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RESEARCH PRODUCT

Taking into Account Patient Preferences: A Consensus Study on the Assessment of Psychological Dimensions Within Patient Preference Studies

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Selena Russo,1,2,* Dario Monzani,3,4,* Cathy Anne Pinto,5 Laura Vergani,3,4 Giulia Marton,3,4 Marie Falahee,6 Gwenda Simons,6 Chiara Whichello,7 Ulrik Kihlbom,8,* Gabriella Pravettoni3,4,* 1Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy; 2Discipline of Paediatrics, School of Women’s and Children’s Health, The University of New South Wales, Kensington, NSW, Australia; 3Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy; 4Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy; 5Department of Pharmacoepidemiology, Merck & Co., Inc., Kenilworth, NJ, USA; 6Rheumatology Research Group, Institute of Inflammation and Ageing (IIA), University of Birmingham, Birmingham, UK; 7Erasmus School of Health Policy & Management (ESHPM) and Erasmus Choice Modelling Centre (ECMC), Erasmus University Rotterdam, Rotterdam, The Netherlands; 8Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden*These authors contributed equally to this workCorrespondence: Selena RussoDepartment of Medicine and Surgery, University of Milano, Bicocca, via Cadore 48, Monza (MB), 20052, ItalyEmail selena.russo@unimib.itAbstract: Patient preferences are gaining recognition among key stakeholders involved in benefit-risk decision-making along the medical product lifecycle. However, one of the main challenges of integrating patient preferences in benefit-risk decision-making is understanding differences in patient preference, which may be attributable to clinical characteristics (eg age, medical history) or psychosocial factors. Measuring the latter may provide valuable information to decision-makers but there is limited guidance regarding which psychological dimensions may influence patient preferences and which psychological instruments should be considered for inclusion in patient preference studies. This paper aims to provide such guidance by advancing evidence and consensus-based recommendations and considerations. Findings of a recent systematic review on psychological constructs having an impact on patients’ preferences and health-related decisions were expanded with input from an expert group (n = 11). These data were then used as the basis for final recommendations developed through two rounds of formal evaluation via an online Delphi consensus process involving international experts in the field of psychology, medical decision-making, and risk communication (n = 27). Three classes of recommendations emerged. Eleven psychological constructs reached consensus to be recommended for inclusion with the strongest consensus existing for health literacy, numeracy, illness perception and treatment-related beliefs. We also proposed a set of descriptive and checklist criteria to appraise available psychological measures to assist researchers and other stakeholders in including psychological assessment when planning patient preference studies. These recommendations can guide researchers and other stakeholders when designing and interpreting patient preference studies with a potential high impact in clinical practice and medical product benefit-risk decision-making processes.Keywords: patient preferences, patients reported outcomes, psychological assessment, decision-making