Cancer-specific Reference Values Specified for PROMIS Domains
Use of patient-reported outcomes is increasing as endpoints in clinical trials.
Reference values for the Patient-Reported Outcomes Measurement Information System (PROMIS) domains have been established by a population-based study published in the Journal of Clinical Oncology.1
Use of patient-reported outcomes (PROs) is increasing as endpoints in clinical trials. Reference values may improve the understanding of differences in specific cancer populations. The purpose of this study was to develop reference values of 8 PROMIS domains among patients.
The study included 5284 patients with cancer newly diagnosed between 2010 and 2012; data were obtained from the SEER Program. Cancer types included prostate, colorectal, non-small cell lung, non-Hodgkin lymphoma, breast, uterine, and cervical.
Patients completed mailed surveys 6 to 13 months after their diagnosis. The PROMIS T-score metrics were analyzed, with 50 representing the reference value of the US general population.
Patients with cancer reported pain interference (52.4), fatigue (52.2), and physical function (44.1) as significantly worse than the general population. Advanced disease was associated with poorer reference values than limited or no evidence of disease for physical function (41.1 vs 46.6, respectively), fatigue (55.8 vs 50.2, respectively), and pain interference (55.2 vs 50.9, respectively).
Patients with lung cancer and cervical cancer showed the greatest symptom burden.
According to the authors, “cancer-specific United States reference values enhance the understanding of the burden of cancer.” This information can inform policy issues, particularly the collection of PRO data and its use in clinical practice.
- Jensen RE, Potosky AL, Moinpour CM, et al. United States population-based estimates of patient-reported outcomes measurement information system symptoms and functional status reference values for individuals with cancer. J Clin Oncol. 2017 Apr 20. doi: 10.1200/JCO.2016.71.4410 [Epub ahead of print]