Despont-Gros, Christelle; Bœuf, Christophe; Geissbuhler, Antoine; Lovis, Christian
Evaluation of the technical feasibility of tight integration of the digital pen and paper technology in an existing computerized patient record.Technology: The digital pen is a normal pen able to record all actions of the user and to analyze a micro pattern printed on the paper. The digital paper is a normal paper printed with an almost invisible micro pattern of small dots encoding information such as position and identifiers. We report our experience in the implementation and the use of this technology in an existing large clinical information system for acquiring clinical information. It is possible to print uniquely identified forms using the digital paper technology. These forms can be pre-filled with clinical readable information about the patient. When care providers complete these forms using the digital pen, it is possible to acquire the data in a structured computerized patient record. The technology is easy to integrate in a component-based architecture based on Web Services. The digital pen and paper is a cost-effective technology that can be integrated in an existing clinical information system and allows fast and easy bedside clinical information acquisition without the need for an expensive infrastructure based on traditional portable devices or wireless devices.
Valkenhoef, Gert van; Tervonen, Tommi; Brock, Bert de; Hillege, Hans
Clinical trials provide pivotal evidence on drug efficacy and safety. The evidence, information from clinical trials, is currently used by regulatory decision makers in marketing authorization decisions, but only in an implicit manner. For clinical trials information to be used in a transparent and
Aryanto, Kadek Y. E.; Broekema, Andre; Oudkerk, Matthijs; van Ooijen, Peter M. A.
To present an adapted Clinical Trial Processor (CTP) test set-up for receiving, anonymising and saving Digital Imaging and Communications in Medicine (DICOM) data using external input from the original database of an existing clinical study information system to guide the anonymisation process. Two
Schiodt, Morten; Larsson Wexell, Cecilia; Herlofson, Bente Brokstad
registration form has been developed, and the relevant medical community has been informed either directly or through presentations at professional meetings. A website with study information is published in each country, and data entry is ongoing. This large-scale systematic uniform registration of ONJ cases...
Johannesdottir, Sigrun Alba; Horváth-Puhó, Erzsébet; Ehrenstein, Vera
The Danish health care system provides partial reimbursement of most prescription medications in Denmark. The dispensation of prescription medications is registered in administrative databases. Each time a prescription is redeemed at a pharmacy, an electronic record is generated with information ...
A. I. Trubei
Full Text Available The article provides a survey of the existing regulatory framework for information security riskmanagement. Practical methods for information security risk and vulnerability assessment are proposed.
... Cancer Treatment Types of Cancer Treatment Side Effects Clinical Trials Information A to Z List of Cancer Drugs ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...
Full Text Available One methodology that has met success to infer gene networks from gene expression data is based upon ordinary differential equations (ODE. However new types of data continue to be produced, so it is worthwhile to investigate how to integrate these new data types into the inference procedure. One such data is physical interactions between transcription factors and the genes they regulate as measured by ChIP-chip or ChIP-seq experiments. These interactions can be incorporated into the gene network inference procedure as a priori network information. In this article, we extend the ODE methodology into a general optimization framework that incorporates existing network information in combination with regularization parameters that encourage network sparsity. We provide theoretical results proving convergence of the estimator for our method and show the corresponding probabilistic interpretation also converges. We demonstrate our method on simulated network data and show that existing network information improves performance, overcomes the lack of observations, and performs well even when some of the existing network information is incorrect. We further apply our method to the core regulatory network of embryonic stem cells utilizing predicted interactions from two studies as existing network information. We show that including the prior network information constructs a more closely representative regulatory network versus when no information is provided.
Full Text Available We consider a two-period model in which a continuum of agents trade in a context of costly information acquisition and systematic heterogeneous expectations biases. Because of systematic biases agents are supposed not to learn from others' decisions. In a previous work under somehow strong technical assumptions a market equilibrium was proved to exist and the supply and demand functions were proved to be strictly monotonic with respect to the price. Here we extend these results under very weak technical assumptions. We also prove that the equilibrium price maximizes the trading volume and further additional properties (such as the antimonotonicity of the trading volume with respect to the marginal information price.
... information collection. (2) Title of the Form/Collection: Employment Eligibility Verification. (3) Agency form... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Revision of an Existing Information Collection, Comment Request ACTION: 60-Day notice of information collection under...
... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form N-25, Extension of an Existing Information Collection Request; Comment Request ACTION: 30-Day Notice of Information Collection Under Review: Form N- 25, Request for Verification of Naturalization. The Department of...
... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Extension of an Existing Information Collection Request; Comment Request ACTION: 60-Day Notice of Information Collection Under Review: Form N- 25, Request for Verification of Naturalization. The Department of Homeland...
... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form I-9 CNMI; Revision to an Existing Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection under Review: Form I-9 CNMI, CNMI Employment Eligibility Verification; OMB Control No. 1615- 0112...
Morrison, Frances P; Li, Li; Lai, Albert M; Hripcsak, George
Electronic clinical documentation can be useful for activities such as public health surveillance, quality improvement, and research, but existing methods of de-identification may not provide sufficient protection of patient data. The general-purpose natural language processor MedLEE retains medical concepts while excluding the remaining text so, in addition to processing text into structured data, it may be able provide a secondary benefit of de-identification. Without modifying the system, the authors tested the ability of MedLEE to remove protected health information (PHI) by comparing 100 outpatient clinical notes with the corresponding XML-tagged output. Of 809 instances of PHI, 26 (3.2%) were detected in output as a result of processing and identification errors. However, PHI in the output was highly transformed, much appearing as normalized terms for medical concepts, potentially making re-identification more difficult. The MedLEE processor may be a good enhancement to other de-identification systems, both removing PHI and providing coded data from clinical text.
R. Agus Sartono
Our model shows that the more diverse the information, the higher the lambda coefficient which means the market becomes less liquid. The models consistent with Miller (1977 who found that the bigger the gap of private information is, the less liquid the market will be. If both informed traders have the same information they will demand the same amount of risky asset and it turns out to be similar as in the Kyle (1985 model.
Drawing on the author's experience as an information professional for individuals with disabilities, this article discusses the challenges faced by both library users and staff in obtaining and providing information to this community. It poses four questions: Where do individuals with disabilities fit into diversity studies? Do individuals with…
Department of Veterans Affairs — Clinical Information Support System (CISS) is a web-based portal application that provides a framework of services for the VA enterprise and supplies an integration...
skills within a business that make it more valuable or competitive, https://dictionary.cambridge.org/us/dictionary/ english / skill . Examples of knowledge...MAXIMIZE THEIR EXISTING INFORMATION-RELATED CAPABILITIES AUTHOR: MAJ JAMEL L. NEVILE, USMC AY 15-16 Mentor and Oral Defense... Oral Defense Committee Member: ______________________________________ Approved: ______________________________________ Date
Aug 27, 2009 ... ondersteuning ontvang en dat daar beter oor hulle toesig gehou word. INFORMED CONSENT IN CLINICAL TRIALS: PERCEPTIONS AND. EXPERIENCES OF A SAMPLE OF SOUTH AFRICAN RESEARCHERS. INTRODUCTION. First articulated in the Nuremberg Code in 1947, informed consent (IC) has ...
guidelines that present such data. This report synthesizes these data and provides Districts with information on benchmark designs and installa- tions...adjustment of the North American Vertical Datum. ACSM Bulletin, December, p. 21-22. Jarman, J.T. (1955) Movement of triangulation marks set in permafrost
Siqueira, Carlos E
This editorial argues that informal employment does exist in developed countries and needs to be studied as such to complement the existing literature mostly published on informal work in developing countries. © The Author(s) 2016.
Talbott, Carolyn; Watson, Lynn; Tariman, Joseph; Sorenson, Matthew
To assess the acceptability and usability of a standardised communication tool for nurses. Communication is key in health care. On a daily, if not hourly, basis, nursing staff is inundated with new information regarding tools and resources, practice changes and the work environment. However, there is currently no standardised messaging or delivery method to effectively communicate new information. Even with a plethora of communication tools such as flyers, posters, emails, unit huddles and unit meetings, there is no means to guarantee attendance to crucial information. Descriptive, cross-sectional online survey, implemented at a nonacademic, suburban hospital with 280 nurses. The Clinical Chatter, an online tool developed by nursing leadership to standardise messages regarding the organisation, new tools and resources, professional development, recognition and unit updates, was delivered to each nurse on a weekly basis followed by administration of Acceptability and Usability scales. The Clinical Chatter tool has adequate acceptability and usability as a method of communication among nurses in a hospital organisation. Sociodemographic variables of age and years of experience had no statistically significant association with perceived acceptance and usefulness of the tool. The findings indicate that the Clinical Chatter tool can be used as a standardised communication tool to deliver key information among nurses working in a hospital organisation. Nursing leadership must establish and support a clear communication system to enhance patient care and outcomes and improve nursing job satisfaction. Communication is vital to advancing health care. Lack of communication among nursing has been linked to unsafe patient care: medication errors, unhealthy work environments and decreased nurse retention rates. Clinical Chatter is an effective communication tool for presentation of institutional information to nursing personnel. © 2016 John Wiley & Sons Ltd.
Moreno-Conde, Alberto; Jódar-Sánchez, Francisco; Kalra, Dipak
This study proposes consensus requirements for clinical information modelling tools that can support modelling tasks in medium/large scale institutions. Rather than identify which functionalities are currently available in existing tools, the study has focused on functionalities that should be covered in order to provide guidance about how to evolve the existing tools. After identifying a set of 56 requirements for clinical information modelling tools based on a literature review and interviews with experts, a classical Delphi study methodology was applied to conduct a two round survey in order to classify them as essential or recommended. Essential requirements are those that must be met by any tool that claims to be suitable for clinical information modelling, and if we one day have a certified tools list, any tool that does not meet essential criteria would be excluded. Recommended requirements are those more advanced requirements that may be met by tools offering a superior product or only needed in certain modelling situations. According to the answers provided by 57 experts from 14 different countries, we found a high level of agreement to enable the study to identify 20 essential and 21 recommended requirements for these tools. It is expected that this list of identified requirements will guide developers on the inclusion of new basic and advanced functionalities that have strong support by end users. This list could also guide regulators in order to identify requirements that could be demanded of tools adopted within their institutions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Feb 17, 2004 ... ingly to censure him, distraught that he had betrayed the trust and confidence of a patient, which they .... tion officer, whereas the heads of private bodies have to deal with requests for information. Contrary to a ... If the information officer or head of private body is of the opinion that information may cause ...
The objective of this study is to systematically evaluate the Iowa Department of Transportations (DOTs) existing Pavement Management Information System (PMIS) with respect to the input information required for Mechanistic-Empirical Pavement Des...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... Immigration and Customs Enforcement (ICE), will submit the following information collection request for review... Immigration and Customs Enforcement, Department of Homeland Security, and sent via electronic mail to...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... Immigration and Customs Enforcement (ICE), will be submitting the following information collection request for... Immigration and Customs Enforcement, Department of Homeland Security, and sent via electronic mail to oira...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF LABOR Mine Safety and Health Administration Proposed Extension of Existing Information Collection; Emergency Mine Evacuation AGENCY: Mine Safety and Health Administration, Labor. ACTION: Request for public comments. SUMMARY...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF LABOR Mine Safety and Health Administration Proposed Extension of Existing Information Collection; Rock Burst Control Plan, Metal and Nonmetal Mines AGENCY: Mine Safety and Health Administration, Labor. ACTION...
... Security (DHS), Student and Exchange Visitor Program (SEVP) office within 30 days of admission. (5) An... Information Collection for Review; File No. I- 515A, Notice to Student or Exchange Visitor; OMB Control No... currently approved information collection. (2) Title of the Form/Collection: Notice to Student or Exchange...
... appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information..., cashier's check, certified check or ] money order, he or she is issued a Receipt of Immigration Officer--U...
... initially complete and prepare an IMAGE application so that ICE can properly evaluate the company for... the following four points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will submit the following information... Managment, U.S. Immigration and Customs Enforcement, 801 I Street NW., Stop 5800, Washington, DC 20536; (202...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... Immigration and Customs Enforcement (USICE), has submitted the following information collection request for... Management Branch, U.S. Immigration and Customs Enforcement, 500 12th Street, SW., Room 3138, Washington, DC...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will submit the following information..., Management and Program Analyst, U.S. Immigration and Customs Enforcement, 500 12th Street SW., Stop 5705...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will submit the following information..., Chief, Records Management, U.S. Immigration and Customs Enforcement, 500 12th Street SW., Stop 5705...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will submit the following information..., Chief, Records Management, U.S. Immigration and Customs Enforcement, 500 12th Street SW., Stop 5705...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... Immigration and Customs Enforcement (USICE), will be submitting the following information collection request... Management Branch, U.S. Immigration and Customs Enforcement, 500 12th Street, SW., STOP 5705 Washington, DC...
... Requested ACTION: 60-Day Notice of Information Collection Under Review: Approval of a existing collection; The National Instant Criminal Background Check System (NICS) Point of Contact (POC) State Final...), Criminal Justice Information Services (CJIS) Division's NICS Section will be submitting the following...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities..., * * * * * The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will be... should be addressed to OMB Desk Officer, for United States Immigration and Customs Enforcement...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Department of Homeland Security, U.S. Immigration and Customs Enforcement (USICE), will submit the following... United States Immigration and Customs Enforcement, Department of Homeland Security, and sent via...
Hall, Daniel E; Prochazka, Allan V; Fink, Aaron S
... used in this review is available in Box 1. (1) Although we had hoped to identify high-quality studies that would provide a strong quantitative base of evidence for recommendations around informed consent, much of the quantitative literature on this topic is descriptive in nature. Informed consent is primarily a legal and ethical concept; althou...
... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form N-336... Collection under Review; Form N- 336, Request for Hearing on a Decision in Naturalization Proceedings Under Section 336; OMB Control No. 1615-0050. The Department of Homeland Security, U.S. Citizenship and...
... SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form N-336... collection under review: Form N- 336, Request for Hearing on a Decision in Naturalization Proceedings Under Section 336; OMB Control No. 1615-0050. On August 18, 2010, USCIS published a 60-day notice in the Federal...
...: Primary: Individuals or Households. When an academic student (F-1), vocational student (M-1), exchange...) Evaluate whether the proposed collection of information is necessary for the proper performance of the... under section 101(a)(15) of the Immigration and Nationality Act (Act), he or she is required to have...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities...-0019. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will be... Officer, for United States Immigration and Customs Enforcement, Department of Homeland Security, and sent...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities...-0026. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (USICE), has... collection: Form G-79A, U.S. Immigration and Customs Enforcement. (4) Affected public who will be asked or...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... The Department of Homeland Security, U.S. Immigration and Customs Enforcement (USICE), will be... collection: U.S. Immigration and Customs Enforcement. (4) Affected public who will be asked or required to...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... The Department of Homeland Security, U.S. Immigration and Customs Enforcement (USICE), will submit the... Desk Officer for U.S. Immigration and Customs Enforcement, Department of Homeland Security, and sent...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... 1653- 0019. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), is.... Comments should be addressed to OMB Desk Officer, for United States Immigration and Customs Enforcement...
... SECURITY U.S. Immigration and Customs Enforcement Agency Information Collection Activities: Extension of an... Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will be submitting the... Officer/OAA/Records Branch, U.S. Immigration and Customs Enforcement, 500 12th Street, SW., STOP 5705...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will submit the following... Mattison, Chief, Records Management, U.S. Immigration and Customs Enforcement, 500 12th Street SW., Stop...
... SECURITY U. S. Immigration and Customs Enforcement Agency Information Collection Activities: Extension of... Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will be submitting the following.../Records Branch, U.S. Immigration and Customs Enforcement, 500 12th Street, SW., STOP 5705 Washington, DC...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will be... collection: Forms I-17 and I-20; U.S. Immigration and Customs Enforcement. (4) Affected public who will be...
... SECURITY U. S. Immigration and Customs Enforcement Agency Information Collection Activities: Extension of.... The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will be... Budget. Comments should be addressed to OMB Desk Officer, for U.S. Immigration and Customs Enforcement...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will submit the... addressed to OMB Desk Officer, for United States Immigration and Customs Enforcement, Department of Homeland...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will submit the following... Mattison, Chief, Records Management, U.S. Immigration and Customs Enforcement, 500 12th Street SW., Stop...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... 1653-0048. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will... addressed to the OMB Desk Officer for U.S. Immigration and Customs Enforcement, Department of Homeland...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Control No. 1653-0040. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE... Office of the Chief Financial Officer/OAA/Records Branch, U.S. Immigration and Customs Enforcement, 500...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Control No. 1653-0026. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE.... Comments should be addressed to OMB Desk Officer, for United States Immigration and Customs Enforcement...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities...-0019. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will be... Chief Financial Officer/OAM/Records Branch, U.S. Immigration and Customs Enforcement, 500 12th Street...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... ] The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will submit the... Security (DHS), John Ramsay, Program Manager, U.S. Immigration and Customs Enforcement, 500 12th Street SW...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... 1653- 0019). The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), is... should be addressed to OMB Desk Officer, for United States Immigration and Customs Enforcement...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will submit the following... Officer, for United States Immigration and Customs Enforcement, Department of Homeland Security, and sent...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities...-0026. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will be... Financial Officer/OAA/Records Branch, U.S. Immigration and Customs Enforcement, 500 12th Street, SW., STOP...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... The Department of Homeland Security, U.S. Immigration and Customs Enforcement (USICE), will submit the...), Scott Elmore, Forms Manager, U.S. Immigration and Customs Enforcement, 801 I Street NW., Mailstop 5800...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... 1653- 0043. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will... should be addressed to OMB Desk Officer, for United States Immigration and Customs Enforcement...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities.... Immigration and Customs Enforcement, 500 12th Street SW., Stop 5705, Washington, DC 20536; (202) 732-4356... Management, U.S. Immigration and Customs Enforcement, 500 12th Street SW., Stop 5705, Washington, DC 20536...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities... Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE), will submit the following... Mattison, Chief, Records Management, U.S. Immigration and Customs Enforcement, 500 12th Street SW., Stop...
... SECURITY United States Immigration and Customs Enforcement Agency Information Collection Activities...-0026. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (USICE), has... should be addressed to OMB Desk Officer, for U. S. Immigration and Customs Enforcement, Department of...
Masanes, Lluís; Müller, Markus P; Augusiak, Remigiusz; Pérez-García, David
Does information play a significant role in the foundations of physics? Information is the abstraction that allows us to refer to the states of systems when we choose to ignore the systems themselves. This is only possible in very particular frameworks, like in classical or quantum theory, or more generally, whenever there exists an information unit such that the state of any system can be reversibly encoded in a sufficient number of such units. In this work, we show how the abstract formalism of quantum theory can be deduced solely from the existence of an information unit with suitable properties, together with two further natural assumptions: the continuity and reversibility of dynamics, and the possibility of characterizing the state of a composite system by local measurements. This constitutes a set of postulates for quantum theory with a simple and direct physical meaning, like the ones of special relativity or thermodynamics, and it articulates a strong connection between physics and information.
Spackman, K A
Multitasking operating systems and expanding networks now permit smooth access to remote computers, peripherals, data, and information resources. Graphic user interfaces and productivity-enhancing software packages reduce the need for training and memorization of commands. New models of desktop computers based on "data-centered" software architecture can enhance workstation usefulness even more. Pathologists need to consider how these tools might improve access to and management of information and knowledge.
Full Text Available Helene Nørrelund, Wiktor Mazin, Lars Pedersen Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark Abstract: Denmark is facing a reduction in clinical trial activity as the pharmaceutical industry has moved trials to low-cost emerging economies. Competitiveness in industry-sponsored clinical research depends on speed, quality, and cost. Because Denmark is widely recognized as a region that generates high quality data, an enhanced ability to attract future trials could be achieved if speed can be improved by taking advantage of the comprehensive national and regional registries. A "single point-of-entry" system has been established to support collaboration between hospitals and industry. When assisting industry in early-stage feasibility assessments, potential trial participants are identified by use of registries to shorten the clinical trial startup times. The Aarhus University Clinical Trial Candidate Database consists of encrypted data from the Danish National Registry of Patients allowing an immediate estimation of the number of patients with a specific discharge diagnosis in each hospital department or outpatient specialist clinic in the Central Denmark Region. The free access to health care, thorough monitoring of patients who are in contact with the health service, completeness of registration at the hospital level, and ability to link all databases are competitive advantages in an increasingly complex clinical trial environment. Keywords: Denmark, single point-of-entry, patient registration
... teach; the location where training will be given for each course; a description of the teaching methods... Safety and Health Administration Proposed Extension of Existing Information Collection; Training Plans and Records of Training AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice of...
... Noise Exposure AGENCY: Mine Safety and Health Administration, Labor. ACTION: Request for public comments... extension of an existing information collection, OMB Control Number 1219-0120, Occupational Noise Exposure... originally titled ``Noise exposure assessment; audiometric testing, evaluation, and records and training in...
... Status Online; Extension of an Existing Information Collection; Comment Request ACTION: 60-Day Notice of... the USCIS Case Status Online. Written comments and suggestions regarding items contained in this... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOMELAND...
... Safety and Health Administration Proposed Extension of Existing Information Collection; Mine Rescue Teams...) to publish regulations which provide that mine rescue teams be available for rescue and recovery work... arrangements for such teams are to be borne by the operator of each such mine. II. Desired Focus of Comments...
... concerning the proposed extension of an existing information collection, OMB Control Number 1219-00040... Control Number 1219- 0040'' and sent to both the Office of Management and Budget (OMB) and MSHA. Comments..., including activities such as clearing land, excavating ore, processing minerals, maintaining, or repairing...
Pascual-Aguilar, J. A.; Rubio, J. L.; Domínguez, J.; Andreu, V.
New information technologies give the possibility of widespread dissemination of spatial information to different geographical scales from continental to local by means of Spatial Data Infrastructures. Also administrative awareness on the need for open access information services has allowed the citizens access to this spatial information through development of legal documents, such as the INSPIRE Directive of the European Union, adapted by national laws as in the case of Spain. The translation of the general criteria of generic Spatial Data Infrastructures (SDI) to thematic ones is a crucial point for the progress of these instruments as large tool for the dissemination of information. In such case, it must be added to the intrinsic criteria of digital information, such as the harmonization information and the disclosure of metadata, the own environmental information characteristics and the techniques employed in obtaining it. In the case of inventories and mapping of soils, existing information obtained by traditional means, prior to the digital technologies, is considered to be a source of valid information, as well as unique, for the development of thematic SDI. In this work, an evaluation of existing and accessible information that constitutes the basis for building a thematic SDI of soils in Spain is undertaken. This information framework has common features to other European Union states. From a set of more than 1,500 publications corresponding to the national territory of Spain, the study was carried out in those documents (94) found for five autonomous regions of northern Iberian Peninsula (Asturias, Cantabria, Basque Country, Navarra and La Rioja). The analysis was performed taking into account the criteria of soil mapping and inventories. The results obtained show a wide variation in almost all the criteria: geographic representation (projections, scales) and geo-referencing the location of the profiles, map location of profiles integrated with edaphic
Diabetes co-existing with chronic liver disease: Clinical features and response to therapy. EK Chuhwak, SD Pam. Abstract. No Abstract. Nigerian Journal of Medicine Vol. 16 (2) 2007: pp.156-160. Full Text: EMAIL FULL TEXT EMAIL FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT. Article Metrics. Metrics ...
Full Text Available The gap between best practice and actual patient care continues to be a pervasive problem in our healthcare system. Efforts to improve on this knowledge_performance gap have included computerised disease management programs designed to improve guideline adherence. However, current computerised reminder and decision support interventions directed at changing physician behaviour have had only a limited and variable effect on clinical outcomes. Further, immediate pay-for-performance financial pressures on institutions have created an environmentwhere disease management systems are often created under duress, appended to existing clinical systems and poorly integrated into the existing workflow, potentially limiting their realworld effectiveness. The authors present a review of disease management as well as a conceptual framework to guide the development of more effective health information technology (HIT tools for translating clinical information into clinical action.
Jensen, Tina Blegind; Kjærgaard, Annemette Leonhardt
The implementation of information systems (IS) in organizations often triggers new situations in which users experience a disruption of existing work patterns and routines. Sensemaking becomes central in making users’ meanings explicit, serving as a foundation for further actions and interactions...... with the new technology. The purpose of this paper is to study how users make sense of new technologies by building on existing response repertoires. Empirically, we present findings from a study of an Electronic Patient Record (EPR) system implementation in two Danish hospital wards. Our findings illustrate...... to existing literature by providing a detailed account of how users’ early sensemaking of a technology influences their subsequent actions and reactions towards it. Our findings support managers in understanding users’ perceptions of a new technology, helping them in planning and executing the implementation...
Most differences, shortcomings and contradictions regarding voluntary informed consent for participation in clinical research relate to the South African-specific guidance documents, i.e. South African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa (2006) and Ethics in ...
Full Text Available Abstract Background Decisions concerning drug safety and efficacy are generally based on pivotal evidence provided by clinical trials. Unfortunately, finding the relevant clinical trials is difficult and their results are only available in text-based reports. Systematic reviews aim to provide a comprehensive overview of the evidence in a specific area, but may not provide the data required for decision making. Methods We review and analyze the existing information systems and standards for aggregate level clinical trials information from the perspective of systematic review and evidence-based decision making. Results The technology currently used has major shortcomings, which cause deficiencies in the transfer, traceability and availability of clinical trials information. Specifically, data available to decision makers is insufficiently structured, and consequently the decisions cannot be properly traced back to the underlying evidence. Regulatory submission, trial publication, trial registration, and systematic review produce unstructured datasets that are insufficient for supporting evidence-based decision making. Conclusions The current situation is a hindrance to policy decision makers as it prevents fully transparent decision making and the development of more advanced decision support systems. Addressing the identified deficiencies would enable more efficient, informed, and transparent evidence-based medical decision making.
Informed consent is the core aspect of the patient-physician relationship. Since its beginnings, clinical bioethics was opposed to the authoritarian paternalism characteristic of medicine since the 19th century. The informed consent was developed to provide patients with sufficient information to allow autonomous decisions when faced with medical diagnostic and therapeutic alternatives. In spite of bioethics effort to perfect informed consent, the discipline has been unable to avoid informed consent from becoming an impersonal and administrative procedure. Even though the major goal of this procedure is to provide sufficient information to allow patients an objective weighting of benefits and risks of medical practice, the uncertainties of medicine make full disclosure unattainable. Collecting more information finally leads to indecision and ultimate trust in medical advice. The clinical encounter is fundamentally a fiduciary relationship, and bioethics ought to accept that its main objective is to strengthen the trust bond that is essential to the clinical encounter. This goal may become incompatible with the quest for unlimited autonomy. Patients often will only require information as long as they distrust that medical institutions and their professionals are considering their interests and needs. The main proposal of this article is to temper bioethics insistence on autonomy, and accept that patients essentially seek to be protected and cared for. Informed consent ought to relent its efforts at full autonomy to the benefit of trustworthiness in medicine, and trust in clinical practice.
Full Text Available The aim of the paper is to present the role of a military leader in engaging the challenges and threats existing in the I nformation Environment (IE. Military leadership is crucial for the functioning of a particular form of hierarchical institution, namely the armed forces, in their external surrounding called O perational Environment (OE. A specific type of O E is I nformation Environment (IE characterized by the three dimensions: physical, informational and cognitive. Moreover, its characteristics include the occurrence of a number of challenges and threats. The most important challenges include: overabundance of information, unstructured information, problematic value of information and low information-related competences of its users. I n turn, the most important of the threats identified in the I E are disinformation and propaganda. The role of an effective leader is to prevent, and if it is impossible, to alleviate the consequences of the challenges and threats that may disrupt or even prevent the achievement of the objectives set by an organisation.
Johnston, Megan E; Treharne, Gareth J; Chapman, Peter T; Stamp, Lisa K
Inadequate patient information about gout may contribute to poor disease outcomes. We reviewed existing educational resources for gout to identify strengths and weaknesses and compare resources cross-nationally. Content, readability, and dietary recommendations were reviewed using a sample of 30 resources (print and Web-based) from 6 countries. More than half of the resources were written at a highly complex level. Some content areas were lacking coverage, including comorbidity risks, uric acid target levels, and continuing allopurinol during acute attacks. Our findings suggest significant room for improvement in gout patient educational resources, particularly regarding self-management.
Caon, Martin [School of Nursing and Midwifery, Flinders University, Adelaide (Australia)], E-mail: email@example.com
Examples of the statements about the radiation from medical imaging in the information for participants provided to the Human Research Ethics Committee (HREC) for approval are presented and discussed. There is considerable scope for improvement in the information about radiation that is presented to potential participants in clinical trials. Many radiation statements seem only intended to allay fear and anxiety about radiation rather than providing accurate information. This situation cannot be said to be conducive to allowing the participant to give informed consent to their involvement in a clinical trial in which ionising radiation is used. As many clinical trials are international and conducted at many sites (sometimes over 100), we would expect the same statements to have been seen by members of HRECs in many countries. Few HRECs include a member who is an expert in radiation. Hence, to ensure that the information is sound, those sections of the participant information that refer to radiation should be written or reviewed by a specialist in radiation protection such as a medical physicist, a health physicist or a radiation safety officer. (opinion)
Full Text Available Vectors based on adeno-associated viruses have shown considerable promise in both preclinical models and increasingly in clinical trials. However, one formidable challenge is pre-existing immunity due to widespread exposure to numerous AAV variants and serotypes within the human population, which affect efficacy of clinical trials due to the accompanying high levels of anti-capsid neutralizing antibodies. Transient immunosuppression has promise in mitigating cellular and humoral responses induced by vector application in naïve hosts, but cannot overcome the problem that pre-existing neutralizing antibodies pose towards the goal of safe and efficient gene delivery. Shielding of AAV from antibodies, however, may be possible by covalent attachment of polymers to the viral capsid or by encapsulation of vectors inside biomaterials. In addition, there has been considerable progress in using rational mutagenesis, combinatorial libraries, and directed evolution approaches to engineer capsid variants that are not recognized by anti-AAV antibodies generally present in the human population. While additional progress must be made, such strategies, alone or in combination with immunosuppression to avoid de novo induction of antibodies, have strong potential to significantly enhance the clinical efficacy of AAV vectors.
Khalifa, Abdulrahman; Meystre, Stéphane
The 2014 i2b2 natural language processing shared task focused on identifying cardiovascular risk factors such as high blood pressure, high cholesterol levels, obesity and smoking status among other factors found in health records of diabetic patients. In addition, the task involved detecting medications, and time information associated with the extracted data. This paper presents the development and evaluation of a natural language processing (NLP) application conceived for this i2b2 shared task. For increased efficiency, the application main components were adapted from two existing NLP tools implemented in the Apache UIMA framework: Textractor (for dictionary-based lookup) and cTAKES (for preprocessing and smoking status detection). The application achieved a final (micro-averaged) F1-measure of 87.5% on the final evaluation test set. Our attempt was mostly based on existing tools adapted with minimal changes and allowed for satisfying performance with limited development efforts. Copyright © 2015 Elsevier Inc. All rights reserved.
Utilizing Existing Clinical and Population Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection, a 2013 workshop sponsored by the Epidemiology and Genomics Research Program.
Moreno-Conde, Alberto; Austin, Tony; Moreno-Conde, Jesús; Parra-Calderón, Carlos L; Kalra, Dipak
Clinical information models are formal specifications for representing the structure and semantics of the clinical content within electronic health record systems. This research aims to define, test, and validate evaluation metrics for software tools designed to support the processes associated with the definition, management, and implementation of these models. The proposed framework builds on previous research that focused on obtaining agreement on the essential requirements in this area. A set of 50 conformance criteria were defined based on the 20 functional requirements agreed by that consensus and applied to evaluate the currently available tools. Of the 11 initiative developing tools for clinical information modeling identified, 9 were evaluated according to their performance on the evaluation metrics. Results show that functionalities related to management of data types, specifications, metadata, and terminology or ontology bindings have a good level of adoption. Improvements can be made in other areas focused on information modeling and associated processes. Other criteria related to displaying semantic relationships between concepts and communication with terminology servers had low levels of adoption. The proposed evaluation metrics were successfully tested and validated against a representative sample of existing tools. The results identify the need to improve tool support for information modeling and software development processes, especially in those areas related to governance, clinician involvement, and optimizing the technical validation of testing processes. This research confirmed the potential of these evaluation metrics to support decision makers in identifying the most appropriate tool for their organization. Los Modelos de Información Clínica son especificaciones para representar la estructura y características semánticas del contenido clínico en los sistemas de Historia Clínica Electrónica. Esta investigación define, prueba y valida
Ji Min Choi
Full Text Available Although gastric adenoma is widely accepted as a precursor of gastric cancer, pre-existing adenoma is not always detected in gastric cancer patients.To investigate the clinical characteristics of early gastric cancer (EGC arising from adenoma, compared with those of EGC without pre-existing adenoma.Patients who underwent endoscopic resection for EGC at a single tertiary hospital were divided into two groups based on the presence (ex-adenoma group or absence (de novo group of pre-existing adenoma on pathologic specimens. Clinicopathologic characteristics, endoscopic features and long-term outcomes were analyzed.Of 1,509 patients, 236 (15.6% were included in the ex-adenoma group. Mean age (P = 0.003 and Helicobacter pylori infection rate (P = 0.040 were significantly higher in the ex-adenoma than in the de novo group. Mean endoscopic size was significantly larger, elevated lesions were more prevalent (both P < 0.001, and carcinomas were more differentiated in the ex-adenoma group than in the de novo group (P = 0.037. The degree of atrophy (P = 0.025 or intestinal metaplasia (P < 0.001 was more advanced in the ex-adenoma group. Synchronous gastric neoplasia was significantly more prevalent in the ex-adenoma group (P < 0.001, whereas metachronous cancer recurrence rate was not significantly different between the two groups.EGCs with pre-existing adenoma show a greater association with H. pylori-related chronic inflammation than those without, which could explain the differences in the characteristics between groups. Potential differences in carcinogenic mechanisms between the groups were explored.
Glen P. Martin
Full Text Available Abstract Background Clinical prediction models (CPMs are increasingly deployed to support healthcare decisions but they are derived inconsistently, in part due to limited data. An emerging alternative is to aggregate existing CPMs developed for similar settings and outcomes. This simulation study aimed to investigate the impact of between-population-heterogeneity and sample size on aggregating existing CPMs in a defined population, compared with developing a model de novo. Methods Simulations were designed to mimic a scenario in which multiple CPMs for a binary outcome had been derived in distinct, heterogeneous populations, with potentially different predictors available in each. We then generated a new ‘local’ population and compared the performance of CPMs developed for this population by aggregation, using stacked regression, principal component analysis or partial least squares, with redevelopment from scratch using backwards selection and penalised regression. Results While redevelopment approaches resulted in models that were miscalibrated for local datasets of less than 500 observations, model aggregation methods were well calibrated across all simulation scenarios. When the size of local data was less than 1000 observations and between-population-heterogeneity was small, aggregating existing CPMs gave better discrimination and had the lowest mean square error in the predicted risks compared with deriving a new model. Conversely, given greater than 1000 observations and significant between-population-heterogeneity, then redevelopment outperformed the aggregation approaches. In all other scenarios, both aggregation and de novo derivation resulted in similar predictive performance. Conclusion This study demonstrates a pragmatic approach to contextualising CPMs to defined populations. When aiming to develop models in defined populations, modellers should consider existing CPMs, with aggregation approaches being a suitable modelling
Walston, Leroy J. [Argonne National Lab. (ANL), Argonne, IL (United States); Rollins, Katherine E. [Argonne National Lab. (ANL), Argonne, IL (United States); Smith, Karen P. [Argonne National Lab. (ANL), Argonne, IL (United States); LaGory, Kirk E. [Argonne National Lab. (ANL), Argonne, IL (United States); Sinclair, Karin [National Renewable Energy Lab. (NREL), Golden, CO (United States); Turchi, Craig [National Renewable Energy Lab. (NREL), Golden, CO (United States); Wendelin, Tim [National Renewable Energy Lab. (NREL), Golden, CO (United States); Souder, Heidi [National Renewable Energy Lab. (NREL), Golden, CO (United States)
There are two basic types of solar energy technology: photovoltaic and concentrating solar power. As the number of utility-scale solar energy facilities using these technologies is expected to increase in the United States, so are the potential impacts on wildlife and their habitats. Recent attention is on the risk of fatality to birds. Understanding the current rates of avian mortality and existing monitoring requirements is an important first step in developing science-based mitigation and minimization protocols. The resulting information also allows a comparison of the avian mortality rates of utility-scale solar energy facilities with those from other technologies and sources, as well as the identification of data gaps and research needs. This report will present and discuss the current state of knowledge regarding avian issues at utility-scale solar energy facilities.
Weisrock David W
Full Text Available Abstract Salamanders of the genus Ambystoma are a unique model organism system because they enable natural history and biomedical research in the laboratory or field. We developed Sal-Site to integrate new and existing ambystomatid salamander research resources in support of this model system. Sal-Site hosts six important resources: 1 Salamander Genome Project: an information-based web-site describing progress in genome resource development, 2 Ambystoma EST Database: a database of manually edited and analyzed contigs assembled from ESTs that were collected from A. tigrinum tigrinum and A. mexicanum, 3 Ambystoma Gene Collection: a database containing full-length protein-coding sequences, 4 Ambystoma Map and Marker Collection: an image and database resource that shows the location of mapped markers on linkage groups, provides information about markers, and provides integrating links to Ambystoma EST Database and Ambystoma Gene Collection databases, 5 Ambystoma Genetic Stock Center: a website and collection of databases that describe an NSF funded salamander rearing facility that generates and distributes biological materials to researchers and educators throughout the world, and 6 Ambystoma Research Coordination Network: a web-site detailing current research projects and activities involving an international group of researchers. Sal-Site is accessible at http://www.ambystoma.org.
Hill, V.; Bruner, K.; Maciaz, G.; Saucedo, L.; Catzoela, L.; Ramirez, R.; Jacobs, W.J.; Nguyen, P.; Patel, L.; Webster, S.L.
Summary Objectives To identify and describe the most critical strategic and operational contributors to the successful implementation of clinical information technologies, as deployed within a moderate sized system of U.S. community hospitals. Background and Setting CHRISTUS Health is a multi-state system comprised of more than 350 services and 60 hospitals with over 9 000 physicians. The Santa Rosa region of CHRISTUS Health, located in greater San Antonio, Texas is comprised of three adult community hospital facilities and one Children’s hospital each with bed capacities of 142–180. Computerized Patient Order Entry (CPOE) was first implemented in 2012 within a complex market environment. The Santa Rosa region has 2 417 credentialed physicians and 263 mid-level allied health professionals. Methods This report focuses on the seven most valuable strategies deployed by the Health Informatics team in a large four hospital CHRISTUS region to achieve strong CPOE adoption and critical success lessons learned. The findings are placed within the context of the literature describing best practices in health information technology implementation. Results While the elements described involved discrete de novo process generation to support implementation and operations, collectively they represent the creation of a new customer-centric service culture in our Health Informatics team, which has served as a foundation for ensuring strong clinical information technology adoption beyond CPOE. Conclusion The seven success factors described are not limited in their value to and impact on CPOE adoption, but generalize to – and can advance success in – varied other clinical information technology implementations across diverse hospitals. A number of these factors are supported by reports in the literature of other institutions’ successful implementations of CPOE and other clinical information technologies, and while not prescriptive to other settings, may be adapted to yield
... Clinical Trials: Information and Options for People with Mood Disorders What are clinical trials? Clinical trials are research ... during a clinical trial? Clinical trials that test mood disorder treatments are usually conducted on an outpatient basis, ...
Anderson, D.R.; Burnham, K.P.; White, Gary C.
Conflicts often arise in the management of natural resources. Often they result from differing perceptions, varying interpretations of the law, and self-interests among stakeholder groups (for example, the values and perceptions about spotted owls and forest management differ markedly among environmental groups, government regulatory agencies, and timber industries). We extend the conceptual approach to conflict resolution of Anderson et al. (1999) by using information-theoretic methods to provide quantitative evidence for differing stakeholder positions. Importantly, we assume that relevant empirical data exist that are central to the potential resolution of the conflict. We present a hypothetical example involving an experiment to assess potential effects of a chemical on monthly survival probabilities of the hen clam (Spisula solidissima). The conflict centers on 3 stakeholder positions: 1) no effect, 2) an acute effect, and 3) an acute and chronic effect of the chemical treatment. Such data were given to 18 analytical teams to make independent analyses and provide the relative evidence for each of 3 stakeholder positions in the conflict. The empirical evidence strongly supports only one of the 3 positions in the conflict: the application of the chemical causes acute and chronic effects on monthly survival, following treatment. Formal inference from all the stakeholder positions is provided for the 2 key parameters underlying the hen clam controversy. The estimates of these parameters were essentially unbiased (the relative bias for the control and treatment group's survival probability was -0.857% and 1.400%, respectively) and precise (coefficients of variation were 0.576% and 2.761%, respectively). The advantages of making formal inference from all the models, rather than drawing conclusions from only the estimated best model, is illustrated. Finally, we contrast information-theoretic and Bayesian approaches in terms of how positions in the controversy enter
Freundlich, Robert E; Ehrenfeld, Jesse M
Perioperative informatics tools continue to be developed at a rapid pace and offer clinicians the potential to greatly enhance clinical decision making. The goal of this review is to bring the reader updates on perioperative information management and discuss future research directions in the field. Clinical decision support tools become more timely, accurate, and, in some instances, have been shown to improve patient outcomes. When correctly implemented, they are critical tools for optimization of perioperative care. Perioperative informaticians continue to test new and innovative ways to enhance the delivery of anesthesia care, improving the safety and efficacy of perioperative management. Future work will continue to refine tools to ensure that perioperative informatics provides clinicians timely and accurate feedback, with demonstrable evidence that a decision support system improves patient outcomes.
Xie, Feng; Chen, Guo-Xiang; Jiang, Zhan-Tao
This article describes how to construct a integrated wireless clinical information system based on the original information system. It is constructed on the basis of the hospital HIS through the middle ware which provides a data-interaction platform for all the existing data and the data which would be added in future for various information management systems. The software system adopts the Web Service technology in information services. The SOAP protocol is applied to the data interaction between the foreground and the background. The mode of the network structure is "Wireless Switchboard + Intelligence antenna". Relying on the wireless network, the handheld data terminal and the barcode, the network information can be extended to the patient bedsides and the mobile medical personnels.
... information already in AVS is accurate and complete may certify to us by swearing or affirming, under oath and... corrections and swear or affirm, under oath and in writing, that the information you submit is accurate and... swear or affirm, under oath and in writing, that all information you provide in an application is...
Weisskopf, Michael; Bucklar, Guido; Blaser, Jürg
Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient-trial-assignment-tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of
Full Text Available Hilde Jensvoll,1,2 Marianne T Severinsen,3,4 Jens Hammerstrøm,5 Sigrid K Brækkan,1,2 Søren R Kristensen,4,6 Suzanne C Cannegieter,7 Kristine Blix,1,2 Anne Tjønneland,8 Frits R Rosendaal,1,7,9 Olga Dziewiecka,1 Kim Overvad,10,11 Inger Anne Næss,12 John-Bjarne Hansen1,21Department of Clinical Medicine, KG Jebsen – Thrombosis Research and Expertise Center (TREC, UiT – The Arctic University of Norway, 2Division of Internal Medicine, University Hospital of North Norway, Tromsø, Norway; 3Department of Hematology, Aalborg University Hospital, 4Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; 5Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; 6Department of Clinical Biochemistry, Aalborg University Hospital, Aalborg, Denmark; 7Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands; 8Diet, Genes and Environment, Danish Cancer Society Research Center, Copenhagen, Denmark; 9Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands; 10Department of Cardiology, Aalborg University Hospital, Aalborg, 11Department of Public Health, Section for Epidemiology, Aarhus University, Aarhus, Denmark; 12Department of Hematology, Trondheim University Hospital, Trondheim, NorwayBackground: Although venous thromboembolism (VTE is a known common complication in cancer patients, there is limited knowledge on patient-related and cancer-specific risk factors in the general population. The Scandinavian Thrombosis and Cancer (STAC Cohort was established by merging individual data from three large Scandinavian cohorts (The Tromsø Study, the second Nord-Trøndelag Health Study, and the Danish Diet, Cancer and Health Study. Here, we present the profile of the STAC cohort and provide age-specific incidence rates of VTE and cancerMethods: The STAC cohort includes 144,952 subjects aged 19–101 years
Mogg, Karin; Bradbury, Katherine E; Bradley, Brendan P
The present study used two cognitive tasks--a text comprehension task and a homophone task--to investigate whether clinically depressed individuals have a negative bias when interpreting ambiguous information. Previous research indicates that both tasks are sensitive to anxiety-related interpretive biases, and that the former is less prone to response bias effects. Negative memory biases were also assessed. Results showed that, compared with normal controls, depressed individuals made more negative interpretations on the homophone task, and they also showed an enhanced negative recall bias. However, the groups did not differ in interpretative bias on the text comprehension task. Possible explanations of the results are discussed, including the potential influences of self-referent processing and response bias.
... information is required with each escape and evacuation plan submission: (1) Mine maps or diagrams showing...) A statement of the availability of emergency communication and transportation facilities, emergency...
Lerner, Matthew D; De Los Reyes, Andres; Drabick, Deborah A G; Gerber, Alan H; Gadow, Kenneth D
Discrepancy between informants (parents and teachers) in severity ratings of core symptoms commonly arise when assessing autism spectrum disorder (ASD). Whether such discrepancy yields unique information about the ASD phenotype and its clinical correlates has not been examined. We examined whether degree of discrepancy between parent and teacher ASD symptom ratings defines discrete, clinically meaningful subgroups of youth with ASD using an efficient, cost-effective procedure. Children with ASD (N = 283; 82% boys; M age = 10.5 years) were drawn from a specialty ASD clinic. Parents and teachers provided ratings of the three core DSM-IV-TR domains of ASD symptoms (communication, social, and perseverative behavior) with the Child and Adolescent Symptom Inventory-4R (CASI-4R). External validators included child psychotropic medication status, frequency of ASD-relevant school-based services, and the Autism Diagnostic Observation Schedule (ADOS-2). Four distinct subgroups emerged that ranged from large between-informant discrepancy (informant-specific) to relative lack of discrepancy (i.e. informant agreement; cross-situational): Moderate Parent/Low Teacher or Low Parent/Moderate Teacher Severity (Discrepancy), and Moderate or High Symptom Severity (Agreement). Subgroups were highly distinct (mean probability of group assignment = 94%). Relative to Discrepancy subgroups, Agreement subgroups were more likely to receive psychotropic medication, school-based special education services, and an ADOS-2 diagnosis. These differential associations would not have been identified based solely on CASI-4R scores from one informant. The degree of parent-teacher discrepancy about ASD symptom severity appears to provide more clinically useful information than reliance on a specific symptom domain or informant, and thus yields an innovative, cost-effective approach to assessing functional impairment. This conclusion stands in contrast to existing symptom clustering approaches in
...; Extension and Revision of Existing Collection; Annual Parole Survey, Annual Probation Survey, and Annual... Corrections or state probation and parole authority. Others: The Federal Bureau of Prisons, city and county... probation; (k) Whether the probation authority supervised adult probationers who were also on parole...
Full Text Available blanket solutions. Many agents act on an environment at any given time and decision makers need to engage with that complexity. Enterprises emerging from informal settlements or through informal processes may be better suited to low-income groups, thus...
... 21st floor. FOR FURTHER INFORMATION CONTACT: Mario Distasio, Chief of the Economic Analysis Division... readings of 0.1 WL to 0.3 WL and every 3 months in non-uranium underground mines where the readings are 0.1..., mechanical, or other technological collection techniques or other forms of information technology, e.g...
... 21st floor. FOR FURTHER INFORMATION CONTACT: Mario Distasio, Chief of the Economic Analysis Division... readings of 0.1 WL to 0.3 WL and every 3 months in non-uranium underground mines where the readings are 0.1..., mechanical, or other technological collection techniques or other forms of information technology, e.g...
... confidential. EEO-4 data are used by the EEOC to investigate charges of discrimination against State and local governments and to provide information on the employment status of minorities and women. The data are shared...
... confidential. EEO-1 data is used by EEOC to investigate charges of employment discrimination against employers in private industry and to provide information about the employment status of minorities and women...
... confidential. EEO-1 data is used by EEOC to investigate charges of employment discrimination against employers in private industry and to provide information about the employment status of minorities and women...
... discrimination against State and local governments and to provide information on the employment status of minorities and women. The data are shared with several other Federal agencies. Pursuant to section 709(d) of...
... discrimination against employers in private industry and to provide information about the employment status of minorities and women. The data is shared with the Office of Federal Contract Compliance Programs (OFCCP), U.S...
... confidential. EEO-1 data is used by EEOC to investigate charges of employment discrimination against employers in private industry and to provide information about the employment status of minorities and women...
... charges of discrimination against State and local governments and to provide information on the employment status of minorities and women. The data are shared with several other federal agencies. Pursuant to...
... geological area in which the mine is located). At present, this applies only to underground oil shale mines... enhance the quality, utility, and clarity of the information to be collected; and Address the use of...
... Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L... technological collection techniques or other forms of information technology, e.g., permitting electronic...
... Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L... technological collection techniques or other forms of information technology, e.g., permitting electronic...
... Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L... technological collection techniques or other forms of information technology, e.g., permitting electronic...
de Boer, G.J.; Baart, F.; Jagers, B; Becker, B.P.J.; Piasecki, M.
Assessment of environmental status and integral safety requires combination of information from many sources, coming from either databases or increasingly via live model (scenario) simulations. Many of these models require input from one another, sometimes unidirectional, but more and more
National Oceanic and Atmospheric Administration, Department of Commerce — The ACFHP database consist of three primary data tables, joined within SQL Server, a relational DBMS: 1. The Bibliographic table provides information on over 500...
Lepola, Pirkko; Needham, Allison; Mendum, Jo; Sallabank, Peter; Neubauer, David; de Wildt, Saskia
Paediatric clinical trials are often conducted as multinational trials. Informed consent or assent is part of the ethics committee approval for clinical trials. The consent requirements vary between countries due to national laws and regulations, which are not harmonised in Europe. These discrepancies can present challenges for paediatric clinical trials. The aim of this study was to assemble these consent and assent requirements across the European Economic Area. The collated national requirements have not been publicly available before, despite a real need for this data. National consent and assent requirements for paediatric clinical trials were analysed and collated for 25 European Union Member States and 2 European Free Trade Association countries until the end of 2014. The data were retrieved from existing databases and through communication with the competent authorities and selected ethics committees. Results from a literature search for international or national guidelines, declarations and conventions and academic societies' publications served as comparison material. Consent and assent requirements are heterogeneous across these countries. We compiled our findings in 'The Informed Consent and Assent Tool Kit', a table including 27 national consent and assent requirements listed by individual country. Wide variation in paediatric consents and assents presents challenges for multinational paediatric trials in Europe. The toolkit is available for all those involved in paediatric clinical trials and ethics committees, providing a new platform for proactive feedback on informed consent requirements, and may finally lead to a needed harmonisation process, including uniform standards accepted across Europe. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Full Text Available In light of the European refugee situation, we investigate how information about others’ support influences individuals’ willingness to help. When individuals see information about other people supporting refugees, they may either be influenced by a descriptive norm, and act accordingly. Alternatively, they may perceive that others are already doing the job, and thus engage in social loafing. In an experiment (N = 132, we tested these competing predictions. Specifically, participants were exposed to a map of Germany that either indicated many or few helping initiatives across the country. In a control group, no map was shown. Subsequently, participants were asked about their willingness to help. While there was no effect between the two map conditions, results revealed that participants reported lower willingness to help in both map conditions, compared with the control group. Thus, providing information about helping projects results in social loafing, jeopardizing widespread communication strategies to increase solidarity.
... or safety standards for the protection of life and prevention of injuries in coal or other mines... FOR FURTHER INFORMATION CONTACT section of this notice, or viewed on the Internet by selecting ``Rules.... Agency: Mine Safety and Health Administration. OMB Number: 1219-0143. Frequency: On Occasion. Affected...
... gases can be expected to infiltrate the work environment at any time. The working environment is... environment for the slope and shaft sinking employees. The record is maintained at the mine site for the... technological collection techniques or other forms of information technology (e.g., permitting electronic...
... who use them in making decisions during accident investigations to establish root causes and to... methods: (1) Electronic mail: [email protected] . (2) Facsimile: 202-693-9441. (3) Regular Mail... collection and the collection of this information does not employ statistical methods. ] Type of Review...
... movements of adult offenders through state correctional systems, as well as to examine long term trends in... information is required contact: Jerri Murray, Department Clearance Officer, United States Department of... NE., Washington, DC 20530. Jerri Murray, Department Clearance Officer, PRA, U.S. Department of...
... integral part of the justice system, operating at the front end (that is, following arrest or referral) as well as the back end (discharging inmates and holding those sentenced to jail). Their broad functions..., mechanical, or other technological collection techniques or other forms of information technology, e.g...
... justice system, operating at the front end (that is, following arrest or referral) as well as the back end..., mechanical, or other technological collection techniques or other forms of information technology, e.g... appearances and bringing them back to detention, discharging inmates at the behest of the court or other...
... justice system, operating at the front end (that is, following arrest or referral) as well as the back end..., mechanical, or other technological collection techniques or other forms of information technology, e.g... appearances and bringing them back to detention, discharging inmates at the behest of the court or other...
... techniques or other forms of information technology, e.g., permitting electronic submission of responses... reading the directions for the Federal Bureau of Investigation National Instant Criminal Background Check... two minutes to read which would be 3,000 x 2 minutes/60 = 100 hours. The entire process of reading the...
... collection techniques or other forms of information technology, e.g., permitting electronic submission of... to read which would be 3,000 x 2 minutes/60 = 100 hours. The entire process of reading the letter and... and reading the accompanying letter would be 3,000 x 15/60 = 750 hours. (5) An estimate of the total...
... collection techniques or other forms of information technology, e.g., permitting electronic submission of... to read which would be 3,000 x 2 minutes/60 = 100 hours. The entire process of reading the letter and... and reading the accompanying letter would be 3,000 x 15/60 = 750 hours. (5) An estimate of the total...
...; Medical, mental health, and substance abuse treatment services issues in jails; Suicide prevention, domestic violence counseling, sex offender treatment, educational programs, and inmate work assignments... from the largest county and city jails. Information on mental and medical health and substance abuse...
...-- Reinstatement, Comments Requested: Friction Ridge Cards: Arrest and Institution; Applicant; Personal...) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden... form/collection: Friction Ridge Cards: Arrest and Institution; Applicant; Personal Identification; FBI...
Ford, James H; Turner, Alexis; Yoshii, Adriana
The integration of bioinformatics and clinical informatics requires the assimilation of genomic information into the clinical record, as well as an understanding of the information needs of genomics researchers. This paper focuses on a methodology to make this information requirements determination and capture an initial set of requirements for future information systems development.
Companies and organizations world-wide depend more and more on IT infrastructure and operations. Computer systems store vital information and sensitive data; computing services are essential for main business processes. This high dependency comes with a number of security risks, which have to be managed correctly on technological, organizational and human levels. Addressing the human aspects of information security often boils down just to procedures, training and awareness raising. On the other hand, employees and collaborators do not adopt security attitude and habits simply when told to do so – a real change in behaviour requires an established security culture. But how to introduce a security culture? This thesis outlines the need of developing or improving security culture, and discusses how this can be done. The proposed approach is to gradually build security knowledge and awareness, and influence behaviours. The way to achieve this is to make security communication pervasive by embedding security me...
Wighton, Paul; Lee, Tim K.; McLean, David; Lui, Harvey; Atkins, M. Stella
Texture is known to predict atypicality in pigmented skin lesions. This paper describes an experiment that was conducted to determine 1) if this textural information is present in the center of skin lesions, and 2) how color affects the perception of this information. Images of pigmented skin lesions from three categories were shown to subjects in such a way that only textural information could be perceived; other factors known to predict atypicality were removed or held constant. These images were shown in both color and grayscale. Each subject assigned a score of atypicality to each image. The experiment was conducted on 5 subjects of varying backgrounds, including one expert. Each subject's accuracy under each modality was measured by calculating the volume under a 3-way ROC surface. The modalities were compared using the Dorfman-Berbaum-Metz (DBM) method of ROC analysis, giving a p-value of 0.8611. Therefore the null hypothesis that there is no difference between the predictive power of the modalities cannot be rejected. Also, a two one-sided test of equivalence (TOST) was performed giving a p-value pair of pigmented skin lesions.
Liu, Zhi-shun; Cai, Yu-ying
The modernization and internationalization of acupuncture and moxibustion is inevitable trends to develop acupuncture and moxibustion. However, the acupuncture research findings in China are not accepted by the mainstream medicine abroad. The major problems are that the study purposes are not specific and the modern scientific research methods are not rationally used in acupuncture clinical study. Two major issues in acupuncture clinical study in China are the evaluation of the specificity of acupuncture and the overall effect of acupuncture treatment. The core and basis of acupuncture clinical study are the clarity of study purpose, following the law of evidence-based medicine and rational selection of modern scientific methods. On the basis of the characteristics of acupuncture and the specialty of acupuncture clinical study, for instance, the types of trial design, blind methods, the selection of control group and outcome assessment system, the objective of this paper provides research strategies for researchers and to improve the overall level of research in the acupuncture clinical study.
Li, Xinmin; Quigg, Richard J; Zhou, Jian; Gu, Weikuan; Nagesh Rao, P; Reed, Elaine F
Microarray-based clinical tests have become powerful tools in the diagnosis and treatment of diseases. In contrast to traditional DNA-based tests that largely focus on single genes associated with rare conditions, microarray-based tests are ideal for the study of diseases with underlying complex genetic causes. Several microarray based tests have been translated into clinical practice such as MammaPrint and AmpliChip CYP450. Additional cancer-related microarray-based tests are either in the process of FDA review or under active development, including Tissue of Tumor Origin and AmpliChip p53. All diagnostic microarray testing is ordered by physicians and tested by a Clinical Laboratories Improvement Amendment-certified (CLIA) reference laboratory. Recently, companies offering consumer based microarray testing have emerged. Individuals can order tests online and service providers deliver the results directly to the clients via a password-protected secure website. Navigenics, 23andMe and deCODE Genetics represent pioneering companies in this field. Although the progress of these microarray-based tests is extremely encouraging with the potential to revolutionize the recognition and treatment of common diseases, these tests are still in their infancy and face technical, clinical and marketing challenges. In this article, we review microarray-based tests which are currently approved or under review by the FDA, as well as the consumer-based testing. We also provide a summary of the challenges and strategic solutions in the development and clinical use of the microarray-based tests. Finally, we present a brief outlook for the future of microarray-based clinical applications.
Pryszcz, Leszek P; Németh, Tibor; Gácser, Attila; Gabaldón, Toni
The Candida parapsilosis species complex comprises a group of emerging human pathogens of varying virulence. This complex was recently subdivided into three different species: C. parapsilosis sensu stricto, C. metapsilosis, and C. orthopsilosis. Within the latter, at least two clearly distinct subspecies seem to be present among clinical isolates (Type 1 and Type 2). To gain insight into the genomic differences between these subspecies, we undertook the sequencing of a clinical isolate classified as Type 1 and compared it with the available sequence of a Type 2 clinical strain. Unexpectedly, the analysis of the newly sequenced strain revealed a highly heterozygous genome, which we show to be the consequence of a hybridization event between both identified subspecies. This implicitly suggests that C. orthopsilosis is able to mate, a so-far unanswered question. The resulting hybrid shows a chimeric genome that maintains a similar gene dosage from both parental lineages and displays ongoing loss of heterozygosity. Several of the differences found between the gene content in both strains relate to virulent-related families, with the hybrid strain presenting a higher copy number of genes coding for efflux pumps or secreted lipases. Remarkably, two clinical strains isolated from distant geographical locations (Texas and Singapore) are descendants of the same hybrid line, raising the intriguing possibility of a relationship between the hybridization event and the global spread of a virulent clone.
Codriansky, Andres; Hong, Jiaxu; Xu, Jianjian; Deng, Sophie X.
Purpose To report the presence of normal limbal epithelium detected by in vivo confocal laser scanning microscopy (IVCM) in three cases of clinically diagnosed total limbal stem cell deficiency (LSCD). Methods This is a retrospective case report consists of three patients who were diagnosed with total LSCD based on clinical exam and/or impression cytology. Clinical data including ocular history, presentation, slit-lamp examination, IVCM and impression cytology were reviewed. Results The etiology was chemical burn in three cases. One patient has two failed penetrating keratoplasty. Another had allogeneic keratolimbal transplantation but the graft failed one year after surgery. The third patient had failed amniotic membrane transplantation. These three patients presented with signs of total LSCD including the absence of normal Vogt palisades, complete superficial vascularization of the peripheral cornea, non-healing epithelial defects, and corneal scarring. Impression cytology was performed in two cases to confirm the presence of goblet cells in two cases. Each patient however still had distinct areas of corneal and/or limbal epithelial cells detected by IVCM. Conclusions Residual normal limbal epithelial cells could be present in eyes with clinical features of total LSCD. IVCM appears to be a more accurate method to evaluate the degree of LSCD. PMID:27362882
Mandrin, P. A.
It is shown that a quantum gravity formulation exists on the basis of quantum number conservation, the laws of thermodynamics, unspecific interactions, and locally maximizing the ratio of resulting degrees of freedom per imposed degree of freedom of the theory. The First Law of thermodynamics is evaluated by imposing boundary conditions to the theory. These boundary conditions determine the details of the complex world structure. No explicite microscopic quantum structure is required, and thus no ambiguity arises on how to construct the model. Although no dynamical computations of quantum systems are possible on this basis, all well established physics may be recovered, and all measurable quantities may be computed. The recovery of physical laws is shown by extremizing the entropy, which means varying the action on the bulk and boundary of small volumes of curved space-time. It is sketched how Quantum Field Theory (QFT) and General Relativity (GR) are recovered with no further assumptions except for imposing the dimension of a second derivative of the metric on the gravitational field equations. The new concepts are 1. the abstract organization of statistical quantum states, allowing for the possibility of absent quantum microstructure, 2. the optimization of the locally resulting degrees of freedom per imposed degree of freedom of the theory, allowing for the reconstruction of the spacetime dimensions, 3. the reconstruction of physical and geometric quantities by means of stringent mathematical or physical justifications, 4. the fully general recovery of GR by quasi-local variation methods applied on small portions of spacetime.
Haala, Norbert; Anders, Karl-Heinrich
For a task like 3D building reconstruction, there are three main data sources carrying information which is reburied for a highly automated data acquisition. These data sources are aerial images, digital surface models (DSM), which can either be derived by stereo matching from aerial images or be directly measured by scanning laser systems, and -- at least for highly developed countries -- existing (2D) GIS information on the ground plan or usage of buildings. The way these different data sources should be utilized by a process of 3D building reconstruction depends on the distinctive characteristics of the different, partly complementary type of information they contain. Image data contains much information, but just this complexity causes enormous problems for the automatic interpretation of this data type. The GIS as a secondary data source provides information on the 2D shape, i.e. the ground plan of a building, which is very reliable, although information on the third dimension is missing and therefore has to be provided by other data sources. As the information of a DSM is restricted to surface geometry, the interpretation of this kind of data is easier compared to the interpretation of image data. Nevertheless, due to insufficient spatial resolution or quality of the DSM, optimal results can only be achieved by the combination of all data sources. Within this paper two approaches aiming on the combination of aerial images, digital surface models and existing ground plans for the reconstruction of three- dimensional building reconstructions are demonstrated.
Larsen, Camilla Marie; Juul-Kristensen, Birgit; Lund, Hans
; (2) validity; and (3) responsiveness. Observational evaluation systems and assessment of scapular upward rotation seem suitably evidence-based for clinical use. Future studies should test and improve the clinimetric properties, and especially diagnostic accuracy and responsiveness, to increase...... excluded for evaluation due to no/few clinimetric results, leaving 35 studies for evaluation. Graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN checklist), the methodological quality in the reliability and validity domains was "fair" (57...
Samtani, Suraj; Moulds, Michelle L
Rumination and worry have recently been grouped under the broader transdiagnostic construct of repetitive thought (Watkins, 2008). The purpose of this review is to provide an overview of scales used to assess repetitive thinking across a broad range of contexts: depression, anxiety, trauma, stress, illness, interpersonal difficulties, positive affect, and so forth. We also include scales developed or adapted for children and adolescents. In the extant literature, measures of repetitive thinking generally show small-to-moderate correlations with measures of psychopathology. This review highlights problems with the content validity of existing instruments; for example, confounds between repetitive thought and symptomatology, metacognitive beliefs, and affect. This review also builds on previous reviews by including newer transdiagnostic measures of repetitive thinking. We hope that this review will help to expand our understanding of repetitive thinking beyond the mood and anxiety disorders, and suggest ways forward in the measurement of repetitive thinking in individuals with comorbid conditions. Copyright © 2017 Elsevier Ltd. All rights reserved.
Wagter, J.M.; van de Bunt, G.G.; Honing, M.; Eckenhausen, M.; Scherpbier, A.
Daily collaboration of senior doctors, residents and nurses involves a major potential for sharing knowledge between professionals. Therefore, more attention needs to be paid to informal learning to create strategies and appropriate conditions for enhancing and effectuating informal learning in the
Full Text Available Rune Erichsen1, Timothy L Lash1, Stephen J Hamilton-Dutoit2, Beth Bjerregaard3, Mogens Vyberg2,4, Lars Pedersen11Department of Clinical Epidemiology, 2Institute of Pathology, 4Aalborg Hospital, Aarhus University Hospital, Aarhus, Denmark; 3Department of Pathology and the Pathology Data Bank, Herlev University Hospital, Herlev, DenmarkAbstract: Diagnostic histological and cytological specimens are routinely stored in pathology department archives. These biobanks are a valuable research resource for many diseases, particularly if they can be linked to high quality population-based health registries, allowing large retrospective epidemiological studies to be carried out. Such studies are of significant importance, for example in the search for novel prognostic and predictive biomarkers in the era of personalized medicine. Denmark has a wealth of highly-regarded population-based registries that are ideally suited to conduct this type of epidemiological research. We describe two recent additions to these databases: the Danish National Pathology Registry (DNPR and its underlying national online registration database, the Danish Pathology Data Bank (DPDB. The DNPR and the DPDB contain detailed nationwide records of all pathology specimens analyzed in Denmark since 1997, and an incomplete but nonetheless valuable record of specimens from some pathology departments dating back to the 1970s. The data are of high quality and completeness and are sufficient to allow precise and efficient localization of the specimens. We describe the relatively uncomplicated procedures required to use these pathology databases in clinical research and to gain access to the archived specimens.Keywords: cohort profile, epidemiology, paraffin blocks, pathology
Евгений Геннадьевич Панкратов
Full Text Available This article analyzes the existing methods of e-government systems audit, their shortcomings are examined. The approaches to improve existing techniques and adapt them to the specific characteristics of e-government systems are suggested. The paper describes the methodology, providing possibilities of integrated assessment of information systems. This methodology uses systems maturity models and can be used in the construction of e-government rankings, as well as in the audit of their implementation process. Maturity models are based on COBIT, COSO methodologies and models of e-government, developed by the relevant committee of the UN. The methodology was tested during the audit of information systems involved in the payment of temporary disability benefits. The audit was carried out during analysis of the outcome of the pilot project for the abolition of the principle of crediting payments for disability benefits.DOI: http://dx.doi.org/10.12731/2218-7405-2014-2-5
Rémi de Bercegol
Full Text Available Despite being generally poorly recognized by public authorities, informal recycling remains nevertheless a major component in the waste sector, which questions the legitimacy of the official waste arrangements. A look at the current transformation in Hanoi (Vietnam, Delhi (India and Surabaya (Indonesia allows us to understand the socio-technical aspects of infrastructural choices in the management of waste generated in fast-growing Asian cities. The three cases present similar traditional recycling practices yet contrasted (non- regulation within their waste policies. From the co-existence of a municipal waste management service with a traditional informal recycling sector, to an opposition between both, there is also a possibility of making use of the existing local practices to achieve a more sustainable system.
Full Text Available Henry Jensen,1,2 Marie Louise Tørring,1 Mette Bach Larsen,3 Peter Vedsted11Research Unit for General Practice, Research Centre for Cancer Diagnosis in Primary Care, 2Section for General Medical Practice, Department of Public Health, Aarhus University, Aarhus C, 3Department of Public Health Programs, Randers Regional Hospital, Randers NOE, Denmark Background: In this paper, we describe the settings, content, and possibilities of the Danish Cancer in Primary Care (CaP cohort as well as some of the key findings so far. Further, we describe the future potential of the cohort as an international resource for epidemiological and health services research studies. Methods: The CaP cohort comprises information from three Danish subcohorts set up in 2004–2005, 2007–2008, and 2010 on newly diagnosed cancer patients aged 18 years or older. General practitioner (GP-reported and patient-reported data from six questionnaires generated information on causes and consequences of delayed diagnosis of cancer, and these data were supplemented with complete information on, eg, death, migration, health care utilization, medication use, and socioeconomic data from Denmark's comprehensive health and administrative registers. The cohort is followed up in terms of emigration, death, hospitalization, medication, and socioeconomics, and data are updated regularly. Results: In total, we identified 22,169 verified incident cancer cases. Completed GP questionnaires were returned for 17,566 (79% of the verified cases, and patient questionnaires were completed by 8,937 (40% respondents. Patients with participating GPs did not differ from patients with nonparticipating GPs in regard to one-year survival, comorbidity, or educational level. However, compared with nonparticipating GPs, patients listed with participating GPs were more likely to be women, younger, to have a higher disposable income, to have more regional or distant spread of tumors, were also more likely to have
Matsumoto, Kinzo; Zhao, Qi; Niu, Yimin; Fujiwara, Hironori; Tanaka, Ken; Sasaki-Hamada, Sachie; Oka, Jun-Ichiro
Cognitive deficits and behavioral and psychological symptoms of dementia (BPSD) are typical features of patients with dementia such as Alzheimer's disease (AD), vascular dementia (VD), and other forms of senile dementia. Clinical evidence has demonstrated the potential usefulness of chotosan (CTS) and yokukansan (YKS), traditional herbal formulations called Kampo medicines, in the treatment of cognitive disturbance and BPSD in dementia patients, although the indications targeted by CTS and YKS in Kampo medicine differ. The availability of CTS and YKS for treating dementia patients is supported by preclinical studies using animal models of dementia that include cognitive/emotional deficits caused by aging and diabetes, dementia risk factors. These studies have led not only to the concept of a neuronal basis for the CTS- and YKS-induced amelioration of cognitive function and emotional/psychiatric symptom-related behavior in animal models, but also to a proposal that ingredient(s) of Uncariae Uncis cum Ramulus, a medicinal herb included in CTS and YKS, may play an important role in the actions of these formulae in dementia patients. Further studies are needed to clarify the active ingredients of these formulae and their target endogenous molecules implicated in the anti-dementia drug-like actions.
Anuar, Tengku Shahrul; Al-Mekhlafi, Hesham M; Abdul Ghani, Mohamed Kamel; Azreen, Siti Nor; Salleh, Fatmah Md; Ghazali, Nuraffini; Bernadus, Mekadina; Moktar, Norhayati
The present study was conducted to investigate the clinical outcomes of Entamoeba histolytica infection in symptomatic and asymptomatic Orang Asli (aborigine) communities in Malaysia. Examination was performed on 500 stool samples obtained from Orang Asli communities in 3 different states using formalin-ether concentration, trichrome staining, and single-round PCR techniques. Out of 500 stool samples, single infection of E. histolytica, Entamoeba dispar, and Entamoeba moshkovskii was identified in 3.2%, 13.4%, and 1%, respectively. In addition, 10 samples had mixed infections with E. histolytica and E. dispar. Six samples containing E. dispar were also positive for E. moshkovskii, and only 2 samples had E. histolytica in association with E. dispar and E. moshkovskii. Seventeen E. histolytica-positive samples were from symptomatic subjects, whereas the remaining 11 samples came from asymptomatic subjects. These findings suggest a predominant distribution of pathogenic potential of E. histolytica strains in this community. Therefore, further studies on genotyping of E. histolytica is required, to find out association between E. histolytica genotype and the outcome of the infection.
Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana
Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.
de Jesus, Isabel Silva; Sena, Edite Lago da Silva; Andrade, Luana Machado
To describe the perception of lecturers and undergraduate nursing students regarding the dialogic experience in the informal spaces and its relationship with training in health. Experiential descriptions were collected in the context of a public university in the non-metropolitan region of the state of Bahia, Brazil, using open interviews. These descriptions were analyzed according to the principles of the phenomenology of Maurice Merleau-Ponty. It was revealed that the informal spaces contribute significantly to the construction of knowledge and professional training strengthening teaching and promoting the re-signification of the subjects' experience. It is evidenced that the dialogic experience has relevancy for rethinking the teaching-learning process in the university, such that the informal spaces should be included and valued as producers of meanings for the personal and academic life of lecturers and students, with the ability to re-signify existence.
Ratzan, Richard M.
Obtaining a valid informed consent from an elderly person, especially with possible senile dementia of the Alzheimer's type, first may involve solving the practical problems of effective communication. Impediments to effective communication with these individuals is discussed and suggestions for how to obviate them are given. (Author/BL)
Objective: To identify and highlight challenges related to informed consent process for clinical trials in sub-Saharan Africa. Data sources: Published original research findings and reviews in the English literature, together with anecdotal information from our current professional experiences with clinical trials. Design: Review ...
The regulation of informed consent to participation in clinical research by mentally ill persons in South Africa: An overview. A Nienaber. Abstract. The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. First, the juridical basis of ...
Wang, Xiao-Xia; Jin, Zhong-Zheng; Guo, Gui-Ming; Zhai, Hua-Qiang; Jin, Shi-Yuan
The aim of this study was to develop the data element standard directory of traditional Chinese medicine (TCM) clinical pharmacy information, to provide application standards and models of TCM clinical pharmacy for the electronic medical record (EMR). The developed line of work is as follows: initially establish research through four forms: literature analysis, questionnaires, discussion groups, expert advice. The research range from the Chinese herbal medicine research, herbal origin, harvesting, processing, identification of traits, physical and chemical identification, modern research, character, taste, Indications, clinical application, processing, dispensing medicine, Chinese medicine specifications, usage, dosage, caution, efficacy indications to small packaging applications, drug research, management and other related issues, including traditional Chinese medicine theory, application and hospital management information; according to the general and part 16 content of the national "Health Information Data Element Standards", and the basic method of extracting data element to study and develop the data element of TCM clinical pharmacy information from the defining content. Correspondingly propose the ideas and methods of construction of the "Data Element Standard Directory of TCM Clinical Pharmacy Information", sort out medicine clinical information data element standard catalog, divided into basic categories, clinical application class, management class three parts, and set norms and standards of identifying data elements, definitions, allowable value of traditional Chinese medicine clinical information, and discuss the sources and standards of information collection, leaving the interface, standardized and scientific terminology, docking with the existing standards, maintenance and management program and oter issues.
Full Text Available The creation of as-built Building Information Models requires the acquisition of the as-is state of existing buildings. Laser scanners are widely used to achieve this goal since they permit to collect information about object geometry in form of point clouds and provide a large amount of accurate data in a very fast way and with a high level of details. Unfortunately, the scan-to-BIM (Building Information Model process remains currently largely a manual process which is time consuming and error-prone. In this paper, a semi-automatic approach is presented for the 3D reconstruction of indoors of existing buildings from point clouds. Several segmentations are performed so that point clouds corresponding to grounds, ceilings and walls are extracted. Based on these point clouds, walls and slabs of buildings are reconstructed and described in the IFC format in order to be integrated into BIM software. The assessment of the approach is proposed thanks to two datasets. The evaluation items are the degree of automation, the transferability of the approach and the geometric quality of results of the 3D reconstruction. Additionally, quality indexes are introduced to inspect the results in order to be able to detect potential errors of reconstruction.
Dellson, Pia; Nilbert, Mef; Carlsson, Christina
BACKGROUND: Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed...... of future simplified and more attractive informed consent forms. CONCLUSIONS: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language...
Gorini, Alessandra; Mazzocco, Ketti; Pravettoni, Gabriella
Due to the lack of other treatment options, patient candidates for participation in phase I clinical trials are considered the most vulnerable, and many ethical concerns have emerged regarding the informed consent process used in the experimental design of such trials. Starting with these considerations, this nonsystematic review is aimed at analyzing the decision-making processes underlying patients' decision about whether to participate (or not) in phase I trials in order to clarify the cognitive and emotional aspects most strongly implicated in this decision. Considering that there is no uniform decision calculus and that many different variables other than the patient-physician relationship (including demographic, clinical, and personal characteristics) may influence patients' preferences for and processing of information, we conclude that patients' informed decision-making can be facilitated by creating a rigorously developed, calibrated, and validated computer tool modeled on each single patient's knowledge, values, and emotional and cognitive decisional skills. Such a tool will also help oncologists to provide tailored medical information that is useful to improve the shared decision-making process, thereby possibly increasing patient participation in clinical trials. © 2015 S. Karger AG, Basel.
Deléger, Louise; Campillos, Leonardo; Ligozat, Anne-Laure; Névéol, Aurélie
Knowledge representation frameworks are essential to the understanding of complex biomedical processes, and to the analysis of biomedical texts that describe them. Combined with natural language processing (NLP), they have the potential to contribute to retrospective studies by unlocking important phenotyping information contained in the narrative content of electronic health records (EHRs). This work aims to develop an extensive information representation scheme for clinical information contained in EHR narratives, and to support secondary use of EHR narrative data to answer clinical questions. We review recent work that proposed information representation schemes and applied them to the analysis of clinical narratives. We then propose a unifying scheme that supports the extraction of information to address a large variety of clinical questions. We devised a new information representation scheme for clinical narratives that comprises 13 entities, 11 attributes and 37 relations. The associated annotation guidelines can be used to consistently apply the scheme to clinical narratives and are https://cabernet.limsi.fr/annotation_guide_for_the_merlot_french_clinical_corpus-Sept2016.pdf . The information scheme includes many elements of the major schemes described in the clinical natural language processing literature, as well as a uniquely detailed set of relations.
Pollak, Michael N.
The data-handling problems associated with the administration of clinical trials of new treatments are more complex than those encountered in routine clinical practice. The reasons for this are reviewed, and various computer systems used to date (with mixed success) to aid researchers responsible for clinical trial administration are criticized. Careful analysis of clinical trial data-handling problems as perceived by the clinical researcher can lead to the design of improved computer systems capable of alleviating many of the problems commonly encountered when clinical trial data is collected and analyzed. Such systems are urgently needed as the number, size and complexity of clinical trials continue to increase. They are relatively easy to cost-justify because traditional methods of collecting and tabulating clinical trial data are amongst the most labour-intensive information-handling tasks encountered in clinical medicine. Our progress in the design and implementation of a computer system to aid in the administration of clinical trials is presented.
Cheong, B. J.; Kang, J. M.; Kim, H. S.; Koh, S. H.; Kang, D. H.; Park, C. H. [Cheju Univ., Jeju (Korea, Republic of)
The goal of this study is to estimate the relevance and Influence of the Existing Regulation and the RI-PBR to the institutionalization of the regulatory system. This study reviews the current regulatory system and the status of the RI-PBR implementation of the US NRC and Korea based upon SECY Papers, Risk Informed Regulation Implementation Plan (RIRIP) of the US NRC and other domestic studies. In order to investigate the perceptions, knowledge level, ground for the regulatory change, a survey was performed to Korean nuclear utilities, researchers and regulators on the perception on the RIR. The questionnaire was composed of 50 questions regarding personal details on work experience, level of education and specific field of work ; level of knowledge on the risk informed performance based regulation (RI-PBR); the perception of the current regulation, the effectiveness, level of procedure, flexibility, dependency on the regulator and personal view, and the perception of the RI-PBR such as flexibility of regulation, introduction time and the effect of RI-PBR, safety improvement, public perception, parts of the existing regulatory system that should be changed, etc. 515 answered from all sectors of the nuclear field; utilities, engineering companies, research institutes, and regulatory bodies.
Feng, Jing-yi; Chen, Hua; Zhu, Sheng-mei
To study the design, implementation and clinical evaluation of an anesthesia information management system. To record, process and store peri-operative patient data automatically, all kinds of bedside monitoring equipments are connected into the system based on information integrating technology; after a statistical analysis of those patient data by data mining technology, patient status can be evaluated automatically based on risk prediction standard and decision support system, and then anesthetist could perform reasonable and safe clinical processes; with clinical processes electronically recorded, standard record tables could be generated, and clinical workflow is optimized, as well. With the system, kinds of patient data could be collected, stored, analyzed and archived, kinds of anesthesia documents could be generated, and patient status could be evaluated to support clinic decision. The anesthesia information management system is useful for improving anesthesia quality, decreasing risk of patient and clinician, and aiding to provide clinical proof.
Chief information officers (CIOs) must play a pivotal role in the formation and implementation of a clinical information system, the subset of an organizational information system that deals specifically with support of clinical care activities. Major elements include the applications software, technology and data architecture, databases, and analysis. The organizational structures and processes that manage the development of improvement activities, including the clinical information system itself, are just as vital to the design of an information system as the hardware and software. To develop, sustain, and advance an information infrastructure, the CIO must help establish certain organizational precursors, such as medical staff involvement, experience with quality improvement, and ability to meet data needs. The CIO must then work with the senior administrative and medical leadership in developing a vision for the information system. The CIO must also create new roles and knowledge for information system and medical staff members. Interaction between information services and medical staff is vitally important to the success of a clinical information system. Organizational committees and structures that Brigham and Women's Hospital in Boston put in place to formalize the relationship between information systems and medical staff include the Clinical Initiative Development Program and the Center for Applied Medical Information Systems Research. Improving the clinical management of care and the efficacy of care processes involves complex changes in organizational culture and processes, medical practice and information system applications, technologies, staff, and data.
Kreimeyer, Kory; Foster, Matthew; Pandey, Abhishek; Arya, Nina; Halford, Gwendolyn; Jones, Sandra F; Forshee, Richard; Walderhaug, Mark; Botsis, Taxiarchis
We followed a systematic approach based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses to identify existing clinical natural language processing (NLP) systems that generate structured information from unstructured free text. Seven literature databases were searched with a query combining the concepts of natural language processing and structured data capture. Two reviewers screened all records for relevance during two screening phases, and information about clinical NLP systems was collected from the final set of papers. A total of 7149 records (after removing duplicates) were retrieved and screened, and 86 were determined to fit the review criteria. These papers contained information about 71 different clinical NLP systems, which were then analyzed. The NLP systems address a wide variety of important clinical and research tasks. Certain tasks are well addressed by the existing systems, while others remain as open challenges that only a small number of systems attempt, such as extraction of temporal information or normalization of concepts to standard terminologies. This review has identified many NLP systems capable of processing clinical free text and generating structured output, and the information collected and evaluated here will be important for prioritizing development of new approaches for clinical NLP. Copyright © 2017 Elsevier Inc. All rights reserved.
Wright, Adam; Sittig, Dean F
In this paper, we describe and evaluate a new distributed architecture for clinical decision support called SANDS (Service-oriented Architecture for NHIN Decision Support), which leverages current health information exchange efforts and is based on the principles of a service-oriented architecture. The architecture allows disparate clinical information systems and clinical decision support systems to be seamlessly integrated over a network according to a set of interfaces and protocols described in this paper. The architecture described is fully defined and developed, and six use cases have been developed and tested using a prototype electronic health record which links to one of the existing prototype National Health Information Networks (NHIN): drug interaction checking, syndromic surveillance, diagnostic decision support, inappropriate prescribing in older adults, information at the point of care and a simple personal health record. Some of these use cases utilize existing decision support systems, which are either commercially or freely available at present, and developed outside of the SANDS project, while other use cases are based on decision support systems developed specifically for the project. Open source code for many of these components is available, and an open source reference parser is also available for comparison and testing of other clinical information systems and clinical decision support systems that wish to implement the SANDS architecture. The SANDS architecture for decision support has several significant advantages over other architectures for clinical decision support. The most salient of these are:
Abalos, E; Chamillard, M; Diaz, V; Tuncalp, Ӧ; Gülmezoglu, A M
The World Health Organization (WHO) is in the process of updating antenatal care (ANC) guidelines. To map the existing clinical practice guidelines related to routine ANC for healthy women and to summarise all practices considered during routine ANC. A systematic search in four databases for all clinical practice guidelines published after January 2000. Two researchers independently assessed the list of potentially eligible publications. Information on scope of the guideline, type of practice, associated gestational age, recommendation type and the source of evidence were mapped. Of 1866 references, we identified 85 guidelines focusing on the ANC period: 15 pertaining to routine ANC and 70 pertaining to specific situations. A total of 135 interventions from routine ANC guidelines were extracted, and categorised as clinical interventions (n = 80), screening/diagnostic procedures (n = 47) and health systems related (n = 8). Screening interventions, (syphilis, anaemia) were the most common practices. Within the 70 specific situation guidelines, 102 recommendations were identified. Overall, for 33 (out of 171) interventions there were conflicting recommendations provided by the different guidelines. Mapping the current guidelines including practices related to routine ANC informed the scoping phase for the WHO guideline for ANC. Our analysis indicates that guideline development processes may lead to different recommendations, due to context, evidence base or assessment of evidence. It would be useful for guideline developers to map and refer to other similar guidelines and, where relevant, explore the discrepancies in recommendations and others. We identified existing ANC guidelines and mapped scope, practices, recommendations and source of evidence. © 2015 The Authors. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.
Yu, Hong; Cao, Yong-Gang
Automatically extracting information needs from ad hoc clinical questions is an important step towards medical question answering. In this work, we first explored supervised machine-learning approaches to automatically classify an ad hoc clinical question into general topics. We then evaluated different methods for automatically extracting keywords from an ad hoc clinical question. Our methods were evaluated on the 4,654 clinical questions maintained by the National Library of Medicine. Our best systems or methods showed F-score of 76% for the task of question-topic classification and an average F-score of 56% for extracting keywords from ad hoc clinical questions.
Melton, Genevieve B; Raman, Nandhini; Chen, Elizabeth S; Sarkar, Indra Neil; Pakhomov, Serguei; Madoff, Robert D
Family history information has emerged as an increasingly important tool for clinical care and research. While recent standards provide for structured entry of family history, many clinicians record family history data in text. The authors sought to characterize family history information within clinical documents to assess the adequacy of existing models and create a more comprehensive model for its representation. Models were evaluated on 100 documents containing 238 sentences and 410 statements relevant to family history. Most statements were of family member plus disease or of disease only. Statement coverage was 91%, 77%, and 95% for HL7 Clinical Genomics Family History Model, HL7 Clinical Statement Model, and the newly created Merged Family History Model, respectively. Negation (18%) and inexact family member specification (9.5%) occurred commonly. Overall, both HL7 models could represent most family history statements in clinical reports; however, refinements are needed to represent the full breadth of family history data.
The implementation of informed consent (IC) in clinical trials presents many challenges, especially in developing countries. This study explored the experiences and reported practices regarding the implementation of IC in clinical trials in South Africa. Data were gathered through semi-structured interviews with a range of ...
Sekeres, Melanie; Gold, Jennifer L; Chan, An-Wen; Lexchin, Joel; Moher, David; Van Laethem, Marleen L P; Maskalyk, James; Ferris, Lorraine; Taback, Nathan; Rochon, Paula A
In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The objective is to examine the proportion of registered clinical trials providing valid scientific leadership information. We reviewed clinical trial entries listing Canadian investigators in the two largest international and public trial registers, the International Standard Randomized Controlled Trial Number (ISRCTN) register, and ClinicalTrials.gov. The main outcome measures were the proportion of clinical trials reporting valid contact information for the trials' Principal Investigator (PI)/Co-ordinating Investigator/Study Chair/Site PI, and trial e-mail contact address, stratified by funding source, recruiting status, and register. A total of 1388 entries (142 from ISRCTN and 1246 from ClinicalTrials.gov) comprised our sample. We found non-compliance with mandatory registration requirements regarding scientific leadership and trial contact information. Non-industry and partial industry funded trials were significantly more likely to identify the individual responsible for scientific leadership (OR = 259, 95% CI: 95-701) and to provide a contact e-mail address (OR = 9.6, 95% CI: 6.6-14) than were solely industry funded trials. Despite the requirements set by WHO and ICMJE, data on scientific leadership and contact e-mail addresses are frequently omitted from clinical trials registered in the two leading public clinical trial registers. To promote accountability and transparency in clinical trials research, public clinical trials registers should ensure adequate monitoring of trial
Matsumura, A; Ahyai, A; Hori, A; Schaake, T
The frequency of asymptomatic subependymomas was 0.4% in 1,000 serial routine necropsies and 0.7% in symptomatic subependymomas from 1,000 serial surgical specimens of intracranial neoplasms. Among patients with subependymoma (7 symptomatic and 4 asymptomatic), we found 3 cases of marked nuclear polymorphism (NP) in biopsy specimens. The subjective NP was objectively quantified by computer-assisted morphometry, by which a significant difference in nuclear size between these three cases and other cases (p less than 0.005) was revealed. This morphological characteristic correlated with the results of DNA-analysis by flow fluorescence cytometry (FFCM): subependymomas with NP demonstrated higher S and G2/M phases in a diploid pattern than other benign gliomas of our series. From the clinical data including prognosis, however, no remarkable difference was found between the NP group and other groups. The possible existence of less benign variant should be considered in the diagnosis and treatment of subependymoma.
Dorfer, Christof E; Joerss, Daniela; Wolff, Diana
To evaluate gingival recession changes after six months of brushing with an oscillating-rotating power toothbrush (PT) or an ADA reference manual toothbrush (MT). Healthy subjects with pre-existing recession were assigned to brush with either a PT (n=55) or an ADA reference MT (n=54) according to a prospective randomized, controlled, single-blind, parallel group design. Participants were asked to brush their teeth twice daily for two minutes each with the same fluoride toothpaste. Clinical attachment loss and probing pocket depths (PPDs) were measured at six sites per tooth to the nearest mm by one calibrated examiner at baseline and after six months. Gingival recession was calculated as the differences between clinical attachment loss and PPDs overall and separately at individual sites. As compared with baseline, overall recession at six months was reduced from 2.35 +/- 0.35 mm to 1.98 +/- 0.55 mm (p<0.001) in the PT group and from 2.26 +/- 0.31 mm to 1.90 +/- 0.45 mm (p<0.001) in the MT group. The data showed 40% (power) and 38% (manual) of all recession sites improved by at least 0.5 mm while 51% and 54% remained unchanged. Eight percent and 7% recessions increased over time. Differences between groups were not statistically significant at either timepoint. Both the PT and the MT significantly reduced pre-existing gingival recession after six months of brushing. This may have been due to improved brushing technique (i.e., Hawthorne effect). Based on these six-month data, concern that power tooth brushing results in a higher risk for gingival recession is not warranted.
McElroy, Mark J; Sponseller, Paul D; Fuhrhop, Sara K; Russell, Colin J; Newton, Peter O; Marks, Michelle C; Sanders, James O; Yazici, Muharrem; Pawelek, Jeff B; Akbarnia, Behrooz A
Retrospective analysis. To determine if statistically significant differences exist between operative idiopathic early-onset scoliosis (IEOS) and adolescent idiopathic scoliosis (AIS) in primary curve characteristics, stable vertebra, kyphosis, or lumbar deformity and, if so, to identify the clinical significance of these differences. To our knowledge, no study has statistically compared radiographical measures of operative IEOS and AIS. We identified operative patients (60, IEOS; 1537, AIS) in 2 multicenter databases and measured preoperative radiographical parameters of interest. The measurements were compared using the Student t test and other appropriate statistical methods (significance, P = 0.05). The IEOS and AIS groups were significantly different in primary curve magnitude (70° ± 20° vs. 54° ± 13°, respectively; P exist between operative IEOS and AIS curves. IEOS curves are greater in magnitude, more kyphotic, less well compensated, and have a more caudal apex and stable vertebra. These findings suggest that younger patients may require more distal instrumentation and that proximal fixation techniques should consider the additional pullout forces created by the greater kyphosis.
Hietanen, P; Aro, A R; Holli, K
for decision-making. Less educated patients and older patients had needed more time. Eighty-seven per cent (218/251) were happy with their decision to participate. While most patients are satisfied with the information received, there is a poor understanding of how treatment is allocated. Information should...... be modified for older and less-educated patients. The needs of the patients when offered participation in a clinical trial are clear information, enough time to consider the options and psychological support....
Full Text Available Background: It is widely recognized that accurate and reliable product information is essential for the safe and effective use of medications. Pharmaceutical companies are the primary source of most drug information, including package inserts. Package inserts are printed leaflets accompanying marketed drug products and contain information approved by the regulatory agencies. Studies on package inserts in India, in 1996, had shown that crucial information was often missing and they lacked uniformity. Aim: To assess the presentation and completeness of clinically important information provided in the currently available package inserts in India. Materials and Methods: Package inserts accompanying allopathic drug products marketed by pharmaceutical companies in India were collected. These package inserts were analyzed for the content of clinically important information in various sections. Statistical Analysis: The results were expressed as absolute numbers and percentages. Results: Preliminary analyses revealed that most package inserts did contain information under headings, such as, therapeutic indications, contraindications, undesirable effects, etc., listed in the Drugs and Cosmetics Rules 1945. The findings indicated considerable improvement in package inserts since 1996. However, on critical evaluation it was revealed that clinically important information was not well presented and was often incomplete. Information with regard to pediatric and geriatric use was present in only 44% and 13% of the package inserts, respectively. Only five of the inserts had information on the most frequent adverse drug reactions associated with the drug. Also, information on interactions and overdosage was often missing. Conclusion: Although the package inserts appear to have improved over the past decade there is still a definite need to further refine the clinical information contained, to minimize the risks to patients. This could be brought about by self
Jensen, Sanne; Lyng, Karen Marie; Nøhr, Christian
high fidelity environments. The paper discusses how simulation may be used during the lifecycle of clinical information systems, and the requirements on simulation fidelity in various situations. We recommend that simulation should get a more prominent role in the design and evaluation of clinical...... systems. Simulation is especially well suited for the evaluation of human factors and organizational aspects in relation to application of information systems. In full-scale simulation tests it is possible to evaluate socio-technical interaction. A near to real life experience can be achieved by creating...... information systems....
Irigoien, Itziar; Arenas, Concepción
In diagnosis and classification diseases multiple outcomes, both molecular and clinical/pathological are routinely gathered on patients. In recent years, many approaches have been suggested for integrating gene expression (continuous data) with clinical/pathological data (usually categorical and ordinal data). This new area of research integrates both clinical and genomic data in order to improve our knowledge about diseases, and to capture the information which is lost in independent clinical or genomic studies. The related metric scaling distance is a not well-known, but very valuable distance to integrate clinical/pathological and molecular information. In this article, we present the use of the related metric scaling distance in biomedical research. We describe how this distance works, and we also explain why it may sometimes be preferred. We discuss the choice of the related metric scaling distance and compare it with other proximity measures to include both clinical and genetic information. Furthermore, we comment the choice of the related metric scaling distance when classical clustering or discriminant analysis based on distances are performed and compare the results with more complex cluster or discriminant procedures specially constructed for integrating clinical and molecular information. The use of the related metric scaling distance is illustrated on simulated experimental and four real data sets, a heart disease, and three cancer studies. The results present the flexibility and availability of this distance which gives competitive results. © The Author(s) 2014.
Goossen, William T F
This paper will present an overview of the developmental effort in harmonizing clinical knowledge modeling using the Detailed Clinical Models (DCMs), and will explain how it can contribute to the preservation of Electronic Health Records (EHR) data. Clinical knowledge modeling is vital for the management and preservation of EHR and data. Such modeling provides common data elements and terminology binding with the intention of capturing and managing clinical information over time and location independent from technology. Any EHR data exchange without an agreed clinical knowledge modeling will potentially result in loss of information. Many attempts exist from the past to model clinical knowledge for the benefits of semantic interoperability using standardized data representation and common terminologies. The objective of each project is similar with respect to consistent representation of clinical data, using standardized terminologies, and an overall logical approach. However, the conceptual, logical, and the technical expressions are quite different in one clinical knowledge modeling approach versus another. There currently are synergies under the Clinical Information Modeling Initiative (CIMI) in order to create a harmonized reference model for clinical knowledge models. The goal for the CIMI is to create a reference model and formalisms based on for instance the DCM (ISO/TS 13972), among other work. A global repository of DCMs may potentially be established in the future.
George, Sheba; Garth, Belinda; Fish, Allison; Baker, Richard
Urban safety-net clinics are considered prime targets for the adoption of health information technology innovations; however, little is known about their utilization in such safety-net settings. Current scholarship provides limited guidance on the implementation of health information technology into safety-net settings as it typically assumes that adopting institutions have sufficient basic resources. This study addresses this gap by exploring the unique challenges urban resource-poor safety-net clinics must consider when adopting and utilizing health information technology. In-depth interviews (N = 15) were used with key stakeholders (clinic chief executive officers, medical directors, nursing directors, chief financial officers, and information technology directors) from staff at four clinics to explore (a) nonhealth information technology-related clinic needs, (b) how health information technology may provide solutions, and (c) perceptions of and experiences with health information technology. Participants identified several challenges, some of which appear amenable to health information technology solutions. Also identified were requirements for effective utilization of health information technology including physical infrastructural improvements, funding for equipment/training, creation of user groups to share health information technology knowledge/experiences, and specially tailored electronic billing guidelines. We found that despite the potential benefit that can be derived from health information technologies, the unplanned and uninformed introduction of these tools into these settings might actually create more problems than are solved. From these data, we were able to identify a set of factors that should be considered when integrating health information technology into the existing workflows of low-resourced urban safety-net clinics in order to maximize their utilization and enhance the quality of health care in such settings.
Allstadt, Kate E.; Thompson, Eric M.; Hearne, Mike; Nowicki Jessee, M. Anna; Zhu, J.; Wald, David J.; Tanyas, Hakan
The U.S. Geological Survey (USGS) has made significant progress toward the rapid estimation of shaking and shakingrelated losses through their Did You Feel It? (DYFI), ShakeMap, ShakeCast, and PAGER products. However, quantitative estimates of the extent and severity of secondary hazards (e.g., landsliding, liquefaction) are not currently included in scenarios and real-time post-earthquake products despite their significant contributions to hazard and losses for many events worldwide. We are currently running parallel global statistical models for landslides and liquefaction developed with our collaborators in testing mode, but much work remains in order to operationalize these systems. We are expanding our efforts in this area by not only improving the existing statistical models, but also by (1) exploring more sophisticated, physics-based models where feasible; (2) incorporating uncertainties; and (3) identifying and undertaking research and product development to provide useful landslide and liquefaction estimates and their uncertainties. Although our existing models use standard predictor variables that are accessible globally or regionally, including peak ground motions, topographic slope, and distance to water bodies, we continue to explore readily available proxies for rock and soil strength as well as other susceptibility terms. This work is based on the foundation of an expanding, openly available, case-history database we are compiling along with historical ShakeMaps for each event. The expected outcome of our efforts is a robust set of real-time secondary hazards products that meet the needs of a wide variety of earthquake information users. We describe the available datasets and models, developments currently underway, and anticipated products.
Wong, Ming Chao; Yee, Kwang Chien; Turner, Paul
Improving clinical communication is imperative to improving the quality and safety of patient care. Significant efforts have been made to improve clinical communication and patient safety, guided by the mantra of "the right information, to the right person, in the right place, at the right time". The design and implementation of information communication technologies (ICTs) has been considered as one of the major developments in improving patient care. Clinical communication in today's clinical practice is complex and involves multi-disciplinary teams using different types of media for information transfer. This paper argues that traditional communication theories fail to adequately capture and describe contemporary clinical communicative practices or to provide insight into how information transferred is actually assimilated and/or utilised for patient care. This paper argues for the need to more fully consider underlying assumptions about the role of information in clinical communication and to recognise how the attributes of information receivers, especially where ICTs are deployed influence outcomes. The paper presents a discussion regarding the need to consider information receivers as the foundation for clinical communication improvement and future design and development of ICTs to improve patient care.
Crosignani, Pier Giorgio; Glasier, Anna
BACKGROUND This paper explores recent developments in female contraception, using them to illustrate how adaptation of existing methods, improved service delivery and understanding contraceptive behaviour might increase contraceptive uptake and correct and consistent use, and how the development of new methods holds some promise for capitalizing on the potential non-contraceptive benefits. METHODS Searches were performed in Medline and other databases. Selection criteria included high-quality studies and studies relevant to clinical reproductive medicine. Summaries were presented and discussed by the European Society of Human Reproduction and Embryology (ESHRE) Workshop Group. RESULTS The topics discussed include: adapted regimens for combined oral contraceptive pills, non-invasive methods of female sterilization, the need to improve the awareness of pregnancy risk to increase the use of emergency contraception, improvements in the evidence base for the safety and service delivery of intrauterine methods, emphasis on the potential benefits of combined oral contraceptives for women with hirsutism and acne, the potential of female sterilization to prevent ovarian cancer, and the promise of anti-progesterones and new approaches to dual protection. CONCLUSIONS Although great strides have been made in recent years in increasing contraceptive use among women in many countries where contraceptive prevalence is low or there is a high unmet need for contraception, much more can, and needs to, be done.
Foster, R.F.; Rickard, W.H.; Strand, J.A.; Warner, M.L.
Reconnaissance level information (RLI) sufficient for comparing the environmental and socio-economic features of candidate sites for nuclear power stations and for guiding plant design, baseline surveys, and operational practices is usually available from published reports, public records, and knowledgeable individuals. Environmental concerns of special importance for site evaluation include: aquatic ecology, terrestrial ecology, land and water use, socio-economics, and institutional constraints. A scheme is suggested for using RLI to assign classifications to candidate sites based on the potential level of concern associated with the different environmental features.
Full Text Available A prototyping approach was used to determine the essential system requirements of a computerised patient record information system for a typical township primary health care clinic. A pilot clinic was identified and the existing manual system and business processes in this clinic was studied intensively before the first prototype was implemented. Interviews with users, incidental observations and analysis of actual data entered were used as primary techniques to refine the prototype system iteratively until a system with an acceptable data set and adequate functionalities were in place. Several non-functional and user-related requirements were also discovered during the prototyping period.
Full Text Available Morten Schiodt,1 Cecilia Larsson Wexell,2,3 Bente Brokstad Herlofson,4 Karen Marie Giltvedt,4 Sven Erik Norholt,5 Vera Ehrenstein61Department of Oral and Maxillofacial Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 2Department of Oral and Maxillofacial Surgery, Södra Älvsborg Hospital, Region Västra Götaland, Borås, 3Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; 4Department of Oral Surgery and Oral Medicine, Faculty of Dentistry, University of Oslo, Oslo, Norway; 5Department of Oral and Maxillofacial Surgery, Aarhus University and University Hospital, 6Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, DenmarkAbstract: Osteonecrosis of the jaw (ONJ is a severe side effect associated with antiresorptive treatment. Monitoring of ONJ using routine databases in Scandinavian countries is a challenge owing to lack of valid algorithms and to heterogeneous referral practices. The aim of this paper is to describe the process of establishing a Scandinavian ONJ Cohort enrolling all ONJ cases related to antiresorptive treatment arising in Denmark, Norway, and Sweden between 2011 and 2019. The initial purpose of the cohort is to support an ongoing pharmacovigilance study of denosumab and zoledronic acid in Denmark, Norway, and Sweden. The three countries, with their 199 clinics, departments, and units of oral and maxillofacial surgery, both hospital-based and freestanding, differ somewhat in referral practices of the ONJ patients. By directly contacting all providers of care to ONJ patients in the three countries, we established a network for reporting incident cases to each country's research database directly or through a member of the Scandinavian ONJ task force as a liaison. The task force includes a Scandinavian coordinator and three national coordinators collaborating directly with the clinics. A uniform ONJ
Mathura, Venkatarajan S; Rangareddy, Mahendiranath; Gupta, Pankaj; Mullan, Michael
Clinical trials involve multi-site heterogeneous data generation with complex data input-formats and forms. The data should be captured and queried in an integrated fashion to facilitate further analysis. Electronic case-report forms (eCRF) are gaining popularity since it allows capture of clinical information in a rapid manner. We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for efficient design and deployment of eCRFs to efficiently collate data and analyze information from multi-site clinical trials. The main components of our system include an XML form designer, a Patient registration eForm, reusable eForms, multiple-visit data capture and consolidated reports. A unique id is used for tracking the trial, site of occurrence, the patient and the year of recruitment. Availability http://www.rfdn.org/bioinfo/CTMS/ctms.html. PMID:21670796
Cao, Xinhua; Hoo, Kent S., Jr.; Zhang, Hong; Ching, Wan; Zhang, Ming; Wong, Stephen T. C.
We described a web-based data warehousing method for retrieving and analyzing neurological multimedia information. The web-based method supports convenient access, effective search and retrieval of clinical textual and image data, and on-line analysis. To improve the flexibility and efficiency of multimedia information query and analysis, a three-tier, multimedia data warehouse for epilepsy research has been built. The data warehouse integrates clinical multimedia data related to epilepsy from disparate sources and archives them into a well-defined data model.
Kim, Eun Jin; Kim, Su Hyun
This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.
McMahon, L F; Eward, A M; Bernard, A M; Hayward, R A; Billi, J E; Rosevear, J S; Southwell, D
The rising cost of health care has increased the call for cost control. The pressing need to control cost, coupled with the increase in managed care and prospective payment, has placed new urgency on administrators and clinicians to work collaboratively in providing efficient and effective care. We have developed the Integrated Inpatient Management Model (IIMM) to assist in this collaborative effort. We describe the IIMM's clinical information system that provides decision support to both administrators and clinicians. This clinical information system is the information backbone for the development and monitoring of practice guidelines or critical pathways. An integrated information system of this type is essential if hospitals are to prosper during the next decade.
Urquhart, Christine; Turner, Janet; Durbin, Jane; Ryan, Jean
Objectives: The eighteen-month evaluation of a clinical librarian project (October 2003–March 2005) conducted in North Wales, United Kingdom (UK) assessed the benefits of clinical librarian support to clinical teams, the impact of mediated searching services, and the effectiveness of information skills training, including journal club support. Methods: The evaluation assessed changes in teams' information-seeking behavior and their willingness to delegate searching to a clinical librarian. Baseline (n = 69 responses, 73% response rate) and final questionnaire (n = 57, 77% response rate) surveys were complemented by telephone and face-to-face interviews (n = 33) among 3 sites served. Those attending information skills training sessions (n = 130) completed evaluations at the session and were surveyed 1 month after training (n = 24 questionnaire responses, n = 12 interviews). Results: Health professionals in clinical teams reported that they were more willing to undertake their own searching, but also more willing to delegate some literature searching, than at the start of the project. The extent of change depended on the team and the type of information required. Information skills training was particularly effective when organized around journal clubs. Conclusions: Collaboration with a clinical librarian increased clinician willingness to seek information. Clinical librarian services should leverage structured training opportunities such as journal clubs. PMID:17252062
Urquhart, Christine; Turner, Janet; Durbin, Jane; Ryan, Jean
The eighteen-month evaluation of a clinical librarian project (October 2003-March 2005) conducted in North Wales, United Kingdom (UK) assessed the benefits of clinical librarian support to clinical teams, the impact of mediated searching services, and the effectiveness of information skills training, including journal club support. The evaluation assessed changes in teams' information-seeking behavior and their willingness to delegate searching to a clinical librarian. Baseline (n = 69 responses, 73% response rate) and final questionnaire (n = 57, 77% response rate) surveys were complemented by telephone and face-to-face interviews (n = 33) among 3 sites served. Those attending information skills training sessions (n = 130) completed evaluations at the session and were surveyed 1 month after training (n = 24 questionnaire responses, n = 12 interviews). Health professionals in clinical teams reported that they were more willing to undertake their own searching, but also more willing to delegate some literature searching, than at the start of the project. The extent of change depended on the team and the type of information required. Information skills training was particularly effective when organized around journal clubs. Collaboration with a clinical librarian increased clinician willingness to seek information. Clinical librarian services should leverage structured training opportunities such as journal clubs.
Ananthanarayanan, C.V.; Janakiramaiah, N.; Gangadhar, B.N.; Vittal, S.; Andade, C.; Kumaraiah, V.
SUMMARY Twenty four remitted schizophrenics and twenty four neurotic depressives were studied on three measures of visual information processing, viz., simple reaction time, choice reaction time, and a forced choice span of apprehension test. The groups were matched for age, sex, and educational status. The remitted schizophrenics performed poorly on these measures compared to neurotic depressives. The findings suggest that information processing deficits are present in outpatient schizophrenics even during clinical remission. PMID:21776163
McEnery, K W; Suitor, C T; Hildebrand, S; Downs, R L
Efficient access to information systems integrated into the radiologist's interpretation workflow will result in a more informed radiologist, with an enhanced capability to render an accurate interpretation. We describe our implementation of radStation, a radiologist's clinical information review workstation that combines a digital dictation station with a clinical information display. radStation uses client software distributed to the radiologist's workstation and central server software, both running Windows NT (Microsoft, Redmond, WA). The client system has integrated digital dictation software. The bar-code microphone (Boomerang, Dictaphone Corp, Stratford, CT) also serves as a computer input device forwarding the procedure's accession number to the server software. This initiates multiple queries to available legacy databases, including the radiology information system (RIS), laboratory information system, clinic notes, hospital discharge, and operative report system. The three-tier architecture then returns the clinical results to the radStation client for display. At the conclusion of the dictation, the digital voice file is transferred to the dictation server and the client notifies the RIS to update the examination status. The system is efficient in its information retrieval, with queries displayed in about 1 second. The radStation client requires less than 5 minutes of radiologist training in its operation, given that its control interface integrates with the well-learned dictation process. The telephone-based dictation system, which this new system replaced, remains available as a back-up system in the event of an unexpected digital dictation system failure. This system is well accepted and valued by the radiologists. The system interface is quickly mastered. The system does not interrupt dictation workflow with the display of all information initiated with examination bar-coding. This system's features could become an accepted model as a standard tool
Hripcsak, G; Cimino, J J; Sengupta, S
WebCIS is a Web-based clinical information system. It sits atop the existing Columbia University clinical information system architecture, which includes a clinical repository, the Medical Entities Dictionary, an HL7 interface engine, and an Arden Syntax based clinical event monitor. WebCIS security features include authentication with secure tokens, authorization maintained in an LDAP server, SSL encryption, permanent audit logs, and application time outs. WebCIS is currently used by 810 physicians at the Columbia-Presbyterian center of New York Presbyterian Healthcare to review and enter data into the electronic medical record. Current deployment challenges include maintaining adequate database performance despite complex queries, replacing large numbers of computers that cannot run modern Web browsers, and training users that have never logged onto the Web. Although the raised expectations and higher goals have increased deployment costs, the end result is a far more functional, far more available system.
Choi, Eun-Kyoung; Kim, Mi-Jung; Lim, Nam-Kyoo; Park, Hyun-Young
Clinical research registration is required in many countries to improve transparency of clinical research and to ensure subject safety. Developed in February 2010, the Clinical Research Information Service (CRIS) is an online registration system for clinical studies in Korea and one of the primary registries of the World Health Organization (WHO) International Clinical Trials Registry Platform. The present analysis investigated the characteristics of studies registered in the CRIS between February 2010 and December 2014. Data for the analysis were extracted from the CRIS database. As of December 31, 2014, 1,323 clinical studies were registered. Of these, 938 (70.9%) were interventional studies and 385 (29.1%) were observational studies. A total of 248 (18.7%) studies were funded by government sources, 1,051 (79.4%) by non-government sources, and 24 (1.8%) by both. The most frequently studied disease category based on the ICD-10 classification was the digestive system (13.1%), followed by the nervous system (9.4%) and musculoskeletal system (9.1%). Only 17.8% of the studies were registered prior to enrollment of the first subject. Comparing the number of registered or approved clinical studies between the CRIS, the Ministry of Food and Drug Safety, and ClinicalTrials.gov suggests that a considerable number of clinical studies are not registered with the CRIS; therefore, we would suggest that such registration should be the mandatory legal requirement.
Welch, Brandon M; Loya, Salvador Rodriguez; Eilbeck, Karen; Kawamoto, Kensaku
Whole genome sequence (WGS) information may soon be widely available to help clinicians personalize the care and treatment of patients. However, considerable barriers exist, which may hinder the effective utilization of WGS information in a routine clinical care setting. Clinical decision support (CDS) offers a potential solution to overcome such barriers and to facilitate the effective use of WGS information in the clinic. However, genomic information is complex and will require significant considerations when developing CDS capabilities. As such, this manuscript lays out a conceptual framework for a CDS architecture designed to deliver WGS-guided CDS within the clinical workflow. To handle the complexity and breadth of WGS information, the proposed CDS framework leverages service-oriented capabilities and orchestrates the interaction of several independently-managed components. These independently-managed components include the genome variant knowledge base, the genome database, the CDS knowledge base, a CDS controller and the electronic health record (EHR). A key design feature is that genome data can be stored separately from the EHR. This paper describes in detail: (1) each component of the architecture; (2) the interaction of the components; and (3) how the architecture attempts to overcome the challenges associated with WGS information. We believe that service-oriented CDS capabilities will be essential to using WGS information for personalized medicine.
The workshops used role-playing simulations, to demonstrate how to effectively obtain fuller IC, to members of several Japanese research groups preparing for clinical stem cell trials. Workshop results were correlated with the results of a 2013 workshop on what information patients want when considering participation in ...
Kimmelman, Jonathan; London, Alex John
The so-called drug pipeline is not really about drugs and not much like a pipeline. It is really about the production and dissemination of information, and it is much more like a web. The misunderstanding leads to a poor understanding of what's wrong with clinical translation and how it can be improved.
... decisions and disclosure of requested information; time limits. 792.56 Section 792.56 Banks and Banking... ADMINISTRATION REQUESTS FOR INFORMATION UNDER THE FREEDOM OF INFORMATION ACT AND PRIVACY ACT, AND BY SUBPOENA..., access decisions and disclosure of requested information; time limits. (a) The system manager identified...
Schmitz, Vanessa; Boukhari, Marta Rosecler Bez el [Centro Universitario Feevale, Novo Hamburgo/RS (Brazil)
This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system.
Schmitz, Vanessa; Rosecler Bez el Boukhari, Marta
This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system.
Raghavan, Preethi; Chen, James L; Fosler-Lussier, Eric; Lai, Albert M
Electronic health records capture patient information using structured controlled vocabularies and unstructured narrative text. While structured data typically encodes lab values, encounters and medication lists, unstructured data captures the physician's interpretation of the patient's condition, prognosis, and response to therapeutic intervention. In this paper, we demonstrate that information extraction from unstructured clinical narratives is essential to most clinical applications. We perform an empirical study to validate the argument and show that structured data alone is insufficient in resolving eligibility criteria for recruiting patients onto clinical trials for chronic lymphocytic leukemia (CLL) and prostate cancer. Unstructured data is essential to solving 59% of the CLL trial criteria and 77% of the prostate cancer trial criteria. More specifically, for resolving eligibility criteria with temporal constraints, we show the need for temporal reasoning and information integration with medical events within and across unstructured clinical narratives and structured data.
Zhang, Yuanpeng; Dong, Jiancheng; Qian, Danmin; Geng, Xingyun; Wu, Huiqun; Wang, Li
Clinic expert information provides important references for residents in need of hospital care. Usually, such information is hidden in the deep web and cannot be directly indexed by search engines. To extract clinic expert information from the deep web, the first challenge is to make a judgment on forms. This paper proposes a novel method based on a domain model, which is a tree structure constructed by the attributes of search interfaces. With this model, search interfaces can be classified to a domain and filled in with domain keywords. Another challenge is to extract information from the returned web pages indexed by search interfaces. To filter the noise information on a web page, a block importance model is proposed. The experiment results indicated that the domain model yielded a precision 10.83% higher than that of the rule-based method, whereas the block importance model yielded an F₁ measure 10.5% higher than that of the XPath method.
de Mul, Marleen; Alons, Peter; van der Velde, Peter; Konings, Ilse; Bakker, Jan; Hazelzet, Jan
There are relatively few institutions that have developed clinical data warehouses, containing patient data from the point of care. Because of the various care practices, data types and definitions, and the perceived incompleteness of clinical information systems, the development of a clinical data warehouse is a challenge. In order to deal with managerial and clinical information needs, as well as educational and research aims that are important in the setting of a university hospital, Erasmus Medical Center Rotterdam, The Netherlands, developed a data warehouse incrementally. In this paper we report on the in-house development of an integral part of the data warehouse specifically for the intensive care units (ICU-DWH). It was modeled using Atos Origin Metadata Frame method. The paper describes the methodology, the development process and the content of the ICU-DWH, and discusses the need for (clinical) data warehouses in intensive care. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
Suebnukarn, Siriwan; Chanakarn, Piyawadee; Phisutphatthana, Sirada; Pongpatarat, Kanchala; Wongwaithongdee, Udom; Oupadissakoon, Chanekrid
An understanding of the processes of clinical decision-making is essential for the development of health information technology. In this study we have analysed the acquisition of information during decision-making in oral surgery, and analysed cognitive tasks using a "think-aloud" protocol. We studied the techniques of processing information that were used by novices and experts as they completed 4 oral surgical cases modelled from data obtained from electronic hospital records. We studied 2 phases of an oral surgeon's preoperative practice including the "diagnosis and planning of treatment" and "preparing for a procedure". A framework analysis approach was used to analyse the qualitative data, and a descriptive statistical analysis was made of the quantitative data. The results showed that novice surgeons used hypotheticodeductive reasoning, whereas experts recognised patterns to diagnose and manage patients. Novices provided less detail when they prepared for a procedure. Concepts regarding "signs", "importance", "decisions", and "process" occurred most often during acquisition of information by both novices and experts. Based on these results, we formulated recommendations for the design of clinical information technology that would help to improve the acquisition of clinical information required by oral surgeons at all levels of expertise in their clinical decision-making. Copyright © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
A. Attarbaschi (Andishe); Carraro, E. (Elisa); O. Abla (Oussama); Barzilai-Birenboim, S. (Shlomit); S. Bomken (Simon); L. Brugières (Laurence); Bubanska, E. (Eva); B. Burkhardt (Birgit); Chiang, A.K.S. (Alan K. S.); M. Csoka (Monika); Fedorova, A. (Alina); J. Jazbec; E. Kabickova (Edita); Z. Krenova (Zdenka); Lazic, J. (Jelena); J. Loeffen; Mann, G. (Georg); F. Niggli (Felix); Miakova, N. (Natalia); Osumi, T. (Tomoo); Ronceray, L. (Leila); A. Uyttebroeck (Anne); D. Williams; Woessmann, W. (Wilhelm); G. Wrobel (Grazyna); Pillon, M. (Marta)
textabstractChildren and adolescents with pre-existing conditions such as DNA repair defects or other primary immunodeficiencies have an increased risk of non-Hodgkin lymphoma. However, largescale data on patients with non-Hodgkin lymphoma and their entire spectrum of pre-existing conditions are
McEnery, K W; Suitor, C T; Hildebrand, S; Downs, R
RadStation is a digital dictation system having an integrated display of clinical information. The three-tiered system architecture provides robust performance, with most information displayed within one second after a request. The multifunctional client tier is a unique client/browser hybrid. A Web browser display window functions as the client application's data display window for clinical information, radiology reports, and laboratory and pathology results. RadStation provides a robust platform for digital dictation functionality. The system's internal status checks ensure operational integrity in a clinical environment. Also, the programmable dictation microphone and bar-code reader supplant the mouse as the system's primary input device. By merging information queries into existing work flow, radiologist's interpretation efficiency is maintained with instant access to essential clinical information. Finally, RadStation requires minimal training and has been enthusiastically accepted by our radiologists in an active clinical practice.
Pollack, Ari H; Miller, Andrew; Mishra, Sonali R; Pratt, Wanda
Participatory design, a method by which system users and stakeholders meaningfully contribute to the development of a new process or technology, has great potential to revolutionize healthcare technology, yet has seen limited adoption. We conducted a design session with eleven physicians working to create a novel clinical information tool utilizing participatory design methods. During the two-hour session, the physicians quickly engaged in the process and generated a large quantity of information, informing the design of a future tool. By utilizing facilitators experienced in design methodology, with detailed domain expertise, and well integrated into the healthcare organization, the participatory design session engaged a group of users who are often disenfranchised with existing processes as well as health information technology in general. We provide insight into why participatory design works with clinicians and provide guiding principles for how to implement these methods in healthcare organizations interested in advancing health information technology.
Full Text Available While much is new and exciting, many of the changes that seem so profound are actually superficial. The principles of economics and wealth creation endure. However, the new business climate has undermined traditional management practices and it has made the economic management techniques of information technology more relevant than ever before. The bad or lack use of the information nowadays to know all happened, is happening and will happen in a future can drive you to bankrupts. That is why, in the Information Society, how it’s called, all you Information Technology have to work in function to manage all the information that is important for you organization to know all about your environment. The use of the Information technology is very important to keep alive in this competitive business world. For a lot of managers all this is no more than a new “Buzzword”; but this business era has taught us that all them is wrong.
Eli, I; Schwartz-Arad, D; Bartal, Y
Stress significantly affects a person's cognitive ability to process information. Therefore, we hypothesized that patients' ability to recognize information related to the procedure they are about to undergo will be affected by the stressfulness of the situation (less recognition under a high-stress situation as compared with a low-stress situation). Patients (n = 66) were evaluated for their ability to recognize clinical information supplied on two different occasions: immediately before oral surgery (high-stress condition) and before suture removal (low-stress condition). Dental and state of anxiety and expectation of pain were also assessed. On both occasions, the patients' ability to recognize information correctly was low (less than 50%). Patients recognized significantly less information pre-operatively than before suture removal. State of anxiety, dental anxiety, and expectation to experience pain had a profound effect on their ability to recognize provided information correctly. Apparently, before dental treatment (high or low on stress), patients' ability to process information may be severely impaired.
Meoni, Paolo; Restani, Patrizia; Mancama, Dalu T
We conducted a survey of the National Centre for Biotechnology Information (NCBI) PubMed database to identify methods most commonly used for the evaluation of the effect of plant food supplements on the cardiovascular system and their relevance to the regulatory status of these products. Particularly, our search strategy was aimed at the selection of studies concerning the clinical evaluation of the beneficial effects of the most commonly studied plant food supplements acting on the cardiovascular system. Following the screening of 3839 papers for inclusion criteria, 48 published reports were retained for this review. Most studies included in this review used a double blind controlled design, and evaluated the effect of plant food supplements on individuals affected by a disease of the cardiovascular system. The majority of the studies were found to be of low methodological quality on the Jadad scale, mainly because of inadequate reporting of adverse events and of patient withdrawals. In comparison, measures used for the evaluation of benefits included mostly cardiovascular risk factors as recommended in international guidelines and in accordance with principles laid down for the evaluation of health claims in food. The risk factors most frequently evaluated belonged to the category of "lipid function and levels", "heart function" and "blood pressure". For the absolute majority of the studies, the study period did not exceed one month. This review highlights critical factors to be considered in the design of studies evaluating the health effects of plant food supplements on the cardiovascular system. Between others, the inclusion of healthy individuals, better reporting and description of the characteristics of the product used could improve the quality and relevance of these studies.
Ngan, Olivia Miu Yung; Yi, Huso; Wong, Samuel Yeung Shan; Sahota, Daljit; Ahmed, Shenaz
While non-invasive prenatal testing (NIPT) for fetal aneuploidy is commercially available in many countries, little is known about how obstetric professionals in non-Western populations perceive the clinical usefulness of NIPT in comparison with existing first-trimester combined screening (FTS) for Down syndrome (DS) or invasive prenatal diagnosis (IPD), or perceptions of their ethical concerns arising from the use of NIPT. A cross-sectional survey among 327 obstetric professionals (237 midwives, 90 obstetricians) in Hong Kong. Compared to FTS, NIPT was believed to: provide more psychological benefits and enable earlier consideration of termination of pregnancy. Compared to IPD, NIPT was believed to: provide less psychological stress for high-risk women and more psychological assurance for low-risk women, and offer an advantage to detect chromosomal abnormalities earlier. Significant differences in perceived clinical usefulness were found by profession and healthcare sector: (1) obstetricians reported more certain views towards the usefulness of NIPT than midwives and (2) professionals in the public sector perceived less usefulness of NIPT than the private sector. Beliefs about earlier detection of DS using NIPT were associated with ethical concerns about increasing abortion. Participants believing that NIPT provided psychological assurance among low-risk women were less likely to be concerned about ethical issues relating to informed decision-making and pre-test consultation for NIPT. Our findings suggest the need for political debate initially on how to ensure pregnant women accessing public services are informed about commercially available more advanced technology, but also on the potential implementation of NIPT within public services to improve access and equity to DS screening services.
Cao, Yong-gang; Cimino, James J; Ely, John; Yu, Hong
Clinicians pose complex clinical questions when seeing patients, and identifying the answers to those questions in a timely manner helps improve the quality of patient care. We report here on two natural language processing models, namely, automatic topic assignment and keyword identification, that together automatically and effectively extract information needs from ad hoc clinical questions. Our study is motivated in the context of developing the larger clinical question answering system AskHERMES (Help clinicians to Extract and aRrticulate Multimedia information for answering clinical quEstionS). We developed supervised machine-learning systems to automatically assign predefined general categories (e.g. etiology, procedure, and diagnosis) to a question. We also explored both supervised and unsupervised systems to automatically identify keywords that capture the main content of the question. We evaluated our systems on 4654 annotated clinical questions that were collected in practice. We achieved an F1 score of 76.0% for the task of general topic classification and 58.0% for keyword extraction. Our systems have been implemented into the larger question answering system AskHERMES. Our error analyses suggested that inconsistent annotation in our training data have hurt both question analysis tasks. Our systems, available at http://www.askhermes.org, can automatically extract information needs from both short (the number of word tokens questions (the number of word tokens >20), and from both well-structured and ill-formed questions. We speculate that the performance of general topic classification and keyword extraction can be further improved if consistently annotated data are made available. Copyright © 2010 Elsevier Inc. All rights reserved.
Fuhrer, M J; Grabois, M
As part of a mail survey of physiatrists' views of conducting research, respondents were queried regarding information sources that influenced their introducing a clinical innovation into their practices in the past two years. Complete information was obtained from 356 individuals. The reported practice innovations were categorized as follows: (a) evoked potentials (6% of respondents); (b) electrophysiologic diagnostic procedures other than evoked potentials (19%); (c) other diagnostic/assessment procedures (11%); (d) transcutaneous nerve stimulation (6%); (e) physical treatment procedures other than transcutaneous nerve stimulation (22%); (f) medication (5%); (g) psychologic or social intervention (4%); and (h) altered methods of service delivery (27%). Considered across all practice innovation categories, the average relative importance (in descending order) of the information sources was as follows: (1) discovery in the individual's own practice; (2) a meeting, lecture, or continuing education course; (3) a clinical coworker; (4) a write-up in the clinical literature; (5) the individual's own research; (6) a patient; (7) a write-up in the research literature; (8) a textbook; and (9) the representative of a drug firm or equipment manufacturer. Additional findings concern variables which distinguished a group of 43 individuals who reported introducing no innovation into their practices for the preceding two years, compared to the 356 individuals who did so.
Full Text Available society. Factors that have led to the mushrooming of informal settlements in developing countries, most particularly in Africa, are massive rural urban migration, poverty and unequal distribution of wealth, poor land delivery systems, political...
US Fish and Wildlife Service, Department of the Interior — Information regarding environmental contaminants and oil spills on breeding Atlantic Coast piping plovers (Charadrius melodus) was solicited from state and federal...
Meystre, Stéphane M; Ferrández, Óscar; Friedlin, F Jeffrey; South, Brett R; Shen, Shuying; Samore, Matthew H
As more and more electronic clinical information is becoming easier to access for secondary uses such as clinical research, approaches that enable faster and more collaborative research while protecting patient privacy and confidentiality are becoming more important. Clinical text de-identification offers such advantages but is typically a tedious manual process. Automated Natural Language Processing (NLP) methods can alleviate this process, but their impact on subsequent uses of the automatically de-identified clinical narratives has only barely been investigated. In the context of a larger project to develop and investigate automated text de-identification for Veterans Health Administration (VHA) clinical notes, we studied the impact of automated text de-identification on clinical information in a stepwise manner. Our approach started with a high-level assessment of clinical notes informativeness and formatting, and ended with a detailed study of the overlap of select clinical information types and Protected Health Information (PHI). To investigate the informativeness (i.e., document type information, select clinical data types, and interpretation or conclusion) of VHA clinical notes, we used five different existing text de-identification systems. The informativeness was only minimally altered by these systems while formatting was only modified by one system. To examine the impact of de-identification on clinical information extraction, we compared counts of SNOMED-CT concepts found by an open source information extraction application in the original (i.e., not de-identified) version of a corpus of VHA clinical notes, and in the same corpus after de-identification. Only about 1.2-3% less SNOMED-CT concepts were found in de-identified versions of our corpus, and many of these concepts were PHI that was erroneously identified as clinical information. To study this impact in more details and assess how generalizable our findings were, we examined the overlap between
Harris, C. M.; Scanlon, K. W.
The University of Pennsylvania Health System recently underwent an extensive selection process for a new clinical information system. In addition to a traditional system selection approach, a clinical case study was utilized during our selection process. This was done in an effort to better prepare the clinicians involved in the selection process, as well as to help identify key operational issues that the institution would need to resolve, related to the design and implementation of a new clinical system. We wil describe here the reasons this approach was chosen, how the case study was utilized, and provide an assessment of its usefulness. PMID:7950007
Patricia A. Abbott
Full Text Available Clinical environments are complex, stressful, and safety critical—heightening the demand for technological solutions that will help clinicians manage health information efficiently and safely. The industry has responded by creating numerous, increasingly compact and powerful health IT devices that fit in a pocket, hook to a belt, attach to eyeglasses, or wheel around on a cart. Untethering a provider from a physical “place” with compact, mobile technology while delivering the right information at the right time and at the right location are generally welcomed in clinical environments. These developments however, must be looked at ecumenically. The cognitive load of clinicians who are occupied with managing or operating several different devices during the process of a patient encounter is increased, and we know from decades of research that cognitive overload frequently leads to error. “Technology crowding,” enhanced by the plethora of mobile health IT, can actually become an additional millstone for busy clinicians. This study was designed to gain a deeper understanding of clinicians’ interactions with a mobile clinical computing appliance (Motion Computing C5 designed to consolidate numerous technological functions into an all-in-one device. Features of usability and comparisons to current methods of documentation and task performance were undertaken and results are described.
Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial.
Pinnock, Hilary; Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; Lewis, Stephanie; Stoddart, Andrew; van der Pol, Marjon; MacNee, William; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian
To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Researcher blind, multicentre, randomised controlled trial. UK primary care (Lothian, Scotland). Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems. Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services. The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George's respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat. Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person (standard deviation 1.9) v control 1.1 (1.6); P=0.59). Mean duration of COPD admissions over
Mncube-Barnes, Fatima M; Lee, Ben; Esuruoso, Olumuyiwa; Gona, Phil N; Daphnis, Stephane
Using library subscriptions and accessible on handheld devices, this study sought to promote authoritative health information apps, and evidence-based point-of-care resources. Three cohorts of internal medicine residents were issued iPads at the beginning of their second year, and were trained to skillfully access resources from the digital library. Pre- and post-intervention surveys were respectively administered at the beginning of the second year and end of the third year of training. The residents' computer experience and computer knowledge was assessed. Additionally, before and after formal introduction to iPads, perceptions on the use of computers to access clinical information were assessed. Survey responses were compared using two sample methods and summarized through descriptive statistics. Sixty-eight residents completed the pre-survey questionnaires and 45 completed the post-surveys. There were significant improvements in the residents' level of computer experience, and familiarity with medical apps. Furthermore, there was increased knowledge obtained in accessing clinical information through electronic medical records. Residents positively perceived the potential effects of computers and electronic medical records in medicine. Study findings suggested that health science libraries can be instrumental in providing search skills to health professionals, especially residents in training. Participants showed appreciation of iPads and library support that facilitated successful completion of their related tasks. Replicating this study with a larger sample derived from multiple sites is recommended for future studies. Participation of mid-level healthcare professionals, such as Physician Assistants and Nurse Practitioners is suggested.
Gresnigt, Marco M. M.; Kalk, Warner; Ozcan, Mutlu
This study evaluated the survival rate of ceramic laminate veneers bonded to teeth with and without existing composite restorations (ECR). Twenty patients (mean age: 49.7 years) received 92 feldspathic ceramic laminate veneers (Shofu Vintage AL) on the maxillary teeth (intact teeth: n = 26; teeth
Jeremy J Jay
Full Text Available Concise visualization is critical to present large amounts of information in a minimal space that can be interpreted quickly. Clinical applications in precision medicine present an important use case due to the time dependent nature of the interpretations, although visualization is increasingly necessary across the life sciences. In this paper we describe the Lollipops software for the presentation of panel or exome sequencing results. Source code and binaries are freely available at https://github.com/pbnjay/lollipops. Although other software and web resources exist to produce lollipop diagrams, these packages are less suited to clinical applications. The demands of precision medicine require the ability to easily fit into a workflow and incorporate external information without manual intervention.The Lollipops software provides a simple command line interface that only requires an official gene symbol and mutation list making it easily scriptable. External information is integrated using the publicly available Uniprot and Pfam resources. Heuristics are used to select the most informative components and condense them for a concise plot. The output is a flexible Scalable Vector Graphic (SVG diagram that can be displayed in a web page or graphic illustration tool.The Lollipops software creates information-dense, publication-quality mutation plots for automated pipelines and high-throughput workflows in precision medicine. The automatic data integration enables clinical data security, and visualization heuristics concisely present knowledge with minimal user configuration.
Kerr, P. L. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)
An SNM attribute Information Barrier (IB) system was developed for a 2011 US/UK Exercise. The system was modified and extensively tested in a 2013-2014 US-UK Measurement Campaign. This work demonstrated rapid deployment of an IB system for potential treaty use. The system utilizes an Ortec Fission Meter neutron multiplicity counter and custom computer code. The system demonstrates a proof-of-principle automated Pu-240 mass determination with an information barrier. After a software start command is issued, the system automatically acquires and downloads data, performs an analysis, and displays the results. This system conveys the results of a Pu mass threshold measurements in a way the does not reveal sensitive information. In full IB mode, only red/green ‘lights’ are displayed in the software. In test mode, more detailed information is displayed. The code can also read in, analyze, and display results from previously acquired or simulated data. Because the equipment is commercial-off-the-shelf (COTS), the system demonstrates a low-cost short-lead-time technology for treaty SNM attribute measurements. A deployed system will likely require integration of additional authentication and tamper-indicating technologies. This will be discussed for the project in this and future progress reports.
Babel, Lucie; Vannametee, Ekkamol; Hendriks, Martin; Schuur, Jasper; de Jong, Steven; Bierkens, Marinus; Karssenberg, Derek
Geomorphological maps are valuable tools for studying land surfaceprocesses. Information obtained from the field geomorphological maps canbe, in turn, used in mapping geomorphology at another area. In thisstudy, we present an application of the multiple-point geostatistics(MPG) technique in
McKinney, Ross E.; Beskow, Laura M.; Ford, Daniel E.; Lantos, John D.; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J.; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin
There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to IRBs as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients’ rights and interests. PMID:26374677
In Young Choi
Full Text Available The advances in electronic medical records (EMRs and bioinformatics (BI represent two significant trends in healthcare. The widespread adoption of EMR systems and the completion of the Human Genome Project developed the technologies for data acquisition, analysis, and visualization in two different domains. The massive amount of data from both clinical and biology domains is expected to provide personalized, preventive, and predictive healthcare services in the near future. The integrated use of EMR and BI data needs to consider four key informatics areas: data modeling, analytics, standardization, and privacy. Bioclinical data warehouses integrating heterogeneous patient-related clinical or omics data should be considered. The representative standardization effort by the Clinical Bioinformatics Ontology (CBO aims to provide uniquely identified concepts to include molecular pathology terminologies. Since individual genome data are easily used to predict current and future health status, different safeguards to ensure confidentiality should be considered. In this paper, we focused on the informatics aspects of integrating the EMR community and BI community by identifying opportunities, challenges, and approaches to provide the best possible care service for our patients and the population.
Maxwell, O.J.R.; Miguel-Pacheco, G.G.; Newsome, R.; Randall, L. V.; Remnant, J.G.; Thomas, H J; Huxley, J.N.
Lameness in cattle has significant consequences for welfare, health and productivity. More research is now being done on lameness and this article, the first in a two-part series, provides an update on research-based advances in the field published from around the world over the past five years. These developments have improved our understanding of lameness in cattle and can inform clinical practice and the control of lameness on-farm. The second article, to be published in a subsequent issue...
Chu, S C; Thom, J B
A clinical information system (CIS) prototype was created from an Object-Oriented (OO) design. We experienced considerable difficulties when implementing the OO data model in a relational database management system (RDBMS), including lack of semantic power and support for complex objects, inability to encapsulate object methods, and performance degradation due to extensive join operations. This paper reflects on the experiences of a CIS research project and explores issues related to the use of RDBMS and Object-Oriented Database Management Systems (OODBMS) in CIS design and development.
Physician adoption of clinical information technology is important for its successful implementation. Therefore, the purpose of this study is to gain a better insight about factors affecting physicians’ acceptance of clinical decision support systems (CDSS in a hospital setting. The results reflect the importance of perceived threat to professional autonomy, perceived interactivity with clinical IT, perceived usefulness and perceived ease of use in determining physicians’ intention to use CDSS.
Full Text Available Abstract In this paper we are using the existing passcode based approach of hiding classified information in images with addition of the Galois field theorywhich is advancing the security level to make this combination method extremely difficult to intercept and useful for open channel communication while maintaining the losses and high speed transmission.
Attarbaschi, Andishe; Carraro, Elisa; Abla, Oussama; Barzilai-Birenboim, Shlomit; Bomken, Simon; Brugieres, Laurence; Bubanska, Eva; Burkhardt, Birgit; Chiang, Alan K S; Csoka, Monika; Fedorova, Alina; Jazbec, Janez; Kabickova, Edita; Krenova, Zdenka; Lazic, Jelena; Loeffen, Jan; Mann, Georg; Niggli, Felix; Miakova, Natalia; Osumi, Tomoo; Ronceray, Leila; Uyttebroeck, Anne; Williams, Denise; Woessmann, Wilhelm; Wrobel, Grazyna; Pillon, Marta
Children and adolescents with pre-existing conditions such as DNA repair defects or other primary immunodeficiencies have an increased risk of non-Hodgkin lymphoma. However, large-scale data on patients with non-Hodgkin lymphoma and their entire spectrum of pre-existing conditions are scarce. A retrospective multinational study was conducted by means of questionnaires sent out to the national study groups or centers, by the two largest consortia in childhood non-Hodgkin lymphoma, the European Intergroup for Childhood non-Hodgkin Lymphoma, and the international Berlin-Frankfurt-Münster Study Group. The study identified 213 patients with non-Hodgkin lymphoma and a pre-existing condition. Four subcategories were established: a) cancer predisposition syndromes (n=124, 58%); b) primary immunodeficiencies not further specified (n=27, 13%); c) genetic diseases with no increased cancer risk (n=40, 19%); and d) non-classifiable conditions (n=22, 10%). Seventy-nine of 124 (64%) cancer predispositions were reported in groups with more than 20 patients: ataxia telangiectasia (n=32), Nijmegen breakage syndrome (n=26), constitutional mismatch repair deficiency (n=21). For the 151 patients with a known cancer risk, 5-year event-free survival and overall survival rates were 40%±4% and 51%±4%, respectively. Five-year cumulative incidences of progression/relapse and treatment-related death as a first event were 22%±4% and 24%±4%, respectively. Ten-year incidence of second malignancy was 24%±5% and 7-year overall survival of the 21 patients with a second malignancy was 41%±11%. Patients with non-Hodgkin lymphoma and pre-existing conditions have an inferior survival rate with a large proportion of therapy-related deaths compared to patients with non-Hodgkin lymphoma and no pre-existing conditions. They may require special vigilance when receiving standard or modified/reduced-intensity chemotherapy or when undergoing allogeneic stem cell transplantation. Copyright© Ferrata
Watt, Stuart; Jiao, Wei; Brown, Andrew M K; Petrocelli, Teresa; Tran, Ben; Zhang, Tong; McPherson, John D; Kamel-Reid, Suzanne; Bedard, Philippe L; Onetto, Nicole; Hudson, Thomas J; Dancey, Janet; Siu, Lillian L; Stein, Lincoln; Ferretti, Vincent
Using sequencing information to guide clinical decision-making requires coordination of a diverse set of people and activities. In clinical genomics, the process typically includes sample acquisition, template preparation, genome data generation, analysis to identify and confirm variant alleles, interpretation of clinical significance, and reporting to clinicians. We describe a software application developed within a clinical genomics study, to support this entire process. The software application tracks patients, samples, genomic results, decisions and reports across the cohort, monitors progress and sends reminders, and works alongside an electronic data capture system for the trial's clinical and genomic data. It incorporates systems to read, store, analyze and consolidate sequencing results from multiple technologies, and provides a curated knowledge base of tumor mutation frequency (from the COSMIC database) annotated with clinical significance and drug sensitivity to generate reports for clinicians. By supporting the entire process, the application provides deep support for clinical decision making, enabling the generation of relevant guidance in reports for verification by an expert panel prior to forwarding to the treating physician. Copyright © 2013 Elsevier Inc. All rights reserved.
Hsieh, Nan-Chen; Chang, Chung-Yi; Lee, Kuo-Chen; Chen, Jeen-Chen; Chan, Chien-Hui
Recent studies have shown that computerized clinical case management and decision support systems can be used to assist surgeons in the diagnosis of disease, optimize surgical operation, aid in drug therapy and decrease the cost of medical treatment. Therefore, medical informatics has become an extensive field of research and many of these approaches have demonstrated potential value for improving medical quality. The aim of this study was to develop a web-based cardiovascular clinical information system (CIS) based on innovative techniques, such as electronic medical records, electronic registries and automatic feature surveillance schemes, to provide effective tools and support for clinical care, decision-making, biomedical research and training activities. The CIS developed for this study contained monitoring, surveillance and model construction functions. The monitoring layer function provided a visual user interface. At the surveillance and model construction layers, we explored the application of model construction and intelligent prognosis to aid in making preoperative and postoperative predictions. With the use of the CIS, surgeons can provide reasonable conclusions and explanations in uncertain environments.
Wyres, Kelly L; Conway, Thomas C; Garg, Saurabh; Queiroz, Carlos; Reumann, Matthias; Holt, Kathryn; Rusu, Laura I
Recent advances in DNA sequencing technologies have the potential to transform the field of clinical and public health microbiology, and in the last few years numerous case studies have demonstrated successful applications in this context. Among other considerations, a lack of user-friendly data analysis and interpretation tools has been frequently cited as a major barrier to routine use of these techniques. Here we consider the requirements of microbiology laboratories for the analysis, clinical interpretation and management of bacterial whole-genome sequence (WGS) data. Then we discuss relevant, existing WGS analysis tools. We highlight many essential and useful features that are represented among existing tools, but find that no single tool fulfils all of the necessary requirements. We conclude that to fully realise the potential of WGS analyses for clinical and public health microbiology laboratories of all scales, we will need to develop tools specifically with the needs of these laboratories in mind.
Taber, Celia; Warren, Jim; Day, Karen
The clinical research industry has yet to fully embrace information technology (IT) for informed consent purposes, even though it is used indispensably in our everyday lives and in other areas of clinical research and healthcare. This paper presents findings of a meta-narrative literature review to discuss the potential for IT to improve the quality of clinical research informed consent. The review reveals three main rationales for including IT in research consent. First, in the current context consent documents frequently fail to be effective decision aids for patients, and the lack of patient centricity in the process. Second, social media provides opportunities for patients to consult with a broader community during research consent to seek broader support, and potential to participate in creating a more patient centric process. Third, multimedia tools provide opportunities for improved patient education, engagement and decision making during research consent. IT offers opportunities to achieve more meaningful research consent, but more research is needed to create an evidence base, policies and economic analyses on the return on investment of using IT in the process.
Conclusion: PESS index is complex and different from all other indexes already present in the literature. It permits to evaluate not only the status of periapical tissues, but also endodontic treatment quality. Furthermore, the COPI periapical index has prognostic value due to its suggested AP treatment risk degrees. PESS can be used in epidemiological studies and clinical practice. Future research must validate it. Finally, if universally adopted, this system of evaluation might allow groups worldwide to calibrate and build powerful combined data.
Aganovic, Amar; Hamon, Mathieu; Kolarik, Jakub
Mechanical ventilation has become a mandatory requirement in multiple European standards addressing indoor air quality (IAQ) and ventilation in residential dwellings (single family houses and low-rise apartment buildings). This article presents the state of the art study through a review of the e......Mechanical ventilation has become a mandatory requirement in multiple European standards addressing indoor air quality (IAQ) and ventilation in residential dwellings (single family houses and low-rise apartment buildings). This article presents the state of the art study through a review...... concentrations. The authors additionally noted that the literature frequently reported the role of improper maintenance and use on deterioration of IAQ in residential dwellings. The summarized data and comments may provide useful information for future guidelines related to ventilation strategies designed...
Babel, Lucie; Vannametee, Ekkamol; Hendriks, Martin; Schuur, Jasper; de Jong, Steven; Bierkens, Marc; Karssenberg, Derek
Geomorphological maps are valuable tools for studying land surface processes. Information obtained from the field geomorphological maps can be, in turn, used in mapping geomorphology at another area. In this study, we present an application of the multiple-point geostatistics (MPG) technique in geomorphological mapping. This technique makes use of the field geomorphological maps, together with the topographical data obtained from the Digital Elevation Model (DEM), to derive the knowledge on the formation of different geomorphological units in the landscape (e.g. river terrace, alluvial fan, badlands) as a basis in mapping areas with unknown geomorphology. This approach starts from characterizing the occurrence of each geomorphological class as a function of land surface attributes (i.e. attribute pattern), which consists of DEM derivatives discretized into classes (e.g. slope class) observed at that cell location, and geomorphology at multiple neighboring locations. The latter gives information on the spatial relation between geomorphological units. Number of cell occurrences per geomorphological class per attribute pattern is counted and stored in the frequency database, which will be subsequently used in the mapping. In the mapping stage, the algorithm assigns a realization of a geomorphological class to the target mapping cell, based on the probability function of geomorphological occurrences conditioned to the observed attribute pattern at the target mapping cell, as retrieved from the frequency database. The approach is tested to map the geomorphology in the 280 km2 Buëch catchment, French Alps. We use 4 morphometric attributes, extracted from a 37.5-m DEM resolution (i.e. height above the nearest drainage, slope gradient, profile curvature, and slope variability); and 2 non-morphometric attributes (i.e. geomorphology observed at 1-cell and 10-cells downstream from a cell of interest). Mapping is done using different frequency databases created from different
Full Text Available Abstract Background Computerized diagnostic information offers potential for epidemiological research; however data accuracy must be addressed. The principal aim of this study was to evaluate the completeness and correctness of diagnostic information in a computerized equine clinical database compared to corresponding hand written veterinary clinical records, used as gold standard, and to assess factors related to correctness. Further, the aim was to investigate completeness (epidemiologic sensitivity, correctness (positive predictive value, specificity and prevalence for diagnoses for four body systems and correctness for affected limb information for four joint diseases. Methods A random sample of 450 visits over the year 2002 (nvisits = 49,591 was taken from 18 nation wide clinics headed under one company. Computerized information for the visits selected and copies of the corresponding veterinary clinical records were retrieved. Completeness and correctness were determined using semi-subjective criteria. Logistic regression was used to examine factors associated with correctness for diagnosis. Results Three hundred and ninety six visits had veterinary clinical notes that were retrievable. The overall completeness and correctness were 91% and 92%, respectively; both values considered high. Descriptive analyses showed significantly higher degree of correctness for first visits compared to follow up visits and for cases with a diagnostic code recorded in the veterinary records compared to those with no code noted. The correctness was similar regardless of usage category (leisure/sport horse, racing trotter and racing thoroughbred or gender. For the four body systems selected (joints, skin and hooves, respiratory, skeletal the completeness varied between 71% (respiration and 91% (joints and the correctness ranged from 87% (skin and hooves to 96% (respiration, whereas the specificity was >95% for all systems. Logistic regression showed that
Penell, Johanna C; Bonnett, Brenda N; Pringle, John; Egenvall, Agneta
Computerized diagnostic information offers potential for epidemiological research; however data accuracy must be addressed. The principal aim of this study was to evaluate the completeness and correctness of diagnostic information in a computerized equine clinical database compared to corresponding hand written veterinary clinical records, used as gold standard, and to assess factors related to correctness. Further, the aim was to investigate completeness (epidemiologic sensitivity), correctness (positive predictive value), specificity and prevalence for diagnoses for four body systems and correctness for affected limb information for four joint diseases. A random sample of 450 visits over the year 2002 (nvisits=49,591) was taken from 18 nation wide clinics headed under one company. Computerized information for the visits selected and copies of the corresponding veterinary clinical records were retrieved. Completeness and correctness were determined using semi-subjective criteria. Logistic regression was used to examine factors associated with correctness for diagnosis. Three hundred and ninety six visits had veterinary clinical notes that were retrievable. The overall completeness and correctness were 91% and 92%, respectively; both values considered high. Descriptive analyses showed significantly higher degree of correctness for first visits compared to follow up visits and for cases with a diagnostic code recorded in the veterinary records compared to those with no code noted. The correctness was similar regardless of usage category (leisure/sport horse, racing trotter and racing thoroughbred) or gender.For the four body systems selected (joints, skin and hooves, respiratory, skeletal) the completeness varied between 71% (respiration) and 91% (joints) and the correctness ranged from 87% (skin and hooves) to 96% (respiration), whereas the specificity was >95% for all systems. Logistic regression showed that correctness was associated with type of visit, whether
Bagagiolo, Donatella; Didio, Alessia; Sbarbaro, Marco; Priolo, Claudio Giuseppe; Borro, Tiziana; Farina, Daniele
Osteopathic medicine is a form of complementary and alternative medicine. Osteopathic practitioners treat patients of all ages: according to the Osteopathic International Alliance's 2012 survey, about one-third of all treated patients are aged between 31 and 50 years and nearly a quarter (23.4%) are pediatric patients, with 8.7% of them being younger than 2 years. In 2013 a systematic review evaluated the effectiveness of osteopathic manipulative treatment (OMT) in pediatric patients with different underlying disorders, but due to the paucity and low methodological quality of the primary studies the results were inconclusive. The aim of this review is therefore to update the evidence concerning OMT in perinatal and pediatric disorders and to assess its clinical impact. Most published studies favor OMT, but the generally small sample sizes in these studies cannot support ultimate conclusions about the efficacy of osteopathic therapy in pediatric age. In turn, clinical trials of OMT in premature infants might represent an important step in the osteopathic research because they can address both cost-effectiveness issues, and an innovative, multidisciplinary approach to the management of specific pediatric diseases cared for by the same, common health care system. The available studies in neonatal settings provide evidence that OMT is effective in reducing the hospital length of stay of the treated infants, therefore, suggesting that robust cost-effectiveness analyses should be included in the future clinical trials' design to establish new possible OMT-shared strategies within the health care services provided to newborns. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
Kortüm, K U; Müller, M; Babenko, A; Kampik, A; Kreutzer, T C
In times of increased digitalization in healthcare, departments of ophthalmology are faced with the challenge of introducing electronic clinical health records (EHR); however, specialized software for ophthalmology is not available with most major EHR sytems. The aim of this project was to create specific ophthalmological user interfaces for large inpatient eye care providers within a hospitalwide EHR. Additionally the integration of ophthalmic imaging systems, scheduling and surgical documentation should be achieved. The existing EHR i.s.h.med (Siemens, Germany) was modified using advanced business application programming (ABAP) language to create specific ophthalmological user interfaces for reproduction and moreover optimization of the clinical workflow. A user interface for documentation of ambulatory patients with eight tabs was designed. From June 2013 to October 2014 a total of 61,551 patient contact details were documented. For surgical documentation a separate user interface was set up. Digital clinical orders for documentation of registration and scheduling of operations user interfaces were also set up. A direct integration of ophthalmic imaging modalities could be established. An ophthalmologist-orientated EHR for outpatient and surgical documentation for inpatient clinics was created and successfully implemented. By incorporation of imaging procedures the foundation of future smart/big data analyses was created.
Du, Qinghe; Zhao, Weidong; Li, Weimin; Zhang, Xuelin; Sun, Bo; Song, Houbing; Ren, Pinyi; Sun, Li; Wang, Yichen
The prosperity of e-health is boosted by fast development of medical devices with wireless communications capability such as wearable devices, tiny sensors, monitoring equipments, etc., which are randomly distributed in clinic environments. The drastically-increasing population of such devices imposes new challenges on the limited wireless resources. To relieve this problem, key knowledge needs to be extracted from massive connection attempts dispersed in the air towards efficient access control. In this paper, a hybrid periodic-random massive access (HPRMA) scheme for wireless clinical networks employing ultra-narrow band (UNB) techniques is proposed. In particular, the proposed scheme towards accommodating a large population of devices include the following new features. On one hand, it can dynamically adjust the resource allocated for coexisting periodic and random services based on the traffic load learned from signal collision status. On the other hand, the resource allocation within periodic services is thoroughly designed to simultaneously align with the timing requests of differentiated services. Abundant simulation results are also presented to demonstrate the superiority of the proposed HPRMA scheme over baseline schemes including time-division multiple access (TDMA) and random access approach, in terms of channel utilization efficiency, packet drop ratio, etc., for the support of massive devices' services.
Malik, Laeeq; Kuo, James; Yip, Desmond; Mejia, Alex
The purpose of this study was to analyze the content of informed consent forms for clinical trials in medical oncology to assess readability, determine their completeness, and identify any shortcomings. Informed consent forms for Phase I-III studies that were conducted at two tertiary care cancer centers over a 3-year period were reviewed. Information pertaining to length of the informed consent form, research regimen/methods, treatment agent, potential risks, and benefits was extracted. The reading level was assessed by Flesch-Kincaid and Gunning-Fog index readability tests. All of the 112 informed consent forms clearly stated the voluntary nature of participation. Nearly one half of the forms (51.8%) were of Phase I studies. The median length of informed consent form was 20 pages (range: 8-28). A detailed estimation of the frequency or intensity of risks (range: 3-8 pages) was provided. The average reading level of the informed consent forms was high (Flesch-Kincaid Grade Level of 9.8), which corresponds roughly to 10th-grade reading level. Less than 15% of all consent forms were written at the recommended eighth-grade reading level. A substantial number of forms did not report a potential risk to pregnant/lactating women (16.9%), mechanism of action of the investigational agent (34.8%), study schema (77.6%), a possibility of receiving sub-therapeutic dose (37%), or death (12.5%). Nearly one half of the forms (49.1%) stated clearly that individual participants may not benefit. Overall, these informed consent forms provided a detailed description of the trials in accordance to international guidelines. However, there remains room for improvement, particularly in areas of readability and document length. © The Author(s) 2014.
Førde, R; Vandvik, I H
To summarise the types of case brought to the Clinical Ethics Committee of the National Hospital of Norway from 1996 to 2002 and to describe and discuss to what extent issues of information/communication have been involved in the ethical problems. Systematic review of case reports. Of the 31 case discussions, (20 prospective, 11 retrospective), 19 cases concerned treatment of children. Twenty cases concerned ethical problems related to withholding/withdrawing of treatment. In 25 cases aspects of information/communication were involved in the ethical problem, either explicitly (n = 3) or implicitly (n = 22). Problems related to information/communication may underlie a classic ethical problem. Identification of these "hidden" problems may be important for the analysis, and hence, the solution to the ethical dilemma.
Moreno-Conde, Alberto; Moner, David; Cruz, Wellington Dimas da; Santos, Marcelo R; Maldonado, José Alberto; Robles, Montserrat; Kalra, Dipak
This systematic review aims to identify and compare the existing processes and methodologies that have been published in the literature for defining clinical information models (CIMs) that support the semantic interoperability of electronic health record (EHR) systems. Following the preferred reporting items for systematic reviews and meta-analyses systematic review methodology, the authors reviewed published papers between 2000 and 2013 that covered that semantic interoperability of EHRs, found by searching the PubMed, IEEE Xplore, and ScienceDirect databases. Additionally, after selection of a final group of articles, an inductive content analysis was done to summarize the steps and methodologies followed in order to build CIMs described in those articles. Three hundred and seventy-eight articles were screened and thirty six were selected for full review. The articles selected for full review were analyzed to extract relevant information for the analysis and characterized according to the steps the authors had followed for clinical information modeling. Most of the reviewed papers lack a detailed description of the modeling methodologies used to create CIMs. A representative example is the lack of description related to the definition of terminology bindings and the publication of the generated models. However, this systematic review confirms that most clinical information modeling activities follow very similar steps for the definition of CIMs. Having a robust and shared methodology could improve their correctness, reliability, and quality. Independently of implementation technologies and standards, it is possible to find common patterns in methods for developing CIMs, suggesting the viability of defining a unified good practice methodology to be used by any clinical information modeler. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: firstname.lastname@example.org.
Wang, Yan; Chen, Elizabeth S; Pakhomov, Serguei; Arsoniadis, Elliot; Carter, Elizabeth W; Lindemann, Elizabeth; Sarkar, Indra Neil; Melton, Genevieve B
Within clinical discourse, social history (SH) includes important information about substance use (alcohol, drug, and nicotine use) as key risk factors for disease, disability, and mortality. In this study, we developed and evaluated a natural language processing (NLP) system for automated detection of substance use statements and extraction of substance use attributes (e.g., temporal and status) based on Stanford Typed Dependencies. The developed NLP system leveraged linguistic resources and domain knowledge from a multi-site social history study, Propbank and the MiPACQ corpus. The system attained F-scores of 89.8, 84.6 and 89.4 respectively for alcohol, drug, and nicotine use statement detection, as well as average F-scores of 82.1, 90.3, 80.8, 88.7, 96.6, and 74.5 respectively for extraction of attributes. Our results suggest that NLP systems can achieve good performance when augmented with linguistic resources and domain knowledge when applied to a wide breadth of substance use free text clinical notes.
Boros, Adam Kenneth
The article outlines the findings of a study designed to explore the working relationship between home-based caregivers and clinic nurses at locations in two informal settlements in Johannesburg, South Africa. By considering the views and experiences of both sponsored and unsponsored caregivers, the research focused on how degrees of informality affect this relationship. The nurse/caregiver relationship represents a primary interface between the formal and informal health sectors and is an important part of the country's primary healthcare system. Despite the attention given to linking home-based care (HBC) with the formal health system, very little research has examined the functionality of this link at the ground level. Through a number of qualitative, semi-structured interviews with nurses, home-based caregivers, and staff from the Department of Health, information was collected to better understand what systems are in place to facilitate the relationship between clinics and HBC organisations, and whether these systems are helping to create the desired results. Do the formal and informal health sectors complement and strengthen or do they distract and damage each other? By examining the influence of degrees of informality, the research also lends insight into how this distinction plays a role in healthcare provision. For instance, how does state support impact the link between the formal and informal health sectors and the ultimate quality of care? And what steps can be taken to improve the health system in this regard, as a whole? The findings point to a number of problems and challenges with integrating HBC into the formal health sector. Degrees of informality are found to have a profound impact on the work of home-based caregivers in some respects, but a surprising lack of impact in others. These issues need to be confronted in order to improve the existing system and, ultimately, health outcomes in South Africa.
Kang, Tian; Zhang, Shaodian; Tang, Youlan; Hruby, Gregory W; Rusanov, Alexander; Elhadad, Noémie; Weng, Chunhua
To develop an open-source information extraction system called Eligibility Criteria Information Extraction (EliIE) for parsing and formalizing free-text clinical research eligibility criteria (EC) following Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) version 5.0. EliIE parses EC in 4 steps: (1) clinical entity and attribute recognition, (2) negation detection, (3) relation extraction, and (4) concept normalization and output structuring. Informaticians and domain experts were recruited to design an annotation guideline and generate a training corpus of annotated EC for 230 Alzheimer's clinical trials, which were represented as queries against the OMOP CDM and included 8008 entities, 3550 attributes, and 3529 relations. A sequence labeling-based method was developed for automatic entity and attribute recognition. Negation detection was supported by NegEx and a set of predefined rules. Relation extraction was achieved by a support vector machine classifier. We further performed terminology-based concept normalization and output structuring. In task-specific evaluations, the best F1 score for entity recognition was 0.79, and for relation extraction was 0.89. The accuracy of negation detection was 0.94. The overall accuracy for query formalization was 0.71 in an end-to-end evaluation. This study presents EliIE, an OMOP CDM-based information extraction system for automatic structuring and formalization of free-text EC. According to our evaluation, machine learning-based EliIE outperforms existing systems and shows promise to improve.
Marks, R G; Conlon, M; Ruberg, S J
The use of the world wide web for clinical trials changes the processes of performing clinical research in several fundamental ways. Greatly improved security, monitoring capability, and accuracy and timeliness of study conduct can be achieved while lowering cost. Data quality is enhanced while co-ordinating centre effort is reduced. The web provides a natural environment for linking the various components of clinical research, leading to new levels of simplicity and efficiency. It also enhances opportunities for recruitment of study investigators and patients. Other information technology tools and databases can be used to assist in this regard as well. Web-based trials change the relationship of the investigator site to the study and the site to the co-ordinating centre. Different roles and responsibilities lead to simplified processes and more and higher quality data. Many standard co-ordinating centre activities, such as randomization, protocol implementation and amending, document tracking, adverse event reporting, site monitoring, report generation and data analysis are all fundamentally changed in a web-based trial. Opportunities are enhanced to identify potential investigators and support their successful study conduct. As the role of investigator sites is changed in web-based research, more primary care medical providers can be attracted to research, providing more typical patients to studies than those sometimes available through more traditional research sites, especially those at academic study sites. Other activities can now be co-ordinated electronically with the advent of the web. The Institutional Review Board (IRB) can use online tools to control investigator participation, resulting in improved study efficiency and patient safety. A web-based research pharmacy provides tremendous efficiencies in managing and distributing study medications. Financial payments to the sites can be performed and recorded electronically, or even administered based on
Ngan, Olivia Miu Yung; Yi, Huso; Wong, Samuel Yeung Shan; Sahota, Daljit; Ahmed, Shenaz
Background While non-invasive prenatal testing (NIPT) for fetal aneuploidy is commercially available in many countries, little is known about how obstetric professionals in non-Western populations perceive the clinical usefulness of NIPT in comparison with existing first-trimester combined screening (FTS) for Down syndrome (DS) or invasive prenatal diagnosis (IPD), or perceptions of their ethical concerns arising from the use of NIPT. Methods A cross-sectional survey among 327 obstetric profe...
The rapid movement of information technologies into health care organizations has raised managerial concern regarding the capability of today's institutions to satisfactorily manage their introduction. Indeed, several health care institutions have consumed huge amounts of money and frustrated countless people in wasted information systems implementation efforts. Unfortunately, there are no easy answers as to why so many health informatics projects are not more successful. The aim of this study is to provide a deeper understanding of clinical information systems implementation. The research reported in this paper focuses on building a theory of the dynamic nature of the implementation process, that is, the how and why of what happened. The general approach taken was inspired by the work of Eisenhardt (1989) on building theories from case study research. We examined the implementation process, use and consequences of three distinct clinical information systems at a large tertiary care teaching hospital. A series of four research propositions reflecting the dynamic nature of the implementation process are offered as each of the three cases are analyzed. Findings add a number of new perspectives and empirical insights to the existing body of knowledge in the fields of IT implementation and medical informatics.
Jeddi, Fatemeh Rangraz; Hajbaghery, Mohsen Adib; Akbari, Hossein; Esmaili, Soheila
A successful implementation of an information system is impossible without sufficient knowledge of available technical resources of an institute. The aim of this study was to determine technical feasibility of a nursing clinical information system (NCIS) in Mazandaran province, Iran, 2015. This cross-sectional study was conducted in three steps. In the first step, a data gathering tool was developed through an unsystematic literature review. In the second step, a questionnaire was developed and validity of the tool was confirmed by receiving opinions of faculty members and calculating indices of Content Validity Index (CVI) and Content Validity Ratio (CVR). The questionnaire reliability was confirmed by calculating Cronbach's alpha coefficient (α= 0.72). In the third step, the feasibility of implementation of NCIS was evaluated by forming a panel of IT experts (n= 30), and through a questionnaire. Data were collected by 5-point Likert scale, very low to very high (scoring 1-5). Scores of each item were calculated and score percentage was determined. Chi-square and Fisher Exact tests were used. Maximum possibility of implementing NCIS were in the hardware area, additional equipment (92.6%), in the area of software, financial software (99.4%), in the area of network equipment, the possibility of integration with other internal systems, (92.6%) and in the area of network security, the possibility of backup version for security purposes (97.4%). Type of employment was statistically significant according to IT experts' opinions (p= 0.014). Hardware and software infrastructures for implementation of NCIS were desirable. The provision of more portable computers, advanced equipment such as barcode scanner, Radio-frequency identification (RFID), some approaches for increase accessibility of the system and essential databases from other resources and also increase of network lines' speed are necessary.
Full Text Available The technology acceptance model (TAM has been widely used to study user acceptance of new computer technologies. Previous studies claimed that future technology acceptance research should explore other additional explanatory variables, which may affect the originally proposed constructs of the TAM. The use of information technology in the health care sector and especially in hospitals offers great potential for improving the performance of physicians, increasing the quality of services and also reducing the organizational expenses. However, the main challenge that arises according to the literature is whether healthcare professionals are willing to adopt and use clinical information technology while performing their tasks. Although adoption of various information technologies has been studied using the technology acceptance model (TAM, the study of technology acceptance for professional groups (such as physicians has been limited. Physician adoption of clinical information technology is important for its successful implementation. Therefore, the purpose of this study is to gain a better insight about factors affecting physicians’ acceptance of clinical decision support systems (CDSS in a hospital setting. The results reflect the importance of perceived threat to professional autonomy, perceived interactivity with clinical IT, perceived usefulness and perceived ease of use in determining physicians’ intention to use CDSS.
their homes. These policy measures include building regulations, energy tax and different types of incentives and information dissemination. The conclusion calls for new and innovative policy measures to cope with the realities of renovations of owner-occupied houses and how energy efficiency improvement...
Song, Mei; Spallek, Heiko; Polk, Deborah; Schleyer, Titus; Wali, Teena
A major challenge in designing useful clinical information systems in dentistry is to incorporate clinical evidence based on dentists' information needs and then integrate the system seamlessly into the complex clinical workflow. However, little is known about the actual information needs of dentists during treatment sessions. The purpose of this study is to identify general dentists' information needs and the information sources they use to meet those needs in clinical settings so as to inform the design of dental information systems. A semi-structured interview was conducted with a convenience sample of 18 general dentists in the Pittsburgh area during clinical hours. One hundred and five patient cases were reported by these dentists. Interview transcripts were coded and analyzed using thematic analysis with a constant comparative method to identify categories and themes regarding information needs and information source use patterns. Two top-level categories of information needs were identified: foreground and background information needs. To meet these needs, dentists used four types of information sources: clinical information/tasks, administrative tasks, patient education and professional development. Major themes of dentists' unmet information needs include: (1) timely access to information on various subjects; (2) better visual representations of dental problems; (3) access to patient-specific evidence-based information; and (4) accurate, complete and consistent documentation of patient records. Resource use patterns include: (1) dentists' information needs matched information source use; (2) little use of electronic sources took place during treatment; (3) source use depended on the nature and complexity of the dental problems; and (4) dentists routinely practiced cross-referencing to verify patient information. Dentists have various information needs at the point of care. Among them, the needs for better visual representation and patient-specific evidence
A shortened Informed Consent Form, with information that a reasonable person would want to understand along with specific information that the person wants in particular would be a good option to improve understanding or comprehensibility. Additional informational meetings with a qualified person like a counselor could help in comprehension. Questionnaires designed to test comprehension of patient, peer review, patient writing the salient features could help evaluate the comprehensibility of the Informed Consent Form.
Johnson, Maree; Jefferies, Diana; Nicholls, Daniel
Clinical handover is the primary source of patient information for nurses; however, inadequate information transfer compromises patient safety. We investigated the content and organization of information conveyed at 81 handovers. A structure that captures and presents the information transferred at handover emerged: identification of the patient and clinical risks, clinical history/presentation, clinical status, care plan and outcomes/goals of care (ICCCO). This approach covers essential information while allowing for prioritization of information when required. Further research into the impact of ICCCO on patient safety is in progress. © 2012 Wiley Publishing Asia Pty Ltd.
Pechak, Celia M; Black, Jill D
Increasingly physical therapist students complete part of their clinical training outside of their home country. This trend is understudied. The purposes of this study were to: (1) explore, in depth, various international clinical education (ICE) programs; and (2) determine whether the Conceptual Model of Optimal International Service-Learning (ISL) could be applied or adapted to represent ICE. Qualitative content analysis was used to analyze ICE programs and consider modification of an existing ISL conceptual model for ICE. Fifteen faculty in the United States currently involved in ICE were interviewed. The interview transcriptions were systematically analyzed by two researchers. Three models of ICE practices emerged: (1) a traditional clinical education model where local clinical instructors (CIs) focus on the development of clinical skills; (2) a global health model where US-based CIs provide the supervision in the international setting, and learning outcomes emphasized global health and cultural competency; and (3) an ICE/ISL hybrid where US-based CIs supervise the students, and the foci includes community service. Additionally the data supported revising the ISL model's essential core conditions, components and consequence for ICE. The ICE conceptual model may provide a useful framework for future ICE program development and research.
Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities. Population health decision makers have indicated that waiting until FDA approval is often too late for the critical planning, budgeting, and forecasting associated with health benefit design, especially given the recent influx of high-cost medications and scrutiny for better evaluation and preparation. Recognizing that securities laws restrict the disclosure of nonpublic information and may need to be amended, permissible early dissemination would allow population health decision makers to incorporate clinical and economic information for pipeline drugs or expanded indications into financial forecasting for the following year's plan. Access to this information is needed 12-18 months before FDA approval when organizations are deciding on terms of coverage and budgetary assumptions for state health insurance rate filings, Medicare and Medicaid bids, contracts with health care purchasers, and other financial arrangements. The need for exchange of clinical economic information before FDA approval was first introduced at a previous Academy of Managed Care (AMCP) forum in March 2016, which addressed section 114 of the Food and Drug Administration Modernization Act and the communication of such information after FDA approval. To address preapproval information specifically, AMCP convened a Partnership Forum on September 13-14, 2016. This forum included a diverse group of stakeholders representing managed care, the biopharmaceutical industry, providers, patients
Full Text Available In this paper, we present a case study of a decision-support system deployment at The Alfred Hospital, in Melbourne, Australia. This work outlines Information and Communications Technology (ICT affordances and their actualisations in time-critical clinical practices to enable better information processing. From our study findings, we present a stage-wise model describing the role played by ICT in the context of the Trauma Centre practices. This addresses a knowledge gap surrounding the role and impact of ICT in the delivery of quality improvements to processes and culture in time-critical environments, amid increasing expenditure on ICT globally. Our model has implications for research and practice, such that we observe for the first time how information standards, synergy and renewal are developed between the system and its users in order to reduce error rates in the healthcare context. Through the study findings, we demonstrate that healthcare quality can be further refined as ICT allows for knowledge dissemination and informs existing practices.
Haun, Jolie N; Hathaway, Wendy; Chavez, Margeaux; Antinori, Nicole; Vetter, Brian; Miller, Brian K; Martin, Tracey L; Kendziora, Lisa; Nazi, Kim M; Melillo, Christine
Background Clinical care team members in Department of Veterans' Affairs (VA) facilities nationwide are working to integrate the use of Secure Messaging (SM) into care delivery and identify innovative uses. Identifying best practices for proactive use of SM is a key factor in its successful implementation and sustained use by VA clinical care team members and veterans. Objectives A collaborative project solicited input from VA clinical care teams about their local practices using SM to provide access to proactive patient-centered care for veterans and enhance workflow. Methods This project implemented a single-item cross-sectional qualitative electronic survey via internal e-mail to local coordinators in all 23 Veterans Integrated Service Networks (VISNs). Content analysis was used to manage descriptive data responses. Descriptive statistics described sample characteristics. Results VA clinical care team members across 15 of 23 VISNs responded to the questionnaire. Content analysis of 171 responses produced two global domains: (1) benefits of SM and (2) SM best practices. Benefits of SM use emphasize enhanced and efficient communication and increased access to care. Care team members incorporate SM into their daily clinical practices, using it to provide services before, during, and after clinical encounters as a best practice. SM users suggest improvements in veteran care, clinical team workflow, and efficient use of health resources. Clinical team members invested in the successful implementation of SM integrate SM into their daily practices to provide meaningful and useful veteran-centered care and improve workflow. Conclusion VA clinical care team members can use SM proactively to create an integrated SM culture. With adequate knowledge and motivation to proactively use this technology, all clinical team members within the VA system can replicate best practices shared by other clinical care teams to generate meaningful and useful interactions with SM
Parker, Carol; Weiner, Michael; Reeves, Mathew
To determine the use of health information exchange organizations (HIEs) to support and conduct clinical research. This scoping review included US-based studies published between January 2003 and March 2014 that used data from an HIE to address at least one of three categories of research: clinical or epidemiological research, financial evaluation, or utilization of health services. Eligibility was not restricted to research on HIEs. Studies with research questions outside of the evaluation of HIEs themselves were sought. Eighteen articles met final study inclusion criteria from an initial list of 847 hits. Fifteen studies addressed a clinical or epidemiological research question, 6 addressed a financial consideration, and 8 addressed a utilization issue. Considerable overlap was found among the research categories: 13 articles addressed more than one category. Of the eighteen included studies, only two used HIE data to answer a research objective that was NOT specific to HIE use. Research designs were varied and ranged from observational studies, such as cohort and cross-sectional studies, to randomized trials. The 18 articles represent the involvement of a small number of HIEs; 7 of the studies were from a single HIE. This review demonstrates that HIE-provided information is available and used to answer clinical or epidemiological, financial, or utilization-based research questions; however, the majority of the studies using HIE data are done with the primary goal of evaluating the use and impact of HIEs on health care delivery and outcomes. As HIEs mature and become integrated parts of the health care industry, the authors anticipate that fewer studies will be published that describe or validate the role of HIEs, and more will use HIEs as multi-institutional data sources for conducting clinical research and improving health services and clinical outcomes. Articles identified in this review indicate the limited extent that HIE data are being used for clinical
Edwards, Brian D; Bégaud, Bernard; Daemen, Esther; Dokas, Ioannis; Fishbein, Jonathan M; Greenberg, Howard E; Hochberg, Alan; Le Louet, Hervé; Lyngvig, Jytte; Mogles, Nataliya; Owen, Kathryn; Prendergast, Christine; Rejzek, Martin; Trantza, Sophia; Webb, David J; Whalen, Matthew; Whiteley, Simon
This is a joint statement from individual pharmacology and pharmaceutical professionals acting in their own capacity, including members of the Alliance for Clinical Research Excellence and Safety (ACRES) and the International Society of Pharmacovigilance (ISoP). By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur, starting with first-in-human clinical trials. To complement existing activities and regulations, we propose an additional approach blending evidence derived from both pharmacological and organizational science, which addresses human factors and transparency, to enhance organizational learning and continuous improvement. As happens with investigations in other sectors of society, such as the chemical and aviation sector, this systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future. We believe that repetition of potentially preventable and adverse outcomes during clinical research, by failing to identify and act upon all systematic vulnerabilities, is a situation that needs urgent change. As we will discuss further on, approaches based on applying systems theory and human factors are much more likely to improve objectivity and transparency, leading to better system design. © 2017 The British Pharmacological Society.
Full Text Available Recent advances in neuroimaging data acquisition and analysis hold the promise to enhance the ability to make diagnostic and prognostic predictions and perform treatment planning in neuropsychiatric disorders. Prior research using a variety of types of neuroimaging techniques has confirmed that neuropsychiatric disorders are associated with dysfunction in anatomical and functional brain circuits. We first discuss current challenges associated with the identification of reliable neuroimaging markers for diagnosis and prognosis in mood disorders and for neurosurgical treatment planning for deep brain stimulation (DBS. We then present data on the use of neuroimaging for the diagnosis and prognosis of mood disorders and for DBS treatment planning. We demonstrate how multivariate analyses of functional activation and connectivity parameters can be used to differentiate patients with bipolar disorder from those with major depressive disorder and non-affective psychosis. We also present data on connectivity parameters that mediate acute treatment response in affective and non-affective psychosis. We then focus on precision mapping of functional connectivity in native space. We describe the benefits of integrating anatomical fiber reconstruction with brain functional parameters and cortical surface measures to derive anatomically-informed connectivity metrics within the morphological context of each individual brain. We discuss how this approach may be particularly promising in psychiatry, given the clinical and etiological heterogeneity of the disorders, and particularly in treatment response prediction and planning. Precision mapping of connectivity is essential for DBS. In DBS, treatment electrodes are inserted into positions near key grey matter nodes within the circuits considered relevant to disease expression. However, targeting white matter tracts that underpin connectivity within these circuits may increase treatment efficacy and tolerability
The widespread adoption of Electronic Health Record (EHR) has resulted in rapid text proliferation within clinical care. Clinicians' use of copying and pasting functions in EHR systems further compounds this by creating a large amount of redundant clinical information in clinical documents. A mixture of redundant information (especially outdated…
Hackl, W O; Ganslandt, T
Objective: To summarize recent research and to propose a selection of best papers published in 2016 in the field of Clinical Information Systems (CIS). Method: The query used to retrieve the articles for the CIS section of the 2016 edition of the IMIA Yearbook of Medical Informatics was reused. It again aimed at identifying relevant publications in the field of CIS from PubMed and Web of Science and comprised search terms from the Medical Subject Headings (MeSH) catalog as well as additional free text search terms. The retrieved articles were categorized in a multi-pass review carried out by the two section editors. The final selection of candidate papers was then peer-reviewed by Yearbook editors and external reviewers. Based on the review results, the best papers were then chosen at the selection meeting with the IMIA Yearbook editorial board. Text mining, term co-occurrence mapping, and topic modelling techniques were used to get an overview on the content of the retrieved articles. Results: The query was carried out in mid-January 2017, yielding a consolidated result set of 2,190 articles published in 921 different journals. Out of them, 14 papers were nominated as candidate best papers and three of them were finally selected as the best papers of the CIS field. The content analysis of the articles revealed the broad spectrum of topics covered by CIS research. Conclusions: The CIS field is multi-dimensional and complex. It is hard to draw a well-defined outline between CIS and other domains or other sections of the IMIA Yearbook. The trends observed in the previous years are progressing. Clinical information systems are more than just sociotechnical systems for data collection, processing, exchange, presentation, and archiving. They are the backbone of a complex, trans-institutional information logistics process. Georg Thieme Verlag KG Stuttgart.
Abraham, Ivo L.
Studied the effects of general referral information about a client on subsequent clinical inferences. Nursing students (N=54) were randomly assigned to "referral information" or "no referral information" conditions before being presented with additional data. Clinical inferential tasks included the assessment of maladjustment, client stress,…
Cuggia, Marc; Garcelon, Nicolas; Campillo-Gimenez, Boris; Bernicot, Thomas; Laurent, Jean-François; Garin, Etienne; Happe, André; Duvauferrier, Régis
High amount of relevant information is contained in reports stored in the electronic patient records and associated metadata. R-oogle is a project aiming at developing information retrieval engines adapted to these reports and designed for clinicians. The system consists in a data warehouse (full-text reports and structured data) imported from two different hospital information systems. Information retrieval is performed using metadata-based semantic and full-text search methods (as Google). Applications may be biomarkers identification in a translational approach, search of specific cases, and constitution of cohorts, professional practice evaluation, and quality control assessment.
Full Text Available In view of the tremendous potential benefits of clinical information systems (CIS for the quality of patient care; it is hard to understand why not every CIS is embraced by its targeted users, the physicians. The aim of this study is to propose a framework for assessing hospital physicians' CIS-acceptance that can serve as a guidance for future research into this area. Hereto, a review of the relevant literature was performed in the ISI Web-of-Science database. Eleven studies were withheld from an initial dataset of 797 articles. Results show that just as in business settings, there are four core groups of variables that influence physicians' acceptance of a CIS: its usefulness and ease of use, social norms, and factors in the working environment that facilitate use of the CIS (such as providing computers/workstations, compatibility between the new and existing system.... We also identified some additional variables as predictors of CIS-acceptance.
Martínez-Costa, Catalina; Bosca, Diego; Legaz-García, Mari Carmen; Tao, Cui; Fernández Breis, Jesualdo Tomás; Schulz, Stefan; Chute, Christopher G
The generation of a semantic clinical infostructure requires linking ontologies, clinical models and terminologies . Here we describe an approach that would permit data coming from different sources and represented in different standards to be queried in a homogeneous and integrated way. Our assumption is that data providers should be able to agree and share the meaning of the data they want to exchange and to exploit. We will describe how Clinical Element Model (CEM) and OpenEHR datasets can be jointly exploited in Semantic Web environments.
A large proportion of the Nigerian populace patronize private health facilities, with the low level of the private sector involvement in the National Health Management information System significant health information remains unavailable. The private sector involvement needs to be enhanced with adequate training, supply of ...
Hughes, John; Greville-Harris, Maddy; Graham, Cynthia A; Lewith, George; White, Peter; Bishop, Felicity L
Patients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients' baseline (ie, pretrial recruitment) levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain. A 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience of receiving placebos. Participants recruited from community settings completed the study online. 210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly (SD=2.35). However, few participants correctly answered questions about the nocebo effect (31.9% correct) and the impact of the colour of a placebo pill (55.2% correct). The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Jones, Joseph L.; Haluska, Tana L.; Kresch, David L.
A method of updating flood inundation maps at a fraction of the expense of using traditional methods was piloted in Washington State as part of the U.S. Geological Survey Urban Geologic and Hydrologic Hazards Initiative. Large savings in expense may be achieved by building upon previous Flood Insurance Studies and automating the process of flood delineation with a Geographic Information System (GIS); increases in accuracy and detail result from the use of very-high-accuracy elevation data and automated delineation; and the resulting digital data sets contain valuable ancillary information such as flood depth, as well as greatly facilitating map storage and utility. The method consists of creating stage-discharge relations from the archived output of the existing hydraulic model, using these relations to create updated flood stages for recalculated flood discharges, and using a GIS to automate the map generation process. Many of the effective flood maps were created in the late 1970?s and early 1980?s, and suffer from a number of well recognized deficiencies such as out-of-date or inaccurate estimates of discharges for selected recurrence intervals, changes in basin characteristics, and relatively low quality elevation data used for flood delineation. FEMA estimates that 45 percent of effective maps are over 10 years old (FEMA, 1997). Consequently, Congress has mandated the updating and periodic review of existing maps, which have cost the Nation almost 3 billion (1997) dollars. The need to update maps and the cost of doing so were the primary motivations for piloting a more cost-effective and efficient updating method. New technologies such as Geographic Information Systems and LIDAR (Light Detection and Ranging) elevation mapping are key to improving the efficiency of flood map updating, but they also improve the accuracy, detail, and usefulness of the resulting digital flood maps. GISs produce digital maps without manual estimation of inundated areas between
McCann, Liza J; Pilkington, Clarissa A; Huber, Adam M; Ravelli, Angelo; Appelbe, Duncan; Kirkham, Jamie J; Williamson, Paula R; Aggarwal, Amita; Christopher-Stine, Lisa; Constantin, Tamas; Feldman, Brian M; Lundberg, Ingrid; Maillard, Sue; Mathiesen, Pernille; Murphy, Ruth; Pachman, Lauren M; Reed, Ann M; Rider, Lisa G; van Royen-Kerkof, Annet; Russo, Ricardo; Spinty, Stefan; Wedderburn, Lucy R; Beresford, Michael W
This study aimed to develop consensus on an internationally agreed dataset for juvenile dermatomyositis (JDM), designed for clinical use, to enhance collaborative research and allow integration of data between centres. A prototype dataset was developed through a formal process that included analysing items within existing databases of patients with idiopathic inflammatory myopathies. This template was used to aid a structured multistage consensus process. Exploiting Delphi methodology, two web-based questionnaires were distributed to healthcare professionals caring for patients with JDM identified through email distribution lists of international paediatric rheumatology and myositis research groups. A separate questionnaire was sent to parents of children with JDM and patients with JDM, identified through established research networks and patient support groups. The results of these parallel processes informed a face-to-face nominal group consensus meeting of international myositis experts, tasked with defining the content of the dataset. This developed dataset was tested in routine clinical practice before review and finalisation. A dataset containing 123 items was formulated with an accompanying glossary. Demographic and diagnostic data are contained within form A collected at baseline visit only, disease activity measures are included within form B collected at every visit and disease damage items within form C collected at baseline and annual visits thereafter. Through a robust international process, a consensus dataset for JDM has been formulated that can capture disease activity and damage over time. This dataset can be incorporated into national and international collaborative efforts, including existing clinical research databases. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Koldby, Sven; Schou Jensen, Iben
Clinical information systems do not always support clinician workflows. An increasing number of unintended clinical incidents might be related to implementation of clinical information systems and to a new registration praxis of unintended clinical incidents. Evidence of performing clinical simulations before implementation of new clinical information systems provides the basis for use of this method. The intention has been to evaluate patient safety issues, functionality, workflow, and usefulness of a new solution before implementation in the hospitals. Use of a solution which integrates digital dictation and the EHR (electronic health record) were simulated in realistic and controlled clinical environments. Useful information dealing with workflow and patient safety were obtained. The clinical simulation demonstrated that the EHR locks during use of the integration of digital dictation, thus making it impossible to use the EHR or connected applications during digital dictation. The results of the simulations showed that the tested and evaluated solution does not support the clinical workflow. Conducting the simulations enabled us to improve the solution before implementation, but further development is necessary before implementation of the solution.
Spath, M; Buttlar, L
The majority of nurses surveyed used the library on a regular but limited basis to obtain information needed in caring for or making decisions about their patients. A minority indicated that the libraries in their own institutions totally met their information needs. In fact, only 4% depended on the library to stay abreast of new information and developments in the field. Many of the nurses had their own journal subscriptions, which could account in part for the limited use of libraries and the popularity of the professional journal as the key information source. This finding correlates with the research of Binger and Huntsman, who found that 95% of staff development educators relied on professional journal literature to keep up with current information in the field, and only 45% regularly monitored indexing-and-abstracting services. The present study also revealed that nurses seek information from colleagues more than from any other source, supporting the findings of Corcoran-Perry and Graves. Further research is necessary to clarify why nurses use libraries on a limited basis. It appears, as Bunyan and Lutz contend, that a more aggressive approach to marketing the library to nurses is needed. Further research should include an assessment of how the library can meet the information needs of nurses for both research and patient care. Options to be considered include offering library orientation sessions for new staff nurses, providing current-awareness services by circulating photocopied table-of-contents pages, sending out reviews of new monographs, inviting nurses to submit search requests on a topic, scheduling seminars and workshops that teach CD-ROM and online search strategies, and providing information about electronic databases covering topics related to nursing. Information on databases may be particularly important in light of the present study's finding that databases available in CD-ROM format are consulted very little. Nursing education programs should
Guy Paré; Claude Sicotte; Hélène Jacques
OBJECTIVE: Motivated by the need to push further our understanding of physicians' acceptance of clinical information systems, we propose a relatively new construct, namely, psychological ownership...
Cheng, Chun-Ting; Lin, Chiu-Chu
Obtaining informed consent and ensuring patient autonomy are critical to implementing a patient-centered model of healthcare. Informed consent is a complex process of communication that includes three elements: disclosure, competence in making decisions, and voluntariness. However, individual patient factors, doctor-patient interaction, and cultural issues are known to influence the process of obtaining informed consent. Individual patient factors include the ability of patients to understand and determine their intent; doctor-patient interaction includes communication skills; and cultural issues include the expectations of patients with regard to family involvement in medical decision-making and in decision-making motives. After assessing the relevant influencing factors, healthcare providers typically provide patients with comprehensive information on the benefits and risks of treatment as well as related alternatives. Moreover, healthcare providers typically provide patients with audio/video, Internet, and written information with illustrations based on individual patient needs. In addition to the above, we suggest that healthcare providers proactively adopt the perspective of patients in order to better encourage patients to address questions, to engage with patients in more productive discussions, and to take the initiative to explain and clarify patients' questions in order to minimize anxiety. This approach will help ensure that patients are adequately informed and free from coercion so that they make appropriate healthcare-related decisions. However, even under this optimal situation, healthcare providers must emphasize the needs of their patients and respect their decisions.
Background: Barrett's esophagus is the precursor of esophageal adenocarcinoma with a 5-year survival rate of 25-30%. Objective: To define clinically useful biomarkers for transcriptional profiling in South African patients with Barrett's esophagus in order to identify those patients with an increased cancer risk necessitating ...
is the cornerstone of health research ethics and a requirement for clinical research in South Africa. The South ... we compared the following documents: International Conference on Harmonisation: E6 Consolidated .... decision to consult family members and community leaders and not assume that they have the same world ...
Ju, John Chen; Gan, Soon Ann; Tan Siew Wee, Justine; Huang Yuchi, Peter; Mei Mei, Chan; Wong Mei Mei, Sharon; Fong, Kam Weng
In major cancer centers, heavy patients load and multiple registration stations could cause significant wait time, and can be result in patient complains. Real-time patient journey data and visual display are useful tools in hospital patient queue management. This paper demonstrates how we capture patient queue data without deploying any tracing devices; and how to convert data into useful patient journey information to understand where interventions are likely to be most effective. During our system development, remarkable effort has been spent on resolving data discrepancy and balancing between accuracy and system performances. A web-based dashboard to display real-time information and a framework for data analysis were also developed to facilitate our clinics' operation. Result shows our system could eliminate more than 95% of data capturing errors and has improved patient wait time data accuracy since it was deployed.
Tannery, Nancy H; Epstein, Barbara A; Wessel, Charles B; Yarger, Frances; LaDue, John; Klem, Mary Lou
In 2008, a clinical information tool was developed and embedded in the electronic health record system of an academic medical center. In 2009, the initial information tool, Clinical-e, was superseded by a portal called Clinical Focus, with a single search box enabling a federated search of selected online information resources. To measure the usefulness and impact of Clinical Focus, a survey was used to gather feedback about users' experience with this clinical resource. The survey determined what type of clinicians were using this tool and assessed user satisfaction and perceived impact on patient care decision making. Initial survey results suggest the majority of respondents found Clinical Focus easy to navigate, the content easy to read, and the retrieved information relevant and complete. The majority would recommend Clinical Focus to their colleagues. Results indicate that this tool is a promising area for future development.
Cheng, Lionel T E; Zheng, Jiaping; Savova, Guergana K; Erickson, Bradley J
Information in electronic medical records is often in an unstructured free-text format. This format presents challenges for expedient data retrieval and may fail to convey important findings. Natural language processing (NLP) is an emerging technique for rapid and efficient clinical data retrieval. While proven in disease detection, the utility of NLP in discerning disease progression from free-text reports is untested. We aimed to (1) assess whether unstructured radiology reports contained sufficient information for tumor status classification; (2) develop an NLP-based data extraction tool to determine tumor status from unstructured reports; and (3) compare NLP and human tumor status classification outcomes. Consecutive follow-up brain tumor magnetic resonance imaging reports (2000--2007) from a tertiary center were manually annotated using consensus guidelines on tumor status. Reports were randomized to NLP training (70%) or testing (30%) groups. The NLP tool utilized a support vector machines model with statistical and rule-based outcomes. Most reports had sufficient information for tumor status classification, although 0.8% did not describe status despite reference to prior examinations. Tumor size was unreported in 68.7% of documents, while 50.3% lacked data on change magnitude when there was detectable progression or regression. Using retrospective human classification as the gold standard, NLP achieved 80.6% sensitivity and 91.6% specificity for tumor status determination (mean positive predictive value, 82.4%; negative predictive value, 92.0%). In conclusion, most reports contained sufficient information for tumor status determination, though variable features were used to describe status. NLP demonstrated good accuracy for tumor status classification and may have novel application for automated disease status classification from electronic databases.
Villalba-Mora, Elena; Casas, Isabel; Lupiañez-Villanueva, Francisco
Technologies: Electronic Health Records (EHR), ePrescription and patient management and telemedicine services. Results from an ordered logit model showed that the frequency of use of HIT is associated with the physicians' perceived usefulness. Lack of financing appeared as a common barrier to the adoption...... of the three types of services. For ePrescription and patient management, the physician's lack of skills is still a barrier. In the case of telemedicine services, lack of security and lack of interest amongst professionals are the existing barriers. CONCLUSIONS: EHR functionalities are fully adopted, in terms...... of perceived usefulness. EPrescription and patient management are almost fully adopted, while telemedicine is in an early stage of adoption....
Epstein, Barbara A; Tannery, Nancy H; Wessel, Charles B; Yarger, Frances; LaDue, John; Fiorillo, Anthony B
What is the process of developing a clinical information tool to be embedded in the electronic health record of a very large and diverse academic medical center? The development took place at the University of Pittsburgh Health Sciences Library System. The clinical information tool developed is a search box with subject tabs to provide quick access to designated full-text information resources. Each subject tab offers a federated search of a different pool of resources. Search results are organized "on the fly" into meaningful categories using clustering technology and are directly accessible from the results page. After more than a year of discussion and planning, a clinical information tool was embedded in the academic medical center's electronic health record. The library successfully developed a clinical information tool, called Clinical-e, for use at the point of care. Future development will refine the tool and evaluate its impact and effectiveness.
Dendrou, Calliope A; McVean, Gil; Fugger, Lars
Neuroinflammation is emerging as a central process in many neurological conditions, either as a causative factor or as a secondary response to nervous system insult. Understanding the causes and consequences of neuroinflammation could, therefore, provide insight that is needed to improve therapeutic interventions across many diseases. However, the complexity of the pathways involved necessitates the use of high-throughput approaches to extensively interrogate the process, and appropriate strategies to translate the data generated into clinical benefit. Use of 'big data' aims to generate, integrate and analyse large, heterogeneous datasets to provide in-depth insights into complex processes, and has the potential to unravel the complexities of neuroinflammation. Limitations in data analysis approaches currently prevent the full potential of big data being reached, but some aspects of big data are already yielding results. The implementation of 'omics' analyses in particular is becoming routine practice in biomedical research, and neuroimaging is producing large sets of complex data. In this Review, we evaluate the impact of the drive to collect and analyse big data on our understanding of neuroinflammation in disease. We describe the breadth of big data that are leading to an evolution in our understanding of this field, exemplify how these data are beginning to be of use in a clinical setting, and consider possible future directions.
Ballermann, Mark; Shaw, Nicola T; Mayes, Damon C; Gibney, R T Noel
Electronic documentation methods may assist critical care providers with information management tasks in Intensive Care Units (ICUs). We conducted a quasi-experimental observational study to investigate patterns of information tool use by ICU physicians, nurses, and respiratory therapists during verbal communication tasks. Critical care providers used tools less at 3 months after the CCIS introduction. At 12 months, care providers referred to paper and permanent records, especially during shift changes. The results suggest potential areas of improvement for clinical information systems in assisting critical care providers in ensuring informational continuity around their patients.
Erickson, Wallace P.
Primarily due to concerns generated from observed raptor mortality at the Altamont Pass (CA) wind plant, one of the first commercial electricity generating wind plants in the U.S., new proposed wind projects both within and outside of California have received a great deal of scrutiny and environmental review. A large amount of baseline and operational monitoring data have been collected at proposed and existing U.S. wind plants. The primary use of the avian baseline data collected at wind developments has been to estimate the overall project impacts (e.g., very low, low, moderate, and high relative mortality) on birds, especially raptors and sensitive species (e.g., state and federally listed species). In a few cases, these data have also been used for guiding placement of turbines within a project boundary. This new information has strengthened our ability to accurately predict and mitigate impacts from new projects. This report should assist various stakeholders in the interpretation and use of this large information source in evaluating new projects. This report also suggests that the level of baseline data (e.g., avian use data) required to adequately assess expected impacts of some projects may be reduced. This report provides an evaluation of the ability to predict direct impacts on avian resources (primarily raptors and waterfowl/waterbirds) using less than an entire year of baseline avian use data (one season, two seasons, etc.). This evaluation is important because pre-construction wildlife surveys can be one of the most time-consuming aspects of permitting wind power projects. For baseline data, this study focuses primarily on standardized avian use data usually collected using point count survey methodology and raptor nest survey data. In addition to avian use and raptor nest survey data, other baseline data is usually collected at a proposed project to further quantify potential impacts. These surveys often include vegetation mapping and state or
Yehuda, Rachel; Bierer, Linda M; Pratchett, Laura C; Pelcovitz, Michelle
Combat veterans with posttraumatic stress disorder (PTSD) demonstrate less robust improvement following treatments than do civilians with PTSD. This paper discusses a theoretical model for evaluating treatment response based on the extent of change in biological markers of symptom severity or resilience between treatment initiation and termination. Such analysis permits a determination of biological change associated with the liberal criteria commonly used to determine treatment response in combat PTSD, and a comparison of this to the biological change associated with clinical response determined according to the conservative definition more appropriate to civilian PTSD. Interim data supporting the utility of this approach is presented based on preliminary analyses from our work in progress. We propose that future studies consider the unique consequences of combat trauma and develop treatments that incorporate the complex nature of the exposure and response characteristic of a veteran population. © 2010 Association for Research in Nervous and Mental Disease.
Full Text Available Lynne LL Robinson,1 Khaled MK Ismail1,21Department of Obstetrics and Gynaecology, Birmingham Women’s Hospital, Birmingham, UK; 2Birmingham Centre for Women’s and Children’s Health, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UKAbstract: Premenstrual disorders encompass a spectrum that ranges from mild cyclical psychological and somatic symptoms to the rarer but much-more-severe premenstrual dysphoric disorder. This condition is serious and the etiology is unclear, but possible causes include genetic factors, hormonal fluctuations, and neurotransmitter dysfunctions. Differentiation from other affective disorders can be difficult but is key to providing appropriate management. This comprehensive review will discuss the most-recent classification of premenstrual disorders, etiology, diagnosis, and potential current management strategies.Keywords: premenstrual dysphoric disorder, progesterone, oestrogen, oophrectomy, GNRH analogues
Stanley, Donald Edward; Campos, Daniel G
This article describes reasoning strategies used by clinicians in different diagnostic circumstances and how these modes of inquiry may allow further insight into the evaluation and treatment of patients. Specifically, it aims to make explicit the implicit logical considerations that guide a variety of strategies in the diagnostic process, as exemplified in specific clinical cases. It focuses, in particular, in strategies that clinicians use to move from a large set of possible diagnoses initially suggested by abductive inferences - the process of hypothesis generation that creates a diagnostic space - to a narrower set or even to a single 'best' diagnosis, where the criteria to determine what is 'best' may differ according to different strategies. Experienced clinicians should have a diversified kit of strategies - for example, Bayesian probability or inference to a lovely explanation - to select from among previously generated hypotheses, rather than rely on any one approach every time. © 2015 John Wiley & Sons, Ltd.
Gresnigt, Marco M M; Kalk, Warner; Özcan, Mutlu
This study evaluated the survival rate of ceramic laminate veneers bonded to teeth with and without existing composite restorations (ECR). Twenty patients (mean age: 49.7 years) received 92 feldspathic ceramic laminate veneers (Shofu Vintage AL) on the maxillary teeth (intact teeth: n = 26; teeth with ECR: n = 66). Preparations with incisal overlap were made, and ECR of good quality were not removed but conditioned using silica coating (CoJet) and silanization (ESPE-Sil). Enamel and dentin were etched with 38% H3PO4 for 15-30 s and rinsed 30 s; adhesive resin (Excite) was applied, and laminate veneers were then cemented (Variolink Veneer). Restorations were evaluated at baseline and thereafter every 6 months using modified United States Public Health Service criteria. Mean observation period was 21.6 months. Overall, five absolute failures were encountered (fractures: n = 3; chipping: n = 1; debonding: n = 1), resulting in a survival rate of 94.6% (Kaplan-Meier). Survival rates of the laminates bonded to teeth without (96%) and with ECR (93.5%) did not show significant differences (p > 0.05). Slight marginal defects (16 of 87 laminates) and slight marginal discoloration at the margins were noted (12 of 87 laminates) until the final recall. Secondary caries and endodontic complications were not detected in any of the teeth. The clinical survival of ceramic laminate veneers up to 40 months was not significantly influenced when they were bonded onto intact teeth or onto teeth with ECR. When no caries is present, it may not be necessary to replace existing composite restorations prior to cementation of ceramic laminate veneers.
Duan, L.; Street, W. N.; Xu, E.
Recommender systems have been extensively studied to present items, such as movies, music and books that are likely of interest to the user. Researchers have indicated that integrated medical information systems are becoming an essential part of the modern healthcare systems. Such systems have evolved to an integrated enterprise-wide system. In particular, such systems are considered as a type of enterprise information systems or ERP system addressing healthcare industry sector needs. As part of efforts, nursing care plan recommender systems can provide clinical decision support, nursing education, clinical quality control, and serve as a complement to existing practice guidelines. We propose to use correlations among nursing diagnoses, outcomes and interventions to create a recommender system for constructing nursing care plans. In the current study, we used nursing diagnosis data to develop the methodology. Our system utilises a prefix-tree structure common in itemset mining to construct a ranked list of suggested care plan items based on previously-entered items. Unlike common commercial systems, our system makes sequential recommendations based on user interaction, modifying a ranked list of suggested items at each step in care plan construction. We rank items based on traditional association-rule measures such as support and confidence, as well as a novel measure that anticipates which selections might improve the quality of future rankings. Since the multi-step nature of our recommendations presents problems for traditional evaluation measures, we also present a new evaluation method based on average ranking position and use it to test the effectiveness of different recommendation strategies.
Karunaratne, Asuntha S; Korenman, Stanley G; Thomas, Samantha L; Myles, Paul S; Komesaroff, Paul A
To assess the efficacy, with respect to participant understanding of information, of a computer-based approach to communication about complex, technical issues that commonly arise when seeking informed consent for clinical research trials. An open, randomised controlled study of 60 patients with diabetes mellitus, aged 27-70 years, recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and Baker IDI Heart and Diabetes Institute, Melbourne. Participants were asked to read information about a mock study via a computer-based presentation (n = 30) or a conventional paper-based information statement (n = 30). The computer-based presentation contained visual aids, including diagrams, video, hyperlinks and quiz pages. Understanding of information as assessed by quantitative and qualitative means. Assessment scores used to measure level of understanding were significantly higher in the group that completed the computer-based task than the group that completed the paper-based task (82% v 73%; P = 0.005). More participants in the group that completed the computer-based task expressed interest in taking part in the mock study (23 v 17 participants; P = 0.01). Most participants from both groups preferred the idea of a computer-based presentation to the paper-based statement (21 in the computer-based task group, 18 in the paper-based task group). A computer-based method of providing information may help overcome existing deficiencies in communication about clinical research, and may reduce costs and improve efficiency in recruiting participants for clinical trials.
Maeda, Hideki; Kurokawa, Tatsuo
This study exhaustively and historically investigated the status of drug lag for oncology drugs approved in Japan. We comprehensively investigated oncology drugs approved in Japan between April 2001 and July 2014, using publicly available information. We also examined changes in the status of drug lag between Japan and the United States, as well as factors influencing drug lag. This study included 120 applications for approval of oncology drugs in Japan. The median difference over a 13-year period in the approval date between the United States and Japan was 875 days (29.2 months). This figure peaked in 2002, and showed a tendency to decline gradually each year thereafter. In 2014, the median approval lag was 281 days (9.4 months). Multiple regression analysis identified the following potential factors that reduce drug lag: "Japan's participation in global clinical trials"; "bridging strategies"; "designation of priority review in Japan"; and "molecularly targeted drugs". From 2001 to 2014, molecularly targeted drugs emerged as the predominant oncology drug, and the method of development has changed from full development in Japan or bridging strategy to global simultaneous development by Japan's taking part in global clinical trials. In line with these changes, the drug lag between the United States and Japan has significantly reduced to less than 1 year.
Welch, Brandon M; Rodriguez-Loya, Salvador; Eilbeck, Karen; Kawamoto, Kensaku
Whole genome sequence (WGS) information could soon be routinely available to clinicians to support the personalized care of their patients. At such time, clinical decision support (CDS) integrated into the clinical workflow will likely be necessary to support genome-guided clinical care. Nevertheless, developing CDS capabilities for WGS information presents many unique challenges that need to be overcome for such approaches to be effective. In this manuscript, we describe the development of a prototype CDS system that is capable of providing genome-guided CDS at the point of care and within the clinical workflow. To demonstrate the functionality of this prototype, we implemented a clinical scenario of a hypothetical patient at high risk for Lynch Syndrome based on his genomic information. We demonstrate that this system can effectively use service-oriented architecture principles and standards-based components to deliver point of care CDS for WGS information in real-time.
Full Text Available The uptake of electronic records and information technology support in intensive care medicine has been slower than many people predicted. One of the engineering challenges to overcome has been the subtle, but important, variation in clinical practice in different units. A relatively recent innovation that addresses this challenge is practitioner-customizable clinical information systems, allowing clinicians wide scope in adjusting their systems to suit their clinical practice. However, these systems present a significant design challenge, not only of added technical complexity, but in providing tools that support clinicians in doing many of the tasks of a software engineer. This paper reviews the use of a commercially available clinical information system that is intended to be practitioner-customizable, and considers the further design and development of tools to support healthcare practitioners doing end-user customization on their own clinical information systems.
Dee, Cheryl; Stanley, Ellen E
This research was conducted to provide new insights on clinical nurses' and nursing students' current use of health resources and libraries and deterrents to their retrieval of electronic clinical information, exploring implications from these findings for health sciences librarians. Questionnaires, interviews, and observations were used to collect data from twenty-five nursing students and twenty-five clinical nurses. Nursing students and clinical nurses were most likely to rely on colleagues and books for medical information, while other resources they frequently cited included personal digital assistants, electronic journals and books, and drug representatives. Significantly more nursing students than clinical nurses used online databases, including CINAHL and PubMed, to locate health information, and nursing students were more likely than clinical nurses to report performing a database search at least one to five times a week. Nursing students made more use of all available resources and were better trained than clinical nurses, but both groups lacked database-searching skills. Participants were eager for more patient care information, more database training, and better computer skills; therefore, health sciences librarians have the opportunity to meet the nurses' information needs and improve nurses' clinical information-seeking behavior.
Mota, Fábio Batista; Ferreira Júnior, Hamilton de Moura
The aim of this article is to investigate the adoption and use of information and communication technologies within private dialysis clinics in Bahia State. A case study was developed with companies by applying, to clinics' managerial teams, a research questionnaire adapted from RedeSist and from PINTEC. The sample included 20 companies, listed by CNES of the Ministry of Health, and obtained a positive usage rate data of 60%. The collected quantitative information was analyzed by interviewees' answer frequency distribution. Conclusion indicates that the adoption of information and communication technologies by the clinics is not directly related to their access to these technologies but to the under usage of their economical potential.
Schou Jensen, Iben; Koldby, Sven
digital dictation and the EHR (electronic health record) were simulated in realistic and controlled clinical environments. Useful information dealing with workflow and patient safety were obtained. The clinical simulation demonstrated that the EHR locks during use of the integration of digital dictation......, thus making it impossible to use the EHR or connected applications during digital dicta-tion. The results of the simulations showed that the tested and evaluated solution does not support the clinical workflow. Conducting the simulations enabled us to improve the solution before implementation...
Sources of drug information such as package inserts (PIs) and interview forms (IFs) and existing drug information databases provide primarily document-based and numerical information. For this reason, it is not easy to obtain a complete picture of the information concerning many drugs with similar effects or to understand differences among drugs. The visualization of drug information may help provide a large amount of information in a short period, relieve the burden on medical workers, facilitate a comprehensive understanding and comparison of drugs, and contribute to improvements in patients' QOL. At our department, we are developing an approach to convert information on side effects obtained from PIs of many drugs with similar effects into visual maps reflecting the data structure through competitive learning using the self-organizing map (SOM) technique of Kohonen, which is a powerful method for pattern recognition, to facilitate the grasping of all available information and differences among drugs, to anticipate the appearance of side effects; we are also evaluating the possibility of its clinical application. In this paper, this approach is described by taking the examples of antibiotics, antihypertensive drugs, and diabetes drugs.
Full Text Available Background: Well-working health information systems are considered vital with the quality of health data ranked of highest importance for decision making at patient care and policy levels. In particular, health facilities play an important role, since they are not only the entry point for the national health information system but also use health data (and primarily for patient care. Design: A multiple case study was carried out between March and August 2012 at the antenatal care (ANC clinics of two private and one public Kenyan hospital to describe clinical information systems and assess the quality of information. The following methods were developed and employed in an iterative process: workplace walkthroughs, structured and in-depth interviews with staff members, and a quantitative assessment of data quality (completeness and accurate transmission of clinical information and reports in ANC. Views of staff and management on the quality of employed information systems, data quality, and influencing factors were captured qualitatively. Results: Staff rated the quality of information higher in the private hospitals employing computers than in the public hospital which relies on paper forms. Several potential threats to data quality were reported. Limitations in data quality were common at all study sites including wrong test results, missing registers, and inconsistencies in reports. Feedback was seldom on content or quality of reports and usage of data beyond individual patient care was low. Conclusions: We argue that the limited data quality has to be seen in the broader perspective of the information systems in which it is produced and used. The combination of different methods has proven to be useful for this. To improve the effectiveness and capabilities of these systems, combined measures are needed which include technical and organizational aspects (e.g. regular feedback to health workers and individual skills and motivation.
Hahn, Daniel; Wanjala, Pepela; Marx, Michael
Background Well-working health information systems are considered vital with the quality of health data ranked of highest importance for decision making at patient care and policy levels. In particular, health facilities play an important role, since they are not only the entry point for the national health information system but also use health data (and primarily) for patient care. Design A multiple case study was carried out between March and August 2012 at the antenatal care (ANC) clinics of two private and one public Kenyan hospital to describe clinical information systems and assess the quality of information. The following methods were developed and employed in an iterative process: workplace walkthroughs, structured and in-depth interviews with staff members, and a quantitative assessment of data quality (completeness and accurate transmission of clinical information and reports in ANC). Views of staff and management on the quality of employed information systems, data quality, and influencing factors were captured qualitatively. Results Staff rated the quality of information higher in the private hospitals employing computers than in the public hospital which relies on paper forms. Several potential threats to data quality were reported. Limitations in data quality were common at all study sites including wrong test results, missing registers, and inconsistencies in reports. Feedback was seldom on content or quality of reports and usage of data beyond individual patient care was low. Conclusions We argue that the limited data quality has to be seen in the broader perspective of the information systems in which it is produced and used. The combination of different methods has proven to be useful for this. To improve the effectiveness and capabilities of these systems, combined measures are needed which include technical and organizational aspects (e.g. regular feedback to health workers) and individual skills and motivation. PMID:23993022
Hahn, Daniel; Wanjala, Pepela; Marx, Michael
Well-working health information systems are considered vital with the quality of health data ranked of highest importance for decision making at patient care and policy levels. In particular, health facilities play an important role, since they are not only the entry point for the national health information system but also use health data (and primarily) for patient care. A multiple case study was carried out between March and August 2012 at the antenatal care (ANC) clinics of two private and one public Kenyan hospital to describe clinical information systems and assess the quality of information. The following methods were developed and employed in an iterative process: workplace walkthroughs, structured and in-depth interviews with staff members, and a quantitative assessment of data quality (completeness and accurate transmission of clinical information and reports in ANC). Views of staff and management on the quality of employed information systems, data quality, and influencing factors were captured qualitatively. Staff rated the quality of information higher in the private hospitals employing computers than in the public hospital which relies on paper forms. Several potential threats to data quality were reported. Limitations in data quality were common at all study sites including wrong test results, missing registers, and inconsistencies in reports. Feedback was seldom on content or quality of reports and usage of data beyond individual patient care was low. We argue that the limited data quality has to be seen in the broader perspective of the information systems in which it is produced and used. The combination of different methods has proven to be useful for this. To improve the effectiveness and capabilities of these systems, combined measures are needed which include technical and organizational aspects (e.g. regular feedback to health workers) and individual skills and motivation.
Farri, O; Rahman, A; Monsen, K A; Zhang, R; Pakhomov, S V; Pieczkiewicz, D S; Speedie, S M; Melton, G B
EHR clinical document synthesis by clinicians may be time-consuming and error-prone due to the complex organization of narratives, excessive redundancy within documents, and, at times, inadvertent proliferation of data inconsistencies. Development of EHR systems that are easily adaptable to the user's work processes requires research into visualization techniques that can optimize information synthesis at the point of care. To evaluate the effect of a prototype visualization tool for clinically relevant new information on clinicians' synthesis of EHR clinical documents and to understand how the tool may support future designs of clinical document user interfaces. A mixed methods approach to analyze the impact of the visualization tool was used with a sample of eight medical interns as they synthesized EHR clinical documents to accomplish a set of four pre-formed clinical scenarios using a think-aloud protocol. Differences in the missing (unretrieved) patient information (2.3±1.2 [with the visualization tool] vs. 6.8±1.2 [without the visualization tool], p = 0.08) and accurate inferences (1.3±0.3 vs 2.3±0.3, p = 0.09) were not statistically significant but suggest some improvement with the new information visualization tool. Despite the non-significant difference in total times to task completion (43±4 mins vs 36±4 mins, p = 0.35) we observed shorter times for two scenarios with the visualization tool, suggesting that the time-saving benefits may be more evident with certain clinical processes. Other observed effects of the tool include more intuitive navigation between patient details and increased efforts towards methodical synthesis of clinical documents. Our study provides some evidence that new information visualization in clinical notes may positively influence synthesis of patient information from EHR clinical documents. Our findings provide groundwork towards a more effective display of EHR clinical documents using advanced visualization applications.
Xu, Jia-Qi; Choy, Jacky C P; Tang, Jennifer Y M; Liu, Tian-Yin; Luo, Hao; Lou, Vivian W Q; Lum, Terry Y S; Wong, Gloria H Y
To investigate the predictive value of symptoms of dementia that the person or an informant noticed spontaneously in determining the clinical severity of dementia. Cross-sectional. Community-based open-referral dementia assessment service in Hong Kong between 2005 and 2013. Help-seekers for dementia assessment service and their informants (N = 965 dyads). Participants underwent a clinical dementia interview based on the Clinical Dementia Rating. Spontaneous complaints that the person and the informant made that had prompted their help-seeking of groups with interview results suggestive of no impairment, mild cognitive impairment, and dementia were compared. Logistic regression was used to evaluate the predictive value of spontaneous complaints for clinical severity. Independent raters blinded to clinical results coded spontaneously reported symptoms into theoretical themes: memory, executive function, language, time and place orientation, neuropsychiatric, mood, and avolition. Memory problems were the most frequently reported complaints for participants (87.7%) and their informants (95.5%), followed by self-reported language (33.0%) and informant-reported orientation (33.0%) difficulties. Informant-reported but not self-reported symptoms predicted clinical severity. Compared with the persons themselves, informants reported more pervasive symptoms corresponding to clinical severity. Persons with dementia self-reported fewer types of symptoms than their healthy or mildly impaired counterparts. Spontaneously reported language and orientation symptoms by the informant distinguished persons with mild or worse dementia (P < .001, Nagelkerke coefficient of determination = 29.7%, percentage correct 85.6%). The type and pervasiveness of symptoms spontaneously that informants reported predicted clinical severity. This may provide a quick reference for triage. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.
Croughs, Mieke; de Gouw, Annemarie; Remmen, Roy; Van den Ende, Jef
Background: A substantial proportion of travel clinic visitors have sexual encounters while abroad. Hence, guidelines on travel health recommend discussing sexual risk in a pre-travel consultation. However, previous studies showed that it often is not discussed. Although travel clinic visitors usually do receive written information on sexual risk abroad, few data are available on whether this information is read. Therefore, this prospective cohort study in travel clinic visitors was performed. Methods: Travel clinic visitors were invited to complete a questionnaire after return from their journey. Results: A total of 130 travellers (55%) responded. Half of them recorded they read the information on sexual risk. Male gender (OR 9.94 95% CI 3.12 – 31.63) and ‘travelling with others’ (OR 2.7 95% CI 1.29 – 5.78) were significant independent predictors of reading the information on sexual risk. High risk travellers, i.e. those travelling without a steady partner, were less likely to have read it. Although websites and apps were mentioned as better methods of providing information, none of the participants visited the websites on sexual behaviour and sexually transmitted infections recommended in the travel health brochure. Conclusion: Only half of travel clinic visitors read information on sexual risk in the health brochure received in the clinic and none of them visited the related websites mentioned in the brochure. Further research to identify the most effective way to inform travellers about sexual risk is needed. PMID:28989499
Croughs, Mieke; de Gouw, Annemarie; Remmen, Roy; Van den Ende, Jef
A substantial proportion of travel clinic visitors have sexual encounters while abroad. Hence, guidelines on travel health recommend discussing sexual risk in a pre-travel consultation. However, previous studies showed that it often is not discussed. Although travel clinic visitors usually do receive written information on sexual risk abroad, few data are available on whether this information is read. Therefore, this prospective cohort study in travel clinic visitors was performed. Travel clinic visitors were invited to complete a questionnaire after return from their journey. A total of 130 travellers (55%) responded. Half of them recorded they read the information on sexual risk. Male gender (OR 9.94 95% CI 3.12 - 31.63) and 'travelling with others' (OR 2.7 95% CI 1.29 - 5.78) were significant independent predictors of reading the information on sexual risk. High risk travellers, i.e. those travelling without a steady partner, were less likely to have read it. Although websites and apps were mentioned as better methods of providing information, none of the participants visited the websites on sexual behaviour and sexually transmitted infections recommended in the travel health brochure. Only half of travel clinic visitors read information on sexual risk in the health brochure received in the clinic and none of them visited the related websites mentioned in the brochure. Further research to identify the most effective way to inform travellers about sexual risk is needed.
Pick, Andrew; Gilbert, Kayleigh; McCaul, James
Informed consent is fundamental to the protection of the rights, safety and wellbeing of patients in clinical research. For consent to be valid, patients must first be given all the information they need about the proposed research to be able to decide whether they would like to take part. This material should be presented in a way that is easy for them to understand. This article explores the importance of communication in clinical research, and how more effective communication with patients during the informed consent process can ensure they are fully informed.
Jóźwiak, Sergiusz; Kotulska, Katarzyna; Berkowitz, Noah; Brechenmacher, Thomas; Franz, David Neal
To assess the long-term safety of everolimus in young children with tuberous sclerosis complex (TSC)-associated subependymal giant cell astrocytoma (SEGA). EXamining everolimus In a Study of Tuberous Sclerosis Complex-1 (EXIST-1) was a multicenter, randomized, double-blind phase 3 study with an open-label extension evaluating the efficacy and tolerability of everolimus in patients with TSC-associated SEGA. Everolimus was initiated at 4.5 mg/m(2)/day and titrated to blood trough levels of 5-15 ng/mL. Post hoc analysis of safety data (adverse events [AEs]) was performed in a subgroup of patients aged <3 years at everolimus initiation. Eighteen patients (median age 1.82 years) were included; 16 were still receiving everolimus at the analysis cut-off date of January 11, 2013. Median everolimus exposure was 31.1 months (range, 11.5-39 months). One patient discontinued treatment because of AEs (ie, Acinetobacter bacteremia, increased blood alkaline phosphatase, and viral infection). AEs were reported in all patients, but events were mostly grade 1/2 in severity; 12 patients (66.7%) experienced grade 3 events, and 2 patients (11.1%) reported grade 4 events. The most common AEs were stomatitis, cough, pharyngitis, and pyrexia; no new safety issues were identified in this population. Serious AEs were reported in 50% of patients; these were suspected to be medication related in 4 patients (22.2%). Everolimus appears to be a safe therapeutic option for patients aged <3 years with TSC-associated SEGA. The small sample size in this subpopulation limits interpretation of the results; additional studies in the pediatric population are needed and are underway. ClinicalTrials.gov: NCT00789828. Copyright © 2016 Elsevier Inc. All rights reserved.
... Senator Lister Hill Photo courtesy of Bachrach A Leader in Clinical Trials, Medical Data, & Electronic Health Information This year marks the175th anniversary of the National Library of Medicine (NLM). To strengthen the Library’s mission ...
Smed, Marie; Schultz, Carsten; Getz, Kenneth A.
The collaboration with medical professionals in pharmaceutical clinical trials facilitates opportunities to gain valuable market information concerning product functionality issues, as well as issues related to market implementation and adoption. However, previous research on trial management lacks...
Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador
Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.
Full Text Available BACKGROUND: We tested the relevance of clinical information in the histopathologic evaluation of melanocytic skin neoplasm (MSN. METHODS: Histopathologic specimens from 99 clinically atypical MSN were circulated among ten histopathologists; each case had clinical information available in a database with a five-step procedure (no information; age/sex/location; clinical diagnosis; clinical image; dermoscopic image; each step had a histopathologic diagnosis (D1 through D5; each diagnostic step had a level of diagnostic confidence (LDC ranging from 1 (no diagnostic certainty to 5 (absolute diagnostic certainty. The comparison of the LDC was employed with an analysis of variance (ANOVA for repeated measures. FINDINGS: In D1 (no information, 36/99 cases (36.3% had unanimous diagnosis; in D5 (full information available, 51/99 cases (51.5% had unanimous diagnosis (p for difference between proportions <0.001. The observer agreement expressed as kappa increased significantly from D1 to D5. The mean LDC linearly increased for each observer from D1 through D5 (p for linear trend <0.001. On average, each histopathologist changed his initial diagnosis in 7 cases (range: 2-23. Most diagnostic changes were in D2 (age/sex/location. INTERPRETATION: The histopathologic criteria for the diagnosis of MSN can work as such, but the final histopathologic diagnosis is a clinically-aided interpretation. Clinical data sometimes reverse the initial histopathologic evaluation.
Finkelstein, Mark; Siddiqui, Ammar; Pak, Theodore; Hu, Kevin; Ciccariello, Chloe; Knabben, Vinicius; Chiang, David; Thomas, David C; Meah, Yasmin S
Frequent turnover of staff in medical clinics creates challenges in the maintenance of clinical protocols, workflows, and information management. Care coordination between providers in such a setting can be complex; disruptions in communication may lead to poorer health outcomes and patient satisfaction. Furthermore, protocols change frequently in response to new guidelines, which demands rapid updates to maintain compliance. To address these challenges, we developed an intuitive, end-user editable web-based knowledge management system optimized for use on mobile devices. The resulting system served as a point of care information storage and retrieval tool that providers can reference quickly for operational tasks. Since launch, the platform has allowed our clinic to consolidate knowledge banks, standardize staff training, and streamline information flow during clinic, and is now used extensively by clinic staff. During a one-year period, 175 new pages have been created and 1686 edits have been submitted by users. We posit that a mobile platform for clinical information flow management has significant potential to improve information maintenance and facilitate transfer of up-to-date clinical protocols to new personnel.
Kirschner, S; Lützner, J; Meier, V; Günther, K P; Krummenauer, F
The effects of the introduction of a clinical pathway and enhanced patient information on patients' satisfaction were investigated in the current study. In a prospective cohort study patients were systematically interviewed about the preparation and the clinical course during implantation of a total knee arthroplasty. The study included 132 patients before (cohort I) and 128 after (cohort II) introduction of a clinical pathway. All patients of cohort II were offered the opportunity to attend an enhanced patient information lecture. The collected data were analysed in a descriptive manner. Items with more than 10% negative answers constituted the need for improvement. Regarding preparation of the operation there was a need for improvement of 11 items in cohort I and 4 in cohort II. With respect to the clinical course there was a slight increase from 6 to 7 items that required improvement. The enhanced information about the treatment and the clinical course were assessed positively. Patients were unsatisfied with the individual explanation of the X-rays. Of 128 patients from cohort II, 58 decided to participate in the information session for patients. The patients who had attended were more interested in receiving additional information. The success of the operation (gain in WOMAC score of at least 20%) showed a substantial effect on patient satisfaction. With increased patient information the knowledge and patient satisfaction within clinical pathways can be improved.
...: Prevalence and Clinical Course of Depression Among Patients with Heart Failure, VA HSR&D, Nursing Research... Collection (Prevalence and Clinical course of Depression Among patients with Heart Failure); Comment Request... information needed to identify the patterns of depression in heart failure patients. DATES: Written comments...
Stanciu, Gabriela-Dumitrita; Packer, Rowena Mary Anne; Pakozdy, Akos; Solcan, Gheorghe; Volk, Holger Andreas
We sought to identify the association between clinical risk factors and the diagnosis of idiopathic epilepsy (IE) or structural epilepsy (SE) in cats, using statistical models to identify combinations of discrete parameters from the patient signalment, history and neurological examination findings that could suggest the most likely diagnosis. Data for 138 cats with recurrent seizures were reviewed, of which 110 were valid for inclusion. Seizure aetiology was classified as IE in 57% and SE in 43% of cats. Binomial logistic regression analyses demonstrated that pedigree status, older age at seizure onset (particularly >7years old), abnormal neurological examinations, and ictal vocalisation were associated with a diagnosis of SE compared to IE, and that ictal salivation was more likely to be associated with a diagnosis of IE than SE. These findings support the importance of considering inter-ictal neurological deficits and seizure history in clinical reasoning. Copyright © 2017 Elsevier Ltd. All rights reserved.
Kuchinke, Wolfgang; Karakoyun, Töresin; Ohmann, Christian; Arvanitis, Theodoros N; Taweel, Adel; Delaney, Brendan C; Speedie, Stuart M
Patient data from general practices is already used for many types of epidemiological research and increasingly, primary care systems to facilitate randomized clinical trials. The EU funded project TRANSFoRm aims to create a "Learning Healthcare System" at a European level that is able to support all types of research using primary care data, to recruit patients and follow patients in clinical studies and to improve diagnosis and therapy. The implementation of such a Learning Healthcare System needs an information model for clinical research (CRIM), as an informational backbone to integrate aspects of primary care with clinical trials and database searches. Workflow descriptions and corresponding data objects of two clinical use cases (Gastro-Oesophageal Reflux Disease and Type 2 Diabetes) were described in UML activity diagrams. The components of activity diagrams were mapped to information objects of PCROM (Primary Care Research Object Model) and BRIDG (Biomedical Research Integrated Domain Group) and evaluated. The class diagram of PCROM was adapted to comply with workflow descriptions. The suitability of PCROM, a primary care information model already used for clinical trials, to act as an information model for TRANSFoRm was evaluated and resulted in its extension with 14 new information object types, two extensions of existing objects and the introduction of two new high-ranking concepts (CARE area and ENTRY area). No PCROM component was redundant. Our result illustrates that in primary care based research an important but underestimated portion of research activity takes place in the area of care (e.g. patient consultation, screening, recruitment and response to adverse events). The newly introduced CARE area for care-related research activities accounts for this shift and includes Episode of Care and Encounter as two new basic elements. In the ENTRY area different aspects of data collection were combined, including data semantics for observations, assessment
Hilty, Donald M; Belitsky, Richard; Cohen, Mitchell B; Cabaniss, Deborah L; Dickstein, Leah J; Bernstein, Carol A; Kaplan, Allan S; Scheiber, Stephen C; Crisp-Han, Holly D; Wrzosek, Marika I; Silberman, Edward K
Access to technology in practice helps physicians manage information, communicate, and research topics; however, those in training receive almost no formal preparation for integrating web-based technologies into practice. One reason for this is that many faculty-aside from junior faculty or those in recent generations-did not grow up using Internet communication, may use it minimally, if at all, in their own practices, and may know little about its forms and varieties. This report presents a case to illustrate how these disparities may play out in the supervisory situation and makes suggestions about helping supervisors integrate technology-awareness into their teaching.
Krøll, Lotte Skytte; Hammarlund, Catharina Sjödahl; Linde, Mattias
Aim To evaluate aerobic exercise in migraine and co-existing tension-type headache and neck pain. Methods Consecutively recruited persons with migraine and co-existing tension-type headache and neck pain were randomized into an exercise group or control group. Aerobic exercise consisted of bike/c...
Lorell, Beverly H; Mikita, J Stephen; Anderson, Annick; Hallinan, Zachary P; Forrest, Annemarie
Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed. The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change. There was broad consensus that current practices often fail to meet the ethical obligation to inform potential research participants during the informed consent process. The most frequent single recommendation, which would affect all participants in federally regulated clinical research, was reform of the informed consent document. The interviews also identified the need for reform of clinical research review by institutional review boards, including transitioning to a single institutional review board for multi-site trials. The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations. © The Author(s) 2015.
Lee, Seon Ah
The purpose of this study was to develop a tool to evaluate the quality of a clinical information system (CIS) conceived by nurses and conduct a pilot test with the developed tool as an initial assessment. CIS quality is required for successful implementation in information technology (IT) environments. The study started with the realization that…
de Bruijn, Berry; Carini, Simona; Kiritchenko, Svetlana; Martin, Joel; Sim, Ida
Clinical trials are one of the most valuable sources of scientific evidence for improving the practice of medicine. The Trial Bank project aims to improve structured access to trial findings by including formalized trial information into a knowledge base. Manually extracting trial information from published articles is costly, but automated information extraction techniques can assist. The current study highlights a single architecture to extract a wide array of information elements from full-text publications of randomized clinical trials (RCTs). This architecture combines a text classifier with a weak regular expression matcher. We tested this two-stage architecture on 88 RCT reports from 5 leading medical journals, extracting 23 elements of key trial information such as eligibility rules, sample size, intervention, and outcome names. Results prove this to be a promising avenue to help critical appraisers, systematic reviewers, and curators quickly identify key information elements in published RCT articles.
van Nies, J A B; Tsonaka, R; Gaujoux-Viala, C; Fautrel, B; van der Helm-van Mil, A H M
A prolonged symptom or disease duration at treatment initiation is associated with unfavourable outcomes in rheumatoid arthritis (RA). It is unknown whether this relation is linear, referring to a common 'the-earlier-the-better principle', or whether a transient time frame in which the disease is more susceptible to treatment exists, referring to a 'window of opportunity'. To elucidate this, we evaluated the shape of the associations of symptom duration with persistence of RA. Patients with 1987 RA treated with disease modifying antirheumatic drugs (DMARDs) in the Leiden Early Arthritis Clinic (EAC, n=738) and Evaluation et Suivi de POlyarthrites Indifférenciées Récentes (ESPOIR) (n=533) were studied. Cox proportional hazards regression models using natural cubic splines were performed; the log-HR on DMARD-free sustained remission (the opposite of RA persistence) during 5-year follow-up was plotted against symptom duration. Discrimination was measured using time-dependent receiver operator characteristic curves. Subanalyses were performed stratified for the DMARDs used (methotrexate or other conventional DMARDs) and for anticitrullinated peptide antibody (ACPA). 11.5% (85/738) and 5.4% (29/533) of EAC and ESPOIR RA patients achieved DMARD-free sustained remission. In both cohorts and all analyses, the curves depicting the log-HRs on remission in relation to symptom duration were not linear. The symptom duration with optimal discriminative ability was 14.9 weeks (95% CI 12.3 to 16.0; area under the curve (AUC) 0.61) in the EAC and 19.1 weeks (95% CI 12.3 to 28.0; AUC 0.59) in ESPOIR. For ACPA-positive RA, this was 11.4 weeks (95% CI 7.7 to 79.0; AUC 0.56) and for ACPA-negative RA 15.0 weeks (95% CI 9.7 to 48.7; AUC 0.56). The association between symptom duration and RA persistence is not linear, suggesting the presence of a confined period in which RA is more susceptible to treatment. Published by the BMJ Publishing Group Limited. For permission to use
Lu, Wei; Wang, Daping; Zhu, Weiming; Li, Dingfu; Ouyang, Kan; Peng, Liangquan; Feng, Wenzhe; Li, Hao
The outcomes of double-bundle anterior cruciate ligament reconstruction (DB-ACLR) are becoming controversial. One of the main reasons for the controversy is the techniques for bone tunnel placement. The common technique to place the bone tunnels is to use bony landmarks, while a new approach uses footprint remnants. To investigate if placement of double tunnels using bony landmarks produces the same clinical results as that of using existing footprint remnants. Randomized controlled trial; Level of evidence, 2. A total of 72 male patients were randomly divided into 2 groups of 36 patients each: (A) DB-ACLR tunnel placement using the footprint remnant procedure (EF group) and (B) DB-ACLR tunnel placement using the bony landmark procedure (BL group). All patients were evaluated before and after surgery. Outcomes were measured by KT-2000 arthrometer side-to-side difference, pivot-shift test, and Tegner, Lysholm, and International Knee Documentation Committee (IKDC) scores. Second-look arthroscopic evaluations were performed in 59 cases (28 and 31 cases in the EF and BL groups, respectively). The mean follow-up time was 36.9±4.8 months. Postoperative 3-dimensional computed tomography scans showed that bone sockets were variable on both femoral and tibial sides in the EF group and almost consistent in the BL group. All of the evaluation indexes were significantly improved postoperatively in both groups. There were no revision cases in the EF group and 2 in the BL group. The EF group showed a faster range of motion (ROM) recovery (at 0° to 120°) than did the BL group. At final follow-up, there was no significant difference between the EF and BL groups in Tegner score (5.88±1.39 vs 5.16±1.76; P=.058) or pivot-shift test (34 vs 32; P=.067). The EF group had a larger proportion of patients with IKDC grade A (normal) (33 vs 24; Ptunnel placement showed better functional results with respect to faster ROM recovery, higher subjective outcome scores, and better
Koh, Youngil; Park, Juwon; Ahn, Kwang-Sung; Kim, Inho; Bang, Soo-Mee; Lee, Jae-Hoon; Yoon, Sung-Soo; Soon Lee, Dong; Yiul Lee, Young; Park, Seonyang; Kim, Byung-Kook
Impact of FLT3 receptor tyrosine kinase activation via internal tandem duplication (ITD) of the juxtamembrane region on outcome of acute myeloid leukemia (AML) is still controversial. Recent researches reveal a role of FLT3 in monocyte differentiation in hematopoiesis. We analyzed the clinical impact of FLT3 alterations in adult AML patients excluding acute promyelocytic leukemia (APL) who received induction chemotherapy according to morphologic classification. Retrospective review of medical records from three centers in Korea between 1997 and 2007 was performed. Polymerase chain reaction was performed on genomic DNA derived from blood samples of patients before induction chemotherapy for FLT3-ITD detection. We assessed overall survival (OS), first disease-free survival (1-DFS), and response to induction chemotherapy. One hundred eighty-four patients (median age 49.1 years, range 16.0-76.5) with AML excluding APL received induction chemotherapy from three centers. FLT3-ITD was detected in 22 patients. One hundred forty-one patients were below age 60. One hundred seventy-nine patients received induction chemotherapy with cytarabine and idarubicin (AId) regimen. One hundred nineteen patients achieved complete remission (CR) after first induction chemotherapy. FLT3-ITD was not related to achievement of CR. 1-DFS was longer in patients without FLT3-ITD (median 1-DFS 16.5 vs. 8.5 months, p = 0.025). 1-DFS was not different according to FLT3-ITD status in nonmonocyte lineage leukemia (p = 0.355), while 1-DFS was shorter in monocyte lineage leukemia for FLT3-ITD positive patients (20.9 vs. 2.4 months, p < 0.001). FLT3-ITD had no impact on OS except for monocyte lineage, where OS was significantly shorter in FLT3-ITD positive group (39.4 vs. 6.0 months, p = 0.026). Moreover FLT3-ITD was stronger prognostic factors in monocyte lineage AML than risk stratification based on cytogenetics. Status of FLT3-ITD should be analyzed differently in AML patients according to
Uciteli, Alexandr; Groß, Silvia; Kireyev, Sergej; Herre, Heinrich
This paper presents an ontologically founded basic architecture for information systems, which are intended to capture, represent, and maintain metadata for various domains of clinical and epidemiological research. Clinical trials exhibit an important basis for clinical research, and the accurate specification of metadata and their documentation and application in clinical and epidemiological study projects represents a significant expense in the project preparation and has a relevant impact on the value and quality of these studies.An ontological foundation of an information system provides a semantic framework for the precise specification of those entities which are presented in this system. This semantic framework should be grounded, according to our approach, on a suitable top-level ontology. Such an ontological foundation leads to a deeper understanding of the entities of the domain under consideration, and provides a common unifying semantic basis, which supports the integration of data and the interoperability between different information systems.The intended information systems will be applied to the field of clinical and epidemiological research and will provide, depending on the application context, a variety of functionalities. In the present paper, we focus on a basic architecture which might be common to all such information systems. The research, set forth in this paper, is included in a broader framework of clinical research and continues the work of the IMISE on these topics.
Mishra, Rashmi; Del Fiol, Guilherme; Kilicoglu, Halil; Jonnalagadda, Siddhartha; Fiszman, Marcelo
Clinicians raise several information needs in the course of care. Most of these needs can be met by online health knowledge resources such as UpToDate. However, finding relevant information in these resources often requires significant time and cognitive effort. To design and assess algorithms for extracting from UpToDate the sentences that represent the most clinically useful information for patient care decision making. We developed algorithms based on semantic predications extracted with SemRep, a semantic natural language processing parser. Two algorithms were compared against a gold standard composed of UpToDate sentences rated in terms of clinical usefulness. Clinically useful sentences were strongly correlated with predication frequency (correlation= 0.95). The two algorithms did not differ in terms of top ten precision (53% vs. 49%; p=0.06). Semantic predications may serve as the basis for extracting clinically useful sentences. Future research is needed to improve the algorithms.
Health information systems (HISs) hold the promise to transform health care; however, their adoption is challenged. We have developed the Clinical Adoption Meta-Model (CAMM) to help describe processes and possible challenges with clinical adoption. The CAMM, developed through an action research study to evaluate a provincial HIS, is a temporal model with four dimensions: availability, use, behaviour changes, and outcome changes. Seven CAMM archetypes are described, illustrating classic trajectories of adoption of HISs over time. Each archetype includes an example from the literature. The CAMM and its archetypes can support HIS implementers, evaluators, learners, and researchers. PMID:24884588
According to ethical theories of patient autonomy, patients need information and understanding to make their own, autonomous choices. The aim of this article is to describe strategies used by clinical rehabilitation teams to develop patients' understanding and promote their autonomy. Individual semi-structured interviews were conducted with the patient, the nurse, the physiotherapist and the physician of three institution based rehabilitation teams. Analytic procedures described by Strauss and Corbin were applied, identifying categories by their properties and dimensions. The analysis revealed how practitioners recognized that patients needed experience with practical challenges in order to understand their clinical conditions properly. Practitioners disclosed information related to the individual patient's experience with his or her clinical condition. In order to make information relevant to the individual patient's experience of possibilities and limitations, information was disclosed in discussions of these experiences, rather than in abstract verbal explanations. Patients needed to understand their situation to make autonomous choices for their future lives. In clinical rehabilitation, patients and practitioners agree that adequate understanding cannot be achieved by verbal information alone, and that patients need to experience essential aspects of their physical possibilities and limitations. Patients need an adequate understanding of their injuries or diseases to be able to make autonomous choices. In clinical rehabilitation teams, practical and bodily experiences are recognized as crucial for patients to develop such understanding. Rehabilitation practitioners may effectively enhance a patient's understanding and autonomy by disclosing information as part of discussions of the patient's own experiences.
Pickering, B W; Herasevich, V; Ahmed, A; Gajic, O
The introduction of electronic medical records (EMR) and computerized physician order entry (CPOE) into the intensive care unit (ICU) is transforming the way health care providers currently work. The challenge facing developers of EMR's is to create products which add value to systems of health care delivery. As EMR's become more prevalent, the potential impact they have on the quality and safety, both negative and positive, will be amplified. In this paper we outline the key barriers to effective use of EMR and describe the methodology, using a worked example of the output. AWARE (Ambient Warning and Response Evaluation), is a physician led, electronic-environment enhancement program in an academic, tertiary care institution's ICU. The development process is focused on reducing information overload, improving efficiency and eliminating medical error in the ICU.
Xu, Xizhan; Xiang, Kuanhui; Su, Mingze; Li, Yao; Ji, Wei; Li, Yutang; Zhuang, Hui; Li, Tong
Naturally occurring nucleos(t)ide analogue resistance (NUCr) substitution frequencies in the reverse transcriptase (RT) of the hepatitis B virus (HBV) were studied extensively after the clinical approval of nucleos(t)ide analogues (NUCs; year of approval 1998). We aimed to study NUCr substitutions in HBV RT sequences obtained before 1998 and better understand the evolution of RT sequences without NUC pressures. Our strategy was to retrieve HBV sequences from GenBank deposited before 1998. The initial search used the keywords "hepatitis B virus" or "HBV" and 1139 sequences were found. Data analyses included information extraction: sequence quality control and amino acid substitution analysis on 8 primary NUCr and 3 secondary substitution codons. Three hundred and ninety-four RT-containing sequences of 8 genotypes from 25 countries in 4 continents were selected. Twenty-seven (6.9%) sequences were found to harbor substitutions at NUCr-related codons. Secondary substitutions (rtL80V and rtV173G/A/L) occurred more frequently than primary NUCr substitutions (rtI169L; rtA181G; T184A/S; rtS202T/R; rtM204L and rtM250K). Typical amino acid substitutions associated with NUCr were of rtL80V, rtV173L and rtT184A/S. We confirm the presence of naturally occurring typical HBV NUCr substitutions with very low frequencies, and secondary substitutions are more likely to occur than primary NUCr substitutions without the selective pressure of NUCs.
Moreno-Conde, Alberto; Sanchez-Laguna, Francisco; Marin-Bastida, Bidatzi; Romero-Tabares, Antonio; Martin-Sánchez, Eva; Kalra, Dipak; Parra-Calderón, Carlos Luis
The Andalusian Health Service is the public healthcare provider for 8.302.923 inhabitants in the South Spain. This organization coordinates primary and specialized care with an IT infrastructure composed by multiple Electronic Health Record Systems. According to the large volume of healthcare professionals involved, there is a need for providing a consistent management of information through multiple locations and systems. The HEMIC project aims to address this need developing and validating a methodology based on a software tool for standardizing information contained within EHR systems. The developed tool has been designed for supporting the participation of healthcare professionals the establishment of mechanisms for information governance. This research presents the requirements and designs for of a software tool focused on the adoption of recognized best practice in clinical information modeling. The designed tool has a Service Oriented Architecture that will be able to integrate terminology servers and repositories of clinical information models as part of the modeling process. Moreover, the defined tool organizes clinicians, IT developers and terminology experts involved in the modeling process in three levels to promote their coordination in the definition, specialization and validation of clinical information models. In order to ensure the quality of the developed clinical information models, the defined tool is based on the requirements defined in the ISO13972 Technical Specification.
Lipsman, Nir; Giacobbe, Peter; Bernstein, Mark; Lozano, Andres M
Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.
Sparks, Jesse R.; Katz, Irvin R.; Beile, Penny M.
Digital information literacy (DIL)--generally defined as the ability to obtain, understand, evaluate, and use information in a variety of digital technology contexts--is a critically important skill deemed necessary for success in higher education as well as in the global networked economy. To determine whether college graduates possess the…
Ajiferuke, Isola; Tiamiyu, Mutawakilu; Longe, Folake; Nwagwu, Williams; Ogunsola, Kemi; Opesade, Adeola; Olatokun, Wole
Training programmes for the information professions worldwide have been shifting and diversifying the scope of their claimed domains and curricula in order to empower their graduates with diverse knowledge and versatile technical skills required to compete successfully in the highly competitive job markets in the information industries. In line…
Hammami, Muhammad M; Al-Jawarneh, Yussuf; Hammami, Muhammad B; Al Qadire, Mohammad
The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures. We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners' details, benefits, risks, complications' management, available alternatives, procedure's description, and post-procedure's issues. Respondents' mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee's name). Overall, items related to benefits and post-procedure's issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure's name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009). 1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure's issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more
Julé, Amélie; Furtado, Tamzin; Boggs, Liam; van Loggerenberg, Francois; Ewing, Victoria; Vahedi, Manhaz; Launois, Pascal; Lang, Trudie
Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas-(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally.
Wong, David; Wu, Nicolas; Watkinson, Peter
We introduce a novel quantitative approach for evaluating the order of roll-out during phased introduction of clinical information systems. Such roll-outs are associated with unavoidable risk due to patients transferring between clinical areas using both the old and new systems. We proposed a simple graphical model of patient flow through a hospital. Using a simple instance of the model, we showed how a roll-out order can be generated by minimising the flow of patients from the new system to the old system. The model was applied to admission and discharge data acquired from 37,080 patient journeys at the Churchill Hospital, Oxford between April 2013 and April 2014. The resulting order was evaluated empirically and produced acceptable orders. The development of data-driven approaches to clinical Information system roll-out provides insights that may not necessarily be ascertained through clinical judgment alone. Such methods could make a significant contribution to the smooth running of an organisation during the roll-out of a potentially disruptive technology. Unlike previous approaches, which are based on clinical opinion, the approach described here quantitatively assesses the appropriateness of competing roll-out strategies. The data-driven approach was shown to produce strategies that matched clinical intuition and provides a flexible framework that may be used to plan and monitor Clinical Information System roll-out. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.
El Emam, Khaled; Moreau, Katherine; Jonker, Elizabeth
Findings and statements about how securely personal health information is managed in clinical research are mixed. The objective of our study was to evaluate the security of practices used to transfer and share sensitive files in clinical trials. Two studies were performed. First, 15 password-protected files that were transmitted by email during regulated Canadian clinical trials were obtained. Commercial password recovery tools were used on these files to try to crack their passwords. Second, interviews with 20 study coordinators were conducted to understand file-sharing practices in clinical trials for files containing personal health information. We were able to crack the passwords for 93% of the files (14/15). Among these, 13 files contained thousands of records with sensitive health information on trial participants. The passwords tended to be relatively weak, using common names of locations, animals, car brands, and obvious numeric sequences. Patient information is commonly shared by email in the context of query resolution. Files containing personal health information are shared by email and, by posting them on shared drives with common passwords, to facilitate collaboration. If files containing sensitive patient information must be transferred by email, mechanisms to encrypt them and to ensure that password strength is high are necessary. More sophisticated collaboration tools are required to allow file sharing without password sharing. We provide recommendations to implement these practices.
Flynn, Maura G
BACKGROUND: Hospital clinicians are increasingly expected to practice evidence-based medicine (EBM) in order to minimize medical errors and ensure quality patient care, but experience obstacles to information-seeking. The introduction of a Clinical Informationist (CI) is explored as a possible solution. AIMS: This paper investigates the self-perceived information needs, behaviour and skill levels of clinicians in two Irish public hospitals. It also explores clinicians\\' perceptions and attitudes to the introduction of a CI into their clinical teams. METHODS: A questionnaire survey approach was utilised for this study, with 22 clinicians in two hospitals. Data analysis was conducted using descriptive statistics. RESULTS: Analysis showed that clinicians experience diverse information needs for patient care, and that barriers such as time constraints and insufficient access to resources hinder their information-seeking. Findings also showed that clinicians struggle to fit information-seeking into their working day, regularly seeking to answer patient-related queries outside of working hours. Attitudes towards the concept of a CI were predominantly positive. CONCLUSION: This paper highlights the factors that characterise and limit hospital clinicians\\' information-seeking, and suggests the CI as a potentially useful addition to the clinical team, to help them to resolve their information needs for patient care.
Banzi, Rita; González-Lorenzo, Marien; Kwag, Koren Hyogene; Bonovas, Stefanos; Moja, Lorenzo
Evidence-based healthcare requires the integration of the best research evidence with clinical expertise and patients' values. International publishers are developing evidence-based information services and resources designed to overcome the difficulties in retrieving, assessing and updating medical information as well as to facilitate a rapid access to valid clinical knowledge. Point-of-care information summaries are defined as web-based medical compendia that are specifically designed to deliver pre-digested, rapidly accessible, comprehensive, and periodically updated information to health care providers. Their validity must be assessed against marketing claims that they are evidence-based. We periodically evaluate the content development processes of several international point-of-care information summaries. The number of these products has increased along with their quality. The last analysis done in 2014 identified 26 products and found that three of them (Best Practice, Dynamed e Uptodate) scored the highest across all evaluated dimensions (volume, quality of the editorial process and evidence-based methodology). Point-of-care information summaries as stand-alone products or integrated with other systems, are gaining ground to support clinical decisions. The choice of one product over another depends both on the properties of the service and the preference of users. However, even the most innovative information system must rely on transparent and valid contents. Individuals and institutions should regularly assess the value of point-of-care summaries as their quality changes rapidly over time.
Margolis, S.; Baker, T.G.; Ritchey, M.G.; Alterescu, S.; Friedman, C.
This paper describes an automated medical information management system within a clinic setting. The system includes an optically scanned data entry system (OpScan), a generalized, interactive retrieval and storage software system(Medical Information Management System, MIMS) and the use of time-sharing. The system has the advantages of minimal hardware purchase and maintenance, rapid data entry and retrieval, user-created programs, no need for user knowledge of computer language or technology and is cost effective. The OpScan-MIMS system has been operational for approximately 16 months in a sexually transmitted disease clinic. The system's application to medical audit, quality assurance, clinic management and clinical training are demonstrated.
Garson, A. B., III; Allen, B.; Baker, R. G.; Barthelmy, S. D.; Burke, M.; Burnham, J.; Chammas, N.; Collins, J.; Cook, W. R.; Copete, A.; Gehrels, N.; Gauron, T.; Grindlay, J.; Harrison, F. A.; Hong, J.; Howell, J.; Krawczynski, H.; Labov, S.; Said, B.; Sheikh Sheikh, S.
We describe the ProtoEXIST instrument, our fist-generation wide-field hard X-ray imaging (20 - 600 keV) balloon-borne telescope. The ProtoEXIST program is a pathfinder for the Energetic X-ray Imaging Survey Telescope (EXIST), a candidate for the Black Hole Finder Probe. ProtoEXIST consists of two independent coded-aperture telescopes using pixellated (2.5mm pitch) CZT detectors. The two telescopes will provide performance comparison of two shielding configurations, for optimization of the EXIST design. We report on the science goals and designs of both ProtoEXIST and EXIST and their implications for hard X-ray astronomy and astrophysics.
Wright, Adam; Sittig, Dean F
A new architecture for clinical decision support called SANDS (Service-oriented Architecture for NHIN Decision Support) is introduced and its performance evaluated. The architecture provides a method for performing clinical decision support across a network, as in a health information exchange. Using the prototype we demonstrated that, first, a number of useful types of decision support can be carried out using our architecture; and, second, that the architecture exhibits desirable reliability and performance characteristics.
Downing, Gregory J; Boyle, Scott N; Brinner, Kristin M; Osheroff, Jerome A
Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies. Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures), and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine. This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In addition, to represent meaningful benefits to personalized
Brinner Kristin M
Full Text Available Abstract Background Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies. Discussion Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures, and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine. Summary This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In
Beck, Peter; Truskaller, Thomas; Rakovac, Ivo; Bruner, Fritz; Zanettin, Dominik; Pieber, Thomas R
5.9% of the Austrian population is affected by diabetes mellitus. Disease Management is a structured treatment approach that is suitable for application to the diabetes mellitus area and often is supported by information technology. This article describes the information systems developed and implemented in the Austrian disease management programme for type 2 diabetes. Several workflows for administration as well as for clinical documentation have been implemented utilizing the Austrian e-Health infrastructure. De-identified clinical data is available for creating feedback reports for providers and programme evaluation.
Lopes, António M; Machado, J A Tenreiro; Galhano, Alexandra M
This paper addresses the visualization of complex information using multidimensional scaling (MDS). MDS is a technique adopted for processing data with multiple features scattered in high-dimensional spaces. For illustrating the proposed techniques, the case of viral diseases is considered. The study evaluates the characteristics of 21 viruses in the perspective of clinical information. Several new schemes are proposed for improving the visualization of the MDS charts. The results follow standard clinical practice, proving that the method represents a valuable tool to study a large number of viruses.
Hosseini, Masoud; Jones, Josette; Faiola, Anthony; Vreeman, Daniel J; Wu, Huanmei; Dixon, Brian E
Due to the nature of information generation in health care, clinical documents contain duplicate and sometimes conflicting information. Recent implementation of Health Information Exchange (HIE) mechanisms in which clinical summary documents are exchanged among disparate health care organizations can proliferate duplicate and conflicting information. To reduce information overload, a system to automatically consolidate information across multiple clinical summary documents was developed for an HIE network. The system receives any number of Continuity of Care Documents (CCDs) and outputs a single, consolidated record. To test the system, a randomly sampled corpus of 522 CCDs representing 50 unique patients was extracted from a large HIE network. The automated methods were compared to manual consolidation of information for three key sections of the CCD: problems, allergies, and medications. Manual consolidation of 11,631 entries was completed in approximately 150h. The same data were automatically consolidated in 3.3min. The system successfully consolidated 99.1% of problems, 87.0% of allergies, and 91.7% of medications. Almost all of the inaccuracies were caused by issues involving the use of standardized terminologies within the documents to represent individual information entries. This study represents a novel, tested tool for de-duplication and consolidation of CDA documents, which is a major step toward improving information access and the interoperability among information systems. While more work is necessary, automated systems like the one evaluated in this study will be necessary to meet the informatics needs of providers and health systems in the future. Copyright © 2017 Elsevier Inc. All rights reserved.
McCann, Liza J; Arnold, Katie; Pilkington, Clarissa A; Huber, Adam M; Ravelli, Angelo; Beard, Laura; Beresford, Michael W; Wedderburn, Lucy R
Juvenile dermatomyositis (JDM) is a rare but severe autoimmune inflammatory myositis of childhood. International collaboration is essential in order to undertake clinical trials, understand the disease and improve long-term outcome. The aim of this study was to propose from existing collaborative initiatives a preliminary minimal dataset for JDM. This will form the basis of the future development of an international consensus-approved minimum core dataset to be used both in clinical care and inform research, allowing integration of data between centres. A working group of internationally-representative JDM experts was formed to develop a provisional minimal dataset. Clinical and laboratory variables contained within current national and international collaborative databases of patients with idiopathic inflammatory myopathies were scrutinised. Judgements were informed by published literature and a more detailed analysis of the Juvenile Dermatomyositis Cohort Biomarker Study and Repository, UK and Ireland. A provisional minimal JDM dataset has been produced, with an associated glossary of definitions. The provisional minimal dataset will request information at time of patient diagnosis and during on-going prospective follow up. At time of patient diagnosis, information will be requested on patient demographics, diagnostic criteria and treatments given prior to diagnosis. During on-going prospective follow-up, variables will include the presence of active muscle or skin disease, major organ involvement or constitutional symptoms, investigations, treatment, physician global assessments and patient reported outcome measures. An internationally agreed minimal dataset has the potential to significantly enhance collaboration, allow effective communication between groups, provide a minimal standard of care and enable analysis of the largest possible number of JDM patients to provide a greater understanding of this disease. This preliminary dataset can now be developed into
Bergenmar, Mia; Johansson, Hemming; Wilking, Nils; Hatschek, Thomas; Brandberg, Yvonne
Patient information in cancer clinical trial is challenging. The value of audio-recording interventions for patients considering participating in clinical trials is unclear. The primary aim of this randomized study was to investigate effects of audio-recorded information on knowledge and understanding in patients considering participation in a clinical trial. Patients scheduled for information about a phases 2 or 3 trial by one of the 13 participating oncologists at the Department of Oncology during the study period (2008-2013) were eligible. The intervention consisted of an audio-recording on compact disc (CD) of the information at the medical consultation in which the patients were informed about a trial. Knowledge and understanding was measured by the questionnaire, Quality of Informed Consent. A total of 130 patients were randomized, 70% of the calculated sample size (n = 186). Sixty-seven patients were randomized to the intervention. In total, 101 patients (78%) completed questionnaires. No statistical significant differences were found between the groups with respect to knowledge and understanding. The level of knowledge was relatively high, with the exceptions of the risks associated with, and the unproven nature of, the trial. Overall, patients who declined participation scored statistically significant lower on knowledge. The present study was underpowered and the results should therefore be interpreted with caution. Still, 130 patients were included with a response rate of 78%. A CD including the oral information about a clinical trial did not show any effects on knowledge or understanding. However, the levels of knowledge were high, possible due to the high levels of education in the study group. Information on risks associated with the trial is still an area for improvement.
Viitanen, Johanna; Nieminen, Marko; Hypponen, Hannele; Laaveri, Tinja
Several researchers share the concern of healthcare information systems failing to support communication and collaboration in clinical practices. The objective of this paper is to investigate the current state of computer-supported patient information exchange and associated communication between clinicians. We report findings from a national survey on Finnish physicians? experiences with their currently used clinical information systems with regard to patient information documentation, retrieval, management and exchange-related tasks. The questionnaire study with 3929 physicians indicated the main concern being cross-organisational patient information delivery. In addition, physicians argued computer usage increasingly steals time and attention from caring activities and even disturbs physician?nurse collaboration. Problems in information management were particularly emphasised among those physicians working in hospitals and wards. The survey findings indicated that collaborative applications and mobile or wireless solutions have not been widely adapted in Finnish healthcare and suggested an urgent need for adopting appropriate information and communication technology applications to support information exchange and communication between physicians, and physicians and nurses.
Bradley D. Gordon
Full Text Available Introduction: The objective of the study was to understand the immediate utility of health information exchange (HIE on emergency department (ED providers by interviewing them shortly after the information was retrieved. Prior studies of physician perceptions regarding HIE have only been performed outside of the care environment. Methods: Trained research assistants interviewed resident physicians, physician assistants and attending physicians using a semi-structured questionnaire within two hours of making a HIE request. The responses were recorded, then transcribed for qualitative analysis. The transcribed interviews were analyzed for emerging qualitative themes. Results: We analyzed 40 interviews obtained from 29 providers. Primary qualitative themes discovered included the following: drivers for requests for outside information; the importance of unexpected information; historical lab values as reference points; providing context when determining whether to admit or discharge a patient; the importance of information in refining disposition; improved confidence of provider; and changes in decisions for diagnostic imaging. Conclusion: ED providers are driven to use HIE when they’re missing a known piece of information. This study finds two additional impacts not previously reported. First, providers sometimes find additional unanticipated useful information, supporting a workflow that lowers the threshold to request external information. Second, providers sometimes report utility when no changes to their existing plan are made as their confidence is increased based on external records. Our findings are concordant with previous studies in finding exchanged information is useful to provide context for interpreting lab results, making admission decisions, and prevents repeat diagnostic imaging.
Konstantinidis, Georgios; Anastassopoulos, George C; Karakos, Alexandros S; Anagnostou, Emmanouil; Danielides, Vasileios
The aim of this study is to present our perspectives on healthcare analysis and design and the lessons learned from our experience with the development of a distributed, object-oriented Clinical Information System (CIS). In order to overcome known issues regarding development, implementation and finally acceptance of a CIS by the physicians we decided to develop a novel object-oriented methodology by integrating usability principles and techniques in a simplified version of a well established software engineering process (SEP), the Unified Process (UP). A multilayer architecture has been defined and implemented with the use of a vendor application framework. Our first experiences from a pilot implementation of our CIS are positive. This approach allowed us to gain a socio-technical understanding of the domain and enabled us to identify all the important factors that define both the structure and the behavior of a Health Information System.
Leu, Michael G; Cheung, Ming; Webster, Tashonna R; Curry, Leslie; Bradley, Elizabeth H; Fifield, Judith; Burstin, Helen
Clinicians in ambulatory care settings are increasingly called upon to use health information technology (health IT) to improve practice efficiency and performance. Successful adoption of health IT requires an understanding of how clinical tasks and workflows will be affected; yet this has not been well described. To describe how health IT functions within a clinical context. Qualitative study, using in-depth, semi-structured interviews. Executives and staff at 4 community health centers, 3 health center networks, and 1 large primary care organization. Transcribed audio-recorded interviews, analyzed using the constant comparative method. Systematic characterization of clinical context identified 6 primary clinical domains. These included results management, intra-clinic communication, patient education and outreach, inter-clinic coordination, medication management, and provider education and feedback. We generated clinical process diagrams to characterize these domains. Participants suggested that underlying workflows for these domains must be fully operational to ensure successful deployment of health IT. Understanding the clinical context is a necessary precursor to successful deployment of health IT. Process diagrams can serve as the basis for EHR certification, to identify challenges, to measure health IT adoption, or to develop curricular content regarding the role of health IT in clinical practice.
Merritt, Earl S.; Heitkemper, Lawrence; Marcus, Kevin
Global agricultural production information is the key to many economic decisions. National level planners use it to plan imports or to assess balance of payments, farmers use it to make planting decisions, lending and aid institutions use it to plan loans and aid needs, commodity buyers use it to plan purchases. Traditional information systems are slow, offer little confidence and may be inaccurate; systems based on the use of space remote sensor systems are, on the other hand, fast, provide good confidence and are demonstrating improving accuracies. The system structure for remote sensor assisted agricultural information systems is centered on a geobased structure, mapped outputs pinpoint locations where plant stress is impacting yields. Meteorological satellite assessments pinpoint where rainfall and significant solar radiation is impacting the plant environment. The CROPCAST Agricultural Information System offers an opportunity to examine an operating system which contains characteristics essential to all future systems. CROPCAST's use of a grid/cell geobased structure provides a mechanism to effectively use remote-sensor derived data of all types, i.e., Landsats, metsats, aircraft and human eyeball derived data. Predictive models operating in CROPCAST provide updated agricultural assessments in the time intervals when no Landsat or other field observation data are available. Economic models provide the opportunity to merge CROPCAST diagnostic and predictive output with the market place at both the cash and futures level. This presentation will examine the CROPCAST structure as a model for future uses of remote sensing data from civil remote sensing systems in assessing global agricultural production. A review of the future direction to be taken by the CROPCAST System will be included to identify new avenues for remote sensor-based agricultural information system growth over the coming decade of change in remote sensor systems.
Liebe, J D; Hübner, U; Straede, M C; Thye, J
Availability and usage of individual IT applications have been studied intensively in the past years. Recently, IT support of clinical processes is attaining increasing attention. The underlying construct that describes the IT support of clinical workflows is clinical information logistics. This construct needs to be better understood, operationalised and measured. It is therefore the aim of this study to propose and develop a workflow composite score (WCS) for measuring clinical information logistics and to examine its quality based on reliability and validity analyses. We largely followed the procedural model of MacKenzie and colleagues (2011) for defining and conceptualising the construct domain, for developing the measurement instrument, assessing the content validity, pretesting the instrument, specifying the model, capturing the data and computing the WCS and testing the reliability and validity. Clinical information logistics was decomposed into the descriptors data and information, function, integration and distribution, which embraced the framework validated by an analysis of the international literature. This framework was refined selecting representative clinical processes. We chose ward rounds, pre- and post-surgery processes and discharge as sample processes that served as concrete instances for the measurements. They are sufficiently complex, represent core clinical processes and involve different professions, departments and settings. The score was computed on the basis of data from 183 hospitals of different size, ownership, location and teaching status. Testing the reliability and validity yielded encouraging results: the reliability was high with r(split-half) = 0.89, the WCS discriminated between groups; the WCS correlated significantly and moderately with two EHR models and the WCS received good evaluation results by a sample of chief information officers (n = 67). These findings suggest the further utilisation of the WCS. As the WCS does not
Coffey, Sean; Harper, Andrew R; Cairns, Benjamin J; Roberts, Ian Sd; Prendergast, Bernard D
Accuracy of routinely collected information concerning cause of death is essential for public health and health systems planning. Since clinical examination has relatively low sensitivity for detection of valvular heart disease (VHD), mortality data based on clinical information alone might routinely underestimate the number of deaths due to VHD. We compared autopsy findings against premortem clinical information for 8198 consecutive adult postmortems (mean age 69.1 years, 61.3% men), performed in a single UK tertiary referral centre with on-site cardiac surgical facilities over a 10-year period (2004-2013) during which 21% of the adult population underwent postmortem examination. Following postmortem, VHD was the principal cause of death in 165 individuals (2.0%), a principal or contributory cause ('any cause') of death in 326 (4.0%) and an incidental (ie, non-causal) finding in a further 346 (4.2%). Clinical documentation of VHD before death was highly specific but relatively insensitive for postmortem identification of VHD as the principal (specificity 96.8%; 95% CI 96.4% to 97.2%; sensitivity 69.7%, 95% CI 62.1% to 76.6%) or any (specificity 98.1%; 95% CI 97.8% to 98.4%; sensitivity 68.4%, 95% CI 63.1% to 73.4%) cause of death. VHD (principally aortic stenosis, endocarditis and rheumatic heart disease) was newly noted at postmortem and listed as a cause of death in 142 individuals (1.7%). Clinical information recorded premortem is highly specific but relatively insensitive for the cause of death established at autopsy. Population-based mortality statistics that depend on premortem clinical information are likely to routinely underestimate the mortality burden of VHD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Obwegeser, Hugo L; Obwegeser, Joachim A
This is the first description of a secondary mandibular overgrowth due to condylar misregulation in a congenitally undergrown mandible. This case of unilateral hemifacial microsomia proves the postulated existence (Mandibular Growth Anomalies: Terminology, Aetiology, Diagnosis, Treatment, 2001) of 2 different growth regulators in the condyle of each side of the mandible. It shows clear and typical symptoms of hemimandibular hyperplasia on its right side and of hemimandibular elongation on its left mandible despite the existence of a well-developed hemifacial microsomia on the same side. Correction was carried out on the basis of our routine planning and planning principles, including condylectomy on the side of the hemifacial microsomia, because of still active hemimandibular elongation.
Benson, M; Junger, A; Quinzio, L; Michel, A; Sciuk, G; Fuchs, C; Marquardt, K; Hempelmannn, G
Anesthesia Information Management Systems (AIMS) are required to supply large amounts of data for various purposes such as performance recording, quality assurance, training, operating room management and research. It was our objective to establish an AIMS that enables every member of the department to independently access queries at his/her work station and at the same time allows the presentation of data in a suitable manner in order to increase the transfer of different information to the clinical workstation. Apple Macintosh Clients (Apple Computer, Inc. Cupertino, California) and the file- and database servers were installed into the already partially existing hospital network. The most important components installed on each computer are the anesthesia documenting software NarkoData (ProLogic GmbH, Erkrath), HIS client software and a HTML browser. More than 250 queries for easy evaluation were formulated with the software Voyant (Brossco Systems, Espoo, Finland). Together with the documentation they are the evaluation module of the AIMS. Today, more than 20,000 anesthesia procedures are recorded each year at 112 decentralised workstations with the AIMS. In 1998, 90.8% of the 20,383 performed anesthetic procedures were recorded online and 9.2% entered postopeatively into the system. With a corresponding user access it is possible to receive all available patient data at each single anesthesiological workstation via HIS (diagnoses, laboratory results) anytime. The available information includes previous anesthesia records, statistics and all data available from the hospitals intranet. This additional information is of great advantage in comparison to previous working conditions. The implementation of an AIMS allowed to greatly enhance the quota but also the quality of documentation and an increased flow of information at the anesthesia workstation. The circuit between data entry and the presentation and evaluation of data, statistics and results directly
Hernández, Astrid; Baños, Josep-E.; Llop, Cristina; Farré, Magí
Aim Lack of knowledge concerning the nature of placebo and why it is necessary may influence the participation of patients in clinical trials. The objective of the present study is to review how placebo is described in written information for participants in clinical trials to be evaluated by a Human Research Ethics Committee. Methods All research protocols submitted for evaluation in a Spanish hospital during 2007–2013 were reviewed. The main characteristics of the studies using a placebo were collected. Three authors read each of them to determine how the term “placebo” was explained and if there was any comment on its efficacy and safety. Results Two thousand seven-hundred and forty research protocols were evaluated, of which three hundred and fifty-nine used a placebo. Pharmaceutical companies sponsored most placebo-controlled clinical trials (91.9%), and phase III studies were the commonest (59.9%). Oncology (15.0%), cardiology (14.2%), and neurology (13.1%) made the greatest contributions. A review of the informed consent forms showed that placebo was described in a similar manner in most studies: the explanation was limited to between four and eight words. Very few gave information about the risks of its use or adverse reactions from its administration. None of the studies provided details about the placebo effect. And 23 lacked any information about placebo at all. Conclusions Explanations about placebo in informed consent forms is often scarce, and information about the placebo effect and associated risks are absent. This situation may influence a full understanding of placebo by participants in clinical trials and might reduce their informed decision to participate. PMID:25423149
Navare, Jyoti; Gemikonakli, Orhan
Globalisation and new technology has opened the gates to more security risks. As the strategic importance of communication networks and information increased, threats to the security and safety of communication infrastructures, as well as information stored in and/or transmitted increased significantly. The development of the self replicating programmes has become a nightmare for Internet users. Leading companies, strategic organisations were not immune to attacks; they were also "hacked" and overtaken by intruders. Incidents of recent years have also shown that national/regional crisis may also trigger cyber attacks at large scale. Experts forecast that cyber wars are likely to take the stage as tension mounts between developed societies. New risks such as cyber-attacks, network terrorism and disintegration of traditional infrastructures has somewhat blurred the boundaries of operation and control. This paper seeks to consider the risk management and governance and looking more specifically at implications for emerging economies.
The Nuclear Materials Storage Facility (NMSF) at the Los Alamos National Laboratory (LANL) was a Fiscal Year (FY) 1984 line-item project completed in 1987 that has never been operated because of major design and construction deficiencies. This renovation project, which will correct those deficiencies and allow operation of the facility, is proposed as an FY 97 line item. The mission of the project is to provide centralized intermediate and long-term storage of special nuclear materials (SNM) associated with defined LANL programmatic missions and to establish a centralized SNM shipping and receiving location for Technical Area (TA)-55 at LANL. Based on current projections, existing storage space for SNM at other locations at LANL will be loaded to capacity by approximately 2002. This will adversely affect LANUs ability to meet its mission requirements in the future. The affected missions include LANL`s weapons research, development, and testing (WRD&T) program; special materials recovery; stockpile survelliance/evaluation; advanced fuels and heat sources development and production; and safe, secure storage of existing nuclear materials inventories. The problem is further exacerbated by LANL`s inability to ship any materials offsite because of the lack of receiver sites for mate rial and regulatory issues. Correction of the current deficiencies and enhancement of the facility will provide centralized storage close to a nuclear materials processing facility. The project will enable long-term, cost-effective storage in a secure environment with reduced radiation exposure to workers, and eliminate potential exposures to the public. Based upon US Department of Energy (DOE) Albuquerque Operations (DOE/Al) Office and LANL projections, storage space limitations/restrictions will begin to affect LANL`s ability to meet its missions between 1998 and 2002.
Burn, Katharine; Mutton, Trevor
This review examines the kinds of relationship between research and practice that have been envisaged in programmes designed to provide opportunities for beginning teachers to engage in "research-informed clinical practice". Although the terminology varies, scope for inclusion is defined by an intention to facilitate and deepen the…
This study compares quality measures among nursing homes that have adopted different levels of clinical health information technology (HIT) and examines the perceived barriers and benefits of the adoption of electronic health records as reported by Nursing Home Administrators and Directors of Nursing. A cross-sectional survey distributed online to…
... clinical studies not conducted under an IND as support for an IND or application for marketing approval for... study as support for an IND or application for marketing approval must provide the following information... detailed summary of the protocol and results of the study and, should FDA request, case records maintained...
Kampen, D.A. van
In this thesis we investigated the use of clinical information and Patient Reported Outcome Measures (PROMs) for patient evaluation in orthopaedic surgery and sports medicine. In the first part, we showed that the Dutch version of the Simple Shoulder Test (SST) is a valid and reliable
Full Text Available BACKGROUND: Quantitative tools have been developed to evaluate the readability of written documents and have been used in several studies to evaluate information and consent forms. These studies all showed that such documents had a low level of readability. Our objective is to evaluate the readability of Information and Consent Forms (ICFs used in clinical research. METHODS AND FINDINGS: Clinical research protocols were collected from four public clinical research centers in France. Readability was evaluated based on three criteria: the presence of an illustration, the length of the text and its Flesch score. Potential effects of protocol characteristics on the length and readability of the ICFs were determined. Medical and statutory parts of the ICF form were analyzed separately. The readability of these documents was compared with that of everyday contracts, press articles, literary extracts and political speeches. We included 209 protocols and the corresponding 275 ICFs. The median length was 1304 words. Their Flesch readability scores were low (median: 24, and only about half that of selected press articles. ICF s for industrially sponsored and randomized protocols were the longest and had the highest readability scores. More than half (52% of the text in ICFs concerned medical information, and this information was statistically (p<0.05 more readable (Flesch: 28 than statutory information (Flesch: 21. CONCLUSION: Regardless of the field of research, the ICFs for protocols included had poor readability scores. However, a prospective analysis of this test in French should be carried out before it is put into general use.
Rescorla, Leslie A; Ewing, Grace; Ivanova, Masha Y
To conduct international comparisons of parent-adolescent cross-informant agreement in clinical samples, we analyzed ratings on the Child Behavior Checklist (CBCL) and Youth Self-Report (YSR) for 6,762 clinically referred adolescents ages 11-18 from 7 societies (M = 14.5 years, SD = 2.0 years; 51......% boys). Using CBCL and YSR data, we asked the following questions: (a) Do parents report more problems for their adolescent children than the adolescents report about themselves? (b) How do cross-informant correlations (rs) for scale scores differ by problem type and by society? (c) How well do parents...... and adolescents, on average, agree regarding which problems they rate as low, medium, or high? (d) How does within-dyad item agreement vary within and between societies? (e) How do societies vary in dichotomous cross-informant agreement with respect to the deviance status of the adolescents? CBCL and YSR scores...
Kim, Junetae; Lee, Yura; Lim, Sanghee; Kim, Jeong Hoon; Lee, Byungtae; Lee, Jae-Ho
There has been a lack of understanding on what types of specific clinical information are most valuable for doctors to access through mobile-based electronic medical records (m-EMRs) and when they access such information. Furthermore, it has not been clearly discussed why the value of such information is high. The goal of this study was to investigate the types of clinical information that are most valuable to doctors to access through an m-EMR and when such information is accessed. Since 2010, an m-EMR has been used in a tertiary hospital in Seoul, South Korea. The usage logs of the m-EMR by doctors were gathered from March to December 2015. Descriptive analyses were conducted to explore the overall usage patterns of the m-EMR. To assess the value of the clinical information provided, the usage patterns of both the m-EMR and a hospital information system (HIS) were compared on an hourly basis. The peak usage times of the m-EMR were defined as continuous intervals having normalized usage values that are greater than 0.5. The usage logs were processed as an indicator representing specific clinical information using factor analysis. Random intercept logistic regression was used to explore the type of clinical information that is frequently accessed during the peak usage times. A total of 524,929 usage logs from 653 doctors (229 professors, 161 fellows, and 263 residents; mean age: 37.55 years; males: 415 [63.6%]) were analyzed. The highest average number of m-EMR usage logs (897) was by medical residents, whereas the lowest (292) was by surgical residents. The usage amount for three menus, namely inpatient list (47,096), lab results (38,508), and investigation list (25,336), accounted for 60.1% of the peak time usage. The HIS was used most frequently during regular hours (9:00 AM to 5:00 PM). The peak usage time of the m-EMR was early in the morning (6:00 AM to 10:00 AM), and the use of the m-EMR from early evening (5:00 PM) to midnight was higher than during regular
Puente, Antonio E.; And Others
Claims little information exists in undergraduate education about clinical neuropsychology. Outlines an undergraduate neuropsychology course and proposes ways to integrate the subject into existing undergraduate psychology courses. Suggests developing specialized audio-visual materials for telecourses or existing courses. (NL)
Existing Analytical Frameworks for Information Behaviour Don’t Fully Explain HIV/AIDS Information Exchange in Rural Communities in Ontario, Canada. A Review of: Veinot, T., Harris, R., Bella, L., Rootman, I., & Krajnak, J. (2006. HIV/AIDS Information exchange in rural communities: Preliminary findings from a three‐province study. Canadian Journal of Information and Library Science, 30(3/4, 271‐290.
its presence supersedes the professional role of the provider (social workers and counsellors were identified as key information sources over medical professionals in this instance. Participants responded negatively to the perceived lack of support from providers including doubting the information provided.•PHAs monitor their worlds and keep up to date about HIV/AIDS.Inconsistent with theories:•Reliance on caregivers for information is not solely explained by fear of stigma or exposure. Rather, it is the specialized knowledge and immersion in HIV/AIDS which is valued.•The distinction between peer or kin sources of information and institutional information sources is less clear and relationships with professionals can turn personal over time.•Inter‐personal connections include organisations, not just individuals, particularly AIDS Service Organizations and HIV specialist clinics.•Relatively few incidents of finding useful information about HIV/AIDS incidentally were described. The concept of information just being “out there” was not really applicable to rural settings, likely due to the lack of discussion within participant communities and local media. When it was discussed, participants reported being more likely to gain misinformation through their personal networks.•Incidental information acquisition originates mostly from professional and organisational sources. Participants identified posters, leaflets, and, for those who interacted with organisations, information via mail as contributing to current awareness.•The gate keeping concept does not capture all the information sharing activities undertaken by “gate keepers” in rural areas, and neither does it include formal providers of information, yet all PHAs interviewed identified formal providers as key sources.Conclusion – The findings reinforce some of the existing analytical framework theories, particularly the importance of affective components (i.e. emotional supports of information
Barrett, James E
Selective recruitment designs preferentially recruit individuals who are estimated to be statistically informative onto a clinical trial. Individuals who are expected to contribute less information have a lower probability of recruitment. Furthermore, in an information-adaptive design, recruits are allocated to treatment arms in a manner that maximises information gain. The informativeness of an individual depends on their covariate (or biomarker) values, and how information is defined is a critical element of information-adaptive designs. In this paper, we define and evaluate four different methods for quantifying statistical information. Using both experimental data and numerical simulations, we show that selective recruitment designs can offer a substantial increase in statistical power compared with randomised designs. In trials without selective recruitment, we find that allocating individuals to treatment arms according to information-adaptive protocols also leads to an increase in statistical power. Consequently, selective recruitment designs can potentially achieve successful trials using fewer recruits thereby offering economic and ethical advantages. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.
Chen, Maggie H; Willan, Andrew R
Most often, sample size determinations for randomized clinical trials are based on frequentist approaches that depend on somewhat arbitrarily chosen factors, such as type I and II error probabilities and the smallest clinically important difference. As an alternative, many authors have proposed decision-theoretic (full Bayesian) approaches, often referred to as value of information methods that attempt to determine the sample size that maximizes the difference between the trial's expected utility and its expected cost, referred to as the expected net gain. Taking an industry perspective, Willan proposes a solution in which the trial's utility is the increase in expected profit. Furthermore, Willan and Kowgier, taking a societal perspective, show that multistage designs can increase expected net gain. The purpose of this article is to determine the optimal sample size using value of information methods for industry-based, multistage adaptive randomized clinical trials, and to demonstrate the increase in expected net gain realized. At the end of each stage, the trial's sponsor must decide between three actions: continue to the next stage, stop the trial and seek regulatory approval, or stop the trial and abandon the drug. A model for expected total profit is proposed that includes consideration of per-patient profit, disease incidence, time horizon, trial duration, market share, and the relationship between trial results and probability of regulatory approval. The proposed method is extended to include multistage designs with a solution provided for a two-stage design. An example is given. Significant increases in the expected net gain are realized by using multistage designs. The complexity of the solutions increases with the number of stages, although far simpler near-optimal solutions exist. The method relies on the central limit theorem, assuming that the sample size is sufficiently large so that the relevant statistics are normally distributed. From a value of
Maupomé, Gerardo; Schrader, Stuart; Mannan, Saurabh; Garetto, Lawrence; Eggertsson, Hafsteinn
It is uncertain whether the range and frequency of Diagnostic Thinking Processes (DTP) and pieces of information (concepts) involved in dental restorative treatment planning are different between students and expert clinicians. We video-recorded dental visits with one standardized patient. Clinicians were subsequently interviewed and their cognitive strategies explored using guide questions; interviews were also recorded. Both visit and interview were content-analyzed, following the Gale and Marsden model for clinical decision-making. Limited tests used to contrast data were t, chi2, and Fisher's. Scott's pi was used to determine inter-coder reliability. Fifteen dentists and 17 senior dental students participated in visits lasting 32.0 minutes (+/- 12.9) among experts, and 29.9 +/- 7.1 among students; contact time with patient was 26.4 +/- 13.9 minutes (experts), and 22.2 +/- 7.5 (students). The time elapsed between the first and the last instances of the clinician looking in the mouth was similar between experts and students. Ninety eight types of pieces of information were used in combinations with 12 DTPs. The main differences found in DTP utilization had dentists conducting diagnostic interpretations of findings with sufficient certainty to be considered definitive twice as often as students. Students resorted more often to more general or clarifying enquiry in their search for information than dentists. Differences in diagnostic strategies and concepts existed within clearly delimited types of cognitive processes; such processes were largely compatible with the analytic and (in particular) non-analytic approaches to clinical decision-making identified in the medical field. Because we were focused on a clinical presentation primarily made up of non-emergency treatment needs, use of other DTPs and concepts might occur when clinicians evaluate emergency treatment needs, complex rehabilitative cases, and/or medically compromised patients.
Scuba, William; Tharp, Melissa; Mowery, Danielle; Tseytlin, Eugene; Liu, Yang; Drews, Frank A; Chapman, Wendy W
Clinical Natural Language Processing (NLP) systems require a semantic schema comprised of domain-specific concepts, their lexical variants, and associated modifiers to accurately extract information from clinical texts. An NLP system leverages this schema to structure concepts and extract meaning from the free texts. In the clinical domain, creating a semantic schema typically requires input from both a domain expert, such as a clinician, and an NLP expert who will represent clinical concepts created from the clinician's domain expertise into a computable format usable by an NLP system. The goal of this work is to develop a web-based tool, Knowledge Author, that bridges the gap between the clinical domain expert and the NLP system development by facilitating the development of domain content represented in a semantic schema for extracting information from clinical free-text. Knowledge Author is a web-based, recommendation system that supports users in developing domain content necessary for clinical NLP applications. Knowledge Author's schematic model leverages a set of semantic types derived from the Secondary Use Clinical Element Models and the Common Type System to allow the user to quickly create and modify domain-related concepts. Features such as collaborative development and providing domain content suggestions through the mapping of concepts to the Unified Medical Language System Metathesaurus database further supports the domain content creation process. Two proof of concept studies were performed to evaluate the system's performance. The first study evaluated Knowledge Author's flexibility to create a broad range of concepts. A dataset of 115 concepts was created of which 87 (76 %) were able to be created using Knowledge Author. The second study evaluated the effectiveness of Knowledge Author's output in an NLP system by extracting concepts and associated modifiers representing a clinical element, carotid stenosis, from 34 clinical free-text radiology
Visvanathan, Kala; Levit, Laura A; Raghavan, Derek; Hudis, Clifford A; Wong, Sandra; Dueck, Amylou; Lyman, Gary H
ASCO believes that high-quality observational studies can advance evidence-based practice for cancer care and are complementary to randomized controlled trials (RCTs). Observational studies can generate hypotheses by evaluating novel exposures or biomarkers and by revealing patterns of care and relationships that might not otherwise be discovered. Researchers can then test these hypotheses in RCTs. Observational studies can also answer or inform questions that either have not been or cannot be answered by RCTs. In addition, observational studies can be used for postmarketing surveillance of new cancer treatments, particularly in vulnerable populations. The incorporation of observational research as part of clinical decision making is consistent with the position of many leading institutions. ASCO identified five overarching recommendations to enhance the role of observational research in clinical decision making: (1) improve the quality of electronic health data available for research, (2) improve interoperability and the exchange of electronic health information, (3) ensure the use of rigorous observational research methodologies, (4) promote transparent reporting of observational research studies, and (5) protect patient privacy.
Poulin, Marie-France; Deka, Anjan; Mohamedali, Burhan; Schaer, Gary L
The benefits of stem cell therapy for patients with chronic symptomatic systolic heart failure due to ischemic and nonischemic cardiomyopathy (ICM and NICM, respectively) are unclear. We performed a systematic review of major published and ongoing trials of stem cell therapy for systolic heart failure and compared measured clinical outcomes for both types of cardiomyopathy. The majority of the 29 published studies demonstrated clinical benefits of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs). Left ventricular ejection fraction (LVEF) was improved in the majority of trials after therapy. Cell delivery combined with coronary artery bypass grafting was associated with the greatest improvement in LVEF. Left ventricular end-systolic volume (or diameter), New York Heart Association functional classification, quality of life, and exercise capacity were also improved in most studies after cell therapy. Most ICM trials demonstrated a significant improvement in perfusion defects, infarct size, and myocardial viability. Several larger clinical trials that are in progress employ alternative delivery modes, cell types, and longer follow-up periods. Stem cells are a promising therapeutic modality for patients with heart failure due to ICM or NICM. More data are required from larger blinded trials to determine which combination of cell type and delivery mode will yield the most benefit with avoidance of harm in these patient populations.
Colsman, A; Kunzmann, U; Seggewies, C; Mahler, V
The insertion of all patient details in one clinical information system (CIS) provides an enormous potential to rationalize and accelerate the administrative procedures in primary patient care. A successful data management system has to record not only the entire spectrum of the patient's medical data, but also the patient's personal data like name, address, date of birth, as well as names and addresses of other involved physicians. In addition, all aspects of the database gathered from varying sources must be compatible. The program has to be user-friendly enough that many different workers with varying backgrounds can effectively employ it. We investigated the effective saving of time in preparing a patient's discharge report based on conventional dictation using the clinical information system (Soarian) compared to a conventional, isolated word-processing program (Word). Existing potentials and limitations concerning the use of the CIS are presented. The objective analysis of measured processing times demonstrated a reduction for the typist, but no benefit for the physician dictating the discharge report. In the subjective perception of all users, the processing time appeared to have increased due to awkward editing and navigation functions. Improvements are required to increase the acceptance of the program by the users.
Moen, Hans; Ginter, Filip; Marsi, Erwin; Peltonen, Laura-Maria; Salakoski, Tapio; Salanterä, Sanna
Patients' health related information is stored in electronic health records (EHRs) by health service providers. These records include sequential documentation of care episodes in the form of clinical notes. EHRs are used throughout the health care sector by professionals, administrators and patients, primarily for clinical purposes, but also for secondary purposes such as decision support and research. The vast amounts of information in EHR systems complicate information management and increase the risk of information overload. Therefore, clinicians and researchers need new tools to manage the information stored in the EHRs. A common use case is, given a--possibly unfinished--care episode, to retrieve the most similar care episodes among the records. This paper presents several methods for information retrieval, focusing on care episode retrieval, based on textual similarity, where similarity is measured through domain-specific modelling of the distributional semantics of words. Models include variants of random indexing and the semantic neural network model word2vec. Two novel methods are introduced that utilize the ICD-10 codes attached to care episodes to better induce domain-specificity in the semantic model. We report on experimental evaluation of care episode retrieval that circumvents the lack of human judgements regarding episode relevance. Results suggest that several of the methods proposed outperform a state-of-the art search engine (Lucene) on the retrieval task.
Silverman, S L; Wang, A; Cheng, L; Yang, Y; Libanati, C; Geller, M; Grauer, A; Nevitt, M; Revicki, D; Viswanathan, H N
Two comorbidity indices were adapted for use in the FREEDOM trial and significantly correlated with the number of medications and impaired health status at baseline. The indices have applications for the analysis of clinical trial data and would allow for the appropriate adjustment of comorbidities when evaluating clinical trial outcomes. The purpose of this study is to adapt two published comorbidity indices for use with the FREEDOM clinical trial evaluating postmenopausal women with osteoporosis. FREEDOM enrolled women aged 60-90 years with a bone mineral density T-score <-2.5 at the lumbar spine or total hip and ≥-4.0 at both sites. Comorbidity indices were calculated using methods described by Sangha (Arthritis Rheum 49:156-163, 2003) and Wolfe (J Rheumatol 37:305-315, 2010) following modification. The adapted Sangha index included 12 conditions with a summary score of 0-12; the adapted Wolfe index included 7 conditions with a weighted summary score of 0-8. Higher scores indicated greater comorbidity. A panel of clinicians independently reviewed subjects' medical histories using a systematic process based on Medical Dictionary for Regulatory Activities (MedDRA) preferred terms to map specified comorbid conditions. Spearman correlations between the adapted indices and baseline subject characteristics expected to be associated with comorbidities were examined. Of the 7808 subjects in this study, 74 % had ≥1 comorbidities based on the adapted Sangha or Wolfe comorbidity indices. The mean (SD) adapted Sangha and Wolfe comorbidity indices were 1.4 (1.2) and 1.4 (1.3), respectively. Both indices correlated positively with age, body mass index, and the number of medications (r = 0.54 to 0.55) at baseline and inversely correlated with health-related quality of life (r = -0.22 to -0.30) (all P < 0.0001). Further, when either the adapted Sangha or Wolfe index was included as a covariate for assessing mortality over 36 months in the FREEDOM population, the
Selsky, Claire; Luta, George; Noone, Anne-Michelle; Huerta, Elmer E; Mandelblatt, Jeanne S
Internet use is widespread, but little is known about Internet use for cancer information among Latinos, especially those who rely on safety net clinics. The authors investigated access to and intended use of the Internet for cancer information among low income, immigrant Latinos predominately from Central and South America. A cross-sectional study of 1,273 Latinos 21 years and older attending safety net clinics or health fairs was conducted from June 2007 to November 2008. The authors used logistic regression models to evaluate associations of age, acculturation, psychosocial factors and other covariates with Internet access and intended use of the Internet for cancer information among those with access. Of the sample, 44% reported Internet access. Higher information self-efficacy and greater trust in the Internet were independently associated with Internet access (p = .05 and p access, 53.8% reported they intended to seek cancer help online if they needed information. Those with younger age and higher acculturation, education and self-efficacy had higher odds of intended Internet use for cancer information, considering covariates. In addition, those with high (vs. low) perceived risk of cancer (OR = 1.76; 95% CI [1.14, 2.73]; p = .01) and higher levels of trust in online health information (OR = 1.47 per one-point increase; 95% [CI 1.19, 1.82]; p = .0004) were more likely to intend to seek cancer information online. These findings that Internet access is fairly high in the immigrant Latino population and that the Internet is a trusted source of cancer information suggest that the Internet may be a channel for cancer control interventions.
Shea, Steven; Clark, Anthony S.; Clayton, Paul D.
We describe a clinical information system for hospital-based ambulatory care implemented in the context of the institution's IAIMS Phase III effort. Key features of this application are physician data entry to maintain summary clinical profiles that include medication lists, problem lists, and preventive care, and integration with other components of the Clinical Information System at the levels of the database, the user interface, and data sharing. A goal of this application is to provide co...
Mishra, Rashmi; Fiol, Guilherme Del; Kilicoglu, Halil; Jonnalagadda, Siddhartha; Fiszman, Marcelo
Clinicians raise several information needs in the course of care. Most of these needs can be met by online health knowledge resources such as UpToDate. However, finding relevant information in these resources often requires significant time and cognitive effort. Objective: To design and assess algorithms for extracting from UpToDate the sentences that represent the most clinically useful information for patient care decision making. Methods: We developed algorithms based on semantic predications extracted with SemRep, a semantic natural language processing parser. Two algorithms were compared against a gold standard composed of UpToDate sentences rated in terms of clinical usefulness. Results: Clinically useful sentences were strongly correlated with predication frequency (correlation= 0.95). The two algorithms did not differ in terms of top ten precision (53% vs. 49%; p=0.06). Conclusions: Semantic predications may serve as the basis for extracting clinically useful sentences. Future research is needed to improve the algorithms. PMID:24551389
Martindale, S J; Chambers, E; Thompson, A R
To explore and describe the experience of clinical psychology service users in relation to the processes associated with confidentiality and the generation of informed consent in individual therapy. A qualitative interview-based study employing interpretative phenomenological analysis was conducted with service users. User researchers were active collaborators in the study. A focus group of four users was convened to explore issues related to confidentiality and consent, which then informed the development of the semi-structured interview schedule. Twelve users of community mental health clinical psychology services were interviewed by user researchers. A user researcher and a clinical psychologist undertook joint analysis of the data. A second clinical psychologist facilitated reflexivity and wider consideration of validity issues. Four main themes were identified from the data: being referred; the participant's feelings, mental health difficulties, and their impact; relationships with workers and carers; and autonomy. The meaningfulness of processes of discussing confidentiality, and generating informed consent, can be improved by psychologists placing a greater emphasis on choice, control, autonomy, individual preferences, and actively involving the user in dialogue on repeated occasions.
The primary focus of this pilot study was to gain a better understanding of the information needs of emergency-care clinicians. The secondary focus was to compare the traditional current practice of information provision within other emergency departments in Greek hospitals, with the new model of clinical librarianship (CL). Clinical staff in the emergency department deal with a variety of cases, they have no time to visit the library, but need information instantly in their place of work. Clinical decision making in the emergency department setting frequently requires the clinician to obtain additional sources of information and clinical librarians may facilitate this. The present study focused on two professional groups: medical librarians (group A) and clinicians (consultants, senior registrars, registrars, nurses (group B), working in the emergency departments of two Greek hospitals. The study was organized through a questionnaire survey and some in-depth interviews. This study showed that, for 100% of the clinicians in daily practice, the main information needs arise while treating patients, and that information would help in making patient-care decisions. Clinicians made little use of hospital libraries because they are usually under tremendous time pressure. The main outcome of the study was the use of a clinical librarian as an information provider. Clinical librarians supply information to assist decisions, based on this model. This extends the librarian's role in evidence-based medicine, giving much stronger attention to the relevant evidence in clinical practice. Nowadays, health services are facing organizational change. The introduction of new technology, and rapid growth of medical knowledge creates a demand for new ways of providing information. Clinical librarian programmes may deliver patients specific information in a timely manner. The mission of the clinical librarian is to facilitate access to quality information which is necessary for
Kim, Hyeoneui; Bell, Elizabeth; Kim, Jihoon; Sitapati, Amy; Ramsdell, Joe; Farcas, Claudiu; Friedman, Dexter; Feupe, Stephanie Feudjio; Ohno-Machado, Lucila
Implementation of patient preferences for use of electronic health records for research has been traditionally limited to identifiable data. Tiered e-consent for use of de-identified data has traditionally been deemed unnecessary or impractical for implementation in clinical settings. We developed a web-based tiered informed consent tool called informed consent for clinical data and bio-sample use for research (iCONCUR) that honors granular patient preferences for use of electronic health record data in research. We piloted this tool in 4 outpatient clinics of an academic medical center. Of patients offered access to iCONCUR, 394 agreed to participate in this study, among whom 126 patients accessed the website to modify their records according to data category and data recipient. The majority consented to share most of their data and specimens with researchers. Willingness to share was greater among participants from an Human Immunodeficiency Virus (HIV) clinic than those from internal medicine clinics. The number of items declined was higher for for-profit institution recipients. Overall, participants were most willing to share demographics and body measurements and least willing to share family history and financial data. Participants indicated that having granular choices for data sharing was appropriate, and that they liked being informed about who was using their data for what purposes, as well as about outcomes of the research. This study suggests that a tiered electronic informed consent system is a workable solution that respects patient preferences, increases satisfaction, and does not significantly affect participation in research.
Izadi, Morteza; Fazel, Mozhgan; Nasiri-Vanashi, Taha; Saadat, Seyed Hasan; Taheri, Saeed
Informed consent is a critical issue especially in conducting clinical trials that expose human life to medical or surgical interventions. It necessitates a long and complex process through which the participant is presented with all potential favorable and non-favorable consequences upon getting enrolled in the study. The process of taking informed consent is well-understood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to participate or not. This may not be the case in the developing world.The information given to patients before the trial might not be properly developed and presented, an issue that can result in serious threat to the decision-making process. On the other hand, investigators should remember that enrolling people into a trial with no potential benefit for themselves cannot be considered ethical. In the current debate, we aim to address the issue of how respectfully and ethically clinical research trials can be done on human subjects and what we can do to enhance the practice in an ethical context. Development of a system through which we could warrant all rights of study participants in all cases around the world seems far from view. However, if we are in doubt about the ethics of a clinical trial, we can ask ourselves: "what would we do, if we were in the same position our patients are in now?"
Gellert, G A; Hill, V; Bruner, K; Maciaz, G; Saucedo, L; Catzoela, L; Ramirez, R; Jacobs, W J; Nguyen, P; Patel, L; Webster, S L
To identify and describe the most critical strategic and operational contributors to the successful implementation of clinical information technologies, as deployed within a moderate sized system of U.S. community hospitals. CHRISTUS Health is a multi-state system comprised of more than 350 services and 60 hospitals with over 9 000 physicians. The Santa Rosa region of CHRISTUS Health, located in greater San Antonio, Texas is comprised of three adult community hospital facilities and one Children's hospital each with bed capacities of 142-180. Computerized Patient Order Entry (CPOE) was first implemented in 2012 within a complex market environment. The Santa Rosa region has 2 417 credentialed physicians and 263 mid-level allied health professionals. This report focuses on the seven most valuable strategies deployed by the Health Informatics team in a large four hospital CHRISTUS region to achieve strong CPOE adoption and critical success lessons learned. The findings are placed within the context of the literature describing best practices in health information technology implementation. While the elements described involved discrete de novo process generation to support implementation and operations, collectively they represent the creation of a new customer-centric service culture in our Health Informatics team, which has served as a foundation for ensuring strong clinical information technology adoption beyond CPOE. The seven success factors described are not limited in their value to and impact on CPOE adoption, but generalize to - and can advance success in - varied other clinical information technology implementations across diverse hospitals. A number of these factors are supported by reports in the literature of other institutions' successful implementations of CPOE and other clinical information technologies, and while not prescriptive to other settings, may be adapted to yield value elsewhere.
Turisco, Fran; Keogh, Diane; Stubbs, Connie; Glaser, John; Crowley Jr, William F
Little information exists about the incorporation of information technologies (ITs) into clinical research processes within US academic health centers (AHCs). Therefore, we queried a group of 37 leading AHCs regarding their current status and future plans in clinical research IT. The survey specifically inquired about the presence or absence of basic infrastructure and IT support requirements; individual applications needed to support study preparation, study conduct, and its administrative support; and integration of data from basic research, clinical trials, and the clinical information systems increasingly used in health care delivery. Of the 37 AHCs, 78% responded. All strongly agreed that a "state-of-the-art" clinical research IT program would be ideal today and will be essential tomorrow. Nonetheless, no AHC currently has an IT solution that even approached this ideal. No AHC reported having all of the essential management foundations (ie, a coherent vision, an overall strategy, a governance structure, and a dedicated budget) necessary to launch and sustain a truly successful implementation of a cohesive clinical research IT platform. Many had achieved breakthroughs in individual aspects of clinical research IT, for example, adverse event reporting systems or consent form templates. However, overall implementation of IT to support clinical research is uneven and insufficient. These data document a substantial gap in clinical research IT investments in leading US AHCs. Linking the clinical research IT enterprise with its clinical operations in a meaningful fashion remains a crucial strategic goal of AHCs. If they are to continue to serve as the "translational research engines" that our society expects, AHCs must recognize this gap and allocate substantial resource deployment to remedying this situation.
Lau, Francis; Price, Morgan; Keshavjee, Karim
This article proposes a Clinical Adoption Framework for making sense of health information system (HIS) success in Canada. It extends Canada Health Infoway's Benefits Evaluation Framework with contextual factors that influence HIS adoption by clinicians, which include people, organization, implementation, and the macro environment. Our hypothesis is that successful clinical adoption of an HIS requires explicit recognition, strategies and actions that address the factors described in the framework. Validation of this framework by stakeholders and literature has thus far been favourable. Its potential application with selected evaluation approaches in specific settings, the implications and work ahead are discussed.
Herson, J; Crocker, C L; Butts, E; Phong, L T; Haynes, J A
The management information system (FP/MIS) used by the Howard University Center for Family Planning Services, which operates community family planning clinics in Washington, D.C. is described. The system was developed to satisfy program objectives in patient management, program planning and evaluation, resource management, federal reporting systems and clinical, epidemiological and health services research. The data collection forms used in the system and the output from the four data display groups--patient profile, resource management, quality of care and epidemiology-are described along with examples of their use.
Mussavi Rizi, Seyed Ali; Roudsari, Abdul
HL7 CDA, vMR, and openEHR archetypes have been utilized as standard information models for clinical decision support systems. Compared to openEHR archetypes, vMR typically requires less time to develop and extend which makes it a good fit for rapid prototyping and pilot projects, while openEHR archetypes handle the data and semantic specification better. Using CDA for clinical decision support systems is discouraged due to its complexity, steep learning curve, and potential safety issues.
Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H
Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study
Suominen, Hanna; Zhou, Liyuan; Hanlen, Leif; Ferraro, Gabriela
Over a tenth of preventable adverse events in health care are caused by failures in information flow. These failures are tangible in clinical handover; regardless of good verbal handover, from two-thirds to all of this information is lost after 3-5 shifts if notes are taken by hand, or not at all. Speech recognition and information extraction provide a way to fill out a handover form for clinical proofing and sign-off. The objective of the study was to provide a recorded spoken handover, annotated verbatim transcriptions, and evaluations to support research in spoken and written natural language processing for filling out a clinical handover form. This dataset is based on synthetic patient profiles, thereby avoiding ethical and legal restrictions, while maintaining efficacy for research in speech-to-text conversion and information extraction, based on realistic clinical scenarios. We also introduce a Web app to demonstrate the system design and workflow. We experiment with Dragon Medical 11.0 for speech recognition and CRF++ for information extraction. To compute features for information extraction, we also apply CoreNLP, MetaMap, and Ontoserver. Our evaluation uses cross-validation techniques to measure processing correctness. The data provided were a simulation of nursing handover, as recorded using a mobile device, built from simulated patient records and handover scripts, spoken by an Australian registered nurse. Speech recognition recognized 5276 of 7277 words in our 100 test documents correctly. We considered 50 mutually exclusive categories in information extraction and achieved the F1 (ie, the harmonic mean of Precision and Recall) of 0.86 in the category for irrelevant text and the macro-averaged F1 of 0.70 over the remaining 35 nonempty categories of the form in our 101 test documents. The significance of this study hinges on opening our data, together with the related performance benchmarks and some processing software, to the research and development
Mayfield, Elijah; Laws, M Barton; Wilson, Ira B; Penstein Rosé, Carolyn
Coding of clinical communication for fine-grained features such as speech acts has produced a substantial literature. However, annotation by humans is laborious and expensive, limiting application of these methods. We aimed to show that through machine learning, computers could code certain categories of speech acts with sufficient reliability to make useful distinctions among clinical encounters. The data were transcripts of 415 routine outpatient visits of HIV patients which had previously been coded for speech acts using the Generalized Medical Interaction Analysis System (GMIAS); 50 had also been coded for larger scale features using the Comprehensive Analysis of the Structure of Encounters System (CASES). We aggregated selected speech acts into information-giving and requesting, then trained the machine to automatically annotate using logistic regression classification. We evaluated reliability by per-speech act accuracy. We used multiple regression to predict patient reports of communication quality from post-visit surveys using the patient and provider information-giving to information-requesting ratio (briefly, information-giving ratio) and patient gender. Automated coding produces moderate reliability with human coding (accuracy 71.2%, κ=0.57), with high correlation between machine and human prediction of the information-giving ratio (r=0.96). The regression significantly predicted four of five patient-reported measures of communication quality (r=0.263-0.344). The information-giving ratio is a useful and intuitive measure for predicting patient perception of provider-patient communication quality. These predictions can be made with automated annotation, which is a practical option for studying large collections of clinical encounters with objectivity, consistency, and low cost, providing greater opportunity for training and reflection for care providers.
Wilcox, R A; La Tella, R R
Personal digital assistants can provide a portable, integrated platform for point-of-care clinical reference, patient management and data communication. Clinical reference programs allow the user to access information from the Internet and guidelines. Patient management programs allow doctors to access and store clinical information. Wireless technologies have potential for rapid exchange of clinical laboratory results and efficient "electronic patient handovers". Thus, these devices provide the potential for true continuity of care across the healthcare system.
Kashihara, Hidenori; Nakayama, Takeo; Hatta, Taichi; Takahashi, Naomi; Fujita, Misao
Although the safety and effectiveness of stem cell therapies are yet to be proven, recent studies show that such therapies are being advertised with some questionable marketing techniques to effect positive portrayal of the therapies on the webpages of private-practice clinics to sell their therapies worldwide. In such context, those clinics communicate directly with consumers (patients and their family members) via the clinics' websites. Meanwhile, the Health Science Council at the Ministry of Health, Labour, and Welfare (MHLW) in Japan has pointed out noncompliance of some local clinics with the provisions concerning medical advertising in the Medical Care Act in the past. However, locally little is known about the current status of those clinics including the quality of their webpage information disseminated. To evaluate the quality of website information of private-practice clinics offering cell therapies in Japan. Twenty-four websites with 77 treatments from the Google search were identified for evaluation. The following three exploratory analyses were performed: first in order to ascertain web-based portrayal of private-practice clinics offering cell therapies, a descriptive analysis was conducted using a coding frame; second we evaluated the quality of the target website information from the viewpoint of the level of consideration taken for patients and their family members, using 10 quality criteria ("the Minimum Standard") from the e-Health Code of Ethics 2.0; third we counted and coded expressions that matched set categories for "name-dropping" and "personalized medicine" in the information posted on these websites. Analysis on the treatments (N=77) revealed 126 indications (multiple response): the top three indications were "cancer," "skin-rejuvenation/antiaging/anti-skin aging," and "breast augmentation/buttock augmentation." As for the portrayal of treatment risks and benefits, 78% (60/77) of treatments were mentioned with "benefits," whereas 77% (59
Schiavoni, Katherine H; Lehmann, Lisa Soleymani; Guan, Wendy; Rosenthal, Meredith; Sequist, Thomas D; Chien, Alyna T
Little is known about how primary care physicians (PCPs) in routine outpatient practice use paid price information (i.e., the amount that insurers finally pay providers) in daily clinical practice. To describe the experiences of PCPs who have had paid price information on tests and procedures for at least 1 year. Cross-sectional study using semi-structured interviews and the constant comparative method of qualitative analysis. Forty-six PCPs within an accountable care organization. Via the ordering screen of their electronic health record, PCPs were presented with the median paid price for commonly ordered tests and procedures (e.g., blood tests, x-rays, CTs, MRIs). We asked PCPs for (a) their "gut reaction" to having paid price information, (b) the situations in which they used price information in clinical decision-making separate from or jointly with patients, (c) their thoughts on who bore the chief responsibility for discussing price information with patients, and (d) suggestions for improving physician-targeted price information interventions. Among "gut reactions" that ranged from positive to negative, all PCPs were more interested in having patient-specific price information than paid prices from the practice perspective. PCPs described that when patients' out-of-pocket spending concerns were revealed, price information helped them engage patients in conversations about how to alter treatment plans to make them more affordable. PCPs stated that having price information only slightly altered their test-ordering patterns and that they avoided mentioning prices when advising patients against unnecessary testing. Most PCPs asserted that physicians bear the chief responsibility for discussing prices with patients because of their clinical knowledge and relationships with patients. They wished for help from patients, practices, health plans, and society in order to support price transparency in healthcare. Physician-targeted price transparency efforts may
Scherer, Susanne; Hansen, Steen Holger; Lynnerup, Niels
INTRODUCTION: From the clinical forensic examination reports made at the Department of Forensic Medicine, the University of Copenhagen, in 2007 concerning rape, attempted rape and sexual assault (RAS), information about the assault, including both violence and the perpetrator's line of sexual...... by slight, blunt force. Information on line of sexual action was present in 148 cases. A total of 123 victims reported penetration: 94% vaginal, 16% anal and 20% oral. Three were exposed to anal penetration only. Eleven perpetrators used a condom. 50% of the cases with vaginal and/or anal penetration had...
Full Text Available The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. First, the juridical basis of informed consent in South African law is outlined; and second, the requirements for lawful consent developed in South African common law and case law are presented. Finally, the article deliberates upon the requirements for the participation of mentally ill persons in research as laid down by the Mental Health Care Act and its regulations, the National Health Act and its (draft regulations, and the South African Constitution.
Clinical trials in a number of countries are now underway to evaluate experimental, non-human blood substitute. One scenario calls for the blood substitute to be available on board emergency vehicles. This allows first responders the opportunity to provide transfusion support at an accident site and on the way to the hospital. However, many of the patients who would most benefit from the use of this material may be unconscious and unable to comprehend or sign an informed consent. One possible solution would be to eliminate the need for informed consent.
Since researchers first became aware of the anticaries action of fluoride, they have been investigating the effect of this preventive agent in inhibiting or arresting caries development. Many forms of systemic or topical fluoride have been studied and tested for clinical application. Water, salt, milk fluoridation and the use of fluoride supplements were introduced for systemic fluoridation mainly using sodium fluoride. Solutions, gels, toothpastes and rinses of sodium fluoride, stannous fluoride, amine fluorides, acidulated phosphate fluoride and monofluorophosphate were used for topical fluoridation. More recently nonaqueous fluoride varnishes in an alcoholic solution of natural resins and difluorosilane agents in a polyurethane matrix were introduced. Although all of these fluoridation methods have a caries-preventive action, these benefits and the ease of application is variable. As fluoride is a key component of oral health promotion a coordinated approach on a community and individual basis seems to be needed to maximize the cost-benefit ratio of prevention. Copyright 2001 S. Karger AG, Basel.
Silva, Cristina; Fresco, Paula; Monteiro, Joaquim; Rama, Ana Cristina Ribeiro
Evidence-Based Practice requires health care decisions to be based on the best available evidence. The model "Information Mastery" proposes that clinicians should use sources of information that have previously evaluated relevance and validity, provided at the point of care. Drug databases (DB) allow easy and fast access to information and have the benefit of more frequent content updates. Relevant information, in the context of drug therapy, is that which supports safe and effective use of medicines. Accordingly, the European Guideline on the Summary of Product Characteristics (EG-SmPC) was used as a standard to evaluate the inclusion of relevant information contents in DB. To develop and test a method to evaluate relevancy of DB contents, by assessing the inclusion of information items deemed relevant for effective and safe drug use. Hierarchical organisation and selection of the principles defined in the EGSmPC; definition of criteria to assess inclusion of selected information items; creation of a categorisation and quantification system that allows score calculation; calculation of relative differences (RD) of scores for comparison with an "ideal" database, defined as the one that achieves the best quantification possible for each of the information items; pilot test on a sample of 9 drug databases, using 10 drugs frequently associated in literature with morbidity-mortality and also being widely consumed in Portugal. Main outcome measure Calculate individual and global scores for clinically relevant information items of drug monographs in databases, using the categorisation and quantification system created. A--Method development: selection of sections, subsections, relevant information items and corresponding requisites; system to categorise and quantify their inclusion; score and RD calculation procedure. B--Pilot test: calculated scores for the 9 databases; globally, all databases evaluated significantly differed from the "ideal" database; some DB performed
Cervesato, E; Antonini-Canterin, F; Nicolosi, G L
In the last few years, remarkable improvements have been made in computerized database systems used in cardiology. However, they will not easily lead to further relevant improvements unless the weaknesses and the gaps deriving from the obligation of forming and storing case sheets, according to law, are faced and resolved in an original way. This article covers the topic of the digital signature and how it could form the basis for a new powerful impulse to the process of informatization of cardiology records. The proposal of elaborating a totally computerized case sheet involves the need of rationalizing the flow of clinical information and of implementing a management system integrated with the hospital information system. The elimination of paper support will probably lead to an advantageous cycle that will involve the entire hospital, both clinically as well as administratively.
Kim, Gungu; Kim, Gibbeum; Na, Wondo; Han, Woojae
This brief communication introduced a systematic way to find a professional audiology clinic developed for patients and professionals by the American Academy of Audiology, American Speech-Language-Hearing Association, and Healthy Hearing. Patients can access each organization's website to find professionals and/or clinics based on criteria such as location, hours, special areas, types of service, reviews and rating by previous patients, and kinds of insurance accepted. Such a system may protect the patients from information overload, guarantee accurate information, and help them find themselves professional audiologists who can assist them. We expect professional organizations to adopt this system as soon as possible and link hearing-impaired patients with professional audiologists in Korea.
Full Text Available Abstract Background Screening of primary care patients at risk for left ventricular systolic dysfunction by a simple blood-test might reduce referral rates for echocardiography. Whether or not natriuretic peptide testing is a useful and cost-effective diagnostic instrument in primary care settings, however, is still a matter of debate. Methods N-terminal pro-brain natriuretic peptide (NT-proBNP levels, clinical information, and echocardiographic data of left ventricular systolic function were collected in 542 family practice patients with at least one cardiovascular risk factor. We determined the diagnostic power of the NT-proBNP assessment in ruling out left ventricular systolic dysfunction and compared it to a risk score derived from a logistic regression model of easily acquired clinical information. Results 23 of 542 patients showed left ventricular systolic dysfunction. Both NT-proBNP and the clinical risk score consisting of dyspnea at exertion and ankle swelling, coronary artery disease and diuretic treatment showed excellent diagnostic power for ruling out left ventricular systolic dysfunction. AUC of NT-proBNP was 0.83 (95% CI, 0.75 to 0.92 with a sensitivity of 0.91 (95% CI, 0.71 to 0.98 and a specificity of 0.46 (95% CI, 0.41 to 0.50. AUC of the clinical risk score was 0.85 (95% CI, 0.79 to 0.91 with a sensitivity of 0.91 (95% CI, 0.71 to 0.98 and a specificity of 0.64 (95% CI, 0.59 to 0.67. 148 misclassifications using NT-proBNP and 55 using the clinical risk score revealed a significant difference (McNemar test; p Conclusion The evaluation of clinical information is at least as effective as NT-proBNP testing in ruling out left ventricular systolic dysfunction in family practice patients at risk. If these results are confirmed in larger cohorts and in different samples, family physicians should be encouraged to rely on the diagnostic power of the clinical information from their patients.
Background Alcohol misuse remains a major risk factor for contracting sexually transmitted diseases (STDs) not typically addressed in STD clinic settings. Information and communication technology (ICT) can offer new avenues to deliver evidence-based screening and treatment for problematic drinking, however, few data exists regarding the utilization of ICT among STD clinic attendees with coexisting drinking problems. The objectives of this study are to identify STD clinics attendees with hazardous drinking, to examine socio-demographic factors associated with ICT use, and to explore individuals’ interests in engaging in ICT-based health interventions. Methods Cross-sectional questionnaires examining alcohol consumption and ICT use were administered to 396 persons attending two non-urban STD clinics. Descriptive statistics for ICT use were calculated for both hazardous drinkers and the entire sample. Multivariable logistic regression models among hazardous drinkers identified factors significantly associated with use of each kind of ICT. Results The mean age of the 396 participants was 25 years, 66% were females and 60% were African-Americans. One third of the sample met the criteria of hazardous drinking. ICT use in hazardous drinkers included 94% reporting having internet access at least monthly, 82% reporting having an email account, 85% reporting currently owning a cell phone, and 91% reporting use of any cell phone application. More than two thirds (73%) of hazardous drinkers were willing to play health-related video games during clinic waiting time, slightly higher than the entire sample (69%). Multivariable analyses indicated that younger age were significantly related to monthly internet use, and multifunction cell phone use, while being males and younger age were significantly associated with monthly video game playing. Conclusions Our study demonstrates commonality of ICT use among STD clinic attendees with hazardous drinking, indicating the viability of
Hu, Xingdi; Dodd, Virginia J; Oliverio, James C; Cook, Robert L
Alcohol misuse remains a major risk factor for contracting sexually transmitted diseases (STDs) not typically addressed in STD clinic settings. Information and communication technology (ICT) can offer new avenues to deliver evidence-based screening and treatment for problematic drinking, however, few data exists regarding the utilization of ICT among STD clinic attendees with coexisting drinking problems. The objectives of this study are to identify STD clinics attendees with hazardous drinking, to examine socio-demographic factors associated with ICT use, and to explore individuals' interests in engaging in ICT-based health interventions. Cross-sectional questionnaires examining alcohol consumption and ICT use were administered to 396 persons attending two non-urban STD clinics. Descriptive statistics for ICT use were calculated for both hazardous drinkers and the entire sample. Multivariable logistic regression models among hazardous drinkers identified factors significantly associated with use of each kind of ICT. The mean age of the 396 participants was 25 years, 66% were females and 60% were African-Americans. One third of the sample met the criteria of hazardous drinking. ICT use in hazardous drinkers included 94% reporting having internet access at least monthly, 82% reporting having an email account, 85% reporting currently owning a cell phone, and 91% reporting use of any cell phone application. More than two thirds (73%) of hazardous drinkers were willing to play health-related video games during clinic waiting time, slightly higher than the entire sample (69%). Multivariable analyses indicated that younger age were significantly related to monthly internet use, and multifunction cell phone use, while being males and younger age were significantly associated with monthly video game playing. Our study demonstrates commonality of ICT use among STD clinic attendees with hazardous drinking, indicating the viability of using ICT to assist screening and
Bijttebier, Patricia; Vasey, Michael W; Braet, Caroline
Provides an introduction to the special section on information-processing (I-P) factors in child and adolescent psychopathology. First, we describe the I-P paradigm and summarize its central tenets, presenting examples of past research that illustrate the heuristic value of the paradigm. Next, we discuss the potential benefits of the I-P paradigm for the field of clinical child and adolescent psychology. Finally, we present an overview of the articles in the special section.
Nguyen, Dung H M; Wang, Yefeng; Li, Min
Objective Information extraction and classification of clinical data are current challenges in natural language processing. This paper presents a cascaded method to deal with three different extractions and classifications in clinical data: concept annotation, assertion classification and relation classification. Materials and Methods A pipeline system was developed for clinical natural language processing that includes a proofreading process, with gold-standard reflexive validation and correction. The information extraction system is a combination of a machine learning approach and a rule-based approach. The outputs of this system are used for evaluation in all three tiers of the fourth i2b2/VA shared-task and workshop challenge. Results Overall concept classification attained an F-score of 83.3% against a baseline of 77.0%, the optimal F-score for assertions about the concepts was 92.4% and relation classifier attained 72.6% for relationships between clinical concepts against a baseline of 71.0%. Micro-average results for the challenge test set were 81.79%, 91.90% and 70.18%, respectively. Discussion The challenge in the multi-task test requires a distribution of time and work load for each individual task so that the overall performance evaluation on all three tasks would be more informative rather than treating each task assessment as independent. The simplicity of the model developed in this work should be contrasted with the very large feature space of other participants in the challenge who only achieved slightly better performance. There is a need to charge a penalty against the complexity of a model as defined in message minimalisation theory when comparing results. Conclusion A complete pipeline system for constructing language processing models that can be used to process multiple practical detection tasks of language structures of clinical records is presented. PMID:21737844
Patrick, Jon D; Nguyen, Dung H M; Wang, Yefeng; Li, Min
Information extraction and classification of clinical data are current challenges in natural language processing. This paper presents a cascaded method to deal with three different extractions and classifications in clinical data: concept annotation, assertion classification and relation classification. A pipeline system was developed for clinical natural language processing that includes a proofreading process, with gold-standard reflexive validation and correction. The information extraction system is a combination of a machine learning approach and a rule-based approach. The outputs of this system are used for evaluation in all three tiers of the fourth i2b2/VA shared-task and workshop challenge. Overall concept classification attained an F-score of 83.3% against a baseline of 77.0%, the optimal F-score for assertions about the concepts was 92.4% and relation classifier attained 72.6% for relationships between clinical concepts against a baseline of 71.0%. Micro-average results for the challenge test set were 81.79%, 91.90% and 70.18%, respectively. The challenge in the multi-task test requires a distribution of time and work load for each individual task so that the overall performance evaluation on all three tasks would be more informative rather than treating each task assessment as independent. The simplicity of the model developed in this work should be contrasted with the very large feature space of other participants in the challenge who only achieved slightly better performance. There is a need to charge a penalty against the complexity of a model as defined in message minimalisation theory when comparing results. A complete pipeline system for constructing language processing models that can be used to process multiple practical detection tasks of language structures of clinical records is presented.
Phua, J; See, K C; Khalizah, H J; Low, S P; Lim, T K
Clinical questions often arise at daily hospital bedside rounds. Yet, little information exists on how the search for answers may be facilitated. The aim of this prospective study was, therefore, to evaluate the overall utility, including the feasibility and usefulness of incorporating searches of UpToDate, a popular online information resource, into rounds. Doctors searched UpToDate for any unresolved clinical questions during rounds for patients in general medicine and respiratory wards, and in the medical intensive care unit of a tertiary teaching hospital. The nature of the questions and the results of the searches were recorded. Searches were deemed feasible if they were completed during the rounds and useful if they provided a satisfactory answer. A total of 157 UpToDate searches were performed during the study period. Questions were raised by all ranks of clinicians from junior doctors to consultants. The searches were feasible and performed immediately during rounds 44% of the time. Each search took a median of three minutes (first quartile: two minutes, third quartile: five minutes). UpToDate provided a useful and satisfactory answer 75% of the time, a partial answer 17% of the time and no answer 9% of the time. It led to a change in investigations, diagnosis or management 37% of the time, confirmed what was originally known or planned 38% of the time and had no effect 25% of the time. Incorporating UpToDate searches into daily bedside rounds was feasible and useful in clinical decision-making.
Grimes, Susan M; Ji, Hanlee P
Large clinical genomics studies using next generation DNA sequencing require the ability to select and track samples from a large population of patients through many experimental steps. With the number of clinical genome sequencing studies increasing, it is critical to maintain adequate laboratory information management systems to manage the thousands of patient samples that are subject to this type of genetic analysis. To meet the needs of clinical population studies using genome sequencing, we developed a web-based laboratory information management system (LIMS) with a flexible configuration that is adaptable to continuously evolving experimental protocols of next generation DNA sequencing technologies. Our system is referred to as MendeLIMS, is easily implemented with open source tools and is also highly configurable and extensible. MendeLIMS has been invaluable in the management of our clinical genome sequencing studies. We maintain a publicly available demonstration version of the application for evaluation purposes at http://mendelims.stanford.edu. MendeLIMS is programmed in Ruby on Rails (RoR) and accesses data stored in SQL-compliant relational databases. Software is freely available for non-commercial use at http://dna-discovery.stanford.edu/software/mendelims/.
Cho, Jae-Hyoung; Kim, Hun-Sung; Han, Jae-Hoon; Lee, Jin-Hee; Oh, Jeong-Ah; Choi, Yoon-Hee
New diabetes management systems based on interactive communication have been introduced recently, accompanying rapid advances in information technology; these systems are referred to as "ubiquitous diabetes management systems." In such ubiquitous systems, patients and medical teams can communicate via Internet or telecommunications, with patients uploading their glucose data and personal information, and medical teams sending optimal feedback. Clinical evidence from both long-term and short-term trials has been reported by some researchers. Such systems appear to be effective not only in reducing the levels of HbA1c but also in stabilizing glucose control. However, most notably, evidence for the cost-effectiveness of such a system should be demonstrated before it can be propagated out to the general population in actual clinical practice. To establish a cost-effective model, various types of clinical decision supporting software designed to reduce the labor time of physicians must first be developed. A number of sensors and devices for monitoring patients' data are expected to be available in the near future; thus, methods for automatic interconnections between devices and web charts were also developed. Further investigations to demonstrate the clinical outcomes of such a system should be conducted, hopefully leading to a new paradigm of diabetes management. PMID:21076573
Dongquan Chen; Chen, Wei-Bang; Soong, Mayhue; Soong, Seng-Jaw; Orthner, Helmuth F
Organizations that have limited resources need to conduct clinical studies in a cost-effective, but secure way. Clinical data residing in various individual databases need to be easily accessed and secured. Although widely available, digital certification, encryption, and secure web server, have not been implemented as widely, partly due to a lack of understanding of needs and concerns over issues such as cost and difficulty in implementation. The objective of this study was to test the possibility of centralizing various databases and to demonstrate ways of offering an alternative to a large-scale comprehensive and costly commercial product, especially for simple phase I and II trials, with reasonable convenience and security. We report a working procedure to transform and develop a standalone Access database into a secure Web-based secure information system. For data collection and reporting purposes, we centralized several individual databases; developed, and tested a web-based secure server using self-issued digital certificates. The system lacks audit trails. The cost of development and maintenance may hinder its wide application. The clinical trial databases scattered in various departments of an institution could be centralized into a web-enabled secure information system. The limitations such as the lack of a calendar and audit trail can be partially addressed with additional programming. The centralized Web system may provide an alternative to a comprehensive clinical trial management system.
Leveille, Suzanne G; Mejilla, Roanne; Ngo, Long; Fossa, Alan; Elmore, Joann G; Darer, Jonathan; Ralston, James D; Delbanco, Tom; Walker, Jan
As health care costs alarm the nation and the debate increases about the impact of health information technologies, patients are reviewing their medical records increasingly through secure Internet portals. Important questions remain about the impact of portal use on office visits. To evaluate whether use of patient Internet portals to access records is associated with increased primary care utilization. A prospective cohort study. Primary care patients registered on patient Internet portals, within an integrated health system serving rural Pennsylvania and an academic medical center in Boston. Frequency of "clinical portal use" (days/2 mo intervals over 2 y) included secure messaging about clinical issues and viewing laboratory and radiology findings. In year 2, a subset of patients also gained access to their primary care doctor's visit notes. The main outcome was number of primary care office visits. In the first 2 months of the 2-year period, 14% of 44,951 primary care patients engaged in clinical portal use 2 or more days per month, 31% did so 1 day per month, and the remainder had no clinical portal use. Overall, adjusted for age, sex, and chronic conditions, clinical portal use was not associated with subsequent office visits. Fewer than 0.1% of patients engaged in high levels of clinical portal use (31 or more login days in 2 mo) that were associated with 1 or more additional visits in the subsequent 2 months (months 3 and 4). However, the reverse was true: office visits led to subsequent clinical portal use. Similar trends were observed among patients with or without access to visit notes. Patients turn to their portals following visits, but clinical portal use does not contribute to an increase in primary care visits.
Satish Chandrasekhar Nair
Full Text Available Background: The rapid expansion of trials in emerging regions has raised valid concerns about research subject protection, particularly related to informed consent. The purpose of this study is to assess informed consent form (ICF compliance with Good Clinical Practice (GCP guidelines and the readability easeof the ICFs in Abu Dhabi, a potential destination for clinical trials in the UAE. Materials and Methods: A multicenter retrospective cross-sectional analysis of 140 ICFs from industry sponsored and non-sponsored studies was conducted by comparing against a local standard ICF. Flesch-Kincaid Reading Scale was used to assess the readability ease of the forms. Results: Non-sponsored studies had signifi cantly lower overall GCP compliance of 55.8% when compared to 79.5% for industry sponsored studies. Only 33% of sponsored and 16% of non-sponsored studies included basic information on the participants′ rights and responsibilities. Flesch-Kincaid Reading ease score for the informed consent forms from industry sponsored studies was signifi cantly higher 48.9 ± 4.8 as compared to 38.5 ± 8.0 for non-sponsored studies, though both were more complex than recommended. Reading Grade Level score was also higher than expected, but scores for the ICFs from the industry sponsored studies were 9.7 ± 0.7, signifi cantly lower as compared to 12.2 ± 1.3 for non-sponsored studies. Conclusion: In spite of the undisputed benefits of conducting research in emerging markets readability, comprehension issues and the lack of basic essential information call for improvements in the ICFs to protect the rights of future research subjects enrolled in clinical trials in the UAE.
Brown, R F; Butow, P N; Butt, D G; Moore, A R; Tattersall, M H N
Randomised clinical trials have come to be regarded as the gold standard in treatment evaluation. However, many doctors see the discussion of a clinical trial as an intrusion into the doctor-patient relationship and find these discussions difficult to initiate. Detailed informed consent is now a requirement of patient participation in trials; however, it is known that patients commonly fail to understand and recall the information conveyed. These difficulties for doctors and patients raise questions about the ethical integrity of the informed consent process. In this study, we have developed a set of communication strategies underpinned by ethical, linguistic and psychological theory, designed to assist doctors in this difficult task. Initially, audiotape transcripts of 26 consultations in which 10 medical oncologists invited patients to participate in clinical trials were analysed by expert ethicists, linguists, oncologists and psychologists, using rigorous qualitative methodology. A subset of seven of these was subjected to detailed linguistic analysis. A strategies document was developed to address themes which emerged from these analyses. This document was presented to relevant expert stakeholders. Their feedback was incorporated into the final document. Four themes emerged from the analysis; (a) shared decision-making, (b) the sequence of moves in the consultation, (c) the type and clarity of the information provided and (d) disclosure of controversial information and coercion. Detailed strategies were developed to assist doctors to communicate in these areas. We have developed a set of ethical strategies which may assist health professionals in this difficult area. A training package based on these strategies is currently being evaluated in a multi-centre randomised controlled trial.
Ingebrigtsen, Tor; Georgiou, Andrew; Clay-Williams, Robyn; Magrabi, Farah; Hordern, Antonia; Prgomet, Mirela; Li, Julie; Westbrook, Johanna; Braithwaite, Jeffrey
To conduct a systematic review to examine evidence of associations between clinical leadership and successful information technology (IT) adoption in healthcare organisations. We searched Medline, Embase, Cinahl, and Business Source Premier for articles published between January 2000 to May 2013 with keywords and subject terms related to: (1) the setting--healthcare provider organisations; (2) the technology--health information technology; (3) the process--adoption; and (4) the intervention--leadership. We identified 3121 unique citations, of which 32 met our criteria and were included in the review. Data extracted from the included studies were assessed in light of two frameworks: Bassellier et al.'s IT competence framework; and Avgar et al.'s health IT adoption framework. The results demonstrate important associations between the attributes of clinical leaders and IT adoption. Clinical leaders who have technical informatics skills and prior experience with IT project management are likely to develop a vision that comprises a long-term commitment to the use of IT. Leaders who possess such a vision believe in the value of IT, are motivated to adopt it, and can maintain confidence and stability through the adversities that IT adoptions often entail. This leads to proactive leadership behaviours and partnerships with IT professionals that are associated with successful organisational and clinical outcomes. This review provides evidence that clinical leaders can positively contribute to successful IT adoption in healthcare organisations. Clinical leaders who aim for improvements in the processes and quality of care should cultivate the necessary IT competencies, establish mutual partnerships with IT professionals, and execute proactive IT behaviours to achieve successful IT adoption. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Silva-Rodríguez, Jesus [Instituto de Investigaciones Sanitarias (IDIS), Santiago de Compostela (Spain); Tsoumpas, Charalampos [University of Leeds, Leeds (United Kingdom); Aguiar, Pablo; Cortes, Julia [Nuclear Medicine Department, University Hospital (CHUS), Santiago de Compostela (Spain); Urdaneta, Jesus Lopez [Instituto de Investigaciones Sanitarias (IDIS), Santiago de Compostela (Spain)
An important counterpart of clinical Positron Emission Tomography (PET) for early diagnosis of neurological diseases is its low resolution. This is particularly important when evaluating diseases related to small hypometabolisms such as epilepsy. The last years, new hybrid systems combining PET with Magnetic Resonance (MR) has been increasingly used for several different clinical applications. One of the advantages of MR is the production of high spatial resolution images and a potential application of PET-MR imaging is the improvement of PET resolution using MR information. A potential advantage of resolution recovery of PET images is the enhancement of contrast delivering at the same time better detectability of small lesions or hypometabolic areas and more accurate quantification over these areas. Recently, Shidahara et al (2009) proposed a new method using wavelet transforms in order to produce PET images with higher resolution. We optimised Shidahara’s method (SFS-RR) to take into account possible shortcomings on the particular clinical datasets, and applied it to a group of patients diagnosed with refractory epilepsy. FDG-PET and MRI images were acquired sequentially and then co-registered using software tools. A complete evaluation of the PET/MR images was performed before and after the correction, including different parameters related with PET quantification, such as atlas-based metabolism asymmetry coefficients and Statistical Parametric Mapping results comparing to a database of 87 healthy subjects. Furthermore, an experienced physician analyzed the results of non-corrected and corrected images in order to evaluate improvements of detectability on a visual inspection. Clinical outcome was used as a gold standard. SFS-RR demonstrated to have a positive impact on clinical diagnosis of small hypometabolisms. New lesions were detected providing additional clinically relevant information on the visual inspection. SPM sensitivity for the detection of small
Clark, Anthony S.; Shea, Steven
This paper describes the development of a Controlled Vocabulary for medication and problem/diagnostic lists in an ambulatory patient care information system within the institution's overall IAIMS framework. This Controlled Vocabulary is used in a spell-checking filter for uploading existing free text data and for on-line entry of new data by physicians. The Controlled Vocabulary consists of a reference file, keyed by code, and an inverted word index file to access it. It is currently loaded with an in-house produced set of medication codes and SNOMED Level 1 Disease codes supplemented by additional user entries.
Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P
New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.
McMurry, Andrew J; Gilbert, Clint A; Reis, Ben Y; Chueh, Henry C; Kohane, Isaac S; Mandl, Kenneth D
This study sought to define a scalable architecture to support the National Health Information Network (NHIN). This architecture must concurrently support a wide range of public health, research, and clinical care activities. The architecture fulfils five desiderata: (1) adopt a distributed approach to data storage to protect privacy, (2) enable strong institutional autonomy to engender participation, (3) provide oversight and transparency to ensure patient trust, (4) allow variable levels of access according to investigator needs and institutional policies, (5) define a self-scaling architecture that encourages voluntary regional collaborations that coalesce to form a nationwide network. Our model has been validated by a large-scale, multi-institution study involving seven medical centers for cancer research. It is the basis of one of four open architectures developed under funding from the Office of the National Coordinator of Health Information Technology, fulfilling the biosurveillance use case defined by the American Health Information Community. The model supports broad applicability for regional and national clinical information exchanges. This model shows the feasibility of an architecture wherein the requirements of care providers, investigators, and public health authorities are served by a distributed model that grants autonomy, protects privacy, and promotes participation.
Willan, Andrew; Kowgier, Matthew
Traditional sample size calculations for randomized clinical trials depend on somewhat arbitrarily chosen factors, such as Type I and II errors. An effectiveness trial (otherwise known as a pragmatic trial or management trial) is essentially an effort to inform decision-making, i.e., should treatment be adopted over standard? Taking a societal perspective and using Bayesian decision theory, Willan and Pinto (Stat. Med. 2005; 24:1791-1806 and Stat. Med. 2006; 25:720) show how to determine the sample size that maximizes the expected net gain, i.e., the difference between the cost of doing the trial and the value of the information gained from the results. These methods are extended to include multi-stage adaptive designs, with a solution given for a two-stage design. The methods are applied to two examples. As demonstrated by the two examples, substantial increases in the expected net gain (ENG) can be realized by using multi-stage adaptive designs based on expected value of information methods. In addition, the expected sample size and total cost may be reduced. Exact solutions have been provided for the two-stage design. Solutions for higher-order designs may prove to be prohibitively complex and approximate solutions may be required. The use of multi-stage adaptive designs for randomized clinical trials based on expected value of sample information methods leads to substantial gains in the ENG and reductions in the expected sample size and total cost.
Zhang, Yuanpeng; Wang, Li; Qian, Danmin; Geng, Xingyun; Yao, Dengfu; Dong, Jiancheng
To extract expert clinic information from the Deep Web, there are two challenges to face. The first one is to make a judgment on forms. A novel method based on a domain model, which is a tree structure constructed by the attributes of query interfaces is proposed. With this model, query interfaces can be classified to a domain and filled in with domain keywords. Another challenge is to extract information from response Web pages indexed by query interfaces. To filter the noisy information on a Web page, a block importance model is proposed, both content and spatial features are taken into account in this model. The experimental results indicate that the domain model yields a precision 4.89% higher than that of the rule-based method, whereas the block importance model yields an F1 measure 10.5% higher than that of the XPath method. Copyright © 2015 Elsevier Ltd. All rights reserved.
Rosenkrantz, Andrew B; Doshi, Ankur M
To assess information regarding radiology practices on public transparency Web sites. Eight Web sites comparing radiology centers' price and quality were identified. Web site content was assessed. Six of eight Web sites reported examination prices. Other reported information included hours of operation (4/8), patient satisfaction (2/8), American College of Radiology (ACR) accreditation (3/8), on-site radiologists (2/8), as well as parking, accessibility, waiting area amenities, same/next-day reports, mammography follow-up rates, examination appropriateness, radiation dose, fellowship-trained radiologists, and advanced technologies (1/8 each). Transparency Web sites had a preponderance of price (and to a lesser extent service quality) information, risking fostering price-based competition at the expense of clinical quality. Copyright © 2016 Elsevier Inc. All rights reserved.
Ubertini, Pietro; Sidoli, L.; Sguera, V.; Bazzano, A.
Supergiant Fast X-ray Transients (SFXTs) are one of the most interesting (and unexpected) results of the INTEGRAL mission. They are a new class of HMXBs displaying short hard X-ray outbursts (duration less tha a day) characterized by fast flares (few hours timescale) and large dinamic range (10E3-10E4). The physical mechanism driving their peculiar behaviour is still unclear and highly debated: some models involve the structure of the supergiant companion donor wind (likely clumpy, in a spherical or non spherical geometry) and the orbital properties (wide separation with eccentric or circular orbit), while others involve the properties of the neutron star compact object and invoke very low magnetic field values (B 1E14 G, magnetars). The picture is still highly unclear from the observational point of view as well: no cyclotron lines have been detected in the spectra, thus the strength of the neutron star magnetic field is unknown. Orbital periods have been measured in only 4 systems, spanning from 3.3 days to 165 days. Even the duty cycle seems to be quite different from source to source. The Energetic X-ray Imaging Survey Telescope (EXIST), with its hard X-ray all-sky survey and large improved limiting sensitivity, will allow us to get a clearer picture of SFXTs. A complete census of their number is essential to enlarge the sample. A long term and continuous as possible X-ray monitoring is crucial to -(1) obtain the duty cycle, -(2 )investigate their unknown orbital properties (separation, orbital period, eccentricity),- (3) to completely cover the whole outburst activity, (4)-to search for cyclotron lines in the high energy spectra. EXIST observations will provide crucial informations to test the different models and shed light on the peculiar behaviour of SFXTs.
Hess, Kenneth R; Wei, Caimiao; Qi, Yuan; Iwamoto, Takayuki; Symmans, W Fraser; Pusztai, Lajos
Our goal was to examine how various aspects of a gene signature influence the success of developing multi-gene prediction models. We inserted gene signatures into three real data sets by altering the expression level of existing probe sets. We varied the number of probe sets perturbed (signature size), the fold increase of mean probe set expression in perturbed compared to unperturbed data (signature strength) and the number of samples perturbed. Prediction models were trained to identify which cases had been perturbed. Performance was estimated using Monte-Carlo cross validation. Signature strength had the greatest influence on predictor performance. It was possible to develop almost perfect predictors with as few as 10 features if the fold difference in mean expression values were > 2 even when the spiked samples represented 10% of all samples. We also assessed the gene signature set size and strength for 9 real clinical prediction problems in six different breast cancer data sets. We found sufficiently large and strong predictive signatures only for distinguishing ER-positive from ER-negative cancers, there were no strong signatures for more subtle prediction problems. Current statistical methods efficiently identify highly informative features in gene expression data if such features exist and accurate models can be built with as few as 10 highly informative features. Features can be considered highly informative if at least 2-fold expression difference exists between comparison groups but such features do not appear to be common for many clinically relevant prediction problems in human data sets.
Mitchell, Aaron P; Hirsch, Bradford R; Abernethy, Amy P
Poor accrual is a significant barrier to the successful completion of oncology clinical trials; half of all phase 3 oncology trials close due to insufficient accrual. Timely access to accrual data fosters an understanding of successful trial design and can be used to inform the design of new clinical trials prospectively. Accrual statistics are available within research networks, such as the cancer cooperative groups, but comprehensive data reflecting the overall portfolio of cancer clinical trials are lacking. As a demonstration case, the purpose of this study was to quantify the public availability of accrual data across all recent renal cell carcinoma (RCC) trials. The database for the Aggregate Analysis of ClinicalTrials.gov (AACT) summarizes all trials registered between October 2007 and September 2010. In total, 108 trials of pharmacologic therapy for RCC were included. Accrual data on these trials were gathered via ClinicalTrials.gov (CTG), a manual review of resulting publications, and online surveys sent to principle investigators or trial coordinators. In total, 26% (20 of 76) of trials listing a government, academic, or cooperative group (GAC) sponsor responded to the survey vs 0% (0 of 32) of those listing only industry sponsors. Across all methods, accrual data were available for only 40% (43 of 108) of trials, including 37% (28 of 76) of GAC trials and 47% (15 of 32) of industry trials. Moreover, 87% (66 of 76) of GAC trials were ongoing (open, actively recruiting, or of unknown status) vs 75% (24 of 32) of industry trials, while 9% (10 of 108) of trials were terminated or suspended. Despite extensive efforts (surveys, phone calls, CTG abstraction, publication searches), accurate accrual data remained inaccessible for 60% of the RCC trial cohort. While CTG reports trial results, ongoing accrual data are also critically needed. Poor access to accrual data will continue to limit attempts to develop a national summary of clinical trials metrics and to
Brown, Benjamin; Balatsoukas, Panos; Williams, Richard; Sperrin, Matthew; Buchan, Iain
Electronic audit and feedback (e-A&F) systems are used worldwide for care quality improvement. They measure health professionals' performance against clinical guidelines, and some systems suggest improvement actions. However, little is known about optimal interface designs for e-A&F, in particular how to present suggested actions for improvement. We developed a novel theory-informed system for primary care (the Performance Improvement plaN GeneratoR; PINGR) that covers the four principal interface components: clinical performance summaries; patient lists; detailed patient-level information; and suggested actions. As far as we are aware, this is the first report of an e-A&F system with all four interface components. (1) Use a combination of quantitative and qualitative methods to evaluate the usability of PINGR with target end-users; (2) refine existing design recommendations for e-A&F systems; (3) determine the implications of these recommendations for patient safety. We recruited seven primary care physicians to perform seven tasks with PINGR, during which we measured on-screen behaviour and eye movements. Participants subsequently completed usability questionnaires, and were interviewed in-depth. Data were integrated to: gain a more complete understanding of usability issues; enhance and explain each other's findings; and triangulate results to increase validity. Participants committed a median of 10 errors (range 8-21) when using PINGR's interface, and completed a median of five out of seven tasks (range 4-7). Errors violated six usability heuristics: clear response options; perceptual grouping and data relationships; representational formats; unambiguous description; visually distinct screens for confusable items; and workflow integration. Eye movement analysis revealed the integration of components largely supported effective user workflow, although the modular design of clinical performance summaries unnecessarily increased cognitive load. Interviews and
Miller, Kristen; Mosby, Danielle; Capan, Muge; Kowalski, Rebecca; Ratwani, Raj; Noaiseh, Yaman; Kraft, Rachel; Schwartz, Sanford; Weintraub, William S; Arnold, Ryan
Provider acceptance and associated patient outcomes are widely discussed in the evaluation of clinical decision support systems (CDSSs), but critical design criteria for tools have generally been overlooked. The objective of this work is to inform electronic health record alert optimization and clinical practice workflow by identifying, compiling, and reporting design recommendations for CDSS to support the efficient, effective, and timely delivery of high-quality care. A narrative review was conducted from 2000 to 2016 in PubMed and The Journal of Human Factors and Ergonomics Society to identify papers that discussed/recommended design features of CDSSs that are associated with the success of these systems. Fourteen papers were included as meeting the criteria and were found to have a total of 42 unique recommendations; 11 were classified as interface features, 10 as information features, and 21 as interaction features. Features are defined and described, providing actionable guidance that can be applied to CDSS development and policy. To our knowledge, no reviews have been completed that discuss/recommend design features of CDSS at this scale, and thus we found that this was important for the body of literature. The recommendations identified in this narrative review will help to optimize design, organization, management, presentation, and utilization of information through presentation, content, and function. The designation of 3 categories (interface, information, and interaction) should be further evaluated to determine the critical importance of the categories. Future work will determine how to prioritize them with limited resources for designers and developers in order to maximize the clinical utility of CDSS. This review will expand the field of knowledge and provide a novel organization structure to identify key recommendations for CDSS.
Rolfes, Lean; van Hunsel, Florence; van der Linden, Laura; Taxis, Katja; van Puijenbroek, Eugene
Introduction Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. Objectives The aim was to determine to what extent
Zheng, Shuai; Lu, James J; Ghasemzadeh, Nima; Hayek, Salim S; Quyyumi, Arshed A; Wang, Fusheng
Extracting structured data from narrated medical reports is challenged by the complexity of heterogeneous structures and vocabularies and often requires significant manual effort. Traditional machine-based approaches lack the capability to take user feedbacks for improving the extraction algorithm in real time. Our goal was to provide a generic information extraction framework that can support diverse clinical reports and enables a dynamic interaction between a human and a machine that produces highly accurate results. A clinical information extraction system IDEAL-X has been built on top of online machine learning. It processes one document at a time, and user interactions are recorded as feedbacks to update the learning model in real time. The updated model is used to predict values for extraction in subsequent documents. Once prediction accuracy reaches a user-acceptable threshold, the remaining documents may be batch processed. A customizable controlled vocabulary may be used to support extraction. Three datasets were used for experiments based on report styles: 100 cardiac catheterization procedure reports, 100 coronary angiographic reports, and 100 integrated reports-each combines history and physical report, discharge summary, outpatient clinic notes, outpatient clinic letter, and inpatient discharge medication report. Data extraction was performed by 3 methods: online machine learning, controlled vocabularies, and a combination of these. The system delivers results with F1 scores greater than 95%. IDEAL-X adopts a unique online machine learning-based approach combined with controlled vocabularies to support data extraction for clinical reports. The system can quickly learn and improve, thus it is highly adaptable.
Thomsen, Kirsten Engelund; Wittchen, Kim Bjarne
This report collects energy performance requirements for existing buildings in European member states by June 2012.......This report collects energy performance requirements for existing buildings in European member states by June 2012....
that could be refurbished and recommence production for export of minerals such as magnesite and zinc. An example is given below in Figure 4.3...inefficient technology (such as making fertilizer from coal) should not
Gagnon, M-P; Pluye, P; Desmartis, M; Car, J; Pagliari, C; Labrecque, M; Frémont, P; Gagnon, J; Njoya, M; Légaré, F
This paper presents the evidence on the effectiveness of interventions promoting the use of clinical information retrieval technologies (CIRTs) by healthcare professionals. We electronically searched articles published between January 1990 and March 2008 using following inclusion criteria: (1) participants were healthcare professionals; (2) specific intervention promoted CIRT adoption; (3) studies were randomised controlled trials, controlled clinical trials, controlled before and after studies or interrupted time series analyses; and (4) they objectively reporting measured outcomes on CIRT use. We found nine studies focusing on CIRT use. Main outcomes measured were searching skills and/or frequency of use of electronic databases by healthcare professionals. Three studies reported a positive effect of the intervention on CIRT use, one showed a positive impact post-intervention, and four studies failed to demonstrate significant intervention effect. The ninth study examined financial disincentives, and found a significant negative effect of introducing user fees for searching MEDLINE in clinical settings. A meta-analysis showed that educational meetings were the only type of interventions reporting consistent positive effects on CIRT adoption. CIRT is an information and communication technology commonly used in healthcare settings. Interventions promoting CIRT adoption by healthcare professionals have shown some success in improving searching skills and use of electronic databases. However, the effectiveness of these interventions remains uncertain and more rigorous studies are needed. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
Wu, Jingjing; Wu, Xinming; Li, Pengfei; Li, Nan; Mao, Xiaomei; Chai, Lihe
Meridian system is not only the basis of traditional Chinese medicine (TCM) method (e.g. acupuncture, massage), but also the core of TCM's basic theory. This paper has introduced a new informational perspective to understand the reality and the holographic field of meridian. Based on maximum information entropy principle (MIEP), a dynamic equation for the holographic field has been deduced, which reflects the evolutionary characteristics of meridian. By using self-organizing artificial neural network as algorithm, the evolutionary dynamic equation of the holographic field can be resolved to assess properties of meridians and clinically diagnose the health characteristics of patients. Finally, through some cases from clinical patients (e.g. a 30-year-old male patient, an apoplectic patient, an epilepsy patient), we use this model to assess the evolutionary properties of meridians. It is proved that this model not only has significant implications in revealing the essence of meridian in TCM, but also may play a guiding role in clinical assessment of patients based on the holographic field of meridians.
Faiola, Anthony; Srinivas, Preethi; Duke, Jon
Advances in intensive care unit bedside displays/interfaces and electronic medical record (EMR) technology have not adequately addressed the topic of visual clarity of patient data/information to further reduce cognitive load during clinical decision-making. We responded to these challenges with a human-centered approach to designing and testing a decision-support tool: MIVA 2.0 (Medical Information Visualization Assistant, v.2). Envisioned as an EMR visualization dashboard to support rapid analysis of real-time clinical data-trends, our primary goal originated from a clinical requirement to reduce cognitive overload. In the study, a convenience sample of 12 participants were recruited, in which quantitative and qualitative measures were used to compare MIVA 2.0 with ICU paper medical-charts, using time-on-task, post-test questionnaires, and interviews. Findings demonstrated a significant difference in speed and accuracy with the use of MIVA 2.0. Qualitative outcomes concurred, with participants acknowledging the potential impact of MIVA 2.0 for reducing cognitive load and enabling more accurate and quicker decision-making.
Hoerbst, A; Schweitzer, M
Clinical Information Systems (CIS) have ever since the introduction of information technology in healthcare played an important role to support healthcare professionals and the process of treatment. With the rise of the concept of integrated care organizational borders, the sole focus on data aggregation or healthcare professionals as users disappear more and more. The manuscript discusses the concept of CISs and investigates critical success factors for CISs in the context of integrated care and in the course of time. In order to identify critical success factors and barriers for CISs a systematic literature review was conducted based on the results from PubMed and Cochrane, using MaxQDA. Search results were thereby limited to reviews or meta-analysis. We have found 1919 references of which 40 met the inclusion criteria. The analysis of the manuscripts resulted in a comprehensive list of success factors and barriers related to CISs in integrated care settings. Most barriers were user-related whereas for the success factors an even distribution of organizational, technical and user-related factors was observed. The vast majority of publications was focused on healthcare professionals. It is important to incorporate experiences made/ collected over time, as the problems encountered seem to remain almost unvaried. In order to support further systematic investigations on the topic it is necessary to rethink existing concepts and definitions to realign them with the ideas of integrated care.
The efficiency and acceptance of clinical decision support systems (CDSS) can increase if they reuse medical data captured during health care delivery. High heterogeneity of the existing legacy data formats has become the main barrier for the reuse of data. Thus, we need to apply data modeling mechanisms that provide standardization, transformation, accumulation and querying medical data to allow its reuse. In this paper, we focus on the interoperability issues of the hospital information systems (HIS) and CDSS data integration. Our study is based on the approach proposed by Marcos et al. where archetypes are used as a standardized mechanism for the interaction of a CDSS with an electronic health record (EHR). We build an integration tool to enable CDSSs collect data from various institutions without a need for modifications in the implementation. The approach implies development of a conceptual level as a set of archetypes representing concepts required by a CDSS. Treatment case data from Regional Clinical Hospital in Tomsk, Russia was extracted, transformed and loaded to the archetype database of a clinical decision support system. Test records' normalization has been performed by defining transformation and aggregation rules between the EHR data and the archetypes. These mapping rules were used to automatically generate openEHR compliant data. After the transformation, archetype data instances were loaded into the CDSS archetype based data storage. The performance times showed acceptable performance for the extraction stage with a mean of 17.428 s per year (3436 case records). The transformation times were also acceptable with 136.954 s per year (0.039 s per one instance). The accuracy evaluation showed the correctness and applicability of the method for the wide range of HISes. These operations were performed without interrupting the HIS workflow to prevent the HISes from disturbing the service provision to the users. The project results have proven that
To demonstrate the feasibility of a Web-based laboratory data browser integrated with heterogeneous clinical information in a hospital setting. A Java-based web application was developed in-house, using free open-source software. The server side manages queries to heterogeneous hospital databases containing patient data. Order entry information including laboratory test results, drug prescriptions, injection orders, physiological test orders and, imaging test orders, was retrieved from a replication database, and integrated with nursing data from a nursing system database. The result was visualized in a time-series table format, and accessed by web browsers on computers connected to the hospital intranet. The laboratory data browser system achieved practical response times over huge databases (> 90 million records). The medical personnel accepted the system well, and applied the system to various clinical situations. Integrating heterogeneous data from hospital databases in a Web-based laboratory data browser is a practical approach. Presenting relevant medical information simultaneously added value to the laboratory data, and may promote better medical management.
Pedroza, Claudia; Han, Weilu; Thanh Truong, Van Thi; Green, Charles; Tyson, Jon E
One of the main advantages of Bayesian analyses of clinical trials is their ability to formally incorporate skepticism about large treatment effects through the use of informative priors. We conducted a simulation study to assess the performance of informative normal, Student- t, and beta distributions in estimating relative risk (RR) or odds ratio (OR) for binary outcomes. Simulation scenarios varied the prior standard deviation (SD; level of skepticism of large treatment effects), outcome rate in the control group, true treatment effect, and sample size. We compared the priors with regards to bias, mean squared error (MSE), and coverage of 95% credible intervals. Simulation results show that the prior SD influenced the posterior to a greater degree than the particular distributional form of the prior. For RR, priors with a 95% interval of 0.50-2.0 performed well in terms of bias, MSE, and coverage under most scenarios. For OR, priors with a wider 95% interval of 0.23-4.35 had good performance. We recommend the use of informative priors that exclude implausibly large treatment effects in analyses of clinical trials, particularly for major outcomes such as mortality.
West, Peter; Van Kleek, Max; Giordano, Richard; Weal, Mark; Shadbolt, Nigel
A characteristic trend of digital health has been the dramatic increase in patient-generated data being presented to clinicians, which follows from the increased ubiquity of self-tracking practices by individuals, driven, in turn, by the proliferation of self-tracking tools and technologies. Such tools not only make self-tracking easier but also potentially more reliable by automating data collection, curation, and storage. While self-tracking practices themselves have been studied extensively in human-computer interaction literature, little work has yet looked at whether these patient-generated data might be able to support clinical processes, such as providing evidence for diagnoses, treatment monitoring, or postprocedure recovery, and how we can define information quality with respect to self-tracked data. In this article, we present the results of a literature review of empirical studies of self-tracking tools, in which we identify how clinicians perceive quality of information from such tools. In the studies, clinicians perceive several characteristics of information quality relating to accuracy and reliability, completeness, context, patient motivation, and representation. We discuss the issues these present in admitting self-tracked data as evidence for clinical decisions.
Gajjar, Amar; Bowers, Daniel C; Karajannis, Matthias A; Leary, Sarah; Witt, Hendrik; Gottardo, Nicholas G
Pediatric neuro-oncology has undergone an exciting and dramatic transformation during the past 5 years. This article summarizes data from collaborative group and institutional trials that have advanced the science of pediatric brain tumors and survival of patients with these tumors. Advanced genomic analysis of the entire spectrum of pediatric brain tumors has heralded an era in which stakeholders in the pediatric neuro-oncology community are being challenged to reconsider their current research and diagnostic and treatment strategies. The incorporation of this new information into the next-generation treatment protocols will unleash new challenges. This review succinctly summarizes the key advances in our understanding of the common pediatric brain tumors (ie, medulloblastoma, low- and high-grade gliomas, diffuse intrinsic pontine glioma, and ependymoma) and some selected rare tumors (ie, atypical teratoid/rhabdoid tumor and CNS primitive neuroectodermal tumor). The potential impact of this new information on future clinical protocols also is discussed. Cutting-edge genomics technologies and the information gained from such studies are facilitating the identification of molecularly defined subgroups within patients with particular pediatric brain tumors. The number of evaluable patients in each subgroup is small, particularly in the subgroups of rare diseases. Therefore, international collaboration will be crucial to draw meaningful conclusions about novel approaches to treating pediatric brain tumors. © 2015 by American Society of Clinical Oncology.
Bishop, Roderick O; Patrick, Jon; Besiso, Ali
This investigation was initiated after the introduction of a new information system into the Nepean Hospital Emergency Department. A retrospective study determined that the problems introduced by the new system led to reduced efficiency of the clinical staff, demonstrated by deterioration in the emergency department's (ED's) performance. This article is an investigation of methods to improve the design and implementation of clinical information systems for an ED by using a process of clinical team-led design and a technology built on a radically new philosophy denoted as emergent clinical information systems. The specific objectives were to construct a system, the Nepean Emergency Department Information Management System (NEDIMS), using a combination of new design methods; determine whether it provided any reduction in time and click burden on the user in comparison to an enterprise proprietary system, Cerner FirstNet; and design and evaluate a model of the effect that any reduction had on patient throughput in the department. The methodology for conducting a direct comparison between the 2 systems used the 6 activity centers in the ED of clerking, triage, nursing assessments, fast track, acute care, and nurse unit manager. A quantitative study involved the 2 systems being measured for their efficiency on 17 tasks taken from the activity centers. A total of 332 task instances were measured for duration and number of mouse clicks in live usage on Cerner FirstNet and in reproduction of the same Cerner FirstNet work on NEDIMS as an off-line system. The results showed that NEDIMS is at least 41% more efficient than Cerner FirstNet (95% confidence interval 21.6% to 59.8%). In some cases, the NEDIMS tasks were remodeled to demonstrate the value of feedback to create improvements and the speed and economy of design revision in the emergent clinical information systems approach. The cost of the effort in remodeling the designs showed that the time spent on remodeling is
Dereczyk, Amy; DeWitt, Rachel
This qualitative study explored the clinical experiences of students in an accelerated physician assistant (PA) program. The participants were either certified nursing assistants (CNAs) or emergency medical technicians-basic (EMTs-B). The study was designed to elicit (1) how the participants perceived their older patients and (2) how the participants' experiences might affect their own future communications, bedside manner, and clinical preparedness as PAs. This study used a focus group to explore students' clinical experiences before the graduate phase of their accelerated PA program. Five female and 2 male PA students (N = 7) participated in the study. All participants were 23 years old and worked as either a CNA or an EMT-B. Results fell into 2 basic themes: informing practice and forming relationships. Regarding the first theme, participants felt that their experience as entry-level health care providers allowed them to improve their communication skills and bedside manner and to provide greater comfort to patients. Regarding the second theme, participants gained appreciation for older people and began to recognize the knowledge deficits and learning needs of their patients. The results suggested that a student's clinical experience as a CNA or an EMT-B before entering a PA program has a positive effect on the student's personal and professional development. The participants acquired greater appreciation and respect for older patients and members of the health care team.
Wenzel, Jennifer A; Mbah, Olive; Xu, Jiayun; Moscou-Jackson, Gyasi; Saleem, Haneefa; Sakyi, Kwame; Ford, Jean G
Clinical trials are critical to advancing cancer treatment. Minority populations are underrepresented among trial participants, and there is limited understanding of their decision-making process and key determinants of decision outcomes regarding trial participation. To understand research decision-making among clinical trial-eligible African-American cancer patients at Johns Hopkins, we conducted seven focus groups (n=32) with trial-offered patients ≥ 18 years diagnosed with lung, breast, prostate, or colorectal cancer ≤ 5 years. Three "acceptor" and four "decliner" focus groups were conducted. Questions addressed: attitudes towards clinical trials, reasons for accepting or declining participation, and recommendations to improve minority recruitment and enrollment. Data were transcribed and analyzed using traditional approaches to content and thematic analysis in NVivo 9.0. Data coding resulted in themes that supported model construction. Participant experiences revealed the following themes when describing the decision-making process: Information gathering, Intrapersonal perspectives, and Interpersonal influences. Decision outcomes included the presence or absence of decision regret and satisfaction. From these themes, we generated a Model of Cancer Clinical Trial Decision-making. Our model should be tested in hypothesis-driven research to elucidate factors and processes influencing decision balance and outcomes of trial-related decision-making. The model should also be tested in other disparities populations and for diagnoses other than cancer.
Brammen, Dominik; Katzer, Christian; Röhrig, Rainer; Weismüller, Katja; Maier, Michael; Hossain, Hamid; Menges, Thilo; Hempelmann, Gunter; Chakraborty, Trinad
The development of medical research networks within the framework of translational research has fostered interest in the integration of clinical and biological research data in a common database. The building of one single database integrating clinical data and biological research data requires a concept which enables scientists to retrieve information and to connect known facts to new findings. Clinical parameters are collected by a Patient Data Management System and viewed in a database which also includes genomic data. This database is designed as an Entity Attribute Value model, which implicates the development of a data warehouse concept. For the realization of this project, various requirements have to be taken into account which has to be fulfilled sufficiently in order to align with international standards. Data security and protection of data privacy are most important parts of the data warehouse concept. It has to be clear how patient pseudonymization has to be carried out in order to be within the scope of data security law. To be able to evaluate the data stored in a database consisting of clinical data collected by a Patient Data Management System and genomic research data easily, a data warehouse concept based on an Entity Attribute Value datamodel has been developed.
Handler, Steven M.; Sharkey, Siobhan S.; Hudak, Sandra; Ouslander, Joseph G.
A substantial reduction in hospitalization rates has been associated with the implementation of the Interventions to Reduce Acute Care Transfers (INTERACT) quality improvement intervention using the accompanying paper-based clinical practice tools (INTERACT II). There is significant potential to further increase the impact of INTERACT by integrating INTERACT II tools into nursing home (NH) health information technology (HIT) via standalone or integrated clinical decision support (CDS) systems. This article highlights the process of translating INTERACT II tools from paper to NH HIT. The authors believe that widespread dissemination and integration of INTERACT II CDS tools into various NH HIT products could lead to sustainable improvement in resident and clinician process and outcome measures, including enhanced interclinician communication and a reduction in potentially avoidable hospitalizations. PMID:22267955
Tong, Allison; Morton, Rachael L; Webster, Angela C
Patient-centered care is no longer just a buzzword. It is now widely touted as a cornerstone in delivering quality care across all fields of medicine. However, patient-centered strategies and interventions necessitate evidence about patients' decision-making processes, values, priorities, and needs. Qualitative research is particularly well suited to understanding the experience and perspective of patients, donors, clinicians, and policy makers on a wide range of transplantation-related topics including organ donation and allocation, adherence to prescribed therapy, pretransplant and posttransplant care, implementation of clinical guidelines, and doctor-patient communication. In transplantation, evidence derived from qualitative research has been integrated into strategies for shared decision-making, patient educational resources, process evaluations of trials, clinical guidelines, and policies. The aim of this article is to outline key concepts and methods used in qualitative research, guide the appraisal of qualitative studies, and assist clinicians to understand how qualitative research may inform their practice and policy.
I. V. Tolmachyov
Full Text Available There is the big issue in medical education which is students don’t have enough skills. Often even with theoretical knowledge graduate medical students need to improve their skills by working with patients. Obviously it can be a risk for patients and takes quite long time. This situation could be changed with applying simulation technologies in medical education. Medical education with virtual simulators allows reducing the time of skills development and improving the quality of training. The aims of this work are developing informational model and creating clinical scenarios of emergency states in the Medical Simulation Center.Objectives:– to analyze the process of scenario conducting;– to create clinical scenarios of emergency states (anaphylactic shock, hypovolemic shock, obstructive shock with specialist’s help.The scenarios consist of sections such as main aim, skills, required mannequins, preparation of the mannequins, preparation of medical equipment and instruments for the scenario, preparation of special materials, scenario description, guide for operator, information for trainees.By analyzing the process of scenario conducting the key participants were defined who are operator, assistant, trainer, trainees. Also the main scenario stages were defined. Based on the stages diagram of variants of scenario conducting was designed.As an example there are fragments of scenario “Obstructive shock – a pulmonary embolism” in this article. Learn skills are cognitive, technical, social ones.Results. This paper presents an analysis of the clinical scenario conducting. Information model was developed which based on object-oriented decomposition. The model is the diagram of variants of scenario conducting. Scenario’s structure for emergency states was formulated. The scenarios are anaphylactic shock, hypovolemic shock, obstructive shock (pulmonary embolism, tension pneumothorax, pulmonary edema, hypertensive crisis, respiratory
Callen, Joanne; Braithwaite, J; Westbrook, Johanna I
To measure doctors' and nurses' perceptions of organisational culture and relate this to their attitudes to, and satisfaction with, a hospital-wide mandatory computerised provider order entry (CPOE) system in order to illuminate cultural compositions in CPOE use. A cross-sectional survey design was employed. Data were collected by administering an organisational culture survey (Organisational Culture Inventory, OCI) along with a user-satisfaction survey to a population of 103 doctors and nurses from two clinical units in an Australian metropolitan teaching hospital. Clinicians from the hospital had used the CPOE system since 1991 to order and view clinical laboratory and radiology tests electronically for all patients. The OCI provides a measure of culture in terms of three general styles which distinguish between: constructive; passive/defensive, and aggressive/defensive cultures. The cluster which best describes the overall culture is the one that has the highest percentile score when the percentile scores of the four cultural norms included in the cluster are averaged. The user satisfaction survey asked questions relating to satisfaction with, and attitudes to, the system. We found identifiable sub-cultures based on professional divisions where doctors perceived an aggressive-defensive culture (mean percentile score = 43.8) while nurses perceived a constructive culture (mean percentile score = 61.5). There were significant differences between doctors and nurses on three of the attitude variables with nurses expressing more positive views towards CPOE than doctors. The manifestation of sub-cultures within hospitals and the impact this has on attitudes towards clinical information systems should be recognized and addressed when planning for system implementation. Identification and management of the cultural characteristics of different groups of health professionals may facilitate the successful implementation and use of clinical information systems.
Funk, Russell J; Owen-Smith, Jason; Kaufman, Samuel A; Nallamothu, Brahmajee K; Hollingsworth, John M
To reduce inefficiency and waste associated with care fragmentation, many current programs target greater clinical integration among physicians. However, these programs have led to only modest Medicare spending reductions. Most programs focus on formal integration, which often bears little resemblance to actual physician interaction patterns. To examine how physician interaction patterns vary between health systems and to assess whether variation in informal integration is associated with care delivery payments. National Medicare data from January 1, 2008, through December 31, 2011, identified 253 545 Medicare beneficiaries (aged ≥66 years) from 1186 health systems where Medicare beneficiaries underwent coronary artery bypass grafting (CABG) procedures. Interactions were mapped between all physicians who treated these patients-including primary care physicians and surgical and medical specialists-within a health system during their surgical episode. The level of informal integration was measured in these networks of interacting physicians. Multivariate regression models were fitted to evaluate associations between payments for each surgical episode made on a beneficiary's behalf and the level of informal integration in the health system where the patient was treated. The informal integration level of a health system. Price-standardized total surgical episode and component payments. The total 253 545 study participants included 175 520 men (69.2%; mean [SD] age, 74.51 [5.75] years) and 78 024 women (34.3%; 75.67 [5.91] years). One beneficiary of the 253 545 participants did not have sex information. The low level of informal clinical integration included 84 598 patients (33.4%; mean [SD] age, 75.00 [5.93] years); medium level, 84 442 (33.30%; 74.94 [5.87] years); and high level, 84 505 (33.34%; 74.66 [5.72] years) (P integration levels varied across health systems. After adjusting for patient, health-system, and community factors, higher levels
Peters, Todd E
Compared with other medical specialties, psychiatrists have been slower adopters of health information technology (IT) practices, such as electronic health records (EHRs). This delay in implementation could compromise patient safety and impede integration into accountable care organizations and multidisciplinary treatment settings. This article focuses on optimizing use of EHRs for clinical practice, leveraging health IT to improve quality of care, and focusing on the potential for future growth in health IT in child and adolescent psychiatric practice. Aligning with other medical fields and focusing on transparency of mental health treatment will help psychiatrists reach parity with other medical specialties. Copyright © 2016 Elsevier Inc. All rights reserved.
Bennett, Wendy L; Robbins, Craig W; Bayliss, Elizabeth A; Wilson, Renee; Tabano, Heather; Mularski, Richard A; Chan, Wiley V; Puhan, Milo; Yu, Tsung; Leff, Bruce; Li, Tianjing; Dickersin, Kay; Glover, Carol; Maslow, Katie; Armacost, Karen; Mintz, Suzanne; Boyd, Cynthia M
Having more than one chronic condition is common and is associated with greater health care utilization, higher medication burden and complexity of treatment. However, clinical practice guidelines (CPGs) do not routinely address the balance between harms and benefits of treatments for people with multiple chronic conditions (MCCs). To partner with the Kaiser Permanente Integrated Cardiovascular Health (ICVH) program to engage multiple stakeholders in a mixed-methods approach in order to: 1) identify two high-priority clinical questions related to MCCs, and 2) understand patients' and family caregivers' perceptions of meaningful outcomes to inform benefit/harm assessments for these two high-priority questions. These clinical questions and outcomes will be used to inform CPG recommendations for people with MCCs. DESIGN AND PARTICIPANTS: The ICVH program provided 130 topics rank-ordered by the potential for finding evidence that would change clinical recommendations regarding the topic. We used a modified Delphi method to identify and reword topics into questions relevant to people with MCCs. We used two sets of focus groups (n = 27) to elicit patient and caregiver perspectives on two important research questions and relevant patient-important outcomes on benefit/harm balance for people with MCCs. Co-investigators, patients and caregivers identified "optimal blood pressure goals" and "diabetes medication management" as important clinical topics for CPGs related to people with MCCs. Stakeholders identified a list of relevant outcomes to be addressed in future CPG development including 1) physical function and energy, 2) emotional health and well-being, 3) avoidance of treatment burden, side effects and risks, 4) interaction with providers and health care system, and 5) prevention of adverse long-term health outcomes. Through the application of a mixed-methods process, we identified the questions regarding optimal blood pressure goals and diabetes medication management
Skyum, Florence; Abed, Osama Karim; Backer Mogensen, Christian
INTRODUCTION: The number of admissions for acute gastroenteritis (GE) is increasing. The majority of patients pass through a single high-flow emergency department (ED) area which increases the risk of spreading GE. The aim of this study was to determine the frequency and aetiology of GE for acutely...... admitted patients and to analyse their clinical information focusing on risk indicators of contagious aetiology and on the chosen isolation regime to determine if the GE required a contact precaution isolation regime. MATERIAL AND METHODS: This study included patients above 16 years of age who were...... admitted acutely within a one-year study period to a Danish hospital with a catchment population of 231,000 persons. The following items were analysed: information from the referring doctor, diarrhoea, nausea and vomiting and fever history, abdominal pain, prior antibiotics, co-morbidity, drugs, travel...
Atlas, Michel C; Smigielski, Elizabeth M; Wulff, Judith L; Coleman, Mary T
In primary care specialties, Morning Report is a traditional vehicle for expanding medical residents' training in diagnosis and treatment. At one academic medical center, residents and faculty in the Department of Family and Community Medicine use case-based teaching, centered around planning and reviewing patient management, to review intriguing cases from patient encounters in the department's hospital service. Seeking to improve the level of evidence-based information exchanged at Morning Report, department leaders invited reference librarians from the health sciences library to attend weekly Morning Report. The librarians saw this as an opportunity not only to improve residents' information-seeking skills, but also to improve librarians' teaching skills and understanding of the needs of users in clinical settings. This paper describes the evolution of librarians' involvement in Morning Report, examples of the kinds of contributions librarians have made in this setting, and changes made in Morning Report sessions to facilitate this activity.
Poulos, Christopher J; Gazibarich, Boris M; Eagar, Kathy
Providing information technology solutions to clinicians to support their work practices benefits clinicians, administrators and patients. We present our 8-year experience with an inexpensive information management system which provides clinical and business process support for clinicians and bed managers. The system has been used by an area rehabilitation and aged care service to manage inpatient consultations and patient flow across nine hospitals. Performance monitoring of the time from referral to consultation, the number, type and outcome of consultations, and the time taken to access a rehabilitation or subacute bed is also provided. Read-only access to the system for clinicians and bed managers outside the rehabilitation and aged care service allows greater transparency.
Shea, Steven; Clark, Anthony S.; Clayton, Paul D.
We describe a clinical information system for hospital-based ambulatory care implemented in the context of the institution's IAIMS Phase III effort. Key features of this application are physician data entry to maintain summary clinical profiles that include medication lists, problem lists, and preventive care, and integration with other components of the Clinical Information System at the levels of the database, the user interface, and data sharing. A goal of this application is to provide coded data as a substrate for computer-based decision support.
Ketchum, Andrea M; Saleh, Ahlam A; Jeong, Kwonho
Point-of-care (POC) products are widely used as information reference tools in the clinical setting. Although usability, scope of coverage, ability to answer clinical questions, and impact on health outcomes have been studied, no comparative analysis of the characteristics of the references, the evidence for the content, in POC products is available. The objective of this study was to compare the type of evidence behind five POC clinical information products. This study is a comparative bibliometric analysis of references cited in monographs in POC products. Five commonly used products served as subjects for the study: ACP PIER, Clinical Evidence, DynaMed, FirstCONSULT, and UpToDate. The four clinical topics examined to identify content in the products were asthma, hypertension, hyperlipidemia, and carbon monoxide poisoning. Four indicators were measured: distribution of citations, type of evidence, product currency, and citation overlap. The type of evidence was determined based primarily on the publication type found in the MEDLINE bibliographic record, as well as the Medical Subject Headings (MeSH), both assigned by the US National Library of Medicine. MeSH is the controlled vocabulary used for indexing articles in MEDLINE/PubMed. FirstCONSULT had the greatest proportion of references with higher levels of evidence publication types such as systematic review and randomized controlled trial (137/153, 89.5%), although it contained the lowest total number of references (153/2330, 6.6%). DynaMed had the largest total number of references (1131/2330, 48.5%) and the largest proportion of current (2007-2009) references (170/1131, 15%). The distribution of references cited for each topic varied between products. For example, asthma had the most references listed in DynaMed, Clinical Evidence, and FirstCONSULT, while hypertension had the most references in UpToDate and ACP PIER. An unexpected finding was that the rate of citation overlap was less than 1% for each topic
Dias, Joana; Martins, Sofia; Carvalho, Susana; Marques, Olinda; Antunes, Ana
Mauriac syndrome (MS) is a rare complication of type 1 diabetes mellitus (DM1). It is related to low insulin concentrations and is less common since longer-acting insulins became available. It is characterized by hepatomegaly, growth and puberty delay, and the presence of elevated transaminases and serum lipids. The aim of this study was to describe the patients from a pediatric diabetic population that fulfill the criteria of MS. A retrospective analysis of the pediatric diabetic population with diagnostic criteria of MS currently followed at Hospital de Braga, was performed. From a population of 91 patients with DM1 18 years, 6 patients with the criteria for MS were identified: 5 girls, and 1 boy. The age at presentation was 13-17 years, with a minimum interval between DM1 diagnosis and MS criteria of 4 years. All the patients were prescribed intensive insulin therapy (median daily insulin dose: 0.88 U/kg). All had a previous history of poor glycemic control before the diagnosis of MS with glycated hemoglobin (HbA1c) between 8.8 and 12.9%. Increase of hepatic enzymes was present in all the patients; 4 of them had associated hepatomegaly. All the girls presented puberty delay and cushingoid features. None of the patients presented short stature and 5 of them presented mixed dyslipidemia. Although MS is an ancient entity described in DM1, it still exists, particularly in adolescent females. Being aware of MS is of extreme importance since most of the clinical features are reversible with better glycemic control. Copyright © 2012 SEEN. Published by Elsevier Espana. All rights reserved.
Stitt, F W
To create a clinical data repository to interface the Veteran's Administration (VA) Decentralized Hospital Computer Program (DHCP) and a departmental clinical information system for the management of HIV patients. This system supports record-keeping, decision-making, reporting, and analysis. The database development was designed to overcome two impediments to successful implementations of clinical databases: (i) lack of a standard reference data model, and; (ii) lack of a universal standard for medical concept representation. Health Level Seven (HL7) is a standard protocol that specifies the implementation of interfaces between two computer applications (sender and receiver) from different vendors or sources of electronic data exchange in the health care environment. This eliminates or substantially reduces the custom interface programming and program maintenance that would otherwise be required. HL7 defines the data to be exchanged, the timing of the interchange, and the communication of errors to the application. The formats are generic in nature and must be configured to meet the needs of the two applications involved. The standard conceptually operates at the seventh level of the ISO model for Open Systems Interconnection (OSI). The OSI simply defines the data elements that are exchanged as abstract messages, and does not prescribe the exact bit stream of the messages that flow over the network. Lower level network software developed according to the OSI model may be used to encode and decode the actual bit stream. The OSI protocols are not universally implemented and, therefore, a set of encoding rules for defining the exact representation of a message must be specified. The VA has created an HL7 module to assist DHCP applications in exchanging health care information with other applications using the HL7 protocol. The DHCP HL7 module consists of a set of utility routines and files that provide a generic interface to the HL7 protocol for all DHCP applications
Pedersen, Alma B; Mehnert, Frank; Odgaard, Anders
We described the settings, organization, content, and data quality of the Danish Knee Arthroplasty Register (DKR), as well as the incidence and the first results of the knee replacement procedures captured by the DKR. Our aim was to draw researchers' attention to the DKR and its potential use...
Langagergaard, Vivian; Garne, Jens P; Vejborg, Ilse
in the first round, and data regarding radiation dose were not available at the time of evaluation. Overall, the quality indicators showed satisfactory quality in the first round of national breast cancer screening in Denmark. The DKMS is a potentially valuable tool for improving quality and conducting...
Veinot, Tiffany C; Senteio, Charles R; Hanauer, David; Lowery, Julie C
To describe a new, comprehensive process model of clinical information interaction in primary care (Clinical Information Interaction Model, or CIIM) based on a systematic synthesis of published research. We used the "best fit" framework synthesis approach. Searches were performed in PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Library and Information Science Abstracts, Library, Information Science and Technology Abstracts, and Engineering Village. Two authors reviewed articles according to inclusion and exclusion criteria. Data abstraction and content analysis of 443 published papers were used to create a model in which every element was supported by empirical research. The CIIM documents how primary care clinicians interact with information as they make point-of-care clinical decisions. The model highlights 3 major process components: (1) context, (2) activity (usual and contingent), and (3) influence. Usual activities include information processing, source-user interaction, information evaluation, selection of information, information use, clinical reasoning, and clinical decisions. Clinician characteristics, patient behaviors, and other professionals influence the process. The CIIM depicts the complete process of information interaction, enabling a grasp of relationships previously difficult to discern. The CIIM suggests potentially helpful functionality for clinical decision support systems (CDSSs) to support primary care, including a greater focus on information processing and use. The CIIM also documents the role of influence in clinical information interaction; influencers may affect the success of CDSS implementations. The CIIM offers a new framework for achieving CDSS workflow integration and new directions for CDSS design that can support the work of diverse primary care clinicians.
Breeze, J; Fryer, R; Hare, J; Delaney, R; Hunt, N C; Lewis, E A; Clasper, J C
There is a requirement in the Ministry of Defence for an objective method of comparing the area of coverage of different body armour designs for future applications. Existing comparisons derived from surface wound mapping are limited in that they can only demonstrate the skin entry wound location. The Coverage of Armour Tool (COAT) is a novel three-dimensional model capable of comparing the coverage provided by body armour designs, but limited information exists as to which anatomical structures require inclusion. The aim of this study was to assess the utility of COAT, in the assessment of neck protection, using clinically relevant injury data. Hospital notes and post mortem records of all UK soldiers injured by an explosive fragment to the neck between 01 Jan 2006 and 31 December 2012 from Iraq and Afghanistan were analysed to determine which anatomical structures were responsible for death or functional disability at one year post injury. Using COAT a comparison of three ballistic neck collar designs was undertaken with reference to the percentage of these anatomical structures left exposed. 13/81 (16%) survivors demonstrated complications at one year, most commonly upper limb weakness from brachial plexus injury or a weak voice from laryngeal trauma. In 14/94 (15%) soldiers the neck wound was believed to have been the sole cause of death, primarily from carotid artery damage, spinal cord transection or rupture of the larynx. COAT objectively demonstrated that despite the larger OSPREY collar having almost double the surface area than the two-piece prototype collar, the percentage area of vulnerable cervical structures left exposed only reduced from 16.3% to 14.4%. COAT demonstrated its ability to objectively quantify the potential effectiveness of different body armour designs in providing coverage of vulnerable anatomical structures from different shot line orientations. To improve its utility, it is recommended that COAT be further developed to enable weapon
Hammarberg, Karin; Prentice, Tess; Purcell, Isabelle; Johnson, Louise
Many factors influence the chance of having a baby with assisted reproductive technologies (ART). A 2016 Australian Competition and Consumer Commission (ACCC) investigation concluded that ART clinics needed to improve the quality of information they provide about chance of ART success. To evaluate changes in the quality of information about success rates provided on the websites of ART clinics in Australia and New Zealand before and after the ACCC investigation. Desktop audits of websites of ART clinics in Australia and New Zealand were conducted in 2016 and 2017 and available information about success rates was scored using a matrix with eight variables and a possible range of scores of 0-9. Of the 54 clinic websites identified in 2016, 32 had unique information and were eligible to be audited. Of these, 29 were also eligible to be audited in 2017. While there was a slight improvement in the mean score from 2016 to 2017 (4.93-5.28), this was not statistically significantly different. Of the 29 clinics, 14 had the same score on both occasions, 10 had a higher and five a lower information quality score in 2017. To allow people who consider ART to make informed decisions about treatment they need comprehensive and accurate information about what treatment entails and what the likely outcomes are. As measured by a scoring matrix, most ART clinics had not improved the quality of the information about success rates following the ACCC investigation. © 2017 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
Park, Tae Woo; Lin, Lewei Allison; Hosanagar, Avinash; Kogowski, Amanda; Paige, Katie; Bohnert, Amy S B
Overdoses involving opioid analgesics represent a significant public health problem in the United States. We reviewed the literature on risk factors for overdose, with a focus on studies that examine clinical populations of patients receiving opioids for pain and potential risk factors for overdose in these populations. A structured review resulted in 15 articles published between 2007 and 2015 that examined risk factors for fatal and nonfatal overdose in patients receiving opioid analgesics. Opioid dosage was the factor most consistently analyzed and also associated with increased risk of overdose. Other risk factors include concurrent use of sedative-hypnotics, use of extended-release/long-acting opioids, and the presence of substance use and other mental health disorder comorbidities. Future research is needed to better characterize populations taking opioids for pain to help clarify discrepancies between existing studies and identify previously unexplored risk factors for overdose. Given that policy and clinical practice have shifted as a result of prior studies reviewed here, further efforts in understanding patient groups and opioid-related prescribing practices associated with overdose risk have great potential to impact policy and practice in the treatment of pain while improving the safety around opioid prescribing.
Combi, C; Pinciroli, F; Pozzi, G
In the field of databases, time management at different levels of granularity has been an issue for several years, for instance when dealing with clinical information from different databases using different time units, dealing with natural language expressions, or when dealing with temporal uncertainty. A temporal data model is proposed to manage the temporal aspect of data, presented at various and mixed levels of granularity. The concept of temporal assertions shapes the entire temporal information. The model provides a temporal dimension to the data by using intervals that can be specified at different granularities. The model supports a three-valued logic, where True, False and Undefined are the truth values. The temporal data model allows to manage some degrees of uncertainty when establishing temporal relationships between intervals or between temporal assertions, expressed at different granularities. The logical connectives and quantifiers can manage each of the three truth-values. We applied the temporal data model by implementing an object-oriented database system for managing follow-up clinical data from patients who underwent percutaneous transluminal coronary angioplasty.
Meadows, Anthony; Wimpenny, Katherine
Although clinical improvisation continues to be an important focus of music therapy research and practice, less attention has been given to integrating qualitative research in this area. As a result, this knowledge base tends to be contained within specific areas of practice rather than integrated across practices and approaches. This qualitative research synthesis profiles, integrates, and re-presents qualitative research focused on the ways music therapists and clients engage in, and make meaning from, clinical improvisation. Further, as a conduit for broadening dialogues, opening up this landscape fully, and sharing our response to the analysis and interpretation process, we present an arts-informed re-presentation of this synthesis. Following an eight-step methodological sequence, 13 qualitative studies were synthesized. This included reciprocal and refutational processes associated with synthesizing the primary studies, and additional steps associated with an arts-informed representation. Three themes, professional artistry, performing self, and meaning-making, are presented. Each theme is explored and exemplified through the selected articles, and discussed within a larger theoretical framework. An artistic re-presentation of the data is also presented. Music therapists use complex frameworks through which to engage clients in, and make meaning from, improvisational experiences. Artistic representation of the findings offers an added dimension to the synthesis process, challenging our understanding of representation, and thereby advancing synthesis methodology.
Eric G. Devine
Full Text Available Clinical trials within the US face an increasing challenge with the recruitment of quality candidates. One readily available group of subjects that have high rates of participation in clinical research are subjects who enroll in multiple trials for the purpose of generating income through study payments. Aside from issues of safety and generalizability, evidence suggests that these subjects employ methods of deception to qualify for the strict entrance criteria of some studies, including concealing information and fabricating information. Including these subjects in research poses a significant risk to the integrity of data quality and study designs. Strategies to limit enrollment of subjects whose motivation is generating income have not been systematically addressed in the literature. The present paper is intended to provide investigators with a range of strategies for developing and implementing a study protocol with protections to minimize the enrollment of subjects whose primary motivation for enrolling is to generate income. This multifaceted approach includes recommendations for advertising strategies, payment strategies, telephone screening strategies, and baseline screening strategies. The approach also includes recommendations for attending to inconsistent study data and subject motivation. Implementing these strategies may be more or less important depending upon the vulnerability of the study design to subject deception. Although these strategies may help researchers exclude subjects with a higher rate of deceptive practices, widespread adoption of subject registries would go a long way to decrease the chances of subjects enrolling in multiple studies or more than once in the same study.
Sioutos, Nicholas; de Coronado, Sherri; Haber, Margaret W; Hartel, Frank W; Shaiu, Wen-Ling; Wright, Lawrence W
Over the last 8 years, the National Cancer Institute (NCI) has launched a major effort to integrate molecular and clinical cancer-related information within a unified biomedical informatics framework, with controlled terminology as its foundational layer. The NCI Thesaurus is the reference terminology underpinning these efforts. It is designed to meet the growing need for accurate, comprehensive, and shared terminology, covering topics including: cancers, findings, drugs, therapies, anatomy, genes, pathways, cellular and subcellular processes, proteins, and experimental organisms. The NCI Thesaurus provides a partial model of how these things relate to each other, responding to actual user needs and implemented in a deductive logic framework that can help maintain the integrity and extend the informational power of what is provided. This paper presents the semantic model for cancer diseases and its uses in integrating clinical and molecular knowledge, more briefly examines the models and uses for drug, biochemical pathway, and mouse terminology, and discusses limits of the current approach and directions for future work.
Jagannathan, V; Mullett, Charles J; Arbogast, James G; Halbritter, Kevin A; Yellapragada, Deepthi; Regulapati, Sushmitha; Bandaru, Pavani
We assessed the current state of commercial natural language processing (NLP) engines for their ability to extract medication information from textual clinical documents. Two thousand de-identified discharge summaries and family practice notes were submitted to four commercial NLP engines with the request to extract all medication information. The four sets of returned results were combined to create a comparison standard which was validated against a manual, physician-derived gold standard created from a subset of 100 reports. Once validated, the individual vendor results for medication names, strengths, route, and frequency were compared against this automated standard with precision, recall, and F measures calculated. Compared with the manual, physician-derived gold standard, the automated standard was successful at accurately capturing medication names (F measure=93.2%), but performed less well with strength (85.3%) and route (80.3%), and relatively poorly with dosing frequency (48.3%). Moderate variability was seen in the strengths of the four vendors. The vendors performed better with the structured discharge summaries than with the clinic notes in an analysis comparing the two document types. Although automated extraction may serve as the foundation for a manual review process, it is not ready to automate medication lists without human intervention.
... the inclusion of work information in the electronic health record (EHR). NIOSH requests input on these... information in the EHR. The committee concluded that inclusion of occupational information in the EHR ``could..., disabled, retired, part time/full time, shift) Patient's current occupation(s) Patient's current industry(s...
Brown, Richard; Bylund, Carma L; Siminoff, Laura A; Slovin, Susan F
Phase I clinical trials are the gateway to effective new cancer treatments. Many physicians have difficulty when discussing Phase I clinical trials. Research demonstrates evidence of suboptimal communication. Little is known about communication strategies used by oncologists when recruiting patients for Phase I trials. We analyzed audio recorded Phase I consultations to identify oncologists' communication strategies. Subjects were consecutive cancer patients from six medical oncologists attending one of three outpatient clinics at a major Cancer Center in the United States. Sixteen patients signed informed consent for audio recording of their consultations in which a Phase I study was discussed. These were transcribed in full and analyzed to identify communication strategies. Six communication themes emerged from the analysis: (1) orienting, (2) educating patients, (3) describing uncertainty and prognosis, (4) persuading, (5) decision making, and (6) making a treatment recommendation. As expected, although there was some common ground between communication in Phase I and the Phase II and III settings, there were distinct differences. Oncologists used persuasive communication, made explicit recommendations, or implicitly expressed a treatment preference and were choice limiting. This highlights the complexity of discussing Phase I trials and the need to develop strategies to aid oncologists and patients in these difficult conversations. Patient centered communication that values patient preferences while preserving the oncologist's agenda can be a helpful approach to these discussions. Copyright © 2010 John Wiley & Sons, Ltd.
Higgins, Peter D R
Distinguishing fibrosis from inflammation in an intestinal stricture in Crohn's disease is quite difficult. The absence of signs of inflammation on CT or MRI does not prove the absence of inflammation, as most strictures have a mix of fibrosis and inflammation. Identifying refractory fibrosis and distinguishing the patients who will respond to anti-inflammatory therapy from those who will require surgery are important clinical requirements, and several new technologies in imaging and serum biomarkers are being applied to this problem. Key Messages: Delayed gadolinium enhancement of a Crohn's disease stricture on MRI can reliably identify severe fibrosis, and may be helpful in deciding which patients will require surgery. However, this approach does not appear to be able to identify patients with mild or moderate fibrosis. New imaging technologies, including T2/magnetization transfer MRI, shear wave velocity ultrasound, and photoacoustic imaging, offer promising animal data that could prove to accurately assist clinical decision making. Glyoproteomics has identified hepatic growth factor alpha and cartilage oligomeric matrix protein as possible serum biomarkers to detect and measure intestinal fibrosis. The presence of upstream small bowel dilation >3.5 cm or a platelet/albumin ratio >150 helps in identifying Crohn's disease patients at high risk of stricture resection in the next 2 years. Imaging and biomarker technologies to measure intestinal fibrosis are rapidly evolving, and could soon provide valuable information for clinical decision making for patients with intestinal strictures from Crohn's disease. © 2017 S. Karger AG, Basel.
Marta-Moreno, Javier; Obón-Azuara, Blanca; Gimeno-Felíu, Luis; Achkar-Tuglaman, Nesib Nicolás; Poblador-Plou, Beatriz; Calderón-Larrañaga, Amaia; Prados-Torres, Alexandra
The objective of this work was to analyse the concordance in the registry of dementia among the main sources of clinical information, with the aim of determining their usefulness for epidemiological and clinical research. Descriptive study of patients assigned to the Aragon Health Service in 2010 (n=1,344,891). (i)the pharmacy billing database (n=9,392); (ii)Primary Care electronic health records (EHR) (n=9,471), and (iii)the hospital minimum basic data set (n=3,289). When studying the concordance of the databases, the group of patients with a specific treatment for dementia (i.e., acetylcholinesterase inhibitors and/or memantine) was taken as the reference. The diagnosis in Primary Care was missing for 47.3% of patients taking anti-dementia drugs. The same occurred with 38.3% of dementia patients admitted to hospital during the study year. Among patients with a diagnosis of dementia in the EHR, only half (52.3%) was under treatment for this condition. This percentage decreased to 34.4% in patients with the diagnosis registered in the hospital database. The weak concordance in the registry of the dementia diagnosis between the main health information systems makes their use and analysis more complex, and supports the need to include all available health data sources in order to gain a global picture of the epidemiological and clinical reality of this health condition. Copyright © 2015 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.
Full Text Available With the purpose to evaluate diagnostic efficacy of some clinical symptoms of acute appendicitis 75 women in different terms of pregnancy were examined. Informative content of such symptoms as Kocher- Volkovich, Rovsing, Bartomje - Michelson, Sitkovsky, Gabay, Brendo, Michelson, Ivanov was studied. Pain syndrome was fixed in all examined women. Pain localization was various and depended on the pregnancy term. During the I trimester of pregnancy the most often pain was manifestated in epigastrium and right lower quadrant, rarely in other abdomen regions. In the II trimester in majority of cases pain occurred in right lower quadrant. During III trimester pain prevailed in right upper quadrant of abdomen. Analyzing informative component of researching symptoms there was noted significant decrease (р<0,05; р<0,01; р<0,001 of their diagnostic value with growth of pregnancy term. Therefore Kocher – Volkovich and Rovsing symptoms were the most informative in the I trimester of pregnancy. Diagnostic efficacy of Brendo(67,3%, Michelson(55,7%, Ivanov(59,6% symptoms was higher than that of Kocher – Volkovich (36,5%, Rovsing (28,8%, Sitkovsky (51,9%, Bartomje – Michelson (55,7% symptoms, their value was diminishing together with increase of pregnancy terms.
With the world's population aging, there is an increase in the number of demented elderly. It is vital to study this phenomenon in epidemiological and clinical studies, particularly the effects on the increasing numbers of demented elderly. Researchers need to understand the factors predicting the general decline in the demented elderly. However, before any research is undertaken, it is necessary to obtain approval from the Local Internal Review Board. This committee is responsible to maintain accepted national and international ethical standards. The basis for recruitment to a study is the signature on the informed consent form, where the patient is required to understand the study, internalize the study's aim, to consider all options and finally, to express an opinion. Potential elderly participants need to have their judgment evaluated before signing the form. In cases where the subject is incapable, some countries, including Israel, require that there be a legal guardianship. This is a long and complicated process that causes researchers not to recruit demented patients into a study which may actually be beneficial to all. Some countries allow a proxy to sign informed consent forms to permit the demented subject to participate in the study. Often the threshold may depend on the invasiveness of the intervention. The problem of proxies to sign informed consent form troubles researchers worldwide. This article addresses the history and development of ethics in research, and raises the issue to promote an official policy for proxy consent signing.
Hadji, Brahim; Dupuis, Isabelle; Leneveut, Laurence; Heudes, Didier; Wagner, Jean-François; Degoulet, Patrice
The evaluation of end-user satisfaction is an essential part of any clinical information system (CIS) project. The purpose of this study is to evaluate the determinants of CIS continuance intention in a late post-adoption phase at the Georges Pompidou University Hospital (HEGP) in Paris. We designed an electronic survey instrument based on an IT post-adoption model (ITPAM) developed from three previous models, i.e., the Delone and McLean Information Success Model, the Davis TAM model and the Bhattacherjee information system continuance intention model. 419 questionnaires were collected from CIS users directly involved in patient care. The perceived CIS quality, usefulness and user satisfaction are significantly lower for medical professions than other professional groups. Continuance intention is very high within all professional subgroups. In a multiple regression analysis, the global satisfaction (R(2) = .780) was positively and significantly correlated with CIS quality, confirmation of expectations and perceived CIS usefulness. The continuance intention (R(2) = .392) was positively and significantly correlated with perceived CIS usefulness, confirmation of expectations and global satisfaction. In a late post-adoption CIS deployment phase, continuance intention does not significantly depend on individual end user characteristics but is significantly associated with the perceived CIS usefulness, confirmation of expectations and global satisfaction.
Blaya, Joaquín A; Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F
To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p60 days to arrive (pChasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.
Paré, G; Sicotte, C; Jaana, M; Girouard, D
The aim of this study is to gain a better understanding of the risk factors influencing the success of clinical information system projects. This study addresses this issue by first reviewing the extant literature on information technology project risks, and second conducting a Delphi survey among 21 experts highly involved in clinical information system projects in Québec, Canada, a region where government have invested heavily in health information technologies in recent years. Twenty-three risk factors were identified. The absence of a project champion was the factor that experts felt most deserves their attention. Lack of commitment from upper management was ranked second. Our panel of experts also confirmed the importance of a variable that has been extensively studied in information systems, namely, perceived usefulness that ranked third. Respondents ranked project ambiguity fourth. The fifth-ranked risk was associated with poor alignment between the clinical information systems' characteristics and the organization of clinical work. The large majority of risk factors associated with the technology itself were considered less important. This finding supports the idea that technology-associated factors rarely figure among the main reasons for a project failure. In addition to providing a comprehensive list of risk factors and their relative importance, the study presents a major contribution by unifying the literature on information systems and medical informatics. Our checklist provides a basis for further research that may help practitioners identify the effective countermeasures for mitigating risks associated with the implementation of clinical information systems.
Lindsay, Gail M; Mior, Silvano A; Côté, Pierre; Carroll, Linda J; Shearer, Heather M
The purpose of this narrative inquiry was to explore the experiences of persons who were injured in traffic collisions and seek their recommendations for the development of clinical practice guideline (CPG) for the management of minor traffic injuries. Patients receiving care for traffic injuries were recruited from 4 clinics in Ontario, Canada resulting in 11 adult participants (5 men, 6 women). Eight were injured while driving cars, 1 was injured on a motorcycle, 2 were pedestrians, and none caused the collision. Using narrative inquiry methodology, initial interviews were audiotaped, and follow-up interviews were held within 2 weeks to extend the story of experience created from the first interview. Narrative plotlines across the 11 stories were identified, and a composite story inclusive of all recommendations was developed by the authors. The research findings and composite narrative were used to inform the CPG Expert Panel in the development of new CPGs. Four recommended directions were identified from the narrative inquiry process and applied. First, terminology that caused stigma was a concern. This resulted in modified language ("injured persons") being adopted by the Expert Panel, and a new nomenclature categorizing layers of injury was identified. Second, participants valued being engaged as partners with health care practitioners. This resulted in inclusion of shared decision-making as a foundational recommendation connecting CPGs and care planning. Third, emotional distress was recognized as a factor in recovery. Therefore, the importance of early detection and the ongoing evaluation of risk factors for delayed recovery were included in all CPGs. Fourth, participants shared that they were unfamiliar with the health care system and insurance industry before their accident. Thus, repeatedly orienting injured persons to the system was advised. A narrative inquiry of 11 patients' experiences with traffic collision and their recommendations for clinical
Tuti, Timothy; Bitok, Michael; Malla, Lucas; Paton, Chris; Muinga, Naomi; Gathara, David; Gachau, Susan; Mbevi, George; Nyachiro, Wycliffe; Ogero, Morris; Julius, Thomas; Irimu, Grace; English, Mike
In many low income countries health information systems are poorly equipped to provide detailed information on hospital care and outcomes. Information is thus rarely used to support practice improvement. We describe efforts to tackle this challenge and to foster learning concerning collection and use of information. This could improve hospital services in Kenya. We are developing a Clinical Information Network, a collaboration spanning 14 hospitals, policy makers and researchers with the goal of improving information available on the quality of inpatient paediatric care across common childhood illnesses in Kenya. Standardised data from hospitals' paediatric wards are collected using non-commercial and open source tools. We have implemented procedures for promoting data quality which are performed prior to a process of semi-automated analysis and routine report generation for hospitals in the network. In the first phase of the Clinical Information Network, we collected data on over 65 000 admission episodes. Despite clinicians' initial unfamiliarity with routine performance reporting, we found that, as an initial focus, both engaging with each hospital and providing them information helped improve the quality of data and therefore reports. The process has involved mutual learning and building of trust in the data and should provide the basis for collaborative efforts to improve care, to understand patient outcome, and to evaluate interventions through shared learning. We have found that hospitals are willing to support the development of a clinically focused but geographically dispersed Clinical Information Network in a low-income setting. Such networks show considerable promise as platforms for collaborative efforts to improve care, to provide better information for decision making, and to enable locally relevant research.
Sayyah Ensan, Ladan; Faghankhani, Masoomeh; Javanbakht, Anna; Ahmadi, Seyed-Foad; Baradaran, Hamid Reza
To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (PUpToDate compared to 29 min (95% CI: 26 to 32) using PubMed Clinical Queries (PUpToDate and also overall satisfaction were higher among UpToDate users compared to PubMed Clinical Queries users (PUpToDate compared to Pubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.
Ladan Sayyah Ensan
Full Text Available PURPOSE: To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. METHOD: A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. RESULTS: Based on intention-to-treat analysis, participants retrieved the answer of 67 (76% questions using UpToDate and 38 (43% questions using PubMed Clinical Queries (P<0.001. The median time to answer retrieval was 17 min (95% CI: 16 to 18 using UpToDate compared to 29 min (95% CI: 26 to 32 using PubMed Clinical Queries (P<0.001. The satisfaction with the accuracy of retrieved answers, interaction with UpToDate and also overall satisfaction were higher among UpToDate users compared to PubMed Clinical Queries users (P<0.001. CONCLUSIONS: For first time users, using UpToDate compared to Pubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.
Dal-Ré, Rafael; Carcas, Antonio J; Carné, Xavier; Wendler, David
Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low-risk pRCTs. The present study was designed to assess whether this view is specific to the US. The study took the form of a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives. A total of 2008 adults sampled from a probability-based online panel responded to the web-based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7-37.1%) than the alternative of verbal consent (12.7-14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent. The results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low-risk pRCTs. © 2017 The
Hines, Lisa E; Saverno, Kim R; Warholak, Terri L; Taylor, Ann; Grizzle, Amy J; Murphy, John E; Malone, Daniel C
Clinical decision support (CDS), such as drug-drug interaction (DDI) and drug-allergy checking, has been used in pharmacy information systems for several decades; however, there has been limited research on CDS use by practicing pharmacists. The purpose of this study was to document pharmacists' awareness of DDI and other medication-related CDS features available within pharmacy information systems. Researchers conducted on-site interviews with pharmacists throughout the state of Arizona from December 2008 to November 2009 regarding their pharmacy information systems features. Pharmacists were asked to provide information about DDI and other medication-related decision support features of the pharmacy software at their practice site. Descriptive statistics were used to summarize interview responses. Sixty-one pharmacists from a variety of practice settings completed the interview. All respondents indicated that their pharmacy system provided drug-allergy and DDI alerts. Approximately 60% of the pharmacists reported that their DDI decision support systems included recommendations for managing drug interactions. Two-thirds of respondents reported that their pharmacy's computer system permitted the addition of medications from other pharmacies and/or over-the-counter products to a patient's profile. Approximately 40% of the pharmacists reported that some drugs entered into the pharmacy computer system were not included in (or linked to) the electronic DDI checking. Most pharmacists indicated the presence of other medication-related decision support features, such as drug-disease (78%), drug-age precautions (67%), and inappropriate dosage alerts (79%). However, fewer pharmacists reported more advanced functionality, such as laboratory recommendations (34%) and pediatric dosing (39%). Overall, pharmacists' awareness regarding the many decision support functionalities of their systems was limited. Based on the study findings, it appears that there are a number of