The presence of spasticity / spasms in the upper and lower extremities is captured using the modified Ashworth scale (MAS), i.e. greater than 1 on the MAS, or observation of spasms.

Bohannon RW, Smith MB. Interrater reliability of a Modified Ashworth Scale of muscle spasticity. Physical Therapy. 1987:67:206-7.<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.<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

C06111 Pneumonia episode require hospitalization past year number PnmnaEpsdReqHsptlztnPstYrNum Number of pneumonia episodes requiring hospitalization occurring after the spinal cord lesion and within the last year Number of pneumonia episodes requiring hospitalization occurring after the spinal cord lesion and within the last year Number of episodes requiring hospitalization 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

C19357 Diagnosis new during hospital stay indicator DiagNewDuringHospStayInd New diagnoses during hospital stay New diagnoses during hospital stay New diagnosis (indicate SNOMED term and code), describe No;Yes;Unknown No;Yes;Unknown Alphanumeric

Choose one

Adult;Pediatric Supplemental 1.00 2014-06-12 12:38:52.0 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C21631 Swallowing post-SCI problem indicator SwallowingPostSCIProbInd Subject's response concerning problems with swallowing post-SCI Subject's response concerning problems with swallowing post-SC Since your spinal cord injury, have you had any problems with your swallowing? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2014-01-06 00:00:00.0 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06317 Psychogenic erection scale PsychogenicErectionScale Psychogenic erection is erection that occurs solely based on arousal in the brain e.g. through hearing, seeing, feeling or fantasy (erotic thoughts). Psychogenic erection is penile tumescence with resulting increase in size and firmness of the penis that occurs without physical stimulation, which in usual circumstances should be adequate to allow penetration Psychogenic erection is erection that occurs solely based on arousal in the brain e.g. through hearing, seeing, feeling or fantasy (erotic thoughts). Psychogenic erection is penile tumescence with resulting increase in size and firmness of the penis that occurs without physical stimulation, which in usual circumstances should be adequate to allow penetratio Pyschogenic Erection Absent;Normal;Not applicable (Patient female);Reduced/altered;Unknown Refers to a complete inability to achieve penile tumescence and firmness to psychologic stimulation after the spinal cord lesion;Refers to presence of an ability to achieve and maintain erections in response to psychologic stimulation after spinal cord lesion that is equivalent in quality and duration as prior to spinal cord lesion;;Refers to presence of an ability to achieve erections in response to psychologic stimulation that is partially impaired or altered in quality and/or duration as compared to prior to the spinal cord lesion;Refers to reports by individuals that have not been sexually active after the spinal cord lesion thus they do not know if they have changes in psychogenic erection Alphanumeric

Choose one
In able-bodied men erections are usually a combination of psychogenic and reflex; however, in men with spinal cord lesions, varying types of erectile function may be preserved (Courtois, 1993, 1995; Giuliano 1995).
Psychogenic erection potential may be based on degree of preservation of sensory function in T11-L2 dermatomes.

Alexander MS, Biering-S&Oslash;rensen F, Elliott S, Kreuter M, S&Oslash;nksen J. International Spinal Cord Injury Male Sexual Function Basic Data Set. Spinal Cord. 2011 Jul;49(7):795-8. Courtois FJ, Charvier KF, Leriche A, Raymond DP. Sexual function in spinal cord injured men. I. Assessing sexual capacity. Paraplegia. 1993;31:771-784. Courtois FJ, Charvier KF, Leriche A, Raymond DP, Eyssette M. Clinical approach to erectile dysfunction in spinal cord injured men. A review of clinical and experimental data. Paraplegia. 1995;33;628-635. Giuliano FA, Rampin O, Benoit G Jardin A. Neural control of penile erection. Uro Clin North Am. 1995;22(4):747-66. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C17419 Urinary culture status UrCultStatus Status of urine culture result Status of urine culture result Urine culture (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

C06198 Perianal problem type PerianlProbTyp Type of problem with the anus found in the perianal space Type of problem with the anus found in the perianal space Perianal problems (within the last year): Hemorrhoids;Perianal sores;Fissures;Other, specify;Unknown Hemorrhoids;Perianal sores;Fissures;Other, specify;Unknown 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.
Due to staining and assisted defecation haemorrhoids, fissures, and rectal prolapse are more common among individuals with SCI than in the general population. Anal soiling may contribute to perianal sores. In the present data set perianal sores are located within the crena ani or the perineum and not on the buttocks or lower back. For practical purposes no distinction is made in the present data set between rectal mucosal prolapse and full-wall rectal prolapse.

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

C06221 Fecal incontinence solid stools frequency FclIncntncSldStlFreq The frequency of fecal incontinence to solid stools within the last three months. The frequency of fecal incontinence to solid stools within the last three months. Frequency of incontinence to solid 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

In individuals with episodes of fecal incontinence to solid stools before the last three months without any episodes within the last three months the code "Never" and not the code "Less than once per month" 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

C06408 Skin thermoregulation pressure ulcer present indicator SkiThermPressrUlcPrstInd Indicator of the presence of a pressure ulcer at the time of investigation Indicator of the presence of a pressure ulcer at the time of investigatio Any pressure ulcer at present Yes;No;Unknown Yes. If yes. Fill in one diaram for each ulce by indicating the ulcerstage (I II III IV U (nstageable)) at the appropriate location;No;Unknown Alphanumeric

Choose one
A pressure ulcer could be present at any time post spinal cord injury. This variable documents the presence of pressure ulcer(s) at the time of investigation. An ulcer is usually seen on prominent body structures and caused by pressure on the region. The location of the pressure ulcer should be documented including right/left side of the body when applicable.

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

C06005 Data collected date and time DataCollDateTime Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performe Assessment Date/Time 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.).
Injury through the spinal column is defined as any break, rupture, ligament tear, disruption, or crack through the bony vertebral elements or through the non-bony disc and ligamentous soft tissues between the vertebrae from the occipital condyles to the sacrum. Patients with cervical spondylosis and spinal stenosis may suffer a traumatic spinal cord injury without a spinal column injury.

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):817-21. Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Clinical Assessment Physical Examinations Assessments and Examinations

Free-Form Entry

C18791 Bowel care position past three months other text BowelCrPostnPstThrMoOTH The free-text field related to 'Bowel care position past three months type' specifying other text. The indicator of whether the bowel care position was used within the past three months The free-text field related to 'Bowel care position past three months type' specifying other text. The indicator of whether the bowel care position was used within the past three month Other, specify Alphanumeric

For each bowel care position indicate if it was used within the last three months

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 4000

Free-Form Entry

C06241 Anal tone examination result AnlTnExamReslt The result of digital examination of anal tone. The result of digital examination of anal tone. Anal tone (based on physical examination) Normal;Reduced;Excessive;Not tested;Not applicable Normal;Reduced;Excessive;Not tested;Not applicable Alphanumeric

Based on physical examination

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

Single Pre-Defined Value Selected

C06449 Heterotopic ossification detection method type HetrotpcOssfctnDetctnMethdTyp Type of method used to document the heterotopic ossification Type of method used to document the heterotopic ossification Method used to document heterotopic ossification, if present X-ray;CT-scan;Triple phase bone scan;Other, specify X-ray;CT-scan;Triple phase bone scan;Other method Alphanumeric

Indicate the method used to confirm the presence of heterotopic ossification

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

Multiple Pre-Defined Values Selected

C06112 Ventilatory assistance type VentiltryAsstTyp Type of assistance device utilized to augment ventilation Type of assistance device utilized to augment ventilation Current Utilization of Ventilatory Assistance Bi-level Positive Airway Pressure;Diaphragmatic pacing device;Mechanical ventilation;None;Other,specify;Phrenic Nerve Stimulation;Unknown Bi-level Positive Airway Pressure (BiPAP);Diaphragmatic pacing device;Mechanical ventilation;None;Other, specify;Phrenic Nerve Stimulation;Unknown 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.
Respiratory insufficiency is common following spinal cord lesions. Ventilatory assistance devices include, but are not limited to: mechanical ventilators, phrenic nerve stimulators, diaphragmatic pacers, external
negative pressure devices, and bi-level positive airway pressure (BiPAP). These devices do not include routine administration of oxygen, intermittent positive pressure breathing (IPPB), or continuous positive airway pressure (CPAP). Wording of this variable reflects the International Spinal Cord Injury Core Data Set for the type of ventilatory assistance used to sustain respiration at discharge after the initial rehabilitation period following the spinal lesion (DeVivo et al. 2006). As the situation may have changed since discharge from the initial inpatient period the question is asked.

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

C19467 Bladder empty method main other text BladEmpMethdMainOTH The free-text field to specify the main method of bladder emptying The free-text field to specify the main method of bladder emptyin Other method, specify Alphanumeric Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. 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. 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 4000

Free-Form Entry

C21663 Urinary tract surgical procedure type UrinaryTractSurgProcedTyp Indicate which type of surgical procedure was performed on the urinary tract Indicate which type of surgical procedure was performed on the urinary trac Surgical procedures on the urinary tract: No;Unknown;Yes, artificial sphincter, date last performed YYYYMMDD;Yes, bladder augmentation, date last performed YYYYMMDD;Yes, bladder stone removal, date last performed YYYYMMDD;Yes, botulinum toxin injection, date last performed YYYYMMDD;Yes, continent catheterizable valves, date last performed YYYYMMDD;Yes, ileouresterostomy, date last performed YYYYMMDD;Yes, ileovesicostomy, date last performed YYYYMMDD;Yes, other, specify…date performed YYYYMMDD;Yes, sacral anterior root stimulator, date last performed YYYYMMDD;Yes, sphincterotomy/urethral stent, date last performed YYYYMMDD;Yes, supra-pubic catheter insertion, date last performed YYYYMMDD;Yes, upper urinary tract stone removal, date last performed YYYYMMDD No;Unknown;Yes, artificial sphincter, date last performed YYYYMMDD;Yes, bladder augmentation, date last performed YYYYMMDD;Yes, bladder stone removal, date last performed YYYYMMDD;Yes, botulinum toxin injection, date last performed YYYYMMDD;Yes, continent catheterizable valves, date last performed YYYYMMDD;Yes, ileouresterostomy, date last performed YYYYMMDD;Yes, ileovesicostomy, date last performed YYYYMMDD;Yes, other, specify…date performed YYYYMMDD;Yes, sacral anterior root stimulator, date last performed YYYYMMDD;Yes, sphincterotomy/urethral stent, date last performed YYYYMMDD;Yes, supra-pubic catheter insertion, date last performed YYYYMMDD;Yes, upper urinary tract stone removal, date last performed YYYMMDD 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 15:00:45.0 Clinical Assessment Physical Examinations Assessments and Examinations

Multiple Pre-Defined Values Selected

C06318 Reflex erection scale ReflexErectionScale A reflex erection is penile tumescence with resulting increase in size and firmness of the penis that occurs with genital stimulation, which in usual circumstances should be adequate to allow vaginal penetration A reflex erection is penile tumescence with resulting increase in size and firmness of the penis that occurs with genital stimulation, which in usual circumstances should be adequate to allow vaginal penetratio Reflex Erection Absent;Normal;Not applicable (Patient female);Reduced/altered;Unknown Refers to a complete inability to achieve penile tumescence and firmness to genital stimulation after the spinal cord lesion;Refers to the presence of a reflex erection to genital stimulation that is equivalent in quality and duration as prior to spinal cord lesion;;Refers to presence of an ability to achieve erections in response to genital stimulation that is partially impaired or altered in quality and/or duration as compared to prior to the spinal cord lesion;Refers to reports by individuals that have not been sexually active after the spinal cord lesion thus they do not know if they have changes in reflex erection Alphanumeric

Choose one
In able-bodied men erections are usually a combination of psychogenic and reflex; however, in men with spinal cord lesion, varying types of erectile function may occur. Reflex erection potential is based on presence of reflex
function in S2-5 spinal segments.

Alexander MS, Biering-S&Oslash;rensen F, Elliott S, Kreuter M, S&Oslash;nksen J. International Spinal Cord Injury Male Sexual Function Basic Data Set. Spinal Cord. 2011 Jul;49(7):795-8. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C17420 Urinary culture species text UrCultSpecTxt Text to name a bacteria species in urine culture sample Text to name a bacteria species in urine culture sample If positive, give species 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

C06199 Perianal problem experienced last year indicator PerianlProbExpLastYrInd Indicator of whether the perianal problem was experienced within the last year Indicator of whether the perianal problem was experienced within the last year Perianal problems Yes;No Yes;No Alphanumeric

within the last four weeks

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

Single Pre-Defined Value Selected

C06222 Defecation deferral past three months indicator DefctnDefrlPstThrMoInd The indicator of the ability to defer defecation for 15 minutes or more within the last three months. The indicator of the ability to defer defecation for 15 minutes or more within the last three months. Ability to defer defecation for fifteen minutes or more (within the last three months): Yes;No;Not applicable;Unknown Yes;No;Not applicable;Unknown Alphanumeric

Choose one. The code "Not applicable" is mainly for individuals with stomas or individuals without sensation of need to defecate.

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

C06409 Skin thermoregulation pressure ulcer past year indicator SkiThermPressrUlcPstYrInd Indicator of the presence of a pressure ulcer during the last 12 months Indicator of the presence of a pressure ulcer during the last 12 months Any other pressure ulcer during the last 12 months: Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one
A pressure ulcer could have been present at any time post spinal cord injury. This variable documents the presence and location of any other skin ulcer(s) during the period of the last 12 months only.

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

C06014 Bladder empty need awareness indicator BladEmpNeedAwreInd Indicator of whether the participant is aware that he/she needs to empty his/her bladder Indicator of whether the participant is aware that he/she needs to empty his/her bladde Awareness of the need to empty the bladder No;Yes;Not applicable;Not known No;Yes;Not applicable;Not known Alphanumeric

Choose one. Awareness of the need to empty the bladder indicates any kind of bladder sensation as defined by International Continence Society (Abrams et al. 2002), i.e. normal (the individual is aware of bladder filling and increasing sensation up to a strong desire to void), increased (the individual feels an early and persistent desire to void), reduced (the individual is aware of bladder filling but does not feel a definite desire to void) or non-specific bladder sensation (the individual reports no specific bladder sensation, but may perceive bladder filling as abdominal fullness, vegetative symptoms like sweating or spasticity). No awareness of the need to empty the bladder should be noted as "no". Absent bladder sensation according to the definition of bladder sensation by the International Continence Society (the individual reports no sensation of bladder filling or desire to void) (Abrams et al. 2002) is not exactly the same as filling sensation and desire to void can be absent while temperature sensation or electrosensation can be present. "Not applicable" is to be used when the individual with spinal cord lesion has for example an unclamped indwelling catheter or non-continent urinary diversion.

Response of "Not applicable" includes too young to determine.

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. 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 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C18792 Bowel care facilitators past three months other text BowelCrFacltatrPstThrMoOTH The free-text field related to 'Bowel care facilitators past three months type' specifying other text. The indicator of whether the type of bowel care facilitator was practiced regularly within the past three months The free-text field related to 'Bowel care facilitators past three months type' specifying other text. The indicator of whether the type of bowel care facilitator was practiced regularly within the past three month Other, specify Alphanumeric

For each bowel care facilitator indicate if it was used regularly within the past three months.

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 4000

Free-Form Entry

C06242 Anal canal voluntary contraction indicator AnlCnlVolContrctnInd Indicator of whether the anal canal can voluntary contract. This is the result of the digital evaluation of voluntary contraction of the anal canal and is an assessment of the voluntary function of the external anal sphincter muscle Indicator of whether the anal canal can voluntary contract. This is the result of the digital evaluation of voluntary contraction of the anal canal and is an assessment of the voluntary function of the external anal sphincter muscl Voluntary contraction of the anal canal (based on physical examination) Yes;No;Not assessed;Not applicable Yes;No;Not assessed;Not applicable Alphanumeric 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

C06450 Neuromuscular scoliosis indicator NeuromusclrSclsisInd Indicator of any appreciable observable lateral deviation in the normally straight vertical line of the spine due to the sequelae of spinal cord injury (SCI) Indicator of any appreciable observable lateral deviation in the normally straight vertical line of the spine due to the sequelae of spinal cord injury (SCI) Scoliosis Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one
No: The head is aligned over the pelvis during unsupported sitting (not balanced with arms/hands; lateral supports; chest straps; etc) or while standing erect.
Yes: There is an observable deviation of the head over the trunk and pelvis during unsupported sitting or standing due to scoliosis as a comorbidity of SCI.
Note: This variable does not include problems with the alignment of the spine due to problems other than SCI, such as Idiopathic Scoliosis; pre-injury neuromuscular scoliosis, as in Marfan's Syndrome; Larson's Syndrome; Downs Syndrome; Klippel Feil Syndrome, degenerative disk disease, osteoporosis in the aging spine, etc. There is a wide range of normal variation in sagittal profiles and it is possible that each individual has specific requirements for cervical/lumbar lordosis and thoracic kyphosis as a result of pelvic orientation. Scoliosis is defined as a 10 degree curvature of the spine (Scoliosis Research Society, 1976).
Scoliosis is a known musculoskeletal complication of SCI, particularly when SCI occurs at a younger age (Brown et al. 1984; Campbell & Bonnett 1975; Dearolf et al. 1990; Lancourt et al. 1981; Mayfield et al. 1981; Vogel et al. 2003; Lubicky & Betz 1996).

Brown JC, Swank SM, Matta J, Barras DM. Late spinal deformity in quadriplegic children. J Pediatric Orthopedics, 1984;4:456-461.<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

C06114 Mechanical ventilation utilization frequency MechnclVentUtlztnFreq Specifies frequency that the participant/ subject uses mechanical ventilation Specifies frequency that the participant/ subject uses mechanical ventilation Mechanical ventilation Less than 24 hours per day;24 hours per day;Unknown number of hours per day Less than 24 hours per day;24 hours per day;Unknown number of hours per day Alphanumeric

Respiratory insufficiency is common following spinal cord lesions. Ventilatory assistance devices include, but are not limited to: mechanical ventilators, phrenic nerve stimulators, diaphragmatic pacers, external negative pressure devices, and bi-level positive airway pressure (BiPAP). These devices do not include routine administration of oxygen, intermittent positive pressure breathing (IPPB), or continuous positive airway pressure (CPAP). Wording of this variable reflects the International Spinal Cord Injury Core Data Set for the type of ventilatory assistance used to sustain respiration at discharge after the initial rehabilitation period following the spinal lesion (DeVivo et al. 2006). As the situation may have changed since discharge from the initial inpatient period the question is asked.

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

Single Pre-Defined Value Selected

C19471 Neuromuscular scoliosis musculoskeletal problem assessment other text NeromusclrSclsisMusPrAssmntOTH The free-text field related to the other musculoskeletal problem being specified which the method used to determine the presence of neuromuscular scoliosis. This CDE is referring to C06451 The free-text field related to the other musculoskeletal problem being specified which the method used to determine the presence of neuromuscular scoliosis. This CDE is referring to C06451 Other musculoskeletal problems, specify Alphanumeric O'Brien MF. (2005). Spinal Deformity Study Group Radiographic Measurement Manual Medtronic Sofamor Danek USA, Inc.<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 4000

Free-Form Entry

C21664 Urinary tract surgical procedure date UrinaryTractSurgProcedDate Date when surgical procedure on the urinary tract was performed Date when surgical procedure on the urinary tract was performed Date performed Date or Date & Time 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 15:00:45.0 Clinical Assessment Physical Examinations Assessments and Examinations

Free-Form Entry

C06319 Ejaculation scale EjaculationScale Scale for how the male participant's ejaculation is affected by the spinal cord injury Scale for how the male participant's ejaculation is affected by the spinal cord injur Ejaculation Absent;Normal;Not applicable (Patient female);Reduced/altered;Unknown Refers to an absence of external semen propulsion to sexual stimulation following the spinal cord lesion despite attempts to ejaculate;Refers to normal antegrade ejaculation occurring after a similar amount of sexual stimulation as prior to spinal cord lesion;;Refers to ejaculation that is possible after sexual stimulation, but is changed after the spinal cord lesion in either time required to ejaculate, or changes in semen volume, color, or quality;Refers to reports by individuals that they have not been sexually active thus they do not know if they are able to achieve ejaculation after the spinal cord lesion Alphanumeric

Choose one
Normal refers to normal antegrade ejaculation occurring after a similar amount of sexual stimulation as prior to spinal cord lesion.
Reduced/altered, refers to ejaculation that is possible after sexual stimulation, but is changed after the spinal cord lesion in either time required to ejaculate, or changes in semen volume, color, or quality.
Absent refers to an absence of external semen propulsion to sexual stimulation following the spinal cord lesion despite attempts to ejaculate.
Unknown refers to reports by individuals that they have not been sexually active thus they do not know if they are able to achieve ejaculation after the spinal cord lesion.

Alexander MS, Biering-S&Oslash;rensen F, Elliott S, Kreuter M, S&Oslash;nksen J. International Spinal Cord Injury Male Sexual Function Basic Data Set. Spinal Cord. 2011 Jul;49(7):795-8. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C17421 Urinary culture colony form unity measurement value UrCultCFUMeasrVal Value of colony forming associated with a bacterial species measured in Colony Forming Units (CFU)/mL Value of colony forming associated with a bacterial species measured in Colony Forming Units (CFU)/mL If positive, give amount of colony Numeric Values 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

Free-Form Entry

10 100000 colony-forming units per milliliter
C06212 Bowel function SCI data constipation duration BowelFuncSCIDataConstipatDur The duration of participant's/subject's constipation. The duration of participant's/subject's constipation. Duration of constipation Less than a year;1-5 years;6-10 years;11-20 years;More than 20 years;Not applicable;Unknown Less than a year;1-5 years;6-10 years;11-20 years;More than 20 years;Not applicable;Unknown Alphanumeric

Choose one

Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology 2006; 130:1377-1390. <br /><br />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

C06224 Bowel care position past three months type BowelCrPostnPstThrMoTyp The indicator of whether the bowel care position was used within the past three months The indicator of whether the bowel care position was used within the past three months. Position for bowel care (within the last three months): Bed;Toilet chair/Commode;Raised toilet seat;Conventional toilet;Other, specify;Unknown Bed;Toilet chair/Commode;Raised toilet seat;Conventional toilet;Other, specify;Unknown Alphanumeric

For each bowel care position indicate if it was used within the last three months

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

Multiple Pre-Defined Values Selected

C06427 Spinal column injury indicator SpnlColmInjInd Indicator of whether there was any disruption through the spinal column including the bony vertebral elements and their supporting ligaments, capsules, discs, and other supporting soft tissues Indicator of whether there was any disruption through the spinal column including the bony vertebral elements and their supporting ligaments, capsules, discs, and other supporting soft tissue Spinal column injury (-ies) No;Yes;Unknown No;Yes;Unknown Alphanumeric

Being able to distinguish between single versus multiple levels of spinal column injury is often challenging. Critical to this distinction is the fact that a single injury may occur; i) at one vertebral level (e.g. C6 Burst Fracture); ii) at a single motion segment (e.g. a C5-6 bilateral facet dislocation) where a motion segment is defined as two adjacent vertebrae and their interconnecting discs and
ligamentous structures; or iii) over two or more adjacent and contiguousmotion segments (e.g. a "teardrop" fracture of C6 where the injury spans C5-C7). Alternately, a multiple level injury consists of two or more single column injuries separated by at least one completely intact vertebra or motion segment(e.g. a C5-6 facet dislocation and a C2 hangman's fracture).

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

C06015 Bladder empty method main type BladEmpMethdMainTyp Main method of bladder emptying Main method of bladder emptyin Bladder emptying Bladder expression;Bladder reflex triggering;External compression bladder expression;Indwelling catheter;Intermittent catheterisation;Intermittent catheterisation by attendant;Intermittent self-catheterisation;Involuntary bladder reflex triggering;Non-continent urinary diversion/ostomy;Normal voiding;Other method, specify;Sacral anterior root stimulation;Straining bladder expression;Suprapubic;Suprapubic indwelling catheter;Transurethral indwelling catheter;Unknown;Voluntary bladder reflex triggering Comprises various manoeuvres aimed at increasing intravesical pressure in order to facilitate bladder emptying. The most commonly used manoeuvres are abdominal straining, Valsalva's manoeuvre and CredÉ manoeuvre (Abrams et al. 2002).;Comprises various manoeuvres performed by the individual with spinal cord lesion or an attendant in order to elicit reflex detrusor contraction by exteroceptive stimuli. The most commonly used manoeuvres are suprapubic tapping, thigh scratching and anal/rectal manipulation (Abrams et al. 2002).;Includes CredÉ manoeuvre.;An indwelling catheter remains in the bladder, urinary reservoir or urinary conduit for a period of time longer than one emptying (Abrams et al. 2002).;Is defined as drainage or aspiration of the bladder or urinary reservoir/continent urinary diversion with subsequent removal of the catheter.;Is performed by an attendant (e.g. family member or personal aid);Is performed by the individual with spinal cord lesion himself/herself;Implies that there is no voluntary triggering of the voiding, but the individual with spinal cord lesion just let the urine run by itself when the reflex detrusor contraction occur by itself.;Non-continent urinary diversion/ostomy;Voluntary initiation of micturition without reflex stimulation or compression of the bladder. This does not presume entirely normal function (Levi and Ertzgaard 1998).;Other method, specify;Sacral anterior root stimulation;Includes abdominal straining, Valsalva's manoeuvre.;Suprapubic;indicates, that the urine is drained through a catheter via the abdominal wall.;Indicates, that the urine is drained through a catheter placed in the urethra.;Unknown;Indicates that the bladder reflex is triggered by the spinal cord lesioned individual him/herself or by the attendant. Alphanumeric

For each method of bladder emptying, indicate whether this is a main or a supplementary method. Two main and more supplementary methods may be indicated (adopted from Levi and Ertzgaard 1998).
Normal voiding: Voluntary initiation of micturition without reflex stimulation or compression of the bladder. This does not presume entirely normal function (Levi and Ertzgaard 1998).
Bladder reflex triggering comprises various manoeuvres performed by the individual with spinal cord lesion or an attendant in order to elicit reflex detrusor contraction by exteroceptive stimuli. The most commonly used manoeuvres are
suprapubic tapping, thigh scratching and anal/rectal manipulation (Abrams et al. 2002).
Voluntary bladder reflex triggering indicates that the bladder reflex is triggered by the spinal cord lesioned individual him/herself or by the attendant.
Involuntary bladder reflex triggering imply that there is no voluntary triggering of the voiding, but the individual with spinal cord lesion just let the urine run by itself when the reflex detrusor contraction occur by itself.
Bladder expressioncomprises various manoeuvres aimed at increasing intravesical pressure in order to facilitate bladder emptying. The most commonly used manoeuvres are abdominal straining, Valsalva's manoeuvre and CredÉ manoeuvre
(Abrams et al. 2002).
Straining includes abdominal straining, Valsalva's manoeuvre.
External compression includes CredÉ manoeuvre.
Catheterisation is a technique for bladder emptying employing a catheter to drain the bladder or a urinary reservoir (Abrams et al. 2002).
Intermittent catheterisation is defined as drainage or aspiration of the bladder or urinary reservoir / continent urinary diversion with subsequent removal of the catheter.
The following types of intermittent catheterisationare defined by the International Continence Society (Abrams et al. 2002):
Intermittent self-catheterisation is performed by the individual with spinal cord lesion himself/herself
Intermittent catheterisation can also be performed by an attendant (e.g. Family member or personal aid)
Indwelling catheterisation:an indwelling catheter remains in the bladder, urinary reservoir or urinary conduit for a period of time longer than one emptying (Abrams et al. 2002).
Transurethral indwelling catheterisationindicates that the urine is drained trough a catheter placed in the urethra.
Suprapubic indwelling catheterisation indicates that the urine is drained trough a catheter via the abdominal wall.
Sacral Anterior Root Stimulator (SARS): Emptying the bladder by electrical stimulation of the anterior sacral nerve roots via implanted electrodes.
Non-continent urinary diversion/ostomy: This includes ureteroileocutaneostomy (Bricker conduit), ileovesicostomy, vesicostomy. If any other method is used for bladder emptying it is recommended to be written in a text-field, from which it will be possible to retrieve more detailed data when necessary. Because other methods of bladder emptying are generally rare, it is not practical to give an inclusive list of bladder emptying methods. Use of diapers etc. because of incontinence is not to be reported here,but under "Collecting appliances for urinary incontinence".

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. 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. 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

Single Pre-Defined Value Selected

C18794 Cardiovascular event after spinal cord lesion other text CardioEvntAfterSpnlCrdLesnOTH The free-text field related to 'Cardiovascular event after spinal cord lesion type' specifying other text. Events related to cardiovascular functions that may have occurred at any time after the spinal cord lesion The free-text field related to 'Cardiovascular event after spinal cord lesion type' specifying other text. Events related to cardiovascular functions that may have occurred at any time after the spinal cord lesio Other, specify Alphanumeric Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

C06247 Cardiovascular event after spinal cord lesion type CardioEvntAfterSpnlCrdLesnTyp Events related to cardiovascular functions that may have occurred at any time after the spinal cord lesion. Events related to cardiovascular functions that may have occurred at any time after the spinal cord lesion. Events related to cardiovascular function after spinal cord lesion Cardiac pacemaker;Deep vein thrombosis;Myocardial infarction;None;Other,specify;Pulmonary embolism;Stroke;Unknown (any cardiovascular disorder) Cardiac pacemaker;Deep vein thrombosis;Myocardial infarction;None;Other, specify;Pulmonary embolism;Stroke;Unknown (any cardiovascular disorder) Alphanumeric

For each event related to cardiovascular function after spinal cord lesion record whether it was experienced by the participant.
These time-limited cardiovascular events with long-term sequelae should have their dates documented to be able to compute the time since injury and to identify the data collected in relation to various time points. If more than one episode has occured the last one has to be documented.

Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Multiple Pre-Defined Values Selected

C06451 Neuromuscular scoliosis assessment method type NeromusclrSclsisAssmntMethdTyp Type of method(s) used to determine the presence of neuromuscular scoliosis Type of method(s) used to determine the presence of neuromuscular scoliosi If scoliosis is present, method of assessment (check all that apply) Observation in sitting;Observation in standing;Plain radiographs in sitting;Plain radiographs in standing Observation in sitting;Observation in standing;Plain radiographs in sitting;Plain radiographs in standing Alphanumeric

Check all that apply
The clinical and physical examination is pivotal to the diagnosis of scoliosis and is evidenced by the observed lateral deviation of the head, trunk and pelvis over the spine and shoulder asymmetry. For the evaluation of neuromuscular scoliosis, it is important to temporarily remove any modification to a wheelchair or seating system that is providing external support to maintain head and spine alignment (for example, lateral supports, chest harness, etc) (Lubicky & Betz 1996; Lord et al. 1990; Mulcahey & Betz 2008). Likewise, any type of support to the trunk in the form of a brace or binder needs to be removed for assessment of the scoliosis. A diagnosis of scoliosis requires a plain radiograph that shows a Cobb Angle of at least 10 degrees (O'Brien 2005; Terminology committee of the Scoliosis Research Society 1976). While the Cobb Angle of 10 degrees is used as the definitive diagnoses for idiopathic scoliosis, there is evidence that strong inter-rater reliability of the Cobb Angle in SCI also falls within 10 degrees and hence, has been adopted as the radiographic diagnosis of neuromuscular scoliosis (Gupta et al. 2007).

O'Brien MF. (2005). Spinal Deformity Study Group Radiographic Measurement Manual Medtronic Sofamor Danek USA, Inc.<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

Multiple Pre-Defined Values Selected

C06186 Defecation awareness past four week status DefctnAwarePstFourWkStatus Awareness of the need to defecate within the last four weeks Awareness of the need to defecate (within the last four weeks): Awareness of the need to defecate within the last four weeks Normal;Indirect;None;Not applicable;Unknown Normal (Direct);Indirect (For example: Abdominal cramping or discomfort, abdominal muscle spasms, spasms of lower extremities, perspiration, piloerection, headache or chills);None;Not applicable (too young to determine);Unknown Alphanumeric

Choose one
Many individuals with SCI lack any awareness of the need to defecate. Others have indirect symptoms. These are mainly abdominal cramping or discomfort and spasms of the abdominal muscles or lower extremities. Autonomic symptoms including headache, perspiration, piloerection, and chills before or during defecation are common, especially in individuals with lesions above Th6 (Krogh et al. 1997). Autonomic symptoms are often unpleasant to the individual and may indicate insufficient bowel emptying. Lack of awareness of the need to defecate is especially common in individual with complete lesions and increases the risk of fecal incontinence. Symptoms may change with time and in the present data set they are given for the last four weeks.

Krogh K, Nielsen J, Djurhuus JC, Mosdal C, Sabroe S, Laurberg S. Colorectal function in patients with spinal cord lesions. Dis Colon Rectum 1997; 40: 1233-1239. 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

C19476 Bladder empty method supplementary other text BladEmpMethdSupplOTH The free-text field to specify the supplementary method of bladder emptying The free-text field to specify the supplementary method of bladder emptyin Other method, 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 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

C22704 Urinary incontinence past three months frequency UrinIncntPstThreeMoFreq Frequency of involuntary urine leakage (incontinence) within the last three months. Urinary incontinence is defined by International Continence Society (Abrams et al. 2002) as the complaint of any involuntary leakage of urine Frequency of involuntary urine leakage (incontinence) within the last three months. Urinary incontinence is defined by International Continence Society (Abrams et al. 2002) as the complaint of any involuntary leakage of urin If yes, indicate urine leakage average frequency Average daily;Average monthly;Average weekly Average daily (Implies leakage one or more times per day on average over the last three months).;Average monthly (Implies on average leakage one or more times per month but not weekly within the last three months).;Average weekly (Implies average leakage one or more times per week but not daily within the last three months). Alphanumeric Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. <br />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 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C06361 Gonadal male status GondlMalStatus Stage of gonadal development/senescence for males Stage of gonadal development/senescence for males Gonadal status (check appropriate stage): Adult;Prepubertal;Pubertal;Unknown Adult;Prepubertal;Pubertal;Unknown Alphanumeric

Choose one. Data element should be checked against Gender. Question should be blank for Females.

Bauman WA, Biering-S&Oslash;rensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

C17422 Urinary culture resistance pattern type UrCultResistPattrnTyp Type of resistance pattern of a particular bacteria species in the urine culture sample Type of resistance pattern of a particular bacteria species in the urine culture sample Resistance pattern (pick one only): Normal;Multi-drug resistant Normal;Multi-drug resistant (agents from 3 or more different drug classes) 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

Single Pre-Defined Value Selected

C06213 Defecation unsuccessful frequency DefctnUnscsflFreq The frequency of unsuccessful attempts at defecation within the last three months The frequency of unsuccessful attempts at defecation within the last three month Unsuccessful attempts at defecation (within the last three months): Never;Less than once per month;Less than once per week but at least once per month;Once or more per week but not every day;1-3 times daily;4-6 times daily;7-9 times daily;10 times or more per day;Not applicable;Unknown Never;Less than once per month;Less than once per week but at least once per month;Once or more per week but not every day;1-3 times daily;4-6 times daily;7-9 times daily;10 times or more per day;Not applicable;Unknown Alphanumeric

Choose one. To be considered as one attempt the bowel emptying procedure should be separated from the previous bowel emptying procedure by some other activity. 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

C06229 Bowel management independence past three months scale BowelMngmntIndpdncPstThrMoScl The scale that assesses the participant's degree of independence during bowel management within the last three months. The scale that assesses the participant's degree of independence during bowel management within the last three months. Degree of independency during bowel management (within the last three months): Requires total assistance;Requires partial assistance, does not clean self;Requires partial assistance, cleans self independently;Uses toilet independently in all tasks but needs adaptive devices or special setting (e.g. bars);Uses toilet independently, does not need adaptive devices or special setting;Unknown Requires total assistance;Requires partial assistance, does not clean self;Requires partial assistance, cleans self independently;Uses toilet independently in all tasks but needs adaptive devices or special setting (e.g. bars);Uses toilet independently, does not need adaptive devices or special setting;Unknown Alphanumeric

Choose one

The codes used are identical to those used in the Spinal Cord Independence Measure III (SCIM III) (Catz 2007). Catz A, Itzkovich M, Tesio L, Biering-S&Oslash;rensen F, Weeks C, Laramee MT, Craven BC, Tonack M, Hitzing SL, Glaser E, Zeilig G, Aito S, Scivoletto G, Mecci M, Chadwick RJ, El Marsy WS, Osman A, Glass CA, Silva P, Soni BM, Gardner BP, Savic G, Bergstrom EM, Bluvshtein V, Ronen J. A multicenter international study on the spinal cord independence measure; version III: Rasch psychometric validation. Spinal Cord 2007;45(4):275-91. 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

C06428 Spinal column injury extent type SpnlColmInjExntTyp In the presence of an injury through the spine, this element documents whether there is a single level spinal column injury or if there are multiple levels involved In the presence of an injury through the spine, this element documents whether there is a single level spinal column injury or if there are multiple levels involve Single or multiple spinal column level injury (-ies) Single;Multiple;Unknown Single;Multiple;Unknown Alphanumeric

Choose one

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

C06017 Bladder empty method supplementary type BladEmpMethdSuppTyp Supplementary type(s) of bladder emptying method(s) Supplementary type(s) of bladder emptying method(s) Bladder emptying Bladder expression;Bladder reflex triggering;External compression bladder expression;Indwelling catheter;Intermittent catheterisation;Intermittent catheterisation by attendant;Intermittent self-catheterisation;Involuntary bladder reflex triggering;Non-continent urinary diversion/ostomy;Normal voiding;Other method, specify;Sacral anterior root stimulation;Straining bladder expression;Suprapubic;Suprapubic indwelling catheter;Transurethral indwelling catheter;Unknown;Voluntary bladder reflex triggering Comprises various manoeuvres aimed at increasing intravesical pressure in order to facilitate bladder emptying. The most commonly used manoeuvres are abdominal straining, Valsalva's manoeuvre and CredÉ manoeuvre (Abrams et al. 2002).;Comprises various manoeuvres performed by the individual with spinal cord lesion or an attendant in order to elicit reflex detrusor contraction by exteroceptive stimuli. The most commonly used manoeuvres are suprapubic tapping, thigh scratching and anal/rectal manipulation (Abrams et al. 2002).;Includes CredÉ manoeuvre.;An indwelling catheter remains in the bladder, urinary reservoir or urinary conduit for a period of time longer than one emptying (Abrams et al. 2002).;Is defined as drainage or aspiration of the bladder or urinary reservoir/continent urinary diversion with subsequent removal of the catheter.;Is performed by an attendant (e.g. family member or personal aid);Is performed by the individual with spinal cord lesion himself/herself;Implies that there is no voluntary triggering of the voiding, but the individual with spinal cord lesion just let the urine run by itself when the reflex detrusor contraction occur by itself.;Non-continent urinary diversion/ostomy;Voluntary initiation of micturition without reflex stimulation or compression of the bladder. This does not presume entirely normal function (Levi and Ertzgaard 1998).;Other method, specify;Sacral anterior root stimulation;Includes abdominal straining, Valsalva's manoeuvre.;Suprapubic;indicates, that the urine is drained through a catheter via the abdominal wall.;Indicates, that the urine is drained through a catheter placed in the urethra.;Unknown;Indicates that the bladder reflex is triggered by the spinal cord lesioned individual him/herself or by the attendant. Alphanumeric

For each method of bladder emptying, indicate whether this is a main or a supplementary method. Two main and more supplementary methods may be indicated (adopted from Levi and Ertzgaard 1998).

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. 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. 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

Single Pre-Defined Value Selected

C18795 Cardiovascular function after last three month other text CardioFuncAfterLast3MnthOTH The free-text field related to 'Cardiovascular function after last three month type' specifying other text. Types of cardiovascular function that may have occurred after the spinal cord lesion (within three months) The free-text field related to 'Cardiovascular function after last three month type' specifying other text. Types of cardiovascular function that may have occurred after the spinal cord lesion (within three months Other, specify Alphanumeric Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations 4000

Free-Form Entry

C19477 Pressure ulcer first appearance date and time PressrUlcFrstApprncDateTime Date and time of first appearance of pressure ulcer Date and time of first appearance of pressure ulcer Ulcer appearance date/time 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.).

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 2014-06-17 11:01:29.0 Clinical Assessment Physical Examinations Assessments and Examinations

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C06249 Cardiovascular function after last three month type CardioFnctnAfterLast3MnthTyp Types of cardiovascular function that may have occurred after the spinal cord lesion (within three months) Types of cardiovascular function that may have occurred after the spinal cord lesion (within three months Cardiovascular function after spinal cord lesion within the last three months Autonomic dysreflexia;Cardiac conditions, specify;Dependent oedema;Hypertension;None;Orthostatic hypotension;Other,specify;Unknown (any cardiovascular disorder) Autonomic dysreflexia;Cardiac conditions, specify;Dependent oedema;Hypertension;None;Orthostatic hypotension;Other, specify;Unknown (any cardiovascular disorder) Alphanumeric

For each type of cardiovascular function after spinal cord lesion record whether it was experienced by the participant within the last three months.
Cardiac conditions: Subjective symptoms related to the heart that occur post-spinal cord lesion should be documented (e.g. abnormal heart rates/rhythm, angina, palpitation etc.).
Orthostatic hypotension: Symptomatic or asymptomatic decrease in blood pressure usually exceeding 20 mmHg systolic or 10 mmHg diastolic on moving from the supine to an upright position.
Dependent oedema: A clinically detectable increase in extracellular fluid volume localized in a dependent area, such as a limb, characterized by swelling or pitting.
Hypertension: (arterial blood pressure >140/90 mmHg). The diagnosis of hypertension in individual with SCI should be considered after careful monitoring and documentation of the level of arterial blood pressure and exclusion of possible elevation of BP due to episodes of AD.
Autonomic dysreflexia: A constellation of signs and/or symptoms in SCI above T5-6 spinal cord segments in response to noxious or non-noxious stimuli below the level of injury defined by an increase in systolic blood pressure (> 20mm Hg above baseline), and which may include one of the following symptoms: headache, flushing and sweating above the level of the lesion, vasoconstriction below the level of the lesion, and dysrhythmia. This syndrome may or may not be symptomatic and may occur at any time following SCI.

Consensus statement on the definition of orthostatic hypotension, pure autonomic failure, and multiple system atrophy. The Consensus Committee of the American Autonomic Society and the American Academy of Neurology. Neurol. 46, 1470 (1996). Gao,S.A., Ambring,A., Lambert,G. & Karlsson,A.K. Autonomic control of the heart and renal vascular bed during autonomic dysreflexia in high spinal cord injury. Clin. Auton. Res. 12, 457-464 (2002). Karlsson,A.K., Friberg,P., Lonnroth,P., Sullivan,L. & Elam,M. Regional sympathetic function in high spinal cord injury during mental stress and autonomic dysreflexia. Brain 121, 1711-1719 (1998). Kirshblum,S.C., House,J.G. & O'connor,K.C. Silent autonomic dysreflexia during a routine bowel program in persons with traumatic spinal cord injury: a preliminary study. Arch. Phys. Med. Rehabil. 83, 1774-1776 (2002). Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-S&Oslash;rensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Krassioukov,A. & Claydon,V.E. The clinical problems in cardiovascular control following spinal cord injury: an overview. Prog. Brain Res. 152, 223-229 (2006). Krassioukov,A.V., Furlan,J.C. & Fehlings,M.G. Autonomic dysreflexia in acute spinal cord injury: an under-recognized clinical entity. J. Neurotrauma 20, 707-716 (2003). Linsenmeyer,T.A., Campagnolo,D.I. & Chou,I.H. Silent autonomic dysreflexia during voiding in men with spinal cord injuries. J. Urol. 155, 519-522 (1996). Mathias,C.J. & Frankel,H.L. Autonomic Failure, A Textbook of Clinical Disorders of the Autonomic Nervous System. Bannister,R. & Mathias,C.J. (eds.), pp. 839-881 (Oxford Medical Publications,2002). Pickering,T.G. et al. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circula. 111, 697-716 (2005). Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Clinical Assessment Physical Examinations Assessments and Examinations

Multiple Pre-Defined Values Selected

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