Outcome Measures Using Scales/Scores
Jan 14, 2021If you are using a score or a scale as an Outcome Measure, you must include the following specific information about the score or scale in the Outcome Measure Description on ClinicalTriasl.gov:
- 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.
Use this template for an Outcome Measure that includes a Score or Scale:
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Template |
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. |
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Example |
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. |
If an Outcome Measure includes a scale or a score, but any of the required scale information is missing, the record may be rejected with the following comment:
| “Major Issue: The Measure includes a scale. Please provide the following scale information…” |
Example 1:
Unacceptable Outcome Measure:
- Outcome 1: “CTP”
- Description: “Cirrhosis will be assessed at baseline.”
Acceptable Outcome Measure:
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Outcome 1: “Severity of Cirrhosis as Assessed by Child-Turcotte-Pugh (CTP) Classification”
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Description: “The Child-Turcotte-Pugh (CTP) score measures cirrhosis severity. Possible scores range from 5-15, with higher scores indicating more severe cirrhosis and a worse outcome.
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”Time Frame: Baseline
Example 2:
Unacceptable Outcome Measure:
- Outcome 1: “Severity of symptoms”
- Description: “Clinical Severity Scores”
Acceptable Outcome Measure:
- Outcome 1: “Severity of Symptoms as assessed via Clinical Severity Scores”
- Description: “The Clinical Severity Score devised by Wang et al, measures respiratory distress in young children. Possible scores range from 0 to 12, with higher scores indicating worse outcomes.”
Example 3:
Unacceptable Outcome Measure:
- Outcome 1: “To determine participant satisfaction with exercise program”
- Description: “We will determine participants satisfaction with their assigned exercise program by asking participants to rate their program at the end of the study”
Acceptable Outcome Measure:
- Outcome 1: “Satisfaction with Exercise Program”
- Description: “Participant self-reported satisfaction with their assigned exercise program will be determined using a 5 point Likert scale.Possible scores range from 1 to 5, with higher scores indicating more satisfaction and a better outcome.”