Abstract
Objectives: A factor contributing to the value of patient preference studies is patient centricity. This study aimed to explore how patients want to be involved in the design and conduct of patient preference studies. In addition, we investigated patients' expectations regarding the communication of study results back to patients.Methods: Semi-structured interviews were conducted with patient representatives within three different disease areas: rheumatic diseases, cancer, and neuromuscular disorders. For each disease area, interviews were conducted with interviewees from Belgium, the Netherlands and the United Kingdom. Interviews followed a predefined interview guide covering topics relating to timing, level, and requirements for patient involvement in patient preference studies, as well as communication of results. Interviews were audio-recorded, transcribed and analyzed using framework analysis in NVivo 12.Results: A total of 14 interviews were conducted. Some interviewees believed that patients should be involved in all steps of a patient preference study. Patient involvement seemed most valuable during the design phase to support defining research questions and instrument design. During analysis, patients can be involved for optimal interpretation of results. Most interviewees mentioned that patient involvement should be on the level of advice or collaboration, not control. Interviewees expressed requirements for patient involvement relating to the knowledge of the involved patient, time investment, compensation and other incentives. Regarding communication of results, most interviewees wished to receive a brief and lay summary of the results, followed by a detailed explanation of both individual and average results accompanied by visuals.Conclusions: Patient involvement in patient preference studies could increase question comprehension by study participants and ensure correct interpretation of results by researchers. Patients want to be involved as advisors or collaborators, and considering their personal situation as well as establishing agreements on roles, time involvement and compensation early on will result in a most optimal partnership.
Highlights
The health care system is undergoing a paradigmatic shift and the role of patients is evolving from being passive recipients to becoming autonomous and actively involved participants (1)
Beyond decisions related to their personal healthcare, patients are increasingly requested to take on active roles in drug development, e.g., provide input in clinical trial design, scientific advice procedures, discussions with regulators and health care policy decision-making at the meso and macro level; referred to as collective patient involvement (3–7)
Than what has been described about patient involvement in clinical trial design, interviewees pointed out the importance of including patients during the interpretation of patient preference study results (6, 24)
Summary
The health care system is undergoing a paradigmatic shift and the role of patients is evolving from being passive recipients to becoming autonomous and actively involved participants (1). Patients are increasingly involved in healthcare decisionmaking at the micro level, referred to as individual patient involvement or shared-decision making (2, 3). Beyond decisions related to their personal healthcare, patients are increasingly requested to take on active roles in drug development, e.g., provide input in clinical trial design, scientific advice procedures, discussions with regulators and health care policy decision-making at the meso and macro level; referred to as collective patient involvement (3–7). The Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) project aims “to strengthen patient-centric decision-making throughout the life cycle of medicinal treatments by developing expert and evidence-based recommendations on how patient preferences should be assessed and inform decisionmaking” (11). The Food and Drug Administration (FDA) recognized this and stated in their guidance on patient preference information (15) that the patient should be “the central focus of the study.”
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
