“器械”域用来记录就诊居民暴露于外来物理对象或仪器的信息，即通过非化学作用的机制用于诊断或治疗目的的物质暴露信息。器械包括可植入物（例如心脏起搏器，支架，人工关节），医疗器械和用品（例如绷带，拐杖，注射器），医疗程序中使用的其他器械（例如缝合线，除颤器）和临床护理中使用的材料（例如粘合剂，基质，牙科材料，手术材料）。
The 'Device' domain captures information about a person's exposure to a foreign physical object or instrument which is used for diagnostic or therapeutic purposes through a mechanism beyond chemical action. Devices include implantable objects (e.g. pacemakers, stents, artificial joints), medical equipment and supplies (e.g. bandages, crutches, syringes), other instruments used in medical procedures (e.g. sutures, defibrillators) and material used in clinical care (e.g. adhesives, body material, dental material, surgical material).
| Field | Required | Type | Description | 描述 |
|---|---|---|---|---|
| device_exposure_id | Yes | bigint | A system-generated unique identifier for each Device Exposure. | 系统生成的，每个器械暴露的唯一标识符。 |
| person_id | Yes | bigint | A foreign key identifier to the Person who is subjected to the Device. The demographic details of that Person are stored in the PERSON table. | 外键，标识受器械影响的居民。该居民的人口统计信息存储在PERSON表中。 |
| device_concept_id | Yes | integer | A foreign key that refers to a Standard Concept identifier in the Standardized Vocabularies belonging to the 'Device' domain. | 外键，指向标准词汇表中属于“器械”域的标准概念标识符。 |
| device_exposure_start_date | No | date | The date the Device or supply was applied or used. | 使用器械或耗材的日期。 |
| device_exposure_start_datetime | Yes | datetime | The date and time the Device or supply was applied or used. | 使用器械或耗材的日期和时间。 |
| device_exposure_end_date | No | date | The date use of the Device or supply was ceased. | 使用器械或耗材的截止日期。 |
| device_exposure_end_datetime | No | datetime | The date and time use of the Device or supply was ceased. | 使用器械或耗材的截止日期和时间。 |
| device_type_concept_id | Yes | integer | A foreign key to the predefined Concept identifier in the Standardized Vocabularies reflecting the type of Device Exposure recorded. It indicates how the Device Exposure was represented in the source data and belongs to the 'Device Type' domain. | 外键，指向标准词汇表中预定义概念，标识记录的器械暴露类型。指的是器械暴露信息在源数据中的元数据字段，属于“器械类型”域。 |
| unique_device_id | No | varchar(50) | A UDI or equivalent identifying the instance of the Device used in the Person. | 该居民使用的器械相应的UDI或其他设备标识码。 |
| quantity | No | integer | The number of individual Devices used in the exposure. | 器械暴露的数量。（例如X光 3次，或者敷料 2单位） |
| provider_id | No | integer | A foreign key to the provider in the PROVIDER table who initiated or administered the Device. | 外键，指向PROVIDER表中记录的执行或者建议执行该器械暴露的贡献者。（例如开医嘱的医生或者拍片的技师） |
| visit_occurrence_id | No | integer | A foreign key to the visit in the VISIT_OCCURRENCE table during which the Device was used. | 外键，指向VISIT_OCCURRENCE表中，该次器械暴露对应的就诊信息。 |
| visit_detail_id | No | integer | A foreign key to the visit detail record in the VISIT_DETAIL table during which the Device was used. | 外键，指向VISIT_DETAIL中，该次器械暴露对应的就诊信息。 |
| device_source_value | No | varchar(50) | The source code for the Device as it appears in the source data. This code is mapped to a Standard Device Concept in the Standardized Vocabularies and the original code is stored here for reference. | 在源数据中记录的器械的源代码。此代码已映射到标准化词汇表中的标准器械概念，原始代码存储在此处以供参考。 |
| device_source_concept_id | Yes | integer | A foreign key to a Device Concept that refers to the code used in the source. | 外键，指向源数据中标识器械概念的代码。 |
共识
| No. | Convention Description | 共识 |
|---|---|---|
| 1 | The distinction between Devices or supplies and Procedures are sometimes blurry, but the former are physical objects while the latter are actions, often to apply a Device or supply. | 器械耗材与操作之间的区别有时是模糊的，但前者是物理对象，而后者是动作行为，通常是使用器械或耗材。 |
| 2 | For medical devices that are regulated by the FDA, a Unique Device Identification (UDI) is provided if available in the data source and is recorded in the UNIQUE_DEVICE_ID field. | 对于受FDA监管的医疗器械，如果在数据源中可用，则提供唯一器械标识（UDI），并记录在UNIQUE_DEVICE_ID字段中。 |
| 3 | Valid Device Concepts belong to the 'Device' domain. The Concepts of this domain are derived from the DI portion of a UDI or based on other source vocabularies, like HCPCS. | “器械”域的概念对记录器械是有效的。该域的概念源自UDI的DI部分或基于其他源词汇表，如HCPCS。 |
| 4 | A Device Type is assigned to each Device Exposure to track from what source the information was drawn or inferred. The valid vocabulary for these Concepts is 'Device Type'. | 为每个器械暴露分配器械类型，以跟踪从哪个源数据采集的信息以及推断信息的隐含概念。“器械类型”是这些概念的有效词汇。 |
| 5 | The Visit during which the Device was first used is recorded through a reference to the VISIT_OCCURRENCE table. | 通过对VISIT_OCCURRENCE表关联，来记录首次使用该器械的就诊信息。 |
| 6 | The Visit Detail during which the Device was first used is recorded through a reference to the VISIT_DETAIL table. | 通过对VISIT_DETAIL表关联，来记录首次使用该器械的就诊详细信息。 |
| 7 | The Provider exposing the patient to the Device is recorded through a reference to the PROVIDER table. | 通过对PROVIDER表关联，来记录执行或推荐执行该器械暴露的贡献者。 |
| 8 | When dealing with duplicate records, the ETL must determine whether to sum them up into one record or keep them separate. Things to consider are:Same Device/ProcedureSame DEVICE_EXPOSURE_START_DATETIMESame Visit Occurrence or Visit DetailSame ProviderSame Modifier for ProceduresSame COST_IDTHEMIS issue #27 | ETL时，必须确定是将重复记录处理合并为一条记录，还是将它们分开。需要考虑的事项是：相同的器械/操作，相同的DEVICE_EXPOSURE_START_DATETIME，相同的就诊事件，相同的就诊详细信息，相同的贡献者，相同的操作限定词，相同的费用ID主题＃27 |
| 9 | If a Device Exposure has a quantity of '0' in the source, this should default to '1' in the ETL. If there is a record in the source it can be assumed the exposure occurred at least once (THEMIS issue #26). | 如果器械暴露在源数据中的数量为“0”，则ETL中默认处理为“1”。如果源数据中有任何该器械记录，则可以假设该器械至少暴露过1次（THEMIS问题＃26) |
本系列在介绍目前世界上最适用于临床科研+卫生经济学的标准医疗大数据格式（未经严谨考证，但有相关研究发表在专业期刊上），俨然是真实世界研究方案里面最接进成熟的基础建设方案。感兴趣的介绍请移步B站观看视频。
OHDSI——观察性健康医疗数据科学与信息学，是一个世界性的公益型非盈利研究联盟，主要研究全方位医学大数据分析的开源解决方案，旨在通过大规模数据分析和挖掘来提升临床医学数据价值，实现跨学科、跨行业的多方合作。目前，目前，已有来自美国、加拿大、澳大利亚、英国等几十个国家地区的上百个组织机构，高校，医院和公司企业参与了OHDSI全球协作网络，如斯坦福、哈佛、杜克大学医学院，强生、诺华、甲骨文、IBM公司，拥有超过6亿人口的临床数据规模，累计协作研究发表了上百篇论文。
我们在这里邀请国内对相关工作感兴趣、愿共同学习的好学人士参与到中文兴趣小组，互通有无，一起弥补跨行业、跨学科的知识积累。前期主要以对OHDSI在github上的开源工作进行翻译、交流、学习为主，并会对医疗大数据、医学统计学、生物信息学等学科知识建立学习互助、互督的机制。有兴趣的请看文档，微信群二维码在内：OHDSI中文兴趣小组共识&OHDSI介绍
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