Classifying Terms Manually

You resolve omissions—terms that TMS could not classify automatically—by manually classifying the term. The type of classification you can create, and the system's behavior after your classification, depend on how the dictionary is set up by your organization.

VTA

If the dictionary allows only unique dictionary terms in the classification level, you classify an omission by creating a Verbatim Term Assignment (VTA). TMS automatically classifies all future occurrences of the same term to the same VTA. VTAs can be created as global or domain-specific, approved or not approved, misspelled or accepted.

Note:

VTAs cannot be assigned in the Maintain Action Assignment as an unanswerable action meaning you cannot add a verbatim to the Negative List when a VTA exists in the domain/global dictionary. Though you can create a VTI if a verbatim exists in the negative list.

VTI with Auxiliary Information

If the dictionary allows nonunique classification-level terms and includes auxiliary information for dictionary terms, like WHO-Drug Format C3, you can classify an omission by creating a Verbatim Term Individual (VTI). TMS automatically classifies all future occurrences of the same term with the same auxiliary information to the same VTI. VTIs are always approved and domain-specific. They can be misspelled or accepted.

VTI without Auxiliary Information

If the dictionary allows nonunique classification-level terms but has no auxiliary information—which is possible for MedDRA if nonunique dictionary terms are related to different higher-level dictionary terms—you classify an omission by creating a Verbatim Term Individual (VTI) in the All Verbatim Term Omissions tab. The classification applies only to the occurrence you code.

Note:

In TMS 5.3 release, a VTA and VTI may exist on the same verbatim term. This was not possible in previous releases. The VTI can be classified to a single occurrence of a source term. This allows a one time coding to a different dictionary term for a single source term.

Actions

If you cannot classify a term because the term itself is flawed, you can request that it be corrected by using an action.

1. From the Omission Management menu, open Classify VT Omissions.

2. Query for Unclassified Verbatim Terms

3. Do one:

• Look for a Good Match and Classify a Term

• Apply an Action to a Term if the verbatim term is faulty

In either case you can add an Informative Note to the term; see Creating an Informative Note for the Classification .

This section includes:

• Query for Unclassified Verbatim Terms
  
• Look for a Good Match
  
• Classify a Term
  
• Apply an Action to a Term
  
• Creating an Informative Note for the Classification
  
• DT Filter for Auxiliary Information
  
• The Above Button
  
• The Below Button
  

Query for Unclassified Verbatim Terms

Query for verbatim terms that TMS was not able to autoclassify or that a TMS user has declassified. These are called omissions.

• The Distinct Verbatim Term Omissions tab lists each distinct verbatim term omission that meets your query criteria. If the same term has been entered for ten patients, the term is displayed once.
• The All Verbatim Term Omissions tab lists every source term—verbatim term occurrence—that meet your criteria. If the same term has been entered for ten patients, all ten occurrences are displayed. Additional information about each occurrence is also displayed. Query in the Distinct tab, select the term, and view all occurrences in the All tab.

Action and Note Indicators

In both Verbatim Term Omissions tabs an "A" icon appears beside verbatim term omissions that have an associated Action.

An "N" icon indicates that there is a note associated with the term.

Figure 10-1 Figure 10-1 Action Indicators in the Distinct Verbatim Terms Tab

To query for unclassified verbatim terms:

1. From the Omission Management menu, select Classify VT Omissions. The Classify VT Omissions window opens.
2. (Optional) Select the Omission Filter settings you want to use for this session. See Setting Filters and DT Filter for Auxiliary Information for more information. To filter again, click the Filter or DT Filter button.

   TMS displays the query results in the Distinct Verbatim Term Omissions tab.

3. In the Distinct Verbatim Term Omissions tab, select a verbatim term.
   • If the dictionary has nonunique terms in the classification level and auxiliary information, like WHO-Drug Format C, open the All Verbatim Term Omissions tab. When you select a term, its auxiliary information is displayed at the bottom of the tab.
   • If the dictionary has nonunique terms in the classification level and no auxiliary information, you have two choices:
     • Select a term in the Distinct Verbatim Term Omissions tab. The classification you make applies to all existing occurrences of this term.
     • Select a term in the Distinct Verbatim Term Omissions tab and click the All Verbatim Term Omissions tab to see all occurrences of the term. Select an occurrence. The classification you make applies only to this occurrence.
   • If the term is flawed in such a way that it cannot be classified, apply an action to it. See Apply an Action to a Term.
   • Otherwise, proceed to Look for a Good Match.

Look for a Good Match

Search for a dictionary term or VTA to which to classify the verbatim term. TMS displays classification level dictionary terms and VTAs in the bottom block. Use one or more of the following methods to find a good match, and then highlight it.

1. Highlight the term you want to classify in the Distinct or All Verbatim Term Omissions tab above.
2. If the term's Search field has a value in the upper block, double-click the term. In the Classifications tab, TMS displays the candidate terms found during Autoclassification by the Search Object algorithm listed in the Search field. One of these is likely to be a good match for the verbatim term.

   If so, click Classify VT. If not, continue to search as follows.

3. Select one or more of the following in the Classifications block to narrow your query results:

   • Query

     • Select Standard to conduct a standard Oracle query, using the wildcard % for multiple characters and _ for single characters.

     • Select Context to conduct a query using Oracle interMedia Text retrieval capabilities. See Querying in Windows for more information.

   • Candidate?. If the Candidate checkbox is displayed for a selected omission record and the checkbox is selected, the Classification results display the matching term(s) from the search object order in the Classifications tab.

     Note:

     The Candidate? checkbox replaced the Search Type drop-down list in the TMS 5.3 release.

   • Dictionary Term and Level. If a VTA is selected in the Classifications block, TMS displays one of the following in the Dictionary Term and Level fields:

     • If you have not defined a Dictionary Term Display Procedure, the Dictionary Term field shows the term to which the selected VTA is mapped.

     • If you specified a procedure in the Dictionary Term Display Procedure field in the Define Dictionaries window, the Dictionary Term field shows the term yielded by this procedure, and the Level field displays that term's level. See Writing a Procedure to Change the Dictionary Display.

   • At the bottom of the Classifications tab, select either Current or All data. If you select All, you see dictionary terms and VTAs that have been deleted as well as current ones.

   • DT (Dictionary Terms). At the bottom of the Classifications tab, select either:

     • No to see only VTAs.

     • All to see all dictionary terms that match the other criteria.

     • Approved to see only approved dictionary terms that match the other criteria.

     • Not Approved to see only unapproved dictionary terms that match the other criteria.

     Note:

     Depending on the Non Appr DT setting for the current dictionary/domain combination, you may or may not be able to classify a verbatim term to a nonapproved dictionary term. See Assigning a Dictionary to a Domain for more information.

   • VTA. At the bottom of the Classifications tab, select either:

     • No to see only dictionary terms.

     • All to see all VTAs that match the other criteria.

     • Approved to see only approved VTAs that match the other criteria.

     • Not Approved to see only unapproved VTAs that match the other criteria.

     Note:

     VTIs are not displayed in the Classifications tab.

   • Click the DT Filter button to filter on VT auxiliary information, if any. See DT Filter for Auxiliary Information.

4. Execute the query by pressing F8 or selecting Execute from the Query menu. Results appear in this block.

   Note:

   In addition, you can use these buttons:

   • Highlight a term and click Above to see all of a term's relations in levels above. See The Above Button.

   • Highlight a term and click Below to see all of a term's relations in levels below. See The Below Button.

   • Reset the filter. See Setting Filters.

   • Filter on auxiliary information. See DT Filter for Auxiliary Information.

Classify a Term

To classify a term:

1. In the upper block, select the verbatim term to classify. In the Classifications tab, select the dictionary term or VTA to which you want to classify it.
2. The Global? box is selected or deselected by default according to settings elsewhere in TMS. You can override the default for a particular VTA:

   • Select the Global? box to make the VTA available in all domains where a Domain VTA for the same term does not exist.

   • Deselect the Global? box to make the VTA available only in the current domain.

3. If the verbatim term is spelled correctly, select Accepted from the VTA/VTI Subtype list. If not, select Misspelled. Future occurrences that are misspelled the same way will be classified the same way. Specifying whether the verbatim term is spelled correctly when you classify provides more accurate records.
4. Enter a Comment indicating why you chose this term for the classification.
5. Click Classify VT or Create VTI (available only when using the All Verbatim Term Omissions tab above).

   Classify VT allows you to create a VTA for the selected verbatim term.

   Create VTI allows you to create a VTI for the selected source term in the All Verbatim Term Omissions tab.

   TMS enters the repository term to which you have linked the verbatim term in the Dictionary Term field in the upper block.

   Note:

   If you make a mistake during manual classification or a dictionary term is added that is a better match for a classified verbatim term, you can reclassify the term (see Reclassifying and Declassifying Verbatim Terms).

Apply an Action to a Term

If you cannot classify a term, it may be appropriate to assign an Action to it instead. Use actions in the following situations:

• If the verbatim term is flawed, assign an Action to the term requesting that the term be fixed. TMS sends the Action text back to the external source system. In Oracle Clinical, the next Batch Validation creates a discrepancy for the question response with the Action text as the comment and the TMS user (you) as the creator of the comment. See Answerable Actions for more information.

  Approval of Answerable Action assignments may be required for particular dictionary domain; see Approving Action Assignments.

• You may need to send a message to the external system that does not require a response, or you may not have the resources to support a dialog. See Unanswerable Actions.

• If you need to speak to your supervisor or do research before you can classify a term, you can assign an Action to the term that says you are working on it. When other coders see the Action text, they will know not to duplicate your efforts. See Internal Actions.

You must select an Action that has already been defined (see Defining and Using Actions). Actions apply to all occurrences of the same verbatim term omission (VTO) in the same dictionary/domain combination.

To send a message to the external system about a single occurrence of a verbatim term, you can use a discrepancy message.

For more information, see:

• Applying an Action
  
• Applying a Discrepancy Message
  

Applying an Action

To apply an Action to a verbatim term:

1. In the top block of the Classify VT Omissions window, query for the verbatim term to which you want to apply an Action. Select the term.
2. In the bottom block, click the Distinct VTO Actions tab to open it.
3. From the Action drop-down list, select the Action you want to apply to the omission. TMS displays the Action type and the default Action text in the corresponding fields to the right; see Action Types. You can modify the Action text if necessary.

   TMS displays only actions that are valid options for the current user. TMS displays only Internal Actions and Unanswerable Actions to users without the Approve or Reclassify privilege or the overriding profile setting. Users with the Approve privilege, or Reclassify privilege, or overriding profile setting can see all active actions in the drop-down.

4. Click Apply Action. TMS assigns the Action to the term and lists the Action in the lower part of the tab. The action applies to all occurrences of the verbatim term.

   Note:

   If you are working in a dictionary with nonunique terms in the classification level, the system does not apply the action to occurrences of the verbatim term that have been classified to a VTI. For example, if Tylenol with Country equal to France has been classified but Tylenol with Country equal to any other value has not been classified, the action is not applied to Tylenol with Country equal to France but is to all other occurrences of Tylenol.

5. Save.

Applying a Discrepancy Message

To send a message about a single verbatim term occurrence to the external system, use a Discrepancy Message. This may be helpful if an external system user responds to an Answerable Action for a particular verbatim term occurrence.

1. In the All Verbatim Term Omissions tab, query for the verbatim term to which you want to apply a Discrepancy (or select the verbatim term in the Distinct Verbatim Terms tab, and then click the All Verbatim Term Omissions tab and select the correct occurrence).
2. In the appropriate verbatim term's row, click in the Omission Status field and press F9. The Omission Status dialog box opens, with a list of valid omission statuses.
3. Select the appropriate omission status. It must be a status that the external system will recognize.
4. Click OK. The Omission Status dialog box closes, and TMS populates the Omission Status field with your choice.
5. Enter a comment about this omission in the Action Text field.
6. Save. The next time you run the batch job for data exchange with the external system—Batch Validation in the case of Oracle Clinical—TMS sends this text to the external system.

Creating an Informative Note for the Classification

You can apply a note to the verbatim term or see the term's current status and note history by clicking the Status/Notes button or selecting Status/Notes from the Options menu. See Using the Status/Notes Pop-up Window for more information.

DT Filter for Auxiliary Information

Click the DT Filter button to search for dictionary terms using specific values in auxiliary information associated with dictionary terms; for example, in WHO-Drug C, Pharmaceutical Form, Strength, Strength, or Country.

Enter one or more values and click OK, or click VTO Autofill and the system displays the auxiliary values for the omission currently selected in the All Verbatim Term Omissions tab.

For example, to search for a dictionary term for the drug Carbamazepine marketed in Spain:

1. Click DT Filter.
2. Enter Spain in the Country field.
3. Click OK. The system displays the value "Spain" in the DT Filter line at the bottom of the tab.
4. Press F7 to enter query mode.
5. Enter Carbamazepine in the Term field in the Classifications tab.
6. Press F8 to execute the query. The system returns any existing dictionary terms for Carbamazepine that include Spain as the Country value.

The Above Button

Highlight a term in the Classifications block and select Above to see all the term's relations in higher dictionary levels. These are displayed in the tree structure with the lowest-level term at the top left and the highest-level term at the bottom right. Click any related term in the tree structure to see more information in the Contents tab. Click the Relations tab to see information about the relation between the highlighted term and the next lower term.

The Below Button

Highlight a term in the Classifications block and select Below to see all the term's relations in lower dictionary levels. These are displayed in the tree structure with the highest-level term at the top left and the lowest-level term at the bottom right. Click any related term in the tree structure to see more information in the Contents tab. Click the Relations tab to see information about the relation between the highlighted term and the next lower term.

In WHO-Drug C, the levels below contain the auxiliary information for the dictionary term.