First draft on patient-centered outcomes research is too broad, lacks focus on clinical effectiveness, says AdvaMed


The Patient-Centered Outcomes Research Institute (PCORI) held a National Patient and Stakeholder Dialogue February 27 as part of its effort to obtain feedback on its first draft National Priorities for Research and initial Research Agenda. The event included public comment as well as two moderated discussion panels of patient and caregiver advocates, clinicians, and other stakeholders.



Chandra Branham, vice president, payment and health care delivery policy at AdvaMed, told PCORI that upon reviewing the draft priorities and research agenda, AdvaMed had three key concerns: too broad, lack of focus on clinical research, and that feedback from stakeholders to the institute must be ongoing.

AdvaMed's three key concerns are as follows:

• First, the scope of the draft National Priorities and Research Agenda is very broad and does not lend itself to meaningful public comment. The draft priorities and research agenda are extremely broad. The five areas identified as priority areas are undoubtedly important areas where comparative clinical effectiveness research could be beneficial to patients and physicians, and AdvaMed understands that PCORI has provided a framework for identifying broad questions that can be addressed through evidence-based research to improve the patient experience of care and enable better, more informed medical decision-making. However, the five areas identified by the PCORI, while important, are so broad that it is difficult to provide detailed comments. Therefore, AdvaMed wants to emphasize the importance of providing additional opportunities for meaningful comments as the research agenda becomes more detailed with respect to specific research. For example, PCORI should include opportunities to provide input when specific research topics are identified in the future, as well as opportunities to comment on preliminary research findings.

• Second, it is essential for PCORI to focus on clinical comparative effectiveness research. AdvaMed supports the use of comparative effectiveness research to inform medical decision making, not to replace medical judgment or interfere with the doctor-patient relationship. The objective of CER should be to provide better evidence for patients and their physicians to use in making individual clinical decisions. Therefore, AdvaMed wants to reiterate that the research the PCORI ultimately funds should be patient-centered clinical effectiveness research – focusing on clinical outcomes, effectiveness, risk and benefits. Such research will ultimately improve quality of care and will have a positive impact on overall improvements and efficiencies in the health care system.

• Finally, PCORI should provide stakeholders the continued opportunity to give meaningful feedback at each stage in the process. AdvaMed greatly appreciates the PCORI's efforts thus far to operate in an open and transparent manner, and to incorporate stakeholder input along the way. AdvaMed has stated in its policies that openness and transparency in all aspects of research, from determining priorities to establishing research methodologies to providing opportunities for meaningful feedback at various stages in the research process will enhance the credibility and strength of the ultimate conclusions of the research. The PCORI has stated previously that the development of its priorities and research agenda will be an ongoing process, with continuous opportunities to refine the documents and to specify potential areas of research.

“AdvaMed looks forward to the continued opportunities to engage in these discussions,” said Branham. “We believe our engagement can be particularly meaningful once PCORI begins to identify specific research areas and topics. The clinical experts who are devoted to developing and manufacturing innovative devices, diagnostics, and other advanced medical technologies have valuable clinical experience and expertise that will enhance the quality of the PCORI research.”

AdvaMed supports PCORI's mission to provide patients, caregivers, and clinicians evidence-based information that can help them make better-informed healthcare decisions.

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