ABSTRACT
Abstract
Objective:
To provide guidelines on the coronavirus disease 2019 (COVID-19)
vaccination in
patients with immune-mediated
rheumatic diseases (IMRD) to
rheumatologists considering specific scenarios of the daily practice based on the
shared-making
decision (SMD) process.
Methods:
A
task force was constituted by 24
rheumatologists (panel members), with clinical and
research expertise in
immunizations and
infectious diseases in
immunocompromised patients, endorsed by the Brazilian Society of
Rheumatology (BSR), to develop guidelines for COVID-19
vaccination in
patients with IMRD. A
consensus was built through the
Delphi method and involved four rounds of anonymous
voting, where five options were used to determine the level of agreement (
LOA), based on the Likert Scale (1) strongly disagree; (2) disagree, (3) neither agree nor disagree (neutral); (4) agree; and (5) strongly agree. Nineteen questions were addressed and discussed via
teleconference to formulate the answers. In order to identify the relevant data on
COVID-19 vaccines, a search with standardized
descriptors and synonyms was performed on September 10th, 2021, of the
MEDLINE, EMBASE, Cochrane Central
Register of Controlled Trials, ClinicalTrials.gov, and
LILACS to identify studies of interest. We used the Newcastle-Ottawa Scale to assess the quality of nonrandomized studies.
Results:
All the nineteen questions-answers (Q&A) were approved by the BSR
Task Force with more than 80% of panelists
voting options 4—agree—and 5—strongly agree—, and a
consensus was reached. These Guidelines were focused in SMD on the most appropriate timing for IMRD
patients to get vaccinated to reach the adequate covid-19
vaccination response.
Conclusion:
These guidelines were developed by a BSR
Task Force with a high
LOA among panelists, based on the
literature review of published studies and
expert opinion for COVID-19
vaccination in IMRD
patients. Noteworthy, in the
pandemic period, up to the
time of the
review and the
consensus process for this
document, high-quality evidence was scarce. Thus, it is not a substitute for clinical
judgment.