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How Are Emerging Data Translated Into Clinical Practice? A Mixed Methods Investigation of Coronavirus Disease 2019
Archana Asundi1,2, Jack Resnik3,4, Peter A Benedict5
1Boston University School of Medicine, Boston, Massachusetts, USA.
Background:
Early in the coronavirus disease 2019 (COVID-19) pandemic, there was minimal data to guide treatment, and we lacked understanding of how clinicians translated this limited evidence base for potential therapeutics to bedside care. Our objective was to systematically determine how emerging data about COVID-19 treatments was implemented by analyzing institutional treatment protocols.
Methods:
Treatment protocols from North American healthcare facilities and recommendations from guideline-issuing bodies were collected. Qualitative data on treatment regimens and their applications were extracted using an adapted National Institutes of Health/US Food and Drug Administration experimental therapeutics framework. Structured data on risk factor and severity of illness scoring systems were extracted and analyzed using descriptive statistics.
Results:
We extracted data from 105 independent protocols. Guideline-issuing organizations published recommendations after the initial peak of the pandemic in many regions and generally recommended clinical trial referral, with limited additional guidance. Facility-specific protocols favored offering some treatment (96.8%, N = 92 of 95), most commonly, hydroxychloroquine (90.5%), followed by remdesivir and interleukin-6 inhibitors. Recommendation for clinical trial enrollment was limited largely to academic medical centers (19 of 52 vs 9 of 43 community/Veterans Affairs [VA]), which were more likely to have access to research studies. Other themes identified included urgent protocol development, plans for rapid updates, contradictory statements, and entirely missing sections, with section headings but no content other than "in process."
Conclusions:
In the COVID-19 pandemic, emerging information was rapidly implemented by institutions into clinical practice and, unlike recommendations from guideline-issuing bodies, heavily favored administering some form of therapy. Understanding how and why evidence is translated into clinical care is critical to improve processes for other emerging diseases.
Insights
Healthcare facilities rapidly implemented COVID-19 treatment protocols, often favoring therapies like hydroxychloroquine, even with limited evidence. This highlights the need to understand evidence translation for future pandemics.
Area of Science:
- Infectious Diseases
- Clinical Pharmacology
- Health Policy
Background:
- Limited early data guided COVID-19 treatment, creating uncertainty in clinical practice.
- Understanding the translation of emerging evidence to bedside care was crucial.
Purpose of the Study:
- To systematically analyze how institutional treatment protocols implemented emerging data on COVID-19 therapeutics.
- To compare institutional protocol development with guideline-issuing bodies' recommendations.
Main Methods:
- Collected and analyzed 105 North American healthcare facility treatment protocols and guideline recommendations.
- Utilized a framework to extract qualitative data on treatment regimens and quantitative data on risk/severity scoring.
- Employed descriptive statistics for data analysis.
Main Results:
- Facility protocols (96.8%) favored treatment, commonly hydroxychloroquine, remdesivir, and IL-6 inhibitors.
- Guideline bodies issued recommendations late, often suggesting clinical trial referral.
- Academic centers were more likely to recommend clinical trial enrollment compared to community/VA facilities.
Conclusions:
- Institutions rapidly translated emerging COVID-19 information into practice, often prioritizing therapy administration.
- Protocol development was urgent, with rapid updates, but sometimes contained contradictions or missing information.
- Improving evidence translation processes is critical for managing future emerging diseases.
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