Fig. 1: Steps in the development and validation of a novel treatment response measure for SLE. | Nature Reviews Rheumatology

Fig. 1: Steps in the development and validation of a novel treatment response measure for SLE.

From: Towards a novel clinical outcome assessment for systemic lupus erythematosus: first outcomes of an international taskforce

Fig. 1

a, Stage 1 (instrument development) in the definition of a novel clinical outcome assessment via expert consensus informed by available data comprises five sub-stages that will lead to an operational, multi-domain, clinical outcome assessment that defines treatment response at both a global and a domain-specific level. The outcomes of Stages 1.1–1.2, and consensus methods agreed upon by the taskforce for Stages 1.3–1.5, are described in this Consensus Statement. b, The provisional instrument will be validated in trial datasets (Stage 2) as well as concurrently undergoing additional testing of its measurement properties (Stage 3). Key measurement properties that will be evaluated include construct validity, reliability, ability to detect change, discrimination of treatment effects, interpretability and feasibility.

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