Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2022 Oct 19;14(20):5120.
doi: 10.3390/cancers14205120.

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

Maria Monica Ratti  1   2 , Giorgio Gandaglia  3 , Elena Silvia Sisca  2 , Alexandra Derevianko  2 , Eugenia Alleva  1 , Katharina Beyer  4 , Charlotte Moss  4 , Francesco Barletta  3 , Simone Scuderi  3 , Muhammad Imran Omar  5 , Steven MacLennan  5 , Paula R Williamson  6 , Jihong Zong  7 , Sara J MacLennan  5 , Nicolas Mottet  8 , Philip Cornford  9 , Olalekan Lee Aiyegbusi  10 , Mieke Van Hemelrijck  4 , James N'Dow  5 , Alberto Briganti  3
Affiliations
Review

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

Maria Monica Ratti et al. Cancers (Basel). .

Abstract

Introduction: 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.

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 European network of excellence for big data in PCa).

Results: 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).

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 in 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.

Keywords: COSMIN; PROMs; core outcome set; erectile dysfunction; metastatic; prostate cancer; prostatic neoplasms; quality of life.

PubMed Disclaimer

Conflict of interest statement

There are no conflict of interest.

Figures

Figure 1
Figure 1
Flow diagram for study selection.
See this image and copyright information in PMC

References

    1. Gandaglia G., Leni R., Bray F., Fleshner N., Freedland S.J., Kibel A., Stattin P., Van Poppel H., La Vecchia C. Epidemiology and Prevention of Prostate Cancer. Eur. Urol. Oncol. 2021;4:877–892. doi: 10.1016/j.euo.2021.09.006. - DOI - PubMed
    1. Cornford P., van den Bergh R., Briers E., Van den Broeck T., Cumberbatch M.G., De Santis M., Fanti S., Fossati N., Gandaglia G., Gillessen S., et al. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer. Part II-2020 Update: Treatment of Relapsing and Metastatic Prostate Cancer. Eur. Urol. 2021;79:263–282. doi: 10.1016/j.eururo.2020.09.046. - DOI - PubMed
    1. Ratti M.M., Gandaglia G., Alleva E., Leardini L., Sisca E.S., Derevianko A., Furnari F., Mazzoleni Ferracini S., Beyer K., Moss C., et al. PIONEER Consortium. Standardising the Assessment of Patient-reported Outcome Measures in Localised Prostate Cancer. A Systematic Review. Eur. Urol. Oncol. 2022;5:153–163. doi: 10.1016/j.euo.2021.10.004. - DOI - PubMed
    1. Terwee C.B., Mokkink L.B., Knol D.L., Ostelo R.W., Bouter L.M., de Vet H.C. Rating the methodological quality in systematic reviews of studies on measurement properties: A scoring system for the COSMIN checklist. Qual. Life Res. 2012;21:651–657. doi: 10.1007/s11136-011-9960-1. - DOI - PMC - PubMed
    1. Prinsen C.A.C., Mokkink L.B., Bouter L.M., Alonso J., Patrick D.L., De Vet H.C., Terwee C.B. COSMIN guideline for systematic reviews of Patient-Reported Outcome Measures. Qual. Life Res. 2018;27:1147–1157. doi: 10.1007/s11136-018-1798-3. - DOI - PMC - PubMed

LinkOut - more resources