Clinical Research Glossary

Patient Reported Outcomes (PROs) Patient Reported Outcomes (PROs)

CDISC

The information that patients share about their own health or well-being to answer questions in a study.

Example of Patient Reported Outcomes (PROs) in a sentence

Patient Reported Outcomes are a way to hear directly from patients about their health or study experience.

More Info

Measures to collect Patient Reported Outcomes (PROs) includes how a participant feels during the study, such as mood, sleepiness, amount of pain, and adverse events. Participants can explain how the disease or the study treatment is affecting their ability to do things like exercising, sleeping, going to work, etc.

PROs might be collected with surveys, questionnaires, diaries, or interviews.

PROs are important because they allow patients to report directly how they feel, and not as observed by the doctor, researcher, or someone else.

PROs can often measure what is important to participants. Analyzing the data allows researchers to draw some conclusions about the outcome.

Other info to think about when joining a study

A study you decide to participate in may involve collecting patient reported outcomes (PROs). This may be listed in the consent form as something you need to do if you enroll in a study.

You may wish to ask how PROs will be collected because it could be from surveys, interviews, diary entries or another way not mentioned here. You may also want to clarify how much detail they want when you provide these answers.

Most PROs are not reviewed in real time so participants should not expect to hear back from the study staff about what was entered.

Version 2.0 September 2024

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