The Unit of Measure field in the Outcome Measure Results Data Tables
Entering Results: Unit of MeasureDec 3, 2020
When you enter your results data into your Outcome Measure Data Tables, you’ll need to specify the Unit of Measure for your reported data.
The Unit of Measure is what is quantified by the data you entered in the Outcome Measure table (e.g., participants, mmHg). If you are reporting a value of “10” in your Outcome Measure data table, you can specify your Unit of Measure by answering the question “10 of what?” Does your data indicate a score of 10? 10 participants? 10 mg/kg?
In the example below, the Unit of Measure is consistent with the Outcome Measure description, and accurately indicates what is quantified by the data entered in the Outcome Measure Data Table.
Common Unit of Measure Pitfalls
- Make sure to report the Unit of Measure, rather than what you are measuring. If, for example, your Outcome Measure was “Systolic Blood Pressure at Baseline”, your Unit of Measure should probably be “mmHg”. If you entered a Unit of Measure of “Blood pressure” rather than “mmHg”, the record would be rejected with the following QC comment:
Major Issue: The Unit of Measure does not appear to be valid.
- The Unit of Measure needs to be consistent with the information you entered in the Outcome Measure title and description. In the example below, the Outcome Measure description specifies “minutes”, but the Unit of Measure entered is “Hours”. This record would be rejected with the following QC comment:
Major Issue: The Unit of Measure does not appear consistent with information in the Measure Title and/or Description.
- The Unit of Measure also needs to be logical in relation to the data values entered. In the example below, the Outcome Measure description and Unit of Measure both specify “Percentage of participants”, but the values (121, 133, 111) can’t actually represent “percent of participants”, since they are more than 100%. More likely, this is a count of participants. This record would be rejected with the following QC comment:
Major Issue: Information within the measure appears to be inconsistent.
Image Sources: Example Studies for Results Data Entry; Presentation to CTR Taskforce, September 2018 by Heather Dobbins of ClinicalTrials.gov.