Establishment of technical specifications for data sharing in esophageal cancer screening cohort based on FHIR model and CDASH model
YUE He-xin and GUI Lu-ting contributed equally to this article
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摘要:
目的 通过制定食管癌筛查队列数据标准，促进食管癌筛查队列之间的数据整合、共享和利用。 方法 通过系统全面检索中文、英文数据库，筛选出高质量且有代表性的食管癌筛查队列，提取其基础、重要的数据资源。学习并参考快捷医疗保健互操作资源(Fast Healthcare Interoperability Resources, FHIR)和临床数据采集标准(Clinical Data Acquisition Standards Harmonization, CDASH)模型，引用数据变量定义，建立食管癌筛查队列数据标准。 结果 本研究共纳入现有的8个高质量食管癌筛查队列，提取其中的数据资源，与FHIR和CDASH数据标准模型的匹配度较高，初建数据标准可行。 结论 食管癌筛查队列数据标准的建立，为今后建立食管癌筛查队列时需收集的数据资源和问卷内容提供思路。 Abstract:Objective To promote the data integration, sharing and utilization of esophageal cancer screening cohorts by establishing a data standard. Methods We systematically and comprehensively retrieved relative databases and selected representative esophageal cancer screening cohorts with high-quality. Relevant information were extracted from these studies, then we have referenced the fast healthcare interoperability resources (FHIR) model and clinical data acquisition standards harmonization (CDASH) model to define variables and establish the data standard. Results In this study, eight high-quality esophageal cancer screening cohorts were included. Their data matched well with the FHIR and CDASH models, which proves that the newly established data standard was feasible. Conclusion The establishment of the data standard of esophageal cancer screening cohorts helps with future cohort design and data collection. -
Key words:
- Esophageal carcinoma /
- Cohort /
- Data /
- Standard
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图 1 食管癌筛查队列数据标准建立流程图
Figure 1. The flow chart of establishment of data standard for esophageal cancer screening cohorts
图 2 食管癌筛查队列文献检索及筛选流程图
Figure 2. The flow chart of literature search and screening of esophageal cancer screening cohorts
表 1 纳入食管癌筛查队列及其特点
Table 1. The esophageal cancer screening cohorts included and their characteristics
序号 名称 国家/地区 筛选地区 筛选人群 起止时间 纳入人数 筛查方法 特点/优势 1 NCEC-HRP[10] 中国 中、东、西部的8个地区 40~69岁 2017.6―2020.12 100 000 内窥镜检查并经组织学证实，结合本地临床系统、癌症登记系统、死亡监察系统、医疗保险和索偿资料库 研究地点位于食管癌的高危地区，并选择代表中国不同的经济地理区域的多个医疗中心；选择满足条件的所有当地居民作为研究对象，目标人群相对稳定；1年随访1次，随访10年以上；主动随访和被动随访相结合 2 EPIC cohort[11] 10个国家 23个中心 全人群 1992―2000 481 419 内窥镜检查并经组织学证实，结合癌症登记系统、医疗保险系统和人口死亡登记系统 10个国家23个合作中心，研究地区包括饮食习惯和癌症风险差异较大的人群；通过生物标志物实现分子流行病学的设计；随访采用电话或信件形式 3 NHIC cohort[12] 韩国 全国 全人群 2009―2012 22 809 722 使用国家健康保险公司数据库 使用国家健康保险公司数据库(涵盖韩国97%人群)进行队列研究，范围覆盖韩国全国；2年或1年随访1次，随访时间为6.4年 4 SPREDH[13] 瑞典 全国 ≥18岁 2005―2015 8 421 115 瑞典国家健康数据登记库 数据来源于瑞典国家健康数据登记库(处方药登记处、患者登记处、癌症登记处和死因登记处)，范围覆盖瑞典全国，数据质量高；纳入队列即进行跟踪，跟踪至死亡或研究结束 5 Golestan Cohort[14] 伊朗 戈勒斯坦省 40~75岁 2004―2008 50 045 内窥镜检查并经组织学证实 研究地点为戈勒斯坦省第二大城市，食管癌发病风险较高；选择研究地区内所有符合条件的当地居民作为研究对象；1年随访1次，随访采用电话或家访形式 6 NLCS[15] 荷兰 全国 55~69岁 1986―2000 120 852 荷兰人口和癌症登记处 研究地区人口实现计算机化登记，位于癌症登记处的随访覆盖面内；研究地区癌症风险较高，具有代表性；1年随访1次 7 UK Biobank[16] 英国 全国 40~69岁 2006―2010 ＞500 000 英国生物库、初级保健系统、癌症和特定疾病登记处及国家医疗服务中央登记处 英国22个评估中心位于不同地区，研究范围覆盖全国，涵盖了各种不同的环境，实现社会经济、种族异质性和城乡混合；受试者参与研究意愿高，数据质量高 8 CKB[17] 中国 5个城市和5个农村地区 35~74岁 2004―2013 497 693 国家医疗保险系统、地区慢性病登记处和中国疾病监测点 研究地区位于中国疾病监测点控制下，考虑城乡差距的同时，保证数据质量；以行政单位(农村或居民委员会)为基础进行调查，受试者配合度高 
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表 2 纳入食管癌筛查队列的数据资源与FHIR数据标准模型匹配情况
Table 2. The situation of data resources of the esophageal cancer screening cohorts included matching with FHIR data standard models
队列名称 FHIR 姓名(Name) 电话(Telecom) 性别(Gender) 出生日期(Birth Date) 地址(Address) 婚姻状况(Marital Status) 家族史(Family Member History) 就诊(Encounter) 手术(Procedure) 诊断报告(Diagnostic Report) 药物史(Medication) 不良反应(Adverse Event) 标本(Specimen) 观察(Observation) 问卷(Questionnaire Response) NCEC-HRP √ √ √ √ √ √ √ √ √ ― √ √ √ √ √ EPIC cohort √ √ √ √ √ √ ― √ ― √ √ √ √ √ √ NHIC cohort √ √ √ √ √ √ ― √ √ √ √ √ √ √ √ SPREDH √ √ √ √ √ √ ― √ √ √ √ ― ― √ √ Golestan Cohort(GCS) √ √ √ √ √ √ √ √ √ √ √ ― √ √ √ NLCS √ √ √ √ √ √ √ √ √ √ √ ― √ √ √ UK Biobank √ √ √ √ √ √ √ √ √ √ √ ― ― √ √ CKB √ √ √ √ √ √ √ √ √ √ √ √ √ √ √
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表 3 纳入食管癌筛查队列的数据资源与CDASH模型匹配情况
Table 3. The situation of data resources of the esophageal cancer screening cohorts included matching with CDASH models
队列名称 CDASH 其他 疾病史(MH) 体格检查(PE) 死亡详情(DD) NCEC-HRP √ √ √ 社会心理情况、社会经济情况、体力活动、睡眠情况和癌前病变 EPIC cohort √ √ √ 膳食、体力活动、代谢情况、生物标志物和癌前病变 NHIC cohort √ √ √ 代谢情况、体力活动 SPREDH ― √ √ 癌症详细信息、饮食和潜在死因 Golestan Cohort(GCS) ― √ √ 体力活动、饮茶习惯、膳食、社会经济情况和生物标志物 NLCS √ √ ― 饮食、社会经济情况、体力活动、癌症详细信息和生物标志物 UK Biobank √ √ √ 社会经济情况、体力活动、基因分型、饮食和生物标志物 CKB √ √ √ 社会经济状况、饮食、体力活动和睡眠情况
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表 4 食管癌筛查队列数据相关变量定义
Table 4. The definition of relevant variables of esophageal cancer screening cohorts' data
数据标准模型类型 模块类别 变量定义 英文 中文 FHIR 研究对象(Patient) 姓名(Name) A name associated with the individual 研究对象的名字 电话(Telecom) A contact detail (e.g. a telephone number or an email address) by which the individual may be contacted 可联系研究对象的联系人详细信息(如电话号码或电子邮件地址) 性别(Gender) The gender that the patient is considered to have for administration and record keeping purposes 研究对象在管理和记录保存方面的性别 生日(Birth Date) The date of birth for the individual 研究对象的出生日期 地址(Address) An address for the individual 研究对象的地址 婚姻状况(Marital Status) This field contains a patient’s most recent marital (civil) status 研究对象最近的婚姻(民事)状态 家族史(Family Member History) 关系(Relationship) The type of relationship this person has to the patient (father, mother, brother etc.) 此人与研究对象的关系类型(父亲、母亲和兄弟等) 年龄(Age) The age of the relative at the time the family member history is recorded 记录家族性疾病发生时研究对象亲属的年龄 疾病(Condition) The significant Conditions (or condition) that the family member had 家庭成员的重要身体情况(疾病) 时间(Date) The date (and possibly time) when the family member history was recorded or last updated 家族史的记录或最近更新的日期(或时间) 结局(Condition Outcome) Indicates what happened following the condition. If the condition resulted in death, deceased date is captured on the relation 发生家族性疾病的后果。如果因家族性疾病导致死亡，则需记录死亡日期 就诊(Encounter) 类型(Class) Concepts representing classification of patient encounter such as ambulatory (outpatient), inpatient, emergency, home health or others due to local variations 研究对象就诊的分类，如门诊、住院、急诊、家庭医生或其他 时间(Encounter Period) The start and end time of the encounter 就诊开始和结束的时间 诊断(Encounter Diagnosis) The list of diagnosis relevant to this encounter 与此次就诊相关的诊断列表 饮食(Encounter Hospitalization Diet Preference) Diet preferences reported by the patient 研究对象报告的饮食偏好 手术(Procedure) 类型(Category) A code that classifies the procedure for searching, sorting and display purposes 以搜索、排序和显示为目的的手术分类代码 时间[Procedure Performed (x)] Estimated or actual date, date-time, period, or age when the procedure was performed. Allows a period to support complex procedures that span more than one date, and also allows for the length of the procedure to be captured 执行手术的估计或实际日期、时间、时段或年龄。允许复杂手术的具体时段和手术时间跨越多个日期 使用(Procedure Used Reference) Identifies medications, devices and any other substance used as part of the procedure 确定在手术过程中使用的药物、器械和任何其他物质 位置(Procedure Body Site) Detailed and structured anatomical location information. Multiple locations are allowed-e.g. multiple punch biopsies of a lesion 详细和结构化的解剖位置信息。允许多个位置(例如病变的多个穿孔活检) 并发症(Procedure Complica-tion Detail) Any complications that occurred during the procedure, or in the immediate post-performance period 手术过程中或术后立刻出现的并发症 诊断报告(Diagnostic Report) 时间[Diagnostic Report Effective (x)] The time or time-period the observed values are related to. When the subject of the report is a patient, this is usually either the time of the procedure or of specimen collection(s) 观测值有关的时间或时间段：当报告的对象是研究对象时，通常是指手术时间或标本采集时间 样本(Diagnostic Report Specimen) Details about the specimens on which this diagnostic report is based 本诊断报告所依据样本的详细信息 图像(Diagnostic Report Media) A list of key images associated with this report. The images are generally created during the diagnostic process, and may be directly of the patient, or of treated specimens 与诊断报告有关的重要图像列：图像通常是在诊断过程中创建的，可以直接是研究对象的图像，也可以是治疗样本的图像 结果(Diagnostic Report Result) Observations that are part of this diagnostic report 作为诊断报告一部分的观察结果 结论(Conclusion Code) One or more codes that represent the summary conclusion (interpretation/impression) of the diagnostic report 以一个或多个代码来表示诊断报告的结论(解释/影响) 药物史(Medication) 药物代码(Medication Code) A code (or set of codes) that specify this medication, or a textual description if no code is available 指定药物的代码(或一组代码)或文本(无代码时) 药物形式(Medication Form) Describes the form of the item. Powder; tablets; capsule 描述药物的形式(粉末；片剂；胶囊) 用药量(Medication Amount) Specific amount of the drug in the packaged product. For example, when specifying a product that has the same strength (For example, Insulin glargine 100 unit per ml solution for injection), this attribute provides additional clarification of the package amount (For example, 3 ml, 10 ml, etc.) 包装产品中药物的具体量。例如当产品具有相同浓度(如100单位/ml注射溶液的甘精胰岛素)时，此属性提供了包装量的额外信息(如3 ml、10 ml等) 不良反应(Adverse Event) 事件(Event) This element defines the specific type of event that occurred or that was prevented from occurring 不良事件发生或被阻止发生的特定类型 日期(Date) The date (and perhaps time) when the adverse event occurred 不良事件发生的日期(和时间) 原因(Resulting Condition) Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical) 因接触某种物质(例如药物或化学品)而导致不良反应发生的相关信息 严重性(Severity) Describes the severity of the adverse event, in relation to the subject 与患者相关的不良反应的严重程度 结局(Outcome) Describes the type of outcome from the adverse event 不良反应导致的结果类型 标本(Specimen) 类型(Type) The kind of material that forms the specimen 构成标本的材料类型 采集源(Subject) Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device 标本的来源：可能来自于研究对象，来自于某个具体地点(如环境样本的来源)、物质或设备的采样 采集时间(Collection Duration) The span of time over which the collection of a specimen occurred 采集标本的时间 采集量(Specimen Collection Quantity) The quantity of specimen collected; for instance the volume of a blood sample, or the physical measurement of an anatomic pathology sample 采集的样本量(例如血液样本的体积或解剖病理样本的物理测量值) 采集方法(Method) A coded value specifying the technique that is used to perform the procedure 用于指定采样过程技术的编码值 观察(Observation) 医疗事件(Encounter) The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made 观察期间发生的医疗事件(例如患者和医疗保健提供者的相关互动) 观察码(Observation Code) Describes what was observed. Sometimes this is called the observation "name" 观察到的具体情况，有时也被称为“观察名称” 观察方法(Observation Method) Indicates the mechanism used to perform the observation 用于执行观察的具体机制 观察范围(Observation Reference Range) Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two reference Range elements would be used 通过与正常或推荐范围进行比较来解释相关数值的指南。多个参考范围使用时用“或”，即两个不同的目标群体需要使用两个观察范围值 问卷(QuestionnaireResponse) 问卷(Questionnaire) The Questionnaire that defines and organizes the questions for which answers are being provided 定义和组织问题(问题的答案已提供)的问卷 项目(Item) A group or question item from the original questionnaire for which answers are provided 提供答案的原始问卷中的一组或一个问题 回答(Item Answer) The respondent’s answer(s) to the question 回答者对问题的回答 CDASH 疾病史(MH) 病史报告(MHTERM) The reported or prespecified name of the medical condition or event 报告或预定会发生的疾病或医疗事件名称 疫病控制情况(MHCTRL) Indication whether the medical condition or event is under control at the time of data collection 指在数据收集时，疾病或医疗事件是否处于控制之下 疾病开始时间(MHSTDAT) The start date of medical history event or condition represented in an unambiguous date format 以明确的日期格式表示疾病或医疗事件的开始日期 疾病位置(MHLOC) A description of the anatomical location relevant for the medical condition or event 疾病或医疗事件有关的解剖位置 体格检查(PE) 分类(PECAT) A grouping of topic variable values based on user-defined characteristics 根据用户定义的特征进行的主题变量值分组 日期(PEDAT) The date when the physical examination was performed, represented in an unambiguous date format 以明确的日期格式表示进行体检的日期 结果(PERES) Overall assessment of examined body system 全身系统综合性评估 位置(ELOC) A description of the anatomical location of the subject relevant to the collection of physical examination 与体检有关的受试者解剖位置 方法(PEMETHOD) Method of the test or examination 测试或检查的方法 死亡详情(DD) 分类(DDCAT) A grouping of topic-variable values based on user-defined characteristics 根据用户定义的特征进行的主题变量值分组 日期(DTHDAT) Date of death for any subject who died 研究对象的死亡日期 死因(DDORRES) Result of the death detail assessment, as originally received or collected 最初收到或收集的死亡细节评估结果
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