ABSTRACT
PURPOSE: To evaluate the long-term efficacy and safety of infliximab as treatment for noninfectious posterior uveitis. METHODS: An open-label clinical trial including seven patients (12 eyes) with posterior uveitis refractory to conventional treatment regimens with corticosteroids and at least one immunosuppressive agent. Three intravenous doses of 5 mg/kg of infliximab were administered at weeks 0, 2, and 6. Infliximab infusion was repeated in patients undergoing a relapse of uveitis after initial remission. Improvement was defined as amelioration of visual acuity or disappearance of retinal exudates and/or haemorrhages, decreased macular oedema and/or vitreous opacities. All patients were followed up for at least 36 months. RESULTS: Six of the seven patients (five diagnosed with Behçet's disease and one diagnosed with sarcoidosis) showed a significant improvement after the first infliximab dose. Only in one patient diagnosed with chronic idiopathic multifocal choroiditis did the drug have no effect, and this patient was withdrawn from the study. At the end of follow-up, one eye had lost one line of vision and three eyes showed improved vision. All eyes had improved in terms of signs of inflammation. No adverse effects of treatment were observed. CONCLUSION: Infliximab is efficient and safe for the long-term management of refractory posterior uveitis, especially in patients with predominant retinal vasculitis and vitritis.
Subject(s)
Antibodies, Monoclonal/therapeutic use , Immunosuppressive Agents/therapeutic use , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Uveitis, Posterior/drug therapy , Adult , Aged , Behcet Syndrome/drug therapy , Behcet Syndrome/physiopathology , Drug Administration Schedule , Female , Humans , Infliximab , Male , Middle Aged , Prospective Studies , Recurrence , Treatment Outcome , Uveitis, Posterior/physiopathology , Visual AcuityABSTRACT
BACKGROUND: Clinical-epidemiological research often requires using data stored in clinical records. There is a paucity of systematic studies of errors in the data extraction process from clinical records in the medical literature. In order to assess the increment of reliability in data extraction from clinical records due to training, we estimate the degree of agreement in the data extraction process from clinical records of rheumatoid arthritis patients. MATERIAL AND METHODS: Test-retest, quasi-experimental study. A random sample of clinical records was selected from a rheumatoid arthritis patients register. The degree of agreement between the two observers, before and after a specific training, was estimated with kappa and intraclass correlation coefficients. RESULTS: Following standardized ranking of the degree of agreement, we observed that 5 out 19 (26%) studied variables improved significantly after training and 14 (74%) remained with the same degree of agreement or did not change significantly. At the end of the study, only two variables received a degree of agreement less than good whereas six did so before training. The improvement was noted in the clinical variables. CONCLUSIONS: It is possible to have a systematic approach to the source of errors in the use of data from clinical records. The training of observers has a significant impact on the degree of agreement and therefore improves reliability. The training in the extraction and management of clinical information may contribute to the improvement of validity and reliability of observations in medical practice.
