According to a study conducted by the Patient-Centered Outcomes Research Institute, research studies will be significantly more helpful in clinical decision-making if patients, clinicians and others in the health care community are more involved in developing comparative clinical effectiveness studies.

Results from the study, published in the April 18 issue of JAMA, were presented at a JAMA media briefing at the National Press Club by Anne C. Beal, M.D., M.P.H., of the Patient-Centered Outcomes Research Institute (PCORI), Washington, D.C..

PCORI was created by the Patient Protection and Affordable Care Act of 2010, in order to fund and promote comparative clinical effectiveness research (CER) that will:

“assist patients, clinicians, purchasers, and policymakers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis.”

PCORI developed a definition of patient-centered outcomes research, which highlights the patients’ voices in evaluating health care options.

Dr. Beal explains:

“The PCORI mission statement commits to producing and promoting high-integrity research that is ‘guided by patients, caregivers, and the broader healthcare community.’ The Institute’s first funding announcement solicited projects focused on methods for engaging patients and other stakeholders in all aspects of the research process.”

This announcement has received over 800 responses and a merit review is currently being conducted. The process has been modified in two ways:

  • Stakeholders, including patients, clinicians, and caregivers who were interested in taking part in the merit reviews were invited to sign up via the PCORI website.

  • Proposed scoring criteria included an additional criterion – extent of patient engagement.

Before major funding for research could begin, PCORI was required to develop national priorities for research and a research agenda, and to post both a 45 to 60 day public comment period.

The development process extended from July to December 2011. In addition, the process included assessment of other recent prioritization efforts, as well as suggestions received through discussions with stakeholder groups, including hospital’s and health care systems, clinicians, payers, the life sciences industry, patients and their caregivers and the research community.

The 5 national priorities produced during the process are:

  • Evaluation of options for prevention, diagnosis, and treatment

  • Improving health care systems

  • Dissemination and communications research

  • Addressing disparities

  • Accelerating patient-centered outcomes research and methodology.

The researchers said:

“The national priorities encompass many research areas cited by earlier priority-setting groups, but add a patient-centered perspective.”

For PCORI, transparency is a key principle, say the researchers, and the public comment period included collection of input via an online survey, focus groups carried out across the U.S., as well as a national dialogue event and webcast midway through the comment period.

At present, an examination of this input and resulting revisions to the priorities and agenda are being conducted and announcements regarding the initial funding are expected in May 2012.

The researchers write:

“Applicants will be instructed to explain how their proposed research aligns with the statutory criteria and to describe how patients and other stakeholders will be engaged in and benefit from the research. The initial portfolio of funded research is expected to cover a range of conditions and interventions, to be exemplary of stakeholder-engaged research, and to be highly aligned with the criteria.” The researchers conclude: “The proposition that greater involvement of patients, clinicians, and others in the research process could help reorient the clinical research enterprise, reduce clinical uncertainty, and speed adoption of meaningful findings holds great promise, but remains to be tested.

PCORI will test this hypothesis. The underlying imperative is to improve patients’ care experience, decision making, and health outcomes. Patients as well as the physicians and other health care professionals who care for and about them are invited and encouraged to join in this effort.”

Written By Grace Rattue