CDE Detailed Report
Disease: Spinal Cord Injury
Subdomain Name: Physical Examinations
CRF: Physical Exam
Displaying 1 - 7 of 7
Subdomain Name: 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 / 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. |
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 | |||||||
| 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 |
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| C00312 | Body system category | BodySysCat | Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems | Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body system | Body System | Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);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-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90.<br />Biering-SØrensen F, Krassioukov A, Alexander MS, Donovan W, Karlsson AK, Mueller G, Perkash I, William Sheel A, Wecht J, Schilero GJ.International Spinal Cord Injury Pulmonary Function Basic Data Set. Spinal Cord. 2012 Jun; 50(6):418-21.<br />Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4<br />Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30.<br />Biering-SØrensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW, Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic data set. Spinal Cord. 2012 Nov;50(11):797-802. <br />Karlsson AK, Krassioukov A, Alexander MS, Donovan W, Biering-SØrensen F. International spinal cord injury skin and thermoregulation function basic data set. Spinal Cord. 2012 Jul;50(7):512-6.<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-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 | 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 |
