What Are Patient-Reported Outcomes?
Patient-reported outcomes (PROs) are one of the four types of clinical outcomes assessments (COAs).
The four types are:
- Patient-Reported Outcomes (PROs)
- Clinician-Reported Outcomes (ClinROs)
- Observer-Reported Outcomes (ObsROs)
- Performance Outcomes (PerfOs)
PROs use questionnaires (both online and on paper) to ask what is important to the patient about their health and well-being. The answers come directly from the patient without interpretation by a clinician, family member, observer or anyone else.
PROs questionnaires have been developed by experts in order to capture patient information consistently and accurately. Using PROs, patients assign a value to what they are being asked to report. For example, PRO questionnaires may ask how a disease or treatment affects the patient’s severity of symptoms.
PROs support improved communication as we all work together to improve cancer treatment through a better understanding of what does and does not work for the patient.
PROs provide an important voice for the patient to share their experience throughout the cancer journey.
- They support a partnership between the patient and their clinical team through improved communication about treatment outcomes
- They provide important information about side effects and tolerability of new treatments
- They can guide treatment decisions through better understanding of changes in symptoms and how a patient feels and functions during a clinical trial
- They can support development of new cancer therapies that may help other patients
- They can improve patient outcomes, care quality and patient satisfaction
The use of PROs in clinical trials is supported by both patient advocacy groups and regulatory agencies.
In a clinical trial, PROs can measure how well tolerated a treatment is. This is done with questionnaires about symptomatic adverse effects, the overall burden of symptoms and physical functioning.
Data from PROs in clinical trials can be used to measure the overall burden of disease and treatment-related symptoms. They can also look at a global view of health and measure any changes in health while on the treatment.
Frequently Asked Questions
1. Is participation in PROs questionnaires optional for my clinical trial?
PROs may be optional in some trials, but we believe completion of these questionnaires is an important aspect of your care and supports understanding of treatment impact for all who participate.
2. Will I be able to review my PROs with my clinicians while I am participating in the trial?
Yes! One benefit of completing PROs while on a clinical trial is that it can encourage conversations with your clinicians about how you are feeling and functioning during the study.
3. Who will see my responses on questionnaires, and will they be confidential?
The clinical team involved in your direct care will be able to see your questionnaire responses. Other researchers may see your answers, but your name will not be shared.
4. What happens if I do not feel well enough to fill out my PROs?
The questionnaires can be an important way to communicate how you are feeling to your clinicians, even when you are not feeling well. Many trials have a window for questionnaire completion and the team will be there to support you. If you are experiencing severe symptoms, please call 911 or seek emergency care.
5. How long will the questionnaires take to complete and how often will I be asked to do them?
The amount of time it takes to fill out questionnaires and how often you must fill them out will depend on the type and number included in your clinical trial. Typically, each questionnaire takes less than 5 minutes to complete on average.
6. Will my participation with PROs help other patients?
Yes! Your participation with PROs during your clinical trial will provide important information about how cancer treatments make you feel and what side effects you experience. This information may benefit future patients who have your disease.
7. Where can I go to learn more about PROs?
For more information about PROs, please contact us at CCR.OPCORe@mail.nih.gov.