Practice-based primary care research—translating research into practice through advanced technology

Abstract

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. 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. 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.’ 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. 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. 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. 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,