This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research
Quality and Methodology of Clinical Practice Guidelines on Antiviral Pharmacotherapy for COVID-19 During the Early Phase of the Pandemic
Filip Mejza
Evidence Based Medicine Unit, Jagiellonian University Medical College
Corresponding Author
ORCiD: https://orcid.org/0000-0002-5615-5867
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Despite availability of reliable guidelines development methods, the risk of producing less reliable documents may be higher when the guidelines are developed rapidly and high-quality evidence is lacking. The aim of this study was to assess the ways in which such documents, dealing with antiviral therapy, were developed in the early stages of COVID-19 pandemic and assess if recommendations were supported by evidence.
Methods
We performed the search for guidelines or similar documents, published before the results of any randomized controlled trials of COVID-19 treatment were available, that considered antiviral therapies and contained a recommendations for clinicians. The quality of the guidelines was assessed using the AGREE II-Global Rating Scale Instrument and series of dichotomous criteria based on the domain 3 of the AGREE II tool. We analyzed variables associated with the presence of recommendations, including strong ones, for antiviral therapy for SARS-CoV-2.
Results
The analysis included 40 publications, of which we classified 17 as clinical practice guidelines and 23 – as guidance or statements. The median of quality of documents assessed with the AGREE II-GRS tool (overall quality assessment on a scale ranging from 1-7) was 2.0 (IQR 1.5–2.5). Most documents did not fulfill the rigour of guideline development quality criteria. The AGREE II-GRS scores did not differ significantly across the type of the document, issuing institution and the mode of publication. Overall, 62.5% of documents provided recommendations for the use of antiviral medications despite apparent lack of sufficient evidence supporting such treatments. Documents that contained recommendations supporting antiviral drug use tended to be of lower quality than those without such recommendations. Of the included documents, 75% were not updated within the 2 months after the publication of the first randomized controlled trial on COVID-19 antiviral therapy.
Conclusions
Most guidelines or guidance documents published during the early phase of the COVID-19 pandemic were of poor quality, contained recommendations for the use of antiviral therapy for SARS-CoV-2 infection despite only very low quality of evidence available, and were not updated on a regular basis. This information may be of value during this or future pandemics.
Keywords
guidelines, quality, COVID-19, AGREE II, GRADE
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
- MejzaAdditionalfile1Searchstrategy.docx
Additional file 1 – Search strategy
- MejzaAdditionalFile2DocumentsSelectionFlowchart.jpg
Additional file 2 – Document selection flowchart
- MejzaAdditionalfile3Dataextracted.docx
Additional file 3 – Data extracted
- MejzaAdditionalfile4Listofincludeddocuments.docx
Additional file 4 – List of included documents
- MejzaAdditionalfile5AGREEIIGRSScores.docx
Additional file 5 – AGREE II GRS Scores of included documents
- MejzaAdditionalfile6Qualitycharacteristics.docx
Additional file 6 – Detailed quality characteristics of included documents
- MejzaAdditionalfile7PRISMA.doc
Additional file 7 – PRISMA Checklist
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 29 Dec, 2020
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Clinical Pharmacology
Learn more about our company.
This is a preprint. It has not completed peer review.
Research
Quality and Methodology of Clinical Practice Guidelines on Antiviral Pharmacotherapy for COVID-19 During the Early Phase of the Pandemic
Filip Mejza
Evidence Based Medicine Unit, Jagiellonian University Medical College
Corresponding Author
ORCiD: https://orcid.org/0000-0002-5615-5867
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 29 Dec, 2020
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Clinical Pharmacology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Despite availability of reliable guidelines development methods, the risk of producing less reliable documents may be higher when the guidelines are developed rapidly and high-quality evidence is lacking. The aim of this study was to assess the ways in which such documents, dealing with antiviral therapy, were developed in the early stages of COVID-19 pandemic and assess if recommendations were supported by evidence.
Methods
We performed the search for guidelines or similar documents, published before the results of any randomized controlled trials of COVID-19 treatment were available, that considered antiviral therapies and contained a recommendations for clinicians. The quality of the guidelines was assessed using the AGREE II-Global Rating Scale Instrument and series of dichotomous criteria based on the domain 3 of the AGREE II tool. We analyzed variables associated with the presence of recommendations, including strong ones, for antiviral therapy for SARS-CoV-2.
Results
The analysis included 40 publications, of which we classified 17 as clinical practice guidelines and 23 – as guidance or statements. The median of quality of documents assessed with the AGREE II-GRS tool (overall quality assessment on a scale ranging from 1-7) was 2.0 (IQR 1.5–2.5). Most documents did not fulfill the rigour of guideline development quality criteria. The AGREE II-GRS scores did not differ significantly across the type of the document, issuing institution and the mode of publication. Overall, 62.5% of documents provided recommendations for the use of antiviral medications despite apparent lack of sufficient evidence supporting such treatments. Documents that contained recommendations supporting antiviral drug use tended to be of lower quality than those without such recommendations. Of the included documents, 75% were not updated within the 2 months after the publication of the first randomized controlled trial on COVID-19 antiviral therapy.
Conclusions
Most guidelines or guidance documents published during the early phase of the COVID-19 pandemic were of poor quality, contained recommendations for the use of antiviral therapy for SARS-CoV-2 infection despite only very low quality of evidence available, and were not updated on a regular basis. This information may be of value during this or future pandemics.
Figure 1
Figure 2