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1.  What Is eHealth (4): A Scoping Exercise to Map the Field 
Background
Lack of consensus on the meaning of eHealth has led to uncertainty among academics, policymakers, providers and consumers. This project was commissioned in light of the rising profile of eHealth on the international policy agenda and the emerging UK National Programme for Information Technology (now called Connecting for Health) and related developments in the UK National Health Service.
Objectives
To map the emergence and scope of eHealth as a topic and to identify its place within the wider health informatics field, as part of a larger review of research and expert analysis pertaining to current evidence, best practice and future trends.
Methods
Multiple databases of scientific abstracts were explored in a nonsystematic fashion to assess the presence of eHealth or conceptually related terms within their taxonomies, to identify journals in which articles explicitly referring to eHealth are contained and the topics covered, and to identify published definitions of the concept. The databases were Medline (PubMed), the Cumulative Index of Nursing and Allied Health Literature (CINAHL), the Science Citation Index (SCI), the Social Science Citation Index (SSCI), the Cochrane Database (including Dare, Central, NHS Economic Evaluation Database [NHS EED], Health Technology Assessment [HTA] database, NHS EED bibliographic) and ISTP (now known as ISI proceedings).We used the search query, “Ehealth OR e-health OR e*health”. The timeframe searched was 1997-2003, although some analyses contain data emerging subsequent to this period. This was supplemented by iterative searches of Web-based sources, such as commercial and policy reports, research commissioning programmes and electronic news pages. Definitions extracted from both searches were thematically analyzed and compared in order to assess conceptual heterogeneity.
Results
The term eHealth only came into use in the year 2000, but has since become widely prevalent. The scope of the topic was not immediately discernable from that of the wider health informatics field, for which over 320000 publications are listed in Medline alone, and it is not explicitly represented within the existing Medical Subject Headings (MeSH) taxonomy. Applying eHealth as narrative search term to multiple databases yielded 387 relevant articles, distributed across 154 different journals, most commonly related to information technology and telemedicine, but extending to such areas as law. Most eHealth articles are represented on Medline. Definitions of eHealth vary with respect to the functions, stakeholders, contexts and theoretical issues targeted. Most encompass a broad range of medical informatics applications either specified (eg, decision support, consumer health information) or presented in more general terms (eg, to manage, arrange or deliver health care). However the majority emphasize the communicative functions of eHealth and specify the use of networked digital technologies, primarily the Internet, thus differentiating eHealth from the field of medical informatics. While some definitions explicitly target health professionals or patients, most encompass applications for all stakeholder groups. The nature of the scientific and broader literature pertaining to eHealth closely reflects these conceptualizations.
Conclusions
We surmise that the field – as it stands today – may be characterized by the global definitions suggested by Eysenbach and Eng.
doi:10.2196/jmir.7.1.e9
PMCID: PMC1550637  PMID: 15829481
eHealth; Internet; telemedicine; medical informatics
2.  A Health Department’s Collaborative Model for Disease Surveillance Capacity Building 
Objective
Highlight one academic health department’s unique approach to optimizing collaborative opportunities for capacity development and document the implications for chronic disease surveillance and population health.
Introduction
Public Health departments are increasingly called upon to be innovative in quality service delivery under a dwindling resource climate as highlighted in several publications of the Institute of Medicine. Collaboration with other entities in the delivery of core public health services has emerged as a recurring theme. One model of this collaboration is an academic health department: a formal affiliation between a health professions school and a local health department. Initially targeted at workforce development, this model of collaboration has since yielded dividends in other core public health service areas including community assessment, program evaluation, community-based participatory research and data analysis.
The Duval County Health Department (DCHD), Florida, presents a unique community-centered model of the academic health department. Prominence in local informatics infrastructure capacity building and hosting a CDC-CSTE applied public health informatics fellowship (APHIF) in the Institute for Public Health Informatics and Research (IPHIR) in partnership with the Center for Health Equity Research, University of Florida & Shands medical center are direct dividends of this collaborative model.
Methods
We examined the collaborative efforts of the DCHD and present the unique advantages these have brought in the areas of entrenched data-driven public health service culture, community assessments, program evaluation, community-based participatory research and health informatics projects.
Results
Advantages of the model include a data-driven culture with the balanced scorecard model in leadership and sub-departmental emphases on quality assurance in public health services. Activities in IPHIR include data-driven approaches to program planning and grant developments, program evaluations, data analyses and impact assessments for the DCHD and other community health stakeholders.
Reports developed by IPHIR have impacted policy formulation by highlighting the need for sub county level data differentiation to address health disparities. Unique community-based mapping of Duval County into health zones based on health risk factors correlating with health outcome measures have been published. Other reports highlight chronic disease surveillance data and health scorecards in special populations.
Partnerships with regional higher institutions (University of Florida, University of North Florida and Florida A&M University) increased public health service delivery and yielded rich community-based participatory research opportunities.
Cutting edge participation in health IT policy implementation led to the hosting of the fledgling community HIE, the Jacksonville Health Information Network, as well as leadership in shaping the landscape of the state HIE. This has immense implications for public health surveillance activities as chronic disease surveillance and public health service research take center stage under new healthcare payment models amidst increasing calls for quality assurance in public health services.
DCHD is currently hosting a CDC-funded fellowship in applied public health informatics. Some of the projects materializing from the fellowship are the mapping of the current public health informatics profile of the DCHD, a community based diabetes disease registry to aid population-based management and surveillance of diabetes, development of a proposal for a combined primary care/general preventive medicine residency in UF-Shands Medical Center, Jacksonville and mobilization of DCHD healthcare providers for the roll-out of the state-built electronic medical records system (Florida HMS-EHR).
Conclusions
Academic health centers provide a model of collaboration that directly impacts on their success in delivering core public health services. Disease surveillance is positively affected by the diverse community affiliations of an academic health department. The academic health department, as epitomized by DCHD, is also better positioned to seize up-coming opportunities for local public health capacity building.
PMCID: PMC3692891
Academic Health Departments; collaborative model; health informatics projects
3.  Update from CDC’s Public Health Surveillance & Informatics Program Office (PHSIPO) 
Objective
To provide updates on current activities and future directions for the National Notifiable Diseases Surveillance System (NNDSS), BioSense 2.0, and the Behavioral Risk Factor Surveillance System (BRFSS) and on the role of PHSIPO as the “home” at CDC for addressing cross-cutting issues in surveillance and informatics practice.
Introduction
The practice of public health surveillance is evolving as electronic health records (EHRs) and automated laboratory information systems are increasing adopted, as new approaches for health information exchange are employed, and as new health information standards affect the entire cascade of surveillance information flow. These trends have been accelerated by the Federal program to promote the Meaningful Use of electronic health records, which includes explicit population health objectives. The growing use of Internet “cloud” technology provides new opportunities for improving information sharing and for reducing surveillance costs. Potential benefits include not only faster and more complete surveillance but also new opportunities for providing population health information back to clinicians.
For public health surveys, new Internet-based sampling and survey methods hold the promise of complementing existing telephone-based surveys, which have been plagued by declining response rates despite the addition of cell-phone sampling. While new technologies hold promise for improving surveillance practice, there are multiple challenges, including constraints on public health budgets and the workforce. This panel will explore how PHSIPO is addressing these opportunities and challenges.
Methods
Panelists will provide updates on 1) PHSIPO’s role in engaging health departments, the organizations that represent them, and CDC programs in shaping national policies for implementing the Meaningful Use program, 2) how the BioSense 2.0 program is supporting growth in syndromic surveillance capacity, including its partnership with ISDS in developing standards for syndromic surveillance as part of Meaningful Use, 3) improvements that are underway in strengthening the NNDSS, including efforts to improve CDC’s support for health department disease reporting systems and to develop a “shared services” approach that could provide a platform for streamlining the exchange of information between health departments and CDC, 4) pilot development of Internet-based panels of survey volunteers to supplement existing telephone-based sampling in the BRFSS and of approaches to extend BRFSS survey information through consent-based linkage of survey responses to selected measures recorded in respondents’ EHRs.
Results
Potential questions or discussion points that might arise include: What can or should be done to assure that the population health objectives of Meaningful Use are fulfilled? What are the lessons learned to date in leveraging investments in the Meaningful Use of EHRs to improve disease reporting and syndromic surveillance systems? What are the next steps in developing BioSense 2.0 to assure that it leads to strengthened surveillance capacity at both state/local and regional/national levels? How can insights from the BioSense redesign be applied to improve case reporting and other surveillance capacities? What is CDC doing to address states’ concerns about the growing number of CDC surveillance systems? How will national discussions about the future of public health affect the future surveillance practice? What can be done to assure the ongoing representativeness of population health surveys? Is it feasible to link BRFSS responses to information obtained from EHRs? How can data from surveillance become part of the real-time evidence base for clinical decision making?
Conclusions
The intended outcome of the panel is to foster a conversation between the panelists and the audience, to inform the audience about recent developments in PHSIPO, to obtain insights from the audience about innovations and ideas arising from their experience, and to generate new ideas for approaches to meeting the needs of public health for surveillance information.
PMCID: PMC3692948
Surveillance; BioSense 2.0; Notifiable Diseases; BRFSS—Behavioral Risk Factor Surveillance System
4.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
5.  Gaps in the Existing Public Health Informatics Training Programs: A Challenge to the Development of a Skilled Global Workforce 
The objective of this study was to explore public health informatics (PHI) training programs that currently exist to meet the growing demand for a trained global workforce. We used several search engines, scientific databases, and the websites of informatics organizations; sources included PubMed, Google, the American Medical Informatics Organization, and the International Medical Informatics Organization. The search was conducted from May to July 2011 and from January to February 2012 using key words such as informatics, public health informatics, or biomedical informatics along with academic programs, training, certificate, graduate programs, or postgraduate programs. Course titles and catalog descriptions were gathered from the program or institution websites. Variables included PHI program categories, location and mode of delivery, program credits, and costs. Each course was then categorized based on its title and description as available on the Internet. Finally, we matched course titles and descriptions with the competencies for PHIs determined by Centers for Disease Control and Prevention (CDC). Descriptive analysis was performed to report means and frequency distributions for continuous and categorical variables. Stratified analysis was performed to explore average credits and cost per credit among both the public and private institutions. Fifteen PHI programs were identified across 13 different institutions, the majority of which were US-based. The average number of credits and the associated costs required to obtain PHI training were much higher in private as compared to public institutions. The study results suggest that a need for online contextual and cost-effective PHI training programs exists to address the growing needs of professionals worldwide who are using technology to improve public health in their respective countries.
PMCID: PMC3510646  PMID: 23209452
public health informatics; training; global workforce
6.  Public Health 101 for Informaticians 
Public health is a complex discipline that has contributed substantially to improving the health of the population. Public health action involves a variety of interventions and methods, many of which are now taken for granted by the general public. The specific focus and nature of public health interventions continue to evolve, but the fundamental principles of public health remain stable. These principles include a focus on the health of the population rather than of individuals; an emphasis on disease prevention rather than treatment; a goal of intervention at all vulnerable points in the causal pathway of disease, injury, or disability; and operation in a governmental rather than a private context. Public health practice occurs at local, state, and federal levels and involves various professional disciplines. Public health principles and practice are illustrated by a case study example of neural tube defects and folic acid. The application of information science and technology in public health practice provides previously unfathomed opportunities to improve the health of the population. Clinical informaticians and others in the health care system are crucial partners in addressing the challenges and opportunities offered by public health informatics.
PMCID: PMC130068  PMID: 11687565
7.  Metropolis redux: the unique importance of library skills in informatics 
Objectives: The objective is to highlight the important role that librarians have in teaching within a successful medical informatics program. Librarians regularly utilize skills that, although not technology dependent, are essential to conducting computer-based research. The Metropolis analogy is used to introduce the part librarians play as informatics partners. Science fiction is a modern mythology that, beyond a technical exterior, has lasting value in its ability to reflect the human condition. The teaching of medical informatics, an intersection of technology and knowledge, is also most relevant when it transcends the operation of databases and systems. Librarians can teach students to understand, research, and utilize information beyond specific technologies.
Methods: A survey of twenty-six informatics programs was conducted during 2002, with specific emphasis on the role of the library service.
Results: The survey demonstrated that librarians currently do have a central role in informatics instruction, and that library-focused skills form a significant part of the curriculum in many of those programs. In addition, librarians have creative opportunities to enhance their involvement in informatics training. As a sample program in the study, the development of the informatics course at the Massachusetts College of Pharmacy and Health Sciences is included.
Conclusions: Medical informatics training is a wonderful opportunity for librarians to collaborate with professionals from the sciences and other information disciplines. Librarians' unique combination of human research and technology skills provides a valuable contribution to any program.
PMCID: PMC385302  PMID: 15098050
8.  Processing of Novel Electronic Health Data to Support Public Health Surveillance 
Objective
To describe data management and analytic processes undertaken to rapidly acquire and use previously unavailable data during a public health emergency response.
Introduction
Accurately gauging the health status of a population during an event of public health significance (e.g. hurricanes, H1N1 2009 pandemic) in support of emergency response and situation awareness efforts can be a challenge for established public health surveillance systems in terms of geographic and population coverage as well as the appropriateness of health indicators. The demand for timely, accurate, and event-specific data can require the rapid development of new data assets to “fill-in” existing information gaps to better characterize the scope, scale, magnitude, and population health impact of a given event within a very narrow time-window. Such new data assets may be concurrently under development and evaluation while being used to support response efforts. Recent examples include the “drop-in” surveillance processes deployed at evacuation centers following Hurricane Katrina1 and the illness and injury surveillance systems established for response workers during the Deepwater Horizon Oil spill response. During the 2009 H1N1 pandemic response, CDC acquired access to data from several national-level health information systems that previously had been un-vetted as public health information sources. These sources provided data extracts from massive administrative or electronic medical records (EMR) based in hospital and primary care settings. It was hoped that such data could supplement existing influenza surveillance systems and aid in the characterization of the pandemic. Few of these new data sources had formal documentation or concise information on the underlying populations and geographies represented.
Methods
Throughout CDC’s H1N1 response; epidemiologists, data managers, and IT specialists collaborated to develop standardized methods to rapidly characterize, process, store, and provision these new data for analysis and reporting by subject matter experts.These new data were not part of a formally designed sample so each data source needed to undergo extensive empirical review to understand, representativeness, unique nuances, and facilitate the interpretation of analytic results and accurate reporting to public health decision makers.
Results
Such work requires a multi-disciplinary approach that cyclically reviews incoming data iteratively while concurrently documenting findings, modifying initial business rules (e.g. extraction, binning, or coding logic), and analytic techniques to produce the most interpretable and informative results. To elucidate the underlying complexity for these sequential and contingent activities occurring across information technology, informatics, and epidemiology domains, we retrospectively described the intersection of the discrete tangible tasks and workforce roles via a TaskFlow diagram (Figure 1). Vertical “swim lanes” represent discrete tasks: On-boarding/Documentation, Analysis/Visualization, and Visualization/Reporting. Workforce roles such as Data management, Epidemiological Analysis, and Communications are broken into three horizontal “swim lanes” as each requires dramatically different skillsets and are accomplished by different individuals. Each of the steps (1–9) in the diagram were leveraged to produce supplemental artifacts (e.g. code books, extraction guides, defined analytic methods, etc.) to support ongoing analysis, interpretation, reporting, and over process improvement. The totality of all of these interrelated activities have an a priori purpose of characterizing population health during an event of public health significance to support disease prevention and control efforts in a timely fashion.
Conclusions
This presentation describes the underlying business processes, activities, and roles used in transforming novel data sources, during the H1N1 response, into informative assets to support public health surveillance. By formally articulating and describing each of these steps, in a structured manner, we hope to contribute to the dialogue of developing useful practices for leveraging electronic health data to meet public health surveillance challenges.
PMCID: PMC3692875
informatics; surveillance; emergency response; h1n1; data management
9.  Online Public Health Preparedness Training Programs: An Evaluation of User Experience with the Technological Environment 
Online Journal of Public Health Informatics  2010;2(3):ojphi.v2i3.3012.
Objectives:
Several public health education programs and government agencies across the country have started offering virtual or online training programs in emergency preparedness for people who are likely to be involved in managing or responding to different types of emergency situations such as natural disasters, epidemics, bioterrorism, etc. While such online training programs are more convenient and cost-effective than traditional classroom-based programs, their success depends to a great extent on the underlying technological environment. Specifically, in an online technological environment, different types of user experiences come in to play—users’ utilitarian or pragmatic experience, their fun or hedonic experience, their social experience, and most importantly, their usability experience—and these different user experiences critically shape the program outcomes, including course completion rates. This study adopts a multi-disciplinary approach and draws on theories in human computer interaction, distance learning theories, usability research, and online consumer behavior to evaluate users’ experience with the technological environment of an online emergency preparedness training program and discusses its implications for the design of effective online training programs. .
Methods:
Data was collected using a questionnaire from 377 subjects who had registered for and participated in online public health preparedness training courses offered by a large public university in the Northeast.
Results:
Analysis of the data indicates that as predicted, participants had higher levels of pragmatic and usability experiences compared to their hedonic and sociability experiences. Results also indicate that people who experienced higher levels of pragmatic, hedonic, sociability and usability experiences were more likely to complete the course(s) they registered for compared to those who reported lower levels.
Discussion:
The study findings hold important implications for the design of effective online emergency preparedness training targeted at diverse audiences including the general public, health care and public health professionals, and emergency responders. Strategies for improving participants’ pragmatic, hedonic, sociability and usability experiences are outlined.
Conclusion:
There are ample opportunities to improve the pragmatic, hedonic, sociability and usability experiences of the target audience. This is critical to improve the participants’ learning and retention as well as the completion rates for the courses offered. Online emergency preparedness programs are likely to play a crucial role in preparing emergency responders at all levels in the future and their success has critical implications for public health informatics.
doi:10.5210/ojphi.v2i3.3012
PMCID: PMC3615772  PMID: 23569595
10.  Building the Foundations of an Informatics Agenda for Global Health - 2011 Workshop Report 
Online Journal of Public Health Informatics  2012;4(1):ojphi.v4i1.4027.
Strengthening the capacity of public health systems to protect and promote the health of the global population continues to be essential in an increasingly connected world. Informatics practices and principles can play an important role for improving global health response capacity. A critical step is to develop an informatics agenda for global health so that efforts can be prioritized and important global health issues addressed. With the aim of building a foundation for this agenda, the authors developed a workshop to examine the evidence in this domain, recognize the gaps, and document evidence-based recommendations. On 21 August 2011, at the 2011 Public Health Informatics Conference in Atlanta, GA, USA, a four-hour interactive workshop was conducted with 85 participants from 15 countries representing governmental organizations, private sector companies, academia, and non-governmental organizations.
The workshop discussion followed an agenda of a plenary session - planning and agenda setting - and four tracks: Policy and governance; knowledge management, collaborative networks and global partnerships; capacity building; and globally reusable resources: metrics, tools, processes, templates, and digital assets. Track discussions examined the evidence base and the participants’ experience to gather information about the current status, compelling and potential benefits, challenges, barriers, and gaps for global health informatics as well as document opportunities and recommendations.
This report provides a summary of the discussions and key recommendations as a first step towards building an informatics agenda for global health. Attention to the identified topics and issues is expected to lead to measurable improvements in health equity, health outcomes, and impacts on population health. We propose the workshop report be used as a foundation for the development of the full agenda and a detailed roadmap for global health informatics activities based on further contribution from key stakeholders. The global health informatics agenda and roadmap can provide guidance to countries for developing and enhancing their individual and regional agendas.
doi:10.5210/ojphi.v4i1.4027
PMCID: PMC3615805  PMID: 23569628
Global Public Health Informatics; Agenda; Policy; Capacity Development; Collaboration
11.  An Epidemiological Network Model for Disease Outbreak Detection 
PLoS Medicine  2007;4(6):e210.
Background
Advanced disease-surveillance systems have been deployed worldwide to provide early detection of infectious disease outbreaks and bioterrorist attacks. New methods that improve the overall detection capabilities of these systems can have a broad practical impact. Furthermore, most current generation surveillance systems are vulnerable to dramatic and unpredictable shifts in the health-care data that they monitor. These shifts can occur during major public events, such as the Olympics, as a result of population surges and public closures. Shifts can also occur during epidemics and pandemics as a result of quarantines, the worried-well flooding emergency departments or, conversely, the public staying away from hospitals for fear of nosocomial infection. Most surveillance systems are not robust to such shifts in health-care utilization, either because they do not adjust baselines and alert-thresholds to new utilization levels, or because the utilization shifts themselves may trigger an alarm. As a result, public-health crises and major public events threaten to undermine health-surveillance systems at the very times they are needed most.
Methods and Findings
To address this challenge, we introduce a class of epidemiological network models that monitor the relationships among different health-care data streams instead of monitoring the data streams themselves. By extracting the extra information present in the relationships between the data streams, these models have the potential to improve the detection capabilities of a system. Furthermore, the models' relational nature has the potential to increase a system's robustness to unpredictable baseline shifts. We implemented these models and evaluated their effectiveness using historical emergency department data from five hospitals in a single metropolitan area, recorded over a period of 4.5 y by the Automated Epidemiological Geotemporal Integrated Surveillance real-time public health–surveillance system, developed by the Children's Hospital Informatics Program at the Harvard-MIT Division of Health Sciences and Technology on behalf of the Massachusetts Department of Public Health. We performed experiments with semi-synthetic outbreaks of different magnitudes and simulated baseline shifts of different types and magnitudes. The results show that the network models provide better detection of localized outbreaks, and greater robustness to unpredictable shifts than a reference time-series modeling approach.
Conclusions
The integrated network models of epidemiological data streams and their interrelationships have the potential to improve current surveillance efforts, providing better localized outbreak detection under normal circumstances, as well as more robust performance in the face of shifts in health-care utilization during epidemics and major public events.
Most surveillance systems are not robust to shifts in health care utilization. Ben Reis and colleagues developed network models that detected localized outbreaks better and were more robust to unpredictable shifts.
Editors' Summary
Background.
The main task of public-health officials is to promote health in communities around the world. To do this, they need to monitor human health continually, so that any outbreaks (epidemics) of infectious diseases (particularly global epidemics or pandemics) or any bioterrorist attacks can be detected and dealt with quickly. In recent years, advanced disease-surveillance systems have been introduced that analyze data on hospital visits, purchases of drugs, and the use of laboratory tests to look for tell-tale signs of disease outbreaks. These surveillance systems work by comparing current data on the use of health-care resources with historical data or by identifying sudden increases in the use of these resources. So, for example, more doctors asking for tests for salmonella than in the past might presage an outbreak of food poisoning, and a sudden rise in people buying over-the-counter flu remedies might indicate the start of an influenza pandemic.
Why Was This Study Done?
Existing disease-surveillance systems don't always detect disease outbreaks, particularly in situations where there are shifts in the baseline patterns of health-care use. For example, during an epidemic, people might stay away from hospitals because of the fear of becoming infected, whereas after a suspected bioterrorist attack with an infectious agent, hospitals might be flooded with “worried well” (healthy people who think they have been exposed to the agent). Baseline shifts like these might prevent the detection of increased illness caused by the epidemic or the bioterrorist attack. Localized population surges associated with major public events (for example, the Olympics) are also likely to reduce the ability of existing surveillance systems to detect infectious disease outbreaks. In this study, the researchers developed a new class of surveillance systems called “epidemiological network models.” These systems aim to improve the detection of disease outbreaks by monitoring fluctuations in the relationships between information detailing the use of various health-care resources over time (data streams).
What Did the Researchers Do and Find?
The researchers used data collected over a 3-y period from five Boston hospitals on visits for respiratory (breathing) problems and for gastrointestinal (stomach and gut) problems, and on total visits (15 data streams in total), to construct a network model that included all the possible pair-wise comparisons between the data streams. They tested this model by comparing its ability to detect simulated disease outbreaks implanted into data collected over an additional year with that of a reference model based on individual data streams. The network approach, they report, was better at detecting localized outbreaks of respiratory and gastrointestinal disease than the reference approach. To investigate how well the network model dealt with baseline shifts in the use of health-care resources, the researchers then added in a large population surge. The detection performance of the reference model decreased in this test, but the performance of the complete network model and of models that included relationships between only some of the data streams remained stable. Finally, the researchers tested what would happen in a situation where there were large numbers of “worried well.” Again, the network models detected disease outbreaks consistently better than the reference model.
What Do These Findings Mean?
These findings suggest that epidemiological network systems that monitor the relationships between health-care resource-utilization data streams might detect disease outbreaks better than current systems under normal conditions and might be less affected by unpredictable shifts in the baseline data. However, because the tests of the new class of surveillance system reported here used simulated infectious disease outbreaks and baseline shifts, the network models may behave differently in real-life situations or if built using data from other hospitals. Nevertheless, these findings strongly suggest that public-health officials, provided they have sufficient computer power at their disposal, might improve their ability to detect disease outbreaks by using epidemiological network systems alongside their current disease-surveillance systems.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040210.
Wikipedia pages on public health (note that Wikipedia is a free online encyclopedia that anyone can edit, and is available in several languages)
A brief description from the World Health Organization of public-health surveillance (in English, French, Spanish, Russian, Arabic, and Chinese)
A detailed report from the US Centers for Disease Control and Prevention called “Framework for Evaluating Public Health Surveillance Systems for the Early Detection of Outbreaks”
The International Society for Disease Surveillance Web site
doi:10.1371/journal.pmed.0040210
PMCID: PMC1896205  PMID: 17593895
12.  Implementation of a Mobile-Based Surveillance System in Saudi Arabia for the 2009 Hajj 
Objective
To develop and implement a mobile-based disease surveillance system in the Kingdom of Saudi Arabia (KSA) for the 2009 Hajj; to strengthen public health preparedness for the H1N1 Influenza A pandemic.
Introduction
The Hajj is considered to be the largest mass gathering to date, attracting an estimated 2.5 million Muslims from more than 160 countries annually (1). The H1N1 Influenza A pandemic of 2009 generated a global wave of concern among public health departments that resulted in the institution of preventive measures to limit transmission of the disease. Meanwhile, the pandemic amplified an urgent need for more innovative disease surveillance tools to combat disease outbreaks.
A collaborative effort between the KSA Ministry of Health (MOH) and the U.S. Centers for Disease Control and Prevention (CDC) was initiated to implement and deploy an informatics-based mobile solution to provide early detection and reporting of disease outbreaks during the 2009 Hajj. The mobile-based tool aimed to improve the efficiency of disease case reporting, recognize potential outbreaks, and enhance the MOH’s operational effectiveness in deploying resources (2).
Methods
We designed a case-based system consisting of a mobile-based data collection toolkit and interactive map-based user interface to perform geospatial analysis and visualization. A train-the-trainer approach was adapted to provide training to the KSA MOH.
Results
More than 200 public health and information and communication technology (ICT) professionals were trained, and 100 mobile devices were deployed during the 2009 Hajj. Nine diseases and conditions that were considered as highest priority during the Hajj were under surveillance, including H1N1 Influenza A and Influenza-like Illness.
Pilot testing of the system was conducted during the first week of Ramadan and a modified system was fully operational during the Hajj. Data collected on smartphones were sent to the system via a secured network. The data were processed immediately and visualized on highly interactive maps with local and global views.
Conclusions
Effective public health decision-making requires timely and accurate information from a variety of sources. Mobile-based systems (e.g., personal digital assistants and smartphones) for data collection, transmission, reporting, and analyses provide a faster, easier, and cheaper means to communicate standardized and shareable public health data for decision-making (3). Mobile-based systems have been recognized as a quick and effective response solution to mass gatherings and recommended as data gathering and communication systems with geographical information system (GIS) capability (2). This paper explored the development and implementation of the Global Positioning System/ Geographic Information System (GPS/GIS) enabled mobile-based disease surveillance system as a feasible and effective way to support and strengthen preparedness for H1N1 Influenza A during the 2009 Hajj.
Mobile computing technology can be utilized to provide rapid and accurate data collection for public health decision-making during mass gatherings. The GIS-based interactive mapping tool provided a pioneering example of the power of a geographically based internet-accessible surveillance system with real-time data visualization. The technical challenges in the process of implementation and in the field were also identified.
A need now exists for a comprehensive and comparative review of parameters such as handheld device cost, training required, and system evaluations because selecting the appropriate software/hardware and system remains a challenge not only to public health professionals, but to the development and application of informatics technology as well.
PMCID: PMC3692784
Mobile Technology; GIS/GPS; Mass Gatherings; Surveillance System; Public Health Preparedness
13.  Harnessing genomics to improve health in the Eastern Mediterranean Region – an executive course in genomics policy 
Background
While innovations in medicine, science and technology have resulted in improved health and quality of life for many people, the benefits of modern medicine continue to elude millions of people in many parts of the world. To assess the potential of genomics to address health needs in EMR, the World Health Organization's Eastern Mediterranean Regional Office and the University of Toronto Joint Centre for Bioethics jointly organized a Genomics and Public Health Policy Executive Course, held September 20th–23rd, 2003, in Muscat, Oman. The 4-day course was sponsored by WHO-EMRO with additional support from the Canadian Program in Genomics and Global Health. The overall objective of the course was to collectively explore how to best harness genomics to improve health in the region. This article presents the course findings and recommendations for genomics policy in EMR.
Methods
The course brought together senior representatives from academia, biotechnology companies, regulatory bodies, media, voluntary, and legal organizations to engage in discussion. Topics covered included scientific advances in genomics, followed by innovations in business models, public sector perspectives, ethics, legal issues and national innovation systems.
Results
A set of recommendations, summarized below, was formulated for the Regional Office, the Member States and for individuals.
• Advocacy for genomics and biotechnology for political leadership;
• Networking between member states to share information, expertise, training, and regional cooperation in biotechnology; coordination of national surveys for assessment of health biotechnology innovation systems, science capacity, government policies, legislation and regulations, intellectual property policies, private sector activity;
• Creation in each member country of an effective National Body on genomics, biotechnology and health to:
- formulate national biotechnology strategies
- raise biotechnology awareness
- encourage teaching and training of biotechnology
- devise integration of biotechnology within national health systems.
Conclusion
The recommendations provide the basis for a road map for EMR to take steps to harness biotechnology for better and more equitable health. As a result of these recommendations, health ministers from the region, at the 50th Regional Committee Meeting held in October 2003, have urged Member States to establish national bodies of biotechnology to formulate a strategic vision for developing biotechnology in the service of the region's health. These efforts promise to raise the profile of genomics in EMR and increase regional cooperation in this exciting new field.
doi:10.1186/1478-4505-3-1
PMCID: PMC548293  PMID: 15663786
14.  The history of pathology informatics: A global perspective 
Pathology informatics has evolved to varying levels around the world. The history of pathology informatics in different countries is a tale with many dimensions. At first glance, it is the familiar story of individuals solving problems that arise in their clinical practice to enhance efficiency, better manage (e.g., digitize) laboratory information, as well as exploit emerging information technologies. Under the surface, however, lie powerful resource, regulatory, and societal forces that helped shape our discipline into what it is today. In this monograph, for the first time in the history of our discipline, we collectively perform a global review of the field of pathology informatics. In doing so, we illustrate how general far-reaching trends such as the advent of computers, the Internet and digital imaging have affected pathology informatics in the world at large. Major drivers in the field included the need for pathologists to comply with national standards for health information technology and telepathology applications to meet the scarcity of pathology services and trained people in certain countries. Following trials by a multitude of investigators, not all of them successful, it is apparent that innovation alone did not assure the success of many informatics tools and solutions. Common, ongoing barriers to the widespread adoption of informatics devices include poor information technology infrastructure in undeveloped areas, the cost of technology, and regulatory issues. This review offers a deeper understanding of how pathology informatics historically developed and provides insights into what the promising future might hold.
doi:10.4103/2153-3539.112689
PMCID: PMC3714902  PMID: 23869286
History; pathology informatics; clinical informatics; electronic medical record; laboratory information systems; pathology education
15.  A Strategic Plan for the Second Phase (2013–2015) of the Korea Biobank Project 
The Korea Biobank Project (KBP) was led by the Ministry of Health and Welfare to establish a network between the National Biobank of Korea and biobanks run by university-affiliated general hospitals (regional biobanks). The Ministry of Health and Welfare started the project to enhance medical and health technology by collecting, managing, and providing researchers with high-quality human bioresources. The National Biobank of Korea, under the leadership of the Ministry of Health and Welfare, collects specimens through various cohorts and regional biobanks within university hospitals gather specimens from patients. The project began in 2008, and the first phase ended in 2012, which meant that there needed to be a plan for the second phase that begins in 2013. Consequently, professionals from within and outside the project were gathered to develop a plan for the second phase. Under the leadership of the planning committee, six working groups were formed to formulate a practical plan. By conducting two workshops with experts in the six working groups and the planning committee and three forums in 2011 and 2012, they have developed a strategic plan for the second phase of the KBP. This document presents a brief report of the second phase of the project based on a discussion with them.
During the first phase of the project (2008–2012), a network was set up between the National Biobank of Korea and 17 biobanks at university-affiliated hospitals in an effort to unify informatics and governance among the participating biobanks. The biobanks within the network manage data on their biospecimens with a unified Biobank Information Management System. Continuous efforts are being made to develop a common standard operating procedure for resource collection, management, distribution, and personal information security, and currently, management of these data is carried out in a somewhat unified manner. In addition, the KBP has trained and educated professionals to work within the biobanks, and has also carried out various publicity promotions to the public and researchers. During the first phase, biospecimens from more than 300,000 participants through various cohorts and biospecimens from more than 200,000 patients from hospitals were collected, which were distributed to approximately 600 research projects.
The planning committee for the second phase evaluated that the first phase of the KBP was successful. However, the first phase of the project was meant to allow autonomy to the individual biobanks. The biobanks were able to choose the kind of specimens they were going to collect and the amount of specimen they would set as a goal, as well as being allowed to choose their own methods to manage their biobanks (autonomy). Therefore, some biobanks collected resources that were easy to collect and the resources needed by researchers were not strategically collected. In addition, there was also a low distribution rate to researchers outside of hospitals, who do not have as much access to specimens and cases as those in hospitals. There were also many cases in which researchers were not aware of the KBP, and the distribution processes were not set up to be convenient to the demands of researchers.
Accordingly, the second phase of the KBP will be focused on increasing the integration and cooperation between the biobanks within the network. The KBP plans to set goals for the strategic collection of the needed human bioresources. Although the main principle of the first phase was to establish infrastructure and resource collection, the key objective of the second phase is the efficient utilization of gathered resources. In order to fully utilize the gathered resources in an efficient way, distribution systems and policies must be improved. Vitalization of distribution, securing of high-value resource and related clinical and laboratory information, international standardization of resource management systems, and establishment of a virtuous cycle between research and development (R&D) and biobanks are the four main strategies. Based on these strategies, 12 related objectives have been set and are planned to be executed.
doi:10.1016/j.phrp.2013.03.006
PMCID: PMC3767092  PMID: 24159540
biobank; biobank network; biospecimen; Korea Biobank Project; National Biobank of Korea
16.  Pathology informatics fellowship training: Focus on molecular pathology 
Background:
Pathology informatics is both emerging as a distinct subspecialty and simultaneously becoming deeply integrated within the breadth of pathology practice. As specialists, pathology informaticians need a broad skill set, including aptitude with information fundamentals, information systems, workflow and process, and governance and management. Currently, many of those seeking training in pathology informatics additionally choose training in a second subspecialty. Combining pathology informatics training with molecular pathology is a natural extension, as molecular pathology is a subspecialty with high potential for application of modern biomedical informatics techniques.
Methods and Results:
Pathology informatics and molecular pathology fellows and faculty evaluated the current fellowship program's core curriculum topics and subtopics for relevance to molecular pathology. By focusing on the overlap between the two disciplines, a structured curriculum consisting of didactics, operational rotations, and research projects was developed for those fellows interested in both pathology informatics and molecular pathology.
Conclusions:
The scope of molecular diagnostics is expanding dramatically as technology advances and our understanding of disease extends to the genetic level. Here, we highlight many of the informatics challenges facing molecular pathology today, and outline specific informatics principles necessary for the training of future molecular pathologists.
doi:10.4103/2153-3539.129444
PMCID: PMC4023031  PMID: 24843823
Clinical informatics; informatics fellowship training; molecular pathology informatics; molecular pathology training; molecular pathology; pathology informatics fellowship; pathology informatics training; pathology informatics
17.  Peer-to-Peer JXTA Architecture for Continuing Mobile Medical Education Incorporated in Rural Public Health Centers 
Objectives:
Mobile technology helps to improve continuing medical education; this includes all aspects of public health care as well as keeping one’s knowledge up-to-date. The program of continuing medical and health education is intertwined with mobile health technology, which forms an imperative component of national strategies in health. Continuing mobile medical education (CMME) programs are designed to ensure that all medical and health-care professionals stay up-to-date with the knowledge required through mobile JXTA to appraise modernized strategies so as to achieve national goals of health-care information distribution.
Methods:
In this study, a 20-item questionnaire was distributed to 280 health professionals practicing traditional training learning methodologies (180 nurses, 60 doctors, and 40 health inspectors) in 25 rural hospitals. Among the 83% respondents, 56% are eager to take new learning methodologies as part of their evaluation, which is considered for promotion to higher grades, increments, or as part of their work-related activities.
Results:
The proposed model was executed in five public health centers in which nurses and health inspectors registered in the JXTA network were referred to the record peer group by administrators. A mobile training program on immunization was conducted through the ADVT, with the lectures delivered on their mobiles. Credits are given after taking the course and completing an evaluation test. The system is faster compared with traditional learning.
Conclusion:
Medical knowledge management and mobile-streaming application support the CMME system through JXTA. The mobile system includes online lectures and practice quizzes, as well as assignments and interactions with health professionals. Evaluation and assessments are done online and credits certificates are provided based on the score the student obtains. The acceptance of mobile JXTA peer-to-peer learning has created a drastic change in learning methods among rural health professionals. The professionals undergo training and should pass an exam in order to obtain the credits. The system is controlled and monitored by the administrator peer group, which makes it more flexible and structured. Compared with traditional learning system, enhanced study improves cloud-based mobile medical education technology.
doi:10.1016/j.phrp.2013.03.004
PMCID: PMC3767093  PMID: 24159539
continuing mobile medical education; JXTA; M-learn; peer-to-peer
18.  Eurocan plus report: feasibility study for coordination of national cancer research activities 
Summary
The EUROCAN+PLUS Project, called for by the European Parliament, was launched in October 2005 as a feasibility study for coordination of national cancer research activities in Europe. Over the course of the next two years, the Project process organized over 60 large meetings and countless smaller meetings that gathered in total over a thousand people, the largest Europe–wide consultation ever conducted in the field of cancer research.
Despite a strong tradition in biomedical science in Europe, fragmentation and lack of sustainability remain formidable challenges for implementing innovative cancer research and cancer care improvement. There is an enormous duplication of research effort in the Member States, which wastes time, wastes money and severely limits the total intellectual concentration on the wide cancer problem. There is a striking lack of communication between some of the biggest actors on the European scene, and there are palpable tensions between funders and those researchers seeking funds.
It is essential to include the patients’ voice in the establishment of priority areas in cancer research at the present time. The necessity to have dialogue between funders and scientists to establish the best mechanisms to meet the needs of the entire community is evident. A top priority should be the development of translational research (in its widest form), leading to the development of effective and innovative cancer treatments and preventive strategies. Translational research ranges from bench–to–bedside innovative cancer therapies and extends to include bringing about changes in population behaviours when a risk factor is established.
The EUROCAN+PLUS Project recommends the creation of a small, permanent and independent European Cancer Initiative (ECI). This should be a model structure and was widely supported at both General Assemblies of the project. The ECI should assume responsibility for stimulating innovative cancer research and facilitating processes, becoming the common voice of the cancer research community and serving as an interface between the cancer research community and European citizens, patients’ organizations, European institutions, Member States, industry and small and medium enterprises (SMEs), putting into practice solutions aimed at alleviating barriers to collaboration and coordination of cancer research activities in the European Union, and dealing with legal and regulatory issues. The development of an effective ECI will require time, but this entity should be established immediately. As an initial step, coordination efforts should be directed towards the creation of a platform on translational research that could encompass (1) coordination between basic, clinical and epidemiological research; (2) formal agreements of co–operation between comprehensive cancer centres and basic research laboratories throughout Europe and (3) networking between funding bodies at the European level.
The European Parliament and its instruments have had a major influence in cancer control in Europe, notably in tobacco control and in the implementation of effective population–based screening. To make further progress there is a need for novelty and innovation in cancer research and prevention in Europe, and having a platform such as the ECI, where those involved in all aspects of cancer research can meet, discuss and interact, is a decisive development for Europe.
Executive Summary
Cancer is one of the biggest public health crises facing Europe in the 21st century—one for which Europe is currently not prepared nor preparing itself. Cancer is a major cause of death in Europe with two million casualties and three million new cases diagnosed annually, and the situation is set to worsen as the population ages.
These facts led the European Parliament, through the Research Directorate-General of the European Commission, to call for initiatives for better coordination of cancer research efforts in the European Union. The EUROCAN+PLUS Project was launched in October 2005 as a feasibility study for coordination of national cancer research activities. Over the course of the next two years, the Project process organized over 60 large meetings and countless smaller meetings that gathered in total over a thousand people. In this respect, the Project became the largest Europe-wide consultation ever conducted in the field of cancer research, implicating researchers, cancer centres and hospitals, administrators, healthcare professionals, funding agencies, industry, patients’ organizations and patients.
The Project first identified barriers impeding research and collaboration in research in Europe. Despite a strong tradition in biomedical science in Europe, fragmentation and lack of sustainability remain the formidable challenges for implementing innovative cancer research and cancer care improvement. There is an enormous duplication of research effort in the Member States, which wastes time, wastes money and severely limits the total intellectual concentration on the wide cancer problem. There is a striking lack of communication between some of the biggest actors on the European scene, and there are palpable tensions between funders and those researchers seeking funds.
In addition, there is a shortage of leadership, a multiplicity of institutions each focusing on its own agenda, sub–optimal contact with industry, inadequate training, non–existent career paths, low personnel mobility in research especially among clinicians and inefficient funding—all conspiring against efficient collaboration in cancer care and research. European cancer research today does not have a functional translational research continuum, that is the process that exploits biomedical research innovations and converts them into prevention methods, diagnostic tools and therapies. Moreover, epidemiological research is not integrated with other types of cancer research, and the implementation of the European Directives on Clinical Trials 1 and on Personal Data Protection 2 has further slowed the innovation process in Europe. Furthermore, large inequalities in health and research exist between the EU–15 and the New Member States.
The picture is not entirely bleak, however, as the European cancer research scene presents several strengths, such as excellent basic research and clinical research and innovative etiological research that should be better exploited.
When considering recommendations, several priority dimensions had to be retained. It is essential that proposals include actions and recommendations that can benefit all Member States of the European Union and not just States with the elite centres. It is also essential to have a broader patient orientation to help provide the knowledge to establish cancer control possibilities when we exhaust what can be achieved by the implementation of current knowledge. It is vital that the actions proposed can contribute to the Lisbon Strategy to make Europe more innovative and competitive in (cancer) research.
The Project participants identified six areas for which consensus solutions should be implemented in order to obtain better coordination of cancer research activities. The required solutions are as follows. The proactive management of innovation, detection, facilitation of collaborations and maintenance of healthy competition within the European cancer research community.The establishment of an exchange portal of information for health professionals, patients and policy makers.The provision of guidance for translational and clinical research including the establishment of a translational research platform involving comprehensive cancer centres and cancer research centres.The coordination of calls and financial management of cancer research projects.The construction of a ‘one–stop shop’ as a contact interface between the industry, small and medium enterprises, scientists and other stakeholders.The support of greater involvement of healthcare professionals in translational research and multidisciplinary training.
In the course of the EUROCAN+PLUS consultative process, several key collaborative projects emerged between the various groups and institutes engaged in the consultation. There was a collaboration network established with Europe’s leading Comprehensive Cancer Centres; funding was awarded for a closer collaboration of Owners of Cancer Registries in Europe (EUROCOURSE); there was funding received from FP7 for an extensive network of leading Biological Resource Centres in Europe (BBMRI); a Working Group identified the special needs of Central, Eastern and South–eastern Europe and proposed a remedy (‘Warsaw Declaration’), and the concept of developing a one–stop shop for dealing with academia and industry including the Innovative Medicines Initiative (IMI) was discussed in detail.
Several other dimensions currently lacking were identified. There is an absolute necessity to include the patients’ voice in the establishment of priority areas in cancer research at the present time. It was a salutary lesson when it was recognized that all that is known about the quality of life of the cancer patient comes from the experience of a tiny proportion of cancer patients included in a few clinical trials. The necessity to have dialogue between funders and scientists to establish the best mechanisms to meet the needs of the entire community was evident. A top priority should be the development of translational research (in its widest form) and the development of effective and innovative cancer treatments and preventative strategies in the European Union. Translational research ranges from bench-to-bedside innovative cancer therapies and extends to include bringing about changes in population behaviours when a risk factor is established.
Having taken note of the barriers and the solutions and having examined relevant examples of existing European organizations in the field, it was agreed during the General Assembly of 19 November 2007 that the EUROCAN+PLUS Project had to recommend the creation of a small, permanent and neutral ECI. This should be a model structure and was widely supported at both General Assemblies of the project. The proposal is based on the successful model of the European Molecular Biology Organisation (EMBO), and its principal aims include providing a forum where researchers from all backgrounds and from all countries can meet with members of other specialities including patients, nurses, clinicians, funders and scientific administrators to develop priority programmes to make Europe more competitive in research and more focused on the cancer patient.
The ECI should assume responsibility for: stimulating innovative cancer research and facilitating processes;becoming the common voice of the cancer research community and serving as an interface between the cancer research community and European citizens, patients’ and organizations;European institutions, Member States, industry and small and medium enterprises;putting into practice the aforementioned solutions aimed at alleviating barriers and coordinating cancer research activities in the EU;dealing with legal and regulatory issues.
Solutions implemented through the ECI will lead to better coordination and collaboration throughout Europe, more efficient use of resources, an increase in Europe’s attractiveness to the biomedical industry and better quality of cancer research and education of health professionals.
The Project considered that European legal instruments currently available were inadequate for addressing many aspects of the barriers identified and for the implementation of effective, lasting solutions. Therefore, the legal environment that could shelter an idea like the ECI remains to be defined but should be done so as a priority. In this context, the initiative of the European Commission for a new legal entity for research infrastructure might be a step in this direction. The development of an effective ECI will require time, but this should be established immediately. As an initial step, coordination efforts should be directed towards the creation of a platform on translational research that could encompass: (1) coordination between basic, clinical and epidemiological research; (2) formal agreements of co-operation between comprehensive cancer centres and basic research laboratories throughout Europe; (3) networking between funding bodies at the European level. Another topic deserving immediate attention is the creation of a European database on cancer research projects and cancer research facilities.
Despite enormous progress in cancer control in Europe during the past two decades, there was an increase of 300,000 in the number of new cases of cancer diagnosed between 2004 and 2006. The European Parliament and its instruments have had a major influence in cancer control, notably in tobacco control and in the implementation of effective population–based screening. To make further progress there is a need for novelty and innovation in cancer research and prevention in Europe, and having a platform such as the ECI, where those involved in all aspects of cancer research can meet, discuss and interact, is a decisive development for Europe.
doi:10.3332/ecancer.2011.84
PMCID: PMC3234055  PMID: 22274749
19.  Training the biomedical informatics workforce in Latin America: results of a needs assessment 
BMJ Open  2011;1(2):e000233.
Objective
To report the results of a needs assessment of research and training in Medical Informatics (MI) and Bioinformatics (BI) in Latin America.
Methods and results
This assessment was conducted by QUIPU: The Andean Global Health Informatics Research and Training Center. After sending email invitations to MI–BI related professionals from Latin America, 142 surveys were received from 11 Latin American countries. The following were the top four ranked MI-related courses that a training programme should include: introduction to biomedical informatics; data representation and databases; mobile health; and courses that address issues of security, confidentiality and privacy. Several new courses and topics for research were suggested by survey participants. The information collected is guiding the development of curricula and a research agenda for the MI and BI QUIPU multidisciplinary programme for the Andean Region and Latin America.
Article summary
Article focus
The objective of this paper is to report the results of the first needs assessment of research and training in Medical Informatics (MI) and Bioinformatics (BI) in Latin America.
Key messages
Top ranked courses in biomedical informatics included: mobile health, issues on security, confidentiality and privacy, public and clinical informatics and electronic health records.
The information collected in this needs assessment is guiding the development of curricula and a research agenda for training and research in the Andean region through the Peruvian NIH funded centre QUIPU. ‘Quipu’ is a Quechua word that describes an ancient system used throughout the Andes by the Incas to record and distribute information.
Strengths and limitations of this study
The online survey included participants from 11 Latin American countries.
It is the first needs assessment in Latin America addressing issues of training and research in biomedical informatics.
The sample was, however, purposive.
doi:10.1136/bmjopen-2011-000233
PMCID: PMC3208899  PMID: 22080537
20.  Developing capacity in health informatics in a resource poor setting: lessons from Peru 
The public sectors of developing countries require strengthened capacity in health informatics. In Peru, where formal university graduate degrees in biomedical and health informatics were lacking until recently, the AMAUTA Global Informatics Research and Training Program has provided research and training for health professionals in the region since 1999. The Fogarty International Center supports the program as a collaborative partnership between Universidad Peruana Cayetano Heredia in Peru and the University of Washington in the United States of America. The program aims to train core professionals in health informatics and to strengthen the health information resource capabilities and accessibility in Peru. The program has achieved considerable success in the development and institutionalization of informatics research and training programs in Peru. Projects supported by this program are leading to the development of sustainable training opportunities for informatics and eight of ten Peruvian fellows trained at the University of Washington are now developing informatics programs and an information infrastructure in Peru. In 2007, Universidad Peruana Cayetano Heredia started offering the first graduate diploma program in biomedical informatics in Peru.
doi:10.1186/1478-4491-7-80
PMCID: PMC2777845  PMID: 19860918
21.  Reinterpreting Ethnic Patterns among White and African American Men Who Inject Heroin: A Social Science of Medicine Approach 
PLoS Medicine  2006;3(10):e452.
Background
Street-based heroin injectors represent an especially vulnerable population group subject to negative health outcomes and social stigma. Effective clinical treatment and public health intervention for this population requires an understanding of their cultural environment and experiences. Social science theory and methods offer tools to understand the reasons for economic and ethnic disparities that cause individual suffering and stress at the institutional level.
Methods and Findings
We used a cross-methodological approach that incorporated quantitative, clinical, and ethnographic data collected by two contemporaneous long-term San Francisco studies, one epidemiological and one ethnographic, to explore the impact of ethnicity on street-based heroin-injecting men 45 years of age or older who were self-identified as either African American or white. We triangulated our ethnographic findings by statistically examining 14 relevant epidemiological variables stratified by median age and ethnicity. We observed significant differences in social practices between self-identified African Americans and whites in our ethnographic social network sample with respect to patterns of (1) drug consumption; (2) income generation; (3) social and institutional relationships; and (4) personal health and hygiene. African Americans and whites tended to experience different structural relationships to their shared condition of addiction and poverty. Specifically, this generation of San Francisco injectors grew up as the children of poor rural to urban immigrants in an era (the late 1960s through 1970s) when industrial jobs disappeared and heroin became fashionable. This was also when violent segregated inner city youth gangs proliferated and the federal government initiated its “War on Drugs.” African Americans had earlier and more negative contact with law enforcement but maintained long-term ties with their extended families. Most of the whites were expelled from their families when they began engaging in drug-related crime. These historical-structural conditions generated distinct presentations of self. Whites styled themselves as outcasts, defeated by addiction. They professed to be injecting heroin to stave off “dopesickness” rather than to seek pleasure. African Americans, in contrast, cast their physical addiction as an oppositional pursuit of autonomy and pleasure. They considered themselves to be professional outlaws and rejected any appearance of abjection. Many, but not all, of these ethnographic findings were corroborated by our epidemiological data, highlighting the variability of behaviors within ethnic categories.
Conclusions
Bringing quantitative and qualitative methodologies and perspectives into a collaborative dialog among cross-disciplinary researchers highlights the fact that clinical practice must go beyond simple racial or cultural categories. A clinical social science approach provides insights into how sociocultural processes are mediated by historically rooted and institutionally enforced power relations. Recognizing the logical underpinnings of ethnically specific behavioral patterns of street-based injectors is the foundation for cultural competence and for successful clinical relationships. It reduces the risk of suboptimal medical care for an exceptionally vulnerable and challenging patient population. Social science approaches can also help explain larger-scale patterns of health disparities; inform new approaches to structural and institutional-level public health initiatives; and enable clinicians to take more leadership in changing public policies that have negative health consequences.
Bourgois and colleagues found that the African American and white men in their study had a different pattern of drug use and risk behaviors, adopted different strategies for survival, and had different personal histories.
Editors' Summary
Background.
There are stark differences in the health of different ethnic groups in America. For example, the life expectancy for white men is 75.4 years, but it is only 69.2 years for African-American men. The reasons behind these disparities are unclear, though there are several possible explanations. Perhaps, for example, different ethnic groups are treated differently by health professionals (with some groups receiving poorer quality health care). Or maybe the health disparities are due to differences across ethnic groups in income level (we know that richer people are healthier). These disparities are likely to persist unless we gain a better understanding of how they arise.
Why Was This Study Done?
The researchers wanted to study the health of a very vulnerable community of people: heroin users living on the streets in the San Francisco Bay Area. The health status of this community is extremely poor, and its members are highly stigmatized—including by health professionals themselves. The researchers wanted to know whether African American men and white men who live on the streets have a different pattern of drug use, whether they adopt varying strategies for survival, and whether they have different personal histories. Knowledge of such differences would help the health community to provide more tailored and culturally appropriate interventions. Physicians, nurses, and social workers often treat street-based drug users, especially in emergency rooms and free clinics. These health professionals regularly report that their interactions with street-based drug users are frustrating and confrontational. The researchers hoped that their study would help these professionals to have a better understanding of the cultural backgrounds and motivations of their drug-using patients.
What Did the Researchers Do and Find?
Over the course of six years, the researchers directly observed about 70 men living on the streets who injected heroin as they went about their usual lives (this type of research is called “participant observation”). The researchers specifically looked to see whether there were differences between the white and African American men. All the men gave their consent to be studied in this way and to be photographed. The researchers also studied a database of interviews with almost 7,000 injection drug users conducted over five years, drawing out the data on differences between white and African men. The researchers found that the white men were more likely to supplement their heroin use with inexpensive fortified wine, while African American men were more likely to supplement heroin with crack. Most of the white men were expelled from their families when they began engaging in drug-related crime, and these men tended to consider themselves as destitute outcasts. African American men had earlier and more negative contact with law enforcement but maintained long-term ties with their extended families, and these men tended to consider themselves as professional outlaws. The white men persevered less in attempting to find a vein in which to inject heroin, and so were more likely to inject the drug directly under the skin—this meant that they were more likely to suffer from skin abscesses. The white men generated most of their income from panhandling (begging for money), while the African American men generated most of their income through petty crime and/or through offering services such as washing car windows at gas stations.
What Do These Findings Mean?
Among street-based heroin users, there are important differences between white men and African American men in the type of drugs used, the method of drug use, their social backgrounds, the way in which they identify themselves, and the health risks that they take. By understanding these differences, health professionals should be better placed to provide tailored and appropriate care when these men present to clinics and emergency rooms. As the researchers say, “understanding of different ethnic populations of drug injectors may reduce difficult clinical interactions and resultant physician frustration while improving patient access and adherence to care.” One limitation of this study is that the researchers studied one specific community in one particular area of the US—so we should not assume that their findings would apply to street-based heroin users elsewhere.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030452.
The US Centers for Disease Control (CDC) has a web page on HIV prevention among injection drug users
The World Health Organization has collected documents on reducing the risk of HIV in injection drug users and on harm reduction approaches
The International Harm Reduction Association has information relevant to a global audience on reducing drug-related harm among individuals and communities
US-focused information on harm reduction is available via the websites of the Harm Reduction Coalition and the Chicago Recovery Alliance
Canada-focused information can be found at the Street Works Web site
The Harm Reduction Journal publishes open-access articles
The CDC has a web page on eliminating racial and ethnic health disparities
The Drug Policy Alliance has a web page on drug policy in the United States
doi:10.1371/journal.pmed.0030452
PMCID: PMC1621100  PMID: 17076569
22.  A core curriculum for clinical fellowship training in pathology informatics 
Background:
In 2007, our healthcare system established a clinical fellowship program in Pathology Informatics. In 2010 a core didactic course was implemented to supplement the fellowship research and operational rotations. In 2011, the course was enhanced by a formal, structured core curriculum and reading list. We present and discuss our rationale and development process for the Core Curriculum and the role it plays in our Pathology Informatics Fellowship Training Program.
Materials and Methods:
The Core Curriculum for Pathology Informatics was developed, and is maintained, through the combined efforts of our Pathology Informatics Fellows and Faculty. The curriculum was created with a three-tiered structure, consisting of divisions, topics, and subtopics. Primary (required) and suggested readings were selected for each subtopic in the curriculum and incorporated into a curated reading list, which is reviewed and maintained on a regular basis.
Results:
Our Core Curriculum is composed of four major divisions, 22 topics, and 92 subtopics that cover the wide breadth of Pathology Informatics. The four major divisions include: (1) Information Fundamentals, (2) Information Systems, (3) Workflow and Process, and (4) Governance and Management. A detailed, comprehensive reading list for the curriculum is presented in the Appendix to the manuscript and contains 570 total readings (current as of March 2012).
Discussion:
The adoption of a formal, core curriculum in a Pathology Informatics fellowship has significant impacts on both fellowship training and the general field of Pathology Informatics itself. For a fellowship, a core curriculum defines a basic, common scope of knowledge that the fellowship expects all of its graduates will know, while at the same time enhancing and broadening the traditional fellowship experience of research and operational rotations. For the field of Pathology Informatics itself, a core curriculum defines to the outside world, including departments, companies, and health systems considering hiring a pathology informatician, the core knowledge set expected of a person trained in the field and, more fundamentally, it helps to define the scope of the field within Pathology and healthcare in general.
doi:10.4103/2153-3539.100364
PMCID: PMC3445301  PMID: 23024890
Clinical informatics curriculum; clinical informatics teaching; informatics core content; informatics curriculum; pathology informatics core content; pathology informatics curriculum; pathology informatics definition; pathology informatics fellowship; pathology informatics teaching; pathology informatics
23.  E-Learning as New Method of Medical Education 
Acta Informatica Medica  2008;16(2):102-117.
CONFLICT OF INTEREST: NONE DECLARED
Distance learning refers to use of technologies based on health care delivered on distance and covers areas such as electronic health, tele-health (e-health), telematics, telemedicine, tele-education, etc. For the need of e-health, telemedicine, tele-education and distance learning there are various technologies and communication systems from standard telephone lines to the system of transmission digitalized signals with modem, optical fiber, satellite links, wireless technologies, etc. Tele-education represents health education on distance, using Information Communication Technologies (ICT), as well as continuous education of a health system beneficiaries and use of electronic libraries, data bases or electronic data with data bases of knowledge. Distance learning (E-learning) as a part of tele-education has gained popularity in the past decade; however, its use is highly variable among medical schools and appears to be more common in basic medical science courses than in clinical education. Distance learning does not preclude traditional learning processes; frequently it is used in conjunction with in-person classroom or professional training procedures and practices. Tele-education has mostly been used in biomedical education as a blended learning method, which combines tele-education technology with traditional instructor-led training, where, for example, a lecture or demonstration is supplemented by an online tutorial. Distance learning is used for self-education, tests, services and for examinations in medicine i.e. in terms of self-education and individual examination services. The possibility of working in the exercise mode with image files and questions is an attractive way of self education. Automated tracking and reporting of learners’ activities lessen faculty administrative burden. Moreover, e-learning can be designed to include outcomes assessment to determine whether learning has occurred. This review article evaluates the current status and level of tele-education development in Bosnia and Herzegovina outlining its components, faculty development needs for implementation and the possibility of its integration as official learning standard in biomedical curricula in Bosnia and Herzegovina. Tele-education refers to the use of information and communication technologies (ICT) to enhance knowledge and performance. Tele-education in biomedical education is widely accepted in the medical education community where it is mostly integrated into biomedical curricula forming part of a blended learning strategy. There are many biomedical digital repositories of e-learning materials worldwide, some peer reviewed, where instructors or developers can submit materials for widespread use. First pilot project with the aim to introduce tele-education in biomedical curricula in Bosnia and Herzegovina was initiated by Department for Medical Informatics at Medical Faculty in Sarajevo in 2002 and has been developing since. Faculty member’s skills in creating tele-education differ from those needed for traditional teaching and faculty rewards must recognize this difference and reward the effort. Tele-education and use of computers will have an impact of future medical practice in a life long learning. Bologna process, which started last years in European countries, provide us to promote and introduce modern educational methods of education at biomedical faculties in Bosnia and Herzegovina. Cathedra of Medical informatics and Cathedra of Family medicine at Medical Faculty of University of Sarajevo started to use Web based education as common way of teaching of medical students. Satisfaction with this method of education within the students is good, but not yet suitable for most of medical disciplines at biomedical faculties in Bosnia and Herzegovina.
doi:10.5455/aim.2008.16.102-117
PMCID: PMC3789161  PMID: 24109154
Medical education; Distance learning; Bosnia and Herzegovina
24.  Building better connections: the National Library of Medicine and public health 
Purpose: The paper describes the expansion of the public health programs and services of the National Library of Medicine (NLM) in the 1990s and provides the context in which NLM's public health outreach programs arose and exist today.
Brief Description: Although NLM has always had collections and services relevant to public health, the US public health workforce made relatively little use of the library's information services and programs in the twentieth century. In the 1990s, intensified emphases on outreach to health professionals, building national information infrastructure, and promoting health data standards provided NLM with new opportunities to reach the public health community. A seminal conference cosponsored by NLM in 1995 produced an agenda for improving public health access to and use of advanced information technology and electronic information services. NLM actively pursued this agenda by developing new services and outreach programs and promoting public health informatics initiatives.
Method: Historical analysis is presented.
Results/Outcome: NLM took advantage of a propitious environment to increase visibility and understanding of public health information challenges and opportunities. The library helped create partnerships that produced new information services, outreach initiatives, informatics innovations, and health data policies that benefit the public health workforce and the diverse populations it serves.
doi:10.3163/1536-5050.95.3.293
PMCID: PMC1924934  PMID: 17641764
25.  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

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