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

Abstract

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

Acknowledgments

We would like to thank the PREFER members of the work package 2.5 who contributed providing their precious insight and expertise: Jorien Veldwijk, Rosanne Janssens, Chiara Jongerius, Isabelle Huys, Richard Hermann, Flavia Faccio, Silvia Pizzoli. We furthermore are deeply grateful to the experts who contributed to the study as either advisory experts or Delphi panel members.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

This research was supported by The Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) project. PREFER has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115966. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. This text and its contents reflects the author’s and PREFER project’s view and not the view of IMI, the European Union or EFPIA.