The Cost-effectiveness Analysis of Immunosuppressants to Postoperative Infection and Death in the Patients With Organ Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Postoperative infection
研究概览
简要总结
The goal of this observational study is to explore the different immunosuppressive agents and related outcomes in organ transplantation patients in Taiwan. The main question it aims to answer is the risk of different immunosuppressive agents for infection and survival after transplant.
The study enrolled patients who underwent solid organ transplant (SOT), kidney (ICD-9-CM code V42.0), liver (ICD-9-CM code V42.7), or lung (ICD-9-CM code V42.6) transplants. We employed propensity score matching (PSM) to establish a matched cohort. The study will compare SOT patients and general patients to explore the risk of different immunosuppressive agents for infection and survival.
详细描述
This study used secondary data from the Longitudinal Health Insurance Database (LHID), a subset of the NHIRD provided by the Health and Welfare Data Science Center (HWDC) of the Ministry of Health and Welfare in Taiwan.
The HWDC encrypts personally identifying data to protect the privacy of beneficiaries. The database includes detailed clinical records from both the inpatient and outpatient claims of the beneficiaries of Taiwan's National Health Insurance program. This program has provided coverage for up to 99% of the country's population since 1995. The NHIRD can serve as a foundation for the procurement of real-world evidence to support clinical decisions and health-care policy-making.
Diagnostic data within the NHIRD from before 2016 and from 2016 or later are respectively coded using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes.
The database was provided by the HWDC under license and so cannot be made freely available. Requests for access to these data should be made to HWDC (https://dep.mohw.gov.tw/dos/cp-5119-59201-113.html).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who underwent solid organ transplant (SOT)
排除标准
- •Patients who received more than one SOT, had an infectious disease diagnosis before their SOT or had incomplete medical information in the database.
研究组 & 干预措施
Patients with organ transplantation
Patients who underwent SOTs between 2002 and 2013, specifically, kidney (ICD-9-CM code V42.0), liver (ICD-9-CM code V42.7), or lung (ICD-9-CM code V42.6) transplants.
干预措施: Immunosuppressive Agents (Drug)
Patients without organ transplantation
The general patients were enrolled as the comparison. We used propensity score matching (PSM) to establish a matched cohort.
干预措施: Immunosuppressive Agents (Drug)
结局指标
主要结局
Postoperative infection
时间窗: From the date of underwent SOTs until the date of incident infection or date of death from any cause, whichever came first, assessed up to 5 years.
Postoperative infection contains Pneumocystis jiroveci pneumonia, cytomegalovirus disease, and Herpes simplex virus
Death
时间窗: From the date of underwent SOTs until the date of death from any cause, assessed up to 5 years.
Death
次要结局
未报告次要终点