Introduction
A major aim of evidence-based medicine is to protect patients from ineffective or harmful treatments while ensuring that appropriate treatments are offered. In an ideal world, once a treatment is rigorously evaluated, results are incorporated into clinical guidelines which, in turn, inform health care delivery policies. However, the process that leads to effective sustainable solutions to health problems is in fact nonlinear, and different forms of evidence are needed at different stages by different parties. Knowledge translation is a complex and multidimensional concept that demands a comprehensive understanding of its mechanisms, methods, and measurements, as well as of its influencing factors at the individual and contextual levels—and the interaction between both those levels.
This chapter begins by presenting the definitions of knowledge translation and discussing the underlying basis for translational research under three often-cited phases. We outline the differences between these phases and illustrate that each step can generate new research questions which must be answered through a research continuum that requires different methods and constant two-way engagement with the global research community. Then the knowledge translation strategies and their applications are explored, drawn from specific examples from the field of cardiovascular disease. Finally, several methods and approaches to training in knowledge translation, types of studies, and funding issues will be presented.
Definitions and Concepts
Many terms have been used to describe the process of putting knowledge into action, from the term “implementation science” used in the United Kingdom and Europe to the terms “knowledge transfer and uptake” used in the United States. In Canada, however, the terms “knowledge transfer and exchange” and “knowledge translation” are commonly used. The common element among these different terms is a move beyond the simple dissemination of knowledge into actual use of knowledge. Knowledge translation is the process which leads from evidence based medicine to sustainable solutions for health problems.
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Knowledge translation is defined by the Canadian Institutes of Health Research as a dynamic and iterative process that includes the synthesis, dissemination, exchange and ethically sound application of knowledge to improve health, provide more effective health services and products, and strengthen the health care system. This definition has been adapted by others, including the United States National Center for Dissemination of Disability Research and the World Health Organization.
Most recently, the National Center for the Dissemination of Disability Research proposed another working definition of knowledge translation as “the collaborative and systematic review, assessment, identification, aggregation, and practical application of high-quality disability and rehabilitation research by key stakeholders (ie, consumers, researchers, practitioners, and policymakers) for the purpose of improving the lives of individuals with disabilities.”
Characteristics of Knowledge Translation
Knowledge creation (ie, primary research), knowledge distillation (ie, the creation of systematic reviews and guidelines), and knowledge dissemination (ie, appearances in journals and presentations) are not enough on their own to ensure the use of knowledge in decision making. A key characteristic of knowledge translation is that it encompasses all steps between the creation of new knowledge and its application to yield beneficial outcomes for society. Essentially, knowledge translation is an interactive process underpinned by effective exchanges between researchers who create new knowledge and those who use it. As stated by Canadian Institutes of Health Research, bringing users and creators of knowledge together during all stages of the research cycle is fundamental to successful knowledge translation.
Knowledge translation strategies can help define research questions and hypotheses, select appropriate research methods, conduct the research itself, interpret and contextualize the research findings, and apply the findings to resolve practical issues and problems. Continuing dialogues, interactions, and partnerships within and between different groups of knowledge creators and users for all stages of the research process are integral parts of knowledge translation. For example, different interactive groups may include researchers within and across research disciplines; policymakers, planners, and managers throughout the health care, public health, and health public policy systems; health care providers in formal and informal systems of care; general public, patient groups, and those who help to shape their views and/or represent their interests, including the media, educators, nongovernmental organizations, and the voluntary sector; and the private sector, including venture capital firms, manufacturers, and distributors.
Translational Medicine and Translational Research
Fulfilling the promise of knowledge translation for improving the health and longevity of the world’s populations depends on developing broad-based teams of scientists and scholars who are able to focus their efforts to link basic scientific discoveries within the arena of clinical investigation, and translating the results of clinical trials into changes in clinical practice, informed by evidence from the social and political sciences. Thus translational research is the underlying basis for translational medicine and has three phases. The process is not necessarily linear, as each step can generate new research questions, which must be answered through a research continuum that requires different methods and constant two way engagement with the global research community (Lean, et al, 2008).
Phase 1 translational research is the research process that explores needs, develops potential treatments in basic laboratory research, and tests safety and efficacy, principally in randomized clinical trials. The concept arose from research into pharmacotherapy and formed the initial basis for evidence-based practice and clinical guidelines, now incorporated into translational medicine. In the case of drug discovery and development, translational research typically refers to the translation of laboratory-based research into real therapies for real patients. This is often called the “bench to bedside” definition. Many pharmaceutical companies are building (phase 1) translational medicine groups to facilitate the interaction between basic research and clinical medicine, particularly in clinical trials. The clinical evaluation of therapies drawn from other disciplines (eg, psychology, physical activity, nutritional) can also be included within phase 1 translational research.
For this area of research, namely the interface between basic science and clinical medicine, the endpoint is the production of a promising new treatment that can be used clinically or commercialized (“brought to market”). This enterprise is vital for implementing new approaches for prevention, diagnosis, and treatment of disease is essential for improving health.
Phase 2 translational research examines how findings from clinical science function when they are applied in routine clinical practice, as first described by Hiss in 2004. It thus addresses development and application of new technologies in a patient-driven environment where the emphasis is on real patients in real-life situations, where demographic factors and competing priorities modify clinical decisions, and treatment responses. Phase 2 translational research thus informs guidelines about needs, acceptability, effectiveness, and cost-efficiency in ecological settings and policies to promote uptake for optimal management and resource use.
Thus, phase 2 of translational research refers to translating clinical research into practice, ie, ensuring that new treatments and research knowledge actually reach the patients or populations for whom they are intended and are implemented correctly. As such, health services researchers and public health investigators whose studies focus on health care and health as the primary outcome play a prominent role in phase 2. The production of a new drug, an endpoint for “bench-to-bedside” translational research, is only the starting point for this second area of research. According to McGlynn et al (2003), US patients receive only half of recommended services. Phase 2 of translational research seeks to close that gap and improve quality by improving access, reorganizing and coordinating systems of care, helping clinicians and patients to change behaviors and make more informed choices, providing reminders and point-of-care decision support tools, and strengthening the patient-clinician relationship (Woolf, 2008).
Referring to T1 and T2 by the same name, knowledge translation, has become a source of some confusion. The two spheres are alike in name only. Their goals, settings, study designs, and investigators differ. T1 research requires mastery of molecular biology, genetics, and other basic sciences; appropriately trained clinical scientists working in strong laboratories and with cutting-edge technology; and a supportive infrastructure within the institution (Woolf , 2008).
In contrast, the “laboratory” for T2 research is the population and ambulatory care settings, where population-based interventions and practice-based research networks bring the results of T1 research to the public. T2 requires different research skills: mastery of the “implementation science” of fielding and evaluating interventions in real-world settings and of the disciplines that inform the design of those interventions, such as clinical epidemiology and evidence synthesis, communication theory, behavioral science, public policy, financing, organizational theory, system redesign, informatics, and mixed methods/qualitative research. T1 and T2 face different challenges. T1 struggles more with biological and technological mysteries, trial recruitment, and regulatory concerns. T2 struggles more with human behavior and organizational inertia, infrastructure and resource constraints, and the messiness of proving the effectiveness of “moving targets” under conditions that investigators cannot fully control (Woolf, 2008).
How attention and resources are apportioned to T1 and T2 matters because, for many diseases, T2 could save more lives than T1. The “bench-to-bedside” T1 enterprise occasionally yields breakthroughs that markedly improve the prognosis for a disease, but most new drugs and interventions produced by T1 only marginally improve efficacy. These incremental advances are certainly welcome, but patients might benefit even more—and more patients might benefit—if the health care system performed better in delivering existing treatments than in producing new ones. For example, increased administration of aspirin to eligible patients might prevent more strokes compared to the costs associated with developing a newer more potent antiplatelet agent. At a time when experts warn of the fragmented health care system and of a widening “chasm” in access, quality, and disparities, interventions to close these gaps—the work of T2—may do more to decrease morbidity and mortality than a new imaging device or class of drugs (Woolf, 2008).