A Systematic Review to Evaluate Patient-Reported Outcomes Measures (PROMs) for Metastatic Prostate Cancer According to the COnsensus-based Standard for the selection of Health Measurement INstruments (COSMIN) Methodology

Introduction: Patient-reported outcome measures (PROMs) represent important endpoints in metastatic prostate cancer (mPCa). However, the clinically valid and accurate measure ment of Health-Related Quality of Life depends on the psychometric properties of PROMs considered. Objective: To appraise, compare, and summarize the properties of PROMs in mPCa. Evidence acquisition: We performed a review of PROMs used in RCTs including patients with mPCa using
Medline in September 2021, according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This systematic review is part of PIONEER (an IMI2 39 European network of excellence for big data in PCa). Results: The most frequently used PROMs in RCTs of patients with mPCa were Functional Assessment for Cancer Therapy-Prostate (FACT-P) (n=18), Brief Pain Inventory-Short Form (BPI-SF) (n=8) and European Organization for Research and Treatment of Cancer quality of life core (EORTC QLQ-C30) (n=6). A total of 283 abstracts were screened and 12 full-text studies were evaluated. A total of 2, 1, and 2 studies reported the psychometric proprieties of FACT-P, Brief Pain Inventory (BPI) and BPI-SF. FACT-P and BPI showed a high Content Validity, while BPI-SF showed a moderate Content Validity. FACT-P and BPI showed a high Internal Consistency (summarized Cronbach’s α 0.70-0.95). Conclusions: The use of BPI and FACT-P in mPCa patients is supported by their high content validity and internal consistency. Since BPI is focused on pain assessment, we recommend FACT-P, which provides a broader assessment of QoL and wellbeing, for the clinical evaluation of mPCa patients. However, these considerations have been elaborated on a very limited number of studies. Patient summary: In this paper, we review the psychometric properties of PROMs used with patients with mPCa to find the questionnaires that best assess patients’ QoL, in order to help professionals in their intervention and improve patients’ QoL. We recommend the use of BPI and FACT-P for their high content validity and internal consistency, despite the limited number of studies considered.