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Developing Patient-Centered Real-World Evidence: Emerging Methods Recommendations From a Consensus Process.

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Summary

This study developed 13 consensus recommendations for incorporating patient experience data (PED) into real-world data (RWD) study design. Applying these guidelines enhances patient-centered real-world evidence (RWE) and research transparency.

Keywords:
patient centeredpatient engagementpatient participationpatient-focused drug developmentreal-world evidence

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Area of Science:

  • Health Services Research
  • Patient-Centered Outcomes Research
  • Real-World Evidence Generation

Background:

  • Patient/stakeholder engagement is recommended for real-world evidence (RWE) but lacks specific guidance for applying patient experience data (PED) in real-world data (RWD) study design.
  • Existing frameworks do not detail how to integrate PED into the methodological steps of RWD studies.

Purpose of the Study:

  • To develop consensus recommendations for researchers on applying PED in the design of RWD studies.
  • To guide the creation of patient-centered RWE by integrating patient perspectives throughout the research process.

Main Methods:

  • A multidisciplinary advisory board guided the development process.
  • Semistructured interviews with 15 RWD researchers explored PED application in study design.
  • An eDelphi survey with 26 participants refined preliminary recommendations into consensus guidelines.

Main Results:

  • Thirteen consensus recommendations were identified for incorporating PED across RWE study design, conduct, and dissemination.
  • Recommendations cover patient-centered research questions, study design elements (e.g., population, comparators), and dissemination strategies.
  • Methods suggest leveraging existing PED and applying insights to various RWD sources, including patient registries.

Conclusions:

  • Implementing these recommendations can enhance the patient centricity and relevance of RWE.
  • Improved integration of PED fosters greater multidisciplinary collaboration and transparency in RWD research.
  • Further refinement of these consensus recommendations may establish best practices for patient-centered RWE.