How Patient-Centered Outcomes Research is Connected to HIV Nursing

Patient-Centered Outcomes Research: Early Evidence From A Burgeoning Field.

Novel record linkage (RL) methods have the potential to enhance clinical informatics by integrating patient data from multiple sources-including electronic health records, insurance claims, and digital health devices-to inform patient-centered care. Engaging patients and other stakeholders in the use of RL methods in patient-centered outcomes research (PCOR) is a key step in ensuring RL methods are viewed as acceptable, appropriate, and useful. The University of Colorado Record Linkage (CURL) platform empowers the use of RL in PCOR. This study aimed to describe the process of engaging patients and other stakeholders in the design of an RL dissemination package to support the use of RL methods in PCOR. Customer discovery, value proposition design, and user experience methods were used to iteratively develop an RL dissemination package that includes animated explainer videos for patients and an RL research planning workbook for researchers. Patients and other stakeholders (researchers, data managers, and regulatory officials) were engaged in the RL dissemination package design. Patient partners emphasized the importance of conveying how RL methods may benefit patients and the rules researchers must follow to protect the privacy and security of patient data. Other stakeholders described accuracy, flexibility, efficiency, and data security compared with other available RL solutions. Dissemination package communication products reflect the value propositions identified by key stakeholders. As prioritized by patients, the animated explainer videos emphasize the data privacy and security processes and procedures employed when performing research using RL. The RL workbook addresses researchers' and data managers' needs to iteratively design RL projects and provides accompanying resources to alleviate leadership and regulatory officials' concerns about data regulation compliance. Dissemination products to promote adoption and use of CURL include materials to facilitate patient engagement in RL research and investigator step-by-step decision-making materials about the integration of RL methods in PCOR.

The engagement of patients and other stakeholders is a critical element in the design of patient-centered outcomes research studies. However, methodology for scalable engagement in research management particularly activities such as operationalization of principles and setting of priorities is not well-developed. The objective of this study is to describe a novel approach for scalable stakeholder engagement in research aligned with the Patient-Centered Outcomes Research Institute (PCORI) engagement principles, which was evaluated in a national clinical data research network. Patient, patient advocate, clinician, and researcher stakeholders were recruited from clinical sites, as well as social media sites related to the 3 conditions of focus, heart failure, obesity, and Kawasaki disease. The engagement strategy was designed, implemented, and mapped to the PCORI engagement principles. Evaluation included internal assessment and quantitative measures of online engagement. We operationalized the PCORI principles with 12 stakeholder engagement strategies and convened stakeholder advisory boards and online research prioritization panels to determine research priorities in a rigorous, deliberative process. A total of 46 advisors (20 patients) and 339 panelists (159 patients) actively participated. There were not significant differences between patients and clinicians in level of online engagement. Nonetheless, while patients reported a slightly greater challenge with following online discussion, they overall had a more favorable opinion about use of the online format. An efficient way to engage large numbers of representative stakeholders in research is a necessary first step to assure the public of trustworthy use of data networks for health research. This paper describes a comprehensive approach to engagement in patient-centered outcomes research management that informs ongoing development of rigorous methodologies in this area.

Rigorous methodological standards help to ensure that medical research produces information that is valid and generalizable, and are essential in patient-centered outcomes research (PCOR). Patient-centeredness refers to the extent to which the preferences, decision-making needs, and characteristics of patients are addressed, and is the key characteristic differentiating PCOR from comparative effectiveness research. The Patient Protection and Affordable Care Act signed into law in 2010 created the Patient-Centered Outcomes Research Institute (PCORI), which includes an independent, federally appointed Methodology Committee. The Methodology Committee is charged to develop methodological standards for PCOR. The 4 general areas identified by the committee in which standards will be developed are (1) prioritizing research questions, (2) using appropriate study designs and analyses, (3) incorporating patient perspectives throughout the research continuum, and (4) fostering efficient dissemination and implementation of results. A Congressionally mandated PCORI methodology report (to be issued in its first iteration in May 2012) will begin to provide standards in each of these areas, and will inform future PCORI funding announcements and review criteria. The work of the Methodology Committee is intended to enable generation of information that is relevant and trustworthy for patients, and to enable decisions that improve patient-centered outcomes.

Development of National Research and Clinical Agendas for Patient-Reported Outcomes in IR: Proceedings from a Multidisciplinary Consensus Panel

Download a PDF of "Accelerating the Use of Findings from Patient-Centered Outcomes Research in Clinical Practice to Improve Health and Health Care" by the National Academies of Sciences, Engineering, and Medicine for free.

Patient-centered outcomes research (PCOR) emphasizes the involvement of patients and other interested stakeholders during study design, implementation, and evaluation. We provide an example of PCOR using “research democracy”—a process in which individuals involved in research (e.g., team members, participants, and advisors) have a vote and a voice in the decisions that are made and the procedures that are used to conduct the research. We describe the Nueva Vida Intervention study and the strategies used to strengthen team management and team cohesion and to utilize team diversity as an asset. We collected data on team engagement through informal observations, direct discussions, and survey assessments. Team members overwhelmingly agreed that using research democracy approaches increased mutual trust and an individual’s level of influence during the study. Identified barriers indicated the importance of effective communication and the challenges with recruitment, while the benefits included a heightened sense of collaboration and a better understanding of the research process. Initial results suggest that team engagement and research democracy approaches are advantageous to conducting an efficient and effective study, thereby improving PCOR and ultimately benefiting the patients and their caregivers.

Improved health outcomes and lower costs have been reported with pharmacist-led patient-centered approaches to medication optimization in older adults, but heterogeneity in studies has complicated assessments of how well these approaches have worked. Among the challenges in advancing care from patient-centered research is uncertainty in how well research questions have matched patients' care needs. One strategy is to engage patients, ideally as equal partners, in the preparation, execution, and dissemination of research. The objective of this study was to survey older adults, caregivers, researchers, and pharmacists to better understand the needs for training on patient-centered outcomes research (PCOR) focusing on medication optimization in older adults. A 12-member Community Council was formed to guide the project and to build capacity for engaging older adults, caregivers, researchers, and pharmacists in medication-related patient-centered outcomes research. The Community Council consisted of individuals from three regions: Hawaii, Midwest, and Mid-Atlantic. The Council created a needs assessment survey that was deployed electronically. There were 93 Elder Care Network participants who were asked to complete the needs assessment survey and 74 surveys were received resulting in a response rate of 80% but only 68 were completed and included in the analysis. Explaining what PCOR is, sharing examples of how members of the community can participate in research, discussing how community members can work with research teams to answer questions, and helping respondents understand how research can affect them were the top responses. Work of the Elder Care Medicine Network illustrates the importance of understanding the ongoing needs for education that are customized to meet the needs and preferences reported by older adults, caregivers, compared to clinicians and researchers.

Addressing Urologic Health Disparities in Sexual and Gender Minority Communities Through Patient-Centered Outcomes Research

The 2015 NAPCRG Pratice-Based Research Network (PBRN) Conference brought together the energy of 232 participants (a new record!) with patients, clinicians, researchers, and PBRN teams networking in Bethesda, Maryland from June 29–30. Conference co-chairs, Rowena Dolor and LJ Fagnan provided the

The Association of Departments of Family Medicine (ADFM) recently responded to the Patient Centered Outcomes Research Institute’s (PCORI) Request for Information on how best to build research infrastructure for patient centered outcomes research (PCOR). We proposed the establishment of a national

When the USA was debating healthcare reform and negotiating how to provide the best quality care for the lowest cost to all Americans, some looked to the UK’s NICE, and thought that developing a similar organization might be a good idea. Americans were hesitant, however, to copy the British model due to fears that comparative effect iveness research (CER) would lock the US healthcare system into a ‘one-size-fits-all’ paradigm and restrict patient access to new treatments that may benefit many patients. By design, the Patient Centered Outcomes Research Institute (PCORI) put in place by America’s Affordable Care Act, included language intended to align CER with personalized medicine. Still a young organization, PCORI has already chosen an Executive Director, seated both its Board of Governors and its Methodology Committee, hired a few key staff, and asked the public for feedback on its definition of Patient Centered Outcomes Research, Draft Translation Framework Components, and Draft National Priorities for Research and Research Agenda. While PCORI has laid a foundation, thus far, its broad and vague research priorities leave the personalized medicine community uncertain about whether that foundation will support the continued development of personalized medicine. Amy Miller, Personalized Medicine Coalition’s (PMC’s) Vice President for Public Policy, noted in a letter the PMC sent to the Institute: “Broad drafting does not allow for an examination of individual research proposals, topics or research questions; thus, it is not possible to say whether PCORI’s work will support personalized medicine or not.” The challenges ahead for PCORI, however, do not stop with the drafting of specific research priorities. The Institute must also create an infrastructure that supports its mandate to align personalized medicine and CER. Congress required procedures to assure that alignment. But thus far the Institute has not fully developed the internal structure or expertise necessary to develop calls for research proposals, evaluate them, make awards, and do so through an open, transparent and focused process. In the PMC’s letter to the Institute, the coalition offered five recommendations about how PCORI could better define its research agenda and build the infrastructure needed to execute its mission as congress intended.

Develop an accessible exercise to engage underserved populations about research funding priorities; analyze the criteria they use to prioritize research; contrast these criteria to those currently used by Patient Centered Outcomes Research Institute (PCORI). Academic and community partners collaborated to develop an Ipad exercise to facilitate group deliberation about PCOR funding priorities. 16 groups (n = 183) of underserved individuals in both urban and rural areas participated. Recordings were qualitatively analyzed for prioritization criteria. Analysis yielded ten codes, many of which were similar to PCORI criteria, but all of which challenged or illuminated these criteria. Directly involving underserved populations in determining funding criteria is both feasible and important, and can better fulfill PCORI's goal of incorporating patient priorities.

Comparative effectiveness of next generation genomic sequencing for disease diagnosis: Design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes

Objectives:Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation.Methods:At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings.Results:Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment.Conclusions:Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction.