To ensure that your eCRF only displays for patients who meet specific study criteria, follow these steps.
This process involves creating categories for inclusion and exclusion criteria, assigning numeric values to responses, and setting up a dynamic variable that controls the visibility of the eCRF.
Step 1: Create Inclusion and Exclusion Categories
Navigate to Categories: On the left menu, click on Variables > Categories > New Category.
Create Categories:
Name one category "Inclusion Criteria" (with no parent category).
Name the other category "Exclusion Criteria" (also with no parent category).
Add Questions: All questions within these categories should be of the Yes/No type.
Step 2: Set Numeric Values for Responses
In Exclusion Criteria Category:
Click on each variable within this category.
Go to the Values tab.
Change the numeric value of "No" from 0 to 1, and "Yes" from 1 to 0. This ensures that a "Yes" response (indicating exclusion) contributes to the overall exclusion score.
In Inclusion Criteria Category:
No changes are necessary, as "Yes" should equal 1 and "No" should equal 0.
Step 3: Create an "Inclusion Score" Variable
Navigate to Variables: On the left menu, click on Variables > New Variable.
Create the Variable:
Name it "Inclusion Score".
Place it in a different category, ideally the one following the Exclusion Criteria in the CRF.
This "Inclusion Score" variable will typically calculate how many inclusion and exclusion criteria are respected for the study. For example, if there are 5 inclusion criteria and 3 exclusion criteria, it is expected that the inclusion score would be exactly 8 for a patient that is eligible.
Step 4: Calculate the Inclusion Score
Count Questions: Add up the total number of questions in both the Inclusion and Exclusion Criteria categories.
Set Up the Formula:
Go to Variables > All Variables > Inclusion Score.
In the Dynamic Variable tab, click Edit Formula.
Choose Formula, then click Change Formula.
Enter the total number of questions from both categories under "Number of Variables or Constants".
For each question, add it to the formula with a "+" in between.
Click Create Formula.
Activate Dynamics:
On the right side of the screen, click Activate Your Dynamics.
In the options, select Retrospective Mode, then click Activate My Dynamics.
A confirmation message will appear: "Your variable was successfully dynamized!"
Step 6: Apply the Filter to Relevant Categories
Navigate to Categories: select each category that should only be accessible when criteria are met.
Set Display Conditions:
In the Display Only If tab, choose Only Display If.
Click +Add Condition and create a condition based on "Inclusion Score"
The condition will ensure that the category is only displayed if the "Inclusion Score" matches the exact number of questions, indicating all criteria are met. For example "Inclusion Score = 8"
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