CDE Detailed Report

Disease: Spinal Cord Injury
Sub-Domain: Physical Examinations
CRF: Physical Exam

Displaying 1 - 7 of 7
CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C01028 Physical exam condition SNOMED CT code PhysExamCondSNOMEDCTcode Medical condition/disease found during the physical examination of the participant/subject. Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT) Medical condition/disease found during the physical examination of the participant/subject. Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT) Describe Abnormality or Comment if Body System is Not Examined Alphanumeric

Code the description of each abnormal result found during the physical exam using the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT).

SNOMED CT CODES - Problem List (http://www.nlm.nih.gov/research/umls/Snomed/core_subset.html) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Physical Exam Physical Examinations Assessments and Examinations 255

Free-Form Entry

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

Each body system is pre-populated on the case report form.

Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf<br />International Data Sets References:<br />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.<br />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.<br />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<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.<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. <br />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.<br />International Standards for Neurological Classification of SCI Worksheet Used with permission of the American Spinal Injury Association: International Standards for Neurological Classification of Spinal Cord Injury, revised 2002: Atlanta, GA.<br />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 2013-07-25 08:54:08.2 Physical Exam Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

2002895
C01010 Physical exam date and time PhysExamDateTime Date (and time if applicable and known) physical exam was performed Date (and time if applicable and known) physical exam was performed Date of Exam Date or Date & Time

Record the date(and time) the physical exam was performed. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Physical Exam Physical Examinations Assessments and Examinations

Free-Form Entry

2004170
C01012 Physical exam body system result type PhysExamBodySysResltTyp Assessment result of each body system examined Assessment result of each body system examined Result Abnormal;Normal;Not assessed Abnormal;Normal;Not assessed Alphanumeric

Choose one. Indicate whether each body system examined had any abnormal findings.

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Physical Exam Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

2821383
C01013 Physical exam description text PhysExamDescripTxt Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined Describe Abnormality or Comment if Body System is Not Examined Alphanumeric

Provide a description of each abnormal result found during the physical exam, or provide an explanation of why the body system was not examined. See the data dictionary for additional information on coding the abnormality using the Systemized Nomenclature of Medicine-Clinical Terms(SNOMED CT).

SNOMED CT CODES - Problem List (http://www.nlm.nih.gov/research/umls/Snomed/core_subset.html) Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Physical Exam Physical Examinations Assessments and Examinations 255

Free-Form Entry

2201880
C01014 Physical exam abnormality significance type PhysExamAbnrmlySignfcnceTyp An indication if the physical exam abnormality in a specific body system is clinically significant An indication if the physical exam abnormality in a specific body system is clinically significant If Abnormality, Clinically Significant? Clinically Significant;Not Clinically Significant Clinically Significant;Not Clinically Significant Alphanumeric

Choose one. If the body system had an abnormal finding, record whether the abnormality is Clinically Significant. Any Abnormal, Clinically Significant finding at screening should be recorded on the Medical History as well.

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Physical Exam Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

3180087
C01015 Physical exam performed indicator PhysExamPerfrmdInd Indicator of whether a physical exam was performed on the participant/subject Indicator of whether a physical exam was performed on the participant/subject Was a physical exam performed on the patient/participant? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. Specify whether or not a physical exam was performed on the participant/subject.
If an abnormal result, please complete the corresponding International SCI Data Set elements, which are listed on the Clinical Assessment Form (F1716).

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Physical Exam Physical Examinations Assessments and Examinations

Single Pre-Defined Value Selected

2201750
CSV