Screening Bias

Screening Bias allows the analyst to identify any large within-site changes in values between two visits to identify regression to the mean in assessing study entry criteria. Analysis are performed using paired t-tests.

An example for subjective criteria is when investigators score a patient at a screening visit and based on this score the patient meets eligibility to get in the study. However, when the patient comes back at the randomization visit, the "more objective" investigator scores the patient noticeably differently. Or, it can pick up noticeable differences between the start and end of a placebo run-in when things are not expected to change.

FDR p-values are calculated and the reference line is determined as described in How does JMP Clinical calculate the False Discovery Rate (FDR)?.

Note: JMP Clinical uses a special protocol for data including non-unique Findings test names. Refer to How does JMP Clinical handle non-unique Findings test names? for more information.

Note: xxTPT should not have any visit-specific information in it, or it is liable to prevent a match using BY variables.

The Report contains the following elements:

•	Screening Bias Volcano Plot: Shows a volcano plot used to find records where findings change significantly between one visit and the next.

Down Buttons

down buttons, provide you with an easy way to down into your data. The following down buttons are generated by this report:

•	Show Summary Statistics: Shows the rows of the data table for the selected points from the volcano plot. Clicking opens the following table:

General

•	Click to view the associated data tables. Refer to View Data for more information.

•	Click to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected sections.

•	Click to take notes, and store them in a central location. Refer to Add Notes for more information.

•	Click to read user-generated notes. Refer to View Notes for more information.

•	Click the Options arrow to reopen the completed report dialog used to generate this output.

•	Click the gray border to the left of the Options tab to open a dynamic report navigator that lists all of the reports in the review. Refer to Report Navigator for more information.