Center for Translation Research and Implementation Science
The Center for Translation Research and Implementation Science (CTRIS) plans, fosters, and supports research to identify the best strategies for ensuring successful integration of evidence-based interventions within clinical and public health settings, such as health centers, worksites, communities, and schools in the United States and abroad. These strategies will build on the successes in fundamental discovery science and early-stage translational research. They also will help tackle new challenges in late-stage T4 translational research—the phase in the translational research pathway that leads to general knowledge about implementing evidence-based interventions—that helps turn discoveries into improved health.
CTRIS was established in 2014 to serve as the strategic focal point within NHLBI for advancing:
- late-stage T4 translation research for heart, lung, blood, and sleep disorders in real-world settings;
- implementation science with emphasis on the development, adoption, and implementation of clinical practice guidelines based on rigorous systematic evidence reviews and crucial collaborations with partner organizations and agencies;
- health inequities implementation research;
- global health implementation research; and
- research training and career development in the above areas.
The overarching theme that underpins the CTRIS mission is the need to ensure maximum return on NHLBI investments in research and research training, and the NHLBI Strategic Vision guides in that effort. Other important cross-cutting priorities include developing strategic partnerships to accomplish the NHLBI mission and developing research capacity for implementation research, especially in low- and middle-income countries and in low-resource settings in high-income countries. CTRIS works closely with NHLBI Divisions supporting research training and career development in fields related to its core mission.
Successful execution of T4 translation research requires transdisciplinary collaborations of diverse stakeholders across various sectors. New, innovative platforms solicit, nurture, and support team science to promote synergy among diverse professionals from biomedical, behavioral, and social science research, as well as experts from engineering, bioinformatics, behavioral economics, and the emerging field of big data science. Strategic partnerships also engage partners from public and private sectors, and leverage stakeholders central to implementation science, precision medicine, and the learning health care system.
Accelerating the Translation and Implementation of Genomics and Precision Medicine
CTRIS, in collaboration with NHLBI Divisions, other NIH Institutes, and the CDC Office of Public Health Genomics, is developing a research framework for accelerating the translation and implementation of genomics and precision medicine to reduce the burden of heart, lung, blood, and sleep disorders. CTRIS is actively engaged in NHLBI’s Trans-Omics for Precision Medicine (TOPMed) Program to help advance dissemination and implementation research in alignment with the Institute’s precision health activities and the NIH All of Us Research Program. Specifically, CTRIS is developing these resources, processes, and tools:
A knowledge integration process to synthesize results of basic, clinical, and population science research discoveries to identify promising genomics and precision medicine applications
- A robust implementation science research agenda for clinically effective genomic and precision medicine applications
- Learning health systems approaches to accelerate the identification, evaluation, and implementation of promising genomics and precision medicine applications
- Approaches to leverage existing large scale clinical cohorts of diverse popultaions to accelerate the evaluation, implementation, and impact of genomics and precision medicine
- Training, tools, resources, and partnerships in implementation science for researchers and practitioners to accelerate the population impact of genomics and precision medicine
- Approaches to explore the ethical, legal, and social implications of implementation research, risk communication, and the return of results in genomics and -omics research
Mixed Methods to Address Gaps in Our Understanding of How to Disseminate and Implement Evidence
Mixed methods research is a methodology in the social and behavioral sciences that emerged because of a need to provide various perspectives on answers to questions, the goal being to reduce or eliminate information gaps and asymmetry and minimize the impact of pre-existing assumptions. Mixed methods—also known as multi-methods—involve the integration of quantitative and qualitative data collection and analytical approaches into a single study or program of inquiry to generate new knowledge. It can include either concurrent or sequential use of these two classes of methods to follow a line of inquiry. This combined use of qualitative and quantitative research is believed to improve our understanding of the issue under investigation in many ways, such as by helping us overcome discrete weakness and following questions that emerge.
Pragmatic Trials to Generate Evidence that is More Generalizable and Applicable to Real-World Settings
Pragmatic trials constitute a cornerstone of late-stage T4 translation research process. They are unlike explanatory trials that confirm a physiological or clinical hypothesis and form the pillars of the earlier stages of the translational research spectrum. Rather, pragmatic trials are designed to inform clinical or policy decisions by generating the knowledge needed for the adoption of interventions, already proven to be effective in explanatory trials, into real-world clinical practice and community settings.
To inform clinical practice, CTRIS supports the inclusion of pragmatic elements in trials to the maximum extent possible without negatively impacting the integrity of the study design. There are some of the assessment criteria for pragmatic trials that have been described in literature:
- Eligibility: the extent that the participants in the trial are similar to patients who would receive the study’s intervention if the intervention was part of usual care
- Recruitment: whether the level of effort required to recruit participants is more than the level of engagement with patients in a usual clinical care setting
- Setting: if and how the study setting differs from the setting found with usual care
- Organization: if and how the resources, provider expertise, and organization of care delivery in the intervention group of the study differ from those available in usual care
- Flexibility in delivery: if and how the flexibility in intervention delivery differs from the flexibility anticipated in usual care
- Flexibility in adherence: if and how the flexibility in participant monitoring and encouragement to adhere with the intervention differ from the flexibility anticipated in usual care
- Follow-up: if and how the intensity of measurement and follow-up care of study differs from the typical intensity in usual care
- Primary outcome: the extent that the primary outcome of the study is directly relevant to participants
- Primary analysis: the extent that all data are included in the analysis of the primary outcome
What We Do
The Health Inequities and Global Health (HIGH) Branch is the NHLBI’s main source for guidance pertaining to domestic and global health inequities implementation research. This includes identifying research gaps and needs, as well as research opportunities to address them. The HIGH Branch also serves as the NHLBI focal point for advice and guidance on research on global health and the study of implementation strategies for interventions that have been proven effective around the world. The HIGH Branch supports T4 translation research and implementation science directed at strategies to reduce or eliminate both domestic and global health disparities in heart, lung, blood, and sleep disorders.
- LeShawndra N. Price
- Branch Chief
The Implementation Science Branch (ISB) supports integrated research programs to explore the contributing factors to the successful implementation and scale-up of evidence-based interventions in clinical and public health settings such as clinics, worksites, and communities. The ISB programs seek to speed the progression from discovery to widespread implementation by harnessing effective dissemination strategies, identifying and encouraging exploration of knowledge gaps, and promoting validated research frameworks, delivery and implementation strategies for proven effective interventions in real-world practice and community settings. Primary implementation research outcomes include acceptability, affordability, appropriateness, cost, feasibility, fidelity, penetration, and sustainability of interventions for heart, lung, blood, and sleep disorders and their comorbidities. The ISB supports the development, adoption, and implementation of evidence-based clinical practice guidelines based on rigorous systematic evidence reviews, and collaborations with institutions, organizations and agencies required to achieve these objectives.
- Cheryl Anne Boyce
- Branch Chief
The Translation Research Branch (TRB) supports late-stage T4 translation research with a focus on community and population-based analyses of proven-effective interventions. The TRB advances research that focuses on implementation research outcomes such as adaptation, adoption, affordability, fidelity, and sustainability. The TRB encourages crosscutting analyses that combine patient-centered, community-based data with population-level data for more robust results. Additionally, the TRB identifies methodology innovations such as mixed methods study designs and relatively inexpensive pragmatic trials to inform and improve the translation of discovery science into health impact.
- Michael M. Engelgau
- M.D., M.S.
Office of the Director
The Office of the Director at CTRIS provides overall planning, direction, coordination, and evaluation of the Center’s programs, as well as strategic coordination of all late-stage T4 translation research and implementation science across NHLBI. The Office oversees development and management of a robust portfolio of T4 translation research and implementation science; scientific workshops and educational programs for investigators and trainees; CTRIS staff professional development; collaborations and partnerships across NHLBI, NIH, other federal health agencies, academia, and global institutions; and facilitates efforts to assess and disseminate health information to the scientific community and the public. Finally, this Office serves as the hub for all NHLBI Strategic Vision milestones in late-stage T4 translation research and implementation science.