This is a try at UML diagrams for type diabetes. Use case: These are text descriptions of a subject s experience when they enter the healthcare setting and their data is used for secondary research. Description: A healthcare provider who is affiliated with a Type Diabetes (TD) clinical research study observes the patient in the facility. The healthcare provider conducts a routine patient visit to monitor and record clinical progress, relative to TD management, in the Electronic Health Record (EHR). The data is then used to populate the Case Report Forms for the clinical research study in which the patient is already enrolled. The healthcare provider may be a physician, a nurse practitioner (NP), a physician s assistant (PA), or a research coordinator. In the use case the term clinician is used throughout. The clinician has 2 roles: healthcare provider and researcher. Actors: Patient (in patient role) Patient (in subject role) Clinician (in clinical provider role) Clinician (in research investigator role) Sponsor of the research study Goal: Develop clinical content data standards for type diabetes which support patient care and secondary data uses Trigger: Scheduled protocol visit in the clinic Pre-conditions:. A TD module exists in the EHR. This module collects complete and standardized data for the management of TD. 2. Specific elements on the TD EHR module are designated as required elements for a particular research protocol. 3. A patient record is clearly marked that the patient is enrolled in the research study of interest. Normal Path:. Patient (in subject role) arrives to clinic for a scheduled protocol visit. 2. The physician (in research investigator role) observes patient and orders required tests per research protocol. 3. Physician (in research investigator role) opens EHR to a specific TD module. 4. Physician (in research investigator role) records study data as required per protocol. 5. Physician (in clinical provider role) notes any other observations in the EHR TD module as desired as part of the clinical visit. 6. Physician (in research investigator role) selects submit research data button that is on the TD module. 7. The completed research data elements from the TD model of the EHR (already flagged as research data elements) are copied to a separate research database, held by the study sponsor. The data remain in the EHR.
8. Physician signs out of EHR/patient visit as they normally would in a clinical visit. Alternative Path: The research use of the data might occur after the health visit. The clinician will conduct a routine patient visit to monitor and record clinical progress relative to TD management in the EHR. Exceptions: The subject withdraws his/her consent from the study or dropped by the PI from the study for any reason. The clinician continues collecting data in EHR, but stops sending data to the research database. Priority: High for all users
TD Class Diagram: Diagnosis and Treatment TypeDiabetesSymptoms/ClinicalFindings + polydipsia: boolean + polyuria: boolean + polyphasia: boolean + UnexplainedWeightLoss: boolean + diabeticketoacidosis: boolean + fatigue: boolean TypeDiabetesDiagnosis + typediabetesdiagnosisdate: date + ckinicalfindings: char FamilyHistory + bloodrelativewithtd: char + bloodrelativewithautoimmunedisease: char Insulin Type + regular: char + intermediateacting: char + longacting: char GlycemiCcontrolMethod + selfmonitored: boolean + bloodtest: boolean + urinetest: boolean Commom::Patient 0 * Commom::ClinicRegistration Commom::PatietEncounter 0 * * Commom::Clinician Test + effectivedatetime: int + testdonecode: char + typecode: char BloodGlucose + casualplasmaglucose: int + fasting PlasmaGlucose: int + oralglucosetolerancetest: int + HbAc: int AutoimmuneAntibody Test + HLATyping: char + AutoimmuneThyroidDisease: char + GlutamicAcidDecarboxylaseAntibodies: char + C-peptide: int ancillarytests + ThyroidPanel: int + LipidPanel: int + BasicMetabolicPanel: int UrineTest + glucose: char + ketones char + microalbumin: char PhysicalExam + eyeexam: char + footexam: char + dentalexam: char
Table. Multiplicity Indicators. (source: http://www.agilemodeling.com/artifacts/classdiagram.htm#classes Indicator Meaning 0.. Zero or one One only Zero or more..* One or more n Only n (where n > ) 0..n Zero to n (where n > )..n One to n (where n > )