Audrey de Parisot1, Laurent Kodjikian2, Marie-Hélène Errera3, Neila Sedira4, Emmanuel Heron4, Laurent Pérard5, Pierre-Loïc Cornut6, Christelle Schneider7, Sophie Rivière8, Priscille Ollé9, Grégory Pugnet10, Pascal Cathébras11, Pierre Manoli12, Bahram Bodaghi13, David Saadoun14, Stéphanie Baillif15, Nathalie Tieulie16, Marc Andre17, Frédéric Chiambaretta18, Nicolas Bonin18, Philip Bielefeld19, Alain Bron20, Frédéric Mouriaux21, Boris Bienvenu22, Stéphanie Vicente23, Sylvie Bin23, Christiane Broussolle24, Evelyne Decullier23, Pascal Sève24. 1. Department of Internal Medicine, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France. Electronic address: audrey.de-parisot-de-bernecourt@chu-lyon.fr. 2. Department of Ophthalmology, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France. 3. Department of Ophthalmology, Quinze-Vingts Hospital, Paris, France. 4. Department of Internal Medicine, Quinze-Vingts Hospital, Paris, France. 5. Department of Internal Medicine, Edouard-Herriot Hospital, Lyon, France. 6. Department of Ophthalmology, Edouard-Herriot Hospital, Lyon, France. 7. Department of Ophthalmology, Hospital, Montpellier, France. 8. Department of Internal Medicine, Hospital, Montpellier, France. 9. Department of Ophthalmology, Pierre-Paul Riquet Hospital, Toulouse, France. 10. Department of Internal Medicine, Purpan University Hospital, Toulouse, France. 11. Department of Internal Medicine, North Hospital, Saint-Étienne, France. 12. Department of Ophthalmology, North Hospital, Saint-Étienne, France. 13. Department of Ophthalmology, Pitié-Salpêtrière Hospital, Paris, France. 14. Department of Internal Medicine, Pitié-Salpêtrière Hospital, Paris, France. 15. Department of Ophthalmology, Archet Hospital, Nice, France. 16. Department of Internal Medicine, Archet Hospital, Nice, France. 17. Department of Internal Medicine, Gabriel-Montpied Hospital, Clermont-Ferrand, France. 18. Department of Ophthalmology, Gabriel-Montpied Hospital, Clermont-Ferrand, France. 19. Department of Internal Medicine, General Hospital, Dijon, France. 20. Department of Ophthalmology, General Hospital, Dijon, France. 21. Department of Ophthalmology, Hospital, Caen, France. 22. Department of Internal Medicine, Hospital, Caen, France. 23. Hospices Civils de Lyon, Pole IMER, Lyon, France. 24. Department of Internal Medicine, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France.
Abstract
PURPOSE: To prospectively assess the efficiency of a standardized diagnostic approach, compared to an open strategy, for the etiologic diagnosis of uveitis. DESIGN: Noninferiority, prospective, multicenter, clustered randomized controlled trial. METHODS:Consecutive patients with uveitis, who visited 1 of the participating departments of ophthalmology, were included. In the standardized group, all patients had a minimal evaluation regardless of the type of uveitis (complete blood count, erythrocyte sedimentation rate, C-reactive protein, tuberculin skin test, syphilis serology, and chest radiograph) followed by more complex investigations according to ophthalmologic findings. In the open group, the ophthalmologist could order any type of investigation. Main outcome was the percentage of etiologic diagnoses at 6 months. RESULTS:Nine hundred and three patients with uveitis were included from January 2010 to May 2013 and the per-protocol population comprised 676 patients (open 373; standardized 303). Mean age at diagnosis was 46 years. Anatomic distribution of uveitis was as follows: anterior (60.8% and 72.3%, P = .0017), intermediate (11.7% and 12.3%, P = .8028), posterior (17.8% and 8.2%, P = .0004), and panuveitis (15.3% and 15.2%, P = .9596). An etiologic diagnosis was established in 54.4% of cases in the open group and 49.5% in the standardized group (P = .2029). The difference between both strategies (standardized minus open) was -4.9% (95% CI [-12.5%; 2.6%]). There were more investigations in the open group than in the standardized group (5371 vs 3759, P < .0001). CONCLUSION: The standardized strategy appears to be an efficient diagnostic approach for the etiologic diagnosis of uveitis, although its noninferiority cannot be proved.
RCT Entities:
PURPOSE: To prospectively assess the efficiency of a standardized diagnostic approach, compared to an open strategy, for the etiologic diagnosis of uveitis. DESIGN: Noninferiority, prospective, multicenter, clustered randomized controlled trial. METHODS: Consecutive patients with uveitis, who visited 1 of the participating departments of ophthalmology, were included. In the standardized group, all patients had a minimal evaluation regardless of the type of uveitis (complete blood count, erythrocyte sedimentation rate, C-reactive protein, tuberculin skin test, syphilis serology, and chest radiograph) followed by more complex investigations according to ophthalmologic findings. In the open group, the ophthalmologist could order any type of investigation. Main outcome was the percentage of etiologic diagnoses at 6 months. RESULTS: Nine hundred and three patients with uveitis were included from January 2010 to May 2013 and the per-protocol population comprised 676 patients (open 373; standardized 303). Mean age at diagnosis was 46 years. Anatomic distribution of uveitis was as follows: anterior (60.8% and 72.3%, P = .0017), intermediate (11.7% and 12.3%, P = .8028), posterior (17.8% and 8.2%, P = .0004), and panuveitis (15.3% and 15.2%, P = .9596). An etiologic diagnosis was established in 54.4% of cases in the open group and 49.5% in the standardized group (P = .2029). The difference between both strategies (standardized minus open) was -4.9% (95% CI [-12.5%; 2.6%]). There were more investigations in the open group than in the standardized group (5371 vs 3759, P < .0001). CONCLUSION: The standardized strategy appears to be an efficient diagnostic approach for the etiologic diagnosis of uveitis, although its noninferiority cannot be proved.
Authors: Luca Cantarini; Claudia Fabiani; Francesca Della Casa; Antonio Vitale; Silvana Guerriero; Jurgen Sota; Rolando Cimaz; Gaafar Ragab; Piero Ruscitti; Rosa Maria R Pereira; Francesca Minoia; Emanuela Del Giudice; Giacomo Emmi; Claudia Lomater; Sara Monti; Claudia Canofari; Carla Gaggiano; Giovanni Alessio; Elisabetta Miserocchi; Alessandro Conforti; Marilia A Dagostin; Chiara Mapelli; Maria Pia Paroli; Veronica Parretti; Valeria Albano; Rosa Favale; Luca Marelli; Mohamed Tharwat Hegazy; Paola Cipriani; Isabele P B Antonelli; Valeria Caggiano; Emma Aragona; Ahmed Hatem Laymouna; Gian Marco Tosi; Maria Tarsia; Marco Cattalini; Francesco La Torre; Giuseppe Lopalco; Ewa Więsik-Szewczyk; Micol Frassi; Stefano Gentileschi; Heitor F Giordano; Bruno Frediani; Samuel K Shinjo; Donato Rigante; Petros P Sfikakis; Alberto Balistreri; Mohamed A Hussein; Rana Hussein Amin Journal: Ophthalmol Ther Date: 2022-01-31