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.

Sacroiliac Pain: A Clinical Approach for the Neurosurgeon

Science.gov (United States)

Moscote-Salazar, Luis Rafael; Alvis-Miranda, Hernando Raphael; Joaquim, Andrei Fernandes; Amaya-Quintero, Jessica; Padilla-Zambrano, Huber S.; Agrawal, Amit

2017-01-01

Pain originating from sacroiliac joint may also cause pain in the lumbar and gluteal region in 15% of the population. The clinical manifestation represents a public health problem due to the great implications on the quality of life and health-related costs. However, this is a diagnosis that is usually ignored in the general clinical practice; probably because of the unknown etiology, making harder to rule out the potential etiologies of this pathology, or maybe because the clinical criteria that support this pathology are unknown. By describing several diagnostic techniques, many authors have studied the prevalence of this pathology, finding more positive data than expected; coming to the conclusion that even though there is no diagnostic gold standard yet, an important amount of cases might be detected by properly applying several tests at the physical examination. Thus, it is necessary to have knowledge of the physiopathology and clinical presentation so that diagnosis can be made to those patients that manifest this problem. We present a clinical approach for the neurosurgeon. PMID:29204025

Sacroiliac pain: A clinical approach for the neurosurgeon

Directory of Open Access Journals (Sweden)

Luis Rafael Moscote-Salazar

2017-01-01

Full Text Available Pain originating from sacroiliac joint may also cause pain in the lumbar and gluteal region in 15% of the population. The clinical manifestation represents a public health problem due to the great implications on the quality of life and health-related costs. However, this is a diagnosis that is usually ignored in the general clinical practice; probably because of the unknown etiology, making harder to rule out the potential etiologies of this pathology, or maybe because the clinical criteria that support this pathology are unknown. By describing several diagnostic techniques, many authors have studied the prevalence of this pathology, finding more positive data than expected; coming to the conclusion that even though there is no diagnostic gold standard yet, an important amount of cases might be detected by properly applying several tests at the physical examination. Thus, it is necessary to have knowledge of the physiopathology and clinical presentation so that diagnosis can be made to those patients that manifest this problem. We present a clinical approach for the neurosurgeon.

Quality assurance in clinical trials : a multi-disciplinary approach

International Nuclear Information System (INIS)

Cornes, D.

2001-01-01

Full text: Multi-disciplinary groups, such as medical physicists and radiation therapists, which work effectively together, can ensure continued improvements in radiation therapy quality. The same is also true for clinical trials, which have the added complication of requiring multi-institutional participation to collate sufficient data to effectively assess treatment benefits. It can be difficult to manage quality across all aspects of a multi-disciplinary and multi-institutional trial. A planned system of quality assurance is necessary to provide support for participating centres and facilitate a collaborative approach. To ensure protocol compliance a good relationship between the clinical trial group and treatment centre is idea with definition of mutual goals and objectives before and during the trial, and ongoing consultation and feedback throughout the trial process. To ensure good quality data and maximise the validity of results the study protocol must be strictly adhered to. Because of the need for meticulous attention to detail, both in treatment delivery and standards of documentation, clinical trials are often seen to further complicate the process of delivery of radiation therapy treatment. The Declaration of Helsinki and Good Clinical Practise Guidelines (adopted in May 1996, ICH) provide 'international ethical and scientific standards for designing, conducting, recording and reporting clinical research' and multi-disciplinary groups in each participating centre should also adhere to these guidelines. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

Fault estimation - A standard problem approach

DEFF Research Database (Denmark)

Stoustrup, J.; Niemann, Hans Henrik

2002-01-01

This paper presents a range of optimization based approaches to fault diagnosis. A variety of fault diagnosis problems are reformulated in the so-called standard problem set-up introduced in the literature on robust control. Once the standard problem formulations are given, the fault diagnosis...... problems can be solved by standard optimization techniques. The proposed methods include (1) fault diagnosis (fault estimation, (FE)) for systems with model uncertainties; FE for systems with parametric faults, and FE for a class of nonlinear systems. Copyright...

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.

Standardized Approach to Quantitatively Measure Residual Limb Skin Health in Individuals with Lower Limb Amputation.

Science.gov (United States)

Rink, Cameron L; Wernke, Matthew M; Powell, Heather M; Tornero, Mark; Gnyawali, Surya C; Schroeder, Ryan M; Kim, Jayne Y; Denune, Jeffrey A; Albury, Alexander W; Gordillo, Gayle M; Colvin, James M; Sen, Chandan K

2017-07-01

Objective: (1) Develop a standardized approach to quantitatively measure residual limb skin health. (2) Report reference residual limb skin health values in people with transtibial and transfemoral amputation. Approach: Residual limb health outcomes in individuals with transtibial ( n  = 5) and transfemoral ( n  = 5) amputation were compared to able-limb controls ( n  = 4) using noninvasive imaging (hyperspectral imaging and laser speckle flowmetry) and probe-based approaches (laser doppler flowmetry, transcutaneous oxygen, transepidermal water loss, surface electrical capacitance). Results: A standardized methodology that employs noninvasive imaging and probe-based approaches to measure residual limb skin health are described. Compared to able-limb controls, individuals with transtibial and transfemoral amputation have significantly lower transcutaneous oxygen tension, higher transepidermal water loss, and higher surface electrical capacitance in the residual limb. Innovation: Residual limb health as a critical component of prosthesis rehabilitation for individuals with lower limb amputation is understudied in part due to a lack of clinical measures. Here, we present a standardized approach to measure residual limb health in people with transtibial and transfemoral amputation. Conclusion: Technology advances in noninvasive imaging and probe-based measures are leveraged to develop a standardized approach to quantitatively measure residual limb health in individuals with lower limb loss. Compared to able-limb controls, resting residual limb physiology in people that have had transfemoral or transtibial amputation is characterized by lower transcutaneous oxygen tension and poorer skin barrier function.

One-Tube-Only Standardized Site-Directed Mutagenesis: An Alternative Approach to Generate Amino Acid Substitution Collections

NARCIS (Netherlands)

Mingo, J.; Erramuzpe, A.; Luna, S.; Aurtenetxe, O.; Amo, L.; Diez, I.; Schepens, J.T.G.; Hendriks, W.J.A.J.; Cortes, J.M.; Pulido, R.

2016-01-01

Site-directed mutagenesis (SDM) is a powerful tool to create defined collections of protein variants for experimental and clinical purposes, but effectiveness is compromised when a large number of mutations is required. We present here a one-tube-only standardized SDM approach that generates

A Novel Approach to Simulation-Based Education for Veterinary Medical Communication Training Over Eight Consecutive Pre-Clinical Quarters.

Science.gov (United States)

Englar, Ryane E

Experiential learning through the use of standardized patients (SPs) is the primary way by which human medical schools teach clinical communication. The profession of veterinary medicine has followed suit in response to new graduates' and their employers' concerns that veterinary interpersonal skills are weak and unsatisfactory. As a result, standardized clients (SCs) are increasingly relied upon as invaluable teaching tools within veterinary curricula to advance relationship-centered care in the context of a clinical scenario. However, there is little to no uniformity in the approach that various colleges of veterinary medicine take when designing simulation-based education (SBE). A further complication is that programs with pre-conceived curricula must now make room for training in clinical communication. Curricular time constraints challenge veterinary colleges to individually decide how best to utilize SCs in what time is available. Because it is a new program, Midwestern University College of Veterinary Medicine (MWU CVM) has had the flexibility and the freedom to prioritize an innovative approach to SBE. The author discusses the SBE that is currently underway at MWU CVM, which incorporates 27 standardized client encounters over eight consecutive pre-clinical quarters. Prior to entering clinical rotations, MWU CVM students are exposed to a variety of simulation formats, species, clients, settings, presenting complaints, and communication tasks. These represent key learning opportunities for students to practice clinical communication, develop self-awareness, and strategize their approach to future clinical experiences.

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.

Nuclear security standard: Argentina approach

International Nuclear Information System (INIS)

Bonet Duran, Stella M.; Rodriguez, Carlos E.; Menossi, Sergio A.; Serdeiro, Nelida H.

2007-01-01

Argentina has a comprehensive regulatory system designed to assure the security and safety of radioactive sources, which has been in place for more than fifty years. In 1989 the Radiation Protection and Nuclear Safety branch of the National Atomic Energy Commission created the 'Council of Physical Protection of Nuclear Materials and Installations' (CAPFMIN). This Council published in 1992 a Physical Protection Standard based on a deep and careful analysis of INFCIRC 225/Rev.2 including topics like 'sabotage scenario'. Since then, the world's scenario has changed, and some concepts like 'design basis threat', 'detection, delay and response', 'performance approach and prescriptive approach', have been applied to the design of physical protection systems in facilities other than nuclear installations. In Argentina, radioactive sources are widely used in medical and industrial applications with more than 1,600 facilities controlled by the Nuclear Regulatory Authority (in spanish ARN). During 2005, measures like 'access control', 'timely detection of intruder', 'background checks', and 'security plan', were required by ARN for implementation in facilities with radioactive sources. To 'close the cycle' the next step is to produce a regulatory standard based on the operational experience acquired during 2005. ARN has developed a set of criteria for including them in a new standard on security of radioactive materials. Besides, a specific Regulatory Guide is being prepared to help licensees of facilities in design a security system and to fulfill the 'Design of Security System Questionnaire'. The present paper describes the proposed Standard on Security of Radioactive Sources and the draft of the Nuclear Security Regulatory Guidance, based on our regulatory experience and the latest international recommendations. (author)

Natural language processing systems for capturing and standardizing unstructured clinical information: A systematic review.

Science.gov (United States)

Kreimeyer, Kory; Foster, Matthew; Pandey, Abhishek; Arya, Nina; Halford, Gwendolyn; Jones, Sandra F; Forshee, Richard; Walderhaug, Mark; Botsis, Taxiarchis

2017-09-01

We followed a systematic approach based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses to identify existing clinical natural language processing (NLP) systems that generate structured information from unstructured free text. Seven literature databases were searched with a query combining the concepts of natural language processing and structured data capture. Two reviewers screened all records for relevance during two screening phases, and information about clinical NLP systems was collected from the final set of papers. A total of 7149 records (after removing duplicates) were retrieved and screened, and 86 were determined to fit the review criteria. These papers contained information about 71 different clinical NLP systems, which were then analyzed. The NLP systems address a wide variety of important clinical and research tasks. Certain tasks are well addressed by the existing systems, while others remain as open challenges that only a small number of systems attempt, such as extraction of temporal information or normalization of concepts to standard terminologies. This review has identified many NLP systems capable of processing clinical free text and generating structured output, and the information collected and evaluated here will be important for prioritizing development of new approaches for clinical NLP. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

A model-driven approach for representing clinical archetypes for Semantic Web environments.

Science.gov (United States)

Martínez-Costa, Catalina; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás; Maldonado, José Alberto

2009-02-01

The life-long clinical information of any person supported by electronic means configures his Electronic Health Record (EHR). This information is usually distributed among several independent and heterogeneous systems that may be syntactically or semantically incompatible. There are currently different standards for representing and exchanging EHR information among different systems. In advanced EHR approaches, clinical information is represented by means of archetypes. Most of these approaches use the Archetype Definition Language (ADL) to specify archetypes. However, ADL has some drawbacks when attempting to perform semantic activities in Semantic Web environments. In this work, Semantic Web technologies are used to specify clinical archetypes for advanced EHR architectures. The advantages of using the Ontology Web Language (OWL) instead of ADL are described and discussed in this work. Moreover, a solution combining Semantic Web and Model-driven Engineering technologies is proposed to transform ADL into OWL for the CEN EN13606 EHR architecture.

[Possible relation between clinical guidelines and legal standard of medicine].

Science.gov (United States)

Furukawa, Toshiharu; Kitagawa, Yuko

2010-10-01

Legal standard of medicine is not equal across the all kinds of medical institutions. Each medical institution is required its respective standard of medicine in which its doctors are expected to have studied medical informations, which have been spread among medical institutions with similar characteristics. Therefore, in principle, clinical guidelines for the treatment of a disease formed by public committees do not directly become the medical standards of respective disease treatment. However, doctors would be legally required to practice medicine with reference to the clinical guidelines because medical informations, mediated by internet or many kinds of media, have been spread very fast to all medical institutions these days. Moreover, doctors would be required to inform their patients of non-standardized new treatments, even if such treatments are not listed in clinical guidelines in case patients have special concern about new treat-

Integrated monitoring: Setting new standards for the next decade of clinical trial practice

Directory of Open Access Journals (Sweden)

Kamala Rai

2011-01-01

Full Text Available The new age clinical research professional is now geared toward an "integrated monitoring" approach. A number of critical activities at the site level and at the sponsor′s organization need convergence to harness rich dividends in early study start and quick close of the study. The field monitor needs full integration to ensure standard of care, train the site in protocol, select the right site, ensure regulatory support, ensure excellent project management skills, coach, support the logistics team, manage the vendor, ensure good documentation practices, develop patient recruitment and retention, lean the applicable process, as well as ensure effective site management amongst the myriad activities assigned toward developing the drug in the clinic.

Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials.

Science.gov (United States)

Van Heertum, Ronald L; Scarimbolo, Robert; Ford, Robert; Berdougo, Eli; O'Neal, Michael

2015-01-01

In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes.

Combining clinical judgment with guidelines for the management of type 2 diabetes: overall standards of comprehensive care.

Science.gov (United States)

Yacoub, Tamer G

2014-05-01

The rising toll of type 2 diabetes mellitus (T2DM) on patients and society has resulted in a wide variety of guidelines and therapies to address the need to combat this trend. Given the heterogeneity of T2DM and the different responses patients have to therapies, as well as the continued need for patients to institute lifestyle changes, guidelines published by the American Diabetes Association/European Association for the Study of Diabetes and the American Association of Clinical Endocrinologists/American College of Endocrinology have in recent years increased the focus on personalized and patient-centered care. How to best assimilate the overall standards of care for T2DM into clinical practice remains a challenge. The 4 pillars of effective diabetes management are a unifying framework and approach to clinical practice that can be integrated with the latest diabetes guidelines. These 4 pillars are lifestyle modifications involving (1) diet, (2) exercise, (3) a system to monitor preprandial and postprandial blood glucose and glycated hemoglobin levels, and (4) pharmacologic intervention when required. This article reviews the overall standards of care for T2DM, focusing on the first 3 nonpharmacologic pillars, and provides suggestions for integrating this approach with the current American Diabetes Association and American Association of Clinical Endocrinologists/American College of Endocrinology guidelines. Barriers to effective implementation of exercise programs, diets, and monitoring of blood glucose levels are discussed along with clinical strategies to overcome these barriers and achieve effective glycemic control and lifestyle changes for patients with T2DM. Personalized approaches to the management of T2DM are also reviewed.

International, multi-center standardization of acute graft-versus-host disease clinical data collection: a report from the MAGIC consortium

Science.gov (United States)

Harris, Andrew C.; Young, Rachel; Devine, Steven; Hogan, William J.; Ayuk, Francis; Bunworasate, Udomsak; Chanswangphuwana, Chantiya; Efebera, Yvonne A.; Holler, Ernst; Litzow, Mark; Ordemann, Rainer; Qayed, Muna; Renteria, Anne S.; Reshef, Ran; Wölfl, Matthias; Chen, Yi-Bin; Goldstein, Steven; Jagasia, Madan; Locatelli, Franco; Mielke, Stephan; Porter, David; Schechter, Tal; Shekhovtsova, Zhanna; Ferrara, James L.M.; Levine, John E.

2015-01-01

Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and non-relapse mortality following allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed upon by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multi-center clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance was following discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture which may improve the reproducibility of GVHD clinical trials after further prospective validation. PMID:26386318

The standardized surgical approach improves outcome of gallbladder cancer

Directory of Open Access Journals (Sweden)

Igna Dorian

2007-05-01

Full Text Available Abstract Background The objective of this study was to examine the extent of surgical procedures, pathological findings, complications and outcome of patients treated in the last 12 years for gallbladder cancer. Methods The impact of a standardized more aggressive approach compared with historical controls of our center with an individual approach was examined. Of 53 patients, 21 underwent resection for cure and 32 for palliation. Results Overall hospital mortality was 9% and procedure related mortality was 4%. The standardized approach in UICC stage IIa, IIb and III led to a significantly improved outcome compared to patients with an individual approach (Median survival: 14 vs. 7 months, mean+/-SEM: 26+/-7 vs. 17+/-5 months, p = 0.014. The main differences between the standardized and the individual approach were anatomical vs. atypical liver resection, performance of systematic lymph dissection of the hepaticoduodenal ligament and the resection of the common bile duct. Conclusion Anatomical liver resection, proof for bile duct infiltration and, in case of tumor invasion, radical resection and lymph dissection of the hepaticoduodenal ligament are essential to improve outcome of locally advanced gallbladder cancer.

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

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

Risk approaches in setting radiation standards

International Nuclear Information System (INIS)

Whipple, C.

1984-01-01

This paper discusses efforts to increase the similarity of risk regulation approaches for radiation and chemical carcinogens. The risk assessment process in both cases involves the same controversy over the extrapolation from high to low doses and dose rates, and in both cases the boundaries between science and policy in risk assessment are indistinct. Three basic considerations are presented to approach policy questions: the economic efficiency of the regulatory approach, the degree of residual risk, and the technical opportunities for risk control. It is the author's opinion that if an agency can show that its standard-setting policies are consistent with those which have achieved political and judicial acceptance in other contexts, the greater the predictability of the regulatory process and the stability of this process

Headache after traumatic brain injury: a national survey of clinical practices and treatment approaches.

Science.gov (United States)

Brown, Allen W; Watanabe, Thomas K; Hoffman, Jeanne M; Bell, Kathleen R; Lucas, Sylvia; Dikmen, Sureyya

2015-01-01

Individuals with headache after traumatic brain injury (TBI) receive care in a wide variety of clinical locations by physicians trained in multiple specialties. To understand current practice patterns and perceptions of treatment issues among clinicians managing headache after TBI. National survey of current clinical practice using a 20-item questionnaire developed by the authors. Survey respondents were members of the Central Nervous System Council list survey of the American Academy of Physical Medicine and Rehabilitation (N = 1782) and the American Headache Society membership (N = 1260). The survey was sent electronically to potential participants and was followed by 2 biweekly reminders. The survey queried the physicians' clinical setting; their use of headache classification systems, headache diaries, checklists, and diagnostic procedures; the pharmacologic and nonpharmacologic treatments prescribed; and headache chronicity and associated symptoms and disorders among their patients with TBI. Completed surveys were received from 193 respondents. The use of standardized classification systems and checklists was commonly reported. Respondents used nonpharmacologic and pharmacologic treatment approaches with similar frequency and modest perceived success rates. A high frequency of headache-associated new sleep and mood disorders was reported. When response differences occurred between practice settings, they reflected a focus on headache diagnosis, classification, and pharmacologic treatment among neurology and specialty headache clinics, whereas a nonpharmacologic approach to management among TBI specialty and general rehabilitation clinicians was more commonly reported. Management strategies for treating headache after TBI vary widely among general and specialty clinical practices. This suggests that additional research is needed that would lead to an increase in the use of established headache classification and the development of standardized management

Pediatric Dentistry: A Clinical Approach, 3rd Edition

DEFF Research Database (Denmark)

Pediatric Dentistry: A Clinical Approach, Third Edition provides a uniquely clear, comprehensive, and clinical approach to the dental treatment of children and adolescents. •Offers systematic coverage of all clinical, scientific and social topics relating to pediatric dentistry •Thoroughly revised...

Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust.

Science.gov (United States)

Bamford, K B; Wood, S; Shaw, R J

2005-02-01

Conducting gene therapy clinical trials with genetically modified organisms as the vectors presents unique safety and infection control issues. The area is governed by a range of legislation and guidelines, some unique to this field, as well as those pertinent to any area of clinical work. The relevant regulations covering gene therapy using genetically modified vectors are reviewed and illustrated with the approach taken by a large teaching hospital NHS Trust. Key elements were Trust-wide communication and involvement of staff in a pro-active approach to risk management, with specific emphasis on staff training and engagement, waste management, audit and record keeping. This process has led to the development of proposed standards for clinical trials involving genetically modified micro-organisms.

Integrated management system - management standards evolution and the IAEA new approach

International Nuclear Information System (INIS)

Oliveira, Dirceu Paulo de; Zouain, Desiree Moraes

2007-01-01

The management standards application began in military and nuclear areas towards the end of Second World War, when some westerns countries developed quality standards to improve their means to assess suppliers' conditions to assure their products conformance, which was increasingly complex and required a higher degree of reliability. Afterwards, the quality standards application was extended to the consumer market focused on consumers' requirements satisfaction. Coming along the society crescent concern about quality of life, other management standards were developed, such as those dealing with environmental and sustainable development, occupational health and safety, social accountability and so on. As a consequence, the management process became complex. The management system integrated form approach makes possible the compatibility of distinct and complementary interests from several functions and disciplines involved and supply the absence of the organizations' holistic approach. According to this integrated management approach, the Agency - 'International Atomic Energy Agency' (IAEA) - decided to review the structure of the 50-C-Q standard - 'Quality Assurance for Safety in Nuclear Power Plants and Other Nuclear Installations', from 1996, publishing in 2006 the new GS-R-3 standard - 'The Management System for Facilities and Activities - Safety Requirements'. This work presents a brief evolution of management standards and integrated management approach, showing the Agency's new vision concerning this issue with the GS-R-3 standard publication. (author)

"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.

Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

Science.gov (United States)

Dawson, Liza; Zwerski, Sheryl

2015-06-01

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

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

A statistical approach to traditional Vietnamese medical diagnoses standardization

International Nuclear Information System (INIS)

Nguyen Hoang Phuong; Nguyen Quang Hoa; Le Dinh Long

1990-12-01

In this paper the first results of the statistical approach for Cold-Heat diagnosis standardization as a first work in the ''eight rules diagnoses'' standardization of Traditional Vietnamese Medicine are briefly described. Some conclusions and suggestions for further work are given. 3 refs, 2 tabs

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.

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.

Approaches to Increasing Ethical Compliance in China with Drug Trial Standards of Practice

DEFF Research Database (Denmark)

Rosenberg, Jacob

2016-01-01

. With recent reports of scientific misconduct from China, there is an urgent need to find approaches to compel researchers to adhere to ethical research practices. This problem does not call for a simple solution, but if forces are joined with governmental regulations, education in ethics issues for medical......Zeng et al.'s Ethics Review highlights some of the challenges associated with clinical research in China. They found that only a minority of published clinical trials of anti-dementia drugs reported that they fulfilled the basic ethical principles as outlined in the Declaration of Helsinki...... researchers, and strong reinforcement by Chinese journal editors not to publish studies with these flaws, then research ethics and publication standards will probably improve. Other solutions to foster ethical practice of drug trials are discussed including Chinese initiatives directed at managing conflict...

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

The STEP standard as an approach for design and prototyping

OpenAIRE

Plantec , Alain; Ribaud , Vincent

1998-01-01

International audience; STEP is an ISO standard (ISO-10303) for the computer-interpretable representation and exchange of product data. Parts of STEP standardize conceptual structures and usage of information in generic or specific domains. The standardization process of these constructs is an evolutionary approach , which uses generated prototypes at different phases of the process. This paper presents a method for the building of prototype generators, inspired by this standardization proces...

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

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

A targeted metabolomics approach for clinical diagnosis of inborn errors of metabolism.

Science.gov (United States)

Jacob, Minnie; Malkawi, Abeer; Albast, Nour; Al Bougha, Salam; Lopata, Andreas; Dasouki, Majed; Abdel Rahman, Anas M

2018-09-26

Metabolome, the ultimate functional product of the genome, can be studied through identification and quantification of small molecules. The global metabolome influences the individual phenotype through clinical and environmental interventions. Metabolomics has become an integral part of clinical research and allowed for another dimension of better understanding of disease pathophysiology and mechanism. More than 95% of the clinical biochemistry laboratory routine workload is based on small molecular identification, which can potentially be analyzed through metabolomics. However, multiple challenges in clinical metabolomics impact the entire workflow and data quality, thus the biological interpretation needs to be standardized for a reproducible outcome. Herein, we introduce the establishment of a comprehensive targeted metabolomics method for a panel of 220 clinically relevant metabolites using Liquid chromatography-tandem mass spectrometry (LC-MS/MS) standardized for clinical research. The sensitivity, reproducibility and molecular stability of each targeted metabolite (amino acids, organic acids, acylcarnitines, sugars, bile acids, neurotransmitters, polyamines, and hormones) were assessed under multiple experimental conditions. The metabolic tissue distribution was determined in various rat organs. Furthermore, the method was validated in dry blood spot (DBS) samples collected from patients known to have various inborn errors of metabolism (IEMs). Using this approach, our panel appears to be sensitive and robust as it demonstrated differential and unique metabolic profiles in various rat tissues. Also, as a prospective screening method, this panel of diverse metabolites has the ability to identify patients with a wide range of IEMs who otherwise may need multiple, time-consuming and expensive biochemical assays causing a delay in clinical management. Copyright © 2018 Elsevier B.V. All rights reserved.

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

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

Enhancing Critical Thinking Via a Clinical Scholar Approach.

Science.gov (United States)

Simpson, Vicki; McComb, Sara A; Kirkpatrick, Jane M

2017-11-01

Safety, quality improvement, and a systems perspective are vital for nurses to provide quality evidence-based care. Responding to the call to prepare nurses with these perspectives, one school of nursing used a clinical scholar approach, enhanced by systems engineering to more intentionally develop the ability to clinically reason and apply evidence-based practice. A two-group, repeated-measures control trial was used to determine the effects of systems engineering content and support on nursing students' clinical judgment and critical thinking skills. Findings indicated this approach had a positive effects on student's clinical judgment and clinical reasoning skills. This approach helped students view health care issues from a broader perspective and use evidence to guide solution development, enhancing the focus on evidence-based practice, and quality improvement. Intentional integration of an evidence-based, systems perspective by nursing faculty supports development of nurses who can function safely and effectively in the current health care system. [J Nurs Educ. 2017;56(11):679-682.]. Copyright 2017, SLACK Incorporated.

“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

The Development of the Standard Lithuanian Language: Ecolinguistic Approach

Directory of Open Access Journals (Sweden)

Vaida Buivydienė

2014-06-01

Full Text Available The theory of standard languages is closely linked with the standardization policy and prevailing ideology. The language ideology comprises its value, experience and convictions related to language usage and its dis - course being influenced at institutional, local and global levels. Recently, in the last decades, foreign linguists have linked the theories of the development of standard lan- guages and their ideologies with an ecolinguistic approach towards language standardization phenomena. The article is based on Einar Haugen ’s theory about the development of standard languages and ecolinguistic statements and presents the stages of developing the standard language as well as the factors having an influ - ence on them. In conclusion, a strong political and social impact has been made on the development of the standard Lithuanian language. The stages of the progress of the standard Lithuanian language have rapidly changed each other, some have been held very close to one another and some still have been taken part.

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

Next Generation Space Interconnect Standard (NGSIS): a modular open standards approach for high performance interconnects for space

Science.gov (United States)

Collier, Charles Patrick

2017-04-01

The Next Generation Space Interconnect Standard (NGSIS) effort is a Government-Industry collaboration effort to define a set of standards for interconnects between space system components with the goal of cost effectively removing bandwidth as a constraint for future space systems. The NGSIS team has selected the ANSI/VITA 65 OpenVPXTM standard family for the physical baseline. The RapidIO protocol has been selected as the basis for the digital data transport. The NGSIS standards are developed to provide sufficient flexibility to enable users to implement a variety of system configurations, while meeting goals for interoperability and robustness for space. The NGSIS approach and effort represents a radical departure from past approaches to achieve a Modular Open System Architecture (MOSA) for space systems and serves as an exemplar for the civil, commercial, and military Space communities as well as a broader high reliability terrestrial market.

Standardized radiographic interpretation of thoracic tuberculosis in children

International Nuclear Information System (INIS)

Concepcion, Nathan David P.; Laya, Bernard F.; Andronikou, Savvas; Daltro, Pedro A.N.; Sanchez, Marion O.; Uy, Jacqueline Austine U.; Lim, Timothy Reynold U.

2017-01-01

There is a lack of standardized approach and terminology to classify the diverse spectrum of manifestations in tuberculosis. It is important to recognize the different clinical and radiographic patterns to guide treatment. As a result of changing epidemiology, there is considerable overlap in the radiologic presentations of primary tuberculosis and post-primary tuberculosis. In this article we promote a standardized approach in clinical and radiographic classification for children suspected of having or diagnosed with childhood tuberculosis. We propose standardized terms to diminish confusion and miscommunication, which can affect management. In addition, we present pitfalls and limitations of imaging. (orig.)

Standardized radiographic interpretation of thoracic tuberculosis in children

Energy Technology Data Exchange (ETDEWEB)

Concepcion, Nathan David P.; Laya, Bernard F. [St. Luke' s Medical Center, Section of Pediatric Radiology, Institute of Radiology, Taguig City (Philippines); St. Luke' s Medical Center, Section of Pediatric Radiology, Institute of Radiology, Quezon City (Philippines); Andronikou, Savvas [Bristol Royal Hospital for Children and the University of Bristol, Department of Paediatric Radiology, Bristol (United Kingdom); Daltro, Pedro A.N. [Clinica de Diagnostico por Imagem, Section of Pediatric Radiology, Rio de Janeiro (Brazil); Sanchez, Marion O. [St. Luke' s Medical Center, Section of Pediatric Pulmonology, Institute of Pulmonary Medicine, Quezon City (Philippines); Uy, Jacqueline Austine U. [St. Luke' s Medical Center, Section of Pediatric Radiology, Institute of Radiology, Taguig City (Philippines); Lim, Timothy Reynold U. [St. Luke' s Medical Center, Section of Pediatric Radiology, Institute of Radiology, Quezon City (Philippines)

2017-09-15

There is a lack of standardized approach and terminology to classify the diverse spectrum of manifestations in tuberculosis. It is important to recognize the different clinical and radiographic patterns to guide treatment. As a result of changing epidemiology, there is considerable overlap in the radiologic presentations of primary tuberculosis and post-primary tuberculosis. In this article we promote a standardized approach in clinical and radiographic classification for children suspected of having or diagnosed with childhood tuberculosis. We propose standardized terms to diminish confusion and miscommunication, which can affect management. In addition, we present pitfalls and limitations of imaging. (orig.)

Standardized radiographic interpretation of thoracic tuberculosis in children.

Science.gov (United States)

Concepcion, Nathan David P; Laya, Bernard F; Andronikou, Savvas; Daltro, Pedro A N; Sanchez, Marion O; Uy, Jacqueline Austine U; Lim, Timothy Reynold U

2017-09-01

There is a lack of standardized approach and terminology to classify the diverse spectrum of manifestations in tuberculosis. It is important to recognize the different clinical and radiographic patterns to guide treatment. As a result of changing epidemiology, there is considerable overlap in the radiologic presentations of primary tuberculosis and post-primary tuberculosis. In this article we promote a standardized approach in clinical and radiographic classification for children suspected of having or diagnosed with childhood tuberculosis. We propose standardized terms to diminish confusion and miscommunication, which can affect management. In addition, we present pitfalls and limitations of imaging.

Machine Learning Approaches for Clinical Psychology and Psychiatry.

Science.gov (United States)

Dwyer, Dominic B; Falkai, Peter; Koutsouleris, Nikolaos

2018-05-07

Machine learning approaches for clinical psychology and psychiatry explicitly focus on learning statistical functions from multidimensional data sets to make generalizable predictions about individuals. The goal of this review is to provide an accessible understanding of why this approach is important for future practice given its potential to augment decisions associated with the diagnosis, prognosis, and treatment of people suffering from mental illness using clinical and biological data. To this end, the limitations of current statistical paradigms in mental health research are critiqued, and an introduction is provided to critical machine learning methods used in clinical studies. A selective literature review is then presented aiming to reinforce the usefulness of machine learning methods and provide evidence of their potential. In the context of promising initial results, the current limitations of machine learning approaches are addressed, and considerations for future clinical translation are outlined.

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.

International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GVHD International Consortium.

Science.gov (United States)

Harris, Andrew C; Young, Rachel; Devine, Steven; Hogan, William J; Ayuk, Francis; Bunworasate, Udomsak; Chanswangphuwana, Chantiya; Efebera, Yvonne A; Holler, Ernst; Litzow, Mark; Ordemann, Rainer; Qayed, Muna; Renteria, Anne S; Reshef, Ran; Wölfl, Matthias; Chen, Yi-Bin; Goldstein, Steven; Jagasia, Madan; Locatelli, Franco; Mielke, Stephan; Porter, David; Schechter, Tal; Shekhovtsova, Zhanna; Ferrara, James L M; Levine, John E

2016-01-01

Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and nonrelapse mortality after allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed on by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multicenter clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance followed discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture, which may improve the reproducibility of GVHD clinical trials after further prospective validation. Copyright © 2016 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Development of Canadian seismic design approach and overview of seismic standards

Energy Technology Data Exchange (ETDEWEB)

Usmani, A. [Amec Foster Wheeler, Toronto, ON (Canada); Aziz, T. [TSAziz Consulting Inc., Mississauga, ON (Canada)

2015-07-01

Historically the Canadian seismic design approaches have evolved for CANDU® nuclear power plants to ensure that they are designed to withstand a design basis earthquake (DBE) and have margins to meet the safety requirements of beyond DBE (BDBE). While the Canadian approach differs from others, it is comparable and in some cases more conservative. The seismic requirements are captured in five CSA nuclear standards which are kept up to date and incorporate lessons learnt from recent seismic events. This paper describes the evolution of Canadian approach, comparison with others and provides an overview and salient features of CSA seismic standards. (author)

Natural background approach to setting radiation standards

International Nuclear Information System (INIS)

Adler, H.I.; Federow, H.; Weinberg, A.M.

1979-01-01

The suggestion has often been made that an additional radiation exposure imposed on humanity as a result of some important activity such as electricity generation would be acceptable if the exposure was small compared to the natural background. In order to make this concept quantitative and objective, we propose that small compared with the natural background be interpreted as the standard deviation (weighted with the exposed population) of the natural background. This use of the variation in natural background radiation is less arbitrary and requires fewer unfounded assumptions than some current approaches to standard-setting. The standard deviation is an easily calculated statistic that is small compared with the mean value for natural exposures of populations. It is an objectively determined quantity and its significance is generally understood. Its determination does not omit any of the pertinent data. When this method is applied to the population of the United States, it suggests that a dose of 20 mrem/year would be an acceptable standard. This is comparable to the 25 mrem/year suggested as the maximum allowable exposure to an individual from the complete uranium fuel cycle

A counterfactual p-value approach for benefit-risk assessment in clinical trials.

Science.gov (United States)

Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

2015-01-01

Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

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.

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.

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…

Analysis of approaches to classification of forms of non-standard employment

Directory of Open Access Journals (Sweden)

N. V. Dorokhova

2017-01-01

Full Text Available Currently becoming more widespread non-standard forms of employment. If this is not clear approach to the definition and maintenance of non-standard employment. In the article the analysis of diverse interpretations of the concept, on what basis, the author makes a conclusion about the complexity and contradictory nature of precarious employment as an economic category. It examines different approaches to classification of forms of precarious employment. The main forms of precarious employment such as flexible working year, flexible working week, flexible working hours, remote work, employees on call, shift forwarding; Agency employment, self-employment, negotiator, underemployment, over employment, employment on the basis of fixed-term contracts employment based on contract of civil-legal nature, one-time employment, casual employment, temporary employment, secondary employment and part-time. The author’s approach to classification of non-standard forms of employment, based on identifying the impact of atypical employment on the development of human potential. For the purpose of classification of non-standard employment forms from the standpoint of their impact on human development as the criteria of classification proposed in the following: working conditions, wages and social guarantees, possibility of workers ' participation in management, personal development and self-employment stability. Depending on what value each of these criteria, some form of non-standard employment can be attributed to the progressive or regressive. Classification of non-standard forms of employment should be the basis of the state policy of employment management.

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

Integrity, standards, and QC-related issues with big data in pre-clinical drug discovery.

Science.gov (United States)

Brothers, John F; Ung, Matthew; Escalante-Chong, Renan; Ross, Jermaine; Zhang, Jenny; Cha, Yoonjeong; Lysaght, Andrew; Funt, Jason; Kusko, Rebecca

2018-06-01

The tremendous expansion of data analytics and public and private big datasets presents an important opportunity for pre-clinical drug discovery and development. In the field of life sciences, the growth of genetic, genomic, transcriptomic and proteomic data is partly driven by a rapid decline in experimental costs as biotechnology improves throughput, scalability, and speed. Yet far too many researchers tend to underestimate the challenges and consequences involving data integrity and quality standards. Given the effect of data integrity on scientific interpretation, these issues have significant implications during preclinical drug development. We describe standardized approaches for maximizing the utility of publicly available or privately generated biological data and address some of the common pitfalls. We also discuss the increasing interest to integrate and interpret cross-platform data. Principles outlined here should serve as a useful broad guide for existing analytical practices and pipelines and as a tool for developing additional insights into therapeutics using big data. Copyright © 2018 Elsevier Inc. All rights reserved.

A System Approach to Advanced Practice Clinician Standardization and High Reliability.

Science.gov (United States)

Okuno-Jones, Susan; Siehoff, Alice; Law, Jennifer; Juarez, Patricia

Advanced practice clinicians (APCs) are an integral part of the health care team. Opportunities exist within Advocate Health Care to standardize and optimize APC practice across the system. To enhance the role and talents of APCs, an approach to role definition and optimization of practice and a structured approach to orientation and evaluation are shared. Although in the early stages of development, definition and standardization of accountabilities in a framework to support system changes are transforming the practice of APCs.

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.

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.'

A Gold Standards Approach to Training Instructors to Evaluate Crew Performance

Science.gov (United States)

Baker, David P.; Dismukes, R. Key

2003-01-01

The Advanced Qualification Program requires that airlines evaluate crew performance in Line Oriented Simulation. For this evaluation to be meaningful, instructors must observe relevant crew behaviors and evaluate those behaviors consistently and accurately against standards established by the airline. The airline industry has largely settled on an approach in which instructors evaluate crew performance on a series of event sets, using standardized grade sheets on which behaviors specific to event set are listed. Typically, new instructors are given a class in which they learn to use the grade sheets and practice evaluating crew performance observed on videotapes. These classes emphasize reliability, providing detailed instruction and practice in scoring so that all instructors within a given class will give similar scores to similar performance. This approach has value but also has important limitations; (1) ratings within one class of new instructors may differ from those of other classes; (2) ratings may not be driven primarily by the specific behaviors on which the company wanted the crews to be scored; and (3) ratings may not be calibrated to company standards for level of performance skill required. In this paper we provide a method to extend the existing method of training instructors to address these three limitations. We call this method the "gold standards" approach because it uses ratings from the company's most experienced instructors as the basis for training rater accuracy. This approach ties the training to the specific behaviors on which the experienced instructors based their ratings.

The implementation of a standardized approach to laparoscopic rectal surgery

DEFF Research Database (Denmark)

Aslak, Katrine Kanstrup; Bulut, Orhan

2012-01-01

BACKGROUND AND OBJECTIVES: The purpose of this study was to audit our results after implementation of a standardized operative approach to laparoscopic surgery for rectal cancer within a fast-track recovery program. METHODS: From January 2009 to February 2011, 100 consecutive patients underwent...... laparoscopic surgery on an intention-to-treat basis for rectal cancer. The results were retrospectively reviewed from a prospectively collected database. Operative steps and instrumentation for the procedure were standardized. A standard perioperative care plan was used. RESULTS: The following procedures were...

Clinical Approach to the Standardization of Oriental Medical Diagnostic Pattern Identification in Stroke Patients

Directory of Open Access Journals (Sweden)

Han Jung Kim

2011-01-01

Full Text Available In Korea, many stroke patients receive oriental medical care, in which pattern-identification plays a major role. Pattern-identification is Oriental Medicine's unique diagnostic system. This study attempted to standardize oriental medical pattern-identification for stroke patients. This was a community-based multicenter study that enrolled stroke patients within 30 days after their ictus. We assessed the patients' general characteristics and symptoms related to pattern-identification. Each patient's pattern was determined when two doctors had the same opinion. To determine which variables affect the pattern-identification, binary logistic regression analysis was used with the backward method. A total of 806 stroke patients were enrolled. Among 480 patients who were identified as having a certain pattern, 100 patients exhibited the Fire Heat Pattern, 210 patients the Phlegm Dampness Pattern, nine patients the Blood Stasis Pattern, 110 patients the Qi Deficiency Pattern, and 51 patients the Yin Deficiency Pattern. After the regression analysis, the predictive logistic equations for the Fire Heat, Phlegm Dampness, Qi Deficiency, and Yin Deficiency patterns were determined. The Blood Stasis Pattern was omitted because the sample size was too small. Predictive logistic equations were suggested for four of the patterns. These criteria would be useful in determining each stroke patient's pattern in clinics. However, further studies with large samples are necessary to validate and confirm these criteria.

Radiation safety standards : an environmentalist's approach

International Nuclear Information System (INIS)

Murthy, M.S.S.S.

1977-01-01

An integrated approach to the problem of environmental mutagenic hazards leads to the recommendation of a single dose-limit to the exposure of human beings to all man-made mutagenic agents including chemicals and radiation. However, because of lack of : (1) adequate information on chemical mutagens, (2) sufficient data on their risk estimates and (3) universally accepted dose-limites, control of chemical mutagens in the environment has not reached that advanced stage as that of radiation. In this situation, the radiation safety standards currently in use should be retained at their present levels. (M.G.B.)

AN EVALUATION OF SELECTED MOROCCAN ELT TEXTBOOKS: A STANDARDS-BASED APPROACH PERSPECTIVE

Directory of Open Access Journals (Sweden)

Hassan Ait Bouzid

2017-05-01

Full Text Available Standards-Based Approach to textbook evaluation has been blooming in recent decades. Nevertheless, this practice has received very little attention in Morocco.  The present study aims to bridge a gap in the literature of the Moroccan context by investigating the extent to which three locally designed ELT textbooks conform to the theoretical principles of the Standards-Based Approach which defines the teaching of English as a foreign language in the country (Ministry of National Education, 2007. Its objective is to examine whether and how these textbooks present contents that enable learners to meet the content standards included in the goal areas of Communications, Cultures, Connections and Comparisons. The study is informed by the theoretical framework of the Standards-Based Approach. It adopts a mixed-methods design that uses content analysis as a mixed data analysis method combining both quantitative and qualitative techniques. The findings reveal a number of shortcomings relevant to the representation of the content standards as several standards are not sufficiently addressed in the activities included in these textbooks. Eventually, some suggestions are addressed to policy makers, textbook designers and teachers to overcome the identified problems in current and future textbooks. The study is expected to sensitize ELT practitioners about the viability of using textbook evaluation in boosting both the quality of ELT textbooks and the quality of the teaching learning outcomes.

A Practical Approach to Tumor Heterogeneity in Clinical Research and Diagnostics.

Science.gov (United States)

Stanta, Giorgio; Bonin, Serena

2018-01-01

This Pathobiology issue tries to better define the complex phenomenon of intratumor heterogeneity (ITH), mostly from a practical point of view. This topic has been chosen because ITH is a central issue in tumor development and has to be investigated directly in patient tissue and immediately applied in the treatment of the presenting patient. Different types of ITH should be considered: clonal genetic and epigenetic evolution, morphological heterogeneity, and tumor sampling, heterogeneity resulting from microenvironmental autocrine and paracrine interaction, and stochastic plasticity related to different functional cell efficiencies. For a higher level of reproducibility in clinical research and diagnostics, it is necessary to establish standardized analytical methods, including microdissection. In situ techniques can be pivotal to explore tumor microenvironment and can be improved with associated digital analysis. Liquid biopsies for plasma DNA analysis are at present the best method to study recurrent tumors with treatment adaptation, and widespread clinical use could be beneficial. The different types of tumor genomic instabilities could have pragmatic applications to rank ITH for clinical applications: treatment approaches differ in patients with a high nucleotide mutation rate and patients with high copy number alterations. © 2017 S. Karger AG, Basel.

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

EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos).

Science.gov (United States)

Khashab, Mouen A; Valeshabad, Ali Kord; Modayil, Rani; Widmer, Jessica; Saxena, Payal; Idrees, Mehak; Iqbal, Shahzad; Kalloo, Anthony N; Stavropoulos, Stavros N

2013-11-01

EUS-guided biliary drainage (EGBD) can be performed via direct transluminal or rendezvous techniques. It is unknown how both techniques compare in terms of efficacy and adverse events. To describe outcomes of EGBD performed by using a standardized approach and compare outcomes of rendezvous and transluminal techniques. Retrospective analysis of prospectively collected data. Two tertiary-care centers. Consecutive jaundiced patients with distal malignant biliary obstruction who underwent EGBD after failed ERCP between July 2006 and December 2012 were included. EGBD by using a standardized algorithm. Technical success, clinical success, and adverse events. During the study period, 35 patients underwent EGBD (rendezvous n = 13, transluminal n = 20). Technical success was achieved in 33 patients (94%), and clinical success was attained in 32 of 33 patients (97.0%). The mean postprocedure bilirubin level was 1.38 mg/dL in the rendezvous group and 1.33 mg/dL in the transluminal group (P = .88). Similarly, length of hospital stay was not different between groups (P = .23). There was no significant difference in adverse event rate between rendezvous and transluminal groups (15.4% vs 10%; P = .64). Long-term outcomes were comparable between groups, with 1 stent migration in the rendezvous group at 62 days and 1 stent occlusion in the transluminal group at 42 days after EGBD. Retrospective analysis, small number of patients, and selection bias. EGBD is safe and effective when the described standardized approach is used. Stent occlusion is not common during long-term follow-up. Both rendezvous and direct transluminal techniques seem to be equally effective and safe. The latter approach is a reasonable alternative to rendezvous EGBD. Copyright © 2013. Published by Mosby, Inc.

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.

Do Energy Efficiency Standards Improve Quality? Evidence from a Revealed Preference Approach

Energy Technology Data Exchange (ETDEWEB)

Houde, Sebastien [Univ. of Maryland, College Park, MD (United States); Spurlock, C. Anna [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

2015-06-01

Minimum energy efficiency standards have occupied a central role in U.S. energy policy for more than three decades, but little is known about their welfare effects. In this paper, we employ a revealed preference approach to quantify the impact of past revisions in energy efficiency standards on product quality. The micro-foundation of our approach is a discrete choice model that allows us to compute a price-adjusted index of vertical quality. Focusing on the appliance market, we show that several standard revisions during the period 2001-2011 have led to an increase in quality. We also show that these standards have had a modest effect on prices, and in some cases they even led to decreases in prices. For revision events where overall quality increases and prices decrease, the consumer welfare effect of tightening the standards is unambiguously positive. Finally, we show that after controlling for the effect of improvement in energy efficiency, standards have induced an expansion of quality in the non-energy dimension. We discuss how imperfect competition can rationalize these results.

Whole-genome-based Mycobacterium tuberculosis surveillance: a standardized, portable, and expandable approach.

Science.gov (United States)

Kohl, Thomas A; Diel, Roland; Harmsen, Dag; Rothgänger, Jörg; Walter, Karen Meywald; Merker, Matthias; Weniger, Thomas; Niemann, Stefan

2014-07-01

Whole-genome sequencing (WGS) allows for effective tracing of Mycobacterium tuberculosis complex (MTBC) (tuberculosis pathogens) transmission. However, it is difficult to standardize and, therefore, is not yet employed for interlaboratory prospective surveillance. To allow its widespread application, solutions for data standardization and storage in an easily expandable database are urgently needed. To address this question, we developed a core genome multilocus sequence typing (cgMLST) scheme for clinical MTBC isolates using the Ridom SeqSphere(+) software, which transfers the genome-wide single nucleotide polymorphism (SNP) diversity into an allele numbering system that is standardized, portable, and not computationally intensive. To test its performance, we performed WGS analysis of 26 isolates with identical IS6110 DNA fingerprints and spoligotyping patterns from a longitudinal outbreak in the federal state of Hamburg, Germany (notified between 2001 and 2010). The cgMLST approach (3,041 genes) discriminated the 26 strains with a resolution comparable to that of SNP-based WGS typing (one major cluster of 22 identical or closely related and four outlier isolates with at least 97 distinct SNPs or 63 allelic variants). Resulting tree topologies are highly congruent and grouped the isolates in both cases analogously. Our data show that SNP- and cgMLST-based WGS analyses facilitate high-resolution discrimination of longitudinal MTBC outbreaks. cgMLST allows for a meaningful epidemiological interpretation of the WGS genotyping data. It enables standardized WGS genotyping for epidemiological investigations, e.g., on the regional public health office level, and the creation of web-accessible databases for global TB surveillance with an integrated early warning system. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

Standardization versus customization of glucose reporting.

Science.gov (United States)

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.

A Clinical Approach to Vulvar Ulcers.

Science.gov (United States)

Stewart, Kristen M A

2017-09-01

This article discusses the differential diagnosis of vulvar ulcers and describes a general clinical approach to this common but nonspecific examination finding. The differential diagnosis includes sexually and nonsexually transmitted infections, dermatitides, trauma, neoplasms, hormonally induced ulcers, and drug reactions. Patient history and physical examination provide important clues to the cause of a vulvar ulcer. However, laboratory testing is usually required for accurate diagnosis because the clinical presentation is often nonspecific and may be atypical due to secondary conditions. Copyright © 2017 Elsevier Inc. All rights reserved.

Proposal for a collaborative approach to clinical teaching.

Science.gov (United States)

Beckman, Thomas J; Lee, Mark C

2009-04-01

Evidence suggests that inexperienced clinical teachers are often controlling and noninteractive. Adult learning theory states that mature students prefer shared and self-directed learning and that skillful teachers favor facilitating discussions over transmitting knowledge. Similarly, education research shows that effective clinical teachers invest in relationships with learners, ask questions to diagnose learners, communicate complex information clearly, and provide meaningful feedback. On the basis of these principles, we propose a collaborative approach to clinical teaching that has 4 essential components: (1) establish a relationship with the learner, (2) diagnose the learner, (3) use teaching frameworks that engage learners, and (4) develop teaching scripts and a personal philosophy. This article includes suggestions for creating a positive learning climate, asking higher-order questions, providing meaningful feedback, and developing teaching scripts. We believe that practicing this approach, which emphasizes respectful teacher-learner relationships, improves the quality of every clinical teaching encounter.

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.

Risk Management Standards: Towards a contemporary, organisation-wide management approach

OpenAIRE

Koutsoukis, Nikitas-Spiros

2010-01-01

Risk management has been progressively evolving into a systemic approach for organisational decision making in today’s dynamic economic environment of the global era. In this context, risk management is reaching beyond its traditional finance and insurance application context and is entering the sphere of generic, organisation-wide management approaches. In support of this argument we consider four generic risk management standards issued at the institutional, national or international level...

The clinical approach to movement disorders.

NARCIS (Netherlands)

Abdo, W.F.; Warrenburg, B.P.C. van de; Burn, D.J.; Quinn, N.P.; Bloem, B.R.

2010-01-01

Movement disorders are commonly encountered in the clinic. In this Review, aimed at trainees and general neurologists, we provide a practical step-by-step approach to help clinicians in their 'pattern recognition' of movement disorders, as part of a process that ultimately leads to the diagnosis.

The standardization debate: A conflation trap in critical care electroencephalography.

Science.gov (United States)

Ng, Marcus C; Gaspard, Nicolas; Cole, Andrew J; Hoch, Daniel B; Cash, Sydney S; Bianchi, Matt; O'Rourke, Deirdre A; Rosenthal, Eric S; Chu, Catherine J; Westover, M Brandon

2015-01-01

Persistent uncertainty over the clinical significance of various pathological continuous electroencephalography (cEEG) findings in the intensive care unit (ICU) has prompted efforts to standardize ICU cEEG terminology and an ensuing debate. We set out to understand the reasons for, and a satisfactory resolution to, this debate. We review the positions for and against standardization, and examine their deeper philosophical basis. We find that the positions for and against standardization are not fundamentally irreconcilable. Rather, both positions stem from conflating the three cardinal steps in the classic approach to EEG, which we term "description", "interpretation", and "prescription". Using real-world examples we show how this conflation yields muddled clinical reasoning and unproductive debate among electroencephalographers that is translated into confusion among treating clinicians. We propose a middle way that judiciously uses both standardized terminology and clinical reasoning to disentangle these critical steps and apply them in proper sequence. The systematic approach to ICU cEEG findings presented herein not only resolves the standardization debate but also clarifies clinical reasoning by helping electroencephalographers assign appropriate weights to cEEG findings in the face of uncertainty. Copyright © 2014 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

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

Directory of Open Access Journals (Sweden)

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

Clinical Significance: a Therapeutic Approach Topsychological Assessment in Treatment Planning

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Afolabi Olusegun Emmanuel

2015-06-01

Full Text Available Psychological assessment has long been reported as a key component of clinical psychology. This paper examines the complexities surrounding the clinical significance of therapeutic approach to treatment planning. To achieve this objective, the paper searched and used the PsycINFO and PubMed databases and the reference sections of chapters and journal articles to analysed, 1 a strong basis for the usage of therapeutic approach to psychological assessment in treatment plans, 2 explained the conceptual meaning of clinical significant change in therapeutic assessment, 3 answered some of the questions regarding practicability and the clinical significance of therapeutic approach to treatment plans, particularly during or before treatment, 4 linked therapeutic assessment to change in clients’ clinical impression, functioning and therapeutic needs 5 analysed the empirically documenting clinically significant change in therapeutic assessment. Finally, the study suggested that though therapeutic assessment is not sufficient for the systematic study of psychotherapy outcome and process, it is still consistent with both the layman and professional expectations regarding treatment outcome and also provides a precise method for classifying clients as ‘changed’ or ‘unchanged’ on the basis of clinical significance criteria.

Revisiting photodynamic therapy dosimetry: reductionist & surrogate approaches to facilitate clinical success

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Pogue, Brian W.; Elliott, Jonathan T.; Kanick, Stephen C.; Davis, Scott C.; Samkoe, Kimberley S.; Maytin, Edward V.; Pereira, Stephen P.; Hasan, Tayyaba

2016-04-01

Photodynamic therapy (PDT) can be a highly complex treatment, with many parameters influencing treatment efficacy. The extent to which dosimetry is used to monitor and standardize treatment delivery varies widely, ranging from measurement of a single surrogate marker to comprehensive approaches that aim to measure or estimate as many relevant parameters as possible. Today, most clinical PDT treatments are still administered with little more than application of a prescribed drug dose and timed light delivery, and thus the role of patient-specific dosimetry has not reached widespread clinical adoption. This disconnect is at least partly due to the inherent conflict between the need to measure and understand multiple parameters in vivo in order to optimize treatment, and the need for expedience in the clinic and in the regulatory and commercialization process. Thus, a methodical approach to selecting primary dosimetry metrics is required at each stage of translation of a treatment procedure, moving from complex measurements to understand PDT mechanisms in pre-clinical and early phase I trials, towards the identification and application of essential dose-limiting and/or surrogate measurements in phase II/III trials. If successful, identifying the essential and/or reliable surrogate dosimetry measurements should help facilitate increased adoption of clinical PDT. In this paper, examples of essential dosimetry points and surrogate dosimetry tools that may be implemented in phase II/III trials are discussed. For example, the treatment efficacy as limited by light penetration in interstitial PDT may be predicted by the amount of contrast uptake in CT, and so this could be utilized as a surrogate dosimetry measurement to prescribe light doses based upon pre-treatment contrast. Success of clinical ALA-based skin lesion treatment is predicted almost uniquely by the explicit or implicit measurements of photosensitizer and photobleaching, yet the individualization of treatment

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

Science.gov (United States)

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.

XML-based clinical data standardisation in the National Health Service Scotland

Directory of Open Access Journals (Sweden)

Raluca Bunduchi

2006-12-01

Full Text Available The objective of this paper is to clarify the role that socio-economic factors played in shaping the development of XML-based clinical data standards in the National Health Service in Scotland from 2000 to 2004. The paper discusses the NHS Scotland approach to clinical data standardisation, emphasising the actors involved, their choices during the standard development process and the factors that have shaped these choices. The case suggests that the NHS Scotland approach to clinical data standardisation is shaped by strong political pressures for fast development of an integrated electronic patient care system, economic pressures for high efficiency and cost reductions, and organisational requirements for strong clinical support. Such economic, political and organisational pressures explain the informal approach to standard development, the emphasis on fast system development and strong clinical involvement. At the same time, market factors explain the low commitment of the IT vendors, which might have otherwise put significant pressure onNHSScotland to pursue a more formalised standardisation approach within an internationally recognised standard-setting body.

[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.

The Clinical and Client-Centered Approach to Counseling.

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Rivas, Richard G.

This review analyzes the clinical and client-centered approaches to counseling. Clinical counseling separated from vocational counseling in the third decade of this century. A split took place between guidance and discipline. The mental hygiene movement facilitated this split. In 1942 Carl Rogers made an impact on counseling theory with the…

One-Tube-Only Standardized Site-Directed Mutagenesis: An Alternative Approach to Generate Amino Acid Substitution Collections.

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Janire Mingo

Full Text Available Site-directed mutagenesis (SDM is a powerful tool to create defined collections of protein variants for experimental and clinical purposes, but effectiveness is compromised when a large number of mutations is required. We present here a one-tube-only standardized SDM approach that generates comprehensive collections of amino acid substitution variants, including scanning- and single site-multiple mutations. The approach combines unified mutagenic primer design with the mixing of multiple distinct primer pairs and/or plasmid templates to increase the yield of a single inverse-PCR mutagenesis reaction. Also, a user-friendly program for automatic design of standardized primers for Ala-scanning mutagenesis is made available. Experimental results were compared with a modeling approach together with stochastic simulation data. For single site-multiple mutagenesis purposes and for simultaneous mutagenesis in different plasmid backgrounds, combination of primer sets and/or plasmid templates in a single reaction tube yielded the distinct mutations in a stochastic fashion. For scanning mutagenesis, we found that a combination of overlapping primer sets in a single PCR reaction allowed the yield of different individual mutations, although this yield did not necessarily follow a stochastic trend. Double mutants were generated when the overlap of primer pairs was below 60%. Our results illustrate that one-tube-only SDM effectively reduces the number of reactions required in large-scale mutagenesis strategies, facilitating the generation of comprehensive collections of protein variants suitable for functional analysis.

A modified artificial immune system based pattern recognition approach -- an application to clinic diagnostics

Science.gov (United States)

Zhao, Weixiang; Davis, Cristina E.

2011-01-01

Objective This paper introduces a modified artificial immune system (AIS)-based pattern recognition method to enhance the recognition ability of the existing conventional AIS-based classification approach and demonstrates the superiority of the proposed new AIS-based method via two case studies of breast cancer diagnosis. Methods and materials Conventionally, the AIS approach is often coupled with the k nearest neighbor (k-NN) algorithm to form a classification method called AIS-kNN. In this paper we discuss the basic principle and possible problems of this conventional approach, and propose a new approach where AIS is integrated with the radial basis function – partial least square regression (AIS-RBFPLS). Additionally, both the two AIS-based approaches are compared with two classical and powerful machine learning methods, back-propagation neural network (BPNN) and orthogonal radial basis function network (Ortho-RBF network). Results The diagnosis results show that: (1) both the AIS-kNN and the AIS-RBFPLS proved to be a good machine leaning method for clinical diagnosis, but the proposed AIS-RBFPLS generated an even lower misclassification ratio, especially in the cases where the conventional AIS-kNN approach generated poor classification results because of possible improper AIS parameters. For example, based upon the AIS memory cells of “replacement threshold = 0.3”, the average misclassification ratios of two approaches for study 1 are 3.36% (AIS-RBFPLS) and 9.07% (AIS-kNN), and the misclassification ratios for study 2 are 19.18% (AIS-RBFPLS) and 28.36% (AIS-kNN); (2) the proposed AIS-RBFPLS presented its robustness in terms of the AIS-created memory cells, showing a smaller standard deviation of the results from the multiple trials than AIS-kNN. For example, using the result from the first set of AIS memory cells as an example, the standard deviations of the misclassification ratios for study 1 are 0.45% (AIS-RBFPLS) and 8.71% (AIS-kNN) and those for

Standardized Ki67 Diagnostics Using Automated Scoring--Clinical Validation in the GeparTrio Breast Cancer Study.

Science.gov (United States)

Klauschen, Frederick; Wienert, Stephan; Schmitt, Wolfgang D; Loibl, Sibylle; Gerber, Bernd; Blohmer, Jens-Uwe; Huober, Jens; Rüdiger, Thomas; Erbstößer, Erhard; Mehta, Keyur; Lederer, Bianca; Dietel, Manfred; Denkert, Carsten; von Minckwitz, Gunter

2015-08-15

Scoring proliferation through Ki67 immunohistochemistry is an important component in predicting therapy response to chemotherapy in patients with breast cancer. However, recent studies have cast doubt on the reliability of "visual" Ki67 scoring in the multicenter setting, particularly in the lower, yet clinically important, proliferation range. Therefore, an accurate and standardized Ki67 scoring is pivotal both in routine diagnostics and larger multicenter studies. We validated a novel fully automated Ki67 scoring approach that relies on only minimal a priori knowledge on cell properties and requires no training data for calibration. We applied our approach to 1,082 breast cancer samples from the neoadjuvant GeparTrio trial and compared the performance of automated and manual Ki67 scoring. The three groups of autoKi67 as defined by low (≤ 15%), medium (15.1%-35%), and high (>35%) automated scores showed pCR rates of 5.8%, 16.9%, and 29.5%, respectively. AutoKi67 was significantly linked to prognosis with overall and progression-free survival P values P(OS) cancer that correlated with clinical endpoints and is deployable in routine diagnostics. It may thus help to solve recently reported reliability concerns in Ki67 diagnostics. ©2014 American Association for Cancer Research.

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

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…

Targeting NK cells for anti-cancer immunotherapy: clinical and pre-clinical approaches

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Sebastian eCarotta

2016-04-01

Full Text Available The recent success of checkpoint blockade has highlighted the potential of immunotherapy approaches for cancer treatment. While the majority of approved immunotherapy drugs target T cell subsets, it is appreciated that other components of the immune system have important roles in tumor immune-surveillance as well and thus represent promising additional targets for immunotherapy. Natural killer cells are the body’s first line of defense against infected or transformed cells as they kill target cells in an antigen-independent manner. Although several studies have clearly demonstrated the active role of NK cells in cancer-immune surveillance, only few clinically approved therapies currently exist that harness their potential. Our increased understanding of NK cell biology over the past few years has renewed the interest in NK cell based anti-cancer therapies, which has lead to a steady increase of NK cell based clinical and pre-clinical trials. Here, the role of NK cells in cancer immunesurveillance is summarized and several novel approaches to enhance NK cell cytotoxicity against cancer are discussed.

To Teach Standard English or World Englishes? A Balanced Approach to Instruction

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Farrell, Thomas S. C.; Martin, Sonia

2009-01-01

This article suggests that English language teachers should consider all varieties of English, not just British Standard English or American Standard English. In order to better prepare students for the global world, and to show them that their own English is valued, teachers can implement a balanced approach that incorporates the teaching and…

Updating contextualized clinical practice guidelines on stroke rehabilitation and low back pain management using a novel assessment framework that standardizes decisions.

Science.gov (United States)

Gambito, Ephraim D V; Gonzalez-Suarez, Consuelo B; Grimmer, Karen A; Valdecañas, Carolina M; Dizon, Janine Margarita R; Beredo, Ma Eulalia J; Zamora, Marcelle Theresa G

2015-11-04

Clinical practice guidelines need to be regularly updated with current literature in order to remain relevant. This paper reports on the approach taken by the Philippine Academy of Rehabilitation Medicine (PARM). This dovetails with its writing guide, which underpinned its foundational work in contextualizing guidelines for stroke and low back pain (LBP) in 2011. Working groups of Filipino rehabilitation physicians and allied health practitioners met to reconsider and modify, where indicated, the 'typical' Filipino patient care pathways established in the foundation guidelines. New clinical guidelines on stroke and low back pain which had been published internationally in the last 3 years were identified using a search of electronic databases. The methodological quality of each guideline was assessed using the iCAHE Guideline Quality Checklist, and only those guidelines which provided full text references, evidence hierarchy and quality appraisal of the included literature, were included in the PARM update. Each of the PARM-endorsed recommendations was then reviewed, in light of new literature presented in the included clinical guidelines. A novel standard updating approach was developed based on the criteria reported by Johnston et al. (Int J Technol Assess Health Care 19(4):646-655, 2003) and then modified to incorporate wording from the foundational PARM writing guide. The new updating tool was debated, pilot-tested and agreed upon by the PARM working groups, before being applied to the guideline updating process. Ten new guidelines on stroke and eleven for low back pain were identified. Guideline quality scores were moderate to good, however not all guidelines comprehensively linked the evidence body underpinning recommendations with the literature. Consequently only five stroke and four low back pain guidelines were included. The modified PARM updating guide was applied by all working groups to ensure standardization of the wording of updated recommendations

A Creative Approach to the Common Core Standards: The Da Vinci Curriculum

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Chaucer, Harry

2012-01-01

"A Creative Approach to the Common Core Standards: The Da Vinci Curriculum" challenges educators to design programs that boldly embrace the Common Core State Standards by imaginatively drawing from the genius of great men and women such as Leonardo da Vinci. A central figure in the High Renaissance, Leonardo made extraordinary contributions as a…

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

International Nuclear Information System (INIS)

Kun, Larry E.

1997-01-01

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. The clinical characteristics and disease extent largely determine the relative merits of available 'standard' and investigational therapeutic approaches. Treatment outcome, including disease control and functional integrity, is dependent upon tumor type and site, age at presentation, and disease extent. An understanding of the clinical, neuroimaging, and histologic characteristics as they relate to decisions regarding therapy is critical to the radiation oncologist. Appropriate radiation therapy is central to curative therapy for a majority of pediatric brain tumor presentations. Technical advances in neurosurgery provide greater safety for 'gross total resection' in a majority of hemispheric astrocytomas and medulloblastomas. The relative roles of radiation therapy and chemotherapy for centrally located astrocytomas (e.g., diencephalic, optic pathway) need to be analyzed in the context of initial and overall disease control, neurotoxicities, and potential modifications in the risk:benefit ratio apparent in the introduction of 3-dimensional radiation techniques. Modifications in radiation delivery are important components of current investigations in medulloblastoma; the rationale for contemporary cooperative group trials will be presented as well as the background data re surgical, radiotherapeutic, and

Revisiting photodynamic therapy dosimetry: reductionist and surrogate approaches to facilitate clinical success

International Nuclear Information System (INIS)

Pogue, Brian W; Elliott, Jonathan T; Kanick, Stephen C; Davis, Scott C; Samkoe, Kimberley S; Maytin, Edward V; Pereira, Stephen P; Hasan, Tayyaba

2016-01-01

Photodynamic therapy (PDT) can be a highly complex treatment, with many parameters influencing treatment efficacy. The extent to which dosimetry is used to monitor and standardize treatment delivery varies widely, ranging from measurement of a single surrogate marker to comprehensive approaches that aim to measure or estimate as many relevant parameters as possible. Today, most clinical PDT treatments are still administered with little more than application of a prescribed drug dose and timed light delivery, and thus the role of patient-specific dosimetry has not reached widespread clinical adoption. This disconnect is at least partly due to the inherent conflict between the need to measure and understand multiple parameters in vivo in order to optimize treatment, and the need for expedience in the clinic and in the regulatory and commercialization process. Thus, a methodical approach to selecting primary dosimetry metrics is required at each stage of translation of a treatment procedure, moving from complex measurements to understand PDT mechanisms in pre-clinical and early phase I trials, towards the identification and application of essential dose-limiting and/or surrogate measurements in phase II/III trials. If successful, identifying the essential and/or reliable surrogate dosimetry measurements should help facilitate increased adoption of clinical PDT. In this paper, examples of essential dosimetry points and surrogate dosimetry tools that may be implemented in phase II/III trials are discussed. For example, the treatment efficacy as limited by light penetration in interstitial PDT may be predicted by the amount of contrast uptake in CT, and so this could be utilized as a surrogate dosimetry measurement to prescribe light doses based upon pre-treatment contrast. Success of clinical ALA-based skin lesion treatment is predicted almost uniquely by the explicit or implicit measurements of photosensitizer and photobleaching, yet the individualization of treatment

The natural background approach to setting radiation standards

International Nuclear Information System (INIS)

Adler, H.I.; Federow, H.; Weinberg, A.M.

1979-01-01

The suggestion has often been made that an additional radiation exposure imposed on humanity as a result of some important activity such as electricity generation would be acceptable if the exposure was 'small' compared to the natural background. In order to make this concept quantitative and objective, we propose that 'small compared with the natural background' be interpreted as the standard deviation (weighted with the exposed population) of the natural background. We believe that this use of the variation in natural background radiation is less arbitrary and requires fewer unfounded assumptions than some current approaches to standard-setting. The standard deviation is an easily calculated statistic that is small compared with the mean value for natural exposures of populations. It is an objectively determined quantity and its significance is generally understood. Its determination does not omit any of the pertinent data. When this method is applied to the population of the USA, it implies that a dose of 20 mrem/year would be an acceptable standard. This is closely comparable to the 25 mrem/year suggested by the Environmental Protection Agency as the maximum allowable exposure to an individual in the general population as a result of the operation of the complete uranium fuel cycle. Other agents for which a natural background exists can be treated in the same way as radiation. In addition, a second method for determining permissible exposure levels for agents other than radiation is presented. This method makes use of the natural background radiation data as a primary standard. Some observations on benzo(a)pyrene, using this latter method, are presented. (author)

Teaching emergent bilingual students flexible approaches in an era of new standards

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Proctor, C Patrick; Hiebert, Elfrieda H

2016-01-01

Recent educational reform initiatives such as the Common Core State Standards (CCSS) largely fail to address the needs--or tap into the unique resources--of students who are developing literacy skills in both English and a home language. This book discusses ways to meet the challenges that current standards pose for teaching emergent bilingual students in grades K-8. Leading experts describe effective, standards-aligned instructional approaches and programs expressly developed to promote bilingual learners' academic vocabulary, comprehension, speaking, writing, and content learning. Innovative

Developing clinical strength-of-evidence approach to define HIV-associated malignancies for cancer registration in Kenya.

Science.gov (United States)

Korir, Anne; Mauti, Nathan; Moats, Pamela; Gurka, Matthew J; Mutuma, Geoffrey; Metheny, Christine; Mwamba, Peter M; Oyiro, Peter O; Fisher, Melanie; Ayers, Leona W; Rochford, Rosemary; Mwanda, Walter O; Remick, Scot C

2014-01-01

Sub-Saharan Africa cancer registries are beset by an increasing cancer burden further exacerbated by the AIDS epidemic where there are limited capabilities for cancer-AIDS match co-registration. We undertook a pilot study based on a "strength-of-evidence" approach using clinical data that is abstracted at the time of cancer registration for purposes of linking cancer diagnosis to AIDS diagnosis. The standard Nairobi Cancer Registry form was modified for registrars to abstract the following clinical data from medical records regarding HIV infection/AIDS in a hierarchal approach at time of cancer registration from highest-to-lowest strength-of-evidence: 1) documentation of positive HIV serology; 2) antiretroviral drug prescription; 3) CD4+ lymphocyte count; and 4) WHO HIV clinical stage or immune suppression syndrome (ISS), which is Kenyan terminology for AIDS. Between August 1 and October 31, 2011 a total of 1,200 cancer cases were registered. Of these, 171 cases (14.3%) met clinical strength-of-evidence criteria for association with HIV infection/AIDS; 69% (118 cases were tumor types with known HIV association - Kaposi's sarcoma, cervical cancer, non-Hodgkin's and Hodgkin's lymphoma, and conjunctiva carcinoma) and 31% (53) were consistent with non-AIDS defining cancers. Verifiable positive HIV serology was identified in 47 (27%) cases for an absolute seroprevalence rate of 4% among the cancer registered cases with an upper boundary of 14% among those meeting at least one of strength-of-evidence criteria. This pilot demonstration of a hierarchal, clinical strength-of-evidence approach for cancer-AIDS registration in Kenya establishes feasibility, is readily adaptable, pragmatic, and does not require additional resources for critically under staffed cancer registries. Cancer is an emerging public health challenge, and African nations need to develop well designed population-based studies in order to better define the impact and spectrum of malignant disease in the

Video-assisted thoracoscopic surgery (VATS) lobectomy using a standardized anterior approach

DEFF Research Database (Denmark)

Hansen, Henrik Jessen; Petersen, René Horsleben; Christensen, Merete

2011-01-01

Lobectomy using video-assisted thoracoscopic surgery (VATS) still is a controversial operation despite its many observed benefits. The controversy may be due to difficulties performing the procedure. This study addresses a standardized anterior approach facilitating the operation....

Current National Approach to Healthcare ICT Standardization: Focus on Progress in New Zealand.

Science.gov (United States)

Park, Young-Taek; Atalag, Koray

2015-07-01

Many countries try to efficiently deliver high quality healthcare services at lower and manageable costs where healthcare information and communication technologies (ICT) standardisation may play an important role. New Zealand provides a good model of healthcare ICT standardisation. The purpose of this study was to review the current healthcare ICT standardisation and progress in New Zealand. This study reviewed the reports regarding the healthcare ICT standardisation in New Zealand. We also investigated relevant websites related with the healthcare ICT standards, most of which were run by the government. Then, we summarised the governance structure, standardisation processes, and their output regarding the current healthcare ICT standards status of New Zealand. New Zealand government bodies have established a set of healthcare ICT standards and clear guidelines and procedures for healthcare ICT standardisation. Government has actively participated in various enactments of healthcare ICT standards from the inception of ideas to their eventual retirement. Great achievements in eHealth have already been realized, and various standards are currently utilised at all levels of healthcare regionally and nationally. Standard clinical terminologies, such as International Classification of Diseases (ICD) and Systematized Nomenclature of Medicine - Clinical Terms (SNOMED-CT) have been adopted and Health Level Seven (HL7) standards are actively used in health information exchanges. The government to New Zealand has well organised ICT institutions, guidelines, and regulations, as well as various programs, such as e-Medications and integrated care services. Local district health boards directly running hospitals have effectively adopted various new ICT standards. They might already be benefiting from improved efficiency resulting from healthcare ICT standardisation.

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.

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.

Cow-specific treatment of clinical mastitis: an economic approach

NARCIS (Netherlands)

Steeneveld, W.; Werven, van T.; Barkema, H.W.; Hogeveen, H.

2011-01-01

Under Dutch circumstances, most clinical mastitis (CM) cases of cows on dairy farms are treated with a standard intramammary antimicrobial treatment. Several antimicrobial treatments are available for CM, differing in antimicrobial compound, route of application, duration, and cost. Because cow

A clinical audit programme for diagnostic radiology: The Approach adopted by the international atomic energy agency

International Nuclear Information System (INIS)

Faulkner, K.; Jaervinen, H.; Butler, P.; McLean, I. D.; Pentecost, M.; Rickard, M.; Abdullah, B.

2010-01-01

The International Atomic Energy Agency (IAEA) has a mandate to assist member states in areas of human health and particularly in the use of radiation for diagnosis and treatment. Clinical audit is seen as an essential tool to assist in assuring the quality of radiation medicine, particularly in the instance of multidisciplinary audit of diagnostic radiology. Consequently, an external clinical audit programme has been developed by the IAEA to examine the structure and processes existent at a clinical site, with the basic objectives of: (1) improvement in the quality of patient care; (2) promotion of the effective use of resources; (3) enhancement of the provision and organisation of clinical services; (4) further professional education and training. These objectives apply in four general areas of service delivery, namely quality management and infrastructure, patient procedures, technical procedures and education, training and research. In the IAEA approach, the audit process is initiated by a request from the centre seeking the audit. A three-member team, comprising a radiologist, medical physicist and radiographer, subsequently undertakes a 5-d audit visit to the clinical site to perform the audit and write the formal audit report. Preparation for the audit visit is crucial and involves the local clinical centre completing a form, which provides the audit team with information on the clinical centre. While all main aspects of clinical structure and process are examined, particular attention is paid to radiation-related activities as described in the relevant documents such as the IAEA Basic Safety Standards, the Code of Practice for Dosimetry in Diagnostic Radiology and related equipment and quality assurance documentation. It should be stressed, however, that the clinical audit does not have any regulatory function. The main purpose of the IAEA approach to clinical audit is one of promoting quality improvement and learning. This paper describes the background to

A clinical audit programme for diagnostic radiology: the approach adopted by the International Atomic Energy Agency.

Science.gov (United States)

Faulkner, K; Järvinen, H; Butler, P; McLean, I D; Pentecost, M; Rickard, M; Abdullah, B

2010-01-01

The International Atomic Energy Agency (IAEA) has a mandate to assist member states in areas of human health and particularly in the use of radiation for diagnosis and treatment. Clinical audit is seen as an essential tool to assist in assuring the quality of radiation medicine, particularly in the instance of multidisciplinary audit of diagnostic radiology. Consequently, an external clinical audit programme has been developed by the IAEA to examine the structure and processes existent at a clinical site, with the basic objectives of: (1) improvement in the quality of patient care; (2) promotion of the effective use of resources; (3) enhancement of the provision and organisation of clinical services; (4) further professional education and training. These objectives apply in four general areas of service delivery, namely quality management and infrastructure, patient procedures, technical procedures and education, training and research. In the IAEA approach, the audit process is initiated by a request from the centre seeking the audit. A three-member team, comprising a radiologist, medical physicist and radiographer, subsequently undertakes a 5-d audit visit to the clinical site to perform the audit and write the formal audit report. Preparation for the audit visit is crucial and involves the local clinical centre completing a form, which provides the audit team with information on the clinical centre. While all main aspects of clinical structure and process are examined, particular attention is paid to radiation-related activities as described in the relevant documents such as the IAEA Basic Safety Standards, the Code of Practice for Dosimetry in Diagnostic Radiology and related equipment and quality assurance documentation. It should be stressed, however, that the clinical audit does not have any regulatory function. The main purpose of the IAEA approach to clinical audit is one of promoting quality improvement and learning. This paper describes the background to

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

Clinical decision-making and therapeutic approaches in osteopathy - a qualitative grounded theory study.

Science.gov (United States)

Thomson, Oliver P; Petty, Nicola J; Moore, Ann P

2014-02-01

There is limited understanding of how osteopaths make decisions in relation to clinical practice. The aim of this research was to construct an explanatory theory of the clinical decision-making and therapeutic approaches of experienced osteopaths in the UK. Twelve UK registered osteopaths participated in this constructivist grounded theory qualitative study. Purposive and theoretical sampling was used to select participants. Data was collected using semi-structured interviews which were audio-recorded and transcribed. As the study approached theoretical sufficiency, participants were observed and video-recorded during a patient appointment, which was followed by a video-prompted interview. Constant comparative analysis was used to analyse and code data. Data analysis resulted in the construction of three qualitatively different therapeutic approaches which characterised participants and their clinical practice, termed; Treater, Communicator and Educator. Participants' therapeutic approach influenced their approach to clinical decision-making, the level of patient involvement, their interaction with patients, and therapeutic goals. Participants' overall conception of practice lay on a continuum ranging from technical rationality to professional artistry, and contributed to their therapeutic approach. A range of factors were identified which influenced participants' conception of practice. The findings indicate that there is variation in osteopaths' therapeutic approaches to practice and clinical decision-making, which are influenced by their overall conception of practice. This study provides the first explanatory theory of the clinical decision-making and therapeutic approaches of osteopaths. Copyright © 2013 Elsevier Ltd. All rights reserved.

Clinical evaluation of guidelines and two-test approach for lyme disease

NARCIS (Netherlands)

Blaauw, A. A.; van Loon, A. M.; Schellekens, J. F.; Bijlsma, J. W.

1999-01-01

The diagnosis of Lyme disease should be based on objective clinical signs and symptoms. In a clinical study, we have evaluated whether the recommended two-step approach for serodiagnosis of Lyme disease is useful in daily clinical practice and can influence clinical decision making. The signs and

A machine learning approach to identify clinical trials involving nanodrugs and nanodevices from ClinicalTrials.gov.

Directory of Open Access Journals (Sweden)

Diana de la Iglesia

Full Text Available Clinical Trials (CTs are essential for bridging the gap between experimental research on new drugs and their clinical application. Just like CTs for traditional drugs and biologics have helped accelerate the translation of biomedical findings into medical practice, CTs for nanodrugs and nanodevices could advance novel nanomaterials as agents for diagnosis and therapy. Although there is publicly available information about nanomedicine-related CTs, the online archiving of this information is carried out without adhering to criteria that discriminate between studies involving nanomaterials or nanotechnology-based processes (nano, and CTs that do not involve nanotechnology (non-nano. Finding out whether nanodrugs and nanodevices were involved in a study from CT summaries alone is a challenging task. At the time of writing, CTs archived in the well-known online registry ClinicalTrials.gov are not easily told apart as to whether they are nano or non-nano CTs-even when performed by domain experts, due to the lack of both a common definition for nanotechnology and of standards for reporting nanomedical experiments and results.We propose a supervised learning approach for classifying CT summaries from ClinicalTrials.gov according to whether they fall into the nano or the non-nano categories. Our method involves several stages: i extraction and manual annotation of CTs as nano vs. non-nano, ii pre-processing and automatic classification, and iii performance evaluation using several state-of-the-art classifiers under different transformations of the original dataset.The performance of the best automated classifier closely matches that of experts (AUC over 0.95, suggesting that it is feasible to automatically detect the presence of nanotechnology products in CT summaries with a high degree of accuracy. This can significantly speed up the process of finding whether reports on ClinicalTrials.gov might be relevant to a particular nanoparticle or nanodevice

A machine learning approach to identify clinical trials involving nanodrugs and nanodevices from ClinicalTrials.gov.

Science.gov (United States)

de la Iglesia, Diana; García-Remesal, Miguel; Anguita, Alberto; Muñoz-Mármol, Miguel; Kulikowski, Casimir; Maojo, Víctor

2014-01-01

Clinical Trials (CTs) are essential for bridging the gap between experimental research on new drugs and their clinical application. Just like CTs for traditional drugs and biologics have helped accelerate the translation of biomedical findings into medical practice, CTs for nanodrugs and nanodevices could advance novel nanomaterials as agents for diagnosis and therapy. Although there is publicly available information about nanomedicine-related CTs, the online archiving of this information is carried out without adhering to criteria that discriminate between studies involving nanomaterials or nanotechnology-based processes (nano), and CTs that do not involve nanotechnology (non-nano). Finding out whether nanodrugs and nanodevices were involved in a study from CT summaries alone is a challenging task. At the time of writing, CTs archived in the well-known online registry ClinicalTrials.gov are not easily told apart as to whether they are nano or non-nano CTs-even when performed by domain experts, due to the lack of both a common definition for nanotechnology and of standards for reporting nanomedical experiments and results. We propose a supervised learning approach for classifying CT summaries from ClinicalTrials.gov according to whether they fall into the nano or the non-nano categories. Our method involves several stages: i) extraction and manual annotation of CTs as nano vs. non-nano, ii) pre-processing and automatic classification, and iii) performance evaluation using several state-of-the-art classifiers under different transformations of the original dataset. The performance of the best automated classifier closely matches that of experts (AUC over 0.95), suggesting that it is feasible to automatically detect the presence of nanotechnology products in CT summaries with a high degree of accuracy. This can significantly speed up the process of finding whether reports on ClinicalTrials.gov might be relevant to a particular nanoparticle or nanodevice, which is

Deep round window insertion versus standard approach in cochlear implant surgery.

Science.gov (United States)

Nordfalk, Karl Fredrik; Rasmussen, Kjell; Bunne, Marie; Jablonski, Greg Eigner

2016-01-01

The aim of this study was to compare the outcomes of vestibular tests and the residual hearing of patients who have undergone full insertion cochlear implant surgery using the round window approach with a hearing preservation protocol (RW-HP) or the standard cochleostomy approach (SCA) without hearing preservation. A prospective study of 34 adults who underwent unilateral cochlear implantation was carried out. One group was operated using the RW-HP (n = 17) approach with Med-El +Flex(SOFT) electrode array with full insertion, while the control group underwent a more conventional SCA surgery (n = 17) with shorter perimodiolar electrodes. Assessments of residual hearing, cervical vestibular-evoked myogenic potentials (cVEMP), videonystagmography, subjective visual vertical/horizontal (SVH/SVV) were performed before and after surgery. There was a significantly (p < 0.05) greater number of subjects who exhibited complete or partial hearing preservation in the deep insertion RW-HP group (9/17) compared to the SCA group (2/15). A higher degree of vestibular loss but a lower degree of vertigo symptoms could be seen in the RW-HP group, but the differences were not statistically significant. It is possible to preserve residual hearing to a certain extent also with deep insertion. Full insertion with hearing preservation was less harmful to residual hearing particularly at 125 Hz (p < 0.05), than was the standard cochleostomy approach.

Development and implementation of a clinical pathway approach to simulation-based training for foregut surgery.

Science.gov (United States)

Miyasaka, Kiyoyuki W; Buchholz, Joseph; LaMarra, Denise; Karakousis, Giorgos C; Aggarwal, Rajesh

2015-01-01

Contemporary demands on resident education call for integration of simulation. We designed and implemented a simulation-based curriculum for Post Graduate Year 1 surgery residents to teach technical and nontechnical skills within a clinical pathway approach for a foregut surgery patient, from outpatient visit through surgery and postoperative follow-up. The 3-day curriculum for groups of 6 residents comprises a combination of standardized patient encounters, didactic sessions, and hands-on training. The curriculum is underpinned by a summative simulation "pathway" repeated on days 1 and 3. The "pathway" is a series of simulated preoperative, intraoperative, and postoperative encounters in following up a single patient through a disease process. The resident sees a standardized patient in the clinic presenting with distal gastric cancer and then enters an operating room to perform a gastrojejunostomy on a porcine tissue model. Finally, the resident engages in a simulated postoperative visit. All encounters are rated by faculty members and the residents themselves, using standardized assessment forms endorsed by the American Board of Surgery. A total of 18 first-year residents underwent this curriculum. Faculty ratings of overall operative performance significantly improved following the 3-day module. Ratings of preoperative and postoperative performance were not significantly changed in 3 days. Resident self-ratings significantly improved for all encounters assessed, as did reported confidence in meeting the defined learning objectives. Conventional surgical simulation training focuses on technical skills in isolation. Our novel "pathway" curriculum targets an important gap in training methodologies by placing both technical and nontechnical skills in their clinical context as part of managing a surgical patient. Results indicate consistent improvements in assessments of performance as well as confidence and support its continued usage to educate surgery residents

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.

IAEA safety standards and approach to safety of advanced reactors

International Nuclear Information System (INIS)

Gasparini, M.

2004-01-01

The paper presents an overview of the IAEA safety standards including their overall structure and purpose. A detailed presentation is devoted to the general approach to safety that is embodied in the current safety requirements for the design of nuclear power plants. A safety approach is proposed for the future. This approach can be used as reference for a safe design, for safety assessment and for the preparation of the safety requirements. The method proposes an integration of deterministic and risk informed concepts in the general frame of a generalized concept of safety goals and defence in depth. This methodology may provide a useful tool for the preparation of safety requirements for the design and operation of any kind of reactor including small and medium sized reactors with innovative safety features.(author)

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

A clinical approach to Lyme disease.

Science.gov (United States)

Nadelman, R B; Wormser, G P

1990-05-01

Lyme disease (also known as Lyme borreliosis) is an emerging, newly described infectious disease with diverse clinical manifestations. The disease is caused by the spirochetal agent Borrelia burgdorferi, which is transmitted to humans by the bite of certain species of Ixodes ticks harboring the organism. The most readily identifiable clinical feature is the distinctive skin lesion, erythema migrans. If recently infected patients go untreated, approximately 15% will develop neurologic conditions (most commonly facial nerve palsy), 8% will develop myocarditis (typically with heart block), and 60% will develop migratory mono- or pauci-articular arthritis. Diagnosis depends on clinical suspicion, recognition of the characteristic signs and symptoms, and appropriate testing for antibody to B. burgdorferi. Serology for Lyme disease, although in need of better standardization, is most useful in diagnosing patients with manifestations of Lyme disease other than erythema migrans. All manifestations of Lyme disease are potentially treatable with either a beta-lactam antibiotic (for instance penicillin, amoxicillin, or ceftriaxone) or a tetracycline preparation. However, the optimal antimicrobial regimen, including choice of drug, drug dose, route of administration, and length of therapy, is unknown. Other important areas for future research include Ixodes biology and control, improved laboratory tests for diagnosis and for assessing response to therapy, and vaccine development.

Understanding clinical reasoning in osteopathy: a qualitative research approach.

Science.gov (United States)

Grace, Sandra; Orrock, Paul; Vaughan, Brett; Blaich, Raymond; Coutts, Rosanne

2016-01-01

Clinical reasoning has been described as a process that draws heavily on the knowledge, skills and attributes that are particular to each health profession. However, the clinical reasoning processes of practitioners of different disciplines demonstrate many similarities, including hypothesis generation and reflective practice. The aim of this study was to understand clinical reasoning in osteopathy from the perspective of osteopathic clinical educators and the extent to which it was similar or different from clinical reasoning in other health professions. This study was informed by constructivist grounded theory. Participants were clinical educators in osteopathic teaching institutions in Australia, New Zealand and the UK. Focus groups and written critical reflections provided a rich data set. Data were analysed using constant comparison to develop inductive categories. According to participants, clinical reasoning in osteopathy is different from clinical reasoning in other health professions. Osteopaths use a two-phase approach: an initial biomedical screen for serious pathology, followed by use of osteopathic reasoning models that are based on the relationship between structure and function in the human body. Clinical reasoning in osteopathy was also described as occurring in a number of contexts (e.g. patient, practitioner and community) and drawing on a range of metaskills (e.g. hypothesis generation and reflexivity) that have been described in other health professions. The use of diagnostic reasoning models that are based on the relationship between structure and function in the human body differentiated clinical reasoning in osteopathy. These models were not used to name a medical condition but rather to guide the selection of treatment approaches. If confirmed by further research that clinical reasoning in osteopathy is distinct from clinical reasoning in other health professions, then osteopaths may have a unique perspective to bring to multidisciplinary

A work-based learning approach for clinical support workers on mental health inpatient wards.

Science.gov (United States)

Kemp, Philip; Gilding, Moorene; Seewooruttun, Khooseal; Walsh, Hannah

2016-09-14

Background With a rise in the number of unqualified staff providing health and social care, and reports raising concerns about the quality of care provided, there is a need to address the learning needs of clinical support workers. This article describes a qualitative evaluation of a service improvement project that involved a work-based learning approach for clinical support workers on mental health inpatient wards. Aim To investigate and identify insights in relation to the content and process of learning using a work-based learning approach for clinical support workers. Method This was a qualitative evaluation of a service improvement project involving 25 clinical support workers at the seven mental health inpatient units in South London and Maudsley NHS Foundation Trust. Three clinical skills tutors were appointed to develop, implement and evaluate the work-based learning approach. Four sources of data were used to evaluate this approach, including reflective journals, qualitative responses to questionnaires, three focus groups involving the clinical support workers and a group interview involving the clinical skills tutors. Data were analysed using thematic analysis. Findings The work-based learning approach was highly valued by the clinical support workers and enhanced learning in practice. Face-to-face learning in practice helped the clinical support workers to develop practice skills and reflective learning skills. Insights relating to the role of clinical support workers were also identified, including the benefits of face-to-face supervision in practice, particularly in relation to the interpersonal aspects of care. Conclusion A work-based learning approach has the potential to enhance care delivery by meeting the learning needs of clinical support workers and enabling them to apply learning to practice. Care providers should consider how the work-based learning approach can be used on a systematic, organisation-wide basis in the context of budgetary

A Principles-Based Approach to Teaching International Financial Reporting Standards (IFRS)

Science.gov (United States)

Persons, Obeua

2014-01-01

This article discusses the principles-based approach that emphasizes a "why" question by using the International Accounting Standards Board (IASB) "Conceptual Framework for Financial Reporting" to question and understand the basis for specific differences between IFRS and U.S. generally accepted accounting principles (U.S.…

Standardization of 8-color flow cytometry across different flow cytometer instruments: A feasibility study in clinical laboratories in Switzerland.

Science.gov (United States)

Glier, Hana; Heijnen, Ingmar; Hauwel, Mathieu; Dirks, Jan; Quarroz, Stéphane; Lehmann, Thomas; Rovo, Alicia; Arn, Kornelius; Matthes, Thomas; Hogan, Cassandra; Keller, Peter; Dudkiewicz, Ewa; Stüssi, Georg; Fernandez, Paula

2017-07-29

The EuroFlow Consortium developed a fully standardized flow cytometric approach from instrument settings, through antibody panel, reagents and sample preparation protocols, to data acquisition and analysis. The Swiss Cytometry Society (SCS) promoted a study to evaluate the feasibility of using such standardized measurements of 8-color data across two different flow cytometry platforms - Becton Dickinson (BD) FACSCanto II and Beckman Coulter (BC) Navios, aiming at increasing reproducibility and inter-laboratory comparability of immunophenotypic data in clinical laboratories in Switzerland. The study was performed in two phases, i.e. a learning phase (round 1) and an analytical phase (rounds 2 and 3) consisting of a total of three rounds. Overall, 10 laboratories using BD FACSCanto II (n=6) or BC Navios (n=4) flow cytometers participated. Each laboratory measured peripheral blood samples from healthy donors stained with a uniform antibody panel of reagents - EuroFlow Lymphoid Screening Tube (LST) - applying the EuroFlow standardized protocols for instrument setup and sample preparation (www.EuroFlow.org). All data files were analyzed centrally and median fluorescence intensity (MedFI) values for individual markers on defined lymphocyte subsets were recorded; variability from reference MedFI values was assessed using performance scores. Data troubleshooting and discussion of the results with the participants followed after each round at SCS meetings. The results of the learning phase demonstrated that standardized instrument setup and data acquisition are feasible in routine clinical laboratories without previous experience with EuroFlow. During the analytical phase, highly comparable data were obtained at the different laboratories using either BD FACSCanto II or BC Navios. The coefficient of variation of MedFI for 7 of 11 markers performed repeatedly below 30%. In the last study round, 89% of participants scored over 90% MedFI values within the acceptance criteria

A Risk and Standards Based Approach to Quality Assurance in Australia's Diverse Higher Education Sector

Science.gov (United States)

Australian Government Tertiary Education Quality and Standards Agency, 2015

2015-01-01

The Australian Government Tertiary Education Quality and Standards Agency's (TEQSA's) role is to assure that quality standards are being met by all registered higher education providers. This paper explains how TEQSA's risk-based approach to assuring higher education standards is applied in broad terms to a diverse sector. This explanation is…

Blended Learning zur integrierten und standardisierten Vermittlung klinischer Untersuchungstechniken: Das KliFO-Projekt [A blended learning approach for the integrated and standardized teaching of clinical skills: The CliSO project

Directory of Open Access Journals (Sweden)

Brüchner, Kirsten

2009-02-01

Full Text Available [english] Objective: The medical faculties of LMU Munich and CAU Kiel have developed a joint blended learning concept for computer-based learning and practical training of clinical skills: "CliSO – Clinical Skills Online" (. CliSO is implemented in their core curricula with the intention to foster students’ medical examination skills at the preclinical and clinical level. Methods: Both partners contributed their special competencies in the fields of case-based learning (Munich: CASUS e-learning platform and systematic learning (Kiel: Nickels e-learning platform. The didactic concept comprises the integration of theory and practice. It combines the standardized teaching of the following three components: Clinical skills are trained and reviewed in face-to-face courses. In the e-learning environment, the well-directed combination of case-based and systematic learning together with the chosen diversity of media (video, audio, animation facilitates situated learning as well as the intelligible presentation of clinical skills and their biomedical background. Both faculties agreed on joint learning objectives and standards. Results and prospects: It was possible to apply the concept to the different target groups at both faculties (first and second study phases and the differently designed face-to-face courses (Kiel: students examine each other; Munich: patients are examined in addition. Evaluations and studies confirmed the success of this approach, so that a transfer of the concept to other faculties is intended. [german] Zielsetzung: Mit „KliFO – Klinische Fertigkeiten Online“ ( haben die Medizinischen Fakultäten der LMU München und der CAU Kiel ein gemeinsames Blended Learning-Konzept zum computergestützten Lernen und praktischen Trainieren von klinischen Untersuchungstechniken entwickelt und in Pflichtveranstaltungen der Curricula integriert. Ziele sind die Verbesserung der Vor- und Nachbereitung von Untersuchungskursen im

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.)

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

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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.

Medical imaging in clinical applications algorithmic and computer-based approaches

CERN Document Server

Bhateja, Vikrant; Hassanien, Aboul

2016-01-01

This volume comprises of 21 selected chapters, including two overview chapters devoted to abdominal imaging in clinical applications supported computer aided diagnosis approaches as well as different techniques for solving the pectoral muscle extraction problem in the preprocessing part of the CAD systems for detecting breast cancer in its early stage using digital mammograms. The aim of this book is to stimulate further research in medical imaging applications based algorithmic and computer based approaches and utilize them in real-world clinical applications. The book is divided into four parts, Part-I: Clinical Applications of Medical Imaging, Part-II: Classification and clustering, Part-III: Computer Aided Diagnosis (CAD) Tools and Case Studies and Part-IV: Bio-inspiring based Computer Aided diagnosis techniques. .

The Johns Hopkins RTR Consortium: A Collaborative Approach to Advance Translational Science and Standardize Clinical Monitoring of Restorative Transplantation - Immunomodulation and Tolerance Induction after VCA using Biologic Agent (cTLA4-Ig) and Donor Bone Marrow Cells

Science.gov (United States)

2014-10-01

Standardize Clinical Monitoring of Restorative Transplantation – Immunomodulation and Tolerance Induction after VCA using Biologic Agent (cTLA4-Ig) and...Translational Science and Standardize Clinical Monitoring of Restorative Transplantation – Immunomodulation and Tolerance Induction after VCA using Biologic...wider application. Thus the purpose of this project is to develop novel clinically relevant regimens for immunomodulation and tolerance induction after

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

Developing clinical strength-of-evidence approach to define HIV-associated malignancies for cancer registration in Kenya.

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Anne Korir

Full Text Available Sub-Saharan Africa cancer registries are beset by an increasing cancer burden further exacerbated by the AIDS epidemic where there are limited capabilities for cancer-AIDS match co-registration. We undertook a pilot study based on a "strength-of-evidence" approach using clinical data that is abstracted at the time of cancer registration for purposes of linking cancer diagnosis to AIDS diagnosis.The standard Nairobi Cancer Registry form was modified for registrars to abstract the following clinical data from medical records regarding HIV infection/AIDS in a hierarchal approach at time of cancer registration from highest-to-lowest strength-of-evidence: 1 documentation of positive HIV serology; 2 antiretroviral drug prescription; 3 CD4+ lymphocyte count; and 4 WHO HIV clinical stage or immune suppression syndrome (ISS, which is Kenyan terminology for AIDS. Between August 1 and October 31, 2011 a total of 1,200 cancer cases were registered. Of these, 171 cases (14.3% met clinical strength-of-evidence criteria for association with HIV infection/AIDS; 69% (118 cases were tumor types with known HIV association - Kaposi's sarcoma, cervical cancer, non-Hodgkin's and Hodgkin's lymphoma, and conjunctiva carcinoma and 31% (53 were consistent with non-AIDS defining cancers. Verifiable positive HIV serology was identified in 47 (27% cases for an absolute seroprevalence rate of 4% among the cancer registered cases with an upper boundary of 14% among those meeting at least one of strength-of-evidence criteria.This pilot demonstration of a hierarchal, clinical strength-of-evidence approach for cancer-AIDS registration in Kenya establishes feasibility, is readily adaptable, pragmatic, and does not require additional resources for critically under staffed cancer registries. Cancer is an emerging public health challenge, and African nations need to develop well designed population-based studies in order to better define the impact and spectrum of malignant disease

Factors influencing the approaches to studying of preclinical and clinical students and postgraduate trainees

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Samarasekera Dharmabandu N

2011-05-01

Full Text Available Abstract Background Students can be classified into three categories depending on their approaches to studying; namely, deep approach (DA, strategic approach (SA and surface apathetic or superficial approach (SAA. The aim of this study was to identify factors affecting the approaches to studying among Sri Lankan medical undergraduates and post graduate trainees and to analyze the change in the pattern of study skills with time and experience. Method Pre-clinical and clinical students of the Faculty of Medicine, University of Colombo and postgraduate trainees in Surgery at the National Hospital of Sri Lanka were invited to complete the Approaches and Study Skills Inventory for Students (ASSIST questionnaire. Results A total of 187 pre clinical (M: F = 96:91, 124 clinical (M: F = 61:63 and 53 post graduate trainees (M: F = 50:3 participated in the study. Approaches of male and female students were similar. SA was significantly affected by age among the preclinical students (p = 0.01, but not in other groups. Among pre-clinical students, males preferred a teacher who supported understanding (p = 0.04 but females preferred a passive transmission of information (p Conclusion Different factors affect the approach to studying in different groups but these explain only a small fraction of the variance observed.

Narrative Interest Standard: A Novel Approach to Surrogate Decision-Making for People With Dementia.

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Wilkins, James M

2017-06-17

Dementia is a common neurodegenerative process that can significantly impair decision-making capacity as the disease progresses. When a person is found to lack capacity to make a decision, a surrogate decision-maker is generally sought to aid in decision-making. Typical bases for surrogate decision-making include the substituted judgment standard and the best interest standard. Given the heterogeneous and progressive course of dementia, however, these standards for surrogate decision-making are often insufficient in providing guidance for the decision-making for a person with dementia, escalating the likelihood of conflict in these decisions. In this article, the narrative interest standard is presented as a novel and more appropriate approach to surrogate decision-making for people with dementia. Through case presentation and ethical analysis, the standard mechanisms for surrogate decision-making for people with dementia are reviewed and critiqued. The narrative interest standard is then introduced and discussed as a dementia-specific model for surrogate decision-making. Through incorporation of elements of a best interest standard in focusing on the current benefit-burden ratio and elements of narrative to provide context, history, and flexibility for values and preferences that may change over time, the narrative interest standard allows for elaboration of an enriched context for surrogate decision-making for people with dementia. More importantly, however, a narrative approach encourages the direct contribution from people with dementia in authoring the story of what matters to them in their lives.

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

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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

Using Narratives to Develop Standards for Leaders: Applying an Innovative Approach in Western Australia

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Wildy, Helen; Pepper, Coral

2005-01-01

Dissatisfaction with long lists of duties as substitutes for standards led to the innovative application of narratives as an alternative approach to the generation and use of standards for school leaders. This paper describes research conducted over nearly a decade in collaboration with the state education authority in Western Australia,…

Transformation of standardized clinical models based on OWL technologies: from CEM to OpenEHR archetypes.

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Legaz-García, María del Carmen; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás; Chute, Christopher G; Tao, Cui

2015-05-01

The semantic interoperability of electronic healthcare records (EHRs) systems is a major challenge in the medical informatics area. International initiatives pursue the use of semantically interoperable clinical models, and ontologies have frequently been used in semantic interoperability efforts. The objective of this paper is to propose a generic, ontology-based, flexible approach for supporting the automatic transformation of clinical models, which is illustrated for the transformation of Clinical Element Models (CEMs) into openEHR archetypes. Our transformation method exploits the fact that the information models of the most relevant EHR specifications are available in the Web Ontology Language (OWL). The transformation approach is based on defining mappings between those ontological structures. We propose a way in which CEM entities can be transformed into openEHR by using transformation templates and OWL as common representation formalism. The transformation architecture exploits the reasoning and inferencing capabilities of OWL technologies. We have devised a generic, flexible approach for the transformation of clinical models, implemented for the unidirectional transformation from CEM to openEHR, a series of reusable transformation templates, a proof-of-concept implementation, and a set of openEHR archetypes that validate the methodological approach. We have been able to transform CEM into archetypes in an automatic, flexible, reusable transformation approach that could be extended to other clinical model specifications. We exploit the potential of OWL technologies for supporting the transformation process. We believe that our approach could be useful for international efforts in the area of semantic interoperability of EHR systems. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

European standards and approaches to EMC in nuclear power plants

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Bardsley, D.J.; Dillingham, S.R.; McMinn, K. [AEA Technology, Dorset (United Kingdom)

1995-04-01

Electromagnetic Interference (EMI) arising from a wide range of sources can threaten nuclear power plant operation. The need for measures to mitigate its effects have long been recognised although there are difference in approaches worldwide. The US industry approaches the problem by comprehensive site surveys defining an envelope of emissions for the environmental whilst the UK nuclear industry defined many years ago generic levels which cover power station environments. Moves to standardisation within the European community have led to slight changes in UK approach, in particular how large systems can be tested. The tests undertaken on UK nuclear plant include tests for immunity to conducted as well as radiated interference. Similar tests are also performed elsewhere in Europe but are not, to the authors` knowledge, commonly undertaken in the USA. Currently work is proceeding on draft international standards under the auspices of the IEC.

Professional approaches in clinical judgements among senior and junior doctors: implications for medical education

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Pilhammar Ewa

2009-05-01

Full Text Available Abstract Background Clinical experience has traditionally been highly valued in medical education and clinical healthcare. On account of its multi-faceted nature, clinical experience is mostly difficult to articulate, and is mainly expressed in clinical situations as professional approaches. Due to retirement, hospitals in Scandinavia will soon face a substantial decrease in the number of senior specialist doctors, and it has been discussed whether healthcare will suffer an immense loss of experienced-based knowledge when this senior group leaves the organization. Both senior specialists and junior colleagues are often involved in clinical education, but the way in which these two groups vary in professional approaches and contributions to clinical education has not been so well described. Cognitive psychology has contributed to the understanding of how experience may influence professional approaches, but such studies have not included the effect of differences in position and responsibilities that junior and senior doctors hold in clinical healthcare. In the light of the discussion above, it is essential to describe the professional approaches of senior doctors in relation to those of their junior colleagues. This study therefore aims to describe and compare the professional approaches of junior and senior doctors when making clinical judgements. Methods Critical incident technique was used in interviews with nine senior doctors and nine junior doctors in internal medicine. The interviews were subjected to qualitative content analysis. Result Senior and junior doctors expressed a variety of professional approaches in clinical judgement as follows: use of theoretical knowledge, use of prior experience of cases and courses of events, use of ethical and moral values, meeting and communicating with the patient, focusing on available information, relying on their own ability, getting support and guidance from others and being directed by the

Standardized approach for developing probabilistic exposure factor distributions

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Maddalena, Randy L.; McKone, Thomas E.; Sohn, Michael D.

2003-03-01

The effectiveness of a probabilistic risk assessment (PRA) depends critically on the quality of input information that is available to the risk assessor and specifically on the probabilistic exposure factor distributions that are developed and used in the exposure and risk models. Deriving probabilistic distributions for model inputs can be time consuming and subjective. The absence of a standard approach for developing these distributions can result in PRAs that are inconsistent and difficult to review by regulatory agencies. We present an approach that reduces subjectivity in the distribution development process without limiting the flexibility needed to prepare relevant PRAs. The approach requires two steps. First, we analyze data pooled at a population scale to (1) identify the most robust demographic variables within the population for a given exposure factor, (2) partition the population data into subsets based on these variables, and (3) construct archetypal distributions for each subpopulation. Second, we sample from these archetypal distributions according to site- or scenario-specific conditions to simulate exposure factor values and use these values to construct the scenario-specific input distribution. It is envisaged that the archetypal distributions from step 1 will be generally applicable so risk assessors will not have to repeatedly collect and analyze raw data for each new assessment. We demonstrate the approach for two commonly used exposure factors--body weight (BW) and exposure duration (ED)--using data for the U.S. population. For these factors we provide a first set of subpopulation based archetypal distributions along with methodology for using these distributions to construct relevant scenario-specific probabilistic exposure factor distributions.

A new approach for heparin standardization: combination of scanning UV spectroscopy, nuclear magnetic resonance and principal component analysis.

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Marcelo A Lima

Full Text Available The year 2007 was marked by widespread adverse clinical responses to heparin use, leading to a global recall of potentially affected heparin batches in 2008. Several analytical methods have since been developed to detect impurities in heparin preparations; however, many are costly and dependent on instrumentation with only limited accessibility. A method based on a simple UV-scanning assay, combined with principal component analysis (PCA, was developed to detect impurities, such as glycosaminoglycans, other complex polysaccharides and aromatic compounds, in heparin preparations. Results were confirmed by NMR spectroscopy. This approach provides an additional, sensitive tool to determine heparin purity and safety, even when NMR spectroscopy failed, requiring only standard laboratory equipment and computing facilities.

Practical Considerations for Clinical PET/MR Imaging.

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Galgano, Samuel; Viets, Zachary; Fowler, Kathryn; Gore, Lael; Thomas, John V; McNamara, Michelle; McConathy, Jonathan

2018-01-01

Clinical PET/MR imaging is currently performed at a number of centers around the world as part of routine standard of care. This article focuses on issues and considerations for a clinical PET/MR imaging program, focusing on routine standard-of-care studies. Although local factors influence how clinical PET/MR imaging is implemented, the approaches and considerations described here intend to apply to most clinical programs. PET/MR imaging provides many more options than PET/computed tomography with diagnostic advantages for certain clinical applications but with added complexity. A recurring theme is matching the PET/MR imaging protocol to the clinical application to balance diagnostic accuracy with efficiency. Copyright © 2017 Elsevier Inc. All rights reserved.

Secondary use of clinical data: the Vanderbilt approach.

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Danciu, Ioana; Cowan, James D; Basford, Melissa; Wang, Xiaoming; Saip, Alexander; Osgood, Susan; Shirey-Rice, Jana; Kirby, Jacqueline; Harris, Paul A

2014-12-01

The last decade has seen an exponential growth in the quantity of clinical data collected nationwide, triggering an increase in opportunities to reuse the data for biomedical research. The Vanderbilt research data warehouse framework consists of identified and de-identified clinical data repositories, fee-for-service custom services, and tools built atop the data layer to assist researchers across the enterprise. Providing resources dedicated to research initiatives benefits not only the research community, but also clinicians, patients and institutional leadership. This work provides a summary of our approach in the secondary use of clinical data for research domain, including a description of key components and a list of lessons learned, designed to assist others assembling similar services and infrastructure. Copyright © 2014 Elsevier Inc. All rights reserved.

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...

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

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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.

A Standardized Narrative Profile Approach to Self-Reflection and Assessment of Cross-Cultural Communication

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Kyle J Wilby

2017-03-01

Full Text Available Objectives: 1 to explore clinical assessor’s values regarding behaviours related to cultural aspects of care, 2 to generate standardized narrative profiles regarding cultural behavioural outcomes within clinical teaching settings, and 3 to rank order standardized narrative profiles according to performance expectations. Methods: Ten interviews were completed with clinicians to determine values and performance expectations for culturally competent behaviours. Transcripts were produced and coded. Six narrative profiles were developed based on data obtained. Twenty clinicians categorized profiles according to performance expectations and rank ordered. Intraclass correlation coefficients (ICCs determined inter-rater reliability. Clinicians rated usability of profiles in clinical training settings. Results: Eighteen categories were coded with communication, awareness and ability most frequently reported with each ranging from 9.6-11.5% of the utterances. Consensus for categorization of all profiles was achieved at a level of 70% (ICC = 0.837, 95% CI 0.654-0.969. High inter-rater reliability was achieved for rank ordering (ICC = 0.815, 95% CI 0.561 to 0.984. Seventeen (85% clinicians agreed that the profiles would be usable in clinical training settings. Conclusions: Standardized narrative profiles may aid assessment and self-reflection for student performance within culturally diverse interactions. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Research

Patient-controlled encrypted genomic data: an approach to advance clinical genomics

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Trakadis Yannis J

2012-07-01

Full Text Available Abstract Background The revolution in DNA sequencing technologies over the past decade has made it feasible to sequence an individual’s whole genome at a relatively low cost. The potential value of the information generated by genomic technologies for medicine and society is enormous. However, in order for exome sequencing, and eventually whole genome sequencing, to be implemented clinically, a number of major challenges need to be overcome. For instance, obtaining meaningful informed-consent, managing incidental findings and the great volume of data generated (including multiple findings with uncertain clinical significance, re-interpreting the genomic data and providing additional counselling to patients as genetic knowledge evolves are issues that need to be addressed. It appears that medical genetics is shifting from the present “phenotype-first” medical model to a “data-first” model which leads to multiple complexities. Discussion This manuscript discusses the different challenges associated with integrating genomic technologies into clinical practice and describes a “phenotype-first” approach, namely, “Individualized Mutation-weighed Phenotype Search”, and its benefits. The proposed approach allows for a more efficient prioritization of the genes to be tested in a clinical lab based on both the patient’s phenotype and his/her entire genomic data. It simplifies “informed-consent” for clinical use of genomic technologies and helps to protect the patient’s autonomy and privacy. Overall, this approach could potentially render widespread use of genomic technologies, in the immediate future, practical, ethical and clinically useful. Summary The “Individualized Mutation-weighed Phenotype Search” approach allows for an incremental integration of genomic technologies into clinical practice. It ensures that we do not over-medicalize genomic data but, rather, continue our current medical model which is based on serving

Epileptic Seizures Versus Syncope: Pathophysiology and Clinical Approach

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Marios Charalambous

2017-02-01

Full Text Available Generalised epileptic seizures and syncope are two syndromes with similar clinical manifestation and their differentiation can be quite challenging. The aim of this review is to use an evidence-based approach in differentiating these two syndromes through the comprehension of the pathophysiological mechanisms involved and their clinical signs. Both syndromes affect regions of the forebrain and consciousness level, although, different mechanisms are involved. Syncope is a paroxysmal event secondary to a short-term decrease in cerebral perfusion, oxygenation or essential nutrients delivery. Generalised epileptic seizure activity is defined as the clinical manifestation of transient paroxysmal disturbances in brain function secondary to an imbalance between excitatory and inhibitory neurotransmitters. Clinical criteria, including precipitating events, clinical signs preceding, during and following the episodes and event duration, can be used to differentiate the two syndromes. Although these criteria might be useful for the practitioner, definite conclusions should be precluded due to the lack of original research articles and weak evidence on this specific field.Application: The review might be a useful tool for the general practitioner and clinical scientist as it will aid towards the differentiation of two syndromes, i.e. generalised epileptic seizures and syncope, with similar clinical presentation.

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...

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

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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.

Developing a Clinical Approach to Air Pollution and Cardiovascular Health.

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Hadley, Michael B; Baumgartner, Jill; Vedanthan, Rajesh

2018-02-13

Nearly 3 billion people are exposed to household air pollution emitted from inefficient cooking and heating stoves, and almost the entire global population is exposed to detectable levels of outdoor air pollution from traffic, industry, and other sources. Over 3 million people die annually of ischemic heart disease or stroke attributed to air pollution, more than from traditional cardiac risk factors such as obesity, diabetes mellitus, or smoking. Clinicians have a role to play in reducing the burden of pollution-attributable cardiovascular disease. However, there currently exists no clear clinical approach to this problem. Here, we provide a blueprint for an evidence-based clinical approach to assessing and mitigating cardiovascular risk from exposure to air pollution. We begin with a discussion of the global burden of pollution-attributable cardiovascular disease, including a review of the mechanisms by which particulate matter air pollution leads to cardiovascular outcomes. Next, we offer a simple patient-screening tool using known risk factors for pollution exposure. We then discuss approaches to quantifying air pollution exposures and cardiovascular risk, including the development of risk maps for clinical catchment areas. We review a collection of interventions for household and outdoor air pollution, which clinicians can tailor to patients and populations at risk. Finally, we identify future research needed to quantify pollution exposures and validate clinical interventions. Overall, we demonstrate that clinicians can be empowered to mitigate the global burden of cardiovascular disease attributable to air pollution. © 2018 American Heart Association, Inc.

Interim analysis: A rational approach of decision making in clinical trial.

Science.gov (United States)

Kumar, Amal; Chakraborty, Bhaswat S

2016-01-01

Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.

Interim analysis: A rational approach of decision making in clinical trial

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Amal Kumar

2016-01-01

Full Text Available Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.

Clinical and radiological instability following standard fenestration discectomy

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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.

77 FR 63763 - Regulatory Capital Rules: Standardized Approach for Risk-Weighted Assets; Market Discipline and...

Science.gov (United States)

2012-10-17

... BCBS in 2006 and 2009, as well as other proposals set forth in consultative papers of the BCBS. Section... provided in this Federal Register document, which describes the economic impact of the Standardized... in recent consultative papers of the BCBS.\\2\\ In the Standardized Approach NPR, the agencies also...

A novel approach to generating CER hypotheses based on mining clinical data.

Science.gov (United States)

Zhang, Shuo; Li, Lin; Yu, Yiqin; Sun, Xingzhi; Xu, Linhao; Zhao, Wei; Teng, Xiaofei; Pan, Yue

2013-01-01

Comparative effectiveness research (CER) is a scientific method of investigating the effectiveness of alternative intervention methods. In a CER study, clinical researchers typically start with a CER hypothesis, and aim to evaluate it by applying a series of medical statistical methods. Traditionally, the CER hypotheses are defined manually by clinical researchers. This makes the task of hypothesis generation very time-consuming and the quality of hypothesis heavily dependent on the researchers' skills. Recently, with more electronic medical data being collected, it is highly promising to apply the computerized method for discovering CER hypotheses from clinical data sets. In this poster, we proposes a novel approach to automatically generating CER hypotheses based on mining clinical data, and presents a case study showing that the approach can facilitate clinical researchers to identify potentially valuable hypotheses and eventually define high quality CER studies.

Validation by simulation of a clinical trial model using the standardized mean and variance criteria.

Science.gov (United States)

Abbas, Ismail; Rovira, Joan; Casanovas, Josep

2006-12-01

To develop and validate a model of a clinical trial that evaluates the changes in cholesterol level as a surrogate marker for lipodystrophy in HIV subjects under alternative antiretroviral regimes, i.e., treatment with Protease Inhibitors vs. a combination of nevirapine and other antiretroviral drugs. Five simulation models were developed based on different assumptions, on treatment variability and pattern of cholesterol reduction over time. The last recorded cholesterol level, the difference from the baseline, the average difference from the baseline and level evolution, are the considered endpoints. Specific validation criteria based on a 10% minus or plus standardized distance in means and variances were used to compare the real and the simulated data. The validity criterion was met by all models for considered endpoints. However, only two models met the validity criterion when all endpoints were considered. The model based on the assumption that within-subjects variability of cholesterol levels changes over time is the one that minimizes the validity criterion, standardized distance equal to or less than 1% minus or plus. Simulation is a useful technique for calibration, estimation, and evaluation of models, which allows us to relax the often overly restrictive assumptions regarding parameters required by analytical approaches. The validity criterion can also be used to select the preferred model for design optimization, until additional data are obtained allowing an external validation of the model.

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.

Planned change or emergent change implementation approach and nurses' professional clinical autonomy.

Science.gov (United States)

Luiking, Marie-Louise; Aarts, Leon; Bras, Leo; Grypdonck, Maria; van Linge, Roland

2017-11-01

Nurses' clinical autonomy is considered important for patients' outcome and influenced by the implementation approach of innovations. Emergent change approach with participation in the implementation process is thought to increase clinical autonomy. Planned change approach without this participation is thought not to increase clinical autonomy. Evidence of these effects on clinical autonomy is however limited. To examine the changes in clinical autonomy and in personal norms and values for a planned change and emergent change implementation of an innovation, e.g. intensive insulin therapy. Prospective comparative study with two geographically separated nurses' teams on one intensive care unit (ICU), randomly assigned to the experimental conditions. Data were collected from March 2008 to January 2009. Pre-existing differences in perception of team and innovation characteristics were excluded using instruments based on the innovation contingency model. The Nursing Activity Scale was used to measure clinical autonomy. The Personal Values and Norms instrument was used to assess orientation towards nursing activities and the Team Learning Processes instrument to assess learning as a team. Pre-implementation the measurements did not differ. Post-implementation, clinical autonomy was increased in the emergent change team and decreased in the planned change team. The Personal Values and Norms instrument showed in the emergent change team a decreased hierarchic score and increased developmental and rational scores. In the planned change team the hierarchical and group scores were increased. Learning as a team did not differ between the teams. In both teams there was a change in clinical autonomy and orientation towards nursing activities, in line with the experimental conditions. Emergent change implementation resulted in more clinical autonomy than planned change implementation. If an innovation requires the nurses to make their own clinical decisions, an emergent change

The uses and implications of standards in general practice consultations

DEFF Research Database (Denmark)

Lippert, Maria Laura; Reventlow, Susanne; Kousgaard, Marius Brostrøm

2017-01-01

Quality standards play an increasingly important role in primary care through their inscription in various technologies for improving professional practice. While ‘hard’ biomedical standards have been the most common and debated, current quality development initiatives increasingly seek to include...... as manifestations of an inherent conflict between principles of patient-centredness and formal biomedical quality standards. However, this study suggests that standards on the ‘softer’ aspects of care may just as well interfere with a clinical approach relying on situated and attentive interactions with patients....

A standardized approach for determining radiological sabotage targets

International Nuclear Information System (INIS)

Gardner, B.H.; Snell, M.K.

1993-01-01

The US Department of Energy has required radiological sabotage vulnerability assessments to be conducted for years. However, the exact methodology to be used in this type of analysis still remains somewhat elusive. Therefore, there is tremendous variation in the methodologies and assumptions used to determine release levels and doses potentially affecting the health and safety of the public. In some cases, there are three orders of magnitude difference in results for dispersal of similar materials under similar meteorological conditions. To address this issue, the authors have developed an approach to standardizing radiological sabotage target analysis that starts by addressing basic assumptions and then directs the user to some recommended computerized analytical tools. Results from different dispersal codes are also compared in this analysis

Do diabetes-specialty clinics differ in management approach and ...

African Journals Online (AJOL)

Objectives: To evaluate management approach and outcome in two endocrinologist-managed clinics using data on treatment adherence, diabetes specific parameters, prescribed medications and self-management practices among ambulatory type 2 diabetes patients. Opinion on cause(s) and perceived fear about ...

Machine Learning Approaches for Detecting Diabetic Retinopathy from Clinical and Public Health Records.

Science.gov (United States)

Ogunyemi, Omolola; Kermah, Dulcie

2015-01-01

Annual eye examinations are recommended for diabetic patients in order to detect diabetic retinopathy and other eye conditions that arise from diabetes. Medically underserved urban communities in the US have annual screening rates that are much lower than the national average and could benefit from informatics approaches to identify unscreened patients most at risk of developing retinopathy. Using clinical data from urban safety net clinics as well as public health data from the CDC's National Health and Nutrition Examination Survey, we examined different machine learning approaches for predicting retinopathy from clinical or public health data. All datasets utilized exhibited a class imbalance. Classifiers learned on the clinical data were modestly predictive of retinopathy with the best model having an AUC of 0.72, sensitivity of 69.2% and specificity of 55.9%. Classifiers learned on public health data were not predictive of retinopathy. Successful approaches to detecting latent retinopathy using machine learning could help safety net and other clinics identify unscreened patients who are most at risk of developing retinopathy and the use of ensemble classifiers on clinical data shows promise for this purpose.

An integrated approach towards the nutritional assessment of the Sardinian donkey: a tool for clinical nutritionists

Directory of Open Access Journals (Sweden)

Maria Grazia Cappai

2013-05-01

Full Text Available The aims of the current study were to establish: i a species-specific approach for nutritional assessment during clinical checks on Sarda breed adult donkeys, and ii a suitable equation for body weight prediction, which at present is lacking. A total of 18 adult donkeys were sampled and the following criteria were recorded: body weight (BW, body condition score (BCS, muscular mass index (MMI, along with somatometric measures (height at withers; chest girth and metabolic profiles of each individual. The species-specific nutritional assessment based on the integrated approach turned out to correlate significantly (P<0.05 with the body condition score and levels of Na, P and cholesterol in blood. The parametric equation for predicting the BW (y=0.353a+0.443b-7.62, where a= height at withers in cm; b= chest girth in cm closely fit the determined BW, with a standard error of SE=±5 kg BW.

Comparisons of non-destructive examination standards in the framework of fracture mechanics approach

International Nuclear Information System (INIS)

Reale, S.; Corvi, A.

1993-01-01

One of the aims of the various Engineering Standards related to Non-destructive Examination (NDE) is to identify and limit some characteristics of defects in a structure, since the degree of damage of a structure can be associated with these defect characteristics. One way that the damage level can be evaluated is by means of Fracture Mechanics. The objective of the present paper is to compare and identify the differences in the flaw acceptance criteria of national NDE Standards so as to suggest some guidelines for a future common European Standard. This paper examines the Standards adopted in France (RCC-MR), Germany (DIN), Italy (ASME) and the UK (BSI). It concentrates on both ultrasonic and radiographic inspection methods. The flaw acceptance criteria in these standards relating to non-destructive tests performed on a component during manufacturing are compared and evaluated by the Fracture Mechanics CEGB R6 procedure. General guidelines and results supporting the significance of the Fracture Mechanics approach are given. (Author)

An alternative to the standard spatial econometric approaches in hedonic house price models

DEFF Research Database (Denmark)

von Graevenitz, Kathrine; Panduro, Toke Emil

2015-01-01

Omitted, misspecified, or mismeasured spatially varying characteristics are a cause for concern in hedonic house price models. Spatial econometrics or spatial fixed effects have become popular ways of addressing these concerns. We discuss the limitations of standard spatial approaches to hedonic...

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

Developments in statistical evaluation of clinical trials

CERN Document Server

Oud, Johan; Ghidey, Wendimagegn

2014-01-01

This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

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

Clinical approach to a patient with abnormal uterine bleeding

African Journals Online (AJOL)

bleeding, type, appearance, duration, cyclicity and associated ... Clinical approach. In all cases where the main complaint is that of excessive menstrual bleeding, an immediate differentiation must be made between acute severe blood loss and chronic excessive ... management rules can be implemented. In such patients ...

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.

A Swarm Optimization approach for clinical knowledge mining.

Science.gov (United States)

Christopher, J Jabez; Nehemiah, H Khanna; Kannan, A

2015-10-01

Rule-based classification is a typical data mining task that is being used in several medical diagnosis and decision support systems. The rules stored in the rule base have an impact on classification efficiency. Rule sets that are extracted with data mining tools and techniques are optimized using heuristic or meta-heuristic approaches in order to improve the quality of the rule base. In this work, a meta-heuristic approach called Wind-driven Swarm Optimization (WSO) is used. The uniqueness of this work lies in the biological inspiration that underlies the algorithm. WSO uses Jval, a new metric, to evaluate the efficiency of a rule-based classifier. Rules are extracted from decision trees. WSO is used to obtain different permutations and combinations of rules whereby the optimal ruleset that satisfies the requirement of the developer is used for predicting the test data. The performance of various extensions of decision trees, namely, RIPPER, PART, FURIA and Decision Tables are analyzed. The efficiency of WSO is also compared with the traditional Particle Swarm Optimization. Experiments were carried out with six benchmark medical datasets. The traditional C4.5 algorithm yields 62.89% accuracy with 43 rules for liver disorders dataset where as WSO yields 64.60% with 19 rules. For Heart disease dataset, C4.5 is 68.64% accurate with 98 rules where as WSO is 77.8% accurate with 34 rules. The normalized standard deviation for accuracy of PSO and WSO are 0.5921 and 0.5846 respectively. WSO provides accurate and concise rulesets. PSO yields results similar to that of WSO but the novelty of WSO lies in its biological motivation and it is customization for rule base optimization. The trade-off between the prediction accuracy and the size of the rule base is optimized during the design and development of rule-based clinical decision support system. The efficiency of a decision support system relies on the content of the rule base and classification accuracy. Copyright �

Armonización de estándares de calidad para ensayos clínicos. Norma ISO 9001-Guía de Buena Práctica Clínica Harmonization of quality standards for clinical trials. ISO-9001 standard and Guide of Good Clinical Practice

Directory of Open Access Journals (Sweden)

Sandra Álvarez Guerra

2011-09-01

organizations, namely the ISO 9001:2008 that establishes requirements for Quality Management System. The objective of this paper was to determine common elements showing the harmonization among the Good Clinical Practice of the ICH, the Cuban one and the ISO 9001:2008 in order that they can be implemented in the clinical trials. To this end, one study was performed on the Good Clinical Practice of the ICH, the Cuban and the ISO 9001:2008 standards to find out what they had in common in their use for the clinical trials. It was determined that the clients, the suppliers, the process approach, the documentation, the management, the reviews, the style of conducting the research studies and the quality improvement were common aspects for which there are several requirements set by these standards. The aforementioned allowed stating that the joint use of the studied standards in the clinical trial contributes to raise the quality, since there is not a single aspect that reveals any contradiction whatsoever; there are common aspects that make their harmonization and use possible.

Comparison of Australian and American orthodontic clinical approaches towards root resorption.

Science.gov (United States)

Lim, Elaine; Sameshima, Glenn; Petocz, Peter; Darendeliler, Ali

2012-11-01

As part of The Rocky Mountain Travelling Fellowship, a pilot survey was conducted to assess current diagnostic and clinical approaches to the management of orthodontic patients in relation to root resorption. Groups comprising Australians (Sydney, New South Wales) and North Americans (Los Angeles, California), in two stages of their orthodontic careers (post-graduate orthodontic students from the University of Sydney and University of Southern California and qualified practising orthodontists) were asked to complete a questionnaire. The questions examined diagnosis and management approaches related to root resorption used in their clinical practice. Replies demonstrated that there were differences in management depending on operator experience and the country of clinical practice. However, a summarised common approach to orthodontic root resorption comprised (1) the use of an orthopantomogram as a screening diagnostic tool, followed by periapical radiographs for those perceived as 'higher risk' patients, particularly individuals with a history of root resorption; (2) a six monthly radiographic review during treatment; (3) the use of light forces and/or rest periods (discontinuous forces) every two to three months; (4) the extraction of deciduous teeth if permanent successors were erupting ectopically and causing damage to adjacent root structures; and (5) the use of fixed retention after treatment. This project was intended to initiate discussion and form a basis for further investigation into the clinical management of orthodontic root resorption.

Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial.

Science.gov (United States)

Ferrando, Carlos; Soro, Marina; Unzueta, Carmen; Suarez-Sipmann, Fernando; Canet, Jaume; Librero, Julián; Pozo, Natividad; Peiró, Salvador; Llombart, Alicia; León, Irene; India, Inmaculada; Aldecoa, Cesar; Díaz-Cambronero, Oscar; Pestaña, David; Redondo, Francisco J; Garutti, Ignacio; Balust, Jaume; García, Jose I; Ibáñez, Maite; Granell, Manuel; Rodríguez, Aurelio; Gallego, Lucía; de la Matta, Manuel; Gonzalez, Rafael; Brunelli, Andrea; García, Javier; Rovira, Lucas; Barrios, Francisco; Torres, Vicente; Hernández, Samuel; Gracia, Estefanía; Giné, Marta; García, María; García, Nuria; Miguel, Lisset; Sánchez, Sergio; Piñeiro, Patricia; Pujol, Roger; García-Del-Valle, Santiago; Valdivia, José; Hernández, María J; Padrón, Oto; Colás, Ana; Puig, Jaume; Azparren, Gonzalo; Tusman, Gerardo; Villar, Jesús; Belda, Javier

2018-03-01

The effects of individualised perioperative lung-protective ventilation (based on the open-lung approach [OLA]) on postoperative complications is unknown. We aimed to investigate the effects of intraoperative and postoperative ventilatory management in patients scheduled for abdominal surgery, compared with standard protective ventilation. We did this prospective, multicentre, randomised controlled trial in 21 teaching hospitals in Spain. We enrolled patients who were aged 18 years or older, were scheduled to have abdominal surgery with an expected time of longer than 2 h, had intermediate-to-high-risk of developing postoperative pulmonary complications, and who had a body-mass index less than 35 kg/m 2 . Patients were randomly assigned (1:1:1:1) online to receive one of four lung-protective ventilation strategies using low tidal volume plus positive end-expiratory pressure (PEEP): open-lung approach (OLA)-iCPAP (individualised intraoperative ventilation [individualised PEEP after a lung recruitment manoeuvre] plus individualised postoperative continuous positive airway pressure [CPAP]), OLA-CPAP (intraoperative individualised ventilation plus postoperative CPAP), STD-CPAP (standard intraoperative ventilation plus postoperative CPAP), or STD-O 2 (standard intraoperative ventilation plus standard postoperative oxygen therapy). Patients were masked to treatment allocation. Investigators were not masked in the operating and postoperative rooms; after 24 h, data were given to a second investigator who was masked to allocations. The primary outcome was a composite of pulmonary and systemic complications during the first 7 postoperative days. We did the primary analysis using the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02158923. Between Jan 2, 2015, and May 18, 2016, we enrolled 1012 eligible patients. Data were available for 967 patients, whom we included in the final analysis. Risk of pulmonary and systemic

Bridging the Nomothetic and Idiographic Approaches to the Analysis of Clinical Data.

Science.gov (United States)

Beltz, Adriene M; Wright, Aidan G C; Sprague, Briana N; Molenaar, Peter C M

2016-08-01

The nomothetic approach (i.e., the study of interindividual variation) dominates analyses of clinical data, even though its assumption of homogeneity across people and time is often violated. The idiographic approach (i.e., the study of intraindividual variation) is best suited for analyses of heterogeneous clinical data, but its person-specific methods and results have been criticized as unwieldy. Group iterative multiple model estimation (GIMME) combines the assets of the nomothetic and idiographic approaches by creating person-specific maps that contain a group-level structure. The maps show how intensively measured variables predict and are predicted by each other at different time scales. In this article, GIMME is introduced conceptually and mathematically, and then applied to an empirical data set containing the negative affect, detachment, disinhibition, and hostility composite ratings from the daily diaries of 25 individuals with personality pathology. Results are discussed with the aim of elucidating GIMME's potential for clinical research and practice.

Extracting business vocabularies from business process models: SBVR and BPMN standards-based approach

Science.gov (United States)

Skersys, Tomas; Butleris, Rimantas; Kapocius, Kestutis

2013-10-01

Approaches for the analysis and specification of business vocabularies and rules are very relevant topics in both Business Process Management and Information Systems Development disciplines. However, in common practice of Information Systems Development, the Business modeling activities still are of mostly empiric nature. In this paper, basic aspects of the approach for business vocabularies' semi-automated extraction from business process models are presented. The approach is based on novel business modeling-level OMG standards "Business Process Model and Notation" (BPMN) and "Semantics for Business Vocabularies and Business Rules" (SBVR), thus contributing to OMG's vision about Model-Driven Architecture (MDA) and to model-driven development in general.

Liver involvement in Gaucher disease - Review and clinical approach.

Science.gov (United States)

Adar, Tomer; Ilan, Yaron; Elstein, Deborah; Zimran, Ari

2018-02-01

Gaucher disease (GD), one of the most prevalent lysosomal storage diseases, is associated with glucocerebroside accumulation in cells of the monocyte-macrophage system in various organs, including the liver. Evaluating and managing liver disease in patients with Gaucher disease may be challenging. While hepatic involvement is common in Gaucher disease, its severity, and clinical significance span a wide spectrum, ranging from sub-clinical involvement to liver cirrhosis with its associated complications including portal hypertension. Apart from liver involvement in Gaucher disease, patients with may also suffer from other comorbidities involving the liver. That Gaucher disease itself can mimic hepatic lesions, affect laboratory tests used to characterize liver disease, and may be associated with non-cirrhotic portal hypertension, complicates the diagnostic approach even more. Better understanding of liver involvement in Gaucher disease can spare patients unnecessary invasive testing, and assist physicians in decision making when evaluating patients with Gaucher disease suspected for significant liver disease. This review describes the various clinical manifestations, laboratory and imaging abnormalities that may be encountered when following patients with Gaucher disease for liver involvement. The mechanism for liver disease are discussed, as well as the possible hepato-protective effect of glucocerebroside, and the a diagnostic and treatment approaches. Copyright © 2016 Elsevier Inc. All rights reserved.

A neurophysiological approach to tinnitus: clinical implications.

Science.gov (United States)

Jastreboff, P J; Hazell, J W

1993-02-01

This paper presents a neurophysiological approach to tinnitus and discusses its clinical implications. A hypothesis of discordant damage of inner and outer hair cells systems in tinnitus generation is outlined. A recent animal model has facilitated the investigation of the mechanisms of tinnitus and has been further refined to allow for the measurement of tinnitus pitch and loudness. The analysis of the processes involved in tinnitus detection postulates the involvement of an abnormal increase of gain within the auditory system. Moreover, it provides a basis for treating patients with hyperacusis, which we are considering to be a pre-tinnitus state. Analysis of the process of tinnitus perception allows for the possibility of facilitating the process of tinnitus habituation for the purpose of its alleviation. The combining of theoretical analysis with clinical findings has resulted in the creation of a multidisciplinary Tinnitus Centre. The foundation of the Centre focuses on two goals: the clinical goal is to remove tinnitus perception from the patient's consciousness, while directing research toward finding a mechanism-based method for the suppression of tinnitus generators and processes responsible for enhancement of tinnitus-related neuronal activity.

Systemic Sclerosis and the Gastrointestinal Tract-Clinical Approach.

Science.gov (United States)

Braun-Moscovici, Yolanda; Brun, Rita; Braun, Marius

2016-10-31

Systemic sclerosis (SSc) is a multisystem disease characterized by functional and structural abnormalities of small blood vessels, fibrosis of the skin and internal organs, immune system activation, and autoimmunity. The gastrointestinal tract is involved in nearly all patients and is a source of significant morbidity and even mortality. The aim of this review is to summarize the pathogenesis and to provide a clinical approach to these patients.

[ISO 9001certification of a quality management system in a clinical investigation center].

Science.gov (United States)

Chesnais, Jimmy; Fougerou-Leurent, Claire; Laforest, Claire; Renault, Alain; Bellissant, Eric; Laviolle, Bruno

2018-05-03

Beyond the application of legal requirements, clinical trials must have a permanent approach of quality control. The clinical investigation centers (CICs) are academic structures of clinical research certified by the French National institute of health and medical research (Inserm) and whose functioning relies on recommendations of good practice. It is important to accompany this standardization of practices by the implementation of a quality management system. This article presents the process that enabled the CIC of Rennes to become certified ISO 9001 by French standards association (Afnor) certification in May, 2016. The application of the fundamental principles of the standard ISO 9001 in the domain of clinical research is approached. The problem of the perimeter for the certification and the related process mapping are exposed. The activities of methodology, management and analysis of clinical studies were chosen for the initial certification of the CIC of Rennes. The perspectives for the extension of the perimeter of certification are also approached at the end of article. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

European AIDS Clinical Society Second Standard of Care Meeting, Brussels 16-17 November 2016

DEFF Research Database (Denmark)

De Wit, S; Battegay, M; D'Arminio Monforte, A

2018-01-01

The European AIDS Clinical Society (EACS) organized a second meeting on Standard of Care in Europe on November 16-17 th, 2016. The aims of the meeting were to discuss and propose actions on three topics, namely: Adherence to guidelines for treatment initiation, treatment monitoring and outcomes, ...

In-silico approach to the development of a prototype clinical ...

African Journals Online (AJOL)

International Journal of Natural and Applied Sciences ... In-silico approaches to information management of pediatrics sections of hospitals could ... This study was aimed at developing a prototype clinic information system for keeping track of ...

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

THE APPROACH OF CANCER RELATED FATIGUE IN RHEABILITATION MEDICINE: PART I – MECHANISMS, SYMPTOMS, CLINICAL EVALUATION AND SCREENING

Directory of Open Access Journals (Sweden)

SALCA Amalia

2015-05-01

Full Text Available Cancer related fatigue (CRF is the most disabling and distressing symptom in cancer, throughout the whole history of the illness, including successfully treated cases. Rehabilitation medicine could have a positive impact on these patients’ outcomes, if well targeted. With these purpose, the rehabilitation clinician needs to correctly assess fatigue using standard, reliable scales. This review of articles and trials synthesizes the epidemiology, mechanics (including causes and effects, clinical presentation and means of assessment in CRF. CRF causes and mechanisms are not well known. Understanding them would provide specific targets to fatigue management. Clinical presentation is very variable, a wide range of features being found in literature. Poorly medical reports in assessing fatigue offer variable percentages of prevalence, inconsistent with patients’ daily burden due to CRF. There are many tools used to assess fatigue in clinical research and on them depends the percentages reported as fatigue prevalence. The hereby gathered information are useful in the approach of a patient that addresses to a rehabilitation clinician for CRF management.

76 FR 28990 - Ultra High Throughput Sequencing for Clinical Diagnostic Applications-Approaches To Assess...

Science.gov (United States)

2011-05-19

... Web cast of the public meeting, you must register online at http://www.fda.gov/MedicalDevices/News... technologies are currently extensively used in research and are entering clinical diagnostic use; they are... technologies for clinical applications, appropriate evaluation tools (e.g., standards, well established...

Postimplant Dosimetry Using a Monte Carlo Dose Calculation Engine: A New Clinical Standard

International Nuclear Information System (INIS)

Carrier, Jean-Francois; D'Amours, Michel; Verhaegen, Frank; Reniers, Brigitte; Martin, Andre-Guy; Vigneault, Eric; Beaulieu, Luc

2007-01-01

Purpose: To use the Monte Carlo (MC) method as a dose calculation engine for postimplant dosimetry. To compare the results with clinically approved data for a sample of 28 patients. Two effects not taken into account by the clinical calculation, interseed attenuation and tissue composition, are being specifically investigated. Methods and Materials: An automated MC program was developed. The dose distributions were calculated for the target volume and organs at risk (OAR) for 28 patients. Additional MC techniques were developed to focus specifically on the interseed attenuation and tissue effects. Results: For the clinical target volume (CTV) D 90 parameter, the mean difference between the clinical technique and the complete MC method is 10.7 Gy, with cases reaching up to 17 Gy. For all cases, the clinical technique overestimates the deposited dose in the CTV. This overestimation is mainly from a combination of two effects: the interseed attenuation (average, 6.8 Gy) and tissue composition (average, 4.1 Gy). The deposited dose in the OARs is also overestimated in the clinical calculation. Conclusions: The clinical technique systematically overestimates the deposited dose in the prostate and in the OARs. To reduce this systematic inaccuracy, the MC method should be considered in establishing a new standard for clinical postimplant dosimetry and dose-outcome studies in a near future

Quality standards for DNA sequence variation databases to improve clinical management under development in Australia

Directory of Open Access Journals (Sweden)

B. Bennetts

2014-09-01

Full Text Available Despite the routine nature of comparing sequence variations identified during clinical testing to database records, few databases meet quality requirements for clinical diagnostics. To address this issue, The Royal College of Pathologists of Australasia (RCPA in collaboration with the Human Genetics Society of Australasia (HGSA, and the Human Variome Project (HVP is developing standards for DNA sequence variation databases intended for use in the Australian clinical environment. The outputs of this project will be promoted to other health systems and accreditation bodies by the Human Variome Project to support the development of similar frameworks in other jurisdictions.

Clinical decision making-a functional medicine perspective.

Science.gov (United States)

Pizzorno, Joseph E

2012-09-01

As 21st century health care moves from a disease-based approach to a more patient-centric system that can address biochemical individuality to improve health and function, clinical decision making becomes more complex. Accentuating the problem is the lack of a clear standard for this more complex functional medicine approach. While there is relatively broad agreement in Western medicine for what constitutes competent assessment of disease and identification of related treatment approaches, the complex functional medicine model posits multiple and individualized diagnostic and therapeutic approaches, most or many of which have reasonable underlying science and principles, but which have not been rigorously tested in a research or clinical setting. This has led to non-rigorous thinking and sometimes to uncritical acceptance of both poorly documented diagnostic procedures and ineffective therapies, resulting in less than optimal clinical care.

Parallelism measurement for base plate of standard artifact with multiple tactile approaches

Science.gov (United States)

Ye, Xiuling; Zhao, Yan; Wang, Yiwen; Wang, Zhong; Fu, Luhua; Liu, Changjie

2018-01-01

Nowadays, as workpieces become more precise and more specialized which results in more sophisticated structures and higher accuracy for the artifacts, higher requirements have been put forward for measuring accuracy and measuring methods. As an important method to obtain the size of workpieces, coordinate measuring machine (CMM) has been widely used in many industries. In order to achieve the calibration of a self-developed CMM, it is found that the parallelism of the base plate used for fixing the standard artifact is an important factor which affects the measurement accuracy in the process of studying self-made high-precision standard artifact. And aimed to measure the parallelism of the base plate, by using the existing high-precision CMM, gauge blocks, dial gauge and marble platform with the tactile approach, three methods for parallelism measurement of workpieces are employed, and comparisons are made within the measurement results. The results of experiments show that the final accuracy of all the three methods is able to reach micron level and meets the measurement requirements. Simultaneously, these three approaches are suitable for different measurement conditions which provide a basis for rapid and high-precision measurement under different equipment conditions.

Improving the road wear performance of heavy vehicles in South Africa using a performance-based standards approach

CSIR Research Space (South Africa)

Nordengen, Paul A

2010-05-01

Full Text Available of the world to achieve regional harmonisation and effective road use have had limited success. Another approach is to consider performance-based standards (PBS); in this case standards specify the performance required from the operation of a vehicle on a...

A predictive approach to selecting the size of a clinical trial, based on subjective clinical opinion.

Science.gov (United States)

Spiegelhalter, D J; Freedman, L S

1986-01-01

The 'textbook' approach to determining sample size in a clinical trial has some fundamental weaknesses which we discuss. We describe a new predictive method which takes account of prior clinical opinion about the treatment difference. The method adopts the point of clinical equivalence (determined by interviewing the clinical participants) as the null hypothesis. Decision rules at the end of the study are based on whether the interval estimate of the treatment difference (classical or Bayesian) includes the null hypothesis. The prior distribution is used to predict the probabilities of making the decisions to use one or other treatment or to reserve final judgement. It is recommended that sample size be chosen to control the predicted probability of the last of these decisions. An example is given from a multi-centre trial of superficial bladder cancer.

Statistical approaches for evaluating body composition markers in clinical cancer research.

Science.gov (United States)

Bayar, Mohamed Amine; Antoun, Sami; Lanoy, Emilie

2017-04-01

The term 'morphomics' stands for the markers of body composition in muscle and adipose tissues. in recent years, as part of clinical cancer research, several associations between morphomics and outcome or toxicity were found in different treatment settings leading to a growing interest. we aim to review statistical approaches used to evaluate these markers and suggest practical statistical recommendations. Area covered: We identified statistical methods used recently to take into account properties of morphomics measurements. We also reviewed adjustment methods on major confounding factors such as gender and approaches to model morphomic data, especially mixed models for repeated measures. Finally, we focused on methods for determining a cut-off for a morphomic marker that could be used in clinical practice and how to assess its robustness. Expert commentary: From our review, we proposed 13 key points to strengthen analyses and reporting of clinical research assessing associations between morphomics and outcome or toxicity.

A Generalizability Theory Approach to Standard Error Estimates for Bookmark Standard Settings

Science.gov (United States)

Lee, Guemin; Lewis, Daniel M.

2008-01-01

The bookmark standard-setting procedure is an item response theory-based method that is widely implemented in state testing programs. This study estimates standard errors for cut scores resulting from bookmark standard settings under a generalizability theory model and investigates the effects of different universes of generalization and error…

An outcome-based approach for the creation of fetal growth standards: do singletons and twins need separate standards?

Science.gov (United States)

Joseph, K S; Fahey, John; Platt, Robert W; Liston, Robert M; Lee, Shoo K; Sauve, Reg; Liu, Shiliang; Allen, Alexander C; Kramer, Michael S

2009-03-01

Contemporary fetal growth standards are created by using theoretical properties (percentiles) of birth weight (for gestational age) distributions. The authors used a clinically relevant, outcome-based methodology to determine if separate fetal growth standards are required for singletons and twins. All singleton and twin livebirths between 36 and 42 weeks' gestation in the United States (1995-2002) were included, after exclusions for missing information and other factors (n = 17,811,922). A birth weight range was identified, at each gestational age, over which serious neonatal morbidity and neonatal mortality rates were lowest. Among singleton males at 40 weeks, serious neonatal morbidity/mortality rates were lowest between 3,012 g (95% confidence interval (CI): 3,008, 3,018) and 3,978 g (95% CI: 3,976, 3,980). The low end of this optimal birth weight range for females was 37 g (95% CI: 21, 53) less. The low optimal birth weight was 152 g (95% CI: 121, 183) less for twins compared with singletons. No differences were observed in low optimal birth weight by period (1999-2002 vs. 1995-1998), but small differences were observed for maternal education, race, parity, age, and smoking status. Patterns of birth weight-specific serious neonatal morbidity/neonatal mortality support the need for plurality-specific fetal growth standards.

Mid-level healthcare personnel training: an evaluation of the revised, nationally-standardized, pre-service curriculum for clinical officers in Mozambique.

Science.gov (United States)

Feldacker, Caryl; Chicumbe, Sergio; Dgedge, Martinho; Augusto, Gerito; Cesar, Freide; Robertson, Molly; Mbofana, Francisco; O'Malley, Gabrielle

2014-01-01

Mozambique suffers from a critical shortage of healthcare workers. Mid-level healthcare workers, (Tecnicos de Medicina Geral (TMG)), in Mozambique require less money and time to train than physicians. From 2009-2010, the Mozambique Ministry of Health (MoH) and the International Training and Education Center for Health (I-TECH), University of Washington, Seattle, revised the TMG curriculum. To evaluate the effect of the curriculum revision, we used mixed methods to determine: 1) if TMGs meet the MoH's basic standards of clinical competency; and 2) do scores on measurements of clinical knowledge, physical exam, and clinical case scenarios differ by curriculum? T-tests of differences in means examined differences in continuous score variables between curriculum groups. Univariate and multivariate linear regression models assess curriculum-related and demographic factors associated with assessment scores on each of the three evaluation methods at the pTMG scores on both the clinical cases and physical exam. TMGs trained in either curriculum may be inadequately prepared to provide quality care. Curriculum changes are a necessary, but insufficient, part of improving TMG knowledge and skills overall. A more comprehensive, multi-level approach to improving TMG training that includes post-graduation mentoring, strengthening the pre-service internship training, and greater resources for training institute faculty may result in improvements in TMG capacity and patient care over time.

Approaches for protection standards for ionizing radiation and combustion pollutants

International Nuclear Information System (INIS)

Butler, G.C.

1978-01-01

The question ''can the approach used for radiation protection standards, i.e., to extrapolate dose--response relationships to low doses, be applied to combustion pollutants'' provided a basis for discussion. The linear, nonthreshold model postulated by ICRP and UNSCEAR for late effects of ionizing radiation is described and discussed. The utility and problems of applying this model to the effects of air pollutants constitute the focus of this paper. The conclusion is that, in the absence of evidence to the contrary, one should assume the same type of dose--effect relation for chemical air pollutants as for ionizing radiation

Standards for Standardized Logistic Regression Coefficients

Science.gov (United States)

Menard, Scott

2011-01-01

Standardized coefficients in logistic regression analysis have the same utility as standardized coefficients in linear regression analysis. Although there has been no consensus on the best way to construct standardized logistic regression coefficients, there is now sufficient evidence to suggest a single best approach to the construction of a…

ORAL CLINICAL LONG CASE PRESENTATION, THE NEED FOR STANDARDIZATION AND DOCUMENTATION.

Science.gov (United States)

Agodirin, S O; Olatoke, S A; Rahman, G A; Agbakwuru, E A; Kolawole, O A

2015-01-01

The oral presentation of the clinical long case is commonly an implied knowledge. The challenge of the presentation is compounded by the examiners' preferences and sometimes inadequate understanding of what should be assessed. To highlight the different opinions and misconceptions of trainers as the basis for improving our understanding and assessment of oral presentation of the clinical long case. Questionnaire was administered during the West African College of Surgeons fellowship clinical examinations and at their workplaces. Eligibility criteria included being a surgeon, a trainer and responding to all questions. Of the 72 questionnaires that were returned, 36(50%) were eligible for the analysis. The 36 respondents were from 14 centers in Nigeria and Ghana. Fifty-two percent were examiners at the postgraduate medical colleges and 9(25%) were professors. Eight(22.2%) indicated they were unaware of the separate methods of oral presentation for different occasions while 21( 58.3%) respondents were aware that candidate used the "5Cs" method and the traditional compartmentalized method in long case oral presentation. Eleven(30.6%) wanted postgraduates to present differently on a much higher level than undergraduate despite not encountering same in literature and 21(58.3%) indicated it was an unwritten rule. Seventeen (47.2%) had not previously encountered the "5Cs" of history of presenting complaint in literature also 17(47.2%) teach it to medical students and their junior residents. This study has shown that examiners definitely have varying opinions on what form the oral presentation of the clinical long case at surgery fellowship/professional examination should be and it translates to their expectations of the residents or clinical students. This highlights the need for standardization and consensus of what is expected at a formal oral presentation during the clinical long case examination in order to avoid subjectivity and bias.

Cardiopulmonary resuscitation standards for clinical practice and training in the UK.

Science.gov (United States)

Gabbott, David; Smith, Gary; Mitchell, Sarah; Colquhoun, Michael; Nolan, Jerry; Soar, Jasmeet; Pitcher, David; Perkins, Gavin; Phillips, Barbara; King, Ben; Spearpoint, Ken

2005-07-01

The Royal College of Anaesthetists, the Royal College of Physicians, the Intensive Care Society and the Resuscitation Council (UK) have published new resuscitation standards. The document provides advice to UK healthcare organisations, resuscitation committees and resuscitation officers on all aspects of the resuscitation service. It includes sections on resuscitation training, resuscitation equipment, the cardiac arrest team, cardiac arrest prevention, patient transfer, post-resuscitation care, audit and research. The document makes several recommendations. Healthcare institutions should have, or be represented on, a resuscitation committee that is responsible for all resuscitation issues. Every institution should have at least one resuscitation officer responsible for teaching and conducting training in resuscitation techniques. Staff with patient contact should be given regular resuscitation training appropriate to their expected abilities and roles. Clinical staff should receive regular training in the recognition of patients at risk of cardiopulmonary arrest and the measures required for the prevention of cardiopulmonary arrest. Healthcare institutions admitting acutely ill patients should have a resuscitation team, or its equivalent, available at all times. Clear guidelines should be available indicating how and when to call for the resuscitation team. Cardiopulmonary arrest should be managed according to current national guidelines. Resuscitation equipment should be available throughout the institution for clinical use and for training. The practice of resuscitation should be audited to maintain and improve standards of care. A do not attempt resuscitation (DNAR) policy should be compiled, communicated to relevant members of staff, used and audited regularly. Funding must be provided to support an effective resuscitation service.

Standardized 15N tracer method for the determination of parameters of the whole-body protein metabolism in clinical practice

International Nuclear Information System (INIS)

Junghans, P.; Jung, K.; Matkowitz, R.

1984-01-01

A standardized 15 N tracer method is described for the assessment of nitrogen and protein metabolism in healthy and pathological changed organisms. The method represents an isotope technical procedure for the application in clinical research and practice. The clinical preparation of the patient/proband by means of a standardized nutritional regime, the tracer administration (single dose) and the sampling (urine, blood), the 15 N tracer technique (sample chemistry, emissionsspectrometric isotope analysis) and the mathematical evaluation of 15 N tracer data are described. (author)

[The analytical reliability of clinical laboratory information and role of the standards in its support].

Science.gov (United States)

Men'shikov, V V

2012-12-01

The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

Neurological gait disorders in elderly people: clinical approach and classification.

NARCIS (Netherlands)

Snijders, A.H.; Warrenburg, B.P.C. van de; Giladi, N.; Bloem, B.R.

2007-01-01

Gait disorders are common and often devastating companions of ageing, leading to reductions in quality of life and increased mortality. Here, we present a clinically oriented approach to neurological gait disorders in the elderly population. We also draw attention to several exciting scientific

Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation.

Science.gov (United States)

van Es, Suzanne C; Venema, Clasina M; Glaudemans, Andor W J M; Lub-de Hooge, Marjolijn N; Elias, Sjoerd G; Boellaard, Ronald; Hospers, Geke A P; Schröder, Carolina P; de Vries, Elisabeth G E

2016-02-01

Molecular imaging with PET is a rapidly emerging technique. In breast cancer patients, more than 45 different PET tracers have been or are presently being tested. With a good rationale, after development of the tracer and proven feasibility, it is of interest to evaluate whether there is a potential meaningful role for the tracer in the clinical setting-such as in staging, in the (early) prediction of a treatment response, or in supporting drug choices. So far, only (18)F-FDG PET has been incorporated into breast cancer guidelines. For proof of the clinical relevance of tracers, especially for analysis in a multicenter setting, standardization of the technology and access to the novel PET tracer are required. However, resources for PET implementation research are limited. Therefore, next to randomized studies, novel approaches are required for proving the clinical value of PET tracers with the smallest possible number of patients. The aim of this review is to describe the process of the development of PET tracers and the level of evidence needed for the use of these tracers in breast cancer. Several breast cancer trials have been performed with the PET tracers (18)F-FDG, 3'-deoxy-3'-(18)F-fluorothymidine ((18)F-FLT), and (18)F-fluoroestradiol ((18)F-FES). We studied them to learn lessons for the implementation of novel tracers. After defining the gap between a good rationale for a tracer and implementation in the clinical setting, we propose solutions to fill the gap to try to bring more PET tracers to daily clinical practice. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

OntoCR: A CEN/ISO-13606 clinical repository based on ontologies.

Science.gov (United States)

Lozano-Rubí, Raimundo; Muñoz Carrero, Adolfo; Serrano Balazote, Pablo; Pastor, Xavier

2016-04-01

To design a new semantically interoperable clinical repository, based on ontologies, conforming to CEN/ISO 13606 standard. The approach followed is to extend OntoCRF, a framework for the development of clinical repositories based on ontologies. The meta-model of OntoCRF has been extended by incorporating an OWL model integrating CEN/ISO 13606, ISO 21090 and SNOMED CT structure. This approach has demonstrated a complete evaluation cycle involving the creation of the meta-model in OWL format, the creation of a simple test application, and the communication of standardized extracts to another organization. Using a CEN/ISO 13606 based system, an indefinite number of archetypes can be merged (and reused) to build new applications. Our approach, based on the use of ontologies, maintains data storage independent of content specification. With this approach, relational technology can be used for storage, maintaining extensibility capabilities. The present work demonstrates that it is possible to build a native CEN/ISO 13606 repository for the storage of clinical data. We have demonstrated semantic interoperability of clinical information using CEN/ISO 13606 extracts. Copyright © 2016 Elsevier Inc. All rights reserved.

Standardization and classification of In vitro biofilm formation by clinical isolates of Staphylococcus aureus

Directory of Open Access Journals (Sweden)

Ashish Kumar Singh

2017-01-01

Full Text Available Background: Staphylococcus aureus is Gram-positive bacterium commonly associated with nosocomial infections. The development of biofilm exhibiting drug resistance especially in foreign body associated infections has enabled the bacterium to draw considerable attention. However, till date, consensus guidelines for in vitro biofilm quantitation and categorization criterion for the bacterial isolates based on biofilm-forming capacity are lacking. Therefore, it was intended to standardize in vitro biofilm formation by clinical isolates of S. aureus and then to classify them on the basis of their biofilm-forming capacity. Materials and Methods: A study was conducted for biofilm quantitation by tissue culture plate (TCP assay employing 61 strains of S. aureus isolated from clinical samples during May 2015– December 2015 wherein several factors influencing the biofilm formation were optimized. Therefore, it was intended to propose a biofilm classification criteria based on the standard deviation multiples of the control differentiating them into non, low, medium, and high biofilm formers. Results: Brain-heart infusion broth was found to be more effective in biofilm formation compared to trypticase soy broth. Heat fixation was more effective than chemical fixation. Although, individually, glucose, sucrose, and sodium chloride (NaCl had no significant effect on biofilm formation, a statistically significant increase in absorbance was observed after using the supplement mix consisting of 222.2 mM glucose, 116.9 mM sucrose, and 1000 mM NaCl (P = 0.037. Conclusions: The present study puts forth a standardized in vitro TCP assay for biofilm biomass quantitation and categorization criteria for clinical isolates of S. aureus based on their biofilm-forming capacity. The proposed in vitro technique may be further evaluated for its usefulness in the management of persistent infections caused by the bacterium.

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...

Activating clinical trials: a process improvement approach.

Science.gov (United States)

Martinez, Diego A; Tsalatsanis, Athanasios; Yalcin, Ali; Zayas-Castro, José L; Djulbegovic, Benjamin

2016-02-24

The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making. We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July 2011 and June 2012. We described the process using value stream mapping, studied the interactions of the various process participants using social network analysis, and modeled potential process modifications using discrete-event simulation. The administrative process comprised 5 sub-processes, 30 activities, 11 decision points, 5 loops, and 8 participants. The mean activation time was 76.6 days. Rate-limiting sub-processes were those of contract and budget development. Key participants during contract and budget development were the Office of Clinical Research, sponsors, and the principal investigator. Simulation results indicate that slight increments on the number of trials, arriving to the Office of Clinical Research, would increase activation time by 11 %. Also, incrementing the efficiency of contract and budget development would reduce the activation time by 28 %. Finally, better synchronization between contract and budget development would reduce time spent on batching documentation; however, no improvements would be attained in total activation time. The presented process improvement analytic framework not only identifies administrative barriers, but also helps to devise and evaluate potential improvement scenarios. The strength

Short Shrift to Long Lists: An Alternative Approach to the Development of Performance Standards for School Principals.

Science.gov (United States)

Louden, William; Wildy, Helen

1999-01-01

Describes examples of standards frameworks for principals' work operant in three countries and describes an alternative approach based on interviewing 40 Australian principals. By combining qualitative case studies with probabilistic measurement techniques, the alternative approach provides contextually rich descriptions of growth in performance…

Incorporating Standardized Colleague Simulations in a Clinical Assessment Course and Evaluating the Impact on Interprofessional Communication.

Science.gov (United States)

Shrader, Sarah; Dunn, Brianne; Blake, Elizabeth; Phillips, Cynthia

2015-05-25

To determine the impact of incorporating standardized colleague simulations on pharmacy students' confidence and interprofessional communication skills. Four simulations using standardized colleagues portraying attending physicians in inpatient and outpatient settings were integrated into a required course. Pharmacy students interacted with the standardized colleagues using the Situation, Background, Assessment, Request/Recommendation (SBAR) communication technique and were evaluated on providing recommendations while on simulated inpatient rounds and in an outpatient clinic. Additionally, changes in student attitudes and confidence toward interprofessional communication were assessed with a survey before and after the standardized colleague simulations. One hundred seventy-one pharmacy students participated in the simulations. Student interprofessional communication skills improved after each simulation. Student confidence with interprofessional communication in both inpatient and outpatient settings significantly improved. Incorporation of simulations using standardized colleagues improves interprofessional communication skills and self-confidence of pharmacy students.

Oral Pathology in Clinical Dentistry: A systematic approach

Directory of Open Access Journals (Sweden)

R V Subramanyam

2014-01-01

Full Text Available The dental clinician frequently comes across lesions that involve the hard and soft tissues of the oral cavity. Most of these conditions do not pose a diagnostic problem for the dental surgeon. However, the clinical dentist is sometimes accosted with a lesion, the diagnosis of which is not only challenging, but influencing the choice of treatment. This review article provides a systematic and logical approach for diagnosing common lesions encountered in the dental practice.

Analyzing Statistical Mediation with Multiple Informants: A New Approach with an Application in Clinical Psychology

Directory of Open Access Journals (Sweden)

Lesther ePapa

2015-11-01

Full Text Available Testing mediation models is critical for identifying potential variables that need to be targeted to effectively change one or more outcome variables. In addition, it is now common practice for clinicians to use multiple informant (MI data in studies of statistical mediation. By coupling the use of MI data with statistical mediation analysis, clinical researchers can combine the benefits of both techniques. Integrating the information from MIs into a statistical mediation model creates various methodological and practical challenges. The authors review prior methodological approaches to MI mediation analysis in clinical research and propose a new latent variable approach that overcomes some limitations of prior approaches. An application of the new approach to mother, father, and child reports of impulsivity, frustration tolerance, and externalizing problems (N = 454 is presented. The results showed that frustration tolerance mediated the relationship between impulsivity and externalizing problems. Advantages and limitations of the new approach are discussed. The new approach can help clinical researchers overcome limitations of prior techniques. It allows for a more comprehensive and effective use of MI data when testing mediation models.

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.

Towards the standardization of stem cell therapy studies for ischemic heart diseases: Bridging the gap between animal models and the clinical setting.

Science.gov (United States)

Trindade, Fábio; Leite-Moreira, Adelino; Ferreira-Martins, João; Ferreira, Rita; Falcão-Pires, Inês; Vitorino, Rui

2017-02-01

Today there is an increasing demand for heart transplantations for patients diagnosed with heart failure. Though, shortage of donors as well as the large number of ineligible patients hurdle such treatment option. This, in addition to the considerable number of transplant rejections, has driven the clinical research towards the field of regenerative medicine. Nonetheless, to date, several stem cell therapies tested in animal models fall by the wayside and when they meet the criteria to clinical trials, subjects often exhibit modest improvements. A main issue slowing down the admission of such therapies in the domain of human trials is the lack of protocol standardization between research groups, which hampers comparison between different approaches as well as the lack of thought regarding the clinical translation. In this sense, given the large amount of reports on stem cell therapy studies in animal models reported in the last 3years, we sought to evaluate their advantages and limitations towards the clinical setting and provide some suggestions for the forthcoming investigations. We expect, with this review, to start a new paradigm on regenerative medicine, by evoking the debate on how to plan novel stem cell therapy studies with animal models in order to achieve more consistent scientific production and accelerate the admission of stem cell therapies in the clinical setting. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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).

Standard plants, standard outages: the EdF approach

International Nuclear Information System (INIS)

Miron, J.L.

1991-01-01

At the end of 1990 Electricite de France had carried out a total of 350 PWR refuelling outages. Although the French units are standardized the routine of the outages are not all the same. The major influences on outages were: setting up new organizations to apply quality assurance regulations; improving systematic experience feedback; incorporating modifications in the outage schedules; assumilation of computerized maintenance management by the sites. (author)

Antibacterial activity of amino- and amido- terminated poly (amidoamine)-G6 dendrimer on isolated bacteria from clinical specimens and standard strains

Science.gov (United States)

Rastegar, Ayoob; Nazari, Shahram; Allahabadi, Ahmad; Falanji, Farahnaz; Akbari Dourbash, Fakhreddin Akbari Dourbash; Rezai, Zahra; Alizadeh Matboo, Soudabeh; Hekmat-Shoar, Reza; Mohseni, Seyed Mohsen; Majidi, Gharib

2017-01-01

Background: Nanoscale poly (amidoamine) dendrimers have been investigated for their biological demands, but their antibacterial activity has not been widely discovered. Thus, the sixth generation of poly (amidoamine) dendrimer (PAMAM-G6) was synthesized and its antibacterial activities were evaluated on Gram-negative bacteria; P. aeruginosa, E. coli, A. baumannii, S. typhimurium, S. dysenteriae, K. pneumoniae, P. mirabilis, and Gram-positive bacteria, and S.aureus and B. subtilis, which were isolated from different clinical specimens and standard strains of these bacteria. Methods: In this study, 980 specimens including urine (47%), blood (27%), sputum (13%), wounds (8%), and burns (5%) were collected from clinical specimens of 16 hospitals and clinics in city of Sabzevar, Iran. Then, the target bacteria were isolated and identified using standard methods. Minimum inhibitory concentration and minimum bactericidal concentrations against Gram-positive and Gram-negative bacteria were determined according to guidelines described by clinical and laboratory standards institute (CLSI). Standard discs were prepared using 0.025, 0.25, 2.5, and 25 μg/mL concentrations of PAMAM-G6 on Mueller-Hinton agar plates to determinate the zone of inhibition. The cytotoxicity of PAMAM-G6 dendrimer was evaluated in HCT116 cells by MTT assay. Results: The most important isolated bacteria were E. coli (23.65%), S. aureus (24.7%), P. aeruginosa (10.49%), B. subtilis (7.7%), S. typhimurium (8.87%), A. baumannii (7.02%), K. pneumoniae (7.1%), P. mirabilis (6.46%), and S. dysenteriae (3.6%). Moreover, it was found that poly (amidoamine)–G6 exhibited more antibacterial efficacy on standard strains than isolated bacteria from clinical samples (p<0.05). The cytotoxicity of PAMAM-G6 to the cells showed that cytotoxicity depended on the concentration level and exposure time. Conclusion: The PAMAM-G6 dendrimer showed a positive impact on the removal of dominant bacterial isolated from clinical

Personalized translational epilepsy research - Novel approaches and future perspectives: Part I: Clinical and network analysis approaches.

Science.gov (United States)

Rosenow, Felix; van Alphen, Natascha; Becker, Albert; Chiocchetti, Andreas; Deichmann, Ralf; Deller, Thomas; Freiman, Thomas; Freitag, Christine M; Gehrig, Johannes; Hermsen, Anke M; Jedlicka, Peter; Kell, Christian; Klein, Karl Martin; Knake, Susanne; Kullmann, Dimitri M; Liebner, Stefan; Norwood, Braxton A; Omigie, Diana; Plate, Karlheinz; Reif, Andreas; Reif, Philipp S; Reiss, Yvonne; Roeper, Jochen; Ronellenfitsch, Michael W; Schorge, Stephanie; Schratt, Gerhard; Schwarzacher, Stephan W; Steinbach, Joachim P; Strzelczyk, Adam; Triesch, Jochen; Wagner, Marlies; Walker, Matthew C; von Wegner, Frederic; Bauer, Sebastian

2017-11-01

Despite the availability of more than 15 new "antiepileptic drugs", the proportion of patients with pharmacoresistant epilepsy has remained constant at about 20-30%. Furthermore, no disease-modifying treatments shown to prevent the development of epilepsy following an initial precipitating brain injury or to reverse established epilepsy have been identified to date. This is likely in part due to the polyetiologic nature of epilepsy, which in turn requires personalized medicine approaches. Recent advances in imaging, pathology, genetics and epigenetics have led to new pathophysiological concepts and the identification of monogenic causes of epilepsy. In the context of these advances, the First International Symposium on Personalized Translational Epilepsy Research (1st ISymPTER) was held in Frankfurt on September 8, 2016, to discuss novel approaches and future perspectives for personalized translational research. These included new developments and ideas in a range of experimental and clinical areas such as deep phenotyping, quantitative brain imaging, EEG/MEG-based analysis of network dysfunction, tissue-based translational studies, innate immunity mechanisms, microRNA as treatment targets, functional characterization of genetic variants in human cell models and rodent organotypic slice cultures, personalized treatment approaches for monogenic epilepsies, blood-brain barrier dysfunction, therapeutic focal tissue modification, computational modeling for target and biomarker identification, and cost analysis in (monogenic) disease and its treatment. This report on the meeting proceedings is aimed at stimulating much needed investments of time and resources in personalized translational epilepsy research. Part I includes the clinical phenotyping and diagnostic methods, EEG network-analysis, biomarkers, and personalized treatment approaches. In Part II, experimental and translational approaches will be discussed (Bauer et al., 2017) [1]. Copyright © 2017 Elsevier Inc

MASTER: a model to improve and standardize clinical breakpoints for antimicrobial susceptibility testing using forecast probabilities.

Science.gov (United States)

Blöchliger, Nicolas; Keller, Peter M; Böttger, Erik C; Hombach, Michael

2017-09-01

The procedure for setting clinical breakpoints (CBPs) for antimicrobial susceptibility has been poorly standardized with respect to population data, pharmacokinetic parameters and clinical outcome. Tools to standardize CBP setting could result in improved antibiogram forecast probabilities. We propose a model to estimate probabilities for methodological categorization errors and defined zones of methodological uncertainty (ZMUs), i.e. ranges of zone diameters that cannot reliably be classified. The impact of ZMUs on methodological error rates was used for CBP optimization. The model distinguishes theoretical true inhibition zone diameters from observed diameters, which suffer from methodological variation. True diameter distributions are described with a normal mixture model. The model was fitted to observed inhibition zone diameters of clinical Escherichia coli strains. Repeated measurements for a quality control strain were used to quantify methodological variation. For 9 of 13 antibiotics analysed, our model predicted error rates of  0.1% for ampicillin, cefoxitin, cefuroxime and amoxicillin/clavulanic acid. Increasing the susceptible CBP (cefoxitin) and introducing ZMUs (ampicillin, cefuroxime, amoxicillin/clavulanic acid) decreased error rates to < 0.1%. ZMUs contained low numbers of isolates for ampicillin and cefuroxime (3% and 6%), whereas the ZMU for amoxicillin/clavulanic acid contained 41% of all isolates and was considered not practical. We demonstrate that CBPs can be improved and standardized by minimizing methodological categorization error rates. ZMUs may be introduced if an intermediate zone is not appropriate for pharmacokinetic/pharmacodynamic or drug dosing reasons. Optimized CBPs will provide a standardized antibiotic susceptibility testing interpretation at a defined level of probability. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For

A service oriented approach for guidelines-based clinical decision support using BPMN.

Science.gov (United States)

Rodriguez-Loya, Salvador; Aziz, Ayesha; Chatwin, Chris

2014-01-01

Evidence-based medical practice requires that clinical guidelines need to be documented in such a way that they represent a clinical workflow in its most accessible form. In order to optimize clinical processes to improve clinical outcomes, we propose a Service Oriented Architecture (SOA) based approach for implementing clinical guidelines that can be accessed from an Electronic Health Record (EHR) application with a Web Services enabled communication mechanism with the Enterprise Service Bus. We have used Business Process Modelling Notation (BPMN) for modelling and presenting the clinical pathway in the form of a workflow. The aim of this study is to produce spontaneous alerts in the healthcare workflow in the diagnosis of Chronic Obstructive Pulmonary Disease (COPD). The use of BPMN as a tool to automate clinical guidelines has not been previously employed for providing Clinical Decision Support (CDS).

[Standardization of the terms for Chinese herbal functions based on functional targeting].

Science.gov (United States)

Xiao, Bin; Tao, Ou; Gu, Hao; Wang, Yun; Qiao, Yan-Jiang

2011-03-01

Functional analysis concisely summarizes and concentrates on the therapeutic characteristics and features of Chinese herbal medicine. Standardization of the terms for Chinese herbal functions not only plays a key role in modern research and development of Chinese herbal medicine, but also has far-reaching clinical applications. In this paper, a new method for standardizing the terms for Chinese herbal function was proposed. Firstly, functional targets were collected. Secondly, the pathological conditions and the mode of action of every functional target were determined by analyzing the references. Thirdly, the relationships between the pathological condition and the mode of action were determined based on Chinese medicine theory and data. This three-step approach allows for standardization of the terms for Chinese herbal functions. Promoting the standardization of Chinese medicine terms will benefit the overall clinical application of Chinese herbal medicine.

Students' approaches to learning in a clinical practicum: A psychometric evaluation based on item response theory.

Science.gov (United States)

Zhao, Yue; Kuan, Hoi Kei; Chung, Joyce O K; Chan, Cecilia K Y; Li, William H C

2018-07-01

The investigation of learning approaches in the clinical workplace context has remained an under-researched area. Despite the validation of learning approach instruments and their applications in various clinical contexts, little is known about the extent to which an individual item, that reflects a specific learning strategy and motive, effectively contributes to characterizing students' learning approaches. This study aimed to measure nursing students' approaches to learning in a clinical practicum using the Approaches to Learning at Work Questionnaire (ALWQ). Survey research design was used in the study. A sample of year 3 nursing students (n = 208) who undertook a 6-week clinical practicum course participated in the study. Factor analyses were conducted, followed by an item response theory analysis, including model assumption evaluation (unidimensionality and local independence), item calibration and goodness-of-fit assessment. Two subscales, deep and surface, were derived. Findings suggested that: (a) items measuring the deep motive from intrinsic interest and deep strategies of relating new ideas to similar situations, and that of concept mapping served as the strongest discriminating indicators; (b) the surface strategy of memorizing facts and details without an overall picture exhibited the highest discriminating power among all surface items; and, (c) both subscales appeared to be informative in assessing a broad range of the corresponding latent trait. The 21-item ALWQ derived from this study presented an efficient, internally consistent and precise measure. Findings provided a useful psychometric evaluation of the ALWQ in the clinical practicum context, added evidence to the utility of the ALWQ for nursing education practice and research, and echoed the discussions from previous studies on the role of the contextual factors in influencing student choices of different learning strategies. They provided insights for clinical educators to measure

The development of an efficient mass balance approach for the purity assignment of organic calibration standards.

Science.gov (United States)

Davies, Stephen R; Alamgir, Mahiuddin; Chan, Benjamin K H; Dang, Thao; Jones, Kai; Krishnaswami, Maya; Luo, Yawen; Mitchell, Peter S R; Moawad, Michael; Swan, Hilton; Tarrant, Greg J

2015-10-01

The purity determination of organic calibration standards using the traditional mass balance approach is described. Demonstrated examples highlight the potential for bias in each measurement and the need to implement an approach that provides a cross-check for each result, affording fit for purpose purity values in a timely and cost-effective manner. Chromatographic techniques such as gas chromatography with flame ionisation detection (GC-FID) and high-performance liquid chromatography with UV detection (HPLC-UV), combined with mass and NMR spectroscopy, provide a detailed impurity profile allowing an efficient conversion of chromatographic peak areas into relative mass fractions, generally avoiding the need to calibrate each impurity present. For samples analysed by GC-FID, a conservative measurement uncertainty budget is described, including a component to cover potential variations in the response of each unidentified impurity. An alternative approach is also detailed in which extensive purification eliminates the detector response factor issue, facilitating the certification of a super-pure calibration standard which can be used to quantify the main component in less-pure candidate materials. This latter approach is particularly useful when applying HPLC analysis with UV detection. Key to the success of this approach is the application of both qualitative and quantitative (1)H NMR spectroscopy.

Exploring Chinese cultural standards through the lens of German managers: A case study approach

Directory of Open Access Journals (Sweden)

Roger Moser

2011-06-01

Full Text Available The ability to understand one’s own culture and to deal with specificities of foreign cultures is one of the core requirements in today’s international business. Management skills are partially culture specific and a management approach that is appropriate in one cultural context may not be appropriate in another. Several business activities of companies nowadays take place abroad, which requires managers to interact with different cultures. This paper aims to analyse cultural characteristics, especially in a Sino-German business context. Based on literature analysis and case study research, relevant cultural standards in China were identified from the German perspective. The result differentiates three superordinate cultural areas and five specific cultural standards and analyses different influence factors on the dimensions of the identified Chinese cultural standards.

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

Promoting Clinical Reasoning in Undergraduate Physical Therapy Education: A Review of Strategies and Approaches

DEFF Research Database (Denmark)

Brekke, Anders Falk

2015-01-01

Title: Promoting Clinical Reasoning in Undergraduate Physical Therapy Education: A Review of Strategies and Approaches Juneja H1, Brekke A F2 1,2 Physical Therapy Education, University College Zealand, Denmark Background: Clinical reasoning (CR) also referred to as “critical thinking” or “decision....... It is imperative that physical therapy educators utilize innovative pedagogical methods to facilitate learning of reasoning skills in students. Purpose: The review is an attempt to highlight and discuss selected pedagogical strategies and approaches to enhance clinical reasoning skills in undergraduate physical...... programs was shortlisted for the review. References of pertinent literature were scanned to identify further relevant citations. Results: The review provides a detailed insight into the interwoven nature of pedagogical techniques to promote clinical reasoning being used by different physical therapy...

A systematic approach to the training in the nuclear power industry: The need for standard

International Nuclear Information System (INIS)

Wilkinson, J.D.

1995-01-01

The five elements of a open-quotes Systematic Approach to Trainingclose quotes (SAT) are analysis, design, development, implementation and evaluation. These elements are also present in the effective application of basic process control. The fundamental negative feedback process control loop is therefore an excellent model for a successful, systematic approach to training in the nuclear power industry. Just as standards are required in today's manufacturing and service industries, eg ISO 9000, so too are control standards needed in the training industry and in particular in the training of nuclear power plant staff. The International Atomic Energy Agency (IAEA) produced its TECDOC 525 on open-quotes Training to Establish and Maintain the Qualification and Competence of Nuclear Power Plant Operations Personnelclose quotes in 1989 and the American Nuclear Society published its open-quotes Selection, Qualification, and Training of Personnel for Nuclear Power Plants, an American National Standardclose quotes in 1993. It is important that community colleges, training vendors and organizations such as the Instrument Society of America (ISA), who may be supplying basic or prerequisite training to the nuclear power industry, become aware of these and other standards relating to training in the nuclear power industry

Clinical longitudinal standards for height, weight, height velocity, weight velocity, and stages of puberty.

Science.gov (United States)

Tanner, J M; Whitehouse, R H

1976-01-01

New charts for height, weight, height velocity, and weight velocity are presented for clinical (as opposed to population survey) use. They are based on longitudinal-type growth curves, using the same data as in the British 1965 growth standards. In the velocity standards centiles are given for children who are early- and late-maturing as well as for those who mature at the average age (thus extending the use of the previous charts). Limits of normality for the age of occurrence of the adolescent growth spurt are given and also for the successive stages of penis, testes, and pubic hair development in boys, and for stages of breast and pubic hair development in girls. PMID:952550

Raising standards in clinical research

DEFF Research Database (Denmark)

Ohmann, C.; Canham, S.; Demotes, J.

2017-01-01

The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were c...

Effect of International Standards Certification on Firm-Level Exports: An Application of the Control Function Approach

OpenAIRE

Tsunehiro Otsuki

2011-01-01

Growing number of firms in developing countries have earned certifications such as International Standards Organization (ISO) as it enhances reputation of their company or brand and attract buyers particularly in export market. This study evaluates the effect of international standards certification on firm's export performance in Europe and Central Asia by applying the control function approach with endogenous treatment effect to firm-level data. Certification is found to increase export sha...

Reverse breech extraction versus the standard approach of pushing the impacted fetal head up through the vagina in caesarean section for obstructed labour: A randomised controlled trial.

Science.gov (United States)

Nooh, Ahmed Mohamed; Abdeldayem, Hussein Mohammed; Ben-Affan, Othman

2017-05-01

The objective of this study was to assess effectiveness and safety of the reverse breech extraction approach in Caesarean section for obstructed labour, and compare it with the standard approach of pushing the fetal head up through the vagina. This randomised controlled trial included 192 women. In 96, the baby was delivered by the 'reverse breech extraction approach', and in the remaining 96, by the 'standard approach'. Extension of uterine incision occurred in 18 participants (18.8%) in the reverse breech extraction approach group, and 46 (47.9%) in the standard approach group (p = .0003). Two women (2.1%) in the reverse breech extraction approach group needed blood transfusion and 11 (11.5%) in the standard approach group (p = .012). Pyrexia developed in 3 participants (3.1%) in the reverse breech extraction approach group, and 19 (19.8%) in the standard approach group (p = .0006). Wound infection occurred in 2 women (2.1%) in the reverse breech extraction approach group, and 12 (12.5%) in the standard approach group (p = .007). Apgar score pushing the fetal head up through the vagina.

Evaluation of a performance-based standards approach to heavy vehicle design to reduce pavement wear

CSIR Research Space (South Africa)

Nordengen, Paul A

2013-11-01

Full Text Available As a result of successful initiatives in Australia, New Zealand and Canada, the introduction of a performance-based standards (PBS) approach in the heavy vehicle sector in South Africa was identified by the Council for Scientific and Industrial...

Multiparametric prostate MRI: technical conduct, standardized report and clinical use.

Science.gov (United States)

Manfredi, Matteo; Mele, Fabrizio; Garrou, Diletta; Walz, Jochen; Fütterer, Jurgen J; Russo, Filippo; Vassallo, Lorenzo; Villers, Arnauld; Emberton, Mark; Valerio, Massimo

2018-02-01

Multiparametric prostate MRI (mp-MRI) is an emerging imaging modality for diagnosis, characterization, staging, and treatment planning of prostate cancer (PCa). The technique, results reporting, and its role in clinical practice have been the subject of significant development over the last decade. Although mp-MRI is not yet routinely used in the diagnostic pathway, almost all urological guidelines have emphasized the potential role of mp-MRI in several aspects of PCa management. Moreover, new MRI sequences and scanning techniques are currently under evaluation to improve the diagnostic accuracy of mp-MRI. This review presents an overview of mp-MRI, summarizing the technical applications, the standardized reporting systems used, and their current roles in various stages of PCa management. Finally, this critical review also reports the main limitations and future perspectives of the technique.

A strategic approach for managing conflict in hospitals: responding to the Joint Commission leadership standard, Part 1.

Science.gov (United States)

Scott, Charity; Gerardi, Debra

2011-02-01

The Joint Commission's leadership standard for conflict management in hospitals, LD.02.04.01, states, "The hospital manages conflict between leadership groups to protect the quality and safety of care." This standard is one of numerous standards and alerts issued by The Joint Commission that address conflict and communication. They underscore the significant impact of relational dynamics on patient safety and quality of care and the critical need for a strategic approach to conflict in health care organizations. Whether leadership conflicts openly threaten a major disruption of hospital operations or whether unresolved conflicts lurk beneath the surface of daily interactions, unaddressed conflict can undermine a hospital's efforts to ensure safe, high-quality patient care. How leaders manage organizational conflict has a significant impact on achieving strategic objectives. Aligning conflict management approaches with quality and safety goals is the first step in adopting a strategic approach to conflict management. A strategic approach goes beyond reducing costs of litigation or improving grievance processes--it integrates a collaborative mind-set and individual conflict competency with nonadversarial processes. Conflict assessment should determine how conflicts are handled among the leaders at the hospital, the degree of conflict competence already present among the leaders, where the most significant conflicts occur, and how leaders think a conflict management system might work for them. Strategically aligning a conflict management approach that addresses conflict among leadership groups as a means of protecting the quality and safety of patient care is at the heart of LD.02.04.01.

Clinical transfusion practice update: haemovigilance, complications, patient blood management and national standards.

Science.gov (United States)

Engelbrecht, Sunelle; Wood, Erica M; Cole-Sinclair, Merrole F

2013-09-16

Blood transfusion is not without risk. Although the risks of HIV and hepatitis transmission have diminished, haemovigilance programs highlight that other significant transfusion hazards remain. Sepsis from bacterial contamination is the most common residual infectious hazard in developed countries, and events due to clerical error are problematic. Unnecessary transfusions should be avoided. New national guidelines on patient blood management (PBM) emphasise holistic approaches, including strategies to reduce transfusion requirements. Perioperative PBM should incorporate preoperative haemoglobin and medication optimisation, intraoperative blood conservation, and consideration of restrictive postoperative transfusion and cell-salvage techniques. When massive transfusion is required, hospitals should implement massive transfusion protocols. These protocols reduce mortality, improve communication and facilitate adequate provision of blood products. They should include multidisciplinary team involvement and guidelines for use of blood components and adjunctive agents. Although fresh frozen plasma to red blood cell and platelet to red blood cell ratios of ≥ 1 : 2 appear to reduce mortality in trauma patients who receive massive transfusion, there is insufficient evidence to recommend specific ratios. Systematic reviews have found no significant benefit of recombinant activated factor VII in critical bleeding, and an increase in thromboembolic events; specialist haematology advice is therefore recommended when considering use of this agent. The National Safety and Quality Health Service Standards address use of blood and blood products, and provide important transfusion principles for adoption by all clinicians. Storage of red cells in additive solution results in changes, known as the "storage lesion", and studies to determine the clinical effect of the age of blood at transfusion are ongoing.

A primer on standards setting as it applies to surgical education and credentialing.

Science.gov (United States)

Cendan, Juan; Wier, Daryl; Behrns, Kevin

2013-07-01

Surgical technological advances in the past three decades have led to dramatic reductions in the morbidity associated with abdominal procedures and permanently altered the surgical practice landscape. Significant changes continue apace including surgical robotics, natural orifice-based surgery, and single-incision approaches. These disruptive technologies have on occasion been injurious to patients, and high-stakes assessment before adoption of new technologies would be reasonable. We reviewed the drivers for well-established psychometric techniques available for the standards-setting process. We present a series of examples that are relevant in the surgical domain including standards setting for knowledge and skills assessments. Defensible standards for knowledge and procedural skills will likely become part of surgical clinical practice. Understanding the methodology for determining standards should position the surgical community to assist in the process and lead within their clinical settings as standards are considered that may affect patient safety and physician credentialing.

[Note on the epistemology of clinical pharmacology: comparison with the approach of Karl Popper].

Science.gov (United States)

Boissel, J P

1999-01-01

Is clinical pharmacology a science or only an application of science? Karl Popper suggested a method to identify science and to sort it out from other logical activities such as metaphysics, whereby the falsification criterion he proposed can apply to the theory in such a way that the theory could be refuted. The clinical pharmacologist's approach requires the build-up of a therapeutic model on the basis of two other models: the physiopathologic and the pharmacological. The three-model construct is a theory. Is it scientific in the Popperian sense? From the therapeutic model, one can predict the efficacy of a drug, and the corresponding statement is tested by a clinical trial. Whatever the original statement, it is modified into a refutable one because of the use of the statistical approach in clinical trials. Furthermore, the predicate represents a hypothesis of the model validity, which will then be confronted with 'reality' through clinical experiment. As the therapeutic model is refutable, clinical pharmacology is a science in the Popperian sense.

Standardization and quantification in FDG-PET/CT imaging for staging and restaging of malignant disease.

Science.gov (United States)

Gámez-Cenzano, Cristina; Pino-Sorroche, Francisco

2014-04-01

There is a growing interest in using quantification in FDG-PET/CT in oncology, especially for evaluating response to therapy. Complex full quantitative procedures with blood sampling and dynamic scanning have been clinically replaced by the use of standardized uptake value measurements that provide an index of regional tracer uptake normalized to the administered dose of FDG. Some approaches have been proposed for assessing quantitative metabolic response, such as EORTC and PERCIST criteria in solid tumors. When using standardized uptake value in clinical routine and multicenter trials, standardization of protocols and quality control procedures of instrumentation is required. Copyright © 2014 Elsevier Inc. All rights reserved.

Offering pre-exposure prophylaxis for HIV prevention to pregnant and postpartum women: a clinical approach.

Science.gov (United States)

Seidman, Dominika L; Weber, Shannon; Cohan, Deborah

2017-03-08

HIV prevention during pregnancy and lactation is critical for both maternal and child health. Pregnancy provides a critical opportunity for clinicians to elicit women's vulnerabilities to HIV and offer HIV testing, treatment and referral and/or comprehensive HIV prevention options for the current pregnancy, the postpartum period and safer conception options for future pregnancies. In this commentary, we review the safety of oral pre-exposure prophylaxis with tenofovir/emtricitabine in pregnant and lactating women and suggest opportunities to identify pregnant and postpartum women at substantial risk of HIV. We then describe a clinical approach to caring for women who both choose and decline pre-exposure prophylaxis during pregnancy and postpartum, highlighting areas for future research. Evidence suggests that pre-exposure prophylaxis with tenofovir/emtricitabine is safe in pregnancy and lactation. Identifying women vulnerable to HIV and eligible for pre-exposure prophylaxis is challenging in light of the myriad of individual, community, and structural forces impacting HIV acquisition. Validated risk calculators exist for specific populations but have not been used to screen and offer HIV prevention methods. Partner testing and engagement of men living with HIV are additional means of reaching at-risk women. However, women's vulnerabilities to HIV change over time. Combining screening for HIV vulnerability with HIV and/or STI testing at standard intervals during pregnancy is a practical way to prompt providers to incorporate HIV screening and prevention counselling. We suggest using shared decision-making to offer women pre-exposure prophylaxis as one of multiple HIV prevention strategies during pregnancy and postpartum, facilitating open conversations about HIV vulnerabilities, preferences about HIV prevention strategies, and choosing a method that best meets the needs of each woman. Growing evidence suggests that pre-exposure prophylaxis with tenofovir

Clinical Trials

Medline Plus

Full Text Available ... decisionmaking. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ... otherwise. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ...

Clinical Digital Libraries Project: design approach and exploratory assessment of timely use in clinical environments.

Science.gov (United States)

Maccall, Steven L

2006-04-01

The paper describes and evaluates the use of Clinical Digital Libraries Project (CDLP) digital library collections in terms of their facilitation of timely clinical information seeking. A convenience sample of CDLP Web server log activity over a twelve-month period (7/2002 to 6/2003) was analyzed for evidence of timely information seeking after users were referred to digital library clinical topic pages from Web search engines. Sample searches were limited to those originating from medical schools (26% North American and 19% non-North American) and from hospitals or clinics (51% North American and 4% non-North American). Timeliness was determined based on a calculation of the difference between the timestamps of the first and last Web server log "hit" during each search in the sample. The calculated differences were mapped into one of three ranges: less than one minute, one to three minutes, and three to five minutes. Of the 864 searches analyzed, 48% were less than 1 minute, 41% were 1 to 3 minutes, and 11% were 3 to 5 minutes. These results were further analyzed by environment (medical schools versus hospitals or clinics) and by geographic location (North America versus non-North American). Searches reflected a consistent pattern of less than 1 minute in these environments. Though the results were not consistent on a month-by-month basis over the entire time period, data for 8 of 12 months showed that searches shorter than 1 minute predominated and data for 1 month showed an equal number of less than 1 minute and 1 to 3 minute searches. The CDLP digital library collections provided timely access to high-quality Web clinical resources when used for information seeking in medical education and hospital or clinic environments from North American and non-North American locations and consistently provided access to the sought information within the documented two-minute standard. The limitations of the use of Web server data warrant an exploratory assessment. This

On the applicability of the standard approaches for evaluating a neoclassical radial electric field in a tokamak edge region

Energy Technology Data Exchange (ETDEWEB)

Dorf, M. A.; Cohen, R. H.; Joseph, I. [Lawrence Livermore National Laboratory, Livermore, California 94550 (United States); Simakov, A. N. [Los Alamos National Laboratory, Los Alamos, New Mexico 87544 (United States)

2013-08-15

The use of the standard approaches for evaluating a neoclassical radial electric field E{sub r}, i.e., the Ampere (or gyro-Poisson) equation, requires accurate calculation of the difference between the gyroaveraged electron and ion particle fluxes (or densities). In the core of a tokamak, the nontrivial difference appears only in high-order corrections to a local Maxwellian distribution due to the intrinsic ambipolarity of particle transport. The evaluation of such high-order corrections may be inconsistent with the accuracy of the standard long wavelength gyrokinetic equation (GKE), thus imposing limitations on the applicability of the standard approaches. However, in the edge of a tokamak, charge-exchange collisions with neutrals and prompt ion orbit losses can drive non-intrinsically ambipolar particle fluxes for which a nontrivial (E{sub r}-dependent) difference between the electron and ion fluxes appears already in a low order and can be accurately predicted by the long wavelength GKE. The parameter regimes, where the radial electric field dynamics in the tokamak edge region is dominated by the non-intrinsically ambipolar processes, thus allowing for the use of the standard approaches, are discussed.

Influenza and other respiratory viruses: standardizing disease severity in surveillance and clinical trials.

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Rath, Barbara; Conrad, Tim; Myles, Puja; Alchikh, Maren; Ma, Xiaolin; Hoppe, Christian; Tief, Franziska; Chen, Xi; Obermeier, Patrick; Kisler, Bron; Schweiger, Brunhilde

2017-06-01

Influenza-Like Illness is a leading cause of hospitalization in children. Disease burden due to influenza and other respiratory viral infections is reported on a population level, but clinical scores measuring individual changes in disease severity are urgently needed. Areas covered: We present a composite clinical score allowing individual patient data analyses of disease severity based on systematic literature review and WHO-criteria for uncomplicated and complicated disease. The 22-item ViVI Disease Severity Score showed a normal distribution in a pediatric cohort of 6073 children aged 0-18 years (mean age 3.13; S.D. 3.89; range: 0 to 18.79). Expert commentary: The ViVI Score was correlated with risk of antibiotic use as well as need for hospitalization and intensive care. The ViVI Score was used to track children with influenza, respiratory syncytial virus, human metapneumovirus, human rhinovirus, and adenovirus infections and is fully compliant with regulatory data standards. The ViVI Disease Severity Score mobile application allows physicians to measure disease severity at the point-of care thereby taking clinical trials to the next level.

Can context justify an ethical double standard for clinical research in developing countries?

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Landes Megan

2005-07-01

Full Text Available Abstract Background The design of clinical research deserves special caution so as to safeguard the rights of participating individuals. While the international community has agreed on ethical standards for the design of research, these frameworks still remain open to interpretation, revision and debate. Recently a breach in the consensus of how to apply these ethical standards to research in developing countries has occurred, notably beginning with the 1994 placebo-controlled trials to reduce maternal to child transmission of HIV-1 in Africa, Asia and the Caribbean. The design of these trials sparked intense debate with the inclusion of a placebo-control group despite the existence of a 'gold standard' and trial supporters grounded their justifications of the trial design on the context of scarcity in resource-poor settings. Discussion These 'contextual' apologetics are arguably an ethical loophole inherent in current bioethical methodology. However, this convenient appropriation of 'contextual' analysis simply fails to acknowledge the underpinnings of feminist ethical analysis upon which it must stand. A more rigorous analysis of the political, social, and economic structures pertaining to the global context of developing countries reveals that the bioethical principles of beneficence and justice fail to be met in this trial design. Conclusion Within this broader, and theoretically necessary, understanding of context, it becomes impossible to justify an ethical double standard for research in developing countries.

A direct sensitivity approach to predict hourly ozone resulting from compliance with the National Ambient Air Quality Standard.

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Simon, Heather; Baker, Kirk R; Akhtar, Farhan; Napelenok, Sergey L; Possiel, Norm; Wells, Benjamin; Timin, Brian

2013-03-05

In setting primary ambient air quality standards, the EPA's responsibility under the law is to establish standards that protect public health. As part of the current review of the ozone National Ambient Air Quality Standard (NAAQS), the US EPA evaluated the health exposure and risks associated with ambient ozone pollution using a statistical approach to adjust recent air quality to simulate just meeting the current standard level, without specifying emission control strategies. One drawback of this purely statistical concentration rollback approach is that it does not take into account spatial and temporal heterogeneity of ozone response to emissions changes. The application of the higher-order decoupled direct method (HDDM) in the community multiscale air quality (CMAQ) model is discussed here to provide an example of a methodology that could incorporate this variability into the risk assessment analyses. Because this approach includes a full representation of the chemical production and physical transport of ozone in the atmosphere, it does not require assumed background concentrations, which have been applied to constrain estimates from past statistical techniques. The CMAQ-HDDM adjustment approach is extended to measured ozone concentrations by determining typical sensitivities at each monitor location and hour of the day based on a linear relationship between first-order sensitivities and hourly ozone values. This approach is demonstrated by modeling ozone responses for monitor locations in Detroit and Charlotte to domain-wide reductions in anthropogenic NOx and VOCs emissions. As seen in previous studies, ozone response calculated using HDDM compared well to brute-force emissions changes up to approximately a 50% reduction in emissions. A new stepwise approach is developed here to apply this method to emissions reductions beyond 50% allowing for the simulation of more stringent reductions in ozone concentrations. Compared to previous rollback methods, this

A clinical approach to the diagnosis of retinal vasculitis.

Science.gov (United States)

El-Asrar, Ahmed M Abu; Herbort, Carl P; Tabbara, Khalid F

2010-04-01

Retinal vasculitis is a sight-threatening inflammatory eye condition that involves the retinal vessels. Detection of retinal vasculitis is made clinically, and is confirmed with the help of fundus fluorescein angiography. Active vascular disease is characterized by exudates around retinal vessels resulting in white sheathing or cuffing of the affected vessels. In this review, a practical approach to the diagnosis of retinal vasculitis is discussed based on ophthalmoscopic and fundus fluorescein angiographic findings.

Standardized terminology for clinical trial protocols based on top-level ontological categories.

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Heller, B; Herre, H; Lippoldt, K; Loeffler, M

2004-01-01

This paper describes a new method for the ontologically based standardization of concepts with regard to the quality assurance of clinical trial protocols. We developed a data dictionary for medical and trial-specific terms in which concepts and relations are defined context-dependently. The data dictionary is provided to different medical research networks by means of the software tool Onto-Builder via the internet. The data dictionary is based on domain-specific ontologies and the top-level ontology of GOL. The concepts and relations described in the data dictionary are represented in natural language, semi-formally or formally according to their use.

Automatic Selection of Clinical Trials Based on A Semantic Web Approach.

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Cuggia, Marc; Campillo-Gimenez, Boris; Bouzille, Guillaume; Besana, Paolo; Jouini, Wassim; Dufour, Jean-Charles; Zekri, Oussama; Gibaud, Isabelle; Garde, Cyril; Duvauferier, Regis

2015-01-01

Recruitment of patients in clinical trials is nowadays preoccupying, as the inclusion rate is particularly low. The main identified factors are the multiplicity of open clinical trials, the high number and complexity of eligibility criteria, and the additional workload that a systematic search of the clinical trials a patient could be enrolled in for a physician. The principal objective of the ASTEC project is to automate the prescreening phase during multidisciplinary meetings (MDM). This paper presents the evaluation of a computerized recruitment support systems (CRSS) based on semantic web approach. The evaluation of the system was based on data collected retrospectively from a 6 month period of MDM in Urology and on 4 clinical trials of prostate cancer. The classification performance of the ASTEC system had a precision of 21%, recall of 93%, and an error rate equal to 37%. Missing data was the main issue encountered. The system was designed to be both scalable to other clinical domains and usable during MDM process.

Teaching medical students a clinical approach to altered mental status: simulation enhances traditional curriculum

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Jeremy D. Sperling

2013-04-01

Full Text Available Introduction: Simulation-based medical education (SBME is increasingly being utilized for teaching clinical skills in undergraduate medical education. Studies have evaluated the impact of adding SBME to third- and fourth-year curriculum; however, very little research has assessed its efficacy for teaching clinical skills in pre-clerkship coursework. To measure the impact of a simulation exercise during a pre-clinical curriculum, a simulation session was added to a pre-clerkship course at our medical school where the clinical approach to altered mental status (AMS is traditionally taught using a lecture and an interactive case-based session in a small group format. The objective was to measure simulation's impact on students’ knowledge acquisition, comfort, and perceived competence with regards to the AMS patient. Methods: AMS simulation exercises were added to the lecture and small group case sessions in June 2010 and 2011. Simulation sessions consisted of two clinical cases using a high-fidelity full-body simulator followed by a faculty debriefing after each case. Student participation in a simulation session was voluntary. Students who did and did not participate in a simulation session completed a post-test to assess knowledge and a survey to understand comfort and perceived competence in their approach to AMS. Results: A total of 154 students completed the post-test and survey and 65 (42% attended a simulation session. Post-test scores were higher in students who attended a simulation session compared to those who did not (p<0.001. Students who participated in a simulation session were more comfortable in their overall approach to treating AMS patients (p=0.05. They were also more likely to state that they could articulate a differential diagnosis (p=0.03, know what initial diagnostic tests are needed (p=0.01, and understand what interventions are useful in the first few minutes (p=0.003. Students who participated in a simulation session

MATE standardization

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Farmer, R. E.

1982-11-01

The MATE (Modular Automatic Test Equipment) program was developed to combat the proliferation of unique, expensive ATE within the Air Force. MATE incorporates a standard management approach and a standard architecture designed to implement a cradle-to-grave approach to the acquisition of ATE and to significantly reduce the life cycle cost of weapons systems support. These standards are detailed in the MATE Guides. The MATE Guides assist both the Air Force and Industry in implementing the MATE concept, and provide the necessary tools and guidance required for successful acquisition of ATE. The guides also provide the necessary specifications for industry to build MATE-qualifiable equipment. The MATE architecture provides standards for all key interfaces of an ATE system. The MATE approach to the acquisition and management of ATE has been jointly endorsed by the commanders of Air Force Systems Command and Air Force Logistics Command as the way of doing business in the future.

OSCE vs. TEM: Different approaches to assess clinical skills of nursing students

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Prasuna Jelly

2017-01-01

Full Text Available Introduction: Nurses are trained with specific clinical skills, and objective structured clinical examination (OSCE could be a better approach to assess clinical skills of nursing students. Materials and Methods: A comparative study was conducted by observational checklist regarding antenatal care and opinionnaire on the usefulness of OSCE and tradition evaluation method (TEM was used to assess the clinical skills and to get opinion. Results: The mean score of OSCE was more than TEM and the difference was statistically significant (P < 0.001. The opinion of students regarding the usefulness of OSCE was higher than TEM. Conclusions: The study concluded that implementing OSCE will overweigh the advantages of the TEM.

OSTEOARTHRITIS: CURRENT CLINICAL CONCEPT AND SOME PROMISING THERAPEUTIC APPROACHES

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A. E. Karateev

2018-01-01

Full Text Available In recent years, there has been a trend toward changing the clinical concept of osteoarthritis (OA. This disease has been considered as an age-related disease and the long-term result of a current pathological process for a very long time. However, many experts are now inclined to consider it necessary to identify the early, pre-X-ray stage of OA, when adequate treatment may not only halt the progression, but also achieve the regression of joint structural changes. This review deals with a number of pathogenetic and clinical aspects of the early stages of OA, which are important for timely diagnosis and pathogenetic therapy choice. It also considers some therapeutic approaches, both a "classic" and recently actively discussed methods for using platelet-rich plasma and autologous chondrocyte transplantation.

Process-outcome interrelationship and standard setting in medical education: the need for a comprehensive approach.

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Christensen, Leif; Karle, Hans; Nystrup, Jørgen

2007-09-01

An outcome-based approach to medical education compared to a process/content orientation is currently being discussed intensively. In this article, the process and outcome interrelationship in medical education is discussed, with specific emphasis on the relation to the definition of standards in basic medical education. Perceptions of outcome have always been an integrated element of curricular planning. The present debate underlines the need for stronger focus on learning objectives and outcome assessment in many medical schools around the world. The need to maintain an integrated approach of process/content and outcome is underlined in this paper. A worry is expressed about the taxonomy of learning in pure outcome-based medical education, in which student assessment can be a major determinant for the learning process, leaving the control of the medical curriculum to medical examiners. Moreover, curricula which favour reductionism by stating everything in terms of instrumental outcomes or competences, do face a risk of lowering quality and do become a prey for political interference. Standards based on outcome alone rise unclarified problems in relationship to licensure requirements of medical doctors. It is argued that the alleged dichotomy between process/content and outcome seems artificial, and that formulation of standards in medical education must follow a comprehensive line in curricular planning.

Systematic and transparent inclusion of ethical issues and recommendations in clinical practice guidelines: a six-step approach.

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Mertz, Marcel; Strech, Daniel

2014-12-04

Clinical practice guidelines (CPGs), a core tool to foster medical professionalism, differ widely in whether and how they address disease-specific ethical issues (DSEIs), and current manuals for CPG development are silent on this issue. The implementation of an explicit method faces two core challenges: first, it adds further complexity to CPG development and requires human and financial resources. Second, in contrast to the in-depth treatment of ethical issues that is standard in bioethics, the inclusion of DSEIs in CPGs need to be more pragmatic, reductive, and simplistic, but without rendering the resulting recommendations useless or insufficiently justified. This paper outlines a six-step approach, EthicsGuide, for the systematic and transparent inclusion of ethical issues and recommendations in CPGs. The development of EthicsGuide is based on (a) methodological standards in evidence-based CPG development, (b) principles of bioethics, (c) research findings on how DSEIs are currently addressed in CPGs, and (d) findings from two proof-of-concept analyses of the EthicsGuide approach. The six steps are 1) determine the DSEI spectrum and the need for ethical recommendations; 2) develop statements on which to base ethical recommendations; 3) categorize, classify, condense, and paraphrase the statements; 4) write recommendations in a standard form; 5) validate and justify recommendations, making any necessary modifications; and 6) address consent. All six steps necessarily come into play when including DSEIs in CPGs. If DSEIs are not explicitly addressed, they are unavoidably dealt with implicitly. We believe that as ethicists gain greater involvement in decision-making about health, personal rights, or economic issues, they should make their methods transparent and replicable by other researchers; and as ethical issues become more widely reflected in CPGs, CPG developers have to learn how to address them in a methodologically adequate way. The approach proposed

Treatment in a specialised out-patient mood disorder clinic v. standard out-patient treatment in the early course of bipolar disorder

DEFF Research Database (Denmark)

Kessing, Lars Vedel; Hansen, Hanne Vibe; Hvenegaard, Anne

2013-01-01

BACKGROUND: Little is known about whether treatment in a specialised out-patient mood disorder clinic improves long-term prognosis for patients discharged from initial psychiatric hospital admissions for bipolar disorder. AIMS: To assess the effect of treatment in a specialised out-patient mood...... disorder clinic v. standard decentralised psychiatric treatment among patients discharged from one of their first three psychiatric hospital admissions for bipolar disorder. METHOD: Patients discharged from their first, second or third hospital admission with a single manic episode or bipolar disorder were...... randomised to treatment in a specialised out-patient mood disorder clinic or standard care (ClinicalTrials.gov: NCT00253071). The primary outcome measure was readmission to hospital, which was obtained from the Danish Psychiatric Central Register. RESULTS: A total of 158 patients with mania/bipolar disorder...

A new approach for modeling the peak utility impacts from a proposed CUAC standard

Energy Technology Data Exchange (ETDEWEB)

LaCommare, Kristina Hamachi; Gumerman, Etan; Marnay, Chris; Chan, Peter; Coughlin, Katie

2004-08-01

This report describes a new Berkeley Lab approach for modeling the likely peak electricity load reductions from proposed energy efficiency programs in the National Energy Modeling System (NEMS). This method is presented in the context of the commercial unitary air conditioning (CUAC) energy efficiency standards. A previous report investigating the residential central air conditioning (RCAC) load shapes in NEMS revealed that the peak reduction results were lower than expected. This effect was believed to be due in part to the presence of the squelch, a program algorithm designed to ensure changes in the system load over time are consistent with the input historic trend. The squelch applies a system load-scaling factor that scales any differences between the end-use bottom-up and system loads to maintain consistency with historic trends. To obtain more accurate peak reduction estimates, a new approach for modeling the impact of peaky end uses in NEMS-BT has been developed. The new approach decrements the system load directly, reducing the impact of the squelch on the final results. This report also discusses a number of additional factors, in particular non-coincidence between end-use loads and system loads as represented within NEMS, and their impacts on the peak reductions calculated by NEMS. Using Berkeley Lab's new double-decrement approach reduces the conservation load factor (CLF) on an input load decrement from 25% down to 19% for a SEER 13 CUAC trial standard level, as seen in NEMS-BT output. About 4 GW more in peak capacity reduction results from this new approach as compared to Berkeley Lab's traditional end-use decrement approach, which relied solely on lowering end use energy consumption. The new method has been fully implemented and tested in the Annual Energy Outlook 2003 (AEO2003) version of NEMS and will routinely be applied to future versions. This capability is now available for use in future end-use efficiency or other policy analysis

PREMs in inflammatory arthritis: from guidelines to standard practice.

Science.gov (United States)

Palmer, Deborah; Miedany, Y El

There is now a widespread realisation that patients' views are not incidental to, but essential to, achieving high-quality care. However, despite increasing awareness of its potential value, patient experience is not routinely assessed in inflammatory arthritis patients at present. In fact, use of patient-reported experience measures (PREMs) to evaluate the patients' management and the quality of services remains a challenge. In contrast with cancer and chronic obstructive pulmonary disease (COPD), adopting a PREMs approach in inflammatory arthritis patients is difficult because of a lack of tools and approach. This article discusses how the guidelines can be translated into standard clinical practice, creating a 'therapeutic alliance' between the health professional and patients. It will also present a novel tool for use of PREMs, which can be used in routine clinical care.

Impact of the site specialty of a continuity practice on students' clinical skills: performance with standardized patients.

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Pfeiffer, Carol A; Palley, Jane E; Harrington, Karen L

2010-07-01

The assessment of clinical competence and the impact of training in ambulatory settings are two issues of importance in the evaluation of medical student performance. This study compares the clinical skills performance of students placed in three types of community preceptors' offices (pediatrics, medicine, family medicine) on yearly clinical skills assessments with standardized patients. Our goal was to see if the site specialty impacted on clinical performance. The students in the study were completing a 3-year continuity preceptorship at a site representing one of the disciplines. Their performance on the four clinical skills assessments was compared. There was no significant difference in history taking, physical exam, communication, or clinical reasoning in any year (ANOVA p< or = .05) There was a small but significant difference in performance on a measure of interpersonal and interviewing skills during Years 1 and 2. The site specialty of an early clinical experience does not have a significant impact on performance of most of the skills measured by the assessments.

Clinical features and multidisciplinary approaches to dementia care

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Gr

2011-05-01

Full Text Available Jacob HG Grand¹, Sienna Caspar², Stuart WS MacDonald11Department of Psychology, University of Victoria, Victoria, BC, Canada; 2Interdisciplinary Graduate Studies, University of British Columbia, Vancouver, BC, CanadaAbstract: Dementia is a clinical syndrome of widespread progressive deterioration of cognitive abilities and normal daily functioning. These cognitive and behavioral impairments pose considerable challenges to individuals with dementia, along with their family members and caregivers. Four primary dementia classifications have been defined according to clinical and research criteria: 1 Alzheimer’s disease; 2 vascular dementias; 3 frontotemporal dementias; and 4 dementia with Lewy bodies/Parkinson’s disease dementia. The cumulative efforts of multidisciplinary healthcare teams have advanced our understanding of dementia beyond basic descriptions, towards a more complete elucidation of risk factors, clinical symptoms, and neuropathological correlates. The characterization of disease subtypes has facilitated targeted management strategies, advanced treatments, and symptomatic care for individuals affected by dementia. This review briefly summarizes the current state of knowledge and directions of dementia research and clinical practice. We provide a description of the risk factors, clinical presentation, and differential diagnosis of dementia. A summary of multidisciplinary team approaches to dementia care is outlined, including management strategies for the treatment of cognitive impairments, functional deficits, and behavioral and psychological symptoms of dementia. The needs of individuals with dementia are extensive, often requiring care beyond traditional bounds of medical practice, including pharmacologic and non-pharmacologic management interventions. Finally, advanced research on the early prodromal phase of dementia is reviewed, with a focus on change-point models, trajectories of cognitive change, and threshold models of

An analysis of clinical transition stresses experienced by dental students: A qualitative methods approach.

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Botelho, M; Gao, X; Bhuyan, S Y

2018-04-17

Stress in dental students is well established with potential psychological distress, emotional exhaustion and burnout-related symptoms. Little attention has been given to the problems encountered by dental students during the transition from theoretical or paraclinical training to the clinical environment. The aim of this study was to adopt a qualitative research methods approach to understand the perceived stressors during students' clinical transition and provide insights for curriculum planners to enhance learning. This study analysed four groups of 2nd- and 3rd-year BDS students' experiences in focus group interviews relating to their pre-clinical and clinical transitions. The interviews were recorded and transcribed verbatim, and a thematic analysis was performed using an inductive qualitative approach. Key overlapping domains identified were the transition gap and stresses. The transition gap was subclassified into knowledge and skill (hard and soft), and stresses was subcategorised into internal and external stresses. On first coming to clinics, students experienced knowledge gaps of unfamiliar clinical treatments with mismatches between knowledge acquisition and clinical exposure. Students felt incompetent owing to the stresses attributable to curriculum design, staff and the patient. This negatively affected their confidence and clinical performance. A range of challenges have been identified that will allow curriculum designer's to plan a more supportive learning experience to help students during their transition to clinical practice giving them timely knowledge, confidence and clinical performance to better prepare them for entering clinics. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Development and implementation of a competency-based clinical evaluation tool for midwifery education.

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Woeber, Kate

2018-03-22

The learning goals and evaluation strategies of competency-based midwifery programs must be explicit and well-defined. In the US, didactic learning is evaluated through a standardized certification examination, but standardized clinical competence evaluation is lacking. The Midwifery Competency Assessment Tool (MCAT) has been adapted from the International Confederation of Midwives' (ICM) "Essential Competencies" and from the American College of Nurse-Midwives' (ACNM) "Core Competencies", with student self-evaluation based on Benner's Novice-to-Expert theory. The MCAT allows for the measurement and monitoring of competence development in all domains of full-scope practice over the course of the midwifery program. Strengths of the MCAT are that it provides clear learning goals and performance evaluations for students, ensures and communicates content mapping across a curriculum, and highlights strengths and gaps in clinical opportunities at individual clinical sites and for entire programs. Challenges of the MCAT lie in balancing the number of competency items to be measured with the tedium of form completion, in ensuring the accuracy of student self-evaluation, and in determining "adequate" competence achievement when particular clinical opportunities are limited. Use of the MCAT with competency-based clinical education may facilitate a more standardized approach to clinical evaluation, as well as a more strategic approach to clinical site development and use. Copyright © 2018 Elsevier Ltd. All rights reserved.

Population-genetic approach to standardization of radiation and non-radiation factors

International Nuclear Information System (INIS)

Telnov, I.

2006-01-01

population level. Of 65 analyses of association between diseases and unfavorable effects and various genetic polymorphic systems, 27 had negative results. Other 38 had significant, i.e. positive results. Respective G.S.R.R. varied accordingly in the range from 1.2 to 2.5. Averaged G.S.R.R. for some genetic systems ranged from 1.4 to 1.9. More stable and closer values of averaged G.S.R.R. calculated for various categories of effects: pathologies due to radiation and non-radiation factors - 1.51; non-tumor (1,47) and tumor (1,54) diseases; average life expectancy - 1.34. Population-averaged or integral value of G.S.R.R. was about 1.5. This value can be used as genetic predisposition coefficient (C.G.P.) for correction in averaging of environmental population level factors. Such correction can be done by decreasing of permissible standard value by the value of C.G.P. to calculate population-genetic standard. It should be noted that population-genetic standards decrease risk of development of unfavorable consequences due to effect of environmental factors in individuals with genetic predisposition to the general population level. An important advantage of this approach is that there is no need to account for all existing variations of genetic predisposition to multiform unfavorable environmental factors

A new approach to preparation of standard LEDs for luminous intensity and flux measurement of LEDs

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Park, Seung-Nam; Park, Seongchong; Lee, Dong-Hoon

2006-09-01

This work presents an alternative approach for preparing photometric standard LEDs, which is based on a novel functional seasoning method. The main idea of our seasoning method is simultaneously monitoring the light output and the junction voltage to obtain quantitative information on the temperature dependence and the aging effect of the LED emission. We suggested a general model describing the seasoning process by taking junction temperature variation and aging effect into account and implemented a fully automated seasoning facility, which is capable of seasoning 12 LEDs at the same time. By independent measurements of the temperature dependence, we confirmed the discrepancy of the theoretical model to be less than 0.5 % and evaluate the uncertainty contribution of the functional seasoning to be less than 0.5 % for all the seasoned samples. To demonstrate assigning the reference value to a standard LED, the CIE averaged LED intensity (ALI) of the seasoned LEDs was measured with a spectroradiometer-based instrument and the measurement uncertainty was analyzed. The expanded uncertainty of the standard LED prepared by the new approach amounts to be 4 % ~ 5 % (k=2) depending on color without correction of spectral stray light in the spectroradiometer.

Streamlining cardiovascular clinical trials to improve efficiency and generalisability.

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Zannad, Faiez; Pfeffer, Marc A; Bhatt, Deepak L; Bonds, Denise E; Borer, Jeffrey S; Calvo-Rojas, Gonzalo; Fiore, Louis; Lund, Lars H; Madigan, David; Maggioni, Aldo Pietro; Meyers, Catherine M; Rosenberg, Yves; Simon, Tabassome; Stough, Wendy Gattis; Zalewski, Andrew; Zariffa, Nevine; Temple, Robert

2017-08-01

Controlled trials provide the most valid determination of the efficacy and safety of an intervention, but large cardiovascular clinical trials have become extremely costly and complex, making it difficult to study many important clinical questions. A critical question, and the main objective of this review, is how trials might be simplified while maintaining randomisation to preserve scientific integrity and unbiased efficacy assessments. Experience with alternative approaches is accumulating, specifically with registry-based randomised controlled trials that make use of data already collected. This approach addresses bias concerns while still capitalising on the benefits and efficiencies of a registry. Several completed or ongoing trials illustrate the feasibility of using registry-based controlled trials to answer important questions relevant to daily clinical practice. Randomised trials within healthcare organisation databases may also represent streamlined solutions for some types of investigations, although data quality (endpoint assessment) is likely to be a greater concern in those settings. These approaches are not without challenges, and issues pertaining to informed consent, blinding, data quality and regulatory standards remain to be fully explored. Collaboration among stakeholders is necessary to achieve standards for data management and analysis, to validate large data sources for use in randomised trials, and to re-evaluate ethical standards to encourage research while also ensuring that patients are protected. The rapidly evolving efforts to streamline cardiovascular clinical trials have the potential to lead to major advances in promoting better care and outcomes for patients with cardiovascular disease. © 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.

Clinical Digital Libraries Project: design approach and exploratory assessment of timely use in clinical environments*

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MacCall, Steven L.

2006-01-01

Objective: The paper describes and evaluates the use of Clinical Digital Libraries Project (CDLP) digital library collections in terms of their facilitation of timely clinical information seeking. Design: A convenience sample of CDLP Web server log activity over a twelve-month period (7/2002 to 6/2003) was analyzed for evidence of timely information seeking after users were referred to digital library clinical topic pages from Web search engines. Sample searches were limited to those originating from medical schools (26% North American and 19% non-North American) and from hospitals or clinics (51% North American and 4% non-North American). Measurement: Timeliness was determined based on a calculation of the difference between the timestamps of the first and last Web server log “hit” during each search in the sample. The calculated differences were mapped into one of three ranges: less than one minute, one to three minutes, and three to five minutes. Results: Of the 864 searches analyzed, 48% were less than 1 minute, 41% were 1 to 3 minutes, and 11% were 3 to 5 minutes. These results were further analyzed by environment (medical schools versus hospitals or clinics) and by geographic location (North America versus non-North American). Searches reflected a consistent pattern of less than 1 minute in these environments. Though the results were not consistent on a month-by-month basis over the entire time period, data for 8 of 12 months showed that searches shorter than 1 minute predominated and data for 1 month showed an equal number of less than 1 minute and 1 to 3 minute searches. Conclusions: The CDLP digital library collections provided timely access to high-quality Web clinical resources when used for information seeking in medical education and hospital or clinic environments from North American and non–North American locations and consistently provided access to the sought information within the documented two-minute standard. The limitations of the use of

Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

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Education Development Center, Inc., Newton, MA.

The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

Combining macula clinical signs and patient characteristics for age-related macular degeneration diagnosis: a machine learning approach.

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Fraccaro, Paolo; Nicolo, Massimo; Bonetto, Monica; Giacomini, Mauro; Weller, Peter; Traverso, Carlo Enrico; Prosperi, Mattia; OSullivan, Dympna

2015-01-27

To investigate machine learning methods, ranging from simpler interpretable techniques to complex (non-linear) "black-box" approaches, for automated diagnosis of Age-related Macular Degeneration (AMD). Data from healthy subjects and patients diagnosed with AMD or other retinal diseases were collected during routine visits via an Electronic Health Record (EHR) system. Patients' attributes included demographics and, for each eye, presence/absence of major AMD-related clinical signs (soft drusen, retinal pigment epitelium, defects/pigment mottling, depigmentation area, subretinal haemorrhage, subretinal fluid, macula thickness, macular scar, subretinal fibrosis). Interpretable techniques known as white box methods including logistic regression and decision trees as well as less interpreitable techniques known as black box methods, such as support vector machines (SVM), random forests and AdaBoost, were used to develop models (trained and validated on unseen data) to diagnose AMD. The gold standard was confirmed diagnosis of AMD by physicians. Sensitivity, specificity and area under the receiver operating characteristic (AUC) were used to assess performance. Study population included 487 patients (912 eyes). In terms of AUC, random forests, logistic regression and adaboost showed a mean performance of (0.92), followed by SVM and decision trees (0.90). All machine learning models identified soft drusen and age as the most discriminating variables in clinicians' decision pathways to diagnose AMD. Both black-box and white box methods performed well in identifying diagnoses of AMD and their decision pathways. Machine learning models developed through the proposed approach, relying on clinical signs identified by retinal specialists, could be embedded into EHR to provide physicians with real time (interpretable) support.

Managing Cardiovascular Disease Risk in Rheumatoid Arthritis: Clinical Updates and Three Strategic Approaches.

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Chodara, Ann M; Wattiaux, Aimée; Bartels, Christie M

2017-04-01

ᅟ: The increase in cardiovascular disease (CVD) risk in rheumatoid arthritis (RA) is well known; however, appropriate management of this elevated risk in rheumatology clinics is less clear. By critically reviewing literature published within the past 5 years, we aim to clarify current knowledge and gaps regarding CVD risk management in RA. We examine recent guidelines, recommendations, and evidence and discuss three approaches: (1) RA-specific management including treat-to-target and medication management, (2) assessment of comprehensive individual risk, and (3) targeting traditional CVD risk factors (hypertension, smoking, hyperlipidemia, diabetes, obesity, and physical inactivity) at a population level. Considering that 75% of US RA visits occur in specialty clinics, further research is needed regarding evidence-based strategies to manage and reduce CVD risk in RA. This review highlights clinical updates including US cardiology and international professional society guidelines, successful evidence-based population approaches from primary care, and novel opportunities in rheumatology care to reduce CVD risk in RA.

Mid-level healthcare personnel training: an evaluation of the revised, nationally-standardized, pre-service curriculum for clinical officers in Mozambique.

Directory of Open Access Journals (Sweden)

Caryl Feldacker

Full Text Available Mozambique suffers from a critical shortage of healthcare workers. Mid-level healthcare workers, (Tecnicos de Medicina Geral (TMG, in Mozambique require less money and time to train than physicians. From 2009-2010, the Mozambique Ministry of Health (MoH and the International Training and Education Center for Health (I-TECH, University of Washington, Seattle, revised the TMG curriculum. To evaluate the effect of the curriculum revision, we used mixed methods to determine: 1 if TMGs meet the MoH's basic standards of clinical competency; and 2 do scores on measurements of clinical knowledge, physical exam, and clinical case scenarios differ by curriculum?T-tests of differences in means examined differences in continuous score variables between curriculum groups. Univariate and multivariate linear regression models assess curriculum-related and demographic factors associated with assessment scores on each of the three evaluation methods at the p<0.05 level. Qualitative interviews and focus groups inform interpretation.We found no significant differences in sex, marital status and age between the 112 and 189 TMGs in initial and revised curriculum, respectively. Mean scores at graduation of initial curriculum TMGs were 56.7%, 63.5%, and 49.1% on the clinical cases, knowledge test, and physical exam, respectively. Scores did not differ significantly from TMGs in the revised curriculum. Results from linear regression models find that training institute was the most significant predictor of TMG scores on both the clinical cases and physical exam.TMGs trained in either curriculum may be inadequately prepared to provide quality care. Curriculum changes are a necessary, but insufficient, part of improving TMG knowledge and skills overall. A more comprehensive, multi-level approach to improving TMG training that includes post-graduation mentoring, strengthening the pre-service internship training, and greater resources for training institute faculty may

Designing a Clinical Framework to Guide Gross Motor Intervention Decisions for Infants and Young Children with Hypotonia

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Darrah, Johanna; O'Donnell, Maureen; Lam, Joyce; Story, Maureen; Wickenheiser, Diane; Xu, Kaishou; Jin, Xiaokun

2013-01-01

Clinical practice frameworks are a valuable component of clinical education, promoting informed clinical decision making based on the best available evidence and/or clinical experience. They encourage standardized intervention approaches and evaluation of practice. Based on an international project to support the development of an enhanced service…

STANDARDISED CLINICAL EXAMINATION OF SOFT-TISSUE PAIN IN PATIENTS WITH HIP DYSPLASIA USING THE CLINICAL ENTITIES APPROACH

DEFF Research Database (Denmark)

Jacobsen, Julie Sandell; Hölmich, Per; Thorborg, Kristian

2016-01-01

Introduction In patients with symptomatic hip dysplasia soft-tissue pain may be a prevalent condition that might affect the outcome of periacetabular osteotomy (PAO). However, the distribution of soft-tissue pain in hip dysplasia has never been examined systematically using a standardised...... and reliable protocol. The aim of this study was to investigate five clinical entities in 100 patients with hip dysplasia using the clinical entities approach identifying the anatomic location of soft-tissue pain. The first 50 patients are presented in this paper. Material and Methods Fifty patients (10 males...... prevalence in the iliopsoas and the hip abductors. This indicates that patients with hip dysplasia also experience pain related to the surrounding soft-tissues, and not only from the hip joint. References (1) Holmich P, Holmich LR, Bjerg AM. Clinical examination of athletes with groin pain: an intraobserver...

Conceptual Explanation for the Algebra in the Noncommutative Approach to the Standard Model

International Nuclear Information System (INIS)

Chamseddine, Ali H.; Connes, Alain

2007-01-01

The purpose of this Letter is to remove the arbitrariness of the ad hoc choice of the algebra and its representation in the noncommutative approach to the standard model, which was begging for a conceptual explanation. We assume as before that space-time is the product of a four-dimensional manifold by a finite noncommmutative space F. The spectral action is the pure gravitational action for the product space. To remove the above arbitrariness, we classify the irreducible geometries F consistent with imposing reality and chiral conditions on spinors, to avoid the fermion doubling problem, which amounts to have total dimension 10 (in the K-theoretic sense). It gives, almost uniquely, the standard model with all its details, predicting the number of fermions per generation to be 16, their representations and the Higgs breaking mechanism, with very little input

A team-based approach to autopsy education: integrating anatomic and clinical pathology at the rotation level.

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Hébert, Tiffany Michele; Maleki, Sara; Vasovic, Ljiljana V; Arnold, Jeffrey L; Steinberg, Jacob J; Prystowsky, Michael B

2014-03-01

Pathology residency training programs should aim to teach residents to think beyond the compartmentalized data of specific rotations and synthesize data in order to understand the whole clinical picture when interacting with clinicians. To test a collaborative autopsy procedure at Montefiore Medical Center (Bronx, New York), linking residents and attending physicians from anatomic and clinical pathology in the autopsy process from the initial chart review to the final report. Residents consult with clinical pathology colleagues regarding key clinical laboratory findings during the autopsy. This new procedure serves multiple functions: creating a team-based, mutually beneficial educational experience; actively teaching consultative skills; and facilitating more in-depth analysis of the clinical laboratory findings in autopsies. An initial trial of the team-based autopsy system was done from November 2010 to December 2012. Residents were then surveyed via questionnaire to evaluate the frequency and perceived usefulness of clinical pathology autopsy consultations. Senior residents were the most frequent users of clinical pathology autopsy consultation. The most frequently consulted services were microbiology and chemistry. Eighty-nine percent of the residents found the clinical pathology consultation to be useful in arriving at a final diagnosis and clinicopathologic correlation. The team-based autopsy is a novel approach to integration of anatomic and clinical pathology curricula at the rotation level. Residents using this approach develop a more holistic approach to pathology, better preparing them for meaningful consultative interaction with clinicians. This paradigm shift in training positions us to better serve in our increasing role as arbiters of outcomes measures in accountable care organizations.

A multidisciplinary three-phase approach to improve the clinical utility of patient safety indicators.

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Najjar, Peter; Kachalia, Allen; Sutherland, Tori; Beloff, Jennifer; David-Kasdan, Jo Ann; Bates, David W; Urman, Richard D

2015-01-01

The AHRQ Patient Safety Indicators (PSIs) are used for calculation of risk-adjusted postoperative rates for adverse events. The payers and quality consortiums are increasingly requiring public reporting of hospital performance on these metrics. We discuss processes designed to improve the accuracy and clinical utility of PSI reporting in practice. The study was conducted at a 793-bed tertiary care academic medical center where PSI processes have been aggressively implemented to track patient safety events at discharge. A three-phased approach to improving administrative data quality was implemented. The initiative consisted of clinical review of all PSIs, documentation improvement, and provider outreach including active querying for patient safety events. This multidisciplinary effort to develop a streamlined process for PSI calculation reduced the reporting of miscoded PSIs and increased the clinical utility of PSI monitoring. Over 4 quarters, 4 of 41 (10%) PSI-11 and 9 of 138 (7%) PSI-15 errors were identified on review of clinical documentation and appropriate adjustments were made. A multidisciplinary, phased approach leveraging existing billing infrastructure for robust metric coding, ongoing clinical review, and frontline provider outreach is a novel and effective way to reduce the reporting of false-positive outcomes and improve the clinical utility of PSIs.

Using the time and motion method to study clinical work processes and workflow: methodological inconsistencies and a call for standardized research.

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Zheng, Kai; Guo, Michael H; Hanauer, David A

2011-01-01

To identify ways for improving the consistency of design, conduct, and results reporting of time and motion (T&M) research in health informatics. We analyzed the commonalities and divergences of empirical studies published 1990-2010 that have applied the T&M approach to examine the impact of health IT implementation on clinical work processes and workflow. The analysis led to the development of a suggested 'checklist' intended to help future T&M research produce compatible and comparable results. We call this checklist STAMP (Suggested Time And Motion Procedures). STAMP outlines a minimum set of 29 data/ information elements organized into eight key areas, plus three supplemental elements contained in an 'Ancillary Data' area, that researchers may consider collecting and reporting in their future T&M endeavors. T&M is generally regarded as the most reliable approach for assessing the impact of health IT implementation on clinical work. However, there exist considerable inconsistencies in how previous T&M studies were conducted and/or how their results were reported, many of which do not seem necessary yet can have a significant impact on quality of research and generalisability of results. Therefore, we deem it is time to call for standards that can help improve the consistency of T&M research in health informatics. This study represents an initial attempt. We developed a suggested checklist to improve the methodological and results reporting consistency of T&M research, so that meaningful insights can be derived from across-study synthesis and health informatics, as a field, will be able to accumulate knowledge from these studies.

Diagnosis of flexible flatfoot in children: a systematic clinical approach.

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Benedetti, Maria Grazia; Ceccarelli, Francesco; Berti, Lisa; Luciani, Deianira; Catani, Fabio; Boschi, Marco; Giannini, Sandro

2011-01-01

The goal of this study was to provide measures of symptoms and signs in a consecutive case series of children with flexible flatfoot based on a systematic clinical approach. Fifty-three children (age range, 10-14 years) previously diagnosed with flexible flatfoot were evaluated by a structured interview and clinical assessment. Most patients had foot symptoms (65.3% of feet) and functional limitation (68.3%). Symptoms included a sensation of discomfort (11.3%), such as early tiredness or difficulties during prolonged standing or walking, and pain (54%), mostly located in the plantar aspect of the foot (28.7%) and the medial hindfoot (18.8%). Body mass index was positively correlated to the presence of symptoms and their severity. Even if an enlarged footprint was present in 93.1% of feet, objective assessment evidenced the presence of heel valgus only in 83% of feet. Forefoot adduction was present in 22% of feet. Jack's test provided varus correction in only 54% of feet. Internal knee rotation was the most common associated disalignment, present in 43.6% of limbs. Symptoms were significantly correlated to knee alignment, and functional limitation was correlated to heel valgus. Standing balance on 1 leg was significantly correlated to footprint grading severity. A systematic clinical approach to assess children with flexible flatfoot should always be recommended for the correct diagnosis and the associated treatment management based on symptoms, functional limitation, and foot dysfunction. Functional assessment by specific tests should be included in the examination, as evidence exists that morphology and function are not necessarily related. Copyright 2011, SLACK Incorporated.

Sequential boundaries approach in clinical trials with unequal allocation ratios

Directory of Open Access Journals (Sweden)

Ayatollahi Seyyed

2006-01-01

Full Text Available Abstract Background In clinical trials, both unequal randomization design and sequential analyses have ethical and economic advantages. In the single-stage-design (SSD, however, if the sample size is not adjusted based on unequal randomization, the power of the trial will decrease, whereas with sequential analysis the power will always remain constant. Our aim was to compare sequential boundaries approach with the SSD when the allocation ratio (R was not equal. Methods We evaluated the influence of R, the ratio of the patients in experimental group to the standard group, on the statistical properties of two-sided tests, including the two-sided single triangular test (TT, double triangular test (DTT and SSD by multiple simulations. The average sample size numbers (ASNs and power (1-β were evaluated for all tests. Results Our simulation study showed that choosing R = 2 instead of R = 1 increases the sample size of SSD by 12% and the ASN of the TT and DTT by the same proportion. Moreover, when R = 2, compared to the adjusted SSD, using the TT or DTT allows to retrieve the well known reductions of ASN observed when R = 1, compared to SSD. In addition, when R = 2, compared to SSD, using the TT and DTT allows to obtain smaller reductions of ASN than when R = 1, but maintains the power of the test to its planned value. Conclusion This study indicates that when the allocation ratio is not equal among the treatment groups, sequential analysis could indeed serve as a compromise between ethicists, economists and statisticians.

Preliminary comparison of the endoscopic transnasal vs the sublabial transseptal approach for clinically nonfunctioning pituitary macroadenomas.

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Sheehan, M T; Atkinson, J L; Kasperbauer, J L; Erickson, B J; Nippoldt, T B

1999-07-01

To assess the advantages and disadvantages of an endoscopic transnasal approach to pituitary surgery for a select group of clinically nonfunctioning macroadenomas and to compare results of this approach with the sublabial transseptal approach at a single institution. We retrospectively reviewed the records of 26 patients with clinically nonfunctioning pituitary macroadenomas approached endoscopically and 44 matched control patients with the same tumors approached sublabially between January 1, 1995, and October 31, 1997. At baseline, the groups were not significantly different for age, sex distribution, number of comorbid conditions, visual field defects, degree of anterior pituitary insufficiency, or preoperative assessment of tumor volume or invasiveness. Mean (SD) operative times were significantly reduced in the endoscopic group vs the sublabial group: 2.7 (0.7) hours vs 3.4 (0.9) hours (P working channel to the sella turcica. For these reasons, the endoscopic approach or its variation is an alternative to the sublabial approach but should be considered only by experienced pituitary neurosurgeons.

Crew awareness as key to optimizing habitability standards onboard naval platforms: A 'back-to-basics' approach.

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Neelakantan, Anand; Ilankumaran, Mookkiah; Ray, Sougat

2017-10-01

A healthy habitable environment onboard warships is vital to operational fleet efficiency and fit sea-warrier force. Unique man-machine-armament interface issues and consequent constraints on habitability necessitate a multi-disciplinary approach toward optimizing habitability standards. Study of the basic 'human factor', including crew awareness on what determines shipboard habitability, and its association with habitation specifications is an essential step in such an approach. The aim of this study was to assess crew awareness on shipboard habitability and the association between awareness and maintenance of optimal habitability as per specifications. A cross-sectional descriptive study was carried out among 552 naval personnel onboard warships in Mumbai. Data on crew awareness on habitability was collected using a standardized questionnaire, and correlated with basic habitability requirement specifications. Data was analyzed using Microsoft Excel, Epi-info, and SPSS version 17. Awareness level on basic habitability aspects was very good in 65.3% of crew. Area-specific awareness was maximum with respect to living area (95.3%). Knowledge levels on waste management were among the lowest (65.2%) in the category of aspect-wise awareness. Statistically significant association was found between awareness levels and habitability standards (OR = 7.27). The new benchmarks set in the form of high crew awareness levels on basic shipboard habitability specifications and its significant association with standards needs to be sustained. It entails re-iteration of healthy habitation essentials into training; and holds the key to a fit fighting force.

Computational Approach to Annotating Variants of Unknown Significance in Clinical Next Generation Sequencing.

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Schulz, Wade L; Tormey, Christopher A; Torres, Richard

2015-01-01

Next generation sequencing (NGS) has become a common technology in the clinical laboratory, particularly for the analysis of malignant neoplasms. However, most mutations identified by NGS are variants of unknown clinical significance (VOUS). Although the approach to define these variants differs by institution, software algorithms that predict variant effect on protein function may be used. However, these algorithms commonly generate conflicting results, potentially adding uncertainty to interpretation. In this review, we examine several computational tools used to predict whether a variant has clinical significance. In addition to describing the role of these tools in clinical diagnostics, we assess their efficacy in analyzing known pathogenic and benign variants in hematologic malignancies. Copyright© by the American Society for Clinical Pathology (ASCP).

Analyzing Statistical Mediation with Multiple Informants: A New Approach with an Application in Clinical Psychology.

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Papa, Lesther A; Litson, Kaylee; Lockhart, Ginger; Chassin, Laurie; Geiser, Christian

2015-01-01

Testing mediation models is critical for identifying potential variables that need to be targeted to effectively change one or more outcome variables. In addition, it is now common practice for clinicians to use multiple informant (MI) data in studies of statistical mediation. By coupling the use of MI data with statistical mediation analysis, clinical researchers can combine the benefits of both techniques. Integrating the information from MIs into a statistical mediation model creates various methodological and practical challenges. The authors review prior methodological approaches to MI mediation analysis in clinical research and propose a new latent variable approach that overcomes some limitations of prior approaches. An application of the new approach to mother, father, and child reports of impulsivity, frustration tolerance, and externalizing problems (N = 454) is presented. The results showed that frustration tolerance mediated the relationship between impulsivity and externalizing problems. The new approach allows for a more comprehensive and effective use of MI data when testing mediation models.

A computational framework for converting textual clinical diagnostic criteria into the quality data model.

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Hong, Na; Li, Dingcheng; Yu, Yue; Xiu, Qiongying; Liu, Hongfang; Jiang, Guoqian

2016-10-01

Constructing standard and computable clinical diagnostic criteria is an important but challenging research field in the clinical informatics community. The Quality Data Model (QDM) is emerging as a promising information model for standardizing clinical diagnostic criteria. To develop and evaluate automated methods for converting textual clinical diagnostic criteria in a structured format using QDM. We used a clinical Natural Language Processing (NLP) tool known as cTAKES to detect sentences and annotate events in diagnostic criteria. We developed a rule-based approach for assigning the QDM datatype(s) to an individual criterion, whereas we invoked a machine learning algorithm based on the Conditional Random Fields (CRFs) for annotating attributes belonging to each particular QDM datatype. We manually developed an annotated corpus as the gold standard and used standard measures (precision, recall and f-measure) for the performance evaluation. We harvested 267 individual criteria with the datatypes of Symptom and Laboratory Test from 63 textual diagnostic criteria. We manually annotated attributes and values in 142 individual Laboratory Test criteria. The average performance of our rule-based approach was 0.84 of precision, 0.86 of recall, and 0.85 of f-measure; the performance of CRFs-based classification was 0.95 of precision, 0.88 of recall and 0.91 of f-measure. We also implemented a web-based tool that automatically translates textual Laboratory Test criteria into the QDM XML template format. The results indicated that our approaches leveraging cTAKES and CRFs are effective in facilitating diagnostic criteria annotation and classification. Our NLP-based computational framework is a feasible and useful solution in developing diagnostic criteria representation and computerization. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical practice guidelines: 2004 standards, options and recommendations for the management of patient with adenocarcinoma of the stomach - radiotherapy

International Nuclear Information System (INIS)

Ychou, M.; Duffour, J.; Lemanski, C.; Masson, B.; Gory-Delabaere, G.; Bosquet, L.; Blanc, P.; Giovannini, M.; Monge, G.; Guillemin, F.; Marchal, F.; Conroy, T.; Merrouche, Y.; Adenis, A.; Bosset, J.F.; Bouche, O.; Pezet, D.; Triboulet, J.P.

2004-01-01

Context. - The 'Standards, Options and Recommendations' (SOR) project, started in 1993, is a collaboration between the Federation of French Cancer Centers (FNCLCC), the 20 French regional cancer centers, and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. Objectives. - To elaborate clinical practice guidelines for patients with stomach adenocarcinoma. These recommendations cover the diagnosis, treatment and follow-up of these tumors. Methods. - The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. The Standards, Options and Recommendations are thus based on the best available evidence and expert agreement. Results. - Adjuvant radiation therapy alone is not a standard treatment for patients with stomach adenocarcinoma. Adjuvant concomitant chemoradiotherapy is not a standard treatment for patients with stage II or III stomach adenocarcinoma R0, with D1 or D2 lymphadenectomy who have undergone surgery. Following surgical resection, adjuvant concomitant chemoradiotherapy should be proposed to patients without de-nutrition with a lymphadenectomy < D1 (fewer than 15 lymph nodes examined) and those with T3 and/or N+ tumours following the protocol used in the MacDonald trials (SWOG-9008) (Level of evidence B1). Adjuvant concomitant chemoradiotherapy can be administered to patients without de-nutrition with D1 or D2 lymphadenectomy and with involvement of regional lymph nodes (N2 or N3). (authors)

Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association.

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Garber, Jeffrey R; Cobin, Rhoda H; Gharib, Hossein; Hennessey, James V; Klein, Irwin; Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Singer, Peter A; Woeber, Kenneth A

2012-12-01

Hypothyroidism has multiple etiologies and manifestations. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions. This paper describes evidence-based clinical guidelines for the clinical management of hypothyroidism in ambulatory patients. The development of these guidelines was commissioned by the American Association of Clinical Endocrinologists (AACE) in association with American Thyroid Association (ATA). AACE and the ATA assembled a task force of expert clinicians who authored this article. The authors examined relevant literature and took an evidence-based medicine approach that incorporated their knowledge and experience to develop a series of specific recommendations and the rationale for these recommendations. The strength of the recommendations and the quality of evidence supporting each was rated according to the approach outlined in the American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Guidelines-2010 update. Topics addressed include the etiology, epidemiology, clinical and laboratory evaluation, management, and consequences of hypothyroidism. Screening, treatment of subclinical hypothyroidism, pregnancy, and areas for future research are also covered. Fifty-two evidence-based recommendations and subrecommendations were developed to aid in the care of patients with hypothyroidism and to share what the authors believe is current, rational, and optimal medical practice for the diagnosis and care of hypothyroidism. A serum thyrotropin is the single best screening test for primary thyroid dysfunction for the vast majority of outpatient clinical situations. The standard treatment is replacement with L-thyroxine. The decision to treat subclinical hypothyroidism when the serum thyrotropin is less than 10 mIU/L should be tailored to the individual patient.

In search of standards to support circularity in product policies: A systematic approach.

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Tecchio, Paolo; McAlister, Catriona; Mathieux, Fabrice; Ardente, Fulvio

2017-12-01

The aspiration of a circular economy is to shift material flows toward a zero waste and pollution production system. The process of shifting to a circular economy has been initiated by the European Commission in their action plan for the circular economy. The EU Ecodesign Directive is a key policy in this transition. However, to date the focus of access to market requirements on products has primarily been upon energy efficiency. The absence of adequate metrics and standards has been a key barrier to the inclusion of resource efficiency requirements. This paper proposes a framework to boost sustainable engineering and resource use by systematically identifying standardization needs and features. Standards can then support the setting of appropriate material efficiency requirements in EU product policy. Three high-level policy goals concerning material efficiency of products were identified: embodied impact reduction, lifetime extension and residual waste reduction. Through a lifecycle perspective, a matrix of interactions among material efficiency topics (recycled content, re-used content, relevant material content, durability, upgradability, reparability, re-manufacturability, reusability, recyclability, recoverability, relevant material separability) and policy goals was created. The framework was tested on case studies for electronic displays and washing machines. For potential material efficiency requirements, specific standardization needs were identified, such as adequate metrics for performance measurements, reliable and repeatable tests, and calculation procedures. The proposed novel framework aims to provide a method by which to identify key material efficiency considerations within the policy context, and to map out the generic and product-specific standardisation needs to support ecodesign. Via such an approach, many different stakeholders (industry, academics, policy makers, non-governmental organizations etc.) can be involved in material efficiency

[Clinical effects of Dynesys system and transfacet decompression through Wiltse approach in the treatment of lumbar degenerative diseases].

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Shang, K; Chen, M J; Wang, D G

2017-05-23

Objective: To investigate the early clinical effects of Dynesys system and transfacet decompression by Wiltse approach in the treatment of lumbar degenerative diseases. Methods: From January 2010 to December 2013, 48 patients suffering from lumbar degenerative diseases were treated with Dynesys system in addition to transfacet decompression through Wiltse approach.There were 28 males and 20 females with age of (51.8±6.8). The preoperative diagnosis included lumbar spinal stenosis(10 cases); lumber intervertebral disc herniation (38 cases). There were 23 cases in L4/5, 16 cases in L5/S1 and 9 cases in both of L4/5 and L5/S1.Posterolateral fixation with Dynesys pedicle screw through Wiltse approach.Unilateral resection of the inferior articular facet of the superior vertebra and the superior articular facet of the inferior vertebra.Decompression of the vertebral canal until the never root was decompressed satisfactorily.In the end, Dynesys was performed according to normal procedure.VAS, ODI evaluating standards were applied to evaluate the therapeutic effect.The intervertebral space and ROM of the lumbar were observed by X ray. Results: All patients underwent surgery safely without severe complications occurred.The average following up time was 33.5 (24-60) months.Compared with preoperative parameters (7.7±1.3, 70.8±13.5), the scores of VAS and ODI decreased significantly after surgery (2.3±1.5, 23.6±12.2) and at the final follow-up (2.2±1.4, 20.0±9.8) ( P 0.05). X-ray scan showed neither instability or internal fixation loosen, breakage or distortion in follow-up. Conclusion: Dynesys system in addition to transfacet decompression through Wiltse approach is a therapy option for mild lumbar degenerative disease.This method can retention the structure of lumbar posterior complex and the activity of the fixed segment, reduce the risk of low back pain together with nerve root decompressed.The early clinical results are satisfactory.

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.

Automated realtime data import for the i2b2 clinical data warehouse: introducing the HL7 ETL cell.

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Majeed, Raphael W; Röhrig, Rainer

2012-01-01

Clinical data warehouses are used to consolidate all available clinical data from one or multiple organizations. They represent an important source for clinical research, quality management and controlling. Since its introduction, the data warehouse i2b2 gathered a large user base in the research community. Yet, little work has been done on the process of importing clinical data into data warehouses using existing standards. In this article, we present a novel approach of utilizing the clinical integration server as data source, commonly available in most hospitals. As information is transmitted through the integration server, the standardized HL7 message is immediately parsed and inserted into the data warehouse. Evaluation of import speeds suggest feasibility of the provided solution for real-time processing of HL7 messages. By using the presented approach of standardized data import, i2b2 can be used as a plug and play data warehouse, without the hurdle of customized import for every clinical information system or electronic medical record. The provided solution is available for download at http://sourceforge.net/projects/histream/.

Differences in Approach between Nuclear and Conventional Seismic Standards with regard to Hazard Definition - CSNI Integrity And Ageing Working Group

International Nuclear Information System (INIS)

Djaoudi, Ali; Labbe, Pierre; Murphy, Andrew; Kitada, Yoshio

2008-01-01

The Committee on the safety of Nuclear Installations (CSNI) of the OECD-NEA co-ordinates the NEA activities related to maintaining and advancing the scientific and technological knowledge base of the safety of nuclear installations. The Integrity and Ageing of Components and Structures Working Group of the CSNI is responsible for work related to the development and use of methods, data and information to assess the behaviour of materials and structures. It has three sub-groups, dealing with the integrity of metal components and structures, ageing of concrete structures, and the seismic behaviour of structures. The CSNI, at its meeting in June 2003, agreed to initiate an activity aimed to identify any difference between nuclear and non-nuclear conventional standards and their potential significance with regard to seismic hazards and design methods. There was a perception, mainly in some of the European countries that nuclear seismic hazard and design standards may be lagging behind developments in similar standards for conventional facilities. Adequate answer to such perception, need the examination of the following aspects and their significance on the seismic assessment of structures and components: - The safety philosophy behind the seismic nuclear and conventional standards. - The differences in approach regarding the seismic hazard definition. - The difference in approach regarding the design and the methods of analysis. These topics are examined in this report. Appendices A to H of this report contain a brief description of the conventional and the nuclear approaches in the NEA member countries: Belgium, Canada, Czech Republic, Germany, Japan, South Korea, Spain,and USA. The following general conclusions can be drawn: - The approach adopted by the nuclear seismic standards is more conservative and more reliable (in particular for meeting the continued operation criteria) than the recommended by the currently applicable force based conventional seismic codes

A Generalized Form of Context-Dependent Psychophysiological Interactions (gPPI): A Comparison to Standard Approaches

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McLaren, Donald G.; Ries, Michele L.; Xu, Guofan; Johnson, Sterling C.

2012-01-01

Functional MRI (fMRI) allows one to study task-related regional responses and task-dependent connectivity analysis using psychophysiological interaction (PPI) methods. The latter affords the additional opportunity to understand how brain regions interact in a task-dependent manner. The current implementation of PPI in Statistical Parametric Mapping (SPM8) is configured primarily to assess connectivity differences between two task conditions, when in practice fMRI tasks frequently employ more than two conditions. Here we evaluate how a generalized form of context-dependent PPI (gPPI; http://www.nitrc.org/projects/gppi), which is configured to automatically accommodate more than two task conditions in the same PPI model by spanning the entire experimental space, compares to the standard implementation in SPM8. These comparisons are made using both simulations and an empirical dataset. In the simulated dataset, we compare the interaction beta estimates to their expected values and model fit using the Akaike Information Criterion (AIC). We found that interaction beta estimates in gPPI were robust to different simulated data models, were not different from the expected beta value, and had better model fits than when using standard PPI (sPPI) methods. In the empirical dataset, we compare the model fit of the gPPI approach to sPPI. We found that the gPPI approach improved model fit compared to sPPI. There were several regions that became non-significant with gPPI. These regions all showed significantly better model fits with gPPI. Also, there were several regions where task-dependent connectivity was only detected using gPPI methods, also with improved model fit. Regions that were detected with all methods had more similar model fits. These results suggest that gPPI may have greater sensitivity and specificity than standard implementation in SPM. This notion is tempered slightly as there is no gold standard; however, data simulations with a known outcome support our

Clinical Comparison of Extensile Lateral Approach and Sinus Tarsi Approach Combined with Medial Distraction Technique for Intra-Articular Calcaneal Fractures.

Science.gov (United States)

Zhou, Hai-Chao; Yu, Tao; Ren, Hao-Yang; Li, Bing; Chen, Kai; Zhao, You-Guang; Yang, Yun-Feng

2017-02-01

To study and compare the clinical outcomes of open reduction and internal fixation via extensile L-shape incision and limited open reduction via the sinus tarsi approach using the medial distraction technique for intra-articular calcaneal fractures. We performed a retrospective review of 65 intra-articular calcaneal fractures treated operatively between March 2012 and February 2015. Patients were divided into two groups: 28 were in the sinus tarsi approach group and 37 were in the extensile lateral approach group. All patients were asked to return for a research visit that included radiography and clinical evaluation. The postoperative function was evaluated using the ankle and hindfoot score of the American Orthopaedic Foot and Ankle Society (AOFAS) and the visual analogue scale (VAS). No significant difference was found in demographics between the two groups. The corrected value of the calcaneal varus angle between the two groups is statistically significant (P articular calcaneal fractures could reduce the incidence of wound complications effectively, and the medial distraction technique is helpful for correcting the calcaneus varus deformity. © 2017 Chinese Orthopaedic Association and John Wiley & Sons Australia, Ltd.

A standards-based approach to quality improvement for HIV services at Zambia Defence Force facilities: results and lessons learned.

Science.gov (United States)

Kols, Adrienne; Kim, Young-Mi; Bazant, Eva; Necochea, Edgar; Banda, Joseph; Stender, Stacie

2015-07-01

The Zambia Defence Force adopted the Standards-Based Management and Recognition approach to improve the quality of the HIV-related services at its health facilities. This quality improvement intervention relies on comprehensive, detailed assessment tools to communicate and verify adherence to national standards of care, and to test and implement changes to improve performance. A quasi-experimental evaluation of the intervention was conducted at eight Zambia Defence Force primary health facilities (four facilities implemented the intervention and four did not). Data from three previous analyses are combined to assess the effect of Standards-Based Management and Recognition on three domains: facility readiness to provide services; observed provider performance during antiretroviral therapy (ART) and antenatal care consultations; and provider perceptions of the work environment. Facility readiness scores for ART improved on four of the eight standards at intervention sites, and one standard at comparison sites. Facility readiness scores for prevention of mother-to-child transmission (PMTCT) of HIV increased by 15 percentage points at intervention sites and 7 percentage points at comparison sites. Provider performance improved significantly at intervention sites for both ART services (from 58 to 84%; P improved at intervention sites and declined at comparison sites; differences in trends between study groups were significant for eight items. A standards-based approach to quality improvement proved effective in supporting healthcare managers and providers to deliver ART and PMTCT services in accordance with evidence-based standards in a health system suffering from staff shortages.

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.

Undergraduate nursing students' perspectives on clinical assessment at transition to practice.

Science.gov (United States)

Wu, Xi Vivien; Wang, Wenru; Pua, Lay Hoon; Heng, Doreen Gek Noi; Enskär, Karin

2015-01-01

Assessment of clinical competence requires explicitly defined standards meeting the national standards of the nursing profession. This is a complex process because of the diverse nature of nursing practice. To explore the perceptions of final-year undergraduate nursing students regarding clinical assessment at transition to practice. An exploratory qualitative approach was adopted. Twenty-four students participated in three focus group discussions. Thematic analysis was conducted. Five themes emerged: the need for a valid and reliable clinical assessment tool, the need for a flexible style of reflection and specific feedback, the dynamic clinical learning environment, students' efforts in learning and assessment, and the unclear support system for preceptors. Workload, time, resource availability, adequate preparation of preceptors, and the provision of valid and reliable clinical assessment tools were deemed to influence the quality of students' clinical learning and assessment. Nursing leadership in hospitals and educational institutions has a joint responsibility in shaping the clinical learning environment and providing clinical assessments for the students.

Regional Implementation of a Pediatric Cardiology Syncope Algorithm Using Standardized Clinical Assessment and Management Plans (SCAMPS) Methodology.

Science.gov (United States)

Paris, Yvonne; Toro-Salazar, Olga H; Gauthier, Naomi S; Rotondo, Kathleen M; Arnold, Lucy; Hamershock, Rose; Saudek, David E; Fulton, David R; Renaud, Ashley; Alexander, Mark E

2016-02-19

Pediatric syncope is common. Cardiac causes are rarely found. We describe and assess a pragmatic approach to these patients first seen by a pediatric cardiologist in the New England region, using Standardized Clinical Assessment and Management Plans (SCAMPs). Ambulatory patients aged 7 to 21 years initially seen for syncope at participating New England Congenital Cardiology Association practices over a 2.5-year period were evaluated using a SCAMP. Findings were iteratively analyzed and the care pathway was revised. The vast majority (85%) of the 1254 patients had typical syncope. A minority had exercise-related or more problematic symptoms. Guideline-defined testing identified one patient with cardiac syncope. Syncope Severity Scores correlated well between physician and patient perceived symptoms. Orthostatic vital signs were of limited use. Largely incidental findings were seen in 10% of ECGs and 11% of echocardiograms. The 10% returning for follow-up, by design, reported more significant symptoms, but did not have newly recognized cardiac disease. Iterative analysis helped refine the approach. SCAMP methodology confirmed that the vast majority of children referred to the outpatient pediatric cardiology setting had typical low-severity neurally mediated syncope that could be effectively evaluated in a single visit using minimal resources. A simple scoring system can help triage patients into treatment categories. Prespecified criteria permitted the effective diagnosis of the single patient with a clear cardiac etiology. Patients with higher syncope scores still have a very low risk of cardiac disease, but may warrant attention. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Current Methods Applied to Biomaterials - Characterization Approaches, Safety Assessment and Biological International Standards.

Science.gov (United States)

Oliveira, Justine P R; Ortiz, H Ivan Melendez; Bucio, Emilio; Alves, Patricia Terra; Lima, Mayara Ingrid Sousa; Goulart, Luiz Ricardo; Mathor, Monica B; Varca, Gustavo H C; Lugao, Ademar B

2018-04-10

Safety and biocompatibility assessment of biomaterials are themes of constant concern as advanced materials enter the market as well as products manufactured by new techniques emerge. Within this context, this review provides an up-to-date approach on current methods for the characterization and safety assessment of biomaterials and biomedical devices from a physicalchemical to a biological perspective, including a description of the alternative methods in accordance with current and established international standards. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Exploring the feasibility and synergistic value of the One Health approach in clinical research

DEFF Research Database (Denmark)

Cordoba Currea, Gloria Cristina; Sørensen, Tina Møller; Holm, Anne

2015-01-01

diagnostic pathways (i.e., 16 possiblecombinations of diagnostic tools) to gold standard in human and veterinary primary care practice in Denmark.Fifty primary care practices and 100 veterinary clinics will each consecutively include 20 human patients or 8–10dogs, respectively. Data will be collected...

Implementing PGD/PGD-A in IVF clinics: considerations for the best laboratory approach and management.

Science.gov (United States)

Capalbo, Antonio; Romanelli, Valeria; Cimadomo, Danilo; Girardi, Laura; Stoppa, Marta; Dovere, Lisa; Dell'Edera, Domenico; Ubaldi, Filippo Maria; Rienzi, Laura

2016-10-01

For an IVF clinic that wishes to implement preimplantation genetic diagnosis for monogenic diseases (PGD) and for aneuploidy testing (PGD-A), a global improvement is required through all the steps of an IVF treatment and patient care. At present, CCS (Comprehensive Chromosome Screening)-based trophectoderm (TE) biopsy has been demonstrated as a safe, accurate and reproducible approach to conduct PGD-A and possibly also PGD from the same biopsy. Key challenges in PGD/PGD-A implementation cover genetic and reproductive counselling, selection of the most efficient approach for blastocyst biopsy as well as of the best performing molecular technique to conduct CCS and monogenic disease analysis. Three different approaches for TE biopsy can be compared. However, among them, the application of TE biopsy approaches, entailing the zona opening when the expanded blastocyst stage is reached, represent the only biopsy methods suited with a totally undisturbed embryo culture strategy (time lapse-based incubation in a single media). Moreover, contemporary CCS technologies show a different spectrum of capabilities and limits that potentially impact the clinical outcomes, the management and the applicability of the PGD-A itself. In general, CCS approaches that avoid the use of whole genome amplification (WGA) can provide higher reliability of results with lower costs and turnaround time of analysis. The future perspectives are focused on the scrupulous and rigorous clinical validations of novel CCS methods based on targeted approaches that avoid the use of WGA, such as targeted next-generation sequencing technology, to further improve the throughput of analysis and the overall cost-effectiveness of PGD/PGD-A.

The emergence of international food safety standards and guidelines: understanding the current landscape through a historical approach.

Science.gov (United States)

Ramsingh, Brigit

2014-07-01

Following the Second World War, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) teamed up to construct an International Codex Alimentarius (or 'food code') which emerged in 1963. The Codex Committee on Food Hygiene (CCFH) was charged with the task of developing microbial hygiene standards, although it found itself embroiled in debate with the WHO over the nature these standards should take. The WHO was increasingly relying upon the input of biometricians and especially the International Commission on Microbial Specifications for Foods (ICMSF) which had developed statistical sampling plans for determining the microbial counts in the final end products. The CCFH, however, was initially more focused on a qualitative approach which looked at the entire food production system and developed codes of practice as well as more descriptive end-product specifications which the WHO argued were 'not scientifically correct'. Drawing upon historical archival material (correspondence and reports) from the WHO and FAO, this article examines this debate over microbial hygiene standards and suggests that there are many lessons from history which could shed light upon current debates and efforts in international food safety management systems and approaches.

The effect of personalized versus standard patient protocols for radiostereometric analysis (RSA)

DEFF Research Database (Denmark)

Muharemovic, O; Troelsen, A; Thomsen, M G

2018-01-01

INTRODUCTION: Increasing pressure in the clinic requires a more standardized approach to radiostereometric analysis (RSA) imaging. The aim of this study was to investigate whether implementation of personalized RSA patient protocols could increase image quality and decrease examination time...... imaging. Radiographers in the control group used a standard RSA protocol. RESULTS: At three months, radiographers in the case group significantly reduced (p .... No significant improvements were found in the control group at any time point. CONCLUSION: There is strong evidence that personalized RSA patient protocols have a positive effect on image quality and radiation dose savings. Implementation of personal patient protocols as a RSA standard will contribute...

Quality of Control of Clinical-Biochemical Laboratories – Serbian Case

Directory of Open Access Journals (Sweden)

Vinko Peric

2014-06-01

Full Text Available In the last 20 years in medical laboratories, numerous activities regarding quality and accreditation system were taken. Approach to this problem in European countries is different, so the task of the Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 to help the efforts to harmonize this issue. External quality control in clinical-chemical laboratories imposed the need for the implementation of quality management system. »Good laboratory practice« and its principles were adopted by nominated bodies, both international and national. In the beginning, the standard ISO 9001 was applied for certification and for accreditation EN 45001 and ISO Guide 25, which are prepared for testing and calibration laboratories. Standard ISO 17025 is the successor of the previous documents and for now it is a reference for mentioned laboratories. Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 made an amendment of the requirements for medical laboratories, which this standard describes. Standard draft ISO 15189 was adopted on February 2003 as a final version with requirements for medical laboratories.

Exploring a New Simulation Approach to Improve Clinical Reasoning Teaching and Assessment: Randomized Trial Protocol.

Science.gov (United States)

Pennaforte, Thomas; Moussa, Ahmed; Loye, Nathalie; Charlin, Bernard; Audétat, Marie-Claude

2016-02-17

Helping trainees develop appropriate clinical reasoning abilities is a challenging goal in an environment where clinical situations are marked by high levels of complexity and unpredictability. The benefit of simulation-based education to assess clinical reasoning skills has rarely been reported. More specifically, it is unclear if clinical reasoning is better acquired if the instructor's input occurs entirely after or is integrated during the scenario. Based on educational principles of the dual-process theory of clinical reasoning, a new simulation approach called simulation with iterative discussions (SID) is introduced. The instructor interrupts the flow of the scenario at three key moments of the reasoning process (data gathering, integration, and confirmation). After each stop, the scenario is continued where it was interrupted. Finally, a brief general debriefing ends the session. System-1 process of clinical reasoning is assessed by verbalization during management of the case, and System-2 during the iterative discussions without providing feedback. The aim of this study is to evaluate the effectiveness of Simulation with Iterative Discussions versus the classical approach of simulation in developing reasoning skills of General Pediatrics and Neonatal-Perinatal Medicine residents. This will be a prospective exploratory, randomized study conducted at Sainte-Justine hospital in Montreal, Qc, between January and March 2016. All post-graduate year (PGY) 1 to 6 residents will be invited to complete one SID or classical simulation 30 minutes audio video-recorded complex high-fidelity simulations covering a similar neonatology topic. Pre- and post-simulation questionnaires will be completed and a semistructured interview will be conducted after each simulation. Data analyses will use SPSS and NVivo softwares. This study is in its preliminary stages and the results are expected to be made available by April, 2016. This will be the first study to explore a new

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.

The use of standardized patients in the plastic surgery residency curriculum: teaching core competencies with objective structured clinical examinations.

Science.gov (United States)

Davis, Drew; Lee, Gordon

2011-07-01

As of 2006, the Accreditation Council for Graduate Medical Education had defined six "core competencies" of residency education: interpersonal communication skills, medical knowledge, patient care, professionalism, practice-based learning and improvement, and systems-based practice. Objective structured clinical examinations using standardized patients are becoming effective educational tools, and the authors developed a novel use of the examinations in plastic surgery residency education that assesses all six competencies. Six plastic surgery residents, two each from postgraduate years 4, 5, and 6, participated in the plastic surgery-specific objective structured clinical examination that focused on melanoma. The examination included a 30-minute videotaped encounter with a standardized patient actor and a postencounter written exercise. The residents were scored on their performance in all six core competencies by the standardized patients and faculty experts on a three-point scale (1 = novice, 2 = moderately skilled, and 3 = proficient). Resident performance was averaged for each postgraduate year, stratified according to core competency, and scored from a total of 100 percent. Residents overall scored well in interpersonal communications skills (84 percent), patient care (83 percent), professionalism (86 percent), and practice-based learning (84 percent). Scores in medical knowledge showed a positive correlation with level of training (86 percent). All residents scored comparatively lower in systems-based practice (65 percent). The residents reported unanimously that the objective structured clinical examination was realistic and educational. The objective structured clinical examination provided comprehensive and meaningful feedback and identified areas of strengths and weakness for the residents and for the teaching program. The examination is an effective assessment tool for the core competencies and a valuable adjunct to residency training.

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.

MERRF Classification: Implications for Diagnosis and Clinical Trials.

Science.gov (United States)

Finsterer, Josef; Zarrouk-Mahjoub, Sinda; Shoffner, John M

2018-03-01

Given the etiologic heterogeneity of disease classification using clinical phenomenology, we employed contemporary criteria to classify variants associated with myoclonic epilepsy with ragged-red fibers (MERRF) syndrome and to assess the strength of evidence of gene-disease associations. Standardized approaches are used to clarify the definition of MERRF, which is essential for patient diagnosis, patient classification, and clinical trial design. Systematic literature and database search with application of standardized assessment of gene-disease relationships using modified Smith criteria and of variants reported to be associated with MERRF using modified Yarham criteria. Review of available evidence supports a gene-disease association for two MT-tRNAs and for POLG. Using modified Smith criteria, definitive evidence of a MERRF gene-disease association is identified for MT-TK. Strong gene-disease evidence is present for MT-TL1 and POLG. Functional assays that directly associate variants with oxidative phosphorylation impairment were critical to mtDNA variant classification. In silico analysis was of limited utility to the assessment of individual MT-tRNA variants. With the use of contemporary classification criteria, several mtDNA variants previously reported as pathogenic or possibly pathogenic are reclassified as neutral variants. MERRF is primarily an MT-TK disease, with pathogenic variants in this gene accounting for ~90% of MERRF patients. Although MERRF is phenotypically and genotypically heterogeneous, myoclonic epilepsy is the clinical feature that distinguishes MERRF from other categories of mitochondrial disorders. Given its low frequency in mitochondrial disorders, myoclonic epilepsy is not explained simply by an impairment of cellular energetics. Although MERRF phenocopies can occur in other genes, additional data are needed to establish a MERRF disease-gene association. This approach to MERRF emphasizes standardized classification rather than clinical

Development of Abbreviated Nine-Item Forms of the Raven's Standard Progressive Matrices Test

Science.gov (United States)

Bilker, Warren B.; Hansen, John A.; Brensinger, Colleen M.; Richard, Jan; Gur, Raquel E.; Gur, Ruben C.

2012-01-01

The Raven's Standard Progressive Matrices (RSPM) is a 60-item test for measuring abstract reasoning, considered a nonverbal estimate of fluid intelligence, and often included in clinical assessment batteries and research on patients with cognitive deficits. The goal was to develop and apply a predictive model approach to reduce the number of items…

Semantic integration of medication data into the EHOP Clinical Data Warehouse.

Science.gov (United States)

Delamarre, Denis; Bouzille, Guillaume; Dalleau, Kevin; Courtel, Denis; Cuggia, Marc

2015-01-01

Reusing medication data is crucial for many medical research domains. Semantic integration of such data in clinical data warehouse (CDW) is quite challenging. Our objective was to develop a reliable and scalable method for integrating prescription data into EHOP (a French CDW). PN13/PHAST was used as the semantic interoperability standard during the ETL process, and to store the prescriptions as documents in the CDW. Theriaque was used as a drug knowledge database (DKDB), to annotate the prescription dataset with the finest granularity, and to provide semantic capabilities to the EHOP query workbench. the system was evaluated on a clinical data set. Depending on the use case, the precision ranged from 52% to 100%, Recall was always 100%. interoperability standards and DKDB, document approach, and the finest granularity approach are the key factors for successful drug data integration in CDW.

06. Facilitating Collection of Research and Quality Data in Integrative Medicine Clinical Settings: Views From Academic, Health System and Private Clinics

Science.gov (United States)

Dolor, Rowena; Victorson, David; Amoils, Steve

2013-01-01

Focus Areas: Integrative Approaches to Care The purpose of this panel discussion is to share successful efforts from a practice-based research network (PBRN) including ten integrative medicine clinics. The BraveNet PBRN includes integrative medicine clinics with academic health centers, large health systems, and a stand-alone private practice clinic. While clinical care is prioritized across all of these centers, introducing research into clinical sites oriented to providing care poses challenges that vary by clinic environment. We will highlight some of the unique issues encountered when trying to standardize data collection in sites practicing a patient-centered, whole-systems approach to healing as well as the solutions used to overcome these issues. We will present some operational solutions and data collected from the PBRN's ongoing data registry, entitled PRIMIER. The panel will engage attendees in a dialogue centering on potential for future analyses of existing results, ideas for possible upcoming studies, and creative ways to expand the PBRN data registry to include additional sites that may have expertise and interest in participating.

Translating Basic Behavioral and Social Science Research to Clinical Application: The EVOLVE Mixed Methods Approach

Science.gov (United States)

Peterson, Janey C.; Czajkowski, Susan; Charlson, Mary E.; Link, Alissa R.; Wells, Martin T.; Isen, Alice M.; Mancuso, Carol A.; Allegrante, John P.; Boutin-Foster, Carla; Ogedegbe, Gbenga; Jobe, Jared B.

2013-01-01

Objective: To describe a mixed-methods approach to develop and test a basic behavioral science-informed intervention to motivate behavior change in 3 high-risk clinical populations. Our theoretically derived intervention comprised a combination of positive affect and self-affirmation (PA/SA), which we applied to 3 clinical chronic disease…

An approach to meeting the spent fuel standard

Energy Technology Data Exchange (ETDEWEB)

Makhijani, A. [Institute for Energy and Environmental Research, Takoma Park, MD (United States)

1996-05-01

The idea of the spent fuel standard is that there should be a high surface gamma radiation to prevent theft. For purposes of preventing theft, containers should be massive, and the plutonium should be difficult to extract. This report discusses issues associated with the spent fuel standard.

An approach to meeting the spent fuel standard

International Nuclear Information System (INIS)

Makhijani, A.

1996-01-01

The idea of the spent fuel standard is that there should be a high surface gamma radiation to prevent theft. For purposes of preventing theft, containers should be massive, and the plutonium should be difficult to extract. This report discusses issues associated with the spent fuel standard

Lateral Load Capacity of Piles: A Comparative Study Between Indian Standards and Theoretical Approach

Science.gov (United States)

Jayasree, P. K.; Arun, K. V.; Oormila, R.; Sreelakshmi, H.

2018-05-01

As per Indian Standards, laterally loaded piles are usually analysed using the method adopted by IS 2911-2010 (Part 1/Section 2). But the practising engineers are of the opinion that the IS method is very conservative in design. This work aims at determining the extent to which the conventional IS design approach is conservative. This is done through a comparative study between IS approach and the theoretical model based on Vesic's equation. Bore log details for six different bridges were collected from the Kerala Public Works Department. Cast in situ fixed head piles embedded in three soil conditions both end bearing as well as friction piles were considered and analyzed separately. Piles were also modelled in STAAD.Pro software based on IS approach and the results were validated using Matlock and Reese (In Proceedings of fifth international conference on soil mechanics and foundation engineering, 1961) equation. The results were presented as the percentage variation in values of bending moment and deflection obtained by different methods. The results obtained from the mathematical model based on Vesic's equation and that obtained as per the IS approach were compared and the IS method was found to be uneconomical and conservative.

Novel electrophysiological approaches to clinical epilepsy. Diagnosis and treatment

International Nuclear Information System (INIS)

Kanazawa, Kyoko; Matsumoto, Riki; Ikeda, Akio; Kinoshita, Masako

2011-01-01

Seizure onset zone (SOZ) is currently defined by ictal epileptiform discharges, which are most commonly recorded as regional low-voltage fast waves or repetitive spikes. Interictal epileptiform discharges, on the other hand, are not specific enough for SOZ as they are recorded at zones other than the SOZ; they are also recorded from areas that do not generate the ictal pattern and from areas to which ictal discharges propagate. Besides spikes and sharp waves, a novel index of human epileptogenicity has been investigated in association with wide-band electroencephalography (EEG) analysis. We primarily noted the following during clinical neurophysiological analysis for clinical epilepsy. Recent development of digital EEG technology enabled us to record wide-band EEG in a clinical setting. Thus, high frequency (>200 Hz) and low frequency (<1 Hz) components can be reliably recorded using subdural electrodes. Direct current shift, slow shift, ripple, and fast ripple can be well delineated, and they will be potentially useful in the diagnosis and management of epileptic patients. Fiber tractography (morphological parameter) and cortico-cortical-evoked potentials with single cortical stimulation (electrophysiological parameter) elucidated cortico-cortical connections in human brain. The data thus obtained can help us understand the mechanism of seizure propagation and normal cortical functional connectivity. Non-invasive simultaneous recording of EEG and functional magnetic resonance imaging (fMRI) provided information on the roles of deep brain structures associated with scalp-recorded epileptiform discharges. Interventional neurophysiology can shed light on the non-pharmacological treatment of epilepsy. In this report, we discuss these novel electrophysiological approaches to the diagnosis and treatment of clinical epilepsy. (author)

Meta-analysis in clinical trials revisited.

Science.gov (United States)

DerSimonian, Rebecca; Laird, Nan

2015-11-01

In this paper, we revisit a 1986 article we published in this Journal, Meta-Analysis in Clinical Trials, where we introduced a random-effects model to summarize the evidence about treatment efficacy from a number of related clinical trials. Because of its simplicity and ease of implementation, our approach has been widely used (with more than 12,000 citations to date) and the "DerSimonian and Laird method" is now often referred to as the 'standard approach' or a 'popular' method for meta-analysis in medical and clinical research. The method is especially useful for providing an overall effect estimate and for characterizing the heterogeneity of effects across a series of studies. Here, we review the background that led to the original 1986 article, briefly describe the random-effects approach for meta-analysis, explore its use in various settings and trends over time and recommend a refinement to the method using a robust variance estimator for testing overall effect. We conclude with a discussion of repurposing the method for Big Data meta-analysis and Genome Wide Association Studies for studying the importance of genetic variants in complex diseases. Published by Elsevier Inc.

Query Health: standards-based, cross-platform population health surveillance.

Science.gov (United States)

Klann, Jeffrey G; Buck, Michael D; Brown, Jeffrey; Hadley, Marc; Elmore, Richard; Weber, Griffin M; Murphy, Shawn N

2014-01-01

Understanding population-level health trends is essential to effectively monitor and improve public health. The Office of the National Coordinator for Health Information Technology (ONC) Query Health initiative is a collaboration to develop a national architecture for distributed, population-level health queries across diverse clinical systems with disparate data models. Here we review Query Health activities, including a standards-based methodology, an open-source reference implementation, and three pilot projects. Query Health defined a standards-based approach for distributed population health queries, using an ontology based on the Quality Data Model and Consolidated Clinical Document Architecture, Health Quality Measures Format (HQMF) as the query language, the Query Envelope as the secure transport layer, and the Quality Reporting Document Architecture as the result language. We implemented this approach using Informatics for Integrating Biology and the Bedside (i2b2) and hQuery for data analytics and PopMedNet for access control, secure query distribution, and response. We deployed the reference implementation at three pilot sites: two public health departments (New York City and Massachusetts) and one pilot designed to support Food and Drug Administration post-market safety surveillance activities. The pilots were successful, although improved cross-platform data normalization is needed. This initiative resulted in a standards-based methodology for population health queries, a reference implementation, and revision of the HQMF standard. It also informed future directions regarding interoperability and data access for ONC's Data Access Framework initiative. Query Health was a test of the learning health system that supplied a functional methodology and reference implementation for distributed population health queries that has been validated at three sites. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under

A generalizable pre-clinical research approach for orphan disease therapy

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Beaulieu Chandree L

2012-06-01

Full Text Available Abstract With the advent of next-generation DNA sequencing, the pace of inherited orphan disease gene identification has increased dramatically, a situation that will continue for at least the next several years. At present, the numbers of such identified disease genes significantly outstrips the number of laboratories available to investigate a given disorder, an asymmetry that will only increase over time. The hope for any genetic disorder is, where possible and in addition to accurate diagnostic test formulation, the development of therapeutic approaches. To this end, we propose here the development of a strategic toolbox and preclinical research pathway for inherited orphan disease. Taking much of what has been learned from rare genetic disease research over the past two decades, we propose generalizable methods utilizing transcriptomic, system-wide chemical biology datasets combined with chemical informatics and, where possible, repurposing of FDA approved drugs for pre-clinical orphan disease therapies. It is hoped that this approach may be of utility for the broader orphan disease research community and provide funding organizations and patient advocacy groups with suggestions for the optimal path forward. In addition to enabling academic pre-clinical research, strategies such as this may also aid in seeding startup companies, as well as further engaging the pharmaceutical industry in the treatment of rare genetic disease.

Current standard treatment for pediatric glioma patients

International Nuclear Information System (INIS)

Sonoda, Yukihiko; Kumabe, Toshihiro; Saito, Ryuta; Kanamori, Masayuki; Yamashita, Yoji; Tominaga, Teiji

2012-01-01

In this paper, we selected three representative disorders among pediatric gliomas and reviewed standard treatments for these diseases. The formation of this rare disease is involved with BRAF mutation as well as cerebellar pilocytic astrocytoma. Radical resection is not recommended as initial therapy due to high morbidity. Despite its good tumor control, radiotherapy is not a standard therapy due to neuroendocrine and neurocognitive dysfunction. Several papers have reported the effectiveness of platinum-based chemotherapy, which is a useful for induction therapy. Recent progress in molecular analyses has suggested that some markers might be used for staging ependymoma. While total resection is considered to be strongly correlated with patients' survival, the majority of recurrence occurs in the primary site. Despite many clinical trials, chemotherapeutic agents were not found to be effective for this disease. Since whole brain radiation cannot prevent dissemination, local radiation is recommended for adjuvant therapy. The prognosis of this disease is still dismal, and median survival time is within 1 year. Although clinical trials have been conducted to assess the efficacy of chemotherapy prior to, concomitantly with, or after radiotherapy, an effective regimen has not yet been established. Therefore, only conventional local radiotherapy is the standard regimen for this disease. A new therapeutic approach, such as convection-enhanced drug delivery, would be required for improved outcomes in patients with this disease. (author)

The first clinical implementation of real-time image-guided adaptive radiotherapy using a standard linear accelerator.

Science.gov (United States)

Keall, Paul J; Nguyen, Doan Trang; O'Brien, Ricky; Caillet, Vincent; Hewson, Emily; Poulsen, Per Rugaard; Bromley, Regina; Bell, Linda; Eade, Thomas; Kneebone, Andrew; Martin, Jarad; Booth, Jeremy T

2018-04-01

Until now, real-time image guided adaptive radiation therapy (IGART) has been the domain of dedicated cancer radiotherapy systems. The purpose of this study was to clinically implement and investigate real-time IGART using a standard linear accelerator. We developed and implemented two real-time technologies for standard linear accelerators: (1) Kilovoltage Intrafraction Monitoring (KIM) that finds the target and (2) multileaf collimator (MLC) tracking that aligns the radiation beam to the target. Eight prostate SABR patients were treated with this real-time IGART technology. The feasibility, geometric accuracy and the dosimetric fidelity were measured. Thirty-nine out of forty fractions with real-time IGART were successful (95% confidence interval 87-100%). The geometric accuracy of the KIM system was -0.1 ± 0.4, 0.2 ± 0.2 and -0.1 ± 0.6 mm in the LR, SI and AP directions, respectively. The dose reconstruction showed that real-time IGART more closely reproduced the planned dose than that without IGART. For the largest motion fraction, with real-time IGART 100% of the CTV received the prescribed dose; without real-time IGART only 95% of the CTV would have received the prescribed dose. The clinical implementation of real-time image-guided adaptive radiotherapy on a standard linear accelerator using KIM and MLC tracking is feasible. This achievement paves the way for real-time IGART to be a mainstream treatment option. Copyright © 2018 Elsevier B.V. All rights reserved.

Isolating DNA from sexual assault cases: a comparison of standard methods with a nuclease-based approach

Science.gov (United States)

2012-01-01

Background Profiling sperm DNA present on vaginal swabs taken from rape victims often contributes to identifying and incarcerating rapists. Large amounts of the victim’s epithelial cells contaminate the sperm present on swabs, however, and complicate this process. The standard method for obtaining relatively pure sperm DNA from a vaginal swab is to digest the epithelial cells with Proteinase K in order to solubilize the victim’s DNA, and to then physically separate the soluble DNA from the intact sperm by pelleting the sperm, removing the victim’s fraction, and repeatedly washing the sperm pellet. An alternative approach that does not require washing steps is to digest with Proteinase K, pellet the sperm, remove the victim’s fraction, and then digest the residual victim’s DNA with a nuclease. Methods The nuclease approach has been commercialized in a product, the Erase Sperm Isolation Kit (PTC Labs, Columbia, MO, USA), and five crime laboratories have tested it on semen-spiked female buccal swabs in a direct comparison with their standard methods. Comparisons have also been performed on timed post-coital vaginal swabs and evidence collected from sexual assault cases. Results For the semen-spiked buccal swabs, Erase outperformed the standard methods in all five laboratories and in most cases was able to provide a clean male profile from buccal swabs spiked with only 1,500 sperm. The vaginal swabs taken after consensual sex and the evidence collected from rape victims showed a similar pattern of Erase providing superior profiles. Conclusions In all samples tested, STR profiles of the male DNA fractions obtained with Erase were as good as or better than those obtained using the standard methods. PMID:23211019

Estándares de calidad en los ensayos clínicos: ISO 9001-Buena Práctica Clínica Quality standards in clinical tests. ISO 9001: Good Clinical Practice

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Sandra Álvarez Guerra

2005-12-01

Full Text Available La calidad en los ensayos clínicos conducidos por los centros de investigación por contrato , constituye un factor de suma importancia. En la actualidad estas instituciones usan como estándar de calidad la Buena Práctica Clínica. Sin embargo, su combinación con la Norma ISO 9001:2000, estándar de calidad, internacionalmente utilizado, no se ha generalizado. Para demostrar la factibilidad que el uso conjunto de estas normas brindan a las organizaciones se decidió establecer reflexiones para demostrar cómo se complementan ambos estándares de calidad en la realización de ensayos clínicos. Para esto se revisó bibliografía actualizada en dichos temas. Se valoraron aspectos en común como: clientes, responsabilidad, tratamiento de datos generados, estadística, control de la calidad y documentos esenciales. Por medio de estos aspectos ambas normas tributan a la calidad del ensayo clínico, para una mejor protección al paciente, resultados confiables, satisfacción de los clientes, internos y externos, que garanticen la mejora continua, y establecer planes de contingencia y medidas preventivas. Se concluye que ambas normativas no están en contraposición y pueden ser utilizadas como vía capaz de garantizar excelencia en el servicio brindado.The quality of clinical tests conducted by the research centers on contract is a very important factor. Nowadays, these institutions use Good Clinical Practice as the quality standard. However, the combination of the latter with internationally used ISO 9001:2000 quality standard has not yet been generalized. In order to prove the feasibility that the joint use of these standards offers to organizations, it was decided to reflect on the way both quality standards complement each other in the performance of clinical tests. To this end, updated literature review was made. Common aspects such as clients, responsibility, treatment of data, statistics, quality control and essential documents were

The k0-based neutron activation analysis: a mono standard to standardless approach of NAA

International Nuclear Information System (INIS)

Acharya, R.; Nair, A.G.C.; Sudarshan, K.; Goswami, A.; Reddy, A.V.R.

2006-01-01

The k 0 -based neutron activation analysis (k 0 -NAA) uses neutron flux parameters, detection efficiency and nuclear constants namely k 0 and Q 0 for the determination of concentration of elements. Gold ( 197 Au) or any other element having suitable nuclear properties is used as external or internal single comparator. This article describes the principle of k 0 -NAA and standardization of method by characterization of reactor irradiation sites and calibration of efficiency of the detector and applications. The method was validated using CRMs obtained from USGS, IAEA and NIST. The applications of method includes samples like gemstones (ruby, beryl and emerald), sediments, manganese nodules and encrustations, cereals, and medicinal and edible leaves. Recently, a k-o-based internal mono standard INAA (IM-NAA) method using in-situ relative efficiency has been standardized by us for the analysis of small and large samples of different shapes and sizes. The method was applied to a new meteorite sample and large size wheat samples. Non-standard size and shape samples of nuclear cladding materials namely zircaloy 2 and 4, stainless steels (SS 316M and D9) and 1S aluminium were analysed. Standard-less analysis of these cladding materials was possible by mass balance approach since all the major and minor elements were amenable to NAA. (author)

Clinical standard of neurosurgical disorder. (9) Disturbance of consciousness

International Nuclear Information System (INIS)

Ohta, Tomio

2009-01-01

Functional diagnosis of consciousness disturbance (CD) in acute and chronic stages is becoming more important along with the progress of morphological diagnosis by CT and MRI at the stroke and brain lesion. Here described and discussed are the definition of consciousness and unconsciousness, cause and scoring of CD by various scaling and clinical significance of the scale for therapy. The author's definition for consciousness is based on patients' self identity and orientation. The above CD is essentially caused by the increased intracranial pressure, which is evaluable by imaging as the increase is derived from the herniation by tumor or edema mainly through transtentorial (uncal, hippocampal) and/or foraminal (cerebellar tonsillar) pathways. Scaling of CD stands on three factors of validity, reliability and feasibility, of which standards of JCS (Japan coma scale) and GCS (Glasgow coma scale) have been widely employed. In discussion of merit/demerit of JCS and GCS, the author et al. have proposed a new scale ECS (emergency coma scale) with 3 levels of digit code for patient's response and behavior under CD. Therapeutic outcome is greatly affected by acute CD levels evaluable by scaling, in which awakening/alertness relates with mortality, and local symptom/consciousness, with morbidity. ECS is now globally getting around. (K.T.)

MR imaging of the articular cartilage of the knee with arthroscopy as gold standard: assessment of methodological quality of clinical studies

International Nuclear Information System (INIS)

Duchateau, Florence; Berg, Bruno C. vande

2002-01-01

The purpose of this study was to assess the methodological quality of articles addressing the value of MR imaging of the knee cartilage with arthroscopy as a standard. Relevant papers were selected after Medline review (MEDLINE database search including the terms ''cartilage'' ''knee'', ''MR'' and ''arthroscopy''). Two observers reviewed independently 29 selected articles to determine how each study had met 15 individual standards that had been previously developed to assess the methodological quality of clinical investigations. The following criteria were met in variable percentage of articles including adequate definition of purpose (100%), statistical analysis (90%), avoidance of verification bias (86%), patient population description (83%), reference standard (79%), review bias (79%), study design (66%), inclusion criteria (41%) and method of analysis (41.5%), avoidance of diagnostic-review bias (24%), exclusion criteria (21%), indeterminate examination results (17%), analysis criteria (14%), interobserver reliability (14%) and intraobserver reliability (7%). The assessment of the methodological quality of clinical investigations addressing the value of MR imaging in the evaluation of the articular cartilage of the knee with arthroscopy as the standard of reference demonstrated that several standards were rarely met in the literature. Efforts should be made to rely on clearly defined lesion criteria and to determine reliability of the observations. (orig.)

Recognition and Evaluation of Clinical Section Headings in Clinical Documents Using Token-Based Formulation with Conditional Random Fields

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Hong-Jie Dai

2015-01-01

Full Text Available Electronic health record (EHR is a digital data format that collects electronic health information about an individual patient or population. To enhance the meaningful use of EHRs, information extraction techniques have been developed to recognize clinical concepts mentioned in EHRs. Nevertheless, the clinical judgment of an EHR cannot be known solely based on the recognized concepts without considering its contextual information. In order to improve the readability and accessibility of EHRs, this work developed a section heading recognition system for clinical documents. In contrast to formulating the section heading recognition task as a sentence classification problem, this work proposed a token-based formulation with the conditional random field (CRF model. A standard section heading recognition corpus was compiled by annotators with clinical experience to evaluate the performance and compare it with sentence classification and dictionary-based approaches. The results of the experiments showed that the proposed method achieved a satisfactory F-score of 0.942, which outperformed the sentence-based approach and the best dictionary-based system by 0.087 and 0.096, respectively. One important advantage of our formulation over the sentence-based approach is that it presented an integrated solution without the need to develop additional heuristics rules for isolating the headings from the surrounding section contents.

Legal standard of care: a shift from the traditional Bolam test.

Science.gov (United States)

Samanta, Ash; Samanta, Jo

2003-01-01

An essential component of an action in negligence against a doctor is proof that the doctor failed to provide the required standard of care under the circumstances. Traditionally the standard of care in law has been determined according to the Bolam test. This is based on the principle that a doctor does not breach the legal standard of care, and is therefore not negligent, if the practice is supported by a responsible body of similar professionals. The Bolam principle, however, has been perceived as being excessively reliant upon medical testimony supporting the defendant. The judgment given by the House of Lords in the recent case of Bolitho imposes a requirement that the standard proclaimed must be justified on a logical basis and must have considered the risks and benefits of competing options. The effect of Bolitho is that the court will take a more enquiring stance to test the medical evidence offered by both parties in litigation, in order to reach its own conclusions. Recent case law shows how the court has applied the Bolitho approach in determining the standard of care in cases of clinical negligence. An understanding of this approach and of the shift from the traditional Bolam test is relevant to all medical practitioners, particularly in a climate that is increasingly litigious.

A Lifecycle Approach to Brokered Data Management for Hydrologic Modeling Data Using Open Standards.

Science.gov (United States)

Blodgett, D. L.; Booth, N.; Kunicki, T.; Walker, J.

2012-12-01

The U.S. Geological Survey Center for Integrated Data Analytics has formalized an information management-architecture to facilitate hydrologic modeling and subsequent decision support throughout a project's lifecycle. The architecture is based on open standards and open source software to decrease the adoption barrier and to build on existing, community supported software. The components of this system have been developed and evaluated to support data management activities of the interagency Great Lakes Restoration Initiative, Department of Interior's Climate Science Centers and WaterSmart National Water Census. Much of the research and development of this system has been in cooperation with international interoperability experiments conducted within the Open Geospatial Consortium. Community-developed standards and software, implemented to meet the unique requirements of specific disciplines, are used as a system of interoperable, discipline specific, data types and interfaces. This approach has allowed adoption of existing software that satisfies the majority of system requirements. Four major features of the system include: 1) assistance in model parameter and forcing creation from large enterprise data sources; 2) conversion of model results and calibrated parameters to standard formats, making them available via standard web services; 3) tracking a model's processes, inputs, and outputs as a cohesive metadata record, allowing provenance tracking via reference to web services; and 4) generalized decision support tools which rely on a suite of standard data types and interfaces, rather than particular manually curated model-derived datasets. Recent progress made in data and web service standards related to sensor and/or model derived station time series, dynamic web processing, and metadata management are central to this system's function and will be presented briefly along with a functional overview of the applications that make up the system. As the separate

Chronic Fatigue Syndrome – A clinically empirical approach to its definition and study

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Papanicolaou Dimitris A

2005-12-01

Full Text Available Abstract Background The lack of standardized criteria for defining chronic fatigue syndrome (CFS has constrained research. The objective of this study was to apply the 1994 CFS criteria by standardized reproducible criteria. Methods This population-based case control study enrolled 227 adults identified from the population of Wichita with: (1 CFS (n = 58; (2 non-fatigued controls matched to CFS on sex, race, age and body mass index (n = 55; (3 persons with medically unexplained fatigue not CFS, which we term ISF (n = 59; (4 CFS accompanied by melancholic depression (n = 27; and (5 ISF plus melancholic depression (n = 28. Participants were admitted to a hospital for two days and underwent medical history and physical examination, the Diagnostic Interview Schedule, and laboratory testing to identify medical and psychiatric conditions exclusionary for CFS. Illness classification at the time of the clinical study utilized two algorithms: (1 the same criteria as in the surveillance study; (2 a standardized clinically empirical algorithm based on quantitative assessment of the major domains of CFS (impairment, fatigue, and accompanying symptoms. Results One hundred and sixty-four participants had no exclusionary conditions at the time of this study. Clinically empirical classification identified 43 subjects as CFS, 57 as ISF, and 64 as not ill. There was minimal association between the empirical classification and classification by the surveillance criteria. Subjects empirically classified as CFS had significantly worse impairment (evaluated by the SF-36, more severe fatigue (documented by the multidimensional fatigue inventory, more frequent and severe accompanying symptoms than those with ISF, who in turn had significantly worse scores than the not ill; this was not true for classification by the surveillance algorithm. Conclusion The empirical definition includes all aspects of CFS specified in the 1994 case definition and identifies persons with

Innovative approaches to clinical development and trial design

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John J Orloff

2011-01-01

Full Text Available Pharmaceutical innovation is increasingly risky, costly and at times inefficient, which has led to a decline in industry productivity. Despite the increased investment in R&D by the industry, the number of new molecular entities achieving marketing authorization is not increasing. Novel approaches to clinical development and trial design could have a key role in overcoming some of these challenges by improving efficiency and reducing attrition rates. The effectiveness of clinical development can be improved by adopting a more integrated model that increases flexibility and maximizes the use of accumulated knowledge. Central to this model of drug development are novel tools, including modelling and simulation, Bayesian methodologies, and adaptive designs, such as seamless adaptive designs and sample-size re-estimation methods. Applications of these methodologies to early- and late-stage drug development are described with some specific examples, along with advantages, challenges, and barriers to implementation. Because they are so flexible, these new trial designs require significant statistical analyses, simulations and logistical considerations to verify their operating characteristics, and therefore tend to require more time for the planning and protocol development phase. Greater awareness of the distinct advantages of innovative designs by regulators and sponsors are crucial to increasing the adoption of these modern tools.

The clinical utility of a adding lateral approach to conventional vertical approach for prone stereotactic vacuum-assisted breast biopsy

International Nuclear Information System (INIS)

Myong, Joo Hwa; Kang, Bong Joo; Yoon, Soo Kyung; Kim, Sung Hun; An, Yeong Yi

2013-01-01

The purpose of this study is to evaluate the clinical utility of adding lateral approach to conventional vertical approach for prone stereotactic vacuum-assisted breast biopsies. From April 2010 to May 2012, 130 vacuum-assisted stereotactic biopsies were attempted in 127 patients. While a vertical approach was preferred, a lateral approach was used if the vertical approach failed. The success rate of biopsies utilizing only a vertical approach was compared with that using both vertical and lateral approaches and the breast thickness for both procedures was measured and compared with that for vertical approach. In addition, pathology results were evaluated and the causes of the failed biopsies were analyzed. Of the 130 cases, 127 biopsies were performed and 3 biopsies failed. The success rate of the vertical approach was 83.8% (109/130); however, when the lateral approach was also used, the success rate increased to 97.7% (127/130) (p = 0.0004). The mean breast thickness was 2.7 ± 1 cm for the lateral approach and 4 ± 1.2 cm for the vertical approach (p < 0.0001). The histopathologic results in 76 (59.8%) of the biopsies were benign, 23 (18.1%) were high-risk lesions, and 28 (22.0%) were malignant. The causes of biopsy failure were thin breasts (n = 2) and undetected difficult lesion location (n = 1). The addition of lateral approach to conventional vertical approach in prone stereotactic vacuum-assisted breast biopsy improved the success rate of stereotactic biopsy, especially in patients with thin breasts.

Simulation with standardized patients to prepare undergraduate nursing students for mental health clinical practice: An integrative literature review.

Science.gov (United States)

Øgård-Repål, Anita; De Presno, Åsne Knutson; Fossum, Mariann

2018-04-22

To evaluate the available evidence supporting the efficacy of using simulation with standardized patients to prepare nursing students for mental health clinical practice. Integrative literature review. A systematic search of the electronic databases CINAHL (EBSCOhost), Embase, MEDLINE, PsycINFO, and SveMed+ was conducted to identify empirical studies published until November 2016. Multiple search terms were used. Original empirical studies published in English and exploring undergraduate nursing students' experiences of simulation with standardized patients as preparation for mental health nursing practice were included. A search of reference lists and gray literature was also conducted. In total, 1677 studies were retrieved; the full texts of 78 were screened by 2 of the authors, and 6 studies reminded in the review. The authors independently reviewed the studies in three stages by screening the titles, abstracts, and full texts, and the quality of the included studies was assessed in the final stage. Design-specific checklists were used for quality appraisal. The thematic synthesizing method was used to summarize the findings of the included studies. The studies used four different research designs, both qualitative and quantitative. All studies scored fairly low in the quality appraisal. The five themes identified were enhanced confidence, clinical skills, anxiety regarding the unknown, demystification, and self-awareness. The findings of this study indicate that simulation with standardized patients could decrease students' anxiety level, shatter pre-assumptions, and increase self-confidence and self-awareness before entering clinical practice in mental health. More high-quality studies with larger sample sizes are required because of the limited evidence provided by the six studies in the present review. Copyright © 2018 Elsevier Ltd. All rights reserved.

MRI/TRUS fusion software-based targeted biopsy: the new standard of care?

Science.gov (United States)

Manfredi, M; Costa Moretti, T B; Emberton, M; Villers, A; Valerio, M

2015-09-01

The advent of multiparametric MRI has made it possible to change the way in which prostate biopsy is done, allowing to direct biopsies to suspicious lesions rather than randomly. The subject of this review relates to a computer-assisted strategy, the MRI/US fusion software-based targeted biopsy, and to its performance compared to the other sampling methods. Different devices with different methods to register MR images to live TRUS are currently in use to allow software-based targeted biopsy. Main clinical indications of MRI/US fusion software-based targeted biopsy are re-biopsy in men with persistent suspicious of prostate cancer after first negative standard biopsy and the follow-up of patients under active surveillance. Some studies have compared MRI/US fusion software-based targeted versus standard biopsy. In men at risk with MRI-suspicious lesion, targeted biopsy consistently detects more men with clinically significant disease as compared to standard biopsy; some studies have also shown decreased detection of insignificant disease. Only two studies directly compared MRI/US fusion software-based targeted biopsy with MRI/US fusion visual targeted biopsy, and the diagnostic ability seems to be in favor of the software approach. To date, no study comparing software-based targeted biopsy against in-bore MRI biopsy is available. The new software-based targeted approach seems to have the characteristics to be added in the standard pathway for achieving accurate risk stratification. Once reproducibility and cost-effectiveness will be verified, the actual issue will be to determine whether MRI/TRUS fusion software-based targeted biopsy represents anadd-on test or a replacement to standard TRUS biopsy.

An intensive nurse-led, multi-interventional clinic is more successful in achieving vascular risk reduction targets than standard diabetes care.

LENUS (Irish Health Repository)

MacMahon Tone, J

2009-06-01

The aim of this research was to determine whether an intensive, nurse-led clinic could achieve recommended vascular risk reduction targets in patients with type 2 diabetes as compared to standard diabetes management.

Posterior malleolar fracture: technique and clinical ex-perience of the posterolateral approach

Directory of Open Access Journals (Sweden)

HUANG Ruo-kun

2012-04-01

Full Text Available 【Abstract】Objective: To introduce the postero-lateral surgical approach to the posterior malleolar fracture and report its clinical outcomes in 32 cases. Methods: This study consisted of 32 cases, 22 males and 10 females with the mean age of 48 years (range, 21-63 years, suffering from posterior malleolar fracture. All cases were treated with the posterolateral surgical approach to the ankle. The average follow-up period was 28 months (range, 24-35 months. The clinical outcomes of these cases were evaluated on the basis of the Olerud-Molander Ankle (OMA score and plain radiographs. Results: All cases showed radiological evidence of bony union at follow-up. The average OMA score was 82 points; 21 cases had excellent scores (90-100 points, 9 good (61-90 points, and 2 fair (31-60 points. The excellent-to-good rate was 93.8%. Although most cases did not show any wound dehiscence or necrosis, one patient had a su-perficial infection which healed after using antibiotic dress-ing and one had sural cutaneous nerve injury that under-went spontaneous remission without any treatment after three months. In addition, one presented with mild symp-toms of peroneal tendonitis that disappeared after plate removal. Conclusion: The posterolateral approach offers an effective technique for fracture reduction and fixation of large posterior malleolar fragments. Key words: Ankle injuries; Dislocations; Fracture fixation, internal

Assessing the reliability of the borderline regression method as a standard setting procedure for objective structured clinical examination

Directory of Open Access Journals (Sweden)

Sara Mortaz Hejri

2013-01-01

Full Text Available Background: One of the methods used for standard setting is the borderline regression method (BRM. This study aims to assess the reliability of BRM when the pass-fail standard in an objective structured clinical examination (OSCE was calculated by averaging the BRM standards obtained for each station separately. Materials and Methods: In nine stations of the OSCE with direct observation the examiners gave each student a checklist score and a global score. Using a linear regression model for each station, we calculated the checklist score cut-off on the regression equation for the global scale cut-off set at 2. The OSCE pass-fail standard was defined as the average of all station′s standard. To determine the reliability, the root mean square error (RMSE was calculated. The R2 coefficient and the inter-grade discrimination were calculated to assess the quality of OSCE. Results: The mean total test score was 60.78. The OSCE pass-fail standard and its RMSE were 47.37 and 0.55, respectively. The R2 coefficients ranged from 0.44 to 0.79. The inter-grade discrimination score varied greatly among stations. Conclusion: The RMSE of the standard was very small indicating that BRM is a reliable method of setting standard for OSCE, which has the advantage of providing data for quality assurance.

Traceable working standards with SI units of radiance for characterizing the measurement performance of investigational clinical NIRF imaging devices

Science.gov (United States)

Zhu, Banghe; Rasmussen, John C.; Litorja, Maritoni; Sevick-Muraca, Eva M.

2017-03-01

All medical devices for Food and Drug market approval require specifications of performance based upon International System of Units (SI) or units derived from SI for reasons of traceability. Recently, near-infrared fluorescence (NIRF) imaging devices of a variety of designs have emerged on the market and in investigational clinical studies. Yet the design of devices used in the clinical studies vary widely, suggesting variable device performance. Device performance depends upon optimal excitation of NIRF imaging agents, rejection of backscattered excitation and ambient light, and selective collection of fluorescence emanating from the fluorophore. There remains no traceable working standards with SI units of radiance to enable prediction that a given molecular imaging agent can be detected in humans by a given NIRF imaging device. Furthermore, as technologies evolve and as NIRF imaging device components change, there remains no standardized means to track device improvements over time and establish clinical performance without involving clinical trials, often costly. In this study, we deployed a methodology to calibrate luminescent radiance of a stable, solid phantom in SI units of mW/cm2/sr for characterizing the measurement performance of ICCD and IsCMOS camera based NIRF imaging devices, such as signal-to-noise ratio (SNR) and contrast. The methodology allowed determination of superior SNR of the ICCD over the IsCMOS system; comparable contrast of ICCD and IsCMOS depending upon binning strategies.

Standardizing Umbilical Cord Mesenchymal Stromal Cells for Translation to Clinical Use: Selection of GMP-Compliant Medium and a Simplified Isolation Method

Directory of Open Access Journals (Sweden)

J. Robert Smith

2016-01-01

Full Text Available Umbilical cord derived mesenchymal stromal cells (UC-MSCs are a focus for clinical translation but standardized methods for isolation and expansion are lacking. Previously we published isolation and expansion methods for UC-MSCs which presented challenges when considering good manufacturing practices (GMP for clinical translation. Here, a new and more standardized method for isolation and expansion of UC-MSCs is described. The new method eliminates dissection of blood vessels and uses a closed-vessel dissociation following enzymatic digestion which reduces contamination risk and manipulation time. The new method produced >10 times more cells per cm of UC than our previous method. When biographical variables were compared, more UC-MSCs per gram were isolated after vaginal birth compared to Caesarian-section births, an unexpected result. UC-MSCs were expanded in medium enriched with 2%, 5%, or 10% pooled human platelet lysate (HPL eliminating the xenogeneic serum components. When the HPL concentrations were compared, media supplemented with 10% HPL had the highest growth rate, smallest cells, and the most viable cells at passage. UC-MSCs grown in 10% HPL had surface marker expression typical of MSCs, high colony forming efficiency, and could undergo trilineage differentiation. The new protocol standardizes manufacturing of UC-MSCs and enables clinical translation.

From computer-assisted intervention research to clinical impact: The need for a holistic approach.

Science.gov (United States)

Ourselin, Sébastien; Emberton, Mark; Vercauteren, Tom

2016-10-01

The early days of the field of medical image computing (MIC) and computer-assisted intervention (CAI), when publishing a strong self-contained methodological algorithm was enough to produce impact, are over. As a community, we now have substantial responsibility to translate our scientific progresses into improved patient care. In the field of computer-assisted interventions, the emphasis is also shifting from the mere use of well-known established imaging modalities and position trackers to the design and combination of innovative sensing, elaborate computational models and fine-grained clinical workflow analysis to create devices with unprecedented capabilities. The barriers to translating such devices in the complex and understandably heavily regulated surgical and interventional environment can seem daunting. Whether we leave the translation task mostly to our industrial partners or welcome, as researchers, an important share of it is up to us. We argue that embracing the complexity of surgical and interventional sciences is mandatory to the evolution of the field. Being able to do so requires large-scale infrastructure and a critical mass of expertise that very few research centres have. In this paper, we emphasise the need for a holistic approach to computer-assisted interventions where clinical, scientific, engineering and regulatory expertise are combined as a means of moving towards clinical impact. To ensure that the breadth of infrastructure and expertise required for translational computer-assisted intervention research does not lead to a situation where the field advances only thanks to a handful of exceptionally large research centres, we also advocate that solutions need to be designed to lower the barriers to entry. Inspired by fields such as particle physics and astronomy, we claim that centralised very large innovation centres with state of the art technology and health technology assessment capabilities backed by core support staff and open

PubMed-supported clinical term weighting approach for improving inter-patient similarity measure in diagnosis prediction.

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Chan, Lawrence Wc; Liu, Ying; Chan, Tao; Law, Helen Kw; Wong, S C Cesar; Yeung, Andy Ph; Lo, K F; Yeung, S W; Kwok, K Y; Chan, William Yl; Lau, Thomas Yh; Shyu, Chi-Ren

2015-06-02

Similarity-based retrieval of Electronic Health Records (EHRs) from large clinical information systems provides physicians the evidence support in making diagnoses or referring examinations for the suspected cases. Clinical Terms in EHRs represent high-level conceptual information and the similarity measure established based on these terms reflects the chance of inter-patient disease co-occurrence. The assumption that clinical terms are equally relevant to a disease is unrealistic, reducing the prediction accuracy. Here we propose a term weighting approach supported by PubMed search engine to address this issue. We collected and studied 112 abdominal computed tomography imaging examination reports from four hospitals in Hong Kong. Clinical terms, which are the image findings related to hepatocellular carcinoma (HCC), were extracted from the reports. Through two systematic PubMed search methods, the generic and specific term weightings were established by estimating the conditional probabilities of clinical terms given HCC. Each report was characterized by an ontological feature vector and there were totally 6216 vector pairs. We optimized the modified direction cosine (mDC) with respect to a regularization constant embedded into the feature vector. Equal, generic and specific term weighting approaches were applied to measure the similarity of each pair and their performances for predicting inter-patient co-occurrence of HCC diagnoses were compared by using Receiver Operating Characteristics (ROC) analysis. The Areas under the curves (AUROCs) of similarity scores based on equal, generic and specific term weighting approaches were 0.735, 0.728 and 0.743 respectively (p PubMed. Our findings suggest that the optimized similarity measure with specific term weighting to EHRs can improve significantly the accuracy for predicting the inter-patient co-occurrence of diagnosis when compared with equal and generic term weighting approaches.

Validity Evidence and Scoring Guidelines for Standardized Patient Encounters and Patient Notes From a Multisite Study of Clinical Performance Examinations in Seven Medical Schools.

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Park, Yoon Soo; Hyderi, Abbas; Heine, Nancy; May, Win; Nevins, Andrew; Lee, Ming; Bordage, Georges; Yudkowsky, Rachel

2017-11-01

To examine validity evidence of local graduation competency examination scores from seven medical schools using shared cases and to provide rater training protocols and guidelines for scoring patient notes (PNs). Between May and August 2016, clinical cases were developed, shared, and administered across seven medical schools (990 students participated). Raters were calibrated using training protocols, and guidelines were developed collaboratively across sites to standardize scoring. Data included scores from standardized patient encounters for history taking, physical examination, and PNs. Descriptive statistics were used to examine scores from the different assessment components. Generalizability studies (G-studies) using variance components were conducted to estimate reliability for composite scores. Validity evidence was collected for response process (rater perception), internal structure (variance components, reliability), relations to other variables (interassessment correlations), and consequences (composite score). Student performance varied by case and task. In the PNs, justification of differential diagnosis was the most discriminating task. G-studies showed that schools accounted for less than 1% of total variance; however, for the PNs, there were differences in scores for varying cases and tasks across schools, indicating a school effect. Composite score reliability was maximized when the PN was weighted between 30% and 40%. Raters preferred using case-specific scoring guidelines with clear point-scoring systems. This multisite study presents validity evidence for PN scores based on scoring rubric and case-specific scoring guidelines that offer rigor and feedback for learners. Variability in PN scores across participating sites may signal different approaches to teaching clinical reasoning among medical schools.

A Regularized Deep Learning Approach for Clinical Risk Prediction of Acute Coronary Syndrome Using Electronic Health Records.

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Huang, Zhengxing; Dong, Wei; Duan, Huilong; Liu, Jiquan

2018-05-01

Acute coronary syndrome (ACS), as a common and severe cardiovascular disease, is a leading cause of death and the principal cause of serious long-term disability globally. Clinical risk prediction of ACS is important for early intervention and treatment. Existing ACS risk scoring models are based mainly on a small set of hand-picked risk factors and often dichotomize predictive variables to simplify the score calculation. This study develops a regularized stacked denoising autoencoder (SDAE) model to stratify clinical risks of ACS patients from a large volume of electronic health records (EHR). To capture characteristics of patients at similar risk levels, and preserve the discriminating information across different risk levels, two constraints are added on SDAE to make the reconstructed feature representations contain more risk information of patients, which contribute to a better clinical risk prediction result. We validate our approach on a real clinical dataset consisting of 3464 ACS patient samples. The performance of our approach for predicting ACS risk remains robust and reaches 0.868 and 0.73 in terms of both AUC and accuracy, respectively. The obtained results show that the proposed approach achieves a competitive performance compared to state-of-the-art models in dealing with the clinical risk prediction problem. In addition, our approach can extract informative risk factors of ACS via a reconstructive learning strategy. Some of these extracted risk factors are not only consistent with existing medical domain knowledge, but also contain suggestive hypotheses that could be validated by further investigations in the medical domain.

Ibrutinib versus previous standard of care: an adjusted comparison in patients with relapsed/refractory chronic lymphocytic leukaemia.

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Hansson, Lotta; Asklid, Anna; Diels, Joris; Eketorp-Sylvan, Sandra; Repits, Johanna; Søltoft, Frans; Jäger, Ulrich; Österborg, Anders

2017-10-01

This study explored the relative efficacy of ibrutinib versus previous standard-of-care treatments in relapsed/refractory patients with chronic lymphocytic leukaemia (CLL), using multivariate regression modelling to adjust for baseline prognostic factors. Individual patient data were collected from an observational Stockholm cohort of consecutive patients (n = 144) diagnosed with CLL between 2002 and 2013 who had received at least second-line treatment. Data were compared with results of the RESONATE clinical trial. A multivariate Cox proportional hazards regression model was used which estimated the hazard ratio (HR) of ibrutinib versus previous standard of care. The adjusted HR of ibrutinib versus the previous standard-of-care cohort was 0.15 (p ibrutinib in the RESONATE study were significantly longer than with previous standard-of-care regimens used in second or later lines in routine healthcare. The approach used, which must be interpreted with caution, compares patient-level data from a clinical trial with outcomes observed in a daily clinical practice and may complement results from randomised trials or provide preliminary wider comparative information until phase 3 data exist.

A standardized approach to study human variability in isometric thermogenesis during low-intensity physical activity

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Delphine eSarafian

2013-07-01

Full Text Available Limitations of current methods: The assessment of human variability in various compartments of daily energy expenditure (EE under standardized conditions is well defined at rest (as basal metabolic rate and thermic effect of feeding, and currently under validation for assessing the energy cost of low-intensity dynamic work. However, because physical activities of daily life consist of a combination of both dynamic and isometric work, there is also a need to develop standardized tests for assessing human variability in the energy cost of low-intensity isometric work.Experimental objectives: Development of an approach to study human variability in isometric thermogenesis by incorporating a protocol of intermittent leg press exercise of varying low-intensity isometric loads with measurements of EE by indirect calorimetry. Results: EE was measured in the seated position with the subject at rest or while intermittently pressing both legs against a press-platform at 5 low-intensity isometric loads (+5, +10, + 15, +20 and +25 kg force, each consisting of a succession of 8 cycles of press (30 s and rest (30 s. EE, integrated over each 8-min period of the intermittent leg press exercise, was found to increase linearly across the 5 isometric loads with a correlation coefficient (r > 0.9 for each individual. The slope of this EE-Load relationship, which provides the energy cost of this standardized isometric exercise expressed per kg force applied intermittently (30 s in every min, was found to show good repeatability when assessed in subjects who repeated the same experimental protocol on 3 separate days: its low intra-individual coefficient of variation (CV of ~ 10% contrasted with its much higher inter-individual CV of 35%; the latter being mass-independent but partly explained by height. Conclusion: This standardized approach to study isometric thermogenesis opens up a new avenue for research in EE phenotyping and metabolic predisposition to obesity

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

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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.

Overview of tracheal tissue engineering: clinical need drives the laboratory approach.

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Ott, Lindsey M; Weatherly, Robert A; Detamore, Michael S

2011-08-01

Breathing is a natural function that most of us do not even think about, but for those who suffer from disease or damage of the trachea, the obstruction of breathing can mean severe restrictions to quality of life or may even be fatal. Replacement and reconstruction of the trachea is one of the most difficult procedures in otolaryngology/head and neck surgery, and also one of the most vital. Previous reviews have focused primarily on clinical perspectives or instead on engineering strategies. However, the current review endeavors to bridge this gap by evaluating engineering approaches in a practical clinical context. For example, although contemporary approaches often include in vitro bioreactor pre-culture, or sub-cutaneous in vivo conditioning, the limitations they present in terms of regulatory approval, cost, additional surgery, and/or risk of infection challenge engineers to develop the next generation of biodegradable/resorbable biomaterials that can be directly implanted in situ. Essentially, the functionality of the replacement is the most important requirement. It must be the correct shape and size, achieve an airtight fit, resist collapse as it is replaced by new tissue, and be non-immunogenic. As we look to the future, there will be no one-size-fits-all solution.

Web-based objective structured clinical examination with remote standardized patients and Skype: resident experience.

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Langenau, Erik; Kachur, Elizabeth; Horber, Dot

2014-07-01

Using Skype and remote standardized patients (RSPs), investigators sought to evaluate user acceptance of a web-based objective structured clinical examination (OSCE) among resident physicians. After participating in four web-based clinical encounters addressing pain with RSPs, 59 residents from different training programs, disciplines and geographic locations completed a 52-item questionnaire regarding their experience with Skype and RSPs. Open-ended responses were solicited as well. The majority of participants (97%) agreed or strongly agreed the web-based format was convenient and a practical learning exercise, and 90% agreed or strongly agreed the format was effective in teaching communication skills. Although 93% agreed or strongly agreed they could communicate easily with RSPs using Skype, 80% preferred traditional face-to-face clinical encounters, and 58% reported technical difficulties during the encounters. Open-ended written responses supported survey results. Findings from this study expose challenges with technology and human factors, but positive experiences support the continued investigation of web-based OSCEs as a synchronous e-learning initiative for teaching and assessing doctor-patient communication. Such educational programs are valuable but unlikely to replace face-to-face encounters with patients. This web-based OSCE program provides physician learners with additional opportunity to improve doctor-patient communication. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Gamification of Clinical Routine: The Dr. Fill Approach.

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Bukowski, Mark; Kühn, Martin; Zhao, Xiaoqing; Bettermann, Ralf; Jonas, Stephan

2016-01-01

Gamification is used in clinical context in the health care education. Furthermore, it has shown great promises to improve the performance of the health care staff in their daily routine. In this work we focus on the medication sorting task, which is performed manually in hospitals. This task is very error prone and needs to be performed daily. Nevertheless, errors in the medication are crucial and lead to serious complications. In this work we present a real world gamification approach of the medication sorting task in a patient's daily pill organizer. The player of the game needs to sort the correct medication into the correct dispenser slots and is rewarded or punished in real time. At the end of the game, a score is given and the user can register in a leaderboard.

Nurse supervisors' actions in relation to their decision-making style and ethical approach to clinical supervision.

Science.gov (United States)

Berggren, Ingela; Severinsson, Elisabeth

2003-03-01

The aim of the study was to explore the decision-making style and ethical approach of nurse supervisors by focusing on their priorities and interventions in the supervision process. Clinical supervision promotes ethical awareness and behaviour in the nursing profession. A focus group comprised of four clinical nurse supervisors with considerable experience was studied using qualitative hermeneutic content analysis. The essence of the nurse supervisors' decision-making style is deliberations and priorities. The nurse supervisors' willingness, preparedness, knowledge and awareness constitute and form their way of creating a relationship. The nurse supervisors' ethical approach focused on patient situations and ethical principles. The core components of nursing supervision interventions, as demonstrated in supervision sessions, are: guilt, reconciliation, integrity, responsibility, conscience and challenge. The nurse supervisors' interventions involved sharing knowledge and values with the supervisees and recognizing them as nurses and human beings. Nurse supervisors frequently reflected upon the ethical principle of autonomy and the concept and substance of integrity. The nurse supervisors used an ethical approach that focused on caring situations in order to enhance the provision of patient care. They acted as role models, shared nursing knowledge and ethical codes, and focused on patient related situations. This type of decision-making can strengthen the supervisees' professional identity. The clinical nurse supervisors in the study were experienced and used evaluation decisions as their form of clinical decision-making activity. The findings underline the need for further research and greater knowledge in order to improve the understanding of the ethical approach to supervision.

Quality control with R an ISO standards approach

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Cano, Emilio L; Prieto Corcoba, Mariano

2015-01-01

Presenting a practitioner's guide to capabilities and best practices of quality control systems using the R programming language, this volume emphasizes accessibility and ease-of-use through detailed explanations of R code as well as standard statistical methodologies. In the interest of reaching the widest possible audience of quality-control professionals and statisticians, examples throughout are structured to simplify complex equations and data structures, and to demonstrate their applications to quality control processes, such as ISO standards. The volume balances its treatment of key aspects of quality control, statistics, and programming in R, making the text accessible to beginners and expert quality control professionals alike. Several appendices serve as useful references for ISO standards and common tasks performed while applying quality control with R.

[Poverty and Health: The Living Standard Approach as a Supplementary Concept to Measure Relative Poverty. Results from the German Socio-Economic Panel (GSOEP 2011)].

Science.gov (United States)

Pförtner, T-K

2016-06-01

A common indicator of the measurement of relative poverty is the disposable income of a household. Current research introduces the living standard approach as an alternative concept for describing and measuring relative poverty. This study compares both approaches with regard to subjective health status of the German population, and provides theoretical implications for the utilisation of the income and living standard approach in health research. Analyses are based on the German Socio-Economic Panel (GSOEP) from the year 2011 that includes 12 290 private households and 21106 survey members. Self-rated health was based on a subjective assessment of general health status. Income poverty is based on the equalised disposable income and is applied to a threshold of 60% of the median-based average income. A person will be denoted as deprived (inadequate living standard) if 3 or more out of 11 living standard items are lacking due to financial reasons. To calculate the discriminate power of both poverty indicators, descriptive analyses and stepwise logistic regression models were applied separately for men and women adjusted for age, residence, nationality, educational level, occupational status and marital status. The results of the stepwise regression revealed a stronger poverty-health relationship for the living standard indicator. After adjusting for all control variables and the respective poverty indicator, income poverty was statistically not significantly associated with a poor subjective health status among men (OR Men: 1.33; 95% CI: 1.00-1.77) and women (OR Women: 0.98; 95% CI: 0.78-1.22). In contrast, the association between deprivation and subjective health status was statistically significant for men (OR Men: 2.00; 95% CI: 1.57-2.52) and women (OR Women: 2.11; 95% CI: 1.76-2.64). The results of the present study indicate that the income and standard of living approach measure different dimensions of poverty. In comparison to the income approach, the living

Pan-Canadian Respiratory Standards Initiative for Electronic Health Records (PRESTINE: 2011 National Forum Proceedings

Directory of Open Access Journals (Sweden)

M Diane Lougheed

2012-01-01

Full Text Available In a novel knowledge translation initiative, the Government of Ontario’s Asthma Plan of Action funded the development of an Asthma Care Map to enable adherence with the Canadian Asthma Consensus Guidelines developed under the auspices of the Canadian Thoracic Society (CTS. Following its successful evaluation within the Primary Care Asthma Pilot Project, respiratory clinicians from the Asthma Research Unit, Queen’s University (Kingston, Ontario are leading an initiative to incorporate standardized Asthma Care Map data elements into electronic health records in primary care in Ontario. Acknowledging that the issue of data standards affects all respiratory conditions, and all provinces and territories, the Government of Ontario approached the CTS Respiratory Guidelines Committee. At its meeting in September 2010, the CTS Respiratory Guidelines Committee agreed that developing and standardizing respiratory data elements for electronic health records are strategically important. In follow-up to that commitment, representatives from the CTS, the Lung Association, the Government of Ontario, the National Lung Health Framework and Canada Health Infoway came together to form a planning committee. The planning committee proposed a phased approach to inform stakeholders about the issue, and engage them in the development, implementation and evaluation of a standardized dataset. An environmental scan was completed in July 2011, which identified data definitions and standards currently available for clinical variables that are likely to be included in electronic medical records in primary care for diagnosis, management and patient education related to asthma and COPD. The scan, sponsored by the Government of Ontario, includes compliance with clinical nomenclatures such as SNOMED-CT® and LOINC®. To help launch and create momentum for this initiative, a national forum was convened on October 2 and 3, 2011, in Toronto, Ontario. The forum was designed to

Recommendation of standardized health learning contents using archetypes and semantic web technologies.

Science.gov (United States)

Legaz-García, María del Carmen; Martínez-Costa, Catalina; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás

2012-01-01

Linking Electronic Healthcare Records (EHR) content to educational materials has been considered a key international recommendation to enable clinical engagement and to promote patient safety. This would suggest citizens to access reliable information available on the web and to guide them properly. In this paper, we describe an approach in that direction, based on the use of dual model EHR standards and standardized educational contents. The recommendation method will be based on the semantic coverage of the learning content repository for a particular archetype, which will be calculated by applying semantic web technologies like ontologies and semantic annotations.

Surgical management of morbidity due to lymphatic filariasis: the usefulness of a standardized international clinical classification of hydroceles.

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Capuano, G P; Capuano, C

2012-03-01

The objective of this work is to evaluate the usefulness of a standardized clinical classification of hydroceles in lymphatic filariasis endemic countries to guide their surgical management. 64 patients with hydroceles were operated in 2009-2010, in Level II hospitals (WHO classification), during two visits to Fiji, by the same mobile surgical team. The number of hydroceles treated was 83. We developed and evaluated a much needed clinical classification of hydroceles based on four criteria: Type (uni/bilateral); Side (left/right); Stage of enlargement of the scrotum rated from I to VI; Grade of burial of the penis rated from 0 to 4. It lead to the conclusion that 1) A Stage I or II hydrocele, associated with Grade 0 or 1 penis burial could be considered a "Simple Hydrocele". The surgical treatment is simple with no anticipated early complication. WHO Level II of health care structure seems adapted. 2) A Stage III or IV hydrocele associated with Grade 2, 3 or 4 penis burial could be considered a "Complicated Hydrocele". The operation is longer, more complicated and the possibility of occurrence of complications seems greater. A level III health care facility would be more adapted under the normal functioning of the health system. We conclude that a standardized clinical classification of hydroceles based on the Stage of enlargement of the scrotum and the Grade of burial of the penis appears to be a useful tool to guide the decision about the level of care and the surgical technique required. We use the same classification for penoscrotal lymphoedema. A decision tree is presented for the management of hydroceles in lymphatic filariasis endemic countries which could usefully complement the "Algorithm for management of scrotal swelling" proposed by WHO in 2002. An international classification system of hydroceles would also allow standardization and facilitate study design and comparisons of their results.

Mild obstructive sleep apnoea: clinical relevance and approaches to management.

Science.gov (United States)

McNicholas, Walter T; Bonsignore, Maria R; Lévy, Patrick; Ryan, Silke

2016-10-01

Obstructive sleep apnoea is highly prevalent in the general population worldwide, especially in its mild form. Clinical manifestations correlate poorly with disease severity measured by the apnoea-hypopnoea index (AHI), which complicates diagnosis. Full polysomnography might be more appropriate to assess suspected mild cases because limited ambulatory diagnostic systems are least accurate in mild disease. Treatment options in mild obstructive sleep apnoea include continuous positive airway pressure (CPAP) and oral appliance therapy, in addition to positional therapy and weight reduction when appropriate. The superior efficacy of CPAP in reducing AHI is offset by greater tolerance of oral appliances, especially in mild disease. Although severe obstructive sleep apnoea is associated with adverse health consequences, including cardiometabolic comorbidities, the association with mild disease is unclear, and reports differ regarding the clinical relevance of mild obstructive sleep apnoea. Improved diagnostic techniques and evidence-based approaches to management in mild obstructive sleep apnoea require further research. Copyright © 2016 Elsevier Ltd. All rights reserved.

Asian Americans and Cancer Clinical Trials: A Mixed-Methods Approach to Understanding Awareness and Experience

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Paterniti, Debora A.; Chen, Moon S.; Chiechi, Christine; Beckett, Laurel A.; Horan, Nora; Turrell, Corinne; Smith, Ligaya; Morain, Claudia; Montell, Lisa; Gonzalez, Jose Luis; Davis, Sharon; Lara, Primo N.

2006-01-01

Cancer clinical trials have been based on low accrual rates. Barriers to recruitment of minority populations affect the generalizability and impact of trial findings for those populations. The authors undertook a mixed-methods approach to understanding levels of awareness and experiences with cancer clinical trials. A survey was administered to new cancer patients and their caretakers (family, close friends, or other social support) at outpatient oncology clinics. Field observations of the trial accrual process also were conducted by employing the grounded theory approach in qualitative methods. Comparison of survey results for Asian-American respondents and non-Asian respondents indicated that Asians were less likely to have heard the term “clinical trial” and were more likely to define a clinical trial as “an experiment” or “a test procedure in a clinic” than non-Asians. Asians were more likely to have employer-based insurance and to report understanding issues related to cost reimbursement. Asians were less likely to have been involved in or to know someone in a trial and reported less willingness than white respondents to consider trial participation. Qualitative observations suggested that Asians who presented for a potential trial were interested in the availability of a novel cancer therapy but were not eligible for available trials. Multiple strategies will be necessary to enhance awareness of and experience with accrual to cancer clinical trials for Asians, including richer understanding and increased involvement of Asians in cancer clinical trials and greater attention to the location and diversity of the Asian population in structuring study centers and evaluating trial results. PMID:16247795

Bridging the gap in complementary and alternative medicine research: manualization as a means of promoting standardization and flexibility of treatment in clinical trials of acupuncture.

Science.gov (United States)

Schnyer, Rosa N; Allen, John J B

2002-10-01

An important methodological challenge encountered in acupuncture clinical research involves the design of treatment protocols that help ensure standardization and replicability while allowing for the necessary flexibility to tailor treatments to each individual. Manualization of protocols used in clinical trials of acupuncture and other traditionally-based complementary and alternative medicine (CAM) systems facilitates the systematic delivery of replicable and standardized, yet individually-tailored treatments. To facilitate high-quality CAM acupuncture research by outlining a method for the systematic design and implementation of protocols used in CAM clinical trials based on the concept of treatment manualization. A series of treatment manuals was developed to systematically articulate the Chinese medical theoretical and clinical framework for a given Western-defined illness, to increase the quality and consistency of treatment, and to standardize the technical aspects of the protocol. In all, three manuals were developed for National Institutes of Health (NIH)-funded clinical trials of acupuncture for depression, spasticity in cerebral palsy, and repetitive stress injury. In Part I, the rationale underlying these manuals and the challenges encountered in creating them are discussed, and qualitative assessments of their utility are provided. In Part II, a methodology to develop treatment manuals for use in clinical trials is detailed, and examples are given. A treatment manual provides a precise way to train and supervise practitioners, enable evaluation of conformity and competence, facilitate the training process, and increase the ability to identify the active therapeutic ingredients in clinical trials of acupuncture.

SU-E-P-22: AAPM Task Group 263 Tackling Standardization of Nomenclature for Radiation Therapy

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Matuszak, M; Feng, M [University of Michigan, Ann Arbor, MI (United States); Moran, J [Univ Michigan Medical Center, Ann Arbor, MI (United States); Xiao, Y [Thomas Jefferson University, Philadelphia, PA (United States); Mayo, C; Miller, R [Mayo Clinic, Rochester, MN (United States); Bosch, W [Washington Univ, Saint Louis, MO (United States); Popple, R [Univ Alabama Birmingham, Birmingham, AL (United States); Marks, L [UNC School of Medicine, Chapel Hill, NC (United States); Wu, Q [Duke University Medical Center, Durham, NC (United States); Molineu, A; Martel, M [UT MD Anderson Cancer Center, Houston, TX (United States); Yock, T [Massachusetts General Hospital, Boston, MA (United States); McNutt, T [Johns Hopkins University, Severna Park, MD (United States); Brown, N [Baptist Medical Center, Jacksonville, FL (United States); Purdie, T [Princess Margaret Hospital, Toronto, ON (Canada); Yorke, E [Memorial Sloan-Kettering Cancer Center, New York, NY (United States); Santanam, L [Washington University School of Medicine, St.louis, MO (United States); Gabriel, P [University of Pennsylvania, Philadelphia, PA (United States); Michalski, J [Washington University, Saint Louis, MO (United States); and others

2015-06-15

Purpose: There is growing recognition of need for increased clarity and consistency in the nomenclatures used for body and organ structures, DVH metrics, toxicity, dose and volume units, etc. Standardization has multiple benefits; e.g. facilitating data collection for clinical trials, enabling the pooling of data between institutions, making transfers (i.e. hand-offs) between centers safer, and enabling vendors to define “default” settings. Towards this goal, the American Association of Physicists in Medicine (AAPM) formed a task group (TG263) in July of 2014, operating under the Work Group on Clinical Trials to develop consensus statements. Guiding principles derived from the investigation and example nomenclatures will be presented for public feedback. Methods: We formed a multi-institutional and multi-vendor collaborative group of 39 physicists, physicians and others involved in clinical use and electronic transfer of information. Members include individuals from IROC, NRG, IHE-RO, DICOM WG-7, ASTRO and EORTC groups with overlapping interests to maximize the quality of the consensus and increase the likelihood of adoption. Surveys of group and NRG members were used to define current nomenclatures and requirements. Technical requirements of vendor systems and the proposed DICOM standards were examined. Results: There is a marked degree of inter and intra institutional variation in current approaches, resulting from inter-vendor differences in capabilities, clinic specific conceptualizations and inconsistencies. Using a consensus approach, the group defined optimal formats for the naming of targets and normal structures. A formal objective assessment of 13 existing clinically-used software packages show that all had capabilities to accommodate these recommended nomenclatures. Conclusions: A multi-stakeholder effort is making significant steps forward in developing a standard nomenclature that will work across platforms. Our current working list includes > 550

Clinical approach to diarrhea.

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Corinaldesi, Roberto; Stanghellini, Vincenzo; Barbara, Giovanni; Tomassetti, Paola; De Giorgio, Roberto

2012-10-01

Diarrhea is defined as reduced stool consistency, increased water content and number of evacuations per day. A wide array of causes and pathophysiological mechanisms underlie acute and chronic forms of diarrhea. This review focuses on the major clinical aspects which should aid clinicians to diagnose chronic diarrhea. Clinical history, physical examination and stool evaluation and the predominant stool characteristic, i.e., bloody, watery, and fatty diarrhea, may narrow the differential diagnosis. Although mainly involved in acute diarrhea, many different infectious agents, including bacteria, viruses and protozoa, can be identified in chronic bloody/inflammatory diarrhea by appropriate microbiological tests and colonoscopic biopsy analysis. Osmotic diarrhea can be the result of malabsorption or maldigestion, with a subsequent passage of fat in the stool leading to steatorrhea. Secretory diarrhea is due to an increase of fluid secretion in the small bowel lumen, a mechanism often identified in gastroenteropancreatic neuroendocrine tumors. The evaluation of the fecal osmotic gap may help to characterize whether a chronic diarrhea is osmotic or secretory. Fatty diarrhea (steatorrhea) occurs if fecal fat output exceeds the absorptive/digestive capacity of the intestine. Steatorrhea results from malabsorption or maldigestion states and tests should differentiate between these two conditions. Individualized diagnostic work ups tailored on pathophysiological and clinical features are expected to reduce costs for patients with chronic diarrhea.

Standardized EEG interpretation in patients after cardiac arrest: Correlation with other prognostic predictors.

OpenAIRE

Beuchat, I.; Solari, D.; Novy, J.; Oddo, M.; Rossetti, A.O.

2018-01-01

Standardized EEG patterns according to the American Clinical Neurophysiology Society (ACNS) ("highly malignant", "malignant" and "benign") demonstrated good correlation with outcome after cardiac arrest (CA). However, this approach relates to EEGs after target temperature management (TTM), and correlation to other recognized outcome predictors remains unknown. To investigate the relationship between categorized EEG and other outcome predictors, during and after TTM, at different temperatur...

Advanced Pre-clinical Research Approaches and Models to Studying Pediatric Anesthetic Neurotoxicity

Directory of Open Access Journals (Sweden)

Cheng eWang

2012-10-01

Full Text Available Advances in pediatric and obstetric surgery have resulted in an increase in the duration and complexity of anesthetic procedures. A great deal of concern has recently arisen regarding the safety of anesthesia in infants and children. Because of obvious limitations, it is not possible to thoroughly explore the effects of anesthetic agents on neurons in vivo in human infants or children. However, the availability of some advanced pre-clinical research approaches and models, such as imaging technology both in vitro and in vivo, stem cell and nonhuman primate experimental models, have provided potentially invaluable tools for examining the developmental effects of anesthetic agents. This review discusses the potential application of some sophisticaled research approaches, e.g., calcium imaging, in stem cell-derived in vitro models, especially human embryonic neural stem cells, along with their capacity for proliferation and their potential for differentiation, to dissect relevant mechanisms underlying the etiology of the neurotoxicity associated with developmental exposures to anesthetic agents. Also, this review attempts to discuss several advantages for using the developing rhesus monkey models (in vivo, when combined with dynamic molecular imaging approaches, in addressing critical issues related to the topic of pediatric sedation/anesthesia. These include the relationships between anesthetic-induced neurotoxicity, dose response, time-course and developmental stage at time of exposure (in vivo studies, serving to provide the most expeditious platform toward decreasing the uncertainty in extrapolating pre-clinical data to the human condition.

Person-centered approaches in medicine: clinical tasks, psychological paradigms, and postnonclassic perspective

Directory of Open Access Journals (Sweden)

Mezzich J.E.

2013-01-01

Full Text Available The article aims to demonstrate advances in methodological means suggested by Vygotsky’s cultural-historical concept in association with a theoretical model of a Person-centered diagnosis and practical use of the construct for clinical psychology and medicine. This, to a greater extent, arises from the fact that the cultural-historical concept (due to its humanistic nature and epistemological content is closely related to the person-centered integrative approach. But for all that the concept corresponds to the ideals of postnonclassical model of scientific rationality with a number of ‘key’ features. Above all it manifests its “methodological maturity” to cope with open self-developing systems, which is most essential at the modern stage of scientific knowledge.The work gives consideration to ‘defining pillars’ of Person-centered approach in modern medicine, to humanistic traditions of the Russian clinical school, and high prospects in diagnostics of such mental constructs as “subjective pattern of disease” and “social situation of personal development in disease” - within the context of person-centered integrative diagnosis.This article discusses the need for implementation a cross-cultural study of subjective pattern of disease and its correlation with a particular “social situation of personality development under disease conditions”. It aims at development and substantiation of the model of person-centered integrative approach, enhancement of its diagnostic scope and, consequently, improvement of the model of person-centered care in modern psychiatry and medicine.

Longitudinal analysis of standardized test scores of students in the Science Writing Heuristic approach

Science.gov (United States)

Chanlen, Niphon

The purpose of this study was to examine the longitudinal impacts of the Science Writing Heuristic (SWH) approach on student science achievement measured by the Iowa Test of Basic Skills (ITBS). A number of studies have reported positive impact of an inquiry-based instruction on student achievement, critical thinking skills, reasoning skills, attitude toward science, etc. So far, studies have focused on exploring how an intervention affects student achievement using teacher/researcher-generated measurement. Only a few studies have attempted to explore the long-term impacts of an intervention on student science achievement measured by standardized tests. The students' science and reading ITBS data was collected from 2000 to 2011 from a school district which had adopted the SWH approach as the main approach in science classrooms since 2002. The data consisted of 12,350 data points from 3,039 students. The multilevel model for change with discontinuity in elevation and slope technique was used to analyze changes in student science achievement growth trajectories prior and after adopting the SWH approach. The results showed that the SWH approach positively impacted students by initially raising science achievement scores. The initial impact was maintained and gradually increased when students were continuously exposed to the SWH approach. Disadvantaged students who were at risk of having low science achievement had bigger benefits from experience with the SWH approach. As a result, existing problematic achievement gaps were narrowed down. Moreover, students who started experience with the SWH approach as early as elementary school seemed to have better science achievement growth compared to students who started experiencing with the SWH approach only in high school. The results found in this study not only confirmed the positive impacts of the SWH approach on student achievement, but also demonstrated additive impacts found when students had longitudinal experiences

Aligning Animal Models of Clinical Germinal Matrix Hemorrhage, From Basic Correlation to Therapeutic Approach.

Science.gov (United States)

Lekic, Tim; Klebe, Damon; Pichon, Pilar; Brankov, Katarina; Sultan, Sally; McBride, Devin; Casel, Darlene; Al-Bayati, Alhamza; Ding, Yan; Tang, Jiping; Zhang, John H

2017-01-01

Germinal matrix hemorrhage is a leading cause of mortality and morbidity from prematurity. This brain region is vulnerable to bleeding and re-bleeding within the first 72 hours of preterm life. Cerebroventricular expansion of blood products contributes to the mechanisms of brain injury. Consequences include lifelong hydrocephalus, cerebral palsy, and intellectual disability. Unfortunately little is known about the therapeutic needs of this patient population. This review discusses the mechanisms of germinal matrix hemorrhage, the animal models utilized, and the potential therapeutic targets. Potential therapeutic approaches identified in pre-clinical investigations include corticosteroid therapy, iron chelator administration, and transforming growth factor-β pathway modulation, which all warrant further investigation. Thus, effective preclinical modeling is essential for elucidating and evaluating novel therapeutic approaches, ahead of clinical consideration. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Metabolomic approach to human brain spectroscopy identifies associations between clinical features and the frontal lobe metabolome in multiple sclerosis

Science.gov (United States)

Vingara, Lisa K.; Yu, Hui Jing; Wagshul, Mark E.; Serafin, Dana; Christodoulou, Christopher; Pelczer, István; Krupp, Lauren B.; Maletić-Savatić, Mirjana

2013-01-01

Proton magnetic resonance spectroscopy (1H-MRS) is capable of noninvasively detecting metabolic changes that occur in the brain tissue in vivo. Its clinical utility has been limited so far, however, by analytic methods that focus on independently evaluated metabolites and require prior knowledge about which metabolites to examine. Here, we applied advanced computational methodologies from the field of metabolomics, specifically partial least squares discriminant analysis and orthogonal partial least squares, to in vivo 1H-MRS from frontal lobe white matter of 27 patients with relapsing–remitting multiple sclerosis (RRMS) and 14 healthy controls. We chose RRMS, a chronic demyelinating disorder of the central nervous system, because its complex pathology and variable disease course make the need for reliable biomarkers of disease progression more pressing. We show that in vivo MRS data, when analyzed by multivariate statistical methods, can provide reliable, distinct profiles of MRS-detectable metabolites in different patient populations. Specifically, we find that brain tissue in RRMS patients deviates significantly in its metabolic profile from that of healthy controls, even though it appears normal by standard MRI techniques. We also identify, using statistical means, the metabolic signatures of certain clinical features common in RRMS, such as disability score, cognitive impairments, and response to stress. This approach to human in vivo MRS data should promote understanding of the specific metabolic changes accompanying disease pathogenesis, and could provide biomarkers of disease progression that would be useful in clinical trials. PMID:23751863

Automated Clinical Assessment from Smart home-based Behavior Data

Science.gov (United States)

Dawadi, Prafulla Nath; Cook, Diane Joyce; Schmitter-Edgecombe, Maureen

2016-01-01

Smart home technologies offer potential benefits for assisting clinicians by automating health monitoring and well-being assessment. In this paper, we examine the actual benefits of smart home-based analysis by monitoring daily behaviour in the home and predicting standard clinical assessment scores of the residents. To accomplish this goal, we propose a Clinical Assessment using Activity Behavior (CAAB) approach to model a smart home resident’s daily behavior and predict the corresponding standard clinical assessment scores. CAAB uses statistical features that describe characteristics of a resident’s daily activity performance to train machine learning algorithms that predict the clinical assessment scores. We evaluate the performance of CAAB utilizing smart home sensor data collected from 18 smart homes over two years using prediction and classification-based experiments. In the prediction-based experiments, we obtain a statistically significant correlation (r = 0.72) between CAAB-predicted and clinician-provided cognitive assessment scores and a statistically significant correlation (r = 0.45) between CAAB-predicted and clinician-provided mobility scores. Similarly, for the classification-based experiments, we find CAAB has a classification accuracy of 72% while classifying cognitive assessment scores and 76% while classifying mobility scores. These prediction and classification results suggest that it is feasible to predict standard clinical scores using smart home sensor data and learning-based data analysis. PMID:26292348

Assessment of leadership among clinical laboratories managers of teaching hospitals: Quantum leadership approach

Directory of Open Access Journals (Sweden)

H. Dargahi

2017-10-01

Full Text Available Background: Quantum leadership approach causes efficient and effective procedures among health care organizations, specially clinical laboratories. Objective: This research was aimed to determine the status of quantum leadership dimensions among all management levels of clinical laboratories of teaching hospitals of medical sciences universities in Tehran. Methods: This descriptive, analytical and cross-sectional study was induced among 180 managers of 35 clinical laboratories of Iran, Shahid Beheshti and Tehran Universities of Medical Sciences 2016. The research tool was researcher - constructed questionnaire of quantum skills, demographic details that its content and face validity and reliability were confirmed. For analysis of data, T-test and ANOVA techniques were used. Findings: Most of the studied clinical laboratories managers were male, married, with 15-20 years work experiences, 1-5 years managerial services, and minimally one training courses in clinical laboratory management. The managers had relatively desired and desired score of quantum skills and leadership respectively. Also, there was significant correlation between quantum leadership with age (P=0.01, and with management training courses (P=0.02. Conclusion: It is expected this paradigm may change the clinical laboratory management in the near future with regards to desirability of quantum leadership dimensions among clinical laboratories.

Achieving IT-supported standardized nursing documentation through participatory design

DEFF Research Database (Denmark)

Rasmussen, Stine Loft; Lyng, Karen Marie; Jensen, Sanne

2012-01-01

that support guideline-based highly structured standard documentation in a large organization with many stakeholders. Applying a participatory design (PD) approach at many organizational levels has involved the stakeholders actively in the design process. Developing a set of design principles has concurrently......In the Capital Region of Denmark a full-scale pilot project on IT-supported nursing documentation is - after running for two months at one full university hospital - showing promising results. In this paper we discuss participatory design as a method to design clinical documentation templates...

Detecting dissonance in clinical and research workflow for translational psychiatric registries.

Science.gov (United States)

Cofiel, Luciana; Bassi, Débora U; Ray, Ryan Kumar; Pietrobon, Ricardo; Brentani, Helena

2013-01-01

The interplay between the workflow for clinical tasks and research data collection is often overlooked, ultimately making it ineffective. To the best of our knowledge, no previous studies have developed standards that allow for the comparison of workflow models derived from clinical and research tasks toward the improvement of data collection processes. In this study we used the term dissonance for the occurrences where there was a discord between clinical and research workflows. We developed workflow models for a translational research study in psychiatry and the clinic where its data collection was carried out. After identifying points of dissonance between clinical and research models we derived a corresponding classification system that ultimately enabled us to re-engineer the data collection workflow. We considered (1) the number of patients approached for enrollment and (2) the number of patients enrolled in the study as indicators of efficiency in research workflow. We also recorded the number of dissonances before and after the workflow modification. We identified 22 episodes of dissonance across 6 dissonance categories: actor, communication, information, artifact, time, and space. We were able to eliminate 18 episodes of dissonance and increase the number of patients approached and enrolled in research study trough workflow modification. The classification developed in this study is useful for guiding the identification of dissonances and reveal modifications required to align the workflow of data collection and the clinical setting. The methodology described in this study can be used by researchers to standardize data collection process.

Standard approach to plant modifications

International Nuclear Information System (INIS)

Mecredy, R.C.

1988-01-01

Organizational and management approaches to the design, installation, and turnover of nuclear plant modifications have changed dramatically in the last 10 to 15 yr. In response to these changes, organizational and individual responsibilities have been defined and management systems have been established at Rochester Gas and Electric (RG and E) Corporation to ensure that high-quality plant modifications are installed in a timely manner that satisfies user needs at minimal cost

Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach

NARCIS (Netherlands)

van der Graaf, Rieke; van der Zande, Indira S. E.; den Ruijter, Hester M.; Oudijk, Martijn A.; van Delden, Johannes J. M.; Oude Rengerink, Katrien; Groenwold, Rolf H. H.

2018-01-01

Background: Since pregnant women are severely underrepresented in clinical research, many take the position that the exclusion of pregnant women from research must be justified unless there are compelling "scientific reasons" for their exclusion. However, it is questionable whether this approach

Fair inclusion of pregnant women in clinical trials : an integrated scientific and ethical approach

NARCIS (Netherlands)

van der Graaf, Rieke; van der Zande, Indira S E; den Ruijter, Hester M; Oudijk, Martijn A; van Delden, Johannes J M; Oude Rengerink, Katrien; Groenwold, Rolf H H

2018-01-01

BACKGROUND: Since pregnant women are severely underrepresented in clinical research, many take the position that the exclusion of pregnant women from research must be justified unless there are compelling "scientific reasons" for their exclusion. However, it is questionable whether this approach

Diagnosing dehydration? Blend evidence with clinical observations.

Science.gov (United States)

Armstrong, Lawrence E; Kavouras, Stavros A; Walsh, Neil P; Roberts, William O

2016-11-01

The purpose of the review is to provide recommendations to improve clinical decision-making based on the strengths and weaknesses of commonly used hydration biomarkers and clinical assessment methods. There is widespread consensus regarding treatment, but not the diagnosis of dehydration. Even though it is generally accepted that a proper clinical diagnosis of dehydration can only be made biochemically rather than relying upon clinical signs and symptoms, no gold standard biochemical hydration index exists. Other than clinical biomarkers in blood (i.e., osmolality and blood urea nitrogen/creatinine) and in urine (i.e., osmolality and specific gravity), blood pressure assessment and clinical symptoms in the eye (i.e., tear production and palpitating pressure) and the mouth (i.e., thirst and mucous wetness) can provide important information for diagnosing dehydration. We conclude that clinical observations based on a combination of history, physical examination, laboratory values, and clinician experience remain the best approach to the diagnosis of dehydration.

[Modularization by the open standard. (I)].

Science.gov (United States)

Hirano, H

2000-10-01

We are proceeding with the project called "Open LA21 Project" in the course of the clinical laboratory automation toward the 21st century. With the modular system that realizes integration, downsizing, a reasonable price, and is the future course in the clinical testing automation system as well, we aim to establish common standards among manufacturers as the only way to create user friendly market environments where the proper competition exists among the manufacturers. The common standards which are in preparation by the participating companies as "Open module system standards" are the standards which are going to be made public. They are intended to guarantee connection, compatibility of the products in conformity with the standards. In this project, we intend to realize the modular system that integrates each field, such as chemistry, hematology, coagulation/fibrinolysis, immunology, urinalysis in an early stage, and contribute positively to restructuring and upgrading the "raison d'etre" of the 21st century clinical testing.

New clinical validation method for automated sphygmomanometer: a proposal by Japan ISO-WG for sphygmomanometer standard.

Science.gov (United States)

Shirasaki, Osamu; Asou, Yosuke; Takahashi, Yukio

2007-12-01

Owing to fast or stepwise cuff deflation, or measuring at places other than the upper arm, the clinical accuracy of most recent automated sphygmomanometers (auto-BPMs) cannot be validated by one-arm simultaneous comparison, which would be the only accurate validation method based on auscultation. Two main alternative methods are provided by current standards, that is, two-arm simultaneous comparison (method 1) and one-arm sequential comparison (method 2); however, the accuracy of these validation methods might not be sufficient to compensate for the suspicious accuracy in lateral blood pressure (BP) differences (LD) and/or BP variations (BPV) between the device and reference readings. Thus, the Japan ISO-WG for sphygmomanometer standards has been studying a new method that might improve validation accuracy (method 3). The purpose of this study is to determine the appropriateness of method 3 by comparing immunity to LD and BPV with those of the current validation methods (methods 1 and 2). The validation accuracy of the above three methods was assessed in human participants [N=120, 45+/-15.3 years (mean+/-SD)]. An oscillometric automated monitor, Omron HEM-762, was used as the tested device. When compared with the others, methods 1 and 3 showed a smaller intra-individual standard deviation of device error (SD1), suggesting their higher reproducibility of validation. The SD1 by method 2 (P=0.004) significantly correlated with the participant's BP, supporting our hypothesis that the increased SD of device error by method 2 is at least partially caused by essential BPV. Method 3 showed a significantly (P=0.0044) smaller interparticipant SD of device error (SD2), suggesting its higher interparticipant consistency of validation. Among the methods of validation of the clinical accuracy of auto-BPMs, method 3, which showed the highest reproducibility and highest interparticipant consistency, can be proposed as being the most appropriate.

A new approach to the determination of air kerma using primary-standard cavity ionization chambers

International Nuclear Information System (INIS)

Burns, D T

2006-01-01

A consistent formalism is presented using Monte Carlo calculations to determine the reference air kerma from the measured energy deposition in a primary-standard cavity ionization chamber. A global approach avoiding the use of cavity ionization theory is discussed and its limitations shown in relation to the use of the recommended value for W. The role of charged-particle equilibrium is outlined and the consequent requirements placed on the calculations are detailed. Values for correction factors are presented for the BIPM air-kerma standard for 60 Co, making use of the Monte Carlo code PENELOPE, a detailed geometrical model of the BIPM 60 Co source and event-by-event electron transport. While the wall correction factor k wall = 1.0012(2) is somewhat lower than the existing value, the axial non-uniformity correction k an = 1.0027(3) is significantly higher. The use of a point source in the evaluation of k an is discussed. A comparison is made of the calculated dose ratio with the Bragg-Gray and Spencer-Attix stopping-power ratios, the results indicating a preference for the Bragg-Gray approach in this particular case. A change to the recommended value for W of up to 2 parts in 10 3 is discussed. The uncertainties arising from the geometrical models, the use of phase-space files, the radiation transport algorithms and the underlying radiation interaction coefficients are estimated

Clinical approach to dyslipidaemia

African Journals Online (AJOL)

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