Template for writing Outcome Measures using a Score or ScaleJan 6, 2022
If your Outcome Measure will be assessed using a score or a scale, ClinicalTrials.gov requires that the Outcome Measure description include the following specific information: the full name of the scale/score, what it measures, the range of possible scores, and whether higher or lower scores indicate a better or worse outcome.
Use the following template to write an Outcome Measure Description that includes a Score or Scale, replacing the bracketed text:
- The [FULL NAME OF THE SCORE/SCALE] measures [WHAT IT MEASURES]. Possible scores range from [MINIMUM POSSIBLE SCORE] to [MAXIMUM POSSIBLE SCORE], with higher scores indicating a [BETTER/WORSE] outcome.
- The Hamilton Depression Rating Scale (Ham-D) measures the severity of depressive symptoms. Possible scores range from 0 to 50, with higher scores indicating a worse outcome/greater severity of depressive symptoms.
For help writing Outcome Measures or addressing QA comments, contact firstname.lastname@example.org.
Tags: clinicaltrials.gov outcome measure scale score