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Tip of the Week Archive

Tip of the Week: Outcome Measure Checklist

Jun 11, 2020

Checklist for Entering Outcome Measures

When writing your Outcome Measures in a ClinicalTrials.gov record, please review the following:

Outcome Measures Check	Complete?
Outcome Measure Title & Description are specific Good Example: “Pain Levels as measured by Visual Analog Score (VAS) at 6 Weeks Post-Surgery” Unacceptable Example: “Discomfort After Surgery”
Outcome Measures are listed individually - Only 1 variable is assessed per Outcome Measure Good Example: “Days of Inpatient Hospitalization” Unacceptable Example: “Hospital Services Usage” with a description of “days of inpatient hospitalization and visits to ER”
Outcome Description describes WHAT is being measured, not WHY it is being measured Good Example: “Systolic Blood Pressure at Baseline” Unacceptable Examples: “To measure blood pressure”; “To determine efficacy”
If using a score or scale, include the full scale name, what it measures, the range of possible scores, and what higher or lower scores mean (i.e. whether a higher number = better or worse outcome)
Outcome Time Frame specifies the individual time point(s) (e.g. study visits) at which the measurement is being assessed/reported, not the overall duration of the study. If measure is time-to-event or similar, use an estimate or maximum time that the measurement is being collected Good Examples: “Baseline”, “Week 2”, “Up to 20 Minutes” Unacceptable Examples: “Duration of study”; “Hospital admission until discharge”
If NOT assessing a change in an Outcome Measure over time, each time point is listed as a separate Outcome Measure Good Examples: Outcome 1: “Visual Analog Scale (VAS) Pain Score at Baseline”; Outcome 2: “Visual Analog Scale (VAS) Pain Score at Week 6”
If assessing a change in the Outcome Measure over time, the title specifies “Change in [Outcome Measure]” Good Example: “Change in Visual Analog Scale (VAS) Pain Score”, Time Frame: “Baseline, Week 6”
Outcome Time Frames are spelled out (“16 Weeks”, not “16W”)
Outcome Measure Title, Description, and Time Frame are consistent with each other and with the rest of the record (e.g. if the Description says the measurement will be assessed at 3 weeks, the Time Frame specifies “3 Weeks”)
Outcome Measure title is outcome neutral (e.g. “change in…” vs. “decrease in…” or “improvement in…”)
Unit of measure is specified (mm, kg, score, rate of…, count of participants with…, etc.)
Outcome Measure titles are written in Title Case and do not end in a period
Acronyms are expanded on the first use and symbols are spelled out (e.g. % = “percent”)

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