Tip of the Week - Comment: “The Measure Includes a Scale…”
Addressing common ClinicalTrials.gov comments
May 14, 2020If an Outcome Measure includes a scale or a score (for example, the Hamilton Depression Rating Scale, or Ham-D), but not enough information about the scale is included, the record may be rejected with the following comment:
“Major Issue: The Measure includes a scale. Please provide the following scale information…”
To address this, include the following information about the scale in the Outcome Measure description:
- The full name of the scale (not just the abbreviation)
- What it measures
- Minimum/maximum possible scores
- What do higher or lower scores represent? Are higher scores better or worse, and is there a “normal” range?
- If the scale measures several things and then sums or averages them to come up with a final score, describe how scores are combined. For example, a questionnaire in which 10 tasks are rated 1-5 in difficulty, and the score is the average of all 10 responses.
Unacceptable Outcome Measure:
- Outcome 1: “Depression”
- Description: “Ham-D score will be assessed at baseline.”
Acceptable Outcome Measure:
- Outcome 1: “Severity of Depression as Measured by the Hamilton Depression Rating Scale”
- Description: “The Hamilton Depression Rating Scale (Ham-D) is used for rating the severity of depressive symptoms. Possible scores range from 0 to 50, with higher scores indicating greater severity of depression.”
- Time Frame: Baseline
Tags:
clinicaltrials.gov_comments
outcome_measure