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

PubMed

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.

StaR Child Health: improving global standards for child health research.

PubMed

Offringa, Martin; Needham, Allison C; Chan, Winnie W Y

2013-11-01

Standards for Research (StaR) in Child Health, founded in 2009, addresses the current scarcity of and deficiencies in pediatric clinical trials. StaR Child Health brings together leading international experts devoted to developing practical, evidence-based standards to enrich the reliability and relevance of pediatric clinical research. Through a systematic "knowledge to action" plan, StaR Child Health creates opportunities to improve the evidence base for child health across the world. To date, six standards have been published and four more are under development. It is now time to use these standards. Improving the design, conduct and reporting of pediatric clinical trials will ultimately advance the quality of health care provided to children across the globe. Crown Copyright © 2013. All rights reserved.

The Arden Syntax standard for clinical decision support: experiences and directions.

PubMed

Samwald, Matthias; Fehre, Karsten; de Bruin, Jeroen; Adlassnig, Klaus-Peter

2012-08-01

Arden Syntax is a widely recognized standard for representing clinical and scientific knowledge in an executable format. It has a history that reaches back until 1989 and is currently maintained by the Health Level 7 (HL7) organization. We created a production-ready development environment, compiler, rule engine and application server for Arden Syntax. Over the course of several years, we have applied this Arden - Syntax - based CDS system in a wide variety of clinical problem domains, such as hepatitis serology interpretation, monitoring of nosocomial infections or the prediction of metastatic events in melanoma patients. We found the Arden Syntax standard to be very suitable for the practical implementation of CDS systems. Among the advantages of Arden Syntax are its status as an actively developed HL7 standard, the readability of the syntax, and various syntactic features such as flexible list handling. A major challenge we encountered was the technical integration of our CDS systems in existing, heterogeneous health information systems. To address this issue, we are currently working on incorporating the HL7 standard GELLO, which provides a standardized interface and query language for accessing data in health information systems. We hope that these planned extensions of the Arden Syntax might eventually help in realizing the vision of a global, interoperable and shared library of clinical decision support knowledge. Copyright © 2012 Elsevier Inc. All rights reserved.

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

PubMed

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.

FDA: Evidentiary Standards for Drug Development and Approval

PubMed Central

Katz, Russell

2004-01-01

Summary: The United States Food and Drug Administration is charged with approving drug treatments that have been shown to be safe and effective. Relevant statutes and regulations provide a legal framework for establishing safety and effectiveness that is sufficiently flexible to ensure that appropriate scientific data are collected for specific treatments targeted to particular diseases. Nonetheless, all clinical trials proposed to establish effectiveness must incorporate common elements in order for the appropriate legal and scientific standards of drug approval to be met. This article will discuss the relevant laws and regulations pertaining to the current effectiveness standard and will discuss the most important clinical trial design elements currently considered acceptable for applications for treatments of neurologic and psychiatric illness. PMID:15717032

Pediatric and Adolescent Gynecology in Europe: Clinical Services, Standards of Care, and Training.

PubMed

Richmond, Anna; Priyanka, Sweta; Mahmood, Tahir; MacDougall, Jane; Wood, Paul

2016-06-01

To identify current clinical services and training available across Europe within pediatric and adolescent gynecology (PAG) and establish the extent to which PAG services meet current European Board and College of Obstetrics and Gynecology (EBCOG) standards. Quantitative and qualitative questionnaire. European countries that are members of the EBCOG and the European Association of Pediatric and Adolescent Gynecology. Thirty-six countries that were approached beginning in September 2013; data were obtained from 27 countries. Questionnaires with 28 stems were sent to clinical leaders in 36 European countries. National society, national standards, legislation for female genital mutilation, protocols for transition to adult services, human papilloma virus vaccination programs, sex and contraception education, safeguarding, clinical leads for PAG, delivery of PAG services, and training available for PAG. Of 36 countries, 27 responded. Seventy-seven percent had a national PAG society but only 44% had national standards in PAG. There was agreement that PAG cases should be multidisciplinary but not all have clinical networks in place to facilitate this. Human papilloma virus programs are available in some European countries and not all have legislation against female genital mutilation. A significant proportion of cases continue to be seen in adult gynecology clinics as opposed to designated PAG clinics with only 41% with processes to transfer patients into adult care. In this article we provide a framework to explore areas for improvement within PAG services and training across Europe. The EBCOG standards of care are not being adhered to in many countries because processes and clinical networks are not in place to facilitate them. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

A Clinician-Centered Evaluation of the Usability of AHLTA and Automated Clinical Practice Guidelines at TAMC

DTIC Science & Technology

2011-03-31

evidence based medicine into clinical practice. It will decrease costs and enable multiple stakeholders to work in an open content/source environment to exchange clinical content, develop and test technology and explore processes in applied CDS. Design: Comparative study between the KMR infrastructure and capabilities developed as an open source, vendor agnostic solution for aCPG execution within AHLTA and the current DoD/MHS standard evaluating: H1: An open source, open standard KMR and Clinical Decision Support Engine can enable organizations to share domain

Blood Cholesterol Measurement in Clinical Laboratories in the United States. Current Status. A Report from the Laboratory Standardization Panel of the National Cholesterol Education Program.

ERIC Educational Resources Information Center

National Heart, Lung, and Blood Inst. (DHHS/NIH), Bethesda, MD.

Precise and accurate cholesterol measurements are required to identify and treat individuals with high blood cholesterol levels. However, the current state of reliability of blood cholesterol measurements suggests that considerable inaccuracy in cholesterol testing exists. This report describes the Laboratory Standardization Panel findings on the…

[Research strategies in standard decoction of medicinal slices].

PubMed

Chen, Shi-Lin; Liu, An; Li, Qi; Toru, Sugita; Zhu, Guang-Wei; Sun, Yi; Dai, Yun-Tao; Zhang, Jun; Zhang, Tie-Jun; Takehisa, Tomoda; Liu, Chang-Xiao

2016-04-01

This paper discusses the research situation of the standard decoction of medicinal slices at home and abroad. Combined with the experimental data, the author proposes that the standard decoction of medicinal slices is made of single herb using standard process which should be guided by the theory of traditional Chinese medicine, based on clinical practice and referred to modern extraction method with a standard process. And the author also proposes the principles of establishing the specification of process parameters and quality standards and established the basis of drug efficacy material and biological reference. As a standard material and standard system, the standard decoction of medicinal slices can provide standards for clinical medication, standardize the use of the new type of medicinal slices especially for dispensing granules, which were widely used in clinical. It can ensure the accuracy of drugs and consistency of dose, and to solve current supervision difficulties. Moreover the study of standard decoction of medicinal slices will provide the research on dispensing granules, traditional Chinese medicine prescription standard decoction and couplet medicines standard decoction a useful reference. Copyright© by the Chinese Pharmaceutical Association.

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

PubMed

Jones, W Schuyler; Krucoff, Mitchell W; Morales, Pablo; Wilgus, Rebecca W; Heath, Anne H; Williams, Mary F; Tcheng, James E; Marinac-Dabic, J Danica; Malone, Misti L; Reed, Terrie L; Fukaya, Rie; Lookstein, Robert A; Handa, Nobuhiro; Aronow, Herbert D; Bertges, Daniel J; Jaff, Michael R; Tsai, Thomas T; Smale, Joshua A; Zaugg, Margo J; Thatcher, Robert J; Cronenwett, Jack L

2018-02-01

The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators. Copyright © 2017 Society for Vascular Surgery. All rights reserved.

LabRS: A Rosetta stone for retrospective standardization of clinical laboratory test results.

PubMed

Hauser, Ronald George; Quine, Douglas B; Ryder, Alex

2018-02-01

Clinical laboratories in the United States do not have an explicit result standard to report the 7 billion laboratory tests results they produce each year. The absence of standardized test results creates inefficiencies and ambiguities for secondary data users. We developed and tested a tool to standardize the results of laboratory tests in a large, multicenter clinical data warehouse. Laboratory records, each of which consisted of a laboratory result and a test identifier, from 27 diverse facilities were captured from 2000 through 2015. Each record underwent a standardization process to convert the original result into a format amenable to secondary data analysis. The standardization process included the correction of typos, normalization of categorical results, separation of inequalities from numbers, and conversion of numbers represented by words (eg, "million") to numerals. Quality control included expert review. We obtained 1.266 × 109 laboratory records and standardized 1.252 × 109 records (98.9%). Of the unique unstandardized records (78.887 × 103), most appeared <5 times (96%, eg, typos), did not have a test identifier (47%), or belonged to an esoteric test with <100 results (2%). Overall, these 3 reasons accounted for nearly all unstandardized results (98%). Current results suggest that the tool is both scalable and generalizable among diverse clinical laboratories. Based on observed trends, the tool will require ongoing maintenance to stay current with new tests and result formats. Future work to develop and implement an explicit standard for test results would reduce the need to retrospectively standardize test results. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Practical Considerations for Clinical PET/MR Imaging.

PubMed

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.

Practical Considerations for Clinical PET/MR Imaging.

PubMed

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

2017-05-01

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 © 2016 Elsevier Inc. All rights reserved.

A review of the International Atomic Energy Agency (IAEA) international standards for tissue banks.

PubMed

Morales Pedraza, Jorge; Lobo Gajiwala, Astrid; Martinez Pardo, María Esther

2012-03-01

The IAEA International Standards for Tissue Banks published in 2003 were based on the Standards then currently in use in the USA and the European Union, among others, and reflect the best practices associated with the operation of a tissue bank. They cover legal, ethical and regulatory controls as well as requirements and procedures from donor selection and tissue retrieval to processing and distribution of finished tissue for clinical use. The application of these standards allows tissue banks to operate with the current good tissue practice, thereby providing grafts of high quality that satisfy the national and international demand for safe and biologically useful grafts. The objective of this article is to review the IAEA Standards and recommend new topics that could improve the current version.

Clinical Supervision for School Psychologists: National Practices, Trends and Future Implications.

ERIC Educational Resources Information Center

Fischetti, Barbara A.; Crespi, Tony D.

1999-01-01

Survey assesses current practice trends in the clinical supervision of school psychologists. Data indicates that while ten percent of practicing school psychologists were participating in individual and/or group clinical supervision nationwide, respondents were receiving less supervision than recommended by APA or NASP professional standards.…

Patient-derived Xenograft (PDX) Models In Basic and Translational Breast Cancer Research

PubMed Central

Dobrolecki, Lacey E.; Airhart, Susie D.; Alferez, Denis G.; Aparicio, Samuel; Behbod, Fariba; Bentires-Alj, Mohamed; Brisken, Cathrin; Bult, Carol J.; Cai, Shirong; Clarke, Robert B.; Dowst, Heidi; Ellis, Matthew J.; Gonzalez-Suarez, Eva; Iggo, Richard D.; Kabos, Peter; Li, Shunqiang; Lindeman, Geoffrey J.; Marangoni, Elisabetta; McCoy, Aaron; Meric-Bernstam, Funda; Piwnica-Worms, Helen; Poupon, Marie-France; Reis-Filho, Jorge; Sartorius, Carol A.; Scabia, Valentina; Sflomos, George; Tu, Yizheng; Vaillant, François; Visvader, Jane E.; Welm, Alana; Wicha, Max S.

2017-01-01

Patient-derived xenograft (PDX) models of a growing spectrum of cancers are rapidly supplanting long-established traditional cell lines as preferred models for conducting basic and translational pre-clinical research. In breast cancer, to complement the now curated collection of approximately 45 long-established human breast cancer cell lines, a newly formed consortium of academic laboratories, currently from Europe, Australia, and North America, herein summarizes data on over 500 stably transplantable PDX models representing all three clinical subtypes of breast cancer (ER+, HER2+, and “Triple-negative” (TNBC)). Many of these models are well-characterized with respect to genomic, transcriptomic, and proteomic features, metastatic behavior, and treatment response to a variety of standard-of-care and experimental therapeutics. These stably transplantable PDX lines are generally available for dissemination to laboratories conducting translational research, and contact information for each collection is provided. This review summarizes current experiences related to PDX generation across participating groups, efforts to develop data standards for annotation and dissemination of patient clinical information that does not compromise patient privacy, efforts to develop complementary data standards for annotation of PDX characteristics and biology, and progress toward “credentialing” of PDX models as surrogates to represent individual patients for use in pre-clinical and co-clinical translational research. In addition, this review highlights important unresolved questions, as well as current limitations, that have hampered more efficient generation of PDX lines and more rapid adoption of PDX use in translational breast cancer research. PMID:28025748

Comparing Parent-Child Interactions in the Clinic and at Home: An Exploration of the Validity of Clinical Behavior Observations Using Sequential Analysis

ERIC Educational Resources Information Center

Shriver, Mark D.; Frerichs, Lynae J.; Williams, Melissa; Lancaster, Blake M.

2013-01-01

Direct observation is often considered the "gold standard" for assessing the function, frequency, and intensity of problem behavior. Currently, the literature investigating the construct validity of direct observation conducted in the clinic setting reveals conflicting results. Previous studies on the construct validity of clinic-based…

Standardizing terms for clinical pharmacogenetic test results: consensus terms from the Clinical Pharmacogenetics Implementation Consortium (CPIC).

PubMed

Caudle, Kelly E; Dunnenberger, Henry M; Freimuth, Robert R; Peterson, Josh F; Burlison, Jonathan D; Whirl-Carrillo, Michelle; Scott, Stuart A; Rehm, Heidi L; Williams, Marc S; Klein, Teri E; Relling, Mary V; Hoffman, James M

2017-02-01

Reporting and sharing pharmacogenetic test results across clinical laboratories and electronic health records is a crucial step toward the implementation of clinical pharmacogenetics, but allele function and phenotype terms are not standardized. Our goal was to develop terms that can be broadly applied to characterize pharmacogenetic allele function and inferred phenotypes. Terms currently used by genetic testing laboratories and in the literature were identified. The Clinical Pharmacogenetics Implementation Consortium (CPIC) used the Delphi method to obtain a consensus and agree on uniform terms among pharmacogenetic experts. Experts with diverse involvement in at least one area of pharmacogenetics (clinicians, researchers, genetic testing laboratorians, pharmacogenetics implementers, and clinical informaticians; n = 58) participated. After completion of five surveys, a consensus (>70%) was reached with 90% of experts agreeing to the final sets of pharmacogenetic terms. The proposed standardized pharmacogenetic terms will improve the understanding and interpretation of pharmacogenetic tests and reduce confusion by maintaining consistent nomenclature. These standard terms can also facilitate pharmacogenetic data sharing across diverse electronic health care record systems with clinical decision support.Genet Med 19 2, 215-223.

12. Children and Adolescents: Standards of Medical Care in Diabetes-2018.

PubMed

2018-01-01

The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" includes ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC. © 2017 by the American Diabetes Association.

Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

PubMed Central

Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

2011-01-01

Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project. PMID:26069574

Laboratory Diagnosis and Characterization of Fungal Disease in Patients with Cystic Fibrosis (CF): A Survey of Current UK Practice in a Cohort of Clinical Microbiology Laboratories.

PubMed

Boyle, Maeve; Moore, John E; Whitehouse, Joanna L; Bilton, Diana; Downey, Damian G

2018-03-02

There is much uncertainty as to how fungal disease is diagnosed and characterized in patients with cystic fibrosis (CF). A 19-question anonymous electronic questionnaire was developed and distributed to ascertain current practice in clinical microbiology laboratories providing a fungal laboratory service to CF centres in the UK. Analyses of responses identified the following: (1) current UK laboratory practice, in general, follows the current guidelines, but the scope and diversity of what is currently being delivered by laboratories far exceeds what is detailed in the guidelines; (2) there is a lack of standardization of fungal tests amongst laboratories, outside of the current guidelines; (3) both the UK CF Trust Laboratory Standards for Processing Microbiological Samples from People with Cystic Fibrosis and the US Cumulative Techniques and Procedures in Clinical Microbiology (Cumitech) Guidelines 43 Cystic Fibrosis Microbiology need to be updated to reflect both new methodological innovations, as well as better knowledge of fungal disease pathophysiology in CF; (4) there is a need for clinical medicine to decide upon a stratification strategy for the provision of new fungal assays that will add value to the physician in the optimal management of CF patients; (5) there is also a need to rationale what assays should be performed at local laboratory level and those which are best served at National Mycology Reference Laboratory level; and (6) further research is required in developing laboratory assays, which will help ascertain the clinical importance of 'old' fungal pathogens, as well as 'emerging' fungal pathogens.

Reporting of interventions and "standard of care" control arms in pediatric clinical trials: a quantitative analysis.

PubMed

Yu, Ashley M; Balasubramanaiam, Bannuya; Offringa, Martin; Kelly, Lauren E

2018-06-13

In pediatric medicine, the usual treatment received by children ("standard of care") varies across centers. Evaluations of new treatments often compare to the existing "standard of care" to determine if a treatment is more effective, has a better safety profile, or costs less. The objective of our study was to evaluate intervention and "standard of care" control arms reported in published pediatric clinical trials. Pediatric clinical trials, published in 2014, reporting the use of a "standard of care" control arm were included. Duplicate assessment of reporting completeness was done using the 12-item TIDieR (Template for Intervention Description and Replication) checklist for both the "standard of care" control arms and intervention arms within the same published study. Following screening, 214 pediatric trials in diverse therapeutic areas were included. Several different terms were used to describe "standard of care." There was a significant difference between the mean reported TIDieR checklist items of "standard of care" control arms (5.81 (SD 2.13) and intervention arms (8.45 (SD 1.39, p < 0.0001). Reporting of intervention and "standard of care" control arms in pediatric clinical trials should be improved as current "standard of care" reporting deficiencies limit reproducibility of research and may ultimately contribute to research waste.

Nucleic acid tests for the detection of alpha human papillomaviruses.

PubMed

Poljak, Mario; Cuzick, Jack; Kocjan, Boštjan J; Iftner, Thomas; Dillner, Joakim; Arbyn, Marc

2012-11-20

Testing for high-risk types of alpha human papillomaviruses (HPV) is an invaluable part of clinical guidelines for cervical carcinoma screening, management and treatment. In this comprehensive inventory of commercial tests for detection of alpha-HPV, we identified at least 125 distinct HPV tests and at least 84 variants of the original tests. However, only a small subset of HPV tests has documented clinical performance for any of the standard HPV testing indications. For more than 75% of HPV tests currently on the market, no single publication in peer-reviewed literature can be identified. HPV tests that have not been validated and lack proof of reliability, reproducibility and accuracy should not be used in clinical management. Once incorporated in the lab, it is essential that the whole procedure of HPV testing is subject to continuous and rigorous quality assurance to avoid sub-optimal, potentially harmful practices. Manufacturers of HPV tests are urged to put more effort into evaluating their current and future products analytically, using international standards, and for clinical applications, using clinically validated endpoints. To assist with analytical validation, the World Health Organization is developing international standards for HPV types other than HPV16 and HPV18 and is planning development of external quality control panels specifically designed to be used for performance evaluation of current and future HPV tests. There is a need for more competitively priced HPV tests, especially for resource-poor countries, and uniform test validation criteria based on international standards should enable issuing more competitive and fair tender notices for purchasing. Automation systems allowing large-scale testing, as well as further increases in clinical performance, are the main needs in the further improvement of HPV tests. This article forms part of a special supplement entitled "Comprehensive Control of HPV Infections and Related Diseases" Vaccine Volume 30, Supplement 5, 2012. Copyright © 2012 Elsevier Ltd. All rights reserved.

Chlamydial partner notification in the British Association for Sexual Health and HIV (BASHH) 2011 UK national audit against the BASHH Medical Foundation for AIDS and Sexual Health Sexually Transmitted Infections Management Standards.

PubMed

McClean, H; Carne, C A; Sullivan, A K; Radcliffe, K W; Ahmed-Jushuf, I

2012-10-01

This paper reports on chlamydial partner notification (PN) performance in the 2011 BASHH national audit against the British Association for Sexual Health and HIV (BASHH) Medical Foundation for AIDS Sexual Health (MedFASH) Sexually Transmitted Infection Management Standards (STIMS). There was wide regional variation in level 3 clinic PN performance against the current standard of index case-reported chlamydial PN, with 43% (regional range 0-80%) of clinics outside London meeting the ≥0.6 contacts seen per index standard, and 85% of clinics (regional range 82-88%) in London meeting the ≥0.4 standard. For level 2 clinics, 39% (regional range 0-100%) of clinics outside London met the ≥0.6 standard, and 43% (regional range 40-50%) of clinics in London met the ≥0.4 standard. Performance for health-care worker (HCW)-verified contact attendance is also reported. New standards for each of these performance measures are proposed for all level 3 clinics: ≥0.6 contacts seen per index case based on index case report, and ≥0.4 contacts seen per index case based on HCW verification, both within four weeks of the first partner notification interview. The results are discussed with regard to the importance of adoption of standards by commissioners of services, relevance to national quality agendas, and the need for development of a national system of PN quality assurance measurement and reporting.

The role of MRI in musculoskeletal practice: a clinical perspective

PubMed Central

Dean Deyle, Gail

2011-01-01

This clinical perspective presents an overview of current and potential uses for magnetic resonance imaging (MRI) in musculoskeletal practice. Clinical practice guidelines and current evidence for improved outcomes will help providers determine the situations when an MRI is indicated. The advanced competency standard of examination used by physical therapists will be helpful to prevent overuse of musculoskeletal imaging, reduce diagnostic errors, and provide the appropriate clinical context to pathology revealed on MRI. Physical therapists are diagnostically accurate and appropriately conservative in their use of MRI consistent with evidence-based principles of diagnosis and screening. PMID:22851878

The use of psychometrists in clinical neuropsychology: history, current status, and future directions.

PubMed

Malek-Ahmadi, Michael; Erickson, Tom; Puente, Antonio E; Pliskin, Neil; Rock, Rachel

2012-01-01

In recent years, the National Academy of Neuropsychology and other professional neuropsychological organizations have published a number of articles and position papers regarding the use, education, and training of psychometrists ("technicians"). Although these documents provide guidelines for the suggested qualifications and training procedures of psychometrists, none make any mention of the need for a standardized credentialing process, which is commonly required of technicians in similar fields, especially in medical settings. Given the recent changes in current procedural Terminology codes used to bill for neuropsychological services and the interpretation of legislation disallowing the use of psychometrists in New York, the need for a standard credential for psychometrists is apparent. This article will review the history and current use of psychometrists in clinical neuropsychology and highlight the need and rationale for the credentialing of psychometrists.

Current Trends in Nursing Informatics: Results of an International Survey.

PubMed

Peltonen, Laura-Maria; Alhuwail, Dari; Ali, Samira; Badger, Martha K; Eler, Gabrielle Jacklin; Georgsson, Mattias; Islam, Tasneem; Jeon, Eunjoo; Jung, Hyunggu; Kuo, Chiu-Hsiang; Lewis, Adrienne; Pruinelli, Lisiane; Ronquillo, Charlene; Sarmiento, Raymond Francis; Sommer, Janine; Tayaben, Jude L; Topaz, Maxim

2016-01-01

Nursing informatics (NI) can help provide effective and safe healthcare. This study aimed to describe current research trends in NI. In the summer 2015, the IMIA-NI Students Working Group created and distributed an online international survey of the current NI trends. A total of 402 responses were submitted from 44 countries. We identified a top five NI research areas: standardized terminologies, mobile health, clinical decision support, patient safety and big data research. NI research funding was considered to be difficult to acquire by the respondents. Overall, current NI research on education, clinical practice, administration and theory is still scarce, with theory being the least common. Further research is needed to explain the impact of these trends and the needs from clinical practice.

Guidelines for obstetrical practice in Japan: Japan Society of Obstetrics and Gynecology (JSOG) and Japan Association of Obstetricians and Gynecologists (JAOG) 2014 edition.

PubMed

Minakami, Hisanori; Maeda, Tsugio; Fujii, Tomoyuki; Hamada, Hiromi; Iitsuka, Yoshinori; Itakura, Atsuo; Itoh, Hiroaki; Iwashita, Mitsutoshi; Kanagawa, Takeshi; Kanai, Makoto; Kasuga, Yoshio; Kawabata, Masakiyo; Kobayashi, Kosuke; Kotani, Tomomi; Kudo, Yoshiki; Makino, Yasuo; Matsubara, Shigeki; Matsuda, Hideo; Miura, Kiyonori; Murakoshi, Takeshi; Murotsuki, Jun; Ohkuchi, Akihide; Ohno, Yasumasa; Ohshiba, Yoko; Satoh, Shoji; Sekizawa, Akihiko; Sugiura, Mayumi; Suzuki, Shunji; Takahashi, Tsuneo; Tsukahara, Yuki; Unno, Nobuya; Yoshikawa, Hiroyuki

2014-06-01

The 'Clinical Guidelines for Obstetrical Practice, 2011 edition' were revised and published as a 2014 edition (in Japanese) in April 2014 by the Japan Society of Obstetrics and Gynecology and the Japan Association of Obstetricians and Gynecologists. The aims of this publication include the determination of current standard care practices for pregnant women in Japan, the widespread use of standard care practices, the enhancement of safety in obstetrical practice, the reduction of burdens associated with medico-legal and medico-economical problems, and a better understanding between pregnant women and maternity-service providers. The number of Clinical Questions and Answers items increased from 87 in the 2011 edition to 104 in the 2014 edition. The Japanese 2014 version included a Discussion, a List of References, and some Tables and Figures following the Answers to the 104 Clinical Questions; these additional sections covered common problems and questions encountered in obstetrical practice, helping Japanese readers to achieve a comprehensive understanding. Each answer with a recommendation level of A, B or C was prepared based principally on 'evidence' or a consensus among Japanese obstetricians in situations where 'evidence' was weak or lacking. Answers with a recommendation level of A or B represent current standard care practices in Japan. All 104 Clinical Questions and Answers items, with the omission of the Discussion, List of References, and Tables and Figures, are presented herein to promote a better understanding among English readers of the current standard care practices for pregnant women in Japan. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

Addiction Competencies in the 2009 CACREP Clinical Mental Health Counseling Program Standards

ERIC Educational Resources Information Center

Lee, Tiffany K.; Craig, Stephen E.; Fetherson, Bianca T. L.; Simpson, C. Dennis

2013-01-01

The Council for Accreditation of Counseling and Related Educational Programs developed addiction competencies for clinical mental health counseling students. This article highlights these competencies, provides an overview of current addiction training, and describes methods to integrate addiction education into curricula.

Standardizing terms for clinical pharmacogenetic test results: consensus terms from the Clinical Pharmacogenetics Implementation Consortium (CPIC)

PubMed Central

Caudle, Kelly E.; Dunnenberger, Henry M.; Freimuth, Robert R.; Peterson, Josh F.; Burlison, Jonathan D.; Whirl-Carrillo, Michelle; Scott, Stuart A.; Rehm, Heidi L.; Williams, Marc S.; Klein, Teri E.; Relling, Mary V.; Hoffman, James M.

2017-01-01

Introduction: Reporting and sharing pharmacogenetic test results across clinical laboratories and electronic health records is a crucial step toward the implementation of clinical pharmacogenetics, but allele function and phenotype terms are not standardized. Our goal was to develop terms that can be broadly applied to characterize pharmacogenetic allele function and inferred phenotypes. Materials and methods: Terms currently used by genetic testing laboratories and in the literature were identified. The Clinical Pharmacogenetics Implementation Consortium (CPIC) used the Delphi method to obtain a consensus and agree on uniform terms among pharmacogenetic experts. Results: Experts with diverse involvement in at least one area of pharmacogenetics (clinicians, researchers, genetic testing laboratorians, pharmacogenetics implementers, and clinical informaticians; n = 58) participated. After completion of five surveys, a consensus (>70%) was reached with 90% of experts agreeing to the final sets of pharmacogenetic terms. Discussion: The proposed standardized pharmacogenetic terms will improve the understanding and interpretation of pharmacogenetic tests and reduce confusion by maintaining consistent nomenclature. These standard terms can also facilitate pharmacogenetic data sharing across diverse electronic health care record systems with clinical decision support. Genet Med 19 2, 215–223. PMID:27441996

A SOA-Based Platform to Support Clinical Data Sharing.

PubMed

Gazzarata, R; Giannini, B; Giacomini, M

2017-01-01

The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the "Interoperable" Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes) vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the "Interoperable" Tier, the current solution actually covers the "Connected" Tier, due to local hospital policy restrictions.

A SOA-Based Platform to Support Clinical Data Sharing

PubMed

Gazzarata, R; Giannini, B; Giacomini, M

2017-01-01

The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the “Interoperable” Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes) vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the “Interoperable” Tier, the current solution actually covers the “Connected” Tier, due to local hospital policy restrictions. © 2017 R. Gazzarata et al.

A SOA-Based Platform to Support Clinical Data Sharing

PubMed Central

Gazzarata, R.; Giannini, B.

2017-01-01

The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the “Interoperable” Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes) vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the “Interoperable” Tier, the current solution actually covers the “Connected” Tier, due to local hospital policy restrictions. PMID:29065576

MREIT experiments with 200 µA injected currents: a feasibility study using two reconstruction algorithms, SMM and harmonic B(Z).

PubMed

Arpinar, V E; Hamamura, M J; Degirmenci, E; Muftuler, L T

2012-07-07

Magnetic resonance electrical impedance tomography (MREIT) is a technique that produces images of conductivity in tissues and phantoms. In this technique, electrical currents are applied to an object and the resulting magnetic flux density is measured using magnetic resonance imaging (MRI) and the conductivity distribution is reconstructed using these MRI data. Currently, the technique is used in research environments, primarily studying phantoms and animals. In order to translate MREIT to clinical applications, strict safety standards need to be established, especially for safe current limits. However, there are currently no standards for safe current limits specific to MREIT. Until such standards are established, human MREIT applications need to conform to existing electrical safety standards in medical instrumentation, such as IEC601. This protocol limits patient auxiliary currents to 100 µA for low frequencies. However, published MREIT studies have utilized currents 10-400 times larger than this limit, bringing into question whether the clinical applications of MREIT are attainable under current standards. In this study, we investigated the feasibility of MREIT to accurately reconstruct the relative conductivity of a simple agarose phantom using 200 µA total injected current and tested the performance of two MREIT reconstruction algorithms. These reconstruction algorithms used are the iterative sensitivity matrix method (SMM) by Ider and Birgul (1998 Elektrik 6 215-25) with Tikhonov regularization and the harmonic B(Z) proposed by Oh et al (2003 Magn. Reason. Med. 50 875-8). The reconstruction techniques were tested at both 200 µA and 5 mA injected currents to investigate their noise sensitivity at low and high current conditions. It should be noted that 200 µA total injected current into a cylindrical phantom generates only 14.7 µA current in imaging slice. Similarly, 5 mA total injected current results in 367 µA in imaging slice. Total acquisition time for 200 µA and 5 mA experiments was about 1 h and 8.5 min, respectively. The results demonstrate that conductivity imaging is possible at low currents using the suggested imaging parameters and reconstructing the images using iterative SMM with Tikhonov regularization, which appears to be more tolerant to noisy data than harmonic B(Z).

Current Standards of Care and Long Term Outcomes for Thalassemia and Sickle Cell Disease.

PubMed

Chonat, Satheesh; Quinn, Charles T

2017-01-01

Thalassemia and sickle cell disease (SCD) are disorders of hemoglobin that affect millions of people worldwide. The carrier states for these diseases arose as common, balanced polymorphisms during human history because they afforded protection against severe forms of malaria. These complex, multisystem diseases are reviewed here with a focus on current standards of clinical management and recent research findings. The importance of a comprehensive, multidisciplinary and lifelong system of care is also emphasized.

Development of Best practices document for Peptide Standards | Office of Cancer Clinical Proteomics Research

Cancer.gov

The Assay Development Working Group (ADWG) of the CPTAC Program is currently drafting a document to propose best practices for generation, quantification, storage, and handling of peptide standards used for mass spectrometry-based assays, as well as interpretation of quantitative proteomic data based on peptide standards. The ADWG is seeking input from commercial entities that provide peptide standards for mass spectrometry-based assays or that perform amino acid analysis.

Instruments to identify prescription medication misuse, abuse, and related events in clinical trials: an ACTTION systematic review

PubMed Central

Smith, Shannon M.; Paillard, Florence; McKeown, Andrew; Burke, Laurie B.; Edwards, Robert R.; Katz, Nathaniel P.; Papadopoulos, Elektra J.; Rappaport, Bob A.; Slagle, Ashley; Strain, Eric C.; Wasan, Ajay D.; Turk, Dennis C.; Dworkin, Robert H.

2017-01-01

Measurement of inappropriate medication use events (e.g., abuse, misuse) in clinical trials is important in characterizing a medication’s abuse potential. However, no “gold standard” assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (i.e., content validity, cross-sectional reliability and construct validity, longitudinal construct validity, ability to detect change, and responder definitions) of instruments assessing inappropriate use of opioid and non-opioid prescription medications to identify any that meet U.S. and European regulatory agencies’ rigorous standards for outcome measures in clinical trials. Sixteen published instruments were identified, most of which were not designed for the selected concept of interest and context of use. For this reason, many instruments were found to lack adequate content validity (or documentation of content validity) to evaluate current inappropriate medication use events; for example, evaluating inappropriate use across the lifespan rather than current use, including items that did not directly assess inappropriate use (e.g., questions about anger), or failing to capture information pertinent to inappropriate use events (e.g., intention, route of administration). In addition, the psychometric data across all instruments were generally limited in scope. A further limitation is the heterogeneous, non-standardized use of inappropriate medication use terminology. These observations suggest that available instruments are not well suited for assessing current inappropriate medication use within the specific context of clinical trials. Further effort is needed to develop reliable and valid instruments to measure current inappropriate medication use events in clinical trials. PMID:25660826

The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems.

PubMed

Weininger, Sandy; Jaffe, Michael B; Goldman, Julian M

2017-01-01

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development.

The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems

PubMed Central

Weininger, Sandy; Jaffe, Michael B.; Goldman, Julian M

2016-01-01

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account this systems perspective. In this article we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups; some which focus on safety and effectiveness, and others that focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development. PMID:27584685

A Clinical Approach to Antioxidant Therapy: Hypertonic Fluid Resuscitation Trial

DTIC Science & Technology

2003-06-01

5 2. Experimental Section...limited forward surgical care and delayed evacuation.[9] 1.1.1 Current Fluid Resuscitation Standard of Care By virtue of clinical experience , low cost...bleeding, thereby potentially increasing mortality. Indeed, evidence from experimental animal studies suggests that small-volume hypotensive

[Current overview of cartilage regeneration procedures].

PubMed

Schenker, H; Wild, M; Rath, B; Tingart, M; Driessen, A; Quack, V; Betsch, M

2017-11-01

Cartilage is an avascular, alymphatic and non-innervated tissue with limited intrinsic repair potential. The high prevalence of cartilage defects and their tremendous clinical importance are a challenge for all treating physicians. This article provides the reader with an overview about current cartilage treatment options and their clinical outcome. Microfracture is still considered the gold standard in the treatment of small cartilage lesions. Small osteochondral defects can be effectively treated with the autologous osteochondral transplantation system. Larger cartilage defects are successfully treated by autologous membrane-induced chondrogenesis (AMIC) or by membrane-assisted autologous chondrocyte implantation (MACI). Despite limitations of current cartilage repair strategies, such procedures can result in short- and mid-term clinical improvement of the patients. Further developments and clinical studies are necessary to improve the long-term outcome following cartilage repair.

Posturography and locomotor tests of dynamic balance after long-duration spaceflight.

PubMed

Cohen, Helen S; Kimball, Kay T; Mulavara, Ajitkumar P; Bloomberg, Jacob J; Paloski, William H

2012-01-01

The currently approved objective clinical measure of standing balance in astronauts after space flight is the Sensory Organization Test battery of computerized dynamic posturography. No tests of walking balance are currently approved for standard clinical testing of astronauts. This study determined the sensitivity and specificity of standing and walking balance tests for astronauts before and after long-duration space flight. Astronauts were tested on an obstacle avoidance test known as the Functional Mobility Test (FMT) and on the Sensory Organization Test using sway-referenced support surface motion with eyes closed (SOT 5) before and six months after (n=15) space flight on the International Space Station. They were tested two to seven days after landing. Scores on SOT tests decreased and scores on FMT increased significantly from pre- to post-flight. In other words, post-flight scores were worse than pre-flight scores. SOT and FMT scores were not significantly related. ROC analyses indicated supra-clinical cut-points for SOT 5 and for FMT. The standard clinical cut-point for SOT 5 had low sensitivity to post-flight astronauts. Higher cut-points increased sensitivity to post-flight astronauts but decreased specificity to pre-flight astronauts. Using an FMT cut-point that was moderately highly sensitive and highly specific plus SOT 5 at the standard clinical cut-point was no more sensitive than SOT 5, alone. FMT plus SOT 5 at higher cut-points was more specific and more sensitive. The total correctly classified was highest for FMT, alone, and for FMT plus SOT 5 at the highest cut-point. These findings indicate that standard clinical comparisons are not useful for identifying problems. Testing both standing and walking balance will be more likely to identify balance deficits.

Quality standards for bone conduction implants.

PubMed

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

2015-01-01

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

The Computerized Medical Record as a Tool for Clinical Governance in Australian Primary Care

PubMed Central

Phillips, Christine; Hall, Sally; Travaglia, Joanne

2013-01-01

Background Computerized medical records (CMR) are used in most Australian general practices. Although CMRs have the capacity to amalgamate and provide data to the clinician about their standard of care, there is little research on the way in which they may be used to support clinical governance: the process of ensuring quality and accountability that incorporates the obligation that patients are treated according to best evidence. Objective The objective of this study was to explore the capability, capacity, and acceptability of CMRs to support clinical governance. Methods We conducted a realist review of the role of seven CMR systems in implementing clinical governance, developing a four-level maturity model for the CMR. We took Australian primary care as the context, CMR to be the mechanism, and looked at outcomes for individual patients, localities, and for the population in terms of known evidence-based surrogates or true outcome measures. Results The lack of standardization of CMRs makes national and international benchmarking challenging. The use of the CMR was largely at level two of our maturity model, indicating a relatively simple system in which most of the process takes place outside of the CMR, and which has little capacity to support benchmarking, practice comparisons, and population-level activities. Although national standards for coding and projects for record access are proposed, they are not operationalized. Conclusions The current CMR systems can support clinical governance activities; however, unless the standardization and data quality issues are addressed, it will not be possible for current systems to work at higher levels. PMID:23939340

Current Standards of Care and Long Term Outcomes for Thalassemia and Sickle Cell Disease

PubMed Central

Chonat, Satheesh

2017-01-01

Thalassemia and sickle cell disease (SCD) are disorders of hemoglobin that affect millions of people worldwide. The carrier states for these diseases arose as common, balanced polymorphisms during human history because they afforded protection against severe forms of malaria. These complex, multisystem diseases are reviewed here with a focus on current standards of clinical management and recent research findings. The importance of a comprehensive, multidisciplinary and lifelong system of care is also emphasized. PMID:29127677

Development of clinical practice guidelines.

PubMed

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

2014-01-01

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

A summative, Objective, Structured, Clinical Examination in ENT used to assess postgraduate doctors after one year of ENT training, as part of the Diploma of Otorhinolaryngology, Head and Neck Surgery.

PubMed

Drake-Lee, A B; Skinner, D; Hawthorne, M; Clarke, R

2009-10-01

'High stakes' postgraduate medical examinations should conform to current educational standards. In the UK and Ireland, national assessments in surgery are devised and managed through the examination structure of the Royal Colleges of Surgeons. Their efforts are not reported in the medical education literature. In the current paper, we aim to clarify this process. To replace the clinical section of the Diploma of Otorhinolaryngology with an Objective, Structured, Clinical Examination, and to set the level of the assessment at one year of postgraduate training in the specialty. After 'blueprinting' against the whole curriculum, an Objective, Structured, Clinical Examination comprising 25 stations was divided into six clinical stations and 19 other stations exploring written case histories, instruments, test results, written communication skills and interpretation skills. The pass mark was set using a modified borderline method and other methods, and statistical analysis of the results was performed. The results of nine examinations between May 2004 and May 2008 are presented. The pass mark varied between 68 and 82 per cent. Internal consistency was good, with a Cronbach's alpha value of 0.99 for all examinations and split-half statistics varying from 0.96 to 0.99. Different standard settings gave similar pass marks. We have developed a summative, Objective, Structured, Clinical Examination for doctors training in otorhinolaryngology, reported herein. The objectives and standards of setting a high quality assessment were met.

High efficiency video coding for ultrasound video communication in m-health systems.

PubMed

Panayides, A; Antoniou, Z; Pattichis, M S; Pattichis, C S; Constantinides, A G

2012-01-01

Emerging high efficiency video compression methods and wider availability of wireless network infrastructure will significantly advance existing m-health applications. For medical video communications, the emerging video compression and network standards support low-delay and high-resolution video transmission, at the clinically acquired resolution and frame rates. Such advances are expected to further promote the adoption of m-health systems for remote diagnosis and emergency incidents in daily clinical practice. This paper compares the performance of the emerging high efficiency video coding (HEVC) standard to the current state-of-the-art H.264/AVC standard. The experimental evaluation, based on five atherosclerotic plaque ultrasound videos encoded at QCIF, CIF, and 4CIF resolutions demonstrates that 50% reductions in bitrate requirements is possible for equivalent clinical quality.

Mapping patient pathways and estimating resource use for point of care versus standard testing and treatment of chlamydia and gonorrhoea in genitourinary medicine clinics in the UK.

PubMed

Adams, Elisabeth J; Ehrlich, Alice; Turner, Katherine M E; Shah, Kunj; Macleod, John; Goldenberg, Simon; Meray, Robin K; Pearce, Vikki; Horner, Patrick

2014-07-23

We aimed to explore patient pathways using a chlamydia/gonorrhoea point-of-care (POC) nucleic acid amplification test (NAAT), and estimate and compare the costs of the proposed POC pathways with the current pathways using standard laboratory-based NAAT testing. Workshops were conducted with healthcare professionals at four sexual health clinics representing diverse models of care in the UK. They mapped out current pathways that used chlamydia/gonorrhoea tests, and constructed new pathways using a POC NAAT. Healthcare professionals' time was assessed in each pathway. The proposed POC pathways were then priced using a model built in Microsoft Excel, and compared to previously published costs for pathways using standard NAAT-based testing in an off-site laboratory. Pathways using a POC NAAT for asymptomatic and symptomatic patients and chlamydia/gonorrhoea-only tests were shorter and less expensive than most of the current pathways. Notably, we estimate that POC testing as part of a sexual health screen for symptomatic patients, or as stand-alone chlamydia/gonorrhoea testing, could reduce costs per patient by as much as £16 or £6, respectively. In both cases, healthcare professionals' time would be reduced by approximately 10 min per patient. POC testing for chlamydia/gonorrhoea in a clinical setting may reduce costs and clinician time, and may lead to more appropriate and quicker care for patients. Further study is warranted on how to best implement POC testing in clinics, and on the broader clinical and cost implications of this technology. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Current progress in patient-specific modeling

PubMed Central

2010-01-01

We present a survey of recent advancements in the emerging field of patient-specific modeling (PSM). Researchers in this field are currently simulating a wide variety of tissue and organ dynamics to address challenges in various clinical domains. The majority of this research employs three-dimensional, image-based modeling techniques. Recent PSM publications mostly represent feasibility or preliminary validation studies on modeling technologies, and these systems will require further clinical validation and usability testing before they can become a standard of care. We anticipate that with further testing and research, PSM-derived technologies will eventually become valuable, versatile clinical tools. PMID:19955236

Defining the Path Forward: Guidance for Laboratory Medicine Guidelines

PubMed Central

Jones, Patricia M.; Chin, Alex C.; Christenson, Robert H.

2015-01-01

The National Academy of Clinical Biochemistry (NACB) has developed consensus-based guidelines for the laboratory evaluation and monitoring of patients with specified disorders for two decades. In 1997, the NACB recognized the need to standardize the process of guideline development and promulgated its first Standard Operating Procedure (SOP) for this purpose. In 2010, the American Association of Clinical Chemistry (AACC) and NACB created the Evidence-Based Laboratory Medicine Committee (EBLMC). Among other roles, this group was given responsibility to provide oversight of clinical practice guideline development in accordance with SOP guidance and using currently accepted good practices. In 2011, the U.S. Institute of Medicine (IOM) published two reports of relevance: ‘Clinical Practice Guidelines We Can Trust’ and ‘Finding What Works in Health Care – Standards for Systematic Reviews.’ These reports were created as part of a response to a legislative mandate from the U.S. Congress requesting that steps be taken to implement recommendations from lOM’s report on ‘Knowing What Works in Health Care’ (2008). The latest revision of the laboratory medicine practice guidelines (LMPG) SOP was in part driven by these reports. NACB continues to develop LMPGs at a rate of roughly one per year through standard processes detailed in its 2014 revision of the SOP. This article describes the NACB and EBLMC experience in developing LMPGs with a focus on the evolution and use of the latest SOP. AACC and NACB have established a solid track record in collaboratively working with many clinical societies and professional organizations on clinical practice guideline development. Presently, three LMPG’s are in various stages of development and all with the collaboration of other clinical/professional groups. The practices and tools being used for current LMPGs in progress are also highlighted in the context of the challenges that presently exist for effective clinical practice guideline development in the U.S. PMID:27683491

Hacked off.

PubMed

1988-05-28

The new book on occupational health for nurses called Nurses At Risk written by [illegible word] Salvage, former Nursing Standard journalist and Rosemary Rogers, currently our Clinical News Editor, received widespread press coverage.

Strategic Deployment of Clinical Models.

PubMed

Goossen, William

2016-01-01

The selection, implementation, and certification of electronic health records (EHR) could benefit from the required use of one of the established clinical model approaches. For the lifelong record of data about individuals, issues arise about the permanence and preservation of data during or even beyond a lifetime. Current EHR do not fully adhere to pertinent standards for clinical data, where it is known for some 20 plus years that standardization of health data is a cornerstone for patient safety, interoperability, data retrieval for various purposes and the lifelong preservation of such data. This paper briefly introduces the issues and gives a brief recommendation for future work in this area.

Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

PubMed

Freeman, Kathleen P; Bauer, Natali; Jensen, Asger L; Thoresen, Stein

2006-06-01

A trend in human and veterinary medical laboratory management is to achieve accreditation based on international standards. The International Organization for Standardization (ISO) 15189 standard is the first developed especially for accreditation of medical laboratories, and emphasizes the laboratory-client interface. European veterinary laboratories seeking to train candidates for the certification examination of the European College of Veterinary Clinical Pathology (ECVCP) require approval by the ECVCP Laboratory Standards Committee, which bases its evaluation in part on adherence to quality systems described in the ISO 15189 standards. The purpose of this article was to introduce the latest ISO quality standard and describe its application to veterinary laboratories in Europe, specifically as pertains to accreditation of laboratories involved in training veterinary clinical pathologists. Between 2003 and 2006, the Laboratory Standards Committee reviewed 12 applications from laboratories (3 commercial and 9 university) involved in training veterinary clinical pathologists. Applicants were asked to provide a description of the facilities for training and testing, current methodology and technology, health and safety policy, quality assurance policy (including internal quality control and participation in an external quality assurance program), written standard operating procedures (SOPs) and policies, a description of the laboratory information system, and personnel and training. Also during this time period multiple informal and formal discussions among ECVCP diplomates took place as to current practices and perceived areas of concern with regard to laboratory accreditation requirements. Areas in which improvement most often was needed in veterinary laboratories applying for ECVCP accreditation were the written quality plan, defined quality requirements for the tests performed, written SOPs and policies, training records, ongoing audits and competency assessments, and processes for identifying and addressing opportunities for improvement. Recommendations were developed for a stepwise approach towards achieving ISO 15189 standards, including 3 levels of quality components. The ISO 15189 standard provides a sound framework for veterinary laboratories aspiring to meet international quality standards.

Clinical decision support systems for improving diagnostic accuracy and achieving precision medicine.

PubMed

Castaneda, Christian; Nalley, Kip; Mannion, Ciaran; Bhattacharyya, Pritish; Blake, Patrick; Pecora, Andrew; Goy, Andre; Suh, K Stephen

2015-01-01

As research laboratories and clinics collaborate to achieve precision medicine, both communities are required to understand mandated electronic health/medical record (EHR/EMR) initiatives that will be fully implemented in all clinics in the United States by 2015. Stakeholders will need to evaluate current record keeping practices and optimize and standardize methodologies to capture nearly all information in digital format. Collaborative efforts from academic and industry sectors are crucial to achieving higher efficacy in patient care while minimizing costs. Currently existing digitized data and information are present in multiple formats and are largely unstructured. In the absence of a universally accepted management system, departments and institutions continue to generate silos of information. As a result, invaluable and newly discovered knowledge is difficult to access. To accelerate biomedical research and reduce healthcare costs, clinical and bioinformatics systems must employ common data elements to create structured annotation forms enabling laboratories and clinics to capture sharable data in real time. Conversion of these datasets to knowable information should be a routine institutionalized process. New scientific knowledge and clinical discoveries can be shared via integrated knowledge environments defined by flexible data models and extensive use of standards, ontologies, vocabularies, and thesauri. In the clinical setting, aggregated knowledge must be displayed in user-friendly formats so that physicians, non-technical laboratory personnel, nurses, data/research coordinators, and end-users can enter data, access information, and understand the output. The effort to connect astronomical numbers of data points, including '-omics'-based molecular data, individual genome sequences, experimental data, patient clinical phenotypes, and follow-up data is a monumental task. Roadblocks to this vision of integration and interoperability include ethical, legal, and logistical concerns. Ensuring data security and protection of patient rights while simultaneously facilitating standardization is paramount to maintaining public support. The capabilities of supercomputing need to be applied strategically. A standardized, methodological implementation must be applied to developed artificial intelligence systems with the ability to integrate data and information into clinically relevant knowledge. Ultimately, the integration of bioinformatics and clinical data in a clinical decision support system promises precision medicine and cost effective and personalized patient care.

Islet cell transplant: Update on current clinical trials

PubMed Central

Schuetz, Christian; Markmann, James F.

2016-01-01

In the last 15 years clinical islet transplantation has made the leap from experimental procedure to standard of care for a highly selective group of patients. Due to a risk-benefit calculation involving the required systemic immunosuppression the procedure is only considered in patients with type 1 diabetes, complicated by severe hypoglycemia or end stage renal disease. In this review we summarize current outcomes of the procedure and take a look at ongoing and future improvements and refinements of beta cell therapy. PMID:28451515

Advances in diagnostic and treatment modalities for intracranial tumors.

PubMed

Dickinson, P J

2014-01-01

Intracranial neoplasia is a common clinical condition in domestic companion animals, particularly in dogs. Application of advances in standard diagnostic and therapeutic modalities together with a broad interest in the development of novel translational therapeutic strategies in dogs has resulted in clinically relevant improvements in outcome for many canine patients. This review highlights the status of current diagnostic and therapeutic approaches to intracranial neoplasia and areas of novel treatment currently in development. Copyright © 2014 by the American College of Veterinary Internal Medicine.

Tighter accuracy standards within point-of-care blood glucose monitoring: how six commonly used systems compare.

PubMed

Robinson, Charlotte S; Sharp, Patrick

2012-05-01

Blood glucose monitoring systems (BGMS) are used in the hospital environment to manage blood glucose levels in patients at the bedside. The International Organization for Standardization (ISO) 15197:2003 standard is currently used by regulatory bodies as a minimum requirement for the performance of BGMS, specific to self-testing. There are calls for the tightening of accuracy requirements and implementation of a standard specifically for point-of-care (POC) BGMS. The accuracy of six commonly used BGMS was assessed in a clinical setting, with 108 patients' finger stick capillary samples. Using the accuracy criteria from the existing standard and a range of tightened accuracy criteria, system performance was compared. Other contributors to system performance have been measured, including hematocrit sensitivity and meter error rates encountered in the clinical setting. Five of the six BGMS evaluated met current accuracy criteria within the ISO 15197 standard. Only the Optium Xceed system had >95% of all readings within a tightened criteria of ±12.5% from the reference at glucose levels ≥72 mg/dl (4 mmol/liter) and ±9 mg/dl (0.5 mmol/liter) at glucose levels <72 mg/dl (4 mmol/liter). The Nova StatStrip Xpress had the greatest number of error messages observed; Optium Xceed the least. OneTouch Ultra2, Nova StatStrip Xpress, Accu-Chek Performa, and Contour TS products were all significantly influenced by blood hematocrit levels. From evidence obtained during this clinical evaluation, the Optium Xceed system is most likely to meet future anticipated accuracy standards for POC BGMS. In this clinical study, the results demonstrated the Optium Xceed product to have the highest level of accuracy, to have the lowest occurrence of error messages, and to be least influenced by blood hematocrit levels. © 2012 Diabetes Technology Society.

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

PubMed

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.

Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

PubMed Central

Miller, Melissa B.; Hindler, Janet

2015-01-01

The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use “equivalent QC” (EQC) or the Clinical and Laboratory Standards Institute (CLSI) standards alone for quality control of their microbiology systems. The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown. PMID:26447112

Changes to pediatric clerkships' nighttime structure after introduction of the 2011 ACGME resident duty hour standards.

PubMed

Smith, Andrew; Stevenson, Adam

2014-01-01

To report changes in pediatric clerkship nighttime clinical structures before and after implementation of the 2011 Accreditation Council for Graduate Medical Education (ACGME) resident duty hour standards. As part of the 2011 Council on Medical Student Education in Pediatrics (COMSEP) member annual survey, we surveyed leaders of pediatric undergraduate medical education on their medical school's current nighttime clinical structure, changes in nighttime structure between 2010 and 2011, and their school's student duty hour standards. Fifty-six percent (n = 83) of Liaison Committee for Medical Education (LCME)-accredited medical schools responded to the survey. Of received responses, 98% of pediatric clerkships have some form of nighttime clinical experience; 49% of clerkships have medical students stay late, 24% of clerkships utilize night shifts, and 16% use a traditional call structure. Forty-five percent of clerkships report changing their nighttime clinical experience after implementation of the 2011 ACGME duty hour standards; 46% of clerkships that changed had previously used traditional call. Seventy-six percent of clerkships report having medical student duty hour standards at their medical school. The majority of pediatric clerkships in our survey include nighttime clinical experiences in their curriculum, although variability exists in the type of structure. Additionally, the new ACGME duty hour standards appear to affect clerkships directors' choice of structure. Copyright © 2014 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Advanced Practice Registered Nurses and Physician Assistants in Sleep Centers and Clinics: A Survey of Current Roles and Educational Background

PubMed Central

Colvin, Loretta; Cartwright, Ann; Collop, Nancy; Freedman, Neil; McLeod, Don; Weaver, Terri E.; Rogers, Ann E.

2014-01-01

Study Objectives: To survey Advanced Practice Registered Nurse (APRN) and Physician Assistant (PA) utilization, roles and educational background within the field of sleep medicine. Methods: Electronic surveys distributed to American Academy of Sleep Medicine (AASM) member centers and APRNs and PAs working within sleep centers and clinics. Results: Approximately 40% of responding AASM sleep centers reported utilizing APRNs or PAs in predominantly clinical roles. Of the APRNs and PAs surveyed, 95% reported responsibilities in sleep disordered breathing and more than 50% in insomnia and movement disorders. Most APRNs and PAs were prepared at the graduate level (89%), with sleep-specific education primarily through “on the job” training (86%). All APRNs surveyed were Nurse Practitioners (NPs), with approximately double the number of NPs compared to PAs. Conclusions: APRNs and PAs were reported in sleep centers at proportions similar to national estimates of NPs and PAs in physicians' offices. They report predominantly clinical roles, involving common sleep disorders. Given current predictions that the outpatient healthcare structure will change and the number of APRNs and PAs will increase, understanding the role and utilization of these professionals is necessary to plan for the future care of patients with sleep disorders. Surveyed APRNs and PAs reported a significant deficiency in formal and standardized sleep-specific education. Efforts to provide formal and standardized educational opportunities for APRNs and PAs that focus on their clinical roles within sleep centers could help fill a current educational gap. Citation: Colvin L, Cartwright Ann, Collop N, Freedman N, McLeod D, Weaver TE, Rogers AE. Advanced practice registered nurses and physician assistants in sleep centers and clinics: a survey of current roles and educational background. J Clin Sleep Med 2014;10(5):581-587. PMID:24812545

Glucose Measurement: Time for a Gold Standard

PubMed Central

Hagvik, Joakim

2007-01-01

There is no internationally recognized reference method for the measurement of blood glucose. The Centers for Disease Control and Prevention (CDC) highlighted the need for standardization some years ago when a project was started. The project objectives were to (1) investigate whether there are significant differences in calibration levels among currently used glucose monitors for home use and (2) develop a reference method for glucose determination. A first study confirmed the assumption that currently used home-use monitors differ significantly and that standardization is necessary in order to minimize variability and to improve patient care. As a reference method, CDC recommended a method based on isotope dilution gas chromatography–mass spectrometry, an assay that has received support from clinical chemists worldwide. CDC initiated a preliminary study to establish the suitability of this method, but then the project came to a halt. It is hoped that CDC, with support from the industry, as well as academic and professional organizations such as the American Association for Clinical Chemistry and International Federation of Clinical Chemistry and Laboratory Medicine, will be able to finalize the project and develop the long-awaited and much needed “gold standard” for glucose measurement. PMID:19888402

Perception Matters for Clinical Perfectionism and Social Anxiety

PubMed Central

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

2014-01-01

Despite research documenting a relationship between social anxiety and perfectionism, very little research has examined the relationship between social anxiety and clinical perfectionism, defined as the combination of high personal standards and high maladaptive perfectionistic evaluative concern. In the current studies we examined whether clinical perfectionism predicted social anxiety in a large sample of undergraduates (N = 602), in a clinical sample of participants diagnosed with social anxiety disorder (SAD; N = 180), and by using a variance decomposition model of self-and informant-report of perfectionism (N = 134). Using self-report, we found that an interaction of personal standards and evaluative concern predicted both social interaction anxiety and fear of scrutiny, but not in the theorized direction. Specifically, we found that self-report of low standards and high evaluative concern was associated with the highest levels of social anxiety, suggesting that when individuals with SAD hold low expectations for themselves combined with high concerns about evaluation, social anxiety symptoms may increase. Alternatively, when an informants’ perspective was considered, and more consistent with the original theory, we found that the interaction of informant-only report of personal standards and shared-report (between both primary participant and informant) of concern over mistakes was associated with self-reported social anxiety, such that high concern over mistakes and high personal standards predicted the highest levels of social anxiety. Theoretical, clinical, and measurement implications for clinical perfectionism are discussed. PMID:25486087

'Muscle-sparing' statins: preclinical profiles and future clinical use.

PubMed

Pfefferkorn, Jeffrey A

2009-03-01

Coronary heart disease (CHD) is a leading cause of death in the US, and hypercholesterolemia is a key risk factor for this disease. The current standard of care for treating hypercholesterolemia is the use of HMG-CoA reductase inhibitors, also known as statins, which block the rate-limiting step of cholesterol biosynthesis. In widespread clinical use, statins have proven safe and effective for both primary prevention of CHD and secondary prevention of coronary events. Results from several recent clinical trials have demonstrated that increasingly aggressive cholesterol-lowering therapy might offer additional protection against CHD compared with less aggressive treatment standards. While higher doses of current statin therapies are capable of achieving these more aggressive treatment goals, in certain cases statin-induced myalgia, the muscle pain or weakness that sometimes accompanies high-dose statin therapy, limits patient compliance with a treatment regimen. To address this limitation, efforts have been undertaken to develop highly hepatoselective statins that are capable of delivering best-in-class efficacy with minimized risk of dose-limiting myalgia. In this review, the preclinical and early clinical data for these next generation statins are discussed.

Antibody-mediated delivery of therapeutics for cancer therapy.

PubMed

Parakh, Sagun; Parslow, Adam C; Gan, Hui K; Scott, Andrew M

2016-01-01

Antibody-conjugated therapies (ACTs) combine the specificity of monoclonal antibodies to target cancer cells directly with highly potent payloads, often resulting in superior efficacy and/or reduced toxicity. This represents a new approach to the treatment of cancer. There have been highly promising clinical trial results using this approach with improvements in linker and payload technology. The breadth of current trials examining ACTs in haematological malignancies and solid tumours indicate the potential for clinical impact. This review will provide an overview of ACTs currently in clinical development as well as the principles of antibody delivery and types of payloads used, including cytotoxic drugs, radiolabelled isotopes, nanoparticle-based siRNA particles and immunotoxins. The focus of much of the clinical activity in ACTs has, understandably, been on their use as a monotherapy or in combination with standard of care drugs. This will continue, as will the search for better targets, linkers and payloads. Increasingly, as these drugs enter routine clinical care, important questions will arise regarding how to optimise ACT treatment approaches, including investigation of resistance mechanisms, biomarker and patient selection strategies, understanding of the unique toxicities of these drugs, and combinatorial approaches with standard therapies as well as emerging therapeutic agents like immunotherapy.

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

PubMed

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

2010-06-01

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

Systematic review of emergency medicine clinical practice guidelines: Implications for research and policy.

PubMed

Venkatesh, Arjun K; Savage, Dan; Sandefur, Benjamin; Bernard, Kenneth R; Rothenberg, Craig; Schuur, Jeremiah D

2017-01-01

Over 25 years, emergency medicine in the United States has amassed a large evidence base that has been systematically assessed and interpreted through ACEP Clinical Policies. While not previously studied in emergency medicine, prior work has shown that nearly half of all recommendations in medical specialty practice guidelines may be based on limited or inconclusive evidence. We sought to describe the proportion of clinical practice guideline recommendations in Emergency Medicine that are based upon expert opinion and low level evidence. Systematic review of clinical practice guidelines (Clinical Policies) published by the American College of Emergency Physicians from January 1990 to January 2016. Standardized data were abstracted from each Clinical Policy including the number and level of recommendations as well as the reported class of evidence. Primary outcomes were the proportion of Level C equivalent recommendations and Class III equivalent evidence. The primary analysis was limited to current Clinical Policies, while secondary analysis included all Clinical Policies. A total of 54 Clinical Policies including 421 recommendations and 2801 cited references, with an average of 7.8 recommendations and 52 references per guideline were included. Of 19 current Clinical Policies, 13 of 141 (9.2%) recommendations were Level A, 57 (40.4%) Level B, and 71 (50.4%) Level C. Of 845 references in current Clinical Policies, 67 (7.9%) were Class I, 272 (32.3%) Class II, and 506 (59.9%) Class III equivalent. Among all Clinical Policies, 200 (47.5%) recommendations were Level C equivalent, and 1371 (48.9%) of references were Class III equivalent. Emergency medicine clinical practice guidelines are largely based on lower classes of evidence and a majority of recommendations are expert opinion based. Emergency medicine appears to suffer from an evidence gap that should be prioritized in the national research agenda and considered by policymakers prior to developing future quality standards.

Liposomal bupivacaine for regional anesthesia.

PubMed

Uskova, Anna; O'Connor, Jessica E

2015-10-01

Using a regional block in a multimodal approach to postoperative analgesia management involves addressing, which local anesthetic and how much should be used to ensure adequate pain relief to reduce related morbidity and mortality. This article will review literature surrounding the recently approved formulation of slow release liposomal bupivacaine, define its proven benefits, and identify ongoing studies to further examine the utility of this novel formulation by various routes. Recent Phase II and III clinical trials have demonstrated the ability of liposomal bupivacaine to provide prolonged analgesia, maintain a high safety profile in therapeutic doses, and decrease opioid requirements when compared with placebo in local infiltration applications for up to 24 h. Between 24 and 72 h after study drug administration, there was minimal to no difference between EXPAREL and placebo treatments on mean pain intensity. Conventional bupivacaine or ropivacaine groups (current standard practice in many hospitals in the USA) were not compared. In addition, the analgesic efficacy, cost-effectiveness, and safety profile of liposomal bupivacaine has not thoroughly been studied in various standard clinical settings such as perineural, intrathecal, and epidural administration. Current published data do not provide superior clinical results for EXPAREL over conventional bupivacaine based upon the lack of adequately powered multicentered clinical trials with comparison groups. Further investigation is necessary to identify the analgesic efficacy and safety profile of liposomal bupivacaine versus standard local anesthetics and to define the optimal clinical indication for liposomal bupivacaine administration in regional anesthesia.

Electrical safety Q&A. A reference guide for the clinical engineer.

PubMed

2005-02-01

This guide, which ECRI developed to answer the electrical safety questions most frequently asked by member hospitals, features practical advice for addressing electrical safety concerns in the healthcare environment. Questions addressed include: STANDARDS AND APPROVALS: What electrical safety standards apply? How do NFPA 99 and IEC 60601-1 differ? What organizations approve medical devices? LEAKAGE CURRENT LIMITS AND TESTING: How are leakage current limits established? What limits apply to equipment used in the hospital? And how should the limits be applied in special cases, such as the use of PCs in the patient care area or equipment used in the clinical laboratory? ISOLATED POWER: What are its advantages and disadvantages, and is isolated power needed in the operating room? Other topics addressed include double insulation, ground-fault circuit interrupters (GFCIs), and requirements for medical devices used in the home. Supplementary articles discuss acceptable alternatives to UL listing, the use of Hospital Grade plugs, the limitations of leakage current testing of devices connected to isolated power systems, and the debate about whether to designate ORs as wet locations. Experienced clinical engineers should find this guide to be a handy reference, while those new to the field should find it to be a helpful educational resource.

Adolescent health care maintenance in a teen-friendly clinic.

PubMed

Chaisson, Nicole; Shore, William B

2014-09-01

Adolescence is marked by complex physical, cognitive, social, and emotional development, which can be stressful for families and adolescents. Before the onset of puberty, providers should clearly lay the groundwork for clinical care and office visits during the adolescent years. This article addresses the guidelines and current legal standards for confidentiality in adolescent care, the most frequently used psychosocial screening tools, and current recommendations for preventive health services and immunizations. Through the creation of teen-friendly clinics, primary care providers are well positioned to offer guidance and support to teens and their parents during this time of transition and growth. Copyright © 2014 Elsevier Inc. All rights reserved.

Methodology of Clinical Trials Aimed at Assessing Interventions for Cutaneous Leishmaniasis

PubMed Central

Olliaro, Piero; Vaillant, Michel; Arana, Byron; Grogl, Max; Modabber, Farrokh; Magill, Alan; Lapujade, Olivier; Buffet, Pierre; Alvar, Jorge

2013-01-01

The current evidence-base for recommendations on the treatment of cutaneous leishmaniasis (CL) is generally weak. Systematic reviews have pointed to a general lack of standardization of methods for the conduct and analysis of clinical trials of CL, compounded with poor overall quality of several trials. For CL, there is a specific need for methodologies which can be applied generally, while allowing the flexibility needed to cover the diverse forms of the disease. This paper intends to provide clinical investigators with guidance for the design, conduct, analysis and report of clinical trials of treatments for CL, including the definition of measurable, reproducible and clinically-meaningful outcomes. Having unified criteria will help strengthen evidence, optimize investments, and enhance the capacity for high-quality trials. The limited resources available for CL have to be concentrated in clinical studies of excellence that meet international quality standards. PMID:23556016

Achieving Excellence Through Contemporary and Relevant Psychiatric-Mental Health Nursing Standards of Practice.

PubMed

McInnis-Perry, Gloria; Greene, Ann; Mina, Elaine Santa

2015-09-01

Standards of practice (SOPs) comprise competency statements, which are grounded in current knowledge and research, and provide foundations for performance that support professional accountability. The nursing profession, and specifically the psychiatric-mental health specialty of nursing practice in Canada, develops and revises practice standards regularly. The current article describes the collaborative, evidence-informed journey of the Canadian Federation of Mental Health Nurses during its fourth revision of the Canadian Psychiatric-Mental Health Nursing SOPs. An intraprofessional team of psychiatric-mental health nurses from the clinical, academic, research, and policy areas developed and nurtured collaborative processes that emphasize collegial and authentic relationships. Effective communication and a respectful learning environment supported the process for all members of the team. The current article provides recommendations for other professional organizations considering developing and/or revising SOPs. Copyright 2015, SLACK Incorporated.

Assessing the readiness of precision medicine interoperabilty: An exploratory study of the National Institutes of Health genetic testing registry.

PubMed

Ronquillo, Jay G; Weng, Chunhua; Lester, William T

2017-11-17

  Precision medicine involves three major innovations currently taking place in healthcare:  electronic health records, genomics, and big data.  A major challenge for healthcare providers, however, is understanding the readiness for practical application of initiatives like precision medicine.   To better understand the current state and challenges of precision medicine interoperability using a national genetic testing registry as a starting point, placed in the context of established interoperability formats.   We performed an exploratory analysis of the National Institutes of Health Genetic Testing Registry.  Relevant standards included Health Level Seven International Version 3 Implementation Guide for Family History, the Human Genome Organization Gene Nomenclature Committee (HGNC) database, and Systematized Nomenclature of Medicine - Clinical Terms (SNOMED CT).  We analyzed the distribution of genetic testing laboratories, genetic test characteristics, and standardized genome/clinical code mappings, stratified by laboratory setting. There were a total of 25472 genetic tests from 240 laboratories testing for approximately 3632 distinct genes.  Most tests focused on diagnosis, mutation confirmation, and/or risk assessment of germline mutations that could be passed to offspring.  Genes were successfully mapped to all HGNC identifiers, but less than half of tests mapped to SNOMED CT codes, highlighting significant gaps when linking genetic tests to standardized clinical codes that explain the medical motivations behind test ordering.  Conclusion:  While precision medicine could potentially transform healthcare, successful practical and clinical application will first require the comprehensive and responsible adoption of interoperable standards, terminologies, and formats across all aspects of the precision medicine pipeline.

Current Approaches in the Treatment of Relapsed and Refractory Acute Myeloid Leukemia

PubMed Central

Ramos, Nestor R.; Mo, Clifton C.; Karp, Judith E.; Hourigan, Christopher S.

2015-01-01

The limited sensitivity of the historical treatment response criteria for acute myeloid leukemia (AML) has resulted in a different paradigm for treatment compared with most other cancers presenting with widely disseminated disease. Initial cytotoxic induction chemotherapy is often able to reduce tumor burden to a level sufficient to meet the current criteria for “complete” remission. Nevertheless, most AML patients ultimately die from their disease, most commonly as clinically evident relapsed AML. Despite a variety of available salvage therapy options, prognosis in patients with relapsed or refractory AML is generally poor. In this review, we outline the commonly utilized salvage cytotoxic therapy interventions and then highlight novel investigational efforts currently in clinical trials using both pathway-targeted agents and immunotherapy based approaches. We conclude that there is no current standard of care for adult relapsed or refractory AML other than offering referral to an appropriate clinical trial. PMID:25932335

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

NASA Astrophysics Data System (ADS)

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.

The Wechsler ACS Social Perception Subtest: A Preliminary Comparison with Other Measures of Social Cognition

ERIC Educational Resources Information Center

Kandalaft, Michelle R.; Didehbani, Nyaz; Cullum, C. Munro; Krawczyk, Daniel C.; Allen, Tandra T.; Tamminga, Carol A.; Chapman, Sandra B.

2012-01-01

Relative to other cognitive areas, there are few clinical measures currently available to assess social perception. A new standardized measure, the Wechsler Advanced Clinical Solutions (ACS) Social Perception subtest, addresses some limitations of existing measures; however, little is known about this new test. The first goal of this investigation…

Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

PubMed

Sharp, Susan E; Miller, Melissa B; Hindler, Janet

2015-12-01

The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use "equivalent QC" (EQC) or the Clinical and Laboratory Standards Institute (CLSI) standards alone for quality control of their microbiology systems. The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Implementation Considerations for Multisite Clinical Trials with Cognitive Neuroscience Tasks

PubMed Central

Keefe, Richard S. E.; Harvey, Philip D.

2008-01-01

Multisite clinical trials aimed at cognitive enhancement across various neuropsychiatric conditions have employed standard neuropsychological tests as outcome measures. While these tests have enjoyed wide clinical use and have proven reliable and predictive of functional disability, a number of implementation challenges have arisen when these tests are used in clinical trials. These issues are likely to be magnified in future studies when cognitive neuroscience (CN) procedures are explored in these trials, because in their current forms CN procedures are less standardized and more difficult to teach and monitor. For multisite trials, we anticipate that the most challenging issues will include assuring tester competence, monitoring tester performance, specific challenges with complex assessment methods, and having resources available for adequate monitoring of data quality. Suggestions for overcoming these implementation challenges are offered. PMID:18495645

Advanced practice registered nurses and physician assistants in sleep centers and clinics: a survey of current roles and educational background.

PubMed

Colvin, Loretta; Cartwright, Ann; Collop, Nancy; Freedman, Neil; McLeod, Don; Weaver, Terri E; Rogers, Ann E

2014-05-15

To survey Advanced Practice Registered Nurse (APRN) and Physician Assistant (PA) utilization, roles and educational background within the field of sleep medicine. Electronic surveys distributed to American Academy of Sleep Medicine (AASM) member centers and APRNs and PAs working within sleep centers and clinics. Approximately 40% of responding AASM sleep centers reported utilizing APRNs or PAs in predominantly clinical roles. Of the APRNs and PAs surveyed, 95% reported responsibilities in sleep disordered breathing and more than 50% in insomnia and movement disorders. Most APRNs and PAs were prepared at the graduate level (89%), with sleep-specific education primarily through "on the job" training (86%). All APRNs surveyed were Nurse Practitioners (NPs), with approximately double the number of NPs compared to PAs. APRNs and PAs were reported in sleep centers at proportions similar to national estimates of NPs and PAs in physicians' offices. They report predominantly clinical roles, involving common sleep disorders. Given current predictions that the outpatient healthcare structure will change and the number of APRNs and PAs will increase, understanding the role and utilization of these professionals is necessary to plan for the future care of patients with sleep disorders. Surveyed APRNs and PAs reported a significant deficiency in formal and standardized sleep-specific education. Efforts to provide formal and standardized educational opportunities for APRNs and PAs that focus on their clinical roles within sleep centers could help fill a current educational gap.

An approach for the semantic interoperability of ISO EN 13606 and OpenEHR archetypes.

PubMed

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

2010-10-01

The communication between health information systems of hospitals and primary care organizations is currently an important challenge to improve the quality of clinical practice and patient safety. However, clinical information is usually distributed among several independent systems that may be syntactically or semantically incompatible. This fact prevents healthcare professionals from accessing clinical information of patients in an understandable and normalized way. In this work, we address the semantic interoperability of two EHR standards: OpenEHR and ISO EN 13606. Both standards follow the dual model approach which distinguishes information and knowledge, this being represented through archetypes. The solution presented here is capable of transforming OpenEHR archetypes into ISO EN 13606 and vice versa by combining Semantic Web and Model-driven Engineering technologies. The resulting software implementation has been tested using publicly available collections of archetypes for both standards.

The RICORDO approach to semantic interoperability for biomedical data and models: strategy, standards and solutions

PubMed Central

2011-01-01

Background The practice and research of medicine generates considerable quantities of data and model resources (DMRs). Although in principle biomedical resources are re-usable, in practice few can currently be shared. In particular, the clinical communities in physiology and pharmacology research, as well as medical education, (i.e. PPME communities) are facing considerable operational and technical obstacles in sharing data and models. Findings We outline the efforts of the PPME communities to achieve automated semantic interoperability for clinical resource documentation in collaboration with the RICORDO project. Current community practices in resource documentation and knowledge management are overviewed. Furthermore, requirements and improvements sought by the PPME communities to current documentation practices are discussed. The RICORDO plan and effort in creating a representational framework and associated open software toolkit for the automated management of PPME metadata resources is also described. Conclusions RICORDO is providing the PPME community with tools to effect, share and reason over clinical resource annotations. This work is contributing to the semantic interoperability of DMRs through ontology-based annotation by (i) supporting more effective navigation and re-use of clinical DMRs, as well as (ii) sustaining interoperability operations based on the criterion of biological similarity. Operations facilitated by RICORDO will range from automated dataset matching to model merging and managing complex simulation workflows. In effect, RICORDO is contributing to community standards for resource sharing and interoperability. PMID:21878109

Perception matters for clinical perfectionism and social anxiety.

PubMed

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

2015-01-01

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

Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence

PubMed Central

Ud-Din, Sara; Bayat, Ardeshir

2014-01-01

Electrical stimulation (ES) has been shown to have beneficial effects in wound healing. It is important to assess the effects of ES on cutaneous wound healing in order to ensure optimization for clinical practice. Several different applications as well as modalities of ES have been described, including direct current (DC), alternating current (AC), high-voltage pulsed current (HVPC), low-intensity direct current (LIDC) and electrobiofeedback ES. However, no one method has been advocated as the most optimal for the treatment of cutaneous wound healing. Therefore, this review aims to examine the level of evidence (LOE) for the application of different types of ES to enhance cutaneous wound healing in the skin. An extensive search was conducted to identify relevant clinical studies utilising ES for cutaneous wound healing since 1980 using PubMed, Medline and EMBASE. A total of 48 studies were evaluated and assigned LOE. All types of ES demonstrated positive effects on cutaneous wound healing in the majority of studies. However, the reported studies demonstrate contrasting differences in the parameters and types of ES application, leading to an inability to generate sufficient evidence to support any one standard therapeutic approach. Despite variations in the type of current, duration, and dosing of ES, the majority of studies showed a significant improvement in wound area reduction or accelerated wound healing compared to the standard of care or sham therapy as well as improved local perfusion. The limited number of LOE-1 trials for investigating the effects of ES in wound healing make critical evaluation and assessment somewhat difficult. Further, better-designed clinical trials are needed to improve our understanding of the optimal dosing, timing and type of ES to be used. PMID:27429287

Therapeutic efficacy of alternative primaquine regimens to standard treatment in preventing relapses by Plasmodium vivax: A systematic review and meta-analysis.

PubMed

Zuluaga-Idarraga, Lina Marcela; Tamayo Perez, María-Eulalia; Aguirre-Acevedo, Daniel Camilo

2015-12-30

To compare efficacy and safety of primaquine regimens currently used to prevent relapses by P. vivax. A systematic review was carried out to identify clinical trials evaluating efficacy and safety to prevent malaria recurrences by P. vivax of primaquine regimen 0.5 mg/kg/ day for 7 or 14 days compared to standard regimen of 0.25 mg/kg/day for 14 days. Efficacy of primaquine according to cumulative incidence of recurrences after 28 days was determined. The overall relative risk with fixed-effects meta-analysis was estimated. For the regimen 0.5 mg/kg/day/7 days were identified 7 studies, which showed an incidence of recurrence between 0% and 20% with follow-up 60-210 days; only 4 studies comparing with the standard regimen 0.25 mg/kg/day/14 days and no difference in recurrences between both regimens (RR= 0.977, 95% CI= 0.670 to 1.423) were found. 3 clinical trials using regimen 0.5 mg/kg/day/14 days with an incidence of recurrences between 1.8% and 18.0% during 330-365 days were identified; only one study comparing with the standard regimen (RR= 0.846, 95% CI= 0.484 to 1.477). High risk of bias and differences in handling of included studies were found. Available evidence is insufficient to determine whether currently PQ regimens used as alternative rather than standard treatment have better efficacy and safety in preventing relapse of P. vivax. Clinical trials are required to guide changes in treatment regimen of malaria vivax.

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

PubMed

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-nine percent of respondents wanted to improve their assessments, identifying individual, environmental and measure-specific barriers. The most common barriers were lack of time and knowledge. This study offers new information on issues affecting the evaluation of balance in clinical settings from a broad sample of physiotherapists. Continued work to address barriers by specific practice area will be critical for the success of any intervention attempting to implement optimal balance assessment practices in the clinical setting.

[The current state and prospect of Chinese medicine gastroenterology].

PubMed

Zhang, Sheng-Sheng; Zhou, Tao

2012-03-01

The progress and existent problems of Chinese medicine (CM) gastroenterology since the National Eleventh Five-Year Plan were discussed in this article in terms of theory innovation, formulation of clinical pathway and diagnosis-treatment consensus, efficacy assessment, formulation of efficacy assessment scale, advantage diseases, and exploration of the syndrome standardization, progress in science research, academic exchange, and the construction of study platform, and so on. Meanwhile, the development of CM gastroenterology was prospected in the following five aspects: to enhance the theory inheritance and innovation, the construction of discipline standardization; to establish scientific clinical efficacy assessment methods and the standard system; to expend treatment technologies and feature therapies; and to clarify the modern scientific connotation of CM theory and treatment.

A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection

PubMed Central

2016-01-01

BACKGROUND Data from studies in nonhuman primates suggest that the triple monoclonal antibody cocktail ZMapp is a promising immune-based treatment for Ebola virus disease (EVD). METHODS Beginning in March 2015, we conducted a randomized, controlled trial of ZMapp plus the current standard of care as compared with the current standard of care alone in patients with EVD that was diagnosed in West Africa by polymerase-chain-reaction (PCR) assay. Eligible patients of any age were randomly assigned in a 1:1 ratio to receive either the current standard of care or the current standard of care plus three intravenous infusions of ZMapp (50 mg per kilogram of body weight, administered every third day). Patients were stratified according to baseline PCR cycle-threshold value for the virus (≤22 vs. >22) and country of enrollment. Oral favipiravir was part of the current standard of care in Guinea. The primary end point was mortality at 28 days. RESULTS A total of 72 patients were enrolled at sites in Liberia, Sierra Leone, Guinea, and the United States. Of the 71 patients who could be evaluated, 21 died, representing an overall case fatality rate of 30%. Death occurred in 13 of 35 patients (37%) who received the current standard of care alone and in 8 of 36 patients (22%) who received the current standard of care plus ZMapp. The observed posterior probability that ZMapp plus the current standard of care was superior to the current standard of care alone was 91.2%, falling short of the prespecified threshold of 97.5%. Frequentist analyses yielded similar results (absolute difference in mortality with ZMapp, −15 percentage points; 95% confidence interval, −36 to 7). Baseline viral load was strongly predictive of both mortality and duration of hospitalization in all age groups. CONCLUSIONS In this randomized, controlled trial of a putative therapeutic agent for EVD, although the estimated effect of ZMapp appeared to be beneficial, the result did not meet the prespecified statistical threshold for efficacy. (Funded by the National Institute of Allergy and Infectious Diseases and others; PREVAIL II ClinicalTrials.gov number, NCT02363322.) PMID:27732819

SMART on FHIR Genomics: facilitating standardized clinico-genomic apps.

PubMed

Alterovitz, Gil; Warner, Jeremy; Zhang, Peijin; Chen, Yishen; Ullman-Cullere, Mollie; Kreda, David; Kohane, Isaac S

2015-11-01

Supporting clinical decision support for personalized medicine will require linking genome and phenome variants to a patient's electronic health record (EHR), at times on a vast scale. Clinico-genomic data standards will be needed to unify how genomic variant data are accessed from different sequencing systems. A specification for the basis of a clinic-genomic standard, building upon the current Health Level Seven International Fast Healthcare Interoperability Resources (FHIR®) standard, was developed. An FHIR application protocol interface (API) layer was attached to proprietary sequencing platforms and EHRs in order to expose gene variant data for presentation to the end-user. Three representative apps based on the SMART platform were built to test end-to-end feasibility, including integration of genomic and clinical data. Successful design, deployment, and use of the API was demonstrated and adopted by HL7 Clinical Genomics Workgroup. Feasibility was shown through development of three apps by various types of users with background levels and locations. This prototyping work suggests that an entirely data (and web) standards-based approach could prove both effective and efficient for advancing personalized medicine. © 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.

Clinical guidelines: proliferation and medicolegal significance.

PubMed Central

Hurwitz, B

1994-01-01

Guidelines seeking to influence and regulate clinical activity are currently gaining a new cultural ascendancy on both sides of the Atlantic. Statutory agencies may be charged with developing clinical guidelines, and civil courts, in deciding actions in negligence, could be influenced by standards of care expressed in guideline statements. Clinical guidelines are not accorded unchallengeable status: they have been subject to careful scrutiny by British and American courts to establish their authenticity and relevance. In the United States, compliance with clinical guidelines cannot be used as a defence against liability if a physician's conduct is held to have been negligent, and third party organisations can be held liable if their clinical guidelines are found to be a contributory cause of patient harm. Guidelines have not usurped the role of the expert witness in court. The importance the law attaches to customary practice means that atypical or bizarre guidelines are unlikely to be accepted as embodying a legally required standard of clinical care. PMID:10136259

Clinical applications of decellularized extracellular matrices for tissue engineering and regenerative medicine.

PubMed

Parmaksiz, Mahmut; Dogan, Arin; Odabas, Sedat; Elçin, A Eser; Elçin, Y Murat

2016-03-17

Decellularization is the process of removing the cellular components from tissues or organs. It is a promising technology for obtaining a biomaterial with a highly preserved extracellular matrix (ECM), which may also act as a biological scaffold for tissue engineering and regenerative therapies. Decellularized products are gaining clinical importance and market space due to their ease of standardized production, constant availability for grafting and mechanical or biochemical superiority against competing clinical options, yielding clinical results ahead of the ones with autografts in some applications. Current drawbacks and limitations of traditional treatments and clinical applications can be overcome by using decellularized or acellular matrices. Several companies are leading the market with versatile acellular products designed for diverse use in the reconstruction of tissues and organs. This review describes ECM-based decellularized and acellular products that are currently in use for different branches of clinic.

Clinical utility of cerebrospinal fluid biomarkers in the diagnosis of early Alzheimer’s disease

PubMed Central

Blennow, Kaj; Dubois, Bruno; Fagan, Anne M.; Lewczuk, Piotr; de Leon, Mony J.; Hampel, Harald

2015-01-01

Several potential disease-modifying drugs for Alzheimer’s disease (AD) have failed to show any effect on disease progression in clinical trials, conceivably because the AD subjects are already too advanced to derive clinical benefit from treatment and because diagnosis based on clinical criteria alone introduces a high misdiagnosis rate. Thus, well-validated biomarkers for early detection and accurate diagnosis are crucial. Low cerebrospinal fluid (CSF) concentrations of the amyloid-β (Aβ1-42) peptide, in combination with high total tau and phosphorylated tau, are sensitive and specific biomarkers highly predictive of progression to AD dementia in patients with mild cognitive impairment. However, interlaboratory variations in the results seen with currently available immunoassays are of concern. Recent worldwide standardization efforts and quality control programs include standard operating procedures for both preanalytical (e.g., lumbar puncture and sample handling) and analytical (e.g., preparation of calibration curve) procedures. Efforts are also ongoing to develop highly reproducible assays on fully automated instruments. These global standardization and harmonization measures will provide the basis for the generalized international application of CSF bio-markers for both clinical trials and routine clinical diagnosis of AD. PMID:24795085

Implementation of standardization in clinical practice: not always an easy task.

PubMed

Panteghini, Mauro

2012-02-29

As soon as a new reference measurement system is adopted, clinical validation of correctly calibrated commercial methods should take place. Tracing back the calibration of routine assays to a reference system can actually modify the relation of analyte results to existing reference intervals and decision limits and this may invalidate some of the clinical decision-making criteria currently used. To maintain the accumulated clinical experience, the quantitative relationship to the previous calibration system should be established and, if necessary, the clinical decision-making criteria should be adjusted accordingly. The implementation of standardization should take place in a concerted action of laboratorians, manufacturers, external quality assessment scheme organizers and clinicians. Dedicated meetings with manufacturers should be organized to discuss the process of assay recalibration and studies should be performed to obtain convincing evidence that the standardization works, improving result comparability. Another important issue relates to the surveillance of the performance of standardized assays through the organization of appropriate analytical internal and external quality controls. Last but not least, uncertainty of measurement that fits for this purpose must be defined across the entire traceability chain, starting with the available reference materials, extending through the manufacturers and their processes for assignment of calibrator values and ultimately to the final result reported to clinicians by laboratories.

The neurofibromatoses.

PubMed

Ferner, Rosalie E

2010-04-01

Neurofibromatosis 1 (NF1) and neurofibromatosis 2 (NF2) are inherited autosomal dominant disorders that have a significant impact on the nervous system and predispose to tumour formation. The current nomenclature makes NF1 and NF2 awkward bedfellows because they are clinically and genetically separate disorders. Neurofibromas are characteristic of NF1, a common condition with major skin involvement and many clinical complications. By contrast, schwannomas are the distinctive lesions in NF2, cutaneous signs are less prominent in this rarer disorder and clinical manifestations are largely restricted to the nervous system and eye. The current aim of neurofibromatosis specialists is to provide cohesive standards of care for everyone with neurofibromatosis and to devise standardised protocols for assessment and management within a multidisciplinary setting.

Clinical trials needed to evaluate compression therapy in breast cancer related lymphedema (BCRL). Proposals from an expert group.

PubMed

Partsch, H; Stout, N; Forner-Cordero, I; Flour, M; Moffatt, C; Szuba, A; Milic, D; Szolnoky, G; Brorson, H; Abel, M; Schuren, J; Schingale, F; Vignes, S; Piller, N; Döller, W

2010-10-01

A mainstay of lymphedema management involves the use of compression therapy. Compression therapy application is variable at different levels of disease severity. Evidence is scant to direct clinicians in best practice regarding compression therapy use. Further, compression clinical trials are fragmented and poorly extrapolable to the greater population. An ideal construct for conducting clinical trials in regards to compression therapy will promote parallel global initiatives based on a standard research agenda. The purpose of this article is to review current evidence in practice regarding compression therapy for BCRL management and based on this evidence, offer an expert consensus recommendation for a research agenda and prescriptive trials. Recommendations herein focus solely on compression interventions. This document represents the proceedings of a session organized by the International Compression Club (ICC) in June 2009 in Ponzano (Veneto, Italy). The purpose of the meeting was to enable a group of experts to discuss the existing evidence for compression treatment in breast cancer related lymphedema (BCRL) concentrating on areas where randomized controlled trials (RCTs) are lacking. The current body of research suggests efficacy of compression interventions in the treatment and management of lymphedema. However, studies to date have failed to adequately address various forms of compression therapy and their optimal application in BCRL. We offer recommendations for standardized compression research trials for prophylaxis of arm lymphedema and for the management of chronic BCRL. Suggestions are also made regarding; inclusion and exclusion criteria, measurement methodology and additional variables of interest for researchers to capture. This document should inform future research trials in compression therapy and serve as a guide to clinical researchers, industry researchers and lymphologists regarding the strengths, weaknesses and shortcomings of the current literature. By providing this construct for research trials, the authors aim to support evidence-based therapy interventions, promote a cohesive, standardized and informative body of literature to enhance clinical outcomes, improve the quality of future research trials, inform industry innovation and guide policy related to BCRL.

Dendritic cells for active immunotherapy: optimizing design and manufacture in order to develop commercially and clinically viable products.

PubMed

Nicolette, C A; Healey, D; Tcherepanova, I; Whelton, P; Monesmith, T; Coombs, L; Finke, L H; Whiteside, T; Miesowicz, F

2007-09-27

Dendritic cell (DC) active immunotherapy is potentially efficacious in a broad array of malignant disease settings. However, challenges remain in optimizing DC-based therapy for maximum clinical efficacy within manufacturing processes that permit quality control and scale-up of consistent products. In this review we discuss the critical issues that must be addressed in order to optimize DC-based product design and manufacture, and highlight the DC based platforms currently addressing these issues. Variables in DC-based product design include the type of antigenic payload used, DC maturation steps and activation processes, and functional assays. Issues to consider in development include: (a) minimizing the invasiveness of patient biological material collection; (b) minimizing handling and manipulations of tissue at the clinical site; (c) centralized product manufacturing and standardized processing and capacity for commercial-scale production; (d) rapid product release turnaround time; (e) the ability to manufacture sufficient product from limited starting material; and (f) standardized release criteria for DC phenotype and function. Improvements in the design and manufacture of DC products have resulted in a handful of promising leads currently in clinical development.

Mesenchymal stromal cell-based therapy: Regulatory and translational aspects in gastroenterology.

PubMed

Dothel, Giovanni; Raschi, Emanuel; Rimondini, Roberto; De Ponti, Fabrizio

2016-11-07

The past decade has witnessed an outstanding scientific production focused towards the possible clinical applications of mesenchymal stromal cells (MSCs) in autoimmune and chronic inflammatory diseases. This raised the need of novel standards to adequately address quality, efficacy and safety issues of this advanced therapy. The development of a streamlined regulation is currently hampered by the complexity of analyzing dynamic biological entities rather than chemicals. Although numerous pieces of evidence show efficacy in reducing intestinal inflammation, some inconsistencies between the mechanisms of action of rodent vs human MSCs suggest caution before assigning translational value to preclinical studies. Preliminary evidence from clinical trials showed efficacy of MSCs in the treatment of fistulizing Crohn's disease (CD), and preparations of heterologous MSCs for CD treatment are currently tested in ongoing clinical trials. However, safety issues, especially in long-term treatment, still require solid clinical data. In this regard, standardized guidelines for appropriate dosing and methods of infusion could enhance the likelihood to predict more accurately the number of responders and the duration of remission periods. In addition, elucidating MSC mechanisms of action could lead to novel and more reliable formulations such as those derived from the MSCs themselves ( e.g ., supernatants).

Molecular and Nonmolecular Diagnostic Methods for Invasive Fungal Infections

PubMed Central

Arvanitis, Marios; Anagnostou, Theodora; Fuchs, Beth Burgwyn; Caliendo, Angela M.

2014-01-01

SUMMARY Invasive fungal infections constitute a serious threat to an ever-growing population of immunocompromised individuals and other individuals at risk. Traditional diagnostic methods, such as histopathology and culture, which are still considered the gold standards, have low sensitivity, which underscores the need for the development of new means of detecting fungal infectious agents. Indeed, novel serologic and molecular techniques have been developed and are currently under clinical evaluation. Tests like the galactomannan antigen test for aspergillosis and the β-glucan test for invasive Candida spp. and molds, as well as other antigen and antibody tests, for Cryptococcus spp., Pneumocystis spp., and dimorphic fungi, have already been established as important diagnostic approaches and are implemented in routine clinical practice. On the other hand, PCR and other molecular approaches, such as matrix-assisted laser desorption ionization (MALDI) and fluorescence in situ hybridization (FISH), have proved promising in clinical trials but still need to undergo standardization before their clinical use can become widespread. The purpose of this review is to highlight the different diagnostic approaches that are currently utilized or under development for invasive fungal infections and to identify their performance characteristics and the challenges associated with their use. PMID:24982319

Management of Parkinson׳s disease: Current and future pharmacotherapy.

PubMed

Kakkar, Ashish Kumar; Dahiya, Neha

2015-03-05

Parkinson׳s disease (PD) is chronic progressive neurodegenerative disorder characterized by profound loss of dopaminergic neurons in the nigrostriatal pathway. It is recognized by the cardinal clinical features of bradykinesia, rigidity, tremor and postural instability. Current therapeutic options are primarily dopamine replacement strategies that only provide symptomatic improvement without affecting progressive neuronal loss. These treatments often fail to provide sustained clinical benefit and most patients develop motor fluctuations and dyskinesias as the disease progresses. Additionally, non-motor symptoms such as autonomic disturbances, sensory alterations, olfactory dysfunction, mood disorders, sleep disturbances and cognitive impairment cause considerable functional disability in these patients and these features often fail to respond to standard dopaminergic treatments. This mini review outlines the current pharmacotherapeutic options for PD and highlights the emerging experimental therapies in various phases of clinical development. Copyright © 2015 Elsevier B.V. All rights reserved.

Carney v Newton: expert evidence about the standard of clinical notes.

PubMed

Faunce, Thomas; Hammer, Ingrid; Jefferys, Susannah

2007-12-01

In Carney v Newton [2006] TASSC 4 the Tasmanian Supreme Court heard a claim that the defendant breached his duty of care by failing to properly diagnose and treat a node positive carcinoma in the plaintiff's breast tissue. At trial, argument turned on the actual dialogue that took place during the initial consultation, with significant reliance on the clinical notes of the defendant. The court gave considerable weight to "expert" witnesses in ascertaining the acceptability of the defendant's conduct concerning the maintenance and interpretation of his clinical notes. This raises important questions in relation to proof of quality of medical records as part of the current professional standard of care, as modified by recent legislation in most jurisdictions.

Security and Privacy in a DACS.

PubMed

Delgado, Jaime; Llorente, Silvia; Pàmies, Martí; Vilalta, Josep

2016-01-01

The management of electronic health records (EHR), in general, and clinical documents, in particular, is becoming a key issue in the daily work of Healthcare Organizations (HO). The need for providing secure and private access to, and storage for, clinical documents together with the need for HO to interoperate, raises a number of issues difficult to solve. Many systems are in place to manage EHR and documents. Some of these Healthcare Information Systems (HIS) follow standards in their document structure and communications protocols, but many do not. In fact, they are mostly proprietary and do not interoperate. Our proposal to solve the current situation is the use of a DACS (Document Archiving and Communication System) for providing security, privacy and standardized access to clinical documents.

Chemotherapy Change Improves Pancreatic Cancer Outcomes

Cancer.gov

For people with early-stage pancreatic cancer, results from two clinical trials suggest that altering the type and timing of chemotherapy improves survival. The findings will likely change the standard of care, as this Cancer Currents post explains.

Defining sarcopenia

USDA-ARS?s Scientific Manuscript database

Currently there is no standardized definition of sarcopenia. This hampers the clinical management of sarcopenia and retards the development and regulatory approval of interventions to reduce the progression of this common and debilitating condition in the elderly. Nine definitions of sarcopenia have...

Current challenges in diagnostic imaging of venous thromboembolism.

PubMed

Huisman, Menno V; Klok, Frederikus A

2015-01-01

Because the clinical diagnosis of deep-vein thrombosis and pulmonary embolism is nonspecific, integrated diagnostic approaches for patients with suspected venous thromboembolism have been developed over the years, involving both non-invasive bedside tools (clinical decision rules and D-dimer blood tests) for patients with low pretest probability and diagnostic techniques (compression ultrasound for deep-vein thrombosis and computed tomography pulmonary angiography for pulmonary embolism) for those with a high pretest probability. This combination has led to standardized diagnostic algorithms with proven safety for excluding venous thrombotic disease. At the same time, it has become apparent that, as a result of the natural history of venous thrombosis, there are special patient populations in which the current standard diagnostic algorithms are not sufficient. In this review, we present 3 evidence-based patient cases to underline recent developments in the imaging diagnosis of venous thromboembolism. © 2015 by The American Society of Hematology. All rights reserved.

Assessing Intimate Relationships of Chinese Couples in Taiwan Using the Marital Satisfaction Inventory-Revised.

PubMed

Lou, Yu-Chiung; Lin, Chien-Heng; Chen, Chien-Min; Balderrama-Durbin, Christina; Snyder, Douglas K

2016-06-01

The current study examined the psychometric characteristics of the Chinese translation of the Marital Satisfaction Inventory-Revised (MSI-R) in a community sample of 117 couples from Taiwan. The Chinese MSI-R demonstrated moderate to strong internal consistency. Confirmatory factor analysis revealed similar scale factor structures in the Taiwanese and U.S. standardization samples. Mean profile comparisons between the current Taiwanese sample and the original MSI-R standardization sample revealed statistically significant but small differences on several subscales. Overall, the psychometric characteristics of the Chinese MSI-R lend support to its use with couples from diverse cultural backgrounds whose sole or preferred language is Chinese. It may also be appropriate to use the MSI-R in clinical settings for prevention or intervention efforts directed at Chinese-speaking couples. The implications of these findings for clinical and research purposes are discussed. © The Author(s) 2015.

[Thinking on designation of sham acupuncture in clinical research].

PubMed

Pan, Li-Jia; Chen, Bo; Zhao, Xue; Guo, Yi

2014-01-01

Randomized controlled trials (RCT) is the source of the raw data of evidence-based medicine. Blind method is adopted in most of the high-quality RCT. Sham acupuncture is the main form of blinded in acupuncture clinical trial. In order to improve the quality of acupuncture clinical trail, based on the necessity of sham acupuncture in clinical research, the current situation as well as the existing problems of sham acupuncture, suggestions were put forward from the aspects of new way and new designation method which can be adopted as reference, and factors which have to be considered during the process of implementing. Various subjective and objective factors involving in the process of trial should be considered, and used of the current international standards, try to be quantification, and carry out strict quality monitoring.

LORENZ: a system for planning long-bone fracture reduction

NASA Astrophysics Data System (ADS)

Birkfellner, Wolfgang; Burgstaller, Wolfgang; Wirth, Joachim; Baumann, Bernard; Jacob, Augustinus L.; Bieri, Kurt; Traud, Stefan; Strub, Michael; Regazzoni, Pietro; Messmer, Peter

2003-05-01

Long bone fractures belong to the most common injuries encountered in clinical routine trauma surgery. Preoperative assessment and decision making is usually based on standard 2D radiographs of the injured limb. Taking into account that a 3D - imaging modality such as computed tomography (CT) is not used for diagnosis in clinical routine, we have designed LORENZ, a fracture reduction planning tool based on such standard radiographs. Taking into account the considerable success of so-called image free navigation systems for total knee replacement in orthopaedic surgery, we assume that a similar tool for long bone fracture reposition should have considerable impact on computer-aided trauma surgery in a standard clinical routine setup. The case for long bone fracture reduction is, however, somewhat more complicated since not only scale independent angles indicating biomechanical measures such as varus and valgus are involved. Reduction path planning requires that the individual anatomy and the classification of the fracture is taken into account. In this paper, we present the basic ideas of this planning tool, it's current state, and the methodology chosen. LORENZ takes one or more conventional radiographs of the broken limb as input data. In addition, one or more x-rays of the opposite healthy bone are taken and mirrored if necessary. A most adequate CT model is being selected from a database; currently, this is achieved by using a scale space approach on the digitized x-ray images and comparing standard perspective renderings to these x-rays. After finding a CT-volume with a similar bone, a triangulated surface model is generated, and the surgeon can break the bone and arrange the fragments in 3D according to the x-ray images of the broken bone. Common osteosynthesis plates and implants can be loaded from CAD-datasets and are visualized as well. In addition, LORENZ renders virtual x-ray views of the fracture reduction process. The hybrid surface/voxel rendering engine of LORENZ also features full collision detection of fragments and implants by using the RAPID collision detection library. The reduction path is saved, and a TCP/IP interface to a robot for executing the reduction was added. LORENZ is platform independent and was programmed using Qt, AVW and OpenGL. We present a prototype for computer-aided fracture reduction planning based on standard radiographs. First test on clinical CT-Xray image pairs showed good performance; a current effort focuses on improving the speed of model retrieval by using orthonormal image moment decomposition, and on clinical evaluation for both training and surgical planning purposes. Furthermore, user-interface aspects are currently under evaluation and will be discussed.

Clostridium difficile infection in patients with inflammatory bowel disease

PubMed Central

Saidel-Odes, Lisa; Borer, Abraham; Odes, Selwyn

2011-01-01

Clostridium difficile infection in patients with inflammatory bowel disease has become a serious clinical problem over the past few years. This review is focused on the current changes in epidemiology, pertinent clinical aspects, standard and newer diagnostic methods, established and novel therapies, and prevention of infection. There is emphasis on the importance of clinical awareness, rapid detection by stool testing, and appropriate antibiotic therapy, while newer technologies, antibiotics and other treatments are explored. PMID:24713726

GMP-Grade mRNA Electroporation of Dendritic Cells for Clinical Use.

PubMed

Derdelinckx, Judith; Berneman, Zwi N; Cools, Nathalie

2016-01-01

mRNA-electroporated dendritic cells (DC) are demonstrating clinical benefit in patients in many therapeutic areas, including cancer and infectious diseases. According to current good manufacturing guidelines, cell-based medicinal products have to be defined for identity, purity, potency, stability, and viability. In order to comply with the directives and guidelines defined by the regulatory authorities, we report here a standardized and reproducible method for the manufacturing of clinical-grade mRNA-transfected DC.

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

PubMed

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.

Clinical compliance of viewing conditions in radiology reporting environments against current guidelines and standards

NASA Astrophysics Data System (ADS)

Daly, S.; Rainford, L.; Butler, M. L.

2014-03-01

Several studies have demonstrated the importance of environmental conditions in the radiology reporting environment, with many indicating that incorrect parameters could lead to error and misinterpretation. Literature is available with recommendations as to the levels that should be achieved in clinical practice, but evidence of adherence to these guidelines in radiology reporting environments is absent. This study audited the reporting environments of four teleradiologist and eight hospital based radiology reporting areas. This audit aimed to quantify adherence to guidelines and identify differences in the locations with respect to layout and design, monitor distance and angle as well as the ambient factors of the reporting environments. In line with international recommendations, an audit tool was designed to enquire in relation to the layout and design of reporting environments, monitor angle and distances used by radiologists when reporting, as well as the ambient factors such as noise, light and temperature. The review of conditions were carried out by the same independent auditor for consistency. The results obtained were compared against international standards and current research. Each radiology environment was given an overall compliance score to establish whether or not their environments were in line with recommended guidelines. Poor compliance to international recommendations and standards among radiology reporting environments was identified. Teleradiology reporting environments demonstrated greater compliance than hospital environments. The findings of this study identified a need for greater awareness of environmental and perceptual issues in the clinical setting. Further work involving a larger number of clinical centres is recommended.

Review and comparison of quality standards, guidelines and regulations for laboratories.

PubMed

Datema, Tjeerd A M; Oskam, Linda; Klatser, Paul R

2012-01-01

The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services . Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

The More the Merrier? Working Towards Multidisciplinary Management of Obstructive Sleep Apnea and Comorbid Insomnia

PubMed Central

Ong, Jason C.; Crisostomo, M. Isabel

2013-01-01

Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that is associated with negative cardiovascular consequences and adverse events from excessive daytime sleepiness. Insomnia is the inability to initiate or maintain sleep accompanied by daytime dysfunction. OSA and insomnia co-occur at a high rate, and such patients appear to have distinct clinical features of both disorders. Although empirically supported treatments are now available for OSA and insomnia independently, there are currently no standards or guidelines for how to combine or initiate these treatments for patients who suffer from both sleep disorders. Our goal was to review the literature on current diagnostic considerations, clinical features, pathophysiology, and treatment approaches for patients with OSA and comorbid insomnia. In particular, the potential benefits and challenges of using a multidisciplinary treatment model are discussed, including a research strategy that could inform implementation of pulmonary and behavioral sleep medicine treatments. The research, clinical, and policy implications of treating both OSA and insomnia are discussed with the hope that further activity will establish standards or guidelines for patients with OSA and insomnia. PMID:23382086

Verbal Memory Impairment in Polydrug Ecstasy Users: A Clinical Perspective.

PubMed

Kuypers, Kim P C; Theunissen, Eef L; van Wel, Janelle H P; de Sousa Fernandes Perna, Elizabeth B; Linssen, Anke; Sambeth, Anke; Schultz, Benjamin G; Ramaekers, Johannes G

2016-01-01

Ecstasy use has been associated with short-term and long-term memory deficits on a standard Word Learning Task (WLT). The clinical relevance of this has been debated and is currently unknown. The present study aimed at evaluating the clinical relevance of verbal memory impairment in Ecstasy users. To that end, clinical memory impairment was defined as decrement in memory performance that exceeded the cut-off value of 1.5 times the standard deviation of the average score in the healthy control sample. The primary question was whether being an Ecstasy user (E-user) was predictive of having clinically deficient memory performance compared to a healthy control group. WLT data were pooled from four experimental MDMA studies that compared memory performance during placebo and MDMA intoxication. Control data were taken from healthy volunteers with no drug use history who completed the WLT as part of a placebo-controlled clinical trial. This resulted in a sample size of 65 E-users and 65 age- and gender-matched healthy drug-naïve controls. All participants were recruited by similar means and were tested at the same testing facilities using identical standard operating procedures. Data were analyzed using linear mixed-effects models, Bayes factor, and logistic regressions. Findings were that verbal memory performance of placebo-treated E-users did not differ from that of controls, and there was substantial evidence in favor of the null hypothesis. History of use was not predictive of memory impairment. During MDMA intoxication of E-users, verbal memory was impaired. The combination of the acute and long-term findings demonstrates that, while clinically relevant memory impairment is present during intoxication, it is absent during abstinence. This suggests that use of Ecstasy/MDMA does not lead to clinically deficient memory performance in the long term. Additionally, it has to be investigated whether the current findings apply to more complex cognitive measures in diverse 'user categories' using a combination of genetics, imaging techniques and neuropsychological assessments.

Role of imaging in testicular cancer: current and future practice.

PubMed

Barrisford, Glen W; Kreydin, Evgeniy I; Preston, Mark A; Rodriguez, Dayron; Harisighani, Mukesh G; Feldman, Adam S

2015-09-01

The article provides a summary of the epidemiologic and clinical aspects of testicular malignancy. Current standard imaging and novel techniques are reviewed. Present data and clinical treatment trends have favored surveillance protocols over adjuvant radiation or chemotherapy for low-stage testicular malignancy. This has resulted in increasing numbers of imaging studies and the potential for increased long-term exposure risks. Understanding imaging associated risks as well as strategies to minimize these risks is of increasing importance. The development, validation and incorporation of alternative lower risk highly efficacious and cost-effective imaging techniques is essential.

Approaches to biofilm-associated infections: the need for standardized and relevant biofilm methods for clinical applications.

PubMed

Malone, Matthew; Goeres, Darla M; Gosbell, Iain; Vickery, Karen; Jensen, Slade; Stoodley, Paul

2017-02-01

The concept of biofilms in human health and disease is now widely accepted as cause of chronic infection. Typically, biofilms show remarkable tolerance to many forms of treatments and the host immune response. This has led to vast increase in research to identify new (and sometimes old) anti-biofilm strategies that demonstrate effectiveness against these tolerant phenotypes. Areas covered: Unfortunately, a standardized methodological approach of biofilm models has not been adopted leading to a large disparity between testing conditions. This has made it almost impossible to compare data across multiple laboratories, leaving large gaps in the evidence. Furthermore, many biofilm models testing anti-biofilm strategies aimed at the medical arena have not considered the matter of relevance to an intended application. This may explain why some in vitro models based on methodological designs that do not consider relevance to an intended application fail when applied in vivo at the clinical level. Expert commentary: This review will explore the issues that need to be considered in developing performance standards for anti-biofilm therapeutics and provide a rationale for the need to standardize models/methods that are clinically relevant. We also provide some rational as to why no standards currently exist.

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

PubMed

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

2005-08-01

With the evolving and diverse electronic medical record (EMR) systems, there appears to be an ever greater need to link EMR systems and patient accounting systems with a standardized data exchange format. To this end, the CLinical Accounting InforMation (CLAIM) data exchange standard was developed. CLAIM is subordinate to the Medical Markup Language (MML) standard, which allows the exchange of medical data among different medical institutions. CLAIM uses eXtensible Markup Language (XML) as a meta-language. The current version, 2.1, inherited the basic structure of MML 2.x and contains two modules including information related to registration, appointment, procedure and charging. CLAIM 2.1 was implemented successfully in Japan in 2001. Consequently, it was confirmed that CLAIM could be used as an effective data exchange format between EMR systems and patient accounting systems.

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement.

PubMed

Ruiz, Carlos E; Hahn, Rebecca T; Berrebi, Alain; Borer, Jeffrey S; Cutlip, Donald E; Fontana, Greg; Gerosa, Gino; Ibrahim, Reda; Jelnin, Vladimir; Jilaihawi, Hasan; Jolicoeur, E Marc; Kliger, Chad; Kronzon, Itzhak; Leipsic, Jonathon; Maisano, Francesco; Millan, Xavier; Nataf, Patrick; O'Gara, Patrick T; Pibarot, Philippe; Ramee, Stephen R; Rihal, Charanjit S; Rodes-Cabau, Josep; Sorajja, Paul; Suri, Rakesh; Swain, Julie A; Turi, Zoltan G; Tuzcu, E Murat; Weissman, Neil J; Zamorano, Jose L; Serruys, Patrick W; Leon, Martin B

2017-04-25

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted. Copyright © 2017 American College of Cardiology Foundation and European Society of Cardiology. Published by Elsevier Inc. All rights reserved.

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

PubMed

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

2015-10-01

Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.

Conflict of Interest Policies for Organizations Producing a Large Number of Clinical Practice Guidelines

PubMed Central

Norris, Susan L.; Holmer, Haley K.; Burda, Brittany U.; Ogden, Lauren A.; Fu, Rongwei

2012-01-01

Background Conflict of interest (COI) of clinical practice guideline (CPG) sponsors and authors is an important potential source of bias in CPG development. The objectives of this study were to describe the COI policies for organizations currently producing a significant number of CPGs, and to determine if these policies meet 2011 Institute of Medicine (IOM) standards. Methodology/Principal Findings We identified organizations with five or more guidelines listed in the National Guideline Clearinghouse between January 1, 2009 and November 5, 2010. We obtained the COI policy for each organization from publicly accessible sources, most often the organization's website, and compared those polices to IOM standards related to COI. 37 organizations fulfilled our inclusion criteria, of which 17 (46%) had a COI policy directly related to CPGs. These COI policies varied widely with respect to types of COI addressed, from whom disclosures were collected, monetary thresholds for disclosure, approaches to management, and updating requirements. Not one organization's policy adhered to all seven of the IOM standards that were examined, and nine organizations did not meet a single one of the standards. Conclusions/Significance COI policies among organizations producing a large number of CPGs currently do not measure up to IOM standards related to COI disclosure and management. CPG developers need to make significant improvements in these policies and their implementation in order to optimize the quality and credibility of their guidelines. PMID:22629391

Neuropsychology in Japan: history, current challenges, and future prospects.

PubMed

Sakamoto, Maiko

2016-11-01

The purpose of this special issue was to describe the cross-cultural differences in neuropsychology throughout the world. The current state of neuropsychology in Japan is discussed in this manuscript. Information on six topics, including (1) the history of Japanese neuropsychology, (2) licensure system, (3) job opportunities, (4) neuropsychological clinical services, (5) neuropsychological tests, and (6) neuropsychological research, was gathered via literature searches, official organization websites, and personal communication with clinical psychologists and other professionals in Japan. Neuropsychology reached Japan from the west in the late 1800s, a period of rapid political and social modernization. Professional associations were founded in the 1960s and 1970s and continued to grow. The need for neuropsychological assessment in Japan is growing; however, credential requirements for neuropsychologists have not yet been established. To practice clinical psychology in Japan, one must obtain a Master's degree and pass a licensure examination that is administered by a private professional foundation. Clinical psychologists often conduct neuropsychological tests; however, they have little training in neuropsychological assessment. While many western neuropsychological tests have been translated into Japanese and are used in clinical settings, the majority of translated tests have not been standardized and their psychometric properties remain poorly understood. Standardization and development of normative data in Japan is warranted. Given that needs for neuropsychological services are increasing, it is essential for clinical psychologists in Japan to improve their skills in neuropsychological evaluations. Japanese graduate schools must work to establish neuropsychology programs to educate and train clinical neuropsychologists.

Diabetes Information Technology: Designing Informatics Systems to Catalyze Change in Clinical Care

PubMed Central

Lester, William T.; Zai, Adrian H.; Chueh, Henry C.; Grant, Richard W.

2008-01-01

Current computerized reminder and decision support systems intended to improve diabetes care have had a limited effect on clinical outcomes. Increasing pressures on health care networks to meet standards of diabetes care have created an environment where information technology systems for diabetes management are often created under duress, appended to existing clinical systems, and poorly integrated into the existing workflow. After defining the components of diabetes disease management, the authors present an eight-step conceptual framework to guide the development of more effective diabetes information technology systems for translating clinical information into clinical action. PMID:19885355

Clinical application of brain imaging for the diagnosis of mood disorders: the current state of play

PubMed Central

Savitz, J B; Rauch, S L; Drevets, W C

2013-01-01

In response to queries about whether brain imaging technology has reached the point where it is useful for making a clinical diagnosis and for helping to guide treatment selection, the American Psychiatric Association (APA) has recently written a position paper on the Clinical Application of Brain Imaging in Psychiatry. The following perspective piece is based on our contribution to this APA position paper, which specifically emphasized the application of neuroimaging in mood disorders. We present an introductory overview of the challenges faced by researchers in developing valid and reliable biomarkers for psychiatric disorders, followed by a synopsis of the extant neuroimaging findings in mood disorders, and an evidence-based review of the current research on brain imaging biomarkers in adult mood disorders. Although there are a number of promising results, by the standards proposed below, we argue that there are currently no brain imaging biomarkers that are clinically useful for establishing diagnosis or predicting treatment outcome in mood disorders. PMID:23546169

Clinical application of brain imaging for the diagnosis of mood disorders: the current state of play.

PubMed

Savitz, J B; Rauch, S L; Drevets, W C

2013-05-01

In response to queries about whether brain imaging technology has reached the point where it is useful for making a clinical diagnosis and for helping to guide treatment selection, the American Psychiatric Association (APA) has recently written a position paper on the Clinical Application of Brain Imaging in Psychiatry. The following perspective piece is based on our contribution to this APA position paper, which specifically emphasized the application of neuroimaging in mood disorders. We present an introductory overview of the challenges faced by researchers in developing valid and reliable biomarkers for psychiatric disorders, followed by a synopsis of the extant neuroimaging findings in mood disorders, and an evidence-based review of the current research on brain imaging biomarkers in adult mood disorders. Although there are a number of promising results, by the standards proposed below, we argue that there are currently no brain imaging biomarkers that are clinically useful for establishing diagnosis or predicting treatment outcome in mood disorders.

Diversity of assessing circulating tumor cells (CTCs) emphasizes need for standardization: a CTC Guide to design and report trials.

PubMed

Bünger, S; Zimmermann, M; Habermann, J K

2015-09-01

Hematogenous spreading of tumor cells from primary tumors is a crucial step in the cascade to metastasis, the latter being the most limiting factor for patients' survival prognosis. Therefore, circulating tumor cells (CTCs) have become a field of intensive research. However, the process of isolation and identification of CTCs lacks standardization. This article presents an overview of 71 CTC studies reported in PUBMED since 2000 and focusing on colorectal cancer. These studies are evaluated regarding standardization of CTC isolation and identification, marker proteins used, study population and blood sample quality management, clinical performance, and quality measures. Overall, standardization of CTC assessment seems insufficient. Thus, comparability of CTC studies is hampered and results should be interpreted carefully. We here propose a standardized CTC guideline (CTC Guide) to prospectively design and report studies/trials in a harmonized form. Despite the current interstudy heterogeneity, the data indicate that CTC detection is of clinical relevance and CTCs should be considered as a surrogate prognostic marker. Many studies indicate the high potential for CTCs as prognostic markers, e.g., in colorectal cancer treatment. However, standardized, large-scale multicenter validation studies are still needed to pave the way for clinical implementation of CTC detection that could ameliorate individualized medicine regimes.

[Is the structure of surgical clinics in Germany changing? A current investigation into the structure of surgical clinics in the Federal Republic of Germany].

PubMed

Lob, G; Lob, T; Bauer, H; Niethard, F; Polonius, J; Siebert, H

2009-04-01

Medical developments have led to extensive specialization in the field of surgery. This has already been reflected for many years in altered structure and organization forms of surgical clinics. Indispensable quality standards, statutory general conditions, increasing competition in service providers and health insurance with transparency of the service procedure all intensify this trend. The aim of this investigation was, therefore, to determine how far this differentiation of service supply in the field of surgery is also reflected in the area and in surgical departments and clinics of basic and routine supply. To achieve this, all available published information on the structure and organization of surgical clinics in the Federal Republic of Germany was classified according to current departmentalization into "undivided" or general/visceral surgery facilities compared to orthopedic/trauma surgery departments.

[Undergraduate psychiatric training in Turkey].

PubMed

Cıngı Başterzi, Ayşe Devrim; Tükel, Raşit; Uluşahin, Aylin; Coşkun, Bülent; Alkın, Tunç; Murat Demet, Mehmet; Konuk, Numan; Taşdelen, Bahar

2010-01-01

The current trend in medical education is to abandon the experience-based traditional model and embrace the competency-based education model (CBE). The basic principle behind CBE is standardization. The first step in standardization is to determine what students must know, what they must accomplish, and what attitude they should display, and the establishment of educational goals. One of the goals of the Psychiatric Association of Turkey, Psychiatric Training Section is to standardize psychiatric training in Turkish medical schools. This study aimed to determine the current state of undergraduate psychiatric training in Turkish medical schools. Questionnaires were sent to the psychiatry department chairs of 41 medical schools. Data were analyzed using descriptive statistical methods. Of the 41 department chairs that were sent the questionnaire, 29 (70%) completed and returned them, of which 16 (66.7%) reported that they had already defined goals and educational objectives for their undergraduate psychiatric training programs. The Core Education Program, prepared by the Turkish Medicine and Health Education Council, was predominately used at 9 (37.5%) medical schools. Pre-clinical and clinical training schedules varied between medical schools. In all, 3 of the medical schools did not offer internships in psychiatry. The majority of chairs emphasized the importance of mood disorders (49.9%) and anxiety disorders (40%), suggesting that these disorders should be treated by general practitioners. Computer technology was commonly used for lecturing; however, utilization of interactive and skill-based teaching methods was limited. The most commonly used evaluation methods were written examination (87.5%) during preclinical training and oral examination (91.6%) during clinical training. The most important finding of this study was the lack of a standardized curriculum for psychiatric training in Turkey. Standardization of psychiatric training in Turkish medical schools must be developed.

Can cognitive assessment really discriminate early stages of Alzheimer's and behavioural variant frontotemporal dementia at initial clinical presentation?

PubMed

Reul, Sophia; Lohmann, Hubertus; Wiendl, Heinz; Duning, Thomas; Johnen, Andreas

2017-08-09

Neuropsychological testing is considered crucial for differential diagnosis of Alzheimer's disease (AD) and behavioural variant frontotemporal dementia (bvFTD). In-depth neuropsychological assessment revealed specific dysfunctions in the two dementia syndromes. However, a significant overlap of cognitive impairments exists in early disease stages. We questioned whether a standard neuropsychological assessment at initial clinical presentation can delineate patients with AD versus bvFTD. In a retrospective approach, we evaluated and compared how cognitive profiles assessed at initial clinical presentation predicted the diagnosis of later verified AD (n = 43) and bvFTD (n = 26). Additionally, the neuropsychological standard domains memory, language, visuospatial skills, executive functions, praxis and social cognition were subjected to stepwise discriminant analysis to compare their differential contribution to diagnosis. Regardless of diagnosis, a percentage of patients presented with major deterioration in a wide range of cognitive domains when compared with age-matched normative data. Only few significant differences were detected on the group level: Patients with AD were relatively more impaired in the verbal recall, verbal recognition, figure copy, and surprisingly in the executive subdomains, set shifting and processing speed whereas bvFTD was characterised by more deficits in imitation of face postures. A combination of tests for verbal recall, imitation of limb and face postures, and figure copy showed the greatest discriminatory power. Our results imply that the contribution of a standard neuropsychological assessment is limited for differential diagnosis of AD and bvFTD at initial presentation. In contrast to current clinical guidelines, executive functions are neither particularly nor exclusively impaired in patients with bvFTD when assessed within a standard clinical neuropsychological test battery. The significant overlap of bvFTD and AD concerning the profile of cognitive impairments questions current neuropsychological diagnostic criteria and calls for revision, regarding both the degree and the profile of cognitive deficits.

The Safety of Available Immunotherapy for the Treatment of Glioblastoma

PubMed Central

Farber, S. Harrison; Elsamadicy, Aladine A.; Atik, Fatih; Suryadevara, Carter M.; Chongsathidkiet, Pakawat; Fecci, Peter E.; Sampson, John H.

2017-01-01

Introduction Glioblastoma (GBM) is the most common malignant primary brain tumor in adults. Current standard of care involves maximal surgical resection combined with adjuvant chemoradiation. Growing support exists for a role of immunotherapy in treating these tumors with the goal of targeted cytotoxicity. Here we review data on the safety for current immunotherapies being tested in GBM. Areas covered Safety data from published clinical trials, including ongoing clinical trials were reviewed. Immunotherapeutic classes currently under investigation in GBM include various vaccination strategies, adoptive T cell immunotherapy, immune checkpoint blockade, monoclonal antibodies, and cytokine therapies. Trials include children, adolescents, and adults with either primary or recurrent GBM. Expert commentary Based on the reviewed clinical trials, the current immunotherapies targeting GBM are safe and well-tolerated with minimal toxicities which should be noted. However, the gains in patient survival have been modest. A safe and well-tolerated combinatory immunotherapeutic approach may be essential for optimal efficacy towards GBM. PMID:27989218

Efficacy vs. effectiveness research in psychotherapy: implications for clinical hypnosis.

PubMed

Amundson, Jon K; Alladin, Assen; Eamon, Gill

2003-07-01

Empirically supported therapy (EST) has become a major focus and trend for mental health practice. When hypnosis is involved, this may mean satisfying a standard that is entirely too narrow in its emphasis. In this article "efficacy"-based research in clinical practice is contrasted with "effectiveness" -focused research, and they are discussed from the perspective of hypnosis. When clinicians can consider trans-theoretical factors as well as those that are treatment-enhancing, possibilities for improved treatment outcome increase. The "effectiveness" perspective also serves as a counter point for hypnosis in contrast with the dubious efficacy-based gold standard currently proposed for therapy in general, and hypnosis in particular.

Evolution of a Patient Information Management System in a Local Area Network Environment at Loyola University of Chicago Medical Center

PubMed Central

Price, Ronald N; Chandrasekhar, Arcot J; Tamirisa, Balaji

1990-01-01

The Department of Medicine at Loyola University Medical Center (LUMC) of Chicago has implemented a local area network (LAN) based Patient Information Management System (PIMS) as part of its integrated departmental database management system. PIMS consists of related database applications encompassing demographic information, current medications, problem lists, clinical data, prior events, and on-line procedure results. Integration into the existing departmental database system permits PIMS to capture and manipulate data in other departmental applications. Standardization of clinical data is accomplished through three data tables that verify diagnosis codes, procedures codes and a standardized set of clinical data elements. The modularity of the system, coupled with standardized data formats, allowed the development of a Patient Information Protocol System (PIPS). PIPS, a userdefinable protocol processor, provides physicians with individualized data entry or review screens customized for their specific research protocols or practice habits. Physician feedback indicates that the PIMS/PIPS combination enhances their ability to collect and review specific patient information by filtering large amount of clinical data.

When the value of gold is zero.

PubMed

Chase, J Geoffrey; Moeller, Knut; Shaw, Geoffrey M; Schranz, Christoph; Chiew, Yeong Shiong; Desaive, Thomas

2014-06-27

This manuscript presents the concerns around the increasingly common problem of not having readily available or useful "gold standard" measurements. This issue is particularly important in critical care where many measurements used in decision making are surrogates of what we would truly wish to use. However, the question is broad, important and applicable in many other areas.In particular, a gold standard measurement often exists, but is not clinically (or ethically in some cases) feasible. The question is how does one even begin to develop new measurements or surrogates if one has no gold standard to compare with?We raise this issue concisely with a specific example from mechanical ventilation, a core bread and butter therapy in critical care that is also a leading cause of length of stay and cost of care. Our proposed solution centers around a hierarchical validation approach that we believe would ameliorate ethics issues around radiation exposure that make current gold standard measures clinically infeasible, and thus provide a pathway to create a (new) gold standard.

Photodynamic application in neurosurgery: present and future

NASA Astrophysics Data System (ADS)

Kostron, Herwig

2009-06-01

Photodynamic techniques such as photodynamic diagnosis (PDD), fluorescence guided tumor resection (FGR) and photodynamic therapy (PDT) are currently undergoing intensive clinical investigations as adjunctive treatment for malignant brain tumours. This review provides an overview on the current clinical data and trials as well as on photosensitisers, technical developments and indications for photodynamic application in Neurosurgery. Furthermore new developments and clinical significance of FGR for neurosurgery will be discussed. Over 1000 patients were enrolled in various clinical phase I/II trials for PDT for malignant brain tumours. Despite various treatment protocols, variation of photosensitisers and light dose there is a clear trend towards prolonging median survival after one single PDT as compared to conventional therapeutic modalities. The median survival after PDT for primary glioblastoma multiforme WHO IV was 19 months and for recurrent GBM 9 months as compared to standard convential treatment which is 15 months and 3 months, respectively. FGR in combination with adjunctive radiation was significantly superior to standard surgical resection followed by radiation. The combination of FGR/PDD and intraoperative PDT increased significantly survival in recurrent glioblastoma patients. The combination of PDD/ FGR and PDT offers an exciting approach to the treatment of malignant brain tumours "to see and to treat." PDT was generally well tolerated and side effects consisted of occasionally increased intracranial pressure and prolonged skin sensitivity against direct sunlight. This review covers the current available data and draws the future potential of PDD and PDT for its application in neurosurgery.

A booklet on participants' rights to improve consent for clinical research: a randomized trial.

PubMed

Benatar, Jocelyne R; Mortimer, John; Stretton, Matthew; Stewart, Ralph A H

2012-01-01

Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials.

A Booklet on Participants’ Rights to Improve Consent for Clinical Research: A Randomized Trial

PubMed Central

Benatar, Jocelyne R.; Mortimer, John; Stretton, Matthew; Stewart, Ralph A. H.

2012-01-01

Objective Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. Methods 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants’ rights. A booklet designed to provide information on participants’ rights which used simple language was developed to replace this information in current ICF’s Readability of each component of ICF’s and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant’s rights was assessed by questionnaire. Results Information related to participants’ rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). Conclusions A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials. PMID:23094034

Current concepts of severe asthma

PubMed Central

Raundhal, Mahesh; Oriss, Timothy B.; Ray, Prabir; Wenzel, Sally E.

2016-01-01

The term asthma encompasses a disease spectrum with mild to very severe disease phenotypes whose traditional common characteristic is reversible airflow limitation. Unlike milder disease, severe asthma is poorly controlled by the current standard of care. Ongoing studies using advanced molecular and immunological tools along with improved clinical classification show that severe asthma does not identify a specific patient phenotype, but rather includes patients with constant medical needs, whose pathobiologic and clinical characteristics vary widely. Accordingly, in recent clinical trials, therapies guided by specific patient characteristics have had better outcomes than previous therapies directed to any subject with a diagnosis of severe asthma. However, there are still significant gaps in our understanding of the full scope of this disease that hinder the development of effective treatments for all severe asthmatics. In this Review, we discuss our current state of knowledge regarding severe asthma, highlighting different molecular and immunological pathways that can be targeted for future therapeutic development. PMID:27367183

Electronic Health Records Data and Metadata: Challenges for Big Data in the United States.

PubMed

Sweet, Lauren E; Moulaison, Heather Lea

2013-12-01

This article, written by researchers studying metadata and standards, represents a fresh perspective on the challenges of electronic health records (EHRs) and serves as a primer for big data researchers new to health-related issues. Primarily, we argue for the importance of the systematic adoption of standards in EHR data and metadata as a way of promoting big data research and benefiting patients. EHRs have the potential to include a vast amount of longitudinal health data, and metadata provides the formal structures to govern that data. In the United States, electronic medical records (EMRs) are part of the larger EHR. EHR data is submitted by a variety of clinical data providers and potentially by the patients themselves. Because data input practices are not necessarily standardized, and because of the multiplicity of current standards, basic interoperability in EHRs is hindered. Some of the issues with EHR interoperability stem from the complexities of the data they include, which can be both structured and unstructured. A number of controlled vocabularies are available to data providers. The continuity of care document standard will provide interoperability in the United States between the EMR and the larger EHR, potentially making data input by providers directly available to other providers. The data involved is nonetheless messy. In particular, the use of competing vocabularies such as the Systematized Nomenclature of Medicine-Clinical Terms, MEDCIN, and locally created vocabularies inhibits large-scale interoperability for structured portions of the records, and unstructured portions, although potentially not machine readable, remain essential. Once EMRs for patients are brought together as EHRs, the EHRs must be managed and stored. Adequate documentation should be created and maintained to assure the secure and accurate use of EHR data. There are currently a few notable international standards initiatives for EHRs. Organizations such as Health Level Seven International and Clinical Data Interchange Standards Consortium are developing and overseeing implementation of interoperability standards. Denmark and Singapore are two countries that have successfully implemented national EHR systems. Future work in electronic health information initiatives should underscore the importance of standards and reinforce interoperability of EHRs for big data research and for the sake of patients.

Clinical performance of a new blood control peripheral intravenous catheter: A prospective, randomized, controlled study.

PubMed

Seiberlich, Laura E; Keay, Vanessa; Kallos, Stephane; Junghans, Tiffany; Lang, Eddy; McRae, Andrew D

2016-03-01

The performance of a new safety peripheral intravenous catheter (PIVC) that contains a blood control feature in the hub (blood control) was compared against the current hospital standard without blood control (standard). In this prospective, non-blinded trial, patients were randomized 1:1 to receive either device. Insertions were performed and rated by emergency room nurses. Primary endpoints included clinical acceptability, incidence of blood leakage, and risk of blood exposure. Secondary endpoints were digital compression, insertion success, and usability. 15 clinicians performed 152 PIVC insertions (73 blood control, 79 standard). Clinical acceptability of the blood control device (100%) was non-inferior to the standard (98.7%) (p < 0.0001). The blood control device had a lower incidence of blood leakage (14.1% vs 68.4%), was superior in eliminating the risk of blood exposure (93.9% vs 19.1%) and the need for digital compression (95.3% vs 19.1%), while maintaining non-inferior insertion success rates (95.9% vs 93.7%) and usability ratings (p < 0.0001). In comparison with the hospital-standard, the new safety PIVC with integrated blood control valve had similar clinical acceptability ratings yet demonstrated superior advantages to both clinicians and patients to decrease blood leakage and the clinician's risk of blood exposure, during the insertion process. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Clinical interpretation of antinuclear antibody tests in systemic rheumatic diseases

PubMed Central

Mercado, Monica Vázquez-Del; Chan, Edward K. L.

2010-01-01

Autoantibody tests have been used extensively in diagnosis and follow-up of patients in rheumatology clinics. Immunofluorescent antinuclear antibody test using HEp-2 cells is still considered the gold standard for screening of autoantibodies, and most of specific autoantibodies are currently tested by ELISA as a next step. Among the many autoantibody specificities described, some have been established as clinically useful diagnostic markers and are included in the classification criteria of diseases. Despite a long history of routine tests and attempts to standardize such assays, there are still limitations and problems that clinicians need to be aware of. Clinicians should be able to use autoantibody tests more efficiently and effectively with a basic knowledge on the significance of and potential problems in autoantibody tests. PMID:19277826

The structured menstrual history: developing a tool to facilitate diagnosis and aid in symptom management.

PubMed

Matteson, Kristen A; Munro, Malcolm G; Fraser, Ian S

2011-09-01

Abnormal uterine bleeding (AUB) is a prevalent symptom that encompasses abnormalities in menstrual regularity, duration, frequency and/or volume, and it is encountered frequently by both primary care physicians and obstetrician-gynecologists. Research on AUB has used numerous methods to measure bleeding and assess symptoms, but the lack of universally accepted outcome measures hinder the quality of research and the ability of clinical investigators to collaborate in multicenter trials. Similarly, clinical care for women reporting heavy, prolonged, or irregular menstrual bleeding is not optimized because standard ways of evaluating symptoms and change in symptoms over time do not exist. This article describes (1) the current methods of evaluating women with AUB, both in research and clinical care; and (2) offers suggestions for the development of a standardized structured menstrual history for use in both research and clinical care. © Thieme Medical Publishers.

Cross-mapping clinical notes between hospitals: an application of the LOINC Document Ontology.

PubMed

Li, Li; Morrey, C Paul; Baorto, David

2011-01-01

Standardization of document titles is essential for management as the volume of electronic clinical notes increases. The two campuses of the New York Presbyterian Hospital have over 2,700 distinct document titles. The LOINC Document Ontology (DO) provides a standard for the naming of clinical documents in a multi-axis structure. We have represented the latest LOINC DO structure in the MED, and developed an automated process mapping the clinical documents from both the West (Columbia) and East (Cornell) campuses to the LOINC DO. We find that the LOINC DO can represent the majority of our documents, and about half of the documents map between campuses using the LOINC DO as a reference. We evaluated the possibility of using current LOINC codes in document exchange between different institutions. While there is clear success in the ability of the LOINC DO to represent documents and facilitate exchange we find there are granularity issues.

Novel methods to optimize the effects of transcranial direct current stimulation: a systematic review of transcranial direct current stimulation patents.

PubMed

Malavera, Alejandra; Vasquez, Alejandra; Fregni, Felipe

2015-01-01

Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that has been extensively studied. While there have been initial positive results in some clinical trials, there is still variability in tDCS results. The aim of this article is to review and discuss patents assessing novel methods to optimize the use of tDCS. A systematic review was performed using Google patents database with tDCS as the main technique, with patents filling date between 2010 and 2015. Twenty-two patents met our inclusion criteria. These patents attempt to address current tDCS limitations. Only a few of them have been investigated in clinical trials (i.e., high-definition tDCS), and indeed most of them have not been tested before in human trials. Further clinical testing is required to assess which patents are more likely to optimize the effects of tDCS. We discuss the potential optimization of tDCS based on these patents and the current experience with standard tDCS.

[Review of current classification and terminology of vulvar disorders].

PubMed

Sláma, J

2012-08-01

To summarize current terminology and classification of vulvar disorders. Review article. Gynecologic oncology center, Department of Gynecology and Obstetrics, General Faculty Hospital and 1st Medical School of Charles University, Prague. Vulvar disorders include wide spectrum of different diagnoses. Multidisciplinary collaboration is frequently needed in diagnostical and therapeutical process. It is essential to use unified terminology using standard dermatological terms, and unified classification for comprehensible communication between different medical professions. Current classification, which is based on Clinical-pathological criteria, was established by International Society for the Study of Vulvovaginal Disease. Recently, there was introduced Clinical classification, which groups disorders according to main morphological finding. Adequate and unified classification and terminology are necessary for effective communication during the diagnostical process.

Perception survey on the introduction of clinical performance examination as part of the national nursing licensing examination in Korea.

PubMed

Shin, Su Jin; Kim, Yeong Kyeong; Suh, Soon-Rim; Jung, Duk Yoo; Kim, Yunju; Yim, Mi Kyoung

2017-01-01

The purpose of this study was to analyze opinions about the action plan for implementation of clinical performance exam as part of the national nursing licensing examination and presents the expected effects of the performance exam and aspects to consider regarding its implementation. This study used a mixed-methods design. Quantitative data were collected by a questionnaire survey, while qualitative data were collected by focus group interviews with experts. The survey targeted 200 nursing professors and clinical nurses with more than 5 years of work experience, and the focus group interviews were conducted with 28 of professors, clinical instructors, and nurses at hospitals. First, nursing professors and clinical specialists agreed that the current written tests have limitations in evaluating examinees' ability, and that the introduction of a clinical performance exam will yield positive results. Clinical performance exam is necessary to evaluate and improve nurses' work ability, which means that the implementation of a performance exam is advisable if its credibility and validity can be verified. Second, most respondents chose direct performance exams using simulators or standardized patients as the most suitable format of the test. In conclusion, the current national nursing licensing exam is somewhat limited in its ability to identify competent nurses. Thus, the time has come for us to seriously consider the introduction of a performance exam. The prerequisites for successfully implementing clinical performance exam as part of the national nursing licensing exam are a professional training process and forming a consortium to standardize practical training.

Perception survey on the introduction of clinical performance examination as part of the national nursing licensing examination in Korea

PubMed Central

2017-01-01

Purpose The purpose of this study was to analyze opinions about the action plan for implementation of clinical performance exam as part of the national nursing licensing examination and presents the expected effects of the performance exam and aspects to consider regarding its implementation. Methods This study used a mixed-methods design. Quantitative data were collected by a questionnaire survey, while qualitative data were collected by focus group interviews with experts. The survey targeted 200 nursing professors and clinical nurses with more than 5 years of work experience, and the focus group interviews were conducted with 28 of professors, clinical instructors, and nurses at hospitals. Results First, nursing professors and clinical specialists agreed that the current written tests have limitations in evaluating examinees’ ability, and that the introduction of a clinical performance exam will yield positive results. Clinical performance exam is necessary to evaluate and improve nurses’ work ability, which means that the implementation of a performance exam is advisable if its credibility and validity can be verified. Second, most respondents chose direct performance exams using simulators or standardized patients as the most suitable format of the test. Conclusion In conclusion, the current national nursing licensing exam is somewhat limited in its ability to identify competent nurses. Thus, the time has come for us to seriously consider the introduction of a performance exam. The prerequisites for successfully implementing clinical performance exam as part of the national nursing licensing exam are a professional training process and forming a consortium to standardize practical training. PMID:29129904

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership

PubMed Central

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Abstract Objective Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. Methods A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Results Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. Conclusion A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. PMID:29069424

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership.

PubMed

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Better infrastructure for critical care trials: nomenclature, etymology, and informatics.

PubMed

Singh, Jeffrey M; Ferguson, Niall D

2009-01-01

The goals of this review article are to review the importance and value of standardized definitions in clinical research, as well as to propose the necessary tools and infrastructure needed to advance nosology and medial taxonomy to improve the quality of clinical trials in the field of critical care. We searched MEDLINE for relevant articles, reviewed those selected and their reference lists, and consulted personal files for relevant information. When the pathobiology of diseases is well understood, standard disease definitions can be extremely specific and precise; however, when the pathobiology of the disease is less well understood or more complex, biological markers may not be diagnostically useful or even available. In these cases, syndromic definitions effectively classify and group illnesses with similar symptoms and clinical signs. There is no clear gold standard for the diagnosis of many clinical entities in the intensive care unit, including notably both acute respiratory distress syndrome and sepsis. There are several types of consensus methods that can be used to explicate the judgmental approach that is often needed in these cases, including interactive or consensus groups, the nominal group technique, and the Delphi technique. Ideally, the definition development process will create clear and unambiguous language in which each definition accurately reflects the current understanding of the disease state. The development, implementation, evaluation, revision, and reevaluation of standardized definitions are keys for advancing the quality of clinical trials in the critical care arena.

Validity of the WISC-IV Spanish for a clinically referred sample of Hispanic children.

PubMed

San Miguel Montes, Liza E; Allen, Daniel N; Puente, Antonio E; Neblina, Cris

2010-06-01

The Wechsler Intelligence Scale for Children (WISC) is the most commonly used intelligence test for children. Five years ago, a Spanish version of the WISC-IV was published (WISC-IV Spanish; Wechsler, 2005), but a limited amount of published information is available regarding its utility when assessing clinical samples. The current study included 107 children who were Spanish speaking and of Puerto Rican descent that had been administered the WISC-IV Spanish. They were subdivided into a clinical sample of 35 children with diagnoses of various forms of brain dysfunction (primarily learning disability, attention-deficit/hyperactivity disorder, and epilepsy) and a comparison group made up of 72 normal children who were part of the WISC-IV Spanish version standardization sample. Comparisons between these groups and the standardization sample were performed for the WISC-IV Spanish index and subtest scores. Results indicated that the clinical sample performed worse than the comparison samples on the Working Memory and Processing Speed Indexes, although findings varied to some extent depending on whether the clinical group was compared with the normal comparison group or the standardization sample. These findings provide support for the criterion validity of the WISC-IV Spanish when it is used to assess a clinically referred sample with brain dysfunction.

Evidence and resources to implement Pharmacogenetic Knowledge for Precision Medicine

PubMed Central

Caudle, Kelly E.; Gammal, Roseann S.; Whirl-Carrillo, Michelle; Hoffman, James M.; Relling, Mary V.; Klein, Teri E.

2016-01-01

Purpose Implementation of pharmacogenetics into clinical practice has been relatively slow despite substantial scientific progress over the last decade. One barrier that inhibits uptake of pharmacogenetics into routine clinical practice is the lack of knowledge of how to translate a genetic test into a clinical action based on current evidence. The purpose of this paper is to describe the current state of pharmacogenetic evidence and evidence-based resources that facilitate the uptake of pharmacogenetics into clinical practice. Summary Controversy exists over the required evidence threshold needed for routine clinical implementation of pharmacogenetics. Large randomized controlled trials are not clinically feasible or necessary for many pharmacogenetic applications. Online resources exist like the Clinical Pharmacogenetics Implementation Consortium (CPIC) and the Pharmacogenomics Knowledgebase (PharmGKB) that provide freely available, evidence-based resources that facilitate the translation of genetic laboratory test results into actionable prescribing recommendations for specific drugs. Conclusion Resources provided by organizations such as CPIC and PharmGKB that use standardized approaches to evaluate the literature and provide clinical guidance are essential for the implementation of pharmacogenetics into routine clinical practice. PMID:27864205

Nephron segment specific microRNA biomarkers of pre-clinical drug-induced renal toxicity: Opportunities and challenges

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nassirpour, Rounak, E-mail: Rounak.nassirpour@pfiz

Drug-induced nephrotoxicity is a common drug development complication for pharmaceutical companies. Sensitive, specific, translatable and non-invasive biomarkers of renal toxicity are urgently needed to diagnose nephron segment specific injury. The currently available gold standard biomarkers for nephrotoxicity are not kidney-specific, lack sensitivity for early detection, and are not suitable for renal damage localization (glomerular vs tubulointerstitial injury). MicroRNAs (miRNAs) are increasingly gaining momentum as promising biomarkers of various organ toxicities, including drug induced renal injury. This is mostly due to their stability in easily accessible biofluids, ease of developing nucleic acids detection compared to protein detection assays, as well asmore » their interspecies translatability. Increasing concordance of miRNA findings by standardizing methodology most suitable for their detection and quantitation, as well as characterization of their expression pattern in a cell type specific manner, will accelerate progress toward validation of these miRNAs as biomarkers in pre-clinical, and clinical settings. This review aims to highlight the current pre-clinical findings surrounding miRNAs as biomarkers in two important segments of the nephron, the glomerulus and tubules. - Highlights: • miRNAs are promising biomarkers of drug-induced kidney injury. • Summarized pre-clinical miRNA biomarkers of drug-induced nephrotoxicity. • Described the strengths and challenges associated with miRNAs as biomarkers.« less

[Comparison and review on specifications of fermented Cordyceps sinensis products].

PubMed

Yang, Ping; Zhao, Xiao-Xia; Zhang, Yong-Wen

2018-02-01

There are five kinds of fermented Cordyceps crude drug and their preparations that have been approved as medicine on the market. Since the initial strains of the crude drug were all isolated from natural Cordyceps sinensis， they have similar names， chemical components and even clinical applications. However， because of the different strain species and fermentation processes， there was significant difference in quality. As a result， they should be clearly distinguished in clinical use. Most of the products were researched and developed during the 1980s and 1990s， so there was difference in quality standards for different products， and their quality control levels of some products were not perfect. At present， some of the products are approved as Chinese medicine， others are approved as chemical drugs， with a confusion in products name， management and clinical application. In this paper， the approval numbers， quality standards and clinical applications， and current problems of these products were summarized and compared; some suggestions were put forward， such as standardizing the product name， unifying the management of approval number category， and increasing the specific quality control attributes， in order to provide reference for standard implementation， quality control and drug regulation for fermented Cordyceps crude drugs and their preparations. Copyright© by the Chinese Pharmaceutical Association.

XML syntax for clinical laboratory procedure manuals.

PubMed

Saadawi, Gilan; Harrison, James H

2003-01-01

We have developed a document type description (DTD) in Extensable Markup Language (XML) for clinical laboratory procedures. Our XML syntax can adequately structure a variety of procedure types across different laboratories and is compatible with current procedure standards. The combination of this format with an XML content management system and appropriate style sheets will allow efficient procedure maintenance, distributed access, customized display and effective searching across a large body of test information.

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

PubMed Central

2013-01-01

Background 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. Methods 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). Results 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-nine percent of respondents wanted to improve their assessments, identifying individual, environmental and measure-specific barriers. The most common barriers were lack of time and knowledge. Conclusions This study offers new information on issues affecting the evaluation of balance in clinical settings from a broad sample of physiotherapists. Continued work to address barriers by specific practice area will be critical for the success of any intervention attempting to implement optimal balance assessment practices in the clinical setting. PMID:23510277

Genetic Testing as a New Standard for Clinical Diagnosis of Color Vision Deficiencies.

PubMed

Davidoff, Candice; Neitz, Maureen; Neitz, Jay

2016-09-01

The genetics underlying inherited color vision deficiencies is well understood: causative mutations change the copy number or sequence of the long (L), middle (M), or short (S) wavelength sensitive cone opsin genes. This study evaluated the potential of opsin gene analyses for use in clinical diagnosis of color vision defects. We tested 1872 human subjects using direct sequencing of opsin genes and a novel genetic assay that characterizes single nucleotide polymorphisms (SNPs) using the MassArray system. Of the subjects, 1074 also were given standard psychophysical color vision tests for a direct comparison with current clinical methods. Protan and deutan deficiencies were classified correctly in all subjects identified by MassArray as having red-green defects. Estimates of defect severity based on SNPs that control photopigment spectral tuning correlated with estimates derived from Nagel anomaloscopy. The MassArray assay provides genetic information that can be useful in the diagnosis of inherited color vision deficiency including presence versus absence, type, and severity, and it provides information to patients about the underlying pathobiology of their disease. The MassArray assay provides a method that directly analyzes the molecular substrates of color vision that could be used in combination with, or as an alternative to current clinical diagnosis of color defects.

Genetic Testing as a New Standard for Clinical Diagnosis of Color Vision Deficiencies

PubMed Central

Davidoff, Candice; Neitz, Maureen; Neitz, Jay

2016-01-01

Purpose The genetics underlying inherited color vision deficiencies is well understood: causative mutations change the copy number or sequence of the long (L), middle (M), or short (S) wavelength sensitive cone opsin genes. This study evaluated the potential of opsin gene analyses for use in clinical diagnosis of color vision defects. Methods We tested 1872 human subjects using direct sequencing of opsin genes and a novel genetic assay that characterizes single nucleotide polymorphisms (SNPs) using the MassArray system. Of the subjects, 1074 also were given standard psychophysical color vision tests for a direct comparison with current clinical methods. Results Protan and deutan deficiencies were classified correctly in all subjects identified by MassArray as having red–green defects. Estimates of defect severity based on SNPs that control photopigment spectral tuning correlated with estimates derived from Nagel anomaloscopy. Conclusions The MassArray assay provides genetic information that can be useful in the diagnosis of inherited color vision deficiency including presence versus absence, type, and severity, and it provides information to patients about the underlying pathobiology of their disease. Translational Relevance The MassArray assay provides a method that directly analyzes the molecular substrates of color vision that could be used in combination with, or as an alternative to current clinical diagnosis of color defects. PMID:27622081

Lung function imaging methods in Cystic Fibrosis pulmonary disease.

PubMed

Kołodziej, Magdalena; de Veer, Michael J; Cholewa, Marian; Egan, Gary F; Thompson, Bruce R

2017-05-17

Monitoring of pulmonary physiology is fundamental to the clinical management of patients with Cystic Fibrosis. The current standard clinical practise uses spirometry to assess lung function which delivers a clinically relevant functional readout of total lung function, however does not supply any visible or localised information. High Resolution Computed Tomography (HRCT) is a well-established current 'gold standard' method for monitoring lung anatomical changes in Cystic Fibrosis patients. HRCT provides excellent morphological information, however, the X-ray radiation dose can become significant if multiple scans are required to monitor chronic diseases such as cystic fibrosis. X-ray phase-contrast imaging is another emerging X-ray based methodology for Cystic Fibrosis lung assessment which provides dynamic morphological and functional information, albeit with even higher X-ray doses than HRCT. Magnetic Resonance Imaging (MRI) is a non-ionising radiation imaging method that is garnering growing interest among researchers and clinicians working with Cystic Fibrosis patients. Recent advances in MRI have opened up the possibilities to observe lung function in real time to potentially allow sensitive and accurate assessment of disease progression. The use of hyperpolarized gas or non-contrast enhanced MRI can be tailored to clinical needs. While MRI offers significant promise it still suffers from poor spatial resolution and the development of an objective scoring system especially for ventilation assessment.

Fracture healing: A review of clinical, imaging and laboratory diagnostic options.

PubMed

Cunningham, Brian P; Brazina, Sloane; Morshed, Saam; Miclau, Theodore

2017-06-01

A fundamental issue in clinical orthopaedics is the determination of when a fracture is united. However, there are no established "gold standards," nor standardized methods for assessing union, which has resulted in significant disagreement among orthopaedic surgeons in both clinical practice and research. A great deal of investigative work has been directed to addressing this problem, with a number of exciting new techniques described. This review provides a brief summary of the burden of nonunion fractures and addresses some of the challenges related to the assessment of fracture healing. The tools currently available to determine union are discussed, including various imaging modalities, biomechanical testing methods, and laboratory and clinical assessments. The evaluation of fracture healing in the setting of both patient care and clinical research is integral to the orthopaedic practice. Weighted integration of several available metrics must be considered to create a composite outcome measure of patient prognosis. Copyright © 2017 Elsevier Ltd. All rights reserved.

Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies

PubMed Central

Grangeot-Keros, Liliane; Vauloup-Fellous, Christelle

2015-01-01

SUMMARY Rubella virus usually causes a mild infection in humans but can cause congenital rubella syndrome (CRS). Vaccination programs have significantly decreased primary rubella virus infection and CRS; however, vaccinated individuals usually have lower levels of rubella virus IgG than those with natural infections. Rubella virus IgG is quantified with enzyme immunoassays that have been calibrated against the World Health Organization (WHO) international standard and report results in international units per milliliter. It is recognized that the results reported by these assays are not standardized. This investigation into the reasons for the lack of standardization found that the current WHO international standard (RUB-1-94) fails by three key metrological principles. The standard is not a pure analyte but is composed of pooled human immunoglobulin. It was not calibrated by certified reference methods; rather, superseded tests were used. Finally, no measurement uncertainty estimations have been provided. There is an analytical and clinical consequence to the lack of standardization of rubella virus IgG assays, which leads to misinterpretation of results. The current approach to standardization of rubella virus IgG assays has not achieved the desired results. A new approach is required. PMID:26607813

Preventing Epilepsy After Traumatic Brain Injury

DTIC Science & Technology

2008-02-01

early seizures to the standard of care ( phenytoin ). A secondary objective is to obtain the data necessary to design a randomized clinical trial to...protocol was revised to eliminate several major obstacles. We have enrolled 5 subjects into the study; two in the phenytoin arm, one in the short term...prevent early seizures better than the current standard of care ( phenytoin ). A secondary objective is to obtain the data necessary to design a randomized

National Bone Health Alliance Bone Turnover Marker Project: current practices and the need for US harmonization, standardization, and common reference ranges.

PubMed

Bauer, D; Krege, J; Lane, N; Leary, E; Libanati, C; Miller, P; Myers, G; Silverman, S; Vesper, H W; Lee, D; Payette, M; Randall, S

2012-10-01

This position paper reviews how the National Bone Health Alliance (NBHA) will execute a project to help assure health professionals of the clinical utility of bone turnover markers; the current clinical approaches concerning osteoporosis and the status and use of bone turnover markers in the USA; the rationale for focusing this effort around two specific bone turnover markers; the need to standardize bone marker sample collection procedures, reference ranges, and bone turnover marker assays in clinical laboratories; and the importance of harmonization for future research of bone turnover markers. Osteoporosis is a major global health problem, with the prevalence and incidence of osteoporosis for at-risk populations estimated to be 44 million Americans. The potential of bone markers as an additional tool for health care professionals to improve patient outcomes and impact morbidity and mortality is crucial in providing better health care and addressing rising health care costs. This need to advance the field of bone turnover markers has been recognized by a number of organizations, including the International Osteoporosis Foundation (IOF), National Osteoporosis Foundation, International Federation of Clinical Chemistry, and Laboratory Medicine (IFCC), and the NBHA. This position paper elucidates how this project will standardize bone turnover marker sample collection procedures in the USA, establish a USA reference range for one bone formation (serum procollagen type I N propeptide, s-PINP) and one bone resorption (serum C-terminal telopeptide of type I collagen, s-CTX) marker, and standardize bone turnover marker assays used in clinical laboratories. This effort will allow clinicians from the USA to have confidence in their use of bone turnover markers to help monitor osteoporosis treatment and assess future fracture risk. This project builds on the recommendations of the IOF/IFCC Bone Marker Standards Working Group by developing USA reference standards for s-PINP and s-CTX, the markers identified as most promising for use as reference markers. The goals of this project will be realized through the NBHA and will include its governmental, academic, for-profit, and non-profit sector stakeholders as well as major academic and commercial laboratories. Upon completion, a parallel effort will be pursued to make bone turnover marker measurements reliable and accepted by all health care professionals for facilitating treatment decisions and ultimately be reimbursed by all health insurance payers. Successful completion of this project will help assure health professionals from the USA of the clinical utility of bone turnover markers and ties in with the parallel effort of the IOF/IFCC to develop worldwide bone turnover reference ranges.

Novel femoral artery terminology: integrating anatomy and clinical procedures leading to standardized intuitive nomenclature.

PubMed

Benninger, Brion

2014-10-01

The objective of this study is to investigate the terminology of the femoral artery and recommended alternative terminology that satisfies both anatomy and clinical arenas.The femoral artery (FA) is often defined as the continuation of the external iliac artery. Specifically, when the external iliac artery reaches directly beneath the inguinal ligament, it becomes the FA. Currently, Terminologia Anatomica (TA) records the profunda femoris or deep femoral as a terminal branch. Clinicians often use superficial femoral artery (SFA) rather than FA and profunda or deep FA. SFA is actually very deep and well protected for most of its journey. On observation, the terminology in current use is not intuitive. The objective of this study was to investigate the terminology associated with the anatomical and clinical anatomical interpretations of the FA and its terminal branches and to suggest a more appropriate terminology that addresses the points of view of the macro anatomist, as well as that of the clinician. Literature search was conducted regarding the nomenclature of the FA and its terminal branches. Dissection of 89 embalmed cadavers (49F, 40M, ages 47-89) was conducted to analyze the morphology of the FA and its branches. Perusal of the literature revealed a difference in terminology between anatomical and clinical textbooks/atlases/journals regarding the FA and its terminal branch. Our dissections suggested that the FA may be better defined vis-à-vis its relationship to the anterior and posterior compartments of the thigh. A difference in terminology exists between the anatomical and clinical arenas. A need for a standardized terminology is necessary because clinicians and their publishers have not adopted TA. This study suggests that the current FA be considered the common FA and the continuation of the FA, the SFA be renamed the anterior FA and the current profunda (the deep FA) be renamed the posterior FA, respectively. The proposed terminology mirrors the lower limb anterior/posterior tibial artery terminology. © 2014 Wiley Periodicals, Inc.

Microfluidic Transduction Harnesses Mass Transport Principles to Enhance Gene Transfer Efficiency.

PubMed

Tran, Reginald; Myers, David R; Denning, Gabriela; Shields, Jordan E; Lytle, Allison M; Alrowais, Hommood; Qiu, Yongzhi; Sakurai, Yumiko; Li, William C; Brand, Oliver; Le Doux, Joseph M; Spencer, H Trent; Doering, Christopher B; Lam, Wilbur A

2017-10-04

Ex vivo gene therapy using lentiviral vectors (LVs) is a proven approach to treat and potentially cure many hematologic disorders and malignancies but remains stymied by cumbersome, cost-prohibitive, and scale-limited production processes that cannot meet the demands of current clinical protocols for widespread clinical utilization. However, limitations in LV manufacture coupled with inefficient transduction protocols requiring significant excess amounts of vector currently limit widespread implementation. Herein, we describe a microfluidic, mass transport-based approach that overcomes the diffusion limitations of current transduction platforms to enhance LV gene transfer kinetics and efficiency. This novel ex vivo LV transduction platform is flexible in design, easy to use, scalable, and compatible with standard cell transduction reagents and LV preparations. Using hematopoietic cell lines, primary human T cells, primary hematopoietic stem and progenitor cells (HSPCs) of both murine (Sca-1 + ) and human (CD34 + ) origin, microfluidic transduction using clinically processed LVs occurs up to 5-fold faster and requires as little as one-twentieth of LV. As an in vivo validation of the microfluidic-based transduction technology, HSPC gene therapy was performed in hemophilia A mice using limiting amounts of LV. Compared to the standard static well-based transduction protocols, only animals transplanted with microfluidic-transduced cells displayed clotting levels restored to normal. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Research as a standard of care in PICU

PubMed Central

Zimmerman, Jerry J.; Anand, Kanwaljeet J. S.; Meert, Kathleen L.; Willson, Douglas F.; Newth, Christopher J. L.; Harrison, Rick; Carcillo, Joseph A.; Berger, John; Jenkins, Tammara L.; Nicholson, Carol; Dean, J. Michael

2016-01-01

Background Excellence in clinical care coupled with basic and applied research reflects the maturation of a medical subspecialty, advances that field, and provides objective data for identifying best practices. Pediatric intensive care units (PICU) are uniquely suited for conducting translational and clinical research. Moreover, multiple investigations have reported that a majority of parents are interested in their children’s participation in clinical research, even when the research offers no direct benefit to their child. However, such activity may generate ethical conflict with bedside care providers trying to acutely identify the best approach for an individual critically ill child. Ultimately, this conflict may diminish enthusiasm for the generation of scientific evidence that supports application of evidence-based medicine into PICU clinical standard work. Objective Provide an overview of current state PICU clinical research strengths, liabilities, opportunities, and barriers, and contrast this with an established pediatric hematology-oncology iterative research model that constitutes a learning healthcare system. Design Narrative review of medical literature published in English. Conclusions Currently most PICU therapy is not evidence-based. Developing a learning healthcare system in the PICU integrates clinical research into usual practice and fosters a culture of evidence-based learning and continual care improvement. As PICU mortality has significantly decreased, identification and validation of patient-centered, clinically relevant research outcome measures other than mortality is essential for future clinical trial design. Because most pediatric critical illness may be classified as rare diseases, participation in research networks will facilitate iterative, collaborative, multi-institutional investigations that over time identify best practices to improve PICU outcomes. Despite real ethical challenges, critically ill children and their families should have the opportunity to participate in translational/clinical research whenever feasible. PMID:26513203

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

PubMed

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 related to both formal and informal educational and research opportunities. It identified current nurses' strengths and weaknesses relative to all aspects of the research process, particularly in obtaining ethical approval for studies. A rolling programme of research education enabled nurses to gain essential knowledge and skills in supporting their developing research awareness, consumption and conduct of research. The NRU, through this process, has formed an effective alliance between clinical nurses and research facilitators in promoting high quality research. The foundations to continue to support this within the Trust are now well established.

Assessment of commercial NLP engines for medication information extraction from dictated clinical notes.

PubMed

Jagannathan, V; Mullett, Charles J; Arbogast, James G; Halbritter, Kevin A; Yellapragada, Deepthi; Regulapati, Sushmitha; Bandaru, Pavani

2009-04-01

We assessed the current state of commercial natural language processing (NLP) engines for their ability to extract medication information from textual clinical documents. Two thousand de-identified discharge summaries and family practice notes were submitted to four commercial NLP engines with the request to extract all medication information. The four sets of returned results were combined to create a comparison standard which was validated against a manual, physician-derived gold standard created from a subset of 100 reports. Once validated, the individual vendor results for medication names, strengths, route, and frequency were compared against this automated standard with precision, recall, and F measures calculated. Compared with the manual, physician-derived gold standard, the automated standard was successful at accurately capturing medication names (F measure=93.2%), but performed less well with strength (85.3%) and route (80.3%), and relatively poorly with dosing frequency (48.3%). Moderate variability was seen in the strengths of the four vendors. The vendors performed better with the structured discharge summaries than with the clinic notes in an analysis comparing the two document types. Although automated extraction may serve as the foundation for a manual review process, it is not ready to automate medication lists without human intervention.

Prison Health Care Governance: Guaranteeing Clinical Independence

PubMed Central

Pont, Jörg; Enggist, Stefan; Stöver, Heino; Williams, Brie; Greifinger, Robert

2018-01-01

Clinical independence is an essential component of good health care and health care professionalism, particularly in correctional settings (jails, prisons, and other places of detention), where the relationship between patients and caregivers is not based on free choice and where the punitive correctional setting can challenge optimal medical care. Independence for the delivery of health care services is defined by international standards as a critical element for quality health care in correctional settings, yet many correctional facilities do not meet these standards because of a lack of awareness, persisting legal regulations, contradictory terms of employment for health professionals, or current health care governance structures. We present recommendations for the implementation of independent health care in correctional settings. PMID:29470125

Can informed consent to research be adapted to risk?

PubMed

Bromwich, Danielle; Rid, Annette

2015-07-01

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the concern that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorisation. In this paper, we show how the standard view of informed consent--consent as autonomous authorisation--can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Current projects in Pre-analytics: where to go?

PubMed

Sapino, Anna; Annaratone, Laura; Marchiò, Caterina

2015-01-01

The current clinical practice of tissue handling and sample preparation is multifaceted and lacks strict standardisation: this scenario leads to significant variability in the quality of clinical samples. Poor tissue preservation has a detrimental effect thus leading to morphological artefacts, hampering the reproducibility of immunocytochemical and molecular diagnostic results (protein expression, DNA gene mutations, RNA gene expression) and affecting the research outcomes with irreproducible gene expression and post-transcriptional data. Altogether, this limits the opportunity to share and pool national databases into European common databases. At the European level, standardization of pre-analytical steps is just at the beginning and issues regarding bio-specimen collection and management are still debated. A joint (public-private) project entitled on standardization of tissue handling in pre-analytical procedures has been recently funded in Italy with the aim of proposing novel approaches to the neglected issue of pre-analytical procedures. In this chapter, we will show how investing in pre-analytics may impact both public health problems and practical innovation in solid tumour processing.

Laparoscopic and Robotic Total Mesorectal Excision in the Treatment of Rectal Cancer. Brief Review and Personal Remarks

PubMed Central

Bianchi, Paolo Pietro; Petz, Wanda; Luca, Fabrizio; Biffi, Roberto; Spinoglio, Giuseppe; Montorsi, Marco

2014-01-01

The current standard treatment for rectal cancer is based on a multimodality approach with preoperative radiochemotherapy in advanced cases and complete surgical removal through total mesorectal excision (TME). The most frequent surgical approach is traditional open surgery, as laparoscopic TME requires high technical skill, a long learning curve, and is not widespread, still being confined to centers with great experience in minimally invasive techniques. Nevertheless, in several studies, the laparoscopic approach, when compared to open surgery, has shown some better short-term clinical outcomes and at least comparable oncologic results. Robotic surgery for the treatment of rectal cancer is an emerging technique, which could overcome some of the technical difficulties posed by standard laparoscopy, but evidence from the literature regarding its oncologic safety and clinical outcomes is still lacking. This brief review analyses the current status of minimally invasive surgery for rectal cancer therapy, focusing on oncologic safety and the new robotic approach. PMID:24834429

Assuring the Quality of Next-Generation Sequencing in Clinical Microbiology and Public Health Laboratories.

PubMed

Gargis, Amy S; Kalman, Lisa; Lubin, Ira M

2016-12-01

Clinical microbiology and public health laboratories are beginning to utilize next-generation sequencing (NGS) for a range of applications. This technology has the potential to transform the field by providing approaches that will complement, or even replace, many conventional laboratory tests. While the benefits of NGS are significant, the complexities of these assays require an evolving set of standards to ensure testing quality. Regulatory and accreditation requirements, professional guidelines, and best practices that help ensure the quality of NGS-based tests are emerging. This review highlights currently available standards and guidelines for the implementation of NGS in the clinical and public health laboratory setting, and it includes considerations for NGS test validation, quality control procedures, proficiency testing, and reference materials. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Quantitative Pulmonary Imaging Using Computed Tomography and Magnetic Resonance Imaging

PubMed Central

Washko, George R.; Parraga, Grace; Coxson, Harvey O.

2011-01-01

Measurements of lung function, including spirometry and body plethesmography, are easy to perform and are the current clinical standard for assessing disease severity. However, these lung functional techniques do not adequately explain the observed variability in clinical manifestations of disease and offer little insight into the relationship of lung structure and function. Lung imaging and the image based assessment of lung disease has matured to the extent that it is common for clinical, epidemiologic, and genetic investigation to have a component dedicated to image analysis. There are several exciting imaging modalities currently being used for the non-invasive study of lung anatomy and function. In this review we will focus on two of them, x-ray computed tomography and magnetic resonance imaging. Following a brief introduction of each method we detail some of the most recent work being done to characterize smoking-related lung disease and the clinical applications of such knowledge. PMID:22142490

Contrast Media for X-ray and Magnetic Resonance Imaging: Development, Current Status and Future Perspectives.

PubMed

Frenzel, Thomas; Lawaczeck, Rüdiger; Taupitz, Matthias; Jost, Gregor; Lohrke, Jessica; Sieber, Martin A; Pietsch, Hubertus

2015-09-01

Over the last 120 years, the extensive advances in medical imaging allowed enhanced diagnosis and therapy of many diseases and thereby improved the quality of life of many patient generations. From the beginning, all technical solutions and imaging procedures were combined with dedicated pharmaceutical developments of contrast media, to further enhance the visualization of morphology and physiology. This symbiosis of imaging hardware and contrast media development was of high importance for the development of modern clinical radiology. Today, all available clinically approved contrast media fulfill the highest requirements for clinical safety and efficacy. All new concepts to increase the efficacy of contrast media have also to consider the high clinical safety standards and cost of goods of current marketed contrast media. Nevertheless, diagnostic imaging will contribute significantly to the progresses in medicine, and new contrast media developments are mandatory to address the medical needs of the future.

Minimum Information about T Regulatory Cells: A Step toward Reproducibility and Standardization.

PubMed

Fuchs, Anke; Gliwiński, Mateusz; Grageda, Nathali; Spiering, Rachel; Abbas, Abul K; Appel, Silke; Bacchetta, Rosa; Battaglia, Manuela; Berglund, David; Blazar, Bruce; Bluestone, Jeffrey A; Bornhäuser, Martin; Ten Brinke, Anja; Brusko, Todd M; Cools, Nathalie; Cuturi, Maria Cristina; Geissler, Edward; Giannoukakis, Nick; Gołab, Karolina; Hafler, David A; van Ham, S Marieke; Hester, Joanna; Hippen, Keli; Di Ianni, Mauro; Ilic, Natasa; Isaacs, John; Issa, Fadi; Iwaszkiewicz-Grześ, Dorota; Jaeckel, Elmar; Joosten, Irma; Klatzmann, David; Koenen, Hans; van Kooten, Cees; Korsgren, Olle; Kretschmer, Karsten; Levings, Megan; Marek-Trzonkowska, Natalia Maria; Martinez-Llordella, Marc; Miljkovic, Djordje; Mills, Kingston H G; Miranda, Joana P; Piccirillo, Ciriaco A; Putnam, Amy L; Ritter, Thomas; Roncarolo, Maria Grazia; Sakaguchi, Shimon; Sánchez-Ramón, Silvia; Sawitzki, Birgit; Sofronic-Milosavljevic, Ljiljana; Sykes, Megan; Tang, Qizhi; Vives-Pi, Marta; Waldmann, Herman; Witkowski, Piotr; Wood, Kathryn J; Gregori, Silvia; Hilkens, Catharien M U; Lombardi, Giovanna; Lord, Phillip; Martinez-Caceres, Eva M; Trzonkowski, Piotr

2017-01-01

Cellular therapies with CD4+ T regulatory cells (Tregs) hold promise of efficacious treatment for the variety of autoimmune and allergic diseases as well as posttransplant complications. Nevertheless, current manufacturing of Tregs as a cellular medicinal product varies between different laboratories, which in turn hampers precise comparisons of the results between the studies performed. While the number of clinical trials testing Tregs is already substantial, it seems to be crucial to provide some standardized characteristics of Treg products in order to minimize the problem. We have previously developed reporting guidelines called minimum information about tolerogenic antigen-presenting cells, which allows the comparison between different preparations of tolerance-inducing antigen-presenting cells. Having this experience, here we describe another minimum information about Tregs (MITREG). It is important to note that MITREG does not dictate how investigators should generate or characterize Tregs, but it does require investigators to report their Treg data in a consistent and transparent manner. We hope this will, therefore, be a useful tool facilitating standardized reporting on the manufacturing of Tregs, either for research purposes or for clinical application. This way MITREG might also be an important step toward more standardized and reproducible testing of the Tregs preparations in clinical applications.

Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries

PubMed Central

Anzai, Takayuki; Kaminishi, Masamichi; Sato, Keizo; Kaufman, Laura; Iwata, Hijiri; Nakae, Dai

2015-01-01

The Standard for the Exchange of Nonclinical Data (SEND), adopted by the US FDA, is part of a set of regulations and guidances requiring the submission of standardized electronic study data for nonclinical and clinical data submissions. SEND is the nonclinical implementation of SDTM (Study Data Tabulation Model), the standard electronic format for clinical regulatory submissions to FDA. SEND, SDTM, and the associated Controlled Terminology have been developed by CDISC (Clinical Data Interchange Standards Consortium). In order to successfully implement SEND, interdisciplinary contributions between sponsors and CROs, need a model for task allocation. This is being undertaken by the Pharmaceutical Users Software Exchange (PhUSE). Because SEND is currently the preferred submission format of the US FDA only and will become required by it starting in December 2016, only American academic societies and companies are actively involved. An exception to this is the INHAND initiative, which leads the way in standardizing terminology for toxicological pathology. On the other hand, international globalization of other clinical and nonclinical practices is not feasible because there are substantial differences between the US and non-US countries in CRO involvement in drug development. Thus, non-US countries must consider and develop approaches to SEND that meet their needs. This paper summarizes the activities of the major organizations involved in SEND development and implementation, discusses the effective use of SEND, and details a compliance scheme (research material of the Showa University School of Medicine) illustrating how pharmaceutical companies can complete a large amount of work up to an FDA application with the effective utilization of CROs and solution providers. PMID:26028814

Optimizing the European regulatory framework for sustainable bacteriophage therapy in human medicine.

PubMed

Verbeken, Gilbert; Pirnay, Jean-Paul; De Vos, Daniel; Jennes, Serge; Zizi, Martin; Lavigne, Rob; Casteels, Minne; Huys, Isabelle

2012-06-01

For practitioners at hospitals seeking to use natural (not genetically modified, as appearing in nature) bacteriophages for treatment of antibiotic-resistant bacterial infections (bacteriophage therapy), Europe's current regulatory framework for medicinal products hinders more than it facilitates. Although many experts consider bacteriophage therapy to be a promising complementary (or alternative) treatment to antibiotic therapy, no bacteriophage-specific framework for documentation exists to date. Decades worth of historical clinical data on bacteriophage therapy (from Eastern Europe, particularly Poland, and the former Soviet republics, particularly Georgia and Russia, as well as from today's 27 EU member states and the US) have not been taken into account by European regulators because these data have not been validated under current Western regulatory standards. Consequently, applicants carrying out standard clinical trials on bacteriophages in Europe are obliged to initiate clinical work from scratch. This paper argues for a reduced documentation threshold for Phase 1 clinical trials of bacteriophages and maintains that bacteriophages should not be categorized as classical medicinal products for at least two reasons: (1) such a categorization is scientifically inappropriate for this specific therapy and (2) such a categorization limits the marketing authorization process to industry, the only stakeholder with sufficient financial resources to prepare a complete dossier for the competent authorities. This paper reflects on the current regulatory framework for medicines in Europe and assesses possible regulatory pathways for the (re-)introduction of bacteriophage therapy in a way that maintains its effectiveness and safety as well as its inherent characteristics of sustainability and in situ self-amplification and limitation.

Genetic testing for retinal dystrophies and dysfunctions: benefits, dilemmas and solutions.

PubMed

Koenekoop, Robert K; Lopez, Irma; den Hollander, Anneke I; Allikmets, Rando; Cremers, Frans P M

2007-07-01

Human retinal dystrophies have unparalleled genetic and clinical diversity and are currently linked to more than 185 genetic loci. Genotyping is a crucial exercise, as human gene-specific clinical trials to study photoreceptor rescue are on their way. Testing confirms the diagnosis at the molecular level and allows for a more precise prognosis of the possible future clinical evolution. As treatments are gene-specific and the 'window of opportunity' is time-sensitive; accurate, rapid and cost-effective genetic testing will play an ever-increasing crucial role. The gold standard is sequencing but is fraught with excessive costs, time, manpower issues and finding non-pathogenic variants. Therefore, no centre offers testing of all currently 132 known genes. Several new micro-array technologies have emerged recently, that offer rapid, cost-effective and accurate genotyping. The new disease chips from Asper Ophthalmics (for Stargardt dystrophy, Leber congenital amaurosis [LCA], Usher syndromes and retinitis pigmentosa) offer an excellent first pass opportunity. All known mutations are placed on the chip and in 4 h a patient's DNA is screened. Identification rates (identifying at least one disease-associated mutation) are currently approximately 70% (Stargardt), approximately 60-70% (LCA) and approximately 45% (Usher syndrome subtype 1). This may be combined with genotype-phenotype correlations that suggest the causal gene from the clinical appearance (e.g. preserved para-arteriolar retinal pigment epithelium suggests the involvement of the CRB1 gene in LCA). As approximately 50% of the retinal dystrophy genes still await discovery, these technologies will improve dramatically as additional novel mutations are added. Genetic testing will then become standard practice to complement the ophthalmic evaluation.

Just-in-time coding of the problem list in a clinical environment.

PubMed Central

Warren, J. J.; Collins, J.; Sorrentino, C.; Campbell, J. R.

1998-01-01

Clinically useful problem lists are essential to the CPR. Providing a terminology that is standardized and understood by all clinicians is a major challenge. UNMC has developed a lexicon to support their problem list. Using a just-in-time coding strategy, the lexicon is maintained and extended prospectively in a dynamic clinical environment. The terms in the lexicon are mapped to ICD-9-CM, NANDA, and SNOMED International classification schemes. Currently, the lexicon contains 12,000 terms. This process of development and maintenance of the lexicon is described. PMID:9929226

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

PubMed

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.

Therapeutic Antibodies for Myeloid Neoplasms—Current Developments and Future Directions

PubMed Central

Schürch, Christian M.

2018-01-01

Therapeutic monoclonal antibodies (mAbs) such as antibody–drug conjugates, ligand–receptor antagonists, immune checkpoint inhibitors and bispecific T cell engagers have shown impressive efficacy in the treatment of multiple human cancers. Numerous therapeutic mAbs that have been developed for myeloid neoplasms, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), are currently investigated in clinical trials. Because AML and MDS originate from malignantly transformed hematopoietic stem/progenitor cells—the so-called leukemic stem cells (LSCs) that are highly resistant to most standard drugs—these malignancies frequently relapse and have a high disease-specific mortality. Therefore, combining standard chemotherapy with antileukemic mAbs that specifically target malignant blasts and particularly LSCs or utilizing mAbs that reinforce antileukemic host immunity holds great promise for improving patient outcomes. This review provides an overview of therapeutic mAbs for AML and MDS. Antibody targets, the molecular mechanisms of action, the efficacy in preclinical leukemia models, and the results of clinical trials are discussed. New developments and future studies of therapeutic mAbs in myeloid neoplasms will advance our understanding of the immunobiology of these diseases and enhance current therapeutic strategies. PMID:29868474

Clinical Case Reporting in the Peer-Reviewed Physical Therapy Literature: Time to Move Toward Functioning.

PubMed

Davenport, Todd E

2015-12-01

Physical therapists increasingly are contributing clinical case reports to the health literature, which form the basis for higher quality evidence that has been incorporated into clinical practice guidelines. Yet, few resources exist to assist physical therapists with the basic mechanics and quality standards of producing a clinical case report. This situation is further complicated by the absence of uniform standards for quality in case reporting. The importance of including a concise yet comprehensive description of patient functioning in all physical therapy case reports suggest the potential appropriateness of basing quality guidelines on the World Health Organization's International Classification of Functioning Disability and Health (ICF) model. The purpose of this paper is to assist physical therapists in creating high-quality clinical case reports for the peer-reviewed literature using the ICF model as a guiding framework. Along these lines, current recommendations related to the basic mechanics of writing a successful clinical case report are reviewed, as well and a proposal for uniform clinical case reporting requirements is introduced with the aim to improve the quality and feasibility of clinical case reporting in physical therapy that are informed by the ICF model. Copyright © 2013 John Wiley & Sons, Ltd.

The performance implications of pharmacy information system at the university teaching hospitals of Shiraz, Iran: Cluster approach

PubMed Central

Bayati, Saeede; Bastani, Peivand; Sagheb, Zahra Mahmoodzade; Jamalabadi, Sara; Samadbeik, Mahnaz

2017-01-01

Pharmacy information system (PIS) is becoming vital in assisting pharmacists to do their responsibilities. The aim of this study was to identify the current PIS implications in teaching hospitals affiliated with Shiraz University of Medical Science. This cross-sectional study was conducted in teaching hospitals affiliated with Shiraz University of Medical Science over the year 2016. Data were collected by observing the PIS as well as interviewing its users based on the researcher-made checklist. The checklist was prepared based on reviewing the Persian and English literature and its content validity was approved by the experts. To determine the reliability of the checklist, inter-rater reliability was used. Data were analyzed using SPSS16, and hospitals were clustered using SK-means method. In this study, the least conformity to the standards was shown in smart clinical features (4.54%), pharmaceutical companies' relationship (32.6%), and optimization of drug therapy (34.6%). In contrast, the highest conformity to the standards was shown in reporting capabilities (77.3%) and entry information and input (70.4%). Medication stock checking and optimization of drug therapy were effective features that have made a distinction between hospitals and lead to 95% variance between clusters. Based on the results, the current PIS design pays less attention to clinical features. Besides, clinical information for pharmacists and outside organization relationship were not provided by the current system. Thus, emphasis should be placed on the implementation of corrective actions to eliminate the current system's deficiencies. PMID:29184843

Current issues on a standard for surrogate pregnancy procedures

PubMed Central

2012-01-01

While Korea does not have any legal statement on surrogacy, treatments are carried out in practice. As a result, every Institutional Review Board (IRB) of each fertility clinic faces an ethical predicament in reviewing each case. There is a need to arrange the institutions' own standards of surrogate pregnancy procedures before the establishment of national or professional regulation. This article examines the legal, social, and medical issues of surrogacy to help IRBs to judge their cases. PMID:23346523

Current issues on a standard for surrogate pregnancy procedures.

PubMed

Ha, Jung-Ok

2012-12-01

While Korea does not have any legal statement on surrogacy, treatments are carried out in practice. As a result, every Institutional Review Board (IRB) of each fertility clinic faces an ethical predicament in reviewing each case. There is a need to arrange the institutions' own standards of surrogate pregnancy procedures before the establishment of national or professional regulation. This article examines the legal, social, and medical issues of surrogacy to help IRBs to judge their cases.

Recommendations for conducting controlled clinical studies of dental restorative materials.

PubMed

Hickel, R; Roulet, J-F; Bayne, S; Heintze, S D; Mjör, I A; Peters, M; Rousson, V; Randall, R; Schmalz, G; Tyas, M; Vanherle, G

2007-03-01

About 35 years ago, Ryge provided a practical approach to evaluation of clinical performance of restorative materials. This systematic approach was soon universally accepted. While that methodology has served us well, a large number of scientific methodologies and more detailed questions have arisen that require more rigor. Current restorative materials have vastly improved clinical performance and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short term clinical investigations. However, the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques. For instance, a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches. Insensitivity, combined with the continually evolving and non-standard investigator modifications of the categories, scales, and reporting methods, has created a body of literature that is extremely difficult to meaningfully interpret. In many cases, the insensitivity of the original Ryge methods is misinterpreted as good clinical performance. While there are many good features of the original system, it is now time to move to a more contemporary one. The current review approaches this challenge in two ways: (1) a proposal for a modern clinical testing protocol for controlled clinical trials, and (2) an in-depth discussion of relevant clinical evaluation parameters, providing 84 references that are primarily related to issues or problems for clinical research trials. Together, these two parts offer a standard for the clinical testing of restorative materials/procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials. Part 1 of the review considers the recruitment of subjects, restorations per subject, clinical events, validity versus bias, legal and regulatory aspects, rationales for clinical trial designs, guidelines for design, randomization, number of subjects, characteristics of participants, clinical assessment, standards and calibration, categories for assessment, criteria for evaluation, and supplemental documentation. Part 2 of the review considers categories of assessment for esthetic evaluation, functional assessment, biological responses to restorative materials, and statistical analysis of results. The overall review represents a considerable effort to include a range of clinical research interests over the past years. As part of the recognition of the importance of these suggestions, the review is being published simultaneously in identical form in both the "Journal of Adhesive Dentistry" and the "Clinical Oral Investigations." Additionally an extended abstract will be published in the "International Dental Journal" giving a link to the web full version. This should help to introduce these considerations more quickly to the scientific community.

Strategy for standardization of preeclampsia research study design.

PubMed

Myatt, Leslie; Redman, Christopher W; Staff, Anne Cathrine; Hansson, Stefan; Wilson, Melissa L; Laivuori, Hannele; Poston, Lucilla; Roberts, James M

2014-06-01

Preeclampsia remains a major problem worldwide for mothers and babies. Despite intensive study, we have not been able to improve the management or early recognition of preeclampsia. At least part of this is because of failure to standardize the approach to studying this complex syndrome. It is possible that within the syndrome there may be different phenotypes with pathogenic pathways that differ between the subtypes. The capacity to recognize and to exploit different subtypes is of obvious importance for prediction, prevention, and treatment. We present a strategy for research to study preeclampsia, which will allow discrimination of such possible subtypes and also allow comparison and perhaps combinations of findings in different studies by standardized data and biosample collection. To make studies relevant to current clinical practice, the definition of preeclampsia can be that currently used and accepted. However, more importantly, sufficient data should be collected to allow other diagnostic criteria to be used and applied retrospectively. To that end, we present what we consider to be the minimum requirements for a data set in a study of preeclampsia that will facilitate comparisons. We also present a comprehensive or optimal data set for in-depth investigation of pathophysiology. As we approach the definition of phenotypes of preeclampsia by clinical and biochemical criteria, adherence to standardized protocols will hasten our understanding of the causes of preeclampsia and development of targeted treatment strategies.

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

PubMed

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.

Implementing clinical process management of vascular wounds in a tertiary facility: impact evaluation of a performance improvement project.

PubMed

Avruscio, Giampiero; Tocco-Tussardi, Ilaria; Bordignon, Greta; Vindigni, Vincenzo

2017-01-01

Chronic vascular wounds have a significant economic and social impact on our society calling for allocation of a great deal of attention and resources. Efforts should be oriented toward the achievement of the most effective and efficient clinical management. The Angiology Unit at the University Hospital of Padova, Italy, developed a performance improvement project to enhance the quality of practice for vascular ulcers. The project consisted in a multistep process comprising a critical revision of the previous clinical process management, staff education, tightening connections between operators and services, and creation of a position for a wound care nurse. The previous standard of practice was modified according to the results of revision and the current evidence-based practice. The new standard of practice reached its full application in September 2015. The number of patients treated and the number of visits in 2015 remained almost unvaried from 2014. However, the total annual expenditure for treating vascular ulcers was reduced by ~60% from the previous year. Standardization of guidelines and practice is effective in creating an efficient clinical management and in reducing the economic burden of vascular ulcers.

Detecting inflammation in inflammatory bowel disease - how does ultrasound compare to magnetic resonance enterography using standardised scoring systems?

PubMed

Barber, Joy L; Zambrano-Perez, Alexsandra; Olsen, Øystein E; Kiparissi, Fevronia; Baycheva, Mila; Knaflez, Daniela; Shah, Neil; Watson, Tom A

2018-06-01

Magnetic resonance enterography (MRE) is the current gold standard for imaging in inflammatory bowel disease, but ultrasound (US) is a potential alternative. To determine whether US is as good as MRE for the detecting inflamed bowel, using a combined consensus score as the reference standard. We conducted a retrospective cohort study in children and adolescents <18 years with inflammatory bowel disease (IBD) at a tertiary and quaternary centre. We included children who underwent MRE and US within 4 weeks. We scored MRE using the London score and US using a score adapted from the METRIC (MR Enterography or Ultrasound in Crohn's Disease) trial. Four gastroenterologists assessed an independent clinical consensus score. A combined consensus score using the imaging and clinical scores was agreed upon and used as the reference standard to compare MRE with US. We included 53 children. At a whole-patient level, MRE scores were 2% higher than US scores. We used Lin coefficient to assess inter-observer variability. The repeatability of MRE scores was poor (Lin 0.6). Agreement for US scoring was substantial (Lin 0.95). There was a significant positive correlation between MRE and clinical consensus scores (Spearman's rho = 0.598, P=0.0053) and US and clinical consensus scores (Spearman's rho = 0.657, P=0.0016). US detects as much clinically significant bowel disease as MRE. It is possible that MRE overestimates the presence of disease when using a scoring system. This study demonstrates the feasibility of using a clinical consensus reference standard in paediatric IBD imaging studies.

Medicare long-term CPAP coverage policy: a cost-utility analysis.

PubMed

Billings, Martha E; Kapur, Vishesh K

2013-10-15

CPAP is an effective treatment for OSA that may reduce health care utilization and costs. Medicare currently reimburses the costs of long-term CPAP therapy only if the patient is adherent during a 90-day trial. If not, Medicare requires a repeat polysomnogram (PSG) and another trial which seems empirically not cost-effective. We modeled the cost-effectiveness of current Medicare policy compared to an alternative policy (clinic-only) without the adherence criterion and repeat PSG. Cost-utility and cost-effectiveness analysis. U.S. Medicare Population. N/A. N/A. We created a decision tree modeling (1) clinic only follow-up vs. (2) current Medicare policy. Costs were assigned based on Medicare reimbursement rates in 2012. Sensitivity analyses were conducted to test our assumptions. We estimated cumulative costs, overall adherence, and QALY gained for a 5-year time horizon from the perspective of Medicare as the payer. Current Medicare policy is more costly than the clinic-only policy but has higher net adherence and improved utility. Current Medicare policy compared to clinic-only policy costs $30,544 more per QALY. Current CMS policy promotes early identification of those more likely to adhere to CPAP therapy by requiring strict adherence standards. The policy effect is to deny coverage to those unlikely to use CPAP long-term and prevent wasted resources. Future studies are needed to measure long-term adherence in an elderly population with and without current adherence requirements to verify the cost-effectiveness of a policy change.

Immunotherapy for non-small cell lung cancer: current concepts and clinical trials

PubMed Central

Mayor, Marissa; Yang, Neng; Sterman, Daniel; Jones, David R.; Adusumilli, Prasad S.

2016-01-01

Recent successes in immunotherapeutic strategies are being investigated to combat cancers that have less than ideal responses to standard of care treatment, such as non-small-cell lung cancer. In this paper, we summarize concepts and the current status of immunotherapy for non-small cell lung cancer, including salient features of the major categories of immunotherapy—monoclonal antibody therapy, immune checkpoint blockade, immunotoxins, anticancer vaccines, and adoptive cell therapy. PMID:26516195

Attention-Deficit Hyperactivity Disorder: A Handbook for Diagnosis and Treatment. Fourth Edition

ERIC Educational Resources Information Center

Barkley, Russell A., Ed.

2014-01-01

Widely regarded as the standard clinical reference, this volume provides the best current knowledge about attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. The field's leading authorities address all aspects of assessment, diagnosis, and treatment, including psychological therapies and pharmacotherapy. Core…

Verbal Memory Impairment in Polydrug Ecstasy Users: A Clinical Perspective

PubMed Central

Kuypers, Kim P. C.; Theunissen, Eef L.; van Wel, Janelle H. P.; de Sousa Fernandes Perna, Elizabeth B.; Linssen, Anke; Sambeth, Anke; Schultz, Benjamin G.; Ramaekers, Johannes G.

2016-01-01

Background Ecstasy use has been associated with short-term and long-term memory deficits on a standard Word Learning Task (WLT). The clinical relevance of this has been debated and is currently unknown. The present study aimed at evaluating the clinical relevance of verbal memory impairment in Ecstasy users. To that end, clinical memory impairment was defined as decrement in memory performance that exceeded the cut-off value of 1.5 times the standard deviation of the average score in the healthy control sample. The primary question was whether being an Ecstasy user (E-user) was predictive of having clinically deficient memory performance compared to a healthy control group. Methods WLT data were pooled from four experimental MDMA studies that compared memory performance during placebo and MDMA intoxication. Control data were taken from healthy volunteers with no drug use history who completed the WLT as part of a placebo-controlled clinical trial. This resulted in a sample size of 65 E-users and 65 age- and gender-matched healthy drug-naïve controls. All participants were recruited by similar means and were tested at the same testing facilities using identical standard operating procedures. Data were analyzed using linear mixed-effects models, Bayes factor, and logistic regressions. Results Findings were that verbal memory performance of placebo-treated E-users did not differ from that of controls, and there was substantial evidence in favor of the null hypothesis. History of use was not predictive of memory impairment. During MDMA intoxication of E-users, verbal memory was impaired. Conclusion The combination of the acute and long-term findings demonstrates that, while clinically relevant memory impairment is present during intoxication, it is absent during abstinence. This suggests that use of Ecstasy/MDMA does not lead to clinically deficient memory performance in the long term. Additionally, it has to be investigated whether the current findings apply to more complex cognitive measures in diverse ‘user categories’ using a combination of genetics, imaging techniques and neuropsychological assessments. PMID:26907605

Research fellowship programs as a pathway for training independent clinical pharmacy scientists.

PubMed

Mueller, Eric W; Bishop, Jeffrey R; Kanaan, Abir O; Kiser, Tyree H; Phan, Hanna; Yang, Katherine Y

2015-03-01

The American College of Clinical Pharmacy (ACCP) Research Affairs Committee published a commentary in 2013 on training clinical pharmacy scientists in the context of changes in economic, professional, political, and research environments. The commentary centered on the opportunities for pharmacists in clinical/translational research including strategies for ACCP, colleges of pharmacy, and the profession to increase the number and impact of clinical pharmacy scientists. A postdoctoral fellowship is cited as a current training pathway, capable of producing independent and productive pharmacy researchers. However, a decline in the number of programs, decreased funding availability, and variability in fellowship program activities and research focus have brought into question the relevance of this research training pathway to meet demand and opportunities. In response to these points, this commentary examines the state of research fellowship training including the current ACCP research fellowship review process, the need for standardization of research fellowship programs, and strategies to strengthen and promote research fellowships as relevant researcher training pathways. © 2015 Pharmacotherapy Publications, Inc.

[Error prevention through management of complications in urology: standard operating procedures from commercial aviation as a model].

PubMed

Kranz, J; Sommer, K-J; Steffens, J

2014-05-01

Patient safety and risk/complication management rank among the current megatrends in modern medicine, which has undoubtedly become more complex. In time-critical, error-prone and difficult situations, which often occur repeatedly in everyday clinical practice, guidelines are inappropriate for acting rapidly and intelligently. With the establishment and consistent use of standard operating procedures like in commercial aviation, a possible strategic approach is available. These medical aids to decision-making - quick reference cards - are short, optimized instructions that enable a standardized procedure in case of medical claims.

A mixed-methods study exploring sign-off mentorship practices in relation to the Nursing and Midwifery Council standards.

PubMed

Newton, Joanna; Taylor, Rachel M; Crighton, Liz

2017-10-01

To investigate the current practice and experience of sign-off mentors in one NHS trust. In the UK, sign-off mentors support nursing students in their last clinical placement and are accountable for the final assessment of fitness to practice as a registered nurse. Mixed-methods study. The focus was on two key Nursing and Midwifery Council standards: the requirement for students to work at least 40% of their time on clinical placement with a sign-off mentor/mentor; the sign-off mentor had one-hour-per-week protected time to meet the final placement student. Data were collected through two audits of clinical and university documents and an experience survey administered to all sign-off mentors in one trust. The audits showed that only 22/42 (52%) of students were supervised by their sign-off mentor/mentor at least 40% of the time, whilst 10/42 (24%) students never worked a shift with their sign-off mentor. Only one student met their sign-off mentor every week. Complete data were available in 31/64 (47%) sign-off mentors, of whom 21/30 (70%) rarely/never had reduced clinical commitment to mentor final placement students. Furthermore, 19/28 (68%) met their student after their shift had ended with 24/30 (80%) reporting not getting any protected time. Sign-off mentors have inadequate time and resources to undertake their role, yet are accountable for confirming the student has the required knowledge and skills to practise safely. The current model needs urgent review to improve mentoring standards. Understanding how the role of the sign-off mentor is working in practice is critical to ensuring that the Nursing and Midwifery Council standards are met, ensuring students are well supported and appropriately assessed in practice, and mentoring is given the high profile it deserves to guarantee high-quality care and protecting the public. © 2016 John Wiley & Sons Ltd.

Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media.

PubMed

Hoberman, Alejandro; Paradise, Jack L; Rockette, Howard E; Jeong, Jong-Hyeon; Kearney, Diana H; Bhatnagar, Sonika; Shope, Timothy R; Muñiz, Gysella; Martin, Judith M; Kurs-Lasky, Marcia; Haralam, MaryAnn; Pope, Marcia A; Nagg, Jennifer P; Zhao, Wenchen; Miah, Mohammad Kowser; Beumer, Jan; Venkataramanan, Raman; Shaikh, Nader

2017-07-01

Amoxicillin-clavulanate (A/C) is currently the most effective oral antimicrobial in treating children with acute otitis media (AOM), but the standard dosage of 90 mg amoxicillin/6.4 mg clavulanate/kg of body weight/day commonly causes diarrhea. We examined whether an A/C formulation containing lower concentrations of clavulanate would result in less diarrhea while maintaining plasma levels of amoxicillin and clavulanate adequate to eradicate middle-ear pathogens and to achieve clinical success. We conducted an open-label study in children with AOM who were 6 to 23 months of age. In phase 1, we treated 40 children with a reduced-clavulanate A/C formulation providing 90 mg amoxicillin/3.2 mg clavulanate/kg/day for 10 days. In phase 2, we treated 72 children with the same formulation at a dosage of 80 mg amoxicillin/2.85 mg clavulanate/kg/day for 10 days. We compared the rates of protocol-defined diarrhea (PDD), diaper dermatitis, and AOM clinical response in these children with rates we had reported in children who received the standard A/C regimen, and we obtained plasma levels of amoxicillin and clavulanate at various time points. Outcomes in phase 1 children and in children who had received the standard regimen did not differ significantly. Rates of PDD in children receiving phase 2 and standard regimens were 17% and 26%, respectively ( P = 0.10). The corresponding rates of diaper dermatitis were 21% and 33% ( P = 0.04) and of AOM treatment failure were 12% and 16% ( P = 0.44). Symptomatic responses did not differ significantly between regimens; both gave clavulanate levels sufficient to inhibit β-lactamase activity. In young children with AOM, clavulanate dosages lower than those currently used may be associated with fewer side effects without reducing clinical efficacy. (This study has been registered at ClinicalTrials.gov under registration no. NCT02630992.). Copyright © 2017 American Society for Microbiology.

Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media

PubMed Central

Paradise, Jack L.; Rockette, Howard E.; Jeong, Jong-Hyeon; Kearney, Diana H.; Bhatnagar, Sonika; Shope, Timothy R.; Muñiz, Gysella; Martin, Judith M.; Kurs-Lasky, Marcia; Haralam, MaryAnn; Pope, Marcia A.; Nagg, Jennifer P.; Zhao, Wenchen; Miah, Mohammad Kowser; Beumer, Jan; Venkataramanan, Raman; Shaikh, Nader

2017-01-01

ABSTRACT Amoxicillin-clavulanate (A/C) is currently the most effective oral antimicrobial in treating children with acute otitis media (AOM), but the standard dosage of 90 mg amoxicillin/6.4 mg clavulanate/kg of body weight/day commonly causes diarrhea. We examined whether an A/C formulation containing lower concentrations of clavulanate would result in less diarrhea while maintaining plasma levels of amoxicillin and clavulanate adequate to eradicate middle-ear pathogens and to achieve clinical success. We conducted an open-label study in children with AOM who were 6 to 23 months of age. In phase 1, we treated 40 children with a reduced-clavulanate A/C formulation providing 90 mg amoxicillin/3.2 mg clavulanate/kg/day for 10 days. In phase 2, we treated 72 children with the same formulation at a dosage of 80 mg amoxicillin/2.85 mg clavulanate/kg/day for 10 days. We compared the rates of protocol-defined diarrhea (PDD), diaper dermatitis, and AOM clinical response in these children with rates we had reported in children who received the standard A/C regimen, and we obtained plasma levels of amoxicillin and clavulanate at various time points. Outcomes in phase 1 children and in children who had received the standard regimen did not differ significantly. Rates of PDD in children receiving phase 2 and standard regimens were 17% and 26%, respectively (P = 0.10). The corresponding rates of diaper dermatitis were 21% and 33% (P = 0.04) and of AOM treatment failure were 12% and 16% (P = 0.44). Symptomatic responses did not differ significantly between regimens; both gave clavulanate levels sufficient to inhibit β-lactamase activity. In young children with AOM, clavulanate dosages lower than those currently used may be associated with fewer side effects without reducing clinical efficacy. (This study has been registered at ClinicalTrials.gov under registration no. NCT02630992.) PMID:28438923

Current status of antifungal susceptibility testing methods.

PubMed

Arikan, Sevtap

2007-11-01

Antifungal susceptibility testing is a very dynamic field of medical mycology. Standardization of in vitro susceptibility tests by the Clinical and Laboratory Standards Institute (CLSI) and the European Committee for Antimicrobial Susceptibility Testing (EUCAST), and current availability of reference methods constituted the major remarkable steps in the field. Based on the established minimum inhibitory concentration (MIC) breakpoints, it is now possible to determine the susceptibilities of Candida strains to fluconazole, itraconazole, voriconazole, and flucytosine. Moreover, utility of fluconazole antifungal susceptibility tests as an adjunct in optimizing treatment of candidiasis has now been validated. While the MIC breakpoints and clinical significance of susceptibility testing for the remaining fungi and antifungal drugs remain yet unclear, modifications of the available methods as well as other methodologies are being intensively studied to overcome the present drawbacks and limitations. Among the other methods under investigation are Etest, colorimetric microdilution, agar dilution, determination of fungicidal activity, flow cytometry, and ergosterol quantitation. Etest offers the advantage of practical application and favorable agreement rates with the reference methods that are frequently above acceptable limits. However, MIC breakpoints for Etest remain to be evaluated and established. Development of commercially available, standardized colorimetric panels that are based on CLSI method parameters has added more to the antifungal susceptibility testing armamentarium. Flow cytometry, on the other hand, appears to offer rapid susceptibility testing but requires specified equipment and further evaluation for reproducibility and standardization. Ergosterol quantitation is another novel approach, which appears potentially beneficial particularly in discrimination of azole-resistant isolates from heavy trailers. The method is yet investigational and requires to be further studied. Developments in methodology and applications of antifungal susceptibility testing will hopefully provide enhanced utility in clinical guidance of antifungal therapy. However, and particularly in immunosuppressed host, in vitro susceptibility is and will remain only one of several factors that influence clinical outcome.

Quality Assurance Through Quality Improvement and Professional Development in the National Breast and Cervical Cancer Early Detection Program

PubMed Central

Siegl, Elvira J.; Miller, Jacqueline W.; Khan, Kris; Harris, Susan E.

2015-01-01

Quality assurance (QA) is the process of providing evidence that the outcome meets the established standards. Quality improvement (QI), by contrast, is the act of methodically developing ways to meet acceptable quality standards and evaluating current processes to improve overall performance. In the case of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), the desired outcome is the delivery of quality health care services to program clients. The NBCCEDP provides professional development to ensure that participating providers have current knowledge of evidence-based clinical standards regarding breast and cervical cancer screening and diagnosis and are monitoring women with abnormal screening results for timely follow-up. To assess the quality of clinical care provided to NBCCEDP clients, performance data are collected by NBCCEDP grantees and compared against predetermined Centers for Disease Control and Prevention (CDC) benchmarks known as Data Quality Indicator Guides. In this article, the authors describe 1) the development and use of indicators for QI in the NBCCEDP and 2) the professional development activities implemented to improve clinical outcomes. QA identifies problems, whereas QI systematically corrects them. The quality of service delivery and improved patient outcomes among NBCCEDP grantees has enhanced significantly because of continuous monitoring of performance and professional development. By using QA, NBCCEDP grantees can maximize the quality of patient screening, diagnostic services, and follow-up. Examples of grantee activities to maintain quality of care are also described in this report. PMID:25099901

Common Data Elements for Muscle Biopsy Reporting

PubMed Central

Dastgir, Jahannaz; Rutkowski, Anne; Alvarez, Rachel; Cossette, Stacy A.; Yan, Ke; Hoffmann, Raymond G.; Sewry, Caroline; Hayashi, Yukiko K.; Goebel, Hans-Hilmar; Bonnemann, Carsten; Lawlor, Michael W.

2016-01-01

Context There is no current standard among myopathologists for reporting muscle biopsy findings. The National Institute of Neurological Disorders and Stroke has recently launched a common data element (CDE) project to standardize neuromuscular data collected in clinical reports and to facilitate their use in research. Objective To develop a more-uniform, prospective reporting tool for muscle biopsies, incorporating the elements identified by the CDE project, in an effort to improve reporting and educational resources. Design The variation in current biopsy reporting practice was evaluated through a study of 51 muscle biopsy reports from self-reported diagnoses of genetically confirmed or undiagnosed muscle disease from the Congenital Muscle Disease International Registry. Two reviewers independently extracted data from deidentified reports and entered them into the revised CDE format to identify what was missing and whether or not information provided on the revised CDE report (complete/incomplete) could be successfully interpreted by a neuropathologist. Results Analysis of the data highlighted showed (1) inconsistent reporting of key clinical features from referring physicians, and (2) considerable variability in the reporting of pertinent positive and negative histologic findings by pathologists. Conclusions We propose a format for muscle-biopsy reporting that includes the elements in the CDE checklist and a brief narrative comment that interprets the data in support of a final interpretation. Such a format standardizes cataloging of pathologic findings across the spectrum of muscle diseases and serves emerging clinical care and research needs with the expansion of genetic-testing therapeutic trials. PMID:26132600

Electrodiagnostic applications of somatosensory evoked high-frequency EEG oscillations: Technical considerations.

PubMed

Simpson, A J; Cunningham, M O; Baker, M R

2018-03-01

High frequency oscillations (HFOs) embedded within the somatosensory evoked potential (SEP) are not routinely recorded/measured as part of standard clinical SEPs. However, HFOs could provide important additional diagnostic/prognostic information in various patient groups in whom SEPs are tested routinely. One area is the management of patients with hypoxic ischaemic encephalopathy (HIE) in the intensive care unit (ICU). However, the sensitivity of standard clinical SEP recording techniques for detecting HFOs is unknown. SEPs were recorded using routine clinical methods in 17 healthy subjects (median nerve stimulation; 0.5 ms pulse width; 5 Hz; maximum 4000 stimuli) in an unshielded laboratory. Bipolar EEG recordings were acquired (gain 50 k; bandpass 3Hz-2 kHz; sampling rate 5 kHz; non-inverting electrode 2 cm anterior to C3/C4; inverting electrode 2 cm posterior to C3/C4). Data analysis was performed in MATLAB. SEP-HFOs were detected in 65% of controls using standard clinical recording techniques. In 3 controls without significant HFOs, experiments were repeated using a linear electrode array with higher spatial sampling frequency. SEP-HFOs were observed in all 3 subjects. Currently standard clinical methods of recording SEPs are not sufficiently sensitive to permit the inclusion of SEP-HFOs in routine clinical diagnostic/prognostic assessments. Whilst an increase in the number/density of EEG electrodes should improve the sensitivity for detecting SEP-HFOs, this requires confirmation. By improving and standardising clinical SEP recording protocols to permit the acquisition/analysis of SEP-HFOs, it should be possible to gain important insights into the pathophysiology of neurological disorders and refine the management of conditions such as HIE. Copyright © 2018. Published by Elsevier Inc.

The Open Perimetry Interface: an enabling tool for clinical visual psychophysics.

PubMed

Turpin, Andrew; Artes, Paul H; McKendrick, Allison M

2012-01-01

Perimeters are commercially available instruments for measuring various attributes of the visual field in a clinical setting. They have several advantages over traditional lab-based systems for conducting vision experiments, including built-in gaze tracking and calibration, polished appearance, and attributes to increase participant comfort. Prior to this work, there was no standard to control such instruments, making it difficult and time consuming to use them for novel psychophysical experiments. This paper introduces the Open Perimetry Interface (OPI), a standard set of functions that can be used to control perimeters. Currently the standard is partially implemented in the open-source programming language R on two commercially available instruments: the Octopus 900 (a projection-based bowl perimeter produced by Haag-Streit, Switzerland) and the Heidelberg Edge Perimeter (a CRT-based system produced by Heidelberg Engineering, Germany), allowing these instruments to be used as a platform for psychophysical experimentation.

Audit in forensic pathology.

PubMed

Burke, M P; Opeskin, K

2000-09-01

Autopsy numbers in Australian hospitals have declined markedly during the past decade despite evidence of a relatively static rate of demonstrable clinical misdiagnosis during this time. The reason for this decrease in autopsy numbers is multifactorial and may include a general lack of clinical and pathologic interest in the autopsy with a possible decline in autopsy standard, a lack of clinicopathologic correlation after autopsies, and an increased emphasis on surgical biopsy reporting within hospital pathology departments. Although forensic autopsies are currently maintaining their numbers, it is incumbent on forensic pathologists to demonstrate the wealth of important information a carefully performed postmortem examination can reveal. To this end, the Pathology Division of the Victorian Institute of Forensic Medicine has instituted a program of minimum standards in varied types of coroner cases and commenced a system of internal and external audit. The minimum standard for a routine, sudden, presumed natural death is presented and the audit system is discussed.

Tuberous sclerosis complex surveillance and management: recommendations of the 2012 International Tuberous Sclerosis Complex Consensus Conference.

PubMed

Krueger, Darcy A; Northrup, Hope

2013-10-01

Tuberous sclerosis complex is a genetic disorder affecting every organ system, but disease manifestations vary significantly among affected individuals. The diverse and varied presentations and progression can be life-threatening with significant impact on cost and quality of life. Current surveillance and management practices are highly variable among region and country, reflective of the fact that last consensus recommendations occurred in 1998 and an updated, comprehensive standard is lacking that incorporates the latest scientific evidence and current best clinical practices. The 2012 International Tuberous Sclerosis Complex Consensus Group, comprising 79 specialists from 14 countries, was organized into 12 separate subcommittees, each led by a clinician with advanced expertise in tuberous sclerosis complex and the relevant medical subspecialty. Each subcommittee focused on a specific disease area with important clinical management implications and was charged with formulating key clinical questions to address within its focus area, reviewing relevant literature, evaluating the strength of data, and providing a recommendation accordingly. The updated consensus recommendations for clinical surveillance and management in tuberous sclerosis complex are summarized here. The recommendations are relevant to the entire lifespan of the patient, from infancy to adulthood, including both individuals where the diagnosis is newly made as well as individuals where the diagnosis already is established. The 2012 International Tuberous Sclerosis Complex Consensus Recommendations provide an evidence-based, standardized approach for optimal clinical care provided for individuals with tuberous sclerosis complex. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

Space Life Sciences at NASA: Spaceflight Health Policy and Standards

NASA Technical Reports Server (NTRS)

Davis, Jeffrey R.; House, Nancy G.

2006-01-01

In January 2005, the President proposed a new initiative, the Vision for Space Exploration. To accomplish the goals within the vision for space exploration, physicians and researchers at Johnson Space Center are establishing spaceflight health standards. These standards include fitness for duty criteria (FFD), permissible exposure limits (PELs), and permissible outcome limits (POLs). POLs delineate an acceptable maximum decrement or change in a physiological or behavioral parameter, as the result of exposure to the space environment. For example cardiovascular fitness for duty standards might be a measurable clinical parameter minimum that allows successful performance of all required duties. An example of a permissible exposure limit for radiation might be the quantifiable limit of exposure over a given length of time (e.g. life time radiation exposure). An example of a permissible outcome limit might be the length of microgravity exposure that would minimize bone loss. The purpose of spaceflight health standards is to promote operational and vehicle design requirements, aid in medical decision making during space missions, and guide the development of countermeasures. Standards will be based on scientific and clinical evidence including research findings, lessons learned from previous space missions, studies conducted in space analog environments, current standards of medical practices, risk management data, and expert recommendations. To focus the research community on the needs for exploration missions, NASA has developed the Bioastronautics Roadmap. The Bioastronautics Roadmap, NASA's approach to identification of risks to human space flight, revised baseline was released in February 2005. This document was reviewed by the Institute of Medicine in November 2004 and the final report was received in October 2005. The roadmap defines the most important research and operational needs that will be used to set policy, standards (define acceptable risk), and implement an overall Risk Management and Analysis process. Currently NASA is drafting spaceflight health standards for neurosensory alterations, space radiation exposure, behavioral health, muscle atrophy, cardiovascular fitness, immunological compromise, bone demineralization, and nutrition.

Building clinical data groups for electronic medical record in China.

PubMed

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

2012-04-01

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

Advances in the clinical development of heat shock protein 90 (Hsp90) inhibitors in cancers

PubMed Central

Jhaveri, Komal; Taldone, Tony; Modi, Shanu; Chiosis, Gabriela

2011-01-01

Hsp90 is an ATP dependent molecular chaperone protein which integrates multiple oncogenic pathways. As such, Hsp90 inhibition is a promising anti-cancer strategy. Several inhibitors that act on Hsp90 by binding to its N-terminal ATP pocket have entered clinical evaluation. Robust pre-clinical data suggested anti-tumor activity in multiple cancer types. Clinically, encouraging results have been demonstrated in melanoma, acute myeloid leukemia, castrate refractory prostate cancer, non-small cell lung carcinoma and multiple myeloma. In breast cancer, proof-of-concept was demonstrated by first generation Hsp90 inhibitors in combination with trastuzumab mainly in human epidermal growth factor receptor 2 (HER2) + metastatic breast cancer. There are a multitude of second generation Hsp90 inhibitors currently under investigation. To date, however, there is no FDA approved Hsp90 inhibitor nor standardized assay to ascertain Hsp90 inhibition. This review summarizes the current status of both first and second generation Hsp90 inhibitors based on their chemical classification and stage of clinical development. It also discusses the pharmacodynamic assays currently implemented in clinic as well as other novel strategies aimed at enhancing the effectiveness of Hsp90 inhibitors. Ultimately, these efforts will aid in maximizing the full potential of this class of agents. PMID:22062686

Patch testing custom isocyanate materials from the workplace.

PubMed

Burrows, Dianne; Houle, Marie-Claude; Holness, D Linn; DeKoven, Joel; Skotnicki, Sandy

2015-01-01

Patch testing with standard trays of commercially available allergens is the current practice for investigating suspected cases of isocyanate-induced allergic contact dermatitis (ACD). In some facilities, these standard trays are further supplemented with custom preparations of isocyanate-containing materials. The aim was to determine whether added value exists in patch testing patients to custom isocyanate preparations in suspected cases of ACD. We performed a retrospective analysis of 11 patients referred to our specialty clinic between January 2003 and March 2011 for suspected patients of ACD who had custom testing with isocyanate materials from their workplace. In addition to standard trays of allergens, all patients were patch tested with custom isocyanate materials from their workplaces. Three (27%) of 11 patients showed an added value in testing to custom isocyanate allergens. Of these 3 patients, one had a reaction that reinforced positive reactions to the standard isocyanate tray, but the other 2 (18%) had no reactions to any of the commercially available allergens. Because of the high proportion of reactions (27%), we recommend the use of custom testing to workplace isocyanate products as a supplement to current standard patch testing procedures.

Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group.

PubMed

Tuck, Melissa K; Chan, Daniel W; Chia, David; Godwin, Andrew K; Grizzle, William E; Krueger, Karl E; Rom, William; Sanda, Martin; Sorbara, Lynn; Stass, Sanford; Wang, Wendy; Brenner, Dean E

2009-01-01

Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the "bench to bedside" aim of translational research. It is essential that standard operating procedures, "the how" of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation.

Anterior Cervical Discectomy and Fusion (ACDF): Comparison Between Zero Profile Implants and Anterior Cervical Plate and Spacer.

PubMed

Alimi, Marjan; Njoku, Innocent; Hofstetter, Christoph P; Tsiouris, Apostolos J; Kesavabhotla, Kartik; Boockvar, John; Navarro-Ramirez, Rodrigo; Härtl, Roger

2016-04-17

Interposition grafts combined with anterior plating currently remain the gold standard for anterior cervical discectomy and fusion. The use of anterior plates increases fusion rates but may be associated with higher rates of postoperative dysphagia. The aim of the current study was to determine the clinical and radiological outcomes following anterior cervical discectomy and fusion (ACDF) using zero-profile anchored spacers versus standard interposition grafts with anterior plating. This was a retrospective case series. A total of 53 male and 51 female consecutive patients (164 total operated levels) who underwent ACDF between 2007 and 2011 were included. The mean clinical follow-up was 15.7 ± 1.2 (SEM) months for patients with zero-profile implants and 14.8 ± 2.1 months for patients with conventional ACDF with anterior plating. Patient demographics, operative details, clinical outcomes, complications, and radiographic imaging were reviewed. Dysphagia was determined using the Bazaz criteria. Clinical outcome scores improved in both groups as measured by the modified Japanese Orthopedic Association and Nurick scores. Zero-profile constructs gave rise to significantly less prevertebral soft tissue swelling compared to constructs with anterior plates postoperatively (15.74 ± 0.52 as compared to 20.48 ± 0.85 mm, p < 0.001) and at the latest follow-up (10.88 ± 0.39 mm vs. 13.72 ± 0.67 mm, p < 0.001). There was a significant difference in the incidence of dysphagia at the latest follow-up (1.5% vs. 20%, p=0.001, zero-profile vs. anterior plate, respectively). Zero-profile implants lead to functional outcomes similar to standard anterior plate constructs. Avoiding the use of an anterior locking plate may decrease the risk of persistent postoperative dysphagia.

Comparative Approaches to Understanding the Relation Between Aging and Physical Function

PubMed Central

Cesari, Matteo; Seals, Douglas R.; Shively, Carol A.; Carter, Christy S.

2016-01-01

Despite dedicated efforts to identify interventions to delay aging, most promising interventions yielding dramatic life-span extension in animal models of aging are often ineffective when translated to clinical trials. This may be due to differences in primary outcomes between species and difficulties in determining the optimal clinical trial paradigms for translation. Measures of physical function, including brief standardized testing batteries, are currently being proposed as biomarkers of aging in humans, are predictive of adverse health events, disability, and mortality, and are commonly used as functional outcomes for clinical trials. Motor outcomes are now being incorporated into preclinical testing, a positive step toward enhancing our ability to translate aging interventions to clinical trials. To further these efforts, we begin a discussion of physical function and disability assessment across species, with special emphasis on mice, rats, monkeys, and man. By understanding how physical function is assessed in humans, we can tailor measurements in animals to better model those outcomes to establish effective, standardized translational functional assessments with aging. PMID:25910845

Desiderata for a Computer-Assisted Audit Tool for Clinical Data Source Verification Audits

PubMed Central

Duda, Stephany N.; Wehbe, Firas H.; Gadd, Cynthia S.

2013-01-01

Clinical data auditing often requires validating the contents of clinical research databases against source documents available in health care settings. Currently available data audit software, however, does not provide features necessary to compare the contents of such databases to source data in paper medical records. This work enumerates the primary weaknesses of using paper forms for clinical data audits and identifies the shortcomings of existing data audit software, as informed by the experiences of an audit team evaluating data quality for an international research consortium. The authors propose a set of attributes to guide the development of a computer-assisted clinical data audit tool to simplify and standardize the audit process. PMID:20841814

Urine trouble: should we think differently about UTI?

PubMed

Price, Travis K; Hilt, Evann E; Dune, Tanaka J; Mueller, Elizabeth R; Wolfe, Alan J; Brubaker, Linda

2018-02-01

Urinary tract infection (UTI) is clinically important, given that it is one of the most common bacterial infections in adult women. However, the current understanding of UTI remains based on a now disproven concept that the urinary bladder is sterile. Thus, current standards for UTI diagnosis have significant limitations that may reduce the opportunity to improve patient care. Using data from our work and numerous other peer-reviewed studies, we identified four major limitations to the contemporary UTI description: the language of UTI, UTI diagnostic testing, the Escherichia coli-centric view of UTI, and the colony-forming units (CFU) threshold-based diagnosis. Contemporary methods and technology, combined with continued rigorous clinical research can be used to correct these limitations.

Angle imaging: Advances and challenges

PubMed Central

Quek, Desmond T L; Nongpiur, Monisha E; Perera, Shamira A; Aung, Tin

2011-01-01

Primary angle closure glaucoma (PACG) is a major form of glaucoma in large populous countries in East and South Asia. The high visual morbidity from PACG is related to the destructive nature of the asymptomatic form of the disease. Early detection of anatomically narrow angles is important and the subsequent prevention of visual loss from PACG depends on an accurate assessment of the anterior chamber angle (ACA). This review paper discusses the advantages and limitations of newer ACA imaging technologies, namely ultrasound biomicroscopy, Scheimpflug photography, anterior segment optical coherence tomography and EyeCam, highlighting the current clinical evidence comparing these devices with each other and with clinical dynamic indentation gonioscopy, the current reference standard. PMID:21150037

Personality Profiles of Intimate Partner Violence Offenders with and without PTSD

ERIC Educational Resources Information Center

Hoyt, Tim; Wray, Alisha M.; Wiggins, Kathryn T.; Gerstle, Melissa; Maclean, Peggy C.

2012-01-01

Intimate partner violence (IPV) is a serious forensic and clinical problem throughout the United States. Research aimed at defining and differentiating subgroups of IPV offenders using standardized personality instruments may eventually help with matching treatments to specific individuals to reduce recidivism. The current study used a convenience…

Exercising for Two. What's Safe for the Active Pregnant Woman?

ERIC Educational Resources Information Center

White, Jacqueline

1992-01-01

Clinical experience and recent research challenge the current standards of exercise duration and intensity for pregnant women. By carefully assessing patients' self-monitoring techniques, physicians can work with active women to create safe exercise programs during pregnancy. Safety guidelines for developing home exercise programs are included.…

Anesthetic neuroprotection: antecedents and an appraisal of preclinical and clinical data quality.

PubMed

Ishida, Kazuyoshi; Berger, Miles; Nadler, Jacob; Warner, David S

2014-01-01

Anesthetics have been studied for nearly fifty years as potential neuroprotective compounds in both perioperative and resuscitation medicine. Although anesthetics present pharmacologic properties consistent with preservation of brain viability in the context of an ischemic insult, no anesthetic has been proven efficacious for neuroprotection in humans. After such effort, it could be concluded that anesthetics are simply not neuroprotective in humans. Moreover, pharmacologic neuroprotection with non-anesthetic drugs has also repeatedly failed to be demonstrated in human acute brain injury. Recent focus has been on rectification of promising preclinical neuroprotection data and subsequent failed clinical trials. This has led to consensus guidelines for the process of transferring purported therapeutics from bench to bedside. In this review we first examined the history of anesthetic neuroprotection research. Then, a systematic review was performed to identify major clinical trials of anesthetic neuroprotection. Both the preclinical neuroprotection portfolio cited to justify a clinical trial and the design and conduct of that clinical trial were evaluated using modern standards that include the Stroke Therapy Academic Industry Roundtable (STAIR) and Consolidated Standards of Reporting Trials (CONSORT) guidelines. In publications intended to define anesthetic neuroprotection, we found overall poor quality of both preclinical efficacy analysis portfolios and clinical trial designs and conduct. Hence, using current translational research standards, it was not possible to conclude from existing data whether anesthetics ameliorate perioperative ischemic brain injury. Incorporation of advances in translational neuroprotection research conduct may provide a basis for more definitive and potentially successful clinical trials of anesthetics as neuroprotectants.

Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis.

PubMed

Ali, Ather; Kahn, Janet; Rosenberger, Lisa; Perlman, Adam I

2012-10-04

Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study. The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Clinicaltrials.gov NCT00970008 (18 August 2009).

Standardizing the Delivery of 20 μL of Hapten During Patch Testing.

PubMed

Selvick, Annika; Stauss, Kari; Strobush, Katrina; Taylor, Lauren; Picard, Alexandra; Doll, Andrea; Reeder, Margo

2016-01-01

The current method for patch test tray assembly requires hand dispensing a small volume of hapten onto chambers. Because of human error, this technique produces inaccurate and inconsistent results. The recommended volume of hapten for patch testing using Finn Chambers is 20 μL. The aims of this study were to create a device that standardizes the delivery of 20 μL and to compare it with the current hand dispensing technique. A device, named the Revolution, was created using the SolidWorks program. Five nurses in our Contact Dermatitis Clinic were asked to load 10 Finn Chambers using the current technique and also using the Revolution. Assembly time, volume of petrolatum, and accuracy of placement were measured. After the 3 trials, the nurses completed a survey on the 2 methods. The amount of petrolatum dispensed using the current technique ranged from 16 to 85 μL, with an average amount of 41.39 μL. The Revolution design dispensed an average of 19.78 μL. The current hand dispensing technique does not allow for accurate and consistent dispensing of 20 μL for patch testing. In contrast, the Revolution is an accurate and consistent device that can help standardize the patch testing method.

Microfluidic-Mass Spectrometry Interfaces for Translational Proteomics.

PubMed

Pedde, R Daniel; Li, Huiyan; Borchers, Christoph H; Akbari, Mohsen

2017-10-01

Interfacing mass spectrometry (MS) with microfluidic chips (μchip-MS) holds considerable potential to transform a clinician's toolbox, providing translatable methods for the early detection, diagnosis, monitoring, and treatment of noncommunicable diseases by streamlining and integrating laborious sample preparation workflows on high-throughput, user-friendly platforms. Overcoming the limitations of competitive immunoassays - currently the gold standard in clinical proteomics - μchip-MS can provide unprecedented access to complex proteomic assays having high sensitivity and specificity, but without the labor, costs, and complexities associated with conventional MS sample processing. This review surveys recent μchip-MS systems for clinical applications and examines their emerging role in streamlining the development and translation of MS-based proteomic assays by alleviating many of the challenges that currently inhibit widespread clinical adoption. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Cardiac output monitoring using indicator-dilution techniques: basics, limits, and perspectives.

PubMed

Reuter, Daniel A; Huang, Cecil; Edrich, Thomas; Shernan, Stanton K; Eltzschig, Holger K

2010-03-01

The ability to monitor cardiac output is one of the important cornerstones of hemodynamic assessment for managing critically ill patients at increased risk for developing cardiac complications, and in particular in patients with preexisting cardiovascular comorbidities. For >30 years, single-bolus thermodilution measurement through a pulmonary artery catheter for assessment of cardiac output has been widely accepted as the "clinical standard" for advanced hemodynamic monitoring. In this article, we review this clinical standard, along with current alternatives also based on the indicator-dilution technique, such as the transcardiopulmonary thermodilution and lithium dilution techniques. In this review, not only the underlying technical principles and the unique features but also the limitations of each application of indicator dilution are outlined.

[Strengthening innovation in clinical research methodology of acupuncture and moxibustion to promote internationalization process of acupuncture-moxibustion].

PubMed

Wang, Long; Zou, Wei; Chi, Qing-bin

2009-06-01

In order to explore the problems and countermeasure in the methodology of acupuncture and moxibustion clinical researches at present, clinical research literatures about acupuncture and moxibustion (Acup-Mox) published in recent years in our country were reviewed. For the urgent need of the current internationalization of Acup-Mox, the authors proposed the model of clinical research on Acup-Mox, which should strictly stick to the international standard and fully embody traditional Chinese medicine characteristics in the intervention measures of acupuncture. It is indicated that innovation of the methodology about clinical researches of Acup-Mox has great significance in improving the quality of clinical research on Acup-Mox in our country and promoting internationalization of Acup-Mox.

Evidence-based use of electronic clinical tracking systems in advanced practice registered nurse education: an integrative review.

PubMed

Branstetter, M Laurie; Smith, Lynette S; Brooks, Andrea F

2014-07-01

Over the past decade, the federal government has mandated healthcare providers to incorporate electronic health records into practice by 2015. This technological update in healthcare documentation has generated a need for advanced practice RN programs to incorporate information technology into education. The National Organization of Nurse Practitioner Faculties created core competencies to guide program standards for advanced practice RN education. One core competency is Technology and Information Literacy. Educational programs are moving toward the utilization of electronic clinical tracking systems to capture students' clinical encounter data. The purpose of this integrative review was to evaluate current research on advanced practice RN students' documentation of clinical encounters utilizing electronic clinical tracking systems to meet advanced practice RN curriculum outcome goals in information technology as defined by the National Organization of Nurse Practitioner Faculties. The state of the science depicts student' and faculty attitudes, preferences, opinions, and data collections of students' clinical encounters. Although electronic clinical tracking systems were utilized to track students' clinical encounters, these systems have not been evaluated for meeting information technology core competency standards. Educational programs are utilizing electronic clinical tracking systems with limited evidence-based literature evaluating the ability of these systems to meet the core competencies in advanced practice RN programs.

Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols.

PubMed

Charvet, Leigh E; Kasschau, Margaret; Datta, Abhishek; Knotkova, Helena; Stevens, Michael C; Alonzo, Angelo; Loo, Colleen; Krull, Kevin R; Bikson, Marom

2015-01-01

The effect of transcranial direct current stimulation (tDCS) is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: (1) training of staff in tDCS treatment and supervision; (2) assessment of the user's capability to participate in tDCS remotely; (3) ongoing training procedures and materials including assessments of the user and/or caregiver; (4) simple and fail-safe electrode preparation techniques and tDCS headgear; (5) strict dose control for each session; (6) ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol), with corresponding corrective steps as required; (7) monitoring for treatment-emergent adverse effects; (8) guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population's level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care) following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.

[Role of rifaximin in the treatment of hepatic encephalopathy].

PubMed

Sanchez-Delgado, Jordi; Miquel, Mireia

2016-04-01

Hepatic encephalopathy (HE) is a frequent and serious complication of liver cirrhosis. In addition to correction of the precipitating factors, the most commonly used treatments are non-absorbable disaccharides and rifaximin. Many of the recommendations are based on current clinical practice and there are few randomized controlled trials. Currently, rifaximin should be initiated during an episode of EH if, after 24-48 hours of non-absorbable disaccharide therapy, there is no clinical improvement. In recurrent EH, it is advisable to add rifaximin in patients under non-absorbable disaccharide therapy who develop a new episode. Currently, standard treatment with rifaximin for minimal EH is not recommended. Rifaximin is effective in the acute treatment of overt encephalopathy and in preventing recurrence. Copyright © 2015 Elsevier España, S.L.U. and AEEH y AEG. All rights reserved.

Impact of imaging measurements on response assessment in glioblastoma clinical trials

PubMed Central

Reardon, David A.; Ballman, Karla V.; Buckner, Jan C.; Chang, Susan M.; Ellingson, Benjamin M.

2014-01-01

We provide historical and scientific guidance on imaging response assessment for incorporation into clinical trials to stimulate effective and expedited drug development for recurrent glioblastoma by addressing 3 fundamental questions: (i) What is the current validation status of imaging response assessment, and when are we confident assessing response using today's technology? (ii) What imaging technology and/or response assessment paradigms can be validated and implemented soon, and how will these technologies provide benefit? (iii) Which imaging technologies need extensive testing, and how can they be prospectively validated? Assessment of T1 +/− contrast, T2/FLAIR, diffusion, and perfusion-imaging sequences are routine and provide important insight into underlying tumor activity. Nonetheless, utility of these data within and across patients, as well as across institutions, are limited by challenges in quantifying measurements accurately and lack of consistent and standardized image acquisition parameters. Currently, there exists a critical need to generate guidelines optimizing and standardizing MRI sequences for neuro-oncology patients. Additionally, more accurate differentiation of confounding factors (pseudoprogression or pseudoresponse) may be valuable. Although promising, diffusion MRI, perfusion MRI, MR spectroscopy, and amino acid PET require extensive standardization and validation. Finally, additional techniques to enhance response assessment, such as digital T1 subtraction maps, warrant further investigation. PMID:25313236

A standardized model for predicting flap failure using indocyanine green dye

NASA Astrophysics Data System (ADS)

Zimmermann, Terence M.; Moore, Lindsay S.; Warram, Jason M.; Greene, Benjamin J.; Nakhmani, Arie; Korb, Melissa L.; Rosenthal, Eben L.

2016-03-01

Techniques that provide a non-invasive method for evaluation of intraoperative skin flap perfusion are currently available but underutilized. We hypothesize that intraoperative vascular imaging can be used to reliably assess skin flap perfusion and elucidate areas of future necrosis by means of a standardized critical perfusion threshold. Five animal groups (negative controls, n=4; positive controls, n=5; chemotherapy group, n=5; radiation group, n=5; chemoradiation group, n=5) underwent pre-flap treatments two weeks prior to undergoing random pattern dorsal fasciocutaneous flaps with a length to width ratio of 2:1 (3 x 1.5 cm). Flap perfusion was assessed via laser-assisted indocyanine green dye angiography and compared to standard clinical assessment for predictive accuracy of flap necrosis. For estimating flap-failure, clinical prediction achieved a sensitivity of 79.3% and a specificity of 90.5%. When average flap perfusion was more than three standard deviations below the average flap perfusion for the negative control group at the time of the flap procedure (144.3+/-17.05 absolute perfusion units), laser-assisted indocyanine green dye angiography achieved a sensitivity of 81.1% and a specificity of 97.3%. When absolute perfusion units were seven standard deviations below the average flap perfusion for the negative control group, specificity of necrosis prediction was 100%. Quantitative absolute perfusion units can improve specificity for intraoperative prediction of viable tissue. Using this strategy, a positive predictive threshold of flap failure can be standardized for clinical use.

Standardized protocols for quality control of MRM-based plasma proteomic workflows.

PubMed

Percy, Andrew J; Chambers, Andrew G; Smith, Derek S; Borchers, Christoph H

2013-01-04

Mass spectrometry (MS)-based proteomics is rapidly emerging as a viable technology for the identification and quantitation of biological samples, such as human plasma--the most complex yet commonly employed biofluid in clinical analyses. The transition from a qualitative to quantitative science is required if proteomics is going to successfully make the transition to a clinically useful technique. MS, however, has been criticized for a lack of reproducibility and interlaboratory transferability. Currently, the MS and plasma proteomics communities lack standardized protocols and reagents to ensure that high-quality quantitative data can be accurately and precisely reproduced by laboratories across the world using different MS technologies. Toward addressing this issue, we have developed standard protocols for multiple reaction monitoring (MRM)-based assays with customized isotopically labeled internal standards for quality control of the sample preparation workflow and the MS platform in quantitative plasma proteomic analyses. The development of reference standards and their application to a single MS platform is discussed herein, along with the results from intralaboratory tests. The tests highlighted the importance of the reference standards in assessing the efficiency and reproducibility of the entire bottom-up proteomic workflow and revealed errors related to the sample preparation and performance quality and deficits of the MS and LC systems. Such evaluations are necessary if MRM-based quantitative plasma proteomics is to be used in verifying and validating putative disease biomarkers across different research laboratories and eventually in clinical laboratories.

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

Medical decision-making capacity in cognitively impaired Parkinson's disease patients without dementia.

PubMed

Martin, Roy C; Okonkwo, Ozioma C; Hill, Joni; Griffith, H Randall; Triebel, Kristen; Bartolucci, Alfred; Nicholas, Anthony P; Watts, Ray L; Stover, Natividad; Harrell, Lindy E; Clark, David; Marson, Daniel C

2008-10-15

Little is currently known about the higher order functional skills of patients with Parkinson disease and cognitive impairment. Medical decision-making capacity (MDC) was assessed in patients with Parkinson's disease (PD) with cognitive impairment and dementia. Participants were 16 patients with PD and cognitive impairment without dementia (PD-CIND), 16 patients with PD dementia (PDD), and 22 healthy older adults. All participants were administered the Capacity to Consent to Treatment Instrument (CCTI), a standardized capacity instrument assessing MDC under five different consent standards. Parametric and nonparametric statistical analyses were utilized to examine capacity performance on the consent standards. In addition, capacity outcomes (capable, marginally capable, or incapable outcomes) on the standards were identified for the two patient groups. Relative to controls, PD-CIND patients demonstrated significant impairment on the understanding treatment consent standard, clinically the most stringent CCTI standard. Relative to controls and PD-CIND patients, PDD patients were impaired on the three clinical standards of understanding, reasoning, and appreciation. The findings suggest that impairment in decisional capacity is already present in cognitively impaired patients with PD without dementia and increases as these patients develop dementia. Clinicians and researchers should carefully assess decisional capacity in all patients with PD with cognitive impairment. (c) 2008 Movement Disorder Society.

Harmonizing clinical terminologies: driving interoperability in healthcare.

PubMed

Hamm, Russell A; Knoop, Sarah E; Schwarz, Peter; Block, Aaron D; Davis, Warren L

2007-01-01

Internationally, there are countless initiatives to build National Healthcare Information Networks (NHIN) that electronically interconnect healthcare organizations by enhancing and integrating current information technology (IT) capabilities. The realization of such NHINs will enable the simple and immediate exchange of appropriate and vital clinical data among participating organizations. In order for institutions to accurately and automatically exchange information, the electronic clinical documents must make use of established clinical codes, such as those of SNOMED-CT, LOINC and ICD-9 CM. However, there does not exist one universally accepted coding scheme that encapsulates all pertinent clinical information for the purposes of patient care, clinical research and population heatlh reporting. In this paper, we propose a combination of methods and standards that target the harmonization of clinical terminologies and encourage sustainable, interoperable infrastructure for healthcare.

Is the current standard of care leading to cost-effective outcomes for patients with type 2 diabetes requiring insulin? A long-term health economic analysis for the UK.

PubMed

Valentine, W J; Curtis, B H; Pollock, R F; Van Brunt, K; Paczkowski, R; Brändle, M; Boye, K S; Kendall, D M

2015-07-01

The aim of the analysis was to investigate whether insulin intensification, based on the use of intensive insulin regimens as recommended by the current standard of care in routine clinical practice, would be cost-effective for patients with type 2 diabetes in the UK. Clinical data were derived from a retrospective analysis of 3185 patients with type 2 diabetes on basal insulin in The Health Improvement Network (THIN) general practice database. In total, 48% (614 patients) intensified insulin therapy, defined by adding bolus or premix insulin to a basal regimen, which was associated with a reduction in HbA1c and an increase in body mass index. Projections of clinical outcomes and costs (2011 GBP) over patients' lifetimes were made using a recently validated type 2 diabetes model. Immediate insulin intensification was associated with improvements in life expectancy, quality-adjusted life expectancy and time to onset of complications versus no intensification or delaying intensification by 2, 4, 6, or 8 years. Direct costs were higher with the insulin intensification strategy (due to the acquisition costs of insulin). Incremental cost-effectiveness ratios for insulin intensification were GBP 32,560, GBP 35,187, GBP 40,006, GBP 48,187 and GBP 55,431 per QALY gained versus delaying intensification 2, 4, 6 and 8 years, and no intensification, respectively. Although associated with improved clinical outcomes, insulin intensification as practiced in the UK has a relatively high cost per QALY and may not lead to cost-effective outcomes for patients with type 2 diabetes as currently defined by UK cost-effectiveness thresholds. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Localized renal cell carcinoma management: an update.

PubMed

Heldwein, Flavio L; McCullough, T Casey; Souto, Carlos A V; Galiano, Marc; Barret, Eric

2008-01-01

To review the current modalities of treatment for localized renal cell carcinoma. A literature search for keywords: renal cell carcinoma, radical nephrectomy, nephron sparing surgery, minimally invasive surgery, and cryoablation was performed for the years 2000 through 2008. The most relevant publications were examined. New epidemiologic data and current treatment of renal cancer were covered. Concerning the treatment of clinically localized disease, the literature supports the standardization of partial nephrectomy and laparoscopic approaches as therapeutic options with better functional results and oncologic success comparable to standard radical resection. Promising initial results are now available for minimally invasive therapies, such as cryotherapy and radiofrequency ablation. Active surveillance has been reported with acceptable results, including for those who are poor surgical candidates. This review covers current advances in radical and conservative treatments of localized kidney cancer. The current status of nephron-sparing surgery, ablative therapies, and active surveillance based on natural history has resulted in great progress in the management of localized renal cell carcinoma.

Antitumor action of temozolomide, ritonavir and aprepitant against human glioma cells.

PubMed

Kast, Richard E; Ramiro, Susana; Lladó, Sandra; Toro, Salvador; Coveñas, Rafael; Muñoz, Miguel

2016-02-01

In the effort to find better treatments for glioblastoma we tested several currently marketed non-chemotherapy drugs for their ability to enhance the standard cytotoxic drug currently used to treat glioblastoma- temozolomide. We tested four antiviral drugs- acyclovir, cidofovir, maraviroc, ritonavir, and an anti-emetic, aprepitant. We found no cytotoxicity of cidofovir and discussed possible reasons for discrepancy from previous findings of others. We also found no cytotoxicity from acyclovir or maraviroc also in contradistinction to predictions. Cytotoxicity to glioma cell line GAMG for temozolomide alone was 14%, aprepitant alone 7%, ritonavir alone 14%, while temozolomide + aprepitant was 19%, temozolomide + ritonavir 34%, ritonavir + aprepitant 64 %, and all three, temozolomide + ritonavir + aprepitant 78%. We conclude that a remarkable synergy exists between aprepitant and ritonavir. Given the long clinical experience with these two well-tolerated drugs in treating non-cancer conditions, and the current median survival of glioblastoma of 2 years, a trial is warranted of adding these two simple drugs to current standard treatment with temozolomide.

Non-invasive diagnostic platforms in management of non-small cell lung cancer: opportunities and challenges

PubMed Central

Pennell, Nathan A.

2017-01-01

Several non-invasive diagnostic platforms are already being incorporated in routine clinical practice in the work up and monitoring of patients with lung cancer. These approaches have great potential to improve patient selection and monitor patients while on therapy, however several challenges exist in clinical validation and standardization of such platforms. In this review, we summarize the current technologies available for non-invasive diagnostic evaluation from the blood of patients with non-small cell lung cancer (NSCLC), and discuss the technical and logistical challenges associated incorporating such testing in clinical practice. PMID:29057238

The level of laboratory testing required for diagnosis or exclusion of a platelet function disorder using platelet aggregation and secretion assays.

PubMed

Mezzano, Diego; Quiroga, Teresa; Pereira, Jaime

2009-03-01

The major advances from research on platelet molecular and cell biology, physiology, and pathophysiology over the past decades have not been adequately translated to clinical laboratory diagnosis. Hereditary platelet function disorders (PFDs) are at least as prevalent in the general population as von Willebrand disease (VWD) although PFDs tend not be as well recognized or evaluated. Clinical mucous and skin bleeding in patients with PFDs is prototypic of primary hemostasis disorders, and the bleeding pattern is not distinguishable from that of other primary hemostasis disorders such as VWD. However, different treatment needs, between these discrete disorders, make a precise diagnosis mandatory. Currently, clinicians receive reliable laboratory reports when testing patients with severe PFDs, such as Glanzmann thrombasthenia and Bernard-Soulier syndrome, due to the distinctive laboratory defects that these disorders present, together with the availability of differential diagnostic tests. This is not the case for the majority of PFDs generically classified as "platelet secretion disorders," which are a heterogeneous group of "mild bleeding disorders," for which there are not universally accepted diagnostic criteria. An important reason for robust diagnostic tests is the high proportion (more than 50% in some reports) of patients with unequivocal bleeding who have no precise diagnosis established after a complete laboratory workup. It is paradoxical that the current "gold standard" test for PFD diagnosis, light transmission aggregometry (LTA), has not been standardized after more than four decades of worldwide clinical use. This review describes current diagnostic assays for PFD in a clinical hemostasis laboratory, relating these with current knowledge on platelet function and pathophysiology. Special emphasis will be given to LTA and platelet secretion tests, as well as to the reasons why sensitive tests are needed to explore the lesser known participation of platelets in blood clotting and fibrinolytic processes.

Contribution of Clinical Archetypes, and the Challenges, towards Achieving Semantic Interoperability for EHRs.

PubMed

Tapuria, Archana; Kalra, Dipak; Kobayashi, Shinji

2013-12-01

The objective is to introduce 'clinical archetype' which is a formal and agreed way of representing clinical information to ensure interoperability across and within Electronic Health Records (EHRs). The paper also aims at presenting the challenges building quality labeled clinical archetypes and the challenges towards achieving semantic interoperability between EHRs. Twenty years of international research, various European healthcare informatics projects and the pioneering work of the openEHR Foundation have led to the following results. The requirements for EHR information architectures have been consolidated within ISO 18308 and adopted within the ISO 13606 EHR interoperability standard. However, a generic EHR architecture cannot ensure that the clinical meaning of information from heterogeneous sources can be reliably interpreted by receiving systems and services. Therefore, clinical models called 'clinical archetypes' are required to formalize the representation of clinical information within the EHR. Part 2 of ISO 13606 defines how archetypes should be formally represented. The current challenge is to grow clinical communities to build a library of clinical archetypes and to identify how evidence of best practice and multi-professional clinical consensus should best be combined to define archetypes at the optimal level of granularity and specificity and quality label them for wide adoption. Standardizing clinical terms within EHRs using clinical terminology like Systematized Nomenclature of Medicine Clinical Terms is also a challenge. Clinical archetypes would play an important role in achieving semantic interoperability within EHRs. Attempts are being made in exploring the design and adoption challenges for clinical archetypes.

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

PubMed

Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

2017-07-01

Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles and should be routinely followed. However, seven out of 15 current guideline sections (describing a decision problem, choosing type of economic evaluation, selecting comparators, determining the study perspective, estimating effectiveness, measuring and valuing health, and assessing resource use and costs) may require additional role-specific considerations to capture costs and effects of these roles. Current guidelines for economic evaluation should form the foundation for economic evaluations of nurse practitioner and clinical nurse specialist roles. The proposed role-specific considerations, which clarify application of standard guidelines sections to economic evaluation of nurse practitioner and clinical nurse specialist roles, may strengthen the quality and comprehensiveness of future economic evaluations of these roles. Copyright © 2017 Elsevier Ltd. All rights reserved.

QUEST‐RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries

PubMed Central

Sokka, Tuulikki; Kautiainen, Hannu; Toloza, Sergio; Mäkinen, Heidi; Verstappen, Suzan M M; Hetland, Merete Lund; Naranjo, Antonio; Baecklund, Eva; Herborn, Gertraud; Rau, Rolf; Cazzato, Massimiliano; Gossec, Laure; Skakic, Vlado; Gogus, Feride; Sierakowski, Stanislaw; Bresnihan, Barry; Taylor, Peter; McClinton, Catherine; Pincus, Theodore

2007-01-01

Objective To conduct a cross‐sectional review of non‐selected consecutive outpatients with rheumatoid arthritis (RA) as part of standard clinical care in 15 countries for an overview of the characteristics of patients with RA. Methods The review included current disease activity using data from clinical assessment and a patient self‐report questionnaire, which was translated into each language. Data on demographic, disease and treatment‐related variables were collected and analysed using descriptive statistics. Variation in disease activity on DAS28 (disease activity score on 28‐joint count) within and between countries was graphically analysed. A median regression model was applied to analyse differences in disease activity between countries. Results Between January 2005 and October 2006, the QUEST‐RA (Quantitative Patient Questionnaires in Standard Monitoring of Patients with Rheumatoid Arthritis) project included 4363 patients from 48 sites in 15 countries; 78% were female, >90% Caucasian, mean age was 57 years and mean disease duration was 11.5 years. More than 80% of patients had been treated with methotrexate in all but three countries. Overall, patients had an active disease with a median DAS28 of 4.0, with a significant variation between countries (p<0.001). Among 42 sites with >50 patients included, low disease activity of DAS28 ⩽3.2 was found in the majority of patients in seven sites in five countries; in eight sites in five other countries, >50% of patients had high disease activity of DAS28 >5.1. Conclusions This international multicentre cross‐sectional database provides an overview of clinical status and treatments of patients with RA in standard clinical care in 2005–6 including countries that are infrequently involved in clinical research projects. PMID:17412740

CR softcopy display presets based on optimum visualization of specific findings

NASA Astrophysics Data System (ADS)

Andriole, Katherine P.; Gould, Robert G.; Webb, W. R.

1999-07-01

The purpose of this research is to assess the utility of providing presets for computed radiography (CR) softcopy display, based not on the window/level settings, but on image processing applied to the image based on optimization for visualization of specific findings, pathologies, etc. Clinical chest images are acquired using an Agfa ADC 70 CR scanner, and transferred over the PACS network to an image processing station which has the capability to perform multiscale contrast equalization. The optimal image processing settings per finding are developed in conjunction with a thoracic radiologist by manipulating the multiscale image contrast amplification algorithm parameters. Softcopy display of images processed with finding-specific settings are compared with the standard default image presentation for fifty cases of each category. Comparison is scored using a five point scale with positive one and two denoting the standard presentation is preferred over the finding-specific presets, negative one and two denoting the finding-specific preset is preferred over the standard presentation, and zero denoting no difference. Presets have been developed for pneumothorax and clinical cases are currently being collected in preparation for formal clinical trials. Subjective assessments indicate a preference for the optimized-preset presentation of images over the standard default, particularly by inexperienced radiology residents and referring clinicians.

Randomized trials and quality assurance in gastric cancer surgery.

PubMed

Dikken, Johan L; Cats, Annemieke; Verheij, Marcel; van de Velde, Cornelis J H

2013-03-01

A D2 lymphadenectomy can be considered standard of surgical care for advanced resectable gastric cancer. Currently, several multimodality strategies are used, including postoperative monochemotherapy in Asia, postoperative chemoradiotherapy in the United States, and perioperative chemotherapy in Europe. As the majority of gastric cancer patients are treated outside the framework of clinical trials, quality assurance programs, including referral to high-volume centers and clinical auditing are needed to improve gastric cancer care on a nationwide level. Copyright © 2012 Wiley Periodicals, Inc.

Managing the genomic revolution in cancer diagnostics.

PubMed

Nguyen, Doreen; Gocke, Christopher D

2017-08-01

Molecular tumor profiling is now a routine part of patient care, revealing targetable genomic alterations and molecularly distinct tumor subtypes with therapeutic and prognostic implications. The widespread adoption of next-generation sequencing technologies has greatly facilitated clinical implementation of genomic data and opened the door for high-throughput multigene-targeted sequencing. Herein, we discuss the variability of cancer genetic profiling currently offered by clinical laboratories, the challenges of applying rapidly evolving medical knowledge to individual patients, and the need for more standardized population-based molecular profiling.

An early evaluation of clinical and economic costs and benefits of implementing point of care NAAT tests for Chlamydia trachomatis and Neisseria gonorrhoea in genitourinary medicine clinics in England.

PubMed

Turner, Katherine M E; Round, Jeff; Horner, Patrick; Macleod, John; Goldenberg, Simon; Deol, Arminder; Adams, Elisabeth J

2014-03-01

To estimate the costs and benefits of clinical pathways incorporating a point of care (POC) nucleic acid amplification test (NAAT) for chlamydia and gonorrhoea in genitourinary medicine (GUM) clinics compared with standard off-site laboratory testing. We simulated 1.2 million GUM clinic attendees in England. A simulation in Microsoft Excel was developed to compare existing standard pathways of management for chlamydia and gonorrhoea with a POC NAAT. We conducted scenario analyses to evaluate the robustness of the model findings. The primary outcome was the incremental cost-effectiveness ratio. Secondary outcomes included the number of inappropriate treatments, complications and transmissions averted. The baseline cost of using the point of POC NAAT was £103.9 million compared with £115.6 million for standard care. The POC NAAT was also associated with a small increase of 46 quality adjusted life years, making the new test both more effective and cheaper. Over 95 000 inappropriate treatments might be avoided by using a POC NAAT. Patients receive diagnosis and treatment on the same day as testing, which may also prevent 189 cases of pelvic inflammatory disease and 17 561 onward transmissions annually. Replacing standard laboratory tests for chlamydia and gonorrhoea with a POC test could be cost saving and patients would benefit from more accurate diagnosis and less unnecessary treatment. Overtreatment currently accounts for about a tenth of the reported treatments for chlamydia and gonorrhoea and POC NAATs would effectively eliminate the need for presumptive treatment.

Current standard rules of combined anteversion prevent prosthetic impingement but ignore osseous contact in total hip arthroplasty.

PubMed

Weber, Markus; Woerner, Michael; Craiovan, Benjamin; Voellner, Florian; Worlicek, Michael; Springorum, Hans-Robert; Grifka, Joachim; Renkawitz, Tobias

2016-12-01

In this prospective study of 135 patients undergoing cementless total hip arthroplasty (THA) we asked whether six current definitions of combined anteversion prevent impingement and increase postoperative patient individual impingement-free range-of-motion (ROM). Implant position was measured by an independent, external institute on 3D-CT performed six weeks post-operatively. Post-operative ROM was calculated using a CT-based algorithm detecting osseous and/or prosthetic impingement by virtual hip movement. Additionally, clinical ROM was evaluated pre-operatively and one-year post-operatively by a blinded observer. Combined component position of cup and stem according to the definitions of Ranawat, Widmer, Dorr, Hisatome and Yoshimine inhibited prosthetic impingement in over 90 %, while combined osseous and prosthetic impingement still occurred in over 40 % of the cases. The recommendations by Jolles, Widmer, Dorr, Yoshimine and Hisatome enabled higher flexion (p ≤ 0.001) and internal rotation (p ≤ 0.006). Clinically, anteversion rules of Widmer and Yoshimine provided one-year post-operatively statistically but not clinically relevant higher internal rotation (p ≤0.034). Standard rules of combined anteversion detect prosthetic but fail to prevent combined osseous and prosthetic impingement in THA. Future models will have to account for the patient-individual anatomic situation to ensure impingement-free ROM.

Current Status of Interventional Radiology Treatment of Infrapopliteal Arterial Disease

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rand, T., E-mail: thomas.rand@wienkav.at; Uberoi, R.

2013-06-15

Treatment of infrapopliteal arteries has developed to a standard technique during the past two decades. With the introduction of innovative devices, a variety of techniques has been created and is still under investigation. Treatment options range from plain balloon angioplasty (POBA), all sorts of stent applications, such as bare metal, balloon expanding, self-expanding, coated and drug-eluting stents, and bio-absorbable stents, to latest developments, such as drug-eluting balloons. Regarding the scientific background, several prospective, randomized studies with relevant numbers of patients have been (or will be) published that are Level I evidence. In contrast to older studies, which primarily were basedmore » mostly on numeric parameters, such as diameters or residual stenoses, more recent study concepts focus increasingly on clinical features, such as amputation rate improvement or changes of clinical stages and quality of life standards. Although it is still not decided, which of the individual techniques might be the best one, we can definitely conclude that whatever treatment of infrapopliteal arteries will be used it is of substantial benefit for the patient. Therefore, the goal of this review is to give an overview about the current developments and techniques for the treatment of infrapopliteal arteries, to present clinical and technical results, to weigh individual techniques, and to discuss the recent developments.« less

Recommendations for the Generation, Quantification, Storage, and Handling of Peptides Used for Mass Spectrometry-Based Assays.

PubMed

Hoofnagle, Andrew N; Whiteaker, Jeffrey R; Carr, Steven A; Kuhn, Eric; Liu, Tao; Massoni, Sam A; Thomas, Stefani N; Townsend, R Reid; Zimmerman, Lisa J; Boja, Emily; Chen, Jing; Crimmins, Daniel L; Davies, Sherri R; Gao, Yuqian; Hiltke, Tara R; Ketchum, Karen A; Kinsinger, Christopher R; Mesri, Mehdi; Meyer, Matthew R; Qian, Wei-Jun; Schoenherr, Regine M; Scott, Mitchell G; Shi, Tujin; Whiteley, Gordon R; Wrobel, John A; Wu, Chaochao; Ackermann, Brad L; Aebersold, Ruedi; Barnidge, David R; Bunk, David M; Clarke, Nigel; Fishman, Jordan B; Grant, Russ P; Kusebauch, Ulrike; Kushnir, Mark M; Lowenthal, Mark S; Moritz, Robert L; Neubert, Hendrik; Patterson, Scott D; Rockwood, Alan L; Rogers, John; Singh, Ravinder J; Van Eyk, Jennifer E; Wong, Steven H; Zhang, Shucha; Chan, Daniel W; Chen, Xian; Ellis, Matthew J; Liebler, Daniel C; Rodland, Karin D; Rodriguez, Henry; Smith, Richard D; Zhang, Zhen; Zhang, Hui; Paulovich, Amanda G

2016-01-01

For many years, basic and clinical researchers have taken advantage of the analytical sensitivity and specificity afforded by mass spectrometry in the measurement of proteins. Clinical laboratories are now beginning to deploy these work flows as well. For assays that use proteolysis to generate peptides for protein quantification and characterization, synthetic stable isotope-labeled internal standard peptides are of central importance. No general recommendations are currently available surrounding the use of peptides in protein mass spectrometric assays. The Clinical Proteomic Tumor Analysis Consortium of the National Cancer Institute has collaborated with clinical laboratorians, peptide manufacturers, metrologists, representatives of the pharmaceutical industry, and other professionals to develop a consensus set of recommendations for peptide procurement, characterization, storage, and handling, as well as approaches to the interpretation of the data generated by mass spectrometric protein assays. Additionally, the importance of carefully characterized reference materials-in particular, peptide standards for the improved concordance of amino acid analysis methods across the industry-is highlighted. The alignment of practices around the use of peptides and the transparency of sample preparation protocols should allow for the harmonization of peptide and protein quantification in research and clinical care. © 2015 American Association for Clinical Chemistry.

Step Up-Not On-The Step 2 Clinical Skills Exam: Directors of Clinical Skills Courses (DOCS) Oppose Ending Step 2 CS.

PubMed

Ecker, David J; Milan, Felise B; Cassese, Todd; Farnan, Jeanne M; Madigosky, Wendy S; Massie, F Stanford; Mendez, Paul; Obadia, Sharon; Ovitsh, Robin K; Silvestri, Ronald; Uchida, Toshiko; Daniel, Michelle

2018-05-01

Recently, a student-initiated movement to end the United States Medical Licensing Examination Step 2 Clinical Skills and the Comprehensive Osteopathic Medical Licensing Examination Level 2-Performance Evaluation has gained momentum. These are the only national licensing examinations designed to assess clinical skills competence in the stepwise process through which physicians gain licensure and certification. Therefore, the movement to end these examinations and the ensuing debate merit careful consideration. The authors, elected representatives of the Directors of Clinical Skills Courses, an organization comprising clinical skills educators in the United States and beyond, believe abolishing the national clinical skills examinations would have a major negative impact on the clinical skills training of medical students, and that forfeiting a national clinical skills competency standard has the potential to diminish the quality of care provided to patients. In this Perspective, the authors offer important additional background information, outline key concerns regarding the consequences of ending these national clinical skills examinations, and provide recommendations for moving forward: reducing the costs for students, exploring alternatives, increasing the value and transparency of the current examinations, recognizing and enhancing the strengths of the current examinations, and engaging in a national dialogue about the issue.

International Standards and Reference Materials for Quantitative Molecular Infectious Disease Testing

PubMed Central

Madej, Roberta M.; Davis, Jack; Holden, Marcia J.; Kwang, Stan; Labourier, Emmanuel; Schneider, George J.

2010-01-01

The utility of quantitative molecular diagnostics for patient management depends on the ability to relate patient results to prior results or to absolute values in clinical practice guidelines. To do this, those results need to be comparable across time and methods, either by producing the same value across methods and test versions or by using reliable and stable conversions. Universally available standards and reference materials specific to quantitative molecular technologies are critical to this process but are few in number. This review describes recent history in the establishment of international standards for nucleic acid test development, organizations involved in current efforts, and future issues and initiatives. PMID:20075208

Clinical grade adult stem cell banking

PubMed Central

Thirumala, Sreedhar; Goebel, W Scott

2009-01-01

There has been a great deal of scientific interest recently generated by the potential therapeutic applications of adult stem cells in human care but there are several challenges regarding quality and safety in clinical applications and a number of these challenges relate to the processing and banking of these cells ex-vivo. As the number of clinical trials and the variety of adult cells used in regenerative therapy increases, safety remains a primary concern. This has inspired many nations to formulate guidelines and standards for the quality of stem cell collection, processing, testing, banking, packaging and distribution. Clinically applicable cryopreservation and banking of adult stem cells offers unique opportunities to advance the potential uses and widespread implementation of these cells in clinical applications. Most current cryopreservation protocols include animal serum proteins and potentially toxic cryoprotectant additives (CPAs) that prevent direct use of these cells in human therapeutic applications. Long term cryopreservation of adult stem cells under good manufacturing conditions using animal product free solutions is critical to the widespread clinical implementation of ex-vivo adult stem cell therapies. Furthermore, to avoid any potential cryoprotectant related complications, reduced CPA concentrations and efficient post-thaw washing to remove CPA are also desirable. The present review focuses on the current strategies and important aspects of adult stem cell banking for clinical applications. These include current good manufacturing practices (cGMPs), animal protein free freezing solutions, cryoprotectants, freezing & thawing protocols, viability assays, packaging and distribution. The importance and benefits of banking clinical grade adult stem cells are also discussed. PMID:20046678

Instructional Internships: Improving the Teaching and Learning Experience for Students, Interns, and Faculty

ERIC Educational Resources Information Center

Hemmerich, Abby L.; Hoepner, Jerry K.; Samelson, Vicki M.

2015-01-01

Students training for clinical careers must acquire skills for teaching clients, their families, and fellow professionals. Guidelines for training programs in Communication Sciences and Disorders (Speech-Language Pathology), however, do not currently include standards for pedagogy. The aim of this study was to measure changes in undergraduate…

42 CFR 485.610 - Condition of participation: Status and location.

Code of Federal Regulations, 2014 CFR

2014-10-01

...— (i) Is licensed by the State as a health clinic or a health center; (ii) Was a hospital that was... PROVIDERS Conditions of Participation: Critical Access Hospitals (CAHs) § 485.610 Condition of participation: Status and location. (a) Standard: Status. The facility is— (1) A currently participating hospital that...

42 CFR 485.610 - Condition of participation: Status and location.

Code of Federal Regulations, 2011 CFR

2011-10-01

...— (i) Is licensed by the State as a health clinic or a health center; (ii) Was a hospital that was... PROVIDERS Conditions of Participation: Critical Access Hospitals (CAHs) § 485.610 Condition of participation: Status and location. (a) Standard: Status. The facility is— (1) A currently participating hospital that...

42 CFR 485.610 - Condition of participation: Status and location.

Code of Federal Regulations, 2013 CFR

2013-10-01

...— (i) Is licensed by the State as a health clinic or a health center; (ii) Was a hospital that was... PROVIDERS Conditions of Participation: Critical Access Hospitals (CAHs) § 485.610 Condition of participation: Status and location. (a) Standard: Status. The facility is— (1) A currently participating hospital that...

42 CFR 485.610 - Condition of participation: Status and location.

Code of Federal Regulations, 2012 CFR

2012-10-01

...— (i) Is licensed by the State as a health clinic or a health center; (ii) Was a hospital that was... PROVIDERS Conditions of Participation: Critical Access Hospitals (CAHs) § 485.610 Condition of participation: Status and location. (a) Standard: Status. The facility is— (1) A currently participating hospital that...

Patient Outcomes | Center for Cancer Research

Cancer.gov

Patient Outcomes Earlier this year, the CBTC sent out a survey to capture the landscape of canine brain tumors in North America. This project was conceived in order to better define the current standards amongst veterinarians in diagnosis, treatment and management of canine brain tumor patients to support future opportunities for translational and clinical studies. The survey

Standardized definitions and clinical endpoints in carotid artery and supra-aortic trunk revascularization trials.

PubMed

Nedeltchev, Krassen; Pattynama, Peter M; Biaminoo, Giancarlo; Diehm, Nicolas; Jaff, Michael R; Hopkins, L Nelson; Ramee, Stephen; van Sambeek, Marc; Talen, Aly; Vermassen, Frank; Cremonesi, Alberto

2010-09-01

Endovascular therapy has emerged as a promising alternative to open surgery for stroke prevention in patients with obstructive disease of the supra-aortic arteries. Although most previous studies have used similar safety and efficacy endpoints, differences in definitions, timing of assessments, and standards of reporting have hampered direct comparisons across various trials. The DEFINE group, an informal collaboration of multidisciplinary physicians, involved in the therapy of patients with obstructive disease of the supra-aortic arteries in Europe and the United States reviewed the current literature and, after extensive correspondence and meetings, proposed the definitions outlined in the present manuscript. Three meetings including all authors of the manuscript, along with representatives of the United States Food and Drug Administration (FDA) and commercial device manufacturers were held in Barcelona, Spain, in May 2008, in Munich, Germany, in July 2008, and in New York in November 2008. The proposed definitions encompass baseline clinical and anatomic characteristics, clinical and radiologic outcomes, complications, standards of reporting, and timing of assessment. Considering the broad consensus between the multidisciplinary scientific members and the regulatory authorities, the proposed definitions are expected to find adoption in future clinical investigations. These definitions can be applied to both endovascular and open surgery trials and will allow reliable comparisons between these two revascularization methods.

Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial): study protocol for a randomised controlled trial.

PubMed

Martin, Naomi H; Ibrahim, Fowzia; Tom, Brian; Galloway, James; Wailoo, Allan; Tosh, Jonathan; Lempp, Heidi; Prothero, Louise; Georgopoulou, Sofia; Sturt, Jackie; Scott, David L

2017-12-08

Uncontrolled active rheumatoid arthritis can lead to increasing disability and reduced quality of life over time. 'Treating to target' has been shown to be effective in active established disease and also in early disease. However, there is a lack of nationally agreed treatment protocols for patients with established rheumatoid arthritis who have intermediate disease activity. This trial is designed to investigate whether intensive management of disease leads to a greater number of remissions at 12 months. Levels of disability and quality of life, and acceptability and cost-effectiveness of the intervention will also be examined. The trial is a 12-month, pragmatic, randomised, open-label, two-arm, parallel-group, multicentre trial undertaken at specialist rheumatology centres across England. Three hundred and ninety-eight patients with established rheumatoid arthritis will be recruited. They will currently have intermediate disease activity (disease activity score for 28 joints assessed using an erythrocyte sedimentation rate of 3.2 to 5.1 with at least three active joints) and will be taking at least one disease-modifying anti-rheumatic drug. Participants will be randomly selected to receive intensive management or standard care. Intensive management will involve monthly clinical reviews with a specialist health practitioner, where drug treatment will be optimised and an individualised treatment support programme delivered based on several principles of motivational interviewing to address identified problem areas, such as pain, fatigue and adherence. Standard care will follow standard local pathways and will be in line with current English guidelines from the National Institute for Health and Clinical Excellence. Patients will be assessed initially and at 6 and 12 months through self-completed questionnaires and clinical evaluation. The trial will establish whether the known benefits of intensive treatment strategies in active rheumatoid arthritis are also seen in patients with established rheumatoid arthritis who have moderately active disease. It will evaluate both the clinical and cost-effectiveness of intensive treatment. Current Controlled Trials, ID: ISRCTN70160382 . Registered on 16 January 2014.

Review of Virtual Reality Treatment in Psychiatry: Evidence Versus Current Diffusion and Use.

PubMed

Mishkind, Matthew C; Norr, Aaron M; Katz, Andrea C; Reger, Greg M

2017-09-18

This review provides an overview of the current evidence base for and clinical applications of the use of virtual reality (VR) in psychiatric practice, in context of recent technological developments. The use of VR in psychiatric practice shows promise with much of the research demonstrating clinical effectiveness for conditions including post-traumatic stress disorder, anxiety and phobias, chronic pain, rehabilitation, and addictions. However, more research is needed before the use of VR is considered a clinical standard of practice in some areas. The recent release of first generation consumer VR products signals a change in the viability of further developing VR systems and applications. As applications increase so will the need for good quality research to best understand what makes VR effective, and when VR is not appropriate for clinical services. As the field progresses, it is hopeful that the flexibility afforded by this technology will yield superior outcomes and a better understanding of the underlying mechanisms impacting those outcomes.

The assessment and treatment of prosodic disorders and neurological theories of prosody.

PubMed

Diehl, Joshua J; Paul, Rhea

2009-08-01

In this article, we comment on specific aspects of Peppé (Peppé, 2009). In particular, we address the assessment and treatment of prosody in clinical settings and discuss current theory on neurological models of prosody. We argue that in order for prosodic assessment instruments and treatment programs to be clinical effective, we need assessment instruments that: (1) have a representative normative comparison sample and strong psychometric properties; (2) are based on empirical information regarding the typical sequence of prosodic acquisition and are sensitive to developmental change; (3) meaningfully subcategorize various aspects of prosody; (4) use tasks that have ecological validity; and (5) have clinical properties, such as length and ease of administration, that allow them to become part of standard language assessment batteries. In addition, we argue that current theories of prosody processing in the brain are moving toward network models that involve multiple brain areas and are crucially dependent on cortical communication. The implications of these observations for future research and clinical practice are outlined.

Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia.

PubMed

Teipel, Stefan; König, Alexandra; Hoey, Jesse; Kaye, Jeff; Krüger, Frank; Robillard, Julie M; Kirste, Thomas; Babiloni, Claudio

2018-06-21

Cognitive function is an important end point of treatments in dementia clinical trials. Measuring cognitive function by standardized tests, however, is biased toward highly constrained environments (such as hospitals) in selected samples. Patient-powered real-world evidence using information and communication technology devices, including environmental and wearable sensors, may help to overcome these limitations. This position paper describes current and novel information and communication technology devices and algorithms to monitor behavior and function in people with prodromal and manifest stages of dementia continuously, and discusses clinical, technological, ethical, regulatory, and user-centered requirements for collecting real-world evidence in future randomized controlled trials. Challenges of data safety, quality, and privacy and regulatory requirements need to be addressed by future smart sensor technologies. When these requirements are satisfied, these technologies will provide access to truly user relevant outcomes and broader cohorts of participants than currently sampled in clinical trials. Copyright © 2018. Published by Elsevier Inc.

A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

PubMed

Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

2007-09-01

Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base.

Advanced endoscopic imaging in gastric neoplasia and preneoplasia

PubMed Central

Lee, Jonathan W J; Lim, Lee Guan; Yeoh, Khay Guan

2017-01-01

Conventional white light endoscopy remains the current standard in routine clinical practice for early detection of gastric cancer. However, it may not accurately diagnose preneoplastic gastric lesions. The technological advancements in the field of endoscopic imaging for gastric lesions are fast growing. This article reviews currently available advanced endoscopic imaging modalities, in particular chromoendoscopy, narrow band imaging and confocal laser endomicroscopy, and their corresponding evidence shown to improve diagnosis of preneoplastic gastric lesions. Raman spectrometry and polarimetry are also introduced as promising emerging technologies. PMID:28176895

[Laboratory diagnosis of mucormycosis].

PubMed

Garcia-Hermoso, Dea

2013-03-01

Mucormycosis are deep infections caused by ubiquitous filamentous fungi of the order of Mucorales. The disease occurs mostly in immunocompromised, diabetic or solid organ transplant recipients. There are currently no specific diagnostic guidelines for mucormycosis. The histological examination and culture of the clinical sample remain the most useful approaches for diagnosis. Furthermore, alternative methods to the fungal culture are yet to be standardized. Here we review the current microbiological approaches used for the diagnosis and identification of Mucorales. © 2013 médecine/sciences – Inserm / SRMS.

Risk stratification of childhood medulloblastoma in the molecular era: the current consensus.

PubMed

Ramaswamy, Vijay; Remke, Marc; Bouffet, Eric; Bailey, Simon; Clifford, Steven C; Doz, Francois; Kool, Marcel; Dufour, Christelle; Vassal, Gilles; Milde, Till; Witt, Olaf; von Hoff, Katja; Pietsch, Torsten; Northcott, Paul A; Gajjar, Amar; Robinson, Giles W; Padovani, Laetitia; André, Nicolas; Massimino, Maura; Pizer, Barry; Packer, Roger; Rutkowski, Stefan; Pfister, Stefan M; Taylor, Michael D; Pomeroy, Scott L

2016-06-01

Historical risk stratification criteria for medulloblastoma rely primarily on clinicopathological variables pertaining to age, presence of metastases, extent of resection, histological subtypes and in some instances individual genetic aberrations such as MYC and MYCN amplification. In 2010, an international panel of experts established consensus defining four main subgroups of medulloblastoma (WNT, SHH, Group 3 and Group 4) delineated by transcriptional profiling. This has led to the current generation of biomarker-driven clinical trials assigning WNT tumors to a favorable prognosis group in addition to clinicopathological criteria including MYC and MYCN gene amplifications. However, outcome prediction of non-WNT subgroups is a challenge due to inconsistent survival reports. In 2015, a consensus conference was convened in Heidelberg with the objective to further refine the risk stratification in the context of subgroups and agree on a definition of risk groups of non-infant, childhood medulloblastoma (ages 3-17). Published and unpublished data over the past 5 years were reviewed, and a consensus was reached regarding the level of evidence for currently available biomarkers. The following risk groups were defined based on current survival rates: low risk (>90 % survival), average (standard) risk (75-90 % survival), high risk (50-75 % survival) and very high risk (<50 % survival) disease. The WNT subgroup and non-metastatic Group 4 tumors with whole chromosome 11 loss or whole chromosome 17 gain were recognized as low-risk tumors that may qualify for reduced therapy. High-risk strata were defined as patients with metastatic SHH or Group 4 tumors, or MYCN-amplified SHH medulloblastomas. Very high-risk patients are Group 3 with metastases or SHH with TP53 mutation. In addition, a number of consensus points were reached that should be standardized across future clinical trials. Although we anticipate new data will emerge from currently ongoing and recently completed clinical trials, this consensus can serve as an outline for prioritization of certain molecular subsets of tumors to define and validate risk groups as a basis for future clinical trials.

Risk stratification of childhood medulloblastoma in the molecular era: The Current Consensus

PubMed Central

Ramaswamy, Vijay; Remke, Marc; Bouffet, Eric; Bailey, Simon; Clifford, Steven C.; Doz, Francois; Kool, Marcel; Dufour, Christelle; Vassal, Gilles; Milde, Till; Witt, Olaf; von Hoff, Katja; Pietsch, Torsten; Northcott, Paul A.; Gajjar, Amar; Robinson, Giles W.; Padovani, Laetitia; André, Nicolas; Massimino, Maura; Pizer, Barry; Packer, Roger; Rutkowski, Stefan; Pfister, Stefan M.; Taylor, Michael D.; Pomeroy, Scott L.

2016-01-01

Historical risk stratification criteria for medulloblastoma rely primarily on clinicopathological variables pertaining to age, presence of metastases, extent of resection, histological subtypes and in some instances individual genetic aberrations such as MYC and MYCN amplification. In 2010, an international panel of experts established consensus defining four main subgroups of medulloblastoma (WNT, SHH, Group 3 and Group 4) delineated by transcriptional profiling. This has led to the current generation of biomarker-driven clinical trials assigning WNT tumors to a favorable prognosis group in addition to clinicopathological criteria including MYC and MYCN gene amplifications. However, outcome prediction of non-WNT subgroups is a challenge due to inconsistent survival reports. In 2015, a consensus conference was convened in Heidelberg with the objective to further refine the risk stratification in the context of subgroups and agree on a definition of risk groups of non-infant, childhood medulloblastoma (ages 3–17). Published and unpublished data over the past five years were reviewed, and a consensus was reached regarding the level of evidence for currently available biomarkers. The following risk groups were defined based on current survival rates: low risk (>90% survival), average (standard) risk (75–90% survival), high risk (50–75% survival) and very high risk (<50% survival) disease. The WNT subgroup and non-metastatic Group 4 tumors with whole chromosome 11 loss or whole chromosome 17 gain were recognized as low risk tumors that may qualify for reduced therapy. High-risk strata were defined as patients with metastatic SHH or Group 4 tumors, or MYCN amplified SHH medulloblastomas. Very high-risk patients are Group 3 with metastases or SHH with TP53 mutation. In addition, a number of consensus points were reached that should be standardized across future clinical trials. Although we anticipate new data will emerge from currently ongoing and recently completed clinical trials, this consensus can serve as an outline for prioritization of certain molecular subsets of tumors to define and validate risk groups as a basis for future clinical trials. PMID:27040285

Treating cutaneous leishmaniasis patients in Kabul, Afghanistan: cost-effectiveness of an operational program in a complex emergency setting

PubMed Central

Reithinger, Richard; Coleman, Paul G

2007-01-01

Background Although Kabul city, Afghanistan, is currently the worldwide largest focus of cutaneous leishmaniasis (CL) with an estimated 67,500 cases, donor interest in CL has been comparatively poor because the disease is non-fatal. Since 1998 HealthNet TPO (HNTPO) has implemented leishmaniasis diagnosis and treatment services in Kabul and in 2003 alone 16,390 were treated patients in six health clinics in and around the city. The aim of our study was to calculate the cost-effectiveness for the implemented treatment regimen of CL patients attending HNTPO clinics in the Afghan complex emergency setting. Methods Using clinical and cost data from the on-going operational HNTPO program in Kabul, published and unpublished sources, and discussions with researchers, we developed models that included probabilistic sensitivity analysis to calculate ranges for the cost per disability adjusted life year (DALY) averted for implemented CL treatment regimen. We calculated the cost-effectiveness of intralesional and intramuscular administration of the pentavalent antimonial drug sodium stibogluconate, HNTPO's current CL 'standard treatment'. Results The cost of the standard treatment was calculated to be US$ 27 (95% C.I. 20 – 36) per patient treated and cured. The cost per DALY averted per patient cured with the standard treatment was estimated to be approximately US$ 1,200 (761 – 1,827). Conclusion According to WHO-CHOICE criteria, treatment of CL in Kabul, Afghanistan, is not a cost-effective health intervention. The rationale for treating CL patients in Afghanistan and elsewhere is discussed. PMID:17263879

An update on 'dose calibrator' settings for nuclides used in nuclear medicine.

PubMed

Bergeron, Denis E; Cessna, Jeffrey T

2018-06-01

Most clinical measurements of radioactivity, whether for therapeutic or imaging nuclides, rely on commercial re-entrant ionization chambers ('dose calibrators'). The National Institute of Standards and Technology (NIST) maintains a battery of representative calibrators and works to link calibration settings ('dial settings') to primary radioactivity standards. Here, we provide a summary of NIST-determined dial settings for 22 radionuclides. We collected previously published dial settings and determined some new ones using either the calibration curve method or the dialing-in approach. The dial settings with their uncertainties are collected in a comprehensive table. In general, current manufacturer-provided calibration settings give activities that agree with National Institute of Standards and Technology standards to within a few percent.

[Precision Oncology and "Molecular Tumor Boards" - Concepts, Chances and Challenges].

PubMed

Holch, Julian Walter; Westphalen, Christoph Benedikt; Hiddemann, Wolfgang; Heinemann, Volker; Jung, Andreas; Metzeler, Klaus Hans

2017-11-01

Recent developments in genomics allow a more and more comprehensive genetic analysis of human malignancies, and have sparked hopes that this will contribute to the development of novel targeted, effective and well-tolerated therapies.While targeted therapies have improved the prognosis of many cancer patients with certain tumor types, "precision oncology" also brings along new challenges. Highly personalized treatment strategies require new strategies for clinical trials and translation into routine clinical practice. We review the current technical approaches for "universal genetic testing" in cancer, and potential pitfalls in the interpretation of such data. We then provide an overview of the available evidence supporting treatment strategies based on extended genetic analysis. Based on the available data, we conclude that "precision oncology" approaches that go beyond the current standard of care should be pursued within the framework of an interdisciplinary "molecular tumor board", and preferably within clinical trials. © Georg Thieme Verlag KG Stuttgart · New York.

Advances in the management of follicular lymphoma.

PubMed

Seiler, Till M; Hiddemann, Wolfgang

2012-11-01

Antibody-based therapy has revolutionized treatment strategies in follicular lymphoma. This review focuses on current standards and recent innovations in the management of the disease. Understanding the mechanism of action of antibodies led to the development of next generation CD20 antibodies, antibodies targeting other molecules and bispecific antibodies. With obinutuzumab, a promising next generation of CD20 antibodies has entered phase III of clinical trials. The bispecific T-cell engager blinatumomab combines targeted therapy with immunologic activation of T cells exerting cytotoxic activity on the target cells. Apart from antibodies, small molecules targeting key pathways in lymphoma have shown promising activity in vitro and are currently in clinical development. A wealth of new substances has entered various stages of clinical trials and has yet to show superiority over rituximab-based immunochemotherapy. Intelligent therapeutic regimens containing these drugs have to be developed. Large randomized trials comparing promising treatment options are urgently needed.

Return of Individual Research Results and Incidental Findings in the Clinical Trials Cooperative Group Setting

PubMed Central

Ferriere, Michael; Van Ness, Brian

2013-01-01

The NCI funded cooperative group cancer clinical trial system develops experimental therapies and often collects patient samples for correlative research. The Cooperative Group Bank (CGB) system maintains biobanks with a current policy not to return research results to individuals. An online survey was created, and 10 directors of CGBs completed the surveys asking about understanding and attitudes in changing policies to consider return of Incidental Findings (IFs) and Individual Research Results (IRRs) of health significance. The potential impact of the ten consensus recommendations of Wolf et al. presented in this issue are examined. Re-identification of samples is often not problematic; however, changes to the current banking and clinical trial systems would require significant effort to fulfill an obligation of recontact of subjects. Additional resources, as well as a national advisory board would be required to standardize implementation. PMID:22382800

Identification of psychological comorbidity in TMD-patients.

PubMed

Ismail, F; Eisenburger, M; Lange, K; Schneller, T; Schwabe, L; Strempel, J; Stiesch, M

2016-05-01

The aim of the current study was to access the prevalence of depression among patients with Temporomandibular Joint Disorder (TMD) compared to patients with no current TMD. Patients (92) and controls (90) answered questionnaires on subjective pain, severity of chronic pain, jaw disability, emotional well-being and depression, and a clinical examination was performed. Temporomandibular Joint Disorder patients reported higher disability of jaw function, compared to controls (p<0.001). The myoarthopathy subgroup (67.4%) had slightly more jaw disability than the myopathy subgroup (p>0.05). While 51% of TMD patients reported poor emotional well-being, only 7.8% of controls were affected (p<0.001). Clinical symptoms of depression were reported by 16% of TMD patients and not in the controls (p<0.001). Among TMD patients, a higher prevalence of depression was observed in the myopathy subgroup. A regular screening for psychological problems, using standardized questionnaires, should be integrated in clinical examination of TMD patients.

Setting performance standards for medical practice: a theoretical framework.

PubMed

Southgate, L; Hays, R B; Norcini, J; Mulholland, H; Ayers, B; Woolliscroft, J; Cusimano, M; McAvoy, P; Ainsworth, M; Haist, S; Campbell, M

2001-05-01

The assessment of performance in the real world of medical practice is now widely accepted as the goal of assessment at the postgraduate level. This is largely a validity issue, as it is recognised that tests of knowledge and in clinical simulations cannot on their own really measure how medical practitioners function in the broader health care system. However, the development of standards for performance-based assessment is not as well understood as in competency assessment, where simulations can more readily reflect narrower issues of knowledge and skills. This paper proposes a theoretical framework for the development of standards that reflect the more complex world in which experienced medical practitioners work. The paper reflects the combined experiences of a group of education researchers and the results of literature searches that included identifying current health system data sources that might contribute information to the measurement of standards. Standards that reflect the complexity of medical practice may best be developed through an "expert systems" analysis of clinical conditions for which desired health care outcomes reflect the contribution of several health professionals within a complex, three-dimensional, contextual model. Examples of the model are provided, but further work is needed to test validity and measurability.

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

PubMed

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

2015-04-01

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

Concussion management in US college football: progress and pitfalls

PubMed Central

Kroshus, Emily

2015-01-01

Reducing the frequency and severity of concussions from sport is an important issue in public health currently addressed by a multifaceted approach. Given the large number of participants and the comparatively high risk of injury, American football is an important sport to consider when examining concussion management practices. Focusing on American football at the collegiate level, this manuscript describes current research regarding concussion epidemiology, policy, implementation of clinical diagnosis, management and return-to-play standards and athlete concussion education. Although American collegiate sports leagues have put forth concussion-related policies in recent years, the implementation of these policies and related effects on athlete concussion education, clinical management of concussion and ultimately athlete health outcomes are not well understood. Additional research is needed. PMID:27064258

Exogenous and endogenous hormones and breast cancer

PubMed Central

ChenMD, Wendy Y.

2008-01-01

Exposure to higher levels of both exogenous and endogenous hormone is associated with breast cancer risk. Because of the association between breast cancer and HRT, only the minimal duration of HRT use is recommended for symptom control, and it is not recommended for chronic disease management. Current research issues include the role of progestins, other types of HRT, duration of unopposed estrogen use, and characteristics of cancers that develop on HRT. Circulating sex steroid levels are associated with breast cancer risk, but multiple issues need to be addressed before they are used routinely in clinical practice. Current research issues include measurement of levels for routine clinical practice, integration with standard breast cancer risk models and genetic polymorphism data, and applicability to estrogen-receptor-negative cancers. PMID:18971119

MO-A-BRC-02: TG167 Report - Detailed Description

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rivard, M.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

MO-A-BRC-01: TG167 Report - Introduction

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nath, R.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

What can Natural Language Processing do for Clinical Decision Support?

PubMed Central

Demner-Fushman, Dina; Chapman, Wendy W.; McDonald, Clement J.

2009-01-01

Computerized Clinical Decision Support (CDS) aims to aid decision making of health care providers and the public by providing easily accessible health-related information at the point and time it is needed. Natural Language Processing (NLP) is instrumental in using free-text information to drive CDS, representing clinical knowledge and CDS interventions in standardized formats, and leveraging clinical narrative. The early innovative NLP research of clinical narrative was followed by a period of stable research conducted at the major clinical centers and a shift of mainstream interest to biomedical NLP. This review primarily focuses on the recently renewed interest in development of fundamental NLP methods and advances in the NLP systems for CDS. The current solutions to challenges posed by distinct sublanguages, intended user groups, and support goals are discussed. PMID:19683066

Management of tinnitus in English NHS audiology departments: an evaluation of current practice

PubMed Central

Hoare, Derek J; Gander, Phillip E; Collins, Luke; Smith, Sandra; Hall, Deborah A

2012-01-01

Rationale, aim and objective In 2009, the UK Department of Health formalized recommended National Health Service practices for the management of tinnitus from primary care onwards. It is timely therefore to evaluate the perceived practicality, utility and impact of those guidelines in the context of current practice. Methods We surveyed current practice by posting a 36-item questionnaire to all audiology and hearing therapy staff that we were able to identify as being involved in tinnitus patient care in England. Results In total, 138 out of 351 clinicians responded (39% response rate). The findings indicate a consensus opinion that management should be tailored to individual symptom profiles but that there is little standardization of assessment procedures or tools in use. Conclusions While the lack of standardized practice might provide flexibility to meet local demand, it has drawbacks. It makes it difficult to ascertain key standards of best practice, it complicates the process of clinical audit, it implies unequal patient access to care, and it limits the implementation of translational research outcomes. We recommend that core elements of practice should be standardized, including use of a validated tinnitus questionnaires and an agreed pathway for decision making to better understand the rationale for management strategies offered. PMID:21087449

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

PubMed

Senft, Jonas D; Warschkow, Rene; Diener, Markus K; Tarantino, Ignazio; Steinemann, Daniel C; Lamm, Sebastian; Simon, Thomas; Zerz, Andreas; Müller-Stich, Beat P; Linke, Georg R

2014-11-20

Natural orifice transluminal endoscopic surgery (NOTES) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma. The potential benefits are expected to be less postoperative pain, faster convalescence, and reduced risk for incisional hernias and wound infections compared to conventional methods. Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES, and transvaginal access is currently the most frequent clinically applied route for NOTES procedures. However, despite increasing clinical application, no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard. The TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection. Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible. The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale (VAS). Secondary outcomes include daily pain intensity and analgesic use, patient mobility, intraoperative complications, morbidity, length of stay, quality of life, and sexual function. Follow-up visits are scheduled 3, 12, and 36 months after surgery. A total sample size of 58 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat (ITT) principle. The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting. The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the current surgical standard for sigmoid resection. The trial protocol was registered in the German Clinical Trials Register ( DRKS00005995) on March 27, 2014.

WE-E-12A-01: Medical Physics 1.0 to 2.0: MRI, Displays, Informatics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pickens, D; Flynn, M; Peck, D

Medical Physics 2.0 is a bold vision for an existential transition of clinical imaging physics in face of the new realities of value-based and evidence-based medicine, comparative effectiveness, and meaningful use. It speaks to how clinical imaging physics can expand beyond traditional insular models of inspection and acceptance testing, oriented toward compliance, towards team-based models of operational engagement, prospective definition and assurance of effective use, and retrospective evaluation of clinical performance. Organized into four sessions of the AAPM, this particular session focuses on three specific modalities as outlined below. MRI 2.0: This presentation will look into the future of clinicalmore » MR imaging and what the clinical medical physicist will need to be doing as the technology of MR imaging evolves. Many of the measurement techniques used today will need to be expanded to address the advent of higher field imaging systems and dedicated imagers for specialty applications. Included will be the need to address quality assurance and testing metrics for multi-channel MR imagers and hybrid devices such as MR/PET systems. New pulse sequences and acquisition methods, increasing use of MR spectroscopy, and real-time guidance procedures will place the burden on the medical physicist to define and use new tools to properly evaluate these systems, but the clinical applications must be understood so that these tools are use correctly. Finally, new rules, clinical requirements, and regulations will mean that the medical physicist must actively work to keep her/his sites compliant and must work closely with physicians to ensure best performance of these systems. Informatics Display 1.0 to 2.0: Medical displays are an integral part of medical imaging operation. The DICOM and AAPM (TG18) efforts have led to clear definitions of performance requirements of monochrome medical displays that can be followed by medical physicists to ensure proper performance. However, effective implementation of that oversight has been challenging due to the number and extend of medical displays in use at a facility. The advent of color display and mobile displays has added additional challenges to the task of the medical physicist. This informatics display lecture first addresses the current display guidelines (the 1.0 paradigm) and further outlines the initiatives and prospects for color and mobile displays (the 2.0 paradigm). Informatics Management 1.0 to 2.0: Imaging informatics is part of every radiology practice today. Imaging informatics covers everything from the ordering of a study, through the data acquisition and processing, display and archiving, reporting of findings and the billing for the services performed. The standardization of the processes used to manage the information and methodologies to integrate these standards is being developed and advanced continuously. These developments are done in an open forum and imaging organizations and professionals all have a part in the process. In the Informatics Management presentation, the flow of information and the integration of the standards used in the processes will be reviewed. The role of radiologists and physicists in the process will be discussed. Current methods (the 1.0 paradigm) and evolving methods (the 2.0 paradigm) for validation of informatics systems function will also be discussed. Learning Objectives: Identify requirements for improving quality assurance and compliance tools for advanced and hybrid MRI systems. Identify the need for new quality assurance metrics and testing procedures for advanced systems. Identify new hardware systems and new procedures needed to evaluate MRI systems. Understand the components of current medical physics expectation for medical displays. Understand the role and prospect fo medical physics for color and mobile display devices. Understand different areas of imaging informatics and the methodology for developing informatics standards. Understand the current status of informatics standards and the role of physicists and radiologists in the process, and the current technology for validating the function of these systems.« less

Endometriosis: Survey of Current Diagnostic and Therapeutic Options and Latest Research Work

PubMed Central

Juhasz-Böss, I.; Laschke, M. W.; Müller, F.; Rosenbaum, P.; Baum, S.; Solomayer, E. F.; Ulrich, U.

2014-01-01

Endometriosis is one of the most frequent benign diseases in women of child-bearing age. The main symptoms are chronic upper abdominal pain and infertility. However, the aetiology and pathogenesis of endometriosis are as yet insufficiently clarified. Thus, therapy is mainly symptomatic with laparoscopic surgery being the gold standard. The aim of drug therapy is to achieve a hypo-oestrogenic condition. In cases of severe endometriosis and a desire to have children there is often an indication for assisted reproduction. The present article illustrates almost all current aspects on the diagnosis of and therapy of endometriosis. From the clinical viewpoint, emphasis is placed on the rare cases of deeply infiltrating endometriosis that are, however, accompanied with a high morbidity. Current therapeutic options in cases of infertility are also presented in more detail. Furthermore, special attention is paid to the latest research results from both clinical and basic research fields in order to demonstrate our current knowledge on the pathogenesis and, where possible, potentially related therapeutic options. PMID:25221341

The Residual Risk Reduction Initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia.

PubMed

Fruchart, Jean-Charles; Sacks, Frank; Hermans, Michel P; Assmann, Gerd; Brown, W Virgil; Ceska, Richard; Chapman, M John; Dodson, Paul M; Fioretto, Paola; Ginsberg, Henry N; Kadowaki, Takashi; Lablanche, Jean-Marc; Marx, Nikolaus; Plutzky, Jorge; Reiner, Zeljko; Rosenson, Robert S; Staels, Bart; Stock, Jane K; Sy, Rody; Wanner, Christoph; Zambon, Alberto; Zimmet, Paul

2008-11-17

Despite achieving targets for low-density lipoprotein (LDL) cholesterol, blood pressure, and glycemia in accordance with current standards of care, patients with dyslipidemia remain at high residual risk of vascular events. Atherogenic dyslipidemia, characterized by elevated triglycerides and low levels of high-density lipoprotein (HDL) cholesterol, often with elevated apolipoprotein B and non-HDL cholesterol, is common in patients with established cardiovascular disease (CVD), type 2 diabetes mellitus, or metabolic syndrome and contributes to both macrovascular and microvascular residual risk. However, atherogenic dyslipidemia is largely underdiagnosed and undertreated in clinical practice. The Residual Risk Reduction Initiative (R3i) was established to address this highly relevant clinical issue. The aims of this position paper are (1) to highlight evidence that atherogenic dyslipidemia is associated with residual macrovascular and microvascular risk in patients at high risk for CVD, despite current standards of care for dyslipidemia and diabetes; and (2) to recommend therapeutic intervention for reducing this residual vascular risk supported by evidence and expert consensus. Lifestyle modification with nutrition and exercise is an important, effective, and underutilized first step in reducing residual vascular risk. Therapeutic intervention aimed at achievement of all lipid targets is also often required. Combination lipid-modifying therapy, with the addition of niacin, a fibrate, or omega-3 fatty acids to statin therapy, increases the probability of achieving all lipid goals. Outcomes studies are in progress to evaluate whether these combination treatment strategies translate to a clinical benefit greater than that achieved with statins alone. The R3i highlights the need to address with lifestyle and/or pharmacotherapy the high level of residual risk of CVD events and microvascular complications among patients with dyslipidemia receiving therapy for high levels of LDL cholesterol and for diabetes in accordance with current standards of care.

Vorapaxar: The Current Role and Future Directions of a Novel Protease-Activated Receptor Antagonist for Risk Reduction in Atherosclerotic Disease.

PubMed

Gryka, Rebecca J; Buckley, Leo F; Anderson, Sarah M

2017-03-01

Despite the current standard of care, patients with cardiovascular disease remain at a high risk for recurrent events. Inhibition of thrombin-mediated platelet activation through protease-activated receptor-1 antagonism may provide reductions in atherosclerotic disease beyond those achievable with the current standard of care. Our primary objective is to evaluate the clinical literature regarding the role of vorapaxar (Zontivity™) in the reduction of cardiovascular events in patients with a history of myocardial infarction and peripheral artery disease. In particular, we focus on the potential future directions for protease-activating receptor antagonists in the treatment of a broad range of atherosclerotic diseases. A literature search of PubMed and EBSCO was conducted to identify randomized clinical trials from August 2005 to June 2016 using the search terms: 'vorapaxar', 'SCH 530348', 'protease-activated receptor-1 antagonist', and 'Zontivity™'. Bibliographies were searched and additional resources were obtained. Vorapaxar is a first-in-class, protease-activated receptor-1 antagonist. The Thrombin Receptor Antagonist for Clinical Event Reduction (TRACER) trial did not demonstrate a significant reduction in a broad primary composite endpoint. However, the Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P-TIMI 50) trial examined a more traditional composite endpoint and found a significant benefit with vorapaxar. Vorapaxar significantly increased bleeding compared with standard care. Ongoing trials will help define the role of vorapaxar in patients with peripheral arterial disease, patients with diabetes mellitus, and other important subgroups. The use of multivariate modeling may enable the identification of subgroups with maximal benefit and minimal harm from vorapaxar. Vorapaxar provides clinicians with a novel mechanism of action to further reduce the burden of ischemic heart disease. Identification of patients with a high ischemic risk and low bleeding risk would enable clinicians to maximize the utility of this unique agent.

CpG Methylation Analysis—Current Status of Clinical Assays and Potential Applications in Molecular Diagnostics

PubMed Central

Sepulveda, Antonia R.; Jones, Dan; Ogino, Shuji; Samowitz, Wade; Gulley, Margaret L.; Edwards, Robin; Levenson, Victor; Pratt, Victoria M.; Yang, Bin; Nafa, Khedoudja; Yan, Liying; Vitazka, Patrick

2009-01-01

Methylation of CpG islands in gene promoter regions is a major molecular mechanism of gene silencing and underlies both cancer development and progression. In molecular oncology, testing for the CpG methylation of tissue DNA has emerged as a clinically useful tool for tumor detection, outcome prediction, and treatment selection, as well as for assessing the efficacy of treatment with the use of demethylating agents and monitoring for tumor recurrence. In addition, because CpG methylation occurs early in pre-neoplastic tissues, methylation tests may be useful as markers of cancer risk in patients with either infectious or inflammatory conditions. The Methylation Working Group of the Clinical Practice Committee of the Association of Molecular Pathology has reviewed the current state of clinical testing in this area. We report here our summary of both the advantages and disadvantages of various methods, as well as the needs for standardization and reporting. We then conclude by summarizing the most promising areas for future clinical testing in cancer molecular diagnostics. PMID:19541921

Deep Venous Thrombosis Prophylaxis in Anterior Cruciate Ligament Reconstructive Surgery: What Is the Current State of Practice?

PubMed

Keller, Robert A; Moutzouros, Vasilios; Dines, Joshua S; Bush-Joseph, Charles A; Limpisvasti, Orr

Venous thromboembolism (VTE) is a significant perioperative risk with many common orthopaedic procedures. Currently, there is no standardized recommendation for the use of VTE prophylaxis during anterior cruciate ligament (ACL) reconstruction. This study sought to evaluate the current prophylactic practices of fellowship-trained sports medicine orthopaedic surgeons in the United States. Very few surgeons use perioperative VTE prophylaxis for ACL reconstructive surgery. Survey. Surveys were emailed to the alumni networks of 4 large ACGME-accredited sports medicine fellowship programs. Questions were focused on their current use of chemical and nonchemical VTE prophylaxis. Surveys were completed by 142 surgeons in the United States, yielding a response rate of 32%. Of those who responded, 50.7% stated that they routinely use chemical prophylaxis, with 95.5% of those using aspirin (acetylsalicylic acid [ASA]). There was no standardized dosing protocol, with respondents using ASA 325 mg once (46%) or twice daily (26%) or ASA 81 mg once (18%) or twice (10%) daily. The most common reason for not including chemical prophylaxis within the reconstruction procedure was that it is unnecessary given the low risk of VTE. Physicians also based their prophylaxis regimen more on their own clinical experience than concern for litigation. Half of all sports medicine fellowship-trained surgeons surveyed routinely use chemical VTE prophylaxis after ACL reconstruction, with more than 90% of those using ASA. Of those using ASA, there was no prevailing dosing protocol. For those not using chemical prophylaxis, the most important reason was that it was felt to be unnecessary due to the risks outweighing the benefits. Those who do not regularly use chemical prophylaxis would be willing to, however, if a patient had a personal or family history of clotting disorder or is currently on birth control. Additionally, clinical experience was the primary driver for a current prophylaxis protocol. This survey study evaluating the use of VTE prophylaxis with ACL reconstruction lends clinical insight to the current practice of a large, geographically diverse group of fellowship-trained sports medicine orthopaedic surgeons in the United States.

Comparison of isolated cranberry (Vaccinium macrocarpon Ait.) proanthocyanidins to catechin and procyanidins A2 and B2 for use as standards in the 4-(dimethylamino)cinnamaldehyde assay.

PubMed

Feliciano, Rodrigo P; Shea, Michael P; Shanmuganayagam, Dhanansayan; Krueger, Christian G; Howell, Amy B; Reed, Jess D

2012-05-09

The 4-(dimethylamino)cinnamaldehyde (DMAC) assay is currently used to quantify proanthocyanidin (PAC) content in cranberry products. However, this method suffers from issues of accuracy and precision in the analysis and comparison of PAC levels across a broad range of cranberry products. Current use of procyanidin A2 as a standard leads to an underestimation of PACs content in certain cranberry products, especially those containing higher molecular weight PACs. To begin to address the issue of accuracy, a method for the production of a cranberry PAC standard, derived from an extraction of cranberry (c-PAC) press cake, was developed and evaluated. Use of the c-PAC standard to quantify PAC content in cranberry samples resulted in values that were 2.2 times higher than those determined by procyanidin A2. Increased accuracy is critical for estimating PAC content in relationship to research on authenticity, efficacy, and bioactivity, especially in designing clinical trials for determination of putative health benefits.

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety.

PubMed

Khusid, Marina A; Vythilingam, Meena

2016-09-01

Mindfulness-based interventions (MBIs) have been increasingly utilized in the management of mental health conditions. This first review of a two-part series evaluates the efficacy, mechanism, and safety of mindfulness meditation for mental health conditions frequently seen after return from deployment. Standard databases were searched until August 4, 2015. 52 systematic reviews and randomized clinical trials were included. The Strength of Recommendation (SOR) Taxonomy was used to assess the quality of individual studies and to rate the strength of evidence for each clinical condition. Adjunctive mindfulness-based cognitive therapy is effective for decreasing symptom severity during current depressive episode, and for reducing relapse rate in recovered patients during maintenance phase of depression management (SOR moderate [SOR B]). Adjunctive mindfulness-based stress reduction is effective for improving symptoms, mental health-related quality of life, and mindfulness in veterans with combat post-traumatic stress disorder (PTSD) (SOR B). Currently, there is no sufficient data to recommend MBIs for generalized anxiety disorder (SOR B). MBIs are safe, portable, cost-effective, and can be recommended as an adjunct to standard care or self-management strategy for major depressive disorder and PTSD. Future large, well-designed randomized clinical trials in service members and veterans can help plan for the anticipated increase in demand for behavioral health services. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

Parkinson's disease-related fatigue: A case definition and recommendations for clinical research.

PubMed

Kluger, Benzi M; Herlofson, Karen; Chou, Kelvin L; Lou, Jau-Shin; Goetz, Christopher G; Lang, Anthony E; Weintraub, Daniel; Friedman, Joseph

2016-05-01

Fatigue is one of the most common and disabling symptoms in Parkinson's disease (PD). Since fatigue was first described as a common feature of PD 20 years ago, little progress has been made in understanding its causes or treatment. Importantly, PD patients attending the 2013 World Parkinson Congress voted fatigue as the leading symptom in need of further research. In response, the Parkinson Disease Foundation and ProjectSpark assembled an international team of experts to create recommendations for clinical research to advance this field. The working group identified several areas in which shared standards would improve research quality and foster progress including terminology, diagnostic criteria, and measurement. Terminology needs to (1) clearly distinguish fatigue from related phenomena (eg, sleepiness, apathy, depression); (2) differentiate subjective fatigue complaints from objective performance fatigability; and (3) specify domains affected by fatigue and causal factors. We propose diagnostic criteria for PD-related fatigue to guide participant selection for clinical trials and add rigor to mechanistic studies. Recommendations are made for measurement of subjective fatigue complaints, performance fatigability, and neurophysiologic changes. We also suggest areas in which future research is needed to address methodological issues and validate or optimize current practices. Many limitations in current PD-related fatigue research may be addressed by improving methodological standards, many of which are already being successfully applied in clinical fatigue research in other medical conditions (eg, cancer, multiple sclerosis). © 2016 International Parkinson and Movement Disorder Society. © 2016 International Parkinson and Movement Disorder Society.

Non-invasive prediction of forthcoming cirrhosis-related complications

PubMed Central

Kang, Wonseok; Kim, Seung Up; Ahn, Sang Hoon

2014-01-01

In patients with chronic liver diseases, identification of significant liver fibrosis and cirrhosis is essential for determining treatment strategies, assessing therapeutic response, and stratifying long-term prognosis. Although liver biopsy remains the reference standard for evaluating the extent of liver fibrosis in patients with chronic liver diseases, several non-invasive methods have been developed as alternatives to liver biopsies. Some of these non-invasive methods have demonstrated clinical accuracy for diagnosing significant fibrosis or cirrhosis in many cross-sectional studies with the histological fibrosis stage as a reference standard. However, non-invasive methods cannot be fully validated through cross-sectional studies since liver biopsy is not a perfect surrogate endpoint marker. Accordingly, recent studies have focused on assessing the performance of non-invasive methods through long-term, longitudinal, follow-up studies with solid clinical endpoints related to advanced stages of liver fibrosis and cirrhosis. As a result, current view is that these alternative methods can independently predict future cirrhosis-related complications, such as hepatic decompensation, liver failure, hepatocellular carcinoma, or liver-related death. The clinical role of non-invasive models seems to be shifting from a simple tool for predicting the extent of fibrosis to a surveillance tool for predicting future liver-related events. In this article, we will summarize recent longitudinal studies of non-invasive methods for predicting forthcoming complications related to liver cirrhosis and discuss the clinical value of currently available non-invasive methods based on evidence from the literature. PMID:24627597

A CAD system and quality assurance protocol for bone age assessment utilizing digital hand atlas

NASA Astrophysics Data System (ADS)

Gertych, Arakadiusz; Zhang, Aifeng; Ferrara, Benjamin; Liu, Brent J.

2007-03-01

Determination of bone age assessment (BAA) in pediatric radiology is a task based on detailed analysis of patient's left hand X-ray. The current standard utilized in clinical practice relies on a subjective comparison of the hand with patterns in the book atlas. The computerized approach to BAA (CBAA) utilizes automatic analysis of the regions of interest in the hand image. This procedure is followed by extraction of quantitative features sensitive to skeletal development that are further converted to a bone age value utilizing knowledge from the digital hand atlas (DHA). This also allows providing BAA results resembling current clinical approach. All developed methodologies have been combined into one CAD module with a graphical user interface (GUI). CBAA can also improve the statistical and analytical accuracy based on a clinical work-flow analysis. For this purpose a quality assurance protocol (QAP) has been developed. Implementation of the QAP helped to make the CAD more robust and find images that cannot meet conditions required by DHA standards. Moreover, the entire CAD-DHA system may gain further benefits if clinical acquisition protocol is modified. The goal of this study is to present the performance improvement of the overall CAD-DHA system with QAP and the comparison of the CAD results with chronological age of 1390 normal subjects from the DHA. The CAD workstation can process images from local image database or from a PACS server.

Concussion-assessment and -management techniques used by athletic trainers.

PubMed

Lynall, Robert C; Laudner, Kevin G; Mihalik, Jason P; Stanek, Justin M

2013-01-01

Understanding concussion-assessmment and -management practices that athletic trainers (ATs) currently use will allow clinicians to identify potential strategies for enhancing the quality of care provided to patients. To assess current clinical concussion diagnostic and return-to-participation practices among ATs. Cross-sectional study. Web-based survey. A link to the survey was sent randomly to a convenience sample of 3222 members of the National Athletic Trainers' Association. A total of 1053 (32.7%) certified ATs (experience as an AT = 11.2 ± 9.1 years) responded to the survey. Prospective participants received electronic correspondence informing them of the purpose of the study and providing a link to the Web-based survey instrument. A reminder e-mail was sent approximately 6 weeks later, and the survey remained online for a total of 8 weeks. We collected information on the annual number of concussions assessed and tools employed to diagnose, manage, and safely return an athlete to participation. Descriptive statistics were computed for each variable. Participants reported observing 10.7 ± 11.0 concussions per year. Clinical examination (n = 743, 70.6%) was the most commonly reported means for evaluating and diagnosing concussion. Less than half of our respondents employed the Standardized Assessment of Concussion (n = 467, 44.3%), any variation of the Romberg test (n = 461, 43.8%), and computerized neuropsychological testing (n = 459, 43.6%). Clinical examination (n = 773, 73.4%), return-to-participation guidelines (n = 713, 67.7%), physician recommendation (n = 660, 62.7%), or player self-report (n = 447, 42.5%) contributed to the return-to-participation decisions of ATs. Only 20.8% (n = 219) of ATs reported using all 3 recommended domains of the concussion battery. Our study demonstrated a growth in the number of ATs incorporating objective clinical measures of concussion as a part of their concussion management. Conversely, fewer ATs reported using a standard clinical examination in their concussion assessment. These findings suggest ATs must continue to increase their use of both objective concussion assessment tools and the standard clinical examination.

State of the art of prostatic arterial embolization for benign prostatic hyperplasia.

PubMed

Petrillo, Mario; Pesapane, Filippo; Fumarola, Enrico Maria; Emili, Ilaria; Acquasanta, Marzia; Patella, Francesca; Angileri, Salvatore Alessio; Rossi, Umberto G; Piacentini, Igor; Granata, Antonio Maria; Ierardi, Anna Maria; Carrafiello, Gianpaolo

2018-04-01

Prostatectomy via open surgery or transurethral resection of the prostate (TURP) is the standard treatment for benign prostatic hyperplasia (BPH). Several patients present contraindication for standard approach, individuals older than 60 years with urinary tract infection, strictures, post-operative pain, incontinence or urinary retention, sexual dysfunction, and blood loss are not good candidates for surgery. Prostatic artery embolization (PAE) is emerging as a viable method for patients unsuitable for surgery. In this article, we report results about technical and clinical success and safety of the procedure to define the current status.

Molecular analysis of breast sentinel lymph nodes.

PubMed

Blumencranz, Peter W; Pieretti, Maura; Allen, Kathleen G; Blumencranz, Lisa E

2011-07-01

Lymphatic mapping and sentinel lymph node (SLN) biopsy have become the standard of care for staging the axilla in patients with invasive breast cancer. Current histologic methods for SLN evaluation have limitations, including subjectivity, limited sensitivity, and lack of standardization. The discovery of molecular markers to detect metastases has been reported over the last 2 decades. The authors review the historical development of these markers and the clinical use of one of the molecular platforms in 478 patients at their institution. Controversies and future directions are discussed. Copyright © 2011 Elsevier Inc. All rights reserved.

Mechanisms underlying brain monitoring during anesthesia: limitations, possible improvements, and perspectives

PubMed Central

2016-01-01

Currently, anesthesiologists use clinical parameters to directly measure the depth of anesthesia (DoA). This clinical standard of monitoring is often combined with brain monitoring for better assessment of the hypnotic component of anesthesia. Brain monitoring devices provide indices allowing for an immediate assessment of the impact of anesthetics on consciousness. However, questions remain regarding the mechanisms underpinning these indices of hypnosis. By briefly describing current knowledge of the brain's electrical activity during general anesthesia, as well as the operating principles of DoA monitors, the aim of this work is to simplify our understanding of the mathematical processes that allow for translation of complex patterns of brain electrical activity into dimensionless indices. This is a challenging task because mathematical concepts appear remote from clinical practice. Moreover, most DoA algorithms are proprietary algorithms and the difficulty of exploring the inner workings of mathematical models represents an obstacle to accurate simplification. The limitations of current DoA monitors — and the possibility for improvement — as well as perspectives on brain monitoring derived from recent research on corticocortical connectivity and communication are also discussed. PMID:27066200

Strain analysis in CRT candidates using the novel segment length in cine (SLICE) post-processing technique on standard CMR cine images.

PubMed

Zweerink, Alwin; Allaart, Cornelis P; Kuijer, Joost P A; Wu, LiNa; Beek, Aernout M; van de Ven, Peter M; Meine, Mathias; Croisille, Pierre; Clarysse, Patrick; van Rossum, Albert C; Nijveldt, Robin

2017-12-01

Although myocardial strain analysis is a potential tool to improve patient selection for cardiac resynchronization therapy (CRT), there is currently no validated clinical approach to derive segmental strains. We evaluated the novel segment length in cine (SLICE) technique to derive segmental strains from standard cardiovascular MR (CMR) cine images in CRT candidates. Twenty-seven patients with left bundle branch block underwent CMR examination including cine imaging and myocardial tagging (CMR-TAG). SLICE was performed by measuring segment length between anatomical landmarks throughout all phases on short-axis cines. This measure of frame-to-frame segment length change was compared to CMR-TAG circumferential strain measurements. Subsequently, conventional markers of CRT response were calculated. Segmental strains showed good to excellent agreement between SLICE and CMR-TAG (septum strain, intraclass correlation coefficient (ICC) 0.76; lateral wall strain, ICC 0.66). Conventional markers of CRT response also showed close agreement between both methods (ICC 0.61-0.78). Reproducibility of SLICE was excellent for intra-observer testing (all ICC ≥0.76) and good for interobserver testing (all ICC ≥0.61). The novel SLICE post-processing technique on standard CMR cine images offers both accurate and robust segmental strain measures compared to the 'gold standard' CMR-TAG technique, and has the advantage of being widely available. • Myocardial strain analysis could potentially improve patient selection for CRT. • Currently a well validated clinical approach to derive segmental strains is lacking. • The novel SLICE technique derives segmental strains from standard CMR cine images. • SLICE-derived strain markers of CRT response showed close agreement with CMR-TAG. • Future studies will focus on the prognostic value of SLICE in CRT candidates.

Implementation of clinical research trials using web-based and mobile devices: challenges and solutions.

PubMed

Eagleson, Roy; Altamirano-Diaz, Luis; McInnis, Alex; Welisch, Eva; De Jesus, Stefanie; Prapavessis, Harry; Rombeek, Meghan; Seabrook, Jamie A; Park, Teresa; Norozi, Kambiz

2017-03-17

With the increasing implementation of web-based, mobile health interventions in clinical trials, it is crucial for researchers to address the security and privacy concerns of patient information according to high ethical standards. The full process of meeting these standards is often made more complicated due to the use of internet-based technology and smartphones for treatment, telecommunication, and data collection; however, this process is not well-documented in the literature. The Smart Heart Trial is a single-arm feasibility study that is currently assessing the effects of a web-based, mobile lifestyle intervention for overweight and obese children and youth with congenital heart disease in Southwestern Ontario. Participants receive telephone counseling regarding nutrition and fitness; and complete goal-setting activities on a web-based application. This paper provides a detailed overview of the challenges the study faced in meeting the high standards of our Research Ethics Board, specifically regarding patient privacy. We outline our solutions, successes, limitations, and lessons learned to inform future similar studies; and model much needed transparency in ensuring high quality security and protection of patient privacy when using web-based and mobile devices for telecommunication and data collection in clinical research.

The impact of the EUSCLE Core Set Questionnaire for the assessment of cutaneous lupus erythematosus.

PubMed

Kuhn, A; Patsinakidis, N; Bonsmann, G

2010-08-01

Epidemiological data and standard European guidelines for the diagnosis and treatment of cutaneous lupus erythematosus (CLE) are lacking in the current literature. In order to provide a standardized tool for an extensive consistent data collection, a study group of the European Society of Cutaneous Lupus Erythematosus (EUSCLE) recently developed a Core Set Questionnaire for the assessment of patients with different subtypes of CLE. The EUSCLE Core Set Questionnaire includes six sections on patient data, diagnosis, skin involvement, activity and damage of disease, laboratory analysis, and treatment. An instrument like the EUSCLE Core Set Questionnaire is essential to gain a broad and comparable data collection of patients with CLE from different European centres and to achieve consensus concerning clinical standards for the disease. The data will also be important for further characterization of the different CLE subtypes and the evaluation of therapeutic strategies; moreover, the EUSCLE Core Set Questionnaire might also be useful for the comparison of data in clinical trials. In this review, the impact of the EUSCLE Core Set Questionnaire is discussed in detail with regard to clinical and serological features as well as therapeutic modalities in CLE.

New methods for the assessment of Parkinson's disease (2005 to 2015): A systematic review.

PubMed

Sánchez-Ferro, Álvaro; Elshehabi, Morad; Godinho, Catarina; Salkovic, Dina; Hobert, Markus A; Domingos, Josefa; van Uem, Janet Mt; Ferreira, Joaquim J; Maetzler, Walter

2016-09-01

The past decade has witnessed a highly dynamic and growing expansion of novel methods aimed at improving the assessment of Parkinson's disease with technology (NAM-PD) in laboratory, clinical, and home environments. However, the current state of NAM-PD regarding their maturity, feasibility, and usefulness in assessing the main PD features has not been systematically evaluated. A systematic review of articles published in the field from 2005 to 2015 was performed. Of 9,503 publications identified in PubMed and the Web of Science, 848 full papers were evaluated, and 588 original articles were assessed to evaluate the technological, demographic, clinimetric, and technology transfer readiness parameters of NAM-PD. Of the studies, 65% included fewer than 30 patients, < 50% employed a standard methodology to validate diagnostic tests, 8% confirmed their results in a different dataset, and 87% occurred in a clinic or lab. The axial features domain was the most frequently studied, followed by bradykinesia. Rigidity and nonmotor domains were rarely investigated. Only 6% of the systems reached a technology level that justified the hope of being included in clinical assessments in a useful time period. This systematic evaluation provides an overview of the current options for quantitative assessment of PD and what can be expected in the near future. There is a particular need for standardized and collaborative studies to confirm the results of preliminary initiatives, assess domains that are currently underinvestigated, and better validate the existing and upcoming NAM-PD. © 2016 International Parkinson and Movement Disorder Society. © 2016 International Parkinson and Movement Disorder Society.

Vascular surgical data registries for small computers.

PubMed

Kaufman, J L; Rosenberg, N

1984-08-01

Recent designs for computer-based vascular surgical registries and clinical data bases have employed large centralized systems with formal programming and mass storage. Small computers, of the types created for office use or for word processing, now contain sufficient speed and memory storage capacity to allow construction of decentralized office-based registries. Using a standardized dictionary of terms and a method of data organization adapted to word processing, we have created a new vascular surgery data registry, "VASREG." Data files are organized without programming, and a limited number of powerful logical statements in English are used for sorting. The capacity is 25,000 records with current inexpensive memory technology. VASREG is adaptable to computers made by a variety of manufacturers, and interface programs are available for conversion of the word processor formated registry data into forms suitable for analysis by programs written in a standard programming language. This is a low-cost clinical data registry available to any physician. With a standardized dictionary, preparation of regional and national statistical summaries may be facilitated.

Setting Standards for Reporting and Quantification in Fluorescence-Guided Surgery.

PubMed

Hoogstins, Charlotte; Burggraaf, Jan Jaap; Koller, Marjory; Handgraaf, Henricus; Boogerd, Leonora; van Dam, Gooitzen; Vahrmeijer, Alexander; Burggraaf, Jacobus

2018-05-29

Intraoperative fluorescence imaging (FI) is a promising technique that could potentially guide oncologic surgeons toward more radical resections and thus improve clinical outcome. Despite the increase in the number of clinical trials, fluorescent agents and imaging systems for intraoperative FI, a standardized approach for imaging system performance assessment and post-acquisition image analysis is currently unavailable. We conducted a systematic, controlled comparison between two commercially available imaging systems using a novel calibration device for FI systems and various fluorescent agents. In addition, we analyzed fluorescence images from previous studies to evaluate signal-to-background ratio (SBR) and determinants of SBR. Using the calibration device, imaging system performance could be quantified and compared, exposing relevant differences in sensitivity. Image analysis demonstrated a profound influence of background noise and the selection of the background on SBR. In this article, we suggest clear approaches for the quantification of imaging system performance assessment and post-acquisition image analysis, attempting to set new standards in the field of FI.

Social work practice in the digital age: therapeutic e-mail as a direct practice methodology.

PubMed

Mattison, Marian

2012-07-01

The author addresses the risks and benefits of incorporating therapeutic e-mail communication into clinical social work practice. Consumer demand for online clinical services is growing faster than the professional response. E-mail, when used as an adjunct to traditional meetings with clients, offers distinct advantages and risks. Benefits include the potential to reach clients in geographically remote and underserved communities, enhancing and extending the therapeutic relationship and improving treatment outcomes. Risks include threats to client confidentiality and privacy, liability coverage for practitioners, licensing jurisdiction, and the lack of competency standards for delivering e-mail interventions. Currently, the social work profession does not have adequate instructive guidelines and best-practice standards for using e-mail as a direct practice methodology. Practitioners need (formal) academic training in the techniques connected to e-mail exchanges with clients. The author describes the ethical and legal risks for practitioners using therapeutic e-mail with clients and identifies recommendations for establishing best-practice standards.

Present and future molecular testing of lung carcinoma.

PubMed

Dacic, Sanja; Nikiforova, Marina N

2014-03-01

The rapid development of targeted therapies has tremendously changed clinical management of lung carcinoma patients and set the stage for similar developments in other tumor types. Many studies have been published in the past decade in search for the most acceptable method of assessment for predictors of response to targeted therapies in lung cancer. As a result, several guidelines for molecular testing have been published in a past couple of years. Because of accumulated evidence that targetable drugs show the best efficacy and improved progression survival rates in lung cancer patients whose tumors have a specific genotype, molecular testing for predictors of therapy response has became standard of care. Presently, testing for EGFR mutations and ALK rearrangements in lung adenocarcinoma has been standardized. The landscape of targetable genomic alterations in lung carcinoma is expanding, but none of other potentially targetable biomarkers have been standardized outside of clinical trials. This review will summarize current practice of molecular testing. Future methods in molecular testing of lung carcinoma will be briefly reviewed.

Inhalant abuse: a study from a tertiary care de-addiction clinic.

PubMed

Verma, R; Balhara, Y P S; Deshpande, S N

2011-12-01

Inhalant use has been considered one of the most dangerous forms of substance abuse leading even to serious accidents and death. The current study explored the correlates of inhalant abuse in subjects from a drug de-addiction clinic. The study was conducted at a tertiary-level multi-specialty hospital in India, which entailed a chart review of patients with inhalant abuse / dependence presenting to the clinic over a 2-year period. All the treatment records of the de-addiction clinic were reviewed and information gathered regarding these patients. The study involved the records of 36 subjects, with a mean age of 16 years (standard deviation, 4; range, 11-26 years). Most subjects (86%) were adolescents; three-quarters of whom had no family history of substance abuse. The mean (standard deviation) age of initiation of inhalant use was 14 (4) years. The commonest cause of first use reported by the subjects was experimentation (94%), and 97% of them came to know of inhalant from their inhalant-using friends. These findings provide important information on a relatively under-researched area.

Recommended Implementation of Arterial Spin Labeled Perfusion MRI for Clinical Applications: A consensus of the ISMRM Perfusion Study Group and the European Consortium for ASL in Dementia

PubMed Central

Alsop, David C.; Detre, John A.; Golay, Xavier; Günther, Matthias; Hendrikse, Jeroen; Hernandez-Garcia, Luis; Lu, Hanzhang; MacIntosh, Bradley J.; Parkes, Laura M.; Smits, Marion; van Osch, Matthias J. P.; Wang, Danny JJ; Wong, Eric C.; Zaharchuk, Greg

2014-01-01

This article provides a summary statement of recommended implementations of arterial spin labeling (ASL) for clinical applications. It is a consensus of the ISMRM Perfusion Study Group and the European ‘ASL in Dementia’ consortium, both of whom met to reach this consensus in October 2012 in Amsterdam. Although ASL continues to undergo rapid technical development, we believe that current ASL methods are robust and ready to provide useful clinical information, and that a consensus statement on recommended implementations will help the clinical community to adopt a standardized approach. In this article we describe the major considerations and tradeoffs in implementing an ASL protocol, and provide specific recommendations for a standard approach. Our conclusions are that, as an optimal default implementation we recommend: pseudo-continuous labeling, background suppression, a segmented 3D readout without vascular crushing gradients, and calculation and presentation of both label/control difference images and cerebral blood flow in absolute units using a simplified model. PMID:24715426

Emerging Issues and Future Developments in Capsule Endoscopy

PubMed Central

Slawinski, Piotr R.; Obstein, Keith L.; Valdastri, Pietro

2015-01-01

Capsule endoscopy (CE) has transformed from a research venture into a widely used clinical tool and the primary means for diagnosing small bowel pathology. These orally administered capsules traverse passively through the gastrointestinal tract via peristalsis and are used in the esophagus, stomach, small bowel, and colon. The primary focus of CE research in recent years has been enabling active CE manipulation and extension of the technology to therapeutic functionality; thus, widening the scope of the procedure. This review outlines clinical standards of the technology as well as recent advances in CE research. Clinical capsule applications are discussed with respect to each portion of the gastrointestinal tract. Promising research efforts are presented with an emphasis on enabling active capsule locomotion. The presented studies suggest, in particular, that the most viable solution for active capsule manipulation is actuation of a capsule via exterior permanent magnet held by a robot. Developing capsule procedures adhering to current healthcare standards, such as enabling a tool channel or irrigation in a therapeutic device, is a vital phase in the adaptation of CE in the clinical setting. PMID:26028956

A Scoping Study on the Ethics of Health Systems Research.

PubMed

Bachani, Abdulgafoor M; Rattani, Abbas; Hyder, Adnan A

2016-12-01

Currently, health systems research (HSR) is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees (RECs), as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, there is a need for additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted (of the responses (n=29), no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step (to better understand the current status) towards a larger dialogue on the topic. © 2016 John Wiley & Sons Ltd.

Paediatric rheumatology practice in the UK benchmarked against the British Society for Paediatric and Adolescent Rheumatology/Arthritis and Musculoskeletal Alliance Standards of Care for juvenile idiopathic arthritis.

PubMed

Kavirayani, Akhila; Foster, Helen E

2013-12-01

To describe current clinical practice against the BSPAR/ARMA Standards of Care (SOCs) for children and young people (CYP) with incident JIA. Ten UK paediatric rheumatology centres (including all current centres nationally accredited for paediatric rheumatology higher specialist training) participated in a retrospective case notes review using a pretested pro forma based on the SOC. Data collected per centre included clinical service configuration and the initial clinical care for a minimum of 30 consecutive new patients seen within the previous 2 years and followed up for at least 6 months. A total of 428 CYP with JIA (median age 11 years, range 1-21 years) were included, with complete data available for 73% (311/428). Against the key SOCs, 41% (175/428) were assessed ≤10 weeks from symptom onset, 60% (186/311) ≤4 weeks from referral, 26% (81/311) had eye screening at ≤6 weeks, 83% (282/341) had joint injections at ≤6 weeks, 59% (184/311) were assessed by a nurse specialist at ≤4 weeks and 45% (141/311) were assessed by a physiotherapist at ≤8 weeks. A median of 6% of patients per centre participated in clinical trials. All centres had access to eye screening and prescribed biologic therapies. All had access to a nurse specialist and physiotherapist. Most had access to an occupational therapist (8/10), psychologist (8/10), joint injection lists (general anaesthesia/inhaled analgesia) (9/10) and designated transitional care clinics (7/10). This first description of UK clinical practice in paediatric rheumatology benchmarked against the BSPAR/ARMA SOCs demonstrates variable clinical service delivery. Considerable delay in access to specialist care is evident and this needs to be addressed in order to improve clinical outcomes.

Contribution of Clinical Archetypes, and the Challenges, towards Achieving Semantic Interoperability for EHRs

PubMed Central

Kalra, Dipak; Kobayashi, Shinji

2013-01-01

Objectives The objective is to introduce 'clinical archetype' which is a formal and agreed way of representing clinical information to ensure interoperability across and within Electronic Health Records (EHRs). The paper also aims at presenting the challenges building quality labeled clinical archetypes and the challenges towards achieving semantic interoperability between EHRs. Methods Twenty years of international research, various European healthcare informatics projects and the pioneering work of the openEHR Foundation have led to the following results. Results The requirements for EHR information architectures have been consolidated within ISO 18308 and adopted within the ISO 13606 EHR interoperability standard. However, a generic EHR architecture cannot ensure that the clinical meaning of information from heterogeneous sources can be reliably interpreted by receiving systems and services. Therefore, clinical models called 'clinical archetypes' are required to formalize the representation of clinical information within the EHR. Part 2 of ISO 13606 defines how archetypes should be formally represented. The current challenge is to grow clinical communities to build a library of clinical archetypes and to identify how evidence of best practice and multi-professional clinical consensus should best be combined to define archetypes at the optimal level of granularity and specificity and quality label them for wide adoption. Standardizing clinical terms within EHRs using clinical terminology like Systematized Nomenclature of Medicine Clinical Terms is also a challenge. Conclusions Clinical archetypes would play an important role in achieving semantic interoperability within EHRs. Attempts are being made in exploring the design and adoption challenges for clinical archetypes. PMID:24523993

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

PubMed

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% applying current EUCAST CBPs. Error rates were > 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 Permissions, please email: journals.permissions@oup.com.

Developing accreditation for community based surgery: the Irish experience.

PubMed

Ní Riain, Ailís; Collins, Claire; O'Sullivan, Tony

2018-02-05

Purpose Carrying out minor surgery procedures in the primary care setting is popular with patients, cost effective and delivers at least as good outcomes as those performed in the hospital setting. This paper aims to describe the central role of clinical leadership in developing an accreditation system for general practitioners (GPs) undertaking community-based surgery in the Irish national setting where no mandatory accreditation process currently exists. Design/methodology/approach In all, 24 GPs were recruited to the GP network. Ten pilot standards were developed addressing GPs' experience and training, clinical activity and practice supporting infrastructure and tested, using information and document review, prospective collection of clinical data and a practice inspection visit. Two additional components were incorporated into the project (patient satisfaction survey and self-audit). A multi-modal evaluation was undertaken. A majority of GPs was included at all stages of the project, in line with the principles of action learning. The steering group had a majority of GPs with relevant expertise and representation of all other actors in the minor surgery arena. The GP research network contributed to each stage of the project. The project lead was a GP with minor surgery experience. Quantitative data collected were analysed using Predictive Analytic SoftWare. Krueger's framework analysis approach was used to analyse the qualitative data. Findings A total of 9 GPs achieved all standards at initial review, 14 successfully completed corrective actions and 1 GP did not achieve the required standard. Standards were then amended to reflect findings and a supporting framework was developed. Originality/value The flexibility of the action-learning approach and the clinical leadership design allowed for the development of robust quality standards in a short timeframe.

[Clinical management of child and adolescent psychiatric emergencies in patients with substance abuse disorders].

PubMed

Coronel, Pablo A

2017-01-01

This paper addresses the problem of substance abuse disorders in child and adolescent patients within its frequent psychiatric emergency setting. It describes the clinical features that defne the high complexity of these cases, the current state of knowledge regarding clinical management of child and adolescent psychiatric emergencies in patients with substance abuse disorders, and the available treatment strategies in the metropolitan area of Buenos Aires, Argentina. Finally, this article delves into the existence of a metropolitan addiction treatment network, its community outreach and the obstacles it has to conquer in order to attain the international standards for the treatment of substance abuse disorders.

Portal vein thrombosis in patients with cirrhosis

PubMed Central

von Köckritz, Leona; De Gottardi, Andrea; Praktiknjo, Michael

2017-01-01

Abstract Portal vein thrombosis (PVT) is frequent in patients with liver cirrhosis and possible severe complications such as mesenteric ischemia are rare, but can be life-threatening. However, different aspects of clinical relevance, diagnosis and management of PVT are still areas of uncertainty and investigation in international guidelines. In this article, we elaborate on PVT classification, geographical differences in clinical presentation and standards of diagnosis, and briefly on the current pathophysiological understanding and risk factors. This review considers and highlights the pitfalls of the various treatment approaches and prophylactic treatments. Finally, we review the controversial issue of clinical impact of PVT on prognosis, especially considering liver transplantation and future perspectives. PMID:28533912

Challenges and Recommendations for Placebo Controls in Randomized Trials in Physical and Rehabilitation Medicine

PubMed Central

Fregni, Felipe; Imamura, Marta; Chien, Hsin Fen; Lew, Henry L.; Boggio, Paulo; Kaptchuk, Ted J; Riberto, Marcelo; Hsing, Wu Tu; Battistella, Linamara Rizzo; Furlan, Andrea

2010-01-01

Compared to other specialties, the field of Physical and Rehabilitation Medicine (PRM) has not received the deserved recognition from clinicians and researchers in the scientific community. One of the reasons is the lack of sound evidence to support the traditional PRM treatments. The best way to change this disadvantage is through well-conducted clinical research, such as the standard placebo or sham-controlled randomized clinical trials. Therefore, having placebo groups in clinical trials is essential to improve the level of evidence-based practice in PRM that ultimately translates in a better clinical care. To address the challenges for the use of placebo in PRM randomized clinical trials, and to create useful recommendations, we convened a working group during the inaugural International Symposium in Placebo (February 2009, in Sao Paulo, Brazil) in which the following topics were discussed: (1) current status of randomized clinical trials in PRM, (2) challenges for the use of placebo in PRM, (3) bioethical issues, (4) use of placebo in acupuncture trials and for the treatment of low-back pain, (5) mechanisms of placebo, and (6) insights from other specialties. The current article represents the consensus report from the working group. PMID:20090428

Bibliotherapy for Children with Anxiety Disorders Using Written Materials for Parents: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Rapee, Ronald M.; Abbott, Maree J.; Lyneham, Heidi J.

2006-01-01

The current trial examined the value of modifying empirically validated treatment for childhood anxiety for application via written materials for parents of anxious children. Two hundred sixty-seven clinically anxious children ages 6-12 years and their parents were randomly allocated to standard group treatment, wait list, or a bibliotherapy…

A Critical Analysis of the CELF-4: The Responsible Clinician's Guide to the CELF-4

ERIC Educational Resources Information Center

Crowley, Catherine Jane

2010-01-01

Purpose: To provide an analysis of the accuracy and effectiveness of using the Clinical Evaluation of Language Fundamentals-Fourth Edition (CELF-4) to identify students as having language-based disabilities. Method: The CELF-4 is analyzed within the current standards set by the federal law on special education, the available research, preferred…

Validating the Factor Structure of the Self-Report Psychopathy Scale in a Community Sample

ERIC Educational Resources Information Center

Mahmut, Mehmet K.; Menictas, Con; Stevenson, Richard J.; Homewood, Judi

2011-01-01

Currently, there is no standard self-report measure of psychopathy in community-dwelling samples that parallels the most commonly used measure of psychopathy in forensic and clinical samples, the Psychopathy Checklist. A promising instrument is the Self-Report Psychopathy scale (SRP), which was derived from the original version the Psychopathy…

Medicare Long-Term CPAP Coverage Policy: A Cost-Utility Analysis

PubMed Central

Billings, Martha E.; Kapur, Vishesh K.

2013-01-01

Study Objectives: CPAP is an effective treatment for OSA that may reduce health care utilization and costs. Medicare currently reimburses the costs of long-term CPAP therapy only if the patient is adherent during a 90-day trial. If not, Medicare requires a repeat polysomnogram (PSG) and another trial which seems empirically not cost-effective. We modeled the cost-effectiveness of current Medicare policy compared to an alternative policy (clinic-only) without the adherence criterion and repeat PSG. Design: Cost-utility and cost-effectiveness analysis. Setting: U.S. Medicare Population. Patients or Participants: N/A. Interventions: N/A. Measurements and Results: We created a decision tree modeling (1) clinic only follow-up vs. (2) current Medicare policy. Costs were assigned based on Medicare reimbursement rates in 2012. Sensitivity analyses were conducted to test our assumptions. We estimated cumulative costs, overall adherence, and QALY gained for a 5-year time horizon from the perspective of Medicare as the payer. Current Medicare policy is more costly than the clinic-only policy but has higher net adherence and improved utility. Current Medicare policy compared to clinic-only policy costs $30,544 more per QALY. Conclusions: Current CMS policy promotes early identification of those more likely to adhere to CPAP therapy by requiring strict adherence standards. The policy effect is to deny coverage to those unlikely to use CPAP long-term and prevent wasted resources. Future studies are needed to measure long-term adherence in an elderly population with and without current adherence requirements to verify the cost-effectiveness of a policy change. Citation: Billings ME; Kapur VK. Medicare long-term CPAP coverage policy: a cost-utility analysis. J Clin Sleep Med 2013;9(10):1023-1029. PMID:24127146

Minimal Residual Disease in Acute Myeloid Leukemia

PubMed Central

Hourigan, Christopher S.; Karp, Judith E.

2014-01-01

Technological advances in the laboratory have lead to substantial improvements in clinical decision-making by the use of pre-treatment prognostic risk stratification factors in acute myeloid leukemia (AML). Unfortunately similar progress has not been made in treatment response criteria, with the definition of “complete remission” in AML largely unchanged for over half a century. Several recent clinical trials have demonstrated that higher sensitivity measurements of residual disease burden during or after treatment can be performed, that results are predictive for clinical outcome and can be used to improve outcomes by guiding additional therapeutic intervention to patients in clinical complete remission but at increased relapse risk. We review here these recent trials, the characteristics and challenges of the modalities currently used to detect minimal residual disease (MRD), and outline opportunities to both refine detection and better clinically utilize MRD measurements. MRD measurement is already the standard of care in other myeloid malignancies such as chronic myelogenous leukemia (CML) and acute promyelocytic leukemia (APL). It is our belief that response criteria for non-APL AML should be updated to include assessment for molecular complete remission (mCR) and that recommendations for post-consolidation surveillance should include regular monitoring for molecular relapse as a standard of care. PMID:23799371

Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration

PubMed Central

Bossuyt, V.; Provenzano, E.; Symmans, W. F.; Boughey, J. C.; Coles, C.; Curigliano, G.; Dixon, J. M.; Esserman, L. J.; Fastner, G.; Kuehn, T.; Peintinger, F.; von Minckwitz, G.; White, J.; Yang, W.; Badve, S.; Denkert, C.; MacGrogan, G.; Penault-Llorca, F.; Viale, G.; Cameron, D.; Earl, Helena; Alba, Emilio; Lluch, Ana; Albanell, Joan; Amos, Keith; Biernat, Wojciech; Bonnefoi, Hervé; Buzdar, Aman; Cane, Paul; Pinder, Sarah; Carson, Lesley; Dickson-Witmer, Diana; Gong, Gyungyub; Green, Jimmy; Hsu, Chih-Yi; Tseng, Ling-Ming; Kroep, Judith; Leitch, A. Marilyn; Sarode, Venetia; Mamounas, Eleftherios; Marcom, Paul Kelly; Nuciforo, Paolo; Paik, Soonmyung; Peg, Vicente; Peston, David; Pierga, Jean-Yves; Quintela-Fandino, Miguel; Salgado, Roberto; Sikov, William; Thomas, Jeremy; Unzeitig, Gary; Wesseling, Jelle

2015-01-01

Neoadjuvant systemic therapy (NAST) provides the unique opportunity to assess response to treatment after months rather than years of follow-up. However, significant variability exists in methods of pathologic assessment of response to NAST, and thus its interpretation for subsequent clinical decisions. Our international multidisciplinary working group was convened by the Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration and tasked to recommend practical methods for standardized evaluation of the post-NAST surgical breast cancer specimen for clinical trials that promote accurate and reliable designation of pathologic complete response (pCR) and meaningful characterization of residual disease. Recommendations include multidisciplinary communication; clinical marking of the tumor site (clips); and radiologic, photographic, or pictorial imaging of the sliced specimen, to map the tissue sections and reconcile macroscopic and microscopic findings. The information required to define pCR (ypT0/is ypN0 or ypT0 yp N0), residual ypT and ypN stage using the current AJCC/UICC system, and the Residual Cancer Burden system were recommended for quantification of residual disease in clinical trials. PMID:26019189

Longitudinal construct validity: establishment of clinical meaning in patient evaluative instruments.

PubMed

Liang, M H

2000-09-01

Although widely used and reported in research for the evaluation of groups, measures of health status and health-related quality of life have had little application in clinical practice for the assessment of individual patients. One of the principal barriers is the demonstration that these measures add clinically significant information to measures of function or symptoms alone. Here, we review the methods for evaluation of construct validity in longitudinal studies and make recommendations for nomenclature, reporting of study results, and future research agenda. Analytical review. The terms "sensitivity" and "responsiveness" have been used interchangeably, and there are few studies that evaluate the extent to which health status or health-related quality-of life measures capture clinically important changes ("responsiveness"). Current methods of evaluating responsiveness are not standardized or evaluated. Approaches for the assessment of a clinically significant or meaningful change are described; rather than normative information, however, standardized transition questions are proposed. They would be reported routinely and as separate axes of description to capture individual perceptions. Research in methods to assess the subject's evaluation of the importance and magnitude of a measured change are critical if health status and health-related quality-of-life measures are to have an impact on patient care.

Estimating premorbid general cognitive functioning for children and adolescents using the American Wechsler Intelligence Scale for Children-Fourth Edition: demographic and current performance approaches.

PubMed

Schoenberg, Mike R; Lange, Rael T; Brickell, Tracey A; Saklofske, Donald H

2007-04-01

Neuropsychologic evaluation requires current test performance be contrasted against a comparison standard to determine if change has occurred. An estimate of premorbid intelligence quotient (IQ) is often used as a comparison standard. The Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV) is a commonly used intelligence test. However, there is no method to estimate premorbid IQ for the WISC-IV, limiting the test's utility for neuropsychologic assessment. This study develops algorithms to estimate premorbid Full Scale IQ scores. Participants were the American WISC-IV standardization sample (N = 2172). The sample was randomly divided into 2 groups (development and validation). The development group was used to generate 12 algorithms. These algorithms were accurate predictors of WISC-IV Full Scale IQ scores in healthy children and adolescents. These algorithms hold promise as a method to predict premorbid IQ for patients with known or suspected neurologic dysfunction; however, clinical validation is required.

Diagnostic and Prognostic Utility of Fluorescence In situ Hybridization (FISH) Analysis in Acute Myeloid Leukemia.

PubMed

Gonzales, Patrick R; Mikhail, Fady M

2017-12-01

Acute myeloid leukemia (AML) is a hematologic neoplasia consisting of incompletely differentiated hematopoietic cells of the myeloid lineage that proliferate in the bone marrow, blood, and/or other tissues. Clinical implementation of fluorescence in situ hybridization (FISH) in cytogenetic laboratories allows for high-resolution analysis of recurrent structural chromosomal rearrangements specific to AML, especially in AML with normal karyotypes, which comprises approximately 33-50% of AML-positive specimens. Here, we review the use of several FISH probe strategies in the diagnosis of AML. We also review the standards and guidelines currently in place for use by clinical cytogenetic laboratories in the evaluation of AML. Updated standards and guidelines from the WHO, ACMG, and NCCN have further defined clinically significant, recurring cytogenetic anomalies in AML that are detectable by FISH. FISH continues to be a powerful technique in the diagnosis of AML, with higher resolution than conventional cytogenetic analysis, rapid turnaround time, and a considerable diagnostic and prognostic utility.

How galectin-3 changes acute heart failure decision making in the emergency department.

PubMed

Peacock, W Frank

2014-10-01

When considering the appropriate disposition plan in a patient presenting to the emergency department (ED) with acute heart failure (HF), the range of options includes discharge home to intensive care unit (ICU) admission. Unfortunately, there are few objective measures to insure optimal choices, and the currently available science is scant at best. The consequences of a lack of a standardized approach are nowhere more evident than as demonstrated by the worldwide 90-day heart failure rehospitalization rate that exceeds 25%. New strategies to address this important gap in clinical care are sorely needed. The measurement of galectin-3 may represent a new alternative to the historical standard of gestalt-based clinical disposition decisions. Elevated galectin-3 can identify patients at very high risk for short-term adverse outcomes, while low levels identify a population with essentially no 90-day revisits. This prospective objective measure of illness severity may aid in clinical decision making and thus represent a future where rehospitalization after HF is an unusual event.

Antibiotics for the treatment of dysentery in children.

PubMed

Traa, Beatrix S; Walker, Christa L Fischer; Munos, Melinda; Black, Robert E

2010-04-01

Ciprofloxacin, ceftriaxone and pivmecillinam are the antibiotics currently recommended by the World Health Organization (WHO) for the treatment of dysentery in children; yet there have been no reviews of the clinical effectiveness of these antibiotics in recent years. We reviewed all literature reporting the effect of ciprofloxacin, ceftriaxone and pivmecillinam for the treatment of dysentery in children in the developing countries. We used a standardized abstraction and grading format and performed meta-analyses to determine the effect of treatment with these antibiotics on rates of treatment failure, bacteriological failure and bacteriological relapse. The CHERG Standard Rules were applied to determine the final effect of treatment with these antibiotics on diarrhoea mortality. Eight papers were selected for abstraction. Treatment with ciprofloxacin, ceftriaxone or pivmecillinam resulted in a cure rate of >99% while assessing clinical failure, bacteriological failure and bacteriological relapse. The antibiotics recommended by the WHO--ciprofloxacin, ceftriaxone and pivmecillinam--are effective in reducing the clinical and bacteriological signs and symptoms of dysentery and thus can be expected to decrease diarrhoea mortality attributable to dysentery.

Robotic Colorectal Surgery

PubMed Central

2008-01-01

Robotic colorectal surgery has gradually been performed more with the help of the technological advantages of the da Vinci® system. Advanced technological advantages of the da Vinci® system compared with standard laparoscopic colorectal surgery have been reported. These are a stable camera platform, three-dimensional imaging, excellent ergonomics, tremor elimination, ambidextrous capability, motion scaling, and instruments with multiple degrees of freedom. However, despite these technological advantages, most studies did not report the clinical advantages of robotic colorectal surgery compared to standard laparoscopic colorectal surgery. Only one study recently implies the real benefits of robotic rectal cancer surgery. The purpose of this review article is to outline the early concerns of robotic colorectal surgery using the da Vinci® system, to present early clinical outcomes from the most current series, and to discuss not only the safety and the feasibility but also the real benefits of robotic colorectal surgery. Moreover, this article will comment on the possible future clinical advantages and limitations of the da Vinci® system in robotic colorectal surgery. PMID:19108010

Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial.

PubMed

Brittain, Clare; Childs, Margaret; Duley, Lelia; Harding, Jan; Hepburn, Trish; Meakin, Garry; Montgomery, Alan A; Tan, Wei; Ross, Jonathan D C

2016-11-24

Gonorrhoea is a common sexually transmitted infection which causes genital pain and discomfort; in women it can also lead to pelvic inflammatory disease and infertility, and in men to epididymo-orchitis. Current treatment is with ceftriaxone, but there is increasing evidence of antimicrobial resistance which is reducing its effectiveness against gonorrhoea. A small, but increasing, number of patients have already been found to have highly resistant strains of gonorrhoea which has been associated with clinical failure. This trial aims to determine whether gentamicin is not clinically worse than ceftriaxone in the treatment of gonorrhoea. This is a blinded, two-arm, multicentre, noninferiority randomised trial. Patients are eligible if they are aged 16-70 years with a diagnosis of genital, pharyngeal and/or rectal gonorrhoea. Exclusion criteria are: known concurrent sexually transmitted infection(s) (excluding chlamydia); bacterial vaginosis and/or Trichomonas vaginalis infection; contraindications or an allergy to gentamicin, ceftriaxone, azithromycin or lidocaine; pregnancy or breastfeeding; complicated gonorrhoeal infection; weight under 40 kg; use of ceftriaxone, gentamicin or azithromycin within the preceding 28 days. Randomisation is to receive a single intramuscular injection of either gentamicin or ceftriaxone, all participants receive 1 g oral azithromycin as standard treatment. The estimated sample size is 720 participants (noninferiority limit 5%). The primary outcome is clearance of Neisseria gonorrhoeae at all infected sites by a negative Nucleic Acid Amplification Test, 2 weeks post treatment. Secondary outcomes include clinical resolution of symptoms, frequency of adverse events, tolerability of therapy, relationship between clinical effectiveness and antibiotic minimum inhibitory concentration for N. gonorrhoeae, and cost-effectiveness. The options for future treatment of gonorrhoea are limited. Results from this randomised trial will demonstrate whether gentamicin is not clinically worse than ceftriaxone for the treatment of gonorrhoea. This will inform clinical practice and policy for the treatment of gonorrhoea when current therapy with cephalosporins is no longer effective, or is contraindicated. International Standard Randomised Controlled Trial Number - ISRCTN51783227 , Registered on 18 September 2014. Current protocol version 2.0 17 June 2015.

Agreement between clinical and MINI diagnoses in outpatients with mood and anxiety disorders.

PubMed

Verhoeven, F E A; Swaab, L S M A; Carlier, I V E; van Hemert, A M; Zitman, F G; Ruhé, H G; Schoevers, R A; Giltay, E J

2017-10-15

Standardized Diagnostic Interviews (SDIs) such as the Mini International Neuropsychiatric Interview (MINI) are widely used to systematically screen for psychiatric disorders in research. To support generalizability of results to clinical practice, we assessed agreement between the MINI and clinical diagnoses. Agreement was assessed in a large, real life dataset (n = 7016) using concordance statistics such as sensitivity, specificity, efficiency and area under the curve (AUC). 41.5% of clinical diagnoses were mood disorders, 26.5% were anxiety disorders. Overall, we found moderate agreement between MINI and clinical diagnoses (median efficiency: 0.92, median AUC: 0.79). For mood disorders, the AUC for all participants showed a range between 0.55 and 0.81 (median: 0.73), and for anxiety disorders the AUC ranged from 0.78 to 0.88 (median: 0.83). The AUC showed better agreement for mood disorders in the single diagnosis group than in the total group (median 0.77 vs. 0.71). For anxiety disorders, the AUC for the single diagnosis group was comparable to the AUC of the total group (median: 0.81 vs. 0.83 respectively). Numbers of false positives were high for both mood and anxiety diagnoses, but less so in the single diagnosis group. Time lag between MINI and clinical diagnosis, the availability of only the primary clinical diagnosis, and relatively high severity of the current sample are limitations of the current study. Agreement between MINI and clinical diagnoses was moderate at best, which partly reflects the difference between the different measures used in the current study. Copyright © 2017 Elsevier B.V. All rights reserved.

How to perform a critical appraisal of diagnostic tests: 7 steps.

PubMed

Chughtai, Aamer; Kelly, Aine Marie; Cronin, Paul

2015-06-01

The critically appraised topic (CAT) is a format in evidence-based practice for sharing information. A CAT is a standardized way of summarizing the most current research evidence focused on a pertinent clinical question. Its aim is to provide both a critique of the most up-to-date retrieved research and an indication of the clinical relevance of results. A clinical question is initially generated following a patient encounter, which leads to and directs a literature search to answer the clinical question. Studies obtained from the literature search are assigned a level of evidence. This allows the most valid and relevant articles to be selected and to be critically appraised. The results are summarized, and this information is translated into clinically useful procedures and processes.

Hospital Guidelines for Diabetes Management and the Joint Commission-American Diabetes Association Inpatient Diabetes Certification.

PubMed

Arnold, Pamela; Scheurer, Danielle; Dake, Andrew W; Hedgpeth, Angela; Hutto, Amy; Colquitt, Caroline; Hermayer, Kathie L

2016-04-01

The Joint Commission Advanced Inpatient Diabetes Certification Program is founded on the American Diabetes Association's Clinical Practice Recommendations and is linked to the Joint Commission Standards. Diabetes currently affects 29.1 million people in the USA and another 86 million Americans are estimated to have pre-diabetes. On a daily basis at the Medical University of South Carolina (MUSC) Medical Center, there are approximately 130-150 inpatients with a diagnosis of diabetes. The program encompasses all service lines at MUSC. Some important features of the program include: a program champion or champion team, written blood glucose monitoring protocols, staff education in diabetes management, medical record identification of diabetes, a plan coordinating insulin and meal delivery, plans for treatment of hypoglycemia and hyperglycemia, data collection for incidence of hypoglycemia, and patient education on self-management of diabetes. The major clinical components to develop, implement, and evaluate an inpatient diabetes care program are: I. Program management, II. Delivering or facilitating clinical care, III. Supporting self-management, IV. Clinical information management and V. performance measurement. The standards receive guidance from a Disease-Specific Care Certification Advisory Committee, and the Standards and Survey Procedures Committee of the Joint Commission Board of Commissioners. The Joint Commission-ADA Advanced Inpatient Diabetes Certification represents a clinical program of excellence, improved processes of care, means to enhance contract negotiations with providers, ability to create an environment of teamwork, and heightened communication within the organization. Published by Elsevier Inc.

In Vivo Evaluation of ¹⁸F-SiFAlin-Modified TATE: A Potential Challenge for ⁶⁸Ga-DOTATATE, the Clinical Gold Standard for Somatostatin Receptor Imaging with PET.

PubMed

Niedermoser, Sabrina; Chin, Joshua; Wängler, Carmen; Kostikov, Alexey; Bernard-Gauthier, Vadim; Vogler, Nils; Soucy, Jean-Paul; McEwan, Alexander J; Schirrmacher, Ralf; Wängler, Björn

2015-07-01

Radiolabeled peptides for tumor imaging with PET that can be produced with kits are currently in the spotlight of radiopharmacy and nuclear medicine. The diagnosis of neuroendocrine tumors in particular has been a prime example for the usefulness of peptides labeled with a variety of different radionuclides. Among those, (68)Ga and (18)F stand out because of the ease of radionuclide introduction (e.g., (68)Ga isotope) or optimal nuclide properties for PET imaging (slightly favoring the (18)F isotope). The in vivo properties of good manufacturing practice-compliant, newly developed kitlike-producible (18)F-SiFA- and (18)F-SiFAlin- (SiFA = silicon-fluoride acceptor) modified TATE derivatives were compared with the current clinical gold standard (68)Ga-DOTATATE for high-quality imaging of somatostatin receptor-bearing tumors. SiFA- and SiFAlin-derivatized somatostatin analogs were synthesized and radiolabeled using cartridge-based dried (18)F and purified via a C18 cartridge (radiochemical yield 49.8% ± 5.9% within 20-25 min) without high-performance liquid chromatography purification. Tracer lipophilicity and stability in human serum were tested in vitro. Competitive receptor binding affinity studies were performed using AR42J cells. The most promising tracers were evaluated in vivo in an AR42J xenograft mouse model by ex vivo biodistribution and in vivo PET/CT imaging studies for evaluation of their pharmacokinetic profiles, and the results were compared with those of the current clinical gold standard (68)Ga-DOTATATE. Synthetically easily accessible (18)F-labeled silicon-fluoride acceptor-modified somatostatin analogs were developed. They exhibited high binding affinities to somatostatin receptor-positive tumor cells (1.88-14.82 nM). The most potent compound demonstrated comparable pharmacokinetics and an even slightly higher absolute tumor accumulation level in ex vivo biodistribution studies as well as higher tumor standardized uptake values in PET/CT imaging than (68)Ga-DOTATATE in vivo. The radioactivity uptake in nontumor tissue was higher than for (68)Ga-DOTATATE. The introduction of the novel SiFA building block SiFAlin and of hydrophilic auxiliaries enables a favorable in vivo biodistribution profile of the modified TATE peptides, resulting in high tumor-to-background ratios although lower than those observed with (68)Ga-DOTATATE. As further advantage, the SiFA methodology enables a kitlike labeling procedure for (18)F-labeled peptides advantageous for routine clinical application. © 2015 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Functional heartburn: the stimulus, the pain, and the brain

PubMed Central

Fass, R; Tougas, G

2002-01-01

Functional heartburn is a common disorder and appears to be composed of several distinct subgroups. Identifying the different subgroups based on clinical history only is not achievable at present. The mechanisms responsible for pain, clinical characteristics, and the optimal therapeutic approach remain poorly understood. Response to potent antireflux treatment is relatively limited. Current and future treatment strategies for functional heartburn patients who have failed standard dose proton pump inhibitors (PPIs) include increased PPI dose in some, as well as addition of pain modulators in others. PMID:12427796

The Johns Hopkins RTR Consortium: A Collaborative Approach to Advance Translational Science and Standardize Clinical Monitoring of Restorative Transplantation

DTIC Science & Technology

2016-10-01

non-myeloablative conditioning plus bone marrow infusion (BMI) and intermediate dose tacrolimus (10-15 ng/ml) for 30 days only. Group VIII received the...induction regimen, BMI and CTLA4-Ig and a short-term dose of tacrolimus (30 days ). In all groups, graft rejection was monitored by clinical...long-term graft survival (>230 days ). In the current reporting period (Aim 2 and Aim 3), 3/3 animals in group IV and 4/5 animals in Group V achieved

Misclassification of acute respiratory distress syndrome after traumatic injury: The cost of less rigorous approaches.

PubMed

Hendrickson, Carolyn M; Dobbins, Sarah; Redick, Brittney J; Greenberg, Molly D; Calfee, Carolyn S; Cohen, Mitchell Jay

2015-09-01

Adherence to rigorous research protocols for identifying adult respiratory distress syndrome (ARDS) after trauma is variable. To examine how misclassification of ARDS may bias observational studies in trauma populations, we evaluated the agreement of two methods for adjudicating ARDS after trauma: the current gold standard, direct review of chest radiographs and review of dictated radiology reports, a commonly used alternative. This nested cohort study included 123 mechanically ventilated patients between 2005 and 2008, with at least one PaO2/FIO2 less than 300 within the first 8 days of admission. Two blinded physician investigators adjudicated ARDS by two methods. The investigators directly reviewed all chest radiographs to evaluate for bilateral infiltrates. Several months later, blinded to their previous assessments, they adjudicated ARDS using a standardized rubric to classify radiology reports. A κ statistics was calculated. Regression analyses quantified the association between established risk factors as well as important clinical outcomes and ARDS determined by the aforementioned methods as well as hypoxemia as a surrogate marker. The κ was 0.47 for the observed agreement between ARDS adjudicated by direct review of chest radiographs and ARDS adjudicated by review of radiology reports. Both the magnitude and direction of bias on the estimates of association between ARDS and established risk factors as well as clinical outcomes varied by method of adjudication. Classification of ARDS by review of dictated radiology reports had only moderate agreement with the current gold standard, ARDS adjudicated by direct review of chest radiographs. While the misclassification of ARDS had varied effects on the estimates of associations with established risk factors, it tended to weaken the association of ARDS with important clinical outcomes. A standardized approach to ARDS adjudication after trauma by direct review of chest radiographs will minimize misclassification bias in future observational studies. Diagnostic study, level II.

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

PubMed

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.

Benefits of Outsourcing Strategy and IT Technology in Clinical Trials.

PubMed

Stamenovic, Milorad; Dobraca, Amra

2017-09-01

Aim of this paper is to describe some of models of outsourcing (numerous and response to different types of risks and increment of quality is based on individual problem and situation). Defining whether to outsource or not and whether to build or buy new information technology (IT) is question for contract research organization (CRO) and Pharma companies dealing with clinical trials, so the aim of this paper is to show business model that could make process of decision making less time consuming, less segmented and more efficient. This paper has a descriptive character, and represents a review of the literature that deals with the described issues. Outsourcing should enable optimal capacity flexibility (technology that is outsourced should be done only optimally not entirely). The goal with CRO partners is to establish equivalent levels of global quality, as extensions of other research and development activities (by unification of standards of performance of alliance partners with best standards of industry). IT is gaining greater significance at each stage of clinical study and represent an inevitable element of the quality of a clinical study (for the purpose of monitoring of clinical site activities, data collection and management, medical monitoring, statistical programming, statistical analysis, clinical study reporting). CROs are able to maximize work within the CRO global development, to support the notion of a fully integrated outsourced company; facilitate the use of similar business processes and norms, reusing established CRO standards and improve CRO operational decision making within outsourced studies by providing consistent and current information across outsourced and in-house activities.

Benefits of Outsourcing Strategy and IT Technology in Clinical Trials

PubMed Central

Stamenovic, Milorad; Dobraca, Amra

2017-01-01

Introduction: Aim of this paper is to describe some of models of outsourcing (numerous and response to different types of risks and increment of quality is based on individual problem and situation). Defining whether to outsource or not and whether to build or buy new information technology (IT) is question for contract research organization (CRO) and Pharma companies dealing with clinical trials, so the aim of this paper is to show business model that could make process of decision making less time consuming, less segmented and more efficient. Material and methods: This paper has a descriptive character, and represents a review of the literature that deals with the described issues. Results: Outsourcing should enable optimal capacity flexibility (technology that is outsourced should be done only optimally not entirely). The goal with CRO partners is to establish equivalent levels of global quality, as extensions of other research and development activities (by unification of standards of performance of alliance partners with best standards of industry). IT is gaining greater significance at each stage of clinical study and represent an inevitable element of the quality of a clinical study (for the purpose of monitoring of clinical site activities, data collection and management, medical monitoring, statistical programming, statistical analysis, clinical study reporting). Conclusion: CROs are able to maximize work within the CRO global development, to support the notion of a fully integrated outsourced company; facilitate the use of similar business processes and norms, reusing established CRO standards and improve CRO operational decision making within outsourced studies by providing consistent and current information across outsourced and in-house activities. PMID:29114116

Sequence variant classification and reporting: recommendations for improving the interpretation of cancer susceptibility genetic test results

PubMed Central

Plon, Sharon E.; Eccles, Diana M.; Easton, Douglas; Foulkes, William D.; Genuardi, Maurizio; Greenblatt, Marc S.; Hogervorst, Frans B.L.; Hoogerbrugge, Nicoline; Spurdle, Amanda B.; Tavtigian, Sean

2011-01-01

Genetic testing of cancer susceptibility genes is now widely applied in clinical practice to predict risk of developing cancer. In general, sequence-based testing of germline DNA is used to determine whether an individual carries a change that is clearly likely to disrupt normal gene function. Genetic testing may detect changes that are clearly pathogenic, clearly neutral or variants of unclear clinical significance. Such variants present a considerable challenge to the diagnostic laboratory and the receiving clinician in terms of interpretation and clear presentation of the implications of the result to the patient. There does not appear to be a consistent approach to interpreting and reporting the clinical significance of variants either among genes or among laboratories. The potential for confusion among clinicians and patients is considerable and misinterpretation may lead to inappropriate clinical consequences. In this article we review the current state of sequence-based genetic testing, describe other standardized reporting systems used in oncology and propose a standardized classification system for application to sequence based results for cancer predisposition genes. We suggest a system of five classes of variants based on the degree of likelihood of pathogenicity. Each class is associated with specific recommendations for clinical management of at-risk relatives that will depend on the syndrome. We propose that panels of experts on each cancer predisposition syndrome facilitate the classification scheme and designate appropriate surveillance and cancer management guidelines. The international adoption of a standardized reporting system should improve the clinical utility of sequence-based genetic tests to predict cancer risk. PMID:18951446

The Evolution of Prognostic Factors in Multiple Myeloma

PubMed Central

Hassanein, Mona; Rasheed, Walid; Aljurf, Mahmoud; Alsharif, Fahad

2017-01-01

Multiple myeloma (MM) is a heterogeneous hematologic malignancy involving the proliferation of plasma cells derived by different genetic events contributing to the development, progression, and prognosis of this disease. Despite improvement in treatment strategies of MM over the last decade, the disease remains incurable. All efforts are currently focused on understanding the prognostic markers of the disease hoping to incorporate the new therapeutic modalities to convert the disease into curable one. We present this comprehensive review to summarize the current standard prognostic markers used in MM along with novel techniques that are still in development and highlight their implications in current clinical practice. PMID:28321258

RECONCEPTUALIZING CONSENT FOR DIRECT-TO-CONSUMER HEALTH SERVICES.

PubMed

Spector-Bagdady, Kayte

2015-01-01

The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports "that meet [Food and Drug Administration] standards for being clinically and scientifically valid." Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of "informed consent" began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy--but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach? This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing. DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as "intended for entertainment purposes only," it can provide medical information as an incidental finding. 23andMe currently purports to be the only DTC genetics service that "includes" reports that meet FDA qualifications, despite disclaimers of intent to "provide medical advice." The attempted de-medicalization of these devices, therefore, has not been fully transformative, and DTC providers should have more robust ethical and legal duties than the average goods and services seller. This Article delineates these responsibilities, beginning with ethical duties surrounding marketing, entering into, and providing DTC services. It then turns to the legal paradigms necessary to enable, or at least allow for, DTC providers to meet these ethical obligations. While it argues that contractual, as opposed to fiduciary, requirements are most appropriate and that waivers of liability will likely be upheld, it also advocates for a heightened expectation of disclosure during contracting.

MALDI-TOF MS in the Microbiology Laboratory: Current Trends.

PubMed

Schubert, Sören; Kostrzewa, Markus

2017-01-01

Within less than a decade matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) has become a gold standard for microbial identification in clinical microbiology laboratories. Besides identification of microorganisms the typing of single strains as well as the antibiotic and antimycotic resistance testing has come into focus in order to speed up the microbiological diagnostic. However, the full potential of MALDI-TOF MS has not been tapped yet and future technological advancements will certainly expedite this method towards novel applications and enhancement of current practice. So, the following chapter shall be rather a brainstorming and forecast of how MALDI-TOF MS will develop to influence clinical diagnostics and microbial research in the future. It shall open up the stage for further discussions and does not claim for overall validity.

Effect of ion implantation on the tribology of metal-on-metal hip prostheses.

PubMed

Bowsher, John G; Hussain, Azad; Williams, Paul; Nevelos, Jim; Shelton, Julia C

2004-12-01

Nitrogen ion implantation (which considerably hardens the surface of the bearing) may represent one possible method of reducing the wear of metal-on-metal (MOM) hip bearings. Currently there are no ion-implanted MOM bearings used clinically. Therefore a physiological hip simulator test was undertaken using standard test conditions, and the results compared to previous studies using the same methods. N2-ion implantation of high carbon cast Co-Cr-Mo-on-Co-Cr-Mo hip prostheses increased wear by 2-fold during the aggressive running-in phase compared to untreated bearing surfaces, plus showing no wear reductions during steady-state conditions. Although 2 specimens were considered in the current study, it would appear that ion implantation has no clinical benefit for MOM.

Oncolytic Poxviruses

PubMed Central

Chan, Winnie M.; McFadden, Grant

2015-01-01

Current standard treatments of cancer can prolong survival of many cancer patients but usually do not effectively cure the disease. Oncolytic virotherapy is an emerging therapeutic for the treatment of cancer that exploits replication-competent viruses to selectively infect and destroy cancerous cells while sparing normal cells and tissues. Clinical and/or preclinical studies on oncolytic viruses have revealed that the candidate viruses being tested in trials are remarkably safe and offer potential for treating many classes of currently incurable cancers. Among these candidates are vaccinia and myxoma viruses, which belong to the family Poxviridae and possess promising oncolytic features. This article describes poxviruses that are being developed for oncolytic virotherapy and summarizes the outcomes of both clinical and preclinical studies. Additionally, studies demonstrating superior efficacy when poxvirus oncolytic virotherapy is combined with conventional therapies are described. PMID:25839047

China Biobanking.

PubMed

Zhang, Yong; Li, Qiyuan; Wang, Xian; Zhou, Xiaolin

2015-01-01

Biobanks are playing increasingly important roles in clinical and translational research nowadays. China, as a country with the largest population and abundant clinical resources, attaches great importance to the development of biobanks. In recent years, with the increasing support from the Chinese government, biobanks are blooming across the country. This paper provides a detailed overview of China biobanking, which is further divided in the following four parts: (i) general introduction of the number, category and distribution of current biobanks; (ii) summarization of the current development status, and issues that Chinese biobanks are faced with; (iii) international cooperation between China and the global biobanking community; (iv) prospect of the modern twenty-first century Chinese biobanks, which would achieve standardized operation, systematic specimen management, and extensive collaboration, and thus provide support for the robust research discoveries and personalized medicine etc.

Irritable bowel syndrome: A clinical review

PubMed Central

Soares, Rosa LS

2014-01-01

Irritable bowel syndrome (IBS) remains a clinical challenge in the 21st century. It’s the most commonly diagnosed gastrointestinal condition and also the most common reason for referral to gastroenterology clinics. Its can affect up to one in five people at some point in their lives, and has a significantly impact of life quality and health care utilization. The prevalence varies according to country and criteria used to define IBS. Various mechanisms and theories have been proposed about its etiology, but the biopsychosocial model is the most currently accepted for IBS. The complex of symptoms would be the result of the interaction between psychological, behavioral, psychosocial and environmental factors. The diagnosis of IBS is not confirmed by a specific test or structural abnormality. It is made using criteria based on clinical symptoms such as Rome criteria, unless the symptoms are thought to be atypical. Today the Rome Criteria III is the current gold-standard for the diagnoses of IBS. Secure positive evidence of IBS by means of specific disease marker is currently not possible and cannot be currently recommended for routine diagnosis. There is still no clinical evidence to recommend the use of biomarkers in blood to diagnose IBS. However, a number of different changes in IBS patients were demonstrated in recent years, some of which can be used in the future as a diagnostic support. IBS has no definitive treatment but could be controlled by non-pharmacologic management eliminating of some exacerbating factors such certain drugs, stressor conditions and changes in dietary habits.The traditional pharmacologic management of IBS has been symptom based and several drugs have been used. However, the cornerstone of its therapy is a solid patient physician relationship. This review will provide a summary of pathophysiology, diagnostic criteria and current and emerging therapies for IBS. PMID:25232249

Novel end points for clinical trials in young children with cystic fibrosis.

PubMed

Simpson, Shannon J; Mott, Lauren S; Esther, Charles R; Stick, Stephen M; Hall, Graham L

2013-06-01

Cystic fibrosis (CF) lung disease commences early in the disease progression and is the most common cause of mortality. While new CF disease-modifying agents are currently undergoing clinical trial evaluation, the implementation of such trials in young children is limited by the lack of age-appropriate clinical trial end points. Advances in infant and preschool lung function testing, imaging of the chest and the development of biochemical biomarkers have led to increased possibility of quantifying mild lung disease in young children with CF and objectively monitoring disease progression over the course of an intervention. Despite this, further standardization and development of these techniques is required to provide robust objective measures for clinical trials in this age group.

The challenge of Propionibacterium acnes and revision shoulder arthroplasty: a review of current diagnostic options.

PubMed

Shields, Margaret V; Abdullah, Leath; Namdari, Surena

2016-06-01

Propionibacterium acnes is the most common cause of infection after shoulder arthroplasty. Whereas there are several methods that can aid in the diagnosis of P. acnes infection, there is not a single "gold standard" because of the difficulties inherent in identifying this bacterium. We present an evidence-based discussion of the demographic, clinical, and radiographic predictors of P. acnes infection and review the current options for diagnosis. This review was written after a comprehensive analysis of the current literature related to shoulder periprosthetic joint infection and P. acnes identification. Of the techniques reviewed, α-defensin had the highest sensitivity in detecting P. acnes infection (63%). C-reactive protein level and erythrocyte sedimentation rate were often normal in cases of infection. Whereas P. acnes can be challenging to successfully diagnose, there are several options that are considered preferable because of their higher sensitivities and specificities. The current gold standard is intraoperative culture, but major advances in molecular techniques may provide future improvements in diagnostic accuracy. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Male bladder outlet obstruction: Time to re-evaluate the definition and reconsider our diagnostic pathway? ICI-RS 2015.

PubMed

Rademakers, Kevin; Drake, Marcus J; Gammie, Andrew; Djurhuus, Jens C; Rosier, Peter F W M; Abrams, Paul; Harding, Christopher

2017-04-01

The diagnosis of bladder outlet obstruction (BOO) in the male is dependent on measurements of pressure and flow made during urodynamic studies. The procedure of urodynamics and the indices used to delineate BOO are well standardized largely as a result of the work of the International Continence Society. The clinical utility of the diagnosis of BOO is however, less well defined and there are several shortcomings and gaps in the currently available medical literature. Consequently the International Consultation on Incontinence Research Society (ICI-RS) held a think tank session in 2015 entitled "Male bladder outlet obstruction: Time to re-evaluate the definition and reconsider our diagnostic pathway?" This manuscript details the discussions that took place within that think tank setting out the pros and cons of the current definition of BOO and exploring alternative clinical tests (alone or in combination) which may be useful in the future investigation of male patients with lower urinary tract symptoms. The think tank panel concluded that pressure-flow studies remain the diagnostic gold-standard for BOO although there is still a lack of high quality evidence. Newer, less invasive, investigations have shown promise in terms of diagnostic accuracy for BOO but similar criticisms can be levelled against these tests. Therefore, the think tank suggests further research with regard to these alternative indicators to determine their clinical utility. © 2017 Wiley Periodicals, Inc.

The effect of cone beam CT (CBCT) on therapeutic decision-making in endodontics.

PubMed

Mota de Almeida, F J; Knutsson, K; Flygare, L

2014-01-01

The aim was to assess to what extent cone beam CT (CBCT) used in accordance with current European Commission guidelines in a normal clinical setting has an impact on therapeutic decisions in a population referred for endodontic problems. The study includes data of consecutively examined patients collected from October 2011 to December 2012. From 2 different endodontic specialist clinics, 57 patients were referred for a CBCT examination using criteria in accordance with current European guidelines. The CBCT examinations were performed using similar equipment and standardized among clinics. After a thorough clinical examination, but before CBCT, the examiner made a preliminary therapy plan which was recorded. After the CBCT examination, the same examiner made a new therapy plan. Therapy plans both before and after the CBCT examination were plotted for 53 patients and 81 teeth. As four patients had incomplete protocols, they were not included in the final analysis. 4% of the patients referred to endodontic clinics during the study period were examined with CBCT. The most frequent reason for referral to CBCT examination was to differentiate pathology from normal anatomy, this was the case in 24 patients (45% of the cases). The primary outcome was therapy plan changes that could be attributed to CBCT examination. There were changes in 28 patients (53%). CBCT has a significant impact on therapeutic decision efficacy in endodontics when used in concordance with the current European Commission guidelines.

Reflections on clinical research in sub-Saharan Africa.

PubMed

Kuepfer, Irene; Burri, Christian

2009-07-15

The urgent need for new, safe and sustainable interventions against diseases that disproportionally affect the poor is finally receiving global attention and the funding landscape for development projects has significantly improved during the past decade. For the development of new drug and vaccine candidates, clinical trials have become the most important tool to assess their safety and efficacy. Recently, there has been a seismic shift in the number of clinical trials conducted in resource-limited settings. We discuss the current framework of clinical research in sub-Saharan Africa, from building product pipelines to the capacities needed for the conduct of trials according the harmonised Good Clinical Practice (GCP) ICH E6 guideline. We place emphasis on clinical research in neglected tropical diseases which still frequently has to be conducted with limited financial, logistical and human resources. Given those short-comings we recommend minimum standards needed at the local, national and sponsor levels to provide GCP-compliant clinical research.

Attributes of clinical leadership in contemporary nursing: an integrative review.

PubMed

Mannix, Judy; Wilkes, Lesley; Daly, John

2013-08-01

Effective clinical leadership is offered as the key to healthy, functional and supportive work environments for nurses and other health professionals. However, as a concept it lacks a standard definition and is poorly understood. This paper reports on an integrative review undertaken to uncover current understandings of defining attributes of contemporary clinical leadership in nursing. Data collection involved a search of relevant electronic databases for a 10-year period. Keywords for the search were 'clinical leadership' and 'nursing'. Ten research papers met the inclusion criteria for the integrative review. Analysis of these studies indicated clinical leadership attributes had a clinical focus, a follower/team focus or a personal qualities focus; attributes necessary to sustain supportive workplaces and build the capacity and resilience of nursing workforces. The small number of research-based studies yielded for the review indicates the need for further research in the area of clinical leadership.

Increasing patient safety and efficiency in transfusion therapy using formal process definitions.

PubMed

Henneman, Elizabeth A; Avrunin, George S; Clarke, Lori A; Osterweil, Leon J; Andrzejewski, Chester; Merrigan, Karen; Cobleigh, Rachel; Frederick, Kimberly; Katz-Bassett, Ethan; Henneman, Philip L

2007-01-01

The administration of blood products is a common, resource-intensive, and potentially problem-prone area that may place patients at elevated risk in the clinical setting. Much of the emphasis in transfusion safety has been targeted toward quality control measures in laboratory settings where blood products are prepared for administration as well as in automation of certain laboratory processes. In contrast, the process of transfusing blood in the clinical setting (ie, at the point of care) has essentially remained unchanged over the past several decades. Many of the currently available methods for improving the quality and safety of blood transfusions in the clinical setting rely on informal process descriptions, such as flow charts and medical algorithms, to describe medical processes. These informal descriptions, although useful in presenting an overview of standard processes, can be ambiguous or incomplete. For example, they often describe only the standard process and leave out how to handle possible failures or exceptions. One alternative to these informal descriptions is to use formal process definitions, which can serve as the basis for a variety of analyses because these formal definitions offer precision in the representation of all possible ways that a process can be carried out in both standard and exceptional situations. Formal process definitions have not previously been used to describe and improve medical processes. The use of such formal definitions to prospectively identify potential error and improve the transfusion process has not previously been reported. The purpose of this article is to introduce the concept of formally defining processes and to describe how formal definitions of blood transfusion processes can be used to detect and correct transfusion process errors in ways not currently possible using existing quality improvement methods.

The Current Status of Percutaneous Coronary Intervention in Korea: Based on Year 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry

PubMed Central

Jang, Jae-Sik; Han, Kyoo-Rok; Moon, Keon-Woong; Jeon, Dong Woon; Shin, Dong-Ho; Kim, Jung-Sun; Park, Duk-Woo; Kang, Hyun-Jae; Kim, Juhan; Bae, Jang-Whan; Hur, Seung-Ho; Kim, Byung Ok; Choi, Donghoon; Gwon, Hyeon-Cheol

2017-01-01

Background and Objectives Although several multicenter registries have evaluated percutaneous coronary intervention (PCI) procedures in Korea, those databases have been limited by non-standardized data collection and lack of uniform reporting methods. We aimed to collect and report data from a standardized database to analyze PCI procedures throughout the country. Materials and Methods Both clinical and procedural data, as well as clinical outcomes data during hospital stay, were collected based on case report forms that used a standard set of 54 data elements. This report is based on 2014 Korean PCI registry cohort data. Results A total of 92 hospitals offered data on 44967 PCI procedures. The median age was 66.0 interquartile range 57.0-74.0 years, and 70.3% were men. Thirty-eight percent of patients presented with acute myocardial infarction and one-third of all PCI procedures were performed in an urgent or emergency setting. Non-invasive stress tests were performed in 13.9% of cases, while coronary computed tomography angiography was used in 13.7% of cases prior to PCI. Radial artery access was used in 56.1% of all PCI procedures. Devices that used PCI included drug-eluting stent, plain old balloon angioplasty, drug-eluting balloon, and bare-metal stent (around 91%, 19%, 6%, and 1% of all procedures, respectively). The incidences of in-hospital death, non-fatal myocardial infarction, and stroke were 2.3%, 1.6%, and 0.2%, respectively. Conclusion These data may provide an overview of the current PCI practices and in-hospital outcomes in Korea and could be used as a foundation for developing treatment guidelines and nationwide clinical research. PMID:28567083

The Current Status of Percutaneous Coronary Intervention in Korea: Based on Year 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry.

PubMed

Jang, Jae-Sik; Han, Kyoo-Rok; Moon, Keon-Woong; Jeon, Dong Woon; Shin, Dong-Ho; Kim, Jung-Sun; Park, Duk-Woo; Kang, Hyun-Jae; Kim, Juhan; Bae, Jang-Whan; Hur, Seung-Ho; Kim, Byung Ok; Choi, Donghoon; Gwon, Hyeon-Cheol; Kim, Hyo-Soo

2017-05-01

Although several multicenter registries have evaluated percutaneous coronary intervention (PCI) procedures in Korea, those databases have been limited by non-standardized data collection and lack of uniform reporting methods. We aimed to collect and report data from a standardized database to analyze PCI procedures throughout the country. Both clinical and procedural data, as well as clinical outcomes data during hospital stay, were collected based on case report forms that used a standard set of 54 data elements. This report is based on 2014 Korean PCI registry cohort data. A total of 92 hospitals offered data on 44967 PCI procedures. The median age was 66.0 interquartile range 57.0-74.0 years, and 70.3% were men. Thirty-eight percent of patients presented with acute myocardial infarction and one-third of all PCI procedures were performed in an urgent or emergency setting. Non-invasive stress tests were performed in 13.9% of cases, while coronary computed tomography angiography was used in 13.7% of cases prior to PCI. Radial artery access was used in 56.1% of all PCI procedures. Devices that used PCI included drug-eluting stent, plain old balloon angioplasty, drug-eluting balloon, and bare-metal stent (around 91%, 19%, 6%, and 1% of all procedures, respectively). The incidences of in-hospital death, non-fatal myocardial infarction, and stroke were 2.3%, 1.6%, and 0.2%, respectively. These data may provide an overview of the current PCI practices and in-hospital outcomes in Korea and could be used as a foundation for developing treatment guidelines and nationwide clinical research.

An ontology-based approach to patient follow-up assessment for continuous and personalized chronic disease management.

PubMed

Zhang, Yi-Fan; Gou, Ling; Zhou, Tian-Shu; Lin, De-Nan; Zheng, Jing; Li, Ye; Li, Jing-Song

2017-08-01

Chronic diseases are complex and persistent clinical conditions that require close collaboration among patients and health care providers in the implementation of long-term and integrated care programs. However, current solutions focus partially on intensive interventions at hospitals rather than on continuous and personalized chronic disease management. This study aims to fill this gap by providing computerized clinical decision support during follow-up assessments of chronically ill patients at home. We proposed an ontology-based framework to integrate patient data, medical domain knowledge, and patient assessment criteria for chronic disease patient follow-up assessments. A clinical decision support system was developed to implement this framework for automatic selection and adaptation of standard assessment protocols to suit patient personal conditions. We evaluated our method in the case study of type 2 diabetic patient follow-up assessments. The proposed framework was instantiated using real data from 115,477 follow-up assessment records of 36,162 type 2 diabetic patients. Standard evaluation criteria were automatically selected and adapted to the particularities of each patient. Assessment results were generated as a general typing of patient overall condition and detailed scoring for each criterion, providing important indicators to the case manager about possible inappropriate judgments, in addition to raising patient awareness of their disease control outcomes. Using historical data as the gold standard, our system achieved a rate of accuracy of 99.93% and completeness of 95.00%. This study contributes to improving the accessibility, efficiency and quality of current patient follow-up services. It also provides a generic approach to knowledge sharing and reuse for patient-centered chronic disease management. Copyright © 2017 Elsevier Inc. All rights reserved.

Accuracy of point-of-care serum creatinine devices for detecting patients at risk of contrast-induced nephropathy: a critical overview.

PubMed

Martínez Lomakin, Felipe; Tobar, Catalina

2014-12-01

Contrast-induced nephropathy (CIN) is a common event in hospitals, with reported incidences ranging from 1 to 30%. Patients with underlying kidney disease have an increased risk of developing CIN. Point-of-care (POC) creatinine devices are handheld devices capable of providing quantitative data on a patient's kidney function that could be useful in stratifying preventive measures. This overview aims to synthesize the current evidence on diagnostic accuracy and clinical utility of POC creatinine devices in detecting patients at risk of CIN. Five databases were searched for diagnostic accuracy studies or clinical trials that evaluated the usefulness of POC devices in detecting patients at risk of CIN. Selected articles were critically appraised to assess their individual risk of bias by the use of standard criteria; 13 studies were found that addressed the diagnostic accuracy or clinical utility of POC creatinine devices. Most studies incurred a moderate to high risk of bias. Overall concordance between POC devices and reference standards (clinical laboratory procedures) was found to be moderate, with 95% limits of agreement often lying between -35.4 and +35.4 µmol/L (-0.4 and +0.4 mg/dL). Concordance was shown to decrease with worsening kidney function. Data on the clinical utility of these devices were limited, but a significant reduction in time to diagnosis was reported in two studies. Overall, POC creatinine devices showed a moderate concordance with standard clinical laboratory creatinine measurements. Several biases could have induced optimism in these estimations. Results obtained from these devices may be unreliable in cases of severe kidney failure. Randomized trials are needed to address the clinical utility of these devices.

Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology.

PubMed

Basch, Ethan; Abernethy, Amy P; Mullins, C Daniel; Reeve, Bryce B; Smith, Mary Lou; Coons, Stephen Joel; Sloan, Jeff; Wenzel, Keith; Chauhan, Cynthia; Eppard, Wayland; Frank, Elizabeth S; Lipscomb, Joseph; Raymond, Stephen A; Spencer, Merianne; Tunis, Sean

2012-12-01

Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.

Dedicated dental volumetric and total body multislice computed tomography: a comparison of image quality and radiation dose

NASA Astrophysics Data System (ADS)

Strocchi, Sabina; Colli, Vittoria; Novario, Raffaele; Carrafiello, Gianpaolo; Giorgianni, Andrea; Macchi, Aldo; Fugazzola, Carlo; Conte, Leopoldo

2007-03-01

Aim of this work is to compare the performances of a Xoran Technologies i-CAT Cone Beam CT for dental applications with those of a standard total body multislice CT (Toshiba Aquilion 64 multislice) used for dental examinations. Image quality and doses to patients have been compared for the three main i-CAT protocols, the Toshiba standard protocol and a Toshiba modified protocol. Images of two phantoms have been acquired: a standard CT quality control phantom and an Alderson Rando ® anthropomorphic phantom. Image noise, Signal to Noise Ratio (SNR), Contrast to Noise Ratio (CNR) and geometric accuracy have been considered. Clinical image quality was assessed. Effective dose and doses to main head and neck organs were evaluated by means of thermo-luminescent dosimeters (TLD-100) placed in the anthropomorphic phantom. A Quality Index (QI), defined as the ratio of squared CNR to effective dose, has been evaluated. The evaluated effective doses range from 0.06 mSv (i-CAT 10 s protocol) to 2.37 mSv (Toshiba standard protocol). The Toshiba modified protocol (halved tube current, higher pitch value) imparts lower effective dose (0.99 mSv). The conventional CT device provides lower image noise and better SNR, but clinical effectiveness similar to that of dedicated dental CT (comparable CNR and clinical judgment). Consequently, QI values are much higher for this second CT scanner. No geometric distortion has been observed with both devices. As a conclusion, dental volumetric CT supplies adequate image quality to clinical purposes, at doses that are really lower than those imparted by a conventional CT device.

Monitoring surgical and medical outcomes: the Bernoulli cumulative SUM chart. A novel application to assess clinical interventions

PubMed Central

Leandro, G; Rolando, N; Gallus, G; Rolles, K; Burroughs, A

2005-01-01

Background: Monitoring clinical interventions is an increasing requirement in current clinical practice. The standard CUSUM (cumulative sum) charts are used for this purpose. However, they are difficult to use in terms of identifying the point at which outcomes begin to be outside recommended limits. Objective: To assess the Bernoulli CUSUM chart that permits not only a 100% inspection rate, but also the setting of average expected outcomes, maximum deviations from these, and false positive rates for the alarm signal to trigger. Methods: As a working example this study used 674 consecutive first liver transplant recipients. The expected one year mortality set at 24% from the European Liver Transplant Registry average. A standard CUSUM was compared with Bernoulli CUSUM: the control value mortality was therefore 24%, maximum accepted mortality 30%, and average number of observations to signal was 500—that is, likelihood of false positive alarm was 1:500. Results: The standard CUSUM showed an initial descending curve (nadir at patient 215) then progressively ascended indicating better performance. The Bernoulli CUSUM gave three alarm signals initially, with easily recognised breaks in the curve. There were no alarms signals after patient 143 indicating satisfactory performance within the criteria set. Conclusions: The Bernoulli CUSUM is more easily interpretable graphically and is more suitable for monitoring outcomes than the standard CUSUM chart. It only requires three parameters to be set to monitor any clinical intervention: the average expected outcome, the maximum deviation from this, and the rate of false positive alarm triggers. PMID:16210461

Accurate and Standardized Coronary Wave Intensity Analysis.

PubMed

Rivolo, Simone; Patterson, Tiffany; Asrress, Kaleab N; Marber, Michael; Redwood, Simon; Smith, Nicolas P; Lee, Jack

2017-05-01

Coronary wave intensity analysis (cWIA) has increasingly been applied in the clinical research setting to distinguish between the proximal and distal mechanical influences on coronary blood flow. Recently, a cWIA-derived clinical index demonstrated prognostic value in predicting functional recovery postmyocardial infarction. Nevertheless, the known operator dependence of the cWIA metrics currently hampers its routine application in clinical practice. Specifically, it was recently demonstrated that the cWIA metrics are highly dependent on the chosen Savitzky-Golay filter parameters used to smooth the acquired traces. Therefore, a novel method to make cWIA standardized and automatic was proposed and evaluated in vivo. The novel approach combines an adaptive Savitzky-Golay filter with high-order central finite differencing after ensemble-averaging the acquired waveforms. Its accuracy was assessed using in vivo human data. The proposed approach was then modified to automatically perform beat wise cWIA. Finally, the feasibility (accuracy and robustness) of the method was evaluated. The automatic cWIA algorithm provided satisfactory accuracy under a wide range of noise scenarios (≤10% and ≤20% error in the estimation of wave areas and peaks, respectively). These results were confirmed when beat-by-beat cWIA was performed. An accurate, standardized, and automated cWIA was developed. Moreover, the feasibility of beat wise cWIA was demonstrated for the first time. The proposed algorithm provides practitioners with a standardized technique that could broaden the application of cWIA in the clinical practice as enabling multicenter trials. Furthermore, the demonstrated potential of beatwise cWIA opens the possibility investigating the coronary physiology in real time.

Pulse oximetry-derived respiratory rate in general care floor patients.

PubMed

Addison, Paul S; Watson, James N; Mestek, Michael L; Ochs, James P; Uribe, Alberto A; Bergese, Sergio D

2015-02-01

Respiratory rate is recognized as a clinically important parameter for monitoring respiratory status on the general care floor (GCF). Currently, intermittent manual assessment of respiratory rate is the standard of care on the GCF. This technique has several clinically-relevant shortcomings, including the following: (1) it is not a continuous measurement, (2) it is prone to observer error, and (3) it is inefficient for the clinical staff. We report here on an algorithm designed to meet clinical needs by providing respiratory rate through a standard pulse oximeter. Finger photoplethysmograms were collected from a cohort of 63 GCF patients monitored during free breathing over a 25-min period. These were processed using a novel in-house algorithm based on continuous wavelet-transform technology within an infrastructure incorporating confidence-based averaging and logical decision-making processes. The computed oximeter respiratory rates (RRoxi) were compared to an end-tidal CO2 reference rate (RRETCO2). RRETCO2 ranged from a lowest recorded value of 4.7 breaths per minute (brpm) to a highest value of 32.0 brpm. The mean respiratory rate was 16.3 brpm with standard deviation of 4.7 brpm. Excellent agreement was found between RRoxi and RRETCO2, with a mean difference of -0.48 brpm and standard deviation of 1.77 brpm. These data demonstrate that our novel respiratory rate algorithm is a potentially viable method of monitoring respiratory rate in GCF patients. This technology provides the means to facilitate continuous monitoring of respiratory rate, coupled with arterial oxygen saturation and pulse rate, using a single non-invasive sensor in low acuity settings.

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

PubMed

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.

Bioreactor Engineering of Stem Cell Environments

PubMed Central

Tandon, Nina; Marolt, Darja; Cimetta, Elisa; Vunjak-Novakovic, Gordana

2013-01-01

Stem cells hold promise to revolutionize modern medicine by development of new therapies, disease models and drug screening systems. Standard cell culture systems have limited biological relevance because they do not recapitulate the complex 3-dimensional interactions and biophysical cues that characterize the in vivo environment. In this review, we discuss the current advances in engineering stem cell environments using novel biomaterials and bioreactor technologies. We also reflect on the challenges the field is currently facing with regard to translation of stem cell based therapies into the clinic. PMID:23531529

Clinical interpretation of opioid tolerance versus opioid-induced hyperalgesia.

PubMed

Chen, Lucy; Sein, Michael; Vo, Trang; Amhmed, Shihab; Zhang, Yi; Hilaire, Kristin St; Houghton, Mary; Mao, Jianren

2014-01-01

Opioid analgesics are commonly used to manage moderate to severe pain. However, the long-term use of opioids could lead to opioid tolerance (OT) and opioid-induced hyperalgesia (OIH). Distinguishing OIH from OT would impact the practice of opioid therapy because opioid dose adjustment may differentially influence OT and OIH. Currently, there are no standard criteria of OT versus OIH causing considerable ambiguity in clinical interpretation and management of these conditions. The authors designed a practitioner-based survey consisting of 20 targeted questions. Answering these questions would require responders' actual clinical experiences with opioid therapy. The survey was conducted between 2011 and 2012 through direct mails or e-mails to 1,408 physicians who are currently practicing in the United States. The authors find that certain clinical characteristics (eg, increased pain despite opioid dose escalation) are often used by practitioners to make differential diagnosis of OT and OIH despite some overlap in their clinical presentation. A key difference in clinical outcome is that OT and OIH could be improved and exacerbated by opioid dose escalation, respectively. Our survey results revealed a significant knowledge gap in some responders regarding differential diagnosis and management of OT and OIH. The results also identified several issues, such as opioid dose adjustment and clinical comorbidities related to OT and OIH, which require future patient-based studies.

National Survey of Adult and Pediatric Reference Intervals in Clinical Laboratories across Canada: A Report of the CSCC Working Group on Reference Interval Harmonization.

PubMed

Adeli, Khosrow; Higgins, Victoria; Seccombe, David; Collier, Christine P; Balion, Cynthia M; Cembrowski, George; Venner, Allison A; Shaw, Julie

2017-11-01

Reference intervals are widely used decision-making tools in laboratory medicine, serving as health-associated standards to interpret laboratory test results. Numerous studies have shown wide variation in reference intervals, even between laboratories using assays from the same manufacturer. Lack of consistency in either sample measurement or reference intervals across laboratories challenges the expectation of standardized patient care regardless of testing location. Here, we present data from a national survey conducted by the Canadian Society of Clinical Chemists (CSCC) Reference Interval Harmonization (hRI) Working Group that examines variation in laboratory reference sample measurements, as well as pediatric and adult reference intervals currently used in clinical practice across Canada. Data on reference intervals currently used by 37 laboratories were collected through a national survey to examine the variation in reference intervals for seven common laboratory tests. Additionally, 40 clinical laboratories participated in a baseline assessment by measuring six analytes in a reference sample. Of the seven analytes examined, alanine aminotransferase (ALT), alkaline phosphatase (ALP), and creatinine reference intervals were most variable. As expected, reference interval variation was more substantial in the pediatric population and varied between laboratories using the same instrumentation. Reference sample results differed between laboratories, particularly for ALT and free thyroxine (FT4). Reference interval variation was greater than test result variation for the majority of analytes. It is evident that there is a critical lack of harmonization in laboratory reference intervals, particularly for the pediatric population. Furthermore, the observed variation in reference intervals across instruments cannot be explained by the bias between the results obtained on instruments by different manufacturers. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Economic Implications of Potential Changes to Regulatory and Reimbursement Policies for Medical Devices

PubMed Central

Reed, Shelby D.; Shea, Alisa M.

2007-01-01

Objective To evaluate the impact of regulatory scenarios on the financial viability of medical device companies. Design We developed a model to calculate the expected net present value of a hypothetical product throughout preclinical development, clinical testing, regulatory approval, and postmarketing. We tested 3 scenarios: (1) the current regulatory environment; (2) a scenario in which medical devices are subject to the same evidence standards required for pharmaceuticals; and (3) a scenario consistent with the Coverage with Evidence Development: Coverage with Study Participation (CSP) policy proposed by the Centers for Medicare and Medicaid Services, whereby Medicare will pay for beneficiaries to receive new devices that are not currently determined to be “reasonable and necessary” if the patients participate in clinical studies or registries. Measurements and Main results When applying assumptions consistent with the implantable cardioverter-defibrillator market, the net present value at the start of development was an estimated $553 million in the current regulatory environment, $322 million in the pharmaceutical scenario, and $403 million in the CSP scenario. Sensitivity analyses showed that the device industry would likely be profitable in all 3 scenarios over a range of assumptions. Conclusions The environment in which the medical device industry operates is financially attractive. Furthermore, when compared with the alternative of applying the same evidence standards for pharmaceuticals to medical devices, the CSP policy offers improved financial incentives for medical device companies. PMID:18095045

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.

PubMed

Beyer-Westendorf, Jan; Camm, A John; Coleman, Craig I; Tamayo, Sally

2016-09-28

Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

An assessment of the current treatment landscape for rheumatology patients in Qatar: Recognising unmet needs and moving towards solutions.

PubMed

Emadi, Samar Al; Hammoudeh, Mohammed; Mounir, Mohamed; Mueller, Ruediger B; Wells, Alvin F; Sarakbi, Housam Aldeen

2017-04-01

Objective This study assessed the mode of application (oral, intravenous or subcutaneous (SC)) currently employed in the treatment of rheumatoid arthritis (RA) in patients from Qatar in comparison with patients' individual preferences for the mode of application of their treatment. Methods This study included 294 RA patients visiting three clinics at the main referral hospital in Qatar who were interviewed using a standard questionnaire to determine their preference of mode of application for their disease-modifying antirheumatic drug (DMARD) treatment in relation to their currently employed mode of application. Results The majority of patients were female (76%), and 93% of male patients and 61% of female patients in the study clinics were of a nationality other than Qatari. The highest patient preference recorded was for an oral therapy (69%), compared with injection (23%) and intravenous (8%) therapy. In total, 85% of patients expressed a preference to remain on oral therapy compared with 63% and 58% of intravenous and SC injection patients indicating a preference to remain on their current method of administration. Conclusions This high preference for oral therapies highlights the considerable need for incorporation of new oral targeted synthetic DMARD therapies into clinical practice within the region.

An assessment of the current treatment landscape for rheumatology patients in Qatar: Recognising unmet needs and moving towards solutions

PubMed Central

Hammoudeh, Mohammed; Mounir, Mohamed; Mueller, Ruediger B.; Wells, Alvin F.; Sarakbi, Housam Aldeen

2017-01-01

Objective This study assessed the mode of application (oral, intravenous or subcutaneous (SC)) currently employed in the treatment of rheumatoid arthritis (RA) in patients from Qatar in comparison with patients’ individual preferences for the mode of application of their treatment. Methods This study included 294 RA patients visiting three clinics at the main referral hospital in Qatar who were interviewed using a standard questionnaire to determine their preference of mode of application for their disease-modifying antirheumatic drug (DMARD) treatment in relation to their currently employed mode of application. Results The majority of patients were female (76%), and 93% of male patients and 61% of female patients in the study clinics were of a nationality other than Qatari. The highest patient preference recorded was for an oral therapy (69%), compared with injection (23%) and intravenous (8%) therapy. In total, 85% of patients expressed a preference to remain on oral therapy compared with 63% and 58% of intravenous and SC injection patients indicating a preference to remain on their current method of administration. Conclusions This high preference for oral therapies highlights the considerable need for incorporation of new oral targeted synthetic DMARD therapies into clinical practice within the region. PMID:28415924

Standard skin prick testing and sensitization to inhalant allergens across Europe--a survey from the GALEN network.

PubMed

Heinzerling, L; Frew, A J; Bindslev-Jensen, C; Bonini, S; Bousquet, J; Bresciani, M; Carlsen, K-H; van Cauwenberge, P; Darsow, U; Fokkens, W J; Haahtela, T; van Hoecke, H; Jessberger, B; Kowalski, M L; Kopp, T; Lahoz, C N; Lodrup Carlsen, K C; Papadopoulos, N G; Ring, J; Schmid-Grendelmeier, P; Vignola, A M; Wöhrl, S; Zuberbier, T

2005-10-01

Skin prick testing (SPT) is the standard method for diagnosing allergic sensitization but is to some extent performed differently in clinical centres across Europe. There would be advantages in harmonizing the standard panels of allergens used in different European countries, both for clinical purposes and for research, especially with increasing mobility within Europe and current trends in botany and agriculture. As well as improving diagnostic accuracy, this would allow better comparison of research findings in European allergy centres. We have compared the different SPT procedures operating in 29 allergy centres within the Global Allergy and Asthma European Network (GA(2)LEN). Standard SPT is performed similarly in all centres, e.g. using commercial extracts, evaluation after 15-20 min exposure with positive results defined as a wheal >3 mm diameter. The perennial allergens included in the standard SPT panel of inhalant allergens are largely similar (e.g. cat: pricked in all centres; dog: 26 of 29 centres and Dermatophagoides pteronyssinus: 28 of 29 centres) but the choice of pollen allergens vary considerably, reflecting different exposure and sensitization rates for regional inhalant allergens. This overview may serve as reference for the practising doctor and suggests a GA(2)LEN Pan-European core SPT panel.

Clinical trials bureaucracy: unintended consequences of well-intentioned policy.

PubMed

Califf, Robert M

2006-01-01

As randomized controlled trials have become the 'gold standard' for medical research, a complex regulatory structure for the conduct of clinical trials has emerged. However, this structure has not been adequately assessed to ensure that regulations governing human subjects research actually produce the desired effects. Our purpose is to identify some of the major shortcomings in the current regulatory system of human clinical trials oversight, and to propose some potential solutions to these problems. We discuss the evolution of the current US regulatory environment and its application in the context of several widely-used drug therapies. Despite numerous randomized controlled trials, performed within a structure of extensive documentation and data collection, serious shortcomings in a number of pharmaceutical therapies were not detected until after the drugs were approved and widely adopted by clinicians. The current system of regulatory bureaucracy in clinical trials has led to an extremely expensive research paradigm that, in spite of complex systems of oversight and exhaustive data collection, cannot be shown to adequately ensure the integrity of the research process and the protection of human research subjects. Some parts of the system, including Research Ethics Review Boards, may not be well-suited to carrying out their core mission of overseeing research conduct, and other aspects of clinical trials regulatory structure, such as monitoring/auditing review and adverse event reporting, may constitute a waste of money and resources. Misdirected data collection and adverse events reporting divert valuable resources and hamper development of large, simple clinical trials powered to definitively answer important research questions. Careful scrutiny of the utility of current or proposed regulatory schemes is required to ensure the integrity of human subjects research and to enhance the effectiveness of research dollars.

Guidelines for the Standardization of Genital Photography.

PubMed

Joumblat, Natalie R; Chim, Jimmy; Sanchez Aguirre, Priscila Gisselle; Bedolla, Edgar; Salgado, Christopher J

2018-02-06

Plastic surgery relies on photography for both clinical practice and research. The Photographic Standards in Plastic Surgery laid the foundation for standardized photography in plastic surgery. Despite these advancements, the current literature lacks guidelines for genital photography, thus resulting in a discordance of documentation. The authors propose photographic standards for the male and female genitalia to establish homogeneity in which information can be accurately exchanged. All medical photographs include a sky-blue background, proper lighting, removal of distractors, consistent camera framing, and standard camera angles. We propose the following guidelines to standardize genital photography. In the anterior upright position, feet are shoulder-width apart and arms are placed posteriorly. The frame is bounded superiorly by the xiphoid-umbilicus midpoint and inferiorly by the patella. For circumferential documentation, frontal 180 degree capture via 45 degree intervals is often sufficient. Images in standard lithotomy position should be captured at both parallel and 45 degrees above the horizontal. Images of the phallus should include both the flaccid and erect states. Despite the increasing incidence of genital procedures, there lacks a standardized methodology in which to document the genitalia, resulting in a substantial heterogeneity in the current literature. Our standardized techniques for genital photography set forth to establish a uniform language that promotes more effective communication with both the patient as well as with colleagues. The proposed photography guidelines provide optimal visualization and standard documentation of the genitalia, allowing for accurate education, meaningful collaborations, and advancement in genital surgery. © 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

[Medical nutrition in Alzheimer's: the trials].

PubMed

Scheltens, Philip; Twisk, Jos W R

2013-01-01

We describe the small but statistically significant effects of the medical nutrition diet 'Souvenaid' on memory in early Alzheimer's disease in two published randomised clinical trials. We specifically discuss the design and statistical approach, which were predefined and meet current standards in the field. Further research is needed to substantiate the long term effects and learn more about the mode of action of Souvenaid.

Model-Based, Noninvasive Monitoring of Intracranial Pressure

DTIC Science & Technology

2013-07-01

patients. A physiologically based model relates ICP to simultaneously measured waveforms of arterial blood pressure ( ABP ), obtained via radial... ABP and CBFV are currently measured as the clinical standard of care. The project’s major accomplishments include: assembling a suitable system for...synchronized arterial blood pressure ( ABP ) and cerebral blood flow velocity (CBFV) waveform measurements that can be obtained quite routinely. Our processing

The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility.

PubMed

Arjmand, Babak; Emami-Razavi, Seyed Hassan; Larijani, Bagher; Norouzi-Javidan, Abbas; Aghayan, Hamid Reza

2012-12-01

Cell manufacturing for clinical applications is a unique form of biologics manufacturing that relies on maintenance of stringent work practices designed to ensure product consistency and prevent contamination by microorganisms or by another patient's cells. More extensive, prolonged laboratory processes involve greater risk of complications and possibly adverse events for the recipient, and so the need for control is correspondingly greater. To minimize the associate risks of cell manufacturing adhering to international quality standards is critical. Current good tissue practice (cGTP) and current good manufacturing practice (cGMP) are examples of general standards that draw a baseline for cell manufacturing facilities. In recent years, stem cell researches have found great public interest in Iran and different cell therapy projects have been started in country. In this review we described the role of our tissue banking experiences in establishing a new cGMP cell manufacturing facility. The authors concluded that, tissue banks and tissue banking experts can broaden their roles from preparing tissue grafts to manufacturing cell and tissue engineered products for translational researches and phase I clinical trials. Also they can collaborate with cell processing laboratories to develop SOPs, implement quality management system, and design cGMP facilities.

Psychoactive constituents of cannabis and their clinical implications: a systematic review.

PubMed

Casajuana Köguel, Cristina; López-Pelayo, Hugo; Balcells-Olivero, Mª Mercedes; Colom, Joan; Gual, Antoni

2018-04-15

Objective This systematic review aims to summarize current evidence on which naturally present cannabinoids contribute to cannabis psychoactivity, considering their reported concentrations and pharmacodynamics in humans. Design Following PRISMA guidelines, papers published before March 2016 in Medline, Scopus-Elsevier, Scopus, ISI-Web of Knowledge and COCHRANE, and fulfilling established a-priori selection criteria have been included. Results In 40 original papers, three naturally present cannabinoids (∆-9-Tetrahydrocannabinol, ∆-8-Tetrahydrocannabinol and Cannabinol) and one human metabolite (11-OH-THC) had clinical relevance. Of these, the metabolite produces the greatest psychoactive effects. Cannabidiol (CBD) is not psychoactive but plays a modulating role on cannabis psychoactive effects. The proportion of 9-THC in plant material is higher (up to 40%) than in other cannabinoids (up to 9%). Pharmacodynamic reports vary due to differences in methodological aspects (doses, administration route and volunteers' previous experience with cannabis). Conclusions Findings reveal that 9-THC contributes the most to cannabis psychoactivity. Due to lower psychoactive potency and smaller proportions in plant material, other psychoactive cannabinoids have a weak influence on cannabis final effects. Current lack of standard methodology hinders homogenized research on cannabis health effects. Working on a standard cannabis unit considering 9-THC is recommended.

Simple, Sensitive and Accurate Multiplex Detection of Clinically Important Melanoma DNA Mutations in Circulating Tumour DNA with SERS Nanotags

PubMed Central

Wee, Eugene J.H.; Wang, Yuling; Tsao, Simon Chang-Hao; Trau, Matt

2016-01-01

Sensitive and accurate identification of specific DNA mutations can influence clinical decisions. However accurate diagnosis from limiting samples such as circulating tumour DNA (ctDNA) is challenging. Current approaches based on fluorescence such as quantitative PCR (qPCR) and more recently, droplet digital PCR (ddPCR) have limitations in multiplex detection, sensitivity and the need for expensive specialized equipment. Herein we describe an assay capitalizing on the multiplexing and sensitivity benefits of surface-enhanced Raman spectroscopy (SERS) with the simplicity of standard PCR to address the limitations of current approaches. This proof-of-concept method could reproducibly detect as few as 0.1% (10 copies, CV < 9%) of target sequences thus demonstrating the high sensitivity of the method. The method was then applied to specifically detect three important melanoma mutations in multiplex. Finally, the PCR/SERS assay was used to genotype cell lines and ctDNA from serum samples where results subsequently validated with ddPCR. With ddPCR-like sensitivity and accuracy yet at the convenience of standard PCR, we believe this multiplex PCR/SERS method could find wide applications in both diagnostics and research. PMID:27446486

Simple, Sensitive and Accurate Multiplex Detection of Clinically Important Melanoma DNA Mutations in Circulating Tumour DNA with SERS Nanotags.

PubMed

Wee, Eugene J H; Wang, Yuling; Tsao, Simon Chang-Hao; Trau, Matt

2016-01-01

Sensitive and accurate identification of specific DNA mutations can influence clinical decisions. However accurate diagnosis from limiting samples such as circulating tumour DNA (ctDNA) is challenging. Current approaches based on fluorescence such as quantitative PCR (qPCR) and more recently, droplet digital PCR (ddPCR) have limitations in multiplex detection, sensitivity and the need for expensive specialized equipment. Herein we describe an assay capitalizing on the multiplexing and sensitivity benefits of surface-enhanced Raman spectroscopy (SERS) with the simplicity of standard PCR to address the limitations of current approaches. This proof-of-concept method could reproducibly detect as few as 0.1% (10 copies, CV < 9%) of target sequences thus demonstrating the high sensitivity of the method. The method was then applied to specifically detect three important melanoma mutations in multiplex. Finally, the PCR/SERS assay was used to genotype cell lines and ctDNA from serum samples where results subsequently validated with ddPCR. With ddPCR-like sensitivity and accuracy yet at the convenience of standard PCR, we believe this multiplex PCR/SERS method could find wide applications in both diagnostics and research.

Cachexia and pancreatic cancer: Are there treatment options?

PubMed Central

Mueller, Tara C; Burmeister, Marc A; Bachmann, Jeannine; Martignoni, Marc E

2014-01-01

Cachexia is frequently described in patients with pancreatic ductal adenocarcinoma (PDAC) and is associated with reduced survival and quality of life. Unfortunately, the therapeutic options of this multi-factorial and complex syndrome are limited. This is due to the fact that, despite extensive preclinical and clinical research, the underlying pathological mechanisms leading to PDAC-associated cachexia are still not fully understood. Furthermore, there is still a lack of consensus on the definition of cachexia, which complicates the standardization of diagnosis and treatment as well as the analysis of the current literature. In order to provide an efficient therapy for cachexia, an early and reliable diagnosis and consistent monitoring is required, which can be challenging especially in obese patients. Although many substances have been tested in clinical and preclinical settings, so far none of them have been proven to have a long-term effect in ameliorating cancer-associated cachexia. However, recent studies have demonstrated that multidimensional therapeutic modalities are able to alleviate pancreatic cancer-associated cachexia and ultimately improve patients’ outcome. In this current review, we propose a stepwise and pragmatic approach to facilitate and standardize the treatment of cachexia in pancreatic cancer patients. This strategy consists of nutritional, dietary, pharmacological, physical and psychological methods. PMID:25071331

Diagnostics and Treatment of Hepatocellular Carcinoma in 2016: Standards and Developments.

PubMed

Trojan, Jörg; Zangos, Stephan; Schnitzbauer, Andreas A

2016-04-01

Hepatocellular carcinoma (HCC) is a frequent complication of liver cirrhosis. Worldwide, HCC is one of the most common cancers, with a rising incidence. A selective literature search was conducted, taking into account current studies, reviews, meta-analyses, and guidelines. The diagnosis is established either non-invasively by dynamic imaging, showing a typical contrast enhancement and wash-out, or histopathologically. Pathological diagnosis of HCC is recommended for all atypical nodules in patients with cirrhosis and for those in non-cirrhotic patients. Tumor therapy as well as treatment of the underlying chronic liver disease and/or preservation of liver function are important for the management of patients with HCC. Standard stage-adapted treatments are based on the widely applied Barcelona Clinic Liver Cancer staging system including liver resection and transplantation, interventional treatments such as thermal ablation and transarterial therapies, and systemic treatment with the tyrosine kinase inhibitor sorafenib. After failure of sorafenib, anti-angiogenic drugs, MET inhibitors, and immunotherapeutics are currently under advanced clinical investigation. Treatment of HCC is multidisciplinary and therefore requires a close cooperation between various disciplines such as hepatology, visceral surgery, radiology, and oncology to achieve the best outcome depending on the tumor stage and degree of liver function impairment.

Liver safety assessment in special populations (hepatitis B, C, and oncology trials).

PubMed

Kullak-Ublick, Gerd A; Merz, Michael; Griffel, Louis; Kaplowitz, Neil; Watkins, Paul B

2014-11-01

The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver injury (DILI) is the most specific regulatory guidance currently available and has been useful in setting standards for the great majority of clinical indications involving subjects with a low risk of liver disorders. However, liver safety assessment faces challenges in populations with underlying liver disease, such as viral hepatitis or metastatic cancer. This is an important issue because there are currently many promising anti-viral and oncologic therapies in clinical development, with a trend toward oral therapies with reduced side effects. Without clearer guidelines, questions regarding liver safety may become a major factor in regulatory approval and ultimately physician uptake of the new treatments. The lack of consensus in defining stopping rules based on serum alanine aminotransferase (ALT) levels underscores the need for precompetitive data sharing to improve our understanding of DILI in these populations and to allow evidence-based rather than empirical definition of stopping rules. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument.

PubMed

Mokkink, Lidwine B; Prinsen, Cecilia A C; Bouter, Lex M; Vet, Henrica C W de; Terwee, Caroline B

2016-01-19

COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument

PubMed Central

Mokkink, Lidwine B.; Prinsen, Cecilia A. C.; Bouter, Lex M.; de Vet, Henrica C. W.; Terwee, Caroline B.

2016-01-01

Background: COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. Method: In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. Conclusions: In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments. PMID:26786084

ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

PubMed

Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

Evaluation of clinical methods for diagnosing bacterial vaginosis.

PubMed

Gutman, Robert E; Peipert, Jeffrey F; Weitzen, Sherry; Blume, Jeffrey

2005-03-01

To determine whether the current clinical criteria for diagnosing bacterial vaginosis can be simplified by using 2 clinical criteria rather than the standard 3 of 4 criteria (Amsel's criteria). This was a prospective observational study of 269 women undergoing a vaginal examination in the Women's Primary Care Center, Division of Research, or Colposcopy Clinic at Women & Infants Hospital. All 4 clinical criteria for diagnosing bacterial vaginosis were collected, and Gram stain was used as the gold standard. Sensitivity and specificity were calculated for each individual criterion, combinations of criteria, and a colorimetric pH and amine card. Receiver operating characteristic curve was generated to estimate the preferred pH and percentage of clue cells for diagnosing bacterial vaginosis. The prevalence of bacterial vaginosis in our study population was 38.7%. Vaginal pH was the most sensitive of all the criteria, at 89%, and a positive amine odor was the individual criteria with the highest specificity, at 93%. Similar specificity was seen with combinations of 2 criteria and Amsel's criteria. Receiver operating characteristic curve analysis yielded a preferred pH and percentage of clue cells of 5.0 and 20%, respectively. However, a pH of 4.5 or greater improves sensitivity with minimal loss of specificity. The clinical criteria for diagnosing bacterial vaginosis can be simplified to 2 clinical criteria without loss of sensitivity and specificity.

FDG-PET imaging in mild traumatic brain injury: a critical review

PubMed Central

Byrnes, Kimberly R.; Wilson, Colin M.; Brabazon, Fiona; von Leden, Ramona; Jurgens, Jennifer S.; Oakes, Terrence R.; Selwyn, Reed G.

2013-01-01

Traumatic brain injury (TBI) affects an estimated 1.7 million people in the United States and is a contributing factor to one third of all injury related deaths annually. According to the CDC, approximately 75% of all reported TBIs are concussions or considered mild in form, although the number of unreported mild TBIs (mTBI) and patients not seeking medical attention is unknown. Currently, classification of mTBI or concussion is a clinical assessment since diagnostic imaging is typically inconclusive due to subtle, obscure, or absent changes in anatomical or physiological parameters measured using standard magnetic resonance (MR) or computed tomography (CT) imaging protocols. Molecular imaging techniques that examine functional processes within the brain, such as measurement of glucose uptake and metabolism using [18F]fluorodeoxyglucose and positron emission tomography (FDG-PET), have the ability to detect changes after mTBI. Recent technological improvements in the resolution of PET systems, the integration of PET with magnetic resonance imaging (MRI), and the availability of normal healthy human databases and commercial image analysis software contribute to the growing use of molecular imaging in basic science research and advances in clinical imaging. This review will discuss the technological considerations and limitations of FDG-PET, including differentiation between glucose uptake and glucose metabolism and the significance of these measurements. In addition, the current state of FDG-PET imaging in assessing mTBI in clinical and preclinical research will be considered. Finally, this review will provide insight into potential critical data elements and recommended standardization to improve the application of FDG-PET to mTBI research and clinical practice. PMID:24409143

Ambient lighting: setting international standards for the viewing of softcopy chest images

NASA Astrophysics Data System (ADS)

McEntee, Mark F.; Ryan, John; Evanoff, Micheal G.; Keeling, Aoife; Chakraborty, Dev; Manning, David; Brennan, Patrick C.

2007-03-01

Clinical radiological judgments are increasingly being made on softcopy LCD monitors. These monitors are found throughout the hospital environment in radiological reading rooms, outpatient clinics and wards. This means that ambient lighting where clinical judgments from images are made can vary widely. Inappropriate ambient lighting has several deleterious effects: monitor reflections reduce contrast; veiling glare adds brightness; dynamic range and detectability of low contrast objects is limited. Radiological images displayed on LCDs are more sensitive to the impact of inappropriate ambient lighting and with these devices problems described above are often more evident. The current work aims to provide data on optimum ambient lighting, based on lesions within chest images. The data provided may be used for the establishment of workable ambient lighting standards. Ambient lighting at 30cms from the monitor was set at 480 Lux (office lighting) 100 Lux (WHO recommendations), 40 Lux and <10 Lux. All monitors were calibrated to DICOM part 14 GSDF. Sixty radiologists were presented with 30 chest images, 15 images having simulated nodular lesions of varying subtlety and size. Lesions were positioned in accordance with typical clinical presentation and were validated radiologically. Each image was presented for 30 seconds and viewers were asked to identify and score any visualized lesion from 1-4 to indicate confidence level of detection. At the end of the session, sensitivity and specificity were calculated. Analysis of the data suggests that visualization of chest lesions is affected by inappropriate lighting with chest radiologists demonstrating greater ambient lighting dependency. JAFROC analyses are currently being performed.

Core competencies in clinical neuropsychology training across the world.

PubMed

Hessen, Erik; Hokkanen, Laura; Ponsford, Jennie; van Zandvoort, Martine; Watts, Ann; Evans, Jonathan; Haaland, Kathleen Y

2018-05-01

This work aimed to review main competency requirements from training models in countries with well-established specialties in clinical neuropsychology and to extract core competencies that likely will apply to clinical neuropsychologists regardless of regional and cultural context. We reviewed standards for post-graduate training in clinical neuropsychology from countries in Europe, Australia, and North America based on existing literature, presentations at international conferences, and from description of the training models from national psychological or neuropsychological associations. Despite differences, the reviewed models share similar core competencies considered necessary for a specialty in clinical neuropsychology: (1) In-depth knowledge of general psychology including clinical psychology (post-graduate level), ethical, and legal standards. (2) Expert knowledge about clinically relevant brain-behavioral relationships. (3) Comprehensive knowledge about, and skills in, related clinical disciplines. (4) In-depth knowledge about and skills in neuropsychological assessment, including decision-making and diagnostic competency according to current classification of diseases. (5) Competencies in the area of diversity and culture in relation to clinical neuropsychology. (6) Communication competency of neuropsychological findings and test results to relevant and diverse audiences. (7) Knowledge about and skills in psychological and neuropsychological intervention, including treatment and rehabilitation. All the models have undergone years of development in accordance with requirements of national health care systems in different parts of the world. Despite differences, the common core competency requirements across different regions of the world suggest generalizability of these competencies. We hope this summary can be useful as countries with less established neuropsychology training programs develop their models.

The laboratory diagnosis of bacterial vaginosis

PubMed Central

Money, Deborah

2005-01-01

Bacterial vaginosis (BV) is an extremely common health problem for women. In addition to the troublesome symptoms often associated with a disruption in the balance of vaginal flora, BV is associated with adverse gynecological and pregnancy outcomes. Although not technically a sexually transmitted infection, BV is a sexually associated condition. Diagnostic tests include real-time clinical/microbiological diagnosis, and the current gold standard, the standardized evaluation of morphotypes on Gram stain analysis. The inappropriate use of vaginal culture can be misleading. Future developments into molecular-based diagnostics will be important to further understand this complex endogenous flora disruption. PMID:18159532

Automation and Intensity Modulated Radiation Therapy for Individualized High-Quality Tangent Breast Treatment Plans

DOE Office of Scientific and Technical Information (OSTI.GOV)

Purdie, Thomas G., E-mail: Tom.Purdie@rmp.uhn.on.ca; Department of Radiation Oncology, University of Toronto, Toronto, Ontario; Techna Institute, University Health Network, Toronto, Ontario

Purpose: To demonstrate the large-scale clinical implementation and performance of an automated treatment planning methodology for tangential breast intensity modulated radiation therapy (IMRT). Methods and Materials: Automated planning was used to prospectively plan tangential breast IMRT treatment for 1661 patients between June 2009 and November 2012. The automated planning method emulates the manual steps performed by the user during treatment planning, including anatomical segmentation, beam placement, optimization, dose calculation, and plan documentation. The user specifies clinical requirements of the plan to be generated through a user interface embedded in the planning system. The automated method uses heuristic algorithms to definemore » and simplify the technical aspects of the treatment planning process. Results: Automated planning was used in 1661 of 1708 patients receiving tangential breast IMRT during the time interval studied. Therefore, automated planning was applicable in greater than 97% of cases. The time for treatment planning using the automated process is routinely 5 to 6 minutes on standard commercially available planning hardware. We have shown a consistent reduction in plan rejections from plan reviews through the standard quality control process or weekly quality review multidisciplinary breast rounds as we have automated the planning process for tangential breast IMRT. Clinical plan acceptance increased from 97.3% using our previous semiautomated inverse method to 98.9% using the fully automated method. Conclusions: Automation has become the routine standard method for treatment planning of tangential breast IMRT at our institution and is clinically feasible on a large scale. The method has wide clinical applicability and can add tremendous efficiency, standardization, and quality to the current treatment planning process. The use of automated methods can allow centers to more rapidly adopt IMRT and enhance access to the documented improvements in care for breast cancer patients, using technologies that are widely available and already in clinical use.« less

Optimising the design and operation of semi-continuous affinity chromatography for clinical and commercial manufacture.

PubMed

Pollock, James; Bolton, Glen; Coffman, Jon; Ho, Sa V; Bracewell, Daniel G; Farid, Suzanne S

2013-04-05

This paper presents an integrated experimental and modelling approach to evaluate the potential of semi-continuous chromatography for the capture of monoclonal antibodies (mAb) in clinical and commercial manufacture. Small-scale single-column experimental breakthrough studies were used to derive design equations for the semi-continuous affinity chromatography system. Verification runs with the semi-continuous 3-column and 4-column periodic counter current (PCC) chromatography system indicated the robustness of the design approach. The product quality profiles and step yields (after wash step optimisation) achieved were comparable to the standard batch process. The experimentally-derived design equations were incorporated into a decisional tool comprising dynamic simulation, process economics and sizing optimisation. The decisional tool was used to evaluate the economic and operational feasibility of whole mAb bioprocesses employing PCC affinity capture chromatography versus standard batch chromatography across a product's lifecycle from clinical to commercial manufacture. The tool predicted that PCC capture chromatography would offer more significant savings in direct costs for early-stage clinical manufacture (proof-of-concept) (∼30%) than for late-stage clinical (∼10-15%) or commercial (∼5%) manufacture. The evaluation also highlighted the potential facility fit issues that could arise with a capture resin (MabSelect) that experiences losses in binding capacity when operated in continuous mode over lengthy commercial campaigns. Consequently, the analysis explored the scenario of adopting the PCC system for clinical manufacture and switching to the standard batch process following product launch. The tool determined the PCC system design required to operate at commercial scale without facility fit issues and with similar costs to the standard batch process whilst pursuing a process change application. A retrofitting analysis established that the direct cost savings obtained by 8 proof-of-concept batches would be sufficient to pay back the investment cost of the pilot-scale semi-continuous chromatography system. Copyright © 2013 Elsevier B.V. All rights reserved.

Automation and intensity modulated radiation therapy for individualized high-quality tangent breast treatment plans.

PubMed

Purdie, Thomas G; Dinniwell, Robert E; Fyles, Anthony; Sharpe, Michael B

2014-11-01

To demonstrate the large-scale clinical implementation and performance of an automated treatment planning methodology for tangential breast intensity modulated radiation therapy (IMRT). Automated planning was used to prospectively plan tangential breast IMRT treatment for 1661 patients between June 2009 and November 2012. The automated planning method emulates the manual steps performed by the user during treatment planning, including anatomical segmentation, beam placement, optimization, dose calculation, and plan documentation. The user specifies clinical requirements of the plan to be generated through a user interface embedded in the planning system. The automated method uses heuristic algorithms to define and simplify the technical aspects of the treatment planning process. Automated planning was used in 1661 of 1708 patients receiving tangential breast IMRT during the time interval studied. Therefore, automated planning was applicable in greater than 97% of cases. The time for treatment planning using the automated process is routinely 5 to 6 minutes on standard commercially available planning hardware. We have shown a consistent reduction in plan rejections from plan reviews through the standard quality control process or weekly quality review multidisciplinary breast rounds as we have automated the planning process for tangential breast IMRT. Clinical plan acceptance increased from 97.3% using our previous semiautomated inverse method to 98.9% using the fully automated method. Automation has become the routine standard method for treatment planning of tangential breast IMRT at our institution and is clinically feasible on a large scale. The method has wide clinical applicability and can add tremendous efficiency, standardization, and quality to the current treatment planning process. The use of automated methods can allow centers to more rapidly adopt IMRT and enhance access to the documented improvements in care for breast cancer patients, using technologies that are widely available and already in clinical use. Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical practice guidelines and consensus statements in oncology--an assessment of their methodological quality.

PubMed

Jacobs, Carmel; Graham, Ian D; Makarski, Julie; Chassé, Michaël; Fergusson, Dean; Hutton, Brian; Clemons, Mark

2014-01-01

Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored consistently lower than the others over both domains. No journals adhered to all the items related to the transparency of document development. One journal's consensus statements endorsed a product made by the sponsoring pharmaceutical company in 64% of cases. Guidance documents are an essential part of oncology care and should be subjected to a rigorous and validated development process. Consensus statements had lower methodological quality than clinical practice guidelines using AGREE II. At a minimum, journals should ensure that that all consensus statements and clinical practice guidelines adhere to AGREE II criteria. Journals should consider explicitly requiring guidelines to declare pharmaceutical company sponsorship and to identify the sponsor's product to enhance transparency.

High quality, patient centred and coordinated care for Alstrom syndrome: a model of care for an ultra-rare disease.

PubMed

Van Groenendael, Stephanie; Giacovazzi, Luca; Davison, Fabian; Holtkemper, Oliver; Huang, Zexin; Wang, Qiaoying; Parkinson, Kay; Barrett, Timothy; Geberhiwot, Tarekegn

2015-11-24

Patients with rare and ultra-rare diseases make heavy demands on the resources of both health and social services, but these resources are often used inefficiently due to delays in diagnosis, poor and fragmented care. We analysed the national service for an ultra-rare disease, Alstrom syndrome, and compared the outcome and cost of the service to the standard care. Between the 9th and 26th of March 2014 we undertook a cross-sectional study of the UK Alstrom syndrome patients and their carers. We developed a semi-structured questionnaire to assess our rare patient need, quality of care and costs incurred to patients and their careers. In the UK all Alstrom syndrome patients are seen in two centres, based in Birmingham, and we systematically evaluated the national service and compared the quality and cost of care with patients' previous standard of care. One quarter of genetically confirmed Alstrom syndrome UK patients were enrolled in this study. Patients that have access to a highly specialised clinical service reported that their care is well organised, personalised, holistic, and that they have a say in their care. All patients reported high level of satisfaction in their care. Patient treatment compliance and clinic attendance was better in multidisciplinary clinic than the usual standard of NHS care. Following a variable costing approach based on personnel and consumables' cost, our valuation of the clinics was just under £700/patient/annum compared to the standard care of £960/patient/annum. Real savings, however, came in terms of patients' quality of life. Furthermore there was found to have been a significant reduction in frequency of clinic visits and ordering of investigations since the establishment of the national service. Our study has shown that organised, multidisciplinary "one stop" clinics are patient centred and individually tailored to the patient need with a better outcome and comparable cost compared with the current standard of care for rare disease. Our proposed care model can be adapted to several other rare and ultra-rare diseases.

Current state of prognostication and risk stratification in myelodysplastic syndromes.

PubMed

Zeidan, Amer M; Gore, Steven D; Padron, Eric; Komrokji, Rami S

2015-03-01

Myelodysplastic syndromes (MDS) are characterized by significant biologic and clinical heterogeneity. Because of the wide outcome variability, accurate prognostication is vital to high-quality risk-adaptive care of MDS patients. In this review, we discuss the current state of prognostic schemes for MDS and overview efforts aimed at utilizing molecular aberrations for prognostication in clinical practice. Several prognostic instruments have been developed and validated with increasing accuracy and complexity. Oncologists should be aware of the inherent limitations of these prognostic tools as they counsel patients and make clinical decisions. As more therapies are becoming available for MDS, the focus of model development is shifting from prognostic to treatment-specific predictive instruments. In addition to providing additional prognostic data beyond traditional clinical and pathologic parameters, the improved understanding of the genetic landscape and pathophysiologic consequences in MDS may allow the construction of treatment-specific predictive instruments. How to best use the results of molecular mutation testing to inform clinical decision making in MDS is still a work in progress. Important steps in this direction include standardization in performance and interpretation of assays and better understanding of the independent prognostic importance of the recurrent mutations, especially the less frequent ones.

2017 National Standards for Diabetes Self-Management Education and Support.

PubMed

Beck, Joni; Greenwood, Deborah A; Blanton, Lori; Bollinger, Sandra T; Butcher, Marcene K; Condon, Jo Ellen; Cypress, Marjorie; Faulkner, Priscilla; Fischl, Amy Hess; Francis, Theresa; Kolb, Leslie E; Lavin-Tompkins, Jodi M; MacLeod, Janice; Maryniuk, Melinda; Mensing, Carolé; Orzeck, Eric A; Pope, David D; Pulizzi, Jodi L; Reed, Ardis A; Rhinehart, Andrew S; Siminerio, Linda; Wang, Jing

2018-02-01

Purpose The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends. Methods The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision. Results Diabetes Self-Management Education and Support facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. The evidence indicates that health care providers and people affected by diabetes are embracing technology, and this is having a positive impact of DSMES access, utilization, and outcomes. Conclusion Quality DSMES continues to be a critical element of care for all people with diabetes. The DSMES services must be individualized and guided by the concerns, preferences, and needs of the person affected by diabetes. Even with the abundance of evidence supporting the benefits of DSMES, it continues to be underutilized, but as with other health care services, technology is changing the way DSMES is delivered and utilized with positive outcomes.

2017 National Standards for Diabetes Self-Management Education and Support.

PubMed

Beck, Joni; Greenwood, Deborah A; Blanton, Lori; Bollinger, Sandra T; Butcher, Marcene K; Condon, Jo Ellen; Cypress, Marjorie; Faulkner, Priscilla; Fischl, Amy Hess; Francis, Theresa; Kolb, Leslie E; Lavin-Tompkins, Jodi M; MacLeod, Janice; Maryniuk, Melinda; Mensing, Carolé; Orzeck, Eric A; Pope, David D; Pulizzi, Jodi L; Reed, Ardis A; Rhinehart, Andrew S; Siminerio, Linda; Wang, Jing

2017-10-01

Purpose The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends. Methods The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision. Results Diabetes Self-Management Education and Support facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. The evidence indicates that health care providers and people affected by diabetes are embracing technology, and this is having a positive impact of DSMES access, utilization, and outcomes. Conclusion Quality DSMES continues to be a critical element of care for all people with diabetes. The DSMES services must be individualized and guided by the concerns, preferences, and needs of the person affected by diabetes. Even with the abundance of evidence supporting the benefits of DSMES, it continues to be underutilized, but as with other health care services, technology is changing the way DSMES is delivered and utilized with positive outcomes.

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

PubMed

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

2017-12-24

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

[History of the 4th Department of Internal Medicine of the First Faculty of Medicine at Charles University and the General University Hospital in Prague].

PubMed

Bartůněk, Petr

In 2015, the doctors and nurses of the 4th Department of Internal Medicine of the First Faculty of Medicine, Charles University and the General University Hospital in Prague celebrated the 70th anniversary of its founding. The article summarizes the clinics contribution to the field of internal medicine, and particularly to angiology, hepatogastroenterology and lipidology. It comments the clinics current activities and the possibilities of its further development. Attention is also paid to the tradition of high ethical and professional standards of medical care in accordance with the norms established by the clinic's founder, prof. MUDr. Bohumil Prusík.

Individualized radiotherapy by combining high-end irradiation and magnetic resonance imaging.

PubMed

Combs, Stephanie E; Nüsslin, Fridtjof; Wilkens, Jan J

2016-04-01

Image-guided radiotherapy (IGRT) has been integrated into daily clinical routine and can today be considered the standard especially with high-dose radiotherapy. Currently imaging is based on MV- or kV-CT, which has clear limitations especially in soft-tissue contrast. Thus, combination of magnetic resonance (MR) imaging and high-end radiotherapy opens a new horizon. The intricate technical properties of MR imagers pose a challenge to technology when combined with radiation technology. Several solutions that are almost ready for routine clinical application have been developed. The clinical questions include dose-escalation strategies, monitoring of changes during treatment as well as imaging without additional radiation exposure during treatment.

National turnaround time survey: professional consensus standards for optimal performance and thresholds considered to compromise efficient and effective clinical management.

PubMed

McKillop, Derek J; Auld, Peter

2017-01-01

Background Turnaround time can be defined as the time from receipt of a sample by the laboratory to the validation of the result. The Royal College of Pathologists recommends that a number of performance indicators for turnaround time should be agreed with stakeholders. The difficulty is in arriving at a goal which has some evidence base to support it other than what may simply be currently achievable technically. This survey sought to establish a professional consensus on the goals and meaning of targets for laboratory turnaround time. Methods A questionnaire was circulated by the National Audit Committee to 173 lead consultants for biochemistry in the UK. The survey asked each participant to state their current target turnaround time for core investigations in a broad group of clinical settings. Each participant was also asked to provide a professional opinion on what turnaround time would pose an unacceptable risk to patient safety for each departmental category. A super majority (2/3) was selected as the threshold for consensus. Results The overall response rate was 58% ( n = 100) with a range of 49-72% across the individual Association for Clinical Biochemistry and Laboratory Medicine regions. The consensus optimal turnaround time for the emergency department was <1 h with >2 h considered unacceptable. The times for general practice and outpatient department were <24 h and >48 h and for Wards <4 h and >12 h, respectively. Conclusions We consider that the figures provide a useful benchmark of current opinion, but clearly more empirical standards will have to develop alongside other aspects of healthcare delivery.

Addressing unwarranted clinical variation: A rapid review of current evidence.

PubMed

Harrison, Reema; Manias, Elizabeth; Mears, Stephen; Heslop, David; Hinchcliff, Reece; Hay, Liz

2018-05-15

Unwarranted clinical variation (UCV) can be described as variation that can only be explained by differences in health system performance. There is a lack of clarity regarding how to define and identify UCV and, once identified, to determine whether it is sufficiently problematic to warrant action. As such, the implementation of systemic approaches to reducing UCV is challenging. A review of approaches to understand, identify, and address UCV was undertaken to determine how conceptual and theoretical frameworks currently attempt to define UCV, the approaches used to identify UCV, and the evidence of their effectiveness. Rapid evidence assessment (REA) methodology was used. A range of text words, synonyms, and subject headings were developed for the major concepts of unwarranted clinical variation, standards (and deviation from these standards), and health care environment. Two electronic databases (Medline and Pubmed) were searched from January 2006 to April 2017, in addition to hand searching of relevant journals, reference lists, and grey literature. Results were merged using reference-management software (Endnote) and duplicates removed. Inclusion criteria were independently applied to potentially relevant articles by 3 reviewers. Findings were presented in a narrative synthesis to highlight key concepts addressed in the published literature. A total of 48 relevant publications were included in the review; 21 articles were identified as eligible from the database search, 4 from hand searching published work and 23 from the grey literature. The search process highlighted the voluminous literature reporting clinical variation internationally; yet, there is a dearth of evidence regarding systematic approaches to identifying or addressing UCV. Wennberg's classification framework is commonly cited in relation to classifying variation, but no single approach is agreed upon to systematically explore and address UCV. The instances of UCV that warrant investigation and action are largely determined at a systems level currently, and stakeholder engagement in this process is limited. Lack of consensus on an evidence-based definition for UCV remains a substantial barrier to progress in this field. © 2018 John Wiley & Sons, Ltd.

Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies

PubMed Central

Wang, X; Rivière, I

2015-01-01

Adoptive transfer of tumor-infiltrating lymphocytes (TILs) and genetically engineered T lymphocytes expressing chimeric antigen receptors (CARs) or conventional alpha/beta T-cell receptors (TCRs), collectively termed adoptive cell therapy (ACT), is an emerging novel strategy to treat cancer patients. Application of ACT has been constrained by the ability to isolate and expand functional tumor-reactive T cells. The transition of ACT from a promising experimental regimen to an established standard of care treatment relies largely on the establishment of safe, efficient, robust and cost-effective cell manufacturing protocols. The manufacture of cellular products under current good manufacturing practices (cGMPs) has a critical role in the process. Herein, we review current manufacturing methods for the large-scale production of clinical-grade TILs, virus-specific and genetically modified CAR or TCR transduced T cells in the context of phase I/II clinical trials as well as the regulatory pathway to get these complex personalized cellular products to the clinic. PMID:25721207

Sharing all types of clinical data and harmonizing journal standards.

PubMed

Barbui, Corrado

2016-04-03

Despite recent efforts to enforce policies requiring the sharing of data underlying clinical findings, current policies of biomedical journals remain largely heterogeneous. As this heterogeneity does not optimally serve the cause of data sharing, a first step towards better harmonization would be the requirement of a data sharing statement for all clinical studies and not simply for randomized studies. Although the publication of a data sharing statement does not imply that all data is made readily available, such a policy would swiftly implement a cultural change in the definition of scientific outputs. Currently, a scientific output only corresponds to a study report published in a medical journal, while in the near future it might consist of all materials described in the manuscript, including all relevant raw data. When such a cultural shift has been achieved, the logical conclusion would be for biomedical journals to require authors to make all data fully available without restriction as a condition for publication.

Clinical development of placental malaria vaccines and immunoassays harmonization: a workshop report.

PubMed

Chêne, Arnaud; Houard, Sophie; Nielsen, Morten A; Hundt, Sophia; D'Alessio, Flavia; Sirima, Sodiomon B; Luty, Adrian J F; Duffy, Patrick; Leroy, Odile; Gamain, Benoit; Viebig, Nicola K

2016-09-17

Placental malaria caused by Plasmodium falciparum infection constitutes a major health problem manifesting as severe disease and anaemia in the mother, impaired fetal development, low birth weight or spontaneous abortion. Prevention of placental malaria currently relies on two key strategies that are losing efficacy due to spread of resistance: long-lasting insecticide-treated nets and intermittent preventive treatment during pregnancy. A placental malaria vaccine would be an attractive, cost-effective complement to the existing control tools. Two placental malaria vaccine candidates are currently in Phase Ia/b clinical trials. During two workshops hosted by the European Vaccine Initiative, one in Paris in April 2014 and the other in Brussels in November 2014, the main actors in placental malaria vaccine research discussed the harmonization of clinical development plans and of the immunoassays with a goal to define standards that will allow comparative assessment of different placental malaria vaccine candidates. The recommendations of these workshops should guide researchers and clinicians in the further development of placental malaria vaccines.

Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies.

PubMed

Wang, X; Rivière, I

2015-03-01

Adoptive transfer of tumor-infiltrating lymphocytes (TILs) and genetically engineered T lymphocytes expressing chimeric antigen receptors (CARs) or conventional alpha/beta T-cell receptors (TCRs), collectively termed adoptive cell therapy (ACT), is an emerging novel strategy to treat cancer patients. Application of ACT has been constrained by the ability to isolate and expand functional tumor-reactive T cells. The transition of ACT from a promising experimental regimen to an established standard of care treatment relies largely on the establishment of safe, efficient, robust and cost-effective cell manufacturing protocols. The manufacture of cellular products under current good manufacturing practices (cGMPs) has a critical role in the process. Herein, we review current manufacturing methods for the large-scale production of clinical-grade TILs, virus-specific and genetically modified CAR or TCR transduced T cells in the context of phase I/II clinical trials as well as the regulatory pathway to get these complex personalized cellular products to the clinic.

Integrating DXplain into a clinical information system using the World Wide Web.

PubMed

Elhanan, G; Socratous, S A; Cimino, J J

1996-01-01

The World Wide Web(WWW) offers a cross-platform environment and standard protocols that enable integration of various applications available on the Internet. The authors use the Web to facilitate interaction between their Web-based Clinical Information System and a decision-support system-DXplain, at the Massachusetts General Hospital-using local architecture and Common Gateway Interface programs. The current application translates patients laboratory test results into DXplain's terms to generate diagnostic hypotheses. Two different access methods are utilized for this model; Hypertext Transfer Protocol (HTTP) and TCP/IP function calls. While clinical aspects cannot be evaluated as yet, the model demonstrates the potential of Web-based applications for interaction and integration and how local architecture, with a controlled vocabulary server, can further facilitate such integration. This model serves to demonstrate some of the limitations of the current WWW technology and identifies issues such as control over Web resources and their utilization and liability issues as possible obstacles for further integration.

Protease-activated receptor-1 antagonists in long-term antiplatelet therapy. Current state of evidence and future perspectives.

PubMed

Moschonas, I C; Goudevenos, J A; Tselepis, A D

2015-04-15

Atherothrombosis and its clinical manifestations are among the leading causes of death in the developed world. The current standard-of-care antiplatelet therapy for the treatment of such events comprises aspirin and a thienopyridine or ticagrelor. However, recurrent ischemic events due to residual cardiovascular risk are a common phenomenon in these patients. It is believed that this residual risk is caused, at least in part, by thrombin, which signals through protease-activated receptors (PARs) and especially PAR-1. Thus, PAR-1 antagonism could represent an effective approach in the treatment of atherothrombotic disease. In this context, two potent and selective agents have been developed, vorapaxar and atopaxar. However, only vorapaxar has completed phase 3 clinical trials. In the present review, the main pharmacodynamic and pharmacokinetic properties of the PAR-1 antagonists are briefly described and the latest clinical data on vorapaxar are presented. Copyright © 2015. Published by Elsevier Ireland Ltd.

A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM.

PubMed

Yamamoto, Keiichi; Ota, Keiko; Akiya, Ippei; Shintani, Ayumi

2017-06-01

The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) can be used for new drug application studies as well as secondarily for creating a clinical research data warehouse to leverage clinical research study data across studies conducted within the same disease area. However, currently not all clinical research uses Clinical Data Acquisition Standards Harmonization (CDASH) beginning in the set-up phase of the study. Once already initiated, clinical studies that have not utilized CDASH are difficult to map in the SDTM format. In addition, most electronic data capture (EDC) systems are not equipped to export data in SDTM format; therefore, in many cases, statistical software is used to generate SDTM datasets from accumulated clinical data. In order to facilitate efficient secondary use of accumulated clinical research data using SDTM, it is necessary to develop a new tool to enable mapping of information for SDTM, even during or after the clinical research. REDCap is an EDC system developed by Vanderbilt University and is used globally by over 2100 institutions across 108 countries. In this study, we developed a simulated clinical trial to evaluate a tool called REDCap2SDTM that maps information in the Field Annotation of REDCap to SDTM and executes data conversion, including when data must be pivoted to accommodate the SDTM format, dynamically, by parsing the mapping information using R. We confirmed that generating SDTM data and the define.xml file from REDCap using REDCap2SDTM was possible. Conventionally, generation of SDTM data and the define.xml file from EDC systems requires the creation of individual programs for each clinical study. However, our proposed method can be used to generate this data and file dynamically without programming because it only involves entering the mapping information into the Field Annotation, and additional data into specific files. Our proposed method is adaptable not only to new drug application studies but also to all types of research, including observational and public health studies. Our method is also adaptable to clinical data collected with CDASH at the beginning of a study in non-standard format. We believe that this tool will reduce the workload of new drug application studies and will support data sharing and reuse of clinical research data in academia. Copyright © 2017 Elsevier Inc. All rights reserved.

Personalized health care and health information technology policy: an exploratory analysis.

PubMed

Wald, Jonathan S; Shapiro, Michael

2013-01-01

Personalized healthcare (PHC) is envisioned to enhance clinical practice decision-making using new genome-driven knowledge that tailors diagnosis, treatment, and prevention to the individual patient. In 2012, we conducted a focused environmental scan and informal interviews with fifteen experts to anticipate how PHC might impact health Information Technology (IT) policy in the United States. Findings indicatedthat PHC has a variable impact on current clinical practice, creates complex questions for providers, patients, and policy-makers, and will require a robust health IT infrastructure with advanced data architecture, clinical decision support, provider workflow tools, and re-use of clinical data for research. A number of health IT challenge areas were identified, along with five policy areas including: interoperable clinical decision support, standards for patient values and preferences, patient engagement, data transparency, and robust privacy and security.

A review of the clinical utility of duloxetine in the treatment of diabetic peripheral neuropathic pain

PubMed Central

King, Jordan B; Schauerhamer, Marisa B; Bellows, Brandon K

2015-01-01

Diabetes mellitus is a world-wide epidemic with many long-term complications, with neuropathy being the most common. In particular, diabetic peripheral neuropathic pain (DPNP), can be one of the most distressing complications associated with diabetes, leading to decreases in physical and mental quality of life. Despite the availability of many efficient medications, DPNP remains a challenge to treat, and the optimal sequencing of pharmacotherapy remains unknown. Currently, there are only three medications approved by the US Food and Drug Administration specifically for the management of DPNP. Duloxetine (DUL), a selective serotonin-norepinephrine reuptake inhibitor, is one of these. With the goal of optimizing pharmacotherapy use in DPNP population, a review of current literature was conducted, and the clinical utility of DUL described. Along with early clinical trials, recently published observational studies and pharmacoeconomic models may be useful in guiding decision making by clinicians and managed care organizations. In real-world practice settings, DUL is associated with decreased or similar opioid utilization, increased medication adherence, and similar health care costs compared with current standard of care. DUL has consistently been found to be a cost-effective option over short time-horizons. Currently, the long-term cost-effectiveness of DUL is unknown. Evidence derived from randomized clinical trials, real-world observations, and economic models support the use of DUL as a first-line treatment option from the perspective of the patient, clinician, and managed care payer. PMID:26309404

A review of the clinical utility of duloxetine in the treatment of diabetic peripheral neuropathic pain.

PubMed

King, Jordan B; Schauerhamer, Marisa B; Bellows, Brandon K

2015-01-01

Diabetes mellitus is a world-wide epidemic with many long-term complications, with neuropathy being the most common. In particular, diabetic peripheral neuropathic pain (DPNP), can be one of the most distressing complications associated with diabetes, leading to decreases in physical and mental quality of life. Despite the availability of many efficient medications, DPNP remains a challenge to treat, and the optimal sequencing of pharmacotherapy remains unknown. Currently, there are only three medications approved by the US Food and Drug Administration specifically for the management of DPNP. Duloxetine (DUL), a selective serotonin-norepinephrine reuptake inhibitor, is one of these. With the goal of optimizing pharmacotherapy use in DPNP population, a review of current literature was conducted, and the clinical utility of DUL described. Along with early clinical trials, recently published observational studies and pharmacoeconomic models may be useful in guiding decision making by clinicians and managed care organizations. In real-world practice settings, DUL is associated with decreased or similar opioid utilization, increased medication adherence, and similar health care costs compared with current standard of care. DUL has consistently been found to be a cost-effective option over short time-horizons. Currently, the long-term cost-effectiveness of DUL is unknown. Evidence derived from randomized clinical trials, real-world observations, and economic models support the use of DUL as a first-line treatment option from the perspective of the patient, clinician, and managed care payer.

Cognitive Training and Transcranial Direct Current Stimulation for Mild Cognitive Impairment in Parkinson's Disease: A Randomized Controlled Trial

PubMed Central

Gasson, Natalie; Johnson, Andrew R.; Booth, Leon; Loftus, Andrea M.

2018-01-01

This study examined whether standard cognitive training, tailored cognitive training, transcranial direct current stimulation (tDCS), standard cognitive training + tDCS, or tailored cognitive training + tDCS improved cognitive function and functional outcomes in participants with PD and mild cognitive impairment (PD-MCI). Forty-two participants with PD-MCI were randomized to one of six groups: (1) standard cognitive training, (2) tailored cognitive training, (3) tDCS, (4) standard cognitive training + tDCS, (5) tailored cognitive training + tDCS, or (6) a control group. Interventions lasted 4 weeks, with cognitive and functional outcomes measured at baseline, post-intervention, and follow-up. The trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR: 12614001039673). While controlling for moderator variables, Generalized Linear Mixed Models (GLMMs) showed that when compared to the control group, the intervention groups demonstrated variable statistically significant improvements across executive function, attention/working memory, memory, language, activities of daily living (ADL), and quality of life (QOL; Hedge's g range = 0.01 to 1.75). More outcomes improved for the groups that received standard or tailored cognitive training combined with tDCS. Participants with PD-MCI receiving cognitive training (standard or tailored) or tDCS demonstrated significant improvements on cognitive and functional outcomes, and combining these interventions provided greater therapeutic effects. PMID:29780572

High-intensity therapeutic ultrasound: metrological requirements versus clinical usage

NASA Astrophysics Data System (ADS)

Aubry, J.-F.

2012-10-01

High-intensity therapeutic ultrasound (HITU) is an appealing non-invasive, non-ionizing therapeutic modality with a wide range of tissue interactions ranging from transient permeabilization of cell membranes to thermal ablation. The ability to guide and monitor the treatment with an associated ultrasonic or magnetic resonance imaging device has resulted in a dramatic rise in the clinical use of therapeutic ultrasound in the past two decades. Nevertheless, the range of clinical applications and the number of patients treated has grown at a much higher pace than the definition of standards. In this paper the metrological requirements of the therapeutic beams are reviewed and are compared with the current clinical use of image-guided HITU mostly based on a practical approach. Liver therapy, a particularly challenging clinical application, is discussed to highlight the differences between some complex clinical situations and the experimental conditions of the metrological characterization of ultrasonic transducers.

Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

PubMed

Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

2016-07-06

Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

PubMed Central

2016-01-01

Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

Improving the psychometric properties of dot-probe attention measures using response-based computation.

PubMed

Evans, Travis C; Britton, Jennifer C

2018-09-01

Abnormal threat-related attention in anxiety disorders is most commonly assessed and modified using the dot-probe paradigm; however, poor psychometric properties of reaction-time measures may contribute to inconsistencies across studies. Typically, standard attention measures are derived using average reaction-times obtained in experimentally-defined conditions. However, current approaches based on experimentally-defined conditions are limited. In this study, the psychometric properties of a novel response-based computation approach to analyze dot-probe data are compared to standard measures of attention. 148 adults (19.19 ± 1.42 years, 84 women) completed a standardized dot-probe task including threatening and neutral faces. We generated both standard and response-based measures of attention bias, attentional orientation, and attentional disengagement. We compared overall internal consistency, number of trials necessary to reach internal consistency, test-retest reliability (n = 72), and criterion validity obtained using each approach. Compared to standard attention measures, response-based measures demonstrated uniformly high levels of internal consistency with relatively few trials and varying improvements in test-retest reliability. Additionally, response-based measures demonstrated specific evidence of anxiety-related associations above and beyond both standard attention measures and other confounds. Future studies are necessary to validate this approach in clinical samples. Response-based attention measures demonstrate superior psychometric properties compared to standard attention measures, which may improve the detection of anxiety-related associations and treatment-related changes in clinical samples. Copyright © 2018 Elsevier Ltd. All rights reserved.

Recent Trends in the Serologic Diagnosis of Syphilis

PubMed Central

Singh, Ameeta E.

2014-01-01

Complexities in the diagnosis of syphilis continue to challenge clinicians. While direct tests (e.g., microscopy or PCR) are helpful in early syphilis, the mainstay of diagnosis remains serologic tests. The traditional algorithm using a nontreponemal test (NTT) followed by a treponemal test (TT) remains the standard in many parts of the world. More recently, the ability to automate the TT has led to the increasingly widespread use of reverse algorithms using treponemal enzyme immunoassays (EIAs). Rapid, point-of-care TTs are in widespread use in developing countries because of low cost, ease of use, and reasonable performance. However, none of the current diagnostic algorithms are able to distinguish current from previously treated infections. In addition, the reversal of traditional syphilis algorithms has led to uncertainty in the clinical management of patients. The interpretation of syphilis tests is further complicated by the lack of a reliable gold standard for syphilis diagnostics, and the newer tests can result in false-positive reactions similar to those seen with older tests. Little progress has been made in the area of serologic diagnostics for congenital syphilis, which requires assessment of maternal treatment and serologic response as well as clinical and laboratory investigation of the neonate for appropriate management. The diagnosis of neurosyphilis continues to require the collection of cerebrospinal fluid for a combination of NTT and TT, and, while newer treponemal EIAs look promising, more studies are needed to confirm their utility. This article reviews current tests and discusses current controversies in syphilis diagnosis, with a focus on serologic tests. PMID:25428245

Sedation in gastrointestinal endoscopy: current issues.

PubMed

Triantafillidis, John K; Merikas, Emmanuel; Nikolakis, Dimitrios; Papalois, Apostolos E

2013-01-28

Diagnostic and therapeutic endoscopy can successfully be performed by applying moderate (conscious) sedation. Moderate sedation, using midazolam and an opioid, is the standard method of sedation, although propofol is increasingly being used in many countries because the satisfaction of endoscopists with propofol sedation is greater compared with their satisfaction with conventional sedation. Moreover, the use of propofol is currently preferred for the endoscopic sedation of patients with advanced liver disease due to its short biologic half-life and, consequently, its low risk of inducing hepatic encephalopathy. In the future, propofol could become the preferred sedation agent, especially for routine colonoscopy. Midazolam is the benzodiazepine of choice because of its shorter duration of action and better pharmacokinetic profile compared with diazepam. Among opioids, pethidine and fentanyl are the most popular. A number of other substances have been tested in several clinical trials with promising results. Among them, newer opioids, such as remifentanil, enable a faster recovery. The controversy regarding the administration of sedation by an endoscopist or an experienced nurse, as well as the optimal staffing of endoscopy units, continues to be a matter of discussion. Safe sedation in special clinical circumstances, such as in the cases of obese, pregnant, and elderly individuals, as well as patients with chronic lung, renal or liver disease, requires modification of the dose of the drugs used for sedation. In the great majority of patients, sedation under the supervision of a properly trained endoscopist remains the standard practice worldwide. In this review, an overview of the current knowledge concerning sedation during digestive endoscopy will be provided based on the data in the current literature.

Sedation in gastrointestinal endoscopy: Current issues

PubMed Central

Triantafillidis, John K; Merikas, Emmanuel; Nikolakis, Dimitrios; Papalois, Apostolos E

2013-01-01

Diagnostic and therapeutic endoscopy can successfully be performed by applying moderate (conscious) sedation. Moderate sedation, using midazolam and an opioid, is the standard method of sedation, although propofol is increasingly being used in many countries because the satisfaction of endoscopists with propofol sedation is greater compared with their satisfaction with conventional sedation. Moreover, the use of propofol is currently preferred for the endoscopic sedation of patients with advanced liver disease due to its short biologic half-life and, consequently, its low risk of inducing hepatic encephalopathy. In the future, propofol could become the preferred sedation agent, especially for routine colonoscopy. Midazolam is the benzodiazepine of choice because of its shorter duration of action and better pharmacokinetic profile compared with diazepam. Among opioids, pethidine and fentanyl are the most popular. A number of other substances have been tested in several clinical trials with promising results. Among them, newer opioids, such as remifentanil, enable a faster recovery. The controversy regarding the administration of sedation by an endoscopist or an experienced nurse, as well as the optimal staffing of endoscopy units, continues to be a matter of discussion. Safe sedation in special clinical circumstances, such as in the cases of obese, pregnant, and elderly individuals, as well as patients with chronic lung, renal or liver disease, requires modification of the dose of the drugs used for sedation. In the great majority of patients, sedation under the supervision of a properly trained endoscopist remains the standard practice worldwide. In this review, an overview of the current knowledge concerning sedation during digestive endoscopy will be provided based on the data in the current literature. PMID:23382625

Treatment of lithium intoxication: facing the need for evidence.

PubMed

Haussmann, R; Bauer, M; von Bonin, S; Grof, P; Lewitzka, U

2015-12-01

Lithium has been used as the gold standard in the treatment of major depressive and bipolar disorders for decades. Due to its narrow therapeutic index, lithium toxicity is a common clinical problem. Although risk factors for lithium intoxication seem to be well-described, lacking patient education and inexperience of treatment are assumed to contribute to the probability of lithium intoxication. A review of literature shows that the treatment of lithium intoxication has not been adequately studied or standardized. The aim of this literature review is to compile and present current evidence on the treatment of lithium intoxication and contribute to a standardization regarding general treatment recommendations as well as evidence on indication for extracorporeal methods. Against the background of this common and potentially life-threatening condition, the standardization of the treatment of lithium intoxication is definitely a task for the future.

Utilizing data grid architecture for the backup and recovery of clinical image data.

PubMed

Liu, Brent J; Zhou, M Z; Documet, J

2005-01-01

Grid Computing represents the latest and most exciting technology to evolve from the familiar realm of parallel, peer-to-peer and client-server models. However, there has been limited investigation into the impact of this emerging technology in medical imaging and informatics. In particular, PACS technology, an established clinical image repository system, while having matured significantly during the past ten years, still remains weak in the area of clinical image data backup. Current solutions are expensive or time consuming and the technology is far from foolproof. Many large-scale PACS archive systems still encounter downtime for hours or days, which has the critical effect of crippling daily clinical operations. In this paper, a review of current backup solutions will be presented along with a brief introduction to grid technology. Finally, research and development utilizing the grid architecture for the recovery of clinical image data, in particular, PACS image data, will be presented. The focus of this paper is centered on applying a grid computing architecture to a DICOM environment since DICOM has become the standard for clinical image data and PACS utilizes this standard. A federation of PACS can be created allowing a failed PACS archive to recover its image data from others in the federation in a seamless fashion. The design reflects the five-layer architecture of grid computing: Fabric, Resource, Connectivity, Collective, and Application Layers. The testbed Data Grid is composed of one research laboratory and two clinical sites. The Globus 3.0 Toolkit (Co-developed by the Argonne National Laboratory and Information Sciences Institute, USC) for developing the core and user level middleware is utilized to achieve grid connectivity. The successful implementation and evaluation of utilizing data grid architecture for clinical PACS data backup and recovery will provide an understanding of the methodology for using Data Grid in clinical image data backup for PACS, as well as establishment of benchmarks for performance from future grid technology improvements. In addition, the testbed can serve as a road map for expanded research into large enterprise and federation level data grids to guarantee CA (Continuous Availability, 99.999% up time) in a variety of medical data archiving, retrieval, and distribution scenarios.

Bone disease in multiple myeloma and precursor disease: novel diagnostic approaches and implications on clinical management

PubMed Central

Kristinsson, Sigurdur Y; Minter, Alex R; Korde, Neha; Tan, Esther; Landgren, Ola

2011-01-01

The manifestations of bone involvement in patients with multiple myeloma (MM) can have devastating clinical effects and increase mortality. Recent studies demonstrate that patients with the precursor conditions smoldering MM (SMM) and monoclonal gammopathy of undetermined significance (MGUS) show evidence of bone disease and increased risk of fractures. The understanding of the pathogenesis of bone disease in MM has expanded in recent years. The traditional skeletal survey will probably be replaced by newer and more sensitive imaging techniques, which may have a prognostic impact and change our definition of MGUS and SMM. Bisphosphonates are recommended to prevent skeletal events in patients with MM, and have also been studied in SMM and MGUS. This article summarizes the current knowledge of bone disease in plasma cell disorders, and discusses the current standard and future role of novel imaging techniques, as well as the evidence and current guidelines for bisphosphonates in MM, SMM and MGUS. PMID:21745013

Misophonia: current perspectives

PubMed Central

Cavanna, Andrea E; Seri, Stefano

2015-01-01

Misophonia is characterized by a negative reaction to a sound with a specific pattern and meaning to a given individual. In this paper, we review the clinical features of this relatively common yet underinvestigated condition, with focus on co-occurring neurodevelopmental disorders. Currently available data on the putative pathophysiology of the condition can inform our understanding and guide the diagnostic process and treatment approach. Tinnitus retraining therapy and cognitive behavior therapy have been proposed as the most effective treatment strategies for reducing symptoms; however, current treatment algorithms should be validated in large population studies. At the present stage, competing paradigms see misophonia as a physiological state potentially inducible in any subject, an idiopathic condition (which can present with comorbid psychiatric disorders), or a symptomatic manifestation of an underlying psychiatric disorder. Agreement on the use of standardized diagnostic criteria would be an important step forward in terms of both clinical practice and scientific inquiry. Areas for future research include phenomenology, epidemiology, modulating factors, neurophysiological underpinnings, and treatment trials. PMID:26316758

Misophonia: current perspectives.

PubMed

Cavanna, Andrea E; Seri, Stefano

2015-01-01

Misophonia is characterized by a negative reaction to a sound with a specific pattern and meaning to a given individual. In this paper, we review the clinical features of this relatively common yet underinvestigated condition, with focus on co-occurring neurodevelopmental disorders. Currently available data on the putative pathophysiology of the condition can inform our understanding and guide the diagnostic process and treatment approach. Tinnitus retraining therapy and cognitive behavior therapy have been proposed as the most effective treatment strategies for reducing symptoms; however, current treatment algorithms should be validated in large population studies. At the present stage, competing paradigms see misophonia as a physiological state potentially inducible in any subject, an idiopathic condition (which can present with comorbid psychiatric disorders), or a symptomatic manifestation of an underlying psychiatric disorder. Agreement on the use of standardized diagnostic criteria would be an important step forward in terms of both clinical practice and scientific inquiry. Areas for future research include phenomenology, epidemiology, modulating factors, neurophysiological underpinnings, and treatment trials.

Multivoxel MR Spectroscopy in Acute Ischemic Stroke:Comparison to the Stroke Protocol MRI

PubMed Central

Dani, Krishna A.; An, Li; Henning, Erica C.; Shen, Jun; Warach, Steven

2014-01-01

Background and Purpose Few patients with stroke have been imaged with MR spectroscopy (MRS) within the first few hours after onset. We compared data from current MRI protocols to MRS in subjects with ischemic stroke. Methods MRS was incorporated into the standard clinical MRI stroke protocol for subjects <24 hours after onset. MRI and clinical correlates for the metabolic data from MRS were sought. Results One hundred thirty-six MRS voxels from 32 subjects were analyzed. Lactate preceded the appearance of the lesion on diffusion-weighted imaging in some voxels but in others lagged behind it. Current protocols may predict up to 41% of the variance of MRS metabolites. Serum glucose concentration and time to maximum partially predicted the concentration of all major metabolites. Conclusion MRS may be helpful in acute stroke, especially for lactate detection when perfusion-weighted imaging is unavailable. Current MRI protocols do provide surrogate markers for some indices of metabolic activity. PMID:23091121

Principles of cost effectiveness analysis for the assessment of current and new therapies.

PubMed

Hillner, B E; Smith, T J; Desch, C E

1993-01-01

Economic issues have a prominent place in the debate about reforming the U.S. health care system. If more rational allocations of health care resources are to occur, the principles of decision analysis and clinical economics will need to be understood and used to assess current and new technologies. This requires an explicit assessment of the costs and benefits of a health care intervention, defining the current standard intervention, and clarifying the perspective of the assessment (societal, patient, payer, or provider). Detailed cost accounting of resources is optimal in contrast to costs or charges. These principles were included in 1992 proposed Canadian guidelines for using economic evaluations for adoption of new technologies. Such guidelines provide further impetus for the economic assessment of phase III clinical trials. When applied to peripheral blood progenitor cells, future studies should assess the incremental benefits of the strategy using the progenitor cells, not just the cost savings compared to traditional autologous bone marrow transplantation.

New therapeutic solutions for Behçet's syndrome.

PubMed

Vitale, Antonio; Rigante, Donato; Lopalco, Giuseppe; Emmi, Giacomo; Bianco, Maria Teresa; Galeazzi, Mauro; Iannone, Florenzo; Cantarini, Luca

2016-07-01

Behçet's syndrome (BS) is a systemic inflammatory disorder characterized by a wide range of potential clinical manifestations with no gold-standard therapy. However, the recent classification of BS at a crossroads between autoimmune and autoinflammatory syndromes has paved the way to new further therapeutic opportunities in addition to anti-tumor necrosis factor agents. This review provides a digest of all current experience and evidence about pharmacological agents recently described as having a role in the treatment of BS, including interleukin (IL)-1 inhibitors, tocilizumab, rituximab, alemtuzumab, ustekinumab, interferon-alpha-2a, and apremilast. IL-1 inhibitors currently represent the most studied agents among the latest treatment options for BS, proving to be effective, safe and with an acceptable retention on treatment. However, since BS is a peculiar disorder with clinical features responding to certain treatments that in turn can worsen other manifestations, identifying new treatment options for patients unresponsive to the current drug armamentarium is of great relevance. A number of agents have been studied in the last decade showing changing fortunes in some cases and promising results in others. The latter will potentially provide their contribution for better clinical management of BS, improving patients' quality of life and long-term outcome.

Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data.

PubMed

Moffa, Adriano H; Brunoni, André R; Fregni, Felipe; Palm, Ulrich; Padberg, Frank; Blumberger, Daniel M; Daskalakis, Zafiris J; Bennabi, Djamila; Haffen, Emmanuel; Alonzo, Angelo; Loo, Colleen K

2017-10-15

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation modality that has been increasingly used for major depressive disorder (MDD) treatment. Although studies in healthy volunteers showed that the technique is well-tolerated, tDCS safety and acceptability have not been sufficiently explored in patients with MDD. We collected individual patient data from 6 randomized clinical trials that had been previously identified in a systematic review and meta-analysis. Primary outcomes were safety (rate of adverse events) and acceptability (rate of dropouts). Secondary outcomes were clinical, demographic and treatment predictors of the primary outcomes. Dropout rates between active (8.8%) and sham (12%) groups were not significantly different (OR= 0.7, p=0.38). Adverse event rates between active (73.5%) and sham (68.3%) groups were not significantly different (OR= 1.4, p= 0.23). Higher current densities were associated with lower adverse event rates. Dropout reasons were not systematically reported and adverse events were not collected using questionnaires standardized across studies. Active tDCS is as acceptable and safe as sham tDCS, as found in randomized clinical trials of MDD. Copyright © 2017. Published by Elsevier B.V.

Current Options for Determining Fracture Union

PubMed Central

2014-01-01

Determining whether a bone fracture is healed is one of the most important and fundamental clinical determinations made in orthopaedics. However, there are currently no standardized methods of assessing fracture union, which in turn has created significant disagreement among orthopaedic surgeons in both clinical and research settings. An extensive amount of research has been dedicated to finding novel and reliable ways of determining healing with some promising results. Recent advancements in imaging techniques and introduction of new radiographic scores have helped decrease the amount of disagreement on this topic among physicians. The knowledge gained from biomechanical studies of bone healing has helped us refine our tools and create more efficient and practical research instruments. Additionally, a deeper understanding of the molecular pathways involved in the bone healing process has led to emergence of serologic markers as possible candidates in assessment of fracture union. In addition to our current physician centered methods, patient-centered approaches assessing quality of life and function are gaining popularity in assessment of fracture union. Despite these advances, assessment of union remains an imperfect practice in the clinical setting. Therefore, clinicians need to draw on multiple modalities that directly and indirectly measure or correlate with bone healing when counseling patients. PMID:26556422

In vitro susceptibility of filamentous fungi to itraconazole, voriconazole and posaconazole by Clinical and Laboratory Standards Institute reference method and E-test.

PubMed

Kondori, N; Svensson, E; Mattsby-Baltzer, I

2011-09-01

The use of anti-fungal agents has increased dramatically in recent years and new drugs have been developed. Several methods are available for determinations of their specific biological activities, i.e. the standard method for minimum inhibitory concentration-determination is described in M-38 [Clinical and Laboratory Standards Institute document M-38 (CLSI M-38)]. However, alternative methods, such as the E-test, are currently available in Mycology laboratories. The susceptibilities of clinical isolates of Aspergillus spp. (n = 29), Fusarium spp. (n = 5), zygomycetes (n = 21) and Schizophyllum (n = 1) were determined for itraconazole, voriconazole and posaconazole, using the CLSI M-38-A broth dilution method and also by the E-test. A good overall agreement (83.7%) between the two methods for all drugs and organisms was observed. Analyses of voriconazole showed a better agreement (93%) between the methods than posaconazole and itraconazole (85% and 74% respectively). Aspergillus spp. were the most susceptible fungi to the anti-fungal agents tested in this study. Posaconazole was the most active drug against filamentous fungi in vitro, followed by itraconazole and voriconazole. The latter (voriconazole) demonstrated no significant in vitro activity against zygomycetes. © 2010 Blackwell Verlag GmbH.

Is ginger beneficial for nausea and vomiting? An update of the literature.

PubMed

Marx, Wolfgang; Kiss, Nicole; Isenring, Liz

2015-06-01

Nausea and vomiting can pose a significant burden to patients in a variety of clinical settings. Previous evidence suggests that ginger may be an effective treatment for these symptoms; however, current evidence has been mixed. This article discusses recent clinical trials that have investigated ginger as a treatment for multiple types of nausea and vomiting. In addition, the potential mechanisms of action of ginger will be discussed. This article identified nine studies and seven reviews that investigated ginger for morning sickness, postoperative nausea and vomiting, chemotherapy-induced, and antiretroviral-induced nausea and vomiting. All studies reported that ginger provided a significant reduction in nausea and vomiting; however, the clinical relevance of some studies is less certain. Common limitations within the literature include the lack of standardized extracts, poorly controlled or blinded studies, and limited sample size. In addition, recent evidence has provided further support for 5-HT3 receptor antagonism as a mechanism by which ginger may exert its potentially beneficial effect on nausea and vomiting. The results of studies in this article suggest that ginger is a promising treatment for nausea and vomiting in a variety of clinical settings and possesses a clinically relevant mechanism. However, further studies are required to address the limitations in the current clinical literature before firm recommendations for its use can be made.

Standards for data acquisition and software-based analysis of in vivo electroencephalography recordings from animals. A TASK1-WG5 report of the AES/ILAE Translational Task Force of the ILAE.

PubMed

Moyer, Jason T; Gnatkovsky, Vadym; Ono, Tomonori; Otáhal, Jakub; Wagenaar, Joost; Stacey, William C; Noebels, Jeffrey; Ikeda, Akio; Staley, Kevin; de Curtis, Marco; Litt, Brian; Galanopoulou, Aristea S

2017-11-01

Electroencephalography (EEG)-the direct recording of the electrical activity of populations of neurons-is a tremendously important tool for diagnosing, treating, and researching epilepsy. Although standard procedures for recording and analyzing human EEG exist and are broadly accepted, there are no such standards for research in animal models of seizures and epilepsy-recording montages, acquisition systems, and processing algorithms may differ substantially among investigators and laboratories. The lack of standard procedures for acquiring and analyzing EEG from animal models of epilepsy hinders the interpretation of experimental results and reduces the ability of the scientific community to efficiently translate new experimental findings into clinical practice. Accordingly, the intention of this report is twofold: (1) to review current techniques for the collection and software-based analysis of neural field recordings in animal models of epilepsy, and (2) to offer pertinent standards and reporting guidelines for this research. Specifically, we review current techniques for signal acquisition, signal conditioning, signal processing, data storage, and data sharing, and include applicable recommendations to standardize collection and reporting. We close with a discussion of challenges and future opportunities, and include a supplemental report of currently available acquisition systems and analysis tools. This work represents a collaboration on behalf of the American Epilepsy Society/International League Against Epilepsy (AES/ILAE) Translational Task Force (TASK1-Workgroup 5), and is part of a larger effort to harmonize video-EEG interpretation and analysis methods across studies using in vivo and in vitro seizure and epilepsy models. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

Enhancement of KTP/532 laser disc decompression and arthroscopic microdiscectomy with a vital dye

NASA Astrophysics Data System (ADS)

Yeung, Anthony T.

1993-07-01

Currently, the clinical indications and results of arthroscopic microdiscectomy and laser disc decompression come close to, but do not exceed, the results of classic discectomy or microdiscectomy for the whole spectrum of surgical disc herniations. However, as minimally invasive techniques continue to evolve, results can be expected to equal or be potentially superior to conventional surgery. This exhibit demonstrates how the use of a vital dye can enhance standard arthroscopic microdiscectomy techniques and, when used in conjunction with KTP/532 laser disc decompression, allows for better arthroscopic visualization, documentation, and extraction of nucleus pulposus, ultimately expanding the current limiting criteria for minimally invasive techniques. When proper patient selection is combined with good clinical indications, the surgical results are rather dramatic, often achieving immediate relief of sciatica in the operating room.

[Robot-assisted surgery in the head and neck region].

PubMed

Hoffmann, T K; Friedrich, D T; Schuler, P J

2016-09-01

Robot-assisted surgery (RAS) in the head and neck region is believed to have a large potential for the improvement of patient care. Several systems with a master-slave setup are already in routine clinical use, particularly for oncologic surgery. Although specific patient groups may benefit from RAS, there is a lack of randomized clinical studies validating the advantages of these new technological systems in comparison to the existing standard procedures. On the other hand, RAS in the head and neck region is being constantly developed. Currently, the main limitations are the technical miniaturization of the tools and the loss of haptic feedback, as well as the high costs for acquisition and maintenance without financial reimbursement. In any case, the current generation of head and neck surgeons will face the technical, scientific, and ethical challenges of RAS.

Partial Thickness Rotator Cuff Tears: Current Concepts

PubMed Central

Matthewson, Graeme; Beach, Cara J.; Nelson, Atiba A.; Woodmass, Jarret M.; Ono, Yohei; Boorman, Richard S.; Lo, Ian K. Y.; Thornton, Gail M.

2015-01-01

Partial thickness rotator cuff tears are a common cause of pain in the adult shoulder. Despite their high prevalence, the diagnosis and treatment of partial thickness rotator cuff tears remains controversial. While recent studies have helped to elucidate the anatomy and natural history of disease progression, the optimal treatment, both nonoperative and operative, is unclear. Although the advent of arthroscopy has improved the accuracy of the diagnosis of partial thickness rotator cuff tears, the number of surgical techniques used to repair these tears has also increased. While multiple repair techniques have been described, there is currently no significant clinical evidence supporting more complex surgical techniques over standard rotator cuff repair. Further research is required to determine the clinical indications for surgical and nonsurgical management, when formal rotator cuff repair is specifically indicated and when biologic adjunctive therapy may be utilized. PMID:26171251

Portable recording in the assessment of obstructive sleep apnea. ASDA standards of practice.

PubMed

Ferber, R; Millman, R; Coppola, M; Fleetham, J; Murray, C F; Iber, C; McCall, V; Nino-Murcia, G; Pressman, M; Sanders, M

1994-06-01

The objective assessment of patients with a presumptive diagnosis of obstructive sleep apnea (OSA) has primarily used attended polysomnographic study. Recent technologic advances and issues of availability, convenience and cost have led to a rapid increase in the use of portable recording devices. However, limited scientific information has been published regarding the evaluation of the efficacy, accuracy, validity, utility, cost effectiveness and limitations of this portable equipment. Attaining a clear assessment of the role of portable devices is complicated by the multiplicity of recording systems and the variability of clinical settings in which they have been analyzed. This paper reviews the current knowledge base regarding portable recording in the assessment of OSA, including technical considerations, validation studies, potential advantages and disadvantages, issues of safety, current clinical usage and areas most in need of further study.

Current management of male-to-female gender identity disorder in the UK.

PubMed

Tugnet, Nicola; Goddard, Jonathan Charles; Vickery, Richard M; Khoosal, Deenesh; Terry, Tim R

2007-10-01

Gender identity disorder (GID), or transsexualism as it is more commonly known, is a highly complex clinical entity. Although the exact aetiology of GID is unknown, several environmental, genetic and anatomical theories have been described. The diagnosis of GID can be a difficult process but is established currently using standards of care as defined by the Harry Benjamin International Gender Dysphoria Association. Patients go through extensive psychiatric assessment, including the Real Life Experience, which entails living in the desired gender role 24 h a day for a minimum period of 12 months. The majority of GID patients will eventually go on to have gender realignment surgery, which includes feminising genitoplasty. The clinical features, diagnostic approach and management of male-to-female GID in the UK are reviewed, including the behavioural, psychological and surgical aspects.

Current management of male‐to‐female gender identity disorder in the UK

PubMed Central

Tugnet, Nicola; Goddard, Jonathan Charles; Vickery, Richard M; Khoosal, Deenesh; Terry, Tim R

2007-01-01

Gender identity disorder (GID), or transsexualism as it is more commonly known, is a highly complex clinical entity. Although the exact aetiology of GID is unknown, several environmental, genetic and anatomical theories have been described. The diagnosis of GID can be a difficult process but is established currently using standards of care as defined by the Harry Benjamin International Gender Dysphoria Association. Patients go through extensive psychiatric assessment, including the Real Life Experience, which entails living in the desired gender role 24 h a day for a minimum period of 12 months. The majority of GID patients will eventually go on to have gender realignment surgery, which includes feminising genitoplasty. The clinical features, diagnostic approach and management of male‐to‐female GID in the UK are reviewed, including the behavioural, psychological and surgical aspects. PMID:17916872

Comparative Approaches to Understanding the Relation Between Aging and Physical Function.

PubMed

Justice, Jamie N; Cesari, Matteo; Seals, Douglas R; Shively, Carol A; Carter, Christy S

2016-10-01

Despite dedicated efforts to identify interventions to delay aging, most promising interventions yielding dramatic life-span extension in animal models of aging are often ineffective when translated to clinical trials. This may be due to differences in primary outcomes between species and difficulties in determining the optimal clinical trial paradigms for translation. Measures of physical function, including brief standardized testing batteries, are currently being proposed as biomarkers of aging in humans, are predictive of adverse health events, disability, and mortality, and are commonly used as functional outcomes for clinical trials. Motor outcomes are now being incorporated into preclinical testing, a positive step toward enhancing our ability to translate aging interventions to clinical trials. To further these efforts, we begin a discussion of physical function and disability assessment across species, with special emphasis on mice, rats, monkeys, and man. By understanding how physical function is assessed in humans, we can tailor measurements in animals to better model those outcomes to establish effective, standardized translational functional assessments with aging. © The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Clinical Utility of Viral Load in Management of Cytomegalovirus Infection after Solid Organ Transplantation

PubMed Central

2013-01-01

SUMMARY The negative impact of cytomegalovirus (CMV) infection on transplant outcomes warrants efforts toward improving its prevention, diagnosis, and treatment. During the last 2 decades, significant breakthroughs in diagnostic virology have facilitated remarkable improvements in CMV disease management. During this period, CMV nucleic acid amplification testing (NAT) evolved to become one of the most commonly performed tests in clinical virology laboratories. NAT provides a means for rapid and sensitive diagnosis of CMV infection in transplant recipients. Viral quantification also introduced several principles of CMV disease management. Specifically, viral load has been utilized (i) for prognostication of CMV disease, (ii) to guide preemptive therapy, (iii) to assess the efficacy of antiviral treatment, (iv) to guide the duration of treatment, and (v) to indicate the risk of clinical relapse or antiviral drug resistance. However, there remain important limitations that require further optimization, including the interassay variability in viral load reporting, which has limited the generation of standardized viral load thresholds for various clinical indications. The recent introduction of an international reference standard should advance the major goal of uniform viral load reporting and interpretation. However, it has also become apparent that other aspects of NAT should be standardized, including sample selection, nucleic acid extraction, amplification, detection, and calibration, among others. This review article synthesizes the vast amount of information on CMV NAT and provides a timely review of the clinical utility of viral load testing in the management of CMV in solid organ transplant recipients. Current limitations are highlighted, and avenues for further research are suggested to optimize the clinical application of NAT in the management of CMV after transplantation. PMID:24092851

Molecular markers in bladder cancer: Novel research frontiers.

PubMed

Sanguedolce, Francesca; Cormio, Antonella; Bufo, Pantaleo; Carrieri, Giuseppe; Cormio, Luigi

2015-01-01

Bladder cancer (BC) is a heterogeneous disease encompassing distinct biologic features that lead to extremely different clinical behaviors. In the last 20 years, great efforts have been made to predict disease outcome and response to treatment by developing risk assessment calculators based on multiple standard clinical-pathological factors, as well as by testing several molecular markers. Unfortunately, risk assessment calculators alone fail to accurately assess a single patient's prognosis and response to different treatment options. Several molecular markers easily assessable by routine immunohistochemical techniques hold promise for becoming widely available and cost-effective tools for a more reliable risk assessment, but none have yet entered routine clinical practice. Current research is therefore moving towards (i) identifying novel molecular markers; (ii) testing old and new markers in homogeneous patients' populations receiving homogeneous treatments; (iii) generating a multimarker panel that could be easily, and thus routinely, used in clinical practice; (iv) developing novel risk assessment tools, possibly combining standard clinical-pathological factors with molecular markers. This review analyses the emerging body of literature concerning novel biomarkers, ranging from genetic changes to altered expression of a huge variety of molecules, potentially involved in BC outcome and response to treatment. Findings suggest that some of these indicators, such as serum circulating tumor cells and tissue mitochondrial DNA, seem to be easily assessable and provide reliable information. Other markers, such as the phosphoinositide-3-kinase (PI3K)/AKT (serine-threonine kinase)/mTOR (mammalian target of rapamycin) pathway and epigenetic changes in DNA methylation seem to not only have prognostic/predictive value but also, most importantly, represent valuable therapeutic targets. Finally, there is increasing evidence that the development of novel risk assessment tools combining standard clinical-pathological factors with molecular markers represents a major quest in managing this poorly predictable disease.

An evidence-based approach to assessing surgical versus clinical diagnosis of symptomatic endometriosis.

PubMed

Taylor, Hugh S; Adamson, G David; Diamond, Michael P; Goldstein, Steven R; Horne, Andrew W; Missmer, Stacey A; Snabes, Michael C; Surrey, Eric; Taylor, Robert N

2018-05-05

Challenges intrinsic to the accurate diagnosis of endometriosis contribute to an extended delay between the onset of symptoms and clinical confirmation. Intraoperative visualization, preferably with histologic verification, is considered by many professional organizations to be the gold standard by which endometriosis is diagnosed. Clinical diagnosis of symptomatic endometriosis via patient history, physical examination, and noninvasive tests, though more easily executed, is generally viewed as less accurate than surgical diagnosis. Technological advances and increased understanding of the pathophysiology of endometriosis warrant continuing reevaluation of the standard method for diagnosing symptomatic disease. A review of the published literature was therefore performed with the goal of comparing the accuracy of clinical diagnostic measures with that of surgical diagnosis. The current body of evidence suggests that clinical diagnosis of symptomatic endometriosis is more reliable than previously recognized and that surgical diagnosis has limitations that could be underappreciated. Regardless of the methodology used, women with suspected symptomatic endometriosis would be well served by a diagnostic paradigm that is reliable, conveys minimal risk of under- or over-diagnosis, lessens the time from symptom development to diagnosis, and guides the appropriate use of medical and surgical management strategies. © 2018 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.

Semiautomated Workflow for Clinically Streamlined Glioma Parametric Response Mapping

PubMed Central

Keith, Lauren; Ross, Brian D.; Galbán, Craig J.; Luker, Gary D.; Galbán, Stefanie; Zhao, Binsheng; Guo, Xiaotao; Chenevert, Thomas L.; Hoff, Benjamin A.

2017-01-01

Management of glioblastoma multiforme remains a challenging problem despite recent advances in targeted therapies. Timely assessment of therapeutic agents is hindered by the lack of standard quantitative imaging protocols for determining targeted response. Clinical response assessment for brain tumors is determined by volumetric changes assessed at 10 weeks post-treatment initiation. Further, current clinical criteria fail to use advanced quantitative imaging approaches, such as diffusion and perfusion magnetic resonance imaging. Development of the parametric response mapping (PRM) applied to diffusion-weighted magnetic resonance imaging has provided a sensitive and early biomarker of successful cytotoxic therapy in brain tumors while maintaining a spatial context within the tumor. Although PRM provides an earlier readout than volumetry and sometimes greater sensitivity compared with traditional whole-tumor diffusion statistics, it is not routinely used for patient management; an automated and standardized software for performing the analysis and for the generation of a clinical report document is required for this. We present a semiautomated and seamless workflow for image coregistration, segmentation, and PRM classification of glioblastoma multiforme diffusion-weighted magnetic resonance imaging scans. The software solution can be integrated using local hardware or performed remotely in the cloud while providing connectivity to existing picture archive and communication systems. This is an important step toward implementing PRM analysis of solid tumors in routine clinical practice. PMID:28286871

Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration.

PubMed

Bossuyt, V; Provenzano, E; Symmans, W F; Boughey, J C; Coles, C; Curigliano, G; Dixon, J M; Esserman, L J; Fastner, G; Kuehn, T; Peintinger, F; von Minckwitz, G; White, J; Yang, W; Badve, S; Denkert, C; MacGrogan, G; Penault-Llorca, F; Viale, G; Cameron, D

2015-07-01

Neoadjuvant systemic therapy (NAST) provides the unique opportunity to assess response to treatment after months rather than years of follow-up. However, significant variability exists in methods of pathologic assessment of response to NAST, and thus its interpretation for subsequent clinical decisions. Our international multidisciplinary working group was convened by the Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration and tasked to recommend practical methods for standardized evaluation of the post-NAST surgical breast cancer specimen for clinical trials that promote accurate and reliable designation of pathologic complete response (pCR) and meaningful characterization of residual disease. Recommendations include multidisciplinary communication; clinical marking of the tumor site (clips); and radiologic, photographic, or pictorial imaging of the sliced specimen, to map the tissue sections and reconcile macroscopic and microscopic findings. The information required to define pCR (ypT0/is ypN0 or ypT0 yp N0), residual ypT and ypN stage using the current AJCC/UICC system, and the Residual Cancer Burden system were recommended for quantification of residual disease in clinical trials. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Preparing clinical grade Ag-specific T cells for adoptive immunotherapy trials

PubMed Central

DiGiusto, DL; Cooper, LJN

2007-01-01

The production of clinical-grade T cells for adoptive immunotherapy has evolved from the ex vivo numerical expansion of tumor-infiltrating lymphocytes to sophisticated bioengineering processes often requiring cell selection, genetic modification and other extensive tissue culture manipulations, to produce desired cells with improved therapeutic potential. Advancements in understanding the biology of lymphocyte signaling, activation, homing and sustained in vivo proliferative potential have redefined the strategies used to produce T cells suitable for clinical investigation. When combined with new technical methods in cell processing and culturing, the therapeutic potential of T cells manufactured in academic centers has improved dramatically. Paralleling these technical achievements in cell manufacturing is the development of broadly applied regulatory standards that define the requirements for the clinical implementation of cell products with ever-increasing complexity. In concert with academic facilities operating in compliance with current good manufacturing practice, the prescribing physician can now infuse T cells with a highly selected or endowed phenotype that has been uniformly manufactured according to standard operating procedures and that meets federal guidelines for quality of investigational cell products. In this review we address salient issues related to the technical, immunologic, practical and regulatory aspects of manufacturing these advanced T-cell products for clinical use. PMID:17943498

Relating Standardized Visual Perception Measures to Simulator Visual System Performance

NASA Technical Reports Server (NTRS)

Kaiser, Mary K.; Sweet, Barbara T.

2013-01-01

Human vision is quantified through the use of standardized clinical vision measurements. These measurements typically include visual acuity (near and far), contrast sensitivity, color vision, stereopsis (a.k.a. stereo acuity), and visual field periphery. Simulator visual system performance is specified in terms such as brightness, contrast, color depth, color gamut, gamma, resolution, and field-of-view. How do these simulator performance characteristics relate to the perceptual experience of the pilot in the simulator? In this paper, visual acuity and contrast sensitivity will be related to simulator visual system resolution, contrast, and dynamic range; similarly, color vision will be related to color depth/color gamut. Finally, we will consider how some characteristics of human vision not typically included in current clinical assessments could be used to better inform simulator requirements (e.g., relating dynamic characteristics of human vision to update rate and other temporal display characteristics).

Who are medical marijuana patients? Population characteristics from nine California assessment clinics.

PubMed

Reinarman, Craig; Nunberg, Helen; Lanthier, Fran; Heddleston, Tom

2011-01-01

Marijuana is a currently illegal psychoactive drug that many physicians believe has substantial therapeutic uses. The medical literature contains a growing number of studies on cannabinoids as well as case studies and anecdotal reports suggesting therapeutic potential. Fifteen states have passed medical marijuana laws, but little is known about the growing population of patients who use marijuana medicinally. This article reports on a sample of 1,746 patients from a network of nine medical marijuana evaluation clinics in California. Patients completed a standardized medical history form; evaluating physicians completed standardized evaluation forms. From this data we describe patient characteristics, self-reported presenting symptoms, physician evaluations, other treatments tried, other drug use, and medical marijuana use practices. Pain, insomnia, and anxiety were the most common conditions for which evaluating physicians recommended medical marijuana. Shifts in the medical marijuana patient population over time, the need for further research, and the issue of diversion are discussed.

Patient Summary and medicines reconciliation: application of the ISO/CEN EN 13606 standard in clinical practice.

PubMed

Farfán Sedano, Francisco J; Terrón Cuadrado, Marta; Castellanos Clemente, Yolanda; Serrano Balazote, Pablo; Moner Cano, David; Robles Viejo, Montserrat

2011-01-01

The comparison of the patient's current medication list with the medication being ordered when admitted to Hospital, identifying omissions, duplications, dosing errors, and potential interactions, constitutes the core process of medicines reconciliation. Access to the medication the patient is taking at home could be unfeasible as this information is frequently stored in various locations and in diverse proprietary formats. The lack of interoperability between those information systems, namely the Primary Care and the Specialized Electronic Health Records (EHRs), facilitates medication errors and endangers patient safety. Thus, the development of a Patient Summary that includes clinical data from different electronic systems will allow doctors access to relevant information enabling a safer and more efficient assistance. Such a collection of data from heterogeneous and distributed systems has been achieved in this Project through the construction of a federated view based on the ISO/CEN EN13606 Standard for architecture and communication of EHRs.

Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations.

PubMed

Smith, Shannon M; Jones, Judith K; Katz, Nathaniel P; Roland, Carl L; Setnik, Beatrice; Trudeau, Jeremiah J; Wright, Stephen; Burke, Laurie B; Comer, Sandra D; Dart, Richard C; Dionne, Raymond; Haddox, J David; Jaffe, Jerome H; Kopecky, Ernest A; Martell, Bridget A; Montoya, Ivan D; Stanton, Marsha; Wasan, Ajay D; Turk, Dennis C; Dworkin, Robert H

2017-11-01

Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS). The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of MADDERS as well as SR-MAD. Identifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 published methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation. Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.

Manufacturer evaluations of endograft modifications.

PubMed

Waninger, Matthew S; Whirley, Robert G; Smith, Louis J; Wolf, Ben S

2013-03-01

The motivation to modify the design of a vascular device can arise from a number of sources. Clinical experience with the unmodified device could suggest new design modifications to improve device performance or clinical outcomes. Similarly, clinical success with a device often suggests modifications that could broaden the applicability of the device to enable treatment of different or more advanced disease states. As a specific example, both of these scenarios have arisen during the last decade in the evolution of endovascular grafts for the treatment of abdominal aortic aneurysms, with modifications enabling the treatment of patients with shorter infrarenal necks, more angulated anatomy, and smaller access vessels. These modifications have been made by manufacturers and additionally by physicians who create branched and fenestrated devices. The experience to date with the use of fenestrated devices and the development of chimney, snorkel, and periscope techniques suggests that modifications to off-the-shelf devices may provide some clinical benefit. This experience provides additional motivation for manufacturers to develop devices to address the clinical needs not met with their current product lines. For manufacturers, the device development process includes an assessment of the new device design to determine the appropriate evaluation strategy to support the safety and effectiveness of the modified device. This report provides a high-level overview of the process generally followed by device manufacturers to evaluate a proposed device modification before market release, in accordance with local country regulations and recognized international standards such as the International Organization of Standardization (ISO) standards for endovascular grafts (ISO 25539 Part 1). Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Current therapeutic strategies for premature ejaculation and future perspectives

PubMed Central

Xin, Zhong-Cheng; Zhu, Yi-Chen; Yuan, Yi-Ming; Cui, Wan-Shou; Jin, Zhe; Li, Wei-Ren; Liu, Tao

2011-01-01

Premature ejaculation (PE) is a common sexual disorder in men that is mediated by disturbances in the peripheral and central nervous systems. Although all pharmaceutical treatments for PE are currently used ‘off-label', some novel oral agents and some newer methods of drug administration now provide important relief to PE patients. However, the aetiology of this condition has still not been unified, primarily because of the lack of a standard animal model for basic research and the absence of a widely accepted definition and assessment tool for evidence-based clinical studies in patients with PE. In this review, we focus on the current therapeutic strategies and future treatment perspectives for PE. PMID:21532601

Proposal for a Standard Format for Neurophysiology Data Recording and Exchange.

PubMed

Stead, Matt; Halford, Jonathan J

2016-10-01

The lack of interoperability between information networks is a significant source of cost in health care. Standardized data formats decrease health care cost, improve quality of care, and facilitate biomedical research. There is no common standard digital format for storing clinical neurophysiologic data. This review proposes a new standard file format for neurophysiology data (the bulk of which is video-electroencephalographic data), entitled the Multiscale Electrophysiology Format, version 3 (MEF3), which is designed to address many of the shortcomings of existing formats. MEF3 provides functionality that addresses many of the limitations of current formats. The proposed improvements include (1) hierarchical file structure with improved organization; (2) greater extensibility for big data applications requiring a large number of channels, signal types, and parallel processing; (3) efficient and flexible lossy or lossless data compression; (4) industry standard multilayered data encryption and time obfuscation that permits sharing of human data without the need for deidentification procedures; (5) resistance to file corruption; (6) facilitation of online and offline review and analysis; and (7) provision of full open source documentation. At this time, there is no other neurophysiology format that supports all of these features. MEF3 is currently gaining industry and academic community support. The authors propose the use of the MEF3 as a standard format for neurophysiology recording and data exchange. Collaboration between industry, professional organizations, research communities, and independent standards organizations is needed to move the project forward.

Corridor consultations and the medical microbiological record: is patient safety at risk?

PubMed Central

Heard, S R; Roberts, C; Furrows, S J; Kelsey, M; Southgate, L

2003-01-01

The performance procedures of the General Medical Council are aimed at identifying seriously deficient performance in a doctor. The performance procedures require the medical record to be of a standard that enables the next doctor seeing the patient to give adequate care based on the available information. Setting standards for microbiological record keeping has proved difficult. Over one fifth of practising medical microbiologists (including virologists) in the UK (139 of 676) responded to a survey undertaken by the working group developing the performance procedures for microbiology, to identify current practice and to develop recommendations for agreement within the profession about the standards of the microbiological record. The cumulative frequency for the surveyed recording methods used indicated that at various times 65% (90 of 139) of respondents used a daybook, 62% (86 of 139) used the back of the clinical request card, 57% (79 of 139) used a computer record, and 22% (30 of 139) used an index card system to record microbiological advice, suggesting wide variability in relation to how medical microbiologists maintain clinical records. PMID:12499432

Antianaerobic Antimicrobials: Spectrum and Susceptibility Testing

PubMed Central

Wexler, Hannah M.; Goldstein, Ellie J. C.

2013-01-01

SUMMARY Susceptibility testing of anaerobic bacteria recovered from selected cases can influence the choice of antimicrobial therapy. The Clinical and Laboratory Standards Institute (CLSI) has standardized many laboratory procedures, including anaerobic susceptibility testing (AST), and has published documents for AST. The standardization of testing methods by the CLSI allows comparisons of resistance trends among various laboratories. Susceptibility testing should be performed on organisms recovered from sterile body sites, those that are isolated in pure culture, or those that are clinically important and have variable or unique susceptibility patterns. Organisms that should be considered for individual isolate testing include highly virulent pathogens for which susceptibility cannot be predicted, such as Bacteroides, Prevotella, Fusobacterium, and Clostridium spp.; Bilophila wadsworthia; and Sutterella wadsworthensis. This review describes the current methods for AST in research and reference laboratories. These methods include the use of agar dilution, broth microdilution, Etest, and the spiral gradient endpoint system. The antimicrobials potentially effective against anaerobic bacteria include beta-lactams, combinations of beta-lactams and beta-lactamase inhibitors, metronidazole, chloramphenicol, clindamycin, macrolides, tetracyclines, and fluoroquinolones. The spectrum of efficacy, antimicrobial resistance mechanisms, and resistance patterns against these agents are described. PMID:23824372

An approach for software-driven and standard-based support of cross-enterprise tumor boards.

PubMed

Mangesius, Patrick; Fischer, Bernd; Schabetsberger, Thomas

2015-01-01

For tumor boards, the networking of different medical disciplines' expertise continues to gain importance. However, interdisciplinary tumor boards spread across several institutions are rarely supported by information technology tools today. The aim of this paper is to point out an approach for a tumor board management system prototype. For analyzing the requirements, an incremental process was used. The requirements were surveyed using Informal Conversational Interview and documented with Use Case Diagrams defined by the Unified Modeling Language (UML). Analyses of current EHR standards were conducted to evaluate technical requirements. Functional and technical requirements of clinical conference applications were evaluated and documented. In several steps, workflows were derived and application mockups were created. Although there is a vast amount of common understanding concerning how clinical conferences should be conducted and how their workflows should be structured, these are hardly standardized, neither on a functional nor on a technical level. This results in drawbacks for participants and patients. Using modern EHR technologies based on profiles such as IHE Cross Enterprise document sharing (XDS), these deficits could be overcome.

Standardizing of Pathology in Patients Receiving Neoadjuvant Chemotherapy.

PubMed

Bossuyt, Veerle; Symmans, W Fraser

2016-10-01

The use of neoadjuvant systemic therapy for the treatment of breast cancer patients is increasing. Pathologic response in the form of pathologic complete response (pCR) and grading systems of partial response, such as the residual cancer burden (RCB) system, gives valuable prognostic information for patients and is used as a primary endpoint in clinical trials. The breast cancer and pathology communities are responding with efforts to standardize pathology in patients receiving neoadjuvant chemotherapy. In this review, we summarize the challenges that postneoadjuvant systemic therapy surgical specimens pose and how pathologists and the multidisciplinary team can work together to optimize handling of these specimens. Multidisciplinary communication is essential. A single, standardized approach to macroscopic and microscopic pathologic examination makes it possible to provide reliable response information. This approach employs a map of tissue sections to correlate clinical, gross, microscopic, and imaging findings in order to report the presence of pCR (ypT0 ypN0 and ypT0/is ypN0) versus residual disease, the ypT and ypN stage using the current AJCC/UICC staging system, and the RCB.

Enhancement of CLAIM (clinical accounting information) for a localized Chinese version.

PubMed

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

2005-10-01

CLinical Accounting InforMation (CLAIM) is a standard for the exchange of data between patient accounting systems and electronic medical record (EMR) systems. It uses eXtensible Markup Language (XML) as a meta-language and was developed in Japan. CLAIM is subordinate to the Medical Markup Language (MML) standard, which allows the exchange of medical data between different medical institutions. It has inherited the basic structure of MML 2.x and the current version, version 2.1, contains two modules and nine data definition tables. In China, no data exchange standard yet exists that links EMR systems to accounting systems. Taking advantage of CLAIM's flexibility, we created a localized Chinese version based on CLAIM 2.1. Since Chinese receipt systems differ from those of Japan, some information such as prescription formats, etc. are also different from those in Japan. Two CLAIM modules were re-engineered and six data definition tables were either added or redefined. The Chinese version of CLAIM takes local needs into account, and consequently it is now possible to transfer data between the patient accounting systems and EMR systems of Chinese medical institutions effectively.

Current Status of Bicarbonate in CKD

PubMed Central

Dobre, Mirela; Rahman, Mahboob

2015-01-01

Metabolic acidosis was one of the earliest complications to be recognized and explained pathologically in patients with CKD. Despite the accumulated evidence of deleterious effects of acidosis, treatment of acidosis has been tested very little, especially with respect to standard clinical outcomes. On the basis of fundamental research and small alkali supplementation trials, correcting metabolic acidosis has a strikingly broad array of potential benefits. This review summarizes the published evidence on the association between serum bicarbonate and clinical outcomes. We discuss the role of alkali supplementation in CKD as it relates to retarding kidney disease progression, improving metabolic and musculoskeletal complications. PMID:25150154

76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-24

...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment or prevention of neglected tropical diseases (NTDs), including clinical trial designs and internal review standards to support approval of drugs.

Molecular methods for somatic mutation testing in lung adenocarcinoma: EGFR and beyond

PubMed Central

Rogers, Toni-Maree; Fellowes, Andrew; Bell, Anthony; Fox, Stephen

2015-01-01

Somatic mutational profiling in cancer has revolutionized the practice of clinical oncology. The discovery of driver mutations in non-small cell lung cancer (NSCLC) is an example of this. Molecular testing of lung adenocarcinoma is now considered standard of care and part of the diagnostic algorithm. This article provides an overview of the workflow of molecular testing in a clinical diagnostic laboratory discussing in particular novel assays that are currently in use for somatic mutation detection in NSCLC focussing on epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK), ROS1 and RET rearrangements. PMID:25870795

Commercial Motor Vehicle Driver Obstructive Sleep Apnea Screening and Treatment in the United States: An Update and Recommendation Overview.

PubMed

Colvin, Loretta J; Collop, Nancy A

2016-01-01

No regulatory mandate exists in the United States (U.S.) for comprehensive obstructive sleep apnea (OSA) risk assessment and stratification for commercial motor vehicle (CMV) drivers. Current Federal Motor Carrier Safety Administration (FMCSA) requirements are outdated and depend largely on subjective report, a less reliable strategy in an occupational setting. Without FMCSA standards, sleep specialists, occupational medical examiners and employers rely on a collection of medical consensus recommendations to establish standards of care. These recommendations advise OSA risk assessment through a combination of focused medical history, physical examination, questionnaires, and accident history, which increase OSA detection compared to current FMCSA standards. For those diagnosed with OSA, consensus-based risk stratification helps identify CMV drivers who may benefit from OSA treatment and establish minimum standards for assessing treatment efficacy and adherence. Unfortunately no consolidated recommendation exists; rather, publications span medical and governmental literature in a patchwork fashion that no longer fully reflect current practice due to subsequent advances in OSA diagnosis, treatment, and technology. Based on searches of medical literature, internet materials, and reference lists from existing publications, an overview and discussion of key published recommendations regarding OSA assessment and treatment in CMV operators is provided. Suggestions for incorporating these recommendations into clinical sleep medicine practice in the U.S. are presented. The challenge for sleep specialists is maintaining the delicate balance between recommendations impacting standard of care and associated medico-legal impact with stakeholder interests from medical, regulatory, industry and public perspectives while providing high quality and efficient care. © 2016 American Academy of Sleep Medicine.

Development of the Digital Arthritis Index, a Novel Metric to Measure Disease Parameters in a Rat Model of Rheumatoid Arthritis.

PubMed

Lim, Maria A; Louie, Brenton; Ford, Daniel; Heath, Kyle; Cha, Paulyn; Betts-Lacroix, Joe; Lum, Pek Yee; Robertson, Timothy L; Schaevitz, Laura

2017-01-01

Despite a broad spectrum of anti-arthritic drugs currently on the market, there is a constant demand to develop improved therapeutic agents. Efficient compound screening and rapid evaluation of treatment efficacy in animal models of rheumatoid arthritis (RA) can accelerate the development of clinical candidates. Compound screening by evaluation of disease phenotypes in animal models facilitates preclinical research by enhancing understanding of human pathophysiology; however, there is still a continuous need to improve methods for evaluating disease. Current clinical assessment methods are challenged by the subjective nature of scoring-based methods, time-consuming longitudinal experiments, and the requirement for better functional readouts with relevance to human disease. To address these needs, we developed a low-touch, digital platform for phenotyping preclinical rodent models of disease. As a proof-of-concept, we utilized the rat collagen-induced arthritis (CIA) model of RA and developed the Digital Arthritis Index (DAI), an objective and automated behavioral metric that does not require human-animal interaction during the measurement and calculation of disease parameters. The DAI detected the development of arthritis similar to standard in vivo methods, including ankle joint measurements and arthritis scores, as well as demonstrated a positive correlation to ankle joint histopathology. The DAI also determined responses to multiple standard-of-care (SOC) treatments and nine repurposed compounds predicted by the SMarTR TM Engine to have varying degrees of impact on RA. The disease profiles generated by the DAI complemented those generated by standard methods. The DAI is a highly reproducible and automated approach that can be used in-conjunction with standard methods for detecting RA disease progression and conducting phenotypic drug screens.

Tracking the hyoid bone in videofluoroscopic swallowing studies

NASA Astrophysics Data System (ADS)

Kellen, Patrick M.; Becker, Darci; Reinhardt, Joseph M.; van Daele, Douglas

2008-03-01

Difficulty swallowing, or dysphagia, has become a growing problem. Swallowing complications can lead to malnutrition, dehydration, respiratory infection, and even death. The current gold standard for analyzing and diagnosing dysphagia is the videofluoroscopic barium swallow study. In these studies, a fluoroscope is used to image the patient ingesting barium solutions of different volumes and viscosities. The hyoid bone anchors many key muscles involved in swallowing and plays a key role in the process. Abnormal hyoid bone motion during a swallow can indicate swallowing dysfunction. Currently in clinical settings, hyoid bone motion is assessed qualitatively, which can be subject to intra-rater and inter-rater bias. This paper presents a semi-automatic method for tracking the hyoid bone that makes quantitative analysis feasible. The user defines a template of the hyoid on one frame, and this template is tracked across subsequent frames. The matching phase is optimized by predicting the position of the template based on kinematics. An expert speech pathologist marked the position of the hyoid on each frame of ten studies to serve as the gold standard. Results from performing Bland-Altman analysis at a 95% confidence interval showed a bias of 0.0+/-0.08 pixels in x and -0.08+/-0.09 pixels in y between the manually-defined gold standard and the proposed method. The average Pearson's correlation between the gold standard and the proposed method was 0.987 in x and 0.980 in y. This paper also presents a method for automatically establishing a patient-centric coordinate system for the interpretation of hyoid motion. This coordinate system corrects for upper body patient motion during the study and identifies superior-inferior and anterior-posterior motion components. These tools make the use of quantitative hyoid motion analysis feasible in clinical and research settings.

The Long and Winding Road to Optimal HbA1c Measurement

PubMed Central

Little, Randie R.; Rohlfing, Curt

2016-01-01

The importance of hemoglobin A1c (HbA1c) as an indicator of mean glycemia and risks for complications in patients with diabetes mellitus was established by the results of long-term clinical trials, most notably the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS), published in 1993 and 1998 respectively. However, clinical application of recommended HbA1c targets that were based on these studies was difficult due to lack of comparability of HbA1c results among assay methods and laboratories. Thus, the National Glycohemoglobin Standardization Program (NGSP) was initiated in 1996 with the goal of standardizing HbA1c results to those of the DCCT/UKPDS. HbA1c standardization efforts have been highly successful; however, a number of issues have emerged on the “long and winding road” to better HbA1c, including the development of a higher-order HbA1c reference method by the International Federation of Clinical Chemistry (IFCC), recommendations to use HbA1c to diagnose as well as monitor diabetes, and point-of-care (POC) HbA1c testing. Here, we review the past, present and future of HbA1c standardization and describe the current status of HbA1c testing, including limitations that healthcare providers need to be aware of when interpreting HbA1c results. PMID:23318564

Current efforts in chiropractic quality assurance and standards of care †

PubMed Central

Hansen, Daniel T

1991-01-01

The chiropractic profession has recently begun to proactively address the problems identified by the health care industry. Prompted by rising health care costs, careful analysis revealed that the major culprit was the variance in the delivery of health care. Concerned with outside regulation, health professionals, both in the USA and Canada, are generating clinical guidelines that will serve as templates for the development of standards of care. More specifically, the chiropractic profession is identifying and establishing standards of practice. This in part is due to published data illustrating the variations in treatment frequencies between geographic locations. Acknowledging these variations will enable the identification of solutions. The solutions will be formulated from a growing knowledge base comprised of printed literature and the opinions of recognized experts through consensus panels. The result is the creation of practice standards and guidelines that will serve to answer concerns of accountability and ultimately to protect the public. The process from the creation to the implementation of the guidelines is necessarily detailed; but can be enhanced by the use of clinical algorithms. Clinical algorithms describe a step wise procedure to patient management that may impact upon patient care, health care costs and outcome measures. As chiropractic achieves greater visibility, it will be expected to perform at the same level of accountability as the other health provider groups. Each chiropractor should understand the process and its limitations, and be prepared to contribute in the development, distribution and implementation of reasonable practice guidelines.

Independent Validation and Clinical Utility Study of the Hellenic WISC-III Using a Greek-Cypriot Sample

ERIC Educational Resources Information Center

Souroulla, Andry Vrachimi; Panayiotou, Georgia

2017-01-01

The Hellenic WISC-III (Wechsler, 1997) is currently the only standardized and officially published tool for the assessment of the intelligence of children and adolescents in Greece. The test is also used with caution in Cyprus, among Greek speakers, but no specific norms exist for use in this country. The purpose of this study was to provide…

A framework for automatic creation of gold-standard rigid 3D-2D registration datasets.

PubMed

Madan, Hennadii; Pernuš, Franjo; Likar, Boštjan; Špiclin, Žiga

2017-02-01

Advanced image-guided medical procedures incorporate 2D intra-interventional information into pre-interventional 3D image and plan of the procedure through 3D/2D image registration (32R). To enter clinical use, and even for publication purposes, novel and existing 32R methods have to be rigorously validated. The performance of a 32R method can be estimated by comparing it to an accurate reference or gold standard method (usually based on fiducial markers) on the same set of images (gold standard dataset). Objective validation and comparison of methods are possible only if evaluation methodology is standardized, and the gold standard  dataset is made publicly available. Currently, very few such datasets exist and only one contains images of multiple patients acquired during a procedure. To encourage the creation of gold standard 32R datasets, we propose an automatic framework. The framework is based on rigid registration of fiducial markers. The main novelty is spatial grouping of fiducial markers on the carrier device, which enables automatic marker localization and identification across the 3D and 2D images. The proposed framework was demonstrated on clinical angiograms of 20 patients. Rigid 32R computed by the framework was more accurate than that obtained manually, with the respective target registration error below 0.027 mm compared to 0.040 mm. The framework is applicable for gold standard setup on any rigid anatomy, provided that the acquired images contain spatially grouped fiducial markers. The gold standard datasets and software will be made publicly available.

Capturing Essential Information to Achieve Safe Interoperability

PubMed Central

Weininger, Sandy; Jaffe, Michael B.; Rausch, Tracy; Goldman, Julian M.

2016-01-01

In this article we describe the role of “clinical scenario” information to assure the safety of interoperable systems, as well as the system’s ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets (MDIDSa) and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a “Patient-controlled analgesia safety interlock” are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a Learning Health System to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™, is described. PMID:27387840

Capturing Essential Information to Achieve Safe Interoperability.

PubMed

Weininger, Sandy; Jaffe, Michael B; Rausch, Tracy; Goldman, Julian M

2017-01-01

In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a "patient-controlled analgesia safety interlock" are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a learning health system to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A Web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™ (MD PnP Program), is described.

Exceptions to the rule: case studies in the prediction of pathogenicity for genetic variants in hereditary cancer genes.

PubMed

Rosenthal, E T; Bowles, K R; Pruss, D; van Kan, A; Vail, P J; McElroy, H; Wenstrup, R J

2015-12-01

Based on current consensus guidelines and standard practice, many genetic variants detected in clinical testing are classified as disease causing based on their predicted impact on the normal expression or function of the gene in the absence of additional data. However, our laboratory has identified a subset of such variants in hereditary cancer genes for which compelling contradictory evidence emerged after the initial evaluation following the first observation of the variant. Three representative examples of variants in BRCA1, BRCA2 and MSH2 that are predicted to disrupt splicing, prematurely truncate the protein, or remove the start codon were evaluated for pathogenicity by analyzing clinical data with multiple classification algorithms. Available clinical data for all three variants contradicts the expected pathogenic classification. These variants illustrate potential pitfalls associated with standard approaches to variant classification as well as the challenges associated with monitoring data, updating classifications, and reporting potentially contradictory interpretations to the clinicians responsible for translating test outcomes to appropriate clinical action. It is important to address these challenges now as the model for clinical testing moves toward the use of large multi-gene panels and whole exome/genome analysis, which will dramatically increase the number of genetic variants identified. © 2015 The Authors. Clinical Genetics published by John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations.

PubMed

Smith, Shannon M; Dworkin, Robert H; Turk, Dennis C; Baron, Ralf; Polydefkis, Michael; Tracey, Irene; Borsook, David; Edwards, Robert R; Harris, Richard E; Wager, Tor D; Arendt-Nielsen, Lars; Burke, Laurie B; Carr, Daniel B; Chappell, Amy; Farrar, John T; Freeman, Roy; Gilron, Ian; Goli, Veeraindar; Haeussler, Juergen; Jensen, Troels; Katz, Nathaniel P; Kent, Jeffrey; Kopecky, Ernest A; Lee, David A; Maixner, William; Markman, John D; McArthur, Justin C; McDermott, Michael P; Parvathenani, Lav; Raja, Srinivasa N; Rappaport, Bob A; Rice, Andrew S C; Rowbotham, Michael C; Tobias, Jeffrey K; Wasan, Ajay D; Witter, James

2017-07-01

Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment response. Currently, there are no biomarkers for pain qualified by the U.S. Food and Drug Administration or the European Medicines Agency for use in clinical trials. This article summarizes an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting in which 3 potential biomarkers were discussed for use in the development of analgesic treatments: 1) sensory testing, 2) skin punch biopsy, and 3) brain imaging. The empirical evidence supporting the use of these tests is described within the context of the 4 categories of biomarkers: 1) diagnostic, 2) prognostic, 3) predictive, and 4) pharmacodynamic. Although sensory testing, skin punch biopsy, and brain imaging are promising tools for pain in clinical trials, additional evidence is needed to further support and standardize these tests for use as biomarkers in pain clinical trials. The applicability of sensory testing, skin biopsy, and brain imaging as diagnostic, prognostic, predictive, and pharmacodynamic biomarkers for use in analgesic treatment trials is considered. Evidence in support of their use and outlining problems is presented, as well as a call for further standardization and demonstrations of validity and reliability. Copyright © 2017 American Pain Society. All rights reserved.

Is Dysfunctional Use of the Mobile Phone a Behavioural Addiction? Confronting Symptom-Based Versus Process-Based Approaches.

PubMed

Billieux, Joël; Philippot, Pierre; Schmid, Cécile; Maurage, Pierre; De Mol, Jan; Van der Linden, Martial

2015-01-01

Dysfunctional use of the mobile phone has often been conceptualized as a 'behavioural addiction' that shares most features with drug addictions. In the current article, we challenge the clinical utility of the addiction model as applied to mobile phone overuse. We describe the case of a woman who overuses her mobile phone from two distinct approaches: (1) a symptom-based categorical approach inspired from the addiction model of dysfunctional mobile phone use and (2) a process-based approach resulting from an idiosyncratic clinical case conceptualization. In the case depicted here, the addiction model was shown to lead to standardized and non-relevant treatment, whereas the clinical case conceptualization allowed identification of specific psychological processes that can be targeted with specific, empirically based psychological interventions. This finding highlights that conceptualizing excessive behaviours (e.g., gambling and sex) within the addiction model can be a simplification of an individual's psychological functioning, offering only limited clinical relevance. The addiction model, applied to excessive behaviours (e.g., gambling, sex and Internet-related activities) may lead to non-relevant standardized treatments. Clinical case conceptualization allowed identification of specific psychological processes that can be targeted with specific empirically based psychological interventions. The biomedical model might lead to the simplification of an individual's psychological functioning with limited clinical relevance. Copyright © 2014 John Wiley & Sons, Ltd.

Orthopaedic regenerative tissue engineering en route to the holy grail: disequilibrium between the demand and the supply in the operating room.

PubMed

Cengiz, Ibrahim Fatih; Pereira, Hélder; de Girolamo, Laura; Cucchiarini, Magali; Espregueira-Mendes, João; Reis, Rui L; Oliveira, Joaquim Miguel

2018-05-22

Orthopaedic disorders are very frequent, globally found and often partially unresolved despite the substantial advances in science and medicine. Their surgical intervention is multifarious and the most favourable treatment is chosen by the orthopaedic surgeon on a case-by-case basis depending on a number of factors related with the patient and the lesion. Numerous regenerative tissue engineering strategies have been developed and studied extensively in laboratory through in vitro experiments and preclinical in vivo trials with various established animal models, while a small proportion of them reached the operating room. However, based on the available literature, the current strategies have not yet achieved to fully solve the clinical problems. Thus, the gold standards, if existing, remain unchanged in the clinics, notwithstanding the known limitations and drawbacks. Herein, the involvement of regenerative tissue engineering in the clinical orthopaedics is reviewed. The current challenges are indicated and discussed in order to describe the current disequilibrium between the needs and solutions made available in the operating room. Regenerative tissue engineering is a very dynamic field that has a high growth rate and a great openness and ability to incorporate new technologies with passion to edge towards the Holy Grail that is functional tissue regeneration. Thus, the future of clinical solutions making use of regenerative tissue engineering principles for the management of orthopaedic disorders is firmly supported by the clinical need.

The effect of cone beam CT (CBCT) on therapeutic decision-making in endodontics

PubMed Central

Knutsson, K; Flygare, L

2014-01-01

Objectives: The aim was to assess to what extent cone beam CT (CBCT) used in accordance with current European Commission guidelines in a normal clinical setting has an impact on therapeutic decisions in a population referred for endodontic problems. Methods: The study includes data of consecutively examined patients collected from October 2011 to December 2012. From 2 different endodontic specialist clinics, 57 patients were referred for a CBCT examination using criteria in accordance with current European guidelines. The CBCT examinations were performed using similar equipment and standardized among clinics. After a thorough clinical examination, but before CBCT, the examiner made a preliminary therapy plan which was recorded. After the CBCT examination, the same examiner made a new therapy plan. Therapy plans both before and after the CBCT examination were plotted for 53 patients and 81 teeth. As four patients had incomplete protocols, they were not included in the final analysis. Results: 4% of the patients referred to endodontic clinics during the study period were examined with CBCT. The most frequent reason for referral to CBCT examination was to differentiate pathology from normal anatomy, this was the case in 24 patients (45% of the cases). The primary outcome was therapy plan changes that could be attributed to CBCT examination. There were changes in 28 patients (53%). Conclusions: CBCT has a significant impact on therapeutic decision efficacy in endodontics when used in concordance with the current European Commission guidelines. PMID:24766060

Concise Review: The Clinical Application of Mesenchymal Stem Cells for Musculoskeletal Regeneration: Current Status and Perspectives

PubMed Central

Steinert, Andre F.; Rackwitz, Lars; Gilbert, Fabian; Nöth, Ulrich

2012-01-01

Regenerative therapies in the musculoskeletal system are based on the suitable application of cells, biomaterials, and/or factors. For an effective approach, numerous aspects have to be taken into consideration, including age, disease, target tissue, and several environmental factors. Significant research efforts have been undertaken in the last decade to develop specific cell-based therapies, and in particular adult multipotent mesenchymal stem cells hold great promise for such regenerative strategies. Clinical translation of such therapies, however, remains a work in progress. In the clinical arena, autologous cells have been harvested, processed, and readministered according to protocols distinct for the target application. As outlined in this review, such applications range from simple single-step approaches, such as direct injection of unprocessed or concentrated blood or bone marrow aspirates, to fabrication of engineered constructs by seeding of natural or synthetic scaffolds with cells, which were released from autologous tissues and propagated under good manufacturing practice conditions (for example, autologous chondrocyte implantation). However, only relatively few of these cell-based approaches have entered the clinic, and none of these treatments has become a “standard of care” treatment for an orthopaedic disease to date. The multifaceted reasons for the current status from the medical, research, and regulatory perspectives are discussed here. In summary, this review presents the scientific background, current state, and implications of clinical mesenchymal stem cell application in the musculoskeletal system and provides perspectives for future developments. PMID:23197783

Do the ends justify the means? Nursing and the dilemma of whistleblowing.

PubMed

Firtko, Angela; Jackson, Debra

2005-01-01

Patient advocacy and a desire to rectify misconduct in the clinical setting are frequently cited reasons for whistleblowing in nursing and healthcare. This paper explores current knowledge about whistleblowing in nursing and critiques current definitions of whistleblowing. The authors draw on published perspectives of whistleblowing including the media, to reflect on the role of the media in health related whistleblowing. Whistleblowing represents a dilemma for nurses. It strikes at the heart of professional values and raises questions about the responsibilities nurses have to communities and clients, the profession, and themselves. In its most damaging forms, whistleblowing necessarily involves a breach of ethical standards, particularly confidentiality. Despite the pain that can be associated with whistleblowing, if the ends are improved professional standards, enhanced outcomes, rectification of wrongdoings, and, increased safety for patients and staff in our health services, then the ends definitely justify the means.

Robotic surgical systems in maxillofacial surgery: a review

PubMed Central

Liu, Hang-Hang; Li, Long-Jiang; Shi, Bin; Xu, Chun-Wei; Luo, En

2017-01-01

Throughout the twenty-first century, robotic surgery has been used in multiple oral surgical procedures for the treatment of head and neck tumors and non-malignant diseases. With the assistance of robotic surgical systems, maxillofacial surgery is performed with less blood loss, fewer complications, shorter hospitalization and better cosmetic results than standard open surgery. However, the application of robotic surgery techniques to the treatment of head and neck diseases remains in an experimental stage, and the long-lasting effects on surgical morbidity, oncologic control and quality of life are yet to be established. More well-designed studies are needed before this approach can be recommended as a standard treatment paradigm. Nonetheless, robotic surgical systems will inevitably be extended to maxillofacial surgery. This article reviews the current clinical applications of robotic surgery in the head and neck region and highlights the benefits and limitations of current robotic surgical systems. PMID:28660906

Dysglycemias in pregnancy: from diagnosis to treatment. Brazilian consensus statement

PubMed Central

2010-01-01

There is an urgent need to find consensus on screening, diagnosing and treating all degrees of DYSGLYCEMIA that may occur during pregnancies in Brazil, considering that many cases of DYSGLYCEMIA in pregnant women are currently not diagnosed, leading to maternal and fetal complications. For this reason the Brazilian Diabetes Society (SBD) and the Brazilian Federation of Gynecology and Obstetrics Societies (FEBRASGO), got together to introduce this proposal. We present here a joint consensus regarding the standardization of clinical management for pregnant women with any degree of Dysglycemia, on the basis of current information, to improve medical assistance and to avoid related complications of Dysglycemia in pregnancy to the mother and the fetus. This consensus aims to standardize the diagnosis among general practitioners, endocrinologists and obstetricians allowing the dissemination of information in basic health units, public and private services, that are responsible for screening, diagnosing and treating disglycemic pregnant patients. PMID:20416099