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Struct Heart
Struct Heart
Structural Heart
2474-8706
2474-8714
Elsevier

S2474-8706(24)00114-3
10.1016/j.shj.2024.100359
100359
Editor's Page
Implementation: The Final Step in Translating Innovation
DeMaria Anthony MD ademaria@health.ucsd.edu
∗
Judy and Jack White Chair in Cardiology, Sulpizio Cardiovascular Center, University of California, San Diego, La Jolla, California
∗ Address correspondence to: Anthony DeMaria, MD, Division of Cardiology, UC San Diego, 9300 Campus Point Drive, MC 7411, La Jolla, CA 92037. ademaria@health.ucsd.edu
29 8 2024
9 2024
29 8 2024
8 5 100359© 2024 Published by Elsevier Inc. on behalf of Cardiovascular Research Foundation.
2024

https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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pmcIn 1747, the British Navy conducted the first randomized trial that documented that citrus fruits successfully treated scurvy. Nevertheless, it was nearly 50 more years until the navy routinely implemented citrus to prevent scurvy.1 In many respects, the implementation of effective medical drugs and procedures has not improved much since that time. In fact, the medical literature is replete with instances of lack of implementation of therapies documented to be effective.

Limitations in the translation of important innovations to patients have been particularly prominent for cardiovascular diseases. Several studies have documented the low utilization of high intensity statin therapy even in patients with acute coronary syndromes.2 The application of foundational guideline-directed medical therapy for heart failure was found to be woefully infrequent in patients with heart failure.3 Even such fundamental therapies as the treatment to goal of hypertension has been lacking in a high percentage of patients.4 In the area of structural heart disease either surgical or transcatheter intervention in symptomatic patients with aortic stenosis has been applied in only a small percent of patients, even in prestigious academic institutions.5 Clearly, a substantial gap exists between the availability of medical innovations and the delivery to patients who could benefit.

Considerable attention has recently been focused on the delay in the translation of important medical innovations to the bedside. It has been estimated that to succeed in implementing a new discovery requires 15 to 20 years and billions of dollars. The process of translation is usually described as including the concept, preclinical and clinical testing, regulatory and reimbursement approval, and ultimately inclusion in the guidelines. However, it is becoming abundantly clear that the final crucial step in the pathway should be implementation. As stated simply, the medicine does not work if the patient does not take it.

The foregoing has led to the development and appreciation of implementation science. In large part, implementation science is based on the concept that the adoption of new innovations is a social process involving multiple variables above and beyond the scientific evidence that establishes efficacy. It emphasizes the context in which the innovation is applied. It has been defined in a variety of ways. The National Institutes of Health/ National Cancer Institute has defined “Implementation science as the study of methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine health care and public health settings to improve the impact on population health.” Stated simply, implementation science is the discipline that identifies the optimal methods to get new innovations to the patients that would benefit. As evidence of the increasing recognition and importance of this field, the National Institutes of Health has made implementation and dissemination research a priority and established an Implementation Branch for heart, lung, blood, and sleep disorders.

Implementation science is distinct from several other related investigative endeavors.1 Clinical efficacy and effectiveness research aims to establish the benefit of novel procedures, while implementation research seeks to define tactics to achieve the adoption and maintenance of innovations. Similarly, implementation science differs from quality improvement efforts that usually focus on a specific issue in a specific group of providers. While dissemination research is a closely related discipline, its goal is to distribute knowledge and information rather than to directly influence behavior. Given the goals of implementation science, the targets involve physicians, administrators, and even patients. Given the social, environmental, and economic variables that can affect adoption, not surprisingly, implementation science involves social scientists, economists, government workers, and other nonclinicians.

The long delay and limited diffusion of important medical innovations has received great recent attention as an important problem. Primary consideration has thus far been focused upon the investigative and regulatory pathways by which innovations are made available. Substantial efforts are now being directed to these areas. However, even when these pathways are finally negotiated, evidence exists that there is often delayed and/or incomplete implementation. As a clinical investigator, I have (inaccurately) always believed that the documentation of efficacy and effectiveness was all that was needed for a novel diagnostic or therapeutic procedure to be adopted. I inappropriately assumed that when confronted with evidence that innovations were of benefit, they would rapidly be implemented into practice. Surely the final step of including innovations in guideline documents would ensure uptake. Clearly, there exist important social, environmental, economic, and personal variables that influence the adoption of validated new procedures. These variables are being recognized, and considerable momentum has been building to overcome them. Among other things, this has led to the spawning of and emphasis upon implementation research. This emphasis is probably long overdue. In the future, when discussing important issues regarding the translation of innovations to the treatment of patients, I believe that the importance of implementation should receive appropriate stress.

Funding

The author has no funding to report.

Disclosure Statement

The author reports no conflict of interest.
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References

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