Updating and Integrating Core Outcome Sets for Localised, Locally Advanced, Metastatic, and Nonmetastatic Castration-resistant Prostate Cancer: An Update from the PIONEER Consortium

Katharina Beyer*, Lisa Moris, PIONEER Consortium, Michael Lardas, Muhammad Imran Omar, Jemma Healey, Sheela Tripathee, Giorgio Gandaglia, Lionne D.F. Venderbos, Eleni Vradi, Thomas van den Broeck, Peter Paul Willemse, Tiago Antunes-Lopes, Luis Pacheco-Figueiredo, Serenella Monagas, Francesco Esperto, Stephen Flaherty, Zsuzsanna Devecseri, Thomas B.L. Lam, Paula R. WilliamsonRakesh Heer, Emma J. Smith, Alex Asiimwe, Johannes Huber, Monique J. Roobol, Jihong Zong, Malcolm Mason, Philip Cornford, Nicolas Mottet, Sara J. MacLennan, James N'Dow, Alberto Briganti, Steven MacLennan, Mieke Van Hemelrijck

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Context: Harmonisation of outcome reporting and definitions for clinical trials and routine patient records can enable health care systems to provide more efficient outcome-driven and patient-centred interventions. We report on the work of the PIONEER Consortium in this context for prostate cancer (PCa). Objective: To update and integrate existing core outcome sets (COS) for PCa for the different stages of the disease, assess their applicability, and develop standardised definitions of prioritised outcomes. Evidence acquisition: We followed a four-stage process involving: (1) systematic reviews; (2) qualitative interviews; (3) expert group meetings to agree standardised terminologies; and (4) recommendations for the most appropriate definitions of clinician-reported outcomes. Evidence synthesis: Following four systematic reviews, a multinational interview study, and expert group consensus meetings, we defined the most clinically suitable definitions for (1) COS for localised and locally advanced PCa and (2) COS for metastatic and nonmetastatic castration-resistant PCa. No new outcomes were identified in our COS for localised and locally advanced PCa. For our COS for metastatic and nonmetastatic castration-resistant PCa, nine new core outcomes were identified. Conclusions: These are the first COS for PCa for which the definitions of prioritised outcomes have been surveyed in a systematic, transparent, and replicable way. This is also the first time that outcome definitions across all prostate cancer COS have been agreed on by a multidisciplinary expert group and recommended for use in research and clinical practice. To limit heterogeneity across research, these COS should be recommended for future effectiveness trials, systematic reviews, guidelines and clinical practice of localised and metastatic PCa. Patient summary: Patient outcomes after treatment for prostate cancer (PCa) are difficult to compare because of variability. To allow better use of data from patients with PCa, the PIONEER Consortium has standardised and recommended outcomes (and their definitions) that should be collected as a minimum in all future studies.

Original languageEnglish
Pages (from-to)503-514
Number of pages12
JournalEuropean Urology
Volume81
Issue number5
DOIs
Publication statusPublished - May 2022

Bibliographical note

Funding Information:
Funding/Support and role of the sponsor: PIONEER is funded through the IMI2 Joint Undertaking and is listed under grant agreement 777492. This joint undertaking receives support from the European Union Horizon 2020 research and innovation programme and EFPIA. The views communicated within are those of PIONEER. Neither the IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein. .

Publisher Copyright:
© 2022 The Authors

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