- Study design (cross-sectional, cohort studies; placebo controlled, randomized, double-blind; prospective or retrospective; investigational or non-investigational, observational studies)
- Inclusion and exclusion criteria
- End points (GMTs, increase of titers, protective titers)
- Heterogeneity of compared groups (healthy controls or RA patients)
- Heterogeneity in vaccine preparations (adjuvanted or non-adjuvanted; polysaccharide or conjugated; containing antigens)
- Timing of vaccination
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- Health state
- Disease course
- Severity of disease
- Co-morbidities
- Age
- Gender and hormonal changes
- Life-style factors (e. g. smoking, alcohol)
- Heterogeneity in use of immunotherapies
- Duration of immunotherapies
- Heterogeneity in use of conventional DMARDs and glucocorticoids
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- Time point of antibody assessment
- Pre-vaccination titers
- Assays used (sensitivity and specificity)
- Specificity of antigens used in assays
- Definition of response and protection
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