Published by Oxford University Press.
Editorial |
Practice-based primary care research—translating research into practice through advanced technology
Family Medicine and Community Health, University of Minnesota, MN, USA; Email: peter223{at}umn.edu
Peterson K. Practice-based primary care research—translating research into practice through advanced technology. Family Practice 2006; 23: 149–150.
In order for scientific discoveries to improve human health, they must be moved from the laboratory bench and be incorporated into practical applications in the community.1 This ‘translation’ of research into practice is a two-way street. Not only do basic scientists deliver to clinicians new tools to examine patients, but also clinical researchers make novel observations about the nature and progression of disease that can stimulate basic scientific investigations in the laboratory. It is the appropriate role of the clinical investigator to help span this chasm from bench to bedside and from bedside to community; to promote the translation of biomedical research findings into clinical use; to generate new knowledge from clinical inquiry and to integrate evidence-based knowledge into the practices of community providers.
In recent years the rapid expansion of knowledge and an explosion of medical literature have strained the ability of clinicians to keep up to date with the latest recommendations. It has been estimated to take up to 17 years to integrate only 30% of clinical recommendations.2 The isolation of primary care from the academic health center, the usual site for clinical research, appears to further aggravate the delay between the discovery of new research findings and the adoption of those findings into practice.
The majority of research over the last 50 years has been focused on discovering new treatments, and moving that new information from the bench to bedside, the first phase of translation (Fig. 1). The result is a disequilibrium between Phase 1 and Phase 2 translation where in the United States ‘for every dollar Congress allocates to develop breakthrough treatments, it allocates one penny to ensure that Americans actually receive them.’3 In order to ensure that clinical research rapidly and successfully advances practice, clinical researchers need to develop new partnerships with primary care providers who deliver the majority of care to the population. These partnerships should enhance the ability of investigators to conduct research, as well as facilitate delivery of better tools to clinicians to provide care. There is in Europe a growing base of epidemiological research conducted using the routine electronic health records of family physicians.4,5
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As more information becomes available at a faster pace, greater reliance is placed on evidence-based data to inform practice. Randomized controlled trials (RCTs) form the foundation of this evidence base. The true effectiveness of an innovation can only be judged in appropriately designed clinical trials conducted in the setting where the innovation will be applied. However, RCTs have only recently been performed in primary care practices for many reasons. Practices are not able to identify eligible individuals for a trial, and privacy standards severely restrict research access to private health information. Patients selected from clinics are often clustered by physician or by practice demographics, complicating analysis and compromising generalizability.6
Over the last 15 years in the UK, and more recently in the United States, a body of work in ‘pragmatic’ clinical trials has evolved that typically addresses questions of ‘effectiveness’ rather than efficacy. However, the need to involve large numbers of practitioners and their staff, up to several hundreds, in recruitment to a trial has led to significant practical difficulties and some trials have failed to recruit adequately.4 In parallel, in the recent years there has been increased pressure on academic centers. Changes in the health care system, including the growth of managed care, have altered the demographics of academic center patient populations, and hampered the accrual, delivery of standard protocols, and tracking of subjects.
Emerging technologies and methodologies now promise to overcome these obstacles. Introduction of open-source technology using very high-speed backbone networking allows greater functionality, security, and communication, and permits the integration of primary providers and their practice populations into the clinical research enterprise in ways that were never possible before. The electronic infrastructure for the electronic Primary Care Research Network (ePCRN), a new pilot study funded by the National Institutes of Health Roadmap Initiative ‘Re-engineering the Clinical Research Enterprise’ will take advantage of these recent changes to substantially enhance the potential for the performance of clinical and translational research in primary care. The ePCRN is providing a new model for clinical research in primary care led by the Federation of Practice-based Research Networks, representing over 6500 primary care physicians in the United States performing research in practices primarily committed to patient care, with the advanced Internet-2/Grid technologic infrastructure of the University of Minnesota, the University of California San Francisco (UCSF), and with the web-based primary care RCT support experience of the Midlands Research Practices Consortium (MidReC) in the UK and the American Academy of Family Physicians (AAFP). The ePCRN's sophisticated electronic support is being developed on the new open grid source architecture–data access and integration (OGSA-DAI) platform for very high-speed network communication. Involving over 100 clinics across the United States, this large NIH project is introducing to the clinics a standardized ‘gateway’ that uses the ASTM medical communication standard the Continuity of Care Record (CCR). Having recently completed its first clinical trial with 100 physicians in <6 weeks, the technology of the ePCRN offers to help fulfill the promise of Practice-based Research Networks to provide for large, fast clinical effectiveness trials in primary care. Some of the capabilities promised by the ePCRN include patient eligibility searches across wide geographic areas, virtual clinical trials, real-time video conferencing, remote instrumentation and the establishment of standardized linkages between primary care clinics. The development of a high-speed electronic research network on open-source Internet-2/Grid functionality that allows primary care clinics to participate as peers in clinical research may be a harbinger of a revolution in clinical and translational research and in primary care in the United States.
References
1 Zerhouni EA. Translational and clinical science–time for a new vision. N Engl J Med 2005; 353: 1621–1623.
2 Committee on Quality of Health Care in America IoM. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington DC: National Academy Press, 2001.
3 Woolf SH. Unhealthy Medicine All Breakthrough, No Follow-Through. Jan 2006.
4 Deckers JGM, Paget WJ, Schellevis FG, Fleming DM. European primary care surveillance networks: their structure and operation. Fam Pract 2006; 23: 151–158.
5 de Lusignan S, van Weel C. The use of routinely collected computer data for research in primary care: opportunities and challenges. Fam Pract 2006; 23: 253–263.
6 Generalizability in PBRN Studies, from Methods for Practice-Based Research Networks: Challenges and Opportunities. Leawood, Kansas: American Academy of Family Physicians, 2001.
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