The HARMONIC project: study design for the assessment of radiation doses and associated cancer risks following cardiac fluoroscopy in childhood.
The HARMONIC project: study design for the assessment of radiation doses and associated cancer risks following cardiac fluoroscopy in childhood.
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DOI：
10.1088/1361-6498/aba66d
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发表时间：
2020-09-24
期刊：
影响因子：
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通讯作者：
Dabin, Jeremie
中科院分区：
文献类型：
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作者：
Harbron, Richard W;Thierry-Chef, Isabelle;Dabin, Jeremie
HARMONIC项目（儿科心脏透视和现代放射治疗的健康影响）是一项欧洲研究，旨在提高我们对儿童和成年早期辐射暴露的长期健康风险的理解。在此，我们介绍了HARMONIC心脏透视组件的研究设计。将根据医院记录和/或保险索赔数据，建立一个在比利时、法国、德国、意大利、挪威、西班牙或英国接受心脏透视检查的约100000例年龄在22岁以下的患者的汇总队列。将使用基于查找表的剂量测定系统，根据检查时记录的剂量指标估计单个器官的剂量，该系统使用Monte Carlo辐射传输模拟和解剖学上真实的计算体模模型生成。将从辐射剂量结构化报告的代表性样本中获得射束几何形状和X射线能谱的信息。将使用2D Monte Carlo方法对非接触剂量估计值进行建模。该队列将使用国家登记和保险记录进行随访，以确定生命状态和癌症发病率。器官移植（该患者组发生癌症的主要风险因素）和/或其他易患癌症的疾病的相关信息将从国家或当地登记研究和健康保险数据中获得，具体取决于国家。将使用回归模型研究估计辐射剂量与癌症风险之间的关系。结果将改善患者和家长的信息，并帮助临床医生管理和实施变化，以减少辐射风险，而不影响医疗效益。
The HARMONIC project (Health Effects of Cardiac Fluoroscopy and Modern Radiotherapy in Paediatrics) is a European study aiming to improve our understanding of the long-term health risks from radiation exposures in childhood and early adulthood. Here, we present the study design for the cardiac fluoroscopy component of HARMONIC. A pooled cohort of approximately 100000 patients who underwent cardiac fluoroscopy procedures in Belgium, France, Germany, Italy, Norway, Spain or the UK, while aged under 22 years, will be established from hospital records and/or insurance claims data. Doses to individual organs will be estimated from dose indicators recorded at the time of examination, using a lookup-table-based dosimetry system produced using Monte Carlo radiation transport simulations and anatomically realistic computational phantom models. Information on beam geometry and x-ray energy spectra will be obtained from a representative sample of radiation dose structured reports. Uncertainties in dose estimates will be modelled using 2D Monte Carlo methods. The cohort will be followed up using national registries and insurance records to determine vital status and cancer incidence. Information on organ transplantation (a major risk factor for cancer development in this patient group) and/or other conditions predisposing to cancer will be obtained from national or local registries and health insurance data, depending on country. The relationship between estimated radiation dose and cancer risk will be investigated using regression modelling. Results will improve information for patients and parents and aid clinicians in managing and implementing changes to reduce radiation risks without compromising medical benefits.