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Development and preliminary validation of the Sjögren’s Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren’s syndrome
Step 3: evaluation of sensitivity to change of STAR options and selection of the candidate STAR This phase aimed at selecting the candidate STAR and relied on analysis of nine RCTs completed at the time of analysis (table 1). Analysis of sensitivity to change of STAR options The responder rate in each group for binary options (or the mean score for continuous options) was calculated for each STAR option in each RCT.
Development and preliminary validation of the Sjögren’s Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren’s syndrome
Methods The development and preliminary retrospective validation of STAR followed the OMERACT (Outcome Measures in Rheumatology) guidelines14 and consisted of three steps (figure 1), combining data-driven methods from nine RCTs (table 1) and consensus methods. The Delphi panel was formed by 78 pSS international experts (57 clinicians, 21 scientists) and 20 patients with pSS (online supplemental 1).
Development and preliminary validation of the Sjögren’s Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren’s syndrome
Development and preliminary validation of the Sjögren’s Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren’s syndrome http://orcid.org/0000-0002-5523-1856Raphaele Seror1,2, Gabriel Baron3,4, Marine Camus1,2, http://orcid.org/0000-0002-9159-702XDivi Cornec5,6, Elodie Perrodeau3,4, Simon J Bowman7,8,9, Michele Bombardieri10, Hendrika Bootsma11, http://orcid.org/0000-0002-9469-946XJacques-Eric Gottenberg12,13,...
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