Prognosis and Management of Infective Endocarditis Using the Clinical Data Warehouse From AP-HP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- All-cause mortality defined 1 year after the date of IE diagnosis (T0 = Date of diagnostic echocardiography)
研究概览
简要总结
"Infective endocarditis (IE) is a rare but severe condition with significant morbidity and mortality, with in-hospital mortality reaching 20% and 1-year mortality up to 40%. The epidemiological profile of IE has profoundly changed in recent years, both in terms of responsible microorganisms and affected populations, shifting from young adults with post-rheumatic valvulopathy to older populations with degenerative valve disease or prosthetic implants. Prophylaxis and management recommendations have also evolved, underscoring the importance of monitoring the evolution of IE profiles in France.
Despite these changes, there is no standardized surveillance for IE in France, and existing studies often rely on data from specialized centers, introducing selection biases. Moreover, another important limitation when studying IE using medical-administrative basis, like the french nationwide claims database (SNDS), is the poor performances of administrative coding (ICD-10) in accurately identifying IE cases.
The ""ENDO-EDS"" project aims to leverage the extensive data available in the APHP Clinical Data Warehouse (CDW) to study IE in a real-world, unbiased context. Indeed, the AP-HP clinical data warehouse, with 11 million patients, offers the opportunity to identify IE cases across a large population base and, due to the presence of both expert and non-expert IE hospitals, to describe the characteristics of the disease while reducing bias risks. In addition, AP-HP CDW contains medical reports and other documents emitted during patient' stays in hospital, thus enabling to overcome ICD-10 coding limitations, by utilizing a large-scale clinical data repository combined with advanced Natural Language Processing (NLP) algorithms.
The anticipated benefits include improving knowledge of the epidemiological profile of IE, describing diagnostic and therapeutic management practices, and studying their impact on patient prognosis. These efforts aim to contribute to the improvement of IE diagnosis and management in France. The results will be published as scientific articles in open-access peer-reviewed journals. Additionally, the development and validation of algorithms based on automated language processing for identifying patients with IE within the AP-HP data warehouse could be shared to extend subsequent analyses to other French or even European health data warehouses."
详细描述
"1. Introduction
Infective endocarditis (IE) is a rare but serious disease, with an incidence of 3-6 cases per 100,000 per year in France and a hospital mortality rate of 20%, increasing to 40% at five years. Over recent decades, the epidemiological profile of IE has significantly evolved. Previously identified as a disease of young adults with well-defined predisposing valvular conditions, such as post-rheumatic valvulopathy, IE now primarily affects older patients, many without identifiable valvular disease.
IE results from bacterial colonization of a sterile fibrin-platelet vegetation on damaged endocardium. Changes in both the sources of bacteremia and valvular abnormalities have been noted. Historically, rheumatic valvular disease and cyanotic congenital heart defects were the predominant predisposing factors. The decline in rheumatic fever and early surgical correction of congenital heart defects have reduced their role. However, new risk factors, such as prosthetic valves, degenerative valvular sclerosis, and invasive medical procedures, have emerged.
Despite these changes, the incidence of IE has not decreased. Microbiological profiles have also shifted. Meta-analyses indicate that staphylococci have surpassed oral streptococci as the leading causative organisms. This shift varies geographically; for instance, IE caused by Staphylococcus aureus is more prevalent in the United States than in Europe. Factors contributing to these differences include dialysis, diabetes, and intravenous drug use in certain regions.
Prophylaxis guidelines have undergone significant revisions. In France, since 2002, antibiotic prophylaxis has been limited to high-risk patients, such as those with prosthetic valves or prior IE, reflecting evidence-based recommendations to reduce unnecessary antibiotic use and resistance. This paradigm shift may influence the epidemiology of IE, necessitating ongoing surveillance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
All-cause mortality defined 1 year after the date of IE diagnosis (T0 = Date of diagnostic echocardiography)
时间窗: 1 year after the date of IE diagnosis (T0 = Date of diagnostic echocardiography)
次要结局
- Post-Acute Phase Outcomes Following Infective Endocarditis: One-Year Rehospitalization rate(one year)
- Post-Acute Phase Outcomes Following Infective Endocarditis: Surgical Intervention Rate(one year)
- Post-Acute Phase Outcomes Following Infective Endocarditis: IE Relapse rate(one year)
- Performance (Sensitivity, Specificity, Positive predictive value, Negative predictive value) of ICD-10 diagnostic codes (I33, I38, T826, B376, I39) from PMSI stays to identify an IE(one year)
- Characteristics associated with the patient care pathway(one year)
- Rate of patients with an IE for whom a report of multidisciplinary case reviews (RCP) appears in EDS(one year)
- In-hospital death rate(Up to 6 week after IE diagnosis)
- Rate of patients who benefited from imaging procedures performed in the acute phase of IE (within 6 weeks following T0) identified from CCAM codes(CCAM codes emitted within 6 weeks from T0 (date of IE determined through echocardiographic diagnosis))
- Rate of patients who underwent cardiac valve replacement surgery in the acute phase of IE(Up to 6 week after IE diagnosis)
- Clinical characteristics of patients with IE at diagnosis, extracted from administrative data (ICD-10 diagnoses, and CCAM medical procedures) and medical reports(All data emitted in AP-HP hospitals prior to hospitalization for IE)
- Microorganisms associated with IE, extracted from hospitalization medical reports using NLP(Up to 6 week after IE diagnosis)
- Iconographic characteristics of IE at diagnosis(Up to 6 week after IE diagnosis)
- Complications of infective endocarditis occurring during hospitalization, extracted from administrative data (ICD-10 diagnoses)(Up to 6 week after IE diagnosis)
- Rate of patients who had an oral relay of antibiotic therapy in the acute phase(Up to 6 week after IE diagnosis)
- time between T0 and introduction of the oral relay(Up to 6 week after IE diagnosis)
- Post-Acute Phase Outcomes Following Infective Endocarditis: IE Recurrence rate(one year)