Sample records for novice clinical researchers

  1. How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study. (United States)

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


    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

  2. On novice facilitators doing research

    DEFF Research Database (Denmark)

    Tavella, Elena


    Opportunities for novices to facilitate Problem Structuring Methods (PSMs) workshops are limited, especially because of a lack of access to real-world interventions and confidence in their capabilities. Novices are usually young academics building their careers through publishing. Publishing...... is challenging if facilitation and opportunities for data collection are limited. To address this challenge, this paper suggests autoethnography as a framework for addressing difficulties that novices face in conducting research and publishing on PSMs. This suggestion grows out of a literature study...

  3. Clinical decision-making of rural novice nurses. (United States)

    Seright, T J


    Nurses in rural settings are often the first to assess and interpret the patient's clinical presentations. Therefore, an understanding of how nurses experience decision-making is important in terms of educational preparation, resource allocation to rural areas, institutional cultures, and patient outcomes. Theory development was based on the in-depth investigation of 12 novice nurses practicing in rural critical access hospitals in a north central state. This grounded theory study consisted of face-to-face interviews with 12 registered nurses, nine of whom were observed during their work day. The participants were interviewed a second time, as a method of member checking, and during this interview they reviewed their transcripts, the emerging themes and categories. Directors of nursing from both the research sites and rural hospitals not involved in the study, experienced researchers, and nurse educators facilitated triangulation of the findings. 'Sociocentric rationalizing' emerged as the central phenomenon and referred to the sense of belonging and agency which impacted the decision-making in this small group of novice nurses in rural critical access hospitals. The observed consequences, which were conceptualized during the axial coding process and were derived from observations and interviews of the 12 novice nurses in this study include: (1) gathering information before making a decision included assessment of: the credibility of co-workers, patients' subjective and objective data, and one's own past and current experiences; (2) conferring with co-workers as a direct method of confirming/denying decisions being made was considered more realistic and expedient than policy books and decision trees; (3) rural practicum clinical experiences, along with support after orientation, provide for transition to the rural nurse role; (4) involved directors of nursing served as both models and protectors of novice nurses placed in high accountability positions early in

  4. Training Impact on Novice and Experienced Research Coordinators. (United States)

    Behar-Horenstein, Linda S; Potter, JoNell Efantis; Prikhidko, Alena; Swords, Stephanie; Sonstein, Stephen; Kolb, H Robert


    Competency-based training and professional development is critical to the clinical research enterprise. Understanding research coordinators' perspectives is important for establishing a common core curriculum. The purpose of this study was to describe participants' perspectives regarding the impact of online and classroom training sessions. 27 participants among three institutions, completed a two-day classroom training session. 10 novice and seven experienced research coordinators participated in focus group interviews. Grounded theory revealed similarities in novice and experienced coordinator themes including Identifying Preferences for Instruction and Changing Self Perceptions. Differences, seen in experienced participants, focused on personal change, in the theme of Re-Assessing Skills. Infrastructure and cultural issues were evident in their theme, Promoting Leadership and Advocacy. Novice participants recommended ways to improve training via their theme of Making Programmatic Improvements. Participants reported a clear preference for classroom learning. Training played an influential role in changing participants' self-perceptions by validating their experiences. The findings provided guidance for developing a standardized curriculum. Training must be carefully tailored to the needs of participants while considering audience needs based on work experience, how technology can be used and offering content that is most urgently needed.

  5. The Evolution of the Personal Networks of Novice Librarian Researchers (United States)

    Kennedy, Marie R.; Kennedy, David P.; Brancolini, Kristine R.


    This article describes for the first time the composition and structure of the personal networks of novice librarian researchers. We used social network analysis to observe if participating in the Institute for Research Design in Librarianship (IRDL) affected the development of the librarians' personal networks and how the networks changed over…

  6. A novice researcher's reflection on recruiting participants for qualitative research. (United States)

    Marks, Anne; Wilkes, Lesley; Blythe, Stacy; Griffiths, Rhonda


    This paper is a reflection by a PhD candidate on her qualitative study involving parents, diabetes educators and school teachers who were caring for a child with type 1 diabetes using intensive insulin therapy in primary school. To reflect on a novice researcher's experience of recruiting research participants from community, health and education settings in Australia. Participants were successfully recruited for the study using internet communication tools: Facebook support groups; the Australian Diabetes Educators Association (ADEA) e-newsletter; and emails sent to school principals. These methods were successful as Facebook and online support groups are popular, the study topic was of interest, the ADEA has many members, and numerous emails were sent to schools. Potential barriers to recruitment were a lack of access to those who did not use Facebook or the internet, gatekeepers, the high workloads of diabetes educators and teachers, and the time needed to obtain ethics approval and send a large number of emails to schools. Internet communication tools were successful in recruiting participants from community, health and education settings. However, different approaches were required for each type of participant. Lessons learned from this experience were: the importance of taking time to plan recruitment, including an in-depth understanding of potential participants and recruitment tools, the benefit of being an insider, and the need to work closely with gatekeepers. An understanding of recruitment is essential for ensuring access to appropriate participants and timely collection of data. The experience of the novice researcher may provide insight to others planning to use internet communication tools for recruitment. ©2012 RCN Publishing Company Ltd. All rights reserved. Not to be copied, transmitted or recorded in any way, in whole or part, without prior permission of the publishers.

  7. Using videorecording to enhance the development of novice researchers´ interviewing skills

    DEFF Research Database (Denmark)

    Uhrenfeldt, Lisbeth; Paterson, Barbara; Hall, Elisabeth


    Abstract: Little has been written about how to teach novice researchers about qualitative research interviewing. In this article, the authors recognize qualitative research interviewing as a practice that one develops through reflexivity. They propose that novices can develop a reflexive...... to enhance the development of novice researchers as qualitative research interviewers....... interviewing practice by using a guided framework to review video records of the interviews they conduct. The authors discuss the framework and illustrate its use with an exemplar derived from the experience of a novice researcher. They conclude with a discussion of the need for further research about how best...

  8. Exploring the experiences of novice clinical instructors in physical therapy clinical education: a phenomenological study. (United States)

    Greenfield, B H; Bridges, P H; Phillips, T A; Drill, A N; Gaydosik, C D; Krishnan, A; Yandziak, H J


    To explore the perceptions of novice physical therapy clinical instructors (CIs) about their interactions and teaching behaviours with physical therapy students. A phenomenological approach using semi-structured interviews and a focus group. Six novice physical therapy CIs (less than two years as a CI and supervised fewer than three students) were recruited purposefully from a large metropolitan area in the USA. All participants were credentialed by the American Physical Therapy Association as CIs. Transcripts of interview data and focus group data were analysed using interpretative analysis for themes and subthemes. Participants viewed the transition of students from the classroom to the clinic as their primary role, using strategies of 'providing a way in', 'fostering critical thinking', 'finding a balance', 'overcoming barriers' and 'letting go'. While novice CIs showed skill in fostering student reflection and providing orientation, they struggled with student autonomy and balancing the competing obligations of patient care and clinical instruction. They expressed issues related to anxiety and lack of confidence. In the future, novice CIs could benefit from training and support in these areas. Copyright © 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  9. Thinking Like Researchers: Action Research and Its Impact on Novice Teachers' Thinking (United States)

    Davis, Janine; Clayton, Courtney; Broome, John


    This project investigated the effects of novice teachers' responses to an action research project conducting during the student-teaching semester. This study drew on a framework that considered the participants' process of research, practice of teaching, and identity as a researcher and utilized a qualitative, multiple case-study approach with an…

  10. A Mixed Methods Survey Research Study of Novice Special Education Teachers: Investigation of Reading Preparedness (United States)

    Stratton, Mary P.


    Novice special education teachers have become an integral part of the public and private school systems throughout Pennsylvania. This mixed-methods research study explored the expertise and preparedness of current novice special education teachers. A combination of an electronic survey questionnaire and phone and face-to-face interviews were…

  11. Plagiarism: Misconduct Awareness on Novice Research within the ...

    African Journals Online (AJOL)

    More often than not, there exists some form of infringement relating to the use of other authors' work. This is particularly so in instances in which novice authors make use of the information available within the cyber-digital environment. The article explains the meaning of plagiarism and describes the many manifestations ...

  12. Clinical decision making of experienced and novice nurses. (United States)

    Tabak, N; Bar-Tal, Y; Cohen-Mansfield, J


    Decision making is an important daily nursing activity. Given contradictory past findings concerning the ease of use cognitive schema for reaching decisions among experts and novices, we chose to examine consistency of information as a parameter that may clarify the process of decision making. Ninety-two experienced nurses and 65 nursing students rated their decisional difficulty and levels of certainty in reaching a diagnosis for two scenarios: one including consistent information and one providing information that was partly inconsistent with the given diagnosis. For the consistent information, students showed more difficulty and less certainty in the given diagnosis than the experienced nurses. The inconsistent scenario was perceived as more difficult by nurses in comparison to students. The cognitive processes responsible for these results are discussed.

  13. Novice Supervisors' Practices and Dilemmatic Space in Supervision of Student Research Projects (United States)

    Vereijken, Mayke W. C.; van der Rijst, Roeland M.; van Driel, Jan H.; Dekker, Friedo W.


    Growing interest in student research projects in higher education has led to an emphasis on research supervision. We focus in this study on novice supervisors' approaches to research supervision as they explore their practices and experience difficulties supervising medical-students. Teacher noticing was used as a sensitising concept and relations…

  14. Librarian as Advisor: Information Search Process of Undecided Students and Novice Researchers (United States)

    Wiley, Claire; Williams, Judy


    Faculty librarians who advise undecided students have found the experiences of novice researcher and advisee comparable: Both groups seek to solve a problem or answer a question by finding new information to add to their current understanding and knowledge base. As a result, librarians familiar with needs and stages of the research process may…

  15. Clinical and Laboratory Characteristics of a Tinea Capitis Outbreak Among Novice Buddhist Monks. (United States)

    Bunyaratavej, Sumanas; Leeyaphan, Charussri; Rujitharanawong, Chuda; Muanprasat, Chanai; Matthapan, Lalita


    Sixty novice Buddhist monks with tinea capitis confirmed according to clinical presentation and mycological laboratory finding were included in this study. Mixed-type clinical presentation was observed in approximately half of all cases, together with scarring alopecia (95%) and superficial fungal skin infection at locations other than the scalp (43.3%). The major isolated organism was Trichophyton violaceum, and mixed-organism infection was found in 27 cases (45%). Slow-onset presentation and an extensive area of infection were significantly associated with mixed-type clinical presentation. © 2017 Wiley Periodicals, Inc.

  16. Accuracy of intuition in clinical decision-making among novice clinicians. (United States)

    Price, Amanda; Zulkosky, Kristen; White, Krista; Pretz, Jean


    To assess the reliance on intuitive and analytical approaches during clinical decision-making among novice clinicians and whether that reliance is associated with accurate decision-making. Nurse educators and managers tend to emphasize analysis over intuition during clinical decision-making though nurses typically report some reliance on intuition in their practice. We hypothesized that under certain conditions, reliance on intuition would support accurate decision-making, even among novices. This study utilized an experimental design with clinical complication (familiar vs. novel) and decision phase (cue acquisition, diagnosis and action) as within-subjects' factors, and simulation role (observer, family, auxiliary nurse and primary nurse) as between-subjects' factor. We examined clinical decision-making accuracy among final semester pre-licensure nursing students in a simulation experience. Students recorded their reasoning about emerging clinical complications with their patient during two distinct points in the simulation; one point involved a familiar complication and the other a relatively novel complication. All data were collected during Spring 2015. Although most participants relied more heavily on analysis than on intuition, use of intuition during the familiar complication was associated with more accurate decision-making, particularly in guiding attention to relevant cues. With the novel complication, use of intuition appeared to hamper decision-making, particularly for those in an observer role. Novice clinicians should be supported by educators and nurse managers to note when their intuitions are likely to be valid. Our findings emphasize the integrated nature of intuition and analysis in clinical decision-making. © 2016 John Wiley & Sons Ltd.

  17. Clinical Research

    DEFF Research Database (Denmark)

    Christensen, Irene


    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....

  18. How to survive in research: advice for the novice investigator. (United States)

    Siskind, Dan; Parker, Stephen; Loi, Samantha; Looi, Jeffrey C; Macfarlane, Matthew D; Merry, Sally; Smith, Geoff; Kisely, Steve


    This paper, written by the RANZCP Committee for Research, provides an outline for how to survive in research, considering the ingredients likely to contribute to success, the role of supportive structures and the expected challenges. Learning how to survive in research is relevant for both trainees and for Fellows undertaking research at any stage of their career. Intellectual curiosity, perseverance, frustration tolerance, patience and humility are key for success as a researcher. Selection of the right supervisor is important, as is development and maintenance of a good working supervisor/supervisee relationship. The personal benefits of undertaking research include flexibility in work hours, and improved skills in writing, oral presentations, objectivity, critical thinking, problem solving and project management. © The Royal Australian and New Zealand College of Psychiatrists 2014.

  19. Career Plans of Novice University Teachers: The Research Perspective

    Directory of Open Access Journals (Sweden)

    Wiegerová Adriana


    Full Text Available Introduction: The career trajectories of young university teachers have been a relatively frequent research target in North American and Western European countries but an entirely neglected topic of the Czech and Slovak educational research. This paper’s ambition is to narrow the gap. The research goal is to describe one aspect of career advancement of young university teachers - their professional plans after their entry to an academic position at a university after completion of their doctoral studies.

  20. Top tips for PhD thesis examination: nurse clinicians, researchers and novices. (United States)

    Cleary, Michelle; Horsfall, Jan; Hunt, Glenn E


    Interestingly, there are very few guidelines in the literature to assist novice nurse PhD examiners. In this paper, we aim to provide information to nurses, researchers or early career academics who have little experience in assessing a university thesis. The article provides background information about recent changes in the university sector; overviews some research on experienced examiners views; presents factors that differentiate between high and low quality PhD theses; and outlines some pointers that may be useful when marking at the doctoral level. Copyright © 2011 Elsevier Ltd. All rights reserved.

  1. Mapping the Ethnographic Journey: A "Road Map" for Novice Researchers Wanting to Engage in Ethnography, Critical Theory and Policy Analysis (United States)

    Naidu, Sham


    In this article, the "researcher" narrates the issues faced by novice researchers in choosing the correct lenses to conduct research when searching for the truth via the use of qualitative methodology. It is argued that choosing an appropriate research approach and methodology can be described as an "arduous" journey. For the…

  2. The Benefits of Multi-Year Research Experiences: Differences in Novice and Experienced Students’ Reported Gains from Undergraduate Research (United States)

    Thiry, Heather; Weston, Timothy J.; Laursen, Sandra L.; Hunter, Anne-Barrie


    This mixed-methods study explores differences in novice and experienced undergraduate students’ perceptions of their cognitive, personal, and professional gains from engaging in scientific research. The study was conducted in four different undergraduate research (UR) programs at two research-extensive universities; three of these programs had a focus on the biosciences. Seventy-three entry-level and experienced student researchers participated in in-depth, semi-structured interviews and completed the quantitative Undergraduate Research Student Self-Assessment (URSSA) instrument. Interviews and surveys assessed students’ developmental outcomes from engaging in UR. Experienced students reported distinct personal, professional, and cognitive outcomes relative to their novice peers, including a more sophisticated understanding of the process of scientific research. Students also described the trajectories by which they developed not only the intellectual skills necessary to advance in science, but also the behaviors and temperament necessary to be a scientist. The findings suggest that students benefit from multi-year UR experiences. Implications for UR program design, advising practices, and funding structures are discussed. PMID:22949423

  3. Review of research to inform the development of a hazard perception test for novice drivers in South Africa

    CSIR Research Space (South Africa)

    Venter, Karien


    Full Text Available that may be present. The ability to respond appropriately to hazards is a direct consequence of this awareness. Research has shown that awareness skills are largely lacking in novice drivers primarily due to their inexperience: hazard perception skills...

  4. Online Communication Settings and the Qualitative Research Process: Acclimating Students and Novice Researchers. (United States)

    Gregory, Katherine


    In the last 20 years, qualitative research scholars have begun to interrogate methodological and analytic issues concerning online research settings as both data sources and instruments for digital methods. This article examines the adaptation of parts of a qualitative research curriculum for understanding online communication settings. I propose methodological best practices for researchers and educators that I developed while teaching research methods to undergraduate and graduate students across disciplinary departments and discuss obstacles faced during my own research while gathering data from online sources. This article confronts issues concerning the disembodied aspects of applying what in practice should be rooted in a humanistic inquiry. Furthermore, as some approaches to online qualitative research as a digital method grow increasingly problematic with the development of new data mining technologies, I will also briefly touch upon borderline ethical practices involving data-scraping-based qualitative research.

  5. Novice Mathematics Teachers Create Themselves (United States)

    Schatz Oppenheimer, Orna; Dvir, Nurit


    This study presents a qualitative research based on three narratives written by novice mathematics teachers. We examine their unique professional world during their first year of work. The methodology of narrative framework, on which this article is based, helps to gain better understanding of the need for novice mathematics teachers to have…

  6. Research Areas - Clinical Trials (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.

  7. Clinical research informatics

    CERN Document Server

    Richesson, Rachel L


    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

  8. Reflections on Clinical Learning in Novice Speech-Language Therapy Students (United States)

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


    Background: Reflective practice is reported to enhance clinical reasoning and therefore to maximize client outcomes. The inclusion of targeted reflective practice in academic programmes in speech-language therapy has not been consistent, although providing opportunities for speech-language therapy students to reflect during their clinical practice…

  9. New graduate nurse transition programs and clinical leadership skills in novice RNs. (United States)

    Chappell, Kathy B; Richards, Kathy C; Barnett, Scott D


    The objective of this study was to determine predictors of clinical leadership skill (CLS) for RNs with 24 months of clinical experience or less. New graduate nurse transition programs (NGNTPs) have been proposed as a strategy to increase CLS. CLS is associated with positive patient outcomes. Method used was hierarchical regression modeling to evaluate predictors of CLS among individual characteristics of RNs and characteristics of NGNTPs. Perceived overall quality of an NGNTP was the strongest predictor of CLS (R = 0.041, P < .01). Clinical experience and NGNTP characteristics accounted for 6.9% of the variance in CLS and 12.6% of the variance among RNs with assigned mentors (P < .01). RNs participating in NGNTPs for more than 24 weeks were 21 times more likely to remain employed within the organization when compared with NGNTPs of 12 weeks or less, a significant cost-benefit to the organization. Although perceived overall quality of a NGNTP was the strongest predictor of CLS, much of the variance in CLS remains unexplained.

  10. Theory Ain't Practice: Four Novice Researchers Navigate Dilemmas of Representation within Immigrant Populations (United States)

    Aleixo, Marina; Hansen, Sarah; Horii, Sachiko; Un, Silvy


    This article illuminates instances in which four graduate students have struggled with issues of representation--of themselves and of immigrant participants--at their research sites and in their writing. These dilemmas are situated within the literature on the politics of representation in qualitative research. Although these dilemmas are not…

  11. Socialization of Novice Teachers (United States)

    Pogodzinski, Ben


    Guided by new structuralism theory, this study examined the context of novice teacher socialization, identified the frequency and substance of interactions between novice teachers and their mentors and other colleagues, and reported on novices' evaluation of the support that they received. Data were collected through semistructured interviews with…

  12. A call to improve sampling methodology and reporting in young novice driver research. (United States)

    Scott-Parker, B; Senserrick, T


    Young drivers continue to be over-represented in road crash fatalities despite a multitude of research, communication and intervention. Evidence-based improvement depends to a great extent upon research methodology quality and its reporting, with known limitations in the peer-review process. The aim of the current research was to review the scope of research methodologies applied in 'young driver' and 'teen driver' research and their reporting in four peer-review journals in the field between January 2006 and December 2013. In total, 806 articles were identified and assessed. Reporting omissions included participant gender (11% of papers), response rates (49%), retention rates (39%) and information regarding incentives (44%). Greater breadth and specific improvements in study designs and reporting are thereby identified as a means to further advance the field. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

  13. Publishing Not Perishing: How Research Students Transition from Novice to Knowledgeable Using Systematic Quantitative Literature Reviews (United States)

    Pickering, Catherine; Grignon, Julien; Steven, Rochelle; Guitart, Daniela; Byrne, Jason


    Current understandings suggest that three aspects of writing practice underpin the research student publication process: knowledge creation, text production and identity formation. Publishing a literature review is the first opportunity most students have to publish. This article compares the pedagogical benefits of different literature review…

  14. Human Securitability: A Participatory Action Research Study Involving Novice Teachers and Youngsters (United States)

    Kravale-Paulina, Marite; Olehnovica, Eridiana


    Civic participation, initiative and interest in current events can bridge the alienation felt towards national and municipal institutions, thereby enabling individuals to improve their quality of life and contribute to all-round sustainable development of their resident state. This paper reports on a participatory action research study into civic…

  15. Designing Internet Learning for Novice Users -Paper Based on a Action Research Project In India

    DEFF Research Database (Denmark)

    Purushothaman, Aparna


    The paper centre on an Action Research project undertaken in India for enabling the female students empowered through Internet use. The paper will discuss the design elements of Internet training for the first time users with limited Internet access based on Blooms Digital Taxonomy of Learning...... Domains.The paper also illustrates the identity formation of students, through learning to use Internet, using wengers social theory of learning with the empirical data....

  16. A Learning Partnership: Exploring Preceptorship through Interviews with Registered and Novice Nurses (United States)

    Ockerby, Cherene M.; Newton, Jennifer M.; Cross, Wendy M.; Jolly, Brian C.


    Novice nurses encounter numerous factors that impact on their learning in the complex healthcare workplace. Registered nurses often work one-on-one with novices as preceptors to facilitate the development of novices' clinical skills and socialisation into the profession. This paper explores the concept of preceptorship from novice nurses' and…

  17. Clinical Research and Clinical Trials (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, ...

  18. Research ethics for clinical researchers. (United States)

    Harnett, John D; Neuman, Richard


    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.

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

    LENUS (Irish Health Repository)

    Condell, Sarah L


    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.

  20. The Impact of an Interactive Statistics Module on Novices' Development of Scientific Process Skills and Attitudes in a First-Semester Research Foundations Course. (United States)

    Marsan, Lynnsay A; D'Arcy, Christina E; Olimpo, Jeffrey T


    Evidence suggests that incorporating quantitative reasoning exercises into existent curricular frameworks within the science, technology, engineering, and mathematics (STEM) disciplines is essential for novices' development of conceptual understanding and process skills in these domains. Despite this being the case, such studies acknowledge that students often experience difficulty in applying mathematics in the context of scientific problems. To address this concern, the present study sought to explore the impact of active demonstrations and critical reading exercises on novices' comprehension of basic statistical concepts, including hypothesis testing, experimental design, and interpretation of research findings. Students first engaged in a highly interactive height activity that served to intuitively illustrate normal distribution, mean, standard deviation, and sample selection criteria. To enforce practical applications of standard deviation and p -value, student teams were subsequently assigned a figure from a peer-reviewed primary research article and instructed to evaluate the trustworthiness of the data. At the conclusion of this exercise, students presented their evaluations to the class for open discussion and commentary. Quantitative assessment of pre- and post-module survey data indicated a statistically significant increase both in students' scientific reasoning and process skills and in their self-reported confidence in understanding the statistical concepts presented in the module. Furthermore, data indicated that the majority of students (>85%) found the module both interesting and helpful in nature. Future studies will seek to develop additional, novel exercises within this area and to evaluate the impact of such modules across a variety of STEM and non-STEM contexts.

  1. Fostering clinical reasoning in physiotherapy: comparing the effects of concept map study and concept map completion after example study in novice and advanced learners. (United States)

    Montpetit-Tourangeau, Katherine; Dyer, Joseph-Omer; Hudon, Anne; Windsor, Monica; Charlin, Bernard; Mamede, Sílvia; van Gog, Tamara


    Health profession learners can foster clinical reasoning by studying worked examples presenting fully worked out solutions to a clinical problem. It is possible to improve the learning effect of these worked examples by combining them with other learning activities based on concept maps. This study investigated which combinaison of activities, worked examples study with concept map completion or worked examples study with concept map study, fosters more meaningful learning of intervention knowledge in physiotherapy students. Moreover, this study compared the learning effects of these learning activity combinations between novice and advanced learners. Sixty-one second-year physiotherapy students participated in the study which included a pre-test phase, a 130-min guided-learning phase and a four-week self-study phase. During the guided and self-study learning sessions, participants had to study three written worked examples presenting the clinical reasoning for selecting electrotherapeutic currents to treat patients with motor deficits. After each example, participants engaged in either concept map completion or concept map study depending on which learning condition they were randomly allocated to. Students participated in an immediate post-test at the end of the guided-learning phase and a delayed post-test at the end of the self-study phase. Post-tests assessed the understanding of principles governing the domain of knowledge to be learned (conceptual knowledge) and the ability to solve new problems that have similar (i.e., near transfer) or different (i.e., far transfer) solution rationales as problems previously studied in the examples. Learners engaged in concept map completion outperformed those engaged in concept map study on near transfer (p = .010) and far transfer (p concept map completion led to greater transfer performance than worked examples study combined with concept map study for both novice and advanced learners. Concept map completion

  2. Everybody's Problem: Novice Teachers in Disadvantaged Mexican Schools (United States)

    Martínez, Nora H.


    This paper explores the difficulties that novice teachers confront at two economically, socially, and academically disadvantaged schools in the state of Nuevo Leon, Mexico. The researchers employed the action research tradition. Problems were identified using participant observation during reflexive workshops conducted with novice teachers and…

  3. SPECIAL ARTICLE Clinical research

    African Journals Online (AJOL)

    tal and practical work done in the best laboratories'.' I have previously argued that the components of aca- ... whom he admired, said 'Sydenham was called "a man of many doubts" and therein lay the secret of his .... It is worthwhile remembering, young researcher, that the probability or 'P' value is only a statement of the.

  4. Education in Clinical Reasoning: An Experimental Study on Strategies to Foster Novice Medical Students’ Engagement in Learning Activities

    Directory of Open Access Journals (Sweden)

    Alexander Linsen


    Full Text Available Purpose: Clinical reasoning forms the interface between medical knowledge and medical practice. However, it is not clear how to organize education to foster the development of clinical reasoning. This study compared two strategies to teach clinical reasoning. Method: As part of a regular clinical reasoning course 333 students participated in a two-phase experiment. In the learning phase, participants were randomly assigned to either the conventional strategy (CS or the new strategy (NS. Participants in the CS solved a clinical case using a written description of a patient encounter and individual study. Participants assigned to the NS solved the same case using a video patient encounter and group discussion. One week later, all participants took the same diagnostic performance test. Performance on the diagnostic test and differences between the groups regarding their interest, cognitive engagement, appreciation of the educational activity, and time investment in self-study were analyzed. Results: There was no significant effect of teaching strategy on diagnostic performance (p = .23. Students in the NS condition showed more interest during the session (p = .003 and were more appreciative of the course when assigning an overall grade than the students in the CS condition (p<.001. The NS students reported having spent fewer hours studying the clinical case individually before the group session than the CS students (p<.001. Discussion: The NS resulted in more students’ involvement and higher appreciation of the learning activity compared to the CS. There was no difference in diagnostic accuracy, but the NS seems more efficient: to achieve the same performance, the NS students needed only half the preparation time before the learning session than the students working under the CS. This higher efficiency may be due to the benefits of small-group learning, but clarifying this finding requires further investigation. Keywords: Clinical reasoning

  5. Novice Teachers' Perspectives on Learning in Lesson Rehearsals in Second Language Teacher Preparation (United States)

    Troyan, Francis John; Peercy, Megan Madigan


    Although scholars working in core practices have put forth lesson rehearsals as central to novice teachers' learning and development, there is little work on how novice teachers experience rehearsals. This qualitative research investigated learning opportunities for novice teachers of language learners during rehearsals. The analysis examines two…

  6. Young novice drivers.

    NARCIS (Netherlands)


    In The Netherlands, young novice drivers (18-24 years of age) show a crash rate that is five times higher than that of experienced drivers (30-59 years of age). The rate of young males is even seven times as high. The main reasons are lack of driving experience and hazardous behaviour typical of

  7. Linking neuroscientific research on decision making to the educational context of novice students assigned to a multiple-choice scientific task involving common misconceptions about electrical circuits

    Directory of Open Access Journals (Sweden)

    Patrice ePotvin


    Full Text Available Functional magnetic resonance imaging was used to identify the brain-based mechanisms of uncertainty and certainty associated with answers to multiple-choice questions involving common misconceptions about electric circuits. Twenty-two (22 scientifically novice participants (humanities and arts college students were asked, in an fMRI study, whether or not they thought the light bulbs in images presenting electric circuits were lighted up correctly, and if they were certain or uncertain of their answers. When participants reported that they were unsure of their responses, analyses revealed significant activations in brain areas typically involved in uncertainty (anterior cingulate cortex, anterior insula cortex, and superior/dorsomedial frontal cortex and in the left middle/superior temporal lobe. Certainty was associated with large bilateral activations in the occipital and parietal regions usually involved in visuospatial processing. Correct-and-certain answers were associated with activations that suggest a stronger mobilization of visual attention resources when compared to incorrect-and-certain answers. These findings provide insights into brain-based mechanisms of uncertainty that are activated when common misconceptions, identified as such by science education research literature, interfere in decision making in a school-like task. We also discuss the implications of these results from an educational perspective.

  8. [Research activity in clinical biochemistry

    DEFF Research Database (Denmark)

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


    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......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....... 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...

  9. [Research activity in clinical biochemistry

    DEFF Research Database (Denmark)

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


    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...

  10. Visual research in clinical education. (United States)

    Bezemer, Jeff


    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

  11. Practice among Novice Change Agents in Schools (United States)

    Blossing, Ulf


    The aim of the article is to understand practice as negotiation of meaning among novice and internal change agents in school organisations. The research question is as follows: What themes of participation and reification/management occur among the change agents? The study was qualitative in design using the social learning theory of community of…

  12. MR spectroscopy in clinical research

    DEFF Research Database (Denmark)

    Henriksen, O


    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...


    Directory of Open Access Journals (Sweden)

    Līga Paula


    Full Text Available Entering teaching profession is considered as the most determining stage in a teacher’s professional life. The aim of this research is to explore opinions of novice teachers in Latvia about the role of mentoring in their professional socialization. The following research questions were defined: (1 what difficulties novice teachers faced during their in-service experience? (2 what support novice teachers needed when they started teaching? (3 what the role of mentoring in teachers’ professional socialization is? Qualitative research design was developed for the research. Empirical data were obtained during the focus group discussion with ten teachers representing Council of young teachers (in age below 35 of the Latvian Trade Union of Education and Science Employees, nine semi-structured interviews with novice teachers, and interview with a mentor. Novice teachers face teaching reality which often differs from perceptions about the profession developed during the studies at university. The research shows that teachers from the sample faced following challenges during their first years of in-service: establishing teacher’s authority and self-positioning as a teacher, time management, problems with discipline in a classroom, lack of skills to develop curriculum and lesson plans, difficulties in communication with parents. During socialization novice teachers learned their responsibilities and acquired specific knowledge; appropriate support such as mentoring reduced level of stress and uncertainty while novice teachers adapted to school during the period of transition from pre-service period to in-service period. In relation to mentoring, novice teachers expected that a mentor would introduce them to school traditions and internal rules and would advise on discipline in a classroom as well as would help to develop curriculum. Policy makers should focus on teachers’ support guidelines at national level, which would allow schools to ensure the

  14. NIH Clinical Research Trials and You (United States)

    ... Info Lines Health Services Locator 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 ...

  15. Engaging novice researchers in the process and culture of science using a "Pass-the-Problem" case strategy. (United States)

    White, Harold B; Usher, David C


    Undergraduates having their first research experience frequently have little idea of what to expect. Institutions offering summer research experiences attempt to address this issue through programs that introduce students to the process and culture of science. However, didactic approaches frequently bore students who prefer more interactive sessions. We describe a "Pass-the-Problem" case study approach that engages groups of students in useful discussions about the research environment they are entering. The cases presented here include keeping a thorough laboratory notebook, balancing laboratory and personal time demands, anxiety about formal presentations, unexpected federal regulatory inspection, working in a lab with limited funds, being used as a technician rather than a researcher, frustration with failed experiments, effects of promotion and tenure on laboratory atmosphere, the importance of reading the research literature, and questioning a career in science. These cases alert students to different situations they might encounter and stimulate discussion about how to deal with them. © 2015 The International Union of Biochemistry and Molecular Biology.

  16. [Research activity in clinical biochemistry]. (United States)

    Jørgensen, Henrik L; Larsen, Birger; Ingwersen, Peter; Rehfeld, Jens F


    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 control group from other medical specialities in Denmark. A list of all physicians registered in Denmark (23,127 persons) was drawn from the database "". Of these, 5,202 were generalists (not included) while 11,691 were from other specialities. Of the 126 specialists from 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. 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 compared to 51 for the control group. The number of citations per specialist was 1,844 for Clinical Biochemistry compared to 816 for the control group. The top ten H-indices (of which 8 were in Clinical Biochemistry) ranged from 30 to 69. Both the number of papers and the number of citations were higher for Clinical Biochemistry than for the control group. The difference was most pronounced among professors.

  17. Bias in clinical intervention research

    DEFF Research Database (Denmark)

    Gluud, Lise Lotte


    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...

  18. Novice supervisee's experiences of what is good and bad psychotherapy supervision

    DEFF Research Database (Denmark)

    Jacobsen, Claus Haugaard; Pedersen, Lene Tanggaard


    This paper presents a qualitative study of novice supervisee’s experiences of good and bad supervisory experiences and on how this change as the supervisees gain more experience. Novice psychotherapists rate supervision as the most important element in their acquisition of professional skills...... was conducted as a series of semi structured qualitative research interviews with 7 student therapist 2 month after their first clinical experience in a university clinic setting. The subjects were re-interviewed when they had almost a year of clinical experience and supervision. The interviews were...... thematically focusing on the experience of specific good and bad supervisory experiences. Also included were the importance of peers in the supervision group and the organisational setting of the supervision. After analysing each individuals experience all individual experiences were examined until patterns...

  19. Validated Measures of Publication Quality: Guide for Novice Researchers to Choose an Appropriate Journal for Paper Submission

    Directory of Open Access Journals (Sweden)

    Mohammad H. Ebrahimzadeh


    Full Text Available There is always a concern regarding the "quality" of publications as an index for promotion and career advancement. There are some ways to measure this "quality" including impact factor and SCImago Journal Rank (SJR as a measure of journals’ level of impact, h-index as a measure of researchers’ level of impact, and visibility and citation as a measure of individual papers’ level of impact. Paper publication is bringing revenue to some journals by soliciting money from whom that must publish or perish. This raises the suspicion of fraud toward Open Access journals because sometimes charlatans pocket the money via creating predatory journals or even creating counterfeit websites using terms similar to those already known. For this reason, legitimate Open Access journals have to be authenticated. Tempting emails from Open Access journals showing high indices of quality might entrap the new researchers, which could be prevented by awareness of the below terms [Figure 1]. ...

  20. The first year of practice: an investigation of the professional learning and development of promising novice physical therapists. (United States)

    Black, Lisa L; Jensen, Gail M; Mostrom, Elizabeth; Perkins, Jan; Ritzline, Pamela D; Hayward, Lorna; Blackmer, Betsy


    The goal in studying expertise is not merely to describe ways in which experts excel but also to understand how experts develop in order to better facilitate the development of novices. The study of novice progression helps us to understand what successful versus unsuccessful learning looks like. This understanding is critical, as autonomous practice places increased demands for advanced clinical judgments and the ability to assume professional responsibilities. The purpose of this study was to explore the experiences, learning, and development of promising novice therapists throughout their first year of practice in the United States. A longitudinal, multiple-site qualitative case study method was used for within-case and across-case analysis. A purposive sample of 11 promising new graduates from 4 physical therapist education programs participated. Investigators followed the graduates throughout their first year of practice. Data sources included: (1) semistructured interviews conducted at baseline and every 3 months thereafter for 1 year, (2) reflective journals completed at regular intervals, and (3) review of academic and clinical education records and résumés. Four themes emerged: (1) the clinical environment influenced the novice physical therapists' performance, (2) participants learned through experience and social interaction and learning was primarily directed toward self, (3) growing confidence was directly related to developing communication skills, and (4) therapists were engaged in professional identity formation and role transitions. The findings suggest there are common experiences and themes that emerge as novice physical therapists develop. Although research has been conducted on expertise in physical therapy, few longitudinal investigations have explored the development of therapists across transitions from graduate to novice to expert practitioner. This study explored and described the learning and development of graduates during their first

  1. Research and clinical practice relationship

    Directory of Open Access Journals (Sweden)

    Ashammakhi N


    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.

  2. Professional impact of clinical research

    Energy Technology Data Exchange (ETDEWEB)

    Nelhans, G.


    In this study, professional impact is defined as the academic literature that is cited in the literature that is used by professions in order to pursue skilled activities that are specific to their expertise. Specifically, we are focusing on the clinical guidelines that are used in the many health and medical professions that are issued by government bodies at national and international levels to ensure a certain quality level and to make results comparable at the national level. To date, more than 50.000 references have been identified in about 500 Swedish clinical guidelines issued by the above mentioned governmental bodies in Sweden. Of these, 73 % of the references have been matched to a PubMed id. The goal of this project is to develop a conceptual and theoretical contribution to the development of indicators for measuring the impact of research outside of the specifically academic literature. (Author)

  3. Professional Development of Novice Special Education Teachers

    Directory of Open Access Journals (Sweden)

    Silmara de Oliveira Gomes Papi


    Full Text Available The professional development of novice teachers in the profession and in special education is poorly understood, despite its relevance to the improvement of teaching. This study analyzes the challenges faced by such teachers with a view to understanding their professional development. The participants in the research were teachers of classrooms equipped with multifunctional resources (SRM in state schools. The research follows a critical-dialectic approach and a qualitative focus. The results indicate deficiencies in the professional development of novices, who experience difficulties related to teaching and bureaucracy, despite having specific training in the area. They also feel alienated in the schools and seek alternatives to fill existing gaps related to their professional practice.

  4. Heuristic Evaluation for Novice Programming Systems


    Kölling, Michael; McKay, Fraser


    The past few years has seen a proliferation of novice programming tools. The availability of a large number of systems has made it difficult for many users to choose among them. Even for education researchers, comparing the relative quality of these tools, or judging their respective suitability for a given context, is hard in many instances. For designers of such systems, assessing the respective quality of competing design decisions can be equally difficult.\\ud Heuristic evaluation provides...

  5. Clinical Epidemiology Unit - overview of research areas (United States)

    Clinical Epidemiology Unit (CEU) conducts etiologic research with potential clinical and public health applications, and leads studies evaluating population-based early detection and cancer prevention strategies

  6. Novice supervisors' tasks and training

    DEFF Research Database (Denmark)

    Nielsen, Jan; Jacobsen, Claus Haugaard; Mathiesen, Birgit Bork


    were confronted with complicated jobs, e.g., group, internal and interdisciplinary supervision, but were not prepared, i.e. trained, prior to these tasks. These findings imply that more training is needed for novice supervisors. Preferably, this training should be introduced before, or at least...... Questionnaire covering a wide range of items on professional development, experience, and practice. In this paper we focus on background data (experience, training and practice), specifically the tasks and training of the respondents as novice supervisors. The results show, that a majority of novice supervisors...

  7. Developing resilience: Stories from novice nurse academics. (United States)

    McDermid, Fiona; Peters, Kath; Daly, John; Jackson, Debra


    It is acknowledged that novice nurse academics face many challenges on commencement of their new role. Most are recruited from the clinical arena, with little understanding of the academic triumvirate of teaching, research and service. They struggle with role expectation and experience feelings of isolation and anxiety. The aim of this paper is to report on an exploration of 14 new nurse academics from two major nursing education institutions as they utilised and developed resilience building strategies. The paper is drawn from a qualitative study that sought to see the world through the eyes of the participants through storytelling. Data was collected using semi-structured, conversational style interviews. Interviews were audio recorded and revealed themes that captured resilience strategies. These themes were: Developing supportive collegial relationships; Embracing positivity; and Reflection and transformative growth. The first theme, developing supportive relationships, provides insight into the mentoring process and the relationships developed with peers and colleagues. The second theme, embracing positivity, describes the factors that assisted them to face the adversity and challenges in the new role. The final theme, reflection and transformative growth, demonstrated participants' reflecting on difficult situations and demonstrating the ability to learn from the experiences and move forward. The strategies utilised by the participants in this study were key factors in the development of resilience which assisted in the transition from clinical nurse to academic. These strategies were often tacit and it is imperative that in a time of acute nurse academic shortages where retention is paramount, that employing organisations support employees and contribute to resilience development. Education on resilience building strategies is fundamental for all new academics and is essential in the transition from clinical nurse to academic. Crown Copyright © 2016

  8. Be a Partner in Clinical Research (United States)

    ... 2015 Print this issue Be a Partner in Clinical Research Help Others, Help Yourself En español Send us ... Did you know that you can participate in clinical research? Whether you’re healthy or sick, young or ...

  9. Stuttering: Clinical and research update. (United States)

    Perez, Hector R; Stoeckle, James H


    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.

  10. Ethics in clinical research: The Indian perspective


    J Sanmukhani; C B Tripathi


    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 Organiza...

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


    C. A. Caramori


    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 c...

  12. Preparedness for physiotherapy in private practice: Novices identify key factors in an interpretive description study. (United States)

    Atkinson, Robyn; McElroy, Theresa


    Physiotherapists in Australia deliver services to a diverse range of clients, across many settings, however little research exists examining graduate preparedness for practice, even in the populous field of private practice. To explore novice physiotherapist perspectives on preparedness for work in private practice. The qualitative approach of interpretive description was used to guide in-depth interviews with 8 novice physiotherapists from 3 universities working in 5 private practices in Melbourne. All interviews were digitally recorded, transcribed verbatim and analyzed thematically. Four main themes influencing graduate preparedness for work in private practice were identified: 1) non-curricular experiences (e.g. sports training) 2) elective curricular: practicum experiences; 3) curricular: attainment of skills specific to private practice; and 4) the private practice setting: supportive colleagues. This combination of non-curricular, curricular, and practice setting factors offered the necessary scaffolding for the graduates to report feeling prepared for work in private practice. Non-curricular activities, radiological instruction, clinical placements, building supportive colleague relations and professional development in private practice are recommended as potential means of building preparedness in novice therapists. Findings have implications for physiotherapy students, educators and private practice clinics looking to recruit new graduates. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Administrative support of novice science teachers: A multiple case study (United States)

    Iacuone, Leann

    Novice science teachers leave the confines of colleges and universities to embark on a new adventure in education where they aim to influence young minds, make a difference in the world, and share their love for their content. They have learned their pedagogical skills with the support and assistance of fellow classmates, a supporting professor, and a cooperating teacher. These teachers enter their new place of employment and are met with many unexpected challenges, such as a lack of resources, no one to ask questions of, and a busy staff with already established relationships, causing them to feel an overall lack of support and resulting in many new teachers rethinking their career choice and leaving the field of education within 5 years of entering. This multiple-case study investigated the administrative support 4 novice science teachers received during an academic year and the novice teachers' perceptions of the support they received to answer the following research question: How do novice science teachers who have consistent interactions with administrators develop during their first year? To answer this question, semistructured interviews, reflection journals, observations, resumes, long-range plans, and student discipline referrals were collected. The findings from this study show novice science teachers who had incidents occur in the classroom requiring administrative assistance and guidance felt more confident in enforcing their classroom management policies and procedures as the year progressed to change student behavior. The novice science teachers perceived administrators who provided resources including technology, office supplies, science supplies, and the guidance of a mentor as supportive. Novice science teachers who engaged in dialogue after administrative observations, were provided the opportunity to attend professional development outside the district, and had a mentor who taught the same discipline made more changes to their instructional

  14. The changing landscape for clinical research. (United States)

    Heinig, S J; Quon, A S; Meyer, R E; Korn, D


    The authors review the history of U.S. clinical research and identify the profound changes stemming from advancements in the biomedical sciences, the recent transformation in the organization and financing of health care delivery, and the increasing application of information technologies. They observe that the enterprise must reorganize to account for the changed landscape, but there is a lack of the data necessary to monitor change and determine the extent to which clinical research is successfully realigning and sustaining itself. The authors discuss the evolving definition, scope, and venues for clinical research, and review previous analyses of clinical research's difficulties and remedies proposed: shared responsibility in the financing of academic medicine, support by federal and private health insurers for routine costs of patient care in clinical trials, and strengthened collaboration between and among industry, academia, insurers, and government. The authors conclude by describing two major initiatives to foster clinical investigation in the new landscape. The first is the Clinical Research Summit Project, a convocation of representative stakeholders from the health care system with an interest in clinical research, whose charge will be to formulate a national agenda for clinical research that has the broad-based support of the stakeholders. Among the challenges of this undertaking are the needs to identify new and stable sources of support for clinical research infrastructure, assess the future workforce needs for clinical investigation, and devise new methods to ensure the continued vitality and account-ability of clinical research. The second is the Clinical Research Task Force, an initiative of the Association of American Medical Colleges (AAMC), which is already exploring and advising on how AAMC member organizations can best strengthen their capacity to support clinical research programs in the current scientific, health care delivery, and financial

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

    Directory of Open Access Journals (Sweden)

    C. A. Caramori


    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 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.

  16. Snapchat media retrieval for novice device users

    CSIR Research Space (South Africa)

    Khan, ZC


    Full Text Available procedures that are easily enough for novice smartphone users to employ: not necessarily hackers or information security specialists, but an average smartphone user. The results indicate that, it is indeed possible for novices to retrieve Snapchat data...

  17. Infectious Disease Clinical Research Program (IDCRP) (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...

  18. Research leadership: should clinical directors be distinguished researchers? (United States)

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


    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.

  19. Improvement of Clinical Skills through Pharmaceutical Education and Clinical Research. (United States)

    Ishizaki, Junko


    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.

  20. Modern Clinical Research on LSD


    Liechti, Matthias E.


    All modern clinical studies using the classic hallucinogen lysergic acid diethylamide (LSD) in healthy subjects or patients in the last 25 years are reviewed herein. There were five recent studies in healthy participants and one in patients. In a controlled setting, LSD acutely induced bliss, audiovisual synesthesia, altered meaning of perceptions, derealization, depersonalization, and mystical experiences. These subjective effects of LSD were mediated by the 5-HT2A receptor. LSD increased fe...

  1. The importance of Clinical Research

    Directory of Open Access Journals (Sweden)

    Frank Lizaraso Caparó


    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. Using Simulation to Support Novice Teachers' Classroom Management Skills: Comparing Traditional and Alternative Certification Groups (United States)

    Pankowski, Jennifer; Walker, Joan T.


    Drawing from research on situated cognition and the development of expertise and simulations in professional education, we designed two simulation tasks that provided novice teachers with repeated opportunities to deliberately practice managing a classroom under no-fault conditions. The simulations immersed novices in two perennial classroom…

  3. Tracking Professional Development of Novice Teachers When Integrating Technology in Teaching Mathematics (United States)

    Gurevich, Irina; Stein, Hana; Gorev, Dvora


    This research traced changes in choices of technological tools and attitudes toward technology use among novice mathematics teachers at three stages of their professional development: as pre-service teachers, a year later, and in their work as novice teachers. At each stage, the participants were required to evaluate the benefits of technology use…

  4. Instructional Leadership Challenges and Practices of Novice Principals in Rural Schools (United States)

    Wiezorek, Douglas; Manard, Carolyn


    We report on a phenomenological study of the leadership experiences of six novice, rural public school principals in a midwestern U.S. state. We situated our analysis within existing research on leadership for learning, particularly how novice principals interpreted instructional leadership challenges in the context of rural school leadership. Our…

  5. Database on veterinary clinical research in homeopathy. (United States)

    Clausen, Jürgen; Albrecht, Henning


    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' ( 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.

  6. The Development of Novice Teachers' Culturally Responsive Classroom Management Practice (United States)

    Patish, Yelena


    While extensive research has been conducted on classroom management little research exists on culturally responsive classroom management. The primary purpose of this qualitative study was to examine how four novice teachers developed their culturally responsive management practice (CRCM) to better meet the needs of their students. My analysis was…

  7. Chloracne: From clinic to research

    Directory of Open Access Journals (Sweden)

    Qiang Ju


    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.

  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. Nuclear medical approaches to clinical research

    International Nuclear Information System (INIS)

    Otte, Andreas; Nguyen, Tristan


    In the frame of the master course Clinical research management at the scientific college Lahr in cooperation with the Albert-Ludwigs-University Freiburg three contributions are presented: Functional imaging - supported clinical studies in the sleep research. A comparison of NMR imaging versus SPECT and PET (advantages and disadvantages). Clinical studies with ionizing radiation and the radiation fear of the public. The new radioimmunotherapeutic agent Zevalin and the challenges at the market.

  10. Blockchain technology for improving clinical research quality


    Benchoufi, Mehdi; Ravaud, Philippe


    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 transpar...

  11. Modern Clinical Research on LSD. (United States)

    Liechti, Matthias E


    All modern clinical studies using the classic hallucinogen lysergic acid diethylamide (LSD) in healthy subjects or patients in the last 25 years are reviewed herein. There were five recent studies in healthy participants and one in patients. In a controlled setting, LSD acutely induced bliss, audiovisual synesthesia, altered meaning of perceptions, derealization, depersonalization, and mystical experiences. These subjective effects of LSD were mediated by the 5-HT 2A receptor. LSD increased feelings of closeness to others, openness, trust, and suggestibility. LSD impaired the recognition of sad and fearful faces, reduced left amygdala reactivity to fearful faces, and enhanced emotional empathy. LSD increased the emotional response to music and the meaning of music. LSD acutely produced deficits in sensorimotor gating, similar to observations in schizophrenia. LSD had weak autonomic stimulant effects and elevated plasma cortisol, prolactin, and oxytocin levels. Resting-state functional magnetic resonance studies showed that LSD acutely reduced the integrity of functional brain networks and increased connectivity between networks that normally are more dissociated. LSD increased functional thalamocortical connectivity and functional connectivity of the primary visual cortex with other brain areas. The latter effect was correlated with subjective hallucinations. LSD acutely induced global increases in brain entropy that were associated with greater trait openness 14 days later. In patients with anxiety associated with life-threatening disease, anxiety was reduced for 2 months after two doses of LSD. In medical settings, no complications of LSD administration were observed. These data should contribute to further investigations of the therapeutic potential of LSD in psychiatry.

  12. Leveraging electronic health records for clinical research. (United States)

    Raman, Sudha R; Curtis, Lesley H; Temple, Robert; Andersson, Tomas; Ezekowitz, Justin; Ford, Ian; James, Stefan; Marsolo, Keith; Mirhaji, Parsa; Rocca, Mitra; Rothman, Russell L; Sethuraman, Barathi; Stockbridge, Norman; Terry, Sharon; Wasserman, Scott M; Peterson, Eric D; Hernandez, Adrian F


    Electronic health records (EHRs) can be a major tool in the quest to decrease costs and timelines of clinical trial research, generate better evidence for clinical decision making, and advance health care. Over the past decade, EHRs have increasingly offered opportunities to speed up, streamline, and enhance clinical research. EHRs offer a wide range of possible uses in clinical trials, including assisting with prestudy feasibility assessment, patient recruitment, and data capture in care delivery. To fully appreciate these opportunities, health care stakeholders must come together to face critical challenges in leveraging EHR data, including data quality/completeness, information security, stakeholder engagement, and increasing the scale of research infrastructure and related governance. Leaders from academia, government, industry, and professional societies representing patient, provider, researcher, industry, and regulator perspectives convened the Leveraging EHR for Clinical Research Now! Think Tank in Washington, DC (February 18-19, 2016), to identify barriers to using EHRs in clinical research and to generate potential solutions. Think tank members identified a broad range of issues surrounding the use of EHRs in research and proposed a variety of solutions. Recognizing the challenges, the participants identified the urgent need to look more deeply at previous efforts to use these data, share lessons learned, and develop a multidisciplinary agenda for best practices for using EHRs in clinical research. We report the proceedings from this think tank meeting in the following paper. Copyright © 2018 Elsevier, Inc. All rights reserved.

  13. Translational Bioinformatics and Clinical Research (Biomedical) Informatics. (United States)

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


    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.

  14. Retooling Institutional Support Infrastructure for Clinical Research (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


    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 detract 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 transition to unified research support. PMID:27125563

  15. CLARA: an integrated clinical research administration system (United States)

    Bian, Jiang; Xie, Mengjun; Hogan, William; Hutchins, Laura; Topaloglu, Umit; Lane, Cheryl; Holland, Jennifer; Wells, Thomas


    Administration of human subject research is complex, involving not only the institutional review board but also many other regulatory and compliance entities within a research enterprise. Its efficiency has a direct and substantial impact on the conduct and management of clinical research. In this paper, we report on the Clinical Research Administration (CLARA) platform developed at the University of Arkansas for Medical Sciences. CLARA is a comprehensive web-based system that can streamline research administrative tasks such as submissions, reviews, and approval processes for both investigators and different review committees on a single integrated platform. CLARA not only helps investigators to meet regulatory requirements but also provides tools for managing other clinical research activities including budgeting, contracting, and participant schedule planning. PMID:24778201

  16. The Roles and Performance of Professional Driving Instructors in Novice Driver Education

    Directory of Open Access Journals (Sweden)

    Zulhaidi M. Jawi


    Full Text Available This review article aimed to analyse existing literature regarding the roles and performance of professional driving instructors (PDIs in novice driver education (DE. A systematic classification scheme was adopted to analyse identified articles to determine the study context of PDIs in novice DE, the competency level of PDIs in relation to experienced and learner drivers and the contributions of PDIs to the novice driver learning process. A total of 14 original research articles were identified, with no systematic reviews or meta-analyses available. Overall, all of the articles were found to be inadequate in providing an in-depth understanding of the roles and performance of PDIs in novice DE. There is an urgent need to improve current understanding of the roles of PDIs in novice DE and to work towards an internationally recognised PDI management approach.

  17. Novice in Secondary School--The Coin Has Two Sides (United States)

    Ulvik, Marit; Smith, Kari; Helleve, Ingrid


    The aim of this study is to gain an insight into novice teachers' diverse experiences. The study is conducted among nine beginning teachers in upper secondary school in Norway, and the research instrument was semi structured interviews. The main findings indicate that there are two sides of the coin of being a new teacher, positive as well as less…

  18. How Do Novice Art Teachers Define and Implement Meaningful Curriculum? (United States)

    Bain, Christina; Newton, Connie; Kuster, Deborah; Milbrandt, Melody


    Four researchers collaborated on this qualitative case study that examined 11 first-year novice art teachers' understanding and implementation of meaningful curriculum. Participants were selected through a criterion method sampling strategy; the subjects were employed in rural, urban, and suburban public school districts. In order to conduct a…

  19. Effects of a work-based critical reflection program for novice nurses. (United States)

    Kim, Yeon Hee; Min, Ja; Kim, Soon Hee; Shin, Sujin


    Critical reflection is effective in improving students' communication abilities and confidence. The aim of this study was to evaluate the effectiveness of a work-based critical reflection program to enhance novice nurses' clinical critical-thinking abilities, communication competency, and job performance. The present study used a quasi-experimental design. From October 2014 to August 2015, we collected data from 44 novice nurses working in an advanced general hospital in S city in Korea. Nurses in the experimental group participated in a critical reflection program for six months. Outcome variables were clinical critical-thinking skills, communication abilities, and job performance. A non-parametric Mann-Whitney U-test and a Wilcoxon rank sum test were selected to evaluate differences in mean ranks and to assess the null hypothesis that the medians were equal across the groups. The results showed that the clinical critical-thinking skills of those in the experimental group improved significantly (p = 0.003). The differences in mean ranks of communication ability between two groups was significantly statistically different (p = 0.028). Job performance improved significantly in both the experimental group and the control group, so there was no statistical difference (p = 0.294). We therefore suggest that a critical reflection program be considered an essential tool for improving critical thinking and communication abilities among novice nurses who need to adapt to the clinical environment as quickly as possible. Further, we suggest conducting research into critical reflection programs among larger and more diverse samples.

  20. Radiopharmacy - clinical reality and selected research demands

    International Nuclear Information System (INIS)

    Hoer, G.


    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)

  1. Conducting Clinical Research Using Crowdsourced Convenience Samples. (United States)

    Chandler, Jesse; Shapiro, Danielle


    Crowdsourcing has had a dramatic impact on the speed and scale at which scientific research can be conducted. Clinical scientists have particularly benefited from readily available research study participants and streamlined recruiting and payment systems afforded by Amazon Mechanical Turk (MTurk), a popular labor market for crowdsourcing workers. MTurk has been used in this capacity for more than five years. The popularity and novelty of the platform have spurred numerous methodological investigations, making it the most studied nonprobability sample available to researchers. This article summarizes what is known about MTurk sample composition and data quality with an emphasis on findings relevant to clinical psychological research. It then addresses methodological issues with using MTurk--many of which are common to other nonprobability samples but unfamiliar to clinical science researchers--and suggests concrete steps to avoid these issues or minimize their impact.

  2. Converging clinical and engineering research on neurorehabilitation

    CERN Document Server

    Torricelli, Diego; Pajaro, Marta


    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, 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...

  3. Challenging Transitions and Crossing Borders: Preparing Novice Mathematics Teacher Educators to Support Novice K-12 Mathematics Teachers (United States)

    Yow, Jan A.; Eli, Jennifer A.; Beisiegel, Mary; McCloskey, Andrea; Welder, Rachael M.


    Sixty-nine recently graduated doctoral students in mathematics education completed a survey to determine their perceptions of transitioning from a doctoral program into an academic position at an institution of higher education. Research literature for novice mathematics school teachers was also reviewed to document their experiences transitioning…

  4. Development and Validation of a Novice Teacher and Supervisor Survey (United States)

    Finster, Matthew


    This brief presents initial evidence about the reliability and validity of a novice teacher survey and a novice teacher supervisor survey. The novice teacher and novice teacher supervisor surveys assess how well prepared novice teachers are to meet the job requirements of teaching. The surveys are designed to provide educator preparation programs…

  5. Clinical trials: bringing research to the bedside. (United States)

    Arvay, C A


    Over the years, clinical trials with their structured treatment plans and multicenter involvement have been instrumental in developing new treatments and establishing standard of care therapy. While clinical trials strive to advance medical knowledge, they provide scientifically sound, state of the art care and their use should be increased. The Brain Tumor Cooperative Group, one such NCI-sponsored cooperative group, has been the primary group for the treatment of malignant gliomas. As the field of neuro-oncology expands, the neuroscience nurse needs to develop an understanding of clinical trials and their operation. The nurse is in an optimal position to support medical research and the research participant.

  6. Fostering clinical reasoning in physiotherapy: Comparing the effects of concept map study and concept map completion after example study in novice and advanced learners

    NARCIS (Netherlands)

    K. Montpetit-Tourangeau (Katherine); J.-O. Dyer (Joseph-Omer); A. Hudon (Anne); Windsor, M. (Monica); B. Charlin (Bernard); S. Mamede (Silvia); T. van Gog (Tamara)


    textabstractBackground: Health profession learners can foster clinical reasoning by studying worked examples presenting fully worked out solutions to a clinical problem. It is possible to improve the learning effect of these worked examples by combining them with other learning activities based on

  7. Fostering clinical reasoning in physiotherapy : Comparing the effects of concept map study and concept map completion after example study in novice and advanced learners

    NARCIS (Netherlands)

    Montpetit-tourangeau, Katherine; Dyer, Joseph-omer; Hudon, Anne; Windsor, Monica; Charlin, Bernard; Mamede, Sílvia; Van Gog, Tamara


    Background: Health profession learners can foster clinical reasoning by studying worked examples presenting fully worked out solutions to a clinical problem. It is possible to improve the learning effect of these worked examples by combining them with other learning activities based on concept maps.

  8. Research Issues in Clinical Data Warehousing

    DEFF Research Database (Denmark)

    Pedersen, Torben Bach; Jensen, Christian Søndergaard


    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...

  9. [Conflict of interests in clinical research]. (United States)

    Alves, Elaine Maria de Oliveira; Tubino, Paulo


    In clinical research there is a real possibility to have some conflict of interests. Even for the researcher, the identification of these conflicts cannot be clear. There are many aspects to be considered, involving all participants of the process: the research subject, the researcher, the institution where the research is carried through, the sponsor, the ethics committees, the regulating agencies, the scientific community and the society. The conclusion is that conflicts of interests are common and inevitable in the academic field. The challenge is not to eradicate them, but to recognize them and to manage them properly. The only acceptable way to do this is to expose clearly the conflicts of interests and always to submit the clinical research projects to the ethics committees.

  10. Transitioning from Clinical to Qualitative Research Interviewing

    Directory of Open Access Journals (Sweden)

    Matthew R. Hunt BSc (PT, PhD


    Full Text Available In this paper one aspect of the transition that must be made by experienced clinicians who become involved in conducting qualitative health research is examined, specifically, the differences between clinical and research interviewing. A clinician who is skillful and comfortable carrying out a clinical interview may not initially apprehend the important differences between these categories and contexts of interviewing. This situation can lead to difficulties and diminished quality of data collection because the purpose, techniques and orientation of a qualitative research interview are distinct from those of the clinical interview. Appreciation of these differences between interview contexts and genres, and strategies for addressing challenges associated with these differences, can help clinician researchers to become successful qualitative interviewers.

  11. The Clinical Research Landscape in Rhode Island. (United States)

    Mao, George; Ramratnam, Bharat


    To present an overview of clinical research activity and the state of medical research funding in Rhode Island. We utilized 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 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].

  12. Electronic health records to facilitate clinical research. (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


    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.

  13. Clinical outcomes research in gynecologic oncology. (United States)

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


    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.

  14. Public information about clinical trials and research. (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice


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

  15. Ethics in clinical research: the Indian perspective. (United States)

    Sanmukhani, J; Tripathi, C B


    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.

  16. Reorganizing the General Clinical Research Center to improve the clinical and translational research enterprise. (United States)

    Allen, David; Ripley, Elizabeth; Coe, Antoinette; Clore, John


    In 2010, Virginia Commonwealth University (VCU) was granted a Clinical and Translational Science Award which prompted reorganization and expansion of their clinical research infrastructure. A case study approach is used to describe the implementation of a business and cost recovery model for clinical and translational research and the transformation of VCU's General Clinical Research Center and Clinical Trials Office to a combined Clinical Research Services entity. We outline the use of a Plan, Do, Study, Act cycle that facilitated a thoughtful transition process, which included the identification of required changes and cost recovery processes for implementation. Through this process, the VCU Center for Clinical and Translational Research improved efficiency, increased revenue recovered, reduced costs, and brought a high level of fiscal responsibility through financial reporting.

  17. Clinical Research Informatics Contributions from 2015. (United States)

    Daniel, C; Choquet, R


    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

  18. Role perceptions of nurse clinical research coordinators

    Directory of Open Access Journals (Sweden)

    Jones CT


    Full Text Available Carolynn Thomas Jones, Lynda L Wilson School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA Abstract: Nursing roles in clinical research have evolved in the last 3 decades and include diverse responsibilities and job titles. Nurse clinical research coordinators’ (NCRCs roles include study planning, implementation, participant recruitment and retention, assessment of participants’ responses to clinical protocols, data management, and evaluation. The purpose of this study was to examine NCRCs’ perceptions of 59 specific clinical research activities that have been proposed as a taxonomy of NCRC activities. Participants were asked to check whether each of the 59 activities is being performed, and whether those activities should be performed, by NCRCs. The sample included 61 NCRCs who were attending the annual meeting of the International Association of Clinical Research Nurses. The percentage of respondents who indicated that the 59 activities are being performed by NCRCs at their sites ranged from 55%–98.4%. The percentage of respondents who indicated that the 59 activities should be performed by NCRCs ranged from 61.7%–88.5%. There were eight activities that fewer than 70% of the respondents reported should be performed by NCRCs. Chi-square analyses were conducted to determine whether there was a difference in the distribution of responses to the “are performed” versus “should be performed” responses for each of the 59 activities. There were significant differences in the distributions for 49 of the activities. The percentage of nurses responding “are performed” was higher than the percentage of responses to the “should be performed” items for 41 of these 49 activities. Findings suggest that further research is needed to validate the extent to which the taxonomy of clinical research nurse (CRN roles is a valid reflection of the actual practice of NCRCs, and also to explore reasons for the

  19. Electronic health records to facilitate clinical research


    Cowie, Martin R.; Blomster, Juuso I.; Curtis, Lesley H.; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, J?rg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P.; Southworth, Mary Ross; Stough, Wendy Gattis


    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 pr...

  20. CBT competence in novice therapists improves anxiety outcomes. (United States)

    Brown, Lily A; Craske, Michelle G; Glenn, Daniel E; Stein, Murray B; Sullivan, Greer; Sherbourne, Cathy; Bystritsky, Alexander; Welch, Stacy S; Campbell-Sills, Laura; Lang, Ariel; Roy-Byrne, Peter; Rose, Raphael D


    This study explores the relationships between therapist variables (cognitive behavioral therapy [CBT] competence, and CBT adherence) and clinical outcomes of computer-assisted CBT for anxiety disorders delivered by novice therapists in a primary care setting. Participants were recruited for a randomized controlled trial of evidence-based treatment, including computer-assisted CBT, versus treatment as usual. Therapists (anxiety clinical specialists; ACSs) were nonexpert clinicians, many of whom had no prior experience in delivering psychotherapy (and in particular, very little experience with CBT). Trained raters reviewed randomly selected treatment sessions from 176 participants and rated therapists on measures of CBT competence and CBT adherence. Patients were assessed at baseline and at 6-, 12-, and 18-month follow-ups on measures of anxiety, depression, and functioning, and an average Reliable Change Index was calculated as a composite measure of outcome. CBT competence and CBT adherence were entered as predictors of outcome, after controlling for baseline covariates. Higher CBT competence was associated with better clinical outcomes whereas CBT adherence was not. Also, CBT competence was inversely correlated with years of clinical experience and trended (not significantly, though) down as the study progressed. CBT adherence was inversely correlated with therapist tenure in the study. Therapist competence was related to improved clinical outcomes when CBT for anxiety disorders was delivered by novice clinicians with technology assistance. The results highlight the value of the initial training for novice therapists as well as booster training to limit declines in therapist adherence. © 2012 Wiley Periodicals, Inc.

  1. Heart Failure: From Research to Clinical Practice. (United States)

    Islam, Md Shahidul


    "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.

  2. Mapping the work-based learning of novice teachers: charting some rich terrain. (United States)

    Cook, Vivien


    Work-based non-formal learning plays a key role in faculty development yet these processes are yet to be described in detail in medical education. This study sets out to illuminate these processes so that potential benefits for new and inexperienced medical educators and their mentors can be realised. The non-formal learning processes of 12 novice teachers were investigated across hospital, general practice and medical school settings. The research sought to describe 'what' and 'how' non-formal learning takes place, and whether these processes differ across teaching sites. Both clinical and non-clinical teachers of medical undergraduates from one inner city medical school were recruited for the study. Through semi-structured interviews and a 'concept map', participants were asked to identify the people and tasks which they considered central to helping them become more expert as educators. Results identified non-formal learning across a number of key dimensions, including personal development, task and role performance, and optimising clinical teaching. This learning takes place as an outcome of experience, observation, reflection and student feedback. Non-formal learning is a significant aspect of the development of novice teachers and as such it needs to be placed more firmly upon the agenda of faculty development.

  3. Naturalistic Assessment of Novice Teenage Crash Experience (United States)

    Lee, Suzanne E.; Simons-Morton, Bruce G.; Klauer, Sheila E.; Ouimet, Marie Claude; Dingus, Thomas A.


    Background Crash risk is highest during the first months after licensure. Current knowledge about teenagers’ driving exposure and the factors increasing their crash risk is based on self-reported data and crash database analyses. While these research tools are useful, new developments in naturalistic technologies have allowed researchers to examine newly-licensed teenagers’ exposure and crash risk factors in greater detail. The Naturalistic Teenage Driving Study (NTDS) described in this paper is the first study to follow a group of newly-licensed teenagers continuously for 18 months after licensure. The goals of this paper are to compare the crash and near-crash experience of drivers in the NTDS to national trends, to describe the methods and lessons learned in the NTDS, and to provide initial data on driving exposure for these drivers. Methods A data acquisition system was installed in the vehicles of 42 newly-licensed teenage drivers 16 years of age during their first 18 months of independent driving. It consisted of cameras, sensors (accelerometers, GPS, yaw, front radar, lane position, and various sensors obtained via the vehicle network), and a computer with removable hard drive. Data on the driving of participating parents was also collected when they drove the instrumented vehicle. Findings The primary findings after 18 months included the following: (1) crash and near-crash rates among teenage participants were significantly higher during the first six months of the study than the final 12 months, mirroring the national trends; (2) crash and near-crash rates were significantly higher for teenage than adult (parent) participants, also reflecting national trends; (3) teenaged driving exposure averaged between 507-710 kilometers (315-441 miles) per month over the study period, but varied substantially between participants with standard errors representing 8-14 percent of the mean; and (4) crash and near-crash types were very similar for male and female

  4. Budgeting, funding, and managing clinical research projects. (United States)

    Hatfield, Elizabeth; Dicks, Elizabeth; Parfrey, Patrick


    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.

  5. Blockchain technology for improving clinical research quality. (United States)

    Benchoufi, Mehdi; Ravaud, Philippe


    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.

  6. Clinical Psychology and Research: epistemological notes

    Directory of Open Access Journals (Sweden)

    Emanuela Coppola


    Full Text Available The paper proposes a reflection on the relationship between clinical psychology and research, highlighting the constant epistemological crossing the two practices, empirical and professional. The paper warns against the pitfalls of reductionism that, in both cases, may impact the effectiveness of therapeutic results. In fact, both in clinical practice and is in psychological research, the mere application of techniques contradicts the specificity of the object of study (the mind which, rather, requires the constant attention to a complexity of variables and contextual elements essential for the understanding the psychic. Qualitative research has been a prolific space for dialogue and joint trials between research and clinical practice that has rehabilitated scientific dignity of affective and subjective for a long time confined to the ephemeral world of poetry and literature. It must therefore be a further extension of the convergence not only of qualitative and quantitative methods but also of training modules for researchers and practitioners are able to stimulate, in daily practice, confidence in the utility of scientific monitoring and detection of inter-subjective variables in research devices.

  7. Action research methodology in clinical pharmacy

    DEFF Research Database (Denmark)

    Nørgaard, Lotte Stig; Sørensen, Ellen Westh


    Introduction The focus in clinical pharmacy practice is and has for the last 30-35 years been on changing the role of pharmacy staff into service orientation and patient counselling. One way of doing this is by involving staff in change process and as a researcher to take part in the change process...... by establishing partnerships with staff. On the background of the authors' widespread action research (AR)-based experiences, recommendations and comments for how to conduct an AR-study is described, and one of their AR-based studies illustrate the methodology and the research methods used. Methodology AR...... is defined as an approach to research which is based on a problem-solving relationship between researchers and clients, which aims at both solving a problem and at collaboratively generating new knowledge. Research questions relevant in AR-studies are: what was the working process in this change oriented...

  8. 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) ...

  9. Random effects models in clinical research

    NARCIS (Netherlands)

    Cleophas, T. J.; Zwinderman, A. H.


    BACKGROUND: In clinical trials a fixed effects research model assumes that the patients selected for a specific treatment have the same true quantitative effect and that the differences observed are residual error. If, however, we have reasons to believe that certain patients respond differently

  10. The social value of clinical research. (United States)

    Habets, Michelle G J L; van Delden, Johannes J M; Bredenoord, Annelien L


    International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used in numerous ways in the research ethics literature. Because social value justifies involving human participants, especially in early human trials, this is problematic. Our analysis and interpretation of the concept social value has led to three proposals. First, as no direct benefits are expected for the research participants in first-in-human trials, we believe it is better to discuss a risk- value assessment instead of a risk - benefit assessment. This will also make explicit the necessity to have a clear and common use for the concept social value. Second, to avoid confusion we propose to limit the concept social value to the intervention tested. It is the expected improvement the intervention can bring to the wellbeing of (future) patients or society that is referred to when we speak about social value. For the sole purpose of gaining knowledge, we should not expose humans to potential harm; the ultimate justification of involving humans in research lies in the anticipated social value of the intervention. Third, at the moment only the validity of the clinical research proposal is a prerequisite for research to take place. We recommend making the anticipated social value a prerequisite as well. In this paper we analyze the use of the concept social value in research ethics. Despite its unavoidable ambiguity, we aim to find a best use of the concept, subject to its role in justifying involving humans in first

  11. Bothered by abstractness or engaged by cohesion? Experts' explanations enhance novices' deep-learning. (United States)

    Lachner, Andreas; Nückles, Matthias


    Experts' explanations have been shown to better enhance novices' transfer as compared with advanced students' explanations. Based on research on expertise and text comprehension, we investigated whether the abstractness or the cohesion of experts' and intermediates' explanations accounted for novices' learning. In Study 1, we showed that the superior cohesion of experts' explanations accounted for most of novices' transfer, whereas the degree of abstractness did not impact novices' transfer performance. In Study 2, we investigated novices' processing while learning with experts' and intermediates' explanations. We found that novices studying experts' explanations actively self-regulated their processing of the explanations, as they showed mainly deep-processing activities, whereas novices learning with intermediates' explanations were mainly engaged in shallow-processing activities by paraphrasing the explanations. Thus, we concluded that subject-matter expertise is a crucial prerequisite for instructors. Despite the abstract character of experts' explanations, their subject-matter expertise enables them to generate highly cohesive explanations that serve as a valuable scaffold for students' construction of flexible knowledge by engaging them in deep-level processing. PsycINFO Database Record (c) 2015 APA, all rights reserved.

  12. Concerns of the Novice Physical Education Teacher (United States)

    Gordon, Evelyn J.


    The purpose of this case study was to examine novice physical education teachers in the first and second year of teaching. Participants included two novice physical education teachers, John in Year 1 and Mark in Year 2. Methodology included observations, semistructured interviews, and documents. Data were analyzed using open coding and constant…

  13. Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies (United States)


    Physics of Cancer Metabolism This application seeks to put together a multidiscipline team of experts in various institutions in USA to assemble and...of this project is to build a research cohort of engaged volunteers that reflects the racial , ethnic, and socioeconomic diversity of New York City...assessed in a randomized, phase III clinical trial. Conflict of interest: Advisory Board: Joe O’Sullivan holds consulting/ advisory roles with Bayer

  14. 59th Clinical Research Division Research Day Briefing (United States)


    College of Lab Animal Medicine; Certified by American College of Veterinary Pathology 1 - PhD, Physiology/Biochem - Clinical Research Admin...Molecular Biology/Genomics - Next Generation Sequencing - Real Time PCR - Multi-Plex Assays Cell Biology - Flow Cytometry Microbiology Coagulation

  15. Reengineering Clinical Research Science: A Focus on Translational Research (United States)

    Ferrell, Courtney B.


    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…

  16. Clinical Research Careers: Reports from a NHLBI Pediatric Heart Network Clinical Research Skills Development Conference (United States)

    Lai, Wyman W.; Richmond, Marc; Li, Jennifer S.; Saul, J. Philip; Mital, Seema; Colan, Steven D.; Newburger, Jane W.; Sleeper, Lynn A.; McCrindle, Brain W.; Minich, L. LuAnn; Goldmuntz, Elizabeth; Marino, Bradley S.; Williams, Ismee A.; Pearson, Gail D.; Evans, Frank; Scott, Jane D.; Cohen, Meryl S.


    Background Wyman W. Lai, MD, MPH, and Victoria L. Vetter, MD, MPH. The Pediatric Heart Network (PHN), funded under the U.S. National Institutes of Health-National Heart, Lung, and Blood Institute (NIH–NHLBI), includes two Clinical Research Skills Development (CRSD) Cores, which were awarded to The Children's Hospital of Philadelphia and to the Morgan Stanley Children's Hospital of New York–Presbyterian. To provide information on how to develop a clinical research career to a larger number of potential young investigators in pediatric cardiology, the directors of these two CRSD Cores jointly organized a one-day seminar for fellows and junior faculty from all of the PHN Core sites. The participants included faculty members from the PHN and the NHLBI. The day-long seminar was held on April 29, 2009, at the NHLBI site, immediately preceding the PHN Steering Committee meeting in Bethesda, MD. Methods The goals of the seminar were 1) to provide fellows and early investigators with basic skills in clinical research 2) to provide a forum for discussion of important research career choices 3) to introduce attendees to each other and to established clinical researchers in pediatric cardiology, and 4) to publish a commentary on the future of clinical research in pediatric cardiology. Results The following chapters are compilations of the talks given at the 2009 PHN Clinical Research Skills Development Seminar, published to share the information provided with a broader audience of those interested in learning how to develop a clinical research career in pediatric cardiology. The discussions of types of clinical research, research skills, career development strategies, funding, and career management are applicable to research careers in other areas of clinical medicine as well. Conclusions The aim of this compilation is to stimulate those who might be interested in the research career options available to investigators. PMID:21167335

  17. Using Social Media and Professional Learning Communities as Tools for Novice Teacher Collegiality and Improved Self-Efficacy (United States)

    Bostick, Bradley


    Teacher attrition and the migration between schools and districts can have a negative impact on quality of education and teacher performance. Novice teachers leave the profession because they are overwhelmed by the workload and responsibilities of the job. In a previous action research cycle, I found that novice teachers' perceptions of…

  18. No effect of a graded training program on the number of running-related injuries in novice runners

    NARCIS (Netherlands)

    Buist, Ida; Bredeweg, Steef W.; van Mechelen, Willem; Lemmink, Koen A. P. M.; Pepping, Gert-Jan; Diercks, Ron L.

    Background: Although running has positive effects on health and fitness, the incidence of a running-related injury (RRI) is high. Research on prevention of RRI is scarce; to date, no studies have involved novice runners. Hypothesis: A graded training program for novice runners will lead to a

  19. Maintenance of Clinical Expertise and Clinical Research by the Clinical Professors at Gifu Pharmaceutical University. (United States)

    Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi


    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.

  20. Indian novice nurses' perceptions of their role in caring for women who have experienced intimate partner violence. (United States)

    Gandhi, Sailaxmi; Poreddi, Vijayalakshmi; Nikhil, Reddy Ss; Palaniappan, Marimuthu; Math, Suresh Bada


    intimate partner violence (IPV) is a significant health problem and a gross violation of the human rights of women. Nurses play an important role in providing support for these women. There is limited research on nurses' understanding and perceptions of their role in caring for women with IPV issues in India. to assess novice nurses' perceptions of self-efficacy, educational preparedness and their role in this area. this was a cross-sectional descriptive survey carried out among a convenience sample of novice nurses (n=83) at a tertiary care centre using self-reported questionnaires. a majority of the subjects were confident and had adequate knowledge in dealing with women who have experienced IPV. A significantly positive relationship was found between educational preparedness and self-efficacy and attitudes towards nurses' roles in caring for these women. novice nurses were confident and held positive attitudes towards women who experienced IPV. Yet their self-efficacy in caring for these patients could be improved through continuing education and there is an urgent need to integrate comprehensive training on IPV to improve clinical competencies, including how to refer women for further support.

  1. How to…write a good research question

    NARCIS (Netherlands)

    Mattick, Karen; Johnston, Jenny; de la Croix, Anne

    This paper, on writing research questions, is the first in a series that aims to support novice researchers within clinical education, particularly those undertaking their first qualitative study. Put simply, a research question is a question that a research project sets out to answer. Most research

  2. A research mentor training curriculum for clinical and translational researchers. (United States)

    Pfund, Christine; House, Stephanie; Spencer, Kimberly; Asquith, Pamela; Carney, Paula; Masters, Kristyn S; McGee, Richard; Shanedling, Janet; Vecchiarelli, Stephanie; Fleming, Michael


    To design and evaluate a research mentor training curriculum for clinical and translational researchers. The resulting 8-hour curriculum was implemented as part of a national mentor training trial. The mentor training curriculum was implemented with 144 mentors at 16 academic institutions. Facilitators of the curriculum participated in a train-the-trainer workshop to ensure uniform delivery. The data used for this report were collected from participants during the training sessions through reflective writing, and following the last training session via confidential survey with a 94% response rate. A total of 88% of respondents reported high levels of satisfaction with the training experience, and 90% noted they would recommend the training to a colleague. Participants also reported significant learning gains across six mentoring competencies as well as specific impacts of the training on their mentoring practice. The data suggest the described research mentor training curriculum is an effective means of engaging research mentors to reflect upon and improve their research mentoring practices. The training resulted in high satisfaction, self-reported skill gains as well as behavioral changes of clinical and translational research mentors. Given success across 16 diverse sites, this training may serve as a national model. © 2012 Wiley Periodicals, Inc.

  3. Significant Value Found in Mentoring Programs for Novice Tenure-Track Academic Librarians


    Saori Wendy Herman, MLIS, AHIP


    A Review of: Goodsett, M., & Walsh, A. (2015). Building a strong foundation: Mentoring programs for novice tenure-track librarians in academic libraries. College & Research Libraries, 76(7), 914-933. Objective – To examine the effectiveness of mentoring programs for novice tenure-track academic librarians, and to identify critical elements that define a successful mentoring program in various academic library settings. Design – Survey questionn...

  4. Dialando: tangible programming for the novice with scratch, processing and arduino

    CSIR Research Space (South Africa)

    Smith, Andrew C


    Full Text Available Programming for the Novice with Scratch, Processing and Arduino Andrew Cyrus Smith CSIR Meraka Institute, PO Box 395, Pretoria, 0001, South Africa acsmith @ Abstract This paper reports on a tangible programming system designed... the Arduino controlling circuitry which is connected to the laptop computer using a USB cable. 2. Our Approach Our research aims to provide the novice user a gentle introduction to the abstract programming abilities of the PC. In order to achieve...

  5. Bringing ayahuasca to the clinical research laboratory. (United States)

    Riba, Jordi; Barbanoj, Manel J


    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.

  6. Current clinical research in orthodontics: a perspective. (United States)

    Baumrind, Sheldon


    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.

  7. Periprosthetic Joint Infections: Clinical and Bench Research

    Directory of Open Access Journals (Sweden)

    Laurence Legout


    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.

  8. Negotiation skills for clinical research professionals

    Directory of Open Access Journals (Sweden)

    Sanjay Hake


    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.

  9. Negotiation skills for clinical research professionals (United States)

    Hake, Sanjay; Shah, Tapankumar


    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

  10. Clinical Research Informatics: Supporting the Research Study Lifecycle. (United States)

    Johnson, S B


    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.

  11. Nursing research. Components of a clinical research study. (United States)

    Bargagliotti, L A


    Nursing research is the systematic collection and analysis of data about clinically important phenomena. While there are norms for conducting research and rules for using certain research procedures, the reader must always filter the research report against his or her nursing knowledge. The most common questions a reader should ask are "Does it make sense? Can I think of any other reasonable explanation for the findings? Do the findings fit what I have observed?" If the answers are reasonable, research findings from carefully conducted studies can provide a basis for making nursing decisions. One of the earliest accounts of nursing research, which indicates the power of making systematic observations, was Florence Nightingale's study. It compared deaths among soldiers in the Crimean War with deaths of soldiers in the barracks of London. Her research demonstrated that soldiers in the barracks had a much higher death rate than did the soldiers at war. On the basis of the study, sanitary conditions in the barracks were changed substantially.

  12. Using connected objects in clinical research. (United States)

    Dhainaut, Jean-François; Huot, Laure; Pomar, Valérie Bouchara; Dubray, Claude


    Connected objects (CO), whether medical devices or not, are used in clinical research for data collection, a specific activity (communication, diagnosis, effector, etc.), or several functions combined. Their validation should be based on three approaches: technical and clinical reliability, data protection and cybersecurity. Consequently, the round table recommends that the typology of COs, their uses and limitations, be known and shared by all, particularly for implementing precise specifications. COs are used in clinical research during observational studies (assessment of the device itself or data collection), randomized studies, where only one group has a CO (assessment of its impact on patient follow-up or management), or randomized studies where both groups have a CO, which is then used as a tool to help with assessment. The benefits of using COs in clinical research includes: improved collection and quality of data, compliance of patients and pharmacovigilance, easier implementation of e-cohorts and a better representative balance of patients. The societal limits and risks identified relate to the sometimes intrusive nature of certain collected parameters and the possible misuse of data. The round table recommends the following on this last point: anticipation, by securing transmission methods, the qualification of data hosts, and assessment of the object's vulnerability. For this, a risk analysis appears necessary for each project. It is also necessary to accurately document the data flow, in order to inform both patients and healthcare professionals and to ensure adequate security. Anticipating regulatory changes and involving users starting from the study design stage are also recommended. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  13. [Alfredo Lanari, a clinical research style]. (United States)

    Romero, Lucía


    The institutionalization of clinical research in Argentina reached its point of greatest maturity with the creation, in 1957, of the Institute of Medical Investigations (Instituto de Investigaciones Médicas) of the Faculty of Medicine of the Universidad de Buenos Aires, and the drive of the man who was its director for almost 20 years, Alfredo Lanari. In this paper I analyze the ways in which he generated a style of clinical research and a referential position in local medical field that allowed him to carry out said institutional realization. This achievement was the result of a personal enterprise and at the same time part of a larger context of transformations within the medical discipline world-wide and at the Universidad de Buenos Aires. This study was carried out combining oral and documentary sources, such as interviews with physicians at the Institute of Medical Investigations, members of the journal Medicina and of the Argentine Society of Clinical Investigation (Sociedad Argentina de Investigación Clínica), as well as academic files and scientific articles.

  14. Biomechanical differences between expert and novice workers in a manual material handling task. (United States)

    Plamondon, Andre; Denis, Denys; Delisle, Alain; Lariviere, Christian; Salazar, Erik


    The objective was to verify whether the methods were safer and more efficient when used by expert handlers than by novice handlers. Altogether, 15 expert and 15 novice handlers were recruited. Their task was to transfer four boxes from a conveyor to a hand trolley. Different characteristics of the load and lifting heights were modified to achieve a larger variety of methods by the participants. The results show that the net moments at the L5/S1 joint were not significantly different (p > 0.05) for the two groups. However, compared with the novices, the experts bent their lumbar region less (experts 54° (SD 11°); novices 66° (SD 15°)) but bent their knees more (experts approx. 72° (SD approx. 30°); novices approx. 53° (SD approx. 33°), which brought them closer to the box. The handler's posture therefore seems to be a major aspect that should be paid specific attention, mainly when there is maximum back loading. STATEMENT OF RELEVANCE: The findings of this research will be useful for improving manual material handling training programmes. Most biomechanical research is based on novice workers and adding information about the approach used by expert handlers in performing their tasks will help provide new avenues for reducing the risk of injury caused by this demanding physical task.

  15. Clinical Research Strategies for Fructose Metabolism12 (United States)

    Laughlin, Maren R.; Bantle, John P.; Havel, Peter J.; Parks, Elizabeth; Klurfeld, David M.; Teff, Karen; Maruvada, Padma


    Fructose and simple sugars are a substantial part of the western diet, and their influence on human health remains controversial. Clinical studies in fructose nutrition have proven very difficult to conduct and interpret. NIH and USDA sponsored a workshop on 13–14 November 2012, “Research Strategies for Fructose Metabolism,” to identify important scientific questions and parameters to be considered while designing clinical studies. Research is needed to ascertain whether there is an obesogenic role for fructose-containing sugars via effects on eating behavior and energy balance and whether there is a dose threshold beyond which these sugars promote progression toward diabetes and liver and cardiovascular disease, especially in susceptible populations. Studies tend to fall into 2 categories, and design criteria for each are described. Mechanistic studies are meant to validate observations made in animals or to elucidate the pathways of fructose metabolism in humans. These highly controlled studies often compare the pure monosaccharides glucose and fructose. Other studies are focused on clinically significant disease outcomes or health behaviors attributable to amounts of fructose-containing sugars typically found in the American diet. These are designed to test hypotheses generated from short-term mechanistic or epidemiologic studies and provide data for health policy. Discussion brought out the opinion that, although many mechanistic questions concerning the metabolism of monosaccharide sugars in humans remain to be addressed experimentally in small highly controlled studies, health outcomes research meant to inform health policy should use large, long-term studies using combinations of sugars found in the typical American diet rather than pure fructose or glucose. PMID:24829471

  16. Frequent methodological errors in clinical research. (United States)

    Silva Aycaguer, L C


    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.

  17. Clinical leadership and pre-registration nursing programmes: A model for clinical leadership and a prospective curriculum implementation and evaluation research strategy. (United States)

    Brown, Angela; Dewing, Jan; Crookes, Patrick


    To present for wider debate a conceptual model for clinical leadership development in pre-registration nursing programmes and a proposed implementation plan. Globally, leadership in nursing has become a significant issue. Whilst there is continued support for leadership preparation in pre-registration nursing programmes, there have been very few published accounts of curriculum content and/or pedagogical approaches that foster clinical leadership development in pre-registration nursing. A doctoral research study has resulted in the creation of an overarching model for clinical leadership. A multi-method research study using theoretical and empirical literature 1974-2015, a focus group, expert opinion and a national on-line survey. A conceptual model of clinical leadership development in pre-registration nursing programme is presented, including the infinity loop of clinical leadership, an integral curriculum thread and a conceptual model: a curriculum-pedagogy nexus for clinical leadership. In order to test out usability and evaluate effectiveness, a multi method programme of research in one school of nursing in Australia is outlined. Implementation of the proposed conceptual model for clinical leadership development in pre-registration nursing programmes and a programme of (post-doctoral) research will contribute to what is known about curriculum content and pedagogy for nurse academics. Importantly, for nursing students and the profession as a whole, there is a clearer expectation of what clinical leadership might look like in the novice registered nurse. For nurse academics a model is offered for consideration in curriculum design and implementation with an evaluation strategy that could be replicated. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Mindfulness for Novice Pediatric Nurses: Smartphone Application Versus Traditional Intervention. (United States)

    Morrison Wylde, Chelsey; Mahrer, Nicole E; Meyer, Rika M L; Gold, Jeffrey I

    The current study compares the effects of a traditionally delivered mindfulness (TDM) intervention to a smartphone delivered mindfulness (SDM) intervention, Headspace, an audio-guided mindfulness meditation program, in a group of novice nurses. Novice nurses participating in a pediatric nurse residency program were asked to participate in either a TDM or SDM intervention. Participants (N=95) completed self-administered pencil and paper questionnaires measuring mindfulness skills, and risk and protective factors at the start of their residency and three months after entering the program. Nurses in the SDM group reported significantly more "acting with awareness" and marginally more "non-reactivity to inner experience" skills compared to the TDM group. The smartphone intervention group also showed marginally more compassion satisfaction and marginally less burnout. Additionally, nurses in the SDM group had lower risk for compassion fatigue compared to the TDM group, but only when the nurses had sub-clinical posttraumatic symptoms at the start of the residency training program. Smartphone delivered mindfulness interventions may provide more benefits for novice nurses than traditionally delivered mindfulness interventions. However, the smart-phone intervention may be better indicated for nurses without existing symptoms of posttraumatic stress. Mindfulness interventions delivered through smartphone applications show promise in equipping nurses with important coping skills to manage stress. Because of the accessibility of smartphone applications, more nurses can benefit from the intervention as compared to a therapist delivered intervention. However, nurses with existing stress symptoms may require alternate interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Information technology for clinical, translational and comparative effectiveness research. Findings from the section clinical research informatics. (United States)

    Daniel, C; Choquet, R


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

  20. Menstrual questionnaires for clinical and research use. (United States)

    Matteson, Kristen A


    Patient-reported outcome measures (PROMs) have the potential to be extremely valuable in the clinical care delivery for women who report heavy menstrual bleeding (HMB). Increasingly, studies on HMB have incorporated PROMs to evaluate the impact of bleeding on quality of life. These measures have included semiquantitative charts and pictograms, questionnaires to assess symptoms and impact on quality of life, and health-related quality of life questionnaires. Recent systematic reviews have highlighted inconsistency of outcome measurement across studies on HMB as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options. Consequently, research initiatives and international collaborations are working to harmonize outcome measurement. Harmonizing the use of questionnaires in research and clinical care has the potential to improve patient-centered care delivery for women with HMB and improve the generation of patient-focused evidence-based guidelines for the evaluation and treatment of HMB. Copyright © 2016. Published by Elsevier Ltd.

  1. Glutamate in schizophrenia: clinical and research implications. (United States)

    Goff, D C; Wine, L


    The excitatory amino acids, glutamate and aspartate, are of interest to schizophrenia research because of their roles in neurodevelopment, neurotoxicity and neurotransmission. Recent evidence suggests that densities of glutamatergic receptors and the ratios of subunits composing these receptors may be altered in schizophrenia, although it is unclear whether these changes are primary or compensatory. Agents acting at the phencyclidine binding site of the NMDA receptor produce symptoms of schizophrenia in normal subjects, and precipitate relapse in patients with schizophrenia. The improvement of negative symptoms with agents acting at the glycine modulatory site of the NMDA receptor, as well as preliminary evidence that clozapine may differ from conventional neuroleptic agents in its effects on glutamatergic systems, suggest that clinical implications may follow from this model. While geriatric patients may be at increased risk for glutamate-mediated neurotoxicity, very little is known about the specific relevance of this model to geriatric patients with schizophrenia.

  2. Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators. (United States)

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


    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.

  3. 78 FR 28292 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board; Notice of Meetings; Amendment The... Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development...

  4. Metapsychological and clinical issues in psychosomatics research. (United States)

    Press, Jacques


    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.

  5. Clinical Trials: A Crucial Key to Human Health Research (United States)

    ... Past Issues Clinical Trials: A Crucial Key to Human Health Research Past Issues / Summer 2006 Table of Contents ... Javascript on. Photo: PhotoDisc At the forefront of human health research today are clinical trials—studies that use ...

  6. 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.


    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

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

    NARCIS (Netherlands)

    Staphorst, Mira S.; Hunfeld, Joke A. M.; van de Vathorst, Suzanne; Passchier, Jan; van Goudoever, Johannes B.


    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 more insight

  8. Clinical Research Nursing: Development of a Residency Program
. (United States)

    Showalter, Brandi L; Cline, Debbie; Yungclas, Jan; Frentz, Kelly; Stafford, Susan R; Maresh, Kelly J


    Clinical research nurses are essential in the coordination of clinical trials and the management of research participants. Without a stable, knowledgeable research nurse workforce, the conduct of research is affected. A research nurse residency is a novel approach to preparing new graduate nurses for the oncology research nurse role. This article will describe the development and content of the research nurse residency and how this approach is being used to address a need for clinical research nurses to support burgeoning clinical trials at a National Cancer Institute-designated comprehensive cancer center.

  9. Report of the Task Force on Clinical Research in Dentistry. (United States)

    Journal of Dental Education, 1994


    A report on clinical dental research reviews current conditions and makes recommendations for increased funding, improved peer review for research proposals, establishment of a well-defined training track for clinical researchers, and better institutional integration of and support for research and teaching. Projected need for researchers is also…

  10. Distance-mediated mentoring: A telecommunication-supported model for novice rural mathematics and science teachers (United States)

    Luebeck, Jennifer Lyn

    Rural educators face unique professional challenges and limitations. This study investigated the effectiveness of an innovative distance-mediated mentoring program for rural novice mathematics and science teachers. Four purposes were pursued: (1) characterize and document the nature and development of the mentor-novice relationship; (2) describe how discourse influenced the novice teachers' perceptions about mathematics and science teaching; (3) determine whether telecommunication effectively supported a distance-mediated mentoring relationship for novice rural teachers; and (4) investigate program effects on novice teachers' attitudes, concerns, and professional growth. A qualitative research design was implemented during academic years 1996-98. Primary data collection focused on nine rural novice teachers and their mentors and included three sets of interviews spanning three semesters, field observation of classrooms, schools, and communities, and analysis of electronic mail messages over a four-month period. Supporting data were collected during observation of workshops and training sessions, and through surveys administered to all program participants in early 1997 and 1998. Categories of mentor-novice communication were identified: curriculum and content, validation of teaching practice, classroom and school issues, moral support, and social talk. Impact on mathematics and science teaching was accomplished by: sharing materials and activities; planning units and projects; locating resources; classroom and student concerns; long-range curriculum design, and improvement of teaching practices. Professional growth (for both novices and mentors) occurred through individual contact with partners and interaction within the larger mentoring community in both face-to-face and on-line venues. Telecommunication was highly valued by successful users. Technical difficulty curtailed access for a significant number of teachers, but they maintained successful relationships

  11. [Support Team for Investigator-Initiated Clinical Research]. (United States)

    Fujii, Hisako


    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]. (United States)

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


    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. Novice teen driving : education and training administrative standards. (United States)


    The Novice Teen Driver Education and Training Administrative Standards set forth in this document serve to guide all novice teen driver education and training programs in States striving to provide quality, consistent driver education and training. W...

  14. Infant intersubjectivity: research, theory, and clinical applications. (United States)

    Trevarthen, C; Aitken, K J


    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

  15. Challenges and Induction Needs of Novice English as a Foreign Language Teachers in Saudi Arabia

    Directory of Open Access Journals (Sweden)

    Rufaida Alhamad


    Full Text Available The first year of teaching poses massive challenges that lead to attrition among novice teachers. School communities often fail to provide adequate support to novice teachers to help them adapt to their new professional environments. In Saudi Arabia, attrition among novice teachers is a significant problem that hinders the development of the educational system. This study was conducted to examine the challenges that Saudi Arabian EFL novice teachers face as they transit into their first teaching jobs, and to determine whether these teachers have adequate support or would benefit from a formal induction process.  Two kinds of data collection methods were used in this study, namely quantitative and qualitative. In this mixed methods study, 150 novice teachers were surveyed and 5 teachers were selected for semi-structured interviews. The quantitative analysis of the data was accomplished using descriptive and inferential statistics to answer the research questions. The qualitative analysis of the data was accomplished by interpreting the responses provided to the interview questions. The findings indicated that the challenges surrounding novice teachers hinder them in their development as new teachers. The most conspicuous challenges reported by the study participants were dealing with low English proficiency students and managing the negative attitudes of students toward learning English. This report also determined additional perceptible challenges: adoption of various teaching methods and the establishment of a student-centered approach, student behavior management, course planning, dealing with individual differences, and communication with parents.  This study showed that these teachers had left their pre-service training with a very limited knowledge and skills for dealing with the reality of teaching. Mentoring and observing veteran teachers were identified by novice teachers as the two most beneficial strategies for implementing a teacher

  16. 77 FR 26069 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board, Notice of Meeting Amendment The... Development and Clinical Science Research and Development Services Scientific Merit Review Board have changed...

  17. Novice Music Teachers Learning to Improvise in an Improvisation Professional Development Workshop (United States)

    Filsinger, Mark H.


    With the intent of improving music improvisation pedagogy, the purpose of this research was to examine experiences of six novice music teachers and a professional development facilitator in an eight-week Improvisation Professional Development Workshop (IPDW). The research questions were: 1. How do teachers learn to improvise within the context of…

  18. A Content Analysis Concerning the Studies on Challenges Faced by Novice Teachers (United States)

    Kozikoglu, Ishak


    The purpose of this research is to analyze the studies concerning challenges faced by novice teachers in terms of various aspects and compare challenges according to location of the studies conducted in Turkey and abroad. A total of 30 research studies were included in detailed analysis. This is a descriptive study based on qualitative research…

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

    DEFF Research Database (Denmark)

    Smed, Marie; Getz, Kenneth A.


    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...

  20. Functional MRI in children: clinical and research applications

    International Nuclear Information System (INIS)

    Leach, James L.; Holland, Scott K.


    Functional MRI has become a critical research tool for evaluating brain function and developmental trajectories in children. Its clinical use in children is becoming more common. This presentation will review the basic underlying physiologic and technical aspects of fMRI, review research applications that have direct clinical relevance, and outline the current clinical uses of this technology. (orig.)

  1. Novice Teachers and Linguistics: Foregrounding the Functional (United States)

    Chappell, Phil; Moore, Stephen


    This forum article describes a postgraduate certificate teaching English to speakers of other languages (TESOL) program with a strong linguistics orientation and argues that such a program provides novice language teachers with knowledge and skills superior to those of programs which focus more on methodology and practicum experience and less on…

  2. Using Facebook to Support Novice Teachers (United States)

    Staudt, Denise; St. Clair, Norman; Martinez, Elda E.


    Providing quality support for novice teachers as they enter the profession has been an ongoing concern of educator preparation programs. This article describes the efforts of one teacher preparation program in addressing this matter by utilizing Facebook[R] to provide sustained support and professional development for its beginning teachers. We…

  3. Predictors of Errors of Novice Java Programmers (United States)

    Bringula, Rex P.; Manabat, Geecee Maybelline A.; Tolentino, Miguel Angelo A.; Torres, Edmon L.


    This descriptive study determined which of the sources of errors would predict the errors committed by novice Java programmers. Descriptive statistics revealed that the respondents perceived that they committed the identified eighteen errors infrequently. Thought error was perceived to be the main source of error during the laboratory programming…

  4. Novice Career Changers Weather the Classroom Weather (United States)

    Gifford, James; Snyder, Mary Grace; Cuddapah, Jennifer Locraft


    A close look at one professional's career change into teaching illustrates unique challenges and qualities, showing in stark relief what makes the induction smoother and the experience more successful. This article presents the story of a novice career changer teacher that illustrates their unique problems and dispositions, as well as…

  5. Novice and experienced teachers’ views on professionalism

    NARCIS (Netherlands)

    Okas, Anne; van der Schaaf, Marieke; Krull, Edgar


    This article discusses teachers’ practical knowledge and beliefs of their profession based on reflective writings of twenty Estonian teachers.Ten novice and ten experienced teachers participated in the study. They put together their professional portfolios, which among other documents included

  6. The Affective Experience of Novice Computer Programmers (United States)

    Bosch, Nigel; D'Mello, Sidney


    Novice students (N = 99) participated in a lab study in which they learned the fundamentals of computer programming in Python using a self-paced computerized learning environment involving a 25-min scaffolded learning phase and a 10-min unscaffolded fadeout phase. Students provided affect judgments at approximately 100 points (every 15 s) over the…

  7. Framing Behaviours in Novice Interaction Designers (United States)

    Lotz, Nicole; Sharp, Helen; Woodroffe, Mark; Blyth, Richard; Rajah, Dino; Ranganai, Turugare


    Framing design problems and solutions has been recognised in design studies as a central designerly activity. Some recent findings with expert designers relate framing practices to problem-solution co-evolution and analogy use, two further widely recognised design strategies. We wanted to understand if interaction design novices also use…

  8. Novice Teachers' Attention to Student Thinking (United States)

    Levin, Daniel M.; Hammer, David; Coffey, Janet E.


    Stage-based views of teacher development hold that novice teachers are unable to attend to students' thinking until they have begun to identify themselves as teachers and mastered classroom routines, and so the first emphases in learning to teach should be on forming routines and identity. The authors challenge those views, as others have done,…

  9. String Formatting Considered Harmful for Novice Programmers (United States)

    Hughes, Michael C.; Jadud, Matthew C.; Rodrigo, Ma. Mercedes T.


    In Java, "System.out.printf" and "String.format" consume a specialised kind of string commonly known as a format string. In our study of first-year students at the Ateneo de Manila University, we discovered that format strings present a substantial challenge for novice programmers. Focusing on their first laboratory we found…

  10. International market research at the Mayo Clinic. (United States)

    Hathaway, M; Seltman, K


    Mayo Clinic has a long international history and has been providing care to international patients since its inception. Despite its history and reputation, however, the marketing staff continues to monitor the international market to gauge the level of awareness, reputation, and attractiveness of Mayo Clinic around the world. Here's a look at how one institution has used word-of-mouth marketing to maintain its global reputation.

  11. 76 FR 19188 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and... (United States)


    ... 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.... Neurobiology-D June 10, 2011 Crowne Plaza DC/Silver Spring. Clinical Research Program June 13, 2011 VA Central...

  12. 78 FR 66992 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and... (United States)


    ... 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..., behavioral, and clinical science research. The panel meetings will be open to the public for approximately...

  13. 75 FR 57833 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and... (United States)


    ... 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... Crowne Plaza Clinical Research Program December 3, 2010 *VA Central Office Mental Hlth & Behav Sci-A...

  14. 78 FR 22622 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and... (United States)


    ... 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... biomedical, behavioral and clinical science research. The panel meetings will be open to the public for...

  15. 75 FR 23847 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and... & Behav Sci-A June 7, 2010 L'Enfant Plaza Hotel. Clinical Research Program June 9, 2010 *VA Central Office...

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


    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.

  17. Cultural humility: essential foundation for clinical researchers. (United States)

    Yeager, Katherine A; Bauer-Wu, Susan


    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.

  18. Conducting research in clinical psychology practice: Barriers, facilitators, and recommendations. (United States)

    Smith, Kirsten V; Thew, Graham R


    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.

  19. Barriers to Clinical Research in Latin America


    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


    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...

  20. Novice facilitators and the use of scripts for managing facilitated modelling workshops

    DEFF Research Database (Denmark)

    Tavella, Elena; Papadopoulos, Thanos


    There is limited research on the use of scripts by novice facilitators (novices) in Facilitated Modelling (FM) workshops. To address this gap, this paper illustrates how novices—supported by scripts—switch between and combine facilitation skills and competencies to successfully manage FM workshops...... and achieve outcomes. This illustration is based on a micro-level analysis of a transcript from a Viable System Model workshop held in a food cooperative in Copenhagen, Denmark. Through our findings we identify two distinct script-supported FM behaviours and related script-supported facilitation practices...... that enable novices to (a) acquire skills and competencies; and (b) switch between and combine skills and competencies to successfully manage workshops and achieve outcomes. Our study links micro-level considerations to a meta-level framework that relates the script-supported FM behaviours and practices...

  1. Ensuring rigour and trustworthiness of qualitative research in clinical pharmacy. (United States)

    Hadi, Muhammad Abdul; José Closs, S


    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.

  2. Hypofractionated stereotactic irradiation. Basic and clinical researches

    International Nuclear Information System (INIS)

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


    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)

  3. Facilitating programming comprehension for novice learners with multimedia approach: A preliminary investigation (United States)

    Annamalai, Subashini; Salam, Sobihatun Nur Abdul


    This research paper presents the preliminary investigation on the use of an interactive multimedia courseware named MAFPro, to facilitate C Programming lessons for novice learners. The courseware utilizes the elements of multimedia that focus on enhancing learners' programming comprehension. Among the aspects that were examined were the students' programming comprehension and their perceived motivation of MAFPro. This study was carried out in a survey design method with the participation of 30 undergraduates who are novice learners. The data analysis indicates that the multimedia courseware, MAFPro that has been used in the C programming classroom has a significant difference on the undergraduates' programming comprehension. The students also perceived MAFPro as motivating and engaging.

  4. Lived Experiences of Novice Male Nurses in Taiwan. (United States)

    Cheng, Mei-Li; Tseng, Ying-Hua; Hodges, Eric; Chou, Fan-Hao


    Nursing remains a female-dominated profession around the world. The masculinity and male identity of men who choose nursing careers is questioned by the general public in many countries. Few studies report the situation of novice male nurses at their first year. The purpose of this study was to explore the lived experience of novice male nurses when they first enter the workplace. A qualitative descriptive study was conducted using purposive and snowball sampling for recruitment. Fourteen participants, 21 to 25 years old, were recruited, all of whom had at least 5 months of work experience. On average, in-depth, face-to-face interviews lasted 1 hour, with more than one follow-up telephone interview per participant. The following six themes emerged from the transcribed verbatim data based on content analysis: choosing appropriate work departments based on personality and needs, facing the pressure and frustration of independent work, getting help, obtaining acceptance among female cliques, reflecting on the relationship between gender and profession, and concerns about dependents and financial needs. This study addresses masculinity issues and gender stereotyping. In addition, male nurses were very concerned about their career options and development and the likelihood of promotion. This research not only has implications for better understanding of novice male nurses' needs and the challenges in their social life but also makes suggestions for nursing practice to attract and keep more male nurses in the nursing profession. The results illustrate how culturally congruent nursing care can be achieved when we more concern male nurses' role pressure and address traditional gender sensitivity to promote male nurses' career development. © The Author(s) 2016.

  5. International Partnerships for Clinical Cancer Research (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.

  6. The clinical applicability of music therapy research

    DEFF Research Database (Denmark)

    Wigram, Anthony Lewis

    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...

  7. [Clinical research XXIV. From clinical judgment to ethics in research on humans]. (United States)

    Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Rivas-Ruiz, Rodolfo; Talavera, Juan O


    Bioethics in research is an essential part of the structured review process of an article and it is based on three fundamental principles: respect for persons, beneficence and justice. In addition to not providing valid knowledge, a research with inadequate design, execution and statistical analysis is not ethical either, since these methodological deficiencies will produce information that will not be useful and, therefore, the risks that the participants were exposed to will have been in vain. Beyond scientific validity, there are other aspects that outline if an investigation is ethical, such as the clinical and social value of a study, a fair selection of participants, favorable risk-benefit balance, an independent review, the informed consent and respect for participants and potential participants. Throughout the article here presented, the documents that profile the behavior of investigators to protect the participants, such as the Declaration of Helsinki, the national regulations that rule us and the differences between research without risk, with minimal risk and with greater than minimal risk are discussed. That like in daily life, behavior in research involving human participants must be self-regulated, ie, people with knowledge of the existence of the law discover that the man is outside the realm of nature where work is done under the necessity of natural causality, and falls within the scope of the will; only if the man is free to decide their actions may be a law regulating their action.

  8. Altruism in clinical research: coordinators' orientation to their professional roles. (United States)

    Fisher, Jill A; Kalbaugh, Corey A


    Research coordinators have significant responsibilities in clinical trials that often require them to find unique ways to manage their jobs, thus reshaping their professional identities. The purpose of this study was to identify how research coordinators manage role and ethical conflicts within clinical research trials. A qualitative study combining observation and 63 semistructured interviews at 25 research organizations was used. Altruism is a recurring theme in how research coordinators define and view their work. Altruism is adopted by research coordinators to: (1) Teach patient-subjects the appropriate reasons to participate in clinical research, (2) minimize the conflict between research and care, and (3) contest the undervaluation of coordinating. Altruism is a strategy used to handle the various conflicts they experience in a difficult job, and it has become part of the professional identity of clinical research coordinators. Copyright © 2012 Elsevier Inc. All rights reserved.

  9. [An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials]. (United States)

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


    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.

  10. Research Training in the Biomedical, Behavioral, and Clinical Research Sciences (United States)

    National Academies Press, 2011


    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…

  11. Research-active clinical nurses: against all odds. (United States)

    Siedlecki, Sandra L; Albert, Nancy M


    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.

  12. 59th Medical Wing Clinical Research Division Clinical Investigations Program Pathology Poster (United States)


    59 MDW/SGVU SUBJECT: Professional Presentation Approval 1. Your paper, entitled 59th Medical Wing Clinical Research Division Clinical Investigations...Program Pathology Poster presented at/published to For hanging in a hallway of the 591h Medical Wing Clinical Research Division, Bldg 4430 in...Graduate Health Sciences Education student and your department has told you they cannot fund your publication, the 59th Clinical Research Division may

  13. Frequently Asked Questions about Clinical Research (United States)

    ... Care Genomic Medicine Working Group New Horizons and Research Patient Management Policy and Ethics Issues Quick Links for Patient Care Education All About the Human Genome Project Fact Sheets Genetic Education Resources for ...

  14. [Clinical research XXIII. From clinical judgment to meta-analyses]. (United States)

    Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Noyola-Castillo, Maura E; Talavera, Juan O


    Systematic reviews (SR) are studies made in order to ask clinical questions based on original articles. Meta-analysis (MTA) is the mathematical analysis of SR. These analyses are divided in two groups, those which evaluate the measured results of quantitative variables (for example, the body mass index -BMI-) and those which evaluate qualitative variables (for example, if a patient is alive or dead, or if he is healing or not). Quantitative variables generally use the mean difference analysis and qualitative variables can be performed using several calculations: odds ratio (OR), relative risk (RR), absolute risk reduction (ARR) and hazard ratio (HR). These analyses are represented through forest plots which allow the evaluation of each individual study, as well as the heterogeneity between studies and the overall effect of the intervention. These analyses are mainly based on Student's t test and chi-squared. To take appropriate decisions based on the MTA, it is important to understand the characteristics of statistical methods in order to avoid misinterpretations.

  15. How to emerge from the conservatism in clinical research methodology? (United States)

    Kotecki, Nuria; Penel, Nicolas; Awada, Ahmad


    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.

  16. 77 FR 64598 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical...) that the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science... areas of biomedical, behavioral and clinical science research. The panel meetings will be open to the...

  17. Development of PCK for Novice and Experienced University Physics Instructors: A Case Study (United States)

    Jang, Syh-Jong; Tsai, Meng-Fang; Chen, Ho-Yuan


    The current study assessed and compared university students' perceptions' of a novice and an experienced physics instructor's Pedagogical Content Knowledge (PCK). Two college physics instructors and 116 students voluntarily participated in this study. The research model comprised three workshops, mid-term and final evaluations and instructor…

  18. Exploring Novice and Experienced Teachers' Perceptions of Motivational Constructs with Adolescent Students (United States)

    Wiesman, Jeff


    The purpose of this study was to compare novice and experienced teachers' perceptions of student motivation at the high school level and to determine if the teachers were likely to incorporate research-based techniques. Survey data were collected on the following motivational constructs: intrinsic and extrinsic motivation; performance, mastery,…

  19. Evaluating the Effectiveness Roles of Variables in the Novice Programmers Learning (United States)

    Shi, Nianfeng; Cui, Wen; Zhang, Ping; Sun, Ximing


    This research applies the roles of variables to the novice programmers in the C language programming. The results are evaluated using the Structure of Observed Learning Outcomes (SOLO) taxonomy. The participants were divided into an experimental group and a control group. The students from the control group learned programming in the traditional…

  20. Initial Evaluation of a Mobile Scaffolding Application That Seeks to Support Novice Learners of Programming (United States)

    Mbogo, Chao; Blake, Edwin; Suleman, Hussein


    The aim of this paper is to explore the use of an application that scaffolds the constructions of programs on a mobile device. The application was developed to support novice learners of programming outside the classroom. This paper reports on results of a first experiment conducted to evaluate the mobile application. The main research questions…

  1. Acquisition of flexible cystoscopy skills on a virtual reality simulator by experts and novices

    NARCIS (Netherlands)

    Schout, Barbara M. A.; Muijtjens, Arno M. M.; Hendrikx, Ad J. M.; Ananias, Hildo J. K.; Dolmans, Valerie E. M. G.; Scherpbier, Albert J. J. A.; Bemelmans, Bart L. H.

    OBJECTIVE To assess the construct validity of the URO MentorTM (Simbionix Corp., Cleveland, OH, USA) virtual reality training model for several variables of skills training in cysto-urethroscopy, addressing two research questions: (i) Does training on the URO Mentor significantly improve novices'

  2. Transforming Research Management Systems at Mayo Clinic (United States)

    Smith, Steven C.; Gronseth, Darren L.


    In order for research programs at academic medical centers and universities to survive and thrive in the increasingly challenging economic, political and regulatory environment, successful transformation is extremely important. Transformation and quality management techniques are increasingly well established in medical practice organizations. In…

  3. Comparing experts and novices in Martian surface feature change detection and identification (United States)

    Wardlaw, Jessica; Sprinks, James; Houghton, Robert; Muller, Jan-Peter; Sidiropoulos, Panagiotis; Bamford, Steven; Marsh, Stuart


    Change detection in satellite images is a key concern of the Earth Observation field for environmental and climate change monitoring. Satellite images also provide important clues to both the past and present surface conditions of other planets, which cannot be validated on the ground. With the volume of satellite imagery continuing to grow, the inadequacy of computerised solutions to manage and process imagery to the required professional standard is of critical concern. Whilst studies find the crowd sourcing approach suitable for the counting of impact craters in single images, images of higher resolution contain a much wider range of features, and the performance of novices in identifying more complex features and detecting change, remains unknown. This paper presents a first step towards understanding whether novices can identify and annotate changes in different geomorphological features. A website was developed to enable visitors to flick between two images of the same location on Mars taken at different times and classify 1) if a surface feature changed and if so, 2) what feature had changed from a pre-defined list of six. Planetary scientists provided ;expert; data against which classifications made by novices could be compared when the project subsequently went public. Whilst no significant difference was found in images identified with surface changes by expert and novices, results exhibited differences in consensus within and between experts and novices when asked to classify the type of change. Experts demonstrated higher levels of agreement in classification of changes as dust devil tracks, slope streaks and impact craters than other features, whilst the consensus of novices was consistent across feature types; furthermore, the level of consensus amongst regardless of feature type. These trends are secondary to the low levels of consensus found, regardless of feature type or classifier expertise. These findings demand the attention of researchers who

  4. Social phobia: research and clinical practice. (United States)

    Alnaes, R


    Social phobia is a pervasive pattern of social inhibition, feelings of inadequacy, and hypersensitivity, occurring in about 18% of the clinical population. Despite good results with cognitive-behavioural treatment, social phobia seems to be a chronic disorder with several complications. The author describes an analysis of a divorced woman who was exposed to an early premature sexual seduction by her father, abruptly terminated because of an accident. The loss of the father was repaired by a delusional system as defence against the re-emergence of a catastrophic situation. Her compulsion to repeat the traumatic situation was seen in symbolic attempts to reproduce the lost experience of forbidden pleasure with other men, ending in hopeless affairs. According to DSM-IV the patient had-besides social phobia-several personality disturbances, clinically manifested by weak ego boundaries, an unclear identity, and low self-esteem. Cognitive-behavioural therapy and psychopharmaca were without any effect. The childhood experiences were repeated in the context of the analysis and worked through, especially the pre-oedipal and oedipal conflicts. Important repeating themes were "crime", guilt, and punishment. After 3 years of analysis it was possible for the patient to expose herself to anxiety-producing situations with less symptoms. It was possible for her to withdraw the projections and take more responsibility for the unconscious sexual and aggressive impulses. At the 5-year follow-up her satisfactions had become more realistic and she became involved in a positive relationship.

  5. Enrolling Minority and Underserved Populations in Cancer Clinical Research. (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


    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.

  6. AIDS--Challenges to Basic and Clinical Biomedical Research. (United States)

    Fauci, Anthony S.


    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)

  7. Legitimating Clinical Research in the Study of Organizational Culture. (United States)

    Schein, Edgar H.


    Argues that traditional research model used in industrial-organizational psychology is not useful in understanding deeper dynamics of organizations, especially those phenomena labeled as "cultural." Contends that use of data obtained during clinical and consulting work should be legitimated as valid research data. Spells out clinical model and…

  8. Time distortion for expert and novice online game players. (United States)

    Rau, Pei-Luen Patrick; Peng, Shu-Yun; Yang, Chin-Chow


    Online game addiction is a new mental disorder. This disorder is difficult to describe because of its comprehensive nature. Many online game players have problems controlling their playing time. They cannot stop playing a game that they enjoy. This research surveyed the past literature on "flow" and time disorder theory. A time distortion experiment was conducted. This research invited 64 children, teenagers, and young adults to investigate player skill and playing time effects on online game break-off. The playing experience and degree of time distortion were measured and analyzed. The results showed that both novice and expert online game players were subject to time distortion. The participants had difficulty breaking off from the game without intrusion by others in the real world. This research also suggests eight questions for self-evaluation for online game addiction.

  9. How Do Novice and Expert Learners Represent, Understand, and Discuss Geologic Time? (United States)

    Layow, Erica Amanda

    This dissertation examined the representations novice and expert learners constructed for the geologic timescale. Learners engaged in a three-part activity. The purpose was to compare novice learners' representations to those of expert learners. This provided insight into the similarities and differences between their strategies for event ordering, assigning values and scale to the geologic timescale model, as well as their language and practices to complete the model. With a qualitative approach to data analysis informed by an expert-novice theoretical framework grounded in phenomenography, learner responses comprised the data analyzed. These data highlighted learners' metacognitive thoughts that might not otherwise be shared through lectures or laboratory activities. Learners' responses were analyzed using a discourse framework that positioned learners as knowers. Novice and expert learners both excelled at ordering and discussing events before the Phanerozoic, but were challenged with events during the Phanerozoic. Novice learners had difficulty assigning values to events and establishing a scale for their models. Expert learners expressed difficulty with determining a scale because of the size of the model, yet eventually used anchor points and unitized the model to establish a scale. Despite challenges constructing their models, novice learners spoke confidently using claims and few hedging phrases indicating their confidence in statements made. Experts used more hedges than novices, however the hedging comments were made about more complex conceptions. Using both phenomenographic and discourse analysis approaches for analysis foregrounded learners' discussions of how they perceived geologic time and their ways of knowing and doing. This research is intended to enhance the geoscience community's understanding of the ways novice and expert learners think and discuss conceptions of geologic time, including the events and values of time, and the strategies used

  10. Progress in clinical research of asteroid hyalosis

    Directory of Open Access Journals (Sweden)

    Xiao-Xue Liu


    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.

  11. The Microcomputer in the Clinical Nursing Research Unit (United States)

    Schwirian, Patricia M.; Byers, Sandra R.


    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.

  12. Data management by using R: big data clinical research series. (United States)

    Zhang, Zhongheng


    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.

  13. Novice supervisors' tasks and training - a descriptive study

    DEFF Research Database (Denmark)

    Nielsen, Jan; Jacobsen, Claus H.; Mathiesen, Birgit Bork

    development, experience, and practice. In this presentation we focus on the tasks and training of the respondents as novice supervisors. The results show, that a majority of novice supervisors were confronted with complicated jobs, e.g., group, internal and interdisciplinary supervision, but were not prepared......There is a lack of data on the influence of the debut as a supervisor on the later career. However, extrapolating data from therapist development, we assume that the first years as novice supervisor are important for the following career as supervisor in particular. The first job as novice......, i.e. trained, prior to these tasks. These findings imply that more training is needed for novice supervisors. Preferably, this training should be introduced before, or at least parallel to, the first supervisor tasks, preparing the novice supervisors for the often complicated tasks they are meeting....

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

    LENUS (Irish Health Repository)

    Desmond, A


    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.

  15. Integration of clinical research documentation in electronic health records. (United States)

    Broach, Debra


    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.

  16. Strategies to successfully recruit and engage clinical nurses as participants in qualitative clinical research. (United States)

    Coyne, Elisabeth; Grafton, Eileen; Reid, Alayne


    Research conducted in the clinical area promotes the delivery of evidence-based patient care. Involving nurses as participants in research is considered essential to link patient care with evidence-based interventions. However recruitment is influenced by nurses' competing demands and understanding engagement strategies may assist future research. This reflective analysis aimed to understand influencing factors and strategies that support successful recruitment nurses in clinical research. A reflective analysis of research notes and focus group data from research with oncology nurses was completed. This research identified that gaining support from key staff, understanding work constraints and developing a rapport with nurses is important. Establishing clear relevance and benefits of the research and being flexible with research requirements enabled nurses to participate in the research. Clear information and a willingness to accommodate the demands and dynamic nature of the environment, ensures ongoing support and engagement of nurses in the clinical setting as participants in research.

  17. Use of analogies by novice and experienced design engineers

    DEFF Research Database (Denmark)

    Ahmed, Saeema; Christensen, Bo T.


    industry. The findings indicate a significant difference in both the functions and reasoning by novices and experienced designers. Novices were found to predominantly transfer information without explicit reference to design issues, whereas experienced designers tended to either solve or identify problems....... Experienced designers were found to reason about the function of a component and to some degree the predicted behaviour of the component, whereas the novices seem to lack such reasoning processes....

  18. A metadata schema for data objects in clinical research. (United States)

    Canham, Steve; Ohmann, Christian


    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.

  19. Knowledge Creation in Clinical Product Development Management Research

    DEFF Research Database (Denmark)

    Karlsson, Christer; Sköld, Martin


    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 that on t......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...

  20. Clinical Research Nursing: A Critical Resource in the National Research Enterprise (United States)

    Hastings, Clare E.; Fisher, Cheryl A.; McCabe, Margaret A.


    Translational clinical research has emerged as an important priority for the national research enterprise, with a clearly stated mandate to deliver prevention strategies, treatments and cures based on scientific innovations faster to the public. Within this national effort, a lack of consensus persists concerning the need for clinical nurses with expertise and specialized training in study implementation and the delivery of care to research participants. This paper reviews efforts to define and document the role of practicing nurses in implementing studies and coordinating clinical research in a variety of clinical settings and differentiates this clinical role from the role of nurses as scientists and principal investigators. We propose an agenda for building evidence that having nurses provide and coordinate study treatments and procedures can potentially improve research efficiency, participant safety, and the quality of research data. We also provide recommendations for the development of the emerging specialty of clinical research nursing. PMID:22172370

  1. Participation in HIV research: the importance of clinic contact factors. (United States)

    Worthington, Catherine A; Gill, M John


    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.

  2. [Application of Delphi method in traditional Chinese medicine clinical research]. (United States)

    Bi, Ying-fei; Mao, Jing-yuan


    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.

  3. Integrating Bioethics into Clinical and Translational Science Research: A Roadmap (United States)

    Shapiro, Robyn S.; Layde, Peter M.


    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

  4. 76 FR 24974 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and... (United States)


    ... Science Research and Development Services Scientific Merit Review Board; Notice of Meeting Amendment The... and Clinical Science Research and Development Services Scientific Merit Review Board have been..., behavioral and clinical science research. The panel meetings will be open to the public for approximately one...

  5. 76 FR 79273 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and... (United States)


    ... Science Research and Development Services Scientific Merit Review Board Panel for Eligibility, Notice of... and Clinical Science Research and Development Services Scientific Merit Review Board will meet on... medical specialties within the general areas of biomedical, behavioral, and clinical science research. The...

  6. Clinical Research Informatics for Big Data and Precision Medicine. (United States)

    Weng, C; Kahn, M G


    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.

  7. Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example. (United States)

    Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda


    The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

  8. Comparative audit of clinical research in pediatric neurology. (United States)

    Al-Futaisi, Amna; Shevell, Michael


    Clinical research involves direct observation or data collection on human subjects. This study was conducted to evaluate the profile of pediatric neurology clinical research over a decade. Trends in pediatric neurology clinical research were documented through a systematic comparative review of articles published in selected journals. Eleven journals (five pediatric neurology, three general neurology, three general pediatrics) were systematically reviewed for articles involving a majority of human subjects less than 18 years of age for the years 1990 and 2000. Three hundred thirty-five clinical research articles in pediatric neurology were identified in the 11 journals for 1990 and 398 for 2000, a 19% increase. A statistically significant increase in analytic design (21.8% vs 39.5%; P = .01), statistical support (6% vs 16.6%; P neurology over a decade. Trends apparently suggest a more rigorous approach to study design and investigation in this field.

  9. Cyclotrons for clinical and biomedical research with PET

    International Nuclear Information System (INIS)

    Wolf, A.P.


    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

  10. A proposed clinical research support career pathway for noninvestigators. (United States)

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


    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.

  11. Sex differences in health research and clinical guideline development

    NARCIS (Netherlands)

    Keuken, D.G.


    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

  12. Radioactive isotopes in clinical medicine and research. Abstracts

    International Nuclear Information System (INIS)


    The review on the International Symposium on radioactive isotopes in clinical medicine and research in Bad Hofgastein, Austria, 9-12 January 2008, contains 42 papers and 29 poster contributions on the following topics: radiopharmaceutical sciences; radiopharmaceutical sciences in oncology and cardiology; therapy; endocrinology; molecular imaging; clinical PET; physics: image processing; instrumentation, neurology, psychiatry

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

    NARCIS (Netherlands)

    Preminger, G.M.; Alken, P.; Habuchi, T.; Wijkstra, H.; Skolarikos, A.; Yin, C.-J.


    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

  14. Key factors in children's competence to consent to clinical research

    NARCIS (Netherlands)

    Hein, Irma M.; Troost, Pieter W.; Lindeboom, Robert; Benninga, Marc A.; Zwaan, C. Michel; van Goudoever, Johannes B.; Lindauer, Ramón J. L.


    Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors

  15. The National Institute of Dental Research Clinical Dental Staff Fellowship. (United States)

    Baum, Bruce J.; And Others


    A program in one of the National Institutes of Health offers clinical training fellowships as a means of training potential dental school faculty by providing both unique clinical skills and high-quality research experience. The program was developed in response to a perceived need for change in academic dentistry. (MSE)

  16. Radioactive isotopes in clinical medicine and research. Abstracts

    Energy Technology Data Exchange (ETDEWEB)



    The review on the International Symposium on radioactive isotopes in clinical medicine and research in Bad Hofgastein, Austria, 9-12 January 2008, contains 42 papers and 29 poster contributions on the following topics: radiopharmaceutical sciences; radiopharmaceutical sciences in oncology and cardiology; therapy; endocrinology; molecular imaging; clinical PET; physics: image processing; instrumentation, neurology, psychiatry.

  17. Infrastructure resources for clinical research in amyotrophic lateral sclerosis. (United States)

    Sherman, Alexander V; Gubitz, Amelie K; Al-Chalabi, Ammar; Bedlack, Richard; Berry, James; Conwit, Robin; Harris, Brent T; Horton, D Kevin; Kaufmann, Petra; Leitner, Melanie L; Miller, Robert; Shefner, Jeremy; Vonsattel, Jean Paul; Mitsumoto, Hiroshi


    Clinical trial networks, shared clinical databases, and human biospecimen repositories are examples of infrastructure resources aimed at enhancing and expediting clinical and/or patient oriented research to uncover the etiology and pathogenesis of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative disease that leads to the paralysis of voluntary muscles. The current status of such infrastructure resources, as well as opportunities and impediments, were discussed at the second Tarrytown ALS meeting held in September 2011. The discussion focused on resources developed and maintained by ALS clinics and centers in North America and Europe, various clinical trial networks, U.S. government federal agencies including the National Institutes of Health (NIH), the Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention (CDC), and several voluntary disease organizations that support ALS research activities. Key recommendations included 1) the establishment of shared databases among individual ALS clinics to enhance the coordination of resources and data analyses; 2) the expansion of quality-controlled human biospecimen banks; and 3) the adoption of uniform data standards, such as the recently developed Common Data Elements (CDEs) for ALS clinical research. The value of clinical trial networks such as the Northeast ALS (NEALS) Consortium and the Western ALS (WALS) Consortium was recognized, and strategies to further enhance and complement these networks and their research resources were discussed.

  18. Features of TMR for a Successful Clinical and Research Database


    Pryor, David B.; Stead, William W.; Hammond, W. Edward; Califf, Robert M.; Rosati, Robert A.


    A database can be used for clinical practice and for research. The design of the database is important if both uses are to succeed. A clinical database must be efficient and flexible. A research database requires consistent observations recorded in a format which permits complete recall of the experience. In addition, the database should be designed to distinguish between missing data and negative responses, and to minimize transcription errors during the recording process.

  19. The effect of feedback on attitudes toward cellular phone use while driving: a comparison between novice and experienced drivers. (United States)

    Wang, Ying; Zhang, Wei; Reimer, Bryan; Lavallière, Martin; Lesch, Mary F; Horrey, William J; Wu, Su


    novices. Additional research is needed to better tailor this education method toward novice drivers. Simulation-based participative education approach through feedback needs to be better tailored toward novice drivers.

  20. Characterizing novice-expert differences in macrocognition: an exploratory study of cognitive work in the emergency department. (United States)

    Schubert, Christiane C; Denmark, T Kent; Crandall, Beth; Grome, Anna; Pappas, James


    multiple patients, novices have difficulty seeing and maintaining the "big picture." Novice physicians use sense-making styles that differ from those of experts. Training novices to respond to the high cognitive demand of complex environments early in their careers requires instructional modalities that not only increase their knowledge base but also accelerate the integration of knowledge and practice. Simulation and custom-designed avatar-mediated virtual worlds are a promising new technology that may facilitate such training. Future research should expand on the results of this study through the use of larger sample sizes and interviews conducted at multiple sites to increase generalizability. Copyright © 2012. Published by Mosby, Inc.

  1. Implementing Clinical Research Using Factorial Designs: A Primer. (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


    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.

  2. Clinical diabetes research using data mining: a Canadian perspective. (United States)

    Shah, Baiju R; Lipscombe, Lorraine L


    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.

  3. Beginning Python from novice to professional

    CERN Document Server

    Hetland, Magnus Lie


    ""Beginning Python: From Novice to Professional"" is the most comprehensive book on the Python ever written. Based on ""Practical Python,"" this newly revised book is both an introduction and practical reference for a swath of Python-related programming topics, including addressing language internals, database integration, network programming, and web services. Advanced topics, such as extending Python and packaging/distributing Python applications, are also covered. Ten different projects illustrate the concepts introduced in the book. You will learn how to create a P2P file-sharing applicati

  4. Utilizing a logic model to identify clinical research problems: a lesson from philosophy of science

    Directory of Open Access Journals (Sweden)

    Collins CR


    Full Text Available Cynthia R Collins School of Nursing, College of Social Sciences, Loyola University, New Orleans, LA, USA Abstract: Communication and decision making in the health care workplace often involve finding solutions to ill-structured problems in uncertain, dynamic environments influenced by the competing interests of multiple stakeholders. In this environment, doctoral-prepared nurses who practice as administrators, policy makers, or advanced practice practitioners are often compelled to make important decisions based upon evaluating the merit of colleagues’ proposals against some desired organizational or population outcome. Of equal importance is the nurse leader’s own capacity to construct a compelling argument or proposal that will drive the organization forward to meet the evolving needs for quality health care. Where do we learn the skills necessary to foster this kind of critical thinking in our professional communications? The author suggests that one teaching–learning approach can be found through the thoughtful application of the work of British philosopher Steven Toulmin. Toulmin defined a model for both the analysis and derivation of logical arguments or proposals that can be readily learned and applied for use in health care systems. This model posits that a substantive argument or claim can be evaluated based on the assumptions it presumes (warrants and the strength of the evidence base (backing. Several of the social science professions have adapted Toulmin’s model to generate analysis and creative solutions to complex or emergent problems. The author proposes that an application of this model be included in the pedagogy of doctoral level Philosophy of Science or Nursing Theory courses. The Toulmin process often provides the doctoral student or novice researcher with their first real learning experience in defining the scope and inherent challenges of framing a clinical issue to be the focus of their scholarly translational

  5. Problem-solving strategies in psychiatry: differences between experts and novices in diagnostic accuracy and reasoning. (United States)

    Gabriel, Adel; Violato, Claudio


    The purpose of this study was to examine and compare diagnostic success and its relationship with the diagnostic reasoning process between novices and experts in psychiatry. Nine volunteers, comprising five expert psychiatrists and four clinical clerks, completed a think-aloud protocol while attempting to make a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of a selected case with both Axis I and Axis III diagnoses. Expert psychiatrists made significantly more successful diagnoses for both the primary psychiatric and medical diagnoses than clinical clerks. Expert psychiatrists also gave fewer differential options. Analyzing the think-aloud protocols, expert psychiatrists were much more organized, made fewer mistakes, and utilized significantly less time to access their knowledge than clinical clerks. Both novices and experts seemed to use the hypothetic-deductive and scheme-inductive approaches to diagnosis. However, experts utilized hypothetic-deductive approaches significantly more often than novices. The hypothetic-deductive diagnostic strategy was utilized more than the scheme-inductive approach by both expert psychiatrists and clinical clerks. However, a specific relationship between diagnostic reasoning and diagnostic success could not be identified in this small pilot study. The author recommends a larger study that would include a detailed analysis of the think-aloud protocols.

  6. The UK clinical research network - has it been a success for dermatology clinical trials?


    Charlesworth Lisa; Perdue Jo; Foster Katharine; Koller Karin; Thomas Kim S; Chalmers Joanne R


    Abstract Background Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). Methods This report evaluates the imp...

  7. Radiology image perception and observer performance: How does expertise and clinical information alter interpretation? Stroke detection explored through eye-tracking (United States)

    Cooper, Lindsey; Gale, Alastair; Darker, Iain; Toms, Andoni; Saada, Janak


    Historically, radiology research has been dominated by chest and breast screening. Few studies have examined complex interpretative tasks such as the reading of multidimensional brain CT or MRI scans. Additionally, no studies at the time of writing have explored the interpretation of stroke images; from novices through to experienced practitioners using eye movement analysis. Finally, there appears a lack of evidence on the clinical effects of radiology reports and their influence on image appraisal and clinical diagnosis. A computer-based, eye-tracking study was designed to assess diagnostic accuracy and interpretation in stroke CT and MR imagery. Eight predetermined clinical cases, five images per case, were presented to participants (novices, trainee, and radiologists; n=8). The presence or absence of abnormalities was rated on a five-point Likert scale and their locations reported. Half cases of the cases were accompanied by clinical information; half were not, to assess the impact of information on observer performance. Results highlight differences in visual search patterns amongst novice, trainee and expert observers; the most marked differences occurred between novice readers and experts. Experts spent more time in challenging areas of interest (AOI) than novices and trainee, and were more confident unless a lesion was large and obvious. The time to first AOI fixation differed by size, shape and clarity of lesion. 'Time to lesion' dropped significantly when recognition appeared to occur between slices. The influence of clinical information was minimal.

  8. Administrative Context and Novice Teacher-Mentor Interactions (United States)

    Pogodzinski, Ben


    Purpose: Mentoring can improve novice teacher effectiveness and reduce teacher attrition, yet the depth and breadth of mentoring can vary greatly within and between schools. The purpose of this paper is to identify the extent to which a school's administrative context is associated with the focus and frequency of novice teacher-mentor…

  9. Effects of Disclosing Financial Interests on Attitudes Toward Clinical Research (United States)

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


    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

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

    Directory of Open Access Journals (Sweden)

    Jeanne Dalen


    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

  11. US-LA CRN Clinical Cancer Research in Latin America (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).

  12. Feasibility of Conducting Autism Biomarker Research in the Clinical Setting. (United States)

    Sices, Laura; Pawlowski, Katherine; Farfel, Laura; Phillips, Deirdre; Howe, Yamini; Cochran, David M; Choueiri, Roula; Forbes, Peter W; Brewster, Stephanie J; Frazier, Jean A; Neumeyer, Ann; Bridgemohan, Carolyn


    Recruitment and completion of research activities during regular clinical care has the potential to increase research participation in complex neurodevelopmental disorders. We evaluated the feasibility, and effect on clinical care, of conducting biomarker research within a subspecialty clinical visit for autism spectrum disorder (ASD). Children, aged 5 to 10 years, were recruited by providers in ASD clinics at 5 institutions. Biomarkers collected were growth measurements, head circumference, neurologic and dysmorphology examinations, digit ratio (2D:4D) measurement, and platelet serotonin and urinary melatonin sulfate excretion levels. Parents completed the Aberrant Behavior Checklist-Community and a medical/demographic questionnaire. Cognitive level was abstracted from the medical record. Parents and clinicians completed surveys on the effect of the study on the clinical visit. Eighty-three children and their caregivers participated. Factors limiting participation included difficulty reaching families by phone and parent concern about the study blood draw requirement. All children completed at least 4 of 7 planned research activities. Demographic factors, educational placement, and child behavior were not associated with completion of study activities. Lower nonverbal cognitive function was weakly associated with fewer activities completed. Forty-four percent of clinicians reported an effect of the research study on the clinical visit. However, neither parent-reported nor clinician-reported effect was associated with the degree of study activity completion. Recruiting study participants in the context of scheduled ASD clinical visits required significant effort. However, once recruited, participants completed most study activities, regardless of behavioral symptom severity. Research activities did not adversely affect the clinical visit.

  13. Clinical Research Environment in India: Challenges and Proposed Solutions. (United States)

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


    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 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.

  14. A narrative inquiry into novice science mentor teachers' mentoring practices (United States)

    Naseem, Samina

    Many teacher education programs hire new mentors every year to work with their student teacher population. The literature about teacher mentoring suggests the importance of relevant and ongoing professional development (PD) for teacher mentors at all levels. However, it is much more commonly the case that most teacher mentors volunteer and do not have access to PD. Past research about mentoring provides a descriptive sense of the practices of experienced mentors, especially within a PD context, but little is known about how novice mentors, who are mentoring for the first or the second time, with no prior PD related to mentoring articulate their work as mentors. Using the telling form of narrative inquiry, my study documented how four novice science mentors (NSMs) who had no prior mentoring-related PD articulated the work of mentoring through the stories they told about their past experiences as learners and teachers. The term learner included experiences that the NSMs had before school through K-12 and in their teacher education programs. The experiences as a teacher referred to NSMs' in-service experiences -- teaching, coaching, and mentoring (if any). Each NSM was interviewed once a month for a period of five months. The interviews captured experiences of the NSMs since their childhood to present day experiences as teachers to summarize the experiences that informed their current mentoring practices; to document salient mentoring practices they employed; to identify sources and factors that shaped those practices, and to understand mentoring from mentor teachers' perspectives. Clandinin and Connelly's (2000) three commonplaces (temporality- sociality- place ) framework was used for structuring interview questions and analyzing data. The NSMs employed number of practices discussed in the literature. The study found that the most influential life experiences were upbringing, student teaching, teaching, prior mentoring, and coaching. By taking temporality into

  15. In Defense of a Social Value Requirement for Clinical Research. (United States)

    Wendler, David; Rid, Annette


    Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. © 2017 John Wiley & Sons Ltd.

  16. MedAustron – Non-Clinical Research Opportunities

    International Nuclear Information System (INIS)

    Schreiner, T.


    MedAustron is a synchrotron based light-ion beam therapy centre for cancer treatment as well as for clinical and non-clinical research, currently in the construction phase in Wiener Neustadt. Whilst the choice of basic machine parameters was driven by medical requirements, the accelerator complex design was also optimised to offer flexibility for research operation. The potential of the synchrotron is being exploited to increase the maximum proton energy far beyond the medical needs to up to 800 MeV, for experimental physics applications, mainly in the areas of proton scattering and detector research. The accelerator layout allows for the installation of up to four ion source-spectrometer units, to provide various ion types besides the clinical used protons and carbon ions. To decouple research and medical operation, a dedicated irradiation room for non-clinical research was included providing two isocentres for the installation of different experiments. This presentation provides a status overview over the whole project and highlights the non-clinical research opportunities at MedAustron. (author)

  17. 'Nursing research culture' in the context of clinical nursing practice

    DEFF Research Database (Denmark)

    Bøttcher Berthelsen, Connie; Hølge-Hazelton, Bibi


    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......Aim To report an analysis of the concept of nursing research culture in the context of clinical nursing practice. Background Nursing research culture should be valued for its contribution to improving patient care and should be considered as a routine hospital activity. However, the demand......'s eight-step framework for concept analysis. Results Five defining attributes of nursing research culture in the context of clinical nursing practice were identified: strong monodisciplinary nursing professionalism, academic thinking and socialization, research use as a part of daily nursing practice...

  18. Guidance for Researchers Developing and Conducting Clinical Trials in Practice-based Research Networks (PBRNs) (United States)

    Dolor, Rowena J.; Schmit, Kristine M.; Graham, Deborah G.; Fox, Chester H.; Baldwin, Laura Mae


    Background There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Methods Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. Results The “Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks” offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Conclusion Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams. PMID:25381071

  19. The UK clinical research network--has it been a success for dermatology clinical trials? (United States)

    Thomas, Kim S; Koller, Karin; Foster, Katharine; Perdue, Jo; Charlesworth, Lisa; Chalmers, Joanne R


    Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks) using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales), and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

  20. Danish research-active clinical nurses overcome barriers in research utilization. (United States)

    Adamsen, Lis; Larsen, Kristian; Bjerregaard, Lene; Madsen, Jan K


    The aim of this study was to examine whether there was a difference between clinical nurses who were research-active, and clinical nurses who were nonresearch-active in utilization of research. A further aim was to identify the most significant barriers faced by a group of Danish clinical nurses in their use of research. Discrepancy between the improved quality of research results and the lack of implementing them was the starting point for a series of studies which showed the types of barriers clinical nurses found especially cumbersome when applying the research results of other researchers. This study investigates whether the clinical nurses' own engagement in research had any impact on their perception of research utilization. The study had an exploratory and descriptive design. Seventy-nine Danish clinical nurses participated and semi-structured interviewing was used as the research method. There was a statistically significant difference between the research-active and nonresearch-active nurses on various variables. The study showed that, to a larger extent, research-active nurses used evidence-based knowledge and were generally more internationally orientated. Furthermore, two important barriers for research utilization were identified by all 79 clinical nurses included in the study, i.e. 90% of the nurses explained that the quantity of research results was overwhelming, and 75% of them found that they were unable to evaluate the quality of the research. Clinical nurses, who were research-active themselves, experienced more success in overcoming some of the barriers, which existed in applying research to practice. The research potential found amongst clinical nurses in Denmark needed to be further supported through training and guidance in research methodology, establishing introductory stipends and part-time research positions. By doing so, some of the barriers affecting research utilization and the so-called theory-practice gap might be reduced. Further

  1. The STAR Data Reporting Guidelines for Clinical High Altitude Research. (United States)

    Brodmann Maeder, Monika; Brugger, Hermann; Pun, Matiram; Strapazzon, Giacomo; Dal Cappello, Tomas; Maggiorini, Marco; Hackett, Peter; Bärtsch, Peter; Swenson, Erik R; Zafren, Ken


    Brodmann Maeder, Monika, Hermann Brugger, Matiram Pun, Giacomo Strapazzon, Tomas Dal Cappello, Marco Maggiorini, Peter Hackett, Peter Baärtsch, Erik R. Swenson, Ken Zafren (STAR Core Group), and the STAR Delphi Expert Group. The STARdata reporting guidelines for clinical high altitude research. High AltMedBiol. 19:7-14, 2018. The goal of the STAR (STrengthening Altitude Research) initiative was to produce a uniform set of key elements for research and reporting in clinical high-altitude (HA) medicine. The STAR initiative was inspired by research on treatment of cardiac arrest, in which the establishment of the Utstein Style, a uniform data reporting protocol, substantially contributed to improving data reporting and subsequently the quality of scientific evidence. The STAR core group used the Delphi method, in which a group of experts reaches a consensus over multiple rounds using a formal method. We selected experts in the field of clinical HA medicine based on their scientific credentials and identified an initial set of parameters for evaluation by the experts. Of 51 experts in HA research who were identified initially, 21 experts completed both rounds. The experts identified 42 key parameters in 5 categories (setting, individual factors, acute mountain sickness and HA cerebral edema, HA pulmonary edema, and treatment) that were considered essential for research and reporting in clinical HA research. An additional 47 supplemental parameters were identified that should be reported depending on the nature of the research. The STAR initiative, using the Delphi method, identified a set of key parameters essential for research and reporting in clinical HA medicine.

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

    Directory of Open Access Journals (Sweden)

    Sami F Shaban


    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

  3. Exploring the value of qualitative research films in clinical education. (United States)

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


    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.

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


    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.

  5. Clinical nursing and midwifery research: grey literature in African countries. (United States)

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


    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

  6. Characteristics desired in clinical data warehouse for biomedical research. (United States)

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


    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.

  7. The Ethics of Clinical Trials Research in Severe Mood Disorders. (United States)

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


    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.

  8. More ethical and more efficient clinical research: multiplex trial design. (United States)

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


    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.

  9. Radioactive isotopes in clinical medicine and research. Abstracts

    International Nuclear Information System (INIS)


    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)

  10. [Conflicts of interests in clinical research in primary health care]. (United States)

    González-de Paz, L; Navarro-Rubio, M D; Sisó-Almirall, A


    Conflicts of interests between professionals and patients in biomedical research, is an ethical problem. None of the laws in Spain mention whether the clinical researcher has to clarify to participants the reasons why it proposes them to participate in a clinical trial. In this article, conflicts of interests in research are discussed in the context of primary healthcare. In this area conflicts of interests might alter the confidence between patients and healthcare professionals. Finally, we suggest some practical strategies that can help participants make the decision to participate in a clinical trial more willingly and freely. Copyright © 2013 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España. All rights reserved.

  11. Common data elements for spinal cord injury clinical research

    DEFF Research Database (Denmark)

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


    Institutes of Health. SETTING: International Working Groups. METHODS: Nine working groups composed of international experts reviewed existing CDEs and instruments, created new elements when needed and provided recommendations for SCI clinical research. The project was carried out in collaboration...... of CDEs can facilitate SCI clinical research and trial design, data sharing and retrospective analyses. Continued international collaboration will enable consistent data collection and reporting, and will help ensure that the data elements are updated, reviewed and broadcast as additional evidence......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...

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

    CERN Document Server

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


    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...

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

  14. Platelet Immunology in China: Research and Clinical Applications. (United States)

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


    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.

  15. Basic and clinical research advances in ischemic stroke

    Directory of Open Access Journals (Sweden)

    Yuan-yuan MA


    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.

  16. India's growing clinical research sector: opportunity for global companies. (United States)

    Varawalla, Nermeen


    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.

  17. Semantic processing of EHR data for clinical research. (United States)

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


    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.

  18. Bioethical Issues in Conducting Pediatric Dentistry Clinical Research. (United States)

    Garrocho-Rangel, Arturo; Cerda-Cristerna, Bernardino; Pozos-Guillen, Amaury

    Pediatric clinical research on new drugs and biomaterials involves children in order to create valid and generalizable knowledge. Research on vulnerable populations, such as children, is necessary but only admissible when researchers strictly follow methodological and ethical standards, together with the respect to human rights; and very especially when the investigation cannot be conducted with other population or when the potential benefits are specifically for that age group. Clinical research in Pediatric Dentistry is not an exception. The aim of the present article was to provide the bioethical principles (with respect to the child/parents' autonomy, benefit/risk analysis, and distributive justice), and recommendations, including informed consent, research ethics committees, conflict of interest, and the "equipoise" concept. Current and future worldwide oral health research in children and adolescents must be conducted incorporating their perspectives in the decision-making process as completely as possible. This concept must be carefully considered when a dental clinical study research is going to be planned and conducted, especially in the case of randomized controlled trials, in which children will be recruited as participants.

  19. Closing the Gap between Research Evidence and Clinical Practice: Jordanian Nurses' Perceived Barriers to Research Utilisation (United States)

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


    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…

  20. Advance directives in dementia research: The opinions and arguments of clinical researchers − an empirical study

    NARCIS (Netherlands)

    K.R. Jongsma (Karin); S. van de Vathorst (Suzanne)


    textabstractIn order to discover an effective treatment for dementia it is necessary to include dementia patients in clinical research trials. Dementia patients face an increased risk to lose the capacity to consent to research participation, and research possibilities with incompetent participants

  1. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls. (United States)

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


    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.

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

  3. Colon cleansing protocol in children: research conditions vs. clinical practice. (United States)

    Elitsur, Yoram; Balfaqih, Yaslam; Preston, Deborah


     Colon preparation rates are the limiting factor for a successful diagnostic colonoscopy in children. Different colon cleansing protocols have been published for use in children. Unfortunately, the applicability of those published research protocols has not been formally evaluated in routine clinical practice. We investigated the success rate of our previously published colon cleansing protocol as utilized in our clinical practice.  This was a retrospective study. In the clinical practice, the colon cleansing protocol included PEG-3350 at a dose of 2 g/kg/day plus Dulcolax (Bisacodyl, Boehringer Ingelheim, TX USA) 5 mg/day for 2 days. Adequate colon preparation was graded between 1 - 5, as previously described, and grade ≥ 4.0 was considered an adequate preparation. Patients were instructed to complete a questionnaire that included PEG-3350 dose, number of stools per day, consistency of each stool, and side effects (vomiting, abdominal pain). Clinical and endoscopic results were compared between the protocol under research conditions and routine practice.  The success rate of the colon preparation in our clinical practice was similar to the results observed under our research protocol (75 % vs. 73.6 %). Moreover, the total number of stools, stool consistency, and the intubation rate of the terminal ileum were also similar. We concluded, that in our experience, the colon cleansing protocol used under research conditions was effective and appropriate for use in routine clinical practice.  We recommend testing each new protocol under the routine conditions of clinical practice to confirm its applicability for general practitioners.

  4. Reproducibility of clinical research in critical care: a scoping review. (United States)

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


    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

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

    Directory of Open Access Journals (Sweden)

    Apolone Giovanni


    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

  6. 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


    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...... 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...


    DEFF Research Database (Denmark)

    Dorst, Kees; Hansen, Claus Thorp


    In their ICED09 paper ‘Problem formulation as a discursive activity’, the authors have used an extensive educational case study to explore a framework for describing design as a discursive activity, centered around the paradoxical nature of the problem situation. The ‘working definition’ for para......In their ICED09 paper ‘Problem formulation as a discursive activity’, the authors have used an extensive educational case study to explore a framework for describing design as a discursive activity, centered around the paradoxical nature of the problem situation. The ‘working definition...... at play in a design situation, and extract themes that can lead to reformulation of the problem as well as the creation of innovative solutions. This behaviour is compared to the ways of working of novice designers (students) in the original case study....

  8. A cohort of novice Danish science teachers

    DEFF Research Database (Denmark)

    Nielsen, Birgitte Lund


    A survey on science background and argumentation about science teaching was conducted on a local cohort of newly qualified Danish science teachers. The survey was administered before the novice teachers began their first jobs in primary and lower secondary schools and focused on their reflections...... on specific scenarios of science teaching and themselves as teachers in various science fields. Three areas of concern were identified:There was evidence of reflection upon and argumentation for the practice of science teaching being student centered, but many respondents showed a tendency to focus...... on students' activities as a goal in themselves, few considered what the students learned through the activities. Results furthermore suggest that the teachers' own assessment of their subject matter knowledge in the physics field may, for a large subgroup in the cohort, affect their approach to teaching...

  9. Bulls and bears: the stock market and clinical pathology research. (United States)

    Khong, T Y


    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.

  10. Digital pathology in nephrology clinical trials, research, and pathology practice. (United States)

    Barisoni, Laura; Hodgin, Jeffrey B


    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.

  11. 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


    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)

  12. Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis. (United States)

    Ross, Joseph S


    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.

  13. Importance of Pharmaceutical Training and Clinical Research at Medical Facilities. (United States)

    Myotoku, Michiaki


    To respond to advancements in medical techniques, and to address the separation of medical and dispensary practices, clinical professors are required to educate human resource staff to become highly-skilled pharmacists. For this purpose, it is extremely important for these professors to learn about cutting-edge practical skills and knowledge, as well as to advance their expertise. In addition, they need to conduct clinical research in cooperation with relevant facilities. As our university does not have its own hospital or pharmacy, it is important to provide training for clinical professors in clinical facilities. Such training mainly involves medical teams' in-hospital rounds and participation in conferences (nutrition support team; NST), operation of the pharmacy department, and intervention targeting improvement in the department's duties. We have conducted collaborative studies, provided research instructions, implemented studies aimed at improving the department's work (pharmacists appointed on wards at all times to ensure medical safety) as well as studies regarding team medical care (nutritional evaluation during outpatient chemotherapy), and resolved issues regarding this work (drug solution mixability in a hand-held constant infusion pump, and a safe pump-filling methods). Thus, it has become possible to keep track of the current state of a pharmacists' work within team medical care, to access information about novel drugs, to view clinical and prescription-claim data, to cooperate with other professionals (e.g., doctors and nurses), to promote pharmacists' self-awareness of their roles in cooperative medical practice, and to effectively maintain the hospital's clinical settings.

  14. Clinical scientific research with ionizing radiations in Italy. Jurisprudential aspects

    International Nuclear Information System (INIS)

    Valle, G.; Frusciante, V.; Petrucelli, L.; Podagrosi, V.; Giustini, A.


    The paper reviews the laws that regulate the clinical scientific research with ionizing radiations in Italy and the effects of ICRP 62, introduced in Italy by the Minister's Decree 21/11/1997, renders invalid all previous rules and regulations which contrast with them [it

  15. Surrogate end points in clinical research: hazardous to your health. (United States)

    Grimes, David A; Schulz, Kenneth F


    Surrogate end points in clinical research pose real danger. A surrogate end point is an outcome measure, commonly a laboratory test, that substitutes for a clinical event of true importance. Resistance to activated protein C, for example, has been used as a surrogate for venous thrombosis in women using oral contraceptives. Other examples of inappropriate surrogate end points in contraception include the postcoital test instead of pregnancy to evaluate new spermicides, breakage and slippage instead of pregnancy to evaluate condoms, and bone mineral density instead of fracture to assess the safety of depo-medroxyprogesterone acetate. None of these markers captures the effect of the treatment on the true outcome. A valid surrogate end point must both correlate with and accurately predict the outcome of interest. Although many surrogate markers correlate with an outcome, few have been shown to capture the effect of a treatment (for example, oral contraceptives) on the outcome (venous thrombosis). As a result, thousands of useless and misleading reports on surrogate end points litter the medical literature. New drugs have been shown to benefit a surrogate marker, but, paradoxically, triple the risk of death. Thousands of patients have died needlessly because of reliance on invalid surrogate markers. Researchers should avoid surrogate end points unless they have been validated; that requires at least one well done trial using both the surrogate and true outcome. The clinical maxim that "a difference to be a difference must make a difference" applies to research as well. Clinical research should focus on outcomes that matter.

  16. Fair Inclusion of Pregnant Women in Clinical Research

    NARCIS (Netherlands)

    van der Zande, I.S.E.


    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

  17. Original Research Clinical characteristics and outcomes of patients ...

    African Journals Online (AJOL)

    Epidemiological data on stroke in Zimbabwe are scarce and few clinical studies have been performed to date. ... Original Research ... of the patients were in the economically active group with ..... in Sub-Saharan Africa: what we know now; International Journal of ... University of Medicine and Dentistry OF New Jersey.

  18. Core outcome sets for research and clinical practice

    NARCIS (Netherlands)

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


    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

  19. A pragmatic analysis of vulnerability in clinical research. (United States)

    Wendler, David


    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.

  20. Data management in clinical research: Synthesizing stakeholder perspectives. (United States)

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


    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

  1. Clinical gait analysis : A review of research at the Interdepartmental Research group of Kinesiology in Leiden

    NARCIS (Netherlands)

    Daanen, H. A M


    In this article the methodology used in the Interdepartmental Research Group of Kinesiology to quantify (clinical) human gait is elaborated upon. Four methods are described: analysis of temporal parameters, goniometry, accelerometry and electromyography. A correct representation of electromyographic

  2. The UK clinical research network - has it been a success for dermatology clinical trials?

    Directory of Open Access Journals (Sweden)

    Charlesworth Lisa


    Full Text Available Abstract Background Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS. Methods This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. Results In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Conclusions Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales, and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

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

    Directory of Open Access Journals (Sweden)

    Abigail H. Natenshon


    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.

  4. Encouraging primary care research: evaluation of a one-year, doctoral clinical epidemiology research course. (United States)

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


    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

  5. Regulation of clinical research and bioethics in Portugal. (United States)

    Carvalho, Fatima Lampreia


    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.

  6. Regulatory Framework for Conducting Clinical Research in Canada. (United States)

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


    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.

  7. Bibliography of clinical research in malaysia: methods and brief results. (United States)

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


    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).

  8. The Ethics of Clinical Care and the Ethics of Clinical Research: Yin and Yang. (United States)

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


    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:

  9. Understanding clinical reasoning in osteopathy: a qualitative research approach. (United States)

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


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

  10. Use of altered informed consent in pragmatic clinical research. (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


    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.

  11. Teaching clinical reasoning by making thinking visible: an action research project with allied health clinical educators. (United States)

    Delany, Clare; Golding, Clinton


    Clinical reasoning is fundamental to all forms of professional health practice, however it is also difficult to teach and learn because it is complex, tacit, and effectively invisible for students. In this paper we present an approach for teaching clinical reasoning based on making expert thinking visible and accessible to students. Twenty-one experienced allied health clinical educators from three tertiary Australian hospitals attended up to seven action research discussion sessions, where they developed a tentative heuristic of their own clinical reasoning, trialled it with students, evaluated if it helped their students to reason clinically, and then refined it so the heuristic was targeted to developing each student's reasoning skills. Data included participants' written descriptions of the thinking routines they developed and trialed with their students and the transcribed action research discussion sessions. Content analysis was used to summarise this data and categorise themes about teaching and learning clinical reasoning. Two overriding themes emerged from participants' reports about using the 'making thinking visible approach'. The first was a specific focus by participating educators on students' understanding of the reasoning process and the second was heightened awareness of personal teaching styles and approaches to teaching clinical reasoning. We suggest that the making thinking visible approach has potential to assist educators to become more reflective about their clinical reasoning teaching and acts as a scaffold to assist them to articulate their own expert reasoning and for students to access and use.

  12. Leaders, leadership and future primary care clinical research

    Directory of Open Access Journals (Sweden)

    Qureshi Nadeem


    Full Text Available Abstract Background A strong and self confident primary care workforce can deliver the highest quality care and outcomes equitably and cost effectively. To meet the increasing demands being made of it, primary care needs its own thriving research culture and knowledge base. Methods Review of recent developments supporting primary care clinical research. Results Primary care research has benefited from a small group of passionate leaders and significant investment in recent decades in some countries. Emerging from this has been innovation in research design and focus, although less is known of the effect on research output. Conclusion Primary care research is now well placed to lead a broad re-vitalisation of academic medicine, answering questions of relevance to practitioners, patients, communities and Government. Key areas for future primary care research leaders to focus on include exposing undergraduates early to primary care research, integrating this early exposure with doctoral and postdoctoral research career support, further expanding cross disciplinary approaches, and developing useful measures of output for future primary care research investment.

  13. Speeding by young novice drivers: What can personal characteristics and psychosocial theory add to our understanding? (United States)

    Scott-Parker, Bridie; Hyde, Melissa K; Watson, Barry; King, Mark J


    Young novice drivers continue to be overrepresented in fatalities and injuries arising from crashes even with the introduction of countermeasures such as graduated driver licensing (GDL). Enhancing countermeasures requires a better understanding of the variables influencing risky driving. One of the most common risky behaviours performed by drivers of all ages is speeding, which is particularly risky for young novice drivers who, due to their driving inexperience, have difficulty in identifying and responding appropriately to road hazards. Psychosocial theory can improve our understanding of contributors to speeding, thereby informing countermeasure development and evaluation. This paper reports an application of Akers' social learning theory (SLT), augmented by Gerrard and Gibbons' prototype/willingness model (PWM), in addition to personal characteristics of age, gender, car ownership, and psychological traits/states of anxiety, depression, sensation seeking propensity and reward sensitivity, to examine the influences on self-reported speeding of young novice drivers with a Provisional (intermediate) licence in Queensland, Australia. Young drivers (n=378) recruited in 2010 for longitudinal research completed two surveys containing the Behaviour of Young Novice Drivers Scale, and reported their attitudes and behaviours as pre-Licence/Learner (Survey 1) and Provisional (Survey 2) drivers and their sociodemographic characteristics. An Akers' measurement model was created. Hierarchical multiple regressions revealed that (1) personal characteristics (PC) explained 20.3%; (2) the combination of PC and SLT explained 41.1%; (3) the combination of PC, SLT and PWM explained 53.7% of variance in self-reported speeding. Whilst there appeared to be considerable shared variance, the significant predictors in the final model included gender, car ownership, reward sensitivity, depression, personal attitudes, and Learner speeding. These results highlight the capacity for

  14. Clinical research in small genomically stratified patient populations. (United States)

    Martin-Liberal, J; Rodon, J


    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.

  15. Clinical research of traditional Chinese medicine in big data era. (United States)

    Zhang, Junhua; Zhang, Boli


    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.

  16. Are research papers reporting results from nutrigenetics clinical research a potential source of biohype? (United States)

    Stenne, R; Hurlimann, T; Godard, Béatrice


    Nutrigenetics is a promising field, but the achievability of expected benefits is challenged by the methodological limitations that are associated with clinical research in that field. The mere existence of these limitations suggests that promises about potential outcomes may be premature. Thus, benefits claimed in scientific journal articles in which these limitations are not acknowledged might stimulate biohype. This article aims to examine whether nutrigenetics clinical research articles are a potential source of biohype. Of the 173 articles identified, 16 contained claims in which clinical applications were extrapolated from study results. The methodological limitations being incompletely acknowledged, these articles could potentially be a source of biohype.

  17. Investigating Peer Review as a Systemic Pedagogy for Developing the Design Knowledge, Skills, and Dispositions of Novice Instructional Design Students (United States)

    Brill, Jennifer M.


    This research investigated peer review as a contemporary instructional pedagogy for fostering the design knowledge, skills, and dispositions of novice Instructional Design and Technology (IDT) professionals. Participants were graduate students enrolled in an introductory instructional design (ID) course. Survey, artifact, and observation data were…

  18. A Phenomenological Study Investigating Transformative Learning Strategies Implemented by 10 Title I Elementary Principals That Influence Novice Teacher Retention (United States)

    Fountain, Tara


    The purpose of this qualitative phenomenological study was to investigate transformative learning strategies implemented by 10 Title I elementary principals that influence novice teacher retention. Data were gathered by individual interviews. Data were analyzed using Creswell's (2013) description of qualitative research as a collection of data…

  19. Learner-Generated Noticing Behavior by Novice Learners: Tracing the Effects of Learners' L1 on Their Emerging L2 (United States)

    Park, Eun Sung


    This study examines novice learners' self-generated input noticing approaches and strategies. It is motivated by previous research on input enhancement which yielded insights that learners are naturally prone to notice certain aspects of L2 input on their own without any external means to channel their attention. Two L1 groups (Japanese and…

  20. Novice designers’ use of prototypes in engineering design (United States)

    Deininger, Michael; Daly, Shanna R.; Sienko, Kathleen H.; Lee, Jennifer C.


    Prototypes are essential tools in product design processes, but are often underutilized by novice designers. To help novice designers use prototypes more effectively, we must first determine how they currently use prototypes. In this paper, we describe how novice designers conceptualized prototypes and reported using them throughout a design project, and compare reported prototyping use to prototyping best practices. We found that some of the reported prototyping practices by novice designers, such as using inexpensive prototypes early and using prototypes to define user requirements, occurred infrequently and lacked intentionality. Participants’ initial descriptions of prototypes were less sophisticated than how they later described using them and only upon prompted reflection did participants recognize more specific benefits of using prototypes. PMID:29398740

  1. Impact of radiation research on clinical trials in radiation oncology

    International Nuclear Information System (INIS)

    Rubin, P.; Van Ess, J.D.


    The authors present an outline review of the history of the formation of the cooperative group called International Clinical Trials in Radiation Oncology (ICTRO), and the following areas are briefly discussed together with some projections for the direction of clinical trials in radiation oncology into the 1990s:- radiosensitizers, radioprotectors, and their combination, drug-radiation interactions, dose/time/fractionation, hyperthermia, biological response modifiers and radiolabelled antibodies, high LET, particularly neutron therapy, large field irradiation and interoperative irradiation, research studies on specific sites. (U.K.)

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


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


    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...

  3. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations. (United States)

    Pierre, Christine


    Physicians who participate in clinical research studies gain benefits for themselves, their practice, and their patients. Historically, private practice physicians have chosen to defer to their counterparts in academic medicine when it comes to contributing to scientific advancement through clinical studies. A growing number of private practice physicians are now taking a serious second look and deciding that there are unique benefits for both the practice and the patient. Physicians who decide to participate in clinical research should give serious consideration to the time and resources that are required to meet both federal regulations and industry standards. In addition, ethical and scientific principles for assuring the protection of human research subjects must be a paramount commitment.

  4. Conducting Clinically Based Intimate Partner Violence Research: Safety Protocol Recommendations. (United States)

    Anderson, Jocelyn C; Glass, Nancy E; Campbell, Jacquelyn C

    Maintaining safety is of utmost importance during research involving participants who have experienced intimate partner violence (IPV). Limited guidance on safety protocols to protect participants is available, particularly information related to technology-based approaches to informed consent, data collection, and contacting participants during the course of a study. The purpose of the article is to provide details on the safety protocol developed and utilized with women receiving care at an urban HIV clinic and who were taking part in an observational study of IPV, mental health symptoms, and substance abuse and their relationship to HIV treatment adherence. The protocol presents the technological strategies to promote safety and allow autonomy in participant decision-making throughout the research process, including Voice over Internet Protocol telephone numbers, and tablet-based eligibility screening and data collection. Protocols for management of participants at risk for suicide and/or intimate partner homicide that included automated high-risk messaging to participants and research staff and facilitated disclosure of risk to clinical staff based on participant preferences are discussed. Use of technology and partnership with clinic staff helped to provide an environment where research regarding IPV could be conducted without undue burden or risk to participants. Utilizing tablet-based survey administration provided multiple practical and safety benefits for participants. Most women who screened into high-risk categories for suicide or intimate partner homicide did not choose to have their results shared with their healthcare providers, indicating the importance of allowing participants control over information sharing whenever possible.

  5. Novice to expert practice via postprofessional athletic training education: a grounded theory. (United States)

    Neibert, Peter J


    To discover the theoretic constructs that confirm, disconfirm, or extend the principles and their applications appropriate for National Athletic Trainers' Association (NATA)-accredited postprofessional athletic training education programs. Interviews at the 2003 NATA Annual Meeting & Clinical Symposia. Qualitative study using grounded theory procedures. Thirteen interviews were conducted with postprofessional graduates. Participants were purposefully selected based on theoretic sampling and availability. The transcribed interviews were analyzed using open coding, axial coding, and selective coding procedures. Member checks, reflective journaling, and triangulation were used to ensure trustworthiness. The participants' comments confirmed and extended the current principles of postprofessional athletic training education programs and offered additional suggestions for more effective practical applications. The emergence of this central category of novice to expert practice is a paramount finding. The tightly woven fabric of the 10 processes, when interlaced with one another, provides a strong tapestry supporting novice to expert practice via postprofessional athletic training education. The emergence of this theoretic position pushes postprofessional graduate athletic training education forward to the future for further investigation into the theoretic constructs of novice to expert practice.

  6. Predictors of running-related injuries in novice runners enrolled in a systematic training program: a prospective cohort study. (United States)

    Buist, Ida; Bredeweg, Steef W; Lemmink, Koen A P M; van Mechelen, Willem; Diercks, Ron L


    The popularity of running is still growing. As participation increases, running-related injuries also increase. Until now, little is known about the predictors for injuries in novice runners. Predictors for running-related injuries (RRIs) will differ between male and female novice runners. Cohort study; Level of evidence, 2. Participants were 532 novice runners (226 men, 306 women) preparing for a recreational 4-mile (6.7-km) running event. After completing a baseline questionnaire and undergoing an orthopaedic examination, they were followed during the training period of 13 weeks. An RRI was defined as any self-reported running-related musculoskeletal pain of the lower extremity or back causing a restriction of running for at least 1 week. Twenty-one percent of the novice runners had at least one RRI during follow-up. The multivariate adjusted Cox regression model for male participants showed that body mass index (BMI) (hazard ratio [HR], 1.15; 95% confidence interval [CI], 1.05-1.26), previous injury in the past year (HR, 2.7; 95% CI, 1.36-5.55), and previous participation in sports without axial load (HR, 2.05; 95% CI, 1.03-4.11) were associated with RRI. In female participants, only navicular drop (HR, 0.85; 95% CI, 0.75-0.97) remained a significant predictor for RRI in the multivariate Cox regression modeling. Type A behavior and range of motion (ROM) of the hip and ankle did not affect risk. Male and female novice runners have different risk profiles. Higher BMI, previous injury, and previous sports participation without axial loading are important predictors for RRI in male participants. Further research is needed to detect more predictors for female novice runners.

  7. Systematic collection of patient reported outcome research data: A checklist for clinical research professionals. (United States)

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


    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.

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

  9. Prognosis research strategy (PROGRESS) 1: A framework for researching clinical outcomes

    NARCIS (Netherlands)

    H. Hemingway; P. Croft (Peter); P. Perel (Pablo); J. Hayden (Jill); D. Abrams; A. Timmis (Adam); A. Briggs (Andrew); R. Udumyan (Ruzan); K.G.M. Moons (Karel); E.W. Steyerberg (Ewout); I. Roberts (Ian); S. Schroter (Sara); D.G. Altman (Douglas); R.D. Riley (Richard); N. Brunner; A. Hingorani (Aroon); P.A. Kyzas (Panayiotis); N. Malats (Núria); G. Peat; W. Sauerbrei (Willi); D.A.W.M. van der Windt (Daniëlle)


    textabstractUnderstanding and improving the prognosis of a disease or health condition is a priority in clinical research and practice. In this article, the authors introduce a framework of four interrelated themes in prognosis research, describe the importance of the first of these themes

  10. Lived Experience: Perceptions of Competency of Novice Teachers

    Directory of Open Access Journals (Sweden)

    Pauline Swee Choo Goh


    Full Text Available This study bridges the gap of an outsider-insider perspective of competency and captures the essence of what constitutes competency among 18 novice teachers in their own actions performed in real classrooms. In this study, relevant aspects of the novice teachers’ ‘lived-experience’ in their schools make up their conceptions of competency. Novice teachers’ talk about achieving their aims of competency in strategically different ways and in each of these ways, the novice teachers’ strategies are critical to their understanding of the novice teacher-student roles. Five identified conceptions are: controls in the classroom and behaviour of students, methodical preparation, uses of sound in pedagogical knowledge and skills, understanding and empowering their students to take charge of their own learning, and an awareness of themselves as teachers. The conceptions of competency are represented diagrammatically and are discussed with respect to levels of complexity. Variation exists in the way novice teachers conceive of their competency. Teacher educators should be cognizant of the diversity in practices of teachers and not limit that to say that there is just one acceptable conception of competency.

  11. [Thinking on designation of sham acupuncture in clinical research]. (United States)

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


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

  12. Beyond "utilitarianism": maximizing the clinical impact of moral judgment research. (United States)

    Rosas, Alejandro; Koenigs, Michael


    The use of hypothetical moral dilemmas--which pit utilitarian considerations of welfare maximization against emotionally aversive "personal" harms--has become a widespread approach for studying the neuropsychological correlates of moral judgment in healthy subjects, as well as in clinical populations with social, cognitive, and affective deficits. In this article, we propose that a refinement of the standard stimulus set could provide an opportunity to more precisely identify the psychological factors underlying performance on this task, and thereby enhance the utility of this paradigm for clinical research. To test this proposal, we performed a re-analysis of previously published moral judgment data from two clinical populations: neurological patients with prefrontal brain damage and psychopathic criminals. The results provide intriguing preliminary support for further development of this assessment paradigm.

  13. Retention of minority participants in clinical research studies. (United States)

    Keller, Colleen S; Gonzales, Adelita; Fleuriet, K Jill


    Recruitment of minority participants for clinical research studies has been the topic of several analytical works. Yet retention of participants, most notably minority and underserved populations, is less reported and understood, even though these populations have elevated health risks. This article describes two related, intervention-based formative research projects in which researchers used treatment theory to address issues of recruitment and retention of minority women participants in an exercise program to reduce obesity. Treatment theory incorporates a model of health promotion that allows investigators to identify and control sources of extraneous variables. The authors' research demonstrates that treatment theory can improve retention of minority women participants by considering critical inputs, mediating processes, and substantive participant characteristics in intervention design.

  14. Ethics and epistemology of accurate prediction in clinical research. (United States)

    Hey, Spencer Phillips


    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

  15. Single cell analysis contemporary research and clinical applications

    CERN Document Server

    Cossarizza, Andrea


    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.

  16. The DSM and Professional Practice: Research, Clinical, and Institutional Perspectives. (United States)

    Halpin, Michael


    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. [Current situation of clinical research on impacted premolars]. (United States)

    Liu, Ran-Ran; Tian, Jun


    Teeth impaction is a common developmental malformation in oral diseases. Impacted teeth are usually the canines, third molar, central incisors, premolars, and second molars. The prevalence of impaction of maxillary canines and mandibular wisdom teeth is higher than that of other teeth. Most recent studies have focused on the canines and third molars, but research on impacted premolars is limited. In clinical practice, the majority of orthodontic patients require premolar extraction. Thus, impacted premolars play important roles in orthodontic design and prognosis. This article provides an overview of recent research on impacted premolars and summarizes epidemiological features, localizations, and treatments, with the aim of guiding practitioners on orthodontic design and therapy.

  18. Innovative designs for radiation oncology research in clinical trials

    International Nuclear Information System (INIS)

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


    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

  19. Integrated and Gender-Affirming Transgender Clinical Care and Research (United States)

    Radix, Asa; Deutsch, Madeline B.


    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

  20. The Design and Development of a Technology Based Orientation Manual for Clinical Research Coordinators (United States)

    Copp, Susan L.


    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…

  1. Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care

    Directory of Open Access Journals (Sweden)

    Paola Frati


    Full Text Available The latest research achievements in the field of stem cells led in 2016 to the publication of “Guidelines for Stem Cell Research and Clinical Translation” by the International Society for Stem Cell Research (ISSCR. Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient’s welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered.

  2. Citation analysis may severely underestimate the impact of clinical research as compared to basic research. (United States)

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


    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.

  3. Does early training improve driving skills of young novice French drivers? (United States)

    Freydier, Chloé; Berthelon, Catherine; Bastien-Toniazzo, Mireille


    The aim of this research was to study drivers' performances and divided attention depending on their initial training. The performances of young novice drivers who received early training, traditionally trained drivers and more experienced drivers were compared during a dual task consisting of a simulated car-following task and a number' parity judgment task. It was expected that, due to their limited driving experience, the young novice drivers would have more difficulty in adequately distributing their attention between the two tasks. Poorer performances by novice drivers than experienced drivers were therefore expected. The results indicate that traditionally trained drivers had more difficulties in speed regulation and maintaining their position in the lane than drivers with early training and experienced drivers. Performance impairment linked to driving inexperience was also found in the secondary task. The results were interpreted regarding the attentional resources involved in driving with a secondary task and supported the positive effects of French early training. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Novice nurse productivity following workplace bullying. (United States)

    Berry, Peggy A; Gillespie, Gordon L; Gates, Donna; Schafer, John


    To determine the prevalence and effects of workplace bullying (WPB) on the work productivity of novice nurses (NNs). Internet-based descriptive cross-sectional survey design. One hundred ninety seven NNs (91.4% female, 8.6% male) in practice less than 2 years completed the Healthcare Productivity Survey, Negative Acts Questionnaire, and a demographic survey. The majority (72.6%, n= 147) of NNs reported a WPB event within the previous month, with 57.9% (n= 114) the direct targets and another 14.7% (n= 29) witnesses of WPB behaviors. Using a weighted Negative Acts Questionnaire score, 21.3% (n= 43) of NNs were bullied daily over a 6-month period. When asked if bullied over the past 6 months, approximately 44.7% (n= 88) of NNs reported repeated, targeted WPB, with 55.3% (n= 109) reporting no WPB. WPB acts were primarily perpetrated by more experienced nursing colleagues (63%, n= 126). Further, work productivity regression modeling was significant and NN productivity was negatively impacted by workplace bullying (r=-.322, p= .045). WPB continues in the healthcare environment and negatively affects bullied NNs' productivity by affecting cognitive demands and ability to handle or manage their workload. Healthcare facilities should continue to measure WPB in the work environment after policy implementation as well as eliminate negative behaviors through root-cause analysis to correct environmental factors associated with WPB. © 2012 Sigma Theta Tau International.

  5. Stem cell therapy clinical research: A regulatory conundrum for academia. (United States)

    Nagpal, Anjali; Juttner, Chris; Hamilton-Bruce, Monica Anne; Rolan, Paul; Koblar, Simon A


    The encouraging pace of discovery and development in the field of regenerative medicine holds tremendous potential for bringing therapies to the clinic that may offer meaningful benefit to patients, particularly in diseases with no or suboptimal therapeutic options. Academic researchers will continue to play a critical role in developing concepts and therapies, thus determining whether regenerative medicine will be able to live up to this potential that clearly excites clinicians, researchers and patients alike. This review summarises recent developments in regulatory frameworks across different countries that aim to ensure adequate oversight of the development of regenerative medicine products, which are unique in structural and functional complexity when compared to traditional chemical drugs and fully characterised biological drugs. It discusses the implications of these developments for researchers aiming to make the challenging transition from laboratory to clinical development of these therapies and considers possible pragmatic solutions that could accelerate this process that is essential to maintain research credibility and ensure patient safety. Copyright © 2016 Elsevier B.V. All rights reserved.

  6. Smart Extraction and Analysis System for Clinical Research. (United States)

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


    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.

  7. Investigate-and-redesign tasks as a context for learning and doing science and technology: A study of naive, novice and expert high school and adult designers doing product comparisons and redesign tasks (United States)

    Crismond, David Paul

    This thesis studied high school students and adults with varying degrees of design experience doing two technology investigate-and-redesign (I&R) tasks. Each involved subjects investigating products, designing experiments to compare them fairly, and then redesigning the devices. A total of 25 pairs of subjects participated in this investigation and included naive and novice high school designers, as well as naive, novice, and expert adult designers. Subjects of similar age and design experience worked in same-gender teams and met for two 2-hour sessions. The essential research question of this thesis was: "What process skills and concepts do naive, novice and expert designers use and learn when investigating devices, designing experiments, and redesigning the devices?" Three methodologies were used to gather and analyze the data: clinical interviewing (Piaget, 1929/1960), protocol analysis (Ericsson & Simon, 1984) and interaction analysis (Jordan and Henderson, 1995). The thesis provides composite case-studies of 10 of the 50 test sessions, buttressed by descriptions of performance trends for all subjects. Given the small sample sizes involved, the findings are by necessity tentative and not supported by statistical analysis: (1) I&R activities are engaging, less time-intensive complements to design-and-build tasks, which involve simple mechanical devices and carry with them a host of potential "alternative understandings" in science and technology. Much gets learned during these tasks, more involving "device knowledge" and "device inquiry skills" than "big ideas" in science and technology. (2) Redesign tasks scaffold naive and novice designers to improved performance in the multidimensional and context-specific activity of design. The performances of naive and novice designers were more like that of expert designers when redesigning existing devices than when doing start-from-scratch designing. (3) Conceptual redesign involved more analysis- than synthesis

  8. [Mental issues of clinical research interviews in an intercultural context]. (United States)

    Kim, M-S; Derivois, D


    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

  9. Is audit research? The relationships between clinical audit and social-research. (United States)

    Hughes, Rhidian


    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.

  10. Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research. (United States)

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


    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.

  11. Key factors in children's competence to consent to clinical research. (United States)

    Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L


    Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (P > 0.05). Age is the factor that

  12. Clinical trial network for the promotion of clinical research for rare diseases in Japan: muscular dystrophy clinical trial network. (United States)

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


    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

  13. Emerging uses of patient generated health data in clinical research. (United States)

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


    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.

  14. Ethical considerations in clinical training, care and research in psychopharmacology. (United States)

    Strous, Rael D


    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.

  15. 78 FR 60885 - Proposed Collection; 60-Day Notice Request: Application Process for Clinical Research Training... (United States)


    ... Notice Request: Application Process for Clinical Research Training and Medical Education at the Clinical... Research Training and Medical Education, NIH Clinical Center, 10 Center Drive, MSC 1158, Bethesda, MD 20892... Process for Clinical Research Training and Medical Education at the Clinical Center and its Impact on...

  16. 78 FR 79703 - Submission for OMB Review; 30-Day Comment Request: Application Process for Clinical Research... (United States)


    ...; 30-Day Comment Request: Application Process for Clinical Research Training and Medical Education at..., MD, Deputy Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center... Clinical Research Training and Medical Education at the Clinical Center and its Impact on Course and...

  17. Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research. (United States)

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


    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.

  18. Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries. (United States)

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


    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.

  19. Evaluating the risks of clinical research: direct comparative analysis. (United States)

    Rid, Annette; Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S; Wendler, David


    Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed "risks of daily life" standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations. This study employed a conceptual and normative analysis, and use of an illustrative example. Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the "risks of daily life" standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents. Direct comparative analysis is a systematic method for applying the "risks of daily life" standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about research risks.

  20. A 50-year research journey. From laboratory to clinic. (United States)

    Ross, John


    Prior important research is not always cited, exemplified by Oswald Avery's pioneering discovery that DNA is the genetic transforming factor; it was not cited by Watson and Crick 10 years later. My first laboratory research (National Institutes of Health 1950s) resulted in the clinical development of transseptal left heart catheterization. Laboratory studies on cardiac muscle mechanics in normal and failing hearts led to the concept of afterload mismatch with limited preload reserve. At the University of California, San Diego in La Jolla (1968) laboratory experiments on coronary artery reperfusion after sustained coronary occlusion showed salvage of myocardial tissue, a potential treatment for acute myocardial infarction proven in clinical trials of thrombolysis 14 years later. Among 60 trainees who worked with me in La Jolla, one-third were Japanese and some of their important laboratory experiments are briefly recounted, beginning with Sasayama, Tomoike and Shirato in the 1970 s. Recently, we developed a method for cardiac gene transfer, and subsequently we showed that gene therapy for the defect in cardiomyopathic hamsters halted the progression of advanced disease. Cardiovascular research and medicine are producing continuing advances in technologies for gene transfer and embryonic stem cell transplantation, targeting of small molecules, and tissue and organ engineering.

  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.


    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. The importance of clinical case reports in research

    Directory of Open Access Journals (Sweden)

    Ricardo Pineda-Leguízamo


    Full Text Available Clinical case reports correspond to articles that have the lowest level of evidence within different research trials. However, not only are they common and significant in the medical field, but they have often been the basis the generation of research. The purpose of their publication can be scientific or educational. In general terms, the discovery of new diseases, the presentation of rare diseases, unusual forms of common diseases, the complications of a common treatment, or the effect (beneficial or adverse of a treatment, among other things, are narrated in these documents. Clinical case reports continue to be one of the most important sources of knowledge. The advent of a standardized guideline for the creation of this type of reports allows homogenizing the form and content of the cases intended to be described in the near future and, furthermore, will enable authors to have a reference when preparing this type of publications. Case reports are valuable resources of new and unusual information that can encourage and serve to conduct future research studies with a higher level of evidence.

  3. Integrative Mental Health (IMH): paradigm, research, and clinical practice. (United States)

    Lake, James; Helgason, Chanel; Sarris, Jerome


    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: 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.

  4. Changes in spirituality among ayahuasca ceremony novice participants. (United States)

    Trichter, Stephen; Klimo, Jon; Krippner, Stanley


    Ayahuasca, a hallucinogenic plant brew from the Amazon basin used as part of healing ceremonies by the local indigenous people of the region for centuries, is now being consumed by growing numbers of people throughout the world. Anecdotal evidence and previous research suggest that there are spiritual effects experienced among participants who take part in ayahuasca ceremonies. The current study examined whether novice participants' spirituality was affected through participation in an ayahuasca ceremony, and if so, how. A mixed-design method was used, comparing those participating in an ayahuasca ceremony to those who did not participate. This investigation used the Peak Experience Profile, the Spiritual Well-being Scale, and the Mysticism Scale as quantitative measures. Participant interviews and written accounts of ceremony experiences were analyzed. Results showed that neither the SWB score nor the M-Scale score increased significantly after participating in an ayahuasca ceremony. However, it was found that the higher the PEP score, the greater the positive change in SWB and M-Scale scores. Qualitative data revealed common spiritual themes in many of the participants' interviews and written accounts. Experiential differences were displayed within the ayahuasca ceremony group, warranting continued investigation into, and identification of, various confounding variables that prompt reported changes in spirituality within some participants while not in others.

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

    Directory of Open Access Journals (Sweden)

    Enderli TA


    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

  6. Henry Beecher's Contributions to the Ethics of Clinical Research. (United States)

    Veatch, Robert M


    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.

  7. Clinical research involving minors in international and serbian regulations. (United States)

    Planojević, Nina; Zivojinović, Dragica


    Participation in clinical trials can be useful for the health of a person, in who it is conducted, but it does not have to be - it can even be harmful. Therefore, primary motive to accept such risk is humanity and human wish to contribute to the progress of medicine; this is expressed by personal consent. The consent, however, can be an expression of personal humanity, and for this, it is not logical that someone can give consent on behalf of someone else, as it is done by a legally authorized representative on behalf of a minor. Therefore, authors raise 3 questions: What are the reasons to consider representative's consent acceptable? How should a model of regulations look like in order to provide the most complete possible protection to a minor? Is actual regulation of minors' position within international and Serbian law, analyzed here by authors for their specific solutions, acceptable? Representative's consent is acceptable only for therapeutic research, because these can bring benefits to everyone's health, including a minor in which those are conducted - this is an acceptable (secondary) motive of participation in the research. Expression of humanity on other's behalf, typical for non-therapeutic research, is not acceptable; this makes ban of minors' participation in non-therapeutic research more appropriate regulation model. International regulations are not in accordance to results presented in the paper for allowing participation of minors both in therapeutic and non-therapeutic research. Serbian regulation is closer to the most acceptable regulation model.

  8. Health claims on foods: challenge for clinical research companies

    Directory of Open Access Journals (Sweden)

    Essi Sarkkinen


    Full Text Available Background The Nutrition and Health Claim Regulation 1924/2006/EC, together with EFSA guidances on the scientific requirements for different type of health claims, is setting the basis for health claim substantiation in the EU. Aim The aim of this presentation is to bring up the key challenges that the food industry and clinical research organizations are facing when meeting these requirements. Results and discussion Key issues in clinical research planning to meet the requirements set for the health claim substantiation are: (1 Selection of right outcome markers since the selection of outcome marker defines actually the formulation of the health claim to be used on food or food ingredient. (2 Selection of right target population since that determines the target consumer group for the food with a health claim. (3 Selection of dose regime and food matrices used since these largely determine the conditions set for the use of the health claim. One of the major challenges in health claim substantiation is the deviant approach to risk factors or biomarkers. From the regulation point of view, a single risk factor approach is emphasized, but from the clinical and scientific point of view the pattern of different risk markers or biomarkers could, in some cases, be a more relevant choice to reflect the final health outcome. This is especially the case in the nutrition and health area because we are often dealing with weak but multiple health effects of certain food items or ingredients. Also the lack of validated well-established biomarkers potent to be affected by diet is a challenge in health claim substantiation.The selection of right target population is often a compromise between choosing a more potential target group to obtain efficacy (i.e. risk factors elevated vs. patient groups and choosing a rationale to generalize the results to wider population (target consumer group.The selection of optimal dosing regime and matrices for a clinical study is

  9. Interactive Voice/Web Response System in clinical research. (United States)

    Ruikar, Vrishabhsagar


    Emerging technologies in computer and telecommunication industry has eased the access to computer through telephone. An Interactive Voice/Web Response System (IxRS) is one of the user friendly systems for end users, with complex and tailored programs at its backend. The backend programs are specially tailored for easy understanding of users. Clinical research industry has experienced revolution in methodologies of data capture with time. Different systems have evolved toward emerging modern technologies and tools in couple of decades from past, for example, Electronic Data Capture, IxRS, electronic patient reported outcomes, etc.

  10. Establishment of a research pharmacy to support Ebola clinical research in Liberia. (United States)

    Pierson, Jerome F; Kirchoff, Matthew Carl; Tyee, Rev Tijli; Montello, Michael J; Rhie, Julie K

    This article describes the establishment of a research pharmacy to support the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) vaccine study for Ebola virus disease. This article describes the establishment of the pharmacy element to support the overall research program during an Ebola outbreak in Monrovia, Liberia, in 2014 and 2015. The need for the rapid establishment of infrastructure to support the Liberia-United States joint clinical research partnership in response to the emerging Ebola virus disease provided the opportunity for collaboration among Liberian and U.S. pharmacists. Resource austere and research naïve. Research pharmacy prepared and randomized 1500 vaccinations in support of PREVAIL. Experiences of the Liberian and U.S. pharmacists involved in the program are described. The partnership was successful in the conduct of the study. More importantly, the capacity for Liberian pharmacists to support clinical research was established. In addition, the U.S. team learned several important lessons that will help prepare them for responding to research needs in future infectious disease outbreaks. Published by Elsevier Inc.

  11. Magnetic resonance spectroscopy in pediatric neuroradiology: clinical and research applications

    International Nuclear Information System (INIS)

    Panigrahy, Ashok; Nelson, Marvin D.; Blueml, Stefan


    Magnetic resonance spectroscopy (MRS) offers a unique, noninvasive approach to assess pediatric neurological abnormalities at microscopic levels by quantifying cellular metabolites. The most widely available MRS method, proton ( 1 H; hydrogen) spectroscopy, is FDA approved for general use and can be ordered by clinicians for pediatric neuroimaging studies if indicated. There are a multitude of both acquisition and post-processing methods that can be used in the implementation of MR spectroscopy. MRS in pediatric neuroimaging is challenging to interpret because of dramatic normal developmental changes that occur in metabolites, particularly in the first year of life. Still, MRS has been proven to provide additional clinically relevant information for several pediatric neurological disease processes such as brain tumors, infectious processes, white matter disorders, and neonatal injury. MRS can also be used as a powerful quantitative research tool. In this article, specific research applications using MRS will be demonstrated in relation to neonatal brain injury and pediatric brain tumor imaging. (orig.)

  12. Inexperienced but Effectual: the Importance of Conceptualizing Context in Expert Decision-Logic by Novices

    DEFF Research Database (Denmark)

    Günzel-Jensen, Franziska; Robinson, Sarah; Neergaard, Helle

    of effectual decision making logics and why these differ across student groups. Prior research: So far effectuation theory has been validated for expert entrepreneurs. Recent research indicates that even novices may make decisions based on effectual decision logics. Here the questions about what might mitigate...... period, where motivation and expectations are high and context impacts on the student’s ability to begin the process; ii) a phase of identity construction in teams, where relational aspects are integral to supporting the continuation of the process; and iii) a mastery phase where the five principles...

  13. Can emergency medicine research benefit from adaptive design clinical trials? (United States)

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


    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

  14. Patient registries: useful tools for clinical research in myasthenia gravis. (United States)

    Baggi, Fulvio; Mantegazza, Renato; Antozzi, Carlo; Sanders, Donald


    Clinical registries may facilitate research on myasthenia gravis (MG) in several ways: as a source of demographic, clinical, biological, and immunological data on large numbers of patients with this rare disease; as a source of referrals for clinical trials; and by allowing rapid identification of MG patients with specific features. Physician-derived registries have the added advantage of incorporating diagnostic and treatment data that may allow comparison of outcomes from different therapeutic approaches, which can be supplemented with patient self-reported data. We report the demographic analysis of MG patients in two large physician-derived registries, the Duke MG Patient Registry, at the Duke University Medical Center, and the INNCB MG Registry, at the Istituto Neurologico Carlo Besta, as a preliminary study to assess the consistency of the two data sets. These registries share a common structure, with an inner core of common data elements (CDE) that facilitate data analysis. The CDEs are concordant with the MG-specific CDEs developed under the National Institute of Neurological Disorders and Stroke Common Data Elements Project. © 2012 New York Academy of Sciences.

  15. [Research reveals a market for a veterinary behaviour clinic]. (United States)

    Jonckheer-Sheehy, Valerie; Endenburg, Nienke


    An enquiry into the requirement of a university veterinary behaviour clinic in The Netherlands revealed that there is a clear call for such a service. The specific demands and wishes of first line practicing veterinarians and companion animal owners were investigated. The research revealed that veterinarians are regular confronted with behaviour problems in companion animals and that they are willing to refer these cases to the University. They also expressed their need for access to continuing professional development opportunities in the field of veterinary behavioural medicine (which is something that most veterinary behaviour clinics associated with veterinary faculties provide). The demand from companion animal owners was also examined. It can be concluded that a large number of them had animals with behaviour problems and that they were willing to seek veterinary advice on these matters. In response to the above mentioned demands the University of Utrecht will open a veterinary behaviour clinic, providing high quality service for animals, their owners and the referring veterinarians. This service will be based on sound scientific practice and delivered by both veterinarians specialised in this field and recognised animal behaviour therapists.

  16. Recent theoretical, neural, and clinical advances in sustained attention research. (United States)

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


    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. Recent theoretical, neural, and clinical advances in sustained attention research (United States)

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


    Models of attention often distinguish between attention subtypes, with classic models separating orienting, switching, and sustaining functions. Compared to other forms of attention, the neurophysiological basis of sustaining attention has received far less attention yet it is known that momentary failures of sustained attention can have far ranging negative impacts 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 lifespan 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 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 of 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. PMID:28260249

  18. Basics of case report form designing in clinical research

    Directory of Open Access Journals (Sweden)

    Shantala Bellary


    Full Text Available 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.

  19. Basics of case report form designing in clinical research. (United States)

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


    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.

  20. Recruiting US Chinese Elders Into Clinical Research for Dementia. (United States)

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


    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.

  1. A critique of statistical hypothesis testing in clinical research

    Directory of Open Access Journals (Sweden)

    Somik Raha


    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.

  2. Financial disclosure and clinical research: what is important to participants? (United States)

    Hutchinson, Anastasia; Rubinfeld, Abe R


    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.

  3. Novice Nurses’ Perception of Working Night Shifts: A Qualitative Study

    Directory of Open Access Journals (Sweden)

    Mohsen Faseleh Jahromi


    Full Text Available Introduction: Nursing is always accompanied by shift working and nurses in Iran have to work night shifts in some stages of their professional life. Therefore, the present study aimed to describe the novice nurses’ perception of working night shifts. Methods: The present qualitative study was conducted on 20 novice nurses working in two university hospitals of Jahrom, Iran. The study data were collected through focus group interviews. All the interviews were recorded, transcribed, and analyzed using constant comparative analysis and qualitative content analysis. Results: The study findings revealed five major themes of value system, physical and psychological problems, social relationships, organizational problems, and appropriate opportunity. Conclusion: The study presented a deep understanding of the novice nurses’ perception of working night shifts, which can be used by the managers as a basis for organizing health and treatment systems.

  4. Comparing Expert and Novice Driving Behavior in a Driving Simulator

    Directory of Open Access Journals (Sweden)

    Hiran B. Ekanayake


    Full Text Available This paper presents a study focused on comparing driving behavior of expert and novice drivers in a mid-range driving simulator with the intention of evaluating the validity of driving simulators for driver training. For the investigation, measurements of performance, psychophysiological measurements, and self-reported user experience under different conditions of driving tracks and driving sessions were analyzed. We calculated correlations between quantitative and qualitative measures to enhance the reliability of the findings. The experiment was conducted involving 14 experienced drivers and 17 novice drivers. The results indicate that driving behaviors of expert and novice drivers differ from each other in several ways but it heavily depends on the characteristics of the task. Moreover, our belief is that the analytical framework proposed in this paper can be used as a tool for selecting appropriate driving tasks as well as for evaluating driving performance in driving simulators.

  5. Are cellular phone blocking applications effective for novice teen drivers? (United States)

    Creaser, Janet I; Edwards, Christopher J; Morris, Nichole L; Donath, Max


    Distracted driving is a significant concern for novice teen drivers. Although cellular phone bans are applied in many jurisdictions to restrict cellular phone use, teen drivers often report making calls and texts while driving. The Minnesota Teen Driver Study incorporated cellular phone blocking functions via a software application for 182 novice teen drivers in two treatment conditions. The first condition included 92 teens who ran a driver support application on a smartphone that also blocked phone usage. The second condition included 90 teens who ran the same application with phone blocking but which also reported back to parents about monitored risky behaviors (e.g., speeding). A third control group consisting of 92 novice teen drivers had the application and phone-based software installed on the phones to record cellular phone (but not block it) use while driving. The two treatment groups made significantly fewer calls and texts per mile driven compared to the control group. The control group data also demonstrated a higher propensity to text while driving rather than making calls. Software that blocks cellular phone use (except 911) while driving can be effective at mitigating calling and texting for novice teen drivers. However, subjective data indicates that some teens were motivated to find ways around the software, as well as to use another teen's phone while driving when they were unable to use theirs. Cellular phone bans for calling and texting are the first step to changing behaviors associated with texting and driving, particularly among novice teen drivers. Blocking software has the additional potential to reduce impulsive calling and texting while driving among novice teen drivers who might logically know the risks, but for whom it is difficult to ignore calling or texting while driving. Copyright © 2015 Elsevier Ltd and National Safety Council. All rights reserved.

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

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


    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.

  7. Identifying research priorities for effective retention strategies in clinical trials. (United States)

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


    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

  8. 77 FR 41431 - Proposed Collection; Comment Request: Impact of Clinical Research Training and Medical Education... (United States)


    ... Request: Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research SUMMARY: In compliance with the requirement of Section 3506(c)(2... approval. Proposed Collection Title: The Impact of Clinical Research Training and Medical Education at the...

  9. Critical Thinking and Clinical Judgment in Novice Registered Nurses (United States)

    Tyne, Sheila L.


    The health care field has become increasingly more complex, requiring new nurses to be prepared upon graduation to respond to a variety of complex situations. Unfortunately, many graduates from associate degree nursing (ADN) programs are not able to think critically upon entering the work force. This presents a major problem for the nurse and for…

  10. Protecting clinical data in PACS, teleradiology systems, and research environments (United States)

    Meissner, Marion C.; Collmann, Jeff R.; Tohme, Walid G.; Mun, Seong K.


    As clinical data is more widely stored in electronic patient record management systems and transmitted over the Internet and telephone lines, it becomes more accessible and therefore more useful, but also more vulnerable. Computer systems such as PACS, telemedicine applications, and medical research networks must protect against accidental or deliberate modification, disclosure, and violation of patient confidentiality in order to be viable. Conventional wisdom in the medical field and among lawmakers legislating the use of electronic medical records suggests that, although it may improve access to information, an electronic medical record cannot be as secure as a traditional paper record. This is not the case. Information security is a well-developed field in the computer and communications industry. If medical information systems, such as PACS, telemedicine applications, and research networks, properly apply information security techniques, they can ensure the accuracy and confidentiality of their patient information and even improve the security of their data over a traditional paper record. This paper will elaborate on some of these techniques and discuss how they can be applied to medical information systems. The following systems will be used as examples for the analysis: a research laboratory at Georgetown University Medical Center, the Deployable Radiology system installed to support the US Army's peace- keeping operation in Bosnia, a kidney dialysis telemedicine system in Washington, D.C., and various experiences with implementing and integrating PACS.


    Directory of Open Access Journals (Sweden)

    Mark Lyons


    Full Text Available Despite the acknowledged importance of fatigue on performance in sport, ecologically sound studies investigating fatigue and its effects on sport-specific skills are surprisingly rare. The aim of this study was to investigate the effect of moderate and high intensity total body fatigue on passing accuracy in expert and novice basketball players. Ten novice basketball players (age: 23.30 ± 1.05 yrs and ten expert basketball players (age: 22.50 ± 0.41 yrs volunteered to participate in the study. Both groups performed the modified AAHPERD Basketball Passing Test under three different testing conditions: rest, moderate intensity and high intensity total body fatigue. Fatigue intensity was established using a percentage of the maximal number of squat thrusts performed by the participant in one minute. ANOVA with repeated measures revealed a significant (F 2,36 = 5.252, p = 0.01 level of fatigue by level of skill interaction. On examination of the mean scores it is clear that following high intensity total body fatigue there is a significant detriment in the passing performance of both novice and expert basketball players when compared to their resting scores. Fundamentally however, the detrimental impact of fatigue on passing performance is not as steep in the expert players compared to the novice players. The results suggest that expert or skilled players are better able to cope with both moderate and high intensity fatigue conditions and maintain a higher level of performance when compared to novice players. The findings of this research therefore, suggest the need for trainers and conditioning coaches in basketball to include moderate, but particularly high intensity exercise into their skills sessions. This specific training may enable players at all levels of the game to better cope with the demands of the game on court and maintain a higher standard of play

  12. The First Five Years: Novice Teacher Beliefs, Experiences, and Commitment to the Profession (United States)

    Michel, Heather Ann


    Novice teacher attrition is a valid concern for public education. Some studies have found that 40-50% of novice teachers will leave the profession before they reach their fifth year of teaching. Previous literature states that novice teachers leave because of job dissatisfaction, school conditions and feeling ineffective with their students. This…

  13. A Content Analysis of Images of Novice Teacher Induction: First-Semester Themes (United States)

    Curry, Jennifer R.; Webb, Angela W.; Latham, Samantha J.


    The powerful nature of novice teachers' experiences in their first years of teaching has been well documented. However, the variance in novices' initial immersion in the school environment is largely dependent on perceived personal and professional support as well as the environmental inducements that lend to novice teachers' success in the…

  14. Challenges and Induction Needs of Novice English as a Foreign Language Teachers in Saudi Arabia (United States)

    Alhamad, Rufaida


    The first year of teaching poses massive challenges that lead to attrition among novice teachers. School communities often fail to provide adequate support to novice teachers to help them adapt to their new professional environments. In Saudi Arabia, attrition among novice teachers is a significant problem that hinders the development of the…

  15. The Effects of Mentor Instruction on Teaching Visual Supports to Novice, Special Education Teachers (United States)

    Mrstik, Samantha L.; Vasquez, Eleazar; Pearl, Cynthia


    The use of mentor teachers to sustain the longevity of a novice special education teacher is not a new tactic nor is the use of a mentor teacher's guidance in professional development for novice teachers. This study examines a new method of mentor teachers conducting professional development sessions for novice special educators through the use of…

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

    International Nuclear Information System (INIS)

    Chen Yumei


    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)

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

    International Nuclear Information System (INIS)

    Bütof, Rebecca; Baumann, Michael; Dubrovska, Anna


    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 electronic monitoring in clinical nursing research. (United States)

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


    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.

  19. NIHR Clinical Research Networks: what they do and how they help paediatric research. (United States)

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


    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

  20. Highlights of the 2012 Research Workshop: Using nutrigenomics and metabolomics in clinical nutrition research. (United States)

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


    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.

  1. Use of media for recruiting clinical research volunteers in Ecuador. (United States)

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


    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.

  2. Biomechanics of the thorax - research evidence and clinical expertise. (United States)

    Lee, Diane Gail


    Understanding the biomechanics of the thorax is critical for understanding its role in multiple conditions since the thorax is part of many integrated systems including the musculoskeletal, respiratory, cardiac, digestive and urogynecological. The thorax is also an integrated system within itself and an element of the whole body/person. Therefore, understanding the biomechanics of the thorax is fundamental to all forms of treatment for multiple conditions. The interpretation of movement examination findings depends on one's view of optimal biomechanics and the influential factors. This article will provide a synopsis of the current state of research evidence as well as observations from clinical experience pertaining to the biomechanics of the thorax in order to help clinicians organise this knowledge and facilitate evidence-based and informed management of the, often complex, patient with or without thoracic pain and impairment. The integrated systems model (ISM) will be introduced as a way to determine when the noted biomechanical findings are relevant to a patient's clinical presentation.

  3. Biomechanics of the thorax – research evidence and clinical expertise (United States)

    Lee, Diane Gail


    Understanding the biomechanics of the thorax is critical for understanding its role in multiple conditions since the thorax is part of many integrated systems including the musculoskeletal, respiratory, cardiac, digestive and urogynecological. The thorax is also an integrated system within itself and an element of the whole body/person. Therefore, understanding the biomechanics of the thorax is fundamental to all forms of treatment for multiple conditions. The interpretation of movement examination findings depends on one's view of optimal biomechanics and the influential factors. This article will provide a synopsis of the current state of research evidence as well as observations from clinical experience pertaining to the biomechanics of the thorax in order to help clinicians organise this knowledge and facilitate evidence-based and informed management of the, often complex, patient with or without thoracic pain and impairment. The integrated systems model (ISM) will be introduced as a way to determine when the noted biomechanical findings are relevant to a patient's clinical presentation. PMID:26309383

  4. Translating Research into Clinical Scale Manufacturing of Mesenchymal Stromal Cells

    Directory of Open Access Journals (Sweden)

    Karen Bieback


    Full Text Available It sounds simple to obtain sufficient numbers of cells derived from fetal or adult human tissues, isolate and/or expand the stem cells, and then transplant an appropriate number of these cells into the patient at the correct location. However, translating basic research into routine therapies is a complex multistep process which necessitates product regulation. The challenge relates to managing the expected therapeutic benefits with the potential risks and to balance the fast move to clinical trials with time-consuming cautious risk assessment. This paper will focus on the definition of mesenchymal stromal cells (MSCs, and challenges and achievements in the manufacturing process enabling their use in clinical studies. It will allude to different cellular sources, special capacities of MSCs, but also to current regulations, with a special focus on accessory material of human or animal origin, like media supplements. As cellular integrity and purity, formulation and lot release testing of the final product, validation of all procedures, and quality assurance are of utmost necessity, these topics will be addressed.

  5. The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC: experiences from a successful ERS Clinical Research Collaboration

    Directory of Open Access Journals (Sweden)

    James D. Chalmers


    To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areas To understand some of the key features of successful disease registries To review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC project in the past 5 years To understand the key research priorities identified by EMBARC for the next 5 years

  6. The contribution of licensing measures to the safety of novice drivers in Germany. On behalf of the Bundesanstalt für Strassenwesen BASt.

    NARCIS (Netherlands)

    Twisk, D.A.M.


    The Bundesanstalt fuer Strassenwesen (BASt) commissioned the SWOV Institute for Road Safety Research to review the literature on research into the effectiveness of: (1) post-qualification restrictive measures for novice drivers; and (2) of accompanied driving both as part of the driver training and

  7. After the clinic? Researching sexual health technology in context. (United States)

    Davis, Mark


    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.

  8. [Recent development of metabonomics and its applications in clinical research]. (United States)

    Li, Hao; Jiang, Ying; He, Fu-Chu


    In the post-genomic era, systems biology is central to the biological sciences. Functional genomics such as transcriptomics and proteomics can simultaneous determine massive gene or protein expression changes following drug treatment or other intervention. However, these changes can't be coupled directly to changes in biological function. As a result, metabonomics and its many pseudonyms (metabolomics, metabolic profiling, etc.) have exploded onto the scientific scene in the past several years. Metabonomics is a rapidly growing research area and a system approach for comprehensive and quantitative analysis of the global metabolites in a biological matrix. Analytical chemistry approach is necessary for the development of comprehensive metabonomics investigations. Fundamentally, there are two types of metabonomics approaches: mass-spectrometry (MS) based and nuclear magnetic resonance (NMR) methodologies. Metabonomics measurements provide a wealth of data information and interpretation of these data relies mainly on chemometrics approaches to perform large-scale data analysis and data visualization, such as principal and independent component analysis, multidimensional scaling, a variety of clustering techniques, and discriminant function analysis, among many others. In this review, the recent development of analytical and statistical techniques used in metabonomics is summarized. Major applications of metabonomics relevant to clinical and preclinical study are then reviewed. The applications of metabonomics in study of liver diseases, cancers and other diseases have proved useful both as an experimental tool for pathogenesis mechanism re-search and ultimately a tool for diagnosis and monitoring treatment response of these diseases. Next, the applications of metabonomics in preclinical toxicology are discussed and the role that metabonomics might do in pharmaceutical research and development is explained with special reference to the aims and achievements of the

  9. Reporting of clinical trials: a review of research funders' guidelines

    Directory of Open Access Journals (Sweden)

    Williamson Paula R


    Full Text Available Abstract Background Randomised controlled trials (RCTs represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias. Methods National and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias. Results Seventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported. Conclusion Our review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias

  10. Performing Systematic Literature Reviews with Novices: An Iterative Approach (United States)

    Lavallée, Mathieu; Robillard, Pierre-N.; Mirsalari, Reza


    Reviewers performing systematic literature reviews require understanding of the review process and of the knowledge domain. This paper presents an iterative approach for conducting systematic literature reviews that addresses the problems faced by reviewers who are novices in one or both levels of understanding. This approach is derived from…

  11. Solving Accounting Problems: Differences between Accounting Experts and Novices. (United States)

    Marshall, P. Douglas


    Performance of 90 accounting experts (faculty and practitioners) and 60 novices (senior accounting majors) was compared. Experts applied more accounting principles to solving problems. There were no differences in types of principles applied and no correlation between (1) principles applied and number of breadth comments or (2) importance placed…

  12. Taking on Critical Literacy: The Journey of Newcomers and Novices. (United States)

    Lewison, Mitzi; Flint, Amy Seely; Van Sluys, Katie


    Describes a portion of the authors' work with a group of elementary teachers during the first eight months of an ongoing study investigating critical literacy in classrooms. Examines the understandings and classroom practices of two groups of teachers: newcomers and novices. Provides insights into the concerns teachers have when they begin…

  13. Novice Counselors' Conceptualizations and Experiences of Therapeutic Relationships (United States)

    Schwing, Alison E.; LaFollette, Julie R.; Steinfeldt, Jesse A.; Wong, Y. Joel


    This qualitative study investigated three novice counselors' experiences and characterizations of therapeutic relationships. Thematic analyses of interviews and diaries revealed six common themes: (a) the centrality of supervision and training experiences to navigating interpersonal experiences with clients; (b) anxiety about counselors' roles in…

  14. A Model for Teaching Experiential Counseling Interventions to Novice Counselors. (United States)

    Cummings, Anne L.


    Describes model for teaching experiential interventions to novice counselors. Includes two experiential interventions that are focus for new model: two-chair approach based on Gestalt therapy principles and resolution of problematic reaction points. Cognitive, affective, and behavioral concepts of model are related to transfer of learning with the…

  15. Exploring the Evolving Professional Identity of Novice School Counselors (United States)

    Bamgbose, Olamojiba Omolara


    The study employed a grounded theory approach to explore the evolving professional identity of novice school counselors. Participants, who are currently employed as school counselors at the elementary, middle, or high school level with 1-4 years' experience, were career changers from other helping professions and graduates from an intensive school…

  16. Teaching Physics Novices at University: A Case for Stronger Scaffolding (United States)

    Lindstrom, Christine; Sharma, Manjula D.


    In 2006 a new type of tutorial, called Map Meeting, was successfully trialled with novice first year physics students at the University of Sydney, Australia. Subsequently, in first semester 2007 a large-scale experiment was carried out with 262 students who were allocated either to the strongly scaffolding Map Meetings or to the less scaffolding…

  17. Systematic Literature Review Protocol: Teaching Novices Programming Using Robots (United States)

    Major, Louis


    Teaching computer programming to novices is a difficult task due to the complex nature of the subject, as negative stereotypes are associated with programming and because introductory programming courses often fail to encourage student understanding. This Protocol outlines the plan that is to be followed in order to investigate the effectiveness…

  18. Rural Rides in Queensland: Travels with Novice Teaching Principals (United States)

    Clarke, Simon; Stevens, Elizabeth; Wildy, Helen


    This article is concerned with the nature of novice teaching principals' interactions in Queensland rural communities. Stories selected from case accounts are used to provide insights into the teaching principals' interrelationship with the community. The article concludes with a discussion of some implications for practice suggested by these…

  19. Supporting Novice Special Education Teachers through Quality Professional Development (United States)

    Tate, Mary E.


    The special education teaching environment is a teaching environment with unique duties that often challenge novice special education teachers. The purpose of this qualitative case study was to gain clarity of the work environment of special education teachers to uncover professional development practices that would work to support them. Research…

  20. Novice Teachers' Case Dilemmas: Surprising Perspectives Related to Diversity. (United States)

    Mastrilli, Thomas; Sardo-Brown, Deborah; Hinson, Stephanie

    This study described novice teachers' case dilemmas, analyzing them for assumptions made by teachers about teaching and learning as well as for solutions to the dilemmas. Twenty-one of the thirty-six dilemmas emphasized either minority students, students of low socioeconomic status, or students from single-parent households. Among the issues…

  1. Do young novice drivers overestimate their driving skills?

    NARCIS (Netherlands)

    Craen, S. de Twisk, D.A.M. Hagenzieker, M.P. Elffers, H. & Brookhuis, K.A.


    In this study the authors argue that, in order to sufficiently adapt to task demands in traffic, drivers have to make an assessment of their own driving skills. There are indications that drivers in general, and novice drivers in particular, overestimate their driving skills. The objective of this

  2. The Metamorphosis of Industrial Designers from Novices to Experts (United States)

    Wong, Ju-Joan; Chen, Po-Yu; Chen, Chun-Di


    Professional training for designers is crucial in the field of design studies. The characteristics of novices versus those of expert designers have been identified in the literature; however, studies exploring the issue of professional training processes in the actual workplace are not well developed. Our study addresses the topic by using…

  3. Exploring novice nurses' needs regarding their work-related health: a qualitative study. (United States)

    Ketelaar, Sarah M; Nieuwenhuijsen, Karen; Frings-Dresen, Monique H W; Sluiter, Judith K


    To investigate Dutch novice nurses' experiences and needs regarding occupational health support to prevent work-related health problems and to keep them well-functioning. A qualitative interview study was conducted with six nursing students and eight newly qualified nurses. The interviews covered three topics: experiences with the link between work and health, received occupational health support, and occupational health support needs. Data were analysed using a grounded theory approach. Participants reported experiences with work-related health problems early in their career and described experiences with how health problems lead to suboptimal work functioning. Occupational health support needs included knowledge and psychosocial support during nursing education, e.g. through paying attention to dealing with shift work, or career counselling. Also, they reported a need for knowledge and psychosocial support at the start of their clinical placement or new job in the hospital, e.g. information from occupational health services or having a mentor. Furthermore, they reported that occupational health support requires a more general place at work through offering knowledge, e.g. tailored advice on proper lifting position; psychosocial support, e.g. positive team atmosphere; and physical support, e.g. suitable preventive measures. Occupational health support for novice nurses is important, since they already experience work-related health problems and suboptimal work functioning due to health problems early in their career and while still in training to be a nurse. Novice nurses should be given more knowledge and support to help them stay healthy and well-functioning in their work. This is a joint responsibility of nurse educators, the employer and occupational health services.

  4. 78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug... (United States)


    ...) Modernizing FDA's Clinical Trials/BIMO Programs; (3) What FDA Expects in a Pharmaceutical Clinical Trial; (4) Medical Device Aspects of Clinical Research; (5) Adverse Event Reporting--Science, Regulation, Error, and...

  5. The Novice-Expert Continuum in Astronomy Knowledge (United States)

    Bryce, T. G. K.; Blown, E. J.


    The nature of expertise in astronomy was investigated across a broad spectrum of ages and experience in China and New Zealand. Five hypotheses (capable of quantification and statistical analysis) were used to probe types of expertise identified by previous researchers: (a) domain-specific knowledge-skill in the use of scientific vocabulary and language and recognising relationships between concepts in linguistic and schematic forms; (b) higher-order theory in terms of conceptual structure and enriched scientific knowledge and reasoning; with an expectation of cultural similarity. There were 993 participants in all, age 3-80 years, including 68 junior school pupils; 68 pre-school pupils; 112 middle-school students; 109 high-school students; 79 physics undergraduates; 60 parents; 136 pre-service primary teachers; 131 pre-service secondary teachers; 72 primary teachers; 78 secondary teachers; 50 amateur astronomers and astronomy educators; and 30 astronomers and physicists; with approximately equal numbers of each group in both cultures; and of boys and girls in the case of children. For them, the methodology utilised Piagetian interviews with three media (verbal language, drawing, play-dough modelling), and for adults a questionnaire inviting responses in writing and drawing was used. The data from each group were categorised into ordinal scales and then analysed by means of Kolmogorov-Smirnov two-sample tests. The findings supported the hypotheses with evidence of all forms of expertise increasing with experience in both cultures (α level 0.05). The relative gains, overlaps and deficits in expertise across the novice-expert continuum are explored in detail.

  6. The qualitative interview and challenges for clinicians undertaking research: a personal reflection. (United States)

    Fisher, Karin


    Drawing on my doctoral experience the aim of this article is to present my transition from practitioner to novice researcher and the challenges I encountered when undertaking qualitative in-depth interviews. The contents of my research diary were coded for words, sentences and paragraphs and were then grouped into themes and subsequently organised into concepts and categories. The analysis identified one core category: 'changing states: learning to become a researcher'. The related categories included 'guessing responses', 'confusing boundaries' and 'revealing hidden concepts'. These concepts provide a description of how I learnt to become a researcher and became a changed state. The paper provides practitioners with practical examples of my transition from practitioner to novice researcher. I offer some tips for practitioners who wish to undertake research in their clinical role.

  7. Revisioning Clinical Psychology: Integrating Cultural Psychology into Clinical Research and Practice with Portuguese Immigrants (United States)

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


    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

  8. Using research to transform care for women veterans: advancing the research agenda and enhancing research-clinical partnerships. (United States)

    Yano, Elizabeth M; Bastian, Lori A; Bean-Mayberry, Bevanne; Eisen, Seth; Frayne, Susan; Hayes, Patricia; Klap, Ruth; Lipson, Linda; Mattocks, Kristin; McGlynn, Geraldine; Sadler, Anne; Schnurr, Paula; Washington, Donna L


    The purpose of this paper is to report on the outcomes of the 2010 VA Women's Health Services Research Conference, which brought together investigators interested in pursuing research on women veterans and women in the military with leaders in women's health care delivery and policy within and outside the VA, to significantly advance the state and future direction of VA women's health research and its potential impacts on practice and policy. Building on priorities assembled in the previous VA research agenda (2004) and the research conducted in the intervening six years, we used an array of approaches to foster research-clinical partnerships that integrated the state-of-the-science with the informational and strategic needs of senior policy and practice leaders. With demonstrated leadership commitment and support, broad field-based participation, strong interagency collaboration and a push to accelerate the move from observational to interventional and implementation research, the Conference provided a vital venue for establishing the foundation for a new research agenda. In this paper, we provide the historical evolution of the emergence of women veterans' health services research and an overview of the research in the intervening years since the first VA women's health research agenda. We then present the resulting VA Women's Health Research Agenda priorities and supporting activities designed to transform care for women veterans in six broad areas of study, including access to care and rural health; primary care and prevention; mental health; post deployment health; complex chronic conditions, aging and long-term care; and reproductive health. Published by Elsevier Inc.

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

    DEFF Research Database (Denmark)

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


    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...

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


    ZHYLA M.I.


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

    Springate, David A; Kontopantelis, Evangelos; Ashcroft, Darren M; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David


    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.

  12. Understanding clinical reasoning in osteopathy: a qualitative research approach


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


    Background Clinical reasoning has been described as a process that draws heavily on the knowledge, skills and attributes that are particular to each health profession. However, the clinical reasoning processes of practitioners of different disciplines demonstrate many similarities, including hypothesis generation and reflective practice. The aim of this study was to understand clinical reasoning in osteopathy from the perspective of osteopathic clinical educators and the extent to which it wa...

  13. How Can a Clinical Research Approach Contribute to Knowledge-Building for the Teaching Profession? (United States)

    Bulterman-Bos, Jacquelien


    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…

  14. 78 FR 70102 - Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Development Officer through the Director of the Clinical Science Research and Development Service on the...

  15. 78 FR 41198 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and.... The Committee advises the Chief Research and Development Officer through the Director of the Clinical...

  16. 77 FR 72438 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... through the Director of the Clinical Science Research and Development Service on the relevance and...

  17. 78 FR 53015 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and...

  18. Thinking through ethics : the processes of ethical decision-making by novice and expert American sign language interpreters


    Mendoza, Mary Elizabeth


    In the course of their work, sign language interpreters are faced with ethical dilemmas that require prioritizing competing moral beliefs and views on professional practice. There are several decision-making models, however, little research has been done on how sign language interpreters learn to identify and make ethical decisions. Through surveys and interviews on ethical decision-making, this study investigates how expert and novice interpreters discuss their ethical decision-making proces...

  19. Image-Seeking Preferences Among Undergraduate Novice Researchers

    Directory of Open Access Journals (Sweden)

    Laurie M. Bridges


    Full Text Available Objective – This study investigated the image-seeking preferences of university freshmen to gain a better understanding of how they search for pictures for assignments.Methods – A survey was emailed to a random sample of 1,000 freshmen enrolled at Oregon State University in the fall of 2009. A total of 63 surveys were returned.Results – The majority of students indicated they would use Google to find a picture. Nineteen respondents said they would use a library, librarians, and/or archives.Conclusions – The results indicate the majority of students in our study would use Google to find an image for coursework purposes; yet the students who suggested they would use Google did not mention evaluating the images they might find or have concerns about copyright issues. Undergraduate students would benefit from having visual literacy integrated into standard information literacy instruction to help them locate, evaluate, and legally use the images they find online. In addition, libraries, librarians, archivists, and library computer programmers should work to raise the rankings of library digital photo collections in online search engines like Google.

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

    Directory of Open Access Journals (Sweden)

    Sanz Nuria


    Full Text Available 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

  1. 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


    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

  2. 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.

  3. The effect of virtual endoscopy simulator training on novices: a systematic review.

    Directory of Open Access Journals (Sweden)

    Weiguang Qiao

    Full Text Available BACKGROUND: Advances in virtual endoscopy simulators have paralleled an interest in medical simulation for gastrointestinal endoscopy training. OBJECTIVE: The primary objective was to determine whether the virtual endoscopy simulator training could improve the performance of novices. DESIGN: A systematic review. SETTING: Randomized controlled trials (RCTs that compared virtual endoscopy simulator training with bedside teaching or any other intervention for novices were collected. PATIENTS: Novice endoscopists. INTERVENTIONS: The PRISMA statement was followed during the course of the research. The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and ScienceDirect were searched (up to July 2013. Data extraction and assessment were independently performed. MAIN OUTCOME MEASUREMENTS: Independent procedure completion, total procedure time and required assistance. RESULTS: Fifteen studies (n = 354 were eligible for inclusion: 9 studies designed for colonoscopy training, 6 for gastroscopy training. For gastroscopy training, procedure completed independently was reported in 87.7% of participants in simulator training group compared to 70.0% of participants in control group (1 study; 22 participants; RR 1.25; 95% CI 1.13-1.39; P<0.0001. For colonoscopy training, procedure completed independently was reported in 89.3% of participants in simulator training group compared to 88.9% of participants in control group (7 study; 163 participants; RR 1.10; 95% CI 0.88-1.37; P = 0.41; I(2 = 85%. LIMITATIONS: The included studies are quite in-homogeneous with respect to training schedule and procedure. CONCLUSIONS: Virtual endoscopy simulator training might be effective for gastroscopy, but so far no data is available to support this for colonoscopy.

  4. Needs assessment for collaborative network in pediatric clinical research and education. (United States)

    Ishiguro, Akira; Sasaki, Hatoko; Yahagi, Naohisa; Kato, Hitoshi; Kure, Shigeo; Mori, Rintaro


    A collaborative network for pediatric research has not been fully established in Japan. To identify the network infrastructure, we conducted a survey on the support and education for clinical research currently available in children's hospitals. In November 2014, a 27-question survey was distributed to 31 hospitals belonging to the Japanese Association of Children's Hospitals and Related Institutions (JACHRI) to assess clinical research support, research education, research achievements, and their expectations. All the hospitals responded to the survey. Overall, 74.2% of hospitals had clinical research support divisions. Although all hospitals had ethics committees, manager, intellectual property management unit, biostatistician, and English-language editor. Seven hospitals had education programs for clinical research. The number of seminars and workshops for clinical research had significant correlations with the number of physicians (r = 0.927), pediatricians (r = 0.922), and clinical trial management physicians (r = 0.962). There was a significant difference in the number of clinical trials initiated by physicians between hospitals with research education programs and those without (P leader to establish a collaborative network for clinical research. Important factors for creating a collaborative system for pediatric research in Japan were identified. Human resources to support clinical research are a key factor to improve clinical research education and research achievements. © 2016 Japan Pediatric Society.

  5. Nurse awareness of clinical research: a survey in a Japanese University Hospital (United States)


    Background Clinical research plays an important role in establishing new treatments and improving the quality of medical practice. Since the introduction of the concept of clinical research coordinators (CRC) in Japan, investigators and CRC work as a clinical research team that coordinates with other professionals in clinical trials leading to drug approval (registration trials). Although clinical nurses collaborate with clinical research teams, extended clinical research teams that include clinical nurses may contribute to the ethical and scientific pursuit of clinical research. Methods As knowledge of clinical research is essential for establishing an extended clinical research team, we used questionnaires to survey the knowledge of clinical nurses at Tokushima University Hospital. Five-point and two-point scales were used. Questions as for various experiences were also included and the relationship between awareness and experiences were analyzed. Results Among the 597 nurses at Tokushima University Hospital, 453 (75.9%) responded to the questionnaires. In Japan, registration trials are regulated by pharmaceutical affairs laws, whereas other types of investigator-initiated research (clinical research) are conducted based on ethical guidelines outlined by the ministries of Japan. Approximately 90% of respondents were aware of registration trials and clinical research, but less than 40% of the nurses were aware of their difference. In clinical research terminology, most respondents were aware of informed consent and related issues, but ≤50% were aware of other things, such as the Declaration of Helsinki, ethical guidelines, Good Clinical Practice, institutional review boards, and ethics committees. We found no specific tendency in the relationship between awareness and past experiences, such as nursing patients who were participating in registration trials and/or clinical research or taking a part in research involving patients as a nursing student or a nurse

  6. Continuing Education in Research Ethics for the Clinical Nurse. (United States)

    Jeffers, Brenda Recchia


    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)

  7. Concept mapping in a critical care orientation program: a pilot study to develop critical thinking and decision-making skills in novice nurses. (United States)

    Wahl, Stacy E; Thompson, Anita M


    Newly graduated registered nurses who were hired into a critical care intensive care unit showed a lack of critical thinking skills to inform their clinical decision-making abilities. This study evaluated the effectiveness of concept mapping as a teaching tool to improve critical thinking and clinical decision-making skills in novice nurses. A self-evaluation tool was administered before and after the learning intervention. The 25-item tool measured five key indicators of the development of critical thinking skills: problem recognition, clinical decision-making, prioritization, clinical implementation, and reflection. Statistically significant improvements were seen in 10 items encompassing all five indicators. Concept maps are an effective tool for educators to use in assisting novice nurses to develop their critical thinking and clinical decision-making skills. Copyright 2013, SLACK Incorporated.

  8. A model for integrating clinical care and basic science research, and pitfalls of performing complex research projects for addressing a clinical challenge. (United States)

    Steck, R; Epari, D R; Schuetz, M A


    The collaboration of clinicians with basic science researchers is crucial for addressing clinically relevant research questions. In order to initiate such mutually beneficial relationships, we propose a model where early career clinicians spend a designated time embedded in established basic science research groups, in order to pursue a postgraduate qualification. During this time, clinicians become integral members of the research team, fostering long term relationships and opening up opportunities for continuing collaboration. However, for these collaborations to be successful there are pitfalls to be avoided. Limited time and funding can lead to attempts to answer clinical challenges with highly complex research projects characterised by a large number of "clinical" factors being introduced in the hope that the research outcomes will be more clinically relevant. As a result, the complexity of such studies and variability of its outcomes may lead to difficulties in drawing scientifically justified and clinically useful conclusions. Consequently, we stress that it is the basic science researcher and the clinician's obligation to be mindful of the limitations and challenges of such multi-factorial research projects. A systematic step-by-step approach to address clinical research questions with limited, but highly targeted and well defined research projects provides the solid foundation which may lead to the development of a longer term research program for addressing more challenging clinical problems. Ultimately, we believe that it is such models, encouraging the vital collaboration between clinicians and researchers for the work on targeted, well defined research projects, which will result in answers to the important clinical challenges of today. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

  9. Parent involvement in novice teen driving: a review of the literature. (United States)

    Simons-Morton, B; Ouimet, M C


    Motor vehicle crashes remain elevated among novice teen drivers for at least several years after licensure. Licensing policies and driver education are the two primary countermeasures employed to decrease young driver crash risks. Graduated driver licensing policies have proved to be effective in reducing crash rates where evaluated. Driver education is an essential part of teaching teens the rules of the road and operating a vehicle, but requires few hours of professional driver training, relying mainly on parents to provide most of the supervised practice driving teens obtain before independent driving licensure. The few studies that have been conducted to increase parent supervised practice driving have not shown positive results. Moreover, it is unclear that increases in practice would improve independent driving safety. Recent research has shown that parent management of the early independent driving experience of novice teens improves safety outcomes, and other research has shown that it is possible to increase parent management practices. This paper provides a review of the literature on parent involvement in supervised practice and independent driving, and efforts to increase parental management.

  10. A narrative study of novice elementary teachers' perceptions of science instruction (United States)

    Harrell, Roberta

    It is hoped that, once implemented, the Next Generation Science Standards (NGSS) will engage students more deeply in science learning and build science knowledge sequentially beginning in Kindergarten (NRC, 2013). Early instruction is encouraged but must be delivered by qualified elementary teachers who have both the science content knowledge and the necessary instructional skills to teach science effectively to young children (Ejiwale, 2012, Spencer, Vogel, 2009, Walker, 2011). The purpose of this research study is to gain insight into novice elementary teachers' perceptions of science instruction. This research suggests that infusion of constructivist teaching in the elementary classroom is beneficial to the teacher's instruction of science concepts to elementary students. Constructivism is theory that learning is centered on the learner constructing new ideas or concepts built upon their current/past knowledge (Bruner, 1966). Based on this theory, it is recommended that the instructor should try to encourage students to discover principles independently; essentially the instructor presents the problem and lets students go (Good & Brophy, 2004). Discovery learning, hands-on, experimental, collaborative, and project-based learning are all approaches that use constructivist principles. The NGSS are based on constructivist principles. This narrative study provides insight into novice elementary teachers' perceptions of science instruction considered through the lens of Constructivist Theory (Bruner, 1960).

  11. Recruitment methods for survey research: Findings from the Mid-South Clinical Data Research Network. (United States)

    Heerman, William J; Jackson, Natalie; Roumie, Christianne L; Harris, Paul A; Rosenbloom, S Trent; Pulley, Jill; Wilkins, Consuelo H; Williams, Neely A; Crenshaw, David; Leak, Cardella; Scherdin, Jon; Muñoz, Daniel; Bachmann, Justin; Rothman, Russell L; Kripalani, Sunil


    The objective of this study was to report survey response rates and demographic characteristics of eight recruitment approaches to determine acceptability and effectiveness of large-scale patient recruitment among various populations. We conducted a cross sectional analysis of survey data from two large cohorts. Patients were recruited from the Mid-South Clinical Data Research Network using clinic-based recruitment, research registries, and mail, phone, and email approaches. Response rates are reported as patients who consented for the survey divided by the number of eligible patients approached. We contacted more than 90,000 patients and 13,197 patients completed surveys. Median age was 56.3years (IQR 40.9, 67.4). Racial/ethnic distribution was 84.1% White, non-Hispanic; 9.9% Black, non-Hispanic; 1.8% Hispanic; and 4.0% other, non-Hispanic. Face-to-face recruitment had the highest response rate of 94.3%, followed by participants who "opted-in" to a registry (76%). The lowest response rate was for unsolicited emails from the clinic (6.1%). Face-to-face recruitment enrolled a higher percentage of participants who self-identified as Black, non-Hispanic compared to other approaches (18.6% face-to-face vs. 8.4% for email). Technology-enabled recruitment approaches such as registries and emails are effective for recruiting but may yield less racial/ethnic diversity compared to traditional, more time-intensive approaches. Copyright © 2017. Published by Elsevier Inc.

  12. Merging genomic and phenomic data for research and clinical impact. (United States)

    Shublaq, Nour W; Coveney, Peter V


    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.

  13. [Problems in career planning for novice medical technologists in Japanese national hospitals]. (United States)

    Ogasawara, Shu; Tsutaya, Shoji; Akimoto, Hiroyuki; Kojima, Keiya; Yabaka, Hiroyuki


    Skills and knowledge regarding many different types of test are required for medical technologists (MTs) to provide accurate information to help doctors and other medical specialists. In order to become an efficient MT, specialized training programs are required. Certification in specialized areas of clinical laboratory sciences or a doctoral degree in medical sciences may help MTs to realize career advancement, a higher earning potential, and expand the options in their career. However, most young MTs in national university hospitals are employed as part-time workers on a three-year contract, which is too short to obtain certifications or a doctoral degree. We have to leave the hospital without expanding our future. We need to take control of our own development in order to enhance our employability within the period. As teaching and training hospitals, national university hospitals in Japan are facing a difficult dilemma in nurturing MTs. I hope, as a novice medical technologist, that at least university hospitals in Japan create an appropriate workplace environment for novice MTs.

  14. The working experiences of novice psychiatric nurses in Taiwanese culture: a phenomenological study. (United States)

    Hung, B J; Huang, X Y; Cheng, J F; Wei, S J; Lin, M J


    Novice psychiatric nurses experience heavy workloads, insufficient training and support in Taiwan. The aim of this study was to understand the working experiences of novice psychiatric nurses during their first year in a clinical setting. A qualitative phenomenological approach, using semi-structured face-to-face interviews was used. Narratives were analyzed using Colaizzi's seven-step method. Data saturation was reached after interviews were conducted with 15 nurses based on the purposive sampling. Four themes and eight sub-themes were identified: struggling (lacking a sense of security and competency), emulating (learning the process of interaction with clients and families, learning an appropriate role from nursing staff), prevailing (developing core competency, creating a therapeutic environment) and belonging (coping with the job, becoming a part of the psychiatric nursing staff). The findings from this study demonstrate that nurses are often inadequately prepared for psychiatric nursing. They have little understanding of mental illness, are unable to communicate appropriately with clients and struggle to cope with the conditions. Our study supports the importance for helping nurses to improve their essential knowledge and skills for coping with the job and providing good quality care, particularly in the first year. © 2014 John Wiley & Sons Ltd.

  15. A prospective study on time to recovery in 254 injured novice runners.

    Directory of Open Access Journals (Sweden)

    Rasmus Oestergaard Nielsen

    Full Text Available Describe the diagnoses and the time to recovery of running-related injuries in novice runners.Prospective cohort study on injured runners.This paper is a secondary data analysis of a 933-person cohort study (DANO-RUN aimed at characterizing risk factors for injury in novice runners. Among those sustaining running-related injuries, the types of injuries and time to recovery is described in the present paper. All injured runners were diagnosed after a thorough clinical examination and then followed prospectively during their recovery. If they recovered completely from injury, time to recovery of each injury was registered.A total of 254 runners were injured. The proportion of runners diagnosed with medial tibial stress syndrome was 15%, 10% for patellofemoral pain, 9% for medial meniscal injury, 7% for Achilles tendinopathy and 5% for plantar fasciitis. Among the 220 runners (87% recovering from their injury, the median time to recovery was 71 days (minimum  = 9 days, maximum  = 617 days.Medial tibial stress syndrome was the most common injury followed by patellofemoral pain, medial meniscal injury and Achilles tendinopathy. Half of the injured runners were unable to run 2×500 meters without pain after 10 weeks. Almost 5% of the injured runners received surgical treatment.

  16. Bridging basic science and clinical research: the EASL Monothematic Conference on Translational Research in Viral Hepatitis. (United States)

    Boettler, Tobias; Moradpour, Darius; Thimme, Robert; Zoulim, Fabien


    The EASL Monothematic Conference on Translational Research in Viral Hepatitis brought together a group of leading scientists and clinicians working on both, basic and clinical aspects of viral hepatitis, thereby building bridges from bench to bedside. This report recapitulates the presentations and discussions at the conference held in Lyon, France on November 29-30, 2013. In recent years, great advances have been made in the field of viral hepatitis, particularly in hepatitis C virus (HCV) infection. The identification of IL28B genetic polymorphisms as a major determinant for spontaneous and treatment-induced HCV clearance was a seminal discovery. Currently, hepatologists are at the doorstep of even greater advances, with the advent of a wealth of directly acting antivirals (DAAs) against HCV. Indeed, promising results have accumulated over the last months and few years, showing sustained virological response (SVR) rates of up to 100% with interferon-free DAA combination therapies. Thus, less than 25 years after its identification, HCV infection may soon be curable in the vast majority of patients, highlighting the great success of HCV research over the last decades. However, viral hepatitis and its clinical complications such as liver cirrhosis and hepatocellular carcinoma (HCC) remain major global challenges. New therapeutic strategies to tackle hepatitis B virus (HBV) and hepatitis D virus (HDV) infection are needed, as current therapies have undeniable limitations. Nucleoside/nucleotide analogues (NUC) can efficiently control HBV replication and reduce or even reverse liver damage. However, these drugs have to be given for indefinite periods in most patients to maintain virological and biochemical responses. Although sustained responses off treatment can be achieved by treatment with (pegylated) interferon-α, only about 10-30% of patients effectively resolve chronic hepatitis B. It was the goal of this conference to review the progress made over the last

  17. Sustained attention in skilled and novice martial arts athletes: a study of event-related potentials and current sources. (United States)

    Sanchez-Lopez, Javier; Silva-Pereyra, Juan; Fernandez, Thalia


    Background. Research on sports has revealed that behavioral responses and event-related brain potentials (ERP) are better in expert than in novice athletes for sport-related tasks. Focused attention is essential for optimal athletic performance across different sports but mainly in combat disciplines. During combat, long periods of focused attention (i.e., sustained attention) are required for a good performance. Few investigations have reported effects of expertise on brain electrical activity and its neural generators during sport-unrelated attention tasks. The aim of the present study was to assess the effect of expertise (i.e., skilled and novice martial arts athletes) analyzing the ERP during a sustained attention task (Continuous Performance Task; CPT) and the cortical three-dimensional distribution of current density, using the sLORETA technique. Methods. CPT consisted in an oddball-type paradigm presentation of five stimuli (different pointing arrows) where only one of them (an arrow pointing up right) required a motor response (i.e., target). CPT was administered to skilled and novice martial arts athletes while EEG were recorded. Amplitude ERP data from target and non-target stimuli were compared between groups. Subsequently, current source analysis for each ERP component was performed on each subject. sLORETA images were compared by condition and group using Statistical Non-Parametric Mapping analysis. Results. Skilled athletes showed significant amplitude differences between target and non-target conditions in early ERP components (P100 and P200) as opposed to the novice group; however, skilled athletes showed no significant effect of condition in N200 but novices did show a significant effect. Current source analysis showed greater differences in activations in skilled compared with novice athletes between conditions in the frontal (mainly in the Superior Frontal Gyrus and Medial Frontal Gyrus) and limbic (mainly in the Anterior Cingulate Gyrus) lobes

  18. 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


    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....

  19. Nursing Faculty Professional Development: A Study Using the National League for Nursing (NLN) Core Competencies for Nurse Educators for Development of Novice to Expert Nurse Educators (United States)

    Luoma, Kari L.


    The purpose of this quantitative research study was to identify core competencies that are most significant for nursing faculty to develop as they transition from novice to expert faculty. Professional development in a systematic approach may guide faculty to learn what is significant as they progress in the nurse faculty role. A quantitative…

  20. High eccentric hip abduction strength reduces the risk of developing patellofemoral pain among novice runners initiating a self-structured running program

    DEFF Research Database (Denmark)

    Ramskov, Daniel; Barton, Christian; Nielsen, Rasmus O


    Study Design Observational prospective cohort study with 1-year follow-up. Objectives To investigate the relationship between eccentric hip abduction strength and the development of patellofemoral pain (PFP) in novice runners, during a self-structured running regime. Background Recent research...

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


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


    A simple extension of standard meta-analysis 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

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


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


    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

  3. Practice databases and their uses in clinical research. (United States)

    Tierney, W M; McDonald, C J


    A few large clinical information databases have been established within larger medical information systems. Although they are smaller than claims databases, these clinical databases offer several advantages: accurate and timely data, rich clinical detail, and continuous parameters (for example, vital signs and laboratory results). However, the nature of the data vary considerably, which affects the kinds of secondary analyses that can be performed. These databases have been used to investigate clinical epidemiology, risk assessment, post-marketing surveillance of drugs, practice variation, resource use, quality assurance, and decision analysis. In addition, practice databases can be used to identify subjects for prospective studies. Further methodologic developments are necessary to deal with the prevalent problems of missing data and various forms of bias if such databases are to grow and contribute valuable clinical information.

  4. The effectiveness of a preconditioning programme on preventing running-related injuries in novice runners: a randomised controlled trial. (United States)

    Bredeweg, Steef W; Zijlstra, Sjouke; Bessem, Bram; Buist, Ida


    There is no consensus on the aetiology and prevention of running-related injuries in runners. Preconditioning studies among different athlete populations show positive effects on the incidence of sports injuries. A 4-week preconditioning programme in novice runners will reduce the incidence of running-related injuries. Randomised controlled clinical trial; level of evidence, 1. Novice runners (N=432) prepared for a four-mile recreational running event. Participants were allocated to the 4-week preconditioning (PRECON) group (N=211) or the control group (N=221). The PRECON group started a 4-week training programme, prior to the running programme, with walking and hopping exercises. After the 4-week period both groups started a 9-week running programme. In both groups information was registered on running exposure and running-related injuries (RRIs) using an internet-based running log. Primary outcome measure was RRIs per 100 runners. An RRI was defined as any musculoskeletal complaint of the lower extremity or lower back causing restriction of running for at least a week. The incidence of RRIs was 15.2% in the PRECON group and 16.8% in the control group. The difference in RRIs between the groups was not significant (χ(2)=0.161, df=1, p=0.69). This prospective study demonstrated that a 4-week PRECON programme with walking and hopping exercises had no influence on the incidence of RRIs in novice runners.

  5. Structural equation modeling assessing relationship between mathematics beliefs, teachers' attitudes and teaching practices among novice teachers in Malaysia (United States)

    Borhan, Noziati; Zakaria, Effandi


    This quantitative study was conducted to investigate the perception level of novice teachers about mathematics belief, teachers' attitude towards mathematics and teaching practices of mathematics in the classroom. In addition, it also aims to identify whether there is a correspondence model with the data obtained and to identify the relationship between the variables of beliefs, attitudes and practices among novice teachers in Malaysia. A total of 263 primary novice teachers throughout the country were involved in this study were selected randomly. Respondents are required to provide a response to the questionnaire of 66 items related to mathematics beliefs, attitudes and practices of the teaching mathematics. There are ten sub-factors which have been established in this instrument for three major constructs using a Likert scale rating of five points. The items of the constructs undergo the exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) procedure involve of unidimensionality test, convergent validity, construct validity and discriminant validity. Descriptive statistics were used to describe the frequency, percentage, the mean and standard deviation for completing some research questions that have been expressed. As for inferential statistical analysis, the researchers used structural equation modeling (SEM) to answer the question of correspondents model and the relationship between these three variables. The results of the study were found that there exist a correspondence measurement and structural model with the data obtained. While the relationship between variable found that mathematics beliefs have a significant influence on teachers' attitudes towards mathematics as well as the relationship between the attitudes with teaching practices. Meanwhile, mathematics belief had no significant relationship with mathematics teaching practices among novice teachers in Malaysia.

  6. Normative values of eccentric hip abduction strength in novice runners

    DEFF Research Database (Denmark)

    Ramskov, D; Pedersen, M B; Kastrup, K


    normative values of maximal eccentric hip abduction strength in novice runners. METHODS: Novice healthy runners (n = 831) were recruited through advertisements at a hospital and a university. Maximal eccentric hip abduction strength was measured with a hand-held dynamometer. The demographic variables...... was found, p values were identified using a regression equation adjusting for age and gender. Based on this, the equation to calculate normative values for relative eccentric hip abduction strength became: (1.600 + (age * -0.005) + (gender (1 = male / 0 = female) * 0.215) ± 1 or 2 * 0......PURPOSE: Low eccentric strength of the hip abductors, might increase the risk of patellofemoral pain syndrome and iliotibial band syndrome in runners. No normative values for maximal eccentric hip abduction strength have been established. Therefore the purpose of this study was to establish...

  7. Exploring physics concepts among novice teachers through CMAP tools (United States)

    Suprapto, N.; Suliyanah; Prahani, B. K.; Jauhariyah, M. N. R.; Admoko, S.


    Concept maps are graphical tools for organising, elaborating and representing knowledge. Through Cmap tools software, it can be explored the understanding and the hierarchical structuring of physics concepts among novice teachers. The software helps physics teachers indicated a physics context, focus questions, parking lots, cross-links, branching, hierarchy, and propositions. By using an exploratory quantitative study, a total 13-concept maps with different physics topics created by novice physics teachers were analysed. The main differences of scoring between lecturer and peer-teachers’ scoring were also illustrated. The study offered some implications, especially for physics educators to determine the hierarchical structure of the physics concepts, to construct a physics focus question, and to see how a concept in one domain of knowledge represented on the map is related to a concept in another domain shown on the map.

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


    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.

  9. Antibody Characterization Lab | Office of Cancer Clinical Proteomics Research (United States)

    The Antibody Characterization Lab (ACL), an intramural reference laboratory located at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, thoroughly characterizes monoclonal antibodies or other renewable affinity binding reagents for use in cancer related research.

  10. 77 FR 31072 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... Development Officer through the Director of the Clinical Science Research and Development Service on the... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  11. 76 FR 19189 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  12. 75 FR 79446 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... Officer through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  13. 76 FR 65781 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  14. 76 FR 73781 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... Officer through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  15. 75 FR 28686 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (United States)


    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...



    Pradhan, Anuj; Masserang, Kathleen M.; Divekar, Gautam; Reagan, Ian; Thomas, F. Dennis; Blomberg, Richard; Pollatsek, Alexander; Fisher, Donald


    All programs assessing attention maintenance inside the vehicle have required eye trackers and either a driving simulator or a specially equipped field vehicle. Ideally, one would like a way to assess attention maintenance that could be implemented on a desktop PC. Additionally, one would like to have a program that could be used to train novice drivers to maintain their attention more safely on the forward roadway. An experiment was run (a) to determine whether a program FOCAL (Focused Conce...

  17. Usability Issues in the Design of Novice Programming Systems, (United States)


    lists this as a design principle for novice programming environments. In traditional compiled languages, beginners are also confused by the need to...programming task external knowledge that might interfere with correct under- standing of the language. Most beginner programming errors can be...language for text editing, but [Curtis 1988] found that a textual pseudocode and graphical flowcharts were both bet- ter than natural language in program

  18. Simplifying the writing process for the novice writer. (United States)

    Redmond, Mary Connie


    Nurses take responsibility for reading information to update their professional knowledge and to meet relicensure requirements. However, nurses are less enthusiastic about writing for professional publication. This article explores the reluctance of nurses to write, the reasons why writing for publication is important to the nursing profession, the importance of mentoring to potential writers, and basic information about simplifying the writing process for novice writers. Copyright 2002 by American Society of PeriAnesthesia Nurses.

  19. Listening to music primes space: pianists, but not novices, simulate heard actions. (United States)

    Taylor, J Eric T; Witt, Jessica K


    Musicians sometimes report twitching in their fingers or hands while listening to music. This anecdote could be indicative of a tendency for auditory-motor co-representation in musicians. Here, we describe two studies showing that pianists (Experiment 1), but not novices (Experiment 2) automatically generate spatial representations that correspond to learned musical actions while listening to music. Participants made one-handed movements to the left or right from a central location in response to visual stimuli while listening to task-irrelevant auditory stimuli, which were scales played on a piano. These task-irrelevant scales were either ascending (compatible with rightward movements) or descending (compatible with leftward movements). Pianists were faster to respond when the scale direction was compatible with the direction of response movement, whereas novices' movements were unaffected by the scale. These results are in agreement with existing research on action-effect coupling in musicians, which draw heavily on common coding theory. In addition, these results show how intricate auditory stimuli (ascending or descending scales) evoke coarse, domain-general spatial representations.

  20. Developing an online professional network for veterinary education: the NOVICE project. (United States)

    Baillie, Sarah; Kinnison, Tierney; Forrest, Neil; Dale, Vicki H M; Ehlers, Jan P; Koch, Michael; Mándoki, Mira; Ciobotaru, Emilia; de Groot, Esther; Boerboom, Tobias B B; van Beukelen, Peter


    An online professional network for veterinarians, veterinary students, veterinary educationalists, and ICT (Information and Communication Technology) educationalists is being developed under the EU (European Union) Lifelong Learning Programme. The network uses Web 2.0, a term used to describe the new, more interactive version of the Internet, and includes tools such as wikis, blogs, and discussion boards. Focus groups conducted with qualified and student veterinarians within the project's five founding countries (The Netherlands, Germany, United Kingdom, Hungary, Romania) demonstrated that online professional communities can be valuable for accessing information and establishing contacts. Online networks have the potential to overcome common challenges to face-to-face communities-such as distance, cost, and timing-but they have their own drawbacks, such as security and professionalism issues. The Network Of Veterinary ICt in Education (NOVICE) was developed using Elgg, an open-source, free social networking platform, after several software options had been considered. NOVICE aims to promote the understanding of Web 2.0, confidence to use social software tools, and participation in an online community. Therefore, the Web site contains help sections, Frequently Asked Questions, and access to support from ICT experts. Five months after the network's launch (and just over one year into the project) 515 members from 28 countries had registered. Further research will include analysis of a core group's activities, which will inform ongoing support for and development of informal, lifelong learning in a veterinary context.