A Retrospective Observational Real-world Study to Evaluate Diagnosis Pattern, Treatment Pattern and Effectiveness of Eradication Treatment in Helicobacter Pylori (H. Pylori) Patients in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23,000
- 试验地点
- 5
- 主要终点
- Percentage of Each Eradication Regimen Initially Prescribed After Index Date
研究概览
简要总结
The main aim of the study is to review treatment therapies in people with Helicobacter pylori (H. pylori) infections in standard hospital settings in China.
In this study, the study doctors will review medical records of participants who have had H. pylori infections any time from 1st January 2019 to 31st December 2021. This study is about collecting existing data only; participants are not treated and do not need to visit a study doctor during this study.
详细描述
This is a non-interventional, retrospective cohort study of participants who have evidence of H. pylori infection using pre-existing electronic medical record data in China. This study will evaluate the distribution of methods of eradication therapy among participants who received medications that were used in the eradication therapy for H. pylori infection.
Retrospective de-identified participant-level data will be collected primarily from hospitals in China between 1st January 2019 to 31st December 2021. The extracted electronic medical record dataset will include patient demographic information, visit information, diagnosis information, treatment information, and cost information (if available). All the participants will be assigned to a single observational cohort:
• Participants with H. pylori
This multi-center study will be conducted in China. The overall study duration will be approximately 54 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a record of H. pylori infection diagnosis or positive result of H. pylori diagnostic testing between 1st January 2019 and 31st December 2021.
排除标准
- •Not applicable.
结局指标
主要结局
Percentage of Each Eradication Regimen Initially Prescribed After Index Date
时间窗: Up to 36 months
Eradication therapy in this study includes standard bismuth quadruple therapy, standard triple therapy, and dual therapy. Eradication therapy will be identified according to the combination of drugs that are prescribed on the same day. Index date will be defined as first diagnosis date or the first date of a positive result of H. pylori diagnostic testing whichever came first during the participant identification period. For the percentage calculation of each eradication regimen, the denominator is the total usage count of all standard eradication therapies taken by eligible participants and the numerator is the total usage count of each eradication therapy.
次要结局
- Percentage of the Duration From the Termination of Eradication Therapy Until the Efficacy Evaluation Testing(Up to 36 months)
- Percentage of Each Eradication Therapy's Treatment Duration From the Date of Prescription Until the Termination(From date of prescription up to 14 days)
- Percentage of Each Diagnostic Testing Used Before the Prescription of Eradication Therapy(Up to 36 months)
- Percentage of Each Efficacy Evaluation Testing After the Termination of Eradication Therapy(Up to 36 months)