Tip of the Week Archive

Addressing Common PRS Comments:  

“The Outcome Measure Title and Description do not appear to provide sufficient information to understand what will be assessed.”

 

If an Outcome Measure title and description do not contain enough information for the general public to understand the measurement, PRS will reject the record with the following “Major Issue” comment:

 

“The Outcome Measure Title and Description do not appear to provide sufficient information to understand what will be assessed.”

 

To address this, edit the Outcome Measure so that it thoroughly describes the measurement in non-technical language. Be sure to include:

• Information about WHAT is being measured, not WHY it is being measured. Avoid phrases like “To assess…” “To examine…” etc.
• The full name of the measurement or the measurement tool, not just the abbreviation
• The unit of measurement (i.e. mm, kg, score, rate of…, count of participants with…, etc.)
• If using a scale or score, include:

• What it measures
• Minimum/maximum 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 (etc.) to come up with a final score, describe that. For example, a questionnaire in which 10 tasks are rated 1-5 in difficulty, and the score is the average of all 10 responses.

 

Example 1:

Unacceptable Outcome Measure:

• Outcome 1: Satisfaction with exercise program
• Description: The satisfaction of participants with their assigned exercise program

Acceptable Revision:

• Outcome 1: Satisfaction with Exercise Program
• Description: Participant’s satisfaction with their assigned exercise program as assessed using a 5-point Likert scale. Scores range from "very unsatisfied" (1) to "very satisfied" (5).

 

Example 2:

Unacceptable Outcome Measure:

• Outcome 1: AKI
• Description: AKI will be determined via AKIN assessment

Acceptable Revision:

• Outcome 1: Rate of Acute Kidney Injury (AKI)
• Description: The AKIN scale will be used to assess the presence and severity of acute kidney injury (AKI). The AKIN is a classification/staging system of acute kidney injury developed by the Acute Kidney Injury Network (AKIN) which uses changes in serum creatinine (SCr) and urine output to assess AKI. Stages of acute kidney injury are defined as 1, 2, or 3, with 3 indicating the most severe AKI.

 

Example 3:

Unacceptable Outcome Measure:

• Outcome 1: To Determine Physical Function
• Description: The primary outcome is to determine if the surgery improves physical function in patients.

Acceptable Revision:

• Outcome 1: Change in Physical Function as assed using the WOMAC Scale
• Description: Participant-reported physical function post-surgery will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC assesses pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis. Possible scores range from 0-96. Total score is computed by summing three subscales: pain (range 0-20), stiffness (range 0-8), and functional limitations (range 0-68), then dividing by total points possible. Higher scores indicate worse pain, stiffness, and functional limitations.