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Understanding Study Days: Defining ICU Admission and Flow Sheet Timing for Data Collection

This guide clarifies the concept of Study Days in clinical settings, particularly focusing on the confusion surrounding ICU admission times and the timestamps on flow sheets. When a patient is admitted to the ICU after midnight but within the flow sheet period, it can lead to misinterpretation by the system about Study Day assignments. For example, an ICU admission on January 8th at 5:30 PM, with a flow sheet running from 7:00 AM to 6:59 AM, impacts data collection timelines. Understanding these definitions ensures accurate data gathering throughout the study period.

vernon-wiggins
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Understanding Study Days: Defining ICU Admission and Flow Sheet Timing for Data Collection

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  1. Study Days THE ISSUE: There is confusion around the definition of STUDY DAY and the date assigned by the computer in the eCRF. WHO DOES THIS IMPACT? Sites who have flow sheets that DO NOT run midnight-to-midnight. The confusion arises when there is an ICU admission time after midnight but before the end of the flow sheet.

  2. Study Day 1 Study Day 1 is the day & time of ICU admission to the END of your site’s flow sheet. EXAMPLE: Flow sheet: 07:00 to 06:59 ICU admit: 08-Jan-08 @ 05:30 The computer assigns Study Day 1: 08-Jan-08 This means you collect data from 08-Jan-08 at 05:30 UNTIL 08-Jan-08 at 06:59 Note: Study Day 1 is only 1 hr 59 min.

  3. ICU admit: 08-Jan-08 @ 05:30 STUDY DAY 1 08-Jan-08 at 05:30 UNTIL 08-Jan-08 at 06:59

  4. Study Day 2, etc. Subsequent study days are represented by the 24 hours period according to your flow sheet. The study day date assigned by the computer is the date at the end of your flow sheet EXAMPLE: Flow sheet: 07:00 to 06:59 ICU admit: 08-Jan-08 @ 05:30 Day 2: 08-Jan-08 at 07:00 UNTIL 09-Jan-08 at 06:59 Day 3: 09-Jan-08 at 07:00 UNTIL 10-Jan-08 at 06:59 Day 4: 10-Jan-08 at 07:00 UNTIL 11-Jan-08 at 06:59 Day 5: 11-Jan-08 at 07:00 UNTIL 12-Jan-08 at 06:59 ……etc

  5. Study Day 2 = 09/Jan/2008 You collect data from 08/Jan/08 @ 07:00 until 09/Jan/08 @ 06:59 Study Day 3 = 10/Jan/2008 You collect data from 09/Jan/08 @ 07:00 until 10/Jan/08 @ 06:59 Study Day 4 = 11/Jan/2008 You collect data from 10/Jan/08 @ 07:00 until 11/Jan/08 @ 06:59

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