Information architecture: Profile of adopted standards

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-09-01

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.

42 CFR 493.1457 - Standard; Clinical consultant responsibilities.

Science.gov (United States)

2010-10-01

... 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...

Detailed clinical models: representing knowledge, data and semantics in healthcare information technology.

Science.gov (United States)

Goossen, William T F

2014-07-01

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.

Building Standards based Science Information Systems: A Survey of ISO and other standards

Science.gov (United States)

King, Todd; Walker, Raymond

Science Information systems began with individual researchers maintaining personal collec-tions of data and managing them by using ad hoc, specialized approaches. Today information systems are an enterprise consisting of federated systems that manage and distribute both historical and contemporary data from distributed sources. Information systems have many components. Among these are metadata models, metadata registries, controlled vocabularies and ontologies which are used to describe entities and resources. Other components include services to exchange information and data; tools to populate the system and tools to utilize available resources. When constructing information systems today a variety of standards can be useful. The benefit of adopting standards is clear; it can shorten the design cycle, enhance software reuse and enable interoperability. We look at standards from the International Stan-dards Organization (ISO), International Telecommunication Union (ITU), Organization for the Advancement of Structured Information Standards (OASIS), Internet Engineering Task Force (IETF), American National Standards Institute (ANSI) which have influenced the develop-ment of information systems in the Heliophysics and Planetary sciences. No standard can solve the needs of every community. Individual disciplines often must fill the gap between general purpose standards and the unique needs of the discipline. To this end individual science dis-ciplines are developing standards, Examples include the International Virtual Observatory Al-liance (IVOA), Planetary Data System (PDS)/ International Planetary Data Alliance (IPDA), Dublin-Core Science, and the Space Physics Archive Search and Extract (SPASE) consortium. This broad survey of ISO and other standards provides some guidance for the development information systems. The development of the SPASE data model is reviewed and provides some insights into the value of applying appropriate standards and is used to illustrate

42 CFR 493.1419 - Standard; Clinical consultant responsibilities.

Science.gov (United States)

2010-10-01

... 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...

Compiling standardized information from clinical practice: using content analysis and ICF Linking Rules in a goal-oriented youth rehabilitation program.

Science.gov (United States)

Lustenberger, Nadia A; Prodinger, Birgit; Dorjbal, Delgerjargal; Rubinelli, Sara; Schmitt, Klaus; Scheel-Sailer, Anke

2017-09-23

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

A Standard, Knowledge Integrated Consultation Document for Pediatric HIV Information Exchange

Directory of Open Access Journals (Sweden)

Debkumar Patra

2011-01-01

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.

[The challenges of standardization in clinical diagnostic laboratories of medical organizations].

Science.gov (United States)

Men'shikov, V V

2013-04-01

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.

An integrated clinical and genomic information system for cancer precision medicine.

Science.gov (United States)

Jang, Yeongjun; Choi, Taekjin; Kim, Jongho; Park, Jisub; Seo, Jihae; Kim, Sangok; Kwon, Yeajee; Lee, Seungjae; Lee, Sanghyuk

2018-04-20

Increasing affordability of next-generation sequencing (NGS) has created an opportunity for realizing genomically-informed personalized cancer therapy as a path to precision oncology. However, the complex nature of genomic information presents a huge challenge for clinicians in interpreting the patient's genomic alterations and selecting the optimum approved or investigational therapy. An elaborate and practical information system is urgently needed to support clinical decision as well as to test clinical hypotheses quickly. Here, we present an integrated clinical and genomic information system (CGIS) based on NGS data analyses. Major components include modules for handling clinical data, NGS data processing, variant annotation and prioritization, drug-target-pathway analysis, and population cohort explorer. We built a comprehensive knowledgebase of genes, variants, drugs by collecting annotated information from public and in-house resources. Structured reports for molecular pathology are generated using standardized terminology in order to help clinicians interpret genomic variants and utilize them for targeted cancer therapy. We also implemented many features useful for testing hypotheses to develop prognostic markers from mutation and gene expression data. Our CGIS software is an attempt to provide useful information for both clinicians and scientists who want to explore genomic information for precision oncology.

Ontology-based information standards development

OpenAIRE

Heravi, Bahareh Rahmanzadeh

2012-01-01

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...

Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes.

Science.gov (United States)

Sharma, Deepak K; Solbrig, Harold R; Prud'hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

2016-01-01

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.

Peer Review of Clinical Information Models: A Web 2.0 Crowdsourced Approach.

Science.gov (United States)

Leslie, Heather; Ljosland Bakke, Silje

2017-01-01

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.

16 CFR 314.3 - Standards for safeguarding customer information.

Science.gov (United States)

2010-01-01

... 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...

Information systems as a quality management tool in clinical laboratories

Science.gov (United States)

Schmitz, Vanessa; Rosecler Bez el Boukhari, Marta

2007-11-01

This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system.

Information systems as a quality management tool in clinical laboratories

International Nuclear Information System (INIS)

Schmitz, Vanessa; Boukhari, Marta Rosecler Bez el

2007-01-01

This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system

Use of altered informed consent in pragmatic clinical research.

Science.gov (United States)

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

2015-10-01

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.

Tools in a clinical information system supporting clinical trials at a Swiss University Hospital.

Science.gov (United States)

Weisskopf, Michael; Bucklar, Guido; Blaser, Jürg

2014-12-01

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

Biodiversity information platforms: From standards to interoperability

Directory of Open Access Journals (Sweden)

Walter Berendsohn

2011-11-01

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.

42 CFR 493.1276 - Standard: Clinical cytogenetics.

Science.gov (United States)

2010-10-01

... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1276 Standard: Clinical cytogenetics. (a) The laboratory must have policies and procedures for ensuring accurate and reliable patient specimen identification during the process...

Applicability Evaluation of Job Standards for Diabetes Nutritional Management by Clinical Dietitian.

Science.gov (United States)

Baek, Young Jin; Oh, Na Gyeong; Sohn, Cheong-Min; Woo, Mi-Hye; Lee, Seung Min; Ju, Dal Lae; Seo, Jung-Sook

2017-04-01

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 dietitians of 40 tertiary hospitals, 47 general hospitals, and 9 hospitals. Based on each 5-point scale, the importance of overall duty was 4.4 ± 0.5, performance was 3.6 ± 0.8, and difficulty was 3.1 ± 0.7. 'Nutrition intervention' was 4.5 ± 0.5 for task importance, 'nutrition assessment' was 4.0 ± 0.7 for performance, and 'nutrition diagnosis' was 3.4 ± 0.9 for difficulty. These 3 items were high in each category. Based on the grid diagram, the tasks of both high importance and high performance were 'checking basic information,' 'checking medical history and therapy plan,' 'decision of nutritional needs,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.' The tasks with high importance but low performance were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'monitoring of nutrition intervention process.' The tasks of both high importance and high difficulty were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'supply of foods and nutrients,' 'education of nutrition and self-management,' and 'monitoring of nutrition intervention process.' The tasks of both high performance and high difficulty were 'documentation of nutrition assessment,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.'

Information technology-based standardized patient education in psychiatric inpatient care.

Science.gov (United States)

Anttila, Minna; Koivunen, Marita; Välimäki, Maritta

2008-10-01

This paper is a report of a study to describe nurses' experiences of information technology-based standardized patient education in inpatient psychiatric care. Serious mental health problems are an increasing global concern. Emerging evidence supports the implementation of practices that are conducive to patient self-management and improved patient outcomes among chronically ill patients with mental health problems. In contrast, the attitude of staff towards information technology has been reported to be contradictory in mental health care. After 1 year of using an Internet-based portal (Mieli.Net) developed for patients with schizophrenia spectrum psychosis, all 89 participating nurses were asked to complete questionnaires about their experiences. The data were collected in 2006. Fifty-six participants (63%) returned completed questionnaires and the data were analysed using content analysis. Nurses' experiences of the information technology-based standardized patient education were categorized into two major categories describing the advantages and obstacles in using information technology. Nurses thought that it brought the patients and nurses closer to each other and helped nurses to provide individual support for their patients. However, the education was time-consuming. Systematic patient education using information technology is a promising method of patient-centred care which supports nurses in their daily work. However, it must fit in with clinical activities, and nurses need some guidance in understanding its benefits. The study data can be used in policy-making when developing methods to improve the transparency of information provision in psychiatric nursing.

[Accreditation of clinical laboratories based on ISO standards].

Science.gov (United States)

Kawai, Tadashi

2004-11-01

International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

Standardizing the information architecture for spacecraft operations

Science.gov (United States)

Easton, C. R.

1994-01-01

This paper presents an information architecture developed for the Space Station Freedom as a model from which to derive an information architecture standard for advanced spacecraft. The information architecture provides a way of making information available across a program, and among programs, assuming that the information will be in a variety of local formats, structures and representations. It provides a format that can be expanded to define all of the physical and logical elements that make up a program, add definitions as required, and import definitions from prior programs to a new program. It allows a spacecraft and its control center to work in different representations and formats, with the potential for supporting existing spacecraft from new control centers. It supports a common view of data and control of all spacecraft, regardless of their own internal view of their data and control characteristics, and of their communications standards, protocols and formats. This information architecture is central to standardizing spacecraft operations, in that it provides a basis for information transfer and translation, such that diverse spacecraft can be monitored and controlled in a common way.

Standardized training in nurse model travel clinics.

Science.gov (United States)

Sofarelli, Theresa A; Ricks, Jane H; Anand, Rahul; Hale, Devon C

2011-01-01

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

Introducing Information Literacy Competency Standards for Nursing.

Science.gov (United States)

Phelps, Sue F; Hyde, Loree; Planchon Wolf, Julie

2015-01-01

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.

Implementing Home Health Standards in Clinical Practice.

Science.gov (United States)

Gorski, Lisa A

2016-02-01

In 1986, the American Nurses Association (ANA) published the first Standards of Home Health Practice. Revised in 1992 and expanded in 1999 to become Home Health Nursing: Scope and Standards of Practice, it was revised in 2008 and again in 2014. In the 2014 edition, there are 6 standards of home healthcare nursing practice and 10 standards of professional performance for home healthcare nursing. The focus of this article is to describe the home healthcare standards and to provide guidance for implementation in clinical practice. It is strongly encouraged that home healthcare administrators, educators, and staff obtain a copy of the standards and fully read this essential home healthcare resource.

Development of job standards for clinical nutrition therapy for dyslipidemia patients.

Science.gov (United States)

Kang, Min-Jae; Seo, Jung-Sook; Kim, Eun-Mi; Park, Mi-Sun; Woo, Mi-Hye; Ju, Dal-Lae; Wie, Gyung-Ah; Lee, Song-Mi; Cha, Jin-A; Sohn, Cheong-Min

2015-04-01

Dyslipidemia has significantly contributed to the increase of death and morbidity rates related to cardiovascular diseases. Clinical nutrition service provided by dietitians has been reported to have a positive effect on relief of medical symptoms or reducing the further medical costs. However, there is a lack of researches to identify key competencies and job standard for clinical dietitians to care patients with dyslipidemia. Therefore, the purpose of this study was to analyze the job components of clinical dietitian and develop the standard for professional practice to provide effective nutrition management for dyslipidemia patients. The current status of clinical nutrition therapy for dyslipidemia patients in hospitals with 300 or more beds was studied. After duty tasks and task elements of nutrition care process for dyslipidemia clinical dietitians were developed by developing a curriculum (DACUM) analysis method. The developed job standards were pretested in order to evaluate job performance, difficulty, and job standards. As a result, the job standard included four jobs, 18 tasks, and 53 task elements, and specific job description includes 73 basic services and 26 recommended services. When clinical dietitians managing dyslipidemia patients performed their practice according to this job standard for 30 patients the job performance rate was 68.3%. Therefore, the job standards of clinical dietitians for clinical nutrition service for dyslipidemia patients proposed in this study can be effectively used by hospitals.

Radiation information and informed consent for clinical trials

Energy Technology Data Exchange (ETDEWEB)

Caon, Martin [School of Nursing and Midwifery, Flinders University, Adelaide (Australia)], E-mail: martin.caon@flinders.edu.au

2008-09-01

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)

Radiation information and informed consent for clinical trials

International Nuclear Information System (INIS)

Caon, Martin

2008-01-01

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)

45 CFR 170.210 - Standards for health information technology to protect electronic health information created...

Science.gov (United States)

2010-10-01

... 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...

78 FR 43145 - Announcing Approval of Federal Information Processing Standard 186-4, Digital Signature Standard

Science.gov (United States)

2013-07-19

...-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...

Clinical decision support for whole genome sequence information leveraging a service-oriented architecture: a prototype.

Science.gov (United States)

Welch, Brandon M; Rodriguez-Loya, Salvador; Eilbeck, Karen; Kawamoto, Kensaku

2014-01-01

Whole genome sequence (WGS) information could soon be routinely available to clinicians to support the personalized care of their patients. At such time, clinical decision support (CDS) integrated into the clinical workflow will likely be necessary to support genome-guided clinical care. Nevertheless, developing CDS capabilities for WGS information presents many unique challenges that need to be overcome for such approaches to be effective. In this manuscript, we describe the development of a prototype CDS system that is capable of providing genome-guided CDS at the point of care and within the clinical workflow. To demonstrate the functionality of this prototype, we implemented a clinical scenario of a hypothetical patient at high risk for Lynch Syndrome based on his genomic information. We demonstrate that this system can effectively use service-oriented architecture principles and standards-based components to deliver point of care CDS for WGS information in real-time.

Using language models to identify relevant new information in inpatient clinical notes.

Science.gov (United States)

Zhang, Rui; Pakhomov, Serguei V; Lee, Janet T; Melton, Genevieve B

2014-01-01

Redundant information in clinical notes within electronic health record (EHR) systems is ubiquitous and may negatively impact the use of these notes by clinicians, and, potentially, the efficiency of patient care delivery. Automated methods to identify redundant versus relevant new information may provide a valuable tool for clinicians to better synthesize patient information and navigate to clinically important details. In this study, we investigated the use of language models for identification of new information in inpatient notes, and evaluated our methods using expert-derived reference standards. The best method achieved precision of 0.743, recall of 0.832 and F1-measure of 0.784. The average proportion of redundant information was similar between inpatient and outpatient progress notes (76.6% (SD=17.3%) and 76.7% (SD=14.0%), respectively). Advanced practice providers tended to have higher rates of redundancy in their notes compared to physicians. Future investigation includes the addition of semantic components and visualization of new information.

A system architecture for sharing de-identified, research-ready brain scans and health information across clinical imaging centers.

Science.gov (United States)

Chervenak, Ann L; van Erp, Theo G M; Kesselman, Carl; D'Arcy, Mike; Sobell, Janet; Keator, David; Dahm, Lisa; Murry, Jim; Law, Meng; Hasso, Anton; Ames, Joseph; Macciardi, Fabio; Potkin, Steven G

2012-01-01

Progress in our understanding of brain disorders increasingly relies on the costly collection of large standardized brain magnetic resonance imaging (MRI) data sets. Moreover, the clinical interpretation of brain scans benefits from compare and contrast analyses of scans from patients with similar, and sometimes rare, demographic, diagnostic, and treatment status. A solution to both needs is to acquire standardized, research-ready clinical brain scans and to build the information technology infrastructure to share such scans, along with other pertinent information, across hospitals. This paper describes the design, deployment, and operation of a federated imaging system that captures and shares standardized, de-identified clinical brain images in a federation across multiple institutions. In addition to describing innovative aspects of the system architecture and our initial testing of the deployed infrastructure, we also describe the Standardized Imaging Protocol (SIP) developed for the project and our interactions with the Institutional Review Board (IRB) regarding handling patient data in the federated environment.

Study on the standardization of hospital information system for medical image information sharing

International Nuclear Information System (INIS)

Kim, Seon Chil; Kwon, Su Ja

2001-01-01

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

76 FR 7817 - Announcing Draft Federal Information Processing Standard 180-4, Secure Hash Standard, and Request...

Science.gov (United States)

2011-02-11

...-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...

Personalized-Detailed Clinical Model for Data Interoperability Among Clinical Standards

OpenAIRE

Khan, Wajahat Ali; Hussain, Maqbool; Afzal, Muhammad; Amin, Muhammad Bilal; Saleem, Muhammad Aamir; Lee, Sungyoung

2013-01-01

Objective: Data interoperability among health information exchange (HIE) systems is a major concern for healthcare practitioners to enable provisioning of telemedicine-related services. Heterogeneity exists in these systems not only at the data level but also among different heterogeneous healthcare standards with which these are compliant. The relationship between healthcare organization data and different heterogeneous standards is necessary to achieve the goal of data level interoperabi...

BRIDG: a domain information model for translational and clinical protocol-driven research.

Science.gov (United States)

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

2017-09-01

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: journals.permissions@oup.com

Standardization in library and information science in selected European countries

Science.gov (United States)

Matysek, Anna

2015-02-01

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.

Standardized structure of electronic records for information exchange

International Nuclear Information System (INIS)

Galabova, Sevdalina; Trencheva, Tereza; Trenchev, Ivan

2009-01-01

In the paper is presented the structure of the electronic record whose form is standardized in ISO 2709:2008. This International Standard describes a generalized structure, a framework designed specially for communications between data processing systems and not for use as a processing format within systems.Basic terms are defined as follows: character, data field, directory, directory map, field, field separator etc. It’s presented the general structure of a record. The application analysis of this structure shows the effective information exchange in the widest range.The purpose of this research is to find out advantages and structure of the information exchange format standardized in ISO 2709:2008. Key words: Standardized structure, electronic records, exchange formats, data field, directory, directory map, indicators, identifiers

Rational clinical evaluation of suspected acute coronary syndromes: The value of more information.

Science.gov (United States)

Hancock, David G; Chuang, Ming-Yu Anthony; Bystrom, Rebecca; Halabi, Amera; Jones, Rachel; Horsfall, Matthew; Cullen, Louise; Parsonage, William A; Chew, Derek P

2017-12-01

Many meta-analyses have provided synthesised likelihood ratio data to aid clinical decision-making. However, much less has been published on how to safely combine clinical information in practice. We aimed to explore the benefits and risks of pooling clinical information during the ED assessment of suspected acute coronary syndrome. Clinical information on 1776 patients was collected within a randomised trial conducted across five South Australian EDs between July 2011 and March 2013. Bayes theorem was used to calculate patient-specific post-test probabilities using age- and gender-specific pre-test probabilities and likelihood ratios corresponding to the presence or absence of 18 clinical factors. Model performance was assessed as the presence of adverse cardiac outcomes among patients theoretically discharged at a post-test probability less than 1%. Bayes theorem-based models containing high-sensitivity troponin T (hs-troponin) outperformed models excluding hs-troponin, as well as models utilising TIMI and GRACE scores. In models containing hs-troponin, a plateau in improving discharge safety was observed after the inclusion of four clinical factors. Models with fewer clinical factors better approximated the true event rate, tended to be safer and resulted in a smaller standard deviation in post-test probability estimates. We showed that there is a definable point where additional information becomes uninformative and may actually lead to less certainty. This evidence supports the concept that clinical decision-making in the assessment of suspected acute coronary syndrome should be focused on obtaining the least amount of information that provides the highest benefit for informing the decisions of admission or discharge. © 2017 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

Audit, guidelines and standards: clinical governance for hip fracture care in Scotland.

Science.gov (United States)

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.

Patterns in Standards and Technologies for Economic Information Systems Interoperability

Directory of Open Access Journals (Sweden)

Vasile Irimia

2012-06-01

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.

A call for the adoption of nuclear utility information standards

International Nuclear Information System (INIS)

Slone, B.J. III; Richardson, C.E.

1993-01-01

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

Potential facilitators and barriers to adopting standard treatment guidelines in clinical practice.

Science.gov (United States)

Sharma, Sangeeta; Pandit, Ajay; Tabassum, Fauzia

2017-04-18

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

Aspects regarding the implementation of information security standards in organizations

Directory of Open Access Journals (Sweden)

Mihai Bârsan

2017-03-01

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.

Interoperability of medical device information and the clinical applications: an HL7 RMIM based on the ISO/IEEE 11073 DIM.

Science.gov (United States)

Yuksel, Mustafa; Dogac, Asuman

2011-07-01

Medical devices are essential to the practice of modern healthcare services. Their benefits will increase if clinical software applications can seamlessly acquire the medical device data. The need to represent medical device observations in a format that can be consumable by clinical applications has already been recognized by the industry. Yet, the solutions proposed involve bilateral mappings from the ISO/IEEE 11073 Domain Information Model (DIM) to specific message or document standards. Considering that there are many different types of clinical applications such as the electronic health record and the personal health record systems, the clinical workflows, and the clinical decision support systems each conforming to different standard interfaces, detailing a mapping mechanism for every one of them introduces significant work and, thus, limits the potential health benefits of medical devices. In this paper, to facilitate the interoperability of clinical applications and the medical device data, we use the ISO/IEEE 11073 DIM to derive an HL7 v3 Refined Message Information Model (RMIM) of the medical device domain from the HL7 v3 Reference Information Mode (RIM). This makes it possible to trace the medical device data back to a standard common denominator, that is, HL7 v3 RIM from which all the other medical domains under HL7 v3 are derived. Hence, once the medical device data are obtained in the RMIM format, it can easily be transformed into HL7-based standard interfaces through XML transformations because these interfaces all have their building blocks from the same RIM. To demonstrate this, we provide the mappings from the developed RMIM to some of the widely used HL7 v3-based standard interfaces.

Using Semantic Web technologies for the generation of domain-specific templates to support clinical study metadata standards.

Science.gov (United States)

Jiang, Guoqian; Evans, Julie; Endle, Cory M; Solbrig, Harold R; Chute, Christopher G

2016-01-01

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.

Identifying appropriate reference data models for comparative effectiveness research (CER) studies based on data from clinical information systems.

Science.gov (United States)

Ogunyemi, Omolola I; Meeker, Daniella; Kim, Hyeon-Eui; Ashish, Naveen; Farzaneh, Seena; Boxwala, Aziz

2013-08-01

The need for a common format for electronic exchange of clinical data prompted federal endorsement of applicable standards. However, despite obvious similarities, a consensus standard has not yet been selected in the comparative effectiveness research (CER) community. Using qualitative metrics for data retrieval and information loss across a variety of CER topic areas, we compare several existing models from a representative sample of organizations associated with clinical research: the Observational Medical Outcomes Partnership (OMOP), Biomedical Research Integrated Domain Group, the Clinical Data Interchange Standards Consortium, and the US Food and Drug Administration. While the models examined captured a majority of the data elements that are useful for CER studies, data elements related to insurance benefit design and plans were most detailed in OMOP's CDM version 4.0. Standardized vocabularies that facilitate semantic interoperability were included in the OMOP and US Food and Drug Administration Mini-Sentinel data models, but are left to the discretion of the end-user in Biomedical Research Integrated Domain Group and Analysis Data Model, limiting reuse opportunities. Among the challenges we encountered was the need to model data specific to a local setting. This was handled by extending the standard data models. We found that the Common Data Model from the OMOP met the broadest complement of CER objectives. Minimal information loss occurred in mapping data from institution-specific data warehouses onto the data models from the standards we assessed. However, to support certain scenarios, we found a need to enhance existing data dictionaries with local, institution-specific information.

Policy, Procedures and Standards for Enterprise Information Management

Science.gov (United States)

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.

Annotating temporal information in clinical narratives.

Science.gov (United States)

Sun, Weiyi; Rumshisky, Anna; Uzuner, Ozlem

2013-12-01

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.

Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

Science.gov (United States)

Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

2017-10-01

Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

77 FR 72702 - Small Business Size Standards: Information

Science.gov (United States)

2012-12-06

... 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 Business Administration (SBA) is increasing the receipts based small business size standards for 15...

Deficiencies in the transfer and availability of clinical trials evidence: a review of existing systems and standards

Directory of Open Access Journals (Sweden)

Valkenhoef Gert

2012-09-01

Full Text Available Abstract Background Decisions concerning drug safety and efficacy are generally based on pivotal evidence provided by clinical trials. Unfortunately, finding the relevant clinical trials is difficult and their results are only available in text-based reports. Systematic reviews aim to provide a comprehensive overview of the evidence in a specific area, but may not provide the data required for decision making. Methods We review and analyze the existing information systems and standards for aggregate level clinical trials information from the perspective of systematic review and evidence-based decision making. Results The technology currently used has major shortcomings, which cause deficiencies in the transfer, traceability and availability of clinical trials information. Specifically, data available to decision makers is insufficiently structured, and consequently the decisions cannot be properly traced back to the underlying evidence. Regulatory submission, trial publication, trial registration, and systematic review produce unstructured datasets that are insufficient for supporting evidence-based decision making. Conclusions The current situation is a hindrance to policy decision makers as it prevents fully transparent decision making and the development of more advanced decision support systems. Addressing the identified deficiencies would enable more efficient, informed, and transparent evidence-based medical decision making.

Organizational, technical, physical and clinical quality standards for radiotherapy

Science.gov (United States)

Bogusz-Czerniewicz, Marta; Kaźmierczak, Daniel

2012-01-01

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

78 FR 66655 - Consumer Information; Uniform Tire Quality Grading Standards

Science.gov (United States)

2013-11-06

... information indicating the relative performance of passenger car tires in the areas of treadwear, traction... [Docket No. NHTSA-2013-0120] RIN 2127-AL49 Consumer Information; Uniform Tire Quality Grading Standards...). ACTION: Interim final rule; request for comments. SUMMARY: The Uniform Tire Quality Grading Standards...

Standardization of Data for Clinical Use and Research in Spinal Cord Injury

Science.gov (United States)

Biering-Sørensen, Fin; Noonan, Vanessa K.

2016-01-01

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

"Heidelberg standard examination" and "Heidelberg standard procedures" - Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education.

Science.gov (United States)

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

2016-01-01

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.

Standards vs. labels with imperfect competition and asymmetric information

DEFF Research Database (Denmark)

Baltzer, Kenneth Thomas

2012-01-01

I demonstrate that providing information about product quality is not necessarily the best way to address asymmetric information problems when markets are imperfectly competitive. In a vertical differentiation model I show that a Minimum Quality Standard, which retains asymmetric information...

Standards vs. labels with imperfect competition and asymmetric information

DEFF Research Database (Denmark)

Baltzer, Kenneth Thomas

I demonstrate that providing information about product quality is not necessarily the best way to address asymmetric information problems when markets are imperfectly competitive. In a vertical dierentiation model I show that a Minimum Quality Standard, which retains asymmetric information...

Preferred information sources for clinical decision making: critical care nurses' perceptions of information accessibility and usefulness.

Science.gov (United States)

Marshall, Andrea P; West, Sandra H; Aitken, Leanne M

2011-12-01

Variability in clinical practice may result from the use of diverse information sources to guide clinical decisions. In routine clinical practice, nurses privilege information from colleagues over more formal information sources. It is not clear whether similar information-seeking behaviour is exhibited when critical care nurses make decisions about a specific clinical practice, where extensive practice variability exists alongside a developing research base. This study explored the preferred sources of information intensive care nurses used and their perceptions of the accessibility and usefulness of this information for making decisions in clinically uncertain situations specific to enteral feeding practice. An instrumental case study design, incorporating concurrent verbal protocols, Q methodology and focus groups, was used to determine intensive care nurses' perspectives of information use in the resolution of clinical uncertainty. A preference for information from colleagues to support clinical decisions was observed. People as information sources were considered most useful and most accessible in the clinical setting. Text and electronic information sources were seen as less accessible, mainly because of the time required to access the information within the documents. When faced with clinical uncertainty, obtaining information from colleagues allows information to be quickly accessed and applied within the context of a specific clinical presentation. Seeking information from others also provides opportunities for shared decision-making and potential validation of clinical judgment, although differing views may exacerbate clinical uncertainty. The social exchange of clinical information may meet the needs of nurses working in a complex, time-pressured environment but the extent of the evidence base for information passed through verbal communication is unclear. The perceived usefulness and accessibility of information is premised on the ease of use and access

77 FR 69441 - Federal Acquisition Regulation; Information Collection; Cost Accounting Standards Administration

Science.gov (United States)

2012-11-19

...; 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...

A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

Science.gov (United States)

Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

2013-01-01

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

Information disclosure in clinical informed consent: "reasonable" patient's perception of norm in high-context communication culture.

Science.gov (United States)

Hammami, Muhammad M; Al-Jawarneh, Yussuf; Hammami, Muhammad B; Al Qadire, Mohammad

2014-01-10

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 s name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p 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.

Establishment of Requirements and Methodology for the Development and Implementation of GreyMatters, a Memory Clinic Information System.

Science.gov (United States)

Tapuria, Archana; Evans, Matt; Curcin, Vasa; Austin, Tony; Lea, Nathan; Kalra, Dipak

2017-01-01

The aim of the paper is to establish the requirements and methodology for the development process of GreyMatters, a memory clinic system, outlining the conceptual, practical, technical and ethical challenges, and the experiences of capturing clinical and research oriented data along with the implementation of the system. The methodology for development of the information system involved phases of requirements gathering, modeling and prototype creation, and 'bench testing' the prototype with experts. The standard Institute of Electrical and Electronics Engineers (IEEE) recommended approach for the specifications of software requirements was adopted. An electronic health record (EHR) standard, EN13606 was used, and clinical modelling was done through archetypes and the project complied with data protection and privacy legislation. The requirements for GreyMatters were established. Though the initial development was complex, the requirements, methodology and standards adopted made the construction, deployment, adoption and population of a memory clinic and research database feasible. The electronic patient data including the assessment scales provides a rich source of objective data for audits and research and to establish study feasibility and identify potential participants for the clinical trials. The establishment of requirements and methodology, addressing issues of data security and confidentiality, future data compatibility and interoperability and medico-legal aspects such as access controls and audit trails, led to a robust and useful system. The evaluation supports that the system is an acceptable tool for clinical, administrative, and research use and forms a useful part of the wider information architecture.

Adapting the CUAHSI Hydrologic Information System to OGC standards

Science.gov (United States)

Valentine, D. W.; Whitenack, T.; Zaslavsky, I.

2010-12-01

The CUAHSI Hydrologic Information System (HIS) provides web and desktop client access to hydrologic observations via water data web services using an XML schema called “WaterML”. The WaterML 1.x specification and the corresponding Water Data Services have been the backbone of the HIS service-oriented architecture (SOA) and have been adopted for serving hydrologic data by several federal agencies and many academic groups. The central discovery service, HIS Central, is based on an metadata catalog that references 4.7 billion observations, organized as 23 million data series from 1.5 million sites from 51 organizations. Observations data are published using HydroServer nodes that have been deployed at 18 organizations. Usage of HIS has increased by 8x from 2008 to 2010, and doubled in usage from 1600 data series a day in 2009 to 3600 data series a day in the first half of 2010. The HIS central metadata catalog currently harvests information from 56 Water Data Services. We collaborate on the catalog updates with two federal partners, USGS and US EPA: their data series are periodically reloaded into the HIS metadata catalog. We are pursuing two main development directions in the HIS project: Cloud-based computing, and further compliance with Open Geospatial Consortium (OGC) standards. The goal of moving to cloud-computing is to provide a scalable collaborative system with a simpler deployment and less dependence of hardware maintenance and staff. This move requires re-architecting the information models underlying the metadata catalog, and Water Data Services to be independent of the underlying relational database model, allowing for implementation on both relational databases, and cloud-based processing systems. Cloud-based HIS central resources can be managed collaboratively; partners share responsibility for their metadata by publishing data series information into the centralized catalog. Publishing data series will use REST-based service interfaces, like OData

International Standardization of the Clinical Dosimetry of Beta Radiation Brachytherapy Sources: Progress of an ISO Standard

Science.gov (United States)

Soares, Christopher

2006-03-01

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.

Developing a Workflow Composite Score to Measure Clinical Information Logistics. A Top-down Approach.

Science.gov (United States)

Liebe, J D; Hübner, U; Straede, M C; Thye, J

2015-01-01

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.

Description and status update on GELLO: a proposed standardized object-oriented expression language for clinical decision support.

Science.gov (United States)

Sordo, Margarita; Boxwala, Aziz A; Ogunyemi, Omolola; Greenes, Robert A

2004-01-01

A major obstacle to sharing computable clinical knowledge is the lack of a common language for specifying expressions and criteria. Such a language could be used to specify decision criteria, formulae, and constraints on data and action. Al-though the Arden Syntax addresses this problem for clinical rules, its generalization to HL7's object-oriented data model is limited. The GELLO Expression language is an object-oriented language used for expressing logical conditions and computations in the GLIF3 (GuideLine Interchange Format, v. 3) guideline modeling language. It has been further developed under the auspices of the HL7 Clinical Decision Support Technical Committee, as a proposed HL7 standard., GELLO is based on the Object Constraint Language (OCL), because it is vendor-independent, object-oriented, and side-effect-free. GELLO expects an object-oriented data model. Although choice of model is arbitrary, standardization is facilitated by ensuring that the data model is compatible with the HL7 Reference Information Model (RIM).

Developing and enforcing internal information systems standards: InduMaker’s Standards Management Process

Directory of Open Access Journals (Sweden)

Claudia Loebbecke

2016-01-01

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.

Topic maps standard and its application in library and information science

Directory of Open Access Journals (Sweden)

Fatemeh Baji

2014-09-01

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.

Clinical balance assessment: perceptions of commonly-used standardized measures and current practices among physiotherapists in Ontario, Canada.

Science.gov (United States)

Sibley, Kathryn M; Straus, Sharon E; Inness, Elizabeth L; Salbach, Nancy M; Jaglal, Susan B

2013-03-20

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

Enhancing translation: guidelines for standard pre-clinical experiments in mdx mice.

Science.gov (United States)

Willmann, Raffaella; De Luca, Annamaria; Benatar, Michael; Grounds, Miranda; Dubach, Judith; Raymackers, Jean-Marc; Nagaraju, Kanneboyina

2012-01-01

Duchenne Muscular Dystrophy is an X-linked disorder that affects boys and leads to muscle wasting and death due to cardiac involvement and respiratory complications. The cause is the absence of dystrophin, a large structural protein indispensable for muscle cell function and viability. The mdx mouse has become the standard animal model for pre-clinical evaluation of potential therapeutic treatments. Recent years have seen a rapid increase in the number of experimental compounds being evaluated in the mdx mouse. There is, however, much variability in the design of these pre-clinical experimental studies. This has made it difficult to interpret and compare published data from different laboratories and to evaluate the potential of a treatment for application to patients. The authors therefore propose the introduction of a standard study design for the mdx mouse model. Several aspects, including animal care, sampling times and choice of tissues, as well as recommended endpoints and methodologies are addressed and, for each aspect, a standard procedure is proposed. Testing of all new molecules/drugs using a widely accepted and agreed upon standard experimental protocol would greatly improve the power of pre-clinical experimentations and help identifying promising therapies for the translation into clinical trials for boys with Duchenne Muscular Dystrophy. Copyright © 2011 Elsevier B.V. All rights reserved.

A clinical investigation of motivation to change standards and cognitions about failure in perfectionism.

Science.gov (United States)

Egan, Sarah J; Piek, Jan P; Dyck, Murray J; Rees, Clare S; Hagger, Martin S

2013-10-01

Clinical perfectionism is a transdiagnostic process that has been found to maintain eating disorders, anxiety disorders and depression. Cognitive behavioural models explaining the maintenance of clinical perfectionism emphasize the contribution of dichotomous thinking and resetting standards higher following both success and failure in meeting their goals. There has been a paucity of research examining the predictions of the models and motivation to change perfectionism. Motivation to change is important as individuals with clinical perfectionism often report many perceived benefits of their perfectionism; they are, therefore, likely to be ambivalent regarding changing perfectionism. The aim was to compare qualitative responses regarding questions about motivation to change standards and cognitions regarding failure to meet a personal standard in two contrasting groups with high and low negative perfectionism. Negative perfectionism refers to concern over not meeting personal standards. A clinical group with a range of axis 1 diagnoses who were elevated on negative perfectionism were compared to a group of athletes who were low on negative perfectionism. Results indicated that the clinical group perceived many negative consequences of their perfectionism. They also, however, reported numerous benefits and the majority stated that they would prefer not to change their perfectionism. The clinical group also reported dichotomous thinking and preferring to either keep standards the same or reset standards higher following failure, whilst the athlete group reported they would keep standards the same or set them lower. The findings support predictions of the cognitive behavioural model of clinical perfectionism.

A generic, web-based clinical information system architecture using HL7 CDA: successful implementation in dermatological routine care.

Science.gov (United States)

Schuler, Thilo; Boeker, Martin; Klar, Rüdiger; Müller, Marcel

2007-01-01

The requirements of highly specialized clinical domains are often underrepresented in hospital information systems (HIS). Common consequences are that documentation remains to be paper-based or external systems with insufficient HIS integration are used. This paper presents a solution to overcome this deficiency in the form of a generic framework based on the HL7 Clinical Document Architecture. The central architectural idea is the definition of customized forms using a schema-controlled XML language. These flexible form definitions drive the user interface, the data storage, and standardized data exchange. A successful proof-of-concept application in a dermatologic outpatient wound care department has been implemented, and is well accepted by the clinicians. Our work with HL7 CDA revealed the need for further practical research in the health information standards realm.

Evaluating standard terminologies for encoding allergy information.

Science.gov (United States)

Goss, Foster R; Zhou, Li; Plasek, Joseph M; Broverman, Carol; Robinson, George; Middleton, Blackford; Rocha, Roberto A

2013-01-01

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.

The New ACRL Information Literacy Competency Standards: Revising Reception

Science.gov (United States)

Harris, Benjamin R.

2013-01-01

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…

Minimum reporting standards for clinical research on groin pain in athletes

DEFF Research Database (Denmark)

Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M

2015-01-01

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...... 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...

Standard requirements for GCP-compliant data management in multinational clinical trials

LENUS (Irish Health Repository)

Ohmann, Christian

2011-03-22

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

Changes in information behavior in clinical teams after introduction of a clinical librarian service

Science.gov (United States)

Urquhart, Christine; Turner, Janet; Durbin, Jane; Ryan, Jean

2007-01-01

Objectives: The eighteen-month evaluation of a clinical librarian project (October 2003–March 2005) conducted in North Wales, United Kingdom (UK) assessed the benefits of clinical librarian support to clinical teams, the impact of mediated searching services, and the effectiveness of information skills training, including journal club support. Methods: The evaluation assessed changes in teams' information-seeking behavior and their willingness to delegate searching to a clinical librarian. Baseline (n = 69 responses, 73% response rate) and final questionnaire (n = 57, 77% response rate) surveys were complemented by telephone and face-to-face interviews (n = 33) among 3 sites served. Those attending information skills training sessions (n = 130) completed evaluations at the session and were surveyed 1 month after training (n = 24 questionnaire responses, n = 12 interviews). Results: Health professionals in clinical teams reported that they were more willing to undertake their own searching, but also more willing to delegate some literature searching, than at the start of the project. The extent of change depended on the team and the type of information required. Information skills training was particularly effective when organized around journal clubs. Conclusions: Collaboration with a clinical librarian increased clinician willingness to seek information. Clinical librarian services should leverage structured training opportunities such as journal clubs. PMID:17252062

Implementation of standards within eLearning information systems

Directory of Open Access Journals (Sweden)

Roman Malo

2007-01-01

Full Text Available Nowadays, eLearning standards' support within eLearning systems is much discussed problem. In this problem domain especially the reference model SCORM must be considered. This de-facto standard is a package of common standards and specifications used for the standardization of eLearning activities as eLearning content preparation, using e-course, communication etc. Implementation of standards itself is a process with great difficulty and time requests. Interesting and considerable approach to this problem is dividing all the process into several standalone and isolated steps focused on the individual segments of standards. This concept, in the paper described as 4-tier model of eLearning standards’ implementation, principally based upon the SCORM model enables sequential implementation of support for standards of eLearning metadata, eLearning content and also communication and navigation in e-courses. This possibility leads to portability and independence of result e-content. Discuss concept is a framework for standardization within eLearning subsystem of University Information System at Mendel University in Brno.

The need for international standardization in clinical beta dosimetry for brachytherapy

International Nuclear Information System (INIS)

Quast, U.; Boehm, J.; Kaulich, T.W.

2002-01-01

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

77 FR 62433 - Hazard Communication Standard; Approval of Information Collection Requirements

Science.gov (United States)

2012-10-15

... safety data sheets (SDSs). The final standard harmonizes the U.S. system with international norms and as.... ACTION: Final rule; notice of the Office of Management and Budget's (OMB) approval of information... FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate of Standards and Guidance, OSHA, U.S...

77 FR 50757 - Charging Standard Administrative Fees for Nonprogram-Related Information

Science.gov (United States)

2012-08-22

... are announcing the standardized administrative fees we will charge to recover our full cost of... will ensure fees are consistent and that we collect the full cost of supplying our information when a... standard fees that are calculated to reflect the full cost of providing information for nonprogram-related...

Informed consent for clinical trials: a comparative study of standard versus simplified forms.

Science.gov (United States)

Davis, T C; Holcombe, R F; Berkel, H J; Pramanik, S; Divers, S G

1998-05-06

A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills. During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why. Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (Pinformed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

Standardized cardiovascular data for clinical research, registries, and patient care: a report from the Data Standards Workgroup of the National Cardiovascular Research Infrastructure project.

Science.gov (United States)

Anderson, H Vernon; Weintraub, William S; Radford, Martha J; Kremers, Mark S; Roe, Matthew T; Shaw, Richard E; Pinchotti, Dana M; Tcheng, James E

2013-05-07

Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nonetheless, these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the 2 major technical standards organizations in health care, the Clinical Data Interchange Standards Consortium and Health Level Seven International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care

Electronic Information Standards to Support Obesity Prevention and Bridge Services Across Systems, 2010-2015.

Science.gov (United States)

Wiltz, Jennifer L; Blanck, Heidi M; Lee, Brian; Kocot, S Lawrence; Seeff, Laura; McGuire, Lisa C; Collins, Janet

2017-10-26

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.

Toward Clarity in Clinical Vitamin D Status Assessment: 25(OH)D Assay Standardization.

Science.gov (United States)

Binkley, Neil; Carter, Graham D

2017-12-01

Widespread variation in 25-hydroxyvitamin D (25(OH)D) assays continues to compromise efforts to develop clinical and public health guidelines regarding vitamin D status. The Vitamin D Standardization Program helps alleviate this problem. Reference measurement procedures and standard reference materials have been developed to allow current, prospective, and retrospective standardization of 25(OH)D results. Despite advances in 25(OH)D measurement, substantial variability in clinical laboratory 25(OH)D measurement persists. Existing guidelines have not used standardized data and, as a result, it seems unlikely that consensus regarding definitions of vitamin D deficiency, inadequacy, sufficiency, and excess will soon be reached. Until evidence-based consensus is reached, a reasonable clinical approach is advocated. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical Information Support System (CISS)

Data.gov (United States)

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...

Clinical Image Evaluation of Film Mammograms in Korea: Comparison with the ACR Standard

International Nuclear Information System (INIS)

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

2013-01-01

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

Information management to enable personalized medicine: stakeholder roles in building clinical decision support.

Science.gov (United States)

Downing, Gregory J; Boyle, Scott N; Brinner, Kristin M; Osheroff, Jerome A

2009-10-08

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

Information management to enable personalized medicine: stakeholder roles in building clinical decision support

Directory of Open Access Journals (Sweden)

Brinner Kristin M

2009-10-01

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

77 FR 13294 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure...

Science.gov (United States)

2012-03-06

...-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...

WE-F-BRB-01: The Power of Ontologies and Standardized Terminologies for Capturing Clinical Knowledge

Energy Technology Data Exchange (ETDEWEB)

Gabriel, P. [University of Pennsylvania (United States)

2015-06-15

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.

WE-F-BRB-01: The Power of Ontologies and Standardized Terminologies for Capturing Clinical Knowledge

International Nuclear Information System (INIS)

Gabriel, P.

2015-01-01

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

Using information management to implement a clinical resource management program.

Science.gov (United States)

Rosenstein, A H

1997-12-01

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.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

Science.gov (United States)

Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

2016-12-01

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

Understanding information retrieval systems management, types, and standards

CERN Document Server

Bates, Marcia J

2011-01-01

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

77 FR 54163 - Health Information Technology: Standards, Implementation Specifications, and Certification...

Science.gov (United States)

2012-09-04

... 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...

“Heidelberg standard examination” and “Heidelberg standard procedures” – Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education

Science.gov (United States)

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.

2016-01-01

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. PMID:27579354

Diabetes prevention information in Japanese magazines with the largest print runs. Content analysis using clinical guidelines as a standard.

Science.gov (United States)

Noda, Emi; Mifune, Taka; Nakayama, Takeo

2013-01-01

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.

77 FR 52692 - NIST Federal Information Processing Standard (FIPS) 140-3 (Second Draft), Security Requirements...

Science.gov (United States)

2012-08-30

...-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...

Certifying a university ENT clinic using the ISO 9001:2000 international standard.

Science.gov (United States)

Helbig, Matthias; Helbig, Silke; Kahla-Witzsch, Heike A; Kroll, Tobias; May, Angelika

2010-01-01

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.

Visualizing and Validating Metadata Traceability within the CDISC Standards.

Science.gov (United States)

Hume, Sam; Sarnikar, Surendra; Becnel, Lauren; Bennett, Dorine

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information.

The NIAID Division of AIDS enterprise information system: integrated decision support for global clinical research programs

Science.gov (United States)

Gupta, Nitin; Varghese, Suresh; Virkar, Hemant

2011-01-01

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. PMID:21816958

Medical Paraclinical Standards, Political Economy of Clinic, and Patients’ Clinical Dependency; A Critical Conversation Analysis of Clinical Counseling in South of Iran

Science.gov (United States)

Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

2014-01-01

Background: Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. Methods: The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. Results: Results show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Conclusion: Although we can’t condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can’t reduce it to instrumental and linear methods of body treatment. PMID:25349858

Medical paraclinical standards, political economy of clinic, and patients' clinical dependency; a critical conversation analysis of clinical counseling in South of iran.

Science.gov (United States)

Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

2014-07-01

Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. RESULTS show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Although we can't condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can't reduce it to instrumental and linear methods of body treatment.

Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure.

Science.gov (United States)

Dranseika, Vilius; Piasecki, Jan; Waligora, Marcin

2017-02-01

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups.

Implementing healthcare information security: standards can help.

Science.gov (United States)

Orel, Andrej; Bernik, Igor

2013-01-01

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.

78 FR 57445 - Charging Standard Administrative Fees for Nonprogram-Related Information

Science.gov (United States)

2013-09-18

... the Federal Register a schedule of standardized administrative fees we charge to recover the full cost... fee schedule is outdated and incongruent with the agency's current costs for this service. New... new standard fee on our most recent cost calculations for supplying this information and the standard...

Use of the Internet as a resource of health information by patients: A clinic-based study in the Indian population

Directory of Open Access Journals (Sweden)

Akerkar Shashank

2005-01-01

Full Text Available Background: There is abundant literature documenting that the Internet is fast changing the way patients access health-related information, learn about their illnesses, and make healthcare- related decisions. However, there is hardly any data regarding Indian patients accessing health-related information available on the Internet. Aims: To determine patients′ use of the Internet as a medical information resource and to determine their experience, their perceptions of the quality and reliability of the information available. Setting: The study was carried out in the outpatient clinic of an urban, tertiary care private sector hospital in November 2004. Material and Methods : Our survey instrument consisted of an anonymous single-page questionnaire. Eight hundred and eighty consecutive adults aged 18-70 years, attending the general outpatient clinic of a tertiary care private hospital completed the questionnaire. Results: Two hundred and eighty-one (32% patients acknowledged surfing the Internet, while 75% (212/281 of them acknowledged that they accessed health-related information. Amongst those who accessed the Internet, 130 (61% found the information on the net to be of average quality. Almost all patients (211/212 felt that the information served the purpose and 95% (201/212 also found also found it to be reliable. Only 7% (21/281 patients were aware of the presence of any quality standards pertaining to health information sites and none could name any accreditation standard. Conclusions: One in four patients attending the private set-up is using the Internet for health information. A majority of patients find the information on the net reliable and of good quality. Awareness about health information quality standards is a rarity.

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).

Science.gov (United States)

Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

2015-10-01

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.

'Trial Exegesis': Methods for Synthesizing Clinical and Patient Reported Outcome (PRO Data in Trials to Inform Clinical Practice. A Systematic Review.

Directory of Open Access Journals (Sweden)

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

Information disclosure in clinical informed consent: “reasonable” patient’s perception of norm in high-context communication culture

Science.gov (United States)

2014-01-01

Background 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. Methods 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. Results 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 disclosure of procedure’s name) to 13.9% (lead practitioner’s training place), ranking scores were worse for all items compared to norm perception (p 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. PMID:24406055

Clinical information in drug package inserts in India

Directory of Open Access Journals (Sweden)

Shivkar Y

2009-01-01

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

A comparative analysis of quality management standards for contract research organisations in clinical trials.

Science.gov (United States)

Murray, Elizabeth; McAdam, Rodney

2007-01-01

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.

Standardized Patients Provide a Reliable Assessment of Athletic Training Students' Clinical Skills

Science.gov (United States)

Armstrong, Kirk J.; Jarriel, Amanda J.

2016-01-01

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…

[The informed consent in international clinical trials including developing countries].

Science.gov (United States)

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

78 FR 54626 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal...

Science.gov (United States)

2013-09-05

...-01] Announcing Approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal... Commerce's approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal Identity... Information Processing Standards (FIPS). Homeland Security Presidential Directive (HSPD) 12, entitled ``Policy...

Establishment of quality assessment standard for mammographic equipment: evaluation of phantom and clinical images

International Nuclear Information System (INIS)

Lee, Sung Hoon; Choe, Yeon Hyeon; Chung, Soo Young

2005-01-01

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

Modelling the ICE standard with a formal language for information commerce

NARCIS (Netherlands)

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

Perspectives on Clinical Informatics: Integrating Large-Scale Clinical, Genomic, and Health Information for Clinical Care

Directory of Open Access Journals (Sweden)

In Young Choi

2013-12-01

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.

Open Architecture Standards and Information Systems (OASIS II ...

International Development Research Centre (IDRC) Digital Library (Canada)

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 ...

The need for European professional standards and the challenges facing clinical microbiology.

Science.gov (United States)

Humphreys, H; Nagy, E; Kahlmeter, G; Ruijs, G J H M

2010-06-01

Microorganisms spread across national boundaries and the professional activities of clinical (medical) microbiologists are critical in minimising their impact. Clinical microbiologists participate in many activities, e.g. diagnosis, antibiotic therapy, and there is a need for a set of professional standards for Europe with a common curriculum, to build upon the current strengths of the specialty and to facilitate the free movement of specialists within the European Union. Such standards will also better highlight the important contribution of clinical microbiologists to healthcare. There is a move to larger centralised microbiology laboratories often located off-site from an acute hospital, driven by the concentration of resources, amalgamation of services, outsourcing of diagnostics, automation, an explosion in the range of staff competencies and accreditation. Large off-site centralised microbiology laboratories are often distant to the patient and may not facilitate the early detection of microbial spread. Ultimately, the needs of patients and the public are paramount in deciding on the future direction of clinical microbiology. Potential conflicts between integration on an acute hospital site and centralisation can be resolved by a common set of professional standards and a team-based approach that puts patients first.

Exploring the structure and organization of information within nursing clinical handovers.

Science.gov (United States)

Johnson, Maree; Jefferies, Diana; Nicholls, Daniel

2012-10-01

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.

A review of standardized patients in clinical education: Implications for speech-language pathology programs.

Science.gov (United States)

Hill, Anne E; Davidson, Bronwyn J; Theodoros, Deborah G

2010-06-01

The use of standardized patients has been reported as a viable addition to traditional models of professional practice education in medicine, nursing and allied health programs. Educational programs rely on the inclusion of work-integrated learning components in order to graduate competent practitioners. Allied health programs world-wide have reported increasing difficulty in attaining sufficient traditional placements for students within the workplace. In response to this, allied health professionals are challenged to be innovative and problem-solving in the development and maintenance of clinical education placements and to consider potential alternative learning opportunities for students. Whilst there is a bank of literature describing the use of standardized patients in medicine and nursing, reports of its use in speech-language pathology clinical education are limited. Therefore, this paper aims to (1) provide a review of literature reporting on the use of standardized patients within medical and allied health professions with particular reference to use in speech-language pathology, (2) discuss methodological and practical issues involved in establishing and maintaining a standardized patient program and (3) identify future directions for research and clinical programs using standardized patients to build foundation clinical skills such as communication, interpersonal interaction and interviewing.

Information on blinding in registered records of clinical trials

Directory of Open Access Journals (Sweden)

Viergever Roderik F

2012-11-01

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.

CLAIM (CLinical Accounting InforMation)--an XML-based data exchange standard for connecting electronic medical record systems to patient accounting systems.

Science.gov (United States)

Guo, Jinqiu; Takada, Akira; Tanaka, Koji; Sato, Junzo; Suzuki, Muneou; Takahashi, Kiwamu; Daimon, Hiroyuki; Suzuki, Toshiaki; Nakashima, Yusei; Araki, Kenji; Yoshihara, Hiroyuki

2005-08-01

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.

Reconciling disparate information in continuity of care documents: Piloting a system to consolidate structured clinical documents.

Science.gov (United States)

Hosseini, Masoud; Jones, Josette; Faiola, Anthony; Vreeman, Daniel J; Wu, Huanmei; Dixon, Brian E

2017-10-01

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.

Executive overview and introduction to the SMAP information system life-cycle and documentation standards

Science.gov (United States)

1989-01-01

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.

[A web-based integrated clinical database for laryngeal cancer].

Science.gov (United States)

E, Qimin; Liu, Jialin; Li, Yong; Liang, Chuanyu

2014-08-01

To establish an integrated database for laryngeal cancer, and to provide an information platform for laryngeal cancer in clinical and fundamental researches. This database also meet the needs of clinical and scientific use. Under the guidance of clinical expert, we have constructed a web-based integrated clinical database for laryngeal carcinoma on the basis of clinical data standards, Apache+PHP+MySQL technology, laryngeal cancer specialist characteristics and tumor genetic information. A Web-based integrated clinical database for laryngeal carcinoma had been developed. This database had a user-friendly interface and the data could be entered and queried conveniently. In addition, this system utilized the clinical data standards and exchanged information with existing electronic medical records system to avoid the Information Silo. Furthermore, the forms of database was integrated with laryngeal cancer specialist characteristics and tumor genetic information. The Web-based integrated clinical database for laryngeal carcinoma has comprehensive specialist information, strong expandability, high feasibility of technique and conforms to the clinical characteristics of laryngeal cancer specialties. Using the clinical data standards and structured handling clinical data, the database can be able to meet the needs of scientific research better and facilitate information exchange, and the information collected and input about the tumor sufferers are very informative. In addition, the user can utilize the Internet to realize the convenient, swift visit and manipulation on the database.

Acceptance Factors Influencing Adoption of National Institute of Standards and Technology Information Security Standards: A Quantitative Study

Science.gov (United States)

Kiriakou, Charles M.

2012-01-01

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…

Patient representatives? views on patient information in clinical cancer trials

OpenAIRE

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-01-01

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 leaflet...

Readability of informed consent forms in clinical trials conducted in a skin research center

Science.gov (United States)

Samadi, Aniseh; Asghari, Fariba

2016-01-01

Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

Patient representatives' views on patient information in clinical cancer trials

DEFF Research Database (Denmark)

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-01-01

of future simplified and more attractive informed consent forms. CONCLUSIONS: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language......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...

Information and Communication Technology (ICT) Standards and Guidelines. Final rule.

Science.gov (United States)

2017-01-18

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.

Management plan documentation standard and Data Item Descriptions (DID). Volume of the information system life-cycle and documentation standards, volume 2

Science.gov (United States)

Callender, E. David; Steinbacher, Jody

1989-01-01

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.

"There are too many, but never enough": qualitative case study investigating routine coding of clinical information in depression.

Science.gov (United States)

Cresswell, Kathrin; Morrison, Zoe; Kalra, Dipak; Sheikh, Aziz

2012-01-01

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.

Detailed clinical models: a review.

Science.gov (United States)

Goossen, William; Goossen-Baremans, Anneke; van der Zel, Michael

2010-12-01

Due to the increasing use of electronic patient records and other health care information technology, we see an increase in requests to utilize these data. A highly level of standardization is required during the gathering of these data in the clinical context in order to use it for analyses. Detailed Clinical Models (DCM) have been created toward this purpose and several initiatives have been implemented in various parts of the world to create standardized models. This paper presents a review of DCM. Two types of analyses are presented; one comparing DCM against health care information architectures and a second bottom up approach from concept analysis to representation. In addition core parts of the draft ISO standard 13972 on DCM are used such as clinician involvement, data element specification, modeling, meta information, and repository and governance. SIX INITIATIVES WERE SELECTED: Intermountain Healthcare, 13606/OpenEHR Archetypes, Clinical Templates, Clinical Contents Models, Health Level 7 templates, and Dutch Detailed Clinical Models. Each model selected was reviewed for their overall development, involvement of clinicians, use of data types, code bindings, expressing semantics, modeling, meta information, use of repository and governance. Using both a top down and bottom up approach to comparison reveals many commonalties and differences between initiatives. Important differences include the use of or lack of a reference model and expressiveness of models. Applying clinical data element standards facilitates the use of conceptual DCM models in different technical representations.

Association of Informal Clinical Integration of Physicians With Cardiac Surgery Payments.

Science.gov (United States)

Funk, Russell J; Owen-Smith, Jason; Kaufman, Samuel A; Nallamothu, Brahmajee K; Hollingsworth, John M

2018-05-01

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

Neurorestorative clinical application standards for the culture and quality control of olfactory ensheathing cells

Directory of Open Access Journals (Sweden)

Xiao J

2017-09-01

Full Text Available Juan Xiao,1,2 Lin Chen,3 Gengsheng Mao,1 Wenyong Gao,1,2 Ming Lu,4 Xijing He,5 Hongyun Huang1,2 On behalf of the Neurorestoratology Professional Committee of Chinese Medical Doctors Association (Chinese Association of Neurorestoratology 1Institute of Neurorestoratology, The General Hospital of Chinese People’s Armed Police Forces, Beijing, People’s Republic of China; 2Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, People’s Republic of China; 3Department of Neurosurgery, Tsinghua University Yuquan Hospital, Beijing, People’s Republic of China; 4Department of Neurosurgery, 163 Hospital of PLA (Second Affiliated Hospital of Hunan Normal University, Changsha, Hunan Province, People’s Republic of China; 5Department of Orthopedics, Second Affiliated Hospital of Xi’an Jiaotong University, Xian, Shanxi Provine, People’s Republic of China Abstract: Olfactory ensheathing cells (OECs are a novel type of glial cell that can perform and promote many neurorestorative processes in vivo after transplant. To date, dozens of preclinical and clinical studies have confirmed that OECs have unique restoring effects in animal models and human subjects with neurological degeneration or damage, such as spinal cord injury, stroke, cerebral palsy, traumatic brain injury, and motor neuron disease (amyotrophic lateral sclerosis. To ensure the safety and effectiveness of clinical applications utilizing this type of cell, it is important to standardize cell-culture and quality-control processes. Based on a comprehensive review of published clinical studies, as well as existing methods of OEC culture and quality control currently utilized by hospitals and biomedical enterprises, the Chinese Association of Neurorestoratology has developed a set of standards for the culture and quality control of olfactory ensheathing cells for use in clinical applications. These guidelines include standardized training and management procedures for

Modelling the ICE standard with a formal language for information commerce

OpenAIRE

Wombacher, A.; Aberer, K.

2001-01-01

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 processes. We introduce a language that is specifically designed for information commerce. It can be directly used for the implementation of the processes and communication required in information comme...

National Mesothelioma Virtual Bank: A standard based biospecimen and clinical data resource to enhance translational research

Directory of Open Access Journals (Sweden)

Valdivieso Federico A

2008-08-01

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

Formalize clinical processes into electronic health information systems: Modelling a screening service for diabetic retinopathy.

Science.gov (United States)

Eguzkiza, Aitor; Trigo, Jesús Daniel; Martínez-Espronceda, Miguel; Serrano, Luis; Andonegui, José

2015-08-01

Most healthcare services use information and communication technologies to reduce and redistribute the workload associated with follow-up of chronic conditions. However, the lack of normalization of the information handled in and exchanged between such services hinders the scalability and extendibility. The use of medical standards for modelling and exchanging information, especially dual-model based approaches, can enhance the features of screening services. Hence, the approach of this paper is twofold. First, this article presents a generic methodology to model patient-centered clinical processes. Second, a proof of concept of the proposed methodology was conducted within the diabetic retinopathy (DR) screening service of the Health Service of Navarre (Spain) in compliance with a specific dual-model norm (openEHR). As a result, a set of elements required for deploying a model-driven DR screening service has been established, namely: clinical concepts, archetypes, termsets, templates, guideline definition rules, and user interface definitions. This model fosters reusability, because those elements are available to be downloaded and integrated in any healthcare service, and interoperability, since from then on such services can share information seamlessly. Copyright © 2015 Elsevier Inc. All rights reserved.

Development of a Conceptual Mapping Standard to Link Building and Geospatial Information

Directory of Open Access Journals (Sweden)

Taewook Kang

2018-04-01

Full Text Available This study introduces the BIM (building information modeling-GIS (geographic information system conceptual mapping (B2GM standard ISO N19166 and proposes a mapping mechanism. In addition, the major issues concerning BIM-GIS integration, and the considerations that it requires, are discussed. The B2GM is currently being standardized by the spatial-information international standardization organization TC211. Previous studies on BIM-GIS integration seem to focus on the integration of different types of model schemas and on the implementation of service interfaces. B2GM concerns the clear definition of the conditions and methods for mapping the object information required from the user’s use-case viewpoint for city-scale mapping. The benefits of the B2GM approach are that the user is able directly control the BIM-GIS linkage and integration process in order to acquire the necessary objection information. This can reveal cases of possibly unclear BIM-GIS integration outside the black box in an explicit and standard way, so that the user can distinctively predict the final output obtainable from the BIM-GIS integration. This study examined B2GM in terms of its development background, components, and several utilization examples, as well as the levels and considerations of the integration of different BIM-GIS models.

Clinical Simulation and Workflow by use of two Clinical Information Systems, the Electronic Health Record and Digital Dictation

DEFF Research Database (Denmark)

Schou Jensen, Iben; Koldby, Sven

2013-01-01

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......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...

Competence Requirements of ISO/IEC Standards for Information Security Professionals

Directory of Open Access Journals (Sweden)

Natalia G. Miloslavskaya

2017-11-01

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.

Opacity of financial information, adoption of international standards and legal origins

Directory of Open Access Journals (Sweden)

Renata Turola Takamatsu

2017-10-01

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.

Quality assurance in ultrasound screening for hepatocellular carcinoma using a standardized phantom and standard clinical images: a 3-year national investigation in Korea.

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Choi, Joon-Il; Jung, Seung Eun; Kim, Pyo Nyun; Cha, Sang Hoon; Jun, Jae Kwan; Lee, Hoo-Yeon; Park, Eun-Cheol

2014-06-01

The purpose of this study was to investigate the quality of ultrasound (US) imaging for hepatocellular carcinoma screening. The investigation was performed at all medical institutes participating in the National Cancer Screening Program in Korea. For assessment of personnel, we inquired who was performing the US screenings. For phantom image evaluation, the dead zone, vertical and horizontal measurements, axial and lateral resolution, sensitivity, and gray scale/dynamic range were evaluated. For clinical image evaluation, US images of patients were evaluated in terms of the standard images, technical information, overall image quality, appropriateness of depth, foci, annotations, and the presence of any artifacts. Failure rates for phantom and clinical image evaluations at general hospitals, smaller hospitals, and private clinics were 20.9%, 24.5%, 24.1% and 5.5%, and 14.8% and 9.5%, respectively. No statistically significant difference was observed in the failure rates for the phantom images among groups of different years of manufacture. For the clinical image evaluation, the results of radiologists were significantly better than those of other professional groups (P = .0001 and .0004 versus nonradiology physicians and nonphysicians, respectively). The failure rate was also higher when the storage format was analog versus digital (P quality of the clinical images obtained by radiologists was the best. © 2014 by the American Institute of Ultrasound in Medicine.

Development of a clinical data warehouse from an intensive care clinical information system.

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de Mul, Marleen; Alons, Peter; van der Velde, Peter; Konings, Ilse; Bakker, Jan; Hazelzet, Jan

2012-01-01

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.

Evaluation of the clinical process in a critical care information system using the Lean method: a case study

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Yusof Maryati Mohd

2012-12-01

Full Text Available Abstract Background There are numerous applications for Health Information Systems (HIS that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS, known as IntelliVue Clinical Information Portfolio (ICIP, and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy.

Patient representatives' views on patient information in clinical cancer trials.

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Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-02-01

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. Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Two major themes emerged: emotional responses and cognitive 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 of future simplified and more attractive informed consent forms. The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

MedTime: a temporal information extraction system for clinical narratives.

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Lin, Yu-Kai; Chen, Hsinchun; Brown, Randall A

2013-12-01

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.

Public information about clinical trials and research.

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Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

2003-01-01

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.

77 FR 21538 - Announcing DRAFT Revisions to Federal Information Processing Standard (FIPS) 186-3, Digital...

Science.gov (United States)

2012-04-10

...-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...

78 FR 39001 - 30-Day Notice of Proposed Information Collection: Uniform Physical Standards and Physical...

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2013-06-28

... 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...

Open Source, Open Standards, and Health Care Information Systems

Science.gov (United States)

2011-01-01

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

Using video-taped examples of standardized patient to teach medical students taking informed consent

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SHIRIN HABIBI KHORASANI

2015-04-01

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.

Comparison of anthropometry with photogrammetry based on a standardized clinical photographic technique using a cephalostat and chair.

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Han, Kihwan; Kwon, Hyuk Joon; Choi, Tae Hyun; Kim, Jun Hyung; Son, Daegu

2010-03-01

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.

Standards for the culture and quality control of umbilical cord mesenchymal stromal cells for neurorestorative clinical application (2017

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Ao Q

2017-12-01

Full Text Available Qiang Ao,1,* Juan Xiao,2,3,* Yanqiu Yu,4 Gengsheng Mao,2 Qingyan Zou,5 Wenyong Gao,2,3 Hongyun Huang2,3 On behalf of Neurorestoratology Professional Committee of Chinese Medical Doctor Association (Chinese Association of Neurorestoratology 1Department of Tissue Engineering, China Medical University, Shen Yang, 2Institute of Neurorestoratology, General Hospital of Armed Police Forces, Beijing, 3Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, 4Department of Pathophysiology, China Medical University, Shen Yang, 5Guangdong 999 Brain Hospital, Guangzhou, People’s Republic of China *These authors contributed equally to this work Abstract: Formulating common standards for the culture and quality control of umbilical cord mesenchymal stromal cells (MSCs is crucial for the standardization of clinical neurorestorative therapy. But to date, there have been no standardized guidelines for the culture and quality control of MSCs in neurorestorative clinical application. Based on a relatively comprehensive review of published clinical studies as well as the existing methods of MSC culture and quality control, the Chinese Association of Neurorestoratology has developed standards for the culture and quality control of umbilical cord MSCs which possess the potential in neurorestorative clinical application. These guidelines include standardized training and management procedures for laboratory operators; standardized use and management of materials and equipment; standardized collection, culture and proliferation of umbilical cord MSCs; standardized management for cell preservation, transport and related safeguard measures; as well as standardization of a clean environment, routine maintenance and related tests and examinations and so on. These guidelines represent the minimum required standards for the culture and quality control of umbilical cord MSCs for potential use in current neurorestorative clinical therapy, and will be further

ICT-Enabled Time-Critical Clinical Practices: Examining the Affordances of an Information Processing Solution

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Leonard Hoon

2015-11-01

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.

How information systems should support the information needs of general dentists in clinical settings: suggestions from a qualitative study

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Wali Teena

2010-02-01

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

APPROACHES TO STANDARDIZATION OF STUDENTS INFORMATION AND COMMUNICATION COMPETENCE DEVELOPMENT: THE POLISH EXPERIENCE

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Mariya P. Leshchenko

2014-09-01

Full Text Available In the article foreign, in particular, the Polish experience of diagnostic of students information and communication competencies is characterized. Foreign scientists focuse their modern searches on identifying students skills of using the Internet. Standards defined by Polish researchers are multifunctional and enable the determination of the cognitive, appraisal, creative and social students skills to function in the network. Structure of seven standards (literate and successful information search, critical evaluation of information, creation, transformation and presentation of information content, legal principles of creation and distribution of information content, empathy and imagemaking, security and privacy; participation in the online communities, their components and related parameters are characterized. General results of Polish scientists researches are presented.

MedEx: a medication information extraction system for clinical narratives

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Stenner, Shane P; Doan, Son; Johnson, Kevin B; Waitman, Lemuel R; Denny, Joshua C

2010-01-01

Medication information is one of the most important types of clinical data in electronic medical records. It is critical for healthcare safety and quality, as well as for clinical research that uses electronic medical record data. However, medication data are often recorded in clinical notes as free-text. As such, they are not accessible to other computerized applications that rely on coded data. We describe a new natural language processing system (MedEx), which extracts medication information from clinical notes. MedEx was initially developed using discharge summaries. An evaluation using a data set of 50 discharge summaries showed it performed well on identifying not only drug names (F-measure 93.2%), but also signature information, such as strength, route, and frequency, with F-measures of 94.5%, 93.9%, and 96.0% respectively. We then applied MedEx unchanged to outpatient clinic visit notes. It performed similarly with F-measures over 90% on a set of 25 clinic visit notes. PMID:20064797

Providing support to nursing students in the clinical environment: a nursing standard requirement.

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Anderson, Carina; Moxham, Lorna; Broadbent, Marc

2016-10-01

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.

The Standardization Method of Address Information for POIs from Internet Based on Positional Relation

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WANG Yong

2016-05-01

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.

Clinical and Para Clinical Information Needs of Infertility Electronic Health Records in Iran: A Delphi Study.

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Farzandipour, Mehrdad; Jeddi, Fateme Rangraz; Gilasi, Hamid Reza; Shirzadi, Diana

2017-09-01

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.

Informal sources of supervision in clinical training.

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Farber, Barry A; Hazanov, Valery

2014-11-01

Although formal, assigned supervision is a potent source of learning and guidance for psychotherapy trainees, many beginning psychotherapists use other, informal sources of supervision or consultation for advice and support. Results of an online survey of beginning trainees (N = 146) indicate that other than their formally assigned supervisor, trainees most often consult with colleagues in their program, their own psychotherapist, and their significant other; that they're most likely to seek these other sources of help when they're feeling stuck or feel they've made a clinical mistake; that they do so because they need extra reassurance and suggestions; that they feel the advice given from these sources is helpful; and that they don't especially regret sharing this information. Several case examples are used to illustrate these points. Discussing clinical material with informal sources is, apparently, a great deal more common than typically acknowledged, and as such, has implications for training programs (including discussions of ethics) and formal supervision. © 2014 Wiley Periodicals, Inc.

Performance of informative priors skeptical of large treatment effects in clinical trials: A simulation study.

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Pedroza, Claudia; Han, Weilu; Thanh Truong, Van Thi; Green, Charles; Tyson, Jon E

2018-01-01

One of the main advantages of Bayesian analyses of clinical trials is their ability to formally incorporate skepticism about large treatment effects through the use of informative priors. We conducted a simulation study to assess the performance of informative normal, Student- t, and beta distributions in estimating relative risk (RR) or odds ratio (OR) for binary outcomes. Simulation scenarios varied the prior standard deviation (SD; level of skepticism of large treatment effects), outcome rate in the control group, true treatment effect, and sample size. We compared the priors with regards to bias, mean squared error (MSE), and coverage of 95% credible intervals. Simulation results show that the prior SD influenced the posterior to a greater degree than the particular distributional form of the prior. For RR, priors with a 95% interval of 0.50-2.0 performed well in terms of bias, MSE, and coverage under most scenarios. For OR, priors with a wider 95% interval of 0.23-4.35 had good performance. We recommend the use of informative priors that exclude implausibly large treatment effects in analyses of clinical trials, particularly for major outcomes such as mortality.

Standardization versus customization of glucose reporting.

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Rodbard, David

2013-05-01

Bergenstal et al. (Diabetes Technol Ther 2013;15:198-211) described an important approach toward standardization of reporting and analysis of continuous glucose monitoring and self-monitoring of blood glucose (SMBG) data. The ambulatory glucose profile (AGP), a composite display of glucose by time of day that superimposes data from multiple days, is perhaps the most informative and useful of the many graphical approaches to display glucose data. However, the AGP has limitations; some variations are desirable and useful. Synchronization with respect to meals, traditionally used in glucose profiles for SMBG data, can improve characterization of postprandial glucose excursions. Several other types of graphical display are available, and recently developed ones can augment the information provided by the AGP. There is a need to standardize the parameters describing glycemic variability and cross-validate the available computer programs that calculate glycemic variability. Clinical decision support software can identify and prioritize clinical problems, make recommendations for modifications of therapy, and explain its justification for those recommendations. The goal of standardization is challenging in view of the diversity of clinical situations and of computing and display platforms and software. Standardization is desirable but must be done in a manner that permits flexibility and fosters innovation.

Common data model for natural language processing based on two existing standard information models: CDA+GrAF.

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Meystre, Stéphane M; Lee, Sanghoon; Jung, Chai Young; Chevrier, Raphaël D

2012-08-01

An increasing need for collaboration and resources sharing in the Natural Language Processing (NLP) research and development community motivates efforts to create and share a common data model and a common terminology for all information annotated and extracted from clinical text. We have combined two existing standards: the HL7 Clinical Document Architecture (CDA), and the ISO Graph Annotation Format (GrAF; in development), to develop such a data model entitled "CDA+GrAF". We experimented with several methods to combine these existing standards, and eventually selected a method wrapping separate CDA and GrAF parts in a common standoff annotation (i.e., separate from the annotated text) XML document. Two use cases, clinical document sections, and the 2010 i2b2/VA NLP Challenge (i.e., problems, tests, and treatments, with their assertions and relations), were used to create examples of such standoff annotation documents, and were successfully validated with the XML schemata provided with both standards. We developed a tool to automatically translate annotation documents from the 2010 i2b2/VA NLP Challenge format to GrAF, and automatically generated 50 annotation documents using this tool, all successfully validated. Finally, we adapted the XSL stylesheet provided with HL7 CDA to allow viewing annotation XML documents in a web browser, and plan to adapt existing tools for translating annotation documents between CDA+GrAF and the UIMA and GATE frameworks. This common data model may ease directly comparing NLP tools and applications, combining their output, transforming and "translating" annotations between different NLP applications, and eventually "plug-and-play" of different modules in NLP applications. Copyright © 2011 Elsevier Inc. All rights reserved.

Information Engineering and Workflow Design in a Clinical Decision Support System for Colorectal Cancer Screening in Iran.

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Maserat, Elham; Seied Farajollah, Seiede Sedigheh; Safdari, Reza; Ghazisaeedi, Marjan; Aghdaei, Hamid Asadzadeh; Zali, Mohammad Reza

2015-01-01

Colorectal cancer is a major cause of morbidity and mortality throughout the world. Colorectal cancer screening is an optimal way for reducing of morbidity and mortality and a clinical decision support system (CDSS) plays an important role in predicting success of screening processes. DSS is a computer-based information system that improves the delivery of preventive care services. The aim of this article was to detail engineering of information requirements and work flow design of CDSS for a colorectal cancer screening program. In the first stage a screening minimum data set was determined. Developed and developing countries were analyzed for identifying this data set. Then information deficiencies and gaps were determined by check list. The second stage was a qualitative survey with a semi-structured interview as the study tool. A total of 15 users and stakeholders' perspectives about workflow of CDSS were studied. Finally workflow of DSS of control program was designed by standard clinical practice guidelines and perspectives. Screening minimum data set of national colorectal cancer screening program was defined in five sections, including colonoscopy data set, surgery, pathology, genetics and pedigree data set. Deficiencies and information gaps were analyzed. Then we designed a work process standard of screening. Finally workflow of DSS and entry stage were determined. A CDSS facilitates complex decision making for screening and has key roles in designing optimal interactions between colonoscopy, pathology and laboratory departments. Also workflow analysis is useful to identify data reconciliation strategies to address documentation gaps. Following recommendations of CDSS should improve quality of colorectal cancer screening.

Using video-taped examples of standardized patient to teach medical students taking informed consent.

Science.gov (United States)

Habibi Khorasani, Shirin; Ebrahimi, Sedigheh

2015-04-01

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 intaking informed consent from patients. 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 coursebefore 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 issuesthrough the scenario based ethical examination before and after each training. Scenarios were related to the topics ofinformed consent. Data were analyzed by SPSS 14 software using descriptive statistics and anovatest.P-Value less than 0.05 was considered as significant. The mean scores results of A2, A1and B groupwere found to be7.21 , 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 (plecture-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 methodsof teaching should be used together for better result.

“There Are Too Many, but Never Enough": Qualitative Case Study Investigating Routine Coding of Clinical Information in Depression

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Cresswell, Kathrin; Morrison, Zoe; Sheikh, Aziz; Kalra, Dipak

2012-01-01

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

Health Management Information System in Private Clinics in Ilorin ...

African Journals Online (AJOL)

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 ...

Developing the Role of a Health Information Professional in a Clinical Research Setting

Directory of Open Access Journals (Sweden)

Helen M. Seeley

2010-06-01

Full Text Available Objective ‐ This paper examines the role of a health information professional in a large multidisciplinary project to improve services for head injury.Methods ‐ An action research approach was taken, with the information professional acting as co‐ordinator. Change management processes were guided by theory and evidence. The health information professional was responsible for an ongoing literature review on knowledge management (clinical and political issues, data collection and analysis (from patient records, collating and comparing data (to help develop standards, and devising appropriate dissemination strategies.Results ‐ Important elements of the health information management role proved to be 1 co‐ordination; 2 setting up mechanisms for collaborative learning through information sharing; and 3 using the theoretical frameworks (identified from the literature review to help guide implementation. The role that emerged here has some similarities to the informationist role that stresses domain knowledge, continuous learning and working in context (embedding. This project also emphasised the importance of co‐ordination, and the ability to work across traditional library information analysis (research literature discovery and appraisal and information analysis of patient data sets (the information management role.Conclusion ‐ Experience with this project indicates that health information professionals will need to be prepared to work with patient record data and synthesis of that data, design systems to co‐ordinate patient data collection, as well as critically appraise external evidence.

Core Standards of the EUBIROD Project. Defining a European Diabetes Data Dictionary for Clinical Audit and Healthcare Delivery.

Science.gov (United States)

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

2016-01-01

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.

Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

Science.gov (United States)

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

2013-01-01

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

Suboptimal compliance with blood culture standards at a district

African Journals Online (AJOL)

The Clinical and Laboratory Standards. Institute (CLSI)'s ... reviewing clinical and laboratory data and by a clinician questionnaire. Results. ... the laboratory information system (LIS). ..... management of severe sepsis and septic shock: 2012.

GCP compliance and readability of informed consent forms from an emerging hub for clinical trials

Directory of Open Access Journals (Sweden)

Satish Chandrasekhar Nair

2015-01-01

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.

The Performance of Standardized Patients in Portraying Clinical Scenarios in Speech-Language Therapy

Science.gov (United States)

Hill, Anne E.; Davidson, Bronwyn J.; Theodoros, Deborah G.

2013-01-01

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…

Evaluating the Quality of Website Information of Private-Practice Clinics Offering Cell Therapies in Japan.

Science.gov (United States)

Kashihara, Hidenori; Nakayama, Takeo; Hatta, Taichi; Takahashi, Naomi; Fujita, Misao

2016-05-24

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

Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop.

Science.gov (United States)

Jabs, Douglas A; Nussenblatt, Robert B; Rosenbaum, James T

2005-09-01

To begin a process of standardizing the methods for reporting clinical data in the field of uveitis. Consensus workshop. Members of an international working group were surveyed about diagnostic terminology, inflammation grading schema, and outcome measures, and the results used to develop a series of proposals to better standardize the use of these entities. Small groups employed nominal group techniques to achieve consensus on several of these issues. The group affirmed that an anatomic classification of uveitis should be used as a framework for subsequent work on diagnostic criteria for specific uveitic syndromes, and that the classification of uveitis entities should be on the basis of the location of the inflammation and not on the presence of structural complications. Issues regarding the use of the terms "intermediate uveitis," "pars planitis," "panuveitis," and descriptors of the onset and course of the uveitis were addressed. The following were adopted: standardized grading schema for anterior chamber cells, anterior chamber flare, and for vitreous haze; standardized methods of recording structural complications of uveitis; standardized definitions of outcomes, including "inactive" inflammation, "improvement'; and "worsening" of the inflammation, and "corticosteroid sparing," and standardized guidelines for reporting visual acuity outcomes. A process of standardizing the approach to reporting clinical data in uveitis research has begun, and several terms have been standardized.

Clinical information modeling processes for semantic interoperability of electronic health records: systematic review and inductive analysis.

Science.gov (United States)

Moreno-Conde, Alberto; Moner, David; Cruz, Wellington Dimas da; Santos, Marcelo R; Maldonado, José Alberto; Robles, Montserrat; Kalra, Dipak

2015-07-01

This systematic review aims to identify and compare the existing processes and methodologies that have been published in the literature for defining clinical information models (CIMs) that support the semantic interoperability of electronic health record (EHR) systems. Following the preferred reporting items for systematic reviews and meta-analyses systematic review methodology, the authors reviewed published papers between 2000 and 2013 that covered that semantic interoperability of EHRs, found by searching the PubMed, IEEE Xplore, and ScienceDirect databases. Additionally, after selection of a final group of articles, an inductive content analysis was done to summarize the steps and methodologies followed in order to build CIMs described in those articles. Three hundred and seventy-eight articles were screened and thirty six were selected for full review. The articles selected for full review were analyzed to extract relevant information for the analysis and characterized according to the steps the authors had followed for clinical information modeling. Most of the reviewed papers lack a detailed description of the modeling methodologies used to create CIMs. A representative example is the lack of description related to the definition of terminology bindings and the publication of the generated models. However, this systematic review confirms that most clinical information modeling activities follow very similar steps for the definition of CIMs. Having a robust and shared methodology could improve their correctness, reliability, and quality. Independently of implementation technologies and standards, it is possible to find common patterns in methods for developing CIMs, suggesting the viability of defining a unified good practice methodology to be used by any clinical information modeler. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

International Financial Reporting Standards Convergence and Quality of Accounting Information: Evidence from Indonesia

OpenAIRE

Yusrina, Hasyyati; Mukhtaruddin, Mukhtaruddin; Fuadah, Luk Luk; Sulong, Zunaidah

2017-01-01

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...

75 FR 62686 - Health Information Technology: Revisions to Initial Set of Standards, Implementation...

Science.gov (United States)

2010-10-13

... Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and... Health Information Technology (ONC), Department of Health and Human Services. ACTION: Interim final rule... Coordinator for Health Information Technology, Attention: Steven Posnack, Hubert H. Humphrey Building, Suite...

78 FR 76627 - Health Information Technology Standards Committee Advisory Meeting: Notice of Meeting

Science.gov (United States)

2013-12-18

... 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...

Effect of clinical information in brain CT scan interpretation : a blinded double crossover study

International Nuclear Information System (INIS)

Zhianpour, M.; Janghorbani, M.

2004-01-01

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

Web 2.0-based crowdsourcing for high-quality gold standard development in clinical natural language processing.

Science.gov (United States)

Zhai, Haijun; Lingren, Todd; Deleger, Louise; Li, Qi; Kaiser, Megan; Stoutenborough, Laura; Solti, Imre

2013-04-02

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

What Information Does Your EHR Contain? Automatic Generation of a Clinical Metadata Warehouse (CMDW) to Support Identification and Data Access Within Distributed Clinical Research Networks.

Science.gov (United States)

Bruland, Philipp; Doods, Justin; Storck, Michael; Dugas, Martin

2017-01-01

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.

Information Systems Security Management: A Review and a Classification of the ISO Standards

Science.gov (United States)

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.

12 CFR Appendix B to Part 30 - Interagency Guidelines Establishing Information Security Standards

Science.gov (United States)

2010-01-01

... Processing, Feb. 9, 2000; OCC Bulletin 2001-47, “Third-Party Relationships Risk Management Principles,” Nov... Existing Authority C. Definitions II. Standards for Safeguarding Customer Information A. Information Security Program B. Objectives III. Development and Implementation of Customer Information Security Program...

Study on a Threat-Countermeasure Model Based on International Standard Information

Directory of Open Access Journals (Sweden)

Guillermo Horacio Ramirez Caceres

2008-12-01

Full Text Available Many international standards exist in the field of IT security. This research is based on the ISO/IEC 15408, 15446, 19791, 13335 and 17799 standards. In this paper, we propose a knowledge base comprising a threat countermeasure model based on international standards for identifying and specifying threats which affect IT environments. In addition, the proposed knowledge base system aims at fusing similar security control policies and objectives in order to create effective security guidelines for specific IT environments. As a result, a knowledge base of security objectives was developed on the basis of the relationships inside the standards as well as the relationships between different standards. In addition, a web application was developed which displays details about the most common threats to information systems, and for each threat presents a set of related security control policies from different international standards, including ISO/IEC 27002.

Influence of clinical information on the diagnostic validity of MRI in the detection of abacterial sacroiliitis; Einfluss klinischer Informationen auf die diagnostische Wertigkeit der MRT bei der Frage nach einer abakteriellen Sakroiliitis

Energy Technology Data Exchange (ETDEWEB)

Remplik, P.; Schukai, O.; Roemer, F.W.; Fischer, W.; Buecklein, W.; Mott, K.; Bohndorf, K. [Klinik fuer Diagnostische Radiologie und Neuroradiologie, Klinikum Augsburg (Germany); Schalm, J. [3. Medizinische Klinik, Funktionsbereich Rheumatologie, Klinikum Augsburg (Germany)

2005-06-01

Purpose: to evaluate the influence of clinical information on the diagnostic validity of MRI in the detection of abacterial sacroiliitis. Evaluation of sensitivities, specificities, negative (NPV) and positive predictive values (PPV) for MRI with and without clinical information in comparison to a prior defined standard. Materials and methods: the results of routine MRI reports of 65 patients with the clinical suspicion of abacterial sacroiliitis referred by rheumatologists for MR assessment of the sacroiliac joints were retrospectively reviewed. These results were compared to the results of a blinded reading of the same examinations performed without any clinical information. The MRI protocol included T1-SE, STIR and T1-SE contrast-enhanced sequences with fat saturation. All patients were followed for at least four years. The standard of reference was defined by an experienced rheumatologist and included baseline and follow-up data (clinical, laboratory and imaging). Abacterial sacroiliitis was diagnosed in 19 patients. Results: under routine clinical conditions, MRI revealed a sensitivity of 94.7% and specificity of 97.8%. A PPV of 94.7% and a NPV of 97.8% were achieved. Without clinical information, MRI revealed a sensitivity and specificity of 64 and 80%, and a PPV of 49% and a NPV of 86%, respectively. Conclusion: the additional knowledge of clinical information for the MR diagnosis of abacterial sacroiliitis increases its diagnostic value for the assessment of abacterial sacroiliitis. (orig.)

76 FR 43631 - Revision of the Materiality to Patentability Standard for the Duty To Disclose Information in...

Science.gov (United States)

2011-07-21

... 0651-AC58 Revision of the Materiality to Patentability Standard for the Duty To Disclose Information in... revise the standard for materiality for the duty to disclose information in patent applications and... revise the materiality standard for the duty to disclose to match the materiality standard, as defined in...

12 CFR Appendix F to Part 225 - Interagency Guidelines Establishing Information Security Standards

Science.gov (United States)

2010-01-01

... Relationships Risk Management Principles,” Nov. 1, 2001; FDIC FIL 68-99, Risk Assessment Tools and Practices for.... Standards for Safeguarding Customer Information A. Information Security Program B. Objectives III. Development and Implementation of Customer Information Security Program A. Involve the Board of Directors B...

75 FR 44589 - Health Information Technology: Initial Set of Standards, Implementation Specifications, and...

Science.gov (United States)

2010-07-28

... 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...

76 FR 1432 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee...

Science.gov (United States)

2011-01-10

... Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice of Meeting. This notice announces a... Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Standards...

75 FR 8954 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee...

Science.gov (United States)

2010-02-26

... Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National Coordinator for Health Information Technology, HHS ACTION: Notice of meeting. This notice announces a... Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Standards...

75 FR 70923 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee...

Science.gov (United States)

2010-11-19

... Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice of meeting. This notice announces a... Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Standards...

75 FR 29761 - Office of the National Coordinator for Health Information Technology: HIT Standards Committee...

Science.gov (United States)

2010-05-27

... Technology: HIT Standards Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice of meeting. This notice announces a... Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Standards...

76 FR 4354 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee...

Science.gov (United States)

2011-01-25

... Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice of meeting. This notice announces a... Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Standards...

Potential Ramifications of Common Core State Standards Adoption on Information Literacy

Directory of Open Access Journals (Sweden)

Jacob Paul Eubanks

2014-07-01

Full Text Available In the United States, the decline in jobs for high school educated workers and the proliferation of jobs for post-secondary educated workers is driving the development of the Common Core State Standards. The Common Core State Standards theoretically shift K-12 pedagogy towards ability development of critical and extended thinking skills, preparing high school graduates for college and career readiness. This literature review explores the reasoning behind the shift to the Common Core State Standards and asks questions regarding the potential ramifications their adoption might have on post-secondary information literacy instruction.

High-end clinical domain information systems for effective healthcare delivery.

Science.gov (United States)

Mangalampalli, Ashish; Rama, Chakravarthy; Muthiyalian, Raja; Jain, Ajeet K

2007-01-01

The Electronic Health Record (EHR) provides doctors with a quick, reliable, secure, real-time and user-friendly source of all relevant patient data. The latest information system technologies, such as Clinical Data Warehouses (CDW), Clinical Decision-Support (CDS) systems and data-mining techniques (Online Analytical Processing (OLAP) and Online Transactional Processing (OLTP)), are used to maintain and utilise patient data intelligently, based on the users' requirements. Moreover, clinical trial reports for new drug approvals are now being submitted electronically for faster and easier processing. Also, information systems are used in educating patients about the latest developments in medical science through the internet and specially configured kiosks in hospitals and clinics.

Moving Forward: A Discussion on the Revision of the ACRL Information Literacy Standards for Higher Education

Directory of Open Access Journals (Sweden)

Ellysa Stern Cahoy

2013-12-01

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.

Perception matters for clinical perfectionism and social anxiety.

Science.gov (United States)

Levinson, Cheri A; Rodebaugh, Thomas L; Shumaker, Erik A; Menatti, Andrew R; Weeks, Justin W; White, Emily K; Heimberg, Richard G; Warren, Cortney S; Blanco, Carlos; Schneier, Franklin; Liebowitz, Michael R

2015-01-01

Despite research documenting a relationship between social anxiety and perfectionism, very little research has examined the relationship between social anxiety and clinical perfectionism, defined as the combination of high personal standards and high maladaptive perfectionistic evaluative concern. In the current studies we examined whether clinical perfectionism predicted social anxiety in a large sample of undergraduates (N=602), in a clinical sample of participants diagnosed with social anxiety disorder (SAD; N=180), and by using a variance decomposition model of self- and informant-report of perfectionism (N=134). Using self-report, we found that an interaction of personal standards and evaluative concern predicted both social interaction anxiety and fear of scrutiny, but not in the theorized direction. Specifically, we found that self-report of low standards and high evaluative concern was associated with the highest levels of social anxiety, suggesting that when individuals with SAD hold low expectations for themselves combined with high concerns about evaluation, social anxiety symptoms may increase. Alternatively, when an informants' perspective was considered, and more consistent with the original theory, we found that the interaction of informant-only report of personal standards and shared-report (between both primary participant and informant) of concern over mistakes was associated with self-reported social anxiety, such that high concern over mistakes and high personal standards predicted the highest levels of social anxiety. Theoretical, clinical, and measurement implications for clinical perfectionism are discussed. Copyright © 2014 Elsevier Ltd. All rights reserved.

Informing Workers of Chemical Hazards: The OSHA Hazard Communication Standard.

Science.gov (United States)

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…

The System 80+ Standard Plant Information Management System

Energy Technology Data Exchange (ETDEWEB)

Turk, R.S.; Bryan, R.E. [ABB Combuions Engineering Nuclear Systems (United States)

1998-07-01

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)

The System 80+ Standard Plant Information Management System

International Nuclear Information System (INIS)

Turk, R.S.; Bryan, R.E.

1998-01-01

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)

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

International Nuclear Information System (INIS)

Jang, Sol Ah; Kim, Joo Yeon; Yoo, Ji Yup; Shin, Woo Ho; Park, Tai Jin; Song, Myung Jae

2015-01-01

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

Energy Technology Data Exchange (ETDEWEB)

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)

2015-02-15

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.

Effect of information literacy training course on information literacy skills of undergraduate students of Isfahan University of Medical Sciences based on ACRL standards.

Science.gov (United States)

Karimi, Zohreh; Ashrafi-Rizi, Hasan; Papi, Ahmad; Shahrzadi, Leila; Hassanzadeh, Akbar

2015-01-01

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

Automatic exchange of information: towards a new global standard of tax transparency

Directory of Open Access Journals (Sweden)

Miguel Eduardo Pecho Trigueros

2014-07-01

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.

A review of multidisciplinary clinical practice guidelines in suicide prevention: toward an emerging standard in suicide risk assessment and management, training and practice.

Science.gov (United States)

Bernert, Rebecca A; Hom, Melanie A; Roberts, Laura Weiss

2014-10-01

The current paper aims to: (1) examine clinical practice guidelines in suicide prevention across fields, organizations, and clinical specialties and (2) inform emerging standards in clinical practice, research, and training. The authors conducted a systematic literature review to identify clinical practice guidelines and resource documents in suicide prevention and risk management. The authors used PubMed, Google Scholar, and Google Search, and keywords included: clinical practice guideline, practice guideline, practice parameters, suicide, suicidality, suicidal behaviors, assessment, and management. To assess for commonalities, the authors reviewed guidelines and resource documents across 13 key content categories and assessed whether each document suggested validated assessment measures. The search generated 101 source documents, which included N = 10 clinical practice guidelines and N = 12 additional resource documents (e.g., non-formalized guidelines, tool-kits). All guidelines (100 %) provided detailed recommendations for the use of evidence-based risk factors and protective factors, 80 % provided brief (but not detailed) recommendations for the assessment of suicidal intent, and 70 % recommended risk management strategies. By comparison, only 30 % discussed standardization of risk-level categorizations and other content areas considered central to best practices in suicide prevention (e.g., restricting access to means, ethical considerations, confidentiality/legal issues, training, and postvention practices). Resource documents were largely consistent with these findings. Current guidelines address similar aspects of suicide risk assessment and management, but significant discrepancies exist. A lack of consensus was evident in recommendations across core competencies, which may be improved by increased standardization in practice and training. Additional resources appear useful for supplemental use.

A scheme for the audit of scientific and technological standards in clinical nuclear medicine

International Nuclear Information System (INIS)

Perkins, A.C.; Jarritt, P.H.

2002-01-01

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

Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial

Science.gov (United States)

Parkin, Patricia C; Willan, Andrew R; Schuh, Suzanne

2011-01-01

Objective To determine if rapid rather than standard intravenous rehydration results in improved hydration and clinical outcomes when administered to children with gastroenteritis. Design Single centre, two arm, parallel randomised pragmatic controlled trial. Blocked randomisation stratified by site. Participants, caregivers, outcome assessors, investigators, and statisticians were blinded to the treatment assignment. Setting Paediatric emergency department in a tertiary care centre in Toronto, Canada. Participants 226 children aged 3 months to 11 years; complete follow-up was obtained on 223 (99%). Eligible children were aged over 90 days, had a diagnosis of dehydration secondary to gastroenteritis, had not responded to oral rehydration, and had been prescribed intravenous rehydration. Children were excluded if they weighed less than 5 kg or more than 33 kg, required fluid restriction, had a suspected surgical condition, or had an insurmountable language barrier. Children were also excluded if they had a history of a chronic systemic disease, abdominal surgery, bilious or bloody vomit, hypotension, or hypoglycaemia or hyperglycaemia. Interventions Rapid (60 mL/kg) or standard (20 mL/kg) rehydration with 0.9% saline over an hour; subsequent fluids administered according to protocol. Main outcome measures Primary outcome: clinical rehydration, assessed with a validated scale, two hours after the start of treatment. Secondary outcomes: prolonged treatment, mean clinical dehydration scores over the four hour study period, time to discharge, repeat visits to emergency department, adequate oral intake, and physician’s comfort with discharge. Data from all randomised patients were included in an intention to treat analysis. Results 114 patients were randomised to rapid rehydration and 112 to standard. One child was withdrawn because of severe hyponatraemia at baseline. There was no evidence of a difference between the rapid and standard rehydration groups in the

[Changes in clinical standards and the need for adjusting legal standards of care from the point of view of civil law].

Science.gov (United States)

Rosenberger, Rainer

2007-01-01

The legal standard of medical care is laid down in Sect. 276 of the German Civil Code (principle of due diligence). It applies to both contractual and tortious liability and likewise to the treatment of patients insured under the statutory health insurance scheme and self-payers. The legal standard of care conforms to the clinical standards because medical liability means medical professional liability. Liability law does not distinguish between different standards of care in the treatment of patients insured under the statutory health insurance scheme on the one hand and privately insured patients on the other. Changes in clinical standards immediately affect liability law without the need for formal adaptation of the legal standard of care. Liability law cannot claim more diligence than that owed from a medical point of view. Legislative changes that result in a lowering of medical standards (reduction in the quality of treatment) will have to be accepted by liability law, even if these are regulations pertaining to Social Law (SGB V, Book 5 of the German Social Code). In this respect, the principle of legal unity applies. In consideration of this kind of changes the due diligence requirements for the treatment of patients insured under the statutory health insurance scheme and privately insured patients remain basically equal. If these changes lead to an increase of risk for the patient, the resulting liabilities are not to be attributed to the therapist. What remains to be seen is whether there will be an increased attempt to minimise risk by "additionally purchasing health care services".

Resource utilization after introduction of a standardized clinical assessment and management plan.

Science.gov (United States)

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

2010-01-01

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.

Informal Leadership in the Clinical Setting: Occupational Therapist Perspectives

Directory of Open Access Journals (Sweden)

Clark Patrick Heard

2018-04-01

Full Text Available Background: Leadership is vital to clinical, organizational, and professional success. This has compelled a high volume of research primarily related to formal leadership concepts. However, as organizations flatten, eliminate departmental structures, or decentralize leadership structures the relevance of informal leaders has markedly enhanced. Methods: Using a qualitative phenomenological methodology consistent with interpretative phenomenological analysis, this study examines the impact of informal leadership in the clinical setting for occupational therapists. Data was collected through the completion of semi-structured interviews with 10 peer-identified informal occupational therapy leaders in Ontario, Canada. Collected data was transcribed verbatim and coded for themes by multiple coders. Several methods were employed to support trustworthiness. Results: The results identify that informal leaders are collaborative, accessible, and considered the “go to” staff. They demonstrate professional competence knowledge, experience, and accountability and are inspirational and creative. Practically, informal leaders organically shape the practice environment while building strength and capacity among their peers. Conclusion: Recommendations for supporting informal leaders include acknowledgement of the role and its centrality, enabling informal leaders time to undertake the role, and supporting consideration of informal leadership concepts at the curriculum and professional level.

Development of clinical practice guidelines.

Science.gov (United States)

Hollon, Steven D; Areán, Patricia A; Craske, Michelle G; Crawford, Kermit A; Kivlahan, Daniel R; Magnavita, Jeffrey J; Ollendick, Thomas H; Sexton, Thomas L; Spring, Bonnie; Bufka, Lynn F; Galper, Daniel I; Kurtzman, Howard

2014-01-01

Clinical practice guidelines (CPGs) are intended to improve mental, behavioral, and physical health by promoting clinical practices that are based on the best available evidence. The American Psychological Association (APA) is committed to generating patient-focused CPGs that are scientifically sound, clinically useful, and informative for psychologists, other health professionals, training programs, policy makers, and the public. The Institute of Medicine (IOM) 2011 standards for generating CPGs represent current best practices in the field. These standards involve multidisciplinary guideline development panels charged with generating recommendations based on comprehensive systematic reviews of the evidence. The IOM standards will guide the APA as it generates CPGs that can be used to inform the general public and the practice community regarding the benefits and harms of various treatment options. CPG recommendations are advisory rather than compulsory. When used appropriately, high-quality guidelines can facilitate shared decision making and identify gaps in knowledge.

Development and Validation of a Standardized Tool for Prioritization of Information Sources.

Science.gov (United States)

Akwar, Holy; Kloeze, Harold; Mukhi, Shamir

2016-01-01

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.

Informatics in clinical research in oncology: current state, challenges, and a future perspective.

Science.gov (United States)

Chahal, Amar P S

2011-01-01

The informatics landscape of clinical trials in oncology has changed significantly in the last 10 years. The current state of the infrastructure for clinical trial management, execution, and data management is reviewed. The systems, their functionality, the users, and the standards available to researchers are discussed from the perspective of the oncologist-researcher. Challenges in complexity and in the processing of information are outlined. These challenges include the lack of communication and information-interchange between systems, the lack of simplified standards, and the lack of implementation and adherence to the standards that are available. The clinical toxicology criteria from the National Cancer Institute (CTCAE) are cited as a successful standard in oncology, and HTTP on the Internet is referenced for its simplicity. Differences in the management of information standards between industries are discussed. Possible future advances in oncology clinical research informatics are addressed. These advances include strategic policy review of standards and the implementation of actions to make standards free, ubiquitous, simple, and easily interpretable; the need to change from a local data-capture- or transaction-driven model to a large-scale data-interpretation model that provides higher value to the oncologist and the patient; and the need for information technology investment in a readily available digital educational model for clinical research in oncology that is customizable for individual studies. These new approaches, with changes in information delivery to mobile platforms, will set the stage for the next decade in clinical research informatics.

CliniProteus: A flexible clinical trials information management system

Science.gov (United States)

Mathura, Venkatarajan S; Rangareddy, Mahendiranath; Gupta, Pankaj; Mullan, Michael

2007-01-01

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

Management control and status reports documentation standard and Data Item Descriptions (DID). Volume of the information system life-cycle and documentation standards, volume 5

Science.gov (United States)

Callender, E. David; Steinbacher, Jody

1989-01-01

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.

77 FR 74685 - Chemical Facility Anti-Terrorism Standards (CFATS) Chemical-Terrorism Vulnerability Information...

Science.gov (United States)

2012-12-17

... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2012-0057] Chemical Facility Anti-Terrorism Standards (CFATS) Chemical- Terrorism Vulnerability Information (CVI) AGENCY: National Protection and...: Comments that include trade secrets, confidential commercial or financial information, Chemical-terrorism...

Physician capability to electronically exchange clinical information, 2011.

Science.gov (United States)

Patel, Vaishali; Swain, Matthew J; King, Jennifer; Furukawa, Michael F

2013-10-01

To provide national estimates of physician capability to electronically share clinical information with other providers and to describe variation in exchange capability across states and electronic health record (EHR) vendors using the 2011 National Ambulatory Medical Care Survey Electronic Medical Record Supplement. Survey of a nationally representative sample of nonfederal office-based physicians who provide direct patient care. The survey was administered by mail with telephone follow-up and had a 61% weighted response rate. The overall sample consisted of 4326 respondents. We calculated estimates of electronic exchange capability at the national and state levels, and applied multivariate analyses to examine the association between the capability to exchange different types of clinical information and physician and practice characteristics. In 2011, 55% of physicians had computerized capability to send prescriptions electronically; 67% had the capability to view lab results electronically; 42% were able to incorporate lab results into their EHR; 35% were able to send lab orders electronically; and, 31% exchanged patient clinical summaries with other providers. The strongest predictor of exchange capability is adoption of an EHR. However, substantial variation exists across geography and EHR vendors in exchange capability, especially electronic exchange of clinical summaries. In 2011, a majority of office-based physicians could exchange lab and medication data, and approximately one-third could exchange clinical summaries with patients or other providers. EHRs serve as a key mechanism by which physicians can exchange clinical data, though physicians' capability to exchange varies by vendor and by state.

Guidelines for defining and implementing standard episode of care for hematopoietic stem cell transplantation within the context of clinical trials.

Science.gov (United States)

Majhail, Navneet S; Giralt, Sergio; Bonagura, Anthony; Crawford, Stephen; Farnia, Stephanie; Omel, James L; Pasquini, Marcelo; Saber, Wael; LeMaistre, Charles F

2015-04-01

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.

Developing Archive Information Packages for Data Sets: Early Experiments with Digital Library Standards

Science.gov (United States)

Duerr, R. E.; Yang, M.; Gooyabadi, M.; Lee, C.

2008-12-01

The key to interoperability between systems is often metadata, yet metadata standards in the digital library and data center communities have evolved separately. In the data center world NASA's Directory Interchange Format (DIF), the Content Standard for Digital Geospatial Metadata (CSDGM), and most recently the international Geographic Information: Metadata (ISO 19115:2003) are used for descriptive metadata at the data set level to allow catalog interoperability; but use of anything other than repository- based metadata standards for the individual files that comprise a data set is rare, making true interoperability, at the data rather than data set level, across archives difficult. While the Open Archival Information Systems (OAIS) Reference Model with its call for creating Archive Information Packages (AIP) containing not just descriptive metadata but also preservation metadata is slowly being adopted in the community, the PREservation Metadata Implementation Strategies (PREMIS) standard, the only extant OAIS- compliant preservation metadata standard, has scarcely even been recognized as being applicable to the community. The digital library community in the meantime has converged upon the Metadata Encoding and Transmission Standard (METS) for interoperability between systems as evidenced by support for the standard by digital library systems such as Fedora and Greenstone. METS is designed to allow inclusion of other XML-based standards as descriptive and administrative metadata components. A recent Stanford study suggests that a combination of METS with included FGDC and PREMIS metadata could work well for individual granules of a data set. However, some of the lessons learned by the data center community over the last 30+ years of dealing with digital data are 1) that data sets as a whole need to be preserved and described and 2) that discovery and access mechanisms need to be hierarchical. Only once a user has reviewed a data set description and determined

Quality standards for bone conduction implants.

Science.gov (United States)

Gavilan, Javier; Adunka, Oliver; Agrawal, Sumit; Atlas, Marcus; Baumgartner, Wolf-Dieter; Brill, Stefan; Bruce, Iain; Buchman, Craig; Caversaccio, Marco; De Bodt, Marc T; Dillon, Meg; Godey, Benoit; Green, Kevin; Gstoettner, Wolfgang; Hagen, Rudolf; Hagr, Abdulrahman; Han, Demin; Kameswaran, Mohan; Karltorp, Eva; Kompis, Martin; Kuzovkov, Vlad; Lassaletta, Luis; Li, Yongxin; Lorens, Artur; Martin, Jane; Manoj, Manikoth; Mertens, Griet; Mlynski, Robert; Mueller, Joachim; O'Driscoll, Martin; Parnes, Lorne; Pulibalathingal, Sasidharan; Radeloff, Andreas; Raine, Christopher H; Rajan, Gunesh; Rajeswaran, Ranjith; Schmutzhard, Joachim; Skarzynski, Henryk; Skarzynski, Piotr; Sprinzl, Georg; Staecker, Hinrich; Stephan, Kurt; Sugarova, Serafima; Tavora, Dayse; Usami, Shin-Ichi; Yanov, Yuri; Zernotti, Mario; Zorowka, Patrick; de Heyning, Paul Van

2015-01-01

Bone conduction implants are useful in patients with conductive and mixed hearing loss for whom conventional surgery or hearing aids are no longer an option. They may also be used in patients affected by single-sided deafness. To establish a consensus on the quality standards required for centers willing to create a bone conduction implant program. To ensure a consistently high level of service and to provide patients with the best possible solution the members of the HEARRING network have established a set of quality standards for bone conduction implants. These standards constitute a realistic minimum attainable by all implant clinics and should be employed alongside current best practice guidelines. Fifteen items are thoroughly analyzed. They include team structure, accommodation and clinical facilities, selection criteria, evaluation process, complete preoperative and surgical information, postoperative fitting and assessment, follow-up, device failure, clinical management, transfer of care and patient complaints.

A Platform for Innovation and Standards Evaluation: a Case Study from the OpenMRS Open-Source Radiology Information System.

Science.gov (United States)

Gichoya, Judy W; Kohli, Marc; Ivange, Larry; Schmidt, Teri S; Purkayastha, Saptarshi

2018-05-10

Open-source development can provide a platform for innovation by seeking feedback from community members as well as providing tools and infrastructure to test new standards. Vendors of proprietary systems may delay adoption of new standards until there are sufficient incentives such as legal mandates or financial incentives to encourage/mandate adoption. Moreover, open-source systems in healthcare have been widely adopted in low- and middle-income countries and can be used to bridge gaps that exist in global health radiology. Since 2011, the authors, along with a community of open-source contributors, have worked on developing an open-source radiology information system (RIS) across two communities-OpenMRS and LibreHealth. The main purpose of the RIS is to implement core radiology workflows, on which others can build and test new radiology standards. This work has resulted in three major releases of the system, with current architectural changes driven by changing technology, development of new standards in health and imaging informatics, and changing user needs. At their core, both these communities are focused on building general-purpose EHR systems, but based on user contributions from the fringes, we have been able to create an innovative system that has been used by hospitals and clinics in four different countries. We provide an overview of the history of the LibreHealth RIS, the architecture of the system, overview of standards integration, describe challenges of developing an open-source product, and future directions. Our goal is to attract more participation and involvement to further develop the LibreHealth RIS into an Enterprise Imaging System that can be used in other clinical imaging including pathology and dermatology.

Developing standard transmission system for radiology reporting including key images

International Nuclear Information System (INIS)

Kim, Seon Chil

2007-01-01

Development of hospital information system and Picture Archiving Communication System is not new in the medical field, and the development of internet and information technology are also universal. In the course of such development, however, it is hard to share medical information without a refined standard format. Especially in the department of radiology, the role of PACS has become very important in interchanging information with other disparate hospital information systems. A specific system needs to be developed that radiological reports are archived into a database efficiently. This includes sharing of medical images. A model is suggested in this study in which an internal system is developed where radiologists store necessary images and transmit them is the standard international clinical format, Clinical Document Architecture, and share the information with hospitals. CDA document generator was made to generate a new file format and separate the existing storage system from the new system. This was to ensure the access to required data in XML documents. The model presented in this study added a process where crucial images in reading are inserted in the CDA radiological report generator. Therefore, this study suggests a storage and transmission model for CDA documents, which is different from the existing DICOM SR. Radiological reports could be better shared, when the application function for inserting images and the analysis of standard clinical terms are completed

78 FR 16698 - Chemical Facility Anti-Terrorism Standards (CFATS) Chemical-Terrorism Vulnerability Information...

Science.gov (United States)

2013-03-18

... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2012-0057] Chemical Facility Anti-Terrorism Standards (CFATS) Chemical- Terrorism Vulnerability Information (CVI) AGENCY: National Protection and... notice is also soliciting comments concerning the Information Collection Request, Chemical Facility Anti...

76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

Science.gov (United States)

2011-08-19

... clinical trials of therapeutic drugs and biological products. The draft guidance describes standards... important imaging endpoint is used in a clinical trial of a therapeutic drug or biological product... Services to the Chairman of [[Page 51994

42 CFR 493.1274 - Standard: Cytology.

Science.gov (United States)

2010-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... must be completed before reporting patient results. (2) Laboratory comparison of clinical information... applicable requirements of this subpart K. (h) Documentation. The laboratory must document all control...

Medicaid program; Medicaid Management Information Systems; performance standards--HCFA. General notice.

Science.gov (United States)

1983-05-31

The purpose of this notice is to respond to the comments we received on the Medicaid Management Information Systems Performance Standards that we published in a notice with comment period on June 30, 1981 (46 FR 33653).

Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials.

Science.gov (United States)

Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana

2017-06-15

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.

Analyses to support development of risk-informed separation distances for hydrogen codes and standards.

Energy Technology Data Exchange (ETDEWEB)

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

2009-03-01

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.

The Role of Management as a User of Accounting Information: Implications for Standard Setting

OpenAIRE

Brigitte EIERLE; Wolfgang SCHULTZE

2013-01-01

The aim of this paper is to analyze the question of whether the sole focus of standard setters developing accounting standards that are useful to external users for making decisions about providing resources to the entity result in useful accounting information. To answer this question, we analyzed the relationship between the stewardship function of financial accounting and the demand for information useful in making economic decisions on resource allocation (decision-making demand; decision...

Parent-Adolescent Cross-Informant Agreement in Clinically Referred Samples

DEFF Research Database (Denmark)

Rescorla, Leslie A; Ewing, Grace; Ivanova, Masha Y

2017-01-01

To conduct international comparisons of parent-adolescent cross-informant agreement in clinical samples, we analyzed ratings on the Child Behavior Checklist (CBCL) and Youth Self-Report (YSR) for 6,762 clinically referred adolescents ages 11-18 from 7 societies (M = 14.5 years, SD = 2.0 years; 51...

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

Science.gov (United States)

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2015-12-01

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.

XML, Ontologies, and Their Clinical Applications.

Science.gov (United States)

Yu, Chunjiang; Shen, Bairong

2016-01-01

The development of information technology has resulted in its penetration into every area of clinical research. Various clinical systems have been developed, which produce increasing volumes of clinical data. However, saving, exchanging, querying, and exploiting these data are challenging issues. The development of Extensible Markup Language (XML) has allowed the generation of flexible information formats to facilitate the electronic sharing of structured data via networks, and it has been used widely for clinical data processing. In particular, XML is very useful in the fields of data standardization, data exchange, and data integration. Moreover, ontologies have been attracting increased attention in various clinical fields in recent years. An ontology is the basic level of a knowledge representation scheme, and various ontology repositories have been developed, such as Gene Ontology and BioPortal. The creation of these standardized repositories greatly facilitates clinical research in related fields. In this chapter, we discuss the basic concepts of XML and ontologies, as well as their clinical applications.

A comparison of two standard-setting approaches in high-stakes clinical performance assessment using generalizability theory.

Science.gov (United States)

Richter Lagha, Regina A; Boscardin, Christy K; May, Win; Fung, Cha-Chi

2012-08-01

Scoring clinical assessments in a reliable and valid manner using criterion-referenced standards remains an important issue and directly affects decisions made regarding examinee proficiency. This generalizability study of students' clinical performance examination (CPX) scores examines the reliability of those scores and of their interpretation, particularly according to a newly introduced, "critical actions" criterion-referenced standard and scoring approach. The authors applied a generalizability framework to the performance scores of 477 third-year students attending three different medical schools in 2008. The norm-referenced standard included all station checklist items. The criterion-referenced standard included only those items deemed critical to patient care by a faculty panel. The authors calculated and compared variance components and generalizability coefficients for each standard across six common stations. Norm-referenced scores had moderate generalizability (ρ = 0.51), whereas criterion-referenced scores showed low dependability (φ = 0.20). The estimated 63% of measurement error associated with the person-by-station interaction suggests case specificity. Increasing the number of stations on the CPX from 6 to 24, an impractical solution both for cost and time, would still yield only moderate dependability (φ = 0.50). Though the performance assessment of complex skills, like clinical competence, seems intrinsically valid, careful consideration of the scoring standard and approach is needed to avoid misinterpretation of proficiency. Further study is needed to determine how best to improve the reliability of criterion-referenced scores, by implementing changes to the examination structure, the process of standard-setting, or both.

Antimicrobial Potential of Momordica charantia L. against Multiresistant Standard Species and Clinical Isolates.

Science.gov (United States)

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

2015-11-01

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.

Factors shaping effective utilization of health information technology in urban safety-net clinics.

Science.gov (United States)

George, Sheba; Garth, Belinda; Fish, Allison; Baker, Richard

2013-09-01

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.

Recommendation for measuring clinical outcome in distal radius fractures: a core set of domains for standardized reporting in clinical practice and research.

Science.gov (United States)

Goldhahn, Jörg; Beaton, Dorcas; Ladd, Amy; Macdermid, Joy; Hoang-Kim, Amy

2014-02-01

Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We adopted a process of reviewing evidence on current use of measures and appropriate theoretical frameworks for health and disability to inform a consensus process that was focused on deriving the minimal set of core domains in distal radius fracture. We agreed on the following seven core recommendations: (1) pain and function were regarded as the primary domains, (2) very brief measures were needed for routine administration in clinical practice, (3) these brief measures could be augmented by additional measures that provide more detail or address additional domains for clinical research, (4) measurement of pain should include measures of both intensity and frequency as core attributes, (5) a numeric pain scale, e.g. visual analogue scale or visual numeric scale or the pain subscale of the patient-reported wrist evaluation (PRWE) questionnaires were identified as reliable, valid and feasible measures to measure these concepts, (6) for function, either the Quick Disability of the arm, shoulder and hand questionnaire or PRWE-function subscale was identified as reliable, valid and feasible measures, and (7) a measure of participation and treatment complications should be considered core outcomes for both clinical practice and research. We used a sound methodological approach to form a comprehensive foundation of content for outcomes in the area of distal radius fractures. We recommend the use of symptom and function as separate domains in the ICF core set in clinical research or practice for patients with wrist fracture. Further research is needed to provide more definitive measurement properties of measures across all domains.

Impact of HIPAA's minimum necessary standard on genomic data sharing.

Science.gov (United States)

Evans, Barbara J; Jarvik, Gail P

2018-04-01

This article provides a brief introduction to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule's minimum necessary standard, which applies to sharing of genomic data, particularly clinical data, following 2013 Privacy Rule revisions. This research used the Thomson Reuters Westlaw database and law library resources in its legal analysis of the HIPAA privacy tiers and the impact of the minimum necessary standard on genomic data sharing. We considered relevant example cases of genomic data-sharing needs. In a climate of stepped-up HIPAA enforcement, this standard is of concern to laboratories that generate, use, and share genomic information. How data-sharing activities are characterized-whether for research, public health, or clinical interpretation and medical practice support-affects how the minimum necessary standard applies and its overall impact on data access and use. There is no clear regulatory guidance on how to apply HIPAA's minimum necessary standard when considering the sharing of information in the data-rich environment of genomic testing. Laboratories that perform genomic testing should engage with policy makers to foster sound, well-informed policies and appropriate characterization of data-sharing activities to minimize adverse impacts on day-to-day workflows.

12 CFR Appendix D-2 to Part 208 - Interagency Guidelines Establishing Information Security Standards

Science.gov (United States)

2010-01-01

... Relationships Risk Management Principles,” Nov. 1, 2001; FDIC FIL 68-99, Risk Assessment Tools and Practices for.... Definitions II. Standards for Safeguarding Customer Information A. Information Security Program B. Objectives III. Development and Implementation of Customer Information Security Program A. Involve the Board of...

Satisfying the needs of Japanese cancer patients: a comparative study of detailed and standard informed consent documents.

Science.gov (United States)

Sato, Keiko; Watanabe, Toru; Katsumata, Noriyuki; Sato, Tosiya; Ohashi, Yasuo

2014-02-01

Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety. However, unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills. s To investigate whether a detailed consent form explaining the key elements of informed consent, in comparison to a standard consent form, would increase the comprehension and satisfaction of adult cancer patients. Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer (protocol 01(N-SAS/BC-01)) were randomly selected to receive one of the following four versions: detailed document with graphics, detailed document without graphics, standard document with graphics, and standard document without graphics. The forms were written in plain language from the patients' point of view. A total of 85 patients were administered questionnaires via interview to assess levels of comprehension, satisfaction, and anxiety. Patients demonstrated a strong understanding of information regarding treatment and research. Patient comprehension did not differ significantly between the detailed document arms and the standard document arms. Patient satisfaction level increased according to the amount of information presented in the consent form; most patients preferred the detailed document with graphics. Anxiety and accrual rates in the parent study were not affected by informed consent procedures. Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy. Informed consent can be a significant experience for a population with standard literacy skills, as long as the document is easily comprehensible. Such information should be provided in a format that corresponds with patient needs, education levels, and preferences.

The O3-Vet project: integration of a standard nomenclature of clinical terms in a veterinary electronic medical record for veterinary hospitals.

Science.gov (United States)

Zaninelli, M; Campagnoli, A; Reyes, M; Rojas, V

2012-11-01

In order to improve the hospital information system of the Chilean University Hospital, the Veterinary Medicine School of Universidad de Chile made a research cooperation with Università San Raffaele Roma to develop and test a new release of the O3-Vet software application. O3-Vet was selected by the Chilean University mainly for two reasons: (1) it uses human medicine standardized technologies such as "Health Level 7" (HL7) and "Integrating the Healthcare Enterprise" (IHE), which allow a good level of data sharing and hospital management; (2) it is open source, which means it can be adapted to specific hospital needs. In the new release, a subset of diagnostic terms was added from the "Systematized Nomenclature of Medicine Clinical Terms" (SNOMED CT), selected by the "American Animal Hospital Association" (AAHA) to standardize the filing of clinical data and its retrieval. Results from a limited survey of veterinarians of the University (n=9) show that the new release improved the management of the Chilean University Hospital and the ability to retrieve useful clinical data. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Whole-body magnetic resonance angiography of patients using a standard clinical scanner

Energy Technology Data Exchange (ETDEWEB)

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)

2006-01-01

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.)

Development of Standard Process for Private Information Protection of Medical Imaging Issuance

International Nuclear Information System (INIS)

Park, Bum Jin; Jeong, Jae Ho; Son, Gi Gyeong Son; Kang, Hee Doo; Yoo, Beong Gyu; Lee, Jong Seok

2009-01-01

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

25 CFR 542.16 - What are the minimum internal control standards for information technology?

Science.gov (United States)

2010-04-01

... 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...

2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

Science.gov (United States)

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

2016-12-01

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 ontologically founded architecture for information systems in clinical and epidemiological research.

Science.gov (United States)

Uciteli, Alexandr; Groß, Silvia; Kireyev, Sergej; Herre, Heinrich

2011-08-09

This paper presents an ontologically founded basic architecture for information systems, which are intended to capture, represent, and maintain metadata for various domains of clinical and epidemiological research. Clinical trials exhibit an important basis for clinical research, and the accurate specification of metadata and their documentation and application in clinical and epidemiological study projects represents a significant expense in the project preparation and has a relevant impact on the value and quality of these studies.An ontological foundation of an information system provides a semantic framework for the precise specification of those entities which are presented in this system. This semantic framework should be grounded, according to our approach, on a suitable top-level ontology. Such an ontological foundation leads to a deeper understanding of the entities of the domain under consideration, and provides a common unifying semantic basis, which supports the integration of data and the interoperability between different information systems.The intended information systems will be applied to the field of clinical and epidemiological research and will provide, depending on the application context, a variety of functionalities. In the present paper, we focus on a basic architecture which might be common to all such information systems. The research, set forth in this paper, is included in a broader framework of clinical research and continues the work of the IMISE on these topics.

[Informed consent right of the appraised individuals in forensic clinical examination].

Science.gov (United States)

Li, Ju-Ping; Han, Wei; Gu, Shan-Zhi; Chen, Teng

2015-02-01

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.

The discrepancy between patients and informants on clinician-rated measures in major depressive disorder: implications for clinical trials and clinical practice.

Science.gov (United States)

Peselow, Eric D; Karamians, Reneh; Lord, Marie; Tobia, Gabriel; IsHak, Waguih William

2014-03-01

Clinician-rated measures are used in clinical trials and measurement-based clinical care settings to assess baseline symptoms and treatment outcomes of major depressive disorder (MDD), with a widely held dictum that they are sufficient in assessing the patient's clinical status. In this study, we examined clinician-rated measures of depressive and global symptom severity, obtained by interviewing patients as well as informants in an attempt to examine the potential difference or similarity between these two sources of information. The sample consisted of 89 treatment seeking, DSM-IV diagnosed MDD outpatients treated between 1995 and 2004. The clinician-rated measures used included the Montgomery Åsberg Depression Rating Scale (MADRS), and the Clinical Global Impression Scale (CGI) for Severity. The scores of the clinician-rated measures collected from patients' interviews were compared with those collected from informants' interviews. Clinician-rated scores, collected by interviewing patients, were significantly higher and indicative of greater symptom severity when compared with those collected by interviewing informants. This was true for both the MADRS before (Ppractical in MDD clinical trials or everyday clinical care. The discrepancies observed between the clinician-rated scores obtained from patients and informants emphasize the importance of incorporating collateral information during the assessment and rating of depressive symptom severity in both clinical trials as well as in clinical practice.

Evidence-based health care: development and audit of a clinical standard for research and its impact on an NHS trust.

Science.gov (United States)

Parkin, Claire; Bullock, Ian

2005-04-01

Working within a modern National Health Service in the United Kingdom, the place for research and its dissemination is increasingly important. The organization of this within each National Health Service (NHS) Trust is challenging but nevertheless essential. If health care professionals are to be empowered to adopt an evidence-based approach in both the planning and delivery of care, research aware employees are crucial. This paper highlights the importance of NHS hospital trusts implementing initiatives that will facilitate this process. One such initiative has been the development and survey of a clinical standard for research. The primary development aim was to provide a benchmark standard for all nursing research. The standard was developed to fit within the current dynamic quality improvement (DQI) programme and has directly contributed to an evolving culture of research by shaping nurses' awareness, and offering a support and consultancy network within the Trust. The standard is one aspect of a research awareness programme, with the primary objective of providing guidance and education whilst developing nurses throughout the research process. The planned strategic outcome is to see a positive outcome on the quality of research in the Trust. A baseline survey was conducted to provide a definitive snap shot of research understanding and practice within the Trust following the introduction of the research standard. The standard was developed by a team of clinicians led by a member of the quality team, to ensure that it fitted the DQI structure, and a member of the Nursing Research Unit (NRU). The standard was distributed to every clinical area and 192 nurses were surveyed to evaluate its impact on their awareness of educational opportunities, their use of the consultancy and support service, their use of other support services, their research utilization and research quality. The survey demonstrated that the implementation of the standard had increased awareness

Designing healthcare information technology to catalyse change in clinical care

Directory of Open Access Journals (Sweden)

William Lester

2008-05-01

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.

Information needs for the rapid response team electronic clinical tool.

Science.gov (United States)

Barwise, Amelia; Caples, Sean; Jensen, Jeffrey; Pickering, Brian; Herasevich, Vitaly

2017-10-02

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.

Informed Consent for Inclusion into Clinical Trials: A Serious Subject ...

African Journals Online (AJOL)

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 ...

[Epidemiologic surveillance of contact allergens. The "monitoring series" of IVDK (Information Network ofDermatologic Clinics for Detection and Scientific Evaluation of Contact Allergy].

Science.gov (United States)

Aberer, W; Komericki, P; Uter, W; Hausen, B M; Lessmann, H; Kränke, B; Geier, J; Schnuch, A

2003-08-01

The selection of the most important contact allergens is subject to a continuous change. Several factors may influence the sensitization rates and thus the decision, which substances to include in the standard series of the most frequent allergens. The Information Network of Departments of Dermatology adds substances of interest for a certain time period to the standard series in order to evaluate parameters such as sensitization rate, grade of reaction, and clinical relevance of positive reactions. In 6 testing periods starting in 1996, 13 test substances were evaluated. Due to the results, propolis, compositae mix, and bufexamac were included in the standard series in 1999, while lyral was added in 2002. Sorbitansesquioleat, dispers blue mix, and iodopropynyl butylcarbamate are under further discussion. Substances such as glutaraldehyde and p-aminoazobenzole should be tested in certain risk groups only, whereas the steroids budesonide and tixocortol should be tested when clinically suspected.

Linked Data for Fighting Global Hunger:Experiences in setting standards for Agricultural Information Management

Science.gov (United States)

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.

WaterML, an Information Standard for the Exchange of in-situ hydrological observations

Science.gov (United States)

Valentine, D.; Taylor, P.; Zaslavsky, I.

2012-04-01

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

A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

Science.gov (United States)

Kass, Nancy E; Taylor, Holly A; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

2015-02-01

Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples. © The Author(s) 2014.

76 FR 12712 - Announcing Draft Federal Information Processing Standard (FIPS) 201-2, Personal Identity...

Science.gov (United States)

2011-03-08

...-02] Announcing Draft Federal Information Processing Standard (FIPS) 201-2, Personal Identity..., ``Personal Identity Verification of Federal Employees and Contractors Standard.'' Draft FIPS 201-2 amends... Issuing Personal Identity Verification Cards under HSPD-12.'' The purpose of this change is to update the...

Where is information quality lost at clinical level? A mixed-method study on information systems and data quality in three urban Kenyan ANC clinics.

Science.gov (United States)

Hahn, Daniel; Wanjala, Pepela; Marx, Michael

2013-08-29

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.

Where is information quality lost at clinical level? A mixed-method study on information systems and data quality in three urban Kenyan ANC clinics

Directory of Open Access Journals (Sweden)

Daniel Hahn

2013-08-01

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.

Where is information quality lost at clinical level? A mixed-method study on information systems and data quality in three urban Kenyan ANC clinics

Science.gov (United States)

Hahn, Daniel; Wanjala, Pepela; Marx, Michael

2013-01-01

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

Design and development of a tele-healthcare information system based on web services and HL7 standards.

Science.gov (United States)

Huang, Ean-Wen; Hung, Rui-Suan; Chiou, Shwu-Fen; Liu, Fei-Ying; Liou, Der-Ming

2011-01-01

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.

Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain

Directory of Open Access Journals (Sweden)

Tropp Hans

2005-06-01

Full Text Available Abstract Background The tissue origin of low back pain (LBP or referred lower extremity symptoms (LES may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. Methods We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. Results In a sample of chronic LBP patients (n = 216 with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement

Organising and presenting information.

Science.gov (United States)

Kankanady, Raghavendra; Wells, Marilyn

2013-01-01

Information management can be a daunting process for clinicians, health care providers and policy makers within the health care industry. This chapter discusses the importance of information classification and information architecture in the information economy and specific challenges faced within the health care industry. The healthcare sector has industry specific requirements for information management, standards and specifications for information presentation. Classification of information based on information criticality and the value in the health care industry is discussed in this paper. Presentation of information with reference to eHealth standards and specifications for healthcare information systems and their key requirements are also discussed, as are information architecture for eHealth implementation in Australia. This chapter also touches on information management and clinical governance since the importance of information governance is discussed by various researchers and how this is becoming of value to healthcare information management.

The Economics of Standards and Standardization in Information and Communication Technologies

DEFF Research Database (Denmark)

Pedersen, Mogens Kuhn; Fomin, Vladislav V.

2006-01-01

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?...

Models of information exchange between radio interfaces of Wi-Fi group of standards

Science.gov (United States)

Litvinskaya, O. S.

2018-05-01

This paper offers models of information exchange between radio interfaces of the Wi-Fi group of standards by the example of a real facility management system for the oil and gas industry. Interaction between the MU-MIMO and MIMO technologies is analyzed. An optimal variant of information exchange is proposed.

What influences assessors' internalised standards?

International Nuclear Information System (INIS)

Poole, C.; Boland, J.

2016-01-01

Purpose: The meaning assessors attach to assessment criteria during clinical placement is under-researched. While personal beliefs, values or expectations may influence judgements, there is scant evidence of how this manifests in a clinical attachment setting. This research explored the concept and source of internalised standards and how these may influence judgements. Methods: This study, within the constructivist paradigm, was informed by the principles of grounded theory. Seven radiation therapists, purposefully selected, were interviewed face-to-face using semi-structured interviews. The sample size allowed for the gathering of sufficient data for in-depth thematic analysis, using the functionality of CAQDAS (NVivo 9). Results: Radiation therapists' judgements when assessing students were influenced by their previous experience. They had different expectations of the appropriate standard for each criterion on students' assessment forms – relating to technical ability, clinical knowledge and attitude. They had their own set of values, or expectations which informed ‘internalised standards’ which influenced their judgements about student performance. Prior experience – as students and as qualified professionals – influenced these decisions. Conclusion: Assessment of students' performance may differ depending on the clinician conducting the assessment. Even where assessors are given the same criteria and training, this does not ensure reliability, as judgements are influenced by their internalised standards. This has implications for the design of more appropriate assessor training which recognises and addresses this phenomenon. These results will be of interest to radiation therapists, radiographers, medical educators, allied health professionals and any academic or professional body with responsibility for ensuring that we qualify competent practitioners. - Highlights: • Reliability of clinical assessment is of the upmost importance

Spontaneously Reported Symptoms by Informants Are Associated with Clinical Severity in Dementia Help-Seekers.

Science.gov (United States)

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

2017-09-01

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.

Standardizing information exchange towards the end user. Present data models with two way communication over the Internet

International Nuclear Information System (INIS)

Saele, Hanne; Graabak, Ingeborg; Tangen, Grethe

2000-01-01

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

Clinical Information Systems as the Backbone of a Complex Information Logistics Process: Findings from the Clinical Information Systems Perspective for 2016.

Science.gov (United States)

Hackl, W O; Ganslandt, T

2017-08-01

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.

75 FR 32472 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee...

Science.gov (United States)

2010-06-08

... Coordinator for Health Information Technology AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice of committee recommendations and invitation for public input... Coordinator for Health Information Technology (ONC). Name of Committee: HIT Standards Committee. General...

New pricing approaches for bundled payments: Leveraging clinical standards and regional variations to target avoidable utilization.

Science.gov (United States)

Hellsten, Erik; Chu, Scally; Crump, R Trafford; Yu, Kevin; Sutherland, Jason M

2016-03-01

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.

Text de-identification for privacy protection: a study of its impact on clinical text information content.

Science.gov (United States)

Meystre, Stéphane M; Ferrández, Óscar; Friedlin, F Jeffrey; South, Brett R; Shen, Shuying; Samore, Matthew H

2014-08-01

As more and more electronic clinical information is becoming easier to access for secondary uses such as clinical research, approaches that enable faster and more collaborative research while protecting patient privacy and confidentiality are becoming more important. Clinical text de-identification offers such advantages but is typically a tedious manual process. Automated Natural Language Processing (NLP) methods can alleviate this process, but their impact on subsequent uses of the automatically de-identified clinical narratives has only barely been investigated. In the context of a larger project to develop and investigate automated text de-identification for Veterans Health Administration (VHA) clinical notes, we studied the impact of automated text de-identification on clinical information in a stepwise manner. Our approach started with a high-level assessment of clinical notes informativeness and formatting, and ended with a detailed study of the overlap of select clinical information types and Protected Health Information (PHI). To investigate the informativeness (i.e., document type information, select clinical data types, and interpretation or conclusion) of VHA clinical notes, we used five different existing text de-identification systems. The informativeness was only minimally altered by these systems while formatting was only modified by one system. To examine the impact of de-identification on clinical information extraction, we compared counts of SNOMED-CT concepts found by an open source information extraction application in the original (i.e., not de-identified) version of a corpus of VHA clinical notes, and in the same corpus after de-identification. Only about 1.2-3% less SNOMED-CT concepts were found in de-identified versions of our corpus, and many of these concepts were PHI that was erroneously identified as clinical information. To study this impact in more details and assess how generalizable our findings were, we examined the overlap between

Resolution improvement of brain PET images using prior information from MRI: clinical application on refractory epilepsy

International Nuclear Information System (INIS)

Silva-Rodríguez, Jesus; Tsoumpas, Charalampos; Aguiar, Pablo; Cortes, Julia; Urdaneta, Jesus Lopez

2015-01-01

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

Resolution improvement of brain PET images using prior information from MRI: clinical application on refractory epilepsy

Energy Technology Data Exchange (ETDEWEB)

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)

2015-05-18

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

Research on information models for the construction schedule management based on the IFC standard

Directory of Open Access Journals (Sweden)

Weirui Xue

2015-05-01

Full Text Available Purpose: The purpose of this article is to study the description and extension of the Industry Foundation Classes (IFC standard in construction schedule management, which achieves the information exchange and sharing among the different information systems and stakeholders, and facilitates the collaborative construction in the construction projects. Design/methodology/approach: The schedule information processing and coordination are difficult in the complex construction project. Building Information Modeling (BIM provides the platform for exchanging and sharing information among information systems and stakeholders based on the IFC standard. Through analyzing the schedule plan, implementing, check and control, the information flow in the schedule management is reflected based on the IDEF. According to the IFC4, the information model for the schedule management is established, which not only includes the each aspect of the schedule management, but also includes the cost management, the resource management, the quality management and the risk management. Findings: The information requirement for the construction schedule management can be summarized into three aspects: the schedule plan information, the implementing information and the check and control information. The three aspects can be described through the existing and extended entities of IFC4, and the information models are established. Originality/value: The main contribution of the article is to establish the construction schedule management information model, which achieves the information exchange and share in the construction project, and facilitates the development of the application software to meet the requirements of the construction project.

Standards for collection of identifying information for health record keeping

International Nuclear Information System (INIS)

Carpenter, M.; Fair, M.E.; Lalonde, P.; Scott, T.

1988-09-01

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

Information technology for clinical, translational and comparative effectiveness research. Findings from the section clinical research informatics.

Science.gov (United States)

Daniel, C; Choquet, R

2013-01-01

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.

The role of effective communication in achieving informed consent for clinical trials.

Science.gov (United States)

Pick, Andrew; Gilbert, Kayleigh; McCaul, James

2014-11-11

Informed consent is fundamental to the protection of the rights, safety and wellbeing of patients in clinical research. For consent to be valid, patients must first be given all the information they need about the proposed research to be able to decide whether they would like to take part. This material should be presented in a way that is easy for them to understand. This article explores the importance of communication in clinical research, and how more effective communication with patients during the informed consent process can ensure they are fully informed.

Standardized System of Nuclear Safety Information for the Promotion of Transparency and Openness

Energy Technology Data Exchange (ETDEWEB)

Lee, Gihyung; Kim, Sanghyun; Lee, Gyehwi; Yoon, Yeonhwa; Song, Song Hyerim; Jeong, Jina [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of); Byun, Jaehyung; Seo, Jonghwan [Dong-A Univ., Busan (Korea, Republic of)

2013-05-15

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

Standardized System of Nuclear Safety Information for the Promotion of Transparency and Openness

International Nuclear Information System (INIS)

Lee, Gihyung; Kim, Sanghyun; Lee, Gyehwi; Yoon, Yeonhwa; Song, Song Hyerim; Jeong, Jina; Byun, Jaehyung; Seo, Jonghwan

2013-01-01

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

Investigating the congruence of crowdsourced information with official government data: the case of pediatric clinics.

Science.gov (United States)

Kim, Minki; Jung, Yuchul; Jung, Dain; Hur, Cinyoung

2014-02-03

Health 2.0 is a benefit to society by helping patients acquire knowledge about health care by harnessing collective intelligence. However, any misleading information can directly affect patients' choices of hospitals and drugs, and potentially exacerbate their health condition. This study investigates the congruence between crowdsourced information and official government data in the health care domain and identifies the determinants of low congruence where it exists. In-line with infodemiology, we suggest measures to help the patients in the regions vulnerable to inaccurate health information. We text-mined multiple online health communities in South Korea to construct the data for crowdsourced information on public health services (173,748 messages). Kendall tau and Spearman rank order correlation coefficients were used to compute the differences in 2 ranking systems of health care quality: actual government evaluations of 779 hospitals and mining results of geospecific online health communities. Then we estimated the effect of sociodemographic characteristics on the level of congruence by using an ordinary least squares regression. The regression results indicated that the standard deviation of married women's education (P=.046), population density (P=.01), number of doctors per pediatric clinic (P=.048), and birthrate (P=.002) have a significant effect on the congruence of crowdsourced data (adjusted R²=.33). Specifically, (1) the higher the birthrate in a given region, (2) the larger the variance in educational attainment, (3) the higher the population density, and (4) the greater the number of doctors per clinic, the more likely that crowdsourced information from online communities is congruent with official government data. To investigate the cause of the spread of misleading health information in the online world, we adopted a unique approach by associating mining results on hospitals from geospecific online health communities with the sociodemographic

Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

Science.gov (United States)

2013-01-01

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

Online drug databases: a new method to assess and compare inclusion of clinically relevant information.

Science.gov (United States)

Silva, Cristina; Fresco, Paula; Monteiro, Joaquim; Rama, Ana Cristina Ribeiro

2013-08-01

Evidence-Based Practice requires health care decisions to be based on the best available evidence. The model "Information Mastery" proposes that clinicians should use sources of information that have previously evaluated relevance and validity, provided at the point of care. Drug databases (DB) allow easy and fast access to information and have the benefit of more frequent content updates. Relevant information, in the context of drug therapy, is that which supports safe and effective use of medicines. Accordingly, the European Guideline on the Summary of Product Characteristics (EG-SmPC) was used as a standard to evaluate the inclusion of relevant information contents in DB. To develop and test a method to evaluate relevancy of DB contents, by assessing the inclusion of information items deemed relevant for effective and safe drug use. Hierarchical organisation and selection of the principles defined in the EGSmPC; definition of criteria to assess inclusion of selected information items; creation of a categorisation and quantification system that allows score calculation; calculation of relative differences (RD) of scores for comparison with an "ideal" database, defined as the one that achieves the best quantification possible for each of the information items; pilot test on a sample of 9 drug databases, using 10 drugs frequently associated in literature with morbidity-mortality and also being widely consumed in Portugal. Main outcome measure Calculate individual and global scores for clinically relevant information items of drug monographs in databases, using the categorisation and quantification system created. A--Method development: selection of sections, subsections, relevant information items and corresponding requisites; system to categorise and quantify their inclusion; score and RD calculation procedure. B--Pilot test: calculated scores for the 9 databases; globally, all databases evaluated significantly differed from the "ideal" database; some DB performed

A Research Agenda for the Common Core State Standards: What Information Do Policymakers Need?

Science.gov (United States)

Rentner, Diane Stark; Ferguson, Maria

2014-01-01

This report looks specifically at the information and data needs of policymakers related to the Common Core State Standards (CCSS) and the types of research that could provide this information. The ideas in this report were informed by a series of meetings and discussions about a possible research agenda for the Common Core, sponsored by the…

The National Hip Fracture Database (NHFD) - Using a national clinical audit to raise standards of nursing care.

Science.gov (United States)

Johansen, Antony; Boulton, Christopher; Hertz, Karen; Ellis, Michael; Burgon, Vivienne; Rai, Sunil; Wakeman, Rob

2017-08-01

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.

Medicaid management information systems performance standards: Health Care Financing Administration. Notice with comment period.

Science.gov (United States)

1981-06-30

This notice contains performance standards (review elements and factors). We are required by section 1903(r)(6)(E) of the Social Security Act to notify all States of proposed procedures, standards, and other requirements at least one quarter prior to the fiscal year in which the procedures, standards, and other requirements will be used for Medicaid Management Information Systems reapproval reviews. This Notice meets that statutory requirements. By October 1, 1981, we will use the performance standards and existing systems requirements when conducting the annual review of State system performance.

Development of a clinical information tool for the electronic medical record: a case study.

Science.gov (United States)

Epstein, Barbara A; Tannery, Nancy H; Wessel, Charles B; Yarger, Frances; LaDue, John; Fiorillo, Anthony B

2010-07-01

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.

75 FR 60171 - Proposed Information Collection (Credit Underwriting Standards and Procedures for Processing VA...

Science.gov (United States)

2010-09-29

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0521] Proposed Information Collection (Credit Underwriting Standards and Procedures for Processing VA Guaranteed Loans) Activity: Comment Request AGENCY... comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act...

78 FR 60379 - Proposed Information Collection (Credit Underwriting Standards and Procedures for Processing VA...

Science.gov (United States)

2013-10-01

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0521] Proposed Information Collection (Credit Underwriting Standards and Procedures for Processing VA Guaranteed Loans) Activity: Comment Request AGENCY... comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act...

A review of medical terminology standards and structured reporting.

Science.gov (United States)

Awaysheh, Abdullah; Wilcke, Jeffrey; Elvinger, François; Rees, Loren; Fan, Weiguo; Zimmerman, Kurt

2018-01-01

Much effort has been invested in standardizing medical terminology for representation of medical knowledge, storage in electronic medical records, retrieval, reuse for evidence-based decision making, and for efficient messaging between users. We only focus on those efforts related to the representation of clinical medical knowledge required for capturing diagnoses and findings from a wide range of general to specialty clinical perspectives (e.g., internists to pathologists). Standardized medical terminology and the usage of structured reporting have been shown to improve the usage of medical information in secondary activities, such as research, public health, and case studies. The impact of standardization and structured reporting is not limited to secondary activities; standardization has been shown to have a direct impact on patient healthcare.

Standardization of Data for Clinical Use and Research in Spinal Cord Injury

DEFF Research Database (Denmark)

Biering-Sørensen, Fin; Noonan, Vanessa K

2016-01-01

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...

Automated identification of wound information in clinical notes of patients with heart diseases: Developing and validating a natural language processing application.

Science.gov (United States)

Topaz, Maxim; Lai, Kenneth; Dowding, Dawn; Lei, Victor J; Zisberg, Anna; Bowles, Kathryn H; Zhou, Li

2016-12-01

Electronic health records are being increasingly used by nurses with up to 80% of the health data recorded as free text. However, only a few studies have developed nursing-relevant tools that help busy clinicians to identify information they need at the point of care. This study developed and validated one of the first automated natural language processing applications to extract wound information (wound type, pressure ulcer stage, wound size, anatomic location, and wound treatment) from free text clinical notes. First, two human annotators manually reviewed a purposeful training sample (n=360) and random test sample (n=1100) of clinical notes (including 50% discharge summaries and 50% outpatient notes), identified wound cases, and created a gold standard dataset. We then trained and tested our natural language processing system (known as MTERMS) to process the wound information. Finally, we assessed our automated approach by comparing system-generated findings against the gold standard. We also compared the prevalence of wound cases identified from free-text data with coded diagnoses in the structured data. The testing dataset included 101 notes (9.2%) with wound information. The overall system performance was good (F-measure is a compiled measure of system's accuracy=92.7%), with best results for wound treatment (F-measure=95.7%) and poorest results for wound size (F-measure=81.9%). Only 46.5% of wound notes had a structured code for a wound diagnosis. The natural language processing system achieved good performance on a subset of randomly selected discharge summaries and outpatient notes. In more than half of the wound notes, there were no coded wound diagnoses, which highlight the significance of using natural language processing to enrich clinical decision making. Our future steps will include expansion of the application's information coverage to other relevant wound factors and validation of the model with external data. Copyright © 2016 Elsevier Ltd. All

Effectiveness of Standardized Patient Simulations in Teaching Clinical Communication Skills to Dental Students.

Science.gov (United States)

McKenzie, Carly T; Tilashalski, Ken R; Peterson, Dawn Taylor; White, Marjorie Lee

2017-10-01

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.

75 FR 16126 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee...

Science.gov (United States)

2010-03-31

... Coordinator for Health Information Technology, HHS. ACTION: Notice of meeting. This notice announces a... Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Standards... and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. 2010...

Automatic exchange of information: towards a new global standard of tax transparency

OpenAIRE

Miguel Eduardo Pecho Trigueros

2014-01-01

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...

Patent challenges for standard-setting in the global economy : lessons from information and communication industry

NARCIS (Netherlands)

Maskus, K.; Merrill, S.A.; Bekkers, R.N.A.; Sandy Block, Marc; Contreras, Jorge; Gilbert, Richard; Goodman, David; Marasco, Amy; Simcoe, Tim; Smoot, Oliver; Suttmeier, Richard; Updegrove, Andrew

2014-01-01

Patent Challenges for Standard-Setting in the Global Economy: Lessons from Information and Communication Technology examines how leading national and multinational standard-setting organizations (SSOs) address patent disclosures, licensing terms, transfers of patent ownership, and other issues that

Clinical professional governance for detailed clinical models.

Science.gov (United States)

Goossen, William; Goossen-Baremans, Anneke

2013-01-01

This chapter describes the need for Detailed Clinical Models for contemporary Electronic Health Systems, data exchange and data reuse. It starts with an explanation of the components related to Detailed Clinical Models with a brief summary of knowledge representation, including terminologies representing clinic relevant "things" in the real world, and information models that abstract these in order to let computers process data about these things. Next, Detailed Clinical Models are defined and their purpose is described. It builds on existing developments around the world and accumulates in current work to create a technical specification at the level of the International Standards Organization. The core components of properly expressed Detailed Clinical Models are illustrated, including clinical knowledge and context, data element specification, code bindings to terminologies and meta-information about authors, versioning among others. Detailed Clinical Models to date are heavily based on user requirements and specify the conceptual and logical levels of modelling. It is not precise enough for specific implementations, which requires an additional step. However, this allows Detailed Clinical Models to serve as specifications for many different kinds of implementations. Examples of Detailed Clinical Models are presented both in text and in Unified Modelling Language. Detailed Clinical Models can be positioned in health information architectures, where they serve at the most detailed granular level. The chapter ends with examples of projects that create and deploy Detailed Clinical Models. All have in common that they can often reuse materials from earlier projects, and that strict governance of these models is essential to use them safely in health care information and communication technology. Clinical validation is one point of such governance, and model testing another. The Plan Do Check Act cycle can be applied for governance of Detailed Clinical Models

Use and clinical efficacy of standard and health information technology fall risk assessment tools.

Science.gov (United States)

Teh, Ruth C; Wilson, Anne; Ranasinghe, Damith; Visvanathan, Renuka

2017-12-01

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 falls. Hospital fall rates trended towards reduction on AMU (4.20 vs 6.96, P = 0.15) and increase on GEM (10.98 vs 6.52, P = 0.54) with HIT tool implementation. Health information 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.

77 FR 33002 - Proposed Extension of Existing Information Collection; Health Standards for Diesel Particulate...

Science.gov (United States)

2012-06-04

... 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...

75 FR 76082 - Agency Information Collection (Credit Underwriting Standards and Procedures for Processing VA...

Science.gov (United States)

2010-12-07

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0521] Agency Information Collection (Credit Underwriting Standards and Procedures for Processing VA Guaranteed Loans) Activity Under OMB Review AGENCY... information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA...

The quest to standardize hemodialysis care.

Science.gov (United States)

Hegbrant, Jörgen; Gentile, Giorgio; Strippoli, Giovanni F M

2011-01-01

A large global dialysis provider's core activities include providing dialysis care with excellent quality, ensuring a low variability across the clinic network and ensuring strong focus on patient safety. In this article, we summarize the pertinent components of the quality assurance and safety program of the Diaverum Renal Services Group. Concerning medical performance, the key components of a successful quality program are setting treatment targets; implementing evidence-based guidelines and clinical protocols; consistently, regularly, prospectively and accurately collecting data from all clinics in the network; processing collected data to provide feedback to clinics in a timely manner, incorporating information on interclinic and intercountry variations; and revising targets, guidelines and clinical protocols based on sound scientific data. The key activities for ensuring patient safety include a standardized approach to education, i.e. a uniform education program including control of theoretical knowledge and clinical competencies; implementation of clinical policies and procedures in the organization in order to reduce variability and potential defects in clinic practice; and auditing of clinical practice on a regular basis. By applying a standardized and systematic continuous quality improvement approach throughout the entire organization, it has been possible for Diaverum to progressively improve medical performance and ensure patient safety. Copyright © 2011 S. Karger AG, Basel.

Clinical trial or standard treatment? Shared decision making at the department of oncology

DEFF Research Database (Denmark)

Gregersen, Trine Ammentorp; Birkelund, Regner; Ammentorp, Jette

2016-01-01

Title: Clinical trial or standard treatment? Shared decision making at the department of oncology. Authors: Ph.d. student, Trine A. Gregersen. Trine.gregersen@rsyd.dk. Department of Oncology. Health Services Research Unit Lillebaelt Hospital / IRS University of Southern Denmark. Professor, Regner...... are involved in difficult treatment decisions including participation in clinical trials. The literature indicates that the decision is very often based on little knowledge about the treatment and that many patients who have consented to participate in a clinical trial are not always aware...... that they are participating in a trial. This place great demand on the healthcare providers’ ability to involve and advise patients in the decisions. The aim of this study is to investigate the characteristics of the communication when decisions about participation in clinical oncology trial are made and the patients...

[Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].

Science.gov (United States)

Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador

2016-10-01

Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

75 FR 151 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee...

Science.gov (United States)

2010-01-04

... Coordinator for Health Information Technology, HHS. ACTION: Notice of meeting. This notice announces a... Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Standards... Programs and Coordination Office of the National Coordinator for Health Information Technology. [FR Doc. E9...

On standardization of basic datasets of electronic medical records in traditional Chinese medicine.

Science.gov (United States)

Zhang, Hong; Ni, Wandong; Li, Jing; Jiang, Youlin; Liu, Kunjing; Ma, Zhaohui

2017-12-24

Standardization of electronic medical record, so as to enable resource-sharing and information exchange among medical institutions has become inevitable in view of the ever increasing medical information. The current research is an effort towards the standardization of basic dataset of electronic medical records in traditional Chinese medicine. In this work, an outpatient clinical information model and an inpatient clinical information model are created to adequately depict the diagnosis processes and treatment procedures of traditional Chinese medicine. To be backward compatible with the existing dataset standard created for western medicine, the new standard shall be a superset of the existing standard. Thus, the two models are checked against the existing standard in conjunction with 170,000 medical record cases. If a case cannot be covered by the existing standard due to the particularity of Chinese medicine, then either an existing data element is expanded with some Chinese medicine contents or a new data element is created. Some dataset subsets are also created to group and record Chinese medicine special diagnoses and treatments such as acupuncture. The outcome of this research is a proposal of standardized traditional Chinese medicine medical records datasets. The proposal has been verified successfully in three medical institutions with hundreds of thousands of medical records. A new dataset standard for traditional Chinese medicine is proposed in this paper. The proposed standard, covering traditional Chinese medicine as well as western medicine, is expected to be soon approved by the authority. A widespread adoption of this proposal will enable traditional Chinese medicine hospitals and institutions to easily exchange information and share resources. Copyright © 2017. Published by Elsevier B.V.

The Application of Standards and Recommendations to Clinical Ethics Consultation in Practice: An Evaluation at German Hospitals.

Science.gov (United States)

Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian

2017-06-01

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.

77 FR 38634 - Request for Information: Collection and Use of Patient Work Information in the Clinical Setting...

Science.gov (United States)

2012-06-28

... (specialty) health care: At your clinical facility, how is the patient's work information collected... the Clinical Setting: Electronic Health Records AGENCY: The National Institute for Occupational Safety... Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of...

Clinical and radiological instability following standard fenestration discectomy

Directory of Open Access Journals (Sweden)

Mascarenhas Amrithlal

2009-01-01

signs of instability are seen even in asymptomatic patients and so are not as reliable as clinical signs of instability. Standard fenestration discectomy does not destabilize the spine more than microdiscectomy.

Building clinical data groups for electronic medical record in China.

Science.gov (United States)

Tu, Haibo; Yu, Yingtao; Yang, Peng; Tang, Xuejun; Hu, Jianping; Rao, Keqin; Pan, Feng; Xu, Yongyong; Liu, Danhong

2012-04-01

This article aims at building clinical data groups for Electronic Medical Records (EMR) in China. These data groups can be reused as basic information units in building the medical sheets of Electronic Medical Record Systems (EMRS) and serve as part of its implementation guideline. The results were based on medical sheets, the forms that are used in hospitals, which were collected from hospitals. To categorize the information in these sheets into data groups, we adopted the Health Level 7 Clinical Document Architecture Release 2 Model (HL7 CDA R2 Model). The regulations and legal documents concerning health informatics and related standards in China were implemented. A set of 75 data groups with 452 data elements was created. These data elements were atomic items that comprised the data groups. Medical sheet items contained clinical records information and could be described by standard data elements that exist in current health document protocols. These data groups match different units of the CDA model. Twelve data groups with 87 standardized data elements described EMR headers, and 63 data groups with 405 standardized data elements constituted the body. The later 63 data groups in fact formed the sections of the model. The data groups had two levels. Those at the first level contained both the second level data groups and the standardized data elements. The data groups were basically reusable information units that served as guidelines for building EMRS and that were used to rebuild a medical sheet and serve as templates for the clinical records. As a pilot study of health information standards in China, the development of EMR data groups combined international standards with Chinese national regulations and standards, and this was the most critical part of the research. The original medical sheets from hospitals contain first hand medical information, and some of their items reveal the data types characteristic of the Chinese socialist national health system

A proposed clinical decision support architecture capable of supporting whole genome sequence information.

Science.gov (United States)

Welch, Brandon M; Loya, Salvador Rodriguez; Eilbeck, Karen; Kawamoto, Kensaku

2014-04-04

Whole genome sequence (WGS) information may soon be widely available to help clinicians personalize the care and treatment of patients. However, considerable barriers exist, which may hinder the effective utilization of WGS information in a routine clinical care setting. Clinical decision support (CDS) offers a potential solution to overcome such barriers and to facilitate the effective use of WGS information in the clinic. However, genomic information is complex and will require significant considerations when developing CDS capabilities. As such, this manuscript lays out a conceptual framework for a CDS architecture designed to deliver WGS-guided CDS within the clinical workflow. To handle the complexity and breadth of WGS information, the proposed CDS framework leverages service-oriented capabilities and orchestrates the interaction of several independently-managed components. These independently-managed components include the genome variant knowledge base, the genome database, the CDS knowledge base, a CDS controller and the electronic health record (EHR). A key design feature is that genome data can be stored separately from the EHR. This paper describes in detail: (1) each component of the architecture; (2) the interaction of the components; and (3) how the architecture attempts to overcome the challenges associated with WGS information. We believe that service-oriented CDS capabilities will be essential to using WGS information for personalized medicine.

Innovating cystic fibrosis clinical trial designs in an era of successful standard of care therapies.

Science.gov (United States)

VanDevanter, Donald R; Mayer-Hamblett, Nicole

2017-11-01

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.

YouTube Videos as a Source of Information About Clinical Trials: Observational Study.

Science.gov (United States)

Hillyer, Grace Clarke; MacLean, Sarah A; Beauchemin, Melissa; Basch, Corey H; Schmitt, Karen M; Segall, Leslie; Kelsen, Moshe; Brogan, Frances L; Schwartz, Gary K

2018-06-26

Clinical trials are essential to the advancement of cancer treatment but fewer than 5% of adult cancer patients enroll in a trial. A commonly cited barrier to participation is the lack of understanding about clinical trials. Since the internet is a popular source of health-related information and YouTube is the second most visited website in the world, we examined the content of the top 115 YouTube videos about clinical trials to evaluate clinical trial information available through this medium. YouTube videos posted prior to March 2017 were searched using selected keywords. A snowballing technique was used to identify videos wherein sequential screening of the autofill search results for each set of keywords was conducted. Video characteristics (eg, number of views and video length) were recorded. The content was broadly grouped as related to purpose, phases, design, safety and ethics, and participant considerations. Stepwise multivariable logistic regression analysis was conducted to assess associations between video type (cancer vs noncancer) and video characteristics and content. In total, 115 videos were reviewed. Of these, 46/115 (40.0%) were cancer clinical trials videos and 69/115 (60.0%) were noncancer/general clinical trial videos. Most videos were created by health care organizations/cancer centers (34/115, 29.6%), were oriented toward patients (67/115, 58.3%) and the general public (68/115, 59.1%), and were informational (79/115, 68.7%); altruism was a common theme (31/115, 27.0%). Compared with noncancer videos, cancer clinical trials videos more frequently used an affective communication style and mentioned the benefits of participation. Cancer clinical trial videos were also much more likely to raise the issue of costs associated with participation (odds ratio [OR] 5.93, 95% CI 1.15-29.46) and advise patients to communicate with their physician about cancer clinical trials (OR 4.94, 95% CI 1.39-17.56). Collectively, YouTube clinical trial videos

Ethics in clinical research: need for assessing comprehension of informed consent form?

Science.gov (United States)

Shafiq, Nusrat; Malhotra, Samir

2011-03-01

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.

Senior Information Officials Standard

Science.gov (United States)

This document establishes the (SIOs) as the Environmental Protection Agency’s (EPA) primary points of accountability for the effective oversight, coordination, and management of information and information technology (IT)

A clinical nutritional information system with personalized nutrition assessment.

Science.gov (United States)

Kuo, Su-E; Lai, Hui-San; Hsu, Jen-Ming; Yu, Yao-Chang; Zheng, Dong-Zhe; Hou, Ting-Wei

2018-03-01

Traditional nutrition evaluations not only require the use of numerous tables and lists to provide sufficient recommendations for patients' diets but are also very time-consuming due to cross-referencing and calculations. To personalize patient assessments, this study implemented a Clinical Nutritional Information System (CNIS) to help hospital dietitians perform their daily work more effectively in terms of time management and paper work. The CNIS mainly targets in-patients who require cancer-nutrition counselling. The development of the CNIS occurred in three phases. Phase 1 included system design and implementation based on the Nutrition Care Process and Model (NCPM) and the Patient Nutrition Care Process. Phase 2 involved a survey to characterize the efficiency, quality and accuracy of the CNIS. In Phase 3, a second survey was conducted to determine how well dietitians had adapted to the system and the extent of improvement in efficiency after the CNIS had been available online for three years. The work time requirements decreased by approximately 58% with the assistance of the CNIS. Of the dietitians who used the CNIS, 95% reported satisfaction, with 91.66% indicating that the CNIS was really helpful in their work. However, some shortcomings were also evident according to the results. Dietitians favoured the standardization of nutritional intervention and monitoring. The CNIS meets the needs of dietitians by increasing the quality of nutritional interventions by providing accurate calculations and cross-referencing for information regarding patients' conditions, with the benefit of decreasing the processing time, such as handwritten documentation. In addition, the CNIS also helps dietitians statistically analyse each patient's personal nutritional needs to achieve nutritional improvement. Copyright © 2017 Elsevier B.V. All rights reserved.

Informed Consent for Inclusion into Clinical Trials: A Serious Subject ...

African Journals Online (AJOL)

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 ...

Predictors of clinical outcome following lumbar disc surgery

DEFF Research Database (Denmark)

Hebert, Jeffrey J; Fritz, Julie; Koppenhaver, S.L.

2016-01-01

scheduled for first time, single-level lumbar discectomy. Participants underwent a standardized preoperative evaluation including real-time ultrasound imaging assessment of lumbar multifidus function, and an 8-week postoperative rehabilitation programme. Clinical outcome was defined by change in disability....... CONCLUSIONS: Information gleaned from the clinical history and physical examination helps to identify patients more likely to succeed with lumbar disc surgery. While this study helps to inform clinical practice, additional research confirming these results is required prior to confident clinical...

Concepts of Information Literacy and Information Literacy Standards among Undergraduate Students in Public and Private Universities in the State of Kuwait

Science.gov (United States)

Al-Issa, Reham E.

2013-01-01

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…

To compare PubMed Clinical Queries and UpToDate in teaching information mastery to clinical residents: a crossover randomized controlled trial.

Science.gov (United States)

Sayyah Ensan, Ladan; Faghankhani, Masoomeh; Javanbakht, Anna; Ahmadi, Seyed-Foad; Baradaran, Hamid Reza

2011-01-01

To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (PPubMed Clinical Queries (PPubMed Clinical Queries users (PPubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.

Pharmacogenetics Informed Decision Making in Adolescent Psychiatric Treatment: A Clinical Case Report

Directory of Open Access Journals (Sweden)

Teri Smith

2015-02-01

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.

Impact and user satisfaction of a clinical information portal embedded in an electronic health record.

Science.gov (United States)

Tannery, Nancy H; Epstein, Barbara A; Wessel, Charles B; Yarger, Frances; LaDue, John; Klem, Mary Lou

2011-01-01

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.

Clinical information has low sensitivity for postmortem diagnosis of heart valve disease.

Science.gov (United States)

Coffey, Sean; Harper, Andrew R; Cairns, Benjamin J; Roberts, Ian Sd; Prendergast, Bernard D

2017-07-01

Accuracy of routinely collected information concerning cause of death is essential for public health and health systems planning. Since clinical examination has relatively low sensitivity for detection of valvular heart disease (VHD), mortality data based on clinical information alone might routinely underestimate the number of deaths due to VHD. We compared autopsy findings against premortem clinical information for 8198 consecutive adult postmortems (mean age 69.1 years, 61.3% men), performed in a single UK tertiary referral centre with on-site cardiac surgical facilities over a 10-year period (2004-2013) during which 21% of the adult population underwent postmortem examination. Following postmortem, VHD was the principal cause of death in 165 individuals (2.0%), a principal or contributory cause ('any cause') of death in 326 (4.0%) and an incidental (ie, non-causal) finding in a further 346 (4.2%). Clinical documentation of VHD before death was highly specific but relatively insensitive for postmortem identification of VHD as the principal (specificity 96.8%; 95% CI 96.4% to 97.2%; sensitivity 69.7%, 95% CI 62.1% to 76.6%) or any (specificity 98.1%; 95% CI 97.8% to 98.4%; sensitivity 68.4%, 95% CI 63.1% to 73.4%) cause of death. VHD (principally aortic stenosis, endocarditis and rheumatic heart disease) was newly noted at postmortem and listed as a cause of death in 142 individuals (1.7%). Clinical information recorded premortem is highly specific but relatively insensitive for the cause of death established at autopsy. Population-based mortality statistics that depend on premortem clinical information are likely to routinely underestimate the mortality burden of VHD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

75 FR 65636 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee...

Science.gov (United States)

2010-10-26

... Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National... Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Standards... Strategic Plan, and in accordance with policies developed by the HIT Policy Committee. Date and Time: The...

75 FR 57027 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee...

Science.gov (United States)

2010-09-17

... Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National... Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Standards... Strategic Plan, and in accordance with policies developed by the HIT Policy Committee. Date and Time: The...

75 FR 42090 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee...

Science.gov (United States)

2010-07-20

... Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National... Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Standards... Strategic Plan, and in accordance with policies developed by the HIT Policy Committee. Date and Time: The...

Diagnostic utility of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) and its combination with the Addenbrooke's Cognitive Examination-Revised (ACE-R) in a memory clinic-based population.

Science.gov (United States)

Hancock, P; Larner, A J

2009-06-01

The study aimed to assess the clinical utility of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) in patients referred to memory clinics, alone and in combination with the Addenbrooke's Cognitive Examination-Revised (ACE-R) and the Mini-mental State Examination (MMSE). This pragmatic prospective study was based on consecutive referrals attending with an informant (n = 144) to two memory clinics over a 12-month period. Patients were diagnosed using standard clinical diagnostic criteria for dementia (DSM-IV) as gold standard (dementia prevalence = 59%). The IQCODE was administered to informants, and the ACE-R and/or MMSE to most patients. The IQCODE proved acceptable to informants, and was quick and easy to use. Using traditional parameters of diagnostic utility (sensitivity, specificity, positive predictive value, likelihood ratios), the performance of the IQCODE at optimal test accuracy was highly sensitive (0.86) for the diagnosis of dementia but specificity was poor (0.39) with suboptimal positive predictive value (0.67) and small or unimportant likelihood ratios. Overall diagnostic accuracy based on area under the receiver operating characteristic (ROC) curve was 0.71. Combining the IQCODE with either ACE-R or MMSE greatly improved accuracy, specificity and positive predictive value when the tests were used in series, but not when used in parallel. In a memory clinic based population, the IQCODE proved sensitive for the diagnosis of dementia but overall diagnostic accuracy was suboptimal. Combining the IQCODE in series with the ACE-R or MMSE greatly improved diagnostic utility.

Possibilities and Implications of Using the ICF and Other Vocabulary Standards in Electronic Health Records.

Science.gov (United States)

Vreeman, Daniel J; Richoz, Christophe

2015-12-01

There is now widespread recognition of the powerful potential of electronic health record (EHR) systems to improve the health-care delivery system. The benefits of EHRs grow even larger when the health data within their purview are seamlessly shared, aggregated and processed across different providers, settings and institutions. Yet, the plethora of idiosyncratic conventions for identifying the same clinical content in different information systems is a fundamental barrier to fully leveraging the potential of EHRs. Only by adopting vocabulary standards that provide the lingua franca across these local dialects can computers efficiently move, aggregate and use health data for decision support, outcomes management, quality reporting, research and many other purposes. In this regard, the International Classification of Functioning, Disability, and Health (ICF) is an important standard for physiotherapists because it provides a framework and standard language for describing health and health-related states. However, physiotherapists and other health-care professionals capture a wide range of data such as patient histories, clinical findings, tests and measurements, procedures, and so on, for which other vocabulary standards such as Logical Observation Identifiers Names and Codes and Systematized Nomenclature Of Medicine Clinical Terms are crucial for interoperable communication between different electronic systems. In this paper, we describe how the ICF and other internationally accepted vocabulary standards could advance physiotherapy practise and research by enabling data sharing and reuse by EHRs. We highlight how these different vocabulary standards fit together within a comprehensive record system, and how EHRs can make use of them, with a particular focus on enhancing decision-making. By incorporating the ICF and other internationally accepted vocabulary standards into our clinical information systems, physiotherapists will be able to leverage the potent

A Proposed Clinical Decision Support Architecture Capable of Supporting Whole Genome Sequence Information

Directory of Open Access Journals (Sweden)

Brandon M. Welch

2014-04-01

Full Text Available Whole genome sequence (WGS information may soon be widely available to help clinicians personalize the care and treatment of patients. However, considerable barriers exist, which may hinder the effective utilization of WGS information in a routine clinical care setting. Clinical decision support (CDS offers a potential solution to overcome such barriers and to facilitate the effective use of WGS information in the clinic. However, genomic information is complex and will require significant considerations when developing CDS capabilities. As such, this manuscript lays out a conceptual framework for a CDS architecture designed to deliver WGS-guided CDS within the clinical workflow. To handle the complexity and breadth of WGS information, the proposed CDS framework leverages service-oriented capabilities and orchestrates the interaction of several independently-managed components. These independently-managed components include the genome variant knowledge base, the genome database, the CDS knowledge base, a CDS controller and the electronic health record (EHR. A key design feature is that genome data can be stored separately from the EHR. This paper describes in detail: (1 each component of the architecture; (2 the interaction of the components; and (3 how the architecture attempts to overcome the challenges associated with WGS information. We believe that service-oriented CDS capabilities will be essential to using WGS information for personalized medicine.

Radiotherapy for pediatric brain tumors: Standard of care, current clinical trials, and new directions

International Nuclear Information System (INIS)

Kun, Larry E.

1996-01-01

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

A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research.

Science.gov (United States)

Cofiel, Luciana; Zammar, Guilherme R; Zaveri, Amrapali J; Shah, Jatin Y; Carvalho, Elias; Nahm, Meredith; Kesselring, Gustavo; Pietrobon, Ricardo

2010-12-31

Industry standards provide rigorous descriptions of required data presentation, with the aim of ensuring compatibility across different clinical studies. However despite their crucial importance, these standards are often not used as expected in the development of clinical research. The reasons for this lack of compliance could be related to the high cost and time-intensive nature of the process of data standards implementation. The objective of this study was to evaluate the value of the extra time and cost required for different levels of data standardisation and the likelihood of researchers to comply with these levels. Since we believe that the cost and time necessary for the implementation of data standards can change over time, System Dynamics (SD) analysis was used to investigate how these variables interact and influence the adoption of data standards by clinical researchers. Three levels of data standards implementation were defined through focus group discussion involving four clinical research investigators. Ten Brazilian and eighteen American investigators responded to an online questionnaire which presented possible standards implementation scenarios, with respondents asked to choose one of two options available in each scenario. A random effects ordered probit model was used to estimate the effect of cost and time on investigators' willingness to adhere to data standards. The SD model was used to demonstrate the relationship between degrees of data standardisation and subsequent variation in cost and time required to start the associated study. A preference for low cost and rapid implementation times was observed, with investigators more likely to incur costs than to accept a time delay in project start-up. SD analysis indicated that although initially extra time and cost are necessary for clinical study standardisation, there is a decrease in both over time. Future studies should explore ways of creating mechanisms which decrease the time and cost

A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research

Science.gov (United States)

2010-01-01

Background Industry standards provide rigorous descriptions of required data presentation, with the aim of ensuring compatibility across different clinical studies. However despite their crucial importance, these standards are often not used as expected in the development of clinical research. The reasons for this lack of compliance could be related to the high cost and time-intensive nature of the process of data standards implementation. The objective of this study was to evaluate the value of the extra time and cost required for different levels of data standardisation and the likelihood of researchers to comply with these levels. Since we believe that the cost and time necessary for the implementation of data standards can change over time, System Dynamics (SD) analysis was used to investigate how these variables interact and influence the adoption of data standards by clinical researchers. Methods Three levels of data standards implementation were defined through focus group discussion involving four clinical research investigators. Ten Brazilian and eighteen American investigators responded to an online questionnaire which presented possible standards implementation scenarios, with respondents asked to choose one of two options available in each scenario. A random effects ordered probit model was used to estimate the effect of cost and time on investigators' willingness to adhere to data standards. The SD model was used to demonstrate the relationship between degrees of data standardisation and subsequent variation in cost and time required to start the associated study. Results A preference for low cost and rapid implementation times was observed, with investigators more likely to incur costs than to accept a time delay in project start-up. SD analysis indicated that although initially extra time and cost are necessary for clinical study standardisation, there is a decrease in both over time. Conclusions Future studies should explore ways of creating

Preliminary Safety Information Document for the Standard MHTGR. Volume 1, (includes latest Amendments)

Energy Technology Data Exchange (ETDEWEB)

None

1986-01-01

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.

The influence of standards and clinical guidelines on prosthetic and orthotic service quality: a scoping review.

Science.gov (United States)

Sadeghi-Demneh, Ebrahim; Forghany, Saeed; Onmanee, Pornsuree; Trinler, Ursula; Dillon, Michael P; Baker, Richard

2017-06-20

Standards and guidelines are an integral part of prosthetic and orthotic service delivery in the developed world underpinned by an assumption that they lead to improved services. Implementing them has a cost, however, and that cost needs to be justified, particularly in resource-limited environments. This scoping review thus asks the question, "What is the evidence of the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics?" A structured search of three electronic databases (Medline, Scopus and Web of Science) followed by manual searching of title, abstract and full text, yielded 29 articles. Four categories of papers were identified: Descriptions and Commentaries (17 papers), Guideline Development (7), Guideline Testing (2) and Standards implementation (3). No articles were explicitly designed to assess the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics. Studies tended to be commentaries on or descriptions of guideline development, testing or implementation of standards. The literature is not sufficiently well developed to warrant the cost and effort of a systematic review. Future primary research should seek to demonstrate whether and how guidelines and standards improve the outcomes for people that require prostheses, orthoses and other assistive devices. Implications for Rehabilitation International Standards and Clinical Guidelines are now an integral part of clinical service provision in prosthetics and orthotics in the developed world. Complying with standards and guidelines has a cost and, particularly in resource-limited environments, it should be possible to justify this in terms of the resulting benefits. This scoping review concludes that there have been no previous studies designed to directly quantify the effects of implementing standards and guidelines on service delivery.

DOE technical standards list: Department of Energy standards index

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-05-01

This Department of Energy (DOE) technical standards list (TSL) has been prepared by the Office of Nuclear Safety Policy and Standards (EH-31) on the basis of currently available technical information. Periodic updates of this TSL will be issued as additional information is received on standardization documents being issued, adopted, or canceled by DOE. This document was prepared for use by personnel involved in the selection and use of DOE technical standards and other Government and non-Government standards. This TSL provides listings of current DOE technical standards, non-Government standards that have been adopted by DOE, other standards-related documents in which DOE has a recorded interest, and canceled DOE technical standards. Information on new DOE technical standards projects, technical standards released for coordination, recently published DOE technical standards, and activities of non-Government standards bodies that may be of interest to DOE is published monthly in Standards Actions.

78 FR 16538 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Standard on...

Science.gov (United States)

2013-03-15

... (OSHA) sponsored information collection request (ICR) titled, ``Standard on 4,4'-Methylenedianiline in... this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA...'-Methylenedianiline (MDA) in Construction protects workers from adverse health effects associated with occupational...

The regulation of informed consent to participation in clinical ...

African Journals Online (AJOL)

participation in clinical research by mentally ill persons – the discussion on informed consent .... usually lay persons without scientific and medical knowledge. It is .... is not defined by the Mental Health Care Act; nor is it stated anywhere in the ...

Discharge communication from inpatient care: an audit of written medical discharge summary procedure against the new National Health Service Standard for clinical handover.

Science.gov (United States)

Reid, Daniel Brooks; Parsons, Shaun R; Gill, Stephen D; Hughes, Andrew J

2015-04-01

To audit written medical discharge summary procedure and practice against Standard Six (clinical handover) of the Australian National Safety and Quality Health Service Standards at a major regional Victorian health service. Department heads were invited to complete a questionnaire about departmental discharge summary practices. Twenty-seven (82%) department heads completed the questionnaire. Seven (26%) departments had a documented discharge summary procedure. Fourteen (52%) departments monitored discharge summary completion and 13 (48%) departments monitored the timeliness of completion. Seven (26%) departments informed the patient of the content of the discharge summary and six (22%) departments provided the patient with a copy. Seven (26%) departments provided training for staff members on how to complete discharge summaries. Completing discharge summaries was usually delegated to the medical intern. The introduction of the National Service Standards prompted an organisation-wide audit of discharge summary practices against the external criterion. There was substantial variation in the organisation's practices. The Standards and the current audit results highlight an opportunity for the organisation to enhance and standardise discharge summary practices and improve communication with general practice.

[Design and implementation of medical instrument standard information retrieval system based on APS.NET].

Science.gov (United States)

Yu, Kaijun

2010-07-01

This paper Analys the design goals of Medical Instrumentation standard information retrieval system. Based on the B /S structure,we established a medical instrumentation standard retrieval system with ASP.NET C # programming language, IIS f Web server, SQL Server 2000 database, in the. NET environment. The paper also Introduces the system structure, retrieval system modules, system development environment and detailed design of the system.

Quantitative metrics for evaluating the phased roll-out of clinical information systems.

Science.gov (United States)

Wong, David; Wu, Nicolas; Watkinson, Peter

2017-09-01

We introduce a novel quantitative approach for evaluating the order of roll-out during phased introduction of clinical information systems. Such roll-outs are associated with unavoidable risk due to patients transferring between clinical areas using both the old and new systems. We proposed a simple graphical model of patient flow through a hospital. Using a simple instance of the model, we showed how a roll-out order can be generated by minimising the flow of patients from the new system to the old system. The model was applied to admission and discharge data acquired from 37,080 patient journeys at the Churchill Hospital, Oxford between April 2013 and April 2014. The resulting order was evaluated empirically and produced acceptable orders. The development of data-driven approaches to clinical Information system roll-out provides insights that may not necessarily be ascertained through clinical judgment alone. Such methods could make a significant contribution to the smooth running of an organisation during the roll-out of a potentially disruptive technology. Unlike previous approaches, which are based on clinical opinion, the approach described here quantitatively assesses the appropriateness of competing roll-out strategies. The data-driven approach was shown to produce strategies that matched clinical intuition and provides a flexible framework that may be used to plan and monitor Clinical Information System roll-out. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

Building gold standard corpora for medical natural language processing tasks.

Science.gov (United States)

Deleger, Louise; Li, Qi; Lingren, Todd; Kaiser, Megan; Molnar, Katalin; Stoutenborough, Laura; Kouril, Michal; Marsolo, Keith; Solti, Imre

2012-01-01

We present the construction of three annotated corpora to serve as gold standards for medical natural language processing (NLP) tasks. Clinical notes from the medical record, clinical trial announcements, and FDA drug labels are annotated. We report high inter-annotator agreements (overall F-measures between 0.8467 and 0.9176) for the annotation of Personal Health Information (PHI) elements for a de-identification task and of medications, diseases/disorders, and signs/symptoms for information extraction (IE) task. The annotated corpora of clinical trials and FDA labels will be publicly released and to facilitate translational NLP tasks that require cross-corpora interoperability (e.g. clinical trial eligibility screening) their annotation schemas are aligned with a large scale, NIH-funded clinical text annotation project.

Development of the standard classification system of technical information in the field of RI-biomics and its application to the web system

International Nuclear Information System (INIS)

Jang, Sol Ah; Kim, Joo Yeon; Park, Tai Jin

2014-01-01

RI-Biomics is a new concept that combines radioisotopes (RI) and Biomics. For efficient collection of information, establishment of database for technical information system and its application to the system, there is an increasing need for constructing the standard classification system of technical information by its systematical classification. In this paper, we have summarized the development process of the standard classification system of technical information in the field of RI-Biomics and its application to the system. Constructing the draft version for the standard classification system of technical information was based on that standard classification one in national science and technology in Korea. The final classification system was then derived through the reconstruction and the feedback process based on the consultation from the 7 experts. These results were applied to the database of technical information system after transforming as standard code. Thus, the standard classification system were composed of 5 large classifications and 20 small classifications, and those classification are expected to establish the foundation of information system by achieving the circular structure of collection-analysis-application of information

Fine-grained information extraction from German transthoracic echocardiography reports.

Science.gov (United States)

Toepfer, Martin; Corovic, Hamo; Fette, Georg; Klügl, Peter; Störk, Stefan; Puppe, Frank

2015-11-12

Information extraction techniques that get structured representations out of unstructured data make a large amount of clinically relevant information about patients accessible for semantic applications. These methods typically rely on standardized terminologies that guide this process. Many languages and clinical domains, however, lack appropriate resources and tools, as well as evaluations of their applications, especially if detailed conceptualizations of the domain are required. For instance, German transthoracic echocardiography reports have not been targeted sufficiently before, despite of their importance for clinical trials. This work therefore aimed at development and evaluation of an information extraction component with a fine-grained terminology that enables to recognize almost all relevant information stated in German transthoracic echocardiography reports at the University Hospital of Würzburg. A domain expert validated and iteratively refined an automatically inferred base terminology. The terminology was used by an ontology-driven information extraction system that outputs attribute value pairs. The final component has been mapped to the central elements of a standardized terminology, and it has been evaluated according to documents with different layouts. The final system achieved state-of-the-art precision (micro average.996) and recall (micro average.961) on 100 test documents that represent more than 90 % of all reports. In particular, principal aspects as defined in a standardized external terminology were recognized with f 1=.989 (micro average) and f 1=.963 (macro average). As a result of keyword matching and restraint concept extraction, the system obtained high precision also on unstructured or exceptionally short documents, and documents with uncommon layout. The developed terminology and the proposed information extraction system allow to extract fine-grained information from German semi-structured transthoracic echocardiography reports

75 FR 51818 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee's...

Science.gov (United States)

2010-08-23

... Technology; HIT Standards Committee's Workgroup Meetings; Notice of Meetings AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice of meetings. This notice announces... for Health Information Technology (ONC). The meetings will be open to the public via dial-in access...

75 FR 65486 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee's...

Science.gov (United States)

2010-10-25

... Technology; HIT Standards Committee's Workgroup Meetings; Notice of Meetings AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice of meetings. This notice announces... for Health Information Technology (ONC). The meetings will be open to the public via dial-in access...

75 FR 57025 - Office of the National Coordinator for Health Information Technology; HIT Standards Committee's...