Fig. 2: Conceptual framework for TRM-SLE. | Nature Reviews Rheumatology

Fig. 2: Conceptual framework for TRM-SLE.

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

Fig. 2

Illustration of the conceptual framework that will be established using the proposed methods for development of the treatment response measure for systemic lupus erythematosus (TRM-SLE) instrument. As recommended by regulatory guidance, this framework includes the concepts of interest (including domain-level and item-level concepts) targeted for assessment and how these relate to the patient experience, along with consideration of how the concepts will be measured and scored. In this figure, italic text represent theoretical examples; the specific elements that will fill the framework will be determined by the completion of Stages 1.3–1.5.

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