Building sustainable multi-functional prospective electronic clinical data systems.

A better alignment in the goals of the biomedical research enterprise and the health care delivery system can help fill the large gaps in our knowledge of the impact of clinical interventions on patient outcomes in the real world. There are several initiatives underway to align the research priorities of patients, providers, researchers, and policy makers. These include Agency for Healthcare Research and Quality (AHRQ)-supported projects to build flexible prospective clinical electronic data infrastructure that meet the needs of these diverse users. AHRQ has previously supported the creation of 2 distributed research networks as a new approach to conduct comparative effectiveness research (CER) while protecting a patient's confidential information and the proprietary needs of a clinical organization. It has applied its experience in building these networks in directing the American Recovery and Reinvestment Act funds for CER to support new clinical electronic infrastructure projects that can be used for several purposes including CER, quality improvement, clinical decision support, and disease surveillance. In addition, AHRQ has funded a new Electronic Data Methods forum to advance the methods in clinical informatics, research analytics, and governance by actively engaging investigators from the American Recovery and Reinvestment Act-funded projects and external stakeholders.

Primary Care Research in the Patient-Centered Outcomes Research Institute's Portfolio.

In their article in this issue, Mazur and colleagues analyze the characteristics of early recipients of funding from the Patient-Centered Outcomes Research Institute (PCORI). Mazur and colleagues note correctly that PCORI has a unique purpose and mission and suggest that it should therefore have a distinct portfolio of researchers and departments when compared with other funders such as the National Institutes of Health (NIH). Responding on behalf of PCORI, the authors of this Commentary agree with the characterization of PCORI's mission as distinct from that of NIH and others. They agree too that data found on PCORI's Web site demonstrate that PCORI's portfolio of researchers and departments is more diverse and more heavily populated with clinician researchers, as would be expected. The authors take issue with Mazur and colleagues' suggestion that because half of clinical visits occur within primary care settings, half of PCORI's funded research should be based in primary care departments. PCORI's portfolio reflects what patients and others tell PCORI are the critical questions. Many of these do, in fact, occur with more complex conditions in specialty care. The authors question whether the research of primary care departments is too narrowly focused and whether it sufficiently considers study of these complex conditions. Research on more complex conditions including heart failure, coronary artery disease, and multiple comorbid conditions could be highly valuable when approached from the primary care perspective, where many of the comparative effectiveness questions first arise.

How the Patient-Centered Outcomes Research Institute is engaging patients and others in shaping its research agenda.

Clinical research has been driven traditionally by investigators, from generating research questions and outcomes through analysis and release of study results. Building on the work of others, the Patient-Centered Outcomes Research Institute (PCORI) is tapping into its broad-based stakeholder community--especially patients, caregivers, and their clinicians--to generate topics for research, help the institute prioritize those topics, select topics for funding, and ensure patients' involvement in the design of research projects. This article describes PCORI's approach, which is emblematic of the organization's mandate under the Affordable Care Act to seek meaningful ways to integrate the patient's voice into the research process, and describes how it is being used in selection of research that PCORI will fund. We also describe challenges facing our approach, including a lack of common language and training on the part of patients and resistance on the part of researchers to questions that are not researcher generated. Faced with the reality that PCORI will not be able to fund all research questions posed to it, there will also be difficult decisions to make when selecting those that have the highest priority for funding.

Comparative effectiveness research priorities at federal agencies: the view from the Department of Veterans Affairs, National Institute on Aging, and Agency for Healthcare Research and Quality.

In the last year, attention has been focused on translating federally sponsored health research into better health for Americans. Since the passage of the American Recovery and Reinvestment Act (ARRA) on February 17, 2009, ARRA funds to support Comparative Effectiveness Research (CER) have increased this focus. A large proportion of topical areas of interest in CER affects the older segment of the population. The Department of Veterans Affairs (VA), the National Institute on Aging (NIA), and the Agency for Healthcare Research and Quality (AHRQ) have supported robust research portfolios focused on aging populations that meet the varying definitions of CER. This short article briefly describes the research missions of the AHRQ, NIA, and VA. The various definitions of CER as the Congressional Budget Office, the Institute of Medicine, and the ARRA-established Federal Coordinating Council have put forward, as well as important topics for which CER is particularly needed, are then reviewed. Finally, approaches in which the three agencies support CER involving the aging population are set forth and opportunities for future CER research outlined.

Moving closer to a rapid-learning health care system.

This Perspective discusses activities that are necessary for developing a rapid-learning health system. Recognition of the central role that patients play in the successful evolution of such a system will help ensure that the goals of the transformation are met. Understanding the trade-offs of using a less controlled form of research to inform health care decision making and making necessary investments in methodology and translation will help secure the success of continuous-learning research. Major public policy interest in promoting health information technology and in getting more value for health care spending creates a framework for moving ahead.

Clinicians' attitudes to clinical practice guidelines: a systematic review.

OBJECTIVE: To systematically review surveys of clinicians' attitudes to clinical practice guidelines. DATA SOURCES: MEDLINE, HealthStar, Embase and CINAHL were searched electronically for English-only surveys published from 1990 to 2000. STUDY SELECTION: We included surveys with responses to one or more of seven propositions (see below). Studies were excluded if they had fewer than 100 respondents or if the response rate was less than 60%. RESULTS: Thirty studies included responses to one or more of the seven items, giving a total of 11 611 responses. The response rate for the included studies was 72% (95% confidence interval [CI], 69%-75%). Clinicians agreed that guidelines were helpful sources of advice (weighted mean, 75%; 66%-83%), good educational tools (71%; 63%-79%) and intended to improve quality (70%; 60%-80%). However, clinicians also considered guidelines impractical and too rigid to apply to individual patients (30%; 23%-36%), that they reduced physician autonomy and oversimplified medicine (34%; 22%-47%), would increase litigation (41%; 32%-49%) and were intended to cut healthcare costs (52.8%; 39%-66%). CONCLUSIONS: Surveys of healthcare providers consistently report high satisfaction with clinical practice guidelines and a belief that they will improve quality, but there are concerns about the practicality of guidelines, their role in cost-cutting and their potential for increasing litigation.