Patient reported outcome – PRO

Participating in a clinical trial? Ask about PRO-CTCAE, a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™)

When patients with cancer participate in clinical trials of new therapies, it’s usually the clinicians who assess and record the side effects that the patients experience.
Side effects experienced by participants in NCI-sponsored clinical trials are logged into the Common Terminology Criteria for Adverse Events (CTCAE) system, the standard lexicon for adverse event reporting in cancer trials.

But researchers have long wondered if creating a way for patients to document their own experiences during treatment would help to provide more complete and accurate information about symptomatic side effects that may be associated with new drugs or treatment regimens.

The NCI encourages the use the publicity available for use in PRO-CTCAE. It should be used and reported in conjunction with the CTCAE reports gathered by clinicians.
This tool allows reports on everything from blood test values to toothaches. It also includes many symptoms—such as nausea, anxiety, and nerve pain—that are by their nature personal and difficult for an observer to measure.

Read more:
https://www.cancer.gov/news-events/cancer-currents-blog/2017/patient-reported-outcomes-clinical-trials

Hugs
Marion