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Evaluating the Impact of Health Care Data Completeness for Deep Generative Models. 评估医疗保健数据完整性对深度生成模型的影响。
IF 1.7 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Pub Date : 2023-05-01 DOI: 10.1055/a-2023-9181
Benjamin Smith, Senne Van Steelandt, Anahita Khojandi

Background: Deep generative models (DGMs) present a promising avenue for generating realistic, synthetic data to augment existing health care datasets. However, exactly how the completeness of the original dataset affects the quality of the generated synthetic data is unclear.

Objectives: In this paper, we investigate the effect of data completeness on samples generated by the most common DGM paradigms.

Methods: We create both cross-sectional and panel datasets with varying missingness and subset rates and train generative adversarial networks, variational autoencoders, and autoregressive models (Transformers) on these datasets. We then compare the distributions of generated data with original training data to measure similarity.

Results: We find that increased incompleteness is directly correlated with increased dissimilarity between original and generated samples produced through DGMs.

Conclusions: Care must be taken when using DGMs to generate synthetic data as data completeness issues can affect the quality of generated data in both panel and cross-sectional datasets.

背景:深度生成模型(dgm)为生成真实的合成数据以增强现有医疗保健数据集提供了一条有前途的途径。然而,原始数据集的完整性究竟如何影响生成的合成数据的质量尚不清楚。目的:在本文中,我们研究了数据完整性对最常见的DGM范式生成的样本的影响。方法:我们创建了具有不同缺失率和子集率的横截面和面板数据集,并在这些数据集上训练生成对抗网络、变分自编码器和自回归模型(transformer)。然后,我们将生成数据的分布与原始训练数据进行比较,以衡量相似性。结果:我们发现不完整性的增加与通过dgm产生的原始样品和生成样品之间的不相似性增加直接相关。结论:在使用dgm生成合成数据时必须小心,因为数据完整性问题会影响面板和横截面数据集生成数据的质量。
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引用次数: 0
Definition of a Practical Taxonomy for Referencing Data Quality Problems in Health Care Databases. 参考卫生保健数据库中数据质量问题的实用分类法的定义。
IF 1.7 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Pub Date : 2023-05-01 DOI: 10.1055/a-1976-2371
Paul Quindroit, Mathilde Fruchart, Samuel Degoul, Renaud Périchon, Julien Soula, Romaric Marcilly, Antoine Lamer

Introduction: Health care information systems can generate and/or record huge volumes of data, some of which may be reused for research, clinical trials, or teaching. However, these databases can be affected by data quality problems; hence, an important step in the data reuse process consists in detecting and rectifying these issues. With a view to facilitating the assessment of data quality, we developed a taxonomy of data quality problems in operational databases.

Material: We searched the literature for publications that mentioned "data quality problems," "data quality taxonomy," "data quality assessment," or "dirty data." The publications were then reviewed, compared, summarized, and structured using a bottom-up approach, to provide an operational taxonomy of data quality problems. The latter were illustrated with fictional examples (though based on reality) from clinical databases.

Results: Twelve publications were selected, and 286 instances of data quality problems were identified and were classified according to six distinct levels of granularity. We used the classification defined by Oliveira et al to structure our taxonomy. The extracted items were grouped into 53 data quality problems.

Discussion: This taxonomy facilitated the systematic assessment of data quality in databases by presenting the data's quality according to their granularity. The definition of this taxonomy is the first step in the data cleaning process. The subsequent steps include the definition of associated quality assessment methods and data cleaning methods.

Conclusion: Our new taxonomy enabled the classification and illustration of 53 data quality problems found in hospital databases.

简介:卫生保健信息系统可以生成和/或记录大量数据,其中一些数据可以用于研究、临床试验或教学。然而,这些数据库可能受到数据质量问题的影响;因此,数据重用过程中的一个重要步骤是检测和纠正这些问题。为了便于评估数据质量,我们制定了一套运行数据库中数据质量问题的分类。材料:我们搜索了提到“数据质量问题”、“数据质量分类”、“数据质量评估”或“脏数据”的出版物的文献。然后使用自底向上的方法对出版物进行审查、比较、总结和结构化,以提供数据质量问题的操作分类法。后者是用临床数据库中的虚构例子(尽管基于现实)来说明的。结果:选取了12篇出版物,确定了286个数据质量问题实例,并根据六个不同的粒度级别进行了分类。我们使用Oliveira等人定义的分类来构建我们的分类法。提取的项目被分为53个数据质量问题。讨论:这种分类法通过根据数据的粒度表示数据的质量,促进了对数据库中数据质量的系统评估。这个分类法的定义是数据清理过程中的第一步。后续步骤包括定义相关的质量评估方法和数据清理方法。结论:我们的新分类法能够对医院数据库中发现的53个数据质量问题进行分类和说明。
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引用次数: 1
High-Quality Data for Health Care and Health Research. 卫生保健和卫生研究的高质量数据。
IF 1.7 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Pub Date : 2023-05-01 DOI: 10.1055/a-2045-8287
Jürgen Stausberg, Sonja Harkener
In the 19th century, Florence Nightingale pointed to the importance of nursing documentation for the care of patients and the necessity of data-based statistics for quality improvement. The same century, John Snow projected his observations about patients with Cholera on a street map, laying the ground for modern epidemiological science. The historical examples demonstrate that proper data are the foundation of relevant information about individuals and of new scientific evidence. In the ideal case of Ackoff's pyramid, information, knowledge, understanding, and wisdom arise from data.
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引用次数: 0
The Digital Analytic Patient Reviewer (DAPR) for COVID-19 Data Mart Validation. COVID-19数据集市验证的数字分析患者审稿人(DAPR)。
IF 1.7 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Pub Date : 2022-12-01 DOI: 10.1055/a-1938-0436
Heekyong Park, Taowei David Wang, Nich Wattanasin, Victor M Castro, Vivian Gainer, Sergey Goryachev, Shawn Murphy

Objective: To provide high-quality data for coronavirus disease 2019 (COVID-19) research, we validated derived COVID-19 clinical indicators and 22 associated machine learning phenotypes, in the Mass General Brigham (MGB) COVID-19 Data Mart.

Methods: Fifteen reviewers performed a retrospective manual chart review for 150 COVID-19-positive patients in the data mart. To support rapid chart review for a wide range of target data, we offered a natural language processing (NLP)-based chart review tool, the Digital Analytic Patient Reviewer (DAPR). For this work, we designed a dedicated patient summary view and developed new 127 NLP logics to extract COVID-19 relevant medical concepts and target phenotypes. Moreover, we transformed DAPR for research purposes so that patient information is used for an approved research purpose only and enabled fast access to the integrated patient information. Lastly, we performed a survey to evaluate the validation difficulty and usefulness of the DAPR.

Results: The concepts for COVID-19-positive cohort, COVID-19 index date, COVID-19-related admission, and the admission date were shown to have high values in all evaluation metrics. However, three phenotypes showed notable performance degradation than the positive predictive value in the prepandemic population. Based on these results, we removed the three phenotypes from our data mart. In the survey about using the tool, participants expressed positive attitudes toward using DAPR for chart review. They assessed that the validation was easy and DAPR helped find relevant information. Some validation difficulties were also discussed.

Conclusion: Use of NLP technology in the chart review helped to cope with the challenges of the COVID-19 data validation task and accelerated the process. As a result, we could provide more reliable research data promptly and respond to the COVID-19 crisis. DAPR's benefit can be expanded to other domains. We plan to operationalize it for wider research groups.

目的:为了为2019冠状病毒病(COVID-19)研究提供高质量的数据,我们在麻省总医院(MGB) COVID-19数据集市中验证了衍生的COVID-19临床指标和22种相关机器学习表型。方法:对数据集市中150例covid -19阳性患者进行回顾性手工图表复习。为了支持对大范围目标数据的快速图表审查,我们提供了一个基于自然语言处理(NLP)的图表审查工具,数字分析患者审查(DAPR)。在这项工作中,我们设计了一个专门的患者总结视图,并开发了新的127 NLP逻辑来提取COVID-19相关的医学概念和目标表型。此外,我们将DAPR转换为研究目的,以便患者信息仅用于批准的研究目的,并支持快速访问集成的患者信息。最后,我们进行了一项调查来评估DAPR的验证难度和有用性。结果:COVID-19阳性队列、COVID-19索引日期、COVID-19相关入院、入院日期等概念在所有评价指标中均具有较高值。然而,与大流行前人群的阳性预测值相比,三种表型表现出显著的性能下降。基于这些结果,我们从数据集市中删除了这三种表型。在使用该工具的调查中,参与者对使用DAPR进行图表审查表达了积极的态度。他们认为验证很容易,DAPR帮助找到了相关信息。还讨论了一些验证困难。结论:在图表审核中使用NLP技术有助于应对COVID-19数据验证任务的挑战,并加快了流程。因此,我们可以及时提供更可靠的研究数据,应对COVID-19危机。DAPR的好处可以扩展到其他领域。我们计划将其应用于更广泛的研究小组。
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引用次数: 0
Self-Service Registry Log Builder: A Case Study in National Trauma Registry of Iran. 自助登记日志生成器:在伊朗国家创伤登记个案研究。
IF 1.7 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Pub Date : 2022-12-01 DOI: 10.1055/a-1911-9088
Mansoureh Yari Eili, Safar Vafadar, Jalal Rezaeenour, Mahdi Sharif-Alhoseini

Background: Although the process-mining algorithms have evolved in the past decade, the lack of attention to extracting event logs from raw data of databases in an automatic manner is evident. These logs are available in a process-oriented manner in the process-aware information systems. Still, there are areas where their extraction is a challenge to address (e.g., trauma registries).

Objective: The registry data are recorded manually and follow an unstructured ad hoc pattern; prone to high noises and errors; consequently, registry logs are classified at a maturity level of one, and extracting process-centric information is not a trivial task therein. The experiences made during the event log building from the trauma registry are the subjects to be studied.

Results: The result indicates that the three-phase self-service registry log builder tool can withstand the mentioned issues by filtering and enriching the raw data and making them ready for any level of process-mining analysis. This proposed tool is demonstrated through process discovery in the National Trauma Registry of Iran, and the encountered challenges and limitations are reported.

Conclusion: This tool is an interactive visual event log builder for trauma registry data and is freely available for studies involving other registries. In conclusion, future research directions derived from this case study are suggested.

背景:虽然过程挖掘算法在过去的十年中有了很大的发展,但显然缺乏对以自动方式从数据库原始数据中提取事件日志的关注。这些日志在流程感知信息系统中以面向流程的方式提供。尽管如此,仍有一些领域的提取是一个挑战(例如,创伤登记)。目的:注册表数据是手工记录的,遵循非结构化的临时模式;容易产生高噪声和误差;因此,注册中心日志按1级成熟度进行分类,提取以流程为中心的信息并不是一项微不足道的任务。在创伤登记处建立事件日志期间所获得的经验是研究的主题。结果:结果表明,通过过滤和丰富原始数据并使其为任何级别的流程挖掘分析做好准备,三相自助注册表日志构建器工具可以抵御上述问题。伊朗国家创伤登记处通过过程发现证明了这一建议的工具,并报告了所遇到的挑战和局限性。结论:该工具是创伤登记数据的交互式可视化事件日志生成器,可免费用于涉及其他登记的研究。最后,提出了今后的研究方向。
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引用次数: 1
An Intelligent Medical Isolation Observation Management System Based on the Internet of Things. 基于物联网的智能医学隔离观察管理系统
IF 1.7 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Pub Date : 2022-12-01 DOI: 10.1055/s-0042-1757185
Wensheng Sun, Chunmei Wang, Jimin Sun, Ziping Miao, Feng Ling, Guangsong Wu
<p><strong>Background: </strong>Since COVID-19 (coronavirus disease 2019) was discovered in December 2019, it has spread worldwide. Early isolation and medical observation management of cases and their close contacts are the key to controlling the spread of the epidemic. However, traditional medical observation requires medical staff to measure body temperature and other vital signs face to face and record them manually. There is a general shortage of human and personal protective equipment and a high risk of occupational exposure, which seriously threaten the safety of medical staff.</p><p><strong>Methods: </strong>We designed an intelligent crowd isolation medical observation management system framework based on the Internet of Things using wireless telemetry and big data cloud platform remote management technology. Through a smart wearable device with built-in sensors, vital sign data and geographical locations of medical observation subjects are collected and automatically uploaded to the big data monitoring platform on demand. According to the comprehensive analysis of the set threshold parameters, abnormal subjects are screened out, and activity tracking and health status monitoring for medical observation and management objectives are performed through monitoring and early warning management and post-event data traceability. In the trial of this system, the subjects wore the wristwatches designed in this study and real-time monitoring was conducted throughout the whole process. Additionally, for comparison, the traditional method was also used for these people. Medical staff came to measure their temperature twice a day. The subjects were 1,128 returned overseas Chinese from Europe.</p><p><strong>Results: </strong>Compared with the traditional vital sign detection method, the system designed in this study has the advantages of a fast response, low error, stability, and good endurance. It can monitor the temperature, pulse, blood pressure, and heart rate of the monitored subject in real time. The system designed in this study and the traditional vital sign detection method were both used to monitor 1,128 close contacts with COVID-19. There were six cases of abnormal body temperature that were missed by traditional manual temperature measurement in the morning and evening, and these six cases (0.53%) were sent to the hospital for further diagnosis. The abnormal body temperature of these six cases was not found in time when the medical staff came to check the temperature on a twice-a-day basis. The system designed in this study, however, can detect the abnormal body temperature of all these six people. The sensitivity and specificity of our system were both 100%.</p><p><strong>Conclusion: </strong>The system designed in this study can monitor the body temperature, blood oxygen, blood pressure, heart rate, and geographical location of the monitoring subject in real time. It can be extended to COVID-19 medical observation isolation points, shel
背景:自2019年12月发现COVID-19(冠状病毒病2019)以来,它已在全球传播。对病例及其密切接触者进行早期隔离和医学观察管理是控制疫情传播的关键。而传统的医学观察需要医务人员面对面测量体温等生命体征,并手工记录。人体和个人防护装备普遍短缺,职业接触的风险很高,严重威胁到医务人员的安全。方法:采用无线遥测和大数据云平台远程管理技术,设计了基于物联网的智能人群隔离医学观察管理系统框架。通过内置传感器的智能可穿戴设备,采集医学观察对象的生命体征数据和地理位置,并按需自动上传至大数据监控平台。根据设定的阈值参数综合分析,筛选出异常受试者,通过监测预警管理和事后数据溯源,实现医学观察管理目标的活动跟踪和健康状态监测。在本系统的试用中,受试者佩戴本研究设计的腕表,全程进行实时监测。此外,为了比较,对这些人也使用了传统的方法。医务人员每天来给他们量两次体温。研究对象为1128名欧洲归侨。结果:与传统的生命体征检测方法相比,本研究设计的系统具有响应速度快、误差小、稳定性好、耐久性好等优点。它可以实时监测被监测对象的体温、脉搏、血压和心率。采用本研究设计的系统和传统的生命体征检测方法对1128例新型冠状病毒密切接触者进行监测。传统的早晚人工测温漏诊6例体温异常,6例(0.53%)送院进一步诊断。这6例患者的体温异常,在医务人员每天两次上门检查体温时均未被及时发现。然而,本研究设计的系统可以检测到这六个人的异常体温。本系统的敏感性和特异性均为100%。结论:本研究设计的系统可以实时监测监测对象的体温、血氧、血压、心率和地理位置。可扩展到新冠肺炎医学观察隔离点、方舱医院、传染病病房、养老院等。
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引用次数: 0
Developing Automated Computer Algorithms to Phenotype Periodontal Disease Diagnoses in Electronic Dental Records. 在电子牙科记录中开发牙周病诊断表型的自动计算机算法。
IF 1.7 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Pub Date : 2022-12-01 DOI: 10.1055/s-0042-1757880
Jay Sureshbhai Patel, Ryan Brandon, Marisol Tellez, Jasim M Albandar, Rishi Rao, Joachim Krois, Huanmei Wu

Objective: Our objective was to phenotype periodontal disease (PD) diagnoses from three different sections (diagnosis codes, clinical notes, and periodontal charting) of the electronic dental records (EDR) by developing two automated computer algorithms.

Methods: We conducted a retrospective study using EDR data of patients (n = 27,138) who received care at Temple University Maurice H. Kornberg School of Dentistry from January 1, 2017 to August 31, 2021. We determined the completeness of patient demographics, periodontal charting, and PD diagnoses information in the EDR. Next, we developed two automated computer algorithms to automatically diagnose patients' PD statuses from clinical notes and periodontal charting data. Last, we phenotyped PD diagnoses using automated computer algorithms and reported the improved completeness of diagnosis.

Results: The completeness of PD diagnosis from the EDR was as follows: periodontal diagnosis codes 36% (n = 9,834), diagnoses in clinical notes 18% (n = 4,867), and charting information 80% (n = 21,710). After phenotyping, the completeness of PD diagnoses improved to 100%. Eleven percent of patients had healthy periodontium, 43% were with gingivitis, 3% with stage I, 36% with stage II, and 7% with stage III/IV periodontitis.

Conclusions: We successfully developed, tested, and deployed two automated algorithms on big EDR datasets to improve the completeness of PD diagnoses. After phenotyping, EDR provided 100% completeness of PD diagnoses of 27,138 unique patients for research purposes. This approach is recommended for use in other large databases for the evaluation of their EDR data quality and for phenotyping PD diagnoses and other relevant variables.

目的:我们的目的是通过开发两种自动计算机算法,从电子牙科记录(EDR)的三个不同部分(诊断代码、临床记录和牙周图表)对牙周病(PD)诊断进行表型分析。方法:我们对2017年1月1日至2021年8月31日在天普大学Maurice H. Kornberg牙科学院接受治疗的患者(n = 27138)的EDR数据进行了回顾性研究。我们确定了EDR中患者人口统计学、牙周图表和PD诊断信息的完整性。接下来,我们开发了两种自动计算机算法,根据临床记录和牙周图表数据自动诊断患者的PD状态。最后,我们使用自动计算机算法对PD诊断进行表型分析,并报告了诊断完整性的提高。结果:EDR诊断PD的完整性如下:牙周诊断代码36% (n = 9834),临床记录诊断18% (n = 4867),图表信息80% (n = 21710)。表型分析后,PD诊断的完整性提高到100%。11%的患者牙周组织健康,43%患有牙龈炎,3%为I期,36%为II期,7%为III/IV期牙周炎。结论:我们在大型EDR数据集上成功开发、测试并部署了两种自动化算法,以提高PD诊断的完整性。在进行表型分型后,EDR为研究目的提供了27138例独特患者PD诊断的100%完整性。该方法被推荐用于其他大型数据库,以评估其EDR数据质量,并对PD诊断和其他相关变量进行表型分析。
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引用次数: 1
Medical Text Prediction and Suggestion Using Generative Pretrained Transformer Models with Dental Medical Notes. 基于牙科医疗记录的生成式预训练变压器模型的医学文本预测和建议。
IF 1.7 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Pub Date : 2022-12-01 DOI: 10.1055/a-1900-7351
Joseph Sirrianni, Emre Sezgin, Daniel Claman, Simon L Linwood

Background: Generative pretrained transformer (GPT) models are one of the latest large pretrained natural language processing models that enables model training with limited datasets and reduces dependency on large datasets, which are scarce and costly to establish and maintain. There is a rising interest to explore the use of GPT models in health care.

Objective: We investigate the performance of GPT-2 and GPT-Neo models for medical text prediction using 374,787 free-text dental notes.

Methods: We fine-tune pretrained GPT-2 and GPT-Neo models for next word prediction on a dataset of over 374,000 manually written sections of dental clinical notes. Each model was trained on 80% of the dataset, validated on 10%, and tested on the remaining 10%. We report model performance in terms of next word prediction accuracy and loss. Additionally, we analyze the performance of the models on different types of prediction tokens for categories. For comparison, we also fine-tuned a non-GPT pretrained neural network model, XLNet (large), for next word prediction. We annotate each token in 100 randomly sampled notes by category (e.g., names, abbreviations, clinical terms, punctuation, etc.) and compare the performance of each model by token category.

Results: Models present acceptable accuracy scores (GPT-2: 76%; GPT-Neo: 53%), and the GPT-2 model also performs better in manual evaluations, especially for names, abbreviations, and punctuation. Both GPT models outperformed XLNet in terms of accuracy. The results suggest that pretrained models have the potential to assist medical charting in the future. We share the lessons learned, insights, and suggestions for future implementations.

Conclusion: The results suggest that pretrained models have the potential to assist medical charting in the future. Our study presented one of the first implementations of the GPT model used with medical notes.

背景:生成式预训练转换器(GPT)模型是一种最新的大型预训练自然语言处理模型,它可以使用有限的数据集进行模型训练,并减少对大型数据集的依赖,而大型数据集的建立和维护成本很高。人们对探索GPT模型在医疗保健中的应用越来越感兴趣。目的:研究GPT-2和GPT-Neo模型对374,787份自由文本牙科笔记进行医学文本预测的性能。方法:我们对预训练的GPT-2和GPT-Neo模型进行微调,以在超过37.4万份牙科临床笔记的人工部分数据集中进行下一个单词预测。每个模型在80%的数据集上进行训练,在10%的数据集上进行验证,并在剩下的10%上进行测试。我们根据下一个单词预测的准确性和损失来报告模型的性能。此外,我们还分析了模型在不同类型的类别预测令牌上的性能。为了进行比较,我们还对非gpt预训练的神经网络模型XLNet(大)进行了微调,用于下一个单词预测。我们按类别(例如,名称,缩写,临床术语,标点符号等)在100个随机抽样的音符中注释每个标记,并按标记类别比较每个模型的性能。结果:模型呈现出可接受的准确度分数(GPT-2: 76%;GPT-Neo: 53%),并且GPT-2模型在手动评估中也表现更好,特别是在名称、缩写和标点符号方面。两种GPT模型在准确性方面都优于XLNet。结果表明,预训练模型有可能在未来协助医疗制图。我们将分享经验教训、见解和对未来实现的建议。结论:预训练模型具有辅助医学制图的潜力。我们的研究是第一个将GPT模型用于医疗记录的实现之一。
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引用次数: 2
3LGM2IHE: Requirements for Data-Protection-Compliant Research Infrastructures-A Systematic Comparison of Theory and Practice-Oriented Implementation. [3] lgm2ihe:符合数据保护要求的研究基础设施——理论与面向实践的系统比较。
IF 1.7 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Pub Date : 2022-12-01 DOI: 10.1055/a-1950-2791
Robert Gött, Sebastian Stäubert, Alexander Strübing, Alfred Winter, Angela Merzweiler, Björn Bergh, Knut Kaulke, Thomas Bahls, Wolfgang Hoffmann, Martin Bialke

Objectives: The TMF (Technology, Methods, and Infrastructure for Networked Medical Research) Data Protection Guide (TMF-DP) makes path-breaking recommendations on the subject of data protection in research projects. It includes comprehensive requirements for applications such as patient lists, pseudonymization services, and consent management services. Nevertheless, it lacks a structured, categorized list of requirements for simplified application in research projects and systematic evaluation. The 3LGM2IHE ("Three-layer Graphbased meta model - Integrating the Healthcare Enterprise [IHE] " ) project is funded by the German Research Foundation (DFG). 3LGM2IHE aims to define modeling paradigms and implement modeling tools for planning health care information systems. In addition, one of the goals is to create and publish 3LGM2 information system architecture design patterns (short "design patterns") for the community as design models in terms of a framework. A structured list of data protection-related requirements based on the TMF-DP is a precondition to integrate functions (3LGM2 Domain Layer) and building blocks (3LGM2 Logical Tool Layer) in 3LGM2 design patterns.

Methods: In order to structure the continuous text of the TMF-DP, requirement types were defined in a first step. In a second step, dependencies and delineations of the definitions were identified. In a third step, the requirements from the TMF-DP were systematically extracted. Based on the identified lists of requirements, a fourth step included the comparison of the identified requirements with exemplary open source tools as provided by the "Independent Trusted Third Party of the University Medicine Greifswald" (TTP tools).

Results: As a result, four lists of requirements were created, which contain requirements for the "patient list", the "pseudonymization service", and the "consent management", as well as cross-component requirements from the TMF-DP chapter 6 in a structured form. Further to requirements (1), possible variants (2) of implementations (to fulfill a single requirement) and recommendations (3) were identified. A comparison of the requirements lists with the functional scopes of the open source tools E-PIX (record linkage), gPAS (pseudonym management), and gICS (consent management) has shown that these fulfill more than 80% of the requirements.

Conclusions: A structured set of data protection-related requirements facilitates a systematic evaluation of implementations with respect to the fulfillment of the TMF-DP guidelines. These re-usable lists provide a decision aid for the selection of suitable tools for new research projects. As a result, these lists form the basis for the development of data protection-related 3LGM2 design patterns as part of the 3LGM2IHE project.

目标:TMF(网络医学研究的技术、方法和基础设施)数据保护指南(TMF- dp)就研究项目中的数据保护主题提出了开创性的建议。它包括对患者名单、假名服务和同意管理服务等应用程序的全面需求。然而,它缺乏一个结构化的、分类的需求清单,以简化研究项目的应用和系统的评估。3LGM2IHE(“基于三层图的元模型-集成医疗保健企业[IHE]”)项目由德国研究基金会(DFG)资助。3LGM2IHE旨在定义建模范例并实现规划医疗保健信息系统的建模工具。此外,目标之一是为社区创建和发布3LGM2信息系统体系结构设计模式(简称“设计模式”),作为框架方面的设计模型。基于TMF-DP的数据保护相关需求的结构化列表是在3LGM2设计模式中集成功能(3LGM2域层)和构建块(3LGM2逻辑工具层)的先决条件。方法:为了构造TMF-DP的连续文本,首先定义需求类型。在第二步中,确定了定义的依赖关系和描述。在第三步中,系统地提取来自TMF-DP的需求。基于已确定的需求列表,第四步包括将已确定的需求与“University Medicine Greifswald的独立可信第三方”(TTP工具)提供的示范性开源工具进行比较。结果:创建了四个需求列表,其中包含“患者列表”,“假名服务”和“同意管理”的需求,以及TMF-DP第6章中以结构化形式的跨组件需求。除了需求(1)之外,还确定了实现的可能变体(2)(以满足单个需求)和建议(3)。将需求列表与开源工具E-PIX(记录链接)、gPAS(假名管理)和gICS(同意管理)的功能范围进行比较表明,这些工具满足了80%以上的需求。结论:一组结构化的数据保护相关需求有助于对TMF-DP指南的实现进行系统评估。这些可重复使用的列表为新研究项目选择合适的工具提供了决策辅助。因此,作为3LGM2IHE项目的一部分,这些列表构成了开发与数据保护相关的3LGM2设计模式的基础。
{"title":"3LGM2IHE: Requirements for Data-Protection-Compliant Research Infrastructures-A Systematic Comparison of Theory and Practice-Oriented Implementation.","authors":"Robert Gött,&nbsp;Sebastian Stäubert,&nbsp;Alexander Strübing,&nbsp;Alfred Winter,&nbsp;Angela Merzweiler,&nbsp;Björn Bergh,&nbsp;Knut Kaulke,&nbsp;Thomas Bahls,&nbsp;Wolfgang Hoffmann,&nbsp;Martin Bialke","doi":"10.1055/a-1950-2791","DOIUrl":"https://doi.org/10.1055/a-1950-2791","url":null,"abstract":"<p><strong>Objectives: </strong>The TMF (Technology, Methods, and Infrastructure for Networked Medical Research) Data Protection Guide (TMF-DP) makes path-breaking recommendations on the subject of data protection in research projects. It includes comprehensive requirements for applications such as patient lists, pseudonymization services, and consent management services. Nevertheless, it lacks a structured, categorized list of requirements for simplified application in research projects and systematic evaluation. The 3LGM2IHE (\"Three-layer Graphbased meta model - Integrating the Healthcare Enterprise [IHE] \" ) project is funded by the German Research Foundation (DFG). 3LGM2IHE aims to define modeling paradigms and implement modeling tools for planning health care information systems. In addition, one of the goals is to create and publish 3LGM<sup>2</sup> information system architecture design patterns (short \"design patterns\") for the community as design models in terms of a framework. A structured list of data protection-related requirements based on the TMF-DP is a precondition to integrate functions (3LGM<sup>2</sup> Domain Layer) and building blocks (3LGM<sup>2</sup> Logical Tool Layer) in 3LGM<sup>2</sup> design patterns.</p><p><strong>Methods: </strong>In order to structure the continuous text of the TMF-DP, requirement types were defined in a first step. In a second step, dependencies and delineations of the definitions were identified. In a third step, the requirements from the TMF-DP were systematically extracted. Based on the identified lists of requirements, a fourth step included the comparison of the identified requirements with exemplary open source tools as provided by the \"Independent Trusted Third Party of the University Medicine Greifswald\" (TTP tools).</p><p><strong>Results: </strong>As a result, four lists of requirements were created, which contain requirements for the \"patient list\", the \"pseudonymization service\", and the \"consent management\", as well as cross-component requirements from the TMF-DP chapter 6 in a structured form. Further to requirements (1), possible variants (2) of implementations (to fulfill a single requirement) and recommendations (3) were identified. A comparison of the requirements lists with the functional scopes of the open source tools E-PIX (record linkage), gPAS (pseudonym management), and gICS (consent management) has shown that these fulfill more than 80% of the requirements.</p><p><strong>Conclusions: </strong>A structured set of data protection-related requirements facilitates a systematic evaluation of implementations with respect to the fulfillment of the TMF-DP guidelines. These re-usable lists provide a decision aid for the selection of suitable tools for new research projects. As a result, these lists form the basis for the development of data protection-related 3LGM<sup>2</sup> design patterns as part of the 3LGM2IHE project.</p>","PeriodicalId":49822,"journal":{"name":"Methods of Information in Medicine","volume":"61 S 02","pages":"e134-e148"},"PeriodicalIF":1.7,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d1/2e/10-1055-a-1950-2791.PMC9788907.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9259948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development and Testing Requirements for an Integrated Maternal and Child Health Information System in Iran: A Design Thinking Case Study. 伊朗综合妇幼保健信息系统的开发和测试要求:设计思维案例研究。
IF 1.7 4区 医学 Q3 COMPUTER SCIENCE, INFORMATION SYSTEMS Pub Date : 2022-12-01 DOI: 10.1055/a-1860-8618
Zahra Meidani, Alireza Moravveji, Shirin Gohari, Hamideh Ghaffarian, Sahar Zare, Fatemeh Vaseghi, Gholam Abbas Moosavi, Ali Mohammad Nickfarjam, Felix Holl

Background: Management of child health care can be negatively affected by incomplete recording, low data quality, and lack of data integration of health management information systems to support decision making and public health program needs. Given the importance of identifying key determinants of child health via capturing and integrating accurate and high-quality information, we aim to address this gap through the development and testing requirements for an integrated child health information system.

Subjects and methods: A five-phase design thinking approach including empathizing, defining, ideation, prototyping, and testing was applied. We employed observations and interviews with the health workers at the primary health care network to identify end-users' challenges and needs using tools in human-centered design and focus group discussion. Then, a potential solution to the identified problems was developed as an integrated maternal and child health information system (IMCHIS) prototype and tested using Software Quality Requirements and Evaluation Model (SQuaRE) ISO/IEC 25000.

Results: IMCHIS was developed as a web-based system with 74 data elements and seven maternal and child health care requirements. The requirements of "child disease" with weight (0.26), "child nutrition" with weight (0.20), and "prenatal care" with weight (0.16) acquired the maximum weight coefficient. In the testing phase, the highest score with the weight coefficient of 0.48 and 0.73 was attributed to efficiency and functionality characteristics, focusing on software capability to fulfill the tasks that meet users' needs.

Conclusion: Implementing a successful child health care system integrates both maternal and child health care information systems to track the effect of maternal conditions on child health and support managing performance and optimizing service delivery. The highest quality score of IMCHIS in efficiency and functionality characteristics confirms that it owns the capability to identify key determinants of child health.

背景:记录不完整、数据质量低、缺乏卫生管理信息系统数据集成以支持决策和公共卫生计划需求,可能会对儿童卫生保健管理产生负面影响。鉴于通过获取和整合准确和高质量的信息来确定儿童健康的关键决定因素的重要性,我们的目标是通过开发和测试综合儿童健康信息系统的要求来解决这一差距。研究对象和方法:采用五阶段设计思维方法,包括移情、定义、构思、原型设计和测试。我们对初级卫生保健网络的卫生工作者进行了观察和访谈,利用以人为本的设计和焦点小组讨论工具确定最终用户的挑战和需求。然后,开发了一个潜在的解决方案,作为综合妇幼保健信息系统(IMCHIS)原型,并使用软件质量要求和评估模型(SQuaRE) ISO/IEC 25000进行了测试。结果:IMCHIS是一个基于网络的系统,包含74个数据元素和7项妇幼保健要求。“儿童疾病”需求与体重(0.26)、“儿童营养”需求与体重(0.20)、“产前护理”需求与体重(0.16)获得最大的体重系数。在测试阶段,效率和功能特征得分最高,权重系数分别为0.48和0.73,侧重于软件完成满足用户需求的任务的能力。结论:一个成功的儿童卫生保健系统的实施整合了孕产妇和儿童卫生保健信息系统,以跟踪孕产妇病情对儿童健康的影响,并支持管理绩效和优化服务提供。儿童健康信息系统在效率和功能特征方面的最高质量分数证实,它有能力确定儿童健康的关键决定因素。
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引用次数: 1
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Methods of Information in Medicine
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