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Delphi Panel Consensus Statement Generation: COVID-19 Vaccination Recommendations for Immunocompromised Populations
Jaya Paranilam1, Francesco Arcioni2, Antonio Franco3
1ICON Clinical Research, Dublin 18, Ireland.
Insights
COVID-19 vaccines and boosters are recommended for immunocompromised patients with rheumatologic, renal, hematologic, or transplant conditions. Experts reached consensus on vaccine safety and efficacy, emphasizing the need for boosters in this vulnerable population.
Area of Science:
- Immunology
- Vaccinology
- Clinical Practice Guidelines
Background:
- The COVID-19 pandemic strained global healthcare systems.
- Lack of clear guidelines for managing COVID-19 in specific patient groups (rheumatologic, renal, hematologic, transplant) led to varied practices.
Purpose of the Study:
- To develop clinical practice statements on COVID-19 vaccine recommendations for immunocompromised patients.
- To assess practicing physicians' agreement with these consensus statements.
Main Methods:
- A Delphi process involving 16 key opinion leaders (KOLs) to create practice statements.
- An online physician survey to evaluate agreement with consensus statements.
- A rating system to determine the strength of consensus among KOLs.
Main Results:
- Consensus was achieved on most vaccine recommendations for rheumatology, nephrology, hematology, and transplant patients.
- Experts confirmed COVID-19 vaccines are safe, effective, and well-tolerated in these populations.
- Strong to moderate suggestions support mRNA vaccines and boosters for the immunocompromised.
Conclusions:
- COVID-19 vaccines and boosters are necessary for immunocompromised patients across various conditions.
- Areas lacking consensus were attributed to limited or absent evidence, highlighting the need for further research.
Introduction:
The coronavirus disease 2019 (COVID-19) pandemic has caused unprecedented pressure on healthcare systems globally. The lack of quality guidelines on the management of COVID-19 in rheumatologic disease, renal disease, hematological malignancy, and solid organ transplant recipients has resulted in a wide variation in clinical practice.
Methods:
Using a Delphi process, a panel of 16 key opinion leaders developed clinical practice statements regarding vaccine recommendations in areas where standards are absent or limited. Agreement among practicing physicians with consensus statements was also assessed via an online physician survey. The strength of the consensus was determined by the following rating system: a strong rating was defined as all four key opinion leaders (KOLs) rating the statement ≥ 8, a moderate rating was defined as three out of four KOLs rating the statement ≥ 8, and no consensus was defined as less than three out of four KOLs provided a rating of ≤ 8. Specialists voted on agreement with each consensus statement for their disease area using the same ten-point scoring system.
Results:
Key opinion leaders in rheumatology, nephrology, and hematology achieved consensuses for all nine statements pertaining to the primary and booster series with transplant physicians reaching consensus on eight of nine statements. Experts agreed that COVID-19 vaccines are safe, effective, and well tolerated by patients with rheumatological conditions, renal disease, hematologic malignancy, and recipients of solid organ transplants. The Delphi process yielded strong to moderate suggestions for the use of COVID-19 messenger ribonucleic acid (mRNA) vaccines and the necessity of the COVID-19 booster for the immunocompromised population. The expert panel had mixed feelings concerning the measurement of antibody titers, higher-dose mRNA vaccines, and the development of disease-specific COVID-19 guidance.
Conclusions:
These results confirmed the necessity of COVID-19 vaccines and boosters in immunocompromised patients with rheumatologic disease, renal disease, hematological malignancy, and solid organ transplant recipients. Statements where consensus was not achieved were due to absent or limited evidence.
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