在SHINE TB治疗缩短试验中使用的儿科胸部X射线分类的方法和过程
M Palmer1, M M van der Zalm1, H S Schaaf1
1Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.
在SHINE试验中,胸部X射线 (CXR) 分类确保了儿童结核病 (TB) 治疗缩短的资格. 当地的临床医生.
科学领域:
- 儿童传染病 儿童传染病
- 放射学 放射学是一门学科.
- 临床试验方法论 临床试验方法论
背景情况:
- 该SHINE (儿童最小结核病缩短治疗) 试验是第一个调查儿童结核病治疗缩短的第3期研究.
- 准确的胸部X射线 (CXR) 解释对于患者的资格,定义基线疾病严重程度和判断结核病状况至关重要.
- 标准化的CXR分类对于临床研究和儿科结核病的常规管理至关重要.
研究的目的:
- 描述和批判性地评估SHINE儿科结核试验中使用的胸部X射线 (CXR) 分类方法.
- 评估CXR解释的可行性,安全性和准确性,用于儿童的试验资格和疾病严重程度评估.
- 为改进基于CXR的方法提供信息,以便在日常护理和未来研究中实现标准化实施.
主要方法:
- 患有放射性非严重结核病的儿童被招募并随机分配到4个月和6个月的抗结核治疗方案中.
- 在现场的临床医生前地解释了CXR的资格,定义了放射性不严重的疾病.
- 专家读者追溯审查了CXR,以判断基线结核病状况和评估疾病严重程度.
主要成果:
- 所有1,204名被录取的儿童都有查CXR;1,134名患有胸内结核的儿童的CXR被专家审查.
- 与专家小组相比,招募的临床医生将更多的CXR确定为异常和"典型的结核病",但所有这些都被归类为放射性不严重.
- 专家小组确定71/1,134 (6%) 的CXR是严重的,与整体试验 (3.0%) 相比,这一子组的不良结果率 (5.6%) 较高.
结论:
- 在SHINE试验中,利用CXRs实时分类放射性疾病严重程度和当地临床医生的资格是可行的和安全的.
- 追溯的中央专家CXR审查证明了对准确的疾病评估的成功.
- 针对疾病严重程度和结核病状况的精细CXR分类方法可以提高儿科结核病护理和研究的标准化.
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