Applications in Research
HealthMeasures can be used in clinical research settings, including clinical trials, observational studies, and comparative effectiveness research.
HealthMeasures in Drug Development
- HealthMeasures can be used as primary or secondary endpoints in clinical and observational studies on the effectiveness of treatment.
- HealthMeasures, particularly PROMIS, can measure symptomatic adverse events, physical function, and disease-related symptoms (e.g., dyspnea) as recommended for cancer clinical trials. Learn more>>
- Researchers and sponsors should review the evidence to support the context of use.
- Efforts are underway to seek qualification for PROMIS measures. Submissions are listed on the FDA’s website. Learn more>>
- Submissions to the FDA’s Clinical Outcomes Assessment (COA) Qualification Program includes PROMIS® Physical Function measures in sarcopenia and oncology and PROMIS Fatigue measures in multiple adult and pediatric patient populations.
- For publications and webinars on assessment of patient-reported outcomes (PROs) in children and adolescents, content validity in PRO instruments and good practices for outcomes research visit the website of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Evidence Supporting the Validity of HealthMeasures
HealthMeasures have substantial qualitative and quantitative evidence for their validity in a range of populations and for different purposes. Read more about validity for
Patient-Centered Outcomes Research Institute (PCORI) acknowledges the importance of the PROMIS initiative with extensive funding opportunities
From PCORI’s first funding announcement through the end of 2019, PCORI has awarded nearly $34 million to studies using PROMIS measures. In addition to a PROMIS-specific funding announcement in 2014 totaling $5 million in support, PCORI continues to recognize the importance of PROMIS by soliciting input on the future involvement of PROMIS’ methodology and measures within its research portfolio.
Results of the studies featuring PROMIS measures are available at www.pcori.org.