Abstracting Interventions - Include v4.4

You can search for, and select, interventions from a stored list of active intervention terms extracted from NCIt and link them to a trial. NCIt is an online database developed and maintained by the National Cancer Institute Enterprise Vocabulary Services. You can find more detailed information about NCIt at http://ncit.nci.nih.gov/.

Additionally, Protocol Abstraction provides a structure for describing drug, radiation, and surgical procedure details. It generates a description from values you provide for such parameters as dose, target site, frequency of administration, etc.

Trials can have multiple intervention records. Each record displays the following information about the intervention:

Intervention data definitions

1. Alternate names you record appear in the TSR and XML documents. ↩

Additionally, you can add, edit, reorder, and delete records.

 

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Adding Interventions

You can link interventions to a trial by searching for an intervention name from the current list of active records.
The terminology list is refreshed weekly.

How to Add Interventions

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Interventions. The Interventions page appears, with or without any intervention records displayed.

3. Click Add. The Add intervention page appears.
   

4. From the Intervention Type drop-down list, select the means of intervention for the trial. Valid intervention types are as follows.
   
   • Drug
   • Device (including sham)
   • Biological/Vaccine
   • Procedure/Surgery
   • Radiation
   • Behavioral (for example, Psychotherapy, Lifestyle Counseling)
   • Genetic (including gene transfer, stem cell, and recombinant DNA)
   • Dietary Supplement (for example, vitamins, minerals)

   • Other
     

5. To search for the name of the intervention, click Look Up.
   The Search Intervention window appears.
   
   

6. In the Intervention Name field, type part or all of the intervention name.

   Tip

   The system adds wildcards on both sides of the search string (the series of letters you type) for you implicitly. You can type wildcard symbols (% or *) between characters of the string as necessary.
   1. To include synonyms in your search in addition to preferred names, select the Include Synonym check box.
   2. To limit your search to exact matches only, select the Exact Match Only check box.
7. Click Search.
   The system searches for the intervention from both preferred names and synonyms (if selected) in the database, and returns a list of results.
   
8.  Scroll through the list to locate the intervention, and click Select.
   The selected intervention and any other names are displayed on the Add Intervention page.
   

9. Optionally, in the Intervention Description field, enter the name/description of the intervention. 

10. Click Save.
    The record is added to the trial and displayed on the Interventions page.

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Generating Drug, Radiation, Procedure, and Surgery Descriptions

Protocol Abstraction provides a structure for abstracting detailed descriptions of drug, radiation, and procedure/surgery interventions.

How to Generate Drug, Radiation, and Procedure/Surgery Descriptions

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Interventions. The Interventions page appears, with or without any intervention records displayed.
3. Click Add. The Add intervention page appears.

4. From the Intervention Type field, select Drug, Radiation, or Procedure/Surgery as appropriate.

   Tip

   Do not type an intervention description at this point. The system automatically populates the Intervention Description from information you provide in the next steps.

5. Follow the steps in Adding Interventions for instructions for searching for, and selecting, interventions.
   The Interventions page expands to display a Drug Information, Radiation, or Procedure Information section, depending on your selection.
   
   
   
   
6. In the Drug, Procedure, or Radiation Information section of the page, enter the values in the text fields provided.
7. To provide values for the parameters that require harmonized terms (the gray fields), click Look Up.
   The Search window appears .
   
   

8. Type your search criteria in the field(s) provided, and then click Search. If the information you are abstracting includes a range, for example, dose range, you can provide the lower limit without providing the upper limit. However, do not provide the upper limit of a range unless you also include a lower limit.

   You must type at least one character in any of the search fields.

   The Search window displays the result(s) of your search.
   

9. In the search results list, locate the preferred item, and then click Select.
10. Once you have provided information for all relevant fields, click Generate.
    The information you provided is displayed in the Intervention Description field.
    
11. Click Save.

 

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Editing Interventions

You can edit trial descriptions. However, if you need to change the intervention type or name, you must delete the record and create a new one with the correct information. See Deleting Interventions.

How to Edit Intervention Records

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Interventions. The Interventions page appears.
   
3. In the Edit column for a given record, click the Edit (pencil) icon.
   The Edit Intervention page appears.
   
4. Edit or enter the intervention description, and then click Save.
   If you edit a drug, radiology, or procedure intervention, the Edit Intervention page displays the original form for the record.
    
   
5. To edit the intervention description and/or details of drugs, radiation, and procedures/surgeries, follow the instructions in Adding Interventions.
6. Click Save.

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Reordering Interventions

You can change the order in which the interventions are displayed in the interventions table and in the TSR/XML documents.

How to Re-Order Intervention Criteria

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Interventions. The Interventions page appears, displaying all other interventions currently abstracted.
   
   
3. In any column other than  Edit or Delete, click and drag the record you want to move to a new location in the Interventions table. The record background changes color as you move the record.
   
   

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Deleting Interventions

When you delete interventions from a trial, you delete them from view, and can not recover them. If you delete a record accidentally, follow the instructions in Adding Interventions to add it back.

How to Delete Interventions

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Interventions. The Intervention page appears.
3. In the Delete column, select the check box for each record you want to delete, then click Delete. To delete all records, click Select All, and then click Delete.

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Managing Intervention Terms

You can import NCIt terms on demand if the term you require for abstraction does not exist in the CTRP database. Once imported, CTRP syncs the term with in the NCIt database automatically.

If a term does not exist (i.e., has not been published yet) in the NCIt, you can request the term directly from EVS. Once EVS curators have responded to your request, you can enter new term details when abstracting trials. Later EVS publishes the new term in the NCIt. Refer to Managing Disease and Intervention Terminologies.How to Manage NCIt Intervention Terminology

1. At the bottom of the Interventions page, click Manage NCIt Terms.
   The Manage NCIt Terms menu contains options for managing intervention terms.
   

2. Follow the instructions in the following sections:

• Importing Intervention Terms

• Synchronizing Intervention Terms

• Requesting New Intervention Terms

• Entering Intervention Terms

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