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.
Jiang, Min; Wu, Yonghui; Shah, Anushi; Priyanka, Priyanka; Denny, Joshua C; Xu, Hua
Extraction of medication information embedded in clinical text is important for research using electronic health records (EHRs). However, most of current medication information extraction systems identify drug and signature entities without mapping them to standard representation. In this study, we introduced the open source Java implementation of MedEx, an existing high-performance medication information extraction system, based on the Unstructured Information Management Architecture (UIMA) framework. In addition, we developed new encoding modules in the MedEx-UIMA system, which mapped an extracted drug name/dose/form to both generalized and specific RxNorm concepts and translated drug frequency information to ISO standard. We processed 826 documents by both systems and verified that MedEx-UIMA and MedEx (the Python version) performed similarly by comparing both results. Using two manually annotated test sets that contained 300 drug entries from medication list and 300 drug entries from narrative reports, the MedEx-UIMA system achieved F-measures of 98.5% and 97.5% respectively for encoding drug names to corresponding RxNorm generic drug ingredients, and F-measures of 85.4% and 88.1% respectively for mapping drug names/dose/form to the most specific RxNorm concepts. It also achieved an F-measure of 90.4% for normalizing frequency information to ISO standard. The open source MedEx-UIMA system is freely available online at http://code.google.com/p/medex-uima/.
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
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
Teh, Ruth C; Wilson, Anne; Ranasinghe, Damith; Visvanathan, Renuka
To evaluate the health information technology (HIT) compared to Fall Risk for Older Persons (FROP) tool in fall risk screening. A HIT tool trial was conducted on the geriatric evaluation and management (GEM, n = 111) and acute medical units (AMU, n = 424). Health information technology and FROP scores were higher on GEM versus AMU, with no differences between people who fell and people who did not fall. Both score completion rates were similar, and their values correlated marginally (Spearman's correlation coefficient 0.33, P technology tool acceptability and scoring were comparable to FROP screening, with mixed effects on fall rate with HIT tool implementation. Clinician partnership remains key to effective tool development. © 2017 AJA Inc.
Duggan, Conor; Mason, Lauren; Banerjee, Penny; Milton, John
Assessing those with personality disorder for treatment in secure settings is known to be unsatisfactory. To examine the utility of a standardised assessment of offenders with personality disorder referred for treatment in secure care in a naturalistic study. A consecutive series of 89 men were assessed with a battery of four recommended instruments measuring personality and risk. Decisions on whether or not to admit were based on a multidisciplinary discussion informed by these assessments. Of the 89 comprehensively assessed referrals, 60 (67%) were offered admission. High scores on the Psychopathy Checklist-Revised (especially on Factor 1) was the only measure that was associated with rejection. Of 44 patients discharged, 29 (66%) failed to complete treatment; none of the pre-admission assessments distinguished ;completers' from ;non-completers'. Although skills were acquired on the unit, follow-up of 24 men in the community showed that this had only a marginal effect on re-offending rate (58%). Current recommended assessment methods appear unsatisfactory in identifying those who either (a) complete treatment or (b) benefit from treatment. Our results throw doubt on their value.
Noda, Emi; Mifune, Taka; Nakayama, Takeo
To characterize information on diabetes prevention appearing in Japanese general health magazines and to examine the agreement of the content with that in clinical practice guidelines for the treatment of diabetes in Japan. We used the Japanese magazines' databases provided by the Media Research Center and selected magazines with large print runs published in 2006. Two medical professionals independently conducted content analysis based on items in the diabetes prevention guidelines. The number of pages for each item and agreement with the information in the guidelines were determined. We found 63 issues of magazines amounting to 8,982 pages; 484 pages included diabetes prevention related content. For 23 items included in the diabetes prevention guidelines, overall agreement of information printed in the magazines with that in the guidelines was 64.5% (471 out of 730). The number of times these items were referred to in the magazines varied widely, from 247 times for food items to 0 times for items on screening for pregnancy-induced diabetes, dyslipidemia, and hypertension. Among the 20 items that were referred to at least once, 18 items showed more than 90% agreement with the guidelines. However, there was poor agreement for information on vegetable oil (2/14, 14%) and for specific foods (5/247, 2%). For the fatty acids category, "fat" was not mentioned in the guidelines; however, the term frequently appeared in magazines. "Uncertainty" was never mentioned in magazines for specific food items. The diabetes prevention related content in the health magazines differed from that defined in clinical practice guidelines. Most information in the magazines agreed with the guidelines, however some items were referred to inappropriately. To disseminate correct information to the public on diabetes prevention, health professionals and the media must collaborate.
Yohe, Sophia L; Carter, Alexis B; Pfeifer, John D; Crawford, James M; Cushman-Vokoun, Allison; Caughron, Samuel; Leonard, Debra G B
Next-generation sequencing performed in a clinical environment must meet clinical standards, which requires reproducibility of all aspects of the testing. Clinical-grade genomic databases (CGGDs) are required to classify a variant and to assist in the professional interpretation of clinical next-generation sequencing. Applying quality laboratory standards to the reference databases used for sequence-variant interpretation presents a new challenge for validation and curation. To define CGGD and the categories of information contained in CGGDs and to frame recommendations for the structure and use of these databases in clinical patient care. Members of the College of American Pathologists Personalized Health Care Committee reviewed the literature and existing state of genomic databases and developed a framework for guiding CGGD development in the future. Clinical-grade genomic databases may provide different types of information. This work group defined 3 layers of information in CGGDs: clinical genomic variant repositories, genomic medical data repositories, and genomic medicine evidence databases. The layers are differentiated by the types of genomic and medical information contained and the utility in assisting with clinical interpretation of genomic variants. Clinical-grade genomic databases must meet specific standards regarding submission, curation, and retrieval of data, as well as the maintenance of privacy and security. These organizing principles for CGGDs should serve as a foundation for future development of specific standards that support the use of such databases for patient care.
Aim of the study The technological progress that is currently being witnessed in the areas of diagnostic imaging, treatment planning systems and therapeutic equipment has caused radiotherapy to become a high-tech and interdisciplinary domain involving staff of various backgrounds. This allows steady improvement in therapy results, but at the same time makes the diagnostic, imaging and therapeutic processes more complex and complicated, requiring every stage of those processes to be planned, organized, controlled and improved so as to assure high quality of services provided. The aim of this paper is to present clinical quality standards for radiotherapy as developed by the author. Material and methods In order to develop the quality standards, a comparative analysis was performed between European and Polish legal acts adopted in the period of 1980-2006 and the universal industrial ISO 9001:2008 standard, defining requirements for quality management systems, and relevant articles published in 1984-2009 were reviewed, including applicable guidelines and recommendations of American, international, European and Polish bodies, such as the American Association of Physicists in Medicine (AAPM), the European Society for Radiotherapy & Oncology (ESTRO), the International Atomic Energy Agency (IAEA), and the Organisation of European Cancer Institutes (OECI) on quality assurance and management in radiotherapy. Results As a result, 352 quality standards for radiotherapy were developed and categorized into the following three groups: 1 – organizational standards; 2 – physico-technical standards and 3 – clinical standards. Conclusion Proposed clinical quality standards for radiotherapy can be used by any institution using ionizing radiation for medical purposes. However, standards are of value only if they are implemented, reviewed, audited and improved, and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:23788854
Miller, Franklin G
Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.
Zumsteg, Zachary S; Chen, Zinan; Howard, Lauren E; Amling, Christopher L; Aronson, William J; Cooperberg, Matthew R; Kane, Christopher J; Terris, Martha K; Spratt, Daniel E; Sandler, Howard M; Freedland, Stephen J
Prostate cancer is a heterogeneous disease, and risk stratification systems have been proposed to guide treatment decisions. However, significant heterogeneity remains for those with unfavorable-risk disease. This study included 3335 patients undergoing radical prostatectomy without adjuvant radiotherapy in the SEARCH database. High-risk patients were dichotomized into standard and very high-risk (VHR) groups based on primary Gleason pattern, percentage of positive biopsy cores (PPBC), number of NCCN high-risk factors, and stage T3b-T4 disease. Similarly, intermediate-risk prostate cancer was separated into favorable and unfavorable groups based on primary Gleason pattern, PPBC, and number of NCCN intermediate-risk factors. Median follow-up was 78 months. Patients with VHR prostate cancer had significantly worse PSA relapse-free survival (PSA-RFS, P < 0.001), distant metastasis (DM, P = 0.004), and prostate cancer-specific mortality (PCSM, P = 0.015) in comparison to standard high-risk (SHR) patients in multivariable analyses. By contrast, there was no significant difference in PSA-RFS, DM, or PCSM between SHR and unfavorable intermediate-risk (UIR) patients. Therefore, we propose a novel risk stratification system: Group 1 (low-risk), Group 2 (favorable intermediate-risk), Group 3 (UIR and SHR), and Group 4 (VHR). The c-index of this new grouping was 0.683 for PSA-RFS and 0.800 for metastases, compared to NCCN-risk groups which yield 0.666 for PSA-RFS and 0.764 for metastases. Patients classified as VHR have markedly increased rates of PSA relapse, DM, and PCSM in comparison to SHR patients, whereas UIR and SHR patients have similar prognosis. Novel therapeutic strategies are needed for patients with VHR, likely involving multimodality therapy. © 2017 Wiley Periodicals, Inc.
Lustenberger, Nadia A; Prodinger, Birgit; Dorjbal, Delgerjargal; Rubinelli, Sara; Schmitt, Klaus; Scheel-Sailer, Anke
To illustrate how routinely written narrative admission and discharge reports of a rehabilitation program for eight youths with chronic neurological health conditions can be transformed to the International Classification of Functioning, Disability and Health. First, a qualitative content analysis was conducted by building meaningful units with text segments assigned of the reports to the five elements of the Rehab-Cycle ® : goal; assessment; assignment; intervention; evaluation. Second, the meaningful units were then linked to the ICF using the refined ICF Linking Rules. With the first step of transformation, the emphasis of the narrative reports changed to a process oriented interdisciplinary layout, revealing three thematic blocks of goals: mobility, self-care, mental, and social functions. The linked 95 unique ICF codes could be grouped in clinically meaningful goal-centered ICF codes. Between the two independent linkers, the agreement rate was improved after complementing the rules with additional agreements. The ICF Linking Rules can be used to compile standardized health information from narrative reports if prior structured. The process requires time and expertise. To implement the ICF into common practice, the findings provide the starting point for reporting rehabilitation that builds upon existing practice and adheres to international standards. Implications for Rehabilitation This study provides evidence that routinely collected health information from rehabilitation practice can be transformed to the International Classification of Functioning, Disability and Health by using the "ICF Linking Rules", however, this requires time and expertise. The Rehab-Cycle ® , including assessments, assignments, goal setting, interventions and goal evaluation, serves as feasible framework for structuring this rehabilitation program and ensures that the complexity of local practice is appropriately reflected. The refined "ICF Linking Rules" lead to a standardized
Farmer, Lesley S. J.
ACRL and other academic librarians are currently re-examining the tough questions of learning, literacy, and education--and the librarians' role in addressing these issues. They can use AASL's learning standards as one springboard for thought, particularly in terms of articulating learning. The result is a developmentally appropriate set of…
... Health Professionals Questions to Ask about Your Treatment Research Informed Consent Credit: National Cancer Institute Informed consent is a ... of ensuring patient safety in research. During the informed consent process, the research team, which is made up of doctors and ...
Ohmann, C.; Canham, S.; Demotes, J.
The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were c...
Heravi, Bahareh Rahmanzadeh
This thesis was submitted for the degree of Doctor of Philosophy and awarded by Brunel University. Standards may be argued to be important enablers for achieving interoperability as they aim to provide unambiguous specifications for error-free exchange of documents and information. By implication, therefore, it is important to model and represent the concept of a standard in a clear, precise and unambiguous way. Although standards development organisations usually provide guidelines for th...
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...
Phelps, Sue F; Hyde, Loree; Planchon Wolf, Julie
The Association for College and Research Libraries published the Information Literacy Competency Standards for Nursing (ILCSN) in January 2014, written by a task force of the Health Sciences Interest Group of the American Library Association. The ILCSN describes skills ranging from basic to advanced information research competencies for students enrolled in nursing programs at all levels and for professional nurses. This article guides administrators and faculty in use of the standards to design programs and coursework in information skills to support evidence-based practice.
The Department of Energy (DOE), like other Federal agencies, is under increasing pressure to use information technology to improve efficiency in mission accomplishment as well as delivery of services to the public. Because users and systems have become interdependent, DOE has enterprise wide needs for common application architectures, communication networks, databases, security, and management capabilities. Users need open systems that provide interoperability of products and portability of people, data, and applications that are distributed throughout heterogeneous computing environments. The level of interoperability necessary requires the adoption of DOE wide standards, protocols, and best practices. The Department has developed an information architecture and a related standards adoption and retirement process to assist users in developing strategies and plans for acquiring information technology products and services based upon open systems standards that support application software interoperability, portability, and scalability. This set of Departmental Information Architecture standards represents guidance for achieving higher degrees of interoperability within the greater DOE community, business partners, and stakeholders. While these standards are not mandatory, particular and due consideration of their applications in contractual matters and use in technology implementations Department wide are goals of the Chief Information Officer.
Goss, Foster R; Zhou, Li; Plasek, Joseph M; Broverman, Carol; Robinson, George; Middleton, Blackford; Rocha, Roberto A
Allergy documentation and exchange are vital to ensuring patient safety. This study aims to analyze and compare various existing standard terminologies for representing allergy information. Five terminologies were identified, including the Systemized Nomenclature of Medical Clinical Terms (SNOMED CT), National Drug File-Reference Terminology (NDF-RT), Medication Dictionary for Regulatory Activities (MedDRA), Unique Ingredient Identifier (UNII), and RxNorm. A qualitative analysis was conducted to compare desirable characteristics of each terminology, including content coverage, concept orientation, formal definitions, multiple granularities, vocabulary structure, subset capability, and maintainability. A quantitative analysis was also performed to compare the content coverage of each terminology for (1) common food, drug, and environmental allergens and (2) descriptive concepts for common drug allergies, adverse reactions (AR), and no known allergies. Our qualitative results show that SNOMED CT fulfilled the greatest number of desirable characteristics, followed by NDF-RT, RxNorm, UNII, and MedDRA. Our quantitative results demonstrate that RxNorm had the highest concept coverage for representing drug allergens, followed by UNII, SNOMED CT, NDF-RT, and MedDRA. For food and environmental allergens, UNII demonstrated the highest concept coverage, followed by SNOMED CT. For representing descriptive allergy concepts and adverse reactions, SNOMED CT and NDF-RT showed the highest coverage. Only SNOMED CT was capable of representing unique concepts for encoding no known allergies. The proper terminology for encoding a patient's allergy is complex, as multiple elements need to be captured to form a fully structured clinical finding. Our results suggest that while gaps still exist, a combination of SNOMED CT and RxNorm can satisfy most criteria for encoding common allergies and provide sufficient content coverage.
Full Text Available One of the most serious bottlenecks in the scientific workflows of biodiversity sciences is the need to integrate data from different sources, software applications, and services for analysis, visualisation and publication. For more than a quarter of a century the TDWG Biodiversity Information Standards organisation has a central role in defining and promoting data standards and protocols supporting interoperability between disparate and locally distributed systems. Although often not sufficiently recognized, TDWG standards are the foundation of many popular Biodiversity Informatics applications and infrastructures ranging from small desktop software solutions to large scale international data networks. However, individual scientists and groups of collaborating scientist have difficulties in fully exploiting the potential of standards that are often notoriously complex, lack non-technical documentations, and use different representations and underlying technologies. In the last few years, a series of initiatives such as Scratchpads, the EDIT Platform for Cybertaxonomy, and biowikifarm have started to implement and set up virtual work platforms for biodiversity sciences which shield their users from the complexity of the underlying standards. Apart from being practical work-horses for numerous working processes related to biodiversity sciences, they can be seen as information brokers mediating information between multiple data standards and protocols. The ViBRANT project will further strengthen the flexibility and power of virtual biodiversity working platforms by building software interfaces between them, thus facilitating essential information flows needed for comprehensive data exchange, data indexing, web-publication, and versioning. This work will make an important contribution to the shaping of an international, interoperable, and user-oriented biodiversity information infrastructure.
Berendsohn, W G; Güntsch, A; Hoffmann, N; Kohlbecker, A; Luther, K; Müller, A
One of the most serious bottlenecks in the scientific workflows of biodiversity sciences is the need to integrate data from different sources, software applications, and services for analysis, visualisation and publication. For more than a quarter of a century the TDWG Biodiversity Information Standards organisation has a central role in defining and promoting data standards and protocols supporting interoperability between disparate and locally distributed systems.Although often not sufficiently recognized, TDWG standards are the foundation of many popular Biodiversity Informatics applications and infrastructures ranging from small desktop software solutions to large scale international data networks. However, individual scientists and groups of collaborating scientist have difficulties in fully exploiting the potential of standards that are often notoriously complex, lack non-technical documentations, and use different representations and underlying technologies. In the last few years, a series of initiatives such as Scratchpads, the EDIT Platform for Cybertaxonomy, and biowikifarm have started to implement and set up virtual work platforms for biodiversity sciences which shield their users from the complexity of the underlying standards. Apart from being practical work-horses for numerous working processes related to biodiversity sciences, they can be seen as information brokers mediating information between multiple data standards and protocols.The ViBRANT project will further strengthen the flexibility and power of virtual biodiversity working platforms by building software interfaces between them, thus facilitating essential information flows needed for comprehensive data exchange, data indexing, web-publication, and versioning. This work will make an important contribution to the shaping of an international, interoperable, and user-oriented biodiversity information infrastructure.
Sofarelli, Theresa A; Ricks, Jane H; Anand, Rahul; Hale, Devon C
International travel plays a significant role in the emergence and redistribution of major human diseases. The importance of travel medicine clinics for preventing morbidity and mortality has been increasingly appreciated, although few studies have thus far examined the management and staff training strategies that result in successful travel-clinic operations. Here, we describe an example of travel-clinic operation and management coordinated through the University of Utah School of Medicine, Division of Infectious Diseases. This program, which involves eight separate clinics distributed statewide, functions both to provide patient consult and care services, as well as medical provider training and continuing medical education (CME). Initial training, the use of standardized forms and protocols, routine chart reviews and monthly continuing education meetings are the distinguishing attributes of this program. An Infectious Disease team consisting of one medical doctor (MD) and a physician assistant (PA) act as consultants to travel nurses who comprise the majority of clinic staff. Eight clinics distributed throughout the state of Utah serve approximately 6,000 travelers a year. Pre-travel medical services are provided by 11 nurses, including 10 registered nurses (RNs) and 1 licensed practical nurse (LPN). This trained nursing staff receives continuing travel medical education and participate in the training of new providers. All nurses have completed a full training program and 7 of the 11 (64%) of clinic nursing staff serve more than 10 patients a week. Quality assurance measures show that approximately 0.5% of charts reviewed contain a vaccine or prescription error which require patient notification for correction. Using an initial training program, standardized patient intake forms, vaccine and prescription protocols, preprinted prescriptions, and regular CME, highly trained nurses at travel clinics are able to provide standardized pre-travel care to
Liu, Hu; Su, Rong-jia; Wu, Min-jie; Zhang, Yi; Qiu, Xiang-jun; Feng, Jian-gang; Xie, Ting; Lu, Shu-liang
To form a wound information management scheme with objectivity, standardization, and convenience by means of wound information management system. A wound information management system was set up with the acquisition terminal, the defined wound description, the data bank, and related softwares. The efficacy of this system was evaluated in clinical practice. The acquisition terminal was composed of the third generation mobile phone and the software. It was feasible to get access to the wound information, including description, image, and therapeutic plan from the data bank by mobile phone. During 4 months, a collection of a total of 232 wound treatment information was entered, and accordingly standardized data of 38 patients were formed automatically. This system can provide standardized wound information management by standardized techniques of acquisition, transmission, and storage of wound information. It can be used widely in hospitals, especially primary medical institutions. Data resource of the system makes it possible for epidemiological study with large sample size in future.
Schweiger, Ralf; Hölzer, Simon; Dudeck, Joachim
The bulk of clinical data is available in an electronic form. About 80% of the electronic data, however, is narrative text and therefore limited with respect to machine interpretation. As a result, the discussion has shifted from "electronic versus paper based data" towards "structured versus unstructured electronic data". The XML technology of today paves a way towards more structured clinical data and several XML based standards such as the Clinical Document Architecture (CDA) emerge. The implementation of XML based applications is yet a challenge. This paper will focus on XML retrieval issues and describe the difficulties and prospects of such an approach. The result of our work is a search technique called "topic matching" that exploits structured data in order to provide a search quality that is superior to established text matching methods. With this solution we are able to utilize large numbers of heterogeneously structured documents with only a minimum of effort.
Orel, Andrej; Bernik, Igor
Using widely spread common approaches to systems security in health dedicated controlled environments, a level of awareness, confidence and acceptance of relevant standardisation is evaluated. Patients' information is sensitive, so putting appropriate organisational techniques as well as modern technology in place to secure health information is of paramount importance. Mobile devices are becoming the top priorities in advanced information security planning with healthcare environments being no exception. There are less and less application areas in healthcare without having a need for a mobile functionality which represents an even greater information security challenge. This is also true in emergency treatments, rehabilitation and homecare just to mention a few areas outside hospital controlled environments. Unfortunately quite often traditional unsecured communications principles are still in routine use for communicating sensitive health related information. The security awareness level with users, patients and care professionals is not high enough so potential threats and risks may not be addressed and the respective information security management is therefore weak. Standards like ISO/IEC 27000 ISMS family, the ISO/IEC 27799 information security guidelines in health are often not well known, but together with legislation principles such as HIPAA, they can help.
M.L. Simoons (Maarten); N.H.J.J. van der Putten (Niek); D. Wood; J-P. Bassand (Jean-Pierre); H. Boersma (Eric)
textabstractThe building blocks come together, finally! Already three decades ago we were dreaming of the complete Cardiology Information System. However, at that time the computer programmers explained that it was too early. In the subsequent year information tech- nology (IT) specialists,
Han, Soon Hwa; Lee, Min Ho; Kim, Sang Guk; Jeong, Jun Yong; Lee, Bi Na; Choi, Myeong Seon; Kim, Il Kon; Park, Woo Sung; Ha, Kyooseob; Cho, Eunyoung; Kim, Yoon; Bae, Jae Bong
To develop effective ways of sharing patients' medical information, we developed a new medical information exchange system (MIES) based on a registry server, which enabled us to exchange different types of data generated by various systems. To assure that patient's medical information can be effectively exchanged under different system environments, we adopted the standardized data transfer methods and terminologies suggested by the Center for Interoperable Electronic Healthcare Record (CIEHR) of Korea in order to guarantee interoperability. Regarding information security, MIES followed the security guidelines suggested by the CIEHR of Korea. This study aimed to develop essential security systems for the implementation of online services, such as encryption of communication, server security, database security, protection against hacking, contents, and network security. The registry server managed information exchange as well as the registration information of the clinical document architecture (CDA) documents, and the CDA Transfer Server was used to locate and transmit the proper CDA document from the relevant repository. The CDA viewer showed the CDA documents via connection with the information systems of related hospitals. This research chooses transfer items and defines document standards that follow CDA standards, such that exchange of CDA documents between different systems became possible through ebXML. The proposed MIES was designed as an independent central registry server model in order to guarantee the essential security of patients' medical information.
Kim, Chang Soo [Dept. of Radiological Science, College of Health Science, Catholic University of Pusan, Pusan (Korea, Republic of)
Ubiquitous health care system, which is one of the developing solution technologies of IT, BT and NT, could give us new medical environments in future. Implementing health information systems can be complex, expensive and frustrating. Healthcare professionals seeking to acquire or upgrade systems do not have a convenient, reliable way of specifying a level of adherence to communication standards sufficient to achieve truly efficient interoperability. Great progress has been made in establishing such standards-DICOM, IHE and HL7, notably, are now highly advanced. IHE has defined a common framework to deliver the basic interoperability needed for local and regional health information networks. It has developed a foundational set of standards-based integration profiles for information exchange with three interrelated efforts. HL7 is one of several ANSI-accredited Standards Developing Organizations operating in the healthcare arena. Most SDOs produce standards (protocols) for a particular healthcare domain such as pharmacy, medical devices, imaging or insurance transactions. HL7's domain is clinical and administrative data. HL7 is an international community of healthcare subject matter experts and information scientists collaborating to create standards for the exchange, management and integration of electronic healthcare information. The ASTM specification for Continuity of Care Record was developed by subcommittee E31.28 on electronic health records, which includes clinicians, provider institutions, administrators, patient advocates, vendors, and health industry. In this paper, there are suggestions that provide a test bed, demonstration and specification of how standards such a IHE, HL7, ASTM can be used to provide an integrated environment.
... management: (1) Information system development, (2) Information collection, (3) Information handling and... 39 Postal Service 1 2010-07-01 2010-07-01 false Information security standards. 267.4 Section 267... INFORMATION § 267.4 Information security standards. (a) The Postal Service will operate under a uniform set of...
Carmichael, Mary-Ann; Bridge, Pete
The multifactorial nature of clinical skills development makes assessment of undergraduate radiation therapist competence level by clinical mentors challenging. A recent overhaul of the clinical assessment strategy at Queensland University of Technology has moved away from the high-stakes Objective Structured Clinical Examination (OSCE) to encompass a more continuous measure of competence. This quantitative study aimed to gather stakeholder evidence to inform development of standards by which to measure student competence for a range of levels of progression. A simple anonymous questionnaire was distributed to all Queensland radiation therapists. The tool asked respondents to assign different levels of competency with a range of clinical tasks to different levels of student. All data were anonymous and was combined for analysis using Microsoft Excel. Feedback indicated good agreement with tasks that specified the amount of direction required and this has been incorporated into the new clinical achievements record that the students need to have signed off. Additional puzzling findings suggested higher expectations with planning tasks than with treatment-based tasks. The findings suggest that the amount of direction required by students is a valid indicator of their level and has been adopted into the clinical assessment scheme. Further work will build on this to further define standards of competency for undergraduates.
Feb 17, 2004 ... unavoidable. The patient requests access to information about himself. / herself. In the past despite their curiosity patients would hardly ever have thought to ask their attending doctor for even a peek at his notes. But section 32 of the final Constitution of RSA states that “everyone has the right of access to.
Court, Jennifer H; Austin, Michael W
Virtual glaucoma clinics allow rapid, reliable patient assessment but the service should be acceptable to patients and concordance with treatment needs to be maintained with adequate patient education. This study compares experiences and understanding of patients reviewed via the virtual clinic versus the standard clinic by way of an extended patient satisfaction questionnaire (PSQ). One hundred PSQs were given to consecutive patients attending glaucoma clinics in October 2013. All 135 patients reviewed via the virtual clinic from April 2013 until August 2013 were sent postal PSQs in September 2013. Data were obtained for demographics, understanding of glaucoma, their condition, satisfaction with their experience, and quality of information. Responses were analyzed in conjunction with the clinical records. Eighty-five percent of clinic patients and 63% of virtual clinic patients responded to the PSQ. The mean satisfaction score was over 4.3/5 in all areas surveyed. Virtual clinic patients' understanding of their condition was very good, with 95% correctly identifying their diagnosis as glaucoma, 83% as ocular hypertension and 78% as suspects. There was no evidence to support inferior knowledge or self-perceived understanding compared to standard clinic patients. Follow-up patients knew more about glaucoma than new patients. Over 95% of patients found our information leaflet useful. Forty percent of patients sought additional information but less than 20% used the internet for this. A substantial proportion of glaucoma pathway patients may be seen by non-medical staff supervised by glaucoma specialists via virtual clinics. Patients are accepting of this format, reporting high levels of satisfaction and non-inferior knowledge to those seen in standard clinics.
Full Text Available Jennifer H Court,1 Michael W Austin1,21Department of Ophthalmology, Singleton Hospital, Swansea, Wales, UK; 2Department of Ophthalmology, Neath Port Talbot Hospital, Swansea, Wales, UKPurpose: Virtual glaucoma clinics allow rapid, reliable patient assessment but the service should be acceptable to patients and concordance with treatment needs to be maintained with adequate patient education. This study compares experiences and understanding of patients reviewed via the virtual clinic versus the standard clinic by way of an extended patient satisfaction questionnaire (PSQ.Patients and methods: One hundred PSQs were given to consecutive patients attending glaucoma clinics in October 2013. All 135 patients reviewed via the virtual clinic from April 2013 until August 2013 were sent postal PSQs in September 2013. Data were obtained for demographics, understanding of glaucoma, their condition, satisfaction with their experience, and quality of information. Responses were analyzed in conjunction with the clinical records.Results: Eighty-five percent of clinic patients and 63% of virtual clinic patients responded to the PSQ. The mean satisfaction score was over 4.3/5 in all areas surveyed. Virtual clinic patients’ understanding of their condition was very good, with 95% correctly identifying their diagnosis as glaucoma, 83% as ocular hypertension and 78% as suspects. There was no evidence to support inferior knowledge or self-perceived understanding compared to standard clinic patients. Follow-up patients knew more about glaucoma than new patients. Over 95% of patients found our information leaflet useful. Forty percent of patients sought additional information but less than 20% used the internet for this.Conclusion: A substantial proportion of glaucoma pathway patients may be seen by non-medical staff supervised by glaucoma specialists via virtual clinics. Patients are accepting of this format, reporting high levels of satisfaction and non
Gøeg, Kirstine Rosenbeck; Elberg, Pia Britt; Højen, Anne Randorff
Stakeholders in e-health such as governance officials, health IT-implementers and vendors have to co-operate to achieve the goal of a future-proof interoperable e-health infrastructure. Co-operation requires knowledge on the responsibility and competences of stakeholder groups. To increase awareness on clinical modeling and standardization we conducted a workshop for Danish and a few Norwegian e-health stakeholders' and made them discuss their views on different aspects of clinical modeling using a theoretical model as a point of departure. Based on the model, we traced stakeholders' experiences. Our results showed there was a tendency that stakeholders were more familiar with e-health requirements than with design methods, clinical information models and clinical terminology as they are described in the scientific literature. The workshop made it possible for stakeholders to discuss their roles and expectations to each other.
Sharma, Deepak K; Solbrig, Harold R; Prud'hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian
Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary's metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration.
... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Standards for safeguarding customer... OF CONGRESS STANDARDS FOR SAFEGUARDING CUSTOMER INFORMATION § 314.3 Standards for safeguarding customer information. (a) Information security program. You shall develop, implement, and maintain a...
Pediatric Chest Pain-Low-Probability Referral: A Multi-Institutional Analysis From Standardized Clinical Assessment and Management Plans (SCAMPs®), the Pediatric Health Information Systems Database, and the National Ambulatory Medical Care Survey.
Harahsheh, Ashraf S; O'Byrne, Michael L; Pastor, Bill; Graham, Dionne A; Fulton, David R
We conducted a study to assess test characteristics of red-flag criteria for identifying cardiac disease causing chest pain and technical charges of low-probability referrals. Accuracy of red-flag criteria was ascertained through study of chest pain Standardized Clinical Assessment and Management Plans (SCAMPs®) data. Patients were divided into 2 groups: Group1 (concerning clinical elements) and Group2 (without). We compared incidence of cardiac disease causing chest pain between these 2 groups. Technical charges of Group 2 were analyzed using the Pediatric Health Information System database. Potential savings for the US population was estimated using National Ambulatory Medical Care Survey data. Fifty-two percent of subjects formed Group 1. Cardiac disease causing chest pain was identified in 8/1656 (0.48%). No heart disease was identified in patients in Group 2 ( P = .03). Applying red-flags in determining need for referral identified patients with cardiac disease causing chest pain with 100% sensitivity. Median technical charges for Group 2, over a 4-year period, were US2014$775 559. Eliminating cardiac testing of low-probability referrals would save US2014$3 775 182 in technical charges annually. Red-flag criteria were an effective screen for children with chest pain. Eliminating cardiac testing in children without red-flags for referral has significant technical charge savings.
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.
Standardization plays an important role in library and information science (LIS), because it gives rules to identify, classify, access, select, exploit, communicate, exchange and preserve information. Standards are developed by national, European and international organizations. The objective of the study is to present the situation of standardization in library and information science in the countries that joined the European Union in 2004. The research covered Technical Committees that take the problems of LIS, their cooperation with European Committee for Standardization (CEN) and International Organization for Standardization (ISO). The second part of the study is an analysis of LIS standards published in the last 10 years. Data on published documents were gathered from online standards directories. The documents were searched using International Classification for Standards. Retrieved standards were analyzed for their origin and status. The research illustrates the changes in the national standardization, most popular topics and the growing importance of international cooperation in standardization.
... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing High Complexity Testing § 493.1457 Standard; Clinical consultant... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...
... Testing Laboratories Performing Moderate Complexity Testing § 493.1417 Standard; Clinical consultant qualifications. The clinical consultant must be qualified to consult with and render opinions to the laboratory's... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant qualifications. 493...
... Testing Laboratories Performing Moderate Complexity Testing § 493.1419 Standard; Clinical consultant... clinical consultation to the laboratory's clients; (b) Be available to assist the laboratory's clients in... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...
... Testing Laboratories Performing High Complexity Testing § 493.1455 Standard; Clinical consultant qualifications. The clinical consultant must be qualified to consult with and render opinions to the laboratory's... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant qualifications. 493...
NASA developed standards, which included the neutral body posture (NBP), to specify ways to design flight systems that support human health and safety. Nissan Motor Company, with US offices in Franklin, Tennessee, turned to NASA's NBP research for the development of a new driver's seat. The 2013 Altima now features the new seat, and the company plans to incorporate the seats in upcoming vehicles.
Pouchard, Line Catherine [ORNL; Poole, Stephen W [ORNL; Lothian, Josh [ORNL
This document explores sensor standards, sensor data models, and computer sensor software in order to determine the specifications and data representation best suited for analyzing and monitoring computer system health using embedded sensor data. We review IEEE 1451, OGC Sensor Model Language and Transducer Model Language (TML), lm-sensors and Intelligent Platform Management Inititative (IPMI).
Nguyen Xuan Thao
Full Text Available A rough fuzzy set is the result of the approximation of a fuzzy set with respect to a crisp approximation space. It is a mathematical tool for the knowledge discovery in the fuzzy information systems. In this paper, we introduce the concepts of rough standard neutrosophic sets and standard neutrosophic information system, and give some results of the knowledge discovery on standard neutrosophic information system based on rough standard neutrosophic sets.
U.S. Department of Health & Human Services — Examination of efficiency in health care requires that cost information be normalized. Medicare payments include both geographic and policy-based facility type...
Razvan Daniel ZOTA
Full Text Available Cloud computing represents one of the latest emerging trends in distributed computing that enables the existence of hardware infrastructure and software applications as services. The present paper offers a general approach to the cloud computing standardization as a mean of improving the speed of adoption for the cloud technologies. Moreover, this study tries to show out how organizations may achieve more consistent business processes while operating with cloud computing technologies.
Kuchinke, Wolfgang; Aerts, J; Semler, S C; Ohmann, C
Our objectives were to develop, based on the analysis of archived clinical trial documents and data and on the requirements of GCP-compliant electronic archiving, a concept for legally secure and technically feasible archiving of the entire clinical trial, including the essential documents of the trial master file and the study database. Based on own experiences with CDISC, existing implementations and future developments, CDISC standards were evaluated concerning requirements for archiving clinical studies. Trial master files of a small, medium and large clinical study were analyzed to collect specifications for electronic archiving of records. Two different ways of long-term storage exist for the clinical trial archive: document-oriented archival and data archiving of the study database. The trial master file has a highly complex structure; its different parts can vary greatly in size, depending of the working style of investigators, number of patients recruited, the number of adverse event reports and the number of queries. The CDISC standard ODM is especially suited for archiving clinical trials, because among other features it contains the entire clinical trial data and full audit trail information. On the other hand SDTM is a content standard suited for data warehouses. Two recent developments in CDISC will affect the archival of studies: the further development of ODM in the area of "eCRF submission" and the use of "Electronic Source Data". The complexity and size of the trial master file requires new solutions. Though ODM provides effective means to archive the study database, it shows still deficiencies, especially for the joint archiving of data and the complex documentation of the trial master file. A concept was developed in which the ODM standard is part of an integrated archiving of the trial data and documents. ODM archiving of the study database enables long-term storage which is GCP-compliant. Archiving of documents of the trial master file in PDF
Full Text Available Information security is one of the major challenges of the information and knowledge based society. The preoccupation of organizations to ensure the security of information in the digital environment has led to the emergence of specific standards in the field. Thus, ISO 27000 brings together reference standards in the field. Starting from ISO 27001, which summarizes policies and procedures on physical, legal and technological security risks, this paper looks at the steps the organization must undertake to implement the standards.
Schultz, James E.
Presents suggestions for developing algebraic concepts beginning in the early grades to develop a gradual building from informal to formal algebraic concepts that progresses over the K-12 curriculum. Includes suggestions for representing relationships, solving equations, employing meaningful applications of algebra, and using of technology. (MDH)
This virtual issue of the Health Information and Libraries Journal (HILJ) has been compiled to mark the 5th International Clinical Librarian Conference 2011. In considering the challenges of clinical information provision, the content selected for the virtual issue offers an international flavour of clinical information provision and covers a variety of different facets of clinical librarianship. The issue broadly covers the areas of information needs and preferences, clinical librarian roles and services, and education and training, and reflects the way in which a normal issue of the HILJ would be presented. This includes a review article, a collection of original articles, and the three regular features which comprise International Perspectives and Initiatives, Learning and Teaching in Action, and Using Evidence in Practice. All papers included in this virtual issue are available free online. © 2011 The authors. Health Information and Libraries Journal © 2011 Health Libraries Group.
This policy establishes a standard approach for managing information produced by, funded by, or received per regulated reporting and/or federal-wide requirements and subsequently held or cataloged in information management systems by EPA.
...-01] Announcing Approval of Federal Information Processing Standard 186-4, Digital Signature Standard.... SUMMARY: This notice announces the Secretary of Commerce's approval of Federal Information Processing... changes are effective on July 19, 2013. FOR FURTHER INFORMATION CONTACT: Elaine Barker (301) 975-2911...
Reid, Louise; O'Connor, Sandra; Richardson, Ita; Hogan, Jennifer; O'Donoghue, Theresa; Philip, Roy; Burke, Gerard
non-peer-reviewed Clinical staff must have access to high quality information in order to provide safe care to patients. This cannot be provided by clinical information systems (CIS) that are not correctly managed and regularly used. Ensuring the success of CIS in the healthcare environment presents a particular set of difficulties. This paper describes an action research study aimed at improving information success in a maternity hospital. Following a literature review and ...
Detwiller, Maureen; Petillion, Wendy
Moving a large healthcare organization from an old, nonstandardized clinical information system to a new user-friendly, standards-based system was much more than an upgrade to technology. This project to standardize terminology, optimize key processes, and implement a new clinical information system was a large change initiative over 4 years that affected clinicians across the organization. Effective change management and engagement of clinical stakeholders were critical to the success of the initiative. The focus of this article was to outline the strategies and methodologies used and the lessons learned.
Lee, Jinhyung; Park, Young-Taek
The objective of this study was to create a new measure for clinical information technology (IT) adoption as a proxy variable of clinical IT use. Healthcare Information and Management Systems Society (HIMSS) data for 2004 were used. The 18 clinical IT applications were analyzed across 3,637 acute care hospitals in the United States. After factor analysis was conducted, the clinical IT adoption score was created and evaluated. Basic clinical IT systems, such as laboratory, order communication/results, pharmacy, radiology, and surgery information systems had different adoption patterns from advanced IT systems, such as cardiology, radio picture archiving, and communication, as well as computerized practitioner order-entry. This clinical IT score varied across hospital characteristics. Different IT applications have different adoption patterns. In creating a measure of IT use among various IT components in hospitals, the characteristics of each type of system should be reflected. Aggregated IT adoption should be used to explain technology acquisition and utilization in hospitals.
Benjamin R. Harris
The publication of educational standards inspires a variety of responses---from wholesale acceptance and deployment to criticism and blame. The author of this paper contends that the revision of the ACRL’s Information Literacy Competency Standards for Higher Education must be accompanied by a critical, conscious, and conscientious reception by librarians and information literacy advocates.
Benjamin R. Harris
Full Text Available The publication of educational standards inspires a variety of responses---from wholesale acceptance and deployment to criticism and blame. The author of this paper contends that the revision of the ACRL’s Information Literacy Competency Standards for Higher Education must be accompanied by a critical, conscious, and conscientious reception by librarians and information literacy advocates.
... 45 Public Welfare 1 2010-10-01 2010-10-01 false Standards for health information technology to... Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES HEALTH INFORMATION TECHNOLOGY HEALTH INFORMATION... FOR HEALTH INFORMATION TECHNOLOGY Standards and Implementation Specifications for Health Information...
Sun, Weiyi; Rumshisky, Anna; Uzuner, Ozlem
Temporal information in clinical narratives plays an important role in patients' diagnosis, treatment and prognosis. In order to represent narrative information accurately, medical natural language processing (MLP) systems need to correctly identify and interpret temporal information. To promote research in this area, the Informatics for Integrating Biology and the Bedside (i2b2) project developed a temporally annotated corpus of clinical narratives. This corpus contains 310 de-identified discharge summaries, with annotations of clinical events, temporal expressions and temporal relations. This paper describes the process followed for the development of this corpus and discusses annotation guideline development, annotation methodology, and corpus quality. Copyright © 2013 Elsevier Inc. All rights reserved.
Yin, Liang; Shi, Li-Chen; Zhao, Jun-Yan; Du, Song-Yang; Xie, Wen-Bo; Yuan, Fei; Chen, Duan-Bing
Entity information network is used to describe structural relationships between entities. Taking advantage of its extension and heterogeneity, entity information network is more and more widely applied to relationship modeling. Recent years, lots of researches about entity information network modeling have been proposed, while seldom of them concentrate on equipment-standard system with properties of multi-layer, multi-dimension and multi-scale. In order to efficiently deal with some complex issues in equipment-standard system such as standard revising, standard controlling, and production designing, a heterogeneous information network model for equipment-standard system is proposed in this paper. Three types of entities and six types of relationships are considered in the proposed model. Correspondingly, several different similarity-measuring methods are used in the modeling process. The experiments show that the heterogeneous information network model established in this paper can reflect relationships between entities accurately. Meanwhile, the modeling process has a good performance on time consumption.
Cariello, Angelino; Viana, Giovanni André; Osaki, Midori; Pamplona, André Luis; Höfling-Lima, Ana Luisa
Medical photographic documentation is important for professional, research, and ethical concerns. This study analyzed the possible interference that the flash could cause on evaluation of lower eyelid cosmetic results. Standardized photographs with and without flash were taken of 10 patients with dermatochalasis. The photographs were evaluated by 3 independent observers, as before (without flash) and after (with flash) an alternative esthetic treatment of the lower eyelid. The observers rated the overall cosmetic improvement of the lower eyelid photographs on a visual analog scale. The 3 surgeons believed that there was improvement in cosmetic outcome from the first (without flash) to the second (with flash) picture. The results indicate that a simple flash addition in one of 2 consecutive photographs, taken seconds apart, could influence the impression of experienced surgeons on the final outcome of oculoplastic surgeries and may constitute a bias in observer-dependent studies.
The purpose of this Service Action Plan is to announce, as well as provide, a high-level outline of a new Departmental process for the adoption and retirement of information technology standards. This process supports the implementation of a Department of Energy (DOE) Information Architecture. This plan was prepared with the Department of Energy information technology standards customers and stakeholders in mind. The process described in this plan will be serviced primarily by staff from the Office of the Deputy Assistant Secretary for Information Management with assistance from designated program and site Information Technology Standards Points of Contact. We welcome any comments regarding this new Departmental process and encourage the proposal of information technology standards for adoption or retirement.
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 ...
Open Architecture, Standards and Information Systems (OASIS) for Healthcare in Africa. This project will help African countries develop and maintain low-cost sustainable health information systems, and use the information systems to address health issues at both the facility and the public health level. It will do so by ...
Slone, B.J. III; Richardson, C.E.
In December 1986, the International Organization for Standardization (SO) issued a standard for document representation, ISO 8879, open-quotes Standard Generalized Markup Languageclose quotes (SGML). The standard prescribes a method for defining documents in two parts, one containing text and the other describing its structure without reference to word processing or publishing system software or hardware. It provides a method for open-quotes marking upclose quotes information, a way to place open-quotes tagsclose quotes on pieces of information to define their purpose. The SGML is part of a group of ISO standards titled open-quotes Information Processing-Text and Office Systems.close quotes This group contains the Document Style Specification and Semantics Language, the Standard Document Interchange Format, the Standard Page Description Language, and the fonts standard. The Department of Defense (DoD) has taken a standards initiative to improve the efficiency and reliability of systems by mandating that DoD suppliers comply with specific standards when delivering technical information. The initiative is called the Computer-aided Acquisition and Logistics Support (CALS) and includes a package of standards to address engineering drawings, raster font images, vector illustrations, text, and magnetic tape format. SGML is the CALS standard for documentation representation. Other industries have adopted this standard. Several industry groups, such as the Air Transport Association, American Association of Publishers, and the Telecommunications Industry Forum, are moving ahead vigorously with their own applications of SGML. The Institute of Electrical and Electronics Engineers has also adopted the ISO standard for production of its documents. Work is under way to develop their own SGML application
Jenders, Robert A; Jenders, Robert Allen; Del Fiol, Guilherme; Kawamoto, Kensaku; Sailors, R Matthew
Health Level Seven (HL7) has evolved into an international standards development organization (SDO) with a suite of standards. Prominent among these are formalisms related to clinical decision support, including the Arden Syntax, GELLO and Decision Support Service (DSS) standards. Continuing improvement in these standards and ongoing development of future decision support standards require wide participation in order to maximize their success. Accordingly, the purpose of the workshop is twofold. First, instructors will convey the latest developments regarding existing decision support standards and related efforts to develop new standards. Second, the instructors will solicit feedback so that attendees who do not participate in HL7 can have input into the standards activities of that organization. The instructors of this workshop, who are the co-chairs and/or members of the Clinical Decision Support Technical Committee of HL7, will review progress in these areas. They will present the details of the ongoing development of the extant Arden Syntax, GELLO and DSS standards. They will discuss work on current draft and proposed future standards, including the Infobutton communication and Order Set standards that are undergoing development in anticipation of certification as standards. Finally, they will solicit discussion regarding the future direction of standards development in these areas.
Feblowitz, Joshua C; Wright, Adam; Singh, Hardeep; Samal, Lipika; Sittig, Dean F
To provide high-quality and safe care, clinicians must be able to optimally collect, distill, and interpret patient information. Despite advances in text summarization, only limited research exists on clinical summarization, the complex and heterogeneous process of gathering, organizing and presenting patient data in various forms. To develop a conceptual model for describing and understanding clinical summarization in both computer-independent and computer-supported clinical tasks. Based on extensive literature review and clinical input, we developed a conceptual model of clinical summarization to lay the foundation for future research on clinician workflow and automated summarization using electronic health records (EHRs). Our model identifies five distinct stages of clinical summarization: (1) Aggregation, (2) Organization, (3) Reduction and/or Transformation, (4) Interpretation and (5) Synthesis (AORTIS). The AORTIS model describes the creation of complex, task-specific clinical summaries and provides a framework for clinical workflow analysis and directed research on test results review, clinical documentation and medical decision-making. We describe a hypothetical case study to illustrate the application of this model in the primary care setting. Both practicing physicians and clinical informaticians need a structured method of developing, studying and evaluating clinical summaries in support of a wide range of clinical tasks. Our proposed model of clinical summarization provides a potential pathway to advance knowledge in this area and highlights directions for further research. Copyright © 2011 Elsevier Inc. All rights reserved.
This report presents preliminary safety information for the standard MHTGR. Topics discussed include: plant protection, instrumentation, and control; electrical systems; service systems; and steam and energy conversion systems. (JDB)
Full Text Available This paper presets results from a review of the current standards used for collaboration between economic information systems, including web services and service oriented architecture, EDI, ebXML framework, RosettaNet framework, cXML, xCBL UBL, BPMN, BPEL, WS-CDL, ASN.1, and others. Standards have a key role in promoting economic information system interoperability, and thus enable collaboration. Analyzing the current standards, technologies and applications used for economic information systems interoperability has revealed a common pattern that runs through all of them. From this pattern we construct a basic model of interoperability around which we relate and judge all standards, technologies and applications for economic information systems interoperability.
Harris, Benjamin R.
The publication of educational standards inspires a variety of responses, from wholesale acceptance and deployment to criticism and blame. The author of this paper contends that the revision of the ACRL's "Information Literacy Competency Standards for Higher Education" must be accompanied by a critical, conscious, and conscientious…
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document contains Illinois Occupational Skill Standards for occupations in the Information Technology Design and Build Cluster (technical writer, programmer, system analyst, network architect, application product architect, network engineer, and database administrator). The skill standards define what an individual should know and the…
... standards ``nearly irrelevant.'' The comment contended that today's businesses are involved in several NAICS... SMALL BUSINESS ADMINISTRATION 13 CFR Part 121 RIN 3245-AG26 Small Business Size Standards: Information AGENCY: U.S. Small Business Administration. ACTION: Final rule. SUMMARY: The United States Small...
Phelps, Sue F
This column documents the rationale for creating information literacy competency standards for nursing based on the Association of College and Research Libraries (ACRL) "Information Literacy Competency Standards for Higher Education" and the three documents from the American Association of Colleges of Nursing (AACN) on essential skills for nurses in baccalaureate, masters, and doctoral level education and practice. It chronicles the process of the task force which is designing the discipline specific skills and predicts the value of their use, once they are published.
Caon, Martin [School of Nursing and Midwifery, Flinders University, Adelaide (Australia)], E-mail: firstname.lastname@example.org
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)
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)
Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice
Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.
Bogusz-Czerniewicz, Marta; Kaźmierczak, Daniel
Background Indisputably, radiotherapy has become an entirely interdisciplinary specialty. This situation requires efficient planning, verification, monitoring, quality control and constant improvement of all aspects of service delivery, referring both to patients’ (including diagnosis, prescription and method of treatment, its justification, realization and follow up) and organizational, technical and physics matters. Aim The aim of this work was to develop technical, physics and clinical quality standards for radiotherapy. This paper presents chosen standards for each of the aforementioned category. Materials and methods For the development of quality standards the comparison analysis of EU and Polish acts of law passed between 1980 and 2010 was conducted, the universal industrial ISO norm 9001:2008 referring to quality management system was reviewed. Recommendations of this norm were completed with detailed quality standards based on the author's 11 year work experience and the review of articles on quality assurance and quality control standards for radiotherapy published between 1984 and 2009 and the review of current recommendations and guidelines of American, International, European and National bodies (associations, societies, agencies such as AAPM, ESTRO, IAEA, and OECI) for quality assurance and quality management in radiotherapy. Results As a result 352 quality standards for radiotherapy were developed and categorized into the following three groups: (1) organizational standards, (2) physics and technical standards and (3) clinical standards. Conclusions Proposed quality standards for radiotherapy, can be used by any institution using ionizing radiation for medical procedures. Nevertheless standards are only of value if they are implemented, reviewed, audited and improved and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:24377023
We, the Architectural and Transportation Barriers Compliance Board (Access Board or Board), are revising and updating, in a single rulemaking, our standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. The revisions and updates to the section 508-based standards and section 255-based guidelines are intended to ensure that information and communication technology covered by the respective statutes is accessible to and usable by individuals with disabilities.
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
application portability, znd information about how to tailor procurement specifications to avoid potability problems. The standards arena is broad and is...Facs~mile Apprrout (Adopts MTA 538-19U) 1500893 (Approved) I GPC NIST Wntial Geapitics Eau =& sepecification TOGES) (adopts FF5 PUB Iaforroatioaal... Potable Operating Systen Interface (POSIX) -Pant I: 1003. 1b:1993 Informational System Application Progism Interface (API) Amendment (Approved) _ _1
Prodinger, Birgit; Tennant, Alan; Stucki, Gerold
In clinical practice and research a variety of clinical data collection tools are used to collect information on people's functioning for clinical practice and research and national health information systems. Reporting on ICF-based common metrics enables standardized documentation of functioning information in national health information systems. The objective of this methodological note on applying the ICF in rehabilitation is to demonstrate how to report functioning information collected with a data collection tool on ICF-based common metrics. We first specify the requirements for the standardized reporting of functioning information. Secondly, we introduce the methods needed for transforming functioning data to ICF-based common metrics. Finally, we provide an example. The requirements for standardized reporting are as follows: 1) having a common conceptual framework to enable content comparability between any health information; and 2) a measurement framework so that scores between two or more clinical data collection tools can be directly compared. The methods needed to achieve these requirements are the ICF Linking Rules and the Rasch measurement model. Using data collected incorporating the 36-item Short Form Health Survey (SF-36), the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), and the Stroke Impact Scale 3.0 (SIS 3.0), the application of the standardized reporting based on common metrics is demonstrated. A subset of items from the three tools linked to common chapters of the ICF (d4 Mobility, d5 Self-care and d6 Domestic life), were entered as "super items" into the Rasch model. Good fit was achieved with no residual local dependency and a unidimensional metric. A transformation table allows for comparison between scales, and between a scale and the reporting common metric. Being able to report functioning information collected with commonly used clinical data collection tools with ICF-based common metrics enables clinicians
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.
Kahn, Charles E; Langlotz, Curtis P; Channin, David S; Rubin, Daniel L
The Digital Imaging and Communications in Medicine (DICOM) Standard is a key foundational technology for radiology. However, its complexity creates challenges for information system developers because the current DICOM specification requires human interpretation and is subject to nonstandard implementation. To address this problem, a formally sound and computationally accessible information model of the DICOM Standard was created. The DICOM Standard was modeled as an ontology, a machine-accessible and human-interpretable representation that may be viewed and manipulated by information-modeling tools. The DICOM Ontology includes a real-world model and a DICOM entity model. The real-world model describes patients, studies, images, and other features of medical imaging. The DICOM entity model describes connections between real-world entities and the classes that model the corresponding DICOM information entities. The DICOM Ontology was created to support the Cancer Biomedical Informatics Grid (caBIG) initiative, and it may be extended to encompass the entire DICOM Standard and serve as a foundation of medical imaging systems for research and patient care. RSNA, 2010
American Chemical Society, Washington, DC.
Practical information on how to implement a chemical-related safety program is outlined in this publication. Highlights of the federal Occupational Safety and Health Administrations (OSHA) Hazard Communication Standard are presented and explained. These include: (1) hazard communication requirements (consisting of warning labels, material safety…
Open Architecture Standards and Information Systems (OASIS II) - Developing Capacity, Sharing Knowledge and Good Principles Across eHealth in Africa. Health care across much of the African continent is hampered by meager resources and a growing burden of disease, with HIV/AIDS, tuberculosis (TB) and malaria ...
Bates, Marcia J
In order to be effective for their users, information retrieval (IR) systems should be adapted to the specific needs of particular environments. The huge and growing array of types of information retrieval systems in use today is on display in Understanding Information Retrieval Systems: Management, Types, and Standards, which addresses over 20 types of IR systems. These various system types, in turn, present both technical and management challenges, which are also addressed in this volume. In order to be interoperable in a networked environment, IR systems must be able to use various types of
de Carvalho, Elias Cesar Araujo; Jayanti, Madhav Kishore; Batilana, Adelia Portero; Kozan, Andreia M O; Rodrigues, Maria J; Shah, Jatin; Loures, Marco R; Patil, Sunita; Payne, Philip; Pietrobon, Ricardo
With the globalization of clinical trials, a growing emphasis has been placed on the standardization of the workflow in order to ensure the reproducibility and reliability of the overall trial. Despite the importance of workflow evaluation, to our knowledge no previous studies have attempted to adapt existing modeling languages to standardize the representation of clinical trials. Unified Modeling Language (UML) is a computational language that can be used to model operational workflow, and a UML profile can be developed to standardize UML models within a given domain. This paper's objective is to develop a UML profile to extend the UML Activity Diagram schema into the clinical trials domain, defining a standard representation for clinical trial workflow diagrams in UML. Two Brazilian clinical trial sites in rheumatology and oncology were examined to model their workflow and collect time-motion data. UML modeling was conducted in Eclipse, and a UML profile was developed to incorporate information used in discrete event simulation software. Ethnographic observation revealed bottlenecks in workflow: these included tasks requiring full commitment of CRCs, transferring notes from paper to computers, deviations from standard operating procedures, and conflicts between different IT systems. Time-motion analysis revealed that nurses' activities took up the most time in the workflow and contained a high frequency of shorter duration activities. Administrative assistants performed more activities near the beginning and end of the workflow. Overall, clinical trial tasks had a greater frequency than clinic routines or other general activities. This paper describes a method for modeling clinical trial workflow in UML and standardizing these workflow diagrams through a UML profile. In the increasingly global environment of clinical trials, the standardization of workflow modeling is a necessary precursor to conducting a comparative analysis of international clinical trials
LeFebvre, Kristine B; Felice, Toni L
As the use of oral chemotherapy continues to rise, new approaches are needed to ensure patient safety. To help address this issue, the American Society of Clinical Oncology/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards were expanded in 2013 to include additional measures addressing oral anticancer drugs (OACs). Because minimal data assessing the application of these standards exist, ONS conducted an independent survey of oncology nurses to evaluate the application of these standards in practice as they relate to several areas of OAC use: assessment, consent, patient education, drug verification, and monitoring. The data revealed that, although the standards are followed in many settings, a large number of settings do not have processes in place to support safety standards and ensure patient safety when administering OACs. Information gained in this informal survey can be used to guide additional research and educational initiatives.
In 2004 a new work item proposal (NWIP) was accepted by the International Organization for Standardization (ISO) Technical Committee 85 (TC85 -- Nuclear Energy), Subcommittee 2 (Radiation Protection) for the development of a standard for the clinical dosimetry of beta radiation sources used for brachytherapy. To develop this standard, a new Working Group (WG 22 - Ionizing Radiation Dosimetry and Protocols in Medical Applications) was formed. The standard is based on the work of an ad-hoc working group initiated by the Dosimetry task group of the Deutsches Insitiut für Normung (DIN). Initially the work was geared mainly towards the needs of intravascular brachytherapy, but with the decline of this application, more focus has been placed on the challenges of accurate dosimetry for the concave eye plaques used to treat ocular melanoma. Guidance is given for dosimetry formalisms, reference data to be used, calibrations, measurement methods, modeling, uncertainty determinations, treatment planning and reporting, and clinical quality control. The document is currently undergoing review by the ISO member bodies for acceptance as a Committee Draft (CD) with publication of the final standard expected by 2007. There are opportunities for other ISO standards for medical dosimetry within the framework of WG22.
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 institutional review boards 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. © The Author(s) 2015.
Recognition of the improvements in patient safety, quality of patient care, and efficiency that health care information systems have the potential to bring has led to significant investment. Globally the sale of health care information systems now represents a multibillion dollar industry. As policy makers, health care professionals, and patients, we have a responsibility to maximize the return on this investment. To this end we analyze alternative licensing and software development models, as well as the role of standards. We describe how licensing affects development. We argue for the superiority of open source licensing to promote safer, more effective health care information systems. We claim that open source licensing in health care information systems is essential to rational procurement strategy. PMID:21447469
Gerdsen, F; Müller, S; Jablonski, S; Prokosch, H-U
The exchange of medical data from research and clinical routine across institutional borders is essential to establish an integrated healthcare platform. In this project we want to realize the standardized exchange of medical data between different healthcare institutions to implement an integrated and interoperable information system supporting clinical treatment and research of glaucoma. The central point of our concept is a standardized communication model based on the Clinical Document Architecture (CDA). Further, a communication concept between different health care institutions applying the developed document model has been defined. With our project we have been able to prove that standardized communication between an Electronic Medical Record (EMR), an Electronic Health Record (EHR) and the Erlanger Glaucoma Register (EGR) based on the established conceptual models, which rely on CDA rel.1 level 1 and SCIPHOX, could be implemented. The HL7-tool-based deduction of a suitable CDA rel.2 compliant schema showed significant differences when compared with the manually created schema. Finally fundamental requirements, which have to be implemented for an integrated health care platform, have been identified. An interoperable information system can enhance both clinical treatment and research projects. By automatically transferring screening findings from a glaucoma research project to the electronic medical record of our ophthalmology clinic, clinicians could benefit from the availability of a longitudinal patient record. The CDA as a standard for exchanging clinical documents has demonstrated its potential to enhance interoperability within a future shared care paradigm.
Gazzarata, Roberta; Vergari, Fabio; Cinotti, Tullio Salmon; Giacomini, Mauro
Care of chronic cardiac patients requires information interchange between patients' homes, clinical environments, and the electronic health record. Standards are emerging to support clinical information collection, exchange and management and to overcome information fragmentation and actors delocalization. Heterogeneity of information sources at patients' homes calls for open solutions to collect and accommodate multidomain information, including environmental data. Based on the experience gained in a European Research Program, this paper presents an integrated and open approach for clinical data interchange in cardiac telemonitoring applications. This interchange is supported by the use of standards following the indications provided by the national authorities of the countries involved. Taking into account the requirements provided by the medical staff involved in the project, the authors designed and implemented a prototypal middleware, based on a service-oriented architecture approach, to give a structured and robust tool to congestive heart failure patients for their personalized telemonitoring. The middleware is represented by a health record management service, whose interface is compliant to the healthcare services specification project Retrieve, Locate and Update Service standard (Level 0), which allows communication between the agents involved through the exchange of Clinical Document Architecture Release 2 documents. Three performance tests were carried out and showed that the prototype completely fulfilled all requirements indicated by the medical staff; however, certain aspects, such as authentication, security and scalability, should be deeply analyzed within a future engineering phase.
Full Text Available It is widely agreed that standards provide numerous benefits when available and enforced. Company-internal Information Systems (IS management procedures and solutions, in the following coined IS ‘standards’, allow for harmonizing operations between company units, locations and even different service providers. However, many companies lack an organized process for defining and managing internal IS standards, which causes uncertainties and delays in decision making, planning, and design processes. In this case study of the globally operating InduMaker (anonymized company name, an established manufacturing supplier, we look into the company-internal management of IS standards. Theoretically grounded in the organizational and IS-focused literature on business process modelling and business process commoditization, we describe and investigate InduMaker’s newly developed Standard Management Process (SMP for defining and managing company-internal business and IS standards, with which the multinational pursues offering clear answers to business and IT departments about existing IS standards, their degree of obligation, applicability, and scope at any time.
Full Text Available The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
Men'shikov, V V
The generalized data concerning the conditions of application of regulations of national standards in clinical diagnostic laboratories of medical organizations is presented. The primary information was provided by 14 regions of 6 federal administrative okrugs of Russia. The causes of challenges of application of requirements of standards are presented. They are mostly related with insufficient financial support, lacking of manpower, difficulties with reagents supply, inadequate technical maintenance of devices and absence of support of administration of medical organizations. The recommendations are formulated concerning the necessity of publishing the document of Minzdrav of Russia to determine the need in application of standards in laboratory practice.
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
Scholz, Joachim; Rathmell, James P; David, William S; Chad, David A; Broderick, Alithia C; Perros, Stephen G; Shin, Naomi S; Wells, Jenna L; Davis, John B; DiMaggio, Charles J; Wang, Shuang; Tate, Simon N
Diabetic polyneuropathy (DPN) is a major cause of neuropathic pain and a frequent target condition in analgesic treatment trials. Differences in the clinical symptoms and signs associated with DPN suggest distinct pathophysiological mechanisms underlying nerve damage and dysfunction that are likely to have therapeutic relevance. The aim of this study was to develop a tool for the bedside assessment of painful neuropathies such as DPN that captures the diversity of phenotypes. Sixty-one patients with type 2 diabetes and painful neuropathy, 19 patients with painless DPN, 25 patients with type 2 diabetes but no clinical evidence of neuropathy, and 20 healthy control subjects completed a structured interview (47 items) and a standardized physical examination (39 items). After analyzing critical features of pain and painless symptoms and examining the outcome of physical tests of sensory function, we determined principal components of the phenotypic variance among patients. Increased sensitivity to mechanical or thermal stimuli and, to a lesser extent, the sensory quality of pain or paresthesia were the most discriminating elements of DPN phenotypes. Correlation patterns of symptoms and signs indicated the involvement of functionally distinct nerve fiber populations. We combined interview questions and physical tests identifying these differences in a shortened assessment protocol that we named Standardized Evaluation of Pain and Somatosensory Function (StEPS). The protocol StEPS generates a phenotypic profile of patients with neuropathy. Separate intensity ratings for spontaneous painful symptoms and pain evoked by standard stimuli support a detailed documentation of neuropathic pain and its response to analgesic treatment.
Perkins, Joanne; Aguado-Lorenzo, Virginia; Arenas-Lopez, Sara
The use of standard concentrations of intravenous infusions has been advocated by international organisations to increase intravenous medication safety in paediatric and neonatal critical care. However, there is no guidance on how to identify and implement these infusions leading to great interunit variability. To identify the most appropriate clinical concentrations required by our paediatric intensive care unit (PICU) population with regard to accuracy of delivery and overall fluid allowance. Firstly a matrix was used to balance the concentration, dose and infusion volume (weight range 1.5-50 kg). Results were further refined considering: patient fluid allowance based on fluid volume targets, infusion pump accuracy and challenging each infusion against clinical scenarios requiring administration of multiple drug infusions found in PICU. Consideration was given to the standard concentrations routinely used in adults, in order to assess whether alignment with paediatrics was possible for some of the concentrations proposed. Finally a risk assessment of the infusions was conducted using the NPSA 20 tool. Twenty-five drugs identified as the most commonly used intravenous infusions in the unit. For the majority of the medicines, three weight bands of standard concentrations were necessary to cover the children's weight ranges and kept within predefined fluid requirements and accuracy of delivery. This work shows a patient focused systematic approach for defining and evaluating standardised concentrations in intensive care children. © 2016 Royal Pharmaceutical Society.
Carpenter, M.; Fair, M.E.; Lalonde, P.; Scott, T.
A new recommended guideline for the standard data collection of individual identifying information has been developed and tested by Statistics Canada. The purpose of developing a standard method is to improve health record keeping in Canada: in particular for long term medical follow-up studies of individuals exposed to potentially hazardous agents for detection of possible health risks or delayed harm, e.g. individuals exposed to radiation through occupations, the environment, emergencies, or therapeutic practice. A data collection standard is also useful for epidemiological follow-up studies for other occupation groups such as chemical workers and miners, or for lifestyle, genetic and other studies. Statistics Canada, Health Division, Occupational and Environmental Health Research Unit (OEHRU), from their experience with long term health studies using the Canadian Mortality Data Base, has prepared a 'Data Collection Package' to include the developed and tested data collection guideline. It is anticipated this will help produce more thorough and comparable on-going record keeping while saving costs and time for many organizations e.g. Atomic Energy Control Board licensees who report radiation doses to the National Dose Registry, as well as for other companies and organizations across the country where long term medical follow-up studies are anticipated now or in the future. It may also allow for broader industrial, national and international comparisons. The guideline consists of a two page Individual Identity Summary (IIS): the first page for completion by the individual/employee to give unique identifying information; the second page for the study organizer/employer to include essential additional information (work history etc.). A third optional page can be used by organizations wishing to collect data on children. The Data Collection Package also includes brief explanatory notes, a suggested file record layout and detailed computer coding advice for entering
Ingram, Michael [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Narang, David J. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Mather, Barry A. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Kroposki, Benjamin D. [National Renewable Energy Laboratory (NREL), Golden, CO (United States)
This document is intended to aid in the understanding and application of the New York State Standardized Interconnection Requirements (SIR) and Application Process for New Distributed Generators 5 MW or Less Connected in Parallel with Utility Distribution Systems, and it aims to provide supplemental information and discussion on selected topics relevant to the SIR. This guide focuses on technical issues that have to date resulted in the majority of utility findings within the context of interconnecting photovoltaic (PV) inverters. This guide provides background on the overall issue and related mitigation measures for selected topics, including substation backfeeding, anti-islanding and considerations for monitoring and controlling distributed energy resources (DER).
Kim, Seon Chil; Kwon, Su Ja
As the adoption of PACS and hospital information system among university hospitals and hospital level institutions grows bigger, the need of sharing and transferring medical information among medical institutions is rising. For the medical information, which is saved in the hospital medical system, to be transferred within the same hospital, domestic, or foreign medical institutions, a standard protocol is necessary. But realistically, most of the domestic hospitals do not abide by H7L which is the HIS standard and so, information transferring is not possible as of present. As such, the purpose of this research is to implement the information between HIS and PACS to an international standard by constructing HL7 messages through HL7 Interface, which will eventually make possible information transferring between different hospitals. Our research team has developed a method which will make the PACS equip hospitals that do not follow HL7 standard which will make possible to transfer information between HIS and PACS through HL7 Message. By constructing message files, which follow the form of HL7 Message in the HL7 Interface, they can be transferred to PACS through the ftp protocol. The realization of the HIS/OCS Interface through HL7 enables data transferring between domestic and foreign medical institutions possible by implementing the international standard in the PACS and HIS data transferring process. The HL7 that our research team has developed made patient data transfer between medical institutions possible. The Interface is for a specific system model and in order for the data transfer between different systems to be realized, interfaces that are fit for each system must be needed. If the Interface is improvised and implemented to each hospital's information system, the data sharing among medical institutions can be broadened
...-02] Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure... approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure Hash Standard (SHS... Federal Information Processing Standard (FIPS) Publication 180-4, Secure Hash Standard (SHS). FIPS 180-4...
Turk, R.S.; Bryan, R.E.
Historically, electric nuclear power plant owners, following the completion of construction and startup, have been left with a mountain of hard-copy documents and drawings. Hundreds of thousands of hours are spent searching for relevant documents and, in most cases, the documents found require many other documents and drawings to fully understand the design basis. All too often the information is incomplete, and eventually becomes obsolete. In the U.S., utilities spend millions of dollars to discover design basis information and update as-built data for each plant. This information must then be stored in an easily accessed usable form to assist satisfy regulatory requirements and to improve plant operating efficiency. ABB Combustion Engineering Nuclear Systems (ABB-CE) has an active program to develop a state-of-the-art Plant Information Management System (IMS) for its advanced light water reactor, the System 80+TM Standard Plant Design. This program is supported by ABB's Product Data Management (PDM) and Computer Aided Engineering (CAE) efforts world wide. This paper describes the System 80+ plant IMS and how it will be used during the entire life cycle of the plant. (author)
Turk, R.S.; Bryan, R.E. [ABB Combuions Engineering Nuclear Systems (United States)
Historically, electric nuclear power plant owners, following the completion of construction and startup, have been left with a mountain of hard-copy documents and drawings. Hundreds of thousands of hours are spent searching for relevant documents and, in most cases, the documents found require many other documents and drawings to fully understand the design basis. All too often the information is incomplete, and eventually becomes obsolete. In the U.S., utilities spend millions of dollars to discover design basis information and update as-built data for each plant. This information must then be stored in an easily accessed usable form to assist satisfy regulatory requirements and to improve plant operating efficiency. ABB Combustion Engineering Nuclear Systems (ABB-CE) has an active program to develop a state-of-the-art Plant Information Management System (IMS) for its advanced light water reactor, the System 80+TM Standard Plant Design. This program is supported by ABB's Product Data Management (PDM) and Computer Aided Engineering (CAE) efforts world wide. This paper describes the System 80+ plant IMS and how it will be used during the entire life cycle of the plant. (author)
...; Information Collection; Cost Accounting Standards Administration AGENCY: Department of Defense (DOD), General... collection requirement concerning cost accounting standards administration. Public comments are particularly... Information Collection 9000- 0129, Cost Accounting Standards Administration by any of the following methods...
Cheng, Po-Hsun; Chen, Heng-Shuen; Lai, Feipei; Lai, Jin-Shin
This article illustrates a Web-based health information system that is comprised of specific information exchange standards related to health information for healthcare services in National Taiwan University Health System. Through multidisciplinary teamwork, medical and informatics experts collaborated and studied on system scope definition, standard selection challenges, system implementation barriers, system management outcomes, and further expandability of other systems. After user requirement analysis and prototyping, from 2005 to 2008, an online clinical decision support system with multiple functions of reminding and information push was implemented. It was to replace its original legacy systems and serve among the main hospital and three branches of 180-200 clinics and 7,500-8,000 patient visits per day. To evaluate the effectiveness of this system, user surveys were performed, which revealed that the average score of user satisfaction increased from 2.80 to 3.18 on a 4-point scale. Among the items, especially e-learning for training service, courtesy communications for system requests, and courtesy communications for system operations showed statistically significant improvement. From this study, the authors concluded that standardized information exchange technologies can be used to create a brand new enterprise value and steadily obtain more competitive advantages for a prestige healthcare system.
Synnot, Anneliese; Ryan, Rebecca; Prictor, Megan; Fetherstonhaugh, Deirdre; Parker, Barbara
Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented, for example, on the Internet or on DVD) are one such method. We updated a 2008 review of the effects of these interventions for informed consent for trial participation. To assess the effects of audio-visual information interventions regarding informed consent compared with standard information or placebo audio-visual interventions regarding informed consent for potential clinical trial participants, in terms of their understanding, satisfaction, willingness to participate, and anxiety or other psychological distress. We searched: the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 6, 2012; MEDLINE (OvidSP) (1946 to 13 June 2012); EMBASE (OvidSP) (1947 to 12 June 2012); PsycINFO (OvidSP) (1806 to June week 1 2012); CINAHL (EbscoHOST) (1981 to 27 June 2012); Current Contents (OvidSP) (1993 Week 27 to 2012 Week 26); and ERIC (Proquest) (searched 27 June 2012). We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions. We included randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or verbal information), with standard forms of information provision or placebo audio-visual information, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to consider participating in a real or hypothetical clinical study. (In the earlier version of this review we only included studies evaluating informed consent interventions for real studies). Two authors independently assessed studies for inclusion and extracted data. We synthesised the findings
...-02] Announcing Draft Federal Information Processing Standard 180-4, Secure Hash Standard, and Request... and request for comments. SUMMARY: This notice announces the Draft Federal Information Processing..., Information Technology Laboratory, Attention: Comments on Draft FIPS 180-4, 100 Bureau Drive--Stop 8930...
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
Baek, Young Jin; Oh, Na Gyeong; Sohn, Cheong-Min; Woo, Mi-Hye; Lee, Seung Min; Ju, Dal Lae; Seo, Jung-Sook
This study was conducted to evaluate applicability of job standards for diabetes nutrition management by hospital clinical dietitians. In order to promote the clinical nutrition services, it is necessary to present job standards of clinical dietitian and to actively apply these standardized tasks to the medical institution sites. The job standard of clinical dietitians for diabetic nutrition management was distributed to hospitals over 300 beds. Questionnaire was collected from 96 clinical di...
Manfredi, Matteo; Mele, Fabrizio; Garrou, Diletta; Walz, Jochen; Fütterer, Jurgen J; Russo, Filippo; Vassallo, Lorenzo; Villers, Arnauld; Emberton, Mark; Valerio, Massimo
Multiparametric prostate MRI (mp-MRI) is an emerging imaging modality for diagnosis, characterization, staging, and treatment planning of prostate cancer (PCa). The technique, results reporting, and its role in clinical practice have been the subject of significant development over the last decade. Although mp-MRI is not yet routinely used in the diagnostic pathway, almost all urological guidelines have emphasized the potential role of mp-MRI in several aspects of PCa management. Moreover, new MRI sequences and scanning techniques are currently under evaluation to improve the diagnostic accuracy of mp-MRI. This review presents an overview of mp-MRI, summarizing the technical applications, the standardized reporting systems used, and their current roles in various stages of PCa management. Finally, this critical review also reports the main limitations and future perspectives of the technique.
...-03] NIST Federal Information Processing Standard (FIPS) 140-3 (Second Draft), Security Requirements....'' Authority: Federal Information Processing Standards (FIPS) are issued by the National Institute of Standards... Standards and Technology (NIST) seeks additional comments on specific sections of Federal Information...
Grønvold, Mogens; Petersen, Morten Aagaard; Damkier, Anette
Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients...
Richesson, Rachel L; Malloy, Jamie F; Paulus, Kathleen; Cuthbertson, David; Krischer, Jeffrey P
Multi-site clinical protocols and clinical research networks require tools to manage and monitor adverse events (AEs). To be successful, these tools must be designed to comply with applicable regulatory requirements, reflect current data standards, international directives and advances in pharmacovigilance, and be convenient and adaptable to multiple needs. We describe an Adverse Event Data Management System (AEDAMS) that is used across multiple study designs in the various clinical research networks and multi-site studies for which we provide data and technological support. Investigators enter AE data using a standardized and structured web-based data collection form. The automated AEDAMS forwards the AE information to individuals in designated roles (investigators, sponsors, Data Safety and Monitoring Boards) and manages subsequent communications in real time, as the entire reporting, review and notification is done by automatically generated emails. The system was designed to adhere to timelines and data requirements in compliance with Good Clinical Practice (International Conference on Harmonisation E6) reporting standards and US federal regulations, and can be configured to support AE management for many types of study designs and adhere to various domestic or international reporting requirements. This tool allows AEs to be collected in a standard way by multiple distributed users, facilitates accurate and timely AE reporting and reviews, and allows the centralized management of AEs. Our design justification and experience with the system are described.
Fuchs, Anke; Gliwiński, Mateusz; Grageda, Nathali; Spiering, Rachel; Abbas, Abul K; Appel, Silke; Bacchetta, Rosa; Battaglia, Manuela; Berglund, David; Blazar, Bruce; Bluestone, Jeffrey A; Bornhäuser, Martin; Ten Brinke, Anja; Brusko, Todd M; Cools, Nathalie; Cuturi, Maria Cristina; Geissler, Edward; Giannoukakis, Nick; Gołab, Karolina; Hafler, David A; van Ham, S Marieke; Hester, Joanna; Hippen, Keli; Di Ianni, Mauro; Ilic, Natasa; Isaacs, John; Issa, Fadi; Iwaszkiewicz-Grześ, Dorota; Jaeckel, Elmar; Joosten, Irma; Klatzmann, David; Koenen, Hans; van Kooten, Cees; Korsgren, Olle; Kretschmer, Karsten; Levings, Megan; Marek-Trzonkowska, Natalia Maria; Martinez-Llordella, Marc; Miljkovic, Djordje; Mills, Kingston H G; Miranda, Joana P; Piccirillo, Ciriaco A; Putnam, Amy L; Ritter, Thomas; Roncarolo, Maria Grazia; Sakaguchi, Shimon; Sánchez-Ramón, Silvia; Sawitzki, Birgit; Sofronic-Milosavljevic, Ljiljana; Sykes, Megan; Tang, Qizhi; Vives-Pi, Marta; Waldmann, Herman; Witkowski, Piotr; Wood, Kathryn J; Gregori, Silvia; Hilkens, Catharien M U; Lombardi, Giovanna; Lord, Phillip; Martinez-Caceres, Eva M; Trzonkowski, Piotr
Cellular therapies with CD4+ T regulatory cells (Tregs) hold promise of efficacious treatment for the variety of autoimmune and allergic diseases as well as posttransplant complications. Nevertheless, current manufacturing of Tregs as a cellular medicinal product varies between different laboratories, which in turn hampers precise comparisons of the results between the studies performed. While the number of clinical trials testing Tregs is already substantial, it seems to be crucial to provide some standardized characteristics of Treg products in order to minimize the problem. We have previously developed reporting guidelines called minimum information about tolerogenic antigen-presenting cells, which allows the comparison between different preparations of tolerance-inducing antigen-presenting cells. Having this experience, here we describe another minimum information about Tregs (MITREG). It is important to note that MITREG does not dictate how investigators should generate or characterize Tregs, but it does require investigators to report their Treg data in a consistent and transparent manner. We hope this will, therefore, be a useful tool facilitating standardized reporting on the manufacturing of Tregs, either for research purposes or for clinical application. This way MITREG might also be an important step toward more standardized and reproducible testing of the Tregs preparations in clinical applications.
Full Text Available Cellular therapies with CD4+ T regulatory cells (Tregs hold promise of efficacious treatment for the variety of autoimmune and allergic diseases as well as posttransplant complications. Nevertheless, current manufacturing of Tregs as a cellular medicinal product varies between different laboratories, which in turn hampers precise comparisons of the results between the studies performed. While the number of clinical trials testing Tregs is already substantial, it seems to be crucial to provide some standardized characteristics of Treg products in order to minimize the problem. We have previously developed reporting guidelines called minimum information about tolerogenic antigen-presenting cells, which allows the comparison between different preparations of tolerance-inducing antigen-presenting cells. Having this experience, here we describe another minimum information about Tregs (MITREG. It is important to note that MITREG does not dictate how investigators should generate or characterize Tregs, but it does require investigators to report their Treg data in a consistent and transparent manner. We hope this will, therefore, be a useful tool facilitating standardized reporting on the manufacturing of Tregs, either for research purposes or for clinical application. This way MITREG might also be an important step toward more standardized and reproducible testing of the Tregs preparations in clinical applications.
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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
Pedersen, Mogens Kuhn; Fomin, Vladislav V.
processes in the field of ICT taking place? How and why do open standards differ from other types of standards? How may open standards influence ICT government policy and the reverse: How will government need to take action in the face of the international trend toward open standards in ICT?...
... Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for... Health Information Technology AGENCY: Office of the National Coordinator for Health Information... information technology, including changing the program's name to the ONC HIT Certification Program. DATES...
Rosenstein, A H
This article provides a consultant's account of a 250-bed community hospital's experience in implementing the Clinical Resource Management (CRM) program, a four-stage process of using information to identify opportunities for improvement, developing an effective resource management team, implementing process improvement activities, and measuring the impact on outcomes of care. CASE STUDY EXAMPLE--CONGESTIVE HEART FAILURE: The chair of the departments of internal medicine and family practice selected congestive heart failure for in-depth study. A task force focused on treatment and patient disposition in the emergency room (ER), where most of the nonelective admissions originated. A set of standardized ER orders was developed that emphasized rapid and effective diuresis through the initiation of a progressive diuretic dosing schedule directly linked to patient response. Factors critical to the success of the CRM program included allocating adequate time to promote and sell the value and importance of the program, as well as securing the support of both information systems and physicians. The main barriers to success involved limitations in the information system infrastructure and delays attributable to committee review. Short-term results from the CRM program were encouraging, with average lengths of stay reduced by 0.5 days and average costs of care reduced by 12% for the ten diagnoses studied with no adverse results. Nonstudy diagnoses showed no notable improvement. Recognizing the growing importance of information management not only for clinical decision support but for accommodating all the necessary internal and external reporting requirements will require a significant commitment and investment in technology and personnel resources.
Viergever Roderik F
Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.
International standards are indispensable for the LHC and its experiments. The CERN Library is establishing a service to facilitate access to standards documentation. Although there will only be one of it, the LHC will conform to international standards, as will its four experiments. For even though an LHC, ALICE, ATLAS, CMS, or LHCb cannot be bought off the shelf, many of the components that go into them can. Moreover, thanks to the International Standards Organization (ISO), we have standards such as ISO 9000 for quality management and assurance, and ISO 14000 for environmental management. All suppliers of equipment for the LHC are expected to adhere to both. Marcel Mottier, responsible for the LHC's quality assurance plan, consults the ISO 9000, the quality management 'Bible'. The library is making all standards documentation held at the laboratory available for all to consult. A standard is a documented agreement containing technical specifications or other precise criteria to be used consistently as r...
... provided in the desired format, reporting burden (time and financial resources) is minimized, collection... Information Collection; Health Standards for Diesel Particulate Matter Exposure (Underground Coal Mines... extension of the information collection for Health Standards for Diesel Particulate Matter Exposure...
Functional diagnosis of consciousness disturbance (CD) in acute and chronic stages is becoming more important along with the progress of morphological diagnosis by CT and MRI at the stroke and brain lesion. Here described and discussed are the definition of consciousness and unconsciousness, cause and scoring of CD by various scaling and clinical significance of the scale for therapy. The author's definition for consciousness is based on patients' self identity and orientation. The above CD is essentially caused by the increased intracranial pressure, which is evaluable by imaging as the increase is derived from the herniation by tumor or edema mainly through transtentorial (uncal, hippocampal) and/or foraminal (cerebellar tonsillar) pathways. Scaling of CD stands on three factors of validity, reliability and feasibility, of which standards of JCS (Japan coma scale) and GCS (Glasgow coma scale) have been widely employed. In discussion of merit/demerit of JCS and GCS, the author et al. have proposed a new scale ECS (emergency coma scale) with 3 levels of digit code for patient's response and behavior under CD. Therapeutic outcome is greatly affected by acute CD levels evaluable by scaling, in which awakening/alertness relates with mortality, and local symptom/consciousness, with morbidity. ECS is now globally getting around. (K.T.)
... 45 Public Welfare 1 2010-10-01 2010-10-01 false Vocabulary standards for representing electronic... Specifications for Health Information Technology § 170.207 Vocabulary standards for representing electronic... vocabulary standards for the purpose of representing electronic health information: (a) Problems—(1) Standard...
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.
The role of international regulatory standards within the current global environment has become of the most importance. The age of the global system and free market capitalism carried us into the unprecedented age of regulations, and standard setting. Regulations are now becoming the emerging mode of global governance. This study focuses on…
Cox, Richard J.
Discussion of the use of standards by archivists highlights the U.S. MARC AMC (Archives-Manuscript Control) format for reporting archival records and manuscripts; their interest in specific standards being developed for the OSI (Open Systems Interconnection) reference model; and the management of records in electronic formats. (16 references) (LAE)
In a bid to attract students amidst increasing competition within the sector, many universities claim that their teaching is “research-informed”. However, there is some disagreement amongst academics about what actually counts as research-informed teaching and therefore how it should be developed and delivered. Furthermore, whilst academic reputation is a key factor for prospective university applicants, the primary\\ud objective of the majority is to enhance employability. Institutions must t...
Voluntary informed consent for participation in clinical research is the cornerstone of health research ethics and a requirement for clinical research in South Africa. The South African-specific guidance documents concerning voluntary informed consent provisions differ and sometimes contradict international documents.
This descriptive survey was conducted among private clinics located in Ilorin, Kwara State, Nigeria to determine the awareness and level of involvement of private clinic operators towards the National Health Management Information System. A total of 37 functional clinics responded to the survey. Structured questionnaire ...
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.
Dellson, Pia; Nilbert, Mef; Carlsson, Christina
responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development......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...... consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. METHODS: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I...
Informed Consent for Inclusion into Clinical Trials: A Serious Subject to Note in the Developing World Morteza. ... Review: The process of taking informed consent is wellunderstood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of ...
This report contains information concerning: operational radionuclide control; occupational radiation protection, conduct of operations; initial test program; safety analysis; technical specifications; and quality assurance. (JDB)
Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, it is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented
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.
The article regards some requirements concerning information literacy and competences which have been exhaustively determined by Association of College and Research Libraries (ACRL). On their basis the ACRL Anthropology and Sociology Section (ANSS) has determined some indicators of the students’ information literacy development . These indicators are oriented towards a research process’ methodology and tools in cultural anthropology, biological anthropology, linguistic anthropology, archeo...
This project will help African countries develop and maintain low-cost sustainable health information systems, and use the information systems to address health ... of experts in medical informatics and computing; and a methodology for leveraging open source software and techniques for improved health data management.
Kiriakou, Charles M.
Adoption of a comprehensive information security governance model and security controls is the best option organizations may have to protect their information assets and comply with regulatory requirements. Understanding acceptance factors of the National Institute of Standards and Technology (NIST) Risk Management Framework (RMF) comprehensive…
Full Text Available HIV/AIDS is one of life-threatening diseases over which human currently does not have enough control. Study and research on HIV and its prevention are being carried out by different organizations. However, they are mostly area specific, thereby, failing to provide a nation-wide or region-wide overview of HIV infection. One of the major bottlenecks in having a wider study is the lack of interoperability among systems managing HIV patient information. Besides, such lack of interoperability also hinders forming larger HIV care network where telemedicine could be accomplished more effectively. We have addressed this interoperability issue through HL7 clinical document architecture (CDA, a document-based messaging standard for clinical interaction. This article introduces a document architecture that conforms to HL7 CDA standard and contains all relevant information of a pediatric HIV patient. We extended the existing architecture of CDA consultation note in three dimensions: (1 HIV specific content, (2 HIV specific knowledgebase and (3 HIV specific presentation of content and knowledge. An example CDA consultation note is demonstrated following the proposed extension.
Spurgeon, Jonathan J.; Stewart, Nathaniel T.; Pegg, Mark A.; Pope, Kevin L.; Porath, Mark T.
Lakes and reservoirs progress through an aging process often accelerated by human activities, resulting in degradation or loss of ecosystem services. Resource managers thus attempt to slow or reverse the negative effects of aging using a myriad of rehabilitation strategies. Sustained monitoring programs to assess the efficacy of rehabilitation strategies are often limited; however, long-term standardized fishery surveys may be a valuable data source from which to begin evaluation. We present 3 case studies using standardized fishery survey data to assess rehabilitation efforts stemming from the Nebraska Aquatic Habitat Plan, a large-scale program with the mission to rehabilitate waterbodies within the state. The case studies highlight that biotic responses to rehabilitation efforts can be assessed, to an extent, using standardized fishery data; however, there were specific areas where minor increases in effort would clarify the effectiveness of rehabilitation techniques. Management of lakes and reservoirs can be streamlined by maximizing the utility of such datasets to work smarter, not harder. To facilitate such efforts, we stress collecting both biotic (e.g., fish lengths and weight) and abiotic (e.g., dissolved oxygen, pH, and turbidity) data during standardized fishery surveys and designing rehabilitation actions with an appropriate experimental design.
... include average firm size, startup costs and entry barriers, industry competition, and distribution of... standard lower than the anchor. 2. Startup costs and entry barriers. Startup costs reflect a firm's initial... 63216-63229] [FR Doc No: 2011-26208] SMALL BUSINESS ADMINISTRATION 13 CFR Part 121 RIN 3245-AG26 Small...
Barut, Cagatay; Ertilav, Hakan
Photography has a widespread usage in medicine and anatomy. In this review, authors focused on the usage of photography in gross and clinical anatomy. Photography in gross and clinical anatomy is not only essential for accurate documentation of morphological findings but also important in sharing knowledge and experience. Photographs of cadavers…
Leslie, Heather; Ljosland Bakke, Silje
Over the past 8 years the openEHR Clinical Model program has been developing a Web 2.0 approach and tooling to support the development, review and governance of atomic clincial information models, known as archetypes. This paper describes the background and review process, and provides a practical example where cross standards organisation collaboration resulted in jointly agreed clinical content which was subsequently represented in different implementation formalisms that were effectively semantically aligned. The discussion and conclusions highlight some of the socio-technical benefits and challenges facing organisations who seek to govern automic clinical information models in a global and collaborative online community.
...-01] Announcing DRAFT Revisions to Federal Information Processing Standard (FIPS) 186-3, Digital... Technology (NIST) requests comments on revisions to Federal Information Processing Standard (FIPS) 186-3... 25, 2012. ADDRESSES: Written comments may be sent to: Chief, Computer Security Division, Information...
... Information Collection: Uniform Physical Standards and Physical Inspection Requirements AGENCY: Office of the... Information Collection Title of Information Collection: Uniform Physical Standards and Physical Inspection... for conducting physical inspections of the properties are HUD, the lender or the owner. Owners/Agents...
... Part 170 Health Information Technology: Standards, Implementation Specifications, and Certification... Program for Health Information Technology; Proposed Rule #0;#0;Federal Register / Vol. 77 , No. 45... Office of the Secretary 45 CFR Part 170 RIN 0991-AB82 Health Information Technology: Standards...
... SECURITY Chemical Facility Anti-Terrorism Standards (CFATS) Chemical- Terrorism Vulnerability Information... Collection Request, Chemical Facility Anti- Terrorism Standards (CFATS) Chemical-terrorism Vulnerability... chemical facilities. On April 9, 2007, the Department issued an Interim Final Rule (IFR), implementing this...
Gastroenterology is one of the important specialities in internal medicine. The reform of the training curriculum for internal medicine and the reimbursement for inpatient and outpatient services in gastroenterology threatens the existence of internal medicine and gastroenterology in Germany, too. The capacity for training in internal medicine and gastroenterology is reduced by a decrease in the number of hospital beds in academic and community training centres. The concentration on gastrointestinal endoscopy in outpatient gastroenterology will be a result of an increasing demand for gastrointestinal endoscopy services and the decreasing number of gastroenterology clinics, respectively. Therefore, clinical gastroenterology as a core service in gastroenterology will be steadily eliminated. This development will diminish clinical gastroenterology to gastrointestinal endoscopy by eliminating the clinical services for chronic gastroenterological conditions such as, e.g., IBD, chronic hepatitis, reflux disease, IBS and functional dyspepsia. In this way gastroenterology looses its central role in health care services in specialised internal medicine. In 2003 the American Gastroenterological Association position paper: "Training the Gastroenterologist of the Future: the Gastroenterology Core Curriculum" was published. It has emphasised the role of clinical gastroenterology in medical training and medical services, too. Clinical gastroenterology consists of an array of several disciplines, e.g., GI physiology, GI research, infectious diseases, hepatology, oncology and gastrointestinal endoscopy, which all contribute to the effectiveness and efficiency in health care service. Financial incentives and better prospects of leading positions for young gastroenterologists in clinical gastroenterology have to be accomplished in order to nourish clinical gastroenterology in Germany. The German Association of Gastroenterology should negotiate with the responsible authorities for
Luksamijarulkul, Pipat; Panya, Navapan; Sujirarat, Dusit; Thaweboon, Sroisiri
A cross-sectional study was carried out to assess standard precaution practices among dental personnel and to investigate microbial counts in indoor air samples collected from a hospital dental clinic before and during dental works. Thirty dental personnel who voluntarily participated were interviewed using a questionnaire towards demographic information and standard precaution practices between May and August 2007. Additionally, 138 indoor air samples (72 from dental treatment units, 48 from dental supporting units and offices and 18 from patient waiting area) were collected before and during dental works for 6 days (Monday to Saturday) to investigate bacterial and fungal counts. Data were analyzed by using descriptive statistics. Paired t-test was used for analyzing the difference of mean + standard deviation between microbial counts before and during dental procedures. The statistical significance was expressed in term of p-value and the critical level was set at alpha = 0.05. The results revealed that standard precaution practices towards wearing personal protective equipments regularly during dental procedures ranged from 50% to 100%, whereas, cleaning and disinfecting dental unit after each patient treatment and cleaning dental unit water lines with antiseptics every week were done regularly only 36.7%. The mean score of standard precaution was 8.4 +/- 2.5 (moderate level, total score of 13). The means of bacterial and fungal counts in air samples collected from dental treatment units significantly increased during dental procedures when compared with those collected before dental works (p 0.05. This study demonstrated the moderate level of standard precaution practice score among studied dental personnel and significantly higher microbial counts (bacterial and fungal counts) in air samples collected from dental treatment units during dental procedures were demonstrated. To reduce the occupational risk among this group, standard precaution practices should be
Currie, Colin T; Hutchison, James D
To report on experience of national-level audit, guidelines and standards for hip fracture care in Scotland. Scottish Hip Fracture Audit (from 1993) documents case-mix, process and outcomes of hip fracture care in Scotland. Evidence-based national guidelines on hip fracture care are available (1997, updated 2002). Hip fracture serves as a tracer condition by the health quality assurance authority for its work on older people, which reported in 2004. Audit data are used locally to document care and support and monitor service developments. Synergy between the guidelines and the audit provides a means of improving care locally and monitoring care nationally. External review by the quality assurance body shows to what extent guideline-based standards relating to A&E care, pre-operative delay, multidisciplinary care and audit participation are met. Three national-level initiatives on hip fracture care have delivered: Reliable and large-scale comparative information on case-mix, care and outcomes; evidence-based recommendations on care; and nationally accountable standards inspected and reported by the national health quality assurance authority. These developments are linked and synergistic, and enjoy both clinical and managerial support. They provide an evolving framework for clinical governance, with casemix-adjusted outcome assessment for hip fracture care as a next step.
Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha
Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .
An overview of the five volume set of Information System Life-Cycle and Documentation Standards is provided with information on its use. The overview covers description, objectives, key definitions, structure and application of the standards, and document structure decisions. These standards were created to provide consistent NASA-wide structures for coordinating, controlling, and documenting the engineering of an information system (hardware, software, and operational procedures components) phase by phase.
network. There is a perceived requirement for an ultimate delivery capability, whereby important communications are sustained , even at very low data...Transfer Layer in RTTS developed in France for use in LANs (see Section 15.4.4) [Ref. GAM 1987]. XTP is designed to support 100 Mbps sustained transfer...10746-2U_____ Fmeo for OOP standards WD 10748-3 ___ User %*IQ W 10746-4 Architectura semantics. formalismns W 04- Key: E3 v 015I EM o/CD U ISO G-4
Health care across much of the African continent is hampered by meager resources and a growing burden of disease, with HIV/AIDS, tuberculosis (TB) and malaria leading the charge. Timely, accurate, affordable and appropriate information plays a critical role in patient care delivery and public health management.
2013 updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy.
Neuss, Michael N; Polovich, Martha; McNiff, Kristen; Esper, Peg; Gilmore, Terry R; LeFebvre, Kristine B; Schulmeister, Lisa; Jacobson, Joseph O
In 2009, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) published standards for the safe use of parenteral chemotherapy in the outpatient setting, including issues of practitioner orders, preparation, and administration of medication. In 2011, these were updated to include inpatient facilities. In December 2011, a multistakeholder workgroup met to address the issues associated with orally administered antineoplastics, under the leadership of ASCO and ONS. The workgroup participants developed recommended standards, which were presented for public comment. Public comments informed final edits, and the final standards were reviewed and approved by the ASCO and ONS Boards of Directors. Significant newly identified recommendations include those associated with drug prescription and the necessity of ascertaining that prescriptions are filled. In addition, the importance of patient and family education regarding administration schedules, exception procedures, disposal of unused oral medication, and aspects of continuity of care across settings were identified. This article presents the newly developed standards.
M.R. Flynn (Rachel); C. Barrett (Conor); F.G. Cosio (Francisco); A.K. Gitt (Anselm); L.C. Wallentin (Lars); P. Kearney (Peter); M. Lonergan (Moira); E. Shelley (Emer); M.L. Simoons (Maarten)
textabstractAIMS: Systematic registration of data from clinical practice is important for clinical care, local, national and international registries, and audit. Data to be collected for these different purposes should be harmonized. Therefore, during Ireland's Presidency of the European Union (EU)
Biering-Sørensen, Fin; Noonan, Vanessa K.
Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able to be uniformly collected at any SCI center or within any SCI study. Standardization will make it possible to collect information from larger SCI populations for multi-center research studies. With this aim, the international SCI community has obtained consensus regarding the best available data and measures for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society’s International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements Project within SCI and discuss future opportunities. PMID:27529284
Informed Consent for Inclusion into Clinical Trials: A Serious Subject to Note in the Developing World Morteza. ... Arab Journal of Nephrology and Transplantation ... 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 ...
Informed consent is a primary precondition of legal and ethical clinical research and is regarded as the ... on the ethical principle of respect for personal autonomy, informed consent flows from the ..... Ethics. Chichester: John Wiley & Sons, 1994: 63-64, where he presents Kant's argument in favour of respecting autonomy.) 3.
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......This paper describes the role of simulation involving end-users in Health Informatics. Simulation has long been established as a widely accepted method in clinical skills training. During the last decade simulation has also gained a place in the development and evaluation of clinical information...... 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...
Wiltz, Jennifer L; Blanck, Heidi M; Lee, Brian; Kocot, S Lawrence; Seeff, Laura; McGuire, Lisa C; Collins, Janet
Electronic information technology standards facilitate high-quality, uniform collection of data for improved delivery and measurement of health care services. Electronic information standards also aid information exchange between secure systems that link health care and public health for better coordination of patient care and better-informed population health improvement activities. We developed international data standards for healthy weight that provide common definitions for electronic information technology. The standards capture healthy weight data on the "ABCDs" of a visit to a health care provider that addresses initial obesity prevention and care: assessment, behaviors, continuity, identify resources, and set goals. The process of creating healthy weight standards consisted of identifying needs and priorities, developing and harmonizing standards, testing the exchange of data messages, and demonstrating use-cases. Healthy weight products include 2 message standards, 5 use-cases, 31 LOINC (Logical Observation Identifiers Names and Codes) question codes, 7 healthy weight value sets, 15 public-private engagements with health information technology implementers, and 2 technical guides. A logic model and action steps outline activities toward better data capture, interoperable systems, and information use. Sharing experiences and leveraging this work in the context of broader priorities can inform the development of electronic information standards for similar core conditions and guide strategic activities in electronic systems.
Nakajima, Kenichi; Verschure, Derk O.; Okuda, Koichi; Verberne, Hein J.
Purpose Myocardial sympathetic imaging with I-123-meta-iodobenzylguanidine (I-123-mIBG) has gained clinical momentum. Although the need for standardization of I-123-mIBG myocardial uptake has been recognized, the availability of practical clinical standardization approaches is limited. The need for
O'Sullivan, S S
BACKGROUND: The EEG is a commonly requested test on patients attending psychiatric services, predominantly to investigate for a possible organic brain syndrome causing behavioural changes. AIMS: To assess referrals for EEG from psychiatric services in comparison with those from other sources. We determine which clinical factors were associated with an abnormal EEG in patients referred from psychiatric sources. METHODS: A retrospective review of EEG requests in a 1-year period was performed. Analysis of referral reasons for psychiatric patients was undertaken, and outcome of patients referred from psychiatric services post-EEG was reviewed. RESULTS: One thousand four hundred and seventy EEGs were reviewed, of which 91 (6.2%) were referred from psychiatry. Neurology service referrals had detection rates of abnormal EEGs of 27%, with psychiatric referrals having the lowest abnormality detection rate of 17.6% (p < 0.1). In psychiatric-referred patients the only significant predictors found of an abnormal EEG were a known history of epilepsy (p < 0.001), being on clozapine (p < 0.05), and a possible convulsive seizure (RR = 6.51). Follow-up data of 53 patients did not reveal a significant clinical impact of EEG results on patient management. CONCLUSIONS: Many patients are referred for EEG from psychiatric sources despite a relatively low index of suspicion of an organic brain disorders, based on reasons for referral documented, with an unsurprising low clinical yield.
Huang, Hui; Shen, Yiping; Gu, Weihong; Wang, Wei; Wang, Yiming; Qi, Ming; Shen, Jun; Qiu, Zhengqing; Yu, Shihui; Zhou, Zaiwei; Chen, Baixue; Chen, Lei; Chen, Yundi; Cui, Huanhuan; Du, Juan; Gao, Yong; Guo, Yiran; Hu, Chanjuan; Hu, Liang; Huang, Yi; Li, Peipei; Li, Xiaorong; Li, Xiurong; Liu, Yaping; Lu, Jie; Ma, Duan; Ma, Yongyi; Peng, Mei; Song, Fang; Sun, Hongye; Wang, Liang; Wang, Dawei; Wang, Jingmin; Wang, Ling; Wang, Zhengyuan; Wang, Zhinong; Wu, Jihong; Wu, Jing; Wu, Jian; Xu, Yimin; Yao, Hong; Yang, Dongsheng; Yang, Xu; Yang, Yanling; Zhang, Ying; Zhou, Yulin; Zhu, Baosheng; Zeng, Sicong; Peng, Zhiyu; Huang, Shangzhi
The widespread application of next generation sequencing (NGS) in clinical settings has enabled testing, diagnosis, treatment and prevention of genetic diseases. However, many issues have arisen in the meanwhile. One of the most pressing issues is the lack of standards for reporting genetic test results across different service providers. The First Forum on Standards and Specifications for Clinical Genetic Testing was held to address the issue in Shenzhen, China, on October 28, 2017. Participants, including geneticists, clinicians, and representatives of genetic testing service providers, discussed problems of clinical genetic testing services across in China and shared opinions on principles, challenges, and standards for reporting clinical genetic test results. Here we summarize expert opinions presented at the seminar and report the consensus, which will serve as a basis for the development of standards and guidelines for reporting of clinical genetic testing results, in order to promote the standardization and regulation of genetic testing services in China.
Amin, Waqas; Parwani, Anil V; Schmandt, Linda; Mohanty, Sambit K; Farhat, Ghada; Pople, Andrew K; Winters, Sharon B; Whelan, Nancy B; Schneider, Althea M; Milnes, John T; Valdivieso, Federico A; Feldman, Michael; Pass, Harvey I; Dhir, Rajiv; Melamed, Jonathan; Becich, Michael J
Advances in translational research have led to the need for well characterized biospecimens for research. The National Mesothelioma Virtual Bank is an initiative which collects annotated datasets relevant to human mesothelioma to develop an enterprising biospecimen resource to fulfill researchers' need. The National Mesothelioma Virtual Bank architecture is based on three major components: (a) common data elements (based on College of American Pathologists protocol and National North American Association of Central Cancer Registries standards), (b) clinical and epidemiologic data annotation, and (c) data query tools. These tools work interoperably to standardize the entire process of annotation. The National Mesothelioma Virtual Bank tool is based upon the caTISSUE Clinical Annotation Engine, developed by the University of Pittsburgh in cooperation with the Cancer Biomedical Informatics Grid (caBIG, see http://cabig.nci.nih.gov). This application provides a web-based system for annotating, importing and searching mesothelioma cases. The underlying information model is constructed utilizing Unified Modeling Language class diagrams, hierarchical relationships and Enterprise Architect software. The database provides researchers real-time access to richly annotated specimens and integral information related to mesothelioma. The data disclosed is tightly regulated depending upon users' authorization and depending on the participating institute that is amenable to the local Institutional Review Board and regulation committee reviews. The National Mesothelioma Virtual Bank currently has over 600 annotated cases available for researchers that include paraffin embedded tissues, tissue microarrays, serum and genomic DNA. The National Mesothelioma Virtual Bank is a virtual biospecimen registry with robust translational biomedical informatics support to facilitate basic science, clinical, and translational research. Furthermore, it protects patient privacy by disclosing only
Sharma, Sangeeta; Pandit, Ajay; Tabassum, Fauzia
Purpose The purpose of this paper is to assess medicines information sources accessed by clinicians, if sources differed in theory and practice and to find out the barriers and facilitators to effective guideline adoption. Design/methodology/approach In all, 183 doctors were surveyed. Barriers and facilitators were classified as: communication; potential adopters; innovation; organization characteristics and environmental/social/economic context. Findings Most of the clinicians accessed multiple information sources including standard treatment guidelines, but also consulted seniors/colleagues in practice. The top three factors influencing clinical practice guideline adoption were innovation characteristics, environmental context and individual characteristics. The respondents differed in the following areas: concerns about flexibility offered by the guideline; denying patients' individuality; professional autonomy; insights into gaps in current practice and evidence-based practice; changing practices with little or no benefit. Barriers included negative staff attitudes/beliefs, guideline integration into organizational structures/processes, time/resource constraints. Fearing third parties (government and insurance companies) restricting medicines reimbursement and poor liability protection offered by the guidelines emerged as the barriers. Facilitators include aligning organizational structures/processes with the innovation; providing leadership support to guide diffusion; increasing awareness and enabling early innovation during pre/in-service training, with regular feedback on outcomes and use. Practical implications Guideline adoption in clinical practice is partly within doctors' control. There are other key prevailing factors in the local context such as environmental, social context, professional and organizational culture affecting its adoption. Organizational policy and accreditation standards necessitating adherence can serve as a driver. Originality
Valdivieso Federico A
Full Text Available Abstract Background Advances in translational research have led to the need for well characterized biospecimens for research. The National Mesothelioma Virtual Bank is an initiative which collects annotated datasets relevant to human mesothelioma to develop an enterprising biospecimen resource to fulfill researchers' need. Methods The National Mesothelioma Virtual Bank architecture is based on three major components: (a common data elements (based on College of American Pathologists protocol and National North American Association of Central Cancer Registries standards, (b clinical and epidemiologic data annotation, and (c data query tools. These tools work interoperably to standardize the entire process of annotation. The National Mesothelioma Virtual Bank tool is based upon the caTISSUE Clinical Annotation Engine, developed by the University of Pittsburgh in cooperation with the Cancer Biomedical Informatics Grid™ (caBIG™, see http://cabig.nci.nih.gov. This application provides a web-based system for annotating, importing and searching mesothelioma cases. The underlying information model is constructed utilizing Unified Modeling Language class diagrams, hierarchical relationships and Enterprise Architect software. Result The database provides researchers real-time access to richly annotated specimens and integral information related to mesothelioma. The data disclosed is tightly regulated depending upon users' authorization and depending on the participating institute that is amenable to the local Institutional Review Board and regulation committee reviews. Conclusion The National Mesothelioma Virtual Bank currently has over 600 annotated cases available for researchers that include paraffin embedded tissues, tissue microarrays, serum and genomic DNA. The National Mesothelioma Virtual Bank is a virtual biospecimen registry with robust translational biomedical informatics support to facilitate basic science, clinical, and translational
... SECURITY Chemical Facility Anti-Terrorism Standards (CFATS) Chemical- Terrorism Vulnerability Information... financial information, Chemical-terrorism Vulnerability Information (CVI), Sensitive Security Information... security of high-risk chemical facilities. On April 9, 2007, the Department issued an Interim Final Rule...
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.
Toluene is a colorless, volatile liquid with a benzene-like odour. Its predominant use is in the production of benzene, as an octane enhancer in gasoline, as a solvent in aerosol spray paints, wall paints, lacquers, inks, adhesives, resins, and in such consumer products as spot removers, paint strippers, cosmetics, perfumes and antifreezes. Approximately 150 Ontario industrial sources reported toluene releases to the air totaling 4,245 to 5,300 tonnes during the reporting years from 1993 to 1996, making toluene one of the top pollutants by release quantities in Ontario and Canada for all these years. It is absorbed via the lungs and the gastrointestinal tract, both in humans and animals. Once absorbed, it tends to accumulate in the fatty tissues, and in vascularized tissues such as nerve cells and brain tissue. Toluene adversely affects the central nervous system (CNS) of humans and experimental animals. Observed symptoms in exposed humans range from decrease in psychometric performance, to headache, intoxication, convulsions, narcosis and death. Health Canada concluded that toluene is unlikely to be carcinogenic, although the available data is insufficient for definite classification. Ontario has 24-hour ambient air quality criterion and a half-hour Point of Impingement standard for toluene of 2,000 microgram/cubic meter, based on odour effects. The US Environmental Protection Agency inhalation reference concentration (also adopted by most of the American states) is 400 microgram/cubic meter. The WHO recommended a guideline value of 7500 microgram/cubic meter. Health Canada And Environment Canada established a tolerable concentration of 3750 microgram/cubic meter. 69 refs., 2 tabs., appendix
LaChance, Jeffrey L.; Houf, William G. (Sandia National Laboratories, Livermore, CA); Fluer, Inc., Paso Robels, CA; Fluer, Larry (Fluer, Inc., Paso Robels, CA); Middleton, Bobby
The development of a set of safety codes and standards for hydrogen facilities is necessary to ensure they are designed and operated safely. To help ensure that a hydrogen facility meets an acceptable level of risk, code and standard development organizations are tilizing risk-informed concepts in developing hydrogen codes and standards.
"Heidelberg standard examination" and "Heidelberg standard procedures" - Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education.
Nikendei, C; Ganschow, P; Groener, J B; Huwendiek, S; Köchel, A; Köhl-Hackert, N; Pjontek, R; Rodrian, J; Scheibe, F; Stadler, A-K; Steiner, T; Stiepak, J; Tabatabai, J; Utz, A; Kadmon, M
The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects "Heidelberg standard examination" and "Heidelberg standard procedures", which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties.
SHIRIN HABIBI KHORASANI
Full Text Available Introduction: Medical student should be trained in medical ethics and one of the most essential issues in this field is taking informed consents. In this research, we compared the effect of effectiveness of teaching methods on students’ ability in taking informed consent from patients. Methods: This semi-experimental study was carried out on fifty eight subjects from the 4th-year students of Shiraz University of Medical Sciences who attended in medical ethics course before their ‘clinical clerkship’training.Method of sampling was census and students were randomly allocated into two groups of control group (n=28 was trained in traditional lecture-based class and the case groupnamed as A1 (n=22 were taught by video-taped examples of standardized patient.Then A1 group attended in traditional lecture-based classes named as A2. The groups were evaluated in terms the ability of recognition of ethical issues through the scenario based ethical examination before and after each training. Scenarios were related to the topics of informed consent. Data were analyzed by SPSS 14 software using descriptive statistics and anova test. P-value less than 0.05 was considered as significant. Results: The mean scores results of A2, A1 and B group were found to be 7.21, 5.91 and 5.73 out of 8, respectively. Comparison between the groups demonstrated that the ability of taking informed consent was significantly higher in A2 group (p<0.001, followed by A1 group (p<0.05, while was the least in the B group (p=0.875. Conclusion: According to this research, lecture-based teaching is still of great value in teaching medical ethics, but when combined with standardized patient, the outcome will be much better. It should be considered that mixed methods of teaching should be used together for better result.
Wen, Jia Rong; Shih, Wen Ling
The main purpose of this study was to establish Information Literacy Competence Standards for Elementary and High School Teachers. To establish these standards a set of two expert round-table discussions and three rounds of Delphi Technique surveys were employed. Ten participants including field scholars, information professionals were invited to…
Lee, Yung-Tsun Tina
This report documents a journey "from research to an approved standard" of a NIST-led standard development activity. That standard, Core Manufacturing Simulation Data (CMSD) information model, provides neutral structures for the efficient exchange of manufacturing data in a simulation environment. The model was standardized under the auspices of the international Simulation Interoperability Standards Organization (SISO). NIST started the research in 2001 and initiated the standardization effort in 2004. The CMSD standard was published in two SISO Products. In the first Product, the information model was defined in the Unified Modeling Language (UML) and published in 2010 as SISO-STD-008-2010. In the second Product, the information model was defined in Extensible Markup Language (XML) and published in 2013 as SISO-STD-008-01-2012. Both SISO-STD-008-2010 and SISO-STD-008-01-2012 are intended to be used together.
... Hotel, 2500 Calvert Street, NW., Washington, DC. The hotel telephone number is 202-234-0700. Contact... Clinical Operations, Clinical Quality, Privacy & Security Tiger Team, and Enrollment Workgroups. ONC...: Interested persons may present data, information, or views, [[Page 42091
Medeiros, Eliabe Rodrigues de; Silva, Sandy Yasmine Bezerra E; Ataide, Cáthia Alessandra Varela; Pinto, Erika Simone Galvão; Silva, Maria de Lourdes Costa da; Villa, Tereza Cristina Scatena
to analyze the clinical information systems used in the management of tuberculosis in Primary Health Care. descriptive, quantitative cross-sectional study with 100 health professionals with data collected through a questionnaire to assess local institutional capacity for the model of attention to chronic conditions, as adapted for tuberculosis care. The analysis was performed through descriptive and inferential statistics. Nurses and the Community Health Agents were classified as having fair capacity with a mean of 6.4 and 6.3, respectively. The city was classified as having fair capacity, with a mean of 6.0 and standard deviation of 1.5. Family Health Units had higher capacity than Basic Health Units and Mixed Units, although not statistically relevant. Clinical records and data on tuberculosis patients, items of the clinical information systems, had a higher classification than the other items, classified as having fair capacity, with a mean of 7.3 and standard deviation of 1.6, and the registry of TB patients had a mean of 6.6 and standard deviation of 2.0. clinical information systems are present in the city, mainly in clinical records and patient data, and they have the contribution of professionals linked with tuberculosis patients.
Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A
If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.
Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A
Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960
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.
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
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.
Yusrina, Hasyyati; Mukhtaruddin, Mukhtaruddin; Fuadah, Luk Luk; Sulong, Zunaidah
The International Financial Reporting Standards (IFRS) initiated by International Accounting Standard Board (IASB) are principle-based standard that require extensive disclosure of financial statements and accounting information as compared to prior standard that is the Generally Accepted Accounting Principles (GAAP) to better reflect the overall quality of company’s performance. Therefore, the IFRS convergence is expected to improve the reliability of financial reporting by limiting opportun...
Hellsten, Erik; Chu, Scally; Crump, R Trafford; Yu, Kevin; Sutherland, Jason M
Develop pricing models for bundled payments that draw inputs from clinician-defined best practice standards and benchmarks set from regional variations in utilization. Health care utilization and claims data for a cohort of incident Ontario ischemic and hemorrhagic stroke episodes. Episodes of care are created by linking incident stroke hospitalizations with subsequent health service utilization across multiple datasets. Costs are estimated for episodes of care and constituent service components using setting-specific case mix methodologies and provincial fee schedules. Costs are estimated for five areas of potentially avoidable utilization, derived from best practice standards set by an expert panel of stroke clinicians. Alternative approaches for setting normative prices for stroke episodes are developed using measures of potentially avoidable utilization and benchmarks established by the best performing regions. There are wide regional variations in the utilization of different health services within episodes of stroke care. Reconciling the best practice standards with regional utilization identifies significant amounts of potentially avoidable utilization. Normative pricing models for stroke episodes result in increasingly aggressive redistributions of funding. Bundled payment pilots to date have been based on the costs of historical service patterns, which effectively 'bake in' unwarranted and inefficient variations in utilization. This study demonstrates the feasibility of novel clinically informed episode pricing approaches that leverage these variations to target reductions in potentially avoidable utilization. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Armstrong, Kirk J.; Jarriel, Amanda J.
Context: Providing students reliable objective feedback regarding their clinical performance is of great value for ongoing clinical skill assessment. Since a standardized patient (SP) is trained to consistently portray the case, students can be assessed and receive immediate feedback within the same clinical encounter; however, no research, to our…
Agoritsas, T; Perneger, T V
There is growing evidence that the quality of informed consent in clinical research is often sub-optimal. To explore the conformity of patient recruitment with recommended informed consent procedures among patients who were invited to participate in a clinical study at a general teaching hospital, and to examine the association between consent procedures and the patients' decision to participate. All inpatients discharged during a 1-month period were invited to complete a mailed survey in which they reported whether they were invited to participate in a study and whether 13 recommended elements of informed consent actually occurred. Among 1303 respondents, 265 (20.3%) reported that they had been invited to participate in a study, and 191 (72.1%) accepted. While the majority of potential participants were fully informed about practical issues related to the study (e.g. what their participation would consist in), informed of possible risks or benefits, and only 20% about the origin of the study funds. Only 60% reported satisfactory answers to items assessing the overall information process (e.g. explanations were easy to understand). Older and sicker patients reported lower levels of conformity with informed consent procedures, as did patients who refused to participate in a study. Our results confirm that informed consent procedures fail to meet standards for many patients. In particular, consent information should be adapted to the needs of older and sicker patients. Improving the quality of informed consent may increase patients' participation in clinical research.
Percivall, G. S.; Arctur, D. K.
Increasingly, Earth science research must make effective use of interdisciplinary data sources and processes. Non-interoperability impedes sharing of data and computing resources. Standards from the Open Geospatial Consortium (OGC) and other organizations are the basis for successfully deploying a seamless, distributed information infrastructure for the geosciences. Collaborative development of the standards has proven effective in reducing barriers to standards adoption. Standards are the basis for the success of the Internet and the World Wide Web. A standard describes a set of rules that have been agreed to in some consensus forum, such as the Internet Engineering Task Force (IETF), the International Organization for Standardization (ISO), or the OGC. As described in The Importance of Going Open, “non-interoperability causes organizations to spend much more than necessary on geospatial information technology development”. In the context of e-Science, the National Science Foundation’s Cyberinfrastructure Council argues that “The use of standards creates economies of scale and scope for developing and deploying common resources, tools, software, and services that enhance the use of cyberinfrastructure in multiple science and engineering communities.” Barriers to adoption include misperceptions and misuse of standards. “Adhering to standards costs more” - typically this statement is made when a research program considers implementing standards as a one-time modification to an existing system. Multiple economic studies have shown lower development costs when using standards over the life of a project. “Standards stifle innovation” - a key decision in research is to consider what assumptions to consider fixed and what to challenge. The long history of standards in research, e.g., SI units, is fundamental to assessing repeatable results by independent researchers. Similar need for common standards exist in the information systems used for Earth
Wyatt, J. C.
On 12 July the Audit Commission published For Your Information, a well researched report about information and its management in acute hospitals in Britain, how and why it is failing, and steps that clinicians, managers, and the NHS should take to correct this. This article discusses why information management matters to clinicians and considers the problems identified by the Audit Commission--most of which will strike chords with doctors--and possible remedies. Finally, it describes possible routes to administer these remedies and the proposal, recently supported by the BMA Council, for a national centre for health informatics with the goals of educating and enthusing clinicians about informatics, empowering them to participate in local and national information management decisions; exploring how information can be used to improve patient care and outcomes; and evaluating clinical information systems and helping to realise their benefits. PMID:7613433
Full Text Available Topic maps are an ISO standard (ISO 13250 that is used for presenting the information about information resources structures. The initial idea of this standard was raised in 1991 and due to its strength; it turned into an ISO standard. This paper investigates concepts and model of topic maps and aims to mention applications of this standard in library and information science (LIS realm. A topic map, as a type of document is defined as XML or SGML technically. Research show that this standard is compatible with some of LIS techniques and rules especially in knowledge organization, but it attempts to use these rules in the web. So it can be said that according to some challenges that LIS field faces in adapting traditional techniques for knowledge organization in the Web, topic maps standard can help in solving such problems and challenges and this is what some experts of LIS tried to do.
Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341
Rapport, Frances; Storey, Mel; Porter, Alison; Snooks, Helen; Jones, Kerina; Peconi, Julie; Sánchez, Antonio; Siebert, Stefan; Thorne, Kym; Clement, Clare; Russell, Ian
Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials.
Bhupathi, P Arun; Ravi, G R
Informed consent in research, clinical trial, and practice is a process in which a patient/participant consents to participate or undergo the proposed procedures after being informed of its procedures, risks, and benefits. Ideally, the patient/participant is expected to give his consent only after fully comprehending the information about the procedures, benefits, and risks involved in research/clinical trial/practice. Thus, many ethical issues are entwined in the process of obtaining a proper informed consent. Certain untoward events in the past led to propose guidelines to prevent exploitations and unhealthy practices in the field of life science. Eventually, the practice of obtaining informed consent was emphasized to make sure that a participant's rights were not in jeopardy. Yet, there are flaws in the practical application of obtaining consent due to lack of understanding, barriers in communication, culture, custom, and various other factors. The present article highlights the need for a complete and comprehensive format of recording informed consent without compromising the rights of an individual and the standards of research or practice on ethical and moral grounds. Bhupathi PA, Ravi GR. Comprehensive Format of Informed Consent in Research and Practice: A Tool to uphold the Ethical and Moral Standards. Int J Clin Pediatr Dent 2017;10(1):73-81.
Bouamrane, Matt-Mouley; Mair, Frances S
Establishing day-case surgery as the preferred hospital admission route for all eligible patients requires adequate preoperative assessment of patients in order to quickly distinguish those who will require minimum assessment and are suitable for day-case admission from those who will require more extensive management and will need to be admitted as inpatients. As part of a study to elucidate clinical and information management processes within the patient surgical pathway in NHS Scotland, we conducted a total of 10 in-depth semi-structured interviews during 4 visits to the Dumfries & Galloway Royal Infirmary surgical pre-assessment clinic. We modelled clinical processes using process-mapping techniques and analysed interview data using qualitative methods. We used Normalisation Process Theory as a conceptual framework to interpret the factors which were identified as facilitating or hindering information elucidation tasks and communication within the multi-disciplinary team. The pre-assessment clinic of Dumfries & Galloway Royal Infirmary was opened in 2008 in response to clinical and workflow issues which had been identified with former patient management practices in the surgical pathway. The preoperative clinic now operates under well established processes and protocols. The use of a computerised system for managing preoperative documentation substantially transformed clinical practices and facilitates communication and information-sharing among the multi-disciplinary team. Successful deployment and normalisation of innovative clinical and information management processes was possible because both local and national strategic priorities were synergistic and the system was developed collaboratively by the POA staff and the health-board IT team, resulting in a highly contextualised operationalisation of clinical and information management processes. Further concerted efforts from a range of stakeholders are required to fully integrate preoperative assessment
Farzandipour, Mehrdad; Jeddi, Fateme Rangraz; Gilasi, Hamid Reza; Shirzadi, Diana
infertility is referred to the person's inability to conceive pregnancy after one year of intercourse without using protection. This study paves the ground for creating a complete, united, and coherent source of patients' medical information. this is an applied research of descriptive-cross sectional type which has been carried out through qualitative - quantitative methods. The sample of the present study was 50 specialists in the field of infertility which has been chosen based on purposive sampling method. Designing the questionnaire was done based on library studies and Gathering experts' views was done based on Delphi technique. 261 items from clinical and Para clinical information of infertile patients' electronic health records were subjected to an opinion poll by experts. During this process 223 items were accepted and 38 items have been rejected after two sessions of surveys by infertility experts. Para clinical information section consisted of 57 items that all of them have been accepted by the experts. Also, clinical information section consisted of 242 items from which 204 items were accepted and 38 items were rejected by the experts. existence of a structured electronic record system of infertile patients' information leads to the integration of patients' information, improvement of health care services and a decrease in treatment costs: all working to increase information safety. Furthermore, only essential and relevant information would be provided for the specialists and it will facilitate and direct the future infertility related studies due to the coherence, unity and relevance of the information.
Gwak, Yeon Joo; Kim, Hye Jung; Kwak, Jin Young; Son, Eun Ju; Ko, Kyung Hee; Lee, Jin Hwa; Lim, Hyo Soon; Lee, You Jin; Park, Ji Won; Shin, Kyung Min; Jang, Yun-Jin
The goal of this study is to compare the overall quality of film mammograms taken according to the Korean standards with the American College of Radiology (ACR) standard for clinical image evaluation and to identify means of improving mammography quality in Korea. Four hundred and sixty eight sets of film mammograms were evaluated with respect to the Korean and ACR standards for clinical image evaluation. The pass and failure rates of mammograms were compared by medical facility types. Average scores in each category of the two standards were evaluated. Receiver operating characteristic curve analysis was used to identify an optimal Korean standard pass mark by taking the ACR standard as the reference standard. 93.6% (438/468) of mammograms passed the Korean standard, whereas only 80.1% (375/468) passed the ACR standard (p < 0.001). Non-radiologic private clinics had the lowest pass rate (88.1%: Korean standard, 71.8%: ACR standard) and the lowest total score (76.0) by the Korean standard. Average scores of positioning were lowest (19.3/29 by the Korean standard and 3.7/5 by the ACR standard). A cutoff score of 77.0 for the Korean standard was found to correspond to a pass level when the ACR standard was applied. We suggest that tighter regulations, such as, raising the Korean pass mark, subtracting more for severe deficiencies, or considering a very low scores in even a single category as failure, are needed to improve the quality of mammography in Korea
Devaux, B C; Roux, F X
From initial experiments of ruby, argon and CO2 lasers on the nervous system so far, dramatic progress was made in delivery systems technology as well as in knowledge of laser-tissue interaction effects and hazards through various animal experiments and clinical experience. Most surgical effects of laser light on neural tissue and the central nervous system (CNS) are thermal lesions. Haemostasis, cutting and vaporization depend on laser emission parameters--wavelength, fluence and mode--and on the exposed tissues optical and thermal properties--water and haemoglobin content, thermal conductivity and specific heat. CO2 and Nd-YAG lasers have today a large place in the neurosurgical armamentarium, while new laser sources such as high power diode lasers will have one in the near future. Current applications of these lasers derive from their respective characteristics, and include CNS tumour and vascular malformation surgery, and stereotactic neurosurgery. Intracranial, spinal cord and intra-orbital meningiomas are the best lesions for laser use for haemostasis, dissection and tissue vaporization. Resection of acoustic neuromas, pituitary tumours, spinal cord neuromas, intracerebral gliomas and metastases may also benefit from lasers as accurate, haemostatic, non-contact instruments which reduce surgical trauma to the brain and eloquent structures such as brain stem and cranial nerves. Coagulative lasers (1.06 microns and 1.32 microns Nd-YAG, argon, or diode laser) will find an application for arteriovenous malformations and cavernomas. Any fiberoptic-guided laser will find a use during stereotactic neurosurgical procedures, including image-guided resection of tumours and vascular malformations and endoscopic tumour resection and cysts or entry into a ventricle. Besides these routine applications of lasers, laser interstitial thermotherapy (LITT) and photodynamic therapy (PDT) of brain tumours are still in the experimental stage. The choice of a laser in a
... Relationships Risk Management Principles,” Nov. 1, 2001; FDIC FIL 68-99, Risk Assessment Tools and Practices for... investigation, can determine from its logs or other data precisely which customers' information has been.... Standards for Safeguarding Customer Information A. Information Security Program B. Objectives III...
Wombacher, Andreas; Aberer, K.
Automatizing information commerce requires languages to represent the typical information commerce processes. Existing languages and standards cover either only very specific types of business models or are too general to capture in a concise way the specific properties of information commerce
... Part III Department of Health and Human Services 45 CFR Part 170 Health Information Technology... Secretary 45 CFR Part 170 RIN 0991-AB58 Health Information Technology: Initial Set of Standards... of the National Coordinator for Health Information Technology (ONC), Department of Health and Human...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Information Technology Standards Committee Advisory Meeting: Notice of Meeting AGENCY: Office of the National Coordinator for Health Information Technology... committee of the Office of the National Coordinator for Health Information Technology (ONC). These meeting...
... information technology? 542.16 Section 542.16 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE... standards for information technology? Link to an amendment published at 73 FR 60498, Oct. 10, 2008. This... adequately segregated and monitored to prevent error in general information technology procedures to go...
... Part III Department of Health and Human Services 45 CFR Part 170 Health Information Technology... Secretary 45 CFR Part 170 RIN 0991-AB58 Health Information Technology: Initial Set of Standards... of the National Coordinator for Health Information Technology, Department of Health and Human...
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 of peer-reviewed articles. Data extraction: Online searches were done and requests for reprints from corresponding ...
Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)
Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J.
Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. PMID:26188274
Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).
Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J
Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.
Full Text Available As points of interest (POIon the internet, exists widely incomplete addresses and inconsistent literal expressions, a fast standardization processing method of network POIs address information based on spatial constraints was proposed. Based on the model of the extensible address expression, first of all, address information of POI was segmented and extracted. Address elements are updated by means of matching with the address tree layer by layer. Then, by defining four types of positional relations, corresponding set are selected from standard POI library as candidate for enrichment and amendment of non-standard address. At last, the fast standardized processing of POI address information was achieved with the help of backtracking address elements with minimum granularity. Experiments in this paper proved that the standardization processing of an address can be realized by means of this method with higher accuracy in order to build the address database.
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 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 information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a "reasonable" patient's standard is to be met.
... Social Security Administration published a document in the Federal Register of September 18, 2013... SOCIAL SECURITY ADMINISTRATION [Docket No. SSA-2012-0026] Charging Standard Administrative Fees for Nonprogram-Related Information; Correction AGENCY: Social Security Administration. ACTION: Notice...
Barwise, Amelia; Caples, Sean; Jensen, Jeffrey; Pickering, Brian; Herasevich, Vitaly
Information overload in healthcare is dangerous. It can lead to critical errors and delays. During Rapid Response Team (RRT) activations providers must make decisions quickly to rescue patients from physiological deterioration. In order to understand the clinical data required and how best to present that information in electronic systems we aimed to better assess the data needs of providers on the RRT when they respond to an event. A web based survey to evaluate clinical data requirements was created and distributed to all RRT providers at our institution. Participants were asked to rate the importance of each data item in guiding clinical decisions during a RRT event response. There were 96 surveys completed (24.5% response rate) with fairly even distribution throughout all clinical roles on the RRT. Physiological data including heart rate, respiratory rate, and blood pressure were ranked by more than 80% of responders as being critical information. Resuscitation status was also considered critically useful by more than 85% of providers. There is a limited dataset that is considered important during an RRT. The data is widely available in EMR. The findings from this study could be used to improve user-centered EMR interfaces.
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.
Chen, Elizabeth S; Melton, Genevieve B; Engelstad, Mark E; Sarkar, Indra Neil
The standardization of clinical document names is an essential first step towards the optimal use, management, and exchange of documents within and across institutions. The HL7/LOINC Document Ontology (DO) is an existing and evolving document standard developed to provide consistent naming of clinical documents and to guide the creation of LOINC codes for clinical notes. The goal of this study was to explore the feasibility and challenges of mapping local clinical document names from two institutions into the five axes of the DO and then to leverage this mapping for identifying specific LOINC codes. The results indicate that the DO is either adequate or too broad for representing a majority of the document names and that there are LOINC codes available for one- to two-thirds of the names. Through this mapping process, granularity and other issues were revealed that will be valuable for guiding next steps towards effective standardization of clinical document names.
Hill, Anne E.; Davidson, Bronwyn J.; Theodoros, Deborah G.
Background: Standardized patients (SPs) are frequently included in the clinical preparation of students in the health sciences. An acknowledged benefit of using SPs is the opportunity to provide a standardized method by which students can demonstrate and develop their competency. Relatively little is known, however, about the capacity of SPs to…
Monteith, Brian D.
Three principles of classification are stressed in the development of electronic dental patient records and clinical databases: (1) the classification must have a suitable organizing principle; (2) use must be made of standard terminology; and (3) there must be standard operational criteria. (DB)
... AFFAIRS Agency Information Collection (Application for Standard Government Headstone or Marker for..., OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC... for Standard Government Headstone or Marker for Installation in a Private or State Veterans' Cemetery...
Lucena Filho, José Hardman Sátiro de; Lima, Rennaly de Freitas; Medeiros, Ana Claudia Dantas de; Pereira, Jozinete Vieira; Granville-Garcia, Ana Flávia; Costa, Edja Maria Melo de Brito
The aim of the present study was to evaluate the antibacterial and antifungal potential in vitro of Momordica charantia L. against the microorganisms of clinical interest (standard strains and multiresistant isolates) in order to aggregate scientific information in relation to its use as a therapeutic product. M. charantia L. plant material was acquired in municipality of Malta, Paraiba, Brazil. The extract was obtained through maceration, filtration and then concentrated under reduced pressure in a rotary evaporator, resulting in a dough, and was then dried in an oven for 72 hours at 40°C. Antimicrobial action of ethanolic extract of seed M. charantia L. was evaluated based on the minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC) and minimum fungicidal concentration (MFC) against standard strains of bacteria, isolates multiresistant bacteria and Candida species, by microdilution in broth method. All organisms were sensitive to the extract, being considered strong antimicrobial activity (MIC and MBC/MFC charantia L. showed strong antimicrobial potential, with bactericidal and fungicidal profile, there is the prospect to constitute a new therapeutic strategy for the control of infections, particularly in multiresistant strains. The use of medicinal plants in treatment of infectious processes have an important function nowadays, due to the limitations of the use of synthetic antibiotics available, related specifically to the microbial resistance emergence.
Callender, E. David; Steinbacher, Jody
This is the third of five volumes on Information System Life-Cycle and Documentation Standards which present a well organized, easily used standard for providing technical information needed for developing information systems, components, and related processes. This volume states the Software Management and Assurance Program documentation standard for a product specification document and for data item descriptions. The framework can be applied to any NASA information system, software, hardware, operational procedures components, and related processes.
Flaxman Abraham D
Full Text Available Abstract Background Physician review of a verbal autopsy (VA and completion of a death certificate remains the most widely used approach for VA analysis. This study provides new evidence about the performance of physician-certified verbal autopsy (PCVA using defined clinical diagnostic criteria as a gold standard for a multisite sample of 12,542 VAs. The study was also designed to analyze issues related to PCVA, such as the impact of a second physician reader on the cause of death assigned, the variation in performance with and without household recall of health care experience (HCE, and the importance of local information for physicians reading VAs. Methods The certification was performed by 24 physicians. The assignment of VA was random and blinded. Each VA was certified by one physician. Half of the VAs were reviewed by a different physician with household recall of health care experience included. The completed death certificate was processed for automated ICD-10 coding of the underlying cause of death. PCVA was compared to gold standard cause of death assignment based on strictly defined clinical diagnostic criteria that are part of the Population Health Metrics Research Consortium (PHMRC gold standard verbal autopsy study. Results For individual cause assignment, the overall chance-corrected concordance for PCVA against the gold standard cause of death is less than 50%, with substantial variability by cause and physician. Physicians assign the correct cause around 30% of the time without HCE, and addition of HCE improves performance in adults to 45% and slightly higher in children to 48%. Physicians estimate cause-specific mortality fractions (CSMFs with considerable error for adults, children, and neonates. Only for neonates for a cause list of six causes with HCE is accuracy above 0.7. In all three age groups, CSMF accuracy improves when household recall of health care experience is available. Conclusions Results show that physician
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.
Full Text Available Abstract Background In Britain over 39,000 reports were received by the National Patient Safety Agency relating to failures in documentation in 2007 and the UK Health Services Journal estimated in 2008 that over a million hospital outpatient visits each year might take place without the full record available. Despite these high numbers, the impact of missing clinical information has not been investigated for hospital outpatients in the UK. Studies in primary care in the USA have found 13.6% of patient consultations have missing clinical information, with this adversely affecting care in about half of cases, and in Australia 1.8% of medical errors were found to be due to the unavailability of clinical information. Our objectives were to assess the frequency, nature and potential impact on patient care of missing clinical information in NHS hospital outpatients and to assess the principal causes. This is the first study to present such figures for the UK and the first to look at how clinicians respond, including the associated impact on patient care. Methods Prospective descriptive study of missing information reported by surgeons, supplemented by interviews on the causes. Data were collected by surgeons in general, gastrointestinal, colorectal and vascular surgical clinics in three teaching hospitals across the UK for over a thousand outpatient appointments. Fifteen interviews were conducted with those involved in collating clinical information for these clinics. The study had ethics approval (Hammersmith and Queen Charlotte's & Chelsea Research Ethics Committee, reference number (09/H0707/27. Participants involved in the interviews signed a consent form and were offered the opportunity to review and agree the transcript of their interview before analysis. No patients were involved in this research. Results In 15% of outpatient consultations key items of clinical information were missing. Of these patients, 32% experienced a delay or disruption
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 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.
Provision of a draft version for standard classification structure for information of radiation technologies through analyzing their information and derivation of its applicable requirements to the information system
Jang, Sol Ah; Kim, Joo Yeon; Yoo, Ji Yup; Shin, Woo Ho; Park, Tai Jin; Song, Myung Jae [Korean Association for Radiation Application, Seoul (Korea, Republic of)
Radiation technology is the one for developing new products or processes by applying radiation or for creating new functions in industry, research and medical fields, and its application is increasing consistently. For securing an advanced technology competitiveness, it is required to create a new added value by information consumer through providing an efficient system for supporting information, which is the infrastructure for research and development, contributed to its collection, analysis and use with a rapidity and structure in addition to some direct research and development. Provision of the management structure for information resources is especially crucial for efficient operating the system for supporting information in radiation technology, and then a standard classification structure of information must be first developed as the system for supporting information will be constructed. The standard classification structure has been analyzed by reviewing the definition of information resources in radiation technology, and those classification structures in similar systems operated by institute in radiation and other scientific fields. And, a draft version of the standard classification structure has been then provided as 7 large, 25 medium and 71 small classifications, respectively. The standard classification structure in radiation technology will be developed in 2015 through reviewing this draft version and experts' opinion. Finally, developed classification structure will be applied to the system for supporting information by considering the plan for constructing this system and database, and requirements for designing the system. Furthermore, this structure will be designed in the system for searching information by working to the individual need of information consumers.
Provision of a draft version for standard classification structure for information of radiation technologies through analyzing their information and derivation of its applicable requirements to the information system
Jang, Sol Ah; Kim, Joo Yeon; Yoo, Ji Yup; Shin, Woo Ho; Park, Tai Jin; Song, Myung Jae
Radiation technology is the one for developing new products or processes by applying radiation or for creating new functions in industry, research and medical fields, and its application is increasing consistently. For securing an advanced technology competitiveness, it is required to create a new added value by information consumer through providing an efficient system for supporting information, which is the infrastructure for research and development, contributed to its collection, analysis and use with a rapidity and structure in addition to some direct research and development. Provision of the management structure for information resources is especially crucial for efficient operating the system for supporting information in radiation technology, and then a standard classification structure of information must be first developed as the system for supporting information will be constructed. The standard classification structure has been analyzed by reviewing the definition of information resources in radiation technology, and those classification structures in similar systems operated by institute in radiation and other scientific fields. And, a draft version of the standard classification structure has been then provided as 7 large, 25 medium and 71 small classifications, respectively. The standard classification structure in radiation technology will be developed in 2015 through reviewing this draft version and experts' opinion. Finally, developed classification structure will be applied to the system for supporting information by considering the plan for constructing this system and database, and requirements for designing the system. Furthermore, this structure will be designed in the system for searching information by working to the individual need of information consumers
Sporer, Matthias E; Mathy, Joanna E; Kenealy, John; Mathy, Jon A
INTRODUCTION For general practitioners, practice nurses and community pharmacists in New Zealand, a core duty is to educate patients about sun protection. We aimed to evaluate compliance of locally available sunscreens with regional clinical practice guidelines and sunscreen labelling standards, to assist clinicians in advising consumers on sunscreen selection. METHODS We audited all sunscreens available at two Auckland stores for three New Zealand sunscreen retailers. We then assessed compliance with accepted regional clinical practice guidelines for sun protection from the New Zealand Guidelines Group. We further assessed compliance with regional Australia/New Zealand consumer standards for sunscreen labelling. RESULTS All sunscreens satisfied clinical guidelines for broad-spectrum protection, and 99% of sunscreens met or exceeded clinical guidelines for minimal Sun Protection Factor. Compliance with regional standardized labelling guidelines is voluntary in New Zealand and 27% of audited sunscreens were not fully compliant with SPF labelling standards. DISCUSSION Sunscreens were generally compliant with clinical guidelines for minimal sun protection. However there was substantial noncompliance with regional recommendations for standardized sunscreen labelling. Primary health care clinicians should be aware that this labelling noncompliance may mislead patients into thinking some sunscreens offer more sun protection than they do. Mandatory compliance with the latest regional labelling standards would simplify sunscreen selection by New Zealand consumers. KEYWORDS Sunscreen; Sun Protection Factor; SPF; Skin Neoplasms; Melanoma; Skin Cancer Prevention.
Oronoz, Maite; Gojenola, Koldo; Pérez, Alicia; de Ilarraza, Arantza Díaz; Casillas, Arantza
The advances achieved in Natural Language Processing make it possible to automatically mine information from electronically created documents. Many Natural Language Processing methods that extract information from texts make use of annotated corpora, but these are scarce in the clinical domain due to legal and ethical issues. In this paper we present the creation of the IxaMed-GS gold standard composed of real electronic health records written in Spanish and manually annotated by experts in pharmacology and pharmacovigilance. The experts mainly annotated entities related to diseases and drugs, but also relationships between entities indicating adverse drug reaction events. To help the experts in the annotation task, we adapted a general corpus linguistic analyzer to the medical domain. The quality of the annotation process in the IxaMed-GS corpus has been assessed by measuring the inter-annotator agreement, which was 90.53% for entities and 82.86% for events. In addition, the corpus has been used for the automatic extraction of adverse drug reaction events using machine learning. Copyright © 2015 Elsevier Inc. All rights reserved.
Murray, Elizabeth; McAdam, Rodney
This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.
Ohmann, Christian; Kuchinke, Wolfgang; Canham, Steve
A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre......). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed...... a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials....
Danon, Y L; Saiag, E
Over the last 5 years Israel has implemented a nationwide health insurance plan covering the entire population of the country. We have developed a clinical information system based on electronic-chip health care medical smart cards. Health care cards are used in several European countries and chip smart cards have been successful in many sectors. Our project involves the community use of the MSC, thereby enabling health care professionals to skillfully employ card systems in the health care sector. This system can easily arrange electronic medical charts in clinics, facilitating the confidential sharing of personal health databases among health professionals. To develop an MSC applicable for daily use in the community and hospital system. The MSC project, currently underway in Israel and the USA, will aid in determining the costs, benefits and feasibility of the MSC. Successful implementation of the MSC in chosen clinics will promote a nationwide willingness to adopt this promising technology.
Bailit, Howard L; Devitto, Judy; Myne-Joslin, Ronnie; Beazoglou, Tryfon; McGowan, Taegan
Federally Qualified Health Center (FQHC) dental clinics are a major component of the dental safety net system, providing care to 3.75 million patients annually. This study describes the financial and clinical operations of a sample of FQHCs. In cooperation with the National Network for Oral Health Access, FQHC dental clinics that could provide 12 months of electronic dental record information were asked to participate in the study. Based on data from 28 dental clinics (14 FQHCs), 50 percent of patients were under 21 years of age. The primary payers were Medicaid (72.4 percent) and sliding-scale/self-pay patients (17.5 percent). Sites averaged 3.1 operatories, 0.66 dental hygienists, and 1.9 other staff per dentist. Annually, each FTE dentist and hygienist provided 2,801 and 2,073 patient visits, respectively. Eighty percent of services were diagnostic, preventive, and restorative. Patient care accounted for 82 percent of revenues, and personnel (64.2 percent) and central administration (13.4 percent) accounted for most expenses. Based on a small convenience sample of FQHC dental clinics, this study presents descriptive data on their clinical and financial operations. Compared with data from the UDS (Uniform Data System) report, study FQHCs were larger in terms of space, staff, and patients served. However, there was substantial variation among clinics for almost all measures. As the number and size of FQHC dental clinics increase, the Health Resources and Services Administration needs to provide them access to comparative data that they can use to benchmark their operations. © 2013 American Association of Public Health Dentistry.
Dolatabadi Nasrin Davari
Full Text Available In this paper the state of health information system in US investigated to reach an instance for developing countries. Our main concern was to obtain how HIS and HIT help to increase public and especially elderly health. We do this investigation to setup standard bound to use in developing countries. HIS and HIT transit a mismanaged paper structure of record keeping to an efficient electronic database for record keeping. It will transform the method of management of data to ensure better information results for overall quality improvement. Health information System professionals also play pivotal role information interoperability. Information interoperability helps in easy transfer of data wherever it is needed. Information interoperability is essentially a function of hospitals, but the role played by HIS professionals makes them a good choice for interoperability developers in healthcare.
... provided in the desired format, reporting burden (time and financial resources) is minimized, collection... Extension of Existing Information Collection; Safety Standards for Roof Bolts in Metal and Nonmetal Mines... agencies with an opportunity to comment on proposed and continuing collections of information in accordance...
... information in accordance with the Paperwork Reduction Act of 1995. This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is... Extension of Existing Information Collection; Health Standards for Diesel Particulate Matter Exposure...
... OFFICE OF PERSONNEL MANAGEMENT Submission for Renewal: New Information Collection, Fingerprint... Fingerprint Chart Standard Form 87 (SF 87). As required by the Paperwork Reduction Act of 1995, (Pub. L. 104... [email protected] . SUPPLEMENTARY INFORMATION: The SF 87 is a fingerprint card, which is utilized to...
Park, Bum Jin; Jeong, Jae Ho; Son, Gi Gyeong Son; Kang, Hee Doo; Yoo, Beong Gyu; Lee, Jong Seok
The medical imaging issuance is changed from conventional film method to Digital Compact Disk solution because of development on IT technology. However other medical record department's are undergoing identification check through and through whereas medical imaging department cannot afford to do that. So, we examine present applicant's recognition of private intelligence safeguard, and medical imaging issuance condition by CD and DVD medium toward various medical facility and then perform comparative analysis associated with domestic and foreign law and recommendation, lastly suggest standard for medical imaging issuance and process relate with internal environment. First, we surveyed issuance process and required documents when situation of medical image issuance in the metropolitan medical facility by wire telephone between 2008.6.-12008.7.1. in accordance with the medical law Article 21clause 2, suggested standard through applicant's required documents occasionally - (1) in the event of oneself verifying identification, (2) in the event of family verifying applicant identification and family relations document (health insurance card, attested copy, and so on), (3) third person or representative verifying applicant identification and letter of attorney and certificate of one's seal impression. Second, also checked required documents of applicant in accordance with upper standard when situation of medical image issuance in Kyung-hee university medical center during 3 month 2008.5.-12008.7.31. Third, developed a work process by triangular position of issuance procedure for situation when verifying required documents and management of unpreparedness. Look all over the our manufactured output in the hospital - satisfy the all conditions 4 place(12%), possibly request everyone 4 place(12%), and apply in the clinic section 9 place(27%) that does not medical imaging issuance office, so we don't know about required documents condition. and look into whether meet or not
Taylor, Arthur; Dalal, Heather A.
Introduction: This paper aims to determine how appropriate information literacy instruction is for preparing students for these unmediated searches using commercial search engines and the Web. Method. A survey was designed using the 2000 Association of College and Research Libraries literacy competency standards for higher education. Survey…
Ellysa Stern Cahoy
Full Text Available Abstract: The first PA Forward Information Literacy Summit was held in State College at the Pennsylvania State University, University Park campus, on Wednesday, July 24, 2013. This summit brought together K-12 and academic librarians from Pennsylvania to discuss current issues in information literacy. This text is a transcript of a discussion between Ellysa Cahoy, past chair of the of the ACRL Information Literacy Competency Standards Committee, and the ACRL Information Literacy Competency Standards Review Task Force, and Craig Gibson and Trudi Jacobson who are currently co-chairs of the ACRL Information Literacy Standards Revision Task Force. This Task Force is charged with reviewing and revising the current ACRL Information Literacy Competency Standards for Higher Education, that were originally adopted by ACRL in 2000. This discussion was about the process by which the Standards came to be under review, some of the issues involved in the review, and the time line for the review and librarian feedback and comment on the process. The PowerPoint presentation which accompanied this discussion, as well as other documents mentioned during the presentation are attached to this transcript as supplemental files.
Partovi, S; Jacobi, B; Rapps, N; Zipp, L; Karimi, S; Rengier, F; Lyo, J K; Stippich, C
Brain tumors affecting language-relevant areas may influence language lateralization. The purpose of this study was to systematically investigate language lateralization in brain tumor patients using clinical language fMRI, comparing the results with a group of healthy volunteers. Fifty-seven strictly right-handed patients with left-hemispheric-space intracranial masses (mainly neoplastic) affecting either the Broca area (n = 19) or Wernicke area (n = 38) were prospectively enrolled in this study. Fourteen healthy volunteers served as a control group. Standardized clinical language fMRI, using visually triggered sentence- and word-generation paradigms, was performed on a 1.5T MR scanner. Semiautomated analyses of all functional data were conducted on an individual basis using BrainVoyager. A regional lateralization index was calculated for Broca and Wernicke areas separately versus their corresponding right-hemisphere homologs. In masses affecting the Broca area, a significant decrease in the lateralization index was found when performing word generation (P = .0017), whereas when applying sentence generation, the decrease did not reach statistical significance (P = .851). Masses affecting the Wernicke area induced a significant decrease of the lateralization index when performing sentence generation (P = .0007), whereas when applying word generation, the decrease was not statistically significant (P = .310). Clinical language fMRI was feasible for patients with brain tumors and provided relevant presurgical information by localizing essential language areas and determining language dominance. A significant effect of the brain masses on language lateralization was observed, with a shift toward the contralesional, nondominant hemisphere. This may reflect compensatory mechanisms of the brain to maintain communicative abilities.
Lee, Sung Hoon; Choe, Yeon Hyeon; Chung, Soo Young
The purpose of this study was to establish a quality standard for mammographic equipment Korea and to eventually improve mammographic quality in clinics and hospitals throughout Korea by educating technicians and clinic personnel. For the phantom test and on site assessment, we visited 37 sites and examined 43 sets of mammographic equipment. Items that were examined include phantom test, radiation dose measurement, developer assessment, etc. The phantom images were assessed visually and by optical density measurements. For the clinical image assessment, clinical images from 371 sites were examined following the new Korean standard for clinical image evaluation. The items examined include labeling, positioning, contrast, exposure, artifacts, collimation among others. Quality standard of mammographic equipment was satisfied in all equipment on site visits. Average mean glandular dose was 114.9 mRad. All phantom image test scores were over 10 points (average, 10.8 points). However, optical density measurements were below 1.2 in 9 sets of equipment (20.9%). Clinical image evaluation revealed appropriate image quality in 83.5%, while images from non-radiologist clinics were adequate in 74.6% (91/122), which was the lowest score of any group. Images were satisfactory in 59.0% (219/371) based on evaluation by specialists following the new Korean standard for clinical image evaluation. Satisfactory images had a mean score of 81.7 (1 S.D. =8.9) and unsatisfactory images had a mean score of 61.9 (1 S.D = 11). The correlation coefficient between the two observers was 0.93 (ρ < 0.01) in 49 consecutive cases. The results of the phantom tests suggest that optical density measurements should be performed as part of a new quality standard for mammographic equipment. The new clinical evaluation criteria that was used in this study can be implemented with some modifications for future mammography quality control by the Korean government
Natalia G. Miloslavskaya
Full Text Available The rapid progress in the filed of information security (IS puts one in a need of periodic revision of professional competencies (formulated in the federal state educational standards –FSESs and working functions (formulated in the professional standards – PSs. Under these conditions, a timely reaction to everything new that emerges or will appear in modern regulatory documents (primarily in standards is extremely important. We make a forecast for the content of the ISO/IEC 27021 and ISO/IEC 19896 standards drafted by the International Organization for Standardization (ISO, which should contain the requirements for the competencies of IS management system professionals and the competence of IS testers and evaluators. Our forecast takes into account the requirements of the ISO/IEC 27000 standard group and the recommendations of the European e-Competence Framework e-CF 3.0.
Jiang, Guoqian; Evans, Julie; Endle, Cory M; Solbrig, Harold R; Chute, Christopher G
The Biomedical Research Integrated Domain Group (BRIDG) model is a formal domain analysis model for protocol-driven biomedical research, and serves as a semantic foundation for application and message development in the standards developing organizations (SDOs). The increasing sophistication and complexity of the BRIDG model requires new approaches to the management and utilization of the underlying semantics to harmonize domain-specific standards. The objective of this study is to develop and evaluate a Semantic Web-based approach that integrates the BRIDG model with ISO 21090 data types to generate domain-specific templates to support clinical study metadata standards development. We developed a template generation and visualization system based on an open source Resource Description Framework (RDF) store backend, a SmartGWT-based web user interface, and a "mind map" based tool for the visualization of generated domain-specific templates. We also developed a RESTful Web Service informed by the Clinical Information Modeling Initiative (CIMI) reference model for access to the generated domain-specific templates. A preliminary usability study is performed and all reviewers (n = 3) had very positive responses for the evaluation questions in terms of the usability and the capability of meeting the system requirements (with the average score of 4.6). Semantic Web technologies provide a scalable infrastructure and have great potential to enable computable semantic interoperability of models in the intersection of health care and clinical research.
Chaplin-Kramer, Rebecca; Jonell, Malin; Guerry, Anne; Lambin, Eric F; Morgan, Alexis J; Pennington, Derric; Smith, Nathan; Franch, Jane Atkins; Polasky, Stephen
The growing base of information about ecosystem services generated by ecologists, economists, and other scientists could improve the implementation, monitoring, and evaluation of commodity-sourcing standards being adopted by corporations to mitigate risk in their supply chains and achieve sustainability goals. This review examines various ways that information about ecosystem services could facilitate compliance with and auditing of commodity-sourcing standards. We also identify gaps in the current state of knowledge on the ecological effectiveness of sustainability standards and demonstrate how ecosystem-service information could complement existing monitoring efforts to build credible evidence. This paper is a call to the ecosystem-service scientists to engage in this decision context and tailor the information they are generating to the needs of the standards community, which we argue would offer greater efficiency of standards implementation for producers and enhanced effectiveness for standard scheme owners and corporations, and should thus lead to more sustainable outcomes for people and nature. © 2015 New York Academy of Sciences.
Kagan, Jonathan M; Gupta, Nitin; Varghese, Suresh; Virkar, Hemant
The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) Enterprise Information System (DAIDS-ES) is a web-based system that supports NIAID in the scientific, strategic, and tactical management of its global clinical research programs for HIV/AIDS vaccines, prevention, and therapeutics. Different from most commercial clinical trials information systems, which are typically protocol-driven, the DAIDS-ES was built to exchange information with those types of systems and integrate it in ways that help scientific program directors lead the research effort and keep pace with the complex and ever-changing global HIV/AIDS pandemic. Whereas commercially available clinical trials support systems are not usually disease-focused, DAIDS-ES was specifically designed to capture and incorporate unique scientific, demographic, and logistical aspects of HIV/AIDS treatment, prevention, and vaccine research in order to provide a rich source of information to guide informed decision-making. Sharing data across its internal components and with external systems, using defined vocabularies, open standards and flexible interfaces, the DAIDS-ES enables NIAID, its global collaborators and stakeholders, access to timely, quality information about NIAID-supported clinical trials which is utilized to: (1) analyze the research portfolio, assess capacity, identify opportunities, and avoid redundancies; (2) help support study safety, quality, ethics, and regulatory compliance; (3) conduct evidence-based policy analysis and business process re-engineering for improved efficiency. This report summarizes how the DAIDS-ES was conceptualized, how it differs from typical clinical trial support systems, the rationale for key design choices, and examples of how it is being used to advance the efficiency and effectiveness of NIAID's HIV/AIDS clinical research programs.
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
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
... Hotel, 2500 Calvert Street, NW., Washington, DC. The hotel telephone number is 202-234-0700. Contact... Clinical Operations, Clinical Quality, Privacy & Security, and Implementation Workgroups. ONC intends to... persons may present data, information, or views, orally or in writing, on issues pending before the...
... Hotel, 2500 Calvert Street, NW., Washington, DC. The hotel telephone number is 202-234-0700. Contact... Clinical Operations, Clinical Quality, Privacy & Security, and Implementation Workgroups. ONC intends to...: Interested persons may present data, information, or views, orally or in writing, on issues pending before...
Becnel, Lauren B; Hastak, Smita; Ver Hoef, Wendy; Milius, Robert P; Slack, MaryAnn; Wold, Diane; Glickman, Michael L; Brodsky, Boris; Jaffe, Charles; Kush, Rebecca; Helton, Edward
It is critical to integrate and analyze data from biological, translational, and clinical studies with data from health systems; however, electronic artifacts are stored in thousands of disparate systems that are often unable to readily exchange data. To facilitate meaningful data exchange, a model that presents a common understanding of biomedical research concepts and their relationships with health care semantics is required. The Biomedical Research Integrated Domain Group (BRIDG) domain information model fulfills this need. Software systems created from BRIDG have shared meaning "baked in," enabling interoperability among disparate systems. For nearly 10 years, the Clinical Data Standards Interchange Consortium, the National Cancer Institute, the US Food and Drug Administration, and Health Level 7 International have been key stakeholders in developing BRIDG. BRIDG is an open-source Unified Modeling Language-class model developed through use cases and harmonization with other models. With its 4+ releases, BRIDG includes clinical and now translational research concepts in its Common, Protocol Representation, Study Conduct, Adverse Events, Regulatory, Statistical Analysis, Experiment, Biospecimen, and Molecular Biology subdomains. The model is a Clinical Data Standards Interchange Consortium, Health Level 7 International, and International Standards Organization standard that has been utilized in national and international standards-based software development projects. It will continue to mature and evolve in the areas of clinical imaging, pathology, ontology, and vocabulary support. BRIDG 4.1.1 and prior releases are freely available at https://bridgmodel.nci.nih.gov . © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: email@example.com
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.
Baker, Thomas; Keizer, Johannes
FAO, the Food and Agriculture Organization of the UN, has the global goal to defeat hunger and eliminate poverty. One of its core functions is the generation, dissemination and application of information and knowledge. Since 2000, the Agricultural InformationManagement Standards (AIMS) activity in FAO's Knowledge Exchange and Capacity Building Division has promoted the use of Semantic Web standards to improve information sharing within a global network of research institutes and related partner organizations. The strategy emphasizes the use of simple descriptive metadata, thesauri, and ontologies for integrating access to information from a wide range of sources for both scientific and non-expert audiences. An early adopter of Semantic Web technology, the AIMS strategy is evolving to help information providers in nineteen language areas use modern Linked Data methods to improve the quality of life in developing rural areas, home to seventy percent of the world's poor and hungry people.
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.
Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M
are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes......Groin pain in athletes is a priority area for sports physiotherapy and sports medicine research. Heterogeneous studies with low methodological quality dominate research related to groin pain in athletes. Low-quality studies undermine the external validity of research findings and limit the ability...... to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards...
Cianchetti, Carlo; Pasculli, Marcello; Pittau, Andrea; Campus, Maria Grazia; Carta, Valeria; Littarru, Roberta; Fancello, Giuseppina Sannio; Zuddas, Alessandro; Ledda, Maria Giuseppina
The Child and Adolescent Behavior Inventory (CABI) is a questionnaire designed to collect information from the parents of children and adolescents, both for the preparation of screening and epidemiological studies and for clinical evaluation. It has been published in CPEMH in 2013, with the first data on 8-10 years old school children. Here we report an extended standardization on a school population 6-17 years old and the first results of the application in a clinical sample. Parents, after giving their informed consent, answered to the questionnaire. Complete and reliable data were obtained from the parents of 659 school children and adolescents 6-17 y.o., with a balanced distribution of gender. Moreover, in a population of 84 patients, the results with the CABI were compared with the clinical evaluation and the CBCL. In the school population, scores were different in relation to gender and age. The values of externalizing disorders were higher in males, with the highest values for ADHD in the 6-10 y.o. children. On the contrary, the scores of internalizing disorders and of eating disorders tended to be slightly higher in females. In the clinical population, scores at the CABI were in agreement with the clinical evaluation in 84% cases for depressive symptoms (compared to CBCL 66%), 53% for anxiety symptoms (CBCL 42%) and 87% for ODD (CBCL 69%), differences, however; without statistical significance (chi square). The study obtained normative data for the CABI and gave information of the behavioral differences in relation to age and gender of the school population as evaluated by parents/caregivers. Clinically, the CABI provided useful information for the clinical evaluation of the patient, sometimes with better agreement with the final diagnosis compared to the CBCL.
Gibbons, Susanne W; Adamo, Graceanne; Padden, Diane; Ricciardi, Richard; Graziano, Marjorie; Levine, Eugene; Hawkins, Richard
Clinical education is critically important because competency in practice ultimately will determine the future of advanced practice nursing. Skills taught in Health Assessment, the first in a series of clinical courses, exposed students to tools that form the basis on which other competencies are built. The availability of standardized patients, people who participate in enacting a simulated but seemingly "real life" clinical encounter in a realistic clinical setting for the benefit of student learning and/or evaluation, made this instructional development project possible. The underlying assumption of this project was that clinical advanced practice nursing student education is enhanced by using an authentic clinical environment, known as a simulation center, with standardized patients and by using one or more evaluation techniques with multiple evaluators (i.e., peer, self, faculty, standardized patient). The student clinical experience was expected to improve and overall learning to increase by this method. This improvement was reflected at the end-of-course evaluations and in the quality of the final videotaped physical examination, which was superior to previous years. Student and faculty satisfaction with this teaching-learning process exceeded all expectations.
Radiotherapy practitioners may be best placed to undertake qualitative research within the context of cancer, due to specialist knowledge of radiation treatment and sensitivity to radiotherapy patient's needs. The grounded theory approach to data collection and analysis is a unique method of identifying a theory directly based on data collected within a clinical context. Research for radiotherapy practitioners is integral to role expansion within the government's directive for evidence-based practice. Due to the paucity of information on qualitative research undertaken by radiotherapy radiographers, this article aims to assess the potential impact of qualitative research on radiotherapy patient and service outcomes.
Fischer, Bernard A.; McMahon, Robert P.; Meyer, Walter A.; Slack, Daniel J.; Appelbaum, Paul S.; Carpenter, William T.
Objective Cognitive impairment is a characteristic of schizophrenia. This impairment may affect the retention of information required for ongoing knowledgeable participation in clinical trials. This study monitored retention of study-related knowledge--including assessment of therapeutic misconception--in people with stable, DSM-IV schizophrenia during participation in placebo-controlled clinical trials of adjunctive agents. Stability was defined as being on an antipsychotic with no change in medication or dose over the previous 4 weeks. Method Individuals enrolling in one of seven clinical trials were approached for participation. Participants came from research clinics and community mental health centers. At baseline, clinical trial consent forms were reviewed and study knowledge assessed. Participants were randomized to follow-up assessments at weeks 1, 4, and 8; weeks 4 and 8; or at week 8 only. Clinical trial consent forms were not re-reviewed at any follow-up visit. Results Fifty-nine participants were enrolled; analysis included 52 participants with at least one follow-up visit. Study knowledge did not decrease meaningfully in any group. Therapeutic misconception was not observed in participants during the study. The group assessed most frequently demonstrated significant improvement over baseline (t44= 3.43, p= 0.001). Retention of study knowledge was not related to symptoms, but had a weak correlation with cognitive capacity (R= 0.28, p= 0.07). Performance did not differ between participants from research clinics and those from community mental health centers. Conclusions Clinically-stable people with schizophrenia enrolling in a placebo-controlled adjunctive medication study, once determined to have capacity to consent to a clinical trial, retained appropriate study knowledge for at least 8 weeks. In the absence of a specific reason to suspect a loss of decisional capacity, there appears to be no need to routinely re-evaluate participants during this type
Full Text Available Delivery of geospatial information over the Internet for the management of risks from invasive alien species is an increasingly important service. The evolution of information technology standards for geospatial data is a key factor to simplify network publishing and exchange of maps and data. The World Wide Web Consortium (W3C-geolocation specification is a recent addition that may prove useful for pest risk management. In this article we implement the W3C-geolocation specification and Open Geospatial Consortium (OGC mapping standards in a Web browser application for smartphones and tablet computers to improve field surveys for alien invasive species. We report our first season field experiences using this tool for online mapping of plant disease outbreaks and host plant occurrence. It is expected that the improved field data collection tools will result in increased data availability and thereby new opportunities for risk assessment, because data-needs and availability are crucial for species distribution modelling and model-based forecasts of pest establishment potential. Finally, we close with a comment on the future potential of geospatial information standards to enhance the translation from data to decisions regarding pest risks, which should enable earlier detection of emerging risks as well as more robust projections of pest risks in novel areas. The forthcoming standard for processing of geospatial information, the Web Processing Standard (WPS, should open new technological capabilities both for automatic initiation and updating of risk assessment models based on new incoming data, and subsequent early warning.
García, Cristina; Ruíz, Jesús; Gallinar, David; Sánchez de Posada, Covadonga
Several climatic risks studies based on the analysis of data recorded in newspapers have been published to date. These studies deal with both general (Moltó, 2000; García y Martí, 2000; Hernández Varela et al., 2003; Olcina, 2005) and specific risks such as landslides (Domínguez et al., 1999; Devoli et al., 2007; Polemio y Petrucci, 2010) seastorms (Yanes y Marzol, 2009) and snowstorms (Olcina y Moltó, 2002) among others. The purpose of this paper is to report on the methodology and results of the study of an extreme historical event happened in the Asturian Massif (Northern Spain) in 1888. Special attention has been paid to methodological aspects and to the difficulties found in the goal of devising a method that would enable the reconstruction of this kind of phenomena on the basis of nivometheorogical conditions, geographical location and socio-economic impact. To a great deal we focused our efforts on designing a logical database structure and a set of tables that would allow us to store and cross the information for statistical analysis. This includes outlier detection in order to ensure the quality of the results. The information sources used in our study have been the issues of the daily newspaper 'El Carbayón' and the weekly newspaper 'El Oriente de Asturias' published in Oviedo and Llanes (Asturias) between the 20th of January and 30th of May 1888. A total of 92 issues have been collected via the hard copy microfilm housed in the Central Library of Asturias. We reviewed 70 reports relating to avalanche events happened in the aforementioned period of time. We grouped the consequences of the events into 3 main categories (personal injuries, material damages and absence of both) and 5 child categories (deaths, wounded, house and attached building damage, livestock injuries, damage to infrastructures and communications). We gathered data about the thickness of snow-cover, the number of consecutive snowstorms and, in order to facilitate a territorial
Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold
Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414
Anderson, Carina; Moxham, Lorna; Broadbent, Marc
This discussion paper poses the question 'What enables or deters Registered Nurses to take up their professional responsibility to support undergraduate nursing students through the provision of clinical education?'. Embedded within many nursing standards are expectations that Registered Nurses provide support and professional development to undergraduate nursing students undertaking clinical placements. Expectations within nursing standards that Registered Nurses provide support and professional development to nursing students are important because nursing students depend on Registered Nurses to help them to become competent practitioners. Contributing factors that enable and deter Registered Nurses from fulfilling this expectation to support nursing students in their clinical learning include; workloads, preparedness for the teaching role, confidence in teaching and awareness of the competency requirement to support students. Factors exist which can enable or deter Registered Nurses from carrying out the licence requirement to provide clinical education and support to nursing students.
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.
Full Text Available Georeferenced 3D models represent an increasingly accepted solution for storing and displaying information at urban scale. CityGML, as standard data model for the representation, storage and exchange of 3D city models, represent a very attractive solution which combines 3D geometric and semantic information in a single data model. In this paper we present an approach to visualize semantic and 3D information of historical centers using open standards. Also, three client applications are presented targeting different agents with different needs with the characteristic that all the information is got from an unique extended CityGML data model.
Majhail, Navneet S; Giralt, Sergio; Bonagura, Anthony; Crawford, Stephen; Farnia, Stephanie; Omel, James L; Pasquini, Marcelo; Saber, Wael; LeMaistre, Charles F
The Patient Protection and Affordable Care Act requires that health care insurers cover routine patient costs associated with participating in clinical trials for cancer and other life-threatening diseases. There is a need to better define routine costs within the context of hematopoietic stem cell transplantation (HSCT) clinical trials. This white paper presents guidance on behalf of the American Society for Blood and Marrow Transplantation for defining a standard HSCT episode and delineates components that may be considered as routine patient costs versus research costs. The guidelines will assist investigators, trial sponsors, and transplantation centers in planning for clinical trials that are conducted as a part of the HSCT episode and will inform payers who provide coverage for transplantation. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
Kraus, V B; Blanco, F J; Englund, M
Osteoarthritis (OA) is a heterogeneous disorder. The goals of this review are (1) To stimulate use of standardized nomenclature for OA that could serve as building blocks for describing OA and defining OA phenotypes, in short to provide unifying disease concepts for a heterogeneous disorder; and (2......) To stimulate establishment of ROAD (Risk of OA Development) and ROAP (Risk of OA Progression) tools analogous to the FRAX™ instrument for predicting risk of fracture in osteoporosis; and (3) To stimulate formulation of tools for identifying disease in its early preradiographic and/or molecular stages - REDI...... (Reliable Early Disease Identification). Consensus around more sensitive and specific diagnostic criteria for OA could spur development of disease modifying therapies for this entity that has proved so recalcitrant to date. We fully acknowledge that as we move forward, we expect to develop more...
Kraus, V B; Blanco, F J; Englund, M; Karsdal, M A; Lohmander, L S
Osteoarthritis (OA) is a heterogeneous disorder. The goals of this review are (1) To stimulate use of standardized nomenclature for OA that could serve as building blocks for describing OA and defining OA phenotypes, in short to provide unifying disease concepts for a heterogeneous disorder; and (2) To stimulate establishment of ROAD (Risk of OA Development) and ROAP (Risk of OA Progression) tools analogous to the FRAX™ instrument for predicting risk of fracture in osteoporosis; and (3) To stimulate formulation of tools for identifying disease in its early preradiographic and/or molecular stages - REDI (Reliable Early Disease Identification). Consensus around more sensitive and specific diagnostic criteria for OA could spur development of disease modifying therapies for this entity that has proved so recalcitrant to date. We fully acknowledge that as we move forward, we expect to develop more sophisticated definitions, terminology and tools. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
Callender, E. David; Steinbacher, Jody
This is the fifth of five volumes on Information System Life-Cycle and Documentation Standards. This volume provides a well organized, easily used standard for management control and status reports used in monitoring and controlling the management, development, and assurance of informations systems and software, hardware, and operational procedures components, and related processes.
Callender, E. David; Steinbacher, Jody
This is the second of five volumes of the Information System Life-Cycle and Documentation Standards. This volume provides a well-organized, easily used standard for management plans used in acquiring, assuring, and developing information systems and software, hardware, and operational procedures components, and related processes.
Liebe, J D; Hübner, U; Straede, M C; Thye, J
assume ideal workflows as a gold standard but measures IT support of clinical workflows according to validated descriptors a high portability of the WCS to other hospitals in other countries is very likely. The WCS will contribute to a better understanding of the construct clinical information logistics.
Kjersti Marie Blytt
Full Text Available Abstract Background Sleep disturbances are widespread among nursing home (NH patients and associated with numerous negative consequences. Identifying and treating them should therefore be of high clinical priority. No prior studies have investigated the degree to which sleep disturbances as detected by actigraphy and by the sleep-related items in the Cornell Scale for Depression in Dementia (CSDD and the Neuropsychiatric Inventory – Nursing Home version (NPI-NH provide comparable results. Such knowledge is highly needed, since both questionnaires are used in clinical settings and studies use the NPI-NH sleep item to measure sleep disturbances. For this reason, insight into their relative (disadvantages is valuable. Method Cross-sectional study of 83 NH patients. Sleep was objectively measured with actigraphy for 7 days, and rated by NH staff with the sleep items in the CSDD and the NPI-NH, and results were compared. McNemar's tests were conducted to investigate whether there were significant differences between the pairs of relevant measures. Cohen's Kappa tests were used to investigate the degree of agreement between the pairs of relevant actigraphy, NPI-NH and CSDD measures. Sensitivity and specificity analyses were conducted for each of the pairs, and receiver operating characteristics (ROC curves were designed as a plot of the true positive rate against the false positive rate for the diagnostic test. Results Proxy-raters reported sleep disturbances in 20.5% of patients assessed with NPI-NH and 18.1% (difficulty falling asleep, 43.4% (multiple awakenings and 3.6% (early morning awakenings of patients had sleep disturbances assessed with CSDD. Our results showed significant differences (p<0.001 between actigraphy measures and proxy-rated sleep by the NPI-NH and CSDD. Sensitivity and specificity analyses supported these results. Conclusions Compared to actigraphy, proxy-raters clearly underreported NH patients' sleep disturbances as assessed
Tsohou, Aggeliki; Kokolakis, Spyros; Lambrinoudakis, Costas; Gritzalis, Stefanos
The need for common understanding and agreement of functional and non-functional requirements is well known and understood by information system designers. This is necessary for both: designing the "correct" system and achieving interoperability with other systems. Security is maybe the best example of this need. If the understanding of the security requirements is not the same for all involved parties and the security mechanisms that will be implemented do not comply with some globally accepted rules and practices, then the system that will be designed will not necessarily achieve the desired security level and it will be very difficult to securely interoperate with other systems. It is therefore clear that the role and contribution of international standards to the design and implementation of security mechanisms is dominant. In this paper we provide a state of the art review on information security management standards published by the International Organization for Standardization and the International Electrotechnical Commission. Such an analysis is meaningful to security practitioners for an efficient management of information security. Moreover, the classification of the standards in the clauses of ISO/IEC 27001:2005 that results from our analysis is expected to provide assistance in dealing with the plethora of security standards.
Full Text Available Despite the routine nature of comparing sequence variations identified during clinical testing to database records, few databases meet quality requirements for clinical diagnostics. To address this issue, The Royal College of Pathologists of Australasia (RCPA in collaboration with the Human Genetics Society of Australasia (HGSA, and the Human Variome Project (HVP is developing standards for DNA sequence variation databases intended for use in the Australian clinical environment. The outputs of this project will be promoted to other health systems and accreditation bodies by the Human Variome Project to support the development of similar frameworks in other jurisdictions.
Mussini, C.; Antinori, A.; Bhagani, S.; Branco, T.; Brostrom, M.; Dedes, N.; Bereczky, T.; Girardi, E.; Gökengin, D.; Horban, A.; Lacombe, K.; Lundgren, J. D.; Mendao, L.; Mocroft, A.; Oprea, C.; Porter, K.; Podlekareva, D.; Battegay, M.; d'Arminio Monforte, A.; Mulcahy, Fiona; Geretti, Anna Maria; Clumeck, Nathan; Reiss, Peter; Arribas, Jose; Gatell, Jose; Katlama, Christine; Pozniak, Anton; Rockstroh, Jürgen; Youle, Mike; Friis-Møller, Nina; Rusconi, Stefano; Behrens, Georg; de Wit, Stéphane; Furrer, Hansjakob; Wensing, Annemarie; John Gill, M.; Letendre, Scott
The objective of the 1st European AIDS Clinical Society meeting on Standard of Care in Europe was to raise awareness of the European scenario and come to an agreement on actions that could be taken in the future. Data-driven presentations were given on specific topics followed by interactive panel
Mussini, C.; Antinori, A.; Bhagani, S.; Branco, T.; Brostrom, M.; Dedes, N.; Bereczky, T.; Girardi, E.; Gökengin, D.; Horban, A.; Lacombe, K.; Lundgren, J. D.; Mendao, L.; Mocroft, A.; Oprea, C.; Porter, K.; Podlekareva, D.; Battegay, M.; d'Arminio Monforte, A.; Mulcahy, Fiona; Geretti, Anna Maria; Clumeck, Nathan; Reiss, Peter; Arribas, Jose; Gatell, Jose; Katlama, Christine; Pozniak, Anton; Rockstroh, Jürgen; Youle, Mike; Friis-Møller, Nina; Rusconi, Stefano; Behrens, Georg; De Wit, Stéphane; Furrer, Hansjakob; Wensing, Annemarie|info:eu-repo/dai/nl/30817724X; John Gill, M.; Letendre, Scott
Objectives: The objective of the 1st European AIDS Clinical Society meeting on Standard of Care in Europe was to raise awareness of the European scenario and come to an agreement on actions that could be taken in the future. Methods: Data-driven presentations were given on specific topics followed
Armstrong, Kirk J.; Jarriel, Amanda J.
Context: Researchers have reported that interacting with standardized patients (SPs) is a worthwhile and realistic experience for athletic training (AT) students. These encounters enhance students' interviewing skills, confidence as a clinician, clinical skill development, and interpersonal communication. Objective: To determine how SP encounters…
De Wit, S; Battegay, M; D'Arminio Monforte, A
The European AIDS Clinical Society (EACS) organized a second meeting on Standard of Care in Europe on November 16-17 th, 2016. The aims of the meeting were to discuss and propose actions on three topics, namely: Adherence to guidelines for treatment initiation, treatment monitoring and outcomes, ...
Cunningham, S G; Carinci, F; Brillante, M; Leese, G P; McAlpine, R R; Azzopardi, J; Beck, P; Bratina, N; Bocquet, V; Doggen, K; Jarosz-Chobot, P K; Jecht, M; Lindblad, U; Moulton, T; Metelko, Ž; Nagy, A; Olympios, G; Pruna, S; Skeie, S; Storms, F; Di Iorio, C T; Massi Benedetti, M
A set of core diabetes indicators were identified in a clinical review of current evidence for the EUBIROD project. In order to allow accurate comparisons of diabetes indicators, a standardised currency for data storage and aggregation was required. We aimed to define a robust European data dictionary with appropriate clinical definitions that can be used to analyse diabetes outcomes and provide the foundation for data collection from existing electronic health records for diabetes. Existing clinical datasets used by 15 partner institutions across Europe were collated and common data items analysed for consistency in terms of recording, data definition and units of measurement. Where necessary, data mappings and algorithms were specified in order to allow partners to meet the standard definitions. A series of descriptive elements were created to document metadata for each data item, including recording, consistency, completeness and quality. While datasets varied in terms of consistency, it was possible to create a common standard that could be used by all. The minimum dataset defined 53 data items that were classified according to their feasibility and validity. Mappings and standardised definitions were used to create an electronic directory for diabetes care, providing the foundation for the EUBIROD data analysis repository, also used to implement the diabetes registry and model of care for Cyprus. The development of data dictionaries and standards can be used to improve the quality and comparability of health information. A data dictionary has been developed to be compatible with other existing data sources for diabetes, within and beyond Europe.
Bill, Robert; Pakhomov, Serguei; Chen, Elizabeth S.; Winden, Tamara J.; Carter, Elizabeth W.; Melton, Genevieve B.
Despite increased functionality for obtaining family history in a structured format within electronic health record systems, clinical notes often still contain this information. We developed and evaluated an Unstructured Information Management Application (UIMA)-based natural language processing (NLP) module for automated extraction of family history information with functionality for identifying statements, observations (e.g., disease or procedure), relative or side of family with attributes (i.e., vital status, age of diagnosis, certainty, and negation), and predication (“indicator phrases”), the latter of which was used to establish relationships between observations and family member. The family history NLP system demonstrated F-scores of 66.9, 92.4, 82.9, 57.3, 97.7, and 61.9 for detection of family history statements, family member identification, observation identification, negation identification, vital status, and overall extraction of the predications between family members and observations, respectively. While the system performed well for detection of family history statements and predication constituents, further work is needed to improve extraction of certainty and temporal modifications. PMID:25954443
The American Association of School Librarians "Standards for the 21st Century Learner" (2007) expresses nine fundamental common beliefs. One of these beliefs is that "ethical behavior in the use of information must be taught" (AASL 2007, 1). It is important for library media specialists to understand that teaching ethical behavior is much more…
Ryan, David L.
While research in academic and professional information technology (IT) journals address the need for strategic alignment and defined IT processes, there is little research about what factors should be considered when implementing specific IT hardware standards in an organization. The purpose of this study was to develop a set of factors for…
..., OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC... (Technical Industry Standards) Activities Under OMB Review AGENCY: Office of Acquisition and Logistics... INFORMATION OR A COPY OF THE SUBMISSION CONTACT: Denise McLamb, Enterprise Records Service (005R1B...
Estruch, Marcie Jane
This study sought to determine the relationship between teachers' attitudes toward the Common Core State Standards and three predetermined factors. These factors were (1) teachers' attitudes toward the practicality of pedagogical shift three, balancing informational and literary texts, (2) teachers' attitudes toward school support with the…
... Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and... Health HL7 Health Level Seven NAICS North American Industry Classification System OMB Office of...-Authorized Testing and Certification Body PHSA Public Health Service Act RFA Regulatory Flexibility Act RIA...
... Department of Labor publication Union Member Rights and Officer Responsibilities under the Civil Service..., the site must contain a conspicuous link to Union Member Rights and Officer Responsibilities under the... 29 Labor 2 2010-07-01 2010-07-01 false Informing members of the standards of conduct provisions...
Gordon, Larissa; Bartoli, Eleonora
This article describes the outcome of a collaboration between a faculty member and a librarian to integrate information literacy into a graduate counseling psychology program. This collaboration used discipline-based standards from a professional association (the Association of Counselor Education and Supervision, ACES) to provide instructional…
Full Text Available Academic librarians should expand our understanding of what counts as an authoritative resource, and be unafraid to challenge long-established wisdom in this domain. Wikipedia is far from perfect, but neither is the Encyclopedia Britannica. Wikipedia is updated daily, while the Britannica is no longer printed. If we cling to the Britannica as a symbol of authoritativeness, we will become obsolete ourselves. One way to prevent this fate is to reframe our collective thinking. In 2014 the Association of College and Research Libraries (ACRL will issue a revised version of the Information Literacy Competency Standards for Higher Education. The task force shepherding this revision (ACRL, 2012 argues that the standards “should not be reapproved as they exist but should be extensively revised” (pg. 1. This is because the Internet has profoundly altered the ways in which we create, share, analyze and validate information. To be credible, the new ACRL standards must take full account of this change.
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
Aziz, Nazneen; Zhao, Qin; Bry, Lynn; Driscoll, Denise K; Funke, Birgit; Gibson, Jane S; Grody, Wayne W; Hegde, Madhuri R; Hoeltge, Gerald A; Leonard, Debra G B; Merker, Jason D; Nagarajan, Rakesh; Palicki, Linda A; Robetorye, Ryan S; Schrijver, Iris; Weck, Karen E; Voelkerding, Karl V
The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or "dry bench" analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results . -A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP's molecular pathology checklist (MOL). This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality.
Helbig, Matthias; Helbig, Silke; Kahla-Witzsch, Heike A; Kroll, Tobias; May, Angelika
Against statutory duties to introduce quality management systems, the increased importance of this subject has led to numerous activities in various public health institutions. Following the International Standardization Organization (ISO 9001:2000) prerequisites, Frankfurt Goethe University Hospital ENT clinic staff introduced a quality management system. This paper aims to investigate this process. Designing, planning and implementing the quality management system is described. Under the supervision of an executive quality management board, clinic quality goals were defined. Thereafter, several quality management teams performed an actual state analysis as well as developing and realising improvement proposals. Finally a quality management manual containing binding standards and working instructions concerning all patient care, research and teaching aspects was written. Successful certification by a neutral body ascertained that the clinic's quality management system conformed to current national and international standards while restructuring and reform improved procedural efficiency. The paper shows that mplementing the quality management system requires considerable effort but patients as well as staff profit considerably from the innovation. On the whole, the positive impact on structure and workflow in a specialist clinic predominates. Therefore, implementing a quality management system in all the clinic's wards and departments is recommended.
Perkins, A.C.; Jarritt, P.H.
Aim: Audit is the process whereby the quality of a service is monitored and optimised. It forms an essential component of the quality assurance process, whether by self-assessment or by external peer review. In the UK the British Nuclear Medicine Society (BNMS) has undertaken external organisational audit of departments providing clinical nuclear medicine services. This work aimed to develop a more thorough and service specific process for the audit of scientific and technological standards in nuclear medicine. Materials and Methods: The audit process has been implemented using written audit documents to facilitate the audit procedure. A questionnaire forms part of the formal documentation for audit of the scientific and technical standards of a clinical service. Scientific and technical standards were derived from a number of sources including legal requirements, regulatory obligations, notes for guidance, peer reviewed publications and accepted good clinical practice (GCP). Results: The audit process graded the standards of an individual department according to legal or safety requirements (Grade A), good practice (Grade B) and desirable aspects of service delivery (Grade C). The standards have been allocated into eight main categories. These are: Instrumentation; Software and data protection; Electrical Safety; Mechanical Safety; Workstation Safety; The Control of Substances Hazardous to Health (COSHH); Radiation Protection; Scientific and Technical staffing levels. During the audit visit a detailed inspection of clinical and laboratory areas and department written documentation is also necessary to validate the data obtained. Conclusion: The printed scheme now provides a means for external audit or self-assessment. There should be evidence of a well-organised and safe environment for both patients and staff. Health and Safety legislation requires written local rules and these records should be available to demonstrate the standard of service provision. Other
With NRC concurrence, the Licensing Plan for the Standard HTGR describes an application program consistent with 10CFR50, Appendix O to support a US Nuclear Regulatory Commission (NRC) review and design certification of an advanced Standard modular High Temperature Gas-Cooled Reactor (MHTGR) design. Consistent with the NRC's Advanced Reactor Policy, the Plan also outlines a series of preapplication activities which have as an objective the early issuance of an NRC Licensability Statement on the Standard MHTGR conceptual design. This Preliminary Safety Information Document (PSID) has been prepared as one of the submittals to the NRC by the US Department of Energy in support of preapplication activities on the Standard MHTGR. Other submittals to be provided include a Probabilistic Risk Assessment, a Regulatory Technology Development Plan, and an Emergency Planning Bases Report.
Vesper, Hubert W; Myers, Gary L; Miller, W Greg
Effective patient care, clinical research, and public health efforts require comparability of laboratory results independent of time, place, and measurement procedure. Comparability is achieved by establishing metrological traceability, which ensures that measurement procedures measure the same quantity and that the calibration of measurement procedures is traceable to a common reference system consisting of reference methods and materials. Whereas standardization ensures traceability to the International System of Units, harmonization ensures traceability to a reference system agreed on by convention. This article provides an overview of standardization and harmonization with an emphasis on commutability as an important variable that affects testing accuracy. Commutability of reference materials is required to ensure that traceability is established appropriately and that laboratory results are comparable. The use of noncommutable reference materials leads to inaccurate results. Whereas procedures and protocols for standardizing measurements are established and have been successfully applied in efforts such as the Hormones Standardization Program of the CDC, harmonization activities require new, more complex procedures and approaches. The American Association for Clinical Chemistry, together with its domestic and international partners, formed the International Consortium for Harmonization of Clinical Laboratory Results to coordinate harmonization efforts. Reference systems, as well as procedures and protocols to establish traceability of clinical laboratory tests, have been established and continue to be developed by national and international groups and organizations. Serum tests of thyroid function, including those for the thyroid hormones thyroxine and triiodothyronine, are among the clinical procedures for which standardization efforts are well under way. Approaches to the harmonization of measurement procedures for serum concentrations of thyroid
Quast, U.; Boehm, J.; Kaulich, T.W.
Beta radiation has found increasing interest in radiotherapy. Besides the curative treatment of small and medium-sized intraocular tumors by means of ophthalmic beta radiation plaques, intravascular brachytherapy has proven to successfully overcome the severe problem of restenosis after interventional treatment of arterial stenosis in coronaries and peripheral vessels in many clinical trials with a large number of patients. Prior to initiating procedures applying beta radiation in radiotherapy, however, there is a common need to specify methods for the determination and specification of the absorbed dose to water or tissue and their spatial distributions. The IAEA-TECDOC-1274 Calibration of photon and beta ray sources used in brachytherapy (2002) is a help for photon brachytherapy calibration. But, for beta seed and line sources, IAEA recommends well type ionization chambers as working standards which are far from measuring absorbed dose to water of the radiation clinically used. Although the application of such working standards seems to be more precise, large errors can occur when the medical physicist has to convert the calibration data to absorbed dose to water of the beta radiation emitted. The user must believe that the source is equally activated and that the manufacturer did not change the design and construction of the source encapsulation. With the DGMP Report 16 (2001) Guidelines for medical physical aspects of intravascular brachytherapy a very detailed code of practice is given, especially for the calibration and clinical dosimetry of intravascular beta radiation sources. As there is a global need for standardization in clinical dosimetry for intravascular brachytherapy utilizing beta radiation, the DIN-NAR, the German committee on standardization in radiology, task group dosimetry, has initiated an international adhoc working group for a new ISO work item proposal on the standardization of procedures in clinical dosimetry to guarantee reliable
Daniel, C; Choquet, R
To summarize advances of excellent current research in the new emerging field of Clinical Research Informatics. Synopsis of four key articles selected for the IMIA Yearbook 2013. The selection was performed by querying PubMed and Web of Science with predefined keywords. From the original set of 590 papers, a first subset of 461 articles which was in the scope of Clinical Research Informatics was refined into a second subset of 79 relevant articles from which 15 articles were retained for peer-review. The four selected articles exemplify current research efforts conducted in the areas of data representation and management in clinical trials, secondary use of EHR data for clinical research, information technology platforms for translational and comparative effectiveness research and implementation of privacy control. The selected articles not only illustrate how innovative information technology supports classically organized randomized controlled trials but also demonstrate that the long promised benefits of electronic health care data for research are becoming a reality through concrete platforms and projects.
Renata Turola Takamatsu
Full Text Available Purpose – The goal of this study was to investigate the relationship between the level of Earnings Opacity and a company’s informational environment, specifically considering accounting standards and the legal origins of the system. Design/methodology/approach – The sample consisted of publicly traded companies from 20 countries classified as emerging, based on agency Standard & Poor’s index. The sample included data from 2004 to 2013. In order to compare the indicators among the group of countries, taking into account their institutional characteristics, the Mann-Whitney test and the Kruskal-Wallis test were performed. Findings – The assessment of the informational environment measures’ behavior in emerging countries revealed that these measures were correlated, suggesting that, despite different behaviors, opacity proxies share information. The fact that earnings opacity was lower in countries that had already adopted international standards during the analyzed period was also observed. In the same sense, a higher level of income smoothing was detected in countries of French code law origins. Originality/value – This article contributes to the understanding of the relationship between the characteristics of an accounting informational environment and the levels of opacity of the information emitted by accounting. Thus, this article has helped managers, investors and regulators to understand users’ needs and how country-specific characteristics change their perspectives.
Akwar, Holy; Kloeze, Harold; Mukhi, Shamir
To validate the utility and effectiveness of a standardized tool for prioritization of information sources for early detection of diseases. The tool was developed with input from diverse public health experts garnered through survey. Ten raters used the tool to evaluate ten information sources and reliability among raters was computed. The Proc mixed procedure with random effect statement and SAS Macros were used to compute multiple raters' Fleiss Kappa agreement and Kendall's Coefficient of Concordance. Ten disparate information sources evaluated obtained the following composite scores: ProMed 91%; WAHID 90%; Eurosurv 87%; MediSys 85%; SciDaily 84%; EurekAl 83%; CSHB 78%; GermTrax 75%; Google 74%; and CBC 70%. A Fleiss Kappa agreement of 50.7% was obtained for ten information sources and 72.5% for a sub-set of five sources rated, which is substantial agreement validating the utility and effectiveness of the tool. This study validated the utility and effectiveness of a standardized criteria tool developed to prioritize information sources. The new tool was used to identify five information sources suited for use by the KIWI system in the CEZD-IIR project to improve surveillance of infectious diseases. The tool can be generalized to situations when prioritization of numerous information sources is necessary.
Amy Jo Catalano
Full Text Available Objective - This study investigates the information literacy of graduate education students, including those in doctoral cohorts. The Association for Research and College Libraries Information Literacy Standards were used a baseline for measurement.Methods - A survey was sent to all graduate students in the School of Education; it asked a combination of questions measuring students’ perceptions of their information literacy skills and testing their knowledge of information literacy.Results – A total of 172 surveys were returned. The results indicated that while there is a heavy reliance on internet sources, many students were able to determine which sources were reliable and which were not. After attending information instruction sessions, students were more familiar with library services and more inclined to use them.Conclusion - It was determined that a one credit course or multiple sessions of library instruction would better serve graduate students completing capstone projects.
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.
Cardona, Aristoteles Alvarez; Nieto, Leticia Hernandez; Melendez, Alvaro Pedroza
Background Bee venom immunotherapy is a safe and effective treatment, indicated in patients with previous history of severe systemic reactions to bee venom, demonstrating succesful desensitization in more than 90% of cases with standardized extract. Currently in Mexico there is no standardized extract commercially available for treatment, despite of having high activity of beekeeping and occupational exposure with at least 17,478 registered stings per year and an annually honey production of nearly 70 tons. Methods We present the clinical progress of 2 patients with history of severe systemic reactions to bee venom and occupational exposure, both with demonstrated sensitization by specific IgE and who underwent specific immunotherapy with standardized extract (Alk-US) reaching a maintenance weekly dose of 100 mcg (PLA2) for the last 4 years. Results Both patients sufered of accidental stings after reached the maintenance dose presenting mild local reactions to stings. Both patients had very different clinical course presenting a wide variety of adverse reactions during desensitization protocol; from mild local to generalized reactions all generally well tolerated allowed to reach the maintenance dose with succesful desensitization proved by accidental exposure without severe systemic reactions. Conclusions Bee venom specific immunotherapy with standardized extract is a well tolerated and efective treatment preventing the development of life threathening reactions in sensitized patients. It is important to promote the use and availability of standardized extract in developing countries with poor safety measures and high occupational exposure.
Carrier, Jean-Francois; D'Amours, Michel; Verhaegen, Frank; Reniers, Brigitte; Martin, Andre-Guy; Vigneault, Eric; Beaulieu, Luc
Purpose: To use the Monte Carlo (MC) method as a dose calculation engine for postimplant dosimetry. To compare the results with clinically approved data for a sample of 28 patients. Two effects not taken into account by the clinical calculation, interseed attenuation and tissue composition, are being specifically investigated. Methods and Materials: An automated MC program was developed. The dose distributions were calculated for the target volume and organs at risk (OAR) for 28 patients. Additional MC techniques were developed to focus specifically on the interseed attenuation and tissue effects. Results: For the clinical target volume (CTV) D 90 parameter, the mean difference between the clinical technique and the complete MC method is 10.7 Gy, with cases reaching up to 17 Gy. For all cases, the clinical technique overestimates the deposited dose in the CTV. This overestimation is mainly from a combination of two effects: the interseed attenuation (average, 6.8 Gy) and tissue composition (average, 4.1 Gy). The deposited dose in the OARs is also overestimated in the clinical calculation. Conclusions: The clinical technique systematically overestimates the deposited dose in the prostate and in the OARs. To reduce this systematic inaccuracy, the MC method should be considered in establishing a new standard for clinical postimplant dosimetry and dose-outcome studies in a near future
Abstract Background A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. Methods International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. Results The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit
Schou Jensen, Iben; Koldby, Sven
Clinical information systems do not always support clinician workflows. An increasing number of unintended clinical inci-dents might be related to implementation of clinical infor-mation systems and to a new registration praxis of unin-tended 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...
Sibley, Kathryn M; Straus, Sharon E; Inness, Elizabeth L; Salbach, Nancy M; Jaglal, Susan B
Balance impairment is common in multiple clinical populations, and comprehensive assessment is important for identifying impairments, planning individualized treatment programs, and evaluating change over time. However, little information is available regarding whether clinicians who treat balance are satisfied with existing assessment tools. In 2010 we conducted a cross-sectional survey of balance assessment practices among physiotherapists in Ontario, Canada, and reported on the use of standardized balance measures (Sibley et al. 2011 Physical Therapy; 91: 1583-91). The purpose of this study was to analyse additional survey data and i) evaluate satisfaction with current balance assessment practices and standardized measures among physiotherapists who treat adult or geriatric populations with balance impairment, and ii) identify factors associated with satisfaction. The questionnaire was distributed to 1000 practicing physiotherapists. This analysis focuses on questions in which respondents were asked to rate their general perceptions about balance assessment, the perceived utility of individual standardized balance measures, whether they wanted to improve balance assessment practices, and why. Data were summarized with descriptive statistics and utility of individual measures was compared across clinical practice areas (orthopaedic, neurological, geriatric or general rehabilitation). The questionnaire was completed by 369 respondents, of which 43.4% of respondents agreed that existing standardized measures of balance meet their needs. In ratings of individual measures, the Single Leg Stance test and Berg Balance Scale were perceived as useful for clinical decision-making and evaluating change over time by over 70% of respondents, and the Timed Up-and-Go test was perceived as useful for decision-making by 56.9% of respondents and useful for evaluating change over time by 62.9% of respondents, but there were significant differences across practice groups. Seventy
Atalag, Koray; Yang, Hong Yul; Tempero, Ewan; Warren, Jim
openEHR and the recent international standard (ISO 13606) defined a model driven software development methodology for health information systems. However there is little evidence in the literature describing implementation; especially for desktop clinical applications. This paper presents an implementation pathway using .Net/C# technology for Microsoft Windows desktop platforms. An endoscopy reporting application driven by openEHR Archetypes and Templates has been developed. A set of novel GUI directives has been defined and presented which guides the automatic graphical user interface generator to render widgets properly. We also reveal the development steps and important design decisions; from modelling to the final software product. This might provide guidance for other developers and form evidence required for the adoption of these standards for vendors and national programs alike.
Lee, Gihyung; Kim, Sanghyun; Lee, Gyehwi; Yoon, Yeonhwa; Song, Song Hyerim; Jeong, Jina; Byun, Jaehyung; Seo, Jonghwan
There has been an increasing emphasis on the need for increased disclosure of information through the home page of the Korea Institute of Nuclear Safety (KINS), responsible for nuclear safety regulations, and the Nuclear Safety Information Center (NSIC) to enhance public understanding of nuclear safety. However, due to the dazzled structure of the existing KINS and NSIC home pages, improvements in accessibility and convenience are necessary. At the same time, content standardization is required to increase operational efficiency and provide coherent information. In this study, the Delphi method was used to select the major contents to make available on the home page as well as the main user base definition for the home page layout development. Also, internal and external expert groups were created to conduct AHP (Analytic Hierarchy Process) analysis and develop the comparative analysis items for the U. S. Nuclear Regulatory Commission(NRC)/KINS/NSIC home pages. Afterwards, problems and points of improvements for the home page system, design, and profile were derived using heuristic analysis. The implications arising from the Delphi analysis results were applied to the home page layout. In the nuclear safety information standardized system construction process, the comparative analysis conducted using the AHP and heuristic analyses of the NRC home page resulted in deriving improvements for the Guidance, Organization, and Trustworthy items of the KINS/NSIC home page. Furthermore, through the Delphi analysis, a clear purpose and core values were set for the KINS web site, and the needs of the main user base were identified. By developing the home page layout, user interest and utility were raised to improve the organization method and layout. Through this study, KINS was able to construct a nuclear safety information standardized system and increase transparency and openness by providing feature enhancements in information provision as well as user accessibility and
Ekoto, Isaac W.; Blaylock, Myra L.; LaFleur, Angela Christine; LaChance, Jeffrey L.; Horne, Douglas B.
Safety standards development for maintenance facilities of liquid and compressed gas fueled large-scale vehicles is required to ensure proper facility design and operation envelopes. Standard development organizations are utilizing risk-informed concepts to develop natural gas vehicle (NGV) codes and standards so that maintenance facilities meet acceptable risk levels. The present report summarizes Phase I work for existing NGV repair facility code requirements and highlights inconsistencies that need quantitative analysis into their effectiveness. A Hazardous and Operability study was performed to identify key scenarios of interest. Finally, scenario analyses were performed using detailed simulations and modeling to estimate the overpressure hazards from HAZOP defined scenarios. The results from Phase I will be used to identify significant risk contributors at NGV maintenance facilities, and are expected to form the basis for follow-on quantitative risk analysis work to address specific code requirements and identify effective accident prevention and mitigation strategies.
Craig F. Berning
Full Text Available The debate as to whether to require mandatory labeling of genetically modified organism (GMO foods was partially settled on 29 July 2016, when President Obama signed the National Bioengineered Food Disclosure Standard into public law. In contrast to precipitating legislation passed by the State of Vermont that required disclosure of GMO ingredients on food shelves or food packages, the superseding National Standard allows firms to disclose bioengineered ingredients to consumers via symbols, electronic or digital links, or phone numbers, and further requires a study assessing the ability of consumers to access disclosure information by these means. This communication analyzes survey responses from 525 adults to investigate whether U.S. consumers are able to obtain information as per the disclosure methods allowed in the Federal legislation. The survey probes deeper to investigate consumer perceptions of genetically modified organisms and whether consumers would use the tools available to access disclosure about bioengineered ingredients. Findings from the survey show that 93.8% of respondents have the ability to access information via the disclosure methods permitted. Those in the lowest income group, and from the oldest age group are least likely to have such access. This provides the United State Department of Agriculture with information relevant to how they can implement the law and highlights particular demographic segments that may require additional attention to ensure the disclosed information is universally accessible.
Miguel Eduardo Pecho Trigueros
Full Text Available Tax authorities are increasingly relying on mutual cooperation with their foreign peers to enforce more effectively their internal tax laws. After the banking scandals of 2008 and the subsequent global financial crisis, the Global Forum on Transparency and Exchange of Information for TaxPurposes has proposed the exchange of information upon request as the fiscal transparency standard. However, some measures adopted by the European Union, previous initiatives from the Organization for Economic Cooperation and Development (OECD and, above all, the introduction of the Foreign Account Tax Compliance Act (Fatca by the United States in 2010 have promoted the need to adopt the automatic exchange of information as the new fiscal transparency standard. Automatic exchange of information allows home countries to verify whether their taxpayers have correctly included foreign income, allowing tax authorities to have early warning of possible noncompliance cases. In February 2014, the OECD published its proposal for a new global model of automatic exchange of financial account information. The new global model contains the necessary legal instruments and due diligence and reporting procedures, mainly for financial institutions.
Cui, Shu-Li; Tan, Kian Hian; Ong, Biauw Chi; Lim, Shih hui; Yong, Yang; Seah, Cheng Ngee; Huang, Youyi; Han, Seong Ng
The standardized management of acupuncture-moxibustion in Singapore General Hospital is introduced. With gradual improvement of outpatient infrastructure, re-training of medical staff, strict disinfection of manipulation, periodical inspection of medical instruments, unified management of writing, saving and processing in medical records and public education of TCM knowledge, a standardized management system in accordance with modernized hospital is gradually established. As a result, efficiency and quality of clinical treatment is continuously increasing. From April of 1998 to December of 2012, a total of 74 654 times of treatment were performed, and treatment amount per day is gradually increased. The unusual condition of acupuncture is avoided. Periodical strict inspection of joint committee authenticated by domestic and overseas medical health organization is repeatedly passed and accepted. Additionally, three clinical researches funded by Singapore Health-care Company are still in progress in acupuncture-moxibustion department.
Zhang, Jinghui; Tang, Siyuan; He, Lianxiang; Chen, Wenfeng; Jiang, Pinglan; Hu, Yuanping; Chen, Hua
To determine the clinical effect of standardized training and management of peripherally inserted central catheter (PICC) and catheter-related complications. A total of 610 patients were divided into a control group and an observation group, the control group (n=300) were catheterized by trainees who received "short-term intensive training", the observation group (n=310) by "system standardized training and management". The clinical efficacy of catheterization and the rate of catheter-related complications were compared. There was significant difference in the one-time puncture success rate, one-time cannulation success rate, the time for operation and the pain score between the 2 groups (all PPICC training and management can improve the effect of catheterization and reduce the incidence of PICC-related complication.
Saver, Jeffrey L.; Warach, Steven; Janis, Scott; Odenkirchen, Joanne; Becker, Kyra; Benavente, Oscar; Broderick, Joseph; Dromerick, Alexander W.; Duncan, Pamela; Elkind, Mitchell S. V.; Johnston, Karen; Kidwell, Chelsea S.; Meschia, James F.; Schwamm, Lee
Background and Purpose The National Institute of Neurological Disorders and Stroke initiated development of stroke-specific Common Data Elements (CDEs) as part of a project to develop data standards for funded clinical research in all fields of neuroscience. Standardizing data elements in translational, clinical and population research in cerebrovascular disease could decrease study start-up time, facilitate data sharing, and promote well-informed clinical practice guidelines. Methods A Working Group of diverse experts in cerebrovascular clinical trials, epidemiology, and biostatistics met regularly to develop a set of Stroke CDEs, selecting among, refining, and adding to existing, field-tested data elements from national registries and funded trials and studies. Candidate elements were revised based on comments from leading national and international neurovascular research organizations and the public. Results The first iteration of the NINDS stroke-specific CDEs comprises 980 data elements spanning nine content areas: 1) Biospecimens and Biomarkers; 2) Hospital Course and Acute Therapies; 3) Imaging; 4) Laboratory Tests and Vital Signs; 5) Long Term Therapies; 6) Medical History and Prior Health Status; 7) Outcomes and Endpoints; 8) Stroke Presentation; 9) Stroke Types and Subtypes. A CDE website provides uniform names and structures for each element, a data dictionary, and template case report forms (CRFs) using the CDEs. Conclusion Stroke-specific CDEs are now available as standardized, scientifically-vetted variable structures to facilitate data collection and data sharing in cerebrovascular patient-oriented research. The CDEs are an evolving resource that will be iteratively improved based on investigator use, new technologies, and emerging concepts and research findings. PMID:22308239
Full Text Available The aim of this paper is to consider the interaction of tense, mood and focus with negation in Standard Arabic. This interaction can be observed via marking the tense and mood of the sentence, or via selecting a particular type of tense, or being associated with Information Structure. Building on this fact, the current paper provides a unified analysis, in which negation in Arabic can be accounted for without a NegP projection.
Gregersen, Trine Ammentorp; Birkelund, Regner; Ammentorp, Jette
Title: Clinical trial or standard treatment? Shared decision making at the department of oncology. Authors: Ph.d. student, Trine A. Gregersen. Trine.firstname.lastname@example.org. Department of Oncology. Health Services Research Unit Lillebaelt Hospital / IRS University of Southern Denmark. Professor, Regner...... Analyzing field notes: • How to write useful field notes? • How to analyze field notes systematically? • Using Nvivo when analyzing field notes and interviews?...
Biering-Sørensen, Fin; Noonan, Vanessa K
for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged...... to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society's International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements......Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able...
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.
Chung, Soon Cheol; Choi, Do Young; Tack, Gye Rae; Sohn, Jin Hun
The purpose of this study is to establish a reference for image acquisition for completing a standard brain for diverse Korean population, and to develop database management system that saves and manages acquired brain images and personal information of subjects. 3D MP-RAGE (Magnetization Prepared Rapid Gradient Echo) technique which has excellent Signal to Noise Ratio (SNR) and Contrast to Noise Ratio (CNR) as well as reduces image acquisition time was selected for anatomical image acquisition, and parameter values were obtained for the optimal image acquisition. Using these standards, image data of 121 young adults (early twenties) were obtained and stored in the system. System was designed to obtain, save, and manage not only anatomical image data but also subjects' basic demographic factors, medical history, handedness inventory, state-trait anxiety inventory, A-type personality inventory, self-assessment depression inventory, mini-mental state examination, intelligence test, and results of personality test via a survey questionnaire. Additionally this system was designed to have functions of saving, inserting, deleting, searching, and printing image data and personal information of subjects, and to have accessibility to them as well as automatic connection setup with ODBC. This newly developed system may have major contribution to the completion of a standard brain for diverse Korean population since it can save and manage their image data and personal information.
VanDevanter, Donald R; Mayer-Hamblett, Nicole
Evolving cystic fibrosis 'standards of care' have influenced recent cystic fibrosis clinical trial designs for new therapies; care additions/improvements will require innovative trial designs to maximize feasibility and efficacy detection. Three cystic fibrosis therapeutic areas (pulmonary exacerbations, Pseudomonas aeruginosa airway infections, and reduced cystic fibrosis transmembrane conductance regulator [CFTR] protein function) differ with respect to the duration for which recognized 'standards of care' have been available. However, developers of new therapies in all the three areas are affected by similar challenges: standards of care have become so strongly entrenched that traditional placebo-controlled studies in cystic fibrosis populations likely to benefit from newer therapies have become less and less feasible. Today, patients/clinicians are more likely to entertain participation in active-comparator trial designs, that have substantial challenges of their own. Foremost among these are the selection of 'valid' active comparator(s), estimation of a comparator's current clinical efficacy (required for testing noninferiority hypotheses), and effective blinding of commercially available comparators. Recent and future cystic fibrosis clinical trial designs will have to creatively address this collateral result of successful past development of effective cystic fibrosis therapies: patients and clinicians are much less likely to accept simple, placebo-controlled studies to evaluate future therapies.
Poletti, Pierre-Alexandre; Platon, Alexandra; Rutschmann, Olivier T; Schmidlin, Franz R; Iselin, Christophe E; Becker, Christoph D
The purpose of our study was to compare a low-dose abdominal CT protocol, delivering a dose of radiation close to the dose delivered by abdominal radiography, with standard-dose unenhanced CT in patients with suspected renal colic. One hundred twenty-five patients (87 men, 38 women; mean age, 45 years) who were admitted with suspected renal colic underwent both abdominal low-dose CT (30 mAs) and standard-dose CT (180 mAs). Low-dose CT and standard-dose CT were independently reviewed, in a delayed fashion, by two radiologists for the characterization of renal and ureteral calculi (location, size) and for indirect signs of renal colic (renal enlargement, pyeloureteral dilatation, periureteral or renal stranding). Results reported for low-dose CT, with regard to the patients' body mass indexes (BMIs), were compared with those obtained with standard-dose CT (reference standard). The presence of non-urinary tract-related disorders was also assessed. Informed consent was obtained from all patients. In patients with a BMI 3 mm. Low-dose CT was 100% sensitive and specific for depicting non-urinary tract-related disorders (n = 6). Low-dose CT achieves sensitivities and specificities close to those of standard-dose CT in assessing the diagnosis of renal colic, depicting ureteral calculi > 3 mm in patients with a BMI < 30, and correctly identifying alternative diagnoses.
Guo, Jinqiu; Takada, Akira; Niu, Tie; He, Miao; Tanaka, Koji; Sato, Junzo; Suzuki, Muneou; Takahashi, Kiwamu; Daimon, Hiroyuki; Suzuki, Toshiaki; Nakashima, Yusei; Araki, Kenji; Yoshihara, Hiroyuki
CLinical Accounting InforMation (CLAIM) is a standard for the exchange of data between patient accounting systems and electronic medical record (EMR) systems. It uses eXtensible Markup Language (XML) as a meta-language and was developed in Japan. CLAIM is subordinate to the Medical Markup Language (MML) standard, which allows the exchange of medical data between different medical institutions. It has inherited the basic structure of MML 2.x and the current version, version 2.1, contains two modules and nine data definition tables. In China, no data exchange standard yet exists that links EMR systems to accounting systems. Taking advantage of CLAIM's flexibility, we created a localized Chinese version based on CLAIM 2.1. Since Chinese receipt systems differ from those of Japan, some information such as prescription formats, etc. are also different from those in Japan. Two CLAIM modules were re-engineered and six data definition tables were either added or redefined. The Chinese version of CLAIM takes local needs into account, and consequently it is now possible to transfer data between the patient accounting systems and EMR systems of Chinese medical institutions effectively.
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
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.
Zhianpour, M.; Janghorbani, M.
Errors and variations in interpretation can happen in clinical imaging. Few studies have examined the biased effect of clinical information on reporting of brain CT scans. In a blinded double crossover design, we studied whether three radiologists were biased by clinical information when making CT scan diagnosis of the brain. Three consultant radiologists in three rounds with at least a one month interval assessed 100 consecutive cases of brain CT scan. In the first round, clinical information was not available and 100 films without clinical information were given to radiologists. In the second round, the same 100 films were given and true clinical information was available. In the third round, the same 100 films were given and false clinical information was allocated. In 180 cases (60%) the evaluation resulted in the same diagnosis on all three occasions (95% confidence interval (CI): 54.5, 65.5), whereas 120(40%; 95% CI:34.5, 45.5) sets were evaluated differently. 48 cases (16%; 95% CI:11.9,20.1) had discordant evaluation with true and 33 (11%; 95% CI:7.5, 14.5) with false clinical information. Discordance without and with true and false clinical information was 39 (13%; 95% CI:9.2, 16.8). Correct clinical information improves the brain CT report, while the report became less accurate false clinical information was allocated. These results indicate that radiologists are biased by clinical information when reporting brian CT scans
Valentine, D.; Taylor, P.; Zaslavsky, I.
The WaterML 2.0 Standards Working Group (SWG), working within the Open Geospatial Consortium (OGC) and in cooperation with the joint OGC-World Meteorological Organization (WMO) Hydrology Domain Working Group (HDWG), has developed an open standard for the exchange of water observation data; WaterML 2.0. The focus of the standard is time-series data, commonly generated from in-situ style monitoring. This is high value data for hydrological applications such as flood forecasting, environmental reporting and supporting hydrological infrastructure (e.g. dams, supply systems), which is commonly exchanged, but a lack of standards inhibits efficient reuse and automation. The process of developing WaterML required doing a harmonization analysis of existing standards to identify overlapping concepts and come to agreement on a harmonized definition. Generally the formats captured similar requirements, all with subtle differences, such as how time-series point metadata was handled. The in-progress standard WaterML 2.0 incorporates the semantics of the hydrologic information: location, procedure, and observations, and is implemented as an application schema of the Geography Markup Language version 3.2.1, making use of the OGC Observations & Measurements standards. WaterML2.0 is designed as an extensible schema to allow encoding of data to be used in a variety of exchange scenarios. Example areas of usage are: exchange of data for operational hydrological monitoring programs; supporting operation of infrastructure (e.g. dams, supply systems); cross-border exchange of observational data; release of data for public dissemination; enhancing disaster management through data exchange; and exchange in support of national reporting The first phase of WaterML2.0 focused on structural definitions allowing for the transfer of time-series, with less work on harmonization of vocabulary items such as quality codes. Vocabularies from various organizations tend to be specific and take time to
Ahmed, Rami A; Damore, Deborah R; Viti, Joseph F; Hughes, Patrick G; Miesle, Rebecca; Ataya, Ramsey; Atkinson, S Scott; Gable, Brad
We describe a novel means of experiential learning for clinical pastoral care residents using standardized patient (SP) simulations. A prospective cohort study involving 7 clinical pastoral care residents was performed. All residents underwent 2 verbatim SP sessions and 2 simulation sessions. After all sessions, residents completed a self-evaluation. Faculty completed an evaluation and then provided a debriefing session to all residents. Performance ratings were globally higher on simulated scenarios when compared to the verbatim sessions. More research in the field of pastoral care is needed to validate the learned professional skills that enhance a comprehensive training program through the use of medical simulation, verbatim reports, and clinical pastoral education (CPE) competencies. Medical simulation provides a promising teaching methodology for the training of CPE residents. © The Author(s) 2015.
Full Text Available Abstract Background 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. Methods 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. Results 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. Conclusions Dentists have various information needs at the point of care. Among them, the needs
Friedman, Kevin G; Rathod, Rahul H; Farias, Michael; Graham, Dionne; Powell, Andrew J; Fulton, David R; Newburger, Jane W; Colan, Steven D; Jenkins, Kathy J; Lock, James E
A Standardized Clinical Assessment and Management Plan (SCAMP) is a novel quality improvement initiative that standardizes the assessment and management of all patients who carry a predefined diagnosis. Based on periodic review of systemically collected data the SCAMP is designed to be modified to improve its own algorithm. One of the objectives of a SCAMP is to identify and reduce resource utilization and patient care costs. We retrospectively reviewed resource utilization in the first 93 arterial switch operation (ASO) SCAMP patients and 186 age-matched control ASO patients. We compared diagnostic and laboratory testing obtained at the initial SCAMP clinic visit and control patient visits. To evaluate the effect of the SCAMP over time, the number of clinic visits per patient year and echocardiograms per patient year in historical control ASO patients were compared to the projected rates for ASO SCAMP participants. Cardiac magnetic resonance imaging (MRI), stress echocardiogram, and lipid profile utilization were higher in the initial SCAMP clinic visit group than in age-matched control patients. Total echocardiogram and lung scan usage were similar. Chest X-ray and exercise stress testing were obtained less in SCAMP patients. ASO SCAMP patients are projected to have 0.5 clinic visits and 0.5 echocardiograms per year. Historical control patients had more clinic visits (1.2 vs. 0.5 visits/patient year, P<.01) and a higher echocardiogram rate (0.92 vs. 0.5 echocardiograms/patient year, P<.01) Implementation of a SCAMP may initially lead to increased resource utilization, but over time resource utilization is projected to decrease.
Full Text Available The online resource Wikipedia is increasingly used by students for knowledge acquisition and learning. However, the lack of a formal editorial review and the heterogeneous expertise of contributors often results in skepticism by educators whether Wikipedia should be recommended to students as an information source. In this study we systematically analyzed the accuracy and completeness of drug information in the German and English language versions of Wikipedia in comparison to standard textbooks of pharmacology. In addition, references, revision history and readability were evaluated. Analysis of readability was performed using the Amstad readability index and the Erste Wiener Sachtextformel. The data on indication, mechanism of action, pharmacokinetics, adverse effects and contraindications for 100 curricular drugs were retrieved from standard German textbooks of general pharmacology and compared with the corresponding articles in the German language version of Wikipedia. Quantitative analysis revealed that accuracy of drug information in Wikipedia was 99.7% ± 0.2% when compared to the textbook data. The overall completeness of drug information in Wikipedia was 83.8 ± 1.5% (p < 0.001. Completeness varied in-between categories, and was lowest in the category "pharmacokinetics" (68.0% ± 4.2%; p < 0.001 and highest in the category "indication" (91.3% ± 2.0% when compared to the textbook data overlap. Similar results were obtained for the English language version of Wikipedia. Of the drug information missing in Wikipedia, 62.5% was rated as didactically non-relevant in a qualitative re-evaluation study. Drug articles in Wikipedia had an average of 14.6 ± 1.6 references and 262.8 ± 37.4 edits performed by 142.7 ± 17.6 editors. Both Wikipedia and textbooks samples had comparable, low readability. Our study suggests that Wikipedia is an accurate and comprehensive source of drug-related information for undergraduate medical education.
Gutmann, Joanna; Muehlich, Susanne; Zolk, Oliver; Wojnowski, Leszek; Maas, Renke; Engelhardt, Stefan; Sarikas, Antonio
The online resource Wikipedia is increasingly used by students for knowledge acquisition and learning. However, the lack of a formal editorial review and the heterogeneous expertise of contributors often results in skepticism by educators whether Wikipedia should be recommended to students as an information source. In this study we systematically analyzed the accuracy and completeness of drug information in the German and English language versions of Wikipedia in comparison to standard textbooks of pharmacology. In addition, references, revision history and readability were evaluated. Analysis of readability was performed using the Amstad readability index and the Erste Wiener Sachtextformel. The data on indication, mechanism of action, pharmacokinetics, adverse effects and contraindications for 100 curricular drugs were retrieved from standard German textbooks of general pharmacology and compared with the corresponding articles in the German language version of Wikipedia. Quantitative analysis revealed that accuracy of drug information in Wikipedia was 99.7%±0.2% when compared to the textbook data. The overall completeness of drug information in Wikipedia was 83.8±1.5% (ptextbook data overlap. Similar results were obtained for the English language version of Wikipedia. Of the drug information missing in Wikipedia, 62.5% was rated as didactically non-relevant in a qualitative re-evaluation study. Drug articles in Wikipedia had an average of 14.6±1.6 references and 262.8±37.4 edits performed by 142.7±17.6 editors. Both Wikipedia and textbooks samples had comparable, low readability. Our study suggests that Wikipedia is an accurate and comprehensive source of drug-related information for undergraduate medical education. PMID:25250889
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.
Full Text Available Background and objectives : In health centers, clinical information of patient is transferred among care staffs regularly. One of the common cases in information transferring is during the time of nurses’ handover in hospital which performing it correctly will help schedule patient care, providing safety and facilitating exact transferring of information. The aim of this study is investigating validity and reliability of assessment of observance rate of shift handover in clinical wards checklist. Material and Methods : In order to determine the reliability of checklist, two experts panel meetings were held with the presence of 10 experts in clinical field that in those meetings the reliability was investigated with discussion and consensus of participants. Checklist validity was investigated through pilot study in 4 wards of 4 hospitals and calculated by Kronbach- alpha method with 28 cases of shifts handover in morning, noon, and night shift. Results : In studying reliability, the primary checklist was divided into two checklists: patient handover, equipments and ward handover that included 27 and 72 items, respectively. The reliability of patient handover checklist was verified with 0.9155 Kronbach-alpha and that of equipments and ward handover was verified with 0.8779 Kronbach-alpha. Conclusion : Verifying checklists by mentioned scientific and statistical methods showed that these are very powerful instruments that can be used as one of the assessment tools of shift handover in clinical wards to be used towards promoting received services by customers of healthcare system.
Kennelly, R J; Gardner, R M
Automated data capture from bedside patient medical devices is now possible using a new Institute of Electrical and Electronic Engineering (IEEE) and American National Standards Institute (ANSI) Medical Information Bus (MIB) data communications standard (IEEE 1073). The first two standard documents, IEEE 1073.3.1 (Transportation Profile) and IEEE 1073.4.1 (Physical Layer), define the hardware protocol for bedside device communications. With the above noted IEEE MIB standards in place, hospitals can now start designing customized applications for acquiring data from bedside devices such as bedside monitors, i.v. pumps, ventilators, etc. for multiple purposes. The hardware 'plug and play' features of the MIB will enable nurses and physicians to establish communications with these devices simply and conveniently by plugging them into a bedside data connector. No other action will be necessary to establish identification of the device or communications with the device. Presently to connect bedside devices, technical help from hardware and software experts are required to establish such communications links. As a result of standardization of communications, it will be easy to establish a highly mobile network of bedside devices and more promptly and efficiently collect patient related data. Collection of data automatically should lead to the design of new medical computing applications that will tie in directly with the emerging mission and operations of hospitals. The MIB will permit acquisition of patient data more efficiently with greater accuracy, more completeness and more promptly. The above noted features are all essential to the development of computerized treatment protocols and should lead to improved quality of patient care. This manuscript provides the rational and historical overview of the development of the MIB standard.
Kun, Larry E.
Objectives: To review the clinical characteristics of childhood brain tumors, including neurologic signs, neuroimaging and neuropathology. To critically assess indications for therapy relevant to presenting characteristics, age, and disease status. To discuss current management strategies including neurosurgery, radiation therapy, and chemotherapy. To analyze current clinical trials and future directions of clinical research. Brain tumors account for 20% of neoplastic diseases in children. The most common tumors include astrocytoma and malignant gliomas, medulloblastoma and supratentorial PNET's, ependymoma, craniopharyngioma, and intracranial germ cell tumors. Tumor type and clinical course are often correlated with age at presentation and anatomic site. The clinical characteristics and disease extent largely determine the relative merits of available 'standard' and investigational therapeutic approaches. Treatment outcome, including disease control and functional integrity, is dependent upon age at presentation, tumor type, and disease extent. An understanding of the clinical, neuroimaging, and histologic characteristics as they relate to decisions regarding therapy is critical to the radiation oncologist. Appropriate radiation therapy is central to curative therapy for a majority of pediatric brain tumor presentations. Technical advances in neurosurgery provide greater safety for 'gross total resection' in a majority of hemispheric astrocytomas and medulloblastomas. The relative roles of 'standard' radiation therapy and evolving chemotherapy for centrally located astrocytomas (e.g., diencephalic, optic pathway) need to be analyzed in the context of initial and overall disease control, neurotoxicities, and potential modifications in the risk:benefit ratio apparent in the introduction of precision radiation techniques. Modifications in radiation delivery are fundamental to current investigations in medulloblastoma; the rationale for contemporary and projected
Nishizawa, Atsushi; Namikawa, Toshiya; Taruya, Atsushi
Gravitational waves (GWs) from compact binary stars at cosmological distances are promising and powerful cosmological probes, referred to as the GW standard sirens. With future GW detectors, we will be able to precisely measure source luminosity distances out to a redshift z 5. To extract cosmological information, previous studies using the GW standard sirens rely on source redshift information obtained through an extensive electromagnetic follow-up campaign. However, the redshift identification is typically time-consuming and rather challenging. Here we propose a novel method for cosmology with the GW standard sirens free from the redshift measurements. Utilizing the anisotropies of the number density and luminosity distances of compact binaries originated from the large-scale structure, we show that (i) this anisotropies can be measured even at very high-redshifts (z = 2), (ii) the expected constraints on the primordial non-Gaussianity with Einstein Telescope would be comparable to or even better than the other large-scale structure probes at the same epoch, (iii) the cross-correlation with other cosmological observations is found to have high-statistical significance. A.N. was supported by JSPS Postdoctoral Fellowships for Research Abroad No. 25-180.
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.
Clinical information systems (CIS) are developed with the aim of improving both the efficiency and the quality of care. This position paper is based on the hypothesis that such vision is partly a utopian view of the emerging eSociety. Examples are drawn from 15 years of experience with the fully integrated Georges Pompidou University Hospital (HEGP) CIS and temporal data series extracted from the data warehouses of Assistance Publique - Hôpitaux de Paris (AP-HP) acute care hospitals which share the same administrative organization as HEGP. Three main virtuous circles are considered: user satisfaction vs. system use, system use vs. cost efficiency, and system use vs quality of care. In structural equation models (SEM), the positive bidirectional relationship between user satisfaction and use was only observed in the early HEGP CIS deployment phase (first four years) but disappeared in late post-adoption (≥8 years). From 2009 to 2013, financial efficiency of 20 AP-HP hospitals evaluated with stochastic frontier analysis (SFA) models diminished by 0.5% per year. The lower decrease of efficiency observed between the three hospitals equipped with a more mature CIS and the 17 other hospitals was of the same order of magnitude than the difference observed between pediatric and non-pediatric hospitals. Outcome quality benefits that would bring evidence to the system use vs. quality loop are unlikely to be obtained in a near future since they require integration with population-based outcome measures including mortality, morbidity, and quality of life that may not be easily available. Barriers to making the transformation of the utopian part of the CIS virtuous circles happen should be overcome to actually benefit the emerging eSociety.
Slama, Alexis; Schillab, Lukas; Barta, Maximilian; Benedek, Aris; Mitterbauer, Andreas; Hoetzenecker, Konrad; Taghavi, Shahrokh; Lang, Gyoergy; Matilla, Jose; Ankersmit, Hendrik; Hager, Helmut; Roth, Georg; Klepetko, Walter; Aigner, Clemens
Ex vivo lung perfusion (EVLP) was primarily developed for evaluation of impaired donor lungs. The good clinical results raise the question for its possible impact on lungs meeting standard criteria. Before application of EVLP on such lungs enters routine clinical practice, it must be demonstrated whether EVLP would affect or improve outcome when used in standard donor lungs. We performed a prospective randomized trial to investigate the role of EVLP in standard lung transplantation (Tx). This prospective randomized clinical trial compared patients who underwent Tx with ex vivo evaluated donor lungs with an equivalent patient population without previous EVLP. From October 2013 to May 2015, 193 lung Tx were performed at the Medical University of Vienna. During this period, 80 recipient/donor pairs that met the inclusion criteria were included in this trial, 41 pairs in the control group, and 39 in the EVLP group. In the EVLP group, 4 lungs (10.2%) ultimately did not qualify for Tx and were rejected for lung Tx owing to technical reasons (n = 2) and quality criteria (n = 2). Donor and recipient characteristics were comparable in both groups. Total cold ischemic time in the EVLP group was significantly longer for both implanted lungs (first side, 372 minutes vs 291 minutes, p 1 was lower in the EVLP group at all time points compared with the control group (24 hours, 5.7% vs 19.5%, p = 0.10), and need for post-operative prolonged extracorporeal membrane oxygenation was lower in the EVLP group (5.7% vs 12.2%, p = 0.44). Short-term clinical outcomes did not differ between recipients in the 2 groups. Patients remained intubated (1.6 days vs 1.6 days, p = 0.67), in the intensive care unit (6 days vs 6 days, p = 0.76), and in the hospital (23 days vs 19 days, p = 0.42) for a comparable period of time. The 30-day survival was 97.1% vs 100% (p = 0.46). This study provides evidence that EVLP can safely be used in standard donor lungs. Functional results and perioperative
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
Nikolenko Nataliya V.
Full Text Available The article identifies the degree of correspondence of the national Provisions (Standard of Business Accounting (PSBA Lease with the international standard and provides recommendations with respect to their closing up. On the results of the study the author provides specific features of international and national standards – the existing IFRS 17 Lease and national PSBA 14 Lease by the following components: definition of lease, its classification and reflection in accounting. Also the text of PSBA 31 Financial Expenditures is supplemented with provisions on capitalisation of financial expenditures prospectively, which would allow avoidance of correction of the balance of the retained income and provision of comparative information for previous periods. The article provides an algorithm of division of lease for accounting purposes on the basis of international standards. Its use would ensure correctness of reflection of lease operations in accounting and would serve as a basis for development of methodical provisions with respect to accounting. By the result of the study the author forms definition of the qualification asset as an asset which requires considerable time for its creation, preparation for target use, sales or acquisition of the ownership right. Capitalisation of such expenditures would allow non-reduction of the accounting income and also would provide a possibility to reflect financial expenditures in accordance with their economic essence.
Cresswell, Kathrin; Morrison, Zoe; Kalra, Dipak; Sheikh, Aziz
We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined.
Cresswell, Kathrin; Morrison, Zoe; Sheikh, Aziz; Kalra, Dipak
Background We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Materials and Methods Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Results Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. Conclusions There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined. PMID:22937106
Hansen, Tomas; Wikstroem, Johan; Eriksson, Mats-Ola; Lundberg, Anders; Ahlstroem, Haakan [Uppsala University Hospital, Department of Diagnostic Radiology, Uppsala (Sweden); Johansson, Lars [Uppsala University Hospital, Uppsala (Sweden); Ljungman, Christer [Uppsala University Hospital, Department of Vascular Surgery, Uppsala (Sweden); Hoogeven, Romhild [Philips Medical Systems, MR Clinical Science, Best (Netherlands)
The purpose of this study was to evaluate the technique of whole-body magnetic resonance angiography (MRA) of patients with a standard clinical scanner. Thirty-three patients referred for stenoses, occlusions, aneurysms, assessment of patency of vascular grafts, vasculitis and vascular aplasia were examined in a 1.5-T scanner using its standard body coil. Three-dimensional sequences were acquired in four stations after administration of one intravenous injection of 40 ml conventional gadolinium contrast agent. Different vessel segments were evaluated as either diagnostic or nondiagnostic and regarding the presence of stenoses with more than 50% diameter reduction, occlusions or aneurysms. Of 923 vessel segments, 67 were not evaluable because of poor contrast filling (n=31), motion artefacts (n=20), venous overlap (n=12) and other reasons (n=4). Stenoses of more than 50%, occlusions or aneurysms were observed in 26 patients (129 segments). In nine patients additional unsuspected pathology was found. In 10 out of 14 patients (71/79 segments) there was conformity between MRA and digital subtraction angiography regarding the grade of stenosis. This study shows that whole-body MRA with a standard clinical scanner is feasible. Motion artefacts and the timing of the contrast agent through the different segments are still problems to be solved. (orig.)
Huang, Ean-Wen; Hung, Rui-Suan; Chiou, Shwu-Fen; Liu, Fei-Ying; Liou, Der-Ming
Information and communication technologies progress rapidly and many novel applications have been developed in many domains of human life. In recent years, the demand for healthcare services has been growing because of the increase in the elderly population. Consequently, a number of healthcare institutions have focused on creating technologies to reduce extraneous work and improve the quality of service. In this study, an information platform for tele- healthcare services was implemented. The architecture of the platform included a web-based application server and client system. The client system was able to retrieve the blood pressure and glucose levels of a patient stored in measurement instruments through Bluetooth wireless transmission. The web application server assisted the staffs and clients in analyzing the health conditions of patients. In addition, the server provided face-to-face communications and instructions through remote video devices. The platform deployed a service-oriented architecture, which consisted of HL7 standard messages and web service components. The platform could transfer health records into HL7 standard clinical document architecture for data exchange with other organizations. The prototyping system was pretested and evaluated in a homecare department of hospital and a community management center for chronic disease monitoring. Based on the results of this study, this system is expected to improve the quality of healthcare services.
Dawson, Liza; Zwerski, Sheryl
This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.
McKenzie, Carly T; Tilashalski, Ken R; Peterson, Dawn Taylor; White, Marjorie Lee
The aim of this study was to investigate dental students' long-term retention of clinical communication skills learned in a second-year standardized patient simulation at one U.S. dental school. Retention was measured by students' performance with an actual patient during their fourth year. The high-fidelity simulation exercise focused on clinical communication skills took place during the spring term of the students' second year. The effect of the simulation was measured by comparing the fourth-year clinical performance of two groups: those who had participated in the simulation (intervention group; Class of 2016) and those who had not (no intervention/control group; Class of 2015). In the no intervention group, all 47 students participated; in the intervention group, 58 of 59 students participated. Both instructor assessments and students' self-assessments were used to evaluate the effectiveness of key patient interaction principles as well as comprehensive presentation of multiple treatment options. The results showed that students in the intervention group more frequently included cost during their treatment option presentation than did students in the no intervention group. The instructor ratings showed that the intervention group included all key treatment option components except duration more frequently than did the no intervention group. However, the simulation experience did not result in significantly more effective student-patient clinical communication on any of the items measured. This study presents limited evidence of the effectiveness of a standardized patient simulation to improve dental students' long-term clinical communication skills with respect to thorough presentation of treatment options to a patient.
Efstathios D Kondylis
Full Text Available High frequency oscillations (HFOs have been proposed as a novel marker for epileptogenic tissue, spurring tremendous research interest into the characterization of these transient events. A wealth of continuously recorded intracranial electroencephalographic (iEEG data is currently available from patients undergoing invasive monitoring for the surgical treatment of epilepsy. In contrast to data recorded on research-customized recording systems, data from clinical acquisition systems remain an underutilized resource for HFO detection in most centers. The effective and reliable use of this clinically obtained data would be an important advance in the ongoing study of HFOs and their relationship to ictogenesis. The diagnostic utility of HFOs ultimately will be limited by the ability of clinicians to detect these brief, sporadic, and low amplitude events in an electrically noisy clinical environment. Indeed, one of the most significant factors limiting the use of such clinical recordings for research purposes is their low signal to noise ratio, especially in the higher frequency bands. In order to investigate the presence of HFOs in clinical data, we first obtained continuous intracranial recordings in a typical clinical environment using a commercially available, commonly utilized data acquisition system and off the shelf hybrid macro/micro depth electrodes. This data was then inspected for the presence of HFOs using semi-automated methods and expert manual review. With targeted removal of noise frequency content, HFOs were detected on both macro- and micro-contacts, and preferentially localized to seizure onset zones. HFOs detected by the offline, semi-automated method were also validated in the clinical viewer, demonstrating that 1 this clinical system allows for the visualization of HFOs, and 2 with effective signal processing, clinical recordings can yield valuable information for offline analysis.
Yaqub, Mohammad; Kelly, Brenda; Papageorghiou, Aris T; Noble, J Alison
During routine ultrasound assessment of the fetal brain for biometry estimation and detection of fetal abnormalities, accurate imaging planes must be found by sonologists following a well-defined imaging protocol or clinical standard, which can be difficult for non-experts to do well. This assessment helps provide accurate biometry estimation and the detection of possible brain abnormalities. We describe a machine-learning method to assess automatically that transventricular ultrasound images of the fetal brain have been correctly acquired and meet the required clinical standard. We propose a deep learning solution, which breaks the problem down into three stages: (i) accurate localization of the fetal brain, (ii) detection of regions that contain structures of interest and (iii) learning the acoustic patterns in the regions that enable plane verification. We evaluate the developed methodology on a large real-world clinical data set of 2-D mid-gestation fetal images. We show that the automatic verification method approaches human expert assessment. Copyright © 2017 World Federation for Ultrasound in Medicine and Biology. Published by Elsevier Inc. All rights reserved.
Lisa Doyle Howley, PhD
Full Text Available Introduction. The purpose of the current study was to investigate the effects of oral feedback from standardized patients on medical students’ overall perceptions of an educational exercise. We chose a mixed-methods approach to better understand the following research questions: Does satisfaction with the standardized patient exercise differ among those students who receive oral feedback and those who do not? What is the quality of oral feedback provided by standardized patients? Procedures. In order to address the first question, a basic randomized design comparing treatment (or those receiving SP feedback to control (those not receiving SP feedback was conducted. To address the second question, students in the treatment group were surveyed about their impressions of the quality of the feedback provided to them by their SP. One hundred and thirty six first year medical students were divided into treatment and control groups and interviewed one standardized patient during a single 20-minute encounter. Standardized patients were trained to simulate one of two outpatient cases and provide feedback using standard training materials. Both treatment and control groups completed a rating scale and questionnaire regarding their satisfaction with the encounter and students in the treatment group responded to additional questions regarding the quality of the SP feedback. Results. A one-way multivariate analysis of variance (MANOVA revealed significant differences among control and treatment groups on the seven combined dependent variables, Wilks’ =.890, F(7, 127=2.25, p<.034, ?2=.110. Students reported that the quality of SP feedback was very strong and additional qualitative analysis revealed further evidence to support the efficacy of providing oral SP feedback in a formative pre-clinical educational activity.
Santos, M R; de Sá, T Q V; da Silva, F E; Dos Santos Junior, M R; Maia, T A; Reis, Z S N
Background Around the world, people receive care at various institutions; therefore, clinical information is recorded either on paper or distributed on different information systems with reduced capabilities for sharing data. One approach to handling the complex nature of the health information systems and making it interoperable is the two-level modeling, and the ISO 13606 standard is an option to support this model. A regionally governed EHR program in Brazil proposed to use the ISO 13606 standard and archetypes. This program includes an EHR repository for consolidating the longitudinal electronic record of patients' health. Objective This article aims to present the results and lessons learned from a proof-of-concept (POC) for integrating the Maternal and Neonatal Healthcare Information System (SISMater) developed by the Federal University of Minas Gerais (UFMG) with the EHR system developed by the Department of Healthcare for the State of Minas Gerais (SES/MG). Methods The design of the architecture and software development were driven by the content to be exchanged between the SISMater system and the EHR system and the usage of XML transformation to translate an ISO 13606 EHR extract and vice versa. This POC did not include tests related to revision objects according to ISO 13606 reference model. Results The software architecture and software components required for this POC were proposed and tested. The EHR system validated the syntax and semantic and persisted the extract in the EHR repository. Complete results can be accessed at https://github.com/pocppsus/repository. Conclusion The approach for using XML transformations could make easier the process for ISO 13606 noncompliant EMR systems to exchange EHR data with the SES/MG EHR system.
Marouf, Fatma E; Esplin, Bryn S
For the past few decades, there has been intense debate in bioethics about the standard of care that should be provided in clinical trials conducted in developing countries. Some interpret the Declaration of Helsinki to mean that control groups should receive the best intervention available worldwide, while others interpret this and other international guidelines to mean the best local standard of care. Questions of justice are particularly relevant where limited resources mean that the local standard of care is no care at all. Introducing human rights law into this complex and longstanding debate adds a new and important perspective. Through non-derogable rights, including the core obligations of the right to health, human rights law can help set a minimum standard of care. Copyright 2015 Marouf and Esplin. This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited.
Smith, Sue; Hawker, Jeremy I; Smith, Gillian E; Morbey, Roger; Johnson, Alan P; Fleming, Douglas M; Shallcross, Laura; Hayward, Andrew C
A key component of strategies to reduce antimicrobial resistance is better antimicrobial prescribing. The majority of antibiotics are prescribed in primary care. While many existing surveillance systems can monitor trends in the quantities of antibiotics prescribed in this setting, it can be difficult to monitor the quality of prescribing as data on the condition for which prescriptions are issued are often not available. We devised a standardized methodology to facilitate the monitoring of condition-specific antibiotic prescribing in primary care. We used a large computerized general practitioner database to develop a standardized methodology for routine monitoring of antimicrobial prescribing linked to clinical indications in primary care in the UK. Outputs included prescribing rate by syndrome and percentages of consultations with antibiotic prescription, for recommended antibiotic, and of recommended treatment length. The standardized methodology can monitor trends in proportions of common infections for which antibiotics were prescribed, the specific drugs prescribed and duration of treatment. These data can be used to help assess the appropriateness of antibiotic prescribing and to assess the impact of prescribing guidelines. We present a standardized methodology that could be applied to any suitable national or local database and adapted for use in other countries. © Crown copyright 2017.
Tonon, Caroline C; Paschoal, Marco Aurélio; Correia, Marilia; Spolidório, Denise M P; Bagnato, Vanderlei S; Giusti, Juçaíra S M; Santos-Pinto, Lourdes
The aim of this study was investigate the effect of photodynamic therapy (PDT) using curcumin (C) as a photosensitizing agent irradiated with an LED (L) in the blue wavelength as a light source on a standard and clinical isolate of Streptococcus mutans (S. mutans) in a planktonic suspension model. Suspensions of both strains were divided into 4 groups as follows: absence of C and L (control group: C-L-), with C and without L (C group: C+L-), absence of C with L (L group: C-L+) and presence of C and L (PDT group: C+L+). Three different concentrations of curcumin (0.75 mg/ml, 1.5 mg/ml and 3 mg/ml) and three light fluences of studied light source (24, 48 and 72 J cm(-2)) were tested. Aliquots of each studied group was plated in BHI agar and submitted to colony forming units counting (CFU/ml) and the data transformed into logarithmical scale. A high photoinactivation rate of more than 70% was verified to standard S. mutans strain submitted to PDT whereas the clinical isolate showed a lower sensitivity to all the associations of curcumin and LED. A slight bacterial reduction was verified to C+L- and C-L+, demonstrating no toxic effects to the isolated application of light and photosensitizer to both S. mutans strains tested. Photodynamic therapy using a combination of curcumin and blue LED presented a substantial antimicrobial effect on S. mutans standard strain in a planktonic suspension model with a less pronounced effect on its clinical isolate counterparts due to resistance to this alternative approach. Alternative antimicrobial approaches, as photodynamic therapy, should be encouraged due to optimal results against cariogenic bacteria aiming to prevent or treat dental caries.
Ashish Kumar Singh
Full Text Available Background: Staphylococcus aureus is Gram-positive bacterium commonly associated with nosocomial infections. The development of biofilm exhibiting drug resistance especially in foreign body associated infections has enabled the bacterium to draw considerable attention. However, till date, consensus guidelines for in vitro biofilm quantitation and categorization criterion for the bacterial isolates based on biofilm-forming capacity are lacking. Therefore, it was intended to standardize in vitro biofilm formation by clinical isolates of S. aureus and then to classify them on the basis of their biofilm-forming capacity. Materials and Methods: A study was conducted for biofilm quantitation by tissue culture plate (TCP assay employing 61 strains of S. aureus isolated from clinical samples during May 2015– December 2015 wherein several factors influencing the biofilm formation were optimized. Therefore, it was intended to propose a biofilm classification criteria based on the standard deviation multiples of the control differentiating them into non, low, medium, and high biofilm formers. Results: Brain-heart infusion broth was found to be more effective in biofilm formation compared to trypticase soy broth. Heat fixation was more effective than chemical fixation. Although, individually, glucose, sucrose, and sodium chloride (NaCl had no significant effect on biofilm formation, a statistically significant increase in absorbance was observed after using the supplement mix consisting of 222.2 mM glucose, 116.9 mM sucrose, and 1000 mM NaCl (P = 0.037. Conclusions: The present study puts forth a standardized in vitro TCP assay for biofilm biomass quantitation and categorization criteria for clinical isolates of S. aureus based on their biofilm-forming capacity. The proposed in vitro technique may be further evaluated for its usefulness in the management of persistent infections caused by the bacterium.
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
Krämer, K L; Clauss, M
In order to get a better data management of complications in orthopedic surgery and in order to get comparable statistics a standardisation of nomenclature and classification of complications is demanded since 1.1.1997. The Orthopedic University Clinic of Heidelberg started with a register of all early complications of all inpatients. According to a standardized nomenclature all occurred complications the doctors put in the data of complications in a database. These data were controlled, complemented and classified by members of the quality management group. This guideline consists of five parts: catalogue of diagnoses, general and special definitions, classification and an allocation table of diagnoses to grades of severity.
Infusino, Ilenia; Schumann, Gerhard; Ceriotti, Ferruccio; Panteghini, Mauro
The goal of standardization for measurement of the catalytic concentration of enzymes is to achieve comparable results in human samples, independent of the reagent kits, instruments, and laboratory where the assay is performed. To pursue this objective, the IFCC has established reference systems for the most important clinical enzymes. These systems are based on the following requirements: a) reference methods, well described and evaluated extensively; b) suitable reference materials; and c) reference laboratories operating in a highly controlled manner. When these reference systems are used appropriately, the diagnostic industry can assign traceable values to commercial calibrators. Clinical laboratories that use procedures with validated calibrators to measure human specimens can now obtain values that are traceable to higher-order reference procedures. These reference systems constitute the structure of the traceability chain to which the routine methods can be linked via an appropriate calibration process, provided that they have a comparable specificity (i.e., they are measuring the same catalytic quantity).
Full Text Available The new age clinical research professional is now geared toward an "integrated monitoring" approach. A number of critical activities at the site level and at the sponsor′s organization need convergence to harness rich dividends in early study start and quick close of the study. The field monitor needs full integration to ensure standard of care, train the site in protocol, select the right site, ensure regulatory support, ensure excellent project management skills, coach, support the logistics team, manage the vendor, ensure good documentation practices, develop patient recruitment and retention, lean the applicable process, as well as ensure effective site management amongst the myriad activities assigned toward developing the drug in the clinic.
Kuang, Jinqiu; Mohanty, April F; Rashmi, V H; Weir, Charlene R; Bray, Bruce E; Zeng-Treitler, Qing
Patient-reported functional status is widely recognized as an important patient-centered outcome that adds value to medical care, research, and quality improvement. Functional status outcomes are, however, not routinely or uniformly collected in the medical record, except in certain small patient populations (e.g. geriatrics, nursing home residents). To utilize patient reported functional status for clinical research and practice, we manually collected 2,763 terms from clinical records and social media sites and modeled them on the widely used Short Form-36 Health Survey. We then examined the coverage of the Unified Medical Language System (UMLS) for these functional status terms through automated mapping. Most terms (85.9%) did not have exact matches in the UMLS. The partial matches were prevalent, however, they typically did not capture the terms' exact semantics. Our study suggests that there is a need to extend existing standard terminologies to incorporate functional status terms used by patients and clinicians.
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…
Gries, C.; Vanderbilt, K.; Reid, D.; Melendez-Colom, E.; San Gil, I.
Over the last five years several Long-Term Ecological Research (LTER) sites have collaboratively developed a standardized yet flexible approach to ecological information management based on the open source Drupal content management system. These LTER sites adopted a common data model for basic metadata necessary to describe data sets, but also used for site management and web presence. Drupal core functionality provides web forms for easy management of information stored in this data model. Custom Drupal extensions were developed to generate XML files conforming to the Ecological Metadata Language (EML) for contribution to the LTER Network Information System (NIS) and other data archives. Each LTER site then took advantage of the flexibility Drupal provides to develop its unique web presence, choosing different themes and adding additional content to the websites. By nature, information presented is highly interlinked which can easily be modeled in Drupal entities and is further supported by a sophisticated tagging system (Fig. 1). Therefore, it is possible to provide the visitor with many different entry points to the site specific information presented. For example, publications and datasets may be grouped for each scientist, for each research project, for each major research theme at the site, making the information presented more accessible for different visitors. Experience gained during the early years was recently used to launch a complete re-write for upgrading to Drupal 7. LTER sites from multiple academic institutions pooled resources in order to partner with professional Drupal developers. Highlights of the new developments are streamlined data entry, improved EML output and integrity, support of IM workflows, a faceted data set search, a highly configurable data exploration tool with intelligent filtering and data download, and, for the mobile age, a responsive web design theme. Seven custom modules and a specific installation profile were developed
Simberloff, Tander; Parambi, Ron; Bartnikas, Lisa M; Broyles, Ana Dioun; Hamel, Victoria; Timmons, Karol G; Miller, D Marlowe; Graham, Dionne A; Schneider, Lynda C; MacGinnitie, Andrew J
Oral food challenges (OFCs) are routinely used to confirm ongoing food allergy. Serum-specific IgE (sIgE) and skin prick testing (SPT) are imperfect predictors of which patients will pass OFCs. The objective of this study was to describe the design and implementation of a Standardized Clinical Assessment and Management Plan (SCAMP) to study and iteratively improve sIgE and SPT thresholds to determine when and where to conduct OFCs for patients. Allergists consulted recommended sIgE and SPT thresholds when ordering challenges although diversions were permitted. Criteria were iteratively improved after periodic analyses of challenge outcome and diversions. Over 3 years, allergists ordered 2368 food challenges for 1580 patients with histories of IgE-mediated reactions to food: 1386 in an outpatient clinic and 945 in a higher resource infusion center. Reactions to challenge were observed in 13% of clinic and 23% of infusion center challenges. Six patients challenged in clinic required treatment with epinephrine compared with 22 in the infusion center. The need for epinephrine was more common in patients with asthma-5% of asthmatic patients required epinephrine compared with 1% of nonasthmatic patients (P challenges ordered in the higher resource location. By setting and continually refining sIgE and SPT recommendations using the SCAMP method, allergists can better determine the risk of severe reaction and triage patients to the appropriate setting for an OFC. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
Sullivan, Kathleen; Pantazopoulos, Harry; Liebson, Elizabeth; Woo, T-U W; Baldessarini, Ross J; Hedreen, John; Berretta, Sabina
Postmortem studies on the human brain reside at the core of investigations on neurologic and psychiatric disorders. Ground-breaking advances continue to be made on the pathologic basis of many of these disorders, at molecular, cellular, and neural connectivity levels. In parallel, there is increasing emphasis on improving methods to extract relevant demographic and clinical information about brain donors and, importantly, translate it into measures that can reliably and effectively be incorporated in the design and data analysis of postmortem human investigations. Here, we review the main source of information typically available to brain banks and provide examples on how this information can be processed. In particular, we discuss approaches to establish primary and secondary diagnoses, estimate exposure to therapeutic treatment and substance abuse, assess agonal status, and use time of death as a proxy in investigations on circadian rhythms. Although far from exhaustive, these considerations are intended as a contribution to ongoing efforts from tissue banks and investigators aimed at establishing robust, well-validated methods for collecting and standardizing information about brain donors, further strengthening the scientific rigor of human postmortem studies. Copyright © 2018 Elsevier B.V. All rights reserved.
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.
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.
Werven, Michiel J.N. van; Nooij, Michiel de; Scheepers, Martin J.J.
The adequacy of supply standard is ultimately based on a loss of load probability in combination with assumptions about the extent to which the national system can count on assistance of adjoining electricity supply systems during times of shortages. It can be used to calculate the required generation capacity in an ex-ante market analysis using different future scenarios. This standard in combination with monitoring of (future) market developments on the basis of several market indicators, can give a signal to market participants with respect to the expected adequacy of supply in the longer term. Market participants are informed about the actual and expected future status of adequacy of supply in the market. It is, however, very important that the assessment and the resulting signal should not be used by the government to intervene in the market, but only to improve market transparency and assist producers, suppliers, and consumers in their decisions towards an effective and efficient response on long-term market developments. Specific policy measures based on the monitoring results could provoke strategic behaviour of market participants. The signalising standard might be a powerful instrument in helping to solve the generation adequacy problem. This solution can be seen as a compromise between options that fully rely on an optimal response by the free electricity market and options where governments take the full responsibility
Brown, E.; Cory, K.; Arent, D.
Renewable fuels standard (RFS) policies are becoming a popular public policy mechanism for developing the market for renewable fuels in the transportation sector. During the past decade, U.S. states and several countries began implementing these more market-based (less command and control) policies to support increased biofuels production and use. This paper presents an overview of current and proposed U.S. state-level policies, as well as selected electric sector policies and international fuel standard policies. Current U.S. state-level renewable fuel policies list drivers including an improved economy and environment, as well as fuel self-sufficiency. Best practices and experience from an evaluation of renewable portfolio standards (RPS) in the United States and international RFS policies can inform U.S. state-level policy by illustrating the importance of policy flexibility, binding targets, effective cost caps, and tradable permits. Understanding and building on the experiences from these previous policies can improve the policy mechanism and further develop a market for renewable fuels to meet the goals of improved economy, environment, and fuel self-sufficiency.
Schaverien, M V; Doughty, J C; Stallard, S
The aim of this systematic review was to establish the completeness of reporting of key patient, tumour, treatment, and outcomes information in the randomized-controlled trials (RCTs) of standard breast-conserving surgery (sBCS) considered to be the 'gold-standard', and to compare this with the reporting of the same key criteria for all published studies of oncoplastic breast-conserving surgery (oBCS). Pubmed (1966 to 1st April 2013), Ovid MEDLINE (1966 to 1st April 2013), EMBASE (1980 to 1st April 2013), and the Cochrane Database of Systematic Reviews (Issue 4, 2013) were searched separately for the following terms: (i) 'oncoplastic AND breast AND surgery'; and (ii) 'therapeutic AND mammaplasty'. Only English language and full text articles were reviewed. Following a pilot evaluation of all studies, key reporting criteria were identified. 16 RCTs of sBCS (n = 11,767 patients) were included, and 53 studies met the inclusion criteria for oncoplastic BCS (n = 3236 patients), none of which were RCTs. No study reported all of the criteria identified, with a mean of 64% of key criteria (range, 55-75%) reported in studies of sBCS, and 54% of criteria (range, 10-85%) reported in studies of oBCS. It is therefore evident that there is much room for improvement in the quality of reporting is BCS studies. Standards are proposed to give future studies of BCS a framework for reporting key information and outcomes. Copyright © 2013 Elsevier Ltd. All rights reserved.
Full Text Available Abstract Background This study evaluates the preoperative conventional anteroposterior radiography and clinical testing in non-operated patients with cuff tear arthropathy. It analyses the radiological findings in relation to the status of the rotator cuff and clinical status as also the clinical testing in relation to the rotator cuff quality. The aim of the study is to define the usefulness of radiography and clinical examination in cuff tear arthropathy. Methods This study analyses the preoperative radiological (AP-view, (Artro-CT-scan or MRI-scan and clinical characteristics (Constant-Murley-score plus active and passive mobility testing and the peroperative findings in a cohort of 307 patients. These patients were part of a multicenter, retrospective, consecutive study of the French Orthopaedic Society (SOFCOT-2006. All patients had no surgical antecedents and were all treated with prosthetic shoulder surgery for a painful irreparable cuff tear arthropathy (reverse-(84% or hemi-(8% or double cup-bipolar prosthesis (8%. Results A positive significancy could be found for the relationship between clinical testing and the rotator cuff quality; between acromiohumeral distance and posterior rotator cuff quality; between femoralization and posterior rotator cuff quality. Conclusion A conventional antero-posterior radiograph can not provide any predictive information on the clinical status of the patient. The subscapular muscle can be well tested by the press belly test and the teres minor muscle can be well tested by the hornblower' sign and by the exorotation lag signs. The upward migration index and the presence of femoralization are good indicators for the evaluation of the posterior rotator cuff. An inferior coracoid tip positioning suggests rotator cuff disease.
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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...
Barbarito, Fulvio; Pinciroli, Francesco; Mason, John; Marceglia, Sara; Mazzola, Luca; Bonacina, Stefano
Information technologies (ITs) have now entered the everyday workflow in a variety of healthcare providers with a certain degree of independence. This independence may be the cause of difficulty in interoperability between information systems and it can be overcome through the implementation and adoption of standards. Here we present the case of the Lombardy Region, in Italy, that has been able, in the last 10 years, to set up the Regional Social and Healthcare Information System, connecting all the healthcare providers within the region, and providing full access to clinical and health-related documents independently from the healthcare organization that generated the document itself. This goal, in a region with almost 10 millions citizens, was achieved through a twofold approach: first, the political and operative push towards the adoption of the Health Level 7 (HL7) standard within single hospitals and, second, providing a technological infrastructure for data sharing based on interoperability specifications recognized at the regional level for messages transmitted from healthcare providers to the central domain. The adoption of such regional interoperability specifications enabled the communication among heterogeneous systems placed in different hospitals in Lombardy. Integrating the Healthcare Enterprise (IHE) integration profiles which refer to HL7 standards are adopted within hospitals for message exchange and for the definition of integration scenarios. The IHE patient administration management (PAM) profile with its different workflows is adopted for patient management, whereas the Scheduled Workflow (SWF), the Laboratory Testing Workflow (LTW), and the Ambulatory Testing Workflow (ATW) are adopted for order management. At present, the system manages 4,700,000 pharmacological e-prescriptions, and 1,700,000 e-prescriptions for laboratory exams per month. It produces, monthly, 490,000 laboratory medical reports, 180,000 radiology medical reports, 180
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.
Kotsianos-Hermle, D. [Department of Clinical Radiology, University of Munich (Germany)], E-mail: email@example.com; Wirth, S.; Fischer, T. [Department of Clinical Radiology, University of Munich (Germany); Hiltawsky, K.M. [General Electric, Global Research, Garching (Germany); Reiser, M. [Department of Clinical Radiology, University of Munich (Germany)
Objectives: The feasibility, image quality, and diagnostic potential of the prototype of an automated ultrasound (US) breast scanner were examined. Methods: Ninety-seven patients with suspicious breast lesions had mammograms, manual US, and an automated breast US. The data were evaluated according to the breast imaging reporting and data system (BIRADS) classification, image quality, and amount to diagnostic information. All lesions were confirmed histological. Results: The image quality of the three-dimensional (3D) data sets was equal to or satisfactory compared with cross-sectional images from manual US in at least 72% of cases (p < 0.05). The diagnostic information was equal or superior in at least 63% of cases (p < 0.05). Conclusions: Standardized 3D US scanning is a promising diagnostic adjunct to mammography, but is no substitute for manual US at the current stage of development.
Full Text Available Advances made in genetic testing and tools applied to pharmacogenetics are increasingly being used to inform clinicians in fields such as oncology, hematology, diabetes (endocrinology, cardiology and expanding into psychiatry by examining the influences of genetics on drug efficacy and metabolism. We present a clinical case example of an adolescent male with anxiety, attention deficit hyperactivity disorder (ADHD and autism spectrum disorder who did not tolerate numerous medications and dosages over several years in attempts to manage his symptoms. Pharmacogenetics testing was performed and DNA results on this individual elucidated the potential pitfalls in medication use because of specific pharmacodynamic and pharmacokinetic differences specifically involving polymorphisms of genes in the cytochrome p450 enzyme system. Future studies and reports are needed to further illustrate and determine the type of individualized medicine approach required to treat individuals based on their specific gene patterns. Growing evidence supports this biological approach for standard of care in psychiatry.
Sargeant, Joan; Eva, Kevin W; Armson, Heather; Chesluk, Ben; Dornan, Tim; Holmboe, Eric; Lockyer, Jocelyn M; Loney, Elaine; Mann, Karen V; van der Vleuten, Cees P M
Conceptualisations of self-assessment are changing as its role in professional development comes to be viewed more broadly as needing to be both externally and internally informed through activities that enable access to and the interpretation and integration of data from external sources. Education programmes use various activities to promote learners' reflection and self-direction, yet we know little about how effective these activities are in 'informing' learners' self-assessments. This study aimed to increase understanding of the specific ways in which undergraduate and postgraduate learners used learning and assessment activities to inform self-assessments of their clinical performance. We conducted an international qualitative study using focus groups and drawing on principles of grounded theory. We recruited volunteer participants from three undergraduate and two postgraduate programmes using structured self-assessment activities (e.g. portfolios). We asked learners to describe their perceptions of and experiences with formal and informal activities intended to inform self-assessment. We conducted analysis as a team using a constant comparative process. Eighty-five learners (53 undergraduate, 32 postgraduate) participated in 10 focus groups. Two main findings emerged. Firstly, the perceived effectiveness of formal and informal assessment activities in informing self-assessment appeared to be both person- and context-specific. No curricular activities were considered to be generally effective or ineffective. However, the availability of high-quality performance data and standards was thought to increase the effectiveness of an activity in informing self-assessment. Secondly, the fostering and informing of self-assessment was believed to require credible and engaged supervisors. Several contextual and personal conditions consistently influenced learners' perceptions of the extent to which assessment activities were useful in informing self-assessments of
Gézero, L.; Antunes, C.
In the last few years, LiDAR sensors installed in terrestrial vehicles have been revealed as an efficient method to collect very dense 3D georeferenced information. The possibility of creating very dense point clouds representing the surface surrounding the sensor, at a given moment, in a very fast, detailed and easy way, shows the potential of this technology to be used for cartography and digital terrain models production in large scale. However, there are still some limitations associated with the use of this technology. When several acquisitions of the same area with the same device, are made, differences between the clouds can be observed. The range of that differences can go from few centimetres to some several tens of centimetres, mainly in urban and high vegetation areas where the occultation of the GNSS system introduces a degradation of the georeferenced trajectory. Along this article a different method point cloud registration is proposed. In addition to the efficiency and speed of execution, the main advantages of the method are related to the fact that the adjustment is continuously made over the trajectory, based on the GPS time. The process is fully automatic and only information recorded in the standard LAS files is used, without the need for any auxiliary information, in particular regarding the trajectory.
Johansen, Antony; Boulton, Christopher; Hertz, Karen; Ellis, Michael; Burgon, Vivienne; Rai, Sunil; Wakeman, Rob
The National Hip Fracture Database (NHFD) is a key clinical governance programme for staff working in trauma wards across England, Wales and Northern Ireland. It uses prospectively collected information about the 65,000 people who present with hip fracture each year, and links these with information about the quality of care and outcome for each individual. The NHFD can, therefore, provide a picture of the care offered to frail older people with this injury - people who, between them, occupy nearly half of inpatient trauma beds. The NHFD uses its website (www.nhfd.co.uk) to feed back live information to each of the countries' 180 trauma units - allowing them to bench mark their performance against national standards, and against that in other hospitals. This helps to develop a consensus over the best care for frail older people in areas where national guidance is not yet available. This article shows how the NHFD is contributing to four key aspects of patient safety and nursing care: the prevention of pressure ulcers and post-operative delirium, the monitoring of falls incidence across hospitals and nutritional assessment of patients with hip fracture. Copyright © 2017 Elsevier Ltd. All rights reserved.
Rath, Barbara; Conrad, Tim; Myles, Puja; Alchikh, Maren; Ma, Xiaolin; Hoppe, Christian; Tief, Franziska; Chen, Xi; Obermeier, Patrick; Kisler, Bron; Schweiger, Brunhilde
Influenza-Like Illness is a leading cause of hospitalization in children. Disease burden due to influenza and other respiratory viral infections is reported on a population level, but clinical scores measuring individual changes in disease severity are urgently needed. Areas covered: We present a composite clinical score allowing individual patient data analyses of disease severity based on systematic literature review and WHO-criteria for uncomplicated and complicated disease. The 22-item ViVI Disease Severity Score showed a normal distribution in a pediatric cohort of 6073 children aged 0-18 years (mean age 3.13; S.D. 3.89; range: 0 to 18.79). Expert commentary: The ViVI Score was correlated with risk of antibiotic use as well as need for hospitalization and intensive care. The ViVI Score was used to track children with influenza, respiratory syncytial virus, human metapneumovirus, human rhinovirus, and adenovirus infections and is fully compliant with regulatory data standards. The ViVI Disease Severity Score mobile application allows physicians to measure disease severity at the point-of care thereby taking clinical trials to the next level.
It is recommended that more recognition be given to the important role of trial counsellors in clinical trials, and that they be given more formal training, support and ... Daar word aanbeveel dat meer erkenning gegee word aan die rol van proefvoorligters in kliniese proewe, dat hulle meer formele opleiding ondergaan, dat ...
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 ...
Angaran, David M.
A look at pharmaceutical care needs in the future is the basis for discussion of the educational needs of clinical pharmacists. Issues discussed include the appropriate degree (bachelor's vs. doctoral), costs of instruction, faculty/student ratios, the pharmacy practice faculty as role models, and computer-assisted instruction. (MSE)
Angus G K McNair
Full Text Available The CONSORT extension for patient reported outcomes (PROs aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the 'take home' message for clinicians to use in practice.The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice.From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a "detailed", "general", or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30% and 6 (16% combined papers reported "detailed" PRO rationale and integrated interpretation of results although only 2 (14% and 1 (7% primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73% and 3 (20% achieving "detailed" rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2.It is recommended that single papers, with detailed PRO rationale and integrated PRO and
McNair, Angus G K; Macefield, Rhiannon C; Blencowe, Natalie S; Brookes, Sara T; Blazeby, Jane M
The CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs) in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the 'take home' message for clinicians to use in practice. The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis) in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice. From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a "detailed", "general", or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30%) and 6 (16%) combined papers reported "detailed" PRO rationale and integrated interpretation of results although only 2 (14%) and 1 (7%) primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73%) and 3 (20%) achieving "detailed" rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2). It is recommended that single papers, with detailed PRO rationale and integrated PRO and clinical data
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.
... the Clinical Setting: Electronic Health Records AGENCY: The National Institute for Occupational Safety... inclusion of work information in the electronic health record (EHR). NIOSH requests input on these issues... Information in Electronic Health Records'' written by the Institute of Medicine (IOM) Committee on Occupation...
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.
Wentz, B; Bell, R K; Hefler, T; Kauer, T; Kreutzmeier, G; Seggewies, C; Seibold, H; Horbach, L
The University of Erlangen-Nürnberg contains a large medical faculty with many hospitals, laboratories, and other departments distributed in the town of Erlangen, and it is necessary to exchange medical data between them. For example the basic patient data which are held on central computers, must be distributed to various stations and departments. In addition medical reports which are prepared on or generated by computers in central departments must be transmitted to various points in the hospitals . When the network, based on ethernet cabling within the hospitals and a glass fiber backbone, has been completed, the Erlangen hospital communication system will support an electronic exchange of medical information. Two separate communication methods are used: data exchange via electronic mail according to the international standard X.400 and remote access to central databases using the software product NET-WORK.
A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM.
Yamamoto, Keiichi; Ota, Keiko; Akiya, Ippei; Shintani, Ayumi
The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) can be used for new drug application studies as well as secondarily for creating a clinical research data warehouse to leverage clinical research study data across studies conducted within the same disease area. However, currently not all clinical research uses Clinical Data Acquisition Standards Harmonization (CDASH) beginning in the set-up phase of the study. Once already initiated, clinical studies that have not utilized CDASH are difficult to map in the SDTM format. In addition, most electronic data capture (EDC) systems are not equipped to export data in SDTM format; therefore, in many cases, statistical software is used to generate SDTM datasets from accumulated clinical data. In order to facilitate efficient secondary use of accumulated clinical research data using SDTM, it is necessary to develop a new tool to enable mapping of information for SDTM, even during or after the clinical research. REDCap is an EDC system developed by Vanderbilt University and is used globally by over 2100 institutions across 108 countries. In this study, we developed a simulated clinical trial to evaluate a tool called REDCap2SDTM that maps information in the Field Annotation of REDCap to SDTM and executes data conversion, including when data must be pivoted to accommodate the SDTM format, dynamically, by parsing the mapping information using R. We confirmed that generating SDTM data and the define.xml file from REDCap using REDCap2SDTM was possible. Conventionally, generation of SDTM data and the define.xml file from EDC systems requires the creation of individual programs for each clinical study. However, our proposed method can be used to generate this data and file dynamically without programming because it only involves entering the mapping information into the Field Annotation, and additional data into specific files. Our proposed method is adaptable not only to new drug
The objective of this study is to investigate the terminology of the femoral artery and recommended alternative terminology that satisfies both anatomy and clinical arenas.The femoral artery (FA) is often defined as the continuation of the external iliac artery. Specifically, when the external iliac artery reaches directly beneath the inguinal ligament, it becomes the FA. Currently, Terminologia Anatomica (TA) records the profunda femoris or deep femoral as a terminal branch. Clinicians often use superficial femoral artery (SFA) rather than FA and profunda or deep FA. SFA is actually very deep and well protected for most of its journey. On observation, the terminology in current use is not intuitive. The objective of this study was to investigate the terminology associated with the anatomical and clinical anatomical interpretations of the FA and its terminal branches and to suggest a more appropriate terminology that addresses the points of view of the macro anatomist, as well as that of the clinician. Literature search was conducted regarding the nomenclature of the FA and its terminal branches. Dissection of 89 embalmed cadavers (49F, 40M, ages 47-89) was conducted to analyze the morphology of the FA and its branches. Perusal of the literature revealed a difference in terminology between anatomical and clinical textbooks/atlases/journals regarding the FA and its terminal branch. Our dissections suggested that the FA may be better defined vis-à-vis its relationship to the anterior and posterior compartments of the thigh. A difference in terminology exists between the anatomical and clinical arenas. A need for a standardized terminology is necessary because clinicians and their publishers have not adopted TA. This study suggests that the current FA be considered the common FA and the continuation of the FA, the SFA be renamed the anterior FA and the current profunda (the deep FA) be renamed the posterior FA, respectively. The proposed terminology mirrors the lower
Saghaeiannejad-Isfahani, Sakineh; Sharifi-Rad, Javad; Raeisi, Ahmadreza; Ehteshami, Asghar; Mirzaeian, Razieh
Pharmacy information system (PIS) is a complex computerized system used for collecting, storing, and managing the medication therapy data in the course of patients' care. The purpose of this study was to evaluate the level of adherence to the standards established by the societies of pharmacists in the PISs employed in the hospitals in Isfahan, Iran. The present study was an applied, descriptive-analytical study conducted on the PISs of 19 teaching, private and social insurance hospitals in Isfahan in 2011. Study population consisted of the PISs available in the hospitals under study. Study sample was the same as the study population. The data collection instrument was a self-developed checklist based on the guidelines of the American Society of Health-System Pharmacists and Pharmaceutical Society of Australia, whose validity was assessed and confirmed by expert professors' views. Having been collected by observation and interview methods, data were analyzed by SPSS 18 software using Mann-Whitney statistical test. The findings of the study revealed that the highest rank in adherence to the standards of societies of pharmacists was obtained by social services hospitals (32.75%), while the private hospitals obtained the lowest rank (23.32%). Based on the findings, in the PISs in the hospitals under study, some standards of the society of pharmacists were ignored. Hence, prior to designing and implementing PIS, a needs analysis is required to increase its users' motivation to identify the system potentialities and to allow the system development in compliance with the world technology advancement.
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.
Full Text Available More than 120 countries use the International Financial Reporting Standards (IFRS and the International Accounting Standards (IAS. The Association Agreement between Ukraine and the EU obliges Ukraine to consider European convergence of accounting and reporting. Since 2012 for some entities the use of IFRS has been compulsory, but for others – voluntary. This trend coincides with the imperative necessity of the consumer cooperation of Ukraine to reform its multilevel informational system as a key component of its effective management and successful implementation of controlling. It is proposed to start reforming with the introduction of IFRS and IAS. Consumer cooperation represents cooperative sector of Ukrainian economy and is included into different international and European cooperative associations. With its historic mission to meet the needs of its members, socio-economic and cultural development of rural areas, in terms of the crisis it faces the serious problem of the systemic reforming under existing conditions through the innovative development and use of experience of economically developed countries, especially the EU.
Guo, Jinqiu; Takada, Akira; Tanaka, Koji; Sato, Junzo; Suzuki, Muneou; Takahashi, Kiwamu; Daimon, Hiroyuki; Suzuki, Toshiaki; Nakashima, Yusei; Araki, Kenji; Yoshihara, Hiroyuki
With the evolving and diverse electronic medical record (EMR) systems, there appears to be an ever greater need to link EMR systems and patient accounting systems with a standardized data exchange format. To this end, the CLinical Accounting InforMation (CLAIM) data exchange standard was developed. CLAIM is subordinate to the Medical Markup Language (MML) standard, which allows the exchange of medical data among different medical institutions. CLAIM uses eXtensible Markup Language (XML) as a meta-language. The current version, 2.1, inherited the basic structure of MML 2.x and contains two modules including information related to registration, appointment, procedure and charging. CLAIM 2.1 was implemented successfully in Japan in 2001. Consequently, it was confirmed that CLAIM could be used as an effective data exchange format between EMR systems and patient accounting systems.
Meacock, Rachel; Sutton, Matt
IntroductionPatients admitted to hospital in an emergency at weekends have been found to experience higher mortality rates than those admitted during the week. The NHS in England has introduced four priority clinical standards for emergency hospital care with the objective of reducing the deaths associated with this ‘weekend effect’. This study aimed to determine whether adoption of these clinical standards is associated with the extent to which weekend mortality is elevated. MethodsWe utilis...
Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio
This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical
Legaz-García, María del Carmen; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás; Chute, Christopher G; Tao, Cui
The semantic interoperability of electronic healthcare records (EHRs) systems is a major challenge in the medical informatics area. International initiatives pursue the use of semantically interoperable clinical models, and ontologies have frequently been used in semantic interoperability efforts. The objective of this paper is to propose a generic, ontology-based, flexible approach for supporting the automatic transformation of clinical models, which is illustrated for the transformation of Clinical Element Models (CEMs) into openEHR archetypes. Our transformation method exploits the fact that the information models of the most relevant EHR specifications are available in the Web Ontology Language (OWL). The transformation approach is based on defining mappings between those ontological structures. We propose a way in which CEM entities can be transformed into openEHR by using transformation templates and OWL as common representation formalism. The transformation architecture exploits the reasoning and inferencing capabilities of OWL technologies. We have devised a generic, flexible approach for the transformation of clinical models, implemented for the unidirectional transformation from CEM to openEHR, a series of reusable transformation templates, a proof-of-concept implementation, and a set of openEHR archetypes that validate the methodological approach. We have been able to transform CEM into archetypes in an automatic, flexible, reusable transformation approach that could be extended to other clinical model specifications. We exploit the potential of OWL technologies for supporting the transformation process. We believe that our approach could be useful for international efforts in the area of semantic interoperability of EHR systems. © 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.
Kun, Larry E.
Objectives: To review the clinical characteristics of childhood brain tumors, including neurologic signs, neuroimaging and neuropathology. To critically assess indications for therapy relevant to presenting characteristics, age, and disease status. To discuss current management strategies including neurosurgery, radiation therapy, and chemotherapy. To analyze current clinical trials and future directions of clinical research. Brain tumors account for 20% of neoplastic diseases in children. The most common tumors include astrocytoma and malignant gliomas, medulloblastoma and supratentorial PNET's, ependymoma, craniopharyngioma, and intracranial germ cell tumors. The clinical characteristics and disease extent largely determine the relative merits of available 'standard' and investigational therapeutic approaches. Treatment outcome, including disease control and functional integrity, is dependent upon tumor type and site, age at presentation, and disease extent. An understanding of the clinical, neuroimaging, and histologic characteristics as they relate to decisions regarding therapy is critical to the radiation oncologist. Appropriate radiation therapy is central to curative therapy for a majority of pediatric brain tumor presentations. Technical advances in neurosurgery provide greater safety for 'gross total resection' in a majority of hemispheric astrocytomas and medulloblastomas. The relative roles of radiation therapy and chemotherapy for centrally located astrocytomas (e.g., diencephalic, optic pathway) need to be analyzed in the context of initial and overall disease control, neurotoxicities, and potential modifications in the risk:benefit ratio apparent in the introduction of 3-dimensional radiation techniques. Modifications in radiation delivery are important components of current investigations in medulloblastoma; the rationale for contemporary cooperative group trials will be presented as well as the background data re surgical, radiotherapeutic, and
Powell, M B F; Ahlers-Schmidt, C R; Engel, M; Bloom, B T
To define the impact of care standardization on caffeine and cardiorespiratory monitoring at neonatal intensive care unit (NICU) discharge. Electronic records were abstracted for infants aged 24-36 weeks gestation with birth weights appropriate for gestational age. Infants who died, transferred prior to discharge, had major pulmonary anomalies, required a home monitor for mechanical ventilation or had a family history of sudden infant death syndrome were excluded. Data and records were used to indicate when the new definition of clinically significant cardiopulmonary events (CSCPEs) and concurrent education was implemented. Preimplementation and postimplementation cohorts were compared. Incidence fell from 74% diagnosed with apnea of prematurity at baseline to 49% diagnosed with CSCPE postimplementation (Pdefinitions and treatments reduced the use of caffeine and cardiorespiratory monitors upon NICU dismissal.
Mussini, C; Antinori, A; Bhagani, S
OBJECTIVES: The objective of the 1st European AIDS Clinical Society meeting on Standard of Care in Europe was to raise awareness of the European scenario and come to an agreement on actions that could be taken in the future. METHODS: Data-driven presentations were given on specific topics followed...... by interactive panel discussions. RESULTS: In Eastern European countries, the epidemic is largely driven by injecting drug use, in contrast with Western Europe where the infection mainly occurs through heterosexual contact. A high proportion of people living with HIV remain unaware of their infection...... diagnosed multi-drug-resistant cases. Hepatitis C is widespread in selected geographical areas and risk groups. CONCLUSIONS: The key conclusion from the meeting was that a high-priority group of actions could be identified, including: increasing HIV awareness and testing, improving training for health care...
The article presents ISO standards for information and documentation and their use in the only Slovenian scientific forestry journal, Zbornik gozdarstva in lesarstva = Research reports: forest and wood science & technology, ISSN 0351-3114.
Zhai, Haijun; Lingren, Todd; Deleger, Louise; Li, Qi; Kaiser, Megan; Stoutenborough, Laura; Solti, Imre
A high-quality gold standard is vital for supervised, machine learning-based, clinical natural language processing (NLP) systems. In clinical NLP projects, expert annotators traditionally create the gold standard. However, traditional annotation is expensive and time-consuming. To reduce the cost of annotation, general NLP projects have turned to crowdsourcing based on Web 2.0 technology, which involves submitting smaller subtasks to a coordinated marketplace of workers on the Internet. Many studies have been conducted in the area of crowdsourcing, but only a few have focused on tasks in the general NLP field and only a handful in the biomedical domain, usually based upon very small pilot sample sizes. In addition, the quality of the crowdsourced biomedical NLP corpora were never exceptional when compared to traditionally-developed gold standards. The previously reported results on medical named entity annotation task showed a 0.68 F-measure based agreement between crowdsourced and traditionally-developed corpora. Building upon previous work from the general crowdsourcing research, this study investigated the usability of crowdsourcing in the clinical NLP domain with special emphasis on achieving high agreement between crowdsourced and traditionally-developed corpora. To build the gold standard for evaluating the crowdsourcing workers' performance, 1042 clinical trial announcements (CTAs) from the ClinicalTrials.gov website were randomly selected and double annotated for medication names, medication types, and linked attributes. For the experiments, we used CrowdFlower, an Amazon Mechanical Turk-based crowdsourcing platform. We calculated sensitivity, precision, and F-measure to evaluate the quality of the crowd's work and tested the statistical significance (Pcrowdsourced and traditionally-developed annotations. The agreement between the crowd's annotations and the traditionally-generated corpora was high for: (1) annotations (0.87, F-measure for medication names
Meulendijks, A.; Batenburg, R.; Wetering, R. van de
In the last decade, many information system (IS) implementations took place in the healthcare organisations. Mainstream reasons for this evolvement are the increase of quality and safety of care, and reducing costs. As in many other sectors IS implementations in healthcare are complex, and
Revilla-López, Concha; Calderón-Larrañaga, Amaia; Enríquez-Martín, Natalia; Prados-Torres, Alexandra
To measure the diagnostic agreement between Primary Care (PC) and hospital information systems, in order to assess the usefulness of health care records for research purposes. Cross-sectional retrospective study integrating PC and hospital diagnostic information for the Aragon population admitted to hospital in 2010. 75.176 patients were analysed. Similarities, differences and the kappa index were calculated for each of the diagnoses recorded in both information systems. The studied diseases included COPD, diabetes, hypertension, cerebrovascular disease, ischaemic heart disease, asthma, epilepsy, and heart failure. Diagnostic concordance was higher in men and between 45 and 64 years. Diabetes was the condition showing the highest concordance (kappa index: 0.75), while asthma had the lowest values (kappa index: 0.34). The low concordance between the diagnostic information recorded in PC and in the hospital setting calls for urgent measures to ensure that healthcare professionals have a comprehensive picture of patient's health problems. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.
Elger, Bernice S
The article discusses from an ethical point of view the question whether a physician should tell the patient the whole truth about a poor prognosis. From a legal viewpoint, the therapeutic privilege gives physicians in most countries the right to limit information, if they are concerned that this information will severely harm the patient. An overview about empirical studies, especially surveys of physicians and patients, shows that most patients always wish to know their prognosis, while physicians would less often tell the whole truth. Physicians explain their attitudes by referring to the ethical principles of nonmaleficience and beneficience. These principles are apparently in conflict with the principles of veracity and respect of patient autonomy. However, it can be shown that this conflict does not persist when empirical data about consequences of truthful information are considered: telling the truth seems not to have negative, but rather positive consequences on the overall well-being of the patient. After having summarized the empirical studies that have examined the consequences of truthful information about severe and incurable diseases, the article argues for always telling patients the truth if they want to know it. Many conflicts in medical ethics are between prima facie principles. In cases where the principles of beneficience and nonmaleficience are used in the argumentation, some of the conflicts can be eliminated when the ethical judgment is made on a thorough empirical basis, as shown by the example of truth-telling about prognosis.
Cohn, Elizabeth Gross; Jia, Haomiao; Smith, Winifred Chapman; Erwin, Katherine; Larson, Elaine L
To develop and assess the reliability and validity of an observational instrument, the Process and Quality of Informed Consent (P-QIC). A pilot study of the psychometrics of a tool designed to measure the quality and process of the informed consent encounter in clinical research. The study used professionally filmed, simulated consent encounters designed to vary in process and quality. A major urban teaching hospital in the northeastern region of the United States. 63 students enrolled in health-related programs participated in psychometric testing, 16 students participated in test-retest reliability, and 5 investigator-participant dyads were observed for the actual consent encounters. For reliability and validity testing, students watched and rated videotaped simulations of four consent encounters intentionally varied in process and content and rated them with the proposed instrument. Test-retest reliability was established by raters watching the videotaped simulations twice. Inter-rater reliability was demonstrated by two simultaneous but independent raters observing an actual consent encounter. The essential elements of information and communication for informed consent. The initial testing of the P-QIC demonstrated reliable and valid psychometric properties in both the simulated standardized consent encounters and actual consent encounters in the hospital setting. The P-QIC is an easy-to-use observational tool that provides a quick assessment of the areas of strength and areas that need improvement in a consent encounter. It can be used in the initial trainings of new investigators or consent administrators and in ongoing programs of improvement for informed consent. The development of a validated observational instrument will allow investigators to assess the consent process more accurately and evaluate strategies designed to improve it.
Canova, D; Roatta, S; Bosone, D; Micieli, G
The attractive possibility of near infrared spectroscopy (NIRS) to noninvasively assess cerebral blood volume and oxygenation is challenged by the possible interference from extracranial tissues. However, to what extent this may affect cerebral NIRS monitoring during standard clinical tests is ignored. To address this issue, 29 healthy subjects underwent a randomized sequence of three maneuvers that differently affect intra- and extracranial circulation: Valsalva maneuver (VM), hyperventilation (HV), and head-up tilt (HUT). Putative intracranial ("i") and extracranial ("e") NIRS signals were collected from the forehead and from the cheek, respectively, and acquired together with cutaneous plethysmography at the forehead (PPG), cerebral blood velocity from the middle cerebral artery, and arterial blood pressure. Extracranial contribution to cerebral NIRS monitoring was investigated by comparing Beer-Lambert (BL) and spatially resolved spectroscopy (SRS) blood volume indicators [the total hemoglobin concentration (tHb) and the total hemoglobin index, (THI)] and by correlating their changes with changes in extracranial circulation. While THIe and tHbe generally provided concordant indications, tHbi and THIi exhibited opposite-sign changes in a high percentage of cases (VM: 46%; HV: 31%; HUT: 40%). Moreover, tHbi was correlated with THIi only during HV (P < 0.05), not during VM and HUT, while it correlated with PPG in all three maneuvers (P < 0.01). These results evidence that extracranial circulation may markedly affect BL parameters in a high percentage of cases, even during standard clinical tests. Surface plethysmography at the forehead is suggested as complementary monitoring helpful in the interpretation of cerebral NIRS parameters.
Bruland, Philipp; Doods, Justin; Storck, Michael; Dugas, Martin
Data dictionaries provide structural meta-information about data definitions in health information technology (HIT) systems. In this regard, reusing healthcare data for secondary purposes offers several advantages (e.g. reduce documentation times or increased data quality). Prerequisites for data reuse are its quality, availability and identical meaning of data. In diverse projects, research data warehouses serve as core components between heterogeneous clinical databases and various research applications. Given the complexity (high number of data elements) and dynamics (regular updates) of electronic health record (EHR) data structures, we propose a clinical metadata warehouse (CMDW) based on a metadata registry standard. Metadata of two large hospitals were automatically inserted into two CMDWs containing 16,230 forms and 310,519 data elements. Automatic updates of metadata are possible as well as semantic annotations. A CMDW allows metadata discovery, data quality assessment and similarity analyses. Common data models for distributed research networks can be established based on similarity analyses.
Brothers, John F; Ung, Matthew; Escalante-Chong, Renan; Ross, Jermaine; Zhang, Jenny; Cha, Yoonjeong; Lysaght, Andrew; Funt, Jason; Kusko, Rebecca
The tremendous expansion of data analytics and public and private big datasets presents an important opportunity for pre-clinical drug discovery and development. In the field of life sciences, the growth of genetic, genomic, transcriptomic and proteomic data is partly driven by a rapid decline in experimental costs as biotechnology improves throughput, scalability, and speed. Yet far too many researchers tend to underestimate the challenges and consequences involving data integrity and quality standards. Given the effect of data integrity on scientific interpretation, these issues have significant implications during preclinical drug development. We describe standardized approaches for maximizing the utility of publicly available or privately generated biological data and address some of the common pitfalls. We also discuss the increasing interest to integrate and interpret cross-platform data. Principles outlined here should serve as a useful broad guide for existing analytical practices and pipelines and as a tool for developing additional insights into therapeutics using big data. Copyright © 2018 Elsevier Inc. All rights reserved.
Roberts, William L; Boulet, John; Sandella, Jeanne
When the safety of the public is at stake, it is particularly relevant for licensing and credentialing exam agencies to use defensible standard setting methods to categorize candidates into competence categories (e.g., pass/fail). The aim of this study was to gather evidence to support change to the Comprehensive Osteopathic Medical Licensing-USA Level 2-Performance Evaluation standard setting design and administrative process. Twenty-two video recordings of candidates assessed for clinical competence were randomly selected from the 2014-2015 Humanistic domain test score distribution ranging from the highest to lowest quintile of performance. Nineteen panelists convened at the same site to receive training and practice prior to generating judgments of qualified or not qualified performance to each of the twenty videos. At the end of training, one panel remained onsite to complete their judgments and the second panel was released and given 1 week to observe the same twenty videos and complete their judgments offsite. The two one-sided test procedure established equivalence between panel group means at the 0.05 confidence level, controlling for rater errors within each panel group. From a practical cost-effective and administrative resource perspective, results from this study suggest it is possible to diverge from typical panel groups, who are sequestered the entire time onsite, to larger numbers of panelists who can make their judgments offsite with little impact on judged samples of qualified performance. Standard setting designs having panelists train together and then allowing those to provide judgments yields equivalent ratings and, ultimately, similar cut scores.
Needleman, Mark H.
Reviews developments related to standards in electronic and networked information. Discusses traditional library and Internet communities, and notes the importance of having a supporting infrastructure in place. Topics include: Z39.50; Z39.56 Serial Item/Contribution Identifier (SICI); Interlibrary Loan (ILL) Protocol; character set standards;…
Harvey, Matthew J; Mason, Nicholas J; McLean, Andrew; Murray-Rust, Peter; Rzepa, Henry S; Stewart, James J P
The desirable curation of 158,122 molecular geometries derived from the NCI set of reference molecules together with associated properties computed using the MOPAC semi-empirical quantum mechanical method and originally deposited in 2005 into the Cambridge DSpace repository as a data collection is reported. The procedures involved in the curation included annotation of the original data using new MOPAC methods, updating the syntax of the CML documents used to express the data to ensure schema conformance and adding new metadata describing the entries together with a XML schema transformation to map the metadata schema to that used by the DataCite organisation. We have adopted a granularity model in which a DataCite persistent identifier (DOI) is created for each individual molecule to enable data discovery and data metrics at this level using DataCite tools. We recommend that the future research data management (RDM) of the scientific and chemical data components associated with journal articles (the "supporting information") should be conducted in a manner that facilitates automatic periodic curation. Graphical abstractStandards and metadata-based curation of a decade-old digital repository dataset of molecular information.
Eva Maria Tscherner
Full Text Available ENGLISH: Current European consumer law mainly acts on the assumption that people behave in line with the ‘rational man’ (homo oeconomicus, who has stable preferences and can absorb all available information and process as well as integrate it into her consumer decisions. This assumption has been challenged by findings of behavioral sciences such as behavioral economics, psychology and neurosciences. This article examines if and how findings from behavioral research are in a position to advance European consumer contract law (mandatory law in general as well as information duties, standard terms and rights to withdraw in specific. DEUTSCH: Das Europäische Verbraucherschutzrecht stützt sich in weiten Teilen auf das ökonomische Menschenbild des homo oeconomicus. Dieser verfügt über stabile Präferenzen und kann unbegrenzt Informationen aufnehmen sowie diese in seinen Entscheidungsprozess integrieren. Dieses Menschenbild wurde durch Forschungsergebnisse in Verhaltensökonomik, Psychologie und Gehirnforschung in Frage gestellt. De r Aufsatz geht der Frage nach, inwieweit das Verbrauchervertragsrecht (in Form von zwingendem Recht, vor - vertraglichen Informationspflichten, Fairnesskontrolle Allgemeiner Geschäftsbedingungen und Widerrufsrechten von Erkenntnissen dieser sog Verhaltensforschung profitieren kann.
Al-Issa, Reham E.
The purpose of this qualitative study was to explore the experiences of undergraduate college students attending a public and a private university in the State of Kuwait to understand how they develop their understanding and valuing of information literacy and information literacy standards. Data from student and faculty interviews and student…
Villalba-Mora, Elena; Casas, Isabel; Lupiañez-Villanueva, Francisco
OBJECTIVES: We investigated the level of adoption of Health Information Technologies (HIT) services, and the factors that influence this, amongst specialised and primary care physicians; in Andalusia, Spain. METHODS: We analysed the physicians' responses to an online survey. First, we performed...... a statistical descriptive analysis of the data; thereafter, a principal component analysis; and finally an order logit model to explain the effect of the use in the adoption and to analyse which are the existing barriers. RESULTS: The principal component analysis revealed three main uses of Health Information...... 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...
In 2011, nearly 13 million nonsurgical cosmetic procedures were performed, representing a 6% increase from the previous year. Patients often present with unrealistic treatment expectations based on beauty industry standards and misinformation. In addition, due to the lack of competency standardization in this area, providers frequently deliver…
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
Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio
The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective. Copyright Â© 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Crasto, Jared A; Sayari, Arash J; Gray, Robert R-L; Askari, Morad
Assessment of joint range of motion (ROM) is an accepted evaluation of disability as well as an indicator of recovery from musculoskeletal injuries. Many goniometric techniques have been described to measure ROM, with variable validity due to inter-rater reliability. In this report, we assessed the validity of photograph-based goniometry in measurement of ROM and its inter-rater reliability and compared it to two other commonly used techniques. We examined three methods for measuring ROM in the upper extremity: manual goniometry (MG), visual estimations (VE), and photograph-based goniometry (PBG). Eight motions of the upper extremity were measured in 69 participants at an academic medical center. We found visual estimations and photograph-based goniometry to be clinically valid when tested against manual goniometry (r avg. 0.58, range 0.28 to 0.87). Photograph-based measurements afforded a satisfactory degree of inter-rater reliability (ICC avg. 0.77, range 0.28 to 0.96). Our study supports photograph-based goniometry as the new standard goniometric technique, as it has been clinically validated, is performed with greater consistency and better inter-rater reliability when compared with manual goniometry. It also allows for better documentation of measurements and potential incorporation into medical records in direct contrast to visual estimation.
Saleeb, Susan F; McLaughlin, Sarah R; Graham, Dionne A; Friedman, Kevin G; Fulton, David R
Using a Standardized Clinical Assessment and Management Plan (SCAMP) for pediatric patients presenting to clinic with chest pain, we evaluated the cost impact associated with implementation of the care algorithm. Prior to introduction of the SCAMP, we analyzed charges for 406 patients with chest pain, seen in 2009, and predicted 21% reduction of overall charges had the SCAMP methodology been used. The SCAMP recommended an echocardiogram for history, examination, or ECG findings suggestive of a cardiac etiology for chest pain. Resource utilization was reviewed for 1517 patients (7-21 years) enrolled in the SCAMP from July 2010 to April 2014. Compared to the 2009 historic cohort, patients evaluated by the SCAMP had higher rates of exertional chest pain (45% vs 37%) and positive family history (5% vs 1%). The SCAMP cohort had fewer abnormal physical examination findings (1% vs 6%) and abnormal electrocardiograms (3% vs 5%). Echocardiogram use increased in the SCAMP cohort compared to the 2009 historic cohort (45% vs 41%), whereas all other ancillary testing was reduced: exercise stress testing (4% SCAMP vs 28% historic), Holter (4% vs 7%), event monitors (3% vs 10%), and MRI (1% vs 2%). Total charges were reduced by 22% ($822 625) by use of the Chest Pain SCAMP, despite a higher percentage of patients for whom echocardiogram was recommended compared to the historic cohort. The Chest Pain SCAMP effectively streamlines cardiac testing and reduces resource utilization. Further reductions can be made by algorithm refinement regarding echocardiograms for exertional symptoms. © 2017 Wiley Periodicals, Inc.
Bo Young Yoon
Full Text Available Purpose: The quality of problem representation is critical for developing students’ problem-solving abilities in problem-based learning (PBL. This study investigates preclinical students’ experience with standardized patients (SPs as a problem representation method compared to using video cases in PBL. Methods: A cohort of 99 second-year preclinical students from Inje University College of Medicine (IUCM responded to a Likert scale questionnaire on their learning experiences after they had experienced both video cases and SPs in PBL. The questionnaire consisted of 14 items with eight subcategories: problem identification, hypothesis generation, motivation, collaborative learning, reflective thinking, authenticity, patient-doctor communication, and attitude toward patients. Results: The results reveal that using SPs led to the preclinical students having significantly positive experiences in boosting patient-doctor communication skills; the perceived authenticity of their clinical situations; development of proper attitudes toward patients; and motivation, reflective thinking, and collaborative learning when compared to using video cases. The SPs also provided more challenges than the video cases during problem identification and hypotheses generation. Conclusion: SPs are more effective than video cases in delivering higher levels of authenticity in clinical problems for PBL. The interaction with SPs engages preclinical students in deeper thinking and discussion; growth of communication skills; development of proper attitudes toward patients; and motivation. Considering the higher cost of SPs compared with video cases, SPs could be used most advantageously during the preclinical period in the IUCM curriculum.
Yoon, Bo Young; Choi, Ikseon; Choi, Seokjin; Kim, Tae-Hee; Roh, Hyerin; Rhee, Byoung Doo; Lee, Jong-Tae
The quality of problem representation is critical for developing students' problem-solving abilities in problem-based learning (PBL). This study investigates preclinical students' experience with standardized patients (SPs) as a problem representation method compared to using video cases in PBL. A cohort of 99 second-year preclinical students from Inje University College of Medicine (IUCM) responded to a Likert scale questionnaire on their learning experiences after they had experienced both video cases and SPs in PBL. The questionnaire consisted of 14 items with eight subcategories: problem identification, hypothesis generation, motivation, collaborative learning, reflective thinking, authenticity, patient-doctor communication, and attitude toward patients. The results reveal that using SPs led to the preclinical students having significantly positive experiences in boosting patient-doctor communication skills; the perceived authenticity of their clinical situations; development of proper attitudes toward patients; and motivation, reflective thinking, and collaborative learning when compared to using video cases. The SPs also provided more challenges than the video cases during problem identification and hypotheses generation. SPs are more effective than video cases in delivering higher levels of authenticity in clinical problems for PBL. The interaction with SPs engages preclinical students in deeper thinking and discussion; growth of communication skills; development of proper attitudes toward patients; and motivation. Considering the higher cost of SPs compared with video cases, SPs could be used most advantageously during the preclinical period in the IUCM curriculum.
Shafiq, Nusrat; Malhotra, Samir
Comprehension of informed consent form has not achieved the attention it deserves. We made a 24-item questionnaire to assess clinical research participants' comprehension of informed consent form (Contemp Clin Trials 2009;30:427-30). Due to repeated requests by clinical researchers in our country and abroad, we are publishing the questionnaire in this article. Copyright © 2010 Elsevier Inc. All rights reserved.
Karimi, Zohreh; Ashrafi-Rizi, Hasan; Papi, Ahmad; Shahrzadi, Leila; Hassanzadeh, Akbar
Information literacy is the basis for lifelong learning. Information literacy skills, especially for student in an environment that is full of information from multiple technologies are being developed is equally important. Information literacy is a set of cognitive and practical skills and like any other science, proper training is needed, and standard-based education is definitely better and evaluation would be easier. This study aimed to determine the impact of information literacy training course on information literacy skills of Isfahan University of Medical Sciences students based on ACRL standard in 2012. The study method is semi-experience with two group design (with pre-test and post-test) and applied. The data collection toll was a questionnaire assessing student's information literacy that developed by Davarpanah and Siamak and validity was confirmed by professional librarians and reliability as measured by Cronbach's alpha, was 0.83. The sample consisted of 50 undergraduate students from Isfahan University of Medical Sciences that by random sampling method was perch in both case and control groups. Before and after the training (once a week), a questionnaire was distributed between the two groups. This training was held in a classroom equipped with computers with internet access and in addition to training using brochures and librarian presentation, interactive methods such as discussion and exercises were used. The data were analyzed using SPSS version 20 software and two level of descriptive (mean and SD) and inferential statistics (t-test and t-paired). The results showed that the students' information literacy scores before the training was lower than average, so that in the control group was 32.96 and in the case group was 33.24; while information literacy scores in the case group significantly increased after the training (46.68). Also, the effect of education, respectively had a greater impact on the ability to access information (the second
Full Text Available Introduction:Although informal coercion is frequently applied in psychiatry its use is discussed controversially. This systematic review aimed to summarize literature on attitudes towards informal coercion, its prevalence and clinical effects.Methods:A systematic search of Pubmed, Embase, PsycINF and Google Scholar was conducted. Publications were included if they reported original data describing patients’ and clinicians’ attitudes towards and prevalence rates or clinical effects of informal coercion.Results:21 publications out of a total of 162 articles met the inclusion criteria. Most publications focused on leverage and inducements rather than persuasion and threat. Prevalence rates of informal coercion were 29 to 59%, comparable on different study sites and in different settings. The majority of mental health professionals as well as one to two thirds of the psychiatric patients had positive attitudes, even if there was personal experience of informal coercion. We found no study evaluating the clinical effect of informal coercion in an experimental study design.Discussion:Cultural and ethical aspects are associated with the attitudes and prevalence rates. The clinical effect of informal coercion remains unclear and further studies are needed to evaluate these interventions and the effect on therapeutic relationship and clinical outcome. It can be hypothesized that informal coercion may lead to better adherence and clinical outcome but also to strains in the therapeutic relationship. It is recommendable to establish structured education about informal coercion and sensitize mental health professionals for its potential for adverse effects in clinical routine practice.
Sarris, Jerome; Mischoulon, David; Schweitzer, Isaac
Studies using augmentation of pharmacotherapies with nutraceuticals in bipolar disorder (BD) have been conducted and preliminary evidence in many cases appears positive. To date, however, no specialized systematic review of this area has been conducted. We present the first systematic review of clinical trials using nutrient-based nutraceuticals in combination with standard pharmacotherapies to treat BD. A subsequent aim of this report was to discuss posited underlying mechanisms of action. PubMed, CINAHL, Web of Science, and Cochrane Library databases, and grey literature were searched during mid-2010 for human clinical trials in English using nutraceuticals such as omega-3, N-acetyl cysteine (NAC), inositol, and vitamins and minerals, in combination with pharmacotherapies to treat bipolar mania and bipolar depression. A review of the results including an effect size analysis (Cohen's d) was subsequently conducted. In treating bipolar depression, positive evidence with large effect sizes were found for NAC (d=1.04) and a chelated mineral and vitamin formula (d=1.70). On the outcome of bipolar mania, several nutraceuticals reduced mania with strong clinical effects: a chelated mineral formula (d=0.83), L-tryptophan (d=1.47), magnesium (d=1.44), folic acid (d=0.40), and branched-chain amino acids (d=1.60). Mixed, but mainly positive, evidence was found for omega-3 for bipolar depression, while no evidentiary support was found for use in mania. No significant effect on BD outcome scales was found for inositol (possibly due to small samples). BD treatment outcomes may potentially be improved by additional use of certain nutraceuticals with conventional pharmacotherapies. However, caution should be extended in interpreting the large effects of several isolated studies, as they have not yet been replicated in larger trials. © 2011 John Wiley and Sons A/S.
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.
2013 updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy.
Neuss, Michael N; Polovich, Martha; McNiff, Kristen; Esper, Peg; Gilmore, Terry R; LeFebvre, Kristine B; Schulmeister, Lisa; Jacobson, Joseph O
In 2009, ASCO and the Oncology Nursing Society (ONS) published standards for the safe use of parenteral chemotherapy in the outpatient setting, including issues of practitioner orders, preparation, and administration of medication. In 2011, these were updated to include inpatient facilities. In December 2011, a multistakeholder workgroup met to address the issues associated with orally administered antineoplastics, under the leadership of ASCO and ONS. The workgroup participants developed recommended standards, which were presented for public comment. Public comments informed final edits, and the final standards were reviewed and approved by the ASCO and ONS Boards of Directors. Significant newly identified recommendations include those associated with drug prescription and the necessity of ascertaining that prescriptions are filled. In addition, the importance of patient and family education regarding administration schedules, exception procedures, disposal of unused oral medication, and aspects of continuity of care across settings were identified. This article presents the newly developed standards.
Han, Kihwan; Kwon, Hyuk Joon; Choi, Tae Hyun; Kim, Jun Hyung; Son, Daegu
The aim of this study was to standardize clinical photogrammetric techniques, and to compare anthropometry with photogrammetry. To standardize clinical photography, we have developed a photographic cephalostat and chair. We investigated the repeatability of the standardized clinical photogrammetric technique. Then, with 40 landmarks, a total of 96 anthropometric measurement items was obtained from 100 Koreans. Ninety six photogrammetric measurements from the same subjects were also obtained from standardized clinical photographs using Adobe Photoshop version 7.0 (Adobe Systems Corporation, San Jose, CA, USA). The photogrammetric and anthropometric measurement data (mm, degree) were then compared. A coefficient was obtained by dividing the anthropometric measurements by the photogrammetric measurements. The repeatability of the standardized photography was statistically significantly high (p=0.463). Among the 96 measurement items, 44 items were reliable; for these items the photogrammetric measurements were not different to the anthropometric measurements. The remaining 52 items must be classified as unreliable. By developing a photographic cephalostat and chair, we have standardized clinical photogrammetric techniques. The reliable set of measurement items can be used as anthropometric measurements. For unreliable measurement items, applying a suitable coefficient to the photogrammetric measurement allows the anthropometric measurement to be obtained indirectly.
Roh, HyeRin; Park, Kyung Hye; Park, Song Yi
Standardized patients (SPs) tend to rate medical students' communication skills subjectively and comprehensively, in contrast to such objective skill set defined in the clinical performance examination (CPX). Meanwhile, medical school instructors have a different approach in their evaluation of students' communication skills. We aim to analyze medical students' verbal communication skills using objective methods, and to determine the contributing factors of a patient-physician interaction (PPI) score. Students with high- and low-ranking scores for PPI in CPX were selected. The Roter interaction analysis system was used to compare verbal communication behaviors of the students and SPs. Patient-centeredness scores (PCSs), physician's verbal dominance, and number of utterances were compared between the two groups. PCSs and physician's verbal dominance had no difference between the groups. The number of utterances during the limited time of 5 minutes of CPX was higher for the high-ranking students. They tended to employ more paraphrase/check for understanding, and closed questions for psychosocial state and open questions for medical condition. The SPs interviewed by high-ranking students gave more medical information and requested for more services. In the case of the routine checkup, smooth conversations with more frequent utterances were detected in the high-ranking students. More medical information exchange and requests for services by SPs were higher for the high-ranking students. Medical communication instructors should keep in mind that our results could be indicators of a high PPI score.
Oncology nurses have used chemotherapy standards to develop educational materials and guidelines for standardization and safety and anticipate future opportunities to partner in translating evidence into practice.
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.
Full Text Available Abstract Background The presence of counterfeits and sub-standards in African medicines market is a dramatic problem that causes many deaths each year. The increase of the phenomenon of pharmaceutical counterfeiting is due to the rise of the illegal market and to the impossibility to purchase branded high cost medicines. Methods In this paper the results of a quality control on antimalarial tablet samples purchased in the informal market in Congo, Burundi and Angola are reported. The quality control consisted in the assay of active substance by means of validated liquid chromatographic methods, uniformity of mass determination, disintegration and dissolution tests. Moreover, a general evaluation on label and packaging characteristics was performed. Results The results obtained on thirty antimalarial tablet samples containing chloroquine, quinine, mefloquine, sulphadoxine and pyrimethamine showed the presence of different kinds of problems: a general problem concerning the packaging (loose tablets, packaging without Producer name, Producer Country and sometimes without expiry date; low content of active substance (in one sample; different, non-declared, active substance (in one sample; sub-standard technological properties and very low dissolution profiles (in about 50% of samples. This last property could affect the bioavailability and bioequivalence in comparison with branded products and could be related to the use of different excipients in formulation or bad storage conditions. Conclusion This paper evidences that the most common quality problem in the analysed samples appears to be the low dissolution profile. Here it is remarked that the presence of the right active substance in the right quantity is not a sufficient condition for a good quality drug. Dissolution test is not less important in a quality control and often evidences in vitro possible differences in therapeutic efficacy among drugs with the same active content. Dissolution
Vandenbroucke, D.; Van Orshoven, J.; Vancauwenberghe, G.
Over the last decennia, the use of Geographic Information (GI) has gained importance, in public as well as in private sector. But even if many spatial data and related information exist, data sets are scattered over many organizations and departments. In practice it remains difficult to find the spatial data sets needed, and to access, obtain and prepare them for using in applications. Therefore Spatial Data Infrastructures (SDI) haven been developed to enhance the access, the use and sharing of GI. SDIs consist of a set of technological and non-technological components to reach this goal. Since the nineties many SDI initiatives saw light. Ultimately, all these initiatives aim to enhance the flow of spatial data between organizations (users as well as producers) involved in intra- and inter-organizational and even cross-country business processes. However, the flow of information and its re-use in different business processes requires technical and semantic interoperability: the first should guarantee that system components can interoperate and use the data, while the second should guarantee that data content is understood by all users in the same way. GI-standards within the SDI are necessary to make this happen. However, it is not known if this is realized in practice. Therefore the objective of the research is to develop a quantitative framework to assess the impact of GI-standards on the performance of business processes. For that purpose, indicators are defined and tested in several cases throughout Europe. The proposed research will build upon previous work carried out in the SPATIALIST project. It analyzed the impact of different technological and non-technological factors on the SDI-performance of business processes (Dessers et al., 2011). The current research aims to apply quantitative performance measurement techniques - which are frequently used to measure performance of production processes (Anupindi et al., 2005). Key to reach the research objectives
Trigo, Jesús Daniel; Martínez, Ignacio; Alesanco, Alvaro; Kollmann, Alexander; Escayola, Javier; Hayn, Dieter; Schreier, Günter; García, José
This paper investigates the application of the enterprise information system (EIS) paradigm to standardized cardiovascular condition monitoring. There are many specifications in cardiology, particularly in the ECG standardization arena. The existence of ECG formats, however, does not guarantee the implementation of homogeneous, standardized solutions for ECG management. In fact, hospital management services need to cope with various ECG formats and, moreover, several different visualization applications. This heterogeneity hampers the normalization of integrated, standardized healthcare information systems, hence the need for finding an appropriate combination of ECG formats and a suitable EIS-based software architecture that enables standardized exchange and homogeneous management of ECG formats. Determining such a combination is one objective of this paper. The second aim is to design and develop the integrated healthcare information system that satisfies the requirements posed by the previous determination. The ECG formats selected include ISO/IEEE11073, Standard Communications Protocol for Computer-Assisted Electrocardiography, and an ECG ontology. The EIS-enabling techniques and technologies selected include web services, simple object access protocol, extensible markup language, or business process execution language. Such a selection ensures the standardized exchange of ECGs within, or across, healthcare information systems while providing modularity and accessibility.
Ackermann, Selina; Ghanim, Leyla; Heierle, Anette; Hertwig, Ralph; Langewitz, Wolf; Mata, Rui; Bingisser, Roland
This article examines the extent to which structuring Emergency Department discharge information improves the ability to recall that information, and whether such benefits interact with relevant prior knowledge. Using three samples of students with different levels of prior medical knowledge, we investigated the amount of information recalled after structured vs. non-structured presentation of information. Across all student samples, the structured discharge information led to a relative increase in recalled items of 17% compared to non-structured discharge information (M = 9.70, SD = 4.96 vs. M = 8.31, SD = 4.93). In the sample with least medical knowledge, however, the structured discharge information resulted in a relative increase in recall by 42% (M = 8.12 vs. M = 5.71). These results suggest that structuring discharge information can be a useful tool to improve recall of information and is likely to be most beneficial for patient populations with lower levels of medical knowledge.
Azzariti, Danielle R.; Riggs, Erin Rooney; Niehaus, Annie; Rodriguez, Laura Lyman; Ramos, Erin M.; Kattman, Brandi; Landrum, Melissa J.; Martin, Christa L.; Rehm, Heidi L.
Data sharing between laboratories, clinicians, researchers, and patients is essential for improvements and standardization in genomic medicine; encouraging genomic data sharing (GDS) is a key activity of the National Institutes of Health (NIH)-funded Clinical Genome Resource (ClinGen). The ClinGen initiative is dedicated to evaluating the clinical relevance of genes and variants for use in precision medicine and research. Currently, data originating from each of the aforementioned stakeholder groups is represented in ClinVar, a publicly available repository of genomic variation, and its relationship to human health hosted by the National Center for Biotechnology Information at the NIH. Although policies such as the 2014 NIH GDS policy are clear regarding the mandate for informed consent for broad data sharing from research participants, no clear guidance exists on the level of consent appropriate for the sharing of information obtained through clinical testing to advance knowledge. ClinGen has collaborated with ClinVar and the National Human Genome Research Institute to develop points to consider for clinical laboratories on sharing de-identified variant-level data in light of both the NIH GDS policy and the recent updates to the Common Rule. We propose specific data elements from interpreted genomic variants that are appropriate for submission to ClinVar when direct patient consent was not sought and describe situations in which obtaining informed consent is recommended. PMID:29437798
Li, Ju-Ping; Han, Wei; Gu, Shan-Zhi; Chen, Teng
Informed consent right is not just for basic ethical consideration, but is important for protecting patient's right by law, which is expressed through informed consent contract. The appraised individuals of forensic clinical examination have the similar legal status as the patients in medical system. However, the law does not require informed consent right for the appraised individuals. I recommend giving certain informed consent right to the appraised individuals in the forensic clinical examination. Under the contracted relationship with the institution, the appraised individuals could participate in the examination process, know the necessary information, and make a selected consent on the examination results, which can assure the justice and fairness of judicial examination procedure.
Full Text Available The effect of patient education before total knee arthroplasty (TKA is controversial. No consensus exists about the optimal content of educational interventions. In a previous study, we developed and validated an educational booklet on the peri-TKA management of knee osteoarthritis.Our primary purpose was to evaluate the impact of the educational booklet on knowledge among patients awaiting TKA.This randomized controlled single-blind trial evaluated standard information by the surgeon with or without delivery of the educational booklet 4-6 weeks before primary noncomplex TKA in patients aged 55-75 years with incapacitating knee osteoarthritis. Patients were enrolled at a French surgical center between June 2011 and January 2012. A patient knowledge score was determined at baseline, on the day before TKA, and 3-6 weeks after TKA, using a self-administered questionnaire developed for our previous study. The assessor was blinded to group assignment.Of 44 eligible patients, 42 were randomized, 22 to the intervention and 20 to the control group, all of whom were included in the analysis. The groups were comparable at baseline. The intervention was associated with significantly better patient knowledge scores.An educational booklet improves knowledge among patients awaiting TKA. A study assessing the impact of the booklet combined with a exercise program would be helpful.Level I, randomized controlled double-blind trial; see S1 CONSORT Checklist.clinicaltrials.gov #NCT01747759.
A main focus of this research paper is to investigate on the explanation of the ‘digital inequality’ or ‘digital divide’ by economic level and education standard of about 150 countries worldwide. Inequality regarding GDP per capita, literacy and the so-called UN Education Index seem to be important factors affecting ICT usage, in particular Internet penetration, mobile phone usage and also mobile Internet services. Empirical methods and (multivariate) regression analysis with linear and non-linear functions are useful methods to measure some crucial factors of a country or culture towards becoming information and knowledge based society. Overall, the study concludes that the convergence regarding ICT usage proceeds worldwide faster than the convergence in terms of economic wealth and education in general. The results based on a large data analysis show that the digital divide is declining over more than a decade between 2000 and 2013, since more people worldwide use mobile phones and the Internet. But a high digital inequality explained to a significant extent by the functional relation between technology penetration rates, education level and average income still exists. Furthermore it supports the actions of countries at UN/G20/OECD level for providing ICT access to all people for a more balanced world in context of sustainable development by postulating that policymakers need to promote comprehensive education worldwide by means of using ICT.
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Noda, Hiroyuki; Yamagishi, Kazumasa; Ikeda, Ai; Asada, Takashi; Iso, Hiroyasu
The aim of the present study was to develop a way of identifying dementia using clinical assessments made by primary care physicians under the existing medical care system in Japan. A total of 623 people aged ≥65 years underwent standard clinical assessments by primary care physicians under the long-term-care insurance program to determine their grade of activities of daily living related to dementia. To examine the validity of the diagnosis, neuropsychiatrists carried out further diagnosis of dementia for all the participants. We regarded the dementia patients who received care for disability under the long-term care insurance program as having disabling dementia. Multivariable odds ratio (95% confidence interval) in single-grade increments of the activity was 2.1 (1.7-2.5) for dementia and 2.8 (2.2-3.4) for disabling dementia. The grades ≥I and ≥IIa were near the upper-left corner in the receiver operating characteristic curves. Setting the cut-off point at grades ≥I or ≥IIa yielded a higher integrated discrimination improvement, suggesting a major improvement in reducing misclassification by using these cut-off points. When we used grades ≥I as the cut-off point, the sensitivity (95% confidence limits) was 65% (58-72%) and the specificity was 93% (91-96%) for dementia, and the corresponding values in grades ≥IIa were 54% (47-62%) and 96% (94-97%). The corresponding values for disabling dementia were 83% (76-90%), 92% (90-95%), 73% (65-80%) and 96% (94-97%). Our findings suggest that selection of grades ≥I or ≥IIa as the cut-off point would reduce instances of misclassification in the identification of dementia and disabling dementia. Geriatr Gerontol Int 2018; ••: ••-••. © 2018 Japan Geriatrics Society.
Kühne, Franziska; Ay, Destina Sevde; Otterbeck, Mara Jasmin; Weck, Florian
The use of simulated and standardized patients (SP) is widely accepted in the medical field and, from there, is beginning to disseminate into clinical psychology and psychotherapy. The purpose of this study was therefore to systematically review barriers and facilitators that should be considered in the implementation of SP interventions specific to clinical psychology and psychotherapy. Following current guidelines, a scoping review was conducted. The literature search focused on the MEDLINE, PsycINFO and Web of Science databases, including Dissertation Abstracts International. After screening for titles and abstracts, full texts were screened independently and in duplicate according to our inclusion criteria. For data extraction, a pre-defined form was piloted and used. Units of meaning with respect to barriers and facilitators were extracted and categorized inductively using content-analysis techniques. From the results, a matrix of interconnections and a network graph were compiled. The 41 included publications were mainly in the fields of psychiatry and mental health nursing, as well as in training and education. The detailed category system contrasts four supercategories, i.e., which organizational and economic aspects to consider, which persons to include as eligible SPs, how to develop adequate scenarios, and how to authentically and consistently portray mental health patients. Publications focused especially on the interrelation between authenticity and consistency of portrayals, on how to evoke empathy in learners, and on economic and training aspects. A variety of recommendations for implementing SP programs, from planning to training, monitoring, and debriefing, is provided, for example, ethical screening of and ongoing support for SPs.
Pflaum, H.; Guderian, J.; Kuemmel, R. [UMSICHT, Inst. fuer Umwelt-, Sicherheits- und Energietechnik e.V., Oberhausen (Germany)
Appropriate organization structures, environmental controlling systems, and corporate environmental information systems (CEIS) are generally considered to be the essential instruments of a modern environmental management. Frequently, acceptance problems have been observed with respect to the installation of a CEIS due to the facts that there are no legal demands to implement such a system and, on the other hand, that theoretically based definitions of standards and structural principles of an CEIS are not yet available. As a consequence, different isolated solutions with rather low efficiency were hurriedly implemented by various companies. Regarding more precise request profiles for CEI systems, the present paper deals with the structural environment and the priority targets of an enterprise and with the organizational integration of environmental tasks. The operationalization into typical function fields yields tools to derive rough enterprise models, to analyze information streams and to select environmentally relevant information as well as the routes which they tend to go. Based on these fundamental instruments, a CEIS architecture (structure and organization) can be developed whose realization is eventually supported by a ten-step plan. Existing EDP solutions are deliberately excluded in order to verify the general validity of the system architecture and to encourage creative potentials. The CEIS concept presented here, however, requires a transformation into operative practice, i.e. adjustment, completion, and combination of the elements concerning the detailed conditions of the enterprise under study. (orig.) [Deutsch] Als wesentliche Instrumente modernen Umweltmanagements werden gemeinhin eine entsprechend ausgerichtete Organisationsstruktur, ein Umweltcontrollingsystem (UCS) und ein betriebliches Umweltinformationssystem (BUIS) angesehen. Die Einfuehrung eines BUIS in Industrieunternehmen stoesst aber erfahrungsgemaess auf Akzeptanzschwierigkeiten. Dies
Liu, G.; Wu, C.; Li, X.; Song, P.
The 3D urban geological information system has been a major part of the national urban geological survey project of China Geological Survey in recent years. Large amount of multi-source and multi-subject data are to be stored in the urban geological databases. There are various models and vocabularies drafted and applied by industrial companies in urban geological data. The issues such as duplicate and ambiguous definition of terms and different coding structure increase the difficulty of information sharing and data integration. To solve this problem, we proposed a national standard-driven information classification and coding method to effectively store and integrate urban geological data, and we applied the data dictionary technology to achieve structural and standard data storage. The overall purpose of this work is to set up a common data platform to provide information sharing service. Research progresses are as follows: (1) A unified classification and coding method for multi-source data based on national standards. Underlying national standards include GB 9649-88 for geology and GB/T 13923-2006 for geography. Current industrial models are compared with national standards to build a mapping table. The attributes of various urban geological data entity models are reduced to several categories according to their application phases and domains. Then a logical data model is set up as a standard format to design data file structures for a relational database. (2) A multi-level data dictionary for data standardization constraint. Three levels of data dictionary are designed: model data dictionary is used to manage system database files and enhance maintenance of the whole database system; attribute dictionary organizes fields used in database tables; term and code dictionary is applied to provide a standard for urban information system by adopting appropriate classification and coding methods; comprehensive data dictionary manages system operation and security. (3
Lin, Yu-Kai; Chen, Hsinchun; Brown, Randall A
Temporal information extraction from clinical narratives is of critical importance to many clinical applications. We participated in the EVENT/TIMEX3 track of the 2012 i2b2 clinical temporal relations challenge, and presented our temporal information extraction system, MedTime. MedTime comprises a cascade of rule-based and machine-learning pattern recognition procedures. It achieved a micro-averaged f-measure of 0.88 in both the recognitions of clinical events and temporal expressions. We proposed and evaluated three time normalization strategies to normalize relative time expressions in clinical texts. The accuracy was 0.68 in normalizing temporal expressions of dates, times, durations, and frequencies. This study demonstrates and evaluates the integration of rule-based and machine-learning-based approaches for high performance temporal information extraction from clinical narratives. Copyright © 2013 Elsevier Inc. All rights reserved.
Lobach, David F.; Waters, Andrew; Silvey, Garry M.; Clark, Shelly J.; Kalyanaraman, Sri; Kawamoto, Kensaku; Lipkus, Isaac
Millions of consumers seek health information on the Internet. Unfortunately, this searching often falls short because of design limitations of many consumer-oriented Web sites. In this paper, we describe an approach that addresses several known barriers to consumer health information seeking. This approach primarily involves maintaining the referential context throughout a consumer’s search for information. To maintain referential context, this approach uses multiple levels of hierarchical constructs to organize complex information, and data elements are toggled to minimize the need for scrolling. An information resource based on this approach was implemented for information about smoking using standard Web technologies. The resource was evaluated by 31 diverse consumers through standardized usability instruments. Consumers found the resource to be easy to navigate and to use. We conclude that the approach described in this manuscript could be applied more broadly to facilitate the organization and presentation of consumer health information. PMID:20351884
Thomas, Shiny Sara; Mohanty, Soumyakant; Jayanthi, J. L.; Varughese, Jolly Mary; Balan, Anitha; Subhash, Narayanan
We present the clinical applicability of fluorescence ratio reference standard (FRRS) to discriminate different stages of dental caries. Toward this, laser-induced autofluorescence emission spectra are recorded in vivo in the 400- to 800-nm spectral range on a miniature fiber optic spectrometer from 65 patients, with a 404-nm diode laser as the excitation source. Autofluorescence spectra of sound teeth consist of a broad emission at 500 nm that is typical of natural enamel, whereas in caries teeth additional peaks are seen at 635 and 680 nm due to emission from porphyrin compounds in oral bacteria. Scatter plots are developed to differentiate sound teeth from enamel caries, sound teeth from dentinal caries, and enamel caries from dentinal caries using the mean fluorescence intensity (FI) and ratios F500/F635 and F500/F680 measured from 25 sites of sound teeth and 65 sites of carious teeth. The sensitivity and specificity of both the FI and FRRS are determined. It is observed that a diagnostic algorithm based on FRRS scatter plots is able to discriminate enamel caries from sound teeth, dentinal caries from sound teeth, and enamel from dentinal caries with overall sensitivities of 85, 100, and 88% and specificities of 90, 100, and 77%, respectively.
Kerbage, Hala; El Chammay, Rabih; Richa, Sami
Mental health legislation represents an important mean of protecting the rights of persons with mental disabilities by preventing human rights violations and discrimination and by legally reinforcing the objectives of a mental health policy. The last decade has seen significant changes in the laws relating to psychiatric practice all over the world, especially with the implementation of the Convention for the Rights of People with Disabilities (CRPD). In this paper, we review the existing legislation in Lebanon concerning the following areas in mental health: treatment and legal protection of persons with mental disabilities, criminal laws in relation to offenders with mental disorders, and laws regulating incapacity. We will discuss these texts in comparison with international recommendations and standards on the rights of persons with disabilities, showing the recurrent contradiction between them. Throughout our article, we will address the clinical dilemmas that Lebanese psychiatrists encounter in practice, in the absence of a clear legislation that can orient their decisions and protect their patients from abuse. Copyright © 2015. Published by Elsevier Ltd.
Han Jung Kim
Full Text Available In Korea, many stroke patients receive oriental medical care, in which pattern-identification plays a major role. Pattern-identification is Oriental Medicine's unique diagnostic system. This study attempted to standardize oriental medical pattern-identification for stroke patients. This was a community-based multicenter study that enrolled stroke patients within 30 days after their ictus. We assessed the patients' general characteristics and symptoms related to pattern-identification. Each patient's pattern was determined when two doctors had the same opinion. To determine which variables affect the pattern-identification, binary logistic regression analysis was used with the backward method. A total of 806 stroke patients were enrolled. Among 480 patients who were identified as having a certain pattern, 100 patients exhibited the Fire Heat Pattern, 210 patients the Phlegm Dampness Pattern, nine patients the Blood Stasis Pattern, 110 patients the Qi Deficiency Pattern, and 51 patients the Yin Deficiency Pattern. After the regression analysis, the predictive logistic equations for the Fire Heat, Phlegm Dampness, Qi Deficiency, and Yin Deficiency patterns were determined. The Blood Stasis Pattern was omitted because the sample size was too small. Predictive logistic equations were suggested for four of the patterns. These criteria would be useful in determining each stroke patient's pattern in clinics. However, further studies with large samples are necessary to validate and confirm these criteria.
Farajollahi A. R.
Full Text Available Introduction: In radiation therapy centers across Iran, protection of normal tissues is usually accomplished by either Cerrobend or lead block shielding. In this study, the influence of these two shielding methods on central axis dose distribution of photon beam a Cobalt unit was investigated in clinical conditions. Materials and Methods: All measurements were performed for 60Co γ-ray beams and the Cerrobend blocks were fabricated by commercial Cerrobend materials. Standard lead block shields belonged to Cobalt unit. Data was collected through a calibrated ionization chamber, relative dosimetry systems and a TLD dosimetery. Results: Results of the percent depth dose (PDD measurements at depths of 0.5, 1, 5, 10, 15 and 20 cm for 23 different field sizes of patients with head and neck cancer showed no significant differences between lead and Cerrobend shielding methods. Measurement results of absolute dosimetry in depths of 1.5, 3, 5, 7, 10 and 12 cm also showed no significant differences between these two shielding methods. The same results were obtained by TLD dosimetry on patient skin. Conclusion: Use of melt shielding methods is a very easy and fast shield-making technique with no differences in PDD, absolute and skin dose between lead and Cerrobend block shielding methods.
Hansen, Morten; Hjortø, Gertrud Malene; Donia, Marco
induction of type 1 effector T cells. Standard matured clinical grade DCs “sDCs” were compared with DCs matured with either of two type 1 polarizing maturation cocktails; the alpha-type-1 DCs “αDC1s” (TNF-α, IL-1β, IFN-γ, IFN-α, Poly(I:C)) and “mDCs” (monophosphoryl lipid A (MPL), IFN-γ) or a mixed cocktail....... αDC1s and mDCs were functionally superior to sDCs as they polarized naïve CD4+ T cells most efficiently into T helper type 1 effector cells and primed more functional MART-1 specific CD8+ T cells although with variation between donors. αDC1s and mDCs were transiently less capable of CCL21-directed......DCs and strikingly had the highest expression of the inhibitory molecules PD-L1 and CD25. Thus, further studies with type 1 polarized DCs are warranted for use in immunotherapy, but when combined with PGE2 as in mpDCs, they seems to be less optimal for maturation of DCs....
Adams, Nancy E.
Evidence-based practice (EBP), like information literacy, is concerned with an individual's knowledge, skills, and attitudes relating to using information. EBP is now a professional competency in fields as diverse as social work, nursing and allied health fields, and public policy. A comparison of the Association of College and Research Libraries'…
Lapina Svetlana Nikolaevna
Full Text Available This article examines the approaches to the definition of “information culture”, its components, the system of personal values needed to succeed in the information and professional activities, the problem of students’ information culture formation in the modern information society. The analysis of the implementation of the Federal state educational standard of vocational education in "teaching in primary schools" is held. The variable part cycles of the basic professional educational programs is distributed on the base of the local professional community’s research and additional competencies. Such subjects as “Russian language and Speech”, “The cultural world of students”, “Ethics in business communication” are introduced through the variable part of the educational standard. The general amount of hours for such subject as «Computer science, information and communication technology in the professional activity" is increased. The results of the special study reveal the level of information culture of the future primary school teachers. According to the results it can be concluded that insufficient level of information culture’s development is impossible for a successful career and self-fulfillment in the present conditions. The article proposes the directions for the formation of future primary school teachers’ information culture in the implementation of the federal state educational standard of vocational education. According to the results of this research it is possible to tell about the effectiveness of these directions’ implementation.
Светлана Николаевна Лапина
Full Text Available This article examines the approaches to the definition of “information culture”, its components, the system of personal values needed to succeed in the information and professional activities, the problem of students’ information culture formation in the modern information society. The analysis of the implementation of the Federal state educational standard of vocational education in "teaching in primary schools" is held. The variable part cycles of the basic professional educational programs is distributed on the base of the local professional community’s research and additional competencies. Such subjects as “Russian language and Speech”, “The cultural world of students”, “Ethics in business communication” are introduced through the variable part of the educational standard. The general amount of hours for such subject as «Computer science, information and communication technology in the professional activity" is increased. The results of the special study reveal the level of information culture of the future primary school teachers. According to the results it can be concluded that insufficient level of information culture’s development is impossible for a successful career and self-fulfillment in the present conditions. The article proposes the directions for the formation of future primary school teachers’ information culture in the implementation of the federal state educational standard of vocational education. According to the results of this research it is possible to tell about the effectiveness of these directions’ implementation.DOI: http://dx.doi.org/10.12731/2218-7405-2013-5-31
... productivity, improve profitability and enhance their economic competitiveness. The information collected will... record. Dated: September 3, 2010. Gwellnar Banks, Management Analyst, Office of the Chief Information...
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.
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
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
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.
Malau-Aduli, B.S.; Teague, P.A.; D'Souza, K.; Heal, C.; Turner, R.; Garne, D.L.; Vleuten, C. van der
BACKGROUND: A key issue underpinning the usefulness of the OSCE assessment to medical education is standard setting, but the majority of standard-setting methods remain challenging for performance assessment because they produce varying passing marks. Several studies have compared standard-setting
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.
Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian
The executive board of the Academy for Ethics in Medicine (AEM) and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation (including ethics consultation, ethics training and the establishment of policy guidelines) are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly.
... controls, systems and procedures of the information security program. The frequency and nature of such... information systems, and other arrangements in place to control risks. 3 3 See Security Guidelines, III.B. 2... Information Technology Examination Handbook, Information Security Booklet, Dec. 2002 available at http://www...
Gloria Willson, MLIS, MPH
Conclusions: The development of a rubric that dually assesses information literacy skills and maps relevant disciplinary competencies holds potential. This study offers a template for a rubric inspired by the ACRL Framework and outside professional standards. However, the overall low inter-rater reliability demands further calibration of the rubric. Following additional norming, this rubric can be used to help students identify the key information literacy competencies that they need in order to succeed as college students and future nurses. These skills include developing an authoritative voice, determining the scope of their information needs, and understanding the ramifications of their information choices.
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...
Saele, Hanne; Graabak, Ingeborg; Tangen, Grethe
The two-way communication towards the end consumer is in little use so far. There are probably several reasons for this but one important reason may be the lack of standardized interfaces for the information exchange towards the end user. The lack of such standards results in substantial system investment risks for the network companies because the systems may not be developed further and maintained should the deliverer leave the market. The communication channel Internet has expanded quickly and in Norway of today (1999) 25 to 30 % of the households have an Internet connection. The use of existing infrastructure and already tried out technology for information transferrals may contribute to making two-way communication more reasonable and functional. In the report various alternatives of standardized information exchange towards the end users are evaluated. Various formats are discussed with the following demands in mind: 1) Shall be suited for all types of communication media. 2) An international standard followed by everyone. 3) Reliable information transferral and flexible. The focus is on what kind of information is being transferred and how this is organized, and not on how the information is transferred. The discussed alternatives are evaluated both regarding traditional solutions for two- way communication and the use of the Internet. The following format alternatives are discussed: EDIEL/EDIFACT, ODEL(GS2), LonWorks/Echelon, UCA, DLMS/COSEM, COBRA and DCOM. The formats represent communication at various levels but they are mentioned in the report because they are often mentioned as possible standard formats towards the end user: ODEL, DLSM/COSEM and UCA. EDIEL is not suited for this interface. The market for two-way communication systems is international and it does not seem to be practical to establish a joint Norwegian/Swedish standard. The work with establishing one standard should therefore be continued through international standardization
Roberts, Kathryn L
Forty-five states and four U.S. territories have committed to implementing the new Common Core State Standards, with the goal of graduating students from our K-12 programs who are ready for college and careers. For many, the new standards represent a shift in genre focus, giving much more specific attention to informational genres. Beginning in the primary grades, the standards set high expectations for students' interaction with informational text, many of which are significantly more linguistically demanding than the standards that they replace. These increased demands are likely to pose difficulties not only for students currently receiving language support, but also for students without identified delays or disabilities. This article describes several of the kindergarten through fifth-grade standards related to informational text, highlighting the linguistic demands that each poses. In addition, instructional strategies are provided that teachers and speech-language pathologists can use to support the understanding and formulation of informational text for listening, reading, speaking, and writing. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
Full Text Available BACKGROUND: Traditionally, clinical research studies rely on collecting data with case report forms, which are subsequently entered into a database to create electronic records. Although well established, this method is time-consuming and error-prone. This study compares four electronic data capture (EDC methods with the conventional approach with respect to duration of data capture and accuracy. It was performed in a West African setting, where clinical trials involve data collection from urban, rural and often remote locations. METHODOLOGY/PRINCIPAL FINDINGS: Three types of commonly available EDC tools were assessed in face-to-face interviews; netbook, PDA, and tablet PC. EDC performance during telephone interviews via mobile phone was evaluated as a fourth method. The Graeco Latin square study design allowed comparison of all four methods to standard paper-based recording followed by data double entry while controlling simultaneously for possible confounding factors such as interview order, interviewer and interviewee. Over a study period of three weeks the error rates decreased considerably for all EDC methods. In the last week of the study the data accuracy for the netbook (5.1%, CI95%: 3.5-7.2% and the tablet PC (5.2%, CI95%: 3.7-7.4% was not significantly different from the accuracy of the conventional paper-based method (3.6%, CI95%: 2.2-5.5%, but error rates for the PDA (7.9%, CI95%: 6.0-10.5% and telephone (6.3%, CI95% 4.6-8.6% remained significantly higher. While EDC-interviews take slightly longer, data become readily available after download, making EDC more time effective. Free text and date fields were associated with higher error rates than numerical, single select and skip fields. CONCLUSIONS: EDC solutions have the potential to produce similar data accuracy compared to paper-based methods. Given the considerable reduction in the time from data collection to database lock, EDC holds the promise to reduce research
Podio, Fernando; Vollrath, William; Williams, Joel; Kobler, Ben; Crouse, Don
Sophisticated network storage management applications are rapidly evolving to satisfy a market demand for highly reliable data storage systems with large data storage capacities and performance requirements. To preserve a high degree of data integrity, these applications must rely on intelligent data storage devices that can provide reliable indicators of data degradation. Error correction activity generally occurs within storage devices without notification to the host. Early indicators of degradation and media error monitoring 333 and reporting (MEMR) techniques implemented in data storage devices allow network storage management applications to notify system administrators of these events and to take appropriate corrective actions before catastrophic errors occur. Although MEMR techniques have been implemented in data storage devices for many years, until 1996 no MEMR standards existed. In 1996 the American National Standards Institute (ANSI) approved the only known (world-wide) industry standard specifying MEMR techniques to verify stored data on optical disks. This industry standard was developed under the auspices of the Association for Information and Image Management (AIIM). A recently formed AIIM Optical Tape Subcommittee initiated the development of another data integrity standard specifying a set of media error monitoring tools and media error monitoring information (MEMRI) to verify stored data on optical tape media. This paper discusses the need for intelligent storage devices that can provide data integrity metadata, the content of the existing data integrity standard for optical disks, and the content of the MEMRI standard being developed by the AIIM Optical Tape Subcommittee.
... reduce unreasonable risks of burn injuries and deaths from fires associated with mattresses and mattress... resist ignition from a smoldering cigarette. The part 1632 standard requires manufacturers to perform... standard) under section 4 of the FFA to reduce deaths and injuries related to mattress fires, particularly...
Wada, Kyoko; Nisker, Jeff
The concept of a minimal risk threshold in research, beneath which exception to informed consent and ethics review processes may occur, has been codified for over 30 years in many national research regulations and by the Council for International Organizations of Medical Sciences. Although minimal risk in research constitutes one of the criteria for allowing waiver of informed consent or modification to the consent process and a large body of literature exists, discussion of a minimal risk threshold in clinical practice has not occurred. One reason for lack of discussion may be that implicit consent is accepted for a wide range of routine clinical practices. Extending the role of minimal risk in research to clinical practice might assist clinicians in identifying circumstances for which implicit consent is indeed sufficient and circumstances in which it is not. Further, concepts from minimal risk in research might assist clinicians regarding when information provision in health promotion is required. We begin by reviewing concepts in both minimal risk in research and informed choice in clinical practice. We then explore how a clinical minimal risk concept may clarify recommendations for information provision in clinical practice and support the patient's informed choice regarding therapeutic and diagnostic procedures and also health promotion. Given that clinical practice involves a broad scope of health information, professional practice guidelines on information provision based on the application of the minimal risk threshold in research could be developed to guide clinicians in what information must be provided to their patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Sakurai, Hiroaki; Kanada, Yoshikiyo; Sugiura, Yoshito; Motoya, Ikuo; Yamada, Masayuki; Tomita, Masao; Naka, Toru; Teranishi, Toshio; Tanabe, Shigeo; Tsujimura, Toru; Okanishi, Tetsuo
[Purpose] A major issue in physical/occupational therapist education is the improvement of students' clinical techniques. In this study, we introduced an education system using an Objective Structured Clinical Examination (OSCE), and made an attempt at standardization of its evaluation. [Subjects] The subjects were 227 students in the classes of 2008 to 2010 who enrolled at our university between 2004 and 2006, before the introduction of the education system using OSCE, and 221 students in the classes of 2011 to 2013 who enrolled between 2007 and 2009, after the introduction. [Methods] Performances in attitude and skills (performance in clinical training and OSCE) were compared between before and after the introduction of OSCE. OSCE results were compared between before and after clinical trainings at each OSCE Level; and the correlation of between performances in clinical training and OSCE was examined. [Results] Performances in OSCE and clinical training (attitude, skills) were improved by the introduction of the education system using OSCE, but no significant correlation was observed in the relationship between performances in OSCE and clinical training. [Conclusion] Further studies should be conducted aiming at the standardization of clinical skill evaluation in postgraduate education to establish an education system using OSCE.
Alisha M. Johnson
Full Text Available Respiratory clinical guidelines provide clinicians with evidence-based guidance for practice. Clinical guidelines also provide an opportunity to identify the knowledge and technical and non-technical skills required by respiratory ward-based registered nurses. The aim of this review was to use a systematic process to establish the core technical and non-technical skills and knowledge identified in evidence-based clinical guidelines that enable the care of hospitalised adult respiratory patients. 17 guidelines were identified in our systematic review. The quality assessment demonstrated variability in these guidelines. Common core knowledge and technical and non-technical skills were identified. These include pathophysiology, understanding of physiological measurements and monitoring, education, counselling, and ward and patient management. The knowledge and skills extracted from respiratory clinical guidelines may inform a curriculum for ward-based respiratory nursing to ensure optimal care of adult patients.
Johnson, Alisha M; Smith, Sheree M S
Respiratory clinical guidelines provide clinicians with evidence-based guidance for practice. Clinical guidelines also provide an opportunity to identify the knowledge and technical and non-technical skills required by respiratory ward-based registered nurses. The aim of this review was to use a systematic process to establish the core technical and non-technical skills and knowledge identified in evidence-based clinical guidelines that enable the care of hospitalised adult respiratory patients. 17 guidelines were identified in our systematic review. The quality assessment demonstrated variability in these guidelines. Common core knowledge and technical and non-technical skills were identified. These include pathophysiology, understanding of physiological measurements and monitoring, education, counselling, and ward and patient management. The knowledge and skills extracted from respiratory clinical guidelines may inform a curriculum for ward-based respiratory nursing to ensure optimal care of adult patients.
Montanarella, Luca; Wilson, Peter; Cox, Simon; McBratney, Alex; Ahamed, Sonya; McMillan, Bob; Jacquier, David; Fortner, Jim
There is an increasing need to collect, collate and share soil data and information within countries, across regions and globally. Timely access to consistent and authoritative data and information is critical to issues related to food production, climate change, water management, energy production and biodiversityl. Soil data and information is managed by numerous agencies and organisations using a plethora of processes, scales and standards. A number of national and international activities and projects are currently dealing with the issues associated with collation of disparate data sets. Standards are being developed for data storage, transfer and collation like, for example, in the GobalSoilMap.net project, e-SOTER and the EU Inspire GS-SOIL. Individually these will not provide a single internationally recognised and adopted standard for soil data and information exchange. A recent GlobalSoilMap.net meeting held in Wageningen, The Netherlands, discussed the needs of a harmonized information model for collation of a global 90 metre grid of key soil attributes (organic carbon, soil texture, pH, depth to bedrock/impeding layer, and predictions of bulk density and available water capacity) at six specified depth increments. The meeting considered a number of existing data base implementations (such as ASRIS, NASIS, WISE, SOTER) as well as emerging abstract information models that are being expressed in UML (such as e-SOTER). It examined related information models, such as GeoSciML and the lessons learnt in developing and implementing such community agreed models, features and vocabularies. There is a need to develop a global soil information standard, to be called SoilML, that would allow access and use of data across a broad range of international initiatives (such as GEOSS and INSPIRE) as well as supporting national, regional and local data interoperability and integration. The meeting agreed to adopt the interoperability approaches of formalising the
Josephson, Colin B; Engbers, Jordan D T; Sajobi, Tolulope T; Jette, Nathalie; Agha-Khani, Yahya; Federico, Paolo; Murphy, William; Pillay, Neelan; Wiebe, Samuel
Elderly onset epilepsy represents a distinct subpopulation that has received considerable attention due to the unique features of the disease in this age group. Research into this particular patient group has been limited by a lack of a standardized definition and understanding of the attributes associated with elderly onset epilepsy. We used a prospective cohort database to examine differences in patients stratified according to age of onset. Linear support vector machine learning incorporating all significant variables was used to predict age of onset according to prespecified thresholds. Sensitivity and specificity were calculated and plotted in receiver-operating characteristic (ROC) space. Feature coefficients achieving an absolute value of 0.25 or greater were graphed by age of onset to define how they vary with time. We identified 2,449 patients, of whom 149 (6%) had an age of seizure onset of 65 or older. Fourteen clinical variables had an absolute predictive value of at least 0.25 at some point over the age of epilepsy-onset spectrum. Area under the curve in ROC space was maximized between ages of onset of 65 and 70. Features identified through machine learning were frequently threshold specific and were similar, but not identical, to those revealed through simple univariable and multivariable comparisons. This study provides an empirical, clinically informed definition of "elderly onset epilepsy." If validated, an age threshold of 65-70 years can be used for future studies of elderly onset epilepsy and permits targeted interventions according to the patient's age of onset. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.
Lowry, Tina; Vreeman, Daniel J; Loo, George T; Delman, Bradley N; Thum, Frederick L; Slovis, Benjamin H; Shapiro, Jason S
Background A health information exchange (HIE)–based prior computed tomography (CT) alerting system may reduce avoidable CT imaging by notifying ordering clinicians of prior relevant studies when a study is ordered. For maximal effectiveness, a system would alert not only for prior same CTs (exams mapped to the same code from an exam name terminology) but also for similar CTs (exams mapped to different exam name terminology codes but in the same anatomic region) and anatomically proximate CTs (exams in adjacent anatomic regions). Notification of previous same studies across an HIE requires mapping of local site CT codes to a standard terminology for exam names (such as Logical Observation Identifiers Names and Codes [LOINC]) to show that two studies with different local codes and descriptions are equivalent. Notifying of prior similar or proximate CTs requires an additional mapping of exam codes to anatomic regions, ideally coded by an anatomic terminology. Several anatomic terminologies exist, but no prior studies have evaluated how well they would support an alerting use case. Objective The aim of this study was to evaluate the fitness of five existing standard anatomic terminologies to support similar or proximate alerts of an HIE-based prior CT alerting system. Methods We compared five standard anatomic terminologies (Foundational Model of Anatomy, Systematized Nomenclature of Medicine Clinical Terms, RadLex, LOINC, and LOINC/Radiological Society of North America [RSNA] Radiology Playbook) to an anatomic framework created specifically for our use case (Simple ANatomic Ontology for Proximity or Similarity [SANOPS]), to determine whether the existing terminologies could support our use case without modification. On the basis of an assessment of optimal terminology features for our purpose, we developed an ordinal anatomic terminology utility classification. We mapped samples of 100 random and the 100 most frequent LOINC CT codes to anatomic regions in each
Spyrou, Stergiani S; Berler, Alexander A; Bamidis, Panagiotis D
The 1st and 2nd Regional Health Care System Authority of Central Macedonia (1st and 2nd PeSY) are two of the seventeen Regional Healthcare System Authorities in Greece. Every single PeSY aims to improve the level of quality that health care organisations offer as well as to control the expenditure of health care services provided by the health care organisations, Hospitals and Primary Care Health units. There is currently an urgent need for Regional Health Authorities to deploy integrated healthcare information system, based on secure networks. The limited interoperability of current hospital information systems (HIS) poses a risk for the management of patient related information since there is a difficulty to transform processed data into useful information and knowledge. Thus, a pilot system was developed to achieve data integration record synchronisation using the Health Level 7 protocol between the existing HIS of two Hospitals of Thessaloniki and the central Offices of the PeSY. The pilot was funded by the Third Community Support Framework (jointly funded by EU and Greece) funds in order to prepare the forthcoming major healthcare IT projects in Greece. It is shown that such a system is pragmatic, achieves data integration and provides acceptable integration costs.
Macefield, Rhiannon C.; Blencowe, Natalie S.; Brookes, Sara T.; Blazeby, Jane M.
Purpose The CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs) in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the ‘take home’ message for clinicians to use in practice. Materials and Methods The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis) in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice. Results From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a “detailed”, “general”, or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30%) and 6 (16%) combined papers reported “detailed” PRO rationale and integrated interpretation of results although only 2 (14%) and 1 (7%) primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73%) and 3 (20%) achieving “detailed” rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2). Conclusion It is recommended that single
The Assay Development Working Group (ADWG) of the CPTAC Program is currently drafting a document to propose best practices for generation, quantification, storage, and handling of peptide standards used for mass spectrometry-based assays, as well as interpretation of quantitative proteomic data based on peptide standards. The ADWG is seeking input from commercial entities that provide peptide standards for mass spectrometry-based assays or that perform amino acid analysis.
...: Prevalence and Clinical Course of Depression Among Patients with Heart Failure, VA HSR&D, Nursing Research... practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4...
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…
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.
... system modifications are consistent with the Enterprise's information security program; v. Dual control... security program; and c. Regularly test the key controls, systems and procedures of the information... appropriate, the information security program in light of any relevant changes in technology, the sensitivity...
The EU Directive applicable to life insurance sets out what kind of information insurance companies must give to policyholders. It also allows Member States to impose broader information duties, provided that the information is necessary for the policyholder to understand the contract. In its ruling
... administrative fees for providing information and related services for nonprogram-related purposes. SUMMARY: We... providing information and related services for nonprogram purposes we provide to the public. Previously, the... will ensure fees are consistent and that we collect the full cost of supplying our information when a...
... full cost of supplying information when a request is for a purpose not directly related to the... administrative fees for providing information and related services for nonprogram-related purposes; announcing... of providing information and related services we provide to the public for nonprogram purposes. We...