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).
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.
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.
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.
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 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.
European urology. 2022 Feb 17 [Epub ahead of print]
Katharina Beyer, Lisa Moris, 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 Williamson, Rakesh 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, PIONEER Consortium
Translational and Oncology Research, Faculty of Life Sciences and Medicine, King's College London, London, UK. Electronic address: ., Department of Urology, University Hospitals Leuven, Leuven, Belgium., Department of Urology, Metropolitan General Hospital, Athens, Greece., Academic Urology Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK., Department of Urology, University Vita e Salute-San Raffaele, Milan, Italy., Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands., Department of Epidemiology, Bayer AG, Berlin, Germany., Cancer Center, University Medical Center Utrecht, Utrecht, The Netherlands., Department of Urology, Hospital de São João, Porto, Portugal; Life and Health Sciences Research Institute, School of Medicine, Minho University, Braga, Portugal., Urology Department, Leon University Hospital, Leon, Spain., Department of Urology, Campus Biomedico, University of Rome, Rome, Italy., International Consortium for Health Outcomes Measurement, Cambridge, MA, USA., Sanofi, Paris, France., COMET Initiative, Department of Health Data Science, University of Liverpool, Liverpool Health Partners, Liverpool, UK., Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle-upon-Tyne, UK., European Association of Urology Guidelines Office, Arnhem, The Netherlands., Department of Urology, University Dresden, Dresden, Germany., Global Medical Affairs Oncology, Bayer Health Care Pharmaceuticals, Whippany, NJ, USA., School of Medicine, Cardiff University, Cardiff, UK., Royal Liverpool and Broadgreen Hospitals NHS Trust, Liverpool, UK., Urology Department, University Jean Monnet, St. Etienne, France., Translational and Oncology Research, Faculty of Life Sciences and Medicine, King's College London, London, UK.