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

Body system category

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 Farensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8): 586-90. Bauman WA, Bieringarensen Farensen 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, Bieringarensen Farensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10): 1068-72. Bieringarensen Farensen 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, Bieringarensen Farensen 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/ TBIACUTE/ TBIEPID/ TBIMOD/ TBIMILDChoose 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. SCI: Record the cardiovascular history before the spinal cord lesion. Record all pulmonary conditions present before spinal cord lesion. FA: Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus of this study. Use only one line per description.; Each body system is pre-populated on the case report form. Record the physical exam results for each. ALS/NMD/SMARecord the appropriate body system for each line of medical history. Each body system is pre-populated on the case report form. MG: Each body system is pre-populated on the case report form. Record the code number associated with the appropriate body system for each line of medical history. The numeric codes are provided for studies that will record the data on paper CRFs. In a database the body system can be used without the numeric codes. EPILEPSY: 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. STROKE: Record the appropriate body system for each line of medical history. MS: 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 enrolment 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. Each body system is pre-populated on the case report form.

Body system category

Mon Jul 31 13:04:57 EDT 2023

NIH/NINDS

NINDSCDE

NINDSCDE@emmes.com

NIH/NINDS

NINDSCDE

NINDSCDE@emmes.com