What are patient-reported outcomes in clinical trials?

Patient-reported outcomes (PROs) are defined as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else” (Food and Drug Administration [FDA], p. 6).

How do you collect patient-reported outcomes?

Strategies for Collecting High-Quality Patient-Reported Outcomes

1. Set Clear Goals.
2. Use Validated Questions When Possible.
3. Avoid Multiple Interpretations of Questions.
4. Keep It Short and Sweet.
5. Ensure Patient Understanding.
6. Choose the Best Method for the Target Population.
7. Protect a Patient’s Right to Refuse.
8. Conclusion.

What are pro in clinical trials?

Patient-reported outcomes (PROs) are increasingly used in clinical trials to assess the impact of a medical treatment or intervention. PRO assess a range of outcomes including symptoms, functional health, well-being and psychological issues from the patients’ perspective, without interpretation by a clinician [1,2,3].

What is a patient-reported outcome measure?

The United States Food and Drug Administration’s (FDA) Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims defines a PRO① as “any report of the status of a patient’s (or person’s) health condition, health behavior, or experience with healthcare that …

How are Patient Reported Outcomes ( PROs ) used in clinical trials?

Background: Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice.

What are the pros and cons of clinical trials?

PROs play a significant role as study endpoints in the development and evaluation of new therapies [4]. The Patient-Centered Outcomes Research Institute (PCORI) recommends that the outcomes measured should include ones that patients notice and care about (e.g., survival, function, symptoms, health-related quality of life) [5].

What does FDA mean by patient reported outcome?

The U.S. Food and Drug Administration (FDA) defines a patient-reported outcome (PRO) as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else [1].” Patient-reported outcomes typically include…

What is the impact of pro trial data?

Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data.