Calculating DCI and Interval Expectedness for Patients

In order to accurately reflect which DCIs and Intervals are expected for each patient in real time in RDC Onsite data entry, Oracle Clinical automatically recalculates expectedness in almost every situation where it might change for a patient.

There are just a few situations in which you should run the job manually.

For more information, see:

• Automatic Expectedness Calculation for Patients
  
• When and How to Run Expectedness Calculation Manually
  

Automatic Expectedness Calculation for Patients

In this section:

• Automatic Incremental Expectedness Calculation
  
• Automatic Full Expectedness Calculation
  

Automatic Incremental Expectedness Calculation

The incremental mode of the expectedness calculation job is sufficient for updating expectedness due to changes in patient data. It begins at the patient's earliest CPE with data changes that might impact expectedness—that is, data entered for a Question or DCM that is defined as a rule trigger.

The system automatically runs incremental expectedness processing during Manual Data Entry and Batch Data Load and Batch Data Delete.

Manual Data Entry - The system automatically runs incremental expectedness calculation during data entry in Oracle Clinical and RDC, updating the expectedness of DCIs and Intervals for the patient if required. This occurs when the user saves data.

In RDC it occurs at every data entry transaction and, if the patient requires recalculation, as soon as a user opens a CRF for a patient.

Batch Data Load and Batch Data Delete - For Batch Data Load and Batch Data Delete, the system performs the expectedness calculation immediately after completing the main transactions to minimize locking time. Each patient with modified data is processed by a separate transaction.

Other Types of Data Changes - The system also recalculates expectedness as follows:

• Mass Changes: Every Received DCI is a single transaction which includes the immediate expectedness calculation, if needed.

• Patient Transfers: All changes for a single Patient transfer are performed as part of the transfer transaction, including the processing of multiple patients in an ongoing transfer.

• Derivation Procedures: Oracle Clinical processes the changes for each Received DCI as a transaction. The expectedness calculation is performed as part of these transactions if the Derivation Procedure derives a trigger Question. This applies whether the Derivation Procedures are run in Batch Validation, Execute Single Procedures, or as Online procedures from RDC.

Automatic Full Expectedness Calculation

Full expectedness calculation performs a complete recalculation of expectedness, beginning at the patient's first CPE and discarding all previous results. The system uses it when a patient is assigned or reassigned to a DCI_Book.

Full mode is required and automatically run as follows:

• Immediately after a user assigns or reassigns patients to a DCI Book using the user interface

• At the end of batch validation in production mode, if batch validation detects patient book assignment changes made using a Validation or Derivation procedure. In addition, any Full processing that may have been left incomplete due to a system failure is detected and processed.

• At the end of an online Procedure execution that detects patient book assignment changes

• During the first data entry transaction (including opening a CRF in the RDC Surround) for any patient marked as requiring expectedness recalculation

Expectedness calculation is not run automatically in the following situations:

• For test mode patients after their assigned DCI Book is successfully revalidated, because this may happen many times in test mode during DCI Book definition

• Following a batch validation in test mode, even if patient book assignments have been changed

• In production mode, when an active DCI Book has been made Provisional and then reactivated

• When a patient was assigned to a different Book while "frozen" and is subsequently unfrozen

You may want to run expectedness calculation manually in these situations.

When and How to Run Expectedness Calculation Manually

In this section:

• When to Run Expectedness Calculation Manually
  
• How to Run Expectedness Calculation Manually
  

When to Run Expectedness Calculation Manually

Because the system runs expectedness calculation automatically each time patient data is updated and after patient book assignment changes, there are very few situations in which you need to explicitly calculate expectedness. They are:

• After activating an enhanced DCI Book that has patients assigned

• After "unfreezing" patients whose assigned book was activated while they were frozen

• After making an existing study flexible in the Clinical Study States window: you must then set any active books to Provisional and reactivate them, and then run Calc Expectedness in Test for all patients and all books. (If a nonflexible study has production data you cannot make the study flexible.)

In addition, if there is a system failure during a batch data load or batch data delete, expectedness calculation may not have completed. You may want to run the job manually. If you do not run the job manually, and if the book is valid, the system will run the job automatically for each patient during the next data entry transaction for the patient or the next batch validation.

Note:

Run Calc Expectedness in Test or Prod in the same situations for an Enhanced DCI Book with no rules defined as you would for a Book with rules to ensure that the correct CRFs are displayed for patients in RDC Onsite.

How to Run Expectedness Calculation Manually

The test and production modes of the job are available as follows:

• The test mode option is available if the DCI Book has a status of Active or a status of Provisional and a validation status of Warning or Success.

• The production mode option is available only if the DCI Book has a status of Active.

To run the job:

1. Select Calc Expectedness in Test or Calc Expectedness in Prod (to run on test or production patient data) from the Special menu in the Maintain Enhanced DCI Books window.
2. In the pop-up window, select one of the following:

   • All Patients: This option forces full expectedness recalculation for all patients. This option should never be necessary but is provided just in case.

   • Only Patients Requiring Recalculation runs full expectedness recalculation only on patients who have been identified as requiring recalculation: those who have been "unfrozen" since the DCI Books was last activated, or whose data expectedness has not been successfully calculated since the Book was last activated.

3. In the pop-up window, select one of the following:

   • Current Book Only

   • All Books in Current Study

4. Click OK. The job runs.

When the job finishes, a message appears saying whether or not the calculation job has run successfully.