Psychometric validation studies
PRO instruments are increasingly deployed in clinical trials and observational studies to measure the impact of a healthcare intervention on patients' quality of life, treatment satisfaction or preference. For these data to be meaningful and credible in the eyes of regulators and decision-makers there must be evidence that the PRO instrument has validity.
Oxford Outcomes is a market leader with long-established expertise in PRO validation. Our studies stand up to regulatory scrutiny and peer-review for publication. Oxford Outcomes validation studies have been successfully included in FDA submissions, and no Oxford Outcomes study has ever been rejected.
We undertake psychometric validation exercises on:
- New instruments.
- Modified instruments.
- Translated or culturally-adapted instruments.
- Instruments transferred to new media including ePRO format.
We have a broadly-skilled team of psychometricians, statisticians, and supporting researchers with expertise in instrument design, validation study design, analysis and interpretation of results.
Oxford Outcomes has the capability and international network to collect PRO data for validation purposes and have recently completed validation studies in several countries outside Europe and North America including: Malaysia, South Africa, Mexico and India.