Uveitis: Medico-economical and Clinical Evaluation of a Standardized Strategy for an Etiological Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 905
- 试验地点
- 2
- 主要终点
- The primary outcome is the percentage of patients having an etiological diagnosis 6 months after the beginning of the study for both strategies.
研究概览
简要总结
The Uveitis, the inflammation of the uvea, is a rare disease with an incidence of 52/100,000 inhabitants per year and a prevalence of 115 / 100,000 inhabitants per year.
The causes of uveitis are numerous and include infectious diseases, systemic and neurological diseases, ophthalmic entities, neoplasia, and drug-related reactions. The etiological diagnosis is important both for prognosis and therapeutics.
However, clinical evaluations to establish etiological diagnosis are not standardized. Some authors suggest a minimalist examination, common to all kinds of uveitis. On the other hand, others propose an evaluation guided by the anatomo-clinical type of uveitis.
We conducted a retrospective study to assess the contribution of complementary examinations to etiological determination. In this study, we found that most patients benefited from a wide paraclinical evaluation compared to what is usually described in the literature. Complementary examinations were mostly systematic, without any clinical or ophthalmological elements of orientation. This study highlighted the lack of contribution of some examinations.
Using these results, and the literature analysis, we designed a diagnostic algorithm adapted to the anatomo-clinical type of uveitis.
Moreover, we found that the average cost per patient was estimated at €290.51 with the algorithm compared to €560.83 without it.
We would like to carry out a new study to estimate the efficiency as well as the medico-economic impact of the use of a standardized strategy for the etiological diagnosis of uveitis, compared with a free strategy.
Hypothesis:
- The standardized strategy for the diagnostic of uveitis is at least as efficient as the free one, and costs half as much.
- The examinations prescribed, except for those from the standardized strategy, do not contribute to etiological determination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient consulting one of the study's sites
- •Age > 18 years old
- •Affiliation to the French national health insurance program
- •Patient agreeing to participate in the study
排除标准
- •Positive HIV serology
- •Postsurgical or posttraumatic uveitis or endophthalmitis
- •Toxoplasmic uveitis
- •Pathology likely to be the cause of the known uveitis
- •Ophthalmic entities only diagnosed by the ophthalmic examination
- •Age < 18 years old
- •Patient under law protection or guardianship
- •Pregnant women or those planning to be pregnant during the study
- •Severe uveitis (VA < 20/200) with retinal vascularitis requiring an emergency treatment and assessment.
研究组 & 干预措施
Free strategy
Free strategy followed in order to make the etiological diagnosis, which means, investigators are free to perform any examination they thought necessary.
干预措施: Free strategy (Other)
Experimental strategy
Etiological diagnosis made by following a standardized two-stage strategy: first-line assessment (listed examinations and then examinations directed by the clinical or para-clinical elements of orientation) and second or third-line assessment (examinations directed by the anatomo-clinical type of uveitis).
干预措施: Standardized strategy (Other)
结局指标
主要结局
The primary outcome is the percentage of patients having an etiological diagnosis 6 months after the beginning of the study for both strategies.
时间窗: 6 months
Note: Only diagnoses made at the end of the standardized strategy will be numbered in this arm of the study; all diagnoses made after by the free authorized examinations in this same arm will lead to standardized strategy failure.
次要结局
- Clinical criteria concerning the standardized strategy(6 months)
- Clinical criteria concerning the free strategy(6 months)
- The average cost of economic criteria for each strategy.(12 months)
- Quality of life criteria(: 6 months)
- Clinical criteria concerning the standardized strategy(6 months)
- Clinical criteria concerning the free strategy(6 months)
- The average cost of economic criteria for each strategy.(12 months)
- Quality of life criteria(: 6 months)