WorldWideScience

Sample records for clinic researchers discover

  1. [The research of basic medical education with clinical practice and culturing of discovering and creative ability for students].

    Science.gov (United States)

    Yang, Kang-Juan; Jin, Ying-Zi; Zhang, Zi-Bo; Jin, Yan-Hua; Jin, Xiong-Ji; Xiu, Jing-Hui; Sun, Lian-Ping; Liu, Yang; Sheng, Tian-Xin

    2008-05-01

    In order to explore the educational model of combined research aidding basic medical education and clinical practice, the educational form of combined research, teaching and clinical practice was adopted and brought into the education of medical genetics for medical students. The consequence of five-year educational practice has revealed that the educational effects and quality have been obviously increased, and the deeply activated studying initiative, self-studying ability, ability of cooperation, discovering and creative ability have been achieved in culturing practical general medical students with in-depth basic knowledge, great ability and high quality.

  2. Research concerning intestinal parasitosis in infant population discovered in two clinic laboratories from Oradea (Romania

    Directory of Open Access Journals (Sweden)

    Daniel-Dumitru PORTELECHI

    2006-05-01

    Full Text Available Considering the research made and the data offered by the specialists in parasitology from Oradea’s no.1 Polyclinic and Children’s Hospital, we have established that children from 1 to 18 years old have been found infected with 7 species of human parasites. Giardia lamblia, Blastocystis hominis, Ascaris lumbricoides, Oxyurus vermicularis, Trichurus trichiura, Hymenolepis nana, Hymenolepis diminuta.

  3. Discover POPSCIENCE on Researchers' Night

    CERN Multimedia

    The POPSCIENCE Team

    2014-01-01

    On Friday 26 September 2014, CERN will be celebrating European Researchers' Night at three venues in Geneva and St. Genis-Pouilly. Inspired by Andy Warhol, this year's theme is “Pop science is for everyone”.     Every year, on the last Friday of September, the European Researchers’ Night takes place in about 300 cities all over Europe, with funding from the EU, to promote research and highlight researchers in engaging and fun ways for the general public. Andy Warhol said, “Pop art is for everyone”. This year, “Pop science is for everyone” is the motto of the Researchers’ Night event organised by CERN and its partners*. The night will offer everyone the opportunity to learn about the latest discoveries in physics and cosmology through poetry, theatre and music. This will be in addition to the event's traditional activities for the general public. To attract new audiences,...

  4. Discovering Related Clinical Concepts Using Large Amounts of Clinical Notes.

    Science.gov (United States)

    Ganesan, Kavita; Lloyd, Shane; Sarkar, Vikren

    2016-01-01

    The ability to find highly related clinical concepts is essential for many applications such as for hypothesis generation, query expansion for medical literature search, search results filtering, ICD-10 code filtering and many other applications. While manually constructed medical terminologies such as SNOMED CT can surface certain related concepts, these terminologies are inadequate as they depend on expertise of several subject matter experts making the terminology curation process open to geographic and language bias. In addition, these terminologies also provide no quantifiable evidence on how related the concepts are. In this work, we explore an unsupervised graphical approach to mine related concepts by leveraging the volume within large amounts of clinical notes. Our evaluation shows that we are able to use a data driven approach to discovering highly related concepts for various search terms including medications, symptoms and diseases.

  5. Discovering Related Clinical Concepts Using Large Amounts of Clinical Notes

    Directory of Open Access Journals (Sweden)

    Kavita Ganesan

    2016-01-01

    Full Text Available The ability to find highly related clinical concepts is essential for many applications such as for hypothesis generation, query expansion for medical literature search, search results filtering, ICD-10 code filtering and many other applications. While manually constructed medical terminologies such as SNOMED CT can surface certain related concepts, these terminologies are inadequate as they depend on expertise of several subject matter experts making the terminology curation process open to geographic and language bias. In addition, these terminologies also provide no quantifiable evidence on how related the concepts are. In this work, we explore an unsupervised graphical approach to mine related concepts by leveraging the volume within large amounts of clinical notes. Our evaluation shows that we are able to use a data driven approach to discovering highly related concepts for various search terms including medications, symptoms and diseases.

  6. 2015 USAFA Research Report: Discover Falcon Innovation

    Science.gov (United States)

    2015-01-01

    corrosion, wear, or other forms of material degradation that could impact the structure’s design capability. CAStLE in fact authored the USAF standards...altitude countries like Afghanistan, Zupan said. The HPL uses cadets involved in athletes in its research projects, helping boxers, basketball ...gives us a combat edge.’” Portions of this research thread are currently being conducted at the Academy’s indoor simulated shooting range. More

  7. Clinical Research

    DEFF Research Database (Denmark)

    Christensen, Irene

    2016-01-01

    This paper is about the logic of problem solving and the production of scientific knowledge through the utilisation of clinical research perspective. Ramp-up effectiveness, productivity, efficiency and organizational excellence are topics that continue to engage research and will continue doing so...... for years to come. This paper seeks to provide insights into ramp-up management studies through providing an agenda for conducting collaborative clinical research and extend this area by proposing how clinical research could be designed and executed in the Ramp- up management setting....

  8. Incorporating Topic Assignment Constraint and Topic Correlation Limitation into Clinical Goal Discovering for Clinical Pathway Mining

    Directory of Open Access Journals (Sweden)

    Xiao Xu

    2017-01-01

    Full Text Available Clinical pathways are widely used around the world for providing quality medical treatment and controlling healthcare cost. However, the expert-designed clinical pathways can hardly deal with the variances among hospitals and patients. It calls for more dynamic and adaptive process, which is derived from various clinical data. Topic-based clinical pathway mining is an effective approach to discover a concise process model. Through this approach, the latent topics found by latent Dirichlet allocation (LDA represent the clinical goals. And process mining methods are used to extract the temporal relations between these topics. However, the topic quality is usually not desirable due to the low performance of the LDA in clinical data. In this paper, we incorporate topic assignment constraint and topic correlation limitation into the LDA to enhance the ability of discovering high-quality topics. Two real-world datasets are used to evaluate the proposed method. The results show that the topics discovered by our method are with higher coherence, informativeness, and coverage than the original LDA. These quality topics are suitable to represent the clinical goals. Also, we illustrate that our method is effective in generating a comprehensive topic-based clinical pathway model.

  9. Lipids in newly discovered subclinical and clinical hypothyroidism

    Directory of Open Access Journals (Sweden)

    Marinković Snežana

    2016-01-01

    Full Text Available There is a positive correlation between the levels of TSH and cholesterol levels, while levels between TSH levels triglicrerida negative correlation with the clinical and subclinical form of reduced thyroid function.

  10. Strategies for teaching nursing research. Discovering the creative listening hole.

    Science.gov (United States)

    Sarosi, G M; Taylor, J J

    1994-04-01

    Creative questioning that is based on nonverbal inner listening can lead to new insights, discoveries, and perspectives. Though very challenging, the mythology of reaching the listening hole can help the student develop an ear for keys or gaps in his or her perceptions about phenomena. It can help develop respect for the rich lode of nursing experience from which researchable questions can be developed. Finally, creative research questioning introduces a new mental discipline that can lead to a fresh perception of nursing practice questions. The value of the process outweighs the risks and difficulties.

  11. Proteomics research to discover markers: what can we learn from Netflix?

    Science.gov (United States)

    Ransohoff, David F

    2010-02-01

    Research in the field of proteomics to discover markers for detection of cancer has produced disappointing results, with few markers gaining US Food and Drug Administration approval, and few claims borne out when subsequently tested in rigorous studies. What is the role of better mathematical or statistical analysis in improving the situation? This article examines whether a recent successful Netflix-sponsored competition using mathematical analysis to develop a prediction model for movie ratings of individual subscribers can serve to improve studies of markers in the field of proteomics. Netflix developed a database of movie preferences of individual subscribers using a longitudinal cohort research design. Groups of researchers then competed to develop better ways to analyze the data. Against this background, the strengths and weaknesses of research design are reviewed, contrasting the Netflix design with that of studies of biomarkers to detect cancer. Such biomarker studies generally have less-strong design, lower numbers of outcomes, and greater difficulty in even just measuring predictors and outcomes, so the fundamental data that will be used in mathematical analysis tend to be much weaker than in other kinds of research. If the fundamental data that will be analyzed are not strong, then better analytic methods have limited use in improving the situation. Recognition of this situation is an important first step toward improving the quality of clinical research about markers to detect cancer.

  12. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  13. Clinical research informatics

    CERN Document Server

    Richesson, Rachel L

    2012-01-01

    This book provides foundational coverage of key areas, concepts, constructs, and approaches of medical informatics as it applies to clinical research activities, in both current settings and in light of emerging policies. The field of clinical research is fully characterized (in terms of study design and overarching business processes), and there is emphasis on information management aspects and informatics implications (including needed activities) within various clinical research environments. The purpose of the book is to provide an overview of clinical research (types), activities, and are

  14. Discovering Inexpensive, Effective Catalysts for Solar Energy Conversion: An Authentic Research Laboratory Experience

    Science.gov (United States)

    Shaner, Sarah E.; Hooker, Paul D.; Nickel, Anne-Marie; Leichtfuss, Amanda R.; Adams, Carissa S.; de la Cerda, Dionisia; She, Yuqi; Gerken, James B.; Pokhrel, Ravi; Ambrose, Nicholas J.; Khaliqi, David; Stahl, Shannon S.; Schuttlefield Christus, Jennifer D.

    2016-01-01

    Electrochemical water oxidation is a major focus of solar energy conversion efforts. A new laboratory experiment has been developed that utilizes real-time, hands-on research to discover catalysts for solar energy conversion. The HARPOON, or Heterogeneous Anodes Rapidly Perused for Oxygen Overpotential Neutralization, experiment allows an array of…

  15. Clinical impact of renography in antenatally discovered pelviureteric stenosis: a short review of the literature

    International Nuclear Information System (INIS)

    Froekiaer, J.; Eskild-Jensen, A.

    2003-01-01

    Congenital unilateral hydronephrosis is a relatively frequent and often asymptomatic condition diagnosed in utero. The natural history and significance of congenital hydronephrosis on the development and long-term consequences on renal function is not sufficiently known. The present diagnostic methods do not provide prediction of the functional consequences of a potential presence of an obstruction. However, renography is an important method affecting the clinical treatment of children with prenatal unilateral hydronephrosis, and is the only method that satisfactory can provide serial accurate measurements of differential renal function. The present review briefly summarizes the clinical impact of renography in neonatally discovered hydronephrosis in relation to the pathophysiological characteristics of congenital unilateral hydronephrosis. (orig.) [de

  16. UPLC-based metabonomic applications for discovering biomarkers of diseases in clinical chemistry.

    Science.gov (United States)

    Zhao, Ying-Yong; Cheng, Xian-Long; Vaziri, Nosratola D; Liu, Shuman; Lin, Rui-Chao

    2014-10-01

    Metabonomics is a powerful and promising analytic tool that allows assessment of global low-molecular-weight metabolites in biological systems. It has a great potential for identifying useful biomarkers for early diagnosis, prognosis and assessment of therapeutic interventions in clinical practice. The aim of this review is to provide a brief summary of the recent advances in UPLC-based metabonomic approach for biomarker discovery in a variety of diseases, and to discuss their significance in clinical chemistry. All the available information on UPLC-based metabonomic applications for discovering biomarkers of diseases were collected via a library and electronic search (using Web of Science, Pubmed, ScienceDirect, Springer, Google Scholar, etc.). Metabonomics has been used in clinical chemistry to identify and evaluate potential biomarkers and therapeutic targets in various diseases affecting the liver (hepatocarcinoma and liver cirrhosis), lung (lung cancer and pneumonia), gastrointestinal tract (colorectal cancer) and urogenital tract (prostate cancer, ovarian cancer and chronic kidney disease), as well as metabolic diseases (diabetes) and neuropsychiatric disorders (Alzheimer's disease and schizophrenia), etc. The information provided highlights the potential value of determination of endogenous low-molecular-weight metabolites and the advantages and potential drawbacks of the application of UPLC-based metabonomics in clinical setting. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  17. SPECIAL ARTICLE Clinical research

    African Journals Online (AJOL)

    enter a new mind-set since, as Karl Popper reminds us,. 'with each step forward, with each problem which we solve, we not only discover new and unsolved problems, but we also discover that where we believed that we were standing on firm and safe ground, all things were in truth insecure and in a state of flux'.' Indeed ' ...

  18. A case series of clinically undiagnosed hematopoietic neoplasms discovered at autopsy.

    Science.gov (United States)

    Podduturi, Varsha; Guileyardo, Joseph M; Soto, Luis R; Krause, John R

    2015-06-01

    In the United States, autopsy rates have diminished to less than 5% during the last half of the 20th century and the beginning of the 21st century for a multitude of reasons. Many believe this results in unrecognized malignancies that could have explained a patient's death. We describe six deaths in which hematopoietic neoplasms were identified at autopsy but were not diagnosed clinically. The six undiagnosed hematopoietic malignancy cases discovered at autopsy include four men and two women ranging from 50 to 78 years of age. One patient was African American and five patients were white, all with multiple comorbidities. The tumors included diffuse large B-cell lymphoma, activated B-cell type, intravascular large B-cell lymphoma, ALK-negative anaplastic large cell lymphoma arising in a setting of human immunodeficiency virus, and a myeloid sarcoma. These cases illustrate the importance of the traditional postmortem examination in not only confirming clinical diagnoses but also identifying previously unknown diagnoses. Hematologic malignancies may present with nonspecific clinical manifestations, and this series of cases also emphasizes the necessity for widening the differential diagnosis in patients with unexplained lactic acidosis and hepatic failure to include hematopoietic malignancies since prompt treatment may be lifesaving. Copyright© by the American Society for Clinical Pathology.

  19. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... Research Information Find a Study Resources and Publications HIV/AIDS Condition Information NICHD Research Information Find a ... Videos Get to Know NICHD Podcasts and Audio Social Media Join ... aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, ...

  20. Research ethics for clinical researchers.

    Science.gov (United States)

    Harnett, John D; Neuman, Richard

    2015-01-01

    This chapter describes the history of the development of modern research ethics. The governance of research ethics is discussed and varies according to geographical location. However, the guidelines used for research ethics review are very similar across a wide variety of jurisdictions. The paramount importance of protecting the privacy and confidentiality of research participants is discussed at length. Particular emphasis is placed on the process of informed consent, and step-by-step practical guidelines are described. The issue of research in vulnerable populations is touched upon and guidelines are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards. Issues related to scientific misconduct and research fraud are not dealt with in this paper.

  1. Ageism and clinical research.

    Science.gov (United States)

    Briggs, R; Robinson, S; O'Neill, D

    2012-10-01

    Despite being the most significant consumers of health care resources and medications worldwide, recent international research has highlighted the under-representation of older participants from clinical trials. This creates problems for physicians as the patients seen in clinical practice are not representative of those on which medical treatments and interventions have been trialled, and we need to consider whether results (both negative and positive) from these trials are applicable to these patients. Our aim was to gauge whether exclusion of older people was prevalent in research proposals submitted to Dublin teaching hospitals. We audited all clinical research proposals submitted to the Research Ethics committee (REC) covering the teaching hospitals attached to Trinity College Dublin (TCD) from July 2008 to July 2011 inclusive, recording exclusion of patients based on an arbitrary upper age limit. Of the 226 relevant trials studied, 31(13.7%) excluded participants based solely on an arbitrary upper age limit. 22 (9.8%) of the relevant trials were submitted by geriatricians, none of which excluded patients based solely on age. Over 50% (12 of 22) trials submitted by neurology/psychiatry excluded patients based on an upper age limit. The mean upper age limit used over all trials as a cut-off was 69.2 years of age. As well as this, the majority of the remaining trials also contained other exclusion criteria, especially those based on cognitive function which further limited participation of older people. While we found that a significant proportion of clinical trials submitted to the TCD REC still excluded patients based arbitrarily on an upper age limit, participation rates of older people seem to be higher in this Irish centre than that seen in international trials. Significant room for improvement still remains however and there needs to be a promotion of greater awareness of the need for developing, testing and licensing medicines so that it mirrors the

  2. Discovering disease associations by integrating electronic clinical data and medical literature.

    Science.gov (United States)

    Holmes, Antony B; Hawson, Alexander; Liu, Feng; Friedman, Carol; Khiabanian, Hossein; Rabadan, Raul

    2011-01-01

    Electronic health record (EHR) systems offer an exceptional opportunity for studying many diseases and their associated medical conditions within a population. The increasing number of clinical record entries that have become available electronically provides access to rich, large sets of patients' longitudinal medical information. By integrating and comparing relations found in the EHRs with those already reported in the literature, we are able to verify existing and to identify rare or novel associations. Of particular interest is the identification of rare disease co-morbidities, where the small numbers of diagnosed patients make robust statistical analysis difficult. Here, we introduce ADAMS, an Application for Discovering Disease Associations using Multiple Sources, which contains various statistical and language processing operations. We apply ADAMS to the New York-Presbyterian Hospital's EHR to combine the information from the relational diagnosis tables and textual discharge summaries with those from PubMed and Wikipedia in order to investigate the co-morbidities of the rare diseases Kaposi sarcoma, toxoplasmosis, and Kawasaki disease. In addition to finding well-known characteristics of diseases, ADAMS can identify rare or previously unreported associations. In particular, we report a statistically significant association between Kawasaki disease and diagnosis of autistic disorder.

  3. Discovering disease associations by integrating electronic clinical data and medical literature.

    Directory of Open Access Journals (Sweden)

    Antony B Holmes

    Full Text Available Electronic health record (EHR systems offer an exceptional opportunity for studying many diseases and their associated medical conditions within a population. The increasing number of clinical record entries that have become available electronically provides access to rich, large sets of patients' longitudinal medical information. By integrating and comparing relations found in the EHRs with those already reported in the literature, we are able to verify existing and to identify rare or novel associations. Of particular interest is the identification of rare disease co-morbidities, where the small numbers of diagnosed patients make robust statistical analysis difficult. Here, we introduce ADAMS, an Application for Discovering Disease Associations using Multiple Sources, which contains various statistical and language processing operations. We apply ADAMS to the New York-Presbyterian Hospital's EHR to combine the information from the relational diagnosis tables and textual discharge summaries with those from PubMed and Wikipedia in order to investigate the co-morbidities of the rare diseases Kaposi sarcoma, toxoplasmosis, and Kawasaki disease. In addition to finding well-known characteristics of diseases, ADAMS can identify rare or previously unreported associations. In particular, we report a statistically significant association between Kawasaki disease and diagnosis of autistic disorder.

  4. Researchers discover promising new targets for treatment of fatty liver disease | Center for Cancer Research

    Science.gov (United States)

    Researchers have identified potential new drug targets for the prevention and treatment of non-alcoholic fatty liver disease (NAFLD). The new study, which was a collaborative effort between scientists in the Laboratory of Metabolism at CCR and Peking University, was published October 9, 2017, in Nature Medicine. Read more…

  5. Functional histology and possible clinical significance of recently discovered telocytes inside the female reproductive system.

    Science.gov (United States)

    Varga, Ivan; Urban, Ladislav; Kajanová, Marianna; Polák, Štefan

    2016-08-01

    Key discoveries of recent years comprise detection of telocytes. These cells of connective tissue have extremely long cytoplasmic processes through which they form functionally connected spatial networks. Through their processes they mutually contact and functionally connect also cells of the immune system, nerve fibres and smooth muscle cells. They are located in various parts of the female reproductive system where they can perform specifically significant functions, which are summarized in our literature review. Literature regarding "telocytes" and "interstitial Cajal-like cells" was reviewed using scientific databases PubMed/Medline, SCOPUS, and Web of Knowledge. Among other things telocytes regulate peristaltic muscle movements in the uterine tubes. Their decreased activity, e.g., in inflammatory diseases or endometriosis, causes disorders of a transport function through the uterine tubes resulting in infertility or tubal pregnancy. In the uterine myometrium they are, first, responsible for regulation of muscle contraction (in expelling menstrual blood or in childbirth) and, second, they participate also in immune surveillance during embryo implantation. They likely control also uterine involution post partum. Their function in the vagina has not been elucidated yet, but probably they participate in production of slow contraction waves during sexual intercourse. In the mammary gland their function may be to regulate cellular proliferation and apoptosis, thus they may play a role also in the development and growth of tumours. In the placenta, they may monitor and regulate blood flow through chorionic villi and they participate in aetiopathogenesis of preeclampsia. However, all above-mentioned functions of telocytes are purely hypothetic and have been published only recently. Therefore, only further research will demonstrate whether this recently discovered cell population will really play a key role in all processes mentioned, or whether it is just an effort

  6. Research on Methods for Discovering and Selecting Cloud Infrastructure Services Based on Feature Modeling

    Directory of Open Access Journals (Sweden)

    Huamin Zhu

    2016-01-01

    Full Text Available Nowadays more and more cloud infrastructure service providers are providing large numbers of service instances which are a combination of diversified resources, such as computing, storage, and network. However, for cloud infrastructure services, the lack of a description standard and the inadequate research of systematic discovery and selection methods have exposed difficulties in discovering and choosing services for users. First, considering the highly configurable properties of a cloud infrastructure service, the feature model method is used to describe such a service. Second, based on the description of the cloud infrastructure service, a systematic discovery and selection method for cloud infrastructure services are proposed. The automatic analysis techniques of the feature model are introduced to verify the model’s validity and to perform the matching of the service and demand models. Finally, we determine the critical decision metrics and their corresponding measurement methods for cloud infrastructure services, where the subjective and objective weighting results are combined to determine the weights of the decision metrics. The best matching instances from various providers are then ranked by their comprehensive evaluations. Experimental results show that the proposed methods can effectively improve the accuracy and efficiency of cloud infrastructure service discovery and selection.

  7. Discovering Wavelets

    CERN Document Server

    Aboufadel, Edward

    1999-01-01

    An accessible and practical introduction to wavelets. With applications in image processing, audio restoration, seismology, and elsewhere, wavelets have been the subject of growing excitement and interest over the past several years. Unfortunately, most books on wavelets are accessible primarily to research mathematicians. Discovering Wavelets presents basic and advanced concepts of wavelets in a way that is accessible to anyone with only a fundamental knowledge of linear algebra. The basic concepts of wavelet theory are introduced in the context of an explanation of how the FBI uses wavelets

  8. Discovering and annotating fish early life-stage (FELS) adverse outcome pathways: Putting the research strategy into practice

    Science.gov (United States)

    In May 2012, a HESI-sponsored expert workshop yielded a proposed research strategy for systematically discovering, characterizing, and annotating fish early life-stage (FELS) adverse outcome pathways (AOPs) as well as prioritizing AOP development in light of current restrictions ...

  9. Medication problems are frequent and often serious in a Danish emergency department and may be discovered by clinical pharmacists

    DEFF Research Database (Denmark)

    Backer Mogensen, Christian; Thisted, Anette Rehn; Olsen, Inger

    2012-01-01

    Transferring a patient from one health-care sector to another implies a risk of medication errors. It is of interest to evaluate whether a specialist in clinical pharmacy is beneficial for the patients in the emergency departments (ED). The aim of the present study was to report the incidence, ca......, categories and seriousness of medication problems discovered by clinical pharmacists in an ED and to evaluate if it is possible for pharmacists to identify those groups of patients who are most at risk of medication problems....

  10. Clinical research before informed consent.

    Science.gov (United States)

    Miller, Franklin G

    2014-06-01

    Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

  11. Metabolomics and Its Application in the Development of Discovering Biomarkers for Osteoporosis Research

    Science.gov (United States)

    Lv, Huanhuan; Jiang, Feng; Guan, Daogang; Lu, Cheng; Guo, Baosheng; Chan, Chileung; Peng, Songlin; Liu, Baoqin; Guo, Wenwei; Zhu, Hailong; Xu, Xuegong; Lu, Aiping; Zhang, Ge

    2016-01-01

    Osteoporosis is a progressive skeletal disorder characterized by low bone mass and increased risk of fracture in later life. The incidence and costs associated with treating osteoporosis cause heavy socio-economic burden. Currently, the diagnosis of osteoporosis mainly depends on bone mineral density and bone turnover markers. However, these indexes are not sensitive and accurate enough to reflect the osteoporosis progression. Metabolomics offers the potential for a holistic approach for clinical diagnoses and treatment, as well as understanding of the pathological mechanism of osteoporosis. In this review, we firstly describe the study subjects of osteoporosis and bio-sample preparation procedures for different analytic purposes, followed by illustrating the biomarkers with potentially predictive, diagnosis and pharmaceutical values when applied in osteoporosis research. Then, we summarize the published metabolic pathways related to osteoporosis. Furthermore, we discuss the importance of chronological data and combination of multi-omics in fully understanding osteoporosis. The application of metabolomics in osteoporosis could provide researchers the opportunity to gain new insight into the metabolic profiling and pathophysiological mechanisms. However, there is still much to be done to validate the potential biomarkers responsible for the progression of osteoporosis and there are still many details needed to be further elucidated. PMID:27918446

  12. Metabolomics and Its Application in the Development of Discovering Biomarkers for Osteoporosis Research

    Directory of Open Access Journals (Sweden)

    Huanhuan Lv

    2016-12-01

    Full Text Available Osteoporosis is a progressive skeletal disorder characterized by low bone mass and increased risk of fracture in later life. The incidence and costs associated with treating osteoporosis cause heavy socio-economic burden. Currently, the diagnosis of osteoporosis mainly depends on bone mineral density and bone turnover markers. However, these indexes are not sensitive and accurate enough to reflect the osteoporosis progression. Metabolomics offers the potential for a holistic approach for clinical diagnoses and treatment, as well as understanding of the pathological mechanism of osteoporosis. In this review, we firstly describe the study subjects of osteoporosis and bio-sample preparation procedures for different analytic purposes, followed by illustrating the biomarkers with potentially predictive, diagnosis and pharmaceutical values when applied in osteoporosis research. Then, we summarize the published metabolic pathways related to osteoporosis. Furthermore, we discuss the importance of chronological data and combination of multi-omics in fully understanding osteoporosis. The application of metabolomics in osteoporosis could provide researchers the opportunity to gain new insight into the metabolic profiling and pathophysiological mechanisms. However, there is still much to be done to validate the potential biomarkers responsible for the progression of osteoporosis and there are still many details needed to be further elucidated.

  13. Stem-Like Memory T Cells Are Discovered | Center for Cancer Research

    Science.gov (United States)

    T cells are the white blood cells that are the body’s first line of attack against foreign invaders.  When designing immunotherapies to treat cancer the goal is to prolong the immune response of T cells a bit beyond what the body normally does when a bacterium or a virus is encountered.   Nicholas P. Restifo, M.D., working with Luca Gattinoni, M.D., and other colleagues in CCR’s Surgery Branch recently discovered a subset within the human T cell population that may help clinicians to do just  this.

  14. Aspergillus pragensis sp nov discovered during molecular reidentification of clinical isolates belonging to Aspergillus section Candidi

    DEFF Research Database (Denmark)

    Lyskova, Pavlina; Hubka, Vit; Kolarik, Miroslav

    2014-01-01

    The identity of nine clinical isolates recovered from Czech patients and presumptively identified as Aspergillus sp. section Candidi based on colony morphology was revised using sequences of beta-tubulin, calmodulin gene sequence, and internal transcribed spacer rDNA. Six isolates were from suspe...

  15. MR spectroscopy in clinical research

    DEFF Research Database (Denmark)

    Henriksen, O

    1994-01-01

    MR spectroscopy (MRS) offers unique possibilities for non-invasive evaluation of biochemistry in vivo. During recent years there has been a growing body of evidence from clinical research studies on human beings using 31P and 1H MRS. The results indicate that it is possible to evaluate phosphorous...... for non-invasive follow-up of treatment. Taken together, the evidence obtained so far certainly shows some trends for clinical applications of MRS. Methods are now available for the clinical research necessary for establishing routine clinical MRS examinations....... energy metabolism, loss of neurones, and lactate production in a large number of brain diseases. Furthermore, 31P and 1H MRS may be particularly clinically useful in evaluation of various disorders in skeletal muscle. In the heart 31P MRS seems at the moment the most suitable for evaluation of global...

  16. MR spectroscopy in clinical research

    DEFF Research Database (Denmark)

    Henriksen, O

    1994-01-01

    for non-invasive follow-up of treatment. Taken together, the evidence obtained so far certainly shows some trends for clinical applications of MRS. Methods are now available for the clinical research necessary for establishing routine clinical MRS examinations.......MR spectroscopy (MRS) offers unique possibilities for non-invasive evaluation of biochemistry in vivo. During recent years there has been a growing body of evidence from clinical research studies on human beings using 31P and 1H MRS. The results indicate that it is possible to evaluate phosphorous...... energy metabolism, loss of neurones, and lactate production in a large number of brain diseases. Furthermore, 31P and 1H MRS may be particularly clinically useful in evaluation of various disorders in skeletal muscle. In the heart 31P MRS seems at the moment the most suitable for evaluation of global...

  17. Writing a clinical research paper.

    Science.gov (United States)

    Ajao, O G

    1999-05-01

    A well-known unwritten law in institutions of higher learning is that of "Publish or perish". The duties of a University teacher, in order of priority are teaching, research and service. Reasons for writing clinical research papers are to get promoted, to get research grants and to make known, one's findings in order to improve patients' care. Writing papers is also a means of delivering continuous education, therefore publication is essential for any one pursuing an academic career. Research papers can be in the form of case reports, retrospective studies, prospective studies and laboratory or animal research. Two popular formats of writing papers are: The Vancouver Style and the Harvard System.

  18. On research in clinical practice

    Directory of Open Access Journals (Sweden)

    Arun Nanivadekar

    2010-01-01

    Full Text Available Clinical research implies advancing current knowledge about health care by continually developing and testing new ideas about diseases, products, procedures, and strategies. Although this trait is inherent in human nature, it needs to be encouraged, nurtured, groomed, and channelized by creating a suitable atmosphere for it, providing the necessary resources, inculcating the necessary conceptual and manual skills, and rewarding the efforts and achievements suitably. Language, logic, statistics, and psychology play an important role in acquiring and developing research capability. To be socially relevant and economically viable, clinical research will need to partner with patients and their doctors in identifying what their goals of health care are, what they value, and what they are willing to "buy" in terms of goods and services. Besides, clinical research will need to bring on one platform the sponsors, the researchers, the patients, the payers, and the regulators to ensure that they do not work at cross purposes, that the cost of developing health care measures is scaled down through innovative approaches such as large simple trials, sequential trials, early marketing conditional on post-marketing surveillance, and so on. All these will be possible if day-to-day practice is slowly and systemically transformed into the largest laboratory of clinical research, which it ought to be, by forming networks of research-oriented practices, and popularizing the use of data collection and analysis tools such as Epi Info which are in the public domain.

  19. [Research activity in clinical biochemistry

    DEFF Research Database (Denmark)

    Jorgensen, H.L.; Larsen, B.; Ingwersen, P.

    2008-01-01

    BACKGROUND: Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched...... Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained....... RESULTS: 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry...

  20. Visual research in clinical education.

    Science.gov (United States)

    Bezemer, Jeff

    2017-01-01

    The aim of this paper is to explore what might be gained from collecting and analysing visual data, such as photographs, scans, drawings, video and screen recordings, in clinical educational research. Its focus is on visual research that looks at teaching and learning 'as it naturally occurs' in the work place, in simulation centres and other sites, and also involves the collection and analysis of visual learning materials circulating in these sites. With the ubiquity of digital recording devices, video data and visual learning materials are now relatively cheap to collect. Compared to other domains of education research visual materials are not widely used in clinical education research. The paper sets out to identify and reflect on the possibilities for visual research using examples from an ethnographic study on surgical and inter-professional learning in the operating theatres of a London hospital. The paper shows how visual research enables recognition, analysis and critical evaluation of (1) the hidden curriculum, such as the meanings implied by embodied, visible actions of clinicians; (2) the ways in which clinical teachers design multimodal learning environments using a range of modes of communication available to them, combining, for instance, gesture and speech; (3) the informal assessment of clinical skills, and the intricate relation between trainee performance and supervisor feedback; (4) the potentialities and limitations of different visual learning materials, such as textbooks and videos, for representing medical knowledge. The paper concludes with theoretical and methodological reflections on what can be made visible, and therefore available for analysis, explanation and evaluation if visual materials are used for clinical education research, and what remains unaccounted for if written language remains the dominant mode in the research cycle. Opportunities for quantitative analysis and ethical implications are also discussed. © 2016 John Wiley

  1. Discovering Voice: A Participatory Action Research Study with Nurses in Uganda

    Directory of Open Access Journals (Sweden)

    Bonnie Fournier

    2007-06-01

    Full Text Available In this article the authors present findings from a qualitative research study carried out with Ugandan nurses from September 2003 until June 2004. They highlight the process and philosophical basis of participatory action research (PAR by reflecting on the challenges, opportunities, outcomes, and ethical issues encountered during the conduct of the research. In this study PAR fostered a climate in which nurses could engage in collective reflection on their practice, make sense of their experiences, and thereby change their understanding of their work.

  2. Discovering Drugs with DNA-Encoded Library Technology: From Concept to Clinic with an Inhibitor of Soluble Epoxide Hydrolase.

    Science.gov (United States)

    Belyanskaya, Svetlana L; Ding, Yun; Callahan, James F; Lazaar, Aili L; Israel, David I

    2017-05-04

    DNA-encoded chemical library technology was developed with the vision of its becoming a transformational platform for drug discovery. The hope was that a new paradigm for the discovery of low-molecular-weight drugs would be enabled by combining the vast molecular diversity achievable with combinatorial chemistry, the information-encoding attributes of DNA, the power of molecular biology, and a streamlined selection-based discovery process. Here, we describe the discovery and early clinical development of GSK2256294, an inhibitor of soluble epoxide hydrolase (sEH, EPHX2), by using encoded-library technology (ELT). GSK2256294 is an orally bioavailable, potent and selective inhibitor of sEH that has a long half life and produced no serious adverse events in a first-time-in-human clinical study. To our knowledge, GSK2256294 is the first molecule discovered from this technology to enter human clinical testing and represents a realization of the vision that DNA-encoded chemical library technology can efficiently yield molecules with favorable properties that can be readily progressed into high-quality drugs. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  3. Island Explorations: Discovering Effects of Environmental Research-Based Lab Activities on Analytical Chemistry Students

    Science.gov (United States)

    Tomasik, Janice Hall; LeCaptain, Dale; Murphy, Sarah; Martin, Mary; Knight, Rachel M.; Harke, Maureen A.; Burke, Ryan; Beck, Kara; Acevedo-Polakovich, I. David

    2014-01-01

    Motivating students in analytical chemistry can be challenging, in part because of the complexity and breadth of topics involved. Some methods that help encourage students and convey real-world relevancy of the material include incorporating environmental issues, research-based lab experiments, and service learning projects. In this paper, we…

  4. Research findings with clinical implications.

    Science.gov (United States)

    Bjugn, Roger

    2015-05-05

    Medical and health research may yield findings that are of direct clinical significance for project participants. The Council of Europe has stated that information on such findings shall be offered to participants, and that applications to research ethics committees shall include plans for managing such findings. The purpose of the study was to investigate how the management of such findings had been described in research projects that had been granted prior approval by a regional committee for medical and health research ethics (REK). Research projects that were associated with Oslo University Hospital and had a start-up date in 2011 were identified in the database of the regional ethics committee. Copies of the application form submitted to the committee, project protocols, participant information/consent forms and letters of approval were reviewed with regard to information on the management of findings with possible clinical implications. Of the 87 projects found in the database, 70 were included in the study. Of these, 57 studies involved direct interaction with humans, whereof 45 with intended use of biological material. In 21 studies, the management of findings with possible clinical implications was described in one or more documents. In all of these projects, the applicant him-/herself had referred to this topic in the initial application. The absence of written information on the management of research findings with possible clinical implications is not in conformity with the recommendations issued by the Council of Europe. By introducing a separate item for this in the form to be submitted to the regional ethics committee for application of prior approval, this issue could be made subject to better assessment.

  5. Bias in clinical intervention research

    DEFF Research Database (Denmark)

    Gluud, Lise Lotte

    2006-01-01

    Research on bias in clinical trials may help identify some of the reasons why investigators sometimes reach the wrong conclusions about intervention effects. Several quality components for the assessment of bias control have been suggested, but although they seem intrinsically valid, empirical...... evidence is needed to evaluate their effects on the extent and direction of bias. This narrative review summarizes the findings of methodological studies on the influence of bias in clinical trials. A number of methodological studies suggest that lack of adequate randomization in published trial reports...

  6. NIH Clinical Research Trials and You

    Science.gov (United States)

    ... Info Lines Health Services Locator HealthCare.gov NIH Clinical Research Trials and You Talking to Your Doctor Science ... Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation and Guidance More » Quick Links ...

  7. Discovering research value in the Campo del Cielo, Argentina, meteorite craters

    Science.gov (United States)

    Cassidy, William A.; Renard, Marc L.

    1996-07-01

    The Campo del Cielo meteorite crater field in Argentina contains at least 20 small meteorite craters, but a recent review of the field data and a remote sensing study suggest that there may be more. The fall occurred ˜4000 years ago into a uniform loessy soil, and the craters are well enough preserved so that some of their parameters of impact can be determined after excavation. The craters were formed by multi-ton fragments of a type IA meteoroid with abundant silicate inclusions. Relative to the horizontal, the angle of infall was ˜9°. Reflecting the low angle of infall, the crater field is elongated with apparent dimensions of 3 × 18.5 km. The largest craters are near the center of this ellipse. This suggests that when the parent meteoroid broke apart, the resulting fragments diverged from the original trajectory in inverse relation to their masses and did not undergo size sorting due to atmospheric deceleration. The major axis of the crater field as we know it extends along N63°E, but the azimuths of infall determined by excavation of Craters 9 and 10 are N83.5°E and N75.5°E, respectively. This suggests that the major axis of the crater field is not yet well determined. The three or four largest craters appear to have been formed by impacts that disrupted the projectiles, scattering fragments around the outsides of the craters and leaving no large masses within them; these are relatively symmetrical in shape. Other craters are elongated features with multi-ton masses preserved within them and no fragmentation products outside. There are two ways in which field research on the Campo del Cielo crater field is found to be useful. (1) Studies exist that have been used to interpret impact craters on planetary surfaces other than the Earth. This occurrence of a swarm of projectiles impacting at known angles and similar velocities into a uniform target material provides an excellent field site at which to test the applicability of those studies. (2) Individual

  8. Research and clinical practice relationship

    Directory of Open Access Journals (Sweden)

    Ashammakhi N

    2008-01-01

    Full Text Available To The Editor: I highly value and greet the authors for their editorial. Many important issues related to medical education and its future in Libya have been discussed in this paper [1]. One important point that has been addressed and I feel deserves attention is the “abnormal” relationship between clinical practice and research in Libya. From discussions with colleagues, this problem somehow has evolved from a misconception about educational and training systems that may have occurred in the past. It may also be related to the lack of attention to research that has long existed in Libya [2,3]. The other aspect, shared with many other developing countries, is the misconception of research as unimportant or a luxury aspect of medicine. When it comes to understanding how a system (including healthcare can be updated and developed, the answer is vague! One important reason is a lack of understanding of the impact that research has on developing methods. In developed countries, research is the main academic distinction that leads to appointments for coveted positions in the system and is an important factor for academic promotion. In Libya, there remain arguments about who will be awarded Chair of university clinical departments. Such a post should no doubt be given to those with established academic achievements. When highly qualified persons are at the top of the pyramid this leads to further progress and enhanced research and advancement. The authors have discussed the point of having proper search committees for leadership and faculty positions. I believe that it will help eliminate the current stagnation and help to create innovative solutions. This should lead to improved medical education, health services, and ultimately impact the quality of life of all Libyan citizens.

  9. Frequently Asked Questions about Clinical Research

    Science.gov (United States)

    ... You Ask? [cdc.gov]. Clinical Research at NHGRI Clinical researchers at the National Human Genome Research Institute (NHGRI) are developing advanced methods for studying the fundamental mechanisms of inherited and ...

  10. Discovering Technicolor

    DEFF Research Database (Denmark)

    R. Andersen, J.; Antipin, O.; Azuelos, G.

    2011-01-01

    We provide a pedagogical introduction to extensions of the Standard Model in which the Higgs is composite. These extensions are known as models of dynamical electroweak symmetry breaking or, in brief, Technicolor. Material covered includes: motivations for Technicolor, the construction of underly...... the relevant experimental benchmarks for Vanilla, Running, Walking, and Custodial Technicolor, and a natural fourth family of leptons, by laying out the framework to discover these models at the Large Hadron Collider....... of underlying gauge theories leading to minimal models of Technicolor, the comparison with electroweak precision data, the low energy effective theory, the spectrum of the states common to most of the Technicolor models, the decays of the composite particles and the experimental signals at the Large Hadron...... Collider. The level of the presentation is aimed at readers familiar with the Standard Model but who have little or no prior exposure to Technicolor. Several extensions of the Standard Model featuring a composite Higgs can be reduced to the effective Lagrangian introduced in the text. We establish...

  11. Stuttering: Clinical and research update.

    Science.gov (United States)

    Perez, Hector R; Stoeckle, James H

    2016-06-01

    To provide an update on the epidemiology, genetics, pathophysiology, diagnosis, and treatment of developmental stuttering. The MEDLINE and Cochrane databases were searched for past and recent studies on the epidemiology, genetics, pathophysiology, diagnosis, and treatment of developmental stuttering. Most recommendations are based on small studies, limited-quality evidence, or consensus. Stuttering is a speech disorder, common in persons of all ages, that affects normal fluency and time patterning of speech. Stuttering has been associated with differences in brain anatomy, functioning, and dopamine regulation thought to be due to genetic causes. Attention to making a correct diagnosis or referral in children is important because there is growing consensus that early intervention with speech therapy for children who stutter is critical. For adults, stuttering can be associated with substantial psychosocial morbidity including social anxiety and low quality of life. Pharmacologic treatment has received attention in recent years, but clinical evidence is limited. The mainstay of treatment for children and adults remains speech therapy. A growing body of research has attempted to uncover the pathophysiology of stuttering. Referral for speech therapy remains the best option for children and adults. Copyright© the College of Family Physicians of Canada.

  12. 59th Clinical Research Division Research Day Briefing

    Science.gov (United States)

    2016-10-27

    59th Medical Wing a ’r’. ’ ( ~ ~ ’ ""· ~... ’ .,,,. lS! lflof!’~l. 59th Clinical Research Division Research Day Briefing Colonel Linda Steel...oversight and guidance to researchers in the development, performance, and dissemination of clinical investigations. CRD directly supports wing... Clinical Investigation Support 2. Training 3. Support of RDT&E protocols 4. Research Subject Protection • Human Subjects: IRS - Institutional

  13. Hypothesis Validity of Clinical Research.

    Science.gov (United States)

    Wampold, Bruce E.; And Others

    1990-01-01

    Describes hypothesis validity as extent to which research results reflect theoretically derived predictions about relations between or among constructs. Discusses role of hypotheses in theory testing. Presents four threats to hypothesis validity: (1) inconsequential research hypotheses; (2) ambiguous research hypotheses; (3) noncongruence of…

  14. Dissemination of research in clinical nursing journals.

    Science.gov (United States)

    Oermann, Marilyn H; Nordstrom, Cheryl K; Wilmes, Nancy A; Denison, Doris; Webb, Sue A; Featherston, Diane E; Bednarz, Hedi; Striz, Penelope; Blair, Darlene A; Kowalewski, Kathleen

    2008-01-01

    The purposes of the study were to describe the extent of research, clinical and evidence-based practice articles published in clinical nursing journals and to explore the communication of research and practice knowledge in the clinical nursing literature using citation analysis. For nursing research to have an impact on clinical practice and build evidence for practice, findings from research must transfer into the clinical practice literature. By analysing the extent of research published in clinical nursing journals, the citations in those articles, and other characteristics of the nursing literature, we can learn more about the linkages between research and practice in nursing. This was a descriptive study of 768 articles and 18901 citations in those articles. Feature articles were classified into four groups - (i) original research reports; (ii) clinical practice articles (non-data based papers on a clinical topic); (iii) systematic reviews, integrative literature reviews, guidelines and papers describing evidence-based practice; and (iv) others. Each citation was then examined to determine if it was a reference to a research study or to a document on clinical practice. Nearly a third of the articles in clinical nursing journals were reports on research studies; another third addressed clinical practice. Of the 14232 citations analysed in clinical nursing journals, 6142 were to research reports (43.2%) and about the same number of citations were to clinical documents (n = 5844, 41.1%). Medical research articles were cited most frequently - 27.1% of the citations in clinical journal articles. Nursing research articles were only 7.6% of the cited documents in clinical publications. Dissemination of research findings in the clinical nursing literature occurred at two levels: through articles that reported studies of potential value to the nurse's practice and citations to research publications within articles. Relevance to clinical practice. Disseminating research

  15. Clinical research: Should patients pay to play?

    Science.gov (United States)

    Emanuel, Ezekiel J; Joffe, Steven; Grady, Christine; Wendler, David; Persad, Govind

    2015-07-29

    Permitting patients to pay for participation in clinical research threatens the principles of social value and fair subject selection as well as robust clinical trial design. Copyright © 2015, American Association for the Advancement of Science.

  16. Research leadership: should clinical directors be distinguished researchers?

    Science.gov (United States)

    Allison, Stephen; Goodall, Amanda H; Bastiampillai, Tarun

    2016-06-01

    Clinical directors established research-led healthcare by combining research, teaching and clinical excellence within the teaching hospitals. This research culture created high clinical standards, which benefited patients, the workforce and healthcare organisations. The current paper explores this research leadership role for clinical directors. It reviews studies arising from the theory of expert leadership, which focuses on the relationship between a leader's core knowledge and organisational performance. More specifically, we examine the expert leader's research track record, the associations with their organisation's performance, and the influence of research activity on clinical excellence. Distinguished researchers still lead the most prestigious teaching hospitals and the most trusted departments of psychiatry in the United States where the clinical directorate structure originated. It is also known that good scholars can improve research output when appointed to leadership positions. This suggests that the clinical director's research track record should be a consideration at a time when research is being embedded in Australia's local health networks. A clinical director's leadership may influence the research performance of their department and contribute to the quality of mental healthcare. © The Royal Australian and New Zealand College of Psychiatrists 2015.

  17. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  18. Extending the rails: how research reshapes clinics.

    Science.gov (United States)

    Petty, JuLeigh; Heimer, Carol A

    2011-06-01

    The purpose of clinical research is to create the scientific foundation for medical practice. In this way of thinking, the effect on medical practice occurs after the research has been completed. Social studies of science have debunked the standard model of scientific research, observing that changes in practice associated with research occur not just because of the results of research but also because of the practice of research. Drawing on fieldwork in HIV clinics in the US, South Africa,Thailand, and Uganda, we argue that clinical trials shape medical practice by altering the organizations in which both medical treatment and clinical trials take place. Three general processes are central to this transformation: the modification of material environments, the reorganization of bureaucratic relations, and the prioritization of research values. These processes unfold somewhat differently in the clinics of poorer countries than in those of wealthier ones.

  19. Infectious Disease Clinical Research Program (IDCRP)

    Data.gov (United States)

    Federal Laboratory Consortium — Our mission is to conduct infectious disease clinical research of importance to the military through a unique, adaptive, and collaborative network, to inform health...

  20. Clinical research on corneal perforation

    Directory of Open Access Journals (Sweden)

    Cheng-Huan Dong

    2014-08-01

    Full Text Available AIM: To study the clinical characteristics of corneal perforation(CP.METHODS: A retrospective analysis in July 1995 to July 2010 the First Affiliated Hospital of Fujian Medical University diagnosed CP 72 patients(72 eyes, clinical characteristics of all the patients were analyzed. RESULTS: The incidence of corneal ulcer perforation rised year by year, the morbidity of male and female was 17:7, the onset age focused on 48 years old. Of 23 industrial workers(32%with clear history of trauma, pathogeny identification results: top two: fungal infection and Acanthamoeba keratitis. A using history of glucocorticoid was found in 10 cases. CONCLUSION: There are plenty of primary causes of CP such as traumas, fungal infection, Acanthamoeba keratitis, eroded keratitis, etc. CP happens in middle-aged males in Fujian province, most traumas are the causes, the main pathogenic bacteria is fungal infection.

  1. The importance of Clinical Research

    Directory of Open Access Journals (Sweden)

    Frank Lizaraso Caparó

    2016-01-01

    Full Text Available Objetives: to describe the clinical and epidemiological characteristics, evolution and to identify mortality factors associated in patients with snp.Material and methods: descriptive study of a serie of cases of the intensive care unit (icu of a general hospital. medical records of patients which received medical attention and who meet the selection criteria were reviewed. Results: forty-one clinical records were evaluated. the average age was 69 old, predominantly male (68,3%. snp was the reason of admission in 60.9% and 95.1% required mechanical ventilation. hospital stay prior to diagnosis was 10 days, 65% of patients had some risk factor for multi resistence organisms, cpis of entry was 9.3, cultures were positive in 39% of the cases and of these, 48.8% received proper antibiotic according to culture results. the days of stay in icu were 20.6 days and 20 of the 41 medical records were for death patients. the clinical and epidemiological characteristics were similar between death and alive patients. an analysis of factors that could be associated with mortality snp was made and it was found that for an age ≥ 70 years, the presence of any risk factor for multidrug resistence organism and control cpis ≥ 6 were associated with higher mortality; while acquisition of the icu was associated to lower mortality. Conclusions: the clinical, epidemiological characteristics and evolution of patients with snp in our icu were similar to those describe in the literature. three factors associated with mortality in the icu were identified.

  2. Database on veterinary clinical research in homeopathy.

    Science.gov (United States)

    Clausen, Jürgen; Albrecht, Henning

    2010-07-01

    The aim of the present report is to provide an overview of the first database on clinical research in veterinary homeopathy. Detailed searches in the database 'Veterinary Clinical Research-Database in Homeopathy' (http://www.carstens-stiftung.de/clinresvet/index.php). The database contains about 200 entries of randomised clinical trials, non-randomised clinical trials, observational studies, drug provings, case reports and case series. Twenty-two clinical fields are covered and eight different groups of species are included. The database is free of charge and open to all interested veterinarians and researchers. The database enables researchers and veterinarians, sceptics and supporters to get a quick overview of the status of veterinary clinical research in homeopathy and alleviates the preparation of systematical reviews or may stimulate reproductions or even new studies. 2010 Elsevier Ltd. All rights reserved.

  3. Media | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The Office of Cancer Clinical Proteomics Research (OCCPR) is committed to providing the media with timely and accurate information.  This section offers key resources for patients, cancer researchers, physicians, and media professionals.

  4. Improvement of Clinical Skills through Pharmaceutical Education and Clinical Research.

    Science.gov (United States)

    Ishizaki, Junko

    2017-01-01

    Professors and teaching staff in the field of pharmaceutical sciences should devote themselves to staying abreast of relevant education and research. Similarly those in clinical pharmacies should contribute to the advancement of pharmaceutical research and the development of next generation pharmacists and pharmaceuticals. It is thought that those who work in clinical pharmacies should improve their own skills and expertise in problem-finding and -solving, i.e., "clinical skills". They should be keen to learn new standard treatments based on the latest drug information, and should try to be in a position where collecting clinical information is readily possible. In the case of pharmacists in hospitals and pharmacies, they are able to aim at improving their clinical skills simply through performing their pharmaceutical duties. On the other hand, when a pharmaceutical educator aims to improve clinical skills at a level comparable to those of clinical pharmacists, it is necessary to devote or set aside considerable time for pharmacist duties, in addition to teaching, which may result in a shortage of time for hands-on clinical practice and/or in a decline in the quality of education and research. This could be a nightmare for teaching staff in clinical pharmacy who aim to take part in such activities. Nonetheless, I believe that teaching staff in the clinical pharmacy area could improve his/her clinical skills through actively engaging in education and research. In this review, I would like to introduce topics on such possibilities from my own experiences.

  5. Chloracne: From clinic to research

    Directory of Open Access Journals (Sweden)

    Qiang Ju

    2012-03-01

    Full Text Available Chloracne is the most sensitive and specific marker for a possible dioxin (2,3,7,8-tetrachlorodibenzo-p-dioxin intoxication. It is clinically characterized by multiple acneiform comedone-like cystic eruptions mainly involving face in the malar, temporal, mandibular, auricular/retroauricular regions, and the genitalia, often occurring in age groups not typical for acne vulgaris. Histopathology is essential for a definite diagnosis, which exhibits atrophy or absence of sebaceous glands as well as infundibular dilatation or cystic formation of hair follicles, hyperplasia of epidermis, and hyperpigmentation of stratum corneum. The appearance of chloracne and its clinical severity does not correlate with the blood levels of dioxins. Pathogenesis of chloracne remains largely unclear. An “aryl hydrocarbon receptor”-mediated signaling pathway affecting the multipotent stem cells in the pilosebaceous units is probably the major molecular mechanism inducing chloracne. Chloracne is resistant to all the available treatment modalities used to treat acne. The aim of treatment is to lower or to eliminate the accumulated dioxins in the body at the very beginning of intoxication, e.g., by using dioxin-chelating substances such as synthetic dietary fat substitutes. The problem of dioxin contamination and its potential health hazards should be taken seriously in the wave of industrial globalization in the twenty-first century. Clinicians, especially dermatologists, are in the forefront of early diagnosis of dioxin intoxication.

  6. Developing Clinical Research Relationship: Views from Within.

    Science.gov (United States)

    Zvonareva, Olga; Akrong, Lloyd

    2015-12-01

    The nature of the relationship between clinical investigator and research participant continues to be contested. The related discussions have largely focused on the doctor-researcher dichotomy thought to permeate the work of a clinical investigator with research participants, whom in turn occupy two corresponding roles: patient and subject. This paper contributes to current debates on the topic by providing a voice to research participants, whose perspectives have been largely invisible. It draws on 42 in-depth interviews conducted in Ghana and South Africa with respondents at different stages of involvement in clinical research, ranging from no experience in clinical research to enrollment in several clinical trials. The perspectives of all respondents were largely congruent and rooted in the common view that clinical research contributed to the improvement of local health. They went beyond the researcher/participant versus doctor/patient dichotomy, long established in research ethics, and preferred to view participants and investigators as partners working together to find ways to address local health needs. The conceptualization of investigator-participant relations as a partnership reinforced expectations of care, transparency and accountability, which were viewed as necessary expressions of mutuality and respect within equal collaborations. It is important to engage with these views in order to avoid antagonizing societal expectations and to build up long-term public trust, crucial for the continuous operation of clinical research. © 2014 John Wiley & Sons Ltd.

  7. Discovering treatment pattern in Traditional Chinese Medicine clinical cases by exploiting supervised topic model and domain knowledge.

    Science.gov (United States)

    Yao, Liang; Zhang, Yin; Wei, Baogang; Wang, Wei; Zhang, Yuejiao; Ren, Xiaolin; Bian, Yali

    2015-12-01

    In Traditional Chinese Medicine (TCM), the prescription is the crystallization of clinical experience of doctors, which is the main way to cure diseases in China for thousands of years. Clinical cases, on the other hand, describe how doctors diagnose and prescribe. In this paper, we propose a framework which mines treatment patterns in TCM clinical cases by exploiting supervised topic model and TCM domain knowledge. The framework can reflect principle rules in TCM and improve function prediction of a new prescription. We evaluate our method on 3090 real world TCM clinical cases. The experiment validates the effectiveness of our method. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Antiphospholipid Syndrome Clinical Research Task Force Report

    NARCIS (Netherlands)

    Erkan, D.; Derksen, R.; Levy, R.; Machin, S.; Ortel, T.; Pierangeli, S.; Roubey, R.; Lockshin, M.

    The Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) was one of six Task Forces developed by the 13(th) International Congress on Antiphospholipid Antibodies (aPL) organization committee with the purpose of: a) evaluating the limitations of APS clinical research and developing

  9. Qualitative research: adding drive and dimension to clinical research.

    Science.gov (United States)

    Rusinová, Katerĭna; Pochard, Frédéric; Kentish-Barnes, Nancy; Chaize, Marine; Azoulay, Elie

    2009-01-01

    Qualitative research and its methods stem from the social sciences and can be used to describe and interpret complex phenomena that involve individuals' views, beliefs, preferences, and subjective responses to places and people. Thus, qualitative research explores the many subjective factors that may influence patient outcomes, staff well-being, and healthcare quality, yet fail to lend themselves to the hypothesis-testing approach that characterizes quantitative research. Qualitative research is valuable in the intensive care unit to explore organizational and cultural issues and to gain insight into social interactions, healthcare delivery processes, and communication. Qualitative research generates explanatory models and theories, which can then serve to devise interventions, whose efficacy can be studied quantitatively. Thus, qualitative research works synergistically with quantitative research, providing new impetus to the research process and a new dimension to research findings. Qualitative research starts with conceptualizing the research question, choosing the appropriate qualitative strategy, and designing the study; rigorous methods specifically designed for qualitative research are then used to conduct the study, analyze the data, and verify the findings. The researcher is the data-collecting instrument, and the data are the participants' words and behaviors. Data coding methods are used to describe experiences, discover themes, and build theories. In this review, we outline the rationale and methods for conducting qualitative research to inform critical care issues. We provide an overview of available qualitative methods and explain how they can work in close synergy with quantitative methods. To illustrate the effectiveness of combining different research methods, we will refer to recent qualitative studies conducted in the intensive care unit.

  10. Dissemination of research into clinical nursing literature.

    Science.gov (United States)

    Oermann, Marilyn H; Shaw-Kokot, Julia; Knafl, George J; Dowell, Jo

    2010-12-01

    The purpose of our study was to describe the dissemination of research into the clinical nursing literature. The literature provides a means of transferring knowledge from a research study through citations of the work by other authors. This was a citation analysis study to explore the dissemination of research into the clinical nursing literature, beginning with the publication of an original research study and including all of the citations to that article through 2009. The authors searched five academic nursing research journal titles, using CINAHL, for original research reports that had clinical relevance and were published between 1990-1999. The search process yielded a final data set of 28 research articles. For each of the articles, the authors searched three databases, CINAHL, Web of Science(®) and Google Scholar, to determine the citation patterns from the date of publication to August 2009. All of the research studies were cited in articles published in clinical journals although there was a wide range in the number of citations, from 3-80. The 28 research articles had a total of 759 citations; 717 (94.5%) of those citations were in articles published in clinical nursing journals. The median length of time between publication of the original study and the first citation was 1.5 years. Some of the studies were still being cited for 18 years after publication of the original work. All of the original research reports examined in this study were cited in articles in clinical journals, disseminating the research beyond the original work to reach clinicians. Clinical nursing journals keep readers up-to-date and informed about new practices in nursing and serve another important role: they disseminate research that is clinically relevant by publishing original studies and papers that cite research reports. © 2010 Blackwell Publishing Ltd.

  11. Anatomy and histology of the newly discovered adipose sac structure within the labia majora: international original research.

    Science.gov (United States)

    Ostrzenski, Adam; Krajewski, Pawel; Davis, Kern

    2016-09-01

    To determine whether there is any new anatomical structure present within the labia majora. A case serial study was executed on eleven consecutive fresh human female cadavers. Stratum-by-stratum dissections of the labia majora were performed. Twenty-two anatomic dissections of labia majora were completed. Eosin and Hematoxylin agents were used to stain newly discovered adipose sac's tissues of the labia majora and the cylinder-like structures, which cover condensed adipose tissues. The histology of these two structures was compared. All dissected labia majora demonstrated the presence of the anatomic existence of the adipose sac structure. Just under the dermis of the labia majora, the adipose sac was located, which was filled with lobules containing condensed fatty tissues in the form of cylinders. The histological investigation established that the well-organized fibro-connective-adipose tissues represented the adipose sac. The absence of descriptions of the adipose sac within the labia majora in traditional anatomic and gynecologic textbooks was noted. In this study group, the newly discovered adipose sac is consistently present within the anatomical structure of the labia majora. The well-organized fibro-connective-adipose tissue represents microscopic characteristic features of the adipose sac.

  12. Translational Bioinformatics and Clinical Research (Biomedical) Informatics.

    Science.gov (United States)

    Sirintrapun, S Joseph; Zehir, Ahmet; Syed, Aijazuddin; Gao, JianJiong; Schultz, Nikolaus; Cheng, Donavan T

    2015-06-01

    Translational bioinformatics and clinical research (biomedical) informatics are the primary domains related to informatics activities that support translational research. Translational bioinformatics focuses on computational techniques in genetics, molecular biology, and systems biology. Clinical research (biomedical) informatics involves the use of informatics in discovery and management of new knowledge relating to health and disease. This article details 3 projects that are hybrid applications of translational bioinformatics and clinical research (biomedical) informatics: The Cancer Genome Atlas, the cBioPortal for Cancer Genomics, and the Memorial Sloan Kettering Cancer Center clinical variants and results database, all designed to facilitate insights into cancer biology and clinical/therapeutic correlations. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Clinical anatomy research in a research-driven anatomy department.

    Science.gov (United States)

    Jones, D Gareth; Dias, G J; Mercer, S; Zhang, M; Nicholson, H D

    2002-05-01

    Clinical anatomy is too often viewed as a discipline that reiterates the wisdom of the past, characterized more by description of what is known than by active investigation and critical analysis of hypotheses and ideas. Various misconceptions follow from an acceptance of this premise: the teaching of clinical anatomists is textbook based, there is no clinical anatomy research worthy of the name, and any research that does exist fails to utilize modern technology and does not stand comparison with serious biomedical research as found in cell and molecular biology. The aim of this paper is to challenge each of these contentions by reference to ongoing clinical research studies within this department. It is argued that all teaching (including that of clinical anatomy) should be research-informed and that the discipline of clinical anatomy should have at its base a vigorous research ethos driven by clinically related problems. In interacting with physicians, the role of the clinical anatomist should be to promulgate a questioning scientific spirit, with its willingness to test and challenge accepted anatomic dicta. Copyright 2002 Wiley-Liss, Inc.

  14. Training needs of clinical research associates

    Directory of Open Access Journals (Sweden)

    Samyuktha Ajay

    2010-01-01

    Full Text Available Clinical research is a relatively new field in our country that has seen very rapid growth in the last few years. Availability of personnel appropriately trained to the specific requirements of the role they will perform in clinical research is critical for capacity expansion. Our study attempts to understand the specific areas of knowledge and skills that are important for the role of a clinical research associate. The survey was conducted among clinical research professionals from industry and academia who had more than five years of clinical research experience and held important decision making positions in clinical research (stakeholders. The survey questionnaire was designed as a matrix of various clinical research roles on the y-axis and six knowledge modules and eight skills on the x-axis. Respondents were asked to rate the importance of the knowledge /skills to the role of clinical research associates on a three point scale. In discussing results, a significant response was considered to be 50% or greater positive response from the total group. The significant findings were that general, ethics and clinical trial execution modules were rated as critical for the role of clinical research associate. Regulatory module was rated as important for the role. The other significant responses were that three of the sub-topics in the methodology module - framing a research proposal/protocol and experimental design, designing case report forms and EDCs and conducting PK studies - were rated as important and one sub topic in the data management and statistics module was rated as not important. All the skills except leadership skills were rated as critical for the role. The findings of our survey were in general on the lines of expectations of performance of the role. The general, ethics and clinical trial execution modules are critical knowledge areas for the role of a clinical research associate. No clear trends emerged for some of the other

  15. Retooling institutional support infrastructure for clinical research.

    Science.gov (United States)

    Snyder, Denise C; Brouwer, Rebecca N; Ennis, Cory L; Spangler, Lindsey L; Ainsworth, Terry L; Budinger, Susan; Mullen, Catherine; Hawley, Jeffrey; Uhlenbrauck, Gina; Stacy, Mark

    2016-05-01

    Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can divert investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a similar transition. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  16. Radiopharmacy - clinical reality and selected research demands

    International Nuclear Information System (INIS)

    Hoer, G.

    2001-01-01

    My presentation aims at focusing on clinical reality of 18 F-fluorodeoxyglucose (FDG)-PET in three major medical specialities and to touch some of the demands in clinical PET research out of the sight of my view. Using of FDG in nuclear medicine is reviewed. (author)

  17. Research in clinical laboratory science: professionals' involvement.

    Science.gov (United States)

    Laudicina, Rebecca; Fenn, JoAnn P; Freeman, Vickie; McCoy, Carol; McLane, Mary Ann; Mundt, Lillian; Polancic, Joan; Randolph, Tim; Shanahan, Kristy

    2011-01-01

    To describe current qualitative and quantitative aspects of research engagement and other scholarly activities conducted by clinical laboratory science (CLS) professionals across a range of employment settings. A link to a 3-part online survey was sent by electronic mail to 7,572 members of the American Society for Clinical Laboratory Science and 500 program directors. email message, on-line survey all ASCLS members and all directors of accredited clinical laboratory educational programs Quantitative and qualitative measures of professionals' engagement in research and other scholarly activities 556 of 7572 (7.3%) persons completed the survey. Thirty-two percent of survey respondents reported spending between 1 to > 40 work hours per week conducting research with 68% of respondents not participating in research activities. Conducting research is an employment requirement for 18% of survey participants. Twenty-nine percent of respondents have published at least one research article, and 47% of respondents who conduct research have published studies in the journal Clinical Laboratory Science. More than 57% of respondents participate in non-research scholarly activities as part of their employment. CLS professionals who conduct research are more likely to do applied, clinical, or educational research than other types of research. Fifty-seven percent of respondents who conduct research lack external funding for their work. Ninety-three percent of total research dollars is obtained by respondents who hold the Ph.D. degree. The perception of the importance of conducting research varies by employment position. Barriers to participation in research include lack of inclusion of research in the job description, time constraints, inadequate research funding, limited opportunity, and lack of space and equipment. CLS professionals participate in research in limited numbers, and are more likely to engage in non-research types of scholarly activities. Numerous barriers are

  18. Converging clinical and engineering research on neurorehabilitation

    CERN Document Server

    Torricelli, Diego; Pajaro, Marta

    2013-01-01

    Restoring human motor and cognitive function has been a fascinating research area during the last century. Interfacing the human nervous system with electro-mechanical rehabilitation machines is facing its crucial passage from research to clinical practice, enhancing the potentiality of therapists, clinicians and researchers to rehabilitate, diagnose and generate knowledge. The 2012 International Conference on Neurorehabilitation (ICNR2012, www.icnr2012.org) brings together researchers and students from the fields of Clinical Rehabilitation, Applied Neurophysiology and Biomedical Engineering, covering a wide range of research topics:   · Clinical Impact of Technology · Brain-Computer Interface in Rehabilitation · Neuromotor & Neurosensory modeling and processing · Biomechanics in Rehabilitation · Neural Prostheses in Rehabilitation · Neuro-Robotics in Rehabilitation · Neuromodulation   This Proceedings book includes general contributions from oral and poster sessions, as well as from special sess...

  19. Multicenter clinical research in adult critical care.

    Science.gov (United States)

    Cook, Deborah; Brower, Roy; Cooper, Jamie; Brochard, Laurent; Vincent, Jean-Louis

    2002-07-01

    To describe the development, organization, and operation of several collaborative groups conducting investigator-initiated multicenter clinical research in adult critical care. To review the process by which investigator-initiated critical care clinical research groups were created using examples from Europe, Australia, the United States, and Canada. Various models of group structure and function are discussed, highlighting complementary approaches to protocol development, multicenter study management, and project funding. Published peer review research and unpublished terms of reference documents on the structure and function of these groups. The overall goal of clinical critical care research groups engaged in multicenter studies is to improve patient outcomes through conducting large, rigorous investigations. Research programs we reviewed included the following: a) multicenter epidemiologic studies and surveys; b) technology evaluations of mechanical ventilation; c) investigations focused on three priority fields (acute lung injury, infection, and acute brain injury); d) a series of randomized trials of treatments for one syndrome (acute respiratory distress syndrome); and e) diverse methodologies addressing several clinical problems. The structure and function of these research groups differ according to their historical development, research culture, and enabling resources. Specific protocols emerge from clinical questions generated by investigators or from collectively prioritized research agendas. Project funding includes government support, peer-review grants, intensive care foundations, industry, local hospital funds, and hybrid models. Infrastructure for study management varies widely. Several national and international groups have engaged in investigator-initiated multicenter critical care research. The development, organization, and operational methods of these groups illustrate several collaborative models for clinical investigations in the intensive

  20. Clinical research priorities in emergency medicine.

    Science.gov (United States)

    Keijzers, Gerben; Thom, Ogilvie; Taylor, David; Knott, Jonathan; Taylor, David McD

    2014-02-01

    To determine the clinical research priorities of Fellows of the Australasian College for Emergency Medicine (ACEM) in order to inform the strategic research agenda specific to multicentre clinical research. An anonymous survey of all ACEM Fellows (FACEMs) listed on the ACEM researcher database was conducted between January and March 2013. Of 108 FACEMs invited to participate, 54 (50%) responded. Over half of respondents (61%) had a higher research degree but only a minority (24%) had funded research positions. The top research categories identified as priorities were resuscitation, trauma, cardiology, ED ultrasound, acute behavioural disturbance and geriatrics. The most common specific sub-categories included anterior chest pain, fluid resuscitation in trauma, and drug therapy for both atrial fibrillation and acute behavioural disturbance. Several specific research questions related to chest pain, resuscitation/sepsis, stroke, paediatrics and pulmonary embolus. The findings provide guidance and support for research areas amenable to collaborative multicentre clinical research within emergency medicine. Discussion rounds are planned to translate these perceived research priorities to actual priorities. © 2013 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  1. Statistical reporting of clinical pharmacology research.

    Science.gov (United States)

    Ring, Arne; Schall, Robert; Loke, Yoon K; Day, Simon

    2017-06-01

    Research in clinical pharmacology covers a wide range of experiments, trials and investigations: clinical trials, systematic reviews and meta-analyses of drug usage after market approval, the investigation of pharmacokinetic-pharmacodynamic relationships, the search for mechanisms of action or for potential signals for efficacy and safety using biomarkers. Often these investigations are exploratory in nature, which has implications for the way the data should be analysed and presented. Here we summarize some of the statistical issues that are of particular importance in clinical pharmacology research. © 2017 The British Pharmacological Society.

  2. Patient safety in clinical research articles.

    Science.gov (United States)

    Vintzileos, Anthony M; Finamore, Peter S; Sicuranza, Genevieve B; Ananth, Cande V

    2013-11-01

    Patient safety has remained one of the most important priorities over the past decade, particularly in hospital settings. Implementation of patient safety measures has focused not only on reducing medication and surgical errors but also on the development of a culture of safety, including enhanced communication among all healthcare stakeholders. Academic medicine may further contribute to the culture of safety if all relevant clinical article submissions address patient safety. In order to improve communication between the authors of clinical research articles and practicing physicians, we propose that each clinical research article may be accompanied by a clear statement from the authors regarding practice implications and patient safety. © 2013.

  3. The clinical applicability of music therapy research

    DEFF Research Database (Denmark)

    Wigram, Anthony Lewis

    practitioners in all three areas (and beyond) can demonstrate, through previous and current research, that the music therapy service and interventions they provide are relevant and effective (Ansdell, Pavicevic & Proctor, 2004; Gold, Voracek and Wigram, 2004; Vink, 2003; Wigram 2002). Documentation of research......Research serves the functions of informing the clinical field, guiding future research, establishing new knowledge and theory, and meeting criteria for evidence based practice. Given the demands of health, education and social services today and there is an increasing expectation that clinical...... in lengthy and complex theses is seldom accessible to the practitioner working ‘at the coal-face’; and sometimes lacks clear direction on how the results are applicable in everyday therapy. For results to be implemented in clinical practice and disseminated to colleagues in related fields as well as senior...

  4. Research Issues in Clinical Data Warehousing

    DEFF Research Database (Denmark)

    Pedersen, Torben Bach; Jensen, Christian Søndergaard

    1998-01-01

    to data warehousing technologies, over those posed by conventional data warehouse applications. This article presents a number of exciting new research challenges posed by clinical applications, to be met by the database research community. These include the need for complex-data modeling features......Medical informatics has been an important area for the application of computing and database technology for at least four decades. This area may benefit from the functionality offered by data warehousing. However, the special nature of clinical applications poses different and new requirements......, advanced temporal support, advanced classification structures, continuously valued data, dimensionally reduced data, and the integration of very complex data. In addition, the support for clinical treatment protocols and medical research are interesting areas for research....

  5. Ethics in clinical research: the Indian perspective.

    Science.gov (United States)

    Sanmukhani, J; Tripathi, C B

    2011-03-01

    Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

  6. Electronic health records to facilitate clinical research.

    Science.gov (United States)

    Cowie, Martin R; Blomster, Juuso I; Curtis, Lesley H; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, Jörg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P; Southworth, Mary Ross; Stough, Wendy Gattis; Thoenes, Martin; Zannad, Faiez; Zalewski, Andrew

    2017-01-01

    Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.

  7. Clinical outcomes research in gynecologic oncology.

    Science.gov (United States)

    Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

    2017-09-01

    Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

  8. Public information about clinical trials and research.

    Science.gov (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

  9. The Clinical Research Landscape in Rhode Island.

    Science.gov (United States)

    Mao, George; Ramratnam, Bharat

    2017-01-06

    To present an overview of clinical research activity and the state of medical research funding in Rhode Island. We utilized clinicaltrials.gov registry to profile clinical studies between 2011 to 2016. NIH RePORT and other federal databases were used to extract information on levels of federal funding. Previously published hospital financial reports were reviewed for data on hospital-specific total external research funding. During 2011-2016, 1651 clinical studies were registered in clinicaltrials.gov. Nearly a third of all clinical studies were in oncology (21%) and cardiovascular diseases (10%). Alzheimer's dementia, breast cancer, HIV, and hepatitis C accounted for nearly 17% of all clinical trials. Seventy-five percent (75%) of clinical trials in RI were conducted in hospitals affiliated with Lifespan or Care New England. Financial support for clinical trials largely came from industry (60%) with 23% being supported by the National Institutes of Health (NIH). The rest are funded by nonprofit organizations, charitable foundations, educational institutions, and unlisted concerns. [Full article available at http://rimed.org/rimedicaljournal-2017-01.asp].

  10. Clinical application and research of tumor markers in colorectal cancer

    International Nuclear Information System (INIS)

    Chen Yumei

    2005-01-01

    Colorectal cancer is one of the most common malignant tumors. There are many tumor markers for detecting colorectal cancer, some of which have been widely used in clinical area. However, still lack an ideal tumor marker of colorectal cancer. In this review, we simply characterized some common tumor markers including carcinoembryonic antigen, CA19-9, CA50, CA242 etc and their dignostic value. And here we discussed some combined detecting procedures which improve diagnostic accuracy of colorectal cancer. In addition, with the development of the biomoleculer technique, some newly discovered tumor markers and genetic marekers have gained great progress in the research of colorectal cancer, and will become a promissing technique in the diagnosis of colorectal cancer. (authors)

  11. A Novel Repressor of the ica Locus Discovered in Clinically Isolated Super-Biofilm-Elaborating Staphylococcus aureus

    Directory of Open Access Journals (Sweden)

    Liansheng Yu

    2017-01-01

    Full Text Available Staphylococcus aureus TF2758 is a clinical isolate from an atheroma and a super-biofilm-elaborating/polysaccharide intercellular adhesin (PIA/poly-N-acetylglucosamine (PNAG-overproducing strain (L. Shrestha et al., Microbiol Immunol 60:148–159, 2016, https://doi.org/10.1111/1348-0421.12359. A microarray analysis and DNA genome sequencing were performed to identify the mechanism underlying biofilm overproduction by TF2758. We found high transcriptional expression levels of a 7-gene cluster (satf2580 to satf2586 and the ica operon in TF2758. Within the 7-gene cluster, a putative transcriptional regulator gene designated rob had a nonsense mutation that caused the truncation of the protein. The complementation of TF2758 with rob from FK300, an rsbU-repaired derivative of S. aureus strain NCTC8325-4, significantly decreased biofilm elaboration, suggesting a role for rob in this process. The deletion of rob in non-biofilm-producing FK300 significantly increased biofilm elaboration and PIA/PNAG production. In the search for a gene(s in the 7-gene cluster for biofilm elaboration controlled by rob, we identified open reading frame (ORF SAOUHSC_2898 (satf2584. Our results suggest that ORF SAOUHSC_2898 (satf2584 and icaADBC are required for enhanced biofilm elaboration and PIA/PNAG production in the rob deletion mutant. Rob bound to a palindromic sequence within its own promoter region. Furthermore, Rob recognized the TATTT motif within the icaR-icaA intergenic region and bound to a 25-bp DNA stretch containing this motif, which is a critically important short sequence regulating biofilm elaboration in S. aureus. Our results strongly suggest that Rob is a long-sought repressor that recognizes and binds to the TATTT motif and is an important regulator of biofilm elaboration through its control of SAOUHSC_2898 (SATF2584 and Ica protein expression in S. aureus.

  12. Clinical Research Informatics Contributions from 2015.

    Science.gov (United States)

    Daniel, C; Choquet, R

    2016-11-10

    To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2015. A bibliographic search using a combination of MeSH and free terms search over PubMed on Clinical Research Informatics (CRI) was performed followed by a double-blind review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. A consensus meeting between the two section editors and the editorial team was finally organized to conclude on the selection of best papers. Among the 579 returned papers published in the past year in the various areas of Clinical Research Informatics (CRI) - i) methods supporting clinical research, ii) data sharing and interoperability, iii) re-use of healthcare data for research, iv) patient recruitment and engagement, v) data privacy, security and regulatory issues and vi) policy and perspectives - the full review process selected four best papers. The first selected paper evaluates the capability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) to support the representation of case report forms (in both the design stage and with patient level data) during a complete clinical study lifecycle. The second selected paper describes a prototype for secondary use of electronic health records data captured in non-standardized text. The third selected paper presents a privacy preserving electronic health record linkage tool and the last selected paper describes how big data use in US relies on access to health information governed by varying and often misunderstood legal requirements and ethical considerations. A major trend in the 2015 publications is the analysis of observational, "nonexperimental" information and the potential biases and confounding factors hidden in the data that will have to be carefully taken into account to validate new predictive models. In addiction, researchers have to understand

  13. Heart Failure: From Research to Clinical Practice.

    Science.gov (United States)

    Islam, Md Shahidul

    2018-03-03

    "Heart failure: from research to clinical practice", a collection of selected reviews, which comes out also as a book, covers essentially all important aspects of heart failure, including the pathogenesis, clinical features, biomarkers, imaging techniques, medical treatment and surgical treatments, use of pacemakers and implantable cardioverter defibrillators, and palliative care. The reviews include essential background information, state of the art, critical and in-depth analysis, and directions for future researches for elucidation of the unresolved issues. Everyone interested in heart failure is expected to find this compilation helpful for a deeper understanding of some of the complex issues.

  14. Challenges in conducting clinical nutrition research.

    Science.gov (United States)

    Weaver, Connie M; Miller, Joshua W

    2017-07-01

    Clinical nutrition research has played a pivotal role in establishing causality between diet or nutrient intake and health outcome measures and in the determination of dietary requirements and levels of supplementation to achieve specific outcomes. Because the studies are performed with humans, clinical nutrition research can be readily translated into public health messages. However, there are many challenges and considerations unique to the field, such as the baseline nutritional status of study participants, defining appropriate control groups, effective blinding of participants and investigators, the evolving ethics of randomized control trials, and a tension in a priori decisions regarding inclusion of nutritionally vulnerable participants versus representative samples of general populations. Regulatory approvals that place increasing burdens on the ability of investigators to carry out and complete research protocols have grown dramatically in recent years. There is much room for improved efficiency in the approval and reporting processes aimed at protecting volunteers and providing transparency to the public. Decreased redundancy would have a direct benefit to clinical nutrition research and investigators. Despite these challenges, the information to be gained and the rewards of clinical nutrition research remain high. © The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  15. Progress in clinical research of asteroid hyalosis

    Directory of Open Access Journals (Sweden)

    Xiao-Xue Liu

    2017-08-01

    Full Text Available Asteroid Hyalosis(AHis a common clinical disease, which has been considered a benign disorder as it rarely impairs visual acuity. It was often discovered when the patient was treated for other eye diseases. The mechanism was unclear. Its characteristic B-ultrasound property makes the B-ultrasound a very helpful diagnostic technique. In the case of the patients with other fundus diseases associated with AH, optical coherence tomography(OCTand fluorescein angiography(FAmay be used to reduce the interference from asteroid bodies, therefore improve the fundus visibility. Recent studies have shown that AH can incorporate with many other eye diseases. For example, in patients with cataracts, asteroid hyalosis can cause surface calcification of silicone plate intraocular lenses, which in most cases may lead to the need for explantation of the calcified intraocular lenses. The efficacy of pars plana vitrectomy(PPV, the removal of some, or all, of the eye's vitreous humor for AH remains controversial. In this paper, we provide a review of the recent literature on AH disease: the etiology, diagnosis and treatment. We hope to thus improve the awareness and outcomes of AH disease.

  16. Budgeting, funding, and managing clinical research projects.

    Science.gov (United States)

    Hatfield, Elizabeth; Dicks, Elizabeth; Parfrey, Patrick

    2009-01-01

    Large, integrated multidisciplinary teams have become recognized as an efficient means by which to drive innovation and discovery in clinical research. This chapter describes how to budget and fund these large studies and effectively manage the large, often dispersed teams involved. Sources of funding are identified; budget development, justification, reporting, financial governance, and accountability are described; in addition to the creation and management of the multidisciplinary team that will implement the research plan.

  17. Novartis School Lab: bringing young people closer to the world of research and discovering the excitement of science.

    Science.gov (United States)

    Michel, Christiane Röckl; Standke, Gesche; Naef, Reto

    2012-01-01

    The Novartis School Lab (http://www.novartis.ch/schullabor) is an institution with an old tradition. The School Lab reaches about 5000 students through internal courses and an additional 5000 children at public science events where they can enjoy hands-on science in disciplines of biomedical research. The subjects range from chemistry, physics, molecular biology and genetics to toxicology and medical topics. The Novartis School Lab offers a variety of activities for youngsters aged 10-20 ranging from lab courses for school classes, continuing education for teachers and development of teaching kits, support for individual research projects to outreach for public science events. Innovation and adaptation to changes of current needs are essential aspects for the Novartis School Lab. Ongoing activities to shape the Novartis Biomedical Learning Lab include design of new teaching experiments, exploration into additional disciplines of biomedical science and the creation of a fascinating School Lab of the future.

  18. Blockchain technology for improving clinical research quality.

    Science.gov (United States)

    Benchoufi, Mehdi; Ravaud, Philippe

    2017-07-19

    Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research. A new technology, Blockchain, may be a key to addressing these challenges and should draw the attention of the whole clinical research community.Blockchain brings the Internet to its definitive decentralisation goal. The core principle of Blockchain is that any service relying on trusted third parties can be built in a transparent, decentralised, secure "trustless" manner at the top of the Blockchain (in fact, there is trust, but it is hardcoded in the Blockchain protocol via a complex cryptographic algorithm). Therefore, users have a high degree of control over and autonomy and trust of the data and its integrity. Blockchain allows for reaching a substantial level of historicity and inviolability of data for the whole document flow in a clinical trial. Hence, it ensures traceability, prevents a posteriori reconstruction and allows for securely automating the clinical trial through what are called Smart Contracts. At the same time, the technology ensures fine-grained control of the data, its security and its shareable parameters, for a single patient or group of patients or clinical trial stakeholders.In this commentary article, we explore the core functionalities of Blockchain applied to clinical trials and we illustrate concretely its general principle in the context of consent to a trial protocol. Trying to figure out the potential impact of Blockchain implementations in the setting of clinical trials will shed new light on how modern clinical trial methods could evolve and benefit from Blockchain technologies in order to tackle the aforementioned challenges.

  19. Reengineering Clinical Research Science: A Focus on Translational Research

    Science.gov (United States)

    Ferrell, Courtney B.

    2009-01-01

    The burden of disease in the United States is high. Mental illness is currently the leading cause of disease burden among 15- to 44-year-olds. This phenomenon is occurring despite the many advances that have been made in clinical research. Several efficacious interventions are available to treat many of these disorders; however, they are greatly…

  20. Research: Clinical undergraduate medical student training at ...

    African Journals Online (AJOL)

    To profile the clinicians at Kimberley Hospital Complex in terms of their knowledge of, skills in and perspectives on the added responsibility of clinical undergraduate medical student training prior to the launch of the proposed undergraduate student rotations. Methods. The study followed a qualitative research design using ...

  1. Guidelines for enhancing clinical supervision: research ...

    African Journals Online (AJOL)

    ... toesighouding behels, maar dat hulle nie die noodsaaklikheid om reflektiewe leer toe te pas tydens die proses van kliniese toesighouding aangedui het nie. Keywords: Clinical supervision, Reflective thinking and learning, Support, Guidance (Health SA Gesondheid: interdisciplinary research journal: 2003 8(4): 12-23) ...

  2. Vulnerability of pregnant women in clinical research

    NARCIS (Netherlands)

    van der Zande, Indira S. E.; van der Graaf, Rieke; Oudijk, Martijn A.; van Delden, Johannes J. M.

    2017-01-01

    Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as

  3. Students Discover Unique Planet

    Science.gov (United States)

    2008-12-01

    Three undergraduate students, from Leiden University in the Netherlands, have discovered an extrasolar planet. The extraordinary find, which turned up during their research project, is about five times as massive as Jupiter. This is also the first planet discovered orbiting a fast-rotating hot star. Omega Centauri ESO PR Photo 45a/08 A planet around a hot star The students were testing a method of investigating the light fluctuations of thousands of stars in the OGLE database in an automated way. The brightness of one of the stars was found to decrease for two hours every 2.5 days by about one percent. Follow-up observations, taken with ESO's Very Large Telescope in Chile, confirmed that this phenomenon is caused by a planet passing in front of the star, blocking part of the starlight at regular intervals. According to Ignas Snellen, supervisor of the research project, the discovery was a complete surprise. "The project was actually meant to teach the students how to develop search algorithms. But they did so well that there was time to test their algorithm on a so far unexplored database. At some point they came into my office and showed me this light curve. I was completely taken aback!" The students, Meta de Hoon, Remco van der Burg, and Francis Vuijsje, are very enthusiastic. "It is exciting not just to find a planet, but to find one as unusual as this one; it turns out to be the first planet discovered around a fast rotating star, and it's also the hottest star found with a planet," says Meta. "The computer needed more than a thousand hours to do all the calculations," continues Remco. The planet is given the prosaic name OGLE2-TR-L9b. "But amongst ourselves we call it ReMeFra-1, after Remco, Meta, and myself," says Francis. The planet was discovered by looking at the brightness variations of about 15 700 stars, which had been observed by the OGLE survey once or twice per night for about four years between 1997 and 2000. Because the data had been made public

  4. China makes an impressive breakthrough in avian influenza virus research - Discovering the "heart" of avian infl uenza virus.

    Science.gov (United States)

    Li, Y G; Wu, J F; Li, X

    2009-02-01

    The successive appearance of strains of epizootic avian influenza A virus with the subtype H5N1 in China has attracted considerable concern from the public and Chinese authorities. According to the latest WHO estimates as of February 2, 2009, the number of H5N1 virus deaths in China totaled 25, second only to Indonesia and Viet Nam (http://www.who.int/csr/disease/avian_influenza/country/cases_table_2009_02_02/en/index.html). The H5N1 virus is highly contagious among birds and is fatal when transmitted to humans, though the means by which this occurs is still unknown. Owing to the possible variation of the H5N1 prototype virus, together with the fact that it has the propensity to exchange genes with influenza viruses from other species, humans have no natural immunity to the virus. Despite years of efforts, the exact pathogenesis of H5N1 transmission to humans is still not completely clear, nor is potential human-tohuman transmission as could lead to an epidemic or even worldwide pandemic (Enserink M. Science. 2009; 323:324). Unfortunately, current antiviral treatment and therapeutic measures cannot effectively overcome this virulent virus that causes highly pathogenic avian influenza (HPAI). Researchers from around the world are working to study the virology of influenza viruses, including their methods of infiltration, replication, and transcription, to elucidate the mechanisms of unremitting viral infection in terms of aspects such as the virus, host, and environment. These researchers are also working to identify potential molecular targets related to H5N1 for anti-influenza drug intervention. A recent H5N1-related study from China provides encouraging information. According to the People's Daily (Renmin Ribao), a newspaper out of Beijing, professor Liu Yingfang, academician Rao Zihe, and fellow researchers from more than 6 research centers, including the Institute of Biophysics Chinese Academy of Sciences, Nankai University, and Tsinghua University, have

  5. Maintenance of Clinical Expertise and Clinical Research by the Clinical Professors at Gifu Pharmaceutical University.

    Science.gov (United States)

    Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi

    2017-01-01

    The clinical professors at Gifu Pharmaceutical University (GPU) provide pharmaceutical services at GPU Pharmacy, Gifu University Hospital, and Gifu Municipal Hospital to keep their clinical skills up-to-date; they also perform clinical research in collaboration with many clinical institutes. The Laboratory of Clinical Pharmacy is part of the Department of Pharmacy Practice and Science, to which the clinical professors belong, and is composed of three clinical professors (a professor, an associate professor, and an assistant professor). The professor administers the GPU Pharmacy as its director, while the associate professor and assistant professor provide pharmaceutical services to patients at Gifu Municipal Hospital, and also provide practical training for students in the GPU Pharmacy. Collectively, they have performed research on such topics as medication education for students, clinical communication education, and analysis of clinical big data. They have also conducted research in collaboration with clinical institutes, hospitals, and pharmacies. Here, we introduce the collaborative research between the Laboratory of Clinical Pharmacy and Gifu Municipal Hospital. These studies include "Risk factors contributing to urinary protein expression resulting from bevacizumab combination chemotherapy", "Hyponatremia and hypokalemia as risk factors for falls", "Economic evaluation of adjustments of levofloxacin dosage by dispensing pharmacists for patients with renal dysfunction", and "Effect of patient education upon discharge for use of a medication notebook on purchasing over-the-counter drugs and health foods". In this symposium, we would like to demonstrate one model of the association and collaborative research between these clinical professors and clinical institutes.

  6. Making smart investment decisions in clinical research.

    Science.gov (United States)

    Bansback, Nick; Keystone, Edward; O'Dell, James; Phibbs, Ciaran S; Hannagan, Keri; Brophy, Mary; Anis, Aslam

    2015-12-29

    A recent trial in rheumatoid arthritis found an inexpensive, but infrequently used, combination of therapies is neither inferior nor less safe than an expensive biologic drug. If the trial had been conducted over 10 years ago, arguably 100's of millions of dollars since spent on biologics could have been released to other, more effective treatments. Given the ever increasing number of trials proposed, this commentary uses the trial as an example to challenge payers and research funders to make smarter investments in clinical research to save potential future costs. NCT00405275 , registered 29 November 2006.

  7. Bringing ayahuasca to the clinical research laboratory.

    Science.gov (United States)

    Riba, Jordi; Barbanoj, Manel J

    2005-06-01

    Since the winter of 1999, the authors and their research team have been conducting clinical studies involving the administration of ayahuasca to healthy volunteers. The rationale for conducting this kind of research is twofold. First, the growing interest of many individuals for traditional indigenous practices involving the ingestion of natural psychotropic drugs such as ayahuasca demands the systematic study of their pharmacological profiles in the target species, i.e., human beings. The complex nature of ayahuasca brews combining a large number of pharmacologically active compounds requires that research be carried out to establish the safety and overall pharmacological profile of these products. Second, the authors believe that the study of psychedelics in general calls for renewed attention. Although the molecular and electrophysiological level effects of these drugs are relatively well characterized, current knowledge of the mechanisms by which these compounds modify the higher order cognitive processes in the way they do is still incomplete, to say the least. The present article describes the development of the research effort carried out at the Autonomous University of Barcelona, commenting on several methodological aspects and reviewing the basic clinical findings. It also describes the research currently underway in our laboratory, and briefly comments on two new studies we plan to undertake in order to further our knowledge of the pharmacology of ayahuasca.

  8. Periprosthetic Joint Infections: Clinical and Bench Research

    Directory of Open Access Journals (Sweden)

    Laurence Legout

    2013-01-01

    Full Text Available Prosthetic joint infection is a devastating complication with high morbidity and substantial cost. The incidence is low but probably underestimated. Despite a significant basic and clinical research in this field, many questions concerning the definition of prosthetic infection as well the diagnosis and the management of these infections remained unanswered. We review the current literature about the new diagnostic methods, the management and the prevention of prosthetic joint infections.

  9. Current clinical research in orthodontics: a perspective.

    Science.gov (United States)

    Baumrind, Sheldon

    2006-10-01

    This essay explores briefly the approach of the Craniofacial Research Instrumentation Laboratory to the systematic and rigorous investigation of the usual outcome of orthodontic treatment in the practices of experienced clinicians. CRIL's goal is to produce a shareable electronic database of reliable, valid, and representative data on clinical practice as an aid in the production of an improved environment for truly evidence-based orthodontic treatment.

  10. Negotiation skills for clinical research professionals

    Directory of Open Access Journals (Sweden)

    Sanjay Hake

    2011-01-01

    Full Text Available Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors.

  11. Negotiation skills for clinical research professionals

    Science.gov (United States)

    Hake, Sanjay; Shah, Tapankumar

    2011-01-01

    Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors. PMID:21897886

  12. The Ontology of Clinical Research (OCRe): an informatics foundation for the science of clinical research.

    Science.gov (United States)

    Sim, Ida; Tu, Samson W; Carini, Simona; Lehmann, Harold P; Pollock, Brad H; Peleg, Mor; Wittkowski, Knut M

    2014-12-01

    To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes - the science of clinical research - are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe's modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study's scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Sampling Methods in Clinical Research; an Educational Review

    OpenAIRE

    Mohamed Elfil; Ahmed Negida

    2017-01-01

    Clinical research usually involves patients with a certain disease or a condition. The generalizability of clinical research findings is based on multiple factors related to the internal and external validity of the research methods. The main methodological issue that influences the generalizability of clinical research findings is the sampling method. In this educational article, we are explaining the different sampling methods in clinical research.

  14. Clinical Research Informatics: Supporting the Research Study Lifecycle.

    Science.gov (United States)

    Johnson, S B

    2017-08-01

    Objectives: The primary goal of this review is to summarize significant developments in the field of Clinical Research Informatics (CRI) over the years 2015-2016. The secondary goal is to contribute to a deeper understanding of CRI as a field, through the development of a strategy for searching and classifying CRI publications. Methods: A search strategy was developed to query the PubMed database, using medical subject headings to both select and exclude articles, and filtering publications by date and other characteristics. A manual review classified publications using stages in the "research study lifecycle", with key stages that include study definition, participant enrollment, data management, data analysis, and results dissemination. Results: The search strategy generated 510 publications. The manual classification identified 125 publications as relevant to CRI, which were classified into seven different stages of the research lifecycle, and one additional class that pertained to multiple stages, referring to general infrastructure or standards. Important cross-cutting themes included new applications of electronic media (Internet, social media, mobile devices), standardization of data and procedures, and increased automation through the use of data mining and big data methods. Conclusions: The review revealed increased interest and support for CRI in large-scale projects across institutions, regionally, nationally, and internationally. A search strategy based on medical subject headings can find many relevant papers, but a large number of non-relevant papers need to be detected using text words which pertain to closely related fields such as computational statistics and clinical informatics. The research lifecycle was useful as a classification scheme by highlighting the relevance to the users of clinical research informatics solutions. Georg Thieme Verlag KG Stuttgart.

  15. Interpretation of correlations in clinical research.

    Science.gov (United States)

    Hung, Man; Bounsanga, Jerry; Voss, Maren Wright

    2017-11-01

    Critically analyzing research is a key skill in evidence-based practice and requires knowledge of research methods, results interpretation, and applications, all of which rely on a foundation based in statistics. Evidence-based practice makes high demands on trained medical professionals to interpret an ever-expanding array of research evidence. As clinical training emphasizes medical care rather than statistics, it is useful to review the basics of statistical methods and what they mean for interpreting clinical studies. We reviewed the basic concepts of correlational associations, violations of normality, unobserved variable bias, sample size, and alpha inflation. The foundations of causal inference were discussed and sound statistical analyses were examined. We discuss four ways in which correlational analysis is misused, including causal inference overreach, over-reliance on significance, alpha inflation, and sample size bias. Recent published studies in the medical field provide evidence of causal assertion overreach drawn from correlational findings. The findings present a primer on the assumptions and nature of correlational methods of analysis and urge clinicians to exercise appropriate caution as they critically analyze the evidence before them and evaluate evidence that supports practice. Critically analyzing new evidence requires statistical knowledge in addition to clinical knowledge. Studies can overstate relationships, expressing causal assertions when only correlational evidence is available. Failure to account for the effect of sample size in the analyses tends to overstate the importance of predictive variables. It is important not to overemphasize the statistical significance without consideration of effect size and whether differences could be considered clinically meaningful.

  16. Discovering potential clinical profiles of multiple sclerosis from clinical and pathological free text data with constrained non-negative matrix factorization

    NARCIS (Netherlands)

    Acquarelli, Jacopo; Bianchini, Monica; Marchiori, Elena

    2016-01-01

    Constrained non-negative matrix factorization (CNMF) is an effective machine learning technique to cluster documents in the presence of class label constraints. In this work, we provide a novel application of this technique in research on neuro-degenerative diseases. Specifically, we consider a

  17. Is phosphoproteomics ready for clinical research?

    Science.gov (United States)

    Iliuk, Anton B; Tao, W Andy

    2013-05-01

    For many diseases such as cancer where phosphorylation-dependent signaling is the foundation of disease onset and progression, single-gene testing and genomic profiling alone are not sufficient in providing most critical information. The reason for this is that in these activated pathways the signaling changes and drug resistance are often not directly correlated with changes in protein expression levels. In order to obtain the essential information needed to evaluate pathway activation or the effects of certain drugs and therapies on the molecular level, the analysis of changes in protein phosphorylation is critical. Existing approaches do not differentiate clinical disease subtypes on the protein and signaling pathway level, and therefore hamper the predictive management of the disease and the selection of therapeutic targets. The mini-review examines the impact of emerging systems biology tools and the possibility of applying phosphoproteomics to clinical research. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories.

    Science.gov (United States)

    Ezzelle, J; Rodriguez-Chavez, I R; Darden, J M; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, M P

    2008-01-07

    A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting.

  19. Frequent methodological errors in clinical research.

    Science.gov (United States)

    Silva Aycaguer, L C

    2018-03-07

    Several errors that are frequently present in clinical research are listed, discussed and illustrated. A distinction is made between what can be considered an "error" arising from ignorance or neglect, from what stems from a lack of integrity of researchers, although it is recognized and documented that it is not easy to establish when we are in a case and when in another. The work does not intend to make an exhaustive inventory of such problems, but focuses on those that, while frequent, are usually less evident or less marked in the various lists that have been published with this type of problems. It has been a decision to develop in detail the examples that illustrate the problems identified, instead of making a list of errors accompanied by an epidermal description of their characteristics. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

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

    Science.gov (United States)

    Daniel, C; Choquet, R

    2013-01-01

    To summarize advances of excellent current research in the new emerging field of Clinical Research Informatics. Synopsis of four key articles selected for the IMIA Yearbook 2013. The selection was performed by querying PubMed and Web of Science with predefined keywords. From the original set of 590 papers, a first subset of 461 articles which was in the scope of Clinical Research Informatics was refined into a second subset of 79 relevant articles from which 15 articles were retained for peer-review. The four selected articles exemplify current research efforts conducted in the areas of data representation and management in clinical trials, secondary use of EHR data for clinical research, information technology platforms for translational and comparative effectiveness research and implementation of privacy control. The selected articles not only illustrate how innovative information technology supports classically organized randomized controlled trials but also demonstrate that the long promised benefits of electronic health care data for research are becoming a reality through concrete platforms and projects.

  1. How to Conduct Clinical Qualitative Research on the Patient's Experience

    Science.gov (United States)

    Chenail, Ronald J.

    2011-01-01

    From a perspective of patient-centered healthcare, exploring patients' (a) preconceptions, (b) treatment experiences, (c) quality of life, (d) satisfaction, (e) illness understandings, and (f) design are all critical components in improving primary health care and research. Utilizing qualitative approaches to discover patients' experiences can…

  2. Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials

    OpenAIRE

    Noriko Fujiwara; Ryota Ochiai; Yuki Shirai; Yuko Saito; Fumitaka Nagamura; Satoru Iwase; Keiko Kazuma

    2017-01-01

    Background: Clinical research coordinators play a pivotal role in phase I cancer clinical trials. Purpose: We clarified the care coordination and practice for patients provided by clinical research coordinators in phase I cancer clinical trials in Japan and elucidated clinical research coordinators' perspective on patients' expectations and understanding of these trials. Method: Fifteen clinical research coordinators participated in semi-structured interviews regarding clinical practice...

  3. The Brave New World of clinical cancer research: Adaptive biomarker-driven trials integrating clinical practice with clinical research.

    Science.gov (United States)

    Berry, Donald A

    2015-05-01

    Clinical trials are the final links in the chains of knowledge and for determining the roles of therapeutic advances. Unfortunately, in an important sense they are the weakest links. This article describes two designs that are being explored today: platform trials and basket trials. Both are attempting to merge clinical research and clinical practice. Copyright © 2015 Federation of European Biochemical Societies. Published by Elsevier B.V. All rights reserved.

  4. Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators.

    Science.gov (United States)

    Jones, Carolynn Thomas; Hastings, Clare; Wilson, Lynda Law

    2015-01-01

    There has been limited research to document differences in roles between nurses and non-nurses who assume clinical research coordination and management roles. Several authors have suggested that there is no acknowledged guidance for the licensure requirements for research study coordinators and that some non-nurse research coordinators may be assuming roles that are outside of their legal scopes of practice. There is a need for further research on issues related to the delegation of clinical research activities to non-nurses. This study used nominal group process focus groups to identify perceptions of experienced research nurse managers at an academic health science center in the Southern United States about the clinical research activities that are being performed by non-nurse clinical research coordinators without supervision that they believed should only be performed by a nurse or under the supervision of a nurse. A total of 13 research nurse managers volunteered to be contacted about the study. Of those, 8 participated in two separate nominal group process focus group sessions. The group members initially identified 22 activities that they felt should only be performed by a nurse or under the direct supervision of a nurse. After discussion and clarification of results, activities were combined into 12 categories of clinical research activities that participants believed should only be performed by a nurse or under the direct supervision of a nurse. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Laser microdissection in translational and clinical research.

    Science.gov (United States)

    Ladanyi, Andras; Sipos, Ferenc; Szoke, Dominika; Galamb, Orsolya; Molnar, Bela; Tulassay, Zsolt

    2006-09-01

    Laser microdissection (LMD) is now a well established method for isolating individual cells or subcellular structures from a heterogeneous cell population. In recent years, cell, DNA, RNA, and protein based techniques has been successfully coupled to LMD and important information has been gathered through the analysis of the genome, transcriptome, and more recently the proteome of individual microdissected cells. The aims of this review are to summarize and compare the principles of different laser microdissection instruments and techniques, to discuss sample preparation procedures for microdissection, and to provide wide variety of examples of translational/clinical research applications of LMD. Novel techniques specifically developed for the improved isolation of stained cells, living cells, or rare cells are also discussed.LMD has become an indispensable tool in the preparation of homogenous samples for sophisticated cell or molecular assays. Despite major technological advances, the labor requirements of LMD are still relatively high. However, understanding the advantages and disadvantages of LMD technology and associated sample preparation procedures may aid in the earlier introduction of this method into the routine clinical diagnostics. (c) 2006 International Society for Analytical Cytology.

  6. Metapsychological and clinical issues in psychosomatics research.

    Science.gov (United States)

    Press, Jacques

    2016-02-01

    The author starts by treating the general epistemological problems inherent to research and emphasizes that all investigation takes place between two poles: a creative pole and one that is defensive in relation to the unknown and formlessness. In the psychosomatic field, an additional difficulty resides in the western dualistic vision of the relationship between psyche and soma which influences our way of thinking about the body as well as about otherness. The author continues by exploring Pierre Marty's psychosomatic model. Its psychosomatic monism is revolutionary but incomplete and creates a distance with the other, the somatizing patient, resulting in a medically oriented nosology symptomatic of the impossibility to think about some of the most important aspects of counter-transference. With the help of clinical material, the author considers these unthought aspects and some of their theoretical implications, particularly the way of understanding the negative often so prevalent with these patients. Based on these reflections as well as Freud's on beyond the pleasure principle and Winnicott's theorization on the fear of breakdown, the author suggests some directions for research. Somatic illness might occur when the attempts at filling the cracks created by a breakdown are unsuccessful. Copyright © 2015 Institute of Psychoanalysis.

  7. Recent gains in clinical multiple sclerosis research.

    Science.gov (United States)

    Runia, T F; van Pelt-Gravesteijn, E D; Hintzen, R Q

    2012-08-01

    Multiple sclerosis (MS) is a common neurological disease mainly affecting young people. Around the world, over 2.5 million people suffer from this central nervous system (CNS) disorder. Although the exact disease mechanism is not completely clear, it is known that both environmental and genetic factors influence the development of MS. Here we aim to summarize a few major highlights of recent progress that have been made in clinical MS research. A genetic predisposition in combination with Epstein-Barr virus infection seems to be essential to get MS. Recently more than 50 susceptibility genetic loci for MS have been described. MS prevalence has a latitudinal gradient indicating that sunlight exposure and therefore vitamin D are important contributors to MS risk. Several studies found an inverse association between MS prevalence and serum vitamin D levels. In most cases, MS starts with an acute episode involving one or more sites of the CNS. The role of the recently revised McDonald Diagnostic Criteria for the diagnosis of MS, which sometimes allow the diagnosis after a first attack, is discussed. Most patients with MS suffer from exacerbations and remissions of neurological deficits: relapsing-and remitting MS. With time, the majority of these patients enter a disease phase characterized by continuous, irreversible neurological decline; this is called secondary progressive MS. In 10-20% of patients, the disease is progressive from onset. Life expectancy of patients after diagnosis with MS is around 35 years, and MS patients die 5-10 years earlier than the general population. A substantial percentage of MS patients have their first attack during childhood. Clinics of childhood-onset MS versus adult-onset are explained, as are diagnostics, differential diagnoses and therapeutic options for children with MS. Also another demyelinating disease of the CNS, neuromyelitis optica (NMO) is highlighted. Since NMO has been considered as a variant of MS and also has been

  8. How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

    Science.gov (United States)

    Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

    2017-09-18

    Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive

  9. Clinical Trials: A Crucial Key to Human Health Research

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research Past ... the forefront of human health research today are clinical trials—studies that use human volunteers to help medical ...

  10. Children's self reported discomforts as participants in clinical research.

    NARCIS (Netherlands)

    Staphorst, M.S.; Hunfeld, J.A.M.; van de Vathorst, S.; Passchier, J.; van Goudoever, J.B.

    2015-01-01

    Introduction: There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to guide their decision-making on discomforts for children in clinical research. To get

  11. [Support Team for Investigator-Initiated Clinical Research].

    Science.gov (United States)

    Fujii, Hisako

    2017-07-01

    Investigator-initiated clinical research is that in which investigators plan and carry out their own clinical research in academia. For large-scale clinical research, a team should be organized and implemented. This team should include investigators and supporting staff, who will promote smooth research performance by fulfilling their respective roles. The supporting staff should include project managers, administrative personnel, billing personnel, data managers, and clinical research coordinators. In this article, I will present the current status of clinical research support and introduce the research organization of the Dominantly Inherited Alzheimer Network (DIAN) study, an investigator-initiated international clinical research study, with particular emphasis on the role of the project management staff and clinical research coordinators.

  12. [Source data management in clinical researches].

    Science.gov (United States)

    Ho, Effie; Yao, Chen; Zhang, Zi-bao; Liu, Yu-xiu

    2015-11-01

    Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.

  13. Infant intersubjectivity: research, theory, and clinical applications.

    Science.gov (United States)

    Trevarthen, C; Aitken, K J

    2001-01-01

    We review research evidence on the emergence and development of active "self-and-other" awareness in infancy, and examine the importance of its motives and emotions to mental health practice with children. This relates to how communication begins and develops in infancy, how it influences the individual subject's movement, perception, and learning, and how the infant's biologically grounded self-regulation of internal state and self-conscious purposefulness is sustained through active engagement with sympathetic others. Mutual self-other-consciousness is found to play the lead role in developing a child's cooperative intelligence for cultural learning and language. A variety of preconceptions have animated rival research traditions investigating infant communication and cognition. We distinguish the concept of "intersubjectivity", and outline the history of its use in developmental research. The transforming body and brain of a human individual grows in active engagement with an environment of human factors--organic at first, then psychological or inter-mental. Adaptive, human-responsive processes are generated first by interneuronal activity within the developing brain as formation of the human embryo is regulated in a support-system of maternal tissues. Neural structures are further elaborated with the benefit of intra-uterine stimuli in the foetus, then supported in the rapidly growing forebrain and cerebellum of the young child by experience of the intuitive responses of parents and other human companions. We focus particularly on intrinsic patterns and processes in pre-natal and post-natal brain maturation that anticipate psychosocial support in infancy. The operation of an intrinsic motive formation (IMF) that developed in the core of the brain before birth is evident in the tightly integrated intermodal sensory-motor coordination of a newborn infant's orienting to stimuli and preferential learning of human signals, by the temporal coherence and intrinsic

  14. Decline of clinical research in academic medical centers.

    Science.gov (United States)

    Meador, Kimford J

    2015-09-29

    Marked changes in US medical school funding began in the 1960s with progressively increasing revenues from clinical services. The growth of clinical revenues slowed in the mid-1990s, creating a funding crisis for US academic health care centers, who responded by having their faculty increase their clinical duties at the expense of research activities. Surveys document the resultant stresses on the academic clinician researcher. The NIH provides greater funding for basic and translational research than for clinical research, and the new Patient-Centered Outcomes Research Institute is inadequately funded to address the scope of needed clinical research. An increasing portion of clinical research is funded by industry, which leaves many important clinical issues unaddressed. There is an inadequate supply of skilled clinical researchers and a lack of external support for clinical research. The impact on the academic environment in university medical centers is especially severe on young faculty, who have a shrinking potential to achieve successful academic careers. National health care research funding policies should encourage the right balance of life-science investigations. Medical universities need to improve and highlight education on clinical research for students, residents, fellows, and young faculty. Medical universities also need to provide appropriate incentives for clinical research. Without training to ensure an adequate supply of skilled clinical researchers and a method to adequately fund clinical research, discoveries from basic and translational research cannot be clinically tested and affect patient care. Thus, many clinical problems will continue to be evaluated and treated with inadequate or even absent evidence-based knowledge. © 2015 American Academy of Neurology.

  15. Binge eating disorder: from clinical research to clinical practice.

    Science.gov (United States)

    Goracci, Arianna; Casamassima, Francesco; Iovieno, Nadia; di Volo, Silvia; Benbow, Jim; Bolognesi, Simone; Fagiolini, Andrea

    2015-01-01

    This case report describes the clinical course of a young woman suffering from binge eating disorder (BED) associated with obesity. It illustrates the efficacy of different medications in the treatment of BED and related conditions and is followed by the comments and clinical observations of 2 practicing psychiatrists. The issues described in this paper have important clinical implications and are topical, given that BED is now recognized as a specific disorder in the new Diagnostic and Statistical Manual of Mental Disorders, fifth edition classification system, but neither the US Food and Drug Administration nor any other regulatory agency has yet approved a drug for treatment of this disease, despite its very prevalent and disabling nature. Growing evidence from the fields of psychopathology and neurobiology, including preclinical and clinical studies, converges to support the idea that "overeating" has much in common with other behavioral addictions, and substance abuse treatment agents may show promise for the treatment of BED.

  16. Be a Partner in Clinical Research

    Science.gov (United States)

    ... additional medical care and attention offered by clinical trial staff. But many participants also say they volunteer to benefit others. “This will be my chance to give back and help other people, ... NIH clinical trial volunteer who was battling cancer. Our medical care ...

  17. Chandra Discovers Cosmic Cannonball

    Science.gov (United States)

    2007-11-01

    thought to have been ejected by interactions with the supermassive black hole in the Galaxy's center. CTIO Optical Images of Puppis A CTIO Optical Images of Puppis A This neutron star, by contrast, was flung into motion by the supernova that created Puppis A. The data suggest the explosion was lop-sided, kicking the neutron star in one direction and the debris from the explosion in the other. The supernova was precipitated when the core of a massive star imploded to form a neutron star. Computer simulations show that the infall of the outer layers of the star onto a neutron star releases an enormous amount of energy. As this energy propagates outward, it can reverse the infall and eject the outer layers of the star at speeds of millions of miles per hour. Due to the complexity of the flow, the ejection is not symmetric, leading to a rocket effect that propels the neutron star in the opposite direction. ROSAT X-ray ROSAT X-ray The breakneck speed of the Puppis A neutron star, plus an apparent lack of pulsations from it, is not easily explained by even the most sophisticated supernova explosion models. "The problem with discovering this cosmic cannonball is we aren't sure how to make the cannon powerful enough." said Winkler. "The high speed might be explained by an unusually energetic explosion, but the models are complicated and hard to apply to real explosions." Other recent work on RX J0822-4300 was published by C.Y. Hui and Wolfgang Becker, both from the Max Planck Institute for Extraterrestrial Physics in Munich, in the journal Astronomy and Astrophysics in late 2006. Using two of the three Chandra observations reported in the Winkler paper and a different analysis technique, the Hui group found a speed for RX J0822-4300 that is about two-thirds as fast, but with larger reported margins of error. The research by Winkler and Petre was published in the November 20 issue of The Astrophysical Journal. NASA's Marshall Space Flight Center, Huntsville, Ala., manages the

  18. Lightest exoplanet yet discovered

    Science.gov (United States)

    2009-04-01

    Well-known exoplanet researcher Michel Mayor today announced the discovery of the lightest exoplanet found so far. The planet, "e", in the famous system Gliese 581, is only about twice the mass of our Earth. The team also refined the orbit of the planet Gliese 581 d, first discovered in 2007, placing it well within the habitable zone, where liquid water oceans could exist. These amazing discoveries are the outcome of more than four years of observations using the most successful low-mass-exoplanet hunter in the world, the HARPS spectrograph attached to the 3.6-metre ESO telescope at La Silla, Chile. ESO PR Photo 15a/09 Artist's impression of Gliese 581 e ESO PR Photo 15b/09 A planet in the habitable zone ESO PR Video 15a/09 ESOcast 6 ESO PR Video 15b/09 VNR A-roll ESO PR Video 15c/09 Zoom-in on Gliese 581 e ESO PR Video 15d/09 Artist's impression of Gliese 581 e ESO PR Video 15e/09 Artist's impression of Gliese 581 d ESO PR Video 15f/09 Artist's impression of Gliese 581 system ESO PR Video 15g/09 The radial velocity method ESO PR Video 15h/09 Statement in English ESO PR Video 15i/09 Statement in French ESO PR Video 15j/09 La Silla Observatory "The holy grail of current exoplanet research is the detection of a rocky, Earth-like planet in the ‘habitable zone' -- a region around the host star with the right conditions for water to be liquid on a planet's surface", says Michel Mayor from the Geneva Observatory, who led the European team to this stunning breakthrough. Planet Gliese 581 e orbits its host star - located only 20.5 light-years away in the constellation Libra ("the Scales") -- in just 3.15 days. "With only 1.9 Earth-masses, it is the least massive exoplanet ever detected and is, very likely, a rocky planet", says co-author Xavier Bonfils from Grenoble Observatory. Being so close to its host star, the planet is not in the habitable zone. But another planet in this system appears to be. From previous observations -- also obtained with the HARPS spectrograph

  19. Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies

    Science.gov (United States)

    2016-10-01

    a multi-institutional infrastructure incorporating 5 leading prostate cancer clinical sites, 2 sequencing and computational analysis sites, linked...unacceptable toxicity. Radiological assesment were defined according PCWG2 criteria and RECIST 1.1. Results: 64 pts were identified, 47 met all criteria

  20. Clinical research training of Peruvian neurologists: a baseline assessment

    Directory of Open Access Journals (Sweden)

    Joseph Raymond Zunt

    2010-06-01

    Full Text Available In Peru, despite a strong clinical research infrastructure in Lima, and Masters degree programs in epidemiology at three universities, few neurologists participate in clinical research. It was our objective to identify perceived needs and opportunities for increasing clinical research capacity and training opportunities for Peruvian neurologists. We conducted a descriptive, cross-sectional survey of Peruvian neurologists in Lima and Arequipa, Peru. Forty-eight neurologists completed written surveys and oral interviews. All neurologists reported interest in clinical research, but noted that lack of time and financial resources limited their ability to participate. Although most neurologists had received some training in epidemiology and research design as medical students or residents, the majority felt these topics were not adequately covered. Neurologists in Arequipa noted international funding for clinical research was uncommon outside the capital city of Lima. We concluded that clinical research is important to Peruvian neurologists. The three main barriers to increased participation in clinical research identified by neurologists were insufficient training in clinical research methodology, meager funding opportunities, and lack of dedicated time to participate in clinical research. Distance learning holds promise as a method for providing additional training in clinical research methodology, especially for neurologists who may have difficulty traveling to larger cities for additional training.

  1. 76 FR 66367 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-10-26

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research....... The Sheraton Crystal City. Oncology December 8-9, 2011.. The Sheraton Crystal City. Clinical Research...

  2. Cultural humility: essential foundation for clinical researchers.

    Science.gov (United States)

    Yeager, Katherine A; Bauer-Wu, Susan

    2013-11-01

    Cultural humility is a process of self-reflection and discovery in order to build honest and trustworthy relationships. It offers promise for researchers to understand and eliminate health disparities, a continual and disturbing problem necessitating attention and action on many levels. This paper presents a discussion of the process of cultural humility and its important role in research to better understand the perspectives and context of the researcher and the research participant. We discern cultural humility from similar concepts, specifically cultural competence and reflexivity. We will also explore ways to cultivate cultural humility in the context of human subjects research. Mindfulness is one approach that can be helpful in enhancing awareness of self and others in this process. With a foundation in cultural humility, nurse researchers and other investigators can implement meaningful and ethical projects to better address health disparities. © 2013.

  3. Barriers to Clinical Research in Latin America

    OpenAIRE

    Chomsky-Higgins, Kathryn; Miclau, Theodore A.; Mackechnie, Madeline C.; Aguilar, Dino; Avila, Jorge Rubio; dos Reis, Fernando Baldy; Balmaseda, Roberto; Barquet, Antonio; Ceballos, Alfredo; Contreras, Fernando; Escalante, Igor; Elias, Nelson; Vincenti, Sergio Iriarte; Lozano, Christian; Medina, Fryda

    2017-01-01

    Enhancing health research capacity in developing countries is a global health priority. Understanding the orthopedic burden of disease in Latin America will require close partnership between more-developed and less-developed countries. To this end, the Osteosynthesis and Trauma Care Foundation assembled a research consortium of Latin-American orthopedic leaders. Prior to the meeting, we surveyed attendees on perceived barriers to conducting research at their institutions. During the event, wo...

  4. Highly effective cystic fibrosis clinical research teams: critical success factors.

    Science.gov (United States)

    Retsch-Bogart, George Z; Van Dalfsen, Jill M; Marshall, Bruce C; George, Cynthia; Pilewski, Joseph M; Nelson, Eugene C; Goss, Christopher H; Ramsey, Bonnie W

    2014-08-01

    Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study. To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success. Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams. CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network. Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research. Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research. Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.

  5. RESEARCH Voluntary informed consent and good clinical practice ...

    African Journals Online (AJOL)

    Voluntary informed consent for participation in clinical research is the cornerstone of health research ethics and a requirement for clinical research in South Africa. The South African-specific guidance documents concerning voluntary informed consent provisions differ and sometimes contradict international documents.

  6. Conducting research in clinical psychology practice: Barriers, facilitators, and recommendations.

    Science.gov (United States)

    Smith, Kirsten V; Thew, Graham R

    2017-09-01

    The combination of clinical psychologists' therapeutic expertise and research training means that they are in an ideal position to be conducting high-quality research projects. However, despite these skills and the documented benefits of research to services and service users, research activity in practice remains low. This article aims to give an overview of the advantages of, and difficulties in conducting research in clinical practice. We reviewed the relevant literature on barriers to research and reflected on our clinical and research experiences in a range of contexts to offer practical recommendations. We considered factors involved in the planning, sourcing support, implementation, and dissemination phases of research, and outline suggestions to improve the feasibility of research projects in post-qualification roles. We suggest that research leadership is particularly important within clinical psychology to ensure the profession's continued visibility and influence within health settings. Clinical implications Emerging evidence suggests that clinical settings that foster research are associated with better patient outcomes. Suggestions to increase the feasibility of research projects in clinical settings are detailed. Limitations The present recommendations are drawn from the authors' practical experience and may need adaptation to individual practitioners' settings. This study does not attempt to assess the efficacy of the strategies suggested. © 2017 The Authors. British Journal of Clinical Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.

  7. Hypofractionated stereotactic irradiation. Basic and clinical researches

    International Nuclear Information System (INIS)

    Shibamoto, Yuta; Miyakawa, Akifumi; Iwata, Hiromitsu; Otsuka, Shinya; Ogino, Hiroyuki; Ayakawa, Shiho

    2011-01-01

    Hypofractionated stereotactic radiotherapy (SRT) has a number of biological advantages over single-session radiosurgery. An apparent trend is seen in the clinic towards shift from the latter to the former; however, there is no adequate model to convert single doses to hypofractionated doses. The linear-quadratic model overestimates the effect of single-fraction radiation. This should be kept in mind in evaluating the doses of stereotactic irradiation. ''Biological effective dose'' should not be used in radiosurgery and hypofractionated SRT. Clinically, we have used 3- to 10-fraction SRT for acoustic neuroma and benign skull base tumors using cyberknife and tomotherapy. Preliminary results are encouraging. (author)

  8. Ensuring rigour and trustworthiness of qualitative research in clinical pharmacy.

    Science.gov (United States)

    Hadi, Muhammad Abdul; José Closs, S

    2016-06-01

    The use of qualitative research methodology is well established for data generation within healthcare research generally and clinical pharmacy research specifically. In the past, qualitative research methodology has been criticized for lacking rigour, transparency, justification of data collection and analysis methods being used, and hence the integrity of findings. Demonstrating rigour in qualitative studies is essential so that the research findings have the "integrity" to make an impact on practice, policy or both. Unlike other healthcare disciplines, the issue of "quality" of qualitative research has not been discussed much in the clinical pharmacy discipline. The aim of this paper is to highlight the importance of rigour in qualitative research, present different philosophical standpoints on the issue of quality in qualitative research and to discuss briefly strategies to ensure rigour in qualitative research. Finally, a mini review of recent research is presented to illustrate the strategies reported by clinical pharmacy researchers to ensure rigour in their qualitative research studies.

  9. Research Training in the Biomedical, Behavioral, and Clinical Research Sciences

    Science.gov (United States)

    National Academies Press, 2011

    2011-01-01

    Comprehensive research and a highly-trained workforce are essential for the improvement of health and health care both nationally and internationally. During the past 40 years the National Research Services Award (NRSA) Program has played a large role in training the workforce responsible for dramatic advances in the understanding of various…

  10. International Partnerships for Clinical Cancer Research

    Science.gov (United States)

    CGH co-sponsors the 2015 International Symposium on Cancer Clinical Trials and related meetings held in partnership with the Japanese National Cancer Center (JNCC) and Embassies of France, Korea, United Kingdom (UK), and United States (US) in Tokyo on May 14 - 15, 2015.

  11. Clinical research training of Peruvian neurologists: a baseline assessment

    OpenAIRE

    Joseph Raymond Zunt; Alberto Díaz-Vásquez; Silvia Margarita Montano-Torres; Gian Carlos Navarro-Chumbes

    2010-01-01

    In Peru, despite a strong clinical research infrastructure in Lima, and Masters degree programs in epidemiology at three universities, few neurologists participate in clinical research. It was our objective to identify perceived needs and opportunities for increasing clinical research capacity and training opportunities for Peruvian neurologists. We conducted a descriptive, cross-sectional survey of Peruvian neurologists in Lima and Arequipa, Peru. Forty-eight neurologists completed written s...

  12. Research-informed teaching: a clinical approach

    OpenAIRE

    Nicholson, Alex

    2017-01-01

    In a bid to attract students amidst increasing competition within the sector, many universities claim that their teaching is “research-informed”. However, there is some disagreement amongst academics about what actually counts as research-informed teaching and therefore how it should be developed and delivered. Furthermore, whilst academic reputation is a key factor for prospective university applicants, the primary\\ud objective of the majority is to enhance employability. Institutions must t...

  13. Research-active clinical nurses: against all odds.

    Science.gov (United States)

    Siedlecki, Sandra L; Albert, Nancy M

    2017-03-01

    To develop a theoretical understanding of factors that impact decisions of clinical nurses to conduct a research study. Only a small percentage of all nurses are research-active and even fewer clinical nurses are research-active. Several researchers have explored barriers to research activity by clinical nurses, but few have examined why, in spite of all odds, some clinical nurses are research-active. As the purpose of this study was to develop a theoretical understanding of the research-active nurse, a grounded theory approach was used. The sample interviewed for this study consisted of registered nurses (n = 26) who worked in a hospital or ambulatory setting, had daily direct patient contact and had participated as principal investigator on at least one completed clinical nursing research study that was not in fulfilment of an educational requirement. The interviews were digitally recorded and analysed by two researchers using the constant comparative method. The findings from this study suggest that the conduct of research by clinical nurses was the direct result of a clinical trigger, characteristics and beliefs of the nurse about research and their role in generating knowledge, and the presence of support conditions, such as a research mentor. Clinical nurses can and do conduct research, in spite of constraints due to a lack of time, money and/or knowledge, if they have access to research mentors and are practising in a research-supportive environment. Nurses at the bedside are in a unique position to identify problems most in need of solutions. Findings from this study provide a foundation upon which to develop and test various programmes that seek to increase the number of clinical nurses who are research-active. © 2016 John Wiley & Sons Ltd.

  14. Peer recommendations on how to improve clinical research, and Conference wrap-up.

    Science.gov (United States)

    Chad, David A; Rowland, Lewis P; Armon, Carmel; Bedlack, Richard; Durham, Heather; Factor-Litvak, Pam; Heiman-Patterson, Terry; Heitzman, Daragh; Lacomis, David; Ludolph, Albert; Maragakis, Nicholas; Miller, Robert; Pattee, Gary; Shoesmith, Christen; Sorenson, Eric; Turner, Martin R

    2013-05-01

    To promote clinical and patient oriented research, as part of the Second International ALS Conference in Tarrytown, NY, USA, seven pairs of clinicians and scientists were asked to lead discussions with meeting attendees on six major topics (one of which was discussed by two groups); each one the focus of a 90-min Breakout Session. Approximately 25 meeting attendees participated in each session. The Breakout Sessions considered six major themes: 1) Approaches to encourage clinicians to engage in more clinical research to discover the pathogenesis and cause of ALS; 2) Exploring avenues to build more effective partnerships between basic scientists and ALS physicians; 3) Increasing patient interest and commitment to participating in non-trial clinical research; 4) Brainstorming about factors that are most critical to the discovery of the pathogenesis and cause of ALS; 5) Finding ways to incorporate clinical research projects into clinical trials; and 6) Developing state-of-the-art epidemiological studies to solve the mystery of ALS. In this paper, we present the reports from each of the Breakout Sessions; and we provide a wrap-up of the entire conference.

  15. [An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

    Science.gov (United States)

    Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

    2015-06-01

    Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p research coordination and management" (p clinical practice.

  16. How to emerge from the conservatism in clinical research methodology?

    Science.gov (United States)

    Kotecki, Nuria; Penel, Nicolas; Awada, Ahmad

    2017-09-01

    Despite recent changes in clinical research methodology, many challenges remain in drug development methodology. Advances in molecular biology and cancer treatments have changed the clinical research landscape. Thus, we moved from empirical clinical oncology to molecular and immunological therapeutic approaches. Along with this move, adapted dose-limiting toxicities definitions, endpoints, and dose escalation methods have been proposed. Moreover, the classical frontier between phase I, phase II, and phase III has become unclear in particular for immunological approaches. So, investigators are facing major challenges in drug development methodology. We propose to individualize clinical research using innovative approaches to significantly improve patient outcomes and targeting what is considered unmet need. Integrating high level of translational research and performing well designed biomarker studies with great potential for clinical practice are of utmost importance. This could be performed within new models of clinical research networks and by building a strong collaboration between academic, cooperative groups, on-site investigators, and pharma.

  17. Importance of clinical epidemiology research in studies on respiratory diseases.

    Science.gov (United States)

    Iwanaga, Takashi; Tohda, Yuji

    2013-12-01

    Evidence-based medicine (EBM) has generated great interest since the 1990s and many physicians worldwide have based their clinical practice on this idea. Its underlying concepts include a diverse array of findings from clinical epidemiological research. In western countries, many clinical databases of clinical epidemiology are in circulation. Clinical epidemiological research using these data in western countries constitutes the majority worldwide. However, because race, lifestyle, culture, etc., differ among western countries and Japan, it is difficult to apply the results of clinical epidemiological research obtained in Japan to western countries. Unfortunately, there is no large-scale database for respiratory diseases prevalent in Japan. Many specialists agree with the opinion that it is necessary to collect medical information specific to the Japanese population and analyze the clinical data. KiHAC (Kinki Hokuriku Airway Disease Conference) was established in September 2001 with the aim of generating evidence through clinical epidemiological research for airway diseases by targeting physicians practicing respiratory medicine, pediatrics, and otorhinolaryngology, primarily in the Kinki and Hokuriku regions located in the central to western parts of Japan. As a part of the KiHAC, clinical research societies will attempt to cooperate with each other to make joint research possible and to share and utilize information, in addition to further promoting clinical research in the field of respiratory medicine. Copyright © 2013 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  18. Objectives | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The overall objective of CPTAC is to systematically identify proteins that derive from alterations in cancer genomes and related biological processes, in order to understand the molecular basis of cancer that is not fully elucidated or not possible through genomics and to accelerate the translation of molecular findings into the clinic.  This is to be achieved through enhancing our understanding of cancer genome biology by adding a complementary functional layer of protein biology (a “proteogenome” approach) that refines/prioritizes driver genes, enhances understanding of pathogenesis

  19. Guidelines for enhancing clinical supervision: research ...

    African Journals Online (AJOL)

    A qualitative, exploratory and descriptive research design was utilised where results from narrative sketches and literature control served as the basis for deducting and describing guidelines for enhancing reflection during the process of supervision. The conclusions drawn from the related findings are that the respondents ...

  20. Discovering evolution equations with applications

    CERN Document Server

    McKibben, Mark

    2011-01-01

    Most existing books on evolution equations tend either to cover a particular class of equations in too much depth for beginners or focus on a very specific research direction. Thus, the field can be daunting for newcomers to the field who need access to preliminary material and behind-the-scenes detail. Taking an applications-oriented, conversational approach, Discovering Evolution Equations with Applications: Volume 2-Stochastic Equations provides an introductory understanding of stochastic evolution equations. The text begins with hands-on introductions to the essentials of real and stochast

  1. Discovering Phonemes of Bidayuh

    Directory of Open Access Journals (Sweden)

    Jecky Misieng

    2012-07-01

    Full Text Available There are generally three views of the notion of a phoneme. The structuralist view of the phoneme focuses on this language phenomenon as a phonetic reality. In discovering phonemes of a language, phonologists who hold this view will look for minimal contrasting pairs as a way to determine contrasting sounds of that language. They will also look for allophones or two sounds of the same phoneme which may appear in complementary distribution. This paper will discuss the possible application of the structuralist approach to analyzing the phonemes of a dialect of Bidayuh, one of the Malayo-Polynesian languages spoken in the northern region of Borneo.

  2. Discovering system requirements

    Energy Technology Data Exchange (ETDEWEB)

    Bahill, A.T.; Bentz, B. [Univ. of Arizona, Tucson, AZ (United States). Systems and Industrial Engineering; Dean, F.F. [Sandia National Labs., Albuquerque, NM (United States)

    1996-07-01

    Cost and schedule overruns are often caused by poor requirements that are produced by people who do not understand the requirements process. This report provides a high-level overview of the system requirements process, explaining types, sources, and characteristics of good requirements. System requirements, however, are seldom stated by the customer. Therefore, this report shows ways to help you work with your customer to discover the system requirements. It also explains terminology commonly used in the requirements development field, such as verification, validation, technical performance measures, and the various design reviews.

  3. [Effect of data management quality on clinical research evidence evaluation].

    Science.gov (United States)

    Gao, Hong-yang; Li, Qing-na; Zhao, Yang; Li, Bo; Rui, Gao

    2015-02-01

    Current clinical evaluation of literature quality has various ways. Most of them lay special emphasis on the evaluation of the design quality, but the evaluation of the implementation process quality is not perfect. Especially data management is not fully emphasized during the enforcement of clinical trials. Data from clinical research were bases for evaluating clinical findings. Although strict specifications and requirements for data management might be strictly written clearly in research protocols, they were not embodied in current clinical research evidence evaluation system. Data management is an important part of implementing the whole clinical trial process, which is a comprehensive reflection of data collecting, logging, sorting, and managing. Its objective is to obtain high quality research data for statistical analysis, thereby coming to a true and reliable conclusion. In order to overall evaluating clinical design and implement, we suggest that present quality evaluation indicators of clinical trails should be completed, and add data management quality evaluation during the whole implement process. Data management plans, standards and requirements for data checking, and management regulations for disobeying data and exception data should be added in quality evaluation indicators for clinical research evidence. The effect of data management quality on clinical research evidence evaluation should be emphasized.

  4. Enrolling Minority and Underserved Populations in Cancer Clinical Research.

    Science.gov (United States)

    Wallington, Sherrie F; Dash, Chiranjeev; Sheppard, Vanessa B; Goode, Tawara D; Oppong, Bridget A; Dodson, Everett E; Hamilton, Rhonda N; Adams-Campbell, Lucile L

    2016-01-01

    Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials-a gold standard. Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. It is increasingly necessary to be aware of defining characteristics, such as location and culture of the populations from which research participants are enrolled. Little research has examined the effect of location and cultural competency in adapting clinical trial research for minority and underserved communities on accrual for clinical trials. Utilizing embedded community academic sites, the authors applied cultural competency frameworks to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials. This strategy resulted in successful accrual of participants to new clinical research trials, specifically targeting participation from minority and underserved communities in metropolitan Washington, DC. From 2012 to 2014, a total of 559 participants enrolled across six nontherapeutic clinical trials, representing a 62% increase in the enrollment of blacks in clinical research. Embedding cancer prevention programs and research in the community was shown to be yet another important strategy in the arsenal of approaches that can potentially enhance clinical research enrollment and capacity. The analyses showed that the capacity to acquire cultural knowledge about patients-their physical locales, cultural values, and environments in which they live-is essential to recruiting culturally and ethnically diverse population samples. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  5. Clinical research and medical care: towards effective and complete integration.

    Science.gov (United States)

    Sacristán, José A

    2015-01-09

    Despite their close relationship, clinical research and medical care have become separated by clear boundaries. The purpose of clinical research is to generate generalizable knowledge useful for future patients, whereas medical care aims to promote the well-being of individual patients. The evolution towards patient-centered medicine and patient-oriented research, and the gradual standardization of medicine are contributing to closer ties between clinical research and medical practice. But the integration of both activities requires addressing important ethical and methodological challenges. From an ethical perspective, clinical research should evolve from a position of paternalistic beneficence to a situation in which the principle of non-maleficence and patient autonomy predominate. The progressive adoption of "patient-oriented informed consent", "patient equipoise", and "altruism-based research", and the application of risk-based ethical oversight, in which the level of regulatory scrutiny is adapted to the potential risk for patients, are crucial steps to achieve the integration between research and care. From a methodological standpoint, careful and systematic observations should have greater relevance in clinical research, and experiments should be embedded into usual clinical practice. Clinical research should focus on individuals through the development of patient-oriented research. In a complementary way, the integration of experiments into medical practice through the systematic application of "point of care research" could help to generate knowledge for the individuals and for the populations. The integration of clinical research and medical care will require researchers, clinicians, health care managers, and patients to reevaluate the way they understand both activities. The development of an integrated learning health care system will contribute to generating and applying clinically relevant medical knowledge, producing benefits for present and future

  6. Clinical research progress of tuberculous meningitis

    Directory of Open Access Journals (Sweden)

    Zhan-yun MA

    2014-08-01

    Full Text Available Tuberculous meningitis is an infectious disease of central nervous system caused by Mycobacterium tuberculosis. It mainly invades into brain meninges and parenchyma, and may spread to the spinal cord and spinal meninges. The disability rate and mortality rate of this disease are very high. In recent years, incidence of tuberculosis increased significantly due to the increase of drug-resistant tuberculosis cases, population mobility, acquired immunodeficiency syndrome (AIDS epidemic and other factors. Tuberculosis is still a worldwide serious threat to human life and health, especially in the underdeveloped and developing countries. China is the world's largest developing country with large population, so tuberculosis prevention and control is still a quite severe problem. In this paper, the clinical manifestations, diagnosis and differential diagnosis, treatment progress of tuberculous meningitis were reviewed systematically. doi: 10.3969/j.issn.1672-6731.2014.08.004

  7. AIDS--Challenges to Basic and Clinical Biomedical Research.

    Science.gov (United States)

    Fauci, Anthony S.

    1989-01-01

    Clinical trials and access to therapeutic drugs pose dilemmas for researchers, physicians, and AIDS patients. The National Institute of Allergy and Infectious Diseases, recognizing the need for greater access to drugs by a broader spectrum of the infected population, is establishing the Community Programs for Clinical Research on AIDS. (Author/MLW)

  8. The Nephrology Clinical Research Nurse Role: Potential Role Conflicts.

    Science.gov (United States)

    Micklos, Lisa

    2016-01-01

    Clinical research nursing is becoming more visible to nephrology professionals. As more nephrology practices and units are participating in clinical trials, clinical research nursing is gaining interest as a career niche among nephrology nurses. This unique specialty requires that nephrology clinical nurse nurses (CRNs) reconcile the roles of nurse as caregiver and nurse as researcher, which may result in a role conflict. Nephrology nurses should be aware that they may experience this role conflict when transitioning from patient care to a position as a clinical research nurse. These nurses can rely on the American Nurses Association's Code of Ethics for Nurses and the Oncology Nursing Society's Oncology Clinical Trials Nurse Competencies to help reconcile the potential role conflict.

  9. Investigators' perspectives on translating human microbiome research into clinical practice.

    Science.gov (United States)

    Slashinski, M J; Whitney, S N; Achenbaum, L S; Keitel, W A; McCurdy, S A; McGuire, A L

    2013-01-01

    Human microbiome research has the potential to transform the practice of medicine, fundamentally shifting the ways in which we think not only about human health, illness and disease, but also about clinical practice and public health interventions. Drawing from a larger qualitative study on ethical, legal and social dimensions of human microbiome research, in this article, we document perspectives related to the translation of human microbiome research into clinical practice, focusing particularly on implications for health, illness and disease. We conducted 60 in-depth, semi-structured interviews (2009-2010) with 63 researchers and National Institutes of Health project leaders ('investigators') involved with human microbiome research. The interviews explored a range of ethical, legal and social implications of human microbiome research, including investigators' perspectives on potential strategies for translating findings to clinical practice. Using thematic content analysis, we identified and analyzed emergent themes and patterns. We identified 3 themes: (1) investigators' general perspectives on the clinical utility of human microbiome research, (2) investigators' perspectives on antibiotic use, overuse and misuse, and (3) investigators' perspectives concerning future challenges of translating data to clinical practice. The issues discussed by investigators concerning the clinical significance of human microbiome research, including embracing a new paradigm of health and disease, the importance of microbial communities, and clinical utility, will be of critical importance as this research moves forward. Copyright © 2013 S. Karger AG, Basel.

  10. Investigators’ Perspectives on Translating Human Microbiome Research into Clinical Practice

    Science.gov (United States)

    Slashinski, Melody J.; Whitney, Simon N.; Achenbaum, Laura S.; Keitel, Wendy A.; McCurdy, Sheryl A.; McGuire, Amy L.

    2013-01-01

    Background Human microbiome research has the potential to transform the practice of medicine, fundamentally shifting the ways in which we think not only about human health, illness, and disease, but also about clinical practice and public health interventions. Drawing from a larger qualitative study on ethical, legal, and social dimensions of human microbiome research, in this article we document perspectives related to the translation of human microbiome research into clinical practice, focusing particularly on implications for health, illness, and disease. Methods We conducted 60 in-depth, semi-structured interviews (2009–2010) with 63 researchers and National Institutes of Health project leaders (“investigators”) involved with human microbiome research. Interviews explored a range of ethical, legal, and social implications of human microbiome research, including investigators’ perspectives on potential strategies for translating findings to clinical practice. Using thematic content analysis, we identified and analyzed emergent themes and patterns. Results We identified three themes: (1) Investigators’ general perspectives on the clinical utility of human microbiome research, (2) Investigators’ perspectives on antibiotic use, overuse, and misuse, and (3) Investigators’ perspectives concerning future challenges of translating data to clinical practice. Conclusion The issues discussed by investigators concerning the clinical significance of human microbiome research, including embracing a new paradigm of health and disease, the importance of microbial communities, and clinical utility, will be of critical importance as this research moves forward. PMID:23615375

  11. Knowledge Creation in Clinical Product Development Management Research

    DEFF Research Database (Denmark)

    Karlsson, Christer; Sköld, Martin

    2012-01-01

    This paper explores the clinical approach to management research and positions it in relation to other similar approaches. It achieves this by pointing out the most important historical milestones in the development of such approaches. The literature on the approach is mapped, including...... of the approaches, the paper discusses the research issues to which clinical research is relevant and how the research framework should be designed, then practical issues relating to how to approach the study objects, the design of the research instruments, and the conducting of the field research. Finally......, it presents the method for analysing and drawing conclusions....

  12. [Computerized system validation of clinical researches].

    Science.gov (United States)

    Yan, Charles; Chen, Feng; Xia, Jia-lai; Zheng, Qing-shan; Liu, Daniel

    2015-11-01

    Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.

  13. Conflict of interest in clinical research

    Directory of Open Access Journals (Sweden)

    Ravindra B Ghooi

    2015-01-01

    Full Text Available Increased focus on ethical review of research demands a number of improvements in the existing system. Although these are being implemented, some factors that have received less attention in the past could be examined. One of these is conflict of interest. Such conflicts could exist for investigators, ethics committee (EC members, and even the regulators. Guidance for identification and management of conflicts has been issued by many countries and Indian rules also speak about these conflicts. Greater clarity would help investigators and ECs manage conflicts more effectively. It is admitted that conflicts cannot be done away with, but their timely identification, disclosure, and management can reduce their impact and bring more transparency and accountability to trials in this country.

  14. Data management by using R: big data clinical research series.

    Science.gov (United States)

    Zhang, Zhongheng

    2015-11-01

    Electronic medical record (EMR) system has been widely used in clinical practice. Instead of traditional record system by hand writing and recording, the EMR makes big data clinical research feasible. The most important feature of big data research is its real-world setting. Furthermore, big data research can provide all aspects of information related to healthcare. However, big data research requires some skills on data management, which however, is always lacking in the curriculum of medical education. This greatly hinders doctors from testing their clinical hypothesis by using EMR. To make ends meet, a series of articles introducing data management techniques are put forward to guide clinicians to big data clinical research. The present educational article firstly introduces some basic knowledge on R language, followed by some data management skills on creating new variables, recoding variables and renaming variables. These are very basic skills and may be used in every project of big data research.

  15. The Microcomputer in the Clinical Nursing Research Unit

    Science.gov (United States)

    Schwirian, Patricia M.; Byers, Sandra R.

    1982-01-01

    This paper discusses the microcomputer in clinical nursing research. There are six general areas in which computers have been useful to nurses: nursing notes and charting; patient care plans; automated monitoring of high-tech nursing units; HIS and MIS systems; personnel distribution systems; and education. Three alternative models for the conduct of clinical nursing research in a hospital are described. The first is a centralized model relying on the bureaucratic structure of the hospital. Second is a decentralized network of professional nurses and research support personnel woven together by a Clinical Nurse Researcher, and third is a dedicated clinical nursing research unit. Microcomputers have five characteristics which make them vital tools for nurse researchers: user-friendliness; environment friendliness; low cost; ease of interface with other information systems; and range and quality of software.

  16. [Organization of clinical research: in general and visceral surgery].

    Science.gov (United States)

    Schneider, M; Werner, J; Weitz, J; Büchler, M W

    2010-04-01

    The structural organization of research facilities within a surgical university center should aim at strengthening the department's research output and likewise provide opportunities for the scientific education of academic surgeons. We suggest a model in which several independent research groups within a surgical department engage in research projects covering various aspects of surgically relevant basic, translational or clinical research. In order to enhance the translational aspects of surgical research, a permanent link needs to be established between the department's scientific research projects and its chief interests in clinical patient care. Importantly, a focus needs to be placed on obtaining evidence-based data to judge the efficacy of novel diagnostic and treatment concepts. Integration of modern technologies from the fields of physics, computer science and molecular medicine into surgical research necessitates cooperation with external research facilities, which can be strengthened by coordinated support programs offered by research funding institutions.

  17. Effects of disclosing financial interests on attitudes toward clinical research.

    Science.gov (United States)

    Weinfurt, Kevin P; Hall, Mark A; Dinan, Michaela A; DePuy, Venita; Friedman, Joëlle Y; Allsbrook, Jennifer S; Sugarman, Jeremy

    2008-06-01

    The effects of disclosing financial interests to potential research participants are not well understood. To examine the effects of financial interest disclosures on potential research participants' attitudes toward clinical research. Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements. Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial. Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments. Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research.

  18. Integration of clinical research documentation in electronic health records.

    Science.gov (United States)

    Broach, Debra

    2015-04-01

    Clinical trials of investigational drugs and devices are often conducted within healthcare facilities concurrently with clinical care. With implementation of electronic health records, new communication methods are required to notify nonresearch clinicians of research participation. This article reviews clinical research source documentation, the electronic health record and the medical record, areas in which the research record and electronic health record overlap, and implications for the research nurse coordinator in documentation of the care of the patient/subject. Incorporation of clinical research documentation in the electronic health record will lead to a more complete patient/subject medical record in compliance with both research and medical records regulations. A literature search provided little information about the inclusion of clinical research documentation within the electronic health record. Although regulations and guidelines define both source documentation and the medical record, integration of research documentation in the electronic health record is not clearly defined. At minimum, the signed informed consent(s), investigational drug or device usage, and research team contact information should be documented within the electronic health record. Institutional policies should define a standardized process for this integration in the absence federal guidance. Nurses coordinating clinical trials are in an ideal position to define this integration.

  19. A survey of patients' attitudes to clinical research.

    LENUS (Irish Health Repository)

    Desmond, A

    2011-04-01

    Every year hundreds of patients voluntarily participate in clinical trials across Ireland. However, little research has been done as to how patients find the experience. This survey was conducted in an attempt to ascertain clinical trial participants\\' views on their experience of participating in a clinical trial and to see and how clinical trial participation can be improved. One hundred and sixty-six clinical trial participants who had recently completed a global phase IV cardiovascular endpoint clinical trial were sent a 3-page questionnaire. Ninety-one (91%) respondents found the experience of participating in a clinical trial a good one with 85 (84.16%) respondents saying they would recommend participating in a clinical trial to a friend or relative and eighty-five (87.63%) respondents feeling they received better healthcare because they had participated in a clinical trial.

  20. Discovering hidden viral piracy.

    Science.gov (United States)

    Kim, Eddo; Kliger, Yossef

    2005-12-01

    Viruses and developers of anti-inflammatory therapies share a common interest in proteins that manipulate the immune response. Large double-stranded DNA viruses acquire host proteins to evade host defense mechanisms. Hence, viral pirated proteins may have a therapeutic potential. Although dozens of viral piracy events have already been identified, we hypothesized that sequence divergence impedes the discovery of many others. We developed a method to assess the number of viral/human homologs and discovered that at least 917 highly diverged homologs are hidden in low-similarity alignment hits that are usually ignored. However, these low-similarity homologs are masked by many false alignment hits. We therefore applied a filtering method to increase the proportion of viral/human homologous proteins. The homologous proteins we found may facilitate functional annotation of viral and human proteins. Furthermore, some of these proteins play a key role in immune modulation and are therefore therapeutic protein candidates.

  1. Reflections on clinical research in sub-Saharan Africa.

    Science.gov (United States)

    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.

  2. A metadata schema for data objects in clinical research.

    Science.gov (United States)

    Canham, Steve; Ohmann, Christian

    2016-11-24

    A large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). To make the best use of such resources, we assert that it is also necessary for stakeholders to agree and deploy a simple, consistent metadata scheme. The relevant data objects and their likely storage are described, and the requirements for metadata to support data sharing in clinical research are identified. Issues concerning persistent identifiers, for both studies and data objects, are explored. A scheme is proposed that is based on the DataCite standard, with extensions to cover the needs of clinical researchers, specifically to provide (a) study identification data, including links to clinical trial registries; (b) data object characteristics and identifiers; and (c) data covering location, ownership and access to the data object. The components of the metadata scheme are described. The metadata schema is proposed as a natural extension of a widely agreed standard to fill a gap not tackled by other standards related to clinical research (e.g., Clinical Data Interchange Standards Consortium, Biomedical Research Integrated Domain Group). The proposal could be integrated with, but is not dependent on, other moves to better structure data in clinical research.

  3. Participation in HIV research: the importance of clinic contact factors.

    Science.gov (United States)

    Worthington, Catherine A; Gill, M John

    2008-08-01

    Recruiting minority populations living with HIV to many types of clinic-based HIV research is a concern. This study examined an expanded range of predictors of HIV research participation (clinic contact, clinical, and personal characteristics) to investigate observed ethnocultural differences in HIV research participation. Research participation was defined as participation in any of diagnostic, pathogenesis, drug trial or survey research. Logistic regression modeling was used to predict research participation of 657 eligible patients (93% of the patient population) who began care between January 1997 and the end of September 2003 at a regional outpatient HIV care program in Calgary, Canada. Approximately one third (32%) were non-white, including 18% Aboriginal, 9% black, 4% Asian, and 1% Hispanic individuals. Twenty-nine percent (187/657) of the patients participated in at least one study of any kind. Multivariate analysis indicated that the strongest predictors of any research participation (including diagnostic, pathogenesis, drug trial, or survey studies) are clinical (including nadir CD4 count [odds ratio {OR} = 0.132, p percentage of appointments kept [OR = 1.022, p service use shown by these groups that may influence research participation. To attract under researched populations, attention should shift from the "who" of research participation to the "how" of clinical interactions.

  4. 76 FR 79273 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-12-21

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... Committee Act) that the Panel for Eligibility of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board will meet on...

  5. 76 FR 1212 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-01-07

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... Committee Act) that the Panel for Eligibility of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board will meet on...

  6. [Application of Delphi method in traditional Chinese medicine clinical research].

    Science.gov (United States)

    Bi, Ying-fei; Mao, Jing-yuan

    2012-03-01

    In recent years, Delphi method has been widely applied in traditional Chinese medicine (TCM) clinical research. This article analyzed the present application situation of Delphi method in TCM clinical research, and discussed some problems presented in the choice of evaluation method, classification of observation indexes and selection of survey items. On the basis of present application of Delphi method, the author analyzed the method on questionnaire making, selection of experts, evaluation of observation indexes and selection of survey items. Furthermore, the author summarized the steps of application of Delphi method in TCM clinical research.

  7. Integrating Bioethics into Clinical and Translational Science Research: A Roadmap

    Science.gov (United States)

    Shapiro, Robyn S.; Layde, Peter M.

    2008-01-01

    Abstract Recent initiatives to improve human health emphasize the need to effectively and appropriately translate new knowledge gleaned from basic biomedical and behavioral research to clinical and community application. To maximize the beneficial impact of scientific advances in clinical practice and community health, and to guard against potential deleterious medical and societal consequences of such advances, incorporation of bioethics at each stage of clinical and translational science research is essential. At the earliest stage, bioethics input is critical to address issues such as whether to limit certain areas of scientific inquiry. Subsequently, bioethics input is important to assure not only that human subjects trials are conducted and reported responsibly, but also that results are incorporated into clinical and community practices in a way that promotes and protects bioethical principles. At the final stage of clinical and translational science research, bioethics helps to identify the need and approach for refining clinical practices when safety or other concerns arise. The framework we present depicts how bioethics interfaces with each stage of clinical and translational science research, and suggests an important research agenda for systematically and comprehensively assuring bioethics input into clinical and translational science initiatives. PMID:20443821

  8. Using Clinical Data, Hypothesis Generation Tools and PubMed Trends to Discover the Association between Diabetic Retinopathy and Antihypertensive Drugs

    Energy Technology Data Exchange (ETDEWEB)

    Senter, Katherine G [ORNL; Sukumar, Sreenivas R [ORNL; Patton, Robert M [ORNL; Chaum, Ed [University of Tennessee, Knoxville (UTK)

    2015-01-01

    Diabetic retinopathy (DR) is a leading cause of blindness and common complication of diabetes. Many diabetic patients take antihypertensive drugs to prevent cardiovascular problems, but these drugs may have unintended consequences on eyesight. Six common classes of antihypertensive drug are angiotensin converting enzyme (ACE) inhibitors, alpha blockers, angiotensin receptor blockers (ARBs), -blockers, calcium channel blockers, and diuretics. Analysis of medical history data might indicate which of these drugs provide safe blood pressure control, and a literature review is often used to guide such analyses. Beyond manual reading of relevant publications, we sought to identify quantitative trends in literature from the biomedical database PubMed to compare with quantitative trends in the clinical data. By recording and analyzing PubMed search results, we found wide variation in the prevalence of each antihypertensive drug in DR literature. Drug classes developed more recently such as ACE inhibitors and ARBs were most prevalent. We also identified instances of change-over-time in publication patterns. We then compared these literature trends to a dataset of 500 diabetic patients from the UT Hamilton Eye Institute. Data for each patient included class of antihypertensive drug, presence and severity of DR. Graphical comparison revealed that older drug classes such as diuretics, calcium channel blockers, and -blockers were much more prevalent in the clinical data than in the DR and antihypertensive literature. Finally, quantitative analysis of the dataset revealed that patients taking -blockers were statistically more likely to have DR than patients taking other medications, controlling for presence of hypertension and year of diabetes onset. This finding was concerning given the prevalence of -blockers in the clinical data. We determined that clinical use of -blockers should be minimized in diabetic patients to prevent retinal damage.

  9. Clinical Research Informatics for Big Data and Precision Medicine.

    Science.gov (United States)

    Weng, C; Kahn, M G

    2016-11-10

    To reflect on the notable events and significant developments in Clinical Research Informatics (CRI) in the year of 2015 and discuss near-term trends impacting CRI. We selected key publications that highlight not only important recent advances in CRI but also notable events likely to have significant impact on CRI activities over the next few years or longer, and consulted the discussions in relevant scientific communities and an online living textbook for modern clinical trials. We also related the new concepts with old problems to improve the continuity of CRI research. The highlights in CRI in 2015 include the growing adoption of electronic health records (EHR), the rapid development of regional, national, and global clinical data research networks for using EHR data to integrate scalable clinical research with clinical care and generate robust medical evidence. Data quality, integration, and fusion, data access by researchers, study transparency, results reproducibility, and infrastructure sustainability are persistent challenges. The advances in Big Data Analytics and Internet technologies together with the engagement of citizens in sciences are shaping the global clinical research enterprise, which is getting more open and increasingly stakeholder-centered, where stakeholders include patients, clinicians, researchers, and sponsors.

  10. Clinical Research Informatics and Electronic Health Record Data

    Science.gov (United States)

    Horvath, M. M.; Rusincovitch, S. A.

    2014-01-01

    Summary Objectives The goal of this survey is to discuss the impact of the growing availability of electronic health record (EHR) data on the evolving field of Clinical Research Informatics (CRI), which is the union of biomedical research and informatics. Results Major challenges for the use of EHR-derived data for research include the lack of standard methods for ensuring that data quality, completeness, and provenance are sufficient to assess the appropriateness of its use for research. Areas that need continued emphasis include methods for integrating data from heterogeneous sources, guidelines (including explicit phenotype definitions) for using these data in both pragmatic clinical trials and observational investigations, strong data governance to better understand and control quality of enterprise data, and promotion of national standards for representing and using clinical data. Conclusions The use of EHR data has become a priority in CRI. Awareness of underlying clinical data collection processes will be essential in order to leverage these data for clinical research and patient care, and will require multi-disciplinary teams representing clinical research, informatics, and healthcare operations. Considerations for the use of EHR data provide a starting point for practical applications and a CRI research agenda, which will be facilitated by CRI’s key role in the infrastructure of a learning healthcare system. PMID:25123746

  11. Cyclotrons for clinical and biomedical research with PET

    International Nuclear Information System (INIS)

    Wolf, A.P.

    1987-01-01

    The purpose of this commentary is to present some background material on cyclotrons and other particle accelerators particularly with a view toward the considerations behind acquiring and installing such a machine for purely clinical and/or biomedical research use

  12. A proposed clinical research support career pathway for noninvestigators.

    Science.gov (United States)

    Smith, Sheree; Gullick, Janice; Ballard, Jacqueline; Perry, Lin

    2018-03-08

    To discuss the international experience of clinical research support for noninvestigator roles and to propose a new pathway for Australia, to promote a sustainable research support workforce capable of delivering high-quality clinical research. Noninvestigator research support roles are currently characterized by an ad hoc approach to training, with limited role delineation and perceived professional isolation with implications for study completion rates and participant safety. A focused approach to developing and implementing research support pathways has improved patient recruitment, study completion, job satisfaction, and research governance. The Queensland and New South Wales state-based Nurses' Awards, the Australian Qualifications Framework, and a University Professional (Research) Staff Award. Research nurses in the clinical environment improve study coordination, adherence to study protocol, patient safety, and clinical care. A career pathway that guides education and outlines position descriptions and skill sets would enhance development of the research support workforce. This pathway could contribute to changing the patient outcomes through coordination and study completion of high-quality research. A wide consultative approach is required to determine a cost-effective and feasible approach to implementation and evaluation of the proposed pathway. © 2018 John Wiley & Sons Australia, Ltd.

  13. Discovering genes underlying QTL

    Energy Technology Data Exchange (ETDEWEB)

    Vanavichit, Apichart [Kasetsart University, Kamphaengsaen, Nakorn Pathom (Thailand)

    2002-02-01

    A map-based approach has allowed scientists to discover few genes at a time. In addition, the reproductive barrier between cultivated rice and wild relatives has prevented us from utilizing the germ plasm by a map-based approach. Most genetic traits important to agriculture or human diseases are manifested as observable, quantitative phenotypes called Quantitative Trait Loci (QTL). In many instances, the complexity of the phenotype/genotype interaction and the general lack of clearly identifiable gene products render the direct molecular cloning approach ineffective, thus additional strategies like genome mapping are required to identify the QTL in question. Genome mapping requires no prior knowledge of the gene function, but utilizes statistical methods to identify the most likely gene location. To completely characterize genes of interest, the initially mapped region of a gene location will have to be narrowed down to a size that is suitable for cloning and sequencing. Strategies for gene identification within the critical region have to be applied after the sequencing of a potentially large clone or set of clones that contains this gene(s). Tremendous success of positional cloning has been shown for cloning many genes responsible for human diseases, including cystic fibrosis and muscular dystrophy as well as plant disease resistance genes. Genome and QTL mapping, positional cloning: the pre-genomics era, comparative approaches to gene identification, and positional cloning: the genomics era are discussed in the report. (M. Suetake)

  14. Discovering genes underlying QTL

    International Nuclear Information System (INIS)

    Vanavichit, Apichart

    2002-01-01

    A map-based approach has allowed scientists to discover few genes at a time. In addition, the reproductive barrier between cultivated rice and wild relatives has prevented us from utilizing the germ plasm by a map-based approach. Most genetic traits important to agriculture or human diseases are manifested as observable, quantitative phenotypes called Quantitative Trait Loci (QTL). In many instances, the complexity of the phenotype/genotype interaction and the general lack of clearly identifiable gene products render the direct molecular cloning approach ineffective, thus additional strategies like genome mapping are required to identify the QTL in question. Genome mapping requires no prior knowledge of the gene function, but utilizes statistical methods to identify the most likely gene location. To completely characterize genes of interest, the initially mapped region of a gene location will have to be narrowed down to a size that is suitable for cloning and sequencing. Strategies for gene identification within the critical region have to be applied after the sequencing of a potentially large clone or set of clones that contains this gene(s). Tremendous success of positional cloning has been shown for cloning many genes responsible for human diseases, including cystic fibrosis and muscular dystrophy as well as plant disease resistance genes. Genome and QTL mapping, positional cloning: the pre-genomics era, comparative approaches to gene identification, and positional cloning: the genomics era are discussed in the report. (M. Suetake)

  15. Bridging the gap between outputs of clinical research and utilisation ...

    African Journals Online (AJOL)

    Worldwide clinical research efforts do not necessarily translate to improved outcomes in clinical practice. However, with the rising challenge facing clinicians in the midst of an environment of increasing health care choices, rising expectations and limited resources, the awareness of this lag is rising globally and health ...

  16. Sex differences in health research and clinical guideline development

    NARCIS (Netherlands)

    Keuken, D.G.

    2008-01-01

    In current medical practice, research based evidence is an important foundation for clinical decision making. Clinical practice guidelines are a major instrument for keeping physicians up-to-date about this evidence. In order to provide optimal care to both men and women, it is important that sex

  17. The clinical research office of the endourological society audit committee

    NARCIS (Netherlands)

    Preminger, Glenn M.; Alken, Peter; Habuchi, Tomonori; Wijkstra, Hessel; Skolarikos, Andreas; Yin, Chan-Jun

    2011-01-01

    The Clinical Research Office of the Endourological Society (CROES) conducts large-scale, international, multicenter clinical trials in the field of endourology. One of the major challenges that these trials pose is to ensure that data collected remotely and online within a very short time frame are

  18. Clinical code set engineering for reusing EHR data for research: A review.

    Science.gov (United States)

    Williams, Richard; Kontopantelis, Evangelos; Buchan, Iain; Peek, Niels

    2017-06-01

    The construction of reliable, reusable clinical code sets is essential when re-using Electronic Health Record (EHR) data for research. Yet code set definitions are rarely transparent and their sharing is almost non-existent. There is a lack of methodological standards for the management (construction, sharing, revision and reuse) of clinical code sets which needs to be addressed to ensure the reliability and credibility of studies which use code sets. To review methodological literature on the management of sets of clinical codes used in research on clinical databases and to provide a list of best practice recommendations for future studies and software tools. We performed an exhaustive search for methodological papers about clinical code set engineering for re-using EHR data in research. This was supplemented with papers identified by snowball sampling. In addition, a list of e-phenotyping systems was constructed by merging references from several systematic reviews on this topic, and the processes adopted by those systems for code set management was reviewed. Thirty methodological papers were reviewed. Common approaches included: creating an initial list of synonyms for the condition of interest (n=20); making use of the hierarchical nature of coding terminologies during searching (n=23); reviewing sets with clinician input (n=20); and reusing and updating an existing code set (n=20). Several open source software tools (n=3) were discovered. There is a need for software tools that enable users to easily and quickly create, revise, extend, review and share code sets and we provide a list of recommendations for their design and implementation. Research re-using EHR data could be improved through the further development, more widespread use and routine reporting of the methods by which clinical codes were selected. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  19. Implementing Clinical Research Using Factorial Designs: A Primer.

    Science.gov (United States)

    Baker, Timothy B; Smith, Stevens S; Bolt, Daniel M; Loh, Wei-Yin; Mermelstein, Robin; Fiore, Michael C; Piper, Megan E; Collins, Linda M

    2017-07-01

    Factorial experiments have rarely been used in the development or evaluation of clinical interventions. However, factorial designs offer advantages over randomized controlled trial designs, the latter being much more frequently used in such research. Factorial designs are highly efficient (permitting evaluation of multiple intervention components with good statistical power) and present the opportunity to detect interactions amongst intervention components. Such advantages have led methodologists to advocate for the greater use of factorial designs in research on clinical interventions (Collins, Dziak, & Li, 2009). However, researchers considering the use of such designs in clinical research face a series of choices that have consequential implications for the interpretability and value of the experimental results. These choices include: whether to use a factorial design, selection of the number and type of factors to include, how to address the compatibility of the different factors included, whether and how to avoid confounds between the type and number of interventions a participant receives, and how to interpret interactions. The use of factorial designs in clinical intervention research poses choices that differ from those typically considered in randomized clinical trial designs. However, the great information yield of the former encourages clinical researchers' increased and careful execution of such designs. Copyright © 2017. Published by Elsevier Ltd.

  20. Site Characteristics Influencing the Translation of Clinical Research Into Clinical Practice

    DEFF Research Database (Denmark)

    Smed, Marie; Getz, Kenneth A.

    2014-01-01

    Investigative sites participating in clinical trials play an instrumental role in aiding market adoption. Site experiences in clinical research help physician investigators and research professionals gain familiarity with and exposure to investigational treatments. This knowledge may be passed...... on to sponsor companies and may ultimately assist in positioning new products and driving commercialization success. This study evaluates site characteristics that influence the acquisition and sharing of knowledge gained through clinical trial experience. The impact of 2 central site characteristics...

  1. Clinical diabetes research using data mining: a Canadian perspective.

    Science.gov (United States)

    Shah, Baiju R; Lipscombe, Lorraine L

    2015-06-01

    With the advent of the digitization of large amounts of information and the computer power capable of analyzing this volume of information, data mining is increasingly being applied to medical research. Datasets created for administration of the healthcare system provide a wealth of information from different healthcare sectors, and Canadian provinces' single-payer universal healthcare systems mean that data are more comprehensive and complete in this country than in many other jurisdictions. The increasing ability to also link clinical information, such as electronic medical records, laboratory test results and disease registries, has broadened the types of data available for analysis. Data-mining methods have been used in many different areas of diabetes clinical research, including classic epidemiology, effectiveness research, population health and health services research. Although methodologic challenges and privacy concerns remain important barriers to using these techniques, data mining remains a powerful tool for clinical research. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

  2. Influences upon pediatricians’ willingness to refer patients to clinical research

    Directory of Open Access Journals (Sweden)

    Jeanne Dalen

    2010-03-01

    Full Text Available Jeanne Dalen1, Robert D Annett2, Janet L Brody1, Mandy L Perryman31Center for Family and Adolescent Research, Oregon Research Institute, Portland, OR, USA; 2University of New Mexico Health Sciences Center, Albuquerque, NM, USA; 3School of Education and Human Development, Lynchburg College, Lynchburg, UA, USAPurpose: The purpose of this brief report is to determine factors that influence the willingness of pediatricians to refer their patients to clinical research and to explore the relationship between pediatrician characteristics and self-reported number of patients referred to clinical research.Method: Forty-three pediatricians from an academic pediatrics department of a university children’s hospital in Albuquerque, New Mexico rated how influential 10 reasons would be in their decision to refer a patient to pediatric clinical research.Results: Differences among the influences for pediatrician referral to research were observed. The most influential consideration for referral was the scientific merit of the study, followed by patient benefit. Contextual factors and physician compensation were identified as the least important reasons pediatricians refer patients to research. Analyses also revealed significant relationships between referrals made and percentage of time spent in research activities.Conclusions: Pediatricians may be more likely to refer their patients to clinical research studies when they believe the purpose of the study is meaningful to patients as well as to future patient populations. In addition, characteristics of the individual pediatricians may play an important role in actual referral behavior.Keywords: recruitment, clinical research, adolescent research, pediatrician attitudes

  3. Effects of Disclosing Financial Interests on Attitudes Toward Clinical Research

    Science.gov (United States)

    Hall, Mark A.; Dinan, Michaela A.; DePuy, Venita; Friedman, Joëlle Y.; Allsbrook, Jennifer S.; Sugarman, Jeremy

    2008-01-01

    Background The effects of disclosing financial interests to potential research participants are not well understood. Objective To examine the effects of financial interest disclosures on potential research participants’ attitudes toward clinical research. Design and Participants Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements. Measurements Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial. Results Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments. Conclusions Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research. Electronic supplementary material The online version of this article (doi:10.1007/s11606-008-0590-4) contains supplementary material, which is available to authorized users. PMID:18386101

  4. US-LA CRN Clinical Cancer Research in Latin America

    Science.gov (United States)

    The United States – Latin America Cancer Research Network (US-LA CRN) convened its Annual Meeting, in coordination with the Ministry of Health of Chile to discuss the Network’s first multilateral clinical research study: Molecular Profiling of Breast Cancer (MPBC).

  5. Clinical Research Environment in India: Challenges and Proposed Solutions.

    Science.gov (United States)

    Burt, Tal; Sharma, Pooja; Dhillon, Savita; Manchanda, Mukul; Mittal, Sanjay; Trehan, Naresh

    2014-11-01

    India has compelling need and keen aspirations for indigenous clinical research. Notwithstanding this need and previously reported growth the expected expansion of Indian clinical research has not materialized. We reviewed the scientific literature, lay press reports, and ClinicalTrials.gov data for information and commentary on projections, progress, and impediments associated with clinical trials in India. We also propose targeted solutions to identified challenges. The Indian clinical trial sector grew by (+) 20.3% CAGR (compound annual growth rate) between 2005 and 2010 and contracted by (-) 14.6% CAGR between 2010 and 2013. Phase-1 trials grew by (+) 43.5% CAGR from 2005-2013, phase-2 trials grew by (+) 19.8% CAGR from 2005-2009 and contracted by (-) 12.6% CAGR from 2009-2013, and phase-3 trials grew by (+) 13.0% CAGR from 2005-2010 and contracted by (-) 28.8% CAGR from 2010-2013. This was associated with a slowing of the regulatory approval process, increased media coverage and activist engagement, and accelerated development of regulatory guidelines and recuperative initiatives. We propose the following as potential targets for restorative interventions: Regulatory overhaul (leadership and enforcement of regulations, resolution of ambiguity in regulations, staffing, training, guidelines, and ethical principles [e.g., compensation]).Education and training of research professionals, clinicians, and regulators.Public awareness and empowerment. After a peak in 2009-2010, the clinical research sector in India appears to be experiencing a contraction. There are indications of challenges in regulatory enforcement of guidelines; training of clinical research professionals; and awareness, participation, partnership, and the general image amongst the non-professional media and public. Preventative and corrective principles and interventions are outlined with the goal of realizing the clinical research potential in India.

  6. Physician participation in clinical research and trials: issues and approaches

    Directory of Open Access Journals (Sweden)

    Sami F Shaban

    2011-03-01

    Full Text Available Sayeeda Rahman1, Md Anwarul Azim Majumder1, Sami F Shaban2, Nuzhat Rahman3, Moslehuddin Ahmed4, Khalid Bin Abdulrahman5, Urban JA D’Souza61Department of Clinical Sciences, School of Life Sciences, University of Bradford, West Yorkshire, Bradford, UK; 2Department of Medical Education, Faculty of Medicine and Health Sciences, UAE University, Al-Ain, United Arab Emirates; 3Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA; 4Department of Community Medicine, Uttara Adhunik Medical College, Dhaka, Bangladesh; 5Department of Family Medicine and Medical Education, College of Medicine, Al-Imam University, Riyadh, Saudi Arabia; 6Department of Post Graduate Studies, School of Medicine, University Malaysia Sabah, Kota Kinabalu, Sabah, MalaysiaAbstract: The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system- or organization-related as well as research- and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and

  7. Clinical research ethics in Irish healthcare: diversity, dynamism and medicalization.

    LENUS (Irish Health Repository)

    Condell, Sarah L

    2012-11-01

    Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as an early \\'rite of passage\\' in the category of \\'labouring the doctorate\\'. This article penetrates the complexities in Irish clinical research ethics by describing the practices these nurse and midwife researchers encountered and the experiences they had. The key issue of representation that occurred in the context of \\'medicalized\\' research ethics is further explored including its meaning for nursing or midwifery research.

  8. Qualitative Research in Palliative Care: Applications to Clinical Trials Work.

    Science.gov (United States)

    Lim, Christopher T; Tadmor, Avia; Fujisawa, Daisuke; MacDonald, James J; Gallagher, Emily R; Eusebio, Justin; Jackson, Vicki A; Temel, Jennifer S; Greer, Joseph A; Hagan, Teresa; Park, Elyse R

    2017-08-01

    While vast opportunities for using qualitative methods exist within palliative care research, few studies provide practical advice for researchers and clinicians as a roadmap to identify and utilize such opportunities. To provide palliative care clinicians and researchers descriptions of qualitative methodology applied to innovative research questions relative to palliative care research and define basic concepts in qualitative research. Body: We describe three qualitative projects as exemplars to describe major concepts in qualitative analysis of early palliative care: (1) a descriptive analysis of clinician documentation in the electronic health record, (2) a thematic content analysis of palliative care clinician focus groups, and (3) a framework analysis of audio-recorded encounters between patients and clinicians as part of a clinical trial. This study provides a foundation for undertaking qualitative research within palliative care and serves as a framework for use by other palliative care researchers interested in qualitative methodologies.

  9. Exploring the value of qualitative research films in clinical education.

    Science.gov (United States)

    Toye, Fran; Jenkins, Sue; Seers, Kate; Barker, Karen

    2015-11-27

    Many healthcare professionals use both quantitative and qualitative research to inform their practice. The usual way to access research findings is through peer-reviewed publications. This study aimed to understand the impact on healthcare professionals of watching and discussing a short research based film. The film, 'Struggling to be me' portrays findings from a qualitative synthesis exploring people's experiences of chronic pain, and was delivered as part of an inter-professional postgraduate e-learning module. The innovation of our study is to be the first to explore the impact of qualitative research portrayed through the medium of film in clinical education. All nineteen healthcare professionals enrolled on the course in December 2013 took part in on-line interviews or focus groups. We recorded and transcribed the interviews verbatim and used the methods of Grounded Theory to analyse the interview transcripts. Watching and discussing the film became a stimulus for learning : (a) A glimpse beneath the surface explored a pro-active way of seeing the person behind the pain (b) Pitfalls of the Medical Model recognised the challenge, for both patient and clinician, of 'sitting with' rather than 'fixing' an ill person; (c) Feeling bombarded by despair acknowledged the intense emotions that the clinicians brings to the clinical encounter; (d) Reconstructing the clinical encounter as a shared journey reconstructed the time-constrained clinical encounter as a single step on a shared journey towards healing, rather than fixing. Films portraying qualitative research findings can stimulate a pro-active and dialectic form of knowing. Research-based qualitative films can make qualitative findings accessible and can be a useful resource in clinical training. Our research presents, for the first time, specific learning themes for clinical education.

  10. Clinical nursing and midwifery research: grey literature in African countries.

    Science.gov (United States)

    Sun, C; Dohrn, J; Omoni, G; Malata, A; Klopper, H; Larson, E

    2016-03-01

    This study reviewed grey literature to assess clinical nursing and midwifery research conducted in southern and eastern African countries over the past decade. The shortage of published nursing research from African countries severely limits the ability of practicing nurses and midwives to base clinical decisions on solid evidence. However, little is known regarding unpublished or unindexed clinical research ('grey literature'), a potentially rich source of information. Identifying these sources may reveal resources to assist nurses in providing evidence-based care. This scoping review of grey literature on clinical nursing and midwifery research in southern and eastern African countries helped to identify gaps in research and assess whether these gaps differ from published research. Systematic searches of grey literature were performed. Research was included if it was conducted by nurses in 1 of 25 southern or eastern African countries, between 2004 and 2014 and included patient outcomes. Data were extracted on location, institution, research topic, institutional connections and author information. Chi-square tests were performed to compare differences between indexed and non-indexed literature. We found 262 studies by 287 authors from 17 southern and eastern African countries covering 13 topics. Although all topics were also found in indexed literature and there were statistically significant differences between the number of times, fewer topics were covered in grey literature vs. indexed. Patient satisfaction and experience and traditional health practices were more likely to be published, whereas chronic disease, assault and paediatric-related research were less often published. Generally, there is a paucity of clinical nursing research in this region. This could reflect the shortage of nurses prepared to conduct research in this region. Nurses may find additional resources for evidence in the grey literature. A complete understanding of the state of nursing

  11. Characteristics desired in clinical data warehouse for biomedical research.

    Science.gov (United States)

    Shin, Soo-Yong; Kim, Woo Sung; Lee, Jae-Ho

    2014-04-01

    Due to the unique characteristics of clinical data, clinical data warehouses (CDWs) have not been successful so far. Specifically, the use of CDWs for biomedical research has been relatively unsuccessful thus far. The characteristics necessary for the successful implementation and operation of a CDW for biomedical research have not clearly defined yet. THREE EXAMPLES OF CDWS WERE REVIEWED: a multipurpose CDW in a hospital, a CDW for independent multi-institutional research, and a CDW for research use in an institution. After reviewing the three CDW examples, we propose some key characteristics needed in a CDW for biomedical research. A CDW for research should include an honest broker system and an Institutional Review Board approval interface to comply with governmental regulations. It should also include a simple query interface, an anonymized data review tool, and a data extraction tool. Also, it should be a biomedical research platform for data repository use as well as data analysis. The proposed characteristics desired in a CDW may have limited transfer value to organizations in other countries. However, these analysis results are still valid in Korea, and we have developed clinical research data warehouse based on these desiderata.

  12. The Ethics of Clinical Trials Research in Severe Mood Disorders.

    Science.gov (United States)

    Nugent, Allison C; Miller, Franklin G; Henter, Ioline D; Zarate, Carlos A

    2017-07-01

    Mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD), are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including patients' motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  13. The PRIME curriculum. Clinical research training during residency.

    Science.gov (United States)

    Kohlwes, R J; Shunk, R L; Avins, A; Garber, J; Bent, S; Shlipak, M G

    2006-05-01

    The Primary Medical Education (PRIME) program is an outpatient-based, internal medicine residency track nested within the University of California, San Francisco (UCSF) categorical medicine program. Primary Medical Education is based at the San Francisco Veteran's Affairs Medical Center (VAMC), 1 of 3 teaching hospitals at UCSF. The program accepts 8 UCSF medicine residents annually, who differentiate into PRIME after internship. In 2000, we implemented a novel research methods curriculum with the dual purposes of teaching basic epidemiology skills and providing mentored opportunities for clinical research projects during residency. Single academic internal medicine program. The PRIME curriculum utilizes didactic lecture, frequent journal clubs, work-in-progress sessions, and active mentoring to enable residents to "try out" a clinical research project during residency. Among 32 residents in 4 years, 22 residents have produced 20 papers in peer-reviewed journals, 1 paper under review, and 2 book chapters. Their clinical evaluations are equivalent to other UCSF medicine residents. While learning skills in evidence-based medicine, residents can conduct high-quality research. Utilizing a collaboration of General Internal Medicine researchers and educators, our curriculum affords residents the opportunity to "try-out" clinical research as a potential future career choice.

  14. More ethical and more efficient clinical research: multiplex trial design.

    Science.gov (United States)

    Keus, Frederik; van der Horst, Iwan C C; Nijsten, Maarten W

    2014-08-14

    Today's clinical research faces challenges such as a lack of clinical equipoise between treatment arms, reluctance in randomizing for multiple treatments simultaneously, inability to address interactions and increasingly restricted resources. Furthermore, many trials are biased by extensive exclusion criteria, relatively small sample size and less appropriate outcome measures. We propose a 'Multiplex' trial design that preserves clinical equipoise with a continuous and factorial trial design that will also result in more efficient use of resources. This multiplex design accommodates subtrials with appropriate choice of treatment arms within each subtrial. Clinical equipoise should increase consent rates while the factorial design is the best way to identify interactions. The multiplex design may evolve naturally from today's research limitations and challenges, while principal objections seem absent. However this new design poses important infrastructural, organisational and psychological challenges that need in depth consideration.

  15. Major clinical research advances in gynecologic cancer in 2014

    OpenAIRE

    Suh, Dong Hoon; Lee, Kyung-Hun; Kim, Kidong; Kang, Sokbom; Kim, Jae-Weon

    2015-01-01

    In 2014, 9 topics were selected as major advances in clinical research for gynecologic oncology: 2 each in cervical and corpus cancer, 4 in ovarian cancer, and 1 in breast cancer. For cervical cancer, several therapeutic agents showed viable antitumor clinical response in recurrent and metastatic disease: bevacizumab, cediranib, and immunotherapies including human papillomavirus (HPV)-tumor infiltrating lymphocytes and Z-100. The HPV test received FDA approval as the primary screening tool of...

  16. Major clinical research advances in gynecologic cancer in 2013

    OpenAIRE

    Suh, Dong Hoon; Kim, Jae-Weon; Kang, Sokbom; Kim, Hak Jae; Lee, Kyung-Hun

    2014-01-01

    In 2013, 10 topics were selected for major clinical research advances in gynecologic oncology; these included three topics regarding cervical cancer, three regarding ovarian cancer, two regarding endometrial cancer, and one each regarding breast cancer and radiation oncology. For cervical cancer, bevacizumab was first demonstrated to exhibit outstanding clinical efficacy in a recurrent, metastatic setting. Regarding cervical cancer screening, visual inspections with acetic acid in low-resourc...

  17. Radioactive isotopes in clinical medicine and research. Abstracts

    International Nuclear Information System (INIS)

    2005-01-01

    The contribution displays 44 abstracts and 35 posters from the 27th International Symposium on ''radioactive isotopes in clinical medicine and research'', organized by the Austrian society of nuclear medicine and the department of nuclear medicine and the center for biomedical engineering and physics of the Vienna medical university. The abstracts are sorted according to lecture headers: radiopharmaceutical sciences, endocrinology, clinical PET, neurology, oncology, physics and instrumentation, cardiology, inflammation, therapy and varia. (uke)

  18. Artificial Sight Basic Research, Biomedical Engineering, and Clinical Advances

    CERN Document Server

    Humayun, Mark S; Chader, Gerald; Greenbaum, Elias

    2008-01-01

    Artificial sight is a frontier area of modern ophthalmology combining the multidisciplinary skills of surgical ophthalmology, biomedical engineering, biological physics, and psychophysical testing. Many scientific, engineering, and surgical challenges must be surmounted before widespread practical applications can be realized. The goal of Artificial Sight is to summarize the state-of-the-art research in this exciting area, and to describe some of the current approaches and initiatives that may help patients in a clinical setting. The Editors are active researchers in the fields of artificial sight, biomedical engineering and biological physics. They have received numerous professional awards and recognition for their work. The artificial sight team at the Doheny Eye Institute, led by Dr. Mark Humayun, is a world leader in this area of biomedical engineering and clinical research. Key Features Introduces and assesses the state of the art for a broad audience of biomedical engineers, biophysicists, and clinical...

  19. Toward an Ontology-Based Framework for Clinical Research Databases

    Science.gov (United States)

    Kong, Y. Megan; Dahlke, Carl; Xiang, Qun; Qian, Yu; Karp, David; Scheuermann, Richard H.

    2010-01-01

    Clinical research includes a wide range of study designs from focused observational studies to complex interventional studies with multiple study arms, treatment and assessment events, and specimen procurement procedures. Participant characteristics from case report forms need to be integrated with molecular characteristics from mechanistic experiments on procured specimens. In order to capture and manage this diverse array of data, we have developed the Ontology-Based eXtensible conceptual model (OBX) to serve as a framework for clinical research data in the Immunology Database and Analysis Portal (ImmPort). By designing OBX around the logical structure of the Basic Formal Ontology (BFO) and the Ontology for Biomedical Investigations (OBI), we have found that a relatively simple conceptual model can represent the relatively complex domain of clinical research. In addition, the common framework provided by BFO makes it straightforward to develop data dictionaries based on reference and application ontologies from the OBO Foundry. PMID:20460173

  20. [Research development and thinking of clinical study of Polygonum multiflorum].

    Science.gov (United States)

    Wu, Cheng-Sheng; Sun, Rong

    2017-01-01

    In order to offer the accordance and research ideas for further research of effect, indication and ensure the safety and effectiveness of clinical medication, the current states of clinical application and adverse reaction of Polygonum multiflorum were summarized. The related literatures in recent years were collated, analyzed and summed up. P. multiflorum is widely used and has variety of adverse reactions. At present, it's used to treat hyperlipidemia, white hair, hair loss, hypertension, vitiligo, etc. Adverse reactions are liver damage, allergic reactions, mental symptoms, chronic enteritis, etc. The effect, indication and adverse reaction research of P. multiflorum is still insufficient, further study should be based on clinical practice, in the aspects of the authenticity of the drug, the disease syndrome, the phase of adverse reactions, individual heterogeneity and compatibility. Copyright© by the Chinese Pharmaceutical Association.

  1. Basic and clinical research advances in ischemic stroke

    Directory of Open Access Journals (Sweden)

    Yuan-yuan MA

    2018-01-01

    Full Text Available Stroke is the most common cerebrovascular disease worldwide, which seriously affects life quality of survivals and results in huge economic burden of families and society. In terms of clinical treatment for ischemic stroke, apart from thrombolytic therapy with recombinant tissue-type plasminogen activator (rt-PA, the occurrence and successful application of endovascular thrombectomy in patients of ischemic stroke is a major breakthrough. Meanwhile, many novel clinical drugs for ischemic stroke therapy have entered into clinical trials. Most of basic and clinical researches have showed promising results in ischemic stroke therapy. This review mainly summarizes the progress of research during the period of Twelfth Five-Year Plan for National Economic and Social Development on treatment of ischemic stroke, including omics technologies, gene therapy, microRNA (miRNA interference and stem cell therapy. Stem cell therapy has shown great potential since many clinical trials have been completed or are ongoing. The development and mutual transformation of basic and clinical research will provide valuable and comprehensive information for the precise treatment of ischemic stroke.

  2. Platelet Immunology in China: Research and Clinical Applications.

    Science.gov (United States)

    Wu, Guoguang; Zhou, Yan; Li, Lilan; Zhong, Zhoulin; Li, Hengchong; Li, Haiyan; Yu, Mei; Shen, Weidong; Ni, Heyu

    2017-04-01

    Immunization against human platelet alloantigens (HPAs) is associated with a number of clinical complications. The detection and identification of clinically relevant platelet antibodies are important for the diagnosis and management of patients affected with immune-mediated thrombocytopenias. Human platelet alloantigen frequencies and the characteristics of antiplatelet antibodies vary widely between ethnic groups. Since 2008, the importance of platelet immunology in the field of transfusion medicine has gained greater recognition by clinical laboratories in China. Laboratories in China have established and improved methods for platelet antibody detection and HPA genotyping techniques, which are used for the diagnosis of alloimmune platelet disorders in clinic and research environments. Research has revealed the frequencies of HPA alleles in different Chinese ethnic groups and compared the differences in HPA gene frequencies between the Chinese Han and other ethnic groups of the world. Production of anti-CD36 isoantibodies is an important risk factor for immune-mediated thrombocytopenia in the Chinese population. Advances in research and clinical application of platelet immunology have significantly improved the clinical diagnosis, treatment including transfusion support, and prevention of alloimmune platelet disorders in the Chinese population. Copyright © 2017. Published by Elsevier Inc.

  3. India's growing clinical research sector: opportunity for global companies.

    Science.gov (United States)

    Varawalla, Nermeen

    2007-06-01

    Backed by a compelling foundation of essential requirements necessary for effective clinical trial conduct, and aided by initiatives that address concerns of data quality, regulatory timelines and IP protection, the clinical development sector in India has experienced annual revenue growth rates of 25% in the past two to three years, and is poised to participate substantially in global drug development. As both clinical trial sponsors and CROs increase their research capabilities in India, the clinical development sector is facing challenges with staff resourcing and facilities. Existing initiatives in the clinical sector must continue, and further investment must be made by stakeholders to overcome the current limitations in sector growth. Furthermore, global organizations seeking to derive long-term sustainable revenue growth and competitive advantage in the global marketplace from their business units in India must establish an appropriate organizational culture and an effective intra-organizational and industry interface for their operations.

  4. Semantic processing of EHR data for clinical research.

    Science.gov (United States)

    Sun, Hong; Depraetere, Kristof; De Roo, Jos; Mels, Giovanni; De Vloed, Boris; Twagirumukiza, Marc; Colaert, Dirk

    2015-12-01

    There is a growing need to semantically process and integrate clinical data from different sources for clinical research. This paper presents an approach to integrate EHRs from heterogeneous resources and generate integrated data in different data formats or semantics to support various clinical research applications. The proposed approach builds semantic data virtualization layers on top of data sources, which generate data in the requested semantics or formats on demand. This approach avoids upfront dumping to and synchronizing of the data with various representations. Data from different EHR systems are first mapped to RDF data with source semantics, and then converted to representations with harmonized domain semantics where domain ontologies and terminologies are used to improve reusability. It is also possible to further convert data to application semantics and store the converted results in clinical research databases, e.g. i2b2, OMOP, to support different clinical research settings. Semantic conversions between different representations are explicitly expressed using N3 rules and executed by an N3 Reasoner (EYE), which can also generate proofs of the conversion processes. The solution presented in this paper has been applied to real-world applications that process large scale EHR data. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Closing the Gap between Research Evidence and Clinical Practice: Jordanian Nurses' Perceived Barriers to Research Utilisation

    Science.gov (United States)

    Al Khalaileh, Murad; Al Qadire, Mohammad; Musa, Ahmad S.; Al-Khawaldeh, Omar A.; Al Qudah, Hani; Alhabahbeh, Atalla

    2016-01-01

    Background: The nursing profession is a combination of theory and practical skill, and nurses are required to generate and develop knowledge through implementing research into clinical practice. Considerable number of barriers could hind implementing research findings into practice. Barriers to research utilisation are not identified in the…

  6. Creating a Research Agenda and Setting Research Priorities for Clinical Nurse Specialists.

    Science.gov (United States)

    Foster, Jan; Bautista, Cynthia; Ellstrom, Kathleen; Kalowes, Peggy; Manning, Jennifer; Pasek, Tracy Ann

    The purpose of this article is to describe the evolution and results of the process for establishing a research agenda and identification of research priorities for clinical nurse specialists, approved by the National Association of Clinical Nurse Specialists (NACNS) membership and sanctioned by the NACNS Board of Directors. Development of the research agenda and identification of the priorities were an iterative process and involved a review of the literature; input from multiple stakeholders, including individuals with expertise in conducting research serving as task force members, and NACNS members; and feedback from national board members. A research agenda, which is to provide an enduring research platform, was established and research priorities, which are to be applied in the immediate future, were identified as a result of this process. Development of a research agenda and identification of research priorities are a key method of fulfilling the mission and goals of NACNS. The process and outcomes are described in this article.

  7. Evolution of Clinical Proteomics and its Role in Medicine | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    NCI's Office of Cancer Clinical Proteomics Research authored a review of the current state of clinical proteomics in the peer-reviewed Journal of Proteome Research. The review highlights outcomes from the CPTC program and also provides a thorough overview of the different technologies that have pushed the field forward. Additionally, the review provides a vision for moving the field forward through linking advances in genomic and proteomic analysis to develop new, molecularly targeted interventions.

  8. Alternative medicine research in clinical practice: a US national survey.

    Science.gov (United States)

    Tilburt, Jon C; Curlin, Farr A; Kaptchuk, Ted J; Clarridge, Brian; Bolcic-Jankovic, Dragana; Emanuel, Ezekiel J; Miller, Franklin G

    2009-04-13

    Little is known about whether federally funded complementary and alternative medicine (CAM) research is translating into clinical practice. We sought to describe the awareness of CAM clinical trials, the ability to interpret research results, the acceptance of research evidence, and the predictors of trial awareness among US clinicians. We conducted a cross-sectional mailed survey of 2400 practicing US acupuncturists, naturopaths, internists, and rheumatologists. A total of 1561 clinicians (65%) responded. Of the respondents, 59% were aware of at least 1 major CAM clinical trial; only 23% were aware of both trials. A minority of acupuncturists (20%), naturopaths (25%), internists (17%), and rheumatologists (33%) were "very confident" in interpreting research results (P research experience (OR, 1.45 [95% CI, 1.13-1.86]), institutional or academic practice setting (ORs, 1.98 [95% CI, 1.01-3.91], and 1.23 [95% CI, 0.73-2.09], respectively), and rating randomized trials as "very useful" (OR, 1.46 [95% CI, 1.12-1.91]) (P clinical decision making were positively associated with CAM trial awareness. Acupuncturists, naturopaths, and internists (ORs, 0.15 [95% CI, 0.10-0.23], 0.15 [95% CI, 0.09-0.24], and 0.18 [95% CI, 0.12-0.28], respectively) were all similarly less aware of CAM trial results compared with rheumatologists. For clinical research in CAM to achieve its social value, concerted efforts must be undertaken to train clinicians and improve the dissemination of research results.

  9. Integrating data to facilitate clinical research: a case study

    Directory of Open Access Journals (Sweden)

    Ilana Ackerman

    2005-12-01

    Full Text Available The integration of routine clinical administrative activities into ongoing rigorous clinical research poses challenges for both clinicians and researchers. This case study describes the development of a responsive database system used to facilitate comprehensive longitudinal research into the outcomes of patients waiting for hip and knee replacement surgery in a large public teaching hospital. The initial research procedure was paper-based, with manual patient matching and data entry. This process was time-consuming and associated with substantial risk of error and omissions, necessitating the design of a better system. An integrated database system was designed to receive daily electronic updates of the orthopaedic waiting-list and scheduled clinic and surgery dates. Using readily available software (Microsoft Access, new patients were identified through specifying inclusion and exclusion criteria which allowed rapid and complete recruitment at time of entry to the waiting-list. The integrated system specified the appropriate timing of multiple follow-up assessments, provided prompt information on recruitment for reporting purposes and integrated multiple linked research projects within one database. Seamless exporting of data to statistical programs for analysis was also enabled. This simple integrated approach facilitated efficient execution of a longitudinal study from recruitment to statistical analysis while maximising confidentiality and minimising resources required. This case study describes the development and design of a simple system which could be easily adapted for database management in hospital or clinic-based settings according to local requirements.

  10. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.

    Science.gov (United States)

    Cooper, Cindy; O'Cathain, Alicia; Hind, Danny; Adamson, Joy; Lawton, Julia; Baird, Wendy

    2014-07-01

    The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs. Copyright © 2014. Published by Elsevier Inc.

  11. Discovering Potential Correlations via Hypercontractivity

    Science.gov (United States)

    Kim, Hyeji; Gao, Weihao; Kannan, Sreeram; Oh, Sewoong; Viswanath, Pramod

    2017-11-01

    Discovering a correlation from one variable to another variable is of fundamental scientific and practical interest. While existing correlation measures are suitable for discovering average correlation, they fail to discover hidden or potential correlations. To bridge this gap, (i) we postulate a set of natural axioms that we expect a measure of potential correlation to satisfy; (ii) we show that the rate of information bottleneck, i.e., the hypercontractivity coefficient, satisfies all the proposed axioms; (iii) we provide a novel estimator to estimate the hypercontractivity coefficient from samples; and (iv) we provide numerical experiments demonstrating that this proposed estimator discovers potential correlations among various indicators of WHO datasets, is robust in discovering gene interactions from gene expression time series data, and is statistically more powerful than the estimators for other correlation measures in binary hypothesis testing of canonical examples of potential correlations.

  12. Journal Clubs: Engaging Clinical Nurses and Midwives in Research.

    Science.gov (United States)

    Cooper, Alannah L; Brown, Janie A

    2018-03-01

    It is essential that nurses and midwives can understand and critically evaluate research to ensure the delivery of high-quality evidence-based care. Journal clubs are an educational method that helps to develop research capacity and assist with bridging the gap between research and clinical practice. To maintain competence and remain current with the latest evidence, a commitment to continuing professional education is required. This article describes how a successful journal club led to clinical nurses identifying a gap in their own practice, which resulted in a research project being conducted by the members of the journal club. J Contin Educ Nurs. 2018;49(3):141-144. Copyright 2018, SLACK Incorporated.

  13. Reproducibility of clinical research in critical care: a scoping review.

    Science.gov (United States)

    Niven, Daniel J; McCormick, T Jared; Straus, Sharon E; Hemmelgarn, Brenda R; Jeffs, Lianne; Barnes, Tavish R M; Stelfox, Henry T

    2018-02-21

    The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies. We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals. To identify relevant clinical practices, we searched the New England Journal of Medicine, The Lancet, and JAMA for randomized trials published up to April 2016. To identify a comprehensive set of studies for these practices, included articles informed secondary searches within other high-impact medical and specialty journals. We included late-phase randomized controlled trials examining therapeutic clinical practices in adults admitted to general medical-surgical or specialty intensive care units (ICUs). Included articles were classified using a reproducibility framework. An original study was the first to evaluate a clinical practice. A reproduction attempt re-evaluated that practice in a new set of participants. Overall, 158 practices were examined in 275 included articles. A reproduction attempt was identified for 66 practices (42%, 95% CI 33-50%). Original studies reported larger effects than reproduction attempts (primary endpoint, risk difference 16.0%, 95% CI 11.6-20.5% vs. 8.4%, 95% CI 6.0-10.8%, P = 0.003). More than half of clinical practices with a reproduction attempt demonstrated effects that were inconsistent with the original study (56%, 95% CI 42-68%), among which a large number were reported to be efficacious in the original study and to lack efficacy in the reproduction attempt (34%, 95% CI 19-52%). Two practices reported to be efficacious in the original study were found to be harmful in the reproduction attempt. A minority of critical care practices with research published

  14. Clinical and Outcome Research in oncology The need for integration

    Directory of Open Access Journals (Sweden)

    Apolone Giovanni

    2003-04-01

    Full Text Available Abstract Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research (OR, defined as the discipline that describes, interprets, and predicts the impact of various influences, especially interventions, on final endpoints (from survival to satisfaction with care that matter to decision makers (from patients to society at large, with special emphasis on the use of patient-reported outcomes (PRO. Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but quite common circumstances, single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this context, the faster approval process may lead to drugs being marketed without there being a complete picture of how effective or safe they are. The FDA move to speed up drug approval, together with the use of not fully validated surrogate endpoints, give OR the unique opportunity to help understand the value of drugs that have received accelerated approval. Despite this opportunity, OR has yet to demonstrate its role in this specific setting and provide proof of the validity, reliability and added value of its primary endpoint measures when evaluated in a broader context. The implementation of lines of OR in the development and evaluation of anti-cancer drugs hinges upon

  15. Global Health and Emergency Care: Defining Clinical Research Priorities.

    Science.gov (United States)

    Hansoti, Bhakti; Aluisio, Adam R; Barry, Meagan A; Davey, Kevin; Lentz, Brian A; Modi, Payal; Newberry, Jennifer A; Patel, Melissa H; Smith, Tricia A; Vinograd, Alexandra M; Levine, Adam C

    2017-06-01

    Despite recent strides in the development of global emergency medicine (EM), the field continues to lag in applying a scientific approach to identifying critical knowledge gaps and advancing evidence-based solutions to clinical and public health problems seen in emergency departments (EDs) worldwide. Here, progress on the global EM research agenda created at the 2013 Academic Emergency Medicine Global Health and Emergency Care Consensus Conference is evaluated and critical areas for future development in emergency care research internationally are identified. A retrospective review of all studies compiled in the Global Emergency Medicine Literature Review (GEMLR) database from 2013 through 2015 was conducted. Articles were categorized and analyzed using descriptive quantitative measures and structured data matrices. The Global Emergency Medicine Think Tank Clinical Research Working Group at the Society for Academic Emergency Medicine 2016 Annual Meeting then further conceptualized and defined global EM research priorities utilizing consensus-based decision making. Research trends in global EM research published between 2013 and 2015 show a predominance of observational studies relative to interventional or descriptive studies, with the majority of research conducted in the inpatient setting in comparison to the ED or prehospital setting. Studies on communicable diseases and injury were the most prevalent, with a relative dearth of research on chronic noncommunicable diseases. The Global Emergency Medicine Think Tank Clinical Research Working Group identified conceptual frameworks to define high-impact research priorities, including the traditional approach of using global burden of disease to define priorities and the impact of EM on individual clinical care and public health opportunities. EM research is also described through a population lens approach, including gender, pediatrics, and migrant and refugee health. Despite recent strides in global EM research and

  16. Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis.

    Science.gov (United States)

    Ross, Joseph S

    2016-09-20

    The International Committee of Medical Journal Editors (ICMJE) recently announced a bold step forward to require data generated by interventional clinical trials that are published in its member journals to be responsibly shared with external investigators. The movement toward a clinical research culture that supports data sharing has important implications for the design, conduct, and reporting of systematic reviews and meta-analyses. While data sharing is likely to enhance the science of evidence synthesis, facilitating the identification and inclusion of all relevant research, it will also pose key challenges, such as requiring broader search strategies and more thorough scrutiny of identified research. Furthermore, the adoption of data sharing initiatives by the clinical research community should challenge the community of researchers involved in evidence synthesis to follow suit, including the widespread adoption of systematic review registration, results reporting, and data sharing, to promote transparency and enhance the integrity of the research process.

  17. Bulls and bears: the stock market and clinical pathology research.

    Science.gov (United States)

    Khong, T Y

    2009-09-01

    To analyse the level of funded research in clinical pathology in a recent bear and bull market to act as a predictor for future funding during the current global financial crisis. The level of funding for research published in three clinical pathology journals in 2005 and 2008 to coincide with the bear market of March 2000 to October 2002 and with the subsequent bull market to October 2007 was determined using a Medline query. Other parameters examined were the type of article, affiliation of the first author and the pathology subspecialty. Approximately 30% of publications were funded and did not differ between the 2 years studied. Original research papers were more likely to be funded than case reports or reviews. Research from university departments of pathology was more likely to be funded than from hospital pathology departments but there were more publications from hospital pathology departments. The proportion of research in the different subspecialties that was funded did not differ significantly between each other and between 2005 and 2008. Based on data from the previous bear market, which was the longest and deepest of the post 1950 era, and the subsequent bull market, which led to the all-time high in the Dow Jones Industrial Index, funding for clinical pathology research does not seem to be affected by bull or bear markets.

  18. Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

    Science.gov (United States)

    Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso

    2004-03-01

    The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals

  19. Digital pathology in nephrology clinical trials, research, and pathology practice.

    Science.gov (United States)

    Barisoni, Laura; Hodgin, Jeffrey B

    2017-11-01

    In this review, we will discuss (i) how the recent advancements in digital technology and computational engineering are currently applied to nephropathology in the setting of clinical research, trials, and practice; (ii) the benefits of the new digital environment; (iii) how recognizing its challenges provides opportunities for transformation; and (iv) nephropathology in the upcoming era of kidney precision and predictive medicine. Recent studies highlighted how new standardized protocols facilitate the harmonization of digital pathology database infrastructure and morphologic, morphometric, and computer-aided quantitative analyses. Digital pathology enables robust protocols for clinical trials and research, with the potential to identify previously underused or unrecognized clinically useful parameters. The integration of digital pathology with molecular signatures is leading the way to establishing clinically relevant morpho-omic taxonomies of renal diseases. The introduction of digital pathology in clinical research and trials, and the progressive implementation of the modern software ecosystem, opens opportunities for the development of new predictive diagnostic paradigms and computer-aided algorithms, transforming the practice of renal disease into a modern computational science.

  20. Ethical aspect of the clinical research. Informed consent in the clinical research for heavy ion radiotherapy of cancer

    International Nuclear Information System (INIS)

    Murata, Hajime

    2003-01-01

    The research center for heavy ion therapy of cancer was decided to be built in 1984 as a part of the national 10-year anticancer campaign, and construction of Heavy Ion Medical Accelerator in Chiba (HIMAC) was completed at the National Institute of Radiological Sciences in 1993. The HIMAC is the first heavy ion accelerator for only medical use in the world, and the clinical research of cancer radiotherapy was begun in 1994 using carbon ion generated by HIMAC. The purposes of the clinical research are to evaluate the safety and usefulness of carbon ion for cancer treatment, and to establish carbon ion therapy as a new and valuable tool for cancer therapy. Therefore, to obtain exact data in ethical aspect as well as scientific aspect of the clinical research, many special committees have been organized like as the committees of protocol planning for each organ, clinical study groups for each organ, evaluating committee of clinical data, and the ethical committee. Each clinical research is performed according to the research protocol of each organ, in which study purpose, rationale, patient condition, end-point of the study, adverse reaction are described. The document of informed consent (IC) contains study purpose, patient condition, method, predicted effect and demerit, protection of privacy, etc.. IC to each patient is done precisely by the doctor, and the freely-given IC of the patient is obtained. After the IC was completed, judgement of propriety for carbon ion therapy is done by the ethical committee for IC of each patient. Since 1994 carbon ion therapy has been performed over 1300 patients with cancer in various organs, and its safety and usefulness for cancer treatment has been clarified gradually. The carbon ion therapy is thought to be a new and promising tool for cancer treatment near future. (authors)

  1. Data management in clinical research: Synthesizing stakeholder perspectives.

    Science.gov (United States)

    Johnson, Stephen B; Farach, Frank J; Pelphrey, Kevin; Rozenblit, Leon

    2016-04-01

    This study assesses data management needs in clinical research from the perspectives of researchers, software analysts and developers. This is a mixed-methods study that employs sublanguage analysis in an innovative manner to link the assessments. We performed content analysis using sublanguage theory on transcribed interviews conducted with researchers at four universities. A business analyst independently extracted potential software features from the transcriptions, which were translated into the sublanguage. This common sublanguage was then used to create survey questions for researchers, analysts and developers about the desirability and difficulty of features. Results were synthesized using the common sublanguage to compare stakeholder perceptions with the original content analysis. Individual researchers exhibited significant diversity of perspectives that did not correlate by role or site. Researchers had mixed feelings about their technologies, and sought improvements in integration, interoperability and interaction as well as engaging with study participants. Researchers and analysts agreed that data integration has higher desirability and mobile technology has lower desirability but disagreed on the desirability of data validation rules. Developers agreed that data integration and validation are the most difficult to implement. Researchers perceive tasks related to study execution, analysis and quality control as highly strategic, in contrast with tactical tasks related to data manipulation. Researchers have only partial technologic support for analysis and quality control, and poor support for study execution. Software for data integration and validation appears critical to support clinical research, but may be expensive to implement. Features to support study workflow, collaboration and engagement have been underappreciated, but may prove to be easy successes. Software developers should consider the strategic goals of researchers with regard to the

  2. Encouraging primary care research: evaluation of a one-year, doctoral clinical epidemiology research course.

    Science.gov (United States)

    Liira, Helena; Koskela, Tuomas; Thulesius, Hans; Pitkälä, Kaisu

    2016-01-01

    Research and PhDs are relatively rare in family medicine and primary care. To promote research, regular one-year research courses for primary care professionals with a focus on clinical epidemiology were started. This study explores the academic outcomes of the first four cohorts of research courses and surveys the participants' perspectives on the research course. An electronic survey was sent to the research course participants. All peer-reviewed scientific papers published by these students were retrieved by literature searches in PubMed. Primary care in Finland. A total of 46 research course participants who had finished the research courses between 2007 and 2012. Of the 46 participants 29 were physicians, eight nurses, three dentists, four physiotherapists, and two nutritionists. By the end of 2014, 28 of the 46 participants (61%) had published 79 papers indexed in PubMed and seven students (15%) had completed a PhD. The participants stated that the course taught them critical thinking, and provided basic research knowledge, inspiration, and fruitful networks for research. A one-year, multi-professional, clinical epidemiology based research course appeared to be successful in encouraging primary care research as measured by research publications and networking. Activating teaching methods, encouraging focus on own research planning, and support from peers and tutors helped the participants to embark on research projects that resulted in PhDs for 15% of the participants. Clinical research and PhDs are rare in primary care in Finland, which has consequences for the development of the discipline and for the availability of clinical lecturers at the universities. A clinical epidemiology oriented, one-year research course increased the activity in primary care research. Focus on own research planning and learning the challenges of research with peers appeared to enhance the success of a doctoral research course. A doctoral research course encouraged networking, and

  3. Trials and tribulations of clinical research teaching and training

    Directory of Open Access Journals (Sweden)

    Ravindra B Ghooi

    2010-01-01

    Full Text Available Clinical research institutions have mushroomed in the country, though there is a generalized lack of experienced faculty. These institutes mostly confine themselves to theoretical aspects of clinical research, since there is lack of facilities for practical training. Students passing out of these institutes often find it difficult to get decent jobs and salaries at the entry level in the industry are poor. Poor placements of graduating students become major barriers for attracting quality students to the courses. This in turn affects the quality of people that the industry requires, in order to ensure a high growth rate of the industry. The industry, in addition to facing a severe crunch of high quality professionals, is also suffering from attrition that is a common feature. This attrition stems from, inter alia the industry′s demand for experienced people at the entry level. To improve overall standards of professionals entering clinical research, institutes and the industry need to get together and work in close co-operation. The industry and the institutes need to take positive steps if recent trends have to be reversed and clinical research as a whole has to move to a higher level. This article is based on the perceptions of the author, about the problems faced and offers some suggestions. Though these perceptions represent the reality, it is difficult to provide hard evidence that they do so.

  4. Evaluation of clinical research reporting in African Journal of ...

    African Journals Online (AJOL)

    Background: Clinical research forms the cornerstone of efforts to improve the lives of patients. African Journal of Paediatric Surgery has been a major vehicle for dissemination of information to paediatric surgeons in Africa since 2004. Most studies in the paediatric surgical literature are observational studies. This study aims ...

  5. Handling categories properly: a novel objective of clinical research

    NARCIS (Netherlands)

    Cleophas, Ton J.; Atiqi, Roya; Zwinderman, Aeilko H.

    2012-01-01

    A major objective of clinical research is to study outcome effects in subgroups. Such effects generally have stepping functions that are not strictly linear. Analyzing stepping functions in linear models thus raises the risk of underestimating the effects. In the past few years, recoding subgroup

  6. The Microcomputer in the Clinical Nursing Research Unit

    OpenAIRE

    Schwirian, Patricia M.; Byers, Sandra R.

    1982-01-01

    This paper discusses the microcomputer in clinical nursing research. There are six general areas in which computers have been useful to nurses: nursing notes and charting; patient care plans; automated monitoring of high-tech nursing units; HIS and MIS systems; personnel distribution systems; and education.

  7. A pragmatic analysis of vulnerability in clinical research.

    Science.gov (United States)

    Wendler, David

    2017-09-01

    Identifying which subjects are vulnerable, and implementing safeguards to protect them, is widely regarded as essential to clinical research. Commentators have endorsed a number of responses to these challenges and have thereby made significant progress in understanding vulnerability in clinical research. At the same time, this literature points to a central contradiction which calls into question its potential to protect vulnerable subjects in practice. Specifically, analysis suggests that all human subjects are vulnerable and vulnerability in clinical research is comparative and context dependent, in the sense that individuals are vulnerable relative to others and in some contexts only. Yet, if everyone is vulnerable, there seems to be no point in citing the vulnerability of some individuals. Moreover, the conclusion that everyone is vulnerable seems inconsistent with the claims that vulnerability is comparative and context dependent, raising concern over whether it will be possible to develop a comprehensive account of vulnerability that is internally consistent. The solution to this dilemma lies in recognition of the fact that the practical significance of claims regarding vulnerability depends on the context in which they are used. The claims that appear to lead to the central contradiction are in fact accurate conclusions that follow from different uses of the term 'vulnerability'. The present manuscript describes this 'pragmatic' approach to vulnerability in clinical research and considers its implications for ensuring that subjects receive appropriate protection. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  8. Core outcome sets for research and clinical practice

    NARCIS (Netherlands)

    Chiarotto, Alessandro; Ostelo, Raymond W.; Turk, Dennis C.; Buchbinder, Rachelle; Boers, Maarten

    2017-01-01

    Background This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. Method A core outcome set is a minimum consensus-based set of outcomes that should be

  9. Research: Clinical electives at the University of Michigan from the ...

    African Journals Online (AJOL)

    Research: Clinical electives at the University of Michigan from the perspective of Ghanaian medical students: A qualitative study. ... The 60- to 90-minute interviews were audio-recorded and transcribed verbatim, and transcripts were coded by three investigators in an iterative process of thematic identification, codebook ...

  10. Fair Inclusion of Pregnant Women in Clinical Research

    NARCIS (Netherlands)

    van der Zande, I.S.E.|info:eu-repo/dai/nl/413994279

    2017-01-01

    Background: There has always been a reluctance to include pregnant women in clinical research, due to a fear of harm to the foetus. At the same time, there is a need for evidence-based information on medications and treatments for pregnant women who are or become ill during their pregnancy, which

  11. Building Networks for Global Clinical Research: The Basics.

    Science.gov (United States)

    Shearer, David W; Volberding, Paul A; Schemitsch, Emil H; Cook, Gillian E; Slobogean, Gerard P; Morshed, Saam

    2015-12-01

    Over the last several decades, interest in global health across all fields of medicine, including orthopaedic surgery, has grown markedly. Cross-national collaborations are an effective means of conducting high-quality clinical research and offer many advantages over single-center investigations. Successful collaboration requires a well-designed research protocol, development of an effective team structure, and the funding to ensure the project is sustained to completion. Equally important, investigators must consider the social, linguistic, and cultural context in which the study is being undertaken. Although randomized clinical trials are the highest level of evidence, study designs may have to be adapted to accommodate available resources, expertise, and local contextual factors. With appropriate planning, these collaborative endeavors can generate changes in clinical practice and positively impact health policy.

  12. Patient involvement in clinical research: why, when, and how

    Directory of Open Access Journals (Sweden)

    Sacristán JA

    2016-04-01

    Full Text Available José A Sacristán,1 Alfonso Aguarón,2 Cristina Avendaño-Solá,3 Pilar Garrido,4 Juan Carrión,5 Alipio Gutiérrez,6 Robert Kroes,7 Angeles Flores11Medical Department, Lilly Spain, 2Myeloma Patients Europe, 3Research Ethics Committee, University Hospital Puerta de Hierro, 4Oncology Department, Hospital Ramón y Cajal, 5FEDER (Spanish Federation for Rare Diseases, 6National Association of Health Journalists, Madrid, Spain; 7Clinical Open Innovation, Lilly Europe, Amsterdam, the Netherlands Abstract: The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1 setting priorities, 2 study leadership and design, 3 improved access to clinical trials, 4 preparation and oversight of the information provided to participants, 5 post-study evaluation of the patient experience, and 6 the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient.Keywords: patients, research, clinical trials, bioethics, engagement

  13. Common Data Elements for Clinical Research in Friedreich Ataxia

    Science.gov (United States)

    Lynch, David R.; Pandolfo, Massimo; Schulz, Jorg B.; Perlman, Susan; Delatycki, Martin B.; Payne, R. Mark; Shaddy, Robert; Fischbeck, Kenneth H.; Farmer, Jennifer; Kantor, Paul; Raman, Subha V.; Hunegs, Lisa; Odenkirchen, Joanne; Miller, Kristy; Kaufmann, Petra

    2012-01-01

    Background To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich ataxia, a neurological disorder that involves multiple organ systems. Methods To develop Friedreich’s ataxia common data elements, Friedreich’s ataxia experts formed a working group and subgroups to define elements in: Ataxia and Performance Measures; Biomarkers; Cardiac and Other Clinical Outcomes; and Demographics, Laboratory Tests and Medical History. The basic development process included: Identification of international experts in Friedreich’s ataxia clinical research; Meeting via teleconference to develop a draft of standardized common data elements recommendations; Vetting of recommendations across the subgroups; Dissemination of recommendations to the research community for public comment. Results The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The Subgroups’ recommendations are classified as core, supplemental or exploratory. Template case report forms were created for many of the core tests. Conclusions The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new and ongoing studies will be assessed in an ongoing fashion to define their utility in Friedreich’s ataxia. PMID:23239403

  14. Clinical Application of Neuroplastic Brain Research in Eating Disorder Treatment

    Directory of Open Access Journals (Sweden)

    Abigail H. Natenshon

    2016-12-01

    Neurophysiological and psychophysiological treatment interventions, by carving new neuronal pathways and creating connectivity that augments brain circuitry, carry the potential to remediate body image and self-image distortions, reintegrating the fragmented eating disordered core self. To date, intentional partnering between therapist, ED patient, and neuroplastic brain has been rarely applied in the clinical milieu and minimally referenced in the treatment literature. By bringing current neuroplasticity research into frontline practice, ED practitioners not only bridge the research/practice gap, but redefine new directions for future ED research.

  15. Regulatory Framework for Conducting Clinical Research in Canada.

    Science.gov (United States)

    Alas, Josmar K; Godlovitch, Glenys; Mohan, Connie M; Jelinski, Shelly A; Khan, Aneal A

    2017-09-01

    Research in human subjects is at the core of achieving improvements in health outcomes. For clinical trials, in addition to the peer review of the results before publication, it is equally important to consider whether the trial will be conducted in a manner that generates data of the highest quality and provides a measure of safety for the participating subjects. In Canada, there is no definitive legislation that governs the conduct of research involving human subjects, but a network of regulations at different levels does provide a framework for both principal investigators and sponsors. In this paper, we provide an overview of the federal, provincial and institutional legislation, guidelines and policies that will inform readers about the requirements for clinical trial research. This includes a review of the role of the Food and Drug Regulations under the Food and Drugs Act and the Tri-Council Policy Statement (TCPS2), an overview of provincial legislation across the country, and a focus on selected policies from institutional research ethics boards and public health agencies. Many researchers may find navigation through regulations frustrating, and there is a paucity of information that explains the interrelationship between the different regulatory agencies in Canada. Better understanding the process, we feel, will facilitate investigators interested in clinical trials and also enhance the long-term health of Canadians.

  16. Bibliography of clinical research in malaysia: methods and brief results.

    Science.gov (United States)

    Teng, C L; Zuhanariah, M N; Ng, C S; Goh, C C

    2014-08-01

    This article describes the methodology of this bibliography. A search was conducted on the following: (1) bibliographic databases (PubMed, Scopus, and other databases) using search terms that maximize the retrieval of Malaysian publications; (2) Individual journal search of Malaysian healthrelated journals; (3) A targeted search of Google and Google Scholar; (4) Searching of Malaysian institutional repositories; (5) Searching of Ministry of Health and Clinical Research Centre website. The publication years were limited to 2000- 2013. The citations were imported or manually entered into bibliographic software Refworks. After removing duplicates, and correcting data entry errors, PubMed's Medical Subject Headings (MeSH terms) were added. Clinical research is coded using the definition "patient-oriented-research or research conducted with human subjects (or on material of human origin) for which the investigator directly interacts with the human subjects at some point during the study." A bibliography of citations [n=2056] that fit the criteria of clinical research in Malaysia in selected topics within five domains was generated: Cancers [589], Cardiovascular diseases [432], Infections [795], Injuries [142], and Mental Health [582]. This is done by retrieving citations with the appropriate MESH terms, as follow: For cancers (Breast Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms), for cardiovascular diseases (Coronary Disease; Hypertension; Stroke), for infections (Dengue; Enterovirus Infections, HIV Infections; Malaria; Nipah Virus; Tuberculosis), for injuries (Accidents, Occupational; Accidents, Traffic; Child Abuse; Occupational Injuries), for mental health (Depression; Depressive Disorder; Depressive Disorder, Major; Drug Users; Psychotic Disorders; Suicide; Suicide, Attempted; Suicidal Ideation; Substance- Related Disorders).

  17. Regulation of clinical research and bioethics in Portugal.

    Science.gov (United States)

    Carvalho, Fatima Lampreia

    2007-06-01

    This article presents an overview of the Portuguese transposition of the European Directive on Good Clinical Practice (2001/20/E) concerning scientific and academic debates on bioethics and clinical investigation. Since the Directive was transposed into Portuguese law by its National Assembly, the bureaucracy of clinical trials has been ever more complex. Despite demands for swift application processes by the Pharmaceutical industry, supported by the European Parliament, the Directive's transcription to the national law has not always delivered the expected outcome. However, this has led to an increased number of applications for clinical trials in Portuguese hospitals. In this article I revise bioethical publications and decree-laws enabling an informed appraisal of the anxieties and prospects for the implementation of the clinical trials Directive in Portugal. This article also places the European Directive in the field of sociology of bioethics, arguing that Portuguese bioethical institutions differ from those of the US, and also from Northern European counterparts. The main divergence is that those people in Portugal who claim expertise in 'legal' bioethics do not dominate either the bureaucratic structure of research or ethics committees for health. Even experts in the applied ethics field now claim that 'professional bioethicists do not exist'. The recent creation of a national Ethics Committee for Clinical Investigation (CEIC) in line with the European Directive on Good Clinical Practice (GCP) will not change the present imbalance between different professional jurisdictions in the national bioethical debate in Portugal.

  18. 59th Medical Wing Clinical Research Division Clinical Investigations Program Posters (Count: 2)

    Science.gov (United States)

    2017-05-08

    research or technical documents will not be forwarded to the 502 ISGIJAC legal office for an ethics rovlow. To assist you in making this decision...a legal ethics review is required. If you (as the author) or your supervisor check "YES" in block 17 of the Form 3039, your research or technical...SGVU SUBJECT: Professional Presentation Approval 18 APR 20 17 1. Your paper, entitled 591h Medical Wing Clinical Research Division Clin ical

  19. Use of altered informed consent in pragmatic clinical research.

    Science.gov (United States)

    McKinney, Ross E; Beskow, Laura M; Ford, Daniel E; Lantos, John D; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-10-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests. © The Author(s) 2015.

  20. Micro-mainframe-like personal clinical research system.

    Science.gov (United States)

    Odaka, T; Watanabe, Y; Moriguchi, S; Akazawa, K; Simada, M; Sakamoto, M; Kamakura, T; Nose, Y

    1991-06-01

    We constructed a micro-mainframe-link clinical research system for personal use (Personal Clinical Research System). This system was developed with both a mainframe computer and a personal computer (PC). The prepared programs included a database manager (on the mainframe computer), a user interface program (on the PC), and a communication control program that connected the mainframe computer with the PC. The database on the mainframe computer was constructed by two methods. The first method was to transmit data from the PC to the mainframe computer. The second method was to extract data from the patient information database. Using this system, a physician is able to construct a personal research database that contains interesting data for the physician. In addition, the physician is able to accumulate data on a special field using this system. A discharge summary system is now in operation as an example of this system.

  1. Ancillary Care: From Theory to Practice in International Clinical Research

    Science.gov (United States)

    Pratt, Bridget; Zion, Deborah; Lwin, Khin Maung; Cheah, Phaik Yeong; Nosten, Francois; Loff, Bebe

    2013-01-01

    How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger’s health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. Empirical research on the Shoklo Malaria Research Unit’s (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU’s dual role as a research unit and medical non-governmental organization. PMID:23864908

  2. The Ethics of Clinical Care and the Ethics of Clinical Research: Yin and Yang.

    Science.gov (United States)

    Kowalski, Charles J; Hutchinson, Raymond J; Mrdjenovich, Adam J

    2017-02-01

    The Belmont Report's distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  3. Clinical research in small genomically stratified patient populations.

    Science.gov (United States)

    Martin-Liberal, J; Rodon, J

    2017-07-01

    The paradigm of early drug development in cancer is shifting from 'histology-oriented' to 'molecularly oriented' clinical trials. This change can be attributed to the vast amount of tumour biology knowledge generated by large international research initiatives such as The Cancer Genome Atlas (TCGA) and the use of next generation sequencing (NGS) techniques developed in recent years. However, targeting infrequent molecular alterations entails a series of special challenges. The optimal molecular profiling method, the lack of standardised biological thresholds, inter- and intra-tumor heterogeneity, availability of enough tumour material, correct clinical trials design, attrition rate, logistics or costs are only some of the issues that need to be taken into consideration in clinical research in small genomically stratified patient populations. This article examines the most relevant challenges inherent to clinical research in these populations. Moreover, perspectives from the Academia point of view are reviewed as well as initiatives to be taken in forthcoming years. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. The Mid-South clinical Data Research Network.

    Science.gov (United States)

    Rosenbloom, S Trent; Harris, Paul; Pulley, Jill; Basford, Melissa; Grant, Jason; DuBuisson, Allison; Rothman, Russell L

    2014-01-01

    The Mid-South Clinical Data Research Network (CDRN) encompasses three large health systems: (1) Vanderbilt Health System (VU) with electronic medical records for over 2 million patients, (2) the Vanderbilt Healthcare Affiliated Network (VHAN) which currently includes over 40 hospitals, hundreds of ambulatory practices, and over 3 million patients in the Mid-South, and (3) Greenway Medical Technologies, with access to 24 million patients nationally. Initial goals of the Mid-South CDRN include: (1) expansion of our VU data network to include the VHAN and Greenway systems, (2) developing data integration/interoperability across the three systems, (3) improving our current tools for extracting clinical data, (4) optimization of tools for collection of patient-reported data, and (5) expansion of clinical decision support. By 18 months, we anticipate our CDRN will robustly support projects in comparative effectiveness research, pragmatic clinical trials, and other key research areas and have the capacity to share data and health information technology tools nationally. 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.

  5. Clinical research of traditional Chinese medicine in big data era.

    Science.gov (United States)

    Zhang, Junhua; Zhang, Boli

    2014-09-01

    With the advent of big data era, our thinking, technology and methodology are being transformed. Data-intensive scientific discovery based on big data, named "The Fourth Paradigm," has become a new paradigm of scientific research. Along with the development and application of the Internet information technology in the field of healthcare, individual health records, clinical data of diagnosis and treatment, and genomic data have been accumulated dramatically, which generates big data in medical field for clinical research and assessment. With the support of big data, the defects and weakness may be overcome in the methodology of the conventional clinical evaluation based on sampling. Our research target shifts from the "causality inference" to "correlativity analysis." This not only facilitates the evaluation of individualized treatment, disease prediction, prevention and prognosis, but also is suitable for the practice of preventive healthcare and symptom pattern differentiation for treatment in terms of traditional Chinese medicine (TCM), and for the post-marketing evaluation of Chinese patent medicines. To conduct clinical studies involved in big data in TCM domain, top level design is needed and should be performed orderly. The fundamental construction and innovation studies should be strengthened in the sections of data platform creation, data analysis technology and big-data professionals fostering and training.

  6. Defining Research: The Effect of Linguistic Choices on the Intentions to Participate in Clinical Research.

    Science.gov (United States)

    Strekalova, Yulia A

    2017-06-01

    Significant barriers to participant recruitment for clinical research (CR) are related to effective communication, and nurse coordinators are entrusted with being knowledge brokers between investigators and prospective participants. This prospective cohort study sought to identify linguistic choices that could inform and facilitate recruitment efforts. Healthy adults ( N = 204) were invited to join an online survey to assess the likelihood of participation in CR based on short and extended definitions of CR. Five short definitions included clinical trial, clinical study, health-related research study, community participatory study, and quality improvement study. The likelihood of participation in CR was the lowest for clinical trial and the highest for health-related research study. However, when only an extended definition was provided, those differences were not observed. A linguistic change from trial to study could lead to positive attitude toward CR and improvements in recruitment. However, ethical implications of linguistic choices should be considered.

  7. Highlights of the 2012 research workshop: Using nutrigenomics and metabolomics in clinical nutrition research

    Science.gov (United States)

    The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Research Workshop, "Using Nutrigenomics and Metabolomics in Clinical Nutrition Research," was held on January 21, 2012, in Orlando, Florida. The conference brought together experts in human nutrition who use nutrigenomic and meta...

  8. Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

    Science.gov (United States)

    Wehrlen, Leslie; Krumlauf, Mike; Ness, Elizabeth; Maloof, Damiana; Bevans, Margaret

    2016-05-01

    Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings. Published by Elsevier Inc.

  9. The clinical research office of the endourological society audit committee.

    Science.gov (United States)

    Preminger, Glenn M; Alken, Peter; Habuchi, Tomonori; Wijkstra, Hessel; Skolarikos, Andreas; Yin, Chan-Jun

    2011-11-01

    The Clinical Research Office of the Endourological Society (CROES) conducts large-scale, international, multicenter clinical trials in the field of endourology. One of the major challenges that these trials pose is to ensure that data collected remotely and online within a very short time frame are valid and reliable. This editorial describes a formal process for auditing the data by the CROES Audit Committee. The audit process presented is largely based on an automatic scoring system, which takes into consideration several parameters to determine the quality of the data and of the participating institution. This process is dynamic in nature and offers live monitoring of both patient data and study centers.

  10. Big Data Clinical Research: Validity, Ethics, and Regulation.

    Science.gov (United States)

    Balas, E Andrew; Vernon, Marlo; Magrabi, Farah; Gordon, Lynne Thomas; Sexton, Joanne

    2015-01-01

    Electronic Health Records (EHR) promise improvement for patient care and also offer great value for biomedical research including clinical, public health, and health services research. Unfortunately, the full potential of EHR big data research has remained largely unrealized. The purpose of this study was to identify rate limiting factors, and develop recommendations to better balance unrestricted extramural EHR access with legitimate safeguarding of EHR data in retrospective research. By exploring primary, secondary, and tertiary sources, this review identifies external constraints and provides a comparative analysis of social influencers in retrospective EHR-based research. Results indicate that EHRs have the advantage of reflecting the reality of patient care but also show a frequency of between 4.3-86% of incomplete and inaccurate data in various fields. The rapid spread of alternative analytics for health data challenges traditional interpretations of confidentiality protections. A confusing multiplicity of controls creates barriers to big data EHR research. More research on the use of EHR big data is likely to improve accuracy and validity. Information governance and research approval processes should be simplified. Comprehensive regulatory policies that do not exclusively cover health care entities, are needed. Finally, new computing safeguards are needed to address public concerns, like research access only to aggregate data and not to individually identifiable information.

  11. Revisioning Clinical Psychology: Integrating Cultural Psychology into Clinical Research and Practice with Portuguese Immigrants

    OpenAIRE

    James, Susan; Harris, Sara; Foster, Gary; Clarke, Juanne; Gadermann, Anne; Morrison, Marie; Bezanson, Birdie Jane

    2013-01-01

    This article outlines a model for conducting psychotherapy with people of diverse cultural backgrounds. The theoretical foundation for the model is based on clinical and cultural psychology. Cultural psychology integrates psychology and anthropology in order to provide a complex understanding of both culture and the individual within his or her cultural context. The model proposed in this article is also based on our clinical experience and mixed method research with the Portuguese communi...

  12. Ethics and epistemology of accurate prediction in clinical research.

    Science.gov (United States)

    Hey, Spencer Phillips

    2015-07-01

    All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research. 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.

  13. Integrating historical clinical and financial data for pharmacological research

    Directory of Open Access Journals (Sweden)

    Deshmukh Vikrant G

    2011-11-01

    Full Text Available Abstract Background Retrospective research requires longitudinal data, and repositories derived from electronic health records (EHR can be sources of such data. With Health Information Technology for Economic and Clinical Health (HITECH Act meaningful use provisions, many institutions are expected to adopt EHRs, but may be left with large amounts of financial and historical clinical data, which can differ significantly from data obtained from newer systems, due to lack or inconsistent use of controlled medical terminologies (CMT in older systems. We examined different approaches for semantic enrichment of financial data with CMT, and integration of clinical data from disparate historical and current sources for research. Methods Snapshots of financial data from 1999, 2004 and 2009 were mapped automatically to the current inpatient pharmacy catalog, and enriched with RxNorm. Administrative metadata from financial and dispensing systems, RxNorm and two commercial pharmacy vocabularies were used to integrate data from current and historical inpatient pharmacy modules, and the outpatient EHR. Data integration approaches were compared using percentages of automated matches, and effects on cohort size of a retrospective study. Results During 1999-2009, 71.52%-90.08% of items in use from the financial catalog were enriched using RxNorm; 64.95%-70.37% of items in use from the historical inpatient system were integrated using RxNorm, 85.96%-91.67% using a commercial vocabulary, 87.19%-94.23% using financial metadata, and 77.20%-94.68% using dispensing metadata. During 1999-2009, 48.01%-30.72% of items in use from the outpatient catalog were integrated using RxNorm, and 79.27%-48.60% using a commercial vocabulary. In a cohort of 16304 inpatients obtained from clinical systems, 4172 (25.58% were found exclusively through integration of historical clinical data, while 15978 (98% could be identified using semantically enriched financial data. Conclusions

  14. Computerized clinical guidelines: current status & principles for future research.

    Science.gov (United States)

    Kondylakis, Haridimos; Tsiknakis, Manolis

    2012-01-01

    Although it is widely accepted that the adoption of computerized clinical guidelines would improve the quality of the provided health care, their influence in the daily practice is limited. In this paper we provide insights on the core topics related to computer interpretable clinical guidelines and we present shortly the main approaches in the area. Then we discuss the current limitations, and we present three simple principles that according to our view should be adopted to enhance the penetration of computerized clinical guidelines in the health care organizations. The overall goal of this paper is not only to give readers a quick overview of the works in the area, but also to provide necessary insights for the practical understanding of the issues involved and draw directions for future research and development activities.

  15. Multisystemic Therapy(®) : Clinical Overview, Outcomes, and Implementation Research.

    Science.gov (United States)

    Henggeler, Scott W; Schaeffer, Cindy M

    2016-09-01

    Multisystemic therapy (MST) is an evidence-based treatment originally developed for youth with serious antisocial behavior who are at high risk for out-of-home placement and their families; and subsequently adapted to address other challenging clinical problems experience by youths and their families. The social-ecological theoretical framework of MST is presented as well as its home-based model of treatment delivery, defining clinical intervention strategies, and ongoing quality assurance/quality improvement system. With more than 100 peer-reviewed outcome and implementation journal articles published as of January 2016, the majority by independent investigators, MST is one of the most extensively evaluated family based treatments. Outcome research has yielded almost uniformly favorable results for youths and families, and implementation research has demonstrated the importance of treatment and program fidelity in achieving such outcomes. © 2016 Family Process Institute.

  16. The DSM and Professional Practice: Research, Clinical, and Institutional Perspectives.

    Science.gov (United States)

    Halpin, Michael

    2016-06-01

    How mental illnesses are defined has significant ramifications, given the substantial social and individual repercussions of these conditions. Using actor-network theory, I analyze how mental health professionals use the Diagnostic and Statistical Manual of Mental Disorders (DSM) in their work. Drawing on observations of a neuropsychological laboratory and interviews with 27 professionals (i.e., psychiatrists, psychologists), I investigate how the DSM is used in research, clinical, and institutional work. In research, the DSM influences study design and exclusion/inclusion criteria. In the clinic, the DSM influences how disorders are conceptualized and diagnosed. Institutionally, the DSM aligns the patient-professional encounter to insurance and pharmaceutical interests. I conclude that the DSM operates as multiple, context-specific taxonomies that pervasively influence professional practices, such that all possible actions must orient to DSM criteria, with professionals both a source and an object of institutionalized gaze. © American Sociological Association 2016.

  17. Single cell analysis contemporary research and clinical applications

    CERN Document Server

    Cossarizza, Andrea

    2017-01-01

    This book highlights the current state of the art in single cell analysis, an area that involves many fields of science – from clinical hematology, functional analysis and drug screening, to platelet and microparticle analysis, marine biology and fundamental cancer research. This book brings together an eclectic group of current applications, all of which have a significant impact on our current state of knowledge. The authors of these chapters are all pioneering researchers in the field of single cell analysis. The book will not only appeal to those readers more focused on clinical applications, but also those interested in highly technical aspects of the technologies. All of the technologies identified utilize unique applications of photon detection systems.

  18. Using levels of evidence to compare clinical impact from research.

    Science.gov (United States)

    Ahmad, Tashfeen; Chinoy, Muhammad Amin; Tayyab, Muhammad

    2014-02-01

    Impact of medical institutions on clinical decision-making globally might be estimated by the level of evidence of their research articles. The aim of this study was to compare levels of evidence of articles for Pakistan. We compared levels of evidence of articles from Pakistan, Nigeria, Japan, and the United States (U.S.). Majority (73%) of articles in U.S. general medical journals were high levels (1-2), while majority (66% to 95%) in Japanese, Nigerian, Pakistani, and sub-specialty U.S. journals were lower levels (3-4) (P evidence of articles across institutions might reflect relative potential of clinical impact, and might be useful for institutions, policy makers, and health research planners for priority setting. © 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

  19. Innovative designs for radiation oncology research in clinical trials

    International Nuclear Information System (INIS)

    Rubin, P.; Keys, H.; Salazar, O.

    1987-01-01

    The goals of the research mission are clear: (1) to explore in a logical, systematic, organized, and coordinated fashion those potential therapeutic advances that show promise; (2) to identify, in the laboratory, those models that predict successful combinations of treatment modes; (3) to search for ultimate treatment of programs that improve the therapeutic ratio. The modalities, innovations in treatment, and logic exist; it now rests with meticulous science to show carefully the directions that clinical research should follow in pursuit of the ultimate objective of improving cancer cure rates with less toxicity

  20. Essentials of apoptosis - A guide for basic and clinical research

    Directory of Open Access Journals (Sweden)

    CarloAlberto Redi

    2010-03-01

    Full Text Available Essentials of apoptosis - A guide for basic and clinical researchSecond edition, 2009. Xiao-Ming Yin and Zheng Dong (Eds; Humana press, Totowa, New Jersey (USA Pages: 730; €92.95; ISBN: 978-1-60327-380-0When a book get a second edition in a six-year period, it means that the usually employed words praising the unbounded qualities of the underselling book (a key technical reference; comprehensive and cutting-edge; for beginners and experienced researchers; step-by-step readily reproducible protocols; notes on troubleshooting and avoiding known pitfalls; etc. etc. have been checked by the scientific comunity...

  1. Trends in clinical reproductive medicine research: 10 years of growth.

    Science.gov (United States)

    Aleixandre-Benavent, Rafael; Simon, Carlos; Fauser, Bart C J M

    2015-07-01

    To study the most important metrics of publication in the field of reproductive medicine over the decade 2003-2012 to aid in discerning the clinical, social, and epidemiologic implications of this relatively new but rapidly emerging area in medical sciences. Bibliometric analysis of most-cited publications from Web of Science databases. Not applicable. None. None. Most productive and frequently cited investigators, institutions, and countries and specific areas of research, scientific collaborations, and comparison of the growth of reproductive medicine research compared with other areas of medical investigation such as obstetrics and gynecology and related science categories. We found that 90 investigators with more than 1,000 citations had jointly published 4,010 articles. A continued rise in the impact factor of reproductive medicine journals was seen. The number of publications in reproductive medicine grew more rapidly compared with other science categories. Presently 22% of highly cited articles in reproductive medicine research are published in journals belonging to science categories outside reproductive medicine. The most-cited study groups are situated in the Netherlands, Belgium, Spain, the United States, and the United Kingdom, and collaborative studies have been increasing. Reproductive medicine research and subsequent clinical development have attained scientific growth and maturity. High-quality research is increasingly being published in high-impact journals. The increase in (inter)national collaborations seems to be key to the field's success. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  2. Integrated and Gender-Affirming Transgender Clinical Care and Research

    Science.gov (United States)

    Radix, Asa; Deutsch, Madeline B.

    2016-01-01

    Abstract: Transgender (trans) communities worldwide, particularly those on the trans feminine spectrum, are disproportionately burdened by HIV infection and at risk for HIV acquisition/transmission. Trans individuals represent an underserved, highly stigmatized, and under-resourced population not only in HIV prevention efforts but also in delivery of general primary medical and clinical care that is gender affirming. We offer a model of gender-affirmative integrated clinical care and community research to address and intervene on disparities in HIV infection for transgender people. We define trans terminology, briefly review the social epidemiology of HIV infection among trans individuals, highlight gender affirmation as a key social determinant of health, describe exemplar models of gender-affirmative clinical care in Boston MA, New York, NY, and San Francisco, CA, and offer suggested “best practices” for how to integrate clinical care and research for the field of HIV prevention. Holistic and culturally responsive HIV prevention interventions must be grounded in the lived realities the trans community faces to reduce disparities in HIV infection. HIV prevention interventions will be most effective if they use a structural approach and integrate primary concerns of transgender people (eg, gender-affirmative care and management of gender transition) alongside delivery of HIV-related services (eg, biobehavioral prevention, HIV testing, linkage to care, and treatment). PMID:27429189

  3. Hypnotic illusions and clinical delusions: hypnosis as a research method.

    Science.gov (United States)

    Cox, Rochelle E; Barnier, Amanda J

    2010-01-01

    Hypnosis is not only intrinsically interesting, but it can be used instrumentally as a powerful tool to investigate phenomena outside its immediate domain. In focusing on instrumental hypnosis research, we first sketch the many contributions of hypnosis across a range of areas in experimental psychopathology. In particular, we summarise the historical and more recent uses of hypnosis to create and explore clinically relevant, temporary delusions. We then describe in detail the steps that hypnosis researchers take in constructing a hypnotic paradigm to map the features and processes shared by clinical and hypnotic delusions, as well as their impact on information processing (including autobiographical memory). We illustrate with hypnotic versions of mirrored-self misidentification, somatoparaphrenia, alien control, and identity delusions. Finding indicate that hypnotic analogues can produce compelling delusions with features that are strikingly similar to their clinical counterparts. These similarities encompass phenomenological features of delusions, delusional resistance to challenge, and autobiographical memory during delusions. We recognise important methodological issues and limitations of such hypnotic analogues, including: indexing response (behaviour vs. experience), alternative explanations (e.g., social compliance), the need for converging data, the need for close and continuing dialogue between the clinic and the laboratory, and generalisability of the findings.

  4. Global Health and Emergency Care: Overcoming Clinical Research Barriers.

    Science.gov (United States)

    Levine, Adam C; Barry, Meagan A; Agrawal, Pooja; Duber, Herbert C; Chang, Mary P; Mackey, Joy M; Hansoti, Bhakti

    2017-04-01

    There are many barriers impeding the conduct of high-quality emergency care research, particularly in low- and middle-income countries. Several of these barriers were originally outlined in 2013 as part of the Academic Emergency Medicine Global Health and Emergency Care Consensus Conference. This paper seeks to establish a broader consensus on the barriers to emergency care research globally and proposes a comprehensive array of new recommendations to overcome these barriers. An electronic survey was conducted of a purposive sample of global emergency medicine research experts from around the world to describe the major challenges and solutions to conducting emergency care research in low-resource settings and rank them by importance. The Global Emergency Medicine Think Tank Clinical Research Working Group at the Society for Academic Emergency Medicine 2016 Annual Meeting utilized a modified Delphi technique for consensus-based decision making to categorize and expand upon these barriers and develop a comprehensive array of proposed solutions. The working group identified four broad categories of barriers to conducting emergency care research globally, including 1) the limited availability of research personnel, particularly those with prior research training; 2) logistic barriers and lack of standardization of data collection; 3) ethical barriers to conducting research in resource-limited settings, particularly when no local institutional review board is available; and 4) the relative dearth of funding for global emergency care research. Proposed solutions included building a diverse and interdisciplinary research team structured to promote mentorship of junior researchers, utilizing local research assistants or technologic tools such as telemedicine for language translation, making use of new tools such as mobile health (mHealth) to standardize and streamline data collection, identifying alternatives to local institutional review board approval and the use of

  5. Citation analysis may severely underestimate the impact of clinical research as compared to basic research.

    Science.gov (United States)

    van Eck, Nees Jan; Waltman, Ludo; van Raan, Anthony F J; Klautz, Robert J M; Peul, Wilco C

    2013-01-01

    Citation analysis has become an important tool for research performance assessment in the medical sciences. However, different areas of medical research may have considerably different citation practices, even within the same medical field. Because of this, it is unclear to what extent citation-based bibliometric indicators allow for valid comparisons between research units active in different areas of medical research. A visualization methodology is introduced that reveals differences in citation practices between medical research areas. The methodology extracts terms from the titles and abstracts of a large collection of publications and uses these terms to visualize the structure of a medical field and to indicate how research areas within this field differ from each other in their average citation impact. Visualizations are provided for 32 medical fields, defined based on journal subject categories in the Web of Science database. The analysis focuses on three fields: Cardiac & cardiovascular systems, Clinical neurology, and Surgery. In each of these fields, there turn out to be large differences in citation practices between research areas. Low-impact research areas tend to focus on clinical intervention research, while high-impact research areas are often more oriented on basic and diagnostic research. Popular bibliometric indicators, such as the h-index and the impact factor, do not correct for differences in citation practices between medical fields. These indicators therefore cannot be used to make accurate between-field comparisons. More sophisticated bibliometric indicators do correct for field differences but still fail to take into account within-field heterogeneity in citation practices. As a consequence, the citation impact of clinical intervention research may be substantially underestimated in comparison with basic and diagnostic research.

  6. The Design and Development of a Technology Based Orientation Manual for Clinical Research Coordinators

    Science.gov (United States)

    Copp, Susan L.

    2010-01-01

    The objective of this research was to use technology to develop an on-line orientation manual for clinical research coordinators. Many clinical research coordinators begin their careers as staff nurses and have little knowledge related to clinical research. As such, when they transition to a career in clinical research they lack the knowledge…

  7. Data Resource Profile: Clinical Practice Research Datalink (CPRD)

    Science.gov (United States)

    Herrett, Emily; Gallagher, Arlene M; Bhaskaran, Krishnan; Forbes, Harriet; Mathur, Rohini; van Staa, Tjeerd; Smeeth, Liam

    2015-01-01

    The Clinical Practice Research Datalink (CPRD) is an ongoing primary care database of anonymised medical records from general practitioners, with coverage of over 11.3 million patients from 674 practices in the UK. With 4.4 million active (alive, currently registered) patients meeting quality criteria, approximately 6.9% of the UK population are included and patients are broadly representative of the UK general population in terms of age, sex and ethnicity. General practitioners are the gatekeepers of primary care and specialist referrals in the UK. The CPRD primary care database is therefore a rich source of health data for research, including data on demographics, symptoms, tests, diagnoses, therapies, health-related behaviours and referrals to secondary care. For over half of patients, linkage with datasets from secondary care, disease-specific cohorts and mortality records enhance the range of data available for research. The CPRD is very widely used internationally for epidemiological research and has been used to produce over 1000 research studies, published in peer-reviewed journals across a broad range of health outcomes. However, researchers must be aware of the complexity of routinely collected electronic health records, including ways to manage variable completeness, misclassification and development of disease definitions for research. PMID:26050254

  8. Is audit research? The relationships between clinical audit and social-research.

    Science.gov (United States)

    Hughes, Rhidian

    2005-01-01

    Quality has an established history in health care. Audit, as a means of quality assessment, is well understood and the existing literature has identified links between audit and research processes. This paper reviews the relationships between audit and research processes, highlighting how audit can be improved through the principles and practice of social research. The review begins by defining the audit process. It goes on to explore salient relationships between clinical audit and research, grouped into the following broad themes: ethical considerations, highlighting responsibilities towards others and the need for ethical review for audit; asking questions and using appropriate methods, emphasising transparency in audit methods; conceptual issues, including identifying problematic concepts, such as "satisfaction", and the importance of reflexivity within audit; emphasising research in context, highlighting the benefits of vignettes and action research; complementary methods, demonstrating improvements for the quality of findings; and training and multidisciplinary working, suggesting the need for closer relationships between researchers and clinical practitioners. Audit processes cannot be considered research. Both audit and research processes serve distinct purposes. Attention to the principles of research when conducting audit are necessary to improve the quality of audit and, in turn, the quality of health care.

  9. Brazilian Clinical Trials Registry and the challenges for clinical research governance.

    Science.gov (United States)

    Laguardia, Josué; Piolli, Alessandro Luís; Prevot, Margareth; Ramalho, Luciano; Gamarski, Ricardo; Nishizawa, Claudio

    2011-01-01

    Over the past five years, efforts to set up a Brazilian clinical trials registry have progressed from early discussions in academic forums through to the establishment of the registry as a web-based computer platform. This article describes the process of developing and introducing the Brazilian Clinical Trials Registry (ReBEC), and its relationship with the authorities that regulate clinical research in Brazil. The Brazilian Clinical Trials Registry and the multilingual, free and open source, internet-based software developed to manage it are outcomes of partnerships among Brazilian federal and international health agencies. Information for describing the technical and operational dimensions of Rebec was drawn from technical documents and the records of the OpenTrials software development team and the ReBEC executive and advisory committees, which are available in free-access repositories. The Brazilian Clinical Trials Registry was launched in December 2010, and approved as a primary registry of the WHO ICTRP network in April 2011. ReBEC's arrival on-line and its acceptance as an ICTRP primary registry is a significant step in consolidating a policy of free access to information on clinical research in Brazil. © 2011 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

  10. Smart Extraction and Analysis System for Clinical Research.

    Science.gov (United States)

    Afzal, Muhammad; Hussain, Maqbool; Khan, Wajahat Ali; Ali, Taqdir; Jamshed, Arif; Lee, Sungyoung

    2017-05-01

    With the increasing use of electronic health records (EHRs), there is a growing need to expand the utilization of EHR data to support clinical research. The key challenge in achieving this goal is the unavailability of smart systems and methods to overcome the issue of data preparation, structuring, and sharing for smooth clinical research. We developed a robust analysis system called the smart extraction and analysis system (SEAS) that consists of two subsystems: (1) the information extraction system (IES), for extracting information from clinical documents, and (2) the survival analysis system (SAS), for a descriptive and predictive analysis to compile the survival statistics and predict the future chance of survivability. The IES subsystem is based on a novel permutation-based pattern recognition method that extracts information from unstructured clinical documents. Similarly, the SAS subsystem is based on a classification and regression tree (CART)-based prediction model for survival analysis. SEAS is evaluated and validated on a real-world case study of head and neck cancer. The overall information extraction accuracy of the system for semistructured text is recorded at 99%, while that for unstructured text is 97%. Furthermore, the automated, unstructured information extraction has reduced the average time spent on manual data entry by 75%, without compromising the accuracy of the system. Moreover, around 88% of patients are found in a terminal or dead state for the highest clinical stage of disease (level IV). Similarly, there is an ∼36% probability of a patient being alive if at least one of the lifestyle risk factors was positive. We presented our work on the development of SEAS to replace costly and time-consuming manual methods with smart automatic extraction of information and survival prediction methods. SEAS has reduced the time and energy of human resources spent unnecessarily on manual tasks.

  11. [Mental issues of clinical research interviews in an intercultural context].

    Science.gov (United States)

    Kim, M-S; Derivois, D

    2013-10-01

    The interview is an intersubjective meeting in which the stakes are complex. This frequently used method in social and human sciences research brings to the foreground various mental processes. Despite its clear distinction from the therapeutic interview, due to its purpose and the origin of the request, the research interview generates for both the participant and the researcher unconscious phenomena and contributes to the epistemological reflection inherent to the clinical approach. The aim of this article is to demonstrate that the mental processes mobilized in the participants and in the researcher, who belong to the same culture of origin during the research interview, may be analyzed in four dimensions: intrapsychique, intersubjective, projective and group. So as to illustrate the various mental processes that are engaged, a research conducted in clinical intercultural psychology regarding the adaptive processes and the identity strategies of Korean mothers living in France or in Quebec is used. In order to offer maximum freedom of expression to the participants, the interviews were conducted in Korean, and then translated into French. The intrapsychic dimension is illustrated by an example from the interview with a 44-year-old Korean woman met in Paris. Following the Rogerian theory (1952, 1961), we understand that the participant comes to a coherent reorganization of her own conception throughout the interview, allowing her to speak and to think about her autobiography. From the interaction between two subjectivities, the thought and the discourse are involved in the co-construction of meaning. The understanding of the intersubjective dimension is supported by the theory of Winnicott (1971), developed for the transitional space. Like the mother-child relationship in the game device, the mental permeability available to the researcher is supposed to guarantee the development of the interviewee's confidence. The example of the interview conducted with another

  12. Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research.

    Science.gov (United States)

    Tan, Meng H; Bernstein, Steven J; Gendler, Stephen; Hanauer, David; Herman, William H

    2016-03-01

    A major challenge in conducting clinical trials/studies is the timely recruitment of eligible subjects. Our aim is to develop a Diabetes Research Registry (DRR) to facilitate recruitment by matching potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their electronic health records (EHR). A committee with expertise in diabetes, quality improvement, information technology, and informatics designed and developed the DRR. Using a hybrid approach, we identified and consented patients interested in research, abstracted their EHRs to assess common eligibility criteria, and contacted them about their interest in participating in specific studies. Investigators submit their requests with study entry criteria to the DRR which then provides a list of potential subjects who may be directly contacted for their study. The DRR meets all local, regional and federal regulatory requirements. After 5 years, the DRR has over 5000 registrants. About 30% have type 1 diabetes and 70% have type 2 diabetes. There are almost equal proportions of men and women. During this period, 31 unique clinical studies from 19 unique investigators requested lists of potential subjects for their studies. Eleven grant applications from 10 unique investigators used aggregated counts of potentially eligible subjects in their applications. The DRR matches potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their EHR. By providing large lists of potentially eligible study subjects quickly, the DRR facilitated recruitment in 31 clinical studies. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research.

    Science.gov (United States)

    Ortiz-Osorno, Alberto Betto; Ehler, Linda A; Brooks, Judith

    2015-01-01

    Determining what constitutes an anticipatable incidental finding (IF) from clinical research and defining whether, and when, this IF should be returned to the participant have been topics of discussion in the field of human subject protections for the last 10 years. It has been debated that implementing a comprehensive IF-approach that addresses both the responsibility of researchers to return IFs and the expectation of participants to receive them can be logistically challenging. IFs have been debated at different levels, such as the ethical reasoning for considering their disclosure or the need for planning for them during the development of the research study. Some authors have discussed the methods for re-contacting participants for disclosing IFs, as well as the relevance of considering the clinical importance of the IFs. Similarly, other authors have debated about when IFs should be disclosed to participants. However, no author has addressed how the "actionability" of the IFs should be considered, evaluated, or characterized at the participant's research setting level. This paper defines the concept of "Actionability at the Participant's Research Setting Level" (APRSL) for anticipatable IFs from clinical research, discusses some related ethical concepts to justify the APRSL concept, proposes a strategy to incorporate APRSL into the planning and management of IFs, and suggests a strategy for integrating APRSL at each local research setting. © 2015 American Society of Law, Medicine & Ethics, Inc.

  14. Emerging uses of patient generated health data in clinical research.

    Science.gov (United States)

    Wood, William A; Bennett, Antonia V; Basch, Ethan

    2015-05-01

    Recent advancements in consumer directed personal computing technology have led to the generation of biomedically-relevant data streams with potential health applications. This has catalyzed international interest in Patient Generated Health Data (PGHD), defined as "health-related data - including health history, symptoms, biometric data, treatment history, lifestyle choices, and other information-created, recorded, gathered, or inferred by or from patients or their designees (i.e. care partners or those who assist them) to help address a health concern."(Shapiro et al., 2012) PGHD offers several opportunities to improve the efficiency and output of clinical trials, particularly within oncology. These range from using PGHD to understand mechanisms of action of therapeutic strategies, to understanding and predicting treatment-related toxicity, to designing interventions to improve adherence and clinical outcomes. To facilitate the optimal use of PGHD, methodological research around considerations related to feasibility, validation, measure selection, and modeling of PGHD streams is needed. With successful integration, PGHD can catalyze the application of "big data" to cancer clinical research, creating both "n of 1" and population-level observations, and generating new insights into the nature of health and disease. Copyright © 2014 Federation of European Biochemical Societies. Published by Elsevier B.V. All rights reserved.

  15. Ethical considerations in clinical training, care and research in psychopharmacology.

    Science.gov (United States)

    Strous, Rael D

    2011-04-01

    Psychopharmacology is a powerful tool in psychiatry; however, it is one that demands responsibility in order to deal with the ethical complexities that accompany advances in the field. It is important that questions are asked and that ethical mindfulness and sensitivity are developed along with clinical skills. In order to cultivate and deepen ethical awareness and subsequently solve issues in optimal fashion, investment should be made in the development of an ethical decision-making process as well as in education in the ethics of psychopharmacology to trainees in the field at all stages of their educational development. A clear approach to identifying ethical problems, engaging various ethical concepts in considering solutions and then applying these principles in problem resolution is demanded. An openness in identifying and exploring issues has become crucial to the future development and maturation of psychopharmacologists, both research and clinical. Consideration must be given to the social implications of psychopharmacological practice, with the best interests of patients always paramount. From both a research and clinical perspective, psychopharmacology has to be practised with fairness, sensitivity and ethical relevance to all. While ethical issues related to psychopharmacological practice are varied and plentiful, this review focuses on advances in technology and biological sciences, personal integrity, special populations, and education and training.

  16. Discovering Hands - México

    OpenAIRE

    Salamanca Cárdenas, Daniela; Castelblanco Domínguez, Junio Andrés; Aguilar Ardila, Laura Andrea

    2016-01-01

    El modelo de Discovering Hands ha sido reconocido internacionalmente como un proyecto innovador que se ha expandido por diferentes países del mundo, como Austria, y se ha empezado a estudiar la propuesta en países como República Checa, India y Colombia. (Discovering Hands, 2016). Esto se debe a que no solo mejora el tratamiento de cáncer de mama, sino que también reduce los costos totales de tratamiento de la enfermedad y aumenta la fuerza laborar de los países donde esté presente. Al represe...

  17. Research Challenges and Opportunities for Clinically Oriented Academic Radiology Departments.

    Science.gov (United States)

    Decker, Summer J; Grajo, Joseph R; Hazelton, Todd R; Hoang, Kimberly N; McDonald, Jennifer S; Otero, Hansel J; Patel, Midhir J; Prober, Allen S; Retrouvey, Michele; Rosenkrantz, Andrew B; Roth, Christopher G; Ward, Robert J

    2016-01-01

    Between 2004 and 2012, US funding for the biomedical sciences decreased to historic lows. Health-related research was crippled by receiving only 1/20th of overall federal scientific funding. Despite the current funding climate, there is increased pressure on academic radiology programs to establish productive research programs. Whereas larger programs have resources that can be utilized at their institutions, small to medium-sized programs often struggle with lack of infrastructure and support. To address these concerns, the Association of University Radiologists' Radiology Research Alliance developed a task force to explore any untapped research productivity potential in these smaller radiology departments. We conducted an online survey of faculty at smaller clinically funded programs and found that while they were interested in doing research and felt it was important to the success of the field, barriers such as lack of resources and time were proving difficult to overcome. One potential solution proposed by this task force is a collaborative structured research model in which multiple participants from multiple institutions come together in well-defined roles that allow for an equitable distribution of research tasks and pooling of resources and expertise. Under this model, smaller programs will have an opportunity to share their unique perspective on how to address research topics and make a measureable impact on the field of radiology as a whole. Through a health services focus, projects are more likely to succeed in the context of limited funding and infrastructure while simultaneously providing value to the field. Copyright © 2016 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

  18. Assessing research impact in academic clinical medicine: a study using Research Excellence Framework pilot impact indicators

    Directory of Open Access Journals (Sweden)

    Ovseiko Pavel V

    2012-12-01

    Full Text Available Abstract Background Funders of medical research the world over are increasingly seeking, in research assessment, to complement traditional output measures of scientific publications with more outcome-based indicators of societal and economic impact. In the United Kingdom, the Higher Education Funding Council for England (HEFCE developed proposals for the Research Excellence Framework (REF to allocate public research funding to higher education institutions, inter alia, on the basis of the social and economic impact of their research. In 2010, it conducted a pilot exercise to test these proposals and refine impact indicators and criteria. Methods The impact indicators proposed in the 2010 REF impact pilot exercise are critically reviewed and appraised using insights from the relevant literature and empirical data collected for the University of Oxford’s REF pilot submission in clinical medicine. The empirical data were gathered from existing administrative sources and an online administrative survey carried out by the university’s Medical Sciences Division among 289 clinical medicine faculty members (48.1% response rate. Results The feasibility and scope of measuring research impact in clinical medicine in a given university are assessed. Twenty impact indicators from seven categories proposed by HEFCE are presented; their strengths and limitations are discussed using insights from the relevant biomedical and research policy literature. Conclusions While the 2010 pilot exercise has confirmed that the majority of the proposed indicators have some validity, there are significant challenges in operationalising and measuring these indicators reliably, as well as in comparing evidence of research impact across different cases in a standardised manner. It is suggested that the public funding agencies, medical research charities, universities, and the wider medical research community work together to develop more robust methodologies for capturing

  19. Assessing research impact in academic clinical medicine: a study using Research Excellence Framework pilot impact indicators.

    Science.gov (United States)

    Ovseiko, Pavel V; Oancea, Alis; Buchan, Alastair M

    2012-12-23

    Funders of medical research the world over are increasingly seeking, in research assessment, to complement traditional output measures of scientific publications with more outcome-based indicators of societal and economic impact. In the United Kingdom, the Higher Education Funding Council for England (HEFCE) developed proposals for the Research Excellence Framework (REF) to allocate public research funding to higher education institutions, inter alia, on the basis of the social and economic impact of their research. In 2010, it conducted a pilot exercise to test these proposals and refine impact indicators and criteria. The impact indicators proposed in the 2010 REF impact pilot exercise are critically reviewed and appraised using insights from the relevant literature and empirical data collected for the University of Oxford's REF pilot submission in clinical medicine. The empirical data were gathered from existing administrative sources and an online administrative survey carried out by the university's Medical Sciences Division among 289 clinical medicine faculty members (48.1% response rate). The feasibility and scope of measuring research impact in clinical medicine in a given university are assessed. Twenty impact indicators from seven categories proposed by HEFCE are presented; their strengths and limitations are discussed using insights from the relevant biomedical and research policy literature. While the 2010 pilot exercise has confirmed that the majority of the proposed indicators have some validity, there are significant challenges in operationalising and measuring these indicators reliably, as well as in comparing evidence of research impact across different cases in a standardised manner. It is suggested that the public funding agencies, medical research charities, universities, and the wider medical research community work together to develop more robust methodologies for capturing and describing impact, including more valid and reliable impact

  20. Clinical nurse research consultant: a clinical and academic role to advance practice and the discipline of nursing.

    Science.gov (United States)

    Currey, Judy; Considine, Julie; Khaw, Damien

    2011-10-01

    This article presents a proposal for the Clinical Nurse Research Consultant, a new nursing role. Although healthcare delivery continues to evolve, nursing has lacked highly specialized clinical and research leadership that, as a primary responsibility, drives evidence-based practice change in collaboration with bedside clinicians. International literature published over the last 25 years in the databases of CINAHL, OVID, Medline Pubmed, Science Direct, Expanded Academic, ESBSCOhost, Scopus and Proquest is cited to create a case for the Clinical Nurse Research Consultant. The Clinical Nurse Research Consultant will address the research/practice gap and assist in facilitating evidence-based clinical practice. To fulfil the responsibilities of this proposed role, the Clinical Nurse Research Consultant must be a doctorally prepared recognized clinical expert, have educational expertise, and possess advanced interpersonal, teamwork and communication skills. This role will enable clinical nurses to maintain and share their clinical expertise, advance practice through research and role model the clinical/research nexus. Critically, the Clinical Nurse Research Consultant must be appointed in a clinical and academic partnership to provide for career progression and role support. The creation of the Clinical Nurse Research Consultant will advance nursing practice and the discipline of nursing. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.

  1. Booklet of the Research Institute of Clinical Medicine

    International Nuclear Information System (INIS)

    Todua, F.; Jgamadze, N.; Todua, N.; Beriashvili, Z.; Chelishvili, M.; Todua, I.; Chovelidze, Sh. et al.

    2012-01-01

    Research Institute of Clinical Medicine is one of the biggest university diagnostic and treatment centre in Georgia with unique modern diagnostic and treatment apparatus. The institute is acknowledged as a leader in various trends of radiology and surgery. The Research Institute of Clinical Medicine was founded in 1991. It is the leading scientific establishment in the field of medicine. The scientific-research work of the Institute is coordinated by the National Academy of Sciences of Georgia. The main scientific trend of the Institute is the Early Complex Diagnostics and Treatment. The scientific activity of the Institute is led by the Scientific Council. Institute achieved remarkable success since its foundation: It has been defended 56 theses for Candidate of Medical Sciences and 16 for Doctor of Medical Sciences; About 30 post-graduate students and more than 200 radiologists have taken training courses in radiology. Nowadays they work in different regions of Georgia, 21 inventions took out patents. It has been published 2000 scientific works and 9 monographs. (authors)

  2. Integrative Mental Health (IMH): paradigm, research, and clinical practice.

    Science.gov (United States)

    Lake, James; Helgason, Chanel; Sarris, Jerome

    2012-01-01

    This paper provides an overview of the rapidly evolving paradigm of "Integrative Mental Health (IMH)." The paradigm of contemporary biomedical psychiatry and its contrast to non-allopathic systems of medicine is initially reviewed, followed by an exploration of the emerging paradigm of IMH, which aims to reconcile the bio-psycho-socio-spiritual model with evidence-based methods from traditional healing practices. IMH is rapidly transforming conventional understandings of mental illness and has significant positive implications for the day-to-day practice of mental health care. IMH incorporates mainstream interventions such as pharmacologic treatments, psychotherapy, and psychosocial interventions, as well as alternative therapies such as acupuncture, herbal and nutritional medicine, dietary modification, meditation, etc. Two recent international conferences in Europe and the United States show that interest in integrative mental health care is growing rapidly. In response, the International Network of Integrative Mental Health (INIMH: www.INIMH.org) was established in 2010 with the objective of creating an international network of clinicians, researchers, and public health advocates to advance a global agenda for research, education, and clinical practice of evidence-based integrative mental health care. The paper concludes with a discussion of emerging opportunities for research in IMH, and an exploration of potential clinical applications of integrative mental health care. Copyright © 2012 Elsevier Inc. All rights reserved.

  3. A practical approach to clinical and research biobanking.

    Science.gov (United States)

    Yong, William H; Dry, Sarah M; Shabihkhani, Maryam

    2014-01-01

    Powerful technologies critical to personalized medicine and targeted therapeutics require the analysis of carefully validated, procured, stored, and managed biospecimens. Reflecting advancements in biospecimen science, the National Cancer Institute and the International Society for Biological and Environmental Repositories are periodically publishing best practices that can guide the biobanker. The modern biobank will operate more like a clinical laboratory with formal accreditation, standard operating procedures, and quality assurance protocols. This chapter highlights practical issues of consent, procurement, storage, quality assurance, disbursement, funding, and space. Common topics of concern are discussed including the differences between clinical and research biospecimens, stabilization of biospecimens during procurement, optimal storage temperatures, and technical validation of biospecimen content and quality. With quickly expanding biospecimen needs and limited healthcare budgets, biobanks may need to be selective as to what is stored. Furthermore, a shift to room-temperature storage modalities where possible can reduce long-term space and fiscal requirements.

  4. Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

    Science.gov (United States)

    Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

    2016-01-01

    Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

  5. Clinical trial network for the promotion of clinical research for rare diseases in Japan: muscular dystrophy clinical trial network.

    Science.gov (United States)

    Shimizu, Reiko; Ogata, Katsuhisa; Tamaura, Akemi; Kimura, En; Ohata, Maki; Takeshita, Eri; Nakamura, Harumasa; Takeda, Shin'ichi; Komaki, Hirofumi

    2016-07-11

    Duchenne muscular dystrophy (DMD) is the most commonly inherited neuromuscular disease. Therapeutic agents for the treatment of rare disease, namely "orphan drugs", have recently drawn the attention of researchers and pharmaceutical companies. To ensure the successful conduction of clinical trials to evaluate novel treatments for patients with rare diseases, an appropriate infrastructure is needed. One of the effective solutions for the lack of infrastructure is to establish a network of rare diseases. To accomplish the conduction of clinical trials in Japan, the Muscular dystrophy clinical trial network (MDCTN) was established by the clinical research group for muscular dystrophy, including the National Center of Neurology and Psychiatry, as well as national and university hospitals, all which have a long-standing history of research cooperation. Thirty-one medical institutions (17 national hospital organizations, 10 university hospitals, 1 national center, 2 public hospitals, and 1 private hospital) belong to this network and collaborate to facilitate clinical trials. The Care and Treatment Site Registry (CTSR) calculates and reports the proportion of patients with neuromuscular diseases in the cooperating sites. In total, there are 5,589 patients with neuromuscular diseases in Japan and the proportion of patients with each disease is as follows: DMD, 29 %; myotonic dystrophy type 1, 23 %; limb girdle muscular dystrophy, 11 %; Becker muscular dystrophy, 10 %. We work jointly to share updated health care information and standardized evaluations of clinical outcomes as well. The collaboration with the patient registry (CTSR), allows the MDCTN to recruit DMD participants with specific mutations and conditions, in a remarkably short period of time. Counting with a network that operates at a national level is important to address the corresponding national issues. Thus, our network will be able to contribute with international research activity, which can lead to

  6. Animal models of osteogenesis imperfecta: applications in clinical research

    Directory of Open Access Journals (Sweden)

    Enderli TA

    2016-09-01

    Full Text Available Tanya A Enderli, Stephanie R Burtch, Jara N Templet, Alessandra Carriero Department of Biomedical Engineering, Florida Institute of Technology, Melbourne, FL, USA Abstract: Osteogenesis imperfecta (OI, commonly known as brittle bone disease, is a genetic disease characterized by extreme bone fragility and consequent skeletal deformities. This connective tissue disorder is caused by mutations in the quality and quantity of the collagen that in turn affect the overall mechanical integrity of the bone, increasing its vulnerability to fracture. Animal models of the disease have played a critical role in the understanding of the pathology and causes of OI and in the investigation of a broad range of clinical therapies for the disease. Currently, at least 20 animal models have been officially recognized to represent the phenotype and biochemistry of the 17 different types of OI in humans. These include mice, dogs, and fish. Here, we describe each of the animal models and the type of OI they represent, and present their application in clinical research for treatments of OI, such as drug therapies (ie, bisphosphonates and sclerostin and mechanical (ie, vibrational loading. In the future, different dosages and lengths of treatment need to be further investigated on different animal models of OI using potentially promising treatments, such as cellular and chaperone therapies. A combination of therapies may also offer a viable treatment regime to improve bone quality and reduce fragility in animals before being introduced into clinical trials for OI patients. Keywords: OI, brittle bone, clinical research, mouse, dog, zebrafish

  7. How to Develop an Electronic Clinical Endometriosis Research File Integrated in Clinical Practice.

    Science.gov (United States)

    Vanhie, A; Fassbender, A; O, D; Tomassetti, C; Meuleman, C; Peeraer, K; Debrock, S; D'Hooghe, Th

    2015-01-01

    Endometriosis is associated with a range of pelvic-abdominal pain symptoms and infertility. It is a chronic disease that can have a significant impact on various aspects of women's lives, including their social and sexual relationships, work, and study. Despite several international guidelines on the management of endometriosis, there is a wide variety of clinical practice in the management of endometriosis, resulting in many women receiving delayed or suboptimal care. In this paper we discuss the possibilities and benefits of using electronic health records for clinical research in the field of endometriosis. The development of a wide range of clinical software for electronic patient records has made the registration of large datasets feasible and the integration of research files and clinical files possible. Integration of global standards on registration of endometriosis care in electronic health records could improve reporting of research data and facilitate the execution of large, multicentre randomized trials on the management of endometriosis. These highly needed trials could bring us the evidence needed for the optimisation of management of women with endometriosis.

  8. How to Develop an Electronic Clinical Endometriosis Research File Integrated in Clinical Practice

    Directory of Open Access Journals (Sweden)

    A. Vanhie

    2015-01-01

    Full Text Available Endometriosis is associated with a range of pelvic-abdominal pain symptoms and infertility. It is a chronic disease that can have a significant impact on various aspects of women’s lives, including their social and sexual relationships, work, and study. Despite several international guidelines on the management of endometriosis, there is a wide variety of clinical practice in the management of endometriosis, resulting in many women receiving delayed or suboptimal care. In this paper we discuss the possibilities and benefits of using electronic health records for clinical research in the field of endometriosis. The development of a wide range of clinical software for electronic patient records has made the registration of large datasets feasible and the integration of research files and clinical files possible. Integration of global standards on registration of endometriosis care in electronic health records could improve reporting of research data and facilitate the execution of large, multicentre randomized trials on the management of endometriosis. These highly needed trials could bring us the evidence needed for the optimisation of management of women with endometriosis.

  9. Financial conflict-of-interest policies in clinical research: issues for clinical investigators.

    Science.gov (United States)

    Boyd, Elizabeth A; Cho, Mildred K; Bero, Lisa A

    2003-08-01

    As industry sponsorship of clinical research grows, investigators' personal financial relationships with those sponsors are under increasing scrutiny. The federal government, some states, and many universities have enacted conflict-of-interest policies to monitor and regulate investigators' financial relationships. Little is known, however, about investigators' awareness of or support for these policies or their attitudes toward regulatory efforts. To explore the possible implications of conflict-of-interest policies for clinical researchers, the authors interviewed active clinical investigators at two institutions where the conflict-of-interest policies differ. The most striking feature of the interviews was the range of perceptions and attitudes expressed by clinical investigators and their implications for administrators, professional societies, and policymakers concerned with conflicts of interest. Fewer than half of the interviewed investigators could accurately describe their campus' conflict-of-interest policy. Many investigators felt that professional societies, the public, and individual investigators were appropriate monitors of conflicts of interest. Many investigators recognized the general risks associated with conflicts of interest, but felt that they personally were not at risk. A fundamental challenge facing administrators and policymakers is to demonstrate to all investigators, both clinical and nonclinical, that the potential for bias, pressure and conflict is relevant to all investigators with industry relationships.

  10. Henry Beecher's Contributions to the Ethics of Clinical Research.

    Science.gov (United States)

    Veatch, Robert M

    2016-01-01

    In the 1950s and '60s, Henry Beecher pioneered the discussion of the ethics of clinical research, leading eventually to the publication of the famous New England Journal of Medicine article summarizing 22 research studies that Beecher suggests were unethical. Those studies generally showed a pattern of posing serious risks to subjects without anticipated proportional benefit. Beecher famously claimed that the problem was not that researchers were malicious or evil; rather, he claimed the problem was they manifested thoughtlessness or carelessness. He called for more rigorous self-scrutiny rather than public review.This article argues that Beecher's reliance on conscientious investigators is problematic. In particular, it focuses on benefits and harms to the exclusion of other moral criteria. However, both research subjects and public regulators are also concerned about autonomy and the consent requirement, confidentiality, and fairness in subject selection and research design. The movement in the 1970s toward more public scrutiny was critical, even though Beecher was right in holding that it was not "vicious disregard for subject welfare" that explained unethical protocols.

  11. 77 FR 26069 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2012-05-02

    ... Department of Veterans Affairs (VA) gives notice under the Public Law 92-463 (Federal Advisory Committee Act...'Enfant Plaza Hotel, and not on June 11-12, 2012. Clinical Research Program will meet on June 7-8, 2012, at *VA Central Office and not at Sheraton Suites--Old Town Alexandria. The addresses of the hotel and...

  12. Common data elements for spinal cord injury clinical research

    DEFF Research Database (Denmark)

    Biering-Sørensen, F; Alai, S; Anderson, K.

    2015-01-01

    OBJECTIVES: To develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in spinal cord injury (SCI) clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National...... with and cross-referenced to development of the International Spinal Cord Society (ISCoS) International SCI Data Sets. The recommendations were compiled, subjected to internal review and posted online for external public comment. The final version was reviewed by all working groups and the NINDS CDE team before...

  13. Deep sequencing in pre- and clinical vaccine research.

    Science.gov (United States)

    Prachi, P; Donati, C; Masciopinto, F; Rappuoli, R; Bagnoli, F

    2013-01-01

    Vaccine research has experienced a quantum leap after the beginning of the genomics era. High-throughput sequencing techniques, unlimited computing resources, as well as new bioinformatic algorithms are now changing the way we perform genomic studies. Whole genome sequencing will soon become the gold standard for phylogenetic and epidemiology studies and is already shedding new light on the dynamics of bacterial evolution. We believe that deep sequencing projects, together with structural studies on vaccine candidates, will allow targeting constant epitopes and avoid vaccine failure due to antigenic variability. Systems biology, which is expected to revolutionize vaccine research and clinical studies, greatly relies on high-throughput technologies such as RNA-seq. Furthermore, genomics is a key element to develop safer vaccines, and the accuracy of deep sequencing will allow monitoring vaccine coverage after their introduction on the market. Copyright © 2013 S. Karger AG, Basel.

  14. Research incentive program for clinical surgical faculty associated with increases in research productivity.

    Science.gov (United States)

    Schroen, Anneke T; Thielen, Monika J; Turrentine, Florence E; Kron, Irving L; Slingluff, Craig L

    2012-11-01

    To develop a research productivity scoring program within an academic department of surgery that would help realign incentives to encourage and reward research. Although research is highly valued in the academic mission, financial incentives are generally aligned to reward clinical productivity. A formula assigning points for publications and extramural grants was created and used to award a research incentive payment proportional to the research productivity score, beginning July 2007. Publication points reflect journal impact factor, author role, and manuscript type. Grant points reflect total funding and percentage of effort. Publication data were gathered from Web of Science/PubMed/Medline and grants data from the departmental grants office. An annual award is presented to the person with the greatest improvement. The research productivity score data after July 2007 were compared with control data for the 2 preceding years. A 33-question survey to 28 clinical faculty was conducted after the first year to measure satisfaction and solicit constructive feedback. The mean annual point scores increased from the preresearch productivity score to the postresearch productivity score academic years (2180 vs 3389, respectively, P = .08), with a significant change in the grant component score (272 vs 801, P = .03). Since research productivity score implementation, the operative case volumes increased 4.3% from 2006 to 2011. With a response rate of 89%, the survey indicated that 76% of the faculty wished to devote more time to research and 52% believed 1 or more research-related behaviors would change because of the research productivity score program. An objective, transparent research incentive program, through both monetary incentives and recognition, can stimulate productivity and was well-received by faculty. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  15. Can emergency medicine research benefit from adaptive design clinical trials?

    Science.gov (United States)

    Flight, Laura; Julious, Steven A; Goodacre, Steve

    2017-04-01

    Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  16. Recent theoretical, neural, and clinical advances in sustained attention research.

    Science.gov (United States)

    Fortenbaugh, Francesca C; DeGutis, Joseph; Esterman, Michael

    2017-05-01

    Models of attention often distinguish among attention subtypes, with classic models separating orienting, switching, and sustaining functions. Compared with other forms of attention, the neurophysiological basis of sustaining attention has received far less notice, yet it is known that momentary failures of sustained attention can have far-ranging negative effects in healthy individuals, and lasting sustained attention deficits are pervasive in clinical populations. In recent years, however, there has been increased interest in characterizing moment-to-moment fluctuations in sustained attention, in addition to the overall vigilance decrement, and understanding how these neurocognitive systems change over the life span and across various clinical populations. The use of novel neuroimaging paradigms and statistical approaches has allowed for better characterization of the neural networks supporting sustained attention and has highlighted dynamic interactions within and across multiple distributed networks that predict behavioral performance. These advances have also provided potential biomarkers to identify individuals with sustained attention deficits. These findings have led to new theoretical models explaining why sustaining focused attention is a challenge for individuals and form the basis for the next generation of sustained attention research, which seeks to accurately diagnose and develop theoretically driven treatments for sustained attention deficits that affect a variety of clinical populations. © 2017 New York Academy of Sciences.

  17. Examiner alignment and assessment in clinical periodontal research.

    Science.gov (United States)

    Hefti, Arthur F; Preshaw, Philip M

    2012-06-01

    Periodontal research typically relies on clinical examiners to assess variables such as gingival inflammation, plaque scores or probing depths as a means of determining treatment outcomes or for performing group comparisons. The quality of the gathered information is dependent, to a large extent, on the skills of the examiner(s) and on the validity of the assessment methods that are used. Attempts have been made to increase the objectivity of periodontal assessments, for example by introducing scoring systems for gingival inflammation, but within these systems there is often considerable scope for variation when interpreting the scoring criteria, leading to subjectivity when assigning scores to individual periodontal sites. This has led to an awareness of the importance of examiner alignment and assessment to improve the data quality by standardizing techniques and improving examiner reliability. Examiner alignment and assessment is used in preference to the term 'examiner calibration' because calibration implies comparison with an accurate or 'gold' standard, which is not available in periodontal research. In this review, we consider the historical perspective that led to the development of clinical scoring systems for periodontal research using gingival inflammation as an example. A clinical protocol for undertaking examiner alignment and assessment is presented, and we review the common sources of error and bias that can lead to difficulties in aligning examiners, and consider how they can be eliminated. It is particularly important that subjects who are recruited to the examiner alignment and assessment study present with a comparable level of disease to the subjects who will ultimately be recruited to the planned clinical trial. Another challenge in examiner alignment and assessment is applying appropriate statistical tests to assess the outcome of the alignment exercise. In the periodontal literature, the statistic kappa is frequently used to confirm an

  18. Missing data and multiple imputation in clinical epidemiological research.

    Science.gov (United States)

    Pedersen, Alma B; Mikkelsen, Ellen M; Cronin-Fenton, Deirdre; Kristensen, Nickolaj R; Pham, Tra My; Pedersen, Lars; Petersen, Irene

    2017-01-01

    Missing data are ubiquitous in clinical epidemiological research. Individuals with missing data may differ from those with no missing data in terms of the outcome of interest and prognosis in general. Missing data are often categorized into the following three types: missing completely at random (MCAR), missing at random (MAR), and missing not at random (MNAR). In clinical epidemiological research, missing data are seldom MCAR. Missing data can constitute considerable challenges in the analyses and interpretation of results and can potentially weaken the validity of results and conclusions. A number of methods have been developed for dealing with missing data. These include complete-case analyses, missing indicator method, single value imputation, and sensitivity analyses incorporating worst-case and best-case scenarios. If applied under the MCAR assumption, some of these methods can provide unbiased but often less precise estimates. Multiple imputation is an alternative method to deal with missing data, which accounts for the uncertainty associated with missing data. Multiple imputation is implemented in most statistical software under the MAR assumption and provides unbiased and valid estimates of associations based on information from the available data. The method affects not only the coefficient estimates for variables with missing data but also the estimates for other variables with no missing data.

  19. A Dimensional Bus model for integrating clinical and research data.

    Science.gov (United States)

    Wade, Ted D; Hum, Richard C; Murphy, James R

    2011-12-01

    Many clinical research data integration platforms rely on the Entity-Attribute-Value model because of its flexibility, even though it presents problems in query formulation and execution time. The authors sought more balance in these traits. Borrowing concepts from Entity-Attribute-Value and from enterprise data warehousing, the authors designed an alternative called the Dimensional Bus model and used it to integrate electronic medical record, sponsored study, and biorepository data. Each type of observational collection has its own table, and the structure of these tables varies to suit the source data. The observational tables are linked to the Bus, which holds provenance information and links to various classificatory dimensions that amplify the meaning of the data or facilitate its query and exposure management. The authors implemented a Bus-based clinical research data repository with a query system that flexibly manages data access and confidentiality, facilitates catalog search, and readily formulates and compiles complex queries. The design provides a workable way to manage and query mixed schemas in a data warehouse.

  20. Basics of case report form designing in clinical research.

    Science.gov (United States)

    Bellary, Shantala; Krishnankutty, Binny; Latha, M S

    2014-10-01

    Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

  1. [Transcranial direct current stimulation: new clinical roadmaps for psychiatric research].

    Science.gov (United States)

    Heeren, Alexandre; Coussement, Charlotte; Colon, Élisabeth

    Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that has undergone intensive research over the past decade with promising results. tDCS is based on the application of weak, direct current over the scalp, leading to cortical hypo- or hyperpolarization according to the specified parameters. Recent studies have shown that tDCS is able to induce potent changes in cortical excitability as well as to elicit long-lasting modifications in brain activity. Over the last decade, tDCS physiological mechanisms of action have been intensively investigated. This research has given support for the investigation of tDCS applications in a wide range of clinical populations, including patients with post-stroke motor and language deficits, chronic pain, and tinnitus. Recently, its efficacy to treat psychiatric conditions has been explored increasingly. In this review, we will gather clinical studies involving tDCS to ameliorate psychiatric symptoms and discuss reasonable next steps in this direction. © 2016 médecine/sciences – Inserm.

  2. Recruiting US Chinese Elders Into Clinical Research for Dementia.

    Science.gov (United States)

    Li, Clara; Neugroschl, Judith; Umpierre, Mari; Martin, Jane; Huang, QiYing; Zeng, Xiaoyi; Cai, Dongming; Sano, Mary

    2016-01-01

    This study described and evaluated the rapid recruitment of elderly Chinese into clinical research at the Mount Sinai Alzheimer's Disease Research Center (MSADRC). Methods of publicizing the study included lectures to local senior centers/churches and publications in local Chinese newspapers. The amount of time and success of these methods were evaluated. A "go to them" model of evaluation was used to enable participants to complete the study visit at locations where they were comfortable. From January to December 2015, we recruited 98 participants aged 65 years or older who primarily speak Mandarin/Cantonese and reside in New York. The mean age and years of education was 73.93±6.34 and 12.79±4.58, respectively. The majority of participants were female (65.3%) and primarily Mandarin speaking (53.1%). Of all enrollees, 54.1% were recruited from community lectures, 29.6% through newspapers, 10.2% through word of mouth, and 6.1% from our clinical services. About 40.8% of participants underwent evaluations at the MSADRC, 44.9% at local senior centers/churches, and 14.3% at home. Given that the majority of our participants had low English proficiency, the use of bilingual recruiters probably allowed us to overcome the language barrier, facilitating recruitment. Our "go to them" model of evaluation is another important factor contributing to our successful recruitment.

  3. Missing data and multiple imputation in clinical epidemiological research

    Directory of Open Access Journals (Sweden)

    Pedersen AB

    2017-03-01

    Full Text Available Alma B Pedersen,1 Ellen M Mikkelsen,1 Deirdre Cronin-Fenton,1 Nickolaj R Kristensen,1 Tra My Pham,2 Lars Pedersen,1 Irene Petersen1,2 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus N, Denmark; 2Department of Primary Care and Population Health, University College London, London, UK Abstract: Missing data are ubiquitous in clinical epidemiological research. Individuals with missing data may differ from those with no missing data in terms of the outcome of interest and prognosis in general. Missing data are often categorized into the following three types: missing completely at random (MCAR, missing at random (MAR, and missing not at random (MNAR. In clinical epidemiological research, missing data are seldom MCAR. Missing data can constitute considerable challenges in the analyses and interpretation of results and can potentially weaken the validity of results and conclusions. A number of methods have been developed for dealing with missing data. These include complete-case analyses, missing indicator method, single value imputation, and sensitivity analyses incorporating worst-case and best-case scenarios. If applied under the MCAR assumption, some of these methods can provide unbiased but often less precise estimates. Multiple imputation is an alternative method to deal with missing data, which accounts for the uncertainty associated with missing data. Multiple imputation is implemented in most statistical software under the MAR assumption and provides unbiased and valid estimates of associations based on information from the available data. The method affects not only the coefficient estimates for variables with missing data but also the estimates for other variables with no missing data. Keywords: missing data, observational study, multiple imputation, MAR, MCAR, MNAR

  4. Major clinical research advances in gynecologic cancer in 2013.

    Science.gov (United States)

    Suh, Dong Hoon; Kim, Jae-Weon; Kang, Sokbom; Kim, Hak Jae; Lee, Kyung-Hun

    2014-07-01

    In 2013, 10 topics were selected for major clinical research advances in gynecologic oncology; these included three topics regarding cervical cancer, three regarding ovarian cancer, two regarding endometrial cancer, and one each regarding breast cancer and radiation oncology. For cervical cancer, bevacizumab was first demonstrated to exhibit outstanding clinical efficacy in a recurrent, metastatic setting. Regarding cervical cancer screening, visual inspections with acetic acid in low-resource settings, p16/Ki-67 double staining, and the follow-up results of four randomized controlled trials of human papillomavirus-based screening methods were reviewed. Laparoscopic para-aortic lymphadenectomy before chemoradiation for locally advanced cervical cancer was the final topic for cervical cancer. Regarding front-line ovarian cancer therapies, dose-dense paclitaxel and carboplatin, intraperitoneal chemotherapy, and other targeted agents administered according to combination or maintenance schedules were discussed. Regarding recurrent ovarian cancer treatment, cediranib, olaparib, and farletuzumab were discussed for platinum-sensitive disease. The final overall survival data associated with a combination of bevacizumab and chemotherapy for platinum-resistant disease were briefly summarized. For endometrial cancer, the potential clinical efficacy of metformin, an antidiabetic drug, in obese patients was followed by integrated genomic analyses from the Cancer Genome Atlas Research Network. For breast cancer, three remarkable advances were reviewed: the long-term effects of continued adjuvant tamoxifen for 10 years, the effects of 2-year versus 1-year adjuvant trastuzumab for human epidermal growth factor receptor 2-positive disease, and the approval of pertuzumab in a neoadjuvant setting with a pathologic complete response as the surrogate endpoint. Finally, the recent large studies of intensity-modulated radiotherapy for gynecologic cancer were briefly summarized.

  5. A critique of statistical hypothesis testing in clinical research

    Directory of Open Access Journals (Sweden)

    Somik Raha

    2011-01-01

    Full Text Available Many have documented the difficulty of using the current paradigm of Randomized Controlled Trials (RCTs to test and validate the effectiveness of alternative medical systems such as Ayurveda. This paper critiques the applicability of RCTs for all clinical knowledge-seeking endeavors, of which Ayurveda research is a part. This is done by examining statistical hypothesis testing, the underlying foundation of RCTs, from a practical and philosophical perspective. In the philosophical critique, the two main worldviews of probability are that of the Bayesian and the frequentist. The frequentist worldview is a special case of the Bayesian worldview requiring the unrealistic assumptions of knowing nothing about the universe and believing that all observations are unrelated to each other. Many have claimed that the first belief is necessary for science, and this claim is debunked by comparing variations in learning with different prior beliefs. Moving beyond the Bayesian and frequentist worldviews, the notion of hypothesis testing itself is challenged on the grounds that a hypothesis is an unclear distinction, and assigning a probability on an unclear distinction is an exercise that does not lead to clarity of action. This critique is of the theory itself and not any particular application of statistical hypothesis testing. A decision-making frame is proposed as a way of both addressing this critique and transcending ideological debates on probability. An example of a Bayesian decision-making approach is shown as an alternative to statistical hypothesis testing, utilizing data from a past clinical trial that studied the effect of Aspirin on heart attacks in a sample population of doctors. As a big reason for the prevalence of RCTs in academia is legislation requiring it, the ethics of legislating the use of statistical methods for clinical research is also examined.

  6. Information Technology for Clinical, Translational and Comparative Effectiveness Research. Findings from the Yearbook 2015 Section on Clinical Research Informatics.

    Science.gov (United States)

    Daniel, C; Choquet, R

    2015-08-13

    To summarize excellent current research in the field of Bioinformatics and Translational Informatics with application in the health domain and clinical care. We provide a synopsis of the articles selected for the IMIA Yearbook 2015, from which we attempt to derive a synthetic overview of current and future activities in the field. As last year, a first step of selection was performed by querying MEDLINE with a list of MeSH descriptors completed by a list of terms adapted to the section. Each section editor has evaluated separately the set of 1,594 articles and the evaluation results were merged for retaining 15 articles for peer-review. The selection and evaluation process of this Yearbook's section on Bioinformatics and Translational Informatics yielded four excellent articles regarding data management and genome medicine that are mainly tool-based papers. In the first article, the authors present PPISURV a tool for uncovering the role of specific genes in cancer survival outcome. The second article describes the classifier PredictSNP which combines six performing tools for predicting disease-related mutations. In the third article, by presenting a high-coverage map of the human proteome using high resolution mass spectrometry, the authors highlight the need for using mass spectrometry to complement genome annotation. The fourth article is also related to patient survival and decision support. The authors present datamining methods of large-scale datasets of past transplants. The objective is to identify chances of survival. The current research activities still attest the continuous convergence of Bioinformatics and Medical Informatics, with a focus this year on dedicated tools and methods to advance clinical care. Indeed, there is a need for powerful tools for managing and interpreting complex, large-scale genomic and biological datasets, but also a need for user-friendly tools developed for the clinicians in their daily practice. All the recent research and

  7. Financial disclosure and clinical research: what is important to participants?

    Science.gov (United States)

    Hutchinson, Anastasia; Rubinfeld, Abe R

    2008-08-18

    To assess what participants in company-sponsored clinical trials wish to know about financial aspects of the study. Cross-sectional questionnaire administered to 324 participants in six clinical trials conducted at the Royal Melbourne Hospital in 1999-2000 and 2006 for non-acute conditions (asthma, chronic obstructive pulmonary disease, osteoporosis, rheumatoid arthritis, diabetes and influenza vaccine efficacy). Participants' desire for information on study funding, investigators' conflicts of interest, and use of accrued funds. 259 participants (80%) completed the survey. Participants wanted to be informed about the identity of the project sponsor (148 participants; 57%), whether the investigators owned shares in the company (105; 41%) or received travel grants (83; 32%), how much funding was accrued at study completion (88; 34%), how accrued funds were used (98; 38%), and who approved their use (91; 35%). After adjusting for year of survey and level of education, younger subjects (aged informed more often than older participants of who sponsored the project (odds ratio [OR], 2.35 [95% CI, 1.21-4.55]; P=0.012), whether the investigators owned shares in the company (OR, 2.41 [95% CI, 1.27-4.60]; P=0.007) and how much funding was available for other uses (OR, 1.79 [95% CI, 0.94-3.41]; P=0.078). While most participants indicated that they would take part in clinical research again regardless of whether they received financial information, providing information on the sponsor, the investigators' financial interest in the company, whether accrual of funds is expected, and how these funds will be spent should satisfy the interests of participants in company-sponsored clinical trials.

  8. Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.

    Science.gov (United States)

    Pencina, Michael J; Louzao, Darcy M; McCourt, Brian J; Adams, Monique R; Tayyabkhan, Rehbar H; Ronco, Peter; Peterson, Eric D

    2016-02-01

    There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Progress in clinical research in surgery and IDEAL.

    Science.gov (United States)

    McCulloch, Peter; Feinberg, Joshua; Philippou, Yiannis; Kolias, Angelos; Kehoe, Sean; Lancaster, Gillian; Donovan, Jenny; Petrinic, Tatjana; Agha, Riaz; Pennell, Christopher

    2018-01-17

    The quality of clinical research in surgery has long attracted criticism. High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have therefore been adopted without adequate supporting evidence of efficacy and safety. This evidence deficit can adversely affect research funding and reimbursement decisions, lead to slow adoption of innovations, and permit widespread adoption of procedures that offer no benefit, or cause harm. Improvement in the quality of surgical evidence would therefore be valuable. The Idea, Development, Exploration, Assessment, and Long-term Follow-up (IDEAL) Framework and Recommendations specify desirable qualities for surgical studies, and outline an integrated evaluation pathway for surgery, and similar complex interventions. We used the IDEAL Recommendations to assess methodological progress in surgical research over time, assessed the uptake and influence of IDEAL, and identified the challenges to further methodological progress. Comparing studies from the periods 2000-04 and 2010-14, we noted apparent improvement in the use of standard outcome measures, adoption of Consolidated Standards of Reporting Trials (CONSORT) standards, and assessment of the quality of surgery and of learning curves, but no progress in the use of qualitative research or reporting of modifications during procedure development. Better education about research, integration of rigorous evaluation into routine practice and training, and linkage of such work to awards systems could foster further improvements in surgical evidence. IDEAL has probably contributed only slightly to the improvements described to date, but its uptake is accelerating rapidly. The need for the integrated evaluation template IDEAL offers for surgery and other complex treatments is becoming more widely accepted. Copyright © 2018 Elsevier Ltd. All rights reserved.

  10. Identifying research priorities for effective retention strategies in clinical trials.

    Science.gov (United States)

    Kearney, Anna; Daykin, Anne; Shaw, Alison R G; Lane, Athene J; Blazeby, Jane M; Clarke, Mike; Williamson, Paula; Gamble, Carrol

    2017-08-31

    The failure to retain patients or collect primary-outcome data is a common challenge for trials and reduces the statistical power and potentially introduces bias into the analysis. Identifying strategies to minimise missing data was the second highest methodological research priority in a Delphi survey of the Directors of UK Clinical Trial Units (CTUs) and is important to minimise waste in research. Our aim was to assess the current retention practices within the UK and priorities for future research to evaluate the effectiveness of strategies to reduce attrition. Seventy-five chief investigators of NIHR Health Technology Assessment (HTA)-funded trials starting between 2009 and 2012 were surveyed to elicit their awareness about causes of missing data within their trial and recommended practices for improving retention. Forty-seven CTUs registered within the UKCRC network were surveyed separately to identify approaches and strategies being used to mitigate missing data across trials. Responses from the current practice surveys were used to inform a subsequent two-round Delphi survey with registered CTUs. A consensus list of retention research strategies was produced and ranked by priority. Fifty out of seventy-five (67%) chief investigators and 33/47 (70%) registered CTUs completed the current practice surveys. Seventy-eight percent of trialists were aware of retention challenges and implemented strategies at trial design. Patient-initiated withdrawal was the most common cause of missing data. Registered CTUs routinely used newsletters, timeline of participant visits, and telephone reminders to mitigate missing data. Whilst 36 out of 59 strategies presented had been formally or informally evaluated, some frequently used strategies, such as site initiation training, have had no research to inform practice. Thirty-five registered CTUs (74%) participated in the Delphi survey. Research into the effectiveness of site initiation training, frequency of patient contact

  11. 78 FR 79703 - Submission for OMB Review; 30-Day Comment Request: Application Process for Clinical Research...

    Science.gov (United States)

    2013-12-31

    ... for OMB Review; 30-Day Comment Request: Application Process for Clinical Research Training and Medical... contact: Robert M. Lembo, MD, Deputy Director, Office of Clinical Research Training and Medical Education... Process for Clinical Research Training and Medical Education at the Clinical Center and its Impact on...

  12. NIHR Clinical Research Networks: what they do and how they help paediatric research.

    Science.gov (United States)

    Lythgoe, Hanna; Price, Victoria; Poustie, Vanessa; Attar, Sabah; Hawcutt, Daniel; Preston, Jennifer; Beresford, Michael W

    2017-08-01

    This review provides paediatricians with an update on the new structure of the National Institute for Health Research's (NIHR) Clinical Research Network (CRN): Children and its role within the wider NIHR infrastructure. The network supports delivery of high-quality research within the NHS in England and supports researchers, through provision of staff and resources, with feasibility, site set-up, patient recruitment and study management. Since 2013, over 80% of commercial contract studies running within the UK sat within the UKCRN Portfolio. Of the diverse, increasing portfolio of studies supported by the network, many studies are interventional, with 33% being randomised controlled studies. Recruitment to studies supported by the network through the Children's Portfolio has consistently improved. Over 200 000 participants have been recruited to the Children's Portfolio studies to date, and there are currently approximately 500 studies open to recruitment. The CRN: Children has successfully involved patients and the public in all aspects of study design and delivery, including through the work of Generation R. Challenges remain in conducting paediatric research and the network is committed to supporting Children's research and further building on its achievements to date. Education and engagement of paediatricians within the network and research is important to further improving quality and delivery of paediatric research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  13. Highlights of the 2012 Research Workshop: Using nutrigenomics and metabolomics in clinical nutrition research.

    Science.gov (United States)

    Zeisel, Steven H; Waterland, Robert A; Ordovás, José M; Muoio, Deborah M; Jia, Wei; Fodor, Anthony

    2013-03-01

    The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Research Workshop, "Using Nutrigenomics and Metabolomics in Clinical Nutrition Research," was held on January 21, 2012, in Orlando, Florida. The conference brought together experts in human nutrition who use nutrigenomic and metabolomic methods to better understand metabolic individuality and nutrition effects on health. We are beginning to understand how genetic variation and epigenetic events alter requirements for and responses to foods in our diet (the field of nutrigenetics/nutrigenomics and epigenetics). At the same time, methods for profiling almost all of the products of metabolism in plasma, urine, and tissues (metabolomics) are being refined. The relationships between diet and nutrigenomic-metabolomic profiles, as well as between these profiles and health, are being elucidated, and this will dramatically alter clinical practice in nutrition.

  14. Li-Fraumeni syndrome: report of a clinical research workshop and creation of a research consortium.

    Science.gov (United States)

    Mai, Phuong L; Malkin, David; Garber, Judy E; Schiffman, Joshua D; Weitzel, Jeffrey N; Strong, Louise C; Wyss, Oliver; Locke, Luana; Means, Von; Achatz, Maria Isabel; Hainaut, Pierre; Frebourg, Thierry; Evans, D Gareth; Bleiker, Eveline; Patenaude, Andrea; Schneider, Katherine; Wilfond, Benjamin; Peters, June A; Hwang, Paul M; Ford, James; Tabori, Uri; Ognjanovic, Simona; Dennis, Phillip A; Wentzensen, Ingrid M; Greene, Mark H; Fraumeni, Joseph F; Savage, Sharon A

    2012-10-01

    Li-Fraumeni syndrome (LFS) is a rare dominantly inherited cancer predisposition syndrome that was first described in 1969. In most families, it is caused by germline mutations in the TP53 gene and is characterized by early onset of multiple specific cancers and very high lifetime cumulative cancer risk. Despite significant progress in understanding the molecular biology of TP53, the optimal clinical management of this syndrome is poorly defined. We convened a workshop on November 2, 2010, at the National Institutes of Health in Bethesda, Maryland, bringing together clinicians and scientists, as well as individuals from families with LFS, to review the state of the science, address clinical management issues, stimulate collaborative research, and engage the LFS family community. This workshop also led to the creation of the Li-Fraumeni Exploration (LiFE) Research Consortium. Published by Elsevier Inc.

  15. Use of electronic monitoring in clinical nursing research.

    Science.gov (United States)

    Ailinger, Rita L; Black, Patricia L; Lima-Garcia, Natalie

    2008-05-01

    In the past decade, the introduction of electronic monitoring systems for monitoring medication adherence has contributed to the dialog about what works and what does not work in monitoring adherence. The purpose of this article is to describe the use of the Medication Event Monitoring System (MEMS) in a study of patients receiving isoniazid for latent tuberculosis infection. Three case examples from the study illustrate the data that are obtained from the electronic device compared to self-reports and point to the disparities that may occur in electronic monitoring. The strengths and limitations of using the MEMS and ethical issues in utilizing this technology are discussed. Nurses need to be aware of these challenges when using electronic measuring devices to monitor medication adherence in clinical nursing practice and research.

  16. Research design considerations for chronic pain prevention clinical trials

    DEFF Research Database (Denmark)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C

    2015-01-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations...... for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment...... element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have...

  17. Clinical perspectives of cancer stem cell research in radiation oncology

    International Nuclear Information System (INIS)

    Bütof, Rebecca; Baumann, Michael; Dubrovska, Anna

    2013-01-01

    Radiotherapy has a proven potential to eradicate cancer stem cells which is reflected by its curative potential in many cancer types. Considerable progress has been made in identification and biological characterisation of cancer stem cells during the past years. Recent biological findings indicate significant inter- and intratumoural and functional heterogeneity of cancer stem cells and lead to more complex models which have potential implications for radiobiology and radiotherapy. Clinical evidence is emerging that biomarkers of cancer stem cells may be prognostic for the outcome of radiotherapy in some tumour entities. Perspectives of cancer stem cell based research for radiotherapy reviewed here include their radioresistance compared to the mass of non-cancer stem cells which form the bulk of all tumour cells, implications for image- and non-image based predictive bio-assays of the outcome of radiotherapy and a combination of novel systemic treatments with radiotherapy

  18. Use of media for recruiting clinical research volunteers in Ecuador.

    Science.gov (United States)

    Peñaherrera, Carlos Andrés; Palacios, Michael; Duarte, María Carolina; Santibáñez, Rocío; Tamariz, Leonardo; Palacio, Ana

    2015-12-10

    Up to this date, there are no reports made about the use of media for recruiting research volunteers in Latin American populations. Given the emergence of clinical research in Ecuador, a study of this kind in the local population will be beneficial for future research, and is probably applicable to other countries in the region. Two public calls were made for a cross-sectional study on cognitive function and diabetes. We only included people between 55 and 65 years of age without previous neurocognitive conditions. We invited individuals through interviews on the radio, television broadcasts and local newspapers, along with social media ads. Each individual was asked about the method by which they learned of the project. We calculated the frequency in which each method was reported and a chi-square test was used to assess gender differences in the results. A total of 274 patients were enrolled in the study, 64.2% are women and 35.8% men. We found that 29.93% learned of it from third persons, 20.8% through radio, 8.76% through social media, 8.39% by newspaper, and 5.11% by television, while a remaining 27.01% had not previously heard of the recruitment call. Methods reported varied significantly between men and women (p = 0.03). Traditional media were the most common method of recruitment, with radio interviews being the most frequently reported. Individually, none of them surpassed the frequency of people learning of the project from other people (snowball effect). Social networks play an important role, exceeding certain traditional media. We have described for the first time in Latin America the use of media as methods to recruit volunteers for research, and the importance of project dissemination by the participants to reach more people.

  19. Dementia prevention: shared questions for research and clinical management.

    Science.gov (United States)

    Robertson, Maggie; Brown, Eleanor; Whalley, Lawrence

    2014-02-01

    The emergence of advanced genetic technologies raises many challenges for dementia care and the conduct of related social, behavioural and clinical research. Genetic tests are already used to identify possible participants in dementia prevention trials. These tests are unlike any other in clinical medicine as they have the capacity to predict disease onset after intervals of many years with implications for other family members. Genetic counselling professionals support services in paediatrics, cancer diagnosis and some adult-onset diseases. Their capacity cannot meet the needs for pre- and post-test support of the many "at-risk" families living with late onset dementia. Most dementias are common, complex conditions in which multiple genetic and environmental factors play important and potentially modifiable roles. Large scale prevention studies are needed to test the effectiveness of interventions. Some economy of effort will be achieved by the preferential inclusion of "at-risk" families. Many such families are in contact with dementia care services and will be motivated to participate in prevention studies. However, practice standards and consensus-based guidelines do not yet exist. Support services are not available on a scale sufficient to prevent harm when risk is poorly communicated causing unnecessary psychological morbidity in unaffected family members. There is a pressing need for research to inform the development of study guidelines and to identify how services are strengthened to support these families during and after their participation in trials. Discourse analysis provides a useful method to collect and analyse data of this type and supports the conclusions of this review. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  20. The role of operational research in clinical chemistry

    Science.gov (United States)

    Peto, J.; Whitby, L. G.; Finney, D. J.

    1972-01-01

    This paper begins with a critical examination of the published account (Carruthers, 1970) of a pioneering study of simulation in a clinical chemistry laboratory. It next considers the basic requirements for the formal mathematical description of such a laboratory: these include the setting of criteria, the resource and input variates, and the definition of success by means of criterion variates. Investigation of criterion variates can be by direct measurement, or by a theoretical approach which may include simulation. The aims of simulation are discussed and an attempt to simulate the operation of a large clinical chemistry laboratory is described. The difficulty of constructing an overall measure of efficiency is considered in relation to improving performance within an existing framework, to evaluating new equipment such as computers on-line to laboratory apparatus, and to inter-laboratory comparisons of performance. It is concluded that complex operational research techniques, including simulation, have little to offer at least for the present, and may even lead to misleading conclusions. PMID:4648545

  1. Major clinical research advances in gynecologic cancer in 2014.

    Science.gov (United States)

    Suh, Dong Hoon; Lee, Kyung Hun; Kim, Kidong; Kang, Sokbom; Kim, Jae Weon

    2015-04-01

    In 2014, 9 topics were selected as major advances in clinical research for gynecologic oncology: 2 each in cervical and corpus cancer, 4 in ovarian cancer, and 1 in breast cancer. For cervical cancer, several therapeutic agents showed viable antitumor clinical response in recurrent and metastatic disease: bevacizumab, cediranib, and immunotherapies including human papillomavirus (HPV)-tumor infiltrating lymphocytes and Z-100. The HPV test received FDA approval as the primary screening tool of cervical cancer in women aged 25 and older, based on the results of the ATHENA trial, which suggested that the HPV test was a more sensitive and efficient strategy for cervical cancer screening than methods based solely on cytology. For corpus cancers, results of a phase III Gynecologic Oncology Group (GOG) 249 study of early-stage endometrial cancer with high-intermediate risk factors are followed by the controversial topic of uterine power morcellation in minimally invasive gynecologic surgery. Promising results of phase II studies regarding the effectiveness of olaparib in various ovarian cancer settings are summarized. After a brief review of results from a phase III study on pazopanib maintenance therapy in advanced ovarian cancer, 2 outstanding 2014 ASCO presentations cover the topic of using molecular subtypes in predicting response to bevacizumab. A review of the use of opportunistic bilateral salpingectomy as an ovarian cancer preventive strategy in the general population is presented. Two remarkable studies that discussed the effectiveness of adjuvant ovarian suppression in premenopausal early breast cancer have been selected as the last topics covered in this review.

  2. [Three-dimensional cephalometry: applications in clinical practice and research].

    Science.gov (United States)

    Faure, Jacques; Oueiss, Arlette; Marchal-Sixou, Christine; Braga, José; Treil, Jacques

    2008-03-01

    A 3D cephalometric analysis method from scanner acquisition has been developed thanks to a long collaboration between Dr Treil and the Department of Orthodontics in Toulouse III University. It allows a perfect knowledge of maxillo-facial architecture using fourteen landmarks related to the neuromatricial axis of facial growth. These landmarks can be identified without ambiguity. The marking of each tooth relative to dental arches (gravity centre coordinates and torque and tipping of each tooth), and the location of arches relative to maxillo-facial frame are given by the analysis. Description and reconstruction of dental and maxillo-facial anatomy are possible with three levels: maxillo-facial frame, maxillar and mandibular bases and dentoalveolar level. The method not only gives more precise information than conventional cephalometrics in anteroposterior and vertical directions, but it allows transversal analysis and asymmetry measurement. Applications are numerous in research as well as in clinical medicine: analyses of cases border line surgery, surgical set-up, facial asymmetry, analysis of dentoalveolar compensations, definition of therapeutic aims, occlusal analysis and set-up, study of evolution in anthropology-primatology, study of growth etc. This method of description using a pattern of landmarks is perfectly adapted to the last developments of modern research techniques: morphometric geometry with Procustes superimpositions, EDMA, TPS, FEM.

  3. After the clinic? Researching sexual health technology in context.

    Science.gov (United States)

    Davis, Mark

    2015-01-01

    There is great interest in what testing, pharmaceutical, information and social media technology can do for sexual health. Much programmatic and research activity is focused on assessing how these technologies can be used to best effect. Less obvious are analyses that place technology into historical, political and real-world settings. Developing an 'in-context' analysis of sexual health technology, this paper draws on interviews with leading community advocates, researchers and clinicians in Australia, Canada and the UK and looks across examples, including social media, rapid HIV testing, pre-Exposure Prophylaxis for HIV and polymerase chain reaction Chlamydia testing. The analysis is framed by studies of techno-society and the dialectics of sex-affirmative advocacy with biomedical authority and attends to: the rationalistic and affective dimensions of the imaginary associated with technology; the role of technology in the re-spatialisation and re-temporalisation of the sexual health clinic; and the re-invention of technology in its real-world contexts. This in-context approach is important for: the effective implementation of new technology; strengthening the social science contribution to the field; and enriching social theory in general on life in techno-societies.

  4. Major clinical research advances in gynecologic cancer in 2014

    Science.gov (United States)

    Lee, Kyung-Hun; Kim, Kidong; Kang, Sokbom

    2015-01-01

    In 2014, 9 topics were selected as major advances in clinical research for gynecologic oncology: 2 each in cervical and corpus cancer, 4 in ovarian cancer, and 1 in breast cancer. For cervical cancer, several therapeutic agents showed viable antitumor clinical response in recurrent and metastatic disease: bevacizumab, cediranib, and immunotherapies including human papillomavirus (HPV)-tumor infiltrating lymphocytes and Z-100. The HPV test received FDA approval as the primary screening tool of cervical cancer in women aged 25 and older, based on the results of the ATHENA trial, which suggested that the HPV test was a more sensitive and efficient strategy for cervical cancer screening than methods based solely on cytology. For corpus cancers, results of a phase III Gynecologic Oncology Group (GOG) 249 study of early-stage endometrial cancer with high-intermediate risk factors are followed by the controversial topic of uterine power morcellation in minimally invasive gynecologic surgery. Promising results of phase II studies regarding the effectiveness of olaparib in various ovarian cancer settings are summarized. After a brief review of results from a phase III study on pazopanib maintenance therapy in advanced ovarian cancer, 2 outstanding 2014 ASCO presentations cover the topic of using molecular subtypes in predicting response to bevacizumab. A review of the use of opportunistic bilateral salpingectomy as an ovarian cancer preventive strategy in the general population is presented. Two remarkable studies that discussed the effectiveness of adjuvant ovarian suppression in premenopausal early breast cancer have been selected as the last topics covered in this review. PMID:25872896

  5. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

    DEFF Research Database (Denmark)

    Kubiak, Christine; de Andres-Trelles, Fernando; Kuchinke, Wolfgang

    2009-01-01

    BACKGROUND: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. METHODS: In order to summarise the current situation...... in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching...... an agreement on a common classification was the initial step in the development of the survey. RESULTS: The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant...

  6. Revisioning Clinical Psychology: Integrating Cultural Psychology into Clinical Research and Practice with Portuguese Immigrants

    Science.gov (United States)

    James, Susan; Harris, Sara; Foster, Gary; Clarke, Juanne; Gadermann, Anne; Morrison, Marie; Bezanson, Birdie Jane

    2013-01-01

    This article outlines a model for conducting psychotherapy with people of diverse cultural backgrounds. The theoretical foundation for the model is based on clinical and cultural psychology. Cultural psychology integrates psychology and anthropology in order to provide a complex understanding of both culture and the individual within his or her cultural context. The model proposed in this article is also based on our clinical experience and mixed-method research with the Portuguese community. The model demonstrates its value with ethnic minority clients by situating the clients within the context of their multi-layered social reality. The individual, familial, socio-cultural, and religio-moral domains are explored in two research projects, revealing the interrelation of these levels/contexts. The article is structured according to these domains. Study 1 is a quantitative study that validates the Agonias Questionnaire in Ontario. The results of this study are used to illustrate the individual domain of our proposed model. Study 2 is an ethnography conducted in the Azorean Islands, and the results of this study are integrated to illustrate the other three levels of the model, namely family, socio-cultural, and the religio-moral levels. PMID:23720642

  7. Pharmacokinetic studies of neuromuscular blocking agents: Good Clinical Research Practice (GCRP)

    DEFF Research Database (Denmark)

    Viby-Mogensen, J.; Østergaard, D.; Donati, F.

    2000-01-01

    Good Clinical Research Practice (GCRP), neuromuscular blocking agents, pharmacokinetics, pharmacokinetic/pharmacodynamic modeling, population pharmacokinetics, statistics, study design......Good Clinical Research Practice (GCRP), neuromuscular blocking agents, pharmacokinetics, pharmacokinetic/pharmacodynamic modeling, population pharmacokinetics, statistics, study design...

  8. Who discovered the sylvian fissure?

    Science.gov (United States)

    Collice, Massimo; Collice, Rosa; Riva, Alessandro

    2008-10-01

    Cerebral convolutions were unknown until the 17th century. A constant sulcus was not recognized until the mid-1600s; it was named "the fissure of Sylvius," after the person who had always been considered as the one who discovered it. It is commonly asserted that the first description of the lateral scissure was made by Caspar Bartholin, who attributed its discovery to Sylvius. However, this was not actually the case, as Caspar Bartholin died in 1629, whereas Sylvius started studying medicine in 1632. The description could have been made either by Caspar Bartholin's son Thomas or by Sylvius himself. Irrespective of the description's author, the key to the history of the lateral fissure is that it was first identified by Fabrici d'Acquapendente in 1600, 40 years before Sylvius' description. In one of the 300 colored plates (Tabulae Pictae) by Fabrici, the lateral fissure is perfectly depicted, as are the temporal convolutions. Therefore, even if it was an accidental discovery, Fabrici should be the one noted as having discovered the fissure. This article ends with a short history of the plates. They were painted in oil on paper and were thought to further a great work, the Theatrum Totius Animalis Fabricae, which was begun in 1591 and never completed or published. Only the colored illustrations of this project remain. These plates were forgotten for more than 200 years, until they were rediscovered by Giuseppe Sterzi in 1909. They are among the best examples of anatomic iconography in terms of innovation, accuracy, and artistic accomplishment.

  9. [Introduction to Research Electronic Data Capture (REDCap) and REDCap2SDTM, a Conversion Tool to Facilitate Clinical Research Data Sharing].

    Science.gov (United States)

    Yamamoto, Keiichi

    2017-07-01

    Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) is used in new drug application studies and for sharing and reuse of accumulated clinical research data. Clinical trial manuscripts submitted to International Committee of Medical Journal Editors member journals are required to contain a statement on data sharing. We introduce here Research Electronic Data Capture (REDCap) and REDCap2SDTM, a tool for converting research data to CDISC SDTM for facilitating data sharing. This tool will help reduce the workload in new drug application studies and allow the effective reuse of clinical research data.

  10. Laboratory research at the clinical trials of Veterinary medicinal Products

    OpenAIRE

    ZHYLA M.I.

    2011-01-01

    The article analyses the importance of laboratory test methods, namely pathomorfological at conduct of clinical trials. The article focuses on complex laboratory diagnostics at determination of clinical condition of animals, safety and efficacy of tested medicinal product.

  11. Clinical research priorities in emergency medicine: results of a consensus meeting and development of a weighting method for assessment of clinical research priorities.

    Science.gov (United States)

    Thom, Ogilvie; Keijzers, Gerben; Davies, Suzanne; McD Taylor, David; Knott, Jonathan; Middleton, Paul M

    2014-02-01

    There is limited evidence regarding clinical research priorities in emergency medicine outside of some special interest groups. The ACEM Clinical Trials Group undertook a consensus meeting with the aim of developing a reproducible weighting matrix for assessing clinical research priorities. A session at the ACEM annual scientific meeting was dedicated to this meeting. Results from a survey of the ACEM researcher database were presented, along with a proposed weighting matrix. After discussion and adjustment, consensus was achieved on the matrix. It was agreed that the following criteria be used in the matrix: research category and sub-category priority ranking from the ACEM researcher database survey, frequency of presentation of potentially eligible participants, the level of pre-existing evidence regarding the proposed research question and the likely clinical impact of the research. Each criterion was given a weighting, with clinical impact given the heaviest weighting. The weighting matrix was subsequently applied to the list of research questions that resulted from the researcher database survey and a list of research priorities determined. The weighting matrix allows reproducible comparison of research questions. The resultant list of research priorities will act as a guide for the ACEM Clinical Trials Group in determining future projects. © 2014 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  12. Informationist role: clinical data management in auditory research

    Directory of Open Access Journals (Sweden)

    Karen L. Hanson

    2013-05-01

    Full Text Available Informationists at NYU Health Sciences Libraries (NYUHSL successfully applied for a NLM supplement to a translational research grant obtained by PIs in the NYU School of Medicine Department of Otolaryngology titled, “Clinical Management of Cochlear Implant Patients with Contralateral Hearing Aids”. The grant involves development of evidence-based guidelines for post-implant management of patients with bimodal cochlear implants. The PIs are also seeking to acquire new data sets to merge with grant-generated data. In light of the shifting data requirements, and the potential introduction of additional datasets, informationists will evaluate and restructure the data model and data entry tool. Report queries will be refined for the new data model and options for a query tool appropriate for users unfamiliar with query languages will be assessed and implemented. The services offered through this supplement represent the deepest and most detailed data management support offered by NYUHSL to date. The components of the supplement are being analyzed as a pilot of a broader offering of these data management services.

  13. Ontology-based data integration between clinical and research systems.

    Directory of Open Access Journals (Sweden)

    Sebastian Mate

    Full Text Available Data from the electronic medical record comprise numerous structured but uncoded elements, which are not linked to standard terminologies. Reuse of such data for secondary research purposes has gained in importance recently. However, the identification of relevant data elements and the creation of database jobs for extraction, transformation and loading (ETL are challenging: With current methods such as data warehousing, it is not feasible to efficiently maintain and reuse semantically complex data extraction and trans-formation routines. We present an ontology-supported approach to overcome this challenge by making use of abstraction: Instead of defining ETL procedures at the database level, we use ontologies to organize and describe the medical concepts of both the source system and the target system. Instead of using unique, specifically developed SQL statements or ETL jobs, we define declarative transformation rules within ontologies and illustrate how these constructs can then be used to automatically generate SQL code to perform the desired ETL procedures. This demonstrates how a suitable level of abstraction may not only aid the interpretation of clinical data, but can also foster the reutilization of methods for un-locking it.

  14. Automation of steroid radioimmunoassays for clinical and research purposes

    International Nuclear Information System (INIS)

    Vihko, R.; Hammond, G.L.

    1979-01-01

    In recent years an exponential increase in the research and clinical application of radioimmunoassays has created a demand for manipulative aids, to increase the general efficiency of the technique as well as precision of the determinations. At present a number of systems exist for sample preparation and the automation of assays. However, due to inherent problems of carry-over, priming, cleaning and the necessity for chemically inert components most of these systems tend to be rather inflexible. The instrument of choice ought therefore to be extremely versatile and provide the operator with a wide spectrum of alternatives, in order to optimize the initial capital outlay. Moreover, in the light of technological developments in the field of simultaneous, multisample gamma-counting and data processing, it is anticipated that a new generation of multisample processors will emerge of sufficient flexibility to accommodate the wide variety of assay protocols in present use. In this paper the problems encountered in the development of automated techniques for the radioimmunoassay of steroid hormones are reviewed, and a preliminary description of a versatile modular discrete instrument for the automation of radioimmunoassays is presented, which is based on simultaneous multisample preparation, and subsequent counting and data processing. (author)

  15. How Can a Clinical Research Approach Contribute to Knowledge-Building for the Teaching Profession?

    Science.gov (United States)

    Bulterman-Bos, Jacquelien

    2017-01-01

    This article explains what clinical research is and why it is necessary. The term "clinical" refers to an academic way of solving practical problems. Clinical research starts from a view of science that not only acknowledges the value of rational analysis and empirical research, but also acknowledges the need for human skills and…

  16. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

    LENUS (Irish Health Repository)

    Kubiak, Christine

    2009-10-16

    Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the

  17. ClinicalCodes: an online clinical codes repository to improve the validity and reproducibility of research using electronic medical records.

    Directory of Open Access Journals (Sweden)

    David A Springate

    Full Text Available Lists of clinical codes are the foundation for research undertaken using electronic medical records (EMRs. If clinical code lists are not available, reviewers are unable to determine the validity of research, full study replication is impossible, researchers are unable to make effective comparisons between studies, and the construction of new code lists is subject to much duplication of effort. Despite this, the publication of clinical codes is rarely if ever a requirement for obtaining grants, validating protocols, or publishing research. In a representative sample of 450 EMR primary research articles indexed on PubMed, we found that only 19 (5.1% were accompanied by a full set of published clinical codes and 32 (8.6% stated that code lists were available on request. To help address these problems, we have built an online repository where researchers using EMRs can upload and download lists of clinical codes. The repository will enable clinical researchers to better validate EMR studies, build on previous code lists and compare disease definitions across studies. It will also assist health informaticians in replicating database studies, tracking changes in disease definitions or clinical coding practice through time and sharing clinical code information across platforms and data sources as research objects.

  18. ICPC Pilots International Student Training, Paving a Path for Tomorrow’s Cancer Researchers | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The Office of Cancer Clinical Proteomics Research at the National Cancer Institute, part of the United States National Institutes of Health, is spearheading the preparationand training of the proteogenomic research workforce on an international scale.

  19. Continuing Education in Research Ethics for the Clinical Nurse.

    Science.gov (United States)

    Jeffers, Brenda Recchia

    2002-01-01

    Review of professional nursing statements, federal policy, and recommendations for protection of human research subjects resulted in a topic and content outline for research ethics training for nurses. Suggestions for continuing education programs on research ethics were formulated. (SK)

  20. [Cancer treatment in elderly patients: evidence and clinical research].

    Science.gov (United States)

    Repetto, Lazzaro; Luciani, Andrea

    2015-01-01

    showed a good sensibility (87.3%) but a low specificity (62%) with respect to CGA for the diagnosis of patients with disabilities. Overcash et al. proposed an abbreviated form of CGA using a reduced number of items of ADL, IADL, MMSE and GDS. There was a good correlation between complete and reduced scales (coefficient of correlation 0.8). G8 is a screening tool composed of 8 questions that explore functional, cognitive and nutritional status. The score with the best equilibrium between sensibility and specificity was 14 (sensibility 85% and specificity 65%). In the first observational trial age, hystotype, chemotherapy dose, haemoglobin (man: 11 g/dL; women: 10 g/dL), creatinine clearance less than 34 mL/min (Jelliffe formula), earing problems, at least a fall in the last six months, walking problems, low social activity, were related to a major risk of toxicity; in another trial IADL, diastolic blood pressure, LDH and MAX2 index were predictive of haematological toxicity, while performance status, Mini-Mental Status score, Mini-Nutritional Assessment (MNA) score and MAX2 index were predictive of non haematological toxicity. Based on these parameters a 0-2 score was developed. A recent "position article" of EORTC (European organization for Research and Treatment of Cancer) and SIOG analyzed the pro and the contra of the use of some indicators in elderly patients. The overall survival (OS) frequently used in classical clinical trial could give wrong messages as there are some competitive risks of death in elderly patients. Another important indicator is the disease specific survival (DSS). Concerning the design of clinical trials, a possible strategy is to enrol elderly patients without upper age limit and to plan stratification. An interesting trial design is the so called "extended trial" that allow to re-open the arm of a trial in which a too low number of older patients was enrolled.

  1. Research on clinical ethics and consultation. Introduction to the theme.

    Science.gov (United States)

    Reiter-Theil, Stella; Agich, George J

    2008-03-01

    Clinical ethics consultation has developed from local pioneer projects into a field of growing interest among both clinicians and ethicists. What is needed are more systematic studies on the ethical challenges faced in clinical practice and problem solving through ethics consultation from interdisciplinary perspectives. The Thematic Issue covers a range of topics and includes five recent studies from various European countries and the USA, focusing on issues such as the ethical difficulties of end of life decisions, experiences with newly developed or well established ethics consultation services, and the expectations of physicians in various clinical fields who are still unfamiliar with clinical ethics consultation. The papers included illustrate the interface between different socio-cultural contexts and their ways of dealing with clinical ethics consultation. They deepen the dialogue on clinical ethics consultation that has emerged at the European and International level.

  2. Major clinical research advances in gynecologic cancer in 2017.

    Science.gov (United States)

    Suh, Dong Hoon; Kim, Miseon; Lee, Kyung Hun; Eom, Keun Yong; Kjeldsen, Maj Kamille; Mirza, Mansoor Raza; Kim, Jae Weon

    2018-03-01

    In 2017, 10 topics were selected as major clinical research advances in gynecologic oncology. For cervical cancer, efficacy and safety analysis results of a 9-valent human papillomavirus (HPV) vaccine and long-term impact of reduced dose of quadrivalent vaccine were updated. Brief introduction of KEYNOTE trials of pembrolizumab, a monoclonal antibody that blocks the interaction between programmed death (PD)-1 and its ligands, PD-L1 and PD-L2, followed. Tailored surveillance programs for gynecologic cancer related with Lynch syndrome and update on sentinel lymph node mapping were reviewed for uterine corpus cancer. For ovarian cancer, 5 topics were selected including poly(ADP-ribose) polymerases inhibitors and immunotherapy. The other potential practice changers covered in this review were lymphadenectomy in advanced disease, secondary cytoreductive surgery in recurrent disease, weekly dose-dense regimen for first-line chemotherapy, incorporation of bevacizumab maintenance in platinum-sensitive recurrent disease, and effect of platinum-free interval prolongation. Conflicting opinions of academic societies on periodic pelvic examination were introduced in conjunction with relevant literature review. For the field of radiation oncology, results of 2 big trials, The Postoperative Radiation Therapy in Endometrial Carcinoma-3 and Gynecologic Oncology Group-258, for endometrial cancer and recent advance in high-dose-rate brachytherapy for cervical cancer were reported. Topics for breast cancer covered adjuvant capecitabine after preoperative chemotherapy, adjuvant pertuzumab and trastuzumab in early human epidermal growth factor receptor 2-positive disease, olaparib for metastatic cancer in patients with a germline BRCA mutation, 20-year risks of recurrence after stopping endocrine therapy at 5 years, and contemporary hormonal contraception and the risk of breast cancer. Copyright © 2018. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.

  3. Merging genomic and phenomic data for research and clinical impact.

    Science.gov (United States)

    Shublaq, Nour W; Coveney, Peter V

    2012-01-01

    Driven primarily by advances in genomics, pharmacogenomics and systems biology technologies, large amounts of genomic and phenomic data are today being collected on individuals worldwide. Integrative analysis, mining, and computer modeling of these data, facilitated by information technology, have led to the development of predictive, preventive, and personalized medicine. This transformative approach holds the potential inter alia to enable future general practitioners and physicians to prescribe the right drug to the right patient at the right dosage. For such patient-specific medicine to be adopted as standard clinical practice, publicly accumulated knowledge of genes, proteins, molecular functional annotations, and interactions need to be unified and with electronic health records including phenotypic information, most of which still reside as paper-based records in hospitals. We review the state-of-the-art in terms of electronic data capture and medical data standards. Some of these activities are drawn from research projects currently being performed within the European Virtual Physiological Human (VPH) initiative; all are being monitored by the VPH INBIOMEDvision Consortium. Various ethical, legal and societal issues linked with privacy will increasingly arise in the post-genomic era. This will require a closer interaction between the bioinformatics/systems biology and medical informatics/healthcare communities. Planning for how individuals will own their personal health records is urgently needed, as the cost of sequencing a whole human genome will soon be less than U.S. $100. We discuss some of the issues that will need to be addressed by society as a result of this revolution in healthcare.

  4. Discovering, Indexing and Interlinking Information Resources.

    Science.gov (United States)

    Celli, Fabrizio; Keizer, Johannes; Jaques, Yves; Konstantopoulos, Stasinos; Vudragović, Dušan

    2015-01-01

    The social media revolution is having a dramatic effect on the world of scientific publication. Scientists now publish their research interests, theories and outcomes across numerous channels, including personal blogs and other thematic web spaces where ideas, activities and partial results are discussed. Accordingly, information systems that facilitate access to scientific literature must learn to cope with this valuable and varied data, evolving to make this research easily discoverable and available to end users. In this paper we describe the incremental process of discovering web resources in the domain of agricultural science and technology. Making use of Linked Open Data methodologies, we interlink a wide array of custom-crawled resources with the AGRIS bibliographic database in order to enrich the user experience of the AGRIS website. We also discuss the SemaGrow Stack, a query federation and data integration infrastructure used to estimate the semantic distance between crawled web resources and AGRIS.

  5. World Endometriosis Research Foundation Endometriosis Phenome and biobanking harmonization project: II. Clinical and covariate phenotype data collection in endometriosis research

    DEFF Research Database (Denmark)

    Vitonis, Allison F.; Vincent, Katy; Rahmioglu, Nilufer

    2014-01-01

    ObjectiveTo harmonize the collection of nonsurgical clinical and epidemiologic data relevant to endometriosis research, allowing large-scale collaboration.......ObjectiveTo harmonize the collection of nonsurgical clinical and epidemiologic data relevant to endometriosis research, allowing large-scale collaboration....

  6. A survey of attitudes toward clinical research among physicians at Kyoto University Hospital.

    Science.gov (United States)

    Sumi, Eriko; Murayama, Toshinori; Yokode, Masayuki

    2009-12-22

    In Japan, only clinical research related to investigational new drug trials must be notified to regulatory bodies, and this lack of a uniform standard for clinical research has caused a number of difficulties. The objective of this study was to assess the willingness of physicians to participate in clinical research and to identify effective methods to promote and enhance clinical research. We conducted a cross-sectional survey by administrating questionnaires to physicians in 31 departments in Kyoto University Hospital from October through November 2007. A total of 51.5% (310 of 602) of physicians completed the questionnaire. More than two-thirds of them reported currently participating in clinical research, and nearly all believed that clinical research is necessary for physicians. Less than 20% of respondents had specific training regarding clinical research, and most reported a need to acquire concepts and skills regarding clinical research, especially those related to statistics. "Paperwork was complicated and onerous" was the most frequently cited obstacle in conducting clinical research, followed by "few eligible patients" and "lack of time". Previous participation in and prospective participation in clinical research, previous writing a research protocol were positively associated with current participation in clinical research. Physicians in university hospitals need more training regarding clinical research, particularly in biostatistics. They also require administrative assistance. Our findings indicate that the quality of clinical research could be improved if training in clinical research methodology and biostatistics were provided, and if greater assistance in the preparation of study documents requested by the institutional Independent Ethics Committee were available.

  7. A survey of attitudes toward clinical research among physicians at Kyoto University Hospital

    Directory of Open Access Journals (Sweden)

    Yokode Masayuki

    2009-12-01

    Full Text Available Abstract Background In Japan, only clinical research related to investigational new drug trials must be notified to regulatory bodies, and this lack of a uniform standard for clinical research has caused a number of difficulties. The objective of this study was to assess the willingness of physicians to participate in clinical research and to identify effective methods to promote and enhance clinical research. Methods We conducted a cross-sectional survey by administrating questionnaires to physicians in 31 departments in Kyoto University Hospital from October through November 2007. Results A total of 51.5% (310 of 602 of physicians completed the questionnaire. More than two-thirds of them reported currently participating in clinical research, and nearly all believed that clinical research is necessary for physicians. Less than 20% of respondents had specific training regarding clinical research, and most reported a need to acquire concepts and skills regarding clinical research, especially those related to statistics. "Paperwork was complicated and onerous" was the most frequently cited obstacle in conducting clinical research, followed by "few eligible patients" and "lack of time". Previous participation in and prospective participation in clinical research, previous writing a research protocol were positively associated with current participation in clinical research. Conclusions Physicians in university hospitals need more training regarding clinical research, particularly in biostatistics. They also require administrative assistance. Our findings indicate that the quality of clinical research could be improved if training in clinical research methodology and biostatistics were provided, and if greater assistance in the preparation of study documents requested by the institutional Independent Ethics Committee were available.

  8. Discovering Self: Childbearing Adolescents' Maternal Identity.

    Science.gov (United States)

    Macintosh, Janelle; Callister, Lynn Clark

    2015-01-01

    Adolescent pregnancy and motherhood have long been a topic of interest for many healthcare professionals. However, there are limited data on how childbearing adolescents incorporate motherhood identity into their sense of self. The purpose of this study was to explore how childbearing adolescents perceive motherhood as becoming part of their personal identity. This qualitative study using ethnographic data collection involved 7 months of observation, interaction, and interviews. Data were collected from nine expectant adolescents during in-depth interviews. All participants were patients at a teen mother and child clinic staffed by certified nurse midwives and a pediatrician. Narrative content analysis revealed the overall theme of discovering self, with three major themes: confirming the pregnancy, the loss of my body, and imagining my child in my arms. Adolescent mothers may need assistance to construct their maternal identity in order to strengthen self-perceptions and improve maternal/child outcomes.

  9. How to estimate the health benefits of additional research and changing clinical practice

    NARCIS (Netherlands)

    Claxton, Karl; Griffin, Susan; Koffijberg, Hendrik; McKenna, Claire

    2015-01-01

    A simple extension of standard metaanalysis can provide quantitative estimates of the potential health benefits of further research and of implementing the findings of existing research, which can help inform research prioritisation and efforts to change clinical practice

  10. Foreign Language Short Course: Special Operations Clinical Research Fundamentals.

    Science.gov (United States)

    Rocklein-Kemplin, Kate; Bowling, F

    When we do not know a language, we are at the mercy of an interpreter. The same is true for research: Special Operations Forces (SOF) clinicians not actively involved in research initiatives may rely on scientific interpreters, so it is important to speak some of the language personally. For any clinician, using evidence in practice requires a working knowledge of how that evidence was generated from research, which requires an understanding of research science language. Here we review common basics of research science to reinforce concepts and elements of experimental and nonexperimental research. 2017.

  11. Navigating the research-clinical interface in genomic medicine: analysis from the CSER Consortium.

    Science.gov (United States)

    Wolf, Susan M; Amendola, Laura M; Berg, Jonathan S; Chung, Wendy K; Clayton, Ellen Wright; Green, Robert C; Harris-Wai, Julie; Henderson, Gail E; Jarvik, Gail P; Koenig, Barbara A; Lehmann, Lisa Soleymani; McGuire, Amy L; O'Rourke, Pearl; Somkin, Carol; Wilfond, Benjamin S; Burke, Wylie

    2017-08-31

    PurposeThe Clinical Sequencing Exploratory Research (CSER) Consortium encompasses nine National Institutes of Health-funded U-award projects investigating translation of genomic sequencing into clinical care. Previous literature has distinguished norms and rules governing research versus clinical care. This is the first study to explore how genomics investigators describe and navigate the research-clinical interface.MethodsA CSER working group developed a 22-item survey. All nine U-award projects participated. Descriptive data were tabulated and qualitative analysis of text responses identified themes and characterizations of the research-clinical interface.ResultsSurvey responses described how studies approached the research-clinical interface, including in consent practices, recording results, and using a research versus clinical laboratory. Responses revealed four characterizations of the interface: clear separation between research and clinical care, interdigitation of the two with steps to maintain separation, a dynamic interface, and merging of the two. All survey respondents utilized at least two different characterizations. Although research has traditionally been differentiated from clinical care, respondents pointed to factors blurring the distinction and strategies to differentiate the domains.ConclusionThese results illustrate the difficulty in applying the traditional bifurcation of research versus clinical care to translational models of clinical research, including in genomics. Our results suggest new directions for ethics and oversight.Genetics in Medicine advance online publication, 31 August 2017; doi:10.1038/gim.2017.137.

  12. Discovering Data in the Virtual Observatory

    Science.gov (United States)

    Donaldson, Tom; Hinshaw, D.; Rogers, A.; Wallace, G.

    2013-01-01

    We present the VAO Data Discovery Tool, a web-based application for discovering data from thousands of astronomical collections and archives around the world. Using protocols defined by the International Virtual Observatory Alliance (IVOA), the Data Discovery Tool can search those widely distributed resources and present the results in a single unified web page. A powerful filtering mechanism allows the user to quickly narrow the initial results to a short list of likely applicable data. Guidance on choosing appropriate data sets is provided by a variety of integrated displays, including an interactive data table, basic histograms and scatter plots, and an all-sky browser/visualizer with observation and catalog overlays. Data discovered through the tool can be downloaded or exported directly to other VO-aware tools for further analysis. The VAO Data Discovery Tool is being developed as a joint effort between the Mikulski Archive for Space Telescopes (MAST) and the Virtual Astronomical Observatory (VAO). MAST is a NASA funded project to support and provide to the astronomical community a variety of astronomical data archives, and is located at the Space Telescope Science Institute (STScI). The VAO was established as a partnership of the Associated Universities, Inc. and the Association of Universities for Research in Astronomy, Inc. The VAO is sponsored by the National Science Foundation and the National Aeronautics and Space Administration.

  13. Engaging adolescents in tuberculosis and clinical trial research through drama.

    Science.gov (United States)

    Schmidt, Bey-Marrié; Abrams, Amber; Tameris, Michele

    2016-04-06

    The South African Tuberculosis Vaccine Initiative is based in Worcester where tuberculosis (TB) is endemic, and incidence rates are amongst the highest nationally. In high TB burden settings after an early childhood peak, incidence rates start to rise again in adolescents, therefore they are an important target group for tuberculosis vaccine research. In 2012, learners from a local school developed a one-off theatrical production out of an educational comic book Carina's Choice, developed by the South African Tuberculosis Vaccine Initiative in 2010. A Wellcome Trust International Engagement grant allowed for this one-off production to be further developed, with input from university students and staff, and rolled out to schools in the Worcester area as an engagement and education intervention. Focus group feedback was used to identify key messages and to develop the play's script. Qualitative methods were used to collect and analyse relevant data. Interviews were conducted with learner-actors, pre- and post-focus group feedback was obtained from a sample of school-going adolescents, and pre- and post-questionnaires were administered to adolescent audience members. From the pre-drama focus group discussions, topics such as TB symptoms, stigma and transmission were identified as areas that needed attention. After the performances, adolescents showed improved knowledge on the identified topics and they discussed TB prevention measures. They highlighted transmission of TB during pregnancy as a further topic to be addressed in future iterations of the drama. Although stigma is a difficult phenomenon to interpret, post-drama participants understood that TB transmission could occur in all individuals. Learner-actors agreed with focus group participants that the play could impact the wider community if it were rolled out. Feedback from the South African Tuberculosis Vaccine Initiative staff verified that recruitment for an upcoming trial was facilitated by the preparedness

  14. Longitudinal Omics Modelling and Integration in Clinical Metabonomics Research: challenges in childhood metabolic health research

    Directory of Open Access Journals (Sweden)

    Peter eSperisen

    2015-08-01

    Full Text Available Systems biology is an important approach for deciphering the complex processes in health maintenance and the etiology of metabolic diseases. Such integrative methodologies will help better understand the molecular mechanisms involved in growth and development throughout childhood, and consequently will result in new insights about metabolic and nutritional requirements of infants, children and adults. To achieve this, a better understanding of the physiological processes at anthropometric, cellular and molecular level for any given individual is needed. In this respect, novel omics technologies in combination with sophisticated data modelling techniques are key. Due to the highly complex network of influential factors determining individual trajectories, it becomes imperative to develop proper tools and solutions that will comprehensively model biological information related to growth and maturation of our body functions. The aim of this review and perspective is to evaluate, succinctly, promising data analysis approaches to enable data integration for clinical research, with an emphasis on the longitudinal component. Approaches based on empirical and mechanistic modelling of omics data are essential to leverage findings from high dimensional omics datasets and enable biological interpretation and clinical translation. On the one hand, empirical methods, which provide quantitative descriptions of patterns in the data, are mostly used for exploring and mining datasets. On the other hand, mechanistic models are based on an understanding of the behavior of a system’s components and condense information about the known functions, allowing robust and reliable analyses to be performed by bioinformatics pipelines and similar tools. Herein, we will illustrate current examples, challenges and perspectives in the applications of empirical and mechanistic modelling in the context of childhood metabolic health research.

  15. Longitudinal omics modeling and integration in clinical metabonomics research: challenges in childhood metabolic health research

    Science.gov (United States)

    Sperisen, Peter; Cominetti, Ornella; Martin, François-Pierre J.

    2015-01-01

    Systems biology is an important approach for deciphering the complex processes in health maintenance and the etiology of metabolic diseases. Such integrative methodologies will help better understand the molecular mechanisms involved in growth and development throughout childhood, and consequently will result in new insights about metabolic and nutritional requirements of infants, children and adults. To achieve this, a better understanding of the physiological processes at anthropometric, cellular and molecular level for any given individual is needed. In this respect, novel omics technologies in combination with sophisticated data modeling techniques are key. Due to the highly complex network of influential factors determining individual trajectories, it becomes imperative to develop proper tools and solutions that will comprehensively model biological information related to growth and maturation of our body functions. The aim of this review and perspective is to evaluate, succinctly, promising data analysis approaches to enable data integration for clinical research, with an emphasis on the longitudinal component. Approaches based on empirical and mechanistic modeling of omics data are essential to leverage findings from high dimensional omics datasets and enable biological interpretation and clinical translation. On the one hand, empirical methods, which provide quantitative descriptions of patterns in the data, are mostly used for exploring and mining datasets. On the other hand, mechanistic models are based on an understanding of the behavior of a system's components and condense information about the known functions, allowing robust and reliable analyses to be performed by bioinformatics pipelines and similar tools. Herein, we will illustrate current examples, challenges and perspectives in the applications of empirical and mechanistic modeling in the context of childhood metabolic health research. PMID:26301225

  16. Clinical Nursing Research: A Tool for Professional Development ...

    African Journals Online (AJOL)

    These and many more require the best available evidence, which could be acquired through CNR. However to achieve the benefits of CNR for professional development, Challenges including low quality research by new and inexperienced researchers; non-availability of research findings to nurses in the practice sectors; ...

  17. Insights from clinical research completed during the west Africa Ebola virus disease epidemic

    Science.gov (United States)

    Rojek, Amanda; Horby, Peter; Dunning, Jake

    2018-01-01

    The west Africa Ebola virus disease (EVD) epidemic was extraordinary in scale. Now that the epidemic has ended, it is a relevant time to examine published studies with direct relevance to clinical care and, more broadly, to examine the implications of the clinical research response mounted. Clinically relevant research includes literature detailing risk factors for and clinical manifestations of EVD, laboratory and other investigation findings in patients, experimental vaccine and therapeutic clinical trials, and analyses of survivor syndrome. In this Review, we discuss new insights from patient-oriented research completed during the west Africa epidemic, identify ongoing knowledge gaps, and suggest priorities for future research. PMID:28461209

  18. Discover: What Is Public Health?

    Science.gov (United States)

    ... Certified in Public Health ASPPH Public Health Graduate School Viewbook Teach & Research Teach & Research Overview We support education in public health by providing a variety of comprehensive classroom and curriculum resources. Framing The Future Faculty Resources Educational Models ...

  19. Multiple sclerosis in children: an update on clinical diagnosis, therapeutic strategies, and research

    OpenAIRE

    Waldman, Amy; Ghezzi, Angelo; Bar-Or, Amit; Mikaeloff, Yann; Tardieu, Marc; Banwell, Brenda

    2014-01-01

    The clinical features, diagnostic challenges, neuroimaging appearance, therapeutic options, and pathobiological research progress in childhood—and adolescent—onset multiple sclerosis have been informed by many new insights in the past 7 years. National programmes in several countries, collaborative research efforts, and an established international paediatric multiple sclerosis study group have contributed to revised clinical diagnostic definitions, identified clinical features of multiple sc...

  20. Clinical research should be a priority in the NHS - but what do genito-urinary medicine clinic staff think?

    Science.gov (United States)

    Roberts, Rosa; Perry, Nicky; Phillips, Alan; Richardson, Daniel; Soni, Suneeta

    2015-02-01

    Clinical research improves patient care and is a government priority. We sought the opinions of genito-urinary medicine clinic staff regarding undertaking research, any barriers they perceived, and methods to optimise study recruitment. Questionnaires were offered to everyone working in the genito-urinary medicine clinic over a one-week period. In addition, four focus groups were held with genito-urinary medicine clinic staff. Forty-three questionnaires were completed. All respondents stated that research was important; however, 14.0% worried that it affected patient care and 16.3% would rather see patients without having to consider research. Doctors were more likely to enjoy discussing studies than other healthcare staff (p = 0.029) and were less likely to think that too many studies were being conducted at one time (p = 0.027). Forty staff attended the focus groups. Time, knowledge of studies, difficulty in broaching the topic of research and patient factors were cited as barriers to recruitment. Suggestions to improve recruitment included: greater multi-disciplinary team involvement; improving staff research knowledge; streamlining the research process; and patient education. Reasons for different attitudes between staff disciplines towards research included different training pathways and incentives to conduct research. The recommendations staff have made to help drive recruitment should be implemented in the genito-urinary medicine clinic. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  1. Training Needs of Clinical and Research Professionals to Optimize Minority Recruitment and Retention in Cancer Clinical Trials.

    Science.gov (United States)

    Niranjan, Soumya J; Durant, Raegan W; Wenzel, Jennifer A; Cook, Elise D; Fouad, Mona N; Vickers, Selwyn M; Konety, Badrinath R; Rutland, Sarah B; Simoni, Zachary R; Martin, Michelle Y

    2017-08-03

    The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority patient populations. However, clinical trial recruitment is complex and requires a broader appreciation of the multiple factors that influence minority participation. One area that has received little attention is minority recruitment training for professionals who assume various roles in the clinical trial recruitment process. Therefore, we assessed the perspectives of cancer center clinical and research personnel on their training and education needs toward minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five U.S. cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Interviews were recorded and transcribed. Qualitative analyses focused on response data related to training for minority recruitment for cancer clinical trials. Four prominent themes were identified: (1) Research personnel are not currently being trained to focus on recruitment and retention of minority populations; (2) Training for minority recruitment and retention provides for a specific focus on factors influencing minority research participation; (3) Training on cultural awareness may help to bridge cultural gaps between potential minority participants and research professionals; (4) Views differ regarding the importance of research personnel training designed to focus on recruitment of minority populations. There is a lack of systematic training for minority recruitment. Many stakeholders acknowledged the benefits of minority recruitment training and welcomed training that focuses on increasing cultural awareness to increase the participation of minorities in cancer clinical trials.

  2. [Perception and satisfaction of main researchers on the management of a Clinical Research Ethics Committee].

    Science.gov (United States)

    Vilardell Navarro, N; Redondo-Capafons, S; Giménez, N; Quintana, S

    2013-01-01

    To analyze the main researchers (MR) perception and satisfaction associated to face-to-face project presentation as well as Clinical Research Ethics Committee (CREC) functions related to administrative and advisement aspects. Descriptive study performed during nine months (January to September 2011) through voluntary participation questionnaire given to MR who assisted to CREC meetings. The questionnaire contained a numeric range (1-10) and open issues to evaluate the presentation process, the satisfaction of CREC functions considering bureaucratic aspects, ethics, scientific-methodological, legal recommendations and its global function. Descriptive statistics and Student test were performed. The questionnaire was answered by 36 (95%) of total MR. Average score obtained in the evaluation of face-to-face study presentation was 9.2 (SD 0.9). In reference to legal issues an average punctuation of 7.1 (DE 0.4) was obtained, whereas ethics and scientific-methodological aspects scored 8.2 (DE 0.2 and 0.4). Global average evaluation about CREC tasks was 8.6 (SD 1.0). A positive assessment related to attend to the project presentation was made for 22 (61%) of the MR. The study showed a high satisfaction of CREC operation and a high evaluation of face-to-face project presentation. There were detected further improvement aspects to optimize CREC meetings, taking into account the effort developed by MR and CREC members. Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.

  3. Clinical nurses' attitudes towards research, management and organisational resources in a university hospital: part 1.

    Science.gov (United States)

    Akerjordet, Kristin; Lode, Kirsten; Severinsson, Elisabeth

    2012-09-01

    The aim of this study was to determine clinical nurses' interest in and motivation for research. An additional aim was to identify management and organisational resources in order to improve nurses' research capacity in practice. Clinical nurses find conducting research challenging, which accords with observations of the continuing research-practice gap. This descriptive cross-sectional survey sampled 364 clinical nurses from a university hospital on the west coast of Norway. The response rate was 61%. An increasingly positive attitude towards research emerged (40%), despite the fact that few were engaged in research-based activities. Clinical nurses emphasised that lack of designated time (60%), interest (31%) and knowledge (31%) constituted important research barriers, as did lack of research supervision and support (25%). Research supervision was one of the most significant needs to enhance clinical nurses' research skills, management and organisation of research activities (30%). Conscious efforts strategically built on clinical and academic collaborative networks are required to promote and sustain clinical nurses' research capacity. The findings of this survey should be useful in the building of clinical nurses' research capacity. © 2012 Blackwell Publishing Ltd.

  4. Developing independent investigators for clinical research relevant for Africa

    LENUS (Irish Health Repository)

    Manabe, Yukari C

    2011-12-29

    Abstract Sustainable research capacity building requires training individuals at multiple levels within a supportive institutional infrastructure to develop a critical mass of independent researchers. At many African medical institutions, a PhD is important for academic promotion and is, therefore, an important focal area for capacity building programs. We examine the training at the Infectious Diseases Institute (IDI) as a model for in-country training based on systems capacity building and attention to the academic environment. PhD training in Africa should provide a strong research foundation for individuals to perform independent, original research and to mentor others. Training the next generation of researchers within excellent indigenous academic centers of excellence with strong institutional infrastructure will empower trainees to ask regionally relevant research questions that will benefit Africans.

  5. [Which research is needed to support clinical decision-making on integrative medicine? Can comparative effectiveness research close the gap?].

    Science.gov (United States)

    Witt, Claudia M; Huang, Wen-jing; Lao, Lixing; Berman, Brian M

    2013-08-01

    In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of best care options. This evidence, more generalizable than evidence generated by traditional randomized clinical trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on CER is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.

  6. Discovering Pediatric Asthma Phenotypes on the Basis of Response to Controller Medication Using Machine Learning.

    Science.gov (United States)

    Ross, Mindy K; Yoon, Jinsung; van der Schaar, Auke; van der Schaar, Mihaela

    2018-01-01

    Pediatric asthma has variable underlying inflammation and symptom control. Approaches to addressing this heterogeneity, such as clustering methods to find phenotypes and predict outcomes, have been investigated. However, clustering based on the relationship between treatment and clinical outcome has not been performed, and machine learning approaches for long-term outcome prediction in pediatric asthma have not been studied in depth. Our objectives were to use our novel machine learning algorithm, predictor pursuit (PP), to discover pediatric asthma phenotypes on the basis of asthma control in response to controller medications, to predict longitudinal asthma control among children with asthma, and to identify features associated with asthma control within each discovered pediatric phenotype. We applied PP to the Childhood Asthma Management Program study data (n = 1,019) to discover phenotypes on the basis of asthma control between assigned controller therapy groups (budesonide vs. nedocromil). We confirmed PP's ability to discover phenotypes using the Asthma Clinical Research Network/Childhood Asthma Research and Education network data. We next predicted children's asthma control over time and compared PP's performance with that of traditional prediction methods. Last, we identified clinical features most correlated with asthma control in the discovered phenotypes. Four phenotypes were discovered in both datasets: allergic not obese (A + /O - ), obese not allergic (A - /O + ), allergic and obese (A + /O + ), and not allergic not obese (A - /O - ). Of the children with well-controlled asthma in the Childhood Asthma Management Program dataset, we found more nonobese children treated with budesonide than with nedocromil (P = 0.015) and more obese children treated with nedocromil than with budesonide (P = 0.008). Within the obese group, more A + /O + children's asthma was well controlled with nedocromil than with budesonide (P = 0.022) or with placebo

  7. Testing a model of research intention among U.K. clinical psychologists: a logistic regression analysis.

    Science.gov (United States)

    Eke, Gemma; Holttum, Sue; Hayward, Mark

    2012-03-01

    Previous research highlights barriers to clinical psychologists conducting research, but has rarely examined U.K. clinical psychologists. The study investigated U.K. clinical psychologists' self-reported research output and tested part of a theoretical model of factors influencing their intention to conduct research. Questionnaires were mailed to 1,300 U.K. clinical psychologists. Three hundred and seventy-four questionnaires were returned (29% response-rate). This study replicated in a U.K. sample the finding that the modal number of publications was zero, highlighted in a number of U.K. and U.S. studies. Research intention was bimodally distributed, and logistic regression classified 78% of cases successfully. Outcome expectations, perceived behavioral control and normative beliefs mediated between research training environment and intention. Further research should explore how research is negotiated in clinical roles, and this issue should be incorporated into prequalification training. © 2012 Wiley Periodicals, Inc.

  8. Newly discovered insect RNA viruses in China.

    Science.gov (United States)

    Qiu, Yang; Wang, ZhaoWei; Liu, YongXiang; Qi, Nan; Si, Jie; Xiang, Xue; Xia, XiaoLing; Hu, YuanYang; Zhou, Xi

    2013-08-01

    Insects are a group of arthropods and the largest group of animals on Earth, with over one million species described to date. Like other life forms, insects suffer from viruses that cause disease and death. Viruses that are pathogenic to beneficial insects cause dramatic economic losses on agriculture. In contrast, viruses that are pathogenic to insect pests can be exploited as attractive biological control agents. All of these factors have led to an explosion in the amount of research into insect viruses in recent years, generating impressive quantities of information on the molecular and cellular biology of these viruses. Due to the wide variety of insect viruses, a better understanding of these viruses will expand our overall knowledge of their virology. Here, we review studies of several newly discovered RNA insect viruses in China.

  9. The Meta-Analysis of Clinical Judgment Project: Fifty-Six Years of Accumulated Research on Clinical Versus Statistical Prediction

    Science.gov (United States)

    Aegisdottir, Stefania; White, Michael J.; Spengler, Paul M.; Maugherman, Alan S.; Anderson, Linda A.; Cook, Robert S.; Nichols, Cassandra N.; Lampropoulos, Georgios K.; Walker, Blain S.; Cohen, Genna; Rush, Jeffrey D.

    2006-01-01

    Clinical predictions made by mental health practitioners are compared with those using statistical approaches. Sixty-seven studies were identified from a comprehensive search of 56 years of research; 92 effect sizes were derived from these studies. The overall effect of clinical versus statistical prediction showed a somewhat greater accuracy for…

  10. How clinical trials really work rethinking research ethics.

    Science.gov (United States)

    DeBruin, Debra A; Liaschenko, Joan; Fisher, Anastasia

    2011-06-01

    Despite prevalent concerns about the ethical conduct of clinical trials, little is known about the day-to-day work of trials and the ethical challenges arising in them. This paper reports on a study designed to fill this gap and demonstrates a need to refine the oversight system for trials to reflect an understanding of this day-to-day work. It also illuminates ethical challenges that cannot be addressed by the oversight system and so necessitate a rethinking of the ethics of clinical trials.

  11. Clinical Research: A Psychotherapeutic Assessment Model for Siblings in Care

    Science.gov (United States)

    Hindle, Debbie

    2007-01-01

    This paper focuses on the aspects of a qualitative research project that examines an assessment protocol for the placement of siblings in foster care and/or future adoption. A brief description of the background to the study and the research design is given. Evaluating the material from the quantitative instruments used and the psychotherapeutic…

  12. Establishing community advisory boards for clinical trial research in ...

    African Journals Online (AJOL)

    In this article I deal with extending the ethical principles of research to include communities through the establishment of Community Advisory Boards (CABs). The aim of the project on which this article is based demonstrates the need for protecting communities that participate in research in order to stimulate ethical conduct ...

  13. 'Nursing research culture' in the context of clinical nursing practice

    DEFF Research Database (Denmark)

    Bøttcher Berthelsen, Connie; Hølge-Hazelton, Bibi

    2017-01-01

    for efficiency, nurses’ barriers to research use and the lack of definition of the concept of nursing research culture make it difficult to establish. Design Concept analysis. Data sources Data were collected through a literature review in PubMed, CINAHL and PsycINFO during March 2016. Methods Walker and Avant...

  14. Clinical Research Trials and You: Questions and Answers

    Science.gov (United States)

    ... place today were primarily a response to past research abuses. Informed Consent Informed consent is the process of learning the ... team explain the details of the study. The research team provides an informed consent document, which includes such details about the study, ...

  15. Handbook of Attachment: Theory, Research, and Clinical Applications.

    Science.gov (United States)

    Cassidy, Jude, Ed.; Shaver, Phillip R., Ed.

    The theoretical work on attachment behavior by John Bowlby and Mary Ainsworth spawned one of the broadest, most creative lines of research in twentieth century psychology. This volume compiles articles discussing attachment theory and research, measurement issues, and contributions of recent theoretical and empirical developments to the study of…

  16. Evaluating clinical research: all that glitters is not gold

    National Research Council Canada - National Science Library

    Furberg, Curt; Furberg, Bengt

    2007-01-01

    ...? Why is blinding/masking so important? How is symptomatic improvement measured? Is it really possible to assess quality of life? What is the value of biologic markers in drug evaluation? How are adverse drug reactions measured? How representative are study subjects in clinical trials? What happened to the study subjects who disappeared from the...

  17. [Clinical research on repairing alveolar cleft with osteoinduction active material].

    Science.gov (United States)

    She, Xiao-ming; Zhang, Qian; Tian, Kun; Yang, Li; Xiong, Gui-fa

    2010-08-01

    To study the feasibility and authenticity of repairing alveolar defects in alveolar cleft patients with osteoinduction active material (OAM) in clinic. Twenty-seven cases of alveolar defect chosen from clinic were divided into two groups (test group and control group). For test group (12 cases), OAM was transplanted to repair the alveolar cleft. For control group (15 cases), autogenous ilium cancellous bone were transplanted into the defect region to repair alveolar cleft. At 6 months after operation, CT and three-dimensional reconstruction were used to observe alveolar appearance, and the effect and clinical success rate of recover alveolar cleft by using different repair material were compared. In the 27 cases, all the maxillary continuity was restored except two of test group and two of control group. There was no significant difference between test group and control group regarding the clinical success rate of the alveolar cleft repair (P = 1.000). OAM was used to repair the alveolar cleft that can result in new bone formations and the burgeon of canines from the bone grafted areas. There is no significant difference between OAM and autogenous ilium cancellous bone regarding the effect of the alveolar cleft repair.

  18. Implementation of statistical analysis in the clinical research of ...

    African Journals Online (AJOL)

    Background: Coeliac disease (CD) is an autoimmune disorder of the small intestine that occurs in genetically predisposed people of all ages. The objective of this study is to investigate the relation between demographic and clinical factors with coeliac disease using probit and logit models. Methods: During the period of ...

  19. Trends in clinical reproductive medicine research : 10 years of growth

    NARCIS (Netherlands)

    Aleixandre-Benavent, Rafael; Simon, Carlos; Fauser, Bart C J M|info:eu-repo/dai/nl/071281932

    2015-01-01

    Objective To study the most important metrics of publication in the field of reproductive medicine over the decade 2003-2012 to aid in discerning the clinical, social, and epidemiologic implications of this relatively new but rapidly emerging area in medical sciences. Design Bibliometric analysis of

  20. Repeated Measures Analysis of Means in Clinical Research.

    Science.gov (United States)

    Jaccard, James; Ackerman, Lee

    1985-01-01

    Notes assumptions for analyzing treatment means in repeated measures designs. The traditional F test has been shown to have limitations, given violations of the assumption of sphericity. This assumption is probably infrequently satisfied in clinical applications. Discusses analytic alternatives based on a three-step Geisser-Greenhouse approach.…

  1. Research Methods for Assessing and Evaluating School-Based Clinics.

    Science.gov (United States)

    Kirby, Douglas

    This monograph describes three types of evaluation that are potentially useful to school-based clinics: needs assessments, process evaluations, and impact evaluations. Two important methodological principles are involved: (1) collecting multiple kinds of data with multiple methods; and (2) collecting comparison data. Student needs can be…

  2. Roles of Clinical Research Networks in Pediatric Drug Development

    NARCIS (Netherlands)

    Turner, M.A.; Attar, S.; Wildt, S.N. de; Vassal, G.; Mangiarini, L.; Giaquinto, C.

    2017-01-01

    The evaluation of drugs that are used in children has been neglected historically but is now well established as an essential part of clinical drug development. The increase in pediatric activity among industry, and other sectors, has highlighted the importance of joint working. All participants in

  3. RESEARCH NOTE Clinical Utility of a 377 gene custom NGS ...

    Indian Academy of Sciences (India)

    2016-11-11

    Nov 11, 2016 ... reduces the ambiguity of reporting VUSs, particularly in light of the non-seizure related association of ~70% of the genes. Furthermore, our data suggests that rarer genes may play a more significant role in the manifestation of epileptic phenotypes. The clinical utility of a test is primarily determined by its ...

  4. Research and clinical aspects of the late effects of poliomyelitis

    Energy Technology Data Exchange (ETDEWEB)

    Halstead, L.S.; Wiechers, D.O.

    1986-01-01

    This book contains 32 selections. Some of the titles are: Late effects of Polio: Historical Perspectives; Sleep-Disordered Breathing as a Late Effect of Poliomyelitis; Clinical Subtypes, DNA Repair Efficiency, and Therapeutic Trials in the Post-Polio Syndromes; and Post-Polio Muscle Function.

  5. What makes a high quality clinical research paper?

    Science.gov (United States)

    Groves, T

    2010-05-01

    The quality of a research paper depends primarily on the quality of the research study it reports. However, there is also much that authors can do to maximise the clarity and usefulness of their papers. Journals' instructions for authors often focus on the format, style, and length of articles but do not always emphasise the need to clearly explain the work's science and ethics: so this review reminds researchers that transparency is important too. The research question should be stated clearly, along with an explanation of where it came from and why it is important. The study methods must be reported fully and, where appropriate, in line with an evidence based reporting guideline such as the CONSORT statement for randomised controlled trials. If the study was a trial the paper should state where and when the study was registered and state its registration identifier. Finally, any relevant conflicts of interest should be declared.

  6. CPTAC Teams | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The following are the current CPTAC teams, representing a network of Proteome Characterization Centers (PCCs), Proteogenomic Translational Research Centers (PTRCs), and Proteogenomic Data Analysis Centers (PGDACs). Teams are listed alphabetically by institution, with their respective Principal Investigators:

  7. Call for Applications – Clinical Assay Development Program | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The NCI Clinical Assay Development Program (CADP) is requesting project applications from investigators seeking clinical assay validation resources.  These resources are designed to assist with the development of assays that may predict therapy response or prognostic behavior of a diagnosed cancer, primarily for use in clinical trials. Approved projects for the NCI CADP will be provided access to the Institute’s assay development and validation resources, including project management support.

  8. [Quality criteria of thoracic radiotherapy. Application to clinical research].

    Science.gov (United States)

    Girard, N; Mornex, F

    2007-10-01

    Lung cancer is a suitable model for studying the quality criteria of radiotherapy, as irradiation of the intra-thoracic organs is complex. The recent availability of conformational techniques allows the analysis of these difficulties, as treated volumes are adapted to the target volume in a three-dimensional setting. Radiotherapy has then become a major therapeutic option of the treatment of non-small cell lung cancer. Radiation protection and technical quality criteria for radiotherapy have been integrated for a long time into the global control programs for civil use of ionizing radiation. Clinical quality criteria were defined more recently both from radio-biological data available in the literature and by the analysis of historical radiation accidents and risk management. Good clinical practice in radiotherapy is part of the global quality requirements for cancer treatment, and remains the key to maintaining quality in an increasingly technological area of medicine.

  9. Terminology development towards harmonizing multiple clinical neuroimaging research repositories.

    Science.gov (United States)

    Turner, Jessica A; Pasquerello, Danielle; Turner, Matthew D; Keator, David B; Alpert, Kathryn; King, Margaret; Landis, Drew; Calhoun, Vince D; Potkin, Steven G; Tallis, Marcelo; Ambite, Jose Luis; Wang, Lei

    2015-07-01

    Data sharing and mediation across disparate neuroimaging repositories requires extensive effort to ensure that the different domains of data types are referred to by commonly agreed upon terms. Within the SchizConnect project, which enables querying across decentralized databases of neuroimaging, clinical, and cognitive data from various studies of schizophrenia, we developed a model for each data domain, identified common usable terms that could be agreed upon across the repositories, and linked them to standard ontological terms where possible. We had the goal of facilitating both the current user experience in querying and future automated computations and reasoning regarding the data. We found that existing terminologies are incomplete for these purposes, even with the history of neuroimaging data sharing in the field; and we provide a model for efforts focused on querying multiple clinical neuroimaging repositories.

  10. Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

    Science.gov (United States)

    von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H; Pauli-Magnus, Christiane; Briel, Matthias

    2017-01-01

    To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders

  11. Original Research Clinical characteristics and outcomes of patients ...

    African Journals Online (AJOL)

    A total of 450 stroke cases, (63% women) were included in the final analysis. The proportion of stroke cases among the admissions was. 0.61%. Mean age of the stroke patients was 61.6±16.8 years (95% CI=60.1; 63.2). Risk factors were hypertension (58.5%), diabetes (18%) and HIV, (14%)). Diagnosis was clinical and ...

  12. ClinData Express--a metadata driven clinical research data management system for secondary use of clinical data.

    Science.gov (United States)

    Li, Zuofeng; Wen, Jingran; Zhang, Xiaoyan; Wu, Chunxiao; Li, Zuogao; Liu, Lei

    2012-01-01

    Aim to ease the secondary use of clinical data in clinical research, we introduce a metadata driven web-based clinical data management system named ClinData Express. ClinData Express is made up of two parts: 1) m-designer, a standalone software for metadata definition; 2) a web based data warehouse system for data management. With ClinData Express, what the researchers need to do is to define the metadata and data model in the m-designer. The web interface for data collection and specific database for data storage will be automatically generated. The standards used in the system and the data export modular make sure of the data reuse. The system has been tested on seven disease-data collection in Chinese and one form from dbGap. The flexibility of system makes its great potential usage in clinical research. The system is available at http://code.google.com/p/clindataexpress.

  13. Applications of mixed-methods methodology in clinical pharmacy research.

    Science.gov (United States)

    Hadi, Muhammad Abdul; Closs, S José

    2016-06-01

    Introduction Mixed-methods methodology, as the name suggests refers to mixing of elements of both qualitative and quantitative methodologies in a single study. In the past decade, mixed-methods methodology has gained popularity among healthcare researchers as it promises to bring together the strengths of both qualitative and quantitative approaches. Methodology A number of mixed-methods designs are available in the literature and the four most commonly used designs in healthcare research are: the convergent parallel design, the embedded design, the exploratory design, and the explanatory design. Each has its own unique advantages, challenges and procedures and selection of a particular design should be guided by the research question. Guidance on designing, conducting and reporting mixed-methods research is available in the literature, so it is advisable to adhere to this to ensure methodological rigour. When to use it is best suited when the research questions require: triangulating findings from different methodologies to explain a single phenomenon; clarifying the results of one method using another method; informing the design of one method based on the findings of another method, development of a scale/questionnaire and answering different research questions within a single study. Two case studies have been presented to illustrate possible applications of mixed-methods methodology. Limitations Possessing the necessary knowledge and skills to undertake qualitative and quantitative data collection, analysis, interpretation and integration remains the biggest challenge for researchers conducting mixed-methods studies. Sequential study designs are often time consuming, being in two (or more) phases whereas concurrent study designs may require more than one data collector to collect both qualitative and quantitative data at the same time.

  14. A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness. Commentary.

    Science.gov (United States)

    Amato, Antonino; Aringhieri, Eugenio; Boccia, Stefania; Buccella, Filippo; Gorini, Barbara; Gramaglia, Donatella; Masetti, Riccardo; Rossi, Paolo; Pelicci, Pier Giuseppe

    2017-01-01

    The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best conditions for the implementation of the new Regulation through national guidelines, so that sponsors may reconsider Europe as a prime location for planning clinical trials. During a meeting titled "Innovation in Clinical Research", an expert panel discussed potential local advances fostering competitiveness of European clinical research with representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency in view of the forthcoming implementation of (EU) No. 536/2014 on clinical trials of medicinal products. In this article we summarise the findings of the meeting, describe features characterising clinical research patterns and offer some suggestions on the possible involvement of all stakeholders in order to foster research innovation and allow the timely access to novel medicines for patients.

  15. Religion, Spirituality, and Health: The Research and Clinical Implications

    Science.gov (United States)

    Koenig, Harold G.

    2012-01-01

    This paper provides a concise but comprehensive review of research on religion/spirituality (R/S) and both mental health and physical health. It is based on a systematic review of original data-based quantitative research published in peer-reviewed journals between 1872 and 2010, including a few seminal articles published since 2010. First, I provide a brief historical background to set the stage. Then I review research on R/S and mental health, examining relationships with both positive and negative mental health outcomes, where positive outcomes include well-being, happiness, hope, optimism, and gratefulness, and negative outcomes involve depression, suicide, anxiety, psychosis, substance abuse, delinquency/crime, marital instability, and personality traits (positive and negative). I then explain how and why R/S might influence mental health. Next, I review research on R/S and health behaviors such as physical activity, cigarette smoking, diet, and sexual practices, followed by a review of relationships between R/S and heart disease, hypertension, cerebrovascular disease, Alzheimer's disease and dementia, immune functions, endocrine functions, cancer, overall mortality, physical disability, pain, and somatic symptoms. I then present a theoretical model explaining how R/S might influence physical health. Finally, I discuss what health professionals should do in light of these research findings and make recommendations in this regard. PMID:23762764

  16. Collaborative partnership and the social value of clinical research: a qualitative secondary analysis.

    Science.gov (United States)

    Nurmi, Sanna-Maria; Halkoaho, Arja; Kangasniemi, Mari; Pietilä, Anna-Maija

    2017-10-25

    Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research. A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders' perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al. The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for

  17. [New Royal Decree on clinical trials: main implications for emergency medicine physicians who do research].

    Science.gov (United States)

    García Arenillas, Mar; Haj-Ali Saflo, Okba; Sáenz de Tejada, Marta

    2017-06-01

    The new European Union directives affecting clinical trials of medicines introduced important changes for Spain, leading to the publication of a Royal Decree regulating the conduct of clinical trials that went into effect in January 2016. The decree sets out the principles for complying with the EU directives, regulates the work of institutional review boards (IRBs) or ethics committees that review research proposals, introduces means to facilitate clinical research, and clarifies the role of the Spanish register of clinical trials, among other topics. This paper discusses the main changes that have been introduced, especially those intended to facilitate research, such as the new concepts of low intervention trial and noncommercial clinical research. These concepts may be particularly useful for clinical trials designed by emergency medicine physicians. We also comment on changes affecting vulnerable populations and the documents that must be presented to both the researchers' IRB and the Spanish Agency for Medicines and Health Care Products.

  18. Non clinical research at CENTIS supporting biotechnological and pharmaceutical industry

    International Nuclear Information System (INIS)

    Hernandez Gonzalez, Ignacio

    2012-01-01

    Drugs production is a highly demanding industry because the rigor of legislations and guidelines. Standards are applied to manufacturing facilities and also to research and development stage. Our national biotechnological industry is developing and producing important medications for diseases like cancer, some of them in the national and international market. Isotopes Centre is an institution supporting such development by means of a work platform to carry out researches in the field of pharmacokinetic and biodistribution in experimental models. Accumulated experience allows us to contribute to research and development of different kind of molecules as pharmaceuticals, specially the biotechnological ones. We are evolving in direction to new technologies and methodologies more suitable to current standards. Radiolabeling is still a convenient choice considering present and new imaging technologies to investigate distribution and kinetic in living subjects. With the techniques we have and the ones to incorporate in a near future, new and more demanding investigations will be affordable. (author)

  19. 76 FR 19189 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2011-04-06

    ... Research and Development Service Cooperative Studies Scientific Evaluation Committee will be held on April... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation Committee; Notice of Meeting The Department of Veterans Affairs (VA) gives...

  20. 76 FR 65781 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2011-10-24

    ... Research and Development Service Cooperative Studies Scientific Evaluation Committee will be held on... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation Committee, Notice of Meeting The Department of Veterans Affairs (VA) gives...

  1. 75 FR 79446 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2010-12-20

    ... Research and Development Service Cooperative Studies Scientific Evaluation Committee will be held on... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation Committee; Notice of Meeting The Department of Veterans Affairs (VA) gives...

  2. 76 FR 73781 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2011-11-29

    ... Research and Development Service Cooperative Studies Scientific Evaluation Committee will be held on... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation Committee; Notice of Meeting The Department of Veterans Affairs (VA) gives...

  3. 75 FR 28686 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2010-05-21

    ... Research and Development Service Cooperative Studies Scientific Evaluation Committee will be held on June... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation Committee; Notice of Meeting The Department of Veterans Affairs (VA) gives...

  4. 77 FR 31072 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2012-05-24

    ... Research and Development Service Cooperative Studies Scientific Evaluation Committee will be held on July... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation Committee; Notice of Meeting The Department of Veterans Affairs (VA) gives...

  5. [Organization of clinical research: in a large scale department for cardiothoracic surgery].

    Science.gov (United States)

    Sarikouch, S; Schilling, T; Haverich, A

    2010-04-01

    Translation of basic research results into routine patient care is delayed in parts by lack of institutionalization in clinical research. In this article the research structure and organization of our Department of Cardiac, Thoracic, Transplantation and Vascular Surgery are described.Basic research, separately directed, is accomplished in the Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO) and within the scope of the Excellence cluster "REBIRTH--from Regenerative Biology to Reconstructive Therapy".Clinical research is directed by heads of the subdepartments of our institution (valve and coronary surgery, aortic surgery, surgical electrophysiology, vascular surgery, thoracic surgery, cardiac assist systems, thoracic transplantation, intensive care and pediatric heart surgery).A separate subdepartment for clinical research is responsible for study coordination and accompanies clinical studies from study design and patient screening to publication. This subdepartment also serves as a constant contact to sponsors and superordinated research organizations within the Hannover Medical School.

  6. Which research is needed to support clinical decision-making on integrative medicine?- Can comparative effectiveness research close the gap?

    Science.gov (United States)

    Witt, Claudia M; Huang, Wen-jing; Lao, Lixing; Bm, Berman

    2012-10-01

    In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of the best care options. This evidence, more generalizable than the evidence generated by traditional randomized controlled trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on comparative effectiveness is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.

  7. Preparing clinical pharmacy scientists for careers in clinical/translational research: can we meet the challenge?: ACCP Research Affairs Committee Commentary.

    Science.gov (United States)

    Parker, Robert B; Ellingrod, Vicki; DiPiro, Joseph T; Bauman, Jerry L; Blouin, Robert A; Welage, Lynda S

    2013-12-01

    Developing clinical pharmacists' research skills and their ability to compete for extramural funding is an important component of the American College of Clinical Pharmacy's (ACCP) vision for pharmacists to play a prominent role in generating the new knowledge used to guide patient pharmacotherapy. Given the recent emphasis on clinical/translational research at the National Institutes of Health (NIH) and the key role of drug therapy in the management of many diseases, there is an unprecedented opportunity for the profession to contribute to this enterprise. A crucial question facing the profession is whether we can generate enough appropriately trained scientists to take advantage of these opportunities to generate the new knowledge to advance drug therapy. Since the 2009 publication of the ACCP Research Affairs Committee editorial recommending the Ph.D. degree (as opposed to fellowship training) as the optimal method for preparing pharmacists as clinical/translational scientists, significant changes have occurred in the economic, professional, political, and research environments. As a result, the 2012 ACCP Research Affairs Committee was charged with reexamining the college's position on training clinical pharmacy scientists in the context of these substantial environmental changes. In this commentary, the potential impact of these changes on opportunities for pharmacists in clinical/translational research are discussed as are strategies for ACCP, colleges of pharmacy, and the profession to increase the number and impact of clinical pharmacy scientists. Failure of our profession to take advantage of these opportunities risks our ability to contribute substantively to the biomedical research enterprise and ultimately improve the pharmacotherapy of our patients. © 2013 Pharmacotherapy Publications, Inc.

  8. A Comprehensive Epidemiological Research for Clinical Vibrio parahaemolyticus in Shanghai

    Directory of Open Access Journals (Sweden)

    Huan Li

    2017-06-01

    Full Text Available Vibrio parahaemolyticus is one of the most important pathogen for seafood-borne gastroenteritis in Shanghai and the rest of the world. A total of 42 V. parahaemolyticus strains were isolated from 1900 fecal specimens collected from patients in Shanghai hospital presenting from January 2014 to December 2015. All isolates were evaluated for potential virulence factors [tdh, trh, and type three secretion system (T3SS genes], typed using multilocus sequence typing (MLST and screened for antimicrobial resistance phenotype and genotype. And for the first time, the relationship between virulence, genetic diversity and antimicrobial resistance of these isolates were identified. The results showed that 37 isolates carried the tdh gene (88.1% and only seven isolates were positive for the trh gene. The T3SS1 and T3SS2 genes were detected in all strains and only trh-positive isolates are also containing the T3SS2β genes. MLST analysis of the 42 Shanghai isolates identified 20 sequence types (STs with 16 novel STs and that these clinical V. parahaemolyticus strains showed high degrees of genetic diversity. All isolates expressed high levels of resistance against Ampicillin (100.0%, Streptomycin (100.0%, Cephazolin (92.9%, Kanamycin (92.8% and Amikacin (90.5%, and eight out of 38 resistance genes (SHV, tet(B, strA, qnrA, gryA, qnrB, sulI, sulII were detected in at least two isolates. This study confirms that antimicrobial resistance of clinical V. parahaemolyticus isolates is greater than those of environmental isolates. Furthermore, no clear correlation between antimicrobial resistance and virulence or genetic diversity was found in this study. These results add to epidemiological data of clinical V. parahaemolyticus isolates in Shanghai and highlight the need for additional mechanistic studies, especially antimicrobial resistance, to reduce the burden of disease caused by this pathogen in China.

  9. Discovering a dialectic of care.

    Science.gov (United States)

    Mohr, W K

    1999-04-01

    Using data from a recent study on the outcomes of child psychiatric hospitalization, the author presents a critique of the intervention-outcome movement that dominates the health care agenda. Employing an exploratory descriptive study design and Denzin's interpretive interactionism method, she presents data that illustrate how interventions can become distorted by contextual factors, conflicting ideologies, agendas, and failure to thoughtfully consider patient needs. She posits that research agendas are heavily tilted toward outcomes research that often discount the nature of structure and process. The marketplace emphasis of health care may result in environments in which a structure and process of caring is replaced by a focus of profits over patients. The value of focusing on interventions and outcomes in research without addressing broader ecosystem variables that influence practice is questioned in view of in-depth data that emerge from practice settings.

  10. Building the Clinical Bridge to Advance Education, Research, and Practice Excellence

    Directory of Open Access Journals (Sweden)

    Marilyn Svejda

    2012-01-01

    Full Text Available The University of Michigan School of Nursing and the Health System partnered to develop an undergraduate clinical education model as part of a larger project to advance clinical education, practice, and scholarship with education serving as the clinical bridge that anchors all three areas. The clinical model includes clusters of clinical units as the clinical home for four years of a student's education, clinical instruction through team mentorship, clinical immersion, special skills preparation, and student portfolio. The model was examined during a one-year pilot with junior students. Stakeholders were largely positive. Findings showed that Clinical Faculty engaged in more role modeling of teaching strategies as Mentors assumed more direct teaching used more clinical reasoning strategies. Students reported increased confidence and competence in clinical care by being integrated into the team and the Mentor's assignment. Two new full time faculty roles in the Health System support education, practice, and research.

  11. Establishing community advisory boards for clinical trial research in ...

    African Journals Online (AJOL)

    composition of CABs, leadership qualities, among others. This course places emphasis in areas that ICHGCP ... interests of the community function as a source of leadership in the partnerships between researchers and the .... This implied that the idea of volunteering or volunteer work during CAB training was not properly ...

  12. The pig as an experimental model for clinical craniofacial research

    Czech Academy of Sciences Publication Activity Database

    Štembírek, Jan; Kyllar, M.; Putnová, I.; Stehlík, L.; Buchtová, Marcela

    2012-01-01

    Roč. 46, č. 4 (2012), s. 269-279 ISSN 0023-6772 R&D Projects: GA ČR(CZ) GP304/08/P289 Institutional research plan: CEZ:AV0Z50450515 Keywords : platelet rich plasma * streptococcus suis serotype 2 * implant surface coatings Subject RIV: EG - Zoology Impact factor: 1.257, year: 2012

  13. Software Tools | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The CPTAC program develops new approaches to elucidate aspects of the molecular complexity of cancer made from large-scale proteogenomic datasets, and advance them toward precision medicine.  Part of the CPTAC mission is to make data and tools available and accessible to the greater research community to accelerate the discovery process.

  14. Writing Clinical Research Papers for Publication | Arotiba | Nigerian ...

    African Journals Online (AJOL)

    Potential minefields of academic research and writing such as authorship, plagiarism, duplicate publication and 'salami-slicing' were highlighted. Recommendation: Education in the 'art' of writing and presentation of scientific papers and the critical appraisal of scientific literature need to be included in our undergraduate ...

  15. Nurse leaders' perceptions of the ethical recruitment of study subjects in clinical research.

    Science.gov (United States)

    Nurmi, Sanna-Maria; Pietilä, Anna-Maija; Kangasniemi, Mari; Halkoaho, Arja

    2015-11-01

    The aim of this study was to describe nurse leaders' perceptions of ethical recruitment in clinical research. Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues. Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis. Nurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture. Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained. The duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff. © 2014 John Wiley & Sons Ltd.

  16. Multidimensional Dyspnea Profile: an instrument for clinical and laboratory research.

    Science.gov (United States)

    Banzett, Robert B; O'Donnell, Carl R; Guilfoyle, Tegan E; Parshall, Mark B; Schwartzstein, Richard M; Meek, Paula M; Gracely, Richard H; Lansing, Robert W

    2015-06-01

    There is growing awareness that dyspnoea, like pain, is a multidimensional experience, but measurement instruments have not kept pace. The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses in laboratory and clinical settings. Here we provide the MDP, review published evidence regarding its measurement properties and discuss its use and interpretation. The MDP assesses dyspnoea during a specific time or a particular activity (focus period) and is designed to examine individual items that are theoretically aligned with separate mechanisms. In contrast, other multidimensional dyspnoea scales assess recalled recent dyspnoea over a period of days using aggregate scores. Previous psychophysical and psychometric studies using the MDP show that: 1) subjects exposed to different laboratory stimuli could discriminate between air hunger and work/effort sensation, and found air hunger more unpleasant; 2) the MDP immediate unpleasantness scale (A1) was convergent with common dyspnoea scales; 3) in emergency department patients, two domains were distinguished (immediate perception, emotional response); 4) test-retest reliability over hours was high; 5) the instrument responded to opioid treatment of experimental dyspnoea and to clinical improvement; 6) convergent validity with common instruments was good; and 7) items responded differently from one another as predicted for multiple dimensions. Copyright ©ERS 2015.

  17. Clinical research of bone scan characteristics for metabolic bone diseases

    International Nuclear Information System (INIS)

    Zhu Ruisen; Luo Qiong; Lu Haikui; Chen Libo; Luo Quanyong

    2009-01-01

    Characteristic images of 99m Tc-MDP bone scintigraphy in patients with metabolic bone diseases (MBD) were analyzed and compared, in an attempt to improve the capability of differential diagnosis in this aspect. A total of 142 cases, clinically confirmed as (MBD), were categorized into six groups: hyperparathyroidism (117), renal osteodystrophy (4), Paget's disease (16), hypophosphatemic osteomalacia (2), Albers-Schonberg disease (2), and Brittle bone disease (1). They were diagnosed clinically or pathologically, and scanned with 99m Tc-MDP bone scintegraphy, from which the 142 MBD cases were classified into 4 types. The cases of Type I had increased amount of 99m Tc-MDP uptake in whole body bones, including hyperparathyroidism, Albers-Schonberg disease, brittle bone disease and renal osteodystrophy. The cases of Type II had high uptake of 99m Tc-MDP in local region of bones, including paget's disease, hypophosphatemic osteomalacia and hyperparathyroidism. A Type I case with pathological fracture or secondary osteopathy was classified as Type III. Type IV cases were in early stage of hyperparathyroidism, with normal bone scan image. Analysis of the characteristics of 99m Tc-MDP bone scintigraphic findings (locations, morphology and intensities) in patients with MBD may be helpful in the differential diagnosis of MBD, in association with the patient's history and X-ray data altogether. (authors)

  18. Collaborative translational research leading to multicenter clinical trials in Duchenne muscular dystrophy: the Cooperative International Neuromuscular Research Group (CINRG).

    Science.gov (United States)

    Escolar, Diana M; Henricson, Erik K; Pasquali, Livia; Gorni, Ksenija; Hoffman, Eric P

    2002-10-01

    Progress in the development of rationally based therapies for Duchenne muscular dystrophy has been accelerated by encouraging multidisciplinary, multi-institutional collaboration between basic science and clinical investigators in the Cooperative International Research Group. We combined existing research efforts in pathophysiology by a gene expression profiling laboratory with the efforts of animal facilities capable of conducting high-throughput drug screening and toxicity testing to identify safe and effective drug compounds that target different parts of the pathophysiologic cascade in a genome-wide drug discovery approach. Simultaneously, we developed a clinical trial coordinating center and an international network of collaborating physicians and clinics where those drugs could be tested in large-scale clinical trials. We hope that by bringing together investigators at these facilities and providing the infrastructure to support their research, we can rapidly move new bench discoveries through animal model screening and into therapeutic testing in humans in a safe, timely and cost-effective setting.

  19. Five-year review of an international clinical research-training program.

    Science.gov (United States)

    Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; Dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben Mw; Fregni, Felipe

    2015-01-01

    The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008-2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background.

  20. Citrus bergamia essential oil: from basic research to clinical application

    Directory of Open Access Journals (Sweden)

    Michele eNavarra

    2015-03-01

    Full Text Available Citrus bergamia Risso et Poiteau, also known as Bergamot, is a plant belonging to the Rutaceae family, defined as a hybrid of bitter orange and lemon. It is an endemic plant of the Calabria region (Italy. Bergamot fruit is primarily used for the extraction of its essential oil (bergamot essential oil: BEO, employed in perfume, cosmetics, food and confections.The aim of this review was to collect recent data from the literature on Citrus bergamia essential oil and, through a critical analysis, focus on safety and the beneficial effects on human health. Clinical studies on the therapeutic applications of BEO exclusively focus on the field of aromatherapy, suggesting that its use can be useful for reducing anxiety and stress.

  1. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Science.gov (United States)

    2013-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice AGENCY: Food and Drug...

  2. Implementing a research governance framework for clinical and public health research.

    Science.gov (United States)

    Poustie, Stephanie J; Taylor, David McD; Forbes, Andrew B; Skiba, Marina A; Nelson, Mark R; McNeil, John J

    Research conduct in Australia and worldwide is mostly unaudited. The purpose of good research governance is to ensure integrity in research through accountability, transparency and responsibility. Institutional responsibility for research governance has been adopted by Monash University's Department of Epidemiology and Preventive Medicine, providing clear lines of accountability for researchers as well as support and guidance. A research audit tool has been developed, identifying areas where practice could be improved especially among less experienced researchers; the most common adverse findings concerned research protocols and procedure manuals. The need for participant confidentiality, privacy and data security was found to be understood, and adhered to widely by all researchers. An evaluation of the effect of audit on researchers found that the process was well accepted.

  3. 78 FR 41198 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2013-07-09

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation Committee, Notice of Meeting The Department of Veterans Affairs gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and...

  4. 78 FR 53015 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2013-08-27

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation Committee, Notice of Meeting The Department of Veterans Affairs gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and...

  5. 77 FR 72438 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2012-12-05

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation Committee; Notice of Meeting The Department of Veterans Affairs gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and...

  6. 78 FR 70102 - Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation...

    Science.gov (United States)

    2013-11-22

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation Committee; Notice of Meeting The Department of Veterans Affairs gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and...

  7. Clinical and Research Perspectives on Nonspeech Oral Motor Treatments and Evidence-Based Practice

    Science.gov (United States)

    Muttiah, Nimisha; Georges, Katie; Brackenbury, Tim

    2011-01-01

    Purpose: Evidence-based practice (EBP) involves the incorporation of research evidence, clinical expertise, and client values in clinical decision making. One case in which these factors conflict is the use of nonspeech oral motor treatments (NSOMTs) for children with developmental speech sound disorders. Critical reviews of the research evidence…

  8. A Survey on Clinical Research Training Status and Needs in Public Hospitals from Shenzhen

    Science.gov (United States)

    Ji, Ping; Wang, Haibo; Zhang, Chao; Liu, Min; Zhou, Liping; Xiao, Ping; Wang, Yanfang; Wu, Yangfeng

    2017-01-01

    Objective: To obtain information on the current clinical research training status and evaluate the training needs comprehensively for medical staff in hospitals. Methods: This survey was initiated and conducted by the Health and Family Planning Commission of Shenzhen in conjunction with the Peking University Clinical Research Institute (Shenzhen)…

  9. Design and interpretation of clinical research studies in oral medicine: a brief review.

    Science.gov (United States)

    Atkinson, J C; Clark, D B

    2016-03-01

    The objective of this short review is to help researchers improve the designs of their clinical studies. Also included is a discussion of the level of evidence provided by the various clinical research study designs. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

  10. A qualitative study on acceptable levels of risk for pregnant women in clinical research

    NARCIS (Netherlands)

    van der Zande, Indira S. E.; van der Graaf, Rieke; Oudijk, Martijn A.; van Delden, Johannes J. M.

    2017-01-01

    There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical

  11. Visual Impairment/Intracranial Pressure Research Clinical Advisory Panel (RCAP) Meeting. [Summary Report

    Science.gov (United States)

    Villarreal, Jennifer

    2014-01-01

    The Visual Impairment/Intracranial Pressure (VIIP) Research and Clinical Advisory Panel convened on December 1, 2014 at the ISS Conference Facility in Houston. The panel members were provided updates to the current clinical cases and treatment plans along with the latest research activities (http://humanresearchroadmap.nasa.gov/Risks/?i=105) and preliminary study results. The following is a summary of this meeting.

  12. Change in stated clinical practice associated with participation in the Dental Practice-Based Research Network

    DEFF Research Database (Denmark)

    Gilbert, Gregg H; Richman, Joshua S; Qvist, Vibeke

    2010-01-01

    Clinical researchers have attempted many methods to translate scientific evidence into routine clinical practice, with varying success. Practice-based research networks (PBRNs) provide an important, practitioner-friendly venue to test these methods. Dentist practitioner-investigators from the Den...

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

    Science.gov (United States)

    Shafiq, Nusrat; Malhotra, Samir

    2011-03-01

    Comprehension of informed consent form has not achieved the attention it deserves. We made a 24-item questionnaire to assess clinical research participants' comprehension of informed consent form (Contemp Clin Trials 2009;30:427-30). Due to repeated requests by clinical researchers in our country and abroad, we are publishing the questionnaire in this article. Copyright © 2010 Elsevier Inc. All rights reserved.

  14. Scientists Discover Sugar in Space

    Science.gov (United States)

    2000-06-01

    . Glycolaldehyde is a simpler molecular cousin to table sugar, the scientists say. The sugar molecule was detected in a large cloud of gas and dust some 26,000 light-years away, near the center of our Galaxy. Such clouds, often many light-years across, are the material from which new stars are formed. Though very rarified by Earth standards, these interstellar clouds are the sites of complex chemical reactions that occur over hundreds of thousands or millions of years. So far, about 120 different molecules have been discovered in these clouds. Most of these molecules contain a small number of atoms, and only a few molecules with eight or more atoms have been found in interstellar clouds. The 12 Meter Telescope "Finding glycolaldehyde in one of these interstellar clouds means that such molecules can be formed even in very rarified conditions," said Hollis. "We don't yet understand how it could be formed there," he added. "A combination of more astronomical observations and theoretical chemistry work will be required to resolve the mystery of how this molecule is formed in space." "We hope this discovery inspires renewed efforts to find even more kinds of molecules, so that, with a better idea of the total picture, we may be able to deduce the details of the prebiotic chemistry taking place in interstellar clouds," Hollis said. The discovery was made by detecting faint radio emission from the sugar molecules in the interstellar cloud. Molecules rotate end-for-end, and as they change from one rotational energy state to another, they emit radio waves at precise frequencies. The "family" of radio frequencies emitted by a particular molecule forms a unique "fingerprint" that scientists can use to identify that molecule. The scientists identified glycolaldehyde by detecting six frequencies of radio emission in what is termed the millimeter-wavelength region of the electromagnetic spectrum -- a region between more-familiar microwaves and infrared radiation. The NRAO 12 Meter Telescope

  15. (Re)Discovering University Autonomy

    DEFF Research Database (Denmark)

    Reilly, John; Turcan, Romeo V.; Bugaian, Larisa

    2016-01-01

    discussion of challenges. The other outcome is the extent to which academic colleagues in a wide-range of disciplines and not directly engaged with research on university autonomy may not perceive or engage with the wider autonomy outcomes of their work and as a result their own case studies may not fully...... identify the autonomy impact real or potential. Many academic staff take for granted university autonomy without questioning its sometimes contradictory assumptions and impacts....

  16. Workplace ageism: discovering hidden bias.

    Science.gov (United States)

    Malinen, Sanna; Johnston, Lucy

    2013-01-01

    BACKGROUND/STUDY CONTEXT: Research largely shows no performance differences between older and younger employees, or that older workers even outperform younger employees, yet negative attitudes towards older workers can underpin discrimination. Unfortunately, traditional "explicit" techniques for assessing attitudes (i.e., self-report measures) have serious drawbacks. Therefore, using an approach that is novel to organizational contexts, the authors supplemented explicit with implicit (indirect) measures of attitudes towards older workers, and examined the malleability of both. This research consists of two studies. The authors measured self-report (explicit) attitudes towards older and younger workers with a survey, and implicit attitudes with a reaction-time-based measure of implicit associations. In addition, to test whether attitudes were malleable, the authors measured attitudes before and after a mental imagery intervention, where the authors asked participants in the experimental group to imagine respected and valued older workers from their surroundings. Negative, stable implicit attitudes towards older workers emerged in two studies. Conversely, explicit attitudes showed no age bias and were more susceptible to change intervention, such that attitudes became more positive towards older workers following the experimental manipulation. This research demonstrates the unconscious nature of bias against older workers, and highlights the utility of implicit attitude measures in the context of the workplace. In the current era of aging workforce and skill shortages, implicit measures may be necessary to illuminate hidden workplace ageism.

  17. Financial Conflicts of Interest Checklist 2010 for clinical research studies.

    Science.gov (United States)

    Rochon, Paula A; Hoey, John; Chan, An-Wen; Ferris, Lorraine E; Lexchin, Joel; Kalkar, Sunila R; Sekeres, Melanie; Wu, Wei; Van Laethem, Marleen; Gruneir, Andrea; Maskalyk, James; Streiner, David L; Gold, Jennifer; Taback, Nathan; Moher, David

    2010-01-01

    A conflict of interest is defined as "a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)" [Thompson DF. Understanding financial conflicts of interest. N Engl J Med 1993;329(8):573-576]. Because financial conflict of interest (fCOI) can occur at different stages of a study, and because it can be difficult for investigators to detect their own bias, particularly retrospectively, we sought to provide funders, journal editors and other stakeholders with a standardized tool that initiates detailed reporting of different aspects of fCOI when the study begins and continues that reporting throughout the study process to publication. We developed a checklist using a 3-phase process of pre-meeting item generation, a stakeholder meeting and post-meeting consolidation. External experts (n = 18), research team members (n = 12) and research staff members (n = 4) rated or reviewed items for some or all of the 7 major iterations. The resulting Financial Conflicts of Interest Checklist 2010 consists of 4 sections covering administrative, study, personal financial, and authorship information, which are divided into 6 modules and contain a total of 15 items and their related sub-items; it also includes a glossary of terms. The modules are designed to be completed by all investigators at different points over the course of the study, and updated information can be appended to the checklist when it is submitted to stakeholder groups for review. We invite comments and suggestions for improvement at http://www.openmedicine.ca/fcoichecklist and ask stakeholder groups to endorse the use of the checklist.

  18. New challenges of geriatric cardiology: from clinical to preclinical research

    Science.gov (United States)

    Malavolta, Marco; Caraceni, Daniele; Olivieri, Fabiola; Antonicelli, Roberto

    2017-01-01

    The field of geriatric cardiology reflects the evolving medical approaches tailored to address the needs of the growing population of oldest old with cardiovascular diseases (CVD). The burden of CVD is expected to increase particularly for the most common types of chronic heart disease of the elderly including coronary artery disease, heart failure and atrial fibrillation. In this context of dramatic demographic changes, geriatric cardiologists are facing important challenges. In this review, we outline the basic concepts of geriatric cardiology and describe these challenges as well as the unmet needs around this discipline with also a focus on the translation from basic research. PMID:28663759

  19. Research on Clinical Decisions Made Daily in Family Medicine.

    Science.gov (United States)

    Bowman, Marjorie A; Neale, Anne Victoria; Seehusen, Dean A

    2017-01-01

    This issue presents research on the types of decisions that are required daily in family medicine. Patients often make these health decisions, and family physicians help patients with these decisions daily. Patients and their family physicians discuss when to quit screening for colon cancer, which treatment to choose for localized prostate cancer, when to test for pertussis when a cough is present, whether to take prescribed medications, how to complete more preventive services, and how to understand the "new genetics", and family physician use of telehealth. © Copyright 2017 by the American Board of Family Medicine.

  20. Pathophysiology, research challenges, and clinical management of smoke inhalation injury.

    Science.gov (United States)

    Enkhbaatar, Perenlei; Pruitt, Basil A; Suman, Oscar; Mlcak, Ronald; Wolf, Steven E; Sakurai, Hiroyuki; Herndon, David N

    2016-10-01

    Smoke inhalation injury is a serious medical problem that increases morbidity and mortality after severe burns. However, relatively little attention has been paid to this devastating condition, and the bulk of research is limited to preclinical basic science studies. Moreover, no worldwide consensus criteria exist for its diagnosis, severity grading, and prognosis. Therapeutic approaches are highly variable depending on the country and burn centre or hospital. In this Series paper, we discuss understanding of the pathophysiology of smoke inhalation injury, the best evidence-based treatments, and challenges and future directions in diagnostics and management. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial.

    Science.gov (United States)

    Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M

    2015-04-01

    A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  2. Bridging the Measurement Gap Between Research and Clinical Care in Schizophrenia

    DEFF Research Database (Denmark)

    Østergaard, Søren D; Opler, Mark G A; Correll, Christoph U

    2017-01-01

    There is currently a "measurement gap" between research and clinical care in schizophrenia. The main reason behind this gap is that the most widely used rating scale in schizophrenia research, the 30-item Positive and Negative Syndrome Scale (PANSS), takes so long to administer that it is rarely...... used in clinical practice. This compromises the translation of research findings into clinical care and vice versa. The aim of this paper is to discuss how this measurement gap can be closed. Specifically, the main points of discussion are 1) the practical problems associated with using the full 30......-25-minute, stand-alone Simplified Negative and Positive Symptoms Interview (SNAPSI), might help bridge the measurement gap between research and clinical care in schizophrenia. The full 30-item PANSS is often used in research studies, but is too time consuming to allow for routine clinical use. Recent...

  3. Scientists discover planetary system similar to our own

    CERN Multimedia

    2003-01-01

    'An international team of scientists has discovered a planet and star that may share the same relationship as Jupiter and our Sun, the closest comparison that researchers have found since they began their search for extra-solar planets nearly a decade ago' (1 page).

  4. US NSF: scientists discover planetary system similar to our own

    CERN Multimedia

    2003-01-01

    An international team of scientists has discovered a planet and star that may share the same relationship as Jupiter and our Sun, the closest comparison that researchers have found since they began their search for extra-solar planets nearly a decade ago (1 page).

  5. REVIEW: Discovering Statistics Using SPSS for Windows ANDY FIELD (2000)

    OpenAIRE

    SHARMA, Reviewed By Ashok

    2002-01-01

    The book "Discovering Statistics Using SPSS for Windows" is exactly that! Since it calculates amazingly fast, in the recent years, the computer has become the most useful and helpful tool for the researchers in almost every field of knowledge - be it open and distance education, psychology, sociology, management or else.

  6. Biomaterials in Cardiovascular Research: Applications and Clinical Implications

    Directory of Open Access Journals (Sweden)

    Saravana Kumar Jaganathan

    2014-01-01

    Full Text Available Cardiovascular biomaterials (CB dominate the category of biomaterials based on the demand and investments in this field. This review article classifies the CB into three major classes, namely, metals, polymers, and biological materials and collates the information about the CB. Blood compatibility is one of the major criteria which limit the use of biomaterials for cardiovascular application. Several key players are associated with blood compatibility and they are discussed in this paper. To enhance the compatibility of the CB, several surface modification strategies were in use currently. Some recent applications of surface modification technology on the materials for cardiovascular devices were also discussed for better understanding. Finally, the current trend of the CB, endothelization of the cardiac implants and utilization of induced human pluripotent stem cells (ihPSCs, is also presented in this review. The field of CB is growing constantly and many new investigators and researchers are developing interest in this domain. This review will serve as a one stop arrangement to quickly grasp the basic research in the field of CB.

  7. The research of clinical application of computed tomographic virtual gastroscopy

    International Nuclear Information System (INIS)

    Zhang Lei; Pan Zhenyu; Zhai Xiaoli; Gu Hua; Wang Yajie; Ding Yi; Wang Li; Liang Ying; Zhai Renyou

    2000-01-01

    Objective: To investigate the values, methods and findings of computed tomographic virtual gastroscopy (CTVG). Methods: Sixty-nine patients underwent the examination of spiral CT after charged air into stomachs in different cubage. The CT scan conditions were collimating width 3 mm, pitch 1.2 - 2.5, scanning speed 0.8 s/360 degree, the raw data of CT volume scan was reconstructed in overlapping rate 33% - 67%. Then the images of CTVG were built using navigator software (GE AG, USA). Results: The accuracy, sensitivity, and specificity of CTVG were 92.8%, 96.4%, and 78.6%, respectively. CTVG corresponded well with fibrous gastroscopy and specimens in demonstrating the gastric lesions. CTVG was provided with the ability of revealing the tiny lesions of chronic atrophic gastritis, chronic erosive gastritis, chronic proliferative gastritis, and acute hemorrhagic gastritis in some degree. The high quality imaging of CTVG could be obtained in condition of collimating width 3 mm, pitch 1.2 - 1.5, overlapping 50% - 67%, well hold-breath, gastric cubage in full and feasible scan positions. Conclusion: CTVG is a rising means of gastric examination and has great value in clinic applications

  8. Conceptual framework for behavioral and social science in HIV vaccine clinical research

    Science.gov (United States)

    Lau, Chuen-Yen; Swann, Edith M.; Singh, Sagri; Kafaar, Zuhayr; Meissner, Helen I.; Stansbury, James P.

    2011-01-01

    HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance. PMID:21821083

  9. Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical research.

    Science.gov (United States)

    Julé, Amélie; Furtado, Tamzin; Boggs, Liam; van Loggerenberg, Francois; Ewing, Victoria; Vahedi, Manhaz; Launois, Pascal; Lang, Trudie

    2017-01-01

    Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas-(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally.

  10. Conceptual framework for behavioral and social science in HIV vaccine clinical research.

    Science.gov (United States)

    Lau, Chuen-Yen; Swann, Edith M; Singh, Sagri; Kafaar, Zuhayr; Meissner, Helen I; Stansbury, James P

    2011-10-13

    HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance. Published by Elsevier Ltd.

  11. Importance of using basic statistics adequately in clinical research

    Directory of Open Access Journals (Sweden)

    Célio Fernando de Sousa Rodrigues

    Full Text Available Abstract Background and objective The inadequate use of basic statistics is the main responsible for scientific article misinterpretation. The purpose of this review article was to review some basic statistical topics to alert authors and readers about the importance of basic statistics proper reporting. Content A bibliographical and cross-sectional study was carried out, which analyzed publications in books and articles in the following databases: SciELO (Scientific Electronic Library Online and PubMed (Available from the National Center for Biotechnology Information. Medical research is not free from the risk of false positive and false negative results due to the choice of statistical tests and presence of small sample sizes. Conclusion Understanding the correct use of basic statistics leads to fewer errors in reporting the results of studies performed and in the interpretation of their conclusions.

  12. Subtle ethical dilemmas in geriatric management and clinical research.

    Science.gov (United States)

    Rosin, A J; van Dijk, Y

    2005-06-01

    Routine management of geriatric problems often raises ethical problems, particularly regarding autonomy of the old person. The carers or children may be unaware of the sensitivity of role reversal in dealing with the financial affairs; the need for a residential carer may compromise the old person's privacy. Attending a day centre confers much benefit, but one must understand the old person's resistance to change in the proposal of a new daily regimen. Similarly his or her autonomy must be the priority in planning for admittance to an old age home, and not the assumption that the family knows best. A common dilemma is the assessment of an old person's competency in decision making, either about management of his affairs, or regarding consent to treatment, or participation in research. Because cognitive capacity is not always identical with competency, meaningful tools have recently been developed in which the emphasis is on the specific situation to be investigated.

  13. Evidence-based therapy relationships: research conclusions and clinical practices.

    Science.gov (United States)

    Norcross, John C; Wampold, Bruce E

    2011-03-01

    In this closing article of the special issue, we present the conclusions and recommendations of the interdivisional task force on evidence-based therapy relationships. The work was based on a series of meta-analyses conducted on the effectiveness of various relationship elements and methods of treatment adaptation. A panel of experts concluded that several relationship elements were demonstrably effective (alliance in individual psychotherapy, alliance in youth psychotherapy, alliance in family therapy, cohesion in group therapy, empathy, collecting client feedback) while others were probably effective (goal consensus, collaboration, positive regard). Three other relationship elements (congruence/genuineness, repairing alliance ruptures, and managing countertransference) were deemed promising but had insufficient evidence to conclude that they were effective. Multiple recommendations for practice, training, research, and policy are advanced. (PsycINFO Database Record (c) 2011 APA, all rights reserved).

  14. Expediting Clinical and Translational Research via Bayesian Instrument Development.

    Science.gov (United States)

    Jiang, Yu; Boyle, Diane K; Bott, Marjorie J; Wick, Jo A; Yu, Qing; Gajewski, Byron J

    2014-06-01

    Developing valid and reliable instruments is crucial but costly and time-consuming in health care research and evaluation. The Food and Drug Administration and the National Institutes of Health have set up guidelines for developing patient-reported outcome instruments. However, the guidelines are not applicable to cases of small sample sizes. Instead of using an exact estimation procedure to examine psychometric properties, our Bayesian Instrument Development (BID) method integrates expert data and participant data into a single seamless analysis. Using a novel set of priors, we use simulated data to compare BID to classical instrument development procedures and test the stability of BID. To display BID to non-statisticians, a graphical user interface based on R and WINBUGS is developed and demonstrated with data on a small sample of heart failure patients. Costs were saved by eliminating the need for unnecessary continuation of data collection for larger samples as required by the classical instrument development approach.

  15. Human Locomotion in Hypogravity: From Basic Research to Clinical Applications

    Directory of Open Access Journals (Sweden)

    Francesco Lacquaniti

    2017-11-01

    Full Text Available We have considerable knowledge about the mechanisms underlying compensation of Earth gravity during locomotion, a knowledge obtained from physiological, biomechanical, modeling, developmental, comparative, and paleoanthropological studies. By contrast, we know much less about locomotion and movement in general under sustained hypogravity. This lack of information poses a serious problem for human space exploration. In a near future humans will walk again on the Moon and for the first time on Mars. It would be important to predict how they will move around, since we know that locomotion and mobility in general may be jeopardized in hypogravity, especially when landing after a prolonged weightlessness of the space flight. The combination of muscle weakness, of wearing a cumbersome spacesuit, and of maladaptive patterns of locomotion in hypogravity significantly increase the risk of falls and injuries. Much of what we currently know about locomotion in hypogravity derives from the video archives of the Apollo missions on the Moon, the experiments performed with parabolic flight or with body weight support on Earth, and the theoretical models. These are the topics of our review, along with the issue of the application of simulated hypogravity in rehabilitation to help patients with deambulation problems. We consider several issues that are common to the field of space science and clinical rehabilitation: the general principles governing locomotion in hypogravity, the methods used to reduce gravity effects on locomotion, the extent to which the resulting behavior is comparable across different methods, the important non-linearities of several locomotor parameters as a function of the gravity reduction, the need to use multiple methods to obtain reliable results, and the need to tailor the methods individually based on the physiology and medical history of each person.

  16. Human Locomotion in Hypogravity: From Basic Research to Clinical Applications

    Science.gov (United States)

    Lacquaniti, Francesco; Ivanenko, Yury P.; Sylos-Labini, Francesca; La Scaleia, Valentina; La Scaleia, Barbara; Willems, Patrick A.; Zago, Myrka

    2017-01-01

    We have considerable knowledge about the mechanisms underlying compensation of Earth gravity during locomotion, a knowledge obtained from physiological, biomechanical, modeling, developmental, comparative, and paleoanthropological studies. By contrast, we know much less about locomotion and movement in general under sustained hypogravity. This lack of information poses a serious problem for human space exploration. In a near future humans will walk again on the Moon and for the first time on Mars. It would be important to predict how they will move around, since we know that locomotion and mobility in general may be jeopardized in hypogravity, especially when landing after a prolonged weightlessness of the space flight. The combination of muscle weakness, of wearing a cumbersome spacesuit, and of maladaptive patterns of locomotion in hypogravity significantly increase the risk of falls and injuries. Much of what we currently know about locomotion in hypogravity derives from the video archives of the Apollo missions on the Moon, the experiments performed with parabolic flight or with body weight support on Earth, and the theoretical models. These are the topics of our review, along with the issue of the application of simulated hypogravity in rehabilitation to help patients with deambulation problems. We consider several issues that are common to the field of space science and clinical rehabilitation: the general principles governing locomotion in hypogravity, the methods used to reduce gravity effects on locomotion, the extent to which the resulting behavior is comparable across different methods, the important non-linearities of several locomotor parameters as a function of the gravity reduction, the need to use multiple methods to obtain reliable results, and the need to tailor the methods individually based on the physiology and medical history of each person. PMID:29163225

  17. Red Blood Cell Mechanical Fragility Test for Clinical Research Applications.

    Science.gov (United States)

    Ziegler, Luke A; Olia, Salim E; Kameneva, Marina V

    2017-07-01

    Red blood cell (RBC) susceptibility to mechanically induced hemolysis, or RBC mechanical fragility (MF), is an important parameter in the characterization of erythrocyte membrane health. The rocker bead test (RBT) and associated calculated mechanical fragility index (MFI) is a simple method for the assessment of RBC MF. Requiring a minimum of 15.5 mL of blood and necessitating adjustment of hematocrit (Ht) to a "standard" value (40%), the current RBT is not suitable for use in most studies involving human subjects. To address these limitations, we propose a 6.5 mL reduced volume RBT and corresponding modified MFI (MMFI) that does not require prior Ht adjustment. This new method was assessed for i) correlation to the existing text, ii) to quantify the effect of Ht on MFI, and iii) validation by reexamining the protective effect of plasma proteins on RBC MF. The reduced volume RBT strongly correlated (r = 0.941) with the established large volume RBT at matched Hts, and an equation was developed to calculate MMFI: a numerical estimation (R 2  = 0.923) of MFI if performed with the reduced volume RBT at "standard" (40%) Ht. An inversely proportional relationship was found between plasma protein concentration and RBC MF using the MMFI-reduced volume method, supporting previous literature findings. The new reduced volume RBT and modified MFI will allow for the measurement of RBC MF in clinical and preclinical studies involving humans or small animals. © 2017 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  18. Clinical verification of genetic results returned to research participants: findings from a Colon Cancer Family Registry.

    Science.gov (United States)

    Laurino, Mercy Y; Truitt, Anjali R; Tenney, Lederle; Fisher, Douglass; Lindor, Noralane M; Veenstra, David; Jarvik, Gail P; Newcomb, Polly A; Fullerton, Stephanie M

    2017-11-01

    The extent to which participants act to clinically verify research results is largely unknown. This study examined whether participants who received Lynch syndrome (LS)-related findings pursued researchers' recommendation to clinically verify results with testing performed by a CLIA-certified laboratory. The Fred Hutchinson Cancer Research Center site of the multinational Colon Cancer Family Registry offered non-CLIA individual genetic research results to select registry participants (cases and their enrolled relatives) from 2011 to 2013. Participants who elected to receive results were counseled on the importance of verifying results at a CLIA-certified laboratory. Twenty-six (76.5%) of the 34 participants who received genetic results completed 2- and 12-month postdisclosure surveys; 42.3% of these (11/26) participated in a semistructured follow-up interview. Within 12 months of result disclosure, only 4 (15.4%) of 26 participants reported having verified their results in a CLIA-certified laboratory; of these four cases, all research and clinical results were concordant. Reasons for pursuing clinical verification included acting on the recommendation of the research team and informing future clinical care. Those who did not verify results cited lack of insurance coverage and limited perceived personal benefit of clinical verification as reasons for inaction. These findings suggest researchers will need to address barriers to seeking clinical verification in order to ensure that the intended benefits of returning genetic research results are realized. © 2017 The Authors. Molecular Genetics & Genomic Medicine published by Wiley Periodicals, Inc.

  19. Astronomers Discover Fastest-Spinning Pulsar

    Science.gov (United States)

    2006-01-01

    Astronomers using the National Science Foundation's Robert C. Byrd Green Bank Telescope have discovered the fastest-spinning neutron star ever found, a 20-mile-diameter superdense pulsar whirling faster than the blades of a kitchen blender. Their work yields important new information about the nature of one of the most exotic forms of matter known in the Universe. Pulsar Graphic Pulsars Are Spinning Neutron Stars CREDIT: Bill Saxton, NRAO/AUI/NSF (Click on image for larger version) "We believe that the matter in neutron stars is denser than an atomic nucleus, but it is unclear by how much. Our observations of such a rapidly rotating star set a hard upper limit on its size, and hence on how dense the star can be.," said Jason Hessels, a graduate student at McGill University in Montreal. Hessels and his colleagues presented their findings to the American Astronomical Society's meeting in Washington, DC. Pulsars are spinning neutron stars that sling "lighthouse beams" of radio waves or light around as they spin. A neutron star is what is left after a massive star explodes at the end of its "normal" life. With no nuclear fuel left to produce energy to offset the stellar remnant's weight, its material is compressed to extreme densities. The pressure squeezes together most of its protons and electrons to form neutrons; hence, the name "neutron star." "Neutron stars are incredible laboratories for learning about the physics of the fundamental particles of nature, and this pulsar has given us an important new limit," explained Scott Ransom, an astronomer at the National Radio Astronomy Observatory and one of Hessels' collaborators on this work. The scientists discovered the pulsar, named PSR J1748-2446ad, in a globular cluster of stars called Terzan 5, located some 28,000 light-years from Earth in the constellation Sagittarius. The newly-discovered pulsar is spinning 716 times per second, or at 716 Hertz (Hz), readily beating the previous record of 642 Hz from a pulsar

  20. New directions in hypnosis research: strategies for advancing the cognitive and clinical neuroscience of hypnosis

    OpenAIRE

    Jensen, Mark P.; Jamieson, Graham A.; Lutz, Antoine; Mazzoni, Giuliana; McGeown, William J.; Santarcangelo, Enrica L.; Demertzi, Athena; De Pascalis, Vilfredo; Bányai, Éva I.; Rominger, Christian; Vuilleumier, Patrik; Faymonville, Marie-Elisabeth; Terhune, Devin B.

    2017-01-01

    This article summarizes key advances in hypnosis research during the past two decades, including (i) clinical research supporting the efficacy of hypnosis for managing a number of clinical symptoms and conditions, (ii) research supporting the role of various divisions in the anterior cingulate and prefrontal cortices in hypnotic responding, and (iii) an emerging finding that high hypnotic suggestibility is associated with atypical brain connectivity profiles. Key recommendations for a researc...

  1. [Clinical research on children mental retardation treated with acupuncture].

    Science.gov (United States)

    Huang, Jin-Bai; Cao, Hui-Fang; Hu, Jiao; Liu, Long-Hao; Wang, Zhi; Lin, Hai

    2013-08-01

    . It indicates the satisfactory clinical efficacy. But, the fMRI brain function images do not change apparently before and after treatment.

  2. From biomedical-engineering research to clinical application and industrialization

    Science.gov (United States)

    Taguchi, Tetsushi; Aoyagi, Takao

    2012-12-01

    The rising costs and aging of the population due to a low birth rate negatively affect the healthcare system in Japan. In 2011, the Council for Science and Technology Policy released the 4th Japan's Science and Technology Basic Policy Report from 2011 to 2015. This report includes two major innovations, 'Life Innovation' and 'Green Innovation', to promote economic growth. Biomedical engineering research is part of 'Life Innovation' and its outcomes are required to maintain people's mental and physical health. It has already resulted in numerous biomedical products, and new ones should be developed using nanotechnology-based concepts. The combination of accumulated knowledge and experience, and 'nanoarchitechtonics' will result in novel, well-designed functional biomaterials. This focus issue contains three reviews and 19 original papers on various biomedical topics, including biomaterials, drug-delivery systems, tissue engineering and diagnostics. We hope that it demonstrates the importance of collaboration among scientists, engineers and clinicians, and will contribute to the further development of biomedical engineering.

  3. Natural Language Processing Technologies in Radiology Research and Clinical Applications

    Science.gov (United States)

    Cai, Tianrun; Giannopoulos, Andreas A.; Yu, Sheng; Kelil, Tatiana; Ripley, Beth; Kumamaru, Kanako K.; Rybicki, Frank J.

    2016-01-01

    The migration of imaging reports to electronic medical record systems holds great potential in terms of advancing radiology research and practice by leveraging the large volume of data continuously being updated, integrated, and shared. However, there are significant challenges as well, largely due to the heterogeneity of how these data are formatted. Indeed, although there is movement toward structured reporting in radiology (ie, hierarchically itemized reporting with use of standardized terminology), the majority of radiology reports remain unstructured and use free-form language. To effectively “mine” these large datasets for hypothesis testing, a robust strategy for extracting the necessary information is needed. Manual extraction of information is a time-consuming and often unmanageable task. “Intelligent” search engines that instead rely on natural language processing (NLP), a computer-based approach to analyzing free-form text or speech, can be used to automate this data mining task. The overall goal of NLP is to translate natural human language into a structured format (ie, a fixed collection of elements), each with a standardized set of choices for its value, that is easily manipulated by computer programs to (among other things) order into subcategories or query for the presence or absence of a finding. The authors review the fundamentals of NLP and describe various techniques that constitute NLP in radiology, along with some key applications. ©RSNA, 2016 PMID:26761536

  4. Smartphones Offer New Opportunities in Clinical Voice Research.

    Science.gov (United States)

    Manfredi, C; Lebacq, J; Cantarella, G; Schoentgen, J; Orlandi, S; Bandini, A; DeJonckere, P H

    2017-01-01

    Smartphone technology provides new opportunities for recording standardized voice samples of patients and sending the files by e-mail to the voice laboratory. This drastically improves the collection of baseline data, as used in research on efficiency of voice treatments. However, the basic requirement is the suitability of smartphones for recording and digitizing pathologic voices (mainly characterized by period perturbations and noise) without significant distortion. In this experiment, two smartphones (a very inexpensive one and a high-level one) were tested and compared with direct microphone recordings in a soundproof room. The voice stimuli consisted in synthesized deviant voice samples (median of fundamental frequency: 120 and 200 Hz) with three levels of jitter and three levels of added noise. All voice samples were analyzed using PRAAT software. The results show high correlations between jitter, shimmer, and noise-to-harmonics ratio measured on the recordings via both smartphones, the microphone, and measured directly on the sound files from the synthesizer. Smartphones thus appear adequate for reliable recording and digitizing of pathologic voices. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  5. Natural Language Processing Technologies in Radiology Research and Clinical Applications.

    Science.gov (United States)

    Cai, Tianrun; Giannopoulos, Andreas A; Yu, Sheng; Kelil, Tatiana; Ripley, Beth; Kumamaru, Kanako K; Rybicki, Frank J; Mitsouras, Dimitrios

    2016-01-01

    The migration of imaging reports to electronic medical record systems holds great potential in terms of advancing radiology research and practice by leveraging the large volume of data continuously being updated, integrated, and shared. However, there are significant challenges as well, largely due to the heterogeneity of how these data are formatted. Indeed, although there is movement toward structured reporting in radiology (ie, hierarchically itemized reporting with use of standardized terminology), the majority of radiology reports remain unstructured and use free-form language. To effectively "mine" these large datasets for hypothesis testing, a robust strategy for extracting the necessary information is needed. Manual extraction of information is a time-consuming and often unmanageable task. "Intelligent" search engines that instead rely on natural language processing (NLP), a computer-based approach to analyzing free-form text or speech, can be used to automate this data mining task. The overall goal of NLP is to translate natural human language into a structured format (ie, a fixed collection of elements), each with a standardized set of choices for its value, that is easily manipulated by computer programs to (among other things) order into subcategories or query for the presence or absence of a finding. The authors review the fundamentals of NLP and describe various techniques that constitute NLP in radiology, along with some key applications. ©RSNA, 2016.

  6. Developing a clinical trial unit to advance research in an academic institution.

    Science.gov (United States)

    Croghan, Ivana T; Viker, Steven D; Limper, Andrew H; Evans, Tamara K; Cornell, Alissa R; Ebbert, Jon O; Gertz, Morie A

    2015-11-01

    Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trial unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine clinical trial unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a central unit to provide research support in clinical trials and presents the advantages, disadvantages, and required building blocks for such a unit. Copyright © 2015 Mayo Clinic. Published by Elsevier Inc. All rights reserved.

  7. [Controlling methods of clinical research on acu-moxibustion commonly used of abroad].

    Science.gov (United States)

    Wang, Xin-juan; Zhao, Bai-xiao

    2006-06-01

    With the application of scientific studying methods, the level of clinical study has been improved greatly, and people has been paid more attention to scientific evaluation of the clinical effect of Chinese medicine and acu-moxibustion. Formerly, because of lack in acceptance and application of modern scientific studying methods in Chinese clinical acu-moxibustion researchers, their achievements weren't approved by the international academy for the faulty model of study. Randomized Control Trial (RCT) is the golden standard method widely accepted at present, so it is of great importance for clinical acu-moxibustion researchers to exert control methods correctly and effectively. The commonly used controlling methods of overseas clinical acu-moxibustion studies were discussed in this article in order to give some suggestion and benifits to the internal acu-moxibustion clinical researchers.

  8. Pre-clinical research in small animals using radiotherapy technology--a bidirectional translational approach.

    Science.gov (United States)

    Tillner, Falk; Thute, Prasad; Bütof, Rebecca; Krause, Mechthild; Enghardt, Wolfgang

    2014-12-01

    For translational cancer research, pre-clinical in-vivo studies using small animals have become indispensable in bridging the gap between in-vitro cell experiments and clinical implementation. When setting up such small animal experiments, various biological, technical and methodical aspects have to be considered. In this work we present a comprehensive topical review based on relevant publications on irradiation techniques used for pre-clinical cancer research in mice and rats. Clinical radiotherapy treatment devices for the application of external beam radiotherapy and brachytherapy as well as dedicated research irradiation devices are feasible for small animal irradiation depending on the animal model and the experimental goals. In this work, appropriate solutions for the technological transfer of human radiation oncology to small animal radiation research are summarised. Additionally, important information concerning the experimental design is provided such that reliable and clinically relevant results can be attained. Copyright © 2014. Published by Elsevier GmbH.

  9. How to design and write a clinical research protocol in Cosmetic Dermatology*

    Science.gov (United States)

    Bagatin, Ediléia; Miot, Helio A.

    2013-01-01

    Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

  10. The role of Clinical Trial Units in investigator- and industry-initiated research projects.

    Science.gov (United States)

    von Niederhäusern, Belinda; Fabbro, Thomas; Pauli-Magnus, Christiane

    2015-01-01

    Six multidisciplinary competence centres (Clinical Trial Units, CTUs) in Basel, Berne, Geneva, Lausanne, St. Gallen and Zurich provide professional support to clinical researchers in the planning, implementation, conduct and evaluation of clinical studies. Through their coordinated network, these units promote high-quality, nationally harmonised and internationally standardised clinical research conduct in Switzerland. We will describe why this network has been established, how it has been successful in stilling the growing need for clinical research support, which training and education opportunities it offers, and how it created national awareness for the still-existing hurdles towards clinical research excellence in Switzerland. Taking the CTU Basel as an example, we show that a considerable number (25%) of the studies submitted for regulatory approval in 2013 were supported by the CTU, decreasing the number of findings in ethics reviews by about one-third. We conclude that these achievements, together with a Swiss national funding model for clinical research, and improved national coordination, will be critical factors to successfully position Swiss clinical research at the international forefront.

  11. How does knowledge from translational research impact our clinical care of pediatric inflammatory bowel disease patients?

    Science.gov (United States)

    Denson, Lee A

    2012-06-01

    Recent translational studies have provided new insights into pathogenesis, disease behavior, and treatment responses in pediatric Inflammatory Bowel Disease (IBD). Registry studies have identified distinct clinical phenotypes with increasing age of onset; this has led to a revision of the clinical phenotyping system, now termed the Paris classification system. It is recognized that there are infantile (age <2 years), very early onset (VEO, age 2-10), and early onset (EO, age 10-17) forms of disease. Rare genetic mutations affecting anti-microbial and anti-inflammatory pathways have been discovered in infantile and VEO forms, while genetic pathways identified in EO disease have been similar to adult-onset IBD. Genetic and serologic patterns measured soon after diagnosis have been shown to be associated with more aggressive stricturing behavior; these patterns may now be used clinically to help predict disease course. More recently, clinical and genetic models have been developed that, if validated, could be used to predict treatment responses.

  12. Alcohol use disorder clinical course research: informing clinicians' treatment planning now and in the future.

    Science.gov (United States)

    Maisto, Stephen A; Kirouac, Megan; Witkiewitz, Katie

    2014-09-01

    The clinical course of alcohol use disorder (AUD) has been widely researched over the past half-century and has been used to advance our understanding of the treatment of AUD. Nevertheless, new directions in AUD clinical course research could enhance its value in informing clinical decision-making in patient-centered treatment of AUD. An overview, a critical analysis, and a discussion of AUD clinical course research are presented. This article discusses three research directions that promote the advancement of the knowledge regarding the clinical course of AUD to better inform clinical decision-making in patient-centered treatment of AUD. Specifically, we hypothesized that (a) real-time data collection of the clinical course of AUD via ecological momentary assessment would help elucidate near real-time associations between risk factors and alcohol use, (b) future research designs should use person-centered and dynamic analyses of alcohol use over time, and (c) adaptive treatment designs would provide personalized and optimized AUD treatment. Consequently, the field will advance the development of clinical decision-making support systems to better inform clinicians and clients in making informed AUD treatment decisions. In addition, such research would advance clinical practice with more attention to theory and expansion of the study of the clinical course of AUD to include areas of life functioning besides alcohol use. These research directions have the potential to build a scientific knowledge base that could improve our understanding of AUD among individuals with alcohol problems, would allow providers to predict patient outcomes during and after treatment, and would offer practical strategies regarding steps that could ultimately improve the clinical course of AUD.

  13. Emerging role of bioinformatics tools and software in evolution of clinical research

    Directory of Open Access Journals (Sweden)

    Supreet Kaur Gill

    2016-01-01

    Full Text Available Clinical research is making toiling efforts for promotion and wellbeing of the health status of the people. There is a rapid increase in number and severity of diseases like cancer, hepatitis, HIV etc, resulting in high morbidity and mortality. Clinical research involves drug discovery and development whereas clinical trials are performed to establish safety and efficacy of drugs. Drug discovery is a long process starting with the target identification, validation and lead optimization. This is followed by the preclinical trials, intensive clinical trials and eventually post marketing vigilance for drug safety. Softwares and the bioinformatics tools play a great role not only in the drug discovery but also in drug development. It involves the use of informatics in the development of new knowledge pertaining to health and disease, data management during clinical trials and to use clinical data for secondary research. In addition, new technology likes molecular docking, molecular dynamics simulation, proteomics and quantitative structure activity relationship in clinical research results in faster and easier drug discovery process. During the preclinical trials, the software is used for randomization to remove bias and to plan study design. In clinical trials software like electronic data capture, Remote data capture and electronic case report form (eCRF is used to store the data. eClinical, Oracle clinical are software used for clinical data management and for statistical analysis of the data. After the drug is marketed the safety of a drug could be monitored by drug safety software like Oracle Argus or ARISg. Therefore, softwares are used from the very early stages of drug designing, to drug development, clinical trials and during pharmacovigilance. This review describes different aspects related to application of computers and bioinformatics in drug designing, discovery and development, formulation designing and clinical research.

  14. MO-C-BRB-00: President’s Symposium: Revitalizing Scientific Excellence: Turning Research Into Clinical Reality Through Translational Research

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2015-06-15

    Diagnostic radiology and radiation oncology are arguably two of the most technologically advanced specialties in medicine. The imaging and radiation medicine technologies in clinical use today have been continuously improved through new advances made in the commercial and academic research arenas. This symposium explores the translational path from research through clinical implementation. Dr. Pettigrew will start this discussion by sharing his perspectives as director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The NIBIB has focused on promoting research that is technological in nature and has high clinical impact. We are in the age of precision medicine, and the technological innovations and quantitative tools developed by engineers and physicists working with physicians are providing innovative tools that increase precision and improve outcomes in health care. NIBIB funded grants lead to a very high patenting rate (per grant dollar), and these patents have higher citation rates by other patents, suggesting greater clinical impact, as well. Two examples of clinical translation resulting from NIH-funded research will be presented, in radiation therapy and diagnostic imaging. Dr. Yu will describe a stereotactic radiotherapy device developed in his laboratory that is designed for treating breast cancer with the patient in the prone position. It uses 36 rotating Cobalt-60 sources positioned in an annular geometry to focus the radiation beam at the system’s isocenter. The radiation dose is delivered throughout the target volume in the breast by constantly moving the patient in a planned trajectory relative to the fixed isocenter. With this technique, the focal spot dynamically paints the dose distribution throughout the target volume in three dimensions. Dr. Jackson will conclude this symposium by describing the RSNA Quantitative Imaging Biomarkers Alliance (QIBA), which is funded in part by NIBIB and is a synergistic collaboration

  15. MO-C-BRB-00: President’s Symposium: Revitalizing Scientific Excellence: Turning Research Into Clinical Reality Through Translational Research

    International Nuclear Information System (INIS)

    2015-01-01

    Diagnostic radiology and radiation oncology are arguably two of the most technologically advanced specialties in medicine. The imaging and radiation medicine technologies in clinical use today have been continuously improved through new advances made in the commercial and academic research arenas. This symposium explores the translational path from research through clinical implementation. Dr. Pettigrew will start this discussion by sharing his perspectives as director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The NIBIB has focused on promoting research that is technological in nature and has high clinical impact. We are in the age of precision medicine, and the technological innovations and quantitative tools developed by engineers and physicists working with physicians are providing innovative tools that increase precision and improve outcomes in health care. NIBIB funded grants lead to a very high patenting rate (per grant dollar), and these patents have higher citation rates by other patents, suggesting greater clinical impact, as well. Two examples of clinical translation resulting from NIH-funded research will be presented, in radiation therapy and diagnostic imaging. Dr. Yu will describe a stereotactic radiotherapy device developed in his laboratory that is designed for treating breast cancer with the patient in the prone position. It uses 36 rotating Cobalt-60 sources positioned in an annular geometry to focus the radiation beam at the system’s isocenter. The radiation dose is delivered throughout the target volume in the breast by constantly moving the patient in a planned trajectory relative to the fixed isocenter. With this technique, the focal spot dynamically paints the dose distribution throughout the target volume in three dimensions. Dr. Jackson will conclude this symposium by describing the RSNA Quantitative Imaging Biomarkers Alliance (QIBA), which is funded in part by NIBIB and is a synergistic collaboration

  16. Integrating Research Into Clinical Internship Training Bridging the Science/Practice Gap in Pediatric Psychology

    Science.gov (United States)

    Spirito, Anthony

    2012-01-01

    Existing literature highlights a critical gap between science and practice in clinical psychology. The internship year is a “capstone experience”; training in methods of scientific evaluation should be integrated with the development of advanced clinical competencies. We provide a rationale for continued exposure to research during the clinical internship year, including, (a) critical examination and integration of the literature regarding evidence-based treatment and assessment, (b) participation in faculty-based and independent research, and (c) orientation to the science and strategy of grantsmanship. Participation in research provides exposure to new empirical models and can foster the development of applied research questions. Orientation to grantsmanship can yield an initial sense of the “business of science.” Internship provides an important opportunity to examine the challenges to integrating the clinical evidence base into professional practice; for that reason, providing research exposure on internship is an important strategy in training the next generation of pediatric psychologists. PMID:22286345

  17. [Literature regarding clinical research of acupuncture for depression in the worldwide:comparison and discussion].

    Science.gov (United States)

    Kou, Renzhong; Jiang, Yu; Xu, Tiancheng; Yu, Meiling; Wang, Xinjun; Lu, Shengfeng

    The literature regarding clinical research of acupuncture for depression published in Wanfang database, VIP database, CNKI database and PubMed from January of 2004 to March of 2005 was collected, and the quality of randomized controlled trial (RCT) that met the inclusive criteria was evaluated with Jadad. The research designs (research objective, intervention, effect assessment) were compared and analyzed by using the 2010 version of Consolidated Standards of Reporting Trials (CONSORT) and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). As a result, a total of 57 articles were included in the comparative study, 46 of which were RCTs (36 articles were published in China core journals, 6 articles written by China were published in foreign countries, and 4 articles were foreign researches). It was found the literature of Chinese researches attached great importance to the syndrome differentiation of acupuncture, and various types of acupuncture intervention and biological effect indicators were applied; the literature of foreign researches presented advantages on RCT quality, and the baseline evaluation and effect evaluation systems were more comprehensive, in addition, more attention was paid to quantitative design of clinical parameters. It was concluded the differences between Chinese and foreign clinical research of acupuncture for depression were unfavorable for the evidence-based research, and the overall quality of researches was in need of improvement. It was recommended the future researchers should be designed and reported in accord with unified criteria, and the registration of acupuncture clinical trial should be valued, which could promote the integration of research results and improve the overall researches level. In this process, the research model of real world might be introduced to stimulate new development trends of acupuncture clinical research.

  18. Rightsizing Projects for Non-Research-Intensive Schools of Nursing via Academic-Clinical Partnerships.

    Science.gov (United States)

    Kooken, Wendy Carter; Eckhardt, Ann L; McNutt-Dungan, Marianne; Woods, Jonathan

    Most academic-clinical partnerships are described as formal agreements between schools of nursing at research-intensive universities and large teaching hospitals. This article demonstrates less formal versions of academic-clinical partnerships established between a small, private liberal arts university school of nursing and 2 regional clinical agencies. In both exemplars, students, faculty, and staff contributed to evidence-based practice projects. Schools of nursing in non-research-intensive environments can develop right-size academic-clinical partnerships that are beneficial for all parties involved.

  19. Clinical Pharmacology Research Internships at the Interface between Academia and Industry : Students' Perceptions and Scientific Output

    NARCIS (Netherlands)

    Goulooze, S.C.; Franson, K.; Cohen, A.F.; Rissmann, R.

    2017-01-01

    The Centre for Human Drug Research (CHDR) is a non-profit clinical research institute at the interface between academia and the pharmaceutical industry. CHDR hosts a research internship programme for undergraduate (bio)medical students. The aim of this study was (i) to investigate the student

  20. Consistency between Research and Clinical Diagnoses of Autism among Boys and Girls with Fragile X Syndrome

    Science.gov (United States)

    Klusek, J.; Martin, G. E.; Losh, M.

    2014-01-01

    Background: Prior research suggests that 60-74% of males and 16-45% of females with fragile X syndrome (FXS) meet criteria for autism spectrum disorder (ASD) in research settings. However, relatively little is known about the rates of clinical diagnoses in FXS and whether such diagnoses are consistent with those performed in a research setting…