:Clinical_Encounter a owl:Class ; :created "2012-5-31"^^xsd:date ; :lastModified "2012-6-28"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "The patient’s encounters with differing clinicians and the general setting information associated with those encounters" . :DSM_Diagnosis a owl:Class ; :created "2012-5-1"^^xsd:date ; :lastModified "2012-7-20"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "The patient’s diagnosis with respect to Axis I, II, and III of the DSM Diagnostic formulation." . # Name Type Notes Age_At_Diagnosis :derived caDSR definition: "Age at diagnosis may be derived or asked directly of the patient or patient proxy." May be obtained from clinical documentation or asked directly of patients. # page 3 Diagnosis_Date xsd:date Date when the DSM-IV-TR based diagnosis was made, e.g., a trial visit date. Not necessarily the diagnosis onset date. DSM-IV_Diagnosis dt:CD DSM-IV-TR diagnosis code on Axes where applicable. DSM-IV_Diagnosis_Axis dt:CD Axis of the DSM-IV-TR diagnosis. DSM_AxisI_Specifiers xsd:string Axis I diagnosis specifiers from DSM diagnostic criteria. Onset_Diagnosis_Date xsd:date Date of earliest diagnosis for the DSM-IV-TR diagnosis, i.e., the date when the disorder started. :Drug_Monitoring a owl:Class ; :created "2012-5-31"^^xsd:date ; :lastModified "2012-7-20"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "Ongoing efforts to assess a patient's drug taking behavior occurring during a discrete office encounter, that could relate both to treatment compliance and substance abuse." . # Name Type Notes Date/Time_Monitored_Drug_Dose_Prior_To_Specimen_Collection :date_or_null_flavor The date and time of the dose of study medication prior and closest to the pharmacokinetic sample collection. Date/Time_Of_Next_To_Last_Dose_Of_Monitored_Drug_Prior_To_Sampling :date_or_null_flavor The date and time of the dose of study medication before the dose prior to the pharmacokinetic sample collection. Date_Of_Last_Medication_Change :date Date of last clinically significant medication change. May be asked directly of patients or their proxy or may be obtained directly from clinical documentation. Pharmacokinetic_Blood_Draw_Date/Time :date_or_null_flavor Date and time of actual pharmacokinetic blood draw (or null flavor). Pharmacokinetic_Sample_Collected_Indicator dt:CD caDSR definition: "Text term to signify the collection of a pharmacokinetic biospecimen." Study_Drug_Level xsd:decimal Measured serum plasma level of medication. :Episodes a owl:Class ; :created "2012-5-31"^^xsd:date ; :lastModified "2012-7-5"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "A discrete period of time demarcated by when a clinician first diagnoses a disorder, and ending when acute symptoms of that disorder are judged by a clinician as no longer manifest in sufficient quality or severity to qualify for that diagnosis." . # Name Type Notes Daily_Living_Situation dt:CD Categorization of the patient's living arrangements for the majority of the time in the past 12 months. May be asked directly of patients or their proxy or may be obtained directly from clinical documentation. Date_Of_Hospitalization_For_Current_Schizophrenic_Episode :date Date of inpatient admission for the current schizophrenic episode. Duration_of_Current_Relapse xsd:decimal Number of days between onset of the current relapse and the evaluation. # page 4 Duration_Of_Treatment_for_Current_Episode :numeric_or_derived Duration in days of treatment for the current psychotic episode as of the evaluation date. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Episode_Severity_Comparison dt:CD Clinician assessment of symptom severity compared with the previous episode. Episode_Symptom_Similarity_To_Previous_Episodes_Classification dt:CD Clinician assessment of whether or not the current symptoms differ in character to those from the previous episode. Existence_Of_Precipitating_External_Stress dt:CD Presence of precipitating external stressors. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. First_Definitive_Symptom_Date xsd:date The date of first definitive symptoms of the disease or disorder obtained from clinical observation, family and friends of the patient or directly from the patient. The earliest diagnosis date is sometimes used as an operationalization of or surrogate for the start of a disease or disorder. First_Schizophrenic_Episode_Indicator dt:CD Indication that the documented episode is the patient's first schizophrenic episode. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Involuntary_Committed_Patient_Indicator dt:CD Yes, no indication whether or not the hospitalization was an involuntary commitment. # @@ s/dt:CD/xsd:boolean/? Length_of_Current_Hospitalization :numeric_or_derived Duration of hospitalization as of the evaluation; calculated from data element 37(Date of Hospitalization for Current Schizophrenic Episode). Speed_Of_Episode_Onset :CD_or_null_flavor Timing of onset of schizophrenic episode. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. :Mental_Health_History a owl:Class ; :created "2012-5-31"^^xsd:date ; :lastModified "2012-7-5"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "A general description of the patient’s past Mental Health Diagnoses and Treatments" . :Patient a owl:Class ; :created "2012-5-31"^^xsd:date ; :lastModified "2012-7-20"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "The person who is being assessed, diagnosed, and/or treated for Schizophrenia Spectrum Disorder (e.g., Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder)." . # Name Type Notes Date_Of_Birth xsd:date Patient's date of birth History_of_Tardive_Dyskinesia_Indicator dt:CD Yes, no indication that a patient has ever experienced Tardive dyskinesia. May be asked directly of patients or their proxy or may be obtained directly from clinical documentation. Lifetime_Number_Of_Arrests xsd:decimal Number of times the patient has been arrested. May be asked directly of the patent or their proxy or be obtained from clinical documents. # page 5 :Schizophrenia_Diagnosis a owl:Class ; :created "2012-5-1"^^xsd:date ; :lastModified "2012-7-20"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "A description of the patient’s diagnosis for Schizophrenia." . # Name Type Notes Diagnosis_Clinical_Relevance_Indicator dt:CD Yes, no indication of whether the diagnosis is clinically relevant to the situation under consideration. Longitudinal_Course_Of_Schizophrenia dt:CD SCID-based categorization of the character of a patient's symptoms over time. Schizophrenia_Diagnosis_By_SCID_Indicator dt:CD Yes, no indication whether the diagnosis was made or confirmed using the "Structured Clinical Interview for DSM Disoders" (SCID) CV or RV. Can be asked directly or derived from presence of data element 8 (SCID performed date) Schizophrenia_Diagnosis_Indicator :CD_or_derived Yes, no indication derived from presence of a DSM-IV-TR based Schizophrenia diagnosis including Paranoid (295.30), Disorganized (295.10), Catatonic (295.20), Undifferentiated (295.90), Residual (295.60) Schizophrenia_Primary_Diagnosis_Indicator dt:CD Yes, no indication whether or not Schizophrenia is the primary DSM-IV-TR diagnosis. :Treatment a owl:Class ; :created "2012-5-10"^^xsd:date ; :lastModified "2012-7-20"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "Information describing the surrounding details of a patient’s treatment for Schizophrenia" . # Name Type Notes Continuation_Of_Previous_Episode_Indicator dt:CD Yes, no indicator of whether the episode is a new episode (new definitive symptoms) or whether the condition is ongoing (Improvement or stabilization followed by worsening of symptoms) from the previous assessment. # ################## :Clinical_Encounter a owl:Class, :Package ; :created "2012-6-19"^^xsd:date ; :lastModified "2012-6-19"^^xsd:date ; # Clinical Encounter # Created By: Nathaniel on "2012-6-19"^^xsd:date Last Modified: "2012-7-20"^^xsd:date, Version:1.0 # # page 6 # Figure: 2 :24_Month_In_Patient_Hospitalization_History a owl:Class ; :created "2012-5-31"^^xsd:date ; :lastModified "2012-7-20"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "Setting specific information about the history of a patient's in-hospitalization stays over the past 24 months." . # Name Type Notes Day_Or_Night_Clinic_Stays_Past_24_Months_Indicator dt:CD Yes, no indication of day or night clinic use in the past 24 months. This information may be asked directly of the patient or their proxy or obtained from clinical documentation. Hospitalization_End_Date dt:CD Date of discharge from inpatient hospital. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Hospitalization_Start_Date :date_or_null_flavor Date of hospital admission. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Involuntary_Commitment_Indicator dt:CD Yes, no indication whether or not the hospitalization was an involuntary commitment. Number_Of_Schizophrenic_Hospitalizations_Past_24_Months dt:decimal Number of Psychiatric hospitalizations in the preceeding 24 months excluding crrent hospitalization if the patient is currently hospitalized. This may be asked directly of the patient or their proxy or obtained from clinical documentation. # page 7 :Clinical_Encounter a owl:Class ; :created "2012-5-31"^^xsd:date ; :lastModified "2012-6-28"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "A patient’s encounter with a licensed health care provider and the general setting information associated with that encounter." . :Drug_Saftey_Monitoring a owl:Class ; :created "2012-5-31"^^xsd:date ; :lastModified "2012-7-1"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "" . # Name Type Notes Body_Mass_Index dt:decimal Calculation of the patient's body mass index (BMI) Height numeric Patient's height Injection_Site_Evaluation_Indicator :CD_or_null_flavor @@@ Prolactin_Level :numeric_or_null_flavor Measured level of serum prolactin. Weight xsd:decimal Patient's weight :Rating_Scale_Administration a owl:Class ; :created "2012-6-14"^^xsd:date ; :lastModified "2012-6-21"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "" . # Name Type Notes CGI_Rater_Different_From_Last_Assessment dt:CD Yes, no indication that the rater for the associated assessment is different from the rater for the previous assessment. This data element is derived by comparing the rater identifier for the two assessments. Clinical_Global_Impression_Global_Improvement_Scale :CD_or_null_flavor Clinician's assessment of the total improvement since initiation of the current Treatment whether or not, in the clinician's judgment, it is due entirely to Drug treatment (or null flavor). Clinical_Global_Impression_Severity_Of_Illness :CD_or_null_flavor Clinician's assessment of the severity of the subject's psychotic disorder at the time of the assessment (or null flavor). Date_of_CGI_Assessment :date_or_null_flavor Date on which CGI was assessed. Rater_Unique_Identifier xsd:string Text such as name, initials or an assigned unique number that allows identification of the person administering the questionairre, test, or assessment for operational purposes. # page 8 :Study_Participation a owl:Class ; :created "2012-7-20"^^xsd:date ; :lastModified "2012-7-20"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "Describes a patient's involvement in Clinical studies." . # Name Type Notes Adverse_Event_Other_Primary_Reason_Specify xsd:string Verbatim clinician assessment of the reason for study termination used when none of the valid values for Data Element 76 (Reason for study discontinuation) apply. Reason_For_Study_Discontinuation xsd:string The primary reason that a subject's participation in a clinical study ended; including successful completion of the study. Schizophrenic_Treatment_Setting_Prior_To_Study_Entry dt:CD Setting in which the patient is currently being treated, or was treated just prior to evaluation. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Study_Termination_AE_Link xsd:string Referential link to the data record storing the detail of the adverse event prompting study termination Study_Termination_PV_Link xsd:string Referential link to the data record storing the detail of the protocol violation prompting study termination # ################## :Mental_Health_History a owl:Class, :Package ; :created "2012-6-19"^^xsd:date ; :lastModified "2012-6-19"^^xsd:date ; #Mental Health History #Created By: Nathaniel on "2012-6-19"^^xsd:date Last Modified: "2012-7-20"^^xsd:date, Version:1.0 ## page 9 #Figure: 3 :Family_History a owl:Class ; :created "2012-5-10"^^xsd:date ; :lastModified "2012-7-20"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "A description and indicator of any immediate relatives that have had schizophrenia to some varying degree." . # Name Type Notes Blood_Relative_Axis-I_Diagno sis CD DSM-IV-TR diagnosis text label reported by patient for a blood relative. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Family_History_Of_Schizophre nia_Indicator :CD_or_null_flavor, derived Yes, no indication of whether or not the patient has a family history of Schizophrenia. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Relative_Code CD First or second degree blood relative reported by patient to have Axis I diagnosis, i.e., mother, father, brother, sister, child, Aunt, Uncle, or Grandparent. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. :Mental_Health_History a owl:Class ; :created "2012-5-31"^^xsd:date ; :lastModified "2012-7-5"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "Model Specification Page: 10" . Notes: A general description of the patient’s past Mental Health Diagnoses and Treatments :Psychiatric_Events a owl:Class ; :created "2012-5-10"^^xsd:date ; :lastModified "2012-7-5"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "A description and indicator of any of a patient's past Psychiatric diagnoses, or of events attributable to mental health causes that created substantial and acute functional impairment." . # Name Type Notes Age_At_First_Treatment_For_ Psychiatric_Illness :numeric_or_derived Age at first treatment for any psychiatric illness. May be calculated from birthdate and date of earliest psychiatric treatment or asked directly of the patient. Ever_Admitted_To_Psychiatric _Hospital_Or_Unit_Indicator CD Yes/no indication of whether or not the patient has ever been admitted to an inpatient psychiatric hospital or unit. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Lifetime_Number_Of_Previous _Psychiatric_Hospitalizations numeric Number of inpatient psychiatric hospitalizations in the patient's lifetime excluding study required confinements and present hospitalization if currently hospitalized. This information may be asked directly of patients or obtained from clinical documentation. Reason_For_Hospitalization text Primary reason for an inpatient psychiatric hospitalization. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Reason_For_Psychiatric_Hospi talization_Category CD Clinician's evaluation of patient complaint. :Psychotic_Events a owl:Class ; :created "2012-5-10"^^xsd:date ; :lastModified "2012-7-5"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "A description and indicator of any of a patient's past Psychotic diagnoses, or of incidents in which delusions or hallucinations created substantial and acute functional impairment." . # Name Type Notes Date_Of_Last_Psychotic_Relap se Date Start date of the patient's most recent psychotic relapse excluding the current relapse if the patient is currently in a psychotic episode. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Date_Of_Last_Psychotic_Symp tom Date Date of the patient's last psychotic symptom following discharge from an inpatent facility. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Duration_Of_Most_Recent_Rel apse numeric Duration in days of the patient's most recent psychotic relapse. This may be asked directly of patients or their proxies. Response_To_Previous_Antips CD Overall assessment of the patient's response to prior # page 11 ychotics antipsychotic therapy (or null flavor). :Schizophrenia_Events a owl:Class ; :created "2012-5-10"^^xsd:date ; :lastModified "2012-6-21"^^xsd:date ; rdfs:isDefinedBy ""^^xsd:anyURI ; rdfs:comment "A description and indicator of any past Schizophrenic events and diagnoses in the patient’s history." . # Name Type Notes Age_At_First_Hospitalization_ For_Schizophrenia :numeric_or_derived Age at first hospitalization for Schizophrenia. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Age_At_First_Schizophrenia_ Episode :numeric_or_derived Age at first Schizophrenia episode. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Duration_Of_Current_Relapse numeric Number of days between onset of the current relapse and the evaluation Ever_Hospitalized_For_Schizo phrenia derived/CD Yes, no indication of whether or not the patient was ever hospitalized for Schizophrenia. May be asked directly of patients or their proxies, obtained directly from clinical documentation, or may be derived from answer to data element 36 (Lifetime_Number_Of_Schizophrenic_Hospitalization s). Lifetime_Number_Of_Prior_Sc hizophrenic_Episodes numeric Number of schizophrenia episode, i.e., period of heightened symptoms, in the patient's entire lifetime excluding current episode if patient is in a schizophrenic episode. Episodes may or may not correspond to hospitalizations. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Lifetime_Number_Of_Schizop hrenic_Hospitalizations :numeric_or_null_flavor Count of the total number of times the patient has been admitted to an inpatient facility for a schizophrenic episode. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Onset_Date_Of_Most_Recent_ Schizophrenic_Episode date Start date of most recent Schizophrenia episode, exclusing current episode. May be asked directly of patients or their proxies or be obtained directly from clinical documentation. Past_24_Months_Number_Schi zophrenic_Episodes :numeric_or_derived Number of schizophrenia episodes in the 24 moths preceding the assessment. Can be asked directly or calculated from onset and end dates of Schizophrenia episodes if a comprehensive lists is collected.