OBJECTIVES: A clinical data warehouse (CDW) is part of our hospital information system, and it provides user-friendly ‘data search and extraction’ interfaces for query composition. We carried out a risk factor analysis for the extended use of opioids after coronary artery bypass grafting (CABG), taking advantage of the CDW system. METHODS: From 2015 to 2017, clinical data from 461 patients who had undergone either isolated or concomitant CABG were extracted using the CDW; the extracted data included baseline patient characteristics, various examination results, and opioid prescription information. Supplementary data that could not be extracted with the CDW were collected via manual review of the electronic medical records. RESULTS: Data from a total of 447 patients were analyzed finally. The mean patient age was 66.8 ± 10.9 years, 332 patients (74%) were male, and 235 patients (53%) had diabetes. Among the 447 patients, 90 patients (20.1%) took some type of opioid at the 15th postoperative day. An oral rapid-acting agent was the most frequently used opioid (83%). In the risk factor analysis for extended opioid use, duration of operation was the only significant risk factor (odds ratio = 1.004; 95% confidence interval, 1.001–1.007; p = 0.008). CONCLUSIONS: Longer operation time was associated with the risk of extended opioid use after CABG. CDW was a helpful tool for extracting mass clinical data rapidly, but to maximize its utility, the data should be checked carefully as they are entered in the system so that post-processing can be minimized. Further refinement of the clinical data input and output interface is warranted.
Analgesics, Opioid ; Coronary Artery Bypass ; Coronary Vessels ; Database Management Systems ; Electronic Health Records ; Hospital Information Systems ; Humans ; Male ; Prescriptions ; Risk Factors

OBJECTIVES: Long-term follow-up care after total joint arthroplasty is essential to evaluate hip and knee arthroplasty outcomes, to provide information to physicians and improve arthroplasty performance, and to improve patients' health condition. In this paper, we aim to improve the communication between arthroplasty patients and physicians and to reduce the cost of follow-up controls based on mobile application technologies and cloud computing. METHODS: We propose a mobile-based healthcare system that provides cost-effective follow-up controls for primary arthroplasty patients through questions about symptoms in the replaced joint, questionnaires (WOMAC and SF-36v2) and the radiological examination of knee or hip joint. We also perform a cost analysis for a set of 423 patients that were treated in the University Clinic for Orthopedics in Essen-Werden. RESULTS: The estimation of healthcare costs shows significant cost savings (a reduction of 63.67% for readmission rate 5%) in both the University Clinic for Orthopedics in Essen-Werden and the state of North Rhine-Westphalia when the mobile-based healthcare system is applied. CONCLUSIONS: We propose a mHealth system to reduce the cost of follow-up assessments of arthroplasty patients through evaluation of diagnosis, self-monitoring, and regular review of their health status.
Arthroplasty* ; Arthroplasty, Replacement ; Arthroplasty, Replacement, Knee ; Cloud Computing ; Cost Savings ; Cost-Benefit Analysis ; Costs and Cost Analysis ; Database Management Systems ; Delivery of Health Care* ; Diagnosis ; Follow-Up Studies* ; Health Care Costs ; Hip ; Hip Joint ; Humans ; Joints* ; Knee ; Mobile Applications ; Orthopedics ; Telemedicine

Establishment of quality management system (QMS) plays a critical role in the clinical data management (CDM). The objectives of CDM are to ensure the quality and integrity of the trial data. Thus, every stage or element that may impact the quality outcomes of clinical studies should be in the controlled manner, which is referred to the full life cycle of CDM associated with the data collection, handling and statistical analysis of trial data. Based on the QMS, this paper provides consensus on how to develop a compliant clinical data management plan (CDMP). According to the essential requirements of the CDM, the CDMP should encompass each process of data collection, data capture and cleaning, medical coding, data verification and reconciliation, database monitoring and management, external data transmission and integration, data documentation and data quality assurance and so on. Creating and following up data management plan in each designed data management steps, dynamically record systems used, actions taken, parties involved will build and confirm regulated data management processes, standard operational procedures and effective quality metrics in all data management activities. CDMP is one of most important data management documents that is the solid foundation for clinical data quality.
Clinical Trials as Topic ; Data Collection ; standards ; Database Management Systems ; standards ; Information Storage and Retrieval ; standards

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.
Clinical Trials as Topic ; Database Management Systems ; standards ; Information Storage and Retrieval ; standards ; Software Validation

The big-data era has arrived, which involves all professions and trades. Its impact on the medical field has gradually revealed. With the characteristics of big data "4V" (volume, velocity, variety, value) and its theory generality with TCM (holistic thinking, correlativity) as well as regularity of disease development, combined with present status of acupuncture clinical research, the influences of big-data era on trial design, data collection, analysis and sharing of acupuncture clinical research are discussed in this paper, aiming to provide references for solving the difficulties of study design and determining the future research direction of acupuncture clinical research.
Acupuncture Therapy ; Biomedical Research ; Clinical Trials as Topic ; Database Management Systems ; Humans ; Medicine, Chinese Traditional

The aim of this study was to develop the data element standard directory of traditional Chinese medicine (TCM) clinical pharmacy information, to provide application standards and models of TCM clinical pharmacy for the electronic medical record (EMR). The developed line of work is as follows: initially establish research through four forms: literature analysis, questionnaires, discussion groups, expert advice. The research range from the Chinese herbal medicine research, herbal origin, harvesting, processing, identification of traits, physical and chemical identification, modern research, character, taste, Indications, clinical application, processing, dispensing medicine, Chinese medicine specifications, usage, dosage, caution, efficacy indications to small packaging applications, drug research, management and other related issues, including traditional Chinese medicine theory, application and hospital management information; according to the general and part 16 content of the national "Health Information Data Element Standards", and the basic method of extracting data element to study and develop the data element of TCM clinical pharmacy information from the defining content. Correspondingly propose the ideas and methods of construction of the "Data Element Standard Directory of TCM Clinical Pharmacy Information", sort out medicine clinical information data element standard catalog, divided into basic categories, clinical application class, management class three parts, and set norms and standards of identifying data elements, definitions, allowable value of traditional Chinese medicine clinical information, and discuss the sources and standards of information collection, leaving the interface, standardized and scientific terminology, docking with the existing standards, maintenance and management program and oter issues.
China ; Data Mining ; methods ; statistics & numerical data ; Database Management Systems ; standards ; statistics & numerical data ; Electronic Health Records ; standards ; statistics & numerical data ; Evidence-Based Medicine ; methods ; statistics & numerical data ; Humans ; Information Dissemination ; methods ; Medicine, Chinese Traditional ; methods ; Phytotherapy ; methods ; statistics & numerical data

RIA(Rich Internet Applications) have highly interactive, rich user experience and powerful clients. Based on introducing the concept, features, and technology platform of the RIA technology, we proposed that RIA should be the highest priority in hospital medical equipment management information system construction.
Database Management Systems ; Internet ; instrumentation ; Maintenance and Engineering, Hospital ; methods ; Software

In order to optimize the data flow of subject datasets and to establish the service platform of medical image data, we developed a medical image database aiming at subject service of clinic research. Firstly, a novel integrated infrastructure was designed, which was based on the requirements of database system and the survey of data resource. Then, several standards and technologies had been used in the construction of this novel system, including "Subject dataset-Sample data-Image files" three-ties image information framework, DICOM-based data processing, Index & file hybrid structure of file management strategy, etc. The new system has been successfully deployed in our test-bed and has got satisfactory results.
Database Management Systems ; Databases, Factual ; standards ; Diagnostic Imaging ; Image Processing, Computer-Assisted ; Radiology Information Systems ; instrumentation

OBJECTIVES: The purpose of this study was to design an integrated data management system based on the POCT1-A2, LIS2-A, LIS2-A2, and HL7 standard to ensure data interoperability between mobile equipment, such as point-of-care testing equipment and the existing hospital data system, its efficiency was also evaluated. METHODS: The method of this study was intended to design and realize a data management system which would provide a solution for the problems that occur when point-of-care testing equipment is introduced to existing hospital data, after classifying such problems into connectivity, integration, and interoperability. This study also checked if the data management system plays a sufficient role as a bridge between the point-of-care testing equipment and the hospital information system through connection persistence and reliability testing, as well as data integration and interoperability testing. RESULTS: In comparison with the existing system, the data management system facilitated integration by improving the result receiving time, improving the collection rate, and by enabling the integration of disparate types of data into a single system. And it was found out that we can solve the problems related to connectivity, integration and interoperability through generating the message in standardized types. CONCLUSIONS: It is expected that the proposed data management system, which is designed to improve the integration point-of-care testing equipment with existing systems, will establish a solid foundation on which better medical service may be provided by hospitals by improving the quality of patient service.
Clinical Laboratory Information Systems ; Database Management Systems ; Dietary Sucrose ; Hospital Information Systems ; Humans ; Information Systems ; Medical Order Entry Systems ; Point-of-Care Systems

In this paper, ethical principles and practice guidelines concerning the usage of public database for medical researches were developed and proposed. Although there are several personal health databases with comprehensive information of each individual, researches aiming at public good are often hindered because of legal, managerial and technical barriers to the usage of public databases. Ethical principles and guidelines are indispensible to promote medical research that will benefit society while protecting personal information from bleaching and abuse. These principles and guidelines should be a basis of trust and supports from society. For this purpose, the meaning of public good was given, and the current status of the linkage and usage of public databases were explored. As a result, three ethical principles-guaranteeing public good, protecting personal information, and transparency were established and eight recommendations were proposed.
Codes of Ethics ; Database Management Systems ; Ethics, Medical ; Humans ; Medical Record Linkage