Tip of the Week Archive

When entering results data for crossover studies, Arms/Groups typically need to be presented one way when entered into the Participant Flow and Baseline Characteristics, and then another way when entered into the Outcome Measure Data and Adverse Events modules.

• For the Participant Flow and Baseline Characteristics modules, present the arms PER SEQUENCE so that no one gets double-counted, and it’s clear how participants “flowed” through the study.

   

• For the Outcome Measure Data and Adverse Events modules, present the arms PER INTERVENTION so that you capture data for each intervention for each participant, and so that it’s clear what intervention participants were receiving when you collected your Outcome Measure data or when an adverse event occurred.

Example:

Let’s say you have a study in which you have enrolled 130 participants.

• 65 are randomized to receive intervention “Hypertena” for 2 weeks, then have a 2 week washout period, then receive a Placebo for 2 weeks.
• The other 65 randomized to receive the Placebo for 2 weeks, then have a 2 week washout period, then receive Hypertenafor 2 weeks.

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For the Participant Flow and Baseline Characteristics modules, you would present the Arms/Groups “PER SEQUENCE”:

• Arm 1: “Hypertena, then Placebo”
• Arm 2: “Placebo, then Hypertena”

You would then add Periods in the Participant Flow module to show how many participants started and completed each period of the study:

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For the Outcome Measure Data and Adverse Events modules, you would present the Arms/Groups “PER INTERVENTION”:

• Arm 1: “Hypertena”
• Arm 2: “Placebo”

Example: Outcome Measure 1: “Number of Participants with Response”