Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes.

PubMed

Lang, Niklaus P; Zitzmann, Nicola U

2012-02-01

The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.

How can we improve clinical research in pneumonia?

PubMed

Ramirez, Julio A

2018-05-01

The primary challenges in the field of clinical research include a lack of support within existing infrastructure, insufficient number of clinical research training programs and a paucity of qualified mentors. Most medical centers offer infrastructure support for investigators working with industry sponsors or government-funded clinical trials, yet there are a significant amount of clinical studies performed in the field of pneumonia which are observational studies. For this type of research, which is frequently unfunded, support is usually lacking. In an attempt to optimize clinical research in pneumonia, at the University of Louisville, we developed a clinical research coordinating center (CRCC). The center manages clinical studies in the field of respiratory infections, with the primary focus being pneumonia. Other activities of the CRCC include the organization of an annual clinical research training course for physicians and other healthcare workers, and the facilitation of international research mentoring by a process of connecting new pneumonia investigators with established clinical investigators. To improve clinical research in pneumonia, institutions need to have the appropriate infrastructure in place to support investigators in all aspects of the clinical research process.

Use of a Relational Database to Support Clinical Research: Application in a Diabetes Program

PubMed Central

Lomatch, Diane; Truax, Terry; Savage, Peter

1981-01-01

A database has been established to support conduct of clinical research and monitor delivery of medical care for 1200 diabetic patients as part of the Michigan Diabetes Research and Training Center (MDRTC). Use of an intelligent microcomputer to enter and retrieve the data and use of a relational database management system (DBMS) to store and manage data have provided a flexible, efficient method of achieving both support of small projects and monitoring overall activity of the Diabetes Center Unit (DCU). Simplicity of access to data, efficiency in providing data for unanticipated requests, ease of manipulations of relations, security and “logical data independence” were important factors in choosing a relational DBMS. The ability to interface with an interactive statistical program and a graphics program is a major advantage of this system. Out database currently provides support for the operation and analysis of several ongoing research projects.

Research Areas - Clinical Trials

Cancer.gov

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.

Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical research.

PubMed

Julé, Amélie; Furtado, Tamzin; Boggs, Liam; van Loggerenberg, Francois; Ewing, Victoria; Vahedi, Manhaz; Launois, Pascal; Lang, Trudie

2017-01-01

Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas-(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally.

Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical research

PubMed Central

Julé, Amélie; Boggs, Liam; van Loggerenberg, Francois; Ewing, Victoria; Vahedi, Manhaz; Launois, Pascal; Lang, Trudie

2017-01-01

Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas—(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally. PMID:28589027

[ECRIN (European clinical research infrastructures network), a pan-European infrastructure for clinical research].

PubMed

Demotes-Mainard, Jacques

2010-12-01

Clinical research plays a key role both in the development of innovative health products and in the optimisation of medical strategies, leading to evidence-based practice and healthcare cost containment. ECRIN is a distributed ESFRI-roadmap pan-European infrastructure designed to support multinational clinical research, making Europe a single area for clinical studies, taking advantage of its population size to access patients, and unlocking latent scientific providing services to multinational. Servicing of multinational trials started during the preparatory phase, and ECRIN has applied for ERIC status in 2011. In parallel, ECRIN has also proposed an FP7 integrating activity project to further develop, upgrade and expand the ECRIN infrastructure built up during the past FP6 and FP7 projects, facilitating an efficient organization of clinical research in Europe, with ECRIN developing generic tools and providing generic services for multinational studies, and supporting the construction of pan-European disease-oriented networks that will in turn act as ECRIN users. This organization will improve Europe's attractiveness for industry trials, boost its scientific competitiveness, and result in better healthcare for European citizens. The three medical areas supported in this project (rare diseases, medical devices, and nutrition) will serve as pilots for other biomedical research fields. By creating a single area for clinical research in Europe, this structure will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of research and educational capacities, tackling the major societal challenges (starting with healthy aging), and removing barriers to bringing ideas to the market.

Management and Analysis of Biological and Clinical Data: How Computer Science May Support Biomedical and Clinical Research

NASA Astrophysics Data System (ADS)

Veltri, Pierangelo

The use of computer based solutions for data management in biology and clinical science has contributed to improve life-quality and also to gather research results in shorter time. Indeed, new algorithms and high performance computation have been using in proteomics and genomics studies for curing chronic diseases (e.g., drug designing) as well as supporting clinicians both in diagnosis (e.g., images-based diagnosis) and patient curing (e.g., computer based information analysis on information gathered from patient). In this paper we survey on examples of computer based techniques applied in both biology and clinical contexts. The reported applications are also results of experiences in real case applications at University Medical School of Catanzaro and also part of experiences of the National project Staywell SH 2.0 involving many research centers and companies aiming to study and improve citizen wellness.

Keeping Clinicians in Clinical Research: The Clinical Research/Reproductive Scientist Training Program

PubMed Central

Armstrong, Alicia Y.; DeCherney, Alan; Leppert, Phyllis; Rebar, Robert; Maddox, Yvonne T.

2009-01-01

In recent years the need for translational and clinical research has increased while the number of physicians involved in clinical research has diminished. There is clearly a need for formalized academic training in the quantitative and methodological principles of clinical research in reproductive medicine. The Clinical Research/Reproductive Scientist Training Program (CREST), a program supported by the National Institute of Child Health and Human Development, the Clinical Research Training Program (CRTP) at Duke University, and the American Society for Reproductive Medicine,(ASRM) meets this existing need. In addition, this program is specifically designed for physicians in private or academic clinical practice in reproductive medicine. Innovative programs such as CREST encourage the practicing physician to engage in clinical research while maintaining an active role in clinical practice. Participants in the program receive didactic on-line training from the CRTP, attend intensive weekend seminars at the National Institutes of Health (NIH) and CREST seminars at the annual meeting of ASRM. Successful participants in the program receive a Certificate in Clinical Research from the CRTP. The program’s goal is to provide practicing physicians with the tools and research credentials that will facilitate collaborations with investigators involved in large clinical trials. PMID:19144332

The Ontology of Clinical Research (OCRe): An Informatics Foundation for the Science of Clinical Research

PubMed Central

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

2013-01-01

To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes — the science of clinical research — are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe’s modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study’s scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research. PMID:24239612

Methodological Reflections on the Contribution of Qualitative Research to the Evaluation of Clinical Ethics Support Services.

PubMed

Wäscher, Sebastian; Salloch, Sabine; Ritter, Peter; Vollmann, Jochen; Schildmann, Jan

2017-05-01

This article describes a process of developing, implementing and evaluating a clinical ethics support service intervention with the goal of building up a context-sensitive structure of minimal clinical-ethics in an oncology department without prior clinical ethics structure. Scholars from different disciplines have called for an improvement in the evaluation of clinical ethics support services (CESS) for different reasons over several decades. However, while a lot has been said about the concepts and methodological challenges of evaluating CESS up to the present time, relatively few empirical studies have been carried out. The aim of this article is twofold. On the one hand, it describes a process of development, modifying and evaluating a CESS intervention as part of the ETHICO research project, using the approach of qualitative-formative evaluation. On the other hand, it provides a methodological analysis which specifies the contribution of qualitative empirical methods to the (formative) evaluation of CESS. We conclude with a consideration of the strengths and limitations of qualitative evaluation research with regards to the evaluation and development of context sensitive CESS. We further discuss our own approach in contrast to rather traditional consult or committee models. © 2017 John Wiley & Sons Ltd.

Clinical Research: A Globalized Network

PubMed Central

Richter, Trevor A.

2014-01-01

Clinical research has become increasingly globalized, but the extent of globalization has not been assessed. To describe the globalization of clinical research, we used all (n = 13,208) multinational trials registered at ClinicalTrials.gov to analyzed geographic connections among individual countries. Our findings indicate that 95% (n = 185) of all countries worldwide have participated in multinational clinical research. Growth in the globalization of clinical research peaked in 2009, suggesting that the global infrastructure that supports clinical research might have reached its maximum capacity. Growth in the globalization of clinical research is attributable to increased involvement of non-traditional markets, particularly in South America and Asia. Nevertheless, Europe is the most highly interconnected geographic region (60.64% of global connections), and collectively, Europe, North America, and Asia comprise more than 85% of all global connections. Therefore, while the expansion of clinical trials into non-traditional markets has increased over the last 20 years and connects countries across the globe, traditional markets still dominate multinational clinical research, which appears to have reached a maximum global capacity. PMID:25517976

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

PubMed

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.

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

PubMed

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.

A Framework to Support the Sharing and Reuse of Computable Phenotype Definitions Across Health Care Delivery and Clinical Research Applications.

PubMed

Richesson, Rachel L; Smerek, Michelle M; Blake Cameron, C

2016-01-01

The ability to reproducibly identify clinically equivalent patient populations is critical to the vision of learning health care systems that implement and evaluate evidence-based treatments. The use of common or semantically equivalent phenotype definitions across research and health care use cases will support this aim. Currently, there is no single consolidated repository for computable phenotype definitions, making it difficult to find all definitions that already exist, and also hindering the sharing of definitions between user groups. Drawing from our experience in an academic medical center that supports a number of multisite research projects and quality improvement studies, we articulate a framework that will support the sharing of phenotype definitions across research and health care use cases, and highlight gaps and areas that need attention and collaborative solutions. An infrastructure for re-using computable phenotype definitions and sharing experience across health care delivery and clinical research applications includes: access to a collection of existing phenotype definitions, information to evaluate their appropriateness for particular applications, a knowledge base of implementation guidance, supporting tools that are user-friendly and intuitive, and a willingness to use them. We encourage prospective researchers and health administrators to re-use existing EHR-based condition definitions where appropriate and share their results with others to support a national culture of learning health care. There are a number of federally funded resources to support these activities, and research sponsors should encourage their use.

A Framework to Support the Sharing and Reuse of Computable Phenotype Definitions Across Health Care Delivery and Clinical Research Applications

PubMed Central

Richesson, Rachel L.; Smerek, Michelle M.; Blake Cameron, C.

2016-01-01

Introduction: The ability to reproducibly identify clinically equivalent patient populations is critical to the vision of learning health care systems that implement and evaluate evidence-based treatments. The use of common or semantically equivalent phenotype definitions across research and health care use cases will support this aim. Currently, there is no single consolidated repository for computable phenotype definitions, making it difficult to find all definitions that already exist, and also hindering the sharing of definitions between user groups. Method: Drawing from our experience in an academic medical center that supports a number of multisite research projects and quality improvement studies, we articulate a framework that will support the sharing of phenotype definitions across research and health care use cases, and highlight gaps and areas that need attention and collaborative solutions. Framework: An infrastructure for re-using computable phenotype definitions and sharing experience across health care delivery and clinical research applications includes: access to a collection of existing phenotype definitions, information to evaluate their appropriateness for particular applications, a knowledge base of implementation guidance, supporting tools that are user-friendly and intuitive, and a willingness to use them. Next Steps: We encourage prospective researchers and health administrators to re-use existing EHR-based condition definitions where appropriate and share their results with others to support a national culture of learning health care. There are a number of federally funded resources to support these activities, and research sponsors should encourage their use. PMID:27563686

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

PubMed

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.

Spotlight on GME/GHSE Supported Research

DTIC Science & Technology

2017-12-07

REPORT TYPE 3. DATES COVERED (From- To) 12/07/2017 Poster 4. TITLE AND SUBTITLE Sa. CONTRACT NUMBER Spotlight on GME/GHSE-Supported Research Sb...Clinical Research Division ., 4t€t.>Jc~"-\\. ~[lJI~IT~&[L IT~W~~UIT@&lYIT©~~ ~~@@~[RJ ~[0@1J[LI1@ 1r (Q)~ @~ An example of a "Parent" 59 MDW/ST R&D Project...ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION 59th Clinical Research Division REPORT NUMBER 1100 Willford Hall Loop, Bldg 4430 JBSA

Strategies to successfully recruit and engage clinical nurses as participants in qualitative clinical research.

PubMed

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.

Research-active clinical nurses: against all odds.

PubMed

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.

Supporting new graduate professional development: a clinical learning framework.

PubMed

Fitzgerald, Cate; Moores, Alis; Coleman, Allison; Fleming, Jennifer

2015-02-01

New graduate occupational therapists are required to competently deliver health-care practices within complex care environments. An occupational therapy clinical education programme within a large public sector health service sought to investigate methods to support new graduates in their clinical learning and professional development. Three cycles of an insider action research approach each using the steps of planning, action, critical observation and reflection were undertaken to investigate new graduate learning strategies, develop a learning framework and pilot its utility. Qualitative research methods were used to analyse data gathered during the action research cycles. Action research identified variations in current practices to support new graduate learning and to the development of the Occupational Therapy Clinical Learning Framework (OTCLF). Investigation into the utility of the OTCLF revealed two themes associated with its implementation namely (i) contribution to learning goal development and (ii) compatibility with existing learning supports. The action research cycles aimed to review current practices to support new graduate learning. The learning framework developed encourages reflection to identify learning needs and the review, discussion of, and engagement in, goal setting and learning strategies. Preliminary evidence indicates that the OTCLF has potential as an approach to guide new graduate goal development supported by supervision. Future opportunity to implement a similar learning framework in other allied health professions was identified, enabling a continuation of the cyclical nature of enquiry, integral to this research approach within the workplace. © 2014 Occupational Therapy Australia.

Clinical Research Nursing: Development of a Residency Program
.

PubMed

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.
.

The Clinical Research Landscape in Rhode Island.

PubMed

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].

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

PubMed

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, <30% of the hospitals had a data 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 < 0.01). The number of education programs was significantly correlated with the number of original articles and case reports in English (r = 0.788), and the number of publications in Japanese (r = 0.648). All hospitals recognized the need for a 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.

Evaluating clinical ethics support in mental healthcare: a systematic literature review.

PubMed

Hem, Marit Helene; Pedersen, Reidar; Norvoll, Reidun; Molewijk, Bert

2015-06-01

A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded 'grey zone articles', in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients' and caregivers' views on ethical challenges, is presented. © The Author(s) 2014.

Grand Challenges in Clinical Decision Support v10

PubMed Central

Sittig, Dean F.; Wright, Adam; Osheroff, Jerome A.; Middleton, Blackford; Teich, Jonathan M.; Ash, Joan S.; Campbell, Emily; Bates, David W.

2008-01-01

There is a pressing need for high-quality, effective means of designing, developing, presenting, implementing, evaluating, and maintaining all types of clinical decision support capabilities for clinicians, patients and consumers. Using an iterative, consensus-building process we identified a rank-ordered list of the top 10 grand challenges in clinical decision support. This list was created to educate and inspire researchers, developers, funders, and policy-makers. The list of challenges in order of importance that they be solved if patients and organizations are to begin realizing the fullest benefits possible of these systems consists of: Improve the human-computer interface; Disseminate best practices in CDS design, development, and implementation; Summarize patient-level information; Prioritize and filter recommendations to the user; Create an architecture for sharing executable CDS modules and services; Combine recommendations for patients with co-morbidities; Prioritize CDS content development and implementation; Create internet-accessible clinical decision support repositories; Use freetext information to drive clinical decision support; Mine large clinical databases to create new CDS. Identification of solutions to these challenges is critical if clinical decision support is to achieve its potential and improve the quality, safety and efficiency of healthcare. PMID:18029232

Database on veterinary clinical research in homeopathy.

PubMed

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.

American Society of Clinical Oncology policy statement: oversight of clinical research.

PubMed

2003-06-15

Well-publicized lapses in the review or implementation of clinical research studies have raised public questions about the integrity of the clinical research process. Public trust in the integrity of research is critical not only for funding and participation in clinical trials but also for confidence in the treatments that result from the trials. The questions raised by these unfortunate cases pose an important opportunity to reassess the clinical trials oversight system to ensure the integrity of clinical research and the safety of those who enroll in clinical trials. Since its inception, the American Society of Clinical Oncology (ASCO) has worked for the advancement of cancer treatments through clinical research and to help patients gain prompt access to scientifically excellent and ethically unimpeachable clinical trials. As an extension of its mission, ASCO is affirming with this policy statement the critical importance of a robust review and oversight system to ensure that clinical trials participants give fully informed consent and that their safety is a top priority. Ensuring the integrity of research cannot be stressed enough because of its seminal connection to the advancement of clinical cancer treatment. The overall goal of this policy is to enhance public trust in the cancer clinical trials process. To achieve this, the following elements are essential: 1. Ensure safety precautions for clinical trial participants and their fully informed consent. 2. Ensure the validity and integrity of scientific research. 3. Enhance the educational training of clinical scientists and research staff to ensure the highest standards of research conduct. 4. Promote accountability and responsibility among all those involved in clinical research (not just those serving on institutional review boards [IRBs], but also institutional officials, researchers, sponsors, and participants) and ensure support for an effective oversight process. 5. Enhance the professional and public

Establishing a successful clinical research program.

PubMed

Scoglio, Daniele; Fichera, Alessandro

2014-06-01

Clinical research (CR) is a natural corollary to clinical surgery. It gives an investigator the opportunity to critically review their results and develop new strategies. This article covers the critical factors and the important components of a successful CR program. The first and most important step is to build a dedicated research team to overcome time constraints and enable a surgical practice to make CR a priority. With the research team in place, the next step is to create a program on the basis of an original idea and new clinical hypotheses. This often comes from personal experience supported by a review of the available evidence. Randomized controlled (clinical) trials are the most stringent way of determining whether a cause-effect relationship exists between the intervention and the outcome. In the proper setting, translational research may offer additional avenues allowing clinical application of basic science discoveries.

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

PubMed

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

2014-01-01

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

From Free to Free Market: Cost Recovery in Federally Funded Clinical Research

PubMed Central

McCammon, Margaret G.; Fogg, Thomas T.; Jacobsen, Lynda; Roache, John; Sampson, Royce; Bower, Cynthia L.

2012-01-01

In a climate of increased expectation for the translation of research, academic clinical research units are looking at new ways to streamline their operation and maintain effective translational support services. Clinical research, although undeniably expensive, is an essential step in the translation of any medical breakthrough, and as a result, many academic clinical research units are actively looking to expand their clinical services despite financial pressures. We examine some of the hybrid academic-business models in 19 clinical research centers within the Clinical and Translational Science Award consortium that are emerging to address the issue of cost recovery of clinical research that is supported by the United States federal government. We identify initiatives that have succeeded or failed, essential supporting and regulatory components, and lessons learned from experience to design an optimal cost recovery model and a timeline for its implementation. PMID:22764204

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

PubMed

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.

What can Natural Language Processing do for Clinical Decision Support?

PubMed Central

Demner-Fushman, Dina; Chapman, Wendy W.; McDonald, Clement J.

2009-01-01

Computerized Clinical Decision Support (CDS) aims to aid decision making of health care providers and the public by providing easily accessible health-related information at the point and time it is needed. Natural Language Processing (NLP) is instrumental in using free-text information to drive CDS, representing clinical knowledge and CDS interventions in standardized formats, and leveraging clinical narrative. The early innovative NLP research of clinical narrative was followed by a period of stable research conducted at the major clinical centers and a shift of mainstream interest to biomedical NLP. This review primarily focuses on the recently renewed interest in development of fundamental NLP methods and advances in the NLP systems for CDS. The current solutions to challenges posed by distinct sublanguages, intended user groups, and support goals are discussed. PMID:19683066

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

PubMed

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

Team building: electronic management-clinical translational research (eM-CTR) systems.

PubMed

Cecchetti, Alfred A; Parmanto, Bambang; Vecchio, Marcella L; Ahmad, Sjarif; Buch, Shama; Zgheib, Nathalie K; Groark, Stephen J; Vemuganti, Anupama; Romkes, Marjorie; Sciurba, Frank; Donahoe, Michael P; Branch, Robert A

2009-12-01

Classical drug exposure: response studies in clinical pharmacology represent the quintessential prototype for Bench to Bedside-Clinical Translational Research. A fundamental premise of this approach is for a multidisciplinary team of researchers to design and execute complex, in-depth mechanistic studies conducted in relatively small groups of subjects. The infrastructure support for this genre of clinical research is not well-handled by scaling down of infrastructure used for large Phase III clinical trials. We describe a novel, integrated strategy, whose focus is to support and manage a study using an Information Hub, Communication Hub, and Data Hub design. This design is illustrated by an application to a series of varied projects sponsored by Special Clinical Centers of Research in chronic obstructive pulmonary disease at the University of Pittsburgh. In contrast to classical informatics support, it is readily scalable to large studies. Our experience suggests the culture consequences of research group self-empowerment is not only economically efficient but transformative to the research process.

Postdoctoral Clinical-Research Training in Psychiatry

PubMed Central

Reynolds, Charles F.; Martin, Christopher; Brent, David; Ryan, Neal; Dahl, Ronald E.; Pilkonis, Paul; Marcus, Marsha D.; Kupfer, David J.

2009-01-01

The authors describe a model for teaching grant writing and other research survival skills to postdoctoral clinical-research fellows in psychiatry and for improving research mentoring. Over the past 4 years, the authors have developed a course on writing grant applications for postdoctoral clinical-research fellows, using peer-review processes modeled after a National Institutes of Health study section. At the same time, the authors have clarified expectations of mentors in ways designed to help fellows prepare “K” (Research Career Development) applications and to receive mentored practice in skills being taught in the course. Sixteen of 30 fellows have succeeded in receiving their first extramural support by the end of their two-year fellowship tenure or during the succeeding year. The authors conclude that by teaching grant-writing skills in a supportive peer environment, providing peer review of proposals, and sharpening expectations of mentors, it may be possible to reduce the time between the end of fellowship and the receipt of the first extramural grant. PMID:19617924

Measurement-based care for refractory depression: a clinical decision support model for clinical research and practice.

PubMed

Trivedi, Madhukar H; Daly, Ella J

2007-05-01

Despite years of antidepressant drug development and patient and provider education, suboptimal medication dosing and duration of exposure resulting in incomplete remission of symptoms remains the norm in the treatment of depression. Additionally, since no one treatment is effective for all patients, optimal implementation focusing on the measurement of symptoms, side effects, and function is essential to determine effective sequential treatment approaches. There is a need for a paradigm shift in how clinical decision making is incorporated into clinical practice and for a move away from the trial-and-error approach that currently determines the "next best" treatment. This paper describes how our experience with the Texas Medication Algorithm Project (TMAP) and the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial has confirmed the need for easy-to-use clinical support systems to ensure fidelity to guidelines. To further enhance guideline fidelity, we have developed an electronic decision support system that provides critical feedback and guidance at the point of patient care. We believe that a measurement-based care (MBC) approach is essential to any decision support system, allowing physicians to individualize and adapt decisions about patient care based on symptom progress, tolerability of medication, and dose optimization. We also believe that successful integration of sequential algorithms with MBC into real-world clinics will facilitate change that will endure and improve patient outcomes. Although we use major depression to illustrate our approach, the issues addressed are applicable to other chronic psychiatric conditions including comorbid depression and substance use disorder as well as other medical illnesses.

Measurement-Based Care for Refractory Depression: A Clinical Decision Support Model for Clinical Research and Practice

PubMed Central

Trivedi, Madhukar H.; Daly, Ella J.

2009-01-01

Despite years of antidepressant drug development and patient and provider education, suboptimal medication dosing and duration of exposure resulting in incomplete remission of symptoms remains the norm in the treatment of depression. Additionally, since no one treatment is effective for all patients, optimal implementation focusing on the measurement of symptoms, side effects, and function is essential to determine effective sequential treatment approaches. There is a need for a paradigm shift in how clinical decision making is incorporated into clinical practice and for a move away from the trial-and-error approach that currently determines the “next best” treatment. This paper describes how our experience with the Texas Medication Algorithm Project (TMAP) and the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial has confirmed the need for easy-to-use clinical support systems to ensure fidelity to guidelines. To further enhance guideline fidelity, we have developed an electronic decision support system that provides critical feedback and guidance at the point of patient care. We believe that a measurement-based care (MBC) approach is essential to any decision support system, allowing physicians to individualize and adapt decisions about patient care based on symptom progress, tolerability of medication, and dose optimization. We also believe that successful integration of sequential algorithms with MBC into real-world clinics will facilitate change that will endure and improve patient outcomes. Although we use major depression to illustrate our approach, the issues addressed are applicable to other chronic psychiatric conditions including comorbid depression and substance use disorder as well as other medical illnesses. PMID:17320312

Nurses' Clinical Decision Making on Adopting a Wound Clinical Decision Support System.

PubMed

Khong, Peck Chui Betty; Hoi, Shu Yin; Holroyd, Eleanor; Wang, Wenru

2015-07-01

Healthcare information technology systems are considered the ideal tool to inculcate evidence-based nursing practices. The wound clinical decision support system was built locally to support nurses to manage pressure ulcer wounds in their daily practice. However, its adoption rate is not optimal. The study's objective was to discover the concepts that informed the RNs' decisions to adopt the wound clinical decision support system as an evidence-based technology in their nursing practice. This was an exploratory, descriptive, and qualitative design using face-to-face interviews, individual interviews, and active participatory observation. A purposive, theoretical sample of 14 RNs was recruited from one of the largest public tertiary hospitals in Singapore after obtaining ethics approval. After consenting, the nurses were interviewed and observed separately. Recruitment stopped when data saturation was reached. All transcribed interview data underwent a concurrent thematic analysis, whereas observational data were content analyzed independently and subsequently triangulated with the interview data. Eight emerging themes were identified, namely, use of the wound clinical decision support system, beliefs in the wound clinical decision support system, influences of the workplace culture, extent of the benefits, professional control over nursing practices, use of knowledge, gut feelings, and emotions (fear, doubt, and frustration). These themes represented the nurses' mental outlook as they made decisions on adopting the wound clinical decision support system in light of the complexities of their roles and workloads. This research has provided insight on the nurses' thoughts regarding their decision to interact with the computer environment in a Singapore context. It captured the nurses' complex thoughts when deciding whether to adopt or reject information technology as they practice in a clinical setting.

Clinical Research Informatics Contributions from 2015.

PubMed

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

Computerized Clinical Decision Support: Contributions from 2015

PubMed Central

Bouaud, J.

2016-01-01

Summary Objective To summarize recent research and select the best papers published in 2015 in the field of computerized clinical decision support for the Decision Support section of the IMIA yearbook. Method A literature review was performed by searching two bibliographic databases for papers related to clinical decision support systems (CDSSs) and computerized provider order entry (CPOE) systems. The aim was to identify a list of candidate best papers from the retrieved papers that were then peer-reviewed by external reviewers. A consensus meeting between the two section editors and the IMIA editorial team was finally conducted to conclude in the best paper selection. Results Among the 974 retrieved papers, the entire review process resulted in the selection of four best papers. One paper reports on a CDSS routinely applied in pediatrics for more than 10 years, relying on adaptations of the Arden Syntax. Another paper assessed the acceptability and feasibility of an important CPOE evaluation tool in hospitals outside the US where it was developed. The third paper is a systematic, qualitative review, concerning usability flaws of medication-related alerting functions, providing an important evidence-based, methodological contribution in the domain of CDSS design and development in general. Lastly, the fourth paper describes a study quantifying the effect of a complex, continuous-care, guideline-based CDSS on the correctness and completeness of clinicians’ decisions. Conclusions While there are notable examples of routinely used decision support systems, this 2015 review on CDSSs and CPOE systems still shows that, despite methodological contributions, theoretical frameworks, and prototype developments, these technologies are not yet widely spread (at least with their full functionalities) in routine clinical practice. Further research, testing, evaluation, and training are still needed for these tools to be adopted in clinical practice and, ultimately, illustrate

Key factors of clinical research network capacity building.

PubMed

Li, Guowei; Wu, Qianyu; Jin, Yanling; Vanniyasingam, Thuva; Thabane, Lehana

2018-01-01

In general, clinical research network capacity building refers to programs aimed at enhancing networks of researchers to conduct clinical research. Although in the literature there is a large body of research on how to develop and build capacity in clinical research networks, the conceptualizations and implementations remain controversial and challenging. Moreover, the experiences learnt from the past accomplishments and failures can assist in the future capacity building efforts to be more practical, effective and efficient. In this paper, we aim to provide an overview of capacity building in clinical research network by (1) identifying the key barriers to clinical research network capacity building, (2) providing insights into how to overcome those obstacles, and (3) sharing our experiences in collaborating with national and international partners to build capacity in clinical research networks. In conclusion, we have provided some insight into how to address the key factors of clinical research network capacity building and shared some empirical experiences. A successful capacity building practice requires a joint endeavor to procure sufficient resources and support from the relevant stakeholders, to ensure its efficiency, cost-effectiveness, and sustainability.

Report of the Task Force on Clinical Research in Dentistry.

ERIC Educational Resources Information Center

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…

Innovating to enhance clinical data management using non-commercial and open source solutions across a multi-center network supporting inpatient pediatric care and research in Kenya

PubMed Central

Tuti, Timothy; Bitok, Michael; Paton, Chris; Makone, Boniface; Malla, Lucas; Muinga, Naomi; Gathara, David; English, Mike

2016-01-01

Objective To share approaches and innovations adopted to deliver a relatively inexpensive clinical data management (CDM) framework within a low-income setting that aims to deliver quality pediatric data useful for supporting research, strengthening the information culture and informing improvement efforts in local clinical practice. Materials and methods The authors implemented a CDM framework to support a Clinical Information Network (CIN) using Research Electronic Data Capture (REDCap), a noncommercial software solution designed for rapid development and deployment of electronic data capture tools. It was used for collection of standardized data from case records of multiple hospitals’ pediatric wards. R, an open-source statistical language, was used for data quality enhancement, analysis, and report generation for the hospitals. Results In the first year of CIN, the authors have developed innovative solutions to support the implementation of a secure, rapid pediatric data collection system spanning 14 hospital sites with stringent data quality checks. Data have been collated on over 37 000 admission episodes, with considerable improvement in clinical documentation of admissions observed. Using meta-programming techniques in R, coupled with branching logic, randomization, data lookup, and Application Programming Interface (API) features offered by REDCap, CDM tasks were configured and automated to ensure quality data was delivered for clinical improvement and research use. Conclusion A low-cost clinically focused but geographically dispersed quality CDM (Clinical Data Management) in a long-term, multi-site, and real world context can be achieved and sustained and challenges can be overcome through thoughtful design and implementation of open-source tools for handling data and supporting research. PMID:26063746

Decline of clinical research in academic medical centers.

PubMed

Meador, Kimford J

2015-09-29

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

Decline of clinical research in academic medical centers

PubMed Central

2015-01-01

Marked changes in US medical school funding began in the 1960s with progressively increasing revenues from clinical services. The growth of clinical revenues slowed in the mid-1990s, creating a funding crisis for US academic health care centers, who responded by having their faculty increase their clinical duties at the expense of research activities. Surveys document the resultant stresses on the academic clinician researcher. The NIH provides greater funding for basic and translational research than for clinical research, and the new Patient-Centered Outcomes Research Institute is inadequately funded to address the scope of needed clinical research. An increasing portion of clinical research is funded by industry, which leaves many important clinical issues unaddressed. There is an inadequate supply of skilled clinical researchers and a lack of external support for clinical research. The impact on the academic environment in university medical centers is especially severe on young faculty, who have a shrinking potential to achieve successful academic careers. National health care research funding policies should encourage the right balance of life-science investigations. Medical universities need to improve and highlight education on clinical research for students, residents, fellows, and young faculty. Medical universities also need to provide appropriate incentives for clinical research. Without training to ensure an adequate supply of skilled clinical researchers and a method to adequately fund clinical research, discoveries from basic and translational research cannot be clinically tested and affect patient care. Thus, many clinical problems will continue to be evaluated and treated with inadequate or even absent evidence-based knowledge. PMID:26156509

Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: methods of a decision-maker-researcher partnership systematic review.

PubMed

Haynes, R Brian; Wilczynski, Nancy L

2010-02-05

Computerized clinical decision support systems are information technology-based systems designed to improve clinical decision-making. As with any healthcare intervention with claims to improve process of care or patient outcomes, decision support systems should be rigorously evaluated before widespread dissemination into clinical practice. Engaging healthcare providers and managers in the review process may facilitate knowledge translation and uptake. The objective of this research was to form a partnership of healthcare providers, managers, and researchers to review randomized controlled trials assessing the effects of computerized decision support for six clinical application areas: primary preventive care, therapeutic drug monitoring and dosing, drug prescribing, chronic disease management, diagnostic test ordering and interpretation, and acute care management; and to identify study characteristics that predict benefit. The review was undertaken by the Health Information Research Unit, McMaster University, in partnership with Hamilton Health Sciences, the Hamilton, Niagara, Haldimand, and Brant Local Health Integration Network, and pertinent healthcare service teams. Following agreement on information needs and interests with decision-makers, our earlier systematic review was updated by searching Medline, EMBASE, EBM Review databases, and Inspec, and reviewing reference lists through 6 January 2010. Data extraction items were expanded according to input from decision-makers. Authors of primary studies were contacted to confirm data and to provide additional information. Eligible trials were organized according to clinical area of application. We included randomized controlled trials that evaluated the effect on practitioner performance or patient outcomes of patient care provided with a computerized clinical decision support system compared with patient care without such a system. Data will be summarized using descriptive summary measures, including proportions

A SOA-Based Platform to Support Clinical Data Sharing.

PubMed

Gazzarata, R; Giannini, B; Giacomini, M

2017-01-01

The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the "Interoperable" Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes) vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the "Interoperable" Tier, the current solution actually covers the "Connected" Tier, due to local hospital policy restrictions.

Clinical research in the United States at a crossroads: proposal for a novel public-private partnership to establish a national clinical research enterprise.

PubMed

Crowley, William F; Sherwood, Louis; Salber, Patricia; Scheinberg, David; Slavkin, Hal; Tilson, Hugh; Reece, E Albert; Catanese, Veronica; Johnson, Stephen B; Dobs, Adrian; Genel, Myron; Korn, Allan; Reame, Nancy; Bonow, Robert; Grebb, Jack; Rimoin, David

2004-03-03

The clinical research infrastructure of the United States is currently at a critical crossroads. To leverage the enormous biomedical research gains made in the past century efficiently, a drastic need exists to reengineer this system into a coordinated, safe, and more efficient and effective enterprise. To accomplish this task, clinical research must be transformed from its current state as a cottage industry to an enterprise-wide health care pipeline whose function is to bring the novel research from both government and private entities to the US public. We propose the establishment of a unique public-private partnership termed the National Clinical Research Enterprise (NCRE). Its agenda should consist of informed public participation, supportive information technologies, a skilled workforce, and adequate funding in clinical research. Devoting only 0.25% of the budgets from all health care stakeholders to support the NCRE would permit adequate funding to build the infrastructure required to address these problems in an enterprise fashion. All participants in the US health care delivery system must come together to focus on system-wide improvements that will benefit the public.

Innovating to enhance clinical data management using non-commercial and open source solutions across a multi-center network supporting inpatient pediatric care and research in Kenya.

PubMed

Tuti, Timothy; Bitok, Michael; Paton, Chris; Makone, Boniface; Malla, Lucas; Muinga, Naomi; Gathara, David; English, Mike

2016-01-01

To share approaches and innovations adopted to deliver a relatively inexpensive clinical data management (CDM) framework within a low-income setting that aims to deliver quality pediatric data useful for supporting research, strengthening the information culture and informing improvement efforts in local clinical practice. The authors implemented a CDM framework to support a Clinical Information Network (CIN) using Research Electronic Data Capture (REDCap), a noncommercial software solution designed for rapid development and deployment of electronic data capture tools. It was used for collection of standardized data from case records of multiple hospitals' pediatric wards. R, an open-source statistical language, was used for data quality enhancement, analysis, and report generation for the hospitals. In the first year of CIN, the authors have developed innovative solutions to support the implementation of a secure, rapid pediatric data collection system spanning 14 hospital sites with stringent data quality checks. Data have been collated on over 37 000 admission episodes, with considerable improvement in clinical documentation of admissions observed. Using meta-programming techniques in R, coupled with branching logic, randomization, data lookup, and Application Programming Interface (API) features offered by REDCap, CDM tasks were configured and automated to ensure quality data was delivered for clinical improvement and research use. A low-cost clinically focused but geographically dispersed quality CDM (Clinical Data Management) in a long-term, multi-site, and real world context can be achieved and sustained and challenges can be overcome through thoughtful design and implementation of open-source tools for handling data and supporting research. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Research evaluation support services in biomedical libraries

PubMed Central

Gutzman, Karen Elizabeth; Bales, Michael E.; Belter, Christopher W.; Chambers, Thane; Chan, Liza; Holmes, Kristi L.; Lu, Ya-Ling; Palmer, Lisa A.; Reznik-Zellen, Rebecca C.; Sarli, Cathy C.; Suiter, Amy M.; Wheeler, Terrie R.

2018-01-01

Objective The paper provides a review of current practices related to evaluation support services reported by seven biomedical and research libraries. Methods A group of seven libraries from the United States and Canada described their experiences with establishing evaluation support services at their libraries. A questionnaire was distributed among the libraries to elicit information as to program development, service and staffing models, campus partnerships, training, products such as tools and reports, and resources used for evaluation support services. The libraries also reported interesting projects, lessons learned, and future plans. Results The seven libraries profiled in this paper report a variety of service models in providing evaluation support services to meet the needs of campus stakeholders. The service models range from research center cores, partnerships with research groups, and library programs with staff dedicated to evaluation support services. A variety of products and services were described such as an automated tool to develop rank-based metrics, consultation on appropriate metrics to use for evaluation, customized publication and citation reports, resource guides, classes and training, and others. Implementing these services has allowed the libraries to expand their roles on campus and to contribute more directly to the research missions of their institutions. Conclusions Libraries can leverage a variety of evaluation support services as an opportunity to successfully meet an array of challenges confronting the biomedical research community, including robust efforts to report and demonstrate tangible and meaningful outcomes of biomedical research and clinical care. These services represent a transformative direction that can be emulated by other biomedical and research libraries. PMID:29339930

Research evaluation support services in biomedical libraries.

PubMed

Gutzman, Karen Elizabeth; Bales, Michael E; Belter, Christopher W; Chambers, Thane; Chan, Liza; Holmes, Kristi L; Lu, Ya-Ling; Palmer, Lisa A; Reznik-Zellen, Rebecca C; Sarli, Cathy C; Suiter, Amy M; Wheeler, Terrie R

2018-01-01

The paper provides a review of current practices related to evaluation support services reported by seven biomedical and research libraries. A group of seven libraries from the United States and Canada described their experiences with establishing evaluation support services at their libraries. A questionnaire was distributed among the libraries to elicit information as to program development, service and staffing models, campus partnerships, training, products such as tools and reports, and resources used for evaluation support services. The libraries also reported interesting projects, lessons learned, and future plans. The seven libraries profiled in this paper report a variety of service models in providing evaluation support services to meet the needs of campus stakeholders. The service models range from research center cores, partnerships with research groups, and library programs with staff dedicated to evaluation support services. A variety of products and services were described such as an automated tool to develop rank-based metrics, consultation on appropriate metrics to use for evaluation, customized publication and citation reports, resource guides, classes and training, and others. Implementing these services has allowed the libraries to expand their roles on campus and to contribute more directly to the research missions of their institutions. Libraries can leverage a variety of evaluation support services as an opportunity to successfully meet an array of challenges confronting the biomedical research community, including robust efforts to report and demonstrate tangible and meaningful outcomes of biomedical research and clinical care. These services represent a transformative direction that can be emulated by other biomedical and research libraries.

Semantic processing of EHR data for clinical research.

PubMed

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.

Developing translational research infrastructure and capabilities associated with cancer clinical trials.

PubMed

Hall, Jacqueline A; Brown, Robert

2013-09-27

The integration of molecular information in clinical decision making is becoming a reality. These changes are shaping the way clinical research is conducted, and as reality sets in, the challenges in conducting, managing and organising multi-disciplinary research become apparent. Clinical trials provide a platform to conduct translational research (TR) within the context of high quality clinical data accrual. Integrating TR objectives in trials allows the execution of pivotal studies that provide clinical evidence for biomarker-driven treatment strategies, targeting early drug development trials to a homogeneous and well defined patient population, supports the development of companion diagnostics and provides an opportunity for deepening our understanding of cancer biology and mechanisms of drug action. To achieve these goals within a clinical trial, developing translational research infrastructure and capabilities (TRIC) plays a critical catalytic role for translating preclinical data into successful clinical research and development. TRIC represents a technical platform, dedicated resources and access to expertise promoting high quality standards, logistical and operational support and unified streamlined procedures under an appropriate governance framework. TRIC promotes integration of multiple disciplines including biobanking, laboratory analysis, molecular data, informatics, statistical analysis and dissemination of results which are all required for successful TR projects and scientific progress. Such a supporting infrastructure is absolutely essential in order to promote high quality robust research, avoid duplication and coordinate resources. Lack of such infrastructure, we would argue, is one reason for the limited effect of TR in clinical practice beyond clinical trials.

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

PubMed

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.

A SOA-Based Platform to Support Clinical Data Sharing

PubMed

Gazzarata, R; Giannini, B; Giacomini, M

2017-01-01

The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the “Interoperable” Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes) vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the “Interoperable” Tier, the current solution actually covers the “Connected” Tier, due to local hospital policy restrictions. © 2017 R. Gazzarata et al.

A SOA-Based Platform to Support Clinical Data Sharing

PubMed Central

Gazzarata, R.; Giannini, B.

2017-01-01

The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the “Interoperable” Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes) vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the “Interoperable” Tier, the current solution actually covers the “Connected” Tier, due to local hospital policy restrictions. PMID:29065576

Current State of Information Technologies for the Clinical Research Enterprise across Academic Medical Centers

PubMed Central

Murphy, Shawn N.; Dubey, Anil; Embi, Peter J.; Harris, Paul A.; Richter, Brent G.; Turisco, Fran; Weber, Griffin M.; Tcheng, James E.; Keogh, Diane

2012-01-01

Abstract Information technology (IT) to support clinical research has steadily grown over the past 10 years. Many new applications at the enterprise level are available to assist with the numerous tasks necessary in performing clinical research. However, it is not clear how rapidly this technology is being adopted or whether it is making an impact upon how clinical research is being performed. The Clinical Research Forum’s IT Roundtable performed a survey of 17 representative academic medical centers (AMCs) to understand the adoption rate and implementation strategies within this field. The results were compared with similar surveys from 4 and 6 years ago. We found the adoption rate for four prominent areas of IT‐supported clinical research had increased remarkably, specifically regulatory compliance, electronic data capture for clinical trials, data repositories for secondary use of clinical data, and infrastructure for supporting collaboration. Adoption of other areas of clinical research IT was more irregular with wider differences between AMCs. These differences appeared to be partially due to a set of openly available applications that have emerged to occupy an important place in the landscape of clinical research enterprise‐level support at AMC’s. Clin Trans Sci 2012; Volume #: 1–4 PMID:22686207

Pediatric Oncology Branch - Support Services | Center for Cancer Research

Cancer.gov

Support Services As part of the comprehensive care provided at the NCI Pediatric Oncology Branch, we provide a wide range of services to address the social, psychological, emotional, and practical facets of pediatric cancer and to support patients and families while they are enrolled in clinical research protocols.

Implementation of workflow engine technology to deliver basic clinical decision support functionality

PubMed Central

2011-01-01

Background Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic. Results We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture. Conclusions We describe an implementation of

Implementation of workflow engine technology to deliver basic clinical decision support functionality.

PubMed

Huser, Vojtech; Rasmussen, Luke V; Oberg, Ryan; Starren, Justin B

2011-04-10

Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic. We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture. We describe an implementation of a free workflow technology

Department of Defense prostate cancer clinical trials consortium: a new instrument for prostate cancer clinical research.

PubMed

Morris, Michael J; Basch, Ethan M; Wilding, George; Hussain, Maha; Carducci, Michael A; Higano, Celestia; Kantoff, Philip; Oh, William K; Small, Eric J; George, Daniel; Mathew, Paul; Beer, Tomasz M; Slovin, Susan F; Ryan, Charles; Logothetis, Christopher; Scher, Howard I

2009-01-01

In 2005, the US Department of Defense, through the US Army Medical Research and Materiel Command, Office of the Congressionally Directed Medical Research Programs, created a funding mechanism to form a clinical trials consortium to conduct phase I and II studies in prostate cancer. This is the first report of the Prostate Cancer Clinical Trials Consortium (PCCTC). The Department of Defense award supports a consortium of 10 prostate cancer research centers. Memorial Sloan-Kettering Cancer Center was awarded the Coordinating Center grant for the consortium and charged with creating an infrastructure to conduct early-phase multicenter clinical trials. Each participating center was required to introduce >or=1 clinical trial per year and maintain accrual of a minimum of 35 patients per year. The PCCTC was launched in 2006 and now encompasses 10 leading prostate cancer research centers. Fifty-one trials have been opened, and 1386 patients have been accrued at member sites. Members share an online clinical trial management system for protocol tracking, electronic data capture, and data storage. A legal framework has been instituted, and standard operating procedures, an administrative structure, editorial support, centralized budgeting, and mechanisms for scientific review are established. The PCCTC fulfills a congressional directive to create a clinical trials instrument dedicated to early-phase prostate cancer studies. The member institutions have built an administrative, informatics, legal, financial, statistical, and scientific infrastructure to support this endeavor. Clinical trials are open and accruing in excess of federally mandated goals.

Cannabis in Pain Treatment: Clinical and Research Considerations.

PubMed

Savage, Seddon R; Romero-Sandoval, Alfonso; Schatman, Michael; Wallace, Mark; Fanciullo, Gilbert; McCarberg, Bill; Ware, Mark

2016-06-01

Cannabinoids show promise as therapeutic agents, particularly as analgesics, but their development and clinical use has been complicated by recognition of their botanical source, cannabis, as a substance of misuse. Although research into endogenous cannabinoid systems and potential cannabinoid pharmaceuticals is slowly increasing, there has been intense societal interest in making herbal (plant) cannabis available for medicinal use; 23 U.S. States and all Canadian provinces currently permit use in some clinical contexts. Whether or not individual professionals support the clinical use of herbal cannabis, all clinicians will encounter patients who elect to use it and therefore need to be prepared to advise them on cannabis-related clinical issues despite limited evidence to guide care. Expanded research on cannabis is needed to better determine the individual and public health effects of increasing use of herbal cannabis and to advance understanding of the pharmaceutical potential of cannabinoids as medications. This article reviews clinical, research, and policy issues related to herbal cannabis to support clinicians in thoughtfully advising and caring for patients who use cannabis, and it examines obstacles and opportunities to expand research on the health effects of herbal cannabis and cannabinoids. Herbal cannabis is increasingly available for clinical use in the United States despite continuing controversies over its efficacy and safety. This article explores important considerations in the use of plant Cannabis to better prepare clinicians to care for patients who use it, and identifies needed directions for research. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

Clinical trials: bringing research to the bedside.

PubMed

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.

A European perspective--the European clinical research infrastructures network.

PubMed

Demotes-Mainard, J; Kubiak, C

2011-11-01

Evaluating research outcomes requires multinational cooperation in clinical research for optimization of treatment strategies and comparative effectiveness research, leading to evidence-based practice and healthcare cost containment. The European Clinical Research Infrastructures Network (ECRIN) is a distributed ESFRI (European Strategy Forum on Research Infrastructures) roadmap pan-European infrastructure designed to support multinational clinical research, making Europe a single area for clinical studies, taking advantage of its population size to access patients, and unlocking latent scientific potential. Servicing multinational trials started during its preparatory phase, and ECRIN will now apply for an ERIC (European Research Infrastructures Consortium) status by 2011. By creating a single area for clinical research in Europe, this achievement will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of the research and education capacity, tackling the major societal challenges starting with the area of healthy ageing, and removing barriers to bring ideas to the market.

Humanistic psychotherapy research 1990-2015: from methodological innovation to evidence-supported treatment outcomes and beyond.

PubMed

Angus, Lynne; Watson, Jeanne Cherry; Elliott, Robert; Schneider, Kirk; Timulak, Ladislav

2015-01-01

Over the past 25 years, humanistic psychotherapy (HP) researchers have actively contributed to the development and implementation of innovative practice-informed research measures and coding systems. Qualitative and quantitative research findings, including meta-analyses, support the identification of HP approaches as evidence-based treatments for a variety of psychological conditions. Implications for future psychotherapy research, training, and practice are discussed in terms of addressing the persistent disjunction between significant HP research productivity and relatively low support for HP approaches in university-based clinical training programs, funding agencies, and government-supported clinical guidelines. Finally, specific recommendations are provided to further enhance and expand the impact of HP research for clinical training programs and the development of treatment guidelines.

Data standards for clinical research data collection forms: current status and challenges.

PubMed

Richesson, Rachel L; Nadkarni, Prakash

2011-05-01

Case report forms (CRFs) are used for structured-data collection in clinical research studies. Existing CRF-related standards encompass structural features of forms and data items, content standards, and specifications for using terminologies. This paper reviews existing standards and discusses their current limitations. Because clinical research is highly protocol-specific, forms-development processes are more easily standardized than is CRF content. Tools that support retrieval and reuse of existing items will enable standards adoption in clinical research applications. Such tools will depend upon formal relationships between items and terminological standards. Future standards adoption will depend upon standardized approaches for bridging generic structural standards and domain-specific content standards. Clinical research informatics can help define tools requirements in terms of workflow support for research activities, reconcile the perspectives of varied clinical research stakeholders, and coordinate standards efforts toward interoperability across healthcare and research data collection.

Using systems thinking to support clinical system transformation.

PubMed

Best, Allan; Berland, Alex; Herbert, Carol; Bitz, Jennifer; van Dijk, Marlies W; Krause, Christina; Cochrane, Douglas; Noel, Kevin; Marsden, Julian; McKeown, Shari; Millar, John

2016-05-16

Purpose - The British Columbia Ministry of Health's Clinical Care Management initiative was used as a case study to better understand large-scale change (LSC) within BC's health system. Using a complex system framework, the purpose of this paper is to examine mechanisms that enable and constrain the implementation of clinical guidelines across various clinical settings. Design/methodology/approach - Researchers applied a general model of complex adaptive systems plus two specific conceptual frameworks (realist evaluation and system dynamics mapping) to define and study enablers and constraints. Focus group sessions and interviews with clinicians, executives, managers and board members were validated through an online survey. Findings - The functional themes for managing large-scale clinical change included: creating a context to prepare clinicians for health system transformation initiatives; promoting shared clinical leadership; strengthening knowledge management, strategic communications and opportunities for networking; and clearing pathways through the complexity of a multilevel, dynamic system. Research limitations/implications - The action research methodology was designed to guide continuing improvement of implementation. A sample of initiatives was selected; it was not intended to compare and contrast facilitators and barriers across all initiatives and regions. Similarly, evaluating the results or process of guideline implementation was outside the scope; the methods were designed to enable conversations at multiple levels - policy, management and practice - about how to improve implementation. The study is best seen as a case study of LSC, offering a possible model for replication by others and a tool to shape further dialogue. Practical implications - Recommended action-oriented strategies included engaging local champions; supporting local adaptation for implementation of clinical guidelines; strengthening local teams to guide implementation; reducing

Developing a clinical trial unit to advance research in an academic institution.

PubMed

Croghan, Ivana T; Viker, Steven D; Limper, Andrew H; Evans, Tamara K; Cornell, Alissa R; Ebbert, Jon O; Gertz, Morie A

2015-11-01

Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trial unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine clinical trial unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a central unit to provide research support in clinical trials and presents the advantages, disadvantages, and required building blocks for such a unit. Copyright © 2015 Mayo Clinic. Published by Elsevier Inc. All rights reserved.

Support for Offering Sexual Health Services through School-Based Health Clinics

ERIC Educational Resources Information Center

Moore, Michele Johnson; Barr, Elissa; Wilson, Kristina; Griner, Stacey

2016-01-01

Background: Numerous studies document support for sexuality education in the schools. However, there is a dearth of research assessing support for sexual health services offered through school-based health clinics (SBHCs). The purpose of this study was to assess voter support for offering 3 sexual health services (STI/HIV testing, STI/HIV…

Data management in clinical research: Synthesizing stakeholder perspectives.

PubMed

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

Translating research findings to clinical nursing practice.

PubMed

Curtis, Kate; Fry, Margaret; Shaban, Ramon Z; Considine, Julie

2017-03-01

To describe the importance of, and methods for, successfully conducting and translating research into clinical practice. There is universal acknowledgement that the clinical care provided to individuals should be informed on the best available evidence. Knowledge and evidence derived from robust scholarly methods should drive our clinical practice, decisions and change to improve the way we deliver care. Translating research evidence to clinical practice is essential to safe, transparent, effective and efficient healthcare provision and meeting the expectations of patients, families and society. Despite its importance, translating research into clinical practice is challenging. There are more nurses in the frontline of health care than any other healthcare profession. As such, nurse-led research is increasingly recognised as a critical pathway to practical and effective ways of improving patient outcomes. However, there are well-established barriers to the conduct and translation of research evidence into practice. This clinical practice discussion paper interprets the knowledge translation literature for clinicians interested in translating research into practice. This paper is informed by the scientific literature around knowledge translation, implementation science and clinician behaviour change, and presented from the nurse clinician perspective. We provide practical, evidence-informed suggestions to overcome the barriers and facilitate enablers of knowledge translation. Examples of nurse-led research incorporating the principles of knowledge translation in their study design that have resulted in improvements in patient outcomes are presented in conjunction with supporting evidence. Translation should be considered in research design, including the end users and an evaluation of the research implementation. The success of research implementation in health care is dependent on clinician/consumer behaviour change and it is critical that implementation strategy

Expanding the PACS archive to support clinical review, research, and education missions

NASA Astrophysics Data System (ADS)

Honeyman-Buck, Janice C.; Frost, Meryll M.; Drane, Walter E.

1999-07-01

Designing an image archive and retrieval system that supports multiple users with many different requirements and patterns of use without compromising the performance and functionality required by diagnostic radiology is an intellectual and technical challenge. A diagnostic archive, optimized for performance when retrieving diagnostic images for radiologists needed to be expanded to support a growing clinical review network, the University of Florida Brain Institute's demands for neuro-imaging, Biomedical Engineering's imaging sciences, and an electronic teaching file. Each of the groups presented a different set of problems for the designers of the system. In addition, the radiologists did not want to see nay loss of performance as new users were added.

A medical informatics perspective on clinical decision support systems. Findings from the yearbook 2013 section on decision support.

PubMed

Bouaud, J; Lamy, J-B

2013-01-01

To summarize excellent research and to select best papers published in 2012 in the field of computer-based decision support in healthcare. A bibliographic search focused on clinical decision support systems (CDSSs) and computer provider order entry was performed, followed by a double-blind literature review. The review process yielded six papers, illustrating various aspects of clinical decision support. The first paper is a systematic review of CDSS intervention trials in real settings, and considers different types of possible outcomes. It emphasizes the heterogeneity of studies and confirms that CDSSs can improve process measures but that evidence lacks for other types of outcomes, especially clinical or economic. Four other papers tackle the safety of drug prescribing and show that CDSSs can be efficient in reducing prescription errors. The sixth paper exemplifies the growing role of ontological resources which can be used for several applications including decision support. CDSS research has to be continuously developed and assessed. The wide variety of systems and of interventions limits the understanding of factors of success of CDSS implementations. A standardization in the characterization of CDSSs and of intervention trial reporting will help to overcome this obstacle.

Collaborating With Businesses to Support and Sustain Research.

PubMed

Moch, Susan Diemert; Jansen, Debra A; Jadack, Rosemary A; Page, Phil; Topp, Robert

2015-10-01

Financial assistance is necessary for sustaining research at universities. Business collaborations are a potential means for obtaining these funds. To secure funding, understanding the process for obtaining these business funds is important for nursing faculty members. Although faculty rarely request funding from businesses, they are often in a position to solicit financial support due to existing relationships with clinical agency administrators, staff, and community leaders. The economic support received from businesses provides outcomes in nursing research, research education, academic-service partnerships, and client health care. This article describes the steps and processes involved in successfully obtaining research funding from businesses. In addition, case examples for securing and maintaining funding from health care agencies (evidence-based practice services) and from a health manufacturing company (product evaluation) are used to demonstrate the process. © The Author(s) 2015.

Tools in a clinical information system supporting clinical trials at a Swiss University Hospital.

PubMed

Weisskopf, Michael; Bucklar, Guido; Blaser, Jürg

2014-12-01

Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient-trial-assignment-tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of

Supportive and Palliative Care Research Clinical Trials | Division of Cancer Prevention

Cancer.gov

The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

Why the Medical Research Council refused Robert Edwards and Patrick Steptoe support for research on human conception in 1971

PubMed Central

Johnson, Martin H.; Franklin, Sarah B.; Cottingham, Matthew; Hopwood, Nick

2010-01-01

BACKGROUND In 1971, Cambridge physiologist Robert Edwards and Oldham gynaecologist Patrick Steptoe applied to the UK Medical Research Council (MRC) for long-term support for a programme of scientific and clinical ‘Studies on Human Reproduction’. The MRC, then the major British funder of medical research, declined support on ethical grounds and maintained this policy throughout the 1970s. The work continued with private money, leading to the birth of Louise Brown in 1978 and transforming research in obstetrics, gynaecology and human embryology. METHODS The MRC decision has been criticized, but the processes by which it was reached have yet to be explored. Here, we present an archive-based analysis of the MRC decision. RESULTS We find evidence of initial support for Edwards and Steptoe, including from within the MRC, which invited the applicants to join its new directly funded Clinical Research Centre at Northwick Park Hospital. They declined the offer, preferring long-term grant support at the University of Cambridge, and so exposed the project to competitive funding mode. Referees and the Clinical Research Board saw the institutional set-up in Cambridge as problematic with respect to clinical facilities and patient management; gave infertility a low priority compared with population control; assessed interventions as purely experimental rather than potential treatments, and so set the bar for safety high; feared fatal abnormalities and so wanted primate experiments first; and were antagonized by the applicants’ high media profile. The rejection set MRC policy on IVF for 8 years, until, after the birth of just two healthy babies, the Council rapidly converted to enthusiastic support. CONCLUSIONS This analysis enriches our view of a crucial decision, highlights institutional opportunities and constraints and provides insight into the then dominant attitudes of reproductive scientists and clinicians towards human conception research. PMID:20657027

How disease advocacy organizations participate in clinical research: a survey of genetic organizations.

PubMed

Landy, David C; Brinich, Margaret A; Colten, Mary Ellen; Horn, Elizabeth J; Terry, Sharon F; Sharp, Richard R

2012-02-01

Disease advocacy organizations may assist in the conduct of research in a variety of ways. We sought to characterize how disease advocacy organizations participate in clinical research and perceive their contributions. Postal and electronic surveys administered to leaders of disease advocacy organizations for genetic conditions identified through the Genetic Alliance's Disease InfoSearch. Of the 201 disease advocacy organizations approached, 124 (62%) responded. In the past 2 years, 91% of these organizations had assisted in participant recruitment, 75% collected data, 60% provided a researcher with financial support, and 56% assisted with study design. Forty-five percent of these organizations also supported a research registry or biobank. Few disease advocacy organization leaders (12%) reported regrets about research studies they had supported. Most (68%) felt their involvement in clinical research had increased the amount of research on their condition and that researchers should consult organizations like theirs in deciding how to recruit participants (58%) and in selecting research topics (56%). In addition to providing financial support, disease advocacy organizations participate directly in multiple aspects of research, ranging from study design and patient recruitment to data collection and analysis. Leaders of these organizations feel strongly that scientists and research sponsors should engage them as partners in the conduct of clinical research.

Using Competencies to Transform Clinical Research Job Classifications

ERIC Educational Resources Information Center

Brouwer, Rebecca Namenek; Deeter, Christine; Hannah, Deborah; Ainsworth, Terry; Mullen, Catherine; Hames, Betsy; Gaudaur, Heather; McKellar, Tara; Snyder, Denise C.

2017-01-01

The field of clinical research has changed considerably in the past 20 years. As the work in this realm has come to embody far more than the pursuit of improved patient care, this has meant that staff supporting the research are asked to take on additional responsibilities, learn new processes, and be continuously educated on modernized policies…

Bridging the Gap: Supporting Translational Research Careers Through an Integrated Research Track Within Residency Training

PubMed Central

Arbuckle, Melissa R.; Gordon, Joshua A.; Pincus, Harold A.; Oquendo, Maria A.

2013-01-01

In the setting of traditional residency training programs, physician–scientists are often limited in their ability to pursue research training goals while meeting clinical training requirements. This creates a gap in research training at a critical developmental stage. In response, Columbia University Medical Center’s Department of Psychiatry, in partnership with the New York State Psychiatric Institute, has created a formal Research Track Program (RTP) for psychiatry residents so that interested individuals can maintain their attention on research training during formative residency years. Clinical and research training are integrated through core clinical rotations on research units. With protected research time and clear developmental milestones for each year of training, the RTP allows research track residents to meet both clinical and research training goals while maintaining a healthy work–life balance. In coordination with existing postdoctoral research fellowship programs, research track residents can effectively jump-start fellowship training with advanced course work and consistent, continuous mentorship bridging residency and fellowship years. A key element of the program is its provision of core training in research literacy and extensive research opportunities for all residents, stimulating research interest across the whole residency program. Supported by the National Institutes of Health and a private foundation, this RTP capitalizes on a unique academic–private partnership to address many of the challenges facing physician–scientists. By integrating clinical and research exposures and offering protected research time, careful mentoring, and financial resources, the program aims to further the development of those most poised to establish careers in translational research. PMID:23619070

Information warehouse - a comprehensive informatics platform for business, clinical, and research applications.

PubMed

Kamal, Jyoti; Liu, Jianhua; Ostrander, Michael; Santangelo, Jennifer; Dyta, Ravi; Rogers, Patrick; Mekhjian, Hagop S

2010-11-13

Since its inception in 1997, the IW (Information Warehouse) at the Ohio State University Medical Center (OSUMC) has gradually transformed itself from a single purpose business decision support system to a comprehensive informatics platform supporting basic, clinical, and translational research. The IW today is the combination of four integrated components: a clinical data repository containing over a million patients; a research data repository housing various research specific data; an application development platform for building business and research enabling applications; a business intelligence environment assisting in reporting in all function areas. The IW is structured and encoded using standard terminologies such as SNOMED-CT, ICD, and CPT. The IW is an important component of OSUMC's Clinical and Translational Science Award (CTSA) informatics program.

Clinical decision support for genetically guided personalized medicine: a systematic review

PubMed Central

Welch, Brandon M

2013-01-01

Objective To review the literature on clinical decision support (CDS) for genetically guided personalized medicine (GPM). Materials and Methods MEDLINE and Embase were searched from 1990 to 2011. The manuscripts included were summarized, and notable themes and trends were identified. Results Following a screening of 3416 articles, 38 primary research articles were identified. Focal areas of research included family history-driven CDS, cancer management, and pharmacogenomics. Nine randomized controlled trials of CDS interventions for GPM were identified, seven of which reported positive results. The majority of manuscripts were published on or after 2007, with increased recent focus on genotype-driven CDS and the integration of CDS within primary clinical information systems. Discussion Substantial research has been conducted to date on the use of CDS to enable GPM. In a previous analysis of CDS intervention trials, the automatic provision of CDS as a part of routine clinical workflow had been identified as being critical for CDS effectiveness. There was some indication that CDS for GPM could potentially be effective without the CDS being provided automatically, but we did not find conclusive evidence to support this hypothesis. Conclusion To maximize the clinical benefits arising from ongoing discoveries in genetics and genomics, additional research and development is recommended for identifying how best to leverage CDS to bridge the gap between the promise and realization of GPM. PMID:22922173

An Integrative Review of Engaging Clinical Nurses in Nursing Research.

PubMed

Scala, Elizabeth; Price, Carrie; Day, Jennifer

2016-07-01

To review the literature for best practices for engaging clinical nurses in nursing research. Review of the research and nonresearch papers published between 2005 and 2015 that answered the evidence-based practice (EBP) question: what are the best practices for engaging clinical nursing staff in nursing research? PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Joanna Briggs Institute, and Cochrane were searched using a combination of controlled vocabulary and key words. Nineteen papers that answered the EBP question were selected for review. It can be difficult to involve clinical nurses in research. There are multiple factors to consider when nursing leadership looks to engage clinical nurses in nursing research. Nurse leaders can take many approaches to engage clinical nurses in research. Each organization must perform its own assessment to identify areas of opportunity. Nursing leadership can take these areas of opportunity to structure a multifaceted approach to support clinical staff in the conduct and dissemination of nursing research. The evidence from this review offers EBP recommendations as well as reports on the gaps in the literature related to best practices for engaging clinical nurses in nursing research. © 2016 Sigma Theta Tau International.

Crossing the "digital divide:" implementing an electronic medical record system in a rural Kenyan health center to support clinical care and research.

PubMed

Tierney, William M; Rotich, Joseph K; Smith, Faye E; Bii, John; Einterz, Robert M; Hannan, Terry J

2002-01-01

To improve care, one must measure it. In the US, electronic medical record systems have been installed in many institutions to support health care management, quality improvement, and research. Developing countries lack such systems and thus have difficulties managing scarce resources and investigating means of improving health care delivery and outcomes. We describe the implementation and use of the first documented electronic medical record system in ambulatory care in sub-Saharan Africa. After one year, it has captured data for more than 13,000 patients making more than 26,000 visits. We present lessons learned and modifications made to this system to improve its capture of data and ability to support a comprehensive clinical care and research agenda.

Considerations for planning and conducting clinic-based research in physical therapy.

PubMed

Fitzgerald, G K; Delitto, A

2001-08-01

There is growing demand to increase the volume of clinic-based research in physical therapy. Special considerations, unique to the planning and conduct of clinic-based research, need to be addressed to increase the likelihood that these studies will be completed successfully. The purposes of this perspective are to discuss factors affecting clinic-based research and to offer suggestions for addressing these problems when designing and conducting research studies in a clinical setting. This perspective discusses issues such as patient management, determining the availability of target patient populations, acquiring support from physical therapists and physicians, reporting and managing research-related injury or illness, and modifying or terminating projects. Some of the points made in this perspective are illustrated using examples from the authors' experiences in conducting clinical research.

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

PubMed

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.

A New Framework and Prototype Solution for Clinical Decision Support and Research in Genomics and Other Data-intensive Fields of Medicine.

PubMed

Evans, James P; Wilhelmsen, Kirk C; Berg, Jonathan; Schmitt, Charles P; Krishnamurthy, Ashok; Fecho, Karamarie; Ahalt, Stanley C

2016-01-01

In genomics and other fields, it is now possible to capture and store large amounts of data in electronic medical records (EMRs). However, it is not clear if the routine accumulation of massive amounts of (largely uninterpretable) data will yield any health benefits to patients. Nevertheless, the use of large-scale medical data is likely to grow. To meet emerging challenges and facilitate optimal use of genomic data, our institution initiated a comprehensive planning process that addresses the needs of all stakeholders (e.g., patients, families, healthcare providers, researchers, technical staff, administrators). Our experience with this process and a key genomics research project contributed to the proposed framework. We propose a two-pronged Genomic Clinical Decision Support System (CDSS) that encompasses the concept of the "Clinical Mendeliome" as a patient-centric list of genomic variants that are clinically actionable and introduces the concept of the "Archival Value Criterion" as a decision-making formalism that approximates the cost-effectiveness of capturing, storing, and curating genome-scale sequencing data. We describe a prototype Genomic CDSS that we developed as a first step toward implementation of the framework. The proposed framework and prototype solution are designed to address the perspectives of stakeholders, stimulate effective clinical use of genomic data, drive genomic research, and meet current and future needs. The framework also can be broadly applied to additional fields, including other '-omics' fields. We advocate for the creation of a Task Force on the Clinical Mendeliome, charged with defining Clinical Mendeliomes and drafting clinical guidelines for their use.

A New Framework and Prototype Solution for Clinical Decision Support and Research in Genomics and Other Data-intensive Fields of Medicine

PubMed Central

Evans, James P.; Wilhelmsen, Kirk C.; Berg, Jonathan; Schmitt, Charles P.; Krishnamurthy, Ashok; Fecho, Karamarie; Ahalt, Stanley C.

2016-01-01

Introduction: In genomics and other fields, it is now possible to capture and store large amounts of data in electronic medical records (EMRs). However, it is not clear if the routine accumulation of massive amounts of (largely uninterpretable) data will yield any health benefits to patients. Nevertheless, the use of large-scale medical data is likely to grow. To meet emerging challenges and facilitate optimal use of genomic data, our institution initiated a comprehensive planning process that addresses the needs of all stakeholders (e.g., patients, families, healthcare providers, researchers, technical staff, administrators). Our experience with this process and a key genomics research project contributed to the proposed framework. Framework: We propose a two-pronged Genomic Clinical Decision Support System (CDSS) that encompasses the concept of the “Clinical Mendeliome” as a patient-centric list of genomic variants that are clinically actionable and introduces the concept of the “Archival Value Criterion” as a decision-making formalism that approximates the cost-effectiveness of capturing, storing, and curating genome-scale sequencing data. We describe a prototype Genomic CDSS that we developed as a first step toward implementation of the framework. Conclusion: The proposed framework and prototype solution are designed to address the perspectives of stakeholders, stimulate effective clinical use of genomic data, drive genomic research, and meet current and future needs. The framework also can be broadly applied to additional fields, including other ‘-omics’ fields. We advocate for the creation of a Task Force on the Clinical Mendeliome, charged with defining Clinical Mendeliomes and drafting clinical guidelines for their use. PMID:27195307

Clinical Research Methodology 2: Observational Clinical Research.

PubMed

Sessler, Daniel I; Imrey, Peter B

2015-10-01

Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation-in addition to errors of chance. Confounding can be statistically controlled to the extent that potential factors are known and accurately measured, but, in practice, bias and unknown confounders usually remain additional potential sources of error, often of unknown magnitude and clinical impact. Causality-the most clinically useful relation between exposure and outcome-can rarely be definitively determined from observational studies because intentional, controlled manipulations of exposures are not involved. In this article, we review several types of observational clinical research: case series, comparative case-control and cohort studies, and hybrid designs in which case-control analyses are performed on selected members of cohorts. We also discuss the analytic issues that arise when groups to be compared in an observational study, such as patients receiving different therapies, are not comparable in other respects.

Commentary: recognizing and tracking philanthropy's critical support of health research.

PubMed

Bond, Queta; Gallin, Elaine K

2012-11-01

Given the current fiscal climate limiting both government and industry support for health research, philanthropic support of health research is increasingly relevant because it provides some of the critical "risk capital" that stimulates innovation, helps translate basic research findings into clinical applications, helps support the career development of investigators, builds new infrastructure, and helps fill key funding gaps. Unfortunately, because of the philanthropic sector's diversity and scope, it is challenging to track the sector's health research investments. The authors briefly review the landscape of philanthropic organizations, identify several success stories resulting from philanthropic investments, and finally underscore the importance of gaining more knowledge about the sector through purposeful data collection efforts such as those of the Health Research Alliance (HRA), a consortium of nonprofit funders of biomedical research and training. Recent HRA efforts of this type are highlighted in this commentary and described in detail in the report by Myers et al in this issue of Academic Medicine.

A model for the electronic support of practice-based research networks.

PubMed

Peterson, Kevin A; Delaney, Brendan C; Arvanitis, Theodoros N; Taweel, Adel; Sandberg, Elisabeth A; Speedie, Stuart; Richard Hobbs, F D

2012-01-01

The principal goal of the electronic Primary Care Research Network (ePCRN) is to enable the development of an electronic infrastructure to support clinical research activities in primary care practice-based research networks (PBRNs). We describe the model that the ePCRN developed to enhance the growth and to expand the reach of PBRN research. Use cases and activity diagrams were developed from interviews with key informants from 11 PBRNs from the United States and United Kingdom. Discrete functions were identified and aggregated into logical components. Interaction diagrams were created, and an overall composite diagram was constructed describing the proposed software behavior. Software for each component was written and aggregated, and the resulting prototype application was pilot tested for feasibility. A practical model was then created by separating application activities into distinct software packages based on existing PBRN business rules, hardware requirements, network requirements, and security concerns. We present an information architecture that provides for essential interactions, activities, data flows, and structural elements necessary for providing support for PBRN translational research activities. The model describes research information exchange between investigators and clusters of independent data sites supported by a contracted research director. The model was designed to support recruitment for clinical trials, collection of aggregated anonymous data, and retrieval of identifiable data from previously consented patients across hundreds of practices. The proposed model advances our understanding of the fundamental roles and activities of PBRNs and defines the information exchange commonly used by PBRNs to successfully engage community health care clinicians in translational research activities. By describing the network architecture in a language familiar to that used by software developers, the model provides an important foundation for the

Funding agencies and disease organizations: resources and recommendations to facilitate ALS clinical research.

PubMed

Chad, David A; Bidichandani, Sanjay; Bruijn, Lucie; Capra, J Donald; Dickie, Brian; Ferguson, John; Figlewicz, Denise; Forsythe, Melissa; Kaufmann, Petra; Kirshner, Annette; Monti, William

2013-05-01

Ten groups presented their perspectives on facilitating clinical research in ALS including four federal agencies, four disease organizations, one foundation and one advocacy group. The federal agencies (National Institute of Neurological Disorders and Stroke, National Institute of Environmental Health Sciences, Office of Rare Diseases Research, Department of Defense) encourage fostering a team approach between pre-clinical and clinical research investigators, coordinating with patient groups in the early phases of clinical studies, enhancing private and public partnerships, and investigating the interplay between genetic susceptibility and environmental exposure. The disease organizations (Muscular Dystrophy Association, ALS Association, ALS Society of Canada, and the Motor Neurone Disease Association UK) support fellowship training programs to develop ALS clinician scientists, and encourage work on the epidemiology of ALS, on genetic and epigenetic mechanisms that are relevant to ALS pathogenesis, on developing ALS registries and biobanks, and building bridges of collaboration among study groups. The Foundation supports innovative projects, including stem-cell research, and Patient Advocacy is committed to supporting excellence in ALS research and patient care, and believes strongly in enhancing communication between patients and members of the research community.

A metadata schema for data objects in clinical research.

PubMed

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.

The value of participatory development to support antimicrobial stewardship with a clinical decision support system.

PubMed

Beerlage-de Jong, Nienke; Wentzel, Jobke; Hendrix, Ron; van Gemert-Pijnen, Lisette

2017-04-01

Current clinical decision support systems (CDSSs) for antimicrobial stewardship programs (ASPs) are guideline- or expert-driven. They are focused on (clinical) content, not on supporting real-time workflow. Thus, CDSSs fail to optimally support prudent antimicrobial prescribing in daily practice. Our aim was to demonstrate why and how participatory development (involving end-users and other stakeholders) can contribute to the success of CDSSs in ASPs. A mixed-methods approach was applied, combining scenario-based prototype evaluations (to support verbalization of work processes and out-of-the-box thinking) among 6 medical resident physicians with an online questionnaire (to cross-reference findings of the prototype evaluations) among 54 Dutch physicians. The prototype evaluations resulted in insight into the end-users and their way of working, as well as their needs and expectations. The online questionnaire that was distributed among a larger group of medical specialists, including lung and infection experts, complemented the findings of the prototype evaluations. It revealed a say/do problem concerning the unrecognized need of support for selecting diagnostic tests. Low-fidelity prototypes of a technology allow researchers to get to know the end-users, their way of working, and their work context. Involving experts allows technology developers to continuously check the fit between technology and clinical practice. The combination enables the participatory development of technology to successfully support ASPs. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Interventions to support and develop clinician-researcher leadership in one health district.

PubMed

Fry, Margaret; Dombkins, Anthony

2017-07-10

Purpose Clinical leadership, researcher capacity and a culture of clinical inquiry are needed in the clinical workforce. The purpose of this paper is to report on a program which was used to develop and support clinicians to explore practice, implement innovation, translate evidence and build researcher capacity. Design/methodology/approach This pragmatic paper presents a case study of a nursing and midwifery clinician-researcher development program. The multi-site, multi-modal program focused on education, mentoring and support, communication networks, and clinician-university partnerships strategies to build workforce capacity and leadership. Findings Over 2,000 staff have been involved in the program representing a range of health disciplines. The study day program has been delivered to 500 participants with master classes having over 1,500 attendees. The research mentor program has demonstrated that participants increased their confidence for research leadership roles and are pursuing research and quality assurance projects. Communication strategies improved the visibility of nursing and midwifery. Research limitations/implications This case study was conducted in one health district, which may not have relevance to other geographical areas. The small numbers involved in the research mentor program need to be considered when reviewing the findings. Practical implications The program has been a catalyst for developing a research culture, clinical leadership and research networks that strengthen workforce capacity. Building researcher skills in the workforce will better support quality healthcare and the examination of everyday practice. Social implications Building a culture of healthcare that is based on inquiry and evidence-based practice will lead to more appropriate and consistent healthcare delivery. Consumers have the right to expect health clinicians will challenge everyday practice and have the skills and capability to translate or generate best evidence

Research leadership: should clinical directors be distinguished researchers?

PubMed

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

2016-06-01

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

Information management to enable personalized medicine: stakeholder roles in building clinical decision support.

PubMed

Downing, Gregory J; Boyle, Scott N; Brinner, Kristin M; Osheroff, Jerome A

2009-10-08

Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies. Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures), and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine. This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In addition, to represent meaningful benefits to personalized

Information management to enable personalized medicine: stakeholder roles in building clinical decision support

PubMed Central

2009-01-01

Background Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies. Discussion Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures), and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine. Summary This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In addition, to represent

The Rare Diseases Clinical Research Network's organization and approach to observational research and health outcomes research.

PubMed

Krischer, Jeffrey P; Gopal-Srivastava, Rashmi; Groft, Stephen C; Eckstein, David J

2014-08-01

Established in 2003 by the Office of Rare Diseases Research (ORDR), in collaboration with several National Institutes of Health (NIH) Institutes/Centers, the Rare Diseases Clinical Research Network (RDCRN) consists of multiple clinical consortia conducting research in more than 200 rare diseases. The RDCRN supports longitudinal or natural history, pilot, Phase I, II, and III, case-control, cross-sectional, chart review, physician survey, bio-repository, and RDCRN Contact Registry (CR) studies. To date, there have been 24,684 participants enrolled on 120 studies from 446 sites worldwide. An additional 11,533 individuals participate in the CR. Through a central data management and coordinating center (DMCC), the RDCRN's platform for the conduct of observational research encompasses electronic case report forms, federated databases, and an online CR for epidemiological and survey research. An ORDR-governed data repository (through dbGaP, a database for genotype and phenotype information from the National Library of Medicine) has been created. DMCC coordinates with ORDR to register and upload study data to dbGaP for data sharing with the scientific community. The platform provided by the RDCRN DMCC has supported 128 studies, six of which were successfully conducted through the online CR, with 2,352 individuals accrued and a median enrollment time of just 2 months. The RDCRN has built a powerful suite of web-based tools that provide for integration of federated and online database support that can accommodate a large number of rare diseases on a global scale. RDCRN studies have made important advances in the diagnosis and treatment of rare diseases.

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

PubMed

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/.

Platelet Immunology in China: Research and Clinical Applications.

PubMed

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.

Citation analysis of Canadian psycho-oncology and supportive care researchers.

PubMed

Hack, Thomas F; Crooks, Dauna; Plohman, James; Kepron, Emma

2014-02-01

The purpose of this study was to conduct a historical review of psycho-oncology and supportive care research in Canada using citation analysis and to review the clinical impact of the research conducted by the most highly cited researchers. The lifetime journal publication records of 109 psycho-oncology and supportive care researchers in Canada were subject to citation analysis using the Scopus database, based on citations since 1996 of articles deemed relevant to psychosocial oncology and supportive care, excluding self-citations. Three primary types of analysis were performed for each individual: the number of citations for each journal publication, a summative citation count of all published articles, and the Scopus h-index. The top 20 psycho-oncology/supportive care researchers for each of five citation categories are presented: the number of citations for all publications; the number of citations for first-authored publications; the most highly cited first-authored publications; the Scopus h-index for all publications; and the Scopus h-index for first-authored publications. The three most highly cited Canadian psycho-oncology researchers are Dr. Kerry Courneya (University of Alberta), Dr. Lesley Degner, (University of Manitoba), and Dr. Harvey Chochinov (University of Manitoba). Citation analysis is useful for examining the research performance of psycho-oncology and supportive care researchers and identifying leaders among them.

2017 EULAR recommendations for a core data set to support observational research and clinical care in rheumatoid arthritis.

PubMed

Radner, Helga; Chatzidionysiou, Katerina; Nikiphorou, Elena; Gossec, Laure; Hyrich, Kimme L; Zabalan, Condruta; van Eijk-Hustings, Yvonne; Williamson, Paula R; Balanescu, Andra; Burmester, Gerd R; Carmona, Loreto; Dougados, Maxime; Finckh, Axel; Haugeberg, Glenn; Hetland, Merete Lund; Oliver, Susan; Porter, Duncan; Raza, Karim; Ryan, Patrick; Santos, Maria Jose; van der Helm-van Mil, Annette; van Riel, Piet; von Krause, Gabrielle; Zavada, Jakub; Dixon, William G; Askling, Johan

2018-04-01

Personalised medicine, new discoveries and studies on rare exposures or outcomes require large samples that are increasingly difficult for any single investigator to obtain. Collaborative work is limited by heterogeneities, both what is being collected and how it is defined. To develop a core set for data collection in rheumatoid arthritis (RA) research which (1) allows harmonisation of data collection in future observational studies, (2) acts as a common data model against which existing databases can be mapped and (3) serves as a template for standardised data collection in routine clinical practice to support generation of research-quality data. A multistep, international multistakeholder consensus process was carried out involving voting via online surveys and two face-to-face meetings. A core set of 21 items ('what to collect') and their instruments ('how to collect') was agreed: age, gender, disease duration, diagnosis of RA, body mass index, smoking, swollen/tender joints, patient/evaluator global, pain, quality of life, function, composite scores, acute phase reactants, serology, structural damage, treatment and comorbidities. The core set should facilitate collaborative research, allow for comparisons across studies and harmonise future data from clinical practice via electronic medical record systems. © 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.

Information Warehouse – A Comprehensive Informatics Platform for Business, Clinical, and Research Applications

PubMed Central

Kamal, Jyoti; Liu, Jianhua; Ostrander, Michael; Santangelo, Jennifer; Dyta, Ravi; Rogers, Patrick; Mekhjian, Hagop S.

2010-01-01

Since its inception in 1997, the IW (Information Warehouse) at the Ohio State University Medical Center (OSUMC) has gradually transformed itself from a single purpose business decision support system to a comprehensive informatics platform supporting basic, clinical, and translational research. The IW today is the combination of four integrated components: a clinical data repository containing over a million patients; a research data repository housing various research specific data; an application development platform for building business and research enabling applications; a business intelligence environment assisting in reporting in all function areas. The IW is structured and encoded using standard terminologies such as SNOMED-CT, ICD, and CPT. The IW is an important component of OSUMC’s Clinical and Translational Science Award (CTSA) informatics program. PMID:21347019

Comparative audit of clinical research in pediatric neurology.

PubMed

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 < .0001), and multidisciplinary team (69.9% vs 87%; P = .003) was observed. In terms of specific study design, a significant decline in case reports (34.3% vs 10.3%; P < .0001) and an increase in case-control studies (11.3% vs 22.9%; P = .02) were evident over the 10-year interval. This comparative audit revealed that there has been a discernible change in the methodology profile of clinical research in child neurology over a decade. Trends apparently suggest a more rigorous approach to study design and investigation in this field.

Open source clinical portals: a model for healthcare information systems to support care processes and feed clinical research. An Italian case of design, development, reuse, and exploitation.

PubMed

Locatelli, Paolo; Baj, Emanuele; Restifo, Nicola; Origgi, Gianni; Bragagia, Silvia

2011-01-01

Open source is a still unexploited chance for healthcare organizations and technology providers to answer to a growing demand for innovation and to join economical benefits with a new way of managing hospital information systems. This chapter will present the case of the web enterprise clinical portal developed in Italy by Niguarda Hospital in Milan with the support of Fondazione Politecnico di Milano, to enable a paperless environment for clinical and administrative activities in the ward. This represents also one rare case of open source technology and reuse in the healthcare sector, as the system's porting is now taking place at Besta Neurological Institute in Milan. This institute is customizing the portal to feed researchers with structured clinical data collected in its portal's patient records, so that they can be analyzed, e.g., through business intelligence tools. Both organizational and clinical advantages are investigated, from process monitoring, to semantic data structuring, to recognition of common patterns in care processes.

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

PubMed

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

2010-04-01

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

Involving patients in clinical research: the Telescot Patient Panel.

PubMed

Fairbrother, Peter; McCloughan, Lucy; Adam, Geraldine; Brand, Richard; Brown, Cecil; Watson, Mary; Cotter, Nicola; Mackellaig, Juliet; McKinstry, Brian

2016-06-01

To date, patient involvement in the development of clinical research work has been limited. In 2011, the Telescot research team commenced work on a feasibility trial to investigate home telemonitoring of blood pressure for people who have experienced stroke or transient ischaemic attack (TIA). The team decided to involve patients in the development of the research. To improve research design through patient involvement. A modified form of the 'Scrutiny Panel' approach was used to involve people who had stroke in the research project. The Patient Panel supported the research in three key ways: it informed patient communication; it presented patient perspectives on the applicability and usability of the intervention; and it guided the development of the qualitative study. The initiative was considered a positive experience for all. However, challenges were identified in terms of the time and cost implications of undertaking patient involvement. Importance is attached to adequate project planning and development, partnership working with community-based organizations and the necessity for clear role delineation between patients and professionals to enable effective collaborative working. The Telescot Patient Panel was beneficial in supporting the development of the feasibility trial. The Panel approach was considered transferable to other clinical research contexts. © 2013 John Wiley & Sons Ltd.

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

PubMed

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

2013-12-01

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

[The Coordinating Centers for Clinical Trials (KKS) and the KKS Network: competence for clinical research].

PubMed

Ohmann, Christian; Bruns, Insa; Wolff, Stephanie

2010-01-01

The Network of the Coordination Centers for Clinical Trials (CTCs; Koordinierungszentren für Klinische Studien(KKS)) comprises 17 institutions working as scientific service provider for universities, study groups, the pharmaceutical and medical devices industry as well as additional clients associated with clinical research. The CTCs have established planning and conduct of clinical trials according to Good Clinical Practice (GCP) guidelines,with a wide range of study support in academia. One focus according to indications is cancer. Expertise in hematological/oncological research can be requested nationwide and cross-institutional. The KKS network currently cooperates with medical societies and other, even European networks in 20 countries and has been established as a strong platform for oncological trials. Copyright © 2010 S. Karger AG, Basel.

Mistrust of Pediatric Sickle Cell Disease Clinical Trials Research

PubMed Central

Stevens, Evelyn M.; Patterson, Chavis A.; Li, Yimei B.; Smith-Whitley, Kim; Barakat, Lamia P.

2016-01-01

Introduction Sickle cell disease (SCD) research is hampered by disparities in participation due in part to mistrust of research among racial/ethnic minorities. Beyond the historic context of research misconduct, little is known about the associations of social ecologic factors with mistrust and of mistrust with SCD clinical trials enrollment. This study evaluated proximal (age, gender, disease severity, perceived stress, SES) and distal (religious beliefs, social support, instrumental support) factors related to mistrust of research among caregivers of children with SCD and adolescents and young adults (AYAs) with SCD. Methods Over an 18-month period (2009–2010), participants completed questionnaires of perceived barriers and benefits to clinical trials enrollment, perceived stress, and self-reported demographic and disease-related information. Analyses (January–June 2015) used multivariable linear regressions to evaluate predictors of mistrust. Results Data were analyzed for 154 caregivers (mean age, 38.75 years; SD=9.56 years; 90.30% female) and 88 AYAs (mean age, 24.76 years; SD=7.25 years; 46.40% female). Among caregivers (full model, R2=0.14, p≤0.001), greater mistrust was explained by higher perceived stress (β=0.04, p=0.052), religious beliefs (β=0.61, p≤0.001), and greater instrumental support (β=0.07, p=0.044). Among AYAs (full model, R2=0.18, p≤0.001), higher mistrust was explained by being male and lower instrumental support (β= −0.56, p≤0.001; β= −0.11, p=0.016, respectively). Mistrust was significantly greater among caregivers that reported no prior involvement in medical research (p=0.003). Conclusions By understanding the complexity through which social ecologic factors contribute to mistrust, researchers may create targeted strategies to address mistrust and increase engagement in SCD research for caregivers and AYAs. PMID:27320470

Recent Advances in Clinical Natural Language Processing in Support of Semantic Analysis.

PubMed

Velupillai, S; Mowery, D; South, B R; Kvist, M; Dalianis, H

2015-08-13

We present a review of recent advances in clinical Natural Language Processing (NLP), with a focus on semantic analysis and key subtasks that support such analysis. We conducted a literature review of clinical NLP research from 2008 to 2014, emphasizing recent publications (2012-2014), based on PubMed and ACL proceedings as well as relevant referenced publications from the included papers. Significant articles published within this time-span were included and are discussed from the perspective of semantic analysis. Three key clinical NLP subtasks that enable such analysis were identified: 1) developing more efficient methods for corpus creation (annotation and de-identification), 2) generating building blocks for extracting meaning (morphological, syntactic, and semantic subtasks), and 3) leveraging NLP for clinical utility (NLP applications and infrastructure for clinical use cases). Finally, we provide a reflection upon most recent developments and potential areas of future NLP development and applications. There has been an increase of advances within key NLP subtasks that support semantic analysis. Performance of NLP semantic analysis is, in many cases, close to that of agreement between humans. The creation and release of corpora annotated with complex semantic information models has greatly supported the development of new tools and approaches. Research on non-English languages is continuously growing. NLP methods have sometimes been successfully employed in real-world clinical tasks. However, there is still a gap between the development of advanced resources and their utilization in clinical settings. A plethora of new clinical use cases are emerging due to established health care initiatives and additional patient-generated sources through the extensive use of social media and other devices.

Recent Advances in Clinical Natural Language Processing in Support of Semantic Analysis

PubMed Central

Mowery, D.; South, B. R.; Kvist, M.; Dalianis, H.

2015-01-01

Summary Objectives We present a review of recent advances in clinical Natural Language Processing (NLP), with a focus on semantic analysis and key subtasks that support such analysis. Methods We conducted a literature review of clinical NLP research from 2008 to 2014, emphasizing recent publications (2012-2014), based on PubMed and ACL proceedings as well as relevant referenced publications from the included papers. Results Significant articles published within this time-span were included and are discussed from the perspective of semantic analysis. Three key clinical NLP subtasks that enable such analysis were identified: 1) developing more efficient methods for corpus creation (annotation and de-identification), 2) generating building blocks for extracting meaning (morphological, syntactic, and semantic subtasks), and 3) leveraging NLP for clinical utility (NLP applications and infrastructure for clinical use cases). Finally, we provide a reflection upon most recent developments and potential areas of future NLP development and applications. Conclusions There has been an increase of advances within key NLP subtasks that support semantic analysis. Performance of NLP semantic analysis is, in many cases, close to that of agreement between humans. The creation and release of corpora annotated with complex semantic information models has greatly supported the development of new tools and approaches. Research on non-English languages is continuously growing. NLP methods have sometimes been successfully employed in real-world clinical tasks. However, there is still a gap between the development of advanced resources and their utilization in clinical settings. A plethora of new clinical use cases are emerging due to established health care initiatives and additional patient-generated sources through the extensive use of social media and other devices. PMID:26293867

A Domain Analysis Model for eIRB Systems: Addressing the Weak Link in Clinical Research Informatics

PubMed Central

He, Shan; Narus, Scott P.; Facelli, Julio C.; Lau, Lee Min; Botkin, Jefferey R.; Hurdle, John F.

2014-01-01

Institutional Review Boards (IRBs) are a critical component of clinical research and can become a significant bottleneck due to the dramatic increase, in both volume and complexity of clinical research. Despite the interest in developing clinical research informatics (CRI) systems and supporting data standards to increase clinical research efficiency and interoperability, informatics research in the IRB domain has not attracted much attention in the scientific community. The lack of standardized and structured application forms across different IRBs causes inefficient and inconsistent proposal reviews and cumbersome workflows. These issues are even more prominent in multi-institutional clinical research that is rapidly becoming the norm. This paper proposes and evaluates a domain analysis model for electronic IRB (eIRB) systems, paving the way for streamlined clinical research workflow via integration with other CRI systems and improved IRB application throughput via computer-assisted decision support. PMID:24929181

The CTSA Consortium's Catalog of Assets for Translational and Clinical Health Research (CATCHR)

PubMed Central

Mapes, Brandy; Basford, Melissa; Zufelt, Anneliese; Wehbe, Firas; Harris, Paul; Alcorn, Michael; Allen, David; Arnim, Margaret; Autry, Susan; Briggs, Michael S.; Carnegie, Andrea; Chavis‐Keeling, Deborah; De La Pena, Carlos; Dworschak, Doris; Earnest, Julie; Grieb, Terri; Guess, Marilyn; Hafer, Nathaniel; Johnson, Tesheia; Kasper, Amanda; Kopp, Janice; Lockie, Timothy; Lombardo, Vincetta; McHale, Leslie; Minogue, Andrea; Nunnally, Beth; O'Quinn, Deanna; Peck, Kelly; Pemberton, Kieran; Perry, Cheryl; Petrie, Ginny; Pontello, Andria; Posner, Rachel; Rehman, Bushra; Roth, Deborah; Sacksteder, Paulette; Scahill, Samantha; Schieri, Lorri; Simpson, Rosemary; Skinner, Anne; Toussant, Kim; Turner, Alicia; Van der Put, Elaine; Wasser, June; Webb, Chris D.; Williams, Maija; Wiseman, Lori; Yasko, Laurel; Pulley, Jill

2014-01-01

Abstract The 61 CTSA Consortium sites are home to valuable programs and infrastructure supporting translational science and all are charged with ensuring that such investments translate quickly to improved clinical care. Catalog of Assets for Translational and Clinical Health Research (CATCHR) is the Consortium's effort to collect and make available information on programs and resources to maximize efficiency and facilitate collaborations. By capturing information on a broad range of assets supporting the entire clinical and translational research spectrum, CATCHR aims to provide the necessary infrastructure and processes to establish and maintain an open‐access, searchable database of consortium resources to support multisite clinical and translational research studies. Data are collected using rigorous, defined methods, with the resulting information made visible through an integrated, searchable Web‐based tool. Additional easy‐to‐use Web tools assist resource owners in validating and updating resource information over time. In this paper, we discuss the design and scope of the project, data collection methods, current results, and future plans for development and sustainability. With increasing pressure on research programs to avoid redundancy, CATCHR aims to make available information on programs and core facilities to maximize efficient use of resources. PMID:24456567

Infrastructure resources for clinical research in amyotrophic lateral sclerosis.

PubMed

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.

Using Clinical Decision Support Software in Health Insurance Company

NASA Astrophysics Data System (ADS)

Konovalov, R.; Kumlander, Deniss

This paper proposes the idea to use Clinical Decision Support software in Health Insurance Company as a tool to reduce the expenses related to Medication Errors. As a prove that this class of software will help insurance companies reducing the expenses, the research was conducted in eight hospitals in United Arab Emirates to analyze the amount of preventable common Medication Errors in drug prescription.

In Defense of a Social Value Requirement for Clinical Research

PubMed Central

Wendler, David; Rid, Annette

2017-01-01

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 paper 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. PMID:28060427

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

PubMed

Ross, Joseph S

2016-09-20

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

Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research.

PubMed

Heisler, Michele

2010-06-01

Much of diabetes care needs to be carried out by patients between office visits with their health care providers. Yet, many patients face difficulties carrying out these tasks. In addition, many adults with diabetes cannot count on effective support from their families and friends to help them with their self-management. Peer support programmes are a promising approach to enhance social and emotional support, assist patients in daily management and living with diabetes and promote linkages to clinical care. This background paper provides a brief overview of different approaches to mobilize peer support for diabetes self-management support, discusses evidence to date on the effectiveness of each of these models, highlights logistical and evaluation issues for each model and concludes with a discussion of directions for future research in this area.

Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research

PubMed Central

2010-01-01

Much of diabetes care needs to be carried out by patients between office visits with their health care providers. Yet, many patients face difficulties carrying out these tasks. In addition, many adults with diabetes cannot count on effective support from their families and friends to help them with their self-management. Peer support programmes are a promising approach to enhance social and emotional support, assist patients in daily management and living with diabetes and promote linkages to clinical care. This background paper provides a brief overview of different approaches to mobilize peer support for diabetes self-management support, discusses evidence to date on the effectiveness of each of these models, highlights logistical and evaluation issues for each model and concludes with a discussion of directions for future research in this area. PMID:19293400

Improving performance with clinical decision support.

PubMed

Brailer, D J; Goldfarb, S; Horgan, M; Katz, F; Paulus, R A; Zakrewski, K

1996-07-01

CADU/CIS (Clinical and Administrative Decision-support Utility and Clinical Information System) is a clinical decision-support workstation that allows large volumes of clinical information systems data to be analyzed in a timely and user-friendly fashion. CARE PROCESS MEASUREMENT: For any given disease, subgroups of patients are identified, and automated, customized "clinical pathways" are generated. For each subgroup, the best practice norms for use of test and therapies are identified. Practice style variations are then compared to outcomes to focus inquiry on decisions that significantly affect outcomes. INTESTINAL OBSTRUCTION: Graduate Health Systems, a multisite integrated provider in the Philadelphia area, has used CADU/CIS to improve quality problems, reduce treatment-intensity variations, and improve clinical participation in care process evaluation and decision making. A task force selected intestinal obstruction without hernia as its first study because of the related high-volume and high-morbidity complications. Use of a ten-step method for clinical performance improvement showed that the intravenous administration of unnecessary fluids to 104 patients with intestinal obstruction induced congestive heart failure (CHF) in 5 patients. Task force members and other practicing physicians are now developing guidelines and other interventions aimed at fluid use. Indeed, the task force used CADU/CIS to identify an additional 250 patients in one year whose conditions were complicated by CHF. A clinical decision support tool can be instrumental in detecting problems with important clinical and economic implications, identifying their important underlying causes, tracking the associated tests and therapies, and monitoring interventions.

Does clinical equipoise apply to cluster randomized trials in health research?

PubMed Central

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial

PREVALENCE OF INDUSTRY SUPPORT AND ITS RELATIONSHIP TO RESEARCH INTEGRITY

PubMed Central

Tereskerz, Patricia M.; Hamric, Ann B.; Guterbock, Thomas M.; Moreno, Jonathan D.

2009-01-01

Most U.S. clinical trials are funded by industry. Opportunities exist for sponsors to influence research in ways that jeopardize research objectivity. The purpose of this study was to survey U.S. medical school faculty to assess financial arrangements between investigators and industry to learn about investigators’ first hand knowledge of the effects of industry sponsorship on research. Here we show first-hand knowledge that compromises occurred in: research participants’ well-being (9%), research initiatives (35%), publication of results (28%), interpretation of research data (25%), and scientific advancement (20%) because of industry support. Financial relationships with industry were prevalent and considered important to conducting respondents’ research. PMID:19353387

Interpretation of correlations in clinical research.

PubMed

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

2017-11-01

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

Academia, advocacy, and industry: a collaborative method for clinical research advancement.

PubMed

Vanzo, Rena J; Lortz, Amanda; Calhoun, Amy R U L; Carey, John C

2014-07-01

Professionals who work in academia, advocacy, and industry often carry out mutually exclusive activities related to research and clinical care. However, there are several examples of collaboration among such professionals that ultimately allows for improved scientific and clinical understanding. This commentary recounts our particular experience (a collaboration between geneticists at the Universities of Minnesota and Utah, the 4p- Support Group, and Lineagen, Inc) and reviews other similar projects. We formally propose this collaborative method as a conduit for future clinical research programs. Specifically, we encourage academicians, directors of family/advocacy/support groups, and members of industry to establish partnerships and document their experiences. The medical community as a whole will benefit from such partnerships and, specifically, families will teach us lessons that could never be learned in a laboratory or textbook. © 2014 Wiley Periodicals, Inc.

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

PubMed

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

Scalable Clinical Decision Support for Individualized Cancer Risk Management | Informatics Technology for Cancer Research (ITCR)

Cancer.gov

We will build a scalable clinical decision support (CDS) platform that helps clinicians and patients select cancer screening strategies that are best suited to each individual. This kind of CDS is important because increased evidence supports personalizing cancer screening decisions according to each individual's unique cancer risks. While a highly desired goal, individualizing screening at a population scale requires the implementation of patient-specific risk assessments for several types of cancer. This is quite challenging in today's overwhelmed primary care environment.

Evaluation of Clinical Research Training Programs Using the Clinical Research Appraisal Inventory

PubMed Central

Lipira, Lauren; Jeffe, Donna B.; Krauss, Melissa; Garbutt, Jane; Piccirillo, Jay; Evanoff, Bradley; Fraser, Victoria

2010-01-01

Abstract The purpose of this study was to measure change in clinical research self‐efficacy after participating in KL2, postdoctoral and predoctoral clinical research training programs at Washington University School of Medicine. We surveyed program participants using a 76‐item version of the Clinical Research Appraisal Inventory (CRAI). Principal components analysis (PCA) examined the CRAI’s underlying factor structure; Cronbach alpha measured the internal consistency of items on each subscale and the overall CRAI. CRAI score changes from baseline to 1‐year follow‐up were assessed using repeated‐measures analysis of variance. All 29 KL2, 47 postdoctoral, and 31 TL1 scholars enrolled 2006–2009 (mean age 31.6 years, range 22–44; 59.6% female; 65.4% white) completed baseline surveys. Of these participants, 22 KL2, 17 postdoctoral, and 21 TL1 scholars completed the 1‐year follow‐up assessment. PCA resulted in a seven‐factor solution with 69 items (alphas > 0.849 for each subscale and 69‐item CRAI). Significant improvements at 1‐year follow‐up were observed across all programs for Study Design/Data Analysis (p= .016), Interpreting/Reporting/Presenting (p= .034), and overall CRAI (p= .050). Differences between programs were observed for all but one subscale (each p < .05). Clinical research self‐efficacy increased 1 year after clinical research training. Whether this short‐term outcome correlates with long‐term clinical research productivity, requires further study. Clin Trans Sci 2010; Volume 3: 243–248. PMID:21442017

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

PubMed

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

2003-08-01

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

Competency-Based Assessment for Clinical Supervisors: Design-Based Research on a Web-Delivered Program

PubMed Central

Williams, Lauren Therese; Grealish, Laurie; Jamieson, Maggie

2015-01-01

Background Clinicians need to be supported by universities to use credible and defensible assessment practices during student placements. Web-based delivery of clinical education in student assessment offers professional development regardless of the geographical location of placement sites. Objective This paper explores the potential for a video-based constructivist Web-based program to support site supervisors in their assessments of student dietitians during clinical placements. Methods This project was undertaken as design-based research in two stages. Stage 1 describes the research consultation, development of the prototype, and formative feedback. In Stage 2, the program was pilot-tested and evaluated by a purposeful sample of nine clinical supervisors. Data generated as a result of user participation during the pilot test is reported. Users’ experiences with the program were also explored via interviews (six in a focus group and three individually). The interviews were transcribed verbatim and thematic analysis conducted from a pedagogical perspective using van Manen’s highlighting approach. Results This research succeeded in developing a Web-based program, “Feed our Future”, that increased supervisors’ confidence with their competency-based assessments of students on clinical placements. Three pedagogical themes emerged: constructivist design supports transformative Web-based learning; videos make abstract concepts tangible; and accessibility, usability, and pedagogy are interdependent. Conclusions Web-based programs, such as Feed our Future, offer a viable means for universities to support clinical supervisors in their assessment practices during clinical placements. A design-based research approach offers a practical process for such Web-based tool development, highlighting pedagogical barriers for planning purposes. PMID:25803172

Computerized clinical decision support systems for chronic disease management: a decision-maker-researcher partnership systematic review.

PubMed

Roshanov, Pavel S; Misra, Shikha; Gerstein, Hertzel C; Garg, Amit X; Sebaldt, Rolf J; Mackay, Jean A; Weise-Kelly, Lorraine; Navarro, Tamara; Wilczynski, Nancy L; Haynes, R Brian

2011-08-03

The use of computerized clinical decision support systems (CCDSSs) may improve chronic disease management, which requires recurrent visits to multiple health professionals, ongoing disease and treatment monitoring, and patient behavior modification. The objective of this review was to determine if CCDSSs improve the processes of chronic care (such as diagnosis, treatment, and monitoring of disease) and associated patient outcomes (such as effects on biomarkers and clinical exacerbations). We conducted a decision-maker-researcher partnership systematic review. We searched MEDLINE, EMBASE, Ovid's EBM Reviews database, Inspec, and reference lists for potentially eligible articles published up to January 2010. We included randomized controlled trials that compared the use of CCDSSs to usual practice or non-CCDSS controls. Trials were eligible if at least one component of the CCDSS was designed to support chronic disease management. We considered studies 'positive' if they showed a statistically significant improvement in at least 50% of relevant outcomes. Of 55 included trials, 87% (n = 48) measured system impact on the process of care and 52% (n = 25) of those demonstrated statistically significant improvements. Sixty-five percent (36/55) of trials measured impact on, typically, non-major (surrogate) patient outcomes, and 31% (n = 11) of those demonstrated benefits. Factors of interest to decision makers, such as cost, user satisfaction, system interface and feature sets, unique design and deployment characteristics, and effects on user workflow were rarely investigated or reported. A small majority (just over half) of CCDSSs improved care processes in chronic disease management and some improved patient health. Policy makers, healthcare administrators, and practitioners should be aware that the evidence of CCDSS effectiveness is limited, especially with respect to the small number and size of studies measuring patient outcomes.

Computerized clinical decision support systems for chronic disease management: A decision-maker-researcher partnership systematic review

PubMed Central

2011-01-01

Background The use of computerized clinical decision support systems (CCDSSs) may improve chronic disease management, which requires recurrent visits to multiple health professionals, ongoing disease and treatment monitoring, and patient behavior modification. The objective of this review was to determine if CCDSSs improve the processes of chronic care (such as diagnosis, treatment, and monitoring of disease) and associated patient outcomes (such as effects on biomarkers and clinical exacerbations). Methods We conducted a decision-maker-researcher partnership systematic review. We searched MEDLINE, EMBASE, Ovid's EBM Reviews database, Inspec, and reference lists for potentially eligible articles published up to January 2010. We included randomized controlled trials that compared the use of CCDSSs to usual practice or non-CCDSS controls. Trials were eligible if at least one component of the CCDSS was designed to support chronic disease management. We considered studies 'positive' if they showed a statistically significant improvement in at least 50% of relevant outcomes. Results Of 55 included trials, 87% (n = 48) measured system impact on the process of care and 52% (n = 25) of those demonstrated statistically significant improvements. Sixty-five percent (36/55) of trials measured impact on, typically, non-major (surrogate) patient outcomes, and 31% (n = 11) of those demonstrated benefits. Factors of interest to decision makers, such as cost, user satisfaction, system interface and feature sets, unique design and deployment characteristics, and effects on user workflow were rarely investigated or reported. Conclusions A small majority (just over half) of CCDSSs improved care processes in chronic disease management and some improved patient health. Policy makers, healthcare administrators, and practitioners should be aware that the evidence of CCDSS effectiveness is limited, especially with respect to the small number and size of studies measuring patient outcomes

The clinical application of research utilization: amphotericin B.

PubMed

Reedy, A M; Shivnan, J C; Hanson, J L; Haisfield, M E; Gregory, R E

1994-05-01

To describe the first application of the research utilization process by clinical nurses using the Stetler-Marram Model of Research Utilization to the practice of amphotericin B administration; to share the findings; and to discuss issues encountered in the process and their solutions. Published articles identified through computerized literature searches, published abstracts and books, personal communication with one author, and an informal survey of other cancer centers' amphotericin B infusion practices; research articles were selected for review if studies included settings and patient populations similar to those of the authors and if they used experimental designs. Studies were reviewed for scientific merit and clinical applicability according to the Stetler-Marram model; findings were used to develop a specific nursing protocol for infusion times of amphotericin B based on clinical criteria. The Stetler-Marram model helped staff nurses decide how to apply research findings to practice, although using it was difficult and required mentorship. A research base exists for amphotericin B administration time but not for test doses or premedications to prevent or minimize side effects. Staff nurses can use the Stetler-Marram model but need resources and support from individuals, committees, and administration. A specific protocol representing a practice change was implemented and may be applicable to other settings.

In Defense of a Social Value Requirement for Clinical Research.

PubMed

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.

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

PubMed

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.

Nurses' clinical reasoning practices that support safe medication administration: An integrative review of the literature.

PubMed

Rohde, Emily; Domm, Elizabeth

2018-02-01

To review the current literature about nurses' clinical reasoning practices that support safe medication administration. The literature about medication administration frequently focuses on avoiding medication errors. Nurses' clinical reasoning used during medication administration to maintain medication safety receives less attention in the literature. As healthcare professionals, nurses work closely with patients, assessing and intervening to promote mediation safety prior to, during and after medication administration. They also provide discharge teaching about using medication safely. Nurses' clinical reasoning and practices that support medication safety are often invisible when the focus is medication errors avoidance. An integrative literature review was guided by Whittemore and Knafl's (Journal of Advanced Nursing, 5, 2005 and 546) five-stage review of the 11 articles that met review criteria. This review is modelled after Gaffney et al.'s (Journal of Clinical Nursing, 25, 2016 and 906) integrative review on medical error recovery. Health databases were accessed and systematically searched for research reporting nurses' clinical reasoning practices that supported safe medication administration. The level and quality of evidence of the included research articles were assessed using The Johns Hopkins Nursing Evidence-Based Practice Rating Scale©. Nurses have a central role in safe medication administration, including but not limited to risk awareness about the potential for medication errors. Nurses assess patients and their medication and use knowledge and clinical reasoning to administer medication safely. Results indicated nurses' use of clinical reasoning to maintain safe medication administration was inadequately articulated in 10 of 11 studies reviewed. Nurses are primarily responsible for safe medication administration. Nurses draw from their foundational knowledge of patient conditions and organisational processes and use clinical reasoning that

Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-14-2-0159 TITLE: Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies PRINCIPAL INVESTIGATOR...Annual PREPARED FOR: U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for...AND SUBTITLE Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT

A legal framework to enable sharing of Clinical Decision Support knowledge and services across institutional boundaries.

PubMed

Hongsermeier, Tonya; Maviglia, Saverio; Tsurikova, Lana; Bogaty, Dan; Rocha, Roberto A; Goldberg, Howard; Meltzer, Seth; Middleton, Blackford

2011-01-01

The goal of the CDS Consortium (CDSC) is to assess, define, demonstrate, and evaluate best practices for knowledge management and clinical decision support in healthcare information technology at scale - across multiple ambulatory care settings and Electronic Health Record technology platforms. In the course of the CDSC research effort, it became evident that a sound legal foundation was required for knowledge sharing and clinical decision support services in order to address data sharing, intellectual property, accountability, and liability concerns. This paper outlines the framework utilized for developing agreements in support of sharing, accessing, and publishing content via the CDSC Knowledge Management Portal as well as an agreement in support of deployment and consumption of CDSC developed web services in the context of a research project under IRB oversight.

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

PubMed Central

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

The physical therapy clinical research network (PTClinResNet): methods, efficacy, and benefits of a rehabilitation research network.

PubMed

Winstein, Carolee; Pate, Patricia; Ge, Tingting; Ervin, Carolyn; Baurley, James; Sullivan, Katherine J; Underwood, Samantha J; Fowler, Eileen G; Mulroy, Sara; Brown, David A; Kulig, Kornelia; Gordon, James; Azen, Stanley P

2008-11-01

This article describes the vision, methods, and implementation strategies used in building the infrastructure for PTClinResNet, a clinical research network designed to assess outcomes for health-related mobility associated with evidence-based physical therapy interventions across and within four different disability groups. Specific aims were to (1) create the infrastructure necessary to develop and sustain clinical trials research in rehabilitation, (2) generate evidence to evaluate the efficacy of resistance exercise-based physical interventions designed to improve muscle performance and movement skills, and (3) provide education and training opportunities for present and future clinician-researchers and for the rehabilitation community at-large in its support of evidence-based practice. We present the network's infrastructure, development, and several examples that highlight the benefits of a clinical research network. We suggest that the network structure is ideal for building research capacity and fostering multisite, multiinvestigator clinical research projects designed to generate evidence for the efficacy of rehabilitation interventions.

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

PubMed

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

Accelerating Translational Research by Clinically Driven Development of an Informatics Platform–A Case Study

PubMed Central

Abugessaisa, Imad; Saevarsdottir, Saedis; Tsipras, Giorgos; Lindblad, Staffan; Sandin, Charlotta; Nikamo, Pernilla; Ståhle, Mona; Malmström, Vivianne; Klareskog, Lars; Tegnér, Jesper

2014-01-01

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

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

PubMed

Abugessaisa, Imad; Saevarsdottir, Saedis; Tsipras, Giorgos; Lindblad, Staffan; Sandin, Charlotta; Nikamo, Pernilla; Ståhle, Mona; Malmström, Vivianne; Klareskog, Lars; Tegnér, Jesper

2014-01-01

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

Developing an Interactive Data Visualization Tool to Assess the Impact of Decision Support on Clinical Operations.

PubMed

Huber, Timothy C; Krishnaraj, Arun; Monaghan, Dayna; Gaskin, Cree M

2018-05-18

Due to mandates from recent legislation, clinical decision support (CDS) software is being adopted by radiology practices across the country. This software provides imaging study decision support for referring providers at the point of order entry. CDS systems produce a large volume of data, providing opportunities for research and quality improvement. In order to better visualize and analyze trends in this data, an interactive data visualization dashboard was created using a commercially available data visualization platform. Following the integration of a commercially available clinical decision support product into the electronic health record, a dashboard was created using a commercially available data visualization platform (Tableau, Seattle, WA). Data generated by the CDS were exported from the data warehouse, where they were stored, into the platform. This allowed for real-time visualization of the data generated by the decision support software. The creation of the dashboard allowed the output from the CDS platform to be more easily analyzed and facilitated hypothesis generation. Integrating data visualization tools into clinical decision support tools allows for easier data analysis and can streamline research and quality improvement efforts.

A clinical research analytics toolkit for cohort study.

PubMed

Yu, Yiqin; Zhu, Yu; Sun, Xingzhi; Tao, Ying; Zhang, Shuo; Xu, Linhao; Pan, Yue

2012-01-01

This paper presents a clinical informatics toolkit that can assist physicians to conduct cohort studies effectively and efficiently. The toolkit has three key features: 1) support of procedures defined in epidemiology, 2) recommendation of statistical methods in data analysis, and 3) automatic generation of research reports. On one hand, our system can help physicians control research quality by leveraging the integrated knowledge of epidemiology and medical statistics; on the other hand, it can improve productivity by reducing the complexities for physicians during their cohort studies.

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

PubMed

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

World Workshop on Oral Medicine VI: Utilization of Oral Medicine-specific software for support of clinical care, research, and education: current status and strategy for broader implementation.

PubMed

Brailo, Vlaho; Firriolo, Francis John; Tanaka, Takako Imai; Varoni, Elena; Sykes, Rosemary; McCullough, Michael; Hua, Hong; Sklavounou, Alexandra; Jensen, Siri Beier; Lockhart, Peter B; Mattsson, Ulf; Jontell, Mats

2015-08-01

To assess the current scope and status of Oral Medicine-specific software (OMSS) utilized to support clinical care, research, and education in Oral Medicine and to propose a strategy for broader implementation of OMSS within the global Oral Medicine community. An invitation letter explaining the objectives was sent to the global Oral Medicine community. Respondents were interviewed to obtain information about different aspects of OMSS functionality. Ten OMSS tools were identified. Four were being used for clinical care, one was being used for research, two were being used for education, and three were multipurpose. Clinical software was being utilized as databases developed to integrate of different type of clinical information. Research software was designed to facilitate multicenter research. Educational software represented interactive, case-orientated technology designed for clinical training in Oral Medicine. Easy access to patient data was the most commonly reported advantage. Difficulty of use and poor integration with other software was the most commonly reported disadvantage. The OMSS presented in this paper demonstrate how information technology (IT) can have an impact on the quality of patient care, research, and education in the field of Oral Medicine. A strategy for broader implementation of OMSS is proposed. Copyright © 2015 Elsevier Inc. All rights reserved.

Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

PubMed Central

Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

2012-01-01

Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

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

PubMed

Chalmers, James D; Crichton, Megan; Goeminne, Pieter C; Loebinger, Michael R; Haworth, Charles; Almagro, Marta; Vendrell, Montse; De Soyza, Anthony; Dhar, Raja; Morgan, Lucy; Blasi, Francesco; Aliberti, Stefano; Boyd, Jeanette; Polverino, Eva

2017-09-01

In contrast to airway diseases like chronic obstructive pulmonary disease or asthma, and rare diseases such as cystic fibrosis, there has been little research and few clinical trials in bronchiectasis. Guidelines are primarily based on expert opinion and treatment is challenging because of the heterogeneous nature of the disease. In an effort to address decades of underinvestment in bronchiectasis research, education and clinical care, the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative pan-European network to bring together bronchiectasis researchers. The European Respiratory Society officially funded EMBARC in 2013 as a Clinical Research Collaboration, providing support and infrastructure to allow the project to grow. EMBARC has now established an international bronchiectasis registry that is active in more than 30 countries both within and outside Europe. Beyond the registry, the network participates in designing and facilitating clinical trials, has set international research priorities, promotes education and has participated in producing the first international bronchiectasis guidelines. This manuscript article the development, structure and achievements of EMBARC from 2012 to 2017. To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areasTo understand some of the key features of successful disease registriesTo review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project in the past 5 yearsTo understand the key research priorities identified by EMBARC for the next 5 years.

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

PubMed Central

Crichton, Megan; Goeminne, Pieter C.; Loebinger, Michael R.; Haworth, Charles; Almagro, Marta; Vendrell, Montse; De Soyza, Anthony; Dhar, Raja ; Morgan, Lucy; Blasi, Francesco; Aliberti, Stefano; Boyd, Jeanette; Polverino, Eva

2017-01-01

In contrast to airway diseases like chronic obstructive pulmonary disease or asthma, and rare diseases such as cystic fibrosis, there has been little research and few clinical trials in bronchiectasis. Guidelines are primarily based on expert opinion and treatment is challenging because of the heterogeneous nature of the disease. In an effort to address decades of underinvestment in bronchiectasis research, education and clinical care, the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative pan-European network to bring together bronchiectasis researchers. The European Respiratory Society officially funded EMBARC in 2013 as a Clinical Research Collaboration, providing support and infrastructure to allow the project to grow. EMBARC has now established an international bronchiectasis registry that is active in more than 30 countries both within and outside Europe. Beyond the registry, the network participates in designing and facilitating clinical trials, has set international research priorities, promotes education and has participated in producing the first international bronchiectasis guidelines. This manuscript article the development, structure and achievements of EMBARC from 2012 to 2017. Educational aims To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areas To understand some of the key features of successful disease registries To review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project in the past 5 years To understand the key research priorities identified by EMBARC for the next 5 years PMID:28894479

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

PubMed

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

2016-05-01

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

An Internationally Consented Standard for Nursing Process-Clinical Decision Support Systems in Electronic Health Records.

PubMed

Müller-Staub, Maria; de Graaf-Waar, Helen; Paans, Wolter

2016-11-01

Nurses are accountable to apply the nursing process, which is key for patient care: It is a problem-solving process providing the structure for care plans and documentation. The state-of-the art nursing process is based on classifications that contain standardized concepts, and therefore, it is named Advanced Nursing Process. It contains valid assessments, nursing diagnoses, interventions, and nursing-sensitive patient outcomes. Electronic decision support systems can assist nurses to apply the Advanced Nursing Process. However, nursing decision support systems are missing, and no "gold standard" is available. The study aim is to develop a valid Nursing Process-Clinical Decision Support System Standard to guide future developments of clinical decision support systems. In a multistep approach, a Nursing Process-Clinical Decision Support System Standard with 28 criteria was developed. After pilot testing (N = 29 nurses), the criteria were reduced to 25. The Nursing Process-Clinical Decision Support System Standard was then presented to eight internationally known experts, who performed qualitative interviews according to Mayring. Fourteen categories demonstrate expert consensus on the Nursing Process-Clinical Decision Support System Standard and its content validity. All experts agreed the Advanced Nursing Process should be the centerpiece for the Nursing Process-Clinical Decision Support System and should suggest research-based, predefined nursing diagnoses and correct linkages between diagnoses, evidence-based interventions, and patient outcomes.

The Southeast Asian Influenza Clinical Research Network: development and challenges for a new multilateral research endeavor.

PubMed

Higgs, Elizabeth S; Hayden, Frederick G; Chotpitayasunondh, Tawee; Whitworth, Jimmy; Farrar, Jeremy

2008-04-01

The Southeast Asia Influenza Clinical Research Network (SEA ICRN) (www.seaclinicalresearch.org) is a recently developed multilateral, collaborative partnership that aims to advance scientific knowledge and management of human influenza through integrated clinical investigation. The partnership of hospitals and institutions in Indonesia, Thailand, United Kingdom, United States, and Viet Nam was established in late 2005 after agreement on the general principles and mission of the initiative and after securing initial financial support. The establishment of the SEA ICRN was both a response to the re-emergence of the highly pathogenic avian influenza A(H5N1) virus in Southeast Asia in late 2003 and an acknowledgment that clinical trials on emerging infectious diseases require prepared and coordinated research capacity. The objectives of the Network also include building sustainable research capacity in the region, compliance with international standards, and prompt dissemination of information and sharing of samples. The scope of research includes diagnosis, pathogenesis, treatment and prevention of human influenza due to seasonal or novel viruses. The Network has overcome numerous logistical and scientific challenges but has now successfully initiated several clinical trials. The establishment of a clinical research network is a vital part of preparedness and an important element during an initial response phase to a pandemic.

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

PubMed Central

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

Moral Stress and Job Burnout Among Frontline Staff Conducting Clinical Research on Affective and Anxiety Disorders

PubMed Central

Fried, Adam L.; Fisher, Celia B.

2016-01-01

There has been increased attention on job-related stress and burnout experienced by clinicians working with vulnerable and at-risk populations, including effects on personal mental health, therapeutic decision-making, and job effectiveness. Little is known, however, about the job-related stressors and symptoms of burnout experienced by clinical research staff working with similar populations, especially in terms of moral stress they may experience when adherence to scientific procedures appears to conflict with their personal commitment to address the clinical needs of their research participants or role as health care provider. In this national study, 125 frontline research workers conducting clinical research studies with individuals diagnosed with affective and anxiety disorders completed an online survey including measures assessing research work related moral stress, job burnout, organizational ethics climate and organizational research support. Results indicated that younger research workers, those whose research work was part of a graduate assistantship and perceptions of higher participant research risk were associated with higher levels of moral stress and job burnout. Supportive organizational climates were associated with lower levels of moral stress and job burnout. Recommendations for clinical research workers, supervisors and clinical training directors are discussed. PMID:28484305

Moral Stress and Job Burnout Among Frontline Staff Conducting Clinical Research on Affective and Anxiety Disorders.

PubMed

Fried, Adam L; Fisher, Celia B

2016-06-01

There has been increased attention on job-related stress and burnout experienced by clinicians working with vulnerable and at-risk populations, including effects on personal mental health, therapeutic decision-making, and job effectiveness. Little is known, however, about the job-related stressors and symptoms of burnout experienced by clinical research staff working with similar populations, especially in terms of moral stress they may experience when adherence to scientific procedures appears to conflict with their personal commitment to address the clinical needs of their research participants or role as health care provider. In this national study, 125 frontline research workers conducting clinical research studies with individuals diagnosed with affective and anxiety disorders completed an online survey including measures assessing research work related moral stress, job burnout, organizational ethics climate and organizational research support. Results indicated that younger research workers, those whose research work was part of a graduate assistantship and perceptions of higher participant research risk were associated with higher levels of moral stress and job burnout. Supportive organizational climates were associated with lower levels of moral stress and job burnout. Recommendations for clinical research workers, supervisors and clinical training directors are discussed.

Web-based multimedia information retrieval for clinical application research

NASA Astrophysics Data System (ADS)

Cao, Xinhua; Hoo, Kent S., Jr.; Zhang, Hong; Ching, Wan; Zhang, Ming; Wong, Stephen T. C.

2001-08-01

We described a web-based data warehousing method for retrieving and analyzing neurological multimedia information. The web-based method supports convenient access, effective search and retrieval of clinical textual and image data, and on-line analysis. To improve the flexibility and efficiency of multimedia information query and analysis, a three-tier, multimedia data warehouse for epilepsy research has been built. The data warehouse integrates clinical multimedia data related to epilepsy from disparate sources and archives them into a well-defined data model.

Electronic workflow for imaging in clinical research.

PubMed

Hedges, Rebecca A; Goodman, Danielle; Sachs, Peter B

2014-08-01

In the transition from paper to electronic workflow, the University of Colorado Health System's implementation of a new electronic health record system (EHR) forced all clinical groups to reevaluate their practices including the infrastructure surrounding clinical trials. Radiological imaging is an important piece of many clinical trials and requires a high level of consistency and standardization. With EHR implementation, paper orders were manually transcribed into the EHR, digitizing an inefficient work flow. A team of schedulers, radiologists, technologists, research personnel, and EHR analysts worked together to optimize the EHR to accommodate the needs of research imaging protocols. The transition to electronic workflow posed several problems: (1) there needed to be effective communication throughout the imaging process from scheduling to radiologist interpretation. (2) The exam ordering process needed to be automated to allow scheduling of specific research studies on specific equipment. (3) The billing process needed to be controlled to accommodate radiologists already supported by grants. (4) There needed to be functionality allowing exams to finalize automatically skipping the PACS and interpretation process. (5) There needed to be a way to alert radiologists that a specialized research interpretation was needed on a given exam. These issues were resolved through the optimization of the "visit type," allowing a high-level control of an exam at the time of scheduling. Additionally, we added columns and fields to work queues displaying grant identification numbers. The build solutions we implemented reduced the mistakes made and increased imaging quality and compliance.

Understanding clinical work practices for cross-boundary decision support in e-health.

PubMed

Tawfik, Hissam; Anya, Obinna; Nagar, Atulya K

2012-07-01

One of the major concerns of research in integrated healthcare information systems is to enable decision support among clinicians across boundaries of organizations and regional workgroups. A necessary precursor, however, is to facilitate the construction of appropriate awareness of local clinical practices, including a clinician's actual cognitive capabilities, peculiar workplace circumstances, and specific patient-centered needs based on real-world clinical contexts across work settings. In this paper, a user-centered study aimed to investigate clinical practices across three different geographical areas-the U.K., the UAE and Nigeria-is presented. The findings indicate that differences in clinical practices among clinicians are associated with differences in local work contexts across work settings, but are moderated by adherence to best practice guidelines and the need for patient-centered care. The study further reveals that an awareness especially of the ontological, stereotypical, and situated practices plays a crucial role in adapting knowledge for cross-boundary decision support. The paper then outlines a set of design guidelines for the development of enterprise information systems for e-health. Based on the guidelines, the paper proposes the conceptual design of CaDHealth, a practice-centered framework for making sense of clinical practices across work settings for effective cross-boundary e-health decision support.

Understanding facilitators and barriers to reengineering the clinical research enterprise in community-based practice settings.

PubMed

Kukafka, Rita; Allegrante, John P; Khan, Sharib; Bigger, J Thomas; Johnson, Stephen B

2013-09-01

Solutions are employed to support clinical research trial tasks in community-based practice settings. Using the IT Implementation Framework (ITIF), an integrative framework intended to guide the synthesis of theoretical perspectives for planning multi-level interventions to enhance IT use, we sought to understand the barriers and facilitators to clinical research in community-based practice settings preliminary to implementing new informatics solutions for improving clinical research infrastructure. The studies were conducted in practices within the Columbia University Clinical Trials Network. A mixed-method approach, including surveys, interviews, time-motion studies, and observations was used. The data collected, which incorporates predisposing, enabling, and reinforcing factors in IT use, were analyzed according to each phase of ITIF. Themes identified in the first phase of ITIF were 1) processes and tools to support clinical trial research and 2) clinical research peripheral to patient care processes. Not all of the problems under these themes were found to be amenable to IT solutions. Using the multi-level orientation of the ITIF, we set forth strategies beyond IT solutions that can have an impact on reengineering clinical research tasks in practice-based settings. Developing strategies to target enabling and reinforcing factors, which focus on organizational factors, and the motivation of the practice at large to use IT solutions to integrate clinical research tasks with patient care processes, is most challenging. The ITIF should be used to consider both IT and non-IT solutions concurrently for reengineering of clinical research in community-based practice settings. © 2013.

Recommendations for Planning Pilot Studies in Clinical and Translational Research

PubMed Central

Moore, Charity G.; Carter, Rickey E.; Nietert, Paul J.; Stewart, Paul W.

2011-01-01

Abstract  Advances in clinical and translation science are facilitated by building on prior knowledge gained through experimentation and observation. In the context of drug development, preclinical studies are followed by a progression of phase I through phase IV clinical trials. At each step, the study design and statistical strategies are framed around research questions that are prerequisites for the next phase. In other types of biomedical research, pilot studies are used for gathering preliminary support for the next research step. However, the phrase “pilot study” is liberally applied to projects with little or no funding, characteristic of studies with poorly developed research proposals, and usually conducted with no detailed thought of the subsequent study. In this article, we present a rigorous definition of a pilot study, offer recommendations for the design, analysis and sample size justification of pilot studies in clinical and translational research, and emphasize the important role that well‐designed pilot studies play in the advancement of science and scientific careers. Clin Trans Sci 2011; Volume 4: 332–337 PMID:22029804

Medication-related clinical decision support in computerized provider order entry systems: a review.

PubMed

Kuperman, Gilad J; Bobb, Anne; Payne, Thomas H; Avery, Anthony J; Gandhi, Tejal K; Burns, Gerard; Classen, David C; Bates, David W

2007-01-01

While medications can improve patients' health, the process of prescribing them is complex and error prone, and medication errors cause many preventable injuries. Computer provider order entry (CPOE) with clinical decision support (CDS), can improve patient safety and lower medication-related costs. To realize the medication-related benefits of CDS within CPOE, one must overcome significant challenges. Healthcare organizations implementing CPOE must understand what classes of CDS their CPOE systems can support, assure that clinical knowledge underlying their CDS systems is reasonable, and appropriately represent electronic patient data. These issues often influence to what extent an institution will succeed with its CPOE implementation and achieve its desired goals. Medication-related decision support is probably best introduced into healthcare organizations in two stages, basic and advanced. Basic decision support includes drug-allergy checking, basic dosing guidance, formulary decision support, duplicate therapy checking, and drug-drug interaction checking. Advanced decision support includes dosing support for renal insufficiency and geriatric patients, guidance for medication-related laboratory testing, drug-pregnancy checking, and drug-disease contraindication checking. In this paper, the authors outline some of the challenges associated with both basic and advanced decision support and discuss how those challenges might be addressed. The authors conclude with summary recommendations for delivering effective medication-related clinical decision support addressed to healthcare organizations, application and knowledge base vendors, policy makers, and researchers.

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

PubMed

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

2015-11-01

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

Physician participation in clinical research and trials: issues and approaches

PubMed Central

Rahman, Sayeeda; Majumder, Md Anwarul Azim; Shaban, Sami F; Rahman, Nuzhat; Ahmed, Moslehuddin; Abdulrahman, Khalid Bin; D’Souza, Urban JA

2011-01-01

The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system-or organization-related as well as research-and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and 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

[The future of clinical research: why do we need an ecological approach?].

PubMed

Liberati, Alessandro; Moja, Lorenzo P; Moschetti, Ivan

2006-11-01

In this paper we try to define the future goals of the clinical research, with particular reference to methodological and policy issues. There is an increasing tension between the real drivers of clinical research and its scientific and ethical aims. To consumers the goal is to strengthen the relevance and usefulness of clinical research. This is possible only if consumers are empowered and actively involved. For the health care systems it is mandatory to re-engineer the process, enforcing national and international legislation. This should help to fill the research-clinical practice gap and to balance the research agenda, better reflecting health priorities. Finally the scientific community should reflect on its own conflicts of interests and analyse the causes of the ethical divide between the needs and the market. Scientists too often seem to loose sight of the original cumulative nature of research and of the idea of research as a collective good. More non-commercial research is needed, integrated with the health care systems, to support a transparent, more realistic and valid information useful for patient care, scientific information.

New KRAS Antibodies Available | Office of Cancer Clinical Proteomics Research

Cancer.gov

Researchers estimate that approximately 30% of all human cancers are driven by RAS oncogenes. Mutated RAS genes are responsible for making RAS proteins that support cancer development. While anti-RAS therapies may have potential clinical benefit, researchers yet do not understand how the four RAS protein isoforms, KRAS4A, KRAS4B, HRAS, and NRAS, drive malignant phenotypes. Well-characterized and defined reagents like antibodies are central to reproducibility in biomedical research and necessary for future RAS studies.

Integrating complex business processes for knowledge-driven clinical decision support systems.

PubMed

Kamaleswaran, Rishikesan; McGregor, Carolyn

2012-01-01

This paper presents in detail the component of the Complex Business Process for Stream Processing framework that is responsible for integrating complex business processes to enable knowledge-driven Clinical Decision Support System (CDSS) recommendations. CDSSs aid the clinician in supporting the care of patients by providing accurate data analysis and evidence-based recommendations. However, the incorporation of a dynamic knowledge-management system that supports the definition and enactment of complex business processes and real-time data streams has not been researched. In this paper we discuss the process web service as an innovative method of providing contextual information to a real-time data stream processing CDSS.

[Proceedings of clinical pharmacy research with the cooperation of community and hospital pharmacist and pharmacy school].

PubMed

Hirotani, Yoshihiko

2007-11-01

The new pharmaceutical education system starts in Japan, those constructions are performed at a lot of universities aiming at the execution of a common examination and the clinical training, and the workshop for directive pharmacists have been held actively since last year. Moreover, various educational lectures, open lectures, and the training lectures for on-site pharmacist's upskilling are carried out. However, a technical training and the lecture for research approach that supports the pharmacist in a pharmaceutical clinical research are little at the chance to learn the research methods. Now, many joint researches with university initiative or a university is performed, and the institution of presentation inexperience at academic society also exists in terms of a regional element, a staff arrangement side, etc, and also when the continuation is difficult, it looks mostly. It is necessary that the teacher of pharmacy school almost arranged in the whole country support positively a clinical research by the nearby pharmacist, and also it seems that a clinical teacher's role is large in the cooperation of pharmacy school and the medical institution. Moreover, in order to elucidate the scientific basis (mechanism) of a problem suggestion in the clinical spot, basic research in a pharmacy school is also required. We always need to advance a pharmaceutical clinical research by considering the basic research by pharmacy school in medical institution, considering clinical research by medical institution in pharmacy school, while cooperating mutually. In this article, I show how to advance pharmaceutical clinical research.

Overview of clinical research design.

PubMed

Hartung, Daniel M; Touchette, Daniel

2009-02-15

Basic concepts and terminology of clinical research design are presented for new clinical investigators. Clinical research, research involving human subjects, can be described as either observational or experimental. The findings of all clinical research can be threatened by issues of bias and confounding. Biases are systematic errors in how study subjects are selected or measured, which result in false inferences. Confounding is a distortion in findings that is attributable to mixing variable effects. Uncontrolled observation research is generally more prone to bias and confounding than experimental research. Observational research includes designs such as the cohort study, case-control study, and cross-sectional study, while experimental research typically involves a randomized controlled trial (RCT). The cohort study, which includes the RCT, defines subject allocation on the basis of exposure interest (e.g., drug, disease-management program) and follows the patients to assess the outcomes. The case-control study uses the primary outcome of interest (e.g., adverse event) to define subject allocation, and different exposures are assessed in a retrospective manner. Cross-sectional research evaluates both exposure and outcome concurrently. Each of these design methods possesses different strengths and weaknesses in answering research questions, as well as underlying many study subtypes. While experimental research is the strongest method for establishing causality, it can be difficult to accomplish under many scenarios. Observational clinical research offers many design alternatives that may be appropriate if planned and executed carefully.

NIH Clinical Research Trials and You

MedlinePlus

... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Supporting research sites in resource-limited settings: Challenges in implementing IT infrastructure

PubMed Central

Whalen, Christopher; Donnell, Deborah; Tartakovsky, Michael

2014-01-01

As Information and Communication Technology infrastructure becomes more reliable, new methods of Electronic Data Capture (EDC), datamarts/Data warehouses, and mobile computing provide platforms for rapid coordination of international research projects and multisite studies. However, despite the increasing availability of internet connectivity and communication systems in remote regions of the world, there are still significant obstacles. Sites with poor infrastructure face serious challenges participating in modern clinical and basic research, particularly that relying on EDC and internet communication technologies. This report discusses our experiences in supporting research in resource-limited settings (RLS). We describe examples of the practical and ethical/regulatory challenges raised by use of these newer technologies for data collection in multisite clinical studies. PMID:24321986

Critical issues in clinical periodontal research.

PubMed

Preshaw, Philip M

2012-06-01

As periodontal researchers and clinicians, we are challenged every day to make decisions relating to the clinical management of our patients and about how best to conduct clinical periodontal research. This volume of Periodontology 2000 addresses some of the critical issues in contemporary clinical periodontics and periodontal research that are of direct relevance to clinicians, researchers, teachers and students. The 11 review articles in this volume of Periodontology 2000 focus on aspects of periodontal research methodology and clinical periodontology. In terms of research methodology, the articles aim to inform the reader on topics relating to randomized controlled trials in periodontal research, evidence-based dentistry, calibration of clinical examiners and statistics relevant to periodontal research. The clinical periodontology articles address issues relating to decisions on retaining periodontally compromised teeth or replacing them with implants, periodontal management in the patient with osteoporosis, surgical approaches for root coverage and the emerging science of advanced regenerative technologies, including the use of stem cells, for periodontal regeneration. It is hoped that these critical reviews will address many of the dilemmas that confront us on a regular basis and provide practical guidance to those engaged in both clinical periodontology and clinical periodontal research. © 2012 John Wiley & Sons A/S.

U.S. Ebola Treatment Center Clinical Laboratory Support.

PubMed

Jelden, Katelyn C; Iwen, Peter C; Herstein, Jocelyn J; Biddinger, Paul D; Kraft, Colleen S; Saiman, Lisa; Smith, Philip W; Hewlett, Angela L; Gibbs, Shawn G; Lowe, John J

2016-04-01

Fifty-five hospitals in the United States have been designated Ebola treatment centers (ETCs) by their state and local health authorities. Designated ETCs must have appropriate plans to manage a patient with confirmed Ebola virus disease (EVD) for the full duration of illness and must have these plans assessed through a CDC site visit conducted by an interdisciplinary team of subject matter experts. This study determined the clinical laboratory capabilities of these ETCs. ETCs were electronically surveyed on clinical laboratory characteristics. Survey responses were returned from 47 ETCs (85%). Forty-one (87%) of the ETCs planned to provide some laboratory support (e.g., point-of-care [POC] testing) within the room of the isolated patient. Forty-four (94%) ETCs indicated that their hospital would also provide clinical laboratory support for patient care. Twenty-two (50%) of these ETC clinical laboratories had biosafety level 3 (BSL-3) containment. Of all respondents, 34 (72%) were supported by their jurisdictional public health laboratory (PHL), all of which had available BSL-3 laboratories. Overall, 40 of 44 (91%) ETCs reported BSL-3 laboratory support via their clinical laboratory and/or PHL. This survey provided a snapshot of the laboratory support for designated U.S. ETCs. ETCs have approached high-level isolation critical care with laboratory support in close proximity to the patient room and by distributing laboratory support among laboratory resources. Experts might review safety considerations for these laboratory testing/diagnostic activities that are novel in the context of biocontainment care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

U.S. Ebola Treatment Center Clinical Laboratory Support

PubMed Central

Jelden, Katelyn C.; Iwen, Peter C.; Herstein, Jocelyn J.; Biddinger, Paul D.; Kraft, Colleen S.; Saiman, Lisa; Smith, Philip W.; Hewlett, Angela L.; Gibbs, Shawn G.

2016-01-01

Fifty-five hospitals in the United States have been designated Ebola treatment centers (ETCs) by their state and local health authorities. Designated ETCs must have appropriate plans to manage a patient with confirmed Ebola virus disease (EVD) for the full duration of illness and must have these plans assessed through a CDC site visit conducted by an interdisciplinary team of subject matter experts. This study determined the clinical laboratory capabilities of these ETCs. ETCs were electronically surveyed on clinical laboratory characteristics. Survey responses were returned from 47 ETCs (85%). Forty-one (87%) of the ETCs planned to provide some laboratory support (e.g., point-of-care [POC] testing) within the room of the isolated patient. Forty-four (94%) ETCs indicated that their hospital would also provide clinical laboratory support for patient care. Twenty-two (50%) of these ETC clinical laboratories had biosafety level 3 (BSL-3) containment. Of all respondents, 34 (72%) were supported by their jurisdictional public health laboratory (PHL), all of which had available BSL-3 laboratories. Overall, 40 of 44 (91%) ETCs reported BSL-3 laboratory support via their clinical laboratory and/or PHL. This survey provided a snapshot of the laboratory support for designated U.S. ETCs. ETCs have approached high-level isolation critical care with laboratory support in close proximity to the patient room and by distributing laboratory support among laboratory resources. Experts might review safety considerations for these laboratory testing/diagnostic activities that are novel in the context of biocontainment care. PMID:26842705

Prostate Cancer Clinical Consortium Clinical Research Site:Targeted Therapies

DTIC Science & Technology

2015-10-01

AWARD NUMBER: W81XWH-14-2-0159 TITLE: Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies PRINCIPAL INVESTIGATOR...Sep 2015 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies 5b. GRANT NUMBER... therapy resistance/sensitivity, identification of new therapeutic targets through high quality genomic analyses, providing access to the highest quality

Integrative oncology research in the Middle East: weaving traditional and complementary medicine in supportive care.

PubMed

Ben-Arye, Eran; Ali-Shtayeh, Mohammed Saleem; Nejmi, Mati; Schiff, Elad; Hassan, Esmat; Mutafoglu, Kamer; Afifi, Fatma U; Jamous, Rana Majed; Lev, Efraim; Silbermman, Michael

2012-03-01

Complementary and alternative medicine (CAM) has an important role in supportive cancer care in the Middle East and is often used in association with traditional medicine. This article provides a comprehensive review of published data on CAM research in supportive cancer care in the Middle East. A multi-disciplinary Middle-Eastern Research Group in Integrative Oncology (MERGIO) was established in six countries. Authors independently searched Medline database for articles in Arabic, Hebrew, French, and Turkish using oncology and CAM-related keywords. Articles were recorded according to the first author's affiliation with an academic or clinical institution in the Middle East. We identified 143 articles on CAM and cancer care that had been published in 12 Middle-Eastern countries. Eighty-five articles were directly related to cancer supportive care. The latter included studies on the prevalence of CAM use by patients with cancer, aspects related to of doctor-patient communication, ethics and regulation, psychosocial aspects of CAM, CAM safety and quality assurance, studies of CAM education for health care providers, and ethno-botanical studies and reviews. Twenty-eight articles referred to clinical research on supportive care, and the use of specific CAM modalities that included acupuncture, anthroposophic medicine, dietary and nutritional therapies herbal medicine, homeopathy, mind-body medicine, shiatsu, therapeutic touch, and yoga. CAM-related supportive care research is prevalent in the Middle East, a fact that may serve as a basis for future multinational-multidisciplinary research work in supportive care in oncology.

Clinical decision support systems for improving diagnostic accuracy and achieving precision medicine.

PubMed

Castaneda, Christian; Nalley, Kip; Mannion, Ciaran; Bhattacharyya, Pritish; Blake, Patrick; Pecora, Andrew; Goy, Andre; Suh, K Stephen

2015-01-01

As research laboratories and clinics collaborate to achieve precision medicine, both communities are required to understand mandated electronic health/medical record (EHR/EMR) initiatives that will be fully implemented in all clinics in the United States by 2015. Stakeholders will need to evaluate current record keeping practices and optimize and standardize methodologies to capture nearly all information in digital format. Collaborative efforts from academic and industry sectors are crucial to achieving higher efficacy in patient care while minimizing costs. Currently existing digitized data and information are present in multiple formats and are largely unstructured. In the absence of a universally accepted management system, departments and institutions continue to generate silos of information. As a result, invaluable and newly discovered knowledge is difficult to access. To accelerate biomedical research and reduce healthcare costs, clinical and bioinformatics systems must employ common data elements to create structured annotation forms enabling laboratories and clinics to capture sharable data in real time. Conversion of these datasets to knowable information should be a routine institutionalized process. New scientific knowledge and clinical discoveries can be shared via integrated knowledge environments defined by flexible data models and extensive use of standards, ontologies, vocabularies, and thesauri. In the clinical setting, aggregated knowledge must be displayed in user-friendly formats so that physicians, non-technical laboratory personnel, nurses, data/research coordinators, and end-users can enter data, access information, and understand the output. The effort to connect astronomical numbers of data points, including '-omics'-based molecular data, individual genome sequences, experimental data, patient clinical phenotypes, and follow-up data is a monumental task. Roadblocks to this vision of integration and interoperability include ethical, legal

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

PubMed Central

Scopetti, Matteo; Gatto, Vittorio

2017-01-01

The latest research achievements in the field of stem cells led in 2016 to the publication of “Guidelines for Stem Cell Research and Clinical Translation” by the International Society for Stem Cell Research (ISSCR). Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient's welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered. PMID:29090010

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

PubMed

Frati, Paola; Scopetti, Matteo; Santurro, Alessandro; Gatto, Vittorio; Fineschi, Vittorio

2017-01-01

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

caTIES: a grid based system for coding and retrieval of surgical pathology reports and tissue specimens in support of translational research.

PubMed

Crowley, Rebecca S; Castine, Melissa; Mitchell, Kevin; Chavan, Girish; McSherry, Tara; Feldman, Michael

2010-01-01

The authors report on the development of the Cancer Tissue Information Extraction System (caTIES)--an application that supports collaborative tissue banking and text mining by leveraging existing natural language processing methods and algorithms, grid communication and security frameworks, and query visualization methods. The system fills an important need for text-derived clinical data in translational research such as tissue-banking and clinical trials. The design of caTIES addresses three critical issues for informatics support of translational research: (1) federation of research data sources derived from clinical systems; (2) expressive graphical interfaces for concept-based text mining; and (3) regulatory and security model for supporting multi-center collaborative research. Implementation of the system at several Cancer Centers across the country is creating a potential network of caTIES repositories that could provide millions of de-identified clinical reports to users. The system provides an end-to-end application of medical natural language processing to support multi-institutional translational research programs.

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

PubMed

Makino, Hirofumi; Sada, Ken-Ei

2013-10-01

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

Clinical Nurse Specialist Roles in Conducting Research: Changes Over 3 Years.

PubMed

Albert, Nancy M; Rice, Karen L; Waldo, Mary J; Bena, James F; Mayo, Ann M; Morrison, Shannon L; Westlake, Cheryl; Ellstrom, Kathleen; Powers, Jan; Foster, Jan

2016-01-01

The aim of this study is to describe clinical nurse specialists' characteristics, interest, confidence, motivators, and barriers in conducting research. This study was a descriptive, multicohort design. Clinical nurse specialists were recruited electronically through national and local organizations to complete anonymous surveys 3 times, over 3 years. Comparative analyses included χ and Kruskal-Wallis tests. Of 2052 responders (initial, n = 629; 18 months, n = 465; and 3 years, n = 958), mean (SD) participant age was 50.3 (9.3) years. Overall, 41.7% of participants were involved as principal or coinvestigators in research. Interest in conducting nursing research (on a 0-100 scale) was 61.1 (38.4) and was lowest among the 18-month time point participant group (score, 39.1 [32.2]) and highest at the 3-year time point (68.3, [30.7]; P < .001). Confidence in conducting research, discussion of statistics, and perceptions of motivators and barriers to conducting research did not differ across time period groups. Access to literature and mentors and research knowledge were the most prevalent barriers to conducting research. Less than 42% of clinical nurse specialists conducted research and the rate did not change between different time groups. Access and knowledge barriers to conducting research were prominent. Workplace leaders need to consider resources and support of academic educational opportunities to increase research conduct by clinical nurse specialists.

Improving clinical and translational research training: a qualitative evaluation of the Atlanta Clinical and Translational Science Institute KL2-mentored research scholars program

PubMed Central

Comeau, Dawn L; Escoffery, Cam; Freedman, Ariela; Ziegler, Thomas R; Blumberg, Henry M

2017-01-01

A major impediment to improving the health of communities is the lack of qualified clinical and translational research (CTR) investigators. To address this workforce shortage, the National Institutes of Health (NIH) developed mechanisms to enhance the career development of CTR physician, PhD, and other doctoral junior faculty scientists including the CTR-focused K12 program and, subsequently, the KL2-mentored CTR career development program supported through the Clinical and Translational Science Awards (CTSAs). Our evaluation explores the impact of the K12/KL2 program embedded within the Atlanta Clinical and Translational Science Institute (ACTSI), a consortium linking Emory University, Morehouse School of Medicine and the Georgia Institute of Technology. We conducted qualitative interviews with program participants to evaluate the impact of the program on career development and collected data on traditional metrics (number of grants, publications). 46 combined K12/KL2 scholars were supported between 2002 and 2016. 30 (65%) of the 46 K12/KL2 scholars are women; 24 (52%) of the trainees are minorities, including 10 (22%) scholars who are members of an underrepresented minority group. Scholars reported increased research skills, strong mentorship experiences, and positive impact on their career trajectory. Among the 43 scholars who have completed the program, 39 (91%) remain engaged in CTR and received over $89 000 000 as principal investigators on federally funded awards. The K12/KL2 funding provided the training and protected time for successful career development of CTR scientists. These data highlight the need for continued support for CTR training programs for junior faculty. PMID:27591319

Clinical Decision Support Knowledge Management: Strategies for Success.

PubMed

Khalifa, Mohamed; Alswailem, Osama

2015-01-01

Clinical Decision Support Systems have been shown to increase quality of care, patient safety, improve adherence to guidelines for prevention and treatment, and avoid medication errors. Such systems depend mainly on two types of content; the clinical information related to patients and the medical knowledge related to the specialty that informs the system rules and alerts. At King Faisal Specialist Hospital and Research Center, Saudi Arabia, the Health Information Technology Affairs worked on identifying best strategies and recommendations for successful CDSS knowledge management. A review of literature was conducted to identify main areas of challenges and factors of success. A qualitative survey was used over six months' duration to collect opinions, experiences and suggestions from both IT and healthcare professionals. Recommendations were categorized into ten main topics that should be addressed during the development and implementation of CDSS knowledge management tools in the hospital.

Public support for medical research in the 21st century.

PubMed

Smith, P M

2000-01-01

Key public policies that have contributed to the rise of modern medical research in the 20th Century are reviewed, focusing especially on the United States and the post-World War II period. Drawing on this history, the question is posed: "Are these policies sufficient to insure vigorous medical research in the 21st Century?" Although radical policy changes are not needed, several proposals for policy and medical research portfolio redirection are offered, including a rebalancing of public supported research in all fields of science that contribute to medical advances. Medical research must also invest in a national and international information infrastructure that will allow the linking of researchers, clinical experimenters, practicing physicians, and the public in ways heretofore not imagined. Medical researchers must be leaders and advocates for the whole research enterprise in the 21st Century.

Personalizing Drug Selection Using Advanced Clinical Decision Support

PubMed Central

Pestian, John; Spencer, Malik; Matykiewicz, Pawel; Zhang, Kejian; Vinks, Alexander A.; Glauser, Tracy

2009-01-01

This article describes the process of developing an advanced pharmacogenetics clinical decision support at one of the United States’ leading pediatric academic medical centers. This system, called CHRISTINE, combines clinical and genetic data to identify the optimal drug therapy when treating patients with epilepsy or Attention Deficit Hyperactivity Disorder. In the discussion a description of clinical decision support systems is provided, along with an overview of neurocognitive computing and how it is applied in this setting. PMID:19898682

Recruiting post-doctoral fellows into global health research: selecting NIH Fogarty International Clinical Research Fellows.

PubMed

Heimburger, Douglas C; Warner, Tokesha L; Carothers, Catherine Lem; Blevins, Meridith; Thomas, Yolanda; Gardner, Pierce; Primack, Aron; Vermund, Sten H

2014-08-01

From 2008 to 2012, the National Institutes of Health (NIH) Fogarty International Clinical Research Fellows Program (FICRF) provided 1-year mentored research training at low- and middle-income country sites for American and international post-doctoral health professionals. We examined the FICRF applicant pool, proposed research topics, selection process, and characteristics of enrollees to assess trends in global health research interest and factors associated with applicant competitiveness. The majority (58%) of 67 US and 57 international Fellows were women, and 83% of Fellows had medical degrees. Most applicants were in clinical fellowships (41%) or residencies (24%). More applicants proposing infectious disease projects were supported (59%) than applicants proposing non-communicable disease (NCD) projects (41%), although projects that combined both topic areas were most successful (69%). The numbers of applicants proposing research on NCDs and the numbers of these applicants awarded fellowships rose dramatically over time. Funding provided to the FICRF varied significantly among NIH Institutes and Centers and was strongly associated with the research topics awarded. © The American Society of Tropical Medicine and Hygiene.

Should medical research have a place in future clinical training?

PubMed

Bass, Nicholas J; Vos, Adrian; Woodgate, Sarah

2007-09-01

To determine the attitudes of training grade (Senior House Officer - SHO, Specialist Registrar - SpR) and non-training grade doctors (both Staff Grade and senior or Consultant level) towards the place of research in the curriculum for junior doctors and also the pursuit of research by senior (but non-academic) clinicians. A survey of a range of doctors from differing grades (above) was sent to all doctors of the employing Trust (comprising most of the regional training scheme) with a number of fixed questions but also an opportunity to provide free-text responses. Percentages of the fixed responses were estimated and free-text responses were grouped into main themes and miscellaneous items. Despite much criticism of the current protected research time for higher trainees in psychiatry in the UK and the anticipated abolition of this within the new training structure after August 2007, we found surprising and strong support for structured research training, experience and the opportunity to pursue this at senior level even for non-academic clinical consultants. Urgent review of the new training grade curriculum is needed with emphasis on how to address the research opportunities for trainees and seniors without compromising clinical, teaching and managerial obligations. A better use of such opportunities was strongly supported rather than the proposed abolition, which seems to be fast approaching.

Research Support: The New Mission for Libraries

ERIC Educational Resources Information Center

Mitchell, Erik T.

2013-01-01

Research support services are growing areas of importance in academic libraries and are part of the libraries' larger goal to provide wider support for research-related services. Ithaka's "Library Survey 2010" indicated that research support services, along with teaching facilitation, are the two growth areas projected by library directors. In…

Tasks of research in forensic medicine - different study types in clinical research and forensic medicine.

PubMed

Madea, Burkhard; Saukko, Pekka; Musshoff, Frank

2007-01-17

In the last years the research output of forensic medicine has sometimes been regarded as insufficient and as of poor quality, especially when parameters as impact factors and external funding were taken into account. However, forensic medicine has different tasks compared to clinical medicine. The main difference between basic subjects, clinical and forensic medicine is not a lack of scientific efficiency in forensic medicine but is a result of the questions asked, the available methods and specific aims. In contrast to natural-scientific research, forensic science has furthermore important intersections with arts and socio-scientific disciplines. Etiologic and pathogenetic research is of only limited relevance in forensic medicine. Thus, forensic medicine is excluded from these research fields, which are mainly supported by external funding. In forensic medicine research mainly means applied research regarding findings, the probative value and reconstruction as well as examination at different points of intersection between medicine and law. Clinical types of research such as controlled randomised, prospective cross-sectional, cohort or case-control studies can only rarely be applied in forensic medicine due to the area specific research fields (e.g. thantatology, violent death, vitality, traffic medicine, analytical toxicology, hemogenetics and stain analysis). The types of studies which are successfully established in forensic medicine are comparison of methods, sensitivity studies, validation of methods, kinetic examinations etc. Tasks of research in forensic medicine and study types, which may be applied will be addressed.

Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review.

PubMed

Rasoal, Dara; Skovdahl, Kirsti; Gifford, Mervyn; Kihlgren, Annica

2017-12-01

This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a "bottom-up" perspective might give healthcare personnel opportunities to think and reflect more than a "top-down" perspective. A "bottom-up" approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a "top-down" approach risks removing such moral responsibility.

User-centered design to improve clinical decision support in primary care.

PubMed

Brunner, Julian; Chuang, Emmeline; Goldzweig, Caroline; Cain, Cindy L; Sugar, Catherine; Yano, Elizabeth M

2017-08-01

A growing literature has demonstrated the ability of user-centered design to make clinical decision support systems more effective and easier to use. However, studies of user-centered design have rarely examined more than a handful of sites at a time, and have frequently neglected the implementation climate and organizational resources that influence clinical decision support. The inclusion of such factors was identified by a systematic review as "the most important improvement that can be made in health IT evaluations." (1) Identify the prevalence of four user-centered design practices at United States Veterans Affairs (VA) primary care clinics and assess the perceived utility of clinical decision support at those clinics; (2) Evaluate the association between those user-centered design practices and the perceived utility of clinical decision support. We analyzed clinic-level survey data collected in 2006-2007 from 170 VA primary care clinics. We examined four user-centered design practices: 1) pilot testing, 2) provider satisfaction assessment, 3) formal usability assessment, and 4) analysis of impact on performance improvement. We used a regression model to evaluate the association between user-centered design practices and the perceived utility of clinical decision support, while accounting for other important factors at those clinics, including implementation climate, available resources, and structural characteristics. We also examined associations separately at community-based clinics and at hospital-based clinics. User-centered design practices for clinical decision support varied across clinics: 74% conducted pilot testing, 62% conducted provider satisfaction assessment, 36% conducted a formal usability assessment, and 79% conducted an analysis of impact on performance improvement. Overall perceived utility of clinical decision support was high, with a mean rating of 4.17 (±.67) out of 5 on a composite measure. "Analysis of impact on performance

Exploration Clinical Decision Support System: Medical Data Architecture

NASA Technical Reports Server (NTRS)

Lindsey, Tony; Shetye, Sandeep; Shaw, Tianna (Editor)

2016-01-01

The Exploration Clinical Decision Support (ECDS) System project is intended to enhance the Exploration Medical Capability (ExMC) Element for extended duration, deep-space mission planning in HRP. A major development guideline is the Risk of "Adverse Health Outcomes & Decrements in Performance due to Limitations of In-flight Medical Conditions". ECDS attempts to mitigate that Risk by providing crew-specific health information, actionable insight, crew guidance and advice based on computational algorithmic analysis. The availability of inflight health diagnostic computational methods has been identified as an essential capability for human exploration missions. Inflight electronic health data sources are often heterogeneous, and thus may be isolated or not examined as an aggregate whole. The ECDS System objective provides both a data architecture that collects and manages disparate health data, and an active knowledge system that analyzes health evidence to deliver case-specific advice. A single, cohesive space-ready decision support capability that considers all exploration clinical measurements is not commercially available at present. Hence, this Task is a newly coordinated development effort by which ECDS and its supporting data infrastructure will demonstrate the feasibility of intelligent data mining and predictive modeling as a biomedical diagnostic support mechanism on manned exploration missions. The initial step towards ground and flight demonstrations has been the research and development of both image and clinical text-based computer-aided patient diagnosis. Human anatomical images displaying abnormal/pathological features have been annotated using controlled terminology templates, marked-up, and then stored in compliance with the AIM standard. These images have been filtered and disease characterized based on machine learning of semantic and quantitative feature vectors. The next phase will evaluate disease treatment response via quantitative linear

[Clinical everyday ethics-support in handling moral distress? : Evaluation of an ethical decision-making model for interprofessional clinical teams].

PubMed

Tanner, S; Albisser Schleger, H; Meyer-Zehnder, B; Schnurrer, V; Reiter-Theil, S; Pargger, H

2014-06-01

High-tech medicine and cost rationing provoke moral distress up to burnout syndromes. The consequences are severe, not only for those directly involved but also for the quality of patient care and the institutions. The multimodal model METAP (Modular, Ethical, Treatment, Allocation, Process) was developed as clinical everyday ethics to support the interprofessional ethical decision-making process. The distinctive feature of the model lays in education concerning ethics competence in dealing with difficult treatment decisions. METAP has been evaluated for quality testing. The research question of interest was whether METAP supports the handling of moral distress. The evaluation included 3 intensive care units and 3 geriatric units. In all, 33 single and 9 group interviews were held with 24 physicians, 44 nurses, and 9 persons from other disciplines. An additional questionnaire was completed by 122 persons (return rate 57%). Two-thirds of the interview answers and 55% of the questionnaire findings show that clinical everyday ethics supports the handling of moral distress, especially for interdisciplinary communication and collaboration and for the explanation and evaluation of treatment goals. METAP does not provide support for persons who are rarely confronted with ethical problems or have not applied the model long enough yet. To a certain degree, moral distress is unavoidable and must be addressed as an interprofessional problem. Herein, clinical everyday ethics may provide targeted support for ethical decision-making competence.

An analysis of the NIH-supported sickle cell disease research portfolio.

PubMed

Gavini, Nara; Hoots, W Keith; Mensah, George A; Hanspal, Manjit

2015-02-01

Sickle cell disease (SCD), an inherited blood disorder is due to a single amino acid substitution on the beta chain of hemoglobin, and is characterized by anemia, severe infections, acute and chronic pain, and multi-organ damage. The National Institutes of Health (NIH) is dedicated to support basic, translational and clinical science research to improve care and ultimately, to find a cure for SCD that causes such suffering. This report provides a detailed analysis of grants funded by the NIH for SCD research in Fiscal Years 2007 through 2013. During this period, the NIH supported 247 de novo grants totaling $272,210,367 that address various aspects of SCD. 83% of these funds supported research project grants investigating the following 5 scientific themes: Pathology of Sickle Red Blood Cells; Globin Gene Expression; Adhesion and Vascular Dysfunction; Neurological Complications and Organ-specific Dysfunction; and Pain Management and Intervention. The remaining 17% of total funds supported career development and training grants; Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants; large Center grants; and Conference grants. Further analysis showed that the National Heart, Lung, and Blood Institute (NHLBI) is the largest funder of SCD research within NIH with 67% of total grants, contributing 77% of total funds; followed by the National Institute for Digestive Diseases and Kidney (NIDDK) that is funding 19% of grants, contributing 13% of total funds. The remaining 14% of grants totaling 10% of the funds were supported by all other NIH Institutes/Centers (ICs) combined. In summary, the NIH is using multiple funding mechanisms to support a sickle cell disease research agenda that is intended to advance the detection, treatment, and cure of this debilitating genetic disease. Published by Elsevier Inc.

Myositis registries and biorepositories: powerful tools to advance clinical, epidemiologic and pathogenic research.

PubMed

Rider, Lisa G; Dankó, Katalin; Miller, Frederick W

2014-11-01

Clinical registries and biorepositories have proven extremely useful in many studies of diseases, especially rare diseases. Given their rarity and diversity, the idiopathic inflammatory myopathies, or myositis syndromes, have benefited from individual researchers' collections of cohorts of patients. Major efforts are being made to establish large registries and biorepositories that will allow many additional studies to be performed that were not possible before. Here, we describe the registries developed by investigators and patient support groups that are currently available for collaborative research purposes. We have identified 46 myositis research registries, including many with biorepositories, which have been developed for a wide variety of purposes and have resulted in great advances in understanding the range of phenotypes, clinical presentations, risk factors, pathogenic mechanisms, outcome assessment, therapeutic responses, and prognoses. These are now available for collaborative use to undertake additional studies. Two myositis patient registries have been developed for research, and myositis patient support groups maintain demographic registries with large numbers of patients available to be contacted for potential research participation. Investigator-initiated myositis research registries and biorepositories have proven extremely useful in understanding many aspects of these rare and diverse autoimmune diseases. These registries and biorepositories, in addition to those developed by myositis patient support groups, deserve continued support to maintain the momentum in this field as they offer major opportunities to improve understanding of the pathogenesis and treatment of these diseases in cost-effective ways.

Opportunities for Cancer-relevant Innovative Technologies with Transformative Potential | Office of Cancer Clinical Proteomics Research

Cancer.gov

The National Cancer Institute (NCI) is seeking input from the community on identifying priorities with regards to supporting innovative technology development for cancer-relevant research. While the NCI provides support for technology development through a variety of mechanisms, it is important to understand whether or not these are sufficient for catalyzing and supporting the development of tools with significant potential for advancing important fields of cancer research or clinical care.

Clinical Research Nurse | Center for Cancer Research

Cancer.gov

We are looking for a Research Nurse to join our women’s malignancies clinical team to help us manage the care of patients participating in clinical trials. Duties include, but are not limited to, collection and reporting of clinical data; reporting adverse events; filing amendments and regulatory documents; consenting, screening and collecting samples from patients and

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

PubMed Central

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

2017-01-01

Objectives 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. Setting The setting for this research was a major academic institution in Beijing, China. Participants 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. Methods 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. Results 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. Conclusion 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

Clinical data integration model. Core interoperability ontology for research using primary care data.

PubMed

Ethier, J-F; Curcin, V; Barton, A; McGilchrist, M M; Bastiaens, H; Andreasson, A; Rossiter, J; Zhao, L; Arvanitis, T N; Taweel, A; Delaney, B C; Burgun, A

2015-01-01

This article is part of the Focus Theme of METHODS of Information in Medicine on "Managing Interoperability and Complexity in Health Systems". Primary care data is the single richest source of routine health care data. However its use, both in research and clinical work, often requires data from multiple clinical sites, clinical trials databases and registries. Data integration and interoperability are therefore of utmost importance. TRANSFoRm's general approach relies on a unified interoperability framework, described in a previous paper. We developed a core ontology for an interoperability framework based on data mediation. This article presents how such an ontology, the Clinical Data Integration Model (CDIM), can be designed to support, in conjunction with appropriate terminologies, biomedical data federation within TRANSFoRm, an EU FP7 project that aims to develop the digital infrastructure for a learning healthcare system in European Primary Care. TRANSFoRm utilizes a unified structural / terminological interoperability framework, based on the local-as-view mediation paradigm. Such an approach mandates the global information model to describe the domain of interest independently of the data sources to be explored. Following a requirement analysis process, no ontology focusing on primary care research was identified and, thus we designed a realist ontology based on Basic Formal Ontology to support our framework in collaboration with various terminologies used in primary care. The resulting ontology has 549 classes and 82 object properties and is used to support data integration for TRANSFoRm's use cases. Concepts identified by researchers were successfully expressed in queries using CDIM and pertinent terminologies. As an example, we illustrate how, in TRANSFoRm, the Query Formulation Workbench can capture eligibility criteria in a computable representation, which is based on CDIM. A unified mediation approach to semantic interoperability provides a

Improving the Quality of Informed Consent in Clinical Research with Information Technology.

PubMed

Taber, Celia; Warren, Jim; Day, Karen

2016-01-01

The clinical research industry has yet to fully embrace information technology (IT) for informed consent purposes, even though it is used indispensably in our everyday lives and in other areas of clinical research and healthcare. This paper presents findings of a meta-narrative literature review to discuss the potential for IT to improve the quality of clinical research informed consent. The review reveals three main rationales for including IT in research consent. First, in the current context consent documents frequently fail to be effective decision aids for patients, and the lack of patient centricity in the process. Second, social media provides opportunities for patients to consult with a broader community during research consent to seek broader support, and potential to participate in creating a more patient centric process. Third, multimedia tools provide opportunities for improved patient education, engagement and decision making during research consent. IT offers opportunities to achieve more meaningful research consent, but more research is needed to create an evidence base, policies and economic analyses on the return on investment of using IT in the process.

[Virtual clinical diagnosis support system of degenerative stenosis of the lumbar spinal canal].

PubMed

Shevelev, I N; Konovalov, N A; Cherkashov, A M; Molodchenkov, A A; Sharamko, T G; Asiutin, D S; Nazarenko, A G

2013-01-01

The aim of the study was to develop a virtual clinical diagnostic support system of degenerative lumbar spinal stenosis on database of spine registry. Choice of criteria's for diagnostic system was made on symptom analysis of 298 patients with lumbar spinal stenosis. Also was analysed a group of patient with disc herniation's for sensitivity and specify assessment of developed diagnostic support system. Represented clinical diagnostic support system allows identifying patients with degenerative lumbar spinal stenosis on stage of patient's primary visit. System sensitivity and specify are 90 and 71% respectively. "Online" mode of diagnostic system in structure of spine registry provides maximal availability for specialists, regardless of their locations. Development of tools "medicine 2.0" is the actual direction for carrying out further researches with which carrying out the centralized baea collection by means of specialized registers helps.

A Matrix Mentoring Model That Effectively Supports Clinical and Translational Scientists and Increases Inclusion in Biomedical Research: Lessons From the University of Utah.

PubMed

Byington, Carrie L; Keenan, Heather; Phillips, John D; Childs, Rebecca; Wachs, Erin; Berzins, Mary Anne; Clark, Kim; Torres, Maria K; Abramson, Jan; Lee, Vivian; Clark, Edward B

2016-04-01

Physician-scientists and scientists in all the health professions are vital members of the U.S. biomedical workforce, but their numbers at academic health centers are declining. Mentorship has been identified as a key component in retention of faculty members at academic health centers. Effective mentoring may promote the retention of clinician-scientists in the biomedical workforce. The authors describe a holistic institutional mentoring program to support junior faculty members engaged in clinical and translational science at the University of Utah. The clinical and translational scholars (CATS) program leverages the resources of the institution, including the Center for Clinical and Translational Science, to augment departmental resources to support junior faculty investigators and uses a multilevel mentoring matrix that includes self, senior, scientific, peer, and staff mentorship. Begun in the Department of Pediatrics, the program was expanded in 2013 to include all departments in the school of medicine and the health sciences. During the two-year program, scholars learn management essentials and have leadership training designed to develop principal investigators. Of the 86 program participants since fiscal year 2008, 92% have received extramural awards, 99% remain in academic medicine, and 95% remain at the University of Utah. The CATS program has also been associated with increased inclusion of women and underrepresented minorities in the institutional research enterprise. The CATS program manifests institutional collaboration and coordination of resources, which have benefited faculty members and the institution. The model can be applied to other academic health centers to support and sustain the biomedical workforce.

Current status of integrating information technologies into the clinical research enterprise within US academic health centers: strategic value and opportunities for investment.

PubMed

Turisco, Fran; Keogh, Diane; Stubbs, Connie; Glaser, John; Crowley, William F

2005-12-01

Little information exists about the incorporation of information technologies (ITs) into clinical research processes within US academic health centers (AHCs). Therefore, we queried a group of 37 leading AHCs regarding their current status and future plans in clinical research IT. The survey specifically inquired about the presence or absence of basic infrastructure and IT support requirements; individual applications needed to support study preparation, study conduct, and its administrative support; and integration of data from basic research, clinical trials, and the clinical information systems increasingly used in health care delivery. Of the 37 AHCs, 78% responded. All strongly agreed that a "state-of-the-art" clinical research IT program would be ideal today and will be essential tomorrow. Nonetheless, no AHC currently has an IT solution that even approached this ideal. No AHC reported having all of the essential management foundations (ie, a coherent vision, an overall strategy, a governance structure, and a dedicated budget) necessary to launch and sustain a truly successful implementation of a cohesive clinical research IT platform. Many had achieved breakthroughs in individual aspects of clinical research IT, for example, adverse event reporting systems or consent form templates. However, overall implementation of IT to support clinical research is uneven and insufficient. These data document a substantial gap in clinical research IT investments in leading US AHCs. Linking the clinical research IT enterprise with its clinical operations in a meaningful fashion remains a crucial strategic goal of AHCs. If they are to continue to serve as the "translational research engines" that our society expects, AHCs must recognize this gap and allocate substantial resource deployment to remedying this situation.

Supporting research sites in resource-limited settings: challenges in implementing information technology infrastructure.

PubMed

Whalen, Christopher J; Donnell, Deborah; Tartakovsky, Michael

2014-01-01

As information and communication technology infrastructure becomes more reliable, new methods of electronic data capture, data marts/data warehouses, and mobile computing provide platforms for rapid coordination of international research projects and multisite studies. However, despite the increasing availability of Internet connectivity and communication systems in remote regions of the world, there are still significant obstacles. Sites with poor infrastructure face serious challenges participating in modern clinical and basic research, particularly that relying on electronic data capture and Internet communication technologies. This report discusses our experiences in supporting research in resource-limited settings. We describe examples of the practical and ethical/regulatory challenges raised by the use of these newer technologies for data collection in multisite clinical studies.

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

PubMed

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

Clinical Decision Support in Electronic Prescribing: Recommendations and an Action Plan

PubMed Central

Teich, Jonathan M.; Osheroff, Jerome A.; Pifer, Eric A.; Sittig, Dean F.; Jenders, Robert A.

2005-01-01

Clinical decision support (CDS) in electronic prescribing (eRx) systems can improve the safety, quality, efficiency, and cost-effectiveness of care. However, at present, these potential benefits have not been fully realized. In this consensus white paper, we set forth recommendations and action plans in three critical domains: (1) advances in system capabilities, including basic and advanced sets of CDS interventions and knowledge, supporting database elements, operational features to improve usability and measure performance, and management and governance structures; (2) uniform standards, vocabularies, and centralized knowledge structures and services that could reduce rework by vendors and care providers, improve dissemination of well-constructed CDS interventions, promote generally applicable research in CDS methods, and accelerate the movement of new medical knowledge from research to practice; and (3) appropriate financial and legal incentives to promote adoption. PMID:15802474

Paediatric clinical research from the perspective of hospital pharmacists from France and Canada.

PubMed

Guérin, Aurélie; Tanguay, Cynthia; Lebel, Denis; Prot-Labarthe, Sonia; Bourdon, Olivier; Bussières, Jean-François

2014-12-01

To compare pharmacy support for paediatric research services in France and Canada and to describe the perception of pharmacists and rank the paediatric clinical research issues. This was a cross-sectional descriptive study. All paediatric hospitals from Canada and the main hospitals from France were contacted. A survey was conducted from May-September 2012. Descriptive statistics were performed. Results from 11 paediatric hospitals in Canada (11/12, 92%) and 11 (11/18, 61%) in France were obtained. There was a similar number of ongoing paediatric clinical trials per hospital in France versus Canada (38 (10-81) versus 20 (4-178)). A lower number of pharmacists per hospital was observed in France (17 (11.5-35) versus 45 (18.9-76.8)), but a similar number of pharmacists were assigned to clinical trials (1.5 (1-3) versus 1.9 (0.2-17.4)). Institutional protocols represented the majority of paediatric clinical trials in France (61% (14-100) versus 25% (0-100)). Similar pharmacy support services were offered, but the majority of French respondents also offered help for institutional protocol development (91 versus 50% P = 0.063). The main issues associated with paediatric clinical research were absence of financial interest from the pharmaceutical industry, prohibitive cost versus profit ratio, small patient cohorts and the non-availability of the appropriate drug formulations. Difficulties related to pharmaceutical compounding were identified as the main hindrance to paediatric clinical research; particular attention should be paid to these details when setting up a paediatric trial. © 2014 Royal Pharmaceutical Society.

A Difficult Journey: Reflections on Driving and Driving Cessation From a Team of Clinical Researchers.

PubMed

Liddle, Jacki; Gustafsson, Louise; Mitchell, Geoffrey; Pachana, Nancy A

2017-02-01

Recognizing the clinical importance and safety and well-being implications for the population, a multidisciplinary team has been researching older drivers and driving cessation issues for more than 15 years. Using empirical approaches, the team has explored quality of life and participation outcomes related to driving and nondriving for older people and has developed interventions to improve outcomes after driving cessation. The team members represent occupational therapists, medical practitioners, and clinical and neuropsychologists. While building the evidence base for driving- and driving cessation-related clinical practice, the researchers have also had first-hand experiences of interruptions to their own or parents' driving; involvement of older family members in road crashes; and provision of support during family members' driving assessment and cessation. This has led to reflection on their understandings and re-evaluation and refocusing of their perspectives in driving cessation research. This work will share the narratives of the authors and note their developing perspectives and foci within research as well as their clinical practice. Personal reflections have indicated the far-reaching implications for older drivers and family members of involvement in road crashes: the potential for interruptions to driving as a time for support and future planning and the conflicting and difficult roles of family members within the driving cessation process. Overall the lived, personal experience of the authors has reinforced the complex nature of driving and changes to driving status for the driver and their support team and the need for further research and support. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Ethical aspects of clinical research with minors.

PubMed

Bos, Wendy; Tromp, Krista; Tibboel, Dick; Pinxten, Wim

2013-07-01

Over the past decades, clinical research has increasingly been subjected to ethical requirements and legal regulation. The specific focus of ethical and legal frameworks on competent adults (which serve as the paradigmatic research subject), however, has created an ambivalent attitude towards pediatric clinical research. On one hand, minors are regarded as a vulnerable population that deserves additional protection against the risks and burdens involved in clinical research. On the other hand, the population of minors should not be denied (or not get timely) access to the benefits of clinical research. In this paper, we will explore the legal regulation and ethical guidance that currently governs pediatric clinical research in the European Union and discuss the future challenges in this field. In addition, we will discuss major ethical concerns in pediatric clinical research, with a focus on the acceptability of research risks and the informed consent process. In the discussion, we will address key concerns in both regulating pediatric clinical research and implementing ethical and legal requirement in the actual pediatric research conduct.

Design Recommendations for Pharmacogenomics Clinical Decision Support Systems

PubMed Central

Khelifi, Maher; Tarczy-Hornoch, Peter; Devine, Emily B.; Pratt, Wanda

2017-01-01

The use of pharmacogenomics (PGx) in clinical practice still faces challenges to fully adopt genetic information in targeting drug therapy. To incorporate genetics into clinical practice, many support the use of Pharmacogenomics Clinical Decision Support Systems (PGx-CDS) for medication prescriptions. This support was fueled by new guidelines to incorporate genetics for optimizing drug dosage and reducing adverse events. In addition, the complexity of PGx led to exploring CDS outside the paradigm of the basic CDS tools embedded in commercial electronic health records. Therefore, designing the right CDS is key to unleashing the full potential of pharmacogenomics and making it a part of clinicians’ daily workflow. In this work, we 1) identify challenges and barriers of the implementation of PGx-CDS in clinical settings, 2) develop a new design approach to CDS with functional characteristics that can improve the adoption of pharmacogenomics guidelines and thus patient safety, and 3) create design guidelines and recommendations for such PGx-CDS tools. PMID:28815136

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

PubMed

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

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

PubMed

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

Individual researcher liability for clinical research on humans.

PubMed

Miller, Ruth K

2003-01-01

Despite international guidelines and federal regulations, a recent rash of problems in clinical trials have highlighted weaknesses in the oversight process. The federal regulatory system depends on self-policing by researchers and institutions. Because the existing system is overworked, applying common law forms of liability to clinical researchers may encourage improvements in this self-regulation. While research necessarily involves uncertainties, researchers have the greatest direct control over the implementation of the research protocol and the most extensive direct contact with subjects, and must bear corresponding responsibility for acts which fall below the standard of care. This paper argues that the existing FDA patient protections should be adopted as the standards of care for researchers. It examines the possible application of negligence, negligence per se, and fraud and misrepresentation claims against researchers.

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

PubMed

Berthelsen, Connie Bøttcher; Hølge-Hazelton, Bibi

2018-04-01

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

Career pathways in research: support and management.

PubMed

Kenkre, J E; Foxcroft, D R

This article, the third in the series on career pathways, highlights support and management careers open to nurses working in the NHS and research and development, or people working for funding bodies or charitable organisations. These roles involve ensuring that the right infrastructure is in place to support research projects, and the correct decisions are made about which research projects should be supported and commissioned.

Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.

PubMed

Mello, Michelle M; Clarridge, Brian R; Studdert, David M

2005-01-01

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

How Will Big Data Improve Clinical and Basic Research in Radiation Therapy?

PubMed Central

Rosenstein, Barry S.; Capala, Jacek; Efstathiou, Jason A.; Hammerbacher, Jeff; Kerns, Sarah; Kong, Feng-Ming (Spring); Ostrer, Harry; Prior, Fred W.; Vikram, Bhadrasain; Wong, John; Xiao, Ying

2015-01-01

Historically, basic scientists and clinical researchers have transduced reality into data so that they might explain or predict the world. Because data are fundamental to their craft, these investigators have been on the front lines of the Big Data deluge in recent years. Radiotherapy data are complex and longitudinal data sets are frequently collected to track both tumor and normal tissue response to therapy. As basic, translational and clinical investigators explore with increasingly greater depth the complexity of underlying disease processes and treatment outcomes, larger sample populations are required for research studies and greater quantities of data are being generated. In addition, well-curated research and trial data are being pooled in public data repositories to support large-scale analyses. Thus, the tremendous quantity of information produced in both basic and clinical research in radiation therapy can now be considered as having entered the realm of Big Data. PMID:26797542

Using research to transform care for women veterans: advancing the research agenda and enhancing research-clinical partnerships.

PubMed

Yano, Elizabeth M; Bastian, Lori A; Bean-Mayberry, Bevanne; Eisen, Seth; Frayne, Susan; Hayes, Patricia; Klap, Ruth; Lipson, Linda; Mattocks, Kristin; McGlynn, Geraldine; Sadler, Anne; Schnurr, Paula; Washington, Donna L

2011-01-01

The purpose of this paper is to report on the outcomes of the 2010 VA Women's Health Services Research Conference, which brought together investigators interested in pursuing research on women veterans and women in the military with leaders in women's health care delivery and policy within and outside the VA, to significantly advance the state and future direction of VA women's health research and its potential impacts on practice and policy. Building on priorities assembled in the previous VA research agenda (2004) and the research conducted in the intervening six years, we used an array of approaches to foster research-clinical partnerships that integrated the state-of-the-science with the informational and strategic needs of senior policy and practice leaders. With demonstrated leadership commitment and support, broad field-based participation, strong interagency collaboration and a push to accelerate the move from observational to interventional and implementation research, the Conference provided a vital venue for establishing the foundation for a new research agenda. In this paper, we provide the historical evolution of the emergence of women veterans' health services research and an overview of the research in the intervening years since the first VA women's health research agenda. We then present the resulting VA Women's Health Research Agenda priorities and supporting activities designed to transform care for women veterans in six broad areas of study, including access to care and rural health; primary care and prevention; mental health; post deployment health; complex chronic conditions, aging and long-term care; and reproductive health. Published by Elsevier Inc.

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

PubMed Central

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

2012-01-01

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

Myositis registries and biorepositories: powerful tools to advance clinical, epidemiologic and pathogenic research

PubMed Central

Rider, Lisa G.; Dankó, Katalin; Miller, Frederick W.

2016-01-01

Purpose of review Clinical registries and biorepositories have proven extremely useful in many studies of diseases, especially rare diseases. Given their rarity and diversity, the idiopathic inflammatory myopathies, or myositis syndromes, have benefited from individual researchers’ collections of cohorts of patients. Major efforts are being made to establish large registries and biorepositories that will allow many additional studies to be performed that were not possible before. Here we describe the registries developed by investigators and patient support groups that are currently available for collaborative research purposes. Recent findings We have identified 46 myositis research registries, including many with biorepositories, which have been developed for a wide variety of purposes and have resulted in great advances in understanding the range of phenotypes, clinical presentations, risk factors, pathogenic mechanisms, outcome assessment, therapeutic responses, and prognoses. These are now available for collaborative use to undertake additional studies. Two myositis patient registries have been developed for research, and myositis patient support groups maintain demographic registries with large numbers of patients available to be contacted for potential research participation. Summary Investigator-initiated myositis research registries and biorepositories have proven extremely useful in understanding many aspects of these rare and diverse autoimmune diseases. These registries and biorepositories, in addition to those developed by myositis patient support groups, deserve continued support to maintain the momentum in this field as they offer major opportunities to improve understanding of the pathogenesis and treatment of these diseases in cost-effective ways. PMID:25225838

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

PubMed

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

2017-01-01

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

PARTAKE Survey of Public Knowledge and Perceptions of Clinical Research in India

PubMed Central

Burt, Tal; Dhillon, Savita; Sharma, Pooja; Khan, Danish; MV, Deepa; Alam, Sazid; Jain, Sarika; Alapati, Bhavana; Mittal, Sanjay; Singh, Padam

2013-01-01

Background A public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE – Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program. Objective To study public knowledge and perceptions of clinical research. Methods A 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India. Results Interviewees were 18–84 old (mean: 39.6, SD±16.6), 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware): ‘research benefits society’ (94.1%/3.5%/2.3%), ‘the government protects against unethical clinical research’ (56.7%/26.3%/16.9%), ‘research hospitals provide better care’ (67.2%/8.7%/23.9%), ‘confidentiality is adequately protected’ (54.1%/12.3%/33.5%), ‘participation in research is voluntary’ (85.3%/5.8%/8.7%); ‘participants treated like ‘guinea pigs’’ (20.7%/53.2%/26.0%), and ‘compensation for participation is adequate’ (24.7%/12.9%/62.3%). Conclusions Results suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation), and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants) and exhibits some distrust in the conduct and reporting of clinical trials

Collaborative partnership and the social value of clinical research: a qualitative secondary analysis.

PubMed

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

2017-10-25

Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research. A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders' perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al. The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for

Access to Core Facilities and Other Research Resources Provided by the Clinical and Translational Science Awards

PubMed Central

2012-01-01

Abstract  Principal investigators who received Clinical and Translational Science Awards created academic homes for biomedical research. They developed program‐supported websites to offer coordinated access to a range of core facilities and other research resources. Visitors to the 60 websites will find at least 170 generic services, which this review has categorized in the following seven areas: (1) core facilities, (2) biomedical informatics, (3) funding, (4) regulatory knowledge and support, (5) biostatistics, epidemiology, research design, and ethics, (6) participant and clinical interaction resources, and (7) community engagement. In addition, many websites facilitate access to resources with search engines, navigators, studios, project development teams, collaboration tools, communication systems, and teaching tools. Each of these websites may be accessed from a single site, http://www.CTSAcentral.org. The ability to access the research resources from 60 of the nation's academic health centers presents a novel opportunity for investigators engaged in clinical and translational research. Clin Trans Sci 2012; Volume #: 1–5 PMID:22376262

Access to core facilities and other research resources provided by the Clinical and Translational Science Awards.

PubMed

Rosenblum, Daniel

2012-02-01

Principal investigators who received Clinical and Translational Science Awards created academic homes for biomedical research. They developed program-supported websites to offer coordinated access to a range of core facilities and other research resources. Visitors to the 60 websites will find at least 170 generic services, which this review has categorized in the following seven areas: (1) core facilities, (2) biomedical informatics, (3) funding, (4) regulatory knowledge and support, (5) biostatistics, epidemiology, research design, and ethics, (6) participant and clinical interaction resources, and (7) community engagement. In addition, many websites facilitate access to resources with search engines, navigators, studios, project development teams, collaboration tools, communication systems, and teaching tools. Each of these websites may be accessed from a single site, http://www.CTSAcentral.org. The ability to access the research resources from 60 of the nation's academic health centers presents a novel opportunity for investigators engaged in clinical and translational research. © 2012 Wiley Periodicals, Inc.

[On the issues of functioning of the clinic of research institute of balneology].

PubMed

2012-01-01

The article presents the results of analysis of effectiveness of application of main resources in organizing and quality supporting of medical diagnostic care to patients in the clinic of research institute of balneology profile. The result data points out the insufficient effectiveness of application of these resources; the defects in organization and quality of curative diagnostic and rehabilitation care. They determine the priority directions of enhancement of functioning of the institution being a clinical base of research institute of balneology.

Evaluate the ability of clinical decision support systems (CDSSs) to improve clinical practice.

PubMed

Ajami, Sima; Amini, Fatemeh

2013-01-01

Prevalence of new diseases, medical science promotion and increase of referring to health care centers, provide a good situation for medical errors growth. Errors can involve medicines, surgery, diagnosis, equipment, or lab reports. Medical errors can occur anywhere in the health care system: In hospitals, clinics, surgery centers, doctors' offices, nursing homes, pharmacies, and patients' homes. According to the Institute of Medicine (IOM), 98,000 people die every year from preventable medical errors. In 2010 from all referred medical error records to Iran Legal Medicine Organization, 46/5% physician and medical team members were known as delinquent. One of new technologies that can reduce medical errors is clinical decision support systems (CDSSs). This study was unsystematic-review study. The literature was searched on evaluate the "ability of clinical decision support systems to improve clinical practice" with the help of library, books, conference proceedings, data bank, and also searches engines available at Google, Google scholar. For our searches, we employed the following keywords and their combinations: medical error, clinical decision support systems, Computer-Based Clinical Decision Support Systems, information technology, information system, health care quality, computer systems in the searching areas of title, keywords, abstract, and full text. In this study, more than 100 articles and reports were collected and 38 of them were selected based on their relevancy. The CDSSs are computer programs, designed for help to health care careers. These systems as a knowledge-based tool could help health care manager in analyze evaluation, improvement and selection of effective solutions in clinical decisions. Therefore, it has a main role in medical errors reduction. The aim of this study was to express ability of the CDSSs to improve

Medication-related clinical decision support alert overrides in inpatients.

PubMed

Nanji, Karen C; Seger, Diane L; Slight, Sarah P; Amato, Mary G; Beeler, Patrick E; Her, Qoua L; Dalleur, Olivia; Eguale, Tewodros; Wong, Adrian; Silvers, Elizabeth R; Swerdloff, Michael; Hussain, Salman T; Maniam, Nivethietha; Fiskio, Julie M; Dykes, Patricia C; Bates, David W

2018-05-01

To define the types and numbers of inpatient clinical decision support alerts, measure the frequency with which they are overridden, and describe providers' reasons for overriding them and the appropriateness of those reasons. We conducted a cross-sectional study of medication-related clinical decision support alerts over a 3-year period at a 793-bed tertiary-care teaching institution. We measured the rate of alert overrides, the rate of overrides by alert type, the reasons cited for overrides, and the appropriateness of those reasons. Overall, 73.3% of patient allergy, drug-drug interaction, and duplicate drug alerts were overridden, though the rate of overrides varied by alert type (P < .0001). About 60% of overrides were appropriate, and that proportion also varied by alert type (P < .0001). Few overrides of renal- (2.2%) or age-based (26.4%) medication substitutions were appropriate, while most duplicate drug (98%), patient allergy (96.5%), and formulary substitution (82.5%) alerts were appropriate. Despite warnings of potential significant harm, certain categories of alert overrides were inappropriate >75% of the time. The vast majority of duplicate drug, patient allergy, and formulary substitution alerts were appropriate, suggesting that these categories of alerts might be good targets for refinement to reduce alert fatigue. Almost three-quarters of alerts were overridden, and 40% of the overrides were not appropriate. Future research should optimize alert types and frequencies to increase their clinical relevance, reducing alert fatigue so that important alerts are not inappropriately overridden.

Justice in international clinical research.

PubMed

Pratt, Bridget; Loff, Bebe

2011-08-01

Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines. © 2010 Blackwell Publishing Ltd.

Role of technology in supporting quality control and treatment fidelity in a family caregiver clinical trial.

PubMed

Farran, Carol J; Etkin, Caryn D; McCann, Judith J; Paun, Olimpia; Eisenstein, Amy R; Wilbur, Joellen

2011-11-01

This article describes how a family caregiver lifestyle physical activity clinical trial uses research technology to enhance quality control and treatment fidelity. This trial uses a range of Internet, Blaise(®) Windows-based software and Echo Server technologies to support quality control issues, such as data collection, data entry, and study management advocated by the clinical trials literature, and to ensure treatment fidelity concerning intervention implementation (i.e., design, training, delivery, receipt, and enactment) as proposed by the National Institutes of Health Behavior Change Consortium. All research staff are trained to use these technologies. Strengths of this technological approach to support quality control and treatment fidelity include the comprehensive plan, involvement of all staff, and ability to maintain accurate and timely data. Limitations include the upfront time and costs for developing and testing these technological methods, and having support staff readily available to address technological issues if they occur.

Clinical research for neuropathies.

PubMed

Kaufmann, Petra

2012-05-01

The National Institutes of Health (NIH) has a long-standing commitment to neuropathy research. From 2005-2009, the NIH has committed US $115 million each year. A collaborative effort between researchers and patients can accelerate the translation of pre-clinical discoveries into better treatments for neuropathy patients. Clinical trials are needed to test these new treatments, but they can only be implemented in a timely fashion if patients with neuropathies are willing to participate. This perspective focuses on the value of having various outlets for informing both the patients and the physicians about existing clinical research opportunities and on the potential benefit of establishing patient registries to help with trial recruitment. Once data have been collected, there is a need to broadly share the data in order to inform future trials, and a first step would be to harmonize data collection by using Common Data Elements (CDEs). Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

Improvement of Clinical Skills through Pharmaceutical Education and Clinical Research.

PubMed

Ishizaki, Junko

2017-01-01

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

Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

PubMed

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.

Reducing Diagnostic Error with Computer-Based Clinical Decision Support

ERIC Educational Resources Information Center

Greenes, Robert A.

2009-01-01

Information technology approaches to delivering diagnostic clinical decision support (CDS) are the subject of the papers to follow in the proceedings. These will address the history of CDS and present day approaches (Miller), evaluation of diagnostic CDS methods (Friedman), and the role of clinical documentation in supporting diagnostic decision…

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

PubMed

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

2017-12-01

Clinical research coordinators play a pivotal role in phase I cancer clinical trials. We clarified the care coordination and practice for patients provided by clinical research coordinators in phase I cancer clinical trials in Japan and elucidated clinical research coordinators' perspective on patients' expectations and understanding of these trials. Fifteen clinical research coordinators participated in semi-structured interviews regarding clinical practices; perceptions of patients' expectations; and the challenges that occur before, during, and after phase I cancer clinical trials. Qualitative content analysis showed that most clinical research coordinators observed that patients have high expectations from the trials. Most listened to patients to confirm patients' understanding and reflected on responses to maintain hope, but to avoid excessive expectations; clinical research coordinators considered avoiding unplanned endings; and they aimed to establish good relationships between patients, medical staff, and among the professional team. Clinical research coordinators were insightful about the needs of patients and took a meticulous approach to the phase I cancer clinical trial process, allowing time to connect with patients and to coordinate the inter-professional research team. Additionally, education in advanced oncology care was valuable for comforting participants in cancer clinical trials.

Clinicians' experiences with the fragile X clinical and research consortium.

PubMed

Liu, Jessica A; Hagerman, Randi J; Miller, Robert M; Craft, Lisa T; Finucane, Brenda; Tartaglia, Nicole; Berry-Kravis, Elizabeth M; Sherman, Stephanie L; Kidd, Sharon A; Cohen, Jeffrey

2016-12-01

The objectives of the study were to assess the attitudes and experiences of clinicians involved in a consortium of clinics serving people with fragile X-associated disorders to gauge satisfaction with the consortium and its efforts to improve quality of life for patients and the community. An internet survey was sent to 26 fragile X (FX) clinic directors participating in the Fragile X Clinical and Research Consortium (FXCRC). Respondents were asked to complete 19 questions on consortium performance and outcomes relevant for their own clinic. The response rate was 84% (22/26), with two surveys providing incomplete data. Assistance with clinic establishment, opportunities for research collaborations, and access to colleagues and information were highly valued. Approximately 76% of clinicians reported improvements in patient care and 60% reported an increase in patient services. There was a 57% increase in participation in a FX-related clinical trial among clinics since joining the FXCRC (24% vs. 81%). Overall, respondents reported primarily positive experiences from participation in the FXCRC. Common suggestions for improvement included additional financial support and increased utilization of collected patient data for research purposes. Additionally, a Clinic Services Checklist was administered annually to examine changes in services offered over time. There were several important changes regarding the provision of services by clinics, often with multiple clinics changing with respect to a service. In conclusion, the FXCRC has led to the establishment and sustainment of fragile X clinics in the U.S., fostered cooperation among fragile X clinicians, and provided clinics with a platform to share recommendations and best practices to maximize quality of life for their patients and the overall fragile X community. The results from the survey and checklist also provide suggestions to strengthen the FXCRC and enhance future collaborations among FXCRC members. © 2016

PROFESSIONAL INTEGRATION AND CLINICAL RESEARCH.

ERIC Educational Resources Information Center

WARD, TED W.

THE RATIONALE OF A CLINICAL APPROACH TO RESEARCH ON TEACHER BEHAVIOR IS SET FORTH TOGETHER WITH INDICATION OF DIFFICULTIES. IN ONE CLINICAL STUDY, RECORDS OF FOCUSED OBSERVATIONS OF TEACHER BEHAVIOR WERE REVIEWED BY A SPECIALIST IN LEARNING AND A SPECIALIST IN SOCIAL PSYCHOLOGY IN RELATION TO RESEARCH FROM THESE FIELDS. TEACHER DECISIONS PROVED…

An ontologically founded architecture for information systems in clinical and epidemiological research.

PubMed

Uciteli, Alexandr; Groß, Silvia; Kireyev, Sergej; Herre, Heinrich

2011-08-09

This paper presents an ontologically founded basic architecture for information systems, which are intended to capture, represent, and maintain metadata for various domains of clinical and epidemiological research. Clinical trials exhibit an important basis for clinical research, and the accurate specification of metadata and their documentation and application in clinical and epidemiological study projects represents a significant expense in the project preparation and has a relevant impact on the value and quality of these studies.An ontological foundation of an information system provides a semantic framework for the precise specification of those entities which are presented in this system. This semantic framework should be grounded, according to our approach, on a suitable top-level ontology. Such an ontological foundation leads to a deeper understanding of the entities of the domain under consideration, and provides a common unifying semantic basis, which supports the integration of data and the interoperability between different information systems.The intended information systems will be applied to the field of clinical and epidemiological research and will provide, depending on the application context, a variety of functionalities. In the present paper, we focus on a basic architecture which might be common to all such information systems. The research, set forth in this paper, is included in a broader framework of clinical research and continues the work of the IMISE on these topics.

Visual research in clinical education.

PubMed

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

A regional interdependence model of musculoskeletal dysfunction: research, mechanisms, and clinical implications

PubMed Central

Sueki, Derrick G; Cleland, Joshua A; Wainner, Robert S

2013-01-01

The term ‘regional interdependence’ or RI has recently been introduced into the vernacular of physical therapy and rehabilitation literature as a clinical model of musculoskeletal assessment and intervention. The underlying premise of this model is that seemingly unrelated impairments in remote anatomical regions of the body may contribute to and be associated with a patient’s primary report of symptoms. The clinical implication of this premise is that interventions directed at one region of the body will often have effects at remote and seeming unrelated areas. The formalized concept of RI is relatively new and was originally derived in an inductive manner from a variety of earlier publications and clinical observations. However, recent literature has provided additional support to the concept. The primary purpose of this article will be to further refine the operational definition for the concept of RI, examine supporting literature, discuss possible clinically relevant mechanisms, and conclude with a discussion of the implications of these findings on clinical practice and research. PMID:24421619

Collaborative translational research leading to multicenter clinical trials in Duchenne muscular dystrophy: the Cooperative International Neuromuscular Research Group (CINRG).

PubMed

Escolar, Diana M; Henricson, Erik K; Pasquali, Livia; Gorni, Ksenija; Hoffman, Eric P

2002-10-01

Progress in the development of rationally based therapies for Duchenne muscular dystrophy has been accelerated by encouraging multidisciplinary, multi-institutional collaboration between basic science and clinical investigators in the Cooperative International Research Group. We combined existing research efforts in pathophysiology by a gene expression profiling laboratory with the efforts of animal facilities capable of conducting high-throughput drug screening and toxicity testing to identify safe and effective drug compounds that target different parts of the pathophysiologic cascade in a genome-wide drug discovery approach. Simultaneously, we developed a clinical trial coordinating center and an international network of collaborating physicians and clinics where those drugs could be tested in large-scale clinical trials. We hope that by bringing together investigators at these facilities and providing the infrastructure to support their research, we can rapidly move new bench discoveries through animal model screening and into therapeutic testing in humans in a safe, timely and cost-effective setting.

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

PubMed

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

2017-09-11

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

Managing the interface between medical schools, hospitals, and clinical research.

PubMed

Gallin, J I; Smits, H L

1997-02-26

To review how academic health centers are coping with the changing environment of health care delivery with special emphasis on the impact of the changing health care system on clinical research. In response to Health and Human Services Secretary Donna Shalala's 1995 mandated review of the National Institutes of Health (NIH) Warren Grant Magnuson Clinical Center, an NIH review team visited 30 health facilities and government-owned organizations throughout the country. The review team determined what strategies are used by academic health centers to survive and thrive in the changing health care marketplace. The findings have implications for the NIH Clinical Center as well as academic health centers. Management strategies in successful academic health centers include streamlined governance structures whereby small groups of highly empowered group leaders allow institutions to move quickly and decisively; an active strategic planning process; close integration of hospital and medical school management; heavy investment in information systems; and new structures for patient care delivery. Successful centers are initiating discussions with third-party payers and are implementing new initiatives, such as establishing their own managed care organizations, purchasing physician practices, or owning hospitals. Other approaches include establishing revenue-generating centers for clinical research and new relations with industry. Attention to the infrastructure required to support the training and conduct of clinical research is essential for the future vitality of medical schools.

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

PubMed

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.

Supervising and Supporting Student Nurses in Clinical Placements: The Peer Support Initiative.

ERIC Educational Resources Information Center

Aston, Liz; Molassiotis, Alexander

2003-01-01

A program in which senior nursing students (n=31) supported junior students (n=27) in clinical placements was evaluated. Peer support was considered valuable, but both groups desired more preparation for their roles. Seniors felt their teaching and mentoring skills were enhanced. Juniors reduced anxiety about placements. (Contains 26 references.)…

Clinical research of traditional Chinese medicine in big data era.

PubMed

Zhang, Junhua; Zhang, Boli

2014-09-01

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

A qualitative study on clinical research in Finland: fragmented governance and volume in the 2000s

PubMed Central

Hemminki, Elina; Veerus, Piret; Virtanen, Jorma; Lehto, Juhani

2013-01-01

Objectives Although concerns over clinical research have been expressed, the governance of clinical research has been little studied. The aim was to describe research policy, volume, funding and concerns over clinical research in Finland. Design A qualitative study and the data were collected from various sources, including documents, statistics and semistructured expert interviews. Setting Finland. Results We found no national policy for clinical research. Many actors were responsible for facilitating, directing, regulating and funding clinical research, but no actor had the main responsibility. Health professionals were the main drivers for clinical research. The role of the health ministry was small. The ministry distributed state money for clinical research in health services (EVO-money), but did not use it to direct research. Municipalities responsible for health services or national health insurance had little interest in clinical research. The Academy of Finland had had initiatives to promote clinical research, but they had not materialised in funding. Clinical research was common and internationally competitive, but its volume had declined relatively in the 2000s. Industry was an important private funder, mainly supporting drug trials made for licensing purposes. Drug trials without an outside sponsor (academic projects) declined between 2002 and 2010. The funding and its targeting and amount were no one's responsibility. Concerns over clinical research were similar as in other countries, but it had appeared late. Conclusions Our results suggest fragmented governance and funding in clinical research. The unsystematic research environment has not prevented clinical research from flourishing, but the public health relevance of the research carried out and its sustainability are unclear. PMID:23408074

Regenerative life support system research

NASA Technical Reports Server (NTRS)

1988-01-01

Sections on modeling, experimental activities during the grant period, and topics under consideration for the future are contained. The sessions contain discussions of: four concurrent modeling approaches that were being integrated near the end of the period (knowledge-based modeling support infrastructure and data base management, object-oriented steady state simulations for three concepts, steady state mass-balance engineering tradeoff studies, and object-oriented time-step, quasidynamic simulations of generic concepts); interdisciplinary research activities, beginning with a discussion of RECON lab development and use, and followed with discussions of waste processing research, algae studies and subsystem modeling, low pressure growth testing of plants, subsystem modeling of plants, control of plant growth using lighting and CO2 supply as variables, search for and development of lunar soil simulants, preliminary design parameters for a lunar base life support system, and research considerations for food processing in space; and appendix materials, including a discussion of the CELSS Conference, detailed analytical equations for mass-balance modeling, plant modeling equations, and parametric data on existing life support systems for use in modeling.

Translating Research on Myoelectric Control into Clinics-Are the Performance Assessment Methods Adequate?

PubMed

Vujaklija, Ivan; Roche, Aidan D; Hasenoehrl, Timothy; Sturma, Agnes; Amsuess, Sebastian; Farina, Dario; Aszmann, Oskar C

2017-01-01

Missing an upper limb dramatically impairs daily-life activities. Efforts in overcoming the issues arising from this disability have been made in both academia and industry, although their clinical outcome is still limited. Translation of prosthetic research into clinics has been challenging because of the difficulties in meeting the necessary requirements of the market. In this perspective article, we suggest that one relevant factor determining the relatively small clinical impact of myocontrol algorithms for upper limb prostheses is the limit of commonly used laboratory performance metrics. The laboratory conditions, in which the majority of the solutions are being evaluated, fail to sufficiently replicate real-life challenges. We qualitatively support this argument with representative data from seven transradial amputees. Their ability to control a myoelectric prosthesis was tested by measuring the accuracy of offline EMG signal classification, as a typical laboratory performance metrics, as well as by clinical scores when performing standard tests of daily living. Despite all subjects reaching relatively high classification accuracy offline, their clinical scores varied greatly and were not strongly predicted by classification accuracy. We therefore support the suggestion to test myocontrol systems using clinical tests on amputees, fully fitted with sockets and prostheses highly resembling the systems they would use in daily living, as evaluation benchmark. Agreement on this level of testing for systems developed in research laboratories would facilitate clinically relevant progresses in this field.

Depressive personality disorder: theoretical issues, clinical findings, and future research questions.

PubMed

Huprich, S K

1998-08-01

This article reviews the theoretical construct of depressive personality disorder and its related research. The history of depressive personality disorder is reviewed. It is concluded that differing theories converge on similar descriptions and mechanisms of development for the depressive personality disorder. Substantial empirical work supports the diagnostic distinctiveness of depressive personality disorder in clinical populations. Past and current assessment devices for assessing depressive personality disorder are also described along with their psychometric properties and clinical value. Suggestions are made for future research on the etiology and validity of the depressive personality disorder construct in order to facilitate deciding whether or not to include depressive personality disorder in future editions of the Diagnostic and Statistical Manual of Mental Disorders.

[Analysis on research projects for acupuncture and moxibustion supported by NSFC during the 11th 5-year-plan].

PubMed

Zhao, Chang-Long; Jing, Xiang-Hong; Li, Yu-Qing; Li, Liang; Rong, Pei-Jing; Wang, Chang-En

2012-08-01

In the present paper, the authors introduce the approved and finished research projects for acupuncture and moxibustion therapies supported by the National Natural Science Foundation of China (NSFC) during the 11th 5-year-plan. A total of 194 research projects were subsidized by NSFC from 2006 to 2010. These projects include 6 aspects: meridian-collaterals, acupoint theory, acupuncture analgesia, mechanisms underlying improvement of different clinical problems, clinical trials, and moxibustion therapy. The research on acupoints has been becoming a new hotspot in recent years. Majority of the research projects focus on the mechanism of acu-moxibustion underlying improvement of different clinical problems, while fewer projects on clinical trials. During the 11th 5-year-plan, 119 projects were completed; most of them involved meridian-collateral theory, acupoint theory, mechanism of acu-moxibustion underlying improvement of clinical problems and acupuncture manipulations. Following analysis of the finished research projects, we find that 1) many neurobiological methods and techniques are commonly used in the research on meridian-collateral theory; 2) the research on acupoint theory is changing from observing the local morphological structure to identifying characteristics of the regional activated receptors, particularly under the circumstances of visceral pathological conditions and efficacies of acupoints; 3) researches on the underlying mechanism of acu-moxibusiton for improving clinical disorders mainly focused on its cerebral protective effects against cerebral ischemia, in addition, researches about other diseases on clinical conditions have been also carried out, but the related mechanisms are far from understanding; 4) In many research projects, various new methods and techniques, such as fMRI, position emission tomography, genomics, proteomics, molecular biology, nerve stem cell, etc. were widely used; 5) Randomized controlled multi-center clinical trials are

Outcomes From the NIH Clinical Research Training Program: A Mentored Research Experience to Enhance Career Development of Clinician-Scientists.

PubMed

Ognibene, Frederick P; Gallin, John I; Baum, Bruce J; Wyatt, Richard G; Gottesman, Michael M

2016-12-01

Clinician-scientists are considered an endangered species for many reasons, including challenges with establishing and maintaining a career pipeline. Career outcomes from yearlong medical and dental students' research enrichment programs have not been well determined. Therefore, the authors assessed career and research outcome data from a cohort of participants in the National Institutes of Health (NIH) Clinical Research Training Program (CRTP). The CRTP provided a yearlong mentored clinical or translational research opportunity for 340 medical and dental students. Of these, 135 completed their training, including fellowships, from 1997 to January 2014. Data for 130 of 135 were analyzed: time conducting research, types of public funding (NIH grants), and publications from self-reported surveys that were verified via the NIH Research Portfolio Online Reporting Tools Web site and PubMed. Nearly two-thirds (84 of 130) indicated that they were conducting research, and over half of the 84 (approximately one-third of the total cohort) spent more than 25% of time conducting research. Of those 84, over 25% received grant support from the NIH, and those further in their careers published more scholarly manuscripts. Data suggest that the CRTP helped foster the careers of research-oriented medical and dental students as measured by time conducting research, successful competition for federal funding, and the publication of their research. Longer follow-up is warranted to assess the impact of these mentored research experiences. Investments in mentored research programs for health professional students are invaluable to support the dwindling pipeline of biomedical researchers and clinician-scientists.

Best practice & research in anaesthesiology issue on new approaches in clinical research ethics in clinical research.

PubMed

Schwenzer, Karen J

2011-12-01

The history of ethics in clinical research parallels the history of abuse of human beings. The Nuremberg Code, Declaration of Helsinki, and the Belmont Report laid the foundations for modern research ethics. In the United States, the OHRP and the FDA provide guidelines for the ethical conduct of research. Investigators should be familiar with regulations concerning informed consent, doing research in vulnerable populations, and protection of privacy. Copyright © 2011 Elsevier Ltd. All rights reserved.

Overcoming Practical Challenges to Conducting Clinical Research in the Inpatient Stroke Rehabilitation Setting

PubMed Central

Campbell, Grace B.; Skidmore, Elizabeth R.; Whyte, Ellen M.; Matthews, Judith T.

2015-01-01

There is a shortage of published empirical studies conducted in acute inpatient stroke rehabilitation, though such studies are greatly needed in order to shed light on the most efficacious inpatient stroke rehabilitation interventions. The inherent challenges of inpatient research may dissuade researchers from undertaking this important work. This paper describes our institution’s experience devising practical solutions to research barriers in this setting. Our efforts facilitated five simultaneous inpatient stroke rehabilitation studies, and led to several benefits, including increased effectiveness of research participant identification and enrollment, novel collaborative projects, innovative clinical care initiatives, and enhanced emotional and practical support for patients and their families. We provide recommendations based on lessons learned during our experience, and discuss benefits of this collaboration for our research participants, clinical staff, and the research team. PMID:25775955

Development of a Research Participants’ Perception Survey to Improve Clinical Research

PubMed Central

Yessis, Jennifer L.; Kost, Rhonda G.; Lee, Laura M.; Coller, Barry S.; Henderson, David K.

2012-01-01

Abstract Introduction: Clinical research participants’ perceptions regarding their experiences during research protocols provide outcome‐based insights into the effectiveness of efforts to protect rights and safety, and opportunities to enhance participants’ clinical research experiences. Use of validated surveys measuring patient‐centered outcomes is standard in hospitals, yet no instruments exist to assess outcomes of clinical research processes. Methods: We derived survey questions from data obtained from focus groups comprised of research participants and professionals. We assessed the survey for face/content validity, and privacy/confidentiality protections and fielded it to research participants at 15 centers. We conducted analyses of response rates, sample characteristics, and psychometrics, including survey and item completion and analysis, internal consistency, item internal consistency, criterion‐related validity, and item usefulness. Responses were tested for fit into existing patient‐centered dimensions of care and new clinical research dimensions using Cronbach's alpha coefficient. Results: Surveys were mailed to 18,890 individuals; 4,961 were returned (29%). Survey completion was 89% overall; completion rates exceeded 90% for 88 of 93 evaluable items. Questions fit into three dimensions of patient‐centered care and two novel clinical research dimensions (Cronbach's alpha for dimensions: 0.69–0.85). Conclusions: The validated survey offers a new method for assessing and improving outcomes of clinical research processes. Clin Trans Sci 2012; Volume 5: 452–460 PMID:23253666

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

PubMed

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.

Dissemination of research into clinical nursing literature.

PubMed

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

2010-12-01

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

Advanced Life Support Research and Technology Development

NASA Technical Reports Server (NTRS)

Kliss, Mark

2001-01-01

A videograph outlining life support research. The Human Exploration and Development of Space (HEDS) Enterprise's goals are to provide life support self-sufficiency for human beings to carry out research and exploration productively in space, to open the door for planetary exploration, and for benefits on Earth. Topics presented include the role of NASA Ames, funding, and technical monitoring. The focused research areas discussed include air regeneration, carbon dioxide removal, Mars Life Support, water recovery, Vapor Phase Catalytic Ammonia Removal (VPCAR), solid waste treatment, and Supercritical Water Oxidation (SCWC). Focus is placed on the utilization of Systems Integration, Modeling and Analysis (SIMA) and Dynamic Systems Modeling in this research.

Outcomes from the NIH Clinical Research Training Program: A Mentored Research Experience to Enhance Career Development of Clinician–Scientists

PubMed Central

Ognibene, Frederick P.; Gallin, John I.; Baum, Bruce J.; Wyatt, Richard G.; Gottesman, Michael M.

2017-01-01

Purpose Clinician-scientists are considered an endangered species for many reasons, including challenges with establishing and maintaining a career pipeline. Career outcomes from year-long medical and dental students’ research enrichment programs have not been well determined. Therefore, the authors assessed career and research outcome data from a cohort of participants in the National Institutes of Health (NIH) Clinical Research Training Program (CRTP). Method The CRTP provided a year-long mentored clinical or translational research opportunity for 340 medical and dental students. Of these, 135 completed their training, including fellowships, from 1997 to January 2014. Data for 130 of 135 were analyzed, including time conducting research, types of public funding (NIH grants), and publications from self-reported surveys that were verified via NIH RePORT and PUBMED. Results Nearly two-thirds (84 of 130) indicated that they were conducting research, and over half of the 84 (approximately one-third of the total cohort) spent more than 25% of time devoted to research. Of those 84, over 25% received grant support from the NIH, and those further in their careers published more scholarly manuscripts. Conclusions Data suggest that the CRTP helped foster the careers of research-oriented medical and dental students as measured by time conducting research, successful competition for federal funding, and the publication of their research. Longer follow-up is warranted to assess the impact of these mentored research experiences. Investments in mentored research programs for health professional students are invaluable to support the dwindling pipeline of biomedical researchers and clinician-scientists. PMID:27224296

Describing the implementation of an innovative intervention and evaluating its effectiveness in increasing research capacity of advanced clinical nurses: using the consolidated framework for implementation research.

PubMed

McKee, Gabrielle; Codd, Margaret; Dempsey, Orla; Gallagher, Paul; Comiskey, Catherine

2017-01-01

Despite advanced nursing roles having a research competency, participation in research is low. There are many barriers to participation in research and few interventions have been developed to address these. This paper aims to describe the implementation of an intervention to increase research participation in advanced clinical nursing roles and evaluate its effectiveness. The implementation of the intervention was carried out within one hospital site. The evaluation utilised a mixed methods design and a implementation science framework. All staff in advanced nursing roles were invited to take part, all those who were interested and had a project in mind could volunteer to participate in the intervention. The intervention consisted of the development of small research groups working on projects developed by the nurse participant/s and supported by an academic and a research fellow. The main evaluation was through focus groups. Output was analysed using thematic analysis. In addition, a survey questionnaire was circulated to all participants to ascertain their self-reported research skills before and after the intervention. The results of the survey were analysed using descriptive statistics. Finally an inventory of research outputs was collated. In the first year, twelve new clinical nurse-led research projects were conducted and reported in six peer reviewed papers, two non-peer reviewed papers and 20 conference presentations. The main strengths of the intervention were its promptness to complete research, to publish and to showcase clinical innovations. Main barriers identified were time, appropriate support from academics and from peers. The majority of participants had increased experience at scientific writing and data analysis. This study shows that an intervention, with minor financial resources; a top down approach; support of a hands on research fellow; peer collaboration with academics; strong clinical ownership by the clinical nurse researcher

Decision support for clinical laboratory capacity planning.

PubMed

van Merode, G G; Hasman, A; Derks, J; Goldschmidt, H M; Schoenmaker, B; Oosten, M

1995-01-01

The design of a decision support system for capacity planning in clinical laboratories is discussed. The DSS supports decisions concerning the following questions: how should the laboratory be divided into job shops (departments/sections), how should staff be assigned to workstations and how should samples be assigned to workstations for testing. The decision support system contains modules for supporting decisions at the overall laboratory level (concerning the division of the laboratory into job shops) and for supporting decisions at the job shop level (assignment of staff to workstations and sample scheduling). Experiments with these modules are described showing both the functionality and the validity.

People, organizational, and leadership factors impacting informatics support for clinical and translational research

PubMed Central

2013-01-01

Background In recent years, there have been numerous initiatives undertaken to describe critical information needs related to the collection, management, analysis, and dissemination of data in support of biomedical research (J Investig Med 54:327-333, 2006); (J Am Med Inform Assoc 16:316–327, 2009); (Physiol Genomics 39:131-140, 2009); (J Am Med Inform Assoc 18:354–357, 2011). A common theme spanning such reports has been the importance of understanding and optimizing people, organizational, and leadership factors in order to achieve the promise of efficient and timely research (J Am Med Inform Assoc 15:283–289, 2008). With the emergence of clinical and translational science (CTS) as a national priority in the United States, and the corresponding growth in the scale and scope of CTS research programs, the acuity of such information needs continues to increase (JAMA 289:1278–1287, 2003); (N Engl J Med 353:1621–1623, 2005); (Sci Transl Med 3:90, 2011). At the same time, systematic evaluations of optimal people, organizational, and leadership factors that influence the provision of data, information, and knowledge management technologies and methods are notably lacking. Methods In response to the preceding gap in knowledge, we have conducted both: 1) a structured survey of domain experts at Academic Health Centers (AHCs); and 2) a subsequent thematic analysis of public-domain documentation provided by those same organizations. The results of these approaches were then used to identify critical factors that may influence access to informatics expertise and resources relevant to the CTS domain. Results A total of 31 domain experts, spanning the Biomedical Informatics (BMI), Computer Science (CS), Information Science (IS), and Information Technology (IT) disciplines participated in a structured surveyprocess. At a high level, respondents identified notable differences in theaccess to BMI, CS, and IT expertise and services depending on the establishment of a

Using the LOINC Semantic Structure to Integrate Community-based Survey Items into a Concept-based Enterprise Data Dictionary to Support Comparative Effectiveness Research.

PubMed

Co, Manuel C; Boden-Albala, Bernadette; Quarles, Leigh; Wilcox, Adam; Bakken, Suzanne

2012-01-01

In designing informatics infrastructure to support comparative effectiveness research (CER), it is necessary to implement approaches for integrating heterogeneous data sources such as clinical data typically stored in clinical data warehouses and those that are normally stored in separate research databases. One strategy to support this integration is the use of a concept-oriented data dictionary with a set of semantic terminology models. The aim of this paper is to illustrate the use of the semantic structure of Clinical LOINC (Logical Observation Identifiers, Names, and Codes) in integrating community-based survey items into the Medical Entities Dictionary (MED) to support the integration of survey data with clinical data for CER studies.

An Opportunity to Bridge the Gap Between Clinical Research and Clinical Practice: Implications for Clinical Training

PubMed Central

Hershenberg, Rachel; Drabick, Deborah A. G.; Vivian, Dina

2013-01-01

Clinical researchers and clinical practitioners share a goal of increasing the integration of research and clinical practice, which is reflected in an evidence-based practice (EBP) approach to psychology. The EBP framework involves the integration of research findings with clinical expertise and client characteristics, values, and preferences, and consequently provides an important foundation for conducting clinically relevant research, as well as empirically based and clinically sensitive practice. Given the critical role that early training can play in the integration of science and practice and in promoting the future of the field, the present article addresses predoctoral training programs as a context for adopting an EBP approach to clinical work. We address training in the three components of EBP and provide suggestions for curriculum development and practicum training that we hope will contribute to bridging the gap between research and practice. PMID:22642520

Be a Partner in Clinical Research

MedlinePlus

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[Publication rate of Deutsche Forschungsgemeinschaft (DFG)-supported research projects. An analysis of the "fate" of DFG-support methods in anesthesia, surgery and internal medicine].

PubMed

Boldt, J; Maleck, W

2000-09-22

Outstanding medical research is not possible without financial support. The success of supported research projects have been evaluated only rarely. The publication rate of research projects supported by the German Research Council (Deutsche Forschungsgemeinschaft [DFG]) was assessed separately for internal medicine, surgery, and anesthesiology. Based on the "Figures and Facts" published by the DFG all supported projects of 1996 for all three specialities were included. In a Medline-based analysis all published papers dealing with the supported project and all papers published by the supported persons from 1996 to may 2000 were documented. A total of 315 grants were analysed (internal medicine: 234; surgery: 63; anesthesiology: 18). Projects with clinical topics were less often supported (n = 80) than experimental projects (n = 235). 162 (69.3%) of the grants in internal medicine, 41 (65.1) in surgery, and 14 (77.8%) of the grants in anesthesiology were published. In anesthesiology all published projects were in English language (internal medicine: 98.2%; surgery: 95%). Independent of the topic of the grant, several supported persons in internal medicine and surgery did not publish any papers between 1996 and may 2000, whereas all supported anesthesiologists published papers in peer reviewed journals in this time period. The publication rate of DFG supported projects is not sufficient. Except for a final internal report after finishing the research project no quality control exists for DFG grants. Unfortunately, not all supported projects were published. A better feedback between the financial support by the DFG and the publication rate of DFG grants is desirable.

The Weiland Medal: Clinical Research in Hand Surgery

PubMed Central

Chung, Kevin C.

2015-01-01

Clinical research designed to enhance the quality of healthcare has always received a great deal of national attention. Outcomes studies, clinical trials, and evidence-based research are key components of clinical research that have advanced the field of hand surgery. The purpose of the Weiland Award is to encourage innovations and progress in clinical research in hand surgery for the betterment of patients and to promote hand surgery’s visibility in American medicine. This article will highlight my efforts in clinical research through three specific research themes: (1) outcomes research, (2) economic analysis, and (3) evidence-based research and quality assessment in healthcare. PMID:20117312

New directions in hypnosis research: strategies for advancing the cognitive and clinical neuroscience of hypnosis

PubMed Central

Jensen, Mark P; Jamieson, Graham A; Lutz, Antoine; Mazzoni, Giuliana; McGeown, William J; Santarcangelo, Enrica L; Demertzi, Athena; De Pascalis, Vilfredo; Bányai, Éva I; Rominger, Christian; Vuilleumier, Patrik; Faymonville, Marie-Elisabeth; Terhune, Devin B

2017-01-01

Abstract This article summarizes key advances in hypnosis research during the past two decades, including (i) clinical research supporting the efficacy of hypnosis for managing a number of clinical symptoms and conditions, (ii) research supporting the role of various divisions in the anterior cingulate and prefrontal cortices in hypnotic responding, and (iii) an emerging finding that high hypnotic suggestibility is associated with atypical brain connectivity profiles. Key recommendations for a research agenda for the next decade include the recommendations that (i) laboratory hypnosis researchers should strongly consider how they assess hypnotic suggestibility in their studies, (ii) inclusion of study participants who score in the middle range of hypnotic suggestibility, and (iii) use of expanding research designs that more clearly delineate the roles of inductions and specific suggestions. Finally, we make two specific suggestions for helping to move the field forward including (i) the use of data sharing and (ii) redirecting resources away from contrasting state and nonstate positions toward studying (a) the efficacy of hypnotic treatments for clinical conditions influenced by central nervous system processes and (b) the neurophysiological underpinnings of hypnotic phenomena. As we learn more about the neurophysiological mechanisms underlying hypnosis and suggestion, we will strengthen our knowledge of both basic brain functions and a host of different psychological functions. PMID:29034102

Assessment of Translational and Interdisciplinary Clinical Research at an Oklahoma Health Sciences Center

PubMed Central

Dao, Hanh Dung; Kota, Pravina; James, Judith A.; Stoner, Julie A.; Akins, Darrin R.

2015-01-01

Purpose In response to National Institutes of Health initiatives to improve translation of basic science discoveries we surveyed faculty to assess patterns of and barriers to translational research in Oklahoma. Methods An online survey was administered to University of Oklahoma Health Sciences Center, College of Medicine faculty, which included demographic and research questions. Results Responses were received from 126 faculty members (24%). Two-thirds spent ≥20% time on research; among these, 90% conduct clinical and translational research. Identifying funding; recruiting research staff and participants; preparing reports and agreements; and protecting research time were commonly perceived as at least moderate barriers to conducting research. While respondents largely collaborated within their discipline, clinical investigators were more likely than basic science investigators to engage in interdisciplinary research. Conclusion While engagement in translational research is common, specific barriers impact the research process. This could be improved through an expanded interdisciplinary collaboration and research support structure. PMID:26242016

A comprehensive clinical research database based on CDISC ODM and i2b2.

PubMed

Meineke, Frank A; Stäubert, Sebastian; Löbe, Matthias; Winter, Alfred

2014-01-01

We present a working approach for a clinical research database as part of an archival information system. The CDISC ODM standard is target for clinical study and research relevant routine data, thus decoupling the data ingest process from the access layer. The presented research database is comprehensive as it covers annotating, mapping and curation of poorly annotated source data. Besides a conventional relational database the medical data warehouse i2b2 serves as main frontend for end-users. The system we developed is suitable to support patient recruitment, cohort identification and quality assurance in daily routine.

Clinical outcomes research in gynecologic oncology.

PubMed

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.

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

PubMed

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.

[Overdenture supported by natural teeth: analysis of clinical advantages].

PubMed

Scotti, R; Melilli, D; Pizzo, G

2003-05-01

Hybrid prosthesis supported by natural teeth (overdenture) is widely used in clinical practice and should be executed whenever the clinical conditions suggest it. Through a critical review of the literature, the anatomical, functional, psychological and clinical advantages are emphasized. Among the first ones, the prophylaxis of residual anatomical components, due to the limitation of bone resorption, and the preservation of sensorial proprioception are relevant. Important advantages are also represented by a better crown-root ratio of residual teeth supporting overdenture, with the consequent improvement of the longitudinal prognosis of such teeth. The greater retention and stability of overdenture in comparison with complete denture greatly improve the masticatory efficacy. The psychological advantages resulting from the dental anchorage, which allows the patient to be more confident in social life, are also relevant. Finally, when the dental support is lost, converting overdenture into complete denture is simple and quick, and makes easier the longitudinal clinical maintenance of the denture.

Beyond "utilitarianism": maximizing the clinical impact of moral judgment research.

PubMed

Rosas, Alejandro; Koenigs, Michael

2014-01-01

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

Factors Predicting Oncology Care Providers' Behavioral Intention to Adopt Clinical Decision Support Systems

ERIC Educational Resources Information Center

Wolfenden, Andrew

2012-01-01

The purpose of this quantitative correlation study was to examine the predictors of user behavioral intention on the decision of oncology care providers to adopt or reject the clinical decision support system. The Unified Theory of Acceptance and Use of Technology (UTAUT) formed the foundation of the research model and survey instrument. The…

Questioning skills of clinical facilitators supporting undergraduate nursing students.

PubMed

Phillips, Nicole M; Duke, Maxine M; Weerasuriya, Rona

2017-12-01

To report on a study investigating questioning skills of clinical facilitators who support the learning of undergraduate nursing students. The ability to think critically is integral to decision-making and the provision of safe and quality patient care. Developing students' critical thinking skills is expected of those who supervise and facilitate student learning in the clinical setting. Models used to facilitate student learning in the clinical setting have changed over the years with clinicians having dual responsibility for patient care and facilitating student learning. Many of these nurses have no preparation for the educative role. This study adapted a comparative study conducted over fifteen years ago. Descriptive online survey including three acute care patient scenarios involving an undergraduate nursing student. Participants were required to identify the questions they would ask the student in relation to the scenario. A total of 133 clinical facilitators including clinical teachers, clinical educators and preceptors from five large partner healthcare organisations of one Australian university participated. The majority of questions asked were knowledge questions, the lowest category in the cognitive domain requiring only simple recall of information. Facilitators who had undertaken an education-related course/workshop or formal qualification asked significantly more questions from the higher cognitive level. The study provides some evidence that nursing facilitators in the clinical setting ask students predominantly low-level questions. Further research is needed to identify strategies that develop the capacity of facilitators to ask higher level cognitive questions. Clinical facilitators should undertake targeted education that focuses on how to frame questions for students that demand application, analysis, synthesis and evaluation. © 2017 John Wiley & Sons Ltd.

Exploring Nurse Manager Support of Evidence-Based Practice: Clinical Nurse Perceptions.

PubMed

Caramanica, Laura; Spiva, LeeAnna

2018-05-01

The study identifies what constitutes nurse manager (NM) support and other resources that enable clinical nurses (CNs) to engage in evidence-based practice (EBP). Clinical nurses report that NM support enables them to use EBP but what constitutes NM support is still unclear. Nurse managers, CNs, and EBP mentors received specialized education and use a team approach for EBP. Data were collected preintervention, mid-intervention, and postintervention from observations, interviews, journaling, and surveys. Results demonstrate how NMs can perform their role responsibilities and still engage CNs to develop a spirit of inquiry, seek answers to their clinical questions using EBP, and advance their clinical performance to improve patient outcomes. Four NM supportive behaviors emerged: cultivating a shared EBP vision, ensuring use of EBP, communicating the value of EBP, and providing resources for EBP. Through education and support, NMs describe supportive behaviors necessary for the successful conduction of EBP by CNs.

Use of videos to support teaching and learning of clinical skills in nursing education: A review.

PubMed

Forbes, Helen; Oprescu, Florin I; Downer, Terri; Phillips, Nicole M; McTier, Lauren; Lord, Bill; Barr, Nigel; Alla, Kristel; Bright, Peter; Dayton, Jeanne; Simbag, Vilma; Visser, Irene

2016-07-01

Information and communications technology is influencing the delivery of education in tertiary institutions. In particular, the increased use of videos for teaching and learning clinical skills in nursing may be a promising direction to pursue, yet we need to better document the current research in this area of inquiry. The aim of this paper was to explore and document the current areas of research into the use of videos to support teaching and learning of clinical skills in nursing education. The four main areas of current and future research are effectiveness, efficiency, usage, and quality of videos as teaching and learning materials. While there is a clear need for additional research in the area, the use of videos seems to be a promising, relevant, and increasingly used instructional strategy that could enhance the quality of clinical skills education. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluating Various Areas of Process Improvement in an Effort to Improve Clinical Research: Discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management Workshop

PubMed Central

Cola, Philip A.; Rosenblum, Daniel

2013-01-01

Abstract Emphasis has been placed on assessing the efficiency of clinical and translational research as part of the National Institutes of Health (NIH) goal to “improve human health.” Improvements identified and implemented by individual organizations cannot address the research infrastructure needs of all clinical and translational research conducted. NIH's National Center for Advancing Translational Sciences (NCATS) has brought together 61 Clinical and Translational Science Award (CTSA) sites creating a virtual national laboratory that reflects the diversity and breadth of academic medical centers to collectively improve clinical and translational science. The annual Clinical Research Management workshop is organized by the CTSA consortium with participation from CTSA awardees, NIH, and others with an interest in clinical research management. The primary objective of the workshop is to disseminate information that improves clinical research management although the specific objectives of each workshop evolve within the consortium. The fifth annual workshop entitled “Learning by doing; applying evidence‐based tools to re‐engineer clinical research management” took place in June 2012. The primary objective of the 2012 workshop was to utilize data to evaluate, modify, and improve clinical research management. This report provides a brief summary of the workshop proceedings and the major themes discussed among the participants. PMID:23919369

Evaluating various areas of process improvement in an effort to improve clinical research: discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management workshop.

PubMed

Strasser, Jane E; Cola, Philip A; Rosenblum, Daniel

2013-08-01

Emphasis has been placed on assessing the efficiency of clinical and translational research as part of the National Institutes of Health (NIH) goal to "improve human health." Improvements identified and implemented by individual organizations cannot address the research infrastructure needs of all clinical and translational research conducted. NIH's National Center for Advancing Translational Sciences (NCATS) has brought together 61 Clinical and Translational Science Award (CTSA) sites creating a virtual national laboratory that reflects the diversity and breadth of academic medical centers to collectively improve clinical and translational science. The annual Clinical Research Management workshop is organized by the CTSA consortium with participation from CTSA awardees, NIH, and others with an interest in clinical research management. The primary objective of the workshop is to disseminate information that improves clinical research management although the specific objectives of each workshop evolve within the consortium. The fifth annual workshop entitled "Learning by doing; applying evidence-based tools to re-engineer clinical research management" took place in June 2012. The primary objective of the 2012 workshop was to utilize data to evaluate, modify, and improve clinical research management. This report provides a brief summary of the workshop proceedings and the major themes discussed among the participants. © 2013 Wiley Periodicals, Inc.

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

PubMed

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.

Preprocessing Structured Clinical Data for Predictive Modeling and Decision Support

PubMed Central

Oliveira, Mónica Duarte; Janela, Filipe; Martins, Henrique M. G.

2016-01-01

Summary Background EHR systems have high potential to improve healthcare delivery and management. Although structured EHR data generates information in machine-readable formats, their use for decision support still poses technical challenges for researchers due to the need to preprocess and convert data into a matrix format. During our research, we observed that clinical informatics literature does not provide guidance for researchers on how to build this matrix while avoiding potential pitfalls. Objectives This article aims to provide researchers a roadmap of the main technical challenges of preprocessing structured EHR data and possible strategies to overcome them. Methods Along standard data processing stages – extracting database entries, defining features, processing data, assessing feature values and integrating data elements, within an EDPAI framework –, we identified the main challenges faced by researchers and reflect on how to address those challenges based on lessons learned from our research experience and on best practices from related literature. We highlight the main potential sources of error, present strategies to approach those challenges and discuss implications of these strategies. Results Following the EDPAI framework, researchers face five key challenges: (1) gathering and integrating data, (2) identifying and handling different feature types, (3) combining features to handle redundancy and granularity, (4) addressing data missingness, and (5) handling multiple feature values. Strategies to address these challenges include: cross-checking identifiers for robust data retrieval and integration; applying clinical knowledge in identifying feature types, in addressing redundancy and granularity, and in accommodating multiple feature values; and investigating missing patterns adequately. Conclusions This article contributes to literature by providing a roadmap to inform structured EHR data preprocessing. It may advise researchers on potential

Medical Device Integrated Vital Signs Monitoring Application with Real-Time Clinical Decision Support.

PubMed

Moqeem, Aasia; Baig, Mirza; Gholamhosseini, Hamid; Mirza, Farhaan; Lindén, Maria

2018-01-01

This research involves the design and development of a novel Android smartphone application for real-time vital signs monitoring and decision support. The proposed application integrates market available, wireless and Bluetooth connected medical devices for collecting vital signs. The medical device data collected by the app includes heart rate, oxygen saturation and electrocardiograph (ECG). The collated data is streamed/displayed on the smartphone in real-time. This application was designed by adopting six screens approach (6S) mobile development framework and focused on user-centered approach and considered clinicians-as-a-user. The clinical engagement, consultations, feedback and usability of the application in the everyday practices were considered critical from the initial phase of the design and development. Furthermore, the proposed application is capable to deliver rich clinical decision support in real-time using the integrated medical device data.

Expanding Library Support of Faculty Research: Exploring Readiness

ERIC Educational Resources Information Center

Brown, Jeanne M.; Tucker, Cory

2013-01-01

The changing research and information environment requires a reexamination of library support for research. This study considers research-related attitudes and practices to identify elements indicating readiness or resistance to expanding the library's role in research support. A survey of faculty conducted at the University of Nevada Las Vegas…

Nurturing educational research at Dartmouth Medical School: the synergy among innovative ideas, support faculty, and administrative structures.

PubMed

Nierenberg, David W; Carney, Patricia A

2004-10-01

In recent years, Dartmouth Medical School has increased its commitment to educational research within the school, and in collaboration with other schools across the country. Passionate faculty members with ideas and expertise in particular curricular areas are one critical component needed for a successful educational research program. Other components include an atmosphere that fosters research collaborations and mentoring, and various types of institutional support structures. This same model has effectively supported basic science and clinical research for decades. Because of the complexities involved in studying medical education, Dartmouth Medical School has invested in support structures for educational grant and manuscript development, financial support for pilot projects and partial salary support for investigators and key staff members, and other support targeted toward specific research projects. Ultimately, the goal is to use the results of the school's educational research projects to improve the curriculum through cycles of hypothesis development and testing, providing evidence for subsequent curricular change. When some research findings are relevant and applicable for use in other medical schools, that is an additional benefit of the educational research process. In this report, the authors describe the development of Dartmouth Medical School's infrastructure for supporting educational research, which has helped to accelerate the educational research productivity teaching faculty now enjoy. The authors also address some of the challenges that they anticipate in the near future.

Basic and clinical proteomics from the EU Health Research perspective.

PubMed

Dyląg, Tomasz; Jehenson, Philippe; van de Loo, Jan-Willem; Sanne, Jean-Luc

2010-12-01

The European Union (EU) is one of the main public funders of research in Europe and its major instrument for funding is the Seventh Framework Programme for research and technological development (FP7). The bulk of funding in FP7 goes to collaborative research, with the objective of establishing excellent research projects and networks. Understanding the functions of proteins is essential for the rational development of disease prevention, diagnosis and treatment, therefore the EU has largely invested in proteomics, in particular for technology development, data standardisation and sharing efforts, and the application of proteomics in the clinic. The scientific community, including both academia and industry, is encouraged to apply for FP7 funding so that the EU can even more efficiently support innovative health research and ultimately, bring better healthcare to patients.

Leveraging electronic health records for clinical research.

PubMed

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.

In Situ Resource Utilization Technology Research and Facilities Supporting the NASA's Human Systems Research and Technology Life Support Program

NASA Technical Reports Server (NTRS)

Schlagheck, Ronald A.; Sibille, Laurent; Sacksteder, Kurt; Owens, Chuck

2005-01-01

The NASA Microgravity Science program has transitioned research required in support of NASA s Vision for Space Exploration. Research disciplines including the Materials Science, Fluid Physics and Combustion Science are now being applied toward projects with application in the planetary utilization and transformation of space resources. The scientific and engineering competencies and infrastructure in these traditional fields developed at multiple NASA Centers and by external research partners provide essential capabilities to support the agency s new exploration thrusts including In-Situ Resource Utilization (ISRU). Among the technologies essential to human space exploration, the production of life support consumables, especially oxygen and; radiation shielding; and the harvesting of potentially available water are realistically achieved for long-duration crewed missions only through the use of ISRU. Ongoing research in the physical sciences have produced a body of knowledge relevant to the extraction of oxygen from lunar and planetary regolith and associated reduction of metals and silicon for use meeting manufacturing and repair requirements. Activities being conducted and facilities used in support of various ISRU projects at the Glenn Research Center and Marshall Space Flight Center will be described. The presentation will inform the community of these new research capabilities, opportunities, and challenges to utilize their materials, fluids and combustion science expertise and capabilities to support the vision for space exploration.