A Systematic Review to Evaluate Patient-Reported Outcome Measures (PROMs) for Metastatic Prostate Cancer According to the COnsensus-Based Standard for the Selection of Health Measurement INstruments (COSMIN) Methodology.

Patient-reported outcome measures (PROMs) represent important endpoints in metastatic prostate cancer (mPCa). However, the clinically valid and accurate measurement of health-related quality of life depends on the psychometric properties of the PROMs considered.

To appraise, compare, and summarize the properties of PROMs in mPCa.

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 European network of excellence for big data in PCa).

The most frequently used PROMs in RCTs of patients with mPCa were the Functional Assessment for Cancer Therapy-Prostate (FACT-P) (n = 18), the Brief Pain Inventory-Short Form (BPI-SF) (n = 8), and the European Organization for Research and Treatment of Cancer quality of life core 30 (EORTC QLQ-C30) (n = 6). A total of 283 abstracts were screened and 12 full-text studies were evaluated. A total of two, one, and two studies reported the psychometric proprieties of FACT-P, Brief Pain Inventory (BPI), and BPI-SF, respectively. 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 by Cronbach's α 0.70-0.95).

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 in a very limited number of studies.

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.

Cancers. 2022 Oct 19*** epublish ***

Maria Monica Ratti, Giorgio Gandaglia, Elena Silvia Sisca, Alexandra Derevianko, Eugenia Alleva, Katharina Beyer, Charlotte Moss, Francesco Barletta, Simone Scuderi, Muhammad Imran Omar, Steven MacLennan, Paula R Williamson, Jihong Zong, Sara J MacLennan, Nicolas Mottet, Philip Cornford, Olalekan Lee Aiyegbusi, Mieke Van Hemelrijck, James N'Dow, Alberto Briganti

Department of Medicine and Surgery, Vita Salute San Raffaele University, 20132 Milan, Italy., Unit of Urology/Division of Oncology, URI, IRCCS San Raffaele Hospital, 20132 Milan, Italy., Department of Clinical and Health Psychology, IRCCS San Raffaele Hospital, 20132 Milan, Italy., Translational and Oncology Research (TOUR), Faculty of Life Sciences and Medicine, King's College London, London WC2R 2LS, UK., Academic Urology Unit, University of Aberdeen, Aberdeen AB24 3UE, UK., MRC North West Hub for Trials Methodology Research, University of Liverpool, a Member of Liverpool Health Partners, Liverpool L7 8XP, UK., Real World Evidence, Global Medical Affairs Oncology, Whippany, NJ 07999, USA., Department of Urology, University Hospital, 42055 St. Etienne, France., Liverpool University Hospitals NHS Trust, Liverpool L69 3GA, UK., Centre for Patient-Reported Outcomes Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.

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