Seeing Through the Eyes of Patients: The Patient-Centered Outcomes Research Institute Funding Announcements

Abstract

Ideas and Opinions18 September 2012Seeing Through the Eyes of Patients: The Patient-Centered Outcomes Research Institute Funding AnnouncementsFREEHarlan M. Krumholz, MD, SM and Joe V. Selby, MD, MPH, on behalf of the Patient-Centered Outcomes Research InstituteHarlan M. Krumholz, MD, SMFrom Yale University School of Medicine, Yale School of Public Health, Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, and the Patient-Centered Outcomes Research Institute, Washington, DC.Search for more papers by this author and Joe V. Selby, MD, MPHFrom Yale University School of Medicine, Yale School of Public Health, Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, and the Patient-Centered Outcomes Research Institute, Washington, DC.Search for more papers by this author, on behalf of the Patient-Centered Outcomes Research InstituteSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-157-6-201209180-00519 Annals Author Insight Video - Harlan M. Krumholz, MD, SM, and Joe V. Selby, MD, MPH In this video, Harlan M. Krumholz, MD, SM, and Joe V. Selby, MD, MPH, offer additional insight into their original research article, “Seeing Through the Eyes of Patients: The Patient-Centered Outcomes Research Institute Funding Announcements.” SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The introduction of the Patient-Centered Outcomes Research Institute (PCORI) Funding Announcements (PFAs) heralds an era of patient-centeredness in research, promoting science that sees through the eyes of patients. With resources provided through the Patient Protection and Affordable Care Act (ACA), PCORI will invest more than $3 billion between now and 2019 in research that directly addresses questions of relevance to patients, their caregivers, and clinicians. In the process, PCORI aspires to transform applied medical research by more fully integrating the persons who will use the research into the research process.The first round of funding announcements seeks to award $96 million for comparative effectiveness research studies in categories derived from PCORI's National Priorities: assessment of prevention, diagnosis, and treatment options; improvement of health care systems; communication and dissemination of research; and disparity reduction or elimination strategies. Each announcement emphasizes comparisons and outcomes that are meaningful to patients, the examination of possible differences in effectiveness in different patient groups, and an assessment of possibilities and strategies for disseminating and implementing study results.The PFAs are a culmination of the first phase of PCORI's development as a funder of research that will improve health care decision making. Its first tasks were to build an organization, develop a definition for patient-centered outcomes research, identify research priorities, and establish a research agenda. These efforts produced a vision centered on strong advocacy for the role of patients in research and the importance of their perspective in the development of a research program.The language of the PFAs was designed to promote a sense of collaboration that will invite broader participation in the research enterprise. The definition of patient-centered outcomes research developed by PCORI, vetted through public comment and officially approved, contains 4 questions (Table) stated in the first-person voice of a patient. The PFAs incorporate these 4 questions, emphasizing the need for more personalized information on individual risk and the potential benefits and harms of alternative options for individual patients. Implicit in this is the acknowledgment that effectiveness may vary among individuals, as do preferred outcomes, goals, and tolerance for the risks and burdens associated with various options.Table. Questions Identified in the Patient-Centered Outcomes Research Institute's Definition of Patient-Centered Outcomes ResearchThe PFAs address the comparative effectiveness of clinical interventions for prevention, diagnosis, treatment, and monitoring; of personal strategies that patients may adopt to improve their health or to influence the success of medical care; and of strategies that health systems implement to support care delivery, self-care, decision making, and improved outcomes. There is also an interest in strengthening health care delivery to support more effective, more equitable, and safer care.The PFAs are purposely designed as a grassroots effort. They do not specify the conditions, interventions, or questions to be studied. This approach recognizes that there are many important, patient-centered questions that are worthy of attention. Under the 4 broad priorities, PCORI invites applicants to make the case for the relevance of their research questions by using a set of review criteria that emerged from the ACA.Identification of the best proposals relies on the peer-review process, enhanced by the inclusion of patients and other stakeholders. The review criteria emphasize the importance of the condition in terms of population burden and individual suffering, innovations that increase the chances that the proposed research may lead to improved decision making and patient outcomes, the inclusiveness of the study population, the patient-centeredness of the proposal in terms of the comparisons and outcomes being studied, the rigor of the scientific methods, the chance that the research may lead to improved efficiency or performance at the individual or health system level, the composition and quality of the research team, and the efficiency of use of the requested research resources.The PFAs state clearly that patients, as well as other relevant stakeholders, must be included as partners—not merely participants—in the research. Proposals lacking an authentic plan for engaging patients and other relevant stakeholders in the design of the research, as well as in its conduct, and in dissemination and implementation of findings will not be funded. The Institute expects that patients on the team would feel involved in the governance of the project and be able to speak about the aims, design, and importance of the project, having contributed ideas to the effort.To support this orientation, PCORI has recently funded 50 pilot projects (available at www.pcori.org/pilot-projects/) that address various aspects of how patients and stakeholders can be included in the research process. The draft of the PCORI Methodology Committee's report on standards for the conduct of patient-centered outcomes research is also available (www.pcori.org/methodology/). Although applicants are advised that they will not be strictly held to the draft standards during this initial review cycle, they are encouraged to consider relevant standards. Once PCORI revises and adopts the standards, they will be used in the evaluation and scoring of applications. Numerous background papers commissioned for the Methodology Report and addressing specific aspects of patient-centered outcomes research are also posted online and are available for reference.Approaches to engaging patients and other stakeholders will probably vary considerably among projects, depending on the research question and study design. The Patient-Centered Outcomes Research Institute does not assume that these persons have research expertise. Their presence should ensure that the questions are relevant and that the research maintains a focus on benefiting patients as it progresses, leading to results that have a greater chance of being disseminated, implemented, and used. The involvement of patients and stakeholders will be assessed and scored as part of the merit evaluation of each application.The Patient-Centered Outcomes Research Institute seeks to support a new approach to research—one that is inclusive of the perspectives of those whom the research seeks to help. In response to the PFAs, an investigator wrote that the pilot grant program “fundamentally changed the way we think about patient engagement in research, from being passively observed subjects to thinking creatively how to engage them in the design of our research—the way we design the study, how we craft our interventions, and what outcomes we measure.”The Patient-Centered Outcomes Research Institute must ultimately evaluate this new approach by examining whether it leads more consistently to patient and clinician awareness of the evidence, to greater use of the evidence in decision making, and to tangible benefits to patients from the knowledge produced by our support. The challenges are great because the status quo is embedded; involving others takes time and effort. Success will be achieved only if PCORI and the entire community of researchers, patients, and other stakeholders work together to find effective ways to build and sustain strong teams, generate important research questions, and pursue them to create new knowledge. If this occurs, the world may change for the better. Comments0 CommentsSign In to Submit A Comment Bradi B. Granger , RN, PhD, Amy P. Abernethy, MD, Inger Ekman RN, PhD Duke, University of Gothenburg, Sweden. For more information on affiliations see below.16 October 2012 PCORI Language Needs to be Revised to Focus on “Person-Centered” outcomes The purpose of the Patient-Centred Outcomes Research Institute (PCORI) is to assist patients, defined as “any individual with or at risk for a specific health condition”, in making informed decisions about preventing, diagnosing, treating, monitoring and managing disease and illness. PCORI funding was recently summarized in the journal (1). PCORI was based on the Patient Protection and Affordable Care Act (PPACA), which uses both patient-centered and person-centered care as keywords. By acknowledging the person as an independent decision-maker with regard to behavioral changes and health care decisions intended to improve long-term health, PCORI changes the social paradigm around what it means to be not only a patient, but a person. In the recent PCORI report on methodology the concept of “patient-centered” and patient-centricity is used frequently (2,3). In fact, the patient is referenced as a person, someone with opinions, thoughts, wills and wishes, who can also become a patient. Thus, as the intent of PCORI is to address the broader scope of prevention, health maintenance and engagement in life-long self-care, it is critical to define and specify the broader scope of person-centred care into the PCORI language (4). We must move from the concept of health care consumers as “patients” – to engaged individuals with intentions and influence as people – i.e. persons involved in the action at each step along the way. This isn’t simply an exercise in semantics; the language we choose catalyzes a cascade of expectations and relationships. We strongly recommend that the PCORI language is revised to focus on “person-centered” outcomes for the following reasons: 1. In the care spectrum from prevention through chronic illness to palliative care and death, the recipient of care is considered, both by him/herself and by PPACA, as a person and actor in the health care process. The concept of “patient-hood” focuses attention on sickness; we need to focus on the needs of all people, in sickness and in health. 2. Health interventions effect and encompass more than just disease and illness; the use of the term person-centered care, while it relates to health, invites other disciplines such as economists, sociologists and others to participate. 3. The resources from PCORI should flow according to these goals. By limiting the focus to patient-centred care the money flows toward acute care settings and clinical trials. By extending to personhood, the scope of research and innovation is broadened towards the 5000 hours spent outside the healthcare setting (5). Bradi B. Granger, RN, PhD, Director, Duke Heart Center Nursing Research ProgramAssociate Director, Duke Translational Nursing InstituteAssociate Professor, Duke University School of Nursing Amy P. Abernethy, MD, Director Center for Learning Health Care, Duke Clinical Research InstituteDirector Duke Cancer Care Research Program, Duke Cancer Institute Associate Professor, Division of Medical Oncology, Department of Medicine Duke University School of Medicine Inger Ekman RN, PhD, Institute of Health and Care Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Person-Centred Care (GPCC) University of Gothenburg, Gothenburg, Sweden, www.gpcc.gu.se