Major Issue: “More than one outcome measure appears to be described”
Addressing common ClinicalTrials.gov comments:Feb 18, 2021
The ClinicalTrials.gov definition of “Outcome Measure” often differs from the outcomes researchers describe in their protocols. While a stated outcome in a protocol might include the assessment of several variables, an Outcome Measure described in a ClinicalTrials.gov record should be an individual variable or measurement used to assess the protocol outcome.
If an Outcome Measure includes multiple measurements or variables, PRS will reject the record with the following comment:
Major Issues: More than one outcome measure appears to be described.
Example: Unacceptable Outcome Measure
- Outcome 1: “Body composition”
- Description: “Body Mass Index (BMI) and Visceral Fat Index (as assessed by CT).”
Example: Acceptable Outcome Measures:
- Outcome 1: “Body Mass Index (BMI)”
- Description: “Body Mass Index (BMI) is a person’s weight in kilograms divided by the square of height in meters. Scores between 18.5 and 24.9 indicate a healthy weight.
- Outcome 2: “Visceral Fat Index (VFA)”
- Description: “The Visceral Fat Index (VFA) will be assessed using a CT scan. Scores range between 1 and 59. Scores between 1 and 12 indicate healthy levels of visceral fat. Scores of 13 and above indicate excessive, unhealthy levels of visceral fat.”
Exception: if a composite score of multiple measures will be used.Example: “Count of participants with either a BMI of 25 or higher or a VFA of 13 or higher at baseline.”