CDE Detailed Report

Disease: Multiple Sclerosis
Sub-Domain: Physical/Neurological Examination
CRF: Physical Exam

Displaying 1 - 9 of 9
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
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 participant/subject Yes;No Yes;No 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/Neurological Examination 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) 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/Neurological Examination Assessments and Examinations 255

Free-Form Entry

C18666 Body system other text BodySysOTH The free-text field related to 'Body system category' specifying other text. 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 Free-text 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. Other, specify Alphanumeric

Record the appropriate body system for each line of medical history. Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. For TBI: Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history. For SCI: Record all pulmonary conditions present before spinal cord lesion. For ALS: Each body system is pre-populated on the case report form. Record the physical exam results for each. The 'Neurological' body system should only be used to record physical examination findings separate from the ALS exam.

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. 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. 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 1.00 2014-05-27 13:34:46.0 Physical Exam Physical/Neurological Examination Assessments and Examinations 4000

Free-Form Entry

2002895
C00023 Hand preference type HandPrefTyp Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively. Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively. Hand preference Left hand;Right hand;Both hands;Unknown Left hand;Right hand;Both hands;Unknown Alphanumeric

Choose one - the hand which the participant/subject uses predominantly, not necessarily the hand the participant/subject writes with exclusively Choose the hand which the participant/subject uses predominantly, not necessarily the hand the participant/subject writes with exclusively. Unknown should be used in the scenario for infants or other (rare) instances when handedness can not be known or is not yet developed.

ALS reference: Shefner J, Cudkowicz ME, Maragakis N, Cedarbaum JM, Lee J, Jones D, Watson ML, Shaver K, Chen M, Saikali K, Mao J, Russell AK, Hansen L, Malik F, Wolff AA, for the NEALS/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in Amyotrophic Lateral Sclerosis. (submitted for publication) Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Physical Exam Physical/Neurological Examination Assessments and Examinations

Single Pre-Defined Value Selected

2180147
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);Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Genitourinary;Hematologic/Lymphatic;Integumentary (skin and/or breast);Musculoskeletal;Neurological;Psychiatric;Respiratory Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Genitourinary;Hematologic/Lymphatic;Integumentary (skin and/or breast);Musculoskeletal;Neurological;Psychiatric;Respiratory Alphanumeric

Record the appropriate body system for each line of medical history. Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. For TBI: Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history. For SCI: Record all pulmonary conditions present before spinal cord lesion. For ALS: Each body system is pre-populated on the case report form. Record the physical exam results for each. The 'Neurological' body system should only be used to record physical examination findings separate from the ALS exam.

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. 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. 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/Neurological Examination 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. 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.).

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Physical Exam Physical/Neurological Examination 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 examined Abnormal;Normal;Not examined 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/Neurological Examination 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.

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/Neurological Examination 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/Neurological Examination Assessments and Examinations

Single Pre-Defined Value Selected

3180087
CSV