OcumERe
Ocular manifestations of rheumatic disorders Egyptian Registry
Project Managers
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Prof. Nagwa Nassar
Ain Shams University
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Prof. Ahmad El Shambaky
Banha University
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Prof. Nihal Fathy
Assuit University
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Prof. Eman Abdel Latif
Alexandria University
Objectives
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General Objective
Concerning the initial treatment of Rheumatic diseases with ocular affection in daily practice this project proposes to describe the Egyptian daily clinical practice reality, delayed diagnosis of ocular affection with most rheumatic diseases.
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Specific Objectives
Primary objectives
in patients diagnosed with Rheumatic diseases with ocular affection , the time between the diagnosis and the initiation of therapy and T2T recommendations of the initial phase of clinical management to assess the frequency of achievement of the 12 month target.
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Secondary objectives
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• Early diagnosis and start of any Conventional or biologic DMARDs.
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• To estimate the incidence and prevalence of Rheumatic diseases with ocular affection among Egyptian populations.
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• To estimate the average time between the onset of symptoms and the first diagnosis.
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• To estimate the average time between diagnosis and the first dosage of treatment.
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• To estimate the average time between visits.
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• To estimate the frequency of prescription of Conventional DMARDs and the different/preferred routes of administration:
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• To estimate the frequency of therapies with combination Conventional & biologic DMARDs.
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• To estimate the frequency of patients who start the drug and failed to achieve remission.
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• To estimate the frequency of prescription of different biological drugs after the failure of Conventional DMARDs
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• To estimate the frequency of patients who do not start the biological drug despite the clinical, laboratory indications.
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• To identify the limitations to use biological therapy despite the physician/patient consensus.
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• To evaluate the frequency of adverse events to Conventional DMARDs.
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• To evaluate the frequency of adverse events to biological DMARDs
Study design
Mixed cohort study. Prospective Study & Retrospective Study
Recruitment centers
All rheumatology departments among the Egyptian universities, in addition to some of the potential rheumatology private clinics will have a unique username and password to login and add his last recruitment patients: Consecutive patients. Recruitment 18 months. Minimum 12 month follow-up (First patient assessed: 30 months) study.
Inclusion Criteria
Patients diagnosed with Rheumatic diseases with ocular affection performed by the rheumatologist and opthalmogists who initiate initial treatment with conventional or biological DMARDs.
Exclusion Criteria
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Patients younger than 18 years
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Patients not able or refusing to provide informed consent.
Factors of interest (exposure variables)
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Demographic variable
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Serological subset
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Clinical settings (outpatient / hospital / center analysis)
Analysis plan
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Analysis of the primary outcome
Primary outcomes will be estimated as a mean therapeutic delay and as a probability (risk) of achievement of the target / or adherence to recommendations and 95% confidence intervals
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Analysis of secondary outcomes
Secondary outcomes will be estimated in a similar way to primary ones
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Explorative analysis
The influence of demographic, clinical (serological), therapeutic factors (association with glucocorticoids), organizational (setting), pathway (time to referral, to diagnosis ,to treatment) on the variables of longitudinal outcome (target achievement, treatment survival, adverse events, biological switch) will be explored using regression models appropriate to type of outcome variable.