PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-25 (1178174)

Clipboard (0)
None

Related Articles

1.  Design and Applications of a Multimodality Image Data Warehouse Framework 
A comprehensive data warehouse framework is needed, which encompasses imaging and non-imaging information in supporting disease management and research. The authors propose such a framework, describe general design principles and system architecture, and illustrate a multimodality neuroimaging data warehouse system implemented for clinical epilepsy research. The data warehouse system is built on top of a picture archiving and communication system (PACS) environment and applies an iterative object-oriented analysis and design (OOAD) approach and recognized data interface and design standards. The implementation is based on a Java CORBA (Common Object Request Broker Architecture) and Web-based architecture that separates the graphical user interface presentation, data warehouse business services, data staging area, and backend source systems into distinct software layers. To illustrate the practicality of the data warehouse system, the authors describe two distinct biomedical applications—namely, clinical diagnostic workup of multimodality neuroimaging cases and research data analysis and decision threshold on seizure foci lateralization. The image data warehouse framework can be modified and generalized for new application domains.
doi:10.1197/jamia.M0988
PMCID: PMC344584  PMID: 11971885
2.  An ICT infrastructure to integrate clinical and molecular data in oncology research 
BMC Bioinformatics  2012;13(Suppl 4):S5.
Background
The ONCO-i2b2 platform is a bioinformatics tool designed to integrate clinical and research data and support translational research in oncology. It is implemented by the University of Pavia and the IRCCS Fondazione Maugeri hospital (FSM), and grounded on the software developed by the Informatics for Integrating Biology and the Bedside (i2b2) research center. I2b2 has delivered an open source suite based on a data warehouse, which is efficiently interrogated to find sets of interesting patients through a query tool interface.
Methods
Onco-i2b2 integrates data coming from multiple sources and allows the users to jointly query them. I2b2 data are then stored in a data warehouse, where facts are hierarchically structured as ontologies. Onco-i2b2 gathers data from the FSM pathology unit (PU) database and from the hospital biobank and merges them with the clinical information from the hospital information system.
Our main effort was to provide a robust integrated research environment, giving a particular emphasis to the integration process and facing different challenges, consecutively listed: biospecimen samples privacy and anonymization; synchronization of the biobank database with the i2b2 data warehouse through a series of Extract, Transform, Load (ETL) operations; development and integration of a Natural Language Processing (NLP) module, to retrieve coded information, such as SNOMED terms and malignant tumors (TNM) classifications, and clinical tests results from unstructured medical records. Furthermore, we have developed an internal SNOMED ontology rested on the NCBO BioPortal web services.
Results
Onco-i2b2 manages data of more than 6,500 patients with breast cancer diagnosis collected between 2001 and 2011 (over 390 of them have at least one biological sample in the cancer biobank), more than 47,000 visits and 96,000 observations over 960 medical concepts.
Conclusions
Onco-i2b2 is a concrete example of how integrated Information and Communication Technology architecture can be implemented to support translational research. The next steps of our project will involve the extension of its capabilities by implementing new plug-in devoted to bioinformatics data analysis as well as a temporal query module.
doi:10.1186/1471-2105-13-S4-S5
PMCID: PMC3303735  PMID: 22536972
3.  Pseudonymization of patient identifiers for translational research 
Background
The usage of patient data for research poses risks concerning the patients’ privacy and informational self-determination. Next-generation-sequencing technologies and various other methods gain data from biospecimen, both for translational research and personalized medicine. If these biospecimen are anonymized, individual research results from genomic research, which should be offered to patients in a clinically relevant timeframe, cannot be associated back to the individual. This raises an ethical concern and challenges the legitimacy of anonymized patient samples. In this paper we present a new approach which supports both data privacy and the possibility to give feedback to patients about their individual research results.
Methods
We examined previously published privacy concepts regarding a streamlined de-pseudonymization process and a patient-based pseudonym as applicable to research with genomic data and warehousing approaches. All concepts identified in the literature review were compared to each other and analyzed for their applicability to translational research projects. We evaluated how these concepts cope with challenges implicated by personalized medicine. Therefore, both person-centricity issues and a separation of pseudonymization and de-pseudonymization stood out as a central theme in our examination. This motivated us to enhance an existing pseudonymization method regarding a separation of duties.
Results
The existing concepts rely on external trusted third parties, making de-pseudonymization a multistage process involving additional interpersonal communication, which might cause critical delays in patient care. Therefore we propose an enhanced method with an asymmetric encryption scheme separating the duties of pseudonymization and de-pseudonymization. The pseudonymization service provider is unable to conclude the patient identifier from the pseudonym, but assigns this ability to an authorized third party (ombudsman) instead. To solve person-centricity issues, a collision-resistant function is incorporated into the method. These two facts combined enable us to address essential challenges in translational research. A productive software prototype was implemented to prove the functionality of the suggested translational, data privacy-preserving method. Eventually, we performed a threat analysis to evaluate potential hazards connected with this pseudonymization method.
Conclusions
The proposed method offers sustainable organizational simplification regarding an ethically indicated, but secure and controlled process of de-pseudonymizing patients. A pseudonym is patient-centered to allow correlating separate datasets from one patient. Therefore, this method bridges the gap between bench and bedside in translational research while preserving patient privacy. Assigned ombudsmen are able to de-pseudonymize a patient, if an individual research result is clinically relevant.
doi:10.1186/1472-6947-13-75
PMCID: PMC3733629  PMID: 23883409
Pseudonymization; Pseudonymisation; Pseudonym; Anonyms and pseudonyms; Translational research; Biobanking; Data privacy; Individual research results; Record linkage; Re-identification; De-pseudonymization; De-pseudonymisation
4.  Computers in imaging and health care: Now and in the future 
Journal of Digital Imaging  2000;13(4):145-156.
Early picture archiving and communication systems (PACS) were characterized by the use of very expensive hardware devices, cumbersome display stations, duplication of database content, lack of interfaces to other clinical information systems, and immaturity in their understanding of the folder manager concepts and workflow reengineering. They were implemented historically at large academic medical centers by biomedical engineers and imaging informaticists. PACS were nonstandard, home-grown projects with mixed clinical acceptance. However, they clearly showed the great potential for PACS and filmless medical imaging. Filmless radiology is a reality today. The advent of efficient softcopy display of images provides a means for dealing with the ever-increasing number of studies and number of images per study. Computer power has increased, and archival storage cost has decreased to the extent that the economics of PACS is justifiable with respect to film. Network bandwidths have increased to allow large studies of many megabytes to arrive at display stations within seconds of examination completion. PACS vendors have recognized the need for efficient workflow and have built systems with intelligence in the mangement of patient data. Close integration with the hospital information system (HIS)-radiology information system (RIS) is critical for system functionality. Successful implementation of PACS requires integration or interoperation with hospital and radiology information systems. Besides the economic advantages, secure rapid access to all clinical information on patients, including imaging studies, anytime and anywhere, enhances the quality of patient care, although it is difficult to quantify. Medical image management systems are maturing, providing access outside of the radiology department to images and clinical information throughout the hospital or the enterprise via the Internet. Small and medium-sized community hospitals, private practices, and outpatient centers in rural areas will begin realizing the benefits of PACS already realized by the large tertiary care academic medical centers and research institutions. Hand-held devices and the Worldwide Web are going to change the way people communicate and do business. The impact on health care will be huge, including radiology. Computer-aided diagnosis, decision support tools, virtual imaging, and guidance systems will transform our practice as value-added applications utilizing the technologies pushed by PACS development efforts. Outcomes data and the electronic medical record (EMR) will drive our interactions with referring physicians and we expect the radiologist to become the informaticist, a new version of the medical management consultant.
doi:10.1007/BF03168389
PMCID: PMC3453069  PMID: 11110253
picture archiving and communication systems (PACS); image storage and retrieval; folder manager; workflow manager; radiology information systems; computers; digital radiology
5.  IT Infrastructure Components for Biobanking 
Applied Clinical Informatics  2010;1(4):419-429.
Objective
Within translational research projects in the recent years large biobanks have been established, mostly supported by homegrown, proprietary software solutions. No general requirements for biobanking IT infrastructures have been published yet. This paper presents an exemplary biobanking IT architecture, a requirements specification for a biorepository management tool and exemplary illustrations of three major types of requirements.
Methods
We have pursued a comprehensive literature review for biobanking IT solutions and established an interdisciplinary expert panel for creating the requirements specification. The exemplary illustrations were derived from a requirements analysis within two university hospitals.
Results
The requirements specification comprises a catalog with more than 130 detailed requirements grouped into 3 major categories and 20 subcategories. Special attention is given to multitenancy capabilities in order to support the project-specific definition of varying research and bio-banking contexts, the definition of workflows to track sample processing, sample transportation and sample storage and the automated integration of preanalytic handling and storage robots.
Conclusion
IT support for biobanking projects can be based on a federated architectural framework comprising primary data sources for clinical annotations, a pseudonymization service, a clinical data warehouse with a flexible and user-friendly query interface and a biorepository management system. Flexibility and scalability of all such components are vital since large medical facilities such as university hospitals will have to support biobanking for varying monocentric and multicentric research scenarios and multiple medical clients.
doi:10.4338/ACI-2010-05-RA-0034
PMCID: PMC3633318  PMID: 23616851
Requirement specification; biobanking; translational research information technology infrastructure
6.  Implementation of the CDC translational informatics platform - from genetic variants to the national Swedish Rheumatology Quality Register 
Background
Sequencing of the human genome and the subsequent analyses have produced immense volumes of data. The technological advances have opened new windows into genomics beyond the DNA sequence. In parallel, clinical practice generate large amounts of data. This represents an underused data source that has much greater potential in translational research than is currently realized. This research aims at implementing a translational medicine informatics platform to integrate clinical data (disease diagnosis, diseases activity and treatment) of Rheumatoid Arthritis (RA) patients from Karolinska University Hospital and their research database (biobanks, genotype variants and serology) at the Center for Molecular Medicine, Karolinska Institutet.
Methods
Requirements engineering methods were utilized to identify user requirements. Unified Modeling Language and data modeling methods were used to model the universe of discourse and data sources. Oracle11g were used as the database management system, and the clinical development center (CDC) was used as the application interface. Patient data were anonymized, and we employed authorization and security methods to protect the system.
Results
We developed a user requirement matrix, which provided a framework for evaluating three translation informatics systems. The implementation of the CDC successfully integrated biological research database (15172 DNA, serum and synovial samples, 1436 cell samples and 65 SNPs per patient) and clinical database (5652 clinical visit) for the cohort of 379 patients presents three profiles. Basic functionalities provided by the translational medicine platform are research data management, development of bioinformatics workflow and analysis, sub-cohort selection, and re-use of clinical data in research settings. Finally, the system allowed researchers to extract subsets of attributes from cohorts according to specific biological, clinical, or statistical features.
Conclusions
Research and clinical database integration is a real challenge and a road-block in translational research. Through this research we addressed the challenges and demonstrated the usefulness of CDC. We adhered to ethical regulations pertaining to patient data, and we determined that the existing software solutions cannot meet the translational research needs at hand. We used RA as a test case since we have ample data on active and longitudinal cohort.
doi:10.1186/1479-5876-11-85
PMCID: PMC3623742  PMID: 23548156
Swedish Rheumatology Quality Register (SRQ); Translational medicine platform; Secondary use of clinical data; Patient de-identification
7.  Asan Medical Information System for Healthcare Quality Improvement 
Healthcare Informatics Research  2010;16(3):191-197.
Objectives
This purpose of this paper is to introduce the status of the Asan Medical Center (AMC) medical information system with respect to healthcare quality improvement.
Methods
Asan Medical Information System (AMIS) is projected to become a completely electronic and digital information hospital. AMIS has played a role in improving the health care quality based on the following measures: safety, effectiveness, patient-centeredness, timeliness, efficiency, privacy, and security.
Results
AMIS consisted of several distinctive systems: order communication system, electronic medical record, picture archiving communication system, clinical research information system, data warehouse, enterprise resource planning, IT service management system, and disaster recovery system. The most distinctive features of AMIS were the high alert-medication recognition & management system, the integrated and severity stratified alert system, the integrated patient monitoring system, the perioperative diabetic care monitoring and support system, and the clinical indicator management system.
Conclusions
AMIS provides IT services for AMC, 7 affiliated hospitals and over 5,000 partners clinics, and was developed to improve healthcare services. The current challenge of AMIS is standard and interoperability. A global health IT strategy is needed to get through the current challenges and to provide new services as needed.
doi:10.4258/hir.2010.16.3.191
PMCID: PMC3089858  PMID: 21818439
Hospital Information Systems; Quality of Health Care; Clinical Decision Support Systems; Electronic Medical Record
8.  Clinical and research data integration: the i2b2-FSM experience  
In order to support and improve the efficiency of clinical research in specific health area, the University of Pavia and the IRCCS Fondazione Salvatore Maugeri of Pavia (FSM) are developing and implementing an i2b2 based platform, designed to collect data coming from hospital clinical practice and scientific research. The work made in FSM is committed to support an affordable, less intrusive and more personalized care, increasing the quality of clinical practice as well as improving the scientific results. Such a aim depends on the application of information and communication technologies and the use of data. An integrated data warehouse has been implemented to support clinicians and researchers in two medical fields with a great impact on the population: oncology and cardiology. Furthermore the data warehouse approach has been tested with administrative information, allowing a financial view of clinical data.
PMCID: PMC3845786  PMID: 24303274
9.  Pseudonymization of Radiology Data for Research Purposes 
Journal of Digital Imaging  2006;20(3):284-295.
Medical image processing methods and algorithms, developed by researchers, need to be validated and tested. Test data would ideally be real clinical data especially that clinical data is varied and exists in large volumes. Nowadays, clinical data is accessible electronically and has important value for researchers. However, the usage of clinical data for research purposes should respect data confidentiality, patient right to privacy, and patient consent. In fact, clinical data is nominative given that it contains information about the patient such as name, age, and identification number. Evidently, clinical data needs to be de-identified to be exported to research databases. However, the same patient is usually followed during a long period of time. The disease progression and the diagnostic evolution represent extremely valuable information for researchers as well. Our objective is to build a research database from de-identified clinical data while enabling the data set to be easily incremented by exporting new pseudonymous data, acquired over a long period of time. Pseudonymization is data de-identification, such that data belonging to an individual in the clinical environment still belong to the same individual in the de-identified research version. In this paper, we explore various software architectures to enable the implementation of an imaging research database that can be incremented in time. We also evaluate their security and discuss their security pitfalls. As most imaging data accessible electronically is available with the digital imaging and communication in medicine (DICOM) standard, we propose a de-identification scheme that closely follows DICOM recommendations. Our work can be used to enable electronic health record (EHR) secondary usage such as public surveillance and research, while maintaining patient confidentiality.
doi:10.1007/s10278-006-1051-4
PMCID: PMC3043895  PMID: 17191099
Research database; confidentiality; security; privacy; de-identification; pseudonymization; nominative health care data; radiology; medical imaging
10.  A review of radio frequency identification technology for the anatomic pathology or biorepository laboratory: Much promise, some progress, and more work needed 
Patient safety initiatives throughout the anatomic laboratory and in biorepository laboratories have mandated increasing emphasis on the need for accurately identifying and tracking biospecimen assets throughout their production lifecycle and for archiving/retrieval purposes. However, increasing production volume along with complex workflow characteristics, reliance on manual production processes, and required asset movement to disparate destinations throughout asset lifecycles continue to challenge laboratory efforts. Radio Frequency Identification (RFID) technology, use of radio waves to communicate data between electronic tags attached to objects and a reader, shows significant potential to facilitate and overcome these hurdles. Advantages over traditional barcode labeling include readability without direct line-of-sight alignment to the reader, ability to read multiple tags simultaneously, higher data storage capacity, faster data transmission rate, and capacity to perform multiple read-writes of data to the tag. Most importantly, use of radio waves decreases the need to manually scan each asset, and at each step, identification or tracking event is needed. Temperature monitoring by on-board sensors and three-dimensional position tracking are additional potential benefits of using RFID technology. To date, barriers to implementation of RFID systems in the anatomic laboratory include increased associated costs of tags and readers, system software, data security concerns, lack of specific data standards for stored information, and potential for technological obsolescence during decades of specimen storage. Novel RFID production techniques and increased production capacity are projected to lower costs of some tags to a few cents each. Potentially, information security concerns can be addressed by techniques such as shielding, data encryption, and tag pseudonyms. Commitment by stakeholder groups to develop RFID tag data standards for anatomic pathology and biorepository laboratories could avoid or mitigate the “islands of data” dilemma presented by barcode usage where there are innumerable standards and a consequent paucity of hardware or software “plug and play” interoperability. Work remains to be done to establish the durability and appropriate shielding of individual tag types for use in harsh laboratory environmental conditions, and for long-term archival storage. Finally, given the requirements for long-term storage of biospecimen assets, consideration should be given to ways of mitigating data isolation due to eventual technological obsolescence of a particular RFID technology or software.
doi:10.4103/2153-3539.83738
PMCID: PMC3162748  PMID: 21886890
Challenges; implementation; radio frequency identification tags; standards
11.  A cryptologic based trust center for medical images. 
OBJECTIVE: To investigate practical solutions that can integrate cryptographic techniques and picture archiving and communication systems (PACS) to improve the security of medical images. DESIGN: The PACS at the University of California San Francisco Medical Center consolidate images and associated data from various scanners into a centralized data archive and transmit them to remote display stations for review and consultation purposes. The purpose of this study is to investigate the model of a digital trust center that integrates cryptographic algorithms and protocols seamlessly into such a digital radiology environment to improve the security of medical images. MEASUREMENTS: The timing performance of encryption, decryption, and transmission of the cryptographic protocols over 81 volumetric PACS datasets has been measured. Lossless data compression is also applied before the encryption. The transmission performance is measured against three types of networks of different bandwidths: narrow-band Integrated Services Digital Network, Ethernet, and OC-3c Asynchronous Transfer Mode. RESULTS: The proposed digital trust center provides a cryptosystem solution to protect the confidentiality and to determine the authenticity of digital images in hospitals. The results of this study indicate that diagnostic images such as x-rays and magnetic resonance images could be routinely encrypted in PACS. However, applying encryption in teleradiology and PACS is a tradeoff between communications performance and security measures. CONCLUSION: Many people are uncertain about how to integrate cryptographic algorithms coherently into existing operations of the clinical enterprise. This paper describes a centralized cryptosystem architecture to ensure image data authenticity in a digital radiology department. The system performance has been evaluated in a hospital-integrated PACS environment.
PMCID: PMC116325  PMID: 8930857
12.  Lessons Learned from Development of De-identification System for Biomedical Research in a Korean Tertiary Hospital 
Healthcare Informatics Research  2013;19(2):102-109.
Objectives
The Korean government has enacted two laws, namely, the Personal Information Protection Act and the Bioethics and Safety Act to prevent the unauthorized use of medical information. To protect patients' privacy by complying with governmental regulations and improve the convenience of research, Asan Medical Center has been developing a de-identification system for biomedical research.
Methods
We reviewed Korean regulations to define the scope of the de-identification methods and well-known previous biomedical research platforms to extract the functionalities of the systems. Based on these review results, we implemented necessary programs based on the Asan Medical Center Information System framework which was built using the Microsoft. NET Framework and C#.
Results
The developed de-identification system comprises three main components: a de-identification tool, a search tool, and a chart review tool. The de-identification tool can substitute a randomly assigned research ID for a hospital patient ID, remove the identifiers in the structured format, and mask them in the unstructured format, i.e., texts. This tool achieved 98.14% precision and 97.39% recall for 6,520 clinical notes. The search tool can find the number of patients which satisfies given search criteria. The chart review tool can provide de-identified patient's clinical data for review purposes.
Conclusions
We found that a clinical data warehouse was essential for successful implementation of the de-identification system, and this system should be tightly linked to an electronic Institutional Review Board system for easy operation of honest brokers. Additionally, we found that a secure cloud environment could be adopted to protect patients' privacy more thoroughly.
doi:10.4258/hir.2013.19.2.102
PMCID: PMC3717433  PMID: 23882415
Access to Information; Information Systems; Research Design; Research Ethics; Biomedical Research
13.  OPTIMAS-DW: A comprehensive transcriptomics, metabolomics, ionomics, proteomics and phenomics data resource for maize 
BMC Plant Biology  2012;12:245.
Background
Maize is a major crop plant, grown for human and animal nutrition, as well as a renewable resource for bioenergy. When looking at the problems of limited fossil fuels, the growth of the world’s population or the world’s climate change, it is important to find ways to increase the yield and biomass of maize and to study how it reacts to specific abiotic and biotic stress situations. Within the OPTIMAS systems biology project maize plants were grown under a large set of controlled stress conditions, phenotypically characterised and plant material was harvested to analyse the effect of specific environmental conditions or developmental stages. Transcriptomic, metabolomic, ionomic and proteomic parameters were measured from the same plant material allowing the comparison of results across different omics domains. A data warehouse was developed to store experimental data as well as analysis results of the performed experiments.
Description
The OPTIMAS Data Warehouse (OPTIMAS-DW) is a comprehensive data collection for maize and integrates data from different data domains such as transcriptomics, metabolomics, ionomics, proteomics and phenomics. Within the OPTIMAS project, a 44K oligo chip was designed and annotated to describe the functions of the selected unigenes. Several treatment- and plant growth stage experiments were performed and measured data were filled into data templates and imported into the data warehouse by a Java based import tool. A web interface allows users to browse through all stored experiment data in OPTIMAS-DW including all data domains. Furthermore, the user can filter the data to extract information of particular interest. All data can be exported into different file formats for further data analysis and visualisation. The data analysis integrates data from different data domains and enables the user to find answers to different systems biology questions. Finally, maize specific pathway information is provided.
Conclusions
With OPTIMAS-DW a data warehouse for maize was established, which is able to handle different data domains, comprises several analysis results that will support researchers within their work and supports systems biological research in particular. The system is available at http://www.optimas-bioenergy.org/optimas_dw.
doi:10.1186/1471-2229-12-245
PMCID: PMC3577462  PMID: 23272737
Maize; Zea mays; Database; WGCNA; Biomass; Yield; Data integration; Transcriptomics; Metabolomics; Phenomics
14.  Toward a Fully De-identified Biomedical Information Warehouse 
The Information Warehouse at the Ohio State University Medical Center is a comprehensive repository of business, clinical, and research data from various source systems. Data collected here is a valuable resource that facilitates both translational research and personalized healthcare. The use of such data in research is governed by federal privacy regulations with oversight by the Institutional Review Board. In 2006, the Information Warehouse was recognized by the OSU IRB as an “Honest Broker” of clinical data, providing investigators with de-identified or limited datasets under stipulations contained in a signed data use agreement. In order to streamline this process even further, the Information Warehouse is developing a de-identified data warehouse that is suitable for direct user access through a controlled query tool that is aimed to support both research and education activities. In this paper we report our findings on performance evaluation of different de-identification schemes that may be used to ensure regulatory compliance while also facilitating practical database updating and querying. We also discuss how date-shifting in the de-identification process can impact other data elements such as diagnosis and procedure codes and consider a possible solution to those problems.
PMCID: PMC2815386  PMID: 20351882
15.  The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview 
PLoS Medicine  2011;8(1):e1000387.
Aziz Sheikh and colleagues report the findings of their systematic overview that assessed the impact of eHealth solutions on the quality and safety of health care.
Background
There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care.
Methods and Findings
We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking.
Conclusions
There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given. In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle. Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
There is considerable international interest in exploiting the potential of digital health care solutions, often referred to as eHealth—the use of information and communication technologies—to enhance the quality and safety of health care. Often accompanied by large costs, any large-scale expenditure on eHealth—such as electronic health records, picture archiving and communication systems, ePrescribing, associated computerized provider order entry systems, and computerized decision support systems—has tended to be justified on the grounds that these are efficient and cost-effective means for improving health care. In 2005, the World Health Assembly passed an eHealth resolution (WHA 58.28) that acknowledged, “eHealth is the cost-effective and secure use of information and communications technologies in support of health and health-related fields, including health-care services, health surveillance, health literature, and health education, knowledge and research,” and urged member states to develop and implement eHealth technologies. Since then, implementing eHealth technologies has become a main priority for many countries. For example, England has invested at least £12.8 billion in a National Programme for Information Technology for the National Health Service, and the Obama administration in the United States has committed to a US$38 billion eHealth investment in health care.
Why Was This Study Done?
Despite the wide endorsement of and support for eHealth, the scientific basis of its benefits—which are repeatedly made and often uncritically accepted—remains to be firmly established. A robust evidence-based perspective on the advantages on eHealth could help to suggest priority areas that have the greatest potential for benefit to patients and also to inform international eHealth deliberations on costs. Therefore, in order to better inform the international community, the authors systematically reviewed the published systematic review literature on eHealth technologies and evaluated the impact of these technologies on the quality and safety of health care delivery.
What Did the Researchers Do and Find?
The researchers divided eHealth technologies into three main categories: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. Then, implementing methods based on those developed by the Cochrane Collaboration and the NHS Service Delivery and Organisation Programme, the researchers used detailed search strategies and maps of health care quality, safety, and eHealth interventions to identify relevant systematic reviews (and related theoretical, methodological, and technical material) published between 1997 and 2010. Using these techniques, the researchers retrieved a total of 46,349 references from which they identified 108 reviews. The 53 reviews that the researchers finally selected (and critically reviewed) provided the main evidence base for assessing the impact of eHealth technologies in the three categories selected.
In their systematic review of systematic reviews, the researchers included electronic health records and picture archiving communications systems in their evaluation of category 1, computerized provider (or physician) order entry and e-prescribing in category 2, and all clinical information systems that, when used in the context of eHealth technologies, integrate clinical and demographic patient information to support clinician decision making in category 3.
The researchers found that many of the clinical claims made about the most commonly used eHealth technologies were not substantiated by empirical evidence. The evidence base in support of eHealth technologies was weak and inconsistent and importantly, there was insubstantial evidence to support the cost-effectiveness of these technologies. For example, the researchers only found limited evidence that some of the many presumed benefits could be realized; importantly, they also found some evidence that introducing these new technologies may on occasions also generate new risks such as prescribers becoming over-reliant on clinical decision support for e-prescribing, or overestimate its functionality, resulting in decreased practitioner performance.
What Do These Findings Mean?
The researchers found that despite the wide support for eHealth technologies and the frequently made claims by policy makers when constructing business cases to raise funds for large-scale eHealth projects, there is as yet relatively little empirical evidence to substantiate many of the claims made about eHealth technologies. In addition, even for the eHealth technology tools that have proven to be successful, there is little evidence to show that such tools would continue to be successful beyond the contexts in which they were originally developed. Therefore, in light of the lack of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, the authors say that future eHealth technologies should be evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle, and include socio-technical factors to maximize the likelihood of successful implementation and adoption in a given context. Furthermore, it is equally important that eHealth projects that have already been commissioned are subject to rigorous, multidisciplinary, and independent evaluation.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000387.
The authors' broader study is: Car J, Black A, Anandan C, Cresswell K, Pagliari C, McKinstry B, et al. (2008) The Impact of eHealth on the Quality and Safety of Healthcare. Available at: http://www.haps.bham.ac.uk/publichealth/cfhep/001.shtml
More information is available on the World Health Assembly eHealth resolution
The World Health Organization provides information at the Global Observatory on eHealth, as well as a global insight into eHealth developments
The European Commission provides Information on eHealth in Europe and some examples of good eHealth practice
More information is provided on NHS Connecting for Health
doi:10.1371/journal.pmed.1000387
PMCID: PMC3022523  PMID: 21267058
16.  Development of a Clinical Data Warehouse for Hospital Infection Control 
Existing data stored in a hospital's transactional servers have enormous potential to improve performance measurement and health care quality. Accessing, organizing, and using these data to support research and quality improvement projects are evolving challenges for hospital systems. The authors report development of a clinical data warehouse that they created by importing data from the information systems of three affiliated public hospitals. They describe their methodology; difficulties encountered; responses from administrators, computer specialists, and clinicians; and the steps taken to capture and store patient-level data. The authors provide examples of their use of the clinical data warehouse to monitor antimicrobial resistance, to measure antimicrobial use, to detect hospital-acquired bloodstream infections, to measure the cost of infections, and to detect antimicrobial prescribing errors. In addition, they estimate the amount of time and money saved and the increased precision achieved through the practical application of the data warehouse.
doi:10.1197/jamia.M1299
PMCID: PMC212782  PMID: 12807807
17.  Image standards in Tissue-Based Diagnosis (Diagnostic Surgical Pathology) 
Diagnostic Pathology  2008;3:17.
Background
Progress in automated image analysis, virtual microscopy, hospital information systems, and interdisciplinary data exchange require image standards to be applied in tissue-based diagnosis.
Aims
To describe the theoretical background, practical experiences and comparable solutions in other medical fields to promote image standards applicable for diagnostic pathology.
Theory and experiences
Images used in tissue-based diagnosis present with pathology – specific characteristics. It seems appropriate to discuss their characteristics and potential standardization in relation to the levels of hierarchy in which they appear. All levels can be divided into legal, medical, and technological properties. Standards applied to the first level include regulations or aims to be fulfilled. In legal properties, they have to regulate features of privacy, image documentation, transmission, and presentation; in medical properties, features of disease – image combination, human – diagnostics, automated information extraction, archive retrieval and access; and in technological properties features of image acquisition, display, formats, transfer speed, safety, and system dynamics. The next lower second level has to implement the prescriptions of the upper one, i.e. describe how they are implemented. Legal aspects should demand secure encryption for privacy of all patient related data, image archives that include all images used for diagnostics for a period of 10 years at minimum, accurate annotations of dates and viewing, and precise hardware and software information. Medical aspects should demand standardized patients' files such as DICOM 3 or HL 7 including history and previous examinations, information of image display hardware and software, of image resolution and fields of view, of relation between sizes of biological objects and image sizes, and of access to archives and retrieval. Technological aspects should deal with image acquisition systems (resolution, colour temperature, focus, brightness, and quality evaluation procedures), display resolution data, implemented image formats, storage, cycle frequency, backup procedures, operation system, and external system accessibility. The lowest third level describes the permitted limits and threshold in detail. At present, an applicable standard including all mentioned features does not exist to our knowledge; some aspects can be taken from radiological standards (PACS, DICOM 3); others require specific solutions or are not covered yet.
Conclusion
The progress in virtual microscopy and application of artificial intelligence (AI) in tissue-based diagnosis demands fast preparation and implementation of an internationally acceptable standard. The described hierarchic order as well as analytic investigation in all potentially necessary aspects and details offers an appropriate tool to specifically determine standardized requirements.
doi:10.1186/1746-1596-3-17
PMCID: PMC2362107  PMID: 18423031
18.  Common object request broker architecture (CORBA)-based security services for the Virtual Radiology Environment 
Journal of Digital Imaging  2000;13(Suppl 1):59-70.
The US Army Great Plains Regional Medical Command (GPRMC) has a requirement to conform to Department of Defense (DoD) and Army security policies for the Virtual Radiology Environment (VRE) Project. Within the DoD, security policy is defined as the set of laws, rules, and practices that regulate how an organization manages, protects, and distributes sensitive information. Security policy in the DoD is described by the Trusted Computer System Evaluation Criteria (TCSEC), Army Regulation (AR) 380-19, Defense Information Infrastructure Common Operating Environment (DII COE), Military Health Services System Automated Information Systems Security Policy Manual, and National Computer Security Center-TG-005, “Trusted Network Interpretation.” These documents were used to develop a security policy that defines information protection requirements that are made with respect to those laws, rules, and practices that are required to protect the information stored and processed in the VREProject. The goal of the security policy is to provide, for a C2-level of information protection while also satisfying the functional needs of the GPRMC’s user community. This report summarizes the security policy for the VRE and defines the CORBA security services that satisfy the policy. In the VRE, the information to be protected is embedded into three major information components: (1) Patient information consists of Digital Imaging and Communications in Medicine (DICOM)-formatted fields. The patients information resides in the digital imaging network picture archiving and communication system (DIN-PACS) networks in the database archive systems and includes (a) patient demographics; (b) patient images from x-ray, computed tomography (CT), magnetic resonance imaging (MRI), and ultrasound (US); and (c) prior patient images and related patient history. (2) Meta-Manager information to be protected consists of several data objects. This information is distributed to the Meta-Manager nodes and includes (a) radiologist schedules; (b) modality worklists; (c) routed case information; (d) DIN-PACS and Composite Health Care system (CHCS), messages, and Meta-Manager administrative and security information; and (e) patient case information. (3) Access control and communications security is required in the VRE to control who uses the VRE and Meta-Manager facilities and to secure the messages between VRE components. The CORBA Security Service Specification version 1.5 is designed to allow up to TCSEC’s B2-level security for distributed objects. The CORBA Security Service Specification defines the functionality of several security features: identification and authentication, authorization and access control, security auditing, communication security, nonrepudiation, and security administration. This report describes the enhanced security features for the VRE and their implementation using commercial CORBA Security Service software products.
doi:10.1007/BF03167627
PMCID: PMC3453280  PMID: 10847365
19.  A HIPAA-Compliant Architecture for Securing Clinical Images 
Journal of Digital Imaging  2005;19(2):172-180.
The Health Insurance Portability and Accountability Act (HIPAA, instituted April 2003) Security Standards mandate health institutions to protect health information against unauthorized use or disclosure. One approach to addressing this mandate is by utilizing user access control and generating audit trails of the various authorized as well as unauthorized user access of health data. Although most current clinical image systems [e.g., picture archiving and communication system (PACS)] have components that generate log files for application debugging purposes, there is a lack of methodology to obtain and synthesize the pertinent data from the large volumes of log data generated by these multiple components within a PACS. We have designed a HIPAA-compliant architecture specifically for tracking and auditing the image workflow of clinical imaging systems such as PACS. As an initial first step, we developed HIPAA-compliant auditing system (H-CAS) based on parts of this HIPAA-compliant architecture. H-CAS was implemented within a test-bed PACS simulator located in the Image Processing and Informatics lab at the University of Southern California. Evaluation scenarios were developed where different user types performed legal and illegal access of PACS image data within each of the different components in the PACS simulator. Results were based on whether the scenarios of unauthorized access were correctly identified and documented as well as on normal operational activity. Integration and implementation pitfalls were also noted and included.
doi:10.1007/s10278-005-9248-5
PMCID: PMC3045193  PMID: 16341963
HIPAA; security; auditing; monitoring
20.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
Objective
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
Technology
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT Trial
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
Conclusions
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
21.  A pragmatic method for electronic medical record-based observational studies: developing an electronic medical records retrieval system for clinical research 
BMJ Open  2012;2(6):e001622.
Objective
The use of electronic medical record (EMR) data is necessary to improve clinical research efficiency. However, it is not easy to identify patients who meet research eligibility criteria and collect the necessary information from EMRs because the data collection process must integrate various techniques, including the development of a data warehouse and translation of eligibility criteria into computable criteria. This research aimed to demonstrate an electronic medical records retrieval system (ERS) and an example of a hospital-based cohort study that identified both patients and exposure with an ERS. We also evaluated the feasibility and usefulness of the method.
Design
The system was developed and evaluated.
Participants
In total, 800 000 cases of clinical information stored in EMRs at our hospital were used.
Primary and secondary outcome measures
The feasibility and usefulness of the ERS, the method to convert text from eligible criteria to computable criteria, and a confirmation method to increase research data accuracy.
Results
To comprehensively and efficiently collect information from patients participating in clinical research, we developed an ERS. To create the ERS database, we designed a multidimensional data model optimised for patient identification. We also devised practical methods to translate narrative eligibility criteria into computable parameters. We applied the system to an actual hospital-based cohort study performed at our hospital and converted the test results into computable criteria. Based on this information, we identified eligible patients and extracted data necessary for confirmation by our investigators and for statistical analyses with our ERS.
Conclusions
We propose a pragmatic methodology to identify patients from EMRs who meet clinical research eligibility criteria. Our ERS allowed for the efficient collection of information on the eligibility of a given patient, reduced the labour required from the investigators and improved the reliability of the results.
doi:10.1136/bmjopen-2012-001622
PMCID: PMC3533000  PMID: 23117567
Oral & Maxillofacial Surgery; Public Health; Statistics & Research Methods
22.  Assessing and Comparing Information Security in Swiss Hospitals 
Background
Availability of information in hospitals is an important prerequisite for good service. Significant resources have been invested to improve the availability of information, but it is also vital that the security of this information can be guaranteed.
Objective
The goal of this study was to assess information security in hospitals through a questionnaire based on the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) standard ISO/IEC 27002, evaluating Information technology – Security techniques – Code of practice for information-security management, with a special focus on the effect of the hospitals’ size and type.
Methods
The survey, set up as a cross-sectional study, was conducted in January 2011. The chief information officers (CIOs) of 112 hospitals in German-speaking Switzerland were invited to participate. The online questionnaire was designed to be fast and easy to complete to maximize participation. To group the analyzed controls of the ISO/IEC standard 27002 in a meaningful way, a factor analysis was performed. A linear score from 0 (not implemented) to 3 (fully implemented) was introduced. The scores of the hospitals were then analyzed for significant differences in any of the factors with respect to size and type of hospital. The participating hospitals were offered a benchmark report about their status.
Results
The 51 participating hospitals had an average score of 51.1% (range 30.6% - 81.9%) out of a possible 100% where all items in the questionnaire were fully implemented. Room for improvement could be identified, especially for the factors covering “process and quality management” (average score 1.3 ± 0.8 out of a maximum of 3) and “organization and risk management” (average score 1.3 ± 0.7 out of a maximum of 3). Private hospitals scored significantly higher than university hospitals in the implementation of “security zones” and “backup” (P = .008).
Conclusions
Half (50.00%, 8588/17,177) of all assessed hospital beds in German-speaking Switzerland are in hospitals that have a score of 49% or less of the maximum possible score in information security. Patient data need to be better protected because of the data protection laws and because sensitive, personal data should be guaranteed confidentiality, integrity, and availability.
doi:10.2196/ijmr.2137
PMCID: PMC3626122  PMID: 23611956
information security; information protection; computer security standards; electronic health records organization & administration; hospital information systems; Switzerland.
23.  Security Protection of DICOM Medical Images Using Dual-Layer Reversible Watermarking with Tamper Detection Capability 
Journal of Digital Imaging  2010;24(3):528-540.
Teleradiology applications and universal availability of patient records using web-based technology are rapidly gaining importance. Consequently, digital medical image security has become an important issue when images and their pertinent patient information are transmitted across public networks, such as the Internet. Health mandates such as the Health Insurance Portability and Accountability Act require healthcare providers to adhere to security measures in order to protect sensitive patient information. This paper presents a fully reversible, dual-layer watermarking scheme with tamper detection capability for medical images. The scheme utilizes concepts of public-key cryptography and reversible data-hiding technique. The scheme was tested using medical images in DICOM format. The results show that the scheme is able to ensure image authenticity and integrity, and to locate tampered regions in the images.
doi:10.1007/s10278-010-9295-4
PMCID: PMC3092037  PMID: 20414697
Digital watermark; security; image authentication; teleradiology; public-key cryptography
24.  An Improved Tamper Detection and Localization Scheme for Volumetric DICOM Images 
Journal of Digital Imaging  2012;25(6):751-763.
The development of teleradiology brings the convenience of global medical record access along with the concerns over the security of medical images transmitted over the open network. With the prevailing adoption of three-dimensional (3-D) imaging modalities, it is vital to develop a security mechanism to provide large volumes of medical images with privacy and reliability. This paper presents the development of a new and improved method of implementing tamper detection and localization based on a fully reversible digital watermarking scheme for the protection of volumetric DICOM images. This tamper detection and localization method utilizes the 3-D property of volumetric data to achieve much faster processing time at both sender and receiver sides without compromising tamper localization accuracy. The performance of the proposed scheme was evaluated by using sample volumetric DICOM images. Results show that the scheme achieved on average about 65 % and 72 % reduction in watermarking and dewatermarking processing time, respectively. For cases where the images had been tampered, it is possible to detect and localize the tampered areas with improved localization resolution in the images using the scheme.
doi:10.1007/s10278-012-9518-y
PMCID: PMC3491158  PMID: 22832896
Image authentication; Medical data security; Tamper detection; Watermarking
25.  Information systems integration in radiology 
Journal of Digital Imaging  1999;12(Suppl 1):218-222.
Advances in information systems and technology in conjunction with outside forces requiring improved reporting are driving sweeping changes in the practice of radiology. In most academic radiology departments, there can be at least five separate information systems in daily use, a clinical picture archiving and communication system (PACS), a hospital information system (HIS), a radiology information system (RIS), a voice-recognition dictation system, and an electronic teaching/research file system. A PACS will have incomplete, incorrect, and inconsistent data if manual data entry is used. Correct routing of studies for diagnostic reporting and clinical review requires accurate information about the study type and the referring physician or service, often not easily entered manually. An HIS is a hospital-wide information system used to access patient information, reports from various services, and billing information. The RIS is typically a system specifically designed to place radiology orders, to receive interpretations, and to prepare bills for patients. Voice-recognition systems automatically transcribe the radiologist’s dictation, eliminating transcription delays. Another system that is needed in a teaching hospital holds images and data for research and education. Integration of diverse systems must be performed to provide the functionality required by an electronic radiology department and the services it supports. Health Level 7 (HL7) and Digital Imaging and Communications in Medicine (DICOM) have enabled sharing of data among systems and can be used as the building blocks for truly integrated systems, but the user community and manufacturers need to specify the types of functionality needed to build clinically useful systems. Although technology development has produced the tools for interoperability for clinical and research/educational use, more work needs to be done to define the types of interaction that needs to be performed to realize the potential of these systems.
doi:10.1007/BF03168810
PMCID: PMC3452903  PMID: 10342221

Results 1-25 (1178174)