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

Science.gov (United States)

Hughes, Rhidian

2005-01-01

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

Using Unified Modelling Language (UML) as a process-modelling technique for clinical-research process improvement.

Science.gov (United States)

Kumarapeli, P; De Lusignan, S; Ellis, T; Jones, B

2007-03-01

The Primary Care Data Quality programme (PCDQ) is a quality-improvement programme which processes routinely collected general practice computer data. Patient data collected from a wide range of different brands of clinical computer systems are aggregated, processed, and fed back to practices in an educational context to improve the quality of care. Process modelling is a well-established approach used to gain understanding and systematic appraisal, and identify areas of improvement of a business process. Unified modelling language (UML) is a general purpose modelling technique used for this purpose. We used UML to appraise the PCDQ process to see if the efficiency and predictability of the process could be improved. Activity analysis and thinking-aloud sessions were used to collect data to generate UML diagrams. The UML model highlighted the sequential nature of the current process as a barrier for efficiency gains. It also identified the uneven distribution of process controls, lack of symmetric communication channels, critical dependencies among processing stages, and failure to implement all the lessons learned in the piloting phase. It also suggested that improved structured reporting at each stage - especially from the pilot phase, parallel processing of data and correctly positioned process controls - should improve the efficiency and predictability of research projects. Process modelling provided a rational basis for the critical appraisal of a clinical data processing system; its potential maybe underutilized within health care.

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

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.

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

Science.gov (United States)

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

2016-01-01

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

The DEDUCE Guided Query tool: providing simplified access to clinical data for research and quality improvement.

Science.gov (United States)

Horvath, Monica M; Winfield, Stephanie; Evans, Steve; Slopek, Steve; Shang, Howard; Ferranti, Jeffrey

2011-04-01

In many healthcare organizations, comparative effectiveness research and quality improvement (QI) investigations are hampered by a lack of access to data created as a byproduct of patient care. Data collection often hinges upon either manual chart review or ad hoc requests to technical experts who support legacy clinical systems. In order to facilitate this needed capacity for data exploration at our institution (Duke University Health System), we have designed and deployed a robust Web application for cohort identification and data extraction--the Duke Enterprise Data Unified Content Explorer (DEDUCE). DEDUCE is envisioned as a simple, web-based environment that allows investigators access to administrative, financial, and clinical information generated during patient care. By using business intelligence tools to create a view into Duke Medicine's enterprise data warehouse, DEDUCE provides a Guided Query functionality using a wizard-like interface that lets users filter through millions of clinical records, explore aggregate reports, and, export extracts. Researchers and QI specialists can obtain detailed patient- and observation-level extracts without needing to understand structured query language or the underlying database model. Developers designing such tools must devote sufficient training and develop application safeguards to ensure that patient-centered clinical researchers understand when observation-level extracts should be used. This may mitigate the risk of data being misunderstood and consequently used in an improper fashion. Copyright © 2010 Elsevier Inc. All rights reserved.

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.

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....

[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.

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.

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

NARCIS (Netherlands)

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

2013-01-01

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

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…

Platelet Immunology in China: Research and Clinical Applications.

Science.gov (United States)

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

2017-04-01

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

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

Using Relational Reasoning Strategies to Help Improve Clinical Reasoning Practice.

Science.gov (United States)

Dumas, Denis; Torre, Dario M; Durning, Steven J

2018-05-01

Clinical reasoning-the steps up to and including establishing a diagnosis and/or therapy-is a fundamentally important mental process for physicians. Unfortunately, mounting evidence suggests that errors in clinical reasoning lead to substantial problems for medical professionals and patients alike, including suboptimal care, malpractice claims, and rising health care costs. For this reason, cognitive strategies by which clinical reasoning may be improved-and that many expert clinicians are already using-are highly relevant for all medical professionals, educators, and learners.In this Perspective, the authors introduce one group of cognitive strategies-termed relational reasoning strategies-that have been empirically shown, through limited educational and psychological research, to improve the accuracy of learners' reasoning both within and outside of the medical disciplines. The authors contend that relational reasoning strategies may help clinicians to be metacognitive about their own clinical reasoning; such strategies may also be particularly well suited for explicitly organizing clinical reasoning instruction for learners. Because the particular curricular efforts that may improve the relational reasoning of medical students are not known at this point, the authors describe the nature of previous research on relational reasoning strategies to encourage the future design, implementation, and evaluation of instructional interventions for relational reasoning within the medical education literature. The authors also call for continued research on using relational reasoning strategies and their role in clinical practice and medical education, with the long-term goal of improving diagnostic accuracy.

[Educative strategy evaluation to improve critical reading skills on clinical research texts in second year gyneco-obstetrics residents].

Science.gov (United States)

Carranza Lira, Sebastián; Arce Herrera, Rosa María; González González, Patricia

2007-11-01

The educative models and strategies to achieve a significant learning have a wide variety. The development of clinical aptitude for clinical research papers lecture has an important place to maintain the physician actualized and for resident formation. To evaluate the degree of development of the aptitude for the reading of clinical research articles in 2nd grade residents of the gynecology and obstetrics speciality alter an educative strategy. In 16 2nd year gynecology and obstetrics residents, a previously validated instrument was applied for the evaluation of critical lecture of clinical research articles in general medicine previous and after and educative strategy. Statistical analysis was with Kruskal-Wallis analysis of variance. Also Wilcoxon test was used to assess the differences between baseline and final results. The median of age was 27 (24-31) years, gender 56.3% women and 43.8% men. A statistically significant increase in global score was observed after the educative strategy. After it only there was a significant increase in the indicator to interpret. After evaluating the domain degrees according to the indicator to interpret, in baseline evaluation it predominated the very low level and at the final evaluation the very low and low levels. In the indicator to judge at baseline the majority were in the very low level, and at the end in very low and low levels. According to the indicator to propose at baseline all were in the level expected by hazard, and at the end a minimal proportion was at very low level. These results traduce a discrete improvement in critical lecture process, which makes to consider the educative strategy that was used, since the objective to improve critical lecture capacity was not achieved.

The applicability of Lean and Six Sigma techniques to clinical and translational research.

Science.gov (United States)

Schweikhart, Sharon A; Dembe, Allard E

2009-10-01

Lean and Six Sigma are business management strategies commonly used in production industries to improve process efficiency and quality. During the past decade, these process improvement techniques increasingly have been applied outside the manufacturing sector, for example, in health care and in software development. This article concerns the potential use of Lean and Six Sigma in improving the processes involved in clinical and translational research. Improving quality, avoiding delays and errors, and speeding up the time to implementation of biomedical discoveries are prime objectives of the National Institutes of Health (NIH) Roadmap for Medical Research and the NIH's Clinical and Translational Science Award program. This article presents a description of the main principles, practices, and methods used in Lean and Six Sigma. Available literature involving applications of Lean and Six Sigma to health care, laboratory science, and clinical and translational research is reviewed. Specific issues concerning the use of these techniques in different phases of translational research are identified. Examples of Lean and Six Sigma applications that are being planned at a current Clinical and Translational Science Award site are provided, which could potentially be replicated elsewhere. We describe how different process improvement approaches are best adapted for particular translational research phases. Lean and Six Sigma process improvement methods are well suited to help achieve NIH's goal of making clinical and translational research more efficient and cost-effective, enhancing the quality of the research, and facilitating the successful adoption of biomedical research findings into practice.

Nuclear separations for radiopharmacy : the need for improved separations to meet future research and clinical demands

International Nuclear Information System (INIS)

Bond, A.H.; Rogers, R.D.; Dietz, M.L.

2000-01-01

Several recent national and international reports have predicted that the demand for radionuclides used in medicine will increase significantly over the next 20 years. Separation science is an integral part of the production and development of new radionuclides for diagnostic and therapeutic applications and will play a major role in process improvements to existing radiopharmaceuticals to meet increasing demands. The role of separation science in the production of radionuclides for medical applications is briefly discussed, followed by an overview of the manuscripts from the American Chemical Society symposium 'Nuclear Separations for Radiopharmacy'. A listing of the most widely used radionuclides in clinical application and medical research serves as a foundation for the discussion of future research opportunities in separation science

Structured clinical documentation in the electronic medical record to improve quality and to support practice-based research in epilepsy.

Science.gov (United States)

Narayanan, Jaishree; Dobrin, Sofia; Choi, Janet; Rubin, Susan; Pham, Anna; Patel, Vimal; Frigerio, Roberta; Maurer, Darryck; Gupta, Payal; Link, Lourdes; Walters, Shaun; Wang, Chi; Ji, Yuan; Maraganore, Demetrius M

2017-01-01

Using the electronic medical record (EMR) to capture structured clinical data at the point of care would be a practical way to support quality improvement and practice-based research in epilepsy. We describe our stepwise process for building structured clinical documentation support tools in the EMR that define best practices in epilepsy, and we describe how we incorporated these toolkits into our clinical workflow. These tools write notes and capture hundreds of fields of data including several score tests: Generalized Anxiety Disorder-7 items, Neurological Disorders Depression Inventory for Epilepsy, Epworth Sleepiness Scale, Quality of Life in Epilepsy-10 items, Montreal Cognitive Assessment/Short Test of Mental Status, and Medical Research Council Prognostic Index. The tools summarize brain imaging, blood laboratory, and electroencephalography results, and document neuromodulation treatments. The tools provide Best Practices Advisories and other clinical decision support when appropriate. The tools prompt enrollment in a DNA biobanking study. We have thus far enrolled 231 patients for initial visits and are starting our first annual follow-up visits and provide a brief description of our cohort. We are sharing these EMR tools and captured data with other epilepsy clinics as part of a Neurology Practice Based Research Network, and are using the tools to conduct pragmatic trials using subgroup-based adaptive designs. © 2016 The Authors. Epilepsia published by Wiley Periodicals, Inc. on behalf of International League Against Epilepsy.

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

Science.gov (United States)

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

2015-01-01

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

Radioprotectors and Radiomitigators for Improving Radiation Therapy: The Small Business Innovation Research (SBIR) Gateway for Accelerating Clinical Translation.

Science.gov (United States)

Prasanna, Pataje G S; Narayanan, Deepa; Hallett, Kory; Bernhard, Eric J; Ahmed, Mansoor M; Evans, Gregory; Vikram, Bhadrasain; Weingarten, Michael; Coleman, C Norman

2015-09-01

Although radiation therapy is an important cancer treatment modality, patients may experience adverse effects. The use of a radiation-effect modulator may help improve the outcome and health-related quality of life (HRQOL) of patients undergoing radiation therapy either by enhancing tumor cell killing or by protecting normal tissues. Historically, the successful translation of radiation-effect modulators to the clinic has been hindered due to the lack of focused collaboration between academia, pharmaceutical companies and the clinic, along with limited availability of support for such ventures. The U.S. Government has been developing medical countermeasures against accidental and intentional radiation exposures to mitigate the risk and/or severity of acute radiation syndrome (ARS) and the delayed effects of acute radiation exposures (DEARE), and there is now a drug development pipeline established. Some of these medical countermeasures could potentially be repurposed for improving the outcome of radiation therapy and HRQOL of cancer patients. With the objective of developing radiation-effect modulators to improve radiotherapy, the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI), supported by the Radiation Research Program (RRP), provided funding to companies from 2011 to 2014 through the SBIR contracts mechanism. Although radiation-effect modulators collectively refer to radioprotectors, radiomitigators and radiosensitizers, the focus of this article is on radioprotection and mitigation of radiation injury. This specific SBIR contract opportunity strengthened existing partnerships and facilitated new collaborations between academia and industry. In this commentary, we assess the impact of this funding opportunity, outline the review process, highlight the organ/site-specific disease needs in the clinic for the development of radiation-effect modulators, provide a general understanding of a framework for gathering

Drug-eluting stents: from bench-top to clinical research

NARCIS (Netherlands)

Basalus, Mounir Welson Zakhary

2013-01-01

The development of drug-eluting stents (DES) has improved the invasive treatment of obstructive coronary artery disease by reducing both, restenosis rate and need for reinterventions. This success resulted in a widespread utilization of DES in clinical practice and entailed many clinical research

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.

Strengthening public health research for improved health

Directory of Open Access Journals (Sweden)

Enrique Gea-Izquierdo

2012-08-01

Full Text Available Research in public health is a range that includes from fundamental research to research in clinical practice, including novel advances, evaluation of results and their spreading. Actually, public health research is considered multidisciplinary incorporating numerous factors in its development. Establishing as a mainstay the scientific method, deepens in basic research, clinical epidemiological research and health services. The premise of quality and relevance is reflected in international scientific research, and in the daily work and good biomedical practices that should be included in the research as a common task. Therefore, the research must take a proactive stance of inquiry, integrating a concern planned and ongoing development of knowledge. This requires improve international coordination, seeking a balance between basic and applied research as well as science and technology. Thus research cannot be considered without innovation, weighing up the people and society needs. Acting on knowledge of scientific production processes requires greater procedures thoroughness and the effective expression of the results. It is noted as essential to establish explicit principles in review and evaluation of the adjustments of actions, always within the standards of scientific conduct and fairness of the research process. In the biomedical scientific lines it have to be consider general assessments that occur related to the impact and quality of health research, mostly leading efforts to areas that require further attention. However, other subject areas that may be deficient or with lower incidence in the population should not be overlook. Health research as a source of new applications and development provides knowledge, improving well-being. However, it is understandable without considering the needs and social demands. Therefore, in public health research and to improve the health of the population, we must refine and optimize the prevention and

Needs assessment for collaborative network in pediatric clinical research and education.

Science.gov (United States)

Ishiguro, Akira; Sasaki, Hatoko; Yahagi, Naohisa; Kato, Hitoshi; Kure, Shigeo; Mori, Rintaro

2017-01-01

A collaborative network for pediatric research has not been fully established in Japan. To identify the network infrastructure, we conducted a survey on the support and education for clinical research currently available in children's hospitals. In November 2014, a 27-question survey was distributed to 31 hospitals belonging to the Japanese Association of Children's Hospitals and Related Institutions (JACHRI) to assess clinical research support, research education, research achievements, and their expectations. All the hospitals responded to the survey. Overall, 74.2% of hospitals had clinical research support divisions. Although all hospitals had ethics committees, manager, intellectual property management unit, biostatistician, and English-language editor. Seven hospitals had education programs for clinical research. The number of seminars and workshops for clinical research had significant correlations with the number of physicians (r = 0.927), pediatricians (r = 0.922), and clinical trial management physicians (r = 0.962). There was a significant difference in the number of clinical trials initiated by physicians between hospitals with research education programs and those without (P leader to establish a collaborative network for clinical research. Important factors for creating a collaborative system for pediatric research in Japan were identified. Human resources to support clinical research are a key factor to improve clinical research education and research achievements. © 2016 Japan Pediatric Society.

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.

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.

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.

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.

Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries.

Science.gov (United States)

Denburg, Avram; Rodriguez-Galindo, Carlos; Joffe, Steven

2016-06-01

Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a "trial effect," however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure-the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research-may function as a quality improvement lever, improving the quality of care and outcomes of all patients within an institution or region independent of their individual participation in trials. We further contend that this "infrastructure effect" can yield particular benefits for patients in low- and middle-income countries (LMICs). The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development.

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

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.

Designing a Clinical Data Warehouse Architecture to Support Quality Improvement Initiatives.

Science.gov (United States)

Chelico, John D; Wilcox, Adam B; Vawdrey, David K; Kuperman, Gilad J

2016-01-01

Clinical data warehouses, initially directed towards clinical research or financial analyses, are evolving to support quality improvement efforts, and must now address the quality improvement life cycle. In addition, data that are needed for quality improvement often do not reside in a single database, requiring easier methods to query data across multiple disparate sources. We created a virtual data warehouse at NewYork Presbyterian Hospital that allowed us to bring together data from several source systems throughout the organization. We also created a framework to match the maturity of a data request in the quality improvement life cycle to proper tools needed for each request. As projects progress in the Define, Measure, Analyze, Improve, Control stages of quality improvement, there is a proper matching of resources the data needs at each step. We describe the analysis and design creating a robust model for applying clinical data warehousing to quality improvement.

Improving clinical research and cancer care delivery in community settings: evaluating the NCI community cancer centers program.

Science.gov (United States)

Clauser, Steven B; Johnson, Maureen R; O'Brien, Donna M; Beveridge, Joy M; Fennell, Mary L; Kaluzny, Arnold D

2009-09-26

In this article, we describe the National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) pilot and the evaluation designed to assess its role, function, and relevance to the NCI's research mission. In doing so, we describe the evolution of and rationale for the NCCCP concept, participating sites' characteristics, its multi-faceted aims to enhance clinical research and quality of care in community settings, and the role of strategic partnerships, both within and outside of the NCCCP network, in achieving program objectives. The evaluation of the NCCCP is conceptualized as a mixed method multi-layered assessment of organizational innovation and performance which includes mapping the evolution of site development as a means of understanding the inter- and intra-organizational change in the pilot, and the application of specific evaluation metrics for assessing the implementation, operations, and performance of the NCCCP pilot. The assessment of the cost of the pilot as an additional means of informing the longer-term feasibility and sustainability of the program is also discussed. The NCCCP is a major systems-level set of organizational innovations to enhance clinical research and care delivery in diverse communities across the United States. Assessment of the extent to which the program achieves its aims will depend on a full understanding of how individual, organizational, and environmental factors align (or fail to align) to achieve these improvements, and at what cost.

Parent Refusal of Topical Fluoride for Their Children: Clinical Strategies and Future Research Priorities to Improve Evidence-Based Pediatric Dental Practice.

Science.gov (United States)

Chi, Donald L

2017-07-01

A growing number of parents are refusing topical fluoride for their children during preventive dental and medical visits. This nascent clinical and public health problem warrants attention from dental professionals and the scientific community. Clinical and community-based strategies are available to improve fluoride-related communications with parents and the public. In terms of future research priorities, there is a need to develop screening tools to identify parents who are likely to refuse topical fluoride and diagnostic instruments to uncover the reasons for topical fluoride refusal. This knowledge will lead to evidence-based strategies that can be widely disseminated into clinical practice. Copyright © 2017 Elsevier Inc. All rights reserved.

Semantic processing of EHR data for clinical research.

Science.gov (United States)

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

2015-12-01

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

Use of a data warehouse at an academic medical center for clinical pathology quality improvement, education, and research.

Science.gov (United States)

Krasowski, Matthew D; Schriever, Andy; Mathur, Gagan; Blau, John L; Stauffer, Stephanie L; Ford, Bradley A

2015-01-01

Pathology data contained within the electronic health record (EHR), and laboratory information system (LIS) of hospitals represents a potentially powerful resource to improve clinical care. However, existing reporting tools within commercial EHR and LIS software may not be able to efficiently and rapidly mine data for quality improvement and research applications. We present experience using a data warehouse produced collaboratively between an academic medical center and a private company. The data warehouse contains data from the EHR, LIS, admission/discharge/transfer system, and billing records and can be accessed using a self-service data access tool known as Starmaker. The Starmaker software allows users to use complex Boolean logic, include and exclude rules, unit conversion and reference scaling, and value aggregation using a straightforward visual interface. More complex queries can be achieved by users with experience with Structured Query Language. Queries can use biomedical ontologies such as Logical Observation Identifiers Names and Codes and Systematized Nomenclature of Medicine. We present examples of successful searches using Starmaker, falling mostly in the realm of microbiology and clinical chemistry/toxicology. The searches were ones that were either very difficult or basically infeasible using reporting tools within the EHR and LIS used in the medical center. One of the main strengths of Starmaker searches is rapid results, with typical searches covering 5 years taking only 1-2 min. A "Run Count" feature quickly outputs the number of cases meeting criteria, allowing for refinement of searches before downloading patient-identifiable data. The Starmaker tool is available to pathology residents and fellows, with some using this tool for quality improvement and scholarly projects. A data warehouse has significant potential for improving utilization of clinical pathology testing. Software that can access data warehouse using a straightforward visual

Use of a data warehouse at an academic medical center for clinical pathology quality improvement, education, and research

Directory of Open Access Journals (Sweden)

Matthew D Krasowski

2015-01-01

Full Text Available Background: Pathology data contained within the electronic health record (EHR, and laboratory information system (LIS of hospitals represents a potentially powerful resource to improve clinical care. However, existing reporting tools within commercial EHR and LIS software may not be able to efficiently and rapidly mine data for quality improvement and research applications. Materials and Methods: We present experience using a data warehouse produced collaboratively between an academic medical center and a private company. The data warehouse contains data from the EHR, LIS, admission/discharge/transfer system, and billing records and can be accessed using a self-service data access tool known as Starmaker. The Starmaker software allows users to use complex Boolean logic, include and exclude rules, unit conversion and reference scaling, and value aggregation using a straightforward visual interface. More complex queries can be achieved by users with experience with Structured Query Language. Queries can use biomedical ontologies such as Logical Observation Identifiers Names and Codes and Systematized Nomenclature of Medicine. Result: We present examples of successful searches using Starmaker, falling mostly in the realm of microbiology and clinical chemistry/toxicology. The searches were ones that were either very difficult or basically infeasible using reporting tools within the EHR and LIS used in the medical center. One of the main strengths of Starmaker searches is rapid results, with typical searches covering 5 years taking only 1-2 min. A "Run Count" feature quickly outputs the number of cases meeting criteria, allowing for refinement of searches before downloading patient-identifiable data. The Starmaker tool is available to pathology residents and fellows, with some using this tool for quality improvement and scholarly projects. Conclusion: A data warehouse has significant potential for improving utilization of clinical pathology testing

Does quality improvement work in neonatology improve clinical outcomes?

Science.gov (United States)

Ellsbury, Dan L; Clark, Reese H

2017-04-01

Quality improvement initiatives in neonatology have been promoted as an important way of improving outcomes of newborns. The purpose of this review is to examine the effectiveness of recent quality improvement work in improving the outcomes of infants requiring neonatal intensive care. Quality improvement collaboratives and single-center projects demonstrate improvement of clinical processes and outcomes in neonatology that impact both preterm and term infants. Declines in morbidities, resource use, and length of stay have been associated with reductions in healthcare costs. Recent quality improvement work has shown evidence of improvement in clinical outcomes in neonatal intensive care patients. These improvements have important implications for the reduction of healthcare costs in this population.

Do clinical safety charts improve paramedic key performance indicator results? (A clinical improvement programme evaluation).

Science.gov (United States)

Ebbs, Phillip; Middleton, Paul M; Bonner, Ann; Loudfoot, Allan; Elliott, Peter

2012-07-01

Is the Clinical Safety Chart clinical improvement programme (CIP) effective at improving paramedic key performance indicator (KPI) results within the Ambulance Service of New South Wales? The CIP intervention area was compared with the non-intervention area in order to determine whether there was a statistically significant improvement in KPI results. The CIP was associated with a statistically significant improvement in paramedic KPI results within the intervention area. The strategies used within this CIP are recommended for further consideration.

[Introduction of a Clinical Research Experience Program in Hospital Practical Training for Pharmacy Students and Its Evaluation].

Science.gov (United States)

Takahashi, Katsuyuki; Suda, Yasuki; Kawaguchi, Hiroshi; Nakamura, Yasutaka; Kawabata, Shiho; Kawakami, Noriko; Nishikawa, Takeshi; Nagayama, Katsuya

2015-01-01

Long-term clinical training based on a model core curriculum was conducted to nurture highly competent pharmacists in the clinical field. Pharmacists' responsibilities are expanding, and a system has been developed to help pharmacists gain accreditation, identify specialties, and improve their training. However, this system requires research competency. Therefore clinical research should be considered a part of clinical training to encourage high competency among pharmacists. Because the model core curriculum does not include a section on clinical research. Osaka City University Hospital introduced a hands-on clinical research experience program and evaluated its usefulness. A significant improvement in the level of knowledge and awareness of clinical research was seen among students who underwent the clinical research experience program. In addition, the level of student satisfaction was higher. These findings suggest that a clinical research experience program may be useful to nurture a greater awareness of clinical research and knowledge acquisition among pharmacists.

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

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.

Improving clinical research and cancer care delivery in community settings: evaluating the NCI community cancer centers program

Directory of Open Access Journals (Sweden)

Fennell Mary L

2009-09-01

Full Text Available Abstract Background In this article, we describe the National Cancer Institute (NCI Community Cancer Centers Program (NCCCP pilot and the evaluation designed to assess its role, function, and relevance to the NCI's research mission. In doing so, we describe the evolution of and rationale for the NCCCP concept, participating sites' characteristics, its multi-faceted aims to enhance clinical research and quality of care in community settings, and the role of strategic partnerships, both within and outside of the NCCCP network, in achieving program objectives. Discussion The evaluation of the NCCCP is conceptualized as a mixed method multi-layered assessment of organizational innovation and performance which includes mapping the evolution of site development as a means of understanding the inter- and intra-organizational change in the pilot, and the application of specific evaluation metrics for assessing the implementation, operations, and performance of the NCCCP pilot. The assessment of the cost of the pilot as an additional means of informing the longer-term feasibility and sustainability of the program is also discussed. Summary The NCCCP is a major systems-level set of organizational innovations to enhance clinical research and care delivery in diverse communities across the United States. Assessment of the extent to which the program achieves its aims will depend on a full understanding of how individual, organizational, and environmental factors align (or fail to align to achieve these improvements, and at what cost.

Translational Environmental Research: Improving the Usefulness and Usability of Research Results

Science.gov (United States)

Garfin, G.

2008-12-01

In recent years, requests for proposals more frequently emphasize outreach to stakeholder communities, decision support, and science that serves societal needs. Reports from the National Academy of Sciences and Western States Water Council emphasize the need for science translation and outreach, in order to address societal concerns with climate extremes, such as drought, the use of climate predictions, and the growing challenges of climate change. In the 1990s, the NOAA Climate Program Office developed its Regional Integrated Sciences and Asssessments program to help bridge the gap between climate science (notably, seasonal predictions) and society, to improve the flow of information to stakeholders, and to increase the relevance of climate science to inform decisions. During the same time period, the National Science Foundation initiated multi-year Science and Technology Centers and Decision Making Under Uncertainty Centers, with similar goals, but different metrics of success. Moreover, the combination of population growth, climate change, and environmental degradation has prompted numerous research initiatives on linking knowledge and action for sustainable development. This presentation reviews various models and methodologies for translating science results from field, lab, or modeling work to use by society. Lessons and approaches from cooperative extension, boundary organizations, co-production of science and policy, and medical translational research are examined. In particular, multi-step translation as practiced within the health care community is examined. For example, so- called "T1" (translation 1) research moves insights from basic science to clinical research; T2 research evaluates the effectiveness of clinical practice, who benefits from promising care regimens, and develops tools for clinicians, patients, and policy makers. T3 activities test the implementation, delivery, and spread of research results and clinical practices in order to foster

Innovative designs for radiation oncology research in clinical trials

International Nuclear Information System (INIS)

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

1987-01-01

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

Satisfaction and improvement of clinical experiment of student radiotechnologists

International Nuclear Information System (INIS)

Lyu, Kwang Yeul; Kim, Hyun Soo

2006-01-01

Clinical experiment is a set of experience to help student acquire technic, attitude and knowledge by participating in the clinical work. The radiotechnologists who are employed in departments of radiology serve as clinical instructors. Their responsibilities include teaching students them to become competent radiotechnologist. Clinical instructors often have no formal preparation in teaching student. The purpose of this study is to review some principals that will help clinical instructors support and foster the professional development of student radiotechnologists. The clinical instructor should be able to identify the qualities of instructor, the characteristics of feedback and use facilitation skills when is evaluated student performance. And the survey was performed to evaluate the satisfaction of student participated in clinical experiment, the purpose of this research is to fine the problems and improvements in clinical experiment of student radiotechnologist in Korea

The need for patient-centred clinical research in idiopathic pulmonary fibrosis.

Science.gov (United States)

Russell, Anne-Marie; Sprangers, Mirjam A G; Wibberley, Steven; Snell, Noel; Rose, Daniel M; Swigris, Jeff J

2015-09-24

Patient-centredness is an accepted term and is perceived by healthcare professionals to be morally and ethically desirable. We are motivated by the belief that this approach will improve the patient-professional experience of the decision-making process and improve health outcomes. We acknowledge that patients, either as participants or as co-investigators, have positive contributions to make to research. As the idiopathic pulmonary fibrosis (IPF) community enters a new era of clinical research activity we consider that there is greater capacity for patient involvement and partnership.Patient involvement in research can be optimised through collaborations in the research design, study conduct, and dissemination. There is increasing interest in using patient- reported outcomes (PROs), such as health-related quality of life, and symptoms measures to inform decision-making and ensure patient perspectives are taken into account. PROs are an essential component of specialist IPF services, to monitor and improve care delivery and to measure and benchmark performance. In clinical trials, PROs can additionally be used to define entry criteria, evaluate efficacy of an intervention, and evaluate adverse events. We suggest that there is a much wider scope for including patient-centred PROs in clinical research and for creative thought in developing patient co-investigator roles.Participation in research activity requires highly refined decision-making processes, particularly in a condition such as IPF, which has an often unpredictable trajectory. The IPF research landscape has changed and the design and conduct of clinical trials in IPF requires some radical rethinking. It is accepted that involving patients in the role of co-investigators will impact the research questions we ask and result in study designs that are patient-centred. IPF clinical trials have been hindered by the lack of availability of validated, disease-specific questionnaires. A conservative approach

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

[How can institutional structures make clinical research in France more operational?].

Science.gov (United States)

Funck-Brentano, C; Brouard, R

The laws regulating the practice of clinical research in France, in particular the law of 20 December 1988, the so-called Huriet's law, constitute a major advance for medical progress. However, their implementation by administrative offices generates practical difficulties which impair the development of applied research in human beings. Beyond the laws themselves, it appears that our institutions are unprepared to optimize the conduct of such research. This round table sought to list the existing problems and to propose constructive solutions or objectives to be reached to optimize clinical research in France, with a view to improving French participation in international collaborative programmes, notably European ones. Evaluation of projects and practices, financial support and accounting, and some aspects of existing laws have been identified as the major sources of our difficulties. Harmonization and clarification of our procedures as well as improvement of training should be our primary objectives to achieve a higher level of medical, scientific, financial and administrative quality in the conduct of clinical research. Creation of a referential Web site, designed and updated by a central public organization, is an imperative step towards reaching these objectives.

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.

Improved quality monitoring of multi-center acupuncture clinical trials in China

Directory of Open Access Journals (Sweden)

Zheng Hui

2009-12-01

Full Text Available Abstract Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs. Methods A standard quality control program (QCP was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.

Conceptual framework for behavioral and social science in HIV vaccine clinical research.

Science.gov (United States)

Lau, Chuen-Yen; Swann, Edith M; Singh, Sagri; Kafaar, Zuhayr; Meissner, Helen I; Stansbury, James P

2011-10-13

HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance. Published by Elsevier Ltd.

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.

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.

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.

Legacy Clinical Data from the Mission Connect Mild TBI Translational Research Consortium

Science.gov (United States)

2017-10-01

AWARD NUMBER: W81XWH-16-2-0026 TITLE: Legacy Clinical Data from the Mission Connect Mild TBI Translational Research Consortium PRINCIPAL...2017 4. TITLE AND SUBTITLE Legacy Clinical Data from the Mission Connect Mild TBI Translational Research 5a. CONTRACT NUMBER Consortium 5b. GRANT...mTBI) Translational Research Consortium was to improve the diagnosis and treatment of mTBI. We enrolled a total of 88 mTBI patients and 73 orthopedic

Better Outcomes through Learning, Data, Engagement, and Research (BOLDER – a system for improving evidence and clinical practice in low and middle income countries [version 1; referees: 2 approved

Directory of Open Access Journals (Sweden)

BOLDER Research Group

2016-04-01

Full Text Available Despite the many thousands of research studies published every year, evidence for making clinical decisions is often lacking. The main problem is that the evidence available is generated in conditions very different from those that prevail in routine clinical practice and with patients who are different. This is particularly a problem for low and middle income countries as most evidence is generated in high income countries. A group of clinicians, researchers, and policy makers met at Bellagio in Italy to consider how more relevant evidence might be generated. One answer is to conduct more pragmatic trials—those undertaken in routine clinical practice. The group thought that this might best be achieved by developing “learning health systems” in low and middle income countries. Learning health systems develop in communities that include clinicians, patients, researchers, improvement specialists, information technology specialists, managers, and policy makers and have a governance system that gives a voice to all those in the community. The systems focus on improving outcomes for patients, use a common dataset, and promote quality improvement and pragmatic research. Plans have been developed to create at least two learning systems in Africa.

Tuberculous meningitis: a uniform case definition for use in clinical research.

Science.gov (United States)

Marais, Suzaan; Thwaites, Guy; Schoeman, Johan F; Török, M Estée; Misra, Usha K; Prasad, Kameshwar; Donald, Peter R; Wilkinson, Robert J; Marais, Ben J

2010-11-01

Tuberculous meningitis causes substantial mortality and morbidity in children and adults. More research is urgently needed to better understand the pathogenesis of disease and to improve its clinical management and outcome. A major stumbling block is the absence of standardised diagnostic criteria. The different case definitions used in various studies makes comparison of research findings difficult, prevents the best use of existing data, and limits the management of disease. To address this problem, a 3-day tuberculous meningitis workshop took place in Cape Town, South Africa, and was attended by 41 international participants experienced in the research or management of tuberculous meningitis. During the meeting, diagnostic criteria were assessed and discussed, after which a writing committee was appointed to finalise a consensus case definition for tuberculous meningitis for use in future clinical research. We present the consensus case definition together with the rationale behind the recommendations. This case definition is applicable irrespective of the patient's age, HIV infection status, or the resources available in the research setting. Consistent use of the proposed case definition will aid comparison of studies, improve scientific communication, and ultimately improve care. Copyright © 2010 Elsevier Ltd. All rights reserved.

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

MO-C-BRB-00: President’s Symposium: Revitalizing Scientific Excellence: Turning Research Into Clinical Reality Through Translational Research

International Nuclear Information System (INIS)

2015-01-01

Diagnostic radiology and radiation oncology are arguably two of the most technologically advanced specialties in medicine. The imaging and radiation medicine technologies in clinical use today have been continuously improved through new advances made in the commercial and academic research arenas. This symposium explores the translational path from research through clinical implementation. Dr. Pettigrew will start this discussion by sharing his perspectives as director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The NIBIB has focused on promoting research that is technological in nature and has high clinical impact. We are in the age of precision medicine, and the technological innovations and quantitative tools developed by engineers and physicists working with physicians are providing innovative tools that increase precision and improve outcomes in health care. NIBIB funded grants lead to a very high patenting rate (per grant dollar), and these patents have higher citation rates by other patents, suggesting greater clinical impact, as well. Two examples of clinical translation resulting from NIH-funded research will be presented, in radiation therapy and diagnostic imaging. Dr. Yu will describe a stereotactic radiotherapy device developed in his laboratory that is designed for treating breast cancer with the patient in the prone position. It uses 36 rotating Cobalt-60 sources positioned in an annular geometry to focus the radiation beam at the system’s isocenter. The radiation dose is delivered throughout the target volume in the breast by constantly moving the patient in a planned trajectory relative to the fixed isocenter. With this technique, the focal spot dynamically paints the dose distribution throughout the target volume in three dimensions. Dr. Jackson will conclude this symposium by describing the RSNA Quantitative Imaging Biomarkers Alliance (QIBA), which is funded in part by NIBIB and is a synergistic collaboration

MO-C-BRB-00: President’s Symposium: Revitalizing Scientific Excellence: Turning Research Into Clinical Reality Through Translational Research

Energy Technology Data Exchange (ETDEWEB)

NONE

2015-06-15

Diagnostic radiology and radiation oncology are arguably two of the most technologically advanced specialties in medicine. The imaging and radiation medicine technologies in clinical use today have been continuously improved through new advances made in the commercial and academic research arenas. This symposium explores the translational path from research through clinical implementation. Dr. Pettigrew will start this discussion by sharing his perspectives as director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The NIBIB has focused on promoting research that is technological in nature and has high clinical impact. We are in the age of precision medicine, and the technological innovations and quantitative tools developed by engineers and physicists working with physicians are providing innovative tools that increase precision and improve outcomes in health care. NIBIB funded grants lead to a very high patenting rate (per grant dollar), and these patents have higher citation rates by other patents, suggesting greater clinical impact, as well. Two examples of clinical translation resulting from NIH-funded research will be presented, in radiation therapy and diagnostic imaging. Dr. Yu will describe a stereotactic radiotherapy device developed in his laboratory that is designed for treating breast cancer with the patient in the prone position. It uses 36 rotating Cobalt-60 sources positioned in an annular geometry to focus the radiation beam at the system’s isocenter. The radiation dose is delivered throughout the target volume in the breast by constantly moving the patient in a planned trajectory relative to the fixed isocenter. With this technique, the focal spot dynamically paints the dose distribution throughout the target volume in three dimensions. Dr. Jackson will conclude this symposium by describing the RSNA Quantitative Imaging Biomarkers Alliance (QIBA), which is funded in part by NIBIB and is a synergistic collaboration

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.

Nurse awareness of clinical research: a survey in a Japanese University Hospital

Science.gov (United States)

2014-01-01

Background Clinical research plays an important role in establishing new treatments and improving the quality of medical practice. Since the introduction of the concept of clinical research coordinators (CRC) in Japan, investigators and CRC work as a clinical research team that coordinates with other professionals in clinical trials leading to drug approval (registration trials). Although clinical nurses collaborate with clinical research teams, extended clinical research teams that include clinical nurses may contribute to the ethical and scientific pursuit of clinical research. Methods As knowledge of clinical research is essential for establishing an extended clinical research team, we used questionnaires to survey the knowledge of clinical nurses at Tokushima University Hospital. Five-point and two-point scales were used. Questions as for various experiences were also included and the relationship between awareness and experiences were analyzed. Results Among the 597 nurses at Tokushima University Hospital, 453 (75.9%) responded to the questionnaires. In Japan, registration trials are regulated by pharmaceutical affairs laws, whereas other types of investigator-initiated research (clinical research) are conducted based on ethical guidelines outlined by the ministries of Japan. Approximately 90% of respondents were aware of registration trials and clinical research, but less than 40% of the nurses were aware of their difference. In clinical research terminology, most respondents were aware of informed consent and related issues, but ≤50% were aware of other things, such as the Declaration of Helsinki, ethical guidelines, Good Clinical Practice, institutional review boards, and ethics committees. We found no specific tendency in the relationship between awareness and past experiences, such as nursing patients who were participating in registration trials and/or clinical research or taking a part in research involving patients as a nursing student or a nurse

An Integrated Workflow For Secondary Use of Patient Data for Clinical Research.

Science.gov (United States)

Bouzillé, Guillaume; Sylvestre, Emmanuelle; Campillo-Gimenez, Boris; Renault, Eric; Ledieu, Thibault; Delamarre, Denis; Cuggia, Marc

2015-01-01

This work proposes an integrated workflow for secondary use of medical data to serve feasibility studies, and the prescreening and monitoring of research studies. All research issues are initially addressed by the Clinical Research Office through a research portal and subsequently redirected to relevant experts in the determined field of concentration. For secondary use of data, the workflow is then based on the clinical data warehouse of the hospital. A datamart with potentially eligible research candidates is constructed. Datamarts can either produce aggregated data, de-identified data, or identified data, according to the kind of study being treated. In conclusion, integrating the secondary use of data process into a general research workflow allows visibility of information technologies and improves the accessability of clinical data.

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.

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

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.

Feasibility of encoding the Institute for Clinical Systems Improvement Depression Guideline using the Omaha System.

Science.gov (United States)

Monsen, Karen A; Neely, Claire; Oftedahl, Gary; Kerr, Madeleine J; Pietruszewski, Pam; Farri, Oladimeji

2012-08-01

Evidence-based clinical guidelines are being developed to bridge the gap between research and practice with the goals of improving health care quality and population health. However, disseminating, implementing, and ensuring ongoing use of clinical guidelines in practice settings is challenging. The purpose of this study was to demonstrate the feasibility of encoding evidence-based clinical guidelines using the Omaha System. Clinical documentation with Omaha System-encoded guidelines generates individualized, meaningful data suitable for program evaluation and health care quality research. The use of encoded guidelines within the electronic health record has potential to reinforce use of guidelines, and thus improve health care quality and population health. Research using Omaha System data generated by clinicians has potential to discover new knowledge related to guideline use and effectiveness. Copyright © 2012 Elsevier Inc. All rights reserved.

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.

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

[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.

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 ...

Is mindfulness research methodology improving over time? A systematic review.

Directory of Open Access Journals (Sweden)

Simon B Goldberg

Full Text Available Despite an exponential growth in research on mindfulness-based interventions, the body of scientific evidence supporting these treatments has been criticized for being of poor methodological quality.The current systematic review examined the extent to which mindfulness research demonstrated increased rigor over the past 16 years regarding six methodological features that have been highlighted as areas for improvement. These feature included using active control conditions, larger sample sizes, longer follow-up assessment, treatment fidelity assessment, and reporting of instructor training and intent-to-treat (ITT analyses.We searched PubMed, PsychInfo, Scopus, and Web of Science in addition to a publically available repository of mindfulness studies.Randomized clinical trials of mindfulness-based interventions for samples with a clinical disorder or elevated symptoms of a clinical disorder listed on the American Psychological Association's list of disorders with recognized evidence-based treatment.Independent raters screened 9,067 titles and abstracts, with 303 full text reviews. Of these, 171 were included, representing 142 non-overlapping samples.Across the 142 studies published between 2000 and 2016, there was no evidence for increases in any study quality indicator, although changes were generally in the direction of improved quality. When restricting the sample to those conducted in Europe and North America (continents with the longest history of scientific research in this area, an increase in reporting of ITT analyses was found. When excluding an early, high-quality study, improvements were seen in sample size, treatment fidelity assessment, and reporting of ITT analyses.Taken together, the findings suggest modest adoption of the recommendations for methodological improvement voiced repeatedly in the literature. Possible explanations for this and implications for interpreting this body of research and conducting future studies are

The role of Clinical Trial Units in investigator- and industry-initiated research projects.

Science.gov (United States)

von Niederhäusern, Belinda; Fabbro, Thomas; Pauli-Magnus, Christiane

2015-01-01

Six multidisciplinary competence centres (Clinical Trial Units, CTUs) in Basel, Berne, Geneva, Lausanne, St. Gallen and Zurich provide professional support to clinical researchers in the planning, implementation, conduct and evaluation of clinical studies. Through their coordinated network, these units promote high-quality, nationally harmonised and internationally standardised clinical research conduct in Switzerland. We will describe why this network has been established, how it has been successful in stilling the growing need for clinical research support, which training and education opportunities it offers, and how it created national awareness for the still-existing hurdles towards clinical research excellence in Switzerland. Taking the CTU Basel as an example, we show that a considerable number (25%) of the studies submitted for regulatory approval in 2013 were supported by the CTU, decreasing the number of findings in ethics reviews by about one-third. We conclude that these achievements, together with a Swiss national funding model for clinical research, and improved national coordination, will be critical factors to successfully position Swiss clinical research at the international forefront.

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...

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

DEFF Research Database (Denmark)

Bøttcher Berthelsen, Connie; Hølge-Hazelton, Bibi

2017-01-01

for efficiency, nurses’ barriers to research use and the lack of definition of the concept of nursing research culture make it difficult to establish. Design Concept analysis. Data sources Data were collected through a literature review in PubMed, CINAHL and PsycINFO during March 2016. Methods Walker and Avant......Aim To report an analysis of the concept of nursing research culture in the context of clinical nursing practice. Background Nursing research culture should be valued for its contribution to improving patient care and should be considered as a routine hospital activity. However, the demand......'s eight-step framework for concept analysis. Results Five defining attributes of nursing research culture in the context of clinical nursing practice were identified: strong monodisciplinary nursing professionalism, academic thinking and socialization, research use as a part of daily nursing practice...

Instructional scaffolding to improve students' skills in evaluating clinical literature.

Science.gov (United States)

Dawn, Stefani; Dominguez, Karen D; Troutman, William G; Bond, Rucha; Cone, Catherine

2011-05-10

To implement and assess the effectiveness of an activity to teach pharmacy students to critically evaluate clinical literature using instructional scaffolding and a Clinical Trial Evaluation Rubric. The literature evaluation activity centered on a single clinical research article and involved individual, small group, and large group instruction, with carefully structured, evidence-based scaffolds and support materials centered around 3 educational themes: (1) the reader's awareness of text organization, (2) contextual/background information and vocabulary, and (3) questioning, prompting, and self-monitoring (metacognition). Students initially read the article, scored it using the rubric, and wrote an evaluation. Students then worked individually using a worksheet to identify and define 4 to 5 vocabulary/concept knowledge gaps. They then worked in small groups and as a class to further improve their skills. Finally, they assessed the same article using the rubric and writing a second evaluation. Students' rubric scores for the article decreased significantly from a mean pre-activity score of 76.7% to a post-activity score of 61.7%, indicating that their skills in identifying weaknesses in the article's study design had improved. Use of instructional scaffolding in the form of vocabulary supports and the Clinical Trial Evaluation Rubric improved students' ability to critically evaluate a clinical study compared to lecture-based coursework alone.

How to design and write a clinical research protocol in Cosmetic Dermatology*

Science.gov (United States)

Bagatin, Ediléia; Miot, Helio A.

2013-01-01

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

Regulatory Framework for Conducting Clinical Research in Canada.

Science.gov (United States)

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

2017-09-01

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

Improving Clinical Trial Cohort Definition Criteria and Enrollment with Distributional Semantic Matching

OpenAIRE

Shao, Jianyin; Gouripeddi, Ramkiran; Facelli, Julio C.

2016-01-01

Shao, J., Gouripeddi, R., & Facelli, J.C. (2016). Improving Clinical Trial Cohort Definition Criteria and Enrollment with Distributional Semantic Matching (poster). Research Reproducibility 2016. Salt Lake City, UT, USA

["Practical clinical competence" - a joint programme to improve training in surgery].

Science.gov (United States)

Ruesseler, M; Schill, A; Stibane, T; Damanakis, A; Schleicher, I; Menzler, S; Braunbeck, A; Walcher, F

2013-12-01

Practical clinical competence is, as a result of the complexity of the required skills and the immediate consequences of their insufficient mastery, fundamentally important for undergraduate medical education. However, in the daily clinical routine, undergraduate training competes with patient care and experimental research, mostly to the disadvantage of the training of clinical skills and competencies. All students have to spend long periods in compulsory surgical training courses during their undergraduate studies. Thus, surgical undergraduate training is predestined to exemplarily develop, analyse and implement a training concept comprising defined learning objectives, elaborated teaching materials, analysed teaching methods, as well as objective and reliable assessment methods. The aim of this project is to improve and strengthen undergraduate training in practical clinical skills and competencies. The project is funded by the German Federal Ministry of Education and Research with almost two million Euro as a joint research project of the medical faculties of the universities of Frankfurt/Main, Gießen and Marburg, in collaboration with the German Society of Surgery, the German Society of Medical Education and the German Medical Students' Association. Nine packages in three pillars are combined in order to improve undergraduate medical training on a methodical, didactic and curricular level in a nation-wide network. Each partner of this network provides a systematic contribution to the project based on individual experience and competence. Based on the learning objectives, which were defined by the working group "Education" of the German Society of Surgery, teaching contents will be analysed with respect to their quality and will be available for both teachers and students as mobile learning tool (first pillar). The existing surgical curricula at the cooperating medical faculties will be analysed and teaching methods as well as assessment methods for clinical

The STAR Data Reporting Guidelines for Clinical High Altitude Research.

Science.gov (United States)

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

2018-03-01

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

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.

Do Clinical Practice Guidelines Improve Quality?

Science.gov (United States)

Baldassari, Cristina M

2017-07-01

Controversy exists surrounding how to best define and assess quality in the health care setting. Clinical practice guidelines (CPGs) have been developed to improve the quality of medical care by highlighting key clinical recommendations based on recent evidence. However, data linking CPGs to improvements in outcomes in otolaryngology are lacking. Numerous barriers contribute to difficulties in translating CPGs to improvements in quality. Future initiatives are needed to improve CPG adherence and define the impact of CPG recommendations on the quality of otolaryngologic care provided to our patients.

Effective interventions on service quality improvement in a physiotherapy clinic.

Science.gov (United States)

Gharibi, Farid; Tabrizi, JafarSadegh; Eteraf Oskouei, MirAli; AsghariJafarabadi, Mohammad

2014-01-01

Service quality is considered as a main domain of quality associ-ated with non-clinical aspect of healthcare. This study aimed to survey and im-proves service quality of delivered care in the Physiotherapy Clinic affiliated with the Tabriz University of Medical Sciences, Tabriz, Iran. A quasi experimental interventional study was conducted in the Physiotherapy Clinic, 2010-2011. Data were collected using a validated and reli-able researcher made questionnaire with participation of 324 patients and their coadjutors. The study questionnaire consisted of 7 questions about demographic factors and 38 questions for eleven aspects of service quality. Data were then analyzed using paired samples t-test by SPSS16. In the pre intervention phase, six aspects of service quality including choice of provider, safety, prevention and early detection, dignity, autonomy and availability achieved non-acceptable scores. Following interventions, all aspects of the service quality improved and also total service quality score improved from 8.58 to 9.83 (PService quality can be improved by problem implementation of appropriate interventions. The acquired results can be used in health system fields to create respectful environments for healthcare customers.

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.

Detecting dissonance in clinical and research workflow for translational psychiatric registries.

Science.gov (United States)

Cofiel, Luciana; Bassi, Débora U; Ray, Ryan Kumar; Pietrobon, Ricardo; Brentani, Helena

2013-01-01

The interplay between the workflow for clinical tasks and research data collection is often overlooked, ultimately making it ineffective. To the best of our knowledge, no previous studies have developed standards that allow for the comparison of workflow models derived from clinical and research tasks toward the improvement of data collection processes. In this study we used the term dissonance for the occurrences where there was a discord between clinical and research workflows. We developed workflow models for a translational research study in psychiatry and the clinic where its data collection was carried out. After identifying points of dissonance between clinical and research models we derived a corresponding classification system that ultimately enabled us to re-engineer the data collection workflow. We considered (1) the number of patients approached for enrollment and (2) the number of patients enrolled in the study as indicators of efficiency in research workflow. We also recorded the number of dissonances before and after the workflow modification. We identified 22 episodes of dissonance across 6 dissonance categories: actor, communication, information, artifact, time, and space. We were able to eliminate 18 episodes of dissonance and increase the number of patients approached and enrolled in research study trough workflow modification. The classification developed in this study is useful for guiding the identification of dissonances and reveal modifications required to align the workflow of data collection and the clinical setting. The methodology described in this study can be used by researchers to standardize data collection process.

A Data-driven Concept Schema for Defining Clinical Research Data Needs

Science.gov (United States)

Hruby, Gregory W.; Hoxha, Julia; Ravichandran, Praveen Chandar; Mendonça, Eneida A.; Hanauer, David A; Weng, Chunhua

2016-01-01

OBJECTIVES The Patient, Intervention, Control/Comparison, and Outcome (PICO) framework is an effective technique for framing a clinical question. We aim to develop the counterpart of PICO to structure clinical research data needs. METHODS We use a data-driven approach to abstracting key concepts representing clinical research data needs by adapting and extending an expert-derived framework originally developed for defining cancer research data needs. We annotated clinical trial eligibility criteria, EHR data request logs, and data queries to electronic health records (EHR), to extract and harmonize concept classes representing clinical research data needs. We evaluated the class coverage, class preservation from the original framework, schema generalizability, schema understandability, and schema structural correctness through a semi-structured interview with eight multidisciplinary domain experts. We iteratively refined the schema based on the evaluations. RESULTS Our data-driven schema preserved 68% of the 63 classes from the original framework and covered 88% (73/82) of the classes proposed by evaluators. Class coverage for participants of different backgrounds ranged from 60% to 100% with a median value of 95% agreement among the individual evaluators. The schema was found understandable and structurally sound. CONCLUSIONS Our proposed schema may serve as the counterpart to PICO for improving the research data needs communication between researchers and informaticians. PMID:27185504

[Clinical research outside of teaching hospitals: Current situation in north-eastern France].

Science.gov (United States)

Goetz, C; Dupoux, A; Déloy, L; Hertz, C; Jeanmaire, T; Parneix, N

2015-04-01

Most clinical research in France takes place in teaching hospitals. There are, however, many advantages to developing it in other hospitals: access to innovative treatments, improvement in healthcare quality, attractiveness of hospitals, increased trial inclusion rates and reduced selection bias. The objectives of our study were to report on the current situation of clinical research outside teaching hospitals. A three-stage survey was conducted between January 2012 and May 2013 in non-teaching hospitals of north-eastern France. First, questionnaires were sent to administrative and medical boards of all hospitals with more than 100 beds, then to head doctors of every department in hospitals with more than 300 beds and finally meetings were organized with members of 20 selected hospitals. The administrative and medical boards of 85 hospitals participated in the first stage of the survey; half of these hospitals were engaged in clinical research activities and for 10 the internal structuring was cross-disciplinary. Answers from 178 departments were obtained during the second stage; 47% reported a clinical research activity. Meetings with research teams in 20 hospitals allowed us to identify difficulties concerning research funding, transversal organization and sponsoring. Clinical research existed in more than half of the respondent non-teaching hospitals. Obstacles to its development can be grouped in three categories: 1) internal structuring of clinical research, 2) access to information and knowledge of how clinical research functions and to interlocutors outside the hospital and 3) access to skills necessary to sponsor clinical research. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

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.

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

An alternative path to improving university Earth science teaching and developing the geoscience workforce: Postdoctoral research faculty involvement in clinical teacher preparation

Science.gov (United States)

Zirakparvar, N. A.; Sessa, J.; Ustunisik, G. K.; Nadeau, P. A.; Flores, K. E.; Ebel, D. S.

2013-12-01

It is estimated that by the year 2020 relative to 2009, there will be 28% more Earth Science jobs paying ≥ $75,000/year1 in the U.S.A. These jobs will require advanced degrees, but compared to all arts and science advanced degrees, the number of physical science M.S. and Ph.D. awarded per year decreased from 2.5% in 1980 to 1.5% in 20092. This decline is reflected on a smaller scale and at a younger age: in the New York City school system only 36% of all 8th graders have basic proficiency in science 3. These figures indicate that the lack achievement in science starts at a young age and then extends into higher education. Research has shown that students in grades 7 - 12 4,5 and in university level courses 6 both respond positively to high quality science teaching. However, much attention is focused on improving science teaching in grades 7- 12, whereas at many universities lower level science courses are taught by junior research and contingent faculty who typically lack formal training, and sometimes interest, in effective teaching. The danger here is that students might enter university intending to pursue geoscience degrees, but then encounter ineffective instructors, causing them to lose interest in geoscience and thus pursue other disciplines. The crux of the matter becomes how to improve the quality of university-level geoscience teaching, without losing sight of the major benchmark of success for research faculty - scholarly publications reporting innovative research results. In most cases, it would not be feasible to sidetrack the research goals of early career scientists by placing them into a formal teacher preparation program. But what happens when postdoctoral research scientists take an active role in clinical teacher preparation as part of their research appointments? The American Museum of Natural History's Masters of Arts in Teaching (AMNH-MAT) urban residency pilot program utilizes a unique approach to grade 7 - 12 Earth Science teacher

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

Ongoing Evaluation of Clinical Ethics Consultations as a Form of Continuous Quality Improvement.

Science.gov (United States)

Volpe, Rebecca

2017-01-01

Ongoing evaluation of a clinical ethics consultation service (ECS) allows for continuous quality improvement, a process-based, data-driven approach for improving the quality of a service. Evaluations by stakeholders involved in a consultation can provide real-time feedback about what is working well and what might need to be improved. Although numerous authors have previously presented data from research studies on the effectiveness of clinical ethics consultation, few ECSs routinely send evaluations as an ongoing component of their everyday clinical activities. The primary purpose of this article is to equip and encourage others to engage in ongoing evaluation of their own ECS. Toward that end, the following resources are shared: (1) the survey tool used to gather the evaluation data, (2) the procedure used to elicit and collate responses, and (3) how the resulting data are used to support continuous quality improvement and justify the continued financial support of the ECS to hospital administration. Copyright 2017 The Journal of Clinical Ethics. All rights reserved.

Differentiating Research, Quality Improvement, and Case Studies to Ethically Incorporate Pregnant Women.

Science.gov (United States)

Phillippi, Julia C; Hartmann, Katherine E

2018-01-01

Pregnant women have been called therapeutic orphans because data supporting common interventions, medications, health teaching, and models of care are meager. The generation of quality evidence benefits from proactive approaches that ensure ethical standards are met to protect participants. The purpose of this article is to differentiate among health care, quality improvement, and research and to discuss ethical involvement of women who are pregnant and potentially childbearing in these initiatives. Health care is provided to protect and improve individual health. Quality improvement aims to enhance delivery of care for all those receiving care in particular settings. Research, whether retrospective or prospective, is designed to contribute to generalizable knowledge. This review includes vignettes to distinguish between research, quality improvement, and case study dissemination and to highlight the value of publication of information with applicability beyond a single site. As a community, perinatal care providers will be able to contribute more evidence to guide care if they err on the side of seeking institutional review board approval for activities that examine the care and outcomes of pregnant women and the fetus. Traditional research activities, including clinical trials, remain crucial. However, to fill gaps in knowledge, we must expedite our ability to report informative cases, examine clinical data, share lessons learned during quality improvement campaigns, and publish and disseminate these findings. Accelerating improvements in care demands expansion of the evidence base. © 2017 by the American College of Nurse-Midwives.

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.

Easily configured real-time CPOE Pick Off Tool supporting focused clinical research and quality improvement.

Science.gov (United States)

Rosenbaum, Benjamin P; Silkin, Nikolay; Miller, Randolph A

2014-01-01

Real-time alerting systems typically warn providers about abnormal laboratory results or medication interactions. For more complex tasks, institutions create site-wide 'data warehouses' to support quality audits and longitudinal research. Sophisticated systems like i2b2 or Stanford's STRIDE utilize data warehouses to identify cohorts for research and quality monitoring. However, substantial resources are required to install and maintain such systems. For more modest goals, an organization desiring merely to identify patients with 'isolation' orders, or to determine patients' eligibility for clinical trials, may adopt a simpler, limited approach based on processing the output of one clinical system, and not a data warehouse. We describe a limited, order-entry-based, real-time 'pick off' tool, utilizing public domain software (PHP, MySQL). Through a web interface the tool assists users in constructing complex order-related queries and auto-generates corresponding database queries that can be executed at recurring intervals. We describe successful application of the tool for research and quality monitoring.

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.

Engaging Clinical Nurses in Quality Improvement Projects.

Science.gov (United States)

Moore, Susan; Stichler, Jaynelle F

2015-10-01

Clinical nurses have the knowledge and expertise required to provide efficient and proficient patient care. Time and knowledge deficits can prevent nurses from developing and implementing quality improvement or evidence-based practice projects. This article reviews a process for professional development of clinical nurses that helped them to define, implement, and analyze quality improvement or evidence-based practice projects. The purpose of this project was to educate advanced clinical nurses to manage a change project from inception to completion, using the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) Change Acceleration Process as a framework. One-to-one mentoring and didactic in-services advanced the knowledge, appreciation, and practice of advanced practice clinicians who completed multiple change projects. The projects facilitated clinical practice changes, with improved patient outcomes; a unit cultural shift, with appreciation of quality improvement and evidence-based projects; and engagement with colleagues. Project outcomes were displayed in poster presentations at a hospital exposition for knowledge dissemination. Copyright 2015, SLACK Incorporated.

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.

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.

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

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.

Guide to clinical PET in oncology: Improving clinical management of cancer patients

International Nuclear Information System (INIS)

2008-10-01

information on clinical PET in oncology for nuclear medicine physicians, radiologists and clinical practitioners. Possible ideas for cost effectiveness of clinical PET in oncology are mentioned. The information is also intended to be useful in decision making to improve clinical management of cancer patients when allocating resources dedicated to the health care system. This is a critical issue that is important for the development of both clinical oncology and nuclear medicine in IAEA member states. The IAEA can be instrumental in the advancement of programmes which focus on the IAEA's coordinated research projects and technical cooperation project

Physician participation in clinical research and trials: issues and approaches

Directory of Open Access Journals (Sweden)

Sami F Shaban

2011-03-01

research culture’. This article examines the barriers to and benefits of physician participation in clinical research as well as interventions needed to increase their participation, including the specific role of undergraduate medical education. The main challenge is the unwillingness of many physicians and patients to participate in clinical trials. Barriers to participation include lack of time, lack of resources, trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians, and sometimes a scientifically uninteresting research question, among others. Strategies to encourage physician participation in clinical research include financial and nonfinancial incentives, adequate training, research questions that are in line with physician interests and have clear potential to improve patient care, and regular feedback. Finally, encouraging research culture and fostering the development of inquiry and research-based learning among medical students is now a high priority in order to develop more and better clinician-researchers.Keywords: physician, clinical research, clinical trial, medical education

The impact of clinical research activities on communities in rural Africa: the development of the Clinical Research Unit of Nanoro (CRUN) in Burkina Faso.

Science.gov (United States)

Tinto, Halidou; Valea, Innocent; Sorgho, Hermann; Tahita, Marc Christian; Traore, Maminata; Bihoun, Biébo; Guiraud, Issa; Kpoda, Hervé; Rouamba, Jérémi; Ouédraogo, Sayouba; Lompo, Palpouguini; Yara, Sandrine; Kabore, William; Ouédraogo, Jean-Bosco; Guiguemdé, Robert Tinga; Binka, Fred N; Ogutu, Bernhards

2014-03-22

The opportunities for developing new drugs and vaccines for malaria control look brighter now than ten years ago. However, there are few places in sub-Saharan Africa with the necessary infrastructure and expertise to support such research in compliance to international standards of clinical research (ICH-GCP). The Clinical Research Unit of Nanoro (CRUN) was founded in 2008 to provide a much-needed GCP-compliant clinical trial platform for an imminent large-scale Phase 3 malaria vaccine trial. A dynamic approach was used that entailed developing the required infrastructure and human resources, while engaging local communities in the process as key stakeholders. This provided a better understanding and ownership of the research activities by the local population. Within five years (2008-2013), the CRUN set up a fully and well-equipped GCP-compliant clinical trial research facility, which enabled to attract 25 grants. The research team grew from ten health workers prior to 2008 to 254 in 2013. A Health and Demographic Surveillance System (HDSS), which covers a total population of about 60,000 people in 24 villages was set up in the district. The local community contributed to the development of the facility through the leadership of the king and the mayor of Nanoro. As a result of their active advocacy, the government extended the national electrical grid to the new research center, and later to the entire village. This produced a positive impact on the community's quality of life. The quality of health care improved substantially, due to the creation of more elaborate clinical laboratory services and the acquisition of state-of-the-art equipment. Involving the community in the key steps of establishing the centre provided the foundation for what was to become the CRUN success story. This experience demonstrates that when clinical trials research sites are carefully developed and implemented, they can have a positive and powerful impact on local communities in

Electronic health records improve clinical note quality.

Science.gov (United States)

Burke, Harry B; Sessums, Laura L; Hoang, Albert; Becher, Dorothy A; Fontelo, Paul; Liu, Fang; Stephens, Mark; Pangaro, Louis N; O'Malley, Patrick G; Baxi, Nancy S; Bunt, Christopher W; Capaldi, Vincent F; Chen, Julie M; Cooper, Barbara A; Djuric, David A; Hodge, Joshua A; Kane, Shawn; Magee, Charles; Makary, Zizette R; Mallory, Renee M; Miller, Thomas; Saperstein, Adam; Servey, Jessica; Gimbel, Ronald W

2015-01-01

The clinical note documents the clinician's information collection, problem assessment, clinical management, and its used for administrative purposes. Electronic health records (EHRs) are being implemented in clinical practices throughout the USA yet it is not known whether they improve the quality of clinical notes. The goal in this study was to determine if EHRs improve the quality of outpatient clinical notes. A five and a half year longitudinal retrospective multicenter quantitative study comparing the quality of handwritten and electronic outpatient clinical visit notes for 100 patients with type 2 diabetes at three time points: 6 months prior to the introduction of the EHR (before-EHR), 6 months after the introduction of the EHR (after-EHR), and 5 years after the introduction of the EHR (5-year-EHR). QNOTE, a validated quantitative instrument, was used to assess the quality of outpatient clinical notes. Its scores can range from a low of 0 to a high of 100. Sixteen primary care physicians with active practices used QNOTE to determine the quality of the 300 patient notes. The before-EHR, after-EHR, and 5-year-EHR grand mean scores (SD) were 52.0 (18.4), 61.2 (16.3), and 80.4 (8.9), respectively, and the change in scores for before-EHR to after-EHR and before-EHR to 5-year-EHR were 18% (pquality scores significantly improved over the 5-year time interval. The EHR significantly improved the overall quality of the outpatient clinical note and the quality of all its elements, including the core and non-core elements. To our knowledge, this is the first study to demonstrate that the EHR significantly improves the quality of clinical notes. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Improving Care And Research Electronic Data Trust Antwerp (iCAREdata): a research database of linked data on out-of-hours primary care.

Science.gov (United States)

Colliers, Annelies; Bartholomeeusen, Stefaan; Remmen, Roy; Coenen, Samuel; Michiels, Barbara; Bastiaens, Hilde; Van Royen, Paul; Verhoeven, Veronique; Holmgren, Philip; De Ruyck, Bernard; Philips, Hilde

2016-05-04

Primary out-of-hours care is developing throughout Europe. High-quality databases with linked data from primary health services can help to improve research and future health services. In 2014, a central clinical research database infrastructure was established (iCAREdata: Improving Care And Research Electronic Data Trust Antwerp, www.icaredata.eu ) for primary and interdisciplinary health care at the University of Antwerp, linking data from General Practice Cooperatives, Emergency Departments and Pharmacies during out-of-hours care. Medical data are pseudonymised using the services of a Trusted Third Party, which encodes private information about patients and physicians before data is sent to iCAREdata. iCAREdata provides many new research opportunities in the fields of clinical epidemiology, health care management and quality of care. A key aspect will be to ensure the quality of data registration by all health care providers. This article describes the establishment of a research database and the possibilities of linking data from different primary out-of-hours care providers, with the potential to help to improve research and the quality of health care services.

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

Science.gov (United States)

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

2016-07-11

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

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.

Using Lean to Advance Quality Improvement Research.

Science.gov (United States)

Blackmore, Christopher Craig; Williams, Barbara L; Ching, Joan M; Chafetz, Lynne A; Kaplan, Gary S

2016-01-01

Quality improvement research skills are not commonplace among quality improvement practitioners, and research on the effectiveness of quality improvement has not always kept pace with improvement innovation. However, the Lean tools applied to quality improvement should be equally relevant to the advancement of quality improvement research. We applied the Lean methods to develop a simplified quality improvement publication pathway enabling a small research methodology group to increase quality improvement research throughout the institution. The key innovations of the pathway are horizontal integration of the quality improvement research methods group across the institution, implementation of a Lean quality improvement research pathway, and application of a just-in-time quality improvement research toolkit. This work provides a road map and tools for the acceleration of quality improvement research. At our institution, the Lean quality improvement research approach was associated with statistically significant increases in the number (annual mean increase from 3.0 to 8.5, p = .03) and breadth of published quality improvement research articles, and in the number of quality improvement research projects currently in process. Application of Lean methods to the quality improvement research process can aid in increasing publication of quality improvement articles from across the institution.

Encouraging student-driven clinical research in Germany: the CHIR-Net SIGMA network

Directory of Open Access Journals (Sweden)

Frey Pia-Elena

2017-11-01

Full Text Available Evidence should define and guide modern clinical care, yet many relevant questions in surgical practice remain unconfirmed by substantial data. Evidence-based medicine requires both the implementation of its principles in day-to-day work and the acquisition of new evidence preferably by randomized controlled trials and systematic reviews. Meaningful clinical research, however, is challenging to conduct, and its overall infrastructure in Germany was, until recently, considered poor compared to other leading countries. Although this has been significantly improved after the establishment of the Study Center of the German Surgical Society (SDGC and the surgical clinical trial network CHIR-Net, limited focus has been put on the training, teaching, and recruitment of medical students to become competent clinical researchers and clinician scientists. To ensure continuing comprehensive clinical research in surgery, CHIR-Net aims to establish a student-driven multicenter research network in Germany, which is embedded in both the national CHIR-Net and the pan-European and international frameworks. Student-Initiated German Medical Audits (SIGMA is a product of the strong collaboration between clinical scientists and medical trainees, enabling students to contribute to high-quality clinical trials. Additionally, participants are offered extensive training to support the next generation of research-active clinicians. Starting on 2018, SIGMA will perform its first multicenter observational study in Germany.

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.

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...

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

Science.gov (United States)

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

2016-05-01

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

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

An International Basic Science and Clinical Research Summer Program for Medical Students

Science.gov (United States)

Ramjiawan, Bram; Pierce, Grant N.; Anindo, Mohammad Iffat Kabir; AlKukhun, Abedalrazaq; Alshammari, Abdullah; Chamsi, Ahmad Talal; Abousaleh, Mohannad; Alkhani, Anas; Ganguly, Pallab K.

2012-01-01

An important part of training the next generation of physicians is ensuring that they are exposed to the integral role that research plays in improving medical treatment. However, medical students often do not have sufficient time to be trained to carry out any projects in biomedical and clinical research. Many medical students also fail to…

Researchers' Roles in Patient Safety Improvement.

Science.gov (United States)

Pietikäinen, Elina; Reiman, Teemu; Heikkilä, Jouko; Macchi, Luigi

2016-03-01

In this article, we explore how researchers can contribute to patient safety improvement. We aim to expand the instrumental role researchers have often occupied in relation to patient safety improvement. We reflect on our own improvement model and experiences as patient safety researchers in an ongoing Finnish multi-actor innovation project through self-reflective narration. Our own patient safety improvement model can be described as systemic. Based on the purpose of the innovation project, our improvement model, and the improvement models of the other actors in the project, we have carried out a wide range of activities. Our activities can be summarized in 8 overlapping patient safety improvement roles: modeler, influencer, supplier, producer, ideator, reflector, facilitator, and negotiator. When working side by side with "practice," researchers are offered and engage in several different activities. The way researchers contribute to patient safety improvement and balance between different roles depends on the purpose of the study, as well as on the underlying patient safety improvement models. Different patient safety research paradigms seem to emphasize different improvement roles, and thus, they also face different challenges. Open reflection on the underlying improvement models and roles can help researchers with different backgrounds-as well as other actors involved in patient safety improvement-in structuring their work and collaborating productively.

Emerging uses of patient generated health data in clinical research.

Science.gov (United States)

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

2015-05-01

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

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 ...

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.

The clinical nurse specialist: leadership in quality improvement.

Science.gov (United States)

Finkelman, Anita

2013-01-01

Healthcare delivery is in a crisis, requiring improvement. How to improve and who should assume more leadership are not clear. At the same time, the nursing profession struggles with a weak education system, graduating students who require major support for an extended time. There is also confusion related to nursing roles, particularly with nurses who have a graduate degree. The Institute of Medicine has published a series of reports about the healthcare system and need for improvement and describes a structure for improvement. The clinical nurse specialist is particularly suited to assume a major role in nursing leadership to guide staff and the healthcare system to better ensure improved care. There is great need to communicate that the clinical nurse specialist can and should assume this role. This will require a review and development of more quality improvement content and experiences in clinical nurse specialist educational programs, but much of the content is already in programs. The clinical nurse specialist works in systems, impacts systems, works with staff, and can thus reach more patients with improvement approaches.

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/.

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.

Turning Failure into Success: Trials of the Heart Failure Clinical Research Network.

Science.gov (United States)

Joyce, Emer; Givertz, Michael M

2016-12-01

The Heart Failure Clinical Research Network (HFN) was established in 2008 on behalf of the NIH National Heart, Lung and Blood Institute, with the primary goal of improving outcomes in heart failure (HF) by designing and conducting high-quality concurrent clinical trials testing interventions across the spectrum of HF. Completed HFN trials have answered several important and relevant clinical questions concerning the safety and efficacy of different decongestive and adjunctive vasodilator therapies in hospitalized acute HF, phosphodiesterase-5 inhibition and nitrate therapies in HF with preserved ejection fraction, and the role of xanthine oxidase inhibition in hyperuricemic HF. These successes, independent of the "positive" or "negative" result of each individual trial, have helped to shape the current clinical care of HF patients and serve as a platform to inform future research directions and trial designs.

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.
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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.

Audit filters for improving processes of care and clinical outcomes in trauma systems.

Science.gov (United States)

Evans, Christopher; Howes, Daniel; Pickett, William; Dagnone, Luigi

2009-10-07

Traumatic injuries represent a considerable public health burden with significant personal and societal costs. The care of the severely injured patient in a trauma system progresses along a continuum that includes numerous interventions being provided by a multidisciplinary group of healthcare personnel. Despite the recent emphasis on quality of care in medicine, there has been little research to direct trauma clinicians and administrators on how optimally to monitor and improve upon the quality of care delivered within a trauma system. Audit filters are one mechanism for improving quality of care and are defined as specific clinical processes or outcomes of care that, when they occur, represent unfavorable deviations from an established norm and which prompt review and feedback. Although audit filters are widely utilized for performance improvement in trauma systems they have not been subjected to systematic review of their effectiveness. To determine the effectiveness of using audit filters for improving processes of care and clinical outcomes in trauma systems. Our search strategy included an electronic search of the Cochrane Injuries Group Specialized Register, the Cochrane EPOC Group Specialized Register, CENTRAL (The Cochrane Library 2008, Issue 4), MEDLINE, PubMed, EMBASE, CINAHL, and ISI Web of Science: (SCI-EXPANDED and CPCI-S). We handsearched the Journal of Trauma, Injury, Annals of Emergency Medicine, Academic Emergency Medicine, and Injury Prevention. We searched two clinical trial registries: 1) The World Health Organization International Clinical Trials Registry Platform and, 2) Clinical Trials.gov. We also contacted content experts for further articles. The most recent electronic search was completed in December 2008 and the handsearch was completed up to February 2009. We searched for randomized controlled trials, controlled clinical trials, controlled before-and-after studies, and interrupted time series studies that used audit filters as an

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.

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.

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches.

Science.gov (United States)

Elliott, Daisy; Husbands, Samantha; Hamdy, Freddie C; Holmberg, Lars; Donovan, Jenny L

2017-11-01

The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improve-recruitment and informed consent within a range of clinical trials. A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups

NHS Trusts' clinical research activity and overall CQC performance - Is there a correlation?

Science.gov (United States)

Jonker, L; Fisher, S J

2015-11-01

Since the late 2000's, the creation of the National Institute for Health Research (NIHR) has transformed clinical research activity in the United Kingdom. This study sought to establish if there is a link between clinical research activity and overall NHS Trust performance. Retrospective cohort study. Data for NHS Trust performance were obtained from public databases, namely the Care Quality Commission (CQC) 2013 risk rating for overall performance, and 2012-13 NIHR records for clinical research activity. Applying Spearman's rank analysis, none of the Trust categories showed a correlation with CQC risk rating: small hospitals, r = -0.062 (P = 0.76; n = 27); medium, r = -0.224 (P = 0.13; n = 47); large, r = -0.008 (P = 0.96; n = 57); academic, r = -0.18 (P = 0.41; n = 24). Similar results were observed when CQC risk rating was compared with the number of different clinical research studies conducted per Trust. The degree of NIHR National Portfolio clinical research activity is not significantly related to CQC risk rating, used as an indicator of overall NHS Trust performance. Other studies have previously shown that increased research activity correlates with improved mortality rates, one component of CQC risk rating scores. Alternative tools may have to be explored to evaluate the impact of clinical research on NHS Trusts and its patients. Copyright © 2015 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?

Science.gov (United States)

Sawata, Hiroshi; Tsutani, Kiichiro

2011-06-29

Clinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting large-scale clinical trials entails high research costs. This study sought to investigate global trends in large-scale clinical trials in cardiovascular diseases. We searched for trials using clinicaltrials.gov (URL: http://www.clinicaltrials.gov/) using the key words 'cardio' and 'event' in all fields on 10 April, 2010. We then selected trials with 300 or more participants examining cardiovascular diseases. The search revealed 344 trials that met our criteria. Of 344 trials, 71% were randomized controlled trials, 15% involved more than 10,000 participants, and 59% were funded by industry. In RCTs whose results were disclosed, 55% of industry-funded trials and 25% of non-industry funded trials reported statistically significant superiority over control (p = 0.012, 2-sided Fisher's exact test). Our findings highlighted concerns regarding potential bias related to funding sources, and that researchers should be aware of the importance of trial information disclosures and conflicts of interest. We should keep considering management and training regarding information disclosures and conflicts of interest for researchers. This could lead to better clinical evidence and further improvements in the development of medical treatment worldwide.

Improving a Dental School's Clinic Operations Using Lean Process Improvement.

Science.gov (United States)

Robinson, Fonda G; Cunningham, Larry L; Turner, Sharon P; Lindroth, John; Ray, Deborah; Khan, Talib; Yates, Audrey

2016-10-01

The term "lean production," also known as "Lean," describes a process of operations management pioneered at the Toyota Motor Company that contributed significantly to the success of the company. Although developed by Toyota, the Lean process has been implemented at many other organizations, including those in health care, and should be considered by dental schools in evaluating their clinical operations. Lean combines engineering principles with operations management and improvement tools to optimize business and operating processes. One of the core concepts is relentless elimination of waste (non-value-added components of a process). Another key concept is utilization of individuals closest to the actual work to analyze and improve the process. When the medical center of the University of Kentucky adopted the Lean process for improving clinical operations, members of the College of Dentistry trained in the process applied the techniques to improve inefficient operations at the Walk-In Dental Clinic. The purpose of this project was to reduce patients' average in-the-door-to-out-the-door time from over four hours to three hours within 90 days. Achievement of this goal was realized by streamlining patient flow and strategically relocating key phases of the process. This initiative resulted in patient benefits such as shortening average in-the-door-to-out-the-door time by over an hour, improving satisfaction by 21%, and reducing negative comments by 24%, as well as providing opportunity to implement the electronic health record, improving teamwork, and enhancing educational experiences for students. These benefits were achieved while maintaining high-quality patient care with zero adverse outcomes during and two years following the process improvement project.

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

Science.gov (United States)

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

2014-01-01

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

A data-rich recruitment core to support translational clinical research.

Science.gov (United States)

Kost, Rhonda G; Corregano, Lauren M; Rainer, Tyler-Lauren; Melendez, Caroline; Coller, Barry S

2015-04-01

Underenrollment of clinical studies wastes resources and delays assessment of research discoveries. We describe the organization and impact of a centralized recruitment core delivering comprehensive recruitment support to investigators. The Rockefeller University Center for Clinical and Translational Science supports a centralized recruitment core, call center, Research Volunteer Repository, data infrastructure, and staff who provide expert recruitment services to investigators. During protocol development, consultations aim to optimize enrollment feasibility, develop recruitment strategy, budget, and advertising. Services during study conduct include advertising placement, repository queries, call management, prescreening, referral, and visit scheduling. Utilization and recruitment outcomes are tracked using dedicated software. For protocols receiving recruitment services during 2009-2013: median time from initiation of recruitment to the first enrolled participant was 10 days; of 4,047 first-time callers to the call center, 92% (n = 3,722) enrolled in the Research Volunteer Repository, with 99% retention; 23% of Repository enrollees subsequently enrolled in ≥1 research studies, with 89% retention. Of volunteers referred by repository queries, 49% (280/537) enrolled into the study, with 92% retained. Provision of robust recruitment infrastructure including expertise, a volunteer repository, data capture and real-time analysis accelerates protocol accrual. Application of recruitment science improves the quality of clinical investigation. © 2014 Wiley Periodicals, Inc.

A Data‐Rich Recruitment Core to Support Translational Clinical Research

Science.gov (United States)

Corregano, Lauren M.; Rainer, Tyler‐Lauren; Melendez, Caroline; Coller, Barry S.

2014-01-01

Abstract Background Underenrollment of clinical studies wastes resources and delays assessment of research discoveries. We describe the organization and impact of a centralized recruitment core delivering comprehensive recruitment support to investigators. Methods The Rockefeller University Center for Clinical and Translational Science supports a centralized recruitment core, call center, Research Volunteer Repository, data infrastructure, and staff who provide expert recruitment services to investigators. During protocol development, consultations aim to optimize enrollment feasibility, develop recruitment strategy, budget, and advertising. Services during study conduct include advertising placement, repository queries, call management, prescreening, referral, and visit scheduling. Utilization and recruitment outcomes are tracked using dedicated software. Results For protocols receiving recruitment services during 2009–2013: median time from initiation of recruitment to the first enrolled participant was 10 days; of 4,047 first‐time callers to the call center, 92% (n = 3,722) enrolled in the Research Volunteer Repository, with 99% retention; 23% of Repository enrollees subsequently enrolled in ≥1 research studies, with 89% retention. Of volunteers referred by repository queries, 49% (280/537) enrolled into the study, with 92% retained. Conclusions Provision of robust recruitment infrastructure including expertise, a volunteer repository, data capture and real‐time analysis accelerates protocol accrual. Application of recruitment science improves the quality of clinical investigation. PMID:25381717

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

Directory of Open Access Journals (Sweden)

Ignacio Segarra

2017-07-01

Full Text Available The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug–drug interactions (DDI to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs and Research Ethics Committees (RECs. We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies.

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...

A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project

OpenAIRE

Mosconi, Paola; Antes, Gerd; Barbareschi, Giorgio; Burls, Amanda; Demotes-Mainard, Jacques; Chalmers, Iain; Colombo, Cinzia; Garattini, Silvio; Gluud, Christian; Gyte, Gill; Mcllwain, Catherine; Penfold, Matt; Post, Nils; Satolli, Roberto; Valetto, Maria Rosa

2016-01-01

BACKGROUND: The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe. \\ud \\ud METHODS: Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in s...

A Mixed-Methods Research Framework for Healthcare Process Improvement.

Science.gov (United States)

Bastian, Nathaniel D; Munoz, David; Ventura, Marta

2016-01-01

The healthcare system in the United States is spiraling out of control due to ever-increasing costs without significant improvements in quality, access to care, satisfaction, and efficiency. Efficient workflow is paramount to improving healthcare value while maintaining the utmost standards of patient care and provider satisfaction in high stress environments. This article provides healthcare managers and quality engineers with a practical healthcare process improvement framework to assess, measure and improve clinical workflow processes. The proposed mixed-methods research framework integrates qualitative and quantitative tools to foster the improvement of processes and workflow in a systematic way. The framework consists of three distinct phases: 1) stakeholder analysis, 2a) survey design, 2b) time-motion study, and 3) process improvement. The proposed framework is applied to the pediatric intensive care unit of the Penn State Hershey Children's Hospital. The implementation of this methodology led to identification and categorization of different workflow tasks and activities into both value-added and non-value added in an effort to provide more valuable and higher quality patient care. Based upon the lessons learned from the case study, the three-phase methodology provides a better, broader, leaner, and holistic assessment of clinical workflow. The proposed framework can be implemented in various healthcare settings to support continuous improvement efforts in which complexity is a daily element that impacts workflow. We proffer a general methodology for process improvement in a healthcare setting, providing decision makers and stakeholders with a useful framework to help their organizations improve efficiency. Published by Elsevier Inc.

Improving clinical drug development regulatory procedures for anticonvulsants

Directory of Open Access Journals (Sweden)

Janković Slobodan

2015-01-01

Full Text Available Background: Clinical development of antiepileptic drugs is demanding due to complex character of the disorder and to diversity of its forms and etiologies. Objective: The aim of this review was to suggest improvements in regulatory procedures for clinical development of antiepileptic drugs. Methods: The following databases of scientific articles were searched: MEDLINE, SCOPUS and SCINDEKS. In total 558 publications were retrieved. The types of articles selected were reviews, reports on clinical trials and letters to the Editor. Results: There are several changes of regulatory documents necessary for improving process of clinical development of antiepileptic drugs: preference of parallel groups design for add-on trials should be explicit; the noninferiority design for monotherapy clinical trials should be acceptable; restrictive formulations when trials of antiepileptic drugs in children are in question should be avoided; requirements in regard to the efficacy measures should be harmonized among the regulatory bodies; proactive attitude towards discovery of adverse events; and precise requirements for clinical trials specifically designed to prove anti-epileptogenic effects should be made clear. Conclusion: Current regulatory documents are incomplete in many aspects; an international effort to improve and harmonize guidelines for clinical development of antiepileptic drugs is necessary for improvement of this process.

MedAustron – Non-Clinical Research Opportunities

International Nuclear Information System (INIS)

Schreiner, T.

2013-01-01

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

[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...

[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...

Teacher Research as Continuous Process Improvement

Science.gov (United States)

Ellis, Charles; Castle, Kathryn

2010-01-01

Purpose: Teacher research (inquiry) has been characterized as practice improvement, professional development and action research, among numerous names and descriptions. The purpose of this paper is to support the case that teacher research is also a form of quality improvement known as continuous process improvement (CPI).…

[Clinical research activity of the French cancer cooperative network: Overview and perspectives].

Science.gov (United States)

Dubois, Claire; Morin, Franck; Moro-Sibilot, Denis; Langlais, Alexandra; Seitz, Jean-François; Girault, Cécile; Salles, Gilles; Haioun, Corinne; Deschaseaux, Pascal; Casassus, Philippe; Mathiot, Claire; Pujade-Lauraine, Éric; Votan, Bénédicte; Louvet, Christophe; Delpeut, Christine; Bardet, Étienne; Vintonenko, Nadejda; Hoang Xuan, Khê; Vo, Maryline; Michon, Jean; Milleron, Bernard

The French Cancer Plan 2014-2019 stresses the importance of strengthening collaboration between all stakeholders involved in the fight against cancer, including cancer cooperative groups and intergroups. This survey aimed to describe the basics characteristics and clinical research activity among the Cancer Cooperative Groups (Groupes coopérateurs en oncologie). The second objective was to identify facilitators and barriers to their research activity. A questionnaire was sent to all the clinicians involved in 2014 as investigators in a clinical trial sponsored by one of the ten members of the Cancer Cooperative Groups network. The questions were related to their profile, research activity and the infrastructure existing within their healthcare center to support clinical research and related compliance activities. In total, 366 investigators responded to our survey. The academic clinical trials sponsored by the Cancer Cooperative Groups represented an important part of the research activity of the investigators in France in 2014. These academic groups contributed to the opening of many research sites throughout all regions in France. Factors associated with a higher participation of investigators (more than 10 patients enrolled in a trial over a year) include the existing support of healthcare professionals (more than 2 clinical research associate (CRA) OR=11.16 [3.82-32.6] compared to none) and the practice of their research activity in a University Hospital Center (CHU) rather than a Hospital Center (CH) (OR=2.15 [1.20-3.83]). This study highlighted factors that can strengthen investigator clinical research activities and subsequently improve patient access to evidence-based new cancer therapies in France. Copyright © 2017 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Clinical nursing and midwifery research in African countries: a scoping review.

Science.gov (United States)

Sun, Carolyn; Larson, Elaine

2015-05-01

Globally, the nursing shortage has been deemed a crisis, but African countries have been hit hardest. Therefore, it is of utmost importance nurses use the best available evidence and that nursing research is targeted to address gaps in the evidence. To achieve this, an understanding of what is currently available and identification of gaps in clinical nursing research is critical. We performed a scoping review of existing literature to assess clinical nursing research conducted in all African countries over the past decade, identify gaps in clinical nursing and midwifery research, determine whether they match with health priorities for countries, and define priorities for regional clinical nursing research agendas to improve health outcomes. This is a scoping review of published clinical nursing research conducted in African countries. Systematic searches of literature published between January 01, 2004 and September 15, 2014 were performed in PubMed, Medline, CINHAL, and Embase. Research was included if it was conducted by nurses, included data obtained in African countries or regions within the African continent, published in a peer-reviewed journal with an abstract, and included patient outcomes. Abstracts were independently reviewed for inclusion by two authors. The following data were extracted: countries of publication and study, study type and design, journal, language, and topics of research. Gaps in the literature were identified. Initially, 1091 papers were identified with a final sample of 73 articles meeting inclusion criteria. Studies used 12 designs, were published in 35 journals published in five countries (including two African countries); 29% of the research was published in a single journal (Curatonis). Research was mostly qualitative (57%) and included twenty countries in Africa (38%). There were 12 major topics of study, most often midwifery/maternal/child health (43%), patient experiences (38%), and human immunodeficiency virus (HIV

Health information exchanges--Unfulfilled promise as a data source for clinical research.

Science.gov (United States)

Parker, Carol; Weiner, Michael; Reeves, Mathew

2016-03-01

To determine the use of health information exchange organizations (HIEs) to support and conduct clinical research. This scoping review included US-based studies published between January 2003 and March 2014 that used data from an HIE to address at least one of three categories of research: clinical or epidemiological research, financial evaluation, or utilization of health services. Eligibility was not restricted to research on HIEs. Studies with research questions outside of the evaluation of HIEs themselves were sought. Eighteen articles met final study inclusion criteria from an initial list of 847 hits. Fifteen studies addressed a clinical or epidemiological research question, 6 addressed a financial consideration, and 8 addressed a utilization issue. Considerable overlap was found among the research categories: 13 articles addressed more than one category. Of the eighteen included studies, only two used HIE data to answer a research objective that was NOT specific to HIE use. Research designs were varied and ranged from observational studies, such as cohort and cross-sectional studies, to randomized trials. The 18 articles represent the involvement of a small number of HIEs; 7 of the studies were from a single HIE. This review demonstrates that HIE-provided information is available and used to answer clinical or epidemiological, financial, or utilization-based research questions; however, the majority of the studies using HIE data are done with the primary goal of evaluating the use and impact of HIEs on health care delivery and outcomes. As HIEs mature and become integrated parts of the health care industry, the authors anticipate that fewer studies will be published that describe or validate the role of HIEs, and more will use HIEs as multi-institutional data sources for conducting clinical research and improving health services and clinical outcomes. Articles identified in this review indicate the limited extent that HIE data are being used for clinical

Pursuing Improvement in Clinical Reasoning: The Integrated Clinical Education Theory.

Science.gov (United States)

Jessee, Mary Ann

2018-01-01

The link between clinical education and development of clinical reasoning is not well supported by one theoretical perspective. Learning to reason during clinical education may be best achieved in a supportive sociocultural context of nursing practice that maximizes reasoning opportunities and facilitates discourse and meaningful feedback. Prelicensure clinical education seldom incorporates these critical components and thus may fail to directly promote clinical reasoning skill. Theoretical frameworks supporting the development of clinical reasoning during clinical education were evaluated. Analysis of strengths and gaps in each framework's support of clinical reasoning development was conducted. Commensurability of philosophical underpinnings was confirmed, and complex relationships among key concepts were elucidated. Six key concepts and three tenets comprise an explanatory predictive theory-the integrated clinical education theory (ICET). ICET provides critical theoretical support for inquiry and action to promote clinical education that improves development of clinical reasoning skill. [J Nurs Educ. 2018;57(1):7-13.]. Copyright 2018, SLACK Incorporated.

Building Surgical Research Capacity Globally: Efficacy of a Clinical Research Course for Surgeons in Low-Resource Settings

Directory of Open Access Journals (Sweden)

Theodore A. Miclau

2017-11-01

Full Text Available Musculoskeletal injury confers an enormous burden of preventable disability and mortality in low- and moderate-income countries (LMICs. Appropriate orthopedic and trauma care services are lacking. Leading international health agencies emphasize the critical need to create and sustain research capacity in the developing world as a strategic factor in the establishment of functional, independent health systems. One aspect of building research capacity is partnership between developing and developed countries, and knowledge sharing via these collaborations. This study evaluated the efficacy of a short, intensive course designed to educate surgeons on fundamental aspects of clinical research using evidence-based medicine (EBM principles. Orthopedic surgeons from the United States and Canada presented a one-day course on the fundamentals of clinical research in Havana, Cuba. Knowledge acquisition was assessed on the part of course participants and surveyed current involvement with and attitudes toward clinical research. Questionnaires were presented to participants immediately preceding and following the course. The mean pre-test score was 43.9% (95% CI: 41.1–46.6%. The mean post-test score was 59.3% (95% CI: 56.5–62.1%. There were relative score increases in each subgroup based on professional level, subjective level of familiarity with EBM concepts, and subjective level of experience in research. This study establishes the short-term efficacy of an intensive course designed to impart knowledge in EBM and clinical research. Further study is necessary to determine the long-term benefits of this type of course. This may be a useful part of an overall strategy to build health research capacity in LMICs, ultimately contributing to improved access to high-quality surgical care.

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

Translational educational research: a necessity for effective health-care improvement.

Science.gov (United States)

McGaghie, William C; Issenberg, S Barry; Cohen, Elaine R; Barsuk, Jeffrey H; Wayne, Diane B

2012-11-01

Medical education research contributes to translational science (TS) when its outcomes not only impact educational settings, but also downstream results, including better patient-care practices and improved patient outcomes. Simulation-based medical education (SBME) has demonstrated its role in achieving such distal results. Effective TS also encompasses implementation science, the science of health-care delivery. Educational, clinical, quality, and safety goals can only be achieved by thematic, sustained, and cumulative research programs, not isolated studies. Components of an SBME TS research program include motivated learners, curriculum grounded in evidence-based learning theory, educational resources, evaluation of downstream results, a productive research team, rigorous research methods, research resources, and health-care system acceptance and implementation. National research priorities are served from translational educational research. National funding priorities should endorse the contribution and value of translational education research.

Transparency in the reporting of in vivo pre-clinical pain research: The relevance and implications of the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines.

Science.gov (United States)

Rice, Andrew S C; Morland, Rosemary; Huang, Wenlong; Currie, Gillian L; Sena, Emily S; Macleod, Malcolm R

2017-12-29

Clear reporting of research is crucial to the scientific process. Poorly designed and reported studies are damaging not only to the efforts of individual researchers, but also to science as a whole. Standardised reporting methods, such as those already established for reporting randomised clinical trials, have led to improved study design and facilitated the processes of clinical systematic review and meta-analysis. Such standards were lacking in the pre-clinical field until the development of the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines. These were prompted following a survey which highlighted a widespread lack of robust and consistent reporting of pre-clinical in vivo research, with reports frequently omitting basic information required for study replication and quality assessment. The resulting twenty item checklist in ARRIVE covers all aspects of experimental design with particular emphasis on bias reduction and methodological transparency. Influential publishers and research funders have already adopted ARRIVE. Further dissemination and acknowledgement of the importance of these guidelines is vital to their widespread implementation. Conclusions and implications Wide implementation of the ARRIVE guidelines for reporting of in vivo preclinical research, especially pain research, are essential for a much needed increased transparency and quality in publishing such research. ARRIVE will also positively influence improvements in experimental design and quality, assist the conduct of accurate replication studies of important new findings and facilitate meta-analyses of preclinical research.

Engaging pediatric intensive care unit (PICU) clinical staff to lead practice improvement: the PICU participatory action research project (PICU-PAR).

Science.gov (United States)

Collet, Jean-Paul; Skippen, Peter W; Mosavianpour, Mir Kaber; Pitfield, Alexander; Chakraborty, Bubli; Hunte, Garth; Lindstrom, Ronald; Kissoon, Niranjan; McKellin, William H

2014-01-08

Despite considerable efforts, engaging staff to lead quality improvement activities in practice settings is a persistent challenge. At British Columbia Children's Hospital (BCCH), the pediatric intensive care unit (PICU) undertook a new phase of quality improvement actions based on the Community of Practice (CoP) model with Participatory Action Research (PAR). This approach aims to mobilize the PICU 'community' as a whole with a focus on practice; namely, to create a 'community of practice' to support reflection, learning, and innovation in everyday work. An iterative two-stage PAR process using mixed methods has been developed among the PICU CoP to describe the environment (stage 1) and implement specific interventions (stage 2). Stage 1 is ethnographic description of the unit's care practice. Surveys, interviews, focus groups, and direct observations describe the clinical staff's experiences and perspectives around bedside care and quality endeavors in the PICU. Contrasts and comparisons across participants, time and activities help understanding the PICU culture and experience. Stage 2 is a succession of PAR spirals, using results from phase 1 to set up specific interventions aimed at building the staff's capability to conduct QI projects while acquiring appropriate technical skills and leadership capacity (primary outcome). Team communication, information, and interaction will be enhanced through a knowledge exchange (KE) and a wireless network of iPADs. Lack of leadership at the staff level in order to improve daily practice is a recognized challenge that faces many hospitals. We believe that the PAR approach within a highly motivated CoP is a sound method to create the social dynamic and cultural context within which clinical teams can grow, reflect, innovate and feel proud to better serve patients.

The evolving professional identity of the clinical research nurse: A qualitative exploration.

Science.gov (United States)

Kunhunny, Swapna; Salmon, Debra

2017-12-01

To examine the perspectives of CRNs in the UK on their professional role identity, in order to inform the professional practice of Clinical Research Nursing. Clinical research nurses (CRN) make a significant contribution to healthcare research within the UK and internationally. However, lack of clarity about their role, and scope of practice renders their contribution within the profession and in the minds of the wider public invisible. This has implications in terms of promoting the role nurses play not only in terms of recruitment, retention, and care of research participants but also as research leaders of the future. Exploratory qualitative design using thematic analysis conducted within a realist paradigm. Participants viewed the positive aspects of their identity 'as agents of change' who were fundamental to the clinical research process. Resourcefulness and the ability to guide members of the research team were valued as key to job satisfaction. Successful navigation through the complexity of advice, support, management and leadership tasks related to their role in caring for research patients were role affirming and generated a sense of pride. However, lack of recognition, clarity of the role and career development opportunities within an identified structure undermined the CRN identity and optimism about progression in the future. Participants reported feeling invisible to colleagues within the clinical community, isolated and excluded from wider nursing groups. The study describes UK CRN practice, highlighting the positive benefits and challenges associated with the role, including the need to support professional and career development to maximise their research contribution. This study provides nurses, health care and research organisations and academic nursing educators with a broadened understanding of the professional role, identity and context of clinical research nursing practice in the United Kingdom, with recommendations to improve its

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.

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

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

How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?

Directory of Open Access Journals (Sweden)

Tsutani Kiichiro

2011-06-01

Full Text Available Abstract Background Clinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting large-scale clinical trials entails high research costs. This study sought to investigate global trends in large-scale clinical trials in cardiovascular diseases. Findings We searched for trials using clinicaltrials.gov (URL: http://www.clinicaltrials.gov/ using the key words 'cardio' and 'event' in all fields on 10 April, 2010. We then selected trials with 300 or more participants examining cardiovascular diseases. The search revealed 344 trials that met our criteria. Of 344 trials, 71% were randomized controlled trials, 15% involved more than 10,000 participants, and 59% were funded by industry. In RCTs whose results were disclosed, 55% of industry-funded trials and 25% of non-industry funded trials reported statistically significant superiority over control (p = 0.012, 2-sided Fisher's exact test. Conclusions Our findings highlighted concerns regarding potential bias related to funding sources, and that researchers should be aware of the importance of trial information disclosures and conflicts of interest. We should keep considering management and training regarding information disclosures and conflicts of interest for researchers. This could lead to better clinical evidence and further improvements in the development of medical treatment worldwide.

The Cervix Cancer Research Network (CCRN: Increasing access to cancer clinical trials in low- and middle-income countries

Directory of Open Access Journals (Sweden)

Gita eSuneja

2015-02-01

Full Text Available Introduction: The burden of cervical cancer is large and growing in developing countries, due in large part to limited access to screening services and lack of human papillomavirus (HPV vaccination. In spite of modern advances in diagnostic and therapeutic modalities, outcomes from cervical cancer have not markedly improved in recent years. Novel clinical trials are urgently needed to improve outcomes from cervical cancer worldwide. Methods: The Cervix Cancer Research Network (CCRN, a subsidiary of the Gynecologic Cancer InterGroup (GCIG, is a multi-national, multi-institutional consortium of physicians and scientists focused on improving cervical cancer outcomes worldwide by making cancer clinical trials available in low-, middle-, and high-income countries. Standard operating procedures for participation in CCRN include a pre-qualifying questionnaire to evaluate clinical activities and research infrastructure, followed by a site visit. Once a site is approved, they may choose to participate in one of four currently accruing clinical trials.Results: To date, 13 different CCRN site visits have been performed. Of these 13 sites visited, 10 have been approved as CCRN sites including Tata Memorial Hospital, India; Bangalore, India; Trivandrum, India; Ramathibodi, Thailand; Siriaj, Thailand; Pramongkutklao, Thailand; Ho Chi Minh, Vietnam; Blokhin Russian Cancer Research Center; the Hertzen Moscow Cancer Research Institute; and the Russian Scientific Center of Roentgenoradiology. The four currently accruing clinical trials are TACO, OUTBACK, INTERLACE, and SHAPE.Discussion: The CCRN has successfully enrolled 10 sites in developing countries to participate in four randomized clinical trials. The primary objectives are to provide novel therapeutics to regions with the greatest need and to improve the validity and generalizability of clinical trial results by enrolling a diverse sample of patients.

Security Approaches in Using Tablet Computers for Primary Data Collection in Clinical Research

OpenAIRE

Wilcox, Adam B.; Gallagher, Kathleen; Bakken, Suzanne

2013-01-01

Next-generation tablets (iPads and Android tablets) may potentially improve the collection and management of clinical research data. The widespread adoption of tablets, coupled with decreased software and hardware costs, has led to increased consideration of tablets for primary research data collection. When using tablets for the Washington Heights/Inwood Infrastructure for Comparative Effectiveness Research (WICER) project, we found that the devices give rise to inherent security issues asso...

Nursing clinical practice changes to improve self-management in chronic obstructive pulmonary disease.

Science.gov (United States)

Padilha, J M; Sousa, P A F; Pereira, F M S

2018-03-01

To propose nursing clinical practice changes to improve the development of patient self-management. Chronic obstructive pulmonary disease is one of the main causes of chronic morbidity, loss of quality of life and high mortality rates. Control of the disease's progression, the preservation of autonomy in self-care and maintenance of quality of life are extremely challenging for patients to execute in their daily living. However, there is still little evidence to support nursing clinical practice changes to improve the development of self-management. A participatory action research study was performed in a medicine inpatient department and the outpatient unit of a Portuguese hospital. The sample comprised 52 nurses and 99 patients. For data collection, we used interviews, participant observation and content analysis. The main elements of nursing clinical practice that were identified as a focus for improvement measures were the healthcare model, the organization of healthcare and the documentation of a support decision-making process. The specific guidelines, the provision of material to support decision-making and the optimization of information sharing between professionals positively influenced the change process. This change improved the development of self-management skills related to the awareness of the need for 'change', hope, involvement, knowledge and abilities. The implemented changes have improved health-related behaviours and clinical outcomes. To support self-management development skills, an effective nursing clinical practice change is needed. This study has demonstrated the relevance of a portfolio of techniques and tools to help patients adopt healthy behaviours. The involvement and participation of nurses and patients in the conceptualization, implementation and evaluation of policy change are fundamental issues to improve the quality of nursing care and clinical outcomes. © 2017 International Council of Nurses.

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.

Improving clinical leadership and management in the NHS

Directory of Open Access Journals (Sweden)

Nicol ED

2012-08-01

Full Text Available Edward D Nicol1,21Department of Cardiology, Royal Brompton Hospital and Harefield NHS Trust, London, United Kingdom; 2Clinical Leadership Academy, School of Medicine, Keele University, Staffordshire, United KingdomAbstract: The National Health Service (NHS is one of the UKs most cherished but political public institutions, providing healthcare, free at the point of delivery. The English NHS must make £20bn efficiency savings in the next 3 years whilst in the midst of fundamental structural change outlined in the government's Health and Social Care Bill. This paper will explore the history of leadership and management in the NHS; the evolution of clinical leadership; national strategies to improve NHS clinical and managerial leadership and Lord Darzi's pivotal NHS review. It defines the kind of leadership and management required for today's NHS, looking to overcome some of the main challenges such as improving healthcare quality whilst making efficiency savings and engaging grass roots workers to deliver sustainable, long term improvements. Finally this manuscript makes suggestions as to where future investment is required to improve clinical leadership and management in the NHS.Keywords: clinical leadership, healthcare management, national health service

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...

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

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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...

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

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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...

[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.

Research on Clinical Preventive Services for Adolescents and Young Adults: Where Are We and Where Do We Need to Go?

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Harris, Sion K; Aalsma, Matthew C; Weitzman, Elissa R; Garcia-Huidobro, Diego; Wong, Charlene; Hadland, Scott E; Santelli, John; Park, M Jane; Ozer, Elizabeth M

2017-03-01

We reviewed research regarding system- and visit-level strategies to enhance clinical preventive service delivery and quality for adolescents and young adults. Despite professional consensus on recommended services for adolescents, a strong evidence base for services for young adults, and improved financial access to services with the Affordable Care Act's provisions, receipt of preventive services remains suboptimal. Further research that builds off successful models of linking traditional and community clinics is needed to improve access to care for all youth. To optimize the clinical encounter, promising clinician-focused strategies to improve delivery of preventive services include screening and decision support tools, particularly when integrated into electronic medical record systems and supported by training and feedback. Although results have been mixed, interventions have moved beyond increasing service delivery to demonstrating behavior change. Research on emerging technology-such as gaming platforms, mobile phone applications, and wearable devices-suggests opportunities to expand clinicians' reach; however, existing research is based on limited clinical settings and populations. Improved monitoring systems and further research are needed to examine preventive services facilitators and ensure that interventions are effective across the range of clinical settings where youth receive preventive care, across multiple populations, including young adults, and for more vulnerable populations with less access to quality care. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

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

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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...

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

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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...

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...

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

Developing a Mental Health eClinic to Improve Access to and Quality of Mental Health Care for Young People: Using Participatory Design as Research Methodologies.

Science.gov (United States)

Ospina-Pinillos, Laura; Davenport, Tracey A; Ricci, Cristina S; Milton, Alyssa C; Scott, Elizabeth M; Hickie, Ian B

2018-05-28

Each year, many young Australians aged between 16 and 25 years experience a mental health disorder, yet only a small proportion access services and even fewer receive timely and evidence-based treatments. Today, with ever-increasing access to the Internet and use of technology, the potential to provide all young people with access (24 hours a day, 7 days a week) to the support they require to improve their mental health and well-being is promising. The aim of this study was to use participatory design (PD) as research methodologies with end users (young people aged between 16 and 25 years and youth health professionals) and our research team to develop the Mental Health eClinic (a Web-based mental health clinic) to improve timely access to, and better quality, mental health care for young people across Australia. A research and development (R&D) cycle for the codesign and build of the Mental Health eClinic included several iterative PD phases: PD workshops; translation of knowledge and ideas generated during workshops to produce mockups of webpages either as hand-drawn sketches or as wireframes (simple layout of a webpage before visual design and content is added); rapid prototyping; and one-on-one consultations with end users to assess the usability of the alpha build of the Mental Health eClinic. Four PD workshops were held with 28 end users (young people n=18, youth health professionals n=10) and our research team (n=8). Each PD workshop was followed by a knowledge translation session. At the conclusion of this cycle, the alpha prototype was built, and one round of one-on-one end user consultation sessions was conducted (n=6; all new participants, young people n=4, youth health professionals n=2). The R&D cycle revealed the importance of five key components for the Mental Health eClinic: a home page with a visible triage system for those requiring urgent help; a comprehensive online physical and mental health assessment; a detailed dashboard of results; a

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.

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.

Engaging Pediatric Intensive Care Unit (PICU) clinical staff to lead practice improvement: the PICU Participatory Action Research Project (PICU-PAR)

Science.gov (United States)

2014-01-01

Background Despite considerable efforts, engaging staff to lead quality improvement activities in practice settings is a persistent challenge. At British Columbia Children’s Hospital (BCCH), the pediatric intensive care unit (PICU) undertook a new phase of quality improvement actions based on the Community of Practice (CoP) model with Participatory Action Research (PAR). This approach aims to mobilize the PICU ‘community’ as a whole with a focus on practice; namely, to create a ‘community of practice’ to support reflection, learning, and innovation in everyday work. Methodology An iterative two-stage PAR process using mixed methods has been developed among the PICU CoP to describe the environment (stage 1) and implement specific interventions (stage 2). Stage 1 is ethnographic description of the unit’s care practice. Surveys, interviews, focus groups, and direct observations describe the clinical staff’s experiences and perspectives around bedside care and quality endeavors in the PICU. Contrasts and comparisons across participants, time and activities help understanding the PICU culture and experience. Stage 2 is a succession of PAR spirals, using results from phase 1 to set up specific interventions aimed at building the staff’s capability to conduct QI projects while acquiring appropriate technical skills and leadership capacity (primary outcome). Team communication, information, and interaction will be enhanced through a knowledge exchange (KE) and a wireless network of iPADs. Relevance Lack of leadership at the staff level in order to improve daily practice is a recognized challenge that faces many hospitals. We believe that the PAR approach within a highly motivated CoP is a sound method to create the social dynamic and cultural context within which clinical teams can grow, reflect, innovate and feel proud to better serve patients. PMID:24401288

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].

[Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].

Science.gov (United States)

Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador

2016-10-01

Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

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.

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.

Engaging Nurses in Research for a Randomized Clinical Trial of a Behavioral Health Intervention

Directory of Open Access Journals (Sweden)

Lona Roll

2013-01-01

Full Text Available Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.

Strategies for addressing barriers to publishing pediatric quality improvement research.

Science.gov (United States)

Van Cleave, Jeanne; Dougherty, Denise; Perrin, James M

2011-09-01

Advancing the science of quality improvement (QI) requires dissemination of the results of QI. However, the results of few QI interventions reach publication. To identify barriers to publishing results of pediatric QI research and provide practical strategies that QI researchers can use to enhance publishability of their work. We reviewed and summarized a workshop conducted at the Pediatric Academic Societies 2007 meeting in Toronto, Ontario, Canada, on conducting and publishing QI research. We also interviewed 7 experts (QI researchers, administrators, journal editors, and health services researchers who have reviewed QI manuscripts) about common reasons that QI research fails to reach publication. We also reviewed recently published pediatric QI articles to find specific examples of tactics to enhance publishability, as identified in interviews and the workshop. We found barriers at all stages of the QI process, from identifying an appropriate quality issue to address to drafting the manuscript. Strategies for overcoming these barriers included collaborating with research methodologists, creating incentives to publish, choosing a study design to include a control group, increasing sample size through research networks, and choosing appropriate process and clinical quality measures. Several well-conducted, successfully published QI studies in pediatrics offer guidance to other researchers in implementing these strategies in their own work. Specific, feasible approaches can be used to improve opportunities for publication in pediatric, QI, and general medical journals.

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.

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

Constructing a Local Potential Participant Registry to Improve Alzheimer's Disease Clinical Research Recruitment.

Science.gov (United States)

Grill, Joshua D; Hoang, Dan; Gillen, Daniel L; Cox, Chelsea G; Gombosev, Adrijana; Klein, Kirsten; O'Leary, Steve; Witbracht, Megan; Pierce, Aimee

2018-01-01

Potential participant registries are tools to address the challenge of slow recruitment to clinical research. In particular, registries may aid recruitment to secondary prevention clinical trials for Alzheimer's disease (AD), which enroll cognitively normal older individuals meeting specific genetic or biomarker criteria. Evidence of registry effectiveness is sparse, as is guidance on optimal designs or methods of conduct. We report our experiences of developing a novel local potential participant registry that implemented online enrollment and data collection. In the first year of operation, 957 individuals submitted email addresses to the registry, of whom 592 self-reported demographic, family history, and medical data. In addition, registrants provided information related to their interest and willingness to be contacted about studies. Local earned media and community education were the most effective methods of recruitment into the registry. Seventy-six (26%) of 298 registrants contacted about studies in the first year enrolled in those studies. One hundred twenty-nine registrants were invited to enroll in a preclinical AD trial, of whom 25 (18%) screened and 6 were randomized. These results indicate that registries can aid recruitment and provide needed guidance for investigators initiating new local registries.

Study protocol: national research partnership to improve primary health care performance and outcomes for Indigenous peoples

Directory of Open Access Journals (Sweden)

McDermott Robyn

2010-05-01

Full Text Available Abstract Background Strengthening primary health care is critical to reducing health inequity between Indigenous and non-Indigenous Australians. The Audit and Best practice for Chronic Disease Extension (ABCDE project has facilitated the implementation of modern Continuous Quality Improvement (CQI approaches in Indigenous community health care centres across Australia. The project demonstrated improvements in health centre systems, delivery of primary care services and in patient intermediate outcomes. It has also highlighted substantial variation in quality of care. Through a partnership between academic researchers, service providers and policy makers, we are now implementing a study which aims to 1 explore the factors associated with variation in clinical performance; 2 examine specific strategies that have been effective in improving primary care clinical performance; and 3 work with health service staff, management and policy makers to enhance the effective implementation of successful strategies. Methods/Design The study will be conducted in Indigenous community health centres from at least six States/Territories (Northern Territory, Western Australia, New South Wales, South Australia, Queensland and Victoria over a five year period. A research hub will be established in each region to support collection and reporting of quantitative and qualitative clinical and health centre system performance data, to investigate factors affecting variation in quality of care and to facilitate effective translation of research evidence into policy and practice. The project is supported by a web-based information system, providing automated analysis and reporting of clinical care performance to health centre staff and management. Discussion By linking researchers directly to users of research (service providers, managers and policy makers, the partnership is well placed to generate new knowledge on effective strategies for improving the quality of primary

An international basic science and clinical research summer program for medical students.

Science.gov (United States)

Ramjiawan, Bram; Pierce, Grant N; Anindo, Mohammad Iffat Kabir; Alkukhun, Abedalrazaq; Alshammari, Abdullah; Chamsi, Ahmad Talal; Abousaleh, Mohannad; Alkhani, Anas; Ganguly, Pallab K

2012-03-01

An important part of training the next generation of physicians is ensuring that they are exposed to the integral role that research plays in improving medical treatment. However, medical students often do not have sufficient time to be trained to carry out any projects in biomedical and clinical research. Many medical students also fail to understand and grasp translational research as an important concept today. In addition, since medical training is often an international affair whereby a medical student/resident/fellow will likely train in many different countries during his/her early training years, it is important to provide a learning environment whereby a young medical student experiences the unique challenges and value of an international educational experience. This article describes a program that bridges the gap between the basic and clinical research concepts in a unique international educational experience. After completing two semester curricula at Alfaisal University in Riyadh, Kingdom of Saudi Arabia, six medical students undertook a summer program at St. Boniface Hospital Research Centre, in Winnipeg, MB, Canada. The program lasted for 2 mo and addressed advanced training in basic science research topics in medicine such as cell isolation, functional assessment, and molecular techniques of analysis and manipulation as well as sessions on the conduct of clinical research trials, ethics, and intellectual property management. Programs such as these are essential to provide a base from which medical students can decide if research is an attractive career choice for them during their clinical practice in subsequent years. An innovative international summer research course for medical students is necessary to cater to the needs of the medical students in the 21st century.

Creating an effort tracking tool to improve therapeutic cancer clinical trials workload management and budgeting.

Science.gov (United States)

James, Pam; Bebee, Patty; Beekman, Linda; Browning, David; Innes, Mathew; Kain, Jeannie; Royce-Westcott, Theresa; Waldinger, Marcy

2011-11-01

Quantifying data management and regulatory workload for clinical research is a difficult task that would benefit from a robust tool to assess and allocate effort. As in most clinical research environments, The University of Michigan Comprehensive Cancer Center (UMCCC) Clinical Trials Office (CTO) struggled to effectively allocate data management and regulatory time with frequently inaccurate estimates of how much time was required to complete the specific tasks performed by each role. In a dynamic clinical research environment in which volume and intensity of work ebbs and flows, determining requisite effort to meet study objectives was challenging. In addition, a data-driven understanding of how much staff time was required to complete a clinical trial was desired to ensure accurate trial budget development and effective cost recovery. Accordingly, the UMCCC CTO developed and implemented a Web-based effort-tracking application with the goal of determining the true costs of data management and regulatory staff effort in clinical trials. This tool was developed, implemented, and refined over a 3-year period. This article describes the process improvement and subsequent leveling of workload within data management and regulatory that enhanced the efficiency of UMCCC's clinical trials operation.

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...

Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project.

Science.gov (United States)

Beresniak, Ariel; Schmidt, Andreas; Proeve, Johann; Bolanos, Elena; Patel, Neelam; Ammour, Nadir; Sundgren, Mats; Ericson, Mats; Karakoyun, Töresin; Coorevits, Pascal; Kalra, Dipak; De Moor, Georges; Dupont, Danielle

2016-01-01

The widespread adoption of electronic health records (EHR) provides a new opportunity to improve the efficiency of clinical research. The European EHR4CR (Electronic Health Records for Clinical Research) 4-year project has developed an innovative technological platform to enable the re-use of EHR data for clinical research. The objective of this cost-benefit assessment (CBA) is to assess the value of EHR4CR solutions compared to current practices, from the perspective of sponsors of clinical trials. A CBA model was developed using an advanced modeling approach. The costs of performing three clinical research scenarios (S) applied to a hypothetical Phase II or III oncology clinical trial workflow (reference case) were estimated under current and EHR4CR conditions, namely protocol feasibility assessment (S1), patient identification for recruitment (S2), and clinical study execution (S3). The potential benefits were calculated considering that the estimated reduction in actual person-time and costs for performing EHR4CR S1, S2, and S3 would accelerate time to market (TTM). Probabilistic sensitivity analyses using Monte Carlo simulations were conducted to manage uncertainty. Should the estimated efficiency gains achieved with the EHR4CR platform translate into faster TTM, the expected benefits for the global pharmaceutical oncology sector were estimated at €161.5m (S1), €45.7m (S2), €204.5m (S1+S2), €1906m (S3), and up to €2121.8m (S1+S2+S3) when the scenarios were used sequentially. The results suggest that optimizing clinical trial design and execution with the EHR4CR platform would generate substantial added value for pharmaceutical industry, as main sponsors of clinical trials in Europe, and beyond. Copyright © 2015 Elsevier Inc. All rights reserved.

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)

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

stakeholders' individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research.

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

clinical research quality across stakeholders’ individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research. PMID:28715491

Comprehensive Clinical Audits of Diagnostic Radiology Practices: A Tool for Quality Improvement. Quality Assurance Audit for Diagnostic Radiology Improvement and Learning (QUAADRIL)

International Nuclear Information System (INIS)

2011-01-01

Interest in quality assurance processes and quality improvement in diagnostic radiology is being driven by a number of factors. These include the high cost and complexity of radiological equipment, acknowledgement of the possibility of increasing doses to patients, and the importance of radiological diagnosis to patient management within the health care environment. To acknowledge these interests, clinical audits have been introduced and, in Europe, mandated under a European Directive (Council Directive 97/47/EURATOM). Comprehensive clinical audits focus on clinical management and infrastructure, patient related and technical procedures, and education and research. This publication includes a structured set of standards appropriate for diagnostic radiology, an audit guide to their clinical review, and data collection sheets for the rapid production of reports in audit situations. It will be a useful guide for diagnostic radiology facilities wishing to improve their service to patients through timely diagnosis with minimal radiation dose.

Comprehensive Clinical Audits of Diagnostic Radiology Practices: A Tool for Quality Improvement. Quality Assurance Audit for Diagnostic Radiology Improvement and Learning (QUAADRIL)

International Nuclear Information System (INIS)

2010-01-01

Interest in quality assurance processes and quality improvement in diagnostic radiology is being driven by a number of factors. These include the high cost and complexity of radiological equipment, acknowledgement of the possibility of increasing doses to patients, and the importance of radiological diagnosis to patient management within the health care environment. To acknowledge these interests, clinical audits have been introduced and, in Europe, mandated under a European Directive (Council Directive 97/47/EURATOM). Comprehensive clinical audits focus on clinical management and infrastructure, patient related and technical procedures, and education and research. This publication includes a structured set of standards appropriate for diagnostic radiology, an audit guide to their clinical review, and data collection sheets for the rapid production of reports in audit situations. It will be a useful guide for diagnostic radiology facilities wishing to improve their service to patients through timely diagnosis with minimal radiation dose.

Exploring factors related to the translation of collaborative research learning experiences into clinical practice: Opportunities and tensions.

Science.gov (United States)

Fletcher, Simon; Whiting, Cheryl; Boaz, Annette; Reeves, Scott

2017-07-01

Providing training opportunities to develop research skills for clinical staff has been prioritised in response to the need for improving the evidence base underpinning the delivery of care. By exploring the experiences of a number of former participants of a multidisciplinary postgraduate research course, this article explores the factors that have enabled and impeded staff to translate their learnt research skills into clinical practice. Adopting an exploratory case study approach, 16 interviews with 5 cohorts of Masters by Research in Clinical Practice (MResCP) graduates were undertaken. The interviews explored graduates' course experiences and their subsequent attempts to undertake clinical research. Analysis of the data indicated that although participants valued their interactions with colleagues from different professions and felt they gained useful research skills/knowledge, upon returning to clinical practice, they encountered a number of barriers which restricted their ability to apply their research expertise. Professional isolation, issues of hierarchy, and a lack of organisational support were key to limiting their ability to undertake clinical research. Further work is needed to explore in more depth how (i) these barriers can be overcome and (ii) how taught collaborative research skills can be more effectively translated into practice.

Internet addiction and problematic Internet use: A systematic review of clinical research.

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Kuss, Daria J; Lopez-Fernandez, Olatz

2016-03-22

To provide a comprehensive overview of clinical studies on the clinical picture of Internet-use related addictions from a holistic perspective. A literature search was conducted using the database Web of Science. Over the last 15 years, the number of Internet users has increased by 1000%, and at the same time, research on addictive Internet use has proliferated. Internet addiction has not yet been understood very well, and research on its etiology and natural history is still in its infancy. In 2013, the American Psychiatric Association included Internet Gaming Disorder in the appendix of the updated version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) as condition that requires further research prior to official inclusion in the main manual, with important repercussions for research and treatment. To date, reviews have focused on clinical and treatment studies of Internet addiction and Internet Gaming Disorder. This arguably limits the analysis to a specific diagnosis of a potential disorder that has not yet been officially recognised in the Western world, rather than a comprehensive and inclusive investigation of Internet-use related addictions (including problematic Internet use) more generally. The systematic literature review identified a total of 46 relevant studies. The included studies used clinical samples, and focused on characteristics of treatment seekers and online addiction treatment. Four main types of clinical research studies were identified, namely research involving (1) treatment seeker characteristics; (2) psychopharmacotherapy; (3) psychological therapy; and (4) combined treatment. A consensus regarding diagnostic criteria and measures is needed to improve reliability across studies and to develop effective and efficient treatment approaches for treatment seekers.

Internet addiction and problematic Internet use: A systematic review of clinical research

Science.gov (United States)

Kuss, Daria J; Lopez-Fernandez, Olatz

2016-01-01

AIM: To provide a comprehensive overview of clinical studies on the clinical picture of Internet-use related addictions from a holistic perspective. A literature search was conducted using the database Web of Science. METHODS: Over the last 15 years, the number of Internet users has increased by 1000%, and at the same time, research on addictive Internet use has proliferated. Internet addiction has not yet been understood very well, and research on its etiology and natural history is still in its infancy. In 2013, the American Psychiatric Association included Internet Gaming Disorder in the appendix of the updated version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) as condition that requires further research prior to official inclusion in the main manual, with important repercussions for research and treatment. To date, reviews have focused on clinical and treatment studies of Internet addiction and Internet Gaming Disorder. This arguably limits the analysis to a specific diagnosis of a potential disorder that has not yet been officially recognised in the Western world, rather than a comprehensive and inclusive investigation of Internet-use related addictions (including problematic Internet use) more generally. RESULTS: The systematic literature review identified a total of 46 relevant studies. The included studies used clinical samples, and focused on characteristics of treatment seekers and online addiction treatment. Four main types of clinical research studies were identified, namely research involving (1) treatment seeker characteristics; (2) psychopharmacotherapy; (3) psychological therapy; and (4) combined treatment. CONCLUSION: A consensus regarding diagnostic criteria and measures is needed to improve reliability across studies and to develop effective and efficient treatment approaches for treatment seekers. PMID:27014605

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.

Need for global partnership in cancer care: perceptions of cancer care researchers attending the 2010 australia and Asia pacific clinical oncology research development workshop.

Science.gov (United States)

Lyerly, H Kim; Abernethy, Amy P; Stockler, Martin R; Koczwara, Bogda; Aziz, Zeba; Nair, Reena; Seymour, Lesley

2011-09-01

To understand the diversity of issues and the breadth of growing clinical care, professional education, and clinical research needs of developing countries, not typically represented in Western or European surveys of cancer care and research. A cross-sectional survey was conducted of the attendees at the 2010 Australia and Asia Pacific Clinical Oncology Research Development workshop (Queensland, Australia) about the most important health care questions facing the participant's home countries, especially concerning cancer. Early-career oncologists and advanced oncology trainees from a region of the world containing significant low- and middle-income countries reported that cancer is an emerging health priority as a result of aging of the population, the impact of diet and lifestyle, and environmental pollution. There was concern about the capacity of health care workers and treatment facilities to provide cancer care and access to the latest cancer therapies and technologies. Although improving health care delivery was seen as a critical local agenda priority, focusing on improved cancer research activities in this select population was seen as the best way that others outside the country could improve outcomes for all. The burden of cancer will increase dramatically over the next 20 years, particularly in countries with developing and middle-income economies. Cancer research globally faces significant barriers, many of which are magnified in the developing country setting. Overcoming these barriers will require partnerships sensitive and responsive to both local and global needs.

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

Science.gov (United States)

Dawson, Liza; Zwerski, Sheryl

2015-06-01

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

Clinical research in dermatology: resources and activities associated with a higher scientific productivity.

Science.gov (United States)

Molina-Leyva, Alejandro; Descalzo, Miguel A; García-Doval, Ignacio

2018-03-06

Clinical research papers and their derived metrics can be useful to assess the scientific production of medical and research centers. Diverse factors are probably associated to differences in scientific production. But there are scarce studies analyzing them. Resources are limited and have to be distributed efficiently. The objective of this study is to explore what resources and activities are potentially associated with a higher scientific productivity. A bibliometric study was performed to obtain information about scientific productivity. Papers included had to meet criteria to be considered clinical research in dermatology, additionally had to be published between the years 2005-2014, had to be included in Pubmed or Embase and had to include a Spanish center of dermatology as the correspondence address. Information about research resources and activities of the year 2015 was gathered by means of an online survey sent to the authors identified in the bibliometric study. The search strategy returned 8617 papers and only 1104 of them (12.81%) met the inclusion criteria. 63 out of 113 centers responded to the survey (55.75%). Factors associated with a higher scientific productivity were: the size of the resident program, the amount of time specifically dedicated to research, a lower clinical workload, and the number of clinical trials performed in the last year. We have demonstrated that some factors are associated with a higher scientific productivity. Residency program, more research staff, clinical workload redistribution and research motivation/initiatives are key strategies that could improve scientific productivity of a center.

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...

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.

Improving Immunizations in Children: A Clinical Break-even Analysis.

Science.gov (United States)

Jones, Kyle Bradford; Spain, Chad; Wright, Hannah; Gren, Lisa H

2015-06-01

Immunizing the population is a vital public health priority. This article describes a resident-led continuous quality improvement project to improve the immunization rates of children under 3 years of age at two urban family medicine residency clinics in Salt Lake City, Utah, as well as a break-even cost analysis to the clinics for the intervention. Immunization records were distributed to provider-medical assistant teamlets daily for each pediatric patient scheduled in clinic to decrease missed opportunities. An outreach intervention by letter, followed by telephone call reminders, was conducted to reach children under 3 years of age who were behind on recommended immunizations for age (total n=457; those behind on immunizations n=101). Immunization rates were monitored at 3 months following start of intervention. A break-even analysis to the clinics for the outreach intervention was performed. Immunizations were improved from a baseline of 75.1% (n=133) and 79.6% (n=223) at the two clinics to 92.1% (n=163) and 89.6% (n=251), respectively, at 3 months following the start of intervention (Pbreak-even point required 36 immunizations to be administered. Significant improvement in the immunization rate of patients under 3 years of age at two family medicine residency training clinics was achieved through decreasing missed opportunities for immunization in clinic, and with outreach through letters and follow-up phone calls. The intervention showed positive revenue to both clinics. © 2015 Marshfield Clinic.

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.

Improvement Science Meets Improvement Scholarship: Reframing Research for Better Healthcare.

Science.gov (United States)

Cribb, Alan

2018-06-01

In this editorial essay I explore the possibilities of 'improvement scholarship' in order to set the scene for the theme of, and the other papers in, this issue. I contrast a narrow conception of quality improvement (QI) research with a much broader and more inclusive conception, arguing that we should greatly extend the existing dialogue between 'problem-solving' and 'critical' currents in improvement research. I have in mind the potential for building a much larger conversation between those people in 'improvement science' who are expressly concerned with tackling the problems facing healthcare and the wider group of colleagues who are engaged in health-related scholarship but who do not see themselves as particularly interested in quality improvement, indeed who may be critical of the language or concerns of QI. As one contribution to that conversation I suggest that that the increasing emphasis on theory and rigour in improvement research should include more focus on normative theory and rigour. The remaining papers in the issue are introduced including the various ways in which they handle the 'implicit normativity' of QI research and practice, and the linked theme of combining relatively 'tidy' and potentially 'unruly' forms of knowledge.

Improving Bioscience Research Reporting: The ARRIVE Guidelines for Reporting Animal Research

Directory of Open Access Journals (Sweden)

Carol Kilkenny

2014-02-01

Full Text Available In the last decade the number of bioscience journals has increased enormously, with many filling specialised niches reflecting new disciplines and technologies. The emergence of open-access journals has revolutionised the publication process, maximising the availability of research data. Nevertheless, a wealth of evidence shows that across many areas, the reporting of biomedical research is often inadequate, leading to the view that even if the science is sound, in many cases the publications themselves are not “fit for purpose”, meaning that incomplete reporting of relevant information effectively renders many publications of limited value as instruments to inform policy or clinical and scientific practice [1–21]. A recent review of clinical research showed that there is considerable cumulative waste of financial resources at all stages of the research process, including as a result of publications that are unusable due to poor reporting [22]. It is unlikely that this issue is confined to clinical research [2–14,16–20].

Stakeholder-Driven Quality Improvement: A Compelling Force for Clinical Practice Guidelines.

Science.gov (United States)

Rosenfeld, Richard M; Wyer, Peter C

2018-01-01

Clinical practice guideline development should be driven by rigorous methodology, but what is less clear is where quality improvement enters the process: should it be a priority-guiding force, or should it enter only after recommendations are formulated? We argue for a stakeholder-driven approach to guideline development, with an overriding goal of quality improvement based on stakeholder perceptions of needs, uncertainties, and knowledge gaps. In contrast, the widely used topic-driven approach, which often makes recommendations based only on randomized controlled trials, is driven by epidemiologic purity and evidence rigor, with quality improvement a downstream consideration. The advantages of a stakeholder-driven versus a topic-driven approach are highlighted by comparisons of guidelines for otitis media with effusion, thyroid nodules, sepsis, and acute bacterial rhinosinusitis. These comparisons show that stakeholder-driven guidelines are more likely to address the quality improvement needs and pressing concerns of clinicians and patients, including understudied populations and patients with multiple chronic conditions. Conversely, a topic-driven approach often addresses "typical" patients, based on research that may not reflect the needs of high-risk groups excluded from studies because of ethical issues or a desire for purity of research design.

[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.

The improved Clinical Global Impression Scale (iCGI: development and validation in depression

Directory of Open Access Journals (Sweden)

Kadouri Alane

2007-02-01

Full Text Available Abstract Background The Clinical Global Impression scale (CGI is frequently used in medical care and clinical research because of its face validity and practicability. This study proposes to improve the reliability of the Clinical Global Impression (CGI scale in depressive disorders by the use of a semi-standardized interview, a new response format, and a Delphi procedure. Methods Thirty patients hospitalised for a major depressive episode were filmed at T1 (first week in hospital and at T2 (2 weeks later during a 5' specific interview. The Hamilton Depressive Rating Scale and the Symptom Check List were also rated. Eleven psychiatrists rated these videos using either the usual CGI response format or an improved response format, with or without a Delphi procedure. Results The new response format slightly improved (but not significantly the interrater agreement, the Delphi procedure did not. The best results were obtained when ratings by 4 independent raters were averaged. In this situation, intraclass correlation coefficients were about 0.9. Conclusion The Clinical Global Impression is a useful approach in psychiatry since it apprehends patients in their entirety. This study shows that it is possible to quantify such impressions with a high level of interrater agreement.

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

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

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.

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.

Implementation strategies of Systems Medicine in clinical research and home care for cardiovascular disease patients.

Science.gov (United States)

Montecucco, Fabrizio; Carbone, Federico; Dini, Frank Lloyd; Fiuza, Manuela; Pinto, Fausto J; Martelli, Antonietta; Palombo, Domenico; Sambuceti, Gianmario; Mach, François; De Caterina, Raffaele

2014-11-01

Insights from the "-omics" science have recently emphasized the need to implement an overall strategy in medical research. Here, the development of Systems Medicine has been indicated as a potential tool for clinical translation of basic research discoveries. Systems Medicine also gives the opportunity of improving different steps in medical practice, from diagnosis to healthcare management, including clinical research. The development of Systems Medicine is still hampered however by several challenges, the main one being the development of computational tools adequate to record, analyze and share a large amount of disparate data. In addition, available informatics tools appear not yet fully suitable for the challenge because they are not standardized, not universally available, or with ethical/legal concerns. Cardiovascular diseases (CVD) are a very promising area for translating Systems Medicine into clinical practice. By developing clinically applied technologies, the collection and analysis of data may improve CV risk stratification and prediction. Standardized models for data recording and analysis can also greatly broaden data exchange, thus promoting a uniform management of CVD patients also useful for clinical research. This advance however requires a great organizational effort by both physicians and health institutions, as well as the overcoming of ethical problems. This narrative review aims at providing an update on the state-of-art knowledge in the area of Systems Medicine as applied to CVD, focusing on current critical issues, providing a road map for its practical implementation. Copyright © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

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.

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...

Process Improvement for Interinstitutional Research Contracting.

Science.gov (United States)

Varner, Michael; Logan, Jennifer; Bjorklund, Todd; Whitfield, Jesse; Reed, Peggy; Lesher, Laurie; Sikalis, Amy; Brown, Brent; Drollinger, Sandy; Larrabee, Kristine; Thompson, Kristie; Clark, Erin; Workman, Michael; Boi, Luca

2015-08-01

Sponsored research increasingly requires multiinstitutional collaboration. However, research contracting procedures have become more complicated and time consuming. The perinatal research units of two colocated healthcare systems sought to improve their research contracting processes. The Lean Process, a management practice that iteratively involves team members in root cause analyses and process improvement, was applied to the research contracting process, initially using Process Mapping and then developing Problem Solving Reports. Root cause analyses revealed that the longest delays were the individual contract legal negotiations. In addition, the "business entity" was the research support personnel of both healthcare systems whose "customers" were investigators attempting to conduct interinstitutional research. Development of mutually acceptable research contract templates and language, chain of custody templates, and process development and refinement formats decreased the Notice of Grant Award to Purchase Order time from a mean of 103.5 days in the year prior to Lean Process implementation to 45.8 days in the year after implementation (p = 0.004). The Lean Process can be applied to interinstitutional research contracting with significant improvement in contract implementation. © 2015 Wiley Periodicals, Inc.

Maintaining clinical tissue archives and supporting human research: challenges and solutions.

Science.gov (United States)

Giannini, Caterina; Oelkers, Michael M; Edwards, William D; Aubry, Marie Christine; Muncil, Maureen M; Mohamud, Koshin H; Sandleback, Sara G; Nowak, John M; Bridgeman, Andrew; Brown, Marie E; Cheville, John C

2011-03-01

The increasing number of requests for use of clinically archived tissue in translational research poses unique challenges. Conflicts may arise between pathologists who are responsible for overseeing and preserving the tissues and investigators who need these materials for research purposes. To evaluate the status of our institution's Tissue Registry Archive and to develop updated written policies and procedures to support a new modern and robust tracking system with features of a library loan system. An observational study was performed. We found the existing process for managing loans of tissue (slides and paraffin blocks) to be insufficient for the complexity and volume of this task. After extensive customization, a new tracking system was implemented in January 2008. Analysis of the first year of the system's use (2008) showed that of the 206,330 slides and 51,416 blocks loaned out in 2008, 92% and 94%, respectively, were returned by the due date. These rates were markedly improved from those before the new system: 61% and 47%, respectively, in 2005. Material permanently "lost" in 2008 represented only 0.02% of slides and 0.05% of blocks, none of which was the only diagnostic material for the case. With expanding needs for archived tissues for clinical care and growing demands for translational research, it is essential that pathology departments at institutions with large tissue-based research endeavors have a tracking and management system in place to meet clinical, educational, and research needs, as well as legal requirements.

Regulatory aspects of the non-clinical researches in the Isotope Center

International Nuclear Information System (INIS)

Castro Alfonso, Yusniel

2017-01-01

For the quality control of radiopharmaceuticals produced by Centis and in pharmacokinetic studies carried out in this institution, scintigraphic images of animals are obtained. This allows the assessment of the distribution and behavior of these radiolabeled molecules inside the organism in order to use them in clinical trials in people having different pathologies. Besides following the CNSN regulations involving work with open radioactive sources, non-clinical research laboratory areas are subject to Biosafety Regulations particularly those established by Cecmed. The world trend to integrate the management systems in the organization processes requires the harmonization of Good Laboratory Practices, the compliance with Biosafety Regulations and International Standards concerning the ethics, when working with laboratory animals. This kind of laboratory coordinates its services directly with institutions developing drugs and with the Department of Quality Control for Products used in Nuclear Medicine in Centis. The present work is aimed at assessing the legislation and regulations related with non-clinical research area to take actions intended to improve the integrated management of biosafety for structuring a safety program. (author)

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.

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.

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

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.

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.)

DEVELOPING AN IPAD® APPLICATION FOR DATA COLLECTION IN A RHEUMATOLOGY RESEARCH CLINIC.

Science.gov (United States)

Kaka, Hussam; Ayearst, Renise; Tran, Maithy; Touma, Zahi; Bagovich, Maria; Vinik, Ophir; Somaily, Mansour; Haddad, Amir; Gladman, Dafna D; Chandran, Vinod

2015-01-01

Clinical research data are often collected on paper and later inputted onto an electronic database. This method is time consuming and potentially introduces errors. Therefore, to make primary data collection more efficient and less error prone we aimed to develop a touch-screen application for data collection in a psoriatic arthritis research clinic and compared it with the pre-existing paper-based system. We developed a Web application using Java and optimized it for the iPad®. It highlights missing fields for physicians in real time, and only permits submission of data collection form after corrections are made. For its evaluation, seven physicians participated, and before each patient visit they were randomly assigned paper or iPad® data entry. Number of errors, length of visit, and time between clinic visit and completion of data entry were measured. A total of 106 patients seen in the clinic who agreed to participate were randomly assigned to be evaluated by clinic physicians using the iPad® (fifty-three patients) or a paper protocol (fifty-three patients). On average, 3.34 omissions were found per paper form, of which 2.24 would have been detected on the iPad®. The iPad® increased the mean patient encounter time from 37.2 minutes to 46.5 minutes, but eliminated delay between a clinic visit and its data entry. Entering data using the iPad® application makes the patient encounter slightly longer, but reduces "missing fields." It also eliminates the delay between clinic visit and data entry thus improving the efficiency of clinical data capture in a research setting.

Continuous quality improvement for the clinical decision unit.

Science.gov (United States)

Mace, Sharon E

2004-01-01

Clinical decision units (CDUs) are a relatively new and growing area of medicine in which patients undergo rapid evaluation and treatment. Continuous quality improvement (CQI) is important for the establishment and functioning of CDUs. CQI in CDUs has many advantages: better CDU functioning, fulfillment of Joint Commission on Accreditation of Healthcare Organizations mandates, greater efficiency/productivity, increased job satisfaction, better performance improvement, data availability, and benchmarking. Key elements include a database with volume indicators, operational policies, clinical practice protocols (diagnosis specific/condition specific), monitors, benchmarks, and clinical pathways. Examples of these important parameters are given. The CQI process should be individualized for each CDU and hospital.

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...

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.

Animal models of osteogenesis imperfecta: applications in clinical research

Directory of Open Access Journals (Sweden)

Enderli TA

2016-09-01

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

Current Status of Clinical and Experimental Researches on Cognitive Impairment in Diabetes

Institute of Scientific and Technical Information of China (English)

无

2006-01-01

This article reviews the clinical and experimental researches on cognitive impairment related to diabetes in the recent decade. Most clinical studies indicate that the cognitive impairment in patients with type 1 diabetes mellitus is related to recurrent hypoglycemia closely. There is little research about whether or not hyperglycemia is related to cognitive impairment in patients with type 1 diabetes mellitus. Most studies indicate that the cognitive impairment in type 2 diabetes involves multiple factors through multiple mechanisms, including blood glucose, blood lipid, blood pressure, level of insulin, medication, chronic complication, etc. But, there has been no large-scale, multi-center, randomized controlled clinical trial in China recently. And what is more, some problems exist in this field of research, such as the lack of golden criterion of cognitive function measurement, different population of studied objects, and incomprehensive handling of confounding factors. Experimental studies found that hippocampal long-term potentiation (LTP) was impaired,which were manifested by impairment of spatial memory and decreased expression of LTP, but its relation to hyperglycemia, the duration of diabetes, learning and memory has always been differently reported by different researches. Thus, there are a lot of unknown things to be explored and studied in order to clarify its mechanism. TCM has abundant clinical experience in treating cerebral disease with medicine that enforces the kidney and promotes wit. However, there has been no research on treating diabetic cognitive impairment,which requires work to be done actively and TCM to be put into full play, in order to improve the treatment of diabetes and enhance living quality of patients.

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

Bridging the Measurement Gap Between Research and Clinical Care in Schizophrenia

DEFF Research Database (Denmark)

Østergaard, Søren D; Opler, Mark G A; Correll, Christoph U

2017-01-01

studies suggest that the much briefer PANSS-6 is a psychometrically valid measure of core positive and negative symptoms of schizophrenia and that the scale is sensitive to symptom improvement following pharmacological treatment. SNAPSI is a brief interview that yields the information needed to rate PANSS......There is currently a "measurement gap" between research and clinical care in schizophrenia. The main reason behind this gap is that the most widely used rating scale in schizophrenia research, the 30-item Positive and Negative Syndrome Scale (PANSS), takes so long to administer that it is rarely......-item PANSS in clinical practice; 2) how the brief, six-item version of the Positive and Negative Syndrome Scale (PANSS-6) was derived empirically from the full 30-item PANSS and what the initial results obtained with PANSS-6 entail; and 3) how PANSS-6 ratings, guided by the newly developed, 15...

Improved modeling of clinical data with kernel methods.

Science.gov (United States)

Daemen, Anneleen; Timmerman, Dirk; Van den Bosch, Thierry; Bottomley, Cecilia; Kirk, Emma; Van Holsbeke, Caroline; Valentin, Lil; Bourne, Tom; De Moor, Bart

2012-02-01

Despite the rise of high-throughput technologies, clinical data such as age, gender and medical history guide clinical management for most diseases and examinations. To improve clinical management, available patient information should be fully exploited. This requires appropriate modeling of relevant parameters. When kernel methods are used, traditional kernel functions such as the linear kernel are often applied to the set of clinical parameters. These kernel functions, however, have their disadvantages due to the specific characteristics of clinical data, being a mix of variable types with each variable its own range. We propose a new kernel function specifically adapted to the characteristics of clinical data. The clinical kernel function provides a better representation of patients' similarity by equalizing the influence of all variables and taking into account the range r of the variables. Moreover, it is robust with respect to changes in r. Incorporated in a least squares support vector machine, the new kernel function results in significantly improved diagnosis, prognosis and prediction of therapy response. This is illustrated on four clinical data sets within gynecology, with an average increase in test area under the ROC curve (AUC) of 0.023, 0.021, 0.122 and 0.019, respectively. Moreover, when combining clinical parameters and expression data in three case studies on breast cancer, results improved overall with use of the new kernel function and when considering both data types in a weighted fashion, with a larger weight assigned to the clinical parameters. The increase in AUC with respect to a standard kernel function and/or unweighted data combination was maximum 0.127, 0.042 and 0.118 for the three case studies. For clinical data consisting of variables of different types, the proposed kernel function--which takes into account the type and range of each variable--has shown to be a better alternative for linear and non-linear classification problems

Improving University Research Value

Directory of Open Access Journals (Sweden)

Kelley O’Reilly

2012-07-01

Full Text Available This article investigates the current data management practices of university researchers at an Intermountain West land-grant research university in the United States. Key findings suggest that researchers are primarily focused on the collection and housing of research data. However, additional research value exists within the other life cycle stages for research data—specifically in the stages of delivery and maintenance. These stages are where most new demands and requirements exist for data management plans and policies that are conditional for external grant funding; therefore, these findings expose a “gap” in current research practice. These findings should be of interest to academics and practitioners alike as findings highlight key management gaps in the life cycle of research data. This study also suggests a course of action for academic institutions to coalesce campus-wide assets to assist researchers in improving research value.

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.

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...

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.

The Electronic Healthcare Record for Clinical Research (EHR4CR) information model and terminology.

Science.gov (United States)

Ouagne, David; Hussain, Sajjad; Sadou, Eric; Jaulent, Marie-Christine; Daniel, Christel

2012-01-01

A major barrier to repurposing routinely collected data for clinical research is the heterogeneity of healthcare information systems. Electronic Healthcare Record for Clinical Research (EHR4CR) is a European platform designed to improve the efficiency of conducting clinical trials. In this paper, we propose an initial architecture of the EHR4CR Semantic Interoperability Framework. We used a model-driven engineering approach to build a reference HL7-based multidimensional model bound to a set of reference clinical terminologies acting as a global as view model. We then conducted an evaluation of its expressiveness for patient eligibility. The EHR4CR information model consists in one fact table dedicated to clinical statement and 4 dimensions. The EHR4CR terminology integrates reference terminologies used in patient care (e.g LOINC, ICD-10, SNOMED CT, etc). We used the Object Constraint Language (OCL) to represent patterns of eligibility criteria as constraints on the EHR4CR model to be further transformed in SQL statements executed on different clinical data warehouses.

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.

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

Science.gov (United States)

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

2017-06-01

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

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...

Current status and future prospect of radiation exposure to research volunteers in institutes with nuclear medicine. The report of questionnaires regarding radiation exposures to volunteers in clinical researches and clinical trials

International Nuclear Information System (INIS)

2010-01-01

There has been no guide of authorized radiological protection system in Japan when volunteers receive radionuclide administration in clinical research or phase I - IV studies. The purpose of this report was to depict issues on institutional radiological protection system for establishing the guide. We accumulated full-filled questionnaires regarding institutional radiological protection system of human subjects in 82 hospitals in which clinical researches or phase I - IV studies underwent to be subjected to radionuclide administrated volunteers in recent two years. We analyzed regarding (1) research content, (2) what committee approval of research using radionuclide administrated volunteer, (3) selection of the volunteers, (4) regulatory dose of administrated radionuclide, and (5) informed consent. Normal volunteers are subjected in clinical researches as well as phase-I study and microdose study. The researches subjected to normal volunteers needed with approval of institutional ethic committee in 64 (78%) hospitals, others than ethic committee in 9 (10%), and unknown in 2 (2%). In remaining 7 (8%), both ethic and other committees were described. No one with radiological knowledge included the committees in 23 hospitals (28%), of 15 had no consultation system regarding radiological protection. In all hospitals, regulatory dose in human subjects is less than 50 mSv and sufficient informed consent regarding the protection was obtained. In Japan, researches subjected to radionuclide administrated volunteers are performed by authorization of institutional ethic committees. Administrated radionuclide dose in them are less than upper limits of regulatory system of ICRP, USA and England because the committees include physicians, technologists and pharmaceutics with knowledge of radiological protection. But some hospitals have no committees authorize the research because they have no idea of authorized committees or cannot establish the committees. We recommend that

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...

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

Science.gov (United States)

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

2017-02-01

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

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.

A translation table for patient-centered comparative effectiveness research: guidance to improve the value of research for clinical and health policy decision-making.

Science.gov (United States)

Tunis, Sean R; Messner, Donna A; Mohr, Penny; Gliklich, Richard E; Dubois, Robert W

2012-05-01

This article provides background and context for a series of papers stemming from a collaborative effort by Outcome Sciences, Inc., the National Pharmaceutical Council and the Center for Medical Technology Policy to use a stakeholder-driven process to develop a decision tool to select appropriate methods for comparative effectiveness research. The perceived need and origins of the 'translation table' concept for method selection are described and the legislative history and role of the Patient-Centered Outcomes Research Institute are reviewed. The article concludes by stressing the significance of this effort for future health services and clinical research, and the importance of consulting end-users--patients, providers, payers and policy-makers--in the process of defining research questions and approaches to them.

77 FR 41188 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Science.gov (United States)

2012-07-12

... to general issues related to improvement in clinical laboratory quality and laboratory medicine... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical... patient-centeredness of laboratory services; revisions to the standards under which clinical laboratories...

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...

Online social networks for patient involvement and recruitment in clinical research.

Science.gov (United States)

Ryan, Gemma Sinead

2013-01-01

To review current literature and discuss the potential of online social networking to engage patients and the public and recruit and retain participants in clinical research. Online social networking is becoming a large influence on people's daily lives. Clinical research faces several challenges, with an increasing need to engage with patients and the public and for studies to recruit and retain increasing numbers of participants, particularly in under-served, under-represented and hard to reach groups and communities. Searches were conducted using EMBASE, BNI, ERIC, CINAHL, PSYCHinfo online databases and Google Scholar to identify any grey or unpublished literature that may be available. Review methods This is a methodology paper. Online social networking is a successful, cost-effective and efficient method by which to target and recruit a wide range of communities, adolescents, young people and underserved populations into quantitative and qualitative research. Retention of participants in longitudinal studies could be improved using social networks such as Facebook. Evidence indicates that a mixed approach to recruitment using social networking and traditional methods is most effective. Further research is required to strengthen the evidence available, especially in dissemination of research through online social networks. Researchers should consider using online social networking as a method of engaging the public, and also for the recruitment and follow up of participants.

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.

Five-year review of an international clinical research-training program

Science.gov (United States)

Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben MW; Fregni, Felipe

2015-01-01

The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008–2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background. PMID:25878518

Five-year review of an international clinical research-training program.

Science.gov (United States)

Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; Dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben Mw; Fregni, Felipe

2015-01-01

The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008-2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background.

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.

Does clinical supervision of healthcare professionals improve effectiveness of care and patient experience? A systematic review.

Science.gov (United States)

Snowdon, David A; Leggat, Sandra G; Taylor, Nicholas F

2017-11-28

To ensure quality of care delivery clinical supervision has been implemented in health services. While clinical supervision of health professionals has been shown to improve patient safety, its effect on other dimensions of quality of care is unknown. The purpose of this systematic review is to determine whether clinical supervision of health professionals improves effectiveness of care and patient experience. Databases MEDLINE, PsychINFO, CINAHL, EMBASE and AMED were searched from earliest date available. Additional studies were identified by searching of reference lists and citation tracking. Two reviewers independently applied inclusion and exclusion criteria. The quality of each study was rated using the Medical Education Research Study Quality Instrument. Data were extracted on effectiveness of care (process of care and patient health outcomes) and patient experience. Seventeen studies across multiple health professions (medical (n = 4), nursing (n = 7), allied health (n = 2) and combination of nursing, medical and/or allied health (n = 4)) met the inclusion criteria. The clinical heterogeneity of the included studies precluded meta-analysis. Twelve of 14 studies investigating 38,483 episodes of care found that clinical supervision improved the process of care. This effect was most predominant in cardiopulmonary resuscitation and African health settings. Three of six studies investigating 1756 patients found that clinical supervision improved patient health outcomes, namely neurological recovery post cardiopulmonary resuscitation (n = 1) and psychological symptom severity (n = 2). None of three studies investigating 1856 patients found that clinical supervision had an effect on patient experience. Clinical supervision of health professionals is associated with effectiveness of care. The review found significant improvement in the process of care that may improve compliance with processes that are associated with enhanced patient health

Engaged Research in Process Improvement

DEFF Research Database (Denmark)

Pries-Heje, Jan

2010-01-01

This keynote initiates from an example of engaged research; a Danish software house that made it from maturity level 1 to 5 in eight years. The organizational change implied at each step is discussed and a design theory of process improvement and change derived.......This keynote initiates from an example of engaged research; a Danish software house that made it from maturity level 1 to 5 in eight years. The organizational change implied at each step is discussed and a design theory of process improvement and change derived....

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

Improving Defense Health Program Medical Research Processes

Science.gov (United States)

2017-08-08

research , including a Business Cell; 87 Research Development, 88 Research Oversight, 89 and Research Compliance offices;90 and the Center...needed for DHP medical research , such as the Army’s Clinical and Translational Research Program Office, 38 the Navy’s Research Methods Training Program... research stated, “key infrastructure for a learning health system will encompass three core elements: data networks, methods , and workforce.” 221

Basic and clinical research advances in ischemic stroke

Directory of Open Access Journals (Sweden)

Yuan-yuan MA

2018-01-01

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

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

Three-dimensional (3D) culture in sarcoma research and the clinical significance.

Science.gov (United States)

Gao, Songtao; Shen, Jacson; Hornicek, Francis; Duan, Zhenfeng

2017-08-03

Sarcomas are rare malignant tumors that arise from transformed cells of mesenchymal origin. Despite the progress in diagnosis and treatment, sarcomas have a high mortality rate due to local recurrence, metastasis, and the development of drug resistance to chemotherapy. New models for sarcoma research are required to further understand the disease and to develop new therapies. In vitro sarcoma modeling is challenging because of significant genetic heterogeneities, diverse pathological, and overlapping clinical characteristics. Studies on the mechanisms of recurrence, metastasis, and drug resistance in sarcoma have resulted in the generation of novel three-dimensional (3D) culture models for sarcoma research. 3D culture models aim to recapitulate the tumor microenvironment that plays a critical role in the pathogenesis of sarcoma using biomaterial scaffolds of natural biological materials and artificial polymers. An ideal 3D culture model can properly mimic not only the microenvironment, oncogenesis, and maintenance of sarcoma cell growth, but also imitate the interactions between cells and to the extracellular matrix. More recently, 3D cell culture has been used to research the biological behavior and mechanism of chemotherapy and radiotherapy resistance in different sarcoma models. Ultimately, findings using 3D models that more accurately reflect human sarcoma biology are likely to translate into improved clinical outcomes. In this review, we discuss the most recent advances of 3D culture technologies in sarcoma research and emerging clinical applications.

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.

Auditing of clinical research ethics in a children's and women's academic hospital.

Science.gov (United States)

Bortolussi, Robert; Nicholson, Diann

2002-06-01

Canadian and international guidelines for research ethics practices have advocated that research ethics boards (REBs) should implement mechanisms to review and monitor human research. Despite this, few Canadian REBs fulfil this expectation. The objective of this report is to summarize the results of 6 audits of clinical research ethics conducted between 1992 and 2000 in a children's and women's academic hospital in Canada in an effort to guide other academic centres planning a similar process. Research audits were conducted by members of a research audit review committee made up of REB volunteers. With use of random and selective processes, approximately 10% of research protocols were audited through interviews with research investigators and research coordinators and by sampling research records. Predetermined criteria were used to assess evidence of good record keeping, data monitoring, adherence to protocol, consents and the recording of adverse events during the research study. An estimate of time required to undertake an audit was made by recall of participants and records. Thirty-five research studies were reviewed including 16 multicentre clinical trials and 19 single-site clinical studies. Review of record keeping and research practice revealed some deficiencies: researchers failed to maintain original authorization (7%) or renewal documentation (9%); there was 1 instance of improper storage of medication; in 5% of 174 participants for whom consent was reviewed, an outdated consent form had been used, and in 4% the signature of the enrolee was not properly shown. Other deficiencies in consent documentation occurred in less than 2% of cases. Nineteen recommendations were made with respect to deficiencies and process issues. A total of 9 to 20 person-hours are required to review each protocol in a typical audit of this type. Information from research audits has been useful to develop educational programs to correct deficiencies identified through the audits

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.

Clinical data miner: an electronic case report form system with integrated data preprocessing and machine-learning libraries supporting clinical diagnostic model research.

Science.gov (United States)

Installé, Arnaud Jf; Van den Bosch, Thierry; De Moor, Bart; Timmerman, Dirk

2014-10-20

Using machine-learning techniques, clinical diagnostic model research extracts diagnostic models from patient data. Traditionally, patient data are often collected using electronic Case Report Form (eCRF) systems, while mathematical software is used for analyzing these data using machine-learning techniques. Due to the lack of integration between eCRF systems and mathematical software, extracting diagnostic models is a complex, error-prone process. Moreover, due to the complexity of this process, it is usually only performed once, after a predetermined number of data points have been collected, without insight into the predictive performance of the resulting models. The objective of the study of Clinical Data Miner (CDM) software framework is to offer an eCRF system with integrated data preprocessing and machine-learning libraries, improving efficiency of the clinical diagnostic model research workflow, and to enable optimization of patient inclusion numbers through study performance monitoring. The CDM software framework was developed using a test-driven development (TDD) approach, to ensure high software quality. Architecturally, CDM's design is split over a number of modules, to ensure future extendability. The TDD approach has enabled us to deliver high software quality. CDM's eCRF Web interface is in active use by the studies of the International Endometrial Tumor Analysis consortium, with over 4000 enrolled patients, and more studies planned. Additionally, a derived user interface has been used in six separate interrater agreement studies. CDM's integrated data preprocessing and machine-learning libraries simplify some otherwise manual and error-prone steps in the clinical diagnostic model research workflow. Furthermore, CDM's libraries provide study coordinators with a method to monitor a study's predictive performance as patient inclusions increase. To our knowledge, CDM is the only eCRF system integrating data preprocessing and machine-learning libraries

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)

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

Science.gov (United States)

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

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

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.

Automation of CT-based haemorrhagic stroke assessment for improved clinical outcomes: study protocol and design.

Science.gov (United States)

Chinda, Betty; Medvedev, George; Siu, William; Ester, Martin; Arab, Ali; Gu, Tao; Moreno, Sylvain; D'Arcy, Ryan C N; Song, Xiaowei

2018-04-19

scientists, computing scientists and clinical professionals in neurology and neuroradiology and includes patient representatives. Research outputs will be disseminated following knowledge translation plans towards improving stroke patient care. Significant findings will be published in scientific journals. Anticipated deliverables include computer solutions for improved clinical assessment of haematoma using NCCT. © 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.

Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

Science.gov (United States)

Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C; Farrar, John T; Fillingim, Roger B; Gilron, Ian; Markman, John D; Oaklander, Anne Louise; Polydefkis, Michael J; Raja, Srinivasa N; Robinson, James P; Woolf, Clifford J; Ziegler, Dan; Ashburn, Michael A; Burke, Laurie B; Cowan, Penney; George, Steven Z; Goli, Veeraindar; Graff, Ole X; Iyengar, Smriti; Jay, Gary W; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A; Kopecky, Ernest A; Malamut, Richard; McDermott, Michael P; Palmer, Pamela; Rappaport, Bob A; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A

2015-07-01

Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

Common data elements for clinical research in mitochondrial disease: a National Institute for Neurological Disorders and Stroke project

NARCIS (Netherlands)

Karaa, A.; Rahman, S.; Lombes, A.; Yu-Wai-Man, P.; Sheikh, M.K.; Alai-Hansen, S.; Cohen, B.H.; Dimmock, D.; Emrick, L.; Falk, M.J.; McCormack, S.; Mirsky, D.; Moore, T.; Parikh, S.; Shoffner, J.; Taivassalo, T.; Tarnopolsky, M.; Tein, I.; Odenkirchen, J.C.; Goldstein, A.; Koene, S.; Smeitink, J.A.M.; et al.,

2017-01-01

OBJECTIVES: The common data elements (CDE) project was developed by the National Institute of Neurological Disorders and Stroke (NINDS) to provide clinical researchers with tools to improve data quality and allow for harmonization of data collected in different research studies. CDEs have been

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...

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

Science.gov (United States)

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

2016-02-01

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

Medical simulation-based education improves medicos' clinical skills.

Science.gov (United States)

Wang, Zhaoming; Liu, Qiaoyu; Wang, Hai

2013-03-01

Clinical skill is an essential part of clinical medicine and plays quite an important role in bridging medicos and physicians. Due to the realities in China, traditional medical education is facing many challenges. There are few opportunities for students to practice their clinical skills and their dexterities are generally at a low level. Medical simulation-based education is a new teaching modality and helps to improve medicos' clinical skills to a large degree. Medical simulation-based education has many significant advantages and will be further developed and applied.

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.

Clinical priorities, barriers and solutions in end-of-life cancer care research across Europe. Report from a workshop

DEFF Research Database (Denmark)

Sigurdardottir, Katrin Ruth; Haugen, Dagny Faksvåg; van der Rijt, Carin C D

2010-01-01

The PRISMA project is aiming to co-ordinate research priorities, measurement and practice in end-of-life (EOL) care in Europe. As part of PRISMA we undertook a questionnaire survey and a subsequent workshop to (1) identify clinical priorities for EOL care research in Europe and propose a future...... research agenda and (2) identify barriers to EOL care research, and possibilities and solutions to improve the research....

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 ...

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.

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...

Clinical Research Environment in India: Challenges and Proposed Solutions.

Science.gov (United States)

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

2014-11-01

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

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.

Are researcher development interventions, alone or in any combination, effective in improving researcher behavior? A systematic review.

Science.gov (United States)

Mazmanian, Paul E; Coe, Antoinette B; Evans, Jessica A; Longo, Daniel R; Wright, Barbara A

2014-03-01

Academic institutions funded by the Clinical and Translational Science Awards (CTSA) Program of the National Institutes of Health were challenged recently by the Institute of Medicine to expand traditional mentoring of graduate and postdoctoral scholars to include training and continuing education for faculty, professional staff, and community partners. A systematic review was conducted to determine whether researcher development interventions, alone or in any combination, are effective in improving researcher behavior. PubMed, CINAHL, and Education Research Complete databases and select journals were searched for relevant articles published from January 2000 through October 2012. A total of 3,459 papers were identified, and 114 papers were retrieved for in-depth analysis. None included randomization. Twenty-two papers reported subjects with professional degrees, interventions, and outcomes. Interventions were meetings, outreach visits, colleague mediation, audit and feedback, and multifaceted interventions. Most studies reported multifaceted interventions (68.2%), often involving mentored learning experiences, and meetings. All studies reported a change in performance, including numbers of publications or grant applications. Nine studies reported changes in competence, including writing, presentation, or analytic skills, and performance in research practice (40.9%). Even as, the quality of evidence was weak to establish causal linkages between researcher development and improved researcher behavior, nearly all the projects (81.8%) received funding from governmental agencies, professional societies, or other organizations. Those who design researcher development activities and those who evaluate the programs are challenged to develop tools and conduct studies that measure the effectiveness, costs, and sustainability of researcher development in the CTSA Program.

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

Improving pediatric immunization rates: description of a resident-led clinical continuous quality improvement project.

Science.gov (United States)

Jones, Kyle Bradford; Gren, Lisa H; Backman, Richard

2014-09-01

Increased emphasis is being placed on the continuous quality improvement (CQI) education of residents of all specialties. This article describes a resident-led continuous quality improvement (CQI) project, based on a novel curriculum, to improve the immunization rates of children under 2 years old at the Madsen Family Health Center (MHC). All third-year residents were trained in the FOCUS-PDSA CQI methodology through concurrent didactic lectures and experience leading the CQI team. The CQI team included clinical staff led by a third-year family medicine resident and mentored by a member of the family medicine faculty. Immunization records were distributed to provider-medical assistant teamlets daily for each pediatric patient scheduled in clinic as the intervention. Compliance with the intervention (process measure), as well as immunization rates at 2 and 5 months post-intervention (outcome measure), were monitored. Immunization records were printed on 84% of clinic days from October 24, 2011 to March 31, 2012. The percentage of patients immunized at baseline was 66%. The percentage immunized as of December 31, 2011 was 96% and was 91% as of March 31, 2012. An important educational experience was organized for third-year family medicine residents through learning CQI skills, leading a CQI team, and directing a CQI project to completion. Significant improvement in the percentage of patients under 2 years old immunized at the MHC was achieved by presenting provider-medical assistant teamlets with immunization records of all pediatric patients on the daily clinic schedule.

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.

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

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

Clinical research in small genomically stratified patient populations.

Science.gov (United States)

Martin-Liberal, J; Rodon, J

2017-07-01

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

TIAM1 variants improve clinical outcome in neuroblastoma.

Science.gov (United States)

Sanmartín, Elena; Yáñez, Yania; Fornés-Ferrer, Victoria; Zugaza, José L; Cañete, Adela; Castel, Victoria; Font de Mora, Jaime

2017-07-11

Identification of tumor driver mutations is crucial for improving clinical outcome using a personalized approach to the treatment of cancer. Neuroblastoma is a tumor of the peripheral sympathetic nervous system for which only a few driver alterations have been described including MYCN amplification and ALK mutations. We assessed 106 primary neuroblastoma tumors by next generation sequencing using a customized amplicon-based gene panel. Our results reveal that genetic variants in TIAM1 gene associate with better clinical outcome, suggesting a role for these TIAM1 variants in preventing progression of this disease. The detected variants are located within the different domains of TIAM1 that signal to the upstream regulator RAS and downstream effector molecules MYC and RAC, which are all implicated in neuroblastoma etiology and progression. Clinical outcome was improved in tumors where a TIAM1 variant was present concomitantly with either ALK mutation or MYCN amplification. Given the function of these signaling molecules in cell survival, proliferation, differentiation and neurite outgrowth, our data suggest that the TIAM1-mediated network is essential to neuroblastoma and thus, inhibiting TIAM1 reflects a rational strategy for improving therapy efficacy in neuroblastoma.

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...

Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research

Directory of Open Access Journals (Sweden)

Hanson Janice L

2012-11-01

Full Text Available Abstract Background There are no empirically-grounded criteria or tools to define or benchmark the quality of outpatient clinical documentation. Outpatient clinical notes document care, communicate treatment plans and support patient safety, medical education, medico-legal investigations and reimbursement. Accurately describing and assessing quality of clinical documentation is a necessary improvement in an increasingly team-based healthcare delivery system. In this paper we describe the quality of outpatient clinical notes from the perspective of multiple stakeholders. Methods Using purposeful sampling for maximum diversity, we conducted focus groups and individual interviews with clinicians, nursing and ancillary staff, patients, and healthcare administrators at six federal health care facilities between 2009 and 2011. All sessions were audio-recorded, transcribed and qualitatively analyzed using open, axial and selective coding. Results The 163 participants included 61 clinicians, 52 nurse/ancillary staff, 31 patients and 19 administrative staff. Three organizing themes emerged: 1 characteristics of quality in clinical notes, 2 desired elements within the clinical notes and 3 system supports to improve the quality of clinical notes. We identified 11 codes to describe characteristics of clinical notes, 20 codes to describe desired elements in quality clinical notes and 11 codes to describe clinical system elements that support quality when writing clinical notes. While there was substantial overlap between the aspects of quality described by the four stakeholder groups, only clinicians and administrators identified ease of translation into billing codes as an important characteristic of a quality note. Only patients rated prioritization of their medical problems as an aspect of quality. Nurses included care and education delivered to the patient, information added by the patient, interdisciplinary information, and infection alerts as important

Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research.

Science.gov (United States)

Hanson, Janice L; Stephens, Mark B; Pangaro, Louis N; Gimbel, Ronald W

2012-11-19

There are no empirically-grounded criteria or tools to define or benchmark the quality of outpatient clinical documentation. Outpatient clinical notes document care, communicate treatment plans and support patient safety, medical education, medico-legal investigations and reimbursement. Accurately describing and assessing quality of clinical documentation is a necessary improvement in an increasingly team-based healthcare delivery system. In this paper we describe the quality of outpatient clinical notes from the perspective of multiple stakeholders. Using purposeful sampling for maximum diversity, we conducted focus groups and individual interviews with clinicians, nursing and ancillary staff, patients, and healthcare administrators at six federal health care facilities between 2009 and 2011. All sessions were audio-recorded, transcribed and qualitatively analyzed using open, axial and selective coding. The 163 participants included 61 clinicians, 52 nurse/ancillary staff, 31 patients and 19 administrative staff. Three organizing themes emerged: 1) characteristics of quality in clinical notes, 2) desired elements within the clinical notes and 3) system supports to improve the quality of clinical notes. We identified 11 codes to describe characteristics of clinical notes, 20 codes to describe desired elements in quality clinical notes and 11 codes to describe clinical system elements that support quality when writing clinical notes. While there was substantial overlap between the aspects of quality described by the four stakeholder groups, only clinicians and administrators identified ease of translation into billing codes as an important characteristic of a quality note. Only patients rated prioritization of their medical problems as an aspect of quality. Nurses included care and education delivered to the patient, information added by the patient, interdisciplinary information, and infection alerts as important content. Perspectives of these four stakeholder

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...

A guide to radiological research. The Research Sub-Committee of the Board of the Faculty of Clinical Radiology, the Royal College of Radiologists

International Nuclear Information System (INIS)

1997-11-01

There are broad categories of radiological research. Basic science research undertaken in universities or in manufacturing companies may lead to new techniques or even new products like MRI, CT or contrast media. MRI is a product of university based research, while CT developed within a manufacturing company. Basic science type research is vital for the continuing development of our speciality, but requires considerable resources, teamwork, and research/management expertise. The best place for an interested radiologist to learn such skills is within university departments, typically in the context of an MD, Ph.D. or similar degree course. Clinical radiological research is of equal importance and, in the UK, underpins our international reputation for radiological excellence. Clinical research may be defined as research requiring patients. It can therefore only be carried out in hospitals and clinics. New technologies, drugs, indications, procedures etc., all require clinical research to validate them. The role of the clinical radiologist is pivotal to the proper conduct of clinical imaging research and technology assessment. This is not confined to university and teaching centres, but is of equal importance in district general hospitals. Results from clinical research carried out 'in the field' are the true test of our specialty. This research guide is sponsored by the RCR. Its target is radiologists and others carrying out clinical research within departments of radiology. If it stimulates Fellows and Members of the RCR to conduct more and better research then it will have succeeded in its basic objective. Research is always planned. It is based on observation, measurement and the testing of ideas or hypotheses. It is presented to peers for criticism and then published to be available to all for review. Research is always hard work and requires discipline. Like many things the ability to conduct research improves with practice. Many radiologists have not had much

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)

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.

High hospital research participation and improved colorectal cancer survival outcomes: a population-based study.

Science.gov (United States)

Downing, Amy; Morris, Eva Ja; Corrigan, Neil; Sebag-Montefiore, David; Finan, Paul J; Thomas, James D; Chapman, Michael; Hamilton, Russell; Campbell, Helen; Cameron, David; Kaplan, Richard; Parmar, Mahesh; Stephens, Richard; Seymour, Matt; Gregory, Walter; Selby, Peter

2017-01-01

In 2001, the National Institute for Health Research Cancer Research Network (NCRN) was established, leading to a rapid increase in clinical research activity across the English NHS. Using colorectal cancer (CRC) as an example, we test the hypothesis that high, sustained hospital-level participation in interventional clinical trials improves outcomes for all patients with CRC managed in those research-intensive hospitals. Data for patients diagnosed with CRC in England in 2001-2008 (n=209 968) were linked with data on accrual to NCRN CRC studies (n=30 998). Hospital Trusts were categorised by the proportion of patients accrued to interventional studies annually. Multivariable models investigated the relationship between 30-day postoperative mortality and 5-year survival and the level and duration of study participation. Most of the Trusts achieving high participation were district general hospitals and the effects were not limited to cancer 'centres of excellence', although such centres do make substantial contributions. Patients treated in Trusts with high research participation (≥16%) in their year of diagnosis had lower postoperative mortality (presearch participation, with a reduction in postoperative mortality of 1.5% (6.5%-5%, pstudies for all patients with CRC treated in the hospital study participants. Improvement precedes and increases with the level and years of sustained participation. 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/.

Horizon 2020 Priorities in Clinical Mental Health Research: Results of a Consensus-Based ROAMER Expert Survey

Directory of Open Access Journals (Sweden)

Iman Elfeddali

2014-10-01

Full Text Available Within the ROAMER project, which aims to provide a Roadmap for Mental Health Research in Europe, a two-stage Delphi survey among 86 European experts was conducted in order to identify research priorities in clinical mental health research. Expert consensus existed with regard to the importance of three challenges in the field of clinical mental health research: (1 the development of new, safe and effective interventions for mental disorders; (2 understanding the mechanisms of disease in order to be able to develop such new interventions; and (3 defining outcomes (an improved set of outcomes, including alternative outcomes to use for clinical mental health research evaluation. Proposed actions involved increasing the utilization of tailored approaches (personalized medicine, developing blended eHealth/mHealth decision aids/guidance tools that help the clinician to choose between various treatment modalities, developing specific treatments in order to better target comorbidity and (further development of biological, psychological and psychopharmacological interventions. The experts indicated that addressing these priorities will result in increased efficacy and impact across Europe; with a high probability of success, given that Europe has important strengths, such as skilled academics and a long research history. Finally, the experts stressed the importance of creating funding and coordinated networking as essential action needed in order to target the variety of challenges in clinical mental health research.

Processes for Quality Improvements in Radiation Oncology Clinical Trials

International Nuclear Information System (INIS)

FitzGerald, T.J.; Urie, Marcia; Ulin, Kenneth; Laurie, Fran; Yorty, Jeffrey C.; Hanusik, Richard; Kessel, Sandy; Jodoin, Maryann Bishop; Osagie, Gani; Cicchetti, M. Giulia; Pieters, Richard; McCarten, Kathleen; Rosen, Nancy

2008-01-01

Quality assurance in radiotherapy (RT) has been an integral aspect of cooperative group clinical trials since 1970. In early clinical trials, data acquisition was nonuniform and inconsistent and computational models for radiation dose calculation varied significantly. Process improvements developed for data acquisition, credentialing, and data management have provided the necessary infrastructure for uniform data. With continued improvement in the technology and delivery of RT, evaluation processes for target definition, RT planning, and execution undergo constant review. As we move to multimodality image-based definitions of target volumes for protocols, future clinical trials will require near real-time image analysis and feedback to field investigators. The ability of quality assurance centers to meet these real-time challenges with robust electronic interaction platforms for imaging acquisition, review, archiving, and quantitative review of volumetric RT plans will be the primary challenge for future successful clinical trials

Open Access Platforms in Spinal Cord Injury: Existing Clinical Trial Data to Predict and Improve Outcomes.

Science.gov (United States)

Kramer, John L K; Geisler, Fred; Ramer, Leanne; Plunet, Ward; Cragg, Jacquelyn J

2017-05-01

Recovery from acute spinal cord injury (SCI) is characterized by extensive heterogeneity, resulting in uncertain prognosis. Reliable prediction of recovery in the acute phase benefits patients and their families directly, as well as improves the likelihood of detecting efficacy in clinical trials. This issue of heterogeneity is not unique to SCI. In fields such as traumatic brain injury, Parkinson's disease, and amyotrophic lateral sclerosis, one approach to understand variability in recovery has been to make clinical trial data widely available to the greater research community. We contend that the SCI community should adopt a similar approach in providing open access clinical trial data.

Using digital multimedia to improve parents' and children's understanding of clinical trials.

Science.gov (United States)

Tait, Alan R; Voepel-Lewis, Terri; Levine, Robert

2015-06-01

Data show that many research subjects have difficulty understanding study information using traditional paper consent documents. This study, therefore, was designed to evaluate the effect of an interactive multimedia program on improving parents' and children's understanding of clinical trial concepts and participation. Parents (n=148) and children (n=135) were each randomised to receive information regarding clinical trials using either a traditional paper format (TF) or an interactive iPad program (IP) with inline exercises. Participants' understanding of the information was assessed using semistructured interviews prior to (pretest) and after (post-test) receiving the information. Participants also completed a short survey to assess their perceptions of information delivery and satisfaction with the process. Regardless of the mode of information delivery, all participants demonstrated improved pretest to post-test understanding. While there were no statistical differences in parents' post-test understanding between the TF and IP groups, children in the IP group had significantly greater post-test understanding compared with children in the TF group (11.65 (4.1) vs 8.85 (4.1) (2.8, 1.4, 4.2) 0-18 scale where 18=complete understanding). Furthermore, the IP was found to be significantly 'easier to follow' and 'more effective' in presenting information compared with the TF. Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children. Importantly, the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery, particularly among children, supports this approach as a novel and effective vehicle for enhancing the informed consent process. 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.

Quantitative research versus quality assurance, quality improvement, total quality management, and continuous quality improvement.

Science.gov (United States)

Vogelsang, J

1999-04-01

The purpose of this report is to provide a review of the scientific method used in the quantitative research studies for consumers, evaluators, and applied nurse researchers. The fundamental characteristics of the problem-solving/ performance-improvement processes of quality assurance, quality improvement, total quality management, and continuous quality improvement are described. Research is compared with these processes, and is followed by a discussion about the publication of quantitative research findings.

Analyzing the blood-brain barrier: the benefits of medical imaging in research and clinical practice.

Science.gov (United States)

Chassidim, Yoash; Vazana, Udi; Prager, Ofer; Veksler, Ronel; Bar-Klein, Guy; Schoknecht, Karl; Fassler, Michael; Lublinsky, Svetlana; Shelef, Ilan

2015-02-01

A dysfunctional BBB is a common feature in a variety of brain disorders, a fact stressing the need for diagnostic tools designed to assess brain vessels' permeability in space and time. Biological research has benefited over the years various means to analyze BBB integrity. The use of biomarkers for improper BBB functionality is abundant. Systemic administration of BBB impermeable tracers can both visualize brain regions characterized by BBB impairment, as well as lead to its quantification. Additionally, locating molecular, physiological content in regions from which it is restricted under normal BBB functionality undoubtedly indicates brain pathology-related BBB disruption. However, in-depth research into the BBB's phenotype demands higher analytical complexity than functional vs. pathological BBB; criteria which biomarker based BBB permeability analyses do not meet. The involvement of accurate and engineering sciences in recent brain research, has led to improvements in the field, in the form of more accurate, sensitive imaging-based methods. Improvements in the spatiotemporal resolution of many imaging modalities and in image processing techniques, make up for the inadequacies of biomarker based analyses. In pre-clinical research, imaging approaches involving invasive procedures, enable microscopic evaluation of BBB integrity, and benefit high levels of sensitivity and accuracy. However, invasive techniques may alter normal physiological function, thus generating a modality-based impact on vessel's permeability, which needs to be corrected for. Non-invasive approaches do not affect proper functionality of the inspected system, but lack in spatiotemporal resolution. Nevertheless, the benefit of medical imaging, even in pre-clinical phases, outweighs its disadvantages. The innovations in pre-clinical imaging and the development of novel processing techniques, have led to their implementation in clinical use as well. Specialized analyses of vessels' permeability

Expanding clinical research capacity through a community of practice (CoPER).

Science.gov (United States)

Short, Alison; Jackson, Wanda; Nugus, Peter

2010-01-01

The proposed CoPER project (Community of Practice for Engaging in Research) responds to a need for increased research capacity in a clinical setting. We put forward an argument and a design for a prospective action research project to extend research capacity via an integrated academic and practitioner community of practice in an Emergency Department (ED). This paper explores the research needs of clinicians, articulates the concept of community of practice in light of these needs, and outlines the rationale for considering communities of practice as a potential contributor to building research capacity in a clinical setting. A potential methodology is suggested to test the linkage between research needs, the concept of a community of practice model in a clinical setting, and the contribution of such a model to building research capacity in a clinical setting via the CoPER framework. Combined data from this proposed mixed method action research (survey, focus groups, interviews, observation) are expected to enable the production of a set of facilitators and enablers with a view to building a community of research practice which make the case study transferable to other clinical and non-clinical work settings.

Redesigning a clinical mentoring program for improved outcomes in the clinical training of clerks

OpenAIRE

Lin, Chia-Der; Lin, Blossom Yen-Ju; Lin, Cheng-Chieh; Lee, Cheng-Chun

2015-01-01

Introduction: Mentorship has been noted as critical to medical students adapting to clinical training in the medical workplace. A lack of infrastructure in a mentoring program might deter relationship building between mentors and mentees. This study assessed the effect of a redesigned clinical mentoring program from the perspective of clerks. The objective was to assess the benefits of the redesigned program and identify potential improvements.Methods: A redesigned clinical mentoring program ...

Development of an open metadata schema for prospective clinical research (openPCR) in China.

Science.gov (United States)

Xu, W; Guan, Z; Sun, J; Wang, Z; Geng, Y

2014-01-01

terms in Chinese EHR Standard. Archetypes in openPCR are modularity models and can be separated, recombined, and reused. The authors recommend that the method to develop openPCR can be referenced by other countries when designing metadata schema of clinical research. In the next steps, openPCR should be used in a number of CR projects to test its applicability and to continuously improve its coverage. Besides, metadata schema for research protocol can be developed to structurize and standardize protocol, and syntactical interoperability of openPCR with other related standards can be considered.

[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.

Advances in mass spectrometry-based cancer research and analysis: from cancer proteomics to clinical diagnostics.

Science.gov (United States)

Timms, John F; Hale, Oliver J; Cramer, Rainer

2016-06-01

The last 20 years have seen significant improvements in the analytical capabilities of biological mass spectrometry (MS). Studies using advanced MS have resulted in new insights into cell biology and the etiology of diseases as well as its use in clinical applications. This review discusses recent developments in MS-based technologies and their cancer-related applications with a focus on proteomics. It also discusses the issues around translating the research findings to the clinic and provides an outline of where the field is moving. Expert commentary: Proteomics has been problematic to adapt for the clinical setting. However, MS-based techniques continue to demonstrate potential in novel clinical uses beyond classical cancer proteomics.

It's Only a Phase: Applying the 5 Phases of Clinical Trials to the NSCR Model Improvement Process

Science.gov (United States)

Elgart, S. R.; Milder, C. M.; Chappell, L. J.; Semones, E. J.

2017-01-01

NASA limits astronaut radiation exposures to a 3% risk of exposure-induced death from cancer (REID) at the upper 95% confidence level. Since astronauts approach this limit, it is important that the estimate of REID be as accurate as possible. The NASA Space Cancer Risk 2012 (NSCR-2012) model has been the standard for NASA's space radiation protection guidelines since its publication in 2013. The model incorporates elements from U.S. baseline statistics, Japanese atomic bomb survivor research, animal models, cellular studies, and radiation transport to calculate astronaut baseline risk of cancer and REID. The NSCR model is under constant revision to ensure emerging research is incorporated into radiation protection standards. It is important to develop guidelines, however, to determine what new research is appropriate for integration. Certain standards of transparency are necessary in order to assess data quality, statistical quality, and analytical quality. To this effect, all original source code and any raw data used to develop the code are required to confirm there are no errors which significantly change reported outcomes. It is possible to apply a clinical trials approach to select and assess the improvement concepts that will be incorporated into future iterations of NSCR. This poster describes the five phases of clinical trials research, pre-clinical research, and clinical research phases I-IV, explaining how each step can be translated into an appropriate NSCR model selection guideline.

Characteristics of Volunteer Coaches in a Clinical Process Improvement Program.

Science.gov (United States)

Morley, Katharine E; Barysauskas, Constance M; Carballo, Victoria; Kalibatas, Orinta; Rao, Sandhya K; Jacobson, Joseph O; Cummings, Brian M

The Partners Clinical Process Improvement Leadership Program provides quality improvement training for clinicians and administrators, utilizing graduates as volunteer peer coaches for mentorship. We sought to understand the factors associated with volunteer coach participation and gain insight into how to improve and sustain this program. Review of coach characteristics from course database and survey of frequent coaches. Out of 516 Partners Clinical Process Improvement Leadership Program graduates from March 2010 to June 2015, 117 (23%) individuals volunteered as coaches. Sixty-one (52%) individuals coached once, 31 (27%) coached twice, and 25 (21%) coached 3 or more times. There were statistically significant associations between coaching and occupation (P = .005), Partners Clinical Process Improvement Leadership Program course taken (P = .001), and course location (P = .007). Administrators were more likely to coach than physicians (odds ratio: 1.75, P = .04). Reasons for volunteering as a coach included further development of skills, desire to stay involved with program, and enjoying mentoring. Reasons for repeated coaching included maintaining quality improvement skills, expanding skills to a wider variety of projects, and networking. A peer graduate volunteer coach model is a viable strategy for interprofessional quality improvement mentorship. Strategies that support repeat coaching and engage clinicians should be promoted to ensure an experienced and diversified group of coaches.