A protocol for retrospective translational science case studies of health interventions

Abstract

The critical processes driving successful research translation remain understudied. We describe a mixed-method case study protocol for analyzing translational research that has led to the successful development and implementation of innovative health interventions. An overarching goal of these case studies is to describe systematically the chain of events between basic, fundamental scientific discoveries and the adoption of evidence-based health applications, including description of varied, long-term impacts. The case study approach isolates many of the key factors that enable the successful translation of research into practice and provides compelling evidence connecting the intervention to measurable changes in health and medical practice, public health outcomes, and other broader societal impacts. The goal of disseminating this protocol is to systematize a rigorous approach, which can enhance reproducibility, promote the development of a large collection of comparable studies, and enable cross-case analyses. This approach, an application of the “science of translational science,” will lead to a better understanding of key research process markers, timelines, and potential points of leverage for intervention that may help facilitate decisions, processes, and policies to speed the sustainable translational process. Case studies are effective communication vehicles to demonstrate both accountability and the impacts of the public’s investment in research.

A retrospective case study of successful translational research: Gazelle Hb variant point-of-care diagnostic device for sickle cell disease

“…This translational science case study was developed from interviews of individuals involved with the research as well as background research on the science. The format for reporting this case study was based on a protocol for conducting case studies of successful translational science 1 . The interviewees may have subjective viewpoints, and so an attempt was made to interview multiple individuals to arrive at a more accurate understanding of the case.…”

“…Case studies of translational science are used to examine elements that advance science and improve public health outcomes. Recently, a standardized protocol for conducting retrospective case studies to evaluate the translational research processes was published 1 .…”

Teaching principles of translational science to a broad scientific audience using a case study approach: A pilot course from the National Center for Advancing Translational Sciences

“…These activities could leverage the research strengths of one organization, or the collective strength of multiple organizations, to develop case studies or utilize other case studybased resources (e.g., publications, training exercises) to share experiential knowledge in translational science. Case studies focused on successful projects that ultimately produce valuable population health benefits are of increasing interest for demonstrating the impact of research investment [27]. Yet, these case studies and others with more proximal outcomes could also be leveraged for educational purposes.…”

Adapting an Expanded Access program to enable investigational treatments for COVID-19

“…This case study demonstrates how MICHR's EA program contributed to mitigating the impact of the COVID-19 pandemic in the fall of 2020. A multi-site SMARTIRB was obtained (IRB-2017-2018 CR00004870) by six CTSA hubs using a common case study protocol [1]. Staff members provided background and basic information about the program, in addition to a list of potential interview subjects.…”

“…This retrospective case study regards one EA program administered by MICHR, a Clinical and Translational Research Award (CTSA) institute funded by the National Institutes of Health (NIH) to advance clinical and translational science. A protocol for translational science case studies was followed to enable cross-case analysis of the barriers and facilitators of translational processes [1,2]. The results demonstrate how health care and research teams at U-M adapted the operations of the EA program in ways that were sustainable, collaborative, equitable, flexible, managed for effective and efficient performance, and proportionate to relevant risks [3][4][5][6].…”