Center for Translation Research and Implementation Science

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 populations 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 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 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