Hepatitis C Surveillance With Linkage to Care of Patients From Non-ID Departments in Jiangsu
Hepatitis C Surveillance With Linkage to Care of Patients From Non-infectious Departments in Tertiary Hospitals From Jiangsu, China
Due to the occult nature of hepatitis C virus (HCV), it is estimated that less than 5% of people with chronic hepatitis C (CHC) infection knowing their status. The major challenges are that awareness is lacking, reliable diagnostics and testing services are not sufficiently available, and laboratory capacity is weak. In the context of major tertiary hospitals, the well-functioning laboratories would ensure the high-quality HCV testing, which facilitate the identification of inpatients who are unaware of HCV infection. However, given the preliminary data, diagnostic rate of inpatients from non-infectious (non-ID) departments is disturbingly low. A recent study from a major hospital in Jilin province of China showed that 3.36% of inpatients were anti-HCV positive; however, HCV RNA confirmatory testing was not further performed in this study.
From the retrospective cohort in non-ID departments of a tertiary hospital of Jiangsu during 2016 to 2017, only 25.9% (71/273) of patients with anti-HCV antibody (Ab) further had HCV RNA confirmatory test, while 40% (29/71) were identified as CHC. The previous data indicates that insufficient anti-HCV Ab testing and insufficient follow-up of patients with positive anti-HCV Ab from non-ID departments. Indeed, compared to hospitals in Western countries, the infectious department in Chinese hospitals are relative independent from non-ID departments, meanwhile the knowledge of HCV infection is relatively lacking for non-ID physicians. Therefore, an appropriate clinical pathway for integration and linkage of non-ID department and ID departments for diagnosis and care delivery of CHC patients is urgently needed. The investigator aim to establish a feasible clinical pathway and consensus guideline to enhance HCV testing surveillance with linkage to care in non-ID departments. Moreover, the participants with anti-HCV Ab also will be enrolled in the HCV prospective cohort, in which the intervention and clinical outcome of hepatitis will be longitudinally monitored in the future study.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Jiangsu
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Changzhou、Jiangsu、中国、213001
- The Third Hospital of Changzhou
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Nanjing、Jiangsu、中国、210008
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Retrospective cohort:
- ≥ 18 years of age.
- Inpatients from non-infectious department.
- Documentation of laboratory test indicating positive HCV antibody.
Prospective cohort:
- ≥ 18 years of age.
- Inpatients from non-infectious departments.
Patients who meet the requirement of HCV antibody screening:
- patients with high risk possibility of HCV infection.
- patients who will have special or invasive medical operation.
- patients with unexplained abnormal liver biochemical laboratory results.
Exclusion Criteria:
Retrospective cohort: Duplicated subjects.
Prospective cohort:Inability or unwillingness to provide informed consent or abide by the requirements of the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:放映
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:HCV screening
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HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test.
大体时间:1 years
|
1 years
|
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The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening.
大体时间:1 years
|
1 years
|
|
The percentage of HCV-RNA positivity linkage to care consensus guideline shaped.
大体时间:1 years
|
1 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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The percentage of CHC patients linked to care in non-infectious departments.
大体时间:1 years
|
1 years
|
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The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment.
大体时间:1 years
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1 years
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The referral rate of identified HCV infected patients.
大体时间:1 years
|
1 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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