Integrating the Patient Perspective Into Research Design in the US: Case Studies and Recommendations

Clinical research-its methodologies, approaches, rigor, review processes, and results dissemination mechanisms-has resulted in tremendous benefits to both individuals and populations throughout its history in the US. Patients have traditionally played a subservient role in medical care-more or less willingly and by design-relying on an elite corps of educated experts to recommend and implement decisions. However, as the field of medicine advances into the 21st century, patients are called upon to make more, and more sophisticated, healthcare decisions with both financial and personal ramifications. As this trend has accelerated, it has become clear that the current state of clinical research has proven inadequate to serve the informational needs of this constituency, and new approaches have been proposed and tested, including those using uniquely 21st century tools, such as social media and ubiquitous technology. While many of these efforts remain in their infancy, a review of several case studies can serve to illuminate trends and results, and enable recommendations and conclusions that can assist in the future of patient-centered research. From this analysis, several major themes become apparent. First, the best patient-centered research directly assessed patient involvement using both qualitative and quantitative measures. Second, engagement between patients and a variety of stakeholders in the research definition process created synergies and insights that would not otherwise have revealed themselves, including a virtuous cycle that increased patient interest and involvement in general. Third, creating a systemic platform for on-going patient engagement can have long-lasting value through fundamental changes to the culture of research prioritization and design. These foundational benefits occur independently of the timing, nature and method of harnessing patient feedback, as well as the quantity of that feedback. Patient-centered research, however, is still research and, as such, should function within the time-tested framework (ethical and otherwise) for conducting research. However, the evidentiary objectives of that research need to incorporate patient input in order to create a level playing field, and a common language, for the doctor-patient relationship. Research that addresses these themes will enable patients to more readily participate in today's healthcare system. Systemic participation will, moreover, provide value to the patient through collaboration with other stakeholders to identify optimal individualized care plans, make better informed decisions, and ultimately improve outcomes-all through focusing on the practicalities of the patient's life and treatment journey.Master of Public Healt