for the French Study Group on Autoimmune Bullous Skin Diseases IMPORTANCE Rituximab and short-term corticosteroid therapy are the criterion standard treatments for patients with newly diagnosed moderate to severe pemphigus. OBJECTIVE To examine factors associated with short-term relapse in patients with pemphigus treated with rituximab. DESIGN, SETTING, AND PARTICIPANTS This post hoc analysis of a randomized clinical trial (Comparison Between Rituximab Treatment and Oral Corticosteroid Treatment in Patients With Pemphigus [RITUX 3]) conducted from January 1, 2010, to December 31, 2015, included patients from 20 dermatology departments of tertiary care centers in France from the RITUX 3 trial and 3 newly diagnosed patients treated according to the trial protocol. Data analysis was performed from February 1 to June 30, 2019.EXPOSURE Patients randomly assigned to the rituximab group in the RITUX 3 trial and the 3 additional patients were treated with 1000 mg of intravenous rituximab on days 0 and 14 and 500 mg at months 12 and 18 combined with a short-term prednisone regimen.MAIN OUTCOMES AND MEASURES Baseline (pretreatment) clinical and biological characteristics (Pemphigus Disease Area Index [PDAI] score, ranging from 0-250 points, with higher values indicating more severe disease) and changes in anti-desmoglein (DSG) 1 and anti-DSG3 values as measured by enzyme-linked immunosorbent assay during the 3 months after rituximab treatment were compared between patients with disease relapse and those who maintained clinical remission during the first 12 months after treatment. The positive and negative predictive values of these factors were calculated. RESULTS Among 47 patients (mean [SD] age, 54.3 [17.0] years; 17 [36%] male and 30 [64%] female) included in the study, the mean (SD) baseline PDAI score for patients with relapsing disease was higher than that of the patients with nonrelapsing disease (54 [33] vs 28 [24]; P = .03). At month 3, 7 of 11 patients with relapsing disease (64%) vs 7 of 36 patients with nonrelapsing disease (19%) had persistent anti-DSG1 antibody values of 20 IU/mL or higher and/or anti-DSG3 antibody values of 130 IU/mL or higher (P = .01). A PDAI score of 45 or higher defining severe pemphigus and/or persistent anti-DSG1 antibody values of 20 IU/mL or higher and/or anti-DSG3 antibody values of 130 IU/mL or higher at month 3 provided a positive predictive value of 50% (95% CI, 27%-73%) and a negative predictive value of 94% (95% CI, 73%-100%) for the occurrence of relapse after rituximab. CONCLUSIONS AND RELEVANCEThe findings suggest that initial PDAI score and changes in anti-DSG antibody values after the initial cycle of rituximab might help differentiate a subgroup of patients with high risk of relapse who might benefit from maintenance rituximab infusion at month 6 from a subgroup of patients with low risk of relapse who do not need early maintenance therapy. TRIAL REGISTRATION NCT00784589
Background: Unstructured data from electronic health record is a gold mine. Doc’EDS is a pre-screening tool based on textual and semantic analysis. The system provides an easy-to-use interface to search documents in French. The aim of this study is to present the tools and to provide a formal evaluation of its semantic features. Material & Methods: Doc’EDS is a search tool built on the top of the clinical data warehouse developed in the Rouen University Hospital. This tool is a multilevel search engine combining structured and unstructured data. It also provides basic analytics features and semantic utilities. A formal evaluation has been conducted to measure the implemented Natural Language Processing algorithms. Results: About 17,3 million of narrative documents are contained in this CDW. The formal evaluation has been conducted over 5,000 clinical concepts that were manually collected. Negation concepts detection F-measure was 0.89, hypothesis concept detection F-measure was 0.57. Conclusion: We hereby present Doc’EDS, a semantic search tool which deals with language subtleties to enhance an advanced full text search engine dedicated to French health documents. This tool is currently used on a daily basis to help researchers identifying patients thanks to unstructured data.
Background Unstructured data from electronic health records represent a wealth of information. Doc’EDS is a pre-screening tool based on textual and semantic analysis. The Doc’EDS system provides a graphic user interface to search documents in French. The aim of this study was to present the Doc’EDS tool and to provide a formal evaluation of its semantic features. Methods Doc’EDS is a search tool built on top of the clinical data warehouse developed at Rouen University Hospital. This tool is a multilevel search engine combining structured and unstructured data. It also provides basic analytical features and semantic utilities. A formal evaluation was conducted to measure the impact of Natural Language Processing algorithms. Results Approximately 18.1 million narrative documents are stored in Doc’EDS. The formal evaluation was conducted in 5000 clinical concepts that were manually collected. The F-measures of negative concepts and hypothetical concepts were respectively 0.89 and 0.57. Conclusion In this formal evaluation, we have shown that Doc’EDS is able to deal with language subtleties to enhance an advanced full text search in French health documents. The Doc’EDS tool is currently used on a daily basis to help researchers to identify patient cohorts thanks to unstructured data.
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