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 interview and physical examination of all the body systems.

FITBIR|PDBP; 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

ALS/DMD/EPILEPSY/FA/GENERAL/HEADACHE/MG/NMD/SMA/STROKE/TBI: 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 MS: 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, Bieringarensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8): 586-90. Bauman WA, Bieringensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10): 1068-72. SCI: Bauman WA, Biering-Sýrensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10): 1068-72. Biering-Sýrensen 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. Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-Sýrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8): 586-90.

Record the appropriate body system for each line of medical history. Each body system is pre-populated on the case report form. TBI: 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 enrolment or later. 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.

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NIH/NINDS

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NIH/NINDS

NINDSCDE

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