Updating and integrating core outcome sets for localised, locally advanced, metastatic and non-metastatic castration resistant prostate cancer: an update from the PIONEER Consortium

Katharina Beyer* (Corresponding Author), Lisa Moris, Michael Lardas, Muhammad Imran Omar, Jemma Healey, Sheela Tripatheed, Giorgio Gandaglia, Lionne DF Venderbos, Eleni Vradi, Thomas van den Broeck, Peter-Paul M. Willemse, Tiago Antunes-Lopes, Luís Pacheco-Figueiredo, Serenella Monagas Arteaga, Francesco Esperto, Stephen Flaherty, Zsuzsanna Devecseri, Thomas Lam, Paula R. Williamson, Rakesh HeerEmma Jane Smith, Alex Asiimwe, Johannes Huber, Monique J Roobol, Jihong Zong, Malcolm D. Mason, Philip Cornford, Nicolas Mottet, Sara MacLennan, James N'Dow, Alberto Brigantii, Steven MacLennan, Mieke Van Hemelrijck, PIONEER Consortium

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Context: Harmonising outcome reporting and definitions in clinical trials and in routine patient records can enable healthcare systems to provide more efficient outcome-driven and patient centred interventions. We report on the work of the IMI Big Data Consortium Prostate Cancer Diagnosis and Treatment Enhancement Through the Power of Big Data in Europe (PIONEER).

Objective: To update and integrate existing prostate cancer (PCa) Core Outcome Set (COS) for the different stages of PCa, while also assessing their applicability and developing standardised definitions of prioritised outcomes.

Evidence acquisition: We followed a four-stage process:(1) systematic reviews;(2)
qualitative interviews;(3) expert group meetings to agree standardised terminologies;(4) recommendations for 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 a) localised and locally advanced, and b) metastatic and non-metastatic castration resistant PCa COS. No new outcomes were identified in our COS for localised/locally advanced PCa. For our metastatic and non-metastatic CRPC COS, nine new core outcomes were identified.

Conclusion: These are the first COS in PCa where the definitions of the prioritised outcomes have been surveyed in a systematic, transparent, and replicable way. Furthermore, this is the first-time recommendations for outcome definitions across all prostate cancer COS have been agreed on by a muldisciplinary expert group and recommended for use in research and clinical
practice settings (see Table 4,5). To limit heterogeneity across research, they should be recommended for future effectiveness trials, systematic reviews, guidelines and clinical practice of localised and metastatic PCa.

Patient summary: PCa patient outcomes after treatment are difficult to compare due to variability. To enable better use of PCa patient data, PIONEER standardised and recommended outcomes (and their definitions) that should be collected as a minimum in all future studies.
Original languageEnglish
JournalEuropean Urology
Publication statusAccepted/In press - 20 Jan 2022

Keywords

  • Prostate Cancer
  • Patient pathway
  • Comparative effectiveness research
  • Core outcome sets
  • Standardised outcome sets
  • Outcomes
  • Randomized controlled trials
  • Systematic reviews
  • Big Data
  • Real world Data

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