METHODS AND ANALYSIS: At least 51 patients with an acute GPP flare will be randomised 2:1 to receive a single 900 mg intravenous dose of spesolimab or placebo and followed for up to 28 weeks. The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1. The key secondary endpoint is a GPPGA score of 0 or 1 (clear or almost clear) at Week 1. Safety will be assessed over the study duration by the occurrence of treatment-emergent adverse events. Blood and skin biopsies will be collected to assess biomarkers. Superiority of spesolimab over placebo in the proportion of patients achieving the primary and key secondary endpoints will be evaluated.
ETHICS AND DISSEMINATION: The study complies with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation's Good Clinical Practice and local regulations. Ethics committee approvals have been obtained for each centre from all participating countries and are listed in online supplementary file 1. Primary results will be published in a peer-reviewed journal.
TRIAL REGISTRATION DETAILS: ClinicalTrials.gov identifier: NCT03782792; Pre-results.
METHODS: We conducted a retrospective analysis of data collected in the Pan-Asian Resuscitation Outcomes Study (PAROS) registry. We included OHCA cases from seven communities (Japan, South Korea, Malaysia, Singapore, Taiwan, Thailand, and United Arab Emirates) between January 2009 and December 2012. Paediatric cases, cases that were conveyed by non-emergency medical services (EMS), and cases with incomplete records were excluded from the study.
RESULTS: The RACA score showed similar discrimination performance as the original German study and various European validation studies. However, it had poor calibration with the original constant regression coefficient, which was primarily due to the low ROSC rate (8.2%) in the PAROS cohort. The calibration performance of RACA significantly improved after the constant coefficient was modified to adjust for the disparity in ROSC rates between Asia and Europe.
CONCLUSION: This is the largest validation study of the RACA score. RACA consistently performs well in both Pan-Asian and European communities and can thus be a valuable tool for evaluating EMS systems. However, to implement it, the constant coefficient has to be modified in the RACA formula with local historical data.
METHODS: The translation of the UTBAS scales into Japanese (UTBAS-J) was completed using the standard forward-backward translation process, and was administered to 130 Japanese adults who stutter. To validate the UTBAS-J scales, scores for the Japanese and Australian cohorts were compared. Spearman correlations were conducted between the UTBAS-J and the Modified Erickson Communication Attitude scale (S-24), the self-assessment scale of speech (SA scale), and age. The test-retest reliability and internal consistency of the UTBAS-J were assessed. Independent t-tests were conducted to evaluate the differences in the UTBAS-J scales according to gender, speech treatment experience, and stuttering self-help group participation experience.
RESULTS: The UTBAS-J showed good test-retest reliability, high internal consistency, and moderate to high significant correlations with S-24 and SA scale. A weak correlation was found between the UTBAS-J scales with age. No significant relationships were found between UTBAS-J scores, gender and speech treatment experience. However, those who participated in the stuttering self-help group demonstrated lower UTBAS-J scores than those who did not.
CONCLUSION: Given the current scarcity of clinical assessment tools for adults who stutter in Japan, the UTBAS-J holds promise as an assessment tool and outcome measure for use in clinical and research environments.