de Parisot Audrey, Kodjikian Laurent, Errera Marie-Hélène, Sedira Neila, Heron Emmanuel, Pérard Laurent, Cornut Pierre-Loïc, Schneider Christelle, Rivière Sophie, Ollé Priscille, Pugnet Grégory, Cathébras Pascal, Manoli Pierre, Bodaghi Bahram, Saadoun David, Baillif Stéphanie, Tieulie Nathalie, Andre Marc, Chiambaretta Frédéric, Bonin Nicolas, Bielefeld Philip, Bron Alain, Mouriaux Frédéric, Bienvenu Boris, Vicente Stéphanie, Bin Sylvie, Broussolle Christiane, Decullier Evelyne, Sève Pascal
Department of Internal Medicine, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France.
Department of Ophthalmology, Hospices Civils de Lyon, Croix-Rousse Hospital, Lyon, France.
Am J Ophthalmol. 2017 Jun;178:176-185. doi: 10.1016/j.ajo.2017.03.029. Epub 2017 Mar 31.
To prospectively assess the efficiency of a standardized diagnostic approach, compared to an open strategy, for the etiologic diagnosis of uveitis.
Noninferiority, prospective, multicenter, clustered randomized controlled trial.
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.
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).
The standardized strategy appears to be an efficient diagnostic approach for the etiologic diagnosis of uveitis, although its noninferiority cannot be proved.
前瞻性评估标准化诊断方法与开放策略相比，在葡萄膜炎病因诊断中的效率。
非劣效性、前瞻性、多中心、整群随机对照试验。
纳入连续就诊于参与研究的眼科科室之一的葡萄膜炎患者。在标准化组中，所有患者无论葡萄膜炎类型均进行最低限度评估（全血细胞计数、红细胞沉降率、C反应蛋白、结核菌素皮肤试验、梅毒血清学及胸部X线片），然后根据眼科检查结果进行更复杂的检查。在开放组中，眼科医生可安排任何类型的检查。主要结局是6个月时病因诊断的百分比。
2010年1月至2013年5月纳入903例葡萄膜炎患者，符合方案人群包括676例患者（开放组373例；标准化组303例）。诊断时的平均年龄为46岁。葡萄膜炎的解剖分布如下：前部（60.8%和72.3%，P = 0.0017）、中间部（11.7%和12.3%，P = 0.8028）、后部（17.8%和8.2%，P = 0.0004）及全葡萄膜炎（15.3%和15.2%，P = 0.9596）。开放组54.4%的病例及标准化组49.5% 的病例确立了病因诊断（P = 0.2029）。两种策略之间的差异（标准化组减去开放组）为-4.9%（95%CI[-12.5%；2.6%]）。开放组的检查比标准化组更多（5371次对3759次，P < 0.0001）。
标准化策略似乎是葡萄膜炎病因诊断的一种有效诊断方法，尽管其非劣效性无法得到证实。
