Paranilam Jaya, Arcioni Francesco, Franco Antonio, Lai Kira Zhi Hua, Brown Joseph, Kimball-Carroll Samantha
ICON Clinical Research, Dublin 18, Ireland.
Pediatric Onco-Hematology with Bone Marrow Transplantation, Azienda Ospedaliera Di Perugia, Piazza Menghini 1, 06132, Perugia, Italy.
Infect Dis Ther. 2024 Nov;13(11):2227-2253. doi: 10.1007/s40121-024-01051-9. Epub 2024 Oct 9.
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.
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.
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.
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.
2019年冠状病毒病（COVID-19）大流行给全球医疗系统带来了前所未有的压力。在风湿性疾病、肾脏疾病、血液系统恶性肿瘤以及实体器官移植受者的COVID-19管理方面，缺乏高质量指南导致临床实践存在很大差异。
通过德尔菲法，由16位关键意见领袖组成的小组制定了关于在标准缺失或有限领域的疫苗建议的临床实践声明。还通过在线医生调查评估了执业医生对共识声明的认同情况。共识强度由以下评级系统确定：强评级定义为所有四位关键意见领袖（KOL）对声明的评分≥8；中等评级定义为四位KOL中有三位对声明的评分≥8；无共识定义为四位KOL中少于三位给出的评分≤8。专家们使用相同的十分制评分系统对其疾病领域内的每项共识声明的认同情况进行投票。
风湿病、肾脏病和血液学领域的关键意见领袖对与初次和加强系列相关的所有九条声明达成了共识，移植医生对九条声明中的八条达成了共识。专家们一致认为，COVID-19疫苗对患有风湿性疾病、肾脏疾病、血液系统恶性肿瘤的患者以及实体器官移植受者是安全、有效的，且耐受性良好。德尔菲法对COVID-19信使核糖核酸（mRNA）疫苗的使用以及免疫功能低下人群接种COVID-19加强针的必要性给出了强烈到中等程度的建议。专家小组对抗体滴度的测量、高剂量mRNA疫苗以及针对特定疾病的COVID-19指南的制定看法不一。
这些结果证实了COVID-19疫苗和加强针对于患有风湿性疾病、肾脏疾病、血液系统恶性肿瘤的免疫功能低下患者以及实体器官移植受者的必要性。未达成共识的声明是由于证据缺失或有限。
