WorldWideScience

Sample records for clinical research study

  1. Nursing research. Components of a clinical research study.

    Science.gov (United States)

    Bargagliotti, L A

    1988-09-01

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

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

    Science.gov (United States)

    Johnson, S B

    2017-08-01

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

  3. Clinical Research

    DEFF Research Database (Denmark)

    Christensen, Irene

    2016-01-01

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

  4. Retention of minority participants in clinical research studies.

    Science.gov (United States)

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

    2005-04-01

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

  5. Legitimating Clinical Research in the Study of Organizational Culture.

    Science.gov (United States)

    Schein, Edgar H.

    1993-01-01

    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…

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

    Science.gov (United States)

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

    2017-09-18

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

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

    DEFF Research Database (Denmark)

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

    2000-01-01

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

  8. Clinical research informatics

    CERN Document Server

    Richesson, Rachel L

    2012-01-01

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

  9. Financial Conflicts of Interest Checklist 2010 for clinical research studies.

    Science.gov (United States)

    Rochon, Paula A; Hoey, John; Chan, An-Wen; Ferris, Lorraine E; Lexchin, Joel; Kalkar, Sunila R; Sekeres, Melanie; Wu, Wei; Van Laethem, Marleen; Gruneir, Andrea; Maskalyk, James; Streiner, David L; Gold, Jennifer; Taback, Nathan; Moher, David

    2010-01-01

    A conflict of interest is defined as "a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)" [Thompson DF. Understanding financial conflicts of interest. N Engl J Med 1993;329(8):573-576]. Because financial conflict of interest (fCOI) can occur at different stages of a study, and because it can be difficult for investigators to detect their own bias, particularly retrospectively, we sought to provide funders, journal editors and other stakeholders with a standardized tool that initiates detailed reporting of different aspects of fCOI when the study begins and continues that reporting throughout the study process to publication. We developed a checklist using a 3-phase process of pre-meeting item generation, a stakeholder meeting and post-meeting consolidation. External experts (n = 18), research team members (n = 12) and research staff members (n = 4) rated or reviewed items for some or all of the 7 major iterations. The resulting Financial Conflicts of Interest Checklist 2010 consists of 4 sections covering administrative, study, personal financial, and authorship information, which are divided into 6 modules and contain a total of 15 items and their related sub-items; it also includes a glossary of terms. The modules are designed to be completed by all investigators at different points over the course of the study, and updated information can be appended to the checklist when it is submitted to stakeholder groups for review. We invite comments and suggestions for improvement at http://www.openmedicine.ca/fcoichecklist and ask stakeholder groups to endorse the use of the checklist.

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

    NARCIS (Netherlands)

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

    2015-01-01

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

  11. Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71% were completed according to protocol, 128 (16% discontinued and 42 (5% are still ongoing; for 61 (8% there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55. Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48% protocols and in 205 (49% of the publications. In most published studies (339; 81% this information corresponded between protocol and publication. Most studies were published in English (367; 88%; some in German (25; 6% or both languages (27; 6%. The local investigators were listed as (co-authors in the publications corresponding to 259 (62% studies.Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care

  12. Nurse leaders' perceptions of the ethical recruitment of study subjects in clinical research.

    Science.gov (United States)

    Nurmi, Sanna-Maria; Pietilä, Anna-Maija; Kangasniemi, Mari; Halkoaho, Arja

    2015-11-01

    The aim of this study was to describe nurse leaders' perceptions of ethical recruitment in clinical research. Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues. Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis. Nurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture. Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained. The duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff. © 2014 John Wiley & Sons Ltd.

  13. CASE REPORT AND CLINICAL DATABASED RESEARCH STUDY ON MALARIA

    Directory of Open Access Journals (Sweden)

    Madhubhai M. Patel

    2010-03-01

    Full Text Available Malaria is endemic in Gujarat and the adjoining areas like many other parts of theIndia. Depending upon the environmental conditions different species of malarial parasiteare found in different areas. The present study was planned to see the pattern of malarialinfection diagnosed at B.J. Desai Trust Hospital, Kheda, Gujarat. Methods: Giemsastained thick and thin blood films of indoor and outdoor febrile patients sent to thelaboratory of B.J. Desai Trust Hospital, Kheda, Gujarat with a suspicion of malaria, wereexamined. Thick film was examined for the diagnosis of malaria while thin films wereseen to know the species. Results: Out of 1994 patients screened, 145 (7.2% were foundinfected. Plasmodium vivax was seen in the majority (72.47.2%. Plasmodium falciparumwas the second common species detected in 24.1 % cases. Mixed infection was seen in3.44% cases while Plasmodium malariae and ovale was not seen in any patient.Conclusion: Plasmodium vivax was the commonest type of malaria diagnosed at KhedaDistrict in Gujarat, during 2008- 2009.

  14. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study

    DEFF Research Database (Denmark)

    Bucuras, Viorel; Gopalakrishnam, Ganesh; Wolf, J Stuart

    2012-01-01

    The study compared characteristics and outcomes in patients with solitary and bilateral kidneys who were treated with percutaneous nephrolithotomy (PCNL) in the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study.......The study compared characteristics and outcomes in patients with solitary and bilateral kidneys who were treated with percutaneous nephrolithotomy (PCNL) in the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study....

  15. Clinical reasoning and its application to nursing: concepts and research studies.

    Science.gov (United States)

    Banning, Maggi

    2008-05-01

    Clinical reasoning may be defined as "the process of applying knowledge and expertise to a clinical situation to develop a solution" [Carr, S., 2004. A framework for understanding clinical reasoning in community nursing. J. Clin. Nursing 13 (7), 850-857]. Several forms of reasoning exist each has its own merits and uses. Reasoning involves the processes of cognition or thinking and metacognition. In nursing, clinical reasoning skills are an expected component of expert and competent practise. Nurse research studies have identified concepts, processes and thinking strategies that might underpin the clinical reasoning used by pre-registration nurses and experienced nurses. Much of the available research on reasoning is based on the use of the think aloud approach. Although this is a useful method, it is dependent on ability to describe and verbalise the reasoning process. More nursing research is needed to explore the clinical reasoning process. Investment in teaching and learning methods is needed to enhance clinical reasoning skills in nurses.

  16. Mentoring in Clinical-Translational Research: A Study of Participants in Master’s Degree Programs

    OpenAIRE

    McGinn, Aileen P; Lee, Linda S; Baez, Adriana; Zwanziger, Jack; Anderson, Karl E; Seely, Ellen W; Schoenbaum, Ellie

    2015-01-01

    Research projects in translational science are increasingly complex and require interdisciplinary collaborations. In the context of training translational researchers, this suggests that multiple mentors may be needed in different content areas. This study explored mentoring structure as it relates to perceived mentoring effectiveness and other characteristics of masters-level trainees in clinical-translational research training programs.

  17. A qualitative study on acceptable levels of risk for pregnant women in clinical research.

    Science.gov (United States)

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

    2017-05-15

    There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals' individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient

  18. Research Areas - Clinical Trials

    Science.gov (United States)

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

  19. Identifying the barriers to conducting outcomes research in integrative health care clinic settings - a qualitative study

    Directory of Open Access Journals (Sweden)

    Findlay-Reece Barbara

    2010-01-01

    Full Text Available Abstract Background Integrative health care (IHC is an interdisciplinary blending of conventional medicine and complementary and alternative medicine (CAM with the purpose of enhancing patients' health. In 2006, we designed a study to assess outcomes that are relevant to people using such care. However, we faced major challenges in conducting this study and hypothesized that this might be due to the lack of a research climate in these clinics. To investigate these challenges, we initiated a further study in 2008, to explore the reasons why IHC clinics are not conducting outcomes research and to identify strategies for conducting successful in-house outcomes research programs. The results of the latter study are reported here. Methods A total of 25 qualitative interviews were conducted with key participants from 19 IHC clinics across Canada. Basic content analysis was used to identify key themes from the transcribed interviews. Results Barriers identified by participants fell into four categories: organizational culture, organizational resources, organizational environment and logistical challenges. Cultural challenges relate to the philosophy of IHC, organizational leadership and practitioner attitudes and beliefs. Participants also identified significant issues relating to their organization's lack of resources such as funding, compensation, infrastructure and partnerships/linkages. Environmental challenges such as the nature of a clinic's patient population and logistical issues such as the actual implementation of a research program and the applicability of research data also posed challenges to the conduct of research. Embedded research leadership, integration of personal and professional values about research, alignment of research activities and clinical workflow processes are some of the factors identified by participants that support IHC clinics' ability to conduct outcomes research. Conclusions Assessing and enhancing the broader

  20. Accelerating translational research by clinically driven development of an informatics platform--a case study.

    Directory of Open Access Journals (Sweden)

    Imad Abugessaisa

    Full Text Available Translational medicine is becoming increasingly dependent upon data generated from health care, clinical research, and molecular investigations. This increasing rate of production and diversity in data has brought about several challenges, including the need to integrate fragmented databases, enable secondary use of patient clinical data from health care in clinical research, and to create information systems that clinicians and biomedical researchers can readily use. Our case study effectively integrates requirements from the clinical and biomedical researcher perspectives in a translational medicine setting. Our three principal achievements are (a a design of a user-friendly web-based system for management and integration of clinical and molecular databases, while adhering to proper de-identification and security measures; (b providing a real-world test of the system functionalities using clinical cohorts; and (c system integration with a clinical decision support system to demonstrate system interoperability. We engaged two active clinical cohorts, 747 psoriasis patients and 2001 rheumatoid arthritis patients, to demonstrate efficient query possibilities across the data sources, enable cohort stratification, extract variation in antibody patterns, study biomarker predictors of treatment response in RA patients, and to explore metabolic profiles of psoriasis patients. Finally, we demonstrated system interoperability by enabling integration with an established clinical decision support system in health care. To assure the usefulness and usability of the system, we followed two approaches. First, we created a graphical user interface supporting all user interactions. Secondly we carried out a system performance evaluation study where we measured the average response time in seconds for active users, http errors, and kilobits per second received and sent. The maximum response time was found to be 0.12 seconds; no server or client errors of any

  1. Clinical Research and Clinical Trials

    Science.gov (United States)

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

  2. [Relations between research and clinical care in co-management studies with mental health care users].

    Science.gov (United States)

    Palombini, Analice de Lima; Onocko-Campos, Rosana Teresa; Silveira, Marília; Gonçalves, Laura Lamas Martins; Zanchet, Lívia; Xavier, Maria Angélica Zamora; de Castro e Marques, Cecília

    2013-10-01

    This paper is derived from the experience of conducting research with mental health users (not about them, nor for them), analyzing aspects of a study in which different ways of structuring the relationship between clinical practice and research were put into play, thereby questioning the boundaries and ethical issues involved. The clinical practice and research fields that are dealt with are studied with the input of authors who, on the basis of institutional analysis, propose the idea of interventional research, and in the context of public health, revert to the concept of broadened clinical care. The relationship between these two terms - interventional research and broadened clinical care - is based on the notion of subjectivity that operates within the scope of public health and which culminates in the concept of autonomy. Lastly, co-management is proposed as a strategy based on which the different actors involved in conducting research and exercising clinical care can collectively build working principles that are both therapeutic and ethical.

  3. Unique roles of SPET brain imaging in clinical and research studies

    International Nuclear Information System (INIS)

    Seibyl, J.; Jennings, D.; Tabamo, R.; Marek, K.

    2005-01-01

    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 SPEC 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 neoroprotective 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 bio markers 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 of 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

  4. Participants' perception of pharmaceutical clinical research: a cross-sectional controlled study

    Directory of Open Access Journals (Sweden)

    González-Saldivar G

    2016-04-01

    Full Text Available Gerardo González-Saldivar,1 René Rodríguez-Gutiérrez,2 José Luis Viramontes-Madrid,3 Alejandro Salcido-Montenegro,2 Kevin Erick Gabriel Carlos-Reyna,2 Andrés Marcelo Treviño-Alvarez,2 Neri Alejandro Álvarez-Villalobos,4 José Gerardo González-González2 1Ophthalmology Department, 2Endocrinology Division, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, 3Instituto Nacional de Salud Pública, Cuernavaca, Morelos, 4Medical Statistics Department, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico 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

  5. The clinical research office of the endourological society percutaneous nephrolithotomy global study

    DEFF Research Database (Denmark)

    Desai, Mahesh; De Lisa, Antonello; Turna, Burak

    2011-01-01

    PURPOSE: The study compared characteristics and outcomes in patients with staghorn or nonstaghorn stones who were treated with percutaneous nephrolithotomy (PCNL) within the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study. PATIENTS AND METHODS: Data over a 1-year ...

  6. Developing an understanding of research-based nursing pedagogy among clinical instructors: a qualitative study.

    Science.gov (United States)

    Zakari, Nazik M A; Hamadi, Hanadi Y; Salem, Olfat

    2014-11-01

    Effective instruction is imperative to the learning process of clinical nursing instructors. Faculty members are required to provide high-quality teaching and training by using new ways of teaching pedagogical methods to clinical instructors, which have transformed pedagogies from an exclusive clinical model to a holistic model. The purpose of this study was to explore clinical instructors' use of planning, implementation, feedback loops, and reflection frameworks to apply research-based teaching and to examine the pedagogy used during field experience. Data for the qualitative study were obtained from twenty purposefully sampled clinical teachers (n=20) via lists of questioned instructional practices and discussions, semi-structured interviews, observational notes, field notes, and written reflections. Data were analyzed by using a triangulation method to ensure trustworthiness, credibility, and reliability. Three main themes emerged regarding the use of research-based teaching strategies: the need for learning about research-based pedagogy, support mechanisms to implement innovative teaching strategies, and transitioning from nursing student to nursing clinical instructors. It has been well documented that the nursing profession faces a serious shortage of nursing faculty, impacting the quality of clinical teaching. Developing clinical instructor programs to give students opportunities to select instructor pathways, focusing on knowledge promoting critical thinking and life-long professional development, is essential. Nursing colleges must collaborate by using a partnership model to achieve competency in planning, implementation, feedback loops, and reflection. Applying research-based clinical teaching requires the development of programs that integrate low-fidelity simulation and assisted instruction through the use of computers in Nursing Colleges. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Clinical studies of the Research Committee on Intractable Vasculitides, the Ministry of Health, Labour and Welfare of Japan.

    Science.gov (United States)

    Makino, Hirofumi; Sada, Ken-Ei

    2013-10-01

    In Japan, the Research Committee on Intractable Vasculitides, supported by the Ministry of Health, Labour and Welfare, has been promoting basic and clinical research on vasculitis since 1972. The present Research Committee on Intractable Vasculitides comprises 4 subcommittees under the direction of a Principal Investigator: Basic and Pathological Research Subcommittee, Clinical Research Subcommittee of Small and Medium-sized Vessel Vasculitis, Clinical Research Subcommittee of Large-sized Vessel Vasculitis, and International Cooperation Research Subcommittee. Since 2008, 9 nationwide clinical studies for vasculitis have been conducted and 8 clinical and basic studies are in progress.

  8. Motives for participating in a clinical research trial: a pilot study in Brazil

    Directory of Open Access Journals (Sweden)

    Nappo Solange A

    2013-01-01

    Full Text Available Abstract Background In the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil. Methods Mixed-methods research was used (a qualitative-quantitative approach. A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing. Results The motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS. However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study. Conclusions The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study

  9. Motives for participating in a clinical research trial: a pilot study in Brazil.

    Science.gov (United States)

    Nappo, Solange A; Iafrate, Giovanna B; Sanchez, Zila M

    2013-01-10

    In the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil. Mixed-methods research was used (a qualitative-quantitative approach). A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing. The motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS). However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study. The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study participants had an integral understanding of the ICS is not clear.

  10. Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study.

    Science.gov (United States)

    Mamotte, Nicole; Wassenaar, Douglas

    2017-09-01

    Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

  11. Current Research Studies

    Science.gov (United States)

    ... Success Home > Explore Research > Current Research Studies Current Research Studies Email Print + Share The Crohn’s & Colitis Foundation ... conducted online. Learn more about IBD Partners. Clinical Research Alliance The Clinical Research Alliance is a network ...

  12. [Role of multicenter study groups for clinical research in hematology and oncology].

    Science.gov (United States)

    Gökbuget, N; Hoelzer, D

    2009-04-01

    During the past 25 years a highly effective infrastructure for clinical trials was developed in hematology. Following initial funding by the BMFT (Ministry for Research and Technology) a number of large multicenter study groups for leukemia and lymphoma were developed. Treatment results from these studies often represent the"gold standard". However, since no standard therapy is defined for these diseases, the study groups aim to treat all patients within treatment optimization trials (TOT) to combine research and care. They contribute considerably to quality control in therapy and diagnostics, e.g., by establishing central reference laboratories. The regulatory requirements for clinical trials were extended considerably after the activation of the 12th drug law and TOTs now have to fulfill requirements similar to registration trials in the pharmaceutical industry. Due to the considerable bureaucratic effort and increased costs, only few large multicenter trials could thereafter be initiated and a substantial disadvantage for independent academic research becomes clearly evident.

  13. 78 FR 70102 - Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation...

    Science.gov (United States)

    2013-11-22

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Development Officer through the Director of the Clinical Science Research and Development Service on the...

  14. 78 FR 41198 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2013-07-09

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and.... The Committee advises the Chief Research and Development Officer through the Director of the Clinical...

  15. 77 FR 72438 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2012-12-05

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... through the Director of the Clinical Science Research and Development Service on the relevance and...

  16. 78 FR 53015 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2013-08-27

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and...

  17. Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

    Science.gov (United States)

    Scrivani, Peter V; Erb, Hollis N

    2013-01-01

    High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

  18. Recurrent Laryngeal Nerve Palsy After Cervical Spine Surgery: A Multicenter AOSpine Clinical Research Network Study

    OpenAIRE

    Gokaslan, Ziya L.; Bydon, Mohamad; De la Garza-Ramos, Rafael; Smith, Zachary A.; Hsu, Wellington K.; Qureshi, Sheeraz A.; Cho, Samuel K.; Baird, Evan O.; Mroz, Thomas E.; Fehlings, Michael; Arnold, Paul M.; Riew, K. Daniel

    2017-01-01

    Study Design: Multicenter retrospective study. Objectives: To investigate the risk of symptomatic recurrent laryngeal nerve palsy (RLNP) following cervical spine surgery, to examine risk factors for its development, and to report its treatment and outcomes. Methods: A multicenter study from 21 high-volume surgical centers from the AOSpine North America Clinical Research Network was performed. Each center screened for rare complications following cervical spine surgery, including RLNP. Patient...

  19. Mentoring in Clinical-Translational Research: A Study of Participants in Master's Degree Programs.

    Science.gov (United States)

    McGinn, Aileen P; Lee, Linda S; Baez, Adriana; Zwanziger, Jack; Anderson, Karl E; Seely, Ellen W; Schoenbaum, Ellie

    2015-12-01

    Research projects in translational science are increasingly complex and require interdisciplinary collaborations. In the context of training translational researchers, this suggests that multiple mentors may be needed in different content areas. This study explored mentoring structure as it relates to perceived mentoring effectiveness and other characteristics of master's-level trainees in clinical-translational research training programs. A cross-sectional online survey of recent graduates of clinical research master's program was conducted. Of 73 surveys distributed, 56.2% (n = 41) complete responses were analyzed. Trainees were overwhelmingly positive about participation in their master's programs and the impact it had on their professional development. Overall the majority (≥75%) of trainees perceived they had effective mentoring in terms of developing skills needed for conducting clinical-translational research. Fewer trainees perceived effective mentoring in career development and work-life balance. In all 15 areas of mentoring effectiveness assessed, higher rates of perceived mentor effectiveness was seen among trainees with ≥2 mentors compared to those with solo mentoring (SM). In addition, trainees with ≥2 mentors perceived having effective mentoring in more mentoring aspects (median: 14.0; IQR: 12.0-15.0) than trainees with SM (median: 10.5; IQR: 8.0-14.5). Results from this survey suggest having ≥2 mentors may be beneficial in fulfilling trainee expectations for mentoring in clinical-translational training. © 2015 Wiley Periodicals, Inc.

  20. Perspectives on Research Participation and Facilitation Among Dialysis Patients, Clinic Personnel, and Medical Providers: A Focus Group Study.

    Science.gov (United States)

    Flythe, Jennifer E; Narendra, Julia H; Dorough, Adeline; Oberlander, Jonathan; Ordish, Antoinette; Wilkie, Caroline; Dember, Laura M

    2017-12-19

    Most prospective studies involving individuals receiving maintenance dialysis have been small, and many have had poor clinical translatability. Research relevance can be enhanced through stakeholder engagement. However, little is known about dialysis clinic stakeholders' perceptions of research participation and facilitation. The objective of this study was to characterize the perspectives of dialysis clinic stakeholders (patients, clinic personnel, and medical providers) on: (1) research participation by patients and (2) research facilitation by clinic personnel and medical providers. We also sought to elucidate stakeholder preferences for research communication. Qualitative study. 7 focus groups (59 participants: 8 clinic managers, 14 nurses/patient care technicians, 8 social workers/dietitians, 11 nephrologists/advanced practice providers, and 18 patients/care partners) from 7 North Carolina dialysis clinics. Clinics and participants were purposively sampled. Focus groups were recorded and transcribed. Thematic analysis. We identified 11 themes that captured barriers to and facilitators of research participation by patients and research facilitation by clinic personnel and medical providers. We collapsed these themes into 4 categories to create an organizational framework for considering stakeholder (narrow research understanding, competing personal priorities, and low patient literacy and education levels), relationship (trust, buy-in, and altruistic motivations), research design (convenience, follow-up, and patient incentives), and dialysis clinic (professional demands, teamwork, and communication) aspects that may affect stakeholder interest in participating in or facilitating research. These themes appear to shape the degree of research readiness of a dialysis clinic environment. Participants preferred short research communications delivered in multiple formats. Potential selection bias and inclusion of English-speaking participants only. Our findings

  1. 77 FR 31072 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2012-05-24

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... Development Officer through the Director of the Clinical Science Research and Development Service on the... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  2. 76 FR 19189 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2011-04-06

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  3. 75 FR 79446 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2010-12-20

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... Officer through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  4. 76 FR 65781 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2011-10-24

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  5. 76 FR 73781 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2011-11-29

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... Officer through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  6. 75 FR 28686 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2010-05-21

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  7. Classification of Clinical Research Study Eligibility Criteria to Support Multi-Stage Cohort Identification Using Clinical Data Repositories.

    Science.gov (United States)

    Cimino, James J; Lancaster, William J; Wyatt, Mathew C

    2017-01-01

    One of the challenges to using electronic health record (EHR) repositories for research is the difficulty mapping study subject eligibility criteria to the query capabilities of the repository. We sought to characterize criteria as "easy" (searchable in a typical repository), "hard" (requiring manual review of the record data), and "impossible" (not typically available in EHR repositories). We obtained 292 criteria from 20 studies available from Clinical Trials.gov and rated them according to our three types, plus a fourth "mixed" type. We had good agreement among three independent reviewers and chose 274 criteria that were characterized by single types for further analysis. The resulting analysis showed typical features of criteria that do and don't map to repositories. We propose that these features be used to guide researchers in specifying eligibility criteria to improve development of enrollment workflow, including the definition of EHR repository queries for self-service or analyst-mediated retrievals.

  8. The clinical relevance and newsworthiness of NIHR HTA-funded research: a cohort study.

    Science.gov (United States)

    Wright, D; Young, A; Iserman, E; Maeso, R; Turner, S; Haynes, R B; Milne, R

    2014-05-07

    To assess the clinical relevance and newsworthiness of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme funded reports. Retrospective cohort study. The cohort included 311 NIHR HTA Programme funded reports publishing in HTA in the period 1 January 2007-31 December 2012. The McMaster Online Rating of Evidence (MORE) system independently identified the clinical relevance and newsworthiness of NIHR HTA publications and non-NIHR HTA publications. The MORE system involves over 4000 physicians rating publications on a scale of relevance (the extent to which articles are relevant to practice) and a scale of newsworthiness (the extent to which articles contain news or something clinicians are unlikely to know). The proportion of reports published in HTA meeting MORE inclusion criteria and mean average relevance and newsworthiness ratings were calculated and compared with publications from the same studies publishing outside HTA and non-NIHR HTA funded publications. 286/311 (92.0%) of NIHR HTA reports were assessed by MORE, of which 192 (67.1%) passed MORE criteria. The average clinical relevance rating for NIHR HTA reports was 5.48, statistically higher than the 5.32 rating for non-NIHR HTA publications (mean difference=0.16, 95% CI 0.04 to 0.29, p=0.01). Average newsworthiness ratings were similar between NIHR HTA reports and non-NIHR HTA publications (4.75 and 4.70, respectively; mean difference=0.05, 95% CI -0.18 to 0.07, p=0.402). NIHR HTA-funded original research reports were statistically higher for newsworthiness than reviews (5.05 compared with 4.64) (mean difference=0.41, 95% CI 0.18 to 0.64, p=0.001). Funding research of clinical relevance is important in maximising the value of research investment. The NIHR HTA Programme is successful in funding projects that generate outputs of clinical relevance.

  9. Linking clinical quality indicators to research evidence - a case study in asthma management for children.

    Science.gov (United States)

    Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B; Coiera, Enrico

    2017-07-21

    Clinical quality indicators are used to monitor the performance of healthcare services and should wherever possible be based on research evidence. Little is known however about the extent to which indicators in common use are based on research. The objective of this study is to measure the extent to which clinical quality indicators used in asthma management in children with outcome measurements can be linked to results in randomised controlled clinical trial (RCT) reports. This work is part of a broader research program to trial methods that improve the efficiency and accuracy of indicator development. National-level indicators for asthma management in children were extracted from the National Quality Measures Clearinghouse database and the National Institute for Health and Care Excellence quality standards by two independent appraisers. Outcome measures were extracted from all published English language RCT reports for asthma management in children below the age of 12 published between 2005 and 2014. The two sets were then linked by manually mapping both to a common set of Unified Medical Language System (UMLS) concepts. The analysis identified 39 indicators and 562 full text RCTs dealing with asthma management in children. About 95% (37/39) of the indicators could be linked to RCT outcome measures. It is possible to identify relevant RCT reports for the majority of indicators used to assess the quality of asthma management in childhood. The methods reported here could be automated to more generally support assessment of candidate indicators against the research evidence.

  10. [Ethical dilemma in research: informed consent in clinical studies on persons with dementia].

    Science.gov (United States)

    Sinoff, Gary

    2012-09-01

    With the world's population aging, there is an increase in the number of demented elderly. It is vital to study this phenomenon in epidemiological and clinical studies, particularly the effects on the increasing numbers of demented elderly. Researchers need to understand the factors predicting the general decline in the demented elderly. However, before any research is undertaken, it is necessary to obtain approval from the Local Internal Review Board. This committee is responsible to maintain accepted national and international ethical standards. The basis for recruitment to a study is the signature on the informed consent form, where the patient is required to understand the study, internalize the study's aim, to consider all options and finally, to express an opinion. Potential elderly participants need to have their judgment evaluated before signing the form. In cases where the subject is incapable, some countries, including Israel, require that there be a legal guardianship. This is a long and complicated process that causes researchers not to recruit demented patients into a study which may actually be beneficial to all. Some countries allow a proxy to sign informed consent forms to permit the demented subject to participate in the study. Often the threshold may depend on the invasiveness of the intervention. The problem of proxies to sign informed consent form troubles researchers worldwide. This article addresses the history and development of ethics in research, and raises the issue to promote an official policy for proxy consent signing.

  11. 77 FR 46764 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Science.gov (United States)

    2012-08-06

    ...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... per year. B. Research Objectives The goal of FDA's OPD grant program is to support the clinical... (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of...

  12. Specialist nurses' perceptions of inviting patients to participate in clinical research studies: a qualitative descriptive study of barriers and facilitators.

    Science.gov (United States)

    French, Caroline; Stavropoulou, Charitini

    2016-08-11

    Increasing the number of patients participating in research studies is a current priority in the National Health Service (NHS) in the United Kingdom. The role of specialist nurses in inviting patients to participate is important, yet little is known about their experiences of doing so. The aim of this study was to explore the perceptions of barriers and facilitators held by specialist nurses with experience of inviting adult NHS patients to a wide variety of research studies. A cross-sectional qualitative descriptive study was conducted between March and July 2015. Participants were 12 specialist nurses representing 7 different clinical specialties and 7 different NHS Trusts. We collected data using individual semi-structured interviews, and analysed transcripts using the Framework method to inductively gain a descriptive overview of barriers and facilitators. Barriers and facilitators were complex and interdependent. Perceptions varied among individuals, however barriers and facilitators centred on five main themes: i) assessing patient suitability, ii) teamwork, iii) valuing research, iv) the invitation process and v) understanding the study. Facilitators to inviting patients to participate in research often stemmed from specialist nurses' attitudes, skills and experience. Positive research cultures, effective teamwork and strong relationships between research and clinical teams at the local clinical team level were similarly important. Barriers were reported when specialist nurses felt they were providing patients with insufficient information during the invitation process, and when specialist nurses felt they did not understand studies to their satisfaction. Our study offers several new insights regarding the role of specialist nurses in recruiting patients for research. It shows that strong local research culture and teamwork overcome some wider organisational and workload barriers reported in previous studies. In addition, and in contrast to common practice

  13. Clinical Studies

    DEFF Research Database (Denmark)

    Pallesen, Ulla

    universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...... in vivo conditions. But real life is different and in vitro studies cannot include all variables. Only clinical studies can provide valid information on the clinical performance of restorations over time. What do we know about longevity of posterior resin restorations? What are the reasons for replacement...... and results from own up to 30-year prospective clinical university studies and practice based studies from Public Dental Health Service on the clinical performance of posterior composite resin restorations....

  14. Recruiting to cohort studies in specialist healthcare services: Lessons learned from clinical research nurses in UK cleft services.

    Science.gov (United States)

    Zucchelli, Fabio; Rumsey, Nichola; Humphries, Kerry; Bennett, Rhiannon; Davies, Amy; Sandy, Jonathan; Stock, Nicola Marie

    2018-03-01

    To explore the experiences of clinical research nurses recruiting patients in a large specialist care-based cohort study. Longitudinal studies are vital to better understand the aetiology and moderators of health conditions. This need is especially salient for congenital conditions, such as cleft lip and/or palate, where establishing large, comprehensive data sets from birth is vital to improve understanding and to inform interventions. Various barriers exist in recruiting patients to large cohort studies. The role of clinical research nurses embedded within health settings has grown over past decades to facilitate data collection, yet challenges remain. Qualitative descriptive study. Individual semi-structured interviews with 12 clinical research nurses based in 10 National Health Service cleft services across the UK, recruiting to the Cleft Collective Birth Cohort Study. Of seven emergent themes, three highlighted challenges to recruiting patients, another three described facilitative factors, and one theme overlapped challenges and facilitators. Challenges included the life circumstances of potential participants; language barriers; and limited clinical research nurse time for study. Facilitative factors included integrating research into clinical practice; patient information shared with clinical research nurses; and support from the university-based research study team. The theme "Method of data collection" related to both challenges and facilitators. The qualitative data from clinical research nurses recruiting to a large birth cohort study provide helpful practical detail for specialist healthcare teams, specialist nurses, clinical research nurses and researchers looking to optimise recruitment and data collection in longitudinal studies. The findings suggest the importance of specialist clinical services and research study teams cooperating to embed research into everyday clinical practice, without compromising care. This should facilitate patients

  15. Factors defining the mentoring competencies of clinical midwives: An exploratory quantitative research study in Japan.

    Science.gov (United States)

    Hishinuma, Yuri; Horiuchi, Shigeko; Yanai, Haruo

    2016-01-01

    Clinical education is an extremely important process in cultivating healthcare professionals, and the quality of educators has a major impact on the quality of future practitioners. Although practicing clinical midwives contribute to the education of pre-registered midwives and those qualified within the past year (new midwives), the factors defining the educational competencies of clinical midwives have not been clarified. The purpose of this study was to explore the factors that define the mentoring competencies of clinical midwives involved in educating new midwives. An exploratory quantitative research study. Questionnaires were distributed to 694 midwives who had previously conducted educational activities with new midwives at the 63 facilities whose administrator or nurse manager in charge of all staff, including midwives, consented to participate. Of the 694 midwives, 464 (66.9%) returned the questionnaire and 451 (65.1%) valid responses were analyzed. Exploratory factor analyses were performed on the following three concepts: [competency as a professional], [competency as an educator], and [personal characteristics]. [Competency as a professional] consisted of two factors: and ; [competency as an educator] consisted of four factors: , , and ; and [personal characteristics consisted of three factors: exercising leadership> , and . These three concepts were defined by a total of nine sub-concepts (factors), and 41 items were extracted with a reliability coefficient (Cronbach's α) of 0.944 CONCLUSIONS: "Mentoring competencies of clinical midwives (MCCM)" are defined by three concepts and nine sub-concepts, which can be evaluated by 41 items regarding the behavior, thoughts, and characteristics that clinical midwives exhibit when they educate new midwives in clinical settings. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. A qualitative study on acceptable levels of risk for pregnant women in clinical research

    NARCIS (Netherlands)

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

    2017-01-01

    There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical

  17. Clinical Impact Research – how to choose experimental or observational intervention study?

    Science.gov (United States)

    Malmivaara, Antti

    2016-01-01

    Abstract Background: Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. Aims: This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. Methods: The new concept is based on a narrative review of the literature and on author’s idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author’s previous work on the concepts benchmarking controlled trial and system impact research (SIR). Results: The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. Conclusions: CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messagesThe new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals.The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study

  18. Clinical Impact Research - how to choose experimental or observational intervention study?

    Science.gov (United States)

    Malmivaara, Antti

    2016-11-01

    Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental

  19. 75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Science.gov (United States)

    2010-08-06

    ...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of... product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and...

  20. A Clinical Reasoning Tool for Virtual Patients: Design-Based Research Study.

    Science.gov (United States)

    Hege, Inga; Kononowicz, Andrzej A; Adler, Martin

    2017-11-02

    Clinical reasoning is a fundamental process medical students have to learn during and after medical school. Virtual patients (VP) are a technology-enhanced learning method to teach clinical reasoning. However, VP systems do not exploit their full potential concerning the clinical reasoning process; for example, most systems focus on the outcome and less on the process of clinical reasoning. Keeping our concept grounded in a former qualitative study, we aimed to design and implement a tool to enhance VPs with activities and feedback, which specifically foster the acquisition of clinical reasoning skills. We designed the tool by translating elements of a conceptual clinical reasoning learning framework into software requirements. The resulting clinical reasoning tool enables learners to build their patient's illness script as a concept map when they are working on a VP scenario. The student's map is compared with the experts' reasoning at each stage of the VP, which is technically enabled by using Medical Subject Headings, which is a comprehensive controlled vocabulary published by the US National Library of Medicine. The tool is implemented using Web technologies, has an open architecture that enables its integration into various systems through an open application program interface, and is available under a Massachusetts Institute of Technology license. We conducted usability tests following a think-aloud protocol and a pilot field study with maps created by 64 medical students. The results show that learners interact with the tool but create less nodes and connections in the concept map than an expert. Further research and usability tests are required to analyze the reasons. The presented tool is a versatile, systematically developed software component that specifically supports the clinical reasoning skills acquisition. It can be plugged into VP systems or used as stand-alone software in other teaching scenarios. The modular design allows an extension with new

  1. Caught between a rock and a hard place: An intrinsic single case study of nurse researchers' experiences of the presence of a nursing research culture in clinical practice.

    Science.gov (United States)

    Berthelsen, Connie Bøttcher; Hølge-Hazelton, Bibi

    2018-04-01

    To explore how nurse researchers in clinical positions experience the presence of a nursing research culture in clinical practice. Higher demands in the hospitals for increasing the quality of patient care engender a higher demand for the skills of health professionals and evidence-based practice. However, the utilisation of nursing research in clinical practice is still limited. Intrinsic single case study design underlined by a constructivist perspective. Data were produced through a focus group interview with seven nurse researchers employed in clinical practice in two university hospitals in Zealand, Denmark, to capture the intrinsic aspects of the concept of nursing research culture in the context of clinical practice. A thematic analysis was conducted based on Braun and Clarke's theoretical guideline. "Caught between a rock and a hard place" was constructed as the main theme describing how nurse researchers in clinical positions experience the presence of a nursing research culture in clinical practice. The main theme was supported by three subthemes: Minimal academic tradition affects nursing research; Minimal recognition from physicians affects nursing research; and Moving towards a research culture. The nurse researchers in this study did not experience the presence of a nursing research culture in clinical practice, however; they called for more attention on removing barriers against research utilisation, promotion of applied research and interdisciplinary research collaboration, and passionate management support. The results of this case study show the pressure which nurse researchers employed in clinical practice are exposed to, and give examples on how to accommodate the further development of a nursing research culture in clinical practice. © 2017 John Wiley & Sons Ltd.

  2. Research ethics for clinical researchers.

    Science.gov (United States)

    Harnett, John D; Neuman, Richard

    2015-01-01

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

  3. Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study

    OpenAIRE

    Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

    2018-01-01

    Background Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of...

  4. Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations

    Science.gov (United States)

    Turk, Dennis C.; O’Connor, Alec B.; Dworkin, Robert H.; Chaudhry, Amina; Katz, Nathaniel P.; Adams, Edgar H.; Brownstein, John S.; Comer, Sandra D.; Dart, Richard; Dasgupta, Nabarun; Denisco, Richard A.; Klein, Michael; Leiderman, Deborah B.; Lubran, Robert; Rappaport, Bob A.; Zacny, James P.; Ahdieh, Harry; Burke, Laurie B.; Cowan, Penney; Jacobs, Petra; Malamut, Richard; Markman, John; Michna, Edward; Palmer, Pamela; Peirce-Sandner, Sarah; Potter, Jennifer S.; Raja, Srinivasa N.; Rauschkolb, Christine; Roland, Carl L.; Webster, Lynn R.; Weiss, Roger D.; Wolf, Kerry

    2013-01-01

    Opioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations. Due to the many types of individuals who may be exposed to opioids, an opioid formulation will need to be studied in several populations using various study designs in order to determine its abuse-deterrent capabilities. It is recommended that the research conducted to evaluate abuse deterrence should include studies assessing: (1) abuse liability; (2) the likelihood that opioid abusers will find methods to circumvent the deterrent properties of the formulation; (3) measures of misuse and abuse in randomized clinical trials involving pain patients with both low risk and high risk of abuse; and (4) post-marketing epidemiological studies. PMID:22770841

  5. Ethical issues in recruitment of "healthy volunteers": study of a clinical research organisation in Hyderabad.

    Science.gov (United States)

    Krishna, Shilpa; Prasad, N Purendra

    2014-01-01

    This paper raises some of the ethical issues involved in the recruitment of healthy volunteers (HVs) by clinical research organizations (CROs) for bioavailability and bioequivalent (BA/BE) studies. It also explores the underlying reasons for the participation of the HVs and their interaction with the CROs. The findings are based on the data collected from 50 HVs participating in a BA/BE study conducted by a CRO in Hyderabad and from the key officials involved in it. The findings indicate the existence of various complex networks, throw some light on the role of middlemen ("Anna") and the negotiation process, and give us an insight into the social norms and values that compelled the HVs to participate in the study. The paper offers a critical analysis of a few ethical concerns.

  6. Specialist nurses’ perceptions of inviting patients to participate in clinical research studies: a qualitative descriptive study of barriers and facilitators

    Directory of Open Access Journals (Sweden)

    Caroline French

    2016-08-01

    Full Text Available Abstract Background Increasing the number of patients participating in research studies is a current priority in the National Health Service (NHS in the United Kingdom. The role of specialist nurses in inviting patients to participate is important, yet little is known about their experiences of doing so. The aim of this study was to explore the perceptions of barriers and facilitators held by specialist nurses with experience of inviting adult NHS patients to a wide variety of research studies. Methods A cross-sectional qualitative descriptive study was conducted between March and July 2015. Participants were 12 specialist nurses representing 7 different clinical specialties and 7 different NHS Trusts. We collected data using individual semi-structured interviews, and analysed transcripts using the Framework method to inductively gain a descriptive overview of barriers and facilitators. Results Barriers and facilitators were complex and interdependent. Perceptions varied among individuals, however barriers and facilitators centred on five main themes: i assessing patient suitability, ii teamwork, iii valuing research, iv the invitation process and v understanding the study. Facilitators to inviting patients to participate in research often stemmed from specialist nurses’ attitudes, skills and experience. Positive research cultures, effective teamwork and strong relationships between research and clinical teams at the local clinical team level were similarly important. Barriers were reported when specialist nurses felt they were providing patients with insufficient information during the invitation process, and when specialist nurses felt they did not understand studies to their satisfaction. Conclusion Our study offers several new insights regarding the role of specialist nurses in recruiting patients for research. It shows that strong local research culture and teamwork overcome some wider organisational and workload barriers reported in

  7. Clinical evaluation of marketed orthodontic products: are researchers behind the times? A meta-epidemiological study

    Directory of Open Access Journals (Sweden)

    Jadbinder Seehra

    2017-05-01

    Full Text Available Abstract Background The role of marketing and industry in the treatment decisions of orthodontists has received increasing attention in recent years with clinical research typically undertaken subsequent to established use of these devices and often failing to confirm the promise of manufacturers’ claims. This meta-epidemiological study was undertaken to assess the proportion of clinical trials in orthodontics evaluating commercially marketed products and to evaluate the direction of the results of these studies. Methods Electronic searching was undertaken to identify randomized controlled trials (RCTs published over a 5-year period (1 January 2012 to 31 December 2016. Data obtained included the type of marketed intervention, direction of effect and declaration of both industry sponsorship and conflict of interest. Results Eighty-four RCTs published in 23 scientific journals were included with the highest percentage in the American Journal of Dentofacial Orthopedics (AJO-DO (23.8%, followed by the European Journal of Orthodontics (EJO (14.3%, Journal of Orthodontics (JO (10.7% and Angle Orthodontist (AO (10.7%. Overall, 45% (38/84 of clinical trials assessed involved analysis of marketed products after their introduction. Interventions to improve oral health or circumvent the risk of iatrogenic damage, such as white spot lesions, were most commonly assessed (15.8%, with the relative merits of non-surgical adjuncts (14.1% and other orthodontic auxiliaries (13.1% also frequently evaluated. In 44% of RCTs, a positive effect of the marketed intervention was not reported. Industry sponsorship of the research was declared in 9.5% RCTs. No significant associations between the direction of the effect and both declaration of industry sponsorship (p = 0.56 and conflict of interest (p = 0.96 were detected. Moreover, for marketed and non-marketed products, no significant associations for both declaration of industry sponsorship (p = 0.44 and

  8. Clinical Epidemiology Unit - overview of research areas

    Science.gov (United States)

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

  9. Comparison of methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles.

    Science.gov (United States)

    Schneider, Barbara St Pierre; Nicholas, Jennifer; Kurrus, Jeffrey E

    2013-01-01

    To compare the methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles. The methodologic quality of quantitative nursing education research needs to advance to a higher level. Clinical research can provide guidance for nursing education to reach this level. One hundred quantitative clinical research articles from-high impact journals published in 2007 and 37 education research articles from high impact journals published in 2006 to 2007 were chosen for analysis. Clinical articles had significantly higher quality scores than education articles in three domains: number of institutions studied, type of data, and outcomes. The findings indicate three ways in which nursing education researchers can strengthen the methodologic quality of their quantitative research. With this approach, greater funding may be secured for advancing the science of nursing education.

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

    Directory of Open Access Journals (Sweden)

    Cheng eWang

    2012-10-01

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

  11. Strategies to design clinical studies to identify predictive biomarkers in cancer research.

    Science.gov (United States)

    Perez-Gracia, Jose Luis; Sanmamed, Miguel F; Bosch, Ana; Patiño-Garcia, Ana; Schalper, Kurt A; Segura, Victor; Bellmunt, Joaquim; Tabernero, Josep; Sweeney, Christopher J; Choueiri, Toni K; Martín, Miguel; Fusco, Juan Pablo; Rodriguez-Ruiz, Maria Esperanza; Calvo, Alfonso; Prior, Celia; Paz-Ares, Luis; Pio, Ruben; Gonzalez-Billalabeitia, Enrique; Gonzalez Hernandez, Alvaro; Páez, David; Piulats, Jose María; Gurpide, Alfonso; Andueza, Mapi; de Velasco, Guillermo; Pazo, Roberto; Grande, Enrique; Nicolas, Pilar; Abad-Santos, Francisco; Garcia-Donas, Jesus; Castellano, Daniel; Pajares, María J; Suarez, Cristina; Colomer, Ramon; Montuenga, Luis M; Melero, Ignacio

    2017-02-01

    The discovery of reliable biomarkers to predict efficacy and toxicity of anticancer drugs remains one of the key challenges in cancer research. Despite its relevance, no efficient study designs to identify promising candidate biomarkers have been established. This has led to the proliferation of a myriad of exploratory studies using dissimilar strategies, most of which fail to identify any promising targets and are seldom validated. The lack of a proper methodology also determines that many anti-cancer drugs are developed below their potential, due to failure to identify predictive biomarkers. While some drugs will be systematically administered to many patients who will not benefit from them, leading to unnecessary toxicities and costs, others will never reach registration due to our inability to identify the specific patient population in which they are active. Despite these drawbacks, a limited number of outstanding predictive biomarkers have been successfully identified and validated, and have changed the standard practice of oncology. In this manuscript, a multidisciplinary panel reviews how those key biomarkers were identified and, based on those experiences, proposes a methodological framework-the DESIGN guidelines-to standardize the clinical design of biomarker identification studies and to develop future research in this pivotal field. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. A learning activity to introduce undergraduate students to bioethics in human clinical research: a case study.

    Science.gov (United States)

    Segarra, Ignacio; Gomez, Manuel

    2014-12-01

    We developed a pharmacology practicum assignment to introduce students to the research ethics and steps involved in a clinical trial. The assignment included literature review, critical analysis of bioethical situations, writing a study protocol and presenting it before a simulated ethics committee, a practice interview with a faculty member to obtain informed consent, and a student reflective assessment and self-evaluation. Students were assessed at various steps in the practicum; the learning efficiency of the activity was evaluated using an independent survey as well as students' reflective feedback. Most of the domains of Bloom's and Fink's taxonomies of learning were itemized and covered in the practicum. Students highly valued the translatability of theoretical concepts into practice as well as the approach to mimic professional practice. This activity was within a pharmacy program, but may be easily transferable to other medical or health sciences courses. © The Author(s) 2014.

  13. Teaching medical students to discern ethical problems in human clinical research studies.

    Science.gov (United States)

    Roberts, Laura Weiss; Warner, Teddy D; Green Hammond, Katherine A; Brody, Janet L; Kaminsky, Alexis; Roberts, Brian B

    2005-10-01

    Investigators and institutional review boards are entrusted with ensuring the conduct of ethically sound human studies. Assessing ethical aspects of research protocols is a key skill in fulfilling this duty, yet no empirically validated method exists for preparing professionals to attain this skill. The authors performed a randomized controlled educational intervention, comparing a criteria-based learning method, a clinical-research- and experience-based learning method, and a control group. All 300 medical students enrolled at the University of New Mexico School of Medicine in 2001 were invited to participate. After a single half-hour educational session, a written posttest of ability to detect ethical problems in hypothetical protocol vignettes was administered. The authors analyzed responses to ten protocol vignettes that had been evaluated independently by experts. For each vignette, a global assessment of the perceived significance of ethical problems and the identification of specific ethical problems were evaluated. Eighty-three medical students (27%) volunteered: 50 (60%) were women and 55 (66%) were first- and second-year students. On global assessments, the criteria-focused group perceived ethical problems as more significant than did the other two groups (p evaluation skills. This work supports the potential value of empirically derived methods for preparing professionals to discern ethical aspects of human studies.

  14. Five Steps to Successfully Implement and Evaluate Propensity Score Matching in Clinical Research Studies.

    Science.gov (United States)

    Staffa, Steven J; Zurakowski, David

    2018-01-09

    In clinical research, the gold standard level of evidence is the randomized controlled trial (RCT). The availability of nonrandomized retrospective data is growing; however, a primary concern of analyzing such data is comparability of the treatment groups with respect to confounding variables. Propensity score matching (PSM) aims to equate treatment groups with respect to measured baseline covariates to achieve a comparison with reduced selection bias. It is a valuable statistical methodology that mimics the RCT, and it may create an "apples to apples" comparison while reducing bias due to confounding. PSM can improve the quality of anesthesia research and broaden the range of research opportunities. PSM is not necessarily a magic bullet for poor-quality data, but rather may allow the researcher to achieve balanced treatment groups similar to a RCT when high-quality observational data are available. PSM may be more appealing than the common approach of including confounders in a regression model because it allows for a more intuitive analysis of a treatment effect between 2 comparable groups.We present 5 steps that anesthesiologists can use to successfully implement PSM in their research with an example from the 2015 Pediatric National Surgical Quality Improvement Program: a validated, annually updated surgery and anesthesia pediatric database. The first step of PSM is to identify its feasibility with regard to the data at hand and ensure availability of data on any potential confounders. The second step is to obtain the set of propensity scores from a logistic regression model with treatment group as the outcome and the balancing factors as predictors. The third step is to match patients in the 2 treatment groups with similar propensity scores, balancing all factors. The fourth step is to assess the success of the matching with balance diagnostics, graphically or analytically. The fifth step is to apply appropriate statistical methodology using the propensity

  15. Researchers', Regulators', and Sponsors' Views on Pediatric Clinical Trials: A Multinational Study.

    Science.gov (United States)

    Joseph, Pathma D; Craig, Jonathan C; Tong, Allison; Caldwell, Patrina H Y

    2016-10-01

    The last decade has seen dramatic changes in the regulatory landscape to support more trials involving children, but child-specific challenges and inequitable conduct across income regions persist. The goal of this study was to describe the attitudes and opinions of stakeholders toward trials in children, to inform additional strategies to promote more high-quality, relevant pediatric trials across the globe. Key informant semi-structured interviews were conducted with stakeholders (researchers, regulators, and sponsors) who were purposively sampled from low- to middle-income countries and high-income countries. The transcripts were thematically analyzed. Thirty-five stakeholders from 10 countries were interviewed. Five major themes were identified: addressing pervasive inequities (paucity of safety and efficacy data, knowledge disparities, volatile environment, double standards, contextual relevance, market-driven forces, industry sponsorship bias and prohibitive costs); contending with infrastructural barriers (resource constraints, dearth of pediatric trial expertise, and logistical complexities); navigating complex ethical and regulatory frameworks ("draconian" oversight, ambiguous requirements, exploitation, excessive paternalism and precariousness of coercion versus volunteerism); respecting uniqueness of children (pediatric research paradigms, child-appropriate approaches, and family-centered empowerment); and driving evidence-based child health (advocacy, opportunities, treatment access, best practices, and research prioritization). Stakeholders acknowledge that changes in the regulatory environment have encouraged more trials in children, but they contend that inequities and political, regulatory, and resource barriers continue to exist. Embedding trials as part of routine clinical care, addressing the unique needs of children, and streamlining regulatory approvals were suggested. Stakeholders recommended increasing international collaboration

  16. [Research activity in clinical biochemistry

    DEFF Research Database (Denmark)

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

    2008-01-01

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

  17. [Research activity in clinical biochemistry

    DEFF Research Database (Denmark)

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

    2008-01-01

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

  18. Visual research in clinical education.

    Science.gov (United States)

    Bezemer, Jeff

    2017-01-01

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

  19. Nursing students' satisfaction of the clinical learning environment: a research study.

    Science.gov (United States)

    Papastavrou, Evridiki; Dimitriadou, Maria; Tsangari, Haritini; Andreou, Christos

    2016-01-01

    The acquisition of quality clinical experience within a supportive and pedagogically adjusted clinical learning environment is a significant concern for educational institutions. The quality of clinical learning usually reflects the quality of the curriculum structure. The assessment of the clinical settings as learning environment is a significant concern within the contemporary nursing education. The nursing students' satisfaction is considered as an important factor of such assessment, contributing to any potential reforms in order to optimize the learning activities and achievements within clinical settings. The aim of the study was to investigate nursing students' satisfaction of the clinical settings as learning environments. A quantitative descriptive, correlational design was used. A sample of 463 undergraduate nursing students from the three universities in Cyprus were participated. Data were collected using the Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T). Nursing students were highly satisfied with the clinical learning environment and their satisfaction has been positively related to all clinical learning environment constructs namely the pedagogical atmosphere, the Ward Manager's leadership style, the premises of Nursing in the ward, the supervisory relationship (mentor) and the role of the Nurse Teacher (p relationship. The frequency of meetings among the students and the mentors increased the students' satisfaction with the clinical learning environment. It was also revealed that 1st year students were found to be more satisfied than the students in other years. The supervisory relationship was evaluated by the students as the most influential factor in their satisfaction with the clinical learning environment. Student's acceptance within the nursing team and a well-documented individual nursing care is also related with students' satisfaction. The pedagogical atmosphere is considered pivotal, with reference to

  20. Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

    Science.gov (United States)

    Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

    2018-02-15

    There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

  1. MR spectroscopy in clinical research

    DEFF Research Database (Denmark)

    Henriksen, O

    1994-01-01

    MR spectroscopy (MRS) offers unique possibilities for non-invasive evaluation of biochemistry in vivo. During recent years there has been a growing body of evidence from clinical research studies on human beings using 31P and 1H MRS. The results indicate that it is possible to evaluate phosphorous...

  2. School-Based Health Clinics: An Analysis of the Johns Hopkins Study. Research Developments.

    Science.gov (United States)

    Demsko, Tobin W.

    School-based health clinics, adolescent pregnancy prevention programs offering comprehensive health services, represent the latest initiative to reduce the incidence of teenage pregnancy. Researchers at Johns Hopkins University designed and administered a pregnancy prevention program which offered sexuality education and family planning services…

  3. The clinical research office of the endourological society percutaneous nephrolithotomy global study

    DEFF Research Database (Denmark)

    Fuller, Andrew; Razvi, Hassan; Denstedt, John D

    2014-01-01

    in morbidly obese patients was assessed using a prospective database administered by the Clinical Research Office of the Endourological Society (CROES). A multidimensional match of 97 morbidly obese patients with those of normal weight was created using propensity score matching. Student's t-test and Chi...

  4. Examining Pediatric Cases From the Clinical Research Office of the Endourological Society Ureteroscopy Global Study.

    Science.gov (United States)

    Guven, Selcuk; Basiri, Abbas; Varshney, Anil Kumar; Aridogan, Ibrahim Atilla; Miura, Hiroyasu; White, Mark; Kilinc, Mehmet; de la Rosette, Jean

    2017-03-01

    To evaluate the characteristics and outcomes of ureteroscopy (URS) in children treated in several hospitals participating in the Clinical Research Office of the Endourological Society (CROES) Study, and to present the overall results of pediatric URS compared with adults. The CROES Study collected data on consecutive patients treated with URS for urolithiasis at each participating center over a 1-year period. The collected prospective global database includes data for 11,885 patients who received URS at 114 centers in 32 countries. Of these URS-treated patients, 192 were ≤18 years old. Of the 114 centers participating in the study, 42% had conducted pediatric URS. Among the pediatric cases, 7 were infants, 53 were small children, 59 were school-aged children, and 73 were adolescents. A considerable number (37%) of the pediatric cases had previously undergone URS treatment. No differences in the surgical outcomes of the adults and children were reported. The URS-treated children had a greater number of positive preoperative urine cultures when compared with adult cases treated. A semirigid scope was used in the vast majority of pediatric cases (85%). According to the present data, within the group of URS-treated children, the younger the child, the more readmissions occurred. URS is as efficient and safe in children as it is in adults. The data suggest that readmissions among URS-treated children are associated with age, with the likelihood of readmissions greater among younger age groups. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. The Power of Flash Mob Research Conducting a Nationwide Observational Clinical Study on Capillary Refill Time in a Single Day

    NARCIS (Netherlands)

    Alsma, Jelmer; van Saase, Jan L. C. M.; Nanayakkara, Prabath W. B.; Schouten, W. E. M. Ineke; Baten, Anique; Bauer, Martijn P.; Holleman, Frits; Ligtenberg, Jack J. M.; Stassen, Patricia M.; Kaasjager, Karin H. A. H.; Haak, Harm R.; Bosch, Frank H.; Schuit, Stephanie C. E.

    BACKGROUND: Capillary refill time (CRT) is a clinical test used to evaluate the circulatory status of patients; various methods are available to assess CRT. Conventional clinical research often demands large numbers of patients, making it costly, labor-intensive, and time-consuming. We studied the

  6. A Clinical Research Study of Cognitive Dysfunction and Affective Impairment after Isolated Brainstem Stroke

    Directory of Open Access Journals (Sweden)

    Xiujuan Fu

    2017-12-01

    Full Text Available Although the function of the cerebellum in neurocognition has been well-documented, the similar role of the brainstem has yet to be fully elucidated. This clinical research study aimed to combine data relating to neuropsychological assessments and P300 to explore cognitive dysfunction and affective impairment following brainstem stroke. Thirty-four patients with isolated brainstem stroke and twenty-six healthy controls were recruited; for each patient, we collated data pertaining to the P300, Addenbrooke's Cognitive Examination III (ACE-III, Montreal Cognitive Assessment Chinese version (MoCA, trail-making test (TMT, Symbol Digit Modalities Test (SDMT, Wechsler Adult Intelligence Scale-Digit Spans (DS, Stroop test, Self Rating Depression Scale (SDS, and Self Rating Anxiety Scale (SAS. Significance was analyzed using an independent T-test or the Mann-Whitney U-test. Correlation was analyzed using Pearson's correlation analysis or Spearman's correlation analysis. Collectively, data revealed that brainstem stroke caused mild cognitive impairment (MCI, and that visuospatial, attention, linguistic, and emotional disturbances may occur after isolated brainstem stroke. Cognitive decline was linked to P300 latency, ACE-III, and MoCA; P300 latency was correlated with ACE-III. Patients with right brainstem lesions were more likely to suffer memory decline. The present study provides initial data relating to the role of the brainstem in neurocognition, and will be useful for further understanding of vascular cognitive and affective impairment.

  7. A Clinical Research Study of Cognitive Dysfunction and Affective Impairment after Isolated Brainstem Stroke

    Science.gov (United States)

    Fu, Xiujuan; Lu, Zuneng; Wang, Yan; Huang, Lifang; Wang, Xi; Zhang, Hong; Xiao, Zheman

    2017-01-01

    Although the function of the cerebellum in neurocognition has been well-documented, the similar role of the brainstem has yet to be fully elucidated. This clinical research study aimed to combine data relating to neuropsychological assessments and P300 to explore cognitive dysfunction and affective impairment following brainstem stroke. Thirty-four patients with isolated brainstem stroke and twenty-six healthy controls were recruited; for each patient, we collated data pertaining to the P300, Addenbrooke's Cognitive Examination III (ACE-III), Montreal Cognitive Assessment Chinese version (MoCA), trail-making test (TMT), Symbol Digit Modalities Test (SDMT), Wechsler Adult Intelligence Scale-Digit Spans (DS), Stroop test, Self Rating Depression Scale (SDS), and Self Rating Anxiety Scale (SAS). Significance was analyzed using an independent T-test or the Mann-Whitney U-test. Correlation was analyzed using Pearson's correlation analysis or Spearman's correlation analysis. Collectively, data revealed that brainstem stroke caused mild cognitive impairment (MCI), and that visuospatial, attention, linguistic, and emotional disturbances may occur after isolated brainstem stroke. Cognitive decline was linked to P300 latency, ACE-III, and MoCA; P300 latency was correlated with ACE-III. Patients with right brainstem lesions were more likely to suffer memory decline. The present study provides initial data relating to the role of the brainstem in neurocognition, and will be useful for further understanding of vascular cognitive and affective impairment. PMID:29311895

  8. Bias in clinical intervention research

    DEFF Research Database (Denmark)

    Gluud, Lise Lotte

    2006-01-01

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

  9. Recurrent Laryngeal Nerve Palsy After Cervical Spine Surgery: A Multicenter AOSpine Clinical Research Network Study.

    Science.gov (United States)

    Gokaslan, Ziya L; Bydon, Mohamad; De la Garza-Ramos, Rafael; Smith, Zachary A; Hsu, Wellington K; Qureshi, Sheeraz A; Cho, Samuel K; Baird, Evan O; Mroz, Thomas E; Fehlings, Michael; Arnold, Paul M; Riew, K Daniel

    2017-04-01

    Multicenter retrospective study. To investigate the risk of symptomatic recurrent laryngeal nerve palsy (RLNP) following cervical spine surgery, to examine risk factors for its development, and to report its treatment and outcomes. A multicenter study from 21 high-volume surgical centers from the AOSpine North America Clinical Research Network was performed. Each center screened for rare complications following cervical spine surgery, including RLNP. Patients were included if they underwent cervical spine surgery (levels from C2 to C7) between January 1, 2005 and December 31, 2011. Data were analyzed with regard to complication treatment and outcome. Cases were compared to a control group from the AOSpine CSM and CSM-I studies. Three centers reported 19 cases of RLNP from a cohort of 1345 patients. The reported incidence of RLNP ranged from 0.6% to 2.9% between these 3 centers. Fifteen patients (79%) in the RLNP group were approached from the left side. Ten patients (52.6%) required treatment for RLNP-6 required medical therapy (steroids), 1 interventional treatment (injection laryngoplasty), and 3 conservative therapy (speech therapy). When examining outcomes, 73.7% (14/19) of cases resolved completely, 15.8% (3/19) resolved with residual effects, and in 10.5% (2/19) of cases this could not be determined. In this multicenter study examining rare complications following cervical spine surgery, the risk of RLNP after cervical spine surgery ranged from 0.6% to 2.9% between centers. Though rare, it was found that 16% of patients may experience partial resolution with residual effects, and 74% resolve completely.

  10. Balancing collaborative and independent practice roles in clinical pharmacy: a qualitative research study.

    Science.gov (United States)

    McCullough, Megan B; Solomon, Jeffrey L; Petrakis, Beth Ann; Park, Angela M; Ourth, Heather; Morreale, Anthony P; Rose, Adam J

    2015-02-01

    Clinical pharmacists (CPs) with a scope of practice operate as direct care providers and health care team members. Research often focuses on one role or the other; little is understood about the dynamic relationship between roles in practice settings. To identify the challenges CPs face in balancing dual roles as direct care providers and health care team members and the implications for CP effectiveness and quality of care. Pharmacists were interviewed with a primary purpose of informing an implementation effort. Besides the implementation, there were emergent themes regarding the challenges posed for CPs in negotiating dual roles. This study is, therefore, a secondary analysis of semistructured interviews and direct observation of 48 CPs, addressing this phenomenon. Interview data were entered into NVivo 10 and systematically analyzed using an emergent thematic coding strategy. Pharmacists describe role ambiguity, where they perform as direct providers or team members simultaneously or in quick succession. They note the existence of a "transaction cost," where switching causes loss of momentum or disruption of work flow. Additionally, pharmacists feel that fellow providers lack an understanding of what they do and that CP contributions are not evaluated accurately by other health professionals. It is a challenge for CPs to balance the distinct roles of serving as collaborators and primary providers. Frequent role switching is not conducive to optimal work efficiency or patient care. Our findings suggest concrete steps that medical centers can take to improve both CP worklife and quality of patient care. © The Author(s) 2014.

  11. What is the impact of research champions on integrating research in mental health clinical practice? A quasiexperimental study in South London, UK.

    Science.gov (United States)

    Oduola, Sherifat; Wykes, Til; Robotham, Dan; Craig, Tom K J

    2017-09-11

    Key challenges for mental health healthcare professionals to implement research alongside clinical activity have been highlighted, such as insufficient time to apply research skills and lack of support and resources. We examined the impact of employing dedicated staff to promote research in community mental health clinical settings. Quasiexperiment before and after study. South London and Maudsley National Health Service Foundation Trust. 4455 patients receiving care from 15 community mental health teams between 1 December 2013 and 31 December 2014. The proportion of patients approached for research participation in clinical services where research champions were present (intervention group), and where research champions were not present (comparison group). Patients in the intervention group were nearly six times more likely to be approached for research participation (Adj. OR=5.98; 95% CI 4.96 to 7.22). Investing in staff that promote and drive research in clinical services increases opportunities for patients to hear about and engage in clinical research studies. However, investment needs to move beyond employing short-term staff. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Physicians' perception of alternative displays of clinical research evidence for clinical decision support - A study with case vignettes.

    Science.gov (United States)

    Slager, Stacey L; Weir, Charlene R; Kim, Heejun; Mostafa, Javed; Del Fiol, Guilherme

    2017-07-01

    To design alternate information displays that present summaries of clinical trial results to clinicians to support decision-making; and to compare the displays according to efficacy and acceptability. A 6-between (information display presentation order) by 3-within (display type) factorial design. Two alternate displays were designed based on Information Foraging theory: a narrative summary that reduces the content to a few sentences; and a table format that structures the display according to the PICO (Population, Intervention, Comparison, Outcome) framework. The designs were compared with the summary display format available in PubMed. Physicians were asked to review five clinical studies retrieved for a case vignette; and were presented with the three display formats. Participants were asked to rate their experience with each of the information displays according to a Likert scale questionnaire. Twenty physicians completed the study. Overall, participants rated the table display more highly than either the text summary or PubMed's summary format (5.9vs. 5.4vs. 3.9 on a scale between 1 [strongly disagree] and 7 [strongly agree]). Usefulness ratings of seven pieces of information, i.e. patient population, patient age range, sample size, study arm, primary outcome, results of primary outcome, and conclusion, were high (average across all items=4.71 on a 1 to 5 scale, with 1=not at all useful and 5=very useful). Study arm, primary outcome, and conclusion scored the highest (4.9, 4.85, and 4.85 respectively). Participants suggested additional details such as rate of adverse effects. The table format reduced physicians' perceived cognitive effort when quickly reviewing clinical trial information and was more favorably received by physicians than the narrative summary or PubMed's summary format display. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. [Basic symptoms in schizophrenia, their clinical study and relevance in research].

    Science.gov (United States)

    Miret, Salvador; Fatjó-Vilas, Mar; Peralta, Víctor; Fañanás, Lourdes

    2016-01-01

    Basic symptoms consist of subtle sub-clinical disturbances subjectively experienced by schizophrenia patients. These are mainly related to drive, affect, thinking and language, perception, memory, motor action, central vegetative functions, control of cognitive processes, and stress tolerance. Initially described by Huber, from a phenomenological approach, basic symptoms are part of the earliest features of schizophrenia, and they can evolve along the course of the disorder. Their assessment during the prodromal phase of the disease (together with ultra-high risk criteria) is one of the 2 main approaches that allow the definition of states of clinical risk for the development of psychosis. The present review provides an updated view of the concept of basic symptoms, highlighting its potential value in establishing neurobiological correlates of interest in aetiopathogenic research. Copyright © 2015 SEP y SEPB. Published by Elsevier España. All rights reserved.

  14. Dynamic Studies with Radioisotopes in Medicine. Proceedings of the Symposium on Dynamics Studies with Radioisotopes in Clinical Medicine and Research

    International Nuclear Information System (INIS)

    1971-01-01

    Observations on the temporal patterns of uptake, metabolism, clearance or excretion of administered radioactive materials form the basis of many important applications of radioisotopes in clinical medicine and research. Such applications include studies of organ function, of regional blood flow and of the turnover of various substances in the human body. Newly available radioisotopes, new instruments such as gamma came ras, new techniques and new methods of data analysis based on the use of analogue and digital computers are continually enlarging the scope of the applications. Progress in these matters was discussed at the Symposium on Dynamic Studies with Radioisotopes in Clinical Medicine and Research, organized by the lnternational Atomic Energy Agency and held in Rotterdam, The Netherlands, from 31 August to 4 September 1970. A total of 315 participants nominated by 39 countries and 4 international organizations attended, and the 70 papers presented cove r the theoretical aspects of dynamic studies, the development of techniques and instruments for such studies, and specific applications in studies of thyroid, renal, hepatic and splenic function, mineral metabolism, regional blood flow, and cardiac and pulmonary function. The proceedings include the full texts of all the papers presented together with the edited discussions. Invited review papers deal with the general aspects of the various main groups of applications covered. Many of the applications described have already reached the stage of routine use; others are still in the developmental stage. Of particular note in the latter connection are applications based on the quantitative analysis of scintillation camera data. The many papers presented on these topics and the ensuing discussions indicate the great interest now shown in this promising area of development. It is hoped that the proceedings will provide a valuable guide to the present status of the subject

  15. [Research activity in clinical biochemistry].

    Science.gov (United States)

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

    2008-09-01

    Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched control group from other medical specialities in Denmark. A list of all physicians registered in Denmark (23,127 persons) was drawn from the database "Laeger.dk". Of these, 5,202 were generalists (not included) while 11,691 were from other specialities. Of the 126 specialists from Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained. 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry compared to 51 for the control group. The number of citations per specialist was 1,844 for Clinical Biochemistry compared to 816 for the control group. The top ten H-indices (of which 8 were in Clinical Biochemistry) ranged from 30 to 69. Both the number of papers and the number of citations were higher for Clinical Biochemistry than for the control group. The difference was most pronounced among professors.

  16. Shunting outcomes in posthemorrhagic hydrocephalus: results of a Hydrocephalus Clinical Research Network prospective cohort study.

    Science.gov (United States)

    Wellons, John C; Shannon, Chevis N; Holubkov, Richard; Riva-Cambrin, Jay; Kulkarni, Abhaya V; Limbrick, David D; Whitehead, William; Browd, Samuel; Rozzelle, Curtis; Simon, Tamara D; Tamber, Mandeep S; Oakes, W Jerry; Drake, James; Luerssen, Thomas G; Kestle, John

    2017-07-01

    OBJECTIVE Previous Hydrocephalus Clinical Research Network (HCRN) retrospective studies have shown a 15% difference in rates of conversion to permanent shunts with the use of ventriculosubgaleal shunts (VSGSs) versus ventricular reservoirs (VRs) as temporization procedures in the treatment of hydrocephalus due to high-grade intraventricular hemorrhage (IVH) of prematurity. Further research in the same study line revealed a strong influence of center-specific decision-making on shunt outcomes. The primary goal of this prospective study was to standardize decision-making across centers to determine true procedural superiority, if any, of VSGS versus VR as a temporization procedure in high-grade IVH of prematurity. METHODS The HCRN conducted a prospective cohort study across 6 centers with an approximate 1.5- to 3-year accrual period (depending on center) followed by 6 months of follow-up. Infants with premature birth, who weighed less than 1500 g, had Grade 3 or 4 IVH of prematurity, and had more than 72 hours of life expectancy were included in the study. Based on a priori consensus, decisions were standardized regarding the timing of initial surgical treatment, upfront shunt versus temporization procedure (VR or VSGS), and when to convert a VR or VSGS to a permanent shunt. Physical examination assessment and surgical technique were also standardized. The primary outcome was the proportion of infants who underwent conversion to a permanent shunt. The major secondary outcomes of interest included infection and other complication rates. RESULTS One hundred forty-five premature infants were enrolled and met criteria for analysis. Using the standardized decision rubrics, 28 infants never reached the threshold for treatment, 11 initially received permanent shunts, 4 were initially treated with endoscopic third ventriculostomy (ETV), and 102 underwent a temporization procedure (36 with VSGSs and 66 with VRs). The 2 temporization cohorts were similar in terms of sex, race

  17. SPECIAL ARTICLE Clinical research

    African Journals Online (AJOL)

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

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

    OpenAIRE

    C. A. Caramori

    2007-01-01

    Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong c...

  19. Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

    Directory of Open Access Journals (Sweden)

    Vale Claire L

    2012-01-01

    Full Text Available Abstract Background We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs, meta-analyses and other studies carried out by the UK Medical Research Council (MRC Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV. Methods Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009 were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research. Results Between October 2009 and April 2010, 138 completed questionnaires (86% were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31% had some consumer involvement, most commonly as members of trial management groups (TMG [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers. Conclusions Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development

  20. Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: results of a survey.

    Science.gov (United States)

    Vale, Claire L; Thompson, Lindsay C; Murphy, Claire; Forcat, Silvia; Hanley, Bec

    2012-01-13

    We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs), meta-analyses and other studies carried out by the UK Medical Research Council (MRC) Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV. Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009) were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research. Between October 2009 and April 2010, 138 completed questionnaires (86%) were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31%) had some consumer involvement, most commonly as members of trial management groups (TMG) [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers. Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development of a unit policy on consumer involvement, to guide future

  1. 75 FR 53701 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01...

    Science.gov (United States)

    2010-09-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0394] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01); Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug...

  2. Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees - results from a descriptive questionnaire-based study.

    Science.gov (United States)

    Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

    2018-01-11

    Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon?' This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score ± standard deviation. Ten RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6 ± 22.3/175 points reflecting thus an excellent adherence to international standards. Inadequate training of REC members and the lack of anti-bribery policies should be resolved to

  3. Bridging clinical researcher perceptions and health IT realities: A case study of stakeholder creep.

    Science.gov (United States)

    Panyard, Daniel J; Ramly, Edmond; Dean, Shannon M; Bartels, Christie M

    2018-02-01

    We present a case report detailing a challenge in health information technology (HIT) project implementations we term "stakeholder creep": not thoroughly identifying which stakeholders need to be involved and why before starting a project, consequently not understanding the true effort, skill sets, social capital, and time required to complete the project. A root cause analysis was performed post-implementation to understand what led to stakeholder creep. HIT project stakeholders were given a questionnaire to comment on these misconceptions and a proposed implementation tool to help mitigate stakeholder creep. Stakeholder creep contributed to an unexpected increase in time (3-month delayed go-live) and effort (68% over expected HIT work hours). Four main clinician/researcher misconceptions were identified that contributed to the development of stakeholder creep: 1) that EHR IT is a single group; 2) that all EHR IT members know the entire EHR functionality; 3) that changes to an EHR need the input of just a single EHR IT member; and 4) that the technological complexity of a project mirrors the clinical complexity. HIT project stakeholders similarly perceived clinicians/researchers to hold these misconceptions. The proposed stakeholder planning tool was perceived to be feasible and helpful. Stakeholder creep can negatively affect HIT project implementations. Projects may be susceptible to stakeholder creep when clinicians/researchers hold misconceptions related to HIT organization and processes. Implementation tools, such as the proposed stakeholder checklist, could be helpful in preempting and mitigating the effect of stakeholder creep. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Professional impact of clinical research

    Energy Technology Data Exchange (ETDEWEB)

    Nelhans, G.

    2016-07-01

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

  5. Does integrating research into the prosthetics and orthotics undergraduate curriculum enhance students' clinical practice? An interview study on students' perception.

    Science.gov (United States)

    Al Qaroot, Bashar S; Sobuh, Mohammad

    2016-06-01

    Problem-based learning (where rather than feeding students the knowledge, they look for it themselves) has long been thought of as an ideal approach in teaching because it would encourage students to acquire knowledge from an undetermined medium of wrong and right answers. However, the effect of such approach in the learning experience of prosthetics and orthotics students has never been investigated. This study explores the implications of integrating problem-based learning into teaching on the students' learning experience via implementing a research-informed clinical practice module into the curriculum of last year prosthetics and orthotics undergraduate students at the University of Jordan (Amman, Jordan). Qualitative research pilot study. Grounded theory approach was used based on the data collected from interviewing a focus group of four students. Students have identified a number of arguments from their experience in the research-informed clinical practice where, generally speaking, students described research-informed clinical practice as a very good method of education. Integrating problem-based learning into teaching has many positive implications. In particular, students pointed out that their learning experience and clinical practice have much improved after the research-informed clinical practice. Findings from this investigation demonstrate that embedding problem-based learning into prosthetics and orthotics students' curriculum has the potential to enhance students' learning experience, particularly students' evidence-based practice. This may lead to graduates who are more knowledgeable and thus who can offer the optimal patient care (i.e. clinical practice). © The International Society for Prosthetics and Orthotics 2014.

  6. The Clinical Research Office of the Endourological Society Ureteroscopy Global Study: Indications, Complications, and Outcomes in 11885 Patients

    DEFF Research Database (Denmark)

    De La Rosette, Jean; Denstedt, John D; Geavlete, Petrisor A

    2013-01-01

    Purpose: To assess the current indications for ureteroscopy (URS) treatment, outcome in terms of stone-free rate, and intra- and postoperative complications using the modified Clavien grading system. Patients and Methods: The Clinical Research Office of the Endourological Society (CROES) collected...... prospective data as part of the URS Global Study for consecutive patients treated with URS at centers around the world for 1 year. URS was performed according to study protocol and local clinical practice guidelines. Stone size and location were recorded and postoperative outcome and complications, graded...

  7. The psychological profile of parents who volunteer their children for clinical research: a controlled study.

    Science.gov (United States)

    Harth, S C; Johnstone, R R; Thong, Y H

    1992-06-01

    Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. The responses of these parents to the Gordon Survey of Interpersonal Values Questionnaire, the Coopersmith Self-Esteem Inventory and the Cattell Sixteen Personality Factor Questionnaire were analysed by computer. There was a marked difference between the psychological profiles of the two groups of parents. Volunteering parents put more value on benevolence while non-volunteering parents were more concerned with power and prestige. The self-esteem of volunteering parents was much lower than that of non-volunteering parents. Finally, volunteering parents were more introverted, exhibited greater anxiety and low supergo, while non-volunteering parents appeared to have greater social confidence and emotional stability. Since an individual's values, self-esteem and personality may be important antecedents of behaviour, these findings suggest that parents who volunteer their children for clinical research are not only socially disadvantaged and emotionally vulnerable, but may also be psychologically predisposed to volunteering. Furthermore, these findings provide evidence for the existence of a psychosocial 'filter' effect of the informed consent procedure, which may be discouraging the better educated, more privileged and psychologically resilient members of society from participation as research subjects.

  8. The psychological profile of parents who volunteer their children for clinical research: a controlled study.

    Science.gov (United States)

    Harth, S C; Johnstone, R R; Thong, Y H

    1992-01-01

    Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. The responses of these parents to the Gordon Survey of Interpersonal Values Questionnaire, the Coopersmith Self-Esteem Inventory and the Cattell Sixteen Personality Factor Questionnaire were analysed by computer. There was a marked difference between the psychological profiles of the two groups of parents. Volunteering parents put more value on benevolence while non-volunteering parents were more concerned with power and prestige. The self-esteem of volunteering parents was much lower than that of non-volunteering parents. Finally, volunteering parents were more introverted, exhibited greater anxiety and low supergo, while non-volunteering parents appeared to have greater social confidence and emotional stability. Since an individual's values, self-esteem and personality may be important antecedents of behaviour, these findings suggest that parents who volunteer their children for clinical research are not only socially disadvantaged and emotionally vulnerable, but may also be psychologically predisposed to volunteering. Furthermore, these findings provide evidence for the existence of a psychosocial 'filter' effect of the informed consent procedure, which may be discouraging the better educated, more privileged and psychologically resilient members of society from participation as research subjects. PMID:1619628

  9. A protocol for classifying normal- and flat-arched foot posture for research studies using clinical and radiographic measurements

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2009-07-01

    Full Text Available Abstract Background There are several clinical and radiological methods available to classify foot posture in research, however there is no clear strategy for selecting the most appropriate measurements. Therefore, the aim of this study was to develop a foot screening protocol to distinguish between participants with normal- and flat-arched feet who would then subsequently be recruited into a series of laboratory-based gait studies. Methods The foot posture of ninety-one asymptomatic young adults was assessed using two clinical measurements (normalised navicular height and arch index and four radiological measurements taken from antero-posterior and lateral x-rays (talus-second metatarsal angle, talo-navicular coverage angle, calcaneal inclination angle and calcaneal-first metatarsal angle. Normative foot posture values were taken from the literature and used to recruit participants with normal-arched feet. Data from these participants were subsequently used to define the boundary between normal- and flat-arched feet. This information was then used to recruit participants with flat-arched feet. The relationship between the clinical and radiographic measures of foot posture was also explored. Results Thirty-two participants were recruited to the normal-arched study, 31 qualified for the flat-arched study and 28 participants were classified as having neither normal- or flat-arched feet and were not suitable for either study. The values obtained from the two clinical and four radiological measurements established two clearly defined foot posture groups. Correlations among clinical and radiological measures were significant (p r = 0.24 to 0.70. Interestingly, the clinical measures were more strongly associated with the radiographic angles obtained from the lateral view. Conclusion This foot screening protocol provides a coherent strategy for researchers planning to recruit participants with normal- and flat-arched feet. However, further research is

  10. Database on veterinary clinical research in homeopathy.

    Science.gov (United States)

    Clausen, Jürgen; Albrecht, Henning

    2010-07-01

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

  11. Nuclear medical approaches to clinical research

    International Nuclear Information System (INIS)

    Otte, Andreas; Nguyen, Tristan

    2009-01-01

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

  12. Investigating the Experiences of Childhood Cancer Patients and Parents Participating in Optional Nontherapeutic Clinical Research Studies in the UK.

    Science.gov (United States)

    Errington, Julie; Malik, Ghada; Evans, Julie; Baston, Jenny; Parry, Annie; Price, Lisa; Johnstone, Hina; Peters, Selena; Oram, Victoria; Howe, Karen; Whiteley, Emma; Tunnacliffe, Jane; Veal, Gareth J

    2016-07-01

    While the majority of childhood cancer clinical trials are treatment related, additional optional research investigations may be carried out that do not directly impact on treatment. It is essential that these studies are conducted ethically and that the experiences of families participating in these studies are as positive as possible. A questionnaire study was carried out to investigate the key factors that influence why families choose to participate in optional nontherapeutic research studies, the level of understanding of the trials involved, and the experiences of participation. A total of 100 participants from six UK centers were studied; 77 parents, 10 patients >16 years, and 13 patients aged 8-15 years. Ninety-seven percent of parents and 90% of patients felt that information provided prior to study consent was of the right length, with 52% of parents and 65% of patients fully understanding the information provided. Seventy-four percent of parents participated in research studies in order to "do something important", while 74% of patients participated "to help medical staff". Encouragingly, <5% of participants felt that their clinical care would be negatively affected if they did not participate. Positive aspects of participation included a perception of increased attention from medical staff. Negative aspects included spending longer periods in hospital and the requirement for additional blood samples. Ninety-six percent of parents and 87% of patients would participate in future studies. The study provides an insight into the views of childhood cancer patients and their parents participating in nontherapeutic clinical research studies. Overwhelmingly, the findings suggest that participation is seen as a positive experience. © 2016 The Authors. Pediatric Blood & Cancer, published by Wiley Periodicals, Inc.

  13. Practitioner-Customizable Clinical Information Systems: A Case Study to Ground Further Research and Development Opportunities

    Directory of Open Access Journals (Sweden)

    Cecily Morrison

    2010-01-01

    Full Text Available The uptake of electronic records and information technology support in intensive care medicine has been slower than many people predicted. One of the engineering challenges to overcome has been the subtle, but important, variation in clinical practice in different units. A relatively recent innovation that addresses this challenge is practitioner-customizable clinical information systems, allowing clinicians wide scope in adjusting their systems to suit their clinical practice. However, these systems present a significant design challenge, not only of added technical complexity, but in providing tools that support clinicians in doing many of the tasks of a software engineer. This paper reviews the use of a commercially available clinical information system that is intended to be practitioner-customizable, and considers the further design and development of tools to support healthcare practitioners doing end-user customization on their own clinical information systems.

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

    Science.gov (United States)

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

    2016-06-01

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

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

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

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

  16. Increasing recruitment rates in an inpatient clinical research study using quality improvement methods.

    Science.gov (United States)

    Sauers, Hadley S; Beck, Andrew F; Kahn, Robert S; Simmons, Jeffrey M

    2014-11-01

    One important benefit of successful patient recruitment is increased generalizability of findings. We sought to optimize enrollment of children admitted with asthma as part of a population-based, prospective, observational cohort study with the goal of enrolling at least 60% of all eligible and staffed patients. Quality improvement methods were used to improve cohort recruitment. Weekly meetings with study staff and study leadership were held to plan and discuss how to maximize recruitment rates. Significant initial variability in recruitment success prompted the team to use small-scale tests of change to increase recruitment numbers. A number of tests were trialed, focusing primarily on reducing patient refusals and improving recruitment process efficiency. Recruitment rates were calculated by dividing eligible by enrolled patients and displayed using annotated Shewhart control charts. Control charts were used to illustrate week-to-week variability while also enabling differentiation of common-cause and special-cause variation. The study enrolled 774 patients, representing 54% of all eligible and 59% of those eligible for whom staff were available to enroll. Our mean weekly recruitment rate increased from 55% during the first 3 months of the study to a statistically significant sustained rate of 61%. This was sustained given numerous obstacles, such as departing and hiring of staff and adding a second recruitment location. Implementing quality improvement methods within a larger research study led to an increase in the rate of recruitment as well as the stability in recruitment rates from week-to-week. Copyright © 2014 by the American Academy of Pediatrics.

  17. Current trends in research and clinical issues in the study of personality and its disorders

    DEFF Research Database (Denmark)

    Simonsen, Erik; Sørensen, Per; Pedersen, Liselotte

    2014-01-01

    lecture (Simonsen), a young researchers' symposium (Hopwood, Sharp, and Kaess), and special lectures on the Danish philosopher Soeren Kierkegaard and the poet Hans Christian Andersen. In this article we will survey the presentations and highlight the important issues in order to underline the current......The International Society for the Study of Personality Disorders (ISSPD) celebrated its 25th anniversary in September 2013 in Copenhagen and commemorated the First International Congress at the same site. The overall theme of the congress was "Bridging Personality and Psychopathology: The Person...... Behind the Illness." More than 400 abstracts were submitted, and the program included 8 keynote presentations, 18 invited symposia, a debate on current controversial issues in the classification of personality disorders (Fossati, Tyrer, Livesley, and Krueger), an ISSPD award lecture (Silk), a jubilee...

  18. Linking a research register to clinical records in older adults' mental health services:a mixed-methods study

    OpenAIRE

    Robotham, Dan; Evans, Joanne; Watson, Andrew; Perdue, Iain; Craig, Thomas; Rose, Diana; Wykes, Til

    2015-01-01

    INTRODUCTION: Patients can provide consent to have their clinical records linked to a research register, a process known as consent for contact (C4C). There is evidence about how to engage people with mental illness in C4C, but nothing specific to older adults. This is a priority area for research (for example, dementia trials), although sign-up rates to C4C are lower than for younger populations. Through this study we seek to understand these disparities.METHODS: This was a two-stage cross-s...

  19. A qualitative study examining methods of accessing and identifying research relevant to clinical practice among rehabilitation clinicians.

    Science.gov (United States)

    Patel, Drasti; Koehmstedt, Christine; Jones, Rebecca; Coffey, Nathan T; Cai, Xinsheng; Garfinkel, Steven; Shaewitz, Dahlia M; Weinstein, Ali A

    2017-01-01

    Research examining the utilization of evidence-based practice (EBP) specifically among rehabilitation clinicians is limited. The objective of this study was to examine how various rehabilitative clinicians including physical therapists, occupational therapists, rehabilitation counselors, and physiatrists are gaining access to literature and whether they are able to implement the available research into practice. A total of 21 total clinicians were interviewed via telephone. Using NVivo, a qualitative analysis of the responses was performed. There were similarities found with respect to the information-seeking behaviors and translation of research across the different clinician types. Lack of time was reported to be a barrier for both access to literature and implementation of research across all clinician types. The majority of clinicians who reported having difficulty with utilizing the published literature indicated that the literature was not applicable to their practice, the research was not specific enough to be put into practice, or the research found was too outdated to be relevant. In addition, having a supportive work environment aided in the search and utilization of research through providing resources central to assisting clinicians in gaining access to health information. Our study identified several barriers that affect EBP for rehabilitation clinicians. The findings suggest the need for researchers to ensure that their work is applicable and specific to clinical practice for implementation to occur.

  20. Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.

    Science.gov (United States)

    Kiringoda, Ruwan; Thurm, Audrey E; Hirschtritt, Matthew E; Koziol, Deloris; Wesley, Robert; Swedo, Susan E; O'Grady, Naomi P; Quezado, Zenaide M N

    2010-06-01

    To quantify the incidence of adverse events associated with anesthesia given for research-driven imaging studies and to identify risk factors for those events in pediatric research subjects. Retrospective cohort study. National Institutes of Health Clinical Center. Children and adolescents enrolled in clinical research protocols who required anesthesia for research-related imaging studies from January 2000 to September 2008. Propofol sedation/anesthesia. The occurrence of respiratory, cardiovascular, and all anesthesia-related adverse events that required intervention while receiving anesthetics for research-driven imaging studies and other noninvasive procedures. We identified 607 children who received 1480 propofol anesthetic procedures for imaging studies. Seventy percent of anesthetics were given to subjects with severe diseases and significant disabilities (American Society of Anesthesiologists Physical Status [ASA] III). Anesthesia had a mean (SD) duration of 115 (55) minutes, and in 12.5% of procedures, an airway device was necessary. There were 98 notable respiratory, cardiovascular, and other events in 79 anesthetic procedures, a rate of 534 per 10 000 anesthetic procedures with 1 or more adverse events. There was no long-lasting morbidity or mortality. The ASA classification (odds ratio [OR], 2.92; 95% confidence interval [CI], 1.24-6.88), anesthetic effect duration (OR, 1.46; 95% CI, 1.25-1.70), and presence of airway abnormalities (OR, 4.41; 95% CI, 1.60-12.12) were independently associated with adverse events during anesthetic use. In our clinical research sample of high-risk children who received sedation/anesthesia by an anesthesiologist, we observed a low incidence of adverse events and no long-term complications. Risk factors for adverse events included higher ASA classification, increasing anesthetic duration, and presence of airway abnormalities.

  1. Use of the i2b2 research query tool to conduct a matched case-control clinical research study: advantages, disadvantages and methodological considerations.

    Science.gov (United States)

    Johnson, Emilie K; Broder-Fingert, Sarabeth; Tanpowpong, Pornthep; Bickel, Jonathan; Lightdale, Jenifer R; Nelson, Caleb P

    2014-01-30

    A major aim of the i2b2 (informatics for integrating biology and the bedside) clinical data informatics framework aims to create an efficient structure within which patients can be identified for clinical and translational research projects.Our objective was to describe the respective roles of the i2b2 research query tool and the electronic medical record (EMR) in conducting a case-controlled clinical study at our institution. We analyzed the process of using i2b2 and the EMR together to generate a complete research database for a case-control study that sought to examine risk factors for kidney stones among gastrostomy tube (G-tube) fed children. Our final case cohort consisted of 41/177 (23%) of potential cases initially identified by i2b2, who were matched with 80/486 (17%) of potential controls. Cases were 10 times more likely to be excluded for inaccurate coding regarding stones vs. inaccurate coding regarding G-tubes. A majority (67%) of cases were excluded due to not meeting clinical inclusion criteria, whereas a majority of control exclusions (72%) occurred due to inadequate clinical data necessary for study completion. Full dataset assembly required complementary information from i2b2 and the EMR. i2b2 was critical as a query analysis tool for patient identification in our case-control study. Patient identification via procedural coding appeared more accurate compared with diagnosis coding. Completion of our investigation required iterative interplay of i2b2 and the EMR to assemble the study cohort.

  2. The acceptability among health researchers and clinicians of social media to translate research evidence to clinical practice: mixed-methods survey and interview study.

    Science.gov (United States)

    Tunnecliff, Jacqueline; Ilic, Dragan; Morgan, Prue; Keating, Jennifer; Gaida, James E; Clearihan, Lynette; Sadasivan, Sivalal; Davies, David; Ganesh, Shankar; Mohanty, Patitapaban; Weiner, John; Reynolds, John; Maloney, Stephen

    2015-05-20

    Establishing and promoting connections between health researchers and health professional clinicians may help translate research evidence to clinical practice. Social media may have the capacity to enhance these connections. The aim of this study was to explore health researchers' and clinicians' current use of social media and their beliefs and attitudes towards the use of social media for communicating research evidence. This study used a mixed-methods approach to obtain qualitative and quantitative data. Participation was open to health researchers and clinicians. Data regarding demographic details, current use of social media, and beliefs and attitudes towards the use of social media for professional purposes were obtained through an anonymous Web-based survey. The survey was distributed via email to research centers, educational and clinical institutions, and health professional associations in Australia, India, and Malaysia. Consenting participants were stratified by country and role and selected at random for semistructured telephone interviews to explore themes arising from the survey. A total of 856 participants completed the questionnaire with 125 participants declining to participate, resulting in a response rate of 87.3%. 69 interviews were conducted with participants from Australia, India, and Malaysia. Social media was used for recreation by 89.2% (749/840) of participants and for professional purposes by 80.0% (682/852) of participants. Significant associations were found between frequency of professional social media use and age, gender, country of residence, and graduate status. Over a quarter (26.9%, 229/852) of participants used social media for obtaining research evidence, and 15.0% (128/852) of participants used social media for disseminating research evidence. Most participants (95.9%, 810/845) felt there was a role for social media in disseminating or obtaining research evidence. Over half of the participants (449/842, 53.3%) felt they had a

  3. Investigating the effect of clinical governess approach on patients' length of stay in emergency department: an action research study.

    Directory of Open Access Journals (Sweden)

    Tahmine Salehi

    2014-02-01

    Full Text Available Over the past decade, clinical governance approach with aims to improve the quality of health services has been proposed in Iran. Considering the obvious problems especially patients' length of stay (LOS in the emergency departments (EDs; the present study has been carried out with the purpose of Investigating the effect of clinical governess approach on patients' LOS in the one of the largest medical centers in the country. After the problem was specified by the 17 interviews with employees and managers of the ED; the emergency clinical governance committee was formed by two academic researchers and seven ED staff (key participants that had the most involvement with the subject of study. The activities of the committee, including planning, acting, observing and reflecting, was organized by using participatory action research approach and action research cycle (Kemmis 1995. During this time, three formal meetings with key participants were held in 6-month intervals. Monthly records of patients' average LOS and interview with ED staff were used to analyze the findings. The research was completed with two cycles in one year. Committee members took the following actions. As a result, the patients' LOS reduced from 2.68 days to 1.73 days. Make regular patients visits by medical groups especially orthopedists and neurologists; Decision making about patients situation by emergency physicians and transferring patients to the relevant units by bed managers; Refusing to admit elective patients during overcrowding times; to regulate the list of patients requiring ICU by anesthesiologists. Prolonged LOS can be due to various causes and a team approach, which is one of the requirements of clinical governance approach, is needed to manage it. The results showed that the multidisciplinary team could make positive changes and reduce LOS in emergency setting.

  4. A qualitative study examining methods of accessing and identifying research relevant to clinical practice among rehabilitation clinicians

    Directory of Open Access Journals (Sweden)

    Patel D

    2017-12-01

    Full Text Available Drasti Patel,1 Christine Koehmstedt,1 Rebecca Jones,1 Nathan T Coffey,1 Xinsheng Cai,2 Steven Garfinkel,2 Dahlia M Shaewitz,2 Ali A Weinstein1 1Center for Study of Chronic Illness and Disability, College of Health and Human Services, George Mason University, Fairfax, VA, 2American Institutes for Research, Washington, DC, USA Purpose: Research examining the utilization of evidence-based practice (EBP specifically among rehabilitation clinicians is limited. The objective of this study was to examine how various rehabilitative clinicians including physical therapists, occupational therapists, rehabilitation counselors, and physiatrists are gaining access to literature and whether they are able to implement the available research into practice.Methods: A total of 21 total clinicians were interviewed via telephone. Using NVivo, a qualitative analysis of the responses was performed.Results: There were similarities found with respect to the information-seeking behaviors and translation of research across the different clinician types. Lack of time was reported to be a barrier for both access to literature and implementation of research across all clinician types. The majority of clinicians who reported having difficulty with utilizing the published literature indicated that the literature was not applicable to their practice, the research was not specific enough to be put into practice, or the research found was too outdated to be relevant. In addition, having a supportive work environment aided in the search and utilization of research through providing resources central to assisting clinicians in gaining access to health information.Conclusion: Our study identified several barriers that affect EBP for rehabilitation clinicians. The findings suggest the need for researchers to ensure that their work is applicable and specific to clinical practice for implementation to occur. Keywords: health information, information behavior, knowledge utilization

  5. Clinical trial aims to study immunotherapy for central nervous system tumors | Center for Cancer Research

    Science.gov (United States)

    A new clinical trial aims to determine whether nivolumab, an immune checkpoint inhibitor, can improve control of cancer for patients with several types of tumors of the central nervous system (CNS). The CNS is composed of the brain and spinal cord and the cause of most CNS tumors in adults is unknown. Learn more...

  6. Alternatives to current flow cytometry data analysis for clinical and research studies.

    Science.gov (United States)

    Gondhalekar, Carmen; Rajwa, Bartek; Patsekin, Valery; Ragheb, Kathy; Sturgis, Jennifer; Robinson, J Paul

    2018-02-01

    Flow cytometry has well-established methods for data analysis based on traditional data collection techniques. These techniques typically involved manual insertion of tube samples into an instrument that, historically, could only measure 1-3 colors. The field has since evolved to incorporate new technologies for faster and highly automated sample preparation and data collection. For example, the use of microwell plates on benchtop instruments is now a standard on virtually every new instrument, and so users can easily accumulate multiple data sets quickly. Further, because the user must carefully define the layout of the plate, this information is already defined when considering the analytical process, expanding the opportunities for automated analysis. Advances in multi-parametric data collection, as demonstrated by the development of hyperspectral flow-cytometry, 20-40 color polychromatic flow cytometry, and mass cytometry (CyTOF), are game-changing. As data and assay complexity increase, so too does the complexity of data analysis. Complex data analysis is already a challenge to traditional flow cytometry software. New methods for reviewing large and complex data sets can provide rapid insight into processes difficult to define without more advanced analytical tools. In settings such as clinical labs where rapid and accurate data analysis is a priority, rapid, efficient and intuitive software is needed. This paper outlines opportunities for analysis of complex data sets using examples of multiplexed bead-based assays, drug screens and cell cycle analysis - any of which could become integrated into the clinical environment. Copyright © 2017. Published by Elsevier Inc.

  7. Stuttering: Clinical and research update.

    Science.gov (United States)

    Perez, Hector R; Stoeckle, James H

    2016-06-01

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

  8. NIH Clinical Research Trials and You

    Science.gov (United States)

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

  9. Identifying appropriate reference data models for comparative effectiveness research (CER) studies based on data from clinical information systems.

    Science.gov (United States)

    Ogunyemi, Omolola I; Meeker, Daniella; Kim, Hyeon-Eui; Ashish, Naveen; Farzaneh, Seena; Boxwala, Aziz

    2013-08-01

    The need for a common format for electronic exchange of clinical data prompted federal endorsement of applicable standards. However, despite obvious similarities, a consensus standard has not yet been selected in the comparative effectiveness research (CER) community. Using qualitative metrics for data retrieval and information loss across a variety of CER topic areas, we compare several existing models from a representative sample of organizations associated with clinical research: the Observational Medical Outcomes Partnership (OMOP), Biomedical Research Integrated Domain Group, the Clinical Data Interchange Standards Consortium, and the US Food and Drug Administration. While the models examined captured a majority of the data elements that are useful for CER studies, data elements related to insurance benefit design and plans were most detailed in OMOP's CDM version 4.0. Standardized vocabularies that facilitate semantic interoperability were included in the OMOP and US Food and Drug Administration Mini-Sentinel data models, but are left to the discretion of the end-user in Biomedical Research Integrated Domain Group and Analysis Data Model, limiting reuse opportunities. Among the challenges we encountered was the need to model data specific to a local setting. This was handled by extending the standard data models. We found that the Common Data Model from the OMOP met the broadest complement of CER objectives. Minimal information loss occurred in mapping data from institution-specific data warehouses onto the data models from the standards we assessed. However, to support certain scenarios, we found a need to enhance existing data dictionaries with local, institution-specific information.

  10. Clinical Orofacial Examination in Juvenile Idiopathic Arthritis: International Consensus-based Recommendations for Monitoring Patients in Clinical Practice and Research Studies.

    Science.gov (United States)

    Stoustrup, Peter; Twilt, Marinka; Spiegel, Lynn; Kristensen, Kasper Dahl; Koos, Bernd; Pedersen, Thomas Klit; Küseler, Annelise; Cron, Randy Q; Abramowicz, Shelly; Verna, Carlalberta; Peltomäki, Timo; Alstergren, Per; Petty, Ross; Ringold, Sarah; Nørholt, Sven Erik; Saurenmann, Rotraud K; Herlin, Troels

    2017-03-01

    To develop international consensus-based recommendations for the orofacial examination of patients with juvenile idiopathic arthritis (JIA), for use in clinical practice and research. Using a sequential phased approach, a multidisciplinary task force developed and evaluated a set of recommendations for the orofacial examination of patients with JIA. Phase 1: A Delphi survey was conducted among 40 expert physicians and dentists with the aim of identifying and ranking the importance of items for inclusion. Phase 2: The task force developed consensus about the domains and items to be included in the recommendations. Phase 3: A systematic literature review was performed to assess the evidence supporting the consensus-based recommendations. Phase 4: An independent group of orofacial and JIA experts were invited to assess the content validity of the task force's recommendations. Five recommendations were developed to assess the following 5 domains: medical history, orofacial symptoms, muscle and temporomandibular joint function, orofacial function, and dentofacial growth. After application of data search criteria, 56 articles were included in the systematic review. The level of evidence for the 5 recommendations was derived primarily from descriptive studies, such as cross-sectional and case-control studies. Five recommendations are proposed for the orofacial examination of patients with JIA to improve the clinical practice and aid standardized data collection for future studies. The task force has formulated a future research program based on the proposed recommendations.

  11. Retooling Institutional Support Infrastructure for Clinical Research

    Science.gov (United States)

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

    2016-01-01

    Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can detract investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a transition to unified research support. PMID:27125563

  12. Immunization in pregnancy clinical research in low- and middle-income countries - Study design, regulatory and safety considerations.

    Science.gov (United States)

    Kochhar, Sonali; Bonhoeffer, Jan; Jones, Christine E; Muñoz, Flor M; Honrado, Angel; Bauwens, Jorgen; Sobanjo-Ter Meulen, Ajoke; Hirschfeld, Steven

    2017-12-04

    Immunization of pregnant women is a promising public health strategy to reduce morbidity and mortality among both the mothers and their infants. Establishing safety and efficacy of vaccines generally uses a hybrid design between a conventional interventional study and an observational study that requires enrolling thousands of study participants to detect an unknown number of uncommon events. Historically, enrollment of pregnant women in clinical research studies encountered many barriers based on risk aversion, lack of knowledge, and regulatory ambiguity. Conducting research enrolling pregnant women in low- and middle-income countries can have additional factors to address such as limited availability of baseline epidemiologic data on disease burden and maternal and neonatal outcomes during and after pregnancy; challenges in recruiting and retaining pregnant women in research studies, variability in applying and interpreting assessment methods, and variability in locally acceptable and available infrastructure. Some measures to address these challenges include adjustment of study design, tailoring recruitment, consent process, retention strategies, operational and logistical processes, and the use of definitions and data collection methods that will align with efforts globally. Copyright © 2017. Published by Elsevier Ltd.

  13. Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

    DEFF Research Database (Denmark)

    Jones, Roy; Wilkinson, David; Lopez, Oscar L

    2011-01-01

    Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. Data mining projects sponsored by industry that use these databases, however, are often not viewed favourably in the academic medical...... community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here...

  14. Reorganizing the General Clinical Research Center to improve the clinical and translational research enterprise.

    Science.gov (United States)

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

    2013-12-01

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

  15. A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

    Science.gov (United States)

    Kass, Nancy E; Taylor, Holly A; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

    2015-02-01

    Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples. © The Author(s) 2014.

  16. Challenges in collecting clinical samples for research from pregnant women of South Asian origin: evidence from a UK study.

    Science.gov (United States)

    Neelotpol, Sharmind; Hay, Alastair W M; Jolly, A Jim; Woolridge, Mike W

    2016-08-31

    To recruit South Asian pregnant women, living in the UK, into a clinicoepidemiological study for the collection of lifestyle survey data and antenatal blood and to retain the women for the later collection of cord blood and meconium samples from their babies for biochemical analysis. A longitudinal study recruiting pregnant women of South Asian and Caucasian origin living in the UK. Recruitment of the participants, collection of clinical samples and survey data took place at the 2 sites within a single UK Northern Hospital Trust. Pregnant women of South Asian origin (study group, n=98) and of Caucasian origin (comparison group, n=38) living in Leeds, UK. Among the participants approached, 81% agreed to take part in the study while a 'direct approach' method was followed. The retention rate of the participants was a remarkable 93.4%. The main challenges in recruiting the ethnic minority participants were their cultural and religious conservativeness, language barrier, lack of interest and feeling of extra 'stress' in taking part in research. The chief investigator developed an innovative participant retention method, associated with the women's cultural and religious practices. The method proved useful in retaining the participants for about 5 months and in enabling successful collection of clinical samples from the same mother-baby pairs. The collection of clinical samples and lifestyle data exceeded the calculated sample size required to give the study sufficient power. The numbers of samples obtained were: maternal blood (n=171), cord blood (n=38), meconium (n=176), lifestyle questionnaire data (n=136) and postnatal records (n=136). Recruitment and retention of participants, according to the calculated sample size, ensured sufficient power and success for a clinicoepidemiological study. Results suggest that development of trust and confidence between the participant and the researcher is the key to the success of a clinical and epidemiological study involving

  17. Conducting Clinical Research Using Crowdsourced Convenience Samples.

    Science.gov (United States)

    Chandler, Jesse; Shapiro, Danielle

    2016-01-01

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

  18. Evaluation of Hanau's formula in determination of lateral condylar guidance: A clinical research study

    Science.gov (United States)

    Bhawsar, Sanjay Vasant; Marathe, Ashlesha Subhash; Ansari, Sadekh Abdul

    2015-01-01

    Statement of Problem: The accuracy and reliability of the methods used for programming the semi-adjustable articulators determine the accuracy in occlusion. The current recommended average settings using the Hanau's formula commonly used by clinicians is questionable, and thus reassessment is needed. This study was carried out to evaluate and compare the lateral condylar guidance: (1) Using the Hanau's formula and the computerized jaw tracking device (Kinesiograph). (2) On the right and left sides using both these methods. Materials and Methods: A total of 20 completely edentulous patients (14 male and 6 females) within 40–60 years of age were selected. Jaw relation was recorded followed by face bow transfer. Extraoral Gothic arch tracing was recorded; three protrusive records were obtained and condylar guidance was calculated. Lateral condylar guidance was then calculated using Hanau's formula, followed by the computerized jaw tracking device. A comparative evaluation was done of the obtained values. The same investigator worked with each of the study participants for the purpose of standardization. Results: The lateral condylar guidance values obtained using the Hanau's formula ranged from 14 to 17° while those obtained using the computerized K7 jaw tracking device ranged from 8 to 40°. Bennett angle values, obtained using the jaw tracking device and Hanau's formula showed statistically significant differences (P 0.05). Conclusion: Based on the results, dentist and dental technicians should consider reassessing the current recommended average settings and use of the Hanau's formula for programming the semi-adjustable articulators. PMID:26929535

  19. Research and clinical practice relationship

    Directory of Open Access Journals (Sweden)

    Ashammakhi N

    2008-01-01

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

  20. Case Study in Designing a Research Fundamentals Curriculum for Community Health Workers: A University - Community Clinic Collaborative

    Science.gov (United States)

    Dumbauld, Jill; Kalichman, Michael; Bell, Yvonne; Dagnino, Cynthia; Taras, Howard

    2014-01-01

    Introduction Community health workers are increasingly incorporated into research teams. Training them in research methodology and ethics, while relating these themes to a community’s characteristics, may help to better integrate these health promotion personnel into research teams. Approach and Strategies This pilot project involved the design and implementation of an interactive training course on research fundamentals for community health workers from clinics in a rural, predominately Latino setting. Curriculum development was guided by collaborative activities arising from a university - clinic partnership, a community member focus group, and the advice of community-based researchers. The resulting curriculum was interactive and stimulated dialogue between trainees and academic researchers. Discussion and Conclusions Collaboration between researchers and health agency professionals proved to be a practical method to develop curriculum for clinic staff. An interactive curriculum allowed trainees to incorporate community-specific themes into the discussion. This interaction educated course instructors from academia about the community as much as it educated course participants about research. The bidirectional engagement that occurs during the development and teaching of this course can potentially lead to research partnerships between community agencies and academia, better-informed members of the public, and research protocols that accommodate community characteristics. PMID:24121537

  1. Percutaneous nephrolithotomy among patients with renal anomalies: patient characteristics and outcomes; a subgroup analysis of the clinical research office of the endourological society global percutaneous nephrolithotomy study

    DEFF Research Database (Denmark)

    Osther, Palle Jörn; Razvi, Hassan; Liatsikos, Evangelos

    2011-01-01

    This study compared the characteristics and outcomes of percutaneous nephrolithotomy (PCNL) in patients with and without renal malformations using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database.......This study compared the characteristics and outcomes of percutaneous nephrolithotomy (PCNL) in patients with and without renal malformations using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database....

  2. Electronic health records to facilitate clinical research.

    Science.gov (United States)

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

    2017-01-01

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

  3. Clinical outcomes research in gynecologic oncology.

    Science.gov (United States)

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

    2017-09-01

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

  4. Modern Clinical Research on LSD

    OpenAIRE

    Liechti, Matthias E.

    2017-01-01

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

  5. The Clinical Research Landscape in Rhode Island.

    Science.gov (United States)

    Mao, George; Ramratnam, Bharat

    2017-01-06

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

  6. A cross-sectional multicenter study of osteogenesis imperfecta in North America - results from the linked clinical research centers.

    Science.gov (United States)

    Patel, R M; Nagamani, S C S; Cuthbertson, D; Campeau, P M; Krischer, J P; Shapiro, J R; Steiner, R D; Smith, P A; Bober, M B; Byers, P H; Pepin, M; Durigova, M; Glorieux, F H; Rauch, F; Lee, B H; Hart, T; Sutton, V R

    2015-02-01

    Osteogenesis imperfecta (OI) is the most common skeletal dysplasia that predisposes to recurrent fractures and bone deformities. In spite of significant advances in understanding the genetic basis of OI, there have been no large-scale natural history studies. To better understand the natural history and improve the care of patients, a network of Linked Clinical Research Centers (LCRC) was established. Subjects with OI were enrolled in a longitudinal study, and in this report, we present cross-sectional data on the largest cohort of OI subjects (n = 544). OI type III subjects had higher prevalence of dentinogenesis imperfecta, severe scoliosis, and long bone deformities as compared to those with OI types I and IV. Whereas the mean lumbar spine area bone mineral density (LS aBMD) was low across all OI subtypes, those with more severe forms had lower bone mass. Molecular testing may help predict the subtype in type I collagen-related OI. Analysis of such well-collected and unbiased data in OI can not only help answering questions that are relevant to patient care but also foster hypothesis-driven research, especially in the context of 'phenotypic expansion' driven by next-generation sequencing. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. A Cross-sectional Multicenter Study of Osteogenesis Imperfecta in North America – Results from the Linked Clinical Research Centers

    Science.gov (United States)

    Patel, Ronak M; Nagamani, Sandesh CS; Cuthbertson, David; Campeau, Philippe M; Krischer, Jeffrey P; Shapiro, Jay R; Steiner, Robert D; Smith, Peter A; Bober, Michael B; Byers, Peter H; Pepin, Melanie; Durigova, Michaela; Glorieux, Francis H; Rauch, Frank; Lee, Brendan H; Smith, Tracy; Sutton, V. Reid

    2017-01-01

    Osteogenesis Imperfecta (OI) is the most common skeletal dysplasia that predisposes to recurrent fractures and bone deformities. In spite of significant advances in understanding the genetic basis of OI, there have been no large-scale natural history studies. To better understand the natural history and improve the care of patients, a network of Linked Clinical Research Centers (LCRC) was established. Subjects with OI were enrolled in a longitudinal study, and in this report, we present cross-sectional data on the largest cohort of OI subjects (n=544). OI type III subjects had higher prevalence of dentinogenesis imperfecta, severe scoliosis, and long bone deformities as compared to those with OI types I and IV. Whereas the mean LS aBMD was low across all OI subtypes, those with more severe forms had lower bone mass. Molecular testing may help predict the subtype in type I collagen-related OI. Analysis of such well-collected and unbiased data in OI can not only help answer questions that are relevant to patient care but also foster hypothesis-driven research, especially in the context of “phenotypic expansion” driven by next-generation sequencing. PMID:24754836

  8. Linking a research register to clinical records in older adults' mental health services: a mixed-methods study.

    Science.gov (United States)

    Robotham, Dan; Evans, Joanne; Watson, Andrew; Perdue, Iain; Craig, Thomas; Rose, Diana; Wykes, Til

    2015-01-01

    Patients can provide consent to have their clinical records linked to a research register, a process known as consent for contact (C4C). There is evidence about how to engage people with mental illness in C4C, but nothing specific to older adults. This is a priority area for research (for example, dementia trials), although sign-up rates to C4C are lower than for younger populations. Through this study we seek to understand these disparities. This was a two-stage cross-sectional observational study. In phase one, focus groups with service users, carers and clinicians informed a framework for clinicians to explain C4C to those on their caseload. In phase two, clinicians explained C4C to 26 service users (and carers where applicable). These conversations were recorded, and their content was analysed. Service users and carers were then interviewed to provide further feedback on their conversations with clinicians. A total of 31 service users, 24 carers and 13 clinical staff took part across the two phases. In phase one, service users and carers sought assurance of the right to refuse participation in further studies (after joining C4C). Clinicians expressed concerns over legal and practical implications of ascertaining mental capacity and best interest. In phase two, clinicians' explanations were less thorough than similar explanations given to younger adults with psychosis. Clinicians omitted details of service users' right to stipulate contact arrangements, which was significantly associated with whether service users/carers agreed to join. Common reasons for joining C4C included altruism and the chance to speak to new people. Few participants refused to join, but reasons included avoidance of stress (potentially alleviated through the presence of a carer). Implementing C4C in older adults' services requires clinicians to deliver concise, simple explanations to individuals and their carers where applicable. Older adults can be suspicious of unsolicited contact; thus

  9. Supine Versus Prone Position During Percutaneous Nephrolithotomy: A Report from the Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study

    DEFF Research Database (Denmark)

    G. Vadivia, José; M. Scarpa, Roberto; Duvdevani, Mordechai

    2011-01-01

    To determine differences in patients' characteristics, operative time and procedures, and perioperative outcomes between prone and supine positioning in percutaneous nephrolithotomy (PCNL) using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database....

  10. Giving voice to study volunteers: comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research.

    Science.gov (United States)

    Roberts, Laura Weiss; Kim, Jane Paik

    2014-09-01

    Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical

  11. Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

    Directory of Open Access Journals (Sweden)

    Jones Roy

    2011-10-01

    Full Text Available Abstract Background Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. Data mining projects sponsored by industry that use these databases, however, are often not viewed favourably in the academic medical community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here a successful example of this type of collaboration in the field of dementia. Methods The Donepezil Data Repository comprised 18 randomised, controlled trials conducted between 1991 and 2005. The project team at Pfizer determined that the data mining process should be guided by a diverse group of leading Alzheimer's disease clinical researchers called the "Expert Working Group." After development of a list of potential faculty members, invitations were extended and a group of seven members was assembled. The Working Group met regularly with Eisai/Pfizer clinicians and statisticians to discuss the data, identify issues that were currently of interest in the academic and clinical communities that might lend themselves to investigation using these data, and note gaps in understanding or knowledge of Alzheimer's disease that these data could address. Leadership was provided by the Pfizer Clinical Development team leader; Working Group members rotated responsibility for being lead and co-lead for each investigation and resultant publication. Results Six manuscripts, each published in a leading subspecialty journal, resulted from the group's work. Another project resulted in poster presentations at international congresses and two were cancelled due to resource constraints. Conclusions The experience represents a particular approach to

  12. Do countries rely on the World Health Organization for translating research findings into clinical guidelines? A case study.

    Science.gov (United States)

    Noor, Ramadhani A; Geldsetzer, Pascal; Bärnighausen, Till; Fawzi, Wafaie

    2016-10-06

    The World Health Organization's (WHO) antiretroviral therapy (ART) guidelines have generally been adopted rapidly and with high fidelity by countries in sub-Saharan Africa. Thus far, however, WHO has not published specific guidance on nutritional care and support for (non-pregnant) adults living with HIV despite a solid evidence base for some interventions. This offers an opportunity for a case study on whether national clinical guidelines in sub-Saharan Africa provide concrete recommendations in the face of limited guidance by WHO. This study, therefore, aims to determine if national HIV treatment guidelines in sub-Saharan Africa contain specific guidance on nutritional care and support for non-pregnant adults living with HIV. We identified the most recent national HIV treatment guidelines in sub-Saharan African countries with English as an official language. Using pre-specified criteria, we determined for each guideline whether it provides guidance to clinicians on each of five components of nutritional care and support for adults living with HIV: assessment of nutritional status, dietary counseling, micronutrient supplementation, ready-to-use therapeutic or supplementary foods, and food subsidies. We found that national HIV treatment guidelines in sub-Saharan Africa generally do not contain concrete recommendations on nutritional care and support for non-pregnant adults living with HIV. Given that decisions on nutritional care and support are inevitably being made at the clinician-patient level, and that clinicians have a relative disadvantage in systematically identifying, summarizing, and weighing up research evidence compared to WHO and national governments, there is a need for more specific clinical guidance. In our view, such guidance should at a minimum recommend daily micronutrient supplements for adults living with HIV who are in pre-ART stages, regular dietary counseling, periodic assessment of anthropometric status, and additional nutritional

  13. The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics

    Science.gov (United States)

    Rasmussen-Torvik, Laura J; Harmata, Emily E; Pardee, Roy; Saizan, Rosalinde; Malanga, Elisha; Sturtevant, Jessica L; Horgan, Casie E; Anau, Jane; Janning, Cheri D; Wellman, Robert D; Coley, R Yates; Cook, Andrea J; Courcoulas, Anita P; Coleman, Karen J; Williams, Neely A; McTigue, Kathleen M; Arterburn, David; McClay, James

    2017-01-01

    Background Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). Objective The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures—adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)—to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. Methods We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients’ electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. Results A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg

  14. Comparing student clinical self-efficacy and team process outcomes for a DEU, blended, and traditional clinical setting: A quasi-experimental research study.

    Science.gov (United States)

    Plemmons, Christina; Clark, Michele; Feng, Du

    2018-03-01

    Clinical education is vital to both the development of clinical self-efficacy and the integration of future nurses into health care teams. The dedicated education unit clinical teaching model is an innovative clinical partnership, which promotes skill development, professional growth, clinical self-efficacy, and integration as a team member. Blended clinical teaching models are combining features of the dedicated education unit and traditional clinical model. The aims of this study are to explore how each of three clinical teaching models (dedicated education unit, blended, traditional) affects clinical self-efficacy and attitude toward team process, and to compare the dedicated education unit model and blended model to traditional clinical. A nonequivalent control-group quasi-experimental design was utilized. The convenience sample of 272 entry-level baccalaureate nursing students included 84 students participating in a dedicated education unit model treatment group, 66 students participating in a blended model treatment group, and 122 students participating in a traditional model control group. Perceived clinical self-efficacy was evaluated by the pretest/posttest scores obtained on the General Self-Efficacy scale. Attitude toward team process was evaluated by the pretest/posttest scores obtained on the TeamSTEPPS® Teamwork Attitude Questionnaire. All three clinical teaching models resulted in significant increases in both clinical self-efficacy (p=0.04) and attitude toward team process (p=0.003). Students participating in the dedicated education unit model (p=0.016) and students participating in the blended model (pteam process among entry-level baccalaureate nursing students. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. Innovative measures to combat rare diseases in China: The national rare diseases registry system, larger-scale clinical cohort studies, and studies in combination with precision medicine research.

    Science.gov (United States)

    Song, Peipei; He, Jiangjiang; Li, Fen; Jin, Chunlin

    2017-02-01

    China is facing the great challenge of treating the world's largest rare disease population, an estimated 16 million patients with rare diseases. One effort offering promise has been a pilot national project that was launched in 2013 and that focused on 20 representative rare diseases. Another government-supported special research program on rare diseases - the "Rare Diseases Clinical Cohort Study" - was launched in December 2016. According to the plan for this research project, the unified National Rare Diseases Registry System of China will be established as of 2020, and a large-scale cohort study will be conducted from 2016 to 2020. The project plans to develop 109 technical standards, to establish and improve 2 national databases of rare diseases - a multi-center clinical database and a biological sample library, and to conduct studies on more than 50,000 registered cases of 50 different rare diseases. More importantly, this study will be combined with the concept of precision medicine. Chinese population-specific basic information on rare diseases, clinical information, and genomic information will be integrated to create a comprehensive predictive model with a follow-up database system and a model to evaluate prognosis. This will provide the evidence for accurate classification, diagnosis, treatment, and estimation of prognosis for rare diseases in China. Numerous challenges including data standardization, protecting patient privacy, big data processing, and interpretation of genetic information still need to be overcome, but research prospects offer great promise.

  16. The Definition of Pneumonia, the Assessment of Severity, and Clinical Standardization in the Pneumonia Etiology Research for Child Health Study

    Science.gov (United States)

    Wonodi, Chizoba; Moïsi, Jennifer C.; Deloria-Knoll, Maria; DeLuca, Andrea N.; Karron, Ruth A.; Bhat, Niranjan; Murdoch, David R.; Crawley, Jane; Levine, Orin S.; O’Brien, Katherine L.; Feikin, Daniel R.

    2012-01-01

    To develop a case definition for the Pneumonia Etiology Research for Child Health (PERCH) project, we sought a widely acceptable classification that was linked to existing pneumonia research and focused on very severe cases. We began with the World Health Organization’s classification of severe/very severe pneumonia and refined it through literature reviews and a 2-stage process of expert consultation. PERCH will study hospitalized children, aged 1–59 months, with pneumonia who present with cough or difficulty breathing and have either severe pneumonia (lower chest wall indrawing) or very severe pneumonia (central cyanosis, difficulty breastfeeding/drinking, vomiting everything, convulsions, lethargy, unconsciousness, or head nodding). It will exclude patients with recent hospitalization and children with wheeze whose indrawing resolves after bronchodilator therapy. The PERCH investigators agreed upon standard interpretations of the symptoms and signs. These will be maintained by a clinical standardization monitor who conducts repeated instruction at each site and by recurrent local training and testing. PMID:22403224

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

    Science.gov (United States)

    Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi

    2017-01-01

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

  18. Role perceptions of nurse clinical research coordinators

    Directory of Open Access Journals (Sweden)

    Jones CT

    2013-09-01

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

  19. Public information about clinical trials and research.

    Science.gov (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

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

  20. Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

    DEFF Research Database (Denmark)

    Jones, Roy; Wilkinson, David; Lopez, Oscar L

    2011-01-01

    community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here...... a successful example of this type of collaboration in the field of dementia....

  1. The importance of Clinical Research

    Directory of Open Access Journals (Sweden)

    Frank Lizaraso Caparó

    2016-01-01

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

  2. Ethics in clinical research: the Indian perspective.

    Science.gov (United States)

    Sanmukhani, J; Tripathi, C B

    2011-03-01

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

  3. Action research methodology in clinical pharmacy

    DEFF Research Database (Denmark)

    Nørgaard, Lotte Stig; Sørensen, Ellen Westh

    2016-01-01

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

  4. Enhancing Comparative Effectiveness Research With Automated Pediatric Pneumonia Detection in a Multi-Institutional Clinical Repository: A PHIS+ Pilot Study.

    Science.gov (United States)

    Meystre, Stephane; Gouripeddi, Ramkiran; Tieder, Joel; Simmons, Jeffrey; Srivastava, Rajendu; Shah, Samir

    2017-05-15

    Community-acquired pneumonia is a leading cause of pediatric morbidity. Administrative data are often used to conduct comparative effectiveness research (CER) with sufficient sample sizes to enhance detection of important outcomes. However, such studies are prone to misclassification errors because of the variable accuracy of discharge diagnosis codes. The aim of this study was to develop an automated, scalable, and accurate method to determine the presence or absence of pneumonia in children using chest imaging reports. The multi-institutional PHIS+ clinical repository was developed to support pediatric CER by expanding an administrative database of children's hospitals with detailed clinical data. To develop a scalable approach to find patients with bacterial pneumonia more accurately, we developed a Natural Language Processing (NLP) application to extract relevant information from chest diagnostic imaging reports. Domain experts established a reference standard by manually annotating 282 reports to train and then test the NLP application. Findings of pleural effusion, pulmonary infiltrate, and pneumonia were automatically extracted from the reports and then used to automatically classify whether a report was consistent with bacterial pneumonia. Compared with the annotated diagnostic imaging reports reference standard, the most accurate implementation of machine learning algorithms in our NLP application allowed extracting relevant findings with a sensitivity of .939 and a positive predictive value of .925. It allowed classifying reports with a sensitivity of .71, a positive predictive value of .86, and a specificity of .962. When compared with each of the domain experts manually annotating these reports, the NLP application allowed for significantly higher sensitivity (.71 vs .527) and similar positive predictive value and specificity . NLP-based pneumonia information extraction of pediatric diagnostic imaging reports performed better than domain experts in this

  5. Case Study Research Methodology

    Directory of Open Access Journals (Sweden)

    Mark Widdowson

    2011-01-01

    Full Text Available Commenting on the lack of case studies published in modern psychotherapy publications, the author reviews the strengths of case study methodology and responds to common criticisms, before providing a summary of types of case studies including clinical, experimental and naturalistic. Suggestions are included for developing systematic case studies and brief descriptions are given of a range of research resources relating to outcome and process measures. Examples of a pragmatic case study design and a hermeneutic single-case efficacy design are given and the paper concludes with some ethical considerations and an exhortation to the TA community to engage more widely in case study research.

  6. Clinical Research Informatics Contributions from 2015.

    Science.gov (United States)

    Daniel, C; Choquet, R

    2016-11-10

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

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

    Science.gov (United States)

    Hatfield, Elizabeth; Dicks, Elizabeth; Parfrey, Patrick

    2009-01-01

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

  8. Be a Partner in Clinical Research

    Science.gov (United States)

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

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

    Science.gov (United States)

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

  10. Determinants of research use in clinical decision making among physical therapists providing services post-stroke: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Jaglal Susan B

    2010-10-01

    Full Text Available Abstract Background Despite evidence of the benefits of research use in post-acute stroke rehabilitation where compliance with clinical practice guidelines has been associated with functional recovery and patient satisfaction, the rate of reliance on the research literature in clinical decision making among physical therapists is low. More research examining factors that motivate physical therapists to consider research findings in neurological practice is needed to inform efforts to intervene. The objective of this study was to identify practitioner, organizational, and research characteristics associated with research use among physical therapists providing services post-stroke. Methods A cross-sectional mail survey of physical therapists providing services to people with stroke in Ontario, Canada was conducted. The survey questionnaire contained items to evaluate practitioner and organizational characteristics and perceptions of research considered to influence evidence-based practice (EBP, as well as the frequency of using research evidence in clinical decision making in a typical month. Ordinal regression was used to identify factors associated with research use. Results The percentage of respondents reporting research use in clinical decision making 0 to 1, 2 to 5, or 6+ times in a typical month was 33.8%, 52.9%, and 13.3%, respectively (n = 263. Academic preparation in the principles of EBP, research participation, service as a clinical instructor, self-efficacy to implement EBP, a positive attitude towards research, perceived organizational support of research use, and Internet access to bibliographic databases at work were each associated with research use and placed in the final regression model. In the final model (n = 244, academic preparation in EBP, EBP self-efficacy, agreement that research findings are useful, and research participation each remained significantly associated with research use after adjusting for the effects of

  11. Ethics in clinical research: The Indian perspective

    OpenAIRE

    J Sanmukhani; C B Tripathi

    2011-01-01

    Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organiza...

  12. Modern Clinical Research on LSD.

    Science.gov (United States)

    Liechti, Matthias E

    2017-10-01

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

  13. Clinical Psychology and Research: epistemological notes

    Directory of Open Access Journals (Sweden)

    Emanuela Coppola

    2013-05-01

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

  14. Barriers and opportunities for enhancing patient recruitment and retention in clinical research: findings from an interview study in an NHS academic health science centre.

    Science.gov (United States)

    Adams, Mary; Caffrey, Louise; McKevitt, Christopher

    2015-03-12

    In the UK, the recruitment of patients into clinical research is a national health research and development policy priority. There has been limited investigation of how national level factors operate as barriers or facilitators to recruitment work, particularly from the perspective of staff undertaking patient recruitment work. The aim of this study is to identify and examine staff views of the key organisational barriers and facilitators to patient recruitment work in one clinical research group located in an NHS Academic Health Science Centre. A qualitative study utilizing in-depth, one-to-one semi-structured interviews with 11 purposively selected staff with particular responsibilities to recruit and retain patients as clinical research subjects. Thematic analysis classified interview data by recurring themes, concepts, and emergent categories for the purposes of establishing explanatory accounts. The findings highlight four key factors that staff perceived to be most significant for the successful recruitment and retention of patients in research and identify how staff located these factors within patients, studies, the research centre, the trust, and beyond the trust. Firstly, competition for research participants at an organisational and national level was perceived to undermine recruitment success. Secondly, the tension between clinical and clinical research workloads was seen to interrupt patient recruitment into studies, despite national funding arrangements to manage excess treatment costs. Thirdly, staff perceived an imbalance between personal patient burden and benefit. Ethical committee regulation, designed to protect patients, was perceived by some staff to detract from clarification and systematisation of incentivisation strategies. Finally, the structure and relationships within clinical research teams, in particular the low tacit status of recruitment skills, was seen as influential. The results of this case-study, conducted in an exemplary NHS

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

    Science.gov (United States)

    Fujii, Hisako

    2017-07-01

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

  16. The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2015-06-01

    To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. Percutaneous nephrolithotomy among patients with renal anomalies: patient characteristics and outcomes; a subgroup analysis of the clinical research office of the endourological society global percutaneous nephrolithotomy study

    NARCIS (Netherlands)

    Osther, Palle Jörn; Razvi, Hassan; Liatsikos, Evangelos; Averch, Timothy; Crisci, Alfonso; Garcia, Juan Lòpez; Mandal, Arup; de la Rosette, Jean

    2011-01-01

    This study compared the characteristics and outcomes of percutaneous nephrolithotomy (PCNL) in patients with and without renal malformations using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database. The CROES PCNL Global Study collected prospective data for

  18. Recruitment and Retention Strategies for Minority or Poor Clinical Research Participants: Lessons from the Healthy Aging in Neighborhoods of Diversity across the Life Span Study

    Science.gov (United States)

    Ejiogu, Ngozi; Norbeck, Jennifer H.; Mason, Marc A.; Cromwell, Bridget C.; Zonderman, Alan B.; Evans, Michele K.

    2011-01-01

    Purpose of the study: Investigating health disparities requires studies designed to recruit and retain racially and socioeconomically diverse cohorts. It is critical to address the barriers that disproportionately affect participation in clinical research by minorities and the socioeconomically disadvantaged. This study sought to identify and…

  19. Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs is yet unclear.To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval.We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why.Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs. NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14% versus 78/288 (27%, p<0.001, missing data excluded. Poor recruitment was the most frequent reason for discontinuation in both NPSs (36% and RCTs (37%.Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs.

  20. Anxiety, Depression, and Adverse Clinical Outcomes in Patients With Atrial Fibrillation Starting Warfarin: Cardiovascular Research Network WAVE Study.

    Science.gov (United States)

    Baumgartner, Christine; Fan, Dongjie; Fang, Margaret C; Singer, Daniel E; Witt, Daniel M; Schmelzer, John R; Williams, Marc S; Gurwitz, Jerry H; Sung, Sue Hee; Go, Alan S

    2018-04-14

    Anxiety and depression are associated with worse outcomes in several cardiovascular conditions, but it is unclear whether they affect outcomes in atrial fibrillation (AF). In a large diverse population of adults with AF, we evaluated the association of diagnosed anxiety and/or depression with stroke and bleeding outcomes. The Cardiovascular Research Network WAVE (Community-Based Control and Persistence of Warfarin Therapy and Associated Rates and Predictors of Adverse Clinical Events in Atrial Fibrillation and Venous Thromboembolism) Study included adults with AF newly starting warfarin between 2004 and 2007 within 5 health delivery systems in the United States. Diagnosed anxiety and depression and other patient characteristics were identified from electronic health records. We identified stroke and bleeding outcomes from hospitalization databases using validated International Classification of Diseases, Ninth Revision ( ICD-9 ), codes. We used multivariable Cox regression to assess the relation between anxiety and/or depression with outcomes after adjustment for stroke and bleeding risk factors. In 25 570 adults with AF initiating warfarin, 490 had an ischemic stroke or intracranial hemorrhage (1.52 events per 100 person-years). In multivariable analyses, diagnosed anxiety was associated with a higher adjusted rate of combined ischemic stroke and intracranial hemorrhage (hazard ratio, 1.52; 95% confidence interval, 1.01-2.28). Results were not materially changed after additional adjustment for patient-level percentage of time in therapeutic anticoagulation range on warfarin (hazard ratio, 1.56; 95% confidence interval, 1.03-2.36). In contrast, neither isolated depression nor combined depression and anxiety were significantly associated with outcomes. Diagnosed anxiety was independently associated with increased risk of combined ischemic stroke and intracranial hemorrhage in adults with AF initiating warfarin that was not explained by differences in risk factors

  1. Bringing ayahuasca to the clinical research laboratory.

    Science.gov (United States)

    Riba, Jordi; Barbanoj, Manel J

    2005-06-01

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

  2. The changing landscape for clinical research.

    Science.gov (United States)

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

    1999-06-01

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

  3. The Clinical Research Center for Depression Study: Baseline Characteristics of a Korean Long-Term Hospital-Based Observational Collaborative Prospective Cohort Study

    Science.gov (United States)

    Kim, Tae-Suk; Jeong, Seung Hee; Kim, Jung-Bum; Lee, Min-Soo; Kim, Jae-Min; Yim, Hyeon-Woo

    2011-01-01

    Objective The Clinical Research Center for Depression (CRESCEND) study is a 9-year observational collaborative prospective cohort study for the clinical outcomes in participants with depressive disorders in Korea. In this study, we examined the baseline characteristics of the depressive participants as the hospital-based cohort. Methods Participants were assessed using various instruments including the Clinical Global Impression scale, 17-item Hamilton Depression Rating Scale (HDRS-17), Hamilton Anxiety Rating Scale, Brief Psychiatric Rating Scale, Social and Occupational Functioning Assessment Scale, Beck Depression Inventory-Second Edition, Scale for Suicide Ideation, and World Health Organization Quality of Life assessment instruments-abbreviated version. Also, personal histories of medical and psychiatric illnesses and the range of socio-epidemiologic and clinical data were collected from each participant. Results One thousand one hundred eighty three participants were recruited from 18 hospitals. The mean age of the participants was 47.9±15.9 year-old, 74.4% were female, 82.9% had been diagnosed of major depressive disorder, 40.9% were experiencing their first depressive episode, and 21.4% had a past history of suicide attempts. The majority (85.3%) of the participants were moderately to severely ill. The average HDRS-17 was 19.8±6.1. Significant gender differences at baseline were shown in age, education, marriage, employment, religion, and first depressive episode. Conclusion The baseline findings in the CRESCEND study showed some different characteristics of depression in Korea, suggesting a possibility of ethnic and cultural factors in depression. PMID:21519530

  4. Towards a More Competitive Italy in Clinical Research: The Survey of Attitudes towards Trial sites in Europe (The SAT-EU Study TM

    Directory of Open Access Journals (Sweden)

    Marta Gehring

    2014-11-01

    Full Text Available  BackgroundItaly is Europe’s third largest pharmaceutical market, yet it ranks only ninth in the number of NIH-registered clinical trials per capita. The aim of our study was to explore stakeholders’ perception of Italy as place to undertake clinical trials, and to estimate the potential economic impact of selected reforms in terms of incremental trial activity.MethodsThe Survey of Attitudes towards Trials in Europe (SAT-EU Study was an anonymous, web-based survey which systematically assessed factors impacting clinical trial site selection in Europe. Estimates of Italian economic impact were developed in collaboration with AICRO (Association of Italian Contract Research Organisations.ResultsResponses were obtained from 485 professionals in 34 countries (15% residing in Italy representing over 100 institutions, spanning BioPharma Clinical Research Organizations (CROs, and Academic Clinical Trial Units (CTUs. Italy ranked tenth of twelve in terms of accessibility and transparency of information required to run clinical trials, and last with respect to predictability and speed of Ethics Committees. Costs of running clinical trials were not considered critical, whereas, fragmented and slow approval process was. Streamlined centralized trial authorization would translate into an estimated 1.1 billion Euros of incremental trial investments over three years. ConclusionsClinical trial professionals consider Italy’s governance of clinical research suboptimal, among the worst in Europe, and indicate that much could be done to make Italy more attractive for clinical trial investments. The present study also provides evidence about stakeholders’ willingness to invest in trials and its economic consequences provided effective reforms are put in place. 

  5. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

    Science.gov (United States)

    Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

    2010-10-01

    In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

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

    Science.gov (United States)

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

    2015-01-01

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

  7. Infectious Disease Clinical Research Program (IDCRP)

    Data.gov (United States)

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

  8. Clinical Research Strategies for Fructose Metabolism12

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

    Ishizaki, Junko

    2017-01-01

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

  10. Using connected objects in clinical research.

    Science.gov (United States)

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

    2018-02-01

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

  11. Women's perceptions of polycystic ovary syndrome following participation in a clinical research study: implications for knowledge, feelings, and daily health practices.

    Science.gov (United States)

    Colwell, Katie; Lujan, Marla E; Lawson, Karen L; Pierson, Roger A; Chizen, Donna R

    2010-05-01

    Polycystic ovary syndrome (PCOS) is a complex endocrine disorder that affects 6% to 10% of reproductive aged women. It is a poorly understood and often undiagnosed condition that has implications for the health of affected women. We assessed changes in knowledge, feelings, and daily health practices related to PCOS in clinical research study participants. Sixty-eight women who had received counselling and education about PCOS while participating in a clinical research study were invited to complete an online survey that assessed levels of concern, knowledge, healthy dieting, active living, and health care satisfaction before and after the study. Differences and associations between scores were analyzed by paired t tests and Pearson correlation. Forty-three women (63%) completed the survey. After taking part in a clinical research study, participants believed they had increased knowledge of (P better lifestyle practices (P women felt empowered to participate in the management of their condition and communicate with their primary care providers. Women with PCOS felt that they had more knowledge and motivation to implement preventive health strategies after participating in a clinical research study. Education about how PCOS affects their immediate and long-term health enabled women with PCOS to feel physical and psychological benefits and to engage more with their health care providers.

  12. Early results from a multi-component French public-private partnership initiative to improve participation in clinical research - CeNGEPS: a prospective before-after study.

    Science.gov (United States)

    Bordet, Régis; Lang, Marie; Dieu, Christelle; Billon, Nathalie; Duffet, Jean-Pierre

    2015-08-19

    A public-private (51/49 %) partnership was initiated in 2007 in France to improve the attractiveness of French sites in industry-sponsored international clinical trials. This initiative developed and implemented a combination of structuring actions and support actions. Here we report the assessment of the impact after 6 years on participation of French study sites in industry-sponsored clinical trials. We performed a prospective before-after study of clinical research activities in French public hospitals to assess the impact of actions developed and implemented by CeNGEPS. The programme involved a combination of structuring actions (establishment of sites of excellence, national networks and dedicated clinical research assistants (CRAs)), support actions (tools, templates and training) and competitive budget allocation for sites or networks based on performance. The impact was assessed using the following performance criteria: 1) reduction of the delay to contract signature to ≤ 60 days for 80 % of the trial sites; 2) inclusion of ≥80 % of the planned number of patients by at least 80 % of trial sites; 3) closure of attractiveness for industry-sponsored clinical research. The two main actions, i.e. establishing sites of excellence throughout the country with well-trained, dedicated staff and establishing a national network of clinical investigators, could be adapted to other countries in Western Europe to improve Europe's attractiveness to industry-funded trials.

  13. Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology.

    Science.gov (United States)

    Tonetti, Maurizio; Palmer, Richard

    2012-02-01

    The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome

  14. Talking to the people that really matter about their participation in pandemic clinical research: A qualitative study in four European countries.

    Science.gov (United States)

    Gobat, Nina H; Gal, Micaela; Butler, Christopher C; Webb, Steve A R; Francis, Nicholas A; Stanton, Helen; Anthierens, Sibyl; Bastiaens, Hilde; Godycki-Ćwirko, Maciek; Kowalczyk, Anna; Pons-Vigués, Mariona; Pujol-Ribera, Enriqueta; Berenguera, Anna; Watkins, Angela; Sukumar, Prasanth; Moore, Ronald G; Hood, Kerenza; Nichol, Alistair

    2018-02-01

    Pandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza-like illness pandemic. Descriptive-interpretive qualitative study, using focus groups (n = 10) and semi-structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK. Local qualitative researchers followed a scenario-based topic guide to collect data. Data were transcribed verbatim, translated into English and subject to framework analysis. Public understandings of pandemics were shaped by personal factors (illness during the previous H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information). Informants appreciated safeguards provided by ethically robust research procedures, but current enrolment procedures were seen as a barrier. They proposed simplified enrolment processes for higher risk research and consent waiver for certain types of low-risk research. Decision making about research participation was influenced by contextual, research and personal factors. Informants generally either carefully weighed up various approaches to research participation or responded instinctively. They supported the principle of using routinely collected, anonymized clinical biological samples for research without explicit consent, but regarded this as less acceptable if researchers were motivated primarily by commercial gain. This bottom-up approach to ascertaining public views on pandemic clinical research has identified support for more proportionate research protection procedures for publically funded, low-risk studies. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  15. Does age at onset of first major depressive episode indicate the subtype of major depressive disorder?: the clinical research center for depression study.

    Science.gov (United States)

    Park, Seon-Cheol; Hahn, Sang-Woo; Hwang, Tae-Yeon; Kim, Jae-Min; Jun, Tae-Youn; Lee, Min-Soo; Kim, Jung-Bum; Yim, Hyeon-Woo; Park, Yong Chon

    2014-11-01

    The purpose of this study was to evaluate the effects of age at onset of the first major depressive episode on the clinical features of individuals with major depressive disorder (MDD) in a large cohort of Korean depressed patients. We recruited 419 MDD patients of age over 18 years from the Clinical Research Center for Depression study in South Korea. At the start of the study, the onset age of the first major depressive episode was self-reported by the subjects. The subjects were divided into four age-at-onset subgroups: childhood and adolescent onset (ages depressive episodes (F=3.475, p=0.016) and higher scores on the brief psychiatric rating scale (F=3.254, p=0.022), its negative symptom subscale (F=6.082, pdepressive episode is a promising clinical indicator for the clinical presentation, course, and outcome of MDD.

  16. Chloracne: From clinic to research

    Directory of Open Access Journals (Sweden)

    Qiang Ju

    2012-03-01

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

  17. Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies : Challenges and opportunities

    NARCIS (Netherlands)

    van Leeuwen, M.L.; Efficace, F.; Fosså, S.D.; Bolla, M.; de Giorgi, U.; De Wit, R.; Holzner, B.; van de Poll-Franse, L.; White, J.; Collette, L.; Osanto, S.; Aaronson, N.K.; European Organisation for Research and Treatment of Cancer Quality of Life Group; Genito-Urinary Cancers Group, The

    2014-01-01

    Objectives In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting

  18. Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies: Challenges and opportunities

    NARCIS (Netherlands)

    van Leeuwen, M.; Efficace, F.; Fosså, S.D.; Bolla, M.; De Giorgi, U.; de Wit, R; Holzner, B.; van de Poll-Franse, L.V.; van Poppel, H.; White, J.; Collette, L.; Osanto, S.; Aaronson, N.K.

    2014-01-01

    Objectives: In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting

  19. Antiphospholipid Syndrome Clinical Research Task Force Report

    NARCIS (Netherlands)

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

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

  20. Blockchain technology for improving clinical research quality

    OpenAIRE

    Benchoufi, Mehdi; Ravaud, Philippe

    2017-01-01

    Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research. A new technology, Blockchain, may be a key to addressing these challenges and should draw the attention of the whole clinical research community. Blockchain brings the Internet to its definitive decentralisation goal. The core principle of Blockchain is that any service relying on trusted third parties can be built in a transpar...

  1. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

    Science.gov (United States)

    Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

    2011-12-01

    New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

  2. Leveraging electronic health records for clinical research.

    Science.gov (United States)

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

    2018-04-30

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

  3. Cleveland Clinic Rehabilitation Research Program

    Science.gov (United States)

    2015-12-01

    Study 1: The penicillin-induced seizure animal model has been generated by acute focal intracortical injection of penicillin in the motor cortex of rats ... motor cortex of rats . The effects of transcranial magnetic stimulation (TMS) on penicillin-induced seizure have been investigated using behavioral...electroencephalographic (EEG) recording. Study 2: The motor cortex (M1) and the corticospinal tracts (CST) will be directly modulated using brain stimulation

  4. [Alfredo Lanari, a clinical research style].

    Science.gov (United States)

    Romero, Lucía

    2012-01-01

    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.

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

    Science.gov (United States)

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

    2015-06-01

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

  6. Clinic research on the treatment for humeral shaft fracture with minimal invasive plate osteosynthesis: a retrospective study of 128 cases.

    Science.gov (United States)

    Chen, H; Hu, X; Yang, G; Xiang, M

    2017-04-01

    Minimal invasive plate osteosynthesis (MIPO) is one of the most important techniques in the treatment for humeral shaft fractures. This study was performed to evaluate the efficacy of MIPO technique for the treatment for humeral shaft fractures. We retrospectively evaluated 128 cases with humeral shaft fractures that were treated with MIPO technique from March 2005 to August 2008. All the patients were followed up by routine radiological imaging and clinical examinations. Constant-Murley score and HSS elbow joint score were used to evaluate the treatment outcome. The average duration of the surgery was 60 min (range 40-95 min) without blood transfusion. All fractures healed without infection. All cases recovered carrying angle except four cases with 10°-15° cubitus varus. After the average follow-up of 23 (13-38) months, satisfactory function was achieved according to Constant-Murley score and HSS elbow joint score. Constant-Murley score was 80 on average (range 68-91). According to HSS elbow joint score, there were 123 cases of excellent clinical outcome and five cases of effective outcome. It seems to be a safe and effective method for managing humeral shaft fractures with MIPO technique.

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

    Science.gov (United States)

    Hadi, Muhammad Abdul; José Closs, S

    2016-06-01

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

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

    Science.gov (United States)

    Siedlecki, Sandra L; Albert, Nancy M

    2017-03-01

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

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

    Science.gov (United States)

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

    2014-08-01

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

  10. Prolactinomas : clinical studies

    NARCIS (Netherlands)

    Kars, Marleen

    2008-01-01

    Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

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

    Science.gov (United States)

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

    2015-06-01

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

  12. Altruism in clinical research: coordinators' orientation to their professional roles.

    Science.gov (United States)

    Fisher, Jill A; Kalbaugh, Corey A

    2012-01-01

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

  13. The research questions and methodological adequacy of clinical studies of the voice and larynx published in Brazilian and international journals.

    Science.gov (United States)

    Vieira, Vanessa Pedrosa; De Biase, Noemi; Peccin, Maria Stella; Atallah, Alvaro Nagib

    2009-06-01

    To evaluate the methodological adequacy of voice and laryngeal study designs published in speech-language pathology and otorhinolaryngology journals indexed for the ISI Web of Knowledge (ISI Web) and the MEDLINE database. A cross-sectional study conducted at the Universidade Federal de São Paulo (Federal University of São Paulo). Two Brazilian speech-language pathology and otorhinolaryngology journals (Pró-Fono and Revista Brasileira de Otorrinolaringologia) and two international speech-language pathology and otorhinolaryngology journals (Journal of Voice, Laryngoscope), all dated between 2000 and 2004, were hand-searched by specialists. Subsequently, voice and larynx publications were separated, and a speech-language pathologist and otorhinolaryngologist classified 374 articles from the four journals according to objective and study design. The predominant objective contained in the articles was that of primary diagnostic evaluation (27%), and the most frequent study design was case series (33.7%). A mere 7.8% of the studies were designed adequately with respect to the stated objectives. There was no statistical difference in the methodological quality of studies indexed for the ISI Web and the MEDLINE database. The studies published in both national journals, indexed for the MEDLINE database, and international journals, indexed for the ISI Web, demonstrate weak methodology, with research poorly designed to meet the proposed objectives. There is much scientific work to be done in order to decrease uncertainty in the field analysed.

  14. Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team.

    Science.gov (United States)

    Ho, M W; Pick, A S; Sutton, D N; Dyker, K; Cardale, K; Gilbert, K; Johnson, J; Quantrill, J; McCaul, J A

    2018-05-01

    We reviewed longitudinal recruitment data to assess recruitment into head and neck cancer trials, and to identify factors that could influence this and affect their acceptability to patients. We retrieved data from the prospective computerised database (2009-2016) to measure acceptability to patients using the recruitment:screening ratio, and compared observational with interventional studies, single specialty (or site) with multispecialty (or site) studies, and "step-up" randomisation with "non-inferiority" randomisation designs. A total of 1283 patients were screened and 583 recruited. The recruitment:screening ratio for all National Institute for Health Research (NIHR) portfolio studies combined was 0.47 (486/1133). Studies that involved treatment by several specialties or at several sites had a significantly adverse impact on acceptability (p=0.01). Recruitment into non-inferiority randomised controlled studies was lower than that into step-up randomised studies (p=0.06). The complexity of a study's design did not compromise recruitment. Treatment across several specialties or several sites and perceived non-inferiority designs, reduced the acceptability of some trials. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

  15. CLARA: an integrated clinical research administration system

    Science.gov (United States)

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

    2014-01-01

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

  16. Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

    Science.gov (United States)

    Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

    2017-02-01

    This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

  17. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study.

    Directory of Open Access Journals (Sweden)

    Andrew Schumacher

    Full Text Available Informed consent forms (ICFs for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies.We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics.Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials were significantly longer (P < .0001 and had lower Flesch ease-of-reading scores (P = .003 than investigator-initiated trials (N = 11. At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011. The scores did not differ significantly by type of cancer therapy (P = .12 or trial sponsor (P = .38.Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient's education level or cultural characteristics should be evaluated across socio-demographic groups.Clinicaltrials.gov NCT01772511.

  18. Menstrual questionnaires for clinical and research use.

    Science.gov (United States)

    Matteson, Kristen A

    2017-04-01

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

  19. Radiopharmacy - clinical reality and selected research demands

    International Nuclear Information System (INIS)

    Hoer, G.

    2001-01-01

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

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

    Science.gov (United States)

    Smith, Kirsten V; Thew, Graham R

    2017-09-01

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

  1. Converging clinical and engineering research on neurorehabilitation

    CERN Document Server

    Torricelli, Diego; Pajaro, Marta

    2013-01-01

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

  2. Case study in designing a research fundamentals curriculum for community health workers: a university-community clinic collaboration.

    Science.gov (United States)

    Dumbauld, Jill; Kalichman, Michael; Bell, Yvonne; Dagnino, Cynthia; Taras, Howard L

    2014-01-01

    Community health workers (CHWs) are increasingly incorporated into research teams. Training them in research methodology and ethics, while relating these themes to a community's characteristics, may help to better integrate these health promotion personnel into research teams. An interactive training course on research fundamentals for CHWs was designed and implemented jointly by a community agency serving a primarily Latino, rural population and an academic health center. A focus group of community members and input from community leaders comprised a community-based participatory research model to create three 3-hour interactive training sessions. The resulting curriculum was interactive and successfully stimulated dialogue between trainees and academic researchers. By choosing course activities that elicited community-specific responses into each session's discussion, researchers learned about the community as much as the training course educated CHWs about research. The approach is readily adaptable, making it useful to other communities where CHWs are part of the health system.

  3. Clinical trials: bringing research to the bedside.

    Science.gov (United States)

    Arvay, C A

    1991-02-01

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

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

    DEFF Research Database (Denmark)

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

    2009-01-01

    in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching...... with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification...

  5. Learning Study as a Clinical Research Practice to Generate Knowledge about the Learning of Historical Primary Source Analysis

    Science.gov (United States)

    Johansson, Patrik

    2017-01-01

    There is a demand for educational research that addresses questions found in teachers' practice. This line of research can be referred to as practitioner research, and it is motivated by the realisation that teacher professionalism is one of the most influential factors in determining student achievement. One question is whether the primary…

  6. Clinical Research Nursing: A Critical Resource in the National Research Enterprise

    Science.gov (United States)

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

    2012-01-01

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

  7. Research Issues in Clinical Data Warehousing

    DEFF Research Database (Denmark)

    Pedersen, Torben Bach; Jensen, Christian Søndergaard

    1998-01-01

    to data warehousing technologies, over those posed by conventional data warehouse applications. This article presents a number of exciting new research challenges posed by clinical applications, to be met by the database research community. These include the need for complex-data modeling features...

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

    Science.gov (United States)

    Kotecki, Nuria; Penel, Nicolas; Awada, Ahmad

    2017-09-01

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

  9. [Conflict of interests in clinical research].

    Science.gov (United States)

    Alves, Elaine Maria de Oliveira; Tubino, Paulo

    2007-01-01

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

  10. Transitioning from Clinical to Qualitative Research Interviewing

    Directory of Open Access Journals (Sweden)

    Matthew R. Hunt BSc (PT, PhD

    2011-09-01

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

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

    Science.gov (United States)

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

    2011-01-01

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

  12. The definition of pneumonia, the assessment of severity, and clinical standardization in the Pneumonia Etiology Research for Child Health study

    NARCIS (Netherlands)

    Scott, J. Anthony G.; Wonodi, Chizoba; Moïsi, Jennifer C.; Deloria-Knoll, Maria; DeLuca, Andrea N.; Karron, Ruth A.; Bhat, Niranjan; Murdoch, David R.; Crawley, Jane; Levine, Orin S.; O'Brien, Katherine L.; Feikin, Daniel R.; Black, Robert E.; Bhutta, Zulfiqar A.; Campbell, Harry; Cherian, Thomas; Crook, Derrick W.; de Jong, Menno D.; Dowell, Scott F.; Graham, Stephen M.; Klugman, Keith P.; Lanata, Claudio F.; Madhi, Shabir A.; Martin, Paul; Nataro, James P.; Piazza, Franco M.; Qazi, Shamim A.; Zar, Heather J.

    2012-01-01

    To develop a case definition for the Pneumonia Etiology Research for Child Health (PERCH) project, we sought a widely acceptable classification that was linked to existing pneumonia research and focused on very severe cases. We began with the World Health Organization's classification of severe/very

  13. Application of Standard Project Management Tools to Research--A Case Study from a Multi-National Clinical Trial

    Science.gov (United States)

    Gist, Peter; Langley, David

    2007-01-01

    PRINCE2, which stands for Projects in Controlled Environments, is a project management method covering the organisation, management, and control of projects and is widely used in both government and commercial IT and building projects in the UK. This paper describes the application of PRINCE2 to the management of large clinical trials…

  14. Towards evidence-based computational statistics: lessons from clinical research on the role and design of real-data benchmark studies.

    Science.gov (United States)

    Boulesteix, Anne-Laure; Wilson, Rory; Hapfelmeier, Alexander

    2017-09-09

    The goal of medical research is to develop interventions that are in some sense superior, with respect to patient outcome, to interventions currently in use. Similarly, the goal of research in methodological computational statistics is to develop data analysis tools that are themselves superior to the existing tools. The methodology of the evaluation of medical interventions continues to be discussed extensively in the literature and it is now well accepted that medicine should be at least partly "evidence-based". Although we statisticians are convinced of the importance of unbiased, well-thought-out study designs and evidence-based approaches in the context of clinical research, we tend to ignore these principles when designing our own studies for evaluating statistical methods in the context of our methodological research. In this paper, we draw an analogy between clinical trials and real-data-based benchmarking experiments in methodological statistical science, with datasets playing the role of patients and methods playing the role of medical interventions. Through this analogy, we suggest directions for improvement in the design and interpretation of studies which use real data to evaluate statistical methods, in particular with respect to dataset inclusion criteria and the reduction of various forms of bias. More generally, we discuss the concept of "evidence-based" statistical research, its limitations and its impact on the design and interpretation of real-data-based benchmark experiments. We suggest that benchmark studies-a method of assessment of statistical methods using real-world datasets-might benefit from adopting (some) concepts from evidence-based medicine towards the goal of more evidence-based statistical research.

  15. A model (CMBP) for collaboration between university college and nursing practice to promote research utilization in students' clinical placements: a pilot study.

    Science.gov (United States)

    Elsborg Foss, Jette; Kvigne, Kari; Wilde Larsson, Bodil; Athlin, Elsy

    2014-08-01

    A collaborative project was initiated in Norway between a university college and a hospital in order to improve RNs' and nursing students' research utilization in clinical placements. This paper describes the model (CMBP) that was developed, its first application, and evaluation. The evaluation aimed at describing nurses' and students' experiences of the CMBP related to collaboration, facilitation, learning, and impact on nursing care. Thirty-eight students from the second and third year of nursing education, and four nurses answered questionnaires with closed and open ended questions. In addition two of the nurses wrote diaries. Data were subjected to qualitative and quantitative analysis. Almost all participants reported that collaboration between nursing college and nursing practice had been beneficial. Most students and all nurses reported about valuable learning, increased understanding of research utilization, and improved quality of nursing care. Both students and RNs recommended the CMBP to be used in all clinical placements to support academic learning and increase research utilization in clinical practice. Despite study limitations the findings indicate that the CMBP has a potential to be a useful model for teaching RNs' and students EBP. However, further refinement of the model is needed, followed by a more comprehensive implementation and evaluation. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. Electronic health records to facilitate clinical research

    OpenAIRE

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

    2016-01-01

    Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the pr...

  17. Towards evidence-based computational statistics: lessons from clinical research on the role and design of real-data benchmark studies

    Directory of Open Access Journals (Sweden)

    Anne-Laure Boulesteix

    2017-09-01

    Full Text Available Abstract Background The goal of medical research is to develop interventions that are in some sense superior, with respect to patient outcome, to interventions currently in use. Similarly, the goal of research in methodological computational statistics is to develop data analysis tools that are themselves superior to the existing tools. The methodology of the evaluation of medical interventions continues to be discussed extensively in the literature and it is now well accepted that medicine should be at least partly “evidence-based”. Although we statisticians are convinced of the importance of unbiased, well-thought-out study designs and evidence-based approaches in the context of clinical research, we tend to ignore these principles when designing our own studies for evaluating statistical methods in the context of our methodological research. Main message In this paper, we draw an analogy between clinical trials and real-data-based benchmarking experiments in methodological statistical science, with datasets playing the role of patients and methods playing the role of medical interventions. Through this analogy, we suggest directions for improvement in the design and interpretation of studies which use real data to evaluate statistical methods, in particular with respect to dataset inclusion criteria and the reduction of various forms of bias. More generally, we discuss the concept of “evidence-based” statistical research, its limitations and its impact on the design and interpretation of real-data-based benchmark experiments. Conclusion We suggest that benchmark studies—a method of assessment of statistical methods using real-world datasets—might benefit from adopting (some concepts from evidence-based medicine towards the goal of more evidence-based statistical research.

  18. BALANOPOSTHITIS: A CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Raju

    2015-01-01

    Full Text Available INTRODUCTION: The inflammation of the non - keratinized epithelium of the glans penis (i.e., Balanities and that of prepuce (i.e., posthitis together comprise the term Balanoposthitis. AIMS AND OBJECTIVES: To determine the aetiological and p redisposing factors for the development of Balanoposthitis, and to know its relation with venereal and non - venereal disease, local and systemic precipitatin g factors. To know the prevalence of Balanoposthitis in STD clinic. Study design - retrospective study . MATERIALS AND METHODS: The study material consists of 75 cases of balanoposthitis attending out - patient department Skin & STD clinic during a period exten din g from Feb, 1998 to Feb, 1999 . CRITERIA FOR SELECTION OF A CASE: Only those cases which have a history of redness of glans or mucous surface of prepuce, with or without genital discharge or ulcer on glans or mucosal surface of prepuce with or without discharge or growth on the penis or fissuring of fore skin were selected for the study. RESULTS: Incidence of balanoposthitis during the period from Feb. 98 to Feb.99 was – 11.53%, out of 650 new STD cases. It was observed that maximum number of pat i ents w as in the 21 - 30 age group (33.34%. The next predominant groups affected were 17 - 20 & 31 - 40 age group (20% each. The third most common age group affected was 41 - 50 (16%. In this study 69 patients (92% who presented with balanoposthitis of whatever cause were found to be uncircumcised, only 6 cases (8% were found to be circumcised. Most cases who presented with balanoposthitis gave a history of exposure to STD risk. CONCLUSIONS: Balanoposthitis is very commonly encountered condition in the STD clinics wi th a multi factorial aetiology. Infective causes dominated over the other possible causes, and 30% of the candidial infection had diabetes mellitus as a predisposing factor.

  19. Heart Failure: From Research to Clinical Practice.

    Science.gov (United States)

    Islam, Md Shahidul

    2018-01-01

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

  20. Accounting for the sedative and analgesic effects of medication changes during patient participation in clinical research studies: measurement development and application to a sample of institutionalized geriatric patients.

    Science.gov (United States)

    Sloane, Philip; Ivey, Jena; Roth, Mary; Roederer, Mary; Williams, Christianna S

    2008-03-01

    To date, no system has been published that allows investigators to adjust for the overall sedative and/or analgesic effects of medications, or changes in medications, in clinical trial participants for whom medication use cannot be controlled. This is common in clinical trials of behavioral and complementary/alternative therapies, and in research involving elderly or chronically ill patients for whom ongoing medical care continues during the trial. This paper describes the development, and illustrates the use, of a method we developed to address this issue, in which we generate single continuous variables to represent the daily sedative and analgesic loads of multiple medications. Medications for 90 study participants in a clinical trial of a nonpharmacological intervention were abstracted from medication administration records across multiple treatment periods. An expert panel of three academic clinical pharmacists and a geriatrician met to develop a system by which each study medication could be assigned a sedative and analgesic effect rating. The two measures, when applied to data on 90 institutionalized persons with Alzheimer's disease, resulted in variables with moderately skewed distributions that are consistent with the clinical profile of analgesia and sedation use in long-term care populations. The average study participant received 1.89 analgesic medications per day and had a daily analgesic load of 2.96; the corresponding figures for sedation were 2.07 daily medications and an average daily load of 11.41. A system of classifying the sedative and analgesic effects of non-study medications was created that divides drugs into categories based on the strength of their effects and assigns a rating to express overall sedative and analgesic effects. These variables may be useful in comparing patients and populations, and to control for drug effects in future studies.

  1. The use of reflective journaling as a learning strategy during the clinical rotations of students from the faculty of health sciences: An action-research study.

    Science.gov (United States)

    Ruiz-López, Montserrat; Rodriguez-García, Marta; Villanueva, Purificación-González; Márquez-Cava, Montserrat; García-Mateos, Mónica; Ruiz-Ruiz, Beatriz; Herrera-Sánchez, Esteban

    2015-10-01

    Reflective practice contributes significantly to the assimilation of knowledge in undergraduate health students. Reflective journals constitute a learning strategy that promotes student reflection during clinical practice. The overall aim of the study was to explore teachers' perceptions and experiences regarding the use of reflective clinical journals as a learning tool for students in order to improve the implementation of clinical journal writing in all the Health Science degrees offered by our University. A qualitative research study was performed using the Action-Research method. Students studying various degrees at our Health Faculty were considered for this study (Nursing Physiotherapy, and Physiotherapy and Physical Activity and Sport Science). Data were collected using triangulation of document analysis (102 student journals and 12 teacher journals, together with the teachers' responses to the student's journals) and transcripts from 2 discussion groups (1 student discussion group and 1 teacher discussion group). Data analysis was performed based on the constant comparative method using ATLAS.ti version 6.2 software. Four qualitative themes emerged from the data: the journal as a teaching strategy; building a relationship of trust between the tutor and the student; the role of the teacher and the world of emotions. Several recommendations for supporting clinical journal writing were identified: an informative meeting should be arranged with students; written guidelines should be provided; a personal interview with the student is recommended at the start of the activity; feedback should be offered over short time periods; teachers should provide constructive feedback; and students should adopt a free writing approach, or be guided by very open questions. Finally, it is important that students be familiarized with the assessment criteria. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. A systematic review assessing non-pharmacological conservative treatment studies for people with non-inflammatory multi-joint pain: clinical outcomes and research design considerations.

    Science.gov (United States)

    Comer, C; Smith, T O; Drew, B; Raja, R; Kingsbury, S R; Conaghan, Philip G

    2018-03-01

    To systematically review the evidence to determine the clinical outcomes and the important methodological quality features of interventional studies on adults with non-inflammatory multi-joint pain (MJP). Systematic search of published and unpublished literature using the databases: AMED, CINAHL, MEDLINE, EMBASE, psycINFO, SPORTDiscus, PEDro, OpenGrey, the EU Clinical Trials Register, World Health Organization International Clinical Trial Registry Platform, ClinicalTrials.gov and the ISRCTN registry (search: inception to 19th October 2017). All papers reporting the clinical outcomes of non-pharmacological interventions for people with non-inflammatory MJP were included. Studies were critically appraised using the Downs and Black Critical Appraisal and the TIDieR reporting checklists. Data were analysed using a Best Evidence Synthesis approach. From 3824 citations, four papers satisfied the eligibility criteria. Three studies reported outcomes from multidisciplinary rehabilitation programmes and one study reported the findings of a spa therapy intervention. All interventions significantly improved pain, function and quality of life in the short-term. There was limited reporting of measures for absenteeism, presenteeism and psychosocial outcomes. The evidence was 'weak', and due to a lack of controlled trials, there is limited evidence to ascertain treatment effectiveness. Design consideration for future trials surround improved reporting of participant characteristics, interventions and the standardisation of core outcome measures. There is insufficient high-quality trial data to determine the effectiveness of treatments for non-inflammatory MJP. Given the significant health burden which this condition presents on both individuals and wider society, developing and testing interventions and accurately reporting these, should be a research priority. Registration PROSPERO (CRD42013005888).

  3. Blockchain technology for improving clinical research quality.

    Science.gov (United States)

    Benchoufi, Mehdi; Ravaud, Philippe

    2017-07-19

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

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

    Science.gov (United States)

    Canham, Steve; Ohmann, Christian

    2016-11-24

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

  5. The Power of Flash Mob Research: Conducting a Nationwide Observational Clinical Study on Capillary Refill Time in a Single Day.

    Science.gov (United States)

    Alsma, Jelmer; van Saase, Jan L C M; Nanayakkara, Prabath W B; Schouten, W E M Ineke; Baten, Anique; Bauer, Martijn P; Holleman, Frits; Ligtenberg, Jack J M; Stassen, Patricia M; Kaasjager, Karin H A H; Haak, Harm R; Bosch, Frank H; Schuit, Stephanie C E

    2017-05-01

    Capillary refill time (CRT) is a clinical test used to evaluate the circulatory status of patients; various methods are available to assess CRT. Conventional clinical research often demands large numbers of patients, making it costly, labor-intensive, and time-consuming. We studied the interobserver agreement on CRT in a nationwide study by using a novel method of research called flash mob research (FMR). Physicians in the Netherlands were recruited by using word-of-mouth referrals, conventional media, and social media to participate in a nationwide, single-day, "nine-to-five," multicenter, cross-sectional, observational study to evaluate CRT. Patients aged ≥ 18 years presenting to the ED or who were hospitalized were eligible for inclusion. CRT was measured independently (by two investigators) at the patient's sternum and distal phalanx after application of pressure for 5 s (5s) and 15 s (15s). On October 29, 2014, a total of 458 investigators in 38 Dutch hospitals enrolled 1,734 patients. The mean CRT measured at the distal phalanx were 2.3 s (5s, SD 1.1) and 2.4 s (15s, SD 1.3). The mean CRT measured at the sternum was 2.6 s (5s, SD 1.1) and 2.7 s (15s, SD 1.1). Interobserver agreement was higher for the distal phalanx (κ value, 0.40) than for the sternum (κ value, 0.30). Interobserver agreement on CRT is, at best, moderate. CRT measured at the distal phalanx yielded higher interobserver agreement compared with sternal CRT measurements. FMR proved a valuable instrument to investigate a relatively simple clinical question in an inexpensive, quick, and reliable manner. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

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

    African Journals Online (AJOL)

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

  7. Random effects models in clinical research

    NARCIS (Netherlands)

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

    2008-01-01

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

  8. The social value of clinical research.

    Science.gov (United States)

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

    2014-09-05

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

  9. Reliability of routine clinical measurements of neonatal circumferences and research measurements of neonatal skinfold thicknesses: findings from the Born in Bradford study

    Science.gov (United States)

    West, Jane; Manchester, Ben; Wright, John; Lawlor, Debbie A; Waiblinger, Dagmar

    2011-01-01

    Summary West J, Manchester B, Wright J, Lawlor DA, Waiblinger D. Reliability of routine clinical measurements of neonatal circumferences and research measurements of neonatal skinfold thicknesses: findings from the Born in Bradford study. Paediatric and Perinatal Epidemiology 2011. Assessing neonatal size reliably is important for research and clinical practice. The aim of this study was to examine the reliability of routine clinical measurements of neonatal circumferences and of skinfold thicknesses assessed for research purposes. All measurements were undertaken on the same population of neonates born in a large maternity unit in Bradford, UK. Technical error of measurement (TEM), relative TEM and the coefficient of reliability are reported. Intra-observer TEMs for routine circumference measurements were all below 0.4 cm and were generally within ±2-times the mean. Inter-observer TEM ranged from 0.20 to 0.36 cm for head circumference, 0.19 to 0.39 cm for mid upper arm circumference and from 0.39 to 0.77 cm for abdominal circumference. Intra and inter-observer TEM for triceps skinfold thickness ranged from 0.22 to 0.35 mm and 0.15 to 0.54 mm, respectively. Subscapular skinfold thickness TEM values were 0.14 to 0.25 mm for intra-observer measurements and 0.17 to 0.63 mm for inter-observer measurements. Relative TEM values for routine circumferences were all below 4.00% but varied between 2.88% and 14.23% for research skinfold measurements. Reliability was mostly between 80% and 99% for routine circumference measurements and ≥70% for most research skinfold measurements. Routine clinical measurements of neonatal circumferences are reliably assessed in Bradford. Assessing skinfolds in neonates has variable reliability, but on the whole is good. The greater intra-observer, compared with inter-observer, reliability for both sets of measurements highlights the importance of having a minimal number of assessors whenever possible. PMID:21281329

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

    Science.gov (United States)

    2016-10-01

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

  11. 59th Clinical Research Division Research Day Briefing

    Science.gov (United States)

    2016-10-27

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

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

    Science.gov (United States)

    Ferrell, Courtney B.

    2009-01-01

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

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

    Science.gov (United States)

    Worthington, Catherine A; Gill, M John

    2008-08-01

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

  14. Clinical Research Careers: Reports from a NHLBI Pediatric Heart Network Clinical Research Skills Development Conference

    Science.gov (United States)

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

    2013-01-01

    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

  15. The clinical research office of the endourological society percutaneous nephrolithotomy global study: tract dilation comparisons in 5537 patients

    DEFF Research Database (Denmark)

    Lopes, Tomé; Sangam, Kandasami; Alken, Peter

    2011-01-01

    Abstract Purpose: The study focused on the use of balloon or telescopic/serial dilation methods in percutaneous nephrolithotomy (PCNL) in the Global PCNL Study. Patients and Methods: Centers worldwide provided data from consecutive patients who were treated with PCNL during a 1-year period. Tract...

  16. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: tract dilation comparisons in 5537 patients

    NARCIS (Netherlands)

    Lopes, Tomé; Sangam, Kandasami; Alken, Peter; Barroilhet, Benjamin Silva; Saussine, Christian; Shi, Lei; de la Rosette, Jean

    2011-01-01

    The study focused on the use of balloon or telescopic/serial dilation methods in percutaneous nephrolithotomy (PCNL) in the Global PCNL Study. Centers worldwide provided data from consecutive patients who were treated with PCNL during a 1-year period. Tract dilation was performed using a balloon or

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

    Science.gov (United States)

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

    2018-03-08

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

  18. Assessment of the feasibility and clinical value of further research to evaluate the management options for children with Down syndrome and otitis media with effusion: a feasibility study.

    Science.gov (United States)

    Fortnum, Heather; Leighton, Paul; Smith, Murray D; Brown, Lisa; Jones, Matthew; Benton, Claire; Marder, Elizabeth; Marshall, Andrew; Sutton, Kate

    2014-09-01

    There is clinical uncertainty of the benefits and costs of different treatment options for children with Down syndrome who have glue ear. This study was designed to assess the extent of this lack of knowledge and determine if pursuing further information would be practical, beneficial and cost-effective. To assess the level and practical effect of current uncertainty around treatment options for children with Down syndrome and glue ear. To assess the feasibility of studying the options for management of glue ear in children with Down syndrome via a randomised controlled trial (RCT) or multicentre prospective cohort study by evaluating the willingness of (1) parents to agree to randomisation for their children and (2) clinicians to recruit participants to a definitive study. To undertake value of information analyses to demonstrate the potential economic benefit from undertaking further research. A feasibility study exploring the views of parents of children with Down syndrome and professionals who have responsibility for the health and education of children with Down syndrome, on the participation in, and value of, future research into interventions for glue ear. Data were collected from parents via self-completed questionnaires, face-to-face interviews and focus groups and from professionals via online questionnaires and a Delphi review exercise. Development of economic models to represent clinical pathways of care and a RCT informed a value of information (VOI) analysis. UK (professionals); East Midlands region of the UK (parents). Parents of children aged 1-11 years with Down syndrome (n = 156). Professionals including audiologists, ear, nose and throat surgeons, audiological physicians, speech and language therapists, and teachers of the deaf (n = 128). Quantitative and qualitative data on parental views and experiences of glue ear and its effects; interventions and treatment received; taking part in research and factors that would encourage or

  19. adLIMS: a customized open source software that allows bridging clinical and basic molecular research studies.

    Science.gov (United States)

    Calabria, Andrea; Spinozzi, Giulio; Benedicenti, Fabrizio; Tenderini, Erika; Montini, Eugenio

    2015-01-01

    Many biological laboratories that deal with genomic samples are facing the problem of sample tracking, both for pure laboratory management and for efficiency. Our laboratory exploits PCR techniques and Next Generation Sequencing (NGS) methods to perform high-throughput integration site monitoring in different clinical trials and scientific projects. Because of the huge amount of samples that we process every year, which result in hundreds of millions of sequencing reads, we need to standardize data management and tracking systems, building up a scalable and flexible structure with web-based interfaces, which are usually called Laboratory Information Management System (LIMS). We started collecting end-users' requirements, composed of desired functionalities of the system and Graphical User Interfaces (GUI), and then we evaluated available tools that could address our requirements, spanning from pure LIMS to Content Management Systems (CMS) up to enterprise information systems. Our analysis identified ADempiere ERP, an open source Enterprise Resource Planning written in Java J2EE, as the best software that also natively implements some highly desirable technological advances, such as the high usability and modularity that grants high use-case flexibility and software scalability for custom solutions. We extended and customized ADempiere ERP to fulfil LIMS requirements and we developed adLIMS. It has been validated by our end-users verifying functionalities and GUIs through test cases for PCRs samples and pre-sequencing data and it is currently in use in our laboratories. adLIMS implements authorization and authentication policies, allowing multiple users management and roles definition that enables specific permissions, operations and data views to each user. For example, adLIMS allows creating sample sheets from stored data using available exporting operations. This simplicity and process standardization may avoid manual errors and information backtracking, features

  20. Current trends in research and clinical issues in the study of personality and its disorders: a survey of the presentations at the ISSPD anniversary congress.

    Science.gov (United States)

    Simonsen, Erik; Sørensen, Per; Pedersen, Liselotte

    2014-10-01

    The International Society for the Study of Personality Disorders (ISSPD) celebrated its 25th anniversary in September 2013 in Copenhagen and commemorated the First International Congress at the same site. The overall theme of the congress was "Bridging Personality and Psychopathology: The Person Behind the Illness." More than 400 abstracts were submitted, and the program included 8 keynote presentations, 18 invited symposia, a debate on current controversial issues in the classification of personality disorders (Fossati, Tyrer, Livesley, and Krueger), an ISSPD award lecture (Silk), a jubilee lecture (Simonsen), a young researchers' symposium (Hopwood, Sharp, and Kaess), and special lectures on the Danish philosopher Soeren Kierkegaard and the poet Hans Christian Andersen. In this article we will survey the presentations and highlight the important issues in order to underline the current trends in research and clinical interests in personality disorders. The keynote video presentations, invited symposia, and slide presentations are freely available at www.isspd2013.com.

  1. Knowledge Creation in Clinical Product Development Management Research

    DEFF Research Database (Denmark)

    Karlsson, Christer; Sköld, Martin

    2012-01-01

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

  2. Dimensional approach to symptom factors of major depressive disorder in Koreans, using the Brief Psychiatric Rating Scale: the Clinical Research Center for Depression of South Korea study.

    Science.gov (United States)

    Park, Seon-Cheol; Jang, Eun Young; Kim, Daeho; Jun, Tae-Youn; Lee, Min-Soo; Kim, Jae-Min; Kim, Jung-Bum; Jo, Sun-Jin; Park, Yong Chon

    2015-01-01

    Although major depressive disorder (MDD) has a variety of symptoms beyond the affective dimensions, the factor structure and contents of comprehensive psychiatric symptoms of this disorder have rarely been explored using the 18-item Brief Psychiatric Rating Scale (BPRS). We aimed to identify the factor structure of the 18-item BPRS in Korean MDD patients. A total of 258 MDD patients were recruited from a multicenter sample of the Clinical Research Center for Depression of South Korea study. Psychometric scales were used to assess overall psychiatric symptoms (BPRS), depression (Hamilton Depression Rating Scale), anxiety (Hamilton Anxiety Rating Scale), global severity (Clinical Global Impression of Severity Scale), suicidal ideation (Scale for Suicide Ideation), functioning (Social and Occupational Functioning Assessment Scale), and quality of life (World Health Organization Quality of Life Assessment-abbreviated version). Common factor analysis with oblique rotation was used to yield factor structure. A four-factor structure was designed and interpreted by the symptom dimensions to reflect mood disturbance, positive symptoms/apathy, bipolarity, and thought distortion/mannerism. These individual factors were also significantly correlated with clinical variables. The findings of this study support the view that the BPRS may be a promising measuring tool for the initial assessment of MDD patients. In addition, the four-factor structure of the BPRS may be useful in understanding the mood and psychotic characteristics of these patients. Copyright © 2014. Published by Elsevier Taiwan.

  3. Dimensional approach to symptom factors of major depressive disorder in Koreans, using the Brief Psychiatric Rating Scale: The Clinical Research Center for Depression of South Korea Study

    Directory of Open Access Journals (Sweden)

    Seon-Cheol Park

    2015-01-01

    Full Text Available Although major depressive disorder (MDD has a variety of symptoms beyond the affective dimensions, the factor structure and contents of comprehensive psychiatric symptoms of this disorder have rarely been explored using the 18-item Brief Psychiatric Rating Scale (BPRS. We aimed to identify the factor structure of the 18-item BPRS in Korean MDD patients. A total of 258 MDD patients were recruited from a multicenter sample of the Clinical Research Center for Depression of South Korea study. Psychometric scales were used to assess overall psychiatric symptoms (BPRS, depression (Hamilton Depression Rating Scale, anxiety (Hamilton Anxiety Rating Scale, global severity (Clinical Global Impression of Severity Scale, suicidal ideation (Scale for Suicide Ideation, functioning (Social and Occupational Functioning Assessment Scale, and quality of life (World Health Organization Quality of Life Assessment-abbreviated version. Common factor analysis with oblique rotation was used to yield factor structure. A four-factor structure was designed and interpreted by the symptom dimensions to reflect mood disturbance, positive symptoms/apathy, bipolarity, and thought distortion/mannerism. These individual factors were also significantly correlated with clinical variables. The findings of this study support the view that the BPRS may be a promising measuring tool for the initial assessment of MDD patients. In addition, the four-factor structure of the BPRS may be useful in understanding the mood and psychotic characteristics of these patients.

  4. A research mentor training curriculum for clinical and translational researchers.

    Science.gov (United States)

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

    2013-02-01

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

  5. Comparative audit of clinical research in pediatric neurology.

    Science.gov (United States)

    Al-Futaisi, Amna; Shevell, Michael

    2004-11-01

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

  6. Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies.

    Science.gov (United States)

    South, Annabelle; Hanley, Bec; Gafos, Mitzy; Cromarty, Ben; Stephens, Richard; Sturgeon, Kate; Scott, Karen; Cragg, William J; Tweed, Conor D; Teera, Jacqueline; Vale, Claire L

    2016-07-29

    Patient and public involvement (PPI) in studies carried out by the UK Medical Research Council Clinical Trials Unit (MRC CTU) at University College London varies by research type and setting. We developed a series of case studies of PPI to document and share good practice. We used purposive sampling to identify studies representing the scope of research at the MRC CTU and different approaches to PPI. We carried out semi-structured interviews with staff and patient representatives. Interview notes were analysed descriptively to categorise the main aims and motivations for involvement; activities undertaken; their impact on the studies and lessons learned. We conducted 19 interviews about ten case studies, comprising one systematic review, one observational study and 8 randomised controlled trials in HIV and cancer. Studies were either open or completed, with start dates between 2003 and 2011. Interviews took place between March and November 2014 and were updated in summer 2015 where there had been significant developments in the study (i.e. if the study had presented results subsequent to the interview taking place). A wide range of PPI models, including representation on trial committees or management groups, community engagement, one-off task-focused activities, patient research partners and participant involvement had been used. Overall, interviewees felt that PPI had a positive impact, leading to improvements, for example in the research question; study design; communication with potential participants; study recruitment; confidence to carry out or complete a study; interpretation and communication of results; and influence on future research. A range of models of PPI can benefit clinical studies. Researchers should consider different approaches to PPI, based on the desired impact and the people they want to involve. Use of multiple models may increase the potential impacts of PPI in clinical research.

  7. Current clinical research in orthodontics: a perspective.

    Science.gov (United States)

    Baumrind, Sheldon

    2006-10-01

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

  8. Periprosthetic Joint Infections: Clinical and Bench Research

    Directory of Open Access Journals (Sweden)

    Laurence Legout

    2013-01-01

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

  9. Danish research-active clinical nurses overcome barriers in research utilization.

    Science.gov (United States)

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

    2003-03-01

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

  10. ABDOMINAL TRAUMA- CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Vanaja Ratnakumari Billa

    2017-08-01

    Full Text Available BACKGROUND In the recent times there has been increased incidence of abdominal trauma cases due to several causes. Quick and prompt intervention is needed to decrease the mortality of the patients. So we conducted a study to assess the cause and the management of abdominal trauma cases in our institution. The aim of this study was to know the incidence of blunt and penetrating injuries and their causes, age and sex incidence, importance of various investigations, mode of treatment offered and post-operative complications. To study the cause of death and evolve better management. MATERIALS AND METHODS The present study comprises of patients admitted to and operated in various surgical units in the Department of Surgery at Government General Hospital, attached to Guntur Medical College Guntur, from August 2014 to October 2016. RESULTS Increase incidence seen in age group 20-29 years (30%. Male predominance 77.5%. Mechanism of injury–road traffic accidents 65%. Isolated organ injury–colon and rectum 40%. Other associated injuries–chest injuries with rib fractures 7.5%. Complications–wound infection 17.5%. Duration of hospital stay 8–14 days. Bowel injury management–closure of perforation 84.6%. Resection anastomosis 15.38%. CONCLUSION Thorough clinical examination, diagnostic paracentesis, plain X-ray erect abdomen and ultrasound proved to be very helpful in the diagnosis of intra-abdominal injuries. Spleen is the commonest organ involved in blunt trauma and colon is the commonly injured organ in penetrating abdominal trauma, many patients have associated extremity and axial skeleton injuries. With advances in diagnosis and intensive care technologies, most patients of solid visceral injuries with hemodynamic stability can be managed conservatively. Surgical site infection is the most common complication following surgery. The mortality is high; reason might be patient reaching the hospital late, high incidence of postoperative septic

  11. Negotiation skills for clinical research professionals

    Directory of Open Access Journals (Sweden)

    Sanjay Hake

    2011-01-01

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

  12. Negotiation skills for clinical research professionals

    Science.gov (United States)

    Hake, Sanjay; Shah, Tapankumar

    2011-01-01

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

  13. Age-related prevalence of diabetes mellitus, cardiovascular disease and anticoagulation therapy use in a urolithiasis population and their effect on outcomes: the Clinical Research Office of the Endourological Society Ureteroscopy Global Study

    NARCIS (Netherlands)

    Daels, F. Pedro J.; Gaizauskas, Andrius; Rioja, Jorge; Varshney, Anil K.; Erkan, Erkan; Ozgok, Yasar; Melekos, Michael; de La Rosette, Jean J. M. C. H.

    2015-01-01

    This study examined the prevalence of risk factors for urological stone surgery and their possible influence on outcome and complications following ureteroscopy (URS). The Clinical Research Office of the Endourological Society Ureteroscopy Global Study collected prospective data on consecutive

  14. Feasibility of Conducting Autism Biomarker Research in the Clinical Setting.

    Science.gov (United States)

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

    2017-09-01

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

  15. Reaching beyond the review of research evidence: a qualitative study of decision making during the development of clinical practice guidelines for disease prevention in healthcare.

    Science.gov (United States)

    Richter Sundberg, Linda; Garvare, Rickard; Nyström, Monica Elisabeth

    2017-05-11

    The judgment and decision making process during guideline development is central for producing high-quality clinical practice guidelines, but the topic is relatively underexplored in the guideline research literature. We have studied the development process of national guidelines with a disease-prevention scope produced by the National board of Health and Welfare (NBHW) in Sweden. The NBHW formal guideline development model states that guideline recommendations should be based on five decision-criteria: research evidence; curative/preventive effect size, severity of the condition; cost-effectiveness; and ethical considerations. A group of health profession representatives (i.e. a prioritization group) was assigned the task of ranking condition-intervention pairs for guideline recommendations, taking into consideration the multiple decision criteria. The aim of this study was to investigate the decision making process during the two-year development of national guidelines for methods of preventing disease. A qualitative inductive longitudinal case study approach was used to investigate the decision making process. Questionnaires, non-participant observations of nine two-day group meetings, and documents provided data for the analysis. Conventional and summative qualitative content analysis was used to analyse data. The guideline development model was modified ad-hoc as the group encountered three main types of dilemmas: high quality evidence vs. low adoptability of recommendation; insufficient evidence vs. high urgency to act; and incoherence in assessment and prioritization within and between four different lifestyle areas. The formal guideline development model guided the decision-criteria used, but three new or revised criteria were added by the group: 'clinical knowledge and experience', 'potential guideline consequences' and 'needs of vulnerable groups'. The frequency of the use of various criteria in discussions varied over time. Gender, professional status

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

    Science.gov (United States)

    Weng, C; Kahn, M G

    2016-11-10

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

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

    Science.gov (United States)

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

  18. [Clinical research XXIV. From clinical judgment to ethics in research on humans].

    Science.gov (United States)

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

    2014-01-01

    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.

  19. The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial

    Science.gov (United States)

    Thow, Megan; Ferguson, Stuart G

    2016-01-01

    Background Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-reach populations), cost effectiveness, and usability. However, to date, no studies have examined how participants recruited via social media progress through a study compared with those recruited using more traditional recruitment strategies. Objectives (1) Examine whether visiting the study website prior to being contacted by researchers creates self-screened participants who are more likely to progress through all study phases (eligible, enrolled, completed); (2) compare conversion percentages and cost effectiveness of each recruitment method at each study phase; and, (3) compare demographic and smoking characteristics of participants recruited through each strategy to determine if they attract similar samples. Methods Participants recruited to a smoking cessation clinical trial were grouped by how they had become aware of the study: via social media (Facebook) or traditional media (eg, newspaper, flyers, radio, word of mouth). Groups were compared based on throughput data (conversion percentages and cost) as well as demographic and smoking characteristics. Results Visiting the study website did not result in individuals who were more likely to be eligible for (P=.24), enroll in (P=.20), or complete (P=.25) the study. While using social media was more cost effective than traditional methods when we examined earlier endpoints of the recruitment process (cost to obtain a screened respondent: AUD $22.73 vs $29.35; cost to obtain an eligible respondent: $37.56 vs $44.77), it was

  20. The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial.

    Science.gov (United States)

    Frandsen, Mai; Thow, Megan; Ferguson, Stuart G

    2016-08-10

    Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-reach populations), cost effectiveness, and usability. However, to date, no studies have examined how participants recruited via social media progress through a study compared with those recruited using more traditional recruitment strategies. (1) Examine whether visiting the study website prior to being contacted by researchers creates self-screened participants who are more likely to progress through all study phases (eligible, enrolled, completed); (2) compare conversion percentages and cost effectiveness of each recruitment method at each study phase; and, (3) compare demographic and smoking characteristics of participants recruited through each strategy to determine if they attract similar samples. Participants recruited to a smoking cessation clinical trial were grouped by how they had become aware of the study: via social media (Facebook) or traditional media (eg, newspaper, flyers, radio, word of mouth). Groups were compared based on throughput data (conversion percentages and cost) as well as demographic and smoking characteristics. Visiting the study website did not result in individuals who were more likely to be eligible for (P=.24), enroll in (P=.20), or complete (P=.25) the study. While using social media was more cost effective than traditional methods when we examined earlier endpoints of the recruitment process (cost to obtain a screened respondent: AUD $22.73 vs $29.35; cost to obtain an eligible respondent: $37.56 vs $44.77), it was less cost effective in later endpoints

  1. Self-assessment of clinical nurse mentors as dimensions of professional development and the capability of developing ethical values at nursing students: A correlational research study.

    Science.gov (United States)

    Skela-Savič, Brigita; Kiger, Alice

    2015-10-01

    Providing adequate training for mentors, fostering a positive mentorship culture and establishing the necessary operational procedures for ensuring mentorship quality are the keys to effective clinical mentoring of nursing students. The purpose of the research was to explain different dimensions of clinical mentors' professional development and their capability of developing ethical values in nursing students. A non-experimental quantitative research design was employed. Data were collected by means of a questionnaire administered to the population of clinical mentors (N=143). The total number of questions was 36. Descriptive statistics were used, and bivariate analysis, factor analysis, correlation analysis and linear regression analysis were performed. The professional development of clinical nurse mentors was explained (R(2)=0.256) by career advancement (p=0.000), research and learning (p=0.024) and having a career development plan (p=0.043). Increased professional self-confidence (R(2)=0.188) was explained by career advancement (p=0.000) and the time engaged in record keeping (p=0.028). Responsibility for the development of ethical values in nursing students (R(2)=0.145) was explained by the respondents' level of education (p=0.020) and research and learning (p=0.024). Applying ethical principles and norms into practice (R(2)=0.212) was explained by self-assessed knowledge in ethics (p=0.037) and research and learning (p=0.044). Clinical nurse mentors tended to lack a career development plan, had low work time spent on research and insufficiently participated in education and training activities, which turned out to be significant explanatory factors of their professional development and their capability of developing ethical values in nursing students. The research showed that nursing and higher education managers often failed to assume responsibility for the professional development of clinical nurse mentors. Copyright © 2015 Elsevier Ltd. All rights

  2. Experiences of nursing students and educators during the co-construction of clinical nursing leadership learning activities: A qualitative research and development study.

    Science.gov (United States)

    Ha, Laurence; Pepin, Jacinthe

    2017-08-01

    Student voice posits that students' unique perspectives on teaching and learning can be used in conjunction with those of educators to create meaningful educational activities. The study aimed to describe nursing students' and educators' experiences during the co-construction of educational activities involving clinical nursing leadership. Qualitative research and development model. The study was conducted at a French-Canadian nursing faculty that provides a 3-year undergraduate program. Five undergraduate nursing students, four nursing educators, and the principal investigator formed the co-construction team. Data collected included all documents (written and audio) related to the co-construction process: three 2-hour team meetings, PI's fieldnotes and a focus group discussion that occurred once the co-construction process was completed. Thematic analysis was performed guided by Paillé and Muchielli's (2010) method. Data analysis revealed two interrelated themes: (1) unique, purposeful collaboration and (2) change that makes a difference. A space described as safe, without hierarchy and that included the "right" people helped the team achieve their objective of creating new educational activities on clinical nursing leadership. The two new learning activities developed by the team were perceived as useful for future nursing students. At the individual level, team members appreciated how co-construction helped them understand teaching and learning from new perspectives. A structured, efficient co-construction process contributed to positive changes in the nursing program and participants. Additional research is required to enhance understanding of the factors that facilitate and hinder student-educator collaboration outside the classroom. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Jeanne Dalen

    2010-03-01

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

  4. Exploring the opinions of registered nurses working in a clinical transfusion environment on the contribution of e-learning to personal learning and clinical practice: results of a small scale educational research study.

    Science.gov (United States)

    Cottrell, Susan; Donaldson, Jayne H

    2013-05-01

    To explore the opinions of registered nurses on the Learnbloodtransfusion Module 1: Safe Transfusion Practice e-learning programme to meeting personal learning styles and learning needs. A qualitative research methodology was applied based on the principles of phenomenology. Adopting a convenience sampling plan supported the recruitment of participants who had successfully completed the e-learning course. Thematic analysis from the semi-structured interviews identified common emerging themes through application of Colaizzis framework. Seven participants of total sample population (89) volunteered to participate in the study. Five themes emerged which included learning preferences, interactive learning, course design, patient safety and future learning needs. Findings positively show the e-learning programme captures the learning styles and needs of learners. In particular, learning styles of a reflector, theorist and activist as well as a visual learner can actively engage in the online learning experience. In an attempt to bridge the knowledge practice gap, further opinions are offered on the course design and the application of knowledge to practice following completion of the course. The findings of the small scale research study have shown that the e-learning course does meet the diverse learning styles and needs of nurses working in a clinical transfusion environment. However, technology alone is not sufficient and a blended approach to learning must be adopted to meet bridging the theory practice gap supporting the integration of knowledge to clinical practice. Copyright © 2013 Elsevier Ltd. All rights reserved.

  5. Frequent methodological errors in clinical research.

    Science.gov (United States)

    Silva Aycaguer, L C

    2018-03-07

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

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

    LENUS (Irish Health Repository)

    Condell, Sarah L

    2012-11-01

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

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

    Science.gov (United States)

    Daniel, C; Choquet, R

    2013-01-01

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

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

    Science.gov (United States)

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

    2011-06-16

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

  9. Applying self-determination theory for improved understanding of physiotherapists' rationale for using research in clinical practice: a qualitative study in Sweden.

    Science.gov (United States)

    Dannapfel, Petra; Peolsson, Anneli; Ståhl, Christian; Öberg, Birgitta; Nilsen, Per

    2014-01-01

    Physiotherapists are generally positive to evidence-based practice (EBP) and the use of research in clinical practice, yet many still base clinical decisions on knowledge obtained during their initial education and/or personal experience. Our aim was to explore motivations behind physiotherapists' use of research in clinical practice. Self-Determination Theory was applied to identify the different types of motivation for use of research. This theory posits that all behaviours lie along a continuum of relative autonomy, reflecting the extent to which a person endorses their actions. Eleven focus group interviews were conducted, involving 45 physiotherapists in various settings in Sweden. Data were analysed using qualitative content analysis and the findings compared with Self-Determination Theory using a deductive approach. Motivations underlying physiotherapists use of research in clinical practice were identified. Most physiotherapists expressed autonomous forms of motivation for research use, but some exhibited more controlled motivation. Several implications about how more evidence-based physiotherapy can be achieved are discussed, including the potential to tailor educational programs on EBP to better account for differences in motivation among participants, using autonomously motivated physiotherapists as change agents and creating favourable conditions to encourage autonomous motivation by way of feelings of competence, autonomy and a sense of relatedness.

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

    Science.gov (United States)

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

    2017-08-01

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

  11. Perception of research and predictors of research career: a study ...

    African Journals Online (AJOL)

    Introduction: Acquisition of research experience by medical students is associated with good research pathway at the postgraduate level and also in the pursuit of a research career. Also, it assists the physician to make evidence based decisions in clinical practice. Objectives: Aim of study was to determine the perception of ...

  12. Connecting pre-marketing clinical research and medical practice : opinion-based study of core issues and possible changes in drug regulation

    NARCIS (Netherlands)

    Wieringa, N.F; Peschar, J.L.; Denig, P; de Graeff, P.A.; Vos, R

    2003-01-01

    Objectives: To identify core issues that contribute to the gap between pre-marketing clinical research and practice as seen from the perspective of medical practice, as well as possible changes and potential barriers for closing this gap. Methods: Interviews with 47 physicians and pharmacists who

  13. In Defense of a Social Value Requirement for Clinical Research.

    Science.gov (United States)

    Wendler, David; Rid, Annette

    2017-02-01

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

  14. [Pharmacokinetics and clinical studies on flomoxef in neonates and premature infants. A study of flomoxef in the perinatal collaboration research group].

    Science.gov (United States)

    Fujii, R; Fujita, K; Murono, K; Saijo, M; Kakuya, F; Yoshioka, H; Maruyama, S; Sakata, H; Hiramoto, A; Inyaku, F

    1993-07-01

    .0, 32.7 and 23.4 micrograms/ml, and T1/2 were 2.94, 3.68 and 2.25 hours, respectively. The recovery rates were 35.2-52.9% in the first 6 hours after administration. 2. Clinical studies The number of clinically evaluable cases in the FMOX treatment of premature infants was 199, in which the causative pathogens were identified in 71 cases (A group) and not identified in 128 cases (B group).(ABSTRACT TRUNCATED AT 400 WORDS)

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

    Science.gov (United States)

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

    2018-02-21

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

  16. Comparative studies on drug binding to the purified and pharmaceutical-grade human serum albumins: Bridging between basic research and clinical applications of albumin.

    Science.gov (United States)

    Ashrafi-Kooshk, Mohammad Reza; Ebrahimi, Farangis; Ranjbar, Samira; Ghobadi, Sirous; Moradi, Nastaran; Khodarahmi, Reza

    2015-09-01

    Human serum albumin (HSA), the most abundant protein in blood plasma, is a monomeric multidomain protein that possesses an extraordinary capacity for binding, so that serves as a circulating depot for endogenous and exogenous compounds. During the heat sterilization process, the structure of pharmaceutical-grade HSA may change and some of its activities may be lost. In this study, to provide deeper insight on this issue, we investigated drug-binding and some physicochemical properties of purified albumin (PA) and pharmaceutical-grade albumin (PGA) using two known drugs (indomethacin and ibuprofen). PGA displayed significantly lower drug binding capacity compared to PA. Analysis of the quenching and thermodynamic parameters indicated that intermolecular interactions between the drugs and the proteins are different from each other. Surface hydrophobicity as well as the stability of PGA decreased compared to PA, also surface hydrophobicity of PA and PGA increased upon drugs binding. Also, kinetic analysis of pseudo-esterase activities indicated that Km and Vmax parameters for PGA enzymatic activity are more and less than those of PA, respectively. This in vitro study demonstrates that the specific drug binding of PGA is significantly reduced. Such studies can act as connecting bridge between basic research discoveries and clinical applications. Copyright © 2015 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  17. Clinical utility of new bleeding criteria: a prospective study of evaluation for the Bleeding Academic Research Consortium definition of bleeding in patients undergoing percutaneous coronary intervention.

    Science.gov (United States)

    Choi, Jae-Hyuk; Seo, Jeong-Min; Lee, Dong Hyun; Park, Kyungil; Kim, Young-Dae

    2015-04-01

    The aim of this study was to evaluate the clinical utility of the new bleeding criteria, proposed by the Bleeding Academic Research Consortium (BARC), compared with the old criteria for determining the action of physicians in contact with bleeding events, after percutaneous coronary intervention (PCI). The BARC criteria were independently associated with an increased risk of 1-year mortality after PCI, and provided a predictive value, in regard to 1-year mortality. The standardized bleeding definitions will be expected to help the physician to correctly analyze the bleeding events, to select an optimal treatment, and to objectively compare the results of multiple trials and registries. All the patients undergoing PCI from June to September 2012 were prospectively enrolled. Patients who experienced a bleeding event were further classified, based on three different bleeding severity criteria: BARC, Thrombolysis In Myocardial Infarction (TIMI), and Global Use of Strategies To Open coronary arteries (GUSTO). The primary outcome was the occurrence of bleeding events requiring interruption of antiplatelet therapy (IAT) by physicians. A total of 376 consecutive patients were included in this study. Total bleeding events occurred in 46 patients (12.2%). BARC type ≥2 bleeding occurred in 30 patients (8.0%); however, TIMI major or minor bleeding, and GUSTO moderate or severe bleeding occurred in 6 (1.6%) and 11 patients (2.9%), respectively. Of the 46 patients, 28 (60.9% of patients) required IAT. On receiver-operating characteristic curve analysis, bleeding defined BARC type ≥2 effectively predicted IAT, with a sensitivity of 89.3%, and a specificity of 98.5% (pdefinition may be a more useful tool for the detection of bleeding with clinical relevance, for patients undergoing PCI. Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  18. Supporting rural remote physicians to conduct a study and write a paper: experience of Clinical Research Support Team (CRST)-Jichi.

    Science.gov (United States)

    Matsubara, S; Ohkuchi, A; Kamesaki, T; Ishikawa, S; Nakamura, Y; Matsumoto, M

    2014-01-01

    Jichi Medical University (JMU) is the only medical school in Japan that is devoted solely to producing rural and remote doctors. To support research activities of its graduates, mainly young graduates under obligatory rural service, JMU established a voluntary team, Clinical Research Support Team (CRST)-Jichi. CRST-Jichi consists of current and past JMU faculty members; all of them are specialists of certain medical fields and many are also graduates of JMU who have completed rural service. A client who asks the CRST for advice on study design or editing a paper emails the CRST to ask for support in conducting a study. Then, core members of the CRST assign the job to a registered specialist of the corresponding topic, who becomes a 'responsible supporter' and continues to support the client until a paper has been published. During the 3 years from July 2010, 12 English papers have been published in international peer-review journals, two Japanese papers in domestic journals, and 13 studies are in progress. Ninety-one percent of clients were satisfied with the service, and eighty-two percent considered their papers would not have been published if they had not used the service. Sense of commitment, existence of JMU-graduated specialists, and quick response were reported by clients as major strengths of CRST-Jichi. The experience of CRST-Jichi can potentially be transferred to not only other Japanese medical schools with rural doctor production programs, which are now rapidly increasing as part of a national policy, but also rural medical education systems in other countries.

  19. Prevalence of fibromyalgia in France: a multi-step study research combining national screening and clinical confirmation: The DEFI study (Determination of Epidemiology of FIbromyalgia

    Directory of Open Access Journals (Sweden)

    Ravaud Philippe

    2011-10-01

    Full Text Available Abstract Background Fibromyalgia is a common disease, but little is known on its real prevalence in France. This epidemiological study aimed to assess fibromyalgia (FM prevalence in the French metropolitan population, based on a multi-step sampling analysis, combining national screening and clinical confirmation by trained specialists. Methods a sampling method on the entire national territory was used: patients over 18 years of age accepting to take part in the study were contacted by telephone using the LFES Questionnaire, a screening test for FM. The, for patients detected by the LFESQ, a visit with a FM-trained rheumatologist was proposed to confirm FM, based on 1990 ACR criteria. Each detected patient completed the following self-questionnaires: SF36, HADS, stress VAS, Co-morbidities and Regional pain score. Results 3081 patients were contacted in 5 representative French regions, of which 232 patients were screened for FM. A fibromyalgia diagnosis was then confirmed by rheumatologist in 20 cases (17 female and 3 male, 56.9 ± 13.2 years. The final estimated FM prevalence was 1.6 (CI95: 1.2%; 2.0%. No significant difference was detected between the patients accepting (CS+ and refusing (CS- rheumatologist visit for the SF36 score, regional pain score, stress VAS scale and co-morbidities. In patients detected for FM by the LFESQ, we found a statistically significant decrease in quality of life and a statistically significant increase in stress level in patients with a confirmed diagnosis (FM+ (6.3 ± 1.9 compared to patients with an invalidated diagnosis (FM- (4.4 ± 2.8; p = 0.007. The study also demonstrated a significant association, independently of ACR criteria, between the diagnosis of FM and several factors such as regional pain score > 10, elevated stress level, low SF36 scale score and presence of gastro-intestinal disorder co-morbidities. Conclusion Fibromyalgia is a common condition; the 1.6% prevalence calculated in the French

  20. Feasibility of the "Bring Your Own Device" Model in Clinical Research: Results from a Randomized Controlled Pilot Study of a Mobile Patient Engagement Tool.

    Science.gov (United States)

    Pugliese, Laura; Woodriff, Molly; Crowley, Olga; Lam, Vivian; Sohn, Jeremy; Bradley, Scott

    2016-03-16

    Rising rates of smartphone ownership highlight opportunities for improved mobile application usage in clinical trials. While current methods call for device provisioning, the "bring your own device" (BYOD) model permits participants to use personal phones allowing for improved patient engagement and lowered operational costs. However, more evidence is needed to demonstrate the BYOD model's feasibility in research settings. To assess if CentrosHealth, a mobile application designed to support trial compliance, produces different outcomes in medication adherence and application engagement when distributed through study-provisioned devices compared to the BYOD model. 87 participants were randomly selected to use the mobile application or no intervention for a 28-day pilot study at a 2:1 randomization ratio (2 intervention: 1 control) and asked to consume a twice-daily probiotic supplement. The application users were further randomized into two groups: receiving the application on a personal "BYOD" or study-provided smartphone. In-depth interviews were performed in a randomly-selected subset of the intervention group (five BYOD and five study-provided smartphone users). The BYOD subgroup showed significantly greater engagement than study-provided phone users, as shown by higher application use frequency and duration over the study period. The BYOD subgroup also demonstrated a significant effect of engagement on medication adherence for number of application sessions (unstandardized regression coefficient beta=0.0006, p=0.02) and time spent therein (beta=0.00001, p=0.03). Study-provided phone users showed higher initial adherence rates, but greater decline (5.7%) than BYOD users (0.9%) over the study period. In-depth interviews revealed that participants preferred the BYOD model over using study-provided devices. Results indicate that the BYOD model is feasible in health research settings and improves participant experience, calling for further BYOD model validity

  1. Glutamate in schizophrenia: clinical and research implications.

    Science.gov (United States)

    Goff, D C; Wine, L

    1997-10-30

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

  2. 浅析临床科研不端行为及其对策研究%Study on scientific misconduct Clinical Scientific Research and its Countermeasures

    Institute of Scientific and Technical Information of China (English)

    郑富豪; 张璐; 陈懋; 李琪; 陈刚

    2016-01-01

    This article analyzed the types and causes of clinical research misconduct including the definition and background.We then set up the research management system to control and prevent such misconduct behavior.Our strategy includes using various technical tools to actively carry out clinical research integrity related education and training program,establishing integrated control model,and clinical research misconduct handling mechanism to jointly cope with the problems,to promote a good atmosphere for clinical research and to establish the integrity of the research.Our goal is to promote the medical technology development and to improve the patient care.%本文从临床科研不端行为的定义、背景出发,分析临床科研不端行为常见的类型及原因,提出通过完善课题过程管理和制度建设,利用各种技术工具、积极进行临床科研诚信以及不端行为相关教育培训,采取综合防治模式,建立临床科研不端行为处理机制,共同应对临床科研不端行为,为促进临床科研良好氛围形成,建立诚信的研究环境,促进医学技术发展,为广大人民群众健康服务.

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

    Science.gov (United States)

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

    2015-11-27

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

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

    Science.gov (United States)

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

    2016-03-01

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

  5. 78 FR 28292 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2013-05-14

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

  6. Metapsychological and clinical issues in psychosomatics research.

    Science.gov (United States)

    Press, Jacques

    2016-02-01

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

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

    Science.gov (United States)

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

    2016-03-01

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

  8. clinical and experimental study

    OpenAIRE

    Tornow, Christoph

    2011-01-01

    Posterior capsule opacity (PCO) is a frequent complication in extracapsular cataract extraction in conjunction with an intraocular lens implant. Different studies have shown that a reduction in PCO frequency can be achieved via a number of factors. Lens design is a significant criterion in this process. In this study, two multifocal intraocular lenses (MIOLs) were compared. The design of these lenses differed due to their varying optical principles. They are the refractive MIOL A...

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

    Directory of Open Access Journals (Sweden)

    Sami F Shaban

    2011-03-01

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

  10. Accelerator research studies

    International Nuclear Information System (INIS)

    1990-01-01

    This progress report for the Accelerator Research Studies program at the University of Maryland covers the second year (June 1, 1989 to May 31, 1990) of the current three-year contract period from June 1, 1988 to May 31, 1991, funded by the Department of Energy under Contract No. AC05-85ER40216. The research program is divided into three separate tasks, as follows: the study of Transport and Longitudinal Compression of Intense, High-Brightness Beams; the study of Collective Ion Acceleration by Intense Electron Beams and Pulse-Powered Plasma Focus; the study of Microwave Sources and Parameter Scaling for High-Frequency Linacs. This report consists of three sections in which the progress for each task is documented separately. An introduction and synopsis is presented at the beginning of the progress report for each task

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

    Science.gov (United States)

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

    2016-04-01

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

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

    International Nuclear Information System (INIS)

    Murata, Hajime

    2003-01-01

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

  13. A validation study of the CirCom comorbidity score in an English cirrhosis population using the Clinical Practice Research Datalink

    Directory of Open Access Journals (Sweden)

    Crooks CJ

    2018-01-01

    Full Text Available Colin J Crooks,1,2 Joe West,1,2 Peter Jepsen3,4 1Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK; 2Nottingham Digestive Diseases Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, UK; 3Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark; 4Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark Purpose: The CirCom score has been developed from Danish data as a specific measure of comorbidity for cirrhosis to predict all-cause mortality. We compared its performance with the Charlson Comorbidity Index (CCI in an English cirrhosis population. Patients and methods: We used comorbidity scores in a survival model to predict mortality in a cirrhosis cohort in the Clinical Practice Research Datalink. The discrimination of each score was compared by age, gender, socioeconomic status, cirrhosis etiology, cirrhosis stage, and year after cirrhosis diagnosis. We also measured their ability to predict liver-related versus non-liver-related death.Results: There was a small improvement in the C statistic from the model using the CirCom score (C=0.63 compared to the CCI (C=0.62, and there was an overall improvement in the net reclassification index of 1.5%. The improvement was more notable in younger patients, those with an alcohol etiology, and those with compensated cirrhosis. Both scores performed better (C statistic >0.7 for non-liver-related deaths than liver-related deaths (C statistic <0.6, as comorbidity was only weakly predictive of liver-related death.Conclusion: The CirCom score provided a small improvement in performance over the CCI in the prediction of all-cause and non-liver mortality, but not liver-related mortality. Therefore, it is important to include a measure of comorbidity in studies of cirrhosis survival, alongside a measure of cirrhosis severity. Keywords: cirrhosis, mortality, comorbidity, prognosis

  14. [Clinical research XXIII. From clinical judgment to meta-analyses].

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2017-07-01

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

  16. The Influence of Body Mass Index on Outcomes in Ureteroscopy: Results from the Clinical Research Office of Endourological Society URS Global Study.

    Science.gov (United States)

    Krambeck, Amy; Wijnstok, Nienke; Olbert, Peter; Mitroi, George; Bariol, Simon; Shah, Hemendra N; El-Abd, Ahmed S; Onal, Bulent; de la Rosette, Jean

    2017-01-01

    Although ureteroscopy (URS) has been established as a viable treatment for stones in obese patients, its safety and success has not been fully elucidated. The current study describes the worldwide prevalence of obesity in patients with urolithiasis and examines trends in URS outcomes, safety, and efficacy. This study utilized the Clinical Research Office of the Endourological Society (CROES) URS Global Study, which was a prospective, multicenter study including 11,885 patients treated with URS for urinary stones at 1 of 114 urology departments across 32 countries. The relationship between body mass index (BMI), diabetes, and creatinine, with retreatment, stone-free rates, complications, and long hospital stay, was examined with a multivariate logistic regression analyses. Of the 10,099 URS patients with BMI data, 17.4% were obese and 2.2% were super obese. Overall, 86.7% patients were stone free and 16.8% required retreatment. Higher BMI was associated with lower stone-free rates, and any deviation from normal weight was associated with higher retreatment rates. In multivariate analysis controlling for several variables including stone size, the association between BMI and lower stone-free rates with higher retreatment rates persisted. Intraoperative complications occurred in 518 (5.1%) patients, and 343 (3.4%) experienced a postoperative complication. Postoperative complications were more frequent in the underweight and super obese subjects, and there was no relationship between BMI and intraoperative complications. Although URS for stone disease was found to be an overall safe procedure for obese and super obese patients, efficacy of the procedure may be lower compared with normal-weight subjects and higher retreatment rates may be necessary.

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

    African Journals Online (AJOL)

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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

  20. Clinical Research Nursing: Development of a Residency Program
.

    Science.gov (United States)

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

    2017-10-01

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

  1. Report of the Task Force on Clinical Research in Dentistry.

    Science.gov (United States)

    Journal of Dental Education, 1994

    1994-01-01

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

  2. Controlled clinical studies of homeopathy.

    Science.gov (United States)

    Mathie, Robert T

    2015-10-01

    Observations about controlled clinical trials expressed by Max Haidvogl in the book Ultra High Dilution (1994) have been appraised from a perspective two decades later. The present commentary briefly examines changes in homeopathy research evidence since 1994 as regards: the published number of randomised controlled trials (RCTs), the use of individualised homeopathic intervention, the 'proven efficacy of homeopathy', and the quality of the evidence. The commentary reflects the details of RCTs that are available in a recently published literature review and by scrutiny of systematic reviews of RCTs in homeopathy. The homeopathy RCT literature grew by 309 records in the 18 years that immediately followed Haidvogl's article, with more than a doubling of the proportion that investigated individualised homeopathy. Discounting one prior publication, the entire systematic review literature on homeopathy RCTs post-dates 1994. A total of 36 condition-specific systematic reviews have been identified in the peer-reviewed literature: 16 of them reported positive, or tentatively positive, conclusions about homeopathy's clinical effectiveness; the other 20 were negative or non-conclusive. Reviews typically have been restricted in the strength of their conclusions by the low quality of the original RCT evidence. Three comprehensive systematic reviews concluded, cautiously, that homeopathy may differ from placebo; a fourth such review reached negative conclusions. A recent high-quality meta-analysis concluded that medicines prescribed in individualised homeopathic treatment may have small, specific, effects. Despite important growth in research activity since 1994, concerns about study quality limit the interpretation of available RCT data. The question whether homeopathic intervention differs from placebo awaits decisive answer. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  3. Importance of Pharmaceutical Training and Clinical Research at Medical Facilities.

    Science.gov (United States)

    Myotoku, Michiaki

    2017-01-01

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

  4. Are research papers reporting results from nutrigenetics clinical research a potential source of biohype?

    Science.gov (United States)

    Stenne, R; Hurlimann, T; Godard, Béatrice

    2012-01-01

    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.

  5. [Source data management in clinical researches].

    Science.gov (United States)

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

    2015-11-01

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

  6. Bioethical Issues in Conducting Pediatric Dentistry Clinical Research.

    Science.gov (United States)

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

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

  7. Objectivist case study research

    DEFF Research Database (Denmark)

    Ridder, Hanne Mette Ochsner; Fachner, Jörg

    2016-01-01

    be achieved through the use of objectivist case study research. The strength of the case study design is that it allows for uncovering or suggesting causal relationships in real-life settings through an intensive and rich collection of data. According to Hilliard (1993), the opposite applies for extensive......In order to comprehend the impact of music therapy or music therapy processes, a researcher might look for an approach where the topic under investigation can be understood within a broader context. This calls for a rich inclusion of data and consequently a limited number of participants and may...... designs, in which a small amount of data is gathered on a large number of subjects. With the richness of data, the intensive design is ―the primary pragmatic reason for engaging in single-case or small N research‖ (p. 374) and for working from an idiographic rather than a nomothetic perspective....

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

    Science.gov (United States)

    Trevarthen, C; Aitken, K J

    2001-01-01

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

  9. Preoperative JJ stent placement in ureteric and renal stone treatment: results from the Clinical Research Office of Endourological Society (CROES) ureteroscopy (URS) Global Study.

    Science.gov (United States)

    Assimos, Dean; Crisci, Alfonso; Culkin, Daniel; Xue, Wei; Roelofs, Anita; Duvdevani, Mordechai; Desai, Mahesh; de la Rosette, Jean

    2016-04-01

    To compare outcomes of ureteric and renal stone treatment with ureteroscopy (URS) in patients with or without the placement of a preoperative JJ stent. The Clinical Research Office of the Endourological Society (CROES) URS Global Study collected prospective data for 1 year on consecutive patients with ureteric or renal stones treated with URS at 114 centres around the world. Patients that had had preoperative JJ stent placement were compared with those that did not. Inverse-probability-weighted regression adjustment (IPWRA) was used to examine the effect of preoperative JJ stent placement on the stone-free rate (SFR), length of hospital stay (LOHS), operative duration, and complications (rate and severity). Of 8 189 patients with ureteric stones, there were 978 (11.9%) and 7 133 patients with and without a preoperative JJ stent, respectively. Of the 1 622 patients with renal stones, 590 (36.4%) had preoperative stenting and 1 002 did not. For renal stone treatment, preoperative stent placement increased the SFR and operative time, and there was a borderline significant decrease in intraoperative complications. For ureteric stone treatment, preoperative stent placement was associated with longer operative duration and decreased LOHS, but there was no difference in the SFR and complications. One major limitation of the study was that the reason for JJ stent placement was not identified preoperatively. The placement of a preoperative JJ stent increases SFRs and decreases complications in patients with renal stones but not in those with ureteric stones. © 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.

  10. Cancer recording in patients with and without type 2 diabetes in the Clinical Practice Research Datalink primary care data and linked hospital admission data: a cohort study.

    Science.gov (United States)

    Williams, Rachael; van Staa, Tjeerd-Pieter; Gallagher, Arlene M; Hammad, Tarek; Leufkens, Hubert G M; de Vries, Frank

    2018-05-26

    Conflicting results from studies using electronic health records to evaluate the associations between type 2 diabetes and cancer fuel concerns regarding potential biases. This study aimed to describe completeness of cancer recording in UK primary care data linked to hospital admissions records. Patients aged 40+ years with insulin or oral antidiabetic prescriptions in Clinical Practice Research Datalink (CPRD) primary care without type 1 diabetes were matched by age, sex and general practitioner practice to non-diabetics. Those eligible for linkage to Hospital Episode Statistics Admitted Patient Care (HES APC), and with follow-up during April 1997-December 2006 were included. Cancer recording and date of first record of cancer were compared. Characteristics of patients with cancer most likely to have the diagnosis recorded only in a single data source were assessed. Relative rates of cancer estimated from the two datasets were compared. 53 585 patients with type 2 diabetes matched to 47 435 patients without diabetes were included. Of all cancers (excluding non-melanoma skin cancer) recorded in CPRD, 83% were recorded in HES APC. 94% of cases in HES APC were recorded in CPRD. Concordance was lower when restricted to same-site cancer records, and was negatively associated with increasing age. Relative rates for cancer were similar in both datasets. Good concordance in cancer recording was found between CPRD and HES APC among type 2 diabetics and matched controls. Linked data may reduce misclassification and increase case ascertainment when analysis focuses on site-specific cancers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations.

    Science.gov (United States)

    Pierre, Christine

    2008-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

  13. Case Study Research Methodology in Nursing Research.

    Science.gov (United States)

    Cope, Diane G

    2015-11-01

    Through data collection methods using a holistic approach that focuses on variables in a natural setting, qualitative research methods seek to understand participants' perceptions and interpretations. Common qualitative research methods include ethnography, phenomenology, grounded theory, and historic research. Another type of methodology that has a similar qualitative approach is case study research, which seeks to understand a phenomenon or case from multiple perspectives within a given real-world context.

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

    Science.gov (United States)

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

    2014-07-01

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

  15. What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Louise Dudley

    Full Text Available Patient and public involvement (PPI is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact.Semi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation.We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups and managerial (e.g. trial management groups roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees.Those seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.

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

    Science.gov (United States)

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

    2016-05-01

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

  17. Accelerator research studies

    International Nuclear Information System (INIS)

    1993-01-01

    The Accelerator Research Studies program at the University of Maryland, sponsored by the Department of Energy under grant number DE-FG05-91ER40642, is currently in the second year of a three-year funding cycle. The program consists of the following three tasks: TASK A, ''Study of Transport and Longitudinal Compression of Intense, High-Brightness Beams,'' (P.I., M. Reiser); TASK B, ''Study of Collective Ion Acceleration by Intense Electron Beams and Pseudospark Produced High Brightness Electron Beams,'' (Co-P.I.'s, W.W. Destler, M. Reiser, M.J. Rhee, and C.D. Striffler); TASK C, ''Study of a Gyroklystron High-Power Microwave Source for Linear Colliders,'' (Co-P.I.'s, V.L. Granatstein, W. Lawson, M. Reiser, and C.D. Striffler). In this report we document the progress that has been made during the past year for each of the three tasks

  18. Accelerator research studies

    International Nuclear Information System (INIS)

    1992-01-01

    The Accelerator Research Studies program at the University of Maryland, sponsored by the Department of Energy under grant number DE-FG05-91ER40642, is currently in the first year of a three-year funding cycle. The program consists of the following three tasks: TASK A, Study of Transport and Longitudinal Compression of Intense, High-Brightness Beams, TASK B, Study of Collective Ion Acceleration by Intense Electron Beams and Pseudospark Produced High Brightness Electron Beams; TASK C, Study of a Gyroklystron High-power Microwave Source for Linear Colliders. In this report we document the progress that has been made during the past year for each of the three tasks

  19. Colon cleansing protocol in children: research conditions vs. clinical practice.

    Science.gov (United States)

    Elitsur, Yoram; Balfaqih, Yaslam; Preston, Deborah

    2018-04-01

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

  20. 77 FR 26069 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2012-05-02

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

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

    Directory of Open Access Journals (Sweden)

    Charlesworth Lisa

    2011-06-01

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

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

    Directory of Open Access Journals (Sweden)

    James D. Chalmers

    2017-09-01

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

  3. A little more conversation please? Qualitative study of researchers' and patients' interview accounts of training for patient and public involvement in clinical trials.

    Science.gov (United States)

    Dudley, Louise; Gamble, Carrol; Allam, Alison; Bell, Philip; Buck, Deborah; Goodare, Heather; Hanley, Bec; Preston, Jennifer; Walker, Alison; Williamson, Paula; Young, Bridget

    2015-04-27

    Training in patient and public involvement (PPI) is recommended, yet little is known about what training is needed. We explored researchers' and PPI contributors' accounts of PPI activity and training to inform the design of PPI training for both parties. We used semi-structured qualitative interviews with researchers (chief investigators and trial managers) and PPI contributors, accessed through a cohort of clinical trials, which had been funded between 2006 and 2010. An analysis of transcripts of audio-recorded interviews drew on the constant comparative method. We interviewed 31 researchers and 17 PPI contributors from 28 trials. Most researchers could see some value in PPI training for researchers, although just under half had received such training themselves, and some had concerns about the purpose and evidence base for PPI training. PPI contributors were evenly split in their perceptions of whether researchers needed training in PPI. Few PPI contributors had themselves received training for their roles. Many informants across all groups felt that training PPI contributors was unnecessary because they already possessed the skills needed. Informants were also concerned that training would professionalise PPI contributors, limiting their ability to provide an authentic patient perspective. However, informants welcomed informal induction 'conversations' to help contributors understand their roles and support them in voicing their opinions. Informants believed that PPI contributors should be confident, motivated, intelligent, focussed on helping others and have relevant experience. Researchers looked for these qualities when selecting contributors, and spoke of how finding 'the right' contributor was more important than accessing 'the right' training. While informants were broadly receptive to PPI training for researchers, they expressed considerable reluctance to training PPI contributors. Providers of training will need to address these reservations. Our

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

    Science.gov (United States)

    Khong, T Y

    2009-09-01

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

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

    Science.gov (United States)

    Barisoni, Laura; Hodgin, Jeffrey B

    2017-11-01

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

  6. Definition of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage as an Outcome Event in Clinical Trials and Observational Studies Proposal of a Multidisciplinary Research Group

    NARCIS (Netherlands)

    Vergouwen, Mervyn D. I.; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J. E.; Wijdicks, Eelco F.; Muizelaar, J. Paul; Mendelow, A. David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G.; Macdonald, R. Loch; Diringer, Michael N.; Broderick, Joseph P.; Dreier, Jens P.; Roos, Yvo B. W. E. M.

    2010-01-01

    Background and Purpose-In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of

  7. The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial

    OpenAIRE

    Frandsen, Mai; Thow, Megan; Ferguson, Stuart G

    2016-01-01

    Background Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-re...

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

    Science.gov (United States)

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

    2015-10-01

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

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

    Science.gov (United States)

    Zhang, Junhua; Zhang, Boli

    2014-09-01

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

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

    DEFF Research Database (Denmark)

    Smed, Marie; Getz, Kenneth A.

    2014-01-01

    Investigative sites participating in clinical trials play an instrumental role in aiding market adoption. Site experiences in clinical research help physician investigators and research professionals gain familiarity with and exposure to investigational treatments. This knowledge may be passed...

  11. Progress in clinical research of asteroid hyalosis

    Directory of Open Access Journals (Sweden)

    Xiao-Xue Liu

    2017-08-01

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

  12. Understanding clinical reasoning in osteopathy: a qualitative research approach.

    Science.gov (United States)

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

    2016-01-01

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

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

    International Nuclear Information System (INIS)

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

    1989-01-01

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

  14. Functional MRI in children: clinical and research applications

    International Nuclear Information System (INIS)

    Leach, James L.; Holland, Scott K.

    2010-01-01

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

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

    Science.gov (United States)

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

    2014-08-01

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

  16. International market research at the Mayo Clinic.

    Science.gov (United States)

    Hathaway, M; Seltman, K

    2001-01-01

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

  17. Radioisotope studies utilizing a low level whole body counter and clinical applications of activation analysis. Progress report. [Nuclear medicine research studies

    Energy Technology Data Exchange (ETDEWEB)

    Brill, A.B.

    1976-04-30

    Design modifications in radioisotope scanners are discussed. Studies on the radiation dose distribution in patients from /sup 90m/Tc-albumin microspheres in the lungs, /sup 59/Fe-citrate, /sup 131/I-hippuran in kidney transplants, and /sup 99m/Tc-pyrophosphates are reported. Data on the levels of fallout /sup 137/Co in normal individuals during 1975, as measured by whole-body counting, are reported. Results of studies on iodine metabolism in patients with hyperthyroidism and with T/sub 3/-thyrotoxicosis during /sup 131/I therapy with activities up to 17 mCi showed that the apparent volumes of distribution for different iodine compounds do not change appreciably during therapy in this dose range. Methods are described for measuring the content of Ca alone and Ca and P in bone tissues by transmission scanning using a /sup 252/Cf neutron source for activation of Ca and P. (CH)

  18. 76 FR 19188 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-04-06

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research.... Neurobiology-D June 10, 2011 Crowne Plaza DC/Silver Spring. Clinical Research Program June 13, 2011 VA Central...

  19. 78 FR 66992 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2013-11-07

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

  20. 75 FR 57833 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2010-09-22

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research... Crowne Plaza Clinical Research Program December 3, 2010 *VA Central Office Mental Hlth & Behav Sci-A...

  1. 78 FR 22622 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2013-04-16

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

  2. 75 FR 23847 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2010-05-04

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

  3. Conducting Clinically Based Intimate Partner Violence Research: Safety Protocol Recommendations.

    Science.gov (United States)

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

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

  4. The (in)stability of 21st century orthopedic patient contact information and its implications on clinical research: A cross-sectional study.

    Science.gov (United States)

    London, Daniel A; Stepan, Jeffrey G; Goldfarb, Charles A; Boyer, Martin I; Calfee, Ryan P

    2017-04-01

    In clinical research, minimizing patients lost to follow-up is essential for data validity. Researchers can employ better methodology to prevent patient loss. We examined how orthopedic surgery patients' contact information changes over time to optimize data collection for long-term outcomes research. Patients presenting to orthopedic outpatient clinics completed questionnaires regarding methods of contact: home phone, cell phone, mailing address, and e-mail address. They reported currently available methods of contact, if they changed in the past 5 and 10 years, and when they changed. Differences in the rates of change among methods were assessed via Fisher's exact tests. Whether participants changed any of their contact information in the past 5 and 10 years was determined via multivariate modeling, controlling for demographic variables. Among 152 patients, 51% changed at least one form of contact information within 5 years, and 66% changed at least one form within 10 years. The rate of change for each contact method was similar over 5 (15%-28%) and 10 years (26%-41%). One patient changed all four methods of contact within the past 5 years and seven within the past 10 years. Females and younger patients were more likely to change some type of contact information. The type of contact information least likely to change over 5-10 years is influenced by demographic factors such as sex and age, with females and younger participants more likely to change some aspect of their contact information. Collecting all contact methods appears necessary to minimize patients lost to follow-up, especially as technological norms evolve.

  5. The clinical academic workforce of the future: a cross-sectional study of factors influencing career decision-making among clinical PhD students at two research-intensive UK universities.

    Science.gov (United States)

    Lopes, Joana; Ranieri, Veronica; Lambert, Trevor; Pugh, Chris; Barratt, Helen; Fulop, Naomi J; Rees, Geraint; Best, Denise

    2017-08-28

    To examine clinical doctoral students' demographic and training characteristics, career intentions, career preparedness and what influences them as they plan their future careers. Online cross-sectional census surveys at two research-intensive medical schools in England in 2015-2016. All medically qualified PhD students (N=523) enrolled at the University of Oxford and University College London were invited to participate. We report on data from 320 participants (54% male and 44% female), who were representative by gender of the invited population. Career intentions. Respondents were mainly in specialty training, including close to training completion (25%, n=80), and 18% (n=57) had completed training. Half (50%, n=159) intended to pursue a clinical academic career (CAC) and 62% (n=198) were at least moderately likely to seek a clinical lectureship (CL). However, 51% (n=163) had little or no knowledge about CL posts. Those wanting a CAC tended to have the most predoctoral medical research experience (χ 2 (2, N=305)=22.19, p=0.0005). Key reasons cited for not pursuing a CAC were the small number of senior academic appointments available, the difficulty of obtaining research grants and work-life balance. Findings suggest that urging predoctoral clinicians to gain varied research experience while ensuring availability of opportunities, and introducing more flexible recruitment criteria for CL appointments, would foster CACs. As CL posts are often only open to those still in training, the many postdoctoral clinicians who have completed training, or nearly done so, do not currently gain the opportunity the post offers to develop as independent researchers. Better opportunities should be accompanied by enhanced career support for clinical doctoral students (eg, to increase knowledge of CLs). Finally, ways to increase the number of senior clinical academic appointments should be explored since their lack seems to significantly influence career decisions. © Article author

  6. Trends in the incidence of chronic fatigue syndrome and fibromyalgia in the UK, 2001-2013: a Clinical Practice Research Datalink study.

    Science.gov (United States)

    Collin, Simon M; Bakken, Inger J; Nazareth, Irwin; Crawley, Esther; White, Peter D

    2017-06-01

    Objective Trends in recorded diagnoses of chronic fatigue syndrome (CFS, also known as 'myalgic encephalomyelitis' (ME)) and fibromyalgia (FM) in the UK were last reported more than ten years ago, for the period 1990-2001. Our aim was to analyse trends in incident diagnoses of CFS/ME and FM for the period 2001-2013, and to investigate whether incidence might vary by index of multiple deprivation (IMD) score. Design Electronic health records cohort study. Setting NHS primary care practices in the UK. Participants Participants: Patients registered with general practices linked to the Clinical Practice Research Datalink (CPRD) primary care database from January 2001 to December 2013. Main outcome measure Incidence of CFS/ME, FM, post-viral fatigue syndrome (PVFS), and asthenia/debility. Results The overall annual incidence of recorded cases of CFS/ME was 14.8 (95% CI 14.5, 15.1) per 100,000 people. Overall annual incidence per 100,000 people for FM was 33.3 (32.8-33.8), for PVFS 12.2 (11.9, 12.5), and for asthenia/debility 7.0 (6.8, 7.2). Annual incidence rates for CFS/ME diagnoses decreased from 17.5 (16.1, 18.9) in 2001 to 12.6 (11.5, 13.8) in 2013 (annual percent change -2.8% (-3.6%, -2.0%)). Annual incidence rates for FM diagnoses decreased from 32.3 (30.4, 34.3) to 27.1 (25.5, 28.6) in 2007, then increased to 38.2 (36.3, 40.1) per 100,000 people in 2013. Overall annual incidence of recorded fatigue symptoms was 2246 (2242, 2250) per 100,000 people. Compared with the least deprived IMD quintile, incidence of CFS/ME in the most deprived quintile was 39% lower (incidence rate ratio (IRR) 0.61 (0.50, 0.75)), whereas rates of FM were 40% higher (IRR 1.40 (0.95, 2.06)). Conclusion These analyses suggest a gradual decline in recorded diagnoses of CFS/ME since 2001, and an increase in diagnoses of fibromyalgia, with opposing socioeconomic patterns of lower rates of CFS/ME diagnoses in the poorest areas compared with higher rates of FM diagnoses.

  7. Cultural humility: essential foundation for clinical researchers.

    Science.gov (United States)

    Yeager, Katherine A; Bauer-Wu, Susan

    2013-11-01

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

  8. Barriers to Clinical Research in Latin America

    OpenAIRE

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

    2017-01-01

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

  9. Hypofractionated stereotactic irradiation. Basic and clinical researches

    International Nuclear Information System (INIS)

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

    2011-01-01

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

  10. [Current situation of clinical research on impacted premolars].

    Science.gov (United States)

    Liu, Ran-Ran; Tian, Jun

    2018-04-01

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

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

    Science.gov (United States)

    Springate, David A; Kontopantelis, Evangelos; Ashcroft, Darren M; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David

    2014-01-01

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

  12. International Partnerships for Clinical Cancer Research

    Science.gov (United States)

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

  13. The clinical applicability of music therapy research

    DEFF Research Database (Denmark)

    Wigram, Anthony Lewis

    in lengthy and complex theses is seldom accessible to the practitioner working ‘at the coal-face’; and sometimes lacks clear direction on how the results are applicable in everyday therapy. For results to be implemented in clinical practice and disseminated to colleagues in related fields as well as senior...

  14. Discussion of a Well-Designed Clinical Trial Which Did Not Demonstrate Effectiveness: UIC Center for Botanical Dietary Supplements Research Study of Black Cohosh and Red Clover

    Science.gov (United States)

    Shulman, Lee P.; Banuvar, Suzanne; Fong, Harry H. S.; Farnsworth, Norman R.

    2016-01-01

    The performance of a clinical trial for pharmaceutical agents is usually undertaken only after there is likely benefit demonstrated from the use of the putative agent. The consideration of botanical products as pharmaceutical agents must similarly go through a rigorous evaluation process. The present work reviews the recently published Phase II study evaluating the effectiveness of black cohosh and red clover in a randomized trial with conjugated equine estradiol/medroxyprogesterone acetate and placebo for the treatment of menopausal symptoms. We analyze the possible reasons why this study failed to show benefit for either botanical product in reducing menopause-related vasomotor symptoms. PMID:21034798

  15. Serum uric acid is a GFR-independent long-term predictor of acute and chronic renal insufficiency: the Jerusalem Lipid Research Clinic cohort study

    Science.gov (United States)

    Kark, Jeremy D.

    2011-01-01

    Background. Kidney disease is commonly accompanied by hyperuricemia. However, the contribution of serum uric acid (SUA) to kidney injury is debated. Our objective was to assess the long-term prediction of renal failure by SUA. Methods. Visit 2 participants in the Jerusalem Lipid Research Clinic cohort with normal baseline kidney function were followed for 24–28 years. SUA levels were assessed for associations with acute renal failure (ARF) and chronic renal failure (CRF) as defined by hospital discharge records, and mortality, ascertained through linkage with the national population registry. Results. Among 2449 eligible participants (1470 men, 979 women aged 35–78 years in 1976–79), SUA was positively linked with male sex, serum creatinine and components of the metabolic syndrome but was lower in smokers and in diabetic subjects. The 22- to 25-year incidence of hospital-diagnosed kidney failure (145 first events, 67% CRF) and the 24- to 28-year mortality (587 events) were higher in subject with hyperuricemia (>6.5 mg/dL in men and >5.3 mg/dL in women, reflecting the upper quintiles), independent of baseline kidney function and covariates. Hyperuricemia conferred adjusted hazard ratios of 1.36 (P = 0.003), 2.14 (P < 0.001) and 2.87 (P = 0.003) for mortality, CRF and ARF, respectively. Conclusions. SUA predicts renal failure incidence and all-cause mortality independently of demographic and clinical covariates. These results lend support to the undertaking of clinical trials to examine the effect of uric acid-lowering strategies on kidney outcomes. PMID:21220750

  16. Beyond "utilitarianism": maximizing the clinical impact of moral judgment research.

    Science.gov (United States)

    Rosas, Alejandro; Koenigs, Michael

    2014-01-01

    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.

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

    Science.gov (United States)

    National Academies Press, 2011

    2011-01-01

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

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

    Science.gov (United States)

    Halpin, Michael

    2016-06-01

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

  19. 59th Medical Wing Clinical Research Division Clinical Investigations Program Pathology Poster

    Science.gov (United States)

    2017-04-28

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

  20. Frequently Asked Questions about Clinical Research

    Science.gov (United States)

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

  1. Development of a clinical pharmacy model within an Australian home nursing service using co-creation and participatory action research: the Visiting Pharmacist (ViP) study.

    Science.gov (United States)

    Elliott, Rohan A; Lee, Cik Yin; Beanland, Christine; Goeman, Dianne P; Petrie, Neil; Petrie, Barbara; Vise, Felicity; Gray, June

    2017-11-03

    To develop a collaborative, person-centred model of clinical pharmacy support for community nurses and their medication management clients. Co-creation and participatory action research, based on reflection, data collection, interaction and feedback from participants and other stakeholders. A large, non-profit home nursing service in Melbourne, Australia. Older people referred to the home nursing service for medication management, their carers, community nurses, general practitioners (GPs) and pharmacists, a multidisciplinary stakeholder reference group (including consumer representation) and the project team. Feedback and reflections from minutes, notes and transcripts from: project team meetings, clinical pharmacists' reflective diaries and interviews, meetings with community nurses, reference group meetings and interviews and focus groups with 27 older people, 18 carers, 53 nurses, 15 GPs and seven community pharmacists. The model was based on best practice medication management standards and designed to address key medication management issues raised by stakeholders. Pharmacist roles included direct client care and indirect care. Direct care included home visits, medication reconciliation, medication review, medication regimen simplification, preparation of medication lists for clients and nurses, liaison and information sharing with prescribers and pharmacies and patient/carer education. Indirect care included providing medicines information and education for nurses and assisting with review and implementation of organisational medication policies and procedures. The model allowed nurses to refer directly to the pharmacist, enabling timely resolution of medication issues. Direct care was provided to 84 older people over a 15-month implementation period. Ongoing feedback and consultation, in line with participatory action research principles, informed the development and refinement of the model and identification of enablers and challenges. A collaborative

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

    Science.gov (United States)

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

    2017-08-01

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

  3. 77 FR 64598 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2012-10-22

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Sanz Nuria

    2009-10-01

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

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

    LENUS (Irish Health Repository)

    Kubiak, Christine

    2009-10-16

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

  7. Nurse awareness of clinical research: a survey in a Japanese University Hospital

    Science.gov (United States)

    2014-01-01

    . Conclusions These findings suggest that clinical nurses have only limited knowledge on clinical research and the importance to have chances to make nurses aware of clinical research-related issues is suggested to establish an extended research team. Because of the study limitations, further study is warranted to determine the role of clinical nurses in establishing a suitable infrastructure for ethical pursuit of clinical research. PMID:24989623

  8. Establishment of a research pharmacy to support Ebola clinical research in Liberia.

    Science.gov (United States)

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

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

  9. Transforming Research Management Systems at Mayo Clinic

    Science.gov (United States)

    Smith, Steven C.; Gronseth, Darren L.

    2011-01-01

    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…

  10. Systematic review and meta-analysis of studies evaluating diagnostic test accuracy: A practical review for clinical researchers-Part I. general guidance and tips

    International Nuclear Information System (INIS)

    Kim, Kyung Won; Choi, Sang Hyun; Huh, Jimi; Park, Seong Ho; Lee, June Young

    2015-01-01

    In the field of diagnostic test accuracy (DTA), the use of systematic review and meta-analyses is steadily increasing. By means of objective evaluation of all available primary studies, these two processes generate an evidence-based systematic summary regarding a specific research topic. The methodology for systematic review and meta-analysis in DTA studies differs from that in therapeutic/interventional studies, and its content is still evolving. Here we review the overall process from a practical standpoint, which may serve as a reference for those who implement these methods

  11. Social phobia: research and clinical practice.

    Science.gov (United States)

    Alnaes, R

    2001-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

    Fauci, Anthony S.

    1989-01-01

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

  14. Australian research reactor studies

    International Nuclear Information System (INIS)

    McCulloch, D.B.

    1978-01-01

    The Australian AEC has two research reactors at the Lucas Heights Research Establishment, a 10 HW DIDO class materials testing reactor, HIFAR, and a smaller 100kW reactor MOATA, which was recently upgraded from 10kW power level. Because of the HIFAR being some 20 years old, major renewal and repair programmes are necessary to keep it operational. To enable meeting projected increases in demand for radioisotopes, plans for a new reactor to replace the HIFAR have been made and the design criteria are described in the paper. (author)

  15. Testing a model of research intention among U.K. clinical psychologists: a logistic regression analysis.

    Science.gov (United States)

    Eke, Gemma; Holttum, Sue; Hayward, Mark

    2012-03-01

    Previous research highlights barriers to clinical psychologists conducting research, but has rarely examined U.K. clinical psychologists. The study investigated U.K. clinical psychologists' self-reported research output and tested part of a theoretical model of factors influencing their intention to conduct research. Questionnaires were mailed to 1,300 U.K. clinical psychologists. Three hundred and seventy-four questionnaires were returned (29% response-rate). This study replicated in a U.K. sample the finding that the modal number of publications was zero, highlighted in a number of U.K. and U.S. studies. Research intention was bimodally distributed, and logistic regression classified 78% of cases successfully. Outcome expectations, perceived behavioral control and normative beliefs mediated between research training environment and intention. Further research should explore how research is negotiated in clinical roles, and this issue should be incorporated into prequalification training. © 2012 Wiley Periodicals, Inc.

  16. Simulating Data for Clinical Research: A Tutorial

    Science.gov (United States)

    Beaujean, A. Alexander

    2018-01-01

    Simulation studies use computer-generated data to examine questions of interest that have traditionally been used to study properties of statistics and estimating algorithms. With the recent advent of powerful processing capabilities in affordable computers along with readily usable software, it is now feasible to use a simulation study to aid in…

  17. Using Smartphones for Research Outside Clinical Settings: How Operating Systems, App Developers, and Users Determine Geolocation Data Quality in mHealth Studies.

    Science.gov (United States)

    Beukenhorst, A L; Schultz, D M; McBeth, J; Lakshminarayana, R; Sergeant, J C; Dixon, W G

    2017-01-01

    Smartphones that collect user geolocation provid opportunities for mobile Health (mHealth). Although granularity of geolocation data may be high, data completeness depends on the device's operating system, application developer decisions, and user actions. We investigate completeness of geolocation data collected via smartphones of 5601 people that self-reported daily chronic pain symptoms on 349,293 days. On 17% of these days, hourly geolocation data is reported, but days with 0 (16%), 1 (14%) and 2 (13%) geolocations are common. Android phones collect geolocation more often than iPhones (median 17 versus 2 times a day). Factors on operating system level and individual user level influence completeness of geolocation data collected with smartphones. mHealth researchers should be aware of these factors when designing their studies. The mHealth research community should devise standards for reporting geolocation data quality, analysing systematic differences in data quality between participant groups, and methods for data imputation.

  18. The Microcomputer in the Clinical Nursing Research Unit

    Science.gov (United States)

    Schwirian, Patricia M.; Byers, Sandra R.

    1982-01-01

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

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

    Science.gov (United States)

    Zhang, Zhongheng

    2015-11-01

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

  20. Experiences of Latinos with limited English proficiency with patient registration systems and their interactions with clinic front office staff: an exploratory study to inform community-based translational research in North Carolina

    OpenAIRE

    Calo, William A.; Cubillos, Laura; Breen, James; Hall, Megan; Rojas, Krycya Flores; Mooneyham, Rachel; Schaal, Jennifer; Hardy, Christina Yongue; Dave, Gaurav; Jolles, M?nica P?rez; Garcia, Nacire; Reuland, Daniel S.

    2015-01-01

    Background Health services research of Latinos with limited English proficiency (LEP) have largely focused on studying disparities related to patient-provider communication. Less is known about their non-provider interactions such as those with patient registration systems and clinic front office staff; these interactions precede the encounter with providers and may shape how comfortable patients feel about their overall health services experience. This study explored Latino patients with LEP...

  1. A systematic review of methodology applied during preclinical anesthetic neurotoxicity studies: important issues and lessons relevant to the design of future clinical research.

    Science.gov (United States)

    Disma, Nicola; Mondardini, Maria C; Terrando, Niccolò; Absalom, Anthony R; Bilotta, Federico

    2016-01-01

    Preclinical evidence suggests that anesthetic agents harm the developing brain thereby causing long-term neurocognitive impairments. It is not clear if these findings apply to humans, and retrospective epidemiological studies thus far have failed to show definitive evidence that anesthetic agents are harmful to the developing human brain. The aim of this systematic review was to summarize the preclinical studies published over the past decade, with a focus on methodological issues, to facilitate the comparison between different preclinical studies and inform better design of future trials. The literature search identified 941 articles related to the topic of neurotoxicity. As the primary aim of this systematic review was to compare methodologies applied in animal studies to inform future trials, we excluded a priori all articles focused on putative mechanism of neurotoxicity and the neuroprotective agents. Forty-seven preclinical studies were finally included in this review. Methods used in these studies were highly heterogeneous-animals were exposed to anesthetic agents at different developmental stages, in various doses and in various combinations with other drugs, and overall showed diverse toxicity profiles. Physiological monitoring and maintenance of physiological homeostasis was variable and the use of cognitive tests was generally limited to assessment of specific brain areas, with restricted translational relevance to humans. Comparison between studies is thus complicated by this heterogeneous methodology and the relevance of the combined body of literature to humans remains uncertain. Future preclinical studies should use better standardized methodologies to facilitate transferability of findings from preclinical into clinical science. © 2015 John Wiley & Sons Ltd.

  2. Smart Extraction and Analysis System for Clinical Research.

    Science.gov (United States)

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

    2017-05-01

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

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

    LENUS (Irish Health Repository)

    Desmond, A

    2011-04-01

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

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

    Science.gov (United States)

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

    2015-10-24

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

  5. The Meta-Analysis of Clinical Judgment Project: Fifty-Six Years of Accumulated Research on Clinical Versus Statistical Prediction

    Science.gov (United States)

    Aegisdottir, Stefania; White, Michael J.; Spengler, Paul M.; Maugherman, Alan S.; Anderson, Linda A.; Cook, Robert S.; Nichols, Cassandra N.; Lampropoulos, Georgios K.; Walker, Blain S.; Cohen, Genna; Rush, Jeffrey D.

    2006-01-01

    Clinical predictions made by mental health practitioners are compared with those using statistical approaches. Sixty-seven studies were identified from a comprehensive search of 56 years of research; 92 effect sizes were derived from these studies. The overall effect of clinical versus statistical prediction showed a somewhat greater accuracy for…

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

    Science.gov (United States)

    Broach, Debra

    2015-04-01

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

  7. Strategies to successfully recruit and engage clinical nurses as participants in qualitative clinical research.

    Science.gov (United States)

    Coyne, Elisabeth; Grafton, Eileen; Reid, Alayne

    2016-12-01

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

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

    Science.gov (United States)

    Veatch, Robert M

    2016-01-01

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

  9. Anticipate and communicate: Ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumer contexts (December 2013 report of the Presidential Commission for the Study of Bioethical Issues).

    Science.gov (United States)

    Weiner, Christine

    2014-09-15

    Genomic population research increases the possibility of finding genetic coding anomalies that are not the primary object of research but may have significance for the current and future medical care of research participants and progeny. The December 2013 Report of the Presidential Commission for the Study of Bioethical Issues (Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (http://bioethics.gov/sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf)) recommends that a researcher anticipate these findings and make a plan that addresses which findings will be communicated to research participants and how. Following these recommendations will be disruptive for both investigators and institutional review boards (IRBs) until the research community reaches consensus, or a mechanism for evolving consensus, on which results should be returned to research participants. A protocol-by-protocol approach, though laborious, makes sense for both investigators and IRBs as the research community thinks through the implications of genomic research. Epidemiologists will note that discussion of the return of results and the plan for communicating findings should be included in both the participant consent agreement and the research protocol submitted to the IRB. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  10. Evaluating the risks of clinical research: direct comparative analysis.

    Science.gov (United States)

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

    2014-09-01

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

  11. A cancer research UK pharmacokinetic study of BPA-mannitol in patients with high grade glioma to optimise uptake parameters for clinical trials of BNCT

    International Nuclear Information System (INIS)

    Green, S.; James, N.D.; Cruickshank, G.S.

    2006-01-01

    This presentation will describe a human pharmacokinetic study which is scheduled to begin recruitment in Summer 2006. The study has been ongoing for approximately 4 years to develop the necessary protocols, validate boron assays and to develop a new formulation of BPA. The study population will be patients with glioblastoma multiforme and the study focuses on the route of infusion (intra venous or intra carotid artery) and in each will assess the effect of administration of mannitol (as a blood-brain barrier disrupter). Mannitol will be administered as a bolus at the beginning of a two hour infusion of BPA. The BPA formulation (BPA - mannitol) is also new and avoids some of the problems of low solubility associated with BPA-fructose as well as the potential risk of fructose intolerance. The approach will include stereotactic biopsy which is necessary to confirm diagnosis. Tissue samples collected will include needle biopsy samples of tumour and brain around tumour for estimation of BPA transporter expression, together with microdialysis catheter collection of extra-cellular fluid and routine collection of blood and urine for BPA levels. Where possible, according to surgical plan and the route of entry, samples of cerebro-spinal will also be collected. These data will be used to develop a pharmacokinetic model following the general approach already established by others in the field. This paper presents initial pre-clinical studies on the BPA-mannitol formulation and some assay validation work together with suggestions for approaches to normalisation of the macroscopic boron assays using simultaneous measurement of Mg levels in tissue. (author)

  12. Applied Research Study

    Science.gov (United States)

    Leach, Ronald J.

    1997-01-01

    The purpose of this project was to study the feasibility of reusing major components of a software system that had been used to control the operations of a spacecraft launched in the 1980s. The study was done in the context of a ground data processing system that was to be rehosted from a large mainframe to an inexpensive workstation. The study concluded that a systematic approach using inexpensive tools could aid in the reengineering process by identifying a set of certified reusable components. The study also developed procedures for determining duplicate versions of software, which were created because of inadequate naming conventions. Such procedures reduced reengineering costs by approximately 19.4 percent.

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

    Science.gov (United States)

    Bi, Ying-fei; Mao, Jing-yuan

    2012-03-01

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

  14. A 50-year research journey. From laboratory to clinic.

    Science.gov (United States)

    Ross, John

    2009-01-01

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

  15. The importance of clinical case reports in research

    Directory of Open Access Journals (Sweden)

    Ricardo Pineda-Leguízamo

    2018-04-01

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

  16. Basics of case report form designing in clinical research

    Directory of Open Access Journals (Sweden)

    Shantala Bellary

    2014-01-01

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

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

    Science.gov (United States)

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

    2014-10-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

    Shapiro, Robyn S.; Layde, Peter M.

    2008-01-01

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

  20. 76 FR 24974 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-05-03

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

  1. 76 FR 79273 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-12-21

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

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

    Science.gov (United States)

    Akerjordet, Kristin; Lode, Kirsten; Severinsson, Elisabeth

    2012-09-01

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

  3. Translational research into species differences of endocrine toxicity via steroidogenesis inhibition by SMP-028 — For human safety in clinical study

    International Nuclear Information System (INIS)

    Nishizato, Yohei; Imai, Satoki; Okahashi, Noriko; Yabunaka, Atsushi; Kunimatsu, Takeshi; Kikuchi, Kaoru; Yabuki, Masashi

    2014-01-01

    SMP-028 is a drug candidate developed for the treatment of asthma. In a 13-week repeated dose toxicity study of SMP-028 in rats and monkeys, differences of endocrine toxicological events between rats and monkeys were observed. In rats, these toxicological events mainly consisted of pathological changes in the adrenal, testis, ovary, and the other endocrine-related organs. On the other hand, in monkeys, no toxicological events were observed. The goal of this study is to try to understand the reason why only rats, but not monkeys, showed toxicological events following treatment with SMP-028 and to eventually predict the possible toxicological effect of this compound on human endocrine organs. Our results show that SMP-028 inhibits neutral cholesterol esterase more strongly than other steroidogenic enzymes in rats. Although SMP-028 also inhibits monkeys and human neutral cholesterol esterase, this inhibition is much weaker than that of rat neutral cholesterol esterase. These results indicate (1) that the difference in endocrine toxicological events between rats and monkeys is mainly due to inhibition of steroidogenesis by SMP-028 in rats, not in monkeys, and (2) that SMP-028 may not affect steroidogenesis in humans and therefore might cause no endocrine toxicological events in clinical studies. - Highlights: • SMP-028 inhibits neutral CEase more strongly than other steroidogenic enzymes in rats. • Inhibition of neutral CEase in rats by SMP-028 suppresses steroidogenesis in vivo. • SMP-028 does not inhibit neutral CEase in monkeys in vivo. • Steroidogenesis pathway in monkeys treated with SMP-028 was not suppressed. • SMP-028 may not inhibit LIPE in humans in vivo

  4. A cancer research UK pharmacokinetic study of BPA-mannitol in patients with high grade glioma to optimise uptake parameters for clinical trials of BNCT

    Energy Technology Data Exchange (ETDEWEB)

    Cruickshank, G.S. [University of Birmingham and University Hospital Birmingham, Birmingham (United Kingdom)], E-mail: garth.cruickshank@uhb.nhs.uk; Ngoga, D.; Detta, A.; Green, S.; James, N.D.; Wojnecki, C.; Doran, J.; Hardie, J.; Chester, M.; Graham, N.; Ghani, Z. [University of Birmingham and University Hospital Birmingham, Birmingham (United Kingdom); Halbert, G.; Elliot, M.; Ford, S. [CR-UK Formulation Unit, University of Strathclyde, Glasgow (United Kingdom); Braithwaite, R.; Sheehan, T.M.T. [Regional Laboratory for Toxicology, Sandwell and West Birmingham Hospitals Trust, Birmingham (United Kingdom); Vickerman, J.; Lockyer, N. [Surface Analysis Research Centre, University of Manchester, Manchester (United Kingdom); Steinfeldt, H.; Croswell, G. [CR-UK Drug Development Office, London (United Kingdom)] (and others)

    2009-07-15

    This paper describes results to-date from a human pharmacokinetic study which began recruitment in December 2007. Results are presented for a single patient recruited in December 2007. A second patient was recruited in July 2008 but detailed data are not available at the time of writing. The trial is an open-label, non-comparative, non-therapeutic study of BPA-mannitol in patients with high-grade glioma, who will be undergoing stereotactic brain biopsy as part of the diagnostic process before definitive treatment. The study investigates the route of infusion (intra-venous (IV) or intra-carotid artery) and in each case will assess the effect of administration of mannitol as a blood-brain barrier disrupter. All cohorts will receive a 2 h infusion of BPA-mannitol, and for some cohorts an additional mannitol bolus will be administered at the beginning of this infusion. Measurements are made by inductively coupled plasma mass spectrometry (ICP-MS) of {sup 10}B concentration in samples of blood, urine, extra-cellular fluid in normal brain (via a dialysis probe), brain tissue around tumour and tumour tissue. Additional analysis of the tumour tissue is performed using secondary ion mass spectrometry (SIMS). The first patient was part of the cohort having intra-venous infusion without mannitol bolus. No serious clinical problems were experienced and the assay results can be compared with available patient data from other BNCT centres. In particular we note that the peak {sup 10}B concentration in blood was 28.1 mg/ml for a total BPA administration of 350 mg/kg which is very consistent with the previous experience with BPA-fructose reported by the Helsinki group.

  5. A cancer research UK pharmacokinetic study of BPA-mannitol in patients with high grade glioma to optimise uptake parameters for clinical trials of BNCT

    International Nuclear Information System (INIS)

    Cruickshank, G.S.; Ngoga, D.; Detta, A.; Green, S.; James, N.D.; Wojnecki, C.; Doran, J.; Hardie, J.; Chester, M.; Graham, N.; Ghani, Z.; Halbert, G.; Elliot, M.; Ford, S.; Braithwaite, R.; Sheehan, T.M.T.; Vickerman, J.; Lockyer, N.; Steinfeldt, H.; Croswell, G.

    2009-01-01

    This paper describes results to-date from a human pharmacokinetic study which began recruitment in December 2007. Results are presented for a single patient recruited in December 2007. A second patient was recruited in July 2008 but detailed data are not available at the time of writing. The trial is an open-label, non-comparative, non-therapeutic study of BPA-mannitol in patients with high-grade glioma, who will be undergoing stereotactic brain biopsy as part of the diagnostic process before definitive treatment. The study investigates the route of infusion (intra-venous (IV) or intra-carotid artery) and in each case will assess the effect of administration of mannitol as a blood-brain barrier disrupter. All cohorts will receive a 2 h infusion of BPA-mannitol, and for some cohorts an additional mannitol bolus will be administered at the beginning of this infusion. Measurements are made by inductively coupled plasma mass spectrometry (ICP-MS) of 10 B concentration in samples of blood, urine, extra-cellular fluid in normal brain (via a dialysis probe), brain tissue around tumour and tumour tissue. Additional analysis of the tumour tissue is performed using secondary ion mass spectrometry (SIMS). The first patient was part of the cohort having intra-venous infusion without mannitol bolus. No serious clinical problems were experienced and the assay results can be compared with available patient data from other BNCT centres. In particular we note that the peak 10 B concentration in blood was 28.1 mg/ml for a total BPA administration of 350 mg/kg which is very consistent with the previous experience with BPA-fructose reported by the Helsinki group.

  6. Translational research into species differences of endocrine toxicity via steroidogenesis inhibition by SMP-028 — For human safety in clinical study

    Energy Technology Data Exchange (ETDEWEB)

    Nishizato, Yohei, E-mail: yohei-nishizato@ds-pharma.co.jp [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Imai, Satoki [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Okahashi, Noriko [Research Planning and Intelligence, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Yabunaka, Atsushi; Kunimatsu, Takeshi [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Kikuchi, Kaoru [Innovative Drug Discovery Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Yabuki, Masashi [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan)

    2014-05-01

    SMP-028 is a drug candidate developed for the treatment of asthma. In a 13-week repeated dose toxicity study of SMP-028 in rats and monkeys, differences of endocrine toxicological events between rats and monkeys were observed. In rats, these toxicological events mainly consisted of pathological changes in the adrenal, testis, ovary, and the other endocrine-related organs. On the other hand, in monkeys, no toxicological events were observed. The goal of this study is to try to understand the reason why only rats, but not monkeys, showed toxicological events following treatment with SMP-028 and to eventually predict the possible toxicological effect of this compound on human endocrine organs. Our results show that SMP-028 inhibits neutral cholesterol esterase more strongly than other steroidogenic enzymes in rats. Although SMP-028 also inhibits monkeys and human neutral cholesterol esterase, this inhibition is much weaker than that of rat neutral cholesterol esterase. These results indicate (1) that the difference in endocrine toxicological events between rats and monkeys is mainly due to inhibition of steroidogenesis by SMP-028 in rats, not in monkeys, and (2) that SMP-028 may not affect steroidogenesis in humans and therefore might cause no endocrine toxicological events in clinical studies. - Highlights: • SMP-028 inhibits neutral CEase more strongly than other steroidogenic enzymes in rats. • Inhibition of neutral CEase in rats by SMP-028 suppresses steroidogenesis in vivo. • SMP-028 does not inhibit neutral CEase in monkeys in vivo. • Steroidogenesis pathway in monkeys treated with SMP-028 was not suppressed. • SMP-028 may not inhibit LIPE in humans in vivo.

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

    International Nuclear Information System (INIS)

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

    2010-01-01

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

  8. A model for integrating clinical care and basic science research, and pitfalls of performing complex research projects for addressing a clinical challenge.

    Science.gov (United States)

    Steck, R; Epari, D R; Schuetz, M A

    2010-07-01

    The collaboration of clinicians with basic science researchers is crucial for addressing clinically relevant research questions. In order to initiate such mutually beneficial relationships, we propose a model where early career clinicians spend a designated time embedded in established basic science research groups, in order to pursue a postgraduate qualification. During this time, clinicians become integral members of the research team, fostering long term relationships and opening up opportunities for continuing collaboration. However, for these collaborations to be successful there are pitfalls to be avoided. Limited time and funding can lead to attempts to answer clinical challenges with highly complex research projects characterised by a large number of "clinical" factors being introduced in the hope that the research outcomes will be more clinically relevant. As a result, the complexity of such studies and variability of its outcomes may lead to difficulties in drawing scientifically justified and clinically useful conclusions. Consequently, we stress that it is the basic science researcher and the clinician's obligation to be mindful of the limitations and challenges of such multi-factorial research projects. A systematic step-by-step approach to address clinical research questions with limited, but highly targeted and well defined research projects provides the solid foundation which may lead to the development of a longer term research program for addressing more challenging clinical problems. Ultimately, we believe that it is such models, encouraging the vital collaboration between clinicians and researchers for the work on targeted, well defined research projects, which will result in answers to the important clinical challenges of today. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

  9. Depression severity and quality of life of qualified and unqualified patients with a mood disorder for a research study targeting anhedonia in a clinical sample.

    Science.gov (United States)

    Gao, Keming; Sweet, Jennifer; Su, Meilei; Calabrese, Joseph R

    2017-06-01

    To investigate the depression severity and quality of life of qualified and unqualified patients with a mood disorder for a research study based on anhedonia severity. Diagnosis of major depressive disorder (MDD) or bipolar disorder (BPD) was ascertained with the MINI International Neuropsychiatric Interview. The severity of depression was measured with the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-16-SR), and Item 5, "feeling sad (sadness)," QIDS-16-SR Item 13, "change in general interest," was used to measure the severity of anhedonia. The quality of life was measured with the Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Of 96 patients with MDD and 147 with bipolar I or II disorder, the severity rating on sadness and anhedonia was similar. The severities of anhedonia and sadness were highly correlated with R 2 of ≥0.91. Without considering depressive severity, 55% of patients would be eligible for a study if≥mild anhedonia was used as a severity criterion, but only 26% of patients eligible for a study if≥moderate anhedonia was used without considering substance use and medical comorbidities. If patients with ≥ moderate overall depressive symptoms were considered, 88.1% of patients would be eligible if≥mild anhedonia was required for a study, and 45.2% of patients would be eligible for a study if≥moderate anhedonia was required. For those who were unqualified for the study based on≥moderate anhedonia, about 1/3 had≥moderate overall depressive symptoms and less than 40% of maximum possible scores of Q-LES-Q. If only patients in remission based on overall depressive symptom severity were considered for a study of anhedonia, no patient would be eligible for the study. Depressive mood and anhedonia are highly correlated. Screening patients with a mood disorder and an overall moderate depressive severity is a cost-effective approach for a study targeting anhedonia, especially for a study requiring

  10. Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

    Science.gov (United States)

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

    2015-12-01

    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.

  11. Cyclotrons for clinical and biomedical research with PET

    International Nuclear Information System (INIS)

    Wolf, A.P.

    1987-01-01

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

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

    Science.gov (United States)

    Hutchinson, Anastasia; Rubinfeld, Abe R

    2008-08-18

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

  13. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    OpenAIRE

    Eisenstein, Eric L.; Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2010-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators ...

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

    Directory of Open Access Journals (Sweden)

    Essi Sarkkinen

    2012-06-01

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

  15. Clinical Effectiveness of Statin Therapy After Ischemic Stroke: Primary Results From the Statin Therapeutic Area of the Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study.

    Science.gov (United States)

    O'Brien, Emily C; Greiner, Melissa A; Xian, Ying; Fonarow, Gregg C; Olson, DaiWai M; Schwamm, Lee H; Bhatt, Deepak L; Smith, Eric E; Maisch, Lesley; Hannah, Deidre; Lindholm, Brianna; Peterson, Eric D; Pencina, Michael J; Hernandez, Adrian F

    2015-10-13

    In patients with ischemic stroke, data on the real-world effectiveness of statin therapy for clinical and patient-centered outcomes are needed to better inform shared decision making. Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) is a Patient-Centered Outcomes Research Institute-funded research program designed with stroke survivors to evaluate the effectiveness of poststroke therapies. We linked data on patients ≥65 years of age enrolled in the Get With The Guidelines-Stroke Registry to Medicare claims. Two-year to postdischarge outcomes of those discharged on a statin versus not on a statin were adjusted through inverse probability weighting. Our coprimary outcomes were major adverse cardiovascular events and home time (days alive and out of a hospital or skilled nursing facility). Secondary outcomes included all-cause mortality, all-cause readmission, cardiovascular readmission, and hemorrhagic stroke. From 2007 to 2011, 77 468 patients who were not taking statins at the time of admission were hospitalized with ischemic stroke; of these, 71% were discharged on statin therapy. After adjustment, statin therapy at discharge was associated with a lower hazard of major adverse cardiovascular events (hazard ratio, 0.91; 95% confidence interval, 0.87-0.94), 28 more home-time days after discharge (PStatin therapy at discharge was not associated with increased risk of hemorrhagic stroke (hazard ratio, 0.94; 95% confidence interval, 0.72-1.23). Among statin-treated patients, 31% received a high-intensity dose; after risk adjustment, these patients had outcomes similar to those of recipients of moderate-intensity statin. In older ischemic stroke patients who were not taking statins at the time of admission, discharge statin therapy was associated with lower risk of major adverse cardiovascular events and nearly 1 month more home time during the 2-year period after hospitalization. © 2015 American Heart Association

  16. Sex differences in health research and clinical guideline development

    NARCIS (Netherlands)

    Keuken, D.G.

    2008-01-01

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

  17. Radioactive isotopes in clinical medicine and research. Abstracts

    International Nuclear Information System (INIS)

    2007-01-01

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

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

    NARCIS (Netherlands)

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

    2011-01-01

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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

  20. The National Institute of Dental Research Clinical Dental Staff Fellowship.

    Science.gov (United States)

    Baum, Bruce J.; And Others

    1988-01-01

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

  1. Radioactive isotopes in clinical medicine and research. Abstracts

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-07-01

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

  2. Infrastructure resources for clinical research in amyotrophic lateral sclerosis.

    Science.gov (United States)

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

    2013-05-01

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

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

    OpenAIRE

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

    1982-01-01

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

  4. Building research capacity: through a hospital-based clinical school of nursing.

    Science.gov (United States)

    Lee, Geraldine; Metcalf, Suzanne

    2009-04-01

    For clinical nurses and nursing academics wishing to participate in research, there are several logistical issues such as high workloads, lack of time and poor research skills and knowledge that can impede research being undertaken. To address these issues, La Trobe University in partnership with one of Melbourne's acute care hospitals developed a clinical school with the aim of delivering postgraduate courses and undertaking collaborative clinically focused nursing research. Clinical issues were identified jointly between university academics and clinical nursing staff. Research questions were developed to examine these issues with the clinical school staff facilitating the research process. Research has been undertaken in many specialty areas including emergency, cardiac and intensive care nursing and diabetes. The success of this collaboration is evident with many studies being undertaken and consequently dissemination of research findings published (with clinicians being the primary author on many papers), presentations at national and international conferences by clinical staff as well as an increased enrollment into masters and doctoral programmes. The presence of the clinical school at the hospital has been beneficial both to clinicians and nurse academics and resulted in developing a positive research environment. More importantly, the research has led to changes in patient care and enabled clinicians to gain research experience and further academic qualifications. The other benefit is that nurse academics have strengthened their working relationship with clinicians and ensured visible research outputs were achieved.

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

    Science.gov (United States)

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

    2017-07-01

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

  6. Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality

    Science.gov (United States)

    von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G.; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H.; Pauli-Magnus, Christiane; Briel, Matthias

    2017-01-01

    Objective To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. Study design and setting We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Results Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Conclusion Clinical research quality is often discussed but rarely defined. A framework defining

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

    Science.gov (United States)

    Shah, Baiju R; Lipscombe, Lorraine L

    2015-06-01

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

  8. Nuclear medical approaches to clinical research; Nuklearmedizinische Ansaetze in der klinischen Forschung

    Energy Technology Data Exchange (ETDEWEB)

    Otte, Andreas; Nguyen, Tristan (eds.)

    2009-11-15

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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2017-04-01

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

  11. Patient registries: useful tools for clinical research in myasthenia gravis.

    Science.gov (United States)

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

    2012-12-01

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

  12. Is it acceptable to video-record palliative care consultations for research and training purposes? A qualitative interview study exploring the views of hospice patients, carers and clinical staff.

    Science.gov (United States)

    Pino, Marco; Parry, Ruth; Feathers, Luke; Faull, Christina

    2017-09-01

    Research using video recordings can advance understanding of healthcare communication and improve care, but making and using video recordings carries risks. To explore views of hospice patients, carers and clinical staff about whether videoing patient-doctor consultations is acceptable for research and training purposes. We used semi-structured group and individual interviews to gather hospice patients, carers and clinical staff views. We used Braun and Clark's thematic analysis. Interviews were conducted at one English hospice to inform the development of a larger video-based study. We invited patients with capacity to consent and whom the care team judged were neither acutely unwell nor severely distressed (11), carers of current or past patients (5), palliative medicine doctors (7), senior nurses (4) and communication skills educators (5). Participants viewed video-based research on communication as valuable because of its potential to improve communication, care and staff training. Video-based research raised concerns including its potential to affect the nature and content of the consultation and threats to confidentiality; however, these were not seen as sufficient grounds for rejecting video-based research. Video-based research was seen as acceptable and useful providing that measures are taken to reduce possible risks across the recruitment, recording and dissemination phases of the research process. Video-based research is an acceptable and worthwhile way of investigating communication in palliative medicine. Situated judgements should be made about when it is appropriate to involve individual patients and carers in video-based research on the basis of their level of vulnerability and ability to freely consent.

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

    OpenAIRE

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

    2011-01-01

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

  14. Research

    African Journals Online (AJOL)

    The mini-clinical-evaluation exercise (mini-CEX) is a way of assessing the clinical ... Ethical approval for this study was obtained from the Medical Health. Research ..... mini-CEX assessment and feedback session, the greater the likelihood of.

  15. Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report

    OpenAIRE

    Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

    2016-01-01

    Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients i...

  16. Use of electronic monitoring in clinical nursing research.

    Science.gov (United States)

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

    2008-05-01

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

  17. Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

    Directory of Open Access Journals (Sweden)

    Belinda von Niederhäusern

    Full Text Available To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research.We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes.Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives.Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across

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

    Science.gov (United States)

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

    2008-01-01

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

  19. A Clinical Study on Hypothyroidism

    International Nuclear Information System (INIS)

    Park, Keun Jo; Park, Sun Yang; Park, Jung Sik; Lee, Myung Chul; Koh, Chang Soon; Lee, Mun Ho

    1976-01-01

    A clinical study was made on 263 patients of hypothyroidism among the 5,970 patients of Various thyroid diseases diagnosed and treated at the Radioisotope Clinic and Laboratory, Seoul National University Hospital from May, 1960 to Aug, 1975. The results obtained with this study are as follows: 1) The etiological classification of hypothyroidism revealed 244 cases (93%) of primary hypothyroidism and 19 cases (7%) of secondary hypothyroidism. 2) The most frequent cause of the thyroprivic primary hypothyroidism was post radioiodine therapy with 109 cases (41.4%). 3) There were 37 cases (14%) of male and 226 cases (86%) of female, showing a ratio of 1 : 6. 4) The majority of patients were between the ages of 30 and 60 with the peak incidence (87 cases, 33%) in their fourth decades of lives. 5) The major symptoms and signs were weakness (97%), edema of face and extremities (92%); Decreased Achilles tendon reflex (87%), cold intolerance (82%), gain in weight (76%), constipation (58%) and cold skin (51%). 6) The cumulative incidence of hypothyroidism in patient treated with 131 I (3-8 mci) was 7.2% at first year, 33.3% at tenth year and the 50% at fourteenth year and the annual increment was 2.9%. 7) The incidence of hypothyroidism related to the numbers of 131 I therapy was not linear. 8) The diagnostic compatibilities of the various tests to hypothyroidism were TSH (100%), T 4 (93.8%), 24-hour-RNIU (91.5%), ATR (86.7%), T 3 RU (66.1%) and BMR (64.9%).

  20. A Clinical Study on Hypothyroidism

    Energy Technology Data Exchange (ETDEWEB)

    Park, Keun Jo; Park, Sun Yang; Park, Jung Sik; Lee, Myung Chul; Koh, Chang Soon; Lee, Mun Ho [Seoul National University College of Medicine, Seoul (Korea, Republic of)

    1976-03-15

    A clinical study was made on 263 patients of hypothyroidism among the 5,970 patients of Various thyroid diseases diagnosed and treated at the Radioisotope Clinic and Laboratory, Seoul National University Hospital from May, 1960 to Aug, 1975. The results obtained with this study are as follows: 1) The etiological classification of hypothyroidism revealed 244 cases (93%) of primary hypothyroidism and 19 cases (7%) of secondary hypothyroidism. 2) The most frequent cause of the thyroprivic primary hypothyroidism was post radioiodine therapy with 109 cases (41.4%). 3) There were 37 cases (14%) of male and 226 cases (86%) of female, showing a ratio of 1 : 6. 4) The majority of patients were between the ages of 30 and 60 with the peak incidence (87 cases, 33%) in their fourth decades of lives. 5) The major symptoms and signs were weakness (97%), edema of face and extremities (92%); Decreased Achilles tendon reflex (87%), cold intolerance (82%), gain in weight (76%), constipation (58%) and cold skin (51%). 6) The cumulative incidence of hypothyroidism in patient treated with {sup 131}I (3-8 mci) was 7.2% at first year, 33.3% at tenth year and the 50% at fourteenth year and the annual increment was 2.9%. 7) The incidence of hypothyroidism related to the numbers of {sup 131}I therapy was not linear. 8) The diagnostic compatibilities of the various tests to hypothyroidism were TSH (100%), T{sub 4} (93.8%), 24-hour-RNIU (91.5%), ATR (86.7%), T{sub 3}RU (66.1%) and BMR (64.9%).

  1. Understanding clinical reasoning in osteopathy: a qualitative research approach

    OpenAIRE

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

    2016-01-01

    Background Clinical reasoning has been described as a process that draws heavily on the knowledge, skills and attributes that are particular to each health profession. However, the clinical reasoning processes of practitioners of different disciplines demonstrate many similarities, including hypothesis generation and reflective practice. The aim of this study was to understand clinical reasoning in osteopathy from the perspective of osteopathic clinical educators and the extent to which it wa...

  2. A critique of statistical hypothesis testing in clinical research

    Directory of Open Access Journals (Sweden)

    Somik Raha

    2011-01-01

    Full Text Available Many have documented the difficulty of using the current paradigm of Randomized Controlled Trials (RCTs to test and validate the effectiveness of alternative medical systems such as Ayurveda. This paper critiques the applicability of RCTs for all clinical knowledge-seeking endeavors, of which Ayurveda research is a part. This is done by examining statistical hypothesis testing, the underlying foundation of RCTs, from a practical and philosophical perspective. In the philosophical critique, the two main worldviews of probability are that of the Bayesian and the frequentist. The frequentist worldview is a special case of the Bayesian worldview requiring the unrealistic assumptions of knowing nothing about the universe and believing that all observations are unrelated to each ot