Ontological approach to the knowledge systematization of a toxic process and toxic course representation framework for early drug risk management.

Various types of drug toxicity can halt the development of a drug. Because drugs are xenobiotics, they inherently have the potential to cause injury. Clarifying the mechanisms of toxicity to evaluate and manage drug safety during drug development is extremely important. However, toxicity mechanisms, especially hepatotoxic mechanisms, are very complex. The significant exposure of liver cells to drugs can cause dysfunction, cell injury, and organ failure in the liver. To clarify potential risks in drug safety management, it is necessary to systematize knowledge from a consistent viewpoint. In this study, we adopt an ontological approach. Ontology provides a controlled vocabulary for sharing and reusing of various data with a computer-friendly manner. We focus on toxic processes, especially hepatotoxic processes, and construct the toxic process ontology (TXPO). The TXPO systematizes knowledge concerning hepatotoxic courses with consistency and no ambiguity. In our application study, we developed a toxic process interpretable knowledge system (TOXPILOT) to bridge the gaps between basic science and medicine for drug safety management. Using semantic web technology, TOXPILOT supports the interpretation of toxicity mechanisms and provides visualizations of toxic courses with useful information based on ontology. Our system will contribute to various applications for drug safety evaluation and management.

[Opportunities and challenges of blockchain technology in the healthcare industry]. / Opportunités et enjeux de la technologie blockchain dans le secteur de la santé.

Often described as a tool to build trust among stakeholders with divergent interests, blockchain technology has been of interest to many sectors since it was first used in 2008. Initially designed to record financial transactions between individuals, its applications have largely evolved with technological advances and the growing interest of international companies. In the healthcare sector, blockchain is interesting for many of its features: its immutability which makes it an excellent support for authenticating sensitive data such as clinical trials consents, the possibility of publishing smart contracts that automate and facilitate many processes or the constitution of a network that agrees on the state of the information. Much acclaimed, blockchain technology is still to be tested in real-life conditions and adapted to a particularly complex regulatory and economic context in the healthcare sector.

Should biomedical research be like Airbnb?

The thesis presented here is that biomedical research is based on the trusted exchange of services. That exchange would be conducted more efficiently if the trusted software platforms to exchange those services, if they exist, were more integrated. While simpler and narrower in scope than the services governing biomedical research, comparison to existing internet-based platforms, like Airbnb, can be informative. We illustrate how the analogy to internet-based platforms works and does not work and introduce The Commons, under active development at the National Institutes of Health (NIH) and elsewhere, as an example of the move towards platforms for research.

Dental Quality Measurement--A Practitioner Perspective.

This article reviews the HealthPartners Dental Group's experience with clinical quality measurement and provides information on the administrative infrastructure that supports measurement within the group. Some examples of the role measurement plays in operations and clinical practice are also reviewed.

Reducing Patient Clinical Management Errors Using Structured Content and Electronic Nursing Handover.

We examined whether an integrated nursing handover system-structured content and an electronic tool within the patient clinical information system with bedside delivery-would improve the quality of information delivered at nursing handover and reduce adverse patient outcomes. Using a pre/posttest evaluative design, improvements in the transfer of critical patient information and reductions in nursing clinical management incidents were demonstrated. No changes in falls or medication incident rates were identified.

A modular informatics platform for effective support of collaborative and multicenter studies in cardiology.

Collaborative and multicenter studies permit a large number of patients to be enrolled within a reasonable time and providing the opportunity to collect different data. Informatics platforms play an important role in management, storage, and exchange of data between the participants involved in the study. In this article, we describe a modular informatics platform designed and developed to support collaborative and multicenter studies in cardiology. In each developed module, data management is implemented following local defined protocols. The modular characteristic of the developed platform allows independent transfer of different kinds of data, such as biological samples, imaging raw data, and patients' digital information. Moreover, it offers safe central storage of the data collected during the study. The developed platform was successfully tested during a European collaborative and multicenter study, focused on evaluating multimodal non-invasive imaging to diagnose and characterize ischemic heart disease.

Does introduction of a Patient Data Management System (PDMS) improve the financial situation of an intensive care unit?

BACKGROUND: Patient Data Management Systems (PDMS) support clinical documentation at the bedside and have demonstrated effects on completeness of patient charting and the time spent on documentation. These systems are costly and raise the question if such a major investment pays off. We tried to answer the following questions: How do costs and revenues of an intensive care unit develop before and after introduction of a PDMS? Can higher revenues be obtained with improved PDMS documentation? Can we present cost savings attributable to the PDMS? METHODS: Retrospective analysis of cost and reimbursement data of a 25 bed Intensive Care Unit at a German University Hospital, three years before (2004-2006) and three years after (2007-2009) PDMS implementation. RESULTS: Costs and revenues increased continuously over the years. The profit of the investigated ICU was fluctuating over the years and seemingly depending on other factors as well. We found a small increase in profit in the year after the introduction of the PDMS, but not in the following years. Profit per case peaked at 1039 € in 2007, but dropped subsequently to 639 € per case. We found no clear evidence for cost savings after the PDMS introduction. Our cautious calculation did not consider additional labour costs for IT staff needed for system maintenance. CONCLUSIONS: The introduction of a PDMS has probably minimal or no effect on reimbursement. In our case the observed increase in profit was too small to amortize the total investment for PDMS implementation.This may add some counterweight to the literature, where expectations for tools such as the PDMS can be quite unreasonable.

Consensus recommendations for incident learning database structures in radiation oncology.

PURPOSE: Incident learning plays a key role in improving quality and safety in a wide range of industries and medical disciplines. However, implementing an effective incident learning system is complex, especially in radiation oncology. One current barrier is the lack of technical standards to guide users or developers. This report, the product of an initiative by the Work Group on Prevention of Errors in Radiation Oncology of the American Association of Physicists in Medicine, provides technical recommendations for the content and structure of incident learning databases in radiation oncology. METHODS: A panel of experts was assembled and tasked with developing consensus recommendations in five key areas: definitions, process maps, severity scales, causality taxonomy, and data elements. Experts included representatives from all major North American radiation oncology organizations as well as users and developers of public and in-house reporting systems with over two decades of collective experience. Recommendations were developed that take into account existing incident learning systems as well as the requirements of outside agencies. RESULTS: Consensus recommendations are provided for the five major topic areas. In the process mapping task, 91 common steps were identified for external beam radiation therapy and 88 in brachytherapy. A novel feature of the process maps is the identification of "safety barriers," also known as critical control points, which are any process steps whose primary function is to prevent errors or mistakes from occurring or propagating through the radiotherapy workflow. Other recommendations include a ten-level medical severity scale designed to reflect the observed or estimated harm to a patient, a radiation oncology-specific root causes table to facilitate and regularize root-cause analyses, and recommendations for data elements and structures to aid in development of electronic databases. Also presented is a list of key functional requirements of any reporting system. CONCLUSIONS: Incident learning is recognized as an invaluable tool for improving the quality and safety of treatments. The consensus recommendations in this report are intended to facilitate the implementation of such systems within individual clinics as well as on broader national and international scales.

["Veille sanitaire": tools, functions, process of healthcare monitoring in France]. / Veille sanitaire : outils, fonctions, processus.

In France, the term "veille sanitaire" is widely used to designate healthcare monitoring. It contains, however, a set of concepts that are not shared equally by the entire scientific community. The same is true for activities that are part of it, even if some (surveillance for example) are already well defined. Concepts such as "observation", "vigilance", "alert" for example are not always clear. Furthermore, the use of these words in everyday language maintains this ambiguity. Thus, it seemed necessary to recall these definitions as already used in the literature or legislation texts and to make alternative suggestions. This formalization cannot be carried out without thinking about the structure of "veille sanitaire" and its components. Proposals are provided bringing out concepts of formated "veille" (monitoring) and non-formatted "veille" (monitoring). Definitions, functions, (methods and tools, processes) of these two components are outlined here as well as the cooperative relationship they sustain. The authors have attempted to provide the scientific community with a reference framework useful for exchanging information to promote research and methodological development dedicated to this public health application of epidemiology.

[French hospital discharge database: data production, validity, and origins of errors in the field of severe maternal morbidity]. / Le programme de médicalisation du système d'information (PMSI) - processus de production des données, validité et sources d'erreurs dans le domaine de la morbidité maternelle sévère.

BACKGROUND: The organization of obstetric care in France brings all women in contact with the hospital system. Thus, hospital discharge data from the Program of Medicalization of the Information System (PMSI) constitute a potentially valuable source of information, particularly regarding rare events such as severe maternal morbidity. These data cover a large population but their quality has not been assessed in that field. Our objectives were to study the processes of production and the validity of PMSI data related to severe maternal morbidity. METHODS: The study was conducted in four French tertiary teaching hospitals (Caen, Cochin [AP-HP, Paris], Grenoble and Lille). First, the organization of each step of the medical information process -production, formatting, verification and processing- was detailed in each center with a standardized form. Second, the validation study was based on the comparison of data related to severe maternal morbid events in the PMSI from these centers for 2006 and 2007, with the content of medical records which constituted the gold standard. Indicators of sensitivities and positive predictive values of PMSI were calculated. RESULTS: The processes of PMSI data production showed major differences between the four centers. In hospital discharge data, diagnoses (eclampsia and pulmonary embolism) had a high proportion of false-positives (68%). Inversely, procedures (four procedures for management of severe haemorrhage) had less than 1% of false-positives, but a low sensitivity with 37% false-negatives which could be corrected in 95%. Regarding intensive care provision, all indicators of hospital data quality were very high. In addition, the validity of hospital data in centers 1 and 2 was higher for all events. CONCLUSION: The heterogeneity of the process of PMSI data production is associated with a variable quality of these data. Intensive care provision can be used in the PMSI, as well as procedures after correction. For diagnoses, the quality of the PMSI data is better in centers having both computerized medical records and steps for verification of medical information.

Laboratory and software applications for clinical trials: the global laboratory environment.

The Applied Pharmaceutical Software Meeting is held annually. It is sponsored by The Boston Society, a not-for-profit organization that coordinates a series of meetings within the global pharmaceutical industry. The meeting generally focuses on laboratory applications, but in recent years has expanded to include some software applications for clinical trials. The 2011 meeting emphasized the global laboratory environment. Global clinical trials generate massive amounts of data in many locations that must be centralized and processed for efficient analysis. Thus, the meeting had a strong focus on establishing networks and systems for dealing with the computer infrastructure to support such environments. In addition to the globally installed laboratory information management system, electronic laboratory notebook and other traditional laboratory applications, cloud computing is quickly becoming the answer to provide efficient, inexpensive options for managing the large volumes of data and computing power, and thus it served as a central theme for the meeting.

Rheumatoid arthritis disease severity indices in administrative databases: a systematic review.

OBJECTIVE: We aimed to systematically review rheumatoid arthritis (RA) disease severity indices for use in administrative healthcare databases. We also provide an overview of alternative methods to control for RA disease severity in administrative database research. METHODS: We conducted a systematic review of studies that developed/validated an index for RA disease severity using variables in administrative databases, and compared the convergent validity/reliability of the index with a standard measure of RA severity. RESULTS: After reviewing 539 articles, 2 studies were included. The claims-based index for RA severity (CIRAS) was developed in one study. Components of the CIRAS included tests for inflammatory markers, number of chemistry panels/platelet counts ordered, rheumatoid factor test, number of rehabilitation and rheumatology visits, and Felty's syndrome. The CIRAS correlated moderately well with a previously validated RA medical records-based index of severity. The second study assessed whether current and lifetime treatment with disease-modifying antirheumatic drugs and/or biologics accurately predicted RA severity, as measured by the patient-reported Patient Activity Scale (PAS). Treatment variables did not fully distinguish patients in the highest and lowest quartiles of PAS scores (67.2% correctly classified). CONCLUSION: Two claims-based indices of RA severity were identified but have some limitations for routine use. A concerted effort from experts in the field is needed to define, develop, and validate a widely applicable measure of RA disease severity for administrative database research.

Comparison of patient assistance program software.

PURPOSE: The capabilities of available software programs for the management of applications to patient assistance programs (PAPs) and associated administrative tasks are reported. SUMMARY: Fifteen PAP software programs available at the time of data collection (July-September 2010) were identified through an Internet search and from e-mailed responses to a listserv request. To supplement and confirm the information obtained online, the software makers were contacted; additional data were collected through follow-up correspondence. The survey was restricted to standalone programs; all manufacturer-provided information was assumed to be accurate, and the products were not tested. The 15 software products evaluated (11 Web-based and 4 Windows-based programs) offered a wide range of capabilities to streamline the PAP application process, such as storage of patient and physician profiles, automatic completion of forms with stored data, application status tracking, and customized report generation. The Web-based programs offered some advantages over the Windows-based programs, including greater user accessibility and automatic updates. Product pricing varied widely, depending on the specific licensing terms. Some manufacturers offered discounts to health care organizations participating in the 340B Prime Vendor Program; some offered volume discounts. In addition, grant support may be available to help pay software licensing costs. CONCLUSION: There are at least 15 software programs for streamlining and enhancing the process of PAP application management. No single program can meet the needs of every organization; selecting the right product demands a close look at the needs of an organization and the features and logistics of each program.

On quality assurance and assessment of biological datasets and related statistics.

The complexity of modern biological database management systems indicates the need of integrated metadata repositories for harmonized and high-quality assured data processing. Such systems should allow for the derivation of specific producer-oriented indicators monitoring the quality of the final datasets and statistics provided to the end-users. In this paper, we offer a quality assurance and assessment framework for biological dataset management from both the producers' and users' perspective. In order to assist the producers in high-quality end-results, we consider the integration of a process-oriented data/metadata model enriched with quality declaration metadata, like quality indicators, for the entire process of dataset management. With the automatic manipulation of both data and "quality" metadata, we assure standardization of processes and error detection and reduction. Regarding the user assessment of final results, we discuss trade-offs among certain quality components (such as accuracy, timeliness, relevance, comparability, etc.) and offer indicative user-oriented quality indicators.

Quantitative data management in quality improvement collaboratives.

BACKGROUND: Collaborative approaches in quality improvement have been promoted since the introduction of the Breakthrough method. The effectiveness of this method is inconclusive and further independent evaluation of the method has been called for. For any evaluation to succeed, data collection on interventions performed within the collaborative and outcomes of those interventions is crucial. Getting enough data from Quality Improvement Collaboratives (QICs) for evaluation purposes, however, has proved to be difficult. This paper provides a retrospective analysis on the process of data management in a Dutch Quality Improvement Collaborative. From this analysis general failure and success factors are identified. DISCUSSION: This paper discusses complications and dilemma's observed in the set-up of data management for QICs. An overview is presented of signals that were picked up by the data management team. These signals were used to improve the strategies for data management during the program and have, as far as possible, been translated into practical solutions that have been successfully implemented.The recommendations coming from this study are: From our experience it is clear that quality improvement programs deviate from experimental research in many ways. It is not only impossible, but also undesirable to control processes and standardize data streams. QIC's need to be clear of data protocols that do not allow for change. It is therefore minimally important that when quantitative results are gathered, these results are accompanied by qualitative results that can be used to correctly interpret them.Monitoring and data acquisition interfere with routine. This makes a database collecting data in a QIC an intervention in itself. It is very important to be aware of this in reporting the results. Using existing databases when possible can overcome some of these problems but is often not possible given the change objective of QICs. Introducing a standardized spreadsheet to the teams is a very practical and helpful tool in collecting standardized data within a QIC. It is vital that the spreadsheets are handed out before baseline measurements start.

eCOMPAGT -- efficient combination and management of phenotypes and genotypes for genetic epidemiology.

BACKGROUND: High-throughput genotyping and phenotyping projects of large epidemiological study populations require sophisticated laboratory information management systems. Most epidemiological studies include subject-related personal information, which needs to be handled with care by following data privacy protection guidelines. In addition, genotyping core facilities handling cooperative projects require a straightforward solution to monitor the status and financial resources of the different projects. DESCRIPTION: We developed a database system for an efficient combination and management of phenotypes and genotypes (eCOMPAGT) deriving from genetic epidemiological studies. eCOMPAGT securely stores and manages genotype and phenotype data and enables different user modes with different rights. Special attention was drawn on the import of data deriving from TaqMan and SNPlex genotyping assays. However, the database solution is adjustable to other genotyping systems by programming additional interfaces. Further important features are the scalability of the database and an export interface to statistical software. CONCLUSION: eCOMPAGT can store, administer and connect phenotype data with all kinds of genotype data and is available as a downloadable version at (http://dbis-informatik.uibk.ac.at/ecompagt).

Picture, archiving and communication system in the Italian NHS: a primer on diffusion and evaluation analysis.

This contribution focuses on picture archiving and communication systems (PACS) in the Italian National Healthcare System (NHS). It finally aims to test the Chiefs Radiology Department's perceptions about PACS along the main evaluation dimensions emerging from the literature. First, a brief review of the main literature concerning PACS evaluation leads the authors to classify the different approaches undertaken and highlight the main variables of investigation. Second, the evidence emerging from a survey is presented and discussed in the light of the literature review. The survey aims to: (a) map out the degree of PACSs diffusion and their main features in the Italian NHS; (b) verify whether and how PACS impact the dimensions analyzed in many evaluation studies carried out to date; (c) test the relationship between some measured impacts and specific PACS features.

Standard Operating Procedures, ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?

The use of human biological specimens in scientific research is the focus of current international public and professional concern and a major issue in bioethics in general. Brain/Tissue/Bio banks (BTB-banks) are a rapid developing sector; each of these banks acts locally as a steering unit for the establishment of the local Standard Operating Procedures (SOPs) and the legal regulations and ethical guidelines to be followed in the procurement and dissemination of research specimens. An appropriat Code of Conduct is crucial to a successful operation of the banks and the research application they handle. What are we still missing ? (1) Adequate funding for research BTB-banks. (2) Standard evaluation protocls for audit of BTB-bank performance. (3) Internationally accepted SOP's which will facilitate exchange and sharing of specimens and data with the scientific community. (4) Internationally accepted Code of Conduct. In the present paper we review the most pressing organizational, methodological, medico-legal and ethical issues involved in BTB-banking; funding, auditing, procurement, management/handling, dissemination and sharing of specimens, confidentiality and data protection, genetic testing, "financial gain" and safety measures. Taking into consideration the huge variety of the specimens stored in different repositories and the enormous differences in medico-legal systems and ethics regulations in different countries it is strongly recommend that the health-care systems and institutions who host BTB-Banks will put more efforts in getting adequate funding for the infrastructure and daily activities. The BTB-banks should define evaluation protocols, SOPs and their Code of Conduct. This in turn will enable the banks to share the collected specimens and data with the largest possible number of researchers and aim at a maximal scientific spin-off and advance in public health research.

Global clinical data interchange standards are here!

The Clinical Data Interchange Standards Consortium (CDISC) has succeeded in developing global clinical data interchange standards that are ready for implementation. The various CDISC models are identified and explained in this article as well as how these models work together. In addition to developing the CDISC standards, CDISC is involved actively in many collaborative projects with other organizations as a result of their numerous alliances and partnerships. CDISC standards are supporting not only the pharmaceutical industry but also other initiatives and services in healthcare.

Electronically signed documents in health care--analysis and assessment of data formats and transformation.

OBJECTIVES: Our objectives were to analyze and assess data formats for their suitability for conclusive and secure long-term archiving and to develop a concept for legally secure transformation of electronically signed documents that are not available in data formats appropriate for long-term archiving. METHODS: On the basis of literature review and Internet searches we developed general evaluation criteria to assess data formats with regard to their suitability for conclusive and secure long-term archiving. The assessment of data formats refers to format specifications and available literature. For the analyses of the transformation of signed documents we analyzed legal requirements on the basis of laws and ordinances as well as technical requirements by means of literature reviews, Internet searches and technical specifications. RESULTS: The following evaluation criteria are suited for this kind of assessment of data formats: transparency and standardization, stability, presentation and security. According to our assessment the following data formats are most suitable for conclusive and secure long-term archiving: PDF for formatted and unstructured text documents, XML for markup languages, TIFF for images in general, DICOM for medical images and S/MIME for the storage of e-mail. To transform electronically signed documents we propose an elementary procedure and universal basic model in form of an XML schema definition that includes the necessary legal and technical information. CONCLUSIONS: If electronic documents are to replace paper-based documents in patient records, they have to conform to the criteria for secure long-term archiving. The analyzed data formats are to be extended by mechanisms to guarantee the long-term security of electronic signatures. To transform large quantities of documents in a legally secure way, our basic model has to be extended for automated procedures.