Patient Data

From CaisisWiki

Contents 1 The Patient Data Tab – Data Entry Overview 1.1 Entering Data – the Data Entry Controls 1.1.1 New 1.1.2 Edit 1.1.3 Save 1.1.4 Cancel 1.1.5 Delete 1.1.6 Lock 1.1.6.1 Unlocking 1.2 Entering Data – the Audit Log 1.3 Navigating the Patient Data Screen 1.4 The Patient Summary Screen 1.5 Navigational Menus 1.6 The Date Variable Value (DVV) lists described 1.6.1 Most Relevant 1.6.2 List All 1.6.3 Actions 1.6.4 Allergies 1.6.5 Biopsies 1.6.6 Brachytherapy 1.6.7 Categories 1.6.8 Clinical Stages 1.6.9 Comorbidities 1.6.10 Consent 1.6.11 Cytologies 1.6.12 Diagnostics 1.6.13 Dietary Intake 1.6.14 Encounters 1.6.15 Endoscopies 1.6.16 Family History 1.6.17 Identifiers 1.6.18 Lab Tests 1.6.19 Medications 1.6.20 Medical Tx 1.6.21 Physicians 1.6.22 Procedures 1.6.23 Prostatectomy 1.6.24 Protocols 1.6.25 QOL Therapy 1.6.26 Radiation Tx 1.6.27 Social History 1.6.28 Status 1.6.29 Surgeries 1.6.30 Surveys 1.6.31 Toxicities 1.6.32 All Treatments 1.6.33 Missing Items 1.6.34 Pending Items

The Patient Data Tab – Data Entry Overview

The Patient Data tab serves as an interface for data entry and display. Once a patient is selected, the Patient Data section will display. There are two main parts of this section: the Date, Variable, Value (DVV) list and the entry forms. The DVV list can be seen on the left side of the screen; it is a running list of all items in the database sorted in chronological order. On the right side are the data entry forms for all of the data that can be stored in Caisis including medications, surgeries, medical therapies, and more. As you click through the DVV list, the forms screen on the right will refresh to show you the details associated with that specific record.

Entering Data – the Data Entry Controls

The Data Entry Controls

All of the entry screens in the Patient Data section have a consistent set of data entry controls. These buttons are used to modify, delete, and add new records. A summary of each button can be found below.

New

A new record may be created by selecting the entry form from the menu bar (which opens the form with a blank record) or by clicking the new button if you are already in a form. The new button is located with all of the buttons at the bottom of every entry screen.

Edit

All records are disabled for editing until the edit button has been clicked. Locked records can be edited only after clicking the unlock button. The user who locked the record is the only one who can unlock it.

Save

To save a record, click the save button.

Cancel

Unsaved changes to a record may be canceled while the record is in edit mode by clicking the cancel button. The record will be refreshed to its prior state, which may be a blank entry screen.

Delete

To delete a record, click the delete button. A pop-up window will appear asking you to verify that you want to delete the record. If you want to delete the record, click the OK button, otherwise click cancel and the record will return to its original state.

Lock

The lock button allows users to save high-quality, complete data. Other users cannot edit a locked record and its details. This feature should only be used when the current user has entered complete, superior quality data. If you are the user who locked a record, only you will be able to unlock the record to make additions or corrections. Other users will not have that option, but they will have the option of contacting you via email or contacting an administrator. Administrators and data managers have permission to unlock records for people who no longer are available to unlock the record themselves, so a record will never be permanently locked.

Unlocking

The Data Entry Controls for a Locked Record

Unlocking allows a record to be edited. A locked record usually has high-quality, complete data. Only the user who locked a record and data management staff have permission to unlock a record. If you need to unlock a record that has been locked by another user, click the envelope icon () next to the name of the person who locked the record (see the image above).

The Unlock Record Request email Form

Clicking the envelope icon() will launch a separate window where you can draft and send an email to the user who has locked the record. Your email address and the email address of the person who has locked the record will be populated once the window is open. In the subject section of the email, the default text will state “Locked Record in Caisis”, but this may be edited. The your message section of the email will be blank for you to add information on the location/patient that the request is referencing. Once the email is complete, click the send button to have the request sent via email. If you decide that you do not want to send the email, simply close the window without sending the request.

Entering Data – the Audit Log

The Audit Log Fields

Every time a record is entered or edited, information about the user making these changes is displayed at the bottom of the entry forms panel. The following items are shown: Entered By, Updated By, and Locked By, each with the time the action was completed. When a record is first entered into the database, the user’s name and the time that the record was entered is stored for tracking purposes within the database. If another user or the same user makes changes to the record, then that user’s name and entry time is added. The Entered By: information is always based on the original record, while the Updated By: information can change several times. Although the information is not displayed on the screen, these changes and the original records are all stored in audit logs. When a record is changed in a table, a copy of the prior record or table row is added to the corresponding audit log for that table. The audit logs are in place, so that no record or change is ever lost and to ensure that Caisis meets the requirements of Title 21 Code of Federal Regulations Part 11. For more information, visit the FDA’s Part 11 website: http://www.fda.gov/ora/compliance_ref/part11/

Navigating the Patient Data Screen

There are 2 ways to navigate the Patient Data tab – you may use the View: pull down menu in the DVV list or you may use the drop down menus.

The Patient Summary Screen

The first screen visible in the Forms section is the Summary screen. The Summary screen pulls select information from the database to provide a quick summary of the patient’s history and treatment course.

Navigational Menus

Across the top of this section are a series of drop down menus: Patients, Encounters, Procedures, Therapies, Diagnostics, and Outcomes. Each one of these menus has a series of links to data entry forms including the medication, surgery, and allergy forms. Clicking any of these links will refresh the right side of the Patient Data section to display a specific form for data entry. The DVV list will be filtered to display records of the same type previously entered for this patient. When a record is entered and saved, it will be visible in chronological order on the DVV list.

The Date Variable Value (DVV) lists described

The DVV list displays on the left side of the screen. It provides a chronological overview of the patient's history. There is an alphabetical pull down menu within the DVV list in the from which you may see a filtered selection of information on this patient. Selecting an item from this list will display its detail in a form on the right side of the screen. These forms are explained below.

Most Relevant

This is a select view of the most relevant information for this patient in Caisis.

List All

This is a list of all the information for this patient in Caisis.

Actions

This is a view of all the documented actions taken for managing the data of this patient. It shows the date of the action, a brief description of the action taken, and the status of the action (pending or complete).

Allergies

This view lists each of the patient’s allergies and their corresponding response.

Biopsies

This view lists information on all the biopsies for this patient.

Brachytherapy

This view lists information on all brachytherapy procedures for this patient.

Categories

This view lists what categories a patient has been assigned to within the database.

Clinical Stages

This view lists the stage of a patient’s disease at different points in time.

Comorbidities

This view lists the details about each of the patient’s comorbidities.

Consent

This view lists the details about the consents a patient has received, signed, or rescinded.

Cytologies

This view lists all cytologies on a patient, including bladder washings, voided urines, cerebro-spinal fluids, fine needle aspirates, etc.

Diagnostics

This view lists a complete list of diagnostic studies done for the patient including the procedure date, type, and result.

Dietary Intake

This view lists the dietary intake for a patient at different points in time.

Encounters

This view lists each clinical encounter for this patient. It includes physical exams, reviews of symptoms, and digital rectal exams.

Endoscopies

This view lists each endoscopic procedure recorded for this patient. NOTE: TURPs are usually found under Prostate Biopsy rather than Endoscopy.

Family History

This view lists the patient’s family history of cancer; particularly what family member had what type of cancer.

Identifiers

This view lists the various identifiers used to track a patient within the database: the type of identifier used and the specific value. This list may include hospital numbers, study identifiers, or other identifiers and is not limited.

Lab Tests

This view lists each of the patient’s lab tests including the date it was done, the units of measurement, and the result. Using the filter tool at the bottom of the screen you may select one or more types of lab tests and display only those tests, or remove the filter again and see all lab tests.

Medications

This view lists the dates, schedule, dosage, and other details about each medication the patient has taken.

Medical Tx

This view lists each of the medical therapy treatments received by the patient including the start date, type of agent, and dosage.

Physicians

This view lists all doctors involved in a patient’s case and the role of each physician.

Procedures

This view lists each of the general surgical treatments done on the patient (other than major cancer surgeries).

Prostatectomy

This view lists basic information about the radical prostatectomy, such as the procedure date, surgeon, Gleason score, lymph node and margin status.

Protocols

This view lists a complete list of Protocols that a patient has been registered to including a short title, the enrollment date and the most recent activity.

QOL Therapy

This view lists the quality of life interventions of the patient such as treatments for potency or continence.

Radiation Tx

This view lists each of the radiation therapy treatments performed on the patient including the Start Date, Radiation Type, and Dosage information.

Social History

This view lists a link to the social history page where you will find information on the patient's drinking, smoking and social history.

Status

This view lists date and clinical status including progression of disease and disease states.

Surgeries

This view lists date and type of surgery for all the surgical procedures performed on the patient. This includes prostatectomies, cystectomies, orchiectomies, etc. and any procedures related to the surgeries (such as PLND with RP).

Surveys

This view lists date, survey name, and overall score (if appropriate) of all surveys recorded for a patient, including surveys about continence and potency such as the IIEF and IPSS.

Toxicities

This view lists the date and type of adverse event or toxicities from a medication, surgery, or other therapy.

All Treatments

This view lists the date and type of all treatments including medical therapies (i.e. chemotherapy, androgen suppression), surgeries, radiation therapy, and brachytherapy.

Missing Items

This view lists any items that had been marked as pending and with dates in the past.

Pending Items

This view lists any items marked as pending.