CDE Detailed Report

Disease: Multiple Sclerosis
Sub-Domain: Vital Signs and Other Body Measures
CRF: Vital Signs

Displaying 1 - 16 of 16
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C01541 Weight measurement WgtMeasr Measurement of participant's/subject's weight Measurement of participant's/subject's weight Weight Numeric Values

Record the weight of the participant/subject. To be collected at the visit, not self-reported. Also, indicate whether weight was measured in pounds (lbs) or kilograms (kg).

Bauman WA, Biering-SØrensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Bauman WA, Spungen AM. Endocrinology and metabolism of persons with spinal cord injury. In Spinal Cord Medicine. (S. Kirshblum, D.I. Campagnolo, and J. DeLisa, ed.) Lippincott Publications, New York, NY. 2002, pp. 164-180. Bauman WA, Spungen AM. Carbohydrate and lipid metabolism in chronic spinal cord injury. J Spinal Cord Med 2001: 24: 266-277. Laughton GE, Buchholz AC, Martin Ginis KA, Goy RE, SHAPE SCI Research Group. Lowering body mass index cutoffs better identifies obese persons with spinal cord injury. Spinal Cord 2009; 47: 757-762. Spungen AM, Adkins RH, Stewart CA, Wang J, Pierson RN, Waters RL, Kemp BJ, Bauman WA. Factors influencing body composition in persons with spinal cord injury: A cross-sectional study. J Amer Physiol 2003; 95: 2398-2407. Weaver FM, Collins EG, Kurichi J, Miskevics S, Smith B, Rajan S, Gater D. Prevalence of obesity and high blood pressure in veterans with spinal cord injuries and disorders: a retrospective review. Am J Phys Med Rehabil 2007; 86:22-29. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 500 kilogram 2179689
C01550 Temperature measurement anatomic site TempMeasrAntmicSite Anatomic site on or within the body where the temperature was measured. Anatomic site on or within the body where the temperature was measured. Temperature Method Oral;Rectal;Tympanic;Axillary;Forehead Cutaneous Infrared;Other, specify Oral;Rectal;Tympanic;Axillary;Forehead Cutaneous Infrared;Other, specify Alphanumeric

Choose one. Record the location where the temperature was measured. This element is most relevant to pediatric clinical studies.

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; 50(7):512-6. Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

3151195
C01553 Blood pressure measurement position type BldPressrMeasrPositionTyp Indicator of the participant/subject's position during the blood pressure measurement. Indicator of the participant/subject's position during the blood pressure measurement. Participant's/Subject's Position Sitting;Standing;Supine Sitting;Standing;Supine Alphanumeric

Record the position the participant/ subject was in when the blood pressure was measured. Choose one. Cardiovascular parameters are affected by the position of the individual during the testing. For example blood pressure could decrease due to sitting or standing position. Therefore it is important to document the individual's position during testing.

Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Sidorov,E.V. et al. Orthostatic hypotension in the first month following acute spinal cord injury. Spinal Cord (2007). Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

2008432
C01507 Blood pressure diastolic measurement BldPressrDiastlMeasr Measurement of pressure of the participant's/subject's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's/subject's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Blood Pressure Numeric Values

Record the diastolic blood pressure of the participant/ subject. The standard unit for measuring blood pressure is mmHg, which is approximately equivalent to Torr. Record blood pressure from the blood pressure monitor or measure manually by sphygmanometry. The suggested range is 0-300 mmHg. Add date stamp for when assessed. When hourly values are documented, we recommend to take readings at a fixed time point, for example the last minute of the hour. Exclude values which may be influenced by artifacts. Add date stamp for when assessed. The injured brain is often not able to pressure autoregulate normally, adequate perfusion may be more dependent on perfusion pressure; lower blood pressure and low perfusion pressure can aggravate ischemic damage to the injured brain whilst conversely a high blood pressure may lead to increased intracranial pressure and carries an increased risk of neurogenic lung edema. Hypotensive episodes before and after admission adversely affect outcome. In patients with severe traumatic brain injury, routine calculation of the cerebral perfusion pressure on an hourly basis is recommended. Pediatric-specific notes: As a minimum, vital signs should be recorded on admission and further, on a daily basis during the acute phase after injury. For the basic datasets, we recommend recording the average and lowest blood pressure over a given period. In the ICU environment, recording blood pressure on an hourly basis is recommended, especially when intracranial pressure (ICP) is monitored in order to permit determination of CPP, calculated as mean arterial blood pressure (MABP) – ICP (intermediate data set).

Management and prognosis of severe traumatic brain injury, J Neurotrauma 2000;17:591-595.; Butcher I, Maas AI, Lu J , et al. Prognostic value of admission blood pressure in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):294-302. Murray GD, Butcher I, McHugh GS, et al. Multivariate prognostic analysis in traumatic brain injury. J Neurotrauma. Feb 2007;24(2):329-377. Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Mathias,C.J. & Frankel,H.L. Handbook of Clinical Neurology. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 300 millimeter of mercury 2004291
C01565 Blood pressure systolic measurement BldPressrSystMeasr Measurement of pressure of the participant's/subject's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's/subject's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) Blood Pressure Numeric Values

Record the systolic blood pressure of the participant/ subject. The standard unit for measuring blood pressure is mmHg, which is approximately equivalent to Torr. Record blood pressure from the blood pressure monitor or measure manually by sphygmanometry. The suggested range is 0-300 mmHg. Add date stamp for when assessed.When hourly values are documented, we recommend to take readings at a fixed time point, for example the last minute of the hour. Exclude values which may be influenced by artifacts. The injured brain is often not able to pressure autoregulate normally, adequate perfusion may be more dependent on perfusion pressure; lower blood pressure and low perfusion pressure can aggravate ischemic damage to the injured brain whilst conversely a high blood pressure may lead to increased intracranial pressure and carries an increased risk of neurogenic lung edema. Hypotensive episodes before and after admission adversely affect outcome. In patients with severe traumatic brain injury, routine calculation of the cerebral perfusion pressure on an hourly basis is recommended. Pediatric-specific notes: This element is recommended for pediatric studies. As a minimum, vital signs should be recorded on admission and further, on a daily basis during the acute phase after injury. For the basic datasets, we recommend recording the average and lowest blood pressure over a given period. In the ICU environment, recording blood pressure on an hourly basis is recommended, especially when intracranial pressure (ICP) is monitored in order to permit determination of CPP, calculated as mean arterial blood pressure (MABP) – ICP (intermediate data set).

Management and prognosis of severe traumatic brain injury, J Neurotrauma 2000;17:591-595. Butcher I, Maas AI, Lu J , et al. Prognostic value of admission blood pressure in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):294-302. Murray GD, Butcher I, McHugh GS, et al. Multivariate prognostic analysis in traumatic brain injury. J Neurotrauma. Feb 2007;24(2):329-377. Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Mathias,C.J. & Frankel,H.L. Handbook of Clinical Neurology. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 300 millimeter of mercury 2004289 C25298
C01519 Vital signs date and time VitalSgnDateTime Date (and time, if applicable and known) the vital signs and other body measurements were taken by indicating the month, day, and year for the date and am, pm, or 24 hour clock for time Date (and time, if applicable and known) the vital signs and other body measurements were taken by indicating the month, day, and year for the date and am, pm, or 24 hour clock for time Date and Time Date or Date & Time

Record the date vital signs are taken. 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-SØrensen F. International Spinal Cord Injury Skin and Thermoregulation Function Basic Data Set. Spinal Cord. 2012; 50(7):512-6. Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

2829808
C01580 Temperature unit of measure TempUOM Unit of measure for the temperature numerical value Unit of measure for the temperature numerical value Temperature F;C degrees Fahrenheit;degrees Celsius Alphanumeric

Choose either F (degrees Fahrenheit) or C (degrees Celsius). Record the scale used to measure the temperature - choose one. Degrees Celsius is the preferred scale for measuring temperature.

Unified Code for Units of Measure - http://unitsofmeasure.org/ 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; 50(7):512-6. Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

2956267
C01520 Head circumference measurement HeadCircumfMeasr Circumferential measurement of the head at the widest point - the distance from above the eyebrows and ears and around the back of the head Circumferential measurement of the head at the widest point - the distance from above the eyebrows and ears and around the back of the head Head Circumference Numeric Values

Record the head circumference of the participant/ subject as well as the units for the measurement. Measurement must be done prior to any neurosurgical intervention and if there is soft tissue swelling it needs to be clearly noted that an enlarged Occipitofrontal circumference (OFC) due to STS is not the same as an enlarged OFC without STS. Abnormalities in OFC may identify children who were not neurologically normal at the time of injury in acute injury studies or serve as a baseline for following developmental outcome in studies with longer follow up.

Pryor H and Thelander H. (1968). Abnormally small head size and intellect in children J Pediatr. 73:593-598. Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

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0 100 centimeter 3181613
C01581 Weight unit of measure WgtUoM Unit of measure for the weight numerical value Unit of measure for the weight numerical value Weight measurement Pounds;Kilograms Pounds;Kilograms Alphanumeric

Choose either Pounds (lb) or Kilograms (kg).

Unified Code for Units of Measure - http://unitsofmeasure.org/ Bauman WA, Biering-SØrensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

2630200
C01521 Heart rate HeartRate The participant/subject's pulse or number of contractions (heart beats) per minute The participant/subject's pulse or number of contractions (heart beats) per minute Heart Rate/Pulse Numeric Values

Record the pulse of the participant/ subject in beats per minute. Record heart rate from monitor or by counting pulse rate. The suggested range is 0-300. Add date stamp for when assessed. Heart rate may be altered by trauma in a couple of ways. Tachycardia may indicate volume depletion, pain or stress, and higher heart rates have been found in patients that do not survive traumatic injuries. Bradycardia may be seen with elevated intracranial pressure. Pediatric-specific notes: As a minimum, vital signs should be recorded on admission and further, on a daily basis during the acute phase after injury. For the basic datasets, we recommend recording the average and lowest blood pressure over a given period. In the ICU environment, recording blood pressure on an hourly basis is recommended, especially when intracranial pressure (ICP) is monitored in order to permit determination of CPP, calculated as mean arterial blood pressure (MABP) – ICP (intermediate data set). Resting BP and HR should be obtained following empting of the bladder and 5 minutes of resting period. Both physical activities and full urinary bladder could affect these parameters.

Shoemaker WC, Bayard DS, Botnen A, et al. Mathematical program for outcome prediction and therapeutic support for trauma beginning within 1 hr of admission: a preliminary report. Crit Care Med. Jul 2005;33(7):1499-1506. Agrawal A, Timothy J, Cincu R, et al. Bradycardia in neurosurgery. Clin Neurol Neurosurg. Apr 2008;110(4):321-7. Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Lehmann,K.G., Shandling,A.H., Yusi,A.U. & Froelicher,V.F. Al Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 300 beats per minute 2767073
C01582 Height unit of measure HgtUOM Unit of measure for the height numerical value for subject/participant Unit of measure for the height numerical value for subject/participant Height/Length Inches;Centimeters Inches;Centimeters Alphanumeric

Choose either Inches (in) or Centimeters (cm).

Unified Code for Units of Measure - http://unitsofmeasure.org/ Bauman WA, Biering-SØrensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Lipton RL, et al. Prevalence and burden of Migraine in the United States: Data from the American Migraine Study II. Headache. 2001; 41: 646-657. Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

2538920
C01522 Height measurement HgtMeasr Measurement of participant's/subject's height. Measurement of participant's/subject's height. Height/Length Numeric Values

Record the height (or length for the very young) of the participant/ subject. To be collected at the visit, not self-reported. Also, indicate whether height was measured in inches (in) or centimeters (cm). The suggested range is 0-500 cm or 0-100 inches. Height and weight can be measured or estimated upon admission, or alternatively information may be obtained from relatives. Add date stamp for when assessed. Documentation of height and weight is motivated by two reasons: 1. the risk of (systemic) complications is greater in the presence of obesity; 2. body weight is important for calculating required doses of (study) medications. For Headache: Completed by each member of your household who suffers from severe headaches.

Bauman WA, Biering-SØrensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. Bauman WA, Spungen AM. Endocrinology and metabolism of persons with spinal cord injury. In Spinal Cord Medicine. (S. Kirshblum, D.I. Campagnolo, and J. DeLisa, ed.) Lippincott Publications, New York, NY. 2002, pp. 164-180. Bauman WA, Spungen AM. Carbohydrate and lipid metabolism in chronic spinal cord injury. J Spinal Cord Med 2001: 24: 266-277. Laughton GE, Buchholz AC, Martin Ginis KA, Goy RE, SHAPE SCI Research Group. Lowering body mass index cutoffs better identifies obese persons with spinal cord injury. Spinal Cord 2009; 47: 757-762. Spungen AM, Adkins RH, Stewart CA, Wang J, Pierson RN, Waters RL, Kemp BJ, Bauman WA. Factors influencing body composition in persons with spinal cord injury: A cross-sectional study. J Amer Physiol 2003; 95: 2398-2407. Weaver FM, Collins EG, Kurichi J, Miskevics S, Smith B, Rajan S, Gater D. Prevalence of obesity and high blood pressure in veterans with spinal cord injuries and disorders: a retrospective review. Am J Phys Med Rehabil 2007; 86:22-29. Lipton RL, et al. Prevalence and burden of Migraine in the United States: Data from the American Migraine Study II. Headache. 2001; 41: 646-657. Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 400 centimeter 649
C18767 Temperature measurement other text TempMeasrOTH The free-text field related to 'Temperature measurement anatomic site' specifying other text. Anatomic site on or within the body where the temperature was measured. The free-text field related to 'Temperature measurement anatomic site' specifying other text. Anatomic site on or within the body where the temperature was measured. Other, specify Alphanumeric

Choose one. Record the location where the temperature was measured. This element is most relevant to pediatric clinical studies.

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; 50(7):512-6. Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations 4000

Free-Form Entry

3151195
C01523 Head circumference unit of measure HdCircumfUoM Unit of measure for the head circumference numerical value Unit of measure for the head circumference numerical value Head Circumference Inches;Centimeters Inches;Centimeters Alphanumeric

Choose only one unit. Choose either Inches (in) or Centimeters (cm).

Unified Code for Units of Measure - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

3181626
C01535 Respiratory rate RespRate Rate of the participant/subject's breathing (inhalation and exhalation). Rate of the participant/subject's breathing (inhalation and exhalation). Respiratory Rate Numeric Values

Record the respiratory rate of the participant/subject in breaths per minute. Add date stamp for when assessed. Hypoxia, hypercapnia, and hypocapnia have all been associated with poor outcome.

Davis, DP. Early ventilation in traumatic brain injury. Resuscitation. Mar 2008;76(3):333-340. Guidelines for the management of severe traumatic brain injury. XIV. Hyperventilation. J Neurotrauma. 2008;25:276-8. Murray GD, Butcher I, McHugh GS, et al. Multivariable prognostic analysis in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):329-337. Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 120 breaths per minute 2644399
C01539 Temperature measurement TempMeasr Measurement of the participant's/subject's body temperature. Measurement of the participant's/subject's body temperature. Temperature Numeric Values

Record the temperature of the participant/ subject. Also indicate the scale used to capture temperature. Pediatric-specific notes: As a minimum, vital signs should be recorded on admission and further, on a daily basis during the acute phase after injury. For the basic datasets, we recommend recording the average and lowest blood pressure over a given period. In the ICU environment, recording blood pressure on an hourly basis is recommended, especially when intracranial pressure (ICP) is monitored in order to permit determination of CPP, calculated as mean arterial blood pressure (MABP) – ICP (intermediate data set).

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; 50(7):512-6. Sund-Levander M, Forsberg C, Wahren LK : Normal oral, rectal, tympanic and axillary body temperature in adult men and women: a systematic literature review. Scand J Caring Sci. 2002 Jun;16: 122-8. Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 50 degree Celsius 2644401
CSV