Since the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), AHRQ, an agency within the Department of Health and Human Services (HHS), has been one of several federal agencies responsible for supporting and disseminating the results of CER. The dissemination of CER refers to developing and distributing information derived from CER for target audiences, such as clinicians, consumers, or policymakers, in order to inform health care delivery or practice. This process involves translating research findings into terminology and materials that are appropriate for the target audience. Specifically, AHRQ has supported CER activities by awarding grants and contracts to research centers and academic organizations to carry out this work, which includes reviewing and synthesizing scientific evidence through research reviews; generating new scientific evidence and analytical tools in original research reports; compiling research findings; and communicating those findings to a variety of audiences. Under the American Recovery and Reinvestment Act of 2009 (Recovery Act), AHRQ received funding of $474 million to support and disseminate the results of CER—$300 million that was appropriated to AHRQ and $174 million that was appropriated to the HHS Office of the Secretary and allocated to AHRQ. The Recovery Act also required the Secretary of HHS to enter into a contract with the IOM to produce a report that included recommendations on research questions that should receive national priority for study with CER funds made available under the act. The result of this work included a list of 100 research questions prioritized for CER. In 2010, PPACA authorized the establishment of PCORI as a nonprofit corporation aimed at advancing the quality and relevance of evidence through CER to help patients, clinicians, purchasers, and policy-makers in making informed health care decisions. The law requires PCORI to perform a number of duties related to CER. (See table 1.) PCORI is governed by a 21-member Board of Governors and employs 153 staff, as of September 2014, including directors for its different program areas as well as staff for engagement, communications, contract management, finance, human resources, and information technology. PCORI’s 17-member methodology committee defines methodological standards for its research. PCORI has developed five broad research priorities and developed a research agenda to identify how each priority will be addressed. The institute has established a multi-step merit review process to score and identify applications for funding and a process for monitoring contractors. PCORI is also developing a peer review process for primary research and a dissemination plan for completed research. In 2012, PCORI established five broad research priorities: (1) assessment of prevention, diagnosis, and treatment options; (2) improving health care systems; (3) communication and dissemination research; (4) addressing disparities; and (5) accelerating patient-centered outcomes research and methodological research. PCORI also developed a research agenda to identify how each priority would be addressed. The research agenda contains a set of more specific research areas within each priority. PCORI expects its research agenda to be updated and refined over time based on more specific analyses of gaps in research. (See table 2.) PCORI issued its research priorities and agenda in May 2012, following a process that began in July 2011. In the fall of 2011, PCORI formed two workgroups within its Board of Governors—the National Priorities for Research Workgroup and the Research Agenda Workgroup. Along with PCORI staff and members of the Methodology Committee, these workgroups examined the processes and products of other recent priority- and agenda-setting efforts, including those from AHRQ and IOM. They also engaged with and received input from stakeholder groups through a number of public presentations and other modes of communication, such as press releases, focus groups, and feedback through social media. PCORI posted on its website its draft research priorities and agenda for public comment from January 23, 2012 to March 15, 2012. In response, PCORI received and analyzed a total of 474 formal comments, and made changes to the draft priorities and agenda based on these comments. A final version of PCORI’s research priorities and agenda were adopted by the Board of Governors and made publicly available in May 2012. PCORI established its research priorities and agenda consistent with PPACA requirements. Specifically, PPACA directed PCORI to establish priorities for research that take into account factors that include disease incidence, prevalence, and burden; gaps in evidence with regard to clinical outcomes; patient needs, outcomes, and preferences; and practice variations and health disparities in terms of delivery and outcomes of care, among other things. The act also directed PCORI to develop a research agenda for addressing these priorities. The act did not specify the content or form of the priorities or agenda. According to documentation on the process PCORI used to develop its research priorities and agenda, the workgroups reviewed and considered these requirements. In the process of developing the research agenda, the workgroups identified where, for example, certain agenda items addressed criteria such as gaps in knowledge, variation in care, and inclusiveness of different populations. According to PCORI officials, PCORI intended its research priorities to be broad in scope so that they could encompass a broad range of topics in need of study, including different disease areas, conditions, or health care system issues, thus making PCORI’s research agenda more flexible than if it identified specific topics. PCORI noted in its research priorities and agenda document that PCORI did not want to exclude any disease from being studied. Some stakeholders we interviewed expressed concern that PCORI’s research priorities are too broad and lack specificity. While PCORI officials acknowledged that many of the institute’s initial funding announcements were broad in that they did not identify specific topics, they noted that they are in the process of increasing the proportion of funding that goes to specific research topics. For example, PCORI will soon begin funding awards for large pragmatic clinical studies to evaluate patient-centered outcomes. The funding announcement for this effort indicates a number of specific research topics of interest to PCORI. PCORI officials noted that applications which are responsive to these specific research topics will be given priority for funding. The specific research topics identified in this funding announcement were developed using, among other things, stakeholder recommendations, IOM’s CER Priorities, and input from PCORI’s advisory panels. To identify more specific research questions and topics for use in funding announcements, PCORI utilizes advisory panels, as authorized by PPACA. PPACA directed PCORI to establish advisory panels for rare diseases and clinical trials, which PCORI established in November 2013, and also authorized PCORI to establish other advisory panels as needed. In addition to establishing the two advisory panels required by PPACA, PCORI has also established five additional advisory panels: (1) Assessment of Prevention, Diagnosis, and Treatment Options; (2) Improving Healthcare Systems; (3) Addressing Disparities; (4) Patient Engagement; and (5) Communication and Dissemination Research. Four of these advisory panels align with PCORI’s research priorities. To appoint members to its advisory panels, PCORI solicits applications via its website. Advisory panel applicants are reviewed based on common criteria established by PCORI and against the needs of the specific panel for which a position is being filled. The PCORI Board of Governors makes the final selection of advisory panel members. PCORI’s advisory panels assist in the prioritization of research topics. PCORI receives suggested research topics through a number of sources, including stakeholders, social media, and workshops, as well as from AHRQ, NIH, and professional and advocacy groups. As part of the prioritization process, PCORI’s advisory panels evaluate and rank suggested research topics using the following criteria: patient- centeredness, potential condition impact, assessment of current options, likelihood of implementation in practice, and durability of information. Topics identified by advisory panels as being of higher priority proceed for further evaluation while the lower-priority topics enter a pool of topics that may be reconsidered at a later date. Recommendations from PCORI’s advisory panels are taken into consideration by PCORI’s staff and Board of Governors and are used to refine and prioritize specific research topics and inform the development of PCORI funding announcements. PCORI may also use recommendations from advisory panels to commission reviews of previous and current research on recommended high-priority topics. According to PCORI, its processes for identifying research include mechanisms for avoiding unnecessary duplication and coordinating research efforts with NIH and AHRQ. For example, when establishing its broad research priorities, officials from both NIH and AHRQ participated in PCORI’s workgroups to develop these priorities and the related research agenda. As PCORI has developed more specific research priorities for funding announcements, PCORI staff has consulted with relevant NIH staff on specific topics in an effort to obtain expertise and an understanding of what research is being funded on a particular topic. For example, PCORI officials reported and NIH confirmed that when developing a specific research topic related to cardiovascular disease, PCORI coordinated with staff at NIH’s National Heart, Lung, and Blood Institute to ensure that PCORI’s planned research in this area had not already been sufficiently addressed by prior research. NIH submitted to PCORI a list of potential topics it considered important but was not actively funding, according to PCORI officials. PCORI officials also stated that when a new topic is suggested to PCORI for inclusion in a funding announcement, technical briefs are prepared to document the existing work that has been completed on that topic.