Medical History - NINDS Common Data Elements
Date Medical History Taken (MM/DD/YYYY):For women:**Is the participant/subject pregnant? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIF YES, specify current state: FORMCHECKBOX Pre-partum 1st trimester FORMCHECKBOX Pre-partum 2nd trimester FORMCHECKBOX Pre-partum 3rd trimester FORMCHECKBOX Active labor**Is the participant/subject post-partum (up to 12 weeks)? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIF YES, specify current state: FORMCHECKBOX Postpartum first 24 hrs FORMCHECKBOX Postpartum first week FORMCHECKBOX Postpartum > 1 weekNumber of weeks since delivery:**Does the participant/subject have a history of any medical problems/conditions in the following body systems? FORMCHECKBOX Yes FORMCHECKBOX No (leave rest of form blank) 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.*Use BODY SYSTEM categories for medical history table:Constitutional symptoms (e.g., fever, weight loss)EyesEars, Nose, Mouth, ThroatCardiovascular RespiratoryGastrointestinalGenitourinaryMusculoskeletalIntegumentary (skin and/or breast)NeurologicalPsychiatricEndocrineHematologic/LymphaticAllergic/ImmunologicTable of subject’s/participant’s medical history itemsBody SystemMedical History Term (one item per line)Start Date (mm/dd/yyyy)Ongoing?End Date (mm/dd/yyyy)Data to be entered by siteData to be entered by siteData to be entered by site FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteData to be entered by siteData to be entered by siteData to be entered by site FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteData to be entered by siteData to be entered by siteData to be entered by site FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteData to be entered by siteData to be entered by siteData to be entered by site FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteData to be entered by siteData to be entered by siteData to be entered by site FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteData to be entered by siteData to be entered by siteData to be entered by site FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteData to be entered by siteData to be entered by siteData to be entered by site FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteData to be entered by siteData to be entered by siteData to be entered by site FORMCHECKBOX Yes FORMCHECKBOX NoData to be entered by siteThe following interview questions can be used to help make sure a complete medical history is documented.Has a doctor or other medical professional ever told you that you have or have had the following?**Any stroke: FORMCHECKBOX Yes FORMCHECKBOX No (Skip to 2) FORMCHECKBOX Unknown (Skip to 2)**Ischemic stroke: FORMCHECKBOX Yes FORMCHECKBOX No (Skip to 1B) FORMCHECKBOX Unknown (Skip to 1B)Number of ischemic strokes: FORMCHECKBOX 1 FORMCHECKBOX ≥ 2 FORMCHECKBOX Unknown Most recent ischemic stroke: FORMCHECKBOX < 3 mos ago FORMCHECKBOX ≥ 3 mos ago FORMCHECKBOX Unknown (mos = months)**Hemorrhagic stroke: FORMCHECKBOX Yes FORMCHECKBOX No (Skip to 2) FORMCHECKBOX Unknown (Skip to 2)If YES, indicate type(s): FORMCHECKBOX Intracerebral hemorrhage (ICH) FORMCHECKBOX Subarachnoid hemorrhage (SAH) FORMCHECKBOX Hemorrhage unspecified FORMCHECKBOX Unknown***Number of hemorrhagic strokes: FORMCHECKBOX 1 FORMCHECKBOX ≥ 2 FORMCHECKBOX Unknown Most recent hemorrhagic stroke: FORMCHECKBOX < 3 mos ago FORMCHECKBOX ≥ 3 mos ago FORMCHECKBOX Unknown (mos = months)Transient ischemic attack (TIA): FORMCHECKBOX Yes FORMCHECKBOX No (Skip to 5) FORMCHECKBOX Unknown (Skip to 5)Number of TIAs: FORMCHECKBOX 1 FORMCHECKBOX 2-10 FORMCHECKBOX >10 FORMCHECKBOX UnknownMost recent TIA: FORMCHECKBOX < 24 hrs ago FORMCHECKBOX 24hrs-7days ago FORMCHECKBOX 7days-3mos ago FORMCHECKBOX > 3mos ago FORMCHECKBOX UnknownTransient monocular blindness: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownUnruptured aneurysm: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownDural sinus thrombosis/cerebral venous thrombosis: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownArteriovenous malformation (AVM): FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCavernous malformation: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownMigraine(s): FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, migraine(s) with aura: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown***If YES, active migraine within last year? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCarotid stenosis: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCarotid endarterectomy: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, indicate location: FORMCHECKBOX Left side FORMCHECKBOX Right side FORMCHECKBOX Both FORMCHECKBOX Unknown***Date of most recent carotid endarterectomy (MM/DD/YYYY):Carotid artery stenting: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, indicate location: FORMCHECKBOX Left side FORMCHECKBOX Right side FORMCHECKBOX Both FORMCHECKBOX Unknown***Date of most recent carotid artery stenting (MM/DD/YYYY):Has a doctor or other medical professional ever told you that you have or have had the following?Seizure episode: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownEpilepsy/ Seizure disorder: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCentral nervous system infection: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownMeningitis: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownDementia: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCurrent clinical depression: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownDepressive disorder diagnosis: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown***If YES, age experienced first depressive episode/ diagnosed with depression (years):Current clinical anxiety: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownAnxiety/panic disorder diagnosis: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownPsychotic disorder: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, indicate type(s): (choose all that apply) FORMCHECKBOX Schizophrenia FORMCHECKBOX Depression w/ psychotic features FORMCHECKBOX Bipolar disorder FORMCHECKBOX Dementia with psychotic ideation FORMCHECKBOX Psychotic disorder, not otherwise specified FORMCHECKBOX Other, specify: FORMCHECKBOX UnknownHead trauma: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, indicate if head trauma resulted in any of the following (choose all that apply): FORMCHECKBOX Loss of consciousness > 30 minutes FORMCHECKBOX Post traumatic amnesia > 24 hours FORMCHECKBOX Abnormal brain imaging findings FORMCHECKBOX None of the above FORMCHECKBOX UnknownNeck trauma: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown If YES, indicate recency: FORMCHECKBOX < 8 days before current stroke/TIA FORMCHECKBOX 8 days- 4 weeks ago FORMCHECKBOX > 4 weeks ago FORMCHECKBOX UnknownAtrial fibrillation (AF)/ flutter: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownRheumatic heart disease: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown***Other cause of AF: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown***If YES, specify other cause:Coronary artery disease: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownHas a doctor or other medical professional ever told you that you have or have had the following?Myocardial infarction: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownAngina: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownValvular heart disease: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCardiac surgery: FORMCHECKBOX Yes FORMCHECKBOX No (Skip to 32) FORMCHECKBOX Unknown (Skip to 32)***Indicate type(s): FORMCHECKBOX Coronary artery bypass graft (CABG) FORMCHECKBOX Cardiac valve surgery, including non-open surgery (i.e., percutaneous valvuloplasty) FORMCHECKBOX Pacemaker FORMCHECKBOX Implantable cardiac defibrillator FORMCHECKBOX Other, specify:***Date of most recent cardiac surgery (MM/DD/YYYY):Artificial valve: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown***If YES, indicate type: FORMCHECKBOX Biological/ Tissue valve FORMCHECKBOX Mechanical/ Non-tissue valve FORMCHECKBOX Valvuloplast FORMCHECKBOX Unknown type of valveCoronary stent or PTCA: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCongestive heart failure: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCongenital heart disease: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCardiac catheterization: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown***If YES, indicate recency: FORMCHECKBOX ≤ 2 weeks FORMCHECKBOX > 2 weeks ago FORMCHECKBOX 30 days or more FORMCHECKBOX UnknownOther cardiac disorders, specify:Peripheral arterial disease: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownAortic aneurysm: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, specify type:Hypertension: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, age hypertension first diagnosed (years):Treatment for hypertension (choose all that apply): FORMCHECKBOX Lifestyle modification only FORMCHECKBOX Oral medication FORMCHECKBOX None FORMCHECKBOX UnknownOrthostatic hypotension: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownDiabetes mellitus: FORMCHECKBOX Yes FORMCHECKBOX No (Skip to 42) FORMCHECKBOX Unknown (Skip to 42)Age diabetes first diagnosed (years):Complications of diabetes (choose all that apply): FORMCHECKBOX Nephropathy FORMCHECKBOX Neuropathy FORMCHECKBOX Retinopathy FORMCHECKBOX Other, specify: FORMCHECKBOX None of the aboveTreatment for diabetes (choose all the apply): FORMCHECKBOX Diet FORMCHECKBOX Oral medication FORMCHECKBOX Insulin FORMCHECKBOX None of the above FORMCHECKBOX UnknownHas a doctor or other medical professional ever told you that you have or have had the following?High blood cholesterol / Hypercholesterolemia: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, indicate treatment(s): (choose all the apply) FORMCHECKBOX Diet FORMCHECKBOX Statins FORMCHECKBOX Other medicines FORMCHECKBOX None of the above FORMCHECKBOX UnknownHypertriglyceridemia: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown Cancer: FORMCHECKBOX Yes FORMCHECKBOX No (Skip to 45) FORMCHECKBOX Unknown (Skip to 45)***Type(s) of cancer: FORMCHECKBOX Brain FORMCHECKBOX Breast FORMCHECKBOX Colorectal FORMCHECKBOX Endometrial FORMCHECKBOX Esophagus FORMCHECKBOX Lung FORMCHECKBOX Prostate FORMCHECKBOX Renal (kidney) FORMCHECKBOX Skin FORMCHECKBOX Other, specify:***Did you receive head or neck radiation to treat the cancer? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown***Infection within two weeks: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, indicate type(s) (choose all that apply): FORMCHECKBOX Respiratory infection FORMCHECKBOX Urinary tract infection (UTI) FORMCHECKBOX Cellulitis FORMCHECKBOX Sepsis FORMCHECKBOX Otitis media FORMCHECKBOX Mastoiditis FORMCHECKBOX Viral gastroenteritis FORMCHECKBOX Fever lasting > 48 hours FORMCHECKBOX Influenza FORMCHECKBOX Zoster/Shingles FORMCHECKBOX Other infection, specify:***Periodontal disease: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownSickle cell anemia: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, are blood transfusions used as treatment? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownHypercoagulable disorder: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, specify type:Bleeding disorder: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, specify type:Lupus: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownOther connective tissue disease: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, specify type: Sleep apnea: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf YES, specify type:Has a doctor or other medical professional ever told you that you have or have had the following?Renal (kidney) failure: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownNephrotic syndrome: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIndwelling catheter: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownChronic liver failure: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIron deficiency/ Anemia: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownInflammatory bowel disease: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownHemorrhoids: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownMoyamoya Syndrome: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownDown syndrome: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownNeurofibromatosis type I (NF1): FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownSturge-Weber syndrome: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown Inborn error metabolism: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown Mitochondrial disease: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown ***If YES, do you have/ have you had mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS)? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownHereditary hemorrhagic telangiectasia: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownEhlers-Danlos Syndrome Type IV: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownMarfan syndrome: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownFibromuscular dysplasia: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownCoarctation of the aorta: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownAlpha1-antitrypsin deficiency: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownPheochromocytoma: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownOther, specify:***Are you in menopause? FORMCHECKBOX Yes FORMCHECKBOX No***At what age did you start menopause (if applicable)?***Treatment for menopause: FORMCHECKBOX Hormone therapy FORMCHECKBOX Other, specify: FORMCHECKBOX UnknownAdditional Pediatric-specific ElementsThese elements are recommended for pediatric stroke studies.Acquired heart disease: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown***Chickenpox in past 12 months: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Unknown***Facial Segmental Hemangioma/PHACE syndrome: FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownGeneral InstructionsMedical history data are collected to help verify the inclusion and exclusion criteria (e.g., no history of cognitive disabilities), ensure the participant/ subject receives the appropriate care and describe the study population. Typically, the Medical History CRF captures conditions that EVER occurred at some point in time within a protocol-defined period (e.g. the last 12 months). Some of the data elements included on this CRF Module are considered Core, Supplemental – Highly Recommended or Exploratory, as indicated by asterisks below:* Element is classified as Core**Element is classified as Supplemental – Highly Recommended***Element is classified as ExploratoryThe remaining data elements are Supplemental and should only be collected if the research team considers them appropriate for their study.Specific InstructionsPlease see the Data Dictionary for definitions for each of the data elements included in this CRF Module.Date Medical History Taken -- Record the date (and time) the medical history was taken. 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.Pregnancy current state – Answer only if female participant/subject is pregnant.In postpartum period current state – Answer only if female participant/subject is in postpartum state.Does this participant/subject have…? – Choose one. If this question is answered NO then the rest of the form is blank. If the question is answered YES then the medical history for at least one body system should be recorded.Body System – Record the appropriate body system for each line of medical history.Condition/Disease - Record one Medical History term per line. See the data dictionary for additional information on coding the condition using SNOMED CT.Start Date –Record the date the medical condition/disease started. 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.Ongoing? – Check Yes or No to indicate if the medical condition/disease is still present.End Date – If the condition is not ongoing, record the date (and time) the medical condition/disease stopped. 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.ReferencesKamel H, Navi BB, Sriram N, Hovsepian DA, Devereux RB, Elkind MSV. Risk of a thrombotic event after the 6-week postpartum period. New Engl J Med. 2014;370(14):1307-1315. ................
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