Tip of the Week Archive

If 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:

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:

Example 1:

Unacceptable Outcome Measure:

• Outcome 1: “CTP”
• Description: “Cirrhosis will be assessed at baseline.”

Acceptable Outcome Measure: 

• Outcome 1: “Severity of Cirrhosis as Assessed by Child-Turcotte-Pugh (CTP) Classification”

• 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.

• ”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.”