Mixed-methods approach to develop an agreed concept on patient relevance: study protocol for the 'PRO patients study'

Area of Science:

• Health Services Research
• Patient-Reported Outcomes
• Shared Decision-Making

Background:

• Measuring patient-relevant outcomes is crucial for patient-centered care and shared decision-making.
• A recent scoping review highlighted a lack of clear definitions and consistent sets of patient-relevant outcomes.
• There is a need for a standardized concept of patient relevance and a universally applicable set of outcomes.

Purpose of the Study:

• To develop an agreed-upon concept of patient relevance.
• To establish a set of patient-relevant outcomes applicable across diseases.
• To grade outcomes by importance to inform clinical research and patient care.

Main Methods:

• A prospective mixed-methods study integrating patient, healthcare professional, and researcher perspectives.
• Phased approach including a patient survey, multiprofessional group discussions, and a two-round online Delphi method.
• Utilizes findings from a prior scoping review to inform the patient survey.

Main Results:

• The study aims to achieve consensus on a definition of patient relevance.
• A graded set of patient-relevant outcomes will be developed.
• The process will inform methods for individualizing clinical trial outcomes.

Conclusions:

• An agreed concept of patient relevance will enhance the comparability of study results on patient benefit.
• Implementation will strengthen the role of patients in healthcare decision-making.
• Findings will facilitate individualized clinical trial outcomes, better representing the patient perspective.