Masked values in Pega Pharmacovigilance
Masked values provide coded reasons why data element values in E2B (R3) reporting are missing or incomplete. When an XML report is generated, the application populates the file with a code for a given attribute value. If the attribute is not associated with a masked value, the application populates the report with the original value.
The following table lists codes that are part of the HL7 masked value categorization:
| Code | Full name | Definition |
|---|---|---|
| NI | No Information | The default value. |
| MSK | Masked | The information is available but is not revealed due to security concerns or other reasons. |
| UNK | Unknown | The value is applicable but not known. |
| NA | Not Applicable | The value does not apply to the subject (for example, the attribute is gender-specific). |
| ASKU | Asked But Unknown | The information is sought but is unknown (for example, the patient did not know the answer). |
| NASK | Not Asked | The information was not sought. |
| NINF | Negative Infinity | The value results in negative infinity. |
| PINF | Positive Infinity | The value results in positive infinity. |
Pega Pharmacovigilance provides a common interface for each entity in E2B (R3) to capture masked values for each attribute. Entities are data types, for example, primary sources (reporters), a patient, or a patient's medical history. Entities contain attributes, for example, the patient's first name or last name.
When an E2B (R3) report is generated, the system checks for a masked value code that is associated with a given attribute. If the system finds such a code, the code is populated in the E2B (R3) XML file. If the system does not find a code for a given attribute, the original value is populated.
To address masked value requirements, the E2B (R3) data element supports fall into the following groups:
- Data elements with only one possible masked value – The E2B (R3) report requires a fixed code for data elements with one possible masked value. Based on E2B (R3) specifications, the application populates the appropriate codes for these data elements, for example, NI or UNK. For details, see the activities and data transforms that are called from the GenerateReportE2BR3 activity in the PegaLS-FW-AECPFW-Work-Reports class.
- Data elements with multiple masked values – More than one masked value can be associated with these data elements and you can choose from the available codes.
The following rules manage masked values in E2B (R3) reporting:
- The Nullflavor Master List data table stores all possible masked value codes for entity attributes. You can select valid codes from a drop-down list when capturing event case details.
- The SelectedNullflavors page group property in the PegaLS-FW-AECPFW-Data- class stores masked values that are selected for particular entities. For example, masked values for reporter entities are set in the pyWorkPage.PrimarySource(1).SelectedNullflavors page group. If this page group contains entries for a department attribute, it is stored in pyWorkPage.PrimarySource(1).SelectedNullflavors(Dept).SelectedNullflavor.
- The Prepare<Entity>DataForE2BR3 data transform rules in the PegaLS-FW-AECPFW-Data-<Entity> classes that are called from the GenerateReportE2BR3 activity copy masked value codes from the SelectedNullflavors page group into the E2B (R3) XML stream.
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