LABORATORY TEST FORM
LABORATORY TEST FORMYou are allowed to remove any questions that are non-core questions with associated permissible values. You are NOT allowed to insert/delete permissible values of existing questions. The variable name in FITBIR is underlined. The core questions are indicated by a red asterisk.Main groupStudy Name:*GUID (GUID):Subject ID number (SubjectIDNum):Age in Years (AgeYrs):Visit Date (VisitDate):Site Name (SiteName):Days since Baseline (DaysSinceBaseline): ____________________Case Control Indicator (CaseContrlInd):Case Control Unknown What is the vital status of the subject? (VitStatus):O Alive Dead UnknownForm administrationWhat is the ISO 639 code for the language the form/instrument has been administrated? (LangCRFAdministratISOCode). Select one. If “Other, specify” is selected, please write in response.chiChineseczeCzechdanDanishdutDutchengEnglishfinFinnishfreFrenchgerGermangreGreekhebHebrewhinHindihunHungarianiraIranian languages itaItalianjpnJapanesenorNorwegianporPortugueserusRussiansgnSign languagespaSpanishvieVietnamese Other, specify_____________________ (LangCRFAdministratISOCodeOTH)What time frame do the questions in this form refer to? (ContextType)Select one. If “Other, specify” is selected, please write in response.After injury At time of assessment Time of injury Before injury Last 2 weeks Last 6 months Last 24 hours Last month Last week Last year Prior to death Since last interview Other, specify (ContextTypeOTH) ____________________Form administrationWho filled out this form? (DataSource)Select one. If “Other, specify” is selected, please write in response. Participant/Subject Spouse Father Mother Son Daughter Brother Sister Friend Physician Chart/Medical Record Other, specify (DataSourceOTH) ____________________Laboratory TestsWas the laboratory test performed?LabTestPerfIndChoose oneYesNoUnknownLOINC code of the laboratory testLabTestLOINCCodeCode the laboratory test that is run on the specimen using Logical Observation Identifiers Names and Codes (LOINC) - and time the lab test was completed/performedLabTestDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)_____________________________Specify whether the lab test date and time is accurately recorded or estimated.LabTestDateTimeRecTypChoose oneAccurateEstimatedSelf-reportedUnknownSpecify the reason why of whether the lab test date and time is unknown or estimated.LabTestDateTimeUnknownRsn. Choose one.UnknownNot AvailableNot sure/Cannot rememberResponse declinedRecord the date the lab specimen was collected.LabSpecmnCollDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)___________Lab specimen type:LabSpecmnTypSelect one. If “Other, specify” is selected, please write in response. Amniotic fluidArterial blood - buffy coat Arterial blood – plasmaArterial blood - platelets Arterial blood – serumArterial blood - whole Blood Brain tissue Bronchial lavageBuccal swab Catheter tip Cerebral spinal fluidGastric aspirateNasal Newborn cord blood PlacentaSalivaSputumStoolThroatUrineVenous blood - buffy coat Venous blood - plasma Venous blood - platelets Venous blood - serum Venous blood- wholeWound swabOther, specify (LabSpecmnOTH)____________________What is the name of the Lab Test?LabTestNameIndicate the name of each laboratory test that is run on the specimen. See the data dictionary for additional information on coding the test name using Logical Observation Identifiers Names and Codes (LOINC). Select all that apply If “Other, specify” is selected, please write in response. 8-isoprostanes8-OH-2-deoxyguanosineActivated PTT(aPTT)Alanine Aminotransferase (ALT/ALAT/SGPT)AlbuminAlbumin: globulin(A:G)ratioAlcoholAlkaline PhosphataseAmylaseAnion GapApolipoprotein B (apo B)Apolipoprotein E (apo E)Apolipoprotein-I (apo A1)Arterial blood gas bicarbonate(HCO3)Arterial blood gas fraction of inspired oxygen(FiO2)Arterial blood gas partial pressure carbon dioxide (pCO2)Arterial blood gas partial pressure oxygen(pCO2)Arterial blood gas PH(pH)Arterial blood TemperatureAspartate Aminotransferase(AST/ASAT/SGOT)Base Excess(BE)Basophils %Bicarbonate (HCO3)Blood Urea Nitrogen (BUN)B-type natriuretic peptide (BNP)BUN: creatinine ratioCalcium (Ca)Carbon Dioxide (CO2)Chloride (Cl)CortisolC-Reactive ProteinWhat is the name of the Lab Test? ContinuedLabTestNameCreatine KinaseCreatine Kinase-Myocardial Bands (CK-MB)CreatinineD-dimerDirect BilirubineGFR calculationEosinophil CountEosinophils %Fasting GlucoseFasting InsulinFerritinFibrinogenFrataxin LevelGAA repeat-expansion mutationGamma-glutamyl transpeptidase (GGT)Globulin, totalGlucoseGlucose D-stickGlucose serumGlycosylated Hemoglobin (HgBA1C)Hematocrit (HCT)Hemoglobin ElectrophoresisHemoglobin (HB)High Density Lipoprotein (HDL)HIV testInternational Normalized Ratio (INR)Ionized CalciumIronLactateLactate Dehydrogenase (LDH)LipaseLipoprotein (a) [Lp(a)]Low Density Lipoprotein (LDL)Lymphocyte CountWhat is the name of the Lab Test? ContinuedLabTestNameLymphocyte %Magnesium (Mg)Mean corpuscular hemoglobin concentration(MCHC)Mean corpuscular volume(MCV) Monocyte CountMonocyte %Neutrophil %Neutrophil CountOral glucose toleranceOsmolality, serumPartial Thromboplastin Time (PTT)PhenobarbPhenytoinPhosphate (PO4)pH valuePlasma malondialdehydePlatelet CountPotassium (K)Pre-AlbuminProthrombin Time (PT)Red cell distribution Serum N-terminal atrial natriuretic peptide (ANP-N)Sodium (Na)Specific Gravity(Urine)Sulfur Dioxide(SO2)Total BilirubinTotal Cholesterol (TCHOL)Total Iron Binding Capacity(TIBC)Total Protein Triglycerides (TGs)Troponin ITroponin TUreaUrine 8-OH-2-deoxyguanosine/creatinine ratioWhat is the name of the Lab Test? ContinuedLabTestNameUrine CreatinineUrine NitriteUrine pHVenous blood gas fraction of inspired oxygen(FiO2)Venous blood gas partial pressure carbon dioxide(pCO2)?Venous blood gas partial pressure oxygen(PO2)Venous Blood TemperatureVery Low Density Lipoprotein (VLDL)Vitamin B12Vitamin EWhite Blood Cell Count (WBC)Whole Blood TemperatureOther, specify (LabTestOTH)____________________Result of the laboratory testLabTestResltValRecord the numeric or alpha-numeric results for each laboratory test.________________________________________________Unit of measureLabTestResltUoMRecord the units the numeric results for each laboratory test are measured in. See the data dictionary for additional information on coding the unit of measure using Unified Coed for Units of Measure (UCUM)________________________________________________Where there any medication(s) present during lab test:LabTestMedctnIndChoose oneYesNoUnknownName of medication(s) present during lab testLabTestMedctnName Record each medication______________________________________________________________________________________________Lab test result unit of measure UCUM code?LabTestResltUoMUCUMCodeRecord the units the numeric results for each laboratory test are measured in. See the data dictionary for additional information on coding the unit of measure using Unified Code for Units of Measure (UCUM)_____________________________________________________________Laboratory test lowest range value:LabTestLowRangeValRecord the lowest value and the unit of measure if known.___________________________Laboratory test highest range valueLabTestHighRangeValRecord the highest value and the unit of measure if known._______________________________________Was test result abnormal? LabTestResltStatusChoose oneAbnormalNormalUnknownIf abnormal, clinically significant?LabTestAbnrmlySignfcnceTypChoose oneClinically SignificantNot Clinically SignificantWhat is the result of the antibody laboratory test?LabTestAntibodyResltChoose oneNegative Positive, TiterWas participant fasting prior to specimen collection?FastBeforeLabTestIndChoose oneYesNoUnknownType of location where the data were taken/recorded.DataAcquisitionLocationTypChoose one. If “Other, specify” is selected, please write in response.Acute Care UnitAmbulatoryAssisted LivingCentral Lab Clinic/MD OfficeCritical Access Hospital Critical Care Unit CT-AngioDischarge LoungeED arrivalED dischargeED-Non-trauma Center ED post-resuscitation ED-Trauma CenterFollow-up visitHigh Care UnitHomeHospiceICUImaging Diagnostic DepartmentInjury sceneInpatient Epilepsy Monitoring UnitInpatient RehabIntermediate Care UnitLong Term Care HospitalNursing HomeObservation UnitOROther HospitalOutpatient ClinicOutpatient EEG labPre-hospitalPre-hospital BestPre-hospital WorstReferring HospitalRehabilitation UnitSite LabStep-Down UnitSupervised LivingUnknownUrgent CareWardOther, specify (DataAcquisitionLocationOTH)____________________Comments on the laboratory test:LabTestCommentWrite comments if any:____________________________________________Is the subject taking any non-study medications?MedctnPriorConcomUseInd Choose one. If this question is answered YES then at least one prior/current medication record needs to be recorded. Do NOT record study medications taken (if study has a drug intervention) on this form. YesNoUnknownMedication name (trade of generic)MedctnPriorConcomNameRecord the verbatim name (generic or trade name) of the medication the participant/subject reports taking. See the data dictionary for additional information on coding the medication name using RXNorm. Add date stamp for when assessed. Recommend collection at least on date of TBI.______________________________________________________________Is the concomitant medication use ongoing?MedctPrConcomOngoingIndChoose one. Answer YES if the participant/subject is still taking the medication or NO if the participant/subject has stopped taking the medication.YesNoUnknown ?BLOOD TYPINGWas the laboratory test performed?LabTestPerfIndChoose oneYesNoUnknownLOINC code of the laboratory testLabTestLOINCCodeCode the laboratory test that is run on the specimen using Logical Observation Identifiers Names and Codes (LOINC) - and time the lab test was completed/performedLabTestDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)_____________________________Specify whether the lab test date and time is accurately recorded or estimated.LabTestDateTimeRecTypChoose oneAccurateEstimatedSelf-reportedUnknownSpecify the reason why of whether the lab test date and time is unknown or estimated.LabTestDateTimeUnknownRsn. Choose one.UnknownNot AvailableNot sure/Cannot rememberResponse declinedRecord the date the lab specimen was collected.LabSpecmnCollDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)___________Lab specimen type:LabSpecmnTypChoose one. If “Other, specify” is selected, please write in response. Arterial blood - buffy coat Arterial blood – plasmaArterial blood - platelets Arterial blood – serumArterial blood - whole BloodVenous blood gas fraction of inspired oxygen(FiO2)Venous blood gas partial pressure carbon dioxide(pCO2)?Venous blood gas partial pressure oxygen(PO2)Other, specify (LabSpecmnOTH)____________________Blood typeBloodTypChoose one.A- A+AB-AB+B-B+O-O+RhD Factor typeRhDFactorTypChoose one.NegativePositiveType of location where the data were taken/recorded.DataAcquisitionLocationTypChoose one. If “Other, specify” is selected, please write in response.Acute Care UnitAmbulatoryAssisted LivingCentral Lab Clinic/MD OfficeCritical Access Hospital Critical Care Unit CT-AngioDischarge LoungeED arrivalED dischargeED-Non-trauma Center ED post-resuscitation ED-Trauma CenterFollow-up visitHigh Care UnitHomeHospiceICUImaging Diagnostic DepartmentInjury sceneInpatient Epilepsy Monitoring UnitInpatient RehabIntermediate Care UnitLong Term Care HospitalNursing HomeObservation UnitOROther HospitalOutpatient ClinicOutpatient EEG labPre-hospitalPre-hospital BestPre-hospital WorstReferring HospitalRehabilitation UnitSite LabStep-Down UnitSupervised LivingUnknownUrgent CareWardOther, specify (DataAcquisitionLocationOTH)____________________Comments on the laboratory test:LabTestCommentWrite comments if any:____________________________________________PREGNANCY TESTWas a pregnancy test performed?PregTestPerfIndChoose one.Yes NoNot ApplicableUnknownPregnancy test is not applicable reasonPregTestNotApplcblRsnChoose one. Response is obtained from report by participant/subject, reliable proxy or caretaker, attending medical health professional or medical records.MaleNon-surgically sterilePost-MenopausalSurgically SterileLOINC code of the laboratory testLabTestLOINCCodeCode the laboratory test that is run on the specimen using Logical Observation Identifiers Names and Codes (LOINC) - test date and timePregTestDateTime:Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times ().________________________________Specify whether the lab test date and time is accurately recorded or estimatedLabTestDateTimeRecTypChoose one. Indicate whether or not the date and time of the lab test is accurate or estimate, or unknown.AccurateEstimatedSelf-reportedUnknownSpecify the reason why of whether the lab test date and time is unknown or estimated.LabTestDateTimeUnknownRsnChoose one. Use this data element when "Lab test date and time record type" (LabTestDateTimeRecTyp) is set to "Estimate" or "Unknown".Not AvailableNot sure/Cannot rememberResponse declinedUnknownRecord the date the specimen was collected.LabSpecmnCollDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). __________________________________Pregnancy test specimen typePregTestSpecmnTypChoose one.BloodUrinePregnancy test qualitative resultPregTestQualResltVal:Choose oneNegativePositiveType of location where the data were taken/recorded.DataAcquisitionLocationTypChoose one. If “Other, specify” is selected, please write in response.Acute Care UnitAmbulatoryAssisted LivingCentral Lab Clinic/MD OfficeCritical Access Hospital Critical Care Unit CT-AngioDischarge LoungeED arrivalED dischargeED-Non-trauma Center ED post-resuscitation ED-Trauma CenterFollow-up visitHigh Care UnitHomeHospiceICUImaging Diagnostic DepartmentInjury sceneInpatient Epilepsy Monitoring UnitInpatient RehabIntermediate Care UnitLong Term Care HospitalNursing HomeObservation UnitOROther HospitalOutpatient ClinicOutpatient EEG labPre-hospitalPre-hospital BestPre-hospital WorstReferring HospitalRehabilitation UnitSite LabStep-Down UnitSupervised LivingUnknownUrgent CareWardOther, specify (DataAcquisitionLocationOTH)____________________Comments on the laboratory test:LabTestComment Write comments if any:____________________________________________HIV TESTWas the laboratory test performed?LabTestPerfIndChoose oneYesNoUnknownLOINC code of the laboratory testLabTestLOINCCodeCode the laboratory test that is run on the specimen using Logical Observation Identifiers Names and Codes (LOINC) - and time the lab test was completed/performedLabTestDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)_____________________________Specify whether the lab test date and time is accurately recorded or estimated.LabTestDateTimeRecTypChoose oneAccurateEstimatedSelf-reportedUnknownSpecify the reason why of whether the lab test date and time is unknown or estimated.LabTestDateTimeUnknownRsn. Choose one.UnknownNot AvailableNot sure/Cannot rememberResponse declinedRecord the date the lab specimen was collected.LabSpecmnCollDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)___________Lab specimen type:LabSpecmnTypSelect one. If “Other, specify” is selected, please write in response. Amniotic fluidArterial blood - buffy coat Arterial blood – plasmaArterial blood - platelets Arterial blood – serumArterial blood - whole Blood Brain tissue Bronchial lavageBuccal swab Catheter tip Cerebral spinal fluidGastric aspirateNasal Newborn cord blood PlacentaSalivaSputumStoolThroatUrineVenous blood - buffy coat Venous blood - plasma Venous blood - platelets Venous blood - serum Venous blood- wholeWound swabOther, specify ( LabSpecmnOTH)____________________What are the values of the qualitative result for a performed HIV test? HIVTestResultValChoose one.Negative PositiveInconclusiveInefficient UnknownType of location where the data were taken/recorded.DataAcquisitionLocationTypChoose one. If “Other, specify” is selected, please write in response.Acute Care UnitAmbulatoryAssisted LivingCentral Lab Clinic/MD OfficeCritical Access Hospital Critical Care Unit CT-AngioDischarge LoungeED arrivalED dischargeED-Non-trauma Center ED post-resuscitation ED-Trauma CenterFollow-up visitHigh Care UnitHomeHospiceICUImaging Diagnostic DepartmentInjury sceneInpatient Epilepsy Monitoring UnitInpatient RehabIntermediate Care UnitLong Term Care HospitalNursing HomeObservation UnitOROther HospitalOutpatient ClinicOutpatient EEG labPre-hospitalPre-hospital BestPre-hospital WorstReferring HospitalRehabilitation UnitSite LabStep-Down UnitSupervised LivingUnknownUrgent CareWardOther, specify (DataAcquisitionLocationOTH)____________________Comments on the laboratory test:LabTestCommentWrite comments if any:____________________________________________HEPATITIS TESTWas the laboratory test performed?LabTestPerfIndChoose oneYesNoUnknownLOINC code of the laboratory testLabTestLOINCCodeCode the laboratory test that is run on the specimen using Logical Observation Identifiers Names and Codes (LOINC) - and time the lab test was completed/performedLabTestDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)_____________________________Specify whether the lab test date and time is accurately recorded or estimated.LabTestDateTimeRecTypChoose oneAccurateEstimatedSelf-reportedUnknownSpecify the reason why of whether the lab test date and time is unknown or estimated.LabTestDateTimeUnknownRsn. Choose one.UnknownNot AvailableNot sure/Cannot rememberResponse declinedRecord the date the lab specimen was collected.LabSpecmnCollDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)___________Lab specimen type:LabSpecmnTypSelect one. If “Other, specify” is selected, please write in response. Amniotic fluidArterial blood - buffy coat Arterial blood – plasmaArterial blood - platelets Arterial blood – serumArterial blood - whole Blood Brain tissue Bronchial lavageBuccal swab Catheter tip Cerebral spinal fluidGastric aspirateNasal Newborn cord blood PlacentaSalivaSputumStoolThroatUrineVenous blood - buffy coat Venous blood - plasma Venous blood - platelets Venous blood - serum Venous blood- wholeWound swabOther, specify ( LabSpecmnOTH)____________________Hepatitis lab test nameHepatitisLabTestNameIndicate the name of each laboratory test that is run on the specimen. See the data dictionary for additional information on coding the test name using Logical Observation Identifiers Names and Codes (LOINC).Anti-hepatitis B core (anti-HBc), IgMAnti-hepatitis B e antibody (Anti-HBe)HAV antibody, totalHBV core antibody, totalHepatitis A antibody, IgMHepatitis B core antibody, IgMHepatitis B e-antigen (HBeAG)Hepatitis B surface AgHepatitis B surface antibody (anti-HBs)Hepatitis B surface antigen (HBsAG)Hepatitis B viral DNAHepatitis B virus resistance mutationsHepatitis C antibodyNot availableTotal anti-hepatitis B core (anti-HBc, IgM and IgG)UnknownHepatitis lab test qualitative result valueHepatitisLabTestResultValChoose one.DetectedNegativeNon detectedNon detected Or detected at very low levelNot availableNot performedPositiveUnknownType of location where the data were taken/recorded.DataAcquisitionLocationTypChoose one. If “Other, specify” is selected, please write in response.Acute Care UnitAmbulatoryAssisted LivingCentral Lab Clinic/MD OfficeCritical Access Hospital Critical Care Unit CT-AngioDischarge LoungeED arrivalED dischargeED-Non-trauma Center ED post-resuscitation ED-Trauma CenterFollow-up visitHigh Care UnitHomeHospiceICUImaging Diagnostic DepartmentInjury sceneInpatient Epilepsy Monitoring UnitInpatient RehabIntermediate Care UnitLong Term Care HospitalNursing HomeObservation UnitOROther HospitalOutpatient ClinicOutpatient EEG labPre-hospitalPre-hospital BestPre-hospital WorstReferring HospitalRehabilitation UnitSite LabStep-Down UnitSupervised LivingUnknownUrgent CareWardOther, specify (DataAcquisitionLocationOTH)____________________Comments on the laboratory test:LabTestCommentWrite comments if any:____________________________________________UTI TESTWas the laboratory test performed?LabTestPerfIndChoose oneYesNoUnknownLOINC code of the laboratory testLabTestLOINCCodeCode the laboratory test that is run on the specimen using Logical Observation Identifiers Names and Codes (LOINC) - and time the lab test was completed/performedLabTestDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)_____________________________Specify whether the lab test date and time is accurately recorded or estimated.LabTestDateTimeRecTypChoose oneAccurateEstimatedSelf-reportedUnknownSpecify the reason why of whether the lab test date and time is unknown or estimated.LabTestDateTimeUnknownRsn. Choose one.UnknownNot AvailableNot sure/Cannot rememberResponse declinedRecord the date the lab specimen was collected.LabSpecmnCollDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)___________Lab specimen type:LabSpecmnTypSelect one. If “Other, specify” is selected, please write in response. Amniotic fluidArterial blood - buffy coat Arterial blood – plasmaArterial blood - platelets Arterial blood – serumArterial blood - whole Blood Brain tissue Bronchial lavageBuccal swab Catheter tip Cerebral spinal fluidGastric aspirateNasal Newborn cord blood PlacentaSalivaSputumStoolThroatUrineVenous blood - buffy coat Venous blood - plasma Venous blood - platelets Venous blood - serum Venous blood- wholeWound swabOther, specify ( LabSpecmnOTH)____________________Length of time of UTI signs and symptomsUTISymptmDurChoose one.Less than 1 day1 to 3 days4 days to 1 week 1 to 2 weeks2 weeks to 1 month1 to 3 monthsmore than 3 monthsUrinary tract infection symptom typeUTISymptmTypChoose one. Autonomic dysreflexiaCloudy urine (with or without mucus or sediment) with increased odorDiscomfort or pain over the kidney or bladder or during micturitionFeverIncontinence, onset or increase in episodes, including leaking around catheterMalaise, lethargy or sense of uneasePyuriaSpasticity, increasedOther, specify ( UTISymptmOthrTxt)__________________________________Urinary culture species textUrCultSpecTxtEnter text to name a bacteria species in urine culture sample____________________________________________________Urinary culture statusUrCultStatusChoose oneNegativePositiveUnknownUrine dipstick test for leukocyte esteraseUrDipstckTstLeukEstrseStatusChoose one.NegativePositiveUnknownStatus of nitrite presence in urine dipstick testUrDipstckTstNitrStatusChoose one.NegativePositiveUnknownUrine culture sequence numberUrCultSeqNumEnter the sequence number.________________________________________________Urinary culture resistance pattern typeUrCultResistPattrnTypChoose one.NormalMulti drug resistantUrinary culture colony form unity measurement value, colony forming units (CFU) per mLUrCultCFUMeasrValEnter the value from 10 to 100,000________________________________________________________________Type of location where the data were taken/recorded.DataAcquisitionLocationTypChoose one. If “Other, specify” is selected, please write in response.Acute Care UnitAmbulatoryAssisted LivingCentral Lab Clinic/MD OfficeCritical Access Hospital Critical Care Unit CT-AngioDischarge LoungeED arrivalED dischargeED-Non-trauma Center ED post-resuscitation ED-Trauma CenterFollow-up visitHigh Care UnitHomeHospiceICUImaging Diagnostic DepartmentInjury sceneInpatient Epilepsy Monitoring UnitInpatient RehabIntermediate Care UnitLong Term Care HospitalNursing HomeObservation UnitOROther HospitalOutpatient ClinicOutpatient EEG labPre-hospitalPre-hospital BestPre-hospital WorstReferring HospitalRehabilitation UnitSite LabStep-Down UnitSupervised LivingUnknownUrgent CareWardOther, specify (DataAcquisitionLocationOTH)____________________Comments on the laboratory test:LabTestCommentWrite comments if any:____________________________________________BACTERIAL INFECTION TESTWas the laboratory test performed?LabTestPerfIndChoose oneYesNoUnknownLOINC code of the laboratory testLabTestLOINCCodeCode the laboratory test that is run on the specimen using Logical Observation Identifiers Names and Codes (LOINC) - and time the lab test was completed/performedLabTestDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)_____________________________Specify whether the lab test date and time is accurately recorded or estimated.LabTestDateTimeRecTypChoose oneAccurateEstimatedSelf-reportedUnknownSpecify the reason why of whether the lab test date and time is unknown or estimated.LabTestDateTimeUnknownRsn. Choose one.UnknownNot AvailableNot sure/Cannot rememberResponse declinedRecord the date the lab specimen was collected.LabSpecmnCollDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)___________Lab specimen type:LabSpecmnTypSelect one. If “Other, specify” is selected, please write in response. Amniotic fluidArterial blood - buffy coat Arterial blood – plasmaArterial blood - platelets Arterial blood – serumArterial blood - whole Blood Brain tissue Bronchial lavageBuccal swab Catheter tip Cerebral spinal fluidGastric aspirateNasal Newborn cord blood PlacentaSalivaSputumStoolThroatUrineVenous blood - buffy coat Venous blood - plasma Venous blood - platelets Venous blood - serum Venous blood- wholeWound swabOther, specify (LabSpecmnOTH)____________________The elapsed time (in minutes) from the time of injuryInjElapsedTime (*)Indicate the time since injury occurred following definition provided per protocol. ______________________________________________________________________Bacterial culture species nameBacterialCulSpecName Indicate the name of each bacterial species on which is the lab test run on the specimen.________________________________________________________________Bacterial culture species growth indicatorBacterialCulSpecGrowthIndChoose one.YesNoUnknownBacterial culture result statusBacterialCulResultStatusChoose one.NegativePositiveUnknownBacterial culture colony form unity measurement valueBacterialCulSpecCFUMeasrValEnter the value in Colony-Forming units per milliliter (cell count )_________________________________________________________________Bacterial culture sequence numberBacterialCulSpecSeqNumEnter Bacterial culture sequence numberType of location where the data were taken/recorded.DataAcquisitionLocationTypChoose one. If “Other, specify” is selected, please write in response.Acute Care UnitAmbulatoryAssisted LivingCentral Lab Clinic/MD OfficeCritical Access Hospital Critical Care Unit CT-AngioDischarge LoungeED arrivalED dischargeED-Non-trauma Center ED post-resuscitation ED-Trauma CenterFollow-up visitHigh Care UnitHomeHospiceICUImaging Diagnostic DepartmentInjury sceneInpatient Epilepsy Monitoring UnitInpatient RehabIntermediate Care UnitLong Term Care HospitalNursing HomeObservation UnitOROther HospitalOutpatient ClinicOutpatient EEG labPre-hospitalPre-hospital BestPre-hospital WorstReferring HospitalRehabilitation UnitSite LabStep-Down UnitSupervised LivingUnknownUrgent CareWardOther, specify (DataAcquisitionLocationOTH)____________________Comments on the laboratory test:LabTestCommentWrite comments if any:____________________________________________SUBSTanCE TESTWas the laboratory test performed?LabTestPerfIndChoose oneYesNoUnknownLOINC code of the laboratory testLabTestLOINCCodeCode the laboratory test that is run on the specimen using Logical Observation Identifiers Names and Codes (LOINC) - and time the lab test was completed/performedLabTestDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)_________________________________________________________________Specify whether the lab test date and time is accurately recorded or estimated.LabTestDateTimeRecTypChoose one.AccurateEstimatedSelf-reportedUnknownSpecify the reason why of whether the lab test date and time is unknown or estimated.LabTestDateTimeUnknownRsnChoose one.Not AvailableNot sure/Cannot rememberResponse declineUnknownRecord the date the lab specimen was collected.LabSpecmnCollDateTime Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)____________________________________________________________________What is the type of sample used to perform the toxic drug screen?DrgScrnSamplTypChoose all that apply.HairSalivaSerumUrineOther, specify ( DrgScrnSamplOTH)________________________________Drug screen qualitative resultDrgScrnQualResltChoose onePositiveNegativeInconclusiveNot availableType of substance(s) found positive in overall toxic drug screenDrgScrnPosSubstncTypChoose all that apply. If “Other, specify” is selected, please write in response.AmphetaminesBarbituratesBenzodiazepinesCocaine metaboliteMarijuana metabolitesMethadoneOpiates (codeine and morphine)PhencyclidinePropoxypheneOther, specify (DrgScrnPosSubstncOTH)___________________________________Whether blood alcohol test was performedAlchBldTstPerformIndChoose one:YesNoUnknownBlood alcohol content mesurement(mg/100 ml blood)AlchBldLvlMeasr_____________________________________________________Type of location where the data were taken/recorded.DataAcquisitionLocationTypChoose one. If “Other, specify” is selected, please write in response.Acute Care UnitAmbulatoryAssisted LivingCentral Lab Clinic/MD OfficeCritical Access Hospital Critical Care Unit CT-AngioDischarge LoungeED arrivalED dischargeED-Non-trauma Center ED post-resuscitation ED-Trauma CenterFollow-up visitHigh Care UnitHomeHospiceICUImaging Diagnostic DepartmentInjury sceneInpatient Epilepsy Monitoring UnitInpatient RehabIntermediate Care UnitLong Term Care HospitalNursing HomeObservation UnitOROther HospitalOutpatient ClinicOutpatient EEG labPre-hospitalPre-hospital BestPre-hospital WorstReferring HospitalRehabilitation UnitSite LabStep-Down UnitSupervised LivingUnknownUrgent CareWardOther, specify (DataAcquisitionLocationOTH)____________________Comments on the laboratory test:LabTestCommentWrite comments if any:____________________________________________LAB PANELLab panel categoryLabPanelCat Choose one. If “Other, specify” is selected, please write in response.ChemistryHematologyUrinalysisOther, specify (LabPanelOTH)____________________________________________Date and time of data collectionDataCollDateTimeRecord the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). 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.)_____________________________________________________________________Specimen accession number?SpecmnAcssnNum Provide the accession number or bar code number that is assigned to the specimen_________________________________________________________________________________APPENDIX 1: CORE TBI DATA ELEMENTSTBI core CDEs are highlighted with red asterisk (*).Variable namePage numberGUID1InjElapsedTime 36ReferencesNational Institute of Neurological Disorders and Stroke (NINDS) CDE project, Traumatic Brain Injury (TBI) CDEs (v2), Institute of Neurological Disorders and Stroke (NINDS) CDE project, Traumatic Brain Injury (TBI) CDEs (v2), Significant Medical History form (F0302_ Significant Medical History.docx) Institute of Neurological Disorders and Stroke (NINDS) CDE project, General CDEs, Medical History form (F0013Medical_History.docx) Institute of Neurological Disorders and Stroke (NINDS) CDE project, TBICDEs, Laboratory Tests form(F0320_Laboratory_Tests) E. Saatman, Ann-Christine Duhaime, Ross Bullock, Andrew I.R. Maas, Alex Valadka, and Geoffrey T. Manley. Journal of Neurotrauma. November 2010, 25(7): 719-738. doi:10.1089/neu.2008.0586.Maas, Stocchetti, Bullock , Moderate and severe traumatic brain injury in adults, A review, The LANCET Neurology, Volume 7, Issue 8, August 2008, Pages 728–741, (08)70164-9Cantor J, Ashman T, Dams-O’Connor K, et al. Evaluation of the short-term executive plus intervention for executive dysfunction after traumatic brain injury: a randomized controlled trial with minimization. Arch Phys Med Rehabil. 2014;95(1):1-9.e3.Maas et al, Standardizing Data Collection in Traumatic Brain Injury, J Neurotrauma. 2011 Feb; 28(2): 177–187. doi: 10.1089/neu.2010.1617Hawryluk GW, Manley GT. Classification of traumatic brain injury: past, present, and future. Handb Clin Neurol. 2015;127:15-21. Lingsma HF, Yue JK, Maas AI, Steyerberg EW, Manley GT; TRACK-TBI Investigators, Cooper SR, Dams-O'Connor K, Gordon WA, Menon DK, Mukherjee P, Okonkwo DO, Puccio AM, Schnyer DM, Valadka AB, Vassar MJ, Yuh EL. Outcome prediction after mild and complicated mild traumatic brain injury: external validation of existing models and identification of new predictors using the TRACK-TBI pilot study. J Neurotrauma. 2015 Jan 15;32(2):83-94. Pellman, Elliot J. M.D.; Powell, John W. Ph.D.; Viano, David C. Dr. med., Ph.D.; Casson, Ira R. M.D.; Tucker, Andrew M. M.D.; Feuer, Henry M.D.; Lovell, Mark Ph.D.; Waeckerle, Joseph F. M.D.; Robertson, Douglas W. M.D. Concussion in Professional Football: Epidemiological Features of Game Injuries and Review of the LiteraturePart 3. Neurosurgery: January 2004 - Volume 54 - Issue 1 - pp 81-96, doi: 10.1227/01.NEU.0000097267.54786.54CDISC Traumatic Brain Injury Therapeutic Area Data Standard User Guide v1 (Provisional) lab test . Harabangui et. Al. Experiments with Open-Domain Textual Question Answering, in proceedings of COLING-2000, Saarburkrn, Germany, pp 292-298, August 2000 ................
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