Development and preliminary validation of the Sjogren's Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjogren's syndrome.

ABSTRACT:

Objective

To develop a composite responder index in primary Sjögren's syndrome (pSS): the Sjögren's Tool for Assessing Response (STAR).

Methods

To develop STAR, the NECESSITY (New clinical endpoints in primary Sjögren's syndrome: an interventional trial based on stratifying patients) consortium used data-driven methods based on nine randomised controlled trials (RCTs) and consensus techniques involving 78 experts and 20 patients. Based on reanalysis of rituximab trials and the literature, the Delphi panel identified a core set of domains with their respective outcome measures. STAR options combining these domains were proposed to the panel for selection and improvement. For each STAR option, sensitivity to change was estimated by the C-index in nine RCTs. Delphi rounds were

SUBMITTER: Seror R 

PROVIDER: S-EPMC9209686 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature