Rozeiu, Alfred M.
In industry, hospital, clinic, laboratory or office, professionals are continually faced with “all size” of problems which can be successfully answered by using investigative scientific methods. The recognition and formulation of an existing problem followed by the desire to seek an answer are the first major steps. Collecting and analyzing data, followed by valid scientific conclusion completes the picture. Professional success means knowing most about something, not something about most. Investigation-research is a particular pattern in weaving, made of organized curiosity, skillful analysis, inventive thinking and professional objectivity. The purpose of the article remains to identify fundamental questions which emerge from clinical observations and practice, to identify and project needed research and to guide the finding of scientific answers.
Ganesan, Kavita; Lloyd, Shane; Sarkar, Vikren
The ability to find highly related clinical concepts is essential for many applications such as for hypothesis generation, query expansion for medical literature search, search results filtering, ICD-10 code filtering and many other applications. While manually constructed medical terminologies such as SNOMED CT can surface certain related concepts, these terminologies are inadequate as they depend on expertise of several subject matter experts making the terminology curation process open to geographic and language bias. In addition, these terminologies also provide no quantifiable evidence on how related the concepts are. In this work, we explore an unsupervised graphical approach to mine related concepts by leveraging the volume within large amounts of clinical notes. Our evaluation shows that we are able to use a data driven approach to discovering highly related concepts for various search terms including medications, symptoms and diseases. PMID:27656096
By Nancy Parrish, Staff Writer One morning in early January, Amar Klar sat down at his computer and found an e-mail with a curious message from a colleague. While reading a bestselling novel, The Marriage Plot by Jeffrey Eugenides, his colleague, a professor at Princeton University, found a description of research on yeast genetics that was surprisingly similar to Klar’s early research. Even the laboratory in the novel was reminiscent of Cold Spring Harbor Laboratory, where Klar had conducted his research.
SCIENCES Life Sciences Research Center...faculty a deeper appreciation for how behavioral science fits in to a larger military context. One of their projects will improve how service members...out of the cloud; they can hit each other. We want them to be inside the cloud, sampling the air. I’m thinking some sort of parachute could help
Zhao, Ying-Yong; Cheng, Xian-long; Lin, Rui-Chao
Lipids are the fundamental components of biological membranes as well as the metabolites of organisms. Lipids play diverse and important roles in biologicals. The lipid imbalance is closely associated with numerous human lifestyle-related diseases, such as atherosclerosis, obesity, diabetes, and Alzheimer's disease. Lipidomics or lipid profiling is a system-based study of all lipids aiming at comprehensive analysis of lipids in the biological system. Lipidomics has been accepted as a lipid-related research tool in lipid biochemistry, clinical biomarker discovery, disease diagnosis, and in understanding disease pathology. Lipidomics will not only provide insights into the specific functions of lipid species in health and disease, but will also identify potential biomarkers for establishing preventive or therapeutic programs for human diseases. This review presents an overview of lipidomics followed by in-depth discussion of its application to the study of human diseases, including extraction methods of lipids, analytical technologies, data analysis, and clinical research in cancer, neuropsychiatric disease, cardiovascular disease, kidney disease, and respiratory disease. We describe the current status of the identification of metabolic biomarkers in different diseases. We also discuss the lipidomics for the future perspectives and their potential problems. The application of lipidomics in clinical studies may provide new insights into lipid profiling and pathophysiological mechanisms.
Bahr, Nathan J; Cohen, Aaron M
Translational research is the process of bringing together basic scientific research and improvements in patient care. This process, by its very nature, requires a wide range of skills and resources, typically not found within any single individual. This project investigates the synergistic features of published researchers at the Oregon Clinical and Translational Research Institute(OCTRI) to see how scientists with different specializations can be brought together to improve translational research.The investigated features were author connectivity and complementarity of research subjects. Author connectivity was measured by taking the Average Path Length (APL) and cluster coefficients  over an OCTRIcoauthor network. A high degree of connectivity, or low APL value, would indicate that a researcher has participated in many collaborations and published many papers with other OCTRI researchers. This would imply that they have some experience we could leverage to build teams for translational research. Subject complementarity was established by using pairs of frequently co-occurring MeSH terms. Those terms were then used to bridge researchers together through indirect Swanson matching  and present evidence of topic synergy, or potential collaborative synergy.Our initial investigation supports the development of a collaborative browsing tool to assist the creation of new translational research teams. Such a tool is being developed at the OCTRI and will include a user-centric evaluation in the near future.
Simmon, Keith E.; Fisher, Mark A.
Sequencing of the 16S rRNA gene (16S) is a reference method for bacterial identification. Its expanded use has led to increased recognition of novel bacterial species. In most clinical laboratories, novel species are infrequently encountered, and their pathogenic potential is often difficult to assess. We reviewed partial 16S sequences from >26,000 clinical isolates, analyzed during February 2006–June 2010, and identified 673 that have <99% sequence identity with valid reference sequences and are thus possibly novel species. Of these 673 isolates, 111 may represent novel genera (<95% identity). Isolates from 95 novel taxa were recovered from multiple patients, indicating possible clinical relevance. Most repeatedly encountered novel taxa belonged to the genera Nocardia (14 novel taxa, 42 isolates) and Actinomyces (12 novel taxa, 52 isolates). This systematic approach for recognition of novel species with potential diagnostic or therapeutic relevance provides a basis for epidemiologic surveys and improvement of sequence databases and may lead to identification of new clinical entities. PMID:22377371
Kaufmann, David; Parry, David; Carlsen, Victoria; Carter, Philip; Parry, Emma; Westbrook, Lucy
Clinical Handover in hospital is a process that can cause a major risk to patients, and be inefficient and time-consuming for staff. Software designed to support such processes needs to be used in a demanding and fast-moving environment. This work formulated Usability Design Requirements for such a handover software system. The requirements have been derived from a usability evaluation at Auckland City Hospital, where the handover was observed in two different environments during a handover improvement process. The requirements were produced using a multi-method, triangulated approach and they may be able to inform the design of systems to support clinical handover. The physical environment and the protocols adopted for handover were changed during this process, with software changes waiting for a larger project. Periods of change in work practice may be particularly favourable times to perform such studies, even if major software changes are not implemented. Staff engagement with the process may also be improved during times of change.
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.
Sessler, Daniel I; Imrey, Peter B
Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation-in addition to errors of chance. Confounding can be statistically controlled to the extent that potential factors are known and accurately measured, but, in practice, bias and unknown confounders usually remain additional potential sources of error, often of unknown magnitude and clinical impact. Causality-the most clinically useful relation between exposure and outcome-can rarely be definitively determined from observational studies because intentional, controlled manipulations of exposures are not involved. In this article, we review several types of observational clinical research: case series, comparative case-control and cohort studies, and hybrid designs in which case-control analyses are performed on selected members of cohorts. We also discuss the analytic issues that arise when groups to be compared in an observational study, such as patients receiving different therapies, are not comparable in other respects.
Wermeling, D P
The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.
Shaner, Sarah E.; Hooker, Paul D.; Nickel, Anne-Marie; Leichtfuss, Amanda R.; Adams, Carissa S.; de la Cerda, Dionisia; She, Yuqi; Gerken, James B.; Pokhrel, Ravi; Ambrose, Nicholas J.; Khaliqi, David; Stahl, Shannon S.; Schuttlefield Christus, Jennifer D.
Electrochemical water oxidation is a major focus of solar energy conversion efforts. A new laboratory experiment has been developed that utilizes real-time, hands-on research to discover catalysts for solar energy conversion. The HARPOON, or Heterogeneous Anodes Rapidly Perused for Oxygen Overpotential Neutralization, experiment allows an array of…
Miettinen, Olli S; Bachmann, Lucas M; Steurer, Johann
Clinical research must be understood to be the foundation of scientific medicine of the clinical type. But the essence of scientific clinical medicine remains a matter of profound confusion, even in clinical academia, and so does the essence of clinical research. The confusion now revolves, principally, around 'clinical epidemiology'. We address clinical research in the meaning of quintessentially 'applied' clinical research, which we take to be the foundation of the scientific knowledge base of clinical medicine, of gnosis (dia-, etio-, pro-) in it. More specifically, we address the essence, priorities, and status quo of this research - and argue that the requisite theory of this is not a matter of 'clinical epidemiology' but of theory of clinical research endogenous to clinical (rather than epidemiological) academia.
Cao, Hui; Markatou, Marianthi; Melton, Genevieve B.; Chiang, Michael F.; Hripcsak, George
This paper applies co-occurrence statistics to discover disease-finding associations in a clinical data warehouse. We used two methods, χ2 statistics and the proportion confidence interval (PCI) method, to measure the dependence of pairs of diseases and findings, and then used heuristic cutoff values for association selection. An intrinsic evaluation showed that 94 percent of disease-finding associations obtained by χ2 statistics and 76.8 percent obtained by the PCI method were true associations. The selected associations were used to construct knowledge bases of disease-finding relations (KB-χ2, KB-PCI). An extrinsic evaluation showed that both KB-χ2 and KB-PCI could assist in eliminating clinically non-informative and redundant findings from problem lists generated by our automated problem list summarization system. PMID:16779011
Cao, Hui; Markatou, Marianthi; Melton, Genevieve B; Chiang, Michael F; Hripcsak, George
This paper applies co-occurrence statistics to discover disease-finding associations in a clinical data warehouse. We used two methods, chi2 statistics and the proportion confidence interval (PCI) method, to measure the dependence of pairs of diseases and findings, and then used heuristic cutoff values for association selection. An intrinsic evaluation showed that 94 percent of disease-finding associations obtained by chi2 statistics and 76.8 percent obtained by the PCI method were true associations. The selected associations were used to construct knowledge bases of disease-finding relations (KB-chi2, KB-PCI). An extrinsic evaluation showed that both KB-chi2 and KB-PCI could assist in eliminating clinically non-informative and redundant findings from problem lists generated by our automated problem list summarization system.
Background We consider the user task of designing clinical trial protocols and propose a method that discovers and outputs the most appropriate eligibility criteria from a potentially huge set of candidates. Each document d in our collection D is a clinical trial protocol which itself contains a set of eligibility criteria. Given a small set of sample documentsD′,|D′|≪|D|, a user has initially identified as relevant e.g., via a user query interface, our scoring method automatically suggests eligibility criteria from D, D ⊃ D', by ranking them according to how appropriate they are to the clinical trial protocol currently being designed. The appropriateness is measured by the degree to which they are consistent with the user-supplied sample documents D'. Method We propose a novel three-step method called LDALR which views documents as a mixture of latent topics. First, we infer the latent topics in the sample documents using Latent Dirichlet Allocation (LDA). Next, we use logistic regression models to compute the probability that a given candidate criterion belongs to a particular topic. Lastly, we score each criterion by computing its expected value, the probability-weighted sum of the topic proportions inferred from the set of sample documents. Intuitively, the greater the probability that a candidate criterion belongs to the topics that are dominant in the samples, the higher its expected value or score. Results Our experiments have shown that LDALR is 8 and 9 times better (resp., for inclusion and exclusion criteria) than randomly choosing from a set of candidates obtained from relevant documents. In user simulation experiments using LDALR, we were able to automatically construct eligibility criteria that are on the average 75% and 70% (resp., for inclusion and exclusion criteria) similar to the correct eligibility criteria. Conclusions We have proposed LDALR, a practical method for discovering and inferring appropriate eligibility criteria in clinical
... Youth NCMHEP NICHD Publications Data Sharing and Other Resources Research The Human Placenta Project Research and Funding Frequently Asked Questions (FAQs) Meetings Related News and Media The National Children's ... & Selected Staff Profiles Multimedia About NICHD Institute ...
Siegel, Gerald M.; Young, Martin A.
Despite the similarity between single-subject research sessions and clinical sessions, single-subject research designs are not intrinsically more appropriate than group designs for clinical research concerning the communication disordered. (Author/CB)
Briggs, R; Robinson, S; O'Neill, D
Despite being the most significant consumers of health care resources and medications worldwide, recent international research has highlighted the under-representation of older participants from clinical trials. This creates problems for physicians as the patients seen in clinical practice are not representative of those on which medical treatments and interventions have been trialled, and we need to consider whether results (both negative and positive) from these trials are applicable to these patients. Our aim was to gauge whether exclusion of older people was prevalent in research proposals submitted to Dublin teaching hospitals. We audited all clinical research proposals submitted to the Research Ethics committee (REC) covering the teaching hospitals attached to Trinity College Dublin (TCD) from July 2008 to July 2011 inclusive, recording exclusion of patients based on an arbitrary upper age limit. Of the 226 relevant trials studied, 31(13.7%) excluded participants based solely on an arbitrary upper age limit. 22 (9.8%) of the relevant trials were submitted by geriatricians, none of which excluded patients based solely on age. Over 50% (12 of 22) trials submitted by neurology/psychiatry excluded patients based on an upper age limit. The mean upper age limit used over all trials as a cut-off was 69.2 years of age. As well as this, the majority of the remaining trials also contained other exclusion criteria, especially those based on cognitive function which further limited participation of older people. While we found that a significant proportion of clinical trials submitted to the TCD REC still excluded patients based arbitrarily on an upper age limit, participation rates of older people seem to be higher in this Irish centre than that seen in international trials. Significant room for improvement still remains however and there needs to be a promotion of greater awareness of the need for developing, testing and licensing medicines so that it mirrors the
Hurtt, G. C.; Einaudi, F.; Moore, B.; Salomonson, V.; Campbell, J.
In 2002, the University of New Hampshire (UNH) and NASA Goddard Space Flight Center (GSFC) started the educational initiative Research &Discover with the goals to: (i) recruit outstanding young scientists into research careers in Earth science and Earth remote sensing (broadly defined), and (ii) support Earth science graduate students enrolled at UNH through a program of collaborative partnerships with GSFC scientists and UNH faculty. To meet these goals, the program consists of a linked set of educational opportunities that begins with a paid summer research internship at UNH for students following their Junior year of college, and is followed by a second paid summer internship at GSFC for students following their Senior year of college. These summer internships are then followed by two-year fellowship opportunities at UNH for graduate studies jointly supervised by UNH faculty and GSFC scientists. After 5 years of implementation, the program has awarded summer research internships to 22 students, and graduate research fellowships to 6 students. These students have produced more than 78 scientific research presentations, 5 undergraduate theses, 2 Masters theses, and 4 peer-reviewed publications. More than 80% of alums are actively pursuing careers in Earth sciences now. In the process, the program has engaged 19 faculty from UNH and 15 scientists from GSFC as advisors/mentors. New collaborations between these scientists have resulted in new joint research proposals, and the development, delivery, and assessment of a new course in Earth System Science at UNH. Research &Discover represents an educational model of collaboration between a national lab and university to create a pipeline of the next generation of Earth system scientists.
Talavera, Juan O; Rivas-Ruiz, Rodolfo
Usually, in clinical practice the maneuver selected is the one that achieves a favorable outcome with a direct percentage of superiority of at least 10 %, or when the number needed to treat is approximately equal to 10. While this percentage difference is practical for estimating the magnitude of an association, we need to differentiate the impact measures (attributable risk, preventable fraction), measures of association (RR, OR, HR), and frequency measures (incidence and prevalence) applicable when the outcome is nominal. And we must identify ways to measure the strength of association and the magnitude of the association when the outcome variable is quantitative. It is not uncommon to interpret the measures of association as if they were impact measures. For example, for a RR of 0.68, it is common to assume a 32 % reduction of the outcome, but we must consider that this is a relative reduction, which comes from relations of 0.4/0.6, 0.04/0.06, or 0.00004/0.00006. However the direct reduction is 20 % (60 % - 40 %), 2 %, and 2 per 100,000, respectively. Therefore, to estimate the impact of a maneuver it is important to have the direct difference and/or NNT.
Smithsonian Institution, Washington, DC. Center for Folklife Programs and Cultural Studies.
This teacher guide and student community research guide unit are intended to help students learn to conduct research in their community and to communicate the results of that research to classmates and others. The unit, which can be used in conjunction with a video, helps students learn about community research, oral history, and folklore…
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.
... What is a clinical trial? Clinical trials are medical research studies in which people volunteer to participate. A ... or treat an eye disease or disorder. Generally, medical research begins in laboratories. After a treatment shows promise ...
Miller, Franklin G
Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.
WARD, TED W.
THE RATIONALE OF A CLINICAL APPROACH TO RESEARCH ON TEACHER BEHAVIOR IS SET FORTH TOGETHER WITH INDICATION OF DIFFICULTIES. IN ONE CLINICAL STUDY, RECORDS OF FOCUSED OBSERVATIONS OF TEACHER BEHAVIOR WERE REVIEWED BY A SPECIALIST IN LEARNING AND A SPECIALIST IN SOCIAL PSYCHOLOGY IN RELATION TO RESEARCH FROM THESE FIELDS. TEACHER DECISIONS PROVED…
In May 2012, a HESI-sponsored expert workshop yielded a proposed research strategy for systematically discovering, characterizing, and annotating fish early life-stage (FELS) adverse outcome pathways (AOPs) as well as prioritizing AOP development in light of current restrictions ...
Ghooi, Ravindra B.; Divekar, Deepa
Aims and Objectives: Sponsors need to pay for management of all serious adverse events suffered by subjects in a clinical trial and to compensate for injuries or deaths related to the trial. This study examines if insurance policies of trials, cover all contingencies that require reimbursement or compensation. Materials and Methods: Insurance policies of trials submitted to Sahyadri Hospitals between January 2013 and December 2013 were studied, with respect to the policy period, the limit of liability, deductibles, and preconditions if any. Results: All the policies studied had some deficiencies, in one respect or the other and none had a provision to pay full compensation if required. Some insurers have put in preconditions that could jeopardize the payment of compensation to subjects. Conclusions: Insurances are complicated documents, and need to be critically examined by the ethics committee before approval of the study documents. PMID:25276622
Fornari, D. J.; Fino, D.; Humphris, S. E.; Fruth, L. L.; Dean, S.
We have developed the "Dive and Discover" web site for use in classrooms and for the general public to provide near real-time, daily access to oceanographic research expeditions, particularly those using deep submergence vehicles operated by Woods Hole Oceanographic Institution. The site was one of five science sites nominated for a 2001 Webby Award, was selected by Scientific American as one of the top five sites in the category of earth and environmental science, and was one of Eisenhower National Clearinghouse's "digital dozen" for science resources. The web site consists of two major components. A series of educational modules provide both general educational information about the oceans and the people that study them, as well as cruise-specific information about the natural systems being studied, the participating scientists, and the data and sample-collecting methodologies and technologies being used. The second component consists of modules that allow access to near real-time updates of the progress of the cruise, images of seafloor features and animals, samples of data being collected and used on board, and general information about life on board. In addition, a Mail Buoy provides e-mail access for students to ask questions of the scientists on board the ship during the course of the expedition. COSI Toledo have a linked Educator's Companion that gives access to COSI project management tips, background information, activities, correlations to national science education standards, assessment tools, and a vast array of resources to assist educators in using the web site. We have worked with teachers and students from all over the United States to test, evaluate, and refine the web site during five cruises in the Pacific and Indian Oceans over the last two years. These cruises focused on various problems associated with mid-ocean ridge volcanism, and the chemical, physical and biological processes associated with seafloor hydrothermal activity. Our intention
Pick, Andrew; Berry, Shelley; Gilbert, Kayleigh; McCaul, James
Since increasing numbers of patients are asked to take part in clinical trials, nurses need to be aware of the principles of valid, informed consent. This article explores consent, which aims to protect the rights, safety and wellbeing of patients. In particular, the history of consent in research and the elements involved in obtaining informed consent from potential participants in research studies are discussed.
Hu, Yiwen; Chen, Jiahui; Hu, Guping; Yu, Jianchen; Zhu, Xun; Lin, Yongcheng; Chen, Shengping; Yuan, Jie
Every year, hundreds of new compounds are discovered from the metabolites of marine organisms. Finding new and useful compounds is one of the crucial drivers for this field of research. Here we describe the statistics of bioactive compounds discovered from marine organisms from 1985 to 2012. This work is based on our database, which contains information on more than 15,000 chemical substances including 4196 bioactive marine natural products. We performed a comprehensive statistical analysis to understand the characteristics of the novel bioactive compounds and detail temporal trends, chemical structures, species distribution, and research progress. We hope this meta-analysis will provide useful information for research into the bioactivity of marine natural products and drug development.
Hu, Yiwen; Chen, Jiahui; Hu, Guping; Yu, Jianchen; Zhu, Xun; Lin, Yongcheng; Chen, Shengping; Yuan, Jie
Every year, hundreds of new compounds are discovered from the metabolites of marine organisms. Finding new and useful compounds is one of the crucial drivers for this field of research. Here we describe the statistics of bioactive compounds discovered from marine organisms from 1985 to 2012. This work is based on our database, which contains information on more than 15,000 chemical substances including 4196 bioactive marine natural products. We performed a comprehensive statistical analysis to understand the characteristics of the novel bioactive compounds and detail temporal trends, chemical structures, species distribution, and research progress. We hope this meta-analysis will provide useful information for research into the bioactivity of marine natural products and drug development. PMID:25574736
Lv, Huanhuan; Jiang, Feng; Guan, Daogang; Lu, Cheng; Guo, Baosheng; Chan, Chileung; Peng, Songlin; Liu, Baoqin; Guo, Wenwei; Zhu, Hailong; Xu, Xuegong; Lu, Aiping; Zhang, Ge
Osteoporosis is a progressive skeletal disorder characterized by low bone mass and increased risk of fracture in later life. The incidence and costs associated with treating osteoporosis cause heavy socio-economic burden. Currently, the diagnosis of osteoporosis mainly depends on bone mineral density and bone turnover markers. However, these indexes are not sensitive and accurate enough to reflect the osteoporosis progression. Metabolomics offers the potential for a holistic approach for clinical diagnoses and treatment, as well as understanding of the pathological mechanism of osteoporosis. In this review, we firstly describe the study subjects of osteoporosis and bio-sample preparation procedures for different analytic purposes, followed by illustrating the biomarkers with potentially predictive, diagnosis and pharmaceutical values when applied in osteoporosis research. Then, we summarize the published metabolic pathways related to osteoporosis. Furthermore, we discuss the importance of chronological data and combination of multi-omics in fully understanding osteoporosis. The application of metabolomics in osteoporosis could provide researchers the opportunity to gain new insight into the metabolic profiling and pathophysiological mechanisms. However, there is still much to be done to validate the potential biomarkers responsible for the progression of osteoporosis and there are still many details needed to be further elucidated. PMID:27918446
Lv, Huanhuan; Jiang, Feng; Guan, Daogang; Lu, Cheng; Guo, Baosheng; Chan, Chileung; Peng, Songlin; Liu, Baoqin; Guo, Wenwei; Zhu, Hailong; Xu, Xuegong; Lu, Aiping; Zhang, Ge
Osteoporosis is a progressive skeletal disorder characterized by low bone mass and increased risk of fracture in later life. The incidence and costs associated with treating osteoporosis cause heavy socio-economic burden. Currently, the diagnosis of osteoporosis mainly depends on bone mineral density and bone turnover markers. However, these indexes are not sensitive and accurate enough to reflect the osteoporosis progression. Metabolomics offers the potential for a holistic approach for clinical diagnoses and treatment, as well as understanding of the pathological mechanism of osteoporosis. In this review, we firstly describe the study subjects of osteoporosis and bio-sample preparation procedures for different analytic purposes, followed by illustrating the biomarkers with potentially predictive, diagnosis and pharmaceutical values when applied in osteoporosis research. Then, we summarize the published metabolic pathways related to osteoporosis. Furthermore, we discuss the importance of chronological data and combination of multi-omics in fully understanding osteoporosis. The application of metabolomics in osteoporosis could provide researchers the opportunity to gain new insight into the metabolic profiling and pathophysiological mechanisms. However, there is still much to be done to validate the potential biomarkers responsible for the progression of osteoporosis and there are still many details needed to be further elucidated.
Clinical research implies advancing current knowledge about health care by continually developing and testing new ideas about diseases, products, procedures, and strategies. Although this trait is inherent in human nature, it needs to be encouraged, nurtured, groomed, and channelized by creating a suitable atmosphere for it, providing the necessary resources, inculcating the necessary conceptual and manual skills, and rewarding the efforts and achievements suitably. Language, logic, statistics, and psychology play an important role in acquiring and developing research capability. To be socially relevant and economically viable, clinical research will need to partner with patients and their doctors in identifying what their goals of health care are, what they value, and what they are willing to "buy" in terms of goods and services. Besides, clinical research will need to bring on one platform the sponsors, the researchers, the patients, the payers, and the regulators to ensure that they do not work at cross purposes, that the cost of developing health care measures is scaled down through innovative approaches such as large simple trials, sequential trials, early marketing conditional on post-marketing surveillance, and so on. All these will be possible if day-to-day practice is slowly and systemically transformed into the largest laboratory of clinical research, which it ought to be, by forming networks of research-oriented practices, and popularizing the use of data collection and analysis tools such as Epi Info which are in the public domain.
Sanderson, Iain C; Obeid, Jihad S; Madathil, Kapil Chalil; Gerken, Katherine; Fryar, Katrina; Rugg, Daniel; Alstad, Colin E; Alexander, Randall; Brady, Kathleen T; Gramopadhye, Anand K; Moskowitz, Jay
Background One mechanism to increase participation in research is to solicit potential research participants’ general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically. Purpose The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants’ interest in current and future research involvement and to provide a foundation for facilitating the research workflow. Methods The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users. Results An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions. Limitations There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials. Conclusions We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents. PMID:23785065
Belyanskaya, Svetlana L; Ding, Yun; Callahan, James F; Lazaar, Aili L; Israel, David I
DNA-encoded chemical library technology was developed with the vision of its becoming a transformational platform for drug discovery. The hope was that a new paradigm for the discovery of low-molecular-weight drugs would be enabled by combining the vast molecular diversity achievable with combinatorial chemistry, the information-encoding attributes of DNA, the power of molecular biology, and a streamlined selection-based discovery process. Here, we describe the discovery and early clinical development of GSK2256294, an inhibitor of soluble epoxide hydrolase (sEH, EPHX2), by using encoded-library technology (ELT). GSK2256294 is an orally bioavailable, potent and selective inhibitor of sEH that has a long half life and produced no serious adverse events in a first-time-in-human clinical study. To our knowledge, GSK2256294 is the first molecule discovered from this technology to enter human clinical testing and represents a realization of the vision that DNA-encoded chemical library technology can efficiently yield molecules with favorable properties that can be readily progressed into high-quality drugs.
Peters, Sanne A E; Groenwold, Rolf H H; Bots, Michiel L
An intermediate variable such as blood pressure is part of the causal pathway of mechanisms to a clinical outcome, e.g. myocardial infarction. An intervention affects a clinical outcome through its effect on that intermediate variable. In studies designed to assess the effects of interventions an intermediate variable may be used as surrogate for clinical outcomes. Such an endpoint is also known as an intermediate endpoint. Intervention studies with intermediate endpoints are commonly performed in medical research to evaluate the effects of an intervention on clinical outcomes. Intervention studies with an intermediate endpoint are conducted in a smaller study population and with a shorter duration of follow-up than studies using clinical outcomes. An intermediate variable is not eligible as an intermediate endpoint when the intervention also affects other biological mechanisms that subsequently affect the clinical endpoint. Due to a smaller sample size and shorter study duration, side effects of intervention are more difficult to evaluate in studies with an intermediate endpoint than in studies with clinical endpoints.
Discover Earth is a NASA-sponsored project for teachers of grades 5-12, designed to: (1) enhance understanding of the Earth as an integrated system; (2) enhance the interdisciplinary approach to science instruction; and (3) provide classroom materials that focus on those goals. Discover Earth is conducted by the Institute for Global Environmental Strategies in collaboration with Dr. Eric Barron, Director, Earth System Science Center, The Pennsylvania State University; and Dr. Robert Hudson, Chair, the Department of Meteorology, University of Maryland at College Park. The enclosed materials: (1) represent only part of the Discover Earth materials; (2) were developed by classroom teachers who are participating in the Discover Earth project; (3) utilize an investigative approach and on-line data; and (4) can be effectively adjusted to classrooms with greater/without technology access. The Discover Earth classroom materials focus on the Earth system and key issues of global climate change including topics such as the greenhouse effect, clouds and Earth's radiation balance, surface hydrology and land cover, and volcanoes and climate change. All the materials developed to date are available on line at (http://www.strategies.org) You are encouraged to submit comments and recommendations about these materials to the Discover Earth project manager, contact information is listed below. You are welcome to duplicate all these materials.
Brown, Ken; Dyas, Jane; Chahal, Prit; Khalil, Yesmean; Riaz, Perween; Cummings-Jones, Joy
Background Usually experts decide on which research is worthwhile, yet it is government policy to involve service users in research. There has been a lack of published research about involving patients from minority ethnic groups and people from deprived areas in setting research agendas. In this study we wanted to hear the voices of patients that are not often heard. Aim To find out the research priorities of people with diabetes from an inner city community and compare these with current expert-led research priorities in diabetes. Design of study A qualitative study using a participatory approach with consumer groups. Setting Primary care within inner city Nottingham, UK. Method Thirty-nine adult patients with diabetes with varying ethnic backgrounds recruited from three general practices. Six focus groups carried out in participants' preferred language, analysed using the constant comparative method. Results Nine main themes equating to research priorities were identified. Within these themes, information and awareness, service delivery and primary prevention of diabetes emerged as the main factors. There were no science-based topics and there was more emphasis on culturally influenced research questions, which differed from recent Department of Health priorities. There were several themes about service delivery, patient self-management and screening and prevention of diabetes that overlapped. Conclusions There is some divergence between expert-led and patient-led agendas in research about diabetes. Patient perspectives have a significant influence on research priorities, and there are likely to be several different patient perspectives. PMID:16536961
Resnik, David B; Ness, Elizabeth
Discussions on the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enroll in a study. These responsibilities are based on duties related to promise-keeping, avoiding harm to one's self or others, beneficence and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process, and should stress the importance of fulfilling study requirements. They should address any impediments to compliance, and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements.
Braus, Judy, Ed.
Ranger Rick's NatureScope is a creative education series dedicated to inspiring in children an understanding and appreciation of the natural world while developing the skills they will need to make responsible decisions about the environment. The topic of this issue is "Discovering Deserts." Contents are organized into the following…
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
Doctors are bound to ensure and improve the quality of their own work. This is a significant part of medical professionalism and lasts one's entire working life. In this regard clinical guidelines provide valuable and helpful information because they give recommendations on prevention, diagnosis, treatment, and aftercare based on current evidence. However, in their medical work potential users widely ignore such guidelines. Hence it is necessary to discover barriers to compliance with the guidelines and, based on the findings, to investigate more effective strategies for implementing the guidelines. Analyses and evaluation can be performed by using health services research. Undesirable developments in doctors' daily routines, associated with negative consequences for healthy and ill people, as well as for the economics of health care, can be detected and improvements can be identified systematically. This branch of research has become ever more important - even necessary. It ist likely that the increasing demand for assessing the needs, costs, structural conditions, and quality of health care will confirm the significance of such evaluation.
Tomasik, Janice Hall; LeCaptain, Dale; Murphy, Sarah; Martin, Mary; Knight, Rachel M.; Harke, Maureen A.; Burke, Ryan; Beck, Kara; Acevedo-Polakovich, I. David
Motivating students in analytical chemistry can be challenging, in part because of the complexity and breadth of topics involved. Some methods that help encourage students and convey real-world relevancy of the material include incorporating environmental issues, research-based lab experiments, and service learning projects. In this paper, we…
Yin, Robert K.; Hackett, Edward J.; Chubin, Daryl E.
National Science Foundation's (NSF's) MSP Program seeks foremost "to improve student outcomes in high-quality mathematics and science by all students, at all pre-K-12 levels". The MSP Program, consisting of a portfolio of funded projects, in part positions itself as a research and development (R&D) program. This study has addressed the need to…
Riegman, P H J; Dinjens, W N M; Oosterhuis, J W
Biobanking nowadays is mostly strongly determined by the specific aims of a research group in charge of the biobank, determining their own standards for the collection and annotation of samples. Often a long period is needed to build up the sample and data collections, especially when long-term follow-up data is required. Such collections need a long-term dedication and proper funding. Neglecting either sample number or annotation can result in insignificant or poor results. However, outcome of translational research does not only depend on the sample quality. In many cases it can also be improved to start the experimental design within a multidisciplinary team composed of clinicians including pathologists, molecular biologists, statisticians, bioinformaticians and tissue resource managers. Such a team, capable of careful evaluation of the numbers needed and which or what part of the samples are to be included, could help in obtaining far better results. Many lines of clinical research could benefit more efficiently from the wealth of information stored in well-preserved disease-oriented tissue sample collections with the proper annotations, when the infrastructure around biobanks and new collection build-up is well organized, standardized and streamlined. Future medical research will refine its scientific questions, demanding even further refinement of corresponding clinical information. In addition, larger sample collections are needed to study for instance multifactorial diseases. Today, the samples are collected for tomorrow, therefore, improvement is needed now in standardization, automated enrichment of annotations from hospital information systems and disease registries, insight in overlapping collections of different forms of tissue banking and cooperation in national and international networks.
Tolstoba, N. D.; Saitgalina, A. K.
Russia's student training program continues to set new, ever more difficult goals for itself every year. Nowadays, it has three main aims: the first is to train well-educated professionals; the second is to encourage students' research activity; and last but not least is to draw youth into the arena of global education. This latter point has recently become a key purpose for just about every university in the country. Thus, the Student Research Laboratory for Optical Engineering (SRLOE) at ITMO University strives to provide career guidance for students and to promote light and photon technologies. The article below explores the targets of the SRLOE, its great impact to development and progress in this field, and the new vision of technical education. Today we take for granted all those modern things which didn't exist a couple of decades ago, and life proves that there is a multitude of undiscovered and unexplored technologies within this field. Students all over the world aspire to new heights.
Discover Earth is a NASA-funded project for teachers of grades 5-12 who want to expand their knowledge of the Earth system, and prepare to become master teachers who promote Earth system science in their own schools, counties, and throughout their state. Participants from the following states are invited to apply: Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, and Washington, DC. Teachers selected for the project participate in a two-week summer workshop conducted at the University of Maryland, College Park; develop classroom-ready materials during the workshop for broad dissemination; conduct a minimum of two peer training activities during the coming school year; and participate in other enrichment/education opportunities as available and desired. Discover Earth is a team effort that utilizes expertise from a range of contributors, and balances science content with hands-on classroom applications.
Damon, Inger K
Monkeypox, a vesiculo-pustular rash illness, was initially discovered to cause human infection in 1970 through the World Health Organization (WHO)-sponsored efforts of the Commission to Certify Smallpox Eradication in Western Africa and the Congo Basin. The virus had been discovered to cause a nonhuman primate rash illness in 1958, and was thus named monkeypox. The causative agents of monkeypox and smallpox diseases both are species of Orthopoxvirus. Orthopoxvirus monkeypox, when it infects humans as an epizootic, produces a similar clinical picture to that of ordinary human smallpox. Since 1970, extensive epidemiology, virology, ecology and public health research has enabled better characterization of monkeypox virus and the associated human disease. This work reviews the progress in this body of research, and reviews studies of this "newly" emerging zoonotic disease.
Cassidy, William A.; Renard, Marc L.
The Campo del Cielo meteorite crater field in Argentina contains at least 20 small meteorite craters, but a recent review of the field data and a remote sensing study suggest that there may be more. The fall occurred ˜4000 years ago into a uniform loessy soil, and the craters are well enough preserved so that some of their parameters of impact can be determined after excavation. The craters were formed by multi-ton fragments of a type IA meteoroid with abundant silicate inclusions. Relative to the horizontal, the angle of infall was ˜9°. Reflecting the low angle of infall, the crater field is elongated with apparent dimensions of 3 × 18.5 km. The largest craters are near the center of this ellipse. This suggests that when the parent meteoroid broke apart, the resulting fragments diverged from the original trajectory in inverse relation to their masses and did not undergo size sorting due to atmospheric deceleration. The major axis of the crater field as we know it extends along N63°E, but the azimuths of infall determined by excavation of Craters 9 and 10 are N83.5°E and N75.5°E, respectively. This suggests that the major axis of the crater field is not yet well determined. The three or four largest craters appear to have been formed by impacts that disrupted the projectiles, scattering fragments around the outsides of the craters and leaving no large masses within them; these are relatively symmetrical in shape. Other craters are elongated features with multi-ton masses preserved within them and no fragmentation products outside. There are two ways in which field research on the Campo del Cielo crater field is found to be useful. (1) Studies exist that have been used to interpret impact craters on planetary surfaces other than the Earth. This occurrence of a swarm of projectiles impacting at known angles and similar velocities into a uniform target material provides an excellent field site at which to test the applicability of those studies. (2) Individual
Grant, J S; Davis, L L; Kinney, M R
The primary goal of nursing research is to develop a scientific knowledge base for practice. Postanesthesia nurses are expected to critique nursing research before applying findings to clinical practice. As consumers of research, postanesthesia nurses must be able to employ critical evaluation skills to judge the merit and relevance of research to their clinical practice. This article presents criteria for critiquing clinical nursing research reports to determine their relevance to practice.
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.
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.
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.
Talavera, Juan O; Rivas-Ruiz, Rodolfo; Bernal-Rosales, Laura Paola
In clinical research it is impossible and inefficient to study all patients with a specific pathology, so it is necessary to study a sample of them. The estimation of the sample size before starting a study guarantees the stability of the results and allows us to foresee the feasibility of the study depending on the availability of patients and cost. The basic structure of sample size estimation is based on the premise that seeks to demonstrate, among other cases, that the observed difference between two or more maneuvers in the subsequent state is real. Initially, it requires knowing the value of the expected difference (δ) and its data variation (standard deviation). These data are usually obtained from previous studies. Then, other components must be considered: a (alpha), percentage of error in the assertion that the difference between means is real, usually 5 %; and β, error rate accepting the claim that the no-difference between the means is real, usually ranging from 15 to 20 %. Finally, these values are substituted into the formula or in an electronic program for estimating sample size. While summary and dispersion measures vary with the type of variable according to the outcome, the basic structure is the same.
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.
Petty, JuLeigh; Heimer, Carol A
The purpose of clinical research is to create the scientific foundation for medical practice. In this way of thinking, the effect on medical practice occurs after the research has been completed. Social studies of science have debunked the standard model of scientific research, observing that changes in practice associated with research occur not just because of the results of research but also because of the practice of research. Drawing on fieldwork in HIV clinics in the US, South Africa,Thailand, and Uganda, we argue that clinical trials shape medical practice by altering the organizations in which both medical treatment and clinical trials take place. Three general processes are central to this transformation: the modification of material environments, the reorganization of bureaucratic relations, and the prioritization of research values. These processes unfold somewhat differently in the clinics of poorer countries than in those of wealthier ones.
Schwenzer, Karen J
The history of ethics in clinical research parallels the history of abuse of human beings. The Nuremberg Code, Declaration of Helsinki, and the Belmont Report laid the foundations for modern research ethics. In the United States, the OHRP and the FDA provide guidelines for the ethical conduct of research. Investigators should be familiar with regulations concerning informed consent, doing research in vulnerable populations, and protection of privacy.
Hayward, Jin Hee
Toll-like receptors (TLRs) belong to a class of pattern recognition receptors that play an important role in host defense against pathogens. TLRs on innate immune cells recognize a wide variety of pathogen-associated molecular patterns (PAMPs) and trigger innate immune responses. Later, it was revealed that the same receptors are also utilized to detect tissue damage to trigger inflammatory responses in the context of non-infectious inflammation. In the nervous system, different members of the TLR family are expressed on glial cells including astrocytes, microglia, oligodendrocytes, and Schwann cells, implicating their putative role in innate/inflammatory responses in the nervous system. In this regard, we have investigated the function of TLRs in neuroinflammation. We discovered that a specific member of the TLR family, namely TLR2, functions as a master sentry receptor to detect neuronal cell death and tissue damage in many different neurological conditions including nerve transection injury, intracerebral hemorrhage, traumatic brain injury, and hippocampal excitotoxicity. In this review, we have summarized our research for the last decade on the role of TLR2 in neuroinflammation in the above neurological disorders. Our data suggest that TLR2 can be an efficient target to regulate unwanted inflammatory response in these neurological conditions. PMID:24963278
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 guidelines for researchers to help improve the quality of APS research; and b) prioritizing the ideas for a well-designed multicenter clinical trial and discussing the pragmatics of getting such a trial done. Following a systematic working algorithm, the Task Force identified five major issues that impede APS clinical research and the ability to develop evidence-based recommendations for the management of aPL-positive patients: (1) aPL detection has been based on partially or non-standardized tests, and clinical (and basic) APS research studies have included patients with heterogeneous aPL profiles with different clinical event risks; (2) clinical (and basic) APS research studies have included a heterogeneous group of patients with different aPL-related manifestations (some controversial); (3) thrombosis and/or pregnancy risk stratification and quantification are rarely incorporated in APS clinical research; (4) most APS clinical studies include patients with single positive aPL results and/or low-titer aPL ELISA results; furthermore, study designs are mostly retrospective and not population based, with limited number of prospective and/or controlled population studies; and (5) lack of the understanding the particular mechanisms of aPL-mediated clinical events limits the optimal clinical study design. The Task Force recommended that there is an urgent need for a truly international collaborative approach to design and conduct well-designed prospective large-scale multi-center clinical trials of patients with persistent and clinically significant aPL profiles. An international collaborative meeting to formulate a good research question using 'FINER' (Feasible; Interesting
Preshaw, Philip M
As periodontal researchers and clinicians, we are challenged every day to make decisions relating to the clinical management of our patients and about how best to conduct clinical periodontal research. This volume of Periodontology 2000 addresses some of the critical issues in contemporary clinical periodontics and periodontal research that are of direct relevance to clinicians, researchers, teachers and students. The 11 review articles in this volume of Periodontology 2000 focus on aspects of periodontal research methodology and clinical periodontology. In terms of research methodology, the articles aim to inform the reader on topics relating to randomized controlled trials in periodontal research, evidence-based dentistry, calibration of clinical examiners and statistics relevant to periodontal research. The clinical periodontology articles address issues relating to decisions on retaining periodontally compromised teeth or replacing them with implants, periodontal management in the patient with osteoporosis, surgical approaches for root coverage and the emerging science of advanced regenerative technologies, including the use of stem cells, for periodontal regeneration. It is hoped that these critical reviews will address many of the dilemmas that confront us on a regular basis and provide practical guidance to those engaged in both clinical periodontology and clinical periodontal research.
ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT NUMBER Cleveland Clinic Foundation 9500 Euclid Ave Cleveland, Ohio 44195 9. SPONSORING / MONITORING AGENCY...Foundation. There are no plans to add another site. Investigational Site Investigators Cleveland Clinic Foundation 9500 Euclid Avenue, Cleveland...PI: Ela Plow PhD PT 9500 Euclid Ave CLEVELAND, OHIO 44106 CONTACT PERSON: Ela Plow PhD PT PHONE: (216)-445-4589 FAX: (216) 445-6083 E-MAIL
Writing a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. The purpose of this article is to summarize the most important steps and necessary guidelines for producing a standard research protocol. Academic and administrative success of any project is usually determined by acquiring a grant for the related field of research. Hence, the quality of a protocol is primarily required to achieve success in this scientific competition. PMID:28050522
Higgins, Isabel; Parker, Vicki; Keatinge, Diana; Giles, Michelle; Winskill, Rhonda; Guest, Eileen; Kepreotes, Elizabeth; Phelan, Caroline
The need for research in practice is well documented within nursing and other health care disciplines. This acceptance is predicated on the belief that clinically applied research will inform and improve practice and health service delivery resulting in better outcomes for consumers and their families. Nurses, however, find doing clinical research challenging. This paper describes nurses' experiences of doing clinical research. The main challenges of doing clinical research arise from a culture that prioritises practice where nursing work is core business and there is the need to address immediate and short term goals. There are also problems associated with the use of research language amongst clinical nurses and ambiguity in relation to research role expectations. Lack of support and resources for doing research along with keeping up the momentum for a research project also pose significant challenges. The benefits of doing clinical nursing research include experiential learning that has the potential to lead to practice change and improved patient outcomes that are evidence based.
Accardo, Pasquale J., Ed.; Magnusen, Christy, Ed.; Capute, Arnold J., Ed.
This text examines the characteristics that define autism: impairments in communication; abnormal social development; and clinically significant odd behaviors. Specific chapters include: (1) Neural Mechanisms in Autism (Andrew W. Zimmerman and Barry Gordon); (2) Epidemiology of Autism and Other Pervasive Developmental Disorders: Current…
... Advocacy Groups About Us What is the RDCRN? Data Management And Coordinating Center (DMCC) Contact Us Working together ... up of 21 research groups (consortia) and a Data Management and Coordinating Center that are working together to ...
Nanivadekar, Arun S.
Research ought to be inculcated as an attitude during the formative years of every health-care professional. The core elements of research are curiosity, observation, reasoning, and experimentation. These suggestions are supported with suitable examples. Medical advisers in the pharmaceutical industry are in a unique position to act as facilitators of such a process. The tools they can use are also suggested. PMID:28194336
Clinical research participants are often not reflective of real-world patients due to overly restrictive eligibility criteria. Meanwhile, unselected participants introduce confounding factors and reduce research efficiency. Biomedical informatics, especially Big Data increasingly made available from electronic health records, offers promising aids to optimize research participant selection through data-driven transparency.
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
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.
Makarushka, Julia L.; Lally, John J.
Recent discussion of the ethical problems of biomedical human experimentation has drawn attention to the responsibility of the medical schools for training new clinical investigators and for safeguarding the rights and welfare of the subjects of clinical research conducted in the medical schools and their affiliated hospitals. (Author)
Becker, Karen A.
Describes a program of Library Research Clinics developed at Northern Illinois University to teach bibliographic instruction (BI) to one or two students at a time as an alternative to teaching BI in large first-year English classes. Implementation of the clinics with educationally disadvantaged students and with honor students is reviewed.…
Rusinová, Katerĭna; Pochard, Frédéric; Kentish-Barnes, Nancy; Chaize, Marine; Azoulay, Elie
Qualitative research and its methods stem from the social sciences and can be used to describe and interpret complex phenomena that involve individuals' views, beliefs, preferences, and subjective responses to places and people. Thus, qualitative research explores the many subjective factors that may influence patient outcomes, staff well-being, and healthcare quality, yet fail to lend themselves to the hypothesis-testing approach that characterizes quantitative research. Qualitative research is valuable in the intensive care unit to explore organizational and cultural issues and to gain insight into social interactions, healthcare delivery processes, and communication. Qualitative research generates explanatory models and theories, which can then serve to devise interventions, whose efficacy can be studied quantitatively. Thus, qualitative research works synergistically with quantitative research, providing new impetus to the research process and a new dimension to research findings. Qualitative research starts with conceptualizing the research question, choosing the appropriate qualitative strategy, and designing the study; rigorous methods specifically designed for qualitative research are then used to conduct the study, analyze the data, and verify the findings. The researcher is the data-collecting instrument, and the data are the participants' words and behaviors. Data coding methods are used to describe experiences, discover themes, and build theories. In this review, we outline the rationale and methods for conducting qualitative research to inform critical care issues. We provide an overview of available qualitative methods and explain how they can work in close synergy with quantitative methods. To illustrate the effectiveness of combining different research methods, we will refer to recent qualitative studies conducted in the intensive care unit.
Ring, Arne; Schall, Robert; Loke, Yoon K; Day, Simon
Research in clinical pharmacology covers a wide range of experiments, trials and investigations: clinical trials, systematic reviews and meta-analyses of drug usage after market approval, the investigation of pharmacokinetic-pharmacodynamic relationships, the search for mechanisms of action or for potential signals for efficacy and safety using biomarkers. Often these investigations are exploratory in nature, which has implications for the way the data should be analysed and presented. Here we summarize some of the statistical issues that are of particular importance in clinical pharmacology research.
The National Cancer Institute (NCI), through the Office of Cancer Clinical Proteomics Research (OCCPR), has signed two Memorandums of Understanding (MOUs) in the sharing of proteomics reagents and protocols
Hepler, Charles D.
Research needs for pharmacy administration and clinical pharmacy include study of the relationship of pharmacists and society, management methods for providing health care services, pharmacist training and socialization, competence evaluation, formative and summative research on drug use control, and organizational decision making. (MSE)
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.
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.
Tulloch, J F; Antczak-Bouckoms, A A; Tuncay, O C
The orthodontic journals should provide valid and reliable information that helps clinicians make appropriate decisions about patient care. The nature of the published literature has not been categorized. The American Journal of Orthodontics and Dentofacial Orthopedics (formerly the American Journal of Orthodontics) was reviewed for the years 1976, 1981, and 1986, to determine the frequency of clinical articles, the topics reported, the study designs used to obtain information, the senior author affiliation, and the major funding sources. This review demonstrates that more than half the articles in this Journal report data on patients, with the majority focusing on the evaluation or description of therapeutic interventions. Academic institutions contribute the majority of the clinical research, although only a few student theses are published. The major support for this work continues to be from departmental resources with little external funding. Despite the introduction of powerful research designs such as randomized clinical trials, these methods have not been widely adopted for orthodontic clinical research. The case report (study containing fewer than 10 patients with no control nor comparison group) continues to be the most frequently published format. Clinicians should become aware of the inherent weakness in the research designs generally used and recognize the limited information that can be obtained from such methods. Support for this research needs to be greatly expanded if the more powerful type of study required to provide valid and reliable clinical information is to be continued.
... A Clinical Study Find You How does clinical research work? Visit our website and click on New National Institutes of Health (NIH) Clinical Research Awareness Website The NIH Clinical Center has joined ...
Statistical analysis is one of the foundations of evidence-based clinical practice, a key in conducting new clinical research and in evaluating and applying prior research. In this paper, we review the choice of statistical procedures, analyses of the associations among variables and techniques used when the clinical processes being examined are still in process. We discuss methods for building predictive models in clinical situations, and ways to assess the stability of these models and other quantitative conclusions. Techniques for comparing independent events are distinguished from those used with events in a causal chain or otherwise linked. Attention then turns to study design, to the determination of the sample size needed to make a given comparison, and to statistically negative studies.
Yu, Liansheng; Hisatsune, Junzo; Hayashi, Ikue; Tatsukawa, Nobuyuki; Sato’o, Yusuke; Mizumachi, Emiri; Kato, Fuminori; Hirakawa, Hideki; Pier, Gerald B.
ABSTRACT Staphylococcus aureus TF2758 is a clinical isolate from an atheroma and a super-biofilm-elaborating/polysaccharide intercellular adhesin (PIA)/poly-N-acetylglucosamine (PNAG)-overproducing strain (L. Shrestha et al., Microbiol Immunol 60:148–159, 2016, https://doi.org/10.1111/1348-0421.12359). A microarray analysis and DNA genome sequencing were performed to identify the mechanism underlying biofilm overproduction by TF2758. We found high transcriptional expression levels of a 7-gene cluster (satf2580 to satf2586) and the ica operon in TF2758. Within the 7-gene cluster, a putative transcriptional regulator gene designated rob had a nonsense mutation that caused the truncation of the protein. The complementation of TF2758 with rob from FK300, an rsbU-repaired derivative of S. aureus strain NCTC8325-4, significantly decreased biofilm elaboration, suggesting a role for rob in this process. The deletion of rob in non-biofilm-producing FK300 significantly increased biofilm elaboration and PIA/PNAG production. In the search for a gene(s) in the 7-gene cluster for biofilm elaboration controlled by rob, we identified open reading frame (ORF) SAOUHSC_2898 (satf2584). Our results suggest that ORF SAOUHSC_2898 (satf2584) and icaADBC are required for enhanced biofilm elaboration and PIA/PNAG production in the rob deletion mutant. Rob bound to a palindromic sequence within its own promoter region. Furthermore, Rob recognized the TATTT motif within the icaR-icaA intergenic region and bound to a 25-bp DNA stretch containing this motif, which is a critically important short sequence regulating biofilm elaboration in S. aureus. Our results strongly suggest that Rob is a long-sought repressor that recognizes and binds to the TATTT motif and is an important regulator of biofilm elaboration through its control of SAOUHSC_2898 (SATF2584) and Ica protein expression in S. aureus. PMID:28143981
... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... medical specialties within the general areas of biomedical, behavioral and clinical science research....
... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... medical specialties within the general areas of biomedical, behavioral and clinical science research....
... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Biomedical Laboratory Research and Development and Clinical Science Research and Development Services... areas of biomedical, behavioral and clinical science research. The panel meetings will be open to...
... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... medical specialties within the general areas of biomedical, behavioral and clinical science research....
... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... specialties within the general areas of biomedical, behavioral, and clinical science research. The...
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.
Talavera, Juan O; Wacher-Rodarte, Niels H; Rivas-Ruiz, Rodolfo
The need to solve a clinical problem leads us to establish a starting point to address (risk, prognosis or treatment studies), all these cases seek to attribute causality. Clinical reasoning described in the book Clinical Epidemiology. The architecture of clinical research, offers a simple guide to understanding this phenomenon. And proposes three basic components: baseline, maneuver and outcome. In this model, different systematic errors (bias) are described, which may be favored by omitting characteristics of the three basic components. Thus, omissions in the baseline characteristics cause an improper assembly of the population and susceptibility bias, omissions in the application or evaluation of the maneuver provoke performance bias, and omissions in the assessment of out-come cause detection bias and transfer bias. Importantly, if this way of thinking facilitates understanding of the causal phenomenon, the appropriateness of the variables to be selected in the studies to which attribute or not causality, require additional arguments for evaluate clinical relevance.
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
Parker, Richard I.; Hagan-Burke, Shanna
The movement toward evidence-based treatments, interventions, or practices pressures single case research (SCR) to use statistical summaries which have broad credibility. These summaries also need to be easily understood and useful in schools and clinics. To date the effect size families, "proportion of variance"…
Strickland, Bonnie R.
Since the development of the Lubin Depression Adjective Check Lists (DACL) in 1965, researchers have used this instrument in many empirical and clinical studies. Scores on the DACL have correlated with other measures of depression and have also been related to personal characteristics of depressed individuals. The DACL has been used in studies to…
Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe
In clinical research that takes place in health-care areas, most of the studies are performed with human beings as research subjects. The main objectives of these studies are to know the characteristics of one or more groups, the behavior of human diseases, the etiology or causes of diseases, to identify the best diagnostic tools, or to establish the best treatment for a condition or disease in particular. Additionally, some studies are classified as basic bio-medical research; in these investigations, the subjects of study are laboratory animals, tissues, cells, or molecules. In general terms, the objectives of these studies are to understand the physiology, pathogenesis, or biological mechanisms that could explain functions or alterations in one or more systems or body organs. This article will only address clinical research designs.
Fetal cardiac interventions for congenital heart diseases may alleviate heart dysfunction, prevent them evolving into hypoplastic left heart syndrome, achieve biventricular outcome and improve fetal survival. Candidates for clinical fetal cardiac interventions are now restricted to cases of critical aortic valve stenosis with evolving hypoplastic left heart syndrome, pulmonary atresia with an intact ventricular septum and evolving hypoplastic right heart syndrome, and hypoplastic left heart syndrome with an intact or highly restrictive atrial septum as well as fetal heart block. The therapeutic options are advocated as prenatal aortic valvuloplasty, pulmonary valvuloplasty, creation of interatrial communication and fetal cardiac pacing. Experimental research on fetal cardiac intervention involves technical modifications of catheter-based cardiac clinical interventions and open fetal cardiac bypass that cannot be applied in human fetuses for the time being. Clinical fetal cardiac interventions are plausible for midgestation fetuses with the above-mentioned congenital heart defects. The technical success, biventricular outcome and fetal survival are continuously being improved in the conditions of the sophisticated multidisciplinary team, equipment, techniques and postnatal care. Experimental research is laying the foundations and may open new fields for catheter-based clinical techniques. In the present article, the clinical therapeutic options and experimental fetal cardiac interventions are described. PMID:27279868
Jacobson, Ann F; Warner, Andrea M; Fleming, Eileen; Schmidt, Bruce
Clinical research is necessary for developing nursing's body of knowledge and improving the quality of gastroenterology nursing care. The support and participation of nursing staff are crucial to conducting interventional research. Identification of characteristics of nurses and their work settings that facilitate or impede participation in research is needed. The purpose of this descriptive correlational study was to examine the effect of personal and professional characteristics and attitudes about nursing research on staff nurses' participation in a clinical nursing research project. A questionnaire measuring nurses' attitudes, perceptions of availability of support, and research use was distributed to staff nurses working on an endoscopy lab and two same-day surgery units where a nursing research study had recently been conducted. Investigator-developed items measured nurses' attitudes about the utility and feasibility of the interventions tested in the original study. A total of 36 usable questionnaires comprised the sample. Factor analysis of the two questionnaires resulted in three-factor (Importance of Research, Interest in Research, and Environment Support of Research) and two-factor (Value of Cognitive-Behavioral Interventions [CBIs] and Participation in Study) solutions, respectively. There were no statistically significant differences in mean scores for the five factors between nurses who did (n = 19) and those who did not (n = 17) participate in the original study. The Participation in Research Factor was significantly negatively correlated with years in nursing (r = -.336, p < .05) and positively correlated with the importance of research factor (r = .501, p < .01). Importance of research was negatively correlated with years in nursing (r = -.435, p < .01) and positively correlated with value of CBI (r = .439, p < .01) and participation in study (r = .501, p < .01). Findings from the study will contribute to the body of knowledge about factors that
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…
McMahon, Jenny; McGannon, Kerry R.
This paper centres on one researcher's narrative inquiry of embodied experience. The purpose of this paper is to initiate and extend dialogue which highlights potential possibilities and limitations for those researchers and participants who choose to engage with the narrative inquiry approach. Of special concern are four points or evocations that…
Sim, Ida; Tu, Samson W.; Carini, Simona; Lehmann, Harold P.; Pollock, Brad H.; Peleg, Mor; Wittkowski, Knut M.
To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes — the science of clinical research — are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe’s modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study’s scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research. PMID:24239612
Du, Guangyuan; Zhu, Jiang
Keloid refers to the damaged skin due to excessive fibroblast proliferation. Ear is one predilection site. The pathogenesis of ear keloid is not very clear, and the treatment is also varied. Surgery, postoperative radiotherapy and laser treatment, steroid hormones, pressure therapy are the basic treatment methods. Integrated application of a variety of treatments, classification research and new materials using revealed the prospect for the treatment of the disease. This thesis reviews literature about ear keloid in recent 10 years, and introduces this disease and clinical research progress.
Kee, Ashley Nichole
A set of standard operating procedures (SOPs) provides a clinical research department with clear roles, responsibilities, and processes to ensure compliance, accuracy, and timeliness of data. SOPs also serve as a standardized training program for new employees. A practice may have an employee that can assist in the development of SOPs. There are also consultants that specialize in working with a practice to develop and write practice-specific SOPs. Making SOPs a priority will save a practice time and money in the long run and make the research practice more attractive to corporate study sponsors.
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.
Legout, Laurence; Senneville, Eric
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. PMID:24288493
England, J D; Gronseth, G S; Franklin, G; Miller, R G; Asbury, A K; Carter, G T; Cohen, J A; Fisher, M A; Howard, J F; Kinsella, L J; Latov, N; Lewis, R A; Low, P A; Sumner, A J
The objective of this report was to develop a case definition of "distal symmetrical polyneuropathy" to standardize and facilitate clinical research and epidemiological studies. A formalized consensus process was employed to reach agreement after a systematic review and classification of evidence from the literature. The literature indicates that symptoms alone have relatively poor diagnostic accuracy in predicting the presence of polyneuropathy; signs are better predictors of polyneuropathy than symptoms; and single abnormalities on examination are less sensitive than multiple abnormalities in predicting the presence of polyneuropathy. The combination of neuropathic symptoms, signs, and electrodiagnostic findings provides the most accurate diagnosis of distal symmetrical polyneuropathy. A set of case definitions was rank ordered by likelihood of disease. The highest likelihood of polyneuropathy (useful for clinical trials) occurs with a combination of multiple symptoms, multiple signs, and abnormal electrodiagnostic studies. A modest likelihood of polyneuropathy (useful for field or epidemiological studies) occurs with a combination of multiple symptoms and multiple signs when the results of electrodiagnostic studies are not available. A lower likelihood of polyneuropathy occurs when electrodiagnostic studies and signs are discordant. For research purposes, the best approach for defining distal symmetrical polyneuropathy is a set of case definitions rank ordered by estimated likelihood of disease. The inclusion of this formalized case definition in clinical and epidemiological research studies will ensure greater consistency of case selection.
Three undergraduate students, from Leiden University in the Netherlands, have discovered an extrasolar planet. The extraordinary find, which turned up during their research project, is about five times as massive as Jupiter. This is also the first planet discovered orbiting a fast-rotating hot star. Omega Centauri ESO PR Photo 45a/08 A planet around a hot star The students were testing a method of investigating the light fluctuations of thousands of stars in the OGLE database in an automated way. The brightness of one of the stars was found to decrease for two hours every 2.5 days by about one percent. Follow-up observations, taken with ESO's Very Large Telescope in Chile, confirmed that this phenomenon is caused by a planet passing in front of the star, blocking part of the starlight at regular intervals. According to Ignas Snellen, supervisor of the research project, the discovery was a complete surprise. "The project was actually meant to teach the students how to develop search algorithms. But they did so well that there was time to test their algorithm on a so far unexplored database. At some point they came into my office and showed me this light curve. I was completely taken aback!" The students, Meta de Hoon, Remco van der Burg, and Francis Vuijsje, are very enthusiastic. "It is exciting not just to find a planet, but to find one as unusual as this one; it turns out to be the first planet discovered around a fast rotating star, and it's also the hottest star found with a planet," says Meta. "The computer needed more than a thousand hours to do all the calculations," continues Remco. The planet is given the prosaic name OGLE2-TR-L9b. "But amongst ourselves we call it ReMeFra-1, after Remco, Meta, and myself," says Francis. The planet was discovered by looking at the brightness variations of about 15 700 stars, which had been observed by the OGLE survey once or twice per night for about four years between 1997 and 2000. Because the data had been made public
Talavera, Juan O
The endeavor of clinical research to study a group of patients is to make a diagnosis, estimate the prognosis and prove a treatment. For this purpose is used the scientific method: 1) the architectural arrangement, which can be divided into cause-effect and the process of research; 2) the methodological approach, which includes controlled clinical trials, cohorts, case control, and cross-sectional designs; 3) the goal-oriented approach, in which studies on diagnostic tests, prognosis, treatment and risk or causal factors are grouped. The designs mentioned above are considered primary studies; it means that the information was obtained directly from the subjects studied. There is a second category of studies, which uses information obtained from the primary studies. This is the reason why they are considered as secondary or integrative studies.
Michel, Christiane Röckl; Standke, Gesche; Naef, Reto
The Novartis School Lab (http://www.novartis.ch/schullabor) is an institution with an old tradition. The School Lab reaches about 5000 students through internal courses and an additional 5000 children at public science events where they can enjoy hands-on science in disciplines of biomedical research. The subjects range from chemistry, physics, molecular biology and genetics to toxicology and medical topics. The Novartis School Lab offers a variety of activities for youngsters aged 10-20 ranging from lab courses for school classes, continuing education for teachers and development of teaching kits, support for individual research projects to outreach for public science events. Innovation and adaptation to changes of current needs are essential aspects for the Novartis School Lab. Ongoing activities to shape the Novartis Biomedical Learning Lab include design of new teaching experiments, exploration into additional disciplines of biomedical science and the creation of a fascinating School Lab of the future.
Ban, Thomas A
Neuropsychopharmacology is dedicated to the study of the pathophysiology and treatment of mental pathology with the employment of centrally acting drugs. In neuropsychopharmacological research the clinical effects of a psychotropic drug are linked to the effects of the substance on brain structures involved in its mode of action. It is assumed, that knowledge about the mode of action of a selectively effective psychotropic drug will provide clues about the pathophysiology of the illness, and conversely, that knowledge about the pathophysiology of an illness, will provide clues for developing clinically more effective psychotropic drugs. Since the currently employed clinical methodology for the demonstration of therapeutic efficacy links the mode of action of psychotropic drugs to pharmacologically heterogeneous populations, neuropsychopharmacological research does not provide the necessary feedback for developing more effective drugs. To resolve the pharmacological heterogeneity within currently used diagnoses, attempts were made to split syndrome-based psychiatric diagnoses into discrete neurobiological deficits, and to replace traditional psychiatric nosology by a genetic psychiatric nosology. Yet, to date, there is no alternative methodology to psychopathology-based psychiatric nosology for classifying mental pathology in a clinically relevant manner. As we are moving from the "neurotransmitter era" to a "genetic era" in neuropsychopharmacology, the need for identifying pharmacologically homogenous populations is becoming imminent. All primary targets of psychotropic drugs in the brain are encoded by genes which are identified, and any nosologic entity or psychiatric syndrome that corresponds with a treatment responsive population is a candidate for the generation of genetic hypotheses relevant to mental illness. Recognition that progress in neuropsychopharmacology, and molecular genetic research, depends on the speed clinical research can resolve the
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.
Ramsier, C.; Norton, D.
Research at the Ohio State University and the USDA-ARS National Soil Erosion Research Lab at Purdue University has uncovered some viable new reasons for using FGD-gypsum as a regular part of production agriculture. Work has centered on FGD gypsum or calcium sulfite and to a much lesser extent on fly ash. Researchers have found three agronomically valuable functions of these materials. First, and most obvious, is the fertilizer value of these materials. Gypsum applications to the soil surface provide the rainfall with an alternative source of electrolyte which prevents soil crushing, thus keeping the soil open and permeable to rainwater and air. Gypsum is more effective than liming materials atremediation of sub-soil acidity by detoxifying the excess exchangeable aluminium, which causes low pH. One proven way to sequester carbon is to fix it as organic matter in soil. 90% of the carbon in roots is converted to soil organic matter, whereas 90% of surface residue is oxide and the carbon returned to the atmosphere. Therefore, more carbon is sequestered by increasing root growth. Improved soil water management also reduces nitrous oxide emissions from soils. The utility's world is improved since the highest quality and lowest cost material is generated by an emission control scrubber as FGD-gypsum. There are more than 175 million crop acres in the US alone. Each acre would require 0.5 ton per year to prevent surface sealing. This means that the potential for FGD-gypsum use is more than 80 million tons per year. 4 photos.
By Andrea Frydl, Contributing Writer In a recent article published in the Journal of Virology, Tianlei Ying, Ph.D., Dimiter Dimitrov, Ph.D., and their colleagues in the Laboratory of Experimental Immunology (LEI), Cancer and Inflammation Program, NCI Center for Cancer Research, reported the identification of three human monoclonal antibodies (m336, m337, and m338) that target the part of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) that is responsible for binding to its receptor. These antibodies are exceptionally potent inhibitors of MERS-CoV infection and also provide a basis for creating a future MERS-CoV vaccine.
Chung, Kevin C.
Clinical research designed to enhance the quality of healthcare has always received a great deal of national attention. Outcomes studies, clinical trials, and evidence-based research are key components of clinical research that have advanced the field of hand surgery. The purpose of the Weiland Award is to encourage innovations and progress in clinical research in hand surgery for the betterment of patients and to promote hand surgery’s visibility in American medicine. This article will highlight my efforts in clinical research through three specific research themes: (1) outcomes research, (2) economic analysis, and (3) evidence-based research and quality assessment in healthcare. PMID:20117312
Bhargava, Deepa; Al-Lawatia, Zainab; Al-Abri, Rashid; Bhargava, Kamlesh
Objectives: A perception exists that clinicians in Oman are reluctant to adopt evidence-based practice (EBP). This pilot study was undertaken to study the feasibility of using EBP pathways at the point of care in otorhinolaryngology head and neck surgery. The ultimate aim was to facilitate EBP with the probability of developing a new system for implementing research findings/translational research at the clinical point of care. Methods: A cross-sectional prospective questionnaire pilot survey of clinicians at Sultan Qaboos University Hospital (SQUH), Oman, a tertiary care medical centre, was undertaken. Respondents included 135 physicians and surgeons with between 3 months and 25 years of clinical experience and included personnel ranging from interns to senior consultants, in areas ranging from primary care to specialist care. Results: Of those polled, 90% (95% confidence interval (CI) 85–95%) either strongly agreed or agreed that evidence-based practice protocols (EBPP) could help in decision making. A total of 87.4% of participants (95% CI 81.8–93%) either strongly agreed or agreed that EBPPs can improve clinical outcomes; 91.8% of participants (95% CI 87.2–96.4%) would use and apply EBPP in day-to-day care if they were available at the point of care and embedded in the hospital information system. Conclusions: The perception that clinicians at SQUH are reluctant to adopt EBP is incorrect. The introduction of EBP pathways is very feasible at the primary care level. Institutional support for embedding EBP in hospital information systems is needed as well as further outcome research to assess the improvement in quality of care. PMID:22548137
Vray, Muriel; Simon, François; Bompart, François
On the basis of a review of current clinical research conditions in developing countries, guidelines have been formulated to ensure scientific validity as well as adherence to universal ethical principles. The main recommendation is that projects should be reviewed by two Institutional Review Boards, one in the country where the Study Sponsor is based, and another in the country where the study is being carried out. In addition, an independent Data Safety Monitoring Board should be set up and systems established to ensure the effective reporting of Serious Adverse Events and to specify the Sponsor's obligations after the end of the Study.
Dietrich, Christoph F; Sharma, Malay; Gibson, Robert N; Schreiber-Dietrich, Dagmar; Jenssen, Christian
The fortuitously discovered liver lesion is a common problem. Consensus might be expected in terms of its work-up, and yet there is none. This stems in part from the fact that there is no preventive campaign involving the early detection of liver tumors other than for patients with known liver cirrhosis and oncological patients. The work-up (detection and differential diagnosis) of liver tumors comprises theoretical considerations, history, physical examination, laboratory tests, standard ultrasound, Doppler ultrasound techniques, contrast-enhanced ultrasound (CEUS), computed tomography and magnetic resonance imaging, as well as image-guided biopsy. CEUS techniques have proved to be the most pertinent method; these techniques became part of the clinical routine about 10 years ago in Europe and Asia and are used for a variety of indications in daily clinical practice. CEUS is in many cases the first and also decisive technical intervention for detecting and characterizing liver tumors. This development is reflected in many CEUS guidelines, e.g., in the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) guidelines 2004, 2008 and 2012 as well as the recently published World Federation for Ultrasound in Medicine and Biology-EFSUMB guidelines 2012. This article sets out considerations for making a structured work-up of incidental liver tumors feasible. PMID:23745019
Khurshid, Anjum; Nauman, Elizabeth; Carton, Tom; Horswell, Ron
The state of Louisiana, like the nation as a whole, is facing the salient challenge of improving population health and efficiency of healthcare delivery. Research to inform innovations in healthcare will best enhance this effort if it is timely, efficient, and patient-centered. The Louisiana Clinical Data Research Network (LACDRN) will increase the capacity to conduct robust comparative effectiveness research by building a health information technology infrastructure that provides access to comprehensive clinical data for more than 1 million patients statewide. To ensure that network-based research best serves its end-users, the project will actively engage patients and providers as key informants and decision-makers in the implementation of LACDRN. The network's patient-centered research agenda will prioritize patients’ and clinicians’ needs and aim to support evidence-based decisions on the healthcare they receive and provide, to optimize patient outcomes and quality of life. PMID:24821735
Brown, Simon G A
Anaphylaxis is a severe immediate-type hypersensitivity reaction characterized by life-threatening upper airway obstruction bronchospasm and hypotension. Although many episodes are easy to diagnose by the combination of characteristic skin features with other organ effects, this is not always the case and a workable clinical definition of anaphylaxis and useful biomarkers of the condition have been elusive. A recently proposed consensus definition is ready for prospective validation. The cornerstones of management are the supine position, adrenaline and volume resuscitation. An intramuscular dose of adrenaline is generally recommended to initiate treatment. If additional adrenaline is required, then a controlled intravenous infusion might be more efficacious and safer than intravenous bolus administration. Additional bronchodilator treatment with continuous salbutamol and corticosteroids are used for severe and/or refractory bronchospasm. Aggressive volume resuscitation, selective vasopressors, atropine (for bradycardia), inotropes that bypass the beta-adrenoreceptor and bedside echocardiographic assessment should be considered for hypotension that is refractory to treatment. Management guidelines continue to be opinion- and consensus-based, with retrospective studies accounting for the vast majority of clinical research papers on the topic. The clinical spectrum of anaphylaxis including major disease subgroups requires clarification, and validated scoring systems and outcome measures are needed to enable good-quality prospective observational studies and randomized controlled trials. A systematic approach with multicentre collaboration is required to improve our understanding and management of this disease.
Chappuy, H; Doz, F; Blanche, S; Gentet, J‐C; Pons, G; Tréluyer, J‐M
Aims To assess parental understanding and memorisation of the information given when seeking for consent to their child's participation to clinical research, and to identify the factors of significant influence on parents' decision making process. Methods Sixty eight parents who had been approached for enrolling their child in a clinical oncology or HIV study were asked to complete an interview. Their understanding was measured by a score which included items required to obtain a valid consent according to French legislation. Results Items that were best understood by parents were the aims of the study (75%), the risks (70%), the potential benefits to their child (83%), the potential benefits to other children (70%), the right to withdraw (73%), and voluntariness (84%). Items that were least understood were the procedures (44%), the possibility of alternative treatments (53%), and the duration of participation (39%). Less than 10% of the parents had understood all these points. Ten parents (15%) did not remember that they had signed up for a research protocol. Thirty three parents (48%) reported no difficulty in making their decision. Twenty four parents (38%) declared that they made their decision together with the investigator; 26 (41%) let the physician decide. Fifty four parents (78%) felt that the level of information given was satisfactory. Conclusion There was an apparent discrepancy between parents' evaluation of the adequacy of the information delivered and evaluation of their understanding and memorisation. The majority of parents preferred that the physician take as much responsibility as possible in the decision making process. PMID:16246853
Dana, Nancy Fichtman
This paper describes a collaborative action research project conducted by a university researcher and a group of elementary school teachers. It examines the role the researcher plays when educational change is initiated by practitioners and the nature of the relationship that develops between researcher and practitioners throughout the change…
The NCI’s Division of Cancer Treatment and Diagnosis and the Cancer Diagnosis Program announce a request for applications for the Clinical Assay Development Program (CADP) for investigators seeking clinical assay development and validation resources.
Chenail, Ronald J.
From a perspective of patient-centered healthcare, exploring patients' (a) preconceptions, (b) treatment experiences, (c) quality of life, (d) satisfaction, (e) illness understandings, and (f) design are all critical components in improving primary health care and research. Utilizing qualitative approaches to discover patients' experiences can…
Frank, Ellen; Novick, Danielle; Kupfer, David J.
This review focuses on information concerning antidepressants and psychotherapy in the treatement of both acute and chronic forms of unipolar depression in the English language literature. In it, we address the use of combination therapy, both from the outset of treatment and in a variety of sequences, ie, we examine the potential advantages of adding a targeted psychotherapy to an incompletely effective pharmacotherapy and the potential advantages of adding pharmacotherapy to an incompletely effective psychotherapy The number of research reports available to address these questions is small relative to their importance for clinical practice. There is a clear need for more information about the relative efficacy of pharmacotherapy-psychotherapy combinations or sequences versus either pharmacotherapy or psychotherapy provided as monotherapies. PMID:16156384
Rosa, Vinicius; Bona, Alvaro Della; Cavalcanti, Bruno Neves; Nör, Jacques Eduardo
Tissue engineering is an interdisciplinary field that combines the principles of engineering, material and biological sciences toward the development of therapeutic strategies and biological substitutes that restore, maintain, replace or improve biological functions. The association of biomaterials, stem cells, growth and differentiation factors have yielded the development of new treatment opportunities in most of the biomedical areas, including Dentistry. The objective of this paper is to present the principles underlying tissue engineering and the current scenario, the challenges and the perspectives of this area in Dentistry. Significance The growth of tissue engineering as a research field have provided a novel set of therapeutic strategies for biomedical applications. The emerging knowledge arisen from studies in the dental area may translate into new methods for caring or improving the alternatives used to treat patients in the daily clinic. PMID:22240278
Meador, Kimford J
Marked changes in US medical school funding began in the 1960s with progressively increasing revenues from clinical services. The growth of clinical revenues slowed in the mid-1990s, creating a funding crisis for US academic health care centers, who responded by having their faculty increase their clinical duties at the expense of research activities. Surveys document the resultant stresses on the academic clinician researcher. The NIH provides greater funding for basic and translational research than for clinical research, and the new Patient-Centered Outcomes Research Institute is inadequately funded to address the scope of needed clinical research. An increasing portion of clinical research is funded by industry, which leaves many important clinical issues unaddressed. There is an inadequate supply of skilled clinical researchers and a lack of external support for clinical research. The impact on the academic environment in university medical centers is especially severe on young faculty, who have a shrinking potential to achieve successful academic careers. National health care research funding policies should encourage the right balance of life-science investigations. Medical universities need to improve and highlight education on clinical research for students, residents, fellows, and young faculty. Medical universities also need to provide appropriate incentives for clinical research. Without training to ensure an adequate supply of skilled clinical researchers and a method to adequately fund clinical research, discoveries from basic and translational research cannot be clinically tested and affect patient care. Thus, many clinical problems will continue to be evaluated and treated with inadequate or even absent evidence-based knowledge.
... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Laboratory Research and Development and Clinical Science Research and ] Development Services Scientific Merit.... Clinical Research Program June 9, 2010 *VA Central Office. Oncology June 10-11, 2010....... L'Enfant...
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Engel, Elaine Frances
Computer assisted career guidance (CACG) systems have been around for at least the past 20 years in career guidance centers. There are two types of systems: information retrieval and guidance interaction. This study investigated the effectiveness of DISCOVER in facilitating career decisions among college students. DISCOVER is a systematic career…
Grady, Christine; Edgerly, Maureen
Clinical research is a systematic investigation of human biology, health, or illness involving human beings. It builds on laboratory and animal studies and often involves clinical trials, which are specifically designed to test the safety and efficacy of interventions in humans. Nurses are critical to the conduct of ethical clinical research and face clinical, ethical, and regulatory challenges in research in many diverse roles. Understanding and addressing the ethical challenges that complicate clinical research is integral to upholding the moral commitment that nurses make to patients, including protecting their rights and ensuring their safety as patients and as research participants.
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.
De Deyn, P P; D'Hooge, R
The main current application of placebo is in clinical research. The term placebo effect refers to diverse non-specific, desired or non-desired effects of substances or procedures and interactions between patient and therapist. Unpredictability of the placebo effect necessitates placebo-controlled designs for most trials. Therapeutic and diagnostic use of placebo is ethically acceptable only in few well-defined cases. While "therapeutic" application of placebo almost invariably implies deception, this is not the case for its use in research. Conflicts may exist between the therapist's Hippocratic and scientific obligations. The authors provide examples in neuropsychiatry, illustrating that objective scientific data and well-considered guidelines may solve the ethical dilemma. Placebo control might even be considered an ethical obligation but some provisos should be kept in mind: (a) no adequate therapy for the disease should exist and/or (presumed) active therapy should have serious side-effects; (b) placebo treatment should not last too long; (c) placebo treatment should not inflict unacceptable risks, and (d) the experimental subject should be adequately informed and informed consent given. PMID:8798935
Lewis-Fernández, R; Kleinman, A
As a discipline, cultural psychiatry has matured considerably in recent years and the ongoing quality of its theoretical, clinical, and research development holds great promise. The contemporary emphasis on culture as process permits a deeper analysis of the complexities of sociosomatics--the translation of meanings and social relations into bodily experience--and, thus, of the social course of illness. We also are learning a great deal more about cultural processes that affect therapy, including ethnopharmacologic and culturally valid family interventions that are directly relevant to patient care and mental health policy. And an important set of studies is examining the trauma experienced by refugees and immigrants. But at the same time many disquieting findings still point to the limited impact of cultural psychiatry on knowledge creation and clinical application in psychiatry. The failure of the cultural validation of DSM-IV is only the most dismaying. The persistent misdiagnosis of minority patients and the continued presence of racial bias in some treatment recommendations are also disheartening, as is the seeming contempt of many mainstream psychiatrists for culturally defined syndromes and folk healing systems. Widespread inattention to ethnic issues in medical ethics is another source of dismay. It is for these reasons that the culture of psychiatry itself becomes as important as the culture of patients as a topic for research and intervention. Most of the world still suffers from a terrible lack of basic mental health services, including life-saving medications and hospital beds. In the face of these limitations, and because of the increasing multicultural and pluralistic reality of contemporary life, the growing interpretive bridges linking indigenous systems of illness classification and healing to Western nosologies and therapeutic modalities become even more essential and the reluctance of mainstream clinicians to explore folk healing methods more
Kahn, Michael G.; Batson, Deborah; Schilling, Lisa M.
Introduction Growing adoption of electronic health records and increased emphasis on the reuse and integration of clinical care and administration data require a robust informatics infrastructure to inform health care effectiveness in real-world settings. The Scalable Architecture for Federated Translational Inquiries Network (SAFTI Net) was one of 3 projects receiving Agency for Healthcare Quality and Research funds to create a scalable, distributed network to support Comparative Effectiveness Research. SAFTINet’s method of extracting and compiling data from disparate entities requires the use of a shared common data model. Data Models Focusing on the needs of CER investigators, in addition to other project considerations, we examined the suitability of several data models. Data modeling is the process of determining which data elements will be stored and how they will be stored, including their relationships and constraints. Addressing compromises between complexity and usability is critical to modeling decisions. Case Study The SAFTINet project provides the case study for describing data model evaluation. A sample use case defines a cohort of asthma subjects that illustrates the need to identify patients by age, diagnoses, and medication use while excluding those with diagnoses that may often be misdiagnosed as asthma. Discussion The SAFTINet team explored several data models against a set of technical and investigator requirements to select a data model that best fit its needs and was conducive to expansion with new research requirements. Although SAFTINet ultimately chose the Observation Medical Outcomes Partnership common data model, other valid options exist and prioritization of requirements is dependent upon many factors. PMID:22692260
A clinical study must address true endpoints that matter for the patients and the doctors. A good clinical study starts with a good clinical question. Formulating a clinical question in the form of PECO can sharpen one's original question. In order to perform a good clinical study one must have a knowledge of study design, measurements and statistical analyses: The first is taught by epidemiology, the second by psychometrics and the third by biostatistics.
Wallington, Sherrie Flynt; 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 non-therapeutic 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. PMID:26470805
Navarro-Chumbes, Gian Carlos; Montano-Torres, Silvia Margarita; Díaz-Vásquez, Alberto; Zunt, Joseph Raymond
In Peru, despite a strong clinical research infrastructure in Lima, and Masters degree programs in epidemiology at three universities, few neurologists participate in clinical research. It was our objective to identify perceived needs and opportunities for increasing clinical research capacity and training opportunities for Peruvian neurologists. We conducted a descriptive, cross-sectional survey of Peruvian neurologists in Lima and Arequipa, Peru. Forty-eight neurologists completed written surveys and oral interviews. All neurologists reported interest in clinical research, but noted that lack of time and financial resources limited their ability to participate. Although most neurologists had received some training in epidemiology and research design as medical students or residents, the majority felt these topics were not adequately covered. Neurologists in Arequipa noted international funding for clinical research was uncommon outside the capital city of Lima. We concluded that clinical research is important to Peruvian neurologists. The three main barriers to increased participation in clinical research identified by neurologists were insufficient training in clinical research methodology, meager funding opportunities, and lack of dedicated time to participate in clinical research. Distance learning holds promise as a method for providing additional training in clinical research methodology, especially for neurologists who may have difficulty traveling to larger cities for additional training.
Demotes-Mainard, J; Kubiak, C
Evaluating research outcomes requires multinational cooperation in clinical research for optimization of treatment strategies and comparative effectiveness research, leading to evidence-based practice and healthcare cost containment. The European Clinical Research Infrastructures Network (ECRIN) is a distributed ESFRI (European Strategy Forum on Research Infrastructures) roadmap pan-European infrastructure designed to support multinational clinical research, making Europe a single area for clinical studies, taking advantage of its population size to access patients, and unlocking latent scientific potential. Servicing multinational trials started during its preparatory phase, and ECRIN will now apply for an ERIC (European Research Infrastructures Consortium) status by 2011. By creating a single area for clinical research in Europe, this achievement will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of the research and education capacity, tackling the major societal challenges starting with the area of healthy ageing, and removing barriers to bring ideas to the market.
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.
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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.
Goracci, Arianna; Casamassima, Francesco; Iovieno, Nadia; di Volo, Silvia; Benbow, Jim; Bolognesi, Simone; Fagiolini, Andrea
This case report describes the clinical course of a young woman suffering from binge eating disorder (BED) associated with obesity. It illustrates the efficacy of different medications in the treatment of BED and related conditions and is followed by the comments and clinical observations of 2 practicing psychiatrists. The issues described in this paper have important clinical implications and are topical, given that BED is now recognized as a specific disorder in the new Diagnostic and Statistical Manual of Mental Disorders, fifth edition classification system, but neither the US Food and Drug Administration nor any other regulatory agency has yet approved a drug for treatment of this disease, despite its very prevalent and disabling nature. Growing evidence from the fields of psychopathology and neurobiology, including preclinical and clinical studies, converges to support the idea that "overeating" has much in common with other behavioral addictions, and substance abuse treatment agents may show promise for the treatment of BED.
Traystman, Richard J.
Discusses in general the importance of a research division, whether basic or clinical, in an academic setting and factors to consider in establishing one. Uses John Hopkins' newly created research division for Anesthesiology and Critical Care Medicine to specifically address funding and intra- and interdepartmental clinical research programs. (DC)
J. Michael McGehee
The Institute for Clinical PET and the U.S. Department of Energy (DOE) co-sponsored a symposium entitled 'Research in PET: International and Institutional Perspectives' that highlighted the activities of many leading investigators in the U.S. and throughout the world. Research programs at the DOE were discussed as were potential directions of PET research. International as well as institutional perspectives on PET research were presented. This symposium was successful in reaching those interested in research advances of clinical PET.
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.
Weijer, C; Shapiro, S; Fuks, A; Glass, K C; Skrutkowska, M
The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research. PMID:7780907
Fraud and misconduct in clinical research is widespread. Good clinical practice is a guideline adopted internationally as standard operating procedure for conduct of clinical research. Despite these guidelines being available, unavailability of internationally harmonized framework for managing research fraud and misconduct makes clinical research a highly vulnerable area to commit fraud. Fraud could be of various types and due to various reasons. Whatever the circumstances be, any fraud should be dealt with strictly and regulations should be in place to prevent its occurrence. PMID:23833741
Long, Erping; Huang, Bingjie; Wang, Liming; Lin, Xiaoyu; Lin, Haotian
Widely used in clinical research, the database is a new type of data management automation technology and the most efficient tool for data management. In this article, we first explain some basic concepts, such as the definition, classification, and establishment of databases. Afterward, the workflow for establishing databases, inputting data, verifying data, and managing databases is presented. Meanwhile, by discussing the application of databases in clinical research, we illuminate the important role of databases in clinical research practice. Lastly, we introduce the reanalysis of randomized controlled trials (RCTs) and cloud computing techniques, showing the most recent advancements of databases in clinical research.
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Milner, F Margaret; Estabrooks, C A; Humphrey, C
The purpose of this study was to examine the determinants of research utilization among clinical nurse educators. The primary goal for clinical nurse educators is the facilitation of professional development of practicing nurses. Responsibilities include promoting best practice by mentoring others, acting as an information source, and assisting in the development of policies and procedures based on available research evidence. Using Rogers' (Diffusion of Innovations, 4th edn., The Free Press, New York) diffusion of innovations theory as a theoretical foundation, we conducted a secondary analysis to test a predictive model of research utilization using linear regression. Results show that educators report significantly higher research use than staff nurses and managers. Predictors of research utilization include attitude toward research, awareness of information based on research, and involvement in research activities. Localite communication predicted conceptual research use and mass media predicted symbolic use, lending support to the idea that overall, instrumental, conceptual, and symbolic research utilization are conceptually different from one another. Our findings show that the research utilization behaviors of clinical nurse educators position them to facilitate evidence-based nursing practice in organizations. We discuss the theoretical, conceptual, and nursing role implications of our findings for nursing practice, education, and research. Suggestions for future research includes studying actual use of research findings of clinical nurse educators and designing intervention studies that assesses the effectiveness of clinical nurse educators as facilitators of research utilization in organizations.
Coorevits, P; Sundgren, M; Klein, G O; Bahr, A; Claerhout, B; Daniel, C; Dugas, M; Dupont, D; Schmidt, A; Singleton, P; De Moor, G; Kalra, D
Clinical research is on the threshold of a new era in which electronic health records (EHRs) are gaining an important novel supporting role. Whilst EHRs used for routine clinical care have some limitations at present, as discussed in this review, new improved systems and emerging research infrastructures are being developed to ensure that EHRs can be used for secondary purposes such as clinical research, including the design and execution of clinical trials for new medicines. EHR systems should be able to exchange information through the use of recently published international standards for their interoperability and clinically validated information structures (such as archetypes and international health terminologies), to ensure consistent and more complete recording and sharing of data for various patient groups. Such systems will counteract the obstacles of differing clinical languages and styles of documentation as well as the recognized incompleteness of routine records. Here, we discuss some of the legal and ethical concerns of clinical research data reuse and technical security measures that can enable such research while protecting privacy. In the emerging research landscape, cooperation infrastructures are being built where research projects can utilize the availability of patient data from federated EHR systems from many different sites, as well as in international multilingual settings. Amongst several initiatives described, the EHR4CR project offers a promising method for clinical research. One of the first achievements of this project was the development of a protocol feasibility prototype which is used for finding patients eligible for clinical trials from multiple sources.
Berger, Vance W; Matthews, J Rosser; Grosch, Eric N
Research plays a vital role within biomedicine. Scientifically appropriate research provides a basis for appropriate medical decisions; conversely, inappropriate research may lead to flawed ;best medical practices' which, when followed, contribute to avoidable morbidity and mortality. Although an all-encompassing definition of ;appropriate medical research' is beyond the scope of this article, the concept clearly entails (among other things) that research methods be continually revised and updated as better methods become available. Despite the advent of evidence-based medicine, many research methods have become ;standard' even though there are legitimate scientific reasons to question the conclusions reached by such methods. We first illustrate prominent examples of inappropriate (yet regimented) research methods that are in widespread use. Second, as a way to improve the situation, we suggest a model of research that relies on standardized statistical analyses that individual researchers must consider as a default, but are free to challenge when they can marshal sufficient scientific evidence to demonstrate that the challenge is warranted. Third, we characterize the current system as analogous to ;unnatural selection' in the biological world and argue that our proposed model of research will enable ;natural' to replace ;unnatural' selection in the choice of research methodologies. Given the pervasiveness of inappropriate research methods, we believe that there are strong scientific and ethical reasons to create such a system, that, if properly designed, will both facilitate creativity and ensure methodological rigor while protecting the public at large from the threats posed by poor medical treatment decisions resulting from flawed research methodology.
Vawdrey, David K; Weng, Chunhua; Herion, David; Cimino, James J
The "Learning Health System" has been described as an environment that drives research and innovation as a natural outgrowth of patient care. Electronic health records (EHRs) are necessary to enable the Learning Health System; however, a source of frustration is that current systems fail to adequately support research needs. We propose a model for enhancing EHRs to collect structured and standards-based clinical research data during clinical encounters that promotes efficiency and computational reuse of quality data for both care and research. The model integrates Common Data Elements (CDEs) for clinical research into existing clinical documentation workflows, leveraging executable documentation guidance within the EHR to support coordinated, standardized data collection for both patient care and clinical research.
Roos, J C
Pharmaceutical industry and physician-investigators are mutually dependent for the development of new drugs and clinical trials of such drugs. Under pressure of increasing market orientation, clinical scientific investigations shift more and more from fundamental to clinical drug trials, the results of which sometimes do not justify the excitement with which they are presented in the scientific and lay press. More room and means should be given to less market oriented studies, addressing more fundamental clinical problems. Financial affiliation with the industry may influence the doctors' mind and the presentation and type of investigation. Apart from this type of intellectual subjection there is a form of financial subjugation of doctors to the industry, by participating in so-called 'postmarketing surveillance studies' which they in fact are not, that have no scientific value whatsoever, but only serve the financial interest of the participating doctor and the industry.
Gao, Hong-yang; Li, Qing-na; Zhao, Yang; Li, Bo; Rui, Gao
Current clinical evaluation of literature quality has various ways. Most of them lay special emphasis on the evaluation of the design quality, but the evaluation of the implementation process quality is not perfect. Especially data management is not fully emphasized during the enforcement of clinical trials. Data from clinical research were bases for evaluating clinical findings. Although strict specifications and requirements for data management might be strictly written clearly in research protocols, they were not embodied in current clinical research evidence evaluation system. Data management is an important part of implementing the whole clinical trial process, which is a comprehensive reflection of data collecting, logging, sorting, and managing. Its objective is to obtain high quality research data for statistical analysis, thereby coming to a true and reliable conclusion. In order to overall evaluating clinical design and implement, we suggest that present quality evaluation indicators of clinical trails should be completed, and add data management quality evaluation during the whole implement process. Data management plans, standards and requirements for data checking, and management regulations for disobeying data and exception data should be added in quality evaluation indicators for clinical research evidence. The effect of data management quality on clinical research evidence evaluation should be emphasized.
Well-known exoplanet researcher Michel Mayor today announced the discovery of the lightest exoplanet found so far. The planet, "e", in the famous system Gliese 581, is only about twice the mass of our Earth. The team also refined the orbit of the planet Gliese 581 d, first discovered in 2007, placing it well within the habitable zone, where liquid water oceans could exist. These amazing discoveries are the outcome of more than four years of observations using the most successful low-mass-exoplanet hunter in the world, the HARPS spectrograph attached to the 3.6-metre ESO telescope at La Silla, Chile. ESO PR Photo 15a/09 Artist's impression of Gliese 581 e ESO PR Photo 15b/09 A planet in the habitable zone ESO PR Video 15a/09 ESOcast 6 ESO PR Video 15b/09 VNR A-roll ESO PR Video 15c/09 Zoom-in on Gliese 581 e ESO PR Video 15d/09 Artist's impression of Gliese 581 e ESO PR Video 15e/09 Artist's impression of Gliese 581 d ESO PR Video 15f/09 Artist's impression of Gliese 581 system ESO PR Video 15g/09 The radial velocity method ESO PR Video 15h/09 Statement in English ESO PR Video 15i/09 Statement in French ESO PR Video 15j/09 La Silla Observatory "The holy grail of current exoplanet research is the detection of a rocky, Earth-like planet in the ‘habitable zone' -- a region around the host star with the right conditions for water to be liquid on a planet's surface", says Michel Mayor from the Geneva Observatory, who led the European team to this stunning breakthrough. Planet Gliese 581 e orbits its host star - located only 20.5 light-years away in the constellation Libra ("the Scales") -- in just 3.15 days. "With only 1.9 Earth-masses, it is the least massive exoplanet ever detected and is, very likely, a rocky planet", says co-author Xavier Bonfils from Grenoble Observatory. Being so close to its host star, the planet is not in the habitable zone. But another planet in this system appears to be. From previous observations -- also obtained with the HARPS spectrograph
The organisation of clinical research in French teaching hospitals has been profoundly modified over the past 15 years. The first call for clinical research projects was made by the Ministry of Health in 1993. This Hospital Program for Clinical Research was created by the public welfare system, a situation unique in Europe and the USA at the time. Every year since 1993, new clinical research projects have been supported through this program. In 2007, more than 14 million euros was provided for clinical research in oncology more than 21 million euros for clinical research in other fields, and more than 11 million euros through interregional grants. Overall, more than 50 million euros will be provided in 2008 to support clinical research with public sponsorship in French teaching hospitals. Major organisational changes were made to support this unprecedented financial effort in favor of clinical research. In each of the 29 French teaching hospitals, a Delegation for Clinical Research (DRC) was created to promote public sponsorship of clinical trials, to monitor these trials, to guarantee that Good Clinical Practices are respected, and to control the financial aspects of research projects. Clinical Research Assistants were recruited by DRC to monitor clinical trials. Clinical Investigation Centers (CIC) were organized in conjunction with teaching hospitals and with the French biomedical research council (INSERM). Today, there are 54 CICs located in 23 teaching hospitals, conducting clinical trials and other research in epidemiology and biotechnology. In May 2005, seven interregional delegations for clinical research (DIRC) were created to coordinate these activities on a regional basis. The aim was to improve scientific collaboration between teaching hospitals in a given region, to organize the training of clinical investigators and technicians, and to support the development of clinical trial monitoring, quality assurance, and pharmacovigilance. A 2006 survey of
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…
Nail, Lillian M.; Lange, Linda L.
Addresses the recognition of differences between clinical and research data in using computerized clinical nursing databases and the issues of privacy and confidentiality for patients whose records are involved. Describes procedures for assessing the quality and usability of these data for nursing research. (SK)
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)
Describes a personal artistic struggle against heroin addiction, advising teachers of the difficulty of working to discover and express one's developing self. Considers the effect of poetry and philosophy on the developing creative process. Provides samples of the author's own poetry to demonstrate creative development, as an example to Montessori…
Working with teachers and artists from Florida to Maine, a drama educator has discovered that creative power and insight can emerge when using drama in the language arts classroom. One seventh-grade class began with simple warm-ups to loosen inhibitions and then moved into a unit that dealt with improvising using movement. A student who had hardly…
Presents an activity that introduces the historical developments in science that led to the discovery of the periodic table and lets students experience scientific discovery firsthand. Enables students to learn about patterns among the elements and experience how scientists analyze data to discover patterns and build models. (JRH)
... DISCOVER-AQ ) is a four-year campaign to improve the use of satellites to monitor air quality for public health and environmental benefit. ... will enable more effective use of current and future satellites to diagnose ground level conditions influencing air quality. ...
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. PMID:23938129
number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. 1. REPORT DATE October 2015 2. REPORT TYPE Annual 3. DATES COVERED 30 Sep 2014 - 29...David Nanus CONTRACTING ORGANIZATION: Weill Medical College of Cornell University New York, NY 10065 REPORT DATE: October 2015 TYPE OF REPORT ... Annual PREPARED FOR: U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for
... Development and Clinical Science Research and Development Services Scientific Merit Review Board, Notice of... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... science research. The panel meetings will be open to the public for approximately one-half hour at...
Simeon-Dubach, Daniel; Zeisberger, Steffen M.; Hoerstrup, Simon P.
It is estimated that not less than USD 28 billion are spent each year in the USA alone on irreproducible pre-clinical research, which is not only a fundamental loss of investment and resources but also a strong inhibitor of efficiency for upstream processes regarding the translation towards clinical applications and therapies. The issues and cost of irreproducibility has mainly been published on pre-clinical research. In contrast to pre-clinical research, test material is often being transferred into humans in clinical research. To protect treated human subjects and guarantee a defined quality standard in the field of clinical research, the manufacturing and processing infrastructures have to strictly follow and adhere to certain (inter-)national quality standards. It is assumed and suggested by the authors that by an implementation of certain quality standards within the area of pre-clinical research, billions of USD might be saved and the translation phase of promising pre-clinical results towards clinical applications may substantially be improved. In this review, we discuss how an implementation of a quality assurance (QA) management system might positively improve sample quality and sustainability within pre-clinically focused biobank infrastructures. Biobanks are frequently positioned at the very beginning of the biomedical research value chain, and, since almost every research material has been stored in a biobank during the investigated life cycle, biobanking seems to be of substantial importance from this perspective. The role model of a QA-regulated biobank structure can be found in biobanks within the context of clinical research organizations such as in regenerative medicine clusters. PMID:27781023
Nathan, David G.
Perhaps because I am a veteran of the “good old days” (they were really quite bad), young physicians who hope to become clinical investigators often ask me how they might establish their careers. Many are more than a little worried about their futures and often have trouble envisioning a career path that is financially secure for themselves and their families. The grumbling of clinical investigators a few years their senior enhances their angst. So I try to encourage these young physicians because I know the great intellectual (if not monetary) rewards of the field and because I know that the future of medicine absolutely depends on clinical investigators. The following is what I try to say to them. PMID:15841166
Orientation, training, and in-service programs are designed to provide assurance that nursing care standards will be met. Describes how to familiarize staff with the meaning of research, with its demand for repetition and precision, and the many ways in which nursing personnel actually provide support to the research physician. (RB)
Ilersich, A. Lane; And Others
Original research articles from three major pharmacy journals were reviewed to determine the quality of reporting research. Articles were evaluated for method of recruitment and/or randomization; statistical analysis; inclusion/exclusion criteria; subject blinding; objective assessment; treatment complications; loss to followup; number of…
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.
Sawyer, C; Haas, M; Nelson, C; Elkington, W
In the current climate of accountability, health care financing reform and the demand on all health professions for evidence, there is an urgent need to expand clinical research activity within the profession. Those randomized clinical trials that have been reported in the literature have focused primarily on low back and headache pain. Only recently have studies been initiated to investigate the effectiveness of chiropractic interventions for conditions other than back pain. The ability of chiropractic colleges to develop research infrastructures and productive clinical research programs depends on removing or minimizing a number of impediments. A shortage of chiropractic clinicians who have the experience and training to conduct clinical research is compounded by a dependency on tuition revenue, limited external funding and a lack of institutional emphasis on research. The profession generally, and chiropractic colleges specifically, must address the impediments that limit the growth of research capacity. We present several recommendations and the action steps required to achieve specific outcomes.
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.
... drug and who is in the control group. Studies are performed in this way so that neither the patients' nor the doctors' expectations about the experimental drug can influence the observations and results. Top of page Should I volunteer for clinical ...
van den Berg, L; Lobatto, R M; Zuurmond, W W; de Lange, J J; Wagemans, M F; Bezemer, P D
The number of protocol-eligible patients, refusing to participate in a clinical trial is often not mentioned. The aim of this study is to report the number of refusers and to evaluate the reasons for not participating in a clinical study concerning post-operative pain relief and to assess the potential influence on the final study results. Patients refusing to participate in the study were recorded and evaluated for reasons of refusal. The post-operative pain relief techniques applied in this trial are commonly used, but nevertheless the refusal rate was higher than expected. When it was mentioned that an epidural technique was a part of the trial, 16.7% of the total protocol-eligible group refused. The responses of those offered an epidural could be divided into two groups: the adamant pros and cons to this technique. It can be concluded that in order to be able to judge the validity of results and thus for good clinical practice, the number of patients refusing to participate in a clinical trial and their reasons, should be mentioned in all publications.
Highlights Stanford University's 220,000 square-foot Center for Clinical Sciences, the design of which represents a high-quality architectural departure from the old building styles and creates an elegant, solar-protected gathering place for scientists. Includes photographs, sectional drawing, and site plan. (GR)
Nayar, Veena R.; Morrey, Michael A.; Schneider, Kenneth J.; Purrington, Anne W.; Wilshusen, Laurie L.; Mullen, Michael P.; Seltman, Kent D.
Discusses a collaborative study between Mayo Clinic's departments of human resources and marketing to identify the factors that influence candidates' decisions to accept or decline job offers and the reasons behind staff resignations. Study aimed to increase the effectiveness of employee recruitment advertising, streamline its interviewing…
Rivas-Ruiz, Rodolfo; Pérez-Rodríguez, Marcela; Palacios, Lino; Talavera, Juan O
Decision making in health care implies knowledge of the clinical course of the disease. Knowing the course allows us to estimate the likelihood of occurrence of a phenomenon at a given time or its duration. Within the statistical models that allow us to have a summary measure to estimate the time of occurrence of a phenomenon in a given population are the linear regression (the outcome variable is continuous and normally distributed -time to the occurrence of the event-), logistic regression (outcome variable is dichotomous, and it is evaluated at one single interval), and survival curves (outcome event is dichotomous, and it can be evaluated at multiple intervals). The first reference we have of this type of analysis is the work of the astronomer Edmond Halley, an English physicist and mathematician, famous for the calculation of the appearance of the comet orbit, recognized as the first periodic comet (1P/Halley's Comet). Halley also contributed in the area of health to estimate the mortality rate for a Polish population. The survival curve allows us to estimate the probability of an event occurring at different intervals. Also, it leds us to estimate the median survival time of any phenomenon of interest (although the used term is survival, the outcome does not need to be death, it may be the occurrence of any other event).
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.
Talavera, Juan O; Rivas-Ruiz, Rodolfo
Two strategies to understand and document causality are: 1) clinical reasoning (CR) and 2) clinical trial (CT). CR identifies: basal state, maneuver and outcome. These components show us the complex of causality, its identification and control allows us to avoid systematic errors, such as: at baseline-improper assembly and susceptibility bias, during the application of the maneuver-performance bias, and at measurement of outcome-detection and transfer bias. In the CT tactics attempt to separate the effect of the main maneuver from the effect of other components that participate in causality previously described in CR. CT takes advantage of its characteristics: the opportunity to manipulate the maneuver and the temporality into the causal relationship. Some features to highlight are: the allocation of the maneuver, blinding of the maneuver, the feasibility of early interruption of the maneuver, the analysis according to maneuver adherence, the groups to compare, the timing of comparative maneuver, and the informed consent. Each occasion the clinician applies all this knowledge and skills, in a conscious way and structured, he improves his efficiency and align medical practice with clinical research.
Desmond, A; Stanton, A; Maher, V; Crean, P; Feely, J; Sullivan, P
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.
Summary Objectives To select and summarize key contributions to current research in the field of Clinical Research Informatics (CRI). Method: A bibliographic search using a combination of MeSH and free terms search over PubMed was performed followed by a blinded review. Results The review process resulted in the selection of four papers illustrating various aspects of current research efforts in the area of CRI. The first paper tackles the challenge of extracting accurate phenotypes from Electronic Healthcare Records (EHRs). Privacy protection within shared de-identified, patient-level research databases is the focus of the second selected paper. Two other papers exemplify the growing role of formal representation of clinical data - in metadata repositories - and knowledge – in ontologies - for supporting the process of reusing data for clinical research. Conclusions The selected articles demonstrate how concrete platforms are currently achieving interoperability across clinical research and care domains and have reached the evaluation phase. When EHRs linked to genetic data have the potential to shift the research focus from research driven patient recruitment to phenotyping in large population, a key issue is to lower patient re-identification risks for biomedical research databases. Current research illustrates the potential of knowledge engineering to support, in the coming years, the scientific lifecycle of clinical research. PMID:25123747
Villalobos, J J
Ethics is the branch of Philosophy that treats the essential; the origin and the obligatory character of the moral, for that reason it relates with the man conscience; it deals with the knowledge and acceptation of the right and the rejection of the evil (wrong). This is subordinated to the will of the man who is free to decide between the right and the evil. The purpose of biomedical research involving human subjects must help to improve diagnostic, therapeutic and prophylactic procedures and to understand the aetiology and pathogenesis of a disease. In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazard. This applies especially to biomedical research. Medical progress is based on research which ultimately must rely in part on experimentation involving human subjects. The World Medical Association has prepared the recommendations described in this article as a guide to every physician in biomedical research involving human subjects.
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.
Jones, Barrie W.
Discovering the Solar System Barrie W. Jones The Open University, Milton Keynes, UK Discovering the Solar System is a comprehensive, up-to-date account of the Solar System and of the ways in which the various bodies have been investigated and modelled. The approach is thematic, with sequences of chapters on the interiors of planetary bodies, on their surfaces, and on their atmospheres. Within each sequence there is a chapter on general principles and processes followed by one or two chapters on specific bodies. There is also an introductory chapter, a chapter on the origin of the Solar System, and a chapter on asteroids, comets and meteorites. Liberally illustrated with diagrams, black and white photographs and colour plates, Discovering the Solar System also features: * tables of essential data * question and answers within the text * end of section review questions with answers and comments Discovering the Solar System is essential reading for all undergraduate students for whom astronomy or planetary science are components of their degrees, and for those at a more advanced level approaching the subject for the first time. It will also be of great interest to non-specialists with a keen interest in astronomy. A small amount of scientific knowledge is assumed plus familiarity with basic algebra and graphs. There is no calculus. Praise for this book includes: ".certainly qualifies as an authoritative text. The author clearly has an encyclopedic knowledge of the subject." Meteorics and Planetary Science ".liberally doused with relevant graphs, tables, and black and white figures of good quality." EOS, Transactions of the American Geophysical Union ".one of the best books on the Solar System I have seen. The general accuracy and quality of the content is excellent." Journal of the British Astronomical Association
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…
Diekelmann, Nancy L.; And Others
A new way to view the nursing curriculum is presented based on Heideggerian phenomenology and clinical nursing knowledge research. A restructuring of the nursing curriculum based on this approach allows researchers to generate new research questions and has implications for alternative curricular and instructional practices. In addition, this…
Summary Objectives To select and summarize key constributions to current research and to select best papers published in 2014 in the field of Clinical Research Informatics (CRI). Method 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 literature review. Results The review process yielded four papers, illustrating various aspects of current research efforts done in the area of CRI. The first paper exemplifies the process of developping a domain ontology for integrating structured, unstructured, and signal data into a coherent structure for patient care as well as clinical research. In the second paper, the authors analysed in five sites’ hospital information system environments in Germany the possibility of implementing a patient recruitment process and provided recommendations for the development of dedicated patient recruitment modules. The third paper describes the IMI EHR4CR project which developed an instance of a platform, providing communication, security and semantic interoperability services to the eleven participating hospitals and ten pharmaceutical companies located in seven European countries. The last paper describes the relation between health status severity and the availability of data in EHR systems. They demonstrate that it introduces a biasis in patient selection for clinical research. Conclusions Distributed research networks are growing in importance for clinical research and population health surveillance and current research demonstartes that different projects and initiatives could be well placed to deliver international scale solutions to enable the reuse of hospital EHR data to support clinical research studies. Selected articles demonstrate the potential of formal representation of multimodal and multi-level data in supporting data interoperability across clinical research and care domains. With the development of
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.
Pneumocystis pneumonia (PcP) remains a significant cause of morbidity and mortality in immunocompromised persons, especially those with human immunodeficiency virus (HIV) infection. Pneumocystis colonization is described increasingly in a wide range of immunocompromised and immunocompetent populations and associations between Pneumocystis colonization and significant pulmonary diseases such as chronic obstructive pulmonary disease (COPD) have emerged. This mini-review summarizes recent advances in our clinical understanding of Pneumocystis and PcP, describes ongoing areas of clinical and translational research, and offers recommendations for future clinical research from researchers participating in the "First centenary of the Pneumocystis discovery".
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.
Summary Objectives To summarize significant developments in Clinical Research Informatics (CRI) over the past two years and discuss future directions. Methods Survey of advances, open problems and opportunities in this field based on exploration of current literature. Results Recent advances are structured according to three use cases of clinical research: Protocol feasibility, patient identification/recruitment and clinical trial execution. Discussion CRI is an evolving, dynamic field of research. Global collaboration, open metadata, content standards with semantics and computable eligibility criteria are key success factors for future developments in CRI. PMID:26293865
Keevil, C. William; Salgado, Cassandra D.; Schmidt, Michael G.
Objective: This is a translational science article that discusses copper alloys as antimicrobial environmental surfaces. Bacteria die when they come in contact with copper alloys in laboratory tests. Components made of copper alloys were also found to be efficacious in a clinical trial. Background: There are indications that bacteria found on frequently touched environmental surfaces play a role in infection transmission. Methods: In laboratory testing, copper alloy samples were inoculated with bacteria. In clinical trials, the amount of live bacteria on the surfaces of hospital components made of copper alloys, as well as those made from standard materials, was measured. Finally, infection rates were tracked in the hospital rooms with the copper components and compared to those found in the rooms containing the standard components. Results: Greater than a 99.9% reduction in live bacteria was realized in laboratory tests. In the clinical trials, an 83% reduction in bacteria was seen on the copper alloy components, when compared to the surfaces made from standard materials in the control rooms. Finally, the infection rates were found to be reduced by 58% in patient rooms with components made of copper, when compared to patients' rooms with components made of standard materials. Conclusions: Bacteria die on copper alloy surfaces in both the laboratory and the hospital rooms. Infection rates were lowered in those hospital rooms containing copper components. Thus, based on the presented information, the placement of copper alloy components, in the built environment, may have the potential to reduce not only hospital-acquired infections but also patient treatment costs. PMID:26163568
La Rue, Asenath; Markee, Taryn
Methodological issues in geropsychological assessment research are discussed and illustrated through recent investigations. Cross-sectional studies are needed to extend and diversify age norms, and short-term longitudinal studies should be planned to assess the predictive validity of test outcomes and diagnostic profiles of older adults. (SLD)
Blixen, Carol E.; Papp, Klara K.; Hull, Alan L.; Rudick, Richard A.; Bramstedt, Katrina A.
Introduction: In academic health centers, the number of physician investigators and the number of research studies headed by clinicians has been declining. The U.S. Institute of Medicine and the National Institutes of Health suggest improved mentoring is important to reversing these trends. Methods: This is a case study review of the role of…
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…
ER D C/ CE RL T R - 12 -2 1 Center Directed Research Program Digital Discover of Ephemeral Ponds En gi ne er R es ea rc h an d D ev el...r.mapcalc formula : r.terraflow lidar_elev filled=elev_filled \\ accum=elev_accum memory=2000 \\ dir=elev_dir swater=elev_sink tci =elev_tci...J. D., M. Shapiro, W. D. Goran, and D. P. Gerdes. 1992. Geographic Resources Analysis Support System (GRASS) Version 4.0 User’s Reference Manual . N
Horvath, M. M.; Rusincovitch, S. A.
Summary Objectives The goal of this survey is to discuss the impact of the growing availability of electronic health record (EHR) data on the evolving field of Clinical Research Informatics (CRI), which is the union of biomedical research and informatics. Results Major challenges for the use of EHR-derived data for research include the lack of standard methods for ensuring that data quality, completeness, and provenance are sufficient to assess the appropriateness of its use for research. Areas that need continued emphasis include methods for integrating data from heterogeneous sources, guidelines (including explicit phenotype definitions) for using these data in both pragmatic clinical trials and observational investigations, strong data governance to better understand and control quality of enterprise data, and promotion of national standards for representing and using clinical data. Conclusions The use of EHR data has become a priority in CRI. Awareness of underlying clinical data collection processes will be essential in order to leverage these data for clinical research and patient care, and will require multi-disciplinary teams representing clinical research, informatics, and healthcare operations. Considerations for the use of EHR data provide a starting point for practical applications and a CRI research agenda, which will be facilitated by CRI’s key role in the infrastructure of a learning healthcare system. PMID:25123746
Despite great strides in proteomics and the growing number of articles citing the discovery of potential biomarkers, the actual rate of introduction of Food and Drug Administration (FDA) approved protein analytes has been relatively unchanged over the past 10 years. One of reasons for the lack of new protein-based biomarkers approved has been a lack of information and understanding by the proteomics research community to the regulatory process used by the FDA.
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.
Hussong, Andrea M; Curran, Patrick J; Bauer, Daniel J
Integrative data analysis (IDA), a novel framework for conducting the simultaneous analysis of raw data pooled from multiple studies, offers many advantages including economy (i.e., reuse of extant data), power (i.e., large combined sample sizes), the potential to address new questions not answerable by a single contributing study (e.g., combining longitudinal studies to cover a broader swath of the lifespan), and the opportunity to build a more cumulative science (i.e., examining the similarity of effects across studies and potential reasons for dissimilarities). There are also methodological challenges associated with IDA, including the need to account for sampling heterogeneity across studies, to develop commensurate measures across studies, and to account for multiple sources of study differences as they impact hypothesis testing. In this review, we outline potential solutions to these challenges and describe future avenues for developing IDA as a framework for studies in clinical psychology.
Payne, Philip R.O.; Greaves, Andrew W.; Kipps, Thomas J.
The Chronic Lymphocytic Leukemia (CLL) Research Consortium (CRC) consists of 9 geographically distributed sites conducting a program of research including both basic science and clinical components. To enable the CRC’s clinical research efforts, a system providing for real-time collaboration was required. CTMS provides such functionality, and demonstrates that the use of novel data modeling, web-application platforms, and management strategies provides for the deployment of an extensible, cost effective solution in such an environment. PMID:14728471
The NCI's Clinical Proteomic Technologies for Cancer (CPTC) initiative has made tremendous progress knocking down barriers to the field which is indicative of both the dedication to the highest quality of research by its investigators and commitment to open standards.
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.
The National Cancer Institute (NCI), through the Office of Cancer Clinical Proteomics Research (OCCPR), has signed two Memorandums of Understanding (MOUs) in the areas of sharing proteomics reagents and protocols and also in regulatory science.
Bahill, A.T.; Bentz, B.; Dean, F.F.
Cost and schedule overruns are often caused by poor requirements that are produced by people who do not understand the requirements process. This report provides a high-level overview of the system requirements process, explaining types, sources, and characteristics of good requirements. System requirements, however, are seldom stated by the customer. Therefore, this report shows ways to help you work with your customer to discover the system requirements. It also explains terminology commonly used in the requirements development field, such as verification, validation, technical performance measures, and the various design reviews.
Disparities in cancer care are a reality of the modern world. Unfortunately, current clinical research is in the hands of for-profit pharmaceutical companies and of researchers from the developed world. Problems specific to cancer care in developing countries and among deprivileged populations are ignored. Independent clinical research can offer new valuable knowledge and identify affordable and cost-effective treatments. As such, research not depending on commercial sponsors should become one of the important avenues to alleviate the problem of cancer disparities. PMID:28083547
Doss, Sheila; Schiller, Brigitte; Fox, Rosemary; Moran, John
Performing clinical research in the outpatient dialysis facility can be very challenging. Research protocols define time-specific and detailed procedures to be performed. In dialysis units where staff members are responsible for the delivery of life-sustaining therapy to an aging end stage renal disease patient population with multiple co-morbidities, these requirements can easily be considered too burdensome to be implemented successfully. In the authors'facility, clinical research has been successfully implemented with a close team approach supported by a dedicated research group and unit staff
Nardell, Maria; Chhabra, Akansha; Pal, Lubna
Participation in clinical research projects may allow an opportunity for early detection of covert diseases and subclinical disorders in asymptomatic volunteers from study-specific screening process. Exclusion of a potential participant due to failure to meet inclusion criteria eliminates any possibility of potential for research related benefit, as may exist for those that are deemed eligible and allowed to proceed with participation in the specific research study. Although the institutional bodies overseeing conduct of clinical research strive to ensure an ongoing scrutiny and prioritization of participants' wellbeing, we perceive that these mechanisms fall short as regards the interests of those volunteers who are subsequently excluded from participation in clinical research of relevance. While provision of ancillary care to address health concerns that are unmasked during the screening process may be an optimal strategy, the likelihood of successfully implementing this latter concept in current times of fiscal constraints is slim to nonexistent. Through this submission, we hope to initiate a dialogue within the research community regarding whether the current paradigm of conduct of clinical research be modified to include some degree of consideration for the screened out. We herein propose that for those volunteering for disease/disorder specific clinical research, some added degree of benefit can be assured to the screened out population through the provision of targeted health education or counseling.
Sikandar, Shafaq; Patel, Ryan; Patel, Sital; Sikander, Sanam; Bennett, David L.H.; Dickenson, Anthony H.
This review selectively explores some areas of pain research that, until recently, have been poorly understood. We have chosen four topics that relate to clinical pain and we discuss the underlying mechanisms and related pathophysiologies contributing to these pain states. A key issue in pain medicine involves crucial events and mediators that contribute to normal and abnormal pain signaling, but remain unseen without genetic, biomarker or imaging analysis. Here we consider how the altered genetic make-up of familial pains reveals the human importance of channels discovered by preclinical research, followed by the contribution of receptors as stimulus transducers in cold sensing and cold pain. Finally we review recent data on the neuro-immune interactions in chronic pain and the potential targets for treatment in cancer-induced bone pain. PMID:23500200
Zeanah, Charles H.
The degree to which early adverse experiences exert long term effects on development and how much early adversity may be overcome through subsequent experiences are important mental health questions. The clinical, research and policy perspectives on these questions lead to different answers. From a clinical perspective, change is always possible,…
Senter, Katherine G; Sukumar, Sreenivas R; Patton, Robert M; Chaum, Ed
Diabetic retinopathy (DR) is a leading cause of blindness and common complication of diabetes. Many diabetic patients take antihypertensive drugs to prevent cardiovascular problems, but these drugs may have unintended consequences on eyesight. Six common classes of antihypertensive drug are angiotensin converting enzyme (ACE) inhibitors, alpha blockers, angiotensin receptor blockers (ARBs), -blockers, calcium channel blockers, and diuretics. Analysis of medical history data might indicate which of these drugs provide safe blood pressure control, and a literature review is often used to guide such analyses. Beyond manual reading of relevant publications, we sought to identify quantitative trends in literature from the biomedical database PubMed to compare with quantitative trends in the clinical data. By recording and analyzing PubMed search results, we found wide variation in the prevalence of each antihypertensive drug in DR literature. Drug classes developed more recently such as ACE inhibitors and ARBs were most prevalent. We also identified instances of change-over-time in publication patterns. We then compared these literature trends to a dataset of 500 diabetic patients from the UT Hamilton Eye Institute. Data for each patient included class of antihypertensive drug, presence and severity of DR. Graphical comparison revealed that older drug classes such as diuretics, calcium channel blockers, and -blockers were much more prevalent in the clinical data than in the DR and antihypertensive literature. Finally, quantitative analysis of the dataset revealed that patients taking -blockers were statistically more likely to have DR than patients taking other medications, controlling for presence of hypertension and year of diabetes onset. This finding was concerning given the prevalence of -blockers in the clinical data. We determined that clinical use of -blockers should be minimized in diabetic patients to prevent retinal damage.
... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Research and Development Officer through the Director of the Clinical Science Research and...
Ayers Lawrence, Lisa
The Dive and Discover Web site is a virtual treasure chest of deep sea science and classroom resources. The goals of Dive and Discover are to engage students, teachers, and the general public in the excitement of ocean disco very through an interactive educational Web site. You can follow scientists on oceanographic research cruises by reading their daily cruise logs, viewing photos and video clips of the discoveries, and even e-mailing questions to the scientists and crew. WHOI has also included an "Educator's Companion" section with teaching strategies, activities, and assessments, making Dive and Discover an excellent resource for the classroom.
Lawrence, Lisa Ayers
The Dive and Discover Web site is a virtual treasure chest of deep sea science and classroom resources. The goals of Dive and Discover are to engage students, teachers, and the general public in the excitement of ocean disco very through an interactive educational Web site. You can follow scientists on oceanographic research cruises by reading their daily cruise logs, viewing photos and video clips of the discoveries, and even e-mailing questions to the scientists and crew. WHOI has also included an “Educator's Companion” section with teaching strategies, activities, and assessments, making Dive and Discover an excellent resource for the classroom.
Kaye, Jane; Hurles, Matthew; Griffin, Heather; Grewal, Jasote; Bobrow, Martin; Timpson, Nic; Smee, Carol; Bolton, Patrick; Durbin, Richard; Dyke, Stephanie; Fitzpatrick, David; Kennedy, Karen; Kent, Alastair; Muddyman, Dawn; Muntoni, Francesco; Raymond, Lucy F; Semple, Robert; Spector, Tim
Recent advances in sequencing technology allow data on the human genome to be generated more quickly and in greater detail than ever before. Such detail includes findings that may be of significance to the health of the research participant involved. Although research studies generally do not feed back information on clinically significant findings (CSFs) to participants, this stance is increasingly being questioned. There may be difficulties and risks in feeding clinically significant information back to research participants, however, the UK10K consortium sought to address these by creating a detailed management pathway. This was not intended to create any obligation upon the researchers to feed back any CSFs they discovered. Instead, it provides a mechanism to ensure that any such findings can be passed on to the participant where appropriate. This paper describes this mechanism and the specific criteria, which must be fulfilled in order for a finding and participant to qualify for feedback. This mechanism could be used by future research consortia, and may also assist in the development of sound principles for dealing with CSFs.
Kaye, Jane; Hurles, Matthew; Griffin, Heather; Grewal, Jasote; Bobrow, Martin; Timpson, Nic; Smee, Carol; Bolton, Patrick; Durbin, Richard; Dyke, Stephanie; Fitzpatrick, David; Kennedy, Karen; Kent, Alastair; Muddyman, Dawn; Muntoni, Francesco; Raymond, Lucy F; Semple, Robert; Spector, Tim
Recent advances in sequencing technology allow data on the human genome to be generated more quickly and in greater detail than ever before. Such detail includes findings that may be of significance to the health of the research participant involved. Although research studies generally do not feed back information on clinically significant findings (CSFs) to participants, this stance is increasingly being questioned. There may be difficulties and risks in feeding clinically significant information back to research participants, however, the UK10K consortium sought to address these by creating a detailed management pathway. This was not intended to create any obligation upon the researchers to feed back any CSFs they discovered. Instead, it provides a mechanism to ensure that any such findings can be passed on to the participant where appropriate. This paper describes this mechanism and the specific criteria, which must be fulfilled in order for a finding and participant to qualify for feedback. This mechanism could be used by future research consortia, and may also assist in the development of sound principles for dealing with CSFs. PMID:24424120
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.
Hoxha, Julia; Weng, Chunhua
The worldwide adoption of electronic health records (EHR) promises to accelerate clinical research, which lies at the heart of medical advances. However, the interrogation of such Big Data by clinical researchers can be laborious and error-prone, involving iterative and ineffective communication of data requests to data analysts. Research on this communication process is rare. There also exists no contemporary system that offers intelligent solutions to assist clinical researchers in their quest for clinical data. In this article, we first provide a detailed characterization of the challenges encountered in this communication space. Second, we identify promising synergies between fields studying human-to-human and human-machine communication that can shed light on biomedical data query mediation. We propose a mixed-initiative dialog-based approach to support autonomous clinical data access and recommend needed technology development and communication study for accelerating clinical research.
Wenner, Danielle M
In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is fundamentally grounded in the social value of knowledge, and that this value is context-dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings.
Moore, Frederick A.; Ziegler, Thomas R.; Heyland, Daren K.; Marik, Paul E.; Bistrian, Bruce R.
Most clinicians believe that nutrition support therapy improves outcome in hospitalized patients. Unfortunately, few patients receive optimal nutrition management. A lack of strong, well-designed research studies may prevent the medical/surgical community from fully embracing the practice. More quality research is needed. This article discusses 3 potential strategies to improve research activity in clinical nutrition: increase funding of nutrition research, foster young physician training in nutrition and research, and attract nutrition researchers to our national nutrition society meetings. The best chance for this process to succeed is for the national nutrition societies to partner with medical and surgical subspecialty societies to develop larger scale clinical and translational research programs. PMID:21149841
Oral health care products generally require laboratory or clinical testing prior to being introduced to the market. Companies that develop such products have three options for such testing--their own facilities, dental schools, or clinical research organizations (CROs). Laboratory or clinical trials involving subjects can be conducted to test claims of safety and efficacy as well as cosmetic and therapeutic claims. CROs, which conduct such research on a fee-for-service basis in an independent environment, are an attractive alternative in many cases.
Lyon, Gholson J.; Jiang, Tao; Van Wijk, Richard; Wang, Wei; Bodily, Paul Mark; Xing, Jinchuan; Tian, Lifeng; Robison, Reid J.; Clement, Mark; Lin, Yang; Zhang, Peng; Liu, Ying; Moore, Barry; Glessner, Joseph T.; Elia, Josephine; Reimherr, Fred; van Solinge, Wouter W.; Yandell, Mark; Hakonarson, Hakon; Wang, Jun; Johnson, William Evan; Wei, Zhi; Wang, Kai
Exome sequencing has identified the causes of several Mendelian diseases, although it has rarely been used in a clinical setting to diagnose the genetic cause of an idiopathic disorder in a single patient. We performed exome sequencing on a pedigree with several members affected with attention deficit/hyperactivity disorder (ADHD), in an effort to identify candidate variants predisposing to this complex disease. While we did identify some rare variants that might predispose to ADHD, we have not yet proven the causality for any of them. However, over the course of the study, one subject was discovered to have idiopathic hemolytic anemia (IHA), which was suspected to be genetic in origin. Analysis of this subject’s exome readily identified two rare non-synonymous mutations in PKLR gene as the most likely cause of the IHA, although these two mutations had not been documented before in a single individual. We further confirmed the deficiency by functional biochemical testing, consistent with a diagnosis of red blood cell pyruvate kinase deficiency. Our study implies that exome and genome sequencing will certainly reveal additional rare variation causative for even well-studied classical Mendelian diseases, while also revealing variants that might play a role in complex diseases. Furthermore, our study has clinical and ethical implications for exome and genome sequencing in a research setting; how to handle unrelated findings of clinical significance, in the context of originally planned complex disease research, remains a largely uncharted area for clinicians and researchers. PMID:21794208
Liu, Jessica A; Hagerman, Randi J; Miller, Robert M; Craft, Lisa T; Finucane, Brenda; Tartaglia, Nicole; Berry-Kravis, Elizabeth M; Sherman, Stephanie L; Kidd, Sharon A; Cohen, Jeffrey
The objectives of the study were to assess the attitudes and experiences of clinicians involved in a consortium of clinics serving people with fragile X-associated disorders to gauge satisfaction with the consortium and its efforts to improve quality of life for patients and the community. An internet survey was sent to 26 fragile X (FX) clinic directors participating in the Fragile X Clinical and Research Consortium (FXCRC). Respondents were asked to complete 19 questions on consortium performance and outcomes relevant for their own clinic. The response rate was 84% (22/26), with two surveys providing incomplete data. Assistance with clinic establishment, opportunities for research collaborations, and access to colleagues and information were highly valued. Approximately 76% of clinicians reported improvements in patient care and 60% reported an increase in patient services. There was a 57% increase in participation in a FX-related clinical trial among clinics since joining the FXCRC (24% vs. 81%). Overall, respondents reported primarily positive experiences from participation in the FXCRC. Common suggestions for improvement included additional financial support and increased utilization of collected patient data for research purposes. Additionally, a Clinic Services Checklist was administered annually to examine changes in services offered over time. There were several important changes regarding the provision of services by clinics, often with multiple clinics changing with respect to a service. In conclusion, the FXCRC has led to the establishment and sustainment of fragile X clinics in the U.S., fostered cooperation among fragile X clinicians, and provided clinics with a platform to share recommendations and best practices to maximize quality of life for their patients and the overall fragile X community. The results from the survey and checklist also provide suggestions to strengthen the FXCRC and enhance future collaborations among FXCRC members. © 2016
Refolo, P; Sacchini, D; Minacori, R; Daloiso, V; Spagnolo, A G
Patient recruitment is a critical point of today's clinical research. Several proposals have been made for improving it, but the effectiveness of these measures is actually uncertain. The use of Internet (e-recruitment) could represent a great chance to improve patient enrolment, even though the effectiveness of this implementation is not so evident. E-recruitment could bring some advantages, such as better interaction between clinical research demand and clinical research supply, time and resources optimization, and reduction of data entry errors. It raises some issues too, such as sampling errors, validity of informed consent, and protection of privacy. Research Ethics Committees/Institutional Review Boards should consider these critical points. The paper deals with Internet recruitment for clinical research. It also attempts to provide Research Ethics Committees/Institutional Review Boards with notes for assessing e-recruitment based clinical protocols.
Sparked by the Institute of Medicine's report titled Crossing the Quality Chasm, research-based decision making has been emphasized for improving care. Patients should receive care that is based on the best available scientific knowledge, and care should not vary from clinician to clinician or from place to place. Implementing research-based practices at the bedside is a complex endeavor. It is all too easy to discover that clinically important research findings are either not known by practitioners or not being used in actual practice. Efforts to instill and sustain research-based practices improve significantly when staff nurses are involved with the research from the start. Institutions that are effective in involving clinicians have built a foundation of infrastructures that enable processes for engaging clinicians to take place. What distinguishes effective from ineffective hospital nursing research and evidence-based practice programs is the presence of structures whereby processes can occur that (1) unleash the creativity of staff by securing their involvement early, (2) educate staff by involving them, (3) create internal expertise for research and evidence-based practice, and (4) ensure that patients experience principled implementation of research-based practices to improve their lives. This article describes infrastructures that can ensure and sustain research-based practices while unleashing the talent and creativity of clinicians as they question practice and ponder the merits of current research. Fostering participation in such clinical inquiry will summon professional growth, influence the lives of patients, and help each nurse develop a unique personal professional legacy.
Siegfried, Nandi; Johnson, Quinton
Abstract An electronic survey was used to assess the training needs of clinical and public health researchers who have been involved, and/or plan to become involved, in clinical trials of herbal medicines in Africa. Over 90 researchers were contacted through pre-existing networks, of whom 58 (64%) responded, from 35 institutions in 14 African countries. Over half (57%) had already been involved in a clinical trial of an herbal medicine, and gave information about a total of 23 trials that have already been completed. Of these, only five had been published, and only one had resulted in a licensed product. Fifty-four (54) of the researchers were planning to conduct a clinical trial of an herbal medicine in the future, and gave information about 54 possible trials. Respondents outlined the following most commonly encountered difficulties when conducting clinical trials: resource constraints (including lack of funding, equipment, staff, and infrastructure); social acceptance of the clinical trial (including difficulty recruiting enough patients, poor rapport with traditional healers, and willingness of biomedical staff to be involved); herbal medicine supply (including insufficient cultivation, production, and quality control); lack of trained staff; and logistical issues in conducting trials. The topics in which researchers were least confident were Intellectual Property Rights issues, statistical issues, and issues related to Good Clinical Practice guidelines. PMID:22784350
Rubio, Doris McGartland
The Clinical and Translational Science Award (CTSA) program was designed by the National Institutes of Health (NIH) to develop processes and infrastructure for clinical and translational research throughout the United States. The CTSA initiative now funds 61 institutions. In 2012, the National Center for Advancing Translational Sciences, which administers the CTSA Program, charged the Evaluation Key Function Committee of the CTSA Consortium to develop common metrics to assess the efficiency of clinical research processes and outcomes. At this writing, the committee has identified 15 metrics in six categories. It has also developed a standardized protocol to define, pilot test, refine, and implement the metrics. The ultimate goal is to learn critical lessons about how to evaluate the processes and outcomes of clinical research within the CTSAs and beyond. This article describes the work involved in developing and applying common metrics and benchmarks of evaluation.
Kalbaugh, Corey A.
Although extensive research addresses minorities’ low participation in clinical research, most focuses almost exclusively on therapeutic trials. The existing literature might mask important issues concerning minorities’ participation in clinical trials, and minorities might actually be overrepresented in phase I safety studies that require the participation of healthy volunteers. It is critical to consider the entire spectrum of clinical research when discussing the participation of disenfranchised groups; the literature on minorities’ distrust, poor access, and other barriers to trial participation needs reexamination. Minority participation in clinical trials is an important topic in public health discussions because this representation touches on issues of equality and the elimination of disparities, which are core values of the field. PMID:22021285
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).
“Once development was ended…in the adult centers, the nerve paths are something fixed and immutable. Everything may die, nothing may be regenerated,” wrote Santiago Ramón y Cajal, a Spanish neuroanatomist and Nobel Prize winner and the father of modern neuroscience. This statement was the central dogma in neuroscience for a long time. However, in the 1960s, neural stem cells (NSCs) were discovered. Since then, our knowledge about NSCs has continued to grow. This review focuses on our current knowledge about NSCs and their surrounding microenvironment. In addition, the clinical application of NSCs for the treatment of various central nervous system diseases is also summarized. PMID:26888043
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 ClinicalTrials.gov data for information and commentary on projections, progress, and impediments associated with clinical trials in India. We also propose targeted solutions to identified challenges. The Indian clinical trial sector grew by (+) 20.3% CAGR (compound annual growth rate) between 2005 and 2010 and contracted by (-) 14.6% CAGR between 2010 and 2013. Phase-1 trials grew by (+) 43.5% CAGR from 2005–2013, phase-2 trials grew by (+) 19.8% CAGR from 2005–2009 and contracted by (-) 12.6% CAGR from 2009–2013, and phase-3 trials grew by (+) 13.0% CAGR from 2005–2010 and contracted by (-) 28.8% CAGR from 2010–2013. This was associated with a slowing of the regulatory approval process, increased media coverage and activist engagement, and accelerated development of regulatory guidelines and recuperative initiatives. We propose the following as potential targets for restorative interventions: Regulatory overhaul (leadership and enforcement of regulations, resolution of ambiguity in regulations, staffing, training, guidelines, and ethical principles [e.g., compensation]).Education and training of research professionals, clinicians, and regulators.Public awareness and empowerment. After a peak in 2009-2010, the clinical research sector in India appears to be experiencing a contraction. There are indications of challenges in regulatory enforcement of guidelines; training of clinical research professionals; and awareness, participation, partnership, and the general image amongst the non-professional media and public. Preventative and corrective principles and interventions are outlined with the goal of realizing the clinical research potential in India. PMID:25590017
Nussbaumer, Harry; Bieri, Lydia; Sandage, Foreword by Allan
Acknowledgments; Foreword; 1. Introduction; 2. Cosmological concepts at the end of the Middle Ages; 3. Nebulae as a new astronomical phenomenon; 4. On the construction of the Heavens; 5. Island universes turn into astronomical facts: a universe of galaxies; 6. The early cosmology of Einstein and de Sitter; 7. The dynamical universe of Friedmann; 8. Redshifts: how to reconcile Slipher and de Sitter?; 9. Lemaître discovers the expanding universe; 10. Hubble's contribution of 1929; 11. The breakthrough for the expanding universe; 12. Hubble's anger about de Sitter; 13. Robertson and Tolman join the game; 14. The Einstein-de Sitter universe; 15. Are Sun and Earth older than the universe?; 16. In search of alternative tracks; 17. The seed for the Big Bang; 18. Summary and Postscript; Appendix; References; Index.
A West Virginia high-school student has discovered a new pulsar, using data from the giant Robert C. Byrd Green Bank Telescope (GBT). Shay Bloxton, 15, a participant in a project in which students analyze data from the radio telescope, spotted evidence of the pulsar on October 15. Bloxton, along with NRAO astronomers observed the object again one month later. The new observation confirmed that the object is a pulsar, a rotating, superdense neutron star. Bloxton is a sophomore at Nicholas County High School in Summersville, West Virginia. "I was very excited when I found out I had actually made a discovery," Bloxton said. She went to Green Bank in November to participate in the follow-up observation. She termed that visit "a great experience." "It also helped me learn a lot about how observations with the GBT are actually done," she added. The project in which she participated, called the Pulsar Search Collaboratory (PSC), is a joint project of the National Radio Astronomy Observatory (NRAO) and West Virginia University, funded by a grant from the National Science Foundation. Pulsars are known for their lighthouse-like beams of radio waves that sweep through space as the neutron star rotates, creating a pulse as the beam sweeps by the Earth. First discovered in 1967, pulsars serve as valuable natural "laboratories" for physicists studying exotic states of matter, quantum mechanics and General Relativity. The GBT, dedicated in 2000, has become one of the world's leading tools for discovering and studying pulsars. The PSC, led by NRAO Education Officer Sue Ann Heatherly and Project Director Rachel Rosen, includes training for teachers and student leaders, and provides parcels of data from the GBT to student teams. The project involves teachers and students in helping astronomers analyze data from 1500 hours of observing with the GBT. The 120 terabytes of data were produced by 70,000 individual pointings of the giant, 17-million-pound telescope. Some 300 hours of the
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.
This paper introduces taxonomy of clinical uncertaintes and argues that the choice of scientific method should match the underlying level of uncertainty. Clinical trial is one of these methods aiming to resolve clinical uncertainties. Whenever possible these uncertainties should be quantified. The paper further shows that the still ongoing debate about the usage of "equipoise" vs. "uncertainty principle" vs. "indifference" as an entry criterion to clinical trials actually refers to the question "whose uncertainty counts". This question is intimately linked to the control of research agenda, which is not quantifiable and hence is not solvable to equal acceptability to all interested parties. The author finally shows that there is a predictable relation between [acknowledgement of] uncertainty (the moral principle) on which trials are based and the ultimate outcomes of clinical trials. That is, [acknowledgement of] uncertainty determines a pattern of success in medicine and drives clinical discoveries.
Brubaker, Linda; Kenton, Kimberly
Research education is a requirement for obstetrics and gynecology residents. Most obstetrics and gynecology residencies struggle with barriers to efficient, effective research education and productivity for their residents. These barriers include constraints on faculty time, lack of intrinsic desire within individual residents, and lack of relevant outcome measures. We developed an efficient, novel research education curriculum that overcomes many of these barriers and provides obstetrics and gynecology residents with a structured format that maximizes the likelihood of a successful, positive research experience. Since the start of the Clinical Research Education Study Team program, the graduating resident cohorts reliably complete and present prospective research projects, including three registered randomized trials. Residency-wide support for other team research has grown dramatically. The residents' work was acknowledged with several research awards, which further reinforces the positive perception of the program. The certainty of completion of their research requirement relieved our residents of the anxiety commonly reported by residents nearing graduation. The Clinical Research Education Study Team program's team design makes efficient use of faculty time. In addition, Clinical Research Education Study Team mentors also have incorporated junior faculty members who wish to improve their own research education skills. We offer our experience with this program in hopes that it may be of value to other programs that wish to improve their resident research education curriculum. It remains important for residents to acquire research skills before continuing into practice or fellowship. The Clinical Research Education Study Team program facilitates this education in an efficient, organized manner.
Lynch, David R; Pandolfo, Massimo; Schulz, Jorg B; Perlman, Susan; Delatycki, Martin B; Payne, R Mark; Shaddy, Robert; Fischbeck, Kenneth H; Farmer, Jennifer; Kantor, Paul; Raman, Subha V; Hunegs, Lisa; Odenkirchen, Joanne; Miller, Kristy; Kaufmann, Petra
To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements, which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich's ataxia (FRDA), a neurological disorder that involves multiple organ systems. To develop FRDA common data elements, FRDA experts formed a working group and subgroups to define elements in the following: ataxia and performance measures; biomarkers; cardiac and other clinical outcomes; and demographics, laboratory tests, and medical history. The basic development process included identification of international experts in FRDA clinical research, meeting by teleconference to develop a draft of standardized common data elements recommendations, vetting of recommendations across the subgroups, and dissemination of recommendations to the research community for public comment. The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The subgroups' recommendations are classified as core, supplemental, or exploratory. Template case report forms were created for many of the core tests. The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new, ongoing studies will be assessed in an ongoing fashion to define their utility in FRDA.
Anderson, H. Vernon; Weintraub, William S.; Radford, Martha J.; Kremers, Mark S.; Roe, Matthew T.; Shaw, Richard E.; Pinchotti, Dana M.; Tcheng, James E.
Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nevertheless these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the two major technical standards organizations in healthcare, the Clinical Data Interchange Standards Consortium and Health Level 7 International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care. PMID
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 < .0001), and multidisciplinary team (69.9% vs 87%; P = .003) was observed. In terms of specific study design, a significant decline in case reports (34.3% vs 10.3%; P < .0001) and an increase in case-control studies (11.3% vs 22.9%; P = .02) were evident over the 10-year interval. This comparative audit revealed that there has been a discernible change in the methodology profile of clinical research in child neurology over a decade. Trends apparently suggest a more rigorous approach to study design and investigation in this field.
Davis, James; Anderson, Maggie; Stankevitz, Kristen
Undergraduate premedical students face a prodigious decision as they work to determine whether to pursue a profession in medicine. Experience in clinical medicine and research is essential to inform students what it might be like to be a physician. Undergraduates, however, face a number of obstacles to obtaining the kind of quality clinical and research experience needed to best inform them on this decision. Growing regulations designed to protect patient confidentiality, though undeniably important, pose a barrier to students seeking patient contact. Traditional passive physician shadowing often does not provide ample opportunities for one-on-one patient interaction or problem solving. Finally, research opportunities available to students typically are not associated with clinical work and therefore do not provide an experiential model of how empirical evidence informs medical practice. This report provides a description of the University of Wisconsin Tobacco Science Scholars Program, a pilot program designed to grapple with some of these barriers. The program provides supervision for students so that they might fulfill institutional requirements required for patient contact, provides an active model of clinical patient interaction and problem solving, and provides access to research that is integrated into the student’s clinical experience so the student might better understand the nature of research-based evidence in medicine. Program details and limitations are discussed. PMID:24734413
Shoffner, Michael; Owen, Phillips; Mostafa, Javed; Lamm, Brent; Wang, Xiaoshu; Schmitt, Charles P.; Ahalt, Stanley C.
Clinical data has tremendous value for translational research, but only if security and privacy concerns can be addressed satisfactorily. A collaboration of clinical and informatics teams, including RENCI, NC TraCS, UNC’s School of Information and Library Science, Information Technology Service’s Research Computing and other partners at the University of North Carolina at Chapel Hill have developed a system called the Secure Medical Research Workspace (SMRW) that enables researchers to use clinical data securely for research. SMRW significantly minimizes the risk presented when using of identified clinical data, thereby protecting patients, researchers, and institutions associated with the data. The SMRW is built on a novel combination of virtualization and data leakage protection and can be combined with other protection methodologies and scaled to production levels. PMID:23751029
Wong, C; Chen, A A; Behr, B; Shen, S
Mammalian preimplantation embryo development is a complex process in which the exact timing and sequence of events are as essential as the accurate execution of the events themselves. Time-lapse microscopy (TLM) is an ideal tool to study this process since the ability to capture images over time provides a combination of morphological, dynamic and quantitative information about developmental events. Here, we systematically review the application of TLM in basic and clinical embryo research. We identified all relevant preimplantation embryo TLM studies published in English up to May 2012 using PubMed and Google Scholar. We then analysed the technical challenges involved in embryo TLM studies and how these challenges may be overcome with technological innovations. Finally, we reviewed the different types of TLM embryo studies, with a special focus on how TLM can benefit clinical assisted reproduction. Although new parameters predictive of embryo development potential may be discovered and used clinically to potentially increase the success rate of IVF, adopting TLM to routine clinical practice will require innovations in both optics and image analysis. Combined with such innovations, TLM may provide embryologists and clinicians with an important tool for making critical decisions in assisted reproduction. In this review, we perform a literature search of all published early embryo development studies that used time-lapse microscopy (TLM). From the literature, we discuss the benefits of TLM over traditional time-point analysis, as well as the technical difficulties and solutions involved in implementing TLM for embryo studies. We further discuss research that has successfully derived non-invasive markers that may increase the success rate of assisted reproductive technologies, primarily IVF. Most notably, we extend our discussion to highlight important considerations for the practical use of TLM in research and clinical settings.
Cotts, Timothy; Khairy, Paul; Opotowsky, Alexander R.; John, Anitha S.; Valente, Anne Marie; Zaidi, Ali N.; Cook, Stephen C.; Aboulhosn, Jamil; Ting, Jennifer Grando; Gurvitz, Michelle; Landzberg, Michael J.; Verstappen, Amy; Kay, Joseph; Earing, Michael; Franklin, Wayne; Kogon, Brian; Broberg, Craig S.
Background Adult congenital heart disease (ACHD) clinicians are hampered by the paucity of data to inform clinical decision-making. The objective of this study was to identify priorities for clinical research in ACHD. Methods A list of 45 research questions was developed by the Alliance for Adult Research in Congenital Cardiology (AARCC), compiled into a survey, and administered to ACHD providers. Patient input was sought via the Adult Congenital Heart Association at community meetings and online forums. The 25 top questions were sent to ACHD providers worldwide via an online survey. Each question was ranked based on perceived priority and weighted based on time spent in ACHD care. The top 10 topics identified are presented and discussed. Results The final online survey yielded 139 responses. Top priority questions related to tetralogy of Fallot (timing of pulmonary valve replacement and criteria for primary prevention ICDs), patients with systemic right ventricles (determining the optimal echocardiographic techniques for measuring right ventricular function, and indications for tricuspid valve replacement and primary prevention ICDs), and single ventricle/Fontan patients (role of pulmonary vasodilators, optimal anticoagulation, medical therapy for preservation of ventricular function, treatment for protein losing enteropathy). In addition, establishing criteria to refer ACHD patients for cardiac transplantation was deemed a priority. Conclusions The ACHD field is in need of prospective research to address fundamental clinical questions. It is hoped that this methodical consultation process will inform researchers and funding organizations about clinical research topics deemed to be of high priority. PMID:24411207
Our increased interest in translational research has created a large demand for blood, tissue and other clinical samples, which find use in a broad variety of research including genomics, proteomics, and metabolomics. Hundreds of millions of dollars have been invested internationally on the collection, storage and distribution of samples. Nevertheless, many researchers complain in frustration about their inability to obtain relevant and/or useful samples for their research. Lack of access to samples, poor condition of samples, and unavailability of appropriate control samples have slowed our progress in the study of diseases and biomarkers. In this editorial, I focus on five major challenges that thwart clinical sample use for translational research and propose near term objectives to address them. They include: (1) defining our biobanking needs; (2) increasing the use of and access to standard operating procedures; (3) mapping inter-observer differences for use in normalizing diagnoses; (4) identifying natural internal protein controls; and (5) redefining the clinical sample paradigm by building partnerships with the public. In each case, I believe that we have the tools at hand required to achieve the objective within 5 years. Potential paths to achieve these objectives are explored. However we solve these problems, the future of proteomics depends on access to high quality clinical samples, collected under standardized conditions, accurately annotated and shared under conditions that promote the research we need to do. PMID:22998582
... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Committee advises the Chief Research and Development Officer through the Director of the Clinical...
... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...
... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...
Lazarus, Gerald S; Kirsner, Robert S; Zenilman, Jonathan; Valle, M Frances; Margolis, David J; Cullum, Nicky; Driver, Vickie R; Gould, Lisa; Lindsay, Ellie; Tunis, Sean; Marston, William; Bass, Eric; Ennis, William; Davidson, Jeffrey; Bowden, Jeremy
The present status of clinical leg ulcer healing research was reviewed by 25 experts over 2 days on September 28 and 29, 2015. Multiple clinical effectiveness reviews were presented suggesting that published clinical wound healing research often does not meet present (2015) evidence based standards. Specific areas requiring remediation were highlighted and approaches to overcoming existing challenges were proposed. Participants using anonymous voting technology developed an action plan to resolve perceived deficiencies. Statements were accepted if 75% of participants agreed. Older patients with a high frequency of comorbid conditions posed particular difficulties in designing clinical research protocols and better diagnostic categorization is necessary A standardized model template for collecting information about diagnosis and evaluation of the effect of interventions on healing of all types of leg ulcers was considered a high priority. Such a model template could be modified depending on the specific etiology of the leg ulcers. Generally agreed on quantifiable standards to establish degree of morbidity was considered a high priority. There was universal agreement that sources of funding and conflicts of interest needed to be disclosed in presentations and all publications. All clinical research studies should be registered with appropriate authorities. There was substantial enthusiasm for a clinical research network with quality standards for membership and an advisory research core available to investigators. Such a network should be funded and actively managed to insure long-term viability. The governance of such an entity needs to be established by the wound care community. The present trend to integrate patients into the clinical research process was endorsed and there was enthusiasm to develop patient advocacy for wound healing research.
Allen, D. G.
Echocardiography is the accepted term for the study of cardiac ultrasound. Although a relatively new tool for the study of the heart in man it has already found wide acceptance in the area of cardiac research and in the study of clinical cardiac disease. Animals had often been used in the early experiments with cardiac ultrasound, but only recently has echocardiography been used as a research and clinical tool in veterinary medicine. In this report echocardiography is used in the research of anesthetic effects on ventricular function and clinically in the diagnosis of congestive cardiomyopathy in a cat, ventricular septal defect in a calf, and pericardial effusion in a dog. Echocardiography is now an important adjunct to the field of veterinary cardiology. ImagesFigure 7.Figure 8.Figure 9.Figure 10. PMID:17422196
Nagin, Daniel S; Odgers, Candice L
Group-based trajectory models are increasingly being applied in clinical research to map the developmental course of symptoms and assess heterogeneity in response to clinical interventions. In this review, we provide a nontechnical overview of group-based trajectory and growth mixture modeling alongside a sampling of how these models have been applied in clinical research. We discuss the challenges associated with the application of both types of group-based models and propose a set of preliminary guidelines for applied researchers to follow when reporting model results. Future directions in group-based modeling applications are discussed, including the use of trajectory models to facilitate causal inference when random assignment to treatment condition is not possible.
Wadlund, Jill; Platt, Leslie A
Scientific discovery and knowledge expansion in the post genome era holds great promise for new medical technologies and cellular-based therapies with multiple applications that will save and enhance lives. While human beings long have hoped to unlock the mysteries of the molecular basis of life; our society is now on the verge of doing so. But new scientific and technological breakthroughs often come with some risks attached. Research--especially clinical trials and research involving human participants--must be conducted in accordance with the highest ethical and scientific principles. Yet, as the number and complexity of clinical trials increase, so do pressures for new revenue sources and shorter product development cycles, which could have an adverse impact on patient safety. This article explores the use of risk management tools in clinical research.
Schulz, Richard; O’Brien, Alison; Czaja, Sara; Ory, Marcia; Norris, Rachel; Martire, Lynn M.; Belle, Steven H.; Burgio, Lou; Gitlin, Laura; Coon, David; Burns, Robert; Gallagher-Thompson, Dolores; Stevens, Alan
Purpose We reviewed intervention studies that reported dementia caregiver outcomes published since 1996, including psychosocial interventions for caregivers and environmental and pharmacological interventions for care recipients. Our goal was to focus on issues of clinical significance in caregiver intervention research in order to move the field toward a greater emphasis on achieving reliable and clinically meaningful outcomes. Design and Methods MEDLINE, PsycINFO, and Cumulative Index to Nursing & Allied Health databases from 1996 through 2001 were searched to identify articles and book chapters mapping to two medical subject headings: caregivers and either dementia or Alzheimer’s disease. Articles were evaluated on two dimensions, outcomes in four domains thought to be important to the individual or society and the magnitude of reported effects for these outcomes in order to determine if they were large enough to be clinically meaningful. Results Although many studies have reported small to moderate statistically significant effects on a broad range of outcomes, only a small proportion of these studies achieved clinically meaningful outcomes. Nevertheless, caregiving intervention studies have increasingly shown promise of affecting important public health outcomes in areas such as service utilization, including delayed institutionalization; psychiatric symptomatology, including the successful treatment of major and minor depression; and providing services that are highly valued by caregivers. Implications Assessment of clinical significance in addition to statistical significance is needed in this research area. Specific recommendations on design, measurement, and conceptual issues are made to enhance the clinical significance of future research. PMID:12351794
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.
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.
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.
Bhave, Amita; Menon, Suresh
In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest.
Bhave, Amita; Menon, Suresh
In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest. PMID:28194332
Straight, Timothy M
The system in place to ensure the ethical conduct of human subject research in accordance with federal regulations has drawn great criticism from all sides, to include clinical investigators, administrators, research subjects, and legislators. The administrative requirements associated with clinical trials has changed dramatically in the last several decades, as has the complexity of the science being regulated. The institutional review board (IRB) system, however, appears to be struggling to keep pace, and has even been labeled a "system in jeopardy" by a national committee of experts. This contribution outlines the current obstacles and critique of IRBs, providing a discussion of the structure of the IRB system and strategies to meet these challenges.
Sayed, Suhail I; Dutta, Sourav; Mateen, Sayyad; Kazi, Rehan; Jagade, Mohan
A vibrant health research industry is an indispensible asset for societal development. Health research focus and output in India is sadly not at par with the magnitude and distribution of the prevalent disease burden. In the current scenario of the ever evolving Indian public health sector, the balancing of research efforts between different competing fields, especially when resources are meagre, is a delicate one and quite typical of the problems anticipated in developing countries. To progress, the nation's clinical health research needs good quality, authentic and relevant research in the varied aspect of public health. Rhetoric or theoretical concepts alone cannot move the health status and research forward in this country. Evidence and evidence based medicine have revitalised the academic aspects of the public health sector. But, its up to the Indian policy makers, administrators and medical professionals to assure that the vast research opportunity this country offers is exploited to its maximum potential.
Gasior, Izabela; Solari, Jessica; Young, Vanessa; Bode, Justine; Herdes, Rachel E; Chung, Michelle
The Anesthesia Clinical Research Unit (ACRU) at Boston Children's Hospital developed the integrated clinical research team model in 2009 as a framework to support the high ethical standards and team-based approach in pediatric anesthesia research which was already established within the department. The foundation of the model is built on interdisciplinary collaboration, communication, and integrity in the field of clinical research. Above all, the work of the ACRU is focused on the patients, families and community as a whole. In order to uphold these standards, each member of the ACRU has a clearly-defined role while still promoting the core fundamentals of teamwork and continuity of care. This department-wide, team-based approach to clinical research has proven to be effective in its resourcefulness and productivity in running numerous large projects concurrently within the department.
COOKINGHAM, FRANK; WARD, TED W.
A CASE IS MADE FOR CLINICAL RESEARCH AS A 2-WAY STREET BETWEEN EDUCATIONAL RESEARCH AND PRACTICE. EDUCATIONAL RESEARCH IS DEFINED AS "THE DEVELOPMENT OF APPROPRIATE TECHNIQUES FOR THE MANAGEMENT OF THE LEARNING PROCESS IN AN EDUCATIONAL SETTING," THUS QUESTIONING THE RELEVANCY OF "BASIC" VS. "APPLIED" THEORIES.…
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…
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.
Lasalle, Bernie; Varner, Michael; Botkin, Jeff; Jackson, Marc; Stark, Louisa; Cessna, Melissa; Orthner, Carolyn; Hulse, Nathan; Bernasconi, Aldo; Madsen, Randy; Schultz, Dustin; Bradshaw, Richard; Mitchell, Joyce
The University of Utah Health Sciences (UUHSC) and Intermountain Healthcare (IH) support high value clinical and translational research programs. The Utah Biohealth Initiative will facilitate next generation research by leveraging the combined resources of both institutions through an infrastructure which links biospecimens and electronic health records (EHR). During phase I of the Utah BioHealth Initiative (UBI) the participating institutions developed a legal, regulatory and information technology infrastructure that supports clinical and translational research, and advances our understanding of health and disease, improves healthcare value and health for current and future generations of Utahns. We used the Federated Utah Research and Translational Health electronic Repository (FURTHeR) 1 to combine EHR and biospecimen data from an actual study populated by both institutions to demonstrate the robustness of the infrastructure.
Sosa Martínez, J; Deister Mateos, E
The collegiate and university realms--which include lectures, students, clinical and scientific sessions--is open to growth. Furthermore, it has opened gates for new currents of thought and planted hopes for the growth and development of professors who, apart from mastering their specialty, may be familiar with didactics and directly or indirectly engage in full-time research, so that their lecturing and promotions may partially depend on the number and quality of their published works, preferably on scientific research.
Kost, Rhonda G.; Lee, Laura N.; Yessis, Jennifer M.; Wesley, Robert; Alfano, Sandra; Alexander, Steven R.; Kassis, Sylvia Baedorf; Cola, Phil; Dozier, Ann; Ford, Dan E.; Harris, Paul; Kim, Emmelyn; Lee, Simon Craddock; O’Riordan, Gerri; Roth, Mary-Tara; Schuff, Kathryn; Wasser, June; Henderson, David K.; Coller, Barry S.
Background Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants’ experiences. To address this, we developed and deployed a survey at 15 NIH-supported clinical research centers to assess participant-centered outcomes; we report responses from 4,961 participants. Methods Survey questions addressed core aspects of the research participants’ experience, including their overall rating, motivation, trust, and informed consent. We describe participant characteristics, responses to individual questions, and correlations among responses. Results Respondents broadly represented the research population in sex, race, and ethnicity. Seventy-three percent awarded top ratings to their overall research experience and 94% reported no pressure to enroll. Top ratings correlated with feeling treated with respect, listened to, and having access to the research team (R2=0.80 - 0.96). White participants trusted researchers (88%) than did non-white participants collectively (80%) (p<0.0001). Many participants felt fully prepared by the informed consent process (67%) and wanted to receive research results (72%). Conclusions Our survey demonstrates that a majority of participants at NIH-supported clinical research centers rate their research experience very positively and that participant-centered outcome measures identify actionable items for improvement of participant’s experiences, research protections, and the conduct of clinical investigation. PMID:24842076
Dzudie, Anastase; Aminde, Leopold; Ngowe Ngowe, Marcelin; Takah, Noah; Luma, Henry Namme; Doualla, Marie Solange; Mapoure, Yacouba; Mbatchou, Hugo; Njamen, Theophile Nana; Priso, Eugene Belley; Kengne, Andre Pascal; Sliwa-Hahnle, Karen; Nkwescheu, Armand S; Sone, Albert Mouelle
There is a huge need for health research to support contextually relevant health service and policy solutions to better the health of populations in sub-Saharan Africa. This need contrasts with the very timid engagement of healthcare practitioners in research in the region.It is against this background that the Douala General Hospital (a tertiary-care hospital in Cameroon), under the stewardship of its chief executive officer, organised the first annual scientific and research day in October 2014. This maiden event saw the participation of local research leaders and the eminent director of the South African Hatter Institute for Cardiovascular Research in Africa, who co-chaired the event. The aim was to educate students, clinicians and junior researchers on the importance of clinical research and evidence-based medicine around the leading theme of the event: action for clinical research and good medical practice.Several abstracts were presented, covering various aspects of medicine, including cardiology, rheumatology, paediatrics, pulmonology, HIV medicine, and obstetrics and gynaecology, together with key lectures on cardiac disease and pregnancy, and plenary sessions on research methodology, scientific writing and publishing. It is hoped that this event will enhance clinical research and the dissemination of research findings to improve evidence-based clinical practice in the country.
Background 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. Methods 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. Results 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. Conclusions 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. PMID:24479414
Yu, Yong-qiang; Huang, Dong-yan; Armijo Olivo, Susan; Yang, Huai-an; Bambanini, Yagesh; Sonnenberg, Lyn; Clark, Brenda; Constantinescu, Gabriela; Qian Yu, Jason; Zhang, Ming
Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research's conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research's design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research's design in which appropriate methods have been applied to prevent this effect.They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect.
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.
Edwards, Sarah J L; Wilson, James
Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons. First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be practicable for regulators to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision-makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk-benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize.
Chadwick, R G
Photogrammetry is the art, science and technology of obtaining reliable information about physical objects through processes of recording and interpreting photographic images. This review outlines the principles of the technique and summarizes the various methodologies and applications in clinical dental research.
Cohen, Dorothy B; Frawley, Sandra J; Shifman, Mark A; Miller, Perry L; Brandt, Cynthia
We devised an algorithm for integrating similar clinical research data collection instruments to create a common measurement instrument. We tested this algorithm using questions from several similar surveys. We encountered differing levels of granularity among questions and responses across surveys resulting in either the loss of granularity or data. This algorithm may make survey integration more systematic and efficient.
The purpose of this notice is to notify the community that the National Cancer Institute's (NCI’s) Office of Cancer Clinical Proteomics Research (OCCPR) is seeking sources to establish a Biospecimen Core Resource (BCR), capable of receiving, qualifying, processing, and distributing annotated biospecimens.
Pelayo, Stephanie L.
This paper reviews the literature on the subject of forgiveness and suggests clinical implications for the treatment of adolescent offenders. Although research has been done in the areas of forgiveness, no studies have been conducted with adolescent offenders. This dearth of information points to a gap in understanding the role of forgiveness in…
A new funding opportunity in support of the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) seeks to prospectively procure tumor samples, collected for proteomics investigation. This procurement is being solicited for award by SAIC-F under its contract #HHSN261200800001E for Operations and Technical support at the Frederick National Laboratory for Cancer Research.
In a recently published manuscript in the journal of Molecular and Cellular Proteomics, researchers from the National Cancer Institutes (NCI) Clinical Proteomic Tumor Analysis Consortium (CPTAC) investigated the effect of cold ischemia on the proteome of fresh frozen tumors.
... No: 2012-12522] DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service... Science Research and Development Service Cooperative Studies Scientific Evaluation Committee will be held... Research and Development Officer through the Director of the Clinical Science Research and...
Laurencot, Carolyn M; Ruppel, Sheryl
Gene therapy products are highly regulated, therefore moving a promising candidate from the laboratory into the clinic can present unique challenges. Success can only be achieved by proper planning and communication within the clinical development team, as well as consultation with the regulatory scientists who will eventually review the clinical plan. Regulators should not be considered as obstacles but rather as collaborators whose advice can significantly expedite the product development. Sound scientific data is required and reviewed by the regulatory agencies to determine whether the potential benefit to the patient population outweighs the risk. Therefore, compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) principles to ensure quality, safety, purity, and potency of the product, and to establish "proof of concept" for efficacy, and for safety information, respectively, is essential. The design and conduct of the clinical trial must adhere to Good Clinical Practice (GCP) principals. The clinical protocol should contain adequate rationale, supported by nonclinical data, to justify the starting dose and regimen, and adequate safety monitoring based on the patient population and the anticipated toxicities. Proper review and approval of gene therapy clinical studies by numerous committees, and regulatory agencies before and throughout the study allows for ongoing risk assessment of these novel and innovative products. The ethical conduct of clinical trials must be a priority for all clinical investigators and sponsors. As history has shown us, only a few fatal mistakes can dramatically alter the regulation of investigational products for all individuals involved in gene therapy clinical research, and further delay the advancement of gene therapy to licensed medicinal products.
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 , Cardiovascular diseases , Infections , Injuries , and Mental Health . 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).
Weedman, Daniel W.
An astronomer gives teachers tips on learning how to look at the night sky then on passing along personal instruction to students. Presents ideas for finding information through astronomers at colleges, science museums, planetariums, research observatories, and on the World Wide Web. Contains a resource list and foldout poster of galaxies with…
Rico-Villademoros, Fernando; Hernando, Teresa; Sanz, Juan-Luis; López-Alonso, Antonio; Salamanca, Oscar; Camps, Carlos; Rosell, Rafael
Background The purpose of this study was to determine the standard tasks performed by clinical research coordinators (CRCs) in oncology clinical trials. Methods Forty-one CRCs were anonymously surveyed, using a four-page self-administered questionnaire focused on demographics, qualifications, and professional experience. The survey questions on responsibilities consisted of an ad-hoc 32-item questionnaire where respondents had to rate the frequency of involvement in the listed activities using a 3-point scale. We defined as "standard" a task that was rated as "in all or nearly all trials" by at least half of the respondents. Results A response rate of 90% (37 out of 41) was achieved after two mailings. Less than half of the respondents had received additional training in oncology, clinical research or Good Clinical Practices (GCP). Overall, all standard tasks performed by CRCs were in the category of "monitoring activities" (those usually performed by a Clinical Research Associate "CRA") and included patient registration/randomization, recruitment follow-up, case report form completion, collaboration with the CRA, serious adverse events reporting, handling of investigator files, and preparing the site for and/or attending audits. Conclusions CRCs play a key role in the implementation of oncology clinical trials, which goes far beyond mere data collection and/or administrative support, and directly contributes to the gathering of good quality data. PMID:15043760
Kane, Alice E; Hilmer, Sarah N; Mach, John; Mitchell, Sarah J; de Cabo, Rafael; Howlett, Susan E
The ethical, logistical, and biological complications of working with an older population of people inherently limits clinical studies of frailty. The recent development of animal models of frailty, and tools for assessing frailty in animal models provides an invaluable opportunity for frailty research. This review summarizes currently published animal models of frailty including the interleukin-10 knock-out mouse, the mouse frailty phenotype assessment tool, and the mouse clinical frailty index. It discusses both current and potential roles of these models in research into mechanisms of frailty, interventions to prevent/delay frailty, and the effect of frailty on outcomes. Finally, this review discusses some of the challenges and opportunities of translating research findings from animals to humans.
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 IRBs 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. PMID:26374677
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.
Kane, Alice E; Hilmer, Sarah N; Mach, John; Mitchell, Sarah J; de Cabo, Rafael; Howlett, Susan E
The ethical, logistical, and biological complications of working with an older population of people inherently limits clinical studies of frailty. The recent development of animal models of frailty, and tools for assessing frailty in animal models provides an invaluable opportunity for frailty research. This review summarizes currently published animal models of frailty including the interleukin-10 knock-out mouse, the mouse frailty phenotype assessment tool, and the mouse clinical frailty index. It discusses both current and potential roles of these models in research into mechanisms of frailty, interventions to prevent/delay frailty, and the effect of frailty on outcomes. Finally, this review discusses some of the challenges and opportunities of translating research findings from animals to humans. PMID:27822024
Economics and demography are driving drug development to the developing world. India needs this opportunity to build research skills required to combat its enormous disease burden. A variety of global and local contract research organizations (CROs) that specialize in the execution of research to develop health care products operate in India today. CROs assure quality and compliance to regulations while coordinating with tertiary providers such as a site management organization and the central laboratory. Back room operations to manage, analyze, and report data form a bulk of the employment generated by clinical research, absorbing programmers, data managers, biostatisticians,and medical writers. Despite rapid growth and strong potential, India remains a minor contributor to global pharmaceutical research because of policy stagnation, regulatory gaps, and misinformed controversies in the media.
Krishna, Rajeev; Kelleher, Kelly; Stahlberg, Eric
Electronic medical record keeping has led to increased interest in analyzing historical patient data to improve care delivery. Such research use of patient data, however, raises concerns about confidentiality and institutional liability. Institutional review boards must balance patient data security with a researcher’s ability to explore potentially important clinical relationships. We considered the issues involved when patient records from health care institutions are used in medical research. We also explored current regulations on patient confidentiality, the need for identifying information in research, and the effectiveness of deidentification and data security. We will present an algorithm for researchers to use to think about the data security needs of their research, and we will introduce a vocabulary for documenting these techniques in proposals and publications. PMID:17329644
Selva, Marta; Sola, Anna
Examines television news programs as media for discovering diversity. Discusses television as a means of information and communication, its role in the creation of public opinion, its inability to permit understanding, and the need for empirical research to assess its influence on cognitive processes. (AEF)
Scientists have discovered three new active volcanoes in the Newer Volcanics Province (NVP) in southeast Australia. Researchers from Monash University in Melbourne describe in the Australian Journal of Earth Sciences how they used a combination of satellite photographs, detailed topography models from NASA, the distribution of magnetic minerals in the rocks, and site visits to analyze the region.
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.
Malaria still remains one of the main public health problems in the world. In spite of early and numerous clinical trials, the situation seems to have been worsening in the last ten years. Malaria clinical research involves several levels: Several meta-analyses have been performed on this topic (in particular, the Cochrane Database Library has published studies on malaria prevention during pregnancy, management of clinical malaria attacks, vaccine trials or impregnated bed net trials). All these studies show the uneven quality of trials (only 10% to 50% can be kept in the analysis for methodological reasons), which seldom lead to similar conclusions. Besides, as resistances of both parasites and vectors to drugs or insecticides are regularly increasing, trials have to be repeated and new molecules have to be found and evaluated. Finally, practical application of such interventions may be difficult, due to the heterogeneity of epidemiological situations and the poverty of target populations. Various initiatives aiming to develop malaria clinical research have recently been launched. Donators are public or international (Global Fund, Roll Back Malaria Initiative, NIH, EDCTP programme), as well as private (Bill & Melinda Gates Foundation). These substantial funds should enhance the research of new antimalarial drugs and large-scale, adequately designed trials. However, to make sure these trials really benefit to populations exposed to the disease, ethical principles should be co-elaborated with developing countries, within collaborative networks between laboratories from industrialized and developing countries.
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.
Cao, Xinhua; Hoo, Kent S., Jr.; Zhang, Hong; Ching, Wan; Zhang, Ming; Wong, Stephen T. C.
We described a web-based data warehousing method for retrieving and analyzing neurological multimedia information. The web-based method supports convenient access, effective search and retrieval of clinical textual and image data, and on-line analysis. To improve the flexibility and efficiency of multimedia information query and analysis, a three-tier, multimedia data warehouse for epilepsy research has been built. The data warehouse integrates clinical multimedia data related to epilepsy from disparate sources and archives them into a well-defined data model.
Justice, R L
Formal auditing of clinical research data has become a standard contemporary practice within the pharmaceutical industry. Its basic purpose is to provide documentation relevant to an assessment of the quality and integrity of data collected in the course of a clinical trial. This paper outlines the audit procedures developed within one major pharmaceutical firm. These procedures require an intensive investigation of internal and external aspects of study management, records management, data entry, data analysis and statistical report preparation. A qualitative evaluation of the results achieved by this auditing procedure are presented.
Hargens, Alan R.; Akeson, Wayne H.; Mubarak, Scott J.; Owen, Charles A.; Gershuni, David H.
This paper describes clinical applications of two basic research tools developed and refined in the past 20 years: the wick catheter (for measuring tissue fluid pressure) and the colloid osmometer (for measuring osmotic pressure). Applications of the osmometer include estimations of the reduced osmotic pressure of sickle-cell hemoglobin with deoxygenation, and of reduced swelling pressure of human nucleus pulposus with hydration or upon action of certain enzymes. Clinical uses of the wick-catheter technique include an improvement of diagnosis and treatment of acute and chronic compartment syndromes, the elucidation of the tissue pressure thresholds for neuromuscular dysfunction, and the development of a better tourniquet for orthopedics.
Balas, E Andrew; Vernon, Marlo; Magrabi, Farah; Gordon, Lynne Thomas; Sexton, Joanne
Electronic Health Records (EHR) promise improvement for patient care and also offer great value for biomedical research including clinical, public health, and health services research. Unfortunately, the full potential of EHR big data research has remained largely unrealized. The purpose of this study was to identify rate limiting factors, and develop recommendations to better balance unrestricted extramural EHR access with legitimate safeguarding of EHR data in retrospective research. By exploring primary, secondary, and tertiary sources, this review identifies external constraints and provides a comparative analysis of social influencers in retrospective EHR-based research. Results indicate that EHRs have the advantage of reflecting the reality of patient care but also show a frequency of between 4.3-86% of incomplete and inaccurate data in various fields. The rapid spread of alternative analytics for health data challenges traditional interpretations of confidentiality protections. A confusing multiplicity of controls creates barriers to big data EHR research. More research on the use of EHR big data is likely to improve accuracy and validity. Information governance and research approval processes should be simplified. Comprehensive regulatory policies that do not exclusively cover health care entities, are needed. Finally, new computing safeguards are needed to address public concerns, like research access only to aggregate data and not to individually identifiable information.
The mini-review gives special attention to holistic approach and mechanisms of processes. The physical and chemical frames and background for visual perception and signaling are discussed. Perception of photons by retinal rod cells is described in more detail starting from photon absorption and culminating in ion currents. Dark noise and temperature-dependence of photocurrents in photoreceptor cells are analyzed. Perception of polarized light, its effects and informational importance are discussed based on underlying mechanisms and specialized morphological structures of biological organisms. Role of statistics of photons in photoreception is questioned. The review also pinpoints new and developing directions and raises questions for future research. PMID:25328636
Oertel, Bruno Georg; Lötsch, Jörn
The medical impact of pain is such that much effort is being applied to develop novel analgesic drugs directed towards new targets and to investigate the analgesic efficacy of known drugs. Ongoing research requires cost-saving tools to translate basic science knowledge into clinically effective analgesic compounds. In this review we have re-examined the prediction of clinical analgesia by human experimental pain models as a basis for model selection in phase I studies. The overall prediction of analgesic efficacy or failure of a drug correlated well between experimental and clinical settings. However, correct model selection requires more detailed information about which model predicts a particular clinical pain condition. We hypothesized that if an analgesic drug was effective in an experimental pain model and also a specific clinical pain condition, then that model might be predictive for that particular condition and should be selected for development as an analgesic for that condition. The validity of the prediction increases with an increase in the numbers of analgesic drug classes for which this agreement was shown. From available evidence, only five clinical pain conditions were correctly predicted by seven different pain models for at least three different drugs. Most of these models combine a sensitization method. The analysis also identified several models with low impact with respect to their clinical translation. Thus, the presently identified agreements and non-agreements between analgesic effects on experimental and on clinical pain may serve as a solid basis to identify complex sets of human pain models that bridge basic science with clinical pain research. PMID:23082949
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...
Wu, Huikun; Li, Xiaodong; Yang, Fan; Xie, Dan; Li, Hui; Huang, Jingjing; Guo, Mingxing
Hubei Provincial Hospital of Traditional Chinese Medicine established research outpatient clinics to contribute to the major disease-entity research conducted by the National Traditional Chinese Medicine Clinical Research Base and to the construction of the National Traditional Chinese Medicine Treatment and Clinical Research Information Sharing System. With a view of developing a "real-world traditional Chinese medicine clinical research paradigm," these clinics explored the mode of constructing research outpatient clinics from the aspects of clinical research, health management, and characteristics diagnosis and treatment.
de Andrade, Joao; Schwarz, Marvin; Collard, Harold R.; Gentry-Bumpass, Tedryl; Colby, Thomas; Lynch, David; Schwarz, M.; Zisman, D. A.; Hunninghake, G.; Chapman, J.; Olman, M.; Lubell, S.; Morrison, L. D.; Steele, M. P.; Haram, T.; Roman, J.; Perez, R.; Perez, T.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Brown, K. K.; Schwarz, M.; Bair, C.; Kervitsky, D.; Lasky, J. A.; Ditta, S.; deAndrade, J.; Thannickal, V. J.; Stewart, M.; Zisman, D. A.; Lynch, J.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J. A.; Wolters, P. J.; Jeffrey, R.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; White, S. R.; Brown, C.; Garic, I.; Maleckar, S.; Martinez, F. J.; Flaherty, K. R.; Han, M.; Moore, B.; Toews, G. B.; Dahlgren, D.; Raghu, G.; Hayes, J.; Snyder, M.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Mason, W.; Kaner, R. J.; Monroy, V.; Wang, M.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Becker, R. C.; Eisenstein, E. L.; MacIntyre, N. R.; Morrison, L. D; Rochon, J.; Steele, M. P.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Anderson, R.; Beci, R.; Calvert, S.; Cain, K.; Gentry-Bumpass, T.; Hill, D.; Ingham, M.; Kagan, E.; Kaur, J.; Matti, C.; McClelland, J.; Meredith, A.; Nguyen, T.; Pesarchick, J.; Roberts, R. S.; Tate, W.; Thomas, T.; Walker, J.; Whelan, D.; Winsor, J.; Yang, Q.; Yow, E.; Reynolds, H. Y.; Tian, X.; Kiley, J.; Noth, I.; Olman, M.; Schwarz, M.; Toews, G. B.; Hunninghake, G.; Culver, D. A.; Chapman, J.; Olman, M.; Lubell, S.; Wehrmann, R.; Morrison, L. D.; Steele, M. P.; Haram, T.; Kidd, R.; Kallay, M.; Lyda, E.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Sahn, S.; O’Banner, N.; Stokes, F.; Brown, K. K.; Bair, C.; Kervitsky, D.; Ettinger, N. A.; Merli, S.; de Andrade, J.; Thannickal, V. J.; Stewart, M.; Belperio, J.; Lynch, J. P.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J.; Wolters, P.; Eller, A.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; Maleckar, S.; Rahimova, G.; Sardin, L.; Roman, J.; Perez, R.; Perez, T.; Glassberg, M.; Simonet, E.; Martinez, F. J.; Baumann, K.; Chan, K.; Chughtai, A.; Gross, B.; Flaherty, K. R.; Han, M. L.; Hyzy, R.; Kazerooni, E.; Moore, B.; Myers, J.; Toews, G. B.; White, E.; Dahlgren, D.; Rossman, M.; Kreider, M.; Le, K.; Fitzgerald, J.; Glazer, C.; Scholand, M. B.; Brewster, L.; Johnson, A.; Raghu, G.; Berry-Bell, P.; Snydsman, A.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Kinser, K.; Richardson, R.; Mason, W.; Kaner, R. J.; Bandong, K.; Antin-Ozerkis, D.; Holm, C.; Estrom, J.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Eisenstein, E. L.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Beci, R.; Calvert, S.; Gentry-Bumpass, T.; Hill, D.; Hofmann, P. V.; Hwang, K.; Kaur, J.; Matti, C.; Meredith, A.; Pesarchick, J.; Ramey, S.; Roberts, R. S.; Sharlow, A.; Winsor, J.; Yang, Q.; Yow, E.; Weinmann, G. G.; Reynolds, H.; Schmetter, B.; Tian, X.; Kiley, J.; Martinez, F. J.; Raghu, G.; Schwarz, M.; Toews, G. B.; Zibrak, J.; Demersky, A.; Vey, M.; Rosas, I. O.; Debrosse, P.; Culver, D. A.; Chapman, J.; Olman, M.; Lubell, S.; Wehrmann, R.; Morrison, L. D.; Steele, M. P.; Haram, T.; Kidd, R.; Kallay, M.; Lyda, E.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Sahn, S.; O’Banner, N.; Stokes, F.; Padilla, M.; Berhanu, G.; Brown, K. K.; Bair, C.; Kervitsky, D.; Ettinger, N. A.; Merli, S.; Criner, G. J.; Swift, I. Q.; Satti, A.; Cordova, F.; Patel, N.; West, K.; Jones, G.; Lasky, J. A.; Ditta, S.; de Andrade, J.; Thannickal, V. J.; Stewart, M.; Belperio, J.; Lynch, J. P.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J.; Wolters, P.; Eller, A.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; Maleckar, S.; Rahimova, G.; Sardin, L.; Roman, J.; Perez, R.; Perez, T.; Glassberg, M.; Simonet, E.; Martinez, F. J.; Baumann, K.; Chan, K.; Chughtai, A.; Gross, B.; Flaherty, K. R.; Han, M. L.; Hyzy, R.; Kazerooni, E.; Moore, B.; Myers, J.; Toews, G. B.; White, E.; Dahlgren, D.; Rossman, M.; Kreider, M.; Le, K.; Fitzgerald, J.; Glazer, C.; Scholand, M. B.; Brewster, L.; Johnson, A.; Raghu, G.; Berry-Bell, P.; Snydsman, A.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Mason, W.; Kaner, R. J.; Bandong, K.; Antin-Ozerkis, D.; Holm, C.; Estrom, J.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Becker, R. C.; Eisenstein, E. L.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Beci, R.; Calvert, S.; Cain, K.; Gentry-Bumpass, T.; Hill, D.; Huang, K.; Kaur, J.; Matti, C.; Meredith, A.; Pesarchick, J.; Ramey, S.; Roberts, R. S.; Sharlow, A.; Winsor, J.; Yow, E.; Weinmann, G. G.; Reynolds, H.; Schmetter, B.; Tian, X.; Kiley, J.
BACKGROUND: The National Heart, Lung, and Blood Institute-sponsored IPF Clinical Research Network (IPFnet) studies enrolled subjects with idiopathic pulmonary fibrosis (IPF) to evaluate drug therapies in treatment trials. An adjudication committee (AC) provided a structured review of cases in which there was uncertainty or disagreement regarding diagnosis or clinical event classification. This article describes the diagnosis and adjudication processes. METHODS: The diagnostic process was based on review of clinical data and high-resolution CT scans with central review of lung biopsies when available. The AC worked closely with the data coordinating center to obtain clinical, radiologic, and histologic data and to communicate with the clinical centers. The AC used a multidisciplinary discussion model with four clinicians, one radiologist, and one pathologist to adjudicate diagnosis and outcome measures. RESULTS: The IPFnet trials screened 1,015 subjects; of these, 23 cases required review by the AC to establish eligibility. The most common diagnosis for exclusion was suspected chronic hypersensitivity pneumonitis. The AC reviewed 88 suspected acute exacerbations (AExs), 93 nonelective hospitalizations, and 16 cases of bleeding. Determination of AEx presented practical challenges to adjudicators, as necessary clinical data were often not collected, particularly when subjects were evaluated outside of the primary study site. CONCLUSIONS: The IPFnet diagnostic process was generally efficient, but a multidisciplinary adjudication committee was critical to assure correct phenotype for study enrollment. The AC was key in adjudicating all adverse outcomes in two IPFnet studies terminated early because of safety issues. Future clinical trials in IPF should consider logistical and cost issues as they incorporate AExs and hospitalizations as outcome measures. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00517933, NCT00650091, NCT00957242; URL: www.clinicaltrials.gov PMID
Haerian, Krystl; McKeeby, Jon; Dipatrizio, Gary; Cimino, James J
Data errors in electronic health records have been shown to have the potential to adversely impact the conclusions drawn from clinical research. We prospectively studied the efficacy of a new alert to infer errors in previously stored data and to decrease the frequency of data entry errors, in an attempt to improve the quality of data for clinical trials. For the purpose of this study, we monitored data entry errors in height or weight measurements. We predetermined the criteria for probable error as a ten percent variance from a patient's reference value. The care provider entering a value satisfying our error criteria received a disruptive pop-up alert message. The study revealed a significant decrease in the frequency of data errors stored in the EHR, from 2.4% before the alert to 0.9% after the alert. These findings have implications for the development of clinical research trial data collection support tools.
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.
Kondylakis, Haridimos; Tsiknakis, Manolis
Although it is widely accepted that the adoption of computerized clinical guidelines would improve the quality of the provided health care, their influence in the daily practice is limited. In this paper we provide insights on the core topics related to computer interpretable clinical guidelines and we present shortly the main approaches in the area. Then we discuss the current limitations, and we present three simple principles that according to our view should be adopted to enhance the penetration of computerized clinical guidelines in the health care organizations. The overall goal of this paper is not only to give readers a quick overview of the works in the area, but also to provide necessary insights for the practical understanding of the issues involved and draw directions for future research and development activities.
Decker, Summer J; Grajo, Joseph R; Hazelton, Todd R; Hoang, Kimberly N; McDonald, Jennifer S; Otero, Hansel J; Patel, Midhir J; Prober, Allen S; Retrouvey, Michele; Rosenkrantz, Andrew B; Roth, Christopher G; Ward, Robert J
Between 2004 and 2012, US funding for the biomedical sciences decreased to historic lows. Health-related research was crippled by receiving only 1/20th of overall federal scientific funding. Despite the current funding climate, there is increased pressure on academic radiology programs to establish productive research programs. Whereas larger programs have resources that can be utilized at their institutions, small to medium-sized programs often struggle with lack of infrastructure and support. To address these concerns, the Association of University Radiologists' Radiology Research Alliance developed a task force to explore any untapped research productivity potential in these smaller radiology departments. We conducted an online survey of faculty at smaller clinically funded programs and found that while they were interested in doing research and felt it was important to the success of the field, barriers such as lack of resources and time were proving difficult to overcome. One potential solution proposed by this task force is a collaborative structured research model in which multiple participants from multiple institutions come together in well-defined roles that allow for an equitable distribution of research tasks and pooling of resources and expertise. Under this model, smaller programs will have an opportunity to share their unique perspective on how to address research topics and make a measureable impact on the field of radiology as a whole. Through a health services focus, projects are more likely to succeed in the context of limited funding and infrastructure while simultaneously providing value to the field.
Molecular-genetic research in Otolaryngology has seen a rapid advancement during the last ten years, especially in the fields of otology and head and neck tumors. The results of this basic research have now started to be implemented in the clinic. In otology the understanding of auditive function has dramatically improved. The syndromic and non-syndromic forms of hereditary hearing impairment can be subdivided into their underlying genetic defects, as more and more genes are identified. Diagnostic of syndromic hearing loss has been improved and can be done earlier. But the molecular-genetic analysis is still time-consuming and difficult. Currently, in our clinic, only patients with suspected Pendred-syndrome, representing the most frequent syndrome with hearing impairment, undergo a routine search for mutation detection in the corresponding gene SLC26A4. A multitude of genes and mutations are seen in the non-syndromic forms of hereditary hearing impairment. The gene gap-junction-protein beta2, encoding connexin 26, is encountered most frequently. Its prevalence in Switzerland is high with about 20% in the non-syndromic group. A molecular-genetic analysis of connexin 26 is offered in cases of congenital hearing loss. Another analysis, which has been implemented in the clinic, is the sequencing of Wolfram-syndrome gene 1 in familial low-frequency hearing loss. This gene seems to be involved in the majority of families with this type of hearing loss. Gene therapy for hearing loss is currently not an option in the clinical field. The different steps in carcinogenesis of head and neck cancer have further been elucidated by molecular-genetic research. Clinical applications are the establishment of risk-profiles for tumor-development and defining prognostic markers as well as the development of new treatment strategies based on genetic therapy.
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.
Tragus, Robin; Cody, Jannine D
There is a need for metrics that describe the full range of services provided by a clinical research unit; given that services have expanded to include such things as investigator training, regulatory compliance monitoring, and budget negotiations. We developed a tool and methodology that allows tracking of these expanded services. This not only allowed us to more accurately describe the work of the research unit staff, but to monitor the status of a study across the entire study lifespan from the idea to the publication. In addition to measuring work, it allows us to anticipate future needs in clinical staff and expertise because we are involved very early in study planning. We also expect that by analyzing these data from many studies over time, we will identify process barriers that will direct future program improvement.
Henggeler, Scott W; Schaeffer, Cindy M
Multisystemic therapy (MST) is an evidence-based treatment originally developed for youth with serious antisocial behavior who are at high risk for out-of-home placement and their families; and subsequently adapted to address other challenging clinical problems experience by youths and their families. The social-ecological theoretical framework of MST is presented as well as its home-based model of treatment delivery, defining clinical intervention strategies, and ongoing quality assurance/quality improvement system. With more than 100 peer-reviewed outcome and implementation journal articles published as of January 2016, the majority by independent investigators, MST is one of the most extensively evaluated family based treatments. Outcome research has yielded almost uniformly favorable results for youths and families, and implementation research has demonstrated the importance of treatment and program fidelity in achieving such outcomes.
REPORT Final Report for Plant Biofilm Inhibitors to Discover Biofilm Genes 14. ABSTRACT 16. SECURITY CLASSIFICATION OF: To control biofilms , we have...synthesized the natural biofilm inhibitor (5Z)-4-bromo-5-(bromomethylene) -3-butyl-2(5H)-furanone from the red alga Delisea pulchra and determined that...Research Office P.O. Box 12211 Research Triangle Park, NC 27709-2211 15. SUBJECT TERMS biofilms , biofilm inhibitors Thomas K. Wood Texas Engineering
Yu, Yiqin; Zhu, Yu; Sun, Xingzhi; Tao, Ying; Zhang, Shuo; Xu, Linhao; Pan, Yue
This paper presents a clinical informatics toolkit that can assist physicians to conduct cohort studies effectively and efficiently. The toolkit has three key features: 1) support of procedures defined in epidemiology, 2) recommendation of statistical methods in data analysis, and 3) automatic generation of research reports. On one hand, our system can help physicians control research quality by leveraging the integrated knowledge of epidemiology and medical statistics; on the other hand, it can improve productivity by reducing the complexities for physicians during their cohort studies.
Hu, Zhi-De; Zhou, Zhi-Rui; Qian, Shi
Tumor staging serves as an important prognostic factor in cancer patient care. It also plays critical roles in cancer-related clinical research. Aimed to shed lights on how to analyze tumor staging related data and deliver proper interpretation, various statistical methods, from categorical data analysis to modeling techniques, were introduced through the examples. General guidelines were discussed for how to choose proper statistical test with key considerations of research aims, study design, measurement scale of data, proper data summary, type of associations, and underlying assumptions of statistical methods.
Sacristán, José A; Aguarón, Alfonso; Avendaño-Solá, Cristina; Garrido, Pilar; Carrión, Juan; Gutiérrez, Alipio; Kroes, Robert; Flores, Angeles
The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1) setting priorities, 2) study leadership and design, 3) improved access to clinical trials, 4) preparation and oversight of the information provided to participants, 5) post-study evaluation of the patient experience, and 6) the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient. PMID:27175063
The proposal is a key element in the thesis or clinical research project. It identifies what is to be studied, why the topic is relevant, and how the research will be conducted. The proposal is a detailed plan or "blueprint" for the intended study, and once it is completed, the research project should flow smoothly. Writing a proposal may seem like a daunting undertaking, but a little thought and preparation will make it easier. In this article, the author provides a sample research proposal and a set of instructions that the beginning researcher should find helpful.
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
Manna, Claudio; Nardo, Luciano G
The Italian law 40/2004 regulating the use of assisted conception will remain on the statutes after the failure of the referendum in June 2005. Italy is now one of the most restrictive countries in the world in the field of assisted conception. It is thought that the new regulations, which have already increased 'reproductive tourism' in Italian subfertile couples, will also have clinical and research implications.
On Wednesday, November 12, 2014 from 2:00 PM to 3:00 PM EST, Daniel Liebler, PhD (Vanderbilt University) and Karin Rodland, PhD (Pacific Northwestern National Laboratory) and Ruedi Aebersold, PhD (Swiss Federal Institute of Technology) will share their research insight as part of the ASBMB Journal Club. Both Doctors Liebler and Rodland are Principal Investigators in the NCI’s Clinical Proteomic Tumor Analysis Consortium.
Madea, Burkhard; Saukko, Pekka; Musshoff, Frank
In the last years the research output of forensic medicine has sometimes been regarded as insufficient and as of poor quality, especially when parameters as impact factors and external funding were taken into account. However, forensic medicine has different tasks compared to clinical medicine. The main difference between basic subjects, clinical and forensic medicine is not a lack of scientific efficiency in forensic medicine but is a result of the questions asked, the available methods and specific aims. In contrast to natural-scientific research, forensic science has furthermore important intersections with arts and socio-scientific disciplines. Etiologic and pathogenetic research is of only limited relevance in forensic medicine. Thus, forensic medicine is excluded from these research fields, which are mainly supported by external funding. In forensic medicine research mainly means applied research regarding findings, the probative value and reconstruction as well as examination at different points of intersection between medicine and law. Clinical types of research such as controlled randomised, prospective cross-sectional, cohort or case-control studies can only rarely be applied in forensic medicine due to the area specific research fields (e.g. thantatology, violent death, vitality, traffic medicine, analytical toxicology, hemogenetics and stain analysis). The types of studies which are successfully established in forensic medicine are comparison of methods, sensitivity studies, validation of methods, kinetic examinations etc. Tasks of research in forensic medicine and study types, which may be applied will be addressed.
Grimsrud, Kristin N; Sherwin, Catherine M T; Constance, Jonathan E; Tak, Casey; Zuppa, Athena F; Spigarelli, Michael G; Mihalopoulos, Nicole L
Special populations, including women (non-pregnant and pregnant), pediatrics, and the elderly, require additional consideration with regard to clinical research. There are very specific regulatory laws, which protect these special populations, that need to be understood and adhered to in order to perform clinical research. This review provides a broad overview of some of the physiological differences in special populations and discusses how these differences may affect study design and regulatory considerations. These various special populations, with respect to regulatory affairs, are clearly defined within the Code of Federal Regulations. The definition of "special population" exists to provide enhanced awareness of their vulnerabilities, thereby allowing the creation of regulatory guidance aimed to decrease injury or outright harm. Currently, progress is being made to be more inclusive of special populations in clinical trials. This reflects changing attitudes towards drug information, with it being more representative of those patients that will ultimately be prescribed or exposed to the therapy. However, all research undertaken in these populations should be performed in a manner that ensures all protections of each participant are upheld.
Hernandez-Pavon, Julio C.; Sarvas, Jukka; Ilmoniemi, Risto J.
Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a powerful technique for non-invasively studying cortical excitability and connectivity. The combination of TMS and EEG has widely been used to perform basic research and recently has gained importance in different clinical applications. In this paper, we will describe the physical and biological principles of TMS-EEG and different applications in basic research and clinical applications. We will present methods based on independent component analysis (ICA) for studying the TMS-evoked EEG responses. These methods have the capability to remove and suppress large artifacts, making it feasible, for instance, to study language areas with TMS-EEG. We will discuss the different applications and limitations of TMS and TMS-EEG in clinical applications. Potential applications of TMS are presented, for instance in neurosurgical planning, depression and other neurological disorders. Advantages and disadvantages of TMS-EEG and its variants such as repetitive TMS (rTMS) are discussed in comparison to other brain stimulation and neuroimaging techniques. Finally, challenges that researchers face when using this technique will be summarized.
Grimsrud, Kristin N.; Sherwin, Catherine M. T.; Constance, Jonathan E.; Tak, Casey; Zuppa, Athena F.; Spigarelli, Michael G.; Mihalopoulos, Nicole L.
Special populations, including women (non-pregnant and pregnant), pediatrics, and the elderly, require additional consideration with regard to clinical research. There are very specific regulatory laws, which protect these special populations, that need to be understood and adhered to in order to perform clinical research. This review provides a broad overview of some of the physiological differences in special populations and discusses how these differences may affect study design and regulatory considerations. These various special populations, with respect to regulatory affairs, are clearly defined within the Code of Federal Regulations. The definition of “special population” exists to provide enhanced awareness of their vulnerabilities, thereby allowing the creation of regulatory guidance aimed to decrease injury or outright harm. Currently, progress is being made to be more inclusive of special populations in clinical trials. This reflects changing attitudes towards drug information, with it being more representative of those patients that will ultimately be prescribed or exposed to the therapy. However, all research undertaken in these populations should be performed in a manner that ensures all protections of each participant are upheld. PMID:26401094
... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Science Research and Development Service on the relevance and feasibility of proposed projects and...
Higgs, Elizabeth S; Hayden, Frederick G; Chotpitayasunondh, Tawee; Whitworth, Jimmy; Farrar, Jeremy
The Southeast Asia Influenza Clinical Research Network (SEA ICRN) (www.seaclinicalresearch.org) is a recently developed multilateral, collaborative partnership that aims to advance scientific knowledge and management of human influenza through integrated clinical investigation. The partnership of hospitals and institutions in Indonesia, Thailand, United Kingdom, United States, and Viet Nam was established in late 2005 after agreement on the general principles and mission of the initiative and after securing initial financial support. The establishment of the SEA ICRN was both a response to the re-emergence of the highly pathogenic avian influenza A(H5N1) virus in Southeast Asia in late 2003 and an acknowledgment that clinical trials on emerging infectious diseases require prepared and coordinated research capacity. The objectives of the Network also include building sustainable research capacity in the region, compliance with international standards, and prompt dissemination of information and sharing of samples. The scope of research includes diagnosis, pathogenesis, treatment and prevention of human influenza due to seasonal or novel viruses. The Network has overcome numerous logistical and scientific challenges but has now successfully initiated several clinical trials. The establishment of a clinical research network is a vital part of preparedness and an important element during an initial response phase to a pandemic.
Seibyl, J; Jennings, D; Tabamo, R; Marek, K
The increasing availability of PET imaging in nuclear medicine expands the armamentarium of clinical and research tools for improving diagnosis and treatment of neuropsychiatric disorders. Nonetheless, the role of SPECT imaging remains critical to both research and clinical practice. The development of rational strategies for guiding the selection of imaging modalities flows from primarily the nature of the clinical or research question and the availability of appropriate radiopharmaceuticals. There has been extensive SPECT and PET work in Parkinson's disease (PD) which highlights the value of both these scintigraphic modalities. Three main areas of interest in PD include imaging for improving diagnostic accuracy, for monitoring the progression of disease, and for assessing the therapeutic efficacy of drugs with neuroprotective potential. The demands of the clinical or research question posed to imaging dictates the selection of radiotracer and imaging modality. Diagnosis of PD represents the easiest challenge with many imaging biomarkers showing high sensitivity for detecting abnormal reduction of dopaminergic function based on qualitative review of images. On the other hand, using imaging to evaluate treatments which purportedly slow the rate of disease progression, indicated by the reduction in the rate of loss in a quantitative imaging signal in patients studied over time, represents the most rigorous requirement of the imaging measure. In each of these applications presynaptic markers of dopaminergic function using SPECT and PET have been extremely valuable. Review of neuroimaging studies of PD provides a useful example of optimized approaches to clinical and research studies in neuropsychiatric disorders.
Rogers, Eliot; Rodriguez, Tony; Lord, John; Alattar, Adnan
This paper reports on the implementation of the Digimarc® Discover platform on Google Glass, enabling the reading of a watermark embedded in a printed material or audio. The embedded watermark typically contains a unique code that identifies the containing media or object and a synchronization signal that allows the watermark to be read robustly. The Digimarc Discover smartphone application can read the watermark from a small portion of printed image presented at any orientation or reasonable distance. Likewise, Discover can read the recently introduced Digimarc Barcode to identify and manage consumer packaged goods in the retail channel. The Digimarc Barcode has several advantages over the traditional barcode and is expected to save the retail industry millions of dollars when deployed at scale. Discover can also read an audio watermark from ambient audio captured using a microphone. The Digimarc Discover platform has been widely deployed on the iPad, iPhone and many Android-based devices, but it has not yet been implemented on a head-worn wearable device, such as Google Glass. Implementing Discover on Google Glass is a challenging task due to the current hardware and software limitations of the device. This paper identifies the challenges encountered in porting Discover to the Google Glass and reports on the solutions created to deliver a prototype implementation.
Herrett, Emily; Gallagher, Arlene M; Bhaskaran, Krishnan; Forbes, Harriet; Mathur, Rohini; van Staa, Tjeerd; Smeeth, Liam
The Clinical Practice Research Datalink (CPRD) is an ongoing primary care database of anonymised medical records from general practitioners, with coverage of over 11.3 million patients from 674 practices in the UK. With 4.4 million active (alive, currently registered) patients meeting quality criteria, approximately 6.9% of the UK population are included and patients are broadly representative of the UK general population in terms of age, sex and ethnicity. General practitioners are the gatekeepers of primary care and specialist referrals in the UK. The CPRD primary care database is therefore a rich source of health data for research, including data on demographics, symptoms, tests, diagnoses, therapies, health-related behaviours and referrals to secondary care. For over half of patients, linkage with datasets from secondary care, disease-specific cohorts and mortality records enhance the range of data available for research. The CPRD is very widely used internationally for epidemiological research and has been used to produce over 1000 research studies, published in peer-reviewed journals across a broad range of health outcomes. However, researchers must be aware of the complexity of routinely collected electronic health records, including ways to manage variable completeness, misclassification and development of disease definitions for research. PMID:26050254
Breath research is now well established and is solving some of the applications in the area of identifying volatiles for medical diagnosis. This paper looks at how this research has been taken to an end-user market. It is not intended to be an indepth study of the science but simply to draw attention to the role of the commercial link between the researcher and end-user. This market is not only in research but exists in hospitals, clinics, sports medicine and even homecare. The link between research and the end-user market is a vital one to avoid breath analysis being the tool of researchers only. The ubiquitous use of breath analysis depends upon it. This is a review of some of the success stories in commercializing the important breath analysis research that has been conducted over the last few decades. In order to make breath analysis the new blood test, products that have end-user appeal need to be developed and routes to market established.
Boyd, Elizabeth A; Cho, Mildred K; Bero, Lisa A
As industry sponsorship of clinical research grows, investigators' personal financial relationships with those sponsors are under increasing scrutiny. The federal government, some states, and many universities have enacted conflict-of-interest policies to monitor and regulate investigators' financial relationships. Little is known, however, about investigators' awareness of or support for these policies or their attitudes toward regulatory efforts. To explore the possible implications of conflict-of-interest policies for clinical researchers, the authors interviewed active clinical investigators at two institutions where the conflict-of-interest policies differ. The most striking feature of the interviews was the range of perceptions and attitudes expressed by clinical investigators and their implications for administrators, professional societies, and policymakers concerned with conflicts of interest. Fewer than half of the interviewed investigators could accurately describe their campus' conflict-of-interest policy. Many investigators felt that professional societies, the public, and individual investigators were appropriate monitors of conflicts of interest. Many investigators recognized the general risks associated with conflicts of interest, but felt that they personally were not at risk. A fundamental challenge facing administrators and policymakers is to demonstrate to all investigators, both clinical and nonclinical, that the potential for bias, pressure and conflict is relevant to all investigators with industry relationships.
van Eck, Nees Jan; Waltman, Ludo; van Raan, Anthony F. J.; Klautz, Robert J. M.; Peul, Wilco C.
Background 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. Methodology 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. Results 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. Conclusions 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. PMID:23638064
Hatfield, Isabella; Allison, Annabel; Flight, Laura; Julious, Steven A; Dimairo, Munyaradzi
Adaptive designs have the potential to improve efficiency in the evaluation of new medical treatments in comparison to traditional fixed sample size designs. However, they are still not widely used in practice in clinical research. Little research has been conducted to investigate what adaptive designs are being undertaken. This review highlights the current state of registered adaptive designs and their characteristics. The review looked at phase II, II/III and III trials registered on ClinicalTrials.gov from 29 February 2000 to 1 June 2014, supplemented with trials from the National Institute for Health Research register and known adaptive trials. A range of adaptive design search terms were applied to the trials extracted from each database. Characteristics of the adaptive designs were then recorded including funder, therapeutic area and type of adaptation. The results in the paper suggest that the use of adaptive designs has increased. They seem to be most often used in phase II trials and in oncology. In phase III trials, the most popular form of adaptation is the group sequential design. The review failed to capture all trials with adaptive designs, which suggests that the reporting of adaptive designs, such as in clinical trials registers, needs much improving. We recommend that clinical trial registers should contain sections dedicated to the type and scope of the adaptation and that the term 'adaptive design' should be included in the trial title or at least in the brief summary or design sections.
Fisher, Jill A.
Change in the way new drugs are developed, including the privatization of clinical trials, has altered the arrangement and roles of health care professions. In this article I examine one aspect of this change: the role of research coordinators in the conduct of contract research in the United States. My focus on coordinators highlights the ethical conflicts embedded in clinical trials. I describe the ways in which coordinators experience and contend with the conflict between research and care and show how their construction of ethics is distinct from institutional conceptions formally associated with human subjects research. My analysis demonstrates how the coordinators' focus on ethics is a response to their role conflict and an attempt to reinsert individualized care into the context of research. PMID:17184412
Kim, Hyunah; Jeong, Yoo Jin; Kim, Tong Min; Yang, So Jung; Baik, Sun Jung; Lee, Seung-Hwan; Cho, Jae Hyoung
Background The increasing use of electronic medical record (EMR) systems for documenting clinical medical data has led to EMR data being increasingly accessed for clinical trials. In this study, a database of patients who were prescribed statins for the first time was developed using EMR data. A clinical data mart (CDM) was developed for cohort study researchers. Methods Seoul St. Mary's Hospital implemented a clinical data warehouse (CDW) of data for ~2.8 million patients, 47 million prescription events, and laboratory results for 150 million cases. We developed a research database from a subset of the data on the basis of a study protocol. Data for patients who were prescribed a statin for the first time (between the period from January 1, 2009 to December 31, 2015), including personal data, laboratory data, diagnoses, and medications, were extracted. Results We extracted initial clinical data of statin from a CDW that was established to support clinical studies; the data was refined through a data quality management process. Data for 21,368 patients who were prescribed statins for the first time were extracted. We extracted data every 3 months for a period of 1 year. A total of 17 different statins were extracted. It was found that statins were first prescribed by the endocrinology department in most cases (69%, 14,865/21,368). Conclusion Study researchers can use our CDM for statins. Our EMR data for statins is useful for investigating the effectiveness of treatments and exploring new information on statins. Using EMR is advantageous for compiling an adequate study cohort in a short period. PMID:28256114
Coppini, Raffaele; Simons, Sinno H P; Mugelli, Alessandro; Allegaert, Karel
To date, up to 65% of drugs used in neonates and infants are off-label or unlicensed, as they were implemented in clinical care without the usual regulatory phases of pharmacological drug development. Pharmacotherapy in this age group is still mainly based on the individual clinical expertise of specialized pediatricians. Pharmacological trials involving neonates are indeed more difficult to perform: appropriate dosing is hampered by the rapid physiological changes occurring at this stage of development, and the selection of proper end-points and biomarkers is complicated by the limited knowledge of the pathophysiology of the specific diseases of infancy. Moreover, there are many ethical challenges in planning and conducting drug studies in pediatric patients (especially in newborns and infants). In the current review, we address some challenges and discuss possible perspectives to stimulate scientific and clinical pharmacological research in neonates and infants. We hereby aim to illustrate the add on value of the regulatory framework for model-based neonatal medicinal development currently used in Europe and the United States. We provide several examples of successful recent pharmacological trials performed in neonates and infants. In these examples, success was ensured by the implementation of specific pharmacokinetic assessments, thanks to accurate drug dosing achieved with a combination of dose validation, population pharmacokinetics and mathematical models of drug clearance and distribution; moreover, age-specific pharmacodynamics was considered via appropriate evaluations of drug efficacy with end-points adapted to the peculiar pathophysiology of diseases in this age group. These "pharmacological" challenges add to the ethical challenges that are always present in planning and conducting clinical studies in neonates and infants and support the opinion that clinical research in pediatrics should be evaluated by ad hoc ethical committees with specific
Baeyens, A J
With the adoption of the Clinical Trials Directive it was Europe's intention to make the performance of multi-national clinical trials in Europe easier through the harmonization of the regulatory procedures. As the Directive was mainly conceived to facilitate the performance of multi-national clinical trials to develop new drugs, it is to be determined to what extent academic clinical trials will be concerned by the Directive and more importantly what will be its impact on daily academic clinical research. Contrary to several national regulations the scope of the Directive is very large only excluding non-interventional trials. This implies that most of the academic clinical trials will be concerned by the Directive. Besides the handling of the regulatory procedures in the different countries, issues related to insurance, labeling requirements and provision of the investigational medical products will expose the academic sponsor to additional administrative and financial challenges that will have to be handled appropriately, as the academic sponsors will be controlled by Inspectors regarding their compliance with the new regulations to come.
... Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and... Collection Title: The Impact of Clinical Research Training and Medical Education at the Clinical Center on... of the value of the training provided by the Office of Clinical Research Training and...
... for OMB Review; 30-Day Comment Request: Application Process for Clinical Research Training and Medical... contact: Robert M. Lembo, MD, Deputy Director, Office of Clinical Research Training and Medical Education... Process for Clinical Research Training and Medical Education at the Clinical Center and its Impact...
Cohen, Perry D; Herman, Linda; Jedlinski, Sheryl; Willocks, Peggy; Wittekind, Paula
A patient-centered paradigm for clinical research and medical care is presented as a solution to the problem of declining innovation and increasing costs and development time in the pipeline for new therapies. Fundamental differences in values and motivations among scientists, clinicians, industry sponsor, and patients in neurotherapeutics provide a framework for analysis of ethical conflicts and the loss of public confidence in medical research. Parkinson advocates' views on clinical trial participation, perceived risks and benefits, placebo controls, and sham surgery are presented. These views reflect the sense of urgency and the unique perspective that comes from living with this progressive, debilitating condition full time. A patient-centered paradigm that includes authentic voices of patients as collaborators at every stage of development will help to resolve conflicts, build trust, recruit trial participants, and accelerate new therapies. Key elements are adaptive clinical trial methods and the development of information technology for the assessment of outcomes and surveillance of safety over the life cycle of a medical product. Supported by the Parkinson's Disease Foundation, the Parkinson Pipeline Project is a grassroots group of Parkinson's patients whose goal is to represent an authentic voice for patients in the treatment development process. This group promotes education and communication between members of the Parkinson's community and active stakeholders in medical research, industry, and regulatory agencies. Its members are an example of a new breed of knowledgeable consumers, armed with first-hand access to research findings and reinforced by on-line connections to like-minded peers throughout the world.
Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring "additional protections," often referred to as "vulnerable populations." The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential research subjects needing additional protections. In this paper, I assess critically the role of this categorization of pregnant women involved in research as "vulnerable," both as separate entities and in combination with the fetuses they carry. In particular, I do three things: (1) demonstrate that pregnant women qua pregnancy are either not "vulnerable" according to any meaningful definition of that term or that such vulnerability is irrelevant to her status as a research participant; (2) argue that while a fetus may be vulnerable in terms of dependency, this categorization does not equate to the vulnerability of the pregnant woman; and (3) suggest that any vulnerability that appends to women is precisely the result of federal regulations and dubious public perceptions about pregnant women. I conclude by demonstrating how this erroneous characterization of pregnant women as "vulnerable" and its associated protections have not only impeded vital research for pregnant women and their fetuses, but have also negatively affected the inclusion of all women in clinical research.
Tan, Meng H; Bernstein, Steven J; Gendler, Stephen; Hanauer, David; Herman, William H
Background and Aim 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). Method 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. Results After 5 years, the DRR has over 5,000 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. Conclusion 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. PMID:26825022
Siegerink, Bob; Dekkers, Olaf M; Rosendaal, Frits R
Learning to conduct good research demands a considerable investment in terms of time from a young investigator but this is sometimes difficult to achieve alongside studying or training. In 1989, the Dutch Journal of Medicine (NTvG) printed a 'recipe' for conducting a clinical research training project, which made some recommendations for the successful completion of such a project even with limited time and resources. This article reviews these three recommendations and adds another two. The final recommendations are: limit the research question, conduct a pilot study, write the article before you collect the data, streamline the research process and be accountable.
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.
Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S.; Wendler, David
Abstract Objectives: 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. Methods: This study employed a conceptual and normative analysis, and use of an illustrative example. Results: 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. Conclusions: 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
Tabar, A I
Thanks to its excellent safety profile, sublingual immunotherapy has served as a basis for launching two important lines of research in current allergology: sublingual immunotherapy with pharmaceutical registry (oral lyophilizates or tablets), and sublingual immunotherapy with food. At present, clinical trials are being conducted which use rapid dissolution oral lyophilizates. The results of the clinical trials carried out in large patient groups and based on a double-blind methodological design have allowed pharmaceutical registry of this form of treatment, with the therapeutic indications of rhinitis and allergy to grasses. Phleum lyophilizate indicated for the treatment of rhinoconjunctivitis will be marketed in Spain in the coming months. In parallel to development of the sublingual route, advances in our knowledge of pollen allergy and its relationship to plant food allergies have facilitated the conducting of studies involving sublingual immunotherapy for allergy to kiwifruit, hazelnut and peach - thus giving rise to promising future perspectives for affected patients.
Waitman, Lemuel R; Aaronson, Lauren S; Nadkarni, Prakash M; Connolly, Daniel W; Campbell, James R
The Greater Plains Collaborative (GPC) is composed of 10 leading medical centers repurposing the research programs and informatics infrastructures developed through Clinical and Translational Science Award initiatives. Partners are the University of Kansas Medical Center, Children's Mercy Hospital, University of Iowa Healthcare, the University of Wisconsin-Madison, the Medical College of Wisconsin and Marshfield Clinic, the University of Minnesota Academic Health Center, the University of Nebraska Medical Center, the University of Texas Health Sciences Center at San Antonio, and the University of Texas Southwestern Medical Center. The GPC network brings together a diverse population of 10 million people across 1300 miles covering seven states with a combined area of 679 159 square miles. Using input from community members, breast cancer was selected as a focus for cohort building activities. In addition to a high-prevalence disorder, we also selected a rare disease, amyotrophic lateral sclerosis.
Happell, Brenda; Johnston, Linda; Hill, Christine
The lack of research utilization within nursing practice has been extensively discussed in the literature. The Clinical Research Fellowship (CRF) program was developed to assist nurses to change practice on the basis of high-quality research evidence. This paper presents the results of a qualitative study examining the experiences of four CRF participants and three of their unit managers in completing the program and implementing changes within the clinical setting. The major themes to emerge from the data were: experience of the program, outcomes, implementation, assistance from the Centre for Psychiatric Nursing Research and Practice, Victoria, Australia, benefits and drawbacks to the program and whether it would be recommended to others. The findings indicate a positive view of the program itself although problems with the implementation stage were clearly evident. Further support following completion of the program is required to achieve maximum benefit from the program.
... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Research and Development Officer through the Director of the Clinical Science Research and...
... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Chief Research and Development Officer through the Director of the Clinical Science Research...
Tod, Angela M.
The article examines ethical challenges that arise with clinical lung cancer research focusing on design, recruitment, conduct and dissemination. Design: problems related to equipoise can arise in lung cancer studies. Equipoise is an ethics precondition for RCTs and exists where there is insufficient evidence to decide which of two or more treatments is best. Difficulties arise in deciding what level of uncertainty constitutes equipoise and who should be in equipoise, for example, patients might not be even where clinicians are. Patient and public involvement (PPI) can reduce but not remove the problems. Recruitment: (I) lung cancer studies can be complex, making it difficult to obtain good quality consent. Some techniques can help, such as continuous consent. But researchers should not expect consent to be the sole protection for participants’ welfare. This protection is primarily done elsewhere in the research process, for example, in ethics review; (II) the problem of desperate volunteers: some patients only consent to a trial because it gives them a 50/50 option of the treatment they want and can be disappointed or upset if randomised to the other arm. This is not necessarily unfair, given clinical equipoise. However, it should be avoided where possible, for example, by using alternative trial designs; (III) the so-called problem of therapeutic misconception: this is the idea that patients are mistaken if they enter trials believing this to be in their clinical best interest. We argue the problem is misconceived and relates only to certain health systems. Conduct: lung cancer trials face standard ethical challenges with regard to trial conduct. PPI could be used in decisions about criteria for stopping rules. Dissemination: as in other trial areas, it is important that all results, including negative ones, are reported. We argue also that the role of PPI with regard to dissemination is currently under-developed. PMID:27413698
Background Funders of medical research the world over are increasingly seeking, in research assessment, to complement traditional output measures of scientific publications with more outcome-based indicators of societal and economic impact. In the United Kingdom, the Higher Education Funding Council for England (HEFCE) developed proposals for the Research Excellence Framework (REF) to allocate public research funding to higher education institutions, inter alia, on the basis of the social and economic impact of their research. In 2010, it conducted a pilot exercise to test these proposals and refine impact indicators and criteria. Methods The impact indicators proposed in the 2010 REF impact pilot exercise are critically reviewed and appraised using insights from the relevant literature and empirical data collected for the University of Oxford’s REF pilot submission in clinical medicine. The empirical data were gathered from existing administrative sources and an online administrative survey carried out by the university’s Medical Sciences Division among 289 clinical medicine faculty members (48.1% response rate). Results The feasibility and scope of measuring research impact in clinical medicine in a given university are assessed. Twenty impact indicators from seven categories proposed by HEFCE are presented; their strengths and limitations are discussed using insights from the relevant biomedical and research policy literature. Conclusions While the 2010 pilot exercise has confirmed that the majority of the proposed indicators have some validity, there are significant challenges in operationalising and measuring these indicators reliably, as well as in comparing evidence of research impact across different cases in a standardised manner. It is suggested that the public funding agencies, medical research charities, universities, and the wider medical research community work together to develop more robust methodologies for capturing and describing impact
Pullman, Daryl; Etchegary, Holly
ELSI (Ethical, Legal, and Social Issues) is a widely used acronym in the bioethics literature that encompasses a broad range of research areas involved in examining the various impacts of science and technology on society. In Canada, GE3LS (Genetics, Ethical, Economic, Environmental, Legal, Social issues) is the term used to describe ELSI studies. It is intentionally more expansive in that GE3LS explicitly brings economic and environmental issues under its purview. ELSI/GE3LS research has become increasingly important in recent years as there has been a greater emphasis on "translational research" that moves genomics from the bench to the clinic. The purpose of this chapter is to outline a range of ELSI-related work that might be conducted as part of a large scale genetics or genomics research project, and to provide some practical insights on how a scientific research team might incorporate a strong and effective ELSI program within its broader research mandate. We begin by describing the historical context of ELSI research and the development of GE3LS research in the Canadian context. We then illustrate how some ELSI research might unfold by outlining a variety of research questions and the various methodologies that might be employed in addressing them in an area of ELSI research that is encompassed under the term "public engagement." We conclude with some practical pointers about how to build an effective ELSI/GE3LS team and focus within a broader scientific research program.
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. PMID:26952178
Santillan-Doherty, Patricio; Cabral-Castañeda, Antonio; Soto-Ramírez, Luis
The present paper deals with the basic aspects, influences and elements that constitute Informed Consent seeing it as a process and not only as an administrative format. Both the patient-physician relationship, as well as the research subject-investigator relationship, should be seen in the same manner, in spite of recognizing specific objectives for each one. For this reason, Informed Consent should not be different regarding both clinical as well as research activities. The patient-physician relationship presents a disbalance of power within the relationship in favor of the physician; this adds to the moral considerations that take place within both participants. Informed Consent should be defined in a broad sense as all those actions that promote a process of communication and dialogue which facilitates a person in order to make decisions with respect of an action, practice or product that have an impact on his/her body, intimacy or other vital spaces. Informed Consent has influences that originate in basic bioethical principles (autonomy, beneficience, non-maleficence, justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki), as well as legal considerations pertinent to each country. In our country legality emmanates from the General Health Law which, unfortunately, only contemplates Informed Consent as part of the relation established in clinical research. However, the Official Medican Norm on the Clinical Record establishes the conditions where Informed Consent must be obtained during clinical as well as research activities. Primary components of Informed Consent (revelation, capacity to understand and voluntariness), can be better understood when divided into several elements: information, voluntariness, risks and benefits, confidentiality, return of information, utility of the process and management of fragility. Informed Consent should be legally instrumented in an explicit written manner (administrative formats
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.
On behalf of the National Cancer Institute and the Office of Cancer Clinical Proteomics Research, you are invited to the First Annual CPTAC Scientific Symposium on Wednesday, November 13, 2013. The purpose of this symposium, which consists of plenary and poster sessions, is for investigators from CPTAC community and beyond to share and discuss novel biological discoveries, analytical methods, and translational approaches using CPTAC data. All scientists who use, or wish to use CPTAC data are welcome to participate at this free event. The symposium will be held at the Natcher Conference Facility on the main campus of the National Institutes of Health in Bethesda, Maryland.
Heimburger, Douglas C; Carothers, Catherine Lem; Gardner, Pierce; Primack, Aron; Warner, Tokesha L; Vermund, Sten H
The Fogarty International Clinical Research Scholars and Fellows Program's goal is to foster the next generation of clinical investigators and to help build international health research partnerships between American and international investigators and institutions. Through June 2012, 61 sites in 27 countries have hosted 436 Scholars (American students or junior trainees from the host countries) and/or 122 Fellows (American and host country postdoctoral fellows) for year-long experiences in global health research. Initially, the program was oriented toward infectious diseases, but recently emphasis on chronic disease research has increased. At least 521 manuscripts have been published, many in high-impact journals. Projects have included clinical trials, observational studies, translational research, clinical-laboratory interface initiatives, and behavioral research. Strengths of the program include training opportunities for American and developing country scientists in well-established international clinical research settings, and mentorship from experienced global health experts.
Ueda, Yuki; Matsumoto, Hideyuki
The measuring method for glycated albumin (GA) has been developed as a new glycemic control marker since the beginning of the 21st century. Since GA has an advantage in reflecting glycemic status over a shorter period than hemoglobin A1c (HbA1c), much research and many reviews have been reported. However, so far there have been few reports on glycation sites based on the tertiary structure of human serum albumin (HSA) and the comparison of glycation rates between GA and HbA1c in detail. The present review discusses how the glycation sites of lysine residues in HSA are modified with glucose, whereas the glycation sites of lysine residues are located inside of HSA as well as the direct comparison of glycation rates between GA and HbA1c using human blood. Moreover, the most recent clinical researches on GA are described. PMID:25614014
DeFina, Philip A.; Lichtenstein, Jonathan D.; Fellus, Jonathan
Of the approximately 6.8 million Americans who have been diagnosed with dementia, over 5 million have been diagnosed with Alzheimer's Disease (AD). Due to the rise in the aging population, these figures are expected to double by 2050. The following paper provides an up-to-date review of clinical issues and relevant research. Research related to the methods of the earliest possible detection of AD is ongoing. Health care professionals should play a critical role in differentially diagnosing AD patients, as well as supporting their families. Novel interventions, including medications, natural supplements, and behavioral techniques, are constantly appearing in the literature. It is necessary for the health practitioner to remain current, regarding AD, as such information will facilitate better care for patients and their families. PMID:24083026
Zheng, Cheng; Kim, Chanmin; Van Poucke, Sven; Lin, Su; Lan, Peng
Clinical researches usually collected numerous intermediate variables besides treatment and outcome. These variables are often incorrectly treated as confounding factors and are thus controlled using a variety of multivariable regression models depending on the types of outcome variable. However, these methods fail to disentangle underlying mediating processes. Causal mediation analysis (CMA) is a method to dissect total effect of a treatment into direct and indirect effect. The indirect effect is transmitted via mediator to the outcome. The mediation package is designed to perform CMA under the assumption of sequential ignorability. It reports average causal mediation effect (ACME), average direct effect (ADE) and total effect. Also, the package provides visualization tool for these estimated effects. Sensitivity analysis is designed to examine whether the results are robust to the violation of the sequential ignorability assumption since the assumption has been criticized to be too strong to be satisfied in research practice. PMID:27942516
Talavera, Juan O; Rivas-Ruiz, Rodolfo
The second research design with higher quality of information, only after the clinical trial is the cohort, although it does not have the possibility of assigning the maneuver, it has the opportunity to follow subjects over time. Any research that tries to explain the phenomenon of causality runs the risk of bias, however, the characteristics of the cohort studies try to avoid them. Its main features are: 1. Be observational, where the researcher only measures the presence of the maneuver, characteristic that divides subjects into exposed and unexposed. 2. Be longitudinal, which provides the opportunity to track the subject through time documenting the temporal sequence of components ocurrence. 3. The directionality in measurements, generating what we know as prolective, retrolective and retro-prolective cohort studies; the former is the one with the highest quality as a result of the measurement of the variables in real time. 4. Be a comparative study.
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.
van der Kraan, Peter M; Berenbaum, Francis; Blanco, Francisco J; Cosimo, de Bari; Lafeber, Floris; Hauge, Ellen; Higginbottom, Adele; Ioan-Facsinay, Andreea; Loughlin, John; Meulenbelt, Ingrid; Moilanen, Eeva; Pitsillidou, Irene; Tsezou, Aspasia; van Meurs, Joyce; Vincent, Tonia; Wittoek, Ruth; Lories, Rik
Osteoarthritis (OA) accounts for more disability among the elderly than any other disease and is associated with an increased mortality rate. The prevalence in Europe will rise in the future since this continent has a strongly ageing population and an obesity epidemic; obesity and age both being major risk factors for OA. No adequate therapeutic options, besides joint replacement, are available, although they are greatly needed and should be acquired by adequate research investments. However, the perspective on OA from a researcher's point of view is not always aligned with the perspective of a patient with OA. Researchers base their views on OA mainly on abnormalities in structure and function while patients consider OA as a collection of symptoms. In this viewpoint paper, we discuss the possibility of translating the most important clinical problems into pathophysiological research goals to facilitate the translation from bench to bedside and vice versa. This viewpoint is the outcome of a dialogue within the 'European League Against Rheumatism study group on OA' and People with Arthritis/Rheumatism across Europe (PARE) representatives.
Pedersen, Alma B; Mikkelsen, Ellen M; Cronin-Fenton, Deirdre; Kristensen, Nickolaj R; Pham, Tra My; Pedersen, Lars; Petersen, Irene
Missing data are ubiquitous in clinical epidemiological research. Individuals with missing data may differ from those with no missing data in terms of the outcome of interest and prognosis in general. Missing data are often categorized into the following three types: missing completely at random (MCAR), missing at random (MAR), and missing not at random (MNAR). In clinical epidemiological research, missing data are seldom MCAR. Missing data can constitute considerable challenges in the analyses and interpretation of results and can potentially weaken the validity of results and conclusions. A number of methods have been developed for dealing with missing data. These include complete-case analyses, missing indicator method, single value imputation, and sensitivity analyses incorporating worst-case and best-case scenarios. If applied under the MCAR assumption, some of these methods can provide unbiased but often less precise estimates. Multiple imputation is an alternative method to deal with missing data, which accounts for the uncertainty associated with missing data. Multiple imputation is implemented in most statistical software under the MAR assumption and provides unbiased and valid estimates of associations based on information from the available data. The method affects not only the coefficient estimates for variables with missing data but also the estimates for other variables with no missing data.
Pedersen, Alma B; Mikkelsen, Ellen M; Cronin-Fenton, Deirdre; Kristensen, Nickolaj R; Pham, Tra My; Pedersen, Lars; Petersen, Irene
Missing data are ubiquitous in clinical epidemiological research. Individuals with missing data may differ from those with no missing data in terms of the outcome of interest and prognosis in general. Missing data are often categorized into the following three types: missing completely at random (MCAR), missing at random (MAR), and missing not at random (MNAR). In clinical epidemiological research, missing data are seldom MCAR. Missing data can constitute considerable challenges in the analyses and interpretation of results and can potentially weaken the validity of results and conclusions. A number of methods have been developed for dealing with missing data. These include complete-case analyses, missing indicator method, single value imputation, and sensitivity analyses incorporating worst-case and best-case scenarios. If applied under the MCAR assumption, some of these methods can provide unbiased but often less precise estimates. Multiple imputation is an alternative method to deal with missing data, which accounts for the uncertainty associated with missing data. Multiple imputation is implemented in most statistical software under the MAR assumption and provides unbiased and valid estimates of associations based on information from the available data. The method affects not only the coefficient estimates for variables with missing data but also the estimates for other variables with no missing data. PMID:28352203
Monach, Paul A
Researchers often decide whether to average multiple results in order to produce more precise data, and clinicians often decide whether to repeat a laboratory test in order to confirm its validity or to follow a trend. Some of the major sources of variation in laboratory tests (analytical imprecision, within-subject biological variation and between-subject variation) and the effects of averaging multiple results from the same sample or from the same person over time are discussed quantitatively in this article. This analysis leads to the surprising conclusion that the strategy of averaging multiple results is only necessary and effective in a limited range of research studies. In clinical practice, it may be important to repeat a test in order to eliminate the possibility of a rare type of error that has nothing to do analytical imprecision or within-subject variation, and for this reason, paradoxically, it may be most important to repeat tests with the highest sensitivity and/or specificity (i.e., ones that are critical for clinical decision-making).
Ebbels, Susan H
Speech-language pathologists (SLPs) are increasingly required to read, interpret and create evidence regarding the effectiveness of interventions. This requires a good understanding of the strengths and weaknesses of different intervention study designs. This paper aims to take readers through a range of designs commonly used in speech-language pathology, working from those with the least to most experimental control, with a particular focus on how the more robust designs avoid some of the limitations of weaker designs. It then discusses the factors other than research design which need to be considered when deciding whether or not to implement an intervention in clinical practice. The final section offers some tips and advice on carrying out research in clinical practice, with the hope that more SLPs will become actively involved in creating intervention research.
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. PMID:22022152
Müller, Thomas H
Separating patient identification data from clinical data and/or information about biomaterial samples is an effective data protection measure, especially in clinical research employing "on-line", i.e., web-based, data capture. In this paper, we show that this specialised technique can be generalised into a network architecture of interconnected on-line databases potentially serving a variety of purposes. The basic idea of this approach consists of maintaining logical links, i.e., common record keys, between corresponding data structures in pairs of databases while keeping the actual key values hidden from clients. For client systems, simultaneous access to corresponding records is mediated by temporary access tokens. At the relational level, these links are represented by arbitrary unique record keys common to both databases. This architecture allows for integration of related data in different databases without replicating or permanently sharing this data in one place. Each participating on-line database can determine the degree of integration by specifying linkage keys only for those data structures that may be logically connected to other data. Logical links can de designed for specific use cases. In addition, each database controls user access by enforcing its own authorisation scheme. Another advantage is that individual database owners retain considerable leeway in adapting to changing local requirements without compromising the integration into the network. Beyond protecting individual subject identification data, this architecture permits splitting a cooperatively used data pool to achieve many kinds of objectives. Application examples could be clinical registries needing subject contact information for follow-up, biomaterial banks with or without genetic information, and automatic or assisted integration of data from electronic medical records into research data.
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.
Pignatelli, B; Maisonneuve, H; Chapuis, F
Objectives: To assess the knowledge and behaviour of researchers regarding criteria for authorship, and the practices of ghost and gift authorship. Design: Semidirective interviews of senior clinical researchers. Setting: University hospital. Participants: Thirty-nine main investigators of clinical research programmes. Main measurements: Awareness and use of International Committee of Medical Journal Editors (ICMJE) criteria for authorship, and perceptions about ghost and gift authorship. Results: A total of 48 protocols submitted by 42 principal investigators between 1994 and 1996 were identified. Thirty-nine investigators were contacted; 37 (one of whom delegated a co-author) were interviewed between May 2002 and March 2003. Two co-authors of two principal investigators were also interviewed. In all, 42 studies were represented. The interviews lasted for 40–90 minutes and were conducted with openness and respect for confidentiality. The choice of names of co-authors did not follow the ICMJE recommendations. Half of the respondents stated they were aware of criteria for authorship and knew of ICMJE, but most of them did not cite any of the ICMJE criteria among those they applied in deciding authorship. Most of them disagreed with the obligation to meet the three criteria justifying co-authorship because they found these too rigid and inapplicable. Gift authorship was a common practice; 59% of the respondents had been a recipient of gift authorship. Twenty-five (64%) were aware of ghost authorship and the majority considered it questionable and blameworthy. Conclusions: The ICMJE criteria were ignored by clinicians at a university hospital. Ghost and gift authorship were frequent among them. There is a need for French guidelines for authorship to be prepared and implemented. PMID:16199598
Roth, T; Costa e Silva, J A; Chase, M H
The field of memory and sleep is controversial and extremely interesting, and the relationships between thought processes, i.e. cognition and sleep, have recently been examined in a variety of clinical and basic research settings, as well as being the object of intense interest by the general public. For example, there are data which demonstrate that insomnia, as well as specific sleep disorders, can have a negative impact on sleep cognition as well as affect daytime patterns of cognitive functioning. Thus, sleep, disturbed sleep and the lack of sleep appear to affect cognitive and memory functions. An International Workshop dealing with Sleep and Cognitive Function: Research and Clinical Perspectives was convened in Cancún, Mexico, 1-4 March 1999 under the auspices of the World Health Organization Worldwide Project on Sleep and Health and the World Federation of Sleep Research Societies. A great number of areas of intersection between sleep and cognitive function were examined during the course of the Workshop, such as aging, cognition and sleep and the dream process and sleep. The results of these discussions are included in a WHO publication (WHO Doc.: MSD/MBD/00.8). In the present report we concentrate on presenting a summary of a coherent set of data which examine memory consolidation during sleep and the impact of insomnia on cognitive functions. Based upon these data, a review of memory and drug effects that are sleep-related, and an examination of the relationship between hypnotics and cognitive function are included. Finally, a summary of recommendations of the Workshop participants is presented.
... Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact on... project, contact: Robert M. Lembo, MD, Deputy Director, Office of Clinical Research Training and Medical... days of the date of this publication. Proposed Collection: Application Process for Clinical...
for exoplanets More than 100 planets in orbit around stars other than the Sun have been found so far. These "exoplanets" come in many different sizes and they move in a great variety of orbits at different distances from their central star, some nearly round and others quite elongated. Some planets are five to ten times more massive than the largest one in the solar system, Jupiter - the lightest exoplanets known at this moment are about half as massive as Saturn, i.e. about 50 times more massive than the Earth. Astronomers are hunting exoplanets not just to discover more such objects, but also to learn more about the apparent diversity of planetary systems. The current main research goal is to eventually discover an Earth-like exoplanet, but the available telescopes and instrumentation are still not "sensitive" enough for this daunting task. However, also in this context, it is highly desirable to know not only the orbits of the observable exoplanets, but also their true masses . But this is not an easy task. Masses of exoplanets Virtually all exoplanets detected so far have been found by an indirect method - the measurement of stellar velocity variations . It is based on the gravitational pull of the orbiting planet that causes the central star to move a little back and forth; the heavier the planet, the greater is the associated change in the star's velocity. This technique is rapidly improving: the new HARPS spectrograph (High Accuracy Radial Velocity Planet Searcher) , now being tested on the 3.6-m telescope at the ESO La Silla Observatory , can measure such stellar motions with an unrivalled accuracy of about 1 metre per second (m/s), cf. ESO PR 06/03 . It will shortly be able to search for exoplanets only a few times more massive than the Earth. However, velocity measurements alone do not allow to determine the true mass of the orbiting planet. Because of the unknown inclination of the planetary orbit (to the line-of-sight), they only provide a lower limit to
... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...
... AFFAIRS Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... the Director of the Clinical Science Research and Development Service on the relevance and...
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…
Kruegel, Jenny; Rubel, Diana; Gross, Oliver
In 1927, Arthur C. Alport first published his description of a triad of symptoms in a family with hereditary congenital haemorrhagic nephritis, deafness and ocular changes. A few years after his death, this group of symptoms was renamed Alport syndrome. To this day, Alport syndrome still inevitably leads to end-stage renal disease and the need for renal replacement therapy, starting in young adulthood. During the past two decades, research into this rare disease has focused on the effects of mutations in collagen type IV and the role of changes in podocytes and the glomerular basement membrane that lead to early kidney fibrosis. Animal models of Alport syndrome also demonstrate the pathogenetic importance of interactions between podocytes and the extracellular matrix. Such models might also help researchers to answer basic questions about podocyte function and the development of fibrosis, and to develop new therapeutic approaches that might be of use in other kidney diseases. In this Review, we discuss the latest basic and clinical research on Alport syndrome, focusing on the roles of podocyte pathology and the extracellular matrix. We also highlight early diagnosis and treatment options for young patients with this disorder.
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.
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. PMID:24941260
Kuivaniemi, Helena; Ryer, Evan J.; Elmore, James R.; Hinterseher, Irene; Smelser, Diane T.; Tromp, Gerard
An abdominal aortic aneurysm (AAA) is a dilatation of the abdominal aorta with a diameter of at least 3.0 cm. AAAs are often asymptomatic and are discovered as incidental findings in imaging studies or when the AAA ruptures leading to a medical emergency. AAAs are more common in males than females, in individuals of European ancestry, and in those over 65 years of age. Smoking is the most important environmental risk factor. In addition, a positive family history of AAA increases the person's risk for AAA. Interestingly, diabetes has been shown to be a protective factor for AAA in many large studies. Hallmarks of AAA pathogenesis include inflammation, vascular smooth muscle cell apoptosis, extracellular matrix degradation, and oxidative stress. Autoimmunity may also play a role in AAA development and progression. In this Outlook paper, we summarize our recent studies on AAA including clinical studies related to surgical repair of AAA and genetic risk factor and large-scale gene expression studies. We conclude with a discussion on our research projects using large data sets available through electronic medical records and biobanks. PMID:24834361
Klahn, Philipp; Brönstrup, Mark
The development of bacterial resistance against current antibiotic drugs necessitates a continuous renewal of the arsenal of efficacious drugs. This imperative has not been met by the output of antibiotic research and development of the past decades for various reasons, including the declining efforts of large pharma companies in this area. Moreover, the majority of novel antibiotics are chemical derivatives of existing structures that represent mostly step innovations, implying that the available chemical space may be exhausted. This review negates this impression by showcasing recent achievements in lead finding and optimization of antibiotics that have novel or unexplored chemical structures. Not surprisingly, many of the novel structural templates like teixobactins, lysocin, griselimycin, or the albicidin/cystobactamid pair were discovered from natural sources. Additional compounds were obtained from the screening of synthetic libraries and chemical synthesis, including the gyrase-inhibiting NTBI's and spiropyrimidinetrione, the tarocin and targocil inhibitors of wall teichoic acid synthesis, or the boronates and diazabicyclo[3.2.1]octane as novel β-lactamase inhibitors. A motif that is common to most clinically validated antibiotics is that they address hotspots in complex biosynthetic machineries, whose functioning is essential for the bacterial cell. Therefore, an introduction to the biological targets-cell wall synthesis, topoisomerases, the DNA sliding clamp, and membrane-bound electron transport-is given for each of the leads presented here.
... Not Your Average Video Traffic Report : Earth Matters Blogs - DISCOVER-AQ planes have been flying over roadways, ... News Roundup: Arctic Ice, Spacesuit Satellites and More : Earth Matters Blogs - The July 5 flight was part of a summer-long air ...
A newly discovered planetoid, currently dubbed 2004 UN, could be confirmed as the largest such known body in the Kuiper Belt, scientists announced on 19 February.The planetoid, located about 4.4 billion miles from Earth, is estimated at about 1,400 kilometers in diameter, according to Michael Brown, associate professor of planetary astronomy at the California Institute of Technology.
An idea for hands-on activities for families to use in discovering the outdoors together when visiting parks is described. Family packs contain discovery and natural history cards, thermometers, magnifiers, insect boxes, photographs of animals and plants, a pencil, and a feedback form. (SA)
Loveday, Sarah; Mitchell, Ed
Regulations and the number of forms that require completion remain a major frustration for researchers attempting to establish a clinical research project. It is essential that clinical research is of the highest standard and abides by ethical principles. However, the duplication of information required and lack of co-ordination between national and local ethics and research committees is a hindrance to conducting clinical research. This publication highlights the pitfalls in our current system with a case study, and suggests changes to the ethical review process that may aid researchers in establishing clinical research.
Piperno, Alberto; Mariani, Raffaella; Trombini, Paola; Girelli, Domenico
By modulating hepcidin production, an organism controls intestinal iron absorption, iron uptake and mobilization from stores to meet body iron need. In recent years there has been important advancement in our knowledge of hepcidin regulation that also has implications for understanding the physiopathology of some human disorders. Since the discovery of hepcidin and the demonstration of its pivotal role in iron homeostasis, there has been a substantial interest in developing a reliable assay of the hormone in biological fluids. Measurement of hepcidin in biological fluids can improve our understanding of iron diseases and be a useful tool for diagnosis and clinical management of these disorders. We reviewed the literature and our own research on hepcidin to give an updated status of the situation in this rapidly evolving field. PMID:19195055
Nahm, Meredith; Nguyen, Vickie D; Razzouk, Elie; Zhu, Min; Zhang, Jiajie
Medical record abstraction, a primary mode of data collection in secondary data use, is associated with high error rates. Cognitive factors have not been studied as a possible explanation for medical record abstraction errors. We employed the theory of distributed representation and representational analysis to systematically evaluate cognitive demands in medical record abstraction and the extent of external cognitive support employed in a sample of clinical research data collection forms.We show that the cognitive load required for abstraction in 61% of the sampled data elements was high, exceedingly so in 9%. Further, the data collection forms did not support external cognition for the most complex data elements. High working memory demands are a possible explanation for the association of data errors with data elements requiring abstractor interpretation, comparison, mapping or calculation. The representational analysis used here can be used to identify data elements with high cognitive demands.
Müller, Thomas; Foley, Paul
Several compounds developed the treatment of Alzheimer's disease and Parkinson's disease have been clinically unsuccessful. Suggested reasons for these failures have included heterogeneous symptom expression, inappropriate assessment of effects, safety and tolerability hurdles, short duration of disease-modifying trials, recruiting pressure on study centers, administrative and bureaucratic overload, and pooling results from trial centers in different health care systems with differing quality and therapeutic concepts. The solution to these problems will include reducing the costs of drug development, with a concomitant reduction of approval hurdles. Trial designs are influenced by ethics committees, health care officials, political administrations, and research scientists. None have direct contact with the treated patients. Approval of novel therapeutic agents lies in the remit of health care officials, whereby price plays a more dominant role than therapeutic efficacy. Patients and prescribing physicians, however, are better placed to act as arbiters of the efficacy, risks, and overall value of a new drug in practice.
Einhorn, T A
The development of new strategies for the engineering of bone regeneration requires appropriate model systems. Selection of the best model for testing a new technology depends on a host of factors. In general, the best model system is the one which most closely mimics the clinical situation for which this technology is being developed, will not heal spontaneously unless the technology is used, and will not heal when another technology is used if that technology is less advanced than the one being tested. For the purposes of developing new strategies for bone regeneration, systems which can be considered include those which model normal fracture healing, the segmental loss of bone or critical size defects, and various forms of nonunions in which fracture healing is perturbed either by mechanical, metabolic, or neurologic means. Careful experimental design and selection of the appropriate model system will enhance scientific efforts in bone regeneration research.
Ali, Raghib; Finlayson, Alexander; Indox Cancer Research Network
Transnational Organisations increasingly prioritise the need to support local research capacity in low and middle income countries in order that local priorities are addressed with due consideration of contextual issues. There remains limited evidence on the best way in which this should be done or the ways in which external agencies can support this process.We present an analysis of the learning from the INDOX Research Network, established in 2005 as a partnership between the Institute of Cancer Medicine at the University of Oxford and India's top nine comprehensive cancer centres. INDOX aims to enable Indian centres to conduct clinical research to the highest international standards; to ensure that trials are developed to address the specific needs of Indian patients by involving Indian investigators from the outset; and to provide the training to enable them to design and conduct their own studies. We report on the implementation, outputs and challenges of simultaneously trying to build capacity and deliver meaningful research output.
Galante, Emanuela; Gazzi, Lidia; Caffarra, Sendy
The goal of the present review was to present a critical description of psychological research and practice in neurorehabilitation with regard to the efficacy of treatments proposed in the clinical and neuropsychological field. PubMed, Web of Science and Cochrane databases were searched by using the keywords "psychological intervention" and one of the following neurological diseases: "stroke", "TBI", "Parkinson", "ALS", "multiple sclerosis", "dementia". Randomized and pseudo-randomized trials, reviews and single case studies were included. We identified 134 papers: 54 concerning dementia, 24 stroke, 20 multiple sclerosis, 16 Parkinson, 13 TBI and 7 ALS. Most of these papers concern the evaluation of the effectiveness of psychological treatments in chronic or progressive neurological diseases. However, they are often characterized by methodological limitations, such as a small sample size, absence of a follow-up study or a control group. Further, high quality studies could help better understand treatment effects. There was some evidence for effectiveness of cognitive-behavioural and cognitive therapies, often applied both in clinical and neuropsychological interventions. Evidence coming from individualized treatment and single case studies are also described. In line with the data collected, we summarize some evidence available for psychological testing and treatment and argue that a multidisciplinary approach and a multidimensional evaluation should be adopted. According to this position, both randomized trials and single-case studies could be taken into account. Finally, it is proposed that in order to establish the efficacy of a given treatment, both standardized and individualized measures are to be used.
Tarquini, Daniela; Pucci, Eugenio; Gasparini, Maddalena; Zullo, Silvia; Tiraboschi, Pietro; Bonito, Virginio; Defanti, Carlo Alberto
In 2011, the so-called Dubois criteria introduced the use of biomarkers in research (in particular, brain amyloid positron emission tomography imaging and the cerebrospinal fluid levels of tau/fosfo-tau and beta-amyloid 1-42) for the early or preclinical diagnosis of Alzheimer's disease. Even so, we are looking at an increased use of these markers in clinical practice. In the 1960s, Alzheimer's disease was considered a rare form of presenile dementia, but gradually it has been recognized as the prevalent form of old-age dementia. As a consequence, what was once regarded as an inevitable outcome of old age is now recognized as a true disease. Several factors contributed to this paradigm shift, in particular a longer lifespan, new techniques of in vivo study of the central nervous system, and the pressure exerted by the pharmaceutical industry and patient groups. The current lack of disease-modifying therapies and the high incidence of mild cognitive impairment, which is a risk factor for dementia, raise a series of clinical ethical problems ranging from how diagnosis is communicated to how resources are used. This article offers a conceptual scheme through which these issues can be addressed.
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.
Talavera, Juan O; Rivas-Ruiz, Rodolfo
There has been proposed several strategies to select an article under the assumption of quality and relevance. Mostly depend on the presence or absence of a number of features and others, depends of the judgment of other people. However, these strategies do not allow us to know the magnitude of the error contained within each article. And considering that there is not a perfect one, it is important to identify the magnitude of the error and the impact of this in the final result; consequently, it is necessary to develop skills that allow us to review a paper, identify potential errors, and generate a sense of the impact of it over the result. Using the information contained in Clinical Research Series I-VII, we have tried to show its application in a structured review of an article of causality beginning with the revision of the baseline, the maneuver and the outcome, with systematic errors (bias) generated in each section, followed by the appropriate of the statistical test and the sample size used, and finally, the clinical relevance.
Suh, Dong Hoon; Lee, Kyung Hun; Kim, Kidong; Kang, Sokbom; Kim, Jae Weon
In 2014, 9 topics were selected as major advances in clinical research for gynecologic oncology: 2 each in cervical and corpus cancer, 4 in ovarian cancer, and 1 in breast cancer. For cervical cancer, several therapeutic agents showed viable antitumor clinical response in recurrent and metastatic disease: bevacizumab, cediranib, and immunotherapies including human papillomavirus (HPV)-tumor infiltrating lymphocytes and Z-100. The HPV test received FDA approval as the primary screening tool of cervical cancer in women aged 25 and older, based on the results of the ATHENA trial, which suggested that the HPV test was a more sensitive and efficient strategy for cervical cancer screening than methods based solely on cytology. For corpus cancers, results of a phase III Gynecologic Oncology Group (GOG) 249 study of early-stage endometrial cancer with high-intermediate risk factors are followed by the controversial topic of uterine power morcellation in minimally invasive gynecologic surgery. Promising results of phase II studies regarding the effectiveness of olaparib in various ovarian cancer settings are summarized. After a brief review of results from a phase III study on pazopanib maintenance therapy in advanced ovarian cancer, 2 outstanding 2014 ASCO presentations cover the topic of using molecular subtypes in predicting response to bevacizumab. A review of the use of opportunistic bilateral salpingectomy as an ovarian cancer preventive strategy in the general population is presented. Two remarkable studies that discussed the effectiveness of adjuvant ovarian suppression in premenopausal early breast cancer have been selected as the last topics covered in this review.
Suh, Dong Hoon; Kim, Jae-Weon; Kim, Kidong; Kim, Hak Jae; Lee, Kyung-Hun
Ten topics were chosen among major clinical research achievements in gynecologic oncology in 2012. For ovarian cancer, comprehensive review of the history of bevacizumab studies was followed by poly adenosine diphosphate [ADP]-ribose polymerase (PARP) inhibitors and other molecular targeted agents such as epidermal growth factor receptor tyrosine kinase inhibitor and AMG 386. For the development of genomic study in gynecologic cancers, BRCA and DICER1 mutations were covered in epithelial and nonepithelial ovarian cancer, respectively. For endometrial cancer, targeted agents including mammalian target of rapamycin (mTOR) inhibitors and bevacizumab were discussed. Radiation therapy "sandwiched" between combination chemotherapy schedules for the treatment of uterine papillary serous carcinoma was also reviewed. Preoperative prediction of lymph node metastasis, definition of low-risk group, and recurrence and survival outcomes of laparoscopic approaches were addressed. For cervical cancer, we reviewed long-term benefit of human papillomavirus test and efficacy of paclitaxel/carboplatin versus paclitaxel/cisplatin in stage IVB, persistent or recurrent disease. In addition, the effect of three dimensional image-based high-dose rate brachytherapy was also reviewed. For vulvar cancer, the diagnostic value of sentinel lymph node biopsy was discussed. For breast cancer, positive results of three outstanding phase III randomized clinical trials, CLEOPATRA, EMILIA, and BOLERO-2 were introduced. Lastly, updates of major practice guidelines were summarized.
Suh, Dong Hoon; Kim, Kidong; Kim, Hak Jae; Lee, Kyung-Hun
Ten topics were chosen among major clinical research achievements in gynecologic oncology in 2012. For ovarian cancer, comprehensive review of the history of bevacizumab studies was followed by poly adenosine diphosphate [ADP]-ribose polymerase (PARP) inhibitors and other molecular targeted agents such as epidermal growth factor receptor tyrosine kinase inhibitor and AMG 386. For the development of genomic study in gynecologic cancers, BRCA and DICER1 mutations were covered in epithelial and nonepithelial ovarian cancer, respectively. For endometrial cancer, targeted agents including mammalian target of rapamycin (mTOR) inhibitors and bevacizumab were discussed. Radiation therapy "sandwiched" between combination chemotherapy schedules for the treatment of uterine papillary serous carcinoma was also reviewed. Preoperative prediction of lymph node metastasis, definition of low-risk group, and recurrence and survival outcomes of laparoscopic approaches were addressed. For cervical cancer, we reviewed long-term benefit of human papillomavirus test and efficacy of paclitaxel/carboplatin versus paclitaxel/cisplatin in stage IVB, persistent or recurrent disease. In addition, the effect of three dimensional image-based high-dose rate brachytherapy was also reviewed. For vulvar cancer, the diagnostic value of sentinel lymph node biopsy was discussed. For breast cancer, positive results of three outstanding phase III randomized clinical trials, CLEOPATRA, EMILIA, and BOLERO-2 were introduced. Lastly, updates of major practice guidelines were summarized. PMID:23346316
Matzuk, Martin M; Lamb, Dolores J
Reproduction is required for the survival of all mammalian species, and thousands of essential ‘sex’ genes are conserved through evolution. Basic research helps to define these genes and the mechanisms responsible for the development, function and regulation of the male and female reproductive systems. However, many infertile couples continue to be labeled with the diagnosis of idiopathic infertility or given descriptive diagnoses that do not provide a cause for their defect. For other individuals with a known etiology, effective cures are lacking, although their infertility is often bypassed with assisted reproductive technologies (ART), some accompanied by safety or ethical concerns. Certainly, progress in the field of reproduction has been realized in the twenty-first century with advances in the understanding of the regulation of fertility, with the production of over 400 mutant mouse models with a reproductive phenotype and with the promise of regenerative gonadal stem cells. Indeed, the past six years have witnessed a virtual explosion in the identification of gene mutations or polymorphisms that cause or are linked to human infertility. Translation of these findings to the clinic remains slow, however, as do new methods to diagnose and treat infertile couples. Additionally, new approaches to contraception remain elusive. Nevertheless, the basic and clinical advances in the understanding of the molecular controls of reproduction are impressive and will ultimately improve patient care. PMID:18989307
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
Berea-Baltierra, Ricardo; Rivas-Ruiz, Rodolfo; Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Moreno, Jorge; Talavera, Juan O
The complexity of the causality phenomenon in clinical practice implies that the result of a maneuver is not solely caused by the maneuver, but by the interaction among the maneuver and other baseline factors or variables occurring during the maneuver. This requires methodological designs that allow the evaluation of these variables. When the outcome is a binary variable, we use the multiple logistic regression model (MLRM). This multivariate model is useful when we want to predict or explain, adjusting due to the effect of several risk factors, the effect of a maneuver or exposition over the outcome. In order to perform an MLRM, the outcome or dependent variable must be a binary variable and both categories must mutually exclude each other (i.e. live/death, healthy/ill); on the other hand, independent variables or risk factors may be either qualitative or quantitative. The effect measure obtained from this model is the odds ratio (OR) with 95 % confidence intervals (CI), from which we can estimate the proportion of the outcome's variability explained through the risk factors. For these reasons, the MLRM is used in clinical research, since one of the main objectives in clinical practice comprises the ability to predict or explain an event where different risk or prognostic factors are taken into account.
Talavera, Juan O; Rivas-Ruiz, Rodolfo
A statistical test is incomprehensible when it is out of context, so it is necessary to identify the details of the phenomenon of causality in the clinical course of the disease and to integrate the statistical model. Thus, the statistical tests used will try to characterize baseline, maneuver and the outcome, and will show the relationship between them. When we read the results in clinical research, the first thing that the author describes are general characteristics of the population, starting with number of patients evaluated and selected, average age, gender, and number of subjects meeting the outcome. This is extremely important because with the same criteria two studies may contain populations completely opposite. Posterior description usually continues through tables that follow a logical sequence, which allow us to integrate the statistical model to clinical judgment: baseline characteristics of the population and its distribution in each of the maneuvers, characteristics of the main and peripheral maneuvers, main effect of the maneuver on the outcome, and the impact of principal maneuver in the outcome, but adjusted for any variable that can alter this impact.
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
Forte, Amalia; Rinaldi, Barbara; Berrino, Liberato; Rossi, Francesco; Galderisi, Umberto; Cipollaro, Marilena
Restenosis is the pathophysiological process occurring in 10-15% of patients submitted to revascularization procedures of coronary, carotid and peripheral arteries. It can be considered as an excessive healing reaction of the vascular wall subjected to arterial/venous bypass graft interposition, endarterectomy or angioplasty. The advent of bare metal stents, drug-eluting stents and of the more recent drug-eluting balloons, have significantly reduced, but not eliminated, the incidence of restenosis, which remains a clinically relevant problem. Biomedical research in pre-clinical animal models of (re)stenosis, despite its limitations, has contributed enormously to the identification of processes involved in restenosis progression, going well beyond the initial dogma of a primarily proliferative disease. Although the main molecular and cellular mechanisms underlying restenosis have been well described, new signalling molecules and cell types controlling the progress of restenosis are continuously being discovered. In particular, microRNAs and vascular progenitor cells have recently been shown to play a key role in this pathophysiological process. In addition, the advanced highly sensitive high-throughput analyses of molecular alterations at the transcriptome, proteome and metabolome levels occurring in injured vessels in animal models of disease and in human specimens serve as a basis to identify novel potential therapeutic targets for restenosis. Molecular analyses are also contributing to the identification of reliable circulating biomarkers predictive of post-interventional restenosis in patients, which could be potentially helpful in the establishment of an early diagnosis and therapy. The present review summarizes the most recent and promising therapeutic strategies identified in experimental models of (re)stenosis and potentially translatable to patients subjected to revascularization procedures.
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.
Havermahl, Tamara; LaPensee, Elizabeth; Williams, David; Clauw, Daniel; Parker, Robert A.; Downey, Brad; Liu, Jing; Myles, James
The Research Development Core (RDC) is housed within the Michigan Institute for Clinical & Health Research (MICHR) at the University of Michigan (U-M). Established in 2006, RDC provides no-cost, in-person consultations to help U-M investigators strengthen their grant proposals. RDC offers investigators feedback and critique on all aspects of their study design, plus partnerships, funding mechanisms and future directions. This article describes RDC’s model and provides data describing the success of its services. The RDC is composed of a multidisciplinary team of professionals in grant development. It is comprised of two senior faculty co-directors from the U-M Medical School, two senior biostatisticians, outside faculty content experts, and RDC administrative staff. Investigators contact RDC to request a consultation and submit advance grant materials for review by the RDC team. During the consultation, investigators explain their project and identify challenges. The RDC team and additional experts offer feedback that is captured in meeting notes and provided to investigators. RDC commitments beyond the meetings are implemented and carefully tracked. Investigators may also request grant editing, budgeting, or proposal submission assistance. Investigators utilizing RDC have been awarded $44.5 million since 2011. The demand for RDC consultations doubled from 2010 to 2011, and reached a high of 131 consultations in 2012. Investigator feedback has been positive: 80% reported RDC had a strong impact on their proposal, and over 90% indicated they would recommend RDC to colleagues. MICHR is committed to providing investigators with RDC services to better ensure strong grant applications and successful research careers. PMID:25340362
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.
Sargin, Derya; Friedrichs, Heidi; El-Kordi, Ahmed; Ehrenreich, Hannelore
Erythropoietin (EPO), originally discovered as hematopoietic growth factor, has direct effects on cells of the nervous system that make it a highly attractive candidate drug for neuroprotection/neuroregeneration. Hardly any other compound has led to so much preclinical work in the field of translational neuroscience than EPO. Almost all of the >180 preclinical studies performed by many independent research groups from all over the world in the last 12 years have yielded positive results on EPO as a neuroprotective drug. The fact that EPO was approved for the treatment of anemia >20 years ago and found to be well tolerated and safe, facilitated the first steps of translation from preclinical findings to the clinic. On the other hand, the same fact, naturally associated with loss of patent protection, hindered to develop EPO as a highly promising therapeutic strategy for application in human brain disease. Therefore, only few clinical neuroprotection studies have been concluded, all with essentially positive and stimulating results, but no further development towards the clinic has occurred thus far. This article reviews the preclinical and clinical work on EPO for the indications neuroprotection/neuroregeneration and cognition, and hopefully will stimulate new endeavours promoting development of EPO for the treatment of human brain diseases.
McCammon, Margaret G.; Fogg, Thomas T.; Jacobsen, Lynda; Roache, John; Sampson, Royce; Bower, Cynthia L.
In a climate of increased expectation for the translation of research, academic clinical research units are looking at new ways to streamline their operation and maintain effective translational support services. Clinical research, although undeniably expensive, is an essential step in the translation of any medical breakthrough, and as a result, many academic clinical research units are actively looking to expand their clinical services despite financial pressures. We examine some of the hybrid academic-business models in 19 clinical research centers within the Clinical and Translational Science Award consortium that are emerging to address the issue of cost recovery of clinical research that is supported by the United States federal government. We identify initiatives that have succeeded or failed, essential supporting and regulatory components, and lessons learned from experience to design an optimal cost recovery model and a timeline for its implementation. PMID:22764204
Mueller, Eric W; Bishop, Jeffrey R; Kanaan, Abir O; Kiser, Tyree H; Phan, Hanna; Yang, Katherine Y
The American College of Clinical Pharmacy (ACCP) Research Affairs Committee published a commentary in 2013 on training clinical pharmacy scientists in the context of changes in economic, professional, political, and research environments. The commentary centered on the opportunities for pharmacists in clinical/translational research including strategies for ACCP, colleges of pharmacy, and the profession to increase the number and impact of clinical pharmacy scientists. A postdoctoral fellowship is cited as a current training pathway, capable of producing independent and productive pharmacy researchers. However, a decline in the number of programs, decreased funding availability, and variability in fellowship program activities and research focus have brought into question the relevance of this research training pathway to meet demand and opportunities. In response to these points, this commentary examines the state of research fellowship training including the current ACCP research fellowship review process, the need for standardization of research fellowship programs, and strategies to strengthen and promote research fellowships as relevant researcher training pathways.
Background Cellular changes associated with diabetic (DG) and idiopathic gastroparesis (IG) have recently been described from patients enrolled in the Gastroparesis Clinical Research Consortium. The association of these cellular changes with gastroparesis symptoms and gastric emptying is unknown. Aim Relate cellular changes to symptoms and gastric emptying in patients with gastroparesis. Methods Earlier, using full thickness gastric body biopsies from 20 DG, 20 IG and 20 matched controls, we found decreased interstitial cells of Cajal (ICC) and enteric nerves and an increase in immune cells in both DG and IG. Here, demographic, symptoms (gastroparesis cardinal symptom index score), and gastric emptying were related to cellular alterations using Pearson’s correlation coefficients. Results ICC counts inversely correlated with 4 hours gastric retention in DG but not in IG (r=−0.6, p=0.008, DG, r=0.2, p=0.4, IG). There was also a significant correlation between loss of ICC and enteric nerves in DG but not in IG (r=0.5, p=0.03 for DG, r=0.3, p=0.16, IG). IG with a myenteric immune infiltrate scored higher on the average GCSI (3.6±0.7 vs 2.7±0.9, p=0.05) and nausea score (3.8±0.9 vs 2.6±1.0, p=0.02) as compared to those without an infiltrate. Conclusions In DG, loss of ICC is associated with delayed gastric emptying. ICC or enteric nerve loss did not correlate with symptom severity. Overall clinical severity and nausea in IG is associated with a myenteric immune infiltrate. Thus, full thickness gastric biopsies can help define specific cellular abnormalities in gastroparesis, some of which are associated with physiological and clinical characteristics of gastroparesis. PMID:22339929
Michiels, S.; Ternès, N.; Rotolo, F.
With the genomic revolution and the era of targeted therapy, prognostic and predictive gene signatures are becoming increasingly important in clinical research. They are expected to assist prognosis assessment and therapeutic decision making. Notwithstanding, an evidence-based approach is needed to bring gene signatures from the laboratory to clinical practice. In early breast cancer, multiple prognostic gene signatures are commercially available without having formally reached the highest levels of evidence-based criteria. We discuss specific concepts for developing and validating a prognostic signature and illustrate them with contemporary examples in breast cancer. When a prognostic signature has not been developed for predicting the magnitude of relative treatment benefit through an interaction effect, it may be wishful thinking to test its predictive value. We propose that new gene signatures be built specifically for predicting treatment effects for future patients and outline an approach for this using a cross-validation scheme in a standard phase III trial. Replication in an independent trial remains essential. PMID:27634691
Cohen, A F
The relation between a pharmaceutical company and a clinical investigator combines a certain form of entrepreneurship with scientific endeavour. Both parties are concerned with the content of the clinical study as well as with its business aspects. A good contract is essential for the project to succeed. In three cases based on actual experience the contract failed. In the first case, dosage miscalculation in the hospital pharmacy led to side effects in patients as a consequence of which the study was stopped. The pharmaceutical company sued the investigator. In the second case the investigator published data in a congress abstract, which prevented a patent by the company. In the third case scientific information was published by the company with the principal investigator featuring in the acknowledgement section of the article only. Investigators should have their own standard contract ready, and they should invest time and energy in understanding the contracts of the research they are carrying out.
Roy, Kimberlee M; Roberts, Michael C; Stewart, Peter K
This study examined the research productivity of graduates of American Psychological Association accredited, clinical psychology doctoral programs who currently hold faculty positions. Normative averages of aggregated publications over the 2000-2004 five-year period were computed. Rankings based on the mean number of publications produced by graduates of each training program and the number of graduates were significantly correlated with U.S. News and World Report rankings, although some important differences were noted. Programs that have produced a larger number of faculty members were also more highly ranked but there was increased variability for the number of publications produced by the larger numbers of graduates. Objective outcome analyses such as graduates' publications may be preferable to more subjective reputation rankings of programs. Particularly for scientist-practitioner and clinical-scientist training programs, outcome data such as graduates' publications is an important aspect of the programs' continued self-study.
Stephenson, Rachel; You, Hong; McManus, Donald; Toth, Istvan
There is currently no vaccine available for human use for any parasitic infections, including the helminth disease, schistosomiasis. Despite many researchers working towards this goal, one of the focuses has been on identifying new antigenic targets. The bar to achieve protective efficacy in humans was set at a consistent induction of 40% protection or better by the World Health Organisation (WHO), and although this is a modest goal, it is yet to be reached with the six most promising schistosomiasis vaccine candidates (Sm28GST, IrV5, Sm14, paramyosin, TPI, and Sm23). Adjuvant selection has a large impact on the effectiveness of the vaccine, and the use of adjuvants to aid in the stimulation of the immune system is a critical step and a major variable affecting vaccine development. In addition to a comprehensive understanding of the immune system, level of protection and the desired immune response required, there is also a need for a standardised and effective adjuvant formulation. This review summarises the status of adjuvants that have been or are being employed in schistosomiasis vaccine development focusing on immunisation outcomes at preclinical and clinical stages. PMID:26344751
Mate, Sebastian; Köpcke, Felix; Toddenroth, Dennis; Martin, Marcus; Prokosch, Hans-Ulrich; Bürkle, Thomas; Ganslandt, Thomas
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.
Nance, M A; Myers, R H
Huntington's disease (HD) is an inherited neurodegenerative disorder. The mutation which causes the disease is an expansion in the number of repetitions of three nucleotides, C, A, and G in exon 1 of the huntingtin gene. The gene normally has 15 to 30 repeats and an expansion to 40 or more is associated with HD. HD usually has a mid-life onset, but a juvenile form, defined by onset of symptoms before the age of 21 years, is present in about 7% of HD cases. Juvenile HD is characterized by (1) transmission from an HD affected father, (2) an unusually large repeat size, usually of 60 or more units, and (3) unique clinical features, including rigidity and seizure disorder. Although juvenile onset is associated with a more severe neuropathological involvement, the neuropathological characteristics of juvenile HD are similar to those seen in the adult form in that the striatum bears the brunt of the illness. Clumps of protein, termed inclusion bodies, which stain positive for huntingtin and ubiquitin, are found primarily in the nucleus but also in the cytoplasm and axons in HD neurons. Research suggests that these inclusion bodies sequester a deleterious protein fragment and prolong cell life during the degenerative process of the disease.
Nardone, Raffaele; Höller, Yvonne; Tezzon, Frediano; Christova, Monica; Schwenker, Kerstin; Golaszewski, Stefan; Trinka, Eugen; Brigo, Francesco
The development of different methods of brain stimulation provides a promising therapeutic tool with potentially beneficial effects on subjects with impaired cognitive functions. We performed a systematic review of the studies published in the field of neurostimulation in Alzheimer's disease (AD), from basic research to clinical applications. The main methods of non-invasive brain stimulation are repetitive transcranial magnetic stimulation and transcranial direct current stimulation. Preliminary findings have suggested that both techniques can enhance performances on several cognitive functions impaired in AD. Another non-invasive emerging neuromodulatory approach, the transcranial electromagnetic treatment, was found to reverse cognitive impairment in AD transgenic mice and even improves cognitive performance in normal mice. Experimental studies suggest that high-frequency electromagnetic fields may be critically important in AD prevention and treatment through their action at mitochondrial level. Finally, the application of a widely known invasive technique, the deep brain stimulation (DBS), has increasingly been considered as a therapeutic option also for patients with AD; it has been demonstrated that DBS of fornix/hypothalamus and nucleus basalis of Meynert might improve or at least stabilize cognitive functioning in AD. Initial encouraging results provide support for continuing to investigate non-invasive and invasive brain stimulation approaches as an adjuvant treatment for AD patients.
Mate, Sebastian; Köpcke, Felix; Toddenroth, Dennis; Martin, Marcus; Prokosch, Hans-Ulrich
Data from the electronic medical record comprise numerous structured but uncoded ele-ments, which are not linked to standard terminologies. Reuse of such data for secondary research purposes has gained in importance recently. However, the identification of rele-vant 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. PMID:25588043
Hocher, Berthold; Adamski, Jerzy
Chronic kidney disease (CKD) has a high prevalence in the general population and is associated with high mortality; a need therefore exists for better biomarkers for diagnosis, monitoring of disease progression and therapy stratification. Moreover, very sensitive biomarkers are needed in drug development and clinical research to increase understanding of the efficacy and safety of potential and existing therapies. Metabolomics analyses can identify and quantify all metabolites present in a given sample, covering hundreds to thousands of metabolites. Sample preparation for metabolomics requires a very fast arrest of biochemical processes. Present key technologies for metabolomics are mass spectrometry and proton nuclear magnetic resonance spectroscopy, which require sophisticated biostatistic and bioinformatic data analyses. The use of metabolomics has been instrumental in identifying new biomarkers of CKD such as acylcarnitines, glycerolipids, dimethylarginines and metabolites of tryptophan, the citric acid cycle and the urea cycle. Biomarkers such as c-mannosyl tryptophan and pseudouridine have better performance in CKD stratification than does creatinine. Future challenges in metabolomics analyses are prospective studies and deconvolution of CKD biomarkers from those of other diseases such as metabolic syndrome, diabetes mellitus, inflammatory conditions, stress and cancer.
Martland, Timothy; Helen Cross, J
Many children with epilepsy experience it as part of a broader disability. The cause is often a developmental, genetic, or early acquired abnormality associated with learning difficulties and impairments in other systems. In addition, it has become increasingly recognized in recent years that even children with so-called idiopathic generalized epilepsies may have specific language or cognitive impairments. The combination of seizures and these factors can form a significant barrier to the child and family in social and emotional terms as well. A child's brain must mature and learn new skills; and a large proportion of childhood epilepsies directly impact on this. The degree of control of the epilepsy can affect cognitive progress; but for many children the underlying cause of the impairment is the significant factor. For all children, access to appropriate clinical, educational, and social services for assessment and therapy is paramount. Specific initiatives in the North West of the United Kingdom are attempting to address service and organizational issues. Current research projects are investigating the impairments children with epilepsy have in addition to having seizures.
Kappler, S.; Glasser, F.; Janssen, S.; Kraft, E.; Reinwand, M.
Recent publications emphasize the benefits of quantum-counting applied to the field of Computed Tomography (CT). We present a research prototype scanner with a CdTe-based quantum-counting detector and 20 cm field-of-view (FOV). As of today there is no direct converter material on the market able to operate reliably in the harsh high-flux regime of clinical CT scanners. Nevertheless, we investigate the CT imaging performance that could be expected with high-flux capable material. Therefore we chose pixel sizes of 0.05 mm2, a good compromise between high-flux counting ability and energy resolution. Every pixel is equipped with two energy threshold counters, enabling contrast-optimization and dual-energy scans. We present a first quantitative analysis of contrast measurements, in which we limit ourselves to a low-flux scenario. Using an Iodine-based contrast agent, we find 17% contrast enhancement at 120 kVp, compared to energy-integrating CT. In addition, the general dual-energy capability was confirmed in first measurements. We conclude our work by demonstrating good agreement of measurement results and detailed CT-system simulations.
Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research
Burt, Tal; Gupta, Yogendra K; Mehta, Nalin; Swamy, Nagendra; Sovani, Vishwas; Speers, Marjorie A
Like other emerging economies, India’s quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR −16.7%) amid regulatory concerns, activist protests, and sponsor departure. And although India accounts for 17.5% of the world’s population, it currently conducts only 1% of clinical trials. Indian and international experts and public stakeholders gathered for a 2-day conference in June 2013 in New Delhi to discuss the challenges facing clinical research in India and to explore solutions. The main themes discussed were ethical standards, regulatory oversight, and partnerships with public stakeholders. The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)—aimed at establishing responsible and ethical clinical research standards—and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)—aimed at informing and engaging the public in clinical research. The present article covers recent clinical research developments in India as well as associated expectations, challenges, and suggestions for future directions. AAHRPP and PARTAKE provide etiologically based solutions to protect, inform, and engage the public and medical research sponsors. PMID:25558428
Pincus, Harold Alan
Three related articles in this issue addressing clinical and translational (C/T) research suggest four simple questions about such research that should be considered by policy makers at a national level, by academic institutions, and by individual scientists: What, who, how, and why. The author of this commentary posits that ambiguity in answering these questions means that policy makers are not providing a clear target for institutions and researchers. The vagueness of the definitions may also obscure accountability with regard to assessing whether the rhetoric matches actions—for instance, what is the distribution of research activities and funding across the different phases of C/T research? Given the rapid evolution of new tools and methodologies in C/T research, it is important to consider each of these issues across the full developmental pathway of a C/T researcher. Overcoming these challenges and rapidly advancing along the pathway of creating knowledge to enhance the health of our communities and the nation depends on coherence and agreement by all players involved in C/T policy, funding, and participation. PMID:19318766
Ramseyer, Elizabeth A.
Every Fall, the Apache Point Observatory repeatedly images the skies near declination 0 degrees in a quest to see first light from distant supernovae. The Sloan Digital Sky Survey (SDSS) uses the data from these images to map the Universe. These data are made available on the internet for use by the public. While analyzing these images, we discovered the presence of a transient light source that subsequent analysis showed our ?mystery object? to be an asteroid. We present here the details of the analysis that allowed us to determine the identity of our ?mystery object.? Learn how you can access the SDSS database and make your own discovery!
Teo, Alan R
This article provides a brief account of the history of the development of training opportunities in clinical research in the United States. It highlights some developments in the clinical research enterprise since World War II and focuses examination on the involvement of the U.S. government and academic sector. Clinical research training is a relatively new academic field, and curricula in the design and conduct of clinical research have only emerged since the 1980s. The growing complexity of clinical trials and the emergence of evidence-based medicine in the last several decades created great demand for clinicians with knowledge of clinical epidemiology and biostatistics. Amidst alarm bells rung by physician-scientist leaders about the endangered species of clinical researchers, numerous proposals and solutions emerged to address these workforce and educational problems in the 1990s. Traditionally, physicians wishing to expand their education had to get a master's degree in public health or participate in unique programs such as the Robert Wood Johnson Clinical Scholars Program. Since the 1990s, the National Institutes of Health, through K awards, the Roadmap Initiative, and other funding mechanisms, has furnished tremendous support for the development of clinical research training opportunities from predoctoral immersion programs to degree-granting graduate programs. The author discusses key components of successful clinical research training programs and concludes with empirical recommendations for promoting careers in clinical research.
Crowley, William; Courtney, John; Jameson, Larry; Pardes, Herbert; Moskowitz, Jay; Orringer, Eugene; Rubenstein, Arthur; Wood, Alastair; Rettig, Richard; Ausiello, Dennis; Brenner, David; Collins, Francis; Elias, Jack; Greene, Warner; Horowitz, Ralph; Jameson, Larry; Kieff, Elliott; Thompson, Craig; Swain, Judith L
As representatives of 50 leading academic medical centers focusing on clinical research and many of academic medicine's scientific leaders, the Clinical Research Forum and Association of American Physicians disagree with the JCI's recent editorials on the NIH Roadmap, Elias Zerhouni's leadership, and the future directions of biomedical research.
Charlton, Rachel; Snowball, Julia; Sammon, Cormac; de Vries, Corinne
Medicine use during pregnancy is common; however the safety of medicine use during pregnancy is largely unknown when a medicine comes to market. Electronic healthcare databases, including the Clinical Practice Research Datalink (CPRD), are increasingly being used for post-marketing surveillance in this field. The CPRD contains anonymised, longitudinal medical records routinely collected in primary care. Using CPRD data it is possible to identify medical records indicative of pregnancy, including pregnancy losses. Data on prescriptions issued can be used to determine maternal exposure and for about 80% of pregnancies it is possible to link the mother's medical record to the medical record of the child. Data in the medical records of the mother and child can then be used to identify adverse pregnancy outcomes, including congenital malformations. This paper describes some of the complexities involved in using CPRD data for pregnancy related research and discusses some of its strengths and limitations.
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)
Mark, A L; Kelch, R P
There is national alarm about a decline in the number of clinician scientists. Most of the proposed solutions have focused on housestaff and junior faculty. We propose a new national program for training medical students in clinical research. This program, coined "Clinician Scientist Training Program" (CSTP), would consist of a combined degree program in medicine (MD) and clinical research (eg, masters in translational research or masters in clinical epidemiology). Students could enroll in the program at any stage during medical school. After 3 years of medical school, students would spend at least 2 years in a combined didactic and mentored clinical research training program and then complete medical school. Students could elect to pursue more prolonged clinical research training toward a combined PhD and MD. The CSTP is designed to meet six critical challenges: 1) engage students early in clinical research training; 2) provide a didactic clinical research curriculum; 3) expose students to several years of mentored clinical research training; 4) promote debt prevention by providing tuition payments during medical education and a stipend during clinical research training; 5) facilitate prolonged exposure to a community of peers and mentors in a program with national and institutional identity and respect; and 6) permit enrollment in the program as students enter medical school or at any stage during medical school. If the success of the Medical Scientist Training Program in training medical students in basic research is a guide, the CSTP could become a linchpin for training future generations of clinician scientists.
Repetto, Lazzaro; Luciani, Andrea
showed a good sensibility (87.3%) but a low specificity (62%) with respect to CGA for the diagnosis of patients with disabilities. Overcash et al. proposed an abbreviated form of CGA using a reduced number of items of ADL, IADL, MMSE and GDS. There was a good correlation between complete and reduced scales (coefficient of correlation 0.8). G8 is a screening tool composed of 8 questions that explore functional, cognitive and nutritional status. The score with the best equilibrium between sensibility and specificity was 14 (sensibility 85% and specificity 65%). In the first observational trial age, hystotype, chemotherapy dose, haemoglobin (man: 11 g/dL; women: 10 g/dL), creatinine clearance less than 34 mL/min (Jelliffe formula), earing problems, at least a fall in the last six months, walking problems, low social activity, were related to a major risk of toxicity; in another trial IADL, diastolic blood pressure, LDH and MAX2 index were predictive of haematological toxicity, while performance status, Mini-Mental Status score, Mini-Nutritional Assessment (MNA) score and MAX2 index were predictive of non haematological toxicity. Based on these parameters a 0-2 score was developed. A recent "position article" of EORTC (European organization for Research and Treatment of Cancer) and SIOG analyzed the pro and the contra of the use of some indicators in elderly patients. The overall survival (OS) frequently used in classical clinical trial could give wrong messages as there are some competitive risks of death in elderly patients. Another important indicator is the disease specific survival (DSS). Concerning the design of clinical trials, a possible strategy is to enrol elderly patients without upper age limit and to plan stratification. An interesting trial design is the so called "extended trial" that allow to re-open the arm of a trial in which a too low number of older patients was enrolled.
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.
A funding opportunity in support of the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) seeks to prospectively procure tumor samples, collected for proteomics investigation.
Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D
A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information.
Richesson, Rachel L; Nadkarni, Prakash
Case report forms (CRFs) are used for structured-data collection in clinical research studies. Existing CRF-related standards encompass structural features of forms and data items, content standards, and specifications for using terminologies. This paper reviews existing standards and discusses their current limitations. Because clinical research is highly protocol-specific, forms-development processes are more easily standardized than is CRF content. Tools that support retrieval and reuse of existing items will enable standards adoption in clinical research applications. Such tools will depend upon formal relationships between items and terminological standards. Future standards adoption will depend upon standardized approaches for bridging generic structural standards and domain-specific content standards. Clinical research informatics can help define tools requirements in terms of workflow support for research activities, reconcile the perspectives of varied clinical research stakeholders, and coordinate standards efforts toward interoperability across healthcare and research data collection.
Li, Zuofeng; Wen, Jingran; Zhang, Xiaoyan; Wu, Chunxiao; Li, Zuogao; Liu, Lei
Aim to ease the secondary use of clinical data in clinical research, we introduce a metadata driven web-based clinical data management system named ClinData Express. ClinData Express is made up of two parts: 1) m-designer, a standalone software for metadata definition; 2) a web based data warehouse system for data management. With ClinData Express, what the researchers need to do is to define the metadata and data model in the m-designer. The web interface for data collection and specific database for data storage will be automatically generated. The standards used in the system and the data export modular make sure of the data reuse. The system has been tested on seven disease-data collection in Chinese and one form from dbGap. The flexibility of system makes its great potential usage in clinical research. The system is available at http://code.google.com/p/clindataexpress.
Celli, Fabrizio; Keizer, Johannes; Jaques, Yves; Konstantopoulos, Stasinos; Vudragović, Dušan
The social media revolution is having a dramatic effect on the world of scientific publication. Scientists now publish their research interests, theories and outcomes across numerous channels, including personal blogs and other thematic web spaces where ideas, activities and partial results are discussed. Accordingly, information systems that facilitate access to scientific literature must learn to cope with this valuable and varied data, evolving to make this research easily discoverable and available to end users. In this paper we describe the incremental process of discovering web resources in the domain of agricultural science and technology. Making use of Linked Open Data methodologies, we interlink a wide array of custom-crawled resources with the AGRIS bibliographic database in order to enrich the user experience of the AGRIS website. We also discuss the SemaGrow Stack, a query federation and data integration infrastructure used to estimate the semantic distance between crawled web resources and AGRIS. PMID:26834982
Regulatory advances in proteomics will be taking center stage at a Symposia scheduled to occur at the 2011 American Association for Clinical Chemistry (AACC) Annual Meeting. The symposium entitled "Enabling Translational Proteomics with NCI's Clinical Proteomic Technologies for Cancer" is scheduled for July 25, 2011 at AACC's annual Meeting.
Zhang, Li; Zhang, Junhua; Chen, Jing; Xing, Dongmei; Wang, Jiaying
Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards. PMID:24312133
Rothan-Tondeur, Monique; Courcier, Soizic; Béhier, Jehan-Michel; Leblanc, Judith; Peoch, Nadia; Lefort, Marie-Claude; Barthélémy, Philippe; Bassompierre, François; Bilbault, Pascal; Déal, Cécile; Diebolt, Vincent; Fraleux, Michèle; François, Bruno; Gambotti, Laetitia; Lévy-Marchal, Claire; Misse, Christophe; Roussel, Christophe; Sibenaler, Claire; Simon, Tabassome; Tavernier, Blanche; Thoby, Frédérique
Clinical research is of major importance to today's society, as scientific evidence is increasingly demanded as a basis for progress, whether this involves developing new healthcare products, improving clinical practice and care protocols or progress in prevention. Clinical research therefore requires professionals who are both experienced and increasingly well trained. Against this background, allied health professionals are becoming involved more and more, both as team members supporting clinical research projects and as managers or coordinators of projects in their own field. Clinical research activities provide an ideal opportunity for continuing professional development. All of this means that the professional skills of the allied health professions and clinical research support professions must be enhanced, their role promoted in the context of lecturer status and in the longer term, their status recognised by the supervisory authorities.
Nishikawa, Takashi; Motter, Adilson E.
To understand the formation, evolution, and function of complex systems, it is crucial to understand the internal organization of their interaction networks. Partly due to the impossibility of visualizing large complex networks, resolving network structure remains a challenging problem. Here we overcome this difficulty by combining the visual pattern recognition ability of humans with the high processing speed of computers to develop an exploratory method for discovering groups of nodes characterized by common network properties, including but not limited to communities of densely connected nodes. Without any prior information about the nature of the groups, the method simultaneously identifies the number of groups, the group assignment, and the properties that define these groups. The results of applying our method to real networks suggest the possibility that most group structures lurk undiscovered in the fast-growing inventory of social, biological, and technological networks of scientific interest.
Dennis, Karen E.
Increasing numbers of hospitals and medical centers employ clinical nurse researchers. Nursing doctoral programs can prepare graduates for this role with courses in philosophy and ethics; research methods, statistics, and measurement; grantsmanship; and information dissemination. (SK)
Structural equation modeling (SEM) has been widely used in economics, sociology and behavioral science. However, its use in clinical medicine is quite limited, probably due to technical difficulties. Because SEM is particularly suitable for analysis of complex relationships among observed variables, it must have potential applications to clinical medicine. The article introduces basic ideas of SEM in the context of clinical medicine. A simulated dataset is employed to show how to do model specification, model fit, visualization and assessment of goodness-of-fit. The first example fits a SEM with continuous outcome variable using sem() function, and the second explores the binary outcome variable using lavaan() function. PMID:28361067
Gall, W; Eigenbauer, E; Rasoul-Rockenschaub, S
Computerized clinical forms are subject to a wide variety of different requirements. They have to allow detailed documentation and must be user-friendly. State-of-the-art applications for design permit clinicians themselves to create their own forms as needed, with the various variables presented in different ways depending on their intended use. Often, however, only aspects of clinical documentation are considered, with no thought being given to subsequent data retrieval. This article presents guidelines for the retrieval-oriented design of clinical forms. It discusses where anticipatory measures for structuring forms are easier to accomplish than complex data linkage at the time of retrieval and analysis.
The article discusses the key findings in recent research dealing narrative abilities in children with and without language implications. The implications of research findings for narrative assessment and intervention are discussed.
Pramesh, C S; Badwe, R A
The Indian Council of Medical Research and the Central Drugs Standards Control Organization of the Directorate General of Health Services of the Ministry of Health and Family Welfare' draft guidelines for compensation of research-related injury have evoked strong responses from the clinical research community. All stakeholders, including academic researchers, teachers in medical colleges, the pharmaceutical industry and even members of Institutional Review Boards and Ethics Committees have expressed grave reservations about several clauses in the guidelines. Moreover, these two guidelines differ from each other in important areas, reiterating that more thought and discussion is necessary to refine the guidelines. We present an academic researcher's perspective of the guidelines and our views on how they will affect clinical research in the country. The paper covers the types of research-related injury that are entitled for compensation, controversies on whether injury resulting from standard care should be entitled for compensation, whether causality needs to be established as a prerequisite for eligibility for compensation and whether all forms of research should have mandatory provision for compensation. We also put forward the potential dangers of such recommendations, which could potentially be inducement for patients to participate in clinical research. Finally, we raise the philosophical issue of infringement of an individual's fundamental rights regarding what research he/she wishes to participate in. While these points are based on several formal and informal discussions with stakeholders from various fields of clinical research, the views expressed are the authors' own personal thoughts.
The NCI’s Clinical Proteomic Technologies for Cancer (CPTC) initiative is focused on developing a better understanding of cancer biology through the proteomic interrogation of genomically characterized tumors from sources such as The Cancer Genome Atlas.
The National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (NCI-CPTAC) has recently begun the proteomic interrogation of genomically-characterized tumors from The Cancer Genome Atlas.
Talavera, Juan O; Rivas-Ruiz, Rodolfo
The quality of information obtained in accordance to research design is integrated to the revision structured in relation to the causality model, used in the article "Reduction in the Incidence of Nosocomial Pneumonia Poststroke by Using the 'Turn-mob' Program", which corresponds to a clinical trial design. Points to identify and analyze are ethical issues in order to safeguard the security and respect for patients, randomization that seek to create basal homogeneous groups, subjects with the same probability of receiving any of the maneuvers in comparison, with the same pre maneuver probability of adherence, and which facilitate the blinding of outcome measurement and the distribution between groups of subjects with the same probability of leaving the study for reasons beyond the maneuvers. Other aspects are the relativity of comparison, the blinding of the maneuver, the parallel application of comparative maneuver, early stopping, and analysis according to the degree of adherence. The analysis in accordance with the design is complementary, since it is done based on the architectural model of causality, and the statistical and clinical relevance consideration.
Sperisen, Peter; Cominetti, Ornella; Martin, François-Pierre J.
Systems biology is an important approach for deciphering the complex processes in health maintenance and the etiology of metabolic diseases. Such integrative methodologies will help better understand the molecular mechanisms involved in growth and development throughout childhood, and consequently will result in new insights about metabolic and nutritional requirements of infants, children and adults. To achieve this, a better understanding of the physiological processes at anthropometric, cellular and molecular level for any given individual is needed. In this respect, novel omics technologies in combination with sophisticated data modeling techniques are key. Due to the highly complex network of influential factors determining individual trajectories, it becomes imperative to develop proper tools and solutions that will comprehensively model biological information related to growth and maturation of our body functions. The aim of this review and perspective is to evaluate, succinctly, promising data analysis approaches to enable data integration for clinical research, with an emphasis on the longitudinal component. Approaches based on empirical and mechanistic modeling of omics data are essential to leverage findings from high dimensional omics datasets and enable biological interpretation and clinical translation. On the one hand, empirical methods, which provide quantitative descriptions of patterns in the data, are mostly used for exploring and mining datasets. On the other hand, mechanistic models are based on an understanding of the behavior of a system's components and condense information about the known functions, allowing robust and reliable analyses to be performed by bioinformatics pipelines and similar tools. Herein, we will illustrate current examples, challenges and perspectives in the applications of empirical and mechanistic modeling in the context of childhood metabolic health research. PMID:26301225
Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben MW; Fregni, Felipe
The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008–2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background. PMID:25878518
Murphy, Shawn N; Dubey, Anil; Embi, Peter J; Harris, Paul A; Richter, Brent G; Turisco, Fran; Weber, Griffin M; Tcheng, James E; Keogh, Diane
Information technology (IT) to support clinical research has steadily grown over the past 10 years. Many new applications at the enterprise level are available to assist with the numerous tasks necessary in performing clinical research. However, it is not clear how rapidly this technology is being adopted or whether it is making an impact upon how clinical research is being performed. The Clinical Research Forum's IT Roundtable performed a survey of 17 representative academic medical centers (AMCs) to understand the adoption rate and implementation strategies within this field. The results were compared with similar surveys from 4 and 6 years ago. We found the adoption rate for four prominent areas of IT-supported clinical research had increased remarkably, specifically regulatory compliance, electronic data capture for clinical trials, data repositories for secondary use of clinical data, and infrastructure for supporting collaboration. Adoption of other areas of clinical research IT was more irregular with wider differences between AMCs. These differences appeared to be partially due to a set of openly available applications that have emerged to occupy an important place in the landscape of clinical research enterprise-level support at AMC's.
Parker, Robert B; Ellingrod, Vicki; DiPiro, Joseph T; Bauman, Jerry L; Blouin, Robert A; Welage, Lynda S
Developing clinical pharmacists' research skills and their ability to compete for extramural funding is an important component of the American College of Clinical Pharmacy's (ACCP) vision for pharmacists to play a prominent role in generating the new knowledge used to guide patient pharmacotherapy. Given the recent emphasis on clinical/translational research at the National Institutes of Health (NIH) and the key role of drug therapy in the management of many diseases, there is an unprecedented opportunity for the profession to contribute to this enterprise. A crucial question facing the profession is whether we can generate enough appropriately trained scientists to take advantage of these opportunities to generate the new knowledge to advance drug therapy. Since the 2009 publication of the ACCP Research Affairs Committee editorial recommending the Ph.D. degree (as opposed to fellowship training) as the optimal method for preparing pharmacists as clinical/translational scientists, significant changes have occurred in the economic, professional, political, and research environments. As a result, the 2012 ACCP Research Affairs Committee was charged with reexamining the college's position on training clinical pharmacy scientists in the context of these substantial environmental changes. In this commentary, the potential impact of these changes on opportunities for pharmacists in clinical/translational research are discussed as are strategies for ACCP, colleges of pharmacy, and the profession to increase the number and impact of clinical pharmacy scientists. Failure of our profession to take advantage of these opportunities risks our ability to contribute substantively to the biomedical research enterprise and ultimately improve the pharmacotherapy of our patients.
Florida State Dept. of Education, Tallahassee. Technical and Health Occupations Education Section.
GUIDELINES FOR ORGANIZING AND OPERATING A DENTAL RESEARCH CLINIC WERE DEVELOPED BY THE DIVISION OF VOCATIONAL, TECHNICAL, AND ADULT EDUCATION, THE FLORIDA DENTAL SOCIETY'S SPECIAL COMMITTEE ON EDUCATION OF THE DENTAL ASSISTANT, AND OTHER DENTISTS WORKING CLOSELY WITH DENTAL ASSISTANT PROGRAMS. THE PURPOSES OF THE DENTAL RESEARCH CLINICS ARE TO…
The Visual Impairment/Intracranial Pressure (VIIP) Research and Clinical Advisory Panel convened on December 1, 2014 at the ISS Conference Facility in Houston. The panel members were provided updates to the current clinical cases and treatment plans along with the latest research activities (http://humanresearchroadmap.nasa.gov/Risks/?i=105) and preliminary study results. The following is a summary of this meeting.
Mason, Susan E.
Historically, African Americans have resisted participation in clinical trials and other research projects because of distrust of the mostly white research establishment. Although there are legitimate reasons for refusing to join clinical trials, most notably the abuses of the Tuskegee Syphilis Study, African Americans may be passing up…
DiBiaggio, John A.
Suggestions are made for reducing tension between clinical practice and basic research segments of pharmacy: develop mutual respect among all faculty segments, combine research efforts, modify the reward system for greater equity, increase physical proximity, share experiences through clinics and forums, and combine realism with tradition. (MSE)
Bragg, Elizabeth J.; Meganathan, Karthikeyan; Shay, Kenneth; Gilman, Stuart C.; Zeiss, Robert A.; Hettler, Debbie L.
The education mission of the Department of Veterans Affairs (VA) is to train health professionals to benefit VA and the United States. One approach for achieving that mission, along with VA's research and clinical missions, was the establishment of Geriatric Research, Education and Clinical Centers (GRECCs) in 1975. These were developed at VA…
Allen, Alisha; Parikh, Gunjan; McPhaul, Michael J
The second annual national meeting of the Doris Duke Charitable Foundation Clinical Research Fellowship for Medical Students program was held June 24 to 26, 2003, at Cold Spring Harbor Laboratory near Long Island Sound. This 3-day meeting offered an opportunity for 63 of the 2002 Doris Duke clinical research fellows, program directors, administrators, and invited physician-scientists to present and share their research with one another in an informal, inspiring setting at an institution with a history that mirrors the development of modern American medical research. Following a keynote lecture by Dr. Kenneth Davis, dean of the Mount Sinai School of Medicine, six physician-scientists representing different areas of clinical research presented their work. Oral and poster presentations by the Doris Duke fellows of their research were interspersed throughout the meeting and comprised its central focus. The fellows' research spanned a broad spectrum of clinical research from studies translating basic research findings to those addressing clinical questions to epidemiologic and health outcomes studies. The meeting culminated in a forum entitled "'Where Do We Go from Here?' Residency Selection and Further Research Training in Pursuit of a Career as a Clinician-Scientist," which was moderated by this year's clinical research fellow national program leader, Dr. Allyn L. Mark. The meeting celebrated the accomplishments of these talented medical students during their fellowship year and, it is hoped, instilled in them awareness that their continued efforts are important to the future progress of medicine.
Branch, Robert; Chester, Ann
We propose a novel, untapped opportunity, challenging cultural and man-power barriers to transferring advances in biomedical science knowledge that will improve community health care (Type II Clinical Translational Research) in a medically underserved community. We describe a pilot model in which adolescents apply principles of Community-Based Participatory Research (CBPR) at the epicenter of the obesity diabetes epidemic in rural Appalachia in West Virginia. The model invites minority, financially disadvantaged, and educationally disadvantaged adolescents to become educated on ethics, then provides infrastructure to support study design and conduct of CBPR. This experience demonstrates that these adolescents can efficiently, with quality and integrity, reach into the most vulnerable of communities and their own families to show that the prevalence of obesity is at 50% and diabetes 10.4% (n = 989). Our experience illustrates the infrastructure requirements for this strategy to be successful and emphasizes the substantial benefit that could accrue if the model is successfully sustained. The benefit includes not only the translation of knowledge to influence community lifestyle behavior but also the creation of a pipeline of new biomedical scientists for the future. PMID:20443918
Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M.
A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, via and Investigational New Drug (IND) application, into early phase clinical trials. The roadmap describes four key areas; basic and preclinical research, resource development, translational research and good manufacturing practice (GMP), and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value using a model of the relevant disease. During resource development the appropriate specialists and the required expertise to bring this product into the clinic are identified (e.g., researchers, regulatory specialists, GMP manufacturing staff, clinicians, and clinical trials staff, etc.). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase the plan to translate the research product into a clinical grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States this is done by filing an IND application with the Food and Drug Administration. The NHLBI-funded Production Assistance for Cellular Therapies (PACT) program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five PACT facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly, and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. PMID:25484311
Martínez Castuera-Gómez, Carla; Talavera, Juan O
The increased quality in medical care may be immediately accomplished if clinical research is integrated into daily clinical practice. In the generation of medical knowledge are four steps: an unanswered question awakened from clinical practice, the critical analysis of specialized literature, the development of a research protocol, and, finally, the publication of outcomes. Decision making and continuous training are becoming part of an effective strategy of medical attention improvement.
Sheets, Rebecca L.; Rangavajhula, Vijaya; Pullen, Jeffrey K.; Butler, Chris; Mehra, Vijay; Shapiro, Stuart
The Division of AIDS Vaccine Research Program funds the discovery and development of HIV/AIDS vaccine candidates. Basic researchers, having discovered a potential vaccine in the laboratory, next want to take that candidate into the clinic to test the concept in humans, to see if it translates. Many of them have heard of “cGMP” and know that they are supposed to make a “GMP product” to take into the clinic, but often they are not very familiar with what “cGMP” means and why these good practices are so important. As members of the Vaccine Translational Research Branch, we frequently get asked “can’t we use the material we made in the lab in the clinic?” or “aren’t Phase 1 studies exempt from cGMP?” Over the years, we have had many experiences where researchers or their selected contract manufacturing organizations have not applied an appropriate degree of compliance with cGMP suitable for the clinical phase of development. We share some of these experiences and the lessons learned, along with explaining the importance of cGMP, just what cGMP means, and what they can assure, in an effort to de-mystify this subject and facilitate the rapid and safe translational development of HIV vaccines. PMID:25698494
Stoops, William W.; Rush, Craig R.
Stimulant use disorders are an unrelenting public health concern worldwide. Agonist replacement therapy is among the most effective strategies for managing substance use disorders including nicotine and opioid dependence. The present paper reviewed clinical data from human laboratory self-administration studies and clinical trials to determine whether agonist replacement therapy is a viable strategy for managing cocaine and/or amphetamine use disorders. The extant literature suggests that agonist replacement therapy may be effective for managing stimulant use disorders, however, the clinical selection of an agonist replacement medication likely needs to be based on the pharmacological mechanism of the medication and the stimulant abused by patients. Specifically, dopamine releasers appear most effective for reducing cocaine use whereas dopamine reuptake inhibitors appear most effective for reducing amphetamine use. PMID:23574440
Heller, Caren; de Melo-Martín, Inmaculada
Most agree that the recent decades-long boom in biomedical research discoveries has not had a sufficient effect on the public's health. To overcome some of the barriers to speeding clinical and translational (C/T) research, the National Institutes of Health has established the Institutional Clinical and Translational Science Award (CTSA). To explore whether the CTSA proposal addresses major C/T barriers and whether funded institutions offer adequate solutions, the authors reviewed the obstacles to C/T research described in the literature and examined the completeness of the solutions offered by the 12 initial CTSA awardees. Through an analysis of the literature, the authors categorized C/T barriers into three categories (research workforce, research operations, and organizational silos). They then analyzed each CTSA proposal regarding the types of programs offered to address these barriers. They found that, in general, institutions developed detailed programs to address research workforce and research operations barriers but had limited to no solutions for organizational silos. The authors suggest that differences in how barriers are addressed are consistent with the degree of control that CTSA centers have over these obstacles and solutions. They argue that although CTSA centers might have an important role in successfully addressing some of the barriers to C/T research, CTSA centers might ultimately have difficulties achieving their purported goal of facilitating and increasing the efficiency and speed of C/T research because of a lack of control over solutions to some important obstacles facing such research.
PhD, Greg Alexander; Staggers, Nancy
Human factors (HF) studies are increasingly important as technology infuses into clinical settings. No nursing research reviews exist in this area. The authors conducted a systematic review on designs of clinical technology, 34 articles with 50 studies met inclusion criteria. Findings were classified into three categories based on HF research goals. The majority of studies evaluated effectiveness of clinical design; efficiency was fewest. Current research ranges across many interface types examined with no apparent pattern or obvious rationale. Future research should expand types, settings, participants; integrate displays; and expand outcome variables. PMID:19707093
Yasuhara, Takao; Agari, Takashi; Kameda, Masahiro; Kondo, Akihiko; Kuramoto, Satoshi; Jing, Meng; Sasaki, Tatsuya; Toyoshima, Atsuhiko; Sasada, Susumu; Sato, Kenichiro; Shinko, Aiko; Wakamori, Takaaki; Okuma, Yu; Miyoshi, Yasuyuki; Tajiri, Naoki; Borlongan, Cesario V.; Date, Isao
Epilepsy is a chronic neurological disorder, which presents with various forms of seizures. Traditional treatments, including medication using antiepileptic drugs, remain the treatment of choice for epilepsy. Recent development in surgical techniques and approaches has improved treatment outcomes. However, several epileptic patients still suffer from intractable seizures despite the advent of the multimodality of therapies. In this article, we initially provide an overview of clinical presentation of epilepsy then describe clinically relevant animal models of epilepsy. Subsequently, we discuss the concepts of regenerative medicine including cell therapy, neuroprotective agents, and electrical stimulation, which are reviewed within the context of our data. PMID:24287913
Potential Applications of the National Institute of Mental Health's Research Domain Criteria (RDoC) to Clinical Psychiatric Practice: How RDoC Might Be Used in Assessment, Diagnostic Processes, Case Formulation, Treatment Planning, and Clinical Notes.
Yager, Joel; Feinstein, Robert E
Offering a new framework for understanding and studying basic dimensions of normal and abnormal human functioning and mental disorders, the National Institute of Mental Health (NIMH) has initiated the Research Domain Criteria (RDoC) project in which a series of higher order domains, representing major systems of emotion, cognition, motivation, and social behavior, and their constituent operationally defined constructs serve as organizing templates for further research and inquiry, eg, to discover validated biomarkers and endophenotypes. Cutting across traditional DSM diagnoses, the domains are defined as Negative Valence Systems, Positive Valence Systems, Cognitive Systems, Systems for Social Processes, and Arousal/Regulatory Systems. To inform educators, trainees, and practitioners about RDoC, alert them to potential practical applications, and encourage their broad exploration in clinical settings, this article reviews the RDoC domains and their subsystem constructs with regard to potential current clinical considerations and applications. We describe ways in which the RDoC domains and constructs offer transdiagnostic frameworks for complementing traditional practice; suggest clinical questions to help elucidate salient information; and, translating RDoC domains and constructs headings into clinically friendly language, offer a template for the psychiatric review of systems that can serve in clinical notes.
Qiu, Yang; Wang, ZhaoWei; Liu, YongXiang; Qi, Nan; Si, Jie; Xiang, Xue; Xia, XiaoLing; Hu, YuanYang; Zhou, Xi
Insects are a group of arthropods and the largest group of animals on Earth, with over one million species described to date. Like other life forms, insects suffer from viruses that cause disease and death. Viruses that are pathogenic to beneficial insects cause dramatic economic losses on agriculture. In contrast, viruses that are pathogenic to insect pests can be exploited as attractive biological control agents. All of these factors have led to an explosion in the amount of research into insect viruses in recent years, generating impressive quantities of information on the molecular and cellular biology of these viruses. Due to the wide variety of insect viruses, a better understanding of these viruses will expand our overall knowledge of their virology. Here, we review studies of several newly discovered RNA insect viruses in China.
Biospecimen Research Network Symposium brings together stakeholders including research investigators, clinicians, industry representatives, hospital administrators and patient advocates to discuss new developments in the field of biospecimen science that address the molecular changes that can occur during collection, processing, and storage of biospecimens.
Lau, Chuen-Yen; Swann, Edith M; Singh, Sagri; Kafaar, Zuhayr; Meissner, Helen I; Stansbury, James P
HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance.
Sakamoto, Yoshihiro; Kokudo, Norihiro; Kawaguchi, Yoshikuni; Akita, Keiichi
Precise clinical knowledge of liver anatomy is required to safely perform a hepatectomy, for both open and laparoscopic surgery. At the 19th meeting of the Japanese Research Society of Clinical Anatomy (JRSCA), we conducted special symposia on essential issues of liver surgery, such as the history of hepatic segmentation, the glissonean pedicle approach, application of 3-D imaging simulation and fluorescent imaging using indocyanine green solution, a variety of segmentectomies including caudate lobectomy, the associating liver partition and portal vein embolization for stage hepatectomy and harvesting liver grafts for living donor liver transplantation. The present review article provides useful information for liver surgeons and anatomic researchers. PMID:28275581
Vizoso, Hector; Lyskawa, Meg; Couey, Paul
The National Institutes of Health have developed a new organizational consortium through a funding mechanism called the Clinical and Translational Science Award. This program funds academic institutions to create a platform for research that expedites the development and delivery of new treatments through open interdisciplinary collaboration. As a result, the adult clinical research center at San Francisco General Hospital is now part of the Clinical and Translational Science Institute at the University of California San Francisco. Nurses on this research unit have begun to employ a standardized nursing care plan that focuses on the particular needs of the research participant, an advancement that if implemented nationwide among all adult clinical research centers will be of paramount importance in fostering a collaborative relationship within the new organizational structure. This standardized nursing care plan will provide research nurses with a tool that will enable them to provide safe and quality patient care.
Halstead, L.S.; Wiechers, D.O.
This book contains 32 selections. Some of the titles are: Late effects of Polio: Historical Perspectives; Sleep-Disordered Breathing as a Late Effect of Poliomyelitis; Clinical Subtypes, DNA Repair Efficiency, and Therapeutic Trials in the Post-Polio Syndromes; and Post-Polio Muscle Function.
Malhotra, A K; Zhang, J-P; Lencz, T
Pharmacogenetic/pharmacogenomic (PGx) approaches to psychopharmacology aim to identify clinically meaningful predictors of drug efficacy and/or side-effect burden. To date, however, PGx studies in psychiatry have not yielded compelling results, and clinical utilization of PGx testing in psychiatry is extremely limited. In this review, the authors provide a brief overview on the status of PGx studies in psychiatry, review the commercialization process for PGx tests and then discuss methodological considerations that may enhance the potential for clinically applicable PGx tests in psychiatry. The authors focus on design considerations that include increased ascertainment of subjects in the earliest phases of illness, discuss the advantages of drug-induced adverse events as phenotypes for examination and emphasize the importance of maximizing adherence to treatment in pharmacogenetic studies. Finally, the authors discuss unique aspects of pharmacogenetic studies that may distinguish them from studies of other complex traits. Taken together, these data provide insights into the design and methodological considerations that may enhance the potential for clinical utility of PGx studies.
The National Cancer Institute's Clinical Proteomic Tumor Analysis Consortium (CPTAC) and the NVIDIA Foundation are pleased to announce funding opportunities in the fight against cancer. Each organization has launched a request for proposals (RFP) that will collectively fund up to $2 million to help to develop a new generation of data-intensive scientific tools to find new ways to treat cancer.
The practice of individual assessment has been moving toward the empirically derived Cattell-Horn-Carroll (CHC) theory of intellectual ability, which offers a hierarchical taxonomy of cognitive abilities. Current assessment tools provide varying adherence to operationalizing CHC theory, making clinical inference difficult. Expert consensus…
Orecchia, Roberto; Krengli, Marco; Jereczek-Fossa, Barbara A; Franzetti, Silvia; Gerard, Jean Pierre
Clinical results obtained with hadrontherapy have been extremely positive for various tumours, with percentages of local control and survival higher than those ascribed to conventional radiotherapy. Most clinical data obtained with charged particles are related to protontherapy but the implementation of carbon ion therapy has demonstrated to be of great interest in the last decade. These results, accompanied by the new performances in accelerator technology and calculation systems of the delivered doses, have determined over the past years an increased interest for the development of hadrontherapy, with the construction of new centres provided with equipment entirely dedicated to clinical activity (LLUMC, Loma Linda and NPTC, Boston in USA, HIMAC-NIRS, Chiba, PROBEAT, Tsukuba, and Hyogo Beam Medical Centres in Japan). A revision of the clinical indications specifically focused on ion therapy is presented as well as the results obtained in the different centres. With hadrontherapy, it is finally possible to increase the spectrum of treatments allowing preserving the organ and its functionality, with positive impacts from a social and economic point of view.
Shariat, Shahrokh F.; Lotan, Yair; Vickers, Andrew; Karakiewicz, Pierre I.; Schmitz-Dräger, Bernd J.; Goebell, Peter J.; Malats, Nuria
Purpose To critically review and illustrate current methodologic and statistical considerations for bladder cancer biomarker discovery and evaluation. Methods Original, review, and methodological articles, and editorials were reviewed and summarized. Results Biomarkers may be useful at multiple stages of bladder cancer management: early detection, diagnosis, staging, prognosis, and treatment; however, few novel biomarkers are currently used in clinical practice. The reasons for this disjunction are manifold and reflect the long and difficult pathway from candidate biomarker discovery to clinical assay, and the lack of coherent and comprehensive processes (pipelines) for biomarker development. Conceptually, the development of new biomarkers should be a process that is similar to therapeutic drug evaluation - a highly regulated process with carefully regulated phases from discovery to human applications. In a further effort to address the pervasive problem of inadequacies in the design, analysis, and reporting of biomarker prognostic studies, a set of reporting recommendations are discussed. For example, biomarkers should provide unique information that adds to known clinical and pathologic information. Conventional multivariable analyses are not sufficient to demonstrate improved prediction of outcomes. Predictive models, including or excluding any new putative biomarker, needs to show clinically significant improvement of performance in order to claim any real benefit. Towards this end, proper model building, avoidance of overfitting, and external validation are crucial. In addition, it is important to choose appropriate performance measures dependent on outcome and prediction type and to avoid use of cut-points. Biomarkers providing a continuous score provide potentially more useful information than cut-points since risk fits a continuum model. Combination of complementary and independent biomarkers is likely to better capture the biologic potential of a tumor
González-Saldivar, Gerardo; Rodríguez-Gutiérrez, René; Viramontes-Madrid, José Luis; Salcido-Montenegro, Alejandro; Carlos-Reyna, Kevin Erick Gabriel; Treviño-Alvarez, Andrés Marcelo; Álvarez-Villalobos, Neri Alejandro; González-González, José Gerardo
Background There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials. Methods To assess the perception that 604 trial participants (cases) and 604 nonparticipants (controls) of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico. Results Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4%) than controls (50.7%) perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%). We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk (57% vs 33.3%). More cases (99.2%) than controls (77.5%) would recommend participating in a clinical trial, and 90% of cases would enroll in a clinical trial again. Conclusion Participation in clinical trials positively influences the perception that participants have about pharmaceutical clinical research when compared to nonparticipants. This information needs to be conveyed to clinicians, public health authorities, and general population to overcome misconceptions. PMID:27199549
Newington, Lisa; Metcalfe, Alison
Background Recruiting the desired number of research participants is frequently problematic with resulting financial and clinical implications. The views of individuals responsible for participant recruitment have not been previously reviewed. This systematic review and thematic meta-synthesis explores researchers’ and clinicians’ experiences and perceptions of recruiting participants to clinical research, with the aim of informing improved recruitment systems and strategies. Methods Studies published between January 1995 and May 2013 were identified from: Ovid MEDLINE, Ovid EMBASE, Ovid PSYCHINFO, ASSIA, British Nursing Index, Scopus, Web of Science, CINAHL and PubMed. Included studies were original peer reviewed research, with qualitative methodologies and an aim of exploring the views of clinicians and/or researchers on recruitment to clinical research. Studies discussing the recruitment of patients unable to give informed consent were excluded. The findings sections of the relevant studies were free coded to identify key concepts which were grouped into hierarchical themes. The quality of the identified studies was assessed and the relative contribution of each paper was checked to ensure individual studies did not dominate in any theme. Results Eighteen relevant papers were identified which examined the views of researchers and clinicians in 10 clinical specialties. Five main themes emerged: building a research community, securing resources, the nature of research, professional identities and recruitment strategies. The views of researchers and clinicians were similar, although the role of ‘researcher’ was inconsistently defined. Conclusions The general experience of recruiting participants to clinical research was one of competition and compromise. Competition arose over funding, staffing and participants, and between clinical and research responsibilities. Compromise was needed to create study designs that were acceptable to patients, clinicians and
Stevens, Patricia E; Pletsch, Pamela K
The purposes of this paper are to (a) discuss the troubled history of informed consent for research on women and its ramifications for women's participation in clinical trials; (b) interrogate current informed consent practices as to their accountability and justice in the treatment of women; and (c) recommend to nurse researchers and clinical nurses ways of improving the practice of informed consent in research with women.
Vixie, Graham; Barnes, Jason W.; Jackson, Brian; Wilson, Paul
We have discovered two temperate lakes on Titan using Cassini's Visual and Infrared Mapping Spectrometer (VIMS). Three key features help to identify these surface features as lakes: morphology, albedo, and specular reflection. The presence of lakes at the mid-latitudes mean liquid can accumulate and remain stable outside of the poles. We first identify a lake surface by looking for possible shorelines with a lacustrine morphology. Then, we apply a simple atmospheric correction that produces an approximate surface albedo. Next, we prepare cylindrical projection maps of the brightness of the sky as seen from any points on the surface to identify specular reflections. Our techniques can then be applied to other areas, such as Arrakis Planitia, to test for liquid. Currently, all the known lakes on Titan are concentrated at the poles. Lakes have been suggested in the tropic zone by Griffith et al. Our discovery of non-transient, temperate lakes has important implications for Titan's hydrologic cycle. Clouds have been recorded accumulating in the mid-latitudes and areas have been darkened by rainfall but later brightened after evaporation (Turtle et al. 2011). Stable temperate lakes would affect total rainfall, liquid accumulation, evaporation rates, and infiltration. Polaznik Macula (Figure 1) is a great candidate for lake filling, evaporation rates, and stability. References: Griffith, C., et al.: "Evidence for Lakes on Titan's Tropical Surface". AAS/Division for Planetary Sciences Meeting Abstracts #42, Vol. 42, pp. 1077, 2010. Turtle, E. P., et al.: "Rapid and Extensive Surface Changes Near Titan's Equator: Evidence of April Showers". Science, Vol. 331, pp. 1414-, 2011. Figure 1: Polaznik Macula is the large, dark area central to the figure. The encircled dark blue areas represent positively identified lake regions in the T66 flyby. The light blue areas represent lake candidates still under analysis. The green circle marks a non-lake surface feature enclosed by a
Escolar, Diana M; Henricson, Erik K; Pasquali, Livia; Gorni, Ksenija; Hoffman, Eric P
Progress in the development of rationally based therapies for Duchenne muscular dystrophy has been accelerated by encouraging multidisciplinary, multi-institutional collaboration between basic science and clinical investigators in the Cooperative International Research Group. We combined existing research efforts in pathophysiology by a gene expression profiling laboratory with the efforts of animal facilities capable of conducting high-throughput drug screening and toxicity testing to identify safe and effective drug compounds that target different parts of the pathophysiologic cascade in a genome-wide drug discovery approach. Simultaneously, we developed a clinical trial coordinating center and an international network of collaborating physicians and clinics where those drugs could be tested in large-scale clinical trials. We hope that by bringing together investigators at these facilities and providing the infrastructure to support their research, we can rapidly move new bench discoveries through animal model screening and into therapeutic testing in humans in a safe, timely and cost-effective setting.
Spitzer, E D; Pierce, G F; McDonald, J M
We describe a laboratory medicine residency training program that includes ongoing interaction with both clinical laboratories and clinical services as well as significant research experience. Laboratory medicine residents serve as on-call consultants in the interpretation of test results, design of testing strategies, and assurance of test quality. The consultative on-call beeper system was evaluated and is presented as an effective method of clinical pathology training that is well accepted by the clinical staff. The research component of the residency program is also described. Together, these components provide training in real-time clinical problem solving and prepare residents for the changing technological environment of the clinical laboratory. At the completion of the residency, the majority of the residents are qualified laboratory subspecialists and are also capable of running an independent research program.
Nørgaard, M; Johnsen, S P
In Denmark, the need for monitoring of clinical quality and patient safety with feedback to the clinical, administrative and political systems has resulted in the establishment of a network of more than 60 publicly financed nationwide clinical quality databases. Although primarily devoted to monitoring and improving quality of care, the potential of these databases as data sources in clinical research is increasingly being recognized. In this review, we describe these databases focusing on their use as data sources for clinical research, including their strengths and weaknesses as well as future concerns and opportunities. The research potential of the clinical quality databases is substantial but has so far only been explored to a limited extent. Efforts related to technical, legal and financial challenges are needed in order to take full advantage of this potential.
Societies in Latin America are not scientifically driven and therefore, the allocation of human and economic resources to research is meager, as a reflection of this as well as other cultural and economic realities.
As omics science moves forward, identifying methodologies and applications based on specific types of omic data, as well as their integration, becomes increasingly important as it provides new insights to be rapidly tested in basic or applied research.
Gibbons, Carly J.; Stirman, Shannon Wiltsey; Brown, Gregory K.; Beck, Aaron T.
Background High attrition rates in longitudinal research can limit study generalizability, threaten internal validity, and decrease statistical power. Research has demonstrated that there can be significant differences between participants who complete a research study and those who drop out prematurely, and that treatment outcomes may be dependent on retention in a treatment protocol. Aims The current paper describes the challenges encountered when implementing a randomized controlled trial of cognitive therapy for the prevention of suicide attempts and the solutions developed to overcome these problems. Methods Problems unique to suicide attempters are discussed, and strategies successfully implemented to boost retention rates are provided. Results The methods implemented appeared to increase retention rates in the randomized controlled trial. Conclusions Many steps can be taken to work with this difficult population, and researchers are encouraged to be as involved and flexible with participants as possible. PMID:20418211
CPTAC researchers partner with international labs to demonstrate the ability of Targeted mass spectrometry–based assays to reproducibly quantify Human proteins across labs, countries and continents in a recently published journal article.
Pullman, D; Hodgkinson, K
Despite a rapidly expanding literature on the issue of duty to warn at-risk relatives in the context of clinical genetic testing, little has been written on parallel issues with regard to the management of genetic research results. Some might view this lack as an indication that there is little to discuss in this regard. That is, standard practice is that data obtained through medical research should not be treated as though they are clinically relevant, and this standard should hold for genetic research as well. This paper challenges this conclusion and its underlying assumptions. We argue that the line between genetic research and clinical practice is often ambiguous. In some cases, research data gathered from a very small number of subjects could have immediate clinical implications. Hence, it is unethical for genetic researchers to absolve themselves of clinical responsibilities for research subjects and/or their families, on the grounds that the data were obtained for research purposes. Indeed, we argue that it could well be unethical to embark on some forms of genetic research unless advance arrangements have been made for genetic counseling and clinical follow-up. Furthermore, in some cases, it might be unethical to enroll subjects in studies if the subjects are unwilling to receive their individual results.
The Innovative Molecular Analysis Technologies (IMAT) program was established to support the development, technical maturation, and dissemination of novel and potentially transformative next-generation technologies through an approach of balanced but targeted innovation. In support of its mission, the IMAT program utilizes a variety of investigator-initiated research project grant mechanisms while retaining a strong commitment to diversity and to the training of scientists and clinicians in cross-cutting, research-enabling disciplines.
Chiuzan, Cody; West, Erin A; Duong, Jimmy; Cheung, Ken Y K; Einstein, Andrew J
Sample size calculation is an important element of research design that investigators need to consider in the planning stage of the study. Funding agencies and research review panels request a power analysis, for example, to determine the minimum number of subjects needed for an experiment to be informative. Calculating the right sample size is crucial to gaining accurate information and ensures that research resources are used efficiently and ethically. The simple question "How many subjects do I need?" does not always have a simple answer. Before calculating the sample size requirements, a researcher must address several aspects, such as purpose of the research (descriptive or comparative), type of samples (one or more groups), and data being collected (continuous or categorical). In this article, we describe some of the most frequent methods for calculating the sample size with examples from nuclear cardiology research, including for t tests, analysis of variance (ANOVA), non-parametric tests, correlation, Chi-squared tests, and survival analysis. For the ease of implementation, several examples are also illustrated via user-friendly free statistical software.
Bagatin, Ediléia; Miot, Helio A.
Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006