Translational science matters: forging partnerships between biomedical and behavioral science to advance the public’s health

Translational science matters: forging partnerships between biomedical and behavioral science to... Abstract The prevention and effective treatment of many chronic diseases such as cardiovascular disease, cancer and diabetes are dependent on behaviors such as not smoking, adopting a physically-active lifestyle, eating a healthy diet, and adhering to prescribed medical and behavioral regimens. Yet adoption and maintenance of these behaviors pose major challenges for individuals, their families and communities, as well as clinicians and health care systems. These challenges can best be met through the integration of the biomedical and behavioral sciences that is achieved by the formation of strategic partnerships between researchers and practitioners in these disciplines to address pressing clinical and public health problems. The National Institutes of Health has supported a number of clinical trials and research initiatives that demonstrate the value of biomedical and behavioral science partnerships in translating fundamental discoveries into significant improvements in health outcomes. We review several such examples of collaborations between biomedical and behavioral researchers, describe key initiatives focused on advancing a transdisciplinary translational perspective, and outline areas which require insights, tools and findings from both the biomedical and behavioral sciences to advance the public’s health. Implications Practice: Partnerships between researchers and clinicians can enhance the opportunity to leverage novel insights from biomedical and behavioral science research which are invaluable in understanding patient behaviors such as lack of adherence to practitioner recommendations. Policy: Strategic partnerships with researchers and practitioners provide in-depth perspectives on the challenges patients and research participants face thereby enriching their insights when formulating policy and legislation. Research: Strategic partnerships with practitioners provide invaluable insights into the challenges of translating scientific discoveries into routine clinical practice thereby enabling opportunities to address gaps in the translational process. INTRODUCTION As the lead agency for health research in the USA and the largest public source of funding for biomedical research in the world, the National Institutes of Health (NIH) has played a crucial role in seminal research discoveries that have fueled advances in health over the past century [1]. The dramatic declines in mortality rates from heart disease and stroke and the development of novel strategies for the prevention, treatment, and control of many diseases and injuries bear testament to these discoveries. Not surprisingly, a total of 149 NIH-funded investigators have been honored as sole or shared recipients of 88 Nobel Prizes for their groundbreaking achievements in physiology or medicine, chemistry, physics, and economic sciences [2]. In this article, we emphasize that the effective integration of biomedical and behavioral science insights is necessary for advancing the NIH mission of “Turning Discovery into Health” and for maximizing the return on investments. In this regard, we build on a previous editorial from the National Heart, Lung, and Blood Institute (NHLBI) more than two decades ago that highlighted the importance of the partnership between biomedical and behavioral science [3]. We begin by outlining the definition and role of translational science in health-related research, an approach that requires transcending disciplinary boundaries. We then describe examples of some of the successes and inherent challenges in biomedical and behavioral research, and use two major NIH-funded clinical trials to illustrate how integrating perspectives and key elements from each field is essential for moving health-related research forward. We close by discussing opportunities for biomedical and behavioral science investigators to partner in the endeavor to advance the public’s health. THE TRANSLATIONAL APPROACH TO HEALTH RESEARCH Translational research has been defined as “the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment and prevention of human disease” [4]. The ultimate goal is improving health outcomes rather than discovery or understanding for its own sake [5]. A number of models or frameworks have been proposed to describe the translational research continuum and its phases, including a six-stage transdisciplinary model recently proposed by Fishbein et al. [6] to guide prevention research. This model defines a series of research stages, progressing from basic discovery science (T0), through methods and intervention development (T1), to intervention testing and the building of a scientifically sound evidence-base (T2), and on to evaluation of interventions in community and clinical settings (T3), dissemination and implementation of the strategies as part of existing local and national infrastructures (T4), and finally, wide-scale global implementation with adaptations for variation in political, economic, and cultural systems [6]. Translational research often involves an interdisciplinary or transdisciplinary approach, as it requires integration across multiple scientific disciplines, with less emphasis on working within the discrete categories of basic versus applied research, and a greater focus on the continuous, interrelated and bidirectional nature of scientific inquiry. Thus, translational research has been characterized as “an overarching approach to discovery that steps over arbitrary, traditional barriers that divide medical specialties and separate basic science from medicine. [It] utilizes complementary skills and approaches of researchers from diverse disciplines to accelerate discovery” [7]. Collaboration is important at many different levels, “both within and across all translational stages between teams of basic and social scientists, intervention developers, organizational and community leaders, cross-sector agency staff, front-line service providers, dissemination and implementation scientists, funders, policymakers, and individuals whose behaviors are targeted for change” [8]. Essentially, a transdisciplinary translational approach to health-related research views partnering across disciplines to turn fundamental discoveries into real-world health outcomes as essential to achieving the greatest possible public health impact. EXAMPLES OF RESEARCH SUCCESSES, CHALLENGES, AND THE NEED FOR AN INTEGRATED APPROACH A decade after receiving the Nobel Prize for their outstanding discoveries in the regulation of cholesterol metabolism, Brown and Goldstein predicted the “end of heart attacks” and the end of “coronary disease as a major public health problem” early in this century [9]. This optimistic prediction was firmly based on four decades of progress in biomedical research and the increasing availability of statins that safely and effectively reduce plasma levels of low-density lipoprotein cholesterol resulting in marked reductions in deaths from heart attacks [9]. Consistent with this view, the Advisory Board of the First International Heart Health Conference stated 4 years earlier that “we have the scientific knowledge to create a world in which heart disease and stroke are rare” [10]. In this century, however, heart disease and stroke deaths are neither declining nor rare. Ischemic heart disease (IHD), the principal cause of heart attacks, remains the leading cause of death worldwide [11] and a major contributor to disability [12]. In fact, in 2013 alone, IHD and stroke collectively killed 12.9 million people, or one in four deaths worldwide, compared with one in five in 1990 [11]. In developing countries where nearly 80% of cardiovascular mortality occurs, deaths from all cardiovascular causes have increased more than 40% in women and over 60% in men since 1990, compared to 3.9% and 2.1%, respectively, in the developed world, which is largely a result of population growth, aging, and adverse risk factor trends [13]. Nearly one third of patients with and about one half without a history of heart attack do not adhere to effective evidence-based treatments [14]. As astutely pointed out by Greenland and Lloyd-Jones [15], “the failure of our research to reach full translation” is an important reason for the stark contrast between the optimistic predictions and the rising burden of global deaths from cardiovascular diseases today. Others have pointed out that much of our biomedical scientific discoveries is often lost in translation [16–18]. The behavioral arena faces a similar set of health needs, successes, and challenges: behaviors such as smoking, sedentary lifestyles, unhealthy diets, and poor adherence to medical and behavioral treatments are major contributors to premature death [19] and to the development, progression, and poor outcomes of many chronic diseases such as cancer, cardiovascular disease, and diabetes. It is now widely recognized that the successful prevention and treatment of these diseases is highly dependent on behavior. Adopting a healthy lifestyle has been shown to delay and even reduce the deleterious effects and high costs of chronic disease; for example, research shows that people with healthy lifestyles have less or delayed disability relative to those who do not engage in such behaviors [20, 21]. Where behavioral treatments have succeeded in reducing smoking, producing weight loss, increasing physical activity, and reducing sodium, saturated fat, and caloric intake, these behavioral changes have been shown to produce measurable, cost-effective improvements in important clinical outcomes [22–26]. Unfortunately, initiating and maintaining healthy behavioral changes is difficult for most people, and many behavioral interventions have not produced the kind of robust improvements in behavioral risk factors necessary to show clinically significant and sustained physical health benefits [27–32]. Even the most successful behavioral treatments often have short-lived effects. Studies show, for example, that even after losing significant amounts of weight during the first 6 months of an intervention, many participants in weight loss trials begin to gain back much of the lost weight [33]. Successes and challenges exist in the conduct of both biomedical and behavioral science research, but only by integrating key insights from each of these fields we can achieve the greatest impacts on the public’s health. For example, a major “lesson learned” from the history of medicine is that the promise of biomedical research for saving and extending lives can only be fully realized “when it is combined with knowledge gleaned from the behavioral and social sciences that improves the ability of individuals, families, practitioners, and communities to access, adopt, and optimally utilize drugs, devices, and other medical regimens.” Likewise, health-related behavioral research achieves its greatest impact “when it produces meaningful and sustainable effects on clinical and public health outcomes that have been identified as important research targets by the end-users of research”—the patients, practitioners, and other stakeholders directly affected by the relevant health condition or medical practice. Ultimately, then, the intervention impact is likely to be maximized when we work together across disciplines to translate biomedical and behavioral discoveries to advance the public’s health, rather than work within our separate “silos.” TURNING DISCOVERY INTO HEALTH: A TALE OF TWO TRIALS The diabetes prevention program The Diabetes Prevention Program (DPP) was a major multicenter clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) involving 3,234 overweight and pre-diabetic participants from 27 clinical centers in the USA. Individuals enrolled in the DPP were randomly assigned to one of three conditions: the first involved participation in a behaviorally based weight loss regimen; the second involved the use of the oral diabetes drug metformin (Glucophage); and the third was a usual care control condition. The DPP investigators found that participants who lost a modest amount of weight through dietary changes and increased physical activity sharply reduced their chances of developing diabetes relative to taking metformin and to usual care. The results showed that a 7% weight reduction and 2.5 hr per week activity increase led to a “58% reduction” in the cumulative incidence of Type 2 diabetes in older insulin-resistant individuals [22], thus illustrating the potential of behavioral interventions to affect clinically important endpoints of importance to the “end-users” of medicine. Two aspects of the DPP are notable here: first, similar to the development of efficacious biomedical treatments, the behaviorally based weight loss intervention used was based on a body of observational and experimental research aimed at translating knowledge about dietary and physical activity behaviors into an intervention capable of producing a significant degree of weight loss in order to maximize its ability to improve the ultimate health outcomes of interest. In addition, rather than focusing only on intermediate behavioral targets (diet, exercise) as outcomes, the DPP researchers set their sights on a more ambitious goal: they designed their randomized clinical trial to determine whether changes in these intermediate behaviorally based outcomes would affect an important clinically significant endpoint: diabetes incidence. By selecting a primary outcome that reflected an important physical health outcome, they ensured that the results would be of interest not only to behavioral researchers, but to the medical researchers and practitioners who are the “gatekeepers” of biomedical science and clinical care. The DPP illustrates the importance of a long-term, progressive approach to behavioral intervention research that (a) begins with translation of fundamental knowledge about human behavior to the development of a behavioral treatment and (b) culminates in a Phase III behavioral efficacy trial to evaluate the effects of the intervention on a clinically significant endpoint. By adopting a paradigm that has been successfully utilized by biomedical researchers to show the value of a treatment on a physical health outcome, the DPP was a transformative study that demonstrated the potential for behavioral science to address pressing public health needs. The systolic blood pressure intervention trial The Systolic Blood Pressure Intervention Trial (SPRINT) was an NHLBI-funded multicenter, randomized, controlled trial, compared standard hypertension treatment (using a target systolic blood pressure less than 140 mm Hg) to a more intensive treatment strategy (target systolic blood pressure less than 120 mmHg) among high-risk participants defined by the presence of chronic kidney disease, cardiovascular disease, or age 75 years or older [34]. The SPRINT was terminated early because the more intense treatment strategy reduced rates of cardiovascular events, such as heart attack, heart failure, and stroke, by 25%. In addition, the risk of death from all causes was reduced by 27% compared to the standard treatment strategy [35]. It is widely recognized that these results have the potential not only to change clinical practice but also save lives for decades to come [36, 37]. The results of SPRINT illustrate the enormous promise of biomedical science to improve the Nation’s health. However, they also point to the critical role of behavioral science research in enabling biomedical science to achieve its full potential in terms of lives saved and extended. Virtually all of the advances made in preventive care and treatment can improve health outcomes “only when” combined with strategies, based on behavioral science research, that ensure patient adherence to behavioral and medical regimens and that facilitate provider and healthcare system implementation of recommended preventive and treatment guidelines. The value of adding behavioral science to the mix is summarized in Surgeon General Dr. Everett Koop’s famous statement: “Drugs don’t work in patients who don’t take them.” The truth is, behavior is an essential component of many of the cutting edge advances made by biomedical science, from medications that effectively treat high blood pressure and high blood cholesterol to antiretroviral therapies, the new oral chemotherapies, and the human papilloma virus vaccine. For these scientific advances to make a difference in health, individuals must participate in screening and treatment visits, recognize signs and symptoms of disease and present themselves for diagnosis and treatment as needed, adhere to the recommended medical or behavioral regimen, and engage in other preventive and treatment-related behaviors. Furthermore, the behavior of providers and healthcare systems is important to achieve good health outcomes: for example, clinicians must be aware of and “treat to guidelines,” and the systems of care they inhabit must be organized to support optimal provider behavior. Finally, the characteristics of communities and the environments in which individuals reside—including families, social networks, neighborhoods, schools, churches and community organizations, as well as physical and policy environments—are critical elements in shaping human behavior, and therefore play important roles in facilitating healthy choices and enabling the full realization of benefits from biomedical research. Achieving the expected benefits of the SPRINT will therefore require behavior change at multiple levels involving many actors including patients, healthcare providers and health systems, communities, and the environments in which individuals and families live. The task is complex and challenging—as one editorial noted, “Deeply ingrained behaviors are difficult—but not impossible—to change…”…[37]—but improving our ability to address the behavioral aspects of prevention and treatment is essential to fulfilling NIH’s mission and advancing its vision of optimal health for all. THE ROLE AND PROMISE OF TRANSLATIONAL TRANSDISCIPLINARY SCIENCE Both early-phase (i.e. “bench-to-bedside”) and later-phase (e.g. dissemination and implementation) research are needed to ensure that our biomedical and behavioral discoveries lead to better health. Just as with new drugs and devices, we must continue to refresh the “pipeline” of strategies available, not just in the biomedical arena, but in the behavioral and social sciences as well. Novel approaches are needed to promote healthy lifestyles and adherence to recommended preventive and therapeutic regimens, approaches that can be accelerated through the development and testing of new behavioral treatments based on basic behavioral and social science research discoveries (a process that is analogous to the early, “bench-to-bedside” phase of biomedical research). In addition, the knowledge we currently have about lifesaving treatments—for example, how to promote weight loss or lower blood pressure to optimal levels—must be disseminated to and implemented by clinicians and systems of care in as timely and widespread a manner as possible. Early-phase translation: developing and testing new behavioral interventions We are currently experiencing a revolution in our understanding of the psychological, social, neural, genomic, physiologic, and environmental determinants of human behavior, leading to new and important insights about why people think, feel, believe, and behave as they do. This research is leading to identification of new targets for behavioral interventions that can ultimately be used to improve behavioral risk factors for chronic diseases. Recent findings in psychology, cognitive neuroscience, and behavioral economics are implicating psychological processes such as self-control failure (also known as executive dysfunction or impulsivity), delay discounting (the over-valuation of immediate consequences over long-term ones), and reinforcement pathology (valuation of a substance on which an individual is dependent, such as a drug, alcohol, or even food) over other commodities as important drivers of the unhealthy decisions and choices underlying behaviorally based risk factors such as drug and alcohol abuse, smoking, and obesity [38–43]. By better understanding the underpinnings of human behavior and what promotes healthy and unhealthy behaviors, we can design better, more targeted interventions to alter and sustain positive, healthy behaviors including adherence to medical and behavioral regimens. An example of a novel approach to encouraging healthier choices based on the basic behavioral science research on impulsivity, delay discounting, and reinforcement pathology is episodic future thinking, which uses imagery of future desired goals to help mitigate impulsive decision-making and shows promise as a strategy to promote better choices across a variety of domains, including diet, physical activity, and smoking [44]. Recently, a number of NIH-initiated initiatives and programs have focused on the area of early-phase translational research, seeking to accelerate the pathway through which basic behavioral science research findings are developed into potentially more effective interventions. These programs include the Science of Behavior Change (SOBC) Common Fund program (https://commonfund.nih.gov/behaviorchange/index) which supports eight research sites and a Research Coordinating Center to implement a mechanisms-focused, experimental medicine approach to behavior change research that involves identifying an intervention target, developing assays (measures) to permit verification of the target, engaging the target through experimentation or intervention, and testing the degree to which target engagement produces the desired behavior change. Another example of an NIH program supporting early-phase translational research is the Obesity-Related Behavioral Intervention Trials (ORBIT) consortium (www.nihorbit.org), a trans-NIH cooperative agreement that supports seven interdisciplinary teams of basic and applied behavioral and social science researchers who are developing, testing, and refining novel interventions to translate findings from basic research on human behavior into more effective clinical, community, and population interventions to reduce obesity and alter obesity-related health behaviors (e.g. diet, physical activity). One of the main products of ORBIT is a framework (the ORBIT model for the development of treatments for chronic diseases) which focuses exclusively on the early-phase (pre-efficacy) development of behavioral treatments, primarily for chronic physical diseases [45]. The ORBIT model is a bidirectional, flexible, and iterative two-phased approach to behavioral treatment development based on the drug development process. Central features of the model include a priori identification of a clinical question or problem that could be addressed by a behavioral treatment and specification of the degree of change in the behavioral treatment target needed to achieve clinically meaningful change in a particular clinical or health outcome. This emphasis on targeting and achieving clinically meaningful, not just statistically significant, effects on behavioral risk factors causally related to important clinical or public health outcomes highlights the importance of cross-disciplinary partnerships between biomedical and behavioral researchers and practitioners to enable progress in tackling the behaviorally based health problems the underlying many chronic diseases. Later-phase translation: dissemination and implementation research Rabin et al. [46] have defined dissemination and implementation (D&I), respectively, as the “active approach of spreading evidence-based interventions to the target audience via determined channels using planned strategies,” and the “process of putting to use or integrating evidence-based interventions within a setting.” Unlike early-stage translational research that specifically targets technologies and therapeutics that are poised for proof of concept, prototype development, feasibility studies, and commercialization [47, 48], D&I research addresses strategies for spreading proven evidence-based interventions and research insights into the clinic or community and requires input from both biomedical and behavioral researchers as well as front-line clinical and public health practitioners. There are several examples of successful D&I efforts in cardiovascular health, especially in the treatment and control of hypertension [49–54] and community-wide programs targeting cardiovascular risk factors and behavior changes with evidence of sustained mortality reduction and health impact beyond 40 years [55]. Recently, Neta et al. [56] identified 67 research grants with a focus on D&I research awarded by the National Cancer Institute from 2003 to 2012. The R01 was the most common mechanism for funding. They also demonstrated that 16 NIH institutes and centers participate in the trans-NIH funding announcement and that interest in supporting D&I research is increasing [56]. IMPORTANCE OF RESEARCH TRAINING AND PROFESSIONAL EDUCATION Research training and career development are crucial avenues for ensuring sustained success in biomedical and behavioral science research. As the Institute of Medicine stated, the extent to which we are able to further improve the health of the public in the 21st century “depends, in large part, upon the quality and preparedness of the public health workforce” which in turn depends on training and professional education [57]. There is even greater need to assure that training and career development cut across these disciplines in order to further strengthen opportunities for sustained partnerships. There is increasing support at NIH for scientific conferences and research training for D&I research [58]. However, training in the methodologies and approaches most useful for early-phase behavioral translation is lacking. This is an area where additional programs are needed, including large-scale conferences, Summer Institutes, methods workshops, and initiatives aimed at training researchers in the design and conduct of studies translating findings from basic behavioral science into behavioral interventions. CONCLUSIONS The National Institutes of Health has played a crucial role in fundamental discoveries that have fueled advances in health worldwide. Successfully translating these research advances to maximize public health impact requires effective partnerships between biomedical and behavioral scientists as we work collectively with patients, healthcare providers, policymakers, and other stakeholders. This endeavor is neither simple nor easy given the many challenges that exist in the effective translation of research discoveries into effective and widely utilized public health strategies. Nevertheless, opportunities exist for developing partnerships across biomedical and behavioral arenas to facilitate the translation of research discoveries into health. One area of opportunity involves the dissemination and use of frameworks such as the ORBIT model to guide behavioral intervention development. The ORBIT model exemplifies a cross-disciplinary approach in which clinical and public health needs are used to direct the research questions being asked at the outset of the translational process and the interventions being developed to target clinically significant changes in health behaviors, thus maximizing the potential of behavioral treatments to affect health outcomes. For early-phase behavioral translation, more integration of cross-disciplinary teams across both behavioral and biomedical arenas is needed, ideally involving programs of research that bring together basic behavioral and social scientists with applied behavioral researchers as well as with clinical researchers, practitioners and public health scientists to solve specific problems related to clinical and public health practice. Also helpful are workshops and conferences that bring different disciplines together and enable exchanges of methods, approaches, and problem-solving techniques across areas of expertise. These efforts can be greatly accelerated through the development of training and methods development, funding mechanisms and review groups that are targeted to early-phase behavioral science translation so that the appropriate expertise to support and review such programs is available, leading to greater recognition and sustainability of this area of translation. For late-phase behavioral translation, the formation of partnerships across Federal agencies in both the health and nonhealth sectors as well as with private sector entities and nongovernmental organizations to leverage support for late-phase research is crucial. It will also be important to develop research training and career development pathways to address current and future workforce needs. In addition, attention to methodological rigor, development of appropriate metrics, and models to enable broader knowledge, greater acceptance, and reach within both the biomedical and behavioral communities is essential for full realization of the benefits of advancements in both biomedical and behavioral preventive and therapeutic strategies. Acknowledgments The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; National Cancer Institute; National Institutes of Health; or the United States Department of Health and Human Services. The authors disclose that the findings and views expressed in this article have not been previously published and that the manuscript is not being simultaneously submitted elsewhere. In addition, the contents have not been previously published. 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Google Scholar CrossRef Search ADS PubMed 56. Neta G , Sanchez MA , Chambers DA , et al. Implementation science in cancer prevention and control: a decade of grant funding by the National Cancer Institute and future directions . Implement Sci . 2015 ; 10(4):1–10 . 57. Gebbie K , Rosenstock L , Hernandez LM. Who Will Keep the Public Healthy? Educating Public Health Professionals for the 21st Century . Washington, DC : The National Academies Press ; 2003 . 58. Meissner HI , Glasgow RE , Vinson CA , et al. The U.S. training institute for dissemination and implementation research in health . Implement Sci . 2013 ; 8(12):1–9 . Published by Oxford University Press on behalf of the Society of Behavioral Medicine 2018. This work is written by (a) US Government employees(s) and is in the public domain in the US. This work is written by (a) US Government employee(s) and is in the public domain in the US. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Translational Behavioral Medicine Oxford University Press

Translational science matters: forging partnerships between biomedical and behavioral science to advance the public’s health

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Published by Oxford University Press on behalf of the Society of Behavioral Medicine 2018. This work is written by (a) US Government employees(s) and is in the public domain in the US.
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1869-6716
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Abstract

Abstract The prevention and effective treatment of many chronic diseases such as cardiovascular disease, cancer and diabetes are dependent on behaviors such as not smoking, adopting a physically-active lifestyle, eating a healthy diet, and adhering to prescribed medical and behavioral regimens. Yet adoption and maintenance of these behaviors pose major challenges for individuals, their families and communities, as well as clinicians and health care systems. These challenges can best be met through the integration of the biomedical and behavioral sciences that is achieved by the formation of strategic partnerships between researchers and practitioners in these disciplines to address pressing clinical and public health problems. The National Institutes of Health has supported a number of clinical trials and research initiatives that demonstrate the value of biomedical and behavioral science partnerships in translating fundamental discoveries into significant improvements in health outcomes. We review several such examples of collaborations between biomedical and behavioral researchers, describe key initiatives focused on advancing a transdisciplinary translational perspective, and outline areas which require insights, tools and findings from both the biomedical and behavioral sciences to advance the public’s health. Implications Practice: Partnerships between researchers and clinicians can enhance the opportunity to leverage novel insights from biomedical and behavioral science research which are invaluable in understanding patient behaviors such as lack of adherence to practitioner recommendations. Policy: Strategic partnerships with researchers and practitioners provide in-depth perspectives on the challenges patients and research participants face thereby enriching their insights when formulating policy and legislation. Research: Strategic partnerships with practitioners provide invaluable insights into the challenges of translating scientific discoveries into routine clinical practice thereby enabling opportunities to address gaps in the translational process. INTRODUCTION As the lead agency for health research in the USA and the largest public source of funding for biomedical research in the world, the National Institutes of Health (NIH) has played a crucial role in seminal research discoveries that have fueled advances in health over the past century [1]. The dramatic declines in mortality rates from heart disease and stroke and the development of novel strategies for the prevention, treatment, and control of many diseases and injuries bear testament to these discoveries. Not surprisingly, a total of 149 NIH-funded investigators have been honored as sole or shared recipients of 88 Nobel Prizes for their groundbreaking achievements in physiology or medicine, chemistry, physics, and economic sciences [2]. In this article, we emphasize that the effective integration of biomedical and behavioral science insights is necessary for advancing the NIH mission of “Turning Discovery into Health” and for maximizing the return on investments. In this regard, we build on a previous editorial from the National Heart, Lung, and Blood Institute (NHLBI) more than two decades ago that highlighted the importance of the partnership between biomedical and behavioral science [3]. We begin by outlining the definition and role of translational science in health-related research, an approach that requires transcending disciplinary boundaries. We then describe examples of some of the successes and inherent challenges in biomedical and behavioral research, and use two major NIH-funded clinical trials to illustrate how integrating perspectives and key elements from each field is essential for moving health-related research forward. We close by discussing opportunities for biomedical and behavioral science investigators to partner in the endeavor to advance the public’s health. THE TRANSLATIONAL APPROACH TO HEALTH RESEARCH Translational research has been defined as “the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment and prevention of human disease” [4]. The ultimate goal is improving health outcomes rather than discovery or understanding for its own sake [5]. A number of models or frameworks have been proposed to describe the translational research continuum and its phases, including a six-stage transdisciplinary model recently proposed by Fishbein et al. [6] to guide prevention research. This model defines a series of research stages, progressing from basic discovery science (T0), through methods and intervention development (T1), to intervention testing and the building of a scientifically sound evidence-base (T2), and on to evaluation of interventions in community and clinical settings (T3), dissemination and implementation of the strategies as part of existing local and national infrastructures (T4), and finally, wide-scale global implementation with adaptations for variation in political, economic, and cultural systems [6]. Translational research often involves an interdisciplinary or transdisciplinary approach, as it requires integration across multiple scientific disciplines, with less emphasis on working within the discrete categories of basic versus applied research, and a greater focus on the continuous, interrelated and bidirectional nature of scientific inquiry. Thus, translational research has been characterized as “an overarching approach to discovery that steps over arbitrary, traditional barriers that divide medical specialties and separate basic science from medicine. [It] utilizes complementary skills and approaches of researchers from diverse disciplines to accelerate discovery” [7]. Collaboration is important at many different levels, “both within and across all translational stages between teams of basic and social scientists, intervention developers, organizational and community leaders, cross-sector agency staff, front-line service providers, dissemination and implementation scientists, funders, policymakers, and individuals whose behaviors are targeted for change” [8]. Essentially, a transdisciplinary translational approach to health-related research views partnering across disciplines to turn fundamental discoveries into real-world health outcomes as essential to achieving the greatest possible public health impact. EXAMPLES OF RESEARCH SUCCESSES, CHALLENGES, AND THE NEED FOR AN INTEGRATED APPROACH A decade after receiving the Nobel Prize for their outstanding discoveries in the regulation of cholesterol metabolism, Brown and Goldstein predicted the “end of heart attacks” and the end of “coronary disease as a major public health problem” early in this century [9]. This optimistic prediction was firmly based on four decades of progress in biomedical research and the increasing availability of statins that safely and effectively reduce plasma levels of low-density lipoprotein cholesterol resulting in marked reductions in deaths from heart attacks [9]. Consistent with this view, the Advisory Board of the First International Heart Health Conference stated 4 years earlier that “we have the scientific knowledge to create a world in which heart disease and stroke are rare” [10]. In this century, however, heart disease and stroke deaths are neither declining nor rare. Ischemic heart disease (IHD), the principal cause of heart attacks, remains the leading cause of death worldwide [11] and a major contributor to disability [12]. In fact, in 2013 alone, IHD and stroke collectively killed 12.9 million people, or one in four deaths worldwide, compared with one in five in 1990 [11]. In developing countries where nearly 80% of cardiovascular mortality occurs, deaths from all cardiovascular causes have increased more than 40% in women and over 60% in men since 1990, compared to 3.9% and 2.1%, respectively, in the developed world, which is largely a result of population growth, aging, and adverse risk factor trends [13]. Nearly one third of patients with and about one half without a history of heart attack do not adhere to effective evidence-based treatments [14]. As astutely pointed out by Greenland and Lloyd-Jones [15], “the failure of our research to reach full translation” is an important reason for the stark contrast between the optimistic predictions and the rising burden of global deaths from cardiovascular diseases today. Others have pointed out that much of our biomedical scientific discoveries is often lost in translation [16–18]. The behavioral arena faces a similar set of health needs, successes, and challenges: behaviors such as smoking, sedentary lifestyles, unhealthy diets, and poor adherence to medical and behavioral treatments are major contributors to premature death [19] and to the development, progression, and poor outcomes of many chronic diseases such as cancer, cardiovascular disease, and diabetes. It is now widely recognized that the successful prevention and treatment of these diseases is highly dependent on behavior. Adopting a healthy lifestyle has been shown to delay and even reduce the deleterious effects and high costs of chronic disease; for example, research shows that people with healthy lifestyles have less or delayed disability relative to those who do not engage in such behaviors [20, 21]. Where behavioral treatments have succeeded in reducing smoking, producing weight loss, increasing physical activity, and reducing sodium, saturated fat, and caloric intake, these behavioral changes have been shown to produce measurable, cost-effective improvements in important clinical outcomes [22–26]. Unfortunately, initiating and maintaining healthy behavioral changes is difficult for most people, and many behavioral interventions have not produced the kind of robust improvements in behavioral risk factors necessary to show clinically significant and sustained physical health benefits [27–32]. Even the most successful behavioral treatments often have short-lived effects. Studies show, for example, that even after losing significant amounts of weight during the first 6 months of an intervention, many participants in weight loss trials begin to gain back much of the lost weight [33]. Successes and challenges exist in the conduct of both biomedical and behavioral science research, but only by integrating key insights from each of these fields we can achieve the greatest impacts on the public’s health. For example, a major “lesson learned” from the history of medicine is that the promise of biomedical research for saving and extending lives can only be fully realized “when it is combined with knowledge gleaned from the behavioral and social sciences that improves the ability of individuals, families, practitioners, and communities to access, adopt, and optimally utilize drugs, devices, and other medical regimens.” Likewise, health-related behavioral research achieves its greatest impact “when it produces meaningful and sustainable effects on clinical and public health outcomes that have been identified as important research targets by the end-users of research”—the patients, practitioners, and other stakeholders directly affected by the relevant health condition or medical practice. Ultimately, then, the intervention impact is likely to be maximized when we work together across disciplines to translate biomedical and behavioral discoveries to advance the public’s health, rather than work within our separate “silos.” TURNING DISCOVERY INTO HEALTH: A TALE OF TWO TRIALS The diabetes prevention program The Diabetes Prevention Program (DPP) was a major multicenter clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) involving 3,234 overweight and pre-diabetic participants from 27 clinical centers in the USA. Individuals enrolled in the DPP were randomly assigned to one of three conditions: the first involved participation in a behaviorally based weight loss regimen; the second involved the use of the oral diabetes drug metformin (Glucophage); and the third was a usual care control condition. The DPP investigators found that participants who lost a modest amount of weight through dietary changes and increased physical activity sharply reduced their chances of developing diabetes relative to taking metformin and to usual care. The results showed that a 7% weight reduction and 2.5 hr per week activity increase led to a “58% reduction” in the cumulative incidence of Type 2 diabetes in older insulin-resistant individuals [22], thus illustrating the potential of behavioral interventions to affect clinically important endpoints of importance to the “end-users” of medicine. Two aspects of the DPP are notable here: first, similar to the development of efficacious biomedical treatments, the behaviorally based weight loss intervention used was based on a body of observational and experimental research aimed at translating knowledge about dietary and physical activity behaviors into an intervention capable of producing a significant degree of weight loss in order to maximize its ability to improve the ultimate health outcomes of interest. In addition, rather than focusing only on intermediate behavioral targets (diet, exercise) as outcomes, the DPP researchers set their sights on a more ambitious goal: they designed their randomized clinical trial to determine whether changes in these intermediate behaviorally based outcomes would affect an important clinically significant endpoint: diabetes incidence. By selecting a primary outcome that reflected an important physical health outcome, they ensured that the results would be of interest not only to behavioral researchers, but to the medical researchers and practitioners who are the “gatekeepers” of biomedical science and clinical care. The DPP illustrates the importance of a long-term, progressive approach to behavioral intervention research that (a) begins with translation of fundamental knowledge about human behavior to the development of a behavioral treatment and (b) culminates in a Phase III behavioral efficacy trial to evaluate the effects of the intervention on a clinically significant endpoint. By adopting a paradigm that has been successfully utilized by biomedical researchers to show the value of a treatment on a physical health outcome, the DPP was a transformative study that demonstrated the potential for behavioral science to address pressing public health needs. The systolic blood pressure intervention trial The Systolic Blood Pressure Intervention Trial (SPRINT) was an NHLBI-funded multicenter, randomized, controlled trial, compared standard hypertension treatment (using a target systolic blood pressure less than 140 mm Hg) to a more intensive treatment strategy (target systolic blood pressure less than 120 mmHg) among high-risk participants defined by the presence of chronic kidney disease, cardiovascular disease, or age 75 years or older [34]. The SPRINT was terminated early because the more intense treatment strategy reduced rates of cardiovascular events, such as heart attack, heart failure, and stroke, by 25%. In addition, the risk of death from all causes was reduced by 27% compared to the standard treatment strategy [35]. It is widely recognized that these results have the potential not only to change clinical practice but also save lives for decades to come [36, 37]. The results of SPRINT illustrate the enormous promise of biomedical science to improve the Nation’s health. However, they also point to the critical role of behavioral science research in enabling biomedical science to achieve its full potential in terms of lives saved and extended. Virtually all of the advances made in preventive care and treatment can improve health outcomes “only when” combined with strategies, based on behavioral science research, that ensure patient adherence to behavioral and medical regimens and that facilitate provider and healthcare system implementation of recommended preventive and treatment guidelines. The value of adding behavioral science to the mix is summarized in Surgeon General Dr. Everett Koop’s famous statement: “Drugs don’t work in patients who don’t take them.” The truth is, behavior is an essential component of many of the cutting edge advances made by biomedical science, from medications that effectively treat high blood pressure and high blood cholesterol to antiretroviral therapies, the new oral chemotherapies, and the human papilloma virus vaccine. For these scientific advances to make a difference in health, individuals must participate in screening and treatment visits, recognize signs and symptoms of disease and present themselves for diagnosis and treatment as needed, adhere to the recommended medical or behavioral regimen, and engage in other preventive and treatment-related behaviors. Furthermore, the behavior of providers and healthcare systems is important to achieve good health outcomes: for example, clinicians must be aware of and “treat to guidelines,” and the systems of care they inhabit must be organized to support optimal provider behavior. Finally, the characteristics of communities and the environments in which individuals reside—including families, social networks, neighborhoods, schools, churches and community organizations, as well as physical and policy environments—are critical elements in shaping human behavior, and therefore play important roles in facilitating healthy choices and enabling the full realization of benefits from biomedical research. Achieving the expected benefits of the SPRINT will therefore require behavior change at multiple levels involving many actors including patients, healthcare providers and health systems, communities, and the environments in which individuals and families live. The task is complex and challenging—as one editorial noted, “Deeply ingrained behaviors are difficult—but not impossible—to change…”…[37]—but improving our ability to address the behavioral aspects of prevention and treatment is essential to fulfilling NIH’s mission and advancing its vision of optimal health for all. THE ROLE AND PROMISE OF TRANSLATIONAL TRANSDISCIPLINARY SCIENCE Both early-phase (i.e. “bench-to-bedside”) and later-phase (e.g. dissemination and implementation) research are needed to ensure that our biomedical and behavioral discoveries lead to better health. Just as with new drugs and devices, we must continue to refresh the “pipeline” of strategies available, not just in the biomedical arena, but in the behavioral and social sciences as well. Novel approaches are needed to promote healthy lifestyles and adherence to recommended preventive and therapeutic regimens, approaches that can be accelerated through the development and testing of new behavioral treatments based on basic behavioral and social science research discoveries (a process that is analogous to the early, “bench-to-bedside” phase of biomedical research). In addition, the knowledge we currently have about lifesaving treatments—for example, how to promote weight loss or lower blood pressure to optimal levels—must be disseminated to and implemented by clinicians and systems of care in as timely and widespread a manner as possible. Early-phase translation: developing and testing new behavioral interventions We are currently experiencing a revolution in our understanding of the psychological, social, neural, genomic, physiologic, and environmental determinants of human behavior, leading to new and important insights about why people think, feel, believe, and behave as they do. This research is leading to identification of new targets for behavioral interventions that can ultimately be used to improve behavioral risk factors for chronic diseases. Recent findings in psychology, cognitive neuroscience, and behavioral economics are implicating psychological processes such as self-control failure (also known as executive dysfunction or impulsivity), delay discounting (the over-valuation of immediate consequences over long-term ones), and reinforcement pathology (valuation of a substance on which an individual is dependent, such as a drug, alcohol, or even food) over other commodities as important drivers of the unhealthy decisions and choices underlying behaviorally based risk factors such as drug and alcohol abuse, smoking, and obesity [38–43]. By better understanding the underpinnings of human behavior and what promotes healthy and unhealthy behaviors, we can design better, more targeted interventions to alter and sustain positive, healthy behaviors including adherence to medical and behavioral regimens. An example of a novel approach to encouraging healthier choices based on the basic behavioral science research on impulsivity, delay discounting, and reinforcement pathology is episodic future thinking, which uses imagery of future desired goals to help mitigate impulsive decision-making and shows promise as a strategy to promote better choices across a variety of domains, including diet, physical activity, and smoking [44]. Recently, a number of NIH-initiated initiatives and programs have focused on the area of early-phase translational research, seeking to accelerate the pathway through which basic behavioral science research findings are developed into potentially more effective interventions. These programs include the Science of Behavior Change (SOBC) Common Fund program (https://commonfund.nih.gov/behaviorchange/index) which supports eight research sites and a Research Coordinating Center to implement a mechanisms-focused, experimental medicine approach to behavior change research that involves identifying an intervention target, developing assays (measures) to permit verification of the target, engaging the target through experimentation or intervention, and testing the degree to which target engagement produces the desired behavior change. Another example of an NIH program supporting early-phase translational research is the Obesity-Related Behavioral Intervention Trials (ORBIT) consortium (www.nihorbit.org), a trans-NIH cooperative agreement that supports seven interdisciplinary teams of basic and applied behavioral and social science researchers who are developing, testing, and refining novel interventions to translate findings from basic research on human behavior into more effective clinical, community, and population interventions to reduce obesity and alter obesity-related health behaviors (e.g. diet, physical activity). One of the main products of ORBIT is a framework (the ORBIT model for the development of treatments for chronic diseases) which focuses exclusively on the early-phase (pre-efficacy) development of behavioral treatments, primarily for chronic physical diseases [45]. The ORBIT model is a bidirectional, flexible, and iterative two-phased approach to behavioral treatment development based on the drug development process. Central features of the model include a priori identification of a clinical question or problem that could be addressed by a behavioral treatment and specification of the degree of change in the behavioral treatment target needed to achieve clinically meaningful change in a particular clinical or health outcome. This emphasis on targeting and achieving clinically meaningful, not just statistically significant, effects on behavioral risk factors causally related to important clinical or public health outcomes highlights the importance of cross-disciplinary partnerships between biomedical and behavioral researchers and practitioners to enable progress in tackling the behaviorally based health problems the underlying many chronic diseases. Later-phase translation: dissemination and implementation research Rabin et al. [46] have defined dissemination and implementation (D&I), respectively, as the “active approach of spreading evidence-based interventions to the target audience via determined channels using planned strategies,” and the “process of putting to use or integrating evidence-based interventions within a setting.” Unlike early-stage translational research that specifically targets technologies and therapeutics that are poised for proof of concept, prototype development, feasibility studies, and commercialization [47, 48], D&I research addresses strategies for spreading proven evidence-based interventions and research insights into the clinic or community and requires input from both biomedical and behavioral researchers as well as front-line clinical and public health practitioners. There are several examples of successful D&I efforts in cardiovascular health, especially in the treatment and control of hypertension [49–54] and community-wide programs targeting cardiovascular risk factors and behavior changes with evidence of sustained mortality reduction and health impact beyond 40 years [55]. Recently, Neta et al. [56] identified 67 research grants with a focus on D&I research awarded by the National Cancer Institute from 2003 to 2012. The R01 was the most common mechanism for funding. They also demonstrated that 16 NIH institutes and centers participate in the trans-NIH funding announcement and that interest in supporting D&I research is increasing [56]. IMPORTANCE OF RESEARCH TRAINING AND PROFESSIONAL EDUCATION Research training and career development are crucial avenues for ensuring sustained success in biomedical and behavioral science research. As the Institute of Medicine stated, the extent to which we are able to further improve the health of the public in the 21st century “depends, in large part, upon the quality and preparedness of the public health workforce” which in turn depends on training and professional education [57]. There is even greater need to assure that training and career development cut across these disciplines in order to further strengthen opportunities for sustained partnerships. There is increasing support at NIH for scientific conferences and research training for D&I research [58]. However, training in the methodologies and approaches most useful for early-phase behavioral translation is lacking. This is an area where additional programs are needed, including large-scale conferences, Summer Institutes, methods workshops, and initiatives aimed at training researchers in the design and conduct of studies translating findings from basic behavioral science into behavioral interventions. CONCLUSIONS The National Institutes of Health has played a crucial role in fundamental discoveries that have fueled advances in health worldwide. Successfully translating these research advances to maximize public health impact requires effective partnerships between biomedical and behavioral scientists as we work collectively with patients, healthcare providers, policymakers, and other stakeholders. This endeavor is neither simple nor easy given the many challenges that exist in the effective translation of research discoveries into effective and widely utilized public health strategies. Nevertheless, opportunities exist for developing partnerships across biomedical and behavioral arenas to facilitate the translation of research discoveries into health. One area of opportunity involves the dissemination and use of frameworks such as the ORBIT model to guide behavioral intervention development. The ORBIT model exemplifies a cross-disciplinary approach in which clinical and public health needs are used to direct the research questions being asked at the outset of the translational process and the interventions being developed to target clinically significant changes in health behaviors, thus maximizing the potential of behavioral treatments to affect health outcomes. For early-phase behavioral translation, more integration of cross-disciplinary teams across both behavioral and biomedical arenas is needed, ideally involving programs of research that bring together basic behavioral and social scientists with applied behavioral researchers as well as with clinical researchers, practitioners and public health scientists to solve specific problems related to clinical and public health practice. Also helpful are workshops and conferences that bring different disciplines together and enable exchanges of methods, approaches, and problem-solving techniques across areas of expertise. These efforts can be greatly accelerated through the development of training and methods development, funding mechanisms and review groups that are targeted to early-phase behavioral science translation so that the appropriate expertise to support and review such programs is available, leading to greater recognition and sustainability of this area of translation. For late-phase behavioral translation, the formation of partnerships across Federal agencies in both the health and nonhealth sectors as well as with private sector entities and nongovernmental organizations to leverage support for late-phase research is crucial. It will also be important to develop research training and career development pathways to address current and future workforce needs. In addition, attention to methodological rigor, development of appropriate metrics, and models to enable broader knowledge, greater acceptance, and reach within both the biomedical and behavioral communities is essential for full realization of the benefits of advancements in both biomedical and behavioral preventive and therapeutic strategies. Acknowledgments The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; National Cancer Institute; National Institutes of Health; or the United States Department of Health and Human Services. The authors disclose that the findings and views expressed in this article have not been previously published and that the manuscript is not being simultaneously submitted elsewhere. In addition, the contents have not been previously published. 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Journal

Translational Behavioral MedicineOxford University Press

Published: Mar 29, 2018

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