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Clinical Research: Outcome Measures

This guide is designed to be a resource for those conducting clinical research at UF. It includes tabs for resources, training, IRB, Safety and Ethics, NIH, Standards and Templates, and Professional Associations.

Outcome Selection

What do you think is meaningful and likely to change via your intervention in the proposed time frame?

Search the Core Outcome Measures in Effectiveness Trials database (link below) to see if there are core outcome set studies for your population of interest.

Find out if there are any outcomes recommended by expert panels for inclusion in clinical trials in your population. For example, for osteoarthritis, there is a 1996 paper entitled, "Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Results from a workshop." This spells out study design issues and recommends a core set of outcomes to include in clinical trials in those with osteoarthritis.

Keywords to try when searching PubMed and other databases for similar papers in your population: expert panel, task force, work group, working group OR the name of the research group for your population if known (e.g., OARSI)..


Outcome Measures

Are there accepted/expected measures you need to include?

What measures will allow you to draw comparisons to existing studies?

For the specific measure:

• Are there validation studies in your population?

• Multiple versions (number of items, scale format [Likert, NRS])?

• Are there MCID, MCII, PASS, norms available to give meaning?

• Minimal Clinically Important Difference (MCID)

• Minimal Clinically Important Improvement (MCII)

• Patient Acceptable Symptom State (PASS)

• Population norms (also check scoring manual)

Find the actual instrument

Read the actual questions to see if the instrument captures what you want

Also check whether any grouping of questions into subscales make sense

Be aware if there are multiple versions (e.g., 36-item vs. 12-item versions; 60-seconds vs. 90-seconds)

Also find the scoring manual/instructions in advance

Instrument is useless if you can't score it

Finding the questionnaire/inventory/index/scale

Title words in studies which often have the instrument questions listed: development, psychometric, reliability, validity, validation

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