| Abstrakt: |
Background: Systemic lupus erythematosus (SLE) is associated with clinical burden for the patient and organ damage. The development of therapies for SLE has been constrained by clinical and biologic heterogeneity. These represent challenges in clinical trial design and endpoint selection. Objective: To identify the most relevant descriptors for efficacy, endpoints, disease activity, organ damage, quality of life (QoL), and Patient Reported Outcome Measures (PROMs) in the treatment of SLE. Methods: A Delphi study was conducted using a national expert panel of clinicians in the treatment of SLE. A steering committee composed of 3 opinion leaders with deep expertise in SLE treatment was defined. The steering committee analyzed and appraised the evidence, designed the Delphi study, defined the statements, and analyzed the expert panel responses. A 2-round Delphi survey was conducted. Participants were asked to rate the statements using a five-point Likert scale. Results: Nine experts participated in the Delphi survey. After the two rounds, the consensus was reached on 18 of the 23 statements: 2 statements were included in the "efficacy" domain, 2 in the "glucocorticoid-sparing" domain, 2 in the "endpoint evaluation" domain, 4 in the "score" domain, 1 in the "disease activity" domain, 1 in the "organ damage" domain, 1 in the "QoL" domain, 2 in the "PROMs" domain, 1 in the "AIFA monitoring" domain and 2 in the "extra" domain. No statements reached consensus within the "onset" domain. Conclusion: In this Delphi study, 18 statements across 11 domains were agreed upon for the treatment of SLE. [ABSTRACT FROM AUTHOR] |
